Puma Biotechnology(PBYI) - 2023 Q1 - Quarterly Report

Financial Performance - Total revenue for Q1 2023 was $52.775 million, a 15.4% increase from $45.736 million in Q1 2022[17] - Product revenue increased to $46.794 million in Q1 2023, up from $40.718 million in Q1 2022, representing a 15.1% growth[17] - Net income for Q1 2023 was $1.401 million, compared to a net loss of $3.403 million in Q1 2022[18] - Royalty revenue for the three months ended March 31, 2023, was $6.0 million, compared to $5.0 million for the same period in 2022, reflecting a 20% increase[66] - Total revenue for Q1 2023 was approximately $52.8 million, an increase of 15.4% from $45.7 million in Q1 2022, driven by a $6.1 million increase in product sales and a $1.0 million increase in royalty revenue[193] - Product revenue, net was approximately $46.8 million for Q1 2023, up 15.0% from $40.7 million in Q1 2022, attributed to a 6.3% increase in bottles of NERLYNX sold and higher net selling prices[194] Cash and Liquidity - Cash and cash equivalents decreased to $61.394 million as of March 31, 2023, down from $76.201 million at the end of 2022[15] - The Company had cash and cash equivalents and marketable securities totaling approximately $71.2 million as of March 31, 2023[32] - Cash flows provided by operations were approximately $2.6 million for the three months ended March 31, 2023[32] - The company reported approximately $62.8 million in cash and cash equivalents exceeding insured limits as of March 31, 2023, indicating a concentration of credit risk[88] - The company intends to satisfy near-term liquidity requirements through existing cash and cash equivalents, marketable securities, and proceeds from product sales[181] Expenses and Costs - Research and development expenses for Q1 2023 were $12.706 million, down from $15.237 million in Q1 2022, a decrease of 16.6%[17] - SG&A expenses increased to approximately $22.5 million in Q1 2023, a 10.2% rise from $20.4 million in Q1 2022, mainly due to higher payroll costs and increased travel expenses[197] - Cost of sales rose to approximately $13.2 million in Q1 2023, up from $10.8 million in Q1 2022, primarily due to higher royalty expenses and increased intangible amortization related to a $12.5 million milestone payment to Pfizer[196] - Stock-based compensation expense for the three months ended March 31, 2023, was $2.838 million, compared to $3.148 million for the same period in 2022[143] Assets and Liabilities - Total assets decreased to $196.257 million as of March 31, 2023, from $222.059 million at the end of 2022[15] - Total liabilities decreased to $170.410 million as of March 31, 2023, from $200.451 million at the end of 2022[15] - The company has total long-term debt of $98.62 million as of March 31, 2023, which includes a $2.0 million exit payment[126] - Total accounts receivable decreased from $40.35 million as of December 31, 2022, to $31.16 million as of March 31, 2023, representing a decline of approximately 22.8%[108] Product Development and Commercialization - The company is currently commercializing NERLYNX for HER2+ breast cancer and has in-licensed alisertib for global development[24] - NERLYNX was approved by the FDA in July 2017 for the treatment of early stage HER2-overexpressed breast cancer and has since been commercialized in the U.S.[26] - The Company plans to continue pursuing commercialization of NERLYNX in various international markets, including Europe, Australia, and China[30] - The Company entered into an exclusive license agreement with Takeda for the worldwide research and development rights to alisertib in September 2022[31] - The company has invested significantly in the development and commercialization of its lead product, NERLYNX, which is expected to constitute the majority of product revenue for the foreseeable future[90] Legal and Regulatory Matters - The company filed a lawsuit against AstraZeneca for patent infringement, with trial currently scheduled to begin on or after May 13, 2024[159] - The company settled a patent infringement litigation with Sandoz, allowing Sandoz to sell a generic version of neratinib on or around December 8, 2030[161] - The company has filed petitions against ANDAs from Acebright, Aosaikang, Convalife, and Kelun, seeking administrative determinations regarding patent claims[165][166][168][171] - The CNIPA has declined to accept certain requests for administrative determination related to patents ZL200880118789.3 and ZL201710057547.9, citing eligibility issues[166][171] Future Outlook and Obligations - The Company has incurred significant operating losses since its inception and remains dependent on its ability to obtain sufficient funding to sustain operations[33] - The company has contractual obligations to make substantial payments to Pfizer upon achieving certain milestones[29] - The company is obligated to make milestone payments totaling approximately $187.5 million upon achieving certain milestones under the Pfizer License Agreement[152] - The company achieved aggregate worldwide net sales of $250.0 million in calendar year 2022, resulting in a payment of $12.5 million to Pfizer during Q1 2023[152]