Puma Biotechnology, Inc. (PBYI) reported second-quarter 2024 adjusted loss of 5 cents per share, which was narrower than the Zacks Consensus Estimate of a loss of 10 cents. In the year-ago quarter, the company had reported adjusted earnings of 10 cents. The above-adjusted loss excludes the impact of stock-based compensation expense. Including the same, the reported loss per share was 9 cents in the second quarter of 2024 against earnings of 5 cents reported in the year-ago quarter. In the second quarter, to ...

Puma Biotechnology Earnings Call Commercial Update August 1, 2024 Forward-Looking Safe-Harbor Statement This presentation contains forward-looking statements, including statements regarding commercialization of NERLYNX® and the potential indications and development of our drug candidates. All forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These sta ...

Puma Biotech (PBYI) came out with a quarterly loss of $0.05 per share versus the Zacks Consensus Estimate of a loss of $0.10. This compares to earnings of $0.10 per share a year ago. These figures are adjusted for nonrecurring items. This quarterly report represents an earnings surprise of 50%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $0.16 per share when it actually produced a loss of $0.05, delivering a surprise of 68.75%. Over the last four quarters, the com ...

Financial 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]

Here at Zacks, our focus is on the proven Zacks Rank system, which emphasizes earnings estimates and estimate revisions to find great stocks. Nevertheless, we are always paying attention to the latest value, growth, and momentum trends to underscore strong picks. Puma Biotechnology (PBYI) is a stock many investors are watching right now. PBYI is currently sporting a Zacks Rank of #2 (Buy), as well as an A grade for Value. Finally, investors will want to recognize that PBYI has a P/CF ratio of 6.55. This met ...

Shares of Puma Biotechnology, Inc. (PBYI) have plunged 38.4% in the past three months compared with the industry's decline of 4.8%. The company's sole marketed product, Nerlynx (neratinib), is approved for the treatment of early-stage HER2- positive breast cancer in patients who have been previously treated with Roche's (RHHBY) Herceptin-based adjuvant therapy. Demand for Nerlynx has been declining in recent quarters. Owing to this, sales of the drug have been falling over the past couple of quarters. Being ...

Puma Biotechnology, Inc. (NASDAQ:PBYI) Q1 2024 Earnings Conference Call May 2, 2024 4:30 PM ET Company Participants Mariann Ohanesian – Senior Director-Investor Relations Alan Auerbach – Chief Executive Officer, President and Chairman of the Board Jeff Ludwig – Chief Commercial Officer Maximo Nougues – Chief Financial Officer Conference Call Participants Ed White – H.C. Wainwright Divya Rao – TD Cowen Operator Good afternoon. My name is Camilla, and I will be your conference call operator today. At this tim ...

Forward-Looking Safe-Harbor Statement Patients Sites of Care Academic Hospitals Community Hospitals Physician Practices Others (VA, DOD) Hub Services Specialty Pharmacy Network (SP) Specialty Distributor Network (SD) Acaria Health Accredo CVS ONCO360 Optum / Diplomat Biologics Cardinal Health McKesson ASD / Oncology Supply DMS Pharmaceutical Group Inc. Q1'2023 Q1'2024 +$2.1 mil -$2.0 mil Net Revenue (in $MM) Q1'2023 Q1'2024 +127 -120 2,881 2,410 Q4'2023 Q1'2024 Bottles ~67% of Patients in Q1'24 Started at a ...

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]

Exhibit 99.1 LOS ANGELES, Calif., May 2, 2024 - Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced financial results for the first quarter ended March 31, 2024. Unless otherwise stated, all comparisons are for the first quarter 2024 compared to the first quarter 2023. Product revenue, net consists entirely of revenue from sales of NERLYNX®, Puma's first commercial product. Product revenue, net in the first quarter of 2024 was $40.3 million, compared to product revenue, net of $4 ...