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DATE
Thursday, Aug. 6, 2026 at 4:30 p.m. ET
CALL PARTICIPANTS
- 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
TAKEAWAYS
- Total Revenue -- $56.5 million, reflecting growth from $52.4 million in the second quarter of 2025.
- Net Product Revenue -- $53.6 million, consisting entirely of NERLYNX sales compared to $49.2 million in the prior-year period.
- Royalty Revenue -- $2.9 million, compared to $3.2 million in the second quarter of 2025 and $2.8 million in the first quarter of 2026.
- GAAP Net Income -- $8.2 million or $0.16 per diluted share, up from $5.9 million or $0.12 per share in the prior-year quarter.
- Non-GAAP Net Income -- $10.1 million or $0.19 per diluted share, representing growth from $7.5 million or $0.15 per share in the second quarter of 2025.
- NERLYNX Bottle Sales -- 2,930 bottles sold ex-factory, an increase of 26% compared to the first quarter of 2026 and 12% year over year.
- U.S. NERLYNX Demand -- 2,990 bottles, growing 8% compared to the first quarter of 2026 and 11% year over year.
- SD Channel Demand -- 12% growth quarter over quarter and 32% year over year, driven by increased group purchasing organization (GPO) and 340B purchasing.
- Prescription Trends -- 7% increase in total prescriptions and a 6% decline in new prescriptions compared to the first quarter of 2026.
- Enrollment Growth -- 12% year over year and 1% quarter over quarter, reflecting increased field accountability and executional focus.
- Dose Escalation Rate -- 73% of patients, with the strategy intended to improve persistence and compliance through reduced starting doses.
- Inventory Impact -- $1.3 million estimated drawdown (57 bottles) in the second quarter of 2026, with the distribution network maintaining approximately three weeks of inventory.
- Gross-to-Net (GTN) Adjustment -- 27.9%, up from 27% in the first quarter of 2026 due to a higher Medicaid share.
- Full-Year Revenue Guidance -- $205 million to $209 million for net product revenue, raised from the prior range of $202 million to $206 million.
- Full-Year Net Income Guidance -- $17 million to $20 million, increased from the previous forecast of $16 million to $19 million.
- Full-Year Royalty Guidance -- $19 million to $22 million, lowered from the prior guidance of $20 million to $23 million.
- SG&A Expenses -- $17.5 million, with full-year expense expected to increase 1% to 2% year over year.
- R&D Expenses -- $18.9 million, with full-year expense projected to grow 34% to 37%, partially due to alisertib clinical trial progress.
- Q3 2026 Guidance -- $54 million to $56 million in net product revenue and $2 million to $2.5 million in net income.
- Cash Position -- $93.9 million in cash, cash equivalents, and marketable securities as of June 30, 2026.
- Debt Status -- $0 outstanding debt, following a final principal loan payment of $11.1 million during the second quarter.
- Manufacturing Costs -- Mid to high single digit percentage of total cost of goods sold, which management expects will mitigate the impact of evolving trade policies.
- Accounts Receivable -- $34.1 million, with daily sales outstanding above 44 days.
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RISKS
- Nougues warned that the royalty rate payable to the company under the China sublicense is subject to reduction when generic versions of NERLYNX reach a specific market share threshold, which could occur in late 2026 or 2027.
- Nougues stated, "shifts in trade policies in the United States and other countries have been rapidly evolving and are difficult to predict," noting that while current tariffs are not material, future policies could impact operations.
SUMMARY
Puma Biotechnology (PBYI -1.15%) management reported total revenue of $56.5 million for the second quarter, driven by increased year-over-year demand for NERLYNX. The company transitioned to a debt-free status following the final repayment of its Athyrium loan obligation and raised full-year guidance for both product revenue and net income. Strategic focus remains on the commercial execution of NERLYNX and the clinical development of alisertib, which is being investigated for small cell lung cancer and HER2-negative, hormone receptor-positive breast cancer. The company indicated it is also evaluating potential business development opportunities to acquire or in-license additional commercial or development-stage oncology assets.
- CEO Auerbach stated that the company amended the ALISCA-Breast1 trial protocol to "only continuing enrollment in the 40 milligram and 50 milligram dose groups" based on preliminary biomarker activity.
- The company plans to initiate ALISCA-Lung2 in the third quarter of 2026, which will evaluate alisertib in combination with paclitaxel for small cell lung cancer.
- Auerbach noted that 2026 is projected to be "the first time in the history of the launch of NERLYNX in the United States that we have seen two positive consecutive year-over-year increases in demand."
- The company increased alisertib dosing in the ALISCA-Lung1 trial to 70 milligrams twice daily, with four patients currently enrolled at that level out of 92 total participants.
- Management expects to provide additional interim data from ALISCA-Lung1 and initial data from ALISCA-Lung2 in 2027.
- CEO Auerbach indicated that Puma has the financial capacity to run Phase 3 trials for alisertib in both breast and lung cancer, potentially by staggering the starts as early as next year.
- The marketing strategy for NERLYNX continues to emphasize its dual role in reducing recurrence risk in early stage breast cancer and protecting against progression in metastatic settings.
INDUSTRY GLOSSARY
- 340B: A U.S. federal program that requires drug manufacturers to provide outpatient drugs to eligible healthcare organizations at significantly reduced prices.
- Alisertib: An investigational, orally administered selective small molecule inhibitor of aurora kinase A.
- Aurora Kinase Pathway: A signaling pathway involved in cell division that is often overexpressed in various cancers, including breast and lung cancer.
- CDK4/6 Inhibitor: A class of drugs that interrupt the growth of cancer cells by blocking specific enzymes (cyclin-dependent kinases 4 and 6).
- GTN (Gross-to-Net): The difference between the gross revenue of a product and the net revenue after accounting for discounts, rebates, and returns.
- HER2: Human epidermal growth factor receptor 2, a protein that promotes the growth of cancer cells.
- NERLYNX (neratinib): An orally administered kinase inhibitor approved for the treatment of HER2-positive breast cancer.
- TRx: Total prescriptions, which includes both new and refilled prescriptions.
Full Conference Call Transcript
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.
