Puma Biotechnology(PBYI) - 2024 Q1 - Quarterly Report

Financial Performance - Total revenue for Q1 2024 was $43,766,000, a decrease of 17.1% compared to $52,775,000 in Q1 2023[16] - Product revenue decreased to $40,279,000 in Q1 2024 from $46,794,000 in Q1 2023, representing a decline of 13.9%[16] - Net loss for Q1 2024 was $4,815,000, compared to a net income of $1,401,000 in Q1 2023, indicating a significant shift in financial performance[18] - Royalty revenue for the three months ended March 31, 2024, was $3.5 million, compared to $6.0 million for the same period in 2023, reflecting a decrease of approximately 41.7%[65] - Total revenue for Q1 2024 was approximately $43.8 million, a decrease from $52.8 million in Q1 2023, primarily due to a $6.5 million decrease in product revenue and a $2.5 million decrease in royalty revenue[191] Cash Flow and Liquidity - Cash and cash equivalents decreased to $76,751,000 as of March 31, 2024, down from $84,585,000 at the end of 2023[14] - The company reported a net cash provided by operating activities of $11,246,000 for Q1 2024, compared to $2,643,000 in Q1 2023, showing improved cash flow from operations[23] - Cash provided by operations was approximately $11.2 million for the three months ended March 31, 2024, with total cash and cash equivalents and marketable securities amounting to approximately $107.2 million[31] - Cash used in investing activities was approximately $19.1 million in Q1 2024, compared to $17.5 million in Q1 2023, primarily for the purchase of available-for-sale securities[203] - As of March 31, 2024, cash and cash equivalents were $76.8 million, down from $84.6 million as of December 31, 2023[200] Assets and Liabilities - Total assets decreased to $214,149,000 as of March 31, 2024, compared to $230,528,000 at the end of 2023, reflecting a reduction of 7.1%[14] - Total liabilities decreased to $163,167,000 as of March 31, 2024, down from $177,086,000 at the end of 2023, a decline of 7.8%[14] - Total accounts receivable decreased from $48.7 million as of December 31, 2023, to $25.6 million as of March 31, 2024, representing a decline of approximately 47.4%[111] - Accrued expenses decreased from $52.8 million as of December 31, 2023, to $37.8 million as of March 31, 2024, a reduction of about 28.4%[124] - Total long-term debt, net, is reported at $54.7 million as of March 31, 2024, after accounting for debt issuance costs and current portion[127] Research and Development - Research and development expenses increased to $13,587,000 in Q1 2024 from $12,706,000 in Q1 2023, an increase of 6.9%[16] - R&D expenses increased to approximately $13.6 million in Q1 2024, up 6.9% from $12.7 million in Q1 2023, driven by a 39.9% increase in clinical trial expenses[197] - The company is commercializing NERLYNX® for HER2-positive breast cancer and has recently in-licensed alisertib for global development and commercialization[24] - The company initiated the ALISCA-Lung1 Phase II trial for alisertib in February 2024 and plans to commence the ALISCA-Breast 1 trial in the second half of 2024[176] - Research and development expenses include clinical manufacturing costs, clinical trial expenses, and consulting costs, with payments dependent on achieving certain milestones[67] Stock and Compensation - The weighted-average shares of common stock outstanding increased to 48,189,256 in Q1 2024 from 46,636,083 in Q1 2023, reflecting an increase of 3.3%[16] - Total stock-based compensation expense for the three months ended March 31, 2024 was $2.377 million, compared to $2.838 million for the same period in 2023[141] - As of March 31, 2024, 4,776,926 stock options were outstanding with a weighted average exercise price of $46.54[142] - The total estimated unrecognized employee compensation cost related to non-vested stock options was approximately $2.7 million, expected to be recognized over 1.4 years[142] - The weighted average grant date fair value of options granted during the three months ended March 31, 2024 was $4.57 per share[142] Legal and Regulatory Matters - The Company is involved in multiple legal proceedings, including a lawsuit against AstraZeneca for patent infringement, with a jury trial scheduled for May 13, 2024[156] - The Company has filed lawsuits against Acebright and Aosaikang in China for patent infringement related to its NERLYNX product, with ongoing appeals and administrative determinations[158][161] - The Company can terminate the license agreement with Pfizer at will or for safety concerns, with specified advance notice[150] - The Company has the right to enforce its patents in civil litigation in China against generic competitors[161] - The CNIPA declined to accept the company's request for administrative determination regarding certain patents, stating they are not eligible for registration in the Chinese Orange Book[167] Future Obligations and Milestones - The Company has significant contractual obligations to make payments to Pfizer upon achieving certain milestones related to NERLYNX[28] - The Company is obligated to make milestone payments totaling approximately $187.5 million upon achieving certain milestones, with a one-time payment of $12.5 million triggered by worldwide net sales of $250 million in 2022[150] - As of March 31, 2024, the total potential milestone payments due to the Company upon achievement of all respective performance obligations under the sub-license agreements is approximately $579.8 million[63] - Future minimum lease payments as of March 31, 2024, total $11.9 million, with the largest payment of $5.98 million due in 2025[118] - Future minimum principal and exit payments under the Athyrium Notes total $102.0 million, with $33.997 million due in 2024, $45.329 million in 2025, and $22.674 million in 2026[133]