1. Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced that the company's President and Chief Executive Officer, Mark Foley, will participate in fireside chats at the Cowen 41st Annual Virtual Healthcare Conference on March 3, 2021 and at the Barclays Global Healthcare Conference on March 9, 2021.

    Interested parties can access the live audio webcast for this conference from the Investor Relations section of the company's website at www.revance.com. The webcast replay will be available after the conclusion of the live presentation for approximately 30 days.

    About Revance Therapeutics, Inc.

    Revance Therapeutics, Inc. is a biotechnology company focused on…

    Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced that the company's President and Chief Executive Officer, Mark Foley, will participate in fireside chats at the Cowen 41st Annual Virtual Healthcare Conference on March 3, 2021 and at the Barclays Global Healthcare Conference on March 9, 2021.

    Interested parties can access the live audio webcast for this conference from the Investor Relations section of the company's website at www.revance.com. The webcast replay will be available after the conclusion of the live presentation for approximately 30 days.

    About Revance Therapeutics, Inc.

    Revance Therapeutics, Inc. is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection. DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval. Revance is also evaluating DaxibotulinumtoxinA for Injection in the full upper face, including glabellar lines, forehead lines and crow's feet, as well as in two therapeutic indications - cervical dystonia and adult upper limb spasticity. To accompany DaxibotulinumtoxinA for Injection, Revance owns a unique portfolio of premium products and services for U.S. aesthetics practices, including the exclusive U.S. distribution rights to the RHA® Collection of dermal fillers, the first and only range of FDA-approved fillers for correction of dynamic facial wrinkles and folds, and the HintMD fintech platform, which provides an integrated smart payment solution that supports aesthetic practice management, practice economics and practice loyalty. Revance has also partnered with Viatris (formerly Mylan N.V.) to develop a biosimilar to BOTOX®, which would compete in the existing short-acting neuromodulator marketplace. Revance is dedicated to making a difference by transforming patient experiences. For more information or to join our team visit us at www.revance.com.

    "Revance Therapeutics" and the Revance logo are registered trademarks of Revance Therapeutics, Inc.

    Resilient Hyaluronic Acid® and RHA® are trademarks of TEOXANE SA.

    BOTOX® is a registered trademark of Allergan, Inc.

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  2. Dublin, Feb. 24, 2021 (GLOBE NEWSWIRE) -- The "Facial Injectable Market - Forecasts from 2020 to 2025" report has been added to ResearchAndMarkets.com's offering.

    The facial injectable market is projected to grow at a CAGR of 14.22% to reach US$21.727 billion by 2025 from US$9.780 billion in 2019. Products pertaining to facial injectables which are also referred to as dermal fillers that are intended to reconstruct, bioengineer facial features as well for facial rejuvenation to rectify wrinkles caused due to the loss of subcutaneous fat over the face that is experienced by individuals as they grow old. The products are necessary for treating early signs of aging or complement facial rejuvenation surgery. Additionally, the growing consciousness…

    Dublin, Feb. 24, 2021 (GLOBE NEWSWIRE) -- The "Facial Injectable Market - Forecasts from 2020 to 2025" report has been added to ResearchAndMarkets.com's offering.



    The facial injectable market is projected to grow at a CAGR of 14.22% to reach US$21.727 billion by 2025 from US$9.780 billion in 2019. Products pertaining to facial injectables which are also referred to as dermal fillers that are intended to reconstruct, bioengineer facial features as well for facial rejuvenation to rectify wrinkles caused due to the loss of subcutaneous fat over the face that is experienced by individuals as they grow old. The products are necessary for treating early signs of aging or complement facial rejuvenation surgery. Additionally, the growing consciousness about appearance along with the increasing pool of geriatric population is the primary driver that is estimated to catapult the facial injectable market to new heights during the forecast period.



    Moreover, the increasing shift towards minimally invasive procedures and continuous developers in glacial rejuvenation is expected to further augment the growth for the same market. Additionally, the rising awareness regarding the accessibility of various products and procedures, which has stemmed due to the increasing number of players entering the facial injectables space across the globe is forecasted to further add to the surge that the market is expected to witness. Besides, the importance of skincare has gained quite a momentum as exemplified by the fact that 71,800 jobs in 2018 were held by skincare specialists, 47% of which were employed by personal care services in the United States. Additionally, the projected employment in 2028 is estimated at 79,600 [Source: U.S. Bureau of Labor Statistics].



    Further, individualistic value-driven rational has superseded the generic mob mentality of the yesteryears which incentivizes today's consumers to look for products that more oriented to themselves. Further, this interest has also fueled investments in various research studies like that of DREAM (Dysport Real-world Evaluation and Measured satisfaction study) carried out by Galderma after which in May 2020, it announced 95% of patients treated with Dysport achieved high levels of satisfaction with two treatments per year, and 97% of patients believed the result of the treatment looked natural. Dysport is a prescription injection for temporary improvement in the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults less than 65 years of age.



    In the same year, HUONS announced that the Korean Ministry of Food and Drug Safety has given it the approval to conduct phase 2 clinical trials for Liztox, its independently developed botulinum toxin (BTX) product that has launched in June 2019, for treating square jaws. Moreover, form the perspective of increasing market reach, in 2020 Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company pioneering innovations in neuromodulators for aesthetic and therapeutic indications, announced the signing of a U.S. distribution agreement with TEOXANE SA.



    Under this agreement, Revance is the exclusive commercialization partner of the Swiss company's modern and innovative Resilient Hyaluronic Acid (RHA) technology. TEOXANE's RHA line of fillers include U.S. Food and Drug Administration (FDA)-approved RHA 2, RHA 3, and RHA 4 products, which include lidocaine. The RHA line was designed using a patented crosslinking method that preserves the hyaluronic acid network for correction of moderate-to-severe dynamic facial wrinkles and folds optimizing strength, stretch, and tissue integration. It provides physicians with a broad range of uniquely designed gels for individualized treatment in the face.



    Further due to the upward trend there has been a new development in the aesthetics armlet particularly that pertaining to the facial Injectable market. For instance, in 2020, despite the COVID 19, Galderma announced that "Restylane Kysse" - it's lip filler lip augmentation product, received FDA. Again, Revance Therapeutics, Inc recently announced that the Biologics License Application (BLA) for DaxibotulinumtoxinA for Injection (DAXI), which is its next generation neuro modular product aimed at treating moderate to severe glabellar (frown) lines, has been accepted for review by the U.S. Food and Drug Administration (FDA).



    In 2019 The HydraFacialT Company announced that it has entered into a partnership with Advanced Dermatology and Cosmetic Surgery, the largest dermatology practice in the United States. Furthermore, Allergan plc (NYSE:AGN) announced that it received U.S. Food and Drug Administration (FDA) approval for the use of Juvederm VOLUMA XC, a hyaluronic acid gel dermal filler, with a TSK STERiGLIDET cannula for cheek augmentation to correct age-related volume deficit in the mid-face in adults over the age of 21 years. In 2018, Restylane Lyft with Lidocaine, by Q-Med AB was approved by FDA for implantation into the deep dermis to superficial subcutis for the correction of moderate to severe facial folds and wrinkles, such as nasolabial folds, subcutaneous to subperiosteal implantation for cheek augmentation and correction of age-related midface contour deficiencies in patients over the age of 21.



    Thus, from the aforesaid, it is evident that the facial injectable market is expected to witness a significant rise during the forecast period, nevertheless, certain adverse effects Viz. allergic reactions, nausea, skin rash, as well as neck and back pain, are expected to deter the growth. Further regularity issues pertaining to botulinum toxin type A, is also expected to pose a hindrance to market growth during the forthcoming years.



    Key Topics Covered:



    1. Introduction

    1.1. Market Definition

    1.2. Market Segmentation



    2. Research Methodology

    2.1. Research Data

    2.2. Assumptions



    3. Executive Summary

    3.1. Research Highlights



    4. Market Dynamics

    4.1. Market Drivers

    4.2. Market Restraints

    4.3. Porters Five Forces Analysis

    4.3.1. Bargaining Power of Suppliers

    4.3.2. Bargaining Power of Buyers

    4.3.3. The threat of New Entrants

    4.3.4. Threat of Substitutes

    4.3.5. Competitive Rivalry in the Industry

    4.4. Industry Value Chain Analysis



    5. Facial Injectable Market Analysis, By Type

    5.1. Introduction

    5.2. Botulinum Toxin

    5.3. Collagen

    5.4. Hyaluronic Acid

    5.5. Particle & Polymer Fillers (PPF)

    5.5.1. Calcium Hydroxyapatite

    5.5.2. Poly-l-Lactic Acid

    5.5.3. Polymethylmethacrylate



    6. Facial Injectable Market Analysis, By Generation

    6.1. Introduction

    6.2. Gen X

    6.3. Boomer

    6.4. Millennials



    7. Facial Injectable Market Analysis, By End-User

    7.1. Introduction

    7.2. Dermatology & Beauty Clinics

    7.3. Hospitals

    7.4. Research Institutes



    8. Facial Injectable Market Analysis, by Geography

    8.1. Introduction

    8.2. North America

    8.2.1. North America Facial Injectable Market Analysis, By Product Type

    8.2.2. North America Facial Injectable Market Analysis, By Generation

    8.2.3. North America Facial Injectable Market Analysis, By End-Users

    8.2.4. By Country

    8.2.4.1. USA

    8.2.4.2. Canada

    8.2.4.3. Mexico

    8.3. South America

    8.3.1. South America Facial Injectable Market Analysis, By Product Type

    8.3.2. South America Facial Injectable Market Analysis, By Generation

    8.3.3. South America Facial Injectable Market Analysis, By End-Users

    8.3.4. By Country

    8.3.4.1. Brazil

    8.3.4.2. Argentina

    8.3.4.3. Others

    8.4. Europe

    8.4.1. Europe Facial Injectable Market Analysis, By Product Type

    8.4.2. Europe Facial Injectable Market Analysis, By Generation

    8.4.3. Europe Facial Injectable Market Analysis, By End-Users

    8.4.4. By Country

    8.4.4.1. Germany

    8.4.4.2. France

    8.4.4.3. United Kingdom

    8.4.4.4. Italy

    8.4.4.5 Others

    8.5. The Middle East and Africa

    8.5.1. Middle East and Africa Facial Injectable Market Analysis, By Product Type

    8.5.2. Middle East and Africa Facial Injectable Market Analysis, By Generation

    8.5.3. Middle East and Africa Facial Injectable Market Analysis, By End-Users

    8.5.4. By Country

    8.5.4.1. Israel

    8.5.4.2. Saudi Arabia

    8.5.4.3. Others

    8.6. Asia Pacific

    8.6.1. Asia Pacific Facial Injectable Market Analysis, By Product Type

    8.6.2. Asia Pacific Facial Injectable Market Analysis, By Generation

    8.6.3. Asia Pacific Facial Injectable Market Analysis, By End-Users

    8.6.4. By Country

    8.6.4.1. China

    8.6.4.2. Japan

    8.6.4.3. South Korea

    8.6.4.4. India

    8.6.4.5. Others



    9. Competitive Environment and Analysis

    9.1. Major Players and Strategy Analysis

    9.2. Emerging Players and Market Lucrativeness

    9.3. Mergers, Acquisitions, Agreements, and Collaborations

    9.4. Vendor Competitiveness Matrix



    10. Company Profiles

    10.1. Allergan (AbbVie Inc)

    10.2. Bausch Health Companies Inc.

    10.3. Bloomage Biotechnology Corporation Limited

    10.4. Galderma

    10.5. Johnson Medical Aesthetics, LLC

    10.6. Merz Pharma

    10.7. Prollenium Medical Technologies

    10.8. Sanofi

    10.9. Sinclair Pharma

    10.10. Suneva Medical



    For more information about this report visit https://www.researchandmarkets.com/r/4fn9up



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  3. - Nolet serves as the Chair of Ambrx's Audit Committee -

    ​Ambrx, a clinical stage biopharmaceutical company using an expanded genetic code to create Engineered Precision Biologics, today announced the appointment of Chris Nolet to the company's Board of Directors. Mr. Nolet brings extensive experience as a long-time audit partner and business advisor in the life sciences industry, and has assumed the role of Chair of Ambrx's Audit Committee.

    "We are delighted that Chris will be joining our Board of Directors given his deep expertise, knowledge base and industry network," said Feng Tian, Ph.D., President and CEO of Ambrx. "His experience in helping transition clinical stage companies into commercially integrated pharmaceutical companies should…

    - Nolet serves as the Chair of Ambrx's Audit Committee -

    ​Ambrx, a clinical stage biopharmaceutical company using an expanded genetic code to create Engineered Precision Biologics, today announced the appointment of Chris Nolet to the company's Board of Directors. Mr. Nolet brings extensive experience as a long-time audit partner and business advisor in the life sciences industry, and has assumed the role of Chair of Ambrx's Audit Committee.

    "We are delighted that Chris will be joining our Board of Directors given his deep expertise, knowledge base and industry network," said Feng Tian, Ph.D., President and CEO of Ambrx. "His experience in helping transition clinical stage companies into commercially integrated pharmaceutical companies should prove invaluable to Ambrx. As Chair of the Audit Committee, he will provide the accounting and financial oversight to support Ambrx through the next stages of the company's growth. I am confident that Chris will prove to be an indispensable board member and look forward to benefiting from his counsel in the years ahead."

    "I am very pleased to join Ambrx's Board at such a pivotal time in the company's history, and to help the development of Ambrx' Engineered Precision Biologics, which could dramatically improve the treatment outcomes for a variety of cancer patients," said Mr. Nolet. "Ambrx recently completed a $200 million private financing round that included some of the world's leading healthcare investors. In addition, Ambrx's lead development candidate, ARX788, has generated promising clinical data, and received Fast Track Designation from the FDA as a potential monotherapy for the treatment of metastatic HER2-positive breast cancer patients."

    Mr. Nolet currently serves on the Boards of Viela Bio (NASDAQ:VIE), where he is Chair of the Audit Committee, PolarityTE, Inc. (NASDAQ:PTE), where he is Chair of the Audit Committee, and Revance Therapeutics (NASDAQ:RVNC), where he is also Chair of the Audit Committee. In addition, Mr. Nolet serves on both the Executive Committee and Finance Committee (Co-Chair) of the California Life Sciences Association (CLSA), and is a former member of the Finance & Investment Committee and Emerging Companies Section of the Biotechnology Innovation Organization.

    Mr. Nolet is the former West Region Life Sciences Industry Leader & Partner at EY, retiring in June of 2019 after more than 38 years in the profession. In addition to serving clients, his responsibilities included leading West Region EY Life Sciences Industry Group, and serving as a member of the Global EY Life Sciences Executive Leadership Group, which established policies and operating strategies for EY Life Sciences practice worldwide. Prior to joining EY, Mr. Nolet was​ ​a partner at PricewaterhouseCoopers where he led the life sciences practice in the western U.S. He holds a B.S. in accounting from San Diego State University and ​is​ a Certified Public Accountant in California (retired).

    About Ambrx

    Ambrx is a clinical stage biopharmaceutical company using an expanded genetic code to create Engineered Precision Biologics. These include next generation antibody drug conjugates (ADCs), bispecifics, targeted immuno-oncology therapies, novel cytokines to modulate the immune system, and long-acting therapeutic peptides for metabolic and cardiovascular disease. Ambrx is advancing a robust portfolio of clinical and preclinical programs optimized for efficacy, safety and ease of use, in multiple therapeutic areas, including its lead product candidate ARX788. In addition, the company has clinical collaborations with Bristol Myers Squibb, Astellas, BeiGene, Sino Biopharma, Elanco and NovoCodex, for drug candidates generated using Ambrx technology. For additional information, please visit www.ambrx.com.

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  4. Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its investigational neuromodulator product, DaxibotulinumtoxinA for Injection, today announced new hire grants totaling 6,601 inducement restricted stock awards ("RSAs") to 1 employee. The RSAs vest over four years, with 25% of the underlying shares vesting on each of the four anniversaries of the applicable vesting commencement date, subject to the new employee's continued service relationship with Revance through the applicable vesting dates.

    The Compensation Committee of Revance's Board of Directors approved the awards as an inducement material to the new employee's employment in accordance with NASDAQ Listing…

    Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its investigational neuromodulator product, DaxibotulinumtoxinA for Injection, today announced new hire grants totaling 6,601 inducement restricted stock awards ("RSAs") to 1 employee. The RSAs vest over four years, with 25% of the underlying shares vesting on each of the four anniversaries of the applicable vesting commencement date, subject to the new employee's continued service relationship with Revance through the applicable vesting dates.

    The Compensation Committee of Revance's Board of Directors approved the awards as an inducement material to the new employee's employment in accordance with NASDAQ Listing Rule 5635(c)(4).

    About Revance Therapeutics, Inc.

    Revance Therapeutics, Inc. is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection. DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval. Revance is also evaluating DaxibotulinumtoxinA for Injection in the full upper face, including glabellar lines, forehead lines and crow's feet, as well as in two therapeutic indications - cervical dystonia and adult upper limb spasticity. To accompany DaxibotulinumtoxinA for Injection, Revance owns a unique portfolio of premium products and services for U.S. aesthetics practices, including the exclusive U.S. distribution rights to the RHA® Collection of dermal fillers, the first and only range of FDA-approved fillers for correction of dynamic facial wrinkles and folds, and the HintMD fintech platform, which includes integrated smart payment, subscription and loyalty digital services. Revance has also partnered with Viatris (formerly Mylan N.V.) to develop a biosimilar to BOTOX®, which would compete in the existing short-acting neuromodulator marketplace. Revance is dedicated to making a difference by transforming patient experiences. For more information or to join our team visit us at www.revance.com.

    "Revance Therapeutics" and the Revance logo are registered trademarks of Revance Therapeutics, Inc.

    RHA resilient hyaluronic acid® and RHA® are trademarks of TEOXANE SA.

    BOTOX® is a registered trademark of Allergan, Inc.

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  5. Data validated efficacy and safety and informs dosing strategy for Phase 3 program

    Achieved key co-primary endpoint on efficacy, with 500U dose demonstrating statistically significant difference from placebo in the Modified Ashworth Score (MAS) improvement from baseline

    Numerical improvement compared with placebo achieved with all three doses on the Physician Global Impression of Change (PGIC) assessment, but did not reach statistical significance with the study's reduced enrollment due to COVID-19

    Median duration of response of at least 24 weeks demonstrated in all three doses (250U, 375U, 500U)

    Treatment was generally safe and well tolerated in all three doses

    Company to discuss results on Fourth Quarter 2020 Earnings Conference

    Data validated efficacy and safety and informs dosing strategy for Phase 3 program

    Achieved key co-primary endpoint on efficacy, with 500U dose demonstrating statistically significant difference from placebo in the Modified Ashworth Score (MAS) improvement from baseline

    Numerical improvement compared with placebo achieved with all three doses on the Physician Global Impression of Change (PGIC) assessment, but did not reach statistical significance with the study's reduced enrollment due to COVID-19

    Median duration of response of at least 24 weeks demonstrated in all three doses (250U, 375U, 500U)

    Treatment was generally safe and well tolerated in all three doses

    Company to discuss results on Fourth Quarter 2020 Earnings Conference Call at 4:30 p.m. ET

    Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced positive topline data from its JUNIPER Phase 2, randomized, double-blind, placebo-controlled, multi-center clinical trial of its investigational drug candidate DaxibotulinumtoxinA for Injection for the treatment of adults with moderate to severe upper limb spasticity.

    The JUNIPER study was designed to evaluate the efficacy and safety of DaxibotulinumtoxinA for Injection for adults with upper limb spasticity after stroke or traumatic brain injury and to identify a dose to advance into a Phase 3 program. Three doses (250 units, 375 units, 500 units) were studied and subjects were randomized in a 1:1:1:1 ratio across the active doses or placebo. The trial was originally designed to include 128 subjects. Due to the ongoing COVID-19 challenges related to continued subject enrollment and the scheduling of in-person study visits, Revance made the decision in June 2020 to curtail enrollment at 83 subjects.

    "As an investigator in the JUNIPER trial, I am delighted to see the efficacy and safety data that will support the advancement of DaxibotulinumtoxinA for Injection in adult upper limb spasticity," said Atul Patel, MD, MHSA, Medical Director, Kansas Institute of Research. "What impresses me most is the duration of effect covering at least 24-weeks across all dose groups studied, while also being well tolerated. The need for longer duration botulinum toxin treatments for upper limb spasticity is considerable, as the frequent re-emergence of symptoms around 12 weeks continues to be a painful, costly and a time-consuming burden for patients. The data indicates that DaxibotulinumtoxinA for Injection has the potential to reduce the frequency of adult upper limb spasticity treatments by up to 50% annually, delivering meaningful pharmacoeconomic benefits, improvement in patients' quality of life, and the opportunity to expand treatment care."

    The study's co-primary endpoints were improvement from baseline in the Modified Ashworth Score (MAS) and the Physician Global Impression of Change (PGIC) score at Week 6. In the JUNIPER study, proof of concept was demonstrated with all three doses being numerically higher than placebo for the improvement in the MAS score, with the 500-unit dose demonstrating a clinically meaningful and statistically significant reduction from baseline in muscle tone versus placebo (p=0.0488). Additionally, each of the three doses demonstrated a numerical improvement compared with placebo on the PGIC assessment but did not reach statistical significance with the reduced enrollment.

    On a key secondary endpoint, DaxibotulinumtoxinA for Injection delivered a median duration of at least 24 weeks across all three doses. Duration of effect was defined as the time from injection (in weeks) until the loss of improvement as measured by the MAS (for the suprahypertonic muscle group or SMG) and the PGIC, or a request for retreatment by the subject.

    All three doses of DaxibotulinumtoxinA for Injection were generally safe and well tolerated with no increase in the incidence of adverse events observed in the higher dose treatment groups. The majority of treatment-related adverse events were mild or moderate in severity and were similar to or lower than those reported in prior botulinum toxin studies in adult upper limb spasticity.

    "I am very proud of our team and their efforts to successfully complete our Phase 2 trial during what has proven to be a very challenging time for trial enrollment and follow up," said Mark J. Foley, President and Chief Executive Officer at Revance. "Although we reduced the subject enrollment size in response to COVID-19 concerns, we were able to generate sufficient data to inform our dosing strategy for our Phase 3 program, while also demonstrating a long duration profile that is consistent across our therapeutic and aesthetic clinical programs. Our next step is to schedule an end-of-Phase 2 meeting with the FDA prior to finalizing a Phase 3 program. I want to thank the patients, investigators, CROs and the Revance team for their time and commitment in making this trial possible."

    Conference Call

    The company plans to discuss the results today during its Fourth Quarter / Year End 2020 Earnings Conference Call at 4:30 p.m. ET. Individuals interested in listening to the conference call may do so by dialing (855) 453-3827 for domestic callers, or (484) 756-4301 for international callers and reference conference ID: 1678310; or from the webcast link in the investor relations section of the company's website at: www.revance.com. A replay of the call will be available beginning February 22, 2021 at 4:30 p.m. PT/7:30 p.m. ET to February 23, 2021 at 4:30 p.m. PT/7:30 p.m. ET. To access the replay, dial (855) 859-2056 or (404) 537-3406 and reference conference ID: 1678310.

    The live webcast can be accessed here and will be available in the investor relations section on the company's website for 30 days following the completion of the call. In light of reduced call center resources during this time of required social-distancing, Revance requests that listeners who do not plan on participating in the question and answer session listen to the live webcast rather than dialing in by phone.

    About JUNIPER Phase 2 Study

    The company's JUNIPER study was a Phase 2, randomized, double-blind, placebo-controlled, parallel group, dose-ranging, multi-center trial to evaluate the efficacy and safety of DaxibotulinumtoxinA for Injection for the treatment of adult upper limb spasticity in adults following stroke or traumatic brain injury. The study was conducted at 30 sites in the United States and has enrolled 83 male and female patients between the age of 18 to 75 years old. Patients were randomized into one of four treatment groups: 275 units, 350 units, 500 units and placebo. The study was designed to run up to 36 weeks, with two co-primary outcome measures: mean change from baseline in muscle tone measured with the MAS in SMG of the elbow, wrist, or finger flexors at Week 6; and mean score of the PGIC at Week 6. The first 73 subjects, who were dosed before enrollment was paused in March due to the COVID-19 pandemic, were followed up for 36 weeks, and the succeeding 10 subjects were followed up to Week 12.

    Results will be submitted for presentation at an upcoming medical congress. Additional information about the JUNIPER Phase 2 study can be found at www.clinicaltrials.gov.

    About Upper Limb Spasticity

    Upper limb spasticity is a neurological condition that affects the ability to move the arms and can affect hands, fingers, wrist, forearm, elbow and shoulder. It occurs most commonly after a stroke or brain injury.2 Although not life-threatening, it can be painful, effecting a patient's ability to perform daily tasks, such as getting dressed and hygiene care. The prevalence of spasticity (upper limb and lower limb spasticity) is estimated to be 12 million people worldwide yet less than 20% of patients seek treatment.3

    Botulinum toxin treatment is the standard of care for management of upper limb spasticity.4 Other treatments include oral and intrathecal muscle relaxants, physical therapy, splints, casts & braces, electrical stimulation, and surgery.2

    Long-acting symptom relief is a current unmet need for upper limb spasticity patients as the benefits of currently approved botulinum toxin treatments lasts for a median duration of approximately 3 months.4 Spasticity, one of the largest of the muscle movement disorder indications, is a $620 million global opportunity that is expected to grow to over $1 billion by 2025.1

    About Revance Therapeutics, Inc.

    Revance Therapeutics, Inc. is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection. DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval. Revance is also evaluating DaxibotulinumtoxinA for Injection in the full upper face, including glabellar lines, forehead lines and crow's feet, as well as in two therapeutic indications - cervical dystonia and adult upper limb spasticity. To accompany DaxibotulinumtoxinA for Injection, Revance owns a unique portfolio of premium products and services for U.S. aesthetics practices, including the exclusive U.S. distribution rights to the RHA® Collection of dermal fillers, the first and only range of FDA-approved fillers for correction of dynamic facial wrinkles and folds, and the HintMD fintech platform, which includes integrated smart payment, subscription and loyalty digital services. Revance has also partnered with Viatris (formerly Mylan N.V.) to develop a biosimilar to BOTOX®, which would compete in the existing short-acting neuromodulator marketplace. Revance is dedicated to making a difference by transforming patient experiences. For more information or to join our team visit us at www.revance.com.

    "Revance Therapeutics" and the Revance logo are registered trademarks of Revance Therapeutics, Inc.

    Resilient Hyaluronic Acid® and RHA® are trademarks of TEOXANE SA.

    BOTOX® is a registered trademark of Allergan, Inc.

    Forward-Looking Statements

    Any statements in this press release that are not statements of historical fact, including statements related to the clinical development of investigational drug candidate DaxibotulinumtoxinA for Injection for the treatment of adults with moderate to severe focal upper limb spasticity, including the JUNIPER study, and the potential benefits of our drug product candidates constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance, events, circumstances or achievements reflected in the forward-looking statements will ever be achieved or occur.

    Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties relate, but are not limited to: the results, timing, costs, and completion of our research and development activities and regulatory approvals, including delays in the approval of our BLA for DaxibotulinumtoxinA for Injection for the treatment of glabellar lines; the uncertain clinical development process; the risk that clinical trials may not have an effective design or generate positive results; the applicability of clinical study results to actual outcomes; our ability to successfully compete with treatments and therapies; our ability to achieve, and the rate and degree of commercial acceptance and the market, size and growth potential of our drug product candidates, if approved; our ability to successfully commercialize our drug product candidates, if approved, and the timing and cost of commercialization activities; our ability to obtain and maintain regulatory approval of our drug product candidates; unanticipated costs or delays in research, development, and commercialization efforts; our ability to develop sales and marketing capabilities; the status of commercial collaborations; our ability to obtain funding for our operations; and other risks. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in our periodic filings with the Securities and Exchange Commission (SEC), including factors described in the section entitled "Risks Factors" on our Form 10-Q filed with the SEC on November 9, 2020. The forward-looking statements in this press release speak only as of the date hereof. We disclaim any obligation to update these forward-looking statements.

    Source: Revance Therapeutics, Inc.

    References:

    1. December 2020 -Decision Resources Group Therapeutic Botulinum Toxin Market Analysis Global 2021
    2. Spasticity. American Association of neurological Surgeons. Retrieved from: https://www.aans.org/en/Patients/Neurosurgical-Conditions-and-Treatments/Spasticity
    3. What is spasticity? Life with Spasticity. Retrieved from: https://lifewithspasticity.com/efinition-and-prevalence#definition.
    4. Simpson. BoNTA Practice Guidelines. Neurology May 2016.

     

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    • Fourth quarter and full year 2020 total product and service revenue of $10.2 million and $13.3 million, respectively
    • First full quarter of RHA® Collection of dermal fillers revenue of $10.0 million
    • Exited 2020 with over $200 million in annualized HintMD processing volume
    • Cash, cash equivalents and short-term investments balance of $436.5 million at year-end, with cash into 2024
    • Today announced positive data from JUNIPER Phase 2 Trial of DaxibotulinumtoxinA for Injection for adult upper limb spasticity
    • Conference call and webcast today at 4:30 p.m. ET

    Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today reported financial results for the fourth quarter…

    • Fourth quarter and full year 2020 total product and service revenue of $10.2 million and $13.3 million, respectively
    • First full quarter of RHA® Collection of dermal fillers revenue of $10.0 million
    • Exited 2020 with over $200 million in annualized HintMD processing volume
    • Cash, cash equivalents and short-term investments balance of $436.5 million at year-end, with cash into 2024
    • Today announced positive data from JUNIPER Phase 2 Trial of DaxibotulinumtoxinA for Injection for adult upper limb spasticity
    • Conference call and webcast today at 4:30 p.m. ET

    Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today reported financial results for the fourth quarter and full year ended December 31, 2020 and provided a corporate update.

    Financial Highlights

    • Revenue for the fourth quarter and full year ended December 31, 2020 was $11.1 million and $15.3 million compared to $0.1 million and $0.4 million for the same periods in 2019, respectively. The increase was primarily due to the commercial launch of the RHA® Collection of dermal fillers and the HintMD fintech platform. Revenue for the fourth quarter included $10.0 million of product revenue from the RHA® Collection of dermal fillers, $0.9 million of collaboration revenue and $0.2 million of service revenue from the HintMD platform.
    • Selling, general and administrative expenses for the fourth quarter and full year ended December 31, 2020 were $55.8 million and $151.8 million compared to $18.8 million and $62.0 million for the same periods in 2019, respectively. The increase was primarily due to headcount related expenses, sales and marketing expenses related to the commercial launch of the RHA® Collection of dermal fillers, and general and administrative expenses related to the HintMD acquisition.
    • Research and development expenses for the fourth quarter and full year ended December 31, 2020 were $26.8 million and $125.8 million compared to $27.5 million and $102.9 million for the same periods in 2019, respectively. The year-over-year increase was primarily due to expenses related to the company's partnerships, pre-commercial manufacturing, the HintMD acquisition and the biologics license application (BLA) for DaxibotulinumtoxinA for Injection.
    • Total operating expenses for the fourth quarter and full year ended December 31, 2020 were $89.1 million and $288.5 million compared to $46.3 million and $164.9 million for the same periods in 2019, respectively, calculated in accordance with U.S. generally accepted accounting principles ("GAAP"). Excluding costs of revenue, depreciation and amortization, stock-based compensation and in-process research and development, non-GAAP operating expenses for the fourth quarter and full year ended December 31, 2020 were $69.2 million and $225.8 million, respectively. GAAP and non-GAAP operating expenses were in-line with previously announced guidance.
    • Net loss for the fourth quarter and full year ended December 31, 2020 was $78.3 million and $282.1 million compared to a net loss of $45.3 million and $159.4 million for the same periods in 2019, respectively.
    • Cash, cash equivalents and short-term investments as of December 31, 2020 were $436.5 million.
    • Net proceeds from the issuance of approximately 3.3 million shares of common stock during and subsequent to the fourth quarter under the company's At-the-Market (ATM) program totaled $90.1 million.

    "The encouraging results from our first full commercial quarter underscore our innovative and differentiated aesthetics portfolio and the traction we are generating with our targeted, prestige launch strategy," said Mark Foley, President and Chief Executive Officer of Revance. "We believe that more providers and consumers are beginning to recognize Revance as a disrupter in the aesthetics industry and our momentum will accelerate as our innovation pipeline reaches commercialization."

    Foley continued, "Earlier today, we were pleased to announce the positive topline data from our JUNIPER Phase 2 trial, supporting the advancement of DaxibotulinumtoxinA for Injection for the treatment of adult upper limb spasticity. We continue to be encouraged by the efficacy, duration and safety profile of DaxibotulinumtoxinA for Injection across our clinical trials and by the drug's potential in establishing a new standard of care for treating muscle movement disorders."

    Foley added, "With our strong balance sheet and anticipated milestones ahead, which includes our first BLA approval for DaxibotulinumtoxinA for Injection, a new product extension for the RHA® Collection, the integration of PayFac into the HintMD platform and the completion of our Phase 3 open-label safety study for cervical dystonia, we expect 2021 to be another exciting year for Revance. I'd like to thank the entire team for their hard work and resilience during the challenging COVID-19 environment and for delivering a transformative year."

    Fourth Quarter Highlights and Subsequent Updates

    Aesthetics Franchise:

    • Completed first full commercial quarter of RHA® Collection of dermal fillers and HintMD fintech platform. At year end, the company had activated approximately 1,000 aesthetic accounts across products and services. Annualized processing volume for HintMD at year end totaled over $200 million.
    • Reported positive efficacy and duration results from a Phase 2 study of DaxibotulinumtoxinA for Injection in upper facial lines. In December, the company announced positive topline efficacy, duration and safety results from its Phase 2 multicenter, open-label study of DaxibotulinumtoxinA for Injection for the combined treatment of upper facial lines, which are comprised of glabellar lines, dynamic forehead lines and lateral canthal lines. The study showed median time to return to baseline wrinkle severity was at least 33 weeks, or 7.6 months.
    • BLA for DaxibotulinumtoxinA for Injection in glabellar lines anticipated in 2021. On November 25, 2020, the company announced that the United States (U.S.) Food and Drug Administration (FDA) deferred a decision on the BLA for DaxibotulinumtoxinA for Injection due to the FDA's inability to conduct an inspection of the company's Northern California manufacturing facility as a result of COVID-19 pandemic travel restrictions. The inspection of the company's manufacturing facility is required by the FDA as part of the BLA approval process. Though the company's BLA is still under review, the FDA did not indicate any further outstanding review issues beyond the pending on-site inspection.

    Therapeutics Franchise:

    • Reported positive data from the JUNIPER Phase 2 trial of DaxibotulinumtoxinA for Injection for upper limb spasticity. The company announced today that the JUNIPER study delivered efficacy, safety and dosing data to warrant advancement of the program to Phase 3. The 500-unit dose demonstrated statistical significance in Modified Ashworth Score (MAS) improvement from baseline and numerical improvement compared to placebo on the Physician Global Impression of Change (PGIC) measure. The median duration in each of the three doses was at least 24 weeks and the drug was generally safe and well-tolerated for all doses.
    • Reported positive results from the ASPEN-1 Phase 3 trial of DaxibotulinumtoxinA for Injection in cervical dystonia. In October, the company announced that the trial met the primary and secondary endpoints for both 125- and 250-Unit doses with high statistical significance. The 125-Unit dose delivered a median duration of 24 weeks while the 250-Unit dose delivered a median duration of 20.3 weeks. The drug was generally safe and well-tolerated at both doses.

    Corporate Highlights:

    • Announced the appointment of two new independent directors to the board. In its continuous effort to ensure that the evolving needs of the board are met with fresh perspectives, diverse skills and broader representation, the company announced today the appointment of Carey O'Connor Kolaja, a fintech and payments thought leader and entrepreneur, and Olivia C. Ware, a successful biotech and pharmaceutical executive, to its Board of Directors. Separately, the company also announced that long-standing directors Phyllis Gardner and Robert "Bob" Byrnes have decided to retire from the board and not stand for re-election at the company's Annual Meeting of Stockholders in 2021, in accordance with the company's new director tenure policy, which aims to enhance board refreshment.
    • Published the company's first Environment, Social, Governance (ESG) report. Revance is committed to building long-term value for all stakeholders. In January 2021, Revance published its inaugural ESG report, detailing its commitments and efforts to build strong corporate governance, and to operate sustainability and responsibly.
    • Expanded workforce and relocated global headquarters. In 2020, Revance expanded its team from 193 employees to over 470 employees after the integration of HintMD and the remote onboarding of additional headcount to support the buildout of the company's commercial and manufacturing infrastructure. Effective January 1, 2021, Revance relocated its global headquarters from Newark, California to Nashville, Tennessee.

    2021 Milestone Expectations

    Aesthetics Franchise:

    • BLA approval for DaxibotulinumtoxinA for Injection in the treatment of glabellar lines anticipated in 2021.
    • The release of the next-generation HintMD fintech platform, including the vertical integration of payment facilitation (PayFac), planned for mid-2021.
    • Our partner, Teoxane SA, submitted the pre-market approval application for RHA® 1 for perioral (lip) lines and is working to obtain FDA approval in the second half 2021. RHA® 1 will be added to Revance's RHA® Collection offering, once approved.

    Therapeutics Franchise:

    • Topline results from the ASPEN-OLS Phase 3 open-label, long-term safety study for cervical dystonia expected in the second half 2021.
    • End-of-Phase 2 meeting with the FDA planned as the next step for upper limb spasticity.

    2021 Financial Outlook

    Revance expects 2021 GAAP operating expenses to be $375 million to $390 million and non-GAAP operating expenses, which exclude costs of revenue, depreciation and amortization and stock-based compensation to be $270 million to $285 million. Revance expects 2021 non-GAAP research and development expense to be $95 million to $105 million. With the current cash, cash equivalents and short-term investments, management projects that the company is funded into 2024.

    Conference Call

    Revance will host a corresponding conference call and a live webcast at 1:30 p.m. PT / 4:30 p.m. ET on February 22, 2021 to discuss the results and provide a business and pipeline update. Individuals interested in listening to the conference call may do so by dialing (855) 453-3827 for domestic callers, or (484) 756-4301 for international callers and reference conference ID: 1678310; or from the webcast link in the investor relations section of the company's website at: www.revance.com.

    A replay of the call will be available beginning February 22, 2021 at 4:30 p.m. PT / 7:30 p.m. ET to February 23, 2021 at 4:30 p.m. PT / 7:30 p.m. ET. To access the replay, dial (855) 859-2056 or (404) 537-3406 and reference conference ID: 1678310. The webcast will be available in the investor relations section on the company's website for 30 days following the completion of the call.

    About Revance Therapeutics, Inc.

    Revance Therapeutics, Inc. is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection. DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval. Revance is also evaluating DaxibotulinumtoxinA for Injection in the full upper face, including glabellar lines, forehead lines and crow's feet, as well as in two therapeutic indications - cervical dystonia and adult upper limb spasticity. To accompany DaxibotulinumtoxinA for Injection, Revance owns a unique portfolio of premium products and services for U.S. aesthetics practices, including the exclusive U.S. distribution rights to the RHA® Collection of dermal fillers, the first and only range of FDA-approved fillers for correction of dynamic facial wrinkles and folds, and the HintMD fintech platform, which provides an integrated smart payment solution that supports aesthetic practice management, practice economics and practice loyalty. Revance has also partnered with Viatris (formerly Mylan N.V.) to develop a biosimilar to BOTOX®, which would compete in the existing short-acting neuromodulator marketplace. Revance is dedicated to making a difference by transforming patient experiences. For more information or to join our team visit us at www.revance.com.

    "Revance Therapeutics" and the Revance logo are registered trademarks of Revance Therapeutics, Inc.

    Resilient Hyaluronic Acid® and RHA® are trademarks of TEOXANE SA.

    BOTOX® is a registered trademark of Allergan, Inc.

    Forward-Looking Statements

    Any statements in this press release that are not statements of historical fact, including statements related to Revance's financial outlook, milestone expectations, expected cash runway and financial performance; statements about our ability to obtain, and the timing relating to, regulatory approval with respect to our drug product candidates, including with respect to DaxibotulinumtoxinA for Injection in glabellar lines; the rate and degree of commercial acceptance, opportunity and growth potential of Teoxane's RHA® Collection of dermal fillers and the HintMD fintech platform, and our product candidates, if approved; ability for our partner, Teoxane SA, to obtain FDA approval for RHA® 1 for perioral (lip) lines, the process and timing of, and ability to complete, the current and anticipated future clinical development of our product candidates; the initiation, design, enrollment, submission, timing and results of our clinical studies, including JUNIPER Phase 2 and ASPEN-1 Phase 3; development of a biosimilar to BOTOX® with our partner, Viatris; statements about our business strategy, timeline and other goals and market for our anticipated products, plans and prospects, including our commercialization plans; and potential benefits of our drug product candidates and our technologies, including the RHA® Collection of dermal fillers and HintMD fintech platform, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance, events, circumstances or achievements reflected in the forward-looking statements will ever be achieved or occur.

    Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties relate, but are not limited to: the results, timing, costs, and completion of our research and development activities and regulatory approvals, including the continuing delay in the FDA's approval of the BLA for DaxibotulinumtoxinA for Injection for the treatment of glabellar lines, including as a result of delays in the site inspection conducted of our manufacturing facility due to COVID-19-related policies and travel restrictions currently in place at the FDA, observations made by the FDA during the site inspection or other reasons; the impact of the COVID-19 pandemic on our manufacturing operations, supply chain, end user demand for our products, commercialization efforts, business operations, clinical trials and other aspects of our business; our ability to manufacture supplies for our product candidates and to acquire supplies of the RHA® Collection of dermal fillers; the uncertain clinical development process; the risk that clinical trials may not have an effective design or generate positive results; the applicability of clinical study results to actual outcomes; our ability to obtain regulatory approval of our drug product candidates; the rate and degree of economic benefit, commercial acceptance and the market, size and growth potential of the RHA® Collection of dermal fillers, the HintMD fintech platform and our drug product candidates, if approved; our ability to successfully commercialize the RHA® Collection of dermal fillers, the HintMD fintech platform and our drug product candidates, if approved, and the timing and cost of commercialization activities; our ability to develop sales and marketing capabilities; the status of commercial collaborations; our ability to obtain funding for our operations; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; and our financial performance, including future revenue, expenses and capital requirements. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in our periodic filings with the Securities and Exchange Commission (SEC), including factors described in the section entitled "Risks Factors" on our Form 10-Q filed with the SEC on November 9, 2020 and in our future filings with the SEC, including, without limitation, our Annual Report on Form 10-K for the year ended December 31, 2020, expected to be filed with the SEC on February 24, 2021. The forward-looking statements in this press release speak only as of the date hereof. We disclaim any obligation to update these forward-looking statements.

    Use of Non-GAAP Financial Measures

    Revance has presented certain non-GAAP financial measures in this release. This release and the reconciliation tables included herein include total non-GAAP operating expense, which exclude costs of revenue, depreciation and amortization, stock-based compensation, and non-cash in-process research and development costs. Revance excludes costs of revenue, depreciation and amortization, stock-based compensation, and non-cash in-process research and development costs because management believes the exclusion of these items is helpful to investors to evaluate Revance's recurring operational performance. Revance management uses these non-GAAP financial measures to monitor and evaluate its operating results and trends on an on-going basis, and internally for operating, budgeting and financial planning purposes. The non-GAAP financial measures should be considered in addition to results prepared in accordance with GAAP but should not be considered a substitute for or superior to GAAP results.

    Certain non-GAAP measures included in this report were not reconciled to the comparable GAAP financial measures because the GAAP measures are not accessible on a forward-looking basis. The company is unable to reconcile these forward-looking non-GAAP financial measures to the most directly comparable GAAP measures without unreasonable efforts because the company is currently unable to predict with a reasonable degree of certainty the type and extent of certain items that would be expected to impact GAAP measures for these periods but would not impact the non-GAAP measures. Such items include costs of revenue, depreciation and amortization, stock-based compensation, and non-cash in-process research and development costs. The unavailable information could have a significant impact on the company's GAAP financial results.

     

    REVANCE THERAPEUTICS, INC.

    Consolidated Balance Sheets

    (In thousands, except share and per share amounts)

    (Unaudited)

     

     

    December 31,

     

    2020

     

     

    2019

     

    ASSETS

    CURRENT ASSETS

     

     

     

    Cash and cash equivalents

    $

    333,558

     

     

     

    $

    171,160

     

     

    Short-term investments

    102,947

     

     

     

    118,955

     

     

    Accounts and other receivables

    1,829

     

     

     

     

     

    Inventories

    5,876

     

     

     

     

     

    Prepaid expenses and other current assets

    5,793

     

     

     

    6,487

     

     

    Total current assets

    450,003

     

     

     

    296,602

     

     

    Property and equipment, net

    17,499

     

     

     

    14,755

     

     

    Goodwill

    146,964

     

     

     

     

     

    Intangible assets, net

    71,343

     

     

     

     

     

    Operating lease right of use assets

    29,632

     

     

     

    26,531

     

     

    Restricted cash

    3,445

     

     

     

    730

     

     

    Other non-current assets

    1,334

     

     

     

    1,669

     

     

    TOTAL ASSETS

    $

    720,220

     

     

     

    $

    340,287

     

     

    LIABILITIES AND STOCKHOLDERS' EQUITY

    CURRENT LIABILITIES

     

     

     

    Accounts payable

    $

    12,657

     

     

     

    $

    8,010

     

     

    Accruals and other current liabilities

    32,938

     

     

     

    18,636

     

     

    Deferred revenue, current portion

    7,851

     

     

     

    7,911

     

     

    Operating lease liabilities, current portion

    4,437

     

     

     

    3,470

     

     

    Derivative liability

    3,081

     

     

     

    2,952

     

     

    Total current liabilities

    60,964

     

     

     

    40,979

     

     

    Convertible senior notes

    180,526

     

     

     

     

     

    Deferred revenue, net of current portion

    77,294

     

     

     

    47,948

     

     

    Operating lease liabilities, net of current portion

    27,146

     

     

     

    25,870

     

     

    TOTAL LIABILITIES

    345,930

     

     

     

    114,797

     

     

    STOCKHOLDERS' EQUITY

     

     

     

    Convertible preferred stock, par value $0.001 per share — 5,000,000 shares authorized, and no shares issued and outstanding as of December 31, 2020 and 2019

     

     

     

     

     

    Common stock, par value $0.001 per share — 95,000,000 shares authorized both as of December 31, 2020 and 2019; 69,178,666 and 52,374,735 shares issued and outstanding as of December 31, 2020 and 2019, respectively

    69

     

     

     

    52

     

     

    Additional paid-in capital

    1,500,514

     

     

     

    1,069,639

     

     

    Accumulated other comprehensive income

     

     

     

    3

     

     

    Accumulated deficit

    (1,126,293

    )

     

     

    (844,204

    )

     

    TOTAL STOCKHOLDERS' EQUITY

    374,290

     

     

     

    225,490

     

     

    TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY

    $

    720,220

     

     

     

    $

    340,287

     

     

     

    REVANCE THERAPEUTICS, INC.

    Consolidated Statements of Operations and Comprehensive Loss

    (In thousands, except share and per share amounts)

    (Unaudited)

     

     

    Quarter Ended December 31,

     

    Year Ended December 31,

     

    2020

     

     

    2019

     

     

    2020

     

     

    2019

     

    Revenue:

     

     

     

     

     

     

     

    Product revenue

    $

    10,009

     

     

     

    $

     

     

     

    $

    12,877

     

     

     

    $

     

     

    Collaboration revenue

    915

     

     

     

    89

     

     

     

    2,031

     

     

     

    413

     

     

    Service revenue

    209

     

     

     

     

     

     

    417

     

     

     

     

     

    Total Revenue

    11,133

     

     

     

    89

     

     

     

    15,325

     

     

     

    413

     

     

    Operating expenses:

     

     

     

     

     

     

     

    Cost of product revenue (exclusive of amortization)

    3,656

     

     

     

     

     

     

    4,758

     

     

     

     

     

    Cost of service revenue (exclusive of amortization)

    7

     

     

     

     

     

     

    11

     

     

     

     

     

    Selling, general and administrative

    55,819

     

     

     

    18,766

     

     

     

    151,846

     

     

     

    62,011

     

     

    Research and development

    26,782

     

     

     

    27,493

     

     

     

    125,795

     

     

     

    102,861

     

     

    Amortization

    2,838

     

     

     

     

     

     

    6,077

     

     

     

     

     

    Total operating expenses

    89,102

     

     

     

    46,259

     

     

     

    288,487

     

     

     

    164,872

     

     

    Loss from operations

    (77,969

    )

     

     

    (46,170

    )

     

     

    (273,162

    )

     

     

    (164,459

    )

     

    Interest income

    1,454

     

     

     

    1,037

     

     

     

    4,322

     

     

     

    5,532

     

     

    Interest expense

    (4,410

    )

     

     

     

     

     

    (15,148

    )

     

     

     

     

    Changes in fair value of derivative liability

    82

     

     

     

    (60

    )

     

     

    (129

    )

     

     

    (199

    )

     

    Other expense, net

    (186

    )

     

     

    (133

    )

     

     

    (592

    )

     

     

    (303

    )

     

    Loss before income taxes

    (81,029

    )

     

     

    (45,326

    )

     

     

    (284,709

    )

     

     

    (159,429

    )

     

    Income tax benefit

    2,720

     

     

     

     

     

     

    2,620

     

     

     

     

     

    Net loss

    (78,309

    )

     

     

    (45,326

    )

     

     

    (282,089

    )

     

     

    (159,429

    )

     

    Unrealized gain (loss) and adjustment on securities included in net loss

     

     

     

    (39

    )

     

     

    (3

    )

     

     

    11

     

     

    Comprehensive loss

    $

    (78,309

    )

     

     

    $

    (45,365

    )

     

     

    $

    (282,092

    )

     

     

    $

    (159,418

    )

     

    Basic and diluted net loss

    $

    (78,309

    )

     

     

    $

    (45,326

    )

     

     

    $

    (282,089

    )

     

     

    $

    (159,429

    )

     

    Basic and diluted net loss per share

    $

    (1.24

    )

     

     

    $

    (0.99

    )

     

     

    $

    (4.86

    )

     

     

    $

    (3.67

    )

     

    Basic and diluted weighted-average number of shares used in computing net loss per share

    63,298,758

     

     

     

    45,626,470

     

     

     

    58,009,162

     

     

     

    43,460,804

     

     

     

    REVANCE THERAPEUTICS, INC.

    Reconciliation of GAAP Operating Expense to Non-GAAP Operating Expense

    (In thousands)

    (Unaudited)

     

     

    Quarter Ended

     

    Year Ended

     

    December 31, 2020

     

    December 31, 2020

    Operating expense:

     

     

     

    GAAP operating expense

    $

    89,102

     

     

     

    $

    288,487

     

     

    Adjustments:

     

     

     

    In-process research and development

     

     

     

    (11,184

    )

     

    Stock-based compensation

    (11,879

    )

     

     

    (36,453

    )

     

    Depreciation and amortization

    (4,319

    )

     

     

    (10,250

    )

     

    Costs of revenue (exclusive of amortization)

    (3,663

    )

     

     

    (4,769

    )

     

    Non-GAAP operating expense

    $

    69,241

     

     

     

    $

    225,831

     

     

     

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  6. Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced the appointment of accomplished biotech and pharmaceutical executive, Olivia C. Ware, and fintech and payments thought leader and entrepreneur, Carey O'Connor Kolaja, to its Board of Directors. The appointments will be made effective on March 1, 2021 for Ms. Kolaja and March 6, 2021, for Ms. Ware.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210222005292/en/

    Olivia C. Ware (Photo: Business Wire)

    Olivia C. Ware (Photo: Business Wire)

    "As we continue to grow and evolve our company strategy, it is critical that we expand the focus and expertise of our board. Olivia's extensive background…

    Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced the appointment of accomplished biotech and pharmaceutical executive, Olivia C. Ware, and fintech and payments thought leader and entrepreneur, Carey O'Connor Kolaja, to its Board of Directors. The appointments will be made effective on March 1, 2021 for Ms. Kolaja and March 6, 2021, for Ms. Ware.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210222005292/en/

    Olivia C. Ware (Photo: Business Wire)

    Olivia C. Ware (Photo: Business Wire)

    "As we continue to grow and evolve our company strategy, it is critical that we expand the focus and expertise of our board. Olivia's extensive background in drug portfolio and program management and Carey's deep experience in fintech and payments strategy and execution will be invaluable to the board and our organization. We welcome Olivia and Carey to the Revance team and look forward to working with them on our strategic growth initiatives for our aesthetics and therapeutics franchises," said Mark J. Foley, President and Chief Executive Officer of Revance.

    The company also announced that long-standing directors Phyllis Gardner and Robert "Bob" Byrnes have decided that they will be retiring from the board and will not stand for re-election at the company's 2021 Annual Meeting of Stockholders as part of the company's 12-year director tenure policy. While the board values director tenure and board continuity, it is also committed to facilitating board refreshment and enhancing diversity. The director tenure policy, established in 2020, aims to ensure that the evolving needs of the board are met with fresh perspectives, skills and reflect broader representation.

    "Phyllis and Bob have been outstanding members of the board and were instrumental in guiding Revance through its evolution for more than a decade," said Angus C. Russell, Chairman of the Board. "Their contributions will benefit Revance for years to come and on behalf of the entire board, we express our sincere appreciation to Phyllis and Bob for their wisdom, counsel and service."

    Ms. Ware brings over 20 years of experience in biotech and pharmaceutical drug development, commercialization and healthcare management, with a long track record of building and launching drugs, portfolio management, and directing programs at all phases of development. As a Senior Vice President at Principia Biopharma, Ms. Ware is the BTK Franchise Head and is also responsible for the Team Leadership and Portfolio Analytics functions. Prior, Ms. Ware led commercial, team leadership and product development at Genentech, and was integral to the launch of several of the world's largest revenue generating drugs, including Rituxan®, Herceptin®, Avastin® and Lucentis®. In addition, Ms. Ware held leadership positions at Proteus Digital Health, CytRx and Baxter Healthcare Corporation. Her expertise also includes developing managed care, pricing and contracting strategy; developing marketing programs for field-based sales teams; and establishing, growing and optimizing organizations for long-term success.

    Ms. Ware is President of Davidson College Board of Visitors and member of the Davidson Board of Trustees. She graduated from Davidson College and received her MBA from the University of North Carolina at Chapel Hill.

    Ms. Kolaja has been a thought leader and executive in the financial services and payment industry for 25 years, helping businesses develop product strategy, optimize operations and drive growth. She is currently the CEO of AU10TIX, the global leader in automated identity intelligence and cyber fraud prevention. Prior, Ms. Kolaja was the Global Chief Product Officer at Citi Fintech and Vice President of Global Consumer Products at PayPal. In these roles she led international teams to design, deploy, and operate global fintech and payments products. Ms. Kolaja is an author and has been featured on FOX Business, CNBC, and industry publications. She was named one of The Top 10 Women in Fintech by Fintech Magazine in 2020 and was recognized by Innotribe as one of the leading Women in Fintech bridging the gender gap.

    Ms. Kolaja is currently the Chairman of Everest Effect, a crisis recovery platform, and a board member for Waves for Water, an international non-profit that aims to expand the availability of clean water around the world. She is a graduate of the University of Indiana Business School, with a BS in Business, and a graduate of the executive program of Stanford University.

    About Revance Therapeutics, Inc.

    Revance Therapeutics, Inc. is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection. DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval. Revance is also evaluating DaxibotulinumtoxinA for Injection in the full upper face, including glabellar lines, forehead lines and crow's feet, as well as in two therapeutic indications - cervical dystonia and adult upper limb spasticity. To accompany DaxibotulinumtoxinA for Injection, Revance owns a unique portfolio of premium products and services for U.S. aesthetics practices, including the exclusive U.S. distribution rights to the RHA® Collection of dermal fillers, the first and only range of FDA-approved fillers for correction of dynamic facial wrinkles and folds, and the HintMD fintech platform, which includes integrated smart payment, subscription and loyalty digital services. Revance has also partnered with Viatris (formerly Mylan N.V.) to develop a biosimilar to BOTOX®, which would compete in the existing short-acting neuromodulator marketplace. Revance is dedicated to making a difference by transforming patient experiences. For more information or to join our team visit us at www.revance.com.

    "Revance Therapeutics" and the Revance logo are registered trademarks of Revance Therapeutics, Inc.

    Resilient Hyaluronic Acid® and RHA® are trademarks of TEOXANE SA.

    BOTOX® is a registered trademark of Allergan, Inc.

    Forward-Looking Statements

    Any statements in this press release that are not statements of historical fact constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance, events, circumstances, or achievements reflected in the forward-looking statements will ever be achieved or occur.

    Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties relate to a variety of economic, competitive, commercial, social, regulatory and operational factors. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this report may be found in our periodic filings with the Securities and Exchange Commission (SEC), including factors described in the section entitled "Risks Factors" on our Form 10-Q filed with the SEC on November 9, 2020. The forward-looking statements in this report speak only as of the date hereof. We disclaim any obligation to update these forward-looking statements.

    "Revance Therapeutics" and the Revance logo are registered trademarks of Revance Therapeutics, Inc.

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  7. Conference Call Scheduled for Monday, February 22, 2021 at 4:30 p.m. ET.

    Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced that the company will release fourth quarter and full year 2020 financial results on Monday, February 22, 2021 after the close of market. Revance will host a corresponding conference call and a live webcast at 1:30 p.m. PT / 4:30 p.m. ET on the same day to discuss the results and provide a business and pipeline update.

    Individuals interested in listening to the conference call may do so by dialing (855) 453-3827 for domestic callers, or (484) 756-4301 for international callers and reference conference ID: 1678310; or from the webcast…

    Conference Call Scheduled for Monday, February 22, 2021 at 4:30 p.m. ET.

    Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced that the company will release fourth quarter and full year 2020 financial results on Monday, February 22, 2021 after the close of market. Revance will host a corresponding conference call and a live webcast at 1:30 p.m. PT / 4:30 p.m. ET on the same day to discuss the results and provide a business and pipeline update.

    Individuals interested in listening to the conference call may do so by dialing (855) 453-3827 for domestic callers, or (484) 756-4301 for international callers and reference conference ID: 1678310; or from the webcast link in the investor relations section of the company's website at: www.revance.com.

    A replay of the call will be available beginning February 22, 2021 at 4:30 p.m. PT / 7:30 p.m. ET to February 23, 2021 at 4:30 p.m. PT / 7:30 p.m. ET. To access the replay, dial (855) 859-2056 or (404) 537-3406 and reference conference ID: 1678310. The webcast will be available in the investor relations section on the company's website for 30 days following the completion of the call.

    In light of reduced call center resources during this time of required social-distancing, Revance requests listeners not planning on participating in Q&A to listen to the live webcast rather than dialing in by phone.

    About Revance Therapeutics, Inc.

    Revance Therapeutics, Inc. is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection. DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval. Revance is also evaluating DaxibotulinumtoxinA for Injection in the full upper face, including glabellar lines, forehead lines and crow's feet, as well as in two therapeutic indications - cervical dystonia and adult upper limb spasticity. To accompany DaxibotulinumtoxinA for Injection, Revance owns a unique portfolio of premium products and services for U.S. aesthetics practices, including the exclusive U.S. distribution rights to the RHA® Collection of dermal fillers, the first and only range of FDA-approved fillers for correction of dynamic facial wrinkles and folds, and the HintMD fintech platform, which includes integrated smart payment, subscription and loyalty digital services. Revance has also partnered with Viatris (formerly Mylan N.V.) to develop a biosimilar to BOTOX®, which would compete in the existing short-acting neuromodulator marketplace. Revance is dedicated to making a difference by transforming patient experiences. For more information or to join our team visit us at www.revance.com.

    "Revance Therapeutics" and the Revance logo are registered trademarks of Revance Therapeutics, Inc.

    Resilient Hyaluronic Acid® and RHA® are trademarks of TEOXANE SA.

    BOTOX® is a registered trademark of Allergan, Inc.

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  8. - Data from an open-label Phase 2 study of the treatment of upper facial lines with DaxibotulinumtoxinA for Injection highlighted –

    - Secondary analysis results from SAKURA, the largest Phase 3 aesthetic neuromodulator clinical program ever conducted for the treatment of glabellar (frown) lines, are being shared –

    - Additional ePoster showcases data evaluating degradation of the RHA® Collection with hyaluronidase compared to a variety of commercially available HA-based gels –

    Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced that three ePosters will be presented at the Maui Derm for Dermatologists 2021 meeting being held in-person at the Grand Wailea…

    - Data from an open-label Phase 2 study of the treatment of upper facial lines with DaxibotulinumtoxinA for Injection highlighted –

    - Secondary analysis results from SAKURA, the largest Phase 3 aesthetic neuromodulator clinical program ever conducted for the treatment of glabellar (frown) lines, are being shared –

    - Additional ePoster showcases data evaluating degradation of the RHA® Collection with hyaluronidase compared to a variety of commercially available HA-based gels –

    Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced that three ePosters will be presented at the Maui Derm for Dermatologists 2021 meeting being held in-person at the Grand Wailea in Maui, Hawaii from January 25-29, 2021 and broadcasted via live-stream for those unable to join in person. The presentations will showcase findings from the open-label Phase 2 study evaluating DaxibotulinumtoxinA for Injection for the simultaneous treatment of moderate to severe upper facial lines (glabellar lines, forehead lines and lateral canthal lines), as well as data demonstrating the progressive effects of DaxibotulinumtoxinA for Injection on static/resting, glabellar lines with repeated treatment as a secondary analysis of data from the SAKURA Phase 3 program. Additionally, results of an in vitro study evaluating the ability of recombinant hyaluronidase to degrade the RHA® Collection of hyaluronic acid based dermal fillers, alongside a number of other commercially available HA fillers will be shared.

    "We continue to build on our existing body of evidence, underscoring the potential of DaxibotulinumtoxinA for Injection to set a new standard in facial aesthetics treatments," said Roman Rubio, Senior Vice President of Clinical Development at Revance. "At Maui Derm 2021, we are excited to present positive results from our Phase 2 upper facial lines study and data from the SAKURA Phase 3 program on static glabellar lines, in addition to the first in vitro data describing the sensitivity of the RHA® Collection to hyaluronidase degradation."

    The following ePosters are currently available to attendees and the abstracts are available online via the Maui Derm website at MauiDerm.com.

    ePosters:

    • Title: Treatment of Upper Facial Lines with DaxibotulinumtoxinA for Injection: Results from an Open-label Phase 2 Study

      Authors and Affiliations: Jeffrey S. Dover, Skincare Physicians, Chestnut Hill Massachusetts; Shannon Humphrey, University of British Columbia, Vancouver, British Columbia; Z. Paul Lorenc, Department of Plastic Surgery, Lenox Hill Hospital, New York New York; Ava Shamban, AVA MD, Santa Monica, California; Todd Gross, Yan Liu, Roman Rubio, Domenico Vitarella, Revance Therapeutics, Inc. Newark, California
    • Title: DaxibotulinumtoxinA for Injection–treated Subjects Show Progressive Improvement in Static Glabellar Lines with Repeated Treatment

      Authors and Affiliations: Richard Glogau, Department of Dermatology, University of California at San Francisco, San Francisco, California; Theda Kontis, Department of Otolaryngology-Head and Neck Surgery, Division of Facial Plastic and Reconstructive Surgery, Johns Hopkins Medical Institutions, Baltimore, Maryland; Yan Liu, Conor J. Gallagher, Revance Therapeutics, Inc. Newark, California
    • Title: An in vitro Kinetic Study of Hyaluronic Acid Filler Enzymatic Degradation to Human Recombinant Hyaluronidase

      Authors and Affiliations: Jimmy Faivre, Teoxane, Mélanie Gallet, Teoxane, Conor Gallagher, Revance Therapeutics, François Bourdon, Teoxane

    About Revance Therapeutics, Inc.

    Revance Therapeutics, Inc. is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection. DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval. Revance is also evaluating DaxibotulinumtoxinA for Injection in the full upper face, including glabellar lines, forehead lines and crow's feet, as well as in two therapeutic indications - cervical dystonia and adult upper limb spasticity. To accompany DaxibotulinumtoxinA for Injection, Revance owns a unique portfolio of premium products and services for U.S. aesthetics practices, including the exclusive U.S. distribution rights to the RHA® Collection of dermal fillers, the first and only range of FDA-approved fillers for correction of dynamic facial wrinkles and folds, and the HintMD fintech platform, which includes integrated smart payment, subscription and loyalty digital services. Revance has also partnered with Viatris (formerly Mylan N.V.) to develop a biosimilar to BOTOX®, which would compete in the existing short-acting neuromodulator marketplace. Revance is dedicated to making a difference by transforming patient experiences. For more information or to join our team visit us at www.revance.com.

    "Revance Therapeutics" and the Revance logo are registered trademarks of Revance Therapeutics, Inc.

    Resilient Hyaluronic Acid® and RHA® are trademarks of TEOXANE SA.

    BOTOX® is a registered trademark of Allergan, Inc.

    Forward-Looking Statements

    Any statements in this press release that are not statements of historical fact, including statements related to development of a biosimilar to BOTOX®; statements about our business strategy, the market for our anticipated products and plans and prospects, and potential benefits of our drug product candidates constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance, events, circumstances or achievements reflected in the forward-looking statements will ever be achieved or occur.

    Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties relate, but are not limited to: the results, timing, costs, and completion of our research and development activities and regulatory approvals, including delays in the approval of our BLA for DaxibotulinumtoxinA for Injection for the treatment of glabellar lines; the uncertain clinical development process; the risk that clinical trials may not have an effective design or generate positive results; the applicability of clinical study results to actual outcomes; our ability to successfully compete with treatments and therapies; our ability to achieve, and the rate and degree of commercial acceptance and the market, size and growth potential of our drug product candidates, if approved; our ability to successfully commercialize our drug product candidates, if approved, and the timing and cost of commercialization activities; our ability to obtain and maintain regulatory approval of our drug product candidates; unanticipated costs or delays in research, development, and commercialization efforts; our ability to develop sales and marketing capabilities; the status of commercial collaborations; our ability to obtain funding for our operations; and other risks. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in our periodic filings with the Securities and Exchange Commission (SEC), including factors described in the section entitled "Risks Factors" on our Form 10-Q filed with the SEC on November 9, 2020. The forward-looking statements in this press release speak only as of the date hereof. We disclaim any obligation to update these forward-looking statements.

    View Full Article Hide Full Article
  9. Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced the release of its inaugural ESG Report, which details the company's commitments and efforts to build strong corporate governance, and operate sustainably and responsibly, including its response to the COVID-19 pandemic and prevailing social issues in 2020. The report was guided by the Sustainability Accounting Standards Board (SASB) framework.

    "At Revance, our aim is to make a positive impact in the world through our products, services and people. As we enter the commercial stage of our evolution our focus on corporate responsibility and sustainability has never been greater," said Mark Foley, President…

    Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced the release of its inaugural ESG Report, which details the company's commitments and efforts to build strong corporate governance, and operate sustainably and responsibly, including its response to the COVID-19 pandemic and prevailing social issues in 2020. The report was guided by the Sustainability Accounting Standards Board (SASB) framework.

    "At Revance, our aim is to make a positive impact in the world through our products, services and people. As we enter the commercial stage of our evolution our focus on corporate responsibility and sustainability has never been greater," said Mark Foley, President and Chief Executive Officer. "To that end, our first ESG report reflects how our core values and commitment to patients, physicians, employees and shareholders shapes our policies and initiatives on governance and sustainability. For us, this is an important step in the right direction and we look forward to working with our stakeholders to build our ESG efforts in the years ahead."

    Revance's key ESG and corporate citizenship priorities include:

    • Leading with business ethics and compliance – commitments to a comprehensive compliance program, ethical competitive business practices and strong corporate governance.
    • Building a great culture– commitments to a safe, healthy and secure work environment, training and supporting employees, being an equal opportunity employer, diversity and inclusion, fair compensation, and social responsibility.
    • Solving unmet patient needs with innovation – commitments to developing innovative, safe and effective drug products to address unmet patient needs in aesthetics and therapeutics categories.

    ESG is overseen by the Nominating and Governance Committee of the Board of Directors.

    The full report can be found on the company's website.

    About Revance Therapeutics, Inc.

    Revance Therapeutics, Inc. is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection. DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval. Revance is also evaluating DaxibotulinumtoxinA for Injection in the full upper face, including glabellar lines, forehead lines and crow's feet, as well as in two therapeutic indications - cervical dystonia and adult upper limb spasticity. To accompany DaxibotulinumtoxinA for Injection, Revance owns a unique portfolio of premium products and services for U.S. aesthetics practices, including the exclusive U.S. distribution rights to the RHA® Collection of dermal fillers, the first and only range of FDA-approved fillers for correction of dynamic facial wrinkles and folds, and the HintMD fintech platform, which includes integrated smart payment, subscription and loyalty digital services. Revance has also partnered with Viatris (formerly Mylan N.V.) to develop a biosimilar to BOTOX®, which would compete in the existing short-acting neuromodulator marketplace. Revance is dedicated to making a difference by transforming patient experiences. For more information or to join our team visit us at www.revance.com.

    "Revance Therapeutics" and the Revance logo are registered trademarks of Revance Therapeutics, Inc.

    Resilient Hyaluronic Acid® and RHA® are trademarks of TEOXANE SA.

    BOTOX® is a registered trademark of Allergan, Inc.

    Forward-Looking Statements

    Any statements in this press release that are not statements of historical fact constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance, events, circumstances, or achievements reflected in the forward-looking statements will ever be achieved or occur.

    Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties relate to a variety of economic, competitive, commercial, social, regulatory and operational factors. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this report may be found in our periodic filings with the Securities and Exchange Commission (SEC), including factors described in the section entitled "Risks Factors" on our Form 10-Q filed with the SEC on November 9, 2020. The forward-looking statements in this report speak only as of the date hereof. We disclaim any obligation to update these forward-looking statements.

    "Revance Therapeutics" and the Revance logo are registered trademarks of Revance Therapeutics, Inc.

    View Full Article Hide Full Article
  10. Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its investigational neuromodulator product, DaxibotulinumtoxinA for Injection, today announced new hire grants totaling an aggregate of 75,400 inducement restricted stock awards ("RSAs") to 15 employees. The RSAs vest over four years, with 25% of the underlying shares vesting on each of the four anniversaries of the applicable vesting commencement date, subject to the new employee's continued service relationship with Revance through the applicable vesting dates.

    The Compensation Committee of Revance's Board of Directors approved the awards as an inducement material to the new employees' employment in accordance…

    Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its investigational neuromodulator product, DaxibotulinumtoxinA for Injection, today announced new hire grants totaling an aggregate of 75,400 inducement restricted stock awards ("RSAs") to 15 employees. The RSAs vest over four years, with 25% of the underlying shares vesting on each of the four anniversaries of the applicable vesting commencement date, subject to the new employee's continued service relationship with Revance through the applicable vesting dates.

    The Compensation Committee of Revance's Board of Directors approved the awards as an inducement material to the new employees' employment in accordance with NASDAQ Listing Rule 5635(c)(4).

    About Revance Therapeutics, Inc.

    Revance Therapeutics, Inc. is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection. DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval. Revance is also evaluating DaxibotulinumtoxinA for Injection in the full upper face, including glabellar lines, forehead lines and crow's feet, as well as in two therapeutic indications - cervical dystonia and adult upper limb spasticity. To accompany DaxibotulinumtoxinA for Injection, Revance owns a unique portfolio of premium products and services for U.S. aesthetics practices, including the exclusive U.S. distribution rights to the RHA® Collection of dermal fillers, the first and only range of FDA-approved fillers for correction of dynamic facial wrinkles and folds, and the HintMD fintech platform, which includes integrated smart payment, subscription and loyalty digital services. Revance has also partnered with Viatris (formerly Mylan N.V.) to develop a biosimilar to BOTOX®, which would compete in the existing short-acting neuromodulator marketplace. Revance is dedicated to making a difference by transforming patient experiences. For more information or to join our team visit us at www.revance.com.

    "Revance Therapeutics" and the Revance logo are registered trademarks of Revance Therapeutics, Inc.

    RHA resilient hyaluronic acid® and RHA® are trademarks of TEOXANE SA.

    BOTOX® is a registered trademark of Allergan, Inc.

    View Full Article Hide Full Article
  11. Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced that the company will participate in the 39th Annual J.P. Morgan Healthcare Conference, a fully virtual management access conference.

    President and Chief Executive Officer, Mark Foley, is scheduled to present on Thursday, January 14, at 12:40 p.m. PT / 3:40 p.m. ET.

    Interested parties can access the live audio webcast for this conference from the Investor Relations section of the company's website at www.revance.com. The webcast replay will be available after the conclusion of the live presentation for approximately 30 days.

    About Revance Therapeutics, Inc.

    Revance Therapeutics, Inc. is a biotechnology…

    Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced that the company will participate in the 39th Annual J.P. Morgan Healthcare Conference, a fully virtual management access conference.

    President and Chief Executive Officer, Mark Foley, is scheduled to present on Thursday, January 14, at 12:40 p.m. PT / 3:40 p.m. ET.

    Interested parties can access the live audio webcast for this conference from the Investor Relations section of the company's website at www.revance.com. The webcast replay will be available after the conclusion of the live presentation for approximately 30 days.

    About Revance Therapeutics, Inc.

    Revance Therapeutics, Inc. is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection. DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval. Revance is also evaluating DaxibotulinumtoxinA for Injection in the full upper face, including glabellar lines, forehead lines and crow's feet, as well as in two therapeutic indications - cervical dystonia and adult upper limb spasticity. To accompany DaxibotulinumtoxinA for Injection, Revance owns a unique portfolio of premium products and services for U.S. aesthetics practices, including the exclusive U.S. distribution rights to the RHA® Collection of dermal fillers, the first and only range of FDA-approved fillers for correction of dynamic facial wrinkles and folds, and the HintMD fintech platform, which includes integrated smart payment, subscription and loyalty digital services. Revance has also partnered with Viatris (formerly Mylan N.V.) to develop a biosimilar to BOTOX®, which would compete in the existing short-acting neuromodulator marketplace. Revance is dedicated to making a difference by transforming patient experiences. For more information or to join our team visit us at www.revance.com.

    "Revance Therapeutics" and the Revance logo are registered trademarks of Revance Therapeutics, Inc.

    Resilient Hyaluronic Acid® and RHA® are trademarks of TEOXANE SA.

    BOTOX® is a registered trademark of Allergan, Inc.

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  12. Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today provided a corporate update, product pipeline timing and anticipated milestones for 2021.

    Financial Update and Key Launch Metrics:

    • Preliminary Unaudited Full Year 2020 RHA® Collection Revenue of Between $12.5 Million and $13.0 Million. The company expects its first full quarter of unaudited RHA® Collection revenue to be between $9.5 million and $10.0 million for the fourth quarter 2020, bringing full year RHA® Collection revenue to be between $12.5 million and $13.0 million. The company launched the RHA® Collection in September 2020.
    • HintMD Processing Volume. The company expects to exit 2020 with an annualized…

    Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today provided a corporate update, product pipeline timing and anticipated milestones for 2021.

    Financial Update and Key Launch Metrics:

    • Preliminary Unaudited Full Year 2020 RHA® Collection Revenue of Between $12.5 Million and $13.0 Million. The company expects its first full quarter of unaudited RHA® Collection revenue to be between $9.5 million and $10.0 million for the fourth quarter 2020, bringing full year RHA® Collection revenue to be between $12.5 million and $13.0 million. The company launched the RHA® Collection in September 2020.
    • HintMD Processing Volume. The company expects to exit 2020 with an annualized run rate over $200.0 million in processing volume.
    • Aesthetic Accounts. The company's sales team activated approximately 1,000 Aesthetic accounts across products and services in 2020.
    • Preliminary Unaudited Full Year 2020 Operating Expenses In-Line with Guidance Range. The company expects its full year 2020 unaudited total operating expenses and adjusted total operating expenses to be in-line with previously announced guidance.
    • Cash Runway Into 2023. The company maintains a strong balance sheet and reaffirms its previously announced expectations to be funded into 2023.

    "Given the challenging environment resulting from the COVID-19 pandemic, I'm incredibly proud of how the Revance organization responded and came together to deliver on a transformational year for the company. In the fourth quarter, our first full quarter of commercialization, we generated strong interest in our RHA® Collection of dermal fillers, validated our targeted launch strategy, and ended the year with an annualized run rate of over $200 million in credit card transaction processing volume on the HintMD platform. On the clinical development side, we also reported positive efficacy, duration and safety results across several different programs for DaxibotulinumtoxinA for Injection," said Mark Foley, President and Chief Executive Officer of Revance. "Our strong cash position, innovative aesthetics product portfolio, and the unique performance profile of our propriety neuromodulator product continue to provide us with a solid foundation to deliver meaningful progress on both our aesthetics and therapeutic franchises as we move forward. In 2021, we hope to receive our first FDA approval for our next-generation neuromodulator, DaxibotulinumtoxinA for Injection, for the treatment of glabellar lines, further refine our therapeutics strategy and continue to execute on our focused and disciplined launch in aesthetics. I want to thank the entire Revance team for their steadfast commitment to the achievement of our goals while prioritizing the health and safety of our entire organization. Even though the ongoing pandemic continues to introduce a level of uncertainty, our momentum is strong, and I look forward to another pivotal year for the company."

    Aesthetics Franchise Update:

    • Biologics License Application (BLA) Approval for DaxibotulinumtoxinA for Injection in the Treatment of Glabellar Lines Anticipated in 2021. On November 25, 2020, the company announced that the United States (U.S.) Food and Drug Administration (FDA) has deferred a decision on the BLA for DaxibotulinumtoxinA for Injection due to the FDA's inability to conduct a required inspection of the company's Northern California manufacturing facility as a result of COVID-19 pandemic travel restrictions. The inspection of the company's manufacturing facility is required by the FDA as part of the BLA approval process. Though the company's BLA is still under review, the FDA did not indicate any further outstanding review issues beyond the pending on-site inspection. The company remains confident in its BLA submission and continues to work proactively with the FDA on a pre-approval inspection as soon as possible in 2021.
    • Positive Upper Facial Lines Phase 2 Open-Label Study (OLS) Results Reported. In December, Revance announced positive topline efficacy, safety and duration of effect results for the combined treatment of DaxibotulinumtoxinA for Injection in glabellar, forehead and lateral canthal lines, showing a median time to return to baseline wrinkle severity of at least 33 weeks (7.6 months) in responders. The company plans to submit the study's results for presentation at the 2021 medical conferences and in peer-reviewed publications.
    • FDA Approval for RHA® 1. Our partner, Teoxane, remains focused on an FDA approval for RHA® 1 for perioral (lip) lines in the second half 2021.
    • HintMD Development. The release of the next-generation HintMD fintech platform, including the vertical integration of payment facilitation (PayFac), is planned for mid-2021.

    Therapeutics Franchise Update:

    • Upcoming Readouts for DaxibotulinumtoxinA for Injection in Muscle Movement Disorders. Topline results from Revance's JUNIPER Phase 2 upper limb spasticity trial are expected in first quarter 2021, while the results from the ASPEN-OLS Phase 3, long-term safety study for cervical dystonia are expected in the second half 2021. Revance expects these results to help inform the direction of its therapeutics franchise, anchored by a potential Supplemental Biologics License Application (sBLA) submission for DaxibotulinumtoxinA for Injection in cervical dystonia in 2022.

    Corporate Update:

    • In 2020, Revance expanded its team to over 470 full time employees to support the buildout of its commercial and manufacturing infrastructure, including the integration of HintMD.
    • In December, in conjunction with the State of Tennessee's Department of Economic and Community Development, Revance announced the company will move its global headquarters to Nashville, effective January 1, 2021. The new headquarters will include a multi-functional training and education center where healthcare providers, employees and other stakeholders can learn about the latest innovations in the company's products and services.
    • In December, Revance also entered into an amended supply agreement with Ajinomoto Bio-Pharma Services for the supply of DaxibotulinumtoxinA for Injection, which will complement its Northern California-based manufacturing location with a second Southern California-based location.

    About Revance Therapeutics, Inc.

    Revance Therapeutics, Inc. is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection. DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval. Revance is also evaluating DaxibotulinumtoxinA for Injection in the full upper face, including glabellar lines, forehead lines and crow's feet, as well as in two therapeutic indications - cervical dystonia and adult upper limb spasticity. To accompany DaxibotulinumtoxinA for Injection, Revance owns a unique portfolio of premium products and services for U.S. aesthetics practices, including the exclusive U.S. distribution rights to the RHA® Collection of dermal fillers, the first and only range of FDA-approved fillers for correction of dynamic facial wrinkles and folds, and the HintMD fintech platform, which includes integrated smart payment, subscription and loyalty digital services. Revance has also partnered with Viatris (formerly Mylan N.V.) to develop a biosimilar to BOTOX®, which would compete in the existing short-acting neuromodulator marketplace. Revance is dedicated to making a difference by transforming patient experiences. For more information or to join our team visit us at www.revance.com or revanceaesthetics.com.

    "Revance Therapeutics" and the Revance logo are registered trademarks of Revance Therapeutics, Inc.

    RHA resilient hyaluronic acid® and RHA® are trademarks of Teoxane SA.

    BOTOX® is a registered trademark of Allergan, Inc.

    Forward-Looking Statements

    Any statements in this press release that are not statements of historical fact, including statements related to the company's financial outlook, run rate, milestone expectations, expected cash runway and financial performance; statements about our ability to obtain, and the timing relating to, regulatory submissions and approvals with respect to our drug product candidates, including with respect to the anticipated approval of DaxibotulinumtoxinA for Injection in glabellar lines and RHA® 1; the timing of the release of the next generation HintMD payments platform; the process and timing of, and ability to complete, the current and anticipated future clinical development of our product candidates including the timing and outcome of such clinical studies and trials; development of a biosimilar to BOTOX®; our ability to effectively and reliably manufacture supplies of DaxibotulinumtoxinA for Injection; the timing of, and benefits related to, moving our global headquarters to Nashville, TN; statements about our business strategy, timeline, other goals and market for our anticipated products and our plans and prospects, including our commercialization plans; and potential benefits of our drug product candidates and our technologies, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance, events, circumstances or achievements reflected in the forward-looking statements will ever be achieved or occur.

    Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties relate, but are not limited to: the results, timing, costs, and completion of our research and development activities and regulatory approvals, including delays in the approval of our BLA for DaxibotulinumtoxinA for Injection for the treatment of glabellar lines, including as a result of COVID-19-related policies and travel restrictions currently in place at the FDA; the impact of the COVID-19 pandemic on our manufacturing operations, supply chain, end user demand for our products, commercialization efforts, business operations, clinical trials and other aspects of our business; our ability to manufacture supplies for our product candidates and to acquire supplies of the RHA® Collection of dermal fillers; the uncertain clinical development process; the risk that clinical trials may not have an effective design or generate positive results; the applicability of clinical study results to actual outcomes; our ability to obtain regulatory approval of our drug product candidates; disruption to our business caused by and unanticipated costs of moving our headquarters to Nashville, TN; our ability to successfully compete with treatments and therapies, our ability to achieve, and the rate and degree of commercial acceptance and the market, size and growth potential of the RHA® Collection of dermal fillers, the HintMD payments platform and our drug product candidates, if approved; our ability to successfully commercialize the RHA® Collection of dermal fillers, the HintMD payments platform and our drug product candidates, if approved, and the timing and cost of commercialization activities; our ability to obtain and maintain regulatory approval of our drug product candidates; unanticipated costs or delays in research, development, and commercialization efforts; our ability to successfully manufacture our drug product candidates; our ability to develop sales and marketing capabilities; the status of commercial collaborations; our ability to obtain funding for our operations; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for financing and our financial performance; and other risks. In addition, our preliminary expectations of our financial results for the period ended December 31, 2020, are unaudited and are based on currently available information. Our financial closing procedures for the three months ended December 31, 2020 have not been completed, and, as a result, we expect that our final results upon completion of our closing procedures for such period may differ from the preliminary estimates included herein. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in our periodic filings with the Securities and Exchange Commission (SEC), including factors described in the section entitled "Risks Factors" on our Form 10-Q filed with the SEC on November 9, 2020. The forward-looking statements in this press release speak only as of the date hereof. We disclaim any obligation to update these forward-looking statements.

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  13. SAN DIEGO and NEWARK, Calif., Dec. 22, 2020 /PRNewswire/ -- Ajinomoto Bio-Pharma Services ("Aji Bio-Pharma"), a leading provider of biopharmaceutical contract development and manufacturing services, and Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, are pleased to announce a strategic commercial manufacturing agreement for the supply of DaxibotulinumtoxinA for Injection.

    DaxibotulinumtoxinA for Injection is currently under Biologics License Application (BLA) review. Aji Bio-Pharma will serve as a dual supply source and provide drug product manufacturing services for Revance at the company's aseptic manufacturing facility in San Diego, California.

    "We are excited to partner with Revance and their efforts to establish a new standard in aesthetic and therapeutic neuromodulator offerings," said Jean-Baptiste Agnus, VP of Sales at Ajinomoto Bio-Pharma Services. "This partnership underscores our commitment to be a leading, trusted, innovative partner to our clients and reinforces our company mission to improve the health of humankind."

    "We are delighted to be partnering with Aji Bio-Pharma for the production of our innovative product and bolstering our supply chain resiliency," said Brian Blagg, Vice President, Engineering & Supply Chain at Revance. "Aji Bio-Pharma's manufacturing infrastructure, long-standing experience and customer-centric service, were important to this collaboration." 

    About Ajinomoto Bio-Pharma Services

    Ajinomoto Bio-Pharma Services is a fully integrated contract development and manufacturing organization with sites in Belgium, United States, Japan, and India, providing comprehensive development, cGMP manufacturing, and aseptic fill finish services for small and large molecule APIs and intermediates. Ajinomoto Bio-Pharma Services offers a broad range of innovative platforms and capabilities for pre-clinical and pilot programs to commercial quantities, including Corynex® protein expression technology, oligonucleotide synthesis, antibody drug conjugations (ADC), high potency APIs (HPAPI), biocatalysis, continuous flow manufacturing and more. Ajinomoto Bio-Pharma Services is dedicated to providing a high level of quality and service to meet our client's needs. Learn more: www.AjiBio-Pharma.com

    About Revance Therapeutics, Inc.

    Revance Therapeutics, Inc. is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection. DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval. Revance is also evaluating DaxibotulinumtoxinA for Injection in the full upper face, including glabellar lines, forehead lines and crow's feet, as well as in two therapeutic indications - cervical dystonia and adult upper limb spasticity. To accompany DaxibotulinumtoxinA for Injection, Revance owns a unique portfolio of premium products and services for U.S. aesthetics practices, including the exclusive U.S. distribution rights to the RHA® Collection of dermal fillers, the first and only range of FDA-approved fillers for correction of dynamic facial wrinkles and folds, and the HintMD fintech platform, which includes integrated smart payment, subscription and loyalty digital services. Revance has also partnered with Viatris (formerly Mylan N.V.) to develop a biosimilar to BOTOX®, which would compete in the existing short-acting neuromodulator marketplace. Revance is dedicated to making a difference by transforming patient experiences. For more information or to join our team visit us at www.revance.com.

    "Revance Therapeutics" and the Revance logo are registered trademarks of Revance Therapeutics, Inc.

    Resilient Hyaluronic Acid® and RHA® are trademarks of TEOXANE SA.

    BOTOX® is a registered trademark of Allergan, Inc.

    Forward-Looking Statements

    Any statements in this press release that are not statements of historical fact, including statements about the therapeutic and commercial potential of DaxibotulinumtoxinA for Injection; Revance's ability to obtain, and the timing relating to, regulatory approval with respect to DaxibotulinumtoxinA for Injection in glabellar lines; Revance's development of a biosimilar to BOTOX®; Revance's business strategy, timeline and other goals for its anticipated products and its plans and prospects, including its manufacturing and commercialization plans; and potential benefits of Revance's drug product candidates, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. You should not rely upon forward-looking statements as predictions of future events. Although Revance believes that the expectations reflected in the forward-looking statements are reasonable, Revance cannot guarantee that the future results, levels of activity, performance, events, circumstances or achievements reflected in the forward-looking statements will ever be achieved or occur.

    Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from Revance's expectations. These risks and uncertainties relate to, but are not limited to: delays in the approval of Revance's biologics license application for DaxibotulinumtoxinA for Injection for the treatment of glabellar lines, including as a result of COVID-19-related policies and travel restrictions currently in place at the FDA; the impact of the COVID-19 pandemic on Revance's or Aji Bio-Pharma's manufacturing operations or supply chain, end user demand for Revance's products, or Revance's commercialization efforts, business operations, clinical trials and other aspects of its business; Revance's or Aji Bio-Pharma's ability to manufacture supplies for Revance's product candidates; the results, timing, costs, and completion of Revance's research and development activities; the uncertain clinical development process; the risk that clinical trials may not have an effective design or generate positive results; the applicability of clinical study results to actual outcomes; Revance's plans to research, develop, and commercialize its drug product candidates; Revance's ability to obtain regulatory approval of its drug product candidates; Revance's ability to successfully commercialize its drug product candidates, if approved, and the timing and cost of commercialization activities; Revance's ability to obtain funding for its operations; Revance's ability to continue obtaining and maintaining intellectual property protection for its drug product candidates; and Revance's financial performance, including future revenue, expenses and capital requirements. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in Revance's periodic filings with the Securities and Exchange Commission (SEC), including factors described in the section entitled "Risks Factors" on Revance's Form 10-Q filed with the SEC on November 9, 2020. The forward-looking statements in this press release speak only as of the date hereof. Revance disclaims any obligation to update these forward-looking statements.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ajinomoto-bio-pharma-services-and-revance-therapeutics-announce-manufacturing-agreement-for-supply-of-daxibotulinumtoxina-for-injection-301197277.html

    SOURCE Ajinomoto Bio-Pharma Services; Revance Therapeutics, Inc.

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  14. Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its investigational neuromodulator product, DaxibotulinumtoxinA for Injection, today announced new hire grants totaling an aggregate of 41,900 inducement restricted stock awards ("RSAs") to 15 employees. The RSAs vest over four years, with 25% of the underlying shares vesting on each of the four anniversaries of the applicable vesting commencement date, subject to the new employee's continued service relationship with Revance through the applicable vesting dates.

    The Compensation Committee of Revance's Board of Directors approved the awards as an inducement material to the new employees' employment in accordance…

    Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its investigational neuromodulator product, DaxibotulinumtoxinA for Injection, today announced new hire grants totaling an aggregate of 41,900 inducement restricted stock awards ("RSAs") to 15 employees. The RSAs vest over four years, with 25% of the underlying shares vesting on each of the four anniversaries of the applicable vesting commencement date, subject to the new employee's continued service relationship with Revance through the applicable vesting dates.

    The Compensation Committee of Revance's Board of Directors approved the awards as an inducement material to the new employees' employment in accordance with NASDAQ Listing Rule 5635(c)(4).

    About Revance Therapeutics, Inc.

    Revance Therapeutics, Inc. is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection. DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval. Revance is also evaluating DaxibotulinumtoxinA for Injection in the full upper face, including glabellar lines, forehead lines and crow's feet, as well as in two therapeutic indications - cervical dystonia and adult upper limb spasticity. To accompany DaxibotulinumtoxinA for Injection, Revance owns a unique portfolio of premium products and services for U.S. aesthetics practices, including the exclusive U.S. distribution rights to the RHA® Collection of dermal fillers, the first and only range of FDA-approved fillers for correction of dynamic facial wrinkles and folds, and the HintMD fintech platform, which includes integrated smart payment, subscription and loyalty digital services. Revance has also partnered with Viatris to develop a biosimilar to BOTOX®, which would compete in the existing short-acting neuromodulator marketplace. Revance is dedicated to making a difference by transforming patient experiences. For more information or to join our team visit us at www.revance.com.

    "Revance Therapeutics" and the Revance logo are registered trademarks of Revance Therapeutics, Inc.

    RHA resilient hyaluronic acid® and RHA® are trademarks of TEOXANE SA.

    BOTOX® is a registered trademark of Allergan, Inc.

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  15. - Open-label study of DaxibotulinumtoxinA for Injection in the combined treatment of glabellar lines, forehead lines and crow's feet lines showed efficacy of none or mild wrinkle severity in at least 92 percent of subjects at Week 4 –

    - Median time to return to baseline wrinkle severity was at least 33 weeks (7.6 months) –

    - Treatment with DaxibotulinumtoxinA for Injection was well tolerated across upper facial regions –

    Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced positive topline efficacy and safety results from its Phase 2 multicenter, open-label study of investigational drug candidate DaxibotulinumtoxinA for Injection for the combined treatment…

    - Open-label study of DaxibotulinumtoxinA for Injection in the combined treatment of glabellar lines, forehead lines and crow's feet lines showed efficacy of none or mild wrinkle severity in at least 92 percent of subjects at Week 4 –

    - Median time to return to baseline wrinkle severity was at least 33 weeks (7.6 months) –

    - Treatment with DaxibotulinumtoxinA for Injection was well tolerated across upper facial regions –

    Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced positive topline efficacy and safety results from its Phase 2 multicenter, open-label study of investigational drug candidate DaxibotulinumtoxinA for Injection for the combined treatment of upper facial lines, which are comprised of glabellar (frown) lines (GL), dynamic forehead lines (FHL) and lateral canthal lines (LCL), commonly known as crow's feet lines.

    In the Phase 2 study, 48 subjects were enrolled to receive a single treatment of DaxibotulinumtoxinA for Injection with a total study duration of 36 weeks. Subjects received 40, 32, and 48 units of DaxibotulinumtoxinA for Injection respectively in the glabellar complex, forehead and lateral canthal areas.

    TREATMENT EFFECT

    The key endpoints for efficacy were the proportion of subjects achieving a score of none or mild wrinkle severity at maximum contraction (maximum frown, eyebrow elevation, and smile effort) at Week 4, as assessed on the Investigator Global Assessment Frown Wrinkle Severity (IGA-FWS), Investigator Global Assessment Forehead Wrinkle Severity (IGA-FHWS), and Investigator Global Assessment Lateral Canthal Wrinkle Severity (IGA-LCWS), respectively.

     

    Proportion of subjects achieving a score of none or mild at Week 4

    Glabellar lines

    95.8 percent

    Forehead lines

    95.8 percent

    Lateral canthal lines

    91.7 percent

    The study measured duration of effect in responders (those who achieved a score of none or mild at Week 4). These duration measures were defined as the median time to return to baseline wrinkle severity or the time to loss of none or mild wrinkle severity, both based on investigator and subject assessments.

     

    Median time to return to baseline

    Median time to loss of none or mild

    Glabellar lines

     

    33.3 weeks

     

    25.0 weeks

    Forehead lines

     

    35.3 weeks

     

    24.0 weeks

    Lateral canthal lines

     

    35.2 weeks

     

    28.1 weeks

    SAFETY RESULTS

    DaxibotulinumtoxinA for Injection was generally safe and well tolerated when all three facial areas were injected simultaneously. There were no treatment-related serious adverse events (SAEs). The most common adverse events (AEs) were injection site erythema (6.3 percent), facial discomfort (4.2 percent) and headache (2.1 percent). No eyelid or brow ptosis was reported.

    PATIENT SATISFACTION RESULTS

    Participants used a 7-point Subject Global Satisfaction with Treatment Questionnaire to rate their satisfaction with treatment of DaxibotulinumtoxinA for Injection. At Week 4, 100 percent of participants reported being at least "Somewhat Satisfied" with the treatment in all three areas, and 83.0 percent, 78.7 percent, and 80.9 percent reported being "Very Satisfied" with the treatment of their glabellar lines, forehead lines, and crow's feet, respectively.

    "The positive results reported today are reflective of the real-world applications of neuromodulators in the upper face and provide an enhanced understanding of the safety and efficacy of DaxibotulinumtoxinA for Injection in the combined treatment of glabellar lines, forehead lines and lateral canthal lines," said Roman Rubio, M.D., Senior Vice President of Clinical Development at Revance. "This full upper face data complements our already reported results from individual dose-ranging studies, and further expands the body of knowledge on our next-generation neuromodulator. As we saw in our other aesthetic and therapeutic clinical trials, DaxibotulinumtoxinA for Injection delivered a meaningful duration of effect, ranging from 24 to 35 weeks, depending on the measure used and indication studied, while being generally well tolerated by patients."

    "Many of my patients are looking for a more enduring treatment of their upper facial lines and wrinkles, as currently available neuromodulators typically only last 10 to 16 weeks, depending on the location within the face," said study investigator Jeffrey S. Dover, MD, FRCPC, co-director of SkinCare Physicians in Chestnut Hill, MA. "I am pleased to see the high patient satisfaction scores for DaxibotulinumtoxinA for Injection and expect a treatment regimen of just two times a year could be a welcome benefit to patients looking for long-lasting treatment."

    Phase 2 Clinical Program in Upper Facial Lines

    Revance's Phase 2, multicenter, open-label study to evaluate the efficacy and safety of DaxibotulinumtoxinA for Injection for the combined treatment of upper facial lines - glabellar (frown) lines, dynamic forehead lines, and lateral canthal lines, or crow's feet - was conducted at eight sites in the United States and Canada and enrolled 48 subjects, 18 years of age and above. Patients received a single DaxibotulinumtoxinA for Injection treatment of 40 units in five sites of the glabella, 32 units in four sites of the forehead and 48 units in six sites (three on each side) of the lateral canthus. After treatment on Day 1, subjects were followed for a minimum of 24 weeks and up to 36 weeks.

    This trial was undertaken in addition to two Phase 2a open-label, dose escalation studies of DaxibotulinumtoxinA for Injection in the treatment of forehead lines following glabellar line injections and crow's feet lines injections. Revance announced positive results from the Phase 2a studies in June 2020. Interim Week 4 data from the Phase 2a studies in forehead lines and crow's feet were used in the final design of this upper facial lines Phase 2 study to optimize dosing and injection patterns.

    In December of 2018, Revance completed a successful SAKURA Phase 3 program for DaxibotulinumtoxinA for Injection in the treatment of glabellar lines, reporting high response rates and 24-weeks duration of effect, based on a median time to loss of none or mild of wrinkle severity. Revance is currently awaiting a decision on the approval of DaxibotulinumtoxinA for Injection for the treatment of glabellar lines by the U.S. Food and Drug Administration, pending a manufacturing site inspection, which was delayed due to COVID-19 travel restrictions.

    More information about the Phase 2 study can be found at www.clinicaltrials.gov.

    About Revance Therapeutics, Inc.

    Revance Therapeutics, Inc. is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection. DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval. Revance is also evaluating DaxibotulinumtoxinA for Injection in the full upper face, including glabellar lines, forehead lines and crow's feet, as well as in two therapeutic indications - cervical dystonia and adult upper limb spasticity. To accompany DaxibotulinumtoxinA for Injection, Revance owns a unique portfolio of premium products and services for U.S. aesthetics practices, including the exclusive U.S. distribution rights to the RHA® Collection of dermal fillers, the first and only range of FDA-approved fillers for correction of dynamic facial wrinkles and folds, and the HintMD fintech platform, which includes integrated smart payment, subscription and loyalty digital services. Revance has also partnered with Viatris (formerly Mylan N.V.) to develop a biosimilar to BOTOX®, which would compete in the existing short-acting neuromodulator marketplace. Revance is dedicated to making a difference by transforming patient experiences. For more information or to join our team visit us at www.revance.com.

    "Revance Therapeutics" and the Revance logo are registered trademarks of Revance Therapeutics, Inc.

    Resilient Hyaluronic Acid® and RHA® are trademarks of TEOXANE SA.

    BOTOX® is a registered trademark of Allergan, Inc.

    Forward-Looking Statements

    Any statements in this press release that are not statements of historical fact, including statements about the commercial potential of DaxibotulinumtoxinA for Injection; the potential value and application of DaxibotulinumtoxinA for Injection in neuromodulator indications; the process and timing of, and ability to complete, current and anticipated future clinical development of our investigational drug product candidates; our ability to obtain, and the timing relating to, regulatory approval with respect to our drug product candidates, including with respect to the anticipated approval of DaxibotulinumtoxinA for Injection in glabellar lines; the rate and degree of commercial interest and acceptance; development of a biosimilar to BOTOX®; our business strategy, timeline and other goals for our anticipated products, plans and prospects, including our commercialization plans; and potential benefits of our drug product candidates, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance, events, circumstances or achievements reflected in the forward-looking statements will ever be achieved or occur.

    Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties relate, but are not limited to: the uncertain clinical development process; the risk that clinical trials may not have an effective design or generate positive results; the applicability of clinical study results to actual outcomes; the rate and degree of commercial acceptance and our ability to successfully commercialize DaxibotulinumtoxinA for Injection, if approved, and the timing and cost of commercialization activities; the status of commercial collaborations; the results and timing of our regulatory approvals; delays in the approval of our BLA for DaxibotulinumtoxinA for Injection for the treatment of glabellar lines due to COVID-19-related policies and travel restrictions currently in place at the FDA; the impact of the COVID-19 pandemic on our manufacturing operations, supply chain, end user demand for our products, commercialization efforts, business operations, clinical trials and other aspects of our business; our ability to obtain funding for our operations; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; and our financial performance, including future revenue, expenses and capital requirements. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in our periodic filings with the Securities and Exchange Commission (SEC), including factors described in the section entitled "Risks Factors" on our Form 10-Q filed with the SEC on November 9, 2020. The forward-looking statements in this press release speak only as of the date hereof. We disclaim any obligation to update these forward-looking statements.

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    • Silicon Valley biotechnology innovator in aesthetics, therapeutics and financial technology
    • Company will invest more than $10 million in Nashville operations
    • Project will create nearly 150 jobs over five years

    Tennessee Gov. Bill Lee, Department of Economic and Community Development Commissioner Bob Rolfe and Revance Therapeutics (NASDAQ:RVNC) officials announced today that the company will relocate its headquarters from Silicon Valley's Newark, California, to Nashville, Tennessee.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201216005367/en/

    Nashville Skyline (Photo: Business Wire)

    Nashville Skyline (Photo: Business Wire)

    As part of the relocation, the biotechnology company will invest more than $10 million and…

    • Silicon Valley biotechnology innovator in aesthetics, therapeutics and financial technology
    • Company will invest more than $10 million in Nashville operations
    • Project will create nearly 150 jobs over five years

    Tennessee Gov. Bill Lee, Department of Economic and Community Development Commissioner Bob Rolfe and Revance Therapeutics (NASDAQ:RVNC) officials announced today that the company will relocate its headquarters from Silicon Valley's Newark, California, to Nashville, Tennessee.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201216005367/en/

    Nashville Skyline (Photo: Business Wire)

    Nashville Skyline (Photo: Business Wire)

    As part of the relocation, the biotechnology company will invest more than $10 million and create nearly 150 jobs over the next five years in addition to the company's more than 450 employees currently located in its California offices and throughout the U.S.

    The new headquarters will include a training and education center where employees, healthcare providers, consumers and patients can learn about the latest innovations in the company's aesthetics, therapeutics and financial technology (fintech) products and services.

    Revance Therapeutics is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation, investigational neuromodulator product, DaxibotulinumtoxinA for Injection. DaxibotulinumtoxinA for Injection is currently under review with the U.S. Food and Drug Administration (FDA) for glabellar (frown) lines and is being evaluated in other aesthetics and therapeutic indications, including cervical dystonia and adult upper limb spasticity.

    Revance has launched a unique portfolio of premium products and services for aesthetics practices, including the exclusive RHA® Collection of dermal fillers, the first and only range of FDA-approved fillers for correction of dynamic facial wrinkles and folds, and HintMD, a fintech platform that offers integrated smart payment, subscription and loyalty services.

    Since 2015, TNECD has supported nearly 80 economic development projects in Davidson County, resulting in more than 23,500 job commitments and approximately $2.3 billion in capital investment.

    QUOTES

    "Any time a business chooses to relocate to Tennessee, it means growth for our economy and new opportunities for our residents. As governor, one of my priorities is ensuring high quality jobs from committed companies, and Revance Therapeutics is doing just that. I welcome them to our state and wish them great success." – Gov. Bill Lee

    "We are pleased to welcome another West Coast, California-based company to Tennessee. Revance Therapeutics is on the cutting edge of biotechnology and will be an asset to Nashville's business landscape. We thank the company for choosing Tennessee for this project and for creating 150 new jobs in Davidson County." – TNECD Commissioner Bob Rolfe

    "We are thrilled to be relocating our corporate headquarters to Nashville as the area will provide the foundation for our new, world-class training and education center and growth initiatives going forward. Nashville is one of the top business growth areas in the U.S. offering an educated, diverse and growing population along with a favorable tax and policy environment for companies like ours, making it an ideal, centralized location for Revance's future growth. We anticipate our corporate relocation to be part of an increased investment in Nashville from other biotechnology and healthcare companies, as innovation and growth defines the city." – Mark J. Foley, president and CEO of Revance

    "TVA and Nashville Electric Service congratulate Revance Therapeutics on its decision to locate its headquarters in Nashville. Helping to foster quality job opportunities and investment in the Valley is fundamental to TVA's mission of service and we are proud to partner with Nashville Area Chamber of Commerce and Tennessee Department of Economic and Community Development to help further that mission and celebrate this announcement." – John Bradley, TVA senior vice president of Economic Development

    "Nashville has become a hub for innovation in healthcare and Revance will be an excellent addition to this community's culture and our regional healthcare portfolio." – Sen. Brenda Gilmore (D-Nashville)

    "We are very excited about the arrival of Revance Therapeutics to Nashville and Davidson County. The prospect of nearly 150 new biotech jobs coming to the area is going to be a great shot in the arm to the local economy. Thanks to the people at Revance, local officials and TNECD for working together to make this happen." – Rep. Harold M. Love, Jr. (D-Nashville)

    About Revance Therapeutics, Inc.

    Revance Therapeutics, Inc. is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection. DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval. Revance is also evaluating DaxibotulinumtoxinA for Injection in the full upper face, including glabellar lines, forehead lines and crow's feet, as well as in two therapeutic indications - cervical dystonia and adult upper limb spasticity. To accompany DaxibotulinumtoxinA for Injection, Revance owns a unique portfolio of premium products and services for U.S. aesthetics practices, including the exclusive U.S. distribution rights to the RHA® Collection of dermal fillers, the first and only range of FDA-approved fillers for correction of dynamic facial wrinkles and folds, and the HintMD fintech platform, which includes integrated smart payment, subscription and loyalty digital services. Revance has also partnered with Viatris (formerly Mylan N.V.) to develop a biosimilar to BOTOX®, which would compete in the existing short-acting neuromodulator marketplace. Revance is dedicated to making a difference by transforming patient experiences. For more information or to join our team visit us at www.revance.com.

    "Revance Therapeutics" and the Revance logo are registered trademarks of Revance Therapeutics, Inc.

    Resilient Hyaluronic Acid® and RHA® are trademarks of TEOXANE SA.

    BOTOX® is a registered trademark of Allergan, Inc.

    About the Tennessee Department of Economic and Community Development

    The Tennessee Department of Economic and Community Development's mission is to develop strategies that help make Tennessee the No. 1 location in the Southeast for high quality jobs. To grow and strengthen Tennessee, the department seeks to attract new corporate investment to the state and works with Tennessee companies to facilitate expansion and economic growth. Find us on the web: tnecd.com. Follow us on Twitter and Instagram: @tnecd. Like us on Facebook: facebook.com/tnecd.

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  16. Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced that the United States (U.S.) Food and Drug Administration (FDA) has deferred a decision on the Biologics License Application (BLA) for DaxibotulinumtoxinA for Injection, an investigational neuromodulator product for the treatment of moderate to severe glabellar (frown) lines.

    In a communication received on November 24, 2020, the FDA reiterated that an inspection of the company's manufacturing facility is required as part of the BLA approval process. The Agency was unable to conduct a required inspection of the company's Northern California manufacturing facility due to the Agency's travel restrictions…

    Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced that the United States (U.S.) Food and Drug Administration (FDA) has deferred a decision on the Biologics License Application (BLA) for DaxibotulinumtoxinA for Injection, an investigational neuromodulator product for the treatment of moderate to severe glabellar (frown) lines.

    In a communication received on November 24, 2020, the FDA reiterated that an inspection of the company's manufacturing facility is required as part of the BLA approval process. The Agency was unable to conduct a required inspection of the company's Northern California manufacturing facility due to the Agency's travel restrictions associated with the COVID-19 pandemic. Revance confirmed with the FDA that their communication was not a Complete Response Letter.

    Though the company's BLA is still under review, the FDA did not indicate there are any other review issues at this time, beyond the on-site inspection. The FDA stated they are actively working to define an approach for scheduling outstanding inspections, once safe travel may resume and based on public health need and other factors.

    "We appreciate FDA's engagement on the Chemistry, Manufacturing and Controls (CMC), non-clinical, clinical and labeling sections of our BLA, particularly given the unique and unprecedented situation we are in as a result of the COVID-19 pandemic. We look forward to continued interaction with the Agency and remain ready to support FDA's pre-approval inspection as soon as possible. We are fortunate that we manufacture our product at a single location in the U.S., which should put us at an advantage compared to international manufacturing locations once travel resumes," said Mark J. Foley, President and Chief Executive Officer. "As stated in our third quarter earnings, with the addition of the RHA® Collection of dermal fillers and acquisition of the HintMD fintech platform earlier this year, we believe the company is in an excellent position, both commercially and financially, to weather a change to the timing of this potential approval."

    DaxibotulinumtoxinA for Injection is an investigational agent that combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. In the first quarter of 2020, Revance announced that the BLA for DaxibotulinumtoxinA for Injection had been accepted for review by the FDA and the company had been given a Prescription Drug User Fee Act (PDUFA) target action date of November 25, 2020. The submission was based on results from the largest aesthetic neuromodulator clinical program ever conducted for the treatment of glabellar (frown) lines, including the SAKURA 1, 2 and 3 Phase 3 clinical studies.

    About Revance Therapeutics, Inc.

    Revance Therapeutics, Inc. is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection. DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval. Revance is also evaluating DaxibotulinumtoxinA for Injection in the full upper face, including glabellar lines, forehead lines and crow's feet, as well as in two therapeutic indications - cervical dystonia and adult upper limb spasticity. To accompany DaxibotulinumtoxinA for Injection, Revance owns a unique portfolio of premium products and services for U.S. aesthetics practices, including the exclusive U.S. distribution rights to the RHA® Collection of dermal fillers, the first and only range of FDA-approved fillers for correction of dynamic facial wrinkles and folds, and the HintMD fintech platform, which includes integrated smart payment, subscription and loyalty digital services. Revance has also partnered with Viatris (formerly Mylan N.V.) to develop a biosimilar to BOTOX®, which would compete in the existing short-acting neuromodulator marketplace. Revance is dedicated to making a difference by transforming patient experiences. For more information or to join our team visit us at www.revance.com.

    "Revance Therapeutics" and the Revance logo are registered trademarks of Revance Therapeutics, Inc.

    Resilient Hyaluronic Acid® and RHA® are trademarks of TEOXANE SA.

    BOTOX® is a registered trademark of Allergan, Inc.

    Forward-Looking Statement: Revance Therapeutics

    Any statements in this press release that are not statements of historical fact, including statements related to statements about our ability to obtain, and the timing relating to, regulatory approval with respect to DaxibotulinumtoxinA for Injection in glabellar lines and the expected PDUFA date; the inspection by the FDA of our manufacturing facility in connection with the BLA approval process, including the timing and outcome of and factors impacting the inspection; our financial performance; our commercial potential; development of a biosimilar to BOTOX®; and statements about our business strategy, timeline and other goals, plans and prospects, including our commercialization plans, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance, events, circumstances, or achievements reflected in the forward-looking statements will ever be achieved or occur.

    Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties relate, but are not limited to: the results and timing of our regulatory approvals; delays in the approval of our BLA for DaxibotulinumtoxinA for Injection for the treatment of glabellar lines due to COVID-19-related policies and travel restrictions currently in place at the FDA; the impact of the COVID-19 pandemic on our manufacturing operations, supply chain, end user demand for our products, commercialization efforts, business operations, clinical trials and other aspects of our business; our ability to manufacture supplies for our product candidates and to acquire supplies of the RHA® Collection of dermal fillers; the uncertain clinical development process; the risk that clinical trials may not have an effective design or generate positive results; the applicability of clinical study results to actual outcomes; our ability to obtain regulatory approval of our drug product candidates; whether the HintMD acquisition and Teoxane agreement will provide the anticipated economic and other benefits; the rate and degree of commercial acceptance and the market, size and growth potential of the RHA® Collection of dermal fillers, the HintMD payments platform and our drug product candidates, if approved; our ability to successfully commercialize the RHA® Collection of dermal fillers, the HintMD payments platform and our drug product candidates, if approved, and the timing and cost of commercialization activities; our ability to develop sales and marketing capabilities; the status of commercial collaborations; our ability to obtain funding for our operations; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; and our financial performance, including future revenue, expenses and capital requirements. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in our periodic filings with the Securities and Exchange Commission (SEC), including factors described in the section entitled "Risks Factors" on our Form 10-Q filed with the SEC on November 9, 2020. The forward-looking statements in this press release speak only as of the date hereof. We disclaim any obligation to update these forward-looking statements.

    "Revance Therapeutics" and the Revance logo are registered trademarks of Revance Therapeutics, Inc.

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  17. Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced that the company's President and Chief Executive Officer, Mark Foley, will participate in a fireside chat at the Piper Sandler 32nd Annual Virtual Healthcare Conference.

    The fireside chat will be available online beginning December 1 in the investor relations section of the company's website at www.revance.com. The virtual conference will be held from December 1-3, 2020.

    About Revance Therapeutics, Inc.

    Revance Therapeutics, Inc. is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection…

    Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced that the company's President and Chief Executive Officer, Mark Foley, will participate in a fireside chat at the Piper Sandler 32nd Annual Virtual Healthcare Conference.

    The fireside chat will be available online beginning December 1 in the investor relations section of the company's website at www.revance.com. The virtual conference will be held from December 1-3, 2020.

    About Revance Therapeutics, Inc.

    Revance Therapeutics, Inc. is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection. DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval in 2020. Revance is also evaluating DaxibotulinumtoxinA for Injection in the full upper face, including glabellar lines, forehead lines and crow's feet, as well as in two therapeutic indications - cervical dystonia and adult upper limb spasticity. To accompany DaxibotulinumtoxinA for Injection, Revance has built a unique portfolio of premium products and services for U.S. aesthetics practices, including the RHA® Collection of dermal fillers in the U.S., the first and only range of FDA-approved fillers for correction of dynamic facial wrinkles and folds, and the HintMD fintech platform, which includes integrated smart payment, subscription and loyalty digital services. Revance has also partnered with Viatris (formerly Mylan N.V.) to develop a biosimilar to BOTOX®, which would compete in the existing short-acting neuromodulator marketplace. Revance is dedicated to making a difference by transforming patient experiences. For more information or to join our team visit us at www.revance.com.

    "Revance Therapeutics" and the Revance logo are registered trademarks of Revance Therapeutics, Inc.

    RHA resilient hyaluronic acid® and RHA® are trademarks of TEOXANE SA.

    BOTOX® is a registered trademark of Allergan, Inc.

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  18. Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its investigational neuromodulator product, DaxibotulinumtoxinA for Injection, today announced new hire grants totaling an aggregate of 40,500 inducement restricted stock awards ("RSAs") to nine employees. The RSAs vest over four years, with 25% of the underlying shares vesting on each of the four anniversaries of the applicable vesting commencement date, subject to the new employee's continued service relationship with Revance through the applicable vesting dates.

    The Compensation Committee of Revance's Board of Directors approved the awards as an inducement material to the new employees' employment in accordance…

    Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its investigational neuromodulator product, DaxibotulinumtoxinA for Injection, today announced new hire grants totaling an aggregate of 40,500 inducement restricted stock awards ("RSAs") to nine employees. The RSAs vest over four years, with 25% of the underlying shares vesting on each of the four anniversaries of the applicable vesting commencement date, subject to the new employee's continued service relationship with Revance through the applicable vesting dates.

    The Compensation Committee of Revance's Board of Directors approved the awards as an inducement material to the new employees' employment in accordance with NASDAQ Listing Rule 5635(c)(4).

    About Revance Therapeutics, Inc.

    Revance Therapeutics, Inc. is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection. DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval in 2020. Revance is also evaluating DaxibotulinumtoxinA for Injection in the full upper face, including glabellar lines, forehead lines and crow's feet, as well as in two therapeutic indications - cervical dystonia and adult upper limb spasticity. To accompany DaxibotulinumtoxinA for Injection, Revance owns a unique portfolio of premium products and services for U.S. aesthetics practices, including the exclusive U.S. distribution rights to the RHA® Collection of dermal fillers, the first and only range of FDA-approved fillers for correction of dynamic facial wrinkles and folds, and the HintMD fintech platform, which includes integrated smart payment, subscription and loyalty digital services. Revance has also partnered with Viatris to develop a biosimilar to BOTOX®, which would compete in the existing short-acting neuromodulator marketplace. Revance is dedicated to making a difference by transforming patient experiences. For more information or to join our team visit us at www.revance.com.

    "Revance Therapeutics" and the Revance logo are registered trademarks of Revance Therapeutics, Inc.

    RHA resilient hyaluronic acid® and RHA® are trademarks of TEOXANE SA.

    BOTOX® is a registered trademark of Allergan, Inc.

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  19. Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced that the company will participate in the Stifel 2020 Virtual Healthcare Conference, a fully virtual management access conference, taking place November 16-18.

    President and Chief Executive Officer, Mark Foley, is scheduled to participate in a virtual fireside chat on Tuesday, November 17, at 11:00 a.m. PT / 2:00 p.m. ET.

    Interested parties can access the live audio webcast for this conference from the Investor Relations section of the company's website at www.revance.com. The webcast replay will be available after the conclusion of the live presentation for approximately 30 days.

    About Revance Therapeutics,

    Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced that the company will participate in the Stifel 2020 Virtual Healthcare Conference, a fully virtual management access conference, taking place November 16-18.

    President and Chief Executive Officer, Mark Foley, is scheduled to participate in a virtual fireside chat on Tuesday, November 17, at 11:00 a.m. PT / 2:00 p.m. ET.

    Interested parties can access the live audio webcast for this conference from the Investor Relations section of the company's website at www.revance.com. The webcast replay will be available after the conclusion of the live presentation for approximately 30 days.

    About Revance Therapeutics, Inc.

    Revance Therapeutics, Inc. is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection. DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval in 2020. Revance is also evaluating DaxibotulinumtoxinA for Injection in the full upper face, including glabellar lines, forehead lines and crow's feet, as well as in three therapeutic indications - cervical dystonia, adult upper limb spasticity and plantar fasciitis. To accompany DaxibotulinumtoxinA for Injection, Revance has built a unique portfolio of premium products and services for U.S. aesthetics practices, including the RHA® Collection of dermal fillers in the U.S., the first and only range of FDA-approved fillers for correction of dynamic facial wrinkles and folds, and the HintMD fintech platform, which includes integrated smart payment, subscription and loyalty digital services. Revance has also partnered with Mylan N.V. to develop a biosimilar to BOTOX®, which would compete in the existing short-acting neuromodulator marketplace. Revance is dedicated to making a difference by transforming patient experiences. For more information or to join our team visit us at www.revance.com.

    "Revance Therapeutics" and the Revance logo are registered trademarks of Revance Therapeutics, Inc.

    RHA resilient hyaluronic acid® and RHA® are trademarks of TEOXANE SA.

    BOTOX® is a registered trademark of Allergan, Inc.

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  20. - Conference call and webcast today at 4:30 p.m. ET -

    Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today reported financial results for the quarter ended September 30, 2020, and provided a corporate update.

    Third Quarter 2020 and Subsequent Updates

    Revance Aesthetics

    • Company's First Commercial Quarter – Successfully Launched Prestige Aesthetics Portfolio with the RHA® Collection of Dermal Fillers and HintMD Platform. In August, Revance announced that the company's field force was established and would begin introducing its prestige Revance Aesthetics portfolio. In September, Revance began selling the RHA® Collection of dermal fillers and the HintMD financial…

    - Conference call and webcast today at 4:30 p.m. ET -

    Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today reported financial results for the quarter ended September 30, 2020, and provided a corporate update.

    Third Quarter 2020 and Subsequent Updates

    Revance Aesthetics

    • Company's First Commercial Quarter – Successfully Launched Prestige Aesthetics Portfolio with the RHA® Collection of Dermal Fillers and HintMD Platform. In August, Revance announced that the company's field force was established and would begin introducing its prestige Revance Aesthetics portfolio. In September, Revance began selling the RHA® Collection of dermal fillers and the HintMD financial technology (fintech) platform in select accounts in the U.S., with initial launch activities generating $3.0 million in revenues in the third quarter.
    • Due to COVID-Related Travel Restrictions, Required Inspection of the Revance Manufacturing Site by the U.S. Food and Drug Administration (FDA) has Not Been Scheduled. Today, Revance disclosed that, with 16 days left before its Prescription Drug User Fee Act (PDUFA) action date of November 25, 2020, the FDA has not scheduled a manufacturing site inspection related to the company's Biologics License Application (BLA) for DaxibotulinumtoxinA for Injection in the treatment of moderate to severe glabellar (frown) lines. The FDA has indicated that an inspection of the Newark, Calif. manufacturing site will be required prior to approval. Revance continues to work proactively with the FDA to secure an inspection at the earliest possible time.
    • Announced Two Peer-Reviewed Publications Reporting Safety and Efficacy Results from the SAKURA 3 Open-Label Safety Study in Dermatologic Surgery. In August, Revance announced the publication of two separate peer-reviewed articles in Dermatologic Surgery, the official journal of the American Society for Dermatologic Surgery (ASDS). The two peer-reviewed publications reported efficacy data as well as detailed safety results from the SAKURA 3 Phase 3 open-label, long-term safety study.
    • Presented Three New Abstracts Evaluating DaxibotulinumtoxinA for Injection and Two ePosters Evaluating the RHA® Collection During the American Society for Dermatologic Surgery (ASDS) Virtual Annual Meeting. In October, Revance presented three new abstracts and two ePoster results at the American Society for Dermatologic Surgery (ASDS) Virtual Annual Meeting. Presented data showcased novel findings from the SAKURA Phase 3 program evaluating DaxibotulinumtoxinA for Injection for the treatment of moderate or severe glabellar (frown) lines, as well as a 4-week interim analysis from the Phase 2a open-label study for the treatment of moderate to severe lateral canthal lines (LCL), commonly known as crow's feet lines. The ePosters focused on the unique properties of the RHA® Collection of hyaluronic acid-based dermal fillers.

    Revance Therapeutics

    • Announced Positive Results from ASPEN-1 Phase 3 Trial of DaxibotulinumtoxinA for Injection in Cervical Dystonia. In October, Revance announced positive topline results from its ASPEN-1 Phase 3 randomized, double-blind, placebo-controlled, parallel group clinical trial for its investigational drug candidate DaxibotulinumtoxinA for Injection for the treatment of cervical dystonia, a chronic and debilitating neurologic condition affecting the muscles of the neck. This pivotal study, which enrolled a total of 301 subjects at 60 sites in the U.S., Canada and Europe, met the primary and secondary endpoints for both 125- and 250-Unit doses with high statistical significance. The 125-Unit dose delivered a median duration of 24 weeks. The drug was generally safe and well-tolerated at both doses, with an encouraging safety profile.
    • Reported Topline Results from Phase 2 Plantar Fasciitis Trial. Today, Revance reported results from its Phase 2 prospective, randomized, double-blind, multi-center, placebo-controlled trial evaluating the safety and efficacy for two doses of DaxibotulinumtoxinA for Injection for the treatment of plantar fasciitis. Although both doses demonstrated pain relief on the Numeric Pain Rating Scale that was numerically greater from the baseline than placebo, neither was statistically significant. As such, Revance will focus its efforts on indications for muscle movement and pain disorder indications where the use of neuromodulators is well-established.

    "The third quarter of 2020 marked a significant milestone in the company's history as Revance successfully transitioned to a fully integrated commercial enterprise. I am very pleased with the positive, early market feedback on our RHA® Collection of dermal fillers and HintMD fintech platform. We have assembled a portfolio of differentiated and unique assets for our aesthetics franchise and we believe we have the right commercial team and strategy for success," said Mark Foley, President and CEO.

    "During the quarter, we also announced positive Phase 3 results from our ASPEN-1 study in cervical dystonia, which lays the foundation for the creation of a strong therapeutics franchise. While we were disappointed with the results from our Phase 2 plantar fasciitis trial, this was an opportunistic indication where there are no FDA approved pharmacological treatments. We will now primarily focus our therapeutic efforts on established neuromodulator indications, including muscle movement disorders where our ASPEN-1 results are a source of confidence. As such, we look forward to announcing topline results from our JUNIPER Phase 2 upper limb spasticity trial in the first quarter of 2021."

    "Finally, today, we shared that the FDA has not yet scheduled a site inspection at our Newark, CA manufacturing facility as part of our BLA submission. We understand this is due to COVID-19-related travel restrictions at the Agency. While there is still time for an inspection to take place before our PDUFA date of November 25th, and though the company continues to work proactively with the Agency, we felt it was appropriate to provide an update. Importantly, should the anticipated approval of DaxibotulinumtoxinA for Injection in glabellar lines be delayed, we believe that Revance is in a strong position, both commercially and financially, to weather any near-term change in timing. Just as importantly, we remain confident in the strength of our BLA submission for DaxibotulinumtoxinA for Injection in the treatment of glabellar lines."

    Financial Highlights

    Cash, cash equivalents and short-term investments as of September 30, 2020 were $435.8 million.

    Revenue for the quarter ended September 30, 2020 was $3.8 million compared to $46 thousand for the same period in 2019. Revenue for the nine months ended September 30, 2020 was $4.2 million compared to $0.3 million for the same period in 2019. For the quarter ended September 30, 2020, product revenue was $2.8 million, service revenue from the HintMD platform was $0.2 million and collaboration revenue was $0.8 million.

    Research and development expenses for the three and nine months ended September 30, 2020 were $29.1 million and $96.0 million compared to $25.9 million and $75.4 million for the same periods in 2019, respectively. The increase in research and development expenses were primarily due to pre-commercial manufacturing, quality, the inclusion of HintMD for the first time, and inspection activities related to DaxibotulinumtoxinA for Injection.

    Selling, general and administrative expenses for the three and nine months ended September 30, 2020 were $48.2 million and $99.0 million compared to $16.7 million and $43.2 million for the same periods in 2019, respectively. The increase in selling, general and administrative expenses is primarily due to increased costs related to selling and marketing expenses related to the launch the RHA® Collection and HintMD platform service offerings, pre-commercial activities for DaxibotulinumtoxinA for Injection, HintMD transaction and integration costs, and personnel and infrastructure build-out.

    Total operating expenses for the three and nine months ended September 30, 2020 were $81.0 million and $199.4 million compared to $42.6 million and $118.6 million for the same periods in 2019, respectively. Stock-based compensation for the three and nine months ended September 30, 2020 was $10.7 million and $24.6 million, respectively. When excluding costs of revenue, depreciation and amortization, stock-based compensation, and non-cash in-process research and development, total operating expenses for the three and nine months ended September 30, 2020 were $65.4 million and $156.6 million, respectively.

    Net loss for the three and nine months ended September 30, 2020 was $81.3 million and $203.8 million compared to $41.4 million and $114.1 million for the same periods in 2019, respectively.

    Near-Term Milestone Expectations

    Aesthetics:

    • PDUFA date of November 25, 2020, for potential FDA approval of DaxibotulinumtoxinA for Injection in the treatment of moderate to severe glabellar (frown) lines. However, this timing may be delayed as the FDA has not yet scheduled a site inspection at our Newark, CA manufacturing facility as part of our BLA submission.
    • Topline results from Phase 2 open-label, dose-escalation study of DaxibotulinumtoxinA for Injection in upper facial lines expected in December 2020.

    Therapeutics:

    • Topline results from JUNIPER Phase 2 placebo-controlled, dose-ranging study of DaxibotulinumtoxinA for Injection in upper limb spasticity expected first quarter 2021.
    • Topline results from the companion ASPEN-OLS Phase 3 open-label, long-term safety trial, expected in 2021.

    2020 Financial Outlook

    Revance expects GAAP (U.S. generally accepted accounting principles, or GAAP) operating expense to be $285 to $295 million and non-GAAP operating expense, which excludes costs of revenue, depreciation and amortization, stock-based compensation, and non-cash in-process research and development costs, to be in the range of $220 to $230 million. With multiple clinical programs underway, along with regulatory and pre-commercial manufacturing activities, Revance anticipates 2020 non-GAAP, non-HintMD related research and development expense to be $95 to $100 million. With current cash and equivalents, management projects that the company is funded into 2023.

    Conference Call

    Individuals interested in listening to the conference call may do so by dialing (855) 453-3827 for domestic callers, or (484) 756-4301 for international callers and reference conference ID: 4467177; or from the webcast link in the investor relations section of the company's website at: www.revance.com. A replay of the call will be available beginning November 9, 2020 at 4:30 p.m. PT/7:30 p.m. ET to November 10, 2020 at 4:30 p.m. PT/7:30 p.m. ET. To access the replay, dial (855) 859-2056 or (404) 537-3406 and reference conference ID: 4467177.

    The live webcast can be accessed here and will be available in the investor relations section on the company's website for 30 days following the completion of the call. In light of reduced call center resources during this time of required social-distancing, Revance requests that listeners who do not plan on participating in the question and answer session listen to the live webcast rather than dialing in by phone.

    About Revance Therapeutics, Inc.

    Revance Therapeutics, Inc. is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection. DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval in 2020. Revance is also evaluating DaxibotulinumtoxinA for Injection in the full upper face, including glabellar lines, forehead lines and crow's feet, as well as in three therapeutic indications - cervical dystonia, plantar fasciitis and adult upper limb spasticity.

    To accompany DaxibotulinumtoxinA for Injection, Revance owns a unique portfolio of premium products and services for U.S. aesthetics practices, including the exclusive U.S. distribution rights to the RHA® Collection of dermal fillers, the first and only range of FDA-approved fillers for correction of dynamic facial wrinkles and folds, and the HintMD fintech platform, which includes integrated smart payment, subscription and loyalty digital services.

    Revance has also partnered with Mylan N.V. to develop a biosimilar to BOTOX®, which would compete in the existing short-acting neuromodulator marketplace. Revance is dedicated to making a difference by transforming patient experiences. For more information or to join our team visit us at www.revance.com.

    "Revance Therapeutics" and the Revance logo are registered trademarks of Revance Therapeutics, Inc.

    RHA resilient hyaluronic acid® and RHA® are trademarks of TEOXANE SA.

    BOTOX® is a registered trademark of Allergan, Inc.

    Forward-Looking Statements

    Any statements in this press release that are not statements of historical fact, including statements related to Revance's financial outlook, milestone expectations, expected cash runway and financial performance; statements about our ability to obtain, and the timing relating to, regulatory approval with respect to our drug product candidates, including with respect to the anticipated approval of DaxibotulinumtoxinA for Injection in glabellar lines and the expected PDUFA date; the rate and degree of commercial acceptance, opportunity and growth potential of Teoxane's RHA® Collection of dermal fillers and the HintMD payments platform, and our product candidates, if approved; the process and timing of, and ability to complete, the current and anticipated future clinical development of our product candidates; the initiation, design, enrollment, submission, timing and results of our clinical studies, including the near-term milestone expectations described above; development of a biosimilar to BOTOX®; statements about our business strategy, timeline and other goals and market for our anticipated products, plans and prospects, including our commercialization plans; and potential benefits of our drug product candidates and our technologies, including the RHA® Collection of dermal fillers and HintMD fintech platform, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance, events, circumstances or achievements reflected in the forward-looking statements will ever be achieved or occur.

    Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties relate, but are not limited to: the results, timing, costs, and completion of our research and development activities and regulatory approvals, including the potential delay in the anticipated PDUFA target action date for DaxibotulinumtoxinA for Injection for the treatment of glabellar lines due to COVID-19-related policies and travel restrictions currently in place at the FDA; the impact of the COVID-19 pandemic on our manufacturing operations, supply chain, end user demand for our products, commercialization efforts, business operations, clinical trials and other aspects of our business; our ability to manufacture supplies for our product candidates and to acquire supplies of the RHA® Collection of dermal fillers; the uncertain clinical development process, including the risk that the top-line results from the ASPEN-1 trial are based on our preliminary analysis of key efficacy and safety data, the fact that such data may change following a more comprehensive review of the data related to the clinical trial and such top-line data may not accurately reflect the complete results of the trial, and the FDA may not agree with our interpretation of such results; the risk that clinical trials may not have an effective design or generate positive results; the applicability of clinical study results to actual outcomes; our ability to obtain regulatory approval of our drug product candidates; whether the HintMD acquisition and Teoxane agreement will provide the anticipated economic and other benefits; the rate and degree of commercial acceptance and the market, size and growth potential of the RHA® Collection of dermal fillers, the HintMD payments platform and our drug product candidates, if approved; our ability to successfully commercialize the RHA® Collection of dermal fillers, the HintMD payments platform and our drug product candidates, if approved, and the timing and cost of commercialization activities; our ability to develop sales and marketing capabilities; the status of commercial collaborations; our ability to obtain funding for our operations; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; and our financial performance, including future revenue, expenses and capital requirements. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in our periodic filings with the Securities and Exchange Commission (SEC), including factors described in the section entitled "Risks Factors" on our Form 10-Q filed with the SEC on August 6, 2020 and in our future filings with the SEC, including, without limitation, our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, expected to be filed with the SEC on November 9, 2020. The forward-looking statements in this press release speak only as of the date hereof. We disclaim any obligation to update these forward-looking statements.

    Use of Non-GAAP Financial Measures

    Revance has presented certain non-GAAP financial measures in this release. This release and the reconciliation tables included herein include total non-GAAP operating expense and non-GAAP R&D expense, both of which exclude costs of revenue, depreciation and amortization, stock-based compensation, and non-cash in-process research and development costs. Revance excludes costs of revenue, depreciation and amortization, stock-based compensation, and non-cash in-process research and development costs because management believes the exclusion of these items is helpful to investors to evaluate Revance's recurring operational performance. Revance management uses these non-GAAP financial measures to monitor and evaluate its operating results and trends on an on-going basis, and internally for operating, budgeting and financial planning purposes. The non-GAAP financial measures should be considered in addition to results prepared in accordance with GAAP but should not be considered a substitute for or superior to GAAP results.

    Certain non-GAAP measures included in this report were not reconciled to the comparable GAAP financial measures because the GAAP measures are not accessible on a forward-looking basis. The company is unable to reconcile these forward-looking non-GAAP financial measures to the most directly comparable GAAP measures without unreasonable efforts because the company is currently unable to predict with a reasonable degree of certainty the type and extent of certain items that would be expected to impact GAAP measures for these periods but would not impact the non-GAAP measures. Such items include costs of revenue, depreciation and amortization, stock-based compensation, and non-cash in-process research and development costs. The unavailable information could have a significant impact on the company's GAAP financial results.

     

    REVANCE THERAPEUTICS, INC.

    Condensed Consolidated Balance Sheets

    (In thousands, except share and per share amounts)

    (Unaudited)

     

     

    September 30,

     

    December 31,

     

    2020

     

     

    2019

     

    ASSETS

    CURRENT ASSETS

     

     

     

    Cash and cash equivalents

    $

    339,439

     

     

     

    $

    171,160

     

     

    Short-term investments

    96,392

     

     

     

    118,955

     

     

    Accounts and other receivable

    2,585

     

     

     

     

     

    Inventories

    3,976

     

     

     

     

     

    Prepaid expenses and other current assets

    7,713

     

     

     

    6,487

     

     

    Total current assets

    450,105

     

     

     

    296,602

     

     

    Property and equipment, net

    14,843

     

     

     

    14,755

     

     

    Goodwill

    144,505

     

     

     

     

     

    Intangible assets, net

    74,849

     

     

     

     

     

    Operating lease right of use assets

    25,446

     

     

     

    26,531

     

     

    Restricted cash

    1,245

     

     

     

    730

     

     

    Other non-current assets

    1,154

     

     

     

    1,669

     

     

    TOTAL ASSETS

    $

    712,147

     

     

     

    $

    340,287

     

     

    LIABILITIES AND STOCKHOLDERS' EQUITY

    CURRENT LIABILITIES

     

     

     

    Accounts payable

    $

    7,860

     

     

     

    $

    8,010

     

     

    Accruals and other current liabilities

    37,659

     

     

     

    18,636

     

     

    Deferred revenue, current portion

    10,931

     

     

     

    7,911

     

     

    Operating lease liabilities, current portion

    4,040

     

     

     

    3,470

     

     

    Derivative liability

    3,163

     

     

     

    2,952

     

     

    Total current liabilities

    63,653

     

     

     

    40,979

     

     

    Convertible senior notes

    177,377

     

     

     

     

     

    Deferred revenue, net of current portion

    74,811

     

     

     

    47,948

     

     

    Operating lease liabilities, net of current portion

    23,453

     

     

     

    25,870

     

     

    TOTAL LIABILITIES

    339,294

     

     

     

    114,797

     

     

    STOCKHOLDERS' EQUITY

     

     

     

    Convertible preferred stock, par value $0.001 per share — 5,000,000 shares authorized, and no shares issued and outstanding as of September 30, 2020 and December 31, 2019

     

     

     

     

     

    Common stock, par value $0.001 per share — 95,000,000 shares authorized both as of September 30, 2020 and December 31, 2019; 66,587,713 and 52,374,735 shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively

    67

     

     

     

    52

     

     

    Additional paid-in capital

    1,420,770

     

     

     

    1,069,639

     

     

    Accumulated other comprehensive income

     

     

     

    3

     

     

    Accumulated deficit

    (1,047,984

    )

     

     

    (844,204

    )

     

    TOTAL STOCKHOLDERS' EQUITY

    372,853

     

     

     

    225,490

     

     

    TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY

    $

    712,147

     

     

     

    $

    340,287

     

     

     

    REVANCE THERAPEUTICS, INC.

    Condensed Consolidated Statements of Operations and Comprehensive Loss

    (In thousands, except share and per share amounts)

    (Unaudited)

     

     

    Three Months Ended September 30,

     

    Nine Months Ended September 30,

     

    2020

     

     

    2019

     

     

    2020

     

     

    2019

     

    Revenue:

     

     

     

     

     

     

     

    Product revenue

    $

    2,819

     

     

     

    $

     

     

     

    $

    2,868

     

     

     

    $

     

     

    Collaboration revenue

    808

     

     

     

    46

     

     

     

    1,116

     

     

     

    324

     

     

    Service revenue

    208

     

     

     

     

     

     

    208

     

     

     

     

     

    Total revenue

    3,835

     

     

     

    46

     

     

     

    4,192

     

     

     

    324

     

     

    Operating expenses:

     

     

     

     

     

     

     

    Cost of product revenue (exclusive of amortization)

    1,081

     

     

     

     

     

     

    1,102

     

     

     

     

     

    Cost of service revenue (exclusive of amortization)

    4

     

     

     

     

     

     

    4

     

     

     

     

     

    Research and development

    29,130

     

     

     

    25,847

     

     

     

    96,027

     

     

     

    75,368

     

     

    Selling, general and administrative

    48,183

     

     

     

    16,739

     

     

     

    99,013

     

     

     

    43,245

     

     

    Amortization

    2,565

     

     

     

     

     

     

    3,239

     

     

     

     

     

    Total operating expenses

    80,963

     

     

     

    42,586

     

     

     

    199,385

     

     

     

    118,613

     

     

    Loss from operations

    (77,128

    )

     

     

    (42,540

    )

     

     

    (195,193

    )

     

     

    (118,289

    )

     

    Interest income

    413

     

     

     

    1,329

     

     

     

    2,868

     

     

     

    4,495

     

     

    Interest expense

    (4,334

    )

     

     

     

     

     

    (10,738

    )

     

     

     

     

    Changes in fair value of derivative liability

    (62

    )

     

     

    (68

    )

     

     

    (211

    )

     

     

    (139

    )

     

    Other expense, net

    (146

    )

     

     

    (130

    )

     

     

    (406

    )

     

     

    (170

    )

     

    Loss before income taxes

    (81,257

    )

     

     

    (41,409

    )

     

     

    (203,680

    )

     

     

    (114,103

    )

     

    Income tax provision

     

     

     

     

     

     

    (100

    )

     

     

     

     

    Net loss

    (81,257

    )

     

     

    (41,409

    )

     

     

    (203,780

    )

     

     

    (114,103

    )

     

    Unrealized gain (loss) and adjustment on securities included in net loss

    (117

    )

     

     

    (74

    )

     

     

    (3

    )

     

     

    50

     

     

    Comprehensive loss

    $

    (81,374

    )

     

     

    $

    (41,483

    )

     

     

    $

    (203,783

    )

     

     

    $

    (114,053

    )

     

    Basic and diluted net loss

    $

    (81,257

    )

     

     

    $

    (41,409

    )

     

     

    $

    (203,780

    )

     

     

    $

    (114,103

    )

     

    Basic and diluted net loss per share

    $

    (1.34

    )

     

     

    $

    (0.96

    )

     

     

    $

    (3.62

    )

     

     

    $

    (2.67

    )

     

    Basic and diluted weighted-average number of shares used in computing net loss per share

    60,526,740

    43,314,831

    56,233,093

    42,730,983

     

     

    REVANCE THERAPEUTICS, INC.

    Reconciliation of GAAP Operating Expense to Non-GAAP Operating Expense

    (In thousands)

    (Unaudited)

     

     

    Three Months Ended

     

    Nine Months Ended

     

    September 30, 2020

     

    September 30, 2020

    Operating expense:

     

     

     

    GAAP operating expense

    $

    80,963

     

     

     

    $

    199,385

     

     

    Adjustments:

     

     

     

    In-process research and development

     

     

     

    (11,184

    )

     

    Stock-based compensation

    (10,677

    )

     

     

    (24,574

    )

     

    Depreciation and amortization

    (3,779

    )

     

     

    (5,931

    )

     

    Costs of revenue (exclusive of amortization)

    (1,085

    )

     

     

    (1,106

    )

     

    Non-GAAP operating expense

    $

    65,422

     

     

     

    $

    156,590

     

     

     

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  21. - Patients reported significant pain reduction that was numerically greater than placebo, however, the primary efficacy endpoint was not met –

    Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced results from its Phase 2 clinical trial of investigational drug candidate DaxibotulinumtoxinA for Injection for the management of plantar fasciitis, a painful affliction caused by inflammation of the ligament running along the bottom of the foot (the plantar fascia), the most common cause of heel pain.1

    This Phase 2 prospective, randomized, double-blind, multi-center, placebo-controlled trial evaluated the safety and efficacy of two doses of DaxibotulinumtoxinA…

    - Patients reported significant pain reduction that was numerically greater than placebo, however, the primary efficacy endpoint was not met –

    Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced results from its Phase 2 clinical trial of investigational drug candidate DaxibotulinumtoxinA for Injection for the management of plantar fasciitis, a painful affliction caused by inflammation of the ligament running along the bottom of the foot (the plantar fascia), the most common cause of heel pain.1

    This Phase 2 prospective, randomized, double-blind, multi-center, placebo-controlled trial evaluated the safety and efficacy of two doses of DaxibotulinumtoxinA for Injection in reducing the signs and symptoms of plantar fasciitis. The trial enrolled 155 adult patients with unilateral plantar fasciitis, 18 to 65 years of age, at 17 study centers in the United States. Patients were randomized (1:1:1) to receive an injection of DAXI 80 U, DAXI 120 U or placebo. The study's primary efficacy endpoint was the change from baseline on the 10-point Numeric Pain Rating Scale (NPRS) score averaged over five days at Week 8. Patients were followed for up to 24 weeks post treatment to assess treatment response, tolerability and safety.

    In the trial, both doses of DaxibotulinumtoxinA for Injection resulted in significant, measurable pain relief after treatment that was numerically greater than placebo. However, neither dose met the primary efficacy endpoint of statistically significant improvement from baseline in the NPRS for foot pain at Week 8, compared to placebo. Subjects treated with DaxibotulinumtoxinA for Injection showed an average reduction from baseline of 3.29 on the NPRS (a 54.6% reduction) at 80U (p=0.2135 vs. placebo) and 3.25 on the NPRS (a 50.1% reduction) at 120U (p=0.2205 vs. placebo, p=0.9207 vs. 80U), compared to placebo subjects at 2.75 on the NPRS (a 45.1% reduction).

    DaxibotulinumtoxinA for Injection was found to be safe and well-tolerated at both doses through Week 24. There were no serious treatment-related adverse events and no dose dependent increase in adverse events was observed. Treatment-related adverse events were generally transient and mild to moderate in severity. The two most common treatment-related adverse events were (for 80 Units, 120 Units and placebo, respectively) injection site pain (6.1%, 5.6%, 5.8%) and injection site erythema (2.0%, 1.9%, 1.9%).

    "While we are disappointed with these Phase 2 results, it's important to note that no other neuromodulator has been approved for the treatment of plantar fasciitis, which is a new therapeutic category with an underlying physiology that is different from currently approved indications for muscle movement and pain disorders that utilize neuromodulators," said Mark Foley, President and Chief Executive Officer of Revance. "Though we plan to further analyze the plantar fasciitis data, we will primarily focus our therapeutic efforts on established neuromodulator indications, including muscle movement disorders where our positive ASPEN-1 Phase 3 cervical dystonia results are a source of confidence. Consequently, we look forward to announcing the topline results from our JUNIPER Phase 2 upper limb spasticity trial in the first quarter of 2021."

    About Revance Therapeutics, Inc.

    Revance Therapeutics, Inc. is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection. DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval in 2020. Revance is also evaluating DaxibotulinumtoxinA for Injection in the full upper face, including glabellar lines, forehead lines and crow's feet, as well as in three therapeutic indications - cervical dystonia, adult upper limb spasticity and plantar fasciitis. To accompany DaxibotulinumtoxinA for Injection, Revance has built a unique portfolio of premium products and services for U.S. aesthetics practices, including the RHA® Collection of dermal fillers in the U.S., the first and only range of FDA-approved fillers for correction of dynamic facial wrinkles and folds, and the HintMD fintech platform, which includes integrated smart payment, subscription and loyalty digital services. Revance has also partnered with Mylan N.V. to develop a biosimilar to BOTOX®, which would compete in the existing short-acting neuromodulator marketplace. Revance is dedicated to making a difference by transforming patient experiences. For more information or to join our team visit us at www.revance.com.

    "Revance Therapeutics" and the Revance logo are registered trademarks of Revance Therapeutics, Inc.

    Resilient Hyaluronic Acid® and RHA® are trademarks of TEOXANE SA.

    BOTOX® is a registered trademark of Allergan, Inc.

    Forward-Looking Statements

    Any statements in this press release that are not statements of historical fact, including statements about our analysis of the plantar fasciitis data; the therapeutic and commercial potential of DaxibotulinumtoxinA for Injection; the potential value of DaxibotulinumtoxinA for Injection in established neuromodulator indications, including muscle movement disorders; the process and timing of, and ability to complete, of current and anticipated future clinical development of our investigational drug product candidates; our ability to obtain, and the timing relating to, regulatory approval with respect to our drug product candidates, including with respect to the anticipated approval of DaxibotulinumtoxinA for Injection in glabellar lines and the expected Prescription Drug User Fee Act (PDUFA) action date of November 25, 2020; the initiation, design, enrollment, submission, timing and results of our clinical studies, including the near-term milestone expectations described above; development of a biosimilar to BOTOX®; our business strategy, timeline and other goals for our anticipated products, plans and prospects, including our commercialization plans; and potential benefits of our drug product candidates, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance, events, circumstances or achievements reflected in the forward-looking statements will ever be achieved or occur.

    Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties relate to, but are not limited to: the results, timing, costs, and completion of our research and development activities; the uncertain clinical development process, including the risk that the top-line results from the ASPEN-1 trial evaluating DaxibotulinumtoxinA for Injection for the treatment of cervical dystonia are based on our preliminary analysis of key efficacy and safety data, the fact that such data may change following a more comprehensive review of the data related to the clinical trial and such top-line data may not accurately reflect the complete results of the trial, and the FDA may not agree with our interpretation of such results; clinical trials may not have an effective design or generate positive results; our plans to research, develop, and commercialize our drug product candidates; the applicability of clinical study results to actual outcomes; our ability to obtain regulatory approval of our drug product candidates, including with respect to a potential delay in the anticipated PDUFA target action date for DaxibotulinumtoxinA for Injection for the treatment of glabellar lines due to COVID-19-related policies and travel restrictions currently in place at the FDA; our ability to successfully commercialize our drug product candidates, if approved, and the timing and cost of commercialization activities; our ability to obtain funding for our operations; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; our financial performance, including future revenue, expenses and capital requirements; and the impact of the COVID-19 pandemic on our manufacturing operations, supply chain, business operations, clinical trials and other aspects of our business. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in our periodic filings with the Securities and Exchange Commission (SEC), including factors described in the section entitled "Risks Factors" on our Form 10-Q filed with the SEC on August 6, 2020 and in our future filings with the SEC, including, without limitation, our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, expected to be filed with the SEC on November 9, 2020. The forward-looking statements in this press release speak only as of the date hereof. We disclaim any obligation to update these forward-looking statements.

    References:

    1. Med Clin N America. 2014;98(2): 339-352.

    Source: Revance Therapeutics, Inc.

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  22. Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its investigational neuromodulator product, DaxibotulinumtoxinA for Injection, today announced that the company will participate in the Credit Suisse 29th Annual Healthcare Conference, a fully virtual management access conference, taking place November 9-12.

    Chief Financial Officer, Toby Schilke, is scheduled to present on Tuesday, November 10, at 7:15 a.m. PT / 10:15 a.m. ET.

    Interested parties can access the live audio webcast for this conference from the Investor Relations section of the company's website at www.revance.com. The webcast replay will be available after the conclusion of the live presentation…

    Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its investigational neuromodulator product, DaxibotulinumtoxinA for Injection, today announced that the company will participate in the Credit Suisse 29th Annual Healthcare Conference, a fully virtual management access conference, taking place November 9-12.

    Chief Financial Officer, Toby Schilke, is scheduled to present on Tuesday, November 10, at 7:15 a.m. PT / 10:15 a.m. ET.

    Interested parties can access the live audio webcast for this conference from the Investor Relations section of the company's website at www.revance.com. The webcast replay will be available after the conclusion of the live presentation for approximately 30 days.

    About Revance Therapeutics, Inc.

    Revance Therapeutics, Inc. is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection. DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval in 2020. Revance is also evaluating DaxibotulinumtoxinA for Injection in the full upper face, including glabellar lines, forehead lines and crow's feet, as well as in three therapeutic indications - cervical dystonia, adult upper limb spasticity and plantar fasciitis. To accompany DaxibotulinumtoxinA for Injection, Revance owns a unique portfolio of premium products and services for U.S. aesthetics practices, including the exclusive U.S. distribution rights to the RHA® Collection of dermal fillers, the first and only range of FDA-approved fillers for correction of dynamic facial wrinkles and folds, and the HintMD fintech platform, which includes integrated smart payment, subscription and loyalty digital services. Revance has also partnered with Mylan N.V. to develop a biosimilar to BOTOX®, which would compete in the existing short-acting neuromodulator marketplace. Revance is dedicated to making a difference by transforming patient experiences. For more information or to join our team visit us at www.revance.com.

    "Revance Therapeutics" and the Revance logo are registered trademarks of Revance Therapeutics, Inc.

    RHA resilient hyaluronic acid® and RHA® are trademarks of TEOXANE SA.

    BOTOX® is a registered trademark of Allergan, Inc.

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  23. Conference Call Scheduled for Monday, November 9, 2020 at 4:30 p.m. ET

    Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its investigational neuromodulator product, DaxibotulinumtoxinA for Injection, today announced that the company will release third quarter 2020 financial results on Monday, November 9, 2020 after the close of market. Revance will host a corresponding conference call and a live webcast at 1:30 p.m. PT/4:30 p.m. ET on the same day to discuss the results and provide a business and pipeline update.

    Individuals interested in listening to the conference call may do so by dialing (855) 453-3827 for domestic callers, or (484) 756-4301 for international…

    Conference Call Scheduled for Monday, November 9, 2020 at 4:30 p.m. ET

    Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its investigational neuromodulator product, DaxibotulinumtoxinA for Injection, today announced that the company will release third quarter 2020 financial results on Monday, November 9, 2020 after the close of market. Revance will host a corresponding conference call and a live webcast at 1:30 p.m. PT/4:30 p.m. ET on the same day to discuss the results and provide a business and pipeline update.

    Individuals interested in listening to the conference call may do so by dialing (855) 453-3827 for domestic callers, or (484) 756-4301 for international callers and reference conference ID: 4467177; or from the webcast link in the investor relations section of the company's website at: www.revance.com.

    A replay of the call will be available beginning November 9, 2020 at 4:30 p.m. PT/7:30 p.m. ET to November 10, 2020 at 4:30 p.m. PT/7:30 p.m. ET. To access the replay, dial (855) 859-2056 or (404) 537-3406 and reference conference ID: 4467177. The live webcast can be accessed here and will be available in the investor relations section on the company's website for 30 days following the completion of the call.

    In light of reduced call center resources during this time of required social-distancing, Revance requests listeners not planning on participating in Q&A to listen to the live webcast rather than dialing in by phone.

    About Revance Therapeutics, Inc.

    Revance Therapeutics, Inc. is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection. DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval in 2020. Revance is also evaluating DaxibotulinumtoxinA for Injection in the full upper face, including glabellar lines, forehead lines and crow's feet, as well as in three therapeutic indications - cervical dystonia, adult upper limb spasticity and plantar fasciitis. To accompany DaxibotulinumtoxinA for Injection, Revance owns a unique portfolio of premium products and services for U.S. aesthetics practices, including the exclusive U.S. distribution rights to the RHA® Collection of dermal fillers, the first and only range of FDA-approved fillers for correction of dynamic facial wrinkles and folds, and the HintMD fintech platform, which includes integrated smart payment, subscription and loyalty digital services. Revance has also partnered with Mylan N.V. to develop a biosimilar to BOTOX®, which would compete in the existing short-acting neuromodulator marketplace. Revance is dedicated to making a difference by transforming patient experiences. For more information or to join our team visit us at www.revance.com.

    "Revance Therapeutics" and the Revance logo are registered trademarks of Revance Therapeutics, Inc.

    RHA resilient hyaluronic acid® and RHA® are trademarks of TEOXANE SA.

    BOTOX® is a registered trademark of Allergan, Inc.

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  24. Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its investigational neuromodulator product, DaxibotulinumtoxinA for Injection, today announced new hire grants totaling an aggregate of 58,800 inducement restricted stock awards ("RSAs") to eleven employees. The RSAs vest over four years, with 25% of the underlying shares vesting on each of the four anniversaries of the applicable vesting commencement date, subject to the new employee's continued service relationship with Revance through the applicable vesting dates.

    The Compensation Committee of Revance's Board of Directors approved the awards as an inducement material to the new employees' employment in accordance…

    Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its investigational neuromodulator product, DaxibotulinumtoxinA for Injection, today announced new hire grants totaling an aggregate of 58,800 inducement restricted stock awards ("RSAs") to eleven employees. The RSAs vest over four years, with 25% of the underlying shares vesting on each of the four anniversaries of the applicable vesting commencement date, subject to the new employee's continued service relationship with Revance through the applicable vesting dates.

    The Compensation Committee of Revance's Board of Directors approved the awards as an inducement material to the new employees' employment in accordance with NASDAQ Listing Rule 5635(c)(4).

    About Revance Therapeutics, Inc.

    Revance Therapeutics, Inc. is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection. DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval in 2020. Revance is also evaluating DaxibotulinumtoxinA for Injection in the full upper face, including glabellar lines, forehead lines and crow's feet, as well as in three therapeutic indications - cervical dystonia, adult upper limb spasticity and plantar fasciitis. To accompany DaxibotulinumtoxinA for Injection, Revance owns a unique portfolio of premium products and services for U.S. aesthetics practices, including the exclusive U.S. distribution rights to the RHA® Collection of dermal fillers, the first and only range of FDA-approved fillers for correction of dynamic facial wrinkles and folds, and the HintMD fintech platform, which includes integrated smart payment, subscription and loyalty digital services. Revance has also partnered with Mylan N.V. to develop a biosimilar to BOTOX®, which would compete in the existing short-acting neuromodulator marketplace. Revance is dedicated to making a difference by transforming patient experiences. For more information or to join our team visit us at www.revance.com.

    "Revance Therapeutics" and the Revance logo are registered trademarks of Revance Therapeutics, Inc.

    RHA resilient hyaluronic acid® and RHA® are trademarks of TEOXANE SA.

    BOTOX® is a registered trademark of Allergan, Inc.

    Source: Revance Therapeutics, Inc.

    View Full Article Hide Full Article
  25. - Trial met primary and all secondary endpoints for both 125- and 250-Unit doses with high statistical significance -

    - DaxibotulinumtoxinA for Injection was effective and generally well-tolerated in reducing the signs and symptoms for cervical dystonia, delivering up to a median duration of 24 weeks -

    - Results suggest DaxibotulinumtoxinA for Injection has the potential to reduce frequency of cervical dystonia treatments by up to 50% annually -

    - Global market opportunity for cervical dystonia is $340M1 -

    - Conference call today at 8:30 a.m. ET -

    Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced positive topline results from its ASPEN-1 Phase 3…

    - Trial met primary and all secondary endpoints for both 125- and 250-Unit doses with high statistical significance -

    - DaxibotulinumtoxinA for Injection was effective and generally well-tolerated in reducing the signs and symptoms for cervical dystonia, delivering up to a median duration of 24 weeks -

    - Results suggest DaxibotulinumtoxinA for Injection has the potential to reduce frequency of cervical dystonia treatments by up to 50% annually -

    - Global market opportunity for cervical dystonia is $340M1 -

    - Conference call today at 8:30 a.m. ET -

    Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced positive topline results from its ASPEN-1 Phase 3 randomized, double-blind, placebo-controlled, parallel group clinical trial for its investigational drug candidate DaxibotulinumtoxinA for Injection for the treatment of cervical dystonia, a chronic and debilitating neurologic condition affecting the muscles of the neck.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201014005360/en/

    This pivotal study enrolled a total of 301 subjects at 60 sites in the U.S., Canada and Europe. Subjects were randomized 3:3:1 to receive a single treatment of either 125 Units or 250 Units of DaxibotulinumtoxinA for Injection, or placebo and were followed for up to 36 weeks. The drug was generally safe and well-tolerated at both doses, with an encouraging safety profile.

    The study met its primary efficacy endpoint at both doses, demonstrating a clinically meaningful improvement in the signs and symptoms of cervical dystonia at the average of Weeks 4 and 6. Compared to placebo, subjects treated with either 125 Units or 250 Units showed a statistically significant greater change from baseline (12.7 and 10.9 respectively vs. 4.3, p<0.0001 and p=0.0006) as measured on the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score.

    Median duration of effect was 24.0 and 20.3 weeks, for the 125 Unit and 250 Unit dose groups respectively, based on the median time to loss of 80% of the peak treatment effect.

    "I was delighted to see both the degree and duration of relief that DaxibotulinumtoxinA for Injection provided trial subjects in ASPEN-1. Currently, most patients with cervical dystonia visit their physician 3 to 4 times a year for injections, which places a heavy burden on patients' time and schedule. Often, the treatment effect wears off between injections, significantly impacting the quality of their work and personal lives," said trial investigator Dr. Joseph Jankovic, Professor of Neurology, Distinguished Chair in Movement Disorders, Founder and Director, The Parkinson's Disease Center and Movement Disorders Clinic at Baylor College of Medicine, Houston, Texas. "If a treatment could offer longer duration of effect, thus requiring fewer trips each year for reinjection, I imagine patients would find this quite beneficial."

    "We are very pleased to report these positive results from the ASPEN-1 Phase 3 trial, as this is the company's second successful Phase 3 program demonstrating DaxibotulinumtoxinA for Injection's extended duration profile, now across two different treatment categories – aesthetics and therapeutics. In addition to laying the foundation for our therapeutics franchise, these results reinforce its potential in other muscle movement and pain disorders," said Mark Foley, President and Chief Executive Officer at Revance. "A cervical dystonia treatment option with a longer duration of effect has the ability to offer patients a meaningful extension of symptom relief while also providing a compelling pharmacoeconomic profile. We look forward to continuing to leverage the differentiated performance profile of DaxibotulinumtoxinA for Injection across the $5.1B global neuromodulator market."

    The company expects results from the companion ASPEN-OLS Phase 3 open-label, long-term safety trial, which enrolled 354 subjects, in 2021.

    EFFICACY RESULTS:

    Positive efficacy results were seen with both DaxibotulinumtoxinA for Injection dose groups studied. The trial's primary efficacy measurements were based on the average of the change from baseline in TWSTRS Total Score at Weeks 4 and 6. TWSTRS Total Score is a composite score evaluating features of the cervical dystonia condition, including severity, disability and pain:

    125 Unit Dose

     

    250 Unit Dose

     

    Placebo

    Average Reduction from Baseline

    in TWSTRS Total Score

    12.7 (31%, p<0.0001)

     

    10.9 (27%, p=0.0006)

     

    4.3 (12%)

    (% change from baseline, p-value vs. placebo)

     

    The median duration of effect was 24.0 weeks for the 125 Unit dose, and 20.3 weeks for the 250 Unit dose, as measured by the time to loss of 80% of the peak treatment effect.

    Two of the secondary endpoints measured the percentage of responders showing improvement with at least a 2-point improvement based on the Clinical Global Impression of Change (CGIC) and Patient Global Impression of Change (PGIC) at Week 4 or 6. Both the clinician and patient results were consistent and showed a statistically significant improvement greater than placebo (p<0.001).

    SAFETY RESULTS: In both dose groups, DaxibotulinumtoxinA for Injection appeared to be generally safe and well-tolerated through Week 36. There were no serious treatment-related adverse events and no dose-dependent increase in adverse events was observed. Treatment-related adverse events were generally transient and mild to moderate in severity, with one case of neck pain reported as severe, which resolved two days after onset. The three most common treatment-related adverse events were (for 125 Units and 250 Units):

    • Injection site pain (7.9%, 4.7%)
    • Headache (4.7%, 4.7%)
    • Injection site erythema (4.7%, 2.3%)

    The incidence of dysphagia (difficulty swallowing) and muscle weakness, which are considered adverse events of particular interest with botulinum toxin treatments for cervical dystonia, was encouragingly low: dysphagia (1.6%, 3.9%) and muscular weakness (4.7%, 2.3%).

    ASPEN Phase 3 Clinical Program in Cervical Dystonia

    In 2017, the U.S. Food and Drug Administration (FDA) granted orphan drug designation for DaxibotulinumtoxinA for Injection to treat cervical dystonia, which provides certain developmental and financial benefits to trial sponsors.

    The company's ASPEN Phase 3 clinical program consists of two trials to evaluate the safety and efficacy of DaxibotulinumtoxinA for Injection for the treatment of cervical dystonia in adults: 1) ASPEN-1, a randomized, double-blind, placebo-controlled, parallel group trial and; 2) ASPEN-OLS, an open-label, long-term safety trial.

    Randomized Trial (ASPEN-1): Patients were randomized to a single treatment of either 125 Unit or 250 Unit dose of DaxibotulinumtoxinA for Injection, or placebo. Post-treatment, patients are followed for a maximum of 36 weeks. The primary efficacy endpoint of the trial was the mean change from baseline in the TWSTRS Total Score at the average of Week 4 and 6. Key secondary endpoints include the duration of treatment effect, measurement of treatment response on the Clinical and Patient Global Impression of Change assessments, and adverse events. Further, the trial featured exploratory efficacy assessments including the Cervical Dystonia Impact Profile (CDIP-58), a disease-specific, patient-rated questionnaire that measures quality of life.

    Open-Label Study (ASPEN-OLS): Patients receive up to four sequential treatment cycles of DaxibotulinumtoxinA for Injection over the 52-week observation period. Primary endpoints of the trial are safety and immunogenicity after multiple cycles of treatment with DaxibotulinumtoxinA for Injection. Key secondary endpoints are the change from baseline in TWSTRS Total Score, and the duration of treatment effect, as well as overall treatment response based on the Clinical and Patient Global Impression of Change. The ASPEN-OLS trial enrollment is fully enrolled with a total of 354 patients at sites located in the United States, Canada, and Europe.

    Additional information about the ASPEN Phase 3 program is available at www.clinicaltrials.gov.

    About Cervical Dystonia

    According to the Dystonia Medical Research Foundation, cervical dystonia is a painful condition in which the neck muscles contract involuntarily, causing abnormal movements and awkward posture of the head and neck. The movements may be sustained (tonic), jerky (clonic), or a combination. Cervical dystonia (also referred to as spasmodic torticollis) may be primary (meaning that it is the only apparent neurological disorder, with or without a family history) or may be the result of secondary causes (such as physical trauma).

    First-line treatment for cervical dystonia is usually neuromodulator (botulinum toxin) injections, but additional treatments can include oral medications, surgery, and complementary therapies. Neuromodulators block the communication between the nerve and the muscle, relaxing the muscle, which alleviates abnormal involuntary movements and postures. Current neuromodulator treatments for cervical dystonia have a duration of effect of approximately three months. Cervical dystonia can occur at any age, although most individuals first experience symptoms in middle age. The condition affects a few hundred thousand adults and children in the United States alone. The global market opportunity for cervical dystonia is $340 million1. Global Industry Analysts, Inc. estimates the global market for treating muscle movement disorders with botulinum toxins, including cervical dystonia, was approximately $1.1 billion in 2018.

    Conference Call

    The company plans to host a conference call to discuss the results today at 8:30 am ET. A PDF of a slide deck covering the trial design and results will be posted to the company website at 8:05 am ET to accompany the commentary on the conference call. They can be found on the Revance website at www.revance.com within Presentations and Corporate Materials under the Events & Webcast tab. We encourage you to download the PDF prior to the call.

    Individuals interested in listening to the conference call may do so by dialing 1(855)453-3827 for domestic callers, or (484) 756-4301 for international callers and reference conference ID: 1987683; or from the webcast link in the investor relations section of the company's website at: www.revance.com. A replay of the call will be available beginning October 14, 2020 at 8:30 a.m. PT/12:30 a.m. ET to October 16, 2020 at 8:30 a.m. PT/12:30 a.m. ET. To access the replay, dial (855) 859-2056 or (404) 537-3406 and reference conference ID: 1987683.

    The live webcast can be accessed here and will be available in the investor relations section on the company's website for 30 days following the completion of the call. In light of reduced call center resources during this time of required social-distancing, Revance requests that listeners who do not plan on participating in the question and answer session listen to the live webcast rather than dialing in by phone.

    About Revance Therapeutics, Inc.

    Revance Therapeutics, Inc. is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection. DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval in 2020. Revance is also evaluating DaxibotulinumtoxinA for Injection in the full upper face, including glabellar lines, forehead lines and crow's feet, as well as in three therapeutic indications - cervical dystonia, adult upper limb spasticity and plantar fasciitis. To accompany DaxibotulinumtoxinA for Injection, Revance owns a unique portfolio of premium products and services for U.S. aesthetics practices, including the exclusive U.S. distribution rights to the RHA® Collection of dermal fillers, the first and only range of FDA-approved fillers for correction of dynamic facial wrinkles and folds, and the HintMD fintech platform, which includes integrated smart payment, subscription and loyalty digital services. Revance has also partnered with Mylan N.V. to develop a biosimilar to BOTOX®, which would compete in the existing short-acting neuromodulator marketplace. Revance is dedicated to making a difference by transforming patient experiences. For more information or to join our team visit us at www.revance.com.

    "Revance Therapeutics" and the Revance logo are registered trademarks of Revance Therapeutics, Inc.

    Resilient Hyaluronic Acid® and RHA® are trademarks of TEOXANE SA.

    BOTOX® is a registered trademark of Allergan, Inc.

    Forward-Looking Statements

    Any statements in this press release that are not statements of historical fact, including statements about DaxibotulinumtoxinA potential for the treatment of cervical dystonia; its therapeutic and commercial potential; the timing and results of the ASPEN Phase 3 clinical program; potential value for DaxibotulinumtoxinA in other muscle movement and pain disorders; the process and timing of, and ability to complete, current and anticipated future clinical development of our investigational drug product candidates; the initiation, design, enrollment, submission, timing and results of our clinical studies, including the near-term milestone expectations described above; development of a biosimilar to BOTOX®; statements about our business strategy, timeline and other goals and market for our anticipated products, plans and prospects, including our commercialization plans; statements about our ability to obtain, and the timing relating to, regulatory approval with respect to our drug product candidates, including with respect to the anticipated approval of DaxibotulinumtoxinA for Injection in glabellar lines and expected PDUFA date; and potential benefits of our drug product candidates and our technologies, including with respect to the RHA® line of dermal fillers and HintMD fintech platform, constitute forward-looking statements.

    Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties include, but are not limited to: the outcome, cost, and timing of our product development activities and clinical trials; the uncertain clinical development process, including the risk that the top-line results from the ASPEN-1 trial are based on our preliminary analysis of key efficacy and safety data, the fact that such data may change following a more comprehensive review of the data related to the clinical trial and such top-line data may not accurately reflect the complete results of the trial, and the FDA may not agree with our interpretation of such results; clinical trials may not have an effective design or generate positive results; our ability to obtain and maintain regulatory approval of our drug product candidates, including our ability to receive timely approval of DaxibotulinumtoxinA for Injection; our ability to obtain funding for our operations; our plans to research, develop, and commercialize our drug product candidates; unanticipated costs or delays in research, development, and commercialization efforts; our reliance on third-party manufacturers; the applicability of clinical study results to actual outcomes; the size and growth potential of the markets for our drug product candidates; the proper training and administration of our products by physicians and medical staff; our ability to successfully commercialize our drug product candidates and the timing of commercialization activities and anticipated product launches; the rate and degree of market acceptance of our drug product candidates; our ability to develop sales and marketing capabilities; the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for financing; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; and the impact of the COVID-19 pandemic on our manufacturing operations, supply chain, business operations, commercialization efforts, end user demand for our products, clinical trials and other aspects of our business. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in our periodic filings with the Securities and Exchange Commission (the "SEC"), including factors described in the section entitled "Risks Factors" on our Form 10-Q filed with the SEC on August 6, 2020. The forward-looking statements in this press release speak only as of the date hereof. We disclaim any obligation to update these forward-looking statements.

    1.

    SOURCE: Global Industry Analytics Inc. Botulinum Toxin Global Market Trajectory & Analytics; September 2020

     

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  26. - Two oral presentations highlighting new data on DaxibotulinumtoxinA for Injection from the SAKURA Phase 3 program, the largest aesthetic neuromodulator clinical program ever conducted for the treatment of glabellar (frown) lines –

    - One oral presentation featuring new interim analysis data from a Phase 2a open-label study on the safety and efficacy of DaxibotulinumtoxinA for Injection for the treatment of lateral canthal lines (crow's feet) –

    - In addition, there will be two ePosters evaluating the properties of hyaluronic acid-based dermal fillers –

    - Revance to also host ‘Innovative Technology for the Emerging Demand of Facial Dynamics' virtual symposium at ASDS on Saturday, October 10, at 2:30 p.m. ET with Drs. Shannon Humphrey, Arthur

    - Two oral presentations highlighting new data on DaxibotulinumtoxinA for Injection from the SAKURA Phase 3 program, the largest aesthetic neuromodulator clinical program ever conducted for the treatment of glabellar (frown) lines –

    - One oral presentation featuring new interim analysis data from a Phase 2a open-label study on the safety and efficacy of DaxibotulinumtoxinA for Injection for the treatment of lateral canthal lines (crow's feet) –

    - In addition, there will be two ePosters evaluating the properties of hyaluronic acid-based dermal fillers –

    - Revance to also host ‘Innovative Technology for the Emerging Demand of Facial Dynamics' virtual symposium at ASDS on Saturday, October 10, at 2:30 p.m. ET with Drs. Shannon Humphrey, Arthur Swift, Benji Dhillon and Charles Boyd -

    Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its investigational neuromodulator product, DaxibotulinumtoxinA for Injection, today announced three oral presentations and two ePosters at the American Society for Dermatologic Surgery (ASDS) Virtual Annual Meeting, October 9-11, 2020. Presented data will showcase novel findings from the SAKURA Phase 3 program evaluating DaxibotulinumtoxinA for Injection for the treatment of moderate or severe glabellar (frown) lines, as well as a 4-week interim analysis from the Phase 2a open-label study for the treatment of moderate to severe lateral canthal lines (LCL), commonly known as crow's feet lines.

    "These data underscore the potential of DaxibotulinumtoxinA for Injection to set a new standard in facial aesthetics treatments and advance our mission of transforming the patient experience," said Roman Rubio, Senior Vice President of Clinical Development at Revance. "The data from the LCL study were used to optimize our Phase 2 open-label upper facial lines study, which we expect to report results from in the fourth quarter of 2020. Additionally, these findings support our overarching scientific platform as we continue to establish a new category of long-lasting neuromodulator products for our prestige aesthetics portfolio."

    The first presentation will report on the efficacy, duration, and safety of DaxibotulinumtoxinA for Injection in females across multiple age cohorts following the treatment of glabellar lines in the SAKURA program. This subgroup analysis demonstrated that the efficacy and duration of DaxibotulinumtoxinA for Injection for the treatment of glabellar lines is similarly high in adult females independent of age. The second presentation will highlight details from the SAKURA program in which DaxibotulinumtoxinA for Injection treated subjects showed substantial and progressive improvement in the severity of glabellar lines at rest following repeated treatment.

    The final presentation will cover 4-week interim data from the Phase 2a open-label study in crow's feet. Data demonstrated that following treatment of LCLs with DaxibotulinumtoxinA for Injection, 88% of subjects achieved a score of none or mild at Week 4 in at least one treatment group. DaxibotulinumtoxinA for Injection appeared to be well tolerated at all dose levels. These results were previously announced by Revance in June 2020.

    Oral Presentations:

    • DaxibotulinumtoxinA for Injection Demonstrates Consistent Efficacy, Duration, and Safety in Females Independent of Age: Subgroup Analysis from a Large, Phase 3 Program

      Friday, October 9, 2020, 9:36 a.m. – 9:39 a.m. ET during the Session #1: Oral Abstracts.

      Presenter: Glynis Ablon, M.D., FAAD, Dermatologist at Ablon Skin Institute and Research Center, Manhattan Beach, CA, and Associate Clinical Professor at University of California, Los Angeles, CA, USA
    • DaxibotulinumtoxinA for Injection–treated subjects show progressive improvement in static glabellar lines with repeated treatment

      Friday, October 9, 2020, 9:42 a.m. – 9:45 a.m. ET during the Session #1: Oral Abstracts.

      Presenter: Richard Glogau, M.D., Dermatologist at Glogau Dermatology, San Francisco, CA, and Clinical Professor of Dermatology University of California, San Francisco, CA, USA
    • DaxibotulinumtoxinA for Injection for Lateral Canthal Lines: A 4-week Interim Analysis

      Friday, October 9, 2020, 9:39 a.m. – 9:42 a.m. ET during the Session #1: Oral Abstracts.

      Presenter: Terrence Keaney, M.D., FAAD, Dermatologist at SkinDC Cosmetic Center, Arlington, VA, Assistant Clinical Faculty of Dermatology at George Washington University and Howard University, and Director of the Laser and Lipoatrophy Clinic at the Veterans Affairs Hospital, Washington, D.C.

    ePosters:

    • Rheological Evaluation of the Dynamic Properties of Hyaluronic Acid-based Dermal Fillers

      Authors: Vince Bertucci*, Conor Gallagher, Jimmy Faivre, Kevin Legent, Mélanie Gallet, Elodie Tremblais, François Bourdon

      Affiliations: *University of Toronto, Toronto, Ontario, Canada and private practice, Woodbridge, Ontario, Canada; Revance Therapeutics, Inc., Newark, California; Teoxane, Geneva, Switzerland
    • Evaluation of the Impact of Hyaluronic Acid (HA) Filler Manufacturing Technologies on HA Chain Degradation

      Authors: Jay Mashburn, Jimmy Faivre, François Bourdon

      Affiliations: Revance Therapeutics, Inc., Newark, California;Teoxane, Geneva, Switzerland

    Revance is anticipating the U.S. Food and Drug Administration (FDA) approval of DaxibotulinumtoxinA for Injection in glabellar (frown) lines in the fourth quarter of this year and is generating additional data in facial aesthetics, including three Phase 2 open-label trials in lateral canthal (crow's feet), upper facial lines and forehead lines. The open-label Phase 2 trial of DaxibotulinumtoxinA for Injection for the treatment of upper facial lines – glabellar (frown), lateral canthal (crow's feet), and forehead lines combined – completed enrollment in February 2020, and the company expects to report topline results in the fourth quarter of 2020.

    Complete abstracts, details on presentation times and changes to presentation dates can be found on the ASDS website. The above listed dates are subject to change. Please check www.asds.net for the latest information.

    About Revance Therapeutics, Inc.

    Revance Therapeutics, Inc. is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection. DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval in 2020. Revance is also evaluating DaxibotulinumtoxinA for Injection in the full upper face, including glabellar lines, forehead lines and crow's feet, as well as in three therapeutic indications - cervical dystonia, adult upper limb spasticity and plantar fasciitis. To accompany DaxibotulinumtoxinA for Injection, Revance owns a unique portfolio of premium products and services for U.S. aesthetics practices, including the exclusive U.S. distribution rights to the RHA® Collection of dermal fillers, the first and only range of FDA-approved fillers for correction of dynamic facial wrinkles and folds, and the HintMD fintech platform, which includes integrated smart payment, subscription and loyalty digital services. Revance has also partnered with Mylan N.V. to develop a biosimilar to BOTOX®, which would compete in the existing short-acting neuromodulator marketplace. Revance is dedicated to making a difference by transforming patient experiences. For more information or to join our team, visit us at www.revance.com.

    "Revance Therapeutics" and the Revance logo are registered trademarks of Revance Therapeutics, Inc.

    RHA resilient hyaluronic acid® and RHA® are trademarks of TEOXANE SA.

    BOTOX® is a registered trademark of Allergan, Inc.

    Forward-Looking Statement

    This press release contains forward-looking statements, including statements related to Revance's financial outlook, milestone expectations, expected cash runway and financial performance; the planned commercial launch of our RHA® Collection of dermal fillers and the HintMD fintech platform, the process and timing of, and ability to complete, current and anticipated future clinical development of our investigational drug product candidates; the initiation, design, enrollment, submission, timing and results of our clinical studies, including the near-term milestone expectations described above; development of a biosimilar to BOTOX®; results of our non-clinical programs; statements about our business strategy, timeline and other goals and market for our anticipated products, plans and prospects, including our commercialization plans; statements about our ability to obtain, and the timing relating to, regulatory approval with respect to our drug product candidates, including with respect to the anticipated approval of DaxibotulinumtoxinA for Injection in glabellar lines and expected PDUFA date; and potential benefits of our drug product candidates and our technologies, including with respect to the RHA® line of dermal fillers and HintMD fintech platform.

    Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties include, but are not limited to: the outcome, cost, and timing of our product development activities and clinical trials; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; our ability to obtain and maintain regulatory approval of our drug product candidates, including our ability to receive timely approval of DaxibotulinumtoxinA for Injection; our ability to obtain funding for our operations; our plans to research, develop, and commercialize our drug product candidates; our ability to achieve market acceptance of our drug product candidates; unanticipated costs or delays in research, development, and commercialization efforts; the applicability of clinical study results to actual outcomes; the size and growth potential of the markets for our drug product candidates; our ability to successfully commercialize our drug product candidates and the timing of commercialization activities and anticipated product launches; the rate and degree of market acceptance of our drug product candidates; our ability to develop sales and marketing capabilities; the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for financing; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; and the impact of the COVID-19 pandemic on our manufacturing operations, supply chain, business operations, commercialization efforts, end user demand for our products, clinical trials and other aspects of our business. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in Revance's periodic filings with the Securities and Exchange Commission (the "SEC"), including factors described in the section entitled "Risks Factors" in the Registration Statement on Form 10Q filed with the SEC. The forward-looking statements in this press release speak only as of the date hereof. Revance disclaims any obligation to update these forward-looking statements.

    "Revance Therapeutics" and the Revance logo are registered trademarks of Revance Therapeutics, Inc.

    SOURCES

    1. Bertucci V, et al. "DaxibotulinumtoxinA for Injection has a prolonged duration of response in the treatment of glabellar lines: Pooled data from two multicenter, randomized, double-blind, placebo-controlled, phase 3 studies (SAKURA 1 and SAKURA 2)." J Am Acad Dermatol. 2019;82(4):838-845. doi: https://doi.org/10.1016/j.jaad.2019.06.1313
    2. Fabi SG, et al. "DaxibotulinumtoxinA for Injection for the Treatment of Glabellar Lines: Efficacy Results From SAKURA 3, a Large, Open-Label, Phase 3 Safety Study." Dermatologic Surgery. Published online August 6, 2020. doi: 10.1097/DSS.0000000000002531
    3. Green JB, et al. "A Large, Open-Label, Phase 3 Safety Study of DaxibotulinumtoxinA for Injection in Glabellar Lines: A Focus on Safety From the SAKURA 3 Study." Dermatologic Surgery. Published online August 6, 2020. doi: 10.1097/DSS.0000000000002463
    4. Clinicaltrials.gov. "Efficacy and Safety of Increasing Doses of DaxibotulinumtoxinA for Injection (DAXI for Injection) in the Treatment of Moderate or Severe Lateral Canthal Lines." Available at: https://clinicaltrials.gov/ct2/show/NCT03911102?term=DaxibotulinumtoxinA.

     

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  27. Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its investigational neuromodulator product, DaxibotulinumtoxinA for Injection, today announced new hire grants totaling an aggregate of 23,500 inducement restricted stock awards ("RSAs") to five employees. The RSAs vest over four years, with 25% of the underlying shares vesting on each of the four anniversaries of the applicable vesting commencement date, subject to the new employee's continued service relationship with Revance through the applicable vesting dates.

    The Compensation Committee of Revance's Board of Directors approved the awards as an inducement material to the new employees' employment in accordance…

    Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its investigational neuromodulator product, DaxibotulinumtoxinA for Injection, today announced new hire grants totaling an aggregate of 23,500 inducement restricted stock awards ("RSAs") to five employees. The RSAs vest over four years, with 25% of the underlying shares vesting on each of the four anniversaries of the applicable vesting commencement date, subject to the new employee's continued service relationship with Revance through the applicable vesting dates.

    The Compensation Committee of Revance's Board of Directors approved the awards as an inducement material to the new employees' employment in accordance with NASDAQ Listing Rule 5635(c)(4).

    About Revance Therapeutics, Inc.

    Revance Therapeutics, Inc. is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection. DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval in 2020. Revance is also evaluating DaxibotulinumtoxinA for Injection in the full upper face, including glabellar lines, forehead lines and crow's feet, as well as in three therapeutic indications - cervical dystonia, adult upper limb spasticity and plantar fasciitis. To accompany DaxibotulinumtoxinA for Injection, Revance owns a unique portfolio of premium products and services for U.S. aesthetics practices, including the exclusive U.S. distribution rights to the RHA® Collection of dermal fillers, the first and only range of FDA-approved fillers for correction of dynamic facial wrinkles and folds, and the HintMD fintech platform, which includes integrated smart payment, subscription and loyalty digital services. Revance has also partnered with Mylan N.V. to develop a biosimilar to BOTOX®, which would compete in the existing short-acting neuromodulator marketplace. Revance is dedicated to making a difference by transforming patient experiences. For more information or to join our team visit us at www.revance.com.

    "Revance Therapeutics" and the Revance logo are registered trademarks of Revance Therapeutics, Inc.

    RHA resilient hyaluronic acid® and RHA® are trademarks of TEOXANE SA.

    BOTOX® is a registered trademark of Allergan, Inc.

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  28. Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its investigational neuromodulator product, DaxibotulinumtoxinA for Injection, today announced that the company will participate in the Morgan Stanley 18th Annual Global Healthcare Conference, a fully virtual management access conference, taking place September 14-18.

    President and Chief Executive Officer, Mark Foley, is scheduled to participate in a virtual fireside chat on Monday, September 14, at 2:15 p.m. PT / 5:15 p.m. ET.

    Interested parties can access the live audio webcast for this conference from the Investor Relations section of the company's website at www.revance.com. The webcast replay will be…

    Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its investigational neuromodulator product, DaxibotulinumtoxinA for Injection, today announced that the company will participate in the Morgan Stanley 18th Annual Global Healthcare Conference, a fully virtual management access conference, taking place September 14-18.

    President and Chief Executive Officer, Mark Foley, is scheduled to participate in a virtual fireside chat on Monday, September 14, at 2:15 p.m. PT / 5:15 p.m. ET.

    Interested parties can access the live audio webcast for this conference from the Investor Relations section of the company's website at www.revance.com. The webcast replay will be available after the conclusion of the live presentation for approximately 30 days.

    About Revance Therapeutics, Inc.

    Revance Therapeutics, Inc. is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection. DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval in 2020. Revance is also evaluating DaxibotulinumtoxinA for Injection in the full upper face, including glabellar lines, forehead lines and crow's feet, as well as in three therapeutic indications - cervical dystonia, adult upper limb spasticity and plantar fasciitis. To accompany DaxibotulinumtoxinA for Injection, Revance owns a unique portfolio of premium products and services for U.S. aesthetics practices, including the exclusive U.S. distribution rights to the RHA® Collection of dermal fillers, the first and only range of FDA-approved fillers for correction of dynamic facial wrinkles and folds, and the HintMD fintech platform, which includes integrated smart payment, subscription and loyalty digital services. Revance has also partnered with Mylan N.V. to develop a biosimilar to BOTOX®, which would compete in the existing short-acting neuromodulator marketplace. Revance is dedicated to making a difference by transforming patient experiences. For more information or to join our team visit us at www.revance.com.

    "Revance Therapeutics" and the Revance logo are registered trademarks of Revance Therapeutics, Inc.

    RHA resilient hyaluronic acid® and RHA® are trademarks of TEOXANE SA.

    BOTOX® is a registered trademark of Allergan, Inc.

    Forward-Looking Statements

    This press release contains forward-looking statements, including statements related to Revance's financial outlook, milestone expectations, expected cash runway and financial performance; the planned commercial launch of our RHA® Collection of dermal fillers and the HintMD fintech platform, the process and timing of, and ability to complete, current and anticipated future clinical development of our investigational drug product candidates; the initiation, design, enrollment, submission, timing and results of our clinical studies, including the near-term milestone expectations described above; development of a biosimilar to BOTOX®; results of our non-clinical programs; statements about our business strategy, timeline and other goals and market for our anticipated products, plans and prospects, including our commercialization plans; statements about our ability to obtain, and the timing relating to, regulatory approval with respect to our drug product candidates, including with respect to the anticipated approval of DaxibotulinumtoxinA for Injection in glabellar lines and expected PDUFA date; and potential benefits of our drug product candidates and our technologies, including with respect to the RHA® line of dermal fillers and HintMD fintech platform.

    Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties include, but are not limited to: the outcome, cost, and timing of our product development activities and clinical trials; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; our ability to obtain and maintain regulatory approval of our drug product candidates, including our ability to receive timely approval of DaxibotulinumtoxinA for Injection; our ability to obtain funding for our operations; our plans to research, develop, and commercialize our drug product candidates; our ability to achieve market acceptance of our drug product candidates; unanticipated costs or delays in research, development, and commercialization efforts; the applicability of clinical study results to actual outcomes; the size and growth potential of the markets for our drug product candidates; our ability to successfully commercialize our drug product candidates and the timing of commercialization activities and anticipated product launches; the rate and degree of market acceptance of our drug product candidates; our ability to develop sales and marketing capabilities; the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for financing; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; and the impact of the COVID-19 pandemic on our manufacturing operations, supply chain, business operations, commercialization efforts, end user demand for our products, clinical trials and other aspects of our business. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in Revance's periodic filings with the Securities and Exchange Commission (the "SEC"), including factors described in the section entitled "Risks Factors" in the Registration Statement on quarterly Form 10Q filed with the SEC on August 6, 2020. The forward-looking statements in this press release speak only as of the date hereof. Revance disclaims any obligation to update these forward-looking statements.

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  29. Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its investigational neuromodulator product, DaxibotulinumtoxinA for Injection, today announced that the company will participate in the Wells Fargo Securities Healthcare Conference, a fully virtual management access conference, taking place September 9-10.

    President and Chief Executive Officer, Mark Foley, is scheduled to present on Wednesday, September 9, at 10:20 a.m. PT / 1:20 p.m. ET.

    Interested parties can access the live audio webcast for this conference from the Investor Relations section of the company's website at www.revance.com. The webcast replay will be available after the conclusion of the…

    Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its investigational neuromodulator product, DaxibotulinumtoxinA for Injection, today announced that the company will participate in the Wells Fargo Securities Healthcare Conference, a fully virtual management access conference, taking place September 9-10.

    President and Chief Executive Officer, Mark Foley, is scheduled to present on Wednesday, September 9, at 10:20 a.m. PT / 1:20 p.m. ET.

    Interested parties can access the live audio webcast for this conference from the Investor Relations section of the company's website at www.revance.com. The webcast replay will be available after the conclusion of the live presentation for approximately 30 days.

    About Revance Therapeutics, Inc.

    Revance Therapeutics, Inc. is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection. DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval in 2020. Revance is also evaluating DaxibotulinumtoxinA for Injection in the full upper face, including glabellar lines, forehead lines and crow's feet, as well as in three therapeutic indications - cervical dystonia, adult upper limb spasticity and plantar fasciitis. To accompany DaxibotulinumtoxinA for Injection, Revance owns a unique portfolio of premium products and services for U.S. aesthetics practices, including the exclusive U.S. distribution rights to the RHA® Collection of dermal fillers, the first and only range of FDA-approved fillers for correction of dynamic facial wrinkles and folds, and the HintMD fintech platform, which includes integrated smart payment, subscription and loyalty digital services. Revance has also partnered with Mylan N.V. to develop a biosimilar to BOTOX®, which would compete in the existing short-acting neuromodulator marketplace. Revance is dedicated to making a difference by transforming patient experiences. For more information or to join our team visit us at www.revance.com.

    "Revance Therapeutics" and the Revance logo are registered trademarks of Revance Therapeutics, Inc.

    RHA resilient hyaluronic acid® and RHA® are trademarks of TEOXANE SA.

    BOTOX® is a registered trademark of Allergan, Inc.

    Forward-Looking Statements

    This press release contains forward-looking statements, including statements related to Revance's financial outlook, milestone expectations, expected cash runway and financial performance; the planned commercial launch of our RHA® Collection of dermal fillers and the HintMD fintech platform, the process and timing of, and ability to complete, current and anticipated future clinical development of our investigational drug product candidates; the initiation, design, enrollment, submission, timing and results of our clinical studies, including the near-term milestone expectations described above; development of a biosimilar to BOTOX®; results of our non-clinical programs; statements about our business strategy, timeline and other goals and market for our anticipated products, plans and prospects, including our commercialization plans; statements about our ability to obtain, and the timing relating to, regulatory approval with respect to our drug product candidates, including with respect to the anticipated approval of DaxibotulinumtoxinA for Injection in glabellar lines and expected PDUFA date; and potential benefits of our drug product candidates and our technologies, including with respect to the RHA® line of dermal fillers and HintMD fintech platform.

    Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties include, but are not limited to: the outcome, cost, and timing of our product development activities and clinical trials; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; our ability to obtain and maintain regulatory approval of our drug product candidates, including our ability to receive timely approval of DaxibotulinumtoxinA for Injection; our ability to obtain funding for our operations; our plans to research, develop, and commercialize our drug product candidates; our ability to achieve market acceptance of our drug product candidates; unanticipated costs or delays in research, development, and commercialization efforts; the applicability of clinical study results to actual outcomes; the size and growth potential of the markets for our drug product candidates; our ability to successfully commercialize our drug product candidates and the timing of commercialization activities and anticipated product launches; the rate and degree of market acceptance of our drug product candidates; our ability to develop sales and marketing capabilities; the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for financing; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; and the impact of the COVID-19 pandemic on our manufacturing operations, supply chain, business operations, commercialization efforts, end user demand for our products, clinical trials and other aspects of our business. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in Revance's periodic filings with the Securities and Exchange Commission (the "SEC"), including factors described in the section entitled "Risks Factors" in the Registration Statement on quarterly Form 10Q filed with the SEC on August 6, 2020. The forward-looking statements in this press release speak only as of the date hereof. Revance disclaims any obligation to update these forward-looking statements.

    Source: Revance Therapeutics, Inc.

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  30. - Revance is positioned to introduce its innovative aesthetics portfolio, starting with the launch of the RHA® Collection, the first and only FDA-approved dermal fillers for correction of dynamic facial wrinkles and folds -

    - Clinical study results support the efficacy and safety of these globally established and innovative hyaluronic acid (HA) gels that represent the latest HA filler technology -

    - 100+ field force in place and trained for launch of the RHA® Collection, and roll out of the recently acquired fintech platform, HintMD -

    Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its investigational neuromodulator product, DaxibotulinumtoxinA for Injection…

    - Revance is positioned to introduce its innovative aesthetics portfolio, starting with the launch of the RHA® Collection, the first and only FDA-approved dermal fillers for correction of dynamic facial wrinkles and folds -

    - Clinical study results support the efficacy and safety of these globally established and innovative hyaluronic acid (HA) gels that represent the latest HA filler technology -

    - 100+ field force in place and trained for launch of the RHA® Collection, and roll out of the recently acquired fintech platform, HintMD -

    Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its investigational neuromodulator product, DaxibotulinumtoxinA for Injection, today announced that the company's field force is established and will begin introducing its prestige aesthetics portfolio, including the RHA® Collection of dermal fillers, resilient hyaluronic acid, and the HintMD financial technology (fintech) platform, in the United States (U.S.) in September.1

    Revance Commercial Launch

    Revance is ready to execute its first commercial product portfolio launch with the completion of onboarding and training processes for their 100+ field force team.

    The company plans to approach prestige aesthetic practices across the U.S., offering its first premium products and services, the RHA® Collection of dermal fillers, along with an integrated fintech platform, HintMD. The same commercial infrastructure is anticipated to roll out DaxibotulinumtoxinA for Injection for the treatment of glabellar lines upon FDA approval later this year. Revance has recently concluded the RHA® Collection PrevU early clinical experience education and training program for select practices ahead of the consumer launch of the RHA® Collection and plans to share observations in the near future.

    "Revance is positioned to re-energize the aesthetics industry with the creation of a prestige category of innovative products and services and elevated customer and patient experiences available through select practices. Our commercial team, comprised of industry experts with decades of aesthetics and commercial experience, is now trained and in position to execute Revance's first commercial launch," said Dustin S. Sjuts, Chief Commercial Officer. "We are delighted to be entering the market with the RHA® Collection, the latest innovation in HA technology, and an integrated fintech platform designed to transform existing payment processing ecosystems and improve both aesthetics practice economics and patient experiences. We plan to follow with our lead investigational candidate DaxibotulinumtoxinA for Injection after its anticipated approval, which is just around the corner."

    RHA® Collection of Dermal Fillers Clinical Study Results

    The RHA® Collection of dermal fillers represent the latest advancement in HA filler science and are designed with a crosslinking method that preserves the hyaluronic acid network to more closely mimic natural HA found in the skin. The gels are designed to be resilient and adapt to facial movement, which may provide a natural look at rest and in motion.2-5 The safety and efficacy of RHA® dermal fillers are well established, having been demonstrated through clinical studies, which have been published and presented globally, including:

    18-Month Head-to Head European Clinical Study Published in Dermatologic Surgery

    In an 18-month, head-to-head, randomized and controlled study published in Dermatologic Surgery, RHA® 2, 3, 4 were evaluated for efficacy, durability and safety versus other available comparator gels on the market for the treatment of nasolabial folds (NLF). Results showed: 6

    • Overall physician preference for RHA® Collection products due to ease of injection and product placement, immediate results, and results after massage of the injected tissue
    • High levels of improved satisfaction immediately after injection and in the long-term for both investigators and participating subjects
    • Fewer touch-ups were needed by (or at) day 14 with gels in the RHA® Collection (26.7% versus 35.6% with comparators)
    • Better long-term improvement of NLF volume with gels in the RHA® Collection based on 3D skin topography measurements.

    European Clinical Experience and Tissue Integration Analysis Published in Journal of Drugs in Dermatology

    Observations from clinical experience included7:

    • RHA® fillers blend well into wrinkles and folds with excellent tissue integration
    • RHA® 2 and RHA® 3 fillers could be used effectively in the superficial and mid-dermis for the treatment of perioral and marionette lines
    • RHA® 4 filler, when used for volumizing, injected very easily and, during the follow-up period, the treated areas remained supple and treatment results natural looking.

    U.S. FDA Approval Supported by Two 15-Month Studies Published in Dermatologic Surgery and the Journal of Cosmetic Dermatology

    In 2017, the FDA approved the RHA® Collection based on data from two U.S. studies, each a 15-month, prospective, multicenter, active-controlled, randomized, double-blinded, split-face clinical trial.2-4 Results included:5, 8

    • More than 90% of patients were satisfied or very satisfied with their results 12 months after treatment
    • Sustained clinical effectiveness, with over 80% of patients still maintaining a clinically meaningful response at 15 months
    • Favorable long-term safety profile, with no delayed-onset adverse events reported.

    The most frequent treatment-related adverse events reported in the U.S. clinical trials with RHA® 2, RHA® 3, and RHA® 4 were injection site firmness: 27.8%, 25.3%, 37.5%, lumps/bumps: 20.8%, 27.7%, 37.5%, tenderness: 9.7%, 13.3%, 15.8%, and injection site swelling reported in 8.3%, 12.0% and 19.2% of patients respectively. 2-5, 8

    The RHA® Collection is now available to select practices. Interested healthcare professionals are encouraged to visit RHACollection.com to receive product information and updates on the RHA® Collection.

    About Dermal Fillers in the United States

    Dermal fillers are injected into the superficial and deep layers of the skin to restore volume, smooth lines, provide facial lift and contour, plump the lips or improve the appearance of facial scars commonly caused by acne. Hyaluronic acid (HA) dermal fillers represent 88% of the total U.S. dermal filler market and are the second most frequently performed non-surgical aesthetic treatment after neuromodulator injections. The American Society of Aesthetic Plastic Surgery (ASAPS) reported HA dermal filler procedures have increased by more than 58% since 2014, with an estimated 810,240 HA dermal filler procedures performed in 2018.9

    Hyaluronic acid is naturally found in the body, primarily in the skin, joints and connective tissue. With age, human skin loses its ability to produce HA, resulting in loss of volume, firmness and elasticity. HA dermal fillers are manufactured from synthesized hyaluronic acid crosslinked to significantly enhance durability in the skin. These products can restore lost volume for six to 12 months or longer before the body gradually and naturally absorbs the HA.10 Most HA dermal fillers also contain lidocaine to help minimize discomfort during and after treatment.

    The U.S. dermal filler market is estimated to be $1.1 billion in 2019 and is expected to double to $2.2 billion by 2026.11

    RHA® Approved Use

    The RHA® collection of fillers is for injection into the facial tissue for the correction of dynamic facial wrinkles and folds that are moderate to severe, such as nasolabial folds, in adults 22 or older.

    IMPORTANT SAFETY INFORMATION

    Are there any reasons why I should not receive any RHA® injectable gel formulation? Do not receive if you have a history of multiple severe allergies or severe allergic reactions; if you are allergic to lidocaine or gram-positive bacterial proteins; or if you have a bleeding disorder.

    What precautions should I discuss with my doctor?

    • Tell your doctor if you are pregnant or breastfeeding, as the safety of these products for use during pregnancy or while breastfeeding has not been studied
    • Tell your doctor if you have a history of excessive scarring, keloid formations or pigmentation disorders, as use of these products may result in additional scars or changes in pigmentation
    • Tell your doctor if you are planning laser treatments or a chemical peel, as there is a possible risk of inflammation at the treatment site if these procedures are performed after treatment
    • Tell your doctor if you are on immunosuppressive therapy used to decrease your immune response, as use of these products may result in an increased risk of infection
    • Tell your doctor if you are using medications that can prolong bleeding, such as aspirin, ibuprofen, or other blood thinners, as this may increase bruising or bleeding at the injection site
    • The safety and effectiveness of RHA® fillers in areas other than those indicated have not been established in U.S. clinical studies
    • Patients who experience skin injury near the site of injection with this product may be at a higher risk for side effects
    • Minimize strenuous exercise, exposure to extensive sun or heat, and alcoholic beverages within the first 24 hours following treatment

    What are possible side effects?

    The most commonly reported side effects included injection-site redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching.

    One of the risks with using these products is unintentional injection into a blood vessel, and while rare, the complications can be serious and may be permanent. These complications, which have been reported for facial injections, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring. As with all skin injection procedures, there is a risk of infection and recurrence of herpetic eruptions.

    To report a side effect with any RHA® product, please call Revance at (877) 373-8669. Please visit RHACollection.com or talk to your doctor for more information. Available by prescription only.

    Revance Therapeutics and the Revance logo are registered trademarks of Revance Therapeutics, Inc. RHA is a registered trademark of TEOXANE SA.

    ©2020 Revance Therapeutics®, Inc.

    About Revance Therapeutics, Inc.

    Revance Therapeutics, Inc. is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection. DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval in 2020. Revance is also evaluating DaxibotulinumtoxinA for Injection in the full upper face, including glabellar lines, forehead lines and crow's feet, as well as in three therapeutic indications - cervical dystonia, adult upper limb spasticity and plantar fasciitis. To accompany DaxibotulinumtoxinA for Injection, Revance owns a unique portfolio of premium products and services for U.S. aesthetics practices, including the exclusive U.S. distribution rights to the RHA® Collection of dermal fillers, the first and only range of FDA-approved fillers for correction of dynamic facial wrinkles and folds, and the HintMD fintech platform, which includes integrated smart payment, subscription and loyalty digital services. Revance has also partnered with Mylan N.V. to develop a biosimilar to BOTOX®, which would compete in the existing short-acting neuromodulator marketplace. Revance is dedicated to making a difference by transforming patient experiences. For more information or to join our team visit us at www.revance.com.

    "Revance Therapeutics" and the Revance logo are registered trademarks of Revance Therapeutics, Inc.

    RHA resilient hyaluronic acid® and RHA® are trademarks of TEOXANE SA.

    BOTOX® is a registered trademark of Allergan, Inc.

    About TEOXANE SA

    TEOXANE Laboratories, a private company, was established in Geneva in 2003, by Madame Valérie Taupin and specializes in the design and manufacturing of hyaluronic acid-based dermal fillers and cosmeceuticals. As a result of this uncompromising commitment to innovation, quality and patient satisfaction, TEOXANE Laboratories is now among the top hyaluronic acid-based dermal filler manufacturers in the world, with products sold across more than 90 countries.

    Moreover, with its scientific expertise, TEOXANE is one of the first Swiss laboratories offering a range of innovative cosmeceutical care formulated with cross-linked hyaluronic acid from its patented process, RHA resilient hyaluronic acid®. The cosmeceutical range TEOXANE is designed for patients who have undergone aesthetic medical procedures and continue their skin care with a targeted cosmetic routine designed specifically for them.

    For more information go to www.teoxane.com.

    Forward-Looking Statements

    This press release contains forward-looking statements, including statements related to Revance's financial outlook, milestone expectations, expected cash runway and financial performance; the planned commercial launch of our RHA® Collection of dermal fillers and the HintMD fintech platform, the process and timing of, and ability to complete, current and anticipated future clinical development of our investigational drug product candidates; the initiation, design, enrollment, submission, timing and results of our clinical studies, including the near-term milestone expectations described above; development of a biosimilar to BOTOX®; results of our non-clinical programs; statements about our business strategy, timeline and other goals and market for our anticipated products, plans and prospects, including our commercialization plans; statements about our ability to obtain, and the timing relating to, regulatory approval with respect to our drug product candidates, including with respect to the anticipated approval of DaxibotulinumtoxinA for Injection in glabellar lines and expected PDUFA date; and potential benefits of our drug product candidates and our technologies, including with respect to the RHA® line of dermal fillers and HintMD fintech platform.

    Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties include, but are not limited to: the outcome, cost, and timing of our product development activities and clinical trials; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; our ability to obtain and maintain regulatory approval of our drug product candidates, including our ability to receive timely approval of DaxibotulinumtoxinA for Injection; our ability to obtain funding for our operations; our plans to research, develop, and commercialize our drug product candidates; our ability to achieve market acceptance of our drug product candidates; unanticipated costs or delays in research, development, and commercialization efforts; the applicability of clinical study results to actual outcomes; the size and growth potential of the markets for our drug product candidates; our ability to successfully commercialize our drug product candidates and the timing of commercialization activities and anticipated product launches; the rate and degree of market acceptance of our drug product candidates; our ability to develop sales and marketing capabilities; the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for financing; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; and the impact of the COVID-19 pandemic on our manufacturing operations, supply chain, business operations, commercialization efforts, end user demand for our products, clinical trials and other aspects of our business. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in Revance's periodic filings with the Securities and Exchange Commission (the "SEC"), including factors described in the section entitled "Risks Factors" in the Registration Statement on Form 10Q filed with the SEC on August 6, 2020. The forward-looking statements in this press release speak only as of the date hereof. Revance disclaims any obligation to update these forward-looking statements.

    "Revance Therapeutics" and the Revance logo are registered trademarks of Revance Therapeutics, Inc.

    SOURCES

    1. RHA® is a trademark of TEOXANE SA. RHA® 2, RHA® 3, RHA® 4 are products of TEOXANE SA. They are class III medical devices and have received FDA approval. The United States Federal law restricts these devices to sale by or on the order of a physician or license practitioner. RHA® 2, RHA® 3 and RHA® 4 are indicated for the correction of moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds (NLF), in adults aged 22 years or older. RHA® 2, RHA® 3, and RHA® 4 are sterile gels containing crosslinked hyaluronic acid in physiological buffer and 0.3% lidocaine hydrochloride to reduce pain on injection. RHA® 2, RHA® 3 and RHA® 4 are contraindicated in patients with previous hypersensitivity to local anesthetics of the amide type, such as lidocaine. Please refer to the Instructions for Use (https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170002C.pdf). It is the practitioner's full responsibility to read and inform the patient about contraindications, warnings, precautions, risks and benefits.
    2. RHA®2 Directions for Use Patient Information
    3. RHA®3 Directions for Use Patient Information
    4. RHA®4 Directions for Use Patient Information
    5. Monheit G, Kaufman-Janette J, Joseph JH, Shamban A, Dover JS, Smith S. Efficacy and Safety of Two Resilient Hyaluronic Acid Fillers in the Treatment of Moderate-to-Severe Nasolabial Folds: A 64-Week, Prospective, Multicenter, Controlled, Randomized, Double-Blinded, and Within-Subject Study [published online ahead of print, 2020 Mar 24]. Dermatol Surg. 2020;10.1097/DSS.0000000000002391. doi:10.1097/DSS.0000000000002391
    6. Rzany B, Converset-Viethel S, Hartmann M, et al. Efficacy and Safety of 3 New Resilient Hyaluronic Acid Fillers, Crosslinked With Decreased BDDE, for the Treatment of Dynamic Wrinkles: Results of an 18-Month, Randomized Controlled Trial Versus Already Available Comparators. Dermatol Surg. 2019;45(10):1304-1314. doi:10.1097/DSS.0000000000001971
    7. Micheels P, Sarazin D, Besse S, Eliasd B. Comparison of Two Swiss-Designed Hyaluronic Acid Gels: Six-Month Clinical Follow-Up. J Drugs Dermatol. 2017;16(2):154-161.
    8. Kaufman-Janette J, Taylor SC, Cox SE, Weinkle SH, Smith S, Kinney BM. Efficacy and safety of a new resilient hyaluronic acid dermal filler, in the correction of moderate-to-severe nasolabial folds: A 64-week, prospective, multicenter, controlled, randomized, double-blind and within-subject study [published online ahead of print, 2019 Aug 24]. J Cosmet Dermatol. 2019;10.1111/jocd.13100. doi:10.1111/jocd.13100
    9. https://www.surgery.org/sites/default/files/ASAPS-Stats2018_0.pdf ASAPS-Stats2018-Proof5e - surgery.org
    10. https://www.fda.gov/medical-devices/cosmetic-devices/dermal-fillers-approved-center-devices-and-radiological-health
    11. DRG – Medtech 360 "Aesthetic Injectables | Market Analysis | US | 2019", Medical Insights – "The Global Aesthetics Market Study – XVII", ASPS – "Plastic Surgery Statistics" (2019 report)

     

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  31. - The SAKURA 3 safety and efficacy results are consistent with those observed in SAKURA 1 and SAKURA 2 studies for DaxibotulinumtoxinA for Injection in the treatment of glabellar (frown) lines –

    Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its investigational neuromodulator product, DaxibotulinumtoxinA for Injection, today announced the publication of two separate peer-reviewed articles in Dermatologic Surgery, the official journal of the American Society for Dermatologic Surgery (ASDS). The two peer-reviewed publications reported efficacy data as well as detailed safety results from the SAKURA 3 Phase 3 open-label, long-term safety study. The SAKURA…

    - The SAKURA 3 safety and efficacy results are consistent with those observed in SAKURA 1 and SAKURA 2 studies for DaxibotulinumtoxinA for Injection in the treatment of glabellar (frown) lines –

    Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its investigational neuromodulator product, DaxibotulinumtoxinA for Injection, today announced the publication of two separate peer-reviewed articles in Dermatologic Surgery, the official journal of the American Society for Dermatologic Surgery (ASDS). The two peer-reviewed publications reported efficacy data as well as detailed safety results from the SAKURA 3 Phase 3 open-label, long-term safety study. The SAKURA 3 study is part of the largest Phase 3 clinical development program for a neuromodulator in the treatment of glabellar lines.

    The Phase 3, open-label, multicenter trial evaluated single and repeat treatments in subjects receiving DaxibotulinumtoxinA for Injection for the treatment of moderate or severe glabellar lines. The study was conducted at 65 centers and with a total of 2,691 enrolled subjects who received one to three doses of DaxibotulinumtoxinA for Injection for a total of 3,830 treatments.

    In the first paper, the efficacy of DaxibotulinumtoxinA for Injection was not only highly consistent across successive treatment cycles and multiple end points evaluating response rates and duration of effect, but also confirmed results seen in the pivotal Phase 3 trials.1

    Results that were found to be complementary to SAKURA 1 and 2 included:

    • Median duration for return to moderate or severe wrinkle severity was 24 weeks; and
    • Median time to return to baseline severity was 28 weeks.

    Additional results include high (>96%) response rates (based on the proportion of patients achieving none or mild severity) on the Investigator Global Assessment–Frown Wrinkle Severity (IGA-FWS) scale seen after each of the three treatments.

    "The data published in Dermatologic Surgery replicate the previously reported safety and efficacy results observed in the two pivotal SAKURA studies with DaxibotulinumtoxinA for Injection in a substantially larger sample size of almost 2700 subjects at 65 clinical sites in the US and Canada," said Roman Rubio, Senior Vice President of Clinical Development at Revance. "The publication of these results further demonstrates the consistency of DaxibotulinumtoxinA for Injection to offer a long duration of response in the treatment of glabellar lines while being generally well-tolerated."

    The second data set, published in the same journal, showed that the safety profile of DaxibotulinumtoxinA for Injection was consistent within the pivotal SAKURA 1 and 2 studies, as well as with what was observed in other FDA-approved botulinum toxin products for glabellar lines1. Adverse events (AEs) were consistent across treatments and no new safety signals were observed. Treatment-related AEs occurred in 17.8% of subjects and were generally mild in severity. As previously reported, no serious AEs were treatment-related, and AEs reported were comparable with those in Phase 3 trials of other botulinum toxin type A products for treatment of glabellar lines. Headache was the most frequently reported AE in this trial (5.9%) and eyelid ptosis occurred in 0.9% of treatments.

    About Revance Therapeutics, Inc.

    Revance Therapeutics, Inc. is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection. DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval in 2020. Revance is also evaluating DaxibotulinumtoxinA for Injection in the full upper face, including glabellar lines, forehead lines and crow's feet, as well as in three therapeutic indications - cervical dystonia, adult upper limb spasticity and plantar fasciitis. To accompany DaxibotulinumtoxinA for Injection, Revance owns a unique portfolio of premium products and services for U.S. aesthetics practices, including the exclusive U.S. distribution rights to the RHA® Collection of dermal fillers, the first and only range of FDA-approved fillers for correction of dynamic facial wrinkles and folds, and the HintMD fintech platform, which includes integrated smart payment, subscription and loyalty digital services. Revance has also partnered with Mylan N.V. to develop a biosimilar to BOTOX®, which would compete in the existing short-acting neuromodulator marketplace. Revance is dedicated to making a difference by transforming patient experiences. For more information or to join our team visit us at www.revance.com.

    "Revance Therapeutics" and the Revance logo are registered trademarks of Revance Therapeutics, Inc.

    Resilient Hyaluronic Acid® and RHA® are trademarks of TEOXANE SA.

    BOTOX® is a registered trademark of Allergan, Inc.

    Forward-Looking Statement: Revance Therapeutics

    This press release contains forward-looking statements, including statements related to Revance's financial outlook, milestone expectations, expected cash runway and financial performance; the planned commercial launch of our RHA® Collection of dermal fillers and the HintMD fintech platform, the process and timing of, and ability to complete, current and anticipated future clinical development of our investigational drug product candidates; the initiation, design, enrollment, submission, timing and results of our clinical studies, including the near-term milestone expectations described above; development of a biosimilar to BOTOX®; results of our non-clinical programs; statements about our business strategy, timeline and other goals and market for our anticipated products, plans and prospects, including our commercialization plans; statements about our ability to obtain, and the timing relating to, regulatory approval with respect to our drug product candidates, including with respect to the anticipated approval of DaxibotulinumtoxinA for Injection in glabellar lines and expected PDUFA date; and potential benefits of our drug product candidates and our technologies, including with respect to the RHA® line of dermal fillers and HintMD fintech platform.

    Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties include, but are not limited to: the outcome, cost, and timing of our product development activities and clinical trials; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; our ability to obtain and maintain regulatory approval of our drug product candidates, including our ability to receive timely approval of DaxibotulinumtoxinA for Injection; our ability to obtain funding for our operations; our plans to research, develop, and commercialize our drug product candidates; our ability to achieve market acceptance of our drug product candidates; unanticipated costs or delays in research, development, and commercialization efforts; the applicability of clinical study results to actual outcomes; the size and growth potential of the markets for our drug product candidates; our ability to successfully commercialize our drug product candidates and the timing of commercialization activities and anticipated product launches; the rate and degree of market acceptance of our drug product candidates; our ability to develop sales and marketing capabilities; the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for financing; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; and the impact of the COVID-19 pandemic on our manufacturing operations, supply chain, business operations, commercialization efforts, end user demand for our products, clinical trials and other aspects of our business. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in Revance's periodic filings with the Securities and Exchange Commission (the "SEC"), including factors described in the section entitled "Risks Factors" in the Registration Statement on Form S-4/A filed with the SEC on June 23, 2020. The forward-looking statements in this press release speak only as of the date hereof. Revance disclaims any obligation to update these forward-looking statements.

    "Revance Therapeutics" and the Revance logo are registered trademarks of Revance Therapeutics, Inc.

    SOURCES:

    1. Carruthers JD, Fagien S, Joseph JH, Humphrey SD, et al. DaxibotulinumtoxinA in the treatment of glabellar lines: results from each of two multicenter, randomized, double-blind, placebo-controlled phase 3 studies (SAKURA 1 and SAKURA 2). Plast Reconstr Surg 2020;145:45–58.

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  32. - Conference call and webcast today at 4:30 p.m. ET -

    Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its investigational neuromodulator product, DaxibotulinumtoxinA for Injection, today reported financial results for the quarter ended June 30, 2020, and provided a corporate update.

    Key Second Quarter 2020 and Subsequent Updates

    • Commercial Launch of RHA® Collection of Dermal Fillers On-Track for Third Quarter. Revance has received product supply (RHA® 2, 3 and 4) from Teoxane SA, initiated its PrevU Early Clinical Experience Program and completed the hiring of its initial field force, with plans to commence sales of the RHA® Collection in September…

    - Conference call and webcast today at 4:30 p.m. ET -

    Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its investigational neuromodulator product, DaxibotulinumtoxinA for Injection, today reported financial results for the quarter ended June 30, 2020, and provided a corporate update.

    Key Second Quarter 2020 and Subsequent Updates

    • Commercial Launch of RHA® Collection of Dermal Fillers On-Track for Third Quarter. Revance has received product supply (RHA® 2, 3 and 4) from Teoxane SA, initiated its PrevU Early Clinical Experience Program and completed the hiring of its initial field force, with plans to commence sales of the RHA® Collection in September.
    • Completed the Acquisition of HintMD - A Proprietary Fintech Platform for Aesthetic Practices. In May, Revance announced the signing of a definitive agreement to acquire Hint, Inc., a privately held company doing business under the name HintMD, which has created an integrated financial technology (fintech) platform for the aesthetics industry. The acquisition closed on July 23, 2020 and integration is underway. The commercial launch of the HintMD fintech platform, concurrent with the RHA® Collection, is planned for September.
    • Announced Positive Results in Two Phase 2a Studies of DaxibotulinumtoxinA for Injection for the Treatment of Forehead Lines and Crow's Feet, Respectively. In June, Revance announced results for two Phase 2a open-label, dose escalation studies of its investigational drug candidate DaxibotulinumtoxinA for Injection in the treatment of dynamic forehead lines (FHL) following glabellar (frown) line injections and lateral canthal lines (LCL), commonly known as crow's feet. The studies evaluated a range of doses and, while not powered to provide clinical significance, at least one dose in each study demonstrated a measurable treatment effect (defined as at least a one-point change from baseline in wrinkle severity as assessed by the investigator) in 100% of subjects at 4 weeks, with median duration (defined as the median time to return to baseline wrinkle severity based on both investigator and patient assessment ) of 27 weeks in forehead lines and 24 weeks in crow's feet.
    • DaxibotulinumtoxinA for Injection potential November approval in glabellar lines. In February of this year, the company received U.S. Food and Drug Administration (FDA) notification that its Biologics License Application (BLA) for DaxibotulinumtoxinA for Injection in the treatment of moderate to severe glabellar (frown) lines was accepted for review. Revance has been given a target action date under the Prescription Drug User Fee Act (PDUFA) of November 25, 2020.
    • Completed enrollment in the ASPEN-OLS Phase 3 Open-Label, Long-Term Safety Trial. Revance's ASPEN Phase 3 clinical program consists of two trials to evaluate the safety and efficacy of DaxibotulinumtoxinA for Injection for the treatment of cervical dystonia in adults: ASPEN-1 and ASPEN-OLS. In June, Revance completed enrollment in its ASPEN-OLS long-term safety trial with a total of 358 subjects. Enrollment in the pivotal trial, ASPEN-1, was completed in October 2019 and is on-track to have topline results reported in the fall of 2020.
    • Topline Results for Phase 2 Plantar Fasciitis Trial on Track for Fall Readout. In March, Revance announced that its Phase 2 study of DaxibotulinumtoxinA for Injection in plantar fasciitis was fully enrolled, with all subjects dosed and past the primary endpoint visit. The company expects to report topline results from this placebo-controlled study in fall 2020.
    • Enrolled Last Patient in Modified JUNIPER Phase 2 Upper Limb Spasticity Trial. In June, Revance announced its decision to complete enrollment in its JUNIPER Phase 2 trial of DaxibotulinumtoxinA for Injection for the treatment of upper limb spasticity in adults after stroke or traumatic brain injury. Due to ongoing COVID-19 concerns related to subject enrollment and scheduling in-person study visits, the company chose to end screening and complete the study with 83 subjects enrolled. Revance now expects to announce topline data from the JUNIPER Phase 2 trial in early 2021.
    • Revance and Mylan to Advance Development Program for Biosimilar to BOTOX®. In June, Revance announced Mylan's decision to move forward with a development plan, under a 351(k) pathway, for a proposed biosimilar to BOTOX® and BOTOX® Cosmetic (onabotulinumtoxinA). With Mylan's decision to move forward with the development program, a milestone payment of $30 million was made to Revance by Mylan in the second quarter.

    "The second quarter was a transformational period for the company, marked by many significant accomplishments, despite the challenges resulting from the COVID-19 pandemic. Of particular note was the acquisition of HintMD, which provides us with an exciting and complementary fintech platform that will meaningfully enhance our ability to partner with aesthetic practices, deliver incremental value, and provide Revance with a healthy source of recurring revenue," said Mark Foley, President and Chief Executive Officer. "Looking ahead to the second half of 2020, we enter a catalyst-rich period, beginning with the planned commercial launch of our RHA® Collection of dermal fillers and the HintMD fintech platform in September. Then, in the fall, we plan to report the topline results from our ASPEN-1 Phase 3 cervical dystonia trial and Phase 2 plantar fasciitis study. Lastly, we remain on track for potential U.S. regulatory approval of DaxibotulinumtoxinA for Injection, in the treatment of glabellar lines, in November. As we make the transition from a pre-commercial to a commercial entity, I am incredibly excited about our future and firmly believe that we have the right people, products and strategy in place to successfully compete in both the aesthetic and therapeutic markets."

    Financial Highlights

    Cash, cash equivalents and short-term investments as of June 30, 2020 were $494.0 million.

    Revenue for the quarter ended June 30, 2020 was $0.3 million with no revenue recognized in the same period in 2019. Revenue for the six months ended June 30, 2020 was $0.4 million compared to $0.3 million for the same period in 2019. Revenue recognized for the quarter consists of both the initial sale of the RHA® Collection of dermal fillers in connection with the PrevU Program and activities related to the Mylan collaboration for the biosimilar to BOTOX® program.

    Cost of revenue (exclusive of amortization) for the quarter is minimal and is related to cost of RHA® Collection inventory delivered as part of the PrevU Program.

    Research and development expenses for the three and six months ended June 30, 2020 were $27.1 million and $66.9 million compared to $25.5 million and $49.5 million for the same periods in 2019, respectively. A non-cash acquisition charge of $11.2 million was allocated to in-process research and development from the TEOXANE distribution agreement in the first quarter of 2020.

    Selling, general and administrative expenses for the three and six months ended June 30, 2020 were $29.6 million and $50.8 million compared to $13.6 million and $26.5 million for the same periods in 2019, respectively. The increase in selling, general and administrative expenses is primarily due to increased costs related to commercial activities, HintMD acquisition related costs, human capital, and infrastructure build-out.

    Total operating expenses for the three and six months ended June 30, 2020 were $57.4 million and $118.4 million compared to $39.1 million and $76.0 million for the same periods in 2019, respectively. Depreciation and amortization for the three and six months ended June 30, 2020 was $1.4 million and $2.2 million, respectively. Stock-based compensation for the three and six months ended June 30, 2020 was $7.4 million and $13.9 million, respectively. When excluding depreciation and amortization, stock-based compensation, and non-cash in-process research and development, total operating expenses for the three and six months ended June 30, 2020 were $48.6 million and $91.2 million, respectively.

    Net loss for the three and six months ended June 30, 2020 was $60.6 million and $122.5 million compared to $37.4 million and $72.7 million for the same periods in 2019, respectively.

    Near-Term Milestone Expectations

    Aesthetics:

    • Commercial launch of HintMD and RHA® Collection of dermal fillers expected in September 2020.
    • Topline results from Phase 2 open-label, dose-escalation study of DaxibotulinumtoxinA for Injection in upper facial lines expected in 4Q 2020.
    • Prescription Drug User Fee Act (PDUFA) date of November 25, 2020, for potential U.S. Food and Drug Administration (FDA) approval of DaxibotulinumtoxinA for Injection in glabellar lines.

    Therapeutics:

    • Topline results from ASPEN-1 Phase 3 placebo-controlled, parallel-group study of DaxibotulinumtoxinA for Injection in cervical dystonia expected in fall 2020.
    • Topline results from Phase 2 placebo-controlled study of DaxibotulinumtoxinA for Injection in plantar fasciitis expected in fall 2020.
    • Topline results from JUNIPER Phase 2 placebo-controlled, dose-ranging study of DaxibotulinumtoxinA for Injection in upper limb spasticity expected in early 2021.

    2020 Financial Outlook

    We are developing our acquisition accounting for HintMD and once completed we can provide GAAP operating expense guidance for 2020. Nevertheless, Revance expects non-GAAP (U.S. generally accepted accounting principles, or GAAP) operating expense, which excludes depreciation and amortization, stock-based compensation, and non-cash in-process research and development costs, to be in the range of $220 to $230 million. With multiple clinical programs underway, along with regulatory and pre-commercial manufacturing activities, Revance anticipates 2020 non-GAAP, non-HintMD related research and development expense to be $95 to $100 million. With current cash and equivalents, management projects that the company is funded into 2023.

    Conference Call

    Individuals interested in listening to the conference call may do so by dialing (855) 453-3827 for domestic callers, or (484) 756-4301 for international callers and reference conference ID: 4968933; or from the webcast link in the investor relations section of the company's website at: www.revance.com. A replay of the call will be available beginning August 6, 2020 at 4:30 p.m. PT/7:30 p.m. ET to August 7, 2020 at 4:30 p.m. PT/7:30 p.m. ET. To access the replay, dial (855) 859-2056 or (404) 537-3406 and reference conference ID: 4968933.

    The live webcast can be accessed here and will be available in the investor relations section on the company's website for 30 days following the completion of the call. In light of reduced call center resources during this time of required social-distancing, Revance requests that listeners who do not plan on participating in the question and answer session listen to the live webcast rather than dialing in by phone.

    About Revance Therapeutics, Inc.

    Revance Therapeutics, Inc. is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection. DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval in 2020. Revance is also evaluating DaxibotulinumtoxinA for Injection in the full upper face, including glabellar lines, forehead lines and crow's feet, as well as in three therapeutic indications - cervical dystonia, adult upper limb spasticity and plantar fasciitis. To accompany DaxibotulinumtoxinA for Injection, Revance owns a unique portfolio of premium products and services for U.S. aesthetics practices, including the exclusive U.S. distribution rights to the RHA® Collection of dermal fillers, the first and only range of FDA-approved fillers for correction of dynamic facial wrinkles and folds, and the HintMD fintech platform, which includes integrated smart payment, subscription and loyalty digital services. Revance has also partnered with Mylan N.V. to develop a biosimilar to BOTOX®, which would compete in the existing short-acting neuromodulator marketplace. Revance is dedicated to making a difference by transforming patient experiences. For more information or to join our team visit us at www.revance.com.

    "Revance Therapeutics" and the Revance logo are registered trademarks of Revance Therapeutics, Inc.

    Resilient Hyaluronic Acid® and RHA® are trademarks of TEOXANE SA.

    BOTOX® is a registered trademark of Allergan, Inc.

    Forward-Looking Statements

    This press release contains forward-looking statements, including statements related to Revance's financial outlook, milestone expectations, expected cash runway and financial performance; the planned commercial launch of our RHA® Collection of dermal fillers and the HintMD fintech platform, the process and timing of, and ability to complete, current and anticipated future clinical development of our investigational drug product candidates; the initiation, design, enrollment, submission, timing and results of our clinical studies, including the near-term milestone expectations described above; development of a biosimilar to BOTOX®; results of our non-clinical programs; statements about our business strategy, timeline and other goals and market for our anticipated products, plans and prospects, including our commercialization plans; statements about our ability to obtain, and the timing relating to, regulatory approval with respect to our drug product candidates, including with respect to the anticipated approval of DaxibotulinumtoxinA for Injection in glabellar lines and expected PDUFA date; and potential benefits of our drug product candidates and our technologies, including with respect to the RHA® line of dermal fillers and HintMD fintech platform.

    Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties include, but are not limited to: the outcome, cost, and timing of our product development activities and clinical trials; the uncertain clinical development process, including the risk that clinical trials may not have an effective design or generate positive results; our ability to obtain and maintain regulatory approval of our drug product candidates, including our ability to receive timely approval of DaxibotulinumtoxinA for Injection; our ability to obtain funding for our operations; our plans to research, develop, and commercialize our drug product candidates; our ability to achieve market acceptance of our drug product candidates; unanticipated costs or delays in research, development, and commercialization efforts; the applicability of clinical study results to actual outcomes; the size and growth potential of the markets for our drug product candidates; our ability to successfully commercialize our drug product candidates and the timing of commercialization activities and anticipated product launches; the rate and degree of market acceptance of our drug product candidates; our ability to develop sales and marketing capabilities; the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for financing; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; and the impact of the COVID-19 pandemic on our manufacturing operations, supply chain, business operations, commercialization efforts, end user demand for our products, clinical trials and other aspects of our business. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in Revance's periodic filings with the Securities and Exchange Commission (the "SEC"), including factors described in the section entitled "Risks Factors" in the Registration Statement on Form S-4/A filed with the SEC on June 23, 2020. The forward-looking statements in this press release speak only as of the date hereof. Revance disclaims any obligation to update these forward-looking statements.

    Use of Non-GAAP Financial Measures

    Revance has presented certain non-GAAP financial measures in this release. This release and the reconciliation tables included herein include total non-GAAP operating expense and non-GAAP R&D expense, both of which exclude depreciation and amortization, stock-based compensation, and non-cash in-process research and development costs. Revance excludes depreciation and amortization, stock-based compensation, and non-cash in-process research and development costs because management believes the exclusion of these items is helpful to investors to evaluate Revance's recurring operational performance. Revance management uses these non-GAAP financial measures to monitor and evaluate its operating results and trends on an on-going basis, and internally for operating, budgeting and financial planning purposes. The non-GAAP financial measures should be considered in addition to results prepared in accordance with GAAP but should not be considered a substitute for or superior to GAAP results.

     

    REVANCE THERAPEUTICS, INC.

    Condensed Consolidated Balance Sheets

    (In thousands, except share and per share amounts)

    (Unaudited)

     

     

    June 30,

     

    December 31,

     

    2020

     

     

    2019

     

    ASSETS

    CURRENT ASSETS

     

     

     

    Cash and cash equivalents

    $

    363,511

     

     

     

    $

    171,160

     

     

    Short-term investments

    130,532

     

     

     

    118,955

     

     

    Accounts receivable

    49

     

     

     

     

     

    Inventories

    778

     

     

     

     

     

    Prepaid expenses and other current assets

    7,901

     

     

     

    6,487

     

     

    Total current assets

    502,771

     

     

     

    296,602

     

     

    Property and equipment, net

    13,695

     

     

     

    14,755

     

     

    Intangible assets, net

    31,660

     

     

     

     

     

    Operating lease right of use assets

    25,366

     

     

     

    26,531

     

     

    Restricted cash

    1,050

     

     

     

    730

     

     

    Other non-current assets

    1,639

     

     

     

    1,669

     

     

    TOTAL ASSETS

    $

    576,181

     

     

     

    $

    340,287

     

     

    LIABILITIES AND STOCKHOLDERS' EQUITY

    CURRENT LIABILITIES

     

     

     

    Accounts payable

    $

    6,603

     

     

     

    $

    8,010

     

     

    Accruals and other current liabilities

    22,245

     

     

     

    18,636

     

     

    Deferred revenue, current portion

    12,255

     

     

     

    7,911

     

     

    Operating lease liabilities, current portion

    3,789

     

     

     

    3,470

     

     

    Derivative liability

    3,101

     

     

     

    2,952

     

     

    Total current liabilities

    47,993

     

     

     

    40,979

     

     

    Convertible senior notes

    174,304

     

     

     

     

     

    Deferred revenue, net of current portion

    74,295

     

     

     

    47,948

     

     

    Operating lease liabilities, net of current portion

    23,871

     

     

     

    25,870

     

     

    TOTAL LIABILITIES

    320,463

     

     

     

    114,797

     

     

    STOCKHOLDERS' EQUITY

     

     

     

    Convertible preferred stock, par value $0.001 per share — 5,000,000 shares authorized, and no shares issued and outstanding as of June 30, 2020 and December 31, 2019

     

     

     

     

     

    Common stock, par value $0.001 per share — 95,000,000 shares authorized both as of June 30, 2020 and December 31, 2019; 57,313,556 and 52,374,735 shares issued and outstanding as of June 30, 2020 and December 31, 2019, respectively

    57

     

     

     

    52

     

     

    Additional paid-in capital

    1,222,271

     

     

     

    1,069,639

     

     

    Accumulated other comprehensive income

    117

     

     

     

    3

     

     

    Accumulated deficit

    (966,727

    )

     

     

    (844,204

    )

     

    TOTAL STOCKHOLDERS' EQUITY

    255,718

     

     

     

    225,490

     

     

    TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY

    $

    576,181

     

     

     

    $

    340,287

     

     

     

    REVANCE THERAPEUTICS, INC.

    Condensed Consolidated Statements of Operations and Comprehensive Loss

    (In thousands, except share and per share amounts)

    (Unaudited)

     

     

    Three Months Ended June 30,

     

    Six Months Ended June 30,

     

    2020

     

     

    2019

     

     

    2020

     

     

    2019

     

    Revenue

    $

    299

     

     

     

    $

     

     

     

    $

    357

     

     

     

    $

    278