Harmony Biosciences(US:HRMY)2021-05-11 12:15Financial 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]