Financial Data and Key Metrics Changes - The company reported net revenues of $80.7 million for Q3 2021, representing a 77% increase compared to Q3 2020 and a 9.4% increase from Q2 2021 [44][45] - Gross profit for Q3 2021 was $66.1 million, up from $37.7 million in the prior year quarter [45] - Operating income for Q3 2021 was $21.1 million, compared to $10.4 million in the prior year quarter [45] - Non-GAAP adjusted net income for Q3 2021 was $30.4 million or $0.51 per diluted share, compared to $13.7 million or $0.25 per diluted share in the prior year quarter [47] Business Line Data and Key Metrics Changes - Wakix achieved net sales of almost $81 million in Q3 2021, marking the seventh consecutive quarter of growth [8][18] - The average number of patients on Wakix increased approximately 10% from Q2 2021 to about 3,500 patients [19] - Over 80% of U.S. covered lives have favorable access to Wakix, with a significant increase in positive formulary decisions for narcolepsy patients with cataplexy [22][58] Market Data and Key Metrics Changes - The company observed strong organic growth for Wakix despite seasonal decreases in patient foot traffic during the summer [18][21] - The prescriber base for Wakix grew, with approximately 40% of healthcare professionals treating narcolepsy having prescribed Wakix since its launch [23] Company Strategy and Development Direction - The company is focused on three pillars: optimizing Wakix's commercial performance, expanding its clinical utility beyond narcolepsy, and acquiring new assets to diversify its portfolio [8][12] - The acquisition of HBS-102 marks the first step in expanding the pipeline beyond Wakix, targeting rare neurological diseases [13][14] - The strategic financing collaboration with Blackstone provides additional capital to support growth initiatives [15][49] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about continued growth in Q4 2021, driven by strong demand and improved access to healthcare professionals [50][88] - The company anticipates increased investments in R&D and SG&A while maintaining profitability [50] - Management highlighted the importance of addressing unmet needs in the narcolepsy market and the potential for expanding indications for Wakix [28][89] Other Important Information - The company incurred a one-time loss of $26.1 million due to the extinguishment of a prior debt facility, contributing to a net loss of $9.6 million for Q3 2021 [46] - The company generated $30.4 million from cash operations in Q3 2021, maintaining a strong cash position of $189.7 million as of September 30 [48] Q&A Session Summary Question: Coverage perspective and step edits for plans - The majority of plans for type 2 narcolepsy patients have one or two generic step edits, while type 1 patients have become less frequent in having these edits [57][58] Question: Expectations for covered lives and formulary access - Approximately 80% of U.S. insured lives have documented formulary access for Wakix, with the remaining 20% having paths for approval through medical necessity letters [58][59] Question: Status of pediatric narcolepsy trial - The partner Bioprojet is conducting a Phase 3 trial in pediatric patients, with data readout expected to inform future strategies [63] Question: Quarterly patient adds and prescription growth - The company has seen consistent growth in patient adds, with a mix of new prescribers and existing prescribers expanding their patient base [75][76] Question: Gross to net improvements and future expectations - The company expects stable gross to net ratios moving into Q4, with continued strong organic demand anticipated [88][89] Question: Exploration of idiopathic hypersomnia indication - The company is considering idiopathic hypersomnia as a potential indication for Wakix, with further exploration ongoing [89]

Table of Contents FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (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, 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. Indicate by check mark whether the registrant (1) has filed all ...

Harmony Biosciences Company Overview September 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 considered forward-look ...

Harmony Biosciences Holdings, Inc. (NASDAQ:HRMY) Q2 2021 Earnings Conference Call August 10, 2021 8:30 AM ET Company Participants John Jacobs - President & CEO Jeff Dierks - Chief Commercial Officer Jeff Dayno - Chief Medical Officer Sandip Kapadia - CFO Lisa Caperelli - IR Conference Call Participants Chris Howerton - Jefferies Graig Suvannavejh - Goldman Sachs David Amsellem - Piper Sandler Operator Good day, and thank you for standing by. Welcome to the Second Quarter 2021 Financial and Business Update C ...

Harmony Biosciences Q2 2021 Financial and Business Update August 10, 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 c ...

Financial Performance - For the six months ended June 30, 2021, the company generated $133.5 million in net product revenues[106]. - Net product revenue increased by $35.8 million, or 94.2%, for the three months ended June 30, 2021, and $75.7 million, or 130.8%, for the six months ended June 30, 2021 compared to the same periods in 2020, driven by growing commercial sales of WAKIX and a price increase following cataplexy indication approval[152]. - Net cash provided by operating activities was $30.6 million for the six months ended June 30, 2021, compared to net cash used of $21.9 million for the same period in 2020, reflecting revenue growth and net income from WAKIX commercialization[171]. - As of June 30, 2021, the company reported a net income of $14.1 million, compared to a net loss of $27 thousand in the same quarter of the previous year[188]. - Non-GAAP adjusted net income for the three months ended June 30, 2021, was $31.9 million, significantly up from $9.9 million in the prior year[188]. - EBITDA for the three months ended June 30, 2021, was $28.0 million, compared to $8.9 million in the same quarter of the previous year[188]. - The GAAP reported net income per diluted share for the quarter was $0.24, a recovery from a loss of $1.34 per share in the same quarter last year[188]. Product Development and Clinical Trials - The company plans to pursue label expansion for WAKIX in pediatric patients with narcolepsy, with ongoing Phase 3 trials by its strategic partner Bioprojet[100]. - The company initiated a Phase 2 clinical trial for pitolisant in patients with Prader-Willi Syndrome and anticipates topline results in the first half of 2022[101]. - Research and development expenses are expected to be significant over the next several years as the company advances clinical development programs and prepares for regulatory approval of additional indications for pitolisant[132]. - The COVID-19 pandemic has negatively impacted the ability to conduct clinical trials, potentially leading to significant delays in clinical development timelines[119]. - The company has implemented remote and virtual approaches to clinical trials to maintain patient safety and trial continuity during the pandemic[119]. Sales and Marketing - The company intends to maintain engagement and generate awareness to support commercial launch performance[112]. - Sales and marketing expenses are increasing to support the commercialization of WAKIX and anticipated growth from potential additional indications[138]. - Sales and marketing expenses grew by $4.6 million, or 36.8%, for the three months ended June 30, 2021, and $6.8 million, or 26.6%, for the six months ended June 30, 2021, attributed to patient engagement and marketing activities[155]. - The company continues to engage and educate healthcare professionals virtually, with plans to re-initiate in-person interactions as conditions allow[115]. Financial Position and Debt - As of June 30, 2021, the company had cash, cash equivalents, and restricted cash of $160.4 million, with an accumulated deficit of $466.7 million[106]. - The company has outstanding debt of $195.6 million as of June 30, 2021[106]. - The company entered into a new Credit Agreement on August 9, 2021, providing for a senior secured term loan facility of $200.0 million and a delayed draw term loan facility of up to $100.0 million[163]. - The company had $200.0 million in borrowings outstanding as of June 30, 2021, with a term loan interest rate of LIBOR or 2.00% per annum plus 11.00% per annum[190]. Cost and Expenses - The cost of product sales includes manufacturing and distribution costs, with a noted increase as production ramps up to meet expected demand for WAKIX[126]. - Cost of product sales rose by $6.2 million, or 96.5%, for the three months ended June 30, 2021, and $13.2 million, or 132.6%, for the six months ended June 30, 2021, primarily due to increased commercial sales of WAKIX[153]. - Research and development expenses increased by $2.3 million, or 55.9%, for the three months ended June 30, 2021, and $3.6 million, or 47.1%, for the six months ended June 30, 2021, mainly due to clinical development work associated with PWS and DM[154]. - General and administrative expenses are anticipated to increase to support ongoing commercialization efforts and compliance with public company requirements[141]. - General and administrative expenses increased by $6.7 million, or 87.5%, for the three months ended June 30, 2021, and $13.1 million, or 82.9%, for the six months ended June 30, 2021, primarily due to intangible asset amortization and increased headcount[156]. Market and Economic Conditions - The COVID-19 pandemic has impacted the company's business, affecting stakeholder interactions and patient medication adherence[111]. - The company has faced challenges in converting demand into revenue due to shifts in patient insurance coverage during the pandemic[116]. - Inflation has not materially affected the company's financial condition or results of operations for the three and six months ended June 30, 2021[192]. - An immediate 10% change in market interest rates would not have a material impact on the company's financial position or results of operations[189]. - 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[191].

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 ...

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, 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) Delaware 82-2 ...

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 ...