Puma Biotechnology(US:PBYI)2024-08-01 20:41Financial Performance - Total revenue for Q2 2024 was $47.083 million, a decrease of 13.8% compared to $54.568 million in Q2 2023[9] - Product revenue, net for Q2 2024 was $44.395 million, down from $51.551 million in Q2 2023, representing a decline of 13.3%[9] - Net loss for Q2 2024 was $4.529 million, compared to a net income of $2.126 million in Q2 2023, indicating a significant shift in financial performance[10] - Comprehensive loss for Q2 2024 was $4.535 million, compared to a comprehensive income of $2.120 million in Q2 2023[10] - The company reported a net loss of approximately $9.3 million for the six months ended June 30, 2024, compared to a net income of $3.5 million for the same period in 2023[23] - Total revenue for the six months ended June 30, 2024, was approximately $90.8 million, down from $107.3 million for the same period in 2023, primarily due to a $13.7 million decrease in product revenue[171] - Product revenue, net decreased by approximately 16.1% to $84.7 million for the six months ended June 30, 2024, compared to $98.3 million for the same period in 2023[172] Operating Costs and Expenses - Operating costs and expenses totaled $49.262 million in Q2 2024, slightly down from $49.676 million in Q2 2023[9] - Total operating costs and expenses for the first half of 2024 were $95.327 million, down from $98.086 million in the same period of 2023[9] - SG&A expenses increased by approximately $0.5 million to $25.0 million for the three months ended June 30, 2024, compared to $24.5 million for the same period in 2023, primarily due to a $2.7 million increase in professional fees[165] - SG&A expenses for the six months ended June 30, 2024, were approximately $46.7 million, a slight decrease from $46.9 million for the same period in 2023[174] Research and Development - Research and development expenses were $13.632 million in Q2 2024, compared to $13.357 million in Q2 2023, reflecting a 2% increase[9] - R&D expenses rose by approximately $0.3 million to $13.6 million for the three months ended June 30, 2024, compared to $13.4 million for the same period in 2023, mainly driven by a $0.5 million increase in internal R&D[166] - R&D expenses for the six months ended June 30, 2024, were approximately $27.2 million, up from $26.1 million for the same period in 2023, driven by a $0.9 million increase in clinical trial expenses[176] Cash and Liquidity - Cash provided by operating activities was approximately $12.3 million for the six months ended June 30, 2024, up from $5.9 million in the prior year[23] - The company had cash, cash equivalents, and marketable securities totaling approximately $96.8 million as of June 30, 2024[23] - Cash and cash equivalents as of June 30, 2024, were approximately $67.1 million, down from $84.6 million as of December 31, 2023[179] - The company has approximately $67.1 million in cash and cash equivalents and $29.7 million in marketable securities available as of June 30, 2024[191] Debt and Financing - Long-term debt as of June 30, 2024, totals $102,000,000, with a net amount of $43,735,000 after accounting for issuance costs and current portion[108] - The effective interest rate for the Athyrium Notes as of June 30, 2024, is 12.99%, with quarterly principal payments approximating $11.1 million[112] - The principal balance outstanding under the Athyrium Notes as of June 30, 2024 was $88.9 million, representing all of the company's debt[190] - The company is in compliance with all applicable covenants under the Athyrium Notes[190] Product Development and Commercialization - The company has entered into an exclusive license agreement with Takeda for the worldwide research and development rights to alisertib[22] - The company is commercializing NERLYNX® for HER2-positive breast cancer and has plans for further commercialization in various regions outside the United States[22] - NERLYNX is currently approved in over 40 countries outside the United States for treating certain patients with HER2-positive breast cancer[152] - The company plans to initiate the ALISCA™ -Breast1 trial in the second half of 2024, following the ALISCA™ -Lung1 trial commenced in February 2024[153] Legal Matters - The jury awarded Wyeth $107,500,000 for past acts of infringement through December 31, 2023, in the AstraZeneca litigation[136] - The Company filed a civil lawsuit against Acebright for infringement of the '789 patent, seeking to enjoin Acebright's offer for sale of a generic version of NERLYNX®[139] - The NMPA approved Acebright's ANDA to market a generic version of NERLYNX® in China on September 12, 2023[138] - The Company has filed four Article 76 petitions against Convalife's ANDA with CNIPA, which were accepted on February 3, 2023[144] Inventory and Accounts Receivable - As of June 30, 2024, total inventories increased to $9,049,000 from $7,080,000 as of December 31, 2023, representing a 27.8% increase[83] - The company's accounts receivable, net decreased to $28,105,000 as of June 30, 2024, down from $47,837,000 as of December 31, 2023, a decline of 41.2%[96] Stock and Compensation - The company issued 813,333 shares of common stock upon vesting of RSUs during the six months ended June 30, 2024[118] - Total stock-based compensation expense for the three months ended June 30, 2024 was $2,062,000, compared to $2,432,000 for the same period in 2023[123] - The total estimated unrecognized employee compensation cost related to non-vested stock options was approximately $1.8 million, expected to be recognized over a weighted-average period of 1.3 years[124]