Press Releases

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PLYMOUTH MEETING, PA and CHICAGO, IL, November 12, 2020 — 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."

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PLYMOUTH MEETING, PA and CHICAGO, IL, November 11, 2020 — 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."

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PLYMOUTH MEETING, PA and CHICAGO, IL, October 28, 2020 — 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.

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PLYMOUTH MEETING, PA and CHICAGO, IL, October 13, 2020 — 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."

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PLYMOUTH MEETING, PA and CHICAGO, IL, September 22, 2020 — 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."

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PLYMOUTH MEETING, PA, and CHICAGO, IL, August 28, 2020 — Harmony Biosciences Holdings, Inc. ("Harmony") (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, announced today results from post-hoc analyses of the efficacy and safety data for WAKIX® (pitolisant) presented at the 34th Annual Meeting of the Associated Professional Sleep Societies (APSS), known as "SLEEP 2020." The meeting is being held virtually from August 27—30. Harmony is presenting a total of four posters in the Virtual SLEEP 2020 Exhibit Hall, three of which are post-hoc analyses of the efficacy and safety data from the clinical development program for WAKIX.

"We are pleased to participate in this year’s SLEEP 2020 virtual meeting and share clinically relevant data supporting WAKIX with healthcare professionals and the sleep medicine community," said Harmony’s Chief Medical Officer, Jeffrey Dayno, M.D. "The results presented from post-hoc analyses of the clinical data help further characterize the efficacy and safety profile of WAKIX to assist healthcare professionals in making treatment decisions for their patients living with narcolepsy."

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PLYMOUTH MEETING, PA, and CHICAGO, IL, August 24, 2020 — Harmony Biosciences Holdings, Inc. (“Harmony”) (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, announced today it will present new data on the safety and efficacy of WAKIX® (pitolisant), including four poster presentations at the upcoming 34th Annual Meeting of the Associated Professional Sleep Societies (APSS), known as “SLEEP 2020.” The meeting is being held virtually from August 27-30. Abstracts of the WAKIX data will also be published in the journal SLEEP as an online supplement.

The data include a final analysis of the Pitolisant Expanded Access Clinical Evaluation Program (PEACE), two post-hoc analyses on clinically relevant outcomes from the Phase 3 clinical trials, and analyses that further characterize the cardiac safety profile of WAKIX from the clinical development program.

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PLYMOUTH MEETING, PA and CHICAGO, IL, August 21, 2020 — Harmony Biosciences Holdings, Inc. (“Harmony”), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced it has closed its upsized initial public offering of 6,151,162 shares of common stock, including 802,325 shares sold pursuant to the exercise in full of the underwriters’ option to purchase additional shares of common stock, at the public offering price of $24.00 per share. The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Harmony, are expected to be $147.6 million. All of the shares were offered by Harmony.

Harmony shares began trading on the Nasdaq Global Market under the ticker symbol “HRMY” on August 19, 2020.

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PLYMOUTH MEETING, PA and CHICAGO, IL, August 18, 2020 — Harmony Biosciences Holdings, Inc., a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, announced today the pricing of its upsized initial public offering of 5,348,837 shares of common stock at a price to the public of $24.00 per share. The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Harmony, are expected to be $128.4 million. In addition, Harmony has granted the underwriters a 30-day option to purchase up to an additional 802,325 shares of common stock at the initial public offering price, less underwriting discounts and commissions. All of the shares are being offered by Harmony.

The shares are expected to begin trading on the Nasdaq Global Market under the ticker symbol “HRMY” on August 19, 2020. The offering is expected to close on August 21, 2020, pending customary closing conditions.

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PLYMOUTH MEETING, PA, July 30, 2020 — Harmony Biosciences (“Harmony”), a private pharmaceutical company dedicated to developing and commercializing novel treatment options for people living with rare, neurological diseases, announced today that the company is a recipient of Life Sciences Pennsylvania’s (LSPA) 2019 Patient Impact Award. Harmony was selected as an honoree based on the company’s continued efforts to support patients living with narcolepsy.

“At Harmony, patients are at the heart of everything we do. It is an honor to be recognized by LSPA for our work to contribute to the health and wellbeing of people living with narcolepsy,” said Cate McCanless, Vice President of External Affairs at Harmony. “We are proud to be recognized as a company that is making a difference in the lives of patients through our continued focus on scientific innovation, advocacy, and patient education.”

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PLYMOUTH MEETING, PA, June 2, 2020 — Harmony Biosciences, LLC (“Harmony”), a private pharmaceutical company dedicated to developing and commercializing novel treatment options for people living with rare diseases, announced today that it uploaded two posters with data on the efficacy and safety of WAKIX® (pitolisant) to the American Academy of Neurology (AAN) Science Highlights virtual platform. The abstracts of these posters are also included in an online supplement of the journal Neurology in the “Sleep Medicine: Focus on Therapies 2” poster session.

“We are pleased to have an opportunity to share these important data via this innovative approach with the broader neurology community,” said Harmony’s Chief Medical Officer, Jeffrey Dayno, M.D. “These data on the efficacy and safety of WAKIX strengthen the body of scientific evidence that supports WAKIX as a potential treatment option for adult patients living with narcolepsy.”

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PLYMOUTH MEETING, PA, April 29, 2020 — Harmony Biosciences, LLC (“Harmony”), a private pharmaceutical company dedicated to developing and commercializing novel treatment options for people living with rare diseases, announced today that the company has been recognized nationally among the top 10 biopharmaceutical companies on the 2020 Fortune Best Workplaces in Health Care & Biopharma™ list. Harmony earned this accolade based on an independent analysis conducted by Great Place to Work®, following results of a comprehensive, anonymous survey examining employee satisfaction and their workplace experiences.

“At Harmony, we put the wellbeing of the patients we serve and each of our employees at the heart of all we do,” said John C. Jacobs, President and CEO. “Being recognized by Fortune as a Best Workplace is an honor and speaks to the dedication our team has to upholding our company’s core values, maintaining a supportive and inclusive culture, and delivering value to patients by embracing innovation.”

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PLYMOUTH MEETING, PA, April 27, 2020 — Harmony Biosciences, LLC (“Harmony”), a private pharmaceutical company dedicated to developing and commercializing new treatment options for people living with rare diseases, today announced the company will expand narcolepsy community support efforts and reinforced its commitment to provide affordable access to treatment for people who have experienced a change in insurance or financial instability during the ongoing COVID-19 pandemic.

Harmony’s Patients at the Heart grant program underscores the company’s ongoing commitment to support the comprehensive needs of people affected by narcolepsy. The second annual Patients at the Heart grant program is being launched with increased funding to further support patient-centric organizations working to address the challenges of people living with narcolepsy during this time. The company’s patient support program will continue to provide medication free of charge for eligible patients who have lost health insurance or are underinsured, while providing “contactless” shipping for home delivery.

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PLYMOUTH MEETING, PA, March 30, 2020 — Harmony Biosciences, LLC (“Harmony”), a private pharmaceutical company dedicated to developing and commercializing novel treatment options for people living with rare diseases, announced today that Sleep Medicine has published an article which reviews the mechanism of action (MOA) of available treatments for patients with narcolepsy.

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PLYMOUTH MEETING, PA, February 3, 2020 — Harmony Biosciences, LLC (“Harmony”), a private pharmaceutical company dedicated to developing and commercializing novel treatment options for people living with rare diseases, announced today that the company has been certified as a great workplace for the second year in a row by independent analysts at Great Place to Work®. Harmony earned this credential based on ratings by its employees in an anonymous survey that provides benchmarks, framework and assessment to recognize outstanding workplace cultures.

“At Harmony, we keep patients at the heart of everything that we do, and everyone has ownership in the success of our company,” said John C. Jacobs, President and CEO. “We were deeply honored that, for the second year in a row, Harmony team members who participated in the survey rated the company as a ‘great place to work’ and cited our culture of one-team attitude, honest and transparent ways of working, and the ability to make a difference for patients and the broader community as contributing to an overall positive workplace experience.”

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PLYMOUTH MEETING, PA, January 27, 2020 — Harmony Biosciences, LLC (“Harmony”), a private pharmaceutical company dedicated to developing and commercializing novel treatment options for people living with rare diseases, announced today that it has completed a $200 million debt facility with OrbiMed Advisors LLC (“OrbiMed”), one of the leading investors in the healthcare industry, to provide additional capital to fuel the company’s continued growth.

“We are pleased to announce the completion of this debt facility with OrbiMed, a leading healthcare public and private market investment firm,” said John C. Jacobs, Chairman and CEO of Harmony. “With this financing, Harmony will be well positioned to continue to develop new medications consistent with our goal of helping additional people living with rare diseases.”

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PLYMOUTH MEETING, PA, November 20, 2019 — Harmony Biosciences, LLC (Harmony) announced today that data from two clinical studies evaluating the long-term safety and efficacy, as well as the human abuse potential of WAKIX® (pitolisant), have been published in SLEEP. WAKIX is a first-in-class medication with a novel mechanism of action and is approved for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy. It is the first and only U.S. Food and Drug Administration (FDA) approved product for patients with narcolepsy that is not scheduled as a controlled substance by the U.S. Drug Enforcement Administration (DEA).

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PLYMOUTH MEETING, PA, September 20, 2019 — Harmony Biosciences, LLC (Harmony) announced today the recipients of the inaugural Patients at the Heart Grant, a competitive grant opportunity to fund innovative, patient-centric programs for the narcolepsy community. Applicants were asked to submit proposals describing the goals of their program and how it will benefit people living with narcolepsy, as well as an evaluation plan with measurable indicators of success.

The original 2019 grant award was $50,000, but following the review of each application, the Patients at the Heart Grant review committee selected four organizations to receive grants totaling $65,000. The review committee was comprised of a diverse group of experts including cross-functional Harmony executives, a healthcare professional specializing in sleep disorders medicine and research, and a person living with narcolepsy.

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PLYMOUTH MEETING, PA, September 16, 2019 — Harmony Biosciences, LLC, (Harmony) announced today it will present clinical data on the efficacy and safety of WAKIX® (pitolisant) at the World Sleep 2019 meeting in Vancouver, Canada, from September 20-25, 2019. In an oral presentation, results will be presented from a randomized, double-blind, active- and placebo-controlled, four-sequence, four-way crossover study that evaluated the abuse potential of pitolisant compared with the stimulant phentermine HCl (C-IV) and placebo in non-dependent, recreational stimulant users. In addition, seven scientific posters will be presented, including a new post-hoc analysis of pooled data from two randomized, placebo-controlled, seven- and eight-week studies of pitolisant in adults with narcolepsy that evaluated the efficacy of WAKIX in patients with a high burden of narcolepsy symptoms.

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PLYMOUTH MEETING, PA, August 15, 2019 — Harmony Biosciences, LLC (Harmony) announced today that the U.S. Food and Drug Administration (FDA) approved WAKIX® (pitolisant) for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy. WAKIX is the first and only treatment approved for patients with narcolepsy that is not scheduled as a controlled substance by the U.S. Drug Enforcement Administration (DEA).

“We are extremely proud to bring WAKIX to market for those living with narcolepsy, a chronic, debilitating, rare neurologic disorder,” said Harmony’s Chairman and Chief Executive Officer, John C. Jacobs. “At Harmony we share a vision to develop novel treatment options for people living with rare diseases, with a focus on those that affect the central nervous system. The approval of WAKIX strengthens our commitment to making that vision a reality.”

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