Q4 2023 Puma Biotechnology Inc Earnings Call
Good afternoon, My name is Alicia and I'll be your conference call. Operator today at this time all participants are in a listen only mode. After the Speakers' formal remarks, there will be a question and answer session.
Operator: Good afternoon. My name is Alicia, and I'll be your conference call operator... At this time, all participants are in a listening mode; after that, there will be a question and answer session. If you would like to ask a question... Simply press star, then the number 1 on your telephone.
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Operator: If you would like to withdraw your... And if you should require options, press. As a reminder, this call is, I would now like this conference call to go to Mary Ann, Director of IELTS.
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Speaker Change: As a reminder, this call is being recorded I would now like to turn the conference call over to Maryann or Henderson Senior director of IR for Puma Biotechnology, you may begin your conference.
Mariann Ohanesian: Thank you, Alicia. Good afternoon, and welcome to Puma's conference call to discuss our financial results for the fourth quarter of 2022. 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, and Jeff Ludwig, Chief Commercial Officer.
Maryann Henderson: Thank you Alicia.
Maryann Henderson: Good afternoon, and welcome Chip from this conference call to discuss our financial results for the fourth quarter of 2023.
Maryann Henderson: Joining me on the call today are Alan Auerbach, Chief Executive Officer, President and Chairman of the board of tumor biotechnology maximizing against Chief Financial Officer, and Jeff Ludwig Chief Commercial Officer.
Mariann Ohanesian: After the market closed today, Puma issued a news release detailing fourth quarter and full year 2023 financial results. That news release, the slides that Jeff will refer to, and a webcast of this call are accessible via the homepage and investor sessions of our website at Pumabiotechnology.com. The webcast and presentation slides will be archived on our website and available for replay for the next 90 days. Today's conference call will include statements about the company's future expectations, plans, and prospects that constitute forward-looking statements for purposes of federal securities law. Such statements are subject to risks and uncertainty, and actual events and results may differ from those expressed in these forward-looking statements. For a full discussion of these risks and uncertainties,
Maryann Henderson: After market close today Puma issued a news release detailing fourth quarter and full year 2023 financial results.
Maryann Henderson: That news release, the slides should Jeff will referred to.
Maryann Henderson: A webcast of this call are accessible via the home page and investors sections of our website at Puma Biotechnology got caught.
Maryann Henderson: The webcast and presentation slides will be archived on our website and available for replay for the next 90 days.
Maryann Henderson: Today's conference call will include statements about the company's future expectations plans and prospects that constitute forward looking statements for purposes of federal Securities laws.
Maryann Henderson: Such statements are subject to risks and uncertainties and actual events and results may differ from those expressed in these forward looking statements.
Maryann Henderson: For a full discussion of these risks and uncertainties. Please review our periodic and current reports filed with the SEC from time to time.
Mariann Ohanesian: Please review our periodic and current reports filed with the SEC from time to time. And, concluding our annual report on Form 10-K for the year ended December... Anchor WebTV NET blank channel.
Maryann Henderson: Our annual report on Form 10-K for the year ended December 31 2023.
Maryann Henderson: 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.
Alan H. Auerbach: You are cautioned not to place undue reliance on these forward-looking statements. Speak only as of the date of this live conference call, February 29, 2024. The company undertakes no obligation to revise or update any forward-looking statement after the date of this conference call, except as required by law. During today's call, we may also refer to certain non-GAAP financial measures that involve adjustments to our gaps. We believe these non-GAAP metrics may be useful to investors as a supplement to, but not a substitute for, our GAAP financing. Please refer to our fourth quarter 2023 news release for a reconciliation of our GAAP to non-GAAP results. I will now turn the call over to you.
Maryann Henderson: But we're at 29 2024.
Maryann Henderson: The company undertakes no obligation to revise or update any forward looking statements to reflect events or circumstances after the data.
Maryann Henderson: This call except as required by law.
Maryann Henderson: During today's call. We may also refer to certain non-GAAP financial measures that involve adjustments to our GAAP figures.
Maryann Henderson: We believe these non-GAAP metrics may be useful to investors as a supplement to but not as a substitute for our GAAP financial measures.
Please refer to our fourth quarter 2023 news release for a reconciliation reconciliation of our GAAP to non-GAAP results.
Maryann Henderson: I will now turn the call over to Alan.
Alan H. Auerbach: Thank you, Marianne, and thank you all for joining our call today. Today, Puma reported total revenue for the fourth quarter at $72.2 million.
Alan H. Auerbach: Thank you Mary Anne and thank you all for joining our call today.
Alan H. Auerbach: Today Puma reported total revenue for the fourth quarter.
Alan H. Auerbach: A 72.2 million.
Alan H. Auerbach: Total revenue includes product revenue, net, which consists entirely of Neuralink sales, as well as royalties from our sub-licensees. Product revenue, net, was $53.2 million in the fourth quarter of 2023, which was an increase from the Q3 2023 and slightly below. 53.7 million reported in Q4 2022. Product revenue for the fourth quarter of 2023 was impacted by approximately $2.1 million of inventory increase at all specialty pharmacies and specialty distributors. Royalty revenue was $19 million in the fourth quarter of 2023, compared to $4.5 million in Q3 of 2023 and $12 million in Q4 of 2022. We reported 2,881 bottles of Nearlink sold in the fourth quarter of 2023, essentially unchanged from the 2,874 bottles sold in Q3 of 2020. In Q4 of 23, we estimate that inventory increased by about 127 boxes. In Q4 2023, new prescriptions, or NRX, were down approximately 9% compared to Q3 2023, and total prescriptions, TRX, were down approximately 7% compared to Q3 2023. Jeff will provide further details in his comments.
Alan H. Auerbach: Total revenue includes product revenue net which consists entirely of nearly sales as well as royalties from a sub licensees.
Alan H. Auerbach: Product revenue net was $53 2 million in the fourth quarter of 2023, which was an increase from the Q3 2023 and slightly below.
Alan H. Auerbach: $53 7 million reported in Q4 2022.
Alan H. Auerbach: Product revenue for the fourth quarter of 2023 was impacted by approximately $2 1 million of inventory increase at all specialty pharmacies and specialty distributors royalty revenue was $19 million in the fourth quarter of 2023 compared to $4 5 million in Q3 of 2023 and <unk>.
Alan H. Auerbach: 8 million in Q4 of 2022.
Alan H. Auerbach: We reported 2881 bottles of nearly sold in the fourth quarter of 2023.
Alan H. Auerbach: Essentially unchanged from the 2874 bottles sold in Q3 of 2023.
Alan H. Auerbach: In Q4 of 'twenty three we estimate that inventory increased by about 127 box in Q4, 2023, new prescriptions or interacts were down approximately 9% compared to Q3 2023, and total prescriptions Trs were down approximately 7% compared to Q3 'twenty three.
Alan H. Auerbach: Jeff will provide further details in his comments and slides.
Alan H. Auerbach: They're the only sales were negatively impacted by the decline in enrollments that we mentioned in our third quarter earnings call a lower than anticipated rate of conversion from enrollment to commercial new patient starts and a higher than expected gross to net Jeff in Mexico will discuss these two topics further in.
Alan H. Auerbach: Nearly sales were negatively impacted by the decline in enrollment that we mentioned in our third quarter earnings call, a lower than anticipated rate of conversion from enrollment to commercial new patient starts, and a higher than expected gross to net. Jeff and Maximo will discuss these two topics further in their comments. We have continued to reduce our internal expenses to account for these factors as we recognize our fiscal responsibilities to the shareholders and continue to be net income positive in 2024. I will now provide a clinical review of the quarter, then Jeff Ludwig will add additional color on Neolink's commercial activities, and Maximo Nougues will follow with highlights of the key components of our financial statements for the fourth quarter of 2026.
Jeffrey Jerome Ludwig: In their comments.
Jeffrey Jerome Ludwig: We have continued to reduce our internal expenses to account for these factors as we recognize our fiscal responsibility to the shareholders and continue to be net income positive in 2024.
Speaker Change: I will now provide a clinical review of the quarter that Jeff Ludwig will add additional color on New Orleans commercial activities in Mexico, and the guests will follow with highlights of the key components of our financial statements for the fourth quarter of 2023.
In February we were pleased to announce that we initiated the alastair in cancer or Alyssa along one trial.
Alan H. Auerbach: In February, we are pleased to announce that we initiated the Alice Sertin in Cancer or ELISCA Lung 1 trial. A Phase II Clinical Trial of Allocertive Monotherapy for the treatment of patients with extensive stage small cell lung cancer. This trial was previously referred to as Study Puma-ALI-4201. The trial will enroll up to 60 patients with extensive stage small cell lung cancer who have progressed after first-line platinum-based chemotherapy and immunotherapy. Patients must provide tissue-based biopsies so that biomarkers can be analyzed. Alliserative will be dosed at 50mg BID on days 1-7 of every 21 day cycle.
Our phase II clinical trial of <unk> monotherapy.
Speaker Change: For the treatment of patients with extensive stage small cell lung cancer.
Speaker Change: This trial was previously referred to as study Puma Dash ally Dash 40 to a one.
Speaker Change: The trial will enroll up to 60 patients with extensive stage small cell lung cancer.
Speaker Change: You've progressed after first line platinum based chemotherapy and immunotherapy.
Speaker Change: Patients must provide tissue based biopsies, so that biomarkers can be analyzed.
<unk> will be dosed at 50 milligrams B I D on days, one to seven of every 21 day cycles.
Alan H. Auerbach: Puma plans to perform an initial interim analysis for the evaluation of the biomarkers as well as an evaluation of efficacy. As discussed in our last earnings call, the goal of this Phase II study will be to confirm the efficacy of allosertive monotherapy in patients with small cell lung cancer who have biomarkers where the aurora kinase pathway plays a role. The goal would be to correlate the efficacy of these biomarker subgroups in the ELISCO Lung 1 study to the efficacy that was previously seen in the biomarker subgroups from the randomized trial of paclitaxel plus alacertid versus paclitaxel plus placebo that was previously published in the Journal of Thoracic Oncology in 2012. If the efficacy and biomarker data from the two studies are comparable, the company believes it would represent a potential accelerated approval strategy and would engage FDA to discuss this further.
Speaker Change: From a player's to perform an initial interim analysis for the evaluation of the Biomarkers as well as in evaluation of efficacy.
Speaker Change: As we discussed in our last earnings call.
Speaker Change: All of this phase III study will be to confirm the efficacy of Alistair to monotherapy in patients with small cell lung cancer with Biomarkers, where the Aurora kinase pathway plays a role.
Speaker Change: The goal would be to correlate the efficacy of these biomarkers subgroups and the elliptical lung one study the efficacy that was previously seen in the biomarker subgroups from the randomized trial of Paclitaxel plus al asserted versus Paclitaxel plus placebo that was previously published in the journal of thoracic oncology in 2020.
Speaker Change: If the efficacy and biomarker data are comparable from the two studies.
Speaker Change: He believes it would represent a potential accelerated approval strategy and would engage F. D. A to discuss this further.
Speaker Change: We currently have four sites opened for enrollment and expect to have 10 to 15 sites open within the next 30 to 60 days, we anticipate that we'll be able to share interim data from this trial with investors in the second half of 2024.
Alan H. Auerbach: We currently have four sites open for enrollment and expect to have 10 to 15 sites open within the next 30 to 60 days. We anticipate that we'll be able to share interim data from this trial with investors in the second half of 2024. We also anticipate initiating ELISCA Breast 1, a Phase II trial of allosertive therapy in combination with endocrine treatment in patients with chemotherapy and I.A.V.
Speaker Change: We also anticipate the initiation of a list got breast one.
Speaker Change: A phase two trial of al assertive in combination with endocrine treatment in patients with chemotherapy naive hurts your negative hormone receptor positive breast cancer in Q4 of 2024.
Alan H. Auerbach: hurts you negative hormone receptor positive breast cancer in Q4 of 2024. We additionally anticipate two clinical data presentations on Al-Asserted in the first half of 2024. Investors will remember that the Phase II trial referred to as TBCRC-41, which was a Phase II trial of allosertive monotherapy versus L-Assertive Plus Endocrine Therapy in patients with HER2-negative, hormone receptor positive metastatic breast cancer, was published in JAMA Oncology in 2020. As part of this trial, an analysis of biomarkers was performed in order to determine if the efficacy of We anticipate that the biomarker data from this trial will be presented in the first half of 2024. In addition, there is an ongoing investigator-sponsored trial of Alicertif given in combination with Osamertini and patients with metastatic EGFR mutant non-small cell lung cancer. More specifically, patients with metastatic EGFR mutant non-small cell lung cancer are treated with osimertinib.
Speaker Change: We Additionally, anticipate two clinical data presentations on al asserted in the first half of 2024.
Speaker Change: Investors will remember that the phase two trial referred to as T. B C. R. C 41, which was a phase two trial of <unk> monotherapy.
Speaker Change: Versus Alistair plus endocrine therapy in patients with her two negative hormone receptor positive metastatic breast cancer.
Speaker Change: It was published in Jama oncology in 2023.
Speaker Change: As part of this trial and analysis of Biomarkers West performed in order to determine if the efficacy of <unk> in patients with her two negative hormone receptor positive metastatic breast cancer correlates with any biomarkers, we anticipate that the biomarker data from this trial will be presented in the first half of 2024.
Speaker Change: In addition.
There's an ongoing investigator sponsored trial of.
Speaker Change: Alistair that given in combination with <unk>.
Speaker Change: In patients with metastatic Egfr mutant non small cell lung cancer.
Speaker Change: More specifically patients with metastatic Egfr mutant non small cell lung cancer are treated with <unk> and then at the time of progression al assertive as added to Osha Merck Nib in order to see if Alistair can overcome <unk> resistance.
Alan H. Auerbach: And then at the time of progression, alisertib is added to osimertinib in order to see if alisertib can overcome osimertinib resistance. Interim data on this trial were previously presented at ASCO prior to Puma licensing the drug. We anticipate that updated data from this trial will be presented in the first half of 2024. Most notably, a recent biomarker analysis from this trial demonstrated a subgroup of patients with a biomarker where the aurora kinase pathway plays a role where alicertib appears to have much greater efficacy when added to osimertib at the time of progression on Ursa Mercury. This biomarker occurs in about half of the patients in the trial, which is consistent with the published literature on this biomarker in this patient population.
Speaker Change: Interim data on this trial previously presented at Astro prior to prove our licensing the drug.
Speaker Change: We anticipate that updated data from this trial will be presented in the first half of 2024th most notably a recent biomarker analysis from this trial has demonstrated a subgroup of patients with a biomarker, where they aurora kinase pathway plays a role or Alistair that appears to have much greater.
Speaker Change: Efficacy when attitude awesome or at the time.
Speaker Change: Off progression on or some market.
This biomarker occurs in about half of the patients in the trial, which is consistent with the published literature on this biomarker in this patient population base.
Alan H. Auerbach: Based on this biomarker data, the trial is being amended to limit enrollment in the trial to only continue enrolling patients who have this biomarker. We believe that this might represent another potential indication for Al-Assertive, and we look forward to discussing this data with investors once it has been presented publicly. As mentioned on previous earnings calls and in response to investor questions, Puma continues to evaluate several drugs to potentially end the license that would allow the company to diversify itself and leverage Puma's existing R&D, regulatory, and commercial infrastructure. The company will keep investors updated on this as it progresses. I will now turn the call over to Jeff Ludwig, Puma's Chief Commercial Officer, for a review of our commercial performance during the quarter. Hey, thanks, Alan. I appreciate it.
Speaker Change: Based on this biomarker data the trial is being amended to limit enrollment in the trial to only continue enrolling patients who have this biomarker.
Speaker Change: We believe that this might represent another potential indication for al started and we look forward to discussing this data with investors. Once it has been presented publicly.
As mentioned on previous earnings calls and in response to Investor questions from AR continues to evaluate several drugs to potentially in license that would allow the company diversify itself and leveraged promus existing R&D regulatory and commercial infrastructure. The company will keep investors updated on this as it progresses I will now turn the.
Speaker Change: The call over to Jeff Ludwig Puma, Chief Commercial officer for a review of our commercial performance during the quarter.
Jeffrey Jerome Ludwig: Okay. Thanks, Alan appreciate it and thanks to everyone for joining our fourth quarter earnings call.
Jeffrey Jerome Ludwig: And thanks to everyone for joining our fourth quarter earnings call. Before I move into the commercial review, just a reminder that I will be making forward-looking statements. Let me again start with a high-level overview of our commercial strategy, and then I will go into more detail as we discuss specific slides. From a commercial perspective, we believe that NeurLynx can benefit patients in a metastatic setting, but we remain heavily focused on early stage breast cancer. We do not have direct competition in the extended adjuvant setting and believe that there remains significant unmet need, especially for patients who are deemed to be at higher risk of reoccurrence. We want to see Neuralinks play a larger role in helping patients reduce their risk of reoccurrence and avoid metastatic disease.
Jeffrey Jerome Ludwig: Before I move into the commercial review just a reminder, that I will be making forward looking statements let.
Speaker Change: Let me again start with a high level overview of our commercial strategy and then I will go into more details as we discuss specific slides.
Speaker Change: From a commercial strategy perspective, we believe that <unk> can benefit patients in the metastatic setting, but we remain heavily focused on early stage breast cancer, we do not have direct competition in the extended adjuvant setting and believe that there remains significant unmet need, especially for patients who are deemed to be at higher risk of recurrence.
Speaker Change: We want to see <unk> play a larger role in helping patients reduce the risk of recurrence and avoid metastatic disease.
Jeffrey Jerome Ludwig: We believe Neuralink continues to be promotionally sensitive. Our sales and marketing teams are working hard to expand their reach and frequency, both with personal and non-personal promotion. HCP calls in the fourth quarter increased about 12% year over year, with about 80% of those calls being live interactions. In addition to peer call activity, we are using internal and external data to try and improve our ability to engage with clinicians at the right time, given the various treatment decisions and duration of therapy. Finally, as a commercial organization, we remain committed to being more efficient and effective with our resources. We will continue to adapt to changes in the business and the needs of the broader Puma organization.
Speaker Change: We believe <unk> continues to be promotional sensitive our sales and marketing teams are working hard to expand their reach and frequency both with personal and non personal promotion.
Speaker Change: HCP calls in the fourth quarter increased about 12% year over year with about 80% of those calls being live interactions.
Speaker Change: In addition to pure call activity, we're using internal and external data to trying to try and improve our abilities to engage with clinicians at the right time, given the various treatment decisions and duration of therapies.
Speaker Change: Finally, as a commercial organization, we remain committed to being more efficient and effective with our resources. We will continue to adapt to the changes in the business and the needs of the broader Puma organization.
Jeffrey Jerome Ludwig: Let me now transition to some of the commercial slides, where I will provide some additional specifics around performance. Once I have finished, I will turn the call over to Maximo for a more detailed review of our financial results. Turning to slide three.
Speaker Change: Let me now transition to some of the commercial slides, where I, where I will provide some additional specifics around performance. Once I have finished I will turn the call over to Maximo for a more detailed review of our financial results.
Maximo: Turning to slide three.
Jeffrey Jerome Ludwig: Slide three provides an overview of our distribution model. Now, this model has not changed and remains separated into two distinct channels, the specialty pharmacy channel and the specialty distributor channel. We do see quarterly fluctuations, but the majority of our business continues to flow through the specialty pharmacy channel. In Q4, about 74% of our business went through the specialty pharmacy channel, and the remaining 26% went through the specialty distributor channel. As a comparison, this compares to the 80% specialty pharmacy channel and 20% specialty distributed channel that we reported in Q3 of 23. Turning to slide four, Neuralink's net revenue in Q4 2023 was $53.2 million, which is a $1.6 million increase from the $51.6 million we reported in Q3 of 2023 and about a $500,000 reduction from the $53.7 million we reported in Q4 of 2022. Inventory changes will impact these comparisons, so let me provide some additional information here.
Maximo: Slide three provides an overview of our distribution model. This model has not changed and remains separated into two distinct channels, the specialty pharmacy channel and a specialty distributor channel.
Maximo: We do see quarterly fluctuations, but the majority of our business continues to flow through the specialty pharmacy channel.
Maximo: In Q4 about 74% of our business went through the specialty pharmacy channel and the remaining 26% went through the specialty distributor channel.
Maximo: As a comparison this compares to the 80% specialty pharmacy channel and 20% specialty distributor channel that we that we reported in Q3 of 'twenty three.
Maximo: Turning to slide four neuro links net revenue in Q4, 2023 was $53 2 million, which is a $1.6 million increase from the $51 6 million, we reported in Q3 of 'twenty three.
Maximo: And about a $500000 reduction from the $53 7 million, we reported in Q4 of 2022.
Maximo: Inventory changes will impact these comparisons so let me provide some additional information here.
Jeffrey Jerome Ludwig: In Q4 of 2023, we estimate that inventory increased by about 2.1 million. As a comparison, we estimate that inventory increased by about $600,000 in Q3 of 2023 and increased by about $2.6 million in Q4 of 2022. Turning to slide five, slide five shows Q4 2023 X factory bottle sales and also provides both a year over year and a quarter over quarter comparison. In Q4 of 2023, Neuralink's ex-factory bottle sales were 2,881, which represents a slight increase of about 0.2% quarter over quarter and a 13% decline year over year.
Maximo: In Q4, 2023, we estimate estimated that inventory increased by about $2 1 million.
Maximo: As a comparison, we estimate that inventory increased by about 600000 in Q3 of 'twenty three and increased by about $2 6 million in Q4 of 2022.
Maximo: Yeah.
Maximo: Turning to slide five slide five shows Q4 2023 ex factory bottle sales and also provides both a year over year and quarter over quarter comparison in.
Maximo: In Q4 of 2023 neuro links ex factory bottle sales were 2881, which represents a slight increase of about 22% quarter over quarter, and a 13% decline year over year.
Jeffrey Jerome Ludwig: Let me again provide more specifics around the inventory impact, which is also included at the bottom of the slide. We estimate that inventory increased by about 127 bottles in the fourth quarter of 2023. As a comparison, we estimate that inventory increased by about 164 bottles in Q4 of 2022 and increased by about 32 bottles in Q3 of 2023. Now, let me share some additional metrics and insights into our fourth quarter performance. In Q4, we saw new patient starts, or NRX, decline about 9% quarter over quarter and about 25% year over year. In terms of total prescriptions, or TRX, we saw about a 7% quarter-over-quarter decline and about a 17% decline year-over-year. Our SD business did grow 10% quarter over quarter and about 4% year over year. As a reminder, we do not pick up NRX or TRX data in the SD channel.
Maximo: Let me again provide more specifics around the inventory impact which is also included at the bottom of this slide.
We estimate the inventory increased by about 127 bottles in the fourth quarter of 2023.
Maximo: As a comparison, we estimate the inventory increase by about 164 bottles in Q4 2022, an increase by about 32 bottles in Q3 of 2023.
Speaker Change: Now, let me share some additional metrics and insights into our fourth quarter performance.
Speaker Change: In Q4, we saw new patient starts for <unk> declined about 9% quarter over quarter and about 25% year over year.
Speaker Change: In terms of total prescriptions or T. Rx, we saw about a 7% quarter over quarter decline and about a 17% decline year over year.
Speaker Change: Our SD business did grow 10% quarter over quarter and about 4% year over year.
Speaker Change: As a reminder, we do not pick up interacts or T Rx data and the SD channel.
Speaker Change: Overall demand decreased three 1% quarter over quarter, and about 12, 8% year over year.
Speaker Change: As Alan mentioned Q4 performance was negatively impacted by several factors first let me talk about enrollments enrollments are a very important leading indicator as they convert into new patient starts.
Jeffrey Jerome Ludwig: Overall, demand decreased 3.1% quarter over quarter and about 12.8% year over year. As Alan mentioned, Q4 performance was negatively impacted by several factors. First, let me talk about enrollment.
Speaker Change: New patient starts turned it into refills, which influence performance in subsequent quarters.
Speaker Change: Q4 performance was negative negatively impacted by the decline in enrollments. We saw in Q3 and discussed during the Q3 earnings call.
Jeffrey Jerome Ludwig: Enrollments are a very important leading indicator as they convert into new patient starts, and new patient starts turn into refills, which influence performance in subsequent quarters. Q4 performance was negatively impacted by the decline in enrollments we saw in Q3 and discussed during the Q3 earnings call.
Speaker Change: Soft Q3 enrollments had a negative impact on fourth quarter, new patient starts T Rex and overall demand.
Speaker Change: As I mentioned during the third quarter earnings call, we did see the enrollment.
Speaker Change: Enrolment trends improve as of third quarter progressed.
Speaker Change: Early in the fourth quarter, we increased the amount of H C P non personal promotion.
Jeffrey Jerome Ludwig: Soft Q3 enrollments had a negative impact on fourth quarter new patient starts, TRX, and overall demand. However, as I mentioned during the third quarter earnings call, we did see the enrollment trend improve as the third quarter progressed. Early in the fourth quarter, we increased the amount of HCP non-personal promotion.
Speaker Change: As we have discussed within with investors in prior earnings calls, we typically see a decline in enrollments in the fourth quarter as patients delay starting therapy until after the holidays.
Speaker Change: In Q4, we were pleased to see enrollments continue to improve from Q3, and we saw Q4 enrollments grow 12% sequentially. This is the first time, we've seen this growth Q4 over Q3.
Jeffrey Jerome Ludwig: As we have discussed with investors in prior earnings calls, we typically see a decline in enrollments in the fourth quarter as patients delay starting therapy until after the holidays. However, in Q4, we were pleased to see enrollments continue to improve from Q3, and we saw Q4 enrollments grow 12% sequentially. This is the first time we have seen this growth, Q4 over Q3. We are hopeful that this increase in non-personal promotion was a contributor to this enrollment growth.
Speaker Change: We are hopeful that this increase in non personal promotion was contributor to this enrolment growth. However, we're waiting on additional data before maybe before making that conclusion.
Speaker Change: The second factor that negatively impacted our Q4 performance was the conversion rate from enrollments to commercial new patient starts in Q4, we saw a decrease in the percent of patients converting from enrollments to new patient starts with the majority of that being driven by an increase in pap or free goods, we do see.
Speaker Change: Quarterly fluctuations in these conversion rates, but in Q4, we had this metric moves in a negative direction.
Jeffrey Jerome Ludwig: However, we are waiting on additional data before making that conclusion. The second factor that negatively impacted our Q4 performance was the conversion rate from enrollments to commercial new patient starts. In Q4, we saw a decrease in the percent of patients converting from enrollments to new patient starts, with the majority of that being driven by an increase in PAP or free goods. We do see quarterly fluctuations in these conversion rates, but in Q4, we had this metric move in a negative direction. Turning to slide 6, excuse me, slide 6 highlights the adoption of dose escalation since launch. We continue to believe that monitoring the adoption of dose escalation is an important metric for NeurLynx. Patients that started on a reduced dose will experience significantly lower grade 3 diarrhea and are likely to have a lower rate of discontinuation.
Speaker Change: Turning to slide five slide six Skus me slide six highlights the adoption of dose Escalations since launch we continue to believe that monitoring the adoption of dose escalation is an important metric for neuro links.
Speaker Change: Patients that started to reduce dose well experienced significantly lower grade three diarrhea and are likely to have a lower rate of discontinuation.
Speaker Change: In Q4, approximately 76% of patients who receive commercial drug started in early on a lower daily dose.
Speaker Change: We have seen a fairly steady increase in the adoption of dose escalation over the last several years and I am pleased with the feedback that we received from customers.
Speaker Change: Slide seven highlights the collaborations we have formed across the globe I have highlighted in red a number of updates since our Q3 earnings call. We are pleased to announce that in late Q3, <unk> received regulatory approval in Mexico in the metastatic setting and also received regulatory approval in the United Arab Emirates in the.
Speaker Change: In adjuvant setting.
Speaker Change: In addition in Q1, New Orleans recently received regulatory approval in Syria in the extended adjuvant setting and was officially launched in Morocco also in the extended adjuvant setting.
Jeffrey Jerome Ludwig: In Q4, approximately 76% of patients who received commercial drugs started Neuralinks on a lower daily dose. We have seen a fairly steady increase in the adoption of dose escalation over the last several years, and I am pleased with the feedback that we receive from customers. Slide seven highlights the collaborations we have formed across the globe. I have highlighted in red a number of updates since our Q3 earnings call. We are pleased to announce that in late Q3, NeurLynx received regulatory approval in Mexico in the metastatic setting and also received regulatory approval in the United Arab Emirates in the extended adjuvant setting. In addition, in Q1, Neuralink recently received regulatory approval in Syria in the extended adjuvant setting and was officially launched in Morocco, also in the extended adjuvant setting.
Speaker Change: We truly appreciate all the efforts put forth by our partners to make <unk> available to more patients around the world.
Speaker Change: I'd like to wrap up by thanking my colleagues at Puma for their passion and dedication to making an impact on the lives of patients and their families. Battling cancer. This team is committed to finding ways to be more efficient and effective and adapting to the changing needs of the business I will now turn the call over to Maximo for a review of our full financial results.
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Maximo: Thanks, Jeff.
Maximo: We will begin with a brief summary of our financial results for the fourth quarter of 2023.
Maximo: Please note that I will make comparisons to Q3 2023.
Maximo: We believe is a better indication of our progress as a commercial company than year over year comparisons.
Maximo: More information I recommend that you refer to our 2023 okay.
Jeffrey Jerome Ludwig: We truly appreciate all the efforts put forth by our partners to make Neuralinks available to more patients around the world. I'd like to wrap up by thanking my colleagues at Puma for their passion and dedication to making an impact on the lives of patients and their families battling cancer. This team is committed to finding ways to be more efficient and effective in adapting to the changing needs of the business. I will now turn the call over to Maximo for a review of our full financial results. Maximo?
Maximo: We filed today and includes our consolidated financial statements.
Maximo: The fourth quarter of 'twenty to 'twenty, three we reported net income based on GAAP $12 3 million or.
Maximo: <unk> 26 per share.
Maximo: This compares to net income in Q3, 2023, or $5 8 million or 12 cents per share.
Maximo: And a non-GAAP basis, which is adjusted to remove the impact of stock based compensation expense.
Maximo: Importantly, net income of $14 8 million or 31 cents per share for the fourth quarter of 2023.
Maximo F. Nougues: Thanks, Jeff. I will begin with a brief summary of our financial results for the fourth quarter of 2023. Please note that I will make a comparison to Q3 2023, which we believe is a better indication of our progress as a commercial company than year-over-year comparisons. For more information, I recommend that you refer to our 2023 10-K, which will be filed today and includes our consolidated financial statements. In the fourth quarter of 2023, we report a net income based on cap. 12.3 million, for $0.26 per share.
Maximo: Whereas revenue from Nellix sales was $64 9 million in Q4 2023.
Maximo: $64 million in Q3 2023.
Maximo: So Alan mentioned that they are proud of the revenue cross selling sales was $53 2 million an increase of $51 6 million reported in Q3 2023.
Q4, net sales were impacted by lower enrollments in Q3 as well as a higher gross to net in Q4.
Maximo: Inventory buildup by our distributors was approximately $2 1 million in Q4, which was normally unexpected.
Maximo: This was approximately <unk> 6 million of a buildup in Q3 2023.
Maximo F. Nougues: This compares to net income in Q3 2023 of 5.8 million, or 12 cents per share, on a non-gap basis, which is adjusted to remove the impact of stock-based compensation expense. We reported net income of $14.8 million, or $0.31 per share, for the fourth quarter of 2020. Gross revenue from Merlin sales was $64.9 million in Q4 2023 and $60.4 million in Q3 2020. As Alan mentioned, net product revenue from nailing cells was $53.2 million, an increase from the $51.6 million reported in Q3 2020. Q4 net sales were impacted by lower enrollments in Q3, as well as a higher gross-to-net in Q4.
Maximo: Oh, Iot revenue totaled $19 million in the fourth quarter of 2023.
Maximo: Compared to $4 5 million in Q3 2023.
Maximo: Higher royalties versus Q3 versus Q3, reflecting the timing of shipments to our partner in China.
Maximo: As we noted last quarter.
Maximo: Our gross to net adjustment in Q4, 'twenty to 'twenty, three plus about 18, 1% compared to the 14, 6% and gross to net adjustment recorded in Q3 2023.
Maximo: Higher Medicaid share, particularly from patients in Puerto Rico.
Speaker Change: Got it and then charged Sparks were the main drivers of the increase versus Q3 2023.
Speaker Change: Cost of sales for Q4, 2023 was $24 3 million.
Speaker Change: Including $2 4 million for amortization of intangible assets related to our <unk> license.
Speaker Change: Cost of sales for Q3, 2023 was $13 3 million.
Speaker Change: Going forward, we will continue to recognize amortization of the milestone the licensor of about $2 4 million per quarter as cost of sales.
Maximo F. Nougues: Inventory buildup by our distributors was approximately 2.1 million in Q4, which was lower than expected, versus approximately 0.6 million of build-up in Q3 2020. Royalty revenue totaled $19 million in the fourth quarter of 2023, compared to $4.5 million in Q3 2020. Higher royalties versus Q3 reflect the timing of shipments to our partner in China, as we noted last quarter. Our gross net adjustment in Q4 2023 was about 18.1%, compared to the 14.6% gross net adjustment reported in Q3 2023. Higher Medicaid share, particularly from patients in Puerto Rico, and higher government charges SPACs were the main drivers of the increase versus Q3 2020.
Speaker Change: Our fiscal year 'twenty to 'twenty four.
Speaker Change: Anticipate net nellix part of revenue will be in the range of 183 to 190 million.
Speaker Change: We also anticipate that our gross to net adjustment for the full year 'twenty 'twenty four will be between 21, 5% and 22, 5%.
Speaker Change: And by the inflation reduction act and higher expected Medicaid rebates.
Speaker Change: In addition, four.
Speaker Change: Fiscal year 'twenty 'twenty, four we anticipate receiving royalties from our partners around the world in the range of 30% to $33 million.
Speaker Change: We expect license revenue in 2024 in the range of one to 2 million.
Speaker Change: We also expect our net income for the full year will be in the range of 12 to 15 million.
We anticipate that for Q1, 'twenty 'twenty four Netflix product revenue net will be in the range of $38 million to $40 million.
Maximo F. Nougues: Kaftos sales for Q4 2023 were $24.3 million, including $2.4 million for the amortization of intangible assets related to our neratinib line. Top 2 sales for Q3 2023 were 13.3 million. Going forward, we will continue to recognize amortization of milestones to the licensure of about $2.4 million per quarter as cost of service. For fiscal year 2024, Puma anticipates that Net NetLynx product revenue will be in the range of 183 to 190 million. We also anticipate that our gross net adjustment for the full year 2024 will be between 21.5% and 22.5%, driven by the Inflation Reduction Act and higher expected Medicaid revenues.
Speaker Change: Also we expect Q1 royalty revenues will be in the range of two $5 million to $3 million.
Speaker Change: No license revenue.
Speaker Change: We further estimate that the gross to net adjustment in Q1, 'twenty 'twenty four will be approximately 23% to 24%.
Speaker Change: Puma anticipates, a Q1 net loss of 10.
Speaker Change: Between 10 and.
Speaker Change: 12 million sorry, let me repeat that Puma anticipates, a Q1 net loss between 10 and $12 million.
Speaker Change: As investors are aware.
Q1, usually represent the lowest net product revenue of the fourth quarter due to the burn off.
Speaker Change: Inventory build from Q4.
Speaker Change: Also due to our litigation expense and a one time all incentive expense, we expect higher expenses in Q1 and other quarters in 2024.
Speaker Change: Due to those items.
Maximo F. Nougues: For fiscal year 2024, we anticipate receiving royalties from our partners around the world in the range of $30 to $33 million. We expect licensed revenue in 2024 in the range of $1 to $2 million. We also expect that net income for the full year will be in the range of $12 to $15 million. We anticipate that for Q1 2024, Nanolix product revenue net will be in the range of $38 to $40 million.
Speaker Change: Cash and a net loss in Q1, but anticipate that we will be net income positive for the reminder of 2024 as well as for the full year.
Speaker Change: SG&A expenses were $20 2 million in the fourth quarter of 2023 compared to $22 8 million for the third quarter.
Speaker Change: SG&A expenses included a noncash.
Speaker Change: Charges for stock based compensation of $1 8 million for Q4 2023 unchanged from Q3 2023.
Speaker Change: Research and development expenses were $12 9 million in the fourth quarter of 2023 compared to $11 4 million from the third quarter.
Maximo F. Nougues: Also, we expect Q1 royalty revenues to be in the range of $2.5 to $3 million, and No License revenue. We further estimate that the gross net adjustment in Q1 2024 will be approximately 23% to 24%. Puma anticipates a Q1 net loss of $10, between $10M and $12M. Puma anticipates a Q1 net loss between $10M and $12M. As investors are aware, Q1 usually represents the lowest net product revenue of the fourth quarter due to the burn-off from Inventory Build from Q4.
Speaker Change: R&D expenses included noncash charges for stock based compensation of zero point $8 million in the fourth quarter of 2023.
Speaker Change: Changed from the third quarter.
Speaker Change: On the expense side, Puma anticipates flat total operating expenses in 2024 compared to 2023.
Speaker Change: More specifically, we anticipate SG&A expenses to decrease by 8% to 12%.
Speaker Change: <unk> expenses to increase 17% to 20% year over year.
Maximo F. Nougues: Also, due to our litigation expense and a one-time acquisition expense, we expect higher expenses in Q1 than other quarters in 2024. Due to those items, we are forecasting a net loss in Q1, but anticipate that we will be net income positive for the remainder of 2024, as well as for the full year. SG&A expenses were $20.2 million in the fourth quarter of 2023 compared to $22.8 million for the third quarter.
Speaker Change: Due to our litigation expenses, we expect G&A expenses in Q1 and Q2.
Speaker Change: Significantly higher than Q3 and Q4.
Speaker Change: In the fourth quarter of 2023.
Speaker Change: From a reported cost.
Speaker Change: Approximately $10 4 million.
This compares to cash earn of approximately $10 6 million in Q3 2023.
Speaker Change: For the full year Puma reported cash burn of approximately $14 4 million.
Speaker Change: 2023 we made a $12 5 million payment for a sales milestone to Pfizer and an $8 million settlement payment as well.
Maximo F. Nougues: LGA expenses included non-cash charges for stock-based compensation of $1.8 million for Q4 2023, unchanged from Q3 2023. Research and development expenses were $12.9 million in the fourth quarter of 2023 compared to $11.4 million for the third quarter. The expenses included non-cash charges for stock-based compensation of $0.8 million in the fourth quarter of 2023, a change from the third quarter. On the expense side, Puma anticipates flat total operating expenses in 2024 compared to 2022. More specifically, we anticipate SG&A expenses to decrease by 8% to 12% and R&D expenses to increase 17% to 20% year-over-year.
Speaker Change: At December 31st 2023, we had approximately $96 million in cash.
Speaker Change: Cash equivalents and marketable securities versus any 1 million a year earlier.
Speaker Change: Our accounts receivables balance was $47 8 million.
Speaker Change: Our accounts receivable terms range between 10 and 68 days.
Speaker Change: Our days sales outstanding sorry about 46 days.
Speaker Change: We estimate that as of December 31st 2023, our distribution therefore maintain approximately three weeks of inventory.
Speaker Change: Overall, we continue to deploy it over from natural resources to focus on the commercialization of neural links the develop of our lives.
Speaker Change: The development of all incentive and controlling our expenses.
Speaker Change: Thanks Massimo.
Speaker Change: We are pleased to report positive net income for the fourth quarter of 2023 and for full year 2023.
Maximo F. Nougues: Due to our litigation expenses, we expect G&A expenses in Q1 and Q2 to be significantly higher than Q3 and Q4. Puma reported a cost of earnings of approximately $10.4 million. This compares to a cash earn of approximately $10.6 million in Q3 2020. For a full year, Puma reported a cash earn of approximately $14.4 million.
Speaker Change: Puma Senior management in cooperation with the board of Directors continues to remain focused on nearly sales trends in 2024 and beyond and recognized in this fiscal responsibility to shareholders to continue to maintain positive net income.
Speaker Change: Fourth quarter of 2021, we implemented a reduction in expenses.
Maximo F. Nougues: In 2023, we made a 12.5 million payment for a sales milestone to Pfizer and an $8 million settlement payment as well. On December 31st, 2023, we had approximately 96 million in cash, cash equivalents, and marketable security, persisting $81 million a year. Our account receivables balance was $47.8 million.
Speaker Change: With the goal of reducing expenses in order to maximize operational cash flows. We believe that the positive net income reported in the fourth quarter and for the full year 2023 reflects these expense reductions.
Speaker Change: Expense reductions that we have previously performed and continue to perform are also a major contributor to the positive net income.
Speaker Change: Company is guiding to for full year 2024.
Speaker Change: 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 F. Nougues: Our accounts receivable terms range between 10 and 68 days, while our day sales outstandings are about 46 days. We estimate that as of December 31, 2023, our distribution network will maintain approximately three weeks of inventory. Overall, we continue to deploy our financial resources to focus on the commercialization of NeurLynx, the development of Alicertive, and controlling our expenses. Thanks, Maximo. We are pleased to report positive net income for the fourth quarter of 2023 and for the full year 2023. Puma Senior Management, in cooperation with the Board of Directors, continues to remain focused on near-link sales trends in 2024 and beyond, and recognizes its fiscal responsibility to shareholders to continue to maintain positive net income.
Speaker Change: There continues to remain a significant unmet need for patients battling breast cancer lung cancer and other solid tumors. We have 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.
Speaker Change: This concludes today's presentation, we will now turn the call back to the operator for Q&A operator.
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.
Speaker Change: Confirmation tone will indicate your line is in the question queue.
Operator: Thank you Mr <unk>.
Speaker Change: Are all your request please press star two.
Operator: For participants using speaker equipment it may.
Operator: To be necessary to pick up your handset before pressing the snarky.
Alan H. Auerbach: In the fourth quarter of 2021, we implemented a reduction in expenditures with the goal of reducing expenses in order to maximize operational cash. We believe that the positive net income reported in the fourth quarter and for the full year 2023 reflects these expense reductions. 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 is guiding to for full year 2024. The company remains committed to continuing to achieve this positive net income and will continue to reduce expenses if needed to achieve it.
Operator: One moment, please while we poll for questions.
Speaker Change: Your first question comes from the line of.
Raul with TD Cowen. Please proceed with your question.
Raul: Hi, guys congrats on the quarter I This is mark.
Speaker Change: So.
I had a few questions on the phase two trial in small cell lung cancer.
Raul: One would be I guess in terms of the second half days disclosure should we expect it could be at a medical meeting or do you think it could be a press release and then my second question.
Raul: I know you mentioned that the biomarker data was going to be one of the metrics that you have.
Raul: From the interim analysis to determine whether you.
Alan H. Auerbach: We look forward to updating investors on this in the future. It continues to remain a significant unmet need for patients battling breast cancer, lung cancer, and other solid tumors. We at Puma are committed and passionate about finding more effective ways of helping these patients during their journey, and we will continue to strive to achieve that goal. This concludes today's presentation. We will now turn the call back to the operator for Q&A. Operator?
Raul: Move forward, we're talking with the FDA.
Raul: Hum.
Raul: All of her good combo trial with Paclitaxel also the best bar to look at when you are looking at efficacy and you feel like you want to see both the biomarker and the efficacy data kind of lineup with that trial before moving forward with that.
Speaker Change: Oh, no I shouldn't say discussion thanks.
Speaker Change: Yeah. So David Thank you for your question in terms of the disclosure Ah I would imagine it would be something more direct to investors are not at a medical meeting because just presented medical need and you have to submit an abstract in there's a lead time, there and I'm not sure how much data, where you would have to submit to a medical meeting so medical.
Operator: Thank you. We will now begin the question and answer session. If you wish to ask... Please press star 1 on your telephone keypad, a confirmation. Indicate your line is.
Operator: If you wish to withdraw your request, please press... Participants, you may now disconnect. It may be necessary to pick up your handset before pressing the start button.
Speaker Change: Meeting presentation, I would guess probably had more of a 2025 event, but you know presenting that in some way shape or form to investors that that would be the way. We would do this and obviously you know as much detail as we can you know.
Operator: One moment, please, while we... Divya Rao. Hi guys, congrats on the quarter. This is Divya author Mark. So, I had a few questions on the phase two trial in small cell lung cancer. One would be, I guess, in terms of the second half of the disclosure, should we expect it to be at a medical meeting? Or do you think it could be a press release?
Speaker Change: As we mentioned, we're gonna be greatly increasing the number of sites. This.
Speaker Change: This month and so we're anticipating we're going to have a good number of patients to talk about.
Divya Rao: And then my second question is, I know you mentioned that the biomarker data was going to be one of the metrics that you use from the interim analysis to determine whether you move forward with talking with the FDA. Is the allosertive combo trial with paclitaxel also the best bar to look at when you're looking at efficacy? And do you feel like you want to see both the biomarker and the efficacy data kind of line up with that trial before moving forward with the FDA for future discussion? Yeah, so Divya, thank you for your question.
Speaker Change: In terms of your second question so.
Obviously in small cell lung cancer, you have both the hemophilia therapy sensitive group and the chemotherapy refractory group are the resistant group. So you've got kind of two different it's not it's not totally homogeneous I don't know that like cross trial comparison is gonna be like compared to this trial of that because it gets a little tricky in terms of prior treatments and things like that.
I think the clear signal that we're looking for is both response rate and PFS, but to see something that's better in the group that has the biomarker then does it from from the early data because again you know.
Alan H. Auerbach: In terms of the disclosure, I would imagine it would be something more direct to investors, not at a medical meeting, because, you know, to present at a medical meeting, you have to submit an abstract, and there's a lead time there. And I'm not sure how much data we would have to submit to a medical meeting. So a medical meeting presentation, I would guess probably more of a 2025 event. But you know, presenting that in some way, shape, or form to investors, that would be the way we would do this. And obviously, you know, as much detail as we can. As we mentioned, we're going to be greatly increasing the number of sites this month. And so, you know, we're anticipating we're going to have a good number of patients to talk to. In terms of your second question, so, you know, obviously, in small cell lung cancer, you have both the chemotherapy-sensitive group and the chemotherapy refractory group or the resistant group, so you kind of have two different groups; it's not, you know, it's not totally homogeneous.
Speaker Change: The thesis we have.
Speaker Change: Is that.
Speaker Change: Alistair did is in Aurora, a kinase inhibitor. So the biomarkers that are involved in the Aurora kinase pathway is where we should see the best efficacy.
Speaker Change: That's really the signal we want to confirm.
Speaker Change: Cause of different numbers and things like that are not quite sure. If we're going to want to do cross trial comparisons quite yet but in terms of their early data that's really what we're gonna be looking for is to see you know is there a biomarker subgroup that selects for the patients who are most likely to benefit from the drug.
Speaker Change: Got it that's helpful. Thank you.
Speaker Change: Okay.
Speaker Change: Thank you.
Speaker Change: Our next question comes from the line of.
Speaker Change: Please proceed with your question.
Speaker Change: Hi, good afternoon. Thanks for taking our questions. This is proceed on for Gena.
I had a couple on outside that Alan you touched on this a little bit in the previous question.
Gena: But I kind of wanted to get some more color on what the efficacy bar with people who are very good in the small cell trial and and I understand you disclosed that you don't want to make cross trial comparisons, but any color you can shed on how youre thinking about outside of that especially in light of you know the DLL three targeting <unk>.
Alan H. Auerbach: I don't know that, like, cross-trial comparison is going to be, like, compared to this trial or that, because it gets a little tricky in terms of prior treatments and things like that. I think the clear signal we're looking for is both, you know, response rate and PFS, but to see something that's better in the group that has the biomarkers than doesn't, from the early data. Because, again, you know, The thesis we have is that L-Assertive is an auroral kinase inhibitor, so the biomarkers that are involved in the auroral kinase pathway are where we should see the best efficacy. That's really the signal we want to confirm. Because of different numbers and things like that, I'm not quite sure if we're going to want to do cross-trial comparisons quite yet, but in terms of the early data, that's really what we're going to be looking for, is there a biomarker subgroup that selects for the patients who are most likely to benefit from the drug?
Gena: <unk> in development, including Amgen Mab that has a pretty for later this year and you know harpoons tray pack.
Gena: Got taken over by Merck.
Gena: So in some early.
Gena: So just keeping things in the background.
Gena: Curious if you could shed some color on how youre thinking about it.
Speaker Change: Yeah, so with reference to the deal all three drugs you know Charles <unk> with a third line drug so challenging from that perspective to try to compare a second line third line also I would say that while I recognize response rate as the typical thing people like to do cross trial comparisons on.
Speaker Change: As you're aware you can't just get approval on response rate E. They actually show a magnitude of that benefit so a PFS or survival benefit. So I think all of those are going to be important for us to look at there is data analysis as a mono therapy that was published in lancet oncology previously.
Alan H. Auerbach: Got it. That's helpful. Thank you. Hi, good afternoon. Thanks for taking your questions. This is Harshita on behalf of Gina.
Harshita Polishetty: I had a couple on Alicerta and Alan. You touched on this a little bit in the previous question. But I kind of wanted to get some more color on what the efficacy bar would be for ALICE-RDAP in the small cell trial, and I understand you disclosed that you don't want to make, you know, cross-trial comparisons, but any color you can shed on how you're thinking about ALICE-RDAP, especially in light of, you know, the DLL3 targeting agents that are in development, including, you know, Amgen They had shown some early, you know, results and saved one. So I'm just keeping this in the background. I was curious if you could shed some light on how you're thinking about outsourcing. www.mustwatch.eu Yeah, so with reference to the DLL-3 drugs, you know, tarlatumab was a third-line drug. So, you know, challenging from that perspective to try to compare a second line and a third line.
Speaker Change: And off the top of my head to remembering it was like a 20% response rate and a somewhere around three months PFS and a non selected group.
Speaker Change: So that that would kind of be the most the only data we have for alister to them as a single agent. If you will but trying to compare it to other agents, especially just looking at response rate.
Speaker Change: In small cell lung cancer. Unfortunately, you've seen lots of drugs that have got really high response rate, but they can't confirm their clinical benefits because of no increase in PFS or OS.
Speaker Change: I think again, it's going to be really a totality of data, where we want to see a response rate improvement of PFS improvement.
Speaker Change: And the PFS in the U S.
Speaker Change: Obviously, they're going to be the ones going to be more important to us.
Speaker Change: Got it. Thank you Alan that's helpful. And then just a quick question again on outside that have you disclosed what the exact oil depressing to get your take or pay type.
Alan H. Auerbach: Also, I would say that, you know, while I recognize response rate is the typical thing people like to do cross-trial comparisons on, you know, as you're aware, you can't just get approval on response rate. You need to actually show the magnitude of that benefit, so a PFS or survival benefit. So I think all of those are going to be important for us to look at. You know, there is data on alicertib as a monotherapy that was published in Lancet Oncology previously, and I'm off the top of my head remembering it was like a 20-ish percent response rate and somewhere around three-month PFS in a non-selected group. So, you know, that would kind of be the most, you know, the only data we have for alicertib as a single agent, if you will. But trying to compare it to other agents, especially just looking at response rates, you know, in small cell lung cancer, unfortunately, you've seen lots of drugs that have got really high response rates, but they can't confirm their clinical benefits because of no increase in PFS or OS.
Speaker Change: The products are commercialized.
Alan H. Auerbach: I do not have that in front of me in terms of our public disclosure.
Alan H. Auerbach: My recollection is we said something in the single digit range, if I remember correctly.
Speaker Change: Got it helpful. Thank you so much.
Speaker Change: Okay.
Speaker Change: Yeah.
Speaker Change: Thank you.
Speaker Change: There are no further questions at this time I would like to turn the conference back over to Mary Anne for closing comments.
Mary Anne: Thank you all for joining us today.
Mary Anne: Mind you this call may be accessed via replay of the webcast.
Biotechnology Dot com beginning later today.
Mary Anne: Good evening.
Mary Anne: Ladies and gentlemen, thank you for participating in today's conference call.
Speaker Change: Our program everyone have a great day, you may now disconnect.
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Alan H. Auerbach: So I think, again, it's going to be a totality of data where we want to see a response rate improvement, a PFS improvement. And the PFS and the OS, obviously, are going to be the ones that are going to be more important. Got it. Thank you, Alan. That's helpful. And then just a quick question again on our sort of what are the exact royalty percentages you owe to Takeda if the products approved are commercialized? I do not have that in front of me in terms of our public disclosure. My recollection is we said something in the single digit range, if I remember correctly.
Speaker Change: Okay.
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Alan H. Auerbach: Got it. Helpful. Thank you. There are no.
Speaker Change:
Operator: Thank you for your time. I would like to... Thank you all for joining us. As a reminder, this call may be accessed via replay of the webcast, which got began later today.
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Operator: Have a good evening now. Subs by www.zeoranger.co.uk. Transcript Emily Beynon BF-WATCH TV 2021. Thanks for watching! Bye! www.thevenusproject.com www.globalonenessproject.org BF-WATCH TV 2021, The Ultimate Parody Site! BF-WATCH TV 2021, transcript Emily Beynon www.mytrendyphone.co.uk BF-WATCH TV 2021, The Bulletproof Executive 2013, Subscribe to our channel for more videos on Cisco training with GNS3!
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Operator: The Ultimate Parody Site! Title Microsoft Office Word Document MSWordDoc Word. Document.8, The Bulletproof Executive 2013 BF-WATCH TV 2021, www.microsoft.com.ca www.globalonenessproject.org, transcript Emily Beynon
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