HRMY Harmony Biosciences Holdings Inc.

34.9
-1.33  -4%
Previous Close 36.23
Open 36.32
52 Week Low 28.965
52 Week High 52.74
Market Cap $1,985,429,974
Shares 56,889,111
Float 10,705,696
Enterprise Value $1,988,974,767
Volume 146,979
Av. Daily Volume 111,898
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Upcoming Catalysts

Drug Stage Catalyst Date
WAKIX (pitolisant)
Excessive daytime sleepiness associated with Prader-Willi Syndrome
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
WAKIX (pitolisant)
Myotonic dystrophy
Phase 2
Phase 2
Phase 2 trial to be initiated 1H 2021.
WAKIX (pitolisant)
Adult cataplexy
Approved
Approved
FDA approval announced October 14, 2020.

Latest News

  1. PLYMOUTH MEETING, Pa., March 2, 2021 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony") (NASDAQ:HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, announced today that the company has been certified by independent analysts as a Great Place to Work® for the third year in a row. This certification is based on validated feedback from Harmony's employees in an anonymous survey intended to determine exceptional workplace cultures.

    "At Harmony, our team works hard each day to make a difference in the lives of patients and their families who live with rare neurological disorders," said John C. Jacobs, President and CEO. "We are pleased to receive this honor for the third year and grateful that Harmony team members experience the company as a welcoming, caring and collaborative environment that aims to make a positive impact in the patient community."

    Harmony's employees completed survey questions regarding the credibility and competence of management, workplace culture, diversity and inclusion, sense of camaraderie, ethical business practices and available resources. A summary of these ratings is available at: https://www.greatplacetowork.com/certified-company/7011504.

    About Harmony Biosciences 

    Harmony Biosciences is a commercial stage pharmaceutical company headquartered in Plymouth Meeting, PA. The company was established by Paragon Biosciences, LLC, and is focused on providing novel treatment options for people living with rare, neurological disorders who have unmet medical needs. For more information on Harmony Biosciences, please visit the company's website: www.harmonybiosciences.com.  

    About Great Place to Work®

    Great Place to Work® is the global authority on high-trust, high-performance workplace cultures. Through proprietary assessment tools, advisory services, and certification programs, including Best Workplaces lists and workplace reviews, Great Place to Work® provides the benchmarks, framework, and expertise needed to create, sustain, and recognize outstanding workplace cultures. In the United States, Great Place to Work® produces the annual Fortune "100 Best Companies to Work For®" list and a series of Great Place to Work® Best Workplaces lists, including lists for Millennials, Women, Diversity, Small and Medium Companies and over a half dozen different industry lists. 

     

    Harmony Biosciences Media Contact: 

    Nancy Leone 

    215-891-6046 

     

    Harmony Biosciences Investor Contact: 

    Lisa Caperelli 

    484-539-9736 

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/harmony-biosciences-certified-as-a-great-place-to-work-for-the-third-year-in-a-row-301237928.html

    SOURCE Harmony Biosciences

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  2. PLYMOUTH MEETING, Pa. and CHICAGO, Dec. 17, 2020 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony") (NASDAQ:HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced the Company will be added to the Russell 2000® and Russell 3000® Indexes effective after the U.S. market closes on Friday, December 18.

    "Inclusion in the Russell 2000® and Russell 3000® Indexes is an important milestone for Harmony," said John C. Jacobs, Harmony's President and Chief Executive Officer. "We believe it will enhance Harmony's visibility in the investment community and broaden our shareholder base."

    The Russell Indexes are a leading benchmark for institutional investors to track current and historical market performance. The Russell 3000® Index measures the performance of the largest 3,000 publicly traded companies in the U.S., representing the top 98% of the U.S. equity market. The Russell 2000® Index measures the performance of the 2,000 smallest-cap U.S. companies in the Russell 3000® Index.

    About Harmony Biosciences

    Harmony Biosciences is a commercial stage pharmaceutical company headquartered in Plymouth Meeting, PA and Chicago, IL. The company was established by Paragon Biosciences, LLC, and is focused on providing novel treatment options for people living with rare, neurological disorders who have unmet medical needs. For more information on Harmony Biosciences, please visit the company's website: www.harmonybiosciences.com.

    Forward Looking Statement

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding our product WAKIX®. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our commercialization efforts and strategy for WAKIX®; the rate and degree of market acceptance and clinical utility of WAKIX®, pitolisant in additional indications, if approved, and any other product candidates we may develop or acquire, if approved; our research and development plans, including our plans to explore the therapeutic potential of pitolisant in additional indications; our ongoing and planned clinical trials; our ability to expand the scope of our license agreement with Bioprojet; the availability of favorable insurance coverage and reimbursement for WAKIX®; the impact of the COVID-19 pandemic; the timing of and our ability to obtain regulatory approvals for pitolisant for other indications as well as any other product candidates; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; our ability to identify additional products or product candidates with significant commercial potential that are consistent with our commercial objectives; our commercialization, marketing and manufacturing capabilities and strategy; significant competition in our industry; our intellectual property position; loss or retirement of key members of management; failure to successfully execute our growth strategy, including any delays in our planned future growth; our failure to maintain effective internal controls; the impact of government laws and regulations; volatility and fluctuations in the price of our common stock; and the significant costs and required management time as a result of operating as a public company; the fact that the price of the company's common stock may be volatile and fluctuate substantially; significant costs and required management time as a result of operating as a public company. These and other important factors discussed under the caption "Risk Factors" in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the "SEC") on November 12, 2020, and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.

    Harmony Biosciences Media Contact:

    Nancy Leone

    215-891-6046

    Harmony Biosciences Investor Contact:

    Lisa Caperelli

    484-539-9736

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/harmony-biosciences-to-be-added-to-russell-2000-and-russell-3000-indexes-301194641.html

    SOURCE Harmony Biosciences

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  3. PLYMOUTH MEETING, Pa. and CHICAGO, Dec. 15, 2020 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony") (NASDAQ:HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced the first patient has been enrolled in a Phase 2 trial evaluating the safety and efficacy of pitolisant for the treatment of excessive daytime sleepiness (EDS) and other key symptoms in patients with Prader-Willi Syndrome (PWS).

    "We view pitolisant as a portfolio in a product opportunity and are taking a mechanism-based approach to drug development in managing its life cycle with the goal of expanding its clinical utility," said Harmony's Chief Medical Officer, Jeffrey Dayno, M.D. "We believe pitolisant could offer an important therapeutic benefit in people living with PWS based on preclinical models of the disorder, pitolisant's demonstrated efficacy in improving EDS in patients with narcolepsy, and anecdotal evidence in patients with PWS. We look forward to continuing our collaboration with the Foundation for Prader-Willi Research, the Prader-Willi Syndrome Association USA, and the patient and family community as we advance our development program in order to help address this unmet medical need."

    PWS is a genetic orphan/rare neurological disorder with many of the symptoms resulting from hypothalamic dysfunction. The hypothalamus is the part of the brain that controls both sleep-wake state stability and signals that mediate the balance between hunger and satiety. The hypothalamic dysfunction in patients with PWS results in two of the main symptoms of the disorder: EDS and hyperphagia (an abnormally increased appetite for and consumption of food). Other features include low muscle tone, short stature, behavioral problems and cognitive impairment. Approximately 15,000 to 20,000 people in the U.S. live with PWS, and over half of them experience EDS.

    "We support and encourage research that can potentially help reduce the symptom burden for children and adults living with PWS. We are grateful that Harmony is studying pitolisant in a clinical trial, which may bring us one step closer to finding an important therapeutic advancement," said John Walter, Chief Executive Officer, Foundation for Prader-Willi Research and Paige Rivard, Chief Executive Officer, Prader-Willi Syndrome Association USA in a joint statement.

    The Phase 2 clinical trial is a randomized, double-blind, placebo-controlled study designed to assess the safety and efficacy of pitolisant in patients with PWS ages 6-to-65. An estimated 60-70 patients will be enrolled at approximately 10 sites across the United States. Patients will be randomized to receive one of two doses of pitolisant or placebo for eight weeks of stable dosing following a three-week titration period. The trial's primary objective is to assess improvement in EDS as measured by the Multiple Sleep Latency Test. Topline results are anticipated in the first half of 2022. Patients who complete the trial will be eligible to participate in an open-label extension phase to assess the long-term safety and effectiveness of pitolisant. 

    "I have seen first-hand the debilitating effects this rare disease can have on patients with Prader-Willi Syndrome," said Dr. Daniel Glaze from Baylor College of Medicine and Texas Children's Hospital, and investigator in the Phase 2 clinical trial. "Excessive daytime sleepiness is more common in patients with PWS than previously appreciated and results in significant impact on daily functioning. In addition, EDS has not been studied in clinical trials to date in patients with PWS. I look forward to participating in this trial to assess the effect of pitolisant on EDS and other related symptoms."  

    Pitolisant is marketed as WAKIX® in the U.S. for the treatment of EDS or cataplexy in adult patients with narcolepsy.

    About WAKIX® (pitolisant) Tablets

    WAKIX, a first-in-class medication, is approved by the U.S. Food and Drug Administration for the treatment of excessive daytime sleepiness or cataplexy in adult patients with narcolepsy. WAKIX has been commercially available in the U.S. since Q4 2019. It was granted orphan drug designation for the treatment of narcolepsy in 2010. WAKIX is a selective histamine 3 (H₃) receptor antagonist/inverse agonist. The mechanism of action of WAKIX is unclear; however, its efficacy could be mediated through its activity at H₃ receptors, thereby increasing the synthesis and release of histamine, a wake promoting neurotransmitter. WAKIX was designed and developed by Bioprojet (France). Harmony has an exclusive license from Bioprojet to develop, manufacture and commercialize pitolisant in the United States.

    Important Safety Information

    WAKIX is contraindicated in patients with known hypersensitivity to pitolisant or any component of the formulation and in patients with severe hepatic impairment. WAKIX is extensively metabolized by the liver and there is a significant increase in WAKIX exposure in patients with moderate impairment.

    WAKIX prolongs the QT interval. Avoid use of WAKIX in patients with known QT prolongation or in combination with other drugs known to prolong the QT interval. Avoid use of WAKIX in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and the presence of congenital prolongation of the QT interval.

    The risk of QT prolongation may be greater in patients with hepatic or renal impairment due to higher concentrations of pitolisant; monitor these patients for increased QTc. Dosage modification is recommended in patients with moderate hepatic impairment and moderate or severe renal impairment. WAKIX is not recommended in patients with end-stage renal disease (ESRD).

    In the placebo-controlled clinical trials conducted in patients with narcolepsy with or without cataplexy, the most common adverse reactions (≥5% and twice placebo) for WAKIX were insomnia (6%), nausea (6%), and anxiety (5%). Other adverse reactions that occurred at ≥2% and more frequently than in patients treated with placebo included headache, upper respiratory infection, musculoskeletal pain, heart rate increased, hallucinations, irritability, abdominal pain, sleep disturbance, decreased appetite, cataplexy, dry mouth, and rash.

    Please see the Full Prescribing Information for WAKIX for more information.

    About Harmony Biosciences

    Harmony Biosciences is a commercial stage pharmaceutical company headquartered in Plymouth Meeting, PA and Chicago, IL. The company was established by Paragon Biosciences, LLC, and is focused on providing novel treatment options for people living with rare, neurological disorders who have unmet medical needs. For more information on Harmony Biosciences, please visit the company's website: www.harmonybiosciences.com.

    Forward Looking Statement

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding our product WAKIX®. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our commercialization efforts and strategy for WAKIX®; the rate and degree of market acceptance and clinical utility of WAKIX®, pitolisant in additional indications, if approved, and any other product candidates we may develop or acquire, if approved; our research and development plans, including our plans to explore the therapeutic potential of pitolisant in additional indications; our ongoing and planned clinical trials; our ability to expand the scope of our license agreement with Bioprojet; the availability of favorable insurance coverage and reimbursement for WAKIX®; the impact of the COVID-19 pandemic; the timing of and our ability to obtain regulatory approvals for pitolisant for other indications as well as any other product candidates; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; our ability to identify additional products or product candidates with significant commercial potential that are consistent with our commercial objectives; our commercialization, marketing and manufacturing capabilities and strategy; significant competition in our industry; our intellectual property position; loss or retirement of key members of management; failure to successfully execute our growth strategy, including any delays in our planned future growth; our failure to maintain effective internal controls; the impact of government laws and regulations; volatility and fluctuations in the price of our common stock; and the significant costs and required management time as a result of operating as a public company; the fact that the price of the company's common stock may be volatile and fluctuate substantially; significant costs and required management time as a result of operating as a public company. These and other important factors discussed under the caption "Risk Factors" in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the "SEC") on November 12, 2020, and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.

    Harmony Biosciences Media Contact:

    Nancy Leone

    215-891-6046

    Harmony Biosciences Investor Contact:

    Lisa Caperelli

    484-539-9736

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/harmony-biosciences-enrolls-first-patient-in-phase-2-trial-evaluating-pitolisant-for-excessive-daytime-sleepiness-in-patients-with-prader-willi-syndrome-301192466.html

    SOURCE Harmony Biosciences

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  4. WAKIX®(pitolisant) Total Revenue of $45.6 Million for Third Quarter of 2020

    Differentiated Product Profile Aligns with Unmet Medical Need

    On Track to Initiate Phase 2 Trial in Patients with Prader-Willi Syndrome by Year End

    Conference Call and Webcast to be held today at 8:30 a.m. Eastern Time

    PLYMOUTH MEETING, Penn. and CHICAGO, Nov. 12, 2020 (GLOBE NEWSWIRE) -- Harmony Biosciences Holdings, Inc. ("Harmony") (NASDAQ:HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today reported financial results for the quarter ended September 30, 2020, and provided recent business updates.

    "Harmony experienced another productive…

    WAKIX® (pitolisant) Total Revenue of $45.6 Million for Third Quarter of 2020

    Differentiated Product Profile Aligns with Unmet Medical Need

    On Track to Initiate Phase 2 Trial in Patients with Prader-Willi Syndrome by Year End

    Conference Call and Webcast to be held today at 8:30 a.m. Eastern Time

    PLYMOUTH MEETING, Penn. and CHICAGO, Nov. 12, 2020 (GLOBE NEWSWIRE) -- Harmony Biosciences Holdings, Inc. ("Harmony") (NASDAQ:HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today reported financial results for the quarter ended September 30, 2020, and provided recent business updates.

    "Harmony experienced another productive quarter with continued WAKIX revenue growth and meaningful advancement of our key clinical programs," commented John C. Jacobs, Harmony's President and Chief Executive Officer. "WAKIX sales continued to increase on a quarterly basis through the COVID-19 pandemic, reflecting the unmet medical need for a first-in-class medication with a novel mechanism of action. The recent approval of the cataplexy indication for WAKIX expanded the label in narcolepsy which, along with WAKIX being the only FDA approved product for narcolepsy that is not scheduled as a controlled substance, provides additional commercial opportunity. With a robust cash position stemming from our recent IPO, we have the financial resources to continue supporting our commercialization efforts for WAKIX, advance our clinical programs, and to pursue the acquisition of additional assets that would be complimentary to our existing commercial footprint and core areas of expertise."

    Third Quarter 2020 Financial Highlights:

    • Net product revenue was $45.6 million for the third quarter ended September 30, 2020.
    • Research and development expenses were $4.2 million for the third quarter of 2020 compared with $4.3 million for the third quarter of 2019.
    • Sales and marketing expenses were $12.6 million for the third quarter of 2020 compared with $12.9 million for the third quarter of 2019.
    • General and administrative expenses were $10.5 million for the third quarter of 2020 compared with $12.6 million for the third quarter of 2019.
    • Net income was $1.9 million for the third quarter of 2020 compared with a net loss of $31.9 million for the third quarter of 2019.
    • Cash and cash equivalents as of September 30, 2020 was $221.7 million.

    Harmony Founder and Chairman, and Paragon Biosciences Chairman and CEO, Jeff Aronin, commented, "From the time we founded Harmony, to its FDA approval of WAKIX, and recent approval of a second indication, the team has worked relentlessly to build a company that has contributed to scientific innovation in neurological disorders. We are pleased with Harmony's continued progress to address unmet medical needs, including the benefits that WAKIX has provided for people living with narcolepsy."  

    Recent Program Highlights and Updates:

    WAKIX® (pitolisant) in Narcolepsy

    • On October 13, 2020, the U.S. Food and Drug Administration (FDA) approved WAKIX for the treatment of cataplexy in adult patients with narcolepsy. This approval expands the label for WAKIX and broadens its clinical utility for healthcare professionals managing adult patients living with narcolepsy. WAKIX is the first and only treatment approved by the FDA for people with excessive daytime sleepiness (EDS) or cataplexy associated with narcolepsy that is not scheduled as a controlled substance by the U.S. Drug Enforcement Administration (DEA).

    Pitolisant in Patients with Prader-Willi Syndrome (PWS) and Myotonic Dystrophy (DM)

    • PWS and DM are rare, genetic multi-system diseases for which there are no approved treatments for many of the symptoms, resulting in significant unmet medical needs.

      • For PWS, clinical sites are being activated to conduct a Phase 2 randomized, double-blind, placebo-controlled trial to assess the safety and efficacy of pitolisant in patients with PWS, with the primary endpoint being EDS. We are on-track to initiate this trial this year.

      • For DM, we are on-track to submit an IND by year end with the plan to initiate a Phase 2 clinical trial in the first half of 2021.

    Recent Business Updates:

    • On August 21, 2020 we successfully completed our upsized IPO of 6,151,162 shares of common stock at a public offering price of $24.00 per share, including an exercise in full of the underwriters' option to purchase additional shares. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses, were $147.6 million.
    • In November, we expanded the depth and breadth of our Board of Directors with the addition of Mark Graf and Eric Motley.

    Conference Call Today at 8:30 a.m. ET

    We are hosting our third quarter 2020 financial results conference call and webcast today beginning at 8:30 a.m. Eastern Time. The live and replayed webcast of the call will be available on the investor page of our website at https://ir.harmonybiosciences.com/. To participate in the live call by phone, dial (833) 614-1471 (domestic) or +1 (914) 987-7209 (international), and reference passcode 7489154. A replay will be accessible until November 19, 2020 by dialing (855) 859-2056 (domestic) or +1 (404) 537-3406 (international).

    About WAKIX® (pitolisant) Tablets

    WAKIX, a first-in-class medication, is approved by the U.S. Food and Drug Administration for the treatment of excessive daytime sleepiness or cataplexy in adult patients with narcolepsy and has been commercially available in the U.S. since Q4 2019. It was granted orphan drug designation for the treatment of narcolepsy in 2010. WAKIX is a selective histamine 3 (H₃) receptor antagonist/inverse agonist. Although, the mechanism of action of WAKIX is unclear, its efficacy could be mediated through its activity at H₃ receptors, thereby increasing the synthesis and release of histamine, a wake promoting neurotransmitter. WAKIX was designed and developed by Bioprojet Société Civile de Recherche (Bioprojet). Harmony has an exclusive license from Bioprojet to develop, manufacture and commercialize pitolisant in the United States.

    Indications and Usage

    WAKIX is indicated for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy.

    Important Safety Information

    Contraindications

    WAKIX is contraindicated in patients with known hypersensitivity to pitolisant or any component of the formulation. Anaphylaxis has been reported. WAKIX is also contraindicated in patients with severe hepatic impairment.

    Warnings and Precautions

    WAKIX prolongs the QT interval; avoid use of WAKIX in patients with known QT prolongation or in combination with other drugs known to prolong the QT interval. Avoid use in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and the presence of congenital prolongation of the QT interval. 

    The risk of QT prolongation may be greater in patients with hepatic or renal impairment due to higher concentrations of pitolisant; monitor these patients for increased QTc. Dosage modification is recommended in patients with moderate hepatic impairment and moderate or severe renal impairment (see full prescribing information). WAKIX is not recommended in patients with end-stage renal disease (ESRD).

    Adverse Reactions

    In the placebo-controlled clinical trials conducted in patients with narcolepsy with or without cataplexy, the most common adverse reactions (≥5% and twice placebo) for WAKIX were insomnia (6%), nausea (6%), and anxiety (5%). Other adverse reactions that occurred at ≥2% and more frequently than in patients treated with placebo included headache, upper respiratory infection, musculoskeletal pain, heart rate increased, hallucinations, irritability, abdominal pain, sleep disturbance, decreased appetite, cataplexy, dry mouth, and rash.

    Drug Interactions

    Concomitant administration of WAKIX with strong CYP2D6 inhibitors increases pitolisant exposure by 2.2-fold. Reduce the dose of WAKIX by half. 

    Concomitant use of WAKIX with strong CYP3A4 inducers decreases exposure of pitolisant by 50%. Dosage adjustments may be required (see full prescribing information). 

    H1 receptor antagonists that cross the blood-brain barrier may reduce the effectiveness of WAKIX. Patients should avoid centrally acting H1 receptor antagonists. 

    WAKIX is a borderline/weak inducer of CYP3A4. Therefore, reduced effectiveness of sensitive CYP3A4 substrates may occur when used concomitantly with WAKIX. The effectiveness of hormonal contraceptives may be reduced when used with WAKIX and effectiveness may be reduced for 21 days after discontinuation of therapy.

    Use in Specific Populations

    WAKIX may reduce the effectiveness of hormonal contraceptives. Patients using hormonal contraception should be advised to use an alternative non-hormonal contraceptive method during treatment with WAKIX and for at least 21 days after discontinuing treatment. 

    There is a pregnancy exposure registry that monitors pregnancy outcomes in women who are exposed to WAKIX during pregnancy. Patients should be encouraged to enroll in the WAKIX pregnancy registry if they become pregnant. To enroll or obtain information from the registry, patients can call 1-800-833-7460.

    The safety and effectiveness of WAKIX have not been established in patients less than 18 years of age. 

    WAKIX is extensively metabolized by the liver. WAKIX is contraindicated in patients with severe hepatic impairment. Dosage adjustment is required in patients with moderate hepatic impairment.

    WAKIX is not recommended in patients with end-stage renal disease. Dosage adjustment of WAKIX is recommended in patients with moderate or severe renal impairment. 

    Dosage reduction is recommended in patients known to be poor CYP2D6 metabolizers; these patients have higher concentrations of WAKIX than normal CYP2D6 metabolizers.

    Please see the Full Prescribing Information for WAKIX for more information.

    To report suspected adverse reactions, contact Harmony Biosciences at 1-800-833-7460 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    About Harmony Biosciences

    Harmony Biosciences is a commercial stage pharmaceutical company headquartered in Plymouth Meeting, PA and Chicago, IL. The company was established by Paragon Biosciences, LLC, and is focused on providing novel treatment options for people living with rare, neurological disorders who have unmet medical needs. For more information on Harmony Biosciences, please visit the company's website: www.harmonybiosciences.com.

    Forward Looking Statement

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding our product WAKIX®. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our commercialization efforts and strategy for WAKIX®; the rate and degree of market acceptance and clinical utility of WAKIX®, pitolisant in additional indications, if approved, and any other product candidates we may develop or acquire, if approved; our research and development plans, including our plans to explore the therapeutic potential of pitolisant in additional indications; our ongoing and planned clinical trials; our ability to expand the scope of our license agreement with Bioprojet; the availability of favorable insurance coverage and reimbursement for WAKIX®; the impact of the COVID-19 pandemic; the timing of and our ability to obtain regulatory approvals for pitolisant for other indications as well as any other product candidates; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; our ability to identify additional products or product candidates with significant commercial potential that are consistent with our commercial objectives; our commercialization, marketing and manufacturing capabilities and strategy; significant competition in our industry; our intellectual property position; loss or retirement of key members of management; failure to successfully execute our growth strategy, including any delays in our planned future growth; our failure to maintain effective internal controls; the impact of government laws and regulations; volatility and fluctuations in the price of our common stock; and the significant costs and required management time as a result of operating as a public company; the fact that the price of the company's common stock may be volatile and fluctuate substantially; significant costs and required management time as a result of operating as a public company. These and other important factors discussed under the caption "Risk Factors" in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the "SEC") on November 12, 2020, and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.

    HARMONY BIOSCIENCES HOLDINGS, INC.

    UNAUDITED CONDENSED CONSOLIDATED

    STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)

    (In thousands except share and per share data)

     Three Months Ended September 30,Nine Months Ended September 30,
     2020201920202019
    Net product revenues$45,609 $ $103,454 $ 
    Cost of product sold 7,890    17,820   
    Gross profit 37,719    85,634   
    Operating expenses:    
    Research and development 4,230  4,336  11,829  62,319 
    Sales and marketing 12,601  12,908  38,297  27,477 
    General and administrative 10,508  12,560  26,280  22,415 
    Total operating expenses 27,339  29,804  76,406  112,211 
    Operating income (loss) 10,380  (29,804) 9,228  (112,211)
    Loss on debt extinguishment     (22,639)  
    Other expense, net (1,525)   (3,071)  
    Interest expense, net (6,946) (2,095) (20,254) (3,326)
    Income (loss) before income taxes 1,909  (31,899) (36,736) (115,537)
    Income taxes        
    Net income (loss) and comprehensive loss$1,909 $(31,899)$(36,736)$(115,537)
    Accumulation of dividends on preferred stock (6,013) (9,027) (26,904) (25,656)
    Net loss available to common stockholders$(4,104)$(40,926)$(63,640)$(141,193)
    NET LOSS PER SHARE:    
    Basic$(0.14)$(5.26)$(4.15)$(18.15)
    Diluted$(0.14)$(5.26)$(4.15)$(18.15)
    Weighted average number of shares of common stock - basic 30,212,959  7,777,100  15,324,362  7,777,100 
    Weighted average number of shares of common stock - diluted 30,212,959  7,777,100  15,324,362  7,777,100 
         

    HARMONY BIOSCIENCES HOLDINGS, INC.

    UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands except share and per share data)

     September 30, 2020December 31, 2019
    ASSETS  
    CURRENT ASSETS:  
    Cash and cash equivalents$221,740 $24,457 
    Trade receivables, net 16,326  4,255 
    Inventory, net 2,311  1,088 
    Prepaid expenses 4,240  1,436 
    Other current assets 5,625  261 
    Total current assets 250,242  31,497 
    NONCURRENT ASSETS:  
    Property and equipment, net 1,038  1,330 
    Restricted cash 750  750 
    Intangible asset, net 66,625  72,185 
    Other noncurrent assets 1,418  941 
    Total noncurrent assets 69,831  75,206 
    TOTAL ASSETS$320,073 $106,703 
    LIABILITIES, CONVERTIBLE PREFERRED STOCK, AND STOCKHOLDERS' EQUITY (DEFICIT)  
    CURRENT LIABILITIES:  
    Trade payables$9,347 $6,360 
    Accrued compensation 5,243  7,917 
    Accrued expenses 17,200  5,500 
    Other current liabilities   115 
    Total current liabilities 31,790  19,892 
    NONCURRENT LIABILITIES:  
    Deferred rent 305  287 
    Long term debt, net 192,858  97,946 
    Other noncurrent liabilities 571  163 
    Total noncurrent liabilities 193,734  98,396 
    TOTAL LIABILITIES 225,524  118,288 
    COMMITMENTS AND CONTINGENCIES (Note 9)  
    CONVERTIBLE PREFERRED STOCK  
    Convertible preferred stock, net of placement costs  
    Series A convertible preferred stock - $1.00 stated value; 0 shares and 286,000,000 shares authorized at September 30, 2020 and December 31, 2019, respectively; 0 shares and 285,000,000 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively   348,203 
    Series B convertible preferred stock - $1.25 stated value; 0 shares and 8,030,000 shares authorized at September 30, 2020 and December 31, 2019, respectively; 0 shares and 8,000,000 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively   12,023 
    Series C convertible preferred stock - $1.96 stated value; 0 shares and 25,600,000 shares authorized at September 30, 2020 and December 31, 2019, respectively; 0 shares and 25,510,205 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively   51,051 
    STOCKHOLDERS' EQUITY (DEFICIT):    
    Preferred stock - $0.00001 par value; 10,000,000 shares and 0 shares authorized at September 30, 2020 and December 31, 2019, respectively; 0 shares issued and outstanding at September 30, 2020 and December 31, 2019    
    Common stock - $0.00001 par value; 500,000,000 shares and 423,630,000 shares authorized at September 30, 2020 and December 31, 2019, respectively; 56,888,625 shares and 7,787,470 issued and outstanding at September 30, 2020 and December 31, 2019, respectively 1   
    Additional paid in capital 582,535   
    Accumulated deficit (487,987) (422,862)
    TOTAL STOCKHOLDERS' EQUITY (DEFICIT) 94,549  (422,862)
    TOTAL LIABILITIES, CONVERTIBLE PREFERRED STOCK, AND STOCKHOLDERS' EQUITY (DEFICIT)$320,073 $106,703 
       

    Harmony Biosciences Investor Contact:

    Lisa Caperelli

    610-608-0215



    Harmony Biosciences Media Contact:

    Nancy Leone

    215-891-6046

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  5. PLYMOUTH MEETING, Pa. and CHICAGO, Nov. 11, 2020 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony") (NASDAQ:HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced the appointment of Mark Graf and Eric Motley to the Company's Board of Directors. Mark Graf is an executive with deep financial expertise as well as an experienced board member with a strong background in corporate governance. Eric Motley is an expert in human capital development who has advised previous government, not-for-profit and private sector organizations as an organizational development executive, in addition to his governance…

    PLYMOUTH MEETING, Pa. and CHICAGO, Nov. 11, 2020 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony") (NASDAQ:HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced the appointment of Mark Graf and Eric Motley to the Company's Board of Directors. Mark Graf is an executive with deep financial expertise as well as an experienced board member with a strong background in corporate governance. Eric Motley is an expert in human capital development who has advised previous government, not-for-profit and private sector organizations as an organizational development executive, in addition to his governance experience on corporate and philanthropic boards.

    "The wealth of financial, management and governance expertise Mark and Eric bring adds to the depth and breadth of Harmony's board," said Jeff Aronin, Harmony Founder and Chairman, and Paragon Biosciences Chairman and CEO. "Their insights will be invaluable to help oversee the strategic growth of Harmony as a public company. We are honored to have them join our Board."

    Before retiring in 2019, Mark Graf spent over eight years as the Chief Financial Officer of Discover Financial Services and was a core member of the firm's Executive Committee. In addition to all aspects of financial management, he was responsible for managing the company's $110 billion balance sheet, corporate development and investor relations. He was named the #1 Chief Financial Officer in the consumer financial services sector by the readers of Institutional Investor magazine every year from 2014 through 2019. 

    Prior to joining Discover, Mark spent five years in the private equity realm. Most recently, he was an Investment Advisor at Aquiline Capital Partners, a private equity firm specializing in investments in financial services and financial technology enterprises. Prior to Aquiline, he briefly served as a Partner at Barrett Ellman Stoddard Capital Partners and he served as Chief Financial Officer of Fifth Third Bancorp from 2004 to 2006 and was its Corporate Treasurer from 2001 to 2004. He also served in various roles at AmSouth Bancorporation from 1994 to 2001.

    Mark brings a strong background in corporate governance and qualifies as an audit committee financial expert. Mark holds a Bachelor of Science in Economics from the University of Pennsylvania's Wharton School.

    Eric Motley is a senior management, talent, and organizational development executive with 20 years of experience assisting government, not-for-profit, and private sector organizations with building high-performing teams. Currently, Eric is an Executive Vice President and the Corporate Secretary at the Aspen Institute, a global, non-partisan public policy organization, based in Washington, DC. He previously served as Director of the Henry Crown Fellowship Program, recognized by many as one of the most prestigious leadership development programs in the United States. 

    Eric served at the White House for over four years, eventually as a Special Assistant to President George W. Bush, working in the Office of Presidential Personnel, where he managed the appointment process for over 1,200 presidentially appointed advisory board and commission positions.

    Eric also has strong governance experience through his work with corporate and philanthropic boards. He earned his undergraduate degree from Samford University, and received his master and doctorate degrees at the University of St. Andrews in Scotland.

    About Harmony Biosciences

    Harmony Biosciences is a commercial stage pharmaceutical company headquartered in Plymouth Meeting, PA and Chicago, IL. The company was established by Paragon Biosciences, LLC, and is focused on providing novel treatment options for people living with rare, neurological disorders who have unmet medical needs. For more information on Harmony Biosciences, please visit the company's website: www.harmonybiosciences.com.

    Harmony Biosciences Media Contact:

    Nancy Leone

    215-891-6046

    Harmony Biosciences Investor Contact:

    Lisa Caperelli

    484-539-9736

     

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    SOURCE Harmony Biosciences

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