Q1 2024 Puma Biotechnology Inc Earnings Call

Hum.

[music].

Uh huh.

[music].

Good afternoon, My name is Camille and I will be your conference call operator today.

At this time all participants are in a listen only mode.

After the Speakers' formal remarks, there'll be a question and answer session.

If you'd 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 question. Please press star two.

If you should require operator assistance during the conference. Please press Star zero.

As a reminder, this conference call is being recorded.

Operator: and Mariann Ohanesian, Divya Rao, Harshita Polishetti, Alexandria Hammond, Puma Biotechnology Inc and ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ?? ??

I would now like to turn the conference call over to Marianne O Hannesson senior director of IR for Puma Biotechnology.

Mariann Ohanesian: Good afternoon. My name is Camilla, and I will be your conference call operator today. 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. If you would like to ask a question during that time, simply press the star key and then the number 1 on your telephone keypad. If you would like to withdraw your question, please press star 2. If you should require operator assistance during the conference, please press star zero. As a reminder, this conference call is being recorded. I would now like to turn the conference call over to Mariann Ohanesian, Senior Director of IR for Puma Biotechnology. You may begin your conference.

Speaker Change: May begin your conference.

Mariann Ohanesian: Thank you Camilla good afternoon, and welcome to this conference call to discuss our financial results for the first quarter of 2024.

Mariann Ohanesian: Good afternoon, and welcome to Puma's conference call to discuss our financial results for the first quarter of 2024. 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. After the market closed today, Puma issued a news release detailing first quarter 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.

Mariann Ohanesian: Joining me on the call today are Alan Auerbach, Chief Executive Officer, President and Chairman of the board of Puma Biotechnology, Massimo <unk>, Chief Financial Officer, and Jeff Ludwig Chief Commercial Officer.

Mariann Ohanesian: After market close today Puma issued a news release detailing first quarter 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.

Mariann Ohanesian: I'm, a biotechnology dot com.

Mariann Ohanesian: 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 risks and uncertainties, and actual events and results may differ from those expressed in these forward-looking statements. For a full discussion of these risks and uncertainties, see 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.

Mariann Ohanesian: Today's conference call will include statements about future expectations plans and prospects that constitute forward looking statements for purposes of federal Securities laws.

Mariann Ohanesian: Such statements are subject to risks and uncertainties and actual events and results may differ from those expressed in these forward looking statements.

Mariann Ohanesian: For a full discussion of these risks and 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.

Mariann Ohanesian: You are cautioned not to place undue reliance on these forward looking statements, which speak only as of the date of this conference call may check in 2024.

Mariann Ohanesian: You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this live conference call, May 2, 2024. 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. 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. Please refer to our first quarter 2024 news release for a reconciliation of our GAAP to non-GAAP results. I will now turn the call over to Alan.

Mariann Ohanesian: Undertakes no obligation to revise or update any forward looking statements to reflect these answers circumstances. After the date of this conference call, except as required by law.

Alan: 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.

Alan: Please refer to our first quarter 2024 news release for a reconciliation of our GAAP to non-GAAP results.

Mariann Ohanesian: I will now turn the call over to Alan.

Alan: Thank you Marianne.

Alan H. Auerbach: Thank you, Mariann, and thank you all for joining our call. Today, Puma reported total revenue for the first quarter of 2024 of $43.8 million.

Alan: Thank you all for joining our call today.

Alan: Today Puma reported total revenue for the first quarter of 2024 or.

Alan: $43 8 million.

Alan H. Auerbach: Total revenue includes product revenue net, which consists entirely of Neuralink sales, as well as royalties from our sub-licenses. Product revenue net was $40.3 million in the first quarter of 2020, which was a decrease from the 53.2 million... Q4 2023 and below the 46.8% reported in Q1. Product revenue for the first quarter of 2024 was impacted by approximately $2 million of inventory drawdown at our specialty pharmacies and specialty distributors. Royalty revenue was $3.5 million in the first quarter of 2024, compared to $19 million in Q4 of 2023 and $6 million in Q1 of 2020.

Alan: Total revenue includes product revenues net which consists entirely new airlink sales as well as royalties from our sub licensees.

Alan H. Auerbach: Product revenue was $40 3 million.

Alan H. Auerbach: The first quarter of 2024, which was a decrease of $53 2 million reported in Q4, and 2023 and below $46 8 million reported in Q1 2023.

Alan H. Auerbach: Product revenue for the first quarter of 2024 was impacted by approximately 2 million of inventory draw down in our specialty pharmacies and specialty distributors royalty revenue was $3 5 million in the first quarter of 2024 compared to $19 million in Q4 of 2023 and 6 million in Q1 of 2020.

Alan H. Auerbach: Sorry.

Alan H. Auerbach: We reported 2410 bottles of <unk> sold in the first quarter of 2024.

Alan H. Auerbach: We reported 2,410 bottles of Neuralinks sold in the first quarter of 2024, a decrease of 471 bottles from the 2,881 bottles sold. 2004, 2005, 2006, 2007, 2008, 2009, 2011, 2012, 2013, 2014, 2015, 2016, 2017, 2018, Q1 2024, we estimate that inventory decreased by about $120. In Q1 2024, new prescriptions were up approximately 27% compared to Q4 2026, and total prescriptions were down approximately 3% compared to Q4 2008. Jeff will provide further details in his comments. Nearly all sales were negatively impacted by the decline in enrollments that we mentioned previously in our third and fourth quarter earnings calls. Jeff will discuss this further in his comments.

Alan H. Auerbach: Decrease of 471 bottles from the 2881 bottle sold in Q4 2023.

Alan H. Auerbach: Q1, 2024, and we estimate that inventory decreased by about 120 Bucks in.

Alan H. Auerbach: In Q1, 2024, new prescriptions are up approximately 27% compared to Q4 2023.

Jeff: And total prescriptions were down approximately 3% compared to Q4 2023.

Alan H. Auerbach: Jeff will provide further details in his comments and slides.

Alan H. Auerbach: Sales were negatively impacted by the decline in enrollments that we mentioned previously in our third and fourth quarter earnings calls Jeff will discuss this further in his comments we have continued to reduce our internal expenses to account for these factors as we recognize our fiscal responsibility to shareholders to continue to be net income positive for two.

Alan H. Auerbach: We have continued to reduce our internal expenses to account for these factors, as we recognize our fiscal responsibility to shareholders to continue to be net income positive for 2020. I will now provide a clinical review of the quarter, then Jeff Ludwig will address color on near-linked commercial activities, and Maximo Nougues will follow with highlights of the key components of our financial statement for the first quarter of 2020. In February, we are pleased to announce that we initiated the Alisertib-in-Cancer or ALISCA Lung 1 trial, a Phase II clinical trial of Alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer.

Alan H. Auerbach: 24.

Alan H. Auerbach: I will now provide a clinical overview of the quarter, then Jeff Ludwig well addressed colour on <unk> commercial activities.

Alan H. Auerbach: Moving to gas will follow with highlights of the key components of our financial statements for the first quarter 2024.

Alan H. Auerbach: In February we are pleased to announce that we initiated the Alistair and cancer or let's go lock one trial.

Alan H. Auerbach: This trial was previously referred to as study Puma ALI 4201. The trial will enroll up to 60 patients with extensive stage small cell lung cancer who have progressed after first-line platinum-based chemotherapy and immunotherapy. Patients must provide tissue-based biopsies so that biomarkers can be added. Allicerative will be dosed at 50mg BID on days 1 through 7 of every 21 day cycle.

Alan H. Auerbach: Page two trial clinical trial of Alistair mono therapy.

Alan H. Auerbach: Treatment of patients with extensive stage small cell lung cancer.

Alan H. Auerbach: Trial was previously referred to as study Puma ally 42 old one.

Alan H. Auerbach: The trial will enroll up to 60 patients with extensive stage small cell lung cancer, who have progressed after first line platinum based chemotherapy and immunotherapy patients.

Alan H. Auerbach: Patients must provide tissue based biopsies, so that biomarkers can be analyzed.

Alan H. Auerbach: <unk> will be dosed at 50 milligrams B I D. On days one through seven of every 21 day cycle.

Alan H. Auerbach: Puma plans to perform an interim analysis for the evaluation of the Biomarkers as well as in evaluation of efficacy.

Alan H. Auerbach: Puma plans to perform an interim analysis for the evaluation of the biomarkers as well as an evaluation of efficacy. As we discussed on our last earnings call, the goal of this Phase 2 study will be to confirm the ethical... Allocertive monotherapy in patients with small cell lung cancer who have biomarkers where the aurora kinase pathway plays a role. The goal would be to correlate the efficacy in these biomarker subgroups in the ELISCO Lung 1 study to the efficacy that was previously seen in the biomarker subgroup from the randomized trial of papitaxel plus L-assertive vs. Paclitaxel plus placebo that was published in the Journal of Thoracic Oncology in 2020, if the efficacy and biomarker data are comparable between the

Alan H. Auerbach: As we discussed on our last earnings call. The goal of this phase II study will be to confirm the efficacy of all sorts of monotherapy in patients with small cell lung cancer with biomarkers for the Aurora kinase pathway plays a role.

Alan H. Auerbach: The goal would be to correlate the efficacy in these biomarker subgroups and Eliska lung one study.

Alan H. Auerbach: Yes cause C that was previously seen in the biomarker subgroups from the randomized trial of Paclitaxel plus Alistair.

Alan H. Auerbach: Paclitaxel plus placebo that was published in the journal of thoracic oncology in 2020.

Alan H. Auerbach: If the efficacy and biomarker data are comparable from the two studies. The company believes it would represent a potential accelerated approval strategy and engage F. D. A to discuss this further.

Alan H. Auerbach: The company believes it would represent a potential accelerated approval strategy and will engage FDA to discuss... We currently have approximately 16 sites open for enrollment, and we expect to have a total of approximately 25 sites contributing to enrollment in the study. We anticipate that we will be able to share interim data from this trial with investors in the second half of 2020. We also anticipate the initiation of ELISCA Breast 1, a phase 2 trial of alisertin in combination with endocontrol in patients with chemotherapy-naive, HER2-negative, hormone-receptor-positive metastatic breast cancer, in Q4 2020.

Alan H. Auerbach: We currently have approximately 16 sites open for enrollment and we expect to have a total of approximately 25 sites contributing to enrolment in the study.

Alan H. Auerbach: We anticipate that we will be able to share interim data from this trial with investors in the second half of 2024.

Alan H. Auerbach: We also anticipate the initiation of a less compressed one a phase two trial of al asserted in combination with other treatments and patients with chemotherapy naive her two negative hormone receptor positive metastatic breast cancer in Q4 2024.

Alan H. Auerbach: We Additionally, anticipated two clinical data presentations at an illustrated at the 2024 <unk> annual meeting in early June.

Alan H. Auerbach: We additionally anticipate two clinical data presentations on L-Assertive 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 II trial of our Assertive Mental Therapy versus Aleph Sertib plus endocrine therapy in patients with HER2-negative, hormone receptor-positive metastatic breast cancer, was published in JAMA Oncology As part of this trial, an analysis of biomarkers was performed to determine if the efficacy of Alisertib in patients with HER2 negative, hormone receptor positive metastatic breast cancer correlates with any biomarkers.

Alan H. Auerbach: Investors will remember that the phase two trial referred to as T. V. C. R. C 41, which was a phase two trial of al assertive bundle therapy versus Alice startup plus endocrine therapy and patients with her two negative hormone receptor positive metastatic breast cancer.

Alan H. Auerbach: Was published in Jama oncology in 2023.

Alan H. Auerbach: As part of this trial and analysis of Biomarkers was performed in order to determine the efficacy of al asserted in patients with hurts your negative hormone receptor positive metastatic breast cancer correlates with any biomarkers.

Alan H. Auerbach: The biomarker data from this trial will be presented in a poster presentation at the 2024 ASCO Annual Meeting. In addition, there is an ongoing investigator-sponsored trial of Alicertib given in combination with Osimberg in patients with metastatic EGFR mutant non-smell so long, more specifically, patients with metastatic EGFR. [inaudible] are treated with And then at the time of progression, Al-Assertive is added to, in order to see if I can overcome Osamartin and Brzezinski.

Alan H. Auerbach: The biomarker data from this trial will be presented in a poster presentation at the 2024 at <unk> annual meeting.

Alan H. Auerbach: In addition, there is an ongoing investigator sponsored trial of Alistair Kevin in combination with <unk>.

Alan H. Auerbach: In patients with metastatic Egfr mutant non small cell lung cancer more.

Alan H. Auerbach: More specifically patients with metastatic Egfr mutant non small cell lung cancer are treated with western markets and then at the time of progression Alistair is added to Austin market in order to see if Alistair.

Alan H. Auerbach: Overcome or Sam Martin of resistance.

Alan H. Auerbach: Interim data on this trial were previously presented at ASCO prior to Puma licensing the trial. Updated data on this trial will also be presented as a poster presentation at the 2024 ASCO annual meeting. As we mentioned on our last earnings call, a recent biomarker analysis from this trial has demonstrated a subgroup of patients where the aurora kinase pathway plays a role where allosertive appears to have much greater efficacy. When added to osimertinib at the time of progression on a, this biomarker occurs in about half of the patients in the trial, which is consistent with the published literature on this biomarker in this patient population.

Alan H. Auerbach: Interim data on this trial was previously presented at Astro prior to Puma licensing the drug updated data on this trial will also be presented as a poster presentation at the 2020 for <unk> annual meeting.

Alan H. Auerbach: As we mentioned on our last earnings call. A recent biomarker analysis from this trial has demonstrated a subgroup of patients.

Alan H. Auerbach: With a biomarker with IRAK kinase pathway plays a role.

Alan H. Auerbach: Alistair appears to have much greater efficacy.

Alan H. Auerbach: When added to our San Martin at the time of progression.

Alan H. Auerbach: This biomarker occurs in about half of the patients in the trial, which is consistent with the published literature on this biomarker in this patient population.

Alan H. Auerbach: Based on this biomarker data, the trial has been amended to limit enrollment in the trial to only continue enrolling patients who have this biomarker. We believe that this might represent another potential indication for Alex, and we look forward to discussing this data with investors once it has been presented publicly. Of note, the biomarker data is not contained in the ASCO abstract but will be presented in the ASCO poster, as mentioned on prior earnings calls and in response to investor questions.

Alan H. Auerbach: Based on this biomarker data the trial has been amended to limit enrolment in the trial to only continue enrolling patients who have this biomarker.

Alan H. Auerbach: We believe that this might represent another potential indication for <unk> and we look forward to discussing this data with investors. Once it has been presented publicly.

Alan H. Auerbach: Of note. The biomarker data is not contained in the <unk> abstract but will be presented in the ask a poster.

Alan H. Auerbach: As 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 its existing R&D regulatory and commercial infrastructure. The company will keep investors updated on this as it progresses.

Alan H. Auerbach: Puma continues to evaluate several drugs to potentially analyze, that would allow the company to diversify itself and leverage Puma's existing R&D, regulatory, and commercial... 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... Thanks Alan. I appreciate it.

Alan H. Auerbach: I'll now turn the call over to Jeff Ludwig <unk>, Chief Commercial Officer for review of our commercial performance during the quarter.

Jeffrey Jerome Ludwig: Thanks to everyone for joining our first quarter earnings call. Before I move into the commercial review, just a reminder that I will be making forward-looking statements. The commercial team remains largely focused on the extended adjuvant indication where the majority of Neuralink sales and opportunity exist. A significant portion of early-stage HER2-positive breast cancer patients are treated in a community setting, so the sales and marketing teams are focused on increasing reach and frequency to targeted customers with both personal and non-personal promotion.

Jeffrey Jerome Ludwig: Thanks, Alan I appreciate it thanks to everyone for joining our first quarter earnings call.

Jeffrey Jerome Ludwig: Before I move into the commercial review.

Jeffrey Jerome Ludwig: A reminder, that I will be making forward looking statements.

Jeffrey Jerome Ludwig: The commercial team remains largely focused on the extended adjuvant indication, where the majority of <unk> sales and opportunity exists.

Jeffrey Jerome Ludwig: Significant portion of early stage her two positive breast cancer patients are treated in the community setting. So the sales and marketing teams are focused on increasing our reach and frequency to targeted customers with both personal and non personal promotion.

Jeffrey Jerome Ludwig: H C. P calls in the first quarter increased about 5% quarter over quarter with greater than 80% being live interactions.

Jeffrey Jerome Ludwig: HCP calls in the first quarter increased about 5% quarter over quarter, with greater than 80% being live interactions. We continue to evaluate new data and partners to try and make our targeting and overall timing of calls more efficient and effective. We are looking for opportunities to increase awareness and education around the unmet need that exists in the early stage breast cancer setting and are trying to align with key customers to better identify patients at higher risk of reoccurrence.

Jeffrey Jerome Ludwig: We continue to evaluate new data and partners to try and make our targeting and overall timing of calls more efficient and effective.

Jeffrey Jerome Ludwig: We're looking for opportunities to increase the awareness and education around the unmet need that exists in the early stage breast cancer cancer, setting and are trying to align with key customers to better identify patients at high risk of recurrence.

Jeffrey Jerome Ludwig: The commercial team is committed to becoming more efficient and effective with their resources and balancing the needs of Neuralinks with the broader goals of the organization. Let me now transition to some of the commercial slides, where I will provide some additional specifics around performance. Once I am finished, I will turn the call over to Maximo for a more detailed review of our financial results. Slide three provides an overview of our distribution model. Now, this model has not changed. It remains separated into two distinct channels, the specialty pharmacy channel and the specialty distributor channel.

Jeffrey Jerome Ludwig: The commercial team is committed to becoming more efficient and effective with our resources and balancing the needs of neuro links with the broader goals of the organization.

Jeffrey Jerome Ludwig: We do typically see quarterly fluctuations, but the majority of our business flows through the specialty pharmacy channel. In Q1, about 74% of our business went through the specialty pharmacy channel, and the remaining 26% went through the specialty distributor channel. This is essentially unchanged from what we reported during our Q4 earnings call. Turning to slide four, NeurLink's net revenue in Q1 of 2024 was $40.3 million, which is a $12.9 million decrease from the $53.2 million we reported in Q4 of 2023 and a $6.5 million decrease from the $46.8 million we reported in Q1 of 2023.

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

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

Jeffrey Jerome Ludwig: Slide three provides an overview of our distribution model and this model has not changed it remains separated into two distinct channels, the specialty pharmacy channel and the specialty distributor channel.

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

Jeffrey Jerome Ludwig: In Q1 about 74% of our business went through the specialty pharmacy channel and the remaining 26% went through the specialty distributor channel. This.

Jeffrey Jerome Ludwig: This is essentially unchanged from what we reported during our Q4 earnings call.

Jeffrey Jerome Ludwig: Turning to slide four.

Jeffrey Jerome Ludwig: Inventory changes will impact these comparisons, so let me provide some additional information. In Q1 of 2024, we estimate that inventory decreased by about $2 million. As a comparison, we estimate that inventory increased by about $2.1 million in Q4 of 2023 and decreased by about $3.8 million in Q1 of 2023. Slide 5 shows Q1 of 2024 X-Factory bottle sales and also provides both a year-over-year and a quarter-over-quarter comparison. In Q1 of 2024, Neuralink's X-Factory bottle sales were 2,410, which represents a 16% quarter-over-quarter decline and a 15% year-over-year decline. Let me again provide more specifics around inventory changes.

Jeffrey Jerome Ludwig: <unk> net revenue in Q1 of 2024 was $40 3 million, which is a $12 9 million decrease from the $53 2 million. We reported in Q4, 2023, and a $6 $5 million decrease from the $46 8 million, we reported in Q1 of 'twenty three.

Jeffrey Jerome Ludwig: In the inventory changes will impact these comparisons so let me provide some additional information.

Jeffrey Jerome Ludwig: In Q1 of 'twenty 'twenty, four we estimate that inventory decreased by about $2 million.

Jeffrey Jerome Ludwig: As a comparison, we estimate the inventory increased by about $2 1 million in Q4 of 2023 and decreased by about $3 8 million in Q1 of 'twenty three.

Jeffrey Jerome Ludwig: Slide five shows Q1 of 'twenty 'twenty four ex factory bottle sales and also provides both a year over year and quarter over quarter comparison.

Jeffrey Jerome Ludwig: In Q1 of 'twenty 'twenty, four New Orleans ex factory bottle sales for 2000, and 410, which represents a 16% quarter over quarter decline and a 15% year over year decline.

Jeffrey Jerome Ludwig: Let me again provide more specifics around inventory changes we.

Jeffrey Jerome Ludwig: We estimate that inventory decreased by about 120 bottles in the first quarter of 2024. As a comparison, we estimate that inventory increased by about 127 bottles in Q4 of 23, and decreased by about 236 bottles in Q1 of 2023. Now, let me share some additional metrics and insights into our first quarter performance. In Q1, we saw new patient starts, or NRX, increase about 27% quarter over quarter and decline about 15% year over year.

Jeffrey Jerome Ludwig: We estimate that inventory decreased by about 120 bottles in their first quarter of 2024.

Jeffrey Jerome Ludwig: As a comparison, we estimate that inventory increased by about 127 bottles in Q4 of 23 and.

Jeffrey Jerome Ludwig: And decreased by about 236 bottles in Q1 of 2023.

Jeffrey Jerome Ludwig: In terms of total prescriptions, or TRX, we saw a 3% decline quarter over quarter and a 16% decline year over year. Overall, demand decreased in the first quarter by about 8% quarter over quarter and about 18% year over year.

Jeffrey Jerome Ludwig: Now, let me share some additional metrics and insights into our first quarter performance.

Jeffrey Jerome Ludwig: In Q1, we saw net we saw excuse me new patient starts or interacts increase about 27% quarter over quarter and declined about 15% year over year.

Jeffrey Jerome Ludwig: In terms of total prescriptions or T. Rx, we saw a 3% decline quarter over quarter, and a 16% decline year over year.

Jeffrey Jerome Ludwig: Overall demand decreased in the first quarter by about 8% quarter over quarter and about 18% year over year.

Jeffrey Jerome Ludwig: As Alan mentioned, Q1 performance was negatively impacted by the decline in enrollments we discussed in our Q4 and Q3 earnings calls last year. However, enrollments continue to be an important leading indicator as enrollments turn into new patient starts, and new patient starts turn into refills, which drive demand in subsequent quarters. As previously discussed, we saw an increased softness in enrollments in the second half of 2023, driven largely by a decline that occurred in the first part of Q3.

Jeffrey Jerome Ludwig: As Alan mentioned Q1 performance was negatively impacted by the decline in enrollments, we discussed in our Q4 and Q3 earnings call last year.

Jeffrey Jerome Ludwig: Enrollments continue to be an important leading indicator as enrollments turned into new patient starts and new patient starts it turned into refills, which drive demand in subsequent quarters.

Jeffrey Jerome Ludwig: As previously discussed we saw increased softness in enrollments in the second half of 2023, driven largely by a decline that occurred in the first part of Q3.

Jeffrey Jerome Ludwig: Since that time, we have seen an improvement in enrollments, but not enough yet to offset the impact of bottles. We are currently seeing.

Jeffrey Jerome Ludwig: Since that time, we have seen an improvement in enrollments, but not yet enough yet to offset the impact of the bottles we are currently seeing. In Q1, enrollments did increase about 5% quarter over quarter, but we're down about 12% year over year. The team is solely focused on driving both quarter-over-quarter and year-over-year growth.

Jeffrey Jerome Ludwig: In Q1 enrollments did increase about 5% quarter over quarter, but were down about 12% year over year. The team is solely focused on driving both quarter over quarter and year over year growth.

Jeffrey Jerome Ludwig: Turning to slide six slide six highlights the adoption of dose escalation since launch we continue to believe that dose escalation is a very important metric for an <unk> patient.

Jeffrey Jerome Ludwig: Turning to slide six, slide six highlights the adoption of dose escalation since launch. We continue to believe that dose escalation is a very important metric for NeurLynx because patients that start at a reduced dose will experience significantly lower grade 3 diarrhea and are likely to have a lower rate of discontinuation.

Jeffrey Jerome Ludwig: Patients that start at a reduced dose will experienced significantly lower grade three diarrhea and are likely to have a lower rate of discontinuation.

Jeffrey Jerome Ludwig: In Q1, approximately 67% of patients who received commercial drug started NeurLynx at a reduced dose. This is lower than the 76% that we reported in Q4 of 2023, but is higher than what we reported in Q1 of 2023 one year ago. The feedback from customers continues to be positive, and the benefits of dose escalation remain a key commercial message. Moving to slide seven.

Jeffrey Jerome Ludwig: In Q1, approximately 67% of patients who received commercial drug started an airlink at a reduced dose.

Jeffrey Jerome Ludwig: This is lower than the 76% that we reported in Q4 of 2023.

Jeffrey Jerome Ludwig: It is higher than what we reported in Q1 of 2023, one year ago.

Jeffrey Jerome Ludwig: The feedback from customers continues to be positive and the benefits of dose escalation remained a key commercial message.

Jeffrey Jerome Ludwig: Slide seven highlights the strategic collaborations we have formed across the globe. In Q1, Neuralinks received regulatory approval in Syria in the extended adjuvant setting and was officially launched in Morocco, also in the extended adjuvant setting. We truly appreciate all the efforts put forth by our partners, and we continue to look for opportunities to make Neuralinks available to more patients around the world. I'd like to wrap up by thanking my Puma colleagues for their support and commitment.

Jeffrey Jerome Ludwig: Moving to slide seven slide seven highlights the strategic collaborations we have formed across the globe.

Jeffrey Jerome Ludwig: In Q1, <unk> received regulatory approval in Syria in the extended adjuvant setting and it was officially launched in Morocco also in the extended adjuvant setting.

Jeffrey Jerome Ludwig: We truly appreciate all the efforts put forth by our partners and we continue to look for opportunities to make <unk> available to more patients around the world.

Jeffrey Jerome Ludwig: I'd like to wrap up my thinking my <unk> colleagues for their support and commitment. The team is passionate about making a difference in the lives of patients and their families battling cancer.

Jeffrey Jerome Ludwig: The team is 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 our resources and also committed to balancing the short-term and long-term priorities of Puma and its shareholders. I will now turn the call over to Maximo for a review of our financial results. Maximo?

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.

Jeffrey Jerome Ludwig: I will now turn the call over to Maximo for a review of our financial results excellent.

Maximo: Thanks, Jeff.

Maximo: I will begin with a brief summary of our financial results for the first quarter of 'twenty 'twenty four.

Maximo F. Nougues: I will begin with a brief summary of our financial results for the first quarter of 2024. Please note that I will make comparisons to Q4 2023, which we believe is a better indication of our progress as a commercial company than year-over-year comparisons. For more information, I recommend that you refer to our Q1 Thank You, which will be filed today and includes our consolidated financial statements. For the first quarter of 2024, we reported a net loss based on GAP of $4.8 million. Thanks, that's for sure.

Maximo F. Nougues: Please note that I will make comparisons to Q4 2023, which we believe is a better indication of our progress as a commercial company than year over year comparisons.

Maximo F. Nougues: For more information.

Maximo F. Nougues: I meant that you refer to our Q1 10-Q, which we will.

Maximo F. Nougues: Five today.

Maximo F. Nougues: Our consolidated financial statements.

Maximo F. Nougues: Well the first quarter of 2024, we reported a net loss based on GAAP of $4 8 million.

Maximo F. Nougues: Per share this.

Maximo F. Nougues: This compares to net income in Q4 2023 of $12.3 million, or $0.26 per share, on a non-GAD basis, which is suggested to remove the impact of stock-based compensation expenses. We reported a net loss of $2.4 million, or $0.05 per share, for the first quarter of 2024. Gross revenue from Netlink sales was $52.6 million in Q1 2024 and $64.9 million in Q4 2020. As Alan mentioned, net product revenue from Netlink sales was $40.3 million, a decline from $53.2 million reported in Q4 2020. Acute magnetic cells were impacted by lower enrollments in Q3 and Q4, as well as higher gross-to-net adjustment in Q3 and Q4.

Maximo F. Nougues: This compares to net income in Q4, 2023 of $12 3 million or 26%.

Maximo F. Nougues: A non-GAAP basis, which is adjusted to remove the impact of stock based compensation expense.

Maximo F. Nougues: We reported a net loss of $2 4 million or five cents per share for the first quarter of two four.

Maximo F. Nougues: Gross revenue from <unk> sales was <unk>.

Maximo F. Nougues: $2 6 million in Q1, 'twenty 'twenty four.

Maximo F. Nougues: $64 9 million in Q4.

Maximo F. Nougues: So I'm imagining net product revenue from <unk> was $40 3 million.

Maximo F. Nougues: We climbed from $53 2 million recorded in Q4 2023.

Maximo F. Nougues: Q1, net sales were impacted by lower enrollment Miss in Q3, and Q4 as well as higher gross to net adjustment in Q1.

Maximo F. Nougues: Yeah.

Maximo F. Nougues: Inventory drawdown by our distributors was approximately $2 million in Q1 versus approximately $2.1 million of buildup in Q4 2021. Royalty revenue totaled $3.5 million in the first quarter of 2024 compared to $19 million in Q4 2024. As expected, the lower royalties versus Q4 reflect the timing of shipments to our party in China, as we noted last quarter. Our gross net adjustment in Q1 2024 was about 23.4%, compared to the 18.1% gross net adjustment reported in Q4 2020. Higher government chargebacks and higher co-pay were the main drivers of the increase versus Q4 2023.

Maximo F. Nougues: Inventory draw Bell by our distributors was approximately $2 million in Q1.

Maximo F. Nougues: Specials, approximately $2 1 million buildup in Q4 2023.

Maximo F. Nougues: Loyalty revenue totaled $3 5 million.

Maximo F. Nougues: First quarter of 'twenty, 'twenty, four compared to $19 million in Q4 2023.

Maximo F. Nougues: As expected the lower royalties versus Q4 reflect the timing of shipments to our partner in China as we noted last quarter.

Maximo F. Nougues: Our gross to net adjustment in Q1, 'twenty 'twenty four it was about 23, 4%.

Maximo F. Nougues: Compared to the 18, 1% gross to net adjustment reported in Q4 2023.

Maximo F. Nougues: Higher government charters box on higher co pays were the main drivers of the increase versus Q4 2023.

Maximo F. Nougues: Cost of sales for Q1, 'twenty 'twenty, four wall standpoint, 7 million, including $2 4 million for the amortization of intangible assets related to our <unk> license.

Maximo F. Nougues: Cost of sales for Q1 2024 was $10.7 million, including $2.4 million for the amortization of intangible assets related to our Neratinib license. Capital sales for Q4 2023 were $24.3 million. Going forward, we will continue to recognize amortization of milestones to the licensensure of about $2.4 million per quarter as cost of sales. In fiscal year 2024, Puma anticipates that net Netherlinks 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 21.5% and 22.5%, higher than 2023 due to the impact of the Inflation Reduction Act and higher expected Medicaid revenues.

Maximo F. Nougues: Cost of sales for Q4, 2023 was $24 3 million.

Maximo F. Nougues: Going forward, we will continue to recognize amortization of milestones to the list.

Maximo F. Nougues: Sure.

Maximo F. Nougues: About $2 4 million per quarter as cost of sales.

Maximo F. Nougues: For fiscal year 'twenty to 'twenty four.

Maximo F. Nougues: D C page the net Nellix puzzle revenue will be in the range of $183 million to $190 million.

Maximo F. Nougues: We also anticipate that our gross to net adjustment for the full year 'twenty 'twenty four will be between 21, 5% I'm 22, 5%.

Maximo F. Nougues: Higher than 2023 due to the impact of the inflation reduction on higher expected Medicaid.

Maximo F. Nougues: In addition, well there.

Maximo F. 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. We expect license revenue in the range of $1 to $2 million. We also expect that net income for the full year will be in the range of $12 to $15 million. Additionally, we anticipate that for Q2 2024, Nanolix Net Product Revenue will be in the range of $43 to $45 million.

Maximo F. Nougues: Fiscal year 'twenty to 'twenty, four we anticipate receiving royalties from our partners around the world in the range of 30 to 33 million.

Maximo F. Nougues: We expect licenses license revenue in 2024 in the range of $1 million to $2 million.

Maximo F. Nougues: We also expect that net income for the full year will be in the range of 12 to 15 million.

Maximo F. Nougues: We anticipate that for Q2, 'twenty 'twenty four nellix net product revenue will be in the range of 43 to 45 million.

Maximo F. Nougues: Also, we expect Q2 royalty revenues will be in the range of $2.5 to $3 million, and we anticipate no licensed revenues. We further estimate the gross net adjustment in Q2 2024 will be approximately 22% to 23%. Puma anticipates a Q2 net loss of between $6 and $9 million. Due to our litigation expenses and a one-time all-assertive expense, we expect higher expenses in Q2 than any other quarters in 2024. Due to these items, we are forecasting a net loss in Q2, but we anticipate that Puma will be netting competitive for the remainder of 2024, as well as for the full year.

Maximo F. Nougues: Also we expect Q2 royalty revenues will be in the range of 2.53 million, we anticipate no license right.

Maximo F. Nougues: We further estimate that gross to net adjustment in Q2, 'twenty 'twenty four will be approximately 22%.

Maximo F. Nougues: <unk> 23 per cent.

Maximo F. Nougues: Well Mark do you see paid a Q2 net loss of between six 9 million.

Maximo F. Nougues: Due to our litigation expenses and a one time all instructive expense, we expect higher expenses in Q2.

Maximo F. Nougues: The other quarters in 2024.

Maximo F. Nougues: Due to these items, we are forecasting a net loss in Q2, but we anticipate that Puma will be net income positive for the reminder of 2024 as well as for the full year.

Maximo F. Nougues: SG&A expenses were 21.8 million in the first quarter of 'twenty 'twenty four.

Maximo F. Nougues: SG&A expenses were $21.8 million in the first quarter of 2024 compared to $20.2 million for the fourth quarter of 2022, as SG&A expenses included non-cash charges for stock-based compensation of $1.5 million for Q1 2024, down from $1.8 million in Q4 2024. Research and development expenses were $13.6 million in the first quarter of 2024, compared to $12.9 million in the fourth quarter of 2024. R&D expenses included non-cash charges for stock-based compensation of $0.8 million in the first quarter of 2024, unchanged from the fourth quarter of 2024.

Maximo F. Nougues: Prior to $20 2 million for the fourth quarter of 2023.

Maximo F. Nougues: SG&A expenses included noncash charges for stock based compensation of $1 5 million for Q1 'twenty to 'twenty four.

Maximo F. Nougues: I'll throw 1.8 million in Q4 2023.

Maximo F. Nougues: Research and development expenses were $13 6 million in the first quarter of 2024.

Maximo F. Nougues: Compared to $12 9 million in the fourth quarter of 2023.

Maximo F. Nougues: R&D expenses included noncash charges for stock based compensation of <unk> 8 million in the first quarter of 'twenty 'twenty four.

Maximo F. Nougues: Changed from the fourth quarter of 2022.

Maximo F. Nougues: Yeah.

Maximo F. Nougues: The expense side, two months' dissipates flat with total operating expenses in 2024 compared to 2023.

Maximo F. Nougues: On the expense side, Puma anticipates flat to total operating expenses in 2024 compared to 2023. More specifically, we anticipate SG&A expenses to decrease by 8% to 12% and R&D expenses to increase 17% to 20% year-over-year. Due to our litigation expenses, we expect SG&A expenses in Q2 to be significantly higher than in future quarters.

Maximo F. Nougues: More specifically, we anticipate SG&A expenses to decrease by 8% to 12%.

Maximo F. Nougues: R&D expenses to increase 17%, 20% year over year.

Maximo F. Nougues: Due to our litigation expenses, we expect G&A expenses in Q2 to be significantly higher in future quarters.

Maximo F. Nougues: In the first quarter of 'twenty 'twenty, four Puma reported cash burn of approximately $11 2 million.

Maximo F. Nougues: In the first quarter of 2024, Puma reported cash earnings of approximately $11.2 million. This compares to cash earnings of approximately $10.4 million in Q4 2020. On March 31st, 2024, we had approximately $107 million in cash, cash equivalents, and marketable security, versus about $96 million at year-end 2020. Our accounts receivable balance was $24.6 million. Our accounts receivable terms range between 10 and 68 days, while our day sales outstanding are about 52 days.

Maximo F. Nougues: This compares to cash burn of approximately $10 4 million in Q4 23.

Maximo F. Nougues: At March 31st 2024.

Maximo F. Nougues: Approximately $100 7 million in cash cash equivalents and marketable securities versus about 96 million at year end 2023.

Maximo F. Nougues: Our accounts receivable balance was $24 6 million.

Maximo F. Nougues: Our accounts receivable terms range between 10 and 68 days.

Maximo F. Nougues: Our day sales Outstandings are about 52 days.

Maximo F. Nougues: We estimate that as of March 31st, 2024, our distribution network maintained approximately four weeks of inventory. Overall, we continue to deploy our financial resources to focus on commercializing Neuralinks, the development of Alistair Tiff, and control in our experiments.

Maximo F. Nougues: We estimate that as of March 31, 2020 for our distribution network maintained approximately four weeks of inventory.

Maximo F. Nougues: Overall, we continue to deploy our financial resources to focus on commercialization of Nellix.

Maximo F. Nougues: Element nobodies talk to on controlling our expenses.

Speaker Change: Thanks Maximo.

Maximo F. Nougues: Puma Senior Management, in cooperation with the Board of Directors, continues to remain focused on Neuralink 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 operational cash flow. We believe that the positive net income that was seen in 2023 resulted from these expense reductions.

Maximo F. Nougues: I'm a senior management in cooperation with the board of Directors continues to remain focused on the airlink sales trends in 2024 and beyond and recognizes its fiscal responsibility to shareholders to continue to maintain positive net income.

Maximo F. Nougues: 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.

Maximo F. Nougues: The expense reductions that we have previously performed and continue to perform are also a major contributor to the positive net income that the company is guiding to for the full year 2024. The company remains committed to continuing to achieve this positive net income and will continue to reduce expenses if needed to achieve it. We look forward to updating investors on this in the future. Continuing to remain a significant unmet need for patients battling breast cancer, lung cancer, and other solid tumors.

Maximo F. Nougues: Cost reductions that we have previously performed I continue to perform are also a major contributor to the positive net income that the company is guiding to for the full year 2024.

Maximo F. Nougues: The company remains committed to continuing to achieve positive net income and we will continue to reduce expenses if needed to achieve this we look forward to updating investors on this in the future.

Maximo F. Nougues: It continues to remain a significant unmet need for patients battling breast cancer lung cancer and other solid tumors. We had puma are committed and passionate about finding more effective ways and helping these patients during their journey and we will continue to strive to achieve that goal.

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

Maximo F. Nougues: This concludes today's presentation, we will now turn the floor back to the operator for Q&A operator.

Speaker Change: Thank you 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 that your line is in the question queue.

Operator: Thank you. 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 that your line is in the question queue. If you wish to withdraw your request, please press star 2. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key. One moment, please, while we pull for questions. Your first question comes from the line of Ed White with H.C. Wainwright. Please proceed with your question.

Edward Patrick White: If you wish to withdraw your cut your request please press star two.

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

Operator: Lin please while we poll for questions.

Operator: Your first question comes from the line of Ed White with H C. Wainwright. Please proceed with your question.

Edward Patrick White: Good afternoon, Thanks for taking my questions.

Edward Patrick White: Good afternoon. Thanks for taking my question. So, just a question on sales, a big-picture strategy question, actually. You've said in the past, Alan and Jeff, that sales are in the promotional sense of it, and your SG&A is going to be, expenses are going to be down for the year. I'm just wondering how you're becoming more efficient and able to improve your promotion of the drug while also cutting costs.

Jeffrey Jerome Ludwig: I appreciate it. We do believe this drug is promotionally sensitive, and so we're trying to find efficiencies and effectiveness, as we talked about. One of the ways that we're able to do that is through expanded non-personal promotion, which is a fairly cost-effective way of trying to generate our share of voice. We're also, as I mentioned in my opening, evaluating a large number of partners as well to find, you know, cost-effective competitive ways of expanding our reach frequency, both personal and non-personal, while paying attention to our costs associated with the goals of the organization.

Edward Patrick White: So just a question on sales a big picture strategy questions actually.

Jeffrey Jerome Ludwig: You've said in the past Alan and Jeff that sales are.

Jeffrey Jerome Ludwig: Hum promotional sensitive.

Jeffrey Jerome Ludwig: And your SG&A is going to be your expenses are going to be down for the year I'm, just wondering how you're becoming more efficient and able to target.

Jeffrey Jerome Ludwig: [noise] improve your promotional.

Jeffrey Jerome Ludwig: Promotion of the drug well also cutting costs.

Jeffrey Jerome Ludwig: Yeah, Yeah I appreciate it we do believe this drug as promotional sensitive and so we're trying to find efficiencies and effectiveness as we talked about one of the ways that we're able to do that as we've expanded non personal promotion, which is a fairly.

Jeffrey Jerome Ludwig: Cost effective way of trying to generate our share of voice. We're also as I mentioned in my opening we're evaluating a large number of partners as well.

Jeffrey Jerome Ludwig: To find.

Jeffrey Jerome Ludwig: Cost effective competitive ways of of expanding our reach and frequency, both personal and non personal while paying attention to our costs associated with the goals of the organization.

Speaker Change: Yeah and added as Alan we did a recent analysis looking at both the personal and non personal promotion aspects of the business and kind of you know wishful.

Jeffrey Jerome Ludwig: Yeah, and as Alan mentioned, we did a recent analysis looking at both the personal and non-personal promotion aspects of the business and kind of, you know, which levers contribute more to sales, et cetera. And the non-personal promotion actually was quite effective in terms of its impact on enrollments and things like that. And, as Jeff mentioned, it's much more cost-effective as well. So I think as we increase non-personal promotion, we are increasing share of voice and increasing promotional sensitivity while also decreasing costs.

Jeffrey Jerome Ludwig: Which levers you.

Jeffrey Jerome Ludwig: Contribute more to sales et cetera, and the non personal promotion actually it was.

Jeffrey Jerome Ludwig: Quite effective in terms of its impact on enrollments and things like that and as Jeff mentioned, it's much more cost effective as well. So I think as we increase non personal promotion you know we are increasing share of voice and increasing promotional sensitivity, while also decreasing costs and I'd add a little bit more color he'd been around.

Jeffrey Jerome Ludwig: And Ed, I'd add a little bit more color, even around the personal promotion, which is access being monetized in many cases in the community. But we've really worked hard to go back and evaluate those opportunities and try to make the right decisions that lend us to a much better ROI. So we're asking our field teams as leaders and owners of the business to make those trade-offs and choices to allow our dollars to go much farther than they have in the past. That's a big part of our efficiency.

Jeffrey Jerome Ludwig: On a personal promotion, which is all access is being monetized in many cases in the community, but we've really worked hard to go back and evaluate those opportunities and try to make the right decisions that lend us to a much better ROI. So we're asking our field teams as leaders and owners of the business to make those tradeoffs and choices too.

Jeffrey Jerome Ludwig: A lot of our dollars to go much farther than they have in the past that's a big part of our efficiency.

Speaker Change: Great. Thanks.

Jeffrey Jerome Ludwig: And just wanted to go back to the the lower starting dose because you're continually mentioned that by having the.

Jeffrey Jerome Ludwig: Great, thanks. And I just wanted to go back to the lower starting dose because you continually mention that by having the lower starting dose, with lower side effects, there'll be a lower rate of discontinuation. Can you put any numbers around that as far as the length of time that patients are staying on the drug or the number of refills that you're capturing that you weren't capturing before when you started on the higher dose?

Jeffrey Jerome Ludwig: Lower starting dose lower side effects.

Jeffrey Jerome Ludwig: There'll be a lower rate of discontinuation can you put any numbers around that as far as the length of time that patients are staying on drug or the number of refills.

Jeffrey Jerome Ludwig: That you are capturing that you wouldn't they werent capturing before.

Jeffrey Jerome Ludwig: Before when you're starting out at a higher dose.

Jeffrey Jerome Ludwig: Ed, great question. I think there are a couple things.

Speaker Change: Hey, Ed Great question, I think there's a couple of things one I would say overall, there's been a much better understanding of this molecule from customers now than in the past. So you can guess theres two ways of going about it we believe starting low and moving up based on a controlled data is the right way to do that and as we report.

Speaker Change: Somewhere around 70, plus or minus 5%, we see new patient starts there.

Jeffrey Jerome Ludwig: One, I would say overall that there's been a much better understanding of this molecule from customers now than in the past. So you can guess there are two ways of going about it. We believe starting low and moving up based on controlled data is the right way to do that. And as we report, somewhere around 70 plus or minus 5%, we see new patient starts there. As I look at persistence curves around any given month, we have about 5% to 10% more patients on the drug if they start with a lower dose.

Ed: As I look at persistence curves around any given month, we have about a five to 5% to 10% more patients on drug if they start with a lower dose now we monitor those cohorts on a regular basis. So there is fluctuations, but we do see lower discontinuation on any given month.

Jeffrey Jerome Ludwig: Now, we monitor those cohorts on a regular basis, so there are fluctuations, but we do see lower discontinuations on any given month for those that started low and increased as opposed to those that started high. I will say that there are customers that start high, and they simply reduce the dose as well, and you can achieve the same effect the same way, but our data suggests a lower dose does add to better persistence here.

Jeffrey Jerome Ludwig: For those it started low and increased as opposed to those that started high.

Jeffrey Jerome Ludwig: I will say that customers there are customers that do start high and they do simply reduce the dose as well then you can achieve the end the same way, but our data suggest a lower dose does add to a better persistence here.

Jeffrey Jerome Ludwig: And the other part I would add to this is that there are a number of HCPs who feel that they're okay managing the side effects of the drug when they start at a high dose, so they don't need to do the load. So I think at this juncture, you know, if I have to look at the roughly 70% who start at a low dose versus the 30% who don't, the 30% who don't, they just have the feeling of, I can manage it.

Jeffrey Jerome Ludwig: And then the other part I would add to this is you know there are a number of hcp's, who feel that they're okay, managing the side effects of the drug when they start at a high dose. So they don't need to do to the logos. So I think at this juncture you know if I have to look at the you know roughly 70% we started a low dose versus the <unk>.

Jeffrey Jerome Ludwig: 30% you don't the 30% you don't they just have the feeling of I can manage it I don't I don't need to.

Speaker Change: Okay. Thank you and my last question is just on you know.

Alan H. Auerbach: Okay, thank you. And my last question is just on, you know, for the last few quarters you've mentioned potential for licensing and business development. Can you just tell us what your benchmarks are, your hurdles are as you target potential partners or potential drugs to enlicense?

Alan H. Auerbach: For the last few quarters you've mentioned.

Alan H. Auerbach: Potential in licensing and business development.

Alan H. Auerbach: Can you just tell us what your benchmarks are your hurdles are for as you target potential partners or potential drugs to in license.

Alan H. Auerbach: Yeah.

Speaker Change: Yeah, I bet you that Ed.

Alan H. Auerbach: Yeah, happy to do that, Ed. So look, we obviously have a commercial. Salesforce that targets specifically breast cancer, and so that's kind of the focus, if you will. Obviously, anything we can add to that that focuses on that channel obviously makes the most sense, both from a clinical drug or one that's a commercial asset. We're casting a wide net from that perspective, obviously adding in a commercial asset if it's something that we can, you know, use our existing sales force to do, so we get the kind of economies of scale, if you will.

Alan H. Auerbach: Look we obviously have a commercial.

Alan H. Auerbach: Sales force that targets.

Alan H. Auerbach: Specifically breast cancer and so that's kind of the focus if you will.

Alan H. Auerbach: Obviously anything we can add to that that focuses on that channel. Obviously it makes the most sense both from a whether it's a clinical drug or one that's a commercial asset.

Alan H. Auerbach: We're casting a wide net from that perspective, obviously, adding in a commercial asset if it's something that we can you know.

Alan H. Auerbach: Use our existing sales force to do so I get the kind of economies of scale. If you will happy to look at things like that and obviously it can be EPS accretive, which is what we'd want it to do.

Alan H. Auerbach: I'm happy to look at things like that, and obviously, it can be EPS-secretive, which is what we'd want it to do. If it's something that's more of an R&D molecule, again, something focused in the breast space makes the most sense, so it's things that tend to be targeted at that. Obviously, in the community setting, you do tend to see sometimes that they treat breast and also lung cancer, so obviously lung cancer assets make sense from that perspective.

Alan H. Auerbach: Something that's more of an R&D molecule against something focused in the breast space. It makes the most sense. So there's things that tend to be targeted on that now obviously in the community setting.

Alan H. Auerbach: Do you tend to see sometimes that they treat breast and also lung. So obviously lung cancer as that makes sense that from that perspective as well.

Alan H. Auerbach: Okay.

Speaker Change: Okay. Thanks for taking my questions.

Alan H. Auerbach: Okay, thanks, Alan, for taking my question.

Alan H. Auerbach: Our next question comes from the line of Debbie of RA with TD Cowen. Please proceed with your question.

Divya Rao: Our next question comes from the line of Divya Rao with TD Cowan. Please proceed with your question.

Divya Rao: Good afternoon. This is giving you on for Mark I just had a quick question on the Alistair to trials.

Divya Rao: Good afternoon, this is Divya on behalf of Mark. I just had a quick question on the allosterative trials, specifically on the metastatic breast cancer trial. Are you guys planning to explore a biomarker strategy there for allosterative therapy, or are you planning on running phase two first and then kind of doing a post talk to figure out if that's an option forward? Thanks.

Divya Rao: On the metastatic breast cancer trial are you got plenty to explore a biomarker strategy there for Alistair Kid or are you planning on running the phase two first and then I'm kind of doing a post hoc to figure out if.

Divya Rao: Alright.

Alan H. Auerbach: Yeah, hi Divya, thank you for the call and for the question. We are definitely looking to implement a biomarker strategy. When we in-licensed Allocertib, one of the things that we made very clear was that, you know, due to the aurora kinase pathway, we know that there are certain biomarkers involved, like the ones that we've previously shown, such as, you know, C-Myc and RB1, where we know that aurora kinase plays a role, and that's where, in the small positive for two negative indications.

Speaker Change: Yeah, Hi, Thank you for the call for the question.

Alan H. Auerbach: We are definitely looking to employ a biomarker strategy when we in licensed <unk> at one of the things that we made very clear was that due.

Alan H. Auerbach: Due to the Aurora kinase pathway, we know that there are certain biomarkers involved like the ones that we've previously shown.

Alan H. Auerbach: Such as you know.

Alan H. Auerbach: Semic and RV, one where we know that Aurora kinase plays a role and that's where in small cell lung cancer trial. We saw the best efficacy of the drug we are definitely looking to do that in the breast study in the HR positive <unk> negative indication.

Alan H. Auerbach: In terms of the clinical trial right now Theres a biomarker analysis that is ongoing we're still waiting for those results to finalize where you can get some some question Matt.

Alan H. Auerbach: In terms of the clinical trial, right now, there's a biomarker analysis that's ongoing. We're still waiting for those results to finalize so we can get some clues from that. In the trial, what we would probably do is try to enrich for those types of biomarkers. So, again, the ones I would say would be anything involved in the Aurora kinase pathway. Admittedly, it's a very broad pathway. There are a lot of potential ones, you know, such as RB1, C-Myc, et cetera. So it is likely we would enrich for those biomarkers and go after a biomarker-focused indicator.

Alan H. Auerbach: And the trial, we would probably do is try to enrich for those types of Biomarkers. So again, you know the ones I would say it would be anything involved in the raw kinase pathway admittedly, it's a very broad pathway, there's a lot of potential ones such as RV once you make et cetera.

Alan H. Auerbach: So it is likely we would enrich for those Biomarkers and go after a biomarker focused indication.

Alan H. Auerbach: That's helpful. Thank you and then one quick question on the live interactions for narrowing.

Jeffrey Jerome Ludwig: And then one quick question on the live interactions for narrow links. Well, how would you, I guess, how close do you think those live interactions are returning to the pre-COVID levels? And then, kind of a follow up on the previous question. Is that a focus for you guys in terms of increasing promotion for narrow-lengths, or are you more focused on non-personal promotion?

Jeffrey Jerome Ludwig: How would you I guess.

Jeffrey Jerome Ludwig: How close do you think those live interactions are returning to the pre COVID-19 levels, and then kind of a follow up on the previous question.

Speaker Change: Is that a focus for us.

Jeffrey Jerome Ludwig: For you guys in terms of increasing promotion Bernero like where are you more focused on the non personal promotion.

Jeffrey Jerome Ludwig: Divya, I'd say, great question, both. So we want to increase both personal and non-personal, right? Oncology is a relatively restricted therapeutic area and, you know, being a small company, it can be more restrictive for us as well. So we want to see an increase in both personal and non-personal. So let me give you some more color there.

Jeffrey Jerome Ludwig: Debbie I would say, it's a great question. Both so we want to increase both personal and non personal right oncology itself is a relatively restricted therapeutic area and being a small company. It can be more restrictive for us as well. So we want to see an increase in both personal and non personal.

Jeffrey Jerome Ludwig: Let me, let me give you some more color. There you asked about live versus virtual we were about 81%, 82% live in this first quarter, we've been around that 80% to 85% live versus virtual.

Jeffrey Jerome Ludwig: You asked about live versus virtual. We are about 81%, 82% live in this first quarter. We've been around that 80% to 85% live versus virtual for a while. I think that mix is going to stay relatively the same.

Jeffrey Jerome Ludwig: I think that mix is going to stay relatively the same prior.

Jeffrey Jerome Ludwig: Prior to Covid, we were much higher in the high <unk> in terms of live interactions with very limited virtual.

Jeffrey Jerome Ludwig: Prior to COVID, we were much higher in the high 90s in terms of live interactions with very limited virtual. We are a smaller company, so our sales teams have large territories, so that's part of the efficiencies we like. If you can have an effective and efficient virtual call, that's one of the ways that I know Ed asked me earlier about being more efficient with travel and spend. If we can have an effective engagement, we're good at increasing both the virtual calls, and we're also working very hard to increase access to the live calls as well. Divya, this is Alan.

Alan: We are a smaller company. So our sales teams have large territory. So that's part of the efficiencies. We like if you can have an effective and efficient virtual call. That's one of the ways that I know I had asked me earlier about being more efficient with travel and spend if we can have an effective engagement. We're good increasing both the virtual calls and we're off.

Alan: Also working very hard to increase access around a live calls as well.

Alan H. Auerbach: In terms of your question about pre COVID, you know, remember that pre COVID, we really didn't have a lot of the technologies we now have and the implementation of those technologies for virtual interactions. So things like Zoom or Teams and things like that, they just really weren't being used much, which is why Jeff mentioned most of our pre COVID interactions were 95-97% live. In terms of which one is the focus, you know, as Jeff mentioned in his script, you know, HCP calls, you know, live calls in the first quarter increased, you know, 5% quarter over quarter.

Divya Rao: Yeah. This is Alan.

Speaker Change: What was your question of <unk>.

Alan H. Auerbach: Covid.

Alan H. Auerbach: That pre Covid, we really didn't have a lot of the technologies. We now have an implementation of those technologies for virtual interactions. So you know things like zoom or teams and things like that they just really weren't being used much which is why Jeff mentioned most of our pre COVID-19 interactions with 90, 597% lives.

Alan H. Auerbach: In terms of which one is a focus you know as Jeff mentioned in his script you know Hep's HCP calls they'll live calls in the first quarter increased 5% quarter over quarter, we were hoping for that number to continue to increase.

Alan H. Auerbach: We're hoping for that number to continue to increase. So, in no way, shape, or form are we looking to decrease our, you know, live interactions or our personal promotion. Just looking at, you know, from an investment perspective, which one is more effective and more efficient. And the non-personal promotion really allows us to cast a very broad net with the hope that it pulls people into some of our live interactions in a very cost-effective manner.

Alan H. Auerbach: In no way shape or form are we looking to decrease our live interactions or a personal promotion.

Alan H. Auerbach: Just looking at you know from an investment perspective, which one is more effective and more efficient and the non personal promotion. It really allows us to cast a very broad net with the hope that it pulls people into some of her alive interactions in a very cost effective manner.

Speaker Change: Alright, thank you so much.

Alan H. Auerbach: And our next question comes from the line of Gena Wang with Barclays. Please proceed with your question.

Operator: Thank you so much. And our next question comes from the line of Gina Wang with Barclays. Please proceed with your question.

Gina Wang: Hi, uh, this is Tony on for Gina. Uh, just one quick one on...

Operator: Hi, This is Tony on for Gena, just one quick one on the data for the Biomarkers. What should we expect are considered to be a positive signal and how would this kind of be used in order to offer the determined decisions and development.

Gina Wang: Yeah.

Gina Wang: Yeah. Thanks for the question Tony Yeah, you'll remember in the.

Alan H. Auerbach: Yeah, thanks for the question, Tony. You'll remember in the small cell lung cancer trial that was published in the Journal of Thoracic Oncology. You know, specifically in the biomarkers, which were the RB1, a loss of function mutation, and the CMIC amplified, you know, it was a randomized trial, so you saw a statistically significant increase in PFS and OS in those biomarkers. That's something I would consider to be positive, something where you're seeing that it differentiates from the rest of the patients.

Alan H. Auerbach: In the small cell lung cancer trial that was published in the journal of thoracic oncology.

Alan H. Auerbach: Specifically in the Biomarkers, which was the.

Alan H. Auerbach: Our b one loss of function mutation and seemed like amplified.

Alan H. Auerbach: The randomized trials. So you saw us statistically significant increase in PFS and OS in those Biomarkers, Yeah, that's something I would consider to be positive something where youre seeing that it differentiates from the rest of the patients. So I would say in this one and they're doing a much more vast biomarker analysis. So I would say anything of that kind of.

Alan H. Auerbach: So I would say in this one, they're doing a much more extensive biomarker analysis. So I would say anything that kind of rises up, if you will, in terms of either ORR or PFS showing that you're getting better activity in patients where there is some biomarker that would suggest that Aurora kinase is playing a role in driving that. That's what we would look for.

Alan H. Auerbach: Rises up if you will in terms of.

Alan H. Auerbach: Either or or or PFS, I'm, showing that youre getting better activity in patients where there is some biomarker that would suggest that Aurora kinase is playing a role in driving that cancer.

Alan H. Auerbach: That's what we would love to see.

Speaker Change: Got it thank you.

Alan H. Auerbach: Sure.

Alan H. Auerbach: This concludes our question and answer session and with that I would like to turn the conference back to Mariann for closing remarks.

Mariann Ohanesian: This concludes our question and answer session. And with that, I would like to turn the conference back to Mariann for her closing remarks.

Mariann Ohanesian: Thank you all for joining us today as a reminder, this call may be accessed via replay of the webcast and Puma biotechnology Dot com beginning later today have a good evening.

Mariann Ohanesian: Thank you all for joining us today. As a reminder, this call may be accessed via replay of the webcast at Pumabiotechnology.com, beginning later today.

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

Operator: Hum.

Operator: Okay.

Operator: Yeah.

Operator: Yes.

Operator: Yeah.

Operator: Yeah.

Operator: Hmm.

Operator: Hum.

Operator: Uh-huh.

Operator: Hum.

Operator: [music].

Operator: Hum.

Operator: Uh huh.

Operator: [music].

Operator: Hum.

Operator: [music].

Operator: Hum.

Operator: Hmm.

Operator: Yeah.

Operator:

Operator: Uh huh.

Operator: Okay.

Operator: [music].

Operator: ?? ?? ?? ?? ?? ?? ?? ? ? ? ? ? ? ? ? ? ? ? ?