Harmony Biosciences Holdings, Inc. (NASDAQ:HRMY) Q1 2021 Earnings Conference Call May 11, 2021 8:30 AM ET Company Participants Lisa Caperelli - IR John Jacobs - President & CEO Jeff Dierks - Chief Commercial Officer Jeff Dayno - Chief Medical Officer Sandip Kapadia - CFO Conference Call Participants David Amsellem - Piper Sandler Chris Howerton - Jefferies Graig Suvannavejh - Goldman Sachs Operator Ladies and gentlemen, thank you for standing by. And welcome to the Harmony Biosciences First Quarter 2021 Fin ...

Harmony Biosciences Q1 2021 Financial and Business Update May 11, 2021 Legal Disclaimer 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 cons ...

Financial Performance - For the three months ended March 31, 2021, the company generated $59.7 million in net product revenues[103] - Net product revenue increased by $39.8 million, or 200.8%, for the three months ended March 31, 2021, compared to the same period in 2020, driven by growing commercial sales of WAKIX and a price increase related to the cataplexy indication approval[143] - For the three months ended March 31, 2021, net product revenue was $59.7 million, while for the same period in 2020, it was $19.8 million[142] - Operating income for the three months ended March 31, 2021, was $14.5 million, compared to an operating loss of $9.6 million for the same period in 2020[142] - For the three months ended March 31, 2021, the company reported a net income of $7.386 million, a significant improvement from a net loss of $38.620 million in the same period of 2020[175] - Non-GAAP adjusted net income for the same period was $22.443 million, compared to a loss of $6.212 million in Q1 2020, indicating a strong recovery[175] - The GAAP reported net income per diluted share was $0.13, a notable increase from a loss of $6.30 per diluted share in Q1 2020[175] - The company reported EBITDA of $19.192 million for Q1 2021, compared to a negative EBITDA of $30.365 million in Q1 2020, reflecting improved operational performance[175] Revenue and Sales - As of March 31, 2021, over 2,700 unique healthcare professionals have prescribed WAKIX, with an average of approximately 2,800 patients on the medication[107] - The company has secured formulary access for approximately 80% of all insured lives in the United States[107] - The ongoing COVID-19 pandemic is expected to adversely impact revenue growth rates in future quarters due to reduced patient interactions and access to healthcare professionals[109] - The company continues to engage healthcare professionals virtually to mitigate the impact of COVID-19 on prescription demand for WAKIX[111] Expenses and Costs - The cost of product sales for the three months ended March 31, 2021, was $10.4 million, compared to $3.5 million for the same period in 2020[142] - Gross profit for the three months ended March 31, 2021, was $49.3 million, compared to $16.4 million for the same period in 2020[142] - Research and development expenses for the three months ended March 31, 2021, were $4.7 million, an increase from $3.4 million in the same period in 2020[142] - Sales and marketing expenses increased to $15.5 million for the three months ended March 31, 2021, compared to $13.3 million for the same period in 2020[142] - General and administrative expenses for the three months ended March 31, 2021, were $14.5 million, up from $9.3 million in the same period in 2020[142] - Cost of product sales increased by $6.9 million, or 199.6%, for the three months ended March 31, 2021, compared to the same period in 2020, primarily due to growing commercial sales of WAKIX[144] - Research and development expenses rose by $1.2 million, or 36.4%, for the three months ended March 31, 2021, compared to the same period in 2020, mainly due to clinical development work associated with PWS and DM[145] - Sales and marketing expenses increased by $2.3 million, or 17.0%, for the three months ended March 31, 2021, compared to the same period in 2020, primarily due to patient engagement and marketing activities[146] - General and administrative expenses increased by $5.3 million, or 56.6%, for the three months ended March 31, 2021, compared to the same period in 2020, mainly due to intangible asset amortization and stock compensation[147] Cash and Debt - The company had cash, cash equivalents, and restricted cash of $141.9 million as of March 31, 2021, with an accumulated deficit of $480.8 million[103] - The company has outstanding debt of $194.9 million as of March 31, 2021[103] - The company had $200.0 million in borrowings outstanding as of March 31, 2021, with a term loan interest rate of LIBOR or 2.00% per annum plus 11.00% per annum[177] - Interest expense increased by $0.8 million, or 11.8%, for the three months ended March 31, 2021, compared to the same period in 2020, primarily due to interest payments on the Loan Agreement[150] - The company has been in compliance with the financial covenants under the Credit Agreement since it was entered into on January 9, 2020[155] Future Plans and Developments - The company plans to pursue label expansion for WAKIX in pediatric patients with narcolepsy, with updates anticipated in the coming months[97] - The company is focusing on expanding its pipeline through the acquisition of additional assets targeting neurological disorders[100] - The company anticipates conducting clinical trials in Prader-Willi Syndrome and myotonic dystrophy, with topline results expected in the first half of 2022[98] - The company anticipates significant research and development expenses in the coming years as it advances clinical development programs and seeks regulatory approval for additional indications[128] - The company is actively managing its supply chain to mitigate potential disruptions due to the COVID-19 pandemic, ensuring adequate supply of WAKIX for the next 18 to 24 months[113] Market and Economic Conditions - The company does not currently face significant market risk related to foreign currency exchange rates, although it may contract with foreign vendors in the future[178] - Inflation has not materially affected the company's business or financial condition for the three months ended March 31, 2021, or 2020[179] - An immediate 10% change in the Prime Rate would not have a material impact on the company's debt-related obligations or financial position[177] Stock and Shares - The weighted average number of shares used in calculating non-GAAP diluted per share was 58,805,285, compared to 7,790,667 in the previous year[175] - Stock-based compensation expense increased to $3.251 million in Q1 2021 from $368,000 in Q1 2020, indicating increased investment in talent[175]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 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) Delaware 82-22 ...

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 September 30, 2020 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: 1-39450 HARMONY BIOSCIENCES HOLDINGS, INC. (Exact Name of Registrant as Specified in Its Charter) (State or Other Jurisdiction of Incorporati ...