Puma Biotechnology Inc 2025年季度报告

in Rule 12b-2 of the Exchange Act. If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new orrevised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).Yes☐No☒.Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.49,638,093shares of CommonStock, par value $0.0001 per share, were outstanding as ofMay 5, 2025. PART I–FINANCIAL INFORMATION: Condensed Consolidated Balance Sheets as of March 31, 2025 and December 31, 2024Condensed Consolidated Statements of Operations for the Three Months Ended March 31, 2025 and 2024Condensed Consolidated Statements of Comprehensive Income for the Three Months Ended March 31, 2025 and 2024 Notes to the Unaudited Condensed Consolidated Financial StatementsManagement’s Discussion and Analysis of Financial Condition and Results of Operations Controls and ProceduresPART II–OTHER INFORMATION: Risk FactorsUnregistered Sales of Equity Securities and Use of Proceeds •the regulatory approval of our drug candidates; •our ability to find collaborative partners for research, development and commercialization of potential products; •efforts of our sub-licensees to obtain regulatory approval and commercialize NERLYNX in areas outside the United States;•our ability to market any of our products; •our anticipated capital requirements and estimates regarding our needs for additional financing; •our ability to compete against other companies and research institutions; •our ability to in-license additional drugs; •our ability to attract and retain key personnel; and •our ability to obtain adequate financing on favorable terms or at all. “project,” “continuing,” “ongoing,” “expect,” “believe,” “intend” and similar words or phrases. Accordingly, these statements involveestimates, assumptions and uncertainties that could cause actual results to differ materially from those expressed in them. Discussions Management’s Discussion and Analysis of Financial Condition and Results of Operations.” These forward-looking statements involve risksand uncertainties, including the risks discussed in Part I, Item 1A. “Risk Factors” of our Annual Report on Form 10-K for the year endedDecember 31, 2024, and this Quarterly Report on Form 10-Q, that could cause our actual results to differ materially from those in theforward-looking statements. Such risks should be considered in evaluating our prospects and future financial performance. We undertake no CONDENSED CONSOLIDATED BALANCE SHEETS(in thousands, except share and per share data) (unaudited)March 31, 2025December 31,2024Current assets:Cash and cash equivalents$63,030$Marketable securities30,137 Investing activities:Purchase of property and equipment Payment of debtPayment of exit costs Net cash used in financing activitiesNet decrease in cash, cash equivalents and restricted cash Cash, cash equivalents and restricted cash, end of period65,121Supplemental disclosure of cash flow information:Interest paid$1,917$Income taxes paid$101$ Business and Liquidity: commercializing NERLYNX®, an oral version of neratinib (“NERLYNX”), for the treatment ofHER2-positivebreast cancer. Additionally,the Company in-licensed, and is responsible for the global development and commercialization of, alisertib. Alisertib is a selective, small Aurora Kinase. The Company believes alisertib has potential application in the treatment of a range of different cancer types, includinghormone receptor positive breast cancer, triple-negative breast cancer andsmall cell lung cancer.The Company hasonesubsidiary,Puma Biotechnology, B.V., a Netherlands company. This subsidiary wasestablished for the purposeof legal representation inthe European Union (“EU”).The condensed consolidated financial statements include the accounts of the Company cannot assure that we will continue to do so and will need to continue to generate significant revenue to sustain operations and successfullycommercialize neratinib.In2017,the Company received U.S. Food and Drug Administration (“FDA”)approval for itsfirstproduct,NERLYNX®(neratinib), formerly known asPB272(neratinib, oral), for the extended adjuvant treatment of adult patients with earlystageHER2-overexpressed/amplified breast cancer following adjuvant trastuzumab-based therapy.Following FDA approval in July2017,NERLYNX became available by prescription in the United States, and the Company commenced commercialization.InFebruary 2020,NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients withadvanced or metastaticHER2-positive breast cancer who have receivedtwoor more prior anti-HER2-based regimens in the metastatic setting.In2018,the European Commission (“EC”)granted marketing