Patient Access and Clinical Trials - As of September 30, 2022, the average number of patients on WAKIX was approximately 4,600, with over 80% of all insured lives in the U.S. having formulary access[103] - The company initiated a Phase 3 registrational trial for idiopathic hypersomnia (IH) and has activated over 70% of the targeted clinical trial sites[97] - The topline data from the Phase 2 proof-of-concept trial for Prader-Willi Syndrome (PWS) showed a positive signal on the primary outcome related to excessive daytime sleepiness (EDS)[97] - The COVID-19 pandemic has impacted the company's ability to gauge growth rates and may adversely affect future growth due to changes in patient access to healthcare[105] - The company has observed a shift of some patients from commercial insurance to free drug and patient assistance programs due to elevated unemployment rates[109] - The company continues to engage and educate healthcare professionals virtually, despite challenges in in-person interactions due to the pandemic[107] - The COVID-19 pandemic has caused disruptions in clinical trials and may continue to affect the company's operations and financial results[116] - The company has implemented remote approaches to clinical trials to maintain patient safety and trial continuity during the pandemic[112] Financial Performance - Net product revenue for Q3 2022 was $117.206 million, an increase from $80.732 million in Q3 2021, representing a growth of 45.2%[141] - Gross profit for the nine months ended September 30, 2022, was $252.951 million, compared to $176.526 million for the same period in 2021, reflecting a year-over-year increase of 43.2%[141] - Operating income for the nine months ended September 30, 2022, was $72.573 million, compared to $58.897 million for the same period in 2021, showing an increase of 23.2%[141] - Net income for Q3 2022 was $87.943 million, a significant recovery from a net loss of $9.620 million in Q3 2021[141] - Net product revenue increased by $36.5 million, or 45.2%, for the three months ended September 30, 2022, and increased by $95.3 million, or 44.5%, for the nine months ended September 30, 2022, compared to the same periods in 2021[142] Expenses and Investments - Research and development expenses for Q3 2022 were $40.548 million, significantly higher than $11.739 million in Q3 2021, indicating an increase of 245.5%[141] - Sales and marketing expenses rose to $20.467 million in Q3 2022 from $16.480 million in Q3 2021, marking a 24.0% increase[141] - General and administrative expenses increased to $21.331 million in Q3 2022, up from $16.856 million in Q3 2021, which is a 26.5% rise[141] - Research and development expenses increased by $28.8 million, or 245.4%, for the three months ended September 30, 2022, and increased by $37.9 million, or 165.3%, for the nine months ended September 30, 2022, primarily due to a $30 million licensing fee[144] - Sales and marketing expenses increased by $4.0 million, or 24.2%, for the three months ended September 30, 2022, and increased by $9.2 million, or 18.8%, for the nine months ended September 30, 2022, driven by patient engagement and marketing activities[145][146] - General and administrative expenses increased by $4.5 million, or 26.5%, for the three months ended September 30, 2022, and increased by $15.7 million, or 34.3%, for the nine months ended September 30, 2022, primarily due to stock compensation and intangible asset amortization[147] Cash Flow and Financial Position - As of September 30, 2022, the company had cash, cash equivalents, restricted cash, and investments totaling $316.8 million, with an accumulated deficit of $320.6 million[151] - Net cash provided by operating activities for the nine months ended September 30, 2022 was $117.8 million, compared to $61.0 million for the same period in 2021[161] - The company made a $40 million milestone payment in March 2022 upon WAKIX attaining $500 million in life-to-date aggregate net sales in the United States[160] - As of September 30, 2022, the company had $235.2 million in investments in money market funds, U.S. treasury notes, corporate bonds, and municipal obligations[172] - The company had $198.0 million in borrowings outstanding as of September 30, 2022, with an Initial Term Loan interest rate of LIBOR plus 6.50%[173] Market and Economic Conditions - The EMA's decision on Bioprojet's pediatric narcolepsy submission is expected in the first quarter of 2023, which could inform the company's strategy for FDA submission[96] - The Blackstone Credit Agreement includes a senior secured term loan facility of $200 million and a delayed draw term loan facility of up to $100 million, with a maturity date of August 9, 2026[155] - An immediate 10% change in market interest rates would not have a material impact on the fair market value of the company's investment portfolio or its financial position[172] - The company is not currently exposed to significant market risk related to foreign currency exchange rates, but may contract with foreign vendors in the future[174] - Inflation has not had a material effect on the company's business, financial condition, or results of operations for the three and nine months ended September 30, 2022, and 2021[175]

Harmony Biosciences Holdings, Inc. (NASDAQ:HRMY) Q2 2022 Earnings Conference Call August 2, 2022 8:30 AM ET Company Participants Luis Sanay - Head, IR John Jacobs - President and CEO Jeffrey Dierks - Chief Commercial Officer Jeffrey Dayno - Chief Medical Officer Sandip Kapadia - CFO Conference Call Participants Chris Howerton - Jefferies Danielle Brill - Raymond James Charles Duncan - Cantor Fitzgerald Graig Suvannavejh - Goldman Sachs Corinne Jenkins - Goldman Sachs David Amsellem - Piper Sandler Francois ...

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 June 30, 2022 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 2022 Earnings Conference Call May 3, 2022 8:30 AM ET Company Participants Luis Sanay - Head, IR John C. Jacobs - President and CEO Jeffrey Dierks - Chief Commercial Officer Jeffrey M. Dayno - Chief Medical Officer Sandip Kapadia - CFO Conference Call Participants Danielle Brill - Raymond James Chris Howerton - Jefferies Charles Duncan - Cantor Fitzgerald David Amsellem - Piper Sandler Corinne Jenkins - Goldman Sachs Francois Brisebois - Oppenheimer Operato ...

Harmony Biosciences Q1 2022 Financial and Business Update May 3, 2022 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 consi ...

☐ 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. 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, 2022 OR (Exact name of registrant as specified in its charter) (State or oth ...

Harmony Biosciences Company Overview April 2022 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 considered forward-looking ...

Harmony Biosciences Holdings, Inc. (NASDAQ:HRMY) Q4 2021 Earnings Conference Call February 28, 2022 8:30 AM ET Company Participants Patti Bank - Investor Relations John Jacobs - President and Chief Executive Officer Jeffrey Dierks - Chief Commercial Officer Jeffrey Dayno - Chief Medical Officer Sandip Kapadia - Chief Financial Officer Conference Call Participants Danielle Brill - Raymond James Chris Howerton - Jefferies Ami Fadia - Needham David Amsellem - Piper Sandler Corinne Jenkins - Goldman Sachs Franç ...

HAR Harmony Biosciences Q4 2021 Financial and Business Update February 28, 2022 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, shoul ...

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, 2021 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) 630 W. Germant ...