Q3 2024 Puma Biotechnology Inc Earnings Call
One on your telephone keypad.
If you would like to withdraw your question. Please press star two.
[music]
If you should require operator assistance during the conference. Please press Star zero.
As a reminder, this call is being recorded.
Speaker Change: I would now like to turn the conference over to Marianne.
Marianne: Oh, Hannesson senior director of Investor Relations for Puma Biotechnology, you may begin your conference.
Speaker Change: Thank you Rob good afternoon and welcome.
Speaker Change: Oh, that's our financial results for third quarter of 'twenty 'twenty four joining.
Speaker Change: Joining me on the call today are Alan Auerbach, Chief Executive Officer, President and Chairman of the board its been a biotechnology next pneumonia guests Chief Financial Officer, and she has to Ludwig Chief Commercial officer.
Animated by Jeremy Sartorial Alan Auerbach
Speaker Change: After market close today Puma issued a news release.
Speaker Change: Thank you for joining us for today's conference. Our conference will be beginning shortly. Once again, thank you for joining us today. Your conference will begin shortly. Thank you.
Results for the third quarter of 2024.
Speaker Change: That news release, the slides that Jeff will referred to and a webcast of this call are accessible via the home age and investor sections of our website and Puma Biotechnology got caught the webcast and presentation slides will be archived on our website and available for replay for the next 90 days.
[music]
Speaker Change: Today's conference call will include statements about whom its future expectations plans and prospects that constitute forward looking statements for purposes of federal Securities laws.
Speaker Change: Statements are subject to risks and uncertainties and actual events and results may differ from those expressed in these forward looking statements.
Speaker Change: 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 31 2023.
The
Speaker Change: You are cautioned not to place undue reliance on these forward looking statements, which which speak only as of the date of this live conference call November seven 2024.
Speaker Change: Undertakes no obligation to revise or update any forward looking statements to reflect events or circumstances. After the date of this call except as required by law.
Speaker Change: During today's call, we may refer to certain non-GAAP financial measures that involve adjustments to GAAP figures.
Speaker Change: We believe these non-GAAP metrics may be useful to investors as a supplement to but not as substitute for our GAAP financial measures.
Thanks for watching!
Please refer to our third quarter 2024 news release for a reconciliation of our GAAP to non-GAAP results I will now turn the call over to Alan.
Alan Auerbach: Thank you Mary Anne and thank you all for joining our call today.
Today Puma reported.
Rob: Good afternoon. My name is Rob and I'll be your conference call operator today.
Total revenue for the third quarter of 2024 of $80 5 million.
At this time, all participants are in listen-only mode.
Total revenue includes product revenue net which consists entirely of narrowing sales as well as royalties from our sub license seats.
Rob: After the speaker's formal remarks, there will be a question and answer session.
Rob: If you would like to ask a question during that time, simply press the star key, then the number 1 on your telephone keypad. If you would like to withdraw your questions, please press star 2. If you should require operator assistance during the conference, please press star 0.
Alan Auerbach: Product revenue net was $56 1 million in the third quarter of 2024, which was an increase from both the $44 4 million reported in Q2, 2024, and $51 6 million reported in Q3 2023.
As a reminder, this call is being recorded.
Speaker Change: I would now like to turn the conference over to Mariann Ohanesian, Senior Director of Investor Relations for Puma Biotechnology. You may begin your conference.
Alan Auerbach: Product revenue for the third quarter of 2024 was impacted by approximately zero point $6 million of inventory increase at our specialty pharmacies and specialty distributors.
Mariann Ohanesian: Thank you, Rob. Good afternoon and welcome to PUMA's conference call to discuss our financial results for third quarter of 2024.
Alan Auerbach: Royalty revenue was $24 4 million in the third quarter of 2024 compared to $2 7 million in Q2, 2024, and $4 5 million in Q3 of 2023 royalty revenue in the latest quarter included the expected sales to China by our offshore partner Pierre Fabre.
Mariann Ohanesian: 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.
Mariann Ohanesian: After market closed today, PUMA issued a news release detailing the earnings results for the third quarter of 2024.
Alan Auerbach: As we noted in our August forecast of Q3 2024 results.
Alan Auerbach: We reported 2723 bottles of <unk> sold in the third quarter of 2024.
Alan Auerbach: An increase.
Alan Auerbach: Of 208 from the 2000 and 515 bottle sold in Q2 2024 in.
Mariann Ohanesian: The webcast and presentation slides will be archived on our website and available for replay for the next 90 days.
Alan Auerbach: In Q3 to 24, we estimate that inventory increased by about 37 bottles in Q3 2024, new prescriptions were up 3% compared to Q2 2024, and total prescriptions were essentially flat compared to Q2 2020 for Jeff.
Mariann Ohanesian: Today's conference call will include statements about PUMA's future expectations, plans and prospects that constitute forward-looking statements for purposes of federal security laws.
Mariann Ohanesian: Such statements are subject to risks and uncertainties, and actually advanced results may differ from those expressed in these forward-looking statements.
Speaker Change: Jeff will provide further details in his comments and slides.
Mariann Ohanesian: 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 31, 2023.
Speaker Change: I will now provide a clinical review of the quarter.
Speaker Change: And then Jeff Ludwig will address or additional color on <unk> commercial activities.
Maximo <unk> will then follow with highlights of the key components of our financial statements for the third quarter of 2024.
Mariann Ohanesian: You are cautioned not to place any reliance on these forward-looking statements, which speak only as of the date of this live conference call, November 7, 2024.
Speaker Change: Yeah.
As previously discussed.
<unk> has an ongoing phase II study of our investigational drug <unk> to confirm the efficacy of <unk> monotherapy in patients with small cell lung cancer with Biomarkers, where they Aurora kinase pathway plays a role.
Mariann Ohanesian: SUMA undertakes no obligation to revise or update any forward listen statements to reflect events or circumstances after the date of this call, except as required by law.
Speaker Change: Goal is to correlate the efficacy in these biomarker subgroups in the <unk> one study to the efficacy that was previously seen in the biomarker subgroups from the randomized trial of Paclitaxel plus <unk>.
Mariann Ohanesian: During today's call, we may refer to certain non-GAAP financial measures that involve adjustments to our GAAP figures. We believe these non-GAAP metrics may be useful to investors as a supplement to, but not a substitute for, our GAAP financial measures.
Versus Paclitaxel plus placebo that was published in the journal of thoracic oncology in 2020.
Speaker Change: Please refer to our 3rd quarter 2024 news release for reconciliation of our GAP to non-GAP results. I will now turn the call over to Alan.
Speaker Change: If the efficacy and biomarker data are comparable from the two studies. The company believes it would represent a potential accelerated approval strategy and will engage FDA to discuss this further.
Alan Auerbach: Thank you, Mariann, and thank you all for joining our call today.
Alan Auerbach: Today, PUMA reported total revenue for the third quarter of 2024 of $80.5 million.
Speaker Change: As investors will remember Alex <unk> was previously tested as a monotherapy in patients with small cell lung cancer and the results of this trial were published in lancet oncology in 2015.
Alan Auerbach: Total revenue includes product revenue net, which consists entirely of Neuralink sales.
Speaker Change: In this trial <unk> was administered as a monotherapy to patients with small cell lung cancer.
as well as royalties from our sub-licensees.
Alan Auerbach: Product revenue net was $56.1 million in the third quarter of 2024, which was an increase from both the $44.4 million reported in Q2 2024 and the $51.6 million reported in Q3 2023.
The safety results and equal 60 from the trial.
Speaker Change: Showed that 37% of the patients experienced grade three or four neutropenia, 7% experienced grade three four drug related febrile neutropenia, and 22% of the patients discontinued treatment due to adverse events.
Alan Auerbach: Product revenue for the third quarter of 2024 was impacted by approximately 0.6 million of inventory increase at our specialty pharmacies and specialty distributors.
Speaker Change: The results from an efficacy evaluable population of 48 patients showed that for the 36 chemotherapy sensitive patients. The objective response rate was 19% and the PFS was $2 six months and for the 12 chemotherapy resistant or relapsed patients.
Alan Auerbach: Royalty revenue was $24.4 million in the third quarter of 2024 compared to $2.7 million in Q2 2024 and $4.5 million in Q3 2023.
Speaker Change: The objective response rate was 25% with a PFS of one seven months.
As investors are also remember <unk> was also previously tested in a randomized phase III trial of Paclitaxel, plus <unk> versus Paclitaxel plus placebo in patients with second line small cell lung cancer, which was published in the journal of thoracic oncology in 2012.
Alan Auerbach: Royalty revenue in the latest quarter included the expected sales to China by our offshore partner Pierre Farb.
Alan Auerbach: As we noted in our August forecast of Q3 2024 results.
Alan Auerbach: We reported 2,723 bottles of Neuralink sold in the third quarter of 2024.
Speaker Change: Alistair was dosed at a different dose than in the monotherapy trial with all sort of being administered at 40 milligrams PID for three weeks and days one to three 8% to 10% and 15 to 17, plus Paclitaxel 60, Megs intravenously on days, one eight and 15, whereas the comparator arm receive placebo.
and increase
of 208 from the 2,515 bottles sold in Q2 2024.
Alan Auerbach: In Q3-24, we estimate that inventory increased by about 37 bottles.
Alan Auerbach: In Q3 2024 new prescriptions were up 3% compared to Q2 2024 and total prescriptions were essentially flat compared to Q2 2024.
Speaker Change: <unk> plus Paclitaxel 80 milligrams per meter squared IV on days, one eight and 15 in 28 day cycles.
While also incorporated an extensive biomarker analysis with a prespecified analysis of <unk> expression as well as a retrospective analysis of genetic alterations in Cte DNA with clinical outcome.
Jeff will provide further details in his comments and slides.
Speaker Change: I will now provide a clinical review of the quarter and then Jeff Ludwig will address our additional color on Nearlink's commercial activities.
Speaker Change: The safety results from the combination arm of the trial showed that 40% of the patients experienced grade three or higher neutropenia, with 13% experiencing grade three or higher drug related febrile neutropenia.
Speaker Change: Maximo Nougues will then follow with highlights of the key components of our financial statements for the third quarter of 2024.
As previously discussed,
16% of the patients discontinued study treatment because of an adverse events and 38% of the patients had a dose reduction because of an adverse events. The primary endpoint of that trial was progression free survival or PFS for the ITT population the hazard ratio for PFS with zero point 707, with a P value of 0.113.
Speaker Change: Puma has an ongoing phase 2 study of our investigational drug alisertib to confirm the efficacy of alisertib monotherapy in patients with small cell lung cancer with biomarkers where the aurora kinase pathway plays a role.
Speaker Change: The goal is to correlate the efficacy in these biomarker subgroups in the ELISCA Lung 1 study to the efficacy that was previously seen in the biomarker subgroups from the randomized trial of papotaxel plus alacertin.
Speaker Change: One using the corrected definition for the stratification of relapsed type the hazard ratio for PFS with zero point 71, with a P value of 0.038 for the patients with chemotherapy resistant or refractory disease.
Speaker Change: versus Paclitaxel plus placebo that was published in the Journal of Thoracic Oncology in 2020.
Speaker Change: The hazard ratio was 0.66 with a P value of 0.037.
Speaker Change: If the efficacy and biomarker data are comparable from the two studies, the company believes it would represent a potential accelerated approval strategy and would engage FDA to discuss this further.
Speaker Change: With respect to the Biomarkers that were studied in that trial for the patients in the trial, who were found to be IAC positive for <unk> expression. The hazard ratio in the trial with zero point to nine with the median PFS for the Paclitaxel plus <unk>, a 464 months and a median PFS for the Paclitaxel plus placebo arm.
Speaker Change: As investors will remember, Alicertib was previously tested as a monotherapy in patients with small cell lung cancer. The results of this trial were published in Lancet Oncology in 2015.
Speaker Change: In this trial, Alisertab was administered as a monotherapy to patients with small cell lung cancer.
Speaker Change: 207 months also for patients with alterations and cell cycle genes, including CDK six <unk>, one <unk>, two and <unk>. The PFS for the Paclitaxel plus <unk> arm was 368 months, while the placebo plus Paclitaxel arm was one eight months and the hazard ratio for PFS with 0.3.
The safety results, N equals 60 from the trial.
Speaker Change: showed that 37% of the patients experienced grade 3-4 neutropenia, 7% experienced grade 3-4 drug-related febrile neutropenia, and 22% of the patients discontinued treatment due to adverse events.
Speaker Change: <unk> 95, with a P value of 0.003, the overall survival for that sub group of patients with seven two months for the <unk> arm and 447 months for the placebo arm with a hazard ratio of <unk>, seven and a P value of 0.00085.
Speaker Change: The efficacy results from an efficacy of valuable population of 48 patients showed that for the 36 chemotherapy-sensitive patients, the objective response rate was 19%, and the PFS was 2.6 months. And for the 12 chemotherapy-resistant or relapsed patients,
Speaker Change: When Puma licensed Al Assertive, we stated that one of our focuses what has tried to reduce the adverse event profile of the drug and more specifically the grade three or four neutropenia by giving prophylactic G. CSF with the administration of <unk> and this is being instituted in the <unk> one trial.
Speaker Change: The objective response rate was 25% with a PFS of 1.7 months.
Speaker Change: As investors will also remember, Alisertib was also previously tested in a randomized phase 2 trial of Paclitaxel plus Alisertib versus Paclitaxel plus placebo in patients with second-line small cell lung cancer, which was published in the Journal of Thoracic Oncology in 2020.
Speaker Change: Currently there are 20 patients enrolled in the <unk>, one trial with several in screening and pre screening for.
Al-Assertiv was dosed at a different
Speaker Change: For the first 18 patients who are available for safety, there's been one patient or five 6% with grade three or four neutropenia and one patient at five 6% with febrile neutropenia, no patient has discontinued <unk> due to adverse events and one patient or five 6% has.
Speaker Change: with Alzheimer's being administered at 40 milligrams BID for three weeks.
Speaker Change: on days 1 to 3, 8 to 10, and 15 to 17, plus Paclitaxel 60 mg intravenously on days 1, 8, and 15.
Speaker Change: Acquired a dose hold base.
Speaker Change: Based on the preliminary improved neutropenia and Tolerability that is being seen in the trial and assuming this continues to be seen the company is considering the potential to increase the dose of <unk> monotherapy in the trial.
Speaker Change: The trial also incorporated an extensive biomarker analysis with a pre-specified analysis of c-myc expression as well as a retrospective analysis of genetic alterations in ctDNA with clinical outcome.
Speaker Change: Also assuming this improved neutropenia and Tolerability continues to be seen when <unk> is combined with Paclitaxel. The company believes that it may result in better efficacy of the combination of Paclitaxel with al asserted.
Speaker Change: The safety results from the combination arm of the trial showed that 40% of the patients experienced grade 3 or higher neutropenia with 13% experiencing grade 3 or higher drug-related febrile neutropenia.
Speaker Change: And that the company may be able to increase the dose of <unk> that is able to be given with paclitaxel.
Speaker Change: Sixteen percent of the patients discontinued study treatment because of an adverse event and 38 percent of the patients had a dose reduction because of an adverse event.
Speaker Change: Okay.
Speaker Change: Of the 18 patients dosed with <unk> 16 has had a post baseline tumor assessments.
Speaker Change: Of these seven had chemotherapy sensitive disease, which is defined as a relapse more than 90 days, but less than a 180 days after primary treatment.
Speaker Change: The primary endpoint of that trial was progression-free survival, or PFS.
Speaker Change: For the ITT population, the hazard ratio for PFS was 0.77, with a p-value of 0.113.
Speaker Change: And nine had chemotherapy resistant or refractory disease defined as relapsed less than 90 days after primary treatments in.
Speaker Change: When using the corrected definition for the stratification of relapse type, the hazard ratio for PFS was 0.71 with a p-value of 0.038.
Speaker Change: In the chemotherapy sensitive patients one patients or 14% as shown stable disease and the median PFS has been one or two months in the patients with chemotherapy resistant or refractory disease there've been two patients or 22% with a partial response and one patient or 11% with stable disease.
for the patients with chemotherapy-resistant or refractory disease.
The hazard ratio was 0.66 with a p-value of 0.037
Speaker Change: with respect to the biomarkers that were studied in that trial.
Speaker Change: for the patients in the trial who were found to be IHC positive for C-Myc expression. The hazard ratio in the trial was 0.29, with a median PFS for the paclitaxel plus alicerative arm of 4.64 months and a median PFS for the paclitaxel plus placebo arm of 4.64 months.
Speaker Change: And the median PFS has been one four months.
As previously mentioned we are conducting an extensive analysis of the biomarkers that are known to be involved with the Aurora kinase pathway activation.
Speaker Change: To see if it correlates with clinical outcome.
of 2.27 months.
Speaker Change: The two refractory or resistant.
Speaker Change: Patients with partial responses did have biomarkers that correlate with the Aurora kinase pathway activation, including <unk> mutations and Mick gains. We caution that this is very early data and we do not have tissue on all of the patients enrolled so the number of patients with biomarker data is too.
Speaker Change: and the hazard ratio for PFS was 0.395 with a p-value of 0.003.
Speaker Change: Small to be able to draw definitive conclusions and the associations between Biomarkers and <unk> activity.
Speaker Change: The overall survival for that subgroup of patients was 7.2 months for the allocerative arm and 4.47 months for the placebo arm with a hazard ratio of 0.427 and a p-value of 0.00085
Speaker Change: The company believes that the preliminary data from the <unk>. One trial is providing a preliminary indication of potentially better activity in patients with chemotherapy resistant or refractory disease, which is similar to what we're seeing in the trial published in the lancet oncology in the randomized trial that was published in the journal of thoracic oncology.
Speaker Change: When PUMA licensed Alisertib, we stated that one of our focuses was to try to reduce the adverse event profile of the drug, and more specifically the grade 3-4 neutropenia, by giving prophylactic GCSF with the administration of Alisertib, and this is being instituted in the ELISCO Lung 1 trial.
The company plans to continue enrollment in the <unk>, one trial and anticipate additional data will be presented at medical conferences in 2025. The company also plans to meet with its steering committee for the trial in order to determine the next steps for the drug in the treatment of small cell lung cancer patients. The company one keep investors updated on this as it.
Speaker Change: Currently there are 20 patients enrolled in the ELISCO LUN1 trial with several in screening and pre-screening.
Speaker Change: For the first 18 patients who were available for safety, there has been one patient or 5.6% with grade 3-4 neutropenia and one patient, 5.6%, with febrile neutropenia.
Progress.
Speaker Change: Investors will also remember that the company plans to test <unk> in Alaska in the <unk>, one trial, a phase III trial of <unk> in combination with endocrine treatments and patients with chemotherapy naive her two negative hormone receptor positive metastatic breast cancer.
Speaker Change: No patient has discontinued L-Assertive due to adverse events and one patient or 5.6% has required a dose hold.
Speaker Change: Based on the preliminary improved neutropenia and tolerability that is being seen in the trial, and assuming this continues to be seen, the company is considering the potential to increase the dose of L-assertive monotherapy in the trial.
There are three sites that have been activated for the trial.
We anticipate the initiation of the trial in the fourth quarter of 2024.
Speaker Change: The company will keep investors updated on this as it progresses.
Speaker Change: Also, assuming this improved neutropenia and tolerability continues to be seen when L-assertive is combined with Paclitaxel, the company believes that it may result in better efficacy of the combination of Paclitaxel with L-assertive.
Speaker Change: As mentioned on prior earnings calls and in response to Investor questions. Puma continues to evaluate several drugs to potentially in license that will allow the company to diversify itself and leverage <unk> existing R&D regulatory and commercial infrastructure the.
Speaker Change: and that the company may be able to increase the dose of aloesertibs that is able to be given with Baclofaxil.
Speaker Change: The company will keep investors updated on this as it progresses.
Speaker Change: Of the 18 patients dosed with Alizertib, 16 have had a post-baseline tumor assessment.
Speaker Change: I will now turn the call over to Jeff Ludwig <unk>, Chief Commercial officer for a review of our commercial performance during the quarter.
Speaker Change: Of these, seven had chemotherapy sensitive disease which is defined as a relapse more than 90 days but less than 180 days after primary treatment.
Jeff Ludwig: Thanks, Alan I appreciate it and thanks to everyone for joining our third quarter earnings call.
Jeff Ludwig: Before I move into the commercial review just a reminder, that I will be making forward looking statements.
Speaker Change: and nine had chemotherapy resistant or refractory disease defined as relapsed less than 90 days after primary treatments.
Jeff Ludwig: The commercial team is focused on increasing the utilization of neuro links with an emphasis on her two positive early stage breast cancer patients who are deemed to have a higher risk of reoccurring.
Speaker Change: In the chemotherapy-sensitive patients, one patient, or 14%, has shown stable disease, and the median PFS has been 1.2 months.
Jeff Ludwig: A significant portion of these patients are treated in the community setting and are being seen by a large number of community oncologists.
Speaker Change: In the patients with chemotherapy resistant or refractory disease there have been two patients or 22% with a partial response and one patient or 11% with stable disease and the median PFS has been 1.4 months.
Jeff Ludwig: Given this broad distributions of patients, it's very important to look for opportunities to increase share of voice through personal andother non personal promotion with a focus on trying to engage physicians at the proper time, when they are making treatment decisions related to the extended adjuvant setting.
Speaker Change: As previously mentioned, we are conducting an extensive analysis of the biomarkers that are known to be involved with the aurora kinase pathway activation.
to see if it correlates with clinical outcome.
Jeff Ludwig: HCP call activity increased about 11% quarter over quarter and about 17% year over year.
patients with partial responses
Speaker Change: did have biomarkers that correlate with the aurora kinase pathway activation including RB1 mutations and MYC gains.
Consistent with the last several quarters. The majority of our calls continued to be live interactions, but the team does look for opportunities to leverage virtual calls depending on the situation.
Speaker Change: We caution that this is very early data, and we do not have tissue on all the patients enrolled, so the number of patients with biomarker data is too small to be able to draw definitive conclusions on the associations between biomarkers and allocertive activity.
Jeff Ludwig: In Q3, greater than 80% of our calls rely of interactions, which is very similar to what we reported in Q2 of this year.
Jeff Ludwig: The commercial team is committed to finding ways to utilize our resources more efficiently and effectively we are evaluating new partners, new data and new approaches with a goal of improving our impact and ultimately increasing the utilization of <unk>.
Thank you.
Speaker Change: The company believes that the preliminary data from the ELISCO-1 trial is providing a preliminary indication of potentially better activity in patients with chemotherapy resistant or refractory disease.
Speaker Change: which is similar to what was seen in the trials published in the Lancet Oncology and the randomized trial that was published in the Journal of Thoracic Oncology.
Jeff Ludwig: Let me now transition to some of the commercial slides, where I will provide some additional specifics around performance. Once finished I will turn the call over to Maximo for a more detailed review of our financial results.
Speaker Change: The company plans to continue enrollment in the ELISCO-1 trial and anticipates additional data will be presented at medical conferences in 2025.
Jeff Ludwig: Okay.
Jeff Ludwig: Looking at slide three slide three is an overview of our distribution model, which is broken out into the specialty pharmacy channel and our specialty distributor were in office excuse me or in office dispensing channel, we do see quarterly fluctuations, but the majority of our business continues to flow through the specialty pharmacy channel.
Speaker Change: The company also plans to meet with its steering committee for the trial in order to determine the next steps for the drug in the treatment of small cell lung cancer patients.
Speaker Change: The company will keep investors updated on this as it progresses.
Speaker Change: Investors will also remember that the company plans to test alicertib in the ALISCA BRESS 1 trial, a phase 2 trial of alicertib in combination with endocrine treatment.
Jeff Ludwig: In Q3 about 74% of our business pass through the specialty pharmacy channel, which is similar to the 72% we reported during our Q2 earnings call.
Speaker Change: patients with chemotherapy naive, HER2 negative, hormone receptor positive metastatic breast cancer.
Jeff Ludwig: Okay.
Jeff Ludwig: Moving to slide four.
Speaker Change: Currently there are three sites that have been activated for the trial and we anticipate the initiation of the trial in the fourth quarter of 2024.
Jeff Ludwig: <unk> net revenue in Q3 of 2024 was $56 1 million, which represents an increase of $11 7 million from the $44 4 million, we reported in Q2 of 2024.
Speaker Change: The company will keep investors updated on this as it progresses.
Speaker Change: As mentioned on prior earnings calls and in response to investor questions, Puma continues to evaluate several drugs to potentially in-license that will allow the company to diversify itself and leverage Puma's existing R&D, regulatory, and commercial infrastructure.
Jeff Ludwig: And a $4 $5 million increase from the $51 6 million, we reported in Q3 of 2023.
Jeff Ludwig: The significant change in quarterly net revenue was primarily driven by four factors number one inventory changes number two higher U S ex factory sales.
Speaker Change: The company will keep investors updated on this as it progresses.
Speaker Change: I will now turn the call over to Jeff Ludwig, PUMA's Chief Commercial Officer, for a review of our commercial performance during the quarter.
Jeff Ludwig: Number three increased product supply revenue to our global partners and for a lower gross to net adjustment.
Speaker Change: I will provide some more details around inventory changes and maximum we will provide some additional specifics during his update.
Jeff Ludwig: Thanks, Alan. Appreciate it. And thanks to everyone for joining our third quarter earnings call.
Jeff Ludwig: Before I move into the commercial review, just a reminder that I will be making forward-looking statements.
Speaker Change: In regards to the inventory we estimate the inventory increased by about $600000 in Q3 of 2024.
Jeff Ludwig: The commercial team is focused on increasing the utilization of Neuralinks with an emphasis on HER2-positive early stage breast cancer patients who are deemed to have a higher risk of reoccurrence.
Speaker Change: As a comparison, we estimate that inventory decreased by about $2 3 million in Q2 of 2024 and increased by about 600000 in Q3 of 2023.
Jeff Ludwig: A significant portion of these patients are treated in a community setting and are being seen by a large number of community oncologists.
Speaker Change: Slide five shows Q3 2024 ex factory bottle sales and also provides both a year over year and quarter over quarter comparison.
Jeff Ludwig: Given this broad distribution of patients, it's very important to look for opportunities to increase share of voice through personal and or non-personal promotion with a focus on trying to engage physicians at the proper time when they are making treatment decisions related to the extended adjuvant setting.
Speaker Change: In Q3 of 2020 for neuro links ex factory bottle sales were 2723, which represents an approximate 8% quarter over quarter increase and a 5% year over year decrease.
Jeff Ludwig: HCP call activity increased about 11 percent quarter over quarter and about 17 percent year over year.
Speaker Change: In regards to inventory impact we estimate the inventory increased by about 37 bottles in Q3 of 2024.
Jeff Ludwig: Consistent with the last several quarters, the majority of our calls continue to be live interactions, but the team does look for opportunities to leverage virtual calls depending on a situation.
Speaker Change: As a comparison, we estimate the inventory decreased by about 132 models in Q2 of 2024 and increased by about 32 bottles in Q3 of 2023.
Jeff Ludwig: In Q3, greater than 80% of our calls were live interactions, which is very similar to what we reported in Q2 of this year.
Now, let me take just a moment to provide some additional metrics and insights into our third quarter performance.
Jeff Ludwig: The commercial team is committed to finding ways to utilize our resources more efficiently and effectively. We are evaluating new partners, new data, and new approaches with the goal of improving our impact and ultimately increasing the utilization of Neuralinks.
Speaker Change: In Q3, we saw on new patient starts or interacts increased by about 3% quarter over quarter and about 8% year over year.
Speaker Change: Total prescriptions or <unk> were flat quarter over quarter and down about 8% year over year.
Jeff Ludwig: Let me now transition to some of the commercial slides where I will provide some additional specifics around performance.
Speaker Change: Overall demand increased by about one 5% quarter over quarter, but was down about 5% year over year.
Jeff Ludwig: Once I have finished, I will turn the call over to Maximo for a more detailed review of our financial results.
Speaker Change: Enrollments and SD demand are also important factors in looking at our performance enrollments are an important leading indicator as we have discussed previously as a reminder, enrollments turned into new patient starts new patient starts turning to refills, which impact demand in subsequent quarters.
Jeff Ludwig: Looking at slide 3, slide 3 is an overview of our distribution model which is broken out into the specialty pharmacy channel and the specialty distributor or in office, excuse me, or in office dispensing channel.
Jeff Ludwig: We do see quarterly fluctuations, but the majority of our business continues to flow through the specialty pharmacy channel.
Speaker Change: In Q3 enrollments were down just under 1% quarter over quarter and were up approximately 10% year over year.
Jeff Ludwig: In Q3, about 74% of our business passed through the specialty pharmacy channel, which is similar to the 72% we reported during our Q2 earnings call.
Speaker Change: As a reminder, and as we mentioned during our Q3 2023 earnings call last year, we did see some enrolment softness last year that largely occurred in the first part of Q3 of 2023 <unk>.
I'm sorry. I'm sorry. I'm sorry. I'm sorry.
Moving to slide four.
Jeff Ludwig: NeurLink's net revenue in Q3 of 2024 was $56.1 million, which represents an increase of $11.7 million from the $44.4 million we reported in Q2 of 2024.
Speaker Change: That softness is contributing to this positive year over year comparison.
SD demand is also an important performance indicator as there are patients that are treated solely in the SD channel, which means we will never capture and enrollment from this group.
Jeff Ludwig: and a $4.5 million increase from the $51.6 million we reported in Q3 of 2023.
Speaker Change: SD demand increased 5% quarter over quarter, and 13% year over year.
Jeff Ludwig: The significant change in quarterly net revenue was primarily driven by four factors. Number one, inventory changes. Number two, higher U.S. ex-factory sales. Number three, increased product supply revenue to our global partners. And four, a lower gross-to-net adjustment.
Speaker Change: Turning to slide six slide six highlights the quarterly adoption of dose Escalations since <unk> launch in Q3, approximately 65% of patients started <unk> at a reduced dose. This is similar to the 66% that was reported in Q2 of this year.
Jeff Ludwig: I will provide some more details around inventory changes and Maximo will provide some additional specifics during his update.
Speaker Change: The benefits of dose escalation to initiate therapy with <unk> continues to be.
Speaker Change: To be an important part of our commercial messaging.
Jeff Ludwig: In regards to inventory, we estimate that inventory increased by about $600,000 in Q3 of 2024.
Speaker Change: The control trial showed a significant reduction in grade three diarrhea, and showed improved persistence and compliance when patients were started at a lower dose.
Jeff Ludwig: As a comparison, we estimate that inventory decreased by about $2.3 million in Q2 of 2024 and increased by about $600,000 in Q3 of 2023.
Speaker Change: We track multiple cohorts of patients and continue to see improved persistence when patients are started at a lower dose.
Speaker Change: The commercial team continues to explore additional opportunities to better support patients throughout their <unk> therapy.
Jeff Ludwig: Slide 5 shows Q3 2024 X-Factory bottle sales and also provides both a year-over-year and a quarter-over-quarter comparison.
Speaker Change: Slide seven highlights the strategic collaborations we have formed across the globe in Q3, <unk> received regulatory approval in Algeria, and the extended adjuvant setting.
Speaker Change: In addition, <unk> was launched in both South Africa, and the United Arab Emirates also in the extended adjuvant setting.
Jeff Ludwig: In regards to inventory impact, we estimate that inventory increased by about 37 bottles in Q3 of 2024.
Speaker Change: We really appreciate the excellent work being done by our partners around the globe and look forward to supporting their continued success moving forward.
I'd like to wrap up by thanking my Puma colleagues for their unwavering commitment. The team is passionate about making a difference in the lives of patients and their families battling cancer. The commercial team remains focused on finding ways to be more efficient and effective with our resources and also fully committed to balancing the short term and long term priorities of Puma and <unk>.
Jeff Ludwig: As a comparison, we estimate that inventory decreased by about 132 bottles in Q2 of 2024 and increased by about 32 bottles in Q3 of 2023.
Jeff Ludwig: Now let me take just a moment to provide some additional metrics and insights into our third quarter performance.
Our holders I will now turn the call over to maximum into gas for a review of our financial results Maximo.
Jeff Ludwig: In Q3, we saw new patient starts, or NRX, increase by about 3% quarter over quarter and about 8% year over year.
Speaker Change: Thanks, Jeff.
Maximo: Let me begin with a brief summary of our financial results the third quarter of 2024.
Total prescriptions or TRX were flat
Please note I will make comparisons to Q2 2020 for which.
Jeff Ludwig: Overall demand increased by about 1.5 percent quarter-over-quarter but was down about 5 percent year-over-year.
Maximo: Which we believe is a better indication of our progress as a commercial company and year over year comparisons.
Jeff Ludwig: Enrollments and SD demand are also important factors in looking at our performance. Enrollments are an important leading indicator, as we have discussed previously. As a reminder, enrollments turn into new patient starts. New patient starts turn into refills, which impact demand in subsequent quarters.
Maximo: For more information I recommend that you refer to Q3, which will be filed today and includes our consolidated financial statements.
For the third quarter of 2024, we reported net income based on GAAP of $20 3 million.
Jeff Ludwig: In Q3, enrollments were down just under 1% quarter-over-quarter and were up approximately 10% year-over-year.
Maximo: <unk> 41 per share.
Maximo: This compares to net loss in Q2 2024.
Maximo: $4 5 million or <unk> <unk> per share.
Jeff Ludwig: As a reminder, and as we mentioned during our Q3 2023 earnings call last year, we did see some enrollment softness last year that largely occurred in the first part of Q3 of 2023. That softness is contributing to this positive year-over-year comparison.
Maximo: And a non-GAAP basis, just adjusted to remove the impact of stock based compensation expense.
Maximo: We reported net income was $22 four or.
Maximo: 45.
Maximo: Sure.
Maximo: Third quarter of 2024.
Jeff Ludwig: SD demand is also an important performance indicator, as there are patients that are treated solely in the SD channel, which means we will never capture an enrollment from this group.
Maximo: Gross revenue from.
<unk> was six.
$67 7 million in Q3 2024 and.
Maximo: $55 <unk> million in Q2 2024.
Jeff Ludwig: SD demand increased 5% quarter over quarter and 13% year over year.
Alan mentioned it net product revenue from <unk> sales was.
Maximo: <unk> $56 1 million an improvement from the $44 4 million reported in Q2 2024.
Jeff Ludwig: Turning to slide six, slide six highlights the quarterly adoption of dose escalation since NeurLynx launch. In Q3 approximately 65% of patients started NeurLynx at a reduced dose. This is similar to the 66% that was reported in Q2 of this year.
Maximo: Higher product sales to our global partners of about $7 4 million.
Higher U S demand and lower gross to net adjustment drove the higher sales versus Q2 2024.
Jeff Ludwig: The benefits of dose escalation to initiate therapy with Neuralinks continues to be an important part of our commercial messaging.
Maximo: Yes.
Maximo: Inventory increased by our distributor was approximately $2 6 million in Q3.
Jeff Ludwig: The control trial showed a significant reduction in grade 3 diarrhea, and showed improved persistence and compliance when patients were started at a lower dose.
Maximo: Versus approximately $2 $3 million of drawdown in Q2 2024.
Maximo: Royalty revenue totaling $24 4 million in the third quarter of 2020 compared to $2 7 million in Q2.
Jeff Ludwig: We track multiple cohorts of patients and continue to see improved persistence when patients are started at a lower dose.
Speaker Change: The commercial team continues to explore additional opportunities to better support patients throughout their Neuralink's therapy.
Maximo: Our gross to net adjustment in Q3 was about 17, 1%.
Speaker Change: Slide 7 highlights the strategic collaborations we have formed across the globe. In Q3, NeurAlynx received regulatory approval in Algeria in the extended adjuvant setting.
Maximo: Compared to the 24% gross to net adjustment reported in Q2 2020.
Maximo: Cost of sales for Q3 2024.
Speaker Change: In addition, Neuralinks was launched in both South Africa and the United Arab Emirates, also in the extended adjuvant setting.
Maximo: <unk> to $29 1 million.
Maximo: Collecting the cells of Netflix through our grow our China partner.
Speaker Change: We really appreciate the excellent work being done by our partners around the globe and look forward to supporting their continued success moving forward.
Maximo: And includes $2 4 million for the amortization of intangible assets related to our Neurotogenic license.
Wholesale sales for Q2 2024 was $10 seven.
Speaker Change: I'd like to wrap up by thanking my PUMA colleagues for their unwavering commitment.
Maximo: Going forward, we will continue to recognize amortization of the milestones to the license or about $2 4 million per quarter as cost of sales.
Speaker Change: The team is passionate about making a difference in the lives of patients and their families battling cancer. The commercial team remains focused on finding ways to be more efficient and effective with their resources and also fully committed to balancing the short-term and long-term priorities of Puma and its shareholders.
For fiscal year 2024.
Maximo: On DCP.
Maximo: Net product revenue for Nellix will be in the range of 187% to 190 minutes.
Speaker Change: I will now turn the call over to Maximo Nougues for a review of our financial results. Maximo?
Maximo Nougues: Thanks Jeff. I will begin with a brief summary of our financial results for the third quarter of 2024.
Maximo: We also anticipate that our gross to net adjustment for the full year 2024 will be between 25% and 21, 5%.
Maximo Nougues: Please note that I will make comparisons to Q2 2024, which we believe is a better indication of our progress as a commercial company and year-over-year comparisons.
Maximo: Higher than 2023 due to the impact of inflation reduction.
Maximo: Unexpected Medicaid rebates.
Maximo Nougues: For more information, I recommend that you refer to our Q3 thank you, which will be filed today and includes our consolidated financial statements.
Maximo: In addition for fiscal year 2024, we anticipate receiving royalties from our partners around the world in the range of 34 to 36 million.
Maximo Nougues: For the third quarter of 2024, we reported net income, based on GAAP, of $20.3 million, or $0.41 per share. This compares to net loss in Q2 2024 of $4.5 million, or $0.09 per share.
Maximo: We expect license revenue in 2024 in the range of $1 million to $2 million.
Maximo: We also expect our net income for the full year would be in the range of 15% to 17.
We anticipate that from Q4 2024, <unk> net product revenue will be in the range of 46 to 48 million.
Maximo Nougues: On a non-gap basis, which is adjusted to remove the impact of stock-based compensation expense, we reported a net income of $22.4 million, or $0.45 per diluted share, for the third quarter of 2024.
Maximo: We expect Q4 royalties revenues will be in the range of $3 five 5 million.
Maximo: We anticipate $1 million to $2 million of license revenue.
[inaudible]
Maximo Nougues: Gross revenue from Narinxels was $67.7 million in Q3 2024 and $55.8 million in Q2 2024.
Maximo: We further estimate that the gross to net adjustment in Q4, 'twenty 'twenty four will be approximately 21% 22%.
Maximo: Puma anticipates Q4, net income between $4 million.
Maximo Nougues: As Alan mentioned it, net product revenue from Netlix sales was $56.1 million, an improvement from the $44.4 million reported in Q2 2024.
Maximo: SG&A expenses were $16 8 million in the third quarter of 2024.
Maximo: $25 million for the second quarter of plant anymore.
Maximo Nougues: Higher product sales to our global partners of about 7.4 million. Higher U.S. demand and lower gross-to-net adjustment drop the higher sales versus Q2 2024.
Maximo: SG&A expenses included noncash charges for stock based compensation of $1.
Maximo: 5 million from Q3 2024.
Maximo: Up from $1 4 million in Q2.
Maximo Nougues: Inventory increased by our distributor was approximately 0.6 million in Q3.
Maximo: Research and development expenses were $12 5 million in the third quarter of plants on the floor down from $13 6 million in the second quarter plant anymore.
versus approximately 2.3 million of drawdown in Q2 2024.
Maximo Nougues: Loyalty revenue totaled $24.4 million in the third quarter of 2024, compared to $2.7 million in Q2 2024.
R&D expenses included noncash charges for stock based compensation of <unk> 6 million in the third quarter of 2020.
Maximo: Unchanged from the second quarter when the clinical.
Our gross net adjustment in Q3 2024 was about 17.1%.
Maximo: On the expense side, Puma anticipates flat to slightly lower operating expenses in 2024 compared to 2023.
Maximo Nougues: compared to the 20.4% gross to net adjustment reported in Q2 2024.
More specifically, we anticipate SG&A expenses to decrease by 10% to 12%.
Maximo Nougues: Cost of sales for Q3 2024 increased to $29.1 million, reflecting the sales of Nerlix to our China partner.
Maximo: R&D expenses to increase 11% to 14% year over year.
Maximo Nougues: and includes 2.4 million for the amortization of intangible assets related to our neurotic license.
Maximo: In the third quarter of 2024, Puma reported cash burn of approximately zero point $1 million.
Cost of sales for Q2 2024 was $10.7 million.
Maximo: This compares to a cash burn of approximately $10 3 million in Q2 'twenty two before.
Maximo Nougues: Going forward, we will continue to recognize amortization of the milestones to the licensure about $2.4 million per quarter as cost of sales.
Maximo: Please note that during.
Maximo: In Q3, we made our second principal loan payments of $11 1 million related to our obligation with a theory.
[inaudible]
Maximo Nougues: For fiscal year 2024, PUMA anticipates that net product revenue for Nellings will be in the range of $187 to $290 million.
Maximo: As a result of this our outstanding principal debt volumes decreased to approximately $78 1 million.
Maximo: At September 32024, we had approximately 97 million in cash cash equivalents and marketable securities.
Maximo Nougues: We also anticipate that our gross student adjustment for the full year 2024 will be between 20.5% and 21.5%.
Maximo: Versus about $96 million at year end in 2020.
Maximo Nougues: higher than 2023 due to the impact of the Inflation Reduction Act.
Maximo: Our accounts receivable balance was 60 $54 6 million.
unexpected Medicaid rebates.
Maximo: Our accounts receivable terms range between 10 and 68 days.
Maximo Nougues: In addition, for fiscal year 2024, we anticipate receiving royalties from our partners around the world in the range of $34 to $36 million.
Maximo: But our days sales outstanding are about 48 days.
Maximo: We estimate that as of September 32024 hour distribution levels maintain approximately three weeks of inventory.
Maximo Nougues: We expect license revenue in 2024 in the range of 1 to 2 million.
Maximo: Overall, we continue to deploy our financial resources focused on the commercialization of earnings.
Maximo Nougues: We also expect that that income for the full year will be in the range of 15 to 17 million.
Speaker Change: Development Nabavi sensitive.
Speaker Change: Consolidated <unk> expenses.
Maximo Nougues: We anticipate that for Q4 2024, Neuralink's Net Product Revenue will be in the range of 46 to 48 million.
Speaker Change: Thanks Maximo.
Puma Senior management in cooperation with the board of Directors continues to remain focused on narrowing sales trends in 2024 and beyond and recognizes its fiscal responsibility to shareholders continue to to continue to maintain a positive net income.
Maximo Nougues: We expect Q4 royalties revenues will be in the range of 3.5 to 5 million and we anticipate 1 to 2 million of licensed revenue.
Maximo Nougues: We further estimate that the gross net adjustment in Q4 2024 will be approximately 21% to 22%.
In the fourth quarter of 2021, we implemented a reduction in expenses with the goal of reducing expenses in order to maximize operational cash flows. We believe that the positive net income that was seen in 2023 resulted from these expense reductions the expense reductions that we have previously performed and continue to perform.
Speaker Change: and Puma anticipates Q4 net income between $4 million and $6 million.
Speaker Change: His GNA expenses were $16.8 million in the third quarter of 2024, compared to $25 million for the second quarter of 2024.
Speaker Change: Are also a major contributor to the positive net income that the company achieved in Q3 of 2024 and that the company is guiding for 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 this we look forward.
Speaker Change: as G&A expenses included non-cash charges for stock-based compensation of $1.5 million for Q3 2024 up from $1.4 million in Q2 2024.
Speaker Change: Research and development expenses were $12.5 million in the third quarter of 2024, down from $13.6 million in the second quarter of 2024.
Speaker Change: To updating investors on this in the future.
Speaker Change: There continues to remain a significant unmet need for patients battling breast cancer lung cancer and other solid tumors, we had kumar our committed and passionate about finding more effective ways of helping these patients during their journey and we will continue to strive to achieve that goal.
Speaker Change: R&D expenses include the non-cash charges for stock-based compensation of $0.6 million in the third quarter of 2024, unchanged from the second quarter of 2024.
Speaker Change: This concludes today's presentation, we will now turn the floor back to the operator for Q&A.
Speaker Change: Operator.
Speaker Change: We will now begin the question and answer session.
Speaker Change: If you wish to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate airlines in the question queue.
Speaker Change: If you wish to withdraw your request please press star two.
Speaker Change: Vince using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.
Speaker Change: One moment, please when we poll for questions.
Speaker Change: This compares to a cash burn of approximately $10 3 million in Q2, 'twenty 'twenty four.
Speaker Change: Thank you and your first question comes from the line of Ed White with H C. Wainwright. Please proceed with your question.
Speaker Change: Please note that during Q3, we made our second principal loan payments of $11 1 million.
Speaker Change: Okay.
Speaker Change: Related to our obligation with a theory.
Speaker Change: Good afternoon, Thanks for taking my questions and congratulations on the quarter.
Speaker Change: As a result of this our outstanding principal debt balance decreased to approximately $78 1 million.
Alan and I just wanted to get your thoughts on the sales.
Speaker Change: Exceeding expectations.
Speaker Change: Our September 32024, we had approximately 97 million in cash cash equivalents and marketable securities.
Speaker Change: What are you attributing that to when you dig down into it and then also what.
Speaker Change: So about 96 million at year end in 2023.
Speaker Change: How does persistence play into that as you keep saying that as patients are using the lower doses. They remain on drug longer. So just wanted to get your thoughts on how that's playing through.
Speaker Change: Our accounts receivable balance was 60 $54 6 million.
Speaker Change: Our accounts receivable terms range between 10 and 68 days.
Speaker Change: In the in the revenue numbers.
Speaker Change: Our days sales outstanding are about 48 days.
Speaker Change: Yes. Thanks I appreciate the questions I would say a couple of things in terms of demand numbers, one as we stayed over and over we believe this drug is very promotional sensitive and so trying to get the field force in front of more customers on a regular basis continues to be a very key priority for us.
Speaker Change: We estimate that as of September 30th 24.
Speaker Change: Our distribution network maintains approximately three weeks of inventory.
Speaker Change: Overall, we continue to deploy our financial resources focused on the commercialization of <unk> <unk>.
Speaker Change: Element of body surface.
Speaker Change: And not only is it getting in front of them, but trying to get in front of these customers at the time. They are making decisions is also a huge priority for us and some of the things. We're trying to do to make that happen are leveraging claims data to find out who what doctors have patients now looking at NPP when folks are engaging.
Speaker Change: Finally in our expenses.
Speaker Change: Thanks Maximo.
Speaker Change: 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 continue to to continue to maintain a positive net income.
Speaker Change: With our NPP learning more about <unk>, that's obviously a signal to us that they are making decisions. So we're trying to get much better with the data to drive the location of our sales force.
Speaker Change: In the fourth quarter of 2021, we implemented a reduction in expenses with the goal of reducing expenses in order to maximize operational cash flows. We believe that the positive net income that was seen in 2023 resulted from these expense reductions the expense reductions that we have previously performed and continue to perform.
Speaker Change: I would say, we're also seeing very nice conversion from enrollment to new patient starts the commercial new patient starts. The team is following up on any pending or delayed cases and that is also a big priority for us.
Speaker Change: Are also a major contributor to the positive net income that the company achieved in Q3 of 2024 and that the company is guiding for for full year 2024. The company remains committed to continuing to achieve this positive net income and we will continue to reduce expenses if needed to achieve this we look for.
Speaker Change: You asked lastly, about persistence and we continue to see at any stage along the persistence curve, whether it's first refill second third or fourth we see about 10, let's say, 5% to 10% of more patients on drug at any given time, if they started with low dose as opposed to starting at full.
Speaker Change: Word to updating investors on this in the future.
Speaker Change: There continues to remain a significant unmet need for patients battling breast cancer lung cancer and other solid tumors. We akuma 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 Change: Dose so that continues to be a big priority for us and that does drive better overall bottles per patient.
Speaker Change: Let me know if that helps helpful. If you have more questions.
Speaker Change: No that's great. Thank you.
Alan Auerbach: And Alan Thanks for.
Alan Auerbach: The update on Alberta.
Speaker Change: This concludes today's presentation, we will now turn the floor back to the operator for Q&A.
You had mentioned about looking still looking at business other business development opportunities.
Speaker Change: Operator.
Speaker Change: How should we be thinking about what youre looking at are you looking at something.
Speaker Change: We will now begin the question and answer session.
Speaker Change: If you wish to ask a question. Please press star one on your telephone keypad, a confirmation tone will indicate airlines in the question queue.
Speaker Change: That you can leverage your current sales force and also perhaps use in concert with our <unk> or how should we be thinking about what you look for.
Speaker Change: If you wish to withdraw your request please press star two.
Speaker Change: Since using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.
Speaker Change: Yeah, Ed Thanks for the question.
Speaker Change: Yes in terms of looking at assets we have.
Speaker Change: One moment, please when we poll for questions.
Speaker Change: Always our ongoing looking at additional assets to bring in.
Speaker Change: Thank you and your first question comes from the line of Ed White with H C. Wainwright. Please proceed with your question.
Are we interested in commercial assets that we could leverage our existing sales force and could put us in a position.
Speaker Change: Good afternoon, Thanks for taking my questions and congratulations on the quarter.
Speaker Change: To kind of have that channel teed up if you will for Alastair.
Speaker Change: Alan and Jeff I, just wanted to get your thoughts on the sales.
Absolutely that would be something of interest to us.
Speaker Change: So we're looking across.
Speaker Change: It's exceeding expectations.
Speaker Change: Across the span if you will and there is no question, bringing in additional commercial assets, we think would make a lot of sense.
Speaker Change: What are you attributing that to when you dig down into it.
And then also what.
Speaker Change: Especially if they could put us in a position to.
Speaker Change:
Speaker Change: How it is persistence play into that as you keep saying that patients are using the lower doses. They remain on drug longer. So just wanted to get your thoughts on how that's playing through.
Speaker Change: To kind of lay the groundwork for <unk>.
Speaker Change: Okay. Thanks for taking my questions and then if I could just follow up on one question.
Speaker Change: In the in the revenue numbers.
Speaker Change: China grows when you have that that bolus of patients.
Speaker Change: Yeah, and thanks I appreciate the questions I would say a couple of things in terms of demand numbers, one as we stayed over and over we believe this drug is very promotional sensitive and so trying to get the field force in front of more customers on a regular basis continues to be a very key priority for us.
That's the way, we should be thinking of the sale.
Speaker Change: Sales into China in 2025 to that.
Speaker Change: It's going to be.
Speaker Change: Lumpy like that.
Speaker Change: And if you look historically at our sales to China, It's always been lumpy and the reason for that is that we kind of have a sale into the distribution channel kind of in that in those kind of lumpy bolus is if you will so it's always been like that quarterly and I would anticipate it would probably.
Speaker Change: And not only is it getting in front of them, but trying to get in front of these customers at the time. They are making decisions is also a huge priority for us and some of the things. We're trying to do to make that happen are leveraging claims data to find out who what doctors have patients now looking at NPP when folks are engaging.
Speaker Change: Yes, I would anticipate it would not change in 2025.
Speaker Change: Okay. Thanks for taking my questions.
Speaker Change: With our NPP learning more about neuro lengths, that's obviously a signal to us that they are making decisions. So we're trying to get much better with the data to drive location of our Salesforce.
Speaker Change: The next question is coming from the line of David Ross with TD Cowen. Please proceed with your questions.
Speaker Change: Hey, guys. Thanks for taking my question.
Speaker Change: I would say, we're also seeing very nice conversion from enrollments to new patient starts do commercial new patient starts. The team is following up on any pending or delayed cases and that is also a big priority for us.
Speaker Change: My congrats on that initial data in lung cancer.
Speaker Change: Just a couple of questions on that are the two patients that had a PR still on the trial.
Speaker Change: The data cut and then just in terms of expanding the dose or expanding that the dose range potentially.
Speaker Change: You asked lastly, about persistence and we continue to see at any stage along the persistence curve, whether it's first refill second third or fourth we see about 10, let's say, 5% to 10% of more patients on drug at any given time, if they started with low dose as opposed to starting at full.
Speaker Change: You have to meet with the FDA before looking at yes.
Speaker Change: Increased does with Alastair and then how long.
Speaker Change: Or are you thinking about maybe how many doses youre planning on exploring is it just one or are you trying to go are you trying to do like a sequential dose escalation to figure out.
Speaker Change: Dose so that continues to be a big priority for us and that does drive better overall bottles per patient.
Speaker Change: Kind of where he can get the most efficacy. Thank you.
Speaker Change: Yes.
Speaker Change: Thanks for the questions David.
Speaker Change: Let me know if that helps helpful. If you have more questions.
Speaker Change: In terms of the two patients who are.
Speaker Change: No that's great. Thank you.
Speaker Change: With the <unk> I apologize I don't have the data in front of me. So I don't know the answer that question.
Alan Auerbach: And Alan Thanks for.
The update on the I'll start there.
Speaker Change: You had mentioned about you know looking still looking at business other business development opportunities.
Speaker Change: With regard to the dose.
Speaker Change: You'll remember that we license this dose this drug from Takeda.
Speaker Change: How should we be thinking about what youre looking at are you looking at something.
Speaker Change: And they had previously done monotherapy dose escalation at much higher doses.
Speaker Change: That you can leverage your current sales force and also perhaps use in concert with our startup or how should we be thinking about what you look for.
Speaker Change: If we are currently dosing at 50 milligrams PID for days, 1% to seven and a net schedule I think they went as high as like a 100, if I remember correctly.
Speaker Change: Yeah, Ed Thanks for the question.
Speaker Change: Yes in terms of looking at assets, we always are ongoing looking at additional assets to bring in.
Somewhere in that ballpark. So we've got quite a ways to go that the drug has already been tested so I don't anticipate.
Speaker Change: Are we interested in commercial assets that we could leverage our existing sales force and could put us in a position to kind of have that channel teed up if you will for Alistair did absolutely that would be something of interest to us.
Speaker Change: We would certainly inform FDA of our decision to do that.
Speaker Change: But we wouldn't need kind of a separate meeting or would like to schedule a type C meeting or something like that for that.
Speaker Change: I apologize your last question.
Speaker Change: Just in terms of like how many doses you are thinking about exploring and how are you thinking about.
Speaker Change: So we're looking across.
Speaker Change: Cross the span if you will and Theres no question, bringing in additional commercial assets, we think would make a lot of sense.
Yeah, the data evolving in U S.
Speaker Change: You can figure out how many doses to explore.
Speaker Change: Especially if they could put us in a position.
Speaker Change: Yes, so remember that where we saw the.
Speaker Change: To kind of lay the groundwork for Alastair.
Speaker Change: Okay.
Speaker Change: The initial efficacy in terms of the subgroups with the biomarker subgroups.
Speaker Change: Okay. Thanks for taking my questions and then if I could just follow up on one question.
Speaker Change: <unk> was in the randomized trial, which was the Paclitaxel <unk> against Paclitaxel plus placebo. We continue to think that that is the approvable randomized study design.
Speaker Change: Just trying to go goes when you have that that bolus of patients is that the way we should be thinking of the sales.
Speaker Change: Sales into China in 2025 to that.
Speaker Change: One issue becomes what do we do as a monotherapy the other becomes what do you do in combination with Paclitaxel because.
Speaker Change: It's going to be.
Speaker Change: <unk> like that.
Speaker Change: Yes, and if you look historically at our sales to China, It's always been lumpy and the reason for that is that we kind of have a sale into the distribution channel kind of in that in those kind of lumpy bolus is if you will so it's always been like that quarterly and I would anticipate it would probably.
Speaker Change: Let's again I'm forecasting forward here, but let's just say for the sake of argument. We do indeed decide that there is an accelerated approval pathway available here as a mono therapy.
Speaker Change: You'd have to have that trial. The FDA rule is you have to have that trial up and running and I believe they want it almost enrolled so we kind of have to work on both of those so I think that we're looking at potentially increasing the monotherapy dose, but also in as I mentioned.
Speaker Change: <unk>, Yes, I would anticipate it would not change in 2025.
Speaker Change: Okay. Thanks for taking my questions.
Speaker Change: The next question is coming from the line of David Route with T. D. Cowen. Please proceed with your questions.
Speaker Change: In the randomized trial that was done the Paclitaxel plus al asserted they only went up to if I remember correctly 30, or 40 milligrams of <unk>.
David Route: Hey, guys. Thanks for taking my question I'll add my congrats on the initial data in lung cancer.
Speaker Change: <unk>, we would also be looking at whether or not attribute increase that as well because again, what we really wanted to do here is get us.
David Route: Just a couple of questions on that are the two patients that had a PR still on the trial.
Speaker Change: Great of a efficacy signal as we can.
David Route: The data cut and then just in terms of expanding the dose or expanding that you know the dose range potentially.
Speaker Change: And no question, if we can in a randomized trial.
Speaker Change: Positioning ourselves such that not only do we see that but a significant survival benefits that would be to our advantage as well. So I think we want to kind of look at both the monotherapy dose and the combination with paclitaxel as well.
David Route: You have to meet with the FDA before looking at <unk>.
Speaker Change: Increased Joseph I'll start and then I'll.
Speaker Change: Or are you thinking about maybe how many doses youre planning on exploring is it just one or are you trying to go are you trying to do like a sequential dose escalation I need to figure out.
Speaker Change: That's helpful. Thank you.
Speaker Change: Sure.
Speaker Change: Kind of where he can get the most out thank you.
Speaker Change: Our next question is from the line of Gena Wang with Barclays. Please proceed with your question.
Speaker Change: Yes.
Speaker Change: Thanks for the questions David.
In terms of the two patients who are.
Speaker Change: Hi, Thank you for taking our questions. This is Jenny for Ciena.
Speaker Change: With the <unk> I apologize I don't have the data in front of me. So I don't know the answer that question.
Speaker Change: Have a question about comp restaurant count.
Speaker Change: Cancer interim readout, so could you provide more color on the timeline.
With regard to the dose.
Speaker Change: You mentioned like medical meeting and then we wonder like harmony.
Speaker Change: You'll remember that we licensed this dose this drug from Takeda.
Speaker Change: And they had previously done monotherapy dose escalation at much higher doses.
Speaker Change: Is that how you would report.
Speaker Change: I think last quarter, you guys have read all the cycle fourth quarter four but why is it is postponed too.
Speaker Change: If we're currently dosing at 50 milligrams B I D for days, 1% to seven and in that schedule I think they went as high as like 100, if I remember correctly somewhere in that ballpark. So we've got quite a ways to go that the drug has already been tested so I don't anticipate.
Speaker Change: On your five.
Also like what is the kind of a benchmark.
Speaker Change: Activity. Thank you.
Speaker Change: Okay. So in terms of the litho breast, we haven't started enrolling that trial yet so once we get enrollment for that we'll have a much better.
Speaker Change: We would certainly inform FDA of our decision to do that but we wouldn't need kind of a separate meeting or would like to schedule a type C meeting or something like that for that.
Speaker Change: A better view of when we'll be able to present data. So obviously theres two ways of presenting data wanted to do it on a call like this the others had a medical meeting.
Speaker Change: In terms of your second question. We had originally said we were going to provide interim data on the eliska lung trial sometime in <unk>.
Speaker Change: I apologize your last question.
Speaker Change: Yes.
Speaker Change: Just in terms of like how many doses you are thinking about exploring and how are you thinking about.
Speaker Change: Q4 of 2024, that's what today's update once.
Speaker Change: The data evolving as you as you figure out how many doses to explore.
Speaker Change: Now in terms of full presentation at a medical meeting.
Speaker Change: That will be sometime next year that we have a steering committee they will make that decision.
Speaker Change: Yeah, So remember that where we saw the initial.
Speaker Change: In terms of what the benchmark is.
Speaker Change: Initial efficacy in terms of the subgroups the biomarker subgroups.
Speaker Change: And again, we're taking a biomarker driven approach to the development of <unk>.
Speaker Change: In the previous monotherapy trial, they didn't do a biomarker analysis. So it's hard to do a comparative view.
Speaker Change: In the randomized trial, that's where they did do the biomarker analysis and Thats, where the signals popped up.
Speaker Change: Having PFS benefit and potentially I believe OLED benefits.
In the patients with the <unk> gains.
Speaker Change: And the.
Speaker Change: <unk> mutations.
Speaker Change: In terms of our current trial again I don't have the data in front of me, but if I remember correctly there were more patients in the.
Speaker Change: <unk> resistant refractory group.
That had biomarkers that were associated with Aurora kinase activity than in the chemotherapy sensitive group. So I'm hypothesizing that that's why we're seeing that difference in activity.
Speaker Change: We had previously seen with Alice <unk> much.
Speaker Change: Much better activity in the chemotherapy resistant refractory and that was both in Mi.
Monotherapy trial that was done and published in lancet oncology and in a randomized trial in the journal of thoracic oncology.
Speaker Change: Again, I don't have the data in front of me, but if I remember this correctly in the chemo.
Speaker Change: Therapy resistant refractory group in our list along I believe there was five patients that had a had RB one mutations and gain whereas in the chemotherapy sensitive group I believe it was only one again I don't have the data in front of me that's kind of top of my head.
So again, if what we're seeing is two responders out of five that had those biomarkers, yes, I think that puts us in a decent position.
Speaker Change: But again I'm just speculating on that obviously theres no.
Speaker Change: They didn't do that in the previous study so there's nothing to compare to and to my knowledge.
Speaker Change: No one has.
Speaker Change: Developed at a drug looking at the Aurora kinase pathway in these biomarkers.
Speaker Change: Okay. Thank you.
Speaker Change: Thank you this.
Speaker Change: This concludes our question and answer session I would like to turn the conference back to Maryann for closing remarks.
Speaker Change: Thank you for joining us today as a reminder, this call may be accessed via replay at on the biotechnology Dot com. Beginning later today have a good evening.
Speaker Change: Ladies and gentlemen, thank you for participating in today's conference call. This concludes our program everyone have a great day you may now disconnect.