HRMY Harmony Biosciences Holdings Inc.

27.72
+0.31  (+1%)
Previous Close 27.41
Open 27.5
52 Week Low 26.51
52 Week High 52.74
Market Cap $1,577,057,494
Shares 56,892,406
Float 17,886,816
Enterprise Value $1,533,004,785
Volume 134,731
Av. Daily Volume 159,489
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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., April 27, 2021 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("the Company") (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 that data from three analyses of the clinical development program for WAKIX® (pitolisant), a medication approved for the treatment of excessive daytime sleepiness or cataplexy in adults with narcolepsy, will be presented at the 2021 American Psychiatric Association (APA) Annual Meeting, to be held virtually May 1-3. Two of the three poster presentations feature analyses of efficacy and safety data from the clinical development program…

    PLYMOUTH MEETING, Pa., April 27, 2021 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("the Company") (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 that data from three analyses of the clinical development program for WAKIX® (pitolisant), a medication approved for the treatment of excessive daytime sleepiness or cataplexy in adults with narcolepsy, will be presented at the 2021 American Psychiatric Association (APA) Annual Meeting, to be held virtually May 1-3. Two of the three poster presentations feature analyses of efficacy and safety data from the clinical development program for WAKIX in adult patients with narcolepsy and the third is based on a post-hoc analysis that evaluated the time to onset of clinical response for WAKIX.

    "Both excessive daytime sleepiness and cataplexy can have a significant impact on a person's daily functioning, which may greatly affect their social, emotional and psychological well-being," said Harmony's Chief Medical Officer, Jeffrey Dayno, M.D. "Given this, and the fact that sleep disorders are co-morbid with several different psychiatric disorders, we are pleased to share these data for WAKIX with the psychiatry and mental health professional communities for the first time."

    The data to be presented by Harmony will be available from 11 a.m. to 5:30 p.m. EDT on May 1-3, and includes:

    • Efficacy and Safety of Pitolisant in the Treatment of Excessive Daytime Sleepiness in Adult Patients With Narcolepsy: A Review of Clinical Trials (Poster 4463). L Krahn, C Davis, J-C Schwartz, J Dayno.
      • Analysis of results from HARMONY 1 and HARMONY 1bis, two pivotal randomized, placebo-controlled, 8-week trials that assessed the efficacy and safety of pitolisant for the treatment of excessive daytime sleepiness in adults with narcolepsy.
    • Efficacy of Pitolisant, a Selective Histamine 3 (H3)-Receptor Antagonist/Inverse Agonist, in the Treatment of Cataplexy in Patients With Narcolepsy (Poster 4460). M Thorpy, J-C Schwartz, C Caussé, J Dayno.
      • A review of results from HARMONY 1, HARMONY 1bis, HARMONY CTP and HARMONY 3 Phase 3 clinical trials, which assessed safety and efficacy of pitolisant for the treatment of cataplexy in adults with narcolepsy.
    • Time Course of Improvement in Excessive Daytime Sleepiness and Cataplexy During Treatment with Pitolisant in Patients with Narcolepsy (Poster 4469). C Davis, J Dayno, B Vaughn, Y Dauvilliers, J-C Schwartz.
      • Analysis evaluating the time-to-response to treatment with pitolisant for excessive daytime sleepiness and cataplexy from the HARMONY-1 and HARMONY-CTP randomized, placebo-controlled trials in adults 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 Narcolepsy  

    Narcolepsy is a rare, chronic, debilitating neurological disorder of sleep-wake state instability that impacts approximately 165,000 Americans and is primarily characterized by excessive daytime sleepiness (EDS) and cataplexy – its two cardinal symptoms – along with other manifestations of REM sleep dysregulation, which intrude into wakefulness. EDS is the inability to stay awake and alert during the day and is the symptom that is present in all people living with narcolepsy. In most patients, narcolepsy is caused by the loss of hypocretin, a neuropeptide in the brain that supports sleep-wake state stability. This disorder affects men and women equally, with typical symptom onset in adolescence or young adulthood; however, it can take up to a decade to be properly diagnosed. 

    About Harmony Biosciences 

    Harmony Biosciences is a pharmaceutical company headquartered in Plymouth Meeting, PA. The company was established by Paragon Biosciences, LLC, with a vision to provide 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 Harmony'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 Annual Report on Form 10-K filed with the Securities and Exchange Commission (the "SEC") on March 25, 2021, 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-present-wakix-pitolisant-efficacy-and-safety-data-at-upcoming-2021-american-psychiatric-association-annual-meeting-301276982.html

    SOURCE Harmony Biosciences

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  2. PLYMOUTH MEETING, Pa., April 27, 2021 /PRNewswire/ -- Harmony Biosciences Holdings, Inc. ("Harmony" or the "Company") (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 that it will issue a press release on the Company's first quarter 2021 financial results on Tuesday, May 11, 2021 at 8:00 a.m. ET. Following the release, Harmony will conduct a conference call and live webcast on the same day, at 8:30 a.m. ET.

    To participate in the call, please dial (833) 614-1471 (domestic) or +1 (914) 987-7209 (international), and reference passcode 2269379. It is recommended that you dial in at least 10 minutes prior to the call.

    The live and replayed webcast of the call will be available on the investor page of our website at https://ir.harmonybiosciences.com/.

    A replay of the call will be available within 24 hours by dialing (855) 859-2056 (domestic) or +1 (404) 537-3406 (international) and entering conference ID: 2269379. The replay will be available until May 18, 2021.

    About Harmony Biosciences

    Harmony Biosciences is a pharmaceutical company headquartered in Plymouth Meeting, PA. The company was established by Paragon Biosciences, LLC, with a vision to provide 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 Investor Contact:

    Lisa Caperelli

    610-608-0215

    Harmony Biosciences Media Contact:

    Nancy Leone

    215-891-6046

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/harmony-biosciences-announces-date-of-first-quarter-2021-financial-results-301277200.html

    SOURCE Harmony Biosciences

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  3. PLYMOUTH MEETING, Pa., April 12, 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, today announced that results from two analyses from the clinical development program for WAKIX® (pitolisant) will be presented at the 2021 American Academy of Neurology (AAN) Annual Meeting, to be held virtually April 17-22. One of the poster presentations is based on a post-hoc analysis that evaluated the time-to-onset of clinical response for WAKIX and the second poster is based on a pooled analysis of the cardiovascular safety data from the clinical development…

    PLYMOUTH MEETING, Pa., April 12, 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, today announced that results from two analyses from the clinical development program for WAKIX® (pitolisant) will be presented at the 2021 American Academy of Neurology (AAN) Annual Meeting, to be held virtually April 17-22. One of the poster presentations is based on a post-hoc analysis that evaluated the time-to-onset of clinical response for WAKIX and the second poster is based on a pooled analysis of the cardiovascular safety data from the clinical development program for WAKIX in adult patients with narcolepsy.

    "These analyses further characterize the efficacy and safety profile of WAKIX and its broad clinical utility for the treatment of excessive daytime sleepiness or cataplexy in adult patients with narcolepsy," said Harmony's Chief Medical Officer, Jeffrey Dayno, M.D. "We look forward to sharing these data and the results of these analyses with both the neurology and narcolepsy communities."

    The data that will be presented by Harmony will be available from 7 a.m.-5 p.m. EDT on April 17-22, and include:

    • Time to Onset of Clinical Response During Treatment with Pitolisant (P26.015). C Davis, J Dayno, B Vaughn, Y Dauvilliers.
      • Analysis evaluating the time-to-onset of clinical response during treatment with pitolisant for excessive daytime sleepiness and cataplexy from the HARMONY-1 and HARMONY-CTP randomized, controlled trials in adults with narcolepsy.
    • Cardiac Safety Profile of Pitolisant in Patients with Narcolepsy (P26.016). W Winter, S Wanaski, A Patroneva, J Dayno.
      • Results from pooled analysis of two randomized, placebo-controlled seven-or eight-week studies and from a 12-month, open-label study evaluating the cardiac safety profile of pitolisant in adults with narcolepsy from the clinical development program.

    The abstracts can be viewed on the AAN website here and here.

    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 Narcolepsy

    Narcolepsy is a rare, chronic, debilitating neurological disorder of sleep-wake state instability that impacts approximately 165,000 Americans and is primarily characterized by excessive daytime sleepiness (EDS) and cataplexy – its two cardinal symptoms – along with other manifestations of REM sleep dysregulation, which intrude into wakefulness. EDS is the inability to stay awake and alert during the day and is the symptom that is present in all people living with narcolepsy. In most patients, narcolepsy is caused by the loss of hypocretin, a neuropeptide in the brain that supports sleep-wake state stability. This disorder affects men and women equally, with typical symptom onset in adolescence or young adulthood; however, it can take up to a decade to be properly diagnosed. 

    About Harmony Bioscience

    Harmony Biosciences is a pharmaceutical company headquartered in Plymouth Meeting, PA. The company was established by Paragon Biosciences, LLC, with a vision to provide 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 Harmony'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 Annual Report on Form 10-K filed with the Securities and Exchange Commission (the "SEC") on March 25, 2021, 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-present-wakix-pitolisant-data-at-the-2021-aan-annual-meeting-301266363.html

    SOURCE Harmony Biosciences

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  4. PLYMOUTH MEETING, Pa., April 7, 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, today announced the launch of a new grant program, Progress at the Heart, to accelerate programs and solutions that address inequity in access to diagnosis, treatment, and care in the rare disease and sleep disorder community.

    Many people from underrepresented racial, ethnic, or other minority groups often face an even greater disparity in access to care, particularly given underrepresentation in research and clinical trials. In recognition of World Health Day and National Minority Health Month this April, Progress at the Heart seeks community- and education-based solutions and grant applications are currently being accepted. Up to $125,000 in grants will be awarded by September 2021 in an effort to help achieve greater equality of care within the sleep disorder community.

    "Progress at the Heart is a natural extension of our grant programs and supports our mission to address the needs of those living with sleep disorders or rare diseases who experience sleep disruption and problems related to impaired wakefulness," said Cate McCanless, Harmony's Senior Vice President, Corporate Affairs and Policy. "Language barriers, real or perceived discrimination and bias, lack of access to resources and many more factors can contribute to the overall disparities experienced by racial, ethnic and other underrepresented minorities related to sleep health and sleep disorder diagnosis and treatment. We believe that through programs funded by Progress at the Heart grants, we will be able to recognize, realize and replicate effective interventions that address these disparities in the management of patients with sleep disorders, which, in turn, could reduce overall health disparities and improve quality of life for so many people."

    Harmony is accepting two rounds of grant applications in 2021 from April 7May 31 and from June 1August 20 which will be reviewed by a cross-functional team of Harmony employees. Grants will be awarded to applicants by the end of June and September 2021, respectively. For more information, please visit www.harmonybiosciences.com/grant-programs/progress-at-the-heart and submit grant applications to .

    About Harmony Biosciences 

    Harmony Biosciences is a pharmaceutical company headquartered in Plymouth Meeting, PA. The company was established by Paragon Biosciences, LLC, with a vision to provide 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 

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/harmony-biosciences-launches-grant-program-to-address-inequities-in-the-delivery-of-healthcare-in-patients-with-sleep-disorders-301263519.html

    SOURCE Harmony Biosciences

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  5. WAKIX®(pitolisant) Total Revenue of $160 Million for Full-Year 2020; $56 Million for Fourth Quarter 2020

    Clinical Utility of WAKIX was Expanded with Additional Approval for Treatment of Cataplexy in Adults with Narcolepsy

    Enrollment Continues in Phase 2 Trial of Patients with Prader-Willi Syndrome

    On Track to Initiate Two Additional Clinical Trials with Pitolisant in 2021

    Conference Call and Webcast to be Held Today at 8:30 a.m. ET

    PLYMOUTH MEETING, Pa., March 25, 2021 (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…

    WAKIX® (pitolisant) Total Revenue of $160 Million for Full-Year 2020; $56 Million for Fourth Quarter 2020

    Clinical Utility of WAKIX was Expanded with Additional Approval for Treatment of Cataplexy in Adults with Narcolepsy

    Enrollment Continues in Phase 2 Trial of Patients with Prader-Willi Syndrome

    On Track to Initiate Two Additional Clinical Trials with Pitolisant in 2021

    Conference Call and Webcast to be Held Today at 8:30 a.m. ET

    PLYMOUTH MEETING, Pa., March 25, 2021 (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 its financial results and business updates for the fourth quarter and full year ended December 31, 2020.

    2020 Financial and Business Highlights:

    • Net product revenue of $56.3 million for the fourth quarter ended December 31, 2020; Full-year net product revenue of $159.7 million;
    • U.S. Food and Drug Administration (FDA) approved expanded use of WAKIX for the treatment of cataplexy in adults with narcolepsy;
    • Enrolled first patient in Phase 2 clinical trial of WAKIX for the treatment of excessive daytime sleepiness (EDS) in patients with Prader-Willi Syndrome (PWS);
    • Completed upsized initial public offering of 6.15 million shares at a price of $24.00 per share on August 21, 2020 for gross proceeds of $147.6 million; and
    • Added to the Russell 2000® Index and Russell 3000® Index.

    "Harmony achieved many milestones during 2020 and has entered 2021 well positioned to advance our strategic objectives," stated John C. Jacobs, President and Chief Executive Officer of Harmony Biosciences. "Key to our success was the closing of our initial public offering in August 2020 and the listing of our common stock on the Nasdaq Global Market. These events elevated Harmony's visibility among investors and provided the financial resources that we believe will allow us to continue to support our commercialization efforts for WAKIX, advance our clinical programs, and pursue the acquisition of additional assets that would be complementary to our existing commercial footprint and core areas of expertise."

    Mr. Jacobs added, "With FDA approval of the cataplexy indication for WAKIX and despite the COVID-19 pandemic, WAKIX sales posted double-digit, quarter-over-quarter growth. I am grateful to our employees who met the challenge of achieving these goals during a disruptive global pandemic. Looking ahead, our Phase 2 trial in patients with Prader-Willi Syndrome is actively enrolling patients and our clinical team has made good progress toward the initiation of two additional clinical trials, one in patients with myotonic dystrophy and another in pediatric narcolepsy patients."

    Fourth Quarter 2020 Financial Results

    For the three-month period ended December 31, 2020, Harmony reported net product revenue of $56.3 million, compared to $6.0 million for the same three-month period in 2019. The increase was primarily due to growing sales of WAKIX, which first became commercially available in November 2019, and the label expansion to include cataplexy in patients with narcolepsy that occurred on October 13, 2020.

    For the three-month period ended December 31, 2020, Harmony reported net loss of $0.2 million, or $0.00 per diluted share on a U.S. generally accepted accounting principles (GAAP) basis.

    For the three-month period ended December 31, 2020 and 2019, a comparison of total operating expenses is not meaningful and not included in this commentary as WAKIX did not become commercially available for the treatment of EDS in adult patients with narcolepsy until November 2019.

    Full Year 2020 Financial Results

    For the twelve-month period ended December 31, 2020, net product revenue grew to $159.7 million, compared to $6.0 million during the same twelve-month period in 2019. The increase was primarily due to growing sales of WAKIX following the drug's initial FDA approval in November 2019 as a treatment for EDS in adult patients with narcolepsy and the label expansion in October 2020 to include cataplexy in adult patients with narcolepsy.

    For the twelve-month period ended December 31, 2020, total operating expenses were $115.0 million compared to $150.3 million for the same twelve-month period in 2019. The decrease was primarily driven by a decrease in R&D expenses related to payment of a $50 million milestone to Bioprojet, partially offset by an increase in sales and marketing and general and administrative expenses related to the commercial launch of WAKIX.

    For the twelve-month period ended December 31, 2020, Harmony reported a net loss of $36.9 million, or $2.48 per diluted share on a GAAP basis. For the same period, non-GAAP adjusted net income was $32.5 million, and after deducting $26.9 million of accumulation of yield on preferred stock, non-GAAP adjusted net income available to common stockholders was $5.5 million, or $0.21 per diluted share. Reconciliations of applicable GAAP measures to non-GAAP adjusted information are included at the end of this press release.

    As of December 31, 2020, Harmony had cash and cash equivalents of $228.6 million compared to $24.5 million for the same period in 2019.

    2020 Select Business Highlights

    Initial Public Offering

    On August 21, 2020, Harmony completed an upsized initial public offering of 6.15 million primary shares of common stock at $24.00 per share, which began trading on the Nasdaq Global Market under the ticker symbol "HRMY". The gross proceeds, before deducting any discounts, commissions or expenses, were $147.6 million. Goldman Sachs, Jefferies and Piper Sandler managed the deal.

    FDA Approved New Indication for WAKIX

    On October 13, 2020, the 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. In August 2019, the FDA approved WAKIX as the first treatment for EDS associated with narcolepsy that is not scheduled as a controlled substance by the U.S. Drug Enforcement Administration.

    Advances in WAKIX Clinical Programs

    On December 15, 2020 Harmony enrolled the first patient in a Phase 2 randomized, double-blind, placebo-controlled trial for EDS in patients with PWS, a rare genetic condition. The trial is designed to evaluate the safety and efficacy of WAKIX for EDS and other symptoms (behavioral, cognitive dysfunction) in patients with PWS. Harmony expects to report top-line results in first half of 2022.

    In December 2020, Harmony submitted an Investigational New Drug (IND) application to the FDA to evaluate pitolisant in patients with myotonic dystrophy (DM). The IND opened in January 2021 and Harmony is on-track to initiate a Phase 2 trial in patients with DM the first half of 2021.



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

    We are hosting our fourth quarter and full-year 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 5049024. A replay will be accessible until April 1, 2021 by dialing (855) 859-2056 (domestic) or +1 (404) 537-3406 (international).

    Non-GAAP Financial Measures

    In addition to our GAAP results, we provide certain non-GAAP metrics including adjusted net income and adjusted net income per share. We believe that the presentation of these measures provides important supplemental information to management and investors regarding our performance. These measurements are not a substitute for GAAP measurements, and the manner in which we calculate adjusted net income and adjusted net income per share may not be identical to the manner in which other companies calculate adjusted net income and adjusted net income per share. Company management uses these non-GAAP measurements as an aid in monitoring our on-going financial performance from quarter-to-quarter and year-to-year on a regular basis and for benchmarking against comparable companies.

    These non-GAAP financial measures are not meant to be considered in isolation or as a substitute for comparable GAAP measures; should be read in conjunction with our consolidated financial statements prepared in accordance with GAAP; have no standardized meaning prescribed by GAAP; and are not prepared under any comprehensive set of accounting rules or principles. In addition, from time to time in the future there may be other items that we may exclude for purposes of its non-GAAP financial measures; and we may in the future cease to exclude items that it has historically excluded for purposes of its non-GAAP financial measures.

    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. 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 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. 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 Harmony'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 Annual Report on Form 10-K filed with the Securities and Exchange Commission (the "SEC") on March 25, 2021, 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.

    CONSOLIDATED

    STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

    (In thousands except share and per share data)

    (unaudited)

      Three Months Ended

    December 31,
      Twelve Months Ended

    December 31,
     
      2020  2019  2020  2019 
    Net product revenues $56,288  $5,995  $159,742  $5,995 
    Cost of product sold  9,918   1,577   27,738   1,577 
    Gross profit  46,370   4,418   132,004   4,418 
    Operating expenses:                
    Research and development  7,618   5,276   19,448   69,595 
    Sales and marketing  17,526   16,841   55,824   44,318 
    General and administrative  13,466   15,995   39,746   36,409 
    Total operating expenses  38,610   38,112   115,018   150,322 
    Operating income (loss)  7,760   (33,694)  16,986   (145,904)
    Loss on debt extinguishment        (22,639)   
    Other expense, net        (3,071)   
    Interest expense, net  (7,966)  (2,747)  (28,220)  (6,073)
    Loss before income taxes  (206)  (36,441)  (36,944)  (151,977)
    Income taxes            
    Net loss and comprehensive loss $(206) $(36,441) $(36,944) $(151,977)
    Accumulation of dividends on preferred stock     (9,575)  (26,904)  (35,231)
    Net loss available to common stockholders $(206) $(46,016) $(63,848) $(187,208)
    NET LOSS PER SHARE:                
    Basic $(0.00) $(5.92) $(2.48) $(24.07)
    Diluted $(0.00) $(5.92) $(2.48) $(24.07)
    Weighted average number of shares of common stock - basic  56,889,460   7,778,453   25,772,419   7,777,441 
    Weighted average number of shares of common stock - diluted  56,889,460   7,778,453   25,772,419   7,777,441 



    HARMONY BIOSCIENCES HOLDINGS, INC.

    CONSOLIDATED BALANCE SHEETS

    (In thousands except share and per share data)

      December 31,

    2020
      December 31,

    2019
     
    ASSETS        
    CURRENT ASSETS:        
    Cash and cash equivalents $228,631  $24,457 
    Trade receivables, net  22,176   4,255 
    Inventory, net  3,823   1,088 
    Prepaid expenses  6,959   1,436 
    Other current assets  1,302   261 
    Total current assets  262,891   31,497 
    NONCURRENT ASSETS:        
    Property and equipment, net  938   1,330 
    Restricted cash  750   750 
    Intangible asset, net  162,343   72,185 
    Other noncurrent assets  152   941 
    Total noncurrent assets  164,183   75,206 
    TOTAL ASSETS $427,074  $106,703 
    LIABILITIES, CONVERTIBLE PREFERRED STOCK, AND STOCKHOLDERS' EQUITY

    (DEFICIT)
            
    CURRENT LIABILITIES:        
    Trade payables $2,556  $6,360 
    Accrued compensation  8,942   7,917 
    Accrued expenses  122,727   5,500 
    Other current liabilities  314   115 
    Total current liabilities  134,539   19,892 
    NONCURRENT LIABILITIES:        
    Deferred rent  212   287 
    Long term debt, net  194,250   97,946 
    Other noncurrent liabilities  893   163 
    Total noncurrent liabilities  195,355   98,396 
       TOTAL LIABILITIES  329,894   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 December 31, 2020 and 2019, respectively; 0

       shares and 285,000,000 shares issued and outstanding at December 31, 2020 and

       2019, respectively
         348,203 
       Series B convertible preferred stock - $1.25 stated value; 0 shares and 8,030,000

       shares authorized at December 31, 2020 and 2019, respectively; 0 shares and

       8,000,000 shares issued and outstanding at December 31, 2020 and 2019,

       respectively
         12,023 
       Series C convertible preferred stock - $1.96 stated value; 0 shares and 25,600,000

       shares authorized at December 31, 2020 and 2019, respectively; 0 shares and

       25,510,205 shares issued and outstanding at December 31, 2020 and 2019,

       respectively
         51,051 
    STOCKHOLDERS' EQUITY (DEFICIT):        
    Preferred stock - $0.00001 par value; 10,000,000 shares and 0 shares authorized at

    December 31, 2020 and 2019, respectively; 0 shares issued and outstanding at

    December 31, 2020 and 2019, respectively
          
    Common stock—$0.00001 par value; 500,000,000 shares and 423,630,000 shares

    authorized at December 31, 2020 and 2019, respectively; 56,890,569 shares and

    7,787,470 issued and outstanding at December 31, 2020 and 2019, respectively
      1    
    Additional paid in capital  585,374    
    Accumulated deficit  (488,195)  (422,862)
         TOTAL STOCKHOLDERS' EQUITY (DEFICIT)  97,180   (422,862)
    TOTAL LIABILITIES, CONVERTIBLE PREFERRED STOCK, AND STOCKHOLDERS'

    EQUITY (DEFICIT)
     $427,074  $106,703 



    HARMONY BIOSCIENCES HOLDINGS, INC.

    RECONCILIATION OF GAAP TO NON-GAAP RESULTS

    (In thousands except share and per share data)

    (unaudited)

      Three Months Ended

    December 31,
      Twelve Months Ended

    December 31,
     
      2020  2019  2020  2019 
    GAAP reported loss $(207)  $(36,439)  $(36,944) $(151,977)
    Non-GAAP adjustments:                
    Interest expense  7,967   2,747   28,220   6,073 
    Taxes            
    Depreciation  100   95   394   395 
    Amortization  4,283   1,850   9,843   2,815 
    EBITDA  12,143   (31,747)  1,513   (142,694)
    Additional non-GAAP adjustments:                
    Stock-based compensation expense  2,924   8,805   5,190   9,909 
    Loss on debt extinguishment        22,639    
    Warrant expense        3,109    
    Non-GAAP adjusted net income (loss)  15,067   (22,942)  32,451   (132,785)
    Accumulation of dividends on preferred stock     (9,575)  (26,904)  (35,231)
    Non-GAAP net income (loss) available to common stockholders $15,067  $(32,517) $5,547  $(168,016)
    GAAP reported net loss per diluted share $(0.00) $(5.92) $(2.48) $(24.07)
    Non-GAAP adjusted net income (loss) per diluted share $0.25  $(4.18) $0.21  $(21.60)
    Weighted average number of shares of common stock used in non-

    GAAP diluted per share
      59,128,981   7,778,453   26,982,978   7,777,441 

    Harmony Biosciences Investor Contact:

    Lisa Caperelli

    610-608-0215

    Harmony Biosciences Media Contact:

    Nancy Leone

    215-891-6046



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