Earnings call transcript: Puma Biotech Q1 2025 results miss forecasts

Puma Biotechnology Inc. (PBYI), a $151 million market cap biotech company, reported its first quarter 2025 financial results, revealing earnings per share (EPS) of $0.06, which fell short of expectations. The company reported $46 million in revenue, below the forecasted $47.5 million. Despite the miss, Puma Biotech’s stock experienced a 4.23% increase in after-hours trading, closing at $3.20. According to InvestingPro analysis, the company appears undervalued based on its current Fair Value metrics.

Key Takeaways

• Puma Biotech’s Q1 2025 revenue fell short of expectations, impacting stock performance.
• The company anticipates full-year NERLYNX product revenue between $192 million and $198 million.
• Ongoing trials and product innovations remain a focal point for future growth.
• The stock saw a positive reaction post-earnings, rising 4.23% in after-hours trading.

Company Performance

Puma Biotechnology’s Q1 2025 results showed a decline in NERLYNX net product revenue, which dropped from $54.4 million in Q4 2024 to $43.1 million. The company continues to focus on expanding its market reach and enhancing its product pipeline through ongoing trials and strategic partnerships.

Financial Highlights

• Revenue: $46 million, down from the forecasted $47.5 million.
• Earnings per share: $0.06, below expectations.
• Cash and equivalents: $93 million as of March 31, 2025.
• Full-year 2025 net income guidance: $23 million to $28 million.

Earnings vs. Forecast

Puma Biotech reported an EPS of $0.06, missing the market forecast, which contributed to a revenue shortfall of $1.5 million from expectations. This marks a significant deviation from previous quarters where the company met or exceeded forecasts.

Market Reaction

Despite missing earnings expectations, Puma Biotech’s stock rose by 4.23% in after-hours trading, reaching $3.20. This positive movement contrasts with the stock’s 52-week high of $5.20 and low of $2.225. Analyst price targets range from $2 to $7, suggesting significant potential upside. The market’s response aligns with InvestingPro’s analysis, which gives the company a "GREAT" overall financial health score of 3.53 out of 5, particularly strong in profitability and relative value metrics.

Outlook & Guidance

Puma Biotech projects Q2 2025 NERLYNX product revenue to be between $48 million and $50 million, with an anticipated net income of $4 million to $6 million. The company remains committed to exploring in-licensing or acquisition opportunities to bolster its pipeline.

Executive Commentary

CEO Ellen Auerbach stated, "We continue to remain focused on NERLYNX sales trends in 2025 and beyond." VP of Marketing Heather Blaber emphasized the company’s efforts to increase NERLYNX utilization among patients at risk of recurrence.

Risks and Challenges

• Declining NERLYNX sales could impact future revenue growth.
• Competitive pressures from other oncology treatments.
• Potential delays in clinical trials or regulatory approvals.
• Macroeconomic factors affecting healthcare spending.

Q&A

During the earnings call, analysts inquired about the manufacturing location for alosertib, which is primarily in the U.S. The company also discussed the positive impact of Medicare Part D redesign on patient affordability and promising early data on neratinib combination therapy, particularly in pancreatic cancer.

Full transcript - Puma Biotechnology Inc (PBYI) Q1 2025:

Sherry, Conference Call Operator: Good afternoon. My name is Sherry, 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. As a reminder, this call is being recorded.

I would now like to turn the conference over to Mary Anne O’Hanison, Senior Director of Investor Relations for Puma Biotechnology. Thank you. You may begin your conference.

Mary Anne O’Hanison, Senior Director of Investor Relations, Puma Biotechnology: Thank you, Sherry. Good afternoon and welcome to Puma’s conference call to discuss our earnings results for the first quarter of twenty twenty five. Joining me on the call today are Ellen Auerbach, Chief Executive Officer, President and Chairman of the Board of Puma Biotechnology Maximo Nougues, Chief Financial Officer Jeff Ludwig, Chief Commercial Officer Heather Blaber, Vice President of Marketing and Jeff Storms, Vice President of Sales. After the close today, Puma issued a news release detailing earnings results for first quarter twenty twenty five. That news release, the slides that Jeff will refer to and a webcast of this call are accessible via the homepage in the Investors section of our website at pumabiotechnology.com.

The webcast and presentation slides will be archived on our website and available for replay for the next ninety 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 ks for the year ended 12/31/2024. 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, 05/08/2025.

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 a substitute for, our GAAP financial measures. Please refer to our first quarter twenty twenty five earnings release for a reconciliation of our GAAP to non GAAP results. I will now turn the call over to Alan.

Ellen Auerbach, Chief Executive Officer, President and Chairman, Puma Biotechnology: Thank you, Mary Anne, and thank you all for joining our call today. Today, Puma reported total revenue for the first quarter of twenty twenty five of $46,000,000 Total revenue includes product revenue net, which consists entirely of NERLYNX sales as well as royalties from our sub licensees. Product revenue net was $43,100,000 in the first quarter of twenty twenty five, a decline from the $54,400,000 reported in Q4 twenty twenty four and an increase from the $40,300,000 reported in Q1 of twenty twenty four. Product revenue for the first quarter of twenty twenty five was impacted by approximately $4,700,000 of inventory decrease at our specialty pharmacies and specialty distributors. Royalty revenue was $2,900,000 in the first quarter of twenty twenty five compared to $4,700,000 in Q4 twenty twenty four and $3,500,000 in Q1 twenty twenty four.

We reported 2,338 bottles of NERLYNX sold in the first quarter of twenty twenty five, a decrease of six twenty six from the 2,964 bottles sold in Q4 twenty twenty four. In Q1 twenty twenty five, we estimate that inventory decreased by two fifty one bottles. In Q1 twenty twenty five, new prescriptions or NRx were up approximately 6% compared to Q4 twenty twenty four and total prescriptions were down approximately 9% compared to Q4 twenty twenty four. Jeff will provide further details in his comments and slides. I will now provide a clinical review of the quarter, then Jeff Ludwig as well as Heather Blaber and Roger Storms will add additional color on NERLYNX commercial activities.

Maximo Nougues will follow with highlights of the key components of our financial statements for the first quarter of twenty twenty five. At the recent American Association for Cancer Research or AACR Annual Meeting, interim data from an ongoing Phase one trial, which is NCT05372 that is sponsored by the National Cancer Institute evaluating the combination of neratinib and fam trastuzumab deruxtecan or in HER2 in patients with metastatic solid tumors was presented. The Phase one data includes patients with metastatic solid tumors harboring HER2 overexpression, IHC three plus ErbB2 amplifications or activating HER2 mutations. In the poster presentation, patients received study treatments. Dose level one had seven patients, dose level two had four patients, dose level three had nine patients.

The most common treatment emergent adverse events of any grade included nausea, n equals fifteen or 75%, diarrhea n equals fifteen or 75%, fatigue n equals thirteen or 65% and hypokalemia N=eleven or fifty five percent. Grade three treatment emergent adverse events that occurred in more than two patients included anemia N=six or thirty percent, diarrhea N=four or twenty percent and hypokalemia N equals three or fifteen percent. The only grade four treatment related adverse event was neutropenia that incurred one patient which was five percent one DLT which was acute kidney injury was observed at dose level one, no DLTs were observed at dose level two and one DLT was observed which was fatigue leading to early discontinuation at dose level three. Three patients developed grade one pneumonitis or interstitial lung disease ILD, two patients at dose level one and one at dose level three. The proportion of reported treatment emergent adverse events was lower at higher doses.

Of the 15 response evaluable patients by resist, four patients had a partial response including patients with gastroesophageal which was N equal to and it was one HER2 positive IHC three plus and one HER2 mutated. Pancreatic which was one patient who was an IHC three plus and ovarian which was one patient who was also a three plus and the ovarian was a confirmed response. Most notably three of five patients with advanced pancreatic cancer were observed to have tumor regression, one PR for 13 cycles, which is ongoing and two with stable disease consisting of one patient with a 29.4% tumor regression for nine cycles and one patient with a 13.3% regression for eight cycles. Dose level three which consisted of trastuzumab deruxtecan at five point four mgs per kg and neratinib at one hundred and twenty mgs in week one, one hundred sixty in week two and two forty in week three and onward was selected as the recommended Phase two dose. Part two of the study, which consists of a pharmacodynamic evaluation of trastuzumab deruxtecan with neratinib in 12 patients open to enrollment in March of twenty twenty five.

Patients with advanced solid tumor and amplification or overexpression or HER2 mutation will be enrolled. We look forward to updating the data from this trial to be presented likely in 2026. In addition, Puma currently has two ongoing Phase two studies of our investigational drug alosertib, the ELISCA BREST1 trial, which is a Phase two trial of alosertib in combination with endocrine treatment in patients with HER2 negative hormone receptor positive metastatic breast cancer and ELISCA LUNG-one, which is a Phase two study looking at the efficacy of alisertib monotherapy in patients with small cell lung cancer. As a reminder, the ALISCA BREST-one trial investigates alisertib in combination with endocrine treatment, which consists of either anastrozole, exemestane, letrozole, fulvestrant or tamoxifen in patients with HER2 negative hormone receptor positive metastatic breast cancer. Patients must be chemotherapy naive, have been previously treated with CDK4six inhibitors and received at least two prior lines of endocrine therapy in the recurrent or metastatic setting to be eligible for the trial.

Patients are being dosed with alasertib given at either thirty mg, forty mg or fifty mg twice daily BID on days one to three, eight to ten and fifteen to seventeen on a twenty eight day cycle in combination with the endocrine therapy of the investigator’s choice. Patients must not have been previously treated with the endocrine treatment in the metastatic setting that is being given in combination with elicertib in the trial. Primary efficacy endpoints will include objective response rate, duration of response, disease control rate and progression free survival. As a secondary objective, the company will be evaluating each of these efficacy endpoints within biomarker subgroups in order to determine whether any biomarker subgroup correlates with better efficacy as has been seen in the preclinical and clinical studies in other cancers including breast cancer and small cell lung cancer. The company will then look to focus the future clinical development of valsertib in combination with endocrine for patients with HER2 negative hormone receptor positive breast in patients with these biomarkers.

The trial was initiated in late November twenty twenty four. There are currently 26 sites in The U. S. And 12 sites in Europe that have been activated for the trial and the trial is enrolling ahead of expectations. There are currently 28 patients enrolled in the trial, one expected to be enrolled this week and six additional patients in screening.

We are looking to have interim data from this trial later in 2025. With respect to the ELYSCA lung study, as discussed in the last conference call, the company believes the data obtained to date from the ELYSCA lung one trial is providing a preliminary indication of potentially better activity in patients with biomarkers where the aurora kinase pathway plays a role. The most recent analysis of the pharmacokinetic data from the ELYSCA LUNG-one trial suggests that we are seeing a lower PK of alisertib in the ELYSCA LUNG trial compared to the previous Phase two study of alasertib monotherapy in small cell lung cancer patients that was published in The Lancet Oncology. The company is in the process of amending the protocol to increase the dose of alasertib from fifty mg to sixty mg, which the company believes will increase the PK of the drug to levels closer to what was seen in the prior Phase two trial. The company looks to have additional interim data from this trial later in 2025.

As mentioned on prior earnings calls and in response to investor questions, Puma continues to evaluate several drugs to potentially in license or acquire that would allow the company to diversify itself and leverage Puma’s existing R and D, regulatory and commercial infrastructure. The company will keep investors updated on this as it progresses. I will now turn the call over to Jeff Ludwig, Puma’s Chief Commercial Officer for a review of our commercial performance during the quarter.

Jeff Ludwig, Chief Commercial Officer, Puma Biotechnology: Thanks, Alan. Appreciate it, and thanks to everyone for joining our first quarter earnings call. Before I move into the commercial review, just a reminder that I will be making forward looking statements. The commercial team remains focused on expanding the utilization of NERLYNX with a primary emphasis on patients who are at increased risk of reoccurrence. The marketing team has recently revised the core sales aid aligned with this strategy.

In addition, the team has continued their emphasis on improving clinical education and engagement through non personal promotion and developed a new patient resource brochure designed to improve persistence and compliance throughout a patient’s NERLYNX therapy. Sales team is working very hard on expanding overall HCP reach and frequency with an emphasis on increasing engagement when treatment decisions are being made. In Q1 of twenty twenty five, call activity was flat year over year and down about 2% quarter over quarter driven by an increased number of vacancies. We expect that trend to improve as these vacancies are filled. Heather Blaber, our VP of Marketing and Roger Storms, our VP of Sales have joined us during this call and will add some additional details in a few moments.

Let me now transition to some of the commercial slides where I will provide some additional specifics around performance. Slide three 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. In regards to the overall distribution of our business, in Q1 of twenty twenty five, about 67% of our business was purchased through the SP channel and the remaining 33% was purchased through the SD channel. We are seeing some stronger growth in the SD channel driven by two main factors: number one, increased sales in the GPO segment and two, some increasing 340B purchasing. Turning to slide four, NERLYNX net revenue in Q1 of twenty twenty five was $43,100,000 which represents a decline of about $11,300,000 from the $54,400,000 we reported in Q4 of twenty twenty four and an increase of 2,800,000 from the $40,300,000 we reported in Q1 of twenty twenty four.

The significant change in quarterly revenue was driven largely by anticipated seasonal inventory changes and higher gross to net expenses in the prior quarter. 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 Q1 of twenty twenty five, we estimate that inventory decreased by about $4,700,000 As a comparator, we estimate that inventory increased by about $3,700,000 in Q4 of twenty twenty four and decreased by about $2,000,000 in Q1 of twenty twenty four. On Slide five, Slide five shows Q1 twenty twenty five ex factory bottle sales and also provides a year over year and a quarter over quarter comparison. In Q1 of twenty twenty five, NERLYNX ex factory bottle sales were 2,338, which represents an approximate 21% decrease quarter over quarter and a 3% decrease year over year.

It is typical for us to see inventory increase in Q4 and then subsequently decline in Q1. Similar to the prior slide, let me specifically call out the inventory changes from a bottle perspective. Q1 of twenty twenty five, we estimate that inventory decreased by two fifty one bottles. As a comparator, we estimate that inventory increased by two zero four bottles in Q4 of twenty twenty four and decreased by 120 bottles in Q1 of twenty twenty four. Let me take a moment to provide some additional metrics regarding our first quarter performance and then I’ll turn the call over to Heather and Roger to share their insights into sales and marketing.

In Q1, we saw enrollments increase about 6% quarter over quarter, but decline about 8% year over year. We have seen some continued enrollment softness in April, which we are monitoring very closely. New patient starts or NRx followed a similar pattern growing about 6% quarter over quarter, but declining about 7% year over year. Turning to total prescriptions or TRx, we saw our TRx decline of about 9% quarter over quarter and a decline of about 3% year over year. Finally, let me share some specifics around demand.

In Q1, we saw demand decline about 6% quarter over quarter, but increase about 2% year over year. As mentioned earlier, we have seen stronger demand growth in the SD channel, where we saw SD demand grow about 4% quarter over quarter and about 14% year over year. Let me now turn the call over to Heather and Roger for some additional insights. Why don’t we start with Heather Blaber, our VP of Marketing. Heather, the floor is yours.

Heather Blaber, Vice President of Marketing, Puma Biotechnology: Thanks, Jeff. I appreciate the opportunity to be on this call and share some more insights into the marketing strategy and execution. As Jeff mentioned earlier, the marketing team is focused on increasing the utilization of Neuralinks with a focus on patients who are at continued risk of recurrence. We recently conducted several focus groups with community oncologists to better understand patient risk factors that are most concerning to physicians and to garner feedback on some more recent publications regarding the overall risk of recurrence. We have utilized those insights to update and revise our core sales aid and messaging with the goal of engaging physicians on a broader set of patients where the risk of recurrence is high and where we believe that NERLYNX can play an important role in helping to reduce that risk.

In addition to revising the core sales aid and messaging, we have also recently rolled out a new patient education resource designed to better support our patients throughout their recommended course of Neuralynx therapy. This educational resource will be provided to patients on a monthly basis as they receive their refills. Lastly, I know Jeff mentioned our goal of expanding the overall share of voice. The marketing team works very closely with our field leadership team to increase the engagement with oncologists through our non personal promotion, both branded and unbranded messaging. Our non promotional promotion our non personal promotion efforts target a very broad group of oncologists, and we are continually evaluating new partners and new approaches that will enhance these efforts.

I know our sales team is also heavily focused on increasing engagements with health care providers. So now I would like to take the opportunity to turn it over to our Vice President of Sales, Roger Storms, to provide some additional insights and perspective. Roger?

Roger Storms, Vice President of Sales, Puma Biotechnology: Thanks, Heather. I also appreciate the opportunity to participate on the call and share my perspective. I joined Puma in December of last year, so I’m still relatively new, but I’m very excited to be here and passionate about finding ways to better support HER2 positive breast cancer patients. My focus is on executional excellence and expanding overall share of voice. As previously mentioned, our Q1 call activity was flat year over year and down about 2% quarter over quarter, driven by a higher vacancy rate.

My expectation is that we will see an increase in our overall reach and frequency, driven by a reduction in these vacancies as well as better overall execution. I’m happy to say that we’ve made good progress on our openings and have brought in strong talent with both breast cancer experience and established relationships with key customers. In regards to executional excellence, we are focused on helping our sales reps get in front of more customers with the goal of increasing engagement when clinical decisions are being made. We’re utilizing claims data, non personal promotion feedback and piloting predictive analytics to help our teams prioritize their time and maximize their impact. Early feedback on the new marketing core sales aid has been positive and allows my team to discuss a broad group of patients, which is aligned with our goal of increasing the utilization of NERLYNX.

Jeff Ludwig, Chief Commercial Officer, Puma Biotechnology: Thanks, Roger, and thanks, Heather, for providing additional specifics and insights. Let me wrap up with just a few more slides, then I’ll turn the call over to Maximo for a more detailed financial review. Turning to Slide six. Slide six highlights the quarterly adoption of dose escalation since NERLYNX launch. In Q1, approximately seventy two percent of patients started NERLYNX at a reduced dose.

This is similar to the seventy four percent we reported in Q4 of twenty twenty four. Continued messaging and adoption of dose escalation remains an important commercial priority. Patients who are started on NERLYNX utilizing dose escalation have better persistence and compliance. We believe dose escalation coupled with the new patient education resource Heather discussed will give patients better support throughout their NERLYNX therapy and ultimately help them reduce the risk of reoccurrence. Slide seven highlights these strategic collaborations we have formed across the globe.

In Q1 of twenty twenty five, NERLYNX was launched in Libya in the extended adjuvant setting and we signed a distribution agreement with IRChem for select countries in Eastern Europe and Central Asia. We really appreciate the excellent work being done by our partners around the globe and look forward to supporting their continued success moving forward. Let me wrap up by thanking the entire Puma team once again for the continued passion and commitment for helping patients and their families battling breast cancer. This disease can have devastating effects and we know more can be done and more needs to be done. I’ll now turn the call over to Maximo for a review of our full financial results.

Maximo?

Maximo Nougues, Chief Financial Officer, Puma Biotechnology: Thanks, Jeff. I will begin with a brief summary of our financial results for the first quarter of twenty twenty five. Please note that I will make comparisons to Q4 twenty twenty four, which we believe is a better indication of our progress as a commercial company than year over year comparisons. For more information, I recommend that you refer to our first quarter twenty twenty five ten Q, which will be filed today and includes our consolidated financial statements. For the first quarter of twenty twenty five, we reported net income based on GAAP of $3,000,000 or $06 per share.

This compares to net income in Q4 twenty twenty four of nineteen point three million dollars or $0.39 per share. In the fourth quarter of twenty twenty four, we released a portion of our valuation allowance resulting in a non cash deferred income tax benefit of $7,100,000 The valuation allowance was established to offset our deferred tax assets, which are primarily related to our historical losses. This significantly increased our net income for the fourth quarter. On a non GAAP basis, which is adjusted to remove the impact of stock based compensation expense, we reported net income of 5,000,000 or $0.10 per basic and diluted share for the first quarter of twenty twenty five. Gross revenue from NERLYNX sales was $54,400,000 in Q1 twenty twenty five and $66,500,000 in Q4 twenty twenty four.

Alan mentioned that net product revenue from NERLYNX sales was $43,100,000 a decrease from the $54,400,000 reported in Q4 twenty twenty four. The lower net revenue was driven mostly by seasonality of inventory fluctuation and higher gross to net expenses than prior quarter. Inventory drawdown by our distributors was approximately $4,700,000 in Q1 versus an increase of approximately $3,700,000 in Q4 twenty twenty four. Royalty revenue totaled $2,900,000 in the first quarter of twenty twenty five compared to $4,700,000 in Q4 twenty twenty four. Our gross to net adjustment in Q1 twenty twenty five was about 20.8% compared to 18.2% gross to net adjustment reported in Q4 twenty twenty four.

COFTO sales for Q1 twenty twenty five declined to $10,600,000 and includes $2,400,000 for the amortization of intangible assets related to our neratinib license. Cost of sales for Q4 twenty twenty four was $13,900,000 Going forward, we will continue to recognize amortization of our milestones to the licensors about $2,400,000 per quarter as cost of sales. For fiscal year twenty twenty five, Puma anticipates the net NERLYNX product revenue will be in the range of 192,000,000 to $198,000,000 We also anticipate that our gross to net adjustment for the full year 2025 will be between 20.521.5%. In addition, for fiscal year twenty twenty five, we anticipate receiving royalties from our partners around the world in the range of 20,000,000 to $24,000,000 lower than $20.24 due to fewer shipment expected to China as our partner works through regulatory transitions during the first several quarters of twenty twenty five. We don’t expect license revenue in 2025.

We also expect that net income for the full year will be in the range of 23,000,000 to $28,000,000 We are not forecasting any potential release of any additional tax asset valuation allowance in our net income estimate at this time. However, this will be evaluated on an ongoing basis. We will continue to keep investors updated on this as it progresses. At this time, we do not believe that 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, shifting 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 costs account for a mid to high single digit percentage of our total cost of goods sold. We anticipate that for Q2 twenty twenty five, NERLYNX product revenue net will be in the range of $48,000,000 to $50,000,000 Also, expect Q2 royalty revenue will be in the range of 2,000,000 to 3,000,000 and no license revenue. We further estimate that the gross to net adjustment in Q2 twenty twenty five will be approximately 20% to 21.5. Puma anticipates Q2 net income between $4,000,000 and $6,000,000 SG and A expenses were $17,600,000 in the first quarter of twenty twenty five compared to $16,600,000 in the fourth quarter of twenty twenty four. SG and A expenses included non cash charges for stock based compensation of $1,200,000 for Q1 and $1,300,000 for Q4 twenty twenty four.

Research and development expenses were $13,800,000 in the first quarter of twenty twenty five, a decrease from $15,200,000 in the fourth quarter of twenty twenty four. R and D expenses included non cash charges for stock based compensation of $800,000 in the first quarter of twenty twenty five compared to $500,000 in the fourth quarter of twenty twenty four. On the expense side, Puma anticipates flat to slightly lower total operating expenses in 2025 compared to 2024. More specifically, we anticipate SG and A expenses to decrease by 5% to 10% and R and D expenses to increase by 10% to 15% year over year. In the first quarter of twenty twenty five, Puma reported cash burn of approximately $7,800,000 This compares to cash burn of approximately $4,300,000 in Q4 twenty twenty four.

Please note that during Q1, we made our fourth principal loan payment of $11,100,000 related to our obligation with Atheria. As a result of this, our total outstanding principal debt balance decreased to approximately 56,000,000 At 03/31/2025, we had approximately $93,000,000 in cash, cash equivalents and marketable securities versus about $101,000,000 at year end in 2024. Our accounts receivable balance was $24,200,000 Our accounts receivables terms range between ten and sixty eight days, while our days sales outstanding are about fifty days. We estimate that as of 03/31/2025, our distribution network maintained approximately three 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 expenses.

Ellen Auerbach, Chief Executive Officer, President and Chairman, Puma Biotechnology: Thanks, Maximo. Puma’s senior management in cooperation with the Board of Directors continues to remain focused on NERLYNX sales trends in 2025 and beyond and recognizes its fiscal responsibility to the shareholders to continue to maintain positive net income. We believe that the positive net income that was seen in fiscal years 2023 and 2024 resulted from the financial discipline across the company over the last few years. The expense reductions that we have previously performed and continue to perform are also a major contributor to the positive net income that the company achieved in Q1 twenty twenty five and the company is guiding to for full year 2025. 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. It continues to remain a significant unmet medical need for patients battling breast cancer, lung cancer and other solid tumors. We at Puma are committed and passionate about finding more effective ways at 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 and A.

Operator?

Sherry, Conference Call Operator: Thank you. We will now begin the question and answer Our first question is from Divya Rao with Cowen and Company. Please proceed.

Divya Rao, Analyst, Cowen and Company: Hi, Alan. Thanks for taking my questions. This is Divya on for Mark. I just had two questions on Alosertib. One, I guess, you talk about where the Alosertib IP is held?

Is it in Ireland? Is it in The U. S? And then also manufacturing, the comments that you made, was that just related to NERLYNX manufacturing? Or is that similar for Alcertib as well?

And then I have a second question.

Ellen Auerbach, Chief Executive Officer, President and Chairman, Puma Biotechnology: Hi, Divya. Thank you for the question. So in terms of the IP, we actually have a license to the IP from Takeda. I need to get back to you on where it is physically located. The origin of Alacerdib is that it was originally developed by Millennium, which was here in The United States.

I’m assuming that’s where it is, but I don’t have that information in front of me. So let me get back to you on that. It’s a great question. I just don’t have the information in front of me.

Mary Anne O’Hanison, Senior Director of Investor Relations, Puma Biotechnology: Sure. No worries.

Ellen Auerbach, Chief Executive Officer, President and Chairman, Puma Biotechnology: Now on the manufacturing, I believe it is mostly done in The U. S. If I’m remembering this correctly, currently. Now obviously, we’re not at commercial scale and we obviously will take into account tariffs and future tariffs and things like that in the future. But I believe right now, my remembrance of this is that we’re doing it all in The U.

S.

Divya Rao, Analyst, Cowen and Company: That’s helpful. Thank you.

Ellen Auerbach, Chief Executive Officer, President and Chairman, Puma Biotechnology: Did you have another question on the IP? Yes, I kind of cut you off there. I apologize.

Divya Rao, Analyst, Cowen and Company: No worries. No worries. I think you answered it. Thank you.

Ellen Auerbach, Chief Executive Officer, President and Chairman, Puma Biotechnology: Thank you.

Sherry, Conference Call Operator: Our next question is from Gina Wang with Barclays. Please proceed.

Kung Hwang, Analyst, Barclays: Hi. This is Kung Hwang on behalf of Gina Wang from Barclays. We have few questions. For elicertib, lung cancer Phase two trial, you just mentioned the protocol amendment for dose increase. Could you confirm whether the interim data readout will still be later this year?

And in addition to the PK data, how did the response data looks like based on the current dose? Second question is for the Neonix Phase one data presented at SCCR twenty five. So some tumor types like pancreatic cancer showed a better response than others. How would you select a tumor type moving forward? And what magnitude of PFS improvement expected based on the response data?

And lastly, we would like to ask your view on the impact from the Medicare Part D redesign and also the new CBERD Director and the potential impact on the drug approval path? Thank you.

Ellen Auerbach, Chief Executive Officer, President and Chairman, Puma Biotechnology: Let me handle the first two. With regard to the small cell lung cancer, so we are amending the protocol to go from fifty to sixty milligrams in the prior monotherapy trials of alosertib. If I remember correctly, they went up as high as one hundred milligrams. So I think we’re assuming we’re going to be okay to go up to sixty. I don’t have the data in front of me in terms of what we would expect in terms obviously, we haven’t dosed the patients at that level yet.

So I don’t have the data in front of me in terms of what we’d expect in terms of changes in response rates and things like that. In terms of the biomarkers, again, I don’t have the data in front of me. We did definitely see better activity in the patients where the aurora kinase pathway played a role. We would expect we would probably see something similar to that in at the higher doses as well. We still are planning to have data later this year.

Obviously, quicker we can get the amendment done in enrolled patients, the more patients at sixty milligrams we can have. So I can’t really speculate on that right now. With regard to the NERLYNX Phase one, you are correct that we did tend to see more activity in the combination of neratinib with in HER2. The reason for that is mechanistically based, which is that neratinib being an irreversible HER2 inhibitor, it internalizes the HER2 receptor. So because of that, if you have an ADC, perception is what you’re doing is you’re bringing more of the ADC into the cell.

That may be why we are seeing in tumor types where you historically have not seen much activity within HER2 like pancreatic, we’re seeing the better activity with combination. Not clear what we would expect. I think we need more data to be able to say what we expect in terms of ORR, PFS, etcetera. But there’s no question we are extremely encouraged by it. My understanding is that they’ve had quite a lot of interest in enrollment since we’ve opened the new cohorts.

So I think we’ll probably have some more data on that to talk about later this year. And I think they’re my understanding is they’re looking to present it publicly at a scientific conference probably in first half twenty twenty six is my recollection. In terms of your commentary on the FDA, that CBER we go through CDER, so not a whole lot we can really add in value. And if you repeat your question on the Medicare please?

Kung Hwang, Analyst, Barclays: Yes. So your view on the impact from Medicare Part D redesign in 2026 to 2027?

Jeff Ludwig, Chief Commercial Officer, Puma Biotechnology: So in terms of you’re talking about the Medicare redesign, it was part of the IRA, is that what you’re asking about?

Kung Hwang, Analyst, Barclays: Yes.

Jeff Ludwig, Chief Commercial Officer, Puma Biotechnology: Yes. So, yes, great question. So we’ve been paying attention to that. What we’ve seen from the IRA portion is that co pay for patients have actually declined somewhat in 2025 and we expect them to decline in ’26 as well. So we’ve actually seen an increase in the percent of our business going through Medicare and a subsequent slight decrease in that going to free goods.

So it’s actually been helpful to us and it’s made it slightly more affordable for patients to get on and stay on NERLYNX. Does that answer your Yes. Thank you.

Kung Hwang, Analyst, Barclays: Yes. Thank you.

Sherry, Conference Call Operator: This concludes our question and answer session. I would like to turn the conference call back over to Mary Anne for closing remarks.

Mary Anne O’Hanison, Senior Director of Investor Relations, Puma Biotechnology: Thank you all for joining us today. As a reminder, this call may be accessed via replay of the webcast at pumaspiotechnology.com beginning later today. Have a good evening.

Sherry, Conference Call Operator: Ladies and gentlemen, thank you for participating in today’s conference call. This concludes our program. Everybody have a great day. You may now disconnect.

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