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]

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 ONCO 360 Optum / Diplomat Biologics Cardinal Health McKesson ASD/Oncology Supply DMS Pharmaceutical Group Inc. 6.1 20.1 36.0 50.8 52.6 61.1 45.6 53.8 53.5 58.7 48.6 48.8 49.3 50.0 45.8 48.9 43.4 51.0 40.7 51.3 54.3 53.7 Bottles Sold (SP + SD) by Quarter ~64% of patients in Q4'22 started at a reduced dose* ...

Puma Biotechnology, Inc. (NASDAQ:PBYI) Q4 2022 Earnings Conference Call March 2, 2023 4:30 PM ET Company Participants Mariann Ohanesian - Senior Director of IR Alan Auerbach - CEO, President and Chairman Maximo Nougues - CFO Jeff Ludwig - Chief Commercial Officer Conference Call Participants Dave Rao - Cowen and Company Sahil Kazmi - B. Riley Securities Operator Good afternoon. My name is Diego, and I will be your conference call operator today. [Operator Instructions] As a reminder, this call is being reco ...

Product Approval and Commercialization - NERLYNX is currently approved in the United States for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed breast cancer and for use in combination with capecitabine for advanced HER2-positive breast cancer [17]. - As of December 31, 2022, NERLYNX has received approval in over 18 countries outside the United States, including the European Union, China, and Canada [19]. - The company relies on a direct sales force of approximately 40 sales specialists to market NERLYNX in the United States [19]. - The company has implemented a managed access program for NERLYNX to provide access to patients in countries with limited therapeutic options [20]. - The company aims to become a leading provider of advanced therapies for cancer treatment, focusing on the commercialization of NERLYNX in the U.S. and pursuing regulatory approvals in additional countries [23]. - NERLYNX was launched in the United States in July 2017, with subsequent approval in February 2020 for use in combination with capecitabine for advanced or metastatic HER2-positive breast cancer [93]. - The company aims to establish NERLYNX as the standard of care by educating healthcare providers and patients, ensuring broad insurance coverage, and providing co-pay support [94]. - NERLYNX received marketing authorization in the EU in August 2018 and was included in China's National Reimbursement Drug List in December 2021, enhancing access for patients [95]. - The company is focused on expanding its commercialization efforts for NERLYNX in Europe and other international markets [95]. Clinical Trials and Efficacy - The ExteNET trial demonstrated a 33% reduction in the risk of invasive disease recurrence or death for patients treated with neratinib compared to placebo, with a two-year disease-free survival (DFS) rate of 93.9% for the neratinib arm [33]. - For centrally confirmed HER2-positive patients, neratinib resulted in a 49% reduction in the risk of invasive disease recurrence or death, with a two-year DFS rate of 94.7% [34]. - The five-year invasive disease-free survival (iDFS) rate for the neratinib arm was 90.2%, compared to 87.7% for the placebo arm, indicating a 27% reduction in risk of recurrence or death [36]. - The NALA trial demonstrated a statistically significant improvement in progression-free survival (PFS) for neratinib plus capecitabine with a hazard ratio of 0.76 (p=0.0059) [55]. - The median overall survival (OS) for patients treated with neratinib plus capecitabine was 21.0 months compared to 18.7 months for lapatinib plus capecitabine [56]. - The NALA trial showed a cumulative incidence of CNS metastases of 22.8% for neratinib plus capecitabine versus 29.2% for lapatinib plus capecitabine (p=0.043) [57]. - The CONTROL trial showed that the incidence of grade 3 diarrhea was 13% for dose escalation regimen 1 (DE1) and 27% for regimen 2 (DE2), significantly lower than the historical control of 39.8% [48]. - The CONTROL trial indicated that the proportion of patients discontinuing neratinib due to diarrhea was 3% for DE1 and 6% for DE2, compared to 17% in the ExteNET trial [48]. Drug Development and Pipeline - The company has in-licensed alisertib, which is designed to disrupt mitosis in rapidly proliferating tumor cells, and plans to develop it for hormone receptor positive breast cancer and small cell lung cancer [21][22]. - Alisertib has shown activity in previous clinical trials across various cancer types, including hormone receptor positive breast cancer and small cell lung cancer, with over 1,300 patients tested in 22 trials prior to licensing [21]. - The company is focused on in-licensing or acquiring additional drug candidates to build a sustainable product pipeline, employing disciplined decision criteria [23]. - The company plans to maximize the value of its programs by evaluating various commercialization strategies for drug candidates, including independent commercialization and collaborative partnerships [23]. - The company anticipates meeting with the FDA in the first half of 2023 to discuss the clinical development plan for alisertib and its potential dosing schedule under Project Optimus [22]. Financial and Business Risks - The company faces risks related to its status as a single product company with limited commercial sales experience, which may hinder its ability to maintain profitability [11]. - The company is dependent on international third-party sub-licensees for the development and commercialization of NERLYNX in several countries, which poses a risk to its business [11]. - The company is obligated to make milestone payments totaling $187.5 million to Pfizer upon achieving certain milestones, with a one-time payment triggered by FDA approval of NERLYNX in July 2017 [112]. - Under the Pfizer Agreement, the company pays annual royalties between approximately 10% and 20% of net sales of licensed products, reduced to a fixed rate in the low to mid-teens as per a 2014 amendment [114]. - The company must use commercially reasonable efforts to develop and commercialize products in specified major-market countries under the Takeda Agreement [117]. Regulatory Environment - The FDA has a goal of ten months to review and act on a standard NDA for a new molecular entity, typically taking twelve months from submission [155]. - The FDA may grant orphan designation to drugs intended for rare diseases affecting fewer than 200,000 individuals in the U.S. [160]. - Orphan products receiving FDA approval are entitled to seven years of exclusivity for the same disease or condition, barring certain exceptions [161]. - The FDA's priority review aims to evaluate applications within six months, compared to ten months for standard reviews [165]. - The EU Clinical Trials Regulation (CTR) harmonizes clinical trial processes across EU member states, effective January 31, 2022 [178]. - The CTR allows for a single application submission for clinical trials across multiple EU member states, streamlining the approval process [179]. - The company is subject to comprehensive regulatory oversight by the EMA and must maintain a pharmacovigilance system for monitoring product safety [188]. Market Competition and Intellectual Property - The company faces significant competition from major pharmaceutical and biotechnology companies, including Genentech, Novartis, and Roche, in the cancer treatment market [88]. - The company holds a worldwide exclusive license for 21 granted U.S. patents and 4 pending U.S. patent applications related to neratinib [97]. - The company is pursuing patent term extensions and supplemental protection certificates in various jurisdictions to enhance its intellectual property protection [99]. - The company holds a worldwide exclusive license for 21 granted U.S. patents and 439 foreign patents related to alisertib, with a focus on developing and commercializing the drug [106]. - The company plans to pursue additional patents for alisertib covering formulations and therapeutic uses, enhancing its intellectual property portfolio [108]. Healthcare Policy and Pricing - Political and regulatory changes in the U.S. healthcare system, such as the ACA, could significantly affect the company's future business operations [203]. - The company may face increased levels of discounts and rebates required by state and federal governments, impacting revenue generation [202]. - The Inflation Reduction Act of 2022 (IRA) requires manufacturers of certain drugs to engage in price negotiations with Medicare starting in 2026, with prices subject to a cap [205]. - The IRA imposes rebates under Medicare Part B and Part D to penalize price increases that exceed inflation, with the first rebates due in 2023 [205]. - The cost of prescription pharmaceuticals in the U.S. remains a significant topic of discussion, with ongoing Congressional inquiries and legislative initiatives aimed at increasing pricing transparency [206].

Financial Data and Key Metrics Changes - Total revenue for Q3 2022 was reported at $57.1 million, with product revenue net of $54.3 million, an increase from $51.3 million in Q2 2022 and $43.4 million in Q3 2021 [7][8] - Net loss based on GAAP for Q3 2022 was $0.4 million or $0.01 per share, compared to a net income of $9.4 million or $0.21 per share in Q2 2022 [28] - Non-GAAP net income for Q3 2022 was $2.5 million or $0.05 per share [29] - Gross to net adjustment in Q3 2022 was about 14.3%, down from 19% in Q2 2022 [30] Business Line Data and Key Metrics Changes - NERLYNX sales included approximately $0.5 million of inventory build in Q3 2022 [8] - New prescriptions (NRx) increased by approximately 17% compared to Q2 2022, while total prescriptions (TRx) were up about 5% [9][22] - Enrollments grew 7% quarter-over-quarter and 12% year-over-year [22] Market Data and Key Metrics Changes - Approximately 80% of NERLYNX business flowed through the specialty pharmacy channel in Q3 2022 [18] - NERLYNX received regulatory approval for metastatic breast cancer in Ecuador and Singapore, and was launched in Brazil and Spain [24] Company Strategy and Development Direction - The company continues to focus on increasing the adoption of NERLYNX through three strategic areas: communicating clinical data, engaging patients, and enhancing field force execution [16] - Puma is evaluating several drugs for potential in-licensing to diversify its portfolio [15] Management Comments on Operating Environment and Future Outlook - Management noted that increased face-to-face interactions with healthcare providers (HCPs) have contributed to improved commercial results [37] - The company anticipates a seasonal decline in new patient starts in Q4 2022 due to the side effect profile of NERLYNX [32] Other Important Information - The company expects net NERLYNX product revenue for fiscal year 2022 to be in the range of $194 million to $196 million [31] - Cash burn for Q3 2022 was approximately $17.4 million, compared to $14 million in Q2 2022 [35] Q&A Session Summary Question: Change in timing for FDA meeting - The timing for the FDA meeting was moved to the first half of 2023 due to delays in submitting the packages [41] Question: Size of the sales team - The current size of the field force is deemed appropriate, with adjustments possible if access continues to improve [42][43] Question: Drivers of good commercial quarter - Increased live interactions with clinicians and improved access due to reduced COVID restrictions contributed to the positive commercial quarter [47][48] Question: Payer split and patient compliance - The payer split is approximately 65% commercial and 25% government, with dose escalation showing a 5% to 7% benefit in decreased discontinuations [54] Question: FDA discussion regarding alisertib - The company plans to proceed with the FDA discussions regardless of the availability of biomarker data [55]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-35703 PUMA BIOTECHNOLOGY, INC. (Exact name of registrant as specified in its charter) Delaware 77-0683487 (State or ...

Financial Data and Key Metrics Changes - Puma reported total revenue for Q2 2022 of $59.5 million, which includes product revenue net of $51.3 million, an increase from $40.7 million in Q1 2022 and $48.9 million in Q2 2021 [9][10] - Net income based on GAAP for Q2 2022 was $9.4 million or $0.21 per share, compared to a net loss of $3.4 million or $0.08 per share in Q1 2022 [45] - Gross revenue from NERLYNX sales was $63.4 million in Q2 2022, up from $51.5 million in Q1 2022 [46] Business Line Data and Key Metrics Changes - NERLYNX sales included approximately $2.7 million on inventory build at specialty pharmacies and distributors in Q2 2022 [9] - The company sold 3,200 bottles of NERLYNX in Q2 2022, an increase of 520 from Q1 2022 [11][32] - New prescriptions (NRx) were down approximately 8% compared to Q1, while total prescriptions (TRX) were up about 1.6% [11] Market Data and Key Metrics Changes - Approximately 79% of NERLYNX business went through the specialty pharmacy channel in Q2 2022, slightly down from 81% in Q1 2022 [29] - The extended adjuvant breast cancer market remains significantly under-penetrated, indicating potential growth opportunities [27] Company Strategy and Development Direction - The company remains focused on leveraging positive clinical data for NERLYNX, engaging patients, and enhancing field force execution [25] - Puma is evaluating several drugs for potential in-licensing to diversify its portfolio and leverage existing infrastructure [21] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the uncertainty regarding the impact of COVID-19 on sales and revenue, but noted a positive trend in face-to-face interactions with healthcare providers [59] - The company anticipates Q3 2022 NERLYNX net sales in the range of $44 million to $47 million, with a net loss expected between $1 million and $2 million [50][52] Other Important Information - The company plans to submit final data from the SUMMIT trial to the FDA later this year [17] - Cash burn for Q2 2022 was approximately $14 million, down from $17 million in Q1 2022 [54] Q&A Session Summary Question: Changes in sales force structure due to increased live interactions - Management believes that a combination of live and virtual interactions will be the new normal, and they are currently satisfied with the size of the sales force [63][65] Question: Presentation of updated HER2-mutated breast cancer data - Management anticipates presenting updated data at the San Antonio Breast Cancer meeting, but the timing of FDA disclosures is uncertain [68] Question: Long-term profitability and cost management - Management reiterated the commitment to being net income positive and cash flow positive, with potential further cost cuts if necessary [77]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-35703 PUMA BIOTECHNOLOGY, INC. (Exact name of registrant as specified in its charter) Delaware 77-0683487 (State or other ...

Puma Biotechnology Earnings Call Commercial Update May 5, 2022 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 statem ...

Call Start: 16:30 January 1, 0000 5:10 PM ET Puma Biotechnology, Inc. (NASDAQ:PBYI) Q1 2022 Earnings Conference Call May 5, 2022 16:30 ET Company Participants Mariann Ohanesian - Senior Director of Investor Relations Alan Auerbach - Chairman, President & Chief Executive Officer Jeffrey Ludwig - Chief Commercial Officer Maximo Nougues - Chief Financial Officer Conference Call Participants Ed White - H.C. Wainwright Alex Hammond - Bank of America Operator Good afternoon. My name is Karen, and I will be your c ...