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(HRMY) - 2021 Q2 - Earnings Call Transcript