PBYI

Image source: The Motley Fool. Thursday, Aug. 6, 2026 at 4:30 p.m. ET Chief Executive Officer President and Chairman of the Board-Alan H. Auerbach Chief Financial Officer-Maximo F. Nougues Senior Vice President of Marketing-Heather Blaber Senior Vice President of Sales-Roger L. Storms Senior Director of IR-Mariann Ohanesian Operator: Good afternoon. My name is Daryl, and I will be your conference call operator today. At this time, all participants are in a listen-only mode. After the speakers' formal remarks, there will be a question-and-answer session. If you would like to ask a question during that time, simply press As a reminder, this call is being recorded. I would now like to turn the conference call over to Mariann Ohanesian, Senior Director of IR for Puma Biotechnology You may begin your conference. Mariann Ohanesian: Thank you, Daryl. Good afternoon and welcome to Puma's conference call to discuss our earnings results for the second quarter of 2026. Joining me on the call today are Alan H. Auerbach, Chief Executive Officer President and Chairman of the Board of Puma Biotechnology Maximo F. Nougues, Chief Financial Officer Heather Blaber, Senior Vice President of Marketing and Roger L. Storms, Senior Vice President of Sales. After the close of the market today, Puma issued a news release detailing earnings results for the second quarter of 2026. That news release, the slides that Roger will refer to and a webcast of this call are accessible via the homepage in Investor sections of our website at pumabottechnology.com. The webcast and presentation slides will be archived on our website and available for replay for the next 90 days. Today's conference call will include statements about Puma's future expectations, plans and prospects. that constitute forward-looking statements for purposes of federal securities laws. Such statements are subject to risks and uncertainties and actual events and results may differ from those expressed in these forward-looking statements. For a full discussion of these risks and uncertainties, please review our periodic and current reports filed with the SEC from time to time, including our annual report on Form 10-K for the year ended December 31, 2025. You are cautioned not to place undue reliance on these forward-looking statements. Which speak only as of the date of this live conference call. August 6, 2026. Puma undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call, except as required by law. During today's call, we may refer to certain non GAAP financial measures that involve adjustments to our GAAP figures. We believe these non GAAP metrics may be useful to investors as a supplement to, but not as a substitute for our GAAP financial measures. Please refer to our second quarter 26 earnings release for a reconciliation of our GAAP to non GAAP results. I will now turn the call over to Alan. Alan H. Auerbach: Thank you, Mariann, and thank you all for joining our call today. Today Puma reported total revenue for the second quarter of 26 of $56.5 million Total revenue includes product revenue net which consists entirely of NERLYNX sales as well as royalties from our sub licensees. Product revenue net was $53.6 million in the second quarter 26, an increase from $42 million reported in Q1 of 26 and $49.2 million reported in Q2 of 25. As a reminder to investors, Puma's reported NERLYNX sales includes both U. S. Net sales of NERLYNX and product supply revenues of NERLYNX to Puma's ex U. S. Partners. Product revenue for the second quarter of 26 included approximately $1.3 million of inventory drawdown at specialty pharmacies and specialty distributors. Royalty revenue was $2.9 million in the second quarter of 26, compared to $2.8 million in Q1 26 and $3.2 million in Q2 of 25. We reported 2.93 thousand bottles of NERLYNX sold in second quarter of 26, compared to 2.33 thousand bottles sold in Q1 of 26. We In Q2 26, we estimate that inventory decreased by 57 bottles. In Q2 26, new prescriptions were down approximately 6% compared to Q1 26, and total prescriptions were up approximately 7% compared to Q1 26. Roger will provide further details in his comments and slides. I will now provide updates from Puma's ongoing Phase II trials of alisertib small cell lung cancer and HER 2 negative ER-positive breast cancer. Also referred to as ELISCA lung 1 and ELISCA breast 1. Heather Blaber and Roger L. Storms will add additional color on NERLYNX commercial activities. Maximo F. Nougues will follow with highlights of the key components of our financial statements for the second quarter of 2026. As investors are aware, Puma has 2 ongoing Phase II trials of our investigational drug, Alicertib. ALISCA-Breast1, which is a phase 2 trial of alisertib in combination with endocrine therapy, in patients with HER2 negative, hormone receptor positive, recurrent, or metastatic breast cancer. ALISCA-Lung-1, a Phase 2 study looking at the efficacy of alisertib monotherapy in patients with small cell lung cancer. As a reminder, the ALISCA-Breast1 trial investigates alisertib in combination with endocrine treatment consisting of either anastrozole, exemestane, letrozole, fulvestrant, or tamoxifen, in patients with HER2 negative hormone receptor positive recurrent or metastatic breast cancer. Patients must be chemotherapy naive in the recurrent or metastatic setting Have had previous treatment with a CDK4/6 inhibitor, and have received at least 2 prior lines of endocrine therapy in the recurrent or metastatic setting to be eligible for the trial. Patients were initially being dosed with alisertib given at either 30 milligrams, 40 milligrams, or 50 milligrams twice daily bid on days 1 to 3, 8 to 10, and 15 to 17. On a 28 day cycle in combination with endocrine therapy of the investigator's choice. Patients must not have been previously treated with the endocrine treatment in the metastatic setting that will be given in combination with alisertib in the trial. Interim data from this trial was presented on the company's first quarter conference call. As discussed during that presentation, the company believes that the data obtained to date from ALISCA-Breast1 is providing a preliminary indication potentially better activity in patients with biomarkers where the aurora kinase pathway plays a role. Based on the feedback that we have received from breast cancer key opinion leaders on this interim data, the trial has been amended such that now we are only continuing enrollment in the 40 milligram and 50 milligram dose groups. That amendment to the protocol has been submitted to the FDA and the EU authorities and is being submitted to the IRBs as well. We are hoping to begin enrollment under that amended protocol in Q3. We will also be updating interim data from the ALISCA-Breast1 trial, including longer term patient follow-up, in the fourth quarter of this year. With respect to the ALISCA-Lung1 study, as investors are aware Puma has an ongoing Phase 2 trial of our investigational drug alisertib to investigate the efficacy of alisertib monotherapy In patients with small cell lung cancer. Interim data from this trial was presented on the company's first quarter earnings call. As discussed during the presentation, the company believes that the data obtained to date from ALISCA-Lung1 is providing a preliminary indication of potentially better activity in patients with the biomarkers where the aurora kinase pathway is playing a role. As was also discussed on that call, the company previously amended the trial to increase the dose from 50 milligrams BID to 60 milligrams BID. Dosing of the trial was further increased to 70 milligrams BID and the company is currently enrolling patients at the 70 milligram BID level. There are currently 92 patients in the trial, with 36 of the patients enrolled at the 60 milligram BID dose and 4 patients enrolled at the 70 milligram dose. As was also mentioned on the recent earnings call, Puma also plans to initiate a second trial of alisertib in small cell lung cancer, ALISCA-Lung-2, where the drug will be given in combination with paclitaxel similar to the phase 2 randomized trial that was previously published in the Journal of Thoracic Oncology. The company anticipates that enrollment in the ALISCA-Lung2 trial will start in Q3. The company will provide investors with further information on this trial in the future. The company anticipates that it will have additional interim data from ELISCA-Lung-1 and the initial data from ELISCA-Lung-2 in 2027. As mentioned on prior earnings calls and in response to investor questions, Puma continues to evaluate several commercial stage and development stage drugs to potentially in license or acquire that would allow the company to diversify itself and leverage Puma's existing R&D, regulatory and commercial infrastructure. The company will keep investors updated on this as it progresses. I will now turn the call over to Heather Blaber for an update on our marketing initiatives. Roger L. Storms will follow with a review of our commercial performance during the quarter. Heather Blaber: Thanks, Alan. I appreciate the opportunity to share some additional insights into our marketing strategy. The marketing team is focused on continued awareness of both clinical data for NERLYNX as well as reinforcing the continued unmet need in HER2-positive early stage breast cancer after adjuvant therapy. We continue to invest in market research to help us understand and validate the most effective ways to communicate our data with healthcare professionals through both personal and non personal promotion. Our strategy is focused on increasing awareness of our dual indication in HER2 positive breast cancer, we believe NERLYNX plays an important role in the early stage by reducing the risk of recurrence and in the metastatic setting by helping protect against progression. Not only do physicians who have experience with NERLYNX continue to identify appropriate patients that could benefit from additional therapy post adjuvant treatment but we continue to adopt new prescribers year over year who recognize the unmet need in HER2-positive early stage breast cancer and how NERLYNX may help their patients reduce their risk of recurrence. In summary, we are excited and committed to engage with more oncologists, and support their patients diagnosed with HER2 positive breast cancer in both the early and metastatic setting. I will now turn the call over to Roger L. Storms to provide an overview on the commercial performance for the second quarter. Roger L. Storms: Thank you, Heather, and thanks to everyone for joining our second quarter earnings call. Before I move into the commercial review, just a reminder that I will be making forward looking statements. The sales team remains focused on increasing the use of NERLYNX with the main focus on patients at higher risk of recurrence. They are also dedicated to enhancing clinical education, and engagement through non personal promotional efforts as well as utilizing patient resources to support persistence and compliance during NERLYNX therapy. Let me now transition to some of the commercial slides where I will provide some additional specifics around performance. Slide 3 is an illustration of our distribution model. Which is broken out into the specialty pharmacy channel and the specialty distributor or in office dispensing channel. Regarding the overall distribution of our business, in Q2 26, about 61% of our business was purchased through the SP channel and the remaining 39% was purchased through the SD channel. We continue to see stronger growth in the SD channel driven by 2 main factors. Increased sales in the group purchasing organizations, GPO segment and increasing 340B purchasing. Turning to Slide 4, NERLYNX net product revenue in Q2 26 was 53.6 million an increase from the $42 million reported in Q1 26 and the $49.2 million we reported in Q2 of 25. As a reminder to investors, Puma's reported NERLYNX sales include both U. S. Net sales of NERLYNX and product supply revenues of NERLYNX to Puma's ex U. S. Partners. Please note that in Q2 26, we reported minimal product supply revenue to our international partners versus about $100 thousand in Q1 of 26. I will provide some more details around inventory changes and Maximo will provide some additional specifics around gross to net expenses during his update. In Q2 26, we estimate that inventory decreased by about 1 million As a comparator, we estimate that inventory decreased by about $7.9 million in Q1 of 26. Slide 5 shows Q2 26 ex factory bottle sales and also provides both a year over year and a quarter over quarter comparison. As a reminder, ex factory bottles include sales to our S and SD channels. In Q2 26, NERLYNX ex factory bottle sales were 2.93 thousand. Which represents an approximate 26% increase quarter over quarter 12% increase year over year. Let me specifically call out the inventory changes from a bottle perspective. In Q2 26, we estimate that inventory decreased by 57 bottles. As a comparator, we estimate that inventory decreased by 39 bottles in Q1 of 26 and decreased by 85 bottles in Q2 of 25. Slide 6 highlights our commercial demand for the quarter. In Q2 26, U. S. Demand was 2.99 thousand bottles, which represents an approximate 8% increase quarter over quarter and 11% increase year over year. As mentioned earlier, we have seen stronger growth in the SD channel, where we saw demand grow by about 12% quarter-over-quarter and 32% year-over-year. The year over year and quarter over quarter increases are a direct result of continued emphasis put on executional excellence and increased field accountability. Our Q2 26 call activity increased 18% year-over-year, 2% quarter-over-quarter, and total prescriptions or TRx increased by 7% quarter-over-quarter and 3% year-over-year. Enrollments in the quarter grew 1% quarter-over-quarter and 12% year-over-year. Commercial new patient starts in the quarter declined 6% quarter-over-quarter and grew 8% year-over-year. Continued messaging and adoption of dose escalation remains an important commercial priority. And 73% of patients started NERLYNX at a reduced dose. We believe dose escalation coupled with patient education resources will give patients better support throughout their NERLYNX therapy and ultimately help them reduce the risk of recurrence. Slide 7 highlights the strategic collaborations we formed across the globe. Most recently, in Q1 26, NERLYNX was launched in Thailand, also in the extended adjuvant setting. We really appreciate the excellent work being done by our partners around the world and look forward to supporting their continued success moving forward. I will close by sharing my sincere appreciation for the entire Puma team their steadfast commitment to supporting patients and families affected by breast cancer This disease is truly devastating. While meaningful progress has been made, we know there is still important work ahead and even more we can accomplish together. I will now turn the call over to Maximo for a review of our financial results. Maximo F. Nougues: Thanks, Roger. I will begin with a brief summary of our financial results for the second quarter of 2026. Please note I will make comparisons to Q1 26 which we believe is a better indication of our progress as a commercial company and year over year comparisons. For more information, I recommend that you refer to our second quarter 30 Q. Which will be filed today includes our consolidated financial statements. For the second quarter of 26, we reported net income based on GAAP of 8.2 million or $0.16 per diluted share. This compares to a net loss in Q1 26 of 3.8 million or $0.07 per share. On a non GAAP basis, which is adjusted to remove the impact of stock based compensation expense, we reported net income of $10.1 million or $0.20 per basic share and $0.19 per diluted share. For the second quarter of 2026. Gross revenue from NERLYNX sales was $74.3 million in Q2 26 and $57.5 million in Q1 20 As Alan mentioned, product revenue from NERLYNX sales was $53.6 million an increase from the $42 million reported in Q1 26 and the $49.2 million reported in Q2 25. As a reminder to investors, Puma's reported NERLYNX sales include both US net sales of NERLYNX and product supply revenue of NERLYNX to Puma's ex-U.S. partners. Please note that in Q2 26, we reported product supply revenue to our international partners of around 23 thousand. Therefore, U. S. Net sales of NERLYNX in Q2 26 were $53.6 million versus $41.9 million in Q1 26. The increase in net product revenue in Q2 26 versus Q1 26 was driven by higher demand, inventory decrease in Q2 of about 1.3 million versus inventory decrease of $7.9 million in Q1 2026, offset by a higher gross to net in Q2. Royalty revenue totaled $2.9 million in the second quarter of 26 compared to $2.9 million in Q1 26. Our gross to net adjustment in Q2 26 was about 27.9% and 27 percent in Q1 26. The high gross to net adjustment was driven by higher Medicaid share. Cost of sales for Q2 26 was $12.5 million and includes $2.4 million for the amortization of intangible assets related to our neratinib license. Cost of sales from Q1 26 was 10.4 million Going forward, we will continue to recognize amortization of milestones to the licensor of about $2.4 million per quarter as cost of sales. For fiscal year 26, Puma anticipates that net NERLYNX product revenue will be in the range of $205 million to $209 million higher than our prior guidance of $202 million to $206 million We also anticipate that our gross to net adjustment for the full year 2026 will be between 26.5% and 27.5%. In addition, for fiscal year 26, we anticipate receiving royalties from our partners around the world in the range of $19 million to $22 million slightly lower than our prior guidance of $20 million to $23 million Under our sublicense agreement covering China, the royalty rate payable to us is subject to reduction when the market share of generic versions of NERLYNX in China reaches a specific threshold. We are unable to predict with certainty when this threshold will be reached. However, we believe it is possible that the threshold could be reached triggering the royalty rate reduction in late 2026 or in 2027. We do not expect any license revenue in 2026. We also expect that net income for the full year will be in the range of $17 million to $20 million also higher than our prior guidance of $16 million to $19 million The current guidance does not include any potential release of any additional tax asset valuation allowance in our net income estimate. The company is reviewing its deferred tax assets as part of its ongoing tax valuation analysis and has not yet determined whether any adjustment will be required or if so, the potential timing or size of such an adjustment. We will continue to keep investors updated on this as it progresses. At this time, we do not believe that the tariffs imposed or proposed to be imposed by the United States, particularly with other countries, will have a material impact on our product cost or results of operations. However, shift in trade policies in the United States and other countries have been rapidly evolving and are difficult to predict. As a point of reference, our manufacturing product cost accounts for a mid to high single digit percentage of our total cost of goods sold. We anticipate that for Q3 26, NERLYNX product revenue net will be in the range of $54 million to $56 million We expect Q3 royalty revenues will be in the share in the range of $2 million to $3 million and no license revenue. Further estimate that the gross to net adjustment in Q3 26 will be approximately 26% to 27%. Puma anticipates a Q3 net income between $2 million and $2.5 million SG&A expenses were $17.5 million in the second quarter of 26 compared to $18.4 million in the first quarter of 26. SG&A expenses include non cash charges for stock based compensation of $1.2 million for Q2 26 and $1.1 million for Q1 26. Research and development expenses were $18.9 million in the second quarter of 2026 and $19.8 million in Q1 26. R&D expenses included non cash charges for stock based compensation of $800 thousand in Q2 2026 and $800 thousand in Q1 26. And then the expense side, Puma anticipates higher total operating expenses in 2020 compared to 2025. More specifically, we anticipate SG&A expenses increase by 1% to 2% and R&D expenses to increase by 34% to 37% year over year. The higher increase in R&D is driven by the progress of our clinical trials. In the second quarter of 26, Puma reported cash burn of approximately 9.7 million This compares to cash burn of approximately $4 million in Q1 2026. Please note that during Q2 26, we made our final quarterly principal loan payment of 11.1 million related to our obligation with Athyrium. As a result, Puma now is debt-free. At June 30, 2026, we had approximately $93.9 million cash, cash equivalents, and marketable securities, Versus 97.5 million at year end 2025. Our accounts receivable balance was $34.1 million Our accounts receivable terms range between 10 and 68 days. While our daily sales outstanding is above 44 days. We estimate that as of June 30, 2026, our distribution network maintained approximately 3 weeks of inventory. Overall, we continue to deploy our financial resources to focus on the commercialization of NERLYNX, the development of alisertib, and controlling our expense. Alan H. Auerbach: Thanks, Maximo. On past earnings calls, I have stressed that Puma senior management in cooperation with the Board of Directors continues to remain focused on NERLYNX sales trends and recognizes its fiscal responsibility to shareholders to continue to maintain positive net income. We believe that this focus has contributed to our commercial execution thus far in 2026. According to our current projections, 2026 will mark the second year over year demand increase for NERLYNX in The United States. And the first time in the history of the launch of NERLYNX in The United States, that we have seen 2 positive consecutive year over year increases in demand. We are pleased to report this demand driven increase in NERLYNX sales in the second quarter of 2026, and we believe that the positive net income that the company is guiding to for full year 2026 has resulted from both this increased demand as well as the continued financial discipline across the company over the last few years. The company remains committed to continuing to achieve this positive net income and will continue to reduce expenses if needed to achieve this. We look forward to updating investors on this in the future. There continues to remain a significant unmet need for patients battling breast cancer, lung cancer, and other solid tumors. We at Puma are committed and passionate about finding more effective ways of helping these patients during their journey, and we will continue to strive to achieve that goal. This concludes today's presentation. We will now turn the floor back to the operator for Q&A. Operator? Operator: Thank you. We will now begin the question-and-answer session. If you wish to withdraw your request, please press 2. For participants using speaker equipment, it may be necessary to pick up your handset Our first question comes from the line of Marc Frahm with TD Cowen. Please proceed with your questions. Mark Frahm: Hey, thanks and congrats on the strong quarter and kind of recent commercial performance. But maybe looking a little further beyond the formal guidance, you have a couple of trials ongoing and another 1 to kind of start up. Can you maybe speak to Alan, what the kind of R&D spend trajectory looks like maybe beyond just kind of Q3 and more into as we look into 2027 as some of those trials are a little more fully up and running. Alan H. Auerbach: So in terms of the R&D in 2027., 2028, 2029, we have gotten this question from investors before which is let's say you want to do the Phase III trials of both alisertib in ER positive breast cancer and in small cell lung cancer, can you do that? And the answer to that is-- you know, according to our current projections, yes. We probably have to stagger them. So like start 1 before the other type of thing. It is completely achievable and that is what we are looking to do. You know, we think that with the, you know, thankfully now we are a debt free company. So we are cash flow positive. Obviously, thinking investing that in alisertib is a good thing with the shareholders. So very, very interesting drug. We are very pleased with the data. And assuming the data continues to hold up, we are very eager to start the Phase 3 trials. And I think that we have the ability to do that you know, hopefully, knock on wood next year. And I think that is where we are heading. So I think there is no reason we cannot run both of them. Like I said, we are committed to maintaining, you know, positive net income. If we have to stagger the trials, then we can stagger. Okay, that is helpful. Mark Frahm: And then also in your prepared remarks, you mentioned continuing to evaluate BD opportunities. Can you speak a little bit more as to kind of what would be of interest? I mean, should we look at alisertib as very much the model in terms of stage? Or would you be willing to take on maybe either a little bit more of an upfront or you are maybe a little bit earlier stage projects. Alan H. Auerbach: Yes, so from a BD perspective we look at commercial assets and we look at development stage ones. On the commercial side, I think that we have shown strong ability to you know, obviously, you know, cut costs, you know, generate cash from our commercial assets. And if there is ones out there where we feel like we could fit it into the existing organization, and continue to do that for shareholders add on additional sales, build additional cash, I think that would be something very wise to do for the shareholders. On the development stage side, obviously there is a lot of drugs being developed right now in the oncology space. You know, if there is something where we feel that it is a unique asset and something where we, you know, believe that, you know, we can contribute to shareholder value by bringing it in and developing it clinically. You know, we are happy to look at that. We are we are not technology-agnostic if you will, like we just only look at small molecules or something like that. We are happy to look at, you know, anything any other technologies. And I guess same thing would be true on the commercial side as well. Is it just something in breast or lung cancer? Again, happy to look at things that are outside of that if we feel that we can, number 1, most importantly help cancer patients, and number 2, by helping cancer patients benefit the shareholders. Okay, that is helpful. Thank you. Operator: Thank you. This concludes our question-and-answer session. I would now like to turn the conference back to Mariann for closing remarks. Mariann Ohanesian: Thank you all for joining us today. As a reminder, this call may be accessed via replay of the webcast at pumabiotechnology.com beginning later today. Have a good evening. Operator: Ladies and gentlemen, thank you for participating in today's conference call. This concludes our program. Everyone, have a great day. You may now disconnect. Before you buy stock in Puma Biotechnology, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Puma Biotechnology wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $421,943!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,382,819!* Now, it’s worth noting Stock Advisor’s total average return is 983% — a market-crushing outperformance compared to 216% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of August 14, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Puma Biotechnology (PBYI) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management attributes the 26% quarter-over-quarter increase in NERLYNX bottle sales to a combination of higher demand and a significant reduction in inventory drawdown compared to the previous quarter. The company has achieved a debt-free balance sheet following the final principal payment of 11.1 million to Athyrium, providing greater flexibility for R&D investment. Strategic focus has shifted toward biomarker-driven patient selection for alisertib, with trial amendments now prioritizing higher dose levels (40mg-50mg) where preliminary activity is strongest. Commercial growth is being driven by the Specialty Distributor channel, specifically through increased engagement with Group Purchasing Organizations and 340B purchasing programs. Management emphasizes a 'fiscal responsibility' framework, maintaining positive net income by balancing commercial execution with disciplined expense management. The company is actively pursuing business development to diversify its portfolio, leveraging existing infrastructure to evaluate both commercial-stage and development-stage oncology assets. Full-year 2026 NERLYNX product revenue guidance was raised to a range of $205 million to $209 million, reflecting sustained demand trends. R&D expenses are projected to increase by 34% to 37% year-over-year as clinical trials for alisertib in lung and breast cancer progress into higher-dose cohorts. Management anticipates a potential royalty rate reduction for NERLYNX in China in late 2026 or 2027 if generic market share reaches a specific, undisclosed threshold. The company plans to initiate the ALISCA-Lung2 trial in Q3 2026, which will evaluate alisertib in combination with paclitaxel. Future Phase 3 trial starts for alisertib may be staggered to ensure the company maintains its commitment to positive net income and cash flow sustainability. Gross-to-net adjustments for Q2 were elevated at 27.9%, primarily driven by a higher share of Medicaid patients in the payer mix. The company is currently reviewing its deferred tax assets, which may lead to a future release of tax asset valuation allowances, though timing and size remain undetermined. Inventory levels in the distribution network are being maintained at approximately three weeks of supply as of June 30, 2026. While manufacturing costs are only a mid-to-high single-digit percentage of COGS, management is monitoring evolving U.S. trade policies and potential tariffs for future impacts. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management confirmed they have the financial capacity to run Phase 3 trials for both breast and lung cancer indications by potentially staggering their start dates. The transition to a debt-free, cash-flow-positive status is cited as the primary enabler for these long-term R&D investments. Puma is looking for commercial assets that can be integrated into their existing organization to build cash, as well as unique development-stage oncology assets. The company is not technology-agnostic and is open to evaluating various technologies and therapeutic areas outside of breast and lung cancer to benefit patients and shareholders. and willing to look beyond small molecules or their current focus on breast and lung cancer if the asset adds shareholder value.

Interested in Puma Biotechnology, Inc.? Here are five stocks we like better. Q2 performance improved: Puma Biotechnology reported $56.5 million in revenue and GAAP net income of $8.2 million, compared with a $3.8 million loss in Q1. NERLYNX product revenue rose to $53.6 million as U.S. demand increased. 2026 guidance was raised: The company increased its full-year NERLYNX revenue outlook to $205 million–$209 million and net-income forecast to $17 million–$20 million, while lowering its royalty revenue forecast because of potential generic competition in China. Pipeline and balance sheet advanced: Puma plans to continue Phase II studies of alisertib in breast and small-cell lung cancer, with additional data expected later this year and in 2027. The company ended the quarter with $93.9 million in cash and became debt-free after making its final $11.1 million obligation payment. 3 small-cap biotechs with potential breakthroughs in 2024 Puma Biotechnology (NASDAQ:PBYI) reported second-quarter 2026 total revenue of $56.5 million, including $53.6 million in net product revenue from NERLYNX and $2.9 million in royalty revenue. The company posted GAAP net income of $8.2 million, or $0.16 per diluted share, compared with a net loss of $3.8 million, or $0.07 per share, in the first quarter. Chief Executive Officer Alan Auerbach said net NERLYNX product revenue increased from $42 million in the prior quarter and $49.2 million in the second quarter of 2025. Reported NERLYNX revenue includes U.S. net sales and product supply revenue to ex-U.S. partners. International product supply revenue was approximately $23,000 during the quarter, meaning nearly all of the reported product revenue came from U.S. sales. → Meta’s Earnings Drop Shows Wall Street Wants More Than Ad Growth Puma sold 2,929 NERLYNX bottles in the second quarter, up from 2,328 bottles in the first quarter. The company estimated that inventory declined by 57 bottles during the quarter, compared with a decline of 439 bottles in the first quarter. Senior Vice President of Sales Roger Storms said U.S. demand reached 2,986 bottles, representing an 8% sequential increase and an 11% year-over-year increase. Ex-factory bottle sales increased approximately 26% from the first quarter and 12% from a year earlier. → 4 Oil and Gas ETF Plays as Prices Stay Sky-High The specialty pharmacy channel accounted for about 61% of the company’s business in the second quarter, while specialty distributors and in-office dispensing represented the remaining 39%. Storms said growth was stronger in the specialty distributor channel, supported by increased group purchasing organization activity and greater 340B purchasing. Total prescriptions increased 7% sequentially and 3% year over year. New prescriptions declined about 6% from the first quarter. Commercial new-patient starts fell 6% sequentially but rose 8% from a year earlier. Patient enrollments increased 1% sequentially and 12% year over year. About 73% of patients began NERLYNX at a reduced dose, reflecting the company’s focus on dose escalation and patient support. Senior Vice President of Marketing Heather Blaber said Puma remains focused on expanding awareness of NERLYNX’s dual indication in HER2-positive breast cancer, including its role in reducing recurrence risk in early-stage disease and helping protect against progression in the metastatic setting. The company also launched NERLYNX in Thailand during the first quarter for the extended adjuvant setting. → Ulta's Growth Is Real, But So Are the Risks Puma is advancing two ongoing Phase II trials of investigational drug alisertib: ALISCA-Breast1 in HER2-negative hormone receptor-positive recurrent or metastatic breast cancer, and ALISCA-Lung1 in small cell lung cancer. Auerbach said interim data from ALISCA-Breast1 have provided what the company views as a preliminary indication of potentially better activity among patients with biomarkers associated with the Aurora kinase pathway. Following feedback from breast-cancer key opinion leaders, Puma amended the study to continue enrollment only in the 40 mg and 50 mg twice-daily dose groups. The amendment has been submitted to the FDA and European authorities and is being submitted to institutional review boards. Puma expects enrollment under the amended protocol to begin in the third quarter and plans to provide updated interim data, including longer-term follow-up, in the fourth quarter. In ALISCA-Lung1, Puma is evaluating alisertib monotherapy in small cell lung cancer. The study has enrolled 92 patients, including 36 patients at the 60 mg twice-daily dose and four patients at the 70 mg dose. The company is currently enrolling at 70 mg twice daily. Puma also expects to begin enrolling patients in ALISCA-Lung2 during the third quarter. That study will evaluate alisertib in combination with paclitaxel in small cell lung cancer. The company expects additional interim data from ALISCA-Lung1 and initial data from ALISCA-Lung2 in 2027. During the question-and-answer session, Auerbach said Puma believes it could fund potential Phase III studies in both ER-positive breast cancer and small cell lung cancer based on its current projections, though it may stagger the trials to maintain positive net income. He also said the company continues to evaluate commercial-stage and development-stage business-development opportunities, including assets beyond breast and lung cancer. Chief Financial Officer Maximo Nougues said Puma raised its full-year net NERLYNX product revenue outlook to $205 million to $209 million, from prior guidance of $202 million to $206 million. The company raised its full-year net-income outlook to $17 million to $20 million, compared with prior guidance of $16 million to $19 million. Puma lowered its expected 2026 royalty revenue range to $19 million to $22 million from $20 million to $23 million. Nougues said royalty rates under the company’s China sublicense agreement could decline if generic NERLYNX market share reaches a specified threshold, which Puma believes could occur in late 2026 or 2027. For the third quarter, Puma expects net NERLYNX product revenue of $54 million to $56 million, royalty revenue of $2 million to $3 million, and net income of $2 million to $2.5 million. The company expects third-quarter gross-to-net adjustments of approximately 26% to 27%. Second-quarter SG&A expenses were $17.5 million, down from $18.4 million in the first quarter, while research and development expenses were $18.9 million, down from $19.8 million. Puma expects 2026 SG&A expense to increase 1% to 2% year over year and R&D expense to increase 34% to 37%, driven by progress in its clinical trials. Puma ended the quarter with approximately $93.9 million in cash equivalents and marketable securities. The company made its final $11.1 million quarterly principal payment on its Athyrium obligation during the quarter and is now debt-free, Nougues said. Puma Biotechnology, Inc is a late‐stage biopharmaceutical company dedicated to the development and commercialization of targeted therapies for oncology patients. Founded in 2010 and headquartered in Los Angeles, California, the company focuses on advancing molecularly defined cancer treatments that address significant unmet medical needs. The company's lead product is neratinib, marketed under the brand name Nerlynx in the United States. Neratinib is an irreversible small‐molecule tyrosine kinase inhibitor designed to target the HER2 receptor, and it received FDA approval in 2017 for extended adjuvant treatment of early‐stage HER2-positive breast cancer. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Puma Biotechnology Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

This article first appeared on GuruFocus. Total Revenue: $56.5 million in Q2 2026. Product Revenue, Net: $53.6 million, up from $42 million in Q1 2026 and $49.2 million in Q2 2025. Royalty Revenue: $2.9 million in Q2 2026, compared to $2.8 million in Q1 2026 and $3.2 million in Q2 2025. Net Income (GAAP): $8.2 million, or $0.16 per diluted share, versus a net loss of $3.8 million in Q1 2026. Net Income (Non-GAAP): $10.1 million, or $0.20 per basic share and $0.19 per diluted share. Gross Revenue from NERLYNX Sales: $74.3 million in Q2 2026, up from $57.5 million in Q1 2026. Gross to Net Adjustment: 27.9% in Q2 2026, compared to 27% in Q1 2026. Cost of Sales: $12.5 million in Q2 2026, including $2.4 million for amortization of intangible assets. SG&A Expenses: $17.5 million in Q2 2026, down from $18.4 million in Q1 2026. R&D Expenses: $18.9 million in Q2 2026, down from $19.8 million in Q1 2026. Cash Burn: Approximately $9.7 million in Q2 2026, compared to cash generated of approximately $4 million in Q1. Cash Position: $93.9 million in cash, cash equivalents, and marketable securities as of June 30, 2026. NERLYNX Bottles Sold (Ex-Factory): 2,929 bottles in Q2 2026, a 26% increase quarter over quarter and 12% increase year over year. U.S. Demand: 2,986 bottles in Q2 2026, an 8% increase quarter over quarter and 11% increase year over year. Total Prescriptions (TRx): Increased 7% quarter over quarter and 3% year over year. New Prescriptions: Down approximately 6% compared to Q1 2026. FY 2026 Net Product Revenue Guidance: Raised to $205 million to $209 million. FY 2026 Royalty Guidance: $19 million to $22 million. FY 2026 Net Income Guidance: Raised to $17 million to $20 million. Warning! GuruFocus has detected 9 Warning Signs with PBYI. Is PBYI fairly valued? Test your thesis with our free DCF calculator. Release Date: August 06, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Puma Biotechnology Inc (NASDAQ:PBYI) reported a strong second quarter with net product revenue of $53.6 million, a 27.6% increase from Q1 2026 and a 9% increase year-over-year. The company achieved GAAP net income of $8.2 million in Q2 2026, a significant improvement from the net loss of $3.8 million in Q1 2026. Puma Biotechnology Inc (NASDAQ:PBYI) is now debt-free after making its final loan payment of $11.1 million, strengthening its financial position. The company raised its full-year 2026 net product revenue guidance to $205-$209 million and net income guidance to $17-$20 million, reflecting confidence in continued growth. U.S. demand for NERLYNX increased 8% quarter-over-quarter and 11% year-over-year, with total prescriptions up 7% quarter-over-quarter, indicating strong commercial execution. Puma Biotechnology Inc (NASDAQ:PBYI) is advancing its alisertib clinical program, with plans to initiate ALISCA-Lung2 in Q3 2026 and potential for Phase III trials in 2027. New prescriptions for NERLYNX declined 6% quarter-over-quarter in Q2 2026, suggesting a potential slowdown in patient starts. The gross-to-net adjustment increased to 27.9% in Q2 2026 from 27% in Q1 2026, driven by a higher Medicaid share of sales, which could pressure future margins. Royalty revenue guidance for 2026 was lowered to $19-$22 million from the prior range of $20-$23 million, partly due to potential generic competition in China. The company reported cash burn of approximately $9.7 million in Q2 2026, a reversal from the $4 million cash generated in Q1 2026. R&D expenses are expected to increase by 34%-37% year-over-year in 2026, which could strain profitability if clinical trials face delays or setbacks. Puma Biotechnology Inc (NASDAQ:PBYI) faces uncertainty regarding the potential reduction of royalty rates in China, which could occur in late 2026 or 2027. Q: Can you speak to the R&D spend trajectory as we look into 2027, given the ongoing trials and the planned start of ALISCA-Lung2?A: Alan Auerbach, CEO, stated that the company's current projections support the ability to fund Phase III trials for both alisertib in hormone receptor-positive breast cancer and small cell lung cancer. He noted that while the trials may need to be staggered, they are completely achievable. As a debt-free and cash flow positive company, Puma is eager to start Phase III trials next year, assuming the data continues to hold up, while remaining committed to maintaining positive net income. Q: Can you elaborate on the types of business development (BD) opportunities Puma is evaluating?A: Alan Auerbach, CEO, explained that Puma is looking at both commercial-stage and development-stage assets. On the commercial side, they seek assets that can fit into the existing organization to generate additional sales and cash. On the development side, they are open to unique oncology assets across various technologies, not limited to small molecules or specific cancer types, provided they can help patients and benefit shareholders. Q: What were the key drivers behind the strong commercial performance in Q2 2026?A: Roger Storms, SVP of Sales, highlighted that U.S. demand increased 8% quarter-over-quarter and 11% year-over-year, driven by executional excellence and increased field accountability. Call activity increased 18% year-over-year, and the specialty distributor channel saw demand grow by 32% year-over-year, fueled by growth in group purchasing organizations and 340B purchasing. Q: What is the current status of the ALISCA-Breast1 trial, and what are the next steps?A: Alan Auerbach, CEO, reported that based on feedback from key opinion leaders on interim data, the company is amending the protocol to continue enrollment only in the 40 mg and 50 mg dose groups. The amendment has been submitted to the FDA and EU authorities, with enrollment under the amended protocol expected to begin in Q3. Updated interim data, including longer-term follow-up, will be presented in Q4 2026. Q: What is the progress update on the ALISCA-Lung1 trial and the planned ALISCA-Lung2 trial?A: Alan Auerbach, CEO, noted that ALISCA-Lung1 currently has 92 patients enrolled, with dosing increased to 70 mg BID. The company plans to initiate ALISCA-Lung2, which will test alisertib in combination with paclitaxel, in Q3. Additional interim data from ALISCA-Lung1 and initial data from ALISCA-Lung2 are anticipated in 2027. Q: What is the company's financial guidance for the full year 2026?A: Maximo Nougues, CFO, raised guidance for net NERLYNX product revenue to $205 million to $209 million, up from prior guidance of $202 million to $206 million. Net income guidance was also raised to $17 million to $20 million, up from $16 million to $19 million. Royalty revenue guidance was slightly lowered to $19 million to $22 million, and the gross-to-net adjustment is expected to be between 26.5% and 27.5%. Q: Can you provide details on the company's cash position and debt status?A: Maximo Nougues, CFO, confirmed that Puma made its final quarterly principal loan payment of $11.1 million to Athyrium in Q2 2026, making the company debt-free. As of June 30, 2026, the company had approximately $93.9 million in cash, cash equivalents, and marketable securities. Q2 2026 cash burn was approximately $9.7 million. Q: What is the potential impact of tariffs on the company's operations?A: Maximo Nougues, CFO, stated that the company does not currently believe tariffs will have a material impact on product cost or results of operations. Manufacturing product cost accounts for a mid to high single-digit percentage of total cost of goods sold. However, he noted that shifting policies are rapidly evolving and difficult to predict. Q: What is the outlook for the China royalty rate reduction?A: Maximo Nougues, CFO, explained that under the sublicense agreement covering China, the royalty rate is subject to reduction when the market share of generic versions of NERLYNX reaches a specific threshold. While the company cannot predict the exact timing, it believes the threshold could be reached in late 2026 or 2027, potentially triggering a royalty rate reduction. Q: What are the expectations for Q3 2026?A: Maximo Nougues, CFO, guided for Q3 2026 net product revenue in the range of $54 million to $56 million, royalty revenue of $2 million to $3 million, and a gross-to-net adjustment of approximately 26% to 27%. No license revenue is expected in Q3. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Puma Biotechnology PBYI reported second-quarter 2026 adjusted earnings of 19 cents per share, beating the Zacks Consensus Estimate of 10 cents. In the year-ago quarter, the company had reported adjusted earnings of 15 cents per share. Total revenues for the quarter were $56.5 million, which beat the Zacks Consensus Estimate of $53 million. Revenues increased 7.8% year over year, driven by higher net product sales. Total revenues comprised net product sales of Nerlynx (neratinib), PBYI’s only marketed drug in the United States, and royalty revenues. Nerlynx is indicated for the treatment of early-stage HER2-positive breast cancer. Year to date, shares of Puma Biotechnology have rallied 36.5% compared with the industry’s 4.4% growth. Image Source: Zacks Investment Research Product revenues from Nerlynx totaled $53.6 million in the second quarter, up about 9% year over year. This metric beat our model estimate of $50.9 million. Royalty revenues declined 9.4% year over year to $2.9 million. Selling, general and administrative (SG&A) expenses (excluding stock-based compensation expense) declined 4.1% year over year to $16.3 million. Research and development (R&D) expenses (excluding stock-based compensation expense) totaled $18.2 million, up 22.1% year over year, reflecting higher costs associated with clinical studies on alisertib along with higher internal R&D expenses. As of June 30, 2026, PBYI had cash, cash equivalents, restricted cash and investment securities of $93.9 million compared with $101.5 million as of March 31, 2026. Puma Biotechnology raised its financial guidance for 2026. For full-year 2026, total revenues are expected to be in the range of $224-$231 million compared with the previous projection of $222-$229 million. The Zacks Consensus Estimate for the metric is pegged at $224.5 million. Net product revenues are projected to be in the range of $205-$209 million versus the earlier expectation of $202-$206 million. Meanwhile, royalty revenues are expected to be to range from $19 million to $22 million, down from the previous expectation of $20–$23 million. The company expects to generate net income of $17-$20 million compared with the earlier projection of $16-$19 million for 2026. For the third quarter of 2026, the company expects net product revenues to be between $54 million and $56 million and royalty revenues in the range of $2 million to $3 million. Total revenues are expected to be between $56 million and $59 million. The company anticipates reporting a net income of approximately $2 million to $3.5 million for the quarter. Puma Biotechnology in-licensed global development and commercialization rights to alisertib, an aurora kinase A inhibitor, from Japan’s Takeda in 2022. It is developing alisertib for hormone receptor-positive breast cancer as well as small-cell lung cancer (SCLC). The company is conducting a phase II ALISCA-Breast1 study on alisertib in combination with endocrine treatment in patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer. Updated data from the study are expected in the fourth quarter of 2026. PBYI is conducting ALISCA-Lung1, a phase II study evaluating alisertib as a monotherapy for the treatment of patients with extensive-stage SCLC. The company plans to expand enrollment in both these studies in the second half of 2026. Puma Biotechnology plans to initiate enrollment in the phase I/II ALISCA-Lung2 study of alisertib in combination with paclitaxel for the treatment of patients with extensive-stage SCLC in the third quarter of 2026. Puma Biotechnology, Inc. price-consensus-eps-surprise-chart | Puma Biotechnology, Inc. Quote Puma Biotechnology currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Harmony Biosciences HRMY and Liquidia Corporation LQDA, each currently sporting a Zacks Rank #1 (Strong Buy) and Altimmune ALT, which carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 60 days, earnings per share estimates for Harmony Biosciences have increased from $3.20 to $3.33 for 2026. Over the same period, estimates for earnings per share increased from $3.64 to $3.92 for 2027. HRMY shares have risen 3.5% year to date. Harmony Biosciences missed on earnings in three of the trailing four quarters and beat in the remaining one, delivering an average negative surprise of 13.97%. Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have increased to $3.02 from $2.97. Over the same period, EPS estimates for 2027 have risen to $5.31 from $4.81. LQDA shares have gained 159.3% year to date. Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%. Over the past 60 days, estimates for Altimmune’s 2026 loss per share have narrowed from 69 cents to 64 cents. Over the same period, loss estimates for 2027 have also improved from 73 cents to 64 cents. ALT shares have declined 16.7% year to date. Altimmune’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 15.81%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Puma Biotechnology, Inc. (PBYI) : Free Stock Analysis Report Altimmune, Inc. (ALT) : Free Stock Analysis Report Liquidia Corporation (LQDA) : Free Stock Analysis Report Harmony Biosciences Holdings, Inc. (HRMY) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Raising 2026 Revenue and Net Income Guidance Based on Increased Demand for NERLYNX LOS ANGELES, August 06, 2026--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced financial results for the second quarter ended June 30, 2026. Unless otherwise stated, all comparisons are for the second quarter 2026 compared to the second quarter 2025. Product revenue, net consists entirely of revenue from sales of NERLYNX®, Puma’s first commercial product. Product revenue, net in the second quarter of 2026 was $53.6 million, compared to product revenue, net of $49.2 million in the second quarter of 2025. Product revenue, net in the first six months of 2026 was $95.5 million, compared to $92.3 million in the first six months of 2025. Based on accounting principles generally accepted in the United States (GAAP), Puma reported net income of $8.2 million, or $0.16 per basic and diluted share, for the second quarter of 2026, compared to net income of $5.9 million, or $0.12 per basic and diluted share, for the second quarter of 2025. Net income for the first six months of 2026 was $4.4 million, or $0.09 per basic and diluted share, compared to net income of $8.8 million, or $0.18 per basic and diluted share, for the first six months of 2025. Non-GAAP adjusted net income was $10.1 million, or $0.20 per basic share and $0.19 per diluted share, for the second quarter of 2026, compared to non-GAAP adjusted net income of $7.5 million, or $0.15 per basic and diluted share, for the second quarter of 2025. Non-GAAP adjusted net income for the first six months of 2026 was $8.3 million, or $0.16 per basic and diluted share, compared to non-GAAP adjusted net income of $12.4 million, or $0.25 per basic and diluted share, for the first six months of 2025. Non-GAAP adjusted net income excludes stock-based compensation expense. For a reconciliation of GAAP net income to non-GAAP adjusted net income and GAAP net income per share to non-GAAP adjusted net income per share, please see the financial tables at the end of this news release. Net cash provided by operating activities for the second quarter of 2026 was $1.6 million, compared to $14.1 million in the second quarter of 2025. Net cash provided by operating activities for the first six months of 2026 was $17.0 million, compared to net cash provided by operating activities of $17.7 million in the first six months of 2025. As previously reported, on May 4, 2026, Puma remitted the final payment of principal, interest and exit fees under its 2021 Note Purchase Agreement, which reduced outstanding debt to zero and terminated all remaining obligations, other than customary continuing indemnification obligations. At June 30, 2026, Puma had cash, cash equivalents and marketable securities of $93.9 million, compared to cash, cash equivalents and marketable securities of $97.5 million at December 31, 2025. "We are pleased with our commercial execution in the second quarter and the continued increase in year-over-year demand for NERLYNX. We are also pleased with our continued progress across our clinical development programs during the second quarter," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. "We remain focused on both continuing our commercial execution in the second half of the year as well as with continuing to advance alisertib in the respective ALISCA® clinical trials in HER2-negative, hormone receptor-positive metastatic breast cancer and small cell lung cancer." Mr. Auerbach added, "We anticipate the following key milestones over the next 12 months: (i) initiation of enrollment in ALISCA®-Lung2, a Phase I/II trial of alisertib in combination with paclitaxel for the treatment of patients with extensive stage small cell lung cancer (Q3 2026); (ii) expansion of enrollment in ALISCA®-Breast1, a Phase II trial of alisertib in combination with endocrine treatment in patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer (H2 2026); (iii) expansion of ALISCA®-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer (H2 2026); and (iv) presentation of updated data from ALISCA®-Breast1, a Phase II trial of alisertib in combination with endocrine treatment in patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer (Q4 2026)." Revenue Total revenue consists of product revenue, net from sales of NERLYNX, Puma’s first commercial product, and royalty revenue. For the second quarter ended June 30, 2026, total revenue was $56.5 million, of which $53.6 million was net product revenue and $2.9 million was royalty revenue. This compares to total revenue for the second quarter of 2025 of $52.4 million, of which $49.2 million was net product revenue and $3.2 million was royalty revenue. For the first six months of 2026, total revenue was $101.3 million, of which $95.5 million was net product revenue and $5.8 million was royalty revenue. This compares to total revenue for the first six months of 2025 of $98.4 million, of which $92.3 million was net product revenue and $6.1 million was royalty revenue. Operating Costs and Expenses Total operating costs and expenses were $48.9 million for the second quarter of 2026, compared to $45.8 million for the second quarter of 2025. Operating costs and expenses in the first six months of 2026 were $97.5 million, compared to $87.8 million in the first six months of 2025, primarily attributable to an increase in research and development (R&D) expenses, including an increase in clinical trial expense of approximately $7.4 million and an increase in internal R&D expense of approximately $2.0 million. Cost of Sales Cost of sales was $12.5 million for the second quarter of 2026, compared to $12.3 million for the second quarter of 2025. Cost of sales was $22.9 million for the first six months of 2026, virtually unchanged from the first six months of 2025, while year-over-year sales of our product bottles were higher. Selling, General and Administrative Expenses Selling, general and administrative (SG&A) expenses were $17.5 million for the second quarter of 2026, compared to $18.0 million for the second quarter of 2025. SG&A expenses for the first six months of 2026 were $35.9 million, compared to $35.6 million for the first six months of 2025. Research and Development Expenses Research and development (R&D) expenses were $18.9 million for the second quarter of 2026, compared to $15.5 million for the second quarter of 2025. R&D expenses for the first six months of 2026 were $38.7 million, compared to $29.3 million for the first six months of 2025. The $9.4 million year-over-year increase for the first six months resulted primarily from an increase in clinical trial expense of approximately $7.4 million, which reflects increased alisertib study activity, and an increase in internal R&D expense of approximately $2.0 million, which includes increased employee compensation and the hiring of a new executive. Total Other Income (Expenses) Total other income was $0.6 million for the second quarter of 2026, compared to total other expenses of $0.4 million for the second quarter of 2025. Total other income was $1.0 million for the first six months of 2026, compared to total other expenses of $1.2 million for the first six months of 2025. The $2.2 million year-over-year increase in other income for the first six months of 2026 resulted primarily from a decrease in interest expense, which reflects a lower debt balance as we paid down our debt principal in the three months ended June 30, 2026. Third Quarter and Full Year 2026 Financial Outlook Conference Call Puma Biotechnology will host a conference call to report its second quarter 2026 financial results and provide an update on its business and outlook at 1:30 p.m. PDT/4:30 p.m. EDT on Thursday, August 6, 2026. The call may be accessed by dialing (877) 709-8150 (domestic) or (201) 689-8354 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at https://www.pumabiotechnology.com. A replay of the call will be available shortly after completion of the call and will be archived on Puma’s website for 90 days. About Puma Biotechnology Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licensed the global development and commercialization rights to PB272 (neratinib, oral) in 2011. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX® (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX® is a registered trademark of Puma Biotechnology, Inc. In September 2022, Puma entered into an exclusive license agreement for the development and commercialization of the anti-cancer drug alisertib, a selective, small molecule, orally administered inhibitor of aurora kinase A. Initially, Puma intends to focus the development of alisertib on the treatment of small cell lung cancer and breast cancer. In February 2024, Puma initiated ALISCA®-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive-stage small cell lung cancer. In November 2024, Puma initiated ALISCA®-Breast1, a Phase II clinical trial of alisertib in combination with endocrine therapy for the treatment of patients with HER2-negative, HR-positive metastatic breast cancer. ALISCA® is a registered trademark of Puma Biotechnology, Inc. To help ensure patients have access to NERLYNX, Puma has implemented the Puma Patient Lynx support program to assist patients and healthcare providers with reimbursement support and referrals to resources that can help with financial assistance. More information on the Puma Patient Lynx program can be found at https://www.NERLYNX.com or by calling 1-855-816-5421. Further information about Puma Biotechnology may be found at https://www.pumabiotechnology.com. INDICATIONS NERLYNX® (neratinib) tablets, for oral use, is a kinase inhibitor indicated: As a single agent, for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy. In combination with capecitabine, for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer, who have received two or more prior anti-HER2 based regimens in the metastatic setting. Important Safety Information Regarding NERLYNX® (neratinib) U.S. Indication CONTRAINDICATIONS: None WARNINGS AND PRECAUTIONS: Diarrhea: Manage diarrhea through either NERLYNX dose escalation or loperamide prophylaxis. If diarrhea occurs despite recommended prophylaxis, treat with additional antidiarrheals, fluids, and electrolytes as clinically indicated. Withhold NERLYNX in patients experiencing severe and/or persistent diarrhea. Permanently discontinue NERLYNX in patients experiencing Grade 4 diarrhea or Grade ≥ 2 diarrhea that occurs after maximal dose reduction. Hepatotoxicity: Monitor liver function tests monthly for the first 3 months of treatment, then every 3 months while on treatment and as clinically indicated. Withhold NERLYNX in patients experiencing Grade 3 liver abnormalities and permanently discontinue NERLYNX in patients experiencing Grade 4 liver abnormalities. Embryo-Fetal Toxicity: NERLYNX can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception. ADVERSE REACTIONS: The most common adverse reactions (reported in ≥ 5% of patients) were: NERLYNX as a single agent: diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increased, nail disorder, dry skin, abdominal distention, epistaxis, weight decreased, and urinary tract infection. NERLYNX in combination with capecitabine: diarrhea, nausea, vomiting, decreased appetite, constipation, fatigue/asthenia, weight decreased. To report SUSPECTED ADVERSE REACTIONS, contact Puma Biotechnology, Inc. at 1-844-NERLYNX (1-844-637-5969) or FDA at 1-800-332-1088 or www.fda.gov/medwatch. DRUG INTERACTIONS: Gastric acid reducing agents: Avoid concomitant use with proton pump inhibitors. Separate NERLYNX by at least 2 hours before or 10 hours after H2-receptor antagonists. Or separate NERLYNX by at least 3 hours after antacids. Strong CYP3A4 inhibitors: Avoid concomitant use. P-gp and moderate CYP3A4 dual inhibitors: Avoid concomitant use. Strong or moderate CYP3A4 inducers: Avoid concomitant use. Certain P-gp substrates: Monitor for adverse reactions of P-gp substrates for which minimal concentration change may lead to serious adverse reactions when used concomitantly with NERLYNX. USE IN SPECIFIC POPULATIONS: Lactation: Advise women not to breastfeed. Please see Full Prescribing Information for additional safety information. Forward-Looking Statements This press release contains forward-looking statements, including statements regarding Puma’s anticipated milestones and estimates of future financial results for the third quarter and full year 2026. All forward-looking statements involve risks and uncertainties that could cause Puma’s actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, which include, but are not limited to, any adverse impact on Puma’s business or the global economy and financial markets, any changes in Puma’s product candidates’ regulatory approvals, results from Puma’s clinical trials, any litigation involving Puma, any changes to Puma’s in-licensed intellectual property and the risk factors disclosed in the periodic and current reports filed by Puma with the Securities and Exchange Commission from time to time, including Puma’s Annual Report on Form 10-K for the year ended December 31, 2025 and subsequent filings. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Puma assumes no obligation to update these forward-looking statements, except as required by law. (Financial Tables Follow) Use of Non-GAAP Measures In addition to operating results as calculated in accordance with GAAP, Puma uses certain non-GAAP financial measures when planning, monitoring, and evaluating operational performance. The following table presents Puma’s net income and net income per share calculated in accordance with GAAP and as adjusted to remove the impact of stock-based compensation expense. For the three months and six months ended June 30, 2026, stock-based compensation represented approximately 5.4% and 5.2% of operating expenses, respectively, and 4.9% and 5.6% for the same periods in 2025, in each case excluding cost of sales and acquired in-process research and development. Puma’s management believes that these non-GAAP financial measures are useful to enhance understanding of Puma’s financial performance, are more indicative of its operational performance, and facilitate a better comparison among fiscal periods. These non-GAAP financial measures are not, and should not be viewed as, substitutes for GAAP reporting measures. View source version on businesswire.com: https://www.businesswire.com/news/home/20260806108241/en/ Contacts Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc., +1 424 248 [email protected] [email protected] David Schull, Russo Partners, +1 212 845 [email protected]

Puma Biotech (PBYI) came out with quarterly earnings of $0.19 per share, beating the Zacks Consensus Estimate of $0.1 per share. This compares to earnings of $0.15 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +90.00%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $0.13 per share when it actually produced a loss of $0.04, delivering a surprise of +69.23%. Over the last four quarters, the company has surpassed consensus EPS estimates four times. Puma Biotech, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $56.5 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 6.27%. This compares to year-ago revenues of $52.4 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Puma Biotech shares have added about 34.3% since the beginning of the year versus the S&P 500's gain of 12.8%. While Puma Biotech has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Puma Biotech was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $0.16 on $53.12 million in revenues for the coming quarter and $0.48 on $224.53 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 44% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. Another stock from the same industry, TELA Bio, Inc. (TELA), has yet to report results for the quarter ended June 2026. The results are expected to be released on August 10. This company is expected to post quarterly loss of $0.17 per share in its upcoming report, which represents a year-over-year change of +22.7%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. TELA Bio, Inc.'s revenues are expected to be $20 million, down 1% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Puma Biotechnology, Inc. (PBYI) : Free Stock Analysis Report TELA Bio, Inc. (TELA) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

The market expects Puma Biotech (PBYI) to deliver a year-over-year decline in earnings on higher revenues when it reports results for the quarter ended June 2026. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates. The stock might move higher if these key numbers top expectations in the upcoming earnings report, which is expected to be released on August 6. On the other hand, if they miss, the stock may move lower. While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise. This biopharmaceutical company is expected to post quarterly earnings of $0.10 per share in its upcoming report, which represents a year-over-year change of -33.3%. Revenues are expected to be $53.17 million, up 1.5% from the year-ago quarter. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP. Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell). For Puma Biotech, the Most Accurate Estimate is lower than the Zacks Consensus Estimate, suggesting that analysts have recently become bearish on the company's earnings prospects. This has resulted in an Earnings ESP of -68.42%. On the other hand, the stock currently carries a Zacks Rank of #3. So, this combination makes it difficult to conclusively predict that Puma Biotech will beat the consensus EPS estimate. While calculating estimates for a company's future earnings, analysts often consider to what extent it has been able to match past consensus estimates. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number. For the last reported quarter, it was expected that Puma Biotech would post a loss of$0.13 per share when it actually produced a loss of -$0.04, delivering a surprise of +69.23%. Over the last four quarters, the company has beaten consensus EPS estimates four times. An earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss. That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported. Puma Biotech doesn't appear a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release. Arcutis Biotherapeutics, Inc. (ARQT), another stock in the Zacks Medical - Biomedical and Genetics industry, is expected to report earnings per share of $0.09 for the quarter ended June 2026. This estimate points to a year-over-year change of +169.2%. Revenues for the quarter are expected to be $121.85 million, up 49.5% from the year-ago quarter. The consensus EPS estimate for Arcutis Biotherapeutics has remained unchanged over the last 30 days. However, a higher Most Accurate Estimate has resulted in an Earnings ESP of +52.94%. When combined with a Zacks Rank of #2 (Buy), this Earnings ESP indicates that Arcutis Biotherapeutics will most likely beat the consensus EPS estimate. Over the last four quarters, the company surpassed consensus EPS estimates three times. Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Puma Biotechnology, Inc. (PBYI) : Free Stock Analysis Report Arcutis Biotherapeutics, Inc. (ARQT) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

LOS ANGELES, July 23, 2026--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, will host a conference call at 1:30 p.m. PT/4:30 p.m. ET on Thursday, August 6, 2026, following the release of its second quarter 2026 financial results. The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at https://www.pumabiotechnology.com. A replay of the call will be available approximately one hour after completion of the call and will be archived on Puma’s website for 90 days. About Puma Biotechnology Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licensed the global development and commercialization rights to PB272 (neratinib, oral) in 2011. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX® (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX® is a registered trademark of Puma Biotechnology, Inc. In September 2022, Puma entered into an exclusive license agreement for the development and commercialization of the anti-cancer drug alisertib, a selective, small molecule, orally administered inhibitor of aurora kinase A. Initially, Puma intends to focus the development of alisertib on the treatment of small cell lung cancer and breast cancer. In February 2024, Puma initiated ALISCA®-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive-stage small cell lung cancer. In November 2024, Puma initiated ALISCA®-Breast1, a Phase II clinical trial of alisertib in combination with endocrine therapy for the treatment of patients with HER2-negative, HR-positive metastatic breast cancer. ALISCA® is a registered trademark of Puma Biotechnology, Inc. Further information about Puma Biotechnology may be found at https://www.pumabiotechnology.com. View source version on businesswire.com: https://www.businesswire.com/news/home/20260723917628/en/ Contacts Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc., +1 424 248 [email protected]@pumabiotechnology.com David Schull, Russo Partners, +1 212 845 [email protected]

Investors were disappointed with the weak earnings posted by Puma Biotechnology, Inc. (NASDAQ:PBYI ). Despite the soft profit numbers, our analysis has optimistic about the overall quality of the income statement. This technology could replace computers: discover the 20 stocks are working to make quantum computing a reality. Many investors haven't heard of the accrual ratio from cashflow, but it is actually a useful measure of how well a company's profit is backed up by free cash flow (FCF) during a given period. In plain english, this ratio subtracts FCF from net profit, and divides that number by the company's average operating assets over that period. You could think of the accrual ratio from cashflow as the 'non-FCF profit ratio'. That means a negative accrual ratio is a good thing, because it shows that the company is bringing in more free cash flow than its profit would suggest. While having an accrual ratio above zero is of little concern, we do think it's worth noting when a company has a relatively high accrual ratio. To quote a 2014 paper by Lewellen and Resutek, "firms with higher accruals tend to be less profitable in the future". Over the twelve months to March 2026, Puma Biotechnology recorded an accrual ratio of -0.60. Therefore, its statutory earnings were very significantly less than its free cashflow. Indeed, in the last twelve months it reported free cash flow of US$54m, well over the US$24.4m it reported in profit. Puma Biotechnology's free cash flow improved over the last year, which is generally good to see. That might leave you wondering what analysts are forecasting in terms of future profitability. Luckily, you can click here to see an interactive graph depicting future profitability, based on their estimates. As we discussed above, Puma Biotechnology's accrual ratio indicates strong conversion of profit to free cash flow, which is a positive for the company. Because of this, we think Puma Biotechnology's underlying earnings potential is as good as, or possibly even better, than the statutory profit makes it seem! And on top of that, its earnings per share have grown at an extremely impressive rate over the last three years. At the end of the day, it's essential to consider more than just the factors above, if you want to understand the company properly. So if you'd like to dive deeper into this stock, it's crucial to consider any risks it's facing. To help with this, we've discovered 2 warning signs (1 makes us a bit uncomfortable!) that you ought to be aware of before buying any shares in Puma Biotechnology. This note has only looked at a single factor that sheds light on the nature of Puma Biotechnology's profit. But there are plenty of other ways to inform your opinion of a company. Some people consider a high return on equity to be a good sign of a quality business. While it might take a little research on your behalf, you may find this free collection of companies boasting high return on equity, or this list of stocks with significant insider holdings to be useful. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.