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

Thank you, Camilla. 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 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 Investors 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. 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, 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. 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.

Thank you, Mariann, and thank you all for joining our call today. Today, Puma reported total revenue for the first quarter of 2024 of $43.8 million. Total revenue includes product revenue net, which consists entirely of NERLYNX sales as well as royalties from our sublicensees. Product revenue net was $40.3 million in the first quarter of 2024, which was a decrease from the $53.2 million reported in Q4 2023 and below the $46.8 million reported in Q1 of 2023. Product revenue for the first quarter of 2024 was impacted by approximately $2 million of inventory drawdown 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 2023. We reported 2,410 bottles of NERLYNX sold in the first quarter of 2024, a decrease of 471 bottles from the 2,881 bottles sold in Q4 2023. In Q1 2024, we estimate that inventory decreased by about 120 bottles. In Q1 2024, new prescriptions were up approximately 27% compared to Q4 2023 and total prescriptions were down approximately 3% compared to Q4 2023. Jeff will provide further details in his comments and slides. NERLYNX 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 2024. I will now provide a clinical review of the quarter, then Jeff Ludwig will address color on NERLYNX commercial activities. Maximo Nougues will follow with highlights on the key components of our financial statements for the first quarter 2024. In February, we were pleased to announce that we initiated the ALISertib in Cancer or ALISCA-Lung1 trial, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer. This trial was previously referred to as Study PUMA-ALI-4201. The trial will enroll up to 60 patients with extensive stage small cell lung cancer who have progressed after first-line platinum-based chemotherapy and immunotherapy. Patients must provide tissue-based biopsies so that biomarkers can be analyzed. Alisertib will be dosed at 50 milligrams BID on days 1 through 7 of every 21-day cycle. 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 II study will be to confirm the efficacy of alisertib monotherapy in patients with small cell lung cancer with biomarkers where the aurora kinase pathway plays a role. The goal would be to correlate the efficacy in these biomarker subgroups in the ALISCA-Lung1 study to the efficacy that was previously seen in the biomarker subgroups from the randomized trial of paclitaxel plus alisertib versus paclitaxel plus placebo that was published in the Journal of Thoracic Oncology in 2020. If the efficacy and biomarker data are comparable from the 2 studies, the company believes it would represent a potential accelerated approval strategy and we'll engage the FDA to discuss this with. 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 2024. We also anticipate the initiation of ALISCA-Breast1, a Phase II trial of alisertib in combination with endocrine treatment in patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer in Q4 2024. We additionally anticipate 2 clinical data presentations on alisertib at the 2024 ASCO Annual Meeting in early June. Investors will remember that the Phase II trial referred to as TBCRC 41, which was a Phase II trial of alisertib bundle therapy versus the alisertib plus endocrine therapy in patients with HER2-negative hormone receptor-positive metastatic breast cancer was published in JAMA Oncology in 2023. As part of this trial, an analysis of biomarkers was performed in order to determine if the efficacy of alisertib in patients with HER2-negative hormone receptor-positive metastatic breast cancer correlates with any biomarkers. 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 alisertib given in combination with osimertinib in patients with metastatic EGFR-mutant non-small cell lung cancer. More specifically, patients who have metastatic EGFR-mutant non-small cell lung cancer are treated with osimertinib and at the time of progression, alisertib was added to osimertinib in order to see if alisertib can overcome osimertinib resistance. Interim data on this trial was previously presented at ASCO prior to Puma licensing the drug. Updated data on this trial will also be presented in 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 with a biomarker where the aurora kinase pathway plays a role, where alisertib appears to have much greater efficacy when added to osimertinib at the time of progression on osimertinib. 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. 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 alisertib, 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, 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.

Thank you, Alan, and I appreciate everyone joining our first quarter earnings call. Before I begin the commercial review, I want to remind you that I’ll be making forward-looking statements. The commercial team is primarily focused on the extended adjuvant indication, where the majority of NERLYNX sales and potential lie. A large number of early-stage HER2-positive breast cancer patients are treated in community settings, so our sales and marketing teams are working to enhance reach and frequency to targeted customers through both personal and nonpersonal promotion. In the first quarter, healthcare professional calls increased by about 5% compared to the previous quarter, with over 80% being live interactions. We are continuously evaluating new data and partners to improve our targeting and the timing of calls to make them more efficient and effective. We aim to raise awareness and education regarding the unmet needs in early-stage breast cancer and align with key customers to identify patients at higher risk of recurrence. The commercial team is dedicated to optimizing our resources and balancing the needs of NERLYNX with the broader objectives of the organization. I will now move to some commercial slides to provide additional details on performance. After I finish, I will hand it over to Maximo for a detailed look at our financial results. Slide 3 gives an overview of our distribution model, which remains unchanged and is divided into two main channels: the specialty pharmacy channel and the specialty distributor channel. Quarterly fluctuations are common, but most of our business goes through the specialty pharmacy channel. In Q1, approximately 74% of our business flowed through this channel, while the remaining 26% came from specialty distributors. This is consistent with what we reported in our Q4 earnings call. On Slide 4, NERLYNX net revenue for Q1 of 2024 was $40.3 million, reflecting a decrease of $12.9 million from the $53.2 million reported in Q4 2023 and a decline of $6.5 million from the $46.8 million reported in Q1 of 2023. Inventory changes will influence these comparisons, so let me share more details. In Q1 of 2024, we estimate a decrease in inventory of about $2 million, while in Q4 2023, we estimate inventory increased by around $2.1 million and decreased by approximately $3.8 million in Q1 of 2023. Slide 5 provides data on Q1 of 2024 ex-factory bottle sales and includes both year-over-year and quarter-over-quarter comparisons. In Q1 of 2024, NERLYNX ex-factory bottle sales totaled 2,410, marking a 16% decline from the previous quarter and a 15% decline compared to the same quarter last year. As for inventory changes, we estimate a decrease of about 120 bottles in Q1 of 2024, compared to an increase of approximately 127 bottles in Q4 of 2023 and a decrease of about 236 bottles in Q1 of 2023. Now, I’d like to share other metrics and insights regarding our first quarter performance. In Q1, new patient starts increased by about 27% quarter-over-quarter but were down about 15% year-over-year. Total prescriptions saw a 3% decline quarter-over-quarter and a 16% decline year-over-year. Overall demand decreased by approximately 8% quarter-over-quarter and about 18% year-over-year. As Alan mentioned, Q1 performance was negatively impacted by the decline in enrollments noted in our Q4 and Q3 earnings calls last year. Enrollments remain a crucial leading indicator as they transition into new patient starts, which then lead to refills driving demand in subsequent quarters. We experienced notable softness in enrollments in the latter half of 2023, largely driven by a decline in early Q3. Since then, we have observed improvements in enrollments, but they have not yet fully countered the impact we are seeing with bottles. In Q1, enrollments increased about 5% quarter-over-quarter but were down around 12% year-over-year. Our team is focused on achieving both quarter-over-quarter and year-over-year growth. Turning to Slide 6, we emphasize the adoption of dose escalation since launch. We believe this is a significant metric for NERLYNX. Patients starting at a reduced dose tend to experience substantially lower instances of grade 3 diarrhea and a lower rate of discontinuation. In Q1, about 67% of patients who received the commercial drug began NERLYNX at a reduced dose. While this is lower than the 76% reported in Q4 2023, it is higher than the figure from Q1 of 2023. Customer feedback remains positive, and the advantages of dose escalation continue to be a key commercial message. On Slide 7, we highlight our strategic collaborations around the globe. In Q1, NERLYNX received regulatory approval in Syria for the extended adjuvant setting and was officially launched in Morocco under the same setting. We greatly appreciate the dedication of our partners and remain focused on finding more ways to make NERLYNX accessible to additional patients worldwide. I want to conclude by expressing my gratitude to my colleagues at Puma for their support and commitment. Our team is passionate about making a meaningful difference in the lives of patients and their families facing cancer. We are dedicated to optimizing our resources and balancing both short-term and long-term priorities for Puma and its shareholders. I will now hand the call over to Maximo for an overview of our financial results.

Thanks, Jeff. 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 10-Q, which will be filed today and includes our consolidated financial statements. For the first quarter of 2024, we reported a net loss based on GAAP of $4.8 million or $0.10 per share. This compares to net income in Q4 2023 of $12.3 million or $0.26 per share. On a non-GAAP basis, which is adjusted to remove the impact of stock-based compensation expense, we reported a net loss of $2.4 million or $0.05 per share for the first quarter of 2024. Gross revenue from NERLYNX sales was $52.6 million in Q1 2024 and $64.9 million in Q4 2023. As Alan mentioned, net product revenue from NERLYNX sales was $40.3 million, a decline from $53.2 million reported in Q4 2023. Q1 net sales were impacted by lower enrollments in Q3 and Q4 as well as higher gross to net adjustment in Q1. Inventory drawdown by our distributors was approximately $2 million in Q1 versus approximately $2.1 million of buildup in Q4 2023. Royalty revenue totaled $3.5 million in the first quarter of 2024 compared to $19 million in Q4 2023. As expected, the lower royalties versus Q4 reflected timing of shipments to our partner in China, as we noted last quarter. Our gross to net adjustment in Q1 2024 was about 23.4% compared to the 18.1% gross to net adjustment reported in Q4 2023. Higher government chargebacks and higher copay were the main drivers of the increase versus Q4 2023. 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. Cost of sales for Q4 2023 was $24.3 million. Going forward, we will continue to recognize amortization of milestones to the licensor of about $2.4 million per quarter as cost of sales. For fiscal year 2024, Puma anticipates the net NERLYNX product revenue will be in the range of $183 million 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 inflation reduction on higher expected Medicaid remittance. In addition, for fiscal year 2024, we anticipate receiving royalties from our partners around the world in the range of $30 million to $33 million. We expect license revenue in 2024 in the range of $1 million to $2 million. We also expect that net income for the full year will be in the range of $12 million to $15 million. We anticipate that for Q2 2024, NERLYNX net product revenue will be in the range of $43 million to $45 million. Also, we expect Q2 royalty revenues will be in the range of $2.5 million to $3 million, and we anticipate no license revenue. We further estimate that the gross to net adjustment in Q2 2024 will be approximately 22% to 23%. Puma anticipates a Q2 net loss of between $6 million and $9 million. Due to our litigation expenses and a one-time alliterative expense, we expect higher expenses in Q2 and any other quarters in 2024. Due to these items, we are forecasting a net loss in Q2 but we anticipate that Puma will be net income-positive for the remainder of 2024 as well as for the full year. SG&A expenses were $21.8 million in the first quarter of 2024 compared to $20.2 million for the fourth quarter of 2023. 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 2023. Research and development expenses were $13.6 million in the first quarter of 2024 compared to $12.9 million in the fourth quarter of 2023. 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 2023. On the expense side, Puma anticipates flat 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 G&A expenses in Q2 to be significantly higher than in future quarters. In the first quarter of 2024, Puma reported cash earned of approximately $11.2 million. This compares to cash earned of approximately $10.4 million in Q4 of 2023. At March 31, 2024, we had approximately $107 million in cash, cash equivalents, and marketable securities versus about $96 million at year-end 2023. Our accounts receivable balance was $24.6 million. Our accounts receivable terms range between 10 and 68 days while our days sales outstanding are about 52 days. We estimate that as of March 31, 2024, our distribution network maintained approximately 4 weeks of inventory. Overall, we continue to deploy our financial resources to focus on commercialization of earnings, the development of alisertib, and controlling our expenses.

Thanks, Maximo. Puma's senior management in cooperation with the Board of Directors continues to remain focused on NERLYNX sales trends in 2024 and beyond and recognizes its fiscal responsibility to its shareholders to continue to maintain positive net income. In the fourth quarter of 2021, we implemented a reduction in expenses with the goal of maximizing operational cash flows. We believe that the positive net income that was seen in 2023 resulted from these expense reductions. The expense reductions that we have previously performed and continue to perform 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 this. We look forward to updating investors on this in the future. There continues to remain a significant unmet need for patients battling breast cancer, lung cancer, and other solid tumors. We at Puma are committed and passionate about finding more effective ways of helping these patients during their journey, and we will continue to strive to achieve that goal. This concludes today's presentation. We will now turn the floor back to the operator for Q&A.

Your first question comes from the line of Ed White with H.C. Wainwright.

I have a question regarding sales, specifically about the overall strategy. Alan and Jeff, you have mentioned before that sales are sensitive to promotions and that your selling, general, and administrative expenses will decrease this year. I would like to know how you are becoming more efficient and improving your drug promotion while also reducing costs.

Ed, yes, 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 we've 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 cost-effective, competitive ways of expanding our reach and frequency, both personal and non-personal, while paying attention to our costs associated with the goals of the organization.

Yes. And Ed, this is Alan. We did a recent analysis looking at both the personal and non-personal promotion aspects of the business and kind of which levers contribute more to sales, etc. 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.

And Ed, I’d add a little bit more color. Even around the personal promotion, which is access is being monetized in many cases in the community. 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.

Great. I just wanted to go back to the lower starting dose because you continually mention that by having the lower starting dose, 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 drug or the number of refills that you're capturing that you weren't capturing before when you're starting at a higher dose?

There's been a much better understanding of this molecule from customers compared to the past. We believe that starting with a low dose and gradually increasing based on controlled data is the best approach. Currently, around 70% of new patient starts fall into this category. When I examine the persistence rates for patients each month, we notice that those who begin with a lower dose have about 5% to 10% more patients continuing on the medication. We regularly monitor these groups, and while there are fluctuations, we observe fewer discontinuations each month among patients who start low and then increase their dose, compared to those who begin with a high dose. Some customers do start with a higher dose and then reduce it, achieving similar outcomes, but our data indicates that lower starting doses lead to better persistence.

And Ed, the other part I would add to this is, is 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 low dose. So I think at this juncture, if I have to look at the roughly 70% who start a low dose versus the 30% who don't, the 30% who don't, they just have the feeling of I can manage it; I don't need to.

Okay. And my last question is just on for the last few quarters, you've mentioned potential in-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 in-license?

Yes. I'm glad to address that, Ed. Our commercial sales force is specifically focused on breast cancer. This is our primary area of emphasis. Naturally, any additional assets that align with this focus, whether they are clinical or commercial, are our priority. We're exploring a variety of options, and if we can leverage our existing sales force for new commercial assets to achieve efficiencies, we are certainly open to that. Ideally, these would also be beneficial for earnings per share. For research and development, it's logical to prioritize molecules directed at breast cancer. We are particularly interested in solutions that address that market. It's also worth noting that within community settings, it’s common to see treatments for both breast and lung cancers, so we are also considering lung cancer assets.

Our next question comes from the line of Divya Rao with TD Cowen.

This is Divya on for Mark. I just had a quick question on the alisertib trials. Specifically on the metastatic breast cancer trial, are you guys planning to explore a biomarker strategy there for alisertib? Or are you planning on running the Phase II first and then kind of doing a post hoc to figure out the options forward?

Yes, thank you for the question. We are definitely looking to employ a biomarker strategy. When we in-licensed alisertib, one of the things that we made very clear was that due to the aurora kinase pathway, we know that there are certain biomarkers involved, like the ones that we've previously shown, such as c-Myc and RB-1, where we know that aurora kinase plays a role, and that's where in the 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, HER2-negative indication. 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 where 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's a lot of potential ones such as RB-1, c-Myc, etc. So it is likely we would enrich for those biomarkers and go after a biomarker-focused indication.

That's helpful. I have a quick question about the live interactions for NERLYNX. How close do you think those live interactions are to returning to pre-COVID levels? Additionally, is your main focus on increasing promotion, or are you more centered on non-personal promotion?

Divya, I would say 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. So let me give you some more color there. 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. I think that mix is going to stay relatively the same. 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 we can have effective and efficient virtual calls, 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 increasing both the virtual calls, and we're also working very hard to increase access around the live calls as well.

Divya, this is Alan. In terms of your question about pre-COVID, 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 that most of our pre-COVID interactions were 95% to 97% live. In terms of which one is the focus, as Jeff mentioned in his script, HCP calls live calls in the first quarter increased 5% quarter-over-quarter. We're hoping for that number to continue to increase. So in no way, shape, or form are we looking to decrease our live interactions or our personal promotion; just looking at it from an investment perspective, which one is more effective and efficient. 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.

And our next question comes from the line of Gena Wang with Barclays.

This is Tony on for Gena. Just one quick one on the data for the biomarkers. What should we expect or consider to be a positive signal? And how would this kind of be used in order to determine decisions in development?

Yes. Thanks for the question, Tony. You'll remember in the small cell lung cancer trial that was published in the Journal of Thoracic Oncology, specifically in the biomarkers, which was the RB-1, loss function mutation, and the c-Myc amplified, 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. So I would say in this one, they're doing a much more vast 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 cancer. That's what we would look to see.

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

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. 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.