Q2 2024 Puma Biotechnology Inc Earnings Call

Diego: Good afternoon. My name is Diego and I will be your conference call operator today.

Operator: At this time, all participants are in a listen-only mode. After the speaker's formal remarks, there will be a question and answer session; please press star zero. I would now like to turn the call over to Mariann Ohanesian.

Operator: At this time, all participants are in a listen-only mode.

Operator: After the speaker's formal remarks, there will be a question-and-answer session. If you would like to ask a question during that time, simply press the star key, then the number one on your telephone keypad. If you would like to withdraw your questions, please press star two. If you should require operator assistance during the conference, please press star zero.

Diego: At this time, all participants are in a listen-only mode.

Speaker Change: After the speaker's formal remarks, there will be a question and answer session. If you would like to ask a question during that time, simply press the star key, then the number 1 on your telephone keypad. If you would like to withdraw your questions, please press star 2.

Speaker Change: If you should require operator assistance during the conference, please press star 0. As a reminder, this conference is being recorded.

Operator: As a reminder, this conference is being recorded.

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

Speaker Change: I would now like to turn the call over to Mariann Ohanesian.

Mariann Ohanesian: Senior Director of IR for Puma Biotechnology. You may begin your conference.

Mariann Ohanesian: Thank you, Diego. Good afternoon and welcome to Puma's conference call to discuss our financial results for the second quarter of 2024. Joining me on the call today are Alan Auerbach, Chief Executive Officer, President, and Chairman of the Board of Technology. Maximum No Gas, Chief Financial Officer, and Jeff Ledwood, Chief Commercial Officer.

Mariann Ohanesian: Thank you, Diego. Good afternoon and welcome to Puma's conference call to discuss our financial results for the second quarter of 2024.

Mariann Ohanesian: Aftermarket close today, Puma issued a news release detailing second quarter of 2024 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 sections of our website at PumaBioTechnology.com. The webcast and presentation slides will be archived on our website and available for replay for the next 90 days.

Speaker Change: After market close today, Puma issued a news release detailing second quarter 2024 financial results.

Speaker Change: That news release, the slides that Jeff will refer to, and a webcast of this call are accessible via the homepage and investor sections of our website at Pumabiotechnology.com.

Jeff: The webcast and presentation slides will be archived on our website and available for replay for the next 90 days.

Mariann Ohanesian: Today's conference call will include statements about Puma's future expectations, plans, and prospects that constitute forward-looking statements for purposes of federal securities laws. Such statements are subject to risk and uncertainties, and actually, ransom results may differ from those expressed in these forward-looking statements. For a full discussion of these risks and uncertainties, please review our periodic and current reports filed with the SEC from time to time, including our annual report on Form 10-K for the year end of December 31, 2023. 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, August 1, 2024.

Jeff: Today's conference call will include statements about Puma's future expectations, plans, and prospects that constitute forward-looking statements for purposes of federal securities laws.

Alan Auerbach: Such statements are subject to risk and uncertainties, and actual events and results may differ from those expressed in these forward-looking statements. Please refer to our second quarter 2024 news release for a reconciliation of our GAP to non-GAP results. I will now turn the call over to Alan.

Jeff: Such statements are subject to risk and uncertainties, and actual events and results may differ from those expressed in these forward-looking statements.

Jeff: 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.

Jeff: 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, August 1st, 2024.

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

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

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 they supplement to but not as a substitute for our GAAP financial measures. Please refer to our second quarter of 2024 news release for a reconciliation of our GAAP to non-GAAP results.

Jeff: 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.

Jeff: Please refer to our second quarter 2024 news release for a reconciliation of our GAP to non-GAP results. I will now turn the call over to Alan.

Alan Auerbach: I will now turn the call over to Alan. Thank you, Meridan, and thank you all for joining our call today. Today, Puma reported total revenue for the second quarter of 2024 of $47.1 million. That total revenue includes product revenue net, which consists entirely of near-link sales, as well as royalties from our sublicenses. Product revenue net was $44.4 million in the second quarter of 2024, which was an increase from the $40.3 million reported in Q1 of 2024, and below the $51.6 million reported in Q2 of 2020.

Alan Auerbach: Today, Puma reported total revenue for the second quarter of 2024 of $47.1 million. Total revenue includes product revenue net, which consists entirely of Neuralink sales, as well as royalties from our sub-licenses.

Alan: Thank you, Mariann, and thank you all for joining our call today.

Alan: Today, Puma reported total revenue for the second quarter of 2024 of $47.1 million.

Alan: Total revenue includes product revenue net, which consists entirely of Neuralink sales, as well as royalties from our sub-licensees.

Speaker Change: Product revenue net was $44.4 million in the second quarter of 2024, which was an increase from the $40.3 million reported in Q1 of 2024, and below the $51.6 million reported in Q2 of 2023.

Alan Auerbach: 3. Product revenue for the second quarter of 2024 was impacted by approximately 2.3 million of inventory drawdown in our specialty pharmacies and specialty distributors. Royalty revenue was 2.7 million in the second quarter of 2024 compared to 3.5 million in Q1 of 2024 and 3.0 million in Q2 of 2023. We reported 2,515 bottles of narrow-linked sold in the second quarter of 2024, an increase of 105 bottles from the 2,410 bottles sold in Q1 of 2024. In Q2 of 2024, we estimate that inventory decreased by about 132 bottles. In Q2 of 2024, new prescriptions were down approximately 9% compared to Q1 of 2024, and total prescriptions were up approximately 3% compared to Q1 of 2024.

Alan Auerbach: Product revenue for the second quarter of 2024 was impacted by approximately $2.3 million of inventory drawdown in our specialty pharmacies and specialty distributors. In Q2 2024, we estimate that inventory decreased by about 132 boxes. I will now provide a clinical review of the quarter, and then Jeff Ludwig will add additional color on New York's commercial activities. Maximo Nougues will follow with highlights of the key components of our financial statements for the first quarter of 2024.

Speaker Change: Product revenue for the second quarter of 2024 was impacted by approximately 2.3 million of inventory drawdown in our specialty pharmacies and specialty distributors.

Speaker Change: Royalty revenue was $2.7 million in the second quarter of 2024 compared to $3.5 million in Q1 of 2024 and $3.0 million in Q2 of 2023.

Speaker Change: We reported 2,515 bottles of Neuralink sold in the second quarter of 2024, an increase of 105 bottles from the 2,410 bottles sold in Q1 2024.

Speaker Change: In Q2 2024, we estimate that inventory decreased by about 132 bottles.

Speaker Change: In Q2 2024, new prescriptions were down approximately 9% compared to Q1 2024, and total prescriptions were up approximately 3% compared to Q1 of 2024.

Alan Auerbach: Jeff will provide further details in his comments and slides. I will now provide a clinical review of the quarter, and then Jeff Ludwig will add additional color on New Orleans commercial activities. Maximo Nougues will follow with highlights of the key components of our financial statements for the first quarter of 2024. As we have previously discussed, Puma has initiated a phase two study of our investigational drug allocertive to confirm the efficacy of allocertive monotherapy in patients with small cell lung cancer with biomarkers where a rare kinase pathway plays a role. 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 Paclitexyl plus alicertive versus Paclitexyl plus placebo that was published in the Journal of the RASICON College in 2020.

Jeff Ludwig: Jeff will provide further details in his comments and slides. I will now provide a clinical review of the quarter and then Jeff Ludwig will add additional color on New Orleans commercial activities. Maximo Nougues will follow with highlights of the key components of our financial statements for the first quarter of 2024.

Speaker Change: As we have previously discussed, Puma has initiated a Phase II study of our investigational drug alisertive to confirm the efficacy of alisertive monotherapy in patients with small cell lung cancer with biomarkers where aurora kinase pathway plays a role.

Alan Auerbach: 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 Paclitaxel plus alicertib versus Paclitaxel plus placebo that was published in the Journal of Thoracic Oncology in 2012. The safety results from the study showed that 37% of the patients experienced grade 3, 4 neutropenia, 17% experienced grade 3, 4 anemia, 13% experienced grade 3, 4 leukopenia, and 10% experienced grade 3, 4 thrombocytopenia.

Speaker Change: The goal is to correlate the efficacy in these biomarker subgroups in the ELISCA Lung 1 study.

Speaker Change: to the efficacy that was previously seen in the biomarker subgroups from the randomized trial of Paclitaxel plus alisertib versus Paclitaxel plus placebo that was published in the Journal of Thoracic Oncology in 2020.

Alan Auerbach: If the efficacy and biomarker data are comparable from the two studies, the company believes it could represent a potential accelerated approval strategy and would engage the FDA to discuss this further. As investors will remember, alicertive was previously tested as a monotherapy in patients with small cell lung cancer, and the results of this trial were published in Lansing on Ecology in 2015. In this trial, alicertive was administered as a monotherapy to 48 patients with small cell lung cancer. The safety results from the study showed that 37% of the patients experienced grade 3, 4 neutropenia; 17% experienced grade 3, 4 anemia; 13% experienced grade 3, 4 leukopenia; and 10% experienced grade 3, 4 thrombocytopenia. Additionally, 13 patients discontinued treatment due to adverse events.

Speaker Change: If the efficacy and biomarker data are comparable from the two studies, the company believes it could represent a potential accelerated approval strategy and would engage FDA to discuss this further.

Speaker Change: As investors will remember, aliceratib 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.

Speaker Change: In this trial, L-Assertive was administered as a monotherapy to 48 patients with small cell lung cancer.

Speaker Change: The safety results from the study showed that 37% of the patients experienced grade 3, 4 neutropenia.

Speaker Change: 17% experienced grade 3-4 anemia, 13% experienced grade 3-4 leukopenia, and 10% experienced grade 3-4 thrombocytopenia. And 13 patients discontinued treatment due to adverse events.

Alan Auerbach: And 13 patients discontinued treatment due to adverse events. There are currently 12 patients enrolled in the ELISCA Lung 1 trial, with several in screening and pre-screening. We anticipate that we will be able to share interim data from this trial with investors in late 2024, which will be published in JAMA Oncology in 2022. We anticipate initiating the ELISCA breast one study, a phase two trial of Alisertib in combination with endocrine treatment in patients with chemotherapy-naive, HER2 negative, hormone receptor positive metastatic breast cancer in Q4 of 2024. More specifically, patients with metastatic EGFR mutant non-small cell lung cancer are treated with osomertinib, and then at the time of progression, alacertinib is added to osomertinib in order to see if alacertinib can overcome osomertinib resistance.

Alan Auerbach: It is believed that these adverse events are due to the alicertive mechanism of action as a cell cycle inhibitor. The efficacy results from the trial showed that for the 36 chemotherapy-sensitive patients, the objective response rate was 19%, and the PFS was 2.8 months; and for the 12 chemotherapy-resistant or relapsed patients, the objective response rate was 25% with a PFS of 1.4 months. When Puma licensed alicertive, we stated that one of the 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 alicertive.

Speaker Change: It is believed that these adverse events are due to the allosertive mechanism of action as a cell cycle inhibitor.

Speaker Change: The efficacy results from the trial showed that for the 36 chemotherapy sensitive patients, the objective response rate was 19% and the PFS was 2.8 months.

Speaker Change: for the 12 chemotherapy resistant or relapsed patients the objective response rate was 25% with a PFS of 1.4 months.

Puma: When Puma licensed Alisertib, we stated that one of the 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.

Alan Auerbach: This is being instituted in the Alisco Lung 1 trial, and we look forward to seeing the results of this trial to better assess whether or not the prophylactic use of GCSF improved the adverse event profile of the drug. We will also be looking at the efficacy of allocertive in the Elyscal-1 trial and more specifically we will be looking at response rate and PFS both by type of relapse after treatment, sensitive versus resistive refractory and by small cell lung cancer molecular subtype ASCL-1, Nero-D-1, POU-2, F3 and YAP-1. As mentioned previously, we will be also be performing a biomarker analysis on the patients in the Elyscal-1 study, among one study, in order to see if the efficacy of allocertive monotherapy in patients with small cell lung cancer correlates with biomarkers with error kinase pathway plays the role.

Speaker Change: This is being instituted in the ELISCO Lung 1 trial and we look forward to seeing the results of this trial to better assess whether or not the prophylactic use of GCSF improved the adverse event profile of the drug.

Speaker Change: We'll also be looking at the efficacy of L-Assertive in the ELISCO-1 trial, ELISCO-Lung-1 trial, and more specifically we'll be looking at response rate and PFS.

Speaker Change: both by type of relapse after treatment, sensitive versus resistant refractory, and by small cell lung cancer molecular subtype, ASCL1, NeuroD1, POU2F3, and YAP1.

Speaker Change: As mentioned previously, we will also be performing a biomarker analysis on the patients in the ELISCO-1 study, Lung-1 study.

Speaker Change: in order to see if the efficacy of L-assertive monotherapy in patients with small cell lung cancer correlates with biomarkers where the aurora kinase pathway plays a role.

Alan Auerbach: There are currently 12 patients enrolled in the Elyscal-1 trial, with several in screening and prescreening.

Speaker Change: There are currently 12 patients enrolled in the ELISCA Lung 1 trial, with several in screening and prescreening.

Alan Auerbach: We anticipate that we will be able to share interim data from this trial with investors in the late 2024. In addition to clinical presentations on allocertive, we are made at the 2024 ASCO Annual Meeting in early June. Investors will remember that the Phase 2 trial referred to as TBCRC-41, which was a Phase 2 trial of allocertive monotherapy versus allocertive plus endocrine therapy in patients with HER2-negative hormone receptor-positive metastatic breast cancer, which was published in Gemma Oncology in 2023. As part of this trial, an analysis of biomarkers was performed in order to determine if the efficacy of allocertive in patients with HER2-negative hormone receptor-positive metastatic breast cancer correlates with any biomarkers.

Speaker Change: We anticipate that we will be able to share interim data from this trial with investors in late 2024.

Speaker Change: In addition, two clinical presentations on Alicertib were made at the 2024 ASCO annual meeting in early June .

Speaker Change: Investors will remember that the phase 2 trial referred to as TBCRC 41, which was a phase 2 trial of allosertive monotherapy versus allosertive plus endocrine therapy in patients with HER2 negative, hormone receptor positive, metastatic breast cancer.

Speaker Change: which was published in JAMA Oncology in 2023.

Speaker Change: As part of this trial, an analysis of biomarkers was performed in order to determine if the efficacy of alacertib in patients with HER2-negative, hormone receptor-positive metastatic breast cancer correlates with any biomarkers.

Alan Auerbach: Some of the biomarker data from the trial was presented on a poster at the 2024 ASCO Annual Meeting.

Speaker Change: Some of the biomarker data from this trial was presented on a poster at the 2024 ASCO annual meeting.

Alan Auerbach: We anticipate the initiation of the Elisca Breast-1 study, a Phase 2 trial of allocertive in combination with endocrine treatment in patients with chemotherapy-naive HER2-negative hormone receptor-positive metastatic breast cancer in Q4 of 2024. In addition, there is an ongoing investigator-sponsored trial of allocertinib given in combination with osimertinib in 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 osamertinib, and then at the time of progression, allocertive is added to osamertinib in order to see if allocertive can overcome osamertinib resistance. In term, data on this trial was previously presented in ASCO prior to Puma licensing the stroke.

Speaker Change: We anticipate the initiation of the ELISCA breast 1 study, a phase 2 trial of alicertib in combination with endocrine treatment in patients with chemotherapy naive HER2 negative hormone receptor positive metastatic breast cancer in Q4 of 2024.

Speaker Change: In addition, there is an ongoing investigator-sponsored trial of alisertib given in combination with osimertinib 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 osomertinib, and then at the time of progression, alicertinib is added to osomertinib in order to see if alicertinib can overcome osomertinib resistance.

Speaker Change: Interim data on this trial was previously presented at ASCO prior to Puma licensing this drug.

Alan Auerbach: Updated data from this trial was presented as a poster presentation at the 2024 ASCO Annual Meeting. For the 21 evaluable patients, the investigator assessed overall response rate was 9.5%, and the disease control rate was 81%. The median PFS for all patients was 5.5 months, while the median OS was 23.5 months. For patients with T-53 mutations, N equals 9, the overall response rate was 0%, and the disease control rate was 66.7%. For the patients who were T-53 wild type, which was 8 patients, the overall response rate was 25%, and the disease control rate was 87.5%. For patients with T-P53 mutations, progression-free survival was 3.7 months.

Alan Auerbach: Updated data from this trial was presented as a poster presentation at the 2024 ASCO Annual Meeting. For the 21 invaluable patients, the investigator-assessed overall response rate was 9.5%, and the disease control rate was 81%. The median PFS for all patients was 5.5 months, while the median OS was 23.5 months. The overall response rate was 0%, and the disease control rate was 66.7%.

Speaker Change: Updated data from this trial was presented as a poster presentation at the 2024 ASCO annual meeting.

Speaker Change: For the 21 evaluable patients, the investigator-assessed overall response rate was 9.5%, and the disease control rate was 81%.

Speaker Change: The median PFS for all patients was 5.5 months, while the median OS was 23.5 months.

Speaker Change: For patients with TP53 mutations, N equals 9, the overall response rate was 0% and the disease control rate was 66.7%.

Alan Auerbach: For the patients who were T53 wild type, which was 8 patients, the overall response rate was 25%, and the disease control rate was 87.5%. For patients with TP53 mutations, progression-free survival was 3.7 months. For patients who are T53 wild type, the progression fee survival was 8 months. The hazard ratio for PFS was 0.42 with a p-value of 0.05. Based on these interim results, the trial has been amended such that it will limit future enrollment in the trial to patients who are TP53 wild. The company will keep investors updated on this as it progresses.

Speaker Change: For the patients who were T53 wild type, which was 8 patients, the overall response rate was 25% and the disease control rate was 87.5%.

Speaker Change: For patients with TP53 mutations, the progression fee survival was 3.7 months. For patients who are T53 wild type, the progression fee survival was 8 months.

Alan Auerbach: For patients who are T-P53 wild type, the progression-free survival was 8 months. The hazard ratio for PFS was 0.42 with a p-value of 0.05. Based on these interim results, the trial has been amended so that it's such that it will limit future enrollment in the trial to patients who are T-P53 wild type.

Speaker Change: The hazard ratio for PFS was 0.42 with a p-value of 0.05.

Speaker Change: Based on these interim results, the trial has been amended such that it will limit future enrollment in the trial to patients who are TP53 wild type.

Alan Auerbach: We look forward to updating investors on this data in the future. As previously mentioned, on prior earnings calls and in response to investor questions, Puma continues to evaluate several drugs to potentially in-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.

Speaker Change: We look forward to updating investors on this data in the future.

Speaker Change: As previously mentioned, on prior earnings calls and in response to investor questions, Puma continues to evaluate several drugs to potentially end license.

Speaker Change: that would allow the company to diversify itself and leverage Puma's existing R&D, regulatory, and commercial infrastructure.

Jeffrey Ludwig: I will now turn the call over to Jeff Ludwig, who is Chief Commercial Officer, for a review of our commercial performance during the quarter. Thanks, Alan. I appreciate it, and thanks to everyone for joining our second quarter earnings call. Before I move into the commercial review, just a reminder that I will be making forward-looking statements.

Speaker Change: 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.

Jeff Ludwig: Thanks Alan, appreciate it and thanks to everyone for joining our second quarter earnings call. Before I move into the commercial review, just a reminder that I will be making forward-looking statements.

Jeffrey Ludwig: Let me start out by reiterating our strategy. The commercial team remains largely focused on the extended adjuvant indication, where the majority of sales and opportunity exist. Our commercial messaging is focused on her two positive patients that are deemed to be at higher risk of reoccurrence. A significant portion of these early-stage breast cancer patients are treated in the community oncology setting and are being seen across a large number of community oncologists. Given this distribution of patients, our sales and marketing teams are focused on efficiently increasing region frequency for both personal and non-personal promotion, with an emphasis on trying to reach customers when decisions are being made for the extended adjuvant setting.

Jeff Ludwig: Let me start out by reiterating our strategy. The commercial team remains largely focused on the extended adjuvant indication where the majority of knurling sales and opportunity exist.

Jeff Ludwig: Our commercial messaging is focused on HER2-positive patients that are deemed to be at higher risk of reoccurrence.

Jeff Ludwig: A significant portion of these early stage breast cancer patients are treated in the community oncology setting and are being seen across a large number of community oncologists.

Jeff Ludwig: Given this distribution of patients, our sales and marketing teams are focused on efficiently increasing reach and frequency for both personal and non- personal promotion, with an emphasis on trying to reach customers when decisions are being made for the extended adjuvant setting.

Jeffrey Ludwig: HCP calls in the second quarter increased about 6% quarter of a quarter, but declined about 8% year-over-year. The year-over-year decline was driven by the timing of vacancies. In the second quarter, greater than 80% of calls relive interactions. We are continuing to evaluate new data and vendor partners that will allow us to operate more efficiently and effectively, with the goal of balancing the needs of knurlings with the goals of the broader organization.

Speaker Change: HCP calls in the second quarter increased about 6% quarter over quarter, but declined about 8% year over year. The year over year decline was driven by the timing of vacancies.

Alan Auerbach: In the second quarter, greater than 80% of calls were live interactions. We are continuing to evaluate new data and vendor partners that would allow us to operate more efficiently and effectively with the goal of balancing the needs of Neuralinks with the goals of the broader organization. Slide 3 provides an overview of our distribution model. This model has not changed and remains separated into two distinct channels, the specialty pharmacy channel and the specialty distributor channel or in-office dispensing channel.

Speaker Change: In the second quarter, greater than 80% of calls were live interactions. We are continuing to evaluate new data and vendor partners that would allow us to operate more efficiently and effectively with the goal of balancing the needs of Neuralinks with the goals of the broader organization.

Jeffrey Ludwig: Let me transition now into some of the commercial slides, where I will provide some additional specifics around performance.

Speaker Change: Let me transition now into 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.

Jeffrey Ludwig: Once I have finished, I will turn the call over to Maximo for a more detailed review of our financial results.

Jeffrey Ludwig: Slide 3 provides an overview of our distribution model. This model has not changed and remains separated into two distinct channels: the specialty pharmacy channel and the specialty distributor channel, or in-office dispensing channel. We do typically see quarterly fluctuations, but the majority of our business flows through the specialty pharmacy channel. In Q2, about 72% of our business went through the specialty pharmacy channel, and the remaining 28% went through the specialty distributor channel. As a comparison, in Q1, we reported about 74% of our business going through the specialty pharmacy channel and the remaining 26% of our business going through the specialty distributor channel.

Alan Auerbach: In Q2, about 72% of our business went through the specialty pharmacy channel, and the remaining 28% went through the specialty distributor channel. NeurLink's net revenue in Q2 was $44.4 million, which is a $4.1 million increase from the $40.3 million we reported in Q1 of 2024 and a $7.2 million decrease from the $51.6 million we reported in Q2 of 2023. As a comparison, we estimate that inventory decreased by about $2 million in Q1 and decreased by about $1.5 million in Q2 of 2023.

Maximo: Slide 3 provides an overview of our distribution model. This model has not changed and remains separated into two distinct channels, the specialty pharmacy channel and the specialty distributor channel or in-office dispensing channel.

Maximo: We do typically see quarterly fluctuations, but the majority of our business flows through the specialty pharmacy channel.

Maximo: In Q2, about 72% of our business went through the specialty pharmacy channel, and the remaining 28% went through the specialty distributor channel.

Maximo: As a comparison, in Q1 we reported about 74% of our business going to the specialty pharmacy channel and the remaining 26% of our business going to the specialty distributor channel.

Jeffrey Ludwig: Journal. Turning to slide 4, NERLINK's net revenue in Q2 was $44.4 million, which is a $4.1 million increase from the $40.3 million we reported in Q1 of $24, and a $7.2 million decrease from the $51.6 million we reported in Q2 of 2023. Inventory changes will impact these comparisons, so let me provide some additional information. In Q2 of 2024, we estimated inventory decrease by about $2.3 million. As a comparison, we estimated inventory decrease by about $2 million in Q1 and decreased by about $1.5 million in Q2 of 2023. Slide 5 shows Q2 24x factory bottle sales and also provides both a year-over-year and a quarter-over-quarter comparison.

Maximo: Turning to slide 4.

Maximo: NeurLink's net revenue in Q2 was $44.4 million, which is a $4.1 million increase.

Maximo: from the $40.3 million we reported in Q1 of 2024 and a $7.2 million decrease from the $51.6 million we reported in Q2 of 2023.

Maximo: Inventory changes will impact these comparisons, so let me provide some additional information.

Maximo: In Q2 of 2024, we estimate that inventory decreased by about 2.3 million.

Maximo: As a comparison, we estimate that inventory decreased by about 2 million in Q1 and decreased by about 1.5 million in Q2 of 2023.

Maximo: Slide 5 shows Q224X factory bottle sales and also provides both a year-over-year and a quarter-over-quarter comparison.

Jeffrey Ludwig: In Q2 of 24, NERLINK's X factory bottle sales were $2,515, which represents a 4% quarter-over-quarter increase and a 17% year-over-year decline. Let me again provide more specifics around inventory changes. We estimate that inventory decreased by about 132 bottles in the second quarter of 2024. As a comparison, we estimate that inventory decreased by about 121 bottles in Q1 of 24 and decreased by about 90 bottles in Q2 of 2023.

Speaker Change: In Q2 of 24, Neuralink's X-Factory bottle sales were 2,515, which represents a 4% quarter-over-quarter increase and a 17% year-over-year decline.

Maximo: Let me again provide more specifics around inventory changes.

Maximo: We estimate that inventory decreased by about 132 bottles in the second quarter of 2024.

Alan Auerbach: As a comparison, we estimate that inventory decreased by about 121 bottles in Q1 of 24 and decreased by about 90 bottles in Q2 of 23, in terms of total prescriptions or TRX. As a reminder, this pattern occurs as some patients delay starting therapy in the fourth quarter to avoid side effects around the holidays. This pattern decreases enrollments in the fourth quarter but subsequently increases enrollments in the first quarter. The team remains passionate about making a difference in the lives of patients and their families battling cancer.

Maximo: As a comparison, we estimate that inventory decreased by about 121 bottles in Q1 of 24 and decreased by about 90 bottles in Q2 of 23.

Jeffrey Ludwig: Now let me share some additional metrics in insight into our second quarter performance. In Q2, we saw new patient starts or NERX decreased by about 9% quarter-over-quarter and declined about 10% year-over-year. In terms of total prescriptions or TERX, we saw a 3% increase quarter-over-quarter and a 14% decline year-over-year. Overall demand increased in the second quarter by about 5% quarter-over-quarter and declined about 15% year-over-year. Q2 performance was negatively impacted by the decline in enrollments we discussed in our Q3 and Q4 earnings call. As a reminder, we saw increased softness in enrollments that largely occurred in the first part of Q3 last year.

Maximo: Now let me share some additional metrics and insights into our second quarter performance.

Maximo: In Q2, we saw new patient starts, or NRX, decrease by about 9% quarter over quarter and decline about 10% year over year.

Maximo: In terms of total prescriptions, or TRX, we saw a 3% increase quarter over quarter and a 14% decline year over year.

Maximo: Overall, demand increased in the second quarter by about 5% quarter over quarter and declined about 15% year over year.

Maximo: Q2 performance was negatively impacted by the decline in enrollments we discussed in our Q3 and Q4 earnings call.

Maximo: As a reminder, we saw increased softness in enrollments that largely occurred in the first part of Q3 last year.

Jeffrey Ludwig: Enrollments are obviously an important leading indicator, as enrollments turn into new patient starts and new patient starts turn into refills, which impacts demand in subsequent quarters. In Q2, enrollments decreased about 5% quarter-over-quarter and about 11% year-over-year. The second quarter-over-quarter decline follows the typical pattern we see with enrollments growing in Q1 quarter-over-quarter, which we saw this year, but then declining quarter-over-quarter in Q2. As a reminder, this pattern occurs as some patients delay starting therapy in the fourth quarter to avoid side effects around the holidays. This pattern decreases enrollments in the fourth quarter but subsequently increases enrollments in the first quarter.

Maximo: Enrollments are obviously an important leading indicator as enrollments turn into new patient starts and new patient starts turn into refills which impacts demand in subsequent quarters.

Maximo: In Q2, enrollments decreased about 5% quarter-over-quarter and about 11% year-over-year.

Maximo: The second quarter, quarter over quarter decline, follows the typical pattern we see with enrollments, growing in Q1 quarter over quarter, which we saw this year, but then declining quarter over quarter in Q2.

Maximo: As a reminder, this pattern occurs as some patients delay starting therapy in the fourth quarter to avoid side effects around the holidays. This pattern decreases enrollments in the fourth quarter, but subsequently increases enrollments in the first quarter.

Jeffrey Ludwig: Enrollments remain at top priority, and the team is focused on improving the year-over-year enrollment comparisons. Turning to slide 6. Slide 6 highlights the quarterly adoption of dose escalation since NERLINK's launch. In Q2, approximately two-thirds of patients started nerve links that are reduced dose. This is similar to what we reported in Q1 of this year. The benefits of utilizing dose escalation to initiate therapy with nerve links continues to be an important part of our commercial messaging. The control trials showed a significant reduction in grade 3 diarrhea and improved persistence in compliance when patients were started at a lower dose.

Maximo: Enrollments remain a top priority and the team is focused on improving the year-over-year enrollment comparisons.

Maximo: Turning to slide 6.

Maximo: Slide 6 highlights the quarterly adoption of dose escalation since Neuralink's launch.

Maximo: In Q2, approximately two-thirds of patients started NeurLynx at a reduced dose. This is similar to what we reported in Q1 of this year.

Maximo: The benefits of utilizing dose escalation to initiate therapy with Neuralinks continues to be an important part of our commercial messaging. The control trial showed a significant reduction in grade 3 diarrhea and improved persistence and compliance when patients were started at a lower dose.

Jeffrey Ludwig: We track multiple cohorts of patients and do see improved compliance when patients are started using dose escalation.

Maximo: We track multiple cohorts of patients and do see improved compliance when patients are started using dose escalation.

Jeffrey Ludwig: Slide 7 highlights these strategic collaborations we have formed across the globe. In Q2, nerve links received regulatory approval in Brazil in the metastatic setting and regulatory approval in Saudi Arabia in the extended adjuvant setting. In addition, nerve links was just recently launched in South Africa, also in the extended adjuvant setting. We truly appreciate the work being done by our partners and look forward to supporting their continued success moving forward.

Maximo: Slide 7 highlights the strategic strategic collaborations we have formed across the globe.

Maximo: In Q2, Neuralinks received regulatory approval in Brazil in the metastatic setting and regulatory approval in Saudi Arabia in the extended adjuvant setting.

Maximo: In addition, Neuralinks was just recently launched in South Africa, also in the extended adjuvant setting.

Maximo: We truly appreciate the work being done by our partners and look forward to supporting their continued success moving forward.

Jeffrey Ludwig: I'd like to wrap up by thanking my Puma colleagues for their dedication. The team remains passionate about making a difference in the lives of patients and their families battling cancer. We are committed to being more efficient and effective with the resources, and also committed to balancing the short-term and long-term priorities of Puma and its shareholders.

Speaker Change: I'd like to wrap up by thanking my Puma colleagues for their dedication. The team remains passionate about making a difference in the lives of patients and their families battling cancer.

Maximo: We are committed to being more efficient and effective with our resources and also committed to balancing the short-term and long-term priorities of Puma and its shareholders.

Maximo Nougues: I will now turn a call over to Maximo for a review of our financial results. Maximo? Thanks, Jeff.

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

Maximo Nougues: I will begin with a brief summary of our financial results for the second quarter of 2024. Please note that I will make comparisons to Q1 2024, which we believe is a better indication of our progress as a commercial company and year-over-year comparisons.

Maximo: Thanks Jeff. I will begin with a brief summary of our financial results for the second quarter of 2024.

Maximo: Please note that I will make comparisons to Q1 2024, which we believe is a better indication of our progress as a commercial company than year-over-year comparisons.

Maximo Nougues: For more information, I recommend that you refer to our Q2 Thank You, which we've refiled today and includes our consolidated financial statements. With the second quarter of 2024, we reported a net loss based on GAAP of 4.5 million or 9 cents per share. This compares to a net loss in Q1 2024 of 4.8 million, or 10 cents per share. On a non-gap basis, which is adjusted to remove the impact of stock-based compensation expense, we reported a net loss of 2.5 million, or 5 cents per share, for the second quarter of 2024. Our revenue from NELIC sales was 55.8 million in Q2 2024 and 52.6 million in Q1 2024.

Speaker Change: For more information, I recommend that you refer to our Q2 Thank You, which we refiled today and includes our consolidated financial statements.

Maximo: In the second quarter of 2024, we reported a net loss based on GAAP of $4.5 million, or $0.09 per share.

Speaker Change: This compares to a net loss in Q1 2024 of $4.8 million or $0.10 per share.

Speaker Change: On a non-GAAP basis, we just adjusted to remove the impact of stock-based compensation expense.

Speaker Change: We reported a net loss of $2.5 million, or $0.05 per share, for the second quarter of 2024.

Speaker Change: Gross revenue from nailing sales was $55.8 million in Q2 2024 and $52.6 million in Q1 2024.

Maximo Nougues: As Alan mentioned, net product revenue from NELIC sales was 44.4 million and improvements from the 40.3 million reported in Q1 2024. Higher demand and lower gross net adjustments dropped the higher sales versus Q1 2024. Inventory drawdown by our distributors was approximately 2.3 million in Q2 versus approximately 2 million of drawdown in Q1 2024. Prior to revenue, totaled 2.7 million in the second quarter of 2024 compared to 3.5 million in Q1 2024. Our gross net adjustment in Q2 2024 was about 20.4%, compared to the 23.4% gross net adjustment reported in Q1 2024. Lower Medicaid share, coverage gap, and lower copae were the main drivers of the decline versus Q1-2024 Coftos cells for Q2-2024 was 10.7 million including 2.4 million for the mortisation of intangible assets related to our narrative license Coftos cells for Q1-2024 was also 10.7 million.

Speaker Change: As Alan mentioned, net product revenue from Netlix sales was $44.4 million, an improvement from the $40.3 million reported in Q1 2024.

Maximo Nougues: Higher Demand and Lower Gross Net Adjustments drop higher sales versus Q1 2024; lower Medicaid share, coverage gap, and lower co-pay were the main drivers of the decline versus Q1 2020. Going forward, we will continue to recognize amortization of milestones to the licensure of about $2.4 million per quarter as cost of sale. For fiscal year 2024, Puma continues to anticipate that Net Nerling's product revenue will be in the range of $183 to $190 million.

Alan: Higher Demand and Lower Gross Net Adjustments drop the higher sales versus Q1 2024.

Alan: Inventory drawdown by our distributors was approximately 2.3 million in Q2 versus approximately 2 million of drawdown in Q1 2024.

Speaker Change: Royalty Revenue total at $2.7 million in the second quarter of 2024 compared to $3.5 million in Q1 2024.

Speaker Change: Our gross net adjustment in Q2 2024 was about 20.4% compared to the 23.4% gross net adjustment reported in Q1 2024.

Speaker Change: lower Medicaid share, coverage gap, and lower co-pay were the main drivers of the decline versus Q1 2024.

Speaker Change: Coftel's sales for Q2 2024 was $10.7 million, including $2.4 million for the amortization of intangible assets related to our neratinib license.

Speaker Change: Kovtun's sales for Q1 2024 was also 10.7 million.

Maximo Nougues: Going forward, we will continue to recognize a mortisation of mass tons of the licensure of about 2.4 million per quarter X Coftos cells.

Speaker Change: Going forward, we will continue to recognize amortization of milestones to the licensure of about $2.4 million per quarter as cost of sales.

Maximo Nougues: For fiscal year 2024, Puma continues to anticipate that net net links product revenue will be in the range of 183 to 190 million. We also anticipate that our gross to net adjustment for the full year 2024 will be between 21% and 22% higher than 2023 due to the impact of the Inflation Reduction Act on higher expected Medicaid rebates. In addition, for the fiscal year 2024, we anticipate receiving royalties from our partners around the world in the range of 30 to 33 million. We expect license revenue in 2024 in the range of 1 to 2 million.

Speaker Change: For fiscal year 2024, Puma continues to anticipate that Net Nerling's product 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 2024 will be between 21% and 22%.

Speaker Change: Higher than 2023 due to the impact of the Inflation Reduction Act and higher expected Medicaid rebates.

Maximo Nougues: In addition, for the fiscal year 2024, we anticipate receiving royalties from our partners around the world in the range of $30 to $33 million. Please note that the Q3 Net Product Revenue Guidance includes almost $6 million of product sales to one of our global partners, as well as U.S. net revenue. Research and development expenses were $13.6 million in the second quarter of 2024, unchanged from the first quarter of 2024. More specifically, we anticipate SG&E expenses to decrease by 8% to 12% and R&D expenses to increase by 16% to 19% year-over-year. Our accounts receivable balance was $28.1 million. Our terms for collecting accounts receivable range between 10 and 68 days.

Speaker Change: In addition, for the fiscal year 2024, 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 $1 to $2 million.

Maximo Nougues: We also expect the net income for the full year will be in the range of 12 to 15 million. We anticipate that for Q3-2024 nelling-mex product revenue will be in the range of 50 to 53 million. Please note that the Q3 net product revenue guidance includes almost 6 million of product cells to one of our global partners, as well as US net revenue, which we expect to be in the range of 44 to 47 million. The cells to our global partners will also contribute to the large royalty revenue that we expect in Q3. We expect Q3 royalty revenues will be in the range of 20 to 22 million, and we anticipate no license revenue.

Speaker Change: We also expect that net income for the full year will be in the range of $12 to $15 million.

Speaker Change: We anticipate that for Q3 2024, Netlink's max product revenue will be in the range of $50-$53 million.

Speaker Change: Please note that the Q3 Net Product Revenue Guidance includes almost $6 million of product sales to one of our global partners, as well as U.S. net revenue, which we expect to be in the range of $44 to $47 million.

Speaker Change: The sales to our global partners will also contribute to the large royalty revenue that we expect in Q3.

Speaker Change: We expect Q3 royalty revenues will be in the range of $20 to $22 million, and we anticipate no licensed revenue.

Maximo Nougues: The further estimate that the gross to net adjustment in Q3-2024 will be approximately 18.5% to 19.5%. Puma anticipates Q3 net income between 11 and 13 million. We anticipate that Puma will be net income positive for the full year.

Speaker Change: We further estimate that the gross net adjustment in Q3 2024 will be approximately 18.5% to 19.5%.

Puma: Puma anticipates Q3 net income between $11 and $13 million.

Speaker Change: We anticipate that Puma will be netting composites for the full year.

Maximo Nougues: SG&A expenses were 25 million in the second quarter of 2024 compared to 21.8 million for the first quarter of 2024. SG&A expenses included non-cash charges for a stock-based compensation of 1.4 million for Q2-2024, down from 1.5 million in Q1-2024. Research and development expenses were 13.6 million in the second quarter of 2024. I'm changed from the first quarter of 2024. R&D expenses, including non-cash charges for stock-based compensation of 0.6 million in the second quarter of 2024, down from 0.9 million from the first quarter of 2024.

Speaker Change: As DNA expenses were $25 million in the second quarter of 2024 compared to $21.8 million for the first quarter of 2024.

Speaker Change: SG&A expenses included non-cash charges for a stock-based compensation of $1.4 million for Q2 2024, down from $1.5 million in Q1 2024.

Speaker Change: Research and development expenses were $13.6 million in the second quarter of 2024, unchanged from the first quarter of 2024.

Speaker Change: R&D Expenses

Speaker Change: including non-cash charges for stock-based compensation of $0.6 million in the second quarter of 2024, down from $0.9 million from the first quarter of 2024.

Maximo Nougues: On the expense side, Puma continues to anticipate flat total operating expenses in 2024 compared to 2023. More specifically, we anticipate SG&A expenses to decrease by 8-12% and R&D expenses to increase by 16-19% Euro-E. In the second quarter of 2024, Puma reported cash burn of approximately 10.3 mil. This compares to cash burn of approximately 11.2 million in Q1 2024. Please note that during Q2 we made our first principal loan payment of 11.1 million related to our obligation with Ethereum. As a result of this, our total outstanding principal debt balance decreased from 100 million to more approximately 89 million.

Fuman: On the expense side, Puma continues to anticipate flat total operating expenses in 2024 compared to 2023.

Speaker Change: More specifically, we anticipate SG&E expenses to decrease by 8-12% and R&D expenses to increase by 16-19% year over year.

Speaker Change: In the second quarter of 2024, Puma reported a cash burn of approximately $10.3 million.

Speaker Change: This compares to cash earned of approximately $11.2 million in Q1 2024.

Speaker Change: Please note that during Q2 we made our first principal loan payment of $11.1 million related to our obligation with Ethereum.

Speaker Change: As a result of this, our total outstanding principal debt balance decreased from $100 million to approximately $89 million.

Maximo Nougues: At June 30, 2024, we had approximately 96.8 million in cash, cash equivalents, and marketable securities, versus about 96 million at year-end 2023. Our accounts receivable balance was 28.1 million. Our accounts receivable terms range between 10 and 68 days, while our day sales outstanding are 46 days. We estimate that as of June 30, 2024, our distribution network maintains approximately three weeks of inventory.

Speaker Change: At June 30, 2024, we had approximately $96.8 million in cash, cash equivalents, and market wall securities.

Speaker Change: versus about 96 million at year-end, 2023.

Speaker Change: Our accounts receivable balance was $28.1 million. Our accounts receivable terms range between 10 and 68 days, while our day sales outstandings are 46 days.

Speaker Change: We estimate that as of June 30th, 2024, our distribution network maintained approximately three weeks of inventory.

Maximo Nougues: Overall, we continue to deploy our financial resources to focus on the commercialization of knurlings, the development of all incentive on controlling our expenses.

Speaker Change: Overall, we continue to deploy our financial resources to focus on the commercialization of Neuralinks, the development of Alicertif, and controlling our expenses.

Maximo Nougues: Thanks, Maxima. Puma senior management and cooperation with foreign 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. In the fourth quarter of 2021, we implemented a reduction in expenses with the goal of reducing expenses in order to maximize operating cash flows. We believe 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 are also a major contributor to the positive net income that the company is guiding for full year 2024.

Maximo: Thanks, Maximo.

Speaker Change: Puma Senior Management in cooperation with the Board of Directors.

Speaker Change: continues to remain focused on Nearlink sales trends in 2024 and beyond and recognizes its fiscal responsibility of the shareholders to continue to maintain positive net income.

Speaker Change: In the fourth quarter of 2021, we implemented a reduction in expenses with the goal of reducing expenses in order to maximize operating cash flows.

Alan Auerbach: We believe the positive net income that we've seen in 2023 resulted from 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 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 in the future. This concludes today's presentation. We will now turn the floor back to the operator for Q&A. Operator?

Speaker Change: We believe 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 are also a major contributor to the positive net income that the company is guiding for for full year 2024.

Maximo Nougues: The company remains committed to continuing to achieve this positive net income and will continue to reduce expenses if needed to achieve this in the future.

Speaker Change: The company remains committed to continuing to achieve this positive net income and will continue to reduce expenses if needed to achieve this in the future.

Maximo Nougues: We look forward to updating investors on this in the future.

Maximo Nougues: 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 at helping these patients during their journey, and we will continue to strive to achieve that goal.

Speaker Change: We look forward 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.

Puma: We at Puma are committed and passionate about finding more effective ways at helping these patients during their journey, and we will continue to strive to achieve that goal. This concludes today's presentation. We will now turn the floor back to the operator for Q&A. Operator?

Maximo Nougues: This concludes today's presentation.

Operator: We will now turn the floor back to the operator for Q&A. Operator. We will now begin the question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question Q. If you wish to withdraw your question, please press star two. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.

Speaker Change: We will now begin the question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. If you wish to withdraw your question, please press star 2.

Speaker Change: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.

Operator: One moment, please, while we pull for questions.

Mark Freyham: One moment, your first question comes from Mark Freyham with T.D. Cowan. Please proceed with your question.

Speaker Change: One moment please while we pull for questions.

Speaker Change: Your first question comes from Mark Frayham with TD Cowan. Please proceed with your question.

Mark Freyham: Thanks for taking my questions. It may be just on the planned disclosure around Alaska 1 in Q4 or in late in the year.

Mark Frayham: Thanks for taking my questions. Maybe just on the planned disclosure around Alaska One in Q4 or late in the year.

Mark Freyham: Mariann can just walk through things for the, I mean the granularity that we don't often see on patient enrollment and heading into it, but your 9 is not a ton of patients and maybe responsible data on just 9 patients wouldn't be the most meaningful. I know you intend to have a few more.

Speaker Change: Mariann, can you just walk through it? Thanks for the...

Mariann Ohanesian: the granularity that we don't often see on patient enrollment heading into it, but

Speaker Change: You know, nine is not a ton of patients, and maybe response data on just nine patients wouldn't be the most meaningful. I know you intend to have a few more. How kind of rigid is that?

Alan Auerbach: How can rigid is that timeline to presenting data no matter what in Q4 versus, you know, is it really in your head a number of patients that you want to get to and you're hoping that's Q4, but if it happens to be Q1, you know, you'd get, you'd push it out. That's one question.

Speaker Change: timeline to presenting data no matter what in Q4 versus, you know, is it really in your head a number of patients that you want to get to and if and you're hoping that's Q4 but if it happens to be Q1, you know, you'd get

Alan Auerbach: And then the other is just, you're sprints the latest on some of these subsets based on the genetic background. So what do we know about the outcomes for those patients on kind of standard of care and therefore, you know, how to comp your data when you do show it for those subsets? Yeah, Mark. Thanks for the question. So, first of all, Mark, there's 12 patients currently enrolled, not 9. Or 12. Yeah, 12. Yeah. And then several are in screening. So look, it's August. So, you know, if we present the data, let's say in December, obviously more time to get some more patients to, right?

Speaker Change: You'd push it out.

Speaker Change: That's one question. And then the other is just, can you just remind us of the latest on some of these subsets based on the genetic background, just what do we know about the outcomes for those patients on standard of care and therefore how to comp your data when you do show it for those subsets?

Alan Auerbach: Yeah, Mark, thanks for the question. So first of all, Mark, there are 12 patients currently enrolled, not nine. Will it be 12? Will it be 15? Don't know.

Speaker Change: Yeah, Mark, thanks for the question. So first of all, Mark, there's 12 patients currently enrolled, not nine.

Speaker Change: And then several are in screening, so look, it's August .

Speaker Change: So, you know, if we present the data, let's say, in December , obviously more time to get some more patients, too, right? So, will it be 12? Will it be 15? Don't know. I would rather be, you know...

Alan Auerbach: So, what would be 12? Will it be 15? No.

Alan Auerbach: I would rather be, you know... We obviously have the two things we're looking at. We have the safety aspect of it and the efficacy aspect. Now, in terms of the various biomarkers and subgroups, et cetera, I mentioned a lot of the genetic subgroups.

Alan Auerbach: I would rather be, you know, a good steward of shareholder capital and presented data even if early just so that people know what's happening rather than kind of just, you know, delay it until we get to some magic number or something. You know, we obviously have the, you know, two things we're looking at. We have the safety aspect of it, and the efficacy aspect of it. You know, as you'll remember in the trial that was done and published in Journal for Ask on Collegiate, which was the Pac-O-Taxle Plus Allocerv against Pac-O-Taxle placebo, you know, we would anticipate that would be our future, you know, randomized trial, you know, for full approval.

Speaker Change: a good steward of shareholder capital and and present data even if early just so that people know what's happening Rather than kind of just you know delay it till we get to some magic number or something

Speaker Change: and others.

Alan Auerbach: In that study from the safety perspective, I don't have the numbers in front of me, but, you know, it was like, whatever the strategy was, like, 30% of the patients couldn't tolerate the Pac-O-Taxle plus Allocerv combination due to neutropenia, so that obviously, you know, compromised that arm. So clearly, using the prophylactic GCSS, we can, you know, reduce the neutropenia and improve the tolerability. I would obviously, you know, think that would pertain for our favorable future randomized trial there as well. In terms of the efficacy side of it, so, you know, we mentioned the previous data in Lancet Oncology, you know, the main difference between those patients and the ones we're testing now is, at the time the Lancet Oncology study was going on, you know, IO had not really been incorporated in the standard care, so I don't think any of those patients have seen prior IO.

Alan Auerbach: All of our patients will have seen that because now that standard of care, does that change anything? I don't know why it would, but that's why you do these studies, obviously.

Alan Auerbach: Now, in terms of the various biomarkers and subgroups, et cetera, you know, I mentioned a lot of the genetic subgroups. I don't know from a regulatory perspective how much those will play a role, so that would be a future discussion with FDA. In terms of the biomarkers that we are involved in the error kind of pathway, such as CMIC, such as RB1 loss and things like that, if you go and look at the randomized study, which was the study of the Journal Thrust Oncology, PACA tax law officer against PACA tax law loan, the patients who had those biomarkers, whether it was a CMIC amplification or a RB1 loss and function mutation, my recollection is those tended to do worse than the ITT group, so that should I would perceive select for a higher risk group patients.

Speaker Change: If you go and look at the randomized study, which was the study of the <unk>.

Speaker Change: General thoracic oncology Paclitaxel I'll sure against Paclitaxel alone.

Speaker Change: Patients who were had those biomarkers, whether it was semic amplification or a <unk>.

Speaker Change: <unk> loss of function mutation.

Speaker Change: My recollection is those tended to do worse.

Speaker Change: Then you know that the the ITT group, so that should I would perceive select for a higher risk group of patients.

Mark Freyham: Okay, thank you. Thank you.

Speaker Change: Okay.

Speaker Change: Thank you.

Speaker Change: Sure.

Speaker Change: Thank you.

Operator: And this concludes our question-and-answer session.

Speaker Change: And this concludes our question and answer session I would like to turn the conference back to Mary Ann for closing remarks.

Operator: I would like to turn the conference back to Marianne for close remarks. Actually, one question just came up.

Speaker Change: One question just came up my apologies, we do have one that just came out and that question comes from Ed White with H C. Wainwright. Please state your question.

Operator: My apologies. We do have one that just came up.

Ed White: And that question comes from Ed White with H.C. Wainwright, please do your question.

Speaker Change: Yeah.

Ed White: Hi, thanks for taking my question. Just a question on sales in the U.S. Guidance is given for nearly sales. The first quarter results conference call, it was changed during the year during the quarter, and then you just recorded numbers to actually hit the original numbers. So I'm just wondering what was changing within the quarter that had to change your guidance.

Ed White: Hi, Thanks for taking my questions.

Ed White: Just a question.

Ed White: In the U S.

Ed White: Guidance was given for new Airlink sales on the first quarter results conference call. It was changed during the year during the quarter and then you just reported numbers to actually hit the original numbers. So I'm just wondering what what's changing within the quarter.

Speaker Change: To change your guidance and then the second question is.

Ed White: And then the second question is just on the royalty number. You know, you're having a huge goal was of revenues expected for royalties. In the third quarter, I'm just wondering what the reasons behind that. Thank you.

Speaker Change: On the royalty number you know you're having a huge bolus of.

Speaker Change: Revenues expected for royalties in the third quarter I'm just wondering what's the.

Speaker Change: Reasons.

Speaker Change: Thank you.

Alan Auerbach: Hi, Ed, it's Alan, and your first comment: we didn't change our Q1 revenue guidance for near links. Can you clarify that? We have no; we're all looking at each other very puzzled here on the table. We never changed our guidance. So can you clarify that? Sorry, I had that you had original guidance that you gave in the first quarter for the second quarter of 43 to 45 million for the second quarter. And then during the quarter in a PowerPoint presentation that you had on your website, the guidance was changed to 38 to 40 million unless I'm mistaken, and maybe I was looking at an older presentation.

Speaker Change: Yeah, Hi, Ed it's Alan on your first comment.

Speaker Change: We didn't change our Q1 revenue guidance for near links can you clarify that we have no. We're all looking each other very puzzled here around the table.

Speaker Change: We never changed our guidance so can you clarify that.

Speaker Change: Oh I'm sorry.

Ed White: I had that you had.

Speaker Change: Original guidance.

Speaker Change: That you gave in the first quarter for the second quarter of 43 to.

Speaker Change: $45 million for the second quarter, and then during the quarter and a Powerpoint presentation that you had on your website the guidance would change the $38 million to $40 million.

Speaker Change: Unless I'm mistaken and maybe I was looking at an older presentation.

Alan Auerbach: Yeah, we never changed this. Okay, thanks Alan. That's my mistake. We checked the website; I don't have any. I apologize that I'm not; I was not aware there was a presentation put on a website doing that. If it was, it was an error. We never changed the Q2 revenue number. There was no revenue guidance change. So I apologize if, for some reason, that happened. It may have been some, you know, older presentation or something that somehow got linked somewhere or something, but we never changed our Q2 revenue, U.S. near-links revenue guidance. Any Q2 guidance was never changed from what we put out on our Q1 earnings call.

Speaker Change: Yeah, we never changed it.

Speaker Change: Uh huh.

Speaker Change: Okay. Thanks, Tom that that's my mistake I apologize.

Speaker Change: We check the website I don't have any I apologize that I'm not I was not aware there was a presentation, Florida website doing that if it was it was an error we never changed the Q2 revenue number there was no revenue guidance change so I apologize if for some reason that happened.

Alan Auerbach: We will check on that error. It may have been some..you know, older presentation or something that somehow got linked somewhere or something, but we never changed our Q2 revenue, U.S. Near Links Revenue Guidance, or any Q2 guidance was never changed from what we put out on our Q2.

Speaker Change: It was not and we will we will get back on that.

Speaker Change: It was never it it may have been some.

Speaker Change: Older presentation, or something that somehow got leaked somewhere or something but we never changed our Q2 revenue U S near links revenue guidance or any any Q2 guidance was never changed for what we put out on our Q1 earnings call.

Speaker Change: Okay. Thanks for that.

Speaker Change: Yeah, I did I apologize.

Alan Auerbach: Alan Auerbach, Maximo Nougues, Edward White, Marc Reo, Harshita Polishetty, Puma Biotechnology Inc. It's my apologies for the confusion. I wish I was aware of that earlier. I didn't know that. So again, we'll check on that. We'll get back to you. Thank you for bringing it to our attention.

Speaker Change: My apologies for the confusion I wish I was aware of that earlier I didn't know that so again, we'll check on that we'll get back to you. Thank you for bringing it to our attention.

Alan Auerbach: On the second one, which is the bolus in the royalties. For all of our the various regions, we get our royalties basically as they're sold, if you will, so it's kind of direct. The one outlier is in China, which is that we get our sales kind of when they're sold into the channel. And so that's what gets this lumpiness. So, kind of if you look at our historical royalties, you'll always see, like, once a year or so, this big bolus, and that's usually just one big shipment into China. So it's not based on end user demand.

Speaker Change: On the second one which is the bolus in.

Speaker Change: The royalties.

Speaker Change: For all of our the various regions, we get our royalties at basically as they are sold if you will so it's kind of direct the one outlier is in China.

Alan Auerbach: Which is that we get our sales kind of when they're sold into the channel. And so that's what causes this lumpiness.

Speaker Change: Which is that we get our sales kind of when they're sold into the channel.

Alan Auerbach: So if you look at our historical royalties, you'll always see, like, once a year or so, this big bolus, and that's usually just one big shipment into China. So it's not based on end-user demand. It's more based on sales into the channel.

Speaker Change: And so that's what gets this lumpiness so kind of if you look at our historical royalties, you'll always see like once a year. So this big bolus and that's usually just one big shipment into China. So it's not based on end user demand.

Alan Auerbach: It's more based on sales into the channel. So we get this lumpiness. It happens once a year. I realize it creates some confusion. But that's the nature of the way the agreement is set up. Okay, thanks so. Sure. Thank you.

Speaker Change: It's more based on sales into the channel.

Speaker Change: So we get this lumpiness it happens once a year I realize it creates some confusion, but that's the nature of the way the agreement is set up.

Speaker Change: Okay.

al: Okay. Thanks al.

Speaker Change: Sure.

Speaker Change: Thank you and that concludes our question and answer session I would like to turn the conference back to Mary Anne for closing remarks.

Operator: And that concludes our question-and-answer session.

Mariann Ohanesian: I would like to turn the conference back to Mary Ann for closing remarks. Thank you for joining us today. As a reminder, this call may be accessed via replay of the webcast at PumaBioTechnology.com beginning later today. Have a good evening.

Speaker Change: Yes.

Mary Anne: Thank you for joining us today as a reminder, this call may be accessed via replay of the webcast and Puma biotechnology dotcom. Beginning later today have a good evening.

Speaker Change: Okay.

Operator: Ladies and gentlemen, thank you for participating in today's conference call.

Speaker Change: Okay.

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.

Operator: This concludes our program. Everyone have a great day. You may now...