Q3 2025 Puma Biotechnology Inc Earnings Call

Speaker #3: Good afternoon . My name is Julian and I will be your conference call operator today . At this time , all participants are in a listen only mode .

Speaker #3: After the speaker's formal remarks , there will be a question and answer session . If you'd like to ask a question during that time , simply press the star key .

Speaker #3: 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 .

Speaker #3: As a reminder , this call is being recorded . I would now like to turn the conference call over to Mariann Ohanesian Senior Director of IR for Puma Biotechnology Inc .

Speaker #3: Thank you . You may begin .

Speaker #4: Thank you . Julian . Good afternoon and welcome to Puma's conference call to discuss our earnings results for the third quarter of 2025 .

Speaker #4: 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 .

Speaker #4: And Roger Stormes , senior vice president of sales . After the close today , Puma issued a news release detailing earnings results for third quarter 2025 .

Speaker #4: 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 Puma Biotechnology Inc .

Speaker #4: The webcast and presentation slides will be archived on our website and available for replay for the next 90 days . Today's conference call will include statements about Puma's future expectations , plans and prospects that constitute forward looking statements for purposes of federal securities laws .

Speaker #4: Such statements are subject to risks and uncertainties and actual events and results may differ from those expressed in these forward looking statements . For a full discussion of these risks and uncertainties , please review our periodic and current reports filed with the SEC from time to time , including our annual Report on Form 10-K for the year ended December 31st , 2024 .

Speaker #4: You are concerned not to place undue reliance on these forward looking statements , which speak only as of the date of this live conference call November 6th , 2025 .

Speaker #4: Puma undertakes no obligation to revise or update any forward looking statements to reflect events or circumstances after the date of this conference call , except as required by law .

Speaker #4: During today's call , we may refer to certain non-GAAP financial measures that involve adjustments to our GAAP figures . We believe these non-GAAP metrics may be useful to investors as a supplement to , but not as substitute for , our GAAP financial measures .

Speaker #4: Please refer to our third quarter 2025 earnings release for a reconciliation of our GAAP to non-GAAP results . I will now turn the call over to Alan .

Speaker #5: Thank you . Marianne , and thank you all for joining our call today . Today , Puma reported total revenue for the third quarter of 2025 of 54.5 million .

Speaker #5: Total revenue includes product revenue , net , which consists entirely of Neuralink sales as well as royalties from our Sublicensees . Product revenue , net was 51.9 million in the third quarter of 2025 , an increase from 49.2 million reported in Q2 2025 , and a decrease from 56.1 million reported in Q3 2024 .

Speaker #5: As a reminder to investors , Puma reported Nerlynx sales includes both US net sales of Nerlynx and product supply revenues of Nerlynx to Puma's US partners .

Speaker #5: Please note that in Q3 2024 , we reported product supply revenue to our international partners of about 7.4 million versus 0.1 million in Q3 2025 .

Speaker #5: Therefore , US net sales of Nerlynx in Q3 2025 were 51.8 million versus 48.8 million in Q3 2024 . Product revenue for the third quarter of 2025 was impacted by approximately 3.1 million of inventory build at our specialty pharmacies and specialty distributors .

Speaker #5: Royalty revenue was 2.6 million in the third quarter of 2025 , compared to 3.2 million in Q2 2025 and 24.4 million in Q3 2024 .

Speaker #5: Q3 2024 royalty revenue included sales to China by our offshore partner , Pierre-fabre . We reported 2949 bottles of Nerlynx sold in the third quarter of 2025 .

Speaker #5: An increase of 341 from the 2608 bottles sold in Q2 2025 . In Q3 2025 , we estimate that inventory increased by 172 bottles in Q3 2025 .

Speaker #5: New prescriptions were down approximately 3% compared to Q2 2025 , and total prescriptions were down approximately 1% compared to Q2 2025 . Roger will provide further details in his comments and slides .

Speaker #5: I will now provide a clinical review of the quarter , then Heather Blaber and Roger storms will add additional color on Nerlynx commercial activities .

Speaker #5: Maximo Nougues will follow with highlights of the key components of our financial statements for the third quarter of 2025 . As investors are aware , Puma currently has two ongoing phase two trials of our investigational drug Alisertib Alaska Breast one , which is a phase two trial of alisertib in combination with endocrine treatment in patients with Her2 negative hormone receptor positive breast cancer and Alaska Lung one , a phase two trial looking at the efficacy of alisertib monotherapy in patients with small cell lung cancer .

Speaker #5: As a reminder , the breast one trial investigates Ala in combination with endocrine treatment , which consists of either anastrozole , exemestane , letrozole , fulvestrant , or tamoxifen .

Speaker #5: In patients with Her2 negative hormone receptor positive metastatic breast cancer . Patients must be chemotherapy naive , have been previously treated with a Cdk4 six inhibitor , and received at least two prior lines of endocrine therapy in the Or metastatic setting .

Speaker #5: To be eligible for this trial, patients are being dosed with Assertive given at either 30 mg, 40 mg, or 50 mg twice daily.

Speaker #5: Bid on days 1 to 3 , 8 to 10 , and 15 to 17 , and a 28 day cycle in combination with the endocrine therapy and investigator's choice .

Speaker #5: Patients must not have been previously treated with the endocrine treatment and the metastatic setting that will be given in combination with alisertib . In the trial , the primary efficacy endpoints include objective response rate , duration of response , disease control rate , and progression free survival .

Speaker #5: As a secondary objective , the company will be evaluating each of these efficacy biomarkers within biomarker subgroups in order to determine whether any biomarker subgroup correlates with better efficacy , and has been seen in .

Speaker #5: As has been seen in 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 alisertib in combination with endocrine therapy for patients with Her2 negative hormone receptor positive breast cancer .

Speaker #5: With these biomarkers , the trial was initiated in late November 2024 . There are currently 34 sites in the US and 18 sites in Europe that have been activated for the trial , and the trial is rolling ahead of expectations .

Speaker #5: There are currently 98 patients enrolled in the trial and 14 additional patients in screening . Due to the faster than expected enrollment in the trial , the former interim analysis was triggered sooner than expected .

Speaker #5: We anticipate that the formal interim analysis will be completed in the first half of 2026 and look forward to sharing this with investors at that time .

Speaker #5: With respect to the Alaska Lung Study . The Alaska lung is a phase two study 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 .

Speaker #5: 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 #5: In that randomized trial , a progression free survival benefit and overall survival benefit were seen in patients with biomarkers which correlate with the Aurora kinase pathway .

Speaker #5: 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 the data obtained to date from the Alaska Lung one is providing a preliminary indication of potentially better activity in patients with biomarkers .

Speaker #5: With Aurora kinase plays a role . The most recent analysis of the PK data from the lung suggests that we're seeing lower pKa of Alisertib and the Alaska one study compared to the previous phase two of Alisertib monotherapy and small cell lung cancer patients .

Speaker #5: That was published in Lancet Oncology . The company has amended the protocol for the trial to increase the dose of alisertib from 50mg bid to 60mg bid , which the company believes will increase the PK of the drug to levels closer to what was seen in prior The company is currently enrolling patients at the 60mg dose , 60mg bid dose .

Speaker #5: There are currently 61 patients in the trial , with nine of these patients enrolled at the 60mg bid dose and an additional two patients in screening .

Speaker #5: Assuming the safety at the 60 mg dose is acceptable, the company plans to meet with the FDA in order to amend the protocol to continue to dose escalate to 70 mg bid.

Speaker #5: Assuming the safety at the 60mg dose is acceptable , the company plans to meet with the FDA in order to amend the protocol to continue to dose escalate phase two .

Speaker #5: company looks to have additional interim data from this trial . In the first half of 2026 , as mentioned on prior earnings calls and a response to investor questions , Puma continues to evaluate several drugs to potentially in-license or acquire that would allow the company to diversify itself and leverage Puma's existing R&D , regulatory and commercial infrastructure .

Speaker #5: 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 #5: Roger Storms will follow with a review of our commercial performance during the quarter .

Speaker #6: Thank you . 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 messaging for Neuralink's as well as recently published data that demonstrate the continued need to reduce the risk of recurrence in Her2 positive early breast cancer .

Speaker #6: After treatment with adjuvant therapy , we continue to invest in market research to help us better understand risk factors that put a patient at high risk of recurrence in Her2 positive early stage breast cancer .

Speaker #6: As well as garner insights on the Neuralink's clinical data in this patient population . Together with our marketing initiatives , our strategy is focused on increasing awareness of our broad indication of patients that are appropriate for treatment with Neuralink's , we have adjusted our strategy based on our learnings and revised both personal and non-personal messaging with the goal of engaging physicians on a broader set of patients where the risk of recurrence still remains high , and where we believe neuralink's can play an important role in helping to reduce the risk of recurrence in patients with early stage Her2 positive breast cancer .

Speaker #6: In addition to revising our messaging , we have a new resource to support patients throughout their recommended course of neuralink's therapy . This educational resource is provided to patients on a monthly basis with a goal of improving patient adherence as they receive their refills .

Speaker #6: Lastly , year to date , we have reached 99.7% of oncologists through non-personal promotion and continue to expand our share of voice , working closely with the sales team to increase engagement with healthcare providers .

Speaker #6: In summary , we are excited about our new marketing strategy and messaging , which we believe will continue to help educate and engage oncologists on the unmet need for those diagnosed with Her2 positive early breast cancer .

Speaker #6: I will now turn the call over to Roger storms to provide an overview on the commercial performance for the third quarter .

Speaker #5: Thank you , Heather , and thanks to everyone for joining our third quarter earnings call . Before I move into the Commercial review , just a reminder that I'll be making forward looking statements .

Speaker #5: The sales team remains focused on expanding overall HCP reach and frequency, with a strong emphasis on driving engagement at key treatment decision points. In Q3 2025, call activity increased 22% year over year and increased 17% quarter over quarter.

Speaker #5: This is a direct result of continued emphasis put on Executional excellence and increased accountability with the existing sales team . I expect call activity to continue to improve as we fill vacancies .

Speaker #5: Commercial team continues to prioritize increasing the use of Nerlynx , with the main focus on patients at higher risk of recurrence . There are also dedicated to enhancing clinical education and engagement through non-personal promotional efforts , as well as utilizing patient resources to support persistence and compliance .

Speaker #5: 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 .

Speaker #5: In to overall distribution of our business in Q3 2025 , about 65% of our business was purchased through the SPX channel , and the remaining 35% was purchased through the SD channel .

Speaker #5: We are seeing some stronger growth in the SD channel, driven by two main factors: one, increased sales in the group purchasing organization segment, and two, increased 340B purchasing.

Speaker #5: Turning to slide for Neuralink's net product revenue in Q3 2025 was 51.9 million , which represents an increase of 2.7 million from the 49.2 million we reported in Q2 2025 .

Speaker #5: And a decrease of 4.2 million from the 56.1 million we reported in Q3 of 2024 . As a reminder to investors , Puma's reported nerlynx sales includes both US sales of Nerlynx and product supply revenues of Nerlynx to Puma's partners .

Speaker #5: Please note that in Q3 2024, we reported product supply revenue to our international partners of about $7.4 million versus the $0.1 million in Q3 of 2025.

Speaker #5: Therefore , US net sales of Nerlynx in Q3 2025 were 51.8 million versus the 48.8 million in Q3 of 2024 . 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 Q3 of 2025 , we estimate that inventory increased by about 3.1 million .

Speaker #5: As a comparator , we estimate that inventory decreased by about 1.3 million in Q2 of 2025 , and increased by about 0.7 million in Q3 of 2024 .

Speaker #5: Slide five shows Q3 2025 . Ex-factory Bottle sales and also provides both a year over year and a quarter over quarter comparison in Q3 2025 .

Speaker #5: Nerlynx ex-factory bottle sales were 2,949, which represents an approximate 13% increase quarter over quarter and an 8% increase year over year. Inventory declined for the first two quarters but increased in Q3 of 2025.

Speaker #5: Similar to the prior slide , let me specifically call out the inventory changes from a bottle perspective in Q3 2025 . We estimate the inventory increased by 172 bottles as a comparator , we estimate that inventory decreased by 85 bottles in Q2 of 25 , and increased by 39 bottles in Q3 of 2024 .

Speaker #5: Let me take a moment to provide some additional metrics regarding our second quarter performance in Q3 . We saw enrollments increase by about 6% quarter over quarter and decline about 6% year over year .

Speaker #5: New patient starts are interacts , follow a similar pattern , increasing 3% quarter over quarter and declining about 1% year over year . Turning to total prescriptions , or TRX , we saw TRX decline about 1% quarter over quarter and decline of about 4% year over year .

Speaker #5: Finally, let me share some specifics around demand in Q3 2025. We saw demand increase by about 3% quarter over quarter and about 3% year over year.

Speaker #5: As mentioned earlier , we have seen stronger demand growth in the SD channel where we saw SD demand grow by about 11% quarter over quarter and about 25% year over year .

Speaker #5: Side slide six highlights the quarterly adoption of dose escalation since Neuralink's launch in Q3 2025 . Approximately 77% of patients started nerlynx at a reduced dose .

Speaker #5: This is higher compared to the 71% we reported in Q2 of 2025 , continued messaging and adoption of dose escalation remains an important commercial priority .

Speaker #5: Patients who are started on Nerlynx utilizing dose escalation have better persistence and compliance . We believe dose escalation , coupled with the new patient education resources , will give patients better support throughout their nerlynx therapy and ultimately help them reduce their risk of recurrence .

Speaker #5: Slide seven highlights the strategic collaborations we formed across the globe . We really appreciate the excellent work being done by our partners around the world .

Speaker #5: And look forward to supporting their continued success . Moving forward . Let me close by expressing my heartfelt gratitude to the entire Puma team for their unwavering passion and dedication to supporting patients and families affected by breast cancer .

Speaker #5: This disease can be devastating and we recognize there is still more work to do and more that can be done . I'll now turn the call over to Maximo for a review .

Speaker #5: A review of our financial results .

Speaker #7: Thanks , Roger . I will begin with a brief summary of our financial results for the third quarter of 2025 . Please note that I will make comparisons to Q2 2025 , which we believe is a better indication of our progress as a commercial company than year over year comparisons .

Speaker #7: For more information , I recommend that you refer to our third quarter 2025 . Thank you . Which will be filed today and includes our consolidated financial statements for the third quarter of 2025 .

Speaker #7: We reported net income , based on GAAP of 8.8 million , or $0.18 per basic share , and $0.17 per diluted share . This compares to net income in Q2 2025 of 5.9 million , or $0.12 per share .

Speaker #7: On a non-GAAP basis , which is adjusted to remove the impact of stock based compensation expense . We reported net income of 10.5 million , or $0.21 per basic and diluted share , for the third quarter of 2025 .

Speaker #7: Gross revenue from Nerlynx sales was 70 million in Q3 2025 , and 62.1 million in Q2 2025 . As Alan mentioned , net product revenue from Nerlynx sales was 51.9 million , an increase from the 49.2 million reported in Q2 2025 and a decrease versus the 56.1 million reported in Q3 2024 .

Speaker #7: So reminder to investors Puma reported Nerlynx sales include both US net sales of Nerlynx and product supply revenue of Nerlynx to Puma's partners .

Speaker #7: Please note that in Q3 2024 , we reported product supply revenue to our international partners of about 7.4 million versus 0.1 million in Q3 2025 .

Speaker #7: Therefore, U.S. net sales of Nerlynx in Q3 2025 were $51.8 million versus $48.8 million in Q3 2024. The increase in Q3 2025 net revenue versus Q2 2025 was driven primarily by an increase in Na+ bottles sold in the U.S. inventory build of $3.1 million, offset by a higher gross-to-net expense. The inventory build by our distributors was approximately $3.1 million in Q3 versus a drawdown of approximately $1.3 million in Q2 2025.

Speaker #7: Royalty revenue totaled 2.6 million in the third quarter of 2025 , compared to 3.2 million in Q2 2025 . Our gross to net adjustment in Q3 2025 was about 25.9% , and 20.8% in Q2 2025 , the increase on gross to net was driven mostly by a higher than expected Medicare rebate , driven by the Inflation Reduction Act implemented in implemented in Q4 of 2022 and higher .

Speaker #7: Medicaid share . Costs of sales for Q3 2025 was 12.2 million and includes 2.4 million for the amortization of intangible assets related to our license sales for Q2 2025 was 12.3 million , going forward , we will continue to recognize amortization of the milestones to the licensor .

Speaker #7: About 2.4 million per quarter as cost of sales . For fiscal year 2025 , Puma anticipates that net Neuralink's product revenue will be in the range of 198 to 200 million , higher than our prior guidance .

Speaker #7: We also anticipate that our gross to net adjustment for the full year 2025 will be between 23% and 23.5% . In addition , for fiscal year 2025 , anticipate receiving royalties from our partners around the world in the range of 22 to 23 million , lower than 2024 due to the fewer shipments expected to China .

Speaker #7: As our partner works through regulatory transitions during the first several quarters of 2025 , 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 we 27 to 29 million , the current guidance does not include any potential release of any additional tax asset valuation allowance in our net income estimate , the company is reviewing its deferred tax assets as part of its ongoing tax valuation analysis , and has not yet determined whether any adjustment will be required or , if so , the potential timing or size of such an adjustment .

Speaker #7: We will continue to keep investors updated on this as it progresses . At this time , we do not believe the tariffs impose or proposed to be imposed by the United States , particularly with other countries , will have a material impact on our product costs or results of operations .

Speaker #7: However , shift in trade policies in the United States and other countries have been rapidly evolving and are difficult to as a point of reference , our manufacturing product cost accounts for a mid to high single digit percentage of our cost of goods sold .

Speaker #7: We anticipate that for Q4 2025 , Nerlynx product revenue , net will be in the range of 54 to 56 million . Please note that Q4 net product revenue guidance includes almost 4.5 million of product sales to one of our global partners .

Speaker #7: As well as US net revenue , which we will predict we expect to be in the range of 50 to 52 million . The cells to our global partners will also contribute to the large royalty revenue we expect in Q4 .

Speaker #7: We expect Q4 royalty revenue will be in the range of 13 to 14 million . And no license revenue . We further estimate that the gross to net adjustment in Q4 2025 will be approximately 24% to 25% , Puma anticipates Q4 net income between 9,000,011 million .

Speaker #7: SG&A expenses were 16.8 million in the third quarter of 2025 , compared to 18 million in the second quarter , as G&A expenses included non-cash charges for stock based compensation of 1.1 million for Q3 and 1 million for Q2 2025 .

Speaker #7: Research and development expenses were 15.9 million in the third quarter of 2025 , and 15.5 million in the second quarter . R&D expenses included non-cash charges for stock based compensation of 0.6 million in the third quarter of of 2025 , unchanged from the second quarter .

Speaker #7: On the expense side , Puma anticipates flat to slightly higher total operating expenses in 2025 compared to 2024 . More specifically , we anticipate SG&A expenses to decrease by 7 to 10% and R&D expenses to increase by 20 to 25% year over year .

Speaker #7: The higher increase in R&D is driven by faster enrollments in our clinical trials than previously expected . In the third quarter of 2025 , Puma reported cash burn of approximately 1.6 million .

Speaker #7: This compares to cash burn of approximately 2.9 million in Q2 . Please note that during Q3 , we made our sixth 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 33 million , at September 30th , 2025 .

Speaker #7: We had approximately 94 million in cash . Cash equivalents and marketable securities , versus about 101 million at the year end 2024 . Our accounts receivables balance was 33.6 million , our accounts receivable terms ranged between 10 and 68 days , while our day .

Speaker #7: Sales outstanding are about 50 days . We estimate that as of September 30th , 2025 , our distribution network maintained approximately 3.5 weeks of inventory .

Speaker #7: Overall, we continue to deploy our financial resources to focus on the commercialization of Neuralink, the development of Alisertib, and controlling our expenses.

Speaker #5: Thanks , Maximo . On past earnings calls , we have stressed that Puma's senior management and cooperation with the Board of Directors continues to remain focused on Nerlynx sales trends .

Speaker #5: In 2025 and beyond , and recognizes its fiscal responsibility to the shareholders to continue to maintain positive net income . We believe that this focus has contributed to our commercial execution in a positive way , as according to our current projections , 2025 will mark the first year over year demand increase for Nerlynx in the United States since 2018 .

Speaker #5: We are pleased to report this demand driven growth in Nerlynx sales for the first nine months of 2025 . In addition , we believe that the positive net income that the company achieved in Q3 25 and that the company is guiding to for the full year 2025 , has resulted from the continued financial discipline across the company over the last few years .

Speaker #5: 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 #5: The continues to remain a significant unmet need for patients battling breast cancer , lung cancer , and other solid tumors . We at Puma are committed and passionate about finding more effective ways of helping these patients during their journey , and we will continue to strive to achieve that goal .

Speaker #5: This concludes today's presentation . We will now turn the floor back to the operator for Q&A . Operator .

Speaker #3: Thank you . With that , we will now be conducting a question and answer session . If you wish to ask a question , please press star one on your telephone keypad .

Speaker #3: Confirmation to indicate that your line is in the question queue . If you choose to withdraw your request , please press star two .

Speaker #3: For participants using speaker equipment , it may be necessary to pick up the handset before pressing the star keys . One moment while we poll for questions .

Speaker #3: And our first question comes from the line of Mark Fram with TD Cowen . Please proceed with your question .

Speaker #8: Feeding my question . Maybe just looking forward to the breast cancer interim . Just just remind us what the kind of bar you're going to be evaluating that with in terms of , you know , willingness to continue to spend on that indication , particularly in light of your comments to end the prepared remarks of remaining committed to to staying profitable .

Speaker #5: Yeah . Thanks , Mark . So there's This is going to be alisertib in combination with endocrine . You'll remember there was a previous trial , Tbcrc 41 of Alisertib in combination with endocrine .

Speaker #5: And I think that's probably going to be the gauge we're looking for , you know , to see to compare to those numbers .

Speaker #5: You know , right now , as you know , the standard of care for er positive Her2 negative breast cancer is first line .

Speaker #5: They get a Cdk4 six inhibitor . Second line depending on , you know , which mutation they have , they may get a targeted therapy or may get a different type of a combination therapy .

Speaker #5: Third line is still kind of in a white space if you will . And that's where we're focusing is in that third line white space .

Speaker #5: So all these patients are kind of third line endocrine , if you will . So obviously we would look for in terms of continued spend would really be number one .

Speaker #5: How the efficacy compares to , you know , what we would typically expect . To be standard of care in third line . But then also , you know , assuming we're able to find a biomarker where , you know , it portends for or predicts a better outcome to alisertib , you know , that would obviously be quite compelling as well .

Speaker #5: So , you know , we've gotten asked that question in the past , which is , okay , you have both the breast and the lung .

Speaker #5: You know , you want to remain profitable . You know , as we've said in the past , and I will say again , you know , we're happy to stagger the indications , you know , to control the burn .

Speaker #5: So that we can , you know , remain a profitable company .

Speaker #8: Okay . That's helpful , but I guess the next steps could ultimately involve , you know , a larger , you know , pivotal program .

Speaker #8: Would that , you know , which I think would strain for any one of the indications might strain the ability to stay profitable .

Speaker #8: Would you be willing to go negative ? The data go to back to a loss . If the data supports it . So so or does that require a partner .

Speaker #5: Yeah . So a couple of things to remember from that perspective . Mark . If you look at our guidance for , you know , our full year in terms of net income , you know , remember that includes us paying down our debts .

Speaker #5: The debt goes away . You know mid next year . And we become a debt free company . So you start to see cash flow generation occurring because of that .

Speaker #5: Now in terms of the you know , pivotal phase three that you would need I based on the other phase threes , I've seen in this space , I'm not anticipating this to be like a 1000 patient trial or something .

Speaker #5: So I think it would still be within a manageable , you know , number . And especially given that , you know , you're not going to hit all those expenses at once , you're going to see it spaced out over time .

Speaker #5: I think it's still possible to be able to do a pivotal phase three just based on , you know , the cash flow from Neuralink's .

Speaker #5: And , you know , remaining committed to being in income positive .

Speaker #8: Okay . Thanks . It's very helpful .

Speaker #3: Thank you . And with that , this does conclude today's question and answer session . I'd like to turn the conference back to Maryann for closing remarks .

Speaker #4: Thank you for joining us today . As a reminder , this call may be accessed via replay at Puma Biotechnology Inc . Beginning later today .

Speaker #4: Have a good evening .

Speaker #3: Thank you , ladies and gentlemen , thank you for participating in today's conference call . This concludes our program . Everyone have a great day .