EX-99.2 3 d214785dex992.htm EX-99.2 EX-99.2

Exhibit 99.2 Harmony Biosciences Q2 2021 Financial and Business Update August 10, 2021Exhibit 99.2 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 considered forward-looking statements. Forward-looking statements use words like “believes,” “plans,” “expects,” “intends,” “will,” “would,” “anticipates,” “estimates,” and similar words or expressions in discussions of the Company’s future operations, financial performance or the Company’s strategies. These statements are based on current expectations or objectives that are inherently uncertain, especially in light of the Company’s limited operating history. These and other important factors discussed under the caption “Risk Factors” in the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (the “SEC”) on March 25, 2021 and its other filings with the SEC could cause actual results to differ materially and adversely from those indicated by the forward-looking statements made in this presentation. While the Company may elect to update such forward-looking statements at some point in the future, it disclaims any obligation to do so, even if subsequent events cause its views to change. This presentation includes information related to market opportunity as well as cost and other estimates obtained from internal analyses and external sources. The internal analyses are based upon management’s understanding of market and industry conditions and have not been verified by independent sources. Similarly, the externally sourced information has been obtained from sources the Company believes to be reliable, but the accuracy and completeness of such information cannot be assured. Neither the company, nor any of its respective officers, directors, managers, employees, agents, or representatives, (i) make any representations or warranties, express or implied, with respect to any of the information contained herein, including the accuracy or completeness of this presentation or any other written or oral information made available to any interested party or its advisor (and any liability therefore is expressly disclaimed), (ii) have any liability from the use of the information, including with respect to any forward-looking statements, or (iii) undertake to update any of the information contained herein or provide additional information as a result of new information or future events or developments. 2Legal 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 statements. Forward-looking statements use words like “believes,” “plans,” “expects,” “intends,” “will,” “would,” “anticipates,” “estimates,” and similar words or expressions in discussions of the Company’s future operations, financial performance or the Company’s strategies. These statements are based on current expectations or objectives that are inherently uncertain, especially in light of the Company’s limited operating history. These and other important factors discussed under the caption “Risk Factors” in the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (the “SEC”) on March 25, 2021 and its other filings with the SEC could cause actual results to differ materially and adversely from those indicated by the forward-looking statements made in this presentation. While the Company may elect to update such forward-looking statements at some point in the future, it disclaims any obligation to do so, even if subsequent events cause its views to change. This presentation includes information related to market opportunity as well as cost and other estimates obtained from internal analyses and external sources. The internal analyses are based upon management’s understanding of market and industry conditions and have not been verified by independent sources. Similarly, the externally sourced information has been obtained from sources the Company believes to be reliable, but the accuracy and completeness of such information cannot be assured. Neither the company, nor any of its respective officers, directors, managers, employees, agents, or representatives, (i) make any representations or warranties, express or implied, with respect to any of the information contained herein, including the accuracy or completeness of this presentation or any other written or oral information made available to any interested party or its advisor (and any liability therefore is expressly disclaimed), (ii) have any liability from the use of the information, including with respect to any forward-looking statements, or (iii) undertake to update any of the information contained herein or provide additional information as a result of new information or future events or developments. 2


Harmony’s Strategy for Growth Expand Optimize Acquire ® WAKIX Clinical New Commercial Utility of Assets Launch WAKIX 3Harmony’s Strategy for Growth Expand Optimize Acquire ® WAKIX Clinical New Commercial Utility of Assets Launch WAKIX 3


Q2 2021 WAKIX Revenue Performance Continued Growth with Q2 Revenue of $73.8M $73.8 2Q21 2Q21 2Q20 1Q21 2Q21 vs. vs. $59.7 1Q21 2Q20 $56.3 $38.0 $59.7 $73.8 23.6% 94% $45.6 $38.0 Strong Revenue Growth in Q2 2021 § 23.6% growth Q2 2021 vs. Q1 2021 $19.8 § Over 90% growth Q2 2021 vs. Q2 2020 § Continued sequential quarter over $6.0 quarter growth from launch Q4 2019 Q1 2020 Q2 2020 Q3 2020 Q4 2020 Q1 2021 Q2 2021 WAKIX Net Revenue ($m) 4Q2 2021 WAKIX Revenue Performance Continued Growth with Q2 Revenue of $73.8M $73.8 2Q21 2Q21 2Q20 1Q21 2Q21 vs. vs. $59.7 1Q21 2Q20 $56.3 $38.0 $59.7 $73.8 23.6% 94% $45.6 $38.0 Strong Revenue Growth in Q2 2021 § 23.6% growth Q2 2021 vs. Q1 2021 $19.8 § Over 90% growth Q2 2021 vs. Q2 2020 § Continued sequential quarter over $6.0 quarter growth from launch Q4 2019 Q1 2020 Q2 2020 Q3 2020 Q4 2020 Q1 2021 Q2 2021 WAKIX Net Revenue ($m) 4


Driving Growth Through Our Launch For WAKIX Q2 2021 Performance Increased Access to HCPs Average # of ~3,200 WAKIX Patients Patient Outreach Programs & Support Of 8,000 unique HCPs have >37% prescribed WAKIX since launch Healthcare Professional Educational Initiatives U.S. Covered Lives With Formulary Access ~80% Managed Care Education & Outreach 5Driving Growth Through Our Launch For WAKIX Q2 2021 Performance Increased Access to HCPs Average # of ~3,200 WAKIX Patients Patient Outreach Programs & Support Of 8,000 unique HCPs have >37% prescribed WAKIX since launch Healthcare Professional Educational Initiatives U.S. Covered Lives With Formulary Access ~80% Managed Care Education & Outreach 5


Core Attributes of WAKIX Product Profile Align with Existing Unmet Needs in Narcolepsy Top Unmet Needs in Narcolepsy * WAKIX (pitolisant) (cited by patients and HCPs) Need for non-scheduled treatment options First and only FDA approved (low/no abuse potential) non-scheduled treatment option for narcolepsy Need for more tolerable treatment Established Safety Profile regimens No Boxed Warning, no REMS Program Need for more effective treatment options Statistically significant reduction in EDS and cataplexy demonstrated in two Phase III trials Novel MOAs beyond currently available First-in-class molecule with a novel MOA; therapies needed H R antagonist/inverse agonist; works 3 through histamine Need for less frequently dosed products; Convenient, once daily dosing in the need for once-daily options morning upon wakening * Based on FDA approved product labeling Source: Harmony ATU, July 2018 (n=286); Versta Research, Know Narcolepsy Survey (“Know Narcolepsy”), October 2018 6 In descending order of importance as stated by combined HCP and patient audience


Harmony Development Pipeline 7Harmony Development Pipeline 7


Control Centers for Sleep-Wake Centered in the Hypothalamus (HT) • Main mediators of wakefulness and sleep/wake state stability: • orexin/hypocretin (produced in the Cortex lateral HT) • histamine (produced in the TMN, Prefrontal Cortex also located in the HT) Orexin/ MCH Hypocretin BF (ACh/GABA) • Main driver of NREM sleep: • GABA (produced in the VLPO in the VLPO LDT/PPT VTA (GABA) (ACh) (DA) HT) Raphe (5-HT) TMN LC (NE) (Histamine) SLD (Glutamate) • Main generator of REM sleep: • Melanin concentration hormone Spinal motor neuron (MCH) (produced in a diffuse s network of neurons in the lateral HT Wake-promoting NREM Sleep-promoting interspersed amongst the orexin REM Sleep-promoting neurons) 8Control Centers for Sleep-Wake Centered in the Hypothalamus (HT) • Main mediators of wakefulness and sleep/wake state stability: • orexin/hypocretin (produced in the Cortex lateral HT) • histamine (produced in the TMN, Prefrontal Cortex also located in the HT) Orexin/ MCH Hypocretin BF (ACh/GABA) • Main driver of NREM sleep: • GABA (produced in the VLPO in the VLPO LDT/PPT VTA (GABA) (ACh) (DA) HT) Raphe (5-HT) TMN LC (NE) (Histamine) SLD (Glutamate) • Main generator of REM sleep: • Melanin concentration hormone Spinal motor neuron (MCH) (produced in a diffuse s network of neurons in the lateral HT Wake-promoting NREM Sleep-promoting interspersed amongst the orexin REM Sleep-promoting neurons) 8


Orexin and MCH: Opposing Roles in the Hypothalamus Related to Sleep-Wake Function In NT1 with orexin deficiency: Original model of narcolepsy: • imbalance between orexin and MCH, the • imbalance between orexin and GABA, REM generator the NREM sleep generator • MCH goes unchecked causing REM • GABA goes unchecked resulting in sleep intrusion into wakefulness (cataplexy, intruding into wakefulness (EDS) hallucinations, sleep paralysis) MCH GABA/ neuron VLPO HBS-102 therapeutic hypothesis: • MCH activity goes unchecked in the setting of orexin deficiency (NT1) • HBS-102, an MCHR1 antagonist, will potentially: • restore balance between MCH and orexin signaling • decrease REM overdrive à decrease REM intrusions into wakefulness à decrease the symptoms of cataplexy, hallucinations and sleep paralysis Orexin HBS- MCH neuron neuron 102 9 Ferreira, et al, 2017; Gonzalez et al, 2016; Slide adapted from T. ScammellOrexin and MCH: Opposing Roles in the Hypothalamus Related to Sleep-Wake Function In NT1 with orexin deficiency: Original model of narcolepsy: • imbalance between orexin and MCH, the • imbalance between orexin and GABA, REM generator the NREM sleep generator • MCH goes unchecked causing REM • GABA goes unchecked resulting in sleep intrusion into wakefulness (cataplexy, intruding into wakefulness (EDS) hallucinations, sleep paralysis) MCH GABA/ neuron VLPO HBS-102 therapeutic hypothesis: • MCH activity goes unchecked in the setting of orexin deficiency (NT1) • HBS-102, an MCHR1 antagonist, will potentially: • restore balance between MCH and orexin signaling • decrease REM overdrive à decrease REM intrusions into wakefulness à decrease the symptoms of cataplexy, hallucinations and sleep paralysis Orexin HBS- MCH neuron neuron 102 9 Ferreira, et al, 2017; Gonzalez et al, 2016; Slide adapted from T. Scammell


Pre-clinical POC for MCHR1 Antagonism SLREM: short latency transitions into REM sleep (a feature of NT1) 1. Naganuma et al, NeurobiolDis. 2018; 120, 12. 10 2. Oshio et al. J of NeuroScience. 2013:33;9743.Pre-clinical POC for MCHR1 Antagonism SLREM: short latency transitions into REM sleep (a feature of NT1) 1. Naganuma et al, NeurobiolDis. 2018; 120, 12. 10 2. Oshio et al. J of NeuroScience. 2013:33;9743.


HBS-102: Next Steps ¾ Demonstrate preclinical POC with HBS-102 in orexin knockout mouse model ¾ Prepare IND then submit to FDA ¾ Initiate Phase 2a proof of concept study once IND opens Become a leading rare neurological disease company with an innovative product portfolio Committed to advancing breakthrough science and addressing unmet medical needs 11HBS-102: Next Steps ¾ Demonstrate preclinical POC with HBS-102 in orexin knockout mouse model ¾ Prepare IND then submit to FDA ¾ Initiate Phase 2a proof of concept study once IND opens Become a leading rare neurological disease company with an innovative product portfolio Committed to advancing breakthrough science and addressing unmet medical needs 11


Strategic Financing Collaboration $330M of financing and growth capital from Blackstone enables Harmony to expand portfolio of assets in rare, neurological diseases Benefits to Harmony Debt to payoff existing debt $200M facility • Strengthens balance sheet • Access to additional capital to acquire complementary assets to Cash available for drawdown build our product pipeline $100M within 12 months • Lower interest cost - reduces annual interest expense by ~$10M • Equity investment from premier, Equity investment in common global investment firm with leading $30M stock life sciences capabilities 12Strategic Financing Collaboration $330M of financing and growth capital from Blackstone enables Harmony to expand portfolio of assets in rare, neurological diseases Benefits to Harmony Debt to payoff existing debt $200M facility • Strengthens balance sheet • Access to additional capital to acquire complementary assets to Cash available for drawdown build our product pipeline $100M within 12 months • Lower interest cost - reduces annual interest expense by ~$10M • Equity investment from premier, Equity investment in common global investment firm with leading $30M stock life sciences capabilities 12


Q2 2021 Financial Summary (in millions, USD) Three Months Ended June 30, 2021 2020 Net Product Revenues $ 73.8 $ 38.0 Cost of Product Sold 12.7 6.4 Total Operating Expenses $ 37.8 $ 24.2 R&D Expense 6.5 4.2 S&M Expense 17.0 12.4 G&A Expense 14.3 7.6 Net Income available to common $ 14.1 $ (10.5) stockholders (Loss) Cash & cash equivalents $ 159.7 Totals may not foot due to rounding 13Q2 2021 Financial Summary (in millions, USD) Three Months Ended June 30, 2021 2020 Net Product Revenues $ 73.8 $ 38.0 Cost of Product Sold 12.7 6.4 Total Operating Expenses $ 37.8 $ 24.2 R&D Expense 6.5 4.2 S&M Expense 17.0 12.4 G&A Expense 14.3 7.6 Net Income available to common $ 14.1 $ (10.5) stockholders (Loss) Cash & cash equivalents $ 159.7 Totals may not foot due to rounding 13


GAAP vs Non-GAAP Reconciliation (in millions, USD) Three Months Ended June 30, 2021 2020 GAAP reported net income (loss) $ 14.1 $ (0) Interest expense / income 7.2 6.9 Taxes 2.0 Depreciation 0.1 0.1 Amortization 4.6 1.9 EBITDA 28.0 8.9 Stock-based compensation expense 3.8 0.6 Loss on debt extinguishment Warrant expense 0.4 Non-GAAP adjusted net income (loss) 31.9 9.9 Accumulation of yield on preferred stock (10.4) Non-GAAP adjusted net income (loss) available to $ 31.9 $ (0.5) common stockholders GAAP reported net loss per diluted share $ 0.24 $ (1.34) Non-GAAP adjusted net income (loss) per diluted share $ 0.54 $ (0.07) Weighted average number of shares of common stock used in 58,592,876 7,805,848 non-GAAP diluted per share Totals may not foot due to rounding 14GAAP vs Non-GAAP Reconciliation (in millions, USD) Three Months Ended June 30, 2021 2020 GAAP reported net income (loss) $ 14.1 $ (0) Interest expense / income 7.2 6.9 Taxes 2.0 Depreciation 0.1 0.1 Amortization 4.6 1.9 EBITDA 28.0 8.9 Stock-based compensation expense 3.8 0.6 Loss on debt extinguishment Warrant expense 0.4 Non-GAAP adjusted net income (loss) 31.9 9.9 Accumulation of yield on preferred stock (10.4) Non-GAAP adjusted net income (loss) available to $ 31.9 $ (0.5) common stockholders GAAP reported net loss per diluted share $ 0.24 $ (1.34) Non-GAAP adjusted net income (loss) per diluted share $ 0.54 $ (0.07) Weighted average number of shares of common stock used in 58,592,876 7,805,848 non-GAAP diluted per share Totals may not foot due to rounding 14


Thank You August 10, 2021Thank You August 10, 2021