HRMY Harmony Biosciences Holdings Inc.

43.25
-4.24  -9%
Previous Close 47.49
Open 47.52
52 Week Low 28.965
52 Week High 52.74
Market Cap $2,460,454,051
Shares 56,889,111
Float 10,705,696
Enterprise Value $2,672,781,881
Volume 215,753
Av. Daily Volume 190,885
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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. 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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  2. 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

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/harmony-biosciences-appoints-mark-graf-and-eric-motley-to-its-board-of-directors-301171325.html

    SOURCE Harmony Biosciences

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  3. PLYMOUTH MEETING, Pa. and CHICAGO, Oct. 28, 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 that it will issue a press release on the Company's third quarter financial results on Thursday, November 12, 2020 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 7489154. 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: 7489154. The replay will be available until November 19, 2020.

    About Harmony Biosciences

    Harmony Biosciences is a pharmaceutical company headquartered in Plymouth Meeting, PA and Chicago, IL. 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-third-quarter-2020-financial-results-301161163.html

    SOURCE Harmony Biosciences

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  4. PLYMOUTH MEETING, Pa. and CHICAGO, Oct. 14, 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 U.S. Food and Drug Administration (FDA) has approved WAKIX® (pitolisant) for the treatment of cataplexy in adult patients with narcolepsy. WAKIX is the first and only treatment approved by the FDA for people with excessive daytime sleepiness or cataplexy associated with narcolepsy that is not scheduled as a controlled substance by the U.S. Drug Enforcement Administration. WAKIX received FDA approval for the treatment of excessive…

    PLYMOUTH MEETING, Pa. and CHICAGO, Oct. 14, 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 U.S. Food and Drug Administration (FDA) has approved WAKIX® (pitolisant) for the treatment of cataplexy in adult patients with narcolepsy. WAKIX is the first and only treatment approved by the FDA for people with excessive daytime sleepiness or cataplexy associated with narcolepsy that is not scheduled as a controlled substance by the U.S. Drug Enforcement Administration. WAKIX received FDA approval for the treatment of excessive daytime sleepiness in adult patients with narcolepsy in August 2019.

    "All people living with narcolepsy have excessive daytime sleepiness and up to two-thirds of them also experience cataplexy, which is one of the most debilitating symptoms of this chronic, rare neurological disorder," said Harmony's Chief Medical Officer, Jeffrey Dayno, M.D. "Today's FDA approval of the cataplexy indication for WAKIX, coupled with it being the first and only non-scheduled treatment option approved for adult patients with narcolepsy to treat both excessive daytime sleepiness or cataplexy, provides an opportunity for WAKIX to offer broad clinical utility to healthcare professionals managing adult patients living with narcolepsy."

    "This approval underscores our ongoing commitment to support people who are living with narcolepsy," said John C. Jacobs, Harmony's President and Chief Executive Officer. "At Harmony, we always keep patients at the heart of all we do and with this approval, we are inspired to continue our mission to develop novel treatment options for those living with rare, neurological disorders who have unmet medical needs."

    "From the very beginning, our passion at Bioprojet has been to bring WAKIX to people living with the daily challenges that are associated with impaired wakefulness and the risk of cataplexy attacks. This approval highlights the recognition by the FDA of a new therapeutic option in the treatment of the two major symptoms of narcolepsy by a drug with a novel mechanism of action," said Professor Jean-Charles Schwartz, PhD. Professor Schwartz is the discoverer of histaminergic neurotransmission in the brain and the histamine-3 receptor, which is the target receptor of WAKIX. He is also the co-founder, with Jeanne-Marie Lecomte, of Bioprojet.

    WAKIX, a first-in-class medication, is a selective histamine 3 (H₃) receptor antagonist/inverse agonist that works through a novel mechanism of action to increase the synthesis and release of histamine, a wake-promoting neurotransmitter in the brain. WAKIX is administered orally, once daily in the morning upon wakening.

    FDA approval of WAKIX for the treatment of cataplexy in adult patients with narcolepsy is based on the results from two randomized, controlled trials (HARMONY CTP and HARMONY 1) from the clinical development program for WAKIX. After a complete response letter (CRL) for the cataplexy indication was issued by the FDA in August 2019, Harmony met with the Agency in December 2019 to discuss the deficiencies cited in the CRL. After that meeting, the FDA agreed to review the reanalysis of the HARMONY 1 data that were submitted during the NDA review, after which the Agency acknowledged that those analyses confirmed that a statistically significant reduction in the rate of cataplexy for WAKIX compared to placebo was demonstrated, which supported the positive results from the HARMONY CTP trial. Subsequently, the FDA recommended that Harmony submit a resubmission to the CRL, which Harmony submitted in August 2020 and has led to today's FDA approval of the cataplexy indication for WAKIX.

    Cataplexy is characterized by sudden, temporary loss of muscle tone and is often triggered by strong emotions, such as excitement or laughter. Cataplexy can be subtle, such as drooping of eyelids, or severe, such as knee buckling or total body collapse. Cataplexy may often go unrecognized because of the subtle nature of the symptoms in some patients, variability of how cataplexy is expressed, and/or lack of patient complaints or physician recognition of the symptoms as manifestations of cataplexy. Up to two-thirds of all patients with narcolepsy have cataplexy, which can have a significant impact on a person's daily functioning.

    About WAKIX® (pitolisant) Tablets

    WAKIX, a first-in-class medication, was approved by the U.S. Food and Drug Administration in August 2019 for the treatment of excessive daytime sleepiness 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.

    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 Narcolepsy

    Narcolepsy is a rare, chronic, debilitating neurological disorder of sleep-wake state instability that impacts up to 165,000 Americans and is primarily characterized by excessive daytime sleepiness (EDS) and cataplexy 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. Cataplexy is characterized by sudden temporary loss of muscle tone and is often triggered by strong emotions, such as excitement or laughter. 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 and Chicago, IL. 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. 

    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 final prospectus in connection with our initial public offering dated August 18, 2020 filed with the Securities and Exchange Commission (the "SEC") on August 19, 2020 pursuant to Rule 424(b) under the Securities Act of 1933, as amended, 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-receives-fda-approval-for-expanded-use-of-wakix-pitolisant-for-the-treatment-of-cataplexy-in-adult-patients-with-narcolepsy-301152078.html

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  5. PLYMOUTH MEETING, Pa. and CHICAGO, Sept. 22, 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 recipients of the second-annual Patients at the Heart Grant in recognition of World Narcolepsy Day. The Patients at the Heart Grant was originally designed as an annual competitive grant opportunity dedicated to funding innovative patient-centric programs; however, this year's grants were specifically awarded to programs created to support and address the unique challenges of people living with narcolepsy during the COVID-19 pandemic…

    PLYMOUTH MEETING, Pa. and CHICAGO, Sept. 22, 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 recipients of the second-annual Patients at the Heart Grant in recognition of World Narcolepsy Day. The Patients at the Heart Grant was originally designed as an annual competitive grant opportunity dedicated to funding innovative patient-centric programs; however, this year's grants were specifically awarded to programs created to support and address the unique challenges of people living with narcolepsy during the COVID-19 pandemic.

    "We are proud to recognize the second-annual World Narcolepsy Day by continuing to support the narcolepsy community, especially during a year when all of us need support more than ever," said Cate McCanless, Harmony's Vice President, External Affairs. "Being able to pivot our Patients at the Heart Grant opportunity to fund programs that support and address the challenges of people with narcolepsy during the COVID-19 pandemic underlines our commitment to keeping patients at the heart of everything we do."

    World Narcolepsy Day, which takes place on September 22, is a day dedicated to raising awareness of narcolepsy on a global scale. In 2020, the day is co-led by 26 patient advocacy organizations across six continents.

    The grant program awarded $65,000 to four organizations in 2019, a figure which this year rose to $74,000 awarded to three organizations. The following organizations were selected as grant recipients:

    Wake Up Narcolepsy (WUN)

    Program: Unique Digital Resource Collection

    These funds enabled the development of the 'Doing Life During COVID' page of the Wake Up Narcolepsy website. This page includes links to free and affordable resources on healthy eating, working from home, homeschooling, exercise apps, meditation and mental health resources, access to key areas of support and relevant organizations and more.

    Program: Digital Support Groups

    WUN offers free, targeted online support groups to individuals with narcolepsy and their families, world-wide. Programs are designed to bring together individuals who have been affected by the diagnosis of narcolepsy and provide the support and community necessary to thrive. These funds were used to aid the expansion of digital support groups due to the demand for online programming during COVID-19.

    Project Sleep

    Program: Rising Voices of Narcolepsy (RVN)

    Rising Voices of Narcolepsy, Project Sleep's leadership training program, helps people with narcolepsy share their story more effectively through writing and speaking. This online program empowers participants while fostering a new generation of narcolepsy advocates spreading awareness. In the wake of COVID-19, this program saw a significant increase in interested participants. Given its existing online format, this grant will enhance the program by providing more frequent opportunities for trained speakers and writers to share their story and offering additional support tools to help them adapt to the demands of a virtual presentation environment.

    Program: Narcolepsy Awareness Program (NAP)

    The NAP aims to reduce both self-stigma and societal stigma by providing people with narcolepsy with the leadership, role modeling, and information to feel hope, inspiration, connection and empowerment to succeed with narcolepsy. The grant was used to produce a new article and video series featuring health care professionals from the narcolepsy community and additional live broadcast interviews with key narcolepsy and sleep experts.

    Narcolepsy Network

    Program: Children's Outreach by Narcolepsy Network Educate, Connect, Thrive (CONNECT)

    Narcolepsy Network established the CONNECT program for youth that aims to address the needs and impact of COVID-19 on children and their parents affected by narcolepsy within the ages of 8-13 years old. The program will also aim to connect the community virtually to minimize the sense of seclusion fostered by COVID-19, as well as promote advocacy within the community by inviting a diverse audience and guest speakers.

    Program: Cooking Connects

    This webinar series will promote healthy eating for people with narcolepsy and their families and foster a sense of community during virtual times.

    Program: Narcolepsy Access Project (NAP)

    Due to COVID-19, Narcolepsy Network suspended their dozens of in-person support groups and utilized this grant to host virtual support group meetings.

    About Narcolepsy

    Narcolepsy is a rare, chronic, debilitating neurologic disorder of sleep-wake state instability that impacts up to 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 and Chicago, IL. The company was established in October 2017 by Paragon Biosciences, LLC, with a vision to provide novel treatment options for people living with rare, neurological disorders who have unmet medical needs. 

    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-announces-recipients-of-2020-patients-at-the-heart-grant-on-second-annual-world-narcolepsy-day-301133698.html

    SOURCE Harmony Biosciences

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