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 ...

Financial Data and Key Metrics Changes - In Q2 2021, Harmony Biosciences reported net sales of nearly $74 million for WAKIX, representing a growth of approximately 24% compared to Q1 2021 [7][11] - The company achieved its second profitable quarter in history, with a net income of $14.1 million or $0.24 per diluted share, compared to a net loss of $10.5 million or a loss of $1.34 per share in the prior year quarter [28][29] - Non-GAAP adjusted net income for Q2 2021 was $31.9 million or $0.54 per share, compared to a net loss of $0.5 million or $0.07 per share in the prior year quarter [29] Business Line Data and Key Metrics Changes - The average number of patients on WAKIX increased by 15% from Q1 2021 to approximately 3,200 patients, with over two-thirds refilling prescriptions at the highest dose [12][16] - WAKIX's net revenue for Q2 2021 was $73.8 million, a 94.2% increase from $38 million in the prior year quarter [27] Market Data and Key Metrics Changes - Over 80% of all US-covered lives have favorable access to WAKIX, with recent positive formulary decisions aiding patient access [14] - The prescriber base for WAKIX grew, with over 38% of more than 8,000 healthcare professionals prescribing WAKIX since its launch [13] 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 expand its portfolio [7][10] - The acquisition of HBS-102, a potential first-in-class molecule, is seen as a significant step towards becoming a leading rare neurological disease company [9][19] - Harmony aims to leverage its existing expertise in rare neurological diseases to optimize development and launch while managing costs [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued growth of WAKIX, anticipating quarter-over-quarter revenue growth despite potential seasonal impacts [30][56] - The strategic collaboration with Blackstone provides additional capital and flexibility to support growth initiatives [25][26] Other Important Information - The company ended Q2 2021 with $159.7 million in cash, up from Q1, indicating a strong cash position [30] - The company is focused on maintaining a strong balance sheet while investing in R&D and expanding its product pipeline [32] Q&A Session Summary Question: Can you provide insights on the patient assistance programs and current patient trends? - Management noted an increased demand for the patient assistance program during the pandemic, which has remained consistent into Q2 2021, indicating strong underlying organic demand for WAKIX [41][43] Question: How does HBS-102 address unmet needs in REM-related symptoms? - Management highlighted that HBS-102 targets REM dysregulation, potentially addressing symptoms like cataplexy, hallucinations, and sleep paralysis, which are significant in the narcolepsy patient population [45][46] Question: What are the expectations for the second half of the year regarding COVID impacts? - Management indicated that the correlation between the opening of offices and increased patient visits has positively impacted WAKIX prescriptions, with strong underlying demand expected to continue [52][54] Question: How is the company planning to manage payer dynamics with new market entrants? - Management expressed confidence in WAKIX's unique mechanism of action, which differentiates it from competitors, and indicated that they do not foresee significant pushback from payers [82][83] Question: What is the appetite for acquiring commercial stage or late-stage assets? - Management stated that they are open to acquiring assets at various stages, focusing on those that align with their strategic growth objectives, supported by their strong cash position and recent financing [84]

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 ...

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 ...