Q1 2025 Puma Biotechnology Inc Earnings Call
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Operator: If you should require operator assistance during the conference, please press star 0. As a reminder, this call is being recorded.
Speaker Change: Sure 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 Marianne Harrison Senior director of Investor Relations for Puma Biotechnology. Thank you you may begin your conference.
Mariann Ohanesian: I would now like to turn the conference over to Mariann Ohanesian, Senior Director of Investor Relations for Puma Biotechnology. Thank you. You may begin your conversation. Thank you, Sherry.
Sheri: Thank you Sheri good.
Mariann Ohanesian: Good afternoon and welcome to Puma's conference call to discuss our earnings results for the first quarter of 2025. 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 That news release, the slides that Jeff will refer to, and a webcast of this call are accessible via the homepage and investor sections of our website at Pumabiotechnology.com.
Marianne Harrison: Afternoon, and welcome to <unk> conference call to discuss our earnings results for the first quarter of 2025, joining me on the call today are Alan Auerbach, Chief Executive Officer, President and Chairman of the board of Puma Biotechnology, Max ammonia gas Chief Financial Officer, Jeff Ludwig Chief Commercial Officer.
Speaker Change: They're blaber, vice president of marketing and Jeff's storms, Vice president of sales.
Speaker Change: After the close today Puma issued a news release detailing earnings result for first quarter of 2025.
Speaker Change: That news release, the slides that Jeff will referred to and a webcast of this call are accessible via the home page and investor sections of our website at Puma Biotechnology Dot com on the webcast and presentation slides will be archived on our website and available for replay for the next 90 days.
Mariann Ohanesian: 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. Such statements are subject to risks and uncertainties, and actual events and results may differ from those expressed in these forward-looking statements.
Speaker Change: Today's conference call will include statements about <unk> future expectations plans and prospects that constitute forward looking statements for purposes of federal Securities laws.
Speaker Change: Such statements are subject to risks and uncertainties and actual events and results may differ from those expressed in these forward looking statements.
Mariann Ohanesian: for a full discussion of these risks and incentives.
Speaker Change: For a full.
Speaker Change: Full discussion of these risks and uncertainties. Please review our periodic and current reports filed with the SEC from time to time, including our annual report on Form 10-K for the USD 31 2024.
Mariann Ohanesian: Please review our periodic and current reports filed with the SEC from time to time, including our annual report on Form 10-K for the years December 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, May 8, 2025. Puma undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this recording.
Speaker Change: 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 May eight 2025.
Speaker Change: I'm Gonna 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.
Mariann Ohanesian: Accept 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.
Speaker Change: During today's call, we may refer to certain non-GAAP financial measures that involve adjustments to 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: please refer to our first quarter 2025 earnings release for a reconciliation of our GAAP to non-GAAP results.
Speaker Change: Please refer to our first quarter 2025 earnings release for a reconciliation of our GAAP to non-GAAP results I will now turn the call over to Alan.
Alan Auerbach: I will now turn the call over to Alan. Thank you, Mariann, and thank you all for joining our call today. Today, Puma reported total revenue for the first quarter of 2025 of $46.0 million. Total revenue includes product revenue net, which consists entirely of Neuralink sales, as well as royalties from our sub-licensing. Product revenue net was $43.1 million in the first quarter of 2025, a decline from the $54.4 million reported in Q4 2024, and an increase from the $40.3 million reported in Q1 of 2025. Product revenue for the first quarter of 2025 was impacted by approximately $4.7 million of inventory decrease at our specialty pharmacies and specialty distributors.
Alan: Thank you Mary Anne and thank you all for joining our call today.
Alan: Today promote reported total revenue for the first quarter of 2025, or 46 point and $1 million.
Alan: Total revenue includes product revenue nurture, which consist entirely of nearly sales as well as royalties from our sub licensees product revenue net debt was $43 1 million in the first quarter of 2025, a decline from the $54 4 million reported in Q4 of 2024 and an increase from.
Alan: The $40 3 million reported in Q1 of 2024.
Alan: Product revenue for the first quarter of 2025 was impacted by approximately $4 $7 million of inventory decrease at our specialty pharmacies and specialty distributors.
Alan Auerbach: Royalty revenue was $2.9 million in the first quarter of 2025, compared to $4.7 million in Q4 2024, and $3.5 million in Q1 2025. We reported 2,338 bottles of Nearlings, sold in the first quarter of 2025. decrease of 626 from the 2,964 bottles sold in Q4 2021. In Q125, we estimate that inventory decreased by 251 bottles. In Q1 2025, new prescriptions, or NRX, were up approximately 6% compared to Q4 2024, and total prescriptions were down approximately 9% compared to Q4 2024.
Alan: Royalty revenue was $2 9 million in the first quarter of 2025 compared to $4 7 million in Q4, 2024, and $3 5 million in Q1 2024.
Alan: We reported 2000 and 338 bottles up nearly <unk> sold in the first quarter of 2025.
Alan: A decrease of 626 from the 2964 bottles sold in Q4 2024.
Alan: In Q1, 25, we estimate that inventory decreased by 251 box in Q1, 2025, new prescriptions or interacts were up approximately 6% compared to Q4 2024 and totals for prescriptions were down approximately 9% compared to Q4 2024.
Alan Auerbach: Jop will provide further details in his comments and slides.
Jeff: Jeff will provide further details in his comments and slides.
Alan Auerbach: 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 Nearling's commercial activities.
Speaker Change: 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 the earliest commercial activities.
Alan Auerbach: Maximo Nougues will follow with highlights of the key components of our financial statements for the first quarter of 2025.
Speaker Change: Maximo <unk> will follow with highlights of the key components of our financial statements for the first quarter of 2025.
Alan Auerbach: At the recent American Association for Cancer Research, or AACR, annual meeting, interim data from an ongoing Phase 1 trial, which is NCT 05372, that is sponsored by the National Cancer Institute, evaluating the combination of duratinib and famtrastuzumab durextacan orinhertu in patients with metastatic solid tumors was presented. The Phase 1 data includes patients with metastatic solid tumors harboring HER2 overexpression, IHC 3+. HerB2 amplifications are activating HER2 mutations. In the poster presentation, 20 patients received study treatments. Dose level 1 had 7 patients, dose level 2 had 4 patients, dose level 3 had 9 patients. The most common treatment emergent adverse events of any grade included nausea, N equals 15 or 75 percent, diarrhea, N equals 15 or 75 percent, fatigue, N equals 13 or 65 percent, and hypokalemia, N equals 11 or 55 percent.
Speaker Change: The recent American Association for cancer research or ACR annual meeting interim data from an ongoing phase one trial, which is N. C. T 053 hundred 72 that are sponsored by the National Cancer Institute evaluating the combination of the rat Nib and famine Trastuzumab <unk> arent hurt you in patient.
Speaker Change: With metastatic solid tumors was presented the phase one data includes patients with metastatic solid tumors harboring hurts you over expression I see three plus <unk>.
Speaker Change: <unk> amplifications or activating hurts you mutations in the poster presentation 20 presentation 20 patients received study treatment dose level, one had seven patients at dose level two had four patients at dose level three had nine patients.
Speaker Change: The most common treatment emergent adverse events of any grade included nausea, and equals 15, or 75 per cent diarrhea, and equals 15 or 75%.
Speaker Change: G N equals 13, or 65% and hyperkalemia N equals 11 or 55%.
Alan Auerbach: grade 3 treatment emergent adverse events that occurred in more than two patients included anemia, N equals 6 or 30 percent, diarrhea, N equals 4 or 20 percent, and hypokalemia, N equals 3 or 15 percent. The only grade four treatment-related adverse event was neutropenia that occurred in one patient, which was 5%. 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 1 pneumonitis or interstitial lung disease, ILD.
Speaker Change: <unk> three treatment emergent adverse events that occurred in more than two patients included anemia, N equals six or 30% diarrhea, and equals four or 20% and hyperkalemia and equals three or 15%.
Speaker Change: The only grade four treatment related adverse events with neutropenia that incurred one patients which was 5% one.
Speaker Change: One D L T, which was acute kidney injury was observed at dose level. One no deal cheese were observed at dose level, two and one DLT was observed which was fatigue, leading to early discontinuation at dose level three.
Speaker Change: Three patients developed great, one pneumonitis or interstitial lung disease or ILD.
Alan Auerbach: Two patients at dose level one and one at dose level. 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 2, and it was one HER2 positive IHC3 plus, and one HER2 mutated. Pancreatic, which was one patient who was an IHC3 plus, and ovarian, which was one patient who was also a 3 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.
Speaker Change: Two patients at dose level, one and one at dose level three.
Speaker Change: The proportion of reported treatment emergent adverse events was lower at higher doses.
Speaker Change: Although his teen response evaluable patients by resist four patients had a partial response, including patients with gastroesophageal I wish it was equal to and I was one hurts you positive IAC threep plus in one or two mutated.
Speaker Change: Pancreatic which was one patient who was an IHA three plus in ovarian.
Speaker Change: There was one patient who was also a three plus in the ovarian was a confirmed response.
Speaker Change: 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% progression for eight cycles.
Alan Auerbach: Dose level 3, which consisted of trastuzumab, durextacan at 5.4 mg per kg, and neratin at about 120 mg in week 1, 160 in week 2, and 240 in week 3 and onward. was selected as the recommended phase two dose.
Speaker Change: Dose level, three which consisted of Trastuzumab direct you can't at five four and mixed per keg and they're writing about 120 Megs in week, one 160 in week, two and $2 40 in week three and onward.
Speaker Change: Selected as our recommended phase two dose part two of the study which consist of a pharmacodynamic evaluation of Trastuzumab director can wittner at nave in 12 patients open to enrollment in March of 2025.
Alan Auerbach: Part two of the study, which consists of a pharmacodynamic evaluation of trastuzumab durextacan with neratinib in 12 patients, open to enrollment in March of 2025. Patients with advanced solid tumor and HER2 amplification or overexpression or a HER2 mutation will be enrolled. We look forward to updated data from this trial to be presented likely in 2026.
Speaker Change: Patients with advanced solid tumor and hurt you amplification or overexpression or hurts you mutation will be enrolled we look forward to updated data from the trial to be presented are likely in 2026.
Alan Auerbach: In addition, Puma currently has two ongoing Phase II studies of our investigational drug alisertib, the ELISCA Breast I trial, which is a Phase II trial of alisertib in combination with endocrine treatment in patients with HER2 negative, hormone receptor positive, metastatic breast cancer, and ELISCA Lung I, which is a Phase II study looking at the efficacy of alisertib monotherapy in patients with small cell lung cancer. As a reminder, the ELISCA Breast 1 trial investigates alicertib in combination with endocrine treatment. consists of either anastrozole, examestane, letrozole, fulvestrant, or tamoxifen in patients with HER2 negative, hormone receptor positive metastatic breast cancer.
Speaker Change: In addition, Puma currently has two ongoing phase III studies of our investigational drug al asserted the Eliska breast one trial, which is a phase two trial Val asserted in combination with endocrine treatment in patients with her two negative hormone receptor positive metastatic breast cancer and a litho lung one which is a phase two study looking at the efficacy.
Speaker Change: A L asserted mono therapy in patients with small cell lung cancer.
Speaker Change: As a reminder, the Elisa breast one trial investigating <unk> in combination with endocrine treatment with.
Speaker Change: Which consists of either anastrozole, exemestane, let yourself or investments or tamoxifen in patients with her two negative hormone receptor positive metastatic breast cancer patients.
Alan Auerbach: Patients must be chemotherapy naive, have been previously treated with CDK4-6 inhibitors, and received at least two prior lines of endocrine therapy. or metastatic setting to be eligible for the trial. Patients are being dosed with Alisertib, given at either 30 mg, 40 mg, or 50 mg twice daily, BID, on days 1 to 3, 8 to 10, and 15 to 17, on a 28 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 L-Ascerdib in the trial.
Patients must be chemotherapy naive had been previously treated with CDK four six inhibitors and received at least two prior lines of endocrine therapy, and the recurrent or metastatic setting to be eligible for the trial.
Speaker Change: <unk> are being dosed with al sort of given that either 30 negative 40, megs or 50, Megs twice daily PID on days, one to three eight to 10 and 15 to 17 and a 28 day cycle in combination with endocrine therapy of the investigator's choice.
Speaker Change: Patients must not have been previously treated with the <unk> treatment in the metastatic setting that is being given in combination with <unk> in the trial.
Alan Auerbach: Primary efficacy endpoints will include objective response rate, duration of response, disease control rate, and progression feed 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 L-Assertive in combination with Endocrine for patients with HER2 negative hormone receptor positive breast cancer in patients with E-Biomar.
Speaker Change: Primary efficacy endpoints will include objective response rate duration of response disease control rate and progression free survival.
Speaker Change: As a secondary objective the company will be evaluating each of these efficacy endpoints within biomarker subgroups.
Speaker Change: To determine whether any biomarker subgroup correlates with better efficacy as has been seen in the preclinical and clinical studies and other cancers, including breast cancer and small cell lung cancer.
Speaker Change: The company will then look to focus the future clinical development of all sort of in combination with endocrine for patients with her two negative former receptor positive breast cancer and patients with your Biomarkers.
Alan Auerbach: The trial was initiated in late November 2024. 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.
But the trial was initiated in late November 2024. 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 what expected to be enrolled this week in six additional patients in screening.
Alan Auerbach: We are looking to have interim data from this trial later in 2025.
We are looking to have interim data from this trial later in 2025.
Alan Auerbach: With respect to the ALISCA Lung Study As discussed on the last conference call, the company believes that the data obtained to date from the ELISCA Lung 1 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 ALISCA Lung 1 trial suggests that we are seeing a lower PK of aliceratib in the ALISCA Lung trial compared to the previous Phase 2 study of aliceratib monotherapy in small cell lung cancer patients that was published in the Lancet Oncology.
Speaker Change: With respect to the Alaska lung study.
Speaker Change: As discussed on the last conference call. The company believes the data obtained to date from the Eliska lung one trial is providing a preliminary indication of potentially better activity in patients with biomarkers for the Aurora kinase pathway plays a role the most recent analysis the pharmacokinetic data from the holistic along one trial suggests that we are seeing a lower <unk>.
Speaker Change: K a L assertive.
Speaker Change: Oh, let's go lung trial compared to the previous phase two study of al asserted mono therapy in small cell lung cancer patients that was published in lancet oncology. The company is in the process of amending the protocol to increase the dose of allo sorted from 50, Megs to 60, Megs, which the company believes will increase the PK of the drug to lever.
Alan Auerbach: The company is in the process of amending the protocol to increase the dose of alisertib from 50 mg to 60 mg, which the company believes will increase the PK of the drug to levels closer to what was seen in the prior phase 2 trial.
Speaker Change: Levels closer to what was seen in the prior phase two trial.
Alan Auerbach: The company looks to have additional interim data from this trial later in 2025.
Speaker Change: The company looks to have additional interim data from this trial later in 2020.
Alan Auerbach: As mentioned on prior earnings calls and in response to investor questions, Puma continues to evaluate several drugs, potentially in-license or acquire, that would allow the company to diversify itself and leverage Puma's existing R&D, regulatory, and commercial infrastructure. The company will keep investors updated on this as it progresses.
Speaker Change: 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 is existing our R&D regulatory and commercial infrastructure. The company keep investors updated on this as it progress.
Jeffrey Ludwig: I will now turn the call over to Jeff Ludwig, Puma's Chief Commercial Officer, for a review of our commercial performance during the event. 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 neural links with a primary emphasis on patients who are at increased risk of reoccurrence. The marketing team has recently revised the core sales data 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 Neuralinks therapy.
Speaker Change: I will now turn the call over to Jeff Ludwig who must chief commercial officer for a review of our commercial performance during the quarter.
Jeff Ludwig: Thanks, Alan I appreciate it and thanks to everyone for joining our first quarter earnings call.
Jeff Ludwig: Before I move into the commercial review just a reminder, that I will be making forward looking statements.
Jeff Ludwig: The commercial team remains focused on expanding the utilization of neuro linked with a primary emphasis on patients who are at increased risk of re occurrence.
Jeff Ludwig: The marketing marketing team has recently revised the core sales eight align 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 neuro links therapy.
Jeffrey Ludwig: The 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 2025, 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 we'll add some additional details in a few moments.
Jeff Ludwig: 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.
Jeff Ludwig: 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.
Jeff Ludwig: Heather Blaber, our VP of marketing and Roger storms, our VP of sales that joined US during this call. It will add some additional details in a few moments.
Jeffrey Ludwig: 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 25, 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. in the GPO segment, and two, some increasing 340B purchasing.
Jeff Ludwig: 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 our specialty distributor or in office dispensing channel.
Jeff Ludwig: In regards to the overall distribution of our business in Q1 of 25 about 67% of our business was purchased through the S. P channel and the remaining 33% was purchased through the SD channel.
Jeff Ludwig: We are seeing some stronger growth in the SD channel driven by two main factors.
Jeff Ludwig: Number one increase sales into GPO segment and to some increasing $3 40 be purchasing.
Jeffrey Ludwig: Turning to slide four, NeurLink's net revenue in Q1 of 2025 was $43.1 million, which represents a decline of about $11.3 million from the $54.4 million we reported in Q4 of 2024, and an increase of $2.8 million from the $40.3 million we reported in Q1 of 2024. 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 2025, we estimate that inventory decreased by about 4.7 million.
Jeff Ludwig: Turning to slide four.
Jeff Ludwig: Net revenue in Q1 of 2025 was $43 1 million, which represents a decline of about $11 3 million from the 54.4 million we reported in Q4 2024.
Jeff Ludwig: And an increase of $2 8 million from the $40 3 million, we reported in Q1 of 2024.
Jeff Ludwig: The significant change in quarterly revenue was driven largely by anticipated seasonal inventory changes and higher gross to net expenses in the prior quarter.
Maximal: I will provide some more details around inventory changes and maximal will provide some additional specifics around gross to net expenses during his update.
Maximal: In Q1 of 2025, we estimate that inventory decreased by about $4 7 million.
Jeffrey Ludwig: As a comparator, we estimate that inventory increased by about 3.7 million in Q4 of 24 and decreased by about 2 million in Q1 of 24.
Maximal: As a comparator we estimate the inventory increased by about $3 7 million in Q4 of 24.
Maximal: And decreased by about $2 million in Q1 of 'twenty four.
Jeffrey Ludwig: On slide 5, slide 5 shows Q1 2025 X-Factory bottle sales and also provides a year-over-year and a quarter-over-quarter comparison. In Q1 of 2025, Neuralink's X-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. In Q1 of 2025, we estimate that inventory decreased by 251 bottles. As a comparator, we estimate the inventory increased by 204 bottles in Q4 of 2024 and decreased by 120 bottles in Q1 of 2024.
Maximal: 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.
Maximal: In Q1 of 2025, <unk> ex factory bottle sales were 2338, which represents an approximate 21% decrease quarter over quarter, and a 3% decrease year over year.
Speaker Change: It is typical for us to see inventory increase in Q4, and then subsequently decline in Q1.
Speaker Change: Similar to the prior slide let me specifically call out the inventory changes from a bottle perspective.
Speaker Change: In Q1 of 2025, we estimate the inventory decreased by 251 bottles.
Speaker Change: As a comparison as a comparator we estimate the inventory increased by 204 bottles in Q4 of 'twenty four and decreased by 120 models in Q1 of 'twenty 'twenty four.
Jeffrey Ludwig: 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 a TRX decline of about 9% quarter over quarter and a decline of about 3% year over year.
Speaker Change: 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.
Speaker Change: In Q1, we saw enrollments increased about 6% quarter over quarter, but declined about 8% year over year.
Speaker Change: We have seen some continued enrollment softness in April which we are monitoring very closely.
Speaker Change: New patient starts or interacts followed a similar pattern growing about 6% quarter over quarter, but declining about 7% year over year.
Speaker Change: Turning to total prescriptions or T. Rex we saw our T Rx decline of about 9% quarter over quarter, and a decline of about 3% year over year.
Jeffrey Ludwig: 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.
Speaker Change: Finally, let me share some specifics around demand.
Speaker Change: In Q1, we saw demand declined about 6% quarter over quarter, but increased about 2% year over year.
Speaker Change: As mentioned earlier, we have seen stronger demand growth and the SD channel, where we saw a S D demand grow about 4% quarter over quarter and about 14% year over year.
Jeffrey Ludwig: Let me now turn the call over to Heather and Roger for some additional insights.
Speaker Change: Let me now turn the call over to Heather and Roger for some additional insights.
Heather Blaber: Why don't we start with Heather Blaber, our VP of Marketing. Heather, the floor is yours. 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.
Speaker Change: Why don't we start with Heather Blaber, our VP of marketing Heather the floor is yours.
Heather Blaber: Thanks, Jeff.
Heather Blaber: I appreciate the opportunity to be on this call and share some more insights into the marketing strategy and execution.
Heather Blaber: As Jeff mentioned earlier, the marketing team is focused on increasing the utilization of neural links with a focus on patients who are at continued risk of occurrence.
Heather Blaber: 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.
Heather Blaber: 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 Neuralinks can play an important role in helping to reduce that risk.
Heather Blaber: We have utilized those insights to.
Heather Blaber: 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 neuro links can play an important role in helping to reduce that risk.
Heather Blaber: 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 neurolynx therapy. This educational resource will be provided to patients on a monthly basis as they receive their refill.
Heather Blaber: 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 neuro links therapy.
Heather Blaber: This educational resource will be provided to patients on a monthly basis as they receive their refills.
Heather Blaber: 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-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.
Heather Blaber: 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.
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.
Roger Storms: 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? Thanks, Heather. I also appreciate the opportunity to participate on the call and share my perspective.
Rogers: Turning over to our vice President of sales Rogers storms can provide some additional insights and perspective Roger.
Roger Storms: Thanks, Heather I also appreciate the opportunity to participate on the call and share My perspective, I joined <unk> 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 her two positive breast cancer patients. My focus is on execution excellence and expanding overall share of voice.
Roger Storms: 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 her two 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 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.
Roger Storms: 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.
Roger Storms: 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 establish a relationship chips with key customers.
Roger Storms: in regards to executional activities. 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 Neuralink.
Roger Storms: In regards to execution excellence.
Roger Storms: We are focused on helping ourselves reps get in front of more customers with the goal of increasing engagement when clinical decisions are being made.
Roger Storms: We're utilizing claims data non personal promotion feedback and piloting predictive analytics to help our teams prioritize their time and maximize our 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 narrow links.
Jeffrey Ludwig: Thanks, Roger, and thanks, Heather, for providing additional specifics and insights.
Speaker Change: Thanks, Roger and thanks, Heather for providing additional specifics and insights let.
Jeffrey Ludwig: 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 6, slide 6 highlights the quarterly adoption of dose escalation since Neuralink's launch. In Q1, approximately 72% of patients started Neuralink's at a reduced dose. similar to the 74% we reported in Q4 of 2024. Continued messaging and adoption of dose escalation remains an important commercial priority. Patients who are started on NeurLynx 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 NeurLynx therapy and ultimately help them reduce the risk of reoccurrence.
Speaker Change: Let me wrap up with just a few more slides and I will turn the call over to Maximo for a more detailed financial review.
Speaker Change: Turning to slide six slide six highlights the quarterly adoption of dose escalation since neural links launch in Q1, approximately 72% of patients started in airlinks at a reduced dose.
Speaker Change: Similar to the 74% we reported in Q4 of 2024.
Speaker Change: Continued messaging and adoption of dose escalation remains an important commercial priority patients who were started on airlinks utilizing dose escalation had better persistence and compliance.
Speaker Change: We believe dose escalation coupled with the new patient education resource Heather discussed will give patients better support throughout their new Orleans therapy, and ultimately help them reduce the risk of recurrence.
Speaker Change: Yeah.
Jeffrey Ludwig: Slide 7 highlights the strategic collaborations we have formed across the globe. In Q1 of 2025, Neuralinks was launched in Libya in the extended adjuvant setting and we signed a distribution agreement with IRCIM 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.
Speaker Change: Slide seven highlights the strategic collaborations we have formed across the globe in Q1 of 'twenty twenty-five neuro links was launched in Libya in the extended adjuvant setting and we signed a distribute distribution agreement with air Canada for select countries in Eastern Europe and Central Asia.
Speaker Change: We really appreciate the excellent work being done by our partners around the globe and look forward to supporting their continued success moving forward.
Jeffrey Ludwig: 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.
Speaker Change: Let me wrap up by thanking the entire Puma team once again for their 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.
Maximo Nougues: I'll now turn the call over to Maximo for a review of our full financial results. Maximo? Thanks, Jeff.
Speaker Change: I'll now turn the call over to Maximo for a review of our full financial results maxima.
Maximo: Thanks, Jeff I will begin with a brief summary of our financial results for the first quarter of 2025.
Maximo Nougues: I will begin with a brief summary of our financial results for the first quarter of 2021. Please note that I will make comparisons to Q4 2024, which we believe is a better indication of our progress as a commercial company than year-over-year comparisons.
Maximo: Please note that I will make comparisons to Q4 2024, which we believe is a better indication of our progress as a commercial company than year over year comparisons.
Maximo Nougues: For more information, I recommend that you refer to our first quarter 2025 thank you, which will be filed today and includes our consolidated financial statements. In the first quarter of 2025, we reported net income based on GAAP of $3 million, or $0.06 per share. This compares to net income in Q4 2024 of 19.3 million or 39 cents per share. In the fourth quarter of 2024, we released a portion of our valuation allowance resulting in a non-cash deferred income tax benefit of $7.1 million. Evaluation allowance was established to offset our deferred tax assets, which are primarily related to our historical losses.
Maximo: For more information I recommend that you referred to over first quarter 2025. Thank you.
Maximo: It will be filed today.
Maximo: And includes our consolidated financial statements.
Maximo: For the first quarter of 2025, we reported net income based on gap of $3 million or success per share.
Maximo: This compares to net income in Q4, 'twenty, 'twenty, $419 3 million or <unk> 39 per share.
Maximo: And the first and the fourth quarter 'twenty 'twenty four we release a portion of our valuation allowance resulted in a noncash deferred income tax benefit of $7 1 million.
Maximo: Evaluation allowance was established to offset our deferred tax assets, which are primarily related to our historical losses.
Maximo: This significantly increased our net income.
Maximo Nougues: Secondly, increase our net income. on a non-gap basis, which is adjusted to remove the impact of stock-based compensation expense. We reported net income of $5 million, or $0.10 per basic and diluted share, for the first quarter of 2025. Gross revenue from Netlink sales was $54.4 million in Q1 2025 and $66.5 million in Q4 2025. Alan mentioned it, net product revenue from Netlink sales was $43.1 billion. Lower net revenue was driven mostly by seasonality of inventory fluctuations. higher gross-to-net expenses than prior quarter. Inventory drawdown by our distributors was approximately 4.7 million in Q1 versus an increase of approximately 3.7 million in Q4 2021.
Maximo: Yeah.
Maximo: A non-GAAP basis, which is adjusted to remove the impact of stock based compensation expense, we reported net income of $5 million or 10 cents per basic and diluted share.
Speaker Change: For the first quarter of 2025.
Speaker Change: Gross revenue from Nellix sales was $54 4 million in Q1 'twenty to 'twenty five.
Speaker Change: $66 5 million in Q4 2024.
Speaker Change: Alan mentioned that net product revenue from <unk> sales was $43 1 million a decrease from the $54 4 million reported in Q4 2024.
Speaker Change: The lower net revenue was driven mostly by seasonality of inventory fluctuation I.
Speaker Change: Higher gross to net expenses than prior quarter.
Speaker Change: Inventory drawdown by hour by hour by hour distributors was approximately $4 7 million in Q1.
Speaker Change: Versus an increase of approximately $3 7 million in Q4 'twenty to 'twenty four.
Maximo Nougues: Royalty revenue totaled $2.9 million in the first quarter of 2025 compared to $4.7 million in Q4 2025. Our gross net adjustment in Q1 2025 was about 20.8% compared to 18.2% gross net adjustment reported in Q4 2025. Coftel's sales for Q1 2025 declined to $10.6 million and includes $2.4 million. fungible assets related to our neurodegenerative life. Kafton Cells for Q4 2024 was $13.9 million. Going forward, we will continue to recognize amortization of our milestones to the licensors, about $2.4 million per quarter as cost of sale. For fiscal year 2025, Puma anticipates that net Netelix product revenue will be in the range of $192 to $198 million.
Speaker Change: Royalty revenue totaled $2 9 million in the first quarter of 2025 compared to $4 7 million in Q4 2024.
Speaker Change: Our gross to net adjustment in Q1, 2025 was about 28% compared to 18, 2% gross to net adjustment reported in Q4 2024.
Speaker Change: Cost of sales for Q1, 'twenty 'twenty five declined to $10 6 million and includes $2 4 million.
Speaker Change: And Joel assets related to our <unk> license.
Speaker Change: Cost of sales for Q4, 2024 was $13 9 million.
Speaker Change: Going forward, we will continue to recognize amortization of our milestones with the license source about $2 4 million per quarter as cost of sales.
Speaker Change: Okay.
Speaker Change: For fiscal year 'twenty to 'twenty, five Puma anticipates, the net nellix product revenue will be in the range of $190 million to $298 million.
Maximo Nougues: We also anticipate that our gross net adjustment for the full year 2025 will be between 20.5% and 21.5%. In addition, for fiscal year 2025, we anticipate receiving royalties from our partners around the world in the range of $20 to $24 million. lower than 2024 due to fewer shipments expected to China as our partner works through regulatory transitions during the first several quarters of 2025.
Speaker Change: We also anticipate that gross to net adjustment for the full year 2025 will be between 25% and 21, 5%.
Speaker Change: In addition for fiscal year 'twenty to 'twenty five we anticipate receiving royalties from our partners around the world in the range of $20 million to $24 million.
Speaker Change: Lower than 2024 due to fewer shipments expected to China as our partner works through a regulatory transitions during the first several quarters of 'twenty to 'twenty five.
Maximo Nougues: 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 to $28 million. 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.
Speaker Change: We don't expect license revenue in 2025.
Speaker Change: We also expect that net income for the full year will be in the range of 23 to 28 million.
Speaker Change: We are not forecasting any potential release of any additional tax asset valuation allowance in our net income estimate at this time.
Speaker Change: However, this will be evaluated on an ongoing basis, we will continue to keep investors updated on this as it progresses.
Maximo Nougues: 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 cost accounts for a mid to high single-digit percentage of our total cost of goods sold. We anticipate that for Q2 2025, Netlink's product revenue net will be in the range of $48 to $50 million.
Speaker Change: 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.
Speaker Change: However, shifting trade policies in the United States and other countries have been rapidly evolving and are difficult to predict.
Speaker Change: A point of reference our manufacturing product costs account for a mid to high single digit percentage of our total cost of goods sold.
Speaker Change: We anticipate for Q2 2025, Nellix protocols revenue net will be in the range of $48 million to $50 million.
Maximo Nougues: Also, we expect Q2 royalty revenue will be in the range of $2 to $3 million and no licensed revenue. We further estimate that the gross net adjustment in Q2 2025 will be approximately 20% to 21.5%. Puma anticipates Q2 net income between $4 million and $6 million. SG&A expenses were $17.6 million in the first quarter of 2025 compared to $16.6 million in the fourth quarter of 2024. The non-cash charges for stock-based compensation of $1.2 million for Q1 and $1.3 million for Q4 2025. Research and Development Expenses were $13.8 million in the first quarter of 2025, a decrease from $15.2 million in the fourth quarter of 2025.
Speaker Change: Also we expect Q2 royalty revenue will be in the range of $2 million to $3 million.
Speaker Change: License revenue.
Speaker Change: We further estimate that the gross to net adjustment in Q2, 2025 will be approximately 20% to 21, 5%.
Speaker Change: Four months dissipates Q2, net income between 4 million and $6 million.
Speaker Change: Yeah.
Speaker Change: SG&A expenses were $17 6 million in the first quarter of 2025 compared to $16 6 million in the fourth in the fourth quarter of 2024.
Speaker Change: SG&A expenses included noncash charges for stock based compensation of $1 2 million for Q1, and one 3 million for Q4 'twenty to 'twenty four.
Speaker Change: Research and development expenses were $13 9 million in the first quarter of 2025.
Speaker Change: Decrease from $15 2 million in the fourth quarter of 2020 for R&D.
Maximo Nougues: R&D expenses included non-cash charges for stock-based compensation of $0.8 million in the first quarter of 2025 compared to $0.5 million in the fourth quarter of 2025.
Speaker Change: R&D expenses included non cash charges for stock based compensation of Cedar point 8 million in the first quarter of 2025 compared to <unk> 5 million in the fourth quarter of 224.
Maximo Nougues: On the expense side, Puma anticipates flat to slightly lower total operating expenses in 2025 compared to 2024. More specifically, we anticipate SG&A expenses to decrease by 5% to 10%. and R&D expenses to increase by 10-15% year over year. In the first quarter of 2025, Puma reported cash burn of approximately $7.8 million. This compares to cash earned of approximately $4.3 million in Q4 2025. Please note that during Q1, we made our fourth 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 $56,000.
Speaker Change: On the expense side, Puma anticipates flat to a slightly lower total operating expenses in 2025 compared to 2024.
More specifically, we anticipate SG&A expenses to decrease by 5% to 10%.
Speaker Change: And R&D expenses to increase by 10% to 15% year over year.
Speaker Change: In the first quarter of 2025, we might reported cash burn of approximately $7 8 million.
Speaker Change: This compares to cash burn of approximately $4 3 million in Q4, 'twenty 'twenty four.
Speaker Change: Please note that during Q1, we made our fourth principle loan payment of $11 1 million related to our obligation with that theory.
Speaker Change: As a result of this our total outstanding principal debt balance decreased to approximately $56 million.
Maximo Nougues: March 31st, 2025, we had approximately 93 million in cash, cash equivalents and marketable security. versus about 101 million at year-end in 2024. Our accounts receivable balance was $24.2 million. Our accounts receivables terms range between 10 and 68 days. while our day sales outstanding are about 50 days. We estimate that as of March 31st, 2025, our distribution network maintain approximately three weeks of inventory.
Speaker Change: At March 31st 2025, we had approximately 93 million in cash cash equivalents and marketable securities.
Speaker Change: <unk> was about $101 million a year ending 2024.
Speaker Change: Our accounts receivable balance was $24 2 million.
Speaker Change: Our accounts receivable terms range between 10 and 68 days.
Speaker Change: While our days sales outstanding at about 50 days.
Speaker Change: We estimate that as of March 31st 2025.
Speaker Change: Our distribution network maintain approximately three weeks of inventory.
Maximo Nougues: Overall, we continue to deploy our financial resources to focus on the commercialization of Neuralinks, the development of Alizertif, and controlling our expenses. Thanks, Maximo. Puma Senior Management, in cooperation with the Board of Directors, continues to remain focused on near-link 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 2025 and the company is guiding to for full year 2021.
Speaker Change: Overall, we continue to deploy our financial resources to focus on the commercialization of New Orleans, the development of Alisha and controlling our expenses.
Maximo: Thanks Maximo.
Maximo: Puma Senior management in cooperation with the board of Directors continues to remain focused on nearly sales trends in 2025 and beyond.
Maximo: And recognize its fiscal responsibility to the shareholders to continue to maintain positive net income.
Maximo: We believe its positive net income that was seen in fiscal years 2023, and 2024 resulted from the financial discipline across the company over the last three years the expense reductions that we have previously performed and continue to perform are also a major contributor to the positive net income that.
Maximo: That the company achieved in Q1 2025, and the company is guiding to for full year 2025.
Maximo Nougues: The company remains committed to continuing to achieve this positive net income and will continue to reduce expenses if needed to achieve this.
Maximo: 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.
Maximo Nougues: We look forward to updating investors on this in the future.
Maximo Nougues: There 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.
Speaker Change: To remain a significant unmet medical need for patients battling breast cancer lung cancer and other solid tumors.
Speaker Change: We had puma are committed and passionate about finding more effective ways and helping these patients during their journey and we will continue to strive to achieve that goal.
Maximo Nougues: This concludes today's presentation.
Speaker Change: This concludes today's presentation, we will now turn the floor back to the operator for Q&A operator.
Operator: We will now turn the floor back to the operator for Q&A.
Operator: Operator? Thank you.
Speaker Change: Thank you we will now begin the question and answer session. If you wish to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue. If you wish to withdraw your request. Please press star kill for participants using speaker equipment, it may be necessary to pick up your handset.
Operator: We will now begin the question and answer session. If you wish to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. If you wish to withdraw your request, please press star 2. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key.
Speaker Change: Before pressing the star keys, one moment, while we poll for questions.
Operator: One moment while we pull for questions.
Operator: Our first question is from Divya Rao with Cowen and Company. Please proceed.
Speaker Change: Our first question is from David <unk> with Cowen and company. Please proceed.
Divya Rao: Hi, Alan. Thanks for taking my questions. This is Divya on for Marc.
David: Hi, Alan.
David: Thanks for taking my questions are this is David on for Mark I just had two questions.
Divya Rao: I just had two questions on Alicertib.
Divya Rao: One, I guess, could you talk about where the Alicertib IP is held? Is it in Ireland? Is it in the US?
David: Two questions on Alicertib. One, I guess, could you talk about where the Alicertib IP is held?
Divya Rao: And then also, manufacturing, the comments that you made, was that just related to Neuralink's manufacturing? Or is that similar for Alicertib as well?
David: and Ireland is in the U.S. and then also manufacturing. The comments that you made was that just related to narrow links, manufacturing, or is that similar for Alistair to this bill, as well and then I have a second question.
Divya Rao: And then I have a second question.
Alan Auerbach: 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 Alicertib 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. Now on the manufacturing, I believe it is mostly done in the U.S.
Thank you.
Speaker Change: 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.
Speaker Change: The origin of Al assertive is that it was originally developed by Millennium, which is, you know, 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's a great question I just don't have the information in front of me
Speaker Change: Now on the manufacturing, I believe it is mostly done in the U.S. if I'm remembering this correctly.
Alan Auerbach: 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.
Speaker Change: Currently. Now obviously we're not at commercial scale and you know we obviously will take
Speaker Change: Interaccount, you know, tariffs and futures tariffs and things like that in the future.
Speaker Change: But I believe right now my remembrance of this is that we're doing it on the U.S.
Divya Rao: Okay, that's helpful. Thank you. Do you have another question on the IP? Yeah, I kind of cut you off there, I apologize. Oh, no worries, no worries. I think you answered it. Thank you.
Okay, that's helpful. Thank you.
Speaker Change: Do you have another question on the IP? Yeah, I kind of cut you off there. I apologize.
Speaker Change: Oh, no worries. No worries. I'm having you answered it. Thank you. Thank you [inaudible]
Kun Wang: Our next question is from Gina Wong with Barclays. Please proceed.
Gina Wong: Our next question is from Gina Wang with Barclays, please proceed.
Kun Wang: Hi, this is Kun Wang. On behalf of Gina Wang from Bioclase, we have a few questions.
Kun Wang: Hi, this is Kun Wang. On behalf of Gina Wang from Barclays, we have a few questions.
Kun Wang: For elicited 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 look like based on the current dose?
Speaker Change: for elicitate, lung cancer, fist to trial. You just mentioned the protocol amendment for those who increase.
Speaker Change: 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 look like based on the current dose?
Kun Wang: Second question is for the neonics phase one data presented at SECR25. So some tumor types, like pancreatic cancer, showed a better response than others.
Speaker Change: The second question is for the Neonix Phase I data presented at SECR25. So some tumor types like a pancreatic cancer showed better response than others. How would you select a tumor type moving forward? And what magnitude of PFS improvement is expected based on the response data?
Kun Wang: How would you select a tumor type moving forward? And what magnitude of PFS improvement is expected based on the response data?
Alan Auerbach: And lastly, we would like to ask your view on the impact from the Medicare Part D redesign, and also the new CBER director and the potential impact on the drug approval path. Thank you. Let me handle the first two. With regard to the small cell lung cancer, so we are amending the protocol to go from 50 to 60 milligrams. In the prior monotherapy trials of Alisertib, if I remember correctly, they went up as high as 100 milligrams. So I think we're assuming we're going to be OK to go up to 60. I don't have the data in front of me in terms of, you know, 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, you know, response rates and things like that.
Speaker Change: And lastly, we would like to ask your view on the impact from the Medicare Part D redesign and also the new seabird director and the potential impact on the drug approval test. Thank you.
Speaker Change: Let me add on the first two. With regard to the small cell lung cancer so we are preventing the protocol.
Speaker Change: to go from 50 to 60 milligrams in the prior monotherapy trials of Alessertib. If I remember correctly, they went up as high as 100 milligrams, so I think we're assuming we're going to be okay to go up to 60.
Speaker Change: I don't have the data in front of me in terms of, you know, what we would expect in terms, obviously we haven't dosed the patients that that will have the yet, so I don't have the data in front of me in terms of what we'd expect in terms of changes and you know, 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
Alan Auerbach: 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 at the higher doses. We still are planning to have data later this year. Obviously, the quicker we can get the amendment done and enroll patients, the more patients that 60 milligrams we can have, so I can't really speculate on that.
Speaker Change: Better activity in the patients where the rare kind is pathway played a role. We would expect we would probably see something similar to that in at the higher doses as well.
Speaker Change: We still are planning to have data later this year. Obviously the quicker we can get the amendment done in rural patients, the more patients that 60 milligrams we can have, so I can't respectfully done that right now.
Alan Auerbach: With regard to the Neuralink's Phase 1, you are correct that we did tend to see more activity in the combination of Neuratinib with Inhertu. The reason for that is mechanistically based, which is that, you know, Neuratinib being an irreversible HER2 inhibitor, it internalizes the HER2 receptor, so because of that, if you have an ADC, you know... 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 with an HER2, like pancreatic, we're seeing the better activity with the combination.
Speaker Change: With regard to the Neuralinx Phase I, you are correct that
Speaker Change: We did tend to see more activity in the combination of Naratnib with Inheritoo. The reason for that is mechanistically-based, which is that, you know,
Speaker Change: Naratina being an irreversible HER2 inhibitor. It internalizes the HER2 receptor. So because of that, if you have an ADC, you know...
Speaker Change: Perception is what you're doing is you're bringing more of the ADC into the cell, that maybe why we are seeing in tumor types where you historically have not seen much activity within her tube, like pancreatic, we're seeing the better activity with the combination.
Alan Auerbach: 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, et cetera. 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.
Speaker Change: Not clear what we would expect, I think we'd need more data to be able to say what we expect in terms of
Speaker Change: You know, in ORR, PFAS, etc. But there's no question we are extremely encouraged by it. My understanding is that they've...
Speaker Change: 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, you know, later this year, and I think they're my understanding as they're looking to present it publicly at a scientific conference, probably in the first half of 26 is my recollection.
Alan Auerbach: And I think they're, my understanding is they're looking to present it publicly at a scientific conference probably in the first half of 26 is my record. In terms of your commentary on the FDA, that's C-BRRR, we go through C-DIRR, so not a whole lot we can really add in value.
Speaker Change: Uh, in terms of your commentary on the FDA, uh, at C-Bur, we go through C-Dur, uh, so not a lot, we can really add in value. And if you repeat your question on the Medicare, please.
Alan Auerbach: And if you could repeat your question on the Medicare, please. Yes, so your view on the impact from Medicare Part D redesign in 2026 to 2017. So in terms of, you're talking about the Medicare redesign that was part of the IRA, is that what you're asking about? Yes. Yeah, so yeah, great question. So we've been paying attention to that what we've seen from the IRA portion is that copay for patients have actually declined somewhat in 25 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.
Speaker Change: Yeah, so your view on the impact from Medicare Part D redesign in 2026 to 27.
Yeah.
Speaker Change: So in terms that you're talking about the Medicare redesign, it was part of the IRA, is that what you're asking about? I guess
Speaker Change: Yeah, so yeah, 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 25 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.
Kun Wang: So it's actually been helpful to us and it's made it slightly more affordable for patients to get on and stay on NeurLynx. Does that answer your question? Thank you. Yes. Thank you.
Speaker Change: So it's actually been helpful to us and it's made it slightly more affordable for patients to get on and stay on their links [inaudible]
Does that answer your question? Thank you.
Operator: This concludes our question and answer session. I would like to turn the conference call back over to Mariann for closing remarks. Thank you all for joining us today. As a reminder, this call may be accessed via replay of the webcast at pumabiotechnology.com, beginning later today. Have a good evening. Ladies and gentlemen, thank you for participating in today's conference call. This concludes our program. Everybody have a great day.
Speaker Change: This concludes our question and answer session. I would like to turn the conference call back over to Marianne for closing remarks.
Speaker Change: Thank you all for joining us today. As a reminder, this call may be accessed via replay of the webcast at Puma Biotechnology.com beginning later today. Have a good evening.
Speaker Change: 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.
Auerbach, Maximo
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