Q2 2023 Financial and Business Update This presentation includes forward‐looking statements within the meaning of the Private Securities Reform Act of 1995. All statements other than statements of historical facts contained in these materials or elsewhere, including statements regarding Harmony Biosciences Holdings, Inc.'s (the "Company") future financial position, business strategy and plans and objectives of management for future operations, should be considered forward-looking statements. Forward-looking ...

Harmony Biosciences Holdings, Inc. (NASDAQ:HRMY) Q2 2023 Earnings Conference Call August 1, 2023 8:30 AM ET Company Participants Luis Sanay - Head, Investor Relations Dr. Jeffrey Dayno - President and CEO Jeffrey Dierks - Chief Commercial Officer Dr. Kumar Budur - Chief Medical Officer Sandip Kapadia - Chief Financial Officer Conference Call Participants Alex Sklar - Raymond James David Amsellem - Piper Sandler Francois Brisebois - Oppenheimer Graig Suvannavejh - Mizuho Securities Jason Gerberry - Bank of A ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) Table of Contents ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39450 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) (State or othe ...

Harmony Biosciences Holdings, Inc. (NASDAQ:HRMY) Q1 2023 Earnings Conference Call May 2, 2023 8:30 AM ET Company Participants Luis Sanay - Head, IR Jeffrey Dayno - President and CEO Jeffrey Dierks - CCO Sandip Kapadia - CFO Conference Call Participants Charles Duncan - Cantor Fitzgerald Francois Brisebois - Oppenheimer David Amsellem - Piper Sandler Graig Suvannavejh - Mizuho Securities Ami Fadia - Needham Corinne Jenkins - Goldman Sachs Jason Gerberry - Bank of America Danielle Brill - Raymond James Operat ...

Our Corporate Growth Strategy Acquire New Assets WAKIX® Net Revenue Performance U.S. Covered Lives With Formulary Access >80% Average # of Patients on WAKIX ~5,100 Continued Growth in Depth & Breadth of Prescriber Base ~85% In-Person Access to HCPs 1. Includes New Drug Applications and supplemental New Drug Applications. 2. Trial conducted by Bioprojet and Bioprojetsubmitted regulatory package to EMA. Bioprojet received EMA approval on March 15, 2023. | --- | --- | --- | --- | --- | --- | --- | --- | |----- ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39450 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact name of registrant as specified in its charter) (State or oth ...

Harmony Biosciences Holdings, Inc. (NASDAQ:HRMY) Q4 2022 Earnings Conference Call February 21, 2023 8:30 AM ET Company Participants Luis Sanay - Head-Investor Relations Jeffrey Dierks - Chief Commercial Officer Jeffrey Dayno - Interm CEO & Chief Medical Officer Sandip Kapadia - Chief Financial Officer Conference Call Participants Francois Brisebois - Oppenheimer David Amsellem - Piper Sandler Chris Howerton - Jefferies Charles Duncan - Cantor Fitzgerald Corinne Jenkins - Goldman Sachs Ami Fadia - Needham Gr ...

Forward Looking Statements Our Three-Pillar Growth Strategy February 21, 2023 This presentation includes information related to market opportunity as well as cost and other estimates obtained from internal analyses and external sources. The internal analyses are based upon management's understanding of market and industry conditions and have not been verified by independent sources. Similarly, the externally sourced information has been obtained from sources the Company believes to be reliable, but the accu ...

Product Overview - WAKIX (pitolisant) is the first-and-only FDA-approved treatment for narcolepsy that is not scheduled as a controlled substance, addressing a significant unmet need for non-scheduled treatment options [30]. - WAKIX can be used as monotherapy or in combination with other narcolepsy treatments, providing flexibility for healthcare providers [30]. - WAKIX was launched in November 2019, with a dedicated sales team of over 80 members targeting approximately 9,500 healthcare providers (HCPs) in the narcolepsy market [32]. - WAKIX was approved for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy in August 2019 and for cataplexy in October 2020 [156]. Market Opportunity - The U.S. narcolepsy market had an approximate net sales value of $2.3 billion in 2022, with expected growth driven by new therapies and increased diagnosis rates [25]. - Approximately 165,000 Americans are estimated to be affected by narcolepsy, with fewer than 50% diagnosed, highlighting the need for improved awareness and treatment options [25]. - The revenue from WAKIX will depend on the size of the addressable patient market, competition, pricing acceptance, and reimbursement capabilities [160]. - The market opportunity for WAKIX may be smaller than estimated, with assumptions based on current market size and pricing that could prove incorrect [167]. Clinical Trials and Development - The company initiated a Phase 3 trial for idiopathic hypersomnia (IH) in April 2022, with approximately 85% of targeted clinical trial sites activated [18]. - A Phase 2 proof-of-concept trial for pitolisant in Prader-Willi Syndrome (PWS) showed positive signals for improvement in excessive daytime sleepiness (EDS) [18]. - The company is pursuing new indications for pitolisant, including a Phase 3 trial for idiopathic hypersomnia (IH) initiated in April 2022, with 85% of clinical trial sites activated [42]. - The company anticipates topline results from a Phase 2 trial evaluating pitolisant for EDS, fatigue, and cognitive dysfunction in adult patients with DM1 in Q4 2023 [42]. - The company plans to advance its development program for patients with PWS into a Phase 3 trial following the analysis of Phase 2 trial results, with topline results anticipated in Q4 2023 [52][54]. Regulatory and Compliance - The FDA regulates the drug development process, requiring substantial time and financial resources for compliance [86]. - The FDA aims for a ten-month review period for standard NDAs for new molecular entities, which typically extends to twelve months due to preliminary review processes [91]. - The FDA may require a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of a drug outweigh its risks, which can include restricted distribution methods and patient registries [92]. - The company must comply with various federal healthcare laws and regulations that restrict business practices in the pharmaceutical industry, impacting operations and marketing [125]. Financials and Revenue - For the year ended December 31, 2022, three customers accounted for 100% of gross product revenues, with Caremark LLC contributing 42% [70]. - The company paid an initial license fee of $150.0 million and milestone payments totaling $165.0 million to Bioprojet for the WAKIX product, with aggregate net sales in the U.S. reaching $500.0 million by March 2022 [72]. - The company entered into a new agreement (2022 LCA) with Bioprojet, paying an initial non-refundable licensing fee of $30.0 million and potential additional payments of up to $155.0 million based on development and sales milestones [74]. Competition and Market Challenges - The company faces competition from various pharmaceutical companies, with key factors for success including efficacy, safety, and pricing of its products [62][65]. - The company faces significant competition from larger pharmaceutical companies and generic drug manufacturers, which may hinder its market share and revenue potential [197][198]. - The commercial adoption of WAKIX will depend on market acceptance and the ability to obtain adequate coverage and reimbursement from third-party payors [157]. - The regulatory approval process for new indications is costly and unpredictable, impacting the company's ability to expand WAKIX's market [157]. Intellectual Property and Licensing - The company relies on license agreements with Bioprojet for core intellectual property related to pitolisant, and any loss of these rights would adversely affect commercialization efforts [168]. - The company’s patent portfolio includes three U.S. patents for WAKIX, with expiration dates ranging from March 2030 to September 2029 [78]. - The HBS-102 patent portfolio consists of three families, with key patents expected to expire between April 2031 and January 2029 [79]. Operational Risks - The company relies on third-party manufacturers for the production and distribution of WAKIX, ensuring compliance with extensive regulatory requirements [66][67]. - The company has experienced minor supply issues with third-party manufacturers prior to the approval of WAKIX, which could impact future product availability [191][193]. - The company relies heavily on third parties for clinical trials and manufacturing, which may lead to delays and increased costs if these parties do not meet their obligations [185][191][189]. Corporate Governance and Social Responsibility - The company is committed to corporate social responsibility, focusing on ethical business practices and community engagement [150]. - The company has established disaster recovery and business continuity plans, but these may prove inadequate in the event of a serious disaster, potentially leading to significant expenses and operational disruptions [210]. Employee and Management Considerations - The company has 200 full-time employees, with 107 dedicated to commercial functions and 44 to research and development [147]. - Future growth will impose significant responsibilities on management, including hiring and retaining qualified personnel [199][201]. - The company faces intense competition for hiring qualified personnel in operations, finance, scientific, and clinical roles, which may increase compensation costs and affect business operations [205].

Harmony Biosciences Holdings, Inc. (NASDAQ:HRMY) Q3 2022 Earnings Conference Call November 1, 2022 8:30 AM ET Company Participants Luis Sanay - Head-Investor Relations John Jacobs - President & Chief Executive Officer Jeffrey Dierks - Chief Commercial Officer Jeffrey Dayno - Chief Medical Officer Sandip Kapadia - Chief Financial Officer Conference Call Participants Francois Brisebois - Oppenheimer David Amsellem - Piper Sandler Charles Duncan - Cantor Fitzgerald Corinne Jenkins - Goldman Sachs Chris Howerto ...