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 ...

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]

Financial Data and Key Metrics Changes - Harmony Biosciences reported net revenues of $107 million for Q2 2022, representing a 45% year-over-year increase from $73.8 million in the prior year quarter [29] - Operating income for Q2 2022 was $33.1 million, a 42% increase compared to $23.3 million in the prior year quarter [30] - Non-GAAP adjusted net income for Q2 was $34.7 million or $0.57 per diluted share, compared to $21.9 million or $0.37 per diluted share in the prior year quarter [30] Business Line Data and Key Metrics Changes - The WAKIX product line achieved net sales of $107 million in Q2 2022, marking the first time quarterly revenue surpassed $100 million [8] - The average number of patients on WAKIX increased to approximately 4,300 in Q2 2022, reflecting strong organic demand [14] - The company observed strong refill behavior and new patient starts, with Q2 representing the strongest quarter of prescription demand in over two years [15][20] Market Data and Key Metrics Changes - The company noted a significant increase in in-person field sales engagement, with approximately 75% of all engagements being in-person during Q2 2022 [16] - There was a broadening of clinical adoption of WAKIX among healthcare professionals, with new prescribers increasing in Q2 2022 [17] - Market access for WAKIX improved, facilitating patient access to the medication [18] Company Strategy and Development Direction - Harmony's growth strategy is based on three pillars: optimizing WAKIX's commercial performance, expanding its clinical utility, and acquiring new assets [6][10] - The company announced a new agreement with Bioprojet to develop innovative therapeutics based on pitolisant, aiming to expand its portfolio beyond WAKIX [10][11] - Harmony intends to leverage its financial position to acquire additional assets in neurology, focusing on rare orphan diseases [11][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in making 2022 the best year yet for Harmony, driven by strong demand for WAKIX and ongoing clinical programs [6][12] - The company anticipates typical seasonal headwinds in Q3 but expects a strong Q4 performance [31] - Management remains optimistic about WAKIX becoming a potential $1 billion franchise in the coming years [12] Other Important Information - Harmony ended Q2 2022 with approximately $258.9 million in cash, cash equivalents, and investments [31] - The company plans to incur a $30 million upfront fee related to the Bioprojet agreement in Q3 2022 [31] Q&A Session Summary Question: Impact of different physician practices on prescribing - The initial target audience consisted of about 8,000 healthcare professionals, covering 90% of the patient opportunity, while an additional 1,000 physicians managed about 10% [38] Question: Details on the Bioprojet relationship - The agreement focuses on developing new therapies based on pitolisant, potentially expanding the franchise in narcolepsy and other mutually agreed indications [39] Question: Momentum in prescription demand - The momentum exiting Q2 was as strong as entering it, with Q2 being the strongest quarter for prescription demand in two years [45] Question: Seasonal impact in Q3 - Typical summer seasonality is expected, with fewer patient visits and more vacation time affecting performance [50] Question: Increase in new patients over the year - The company anticipates continued growth due to strong underlying demand but is not providing forward-looking guidance [55] Question: Mechanistic rationale for pitolisant in Prader-Willi syndrome - Prader-Willi syndrome involves hypothalamic dysfunction, which may lead to excessive daytime sleepiness, making pitolisant a suitable treatment option [58] Question: Off-label usage of WAKIX for idiopathic hypersomnia - There is excitement in the community, but off-label usage is limited due to WAKIX being a higher-priced specialty product without FDA approval for that indication [99]

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 ...

[Part I. Financial Information](index=3&type=section&id=Part%20I.%20Financial%20Information) [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) The unaudited condensed consolidated financial statements for Q1 2022 reflect substantial growth in revenues and net income, with increased assets and strong liquidity [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20%28Unaudited%29) Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2022 | December 31, 2021 | | :--- | :--- | :--- | | **Total Current Assets** | $280,257 | $284,439 | | Cash and cash equivalents | $224,499 | $234,309 | | **Total Noncurrent Assets** | $183,748 | $149,004 | | Intangible assets, net | $178,837 | $143,919 | | **TOTAL ASSETS** | **$464,005** | **$433,443** | | **Total Current Liabilities** | $56,528 | $53,775 | | **Total Noncurrent Liabilities** | $192,974 | $193,161 | | Long term debt, net | $189,896 | $189,984 | | **TOTAL LIABILITIES** | **$249,502** | **$246,936** | | **TOTAL STOCKHOLDERS' EQUITY** | **$214,503** | **$186,507** | - Total assets increased to **$464.0 million** as of March 31, 2022, from **$433.4 million** at year-end 2021, primarily driven by a **$34.9 million** increase in net intangible assets[9](index=9&type=chunk) - Total stockholders' equity grew by **$28.0 million** during the first quarter of 2022, reaching **$214.5 million**, mainly due to net income of **$21.5 million**[9](index=9&type=chunk)[11](index=11&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Income](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Income%20%28Unaudited%29) Statement of Operations Highlights (in thousands, except per share data) | Metric | Q1 2022 | Q1 2021 | % Change | | :--- | :--- | :--- | :--- | | Net product revenues | $85,313 | $59,674 | 43.0% | | Gross profit | $70,597 | $49,265 | 43.3% | | Total operating expenses | $43,041 | $34,732 | 23.9% | | Operating income | $27,556 | $14,533 | 89.6% | | Net income | $21,485 | $7,386 | 191.0% | | Diluted EPS | $0.35 | $0.13 | 169.2% | - The company demonstrated strong top-line growth, with net product revenues increasing **43.0%** year-over-year, leading to a significant **191.0%** increase in net income[10](index=10&type=chunk) [Condensed Consolidated Statements of Stockholders' Equity](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity%20%28Unaudited%29) - Total stockholders' equity increased from **$186.5 million** at the end of 2021 to **$214.5 million** as of March 31, 2022. The increase was primarily driven by **$21.5 million** in net income for the quarter[11](index=11&type=chunk) - Stock-based compensation expense added **$4.6 million** to additional paid-in capital during the first quarter of 2022[11](index=11&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20%28Unaudited%29) Cash Flow Summary (in thousands) | Activity | Q1 2022 | Q1 2021 | | :--- | :--- | :--- | | Net cash provided by operating activities | $28,852 | $12,530 | | Net cash used in investing activities | ($40,045) | ($100,004) | | Net cash provided by financing activities | $1,383 | $12 | | **Net decrease in cash** | **($9,810)** | **($87,462)** | - Cash from operating activities more than doubled to **$28.9 million** in Q1 2022 from **$12.5 million** in Q1 2021, driven by higher net income[12](index=12&type=chunk) - Investing activities primarily consisted of a **$40.0 million** milestone payment in Q1 2022, compared to a **$100.0 million** milestone payment in Q1 2021[12](index=12&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements%20%28Unaudited%29) - As of March 31, 2022, three customers (CVS Caremark, Accredo, and Pantherx) accounted for **100%** of gross accounts receivable and **100%** of gross product revenues[28](index=28&type=chunk)[29](index=29&type=chunk) - In February 2022, the company achieved **$500 million** in aggregate net sales of WAKIX, triggering a final **$40.0 million** milestone payment which was capitalized as an intangible asset[36](index=36&type=chunk) - The company has a **$200 million** senior secured term loan facility with Blackstone, with **$199.0 million** in principal outstanding as of March 31, 2022[41](index=41&type=chunk)[44](index=44&type=chunk) - Diluted earnings per share for Q1 2022 was **$0.35**, calculated using the treasury stock method with **60,586,875** weighted average diluted shares outstanding[10](index=10&type=chunk)[66](index=66&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management attributes strong revenue growth to WAKIX patient expansion, with increased R&D expenses and solid liquidity maintained despite COVID-19 challenges [Company Overview and Strategy](index=26&type=section&id=Company%20Overview%20and%20Strategy) - Harmony is a commercial-stage pharmaceutical company focused on rare neurological diseases, with its primary product being WAKIX (pitolisant), approved for treating EDS and cataplexy in adult narcolepsy patients[76](index=76&type=chunk)[79](index=79&type=chunk) - The company is pursuing label expansion for WAKIX in pediatric narcolepsy and is advancing clinical trials for other indications, including Prader-Willi Syndrome (PWS), myotonic dystrophy (DM), and idiopathic hypersomnia (IH)[80](index=80&type=chunk)[81](index=81&type=chunk) - In August 2021, Harmony expanded its pipeline by acquiring **HBS-102**, a potential first-in-class molecule for which it plans a preclinical proof-of-concept study in a mouse model of PWS in 2022[82](index=82&type=chunk) [Commercial Performance and COVID-19 Impact](index=30&type=section&id=Commercial%20Performance%20and%20COVID-19%20Impact) - The average number of patients on WAKIX was approximately **3,900** for the three months ended March 31, 2022[87](index=87&type=chunk) - As of March 31, 2022, the company has secured formulary access for WAKIX for over **80%** of all insured lives in the United States[87](index=87&type=chunk) - The COVID-19 pandemic has negatively impacted business by reducing in-person access to healthcare professionals (HCPs) and affecting the ability to conduct clinical trials, though the company has implemented virtual engagement and remote trial monitoring to mitigate these effects[89](index=89&type=chunk)[91](index=91&type=chunk)[96](index=96&type=chunk) - The company expects to have an adequate supply of WAKIX into the second quarter of **2023**, with additional API inventory to support at least **36 months** beyond that[94](index=94&type=chunk) [Results of Operations](index=40&type=section&id=Results%20of%20Operations) Comparison of Results for the Three Months Ended March 31 (in thousands) | Line Item | 2022 | 2021 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Net product revenue | $85,313 | $59,674 | $25,639 | 43.0% | | Cost of product sales | $14,716 | $10,409 | $4,307 | 41.4% | | Research and development | $7,578 | $4,679 | $2,899 | 62.0% | | Sales and marketing | $17,583 | $15,506 | $2,077 | 13.4% | | General and administrative | $17,880 | $14,547 | $3,333 | 22.9% | | Net income | $21,485 | $7,386 | $14,099 | 191.0% | - The **43.0%** increase in net product revenue was driven by growth in the average number of patients on WAKIX[123](index=123&type=chunk) - R&D expenses increased by **62.0%** primarily due to clinical development work for PWS, DM, and IH, along with higher stock compensation[125](index=125&type=chunk) - G&A expenses rose **22.9%**, mainly from increased stock compensation and higher intangible asset amortization following a recent milestone payment[127](index=127&type=chunk) [Liquidity and Capital Resources](index=41&type=section&id=Liquidity%20and%20Capital%20Resources) - As of March 31, 2022, the company had **$225.2 million** in cash, cash equivalents, and restricted cash[131](index=131&type=chunk) - The company has an outstanding debt of **$199.0 million** under its Blackstone Credit Agreement, which also provides for a senior secured delayed draw term loan facility of up to **$100.0 million** available through August 9, 2022[131](index=131&type=chunk)[134](index=134&type=chunk) - In March 2022, the company made a final **$40.0 million** milestone payment to Bioprojet after WAKIX achieved **$500.0 million** in aggregate net sales in the U.S[139](index=139&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=45&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company faces interest rate risk on variable-rate debt, though a 10% LIBOR change is not material, and currently has limited foreign currency or inflation exposure - The company's primary market risk is interest rate sensitivity on its **$199.0 million** in outstanding variable-rate debt (LIBOR + **6.50%**). However, management states a **10%** change in LIBOR would not have a material impact[150](index=150&type=chunk) - The company is not currently exposed to significant foreign currency fluctuation risk but may be in the future due to contracts with European vendors[151](index=151&type=chunk) - Inflation is not considered to have had a material effect on the business for the three months ended March 31, 2022[152](index=152&type=chunk) [Controls and Procedures](index=45&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded the company's disclosure controls and procedures were effective as of March 31, 2022, with no material changes in internal control over financial reporting - Based on an evaluation as of March 31, 2022, the principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were effective[153](index=153&type=chunk) - No changes in internal control over financial reporting occurred during the quarter ended March 31, 2022, that have materially affected, or are reasonably likely to materially affect, internal controls[154](index=154&type=chunk) [Part II. Other Information](index=47&type=section&id=Part%20II.%20Other%20Information) [Legal Proceedings](index=47&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no pending claims or actions that could materially adversely affect its operations or financial condition - As of the filing date, management believes there are no pending legal proceedings that would materially impact the company's financial condition[159](index=159&type=chunk) [Risk Factors](index=47&type=section&id=Item%201A.%20Risk%20Factors) No material changes to the risk factors previously disclosed in the Annual Report on Form 10-K for the year ended December 31, 2021, have occurred - The report refers investors to the risk factors detailed in the Annual Report on Form 10-K for the year ended December 31, 2021, for a comprehensive discussion of risks affecting the company[160](index=160&type=chunk) [Other Required Disclosures](index=47&type=section&id=Items%202-5.%20Other%20Required%20Disclosures) The company reported no unregistered equity sales, no defaults on senior securities, and no other material disclosures under these items, with mine safety disclosures being not applicable - Item 2 (Unregistered Sales of Equity Securities), Item 3 (Defaults upon Senior Securities), and Item 5 (Other Information) are all reported as "None"[161](index=161&type=chunk)[162](index=162&type=chunk)[164](index=164&type=chunk) - Item 4 (Mine Safety Disclosures) is reported as "Not applicable"[163](index=163&type=chunk) [Exhibits](index=48&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the quarterly report, including CEO and CFO certifications and financial statements in Inline XBRL format - The exhibits filed with this report include CEO and CFO certifications pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act[166](index=166&type=chunk) - Financial statements are provided in Inline XBRL format as part of the filing[166](index=166&type=chunk)

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 ...

Financial Data and Key Metrics Changes - For Q4 2021, the company reported net revenues of $91.2 million, representing a 62% increase compared to the same quarter in the prior year and a 13% increase from Q3 2021 [14][40] - Full-year 2021 net revenue was $305.4 million, reflecting a 91% increase from 2020 [14][40] - Operating income for Q4 2021 was $28.6 million, compared to $7.8 million in the prior year quarter, while full-year operating income was $87.5 million, an increase of over $70 million compared to 2020 [41][42] Business Line Data and Key Metrics Changes - The average number of patients on WAKIX increased to approximately 3,800, representing a 9% increase from the previous quarter [15] - The company continues to see strong underlying demand for WAKIX, with a significant portion of new prescriptions coming from both type 1 and type 2 narcolepsy patients [20][21] Market Data and Key Metrics Changes - Market access for WAKIX remains strong, with over 80% of U.S. covered lives having favorable published policy access [19] - The narcolepsy market is currently valued at over $2 billion, indicating a large and growing opportunity for WAKIX [8] Company Strategy and Development Direction - The company aims to evolve into a leading rare orphan neurology company with a robust multiproduct portfolio and significant long-term growth potential [7][13] - The three pillars of the growth strategy include optimizing WAKIX's commercial performance, expanding its clinical utility beyond narcolepsy, and acquiring new assets to broaden the portfolio [8][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in building upon the momentum from 2021 and making 2022 the best year yet, with expectations for continued growth in WAKIX sales [7][47] - The company is optimistic about the potential of WAKIX to become a $1 billion-plus franchise through narcolepsy and additional indications [12][45] Other Important Information - The company generated $44.6 million in cash during Q4 2021, closing with $234.3 million in cash and cash equivalents at year-end [44] - The company plans to make a final milestone payment of $40 million to its partner, Bioprojet, in Q1 2022 [44] Q&A Session Summary Question: How should the company think about Q1, given the deductible reset and general seasonality? - Management indicated that while they are not providing specific guidance, they anticipate continued growth based on historical performance [49][50] Question: What is the status of enrollment in the ongoing Phase 2 trials? - Management noted that enrollment has improved due to contingency plans and flexibility in trial designs, with a focus on maintaining momentum [61][64] Question: What portion of narcolepsy patients are currently treated by the additional healthcare providers being targeted? - Approximately 10% of the patient opportunity resides within the additional 1,000 healthcare professionals being targeted, with these physicians managing a small number of narcolepsy patients [108] Question: How does the current market backdrop impact business development conversations? - Management noted a renewed interest in neurology and a favorable market backdrop facilitating deal discussions [111]