Q4 2025 Puma Biotechnology Inc Earnings Call

February 26, 2026

Operator: Good morning. Oh, good afternoon, ladies and gentlemen. 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 speaker's formal remarks, there will be a question-and-answer session. If you would like to ask a question during that time, simply press the star key, then the number one on your telephone keypad. If you would like to withdraw your question, please press star two. If you should require operator assistance during the conference, please press star zero. As a reminder, this call is being recorded. I would now like to turn the conference over to Mariann Ohanesian, Senior Director of IR for Puma Biotechnology. You may begin your conference.

Speaker #5: After the speaker's formal remarks, there will be a question-and-answer session. If you would like to ask a question during that time, simply press the star key; then the number 1 on your telephone keypad.

Speaker #5: If you would like to withdraw your question, please press star 2. If you should require operator assistance during the conference, please reminder, this call is being recorded.

Speaker #5: I would now like to turn the conference over to Mariann Ohanesian, Senior Director of IR for Puma Biotechnology. You may begin your conference.

Speaker #2: Thank you, Shari. Good afternoon, and welcome to Puma's conference call. To discuss our earnings results for the fourth quarter and full year 2025. Joining me on the call today are Alan Auerbach, Chief Executive Officer; President and Chairman of the Board of Puma Biotechnology; Maximo Nougues, Chief Financial Officer; Heather Blaeber, Senior Vice President of Marketing; and Roger Storm, Senior Vice President of Sales.

Mariann Ohanesian: Thank you, Sherry. Good afternoon, welcome to Puma's conference call to discuss our earnings results for Q4 and full year 2025. Joining me on the call today are Alan Auerbach, Chief Executive Officer, President, and Chairman of the Board of Puma Biotechnology, Maximo Nougues, Chief Financial Officer, Heather Blaber, Senior Vice President of Marketing, and Roger Storms, Senior Vice President of Sales. After the close today, Puma issued a news release detailing earnings results for Q4 2025. That news release, the slides that Roger will refer to, and a webcast of this call are accessible via the homepage and investor sections of our website at pumabiotechnology.com. The webcast and presentation slides will be archived on our website and available for replay for the next 90 days.

Speaker #2: After the close today, Puma issued a news release detailing earnings results for fourth quarter 2025. That news release slides that Roger will refer to and a webcast of this call are accessible via the homepage and investor sections of our website at pumabiotechnology.com.

Speaker #2: 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 law.

Mariann Ohanesian: 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 law. Such statements are subject to risks and uncertainties. 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 for the year ended 31 December 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, 26 February 2026. Puma undertakes no obligation to revise or update any forward-looking statements regarding these circumstances after the date of this conference call, except as required by law.

Speaker #2: 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.

Speaker #2: Completing our annual report. In case of year-end at December 31, 2025. You are cautioned not to place undue reliance on these as of the date of this live conference call, February 26, 2026.

Speaker #2: Puma undertakes no obligation to revise or update any forward-looking statements to reflect events and circumstances after the date of this conference call, except as required by law.

Speaker #2: 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.

Mariann Ohanesian: 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 Q4 2025 earnings release for a reconciliation of our GAAP to non-GAAP results. I will now turn the call over to Alan.

Speaker #2: Please refer to our fourth quarter 2025 earnings release for a reconciliation of our GAAP to non-GAAP results. I will now turn the call over to Alan.

Speaker #3: Thank you, Mariann. And thank you all for joining our call today. Puma reported total revenue for the fourth quarter of 2025 of $75.5 million.

Alan Auerbach: Thank you, Mariann, and thank you all for joining our call today. Puma reported total revenue for Q4 2025 of $75.5 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 $59.9 million in Q4 2025, an increase from the $51.9 million reported in Q3 2025, and an increase from the $54.4 million reported in Q4 2024. As a reminder to investors, Puma's reported NERLYNX sales include both US net sales of NERLYNX and product supply revenues of NERLYNX to Puma's ex-US partners.

Speaker #3: Total revenue includes product revenue net which consists entirely of nearlink sales, as well as royalties from our sublicensees. Product revenue net was $59.9 million in the fourth quarter of 2025, an increase from the $51.9 million reported in Q3 2025, and an increase from the $54.4 million reported in Q4 2024.

Speaker #3: 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.

Speaker #3: Product revenue for the fourth quarter of 2025 was impacted by approximately $5.7 million of inventory billed at our specialty pharmacies and specialty distributors. Royalty revenue was $15.6 million in the fourth quarter of 2025, compared to $2.6 million in Q3 2025 and $4.7 million in Q4 2024.

Alan Auerbach: Product revenue for Q4 2025 was impacted by approximately $5.7 million of inventory billed at our specialty pharmacies and specialty distributors. Royalty revenue was $15.6 million in Q4 2025, compared to $2.6 million in Q3 2025 and $4.7 million in Q4 2024. We reported 3,298 bottles of NERLYNX sold in Q4 2025, an increase of 349 from the 2,949 bottles sold in Q3 2025. In Q4 2025, we estimate that inventory increased by approximately 343 bottles.

Speaker #3: We reported $3,298 bottles of nearlinks sold in the fourth quarter of 2025, an increase of $349 from the 2,949 bottles sold in Q3 2025.

Speaker #3: In Q4 2025, we estimate that inventory increased by approximately $343 bottles. In Q4 2025, new prescriptions were down approximately $11.4%, compared to Q3 2025, and total prescriptions were up approximately 1.4%, compared to Q3 2025.

Alan Auerbach: In Q4 2025, new prescriptions were down approximately 11.4% compared to Q3 2025, and total prescriptions were up approximately 1.4% compared to Q3 2025. Roger will provide additional details in his comments and slides. I will now provide a clinical review of the quarter, and then Heather Blaber and Roger Storms will add additional color on NERLYNX commercial activities. Massimo Nugues will follow with highlights of the key components of our financial statements for Q4 2025. As investors are aware, Puma currently has two ongoing phase II trials of alisertib. One is the ALISCA-Breast1 trial, a phase II trial of alisertib in combination with endocrine treatment in patients with HER2-negative, hormone receptor-positive, recurrent or metastatic breast cancer.

Speaker #3: Roger will provide additional

Speaker #1: Personal details in his comments and slides. I will now provide a clinical review of the quarter. Then Heather Blaber and Roger Storms will add additional color on Neuralink's commercial activities. Maximo Nougues will follow with highlights of the key components of our financial statements for the fourth quarter of 2025.

Speaker #1: As investors are aware , Puma currently has two ongoing phase two trials of Alisertib . One is the Alaska Breast one trial , a phase two trial of Alisertib in combination with endocrine treatment in patients with Her2 negative hormone receptor positive , recurrent or metastatic breast cancer And number two , Eliska lung one , a phase two trial looking at the efficacy of Alisertib monotherapy in patients with small cell lung cancer As a reminder , the breast one 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 recurrent or metastatic setting , have had prior treatment with a Cdk4 six inhibitor , and received at least two prior lines of endocrine therapy and recurrent or metastatic setting .

Alan Auerbach: Number two, ALISCA Lung1, a Phase II trial 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 prior treatment with a CDK4/6 inhibitor, 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 alisertib at either 30, 40 or 50 milligrams twice daily, BID, on days one to three, eight to 10, and 15 to 17 on a 28-day cycle, in combination with the endocrine therapy of the investigator's choice.

Speaker #1: To be eligible for the trial , patients are being dosed with Alisertib at either 30 , 40 , or 50mg twice daily . Bid on days 1 to 3 , 8 to 10 , and 15 to 17 , and a 28 day cycle in combination with endocrine therapy .

Speaker #1: 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.

Alan Auerbach: 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. The primary endpoint for the trial includes 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 activity, as has been seen in preclinical and clinical studies in other cancers, including breast and small cell lung cancer. Depending on the outcome of the data, the company will then look to focus the future clinical development of alisertib in combination with endocrine therapy for patients with HER2-negative, hormone receptor-positive breast cancer in these biomarker-specific patient population or in the broader population of interest. The trial was initiated in late November 2024.

Speaker #1: In the trial . The primary end point for the trial includes injective response rates , duration of response , disease control rate , and progression free survival .

Speaker #1: As a secondary objective , the company will be evaluating each of these efficacy endpoints with a biomarker subgroups in order to determine whether any biomarker subgroup correlates with better activity .

Speaker #1: As has been seen in preclinical and clinical studies and other cancers , including breast and small cell lung cancer . Depending on the outcome of the data , the company will then look to focus the future clinical development of alisertib in combination with endocrine therapy for patients with Her2 negative hormone receptor positive breast cancer .

Speaker #1: In these biomarker specific patient populations or in the broader population of interest , the trial was initiated in late November 2024 . There are currently 35 sites in the US and 18 sites in Europe that have been activated for the trial , and the trial is enrolling ahead of expectations .

Alan Auerbach: There are currently 35 sites in the US and 18 sites in Europe that have been activated for the trial, and the trial is enrolling ahead of expectations. The trial was originally designed to enroll 150 patients and was originally anticipated to achieve full enrollment in December 2026. As we have previously reported, enrollment in the trial has occurred faster than expected, and we therefore reached 150 patients enrolled in February 2026. There are currently 164 patients enrolled in the trial and 15 additional patients in screening. Screening in the study is now closed. We anticipate that the interim data from this trial will be available in Q2 of 2026.

Speaker #1: The trial was originally designed to enroll 150 patients , and was originally anticipated to achieve full enrollment in December 2026 . As we have previously reported , enrollment in the trial has occurred faster than expected , and we therefore reached 150 patients enrolled in February 2026 .

Speaker #1: There are currently 164 patients enrolled in the trial, and 15 additional patients in screening. Screening in the study is now closed.

Speaker #1: We anticipate that the interim data from this trial will be available in Q2 of 2026 , per the study protocol . The interim safety and Efficacy analysis will be done after approximately 75 patients have been randomized and have completed at least two tumor assessments , or have documented disease progression or death with respect to Alaska lung one , as investors are aware , Puma has ongoing phase two of our investigational drug Alisertib to investigate the efficacy of alisertib monotherapy in patients with small cell lung cancer and is specifically look at the efficacy of the drug in patients with biomarkers , with Aurora kinase pathway plays a role .

Alan Auerbach: Per the study protocol, the interim safety and efficacy analysis will be done after approximately 75 patients have been randomized and have completed at least two tumor assessments or have documented disease progression or death. With respect to ALISCA-Lung1, as investors are aware, Puma has ongoing Phase II of our investigational drug, alisertib, to investigate the efficacy of alisertib monotherapy in patients with small cell lung cancer, and to specifically look at the efficacy of the drug in patients with biomarkers where the Aurora kinase pathway plays a role. The goal is to correlate the efficacy in these biomarker subgroups in the ALISCA-Lung1 study to the efficacy that was previously seen in the biomarker subgroups from the randomized trial of paclitaxel plus alisertib versus paclitaxel plus placebo that was published in the Journal of Thoracic Oncology in 2020.

Speaker #1: The goal is to correlate the efficacy in these biomarker subgroups in the lung. One study to the efficacy that was previously seen in the biomarker subgroups from the randomized trial of paclitaxel plus alisertib versus paclitaxel plus placebo that was published in the Journal of Thoracic Oncology in 2020.

Speaker #1: In that randomized trial , a progression free survival benefit and overall survival benefit was seen in patients with biomarkers that correlate with Aurora kinase pathway .

Alan Auerbach: In that randomized trial, a progression-free survival benefit and overall survival benefit was seen in patients with biomarkers that correlate with Aurora kinase pathway. If the efficacy and biomarker data are comparable from the 2 studies, the company would look to engage the FDA to discuss the regulatory path further. As discussed on the recent earnings call, the company believes that the data obtained to date in the ALISCA Lung 1 study is providing a preliminary indication that... of potentially better activity in patients with biomarkers where the Aurora kinase pathway plays a role. The most recent analysis of pharmacokinetic data from ALISCA Lung suggests that we are seeing lower PK of alisertib in the ALISCA Lung-1 trial, compared to the previous Phase II study of alisertib monotherapy in small cell lung cancer patients that was published in Lancet Oncology.

Speaker #1: If the efficacy and biomarker data are comparable from the two studies , the company would look to engage the FDA to discuss the regulatory path further , as discussed on the recent earnings call , the company believes that the data obtained to date in the Eliska one study is providing a preliminary indication of potentially better activity in patients with biomarkers with Aurora kinase pathway plays a role .

Speaker #1: The most recent analysis of pharmacokinetic data from Eliska Lung suggests that we are seeing lower PK of alisertib in the lung . One trial compared to the previous phase two study of Alisertib monotherapy in small cell lung cancer patients .

Speaker #1: That was published in Lancet Oncology. The company amended the protocol for the trial to increase the dose of alisertib from 50 mg BID to 60 mg BID, which the company believes will increase the PK of the drug to levels closer to what was seen in the prior phase two.

Alan Auerbach: The company amended the protocol for the trial to increase the dose of alisertib from 50 mg BID to 60 mg BID, which the company believes will increase the PK of the drug to levels closer to what was seen in the prior Phase II. The company is currently enrolling patients at the 60 mg dose. There are currently 79 patients enrolled in the trial, with 27 of these enrolled at the 60 mg BID dose, and an additional three patients in screening. Based on a preliminary review of the data from the 60 mg cohort, the company believes that the safety of the 60 mg dose is acceptable, and the company is in the process of submitting a protocol amendment to the FDA to increase the dose to 70 mg in the trial.

Speaker #1: The company is currently enrolling patients at the 60mg dose . There are currently 79 patients enrolled in the trial , with 27 of these enrolled at the 60mg bid dose .

Speaker #1: An additional three patients in screening based on a preliminary review of the data from the 60mg cohort , the company believes that the safety of the 60mg dose is acceptable , and the company is in the process of submitting a protocol amendment to the FDA to increase the dose to 70mg on the trial .

Speaker #1: Separately , Puma also plans to initiate a second trial of assertive in small cell lung cancer , where the drug will be given in combination with paclitaxel , similar to the previously mentioned trial that was published in the Journal of Thoracic Oncology .

Alan Auerbach: Separately, Puma also plans to initiate a second trial of alisertib in small cell lung cancer, where the drug will be given in combination with paclitaxel, similar to the previously mentioned trial that was published in the Journal of Thoracic Oncology. 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 the ALISCA-Lung1 study in Q2 2026. As per the trial protocol, this interim analysis will include safety and efficacy data for approximately 60 patients that have been enrolled in the trial and have completed at least two tumor assessments or have documented disease progression or death.

Speaker #1: 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 the lung .

Speaker #1: One study in the second quarter of 2026, as per the trial protocol, this interim analysis will include safety and efficacy data from approximately 60 patients that have been enrolled in the trial and have completed at least two tumor assessments, or have documented disease progression or death.

Speaker #1: 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 the company's existing R&D , regulatory and commercial infrastructure .

Alan Auerbach: 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 the company'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 Storm will follow with a review of our commercial performance during the quarter.

Speaker #1: 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 .

Speaker #1: Roger Storm will follow with a review of our commercial performance during the quarter . Thanks , Alan . I appreciate the opportunity to share some additional insights into our marketing strategy .

Heather Blaber: Thanks, Alan. I appreciate the opportunity to share some additional insights into our marketing strategy. The marketing team is focused on creating 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 better understand and validate the most effective ways to communicate this 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.

Speaker #1: The marketing team is focused on creating awareness of both clinical data for Neuralink's as well as reinforcing the continued unmet need and Her2 positive early stage breast cancer .

Speaker #1: After adjuvant therapy , we continue to invest in market research to help us better understand and validate the most effective ways to communicate this data with healthcare professionals through both personal and non-personal promotion .

Speaker #1: Our strategy is focused on increasing awareness of our dual indication and Her2 positive breast cancer . We believe Neuralink's plays an important role in the early stage by reducing the risk of recurrence and in the metastatic setting by helping protect against progression .

Speaker #1: Not only do physicians who have experience with Neuralink's continue to identify appropriate patients , but we continue to adopt new prescribers year over year who recognize the unmet need and how Neuralink's can help their patients .

Heather Blaber: Not only do physicians who have experience with NERLYNX continue to identify appropriate patients, but we continue to adopt new prescribers year-over-year who recognize the unmet need and how NERLYNX can help their patients. In summary, we are excited about the potential to engage with more oncologists and support their patients diagnosed with HER2-positive breast cancer. I will now turn the call over to Roger Storms to provide an overview on the commercial performance for Q4.

Speaker #1: In summary , we are excited about the potential to engage with more oncologists and support their patients diagnosed with Her2 positive breast cancer .

Speaker #1: I will now turn the call over to Roger Storms to provide an overview on the commercial performance for the fourth quarter.

Speaker #2: Thank you . Heather , and thanks to everyone for joining our fourth quarter earnings call Before I move into the commercial review , just a reminder that I'll be making forward looking statements .

Roger Storms: Thank you, Heather, and thanks to everyone for joining our Q4 earnings call. Before I move into the commercial review, just a reminder that I'll be making forward-looking statements. The sales team remains focused on expanding overall HCP reach and frequency, with a strong emphasis on driving engagements when treatment decisions are being made. Q4 2025 call activity increased 23% year-over-year and decreased 13% quarter-over-quarter. The year-over-year increase is a direct result of continued emphasis put on executional excellence and increased field accountability, the quarter-over-quarter decrease was due to increased number of vacant territories as well as fewer opportunities with HCPs due to the holidays in Q4. I expect call activity to continue to improve as we fill vacancies. The commercial team continues to prioritize increasing use of NERLYNX, with a main focus on patients at higher risk of recurrence.

Speaker #2: The sales team remains focused on expanding overall HCP reach and frequency , with a strong emphasis on driving engagements when treatment decisions are being made .

Speaker #2: Q4 2025 Call activity increased 23% year over year and decreased 13% quarter over quarter . Year over year increase is a direct result of continued emphasis put on Executional excellence and increased field accountability .

Speaker #2: In the quarter over quarter decrease was due to increased number of vacant territories , as well as fewer opportunities with HCP due to the holidays in Q4 , I expect call activity to continue to improve as we fill vacancies .

Speaker #2: The commercial team continues to prioritize increasing use of Neuralink's , with a main focus on patients at higher risk of recurrence . There are also dedicated to enhancing clinical education and engaging through non-personal promotional efforts , as well as utilizing patient resources to support persistence and compliance .

Roger Storms: They are also dedicated to enhancing clinical education and engaging 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'll 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 Q4 2025, about 63% of our business was purchased through the SP channel, and the remaining 37% was purchased through the SD channel. We continue to see stronger growth in the SD channel, driven by two main factors. One, increased sales in the group purchasing organizations, or GPO, segment, and two, increasing 340B purchasing.

Speaker #2: During neuralink's therapy . Let me now transition to some of the commercial slides where I'll provide some specifics around performance . Slide three is an illustration of our distribution model , which is broken out into the specialty pharmacy channel .

Speaker #2: And the specialty distributor or in-office dispensing channel . In regards to the overall distribution of our business in Q4 2025 , about 63% of our business was purchased through the ESP channel , and the remaining 37% was purchased through the SD channel .

Speaker #2: We continue to see stronger growth in the SD channel, driven by two main factors: one, increased sales in the group purchasing organizations, or GPO segment, and two, increasing purchasing. Turning to slide four, Neuralink's...

Roger Storms: Turning to slide four, NERLYNX net product revenue in Q4 2025 was $59.9 million, which represents an increase of $8 million from the $51.9 million we reported in Q3 2025, and an increase of $5.5 million from the $54.4 million we reported in Q4 2024. As a reminder to investors, Puma's reported NERLYNX sales include both US net sales of NERLYNX and product supply revenues of NERLYNX to Puma's ex-US partners. Please note that in Q4 2024, we reported product supply revenue to our international partners of about $840,000, versus the $4.7 million in Q4 2025. Therefore, US net sales of NERLYNX in Q4 2025 were $55.2 million versus $53.5 million in Q4 2024.

Speaker #2: Net product revenue in Q4 2025 was $59.9 million, which represents an increase of $8 million from the $51.9 million we reported in Q3 2025.

Speaker #2: An increase of $5.5 million from the $54.4 million we reported in Q4 of 2024. As a reminder to investors, Puma's reported Nerlynx sales include both US net sales of Nerlynx and product supply revenues of Nerlynx to Puma's ex-US partners.

Speaker #2: Please note that in Q4 2024 , we reported product supply revenue to our international partners of about 840,000 versus the 4.7 million in Q4 of 2025 .

Speaker #2: Therefore , US net sales of Nerlynx in Q4 2025 were 55.2 million versus 53.5 million in Q4 of 2024 . I will provide some more details around inventory changes , and Maximo will provide some additional specifics around gross and net expenses during his update in Q4 2025 , we estimate that inventory increased by about 5.7 million as a comparator , we estimate that inventory increased by about 3.1 million in Q3 of 2025 , and increased by about 3.7 million in Q4 of 2024 .

Roger Storms: I will provide some more details around inventory changes, and Maximo will provide some additional specifics around gross and net expenses during his update. In Q4 2025, we estimate that inventory increased by about $5.7 million. As a comparator, we estimate that inventory increased by about $3.1 million in Q3 2025, and increased by about $3.7 million in Q4 2024. Slide 5 shows Q4 2025 ex-factory bottle sales and also provides a year-over-year and quarter-over-quarter comparison. In Q4 2025, NERLYNX ex-factory bottle sales were 3,298, which represents an approximate 12% increase quarter-over-quarter and an 11% increase year-over-year. Inventory declined for the first two quarters, but increased in Q3 2025 and Q4 2025.

Speaker #2: Slide five shows Q4 2025 Ex-factory bottle sales , and also provides a year over year and quarter over quarter comparison in Q4 2025 .

Speaker #2: Nerlynx Ex-factory bottle sales were 3298 , which represents an approximate 12% increase quarter over quarter and an 11% increase year over year . Inventory declined for the first two quarters , but decreased .

Speaker #2: But increased in Q3 of 2025 and Q4 of 2025 . Similar to the prior slide , let me specifically call out the inventory changes from a bottle perspective in Q4 2025 .

Roger Storms: Similar to the prior slide, let me specifically call out the inventory changes from a bottle perspective. In Q4 2025, we estimate the inventory increased by 343 bottles. As a comparator, we estimate the inventory increased by 182 bottles in Q3 2025, and increased by 205 bottles in Q4 2024. Let me take a moment to provide some additional metrics regarding our Q4 performance. In Q4, we saw enrollments decline by about 5% quarter-over-quarter and decline by about 3% year-over-year. New patient starts, or NRXs, followed a similar pattern, declining approximately 11% quarter-over-quarter and declining about 6% year-over-year. Turning to total prescriptions, or TRXs, we saw TRX increase about 2% quarter-over-quarter and decline about 6% year-over-year.

Speaker #2: We estimate that inventory increased by 343 bottles as a comparator , we estimate that inventory increased by 182 bottles in Q3 of 2025 , and increased by 205 bottles in Q4 of 2024 .

Speaker #2: Let me take a moment to provide some additional metrics regarding our fourth quarter performance in Q4 . We saw enrollments decline by about 5% quarter over quarter , and declined by about 3% year over year .

Speaker #2: New patient starts were nrxrx , followed a similar pattern , declining approximately 11% quarter over quarter and declining about 6% year over year .

Speaker #2: Turning to total prescriptions or trqs , we saw TRX increase about 2% quarter over quarter and decline about 6% year over year . Finally , let me share some specifics around demand in Q4 2025 , we saw demand increase by about 7% quarter over quarter .

Roger Storms: Finally, let me share some specifics around demand. In Q4 2025, we saw demand increase by about 7% quarter-over-quarter and about 7% year-over-year. As mentioned earlier, we have seen stronger demand growth in the SD channel, where we saw SD grow by about 17% quarter-over-quarter and about 46% year-over-year. Slide 6 highlights the quarterly adoption of dose escalation since the launch of NERLYNX. In Q4 2025, approximately 75% of patients started NERLYNX at a reduced dose. This is lower compared to the 77% we reported in Q3 2025. Continued messaging and adoption of dose escalation remains an important commercial priority. Patients who start on NERLYNX utilizing dose escalation have better persistence and compliance.

Speaker #2: And about 7% year over year. As mentioned earlier, we have seen stronger demand growth in the SD channel, where we saw SD grow by about 17% quarter over quarter and about 46% year over year. Slide six highlights the quarterly adoption of dose escalation since the launch of Neuralink's in Q4 2025.

Speaker #2: Approximately 75% of patients started Neuralink's at a reduced dose. This is lower compared to the 77% we reported in Q3 of 2025. Continued messaging and adoption of dose escalation remains an important commercial priority.

Speaker #2: Patients who start on nerlynx utilizing dose escalation have better persistence and compliance . 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 .

Roger Storms: 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 seven highlights the strategic collaborations we have formed across the globe. In Q4 of 2025, NERLYNX was launched in Algeria in the extended adjuvant setting. Most recently, in Q1 of 2026, 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'll close by sharing my sincere appreciation for the entire Puma team and their steadfast commitment to supporting patients and families affected by breast cancer. This disease is truly devastating, and while meaningful progress has been made, we know there is still important work ahead and even more we can accomplish together.

Speaker #2: Slide seven highlights the strategic collaboration we have formed across the globe in Q4 of 2025 . Nerlynx was launched in Algeria and the extended adjuvant setting most recently in Q1 of 2026 .

Speaker #2: 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 .

Speaker #2: Moving forward . I'll close by sharing my sincere appreciation for the entire Puma team and their steadfast commitment to supporting patients and families affected by breast cancer .

Speaker #2: This disease is truly devastating, and while meaningful progress has been made, we know there is still important work ahead and even more we can accomplish together.

Speaker #2: I will now turn the call over to Maximo for a review of our financial results.

Roger Storms: I will now turn the call over to Maximo for a review of our financial results.

Speaker #3: Thanks , Roger . I will begin with a brief summary of our financial results for the fourth quarter of 2025 . Please note that I will make comparisons to Q3 2025 , which we believe is a better indication of our progress as a commercial company than year over year comparisons .

Maximo Nougues: Thanks, Roger. I will begin with a brief summary of our financial results for Q4 2025. Please note that I will make comparisons to Q3 2025, 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 2025 10-K, which will be filed today and includes our consolidated financial statements. For Q4 2025, we reported net income based on GAAP of $13.4 million, or $0.20 per share, basic share, and $0.26 per diluted share. This compares to net income in Q3 2025 of $8.8 million, or $0.18 per basic share, and $0.17 per diluted share.

Speaker #3: For more information , I recommend that you refer to our 2025 10-K , which will be filed today and includes our consolidated financial statements for the fourth quarter of 2025 .

Speaker #3: We reported net income based on GAAP of 13.4 million , or $0.20 per share , basic share , and $0.26 per diluted share .

Speaker #3: This compares to net income in Q3 2025 of $8.8 million, or $0.18 per basic share and $0.17 per diluted share. The fourth quarter of 2025 included a net change in valuation allowance that unfavorably impacted net income by $3.2 million.

Maximo Nougues: The Q4 2025 included a net change in valuation allowance that unfavorably impacted net income by $3.2 million. On a non-GAAP basis, which is adjusted to remove the impact of stock-based compensation expense, we reported net income of $15.1 million, or $0.30 per basic share, and $0.29 per diluted share for the Q4 2025. Gross revenue from NERLYNX sales was $82.9 million in Q4 2025, and $70 million in Q3 2025.

Speaker #3: On a non-GAAP basis , which is adjusted to remove the impact of stock based compensation expense . We reported net income of 15.1 million , or $0.30 per basic share , and $0.29 per diluted share for the fourth quarter of 2025 .

Speaker #3: Gross revenue from Nerlynx sales was 82.9 million . In Q4 2025 , and 70 million in Q3 2025 . As Alan mentioned , net product revenue from Nerlynx sales was 59.9 million , an increase from the 51.9 million reported in Q3 2025 and an increase versus the 54.4 million reported in Q4 2020 .

Maximo Nougues: As Alan mentioned, net product revenue from NERLYNX sales was $59.9 million, an increase from the $51.9 million reported in Q3 2025, and an increase versus the $54.4 million reported in Q4 2024. 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-US partners. Please note that in Q4 2025, we reported product supply revenue to our international partners of about $4.7 million. Therefore, US net sales of NERLYNX in Q4 2025 were $55.2 million versus $51.8 million in Q3 2025. The increase in Q4 2025 net revenue versus Q3 2025 was driven primarily by an increase in NERLYNX demand, an inventory build of $5.7 million, offset by higher gross net expense.

Speaker #3: For . 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 US partners .

Speaker #3: Please note that in Q4 2025, we reported product supply revenue to our international partners of about $4.7 million. Therefore, US net sales of Nerlynx in Q4 2025 were $55.2 million versus $51.8 million in Q3 2025.

Speaker #3: The increase in Q4 2025 net revenue versus Q3 2025 was driven primarily by an increase in nerlynx demand and inventory build of 5.7 million , offset by higher , higher gross net expense , royalty revenue totaled 15.6 million in the fourth quarter of 2025 , compared to 2.6 million in Q3 2025 .

Maximo Nougues: Royalty revenue totaled $15.6 million in Q4 2025, compared to $2.6 million in Q3 2025. The increase in royalty was driven the shipment to our partner in China. Our gross to net adjustment in Q4 2025 was about 27.8% and 25.9% in Q3 2025. The increase on gross to net was driven mostly by higher Medicare and Medicaid share and higher government chargebacks. Cost of sales for Q4 2025 was $23.2 million, and includes $2.4 million for the amortization of intangible assets related to our neratinib license. Cost of sales for Q3 2025 was $12.2 million. Going forward, we will continue to recognize amortization of milestones to the licensor, about $2.4 million per quarter as cost of sales.

Speaker #3: The increase in royalty was driven , was driven the shipment to our partner in China , our gross to net adjustment in Q4 2025 was about 27.8% and 25.9% in Q3 2025 .

Speaker #3: The increase on gross to net was driven mostly by higher Medicare and Medicaid share and higher government chargebacks Cost of sales for Q4 2025 was 23.2 million , and includes 2.4 million for the amortization of intangible assets related to our Neratinib license .

Speaker #3: Cost of sales for Q3 2025 was 12.2 million , going forward , we will continue to recognize amortization of milestones to the licensor .

Speaker #3: About $2.4 million per quarter as cost of sales. For fiscal year 2026, Puma anticipates that net Nerlynx product revenue will be in the range of $194 to $198 million.

Maximo Nougues: For fiscal year 2026, Puma anticipates that net NERLYNX product revenue will be in the range of $194 to $198 million. We also anticipate that our gross net adjustment for the full year 2026 will be between 27.5% and 28.5%. Significantly higher than 2025, as we expect high government chargebacks on Medicare and Medicaid share to maintain in the same levels we saw in the last quarters of 2025. In addition, for fiscal year 2025, we anticipate receiving royalties from our partners around the world in the range of $20 to $23 million. We don't expect any license revenue in 2025. We also expect that net income for the full year will be in the range of $10 to $13 million.

Speaker #3: We also anticipate that our gross-to-net adjustment for the full year 2026 will be between 27.5% and 28.5%, significantly higher than 2025.

Speaker #3: As we expect higher government chargebacks and Medicare and Medicaid share to maintain in the same levels we saw in the last quarter of 2025 .

Speaker #3: In addition , for fiscal year 2025 , we anticipate receiving royalties from our partners around the world in the range of 20 to 23 million .

Speaker #3: We don't expect any license revenue in 2025 . We also expect that net income for the full year will be in the range of 10 to 13 million .

Speaker #3: 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 adjustments will be required or , if so , the potential timing or size of such an adjustment .

Maximo Nougues: 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 adjustments will be required, or if so, the potential timing or size of such an adjustment. We will continue to keep investors updated 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, would have a material impact on our product cost or results of operations. However, shifts in trade policies in the United States and other countries have been rapidly evolving and are difficult to predict.

Speaker #3: We will continue to keep investors updated as this , as it progresses . At this time , we do not believe that tariffs impose or proposed to be imposed by the United States , particularly with other countries , will have a material impact on our product cost and other product costs or results of operations .

Speaker #3: However , shift and 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 accounts for a mid to high single digit percentage of our total cost of goods sold .

Maximo Nougues: As a point of reference, our manufacturing product costs account for a mid to high single digits percentage of our total cost of goods sold. We anticipate that for Q1 2026, NERLYNX product revenue net will be in the range of $36 to 39 million. Please note that the Q1 net product revenue is usually the lowest quarter of the year, as we often see inventory burn off from our distribution channel. We expect Q1 royalty revenue will be in the range of $2 to 3 million and no license revenue. We further estimate that the gross to net adjustment in Q1 2026 will be approximately 29.5% to 30.5%. Puma anticipates a Q1 net loss between $8 million and 10 million.

Speaker #3: We anticipate that for Q1 2026 , Nerlynx product revenue , net will be in the range of 36 to 39 million . Please note that the Q1 net product revenue is usually the lowest quarter of the year .

Speaker #3: As we often see inventory burn off from our distribution channel, we expect Q1 royalty revenue will be in the range of $2 million to $3 million, and no license revenue, with further estimate that the gross-to-net adjustment in Q1 2026 will be approximately 29.5% to 30.5%.

Speaker #3: Puma anticipates a Q1 net loss of 8 million between , sorry , between 8 million and 10 million . As G&A expenses were 18.4 million in the fourth quarter of 2025 , 16.8 million in the third quarter .

Maximo Nougues: SG&A expenses were $18.4 million in Q4 of 2025, compared to $16.8 million in Q3. SG&A expenses included non-cash charges for stock-based compensation of $1 million for Q4 and $1.1 million for Q3 2025. Research and development expenses were $16.8 million in Q4 of 2025, and $15.9 million in Q3. R&D expenses included non-cash charges for stock-based compensation of $0.7 million in Q4 of 2025, unchanged from Q3. On the expense side, Puma anticipates higher than operating expenses in 2026 compared to 2025. More specifically, we anticipate SG&A expenses to increase by 3% to 5%, and R&D expenses to increase by 30% to 35% year-over-year.

Speaker #3: As G&A expenses included non-cash charges for stock based compensation of 1 million for Q4 and 1.1 million for Q3 2025 . Research and development expenses were 16.8 million in the fourth quarter of 2025 , and 15.9 million in the third quarter .

Speaker #3: R&D expenses included non-cash charges for stock based compensation of 0.7 million in the fourth quarter of 2025 , unchanged from the third quarter .

Speaker #3: On the expense side , Puma anticipates higher than the operating expenses in 2026 compared to 2025 . More specifically , we anticipate SG&A expenses to increase by 3 to 5% and R&D expenses to increase by 30 to 35% year over year .

Speaker #3: The increase , the higher increase in R&D is driven by the progress of our clinical trials in the fourth quarter of 2025 , Puma reported .

Maximo Nougues: The higher increase in R&D is driven by the progress of our clinical trials. In Q4 of 2025, Puma reported cash earned of approximately $3.1 million. This compares to cash burn of approximately $1.6 million in Q3. Please note that during Q4, we made our 7th quarterly principal loan payment of $11.1 million related to our obligation with Athyrium. As a result of this, our total outstanding principal debt balance decreased to approximately $22 million. On 31 December 2025, we had approximately $97.5 million in cash equivalents, and marketable securities, versus about $101 million at year-end in 2024. Our accounts receivables balance was $53.7 million. Our accounts receivable terms range between 10 and 68 days, while our day sales outstandings are about 48 days.

Speaker #3: Cash earned of approximately $3.1 million. This compares to cash burn of approximately $1.6 million in the prior quarter. Please note that during Q4, we made our seventh quarterly principal loan payment of $11.1 million related to our obligation with Ethereum. As a result of this, our total outstanding principal debt balance decreased to approximately $22 million at December 31, 2025.

Speaker #3: We had approximately $97.5 million in cash, cash equivalents, and marketable securities, versus about $101 million at year end in 2024. Our accounts receivable balance was $53.7 million.

Speaker #3: Our accounts receivable terms ranged between 10 and 68 days , while our sales outstanding are about 48 days . We estimate that as of December 31st , 2025 , our distribution network maintained approximately 4.5 weeks of inventory .

Maximo Nougues: We estimate that as of 31 December 2025, our distribution network maintained approximately 4.5 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.

Speaker #3: Overall , we continue to deploy our financial resources to focus on the commercialization of Nerlynx . The development of Alisertib , and controlling our expenses .

Speaker #1: Thanks , Maximo Nougues .

Alan Auerbach: Thanks, Maximo. On past earnings calls, we have stressed that Puma's 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 are pleased to achieve positive net income for the full year 2025, which marks the third consecutive year of profitability for the company. We believe that the positive net income that the company is guiding to for the full year 2026 is resulting from 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.

Speaker #2: On past earnings .

Speaker #1: Calls , we have stressed that Puma's senior management and 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 .

Speaker #1: We are pleased to achieve positive net income for the full year 2025 , which marks the third consecutive year of profitability for the company .

Speaker #1: We believe that the positive net income that the company is guiding to for the full year 2026 is resulting from 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 .

Speaker #1: 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 .

Alan Auerbach: 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. We will continue to strive to achieve that goal. This concludes today's presentation. We will now turn the call back to the operator for Q&A.

Speaker #1: We had Puma , our 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 .

Speaker #1: This concludes today's presentation. We will now turn the call back to the operator for Q&A.

Speaker #4: Thank you . If you would like to ask a question , please press star one on your telephone keypad . A confirmation tone will indicate your line is in the question queue .

Operator: Thank you. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing your star keys. Our first question is from Salvatore Caruso with TD Cowen. Please proceed.

Speaker #4: You may press star two if you would like to remove your question from the queue . And for a participant using speaker equipment , it may be necessary to pick up your handset before pressing your star keys Our first question is from Salvatore Caruso with TD Cowan .

Speaker #4: Please proceed .

Speaker #5: Hi , this is Salvatore Caruso on behalf of Marc from over at TD Cowan . Great Just one quick question . Can you maybe speak to some of the dynamics around the inventory , build this fourth quarter , as well as how it relates to build previous quarters ?

Salvatore Caruso: Hi, this is Salvatore Caruso on behalf of Marc Frahm over at TD Cowen. Great presentation. Just one quick question. Can you maybe speak to some of the dynamics around the inventory build this Q4, as well as how it relates to build previous quarters? Is there any sort of overall trend that you're starting to see, and kind of what can we expect going forward? Thank you.

Speaker #5: Is there any sort of overall trend that you're starting to see and kind of what can we expect going forward ? Thank you

Alan Auerbach: Salvatore, this is Alan. We tend to always see an inventory build at the end of the quarter, at the end of the year, especially in Q4. This has been since launch. A lot of the reason for that is that, you know, there's an assumption that you're gonna take a price increase at the beginning of the year. We perceive the reason they're doing that is to get in on that, you know, to buy before you do the price increase. Maximo, if you wanna speak to, you know, a little more of the logistics there?

Speaker #1: So , Salvatore , this is Alan . We tend to always see an inventory build at the end of the quarter . At the end of the year , especially in the fourth quarter .

Speaker #1: This has been since launch . A lot of the reason for that is that , you know , there's an assumption that you're going to take a price increase beginning of the year .

Maximo Nougues: Yes, Salvatore.

Q4 2025 Puma Biotechnology Inc Earnings Call

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