Good afternoon. My name is Alicia, and I'll be your conference call operator today. At this time, all participants are in a listen-only mode. After the speakers' formal remarks, there will be a question-and-answer session. [Operator Instructions] As a reminder, this call is being recorded. I would now like to turn the conference call over to Mariann Ohanesian, Senior Director of Investor Relations for Puma Biotechnology. You may begin your conference.

Thank you, Alicia. Good afternoon, and welcome to Puma's conference call to discuss our Financial Results for the Fourth Quarter of 2023. 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 fourth quarter and full year 2023 financial results. That news release with 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 the company'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 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, February 29, 2024. The company 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 also 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 fourth quarter 2023 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 fourth quarter of $72.2 million. Total revenue includes product revenue net, which consists entirely of NERLYNX sales as well as royalties from our sub-licensees. Product revenue net was $53.2 million in the fourth quarter of 2023, which was an increase from the Q3, 2023 and slightly below $53.7 million reported in Q4 2022. Product revenue for the fourth quarter of 2023 was impacted by approximately $2.1 million of inventory increase at all specialty pharmacies and specialty distributors. Royalty revenue was $19 million in the fourth quarter of 2023 was impacted by approximately $2.1 million of inventory increase at specialty pharmacies and specialty distributors. Royalty revenue was $19 million in the fourth quarter of 2023 compared to $4.5 million in Q3 of 2023 and $12 million in Q4 of 2022. We reported 2,881 bottles of NERLYNX sold in the fourth quarter of 2023, essentially unchanged from the 2,874 bottles sold in Q3 of 2023. In Q4 of 2023, we estimate that inventory increased by about 127 bottles. In Q4 of 2023, new prescriptions or NRx, were down approximately 9% compared to Q3, 2023, and total prescriptions, TRx, were down approximately 7% compared to Q3, 2023. Jeff will provide further details in his comments and slides. NERLYNX sales were negatively impacted by the decline in enrollments that we mentioned in our third quarter earnings call, a lower than anticipated rate of conversion from enrollment to commercial new patient starts and a higher than expected gross to net. Jeff and Maximo will discuss these two topics further in their comments. We have continued to reduce our internal expenses to account for these factors, as we recognize our fiscal responsibility to the shareholders and continue…

Thanks Alan. Appreciate it and thanks to everyone for joining our fourth quarter earnings call. Before I move into the commercial review, just a reminder that I will be making forward-looking statements. Let me again start with a high-level overview of our commercial strategy and then I will go into more details as we discuss specific slides. From a commercial strategy perspective, we believe that NERLYNX can benefit patients in the metastatic setting, but we remain heavily focused on early-stage breast cancer. We do not have direct competition in the extended adjuvant setting and believe that there remains significant unmet need, especially for patients who are deemed to be at higher risk reoccurrence. We want to see NERLYNX play a larger role in helping patients reduce derisk a reoccurrence and avoid metastatic disease. We believe NERLYNX continues to be promotionally sensitive. Our sales and marketing teams are working hard to expand their reach and frequency, both with personal and non-personal promotion. ACP calls in the fourth quarter increased about 12% year-over-year with about 80% of those calls being live interactions. In addition to pure call activity, we are using internal and external data to try and improve our abilities to engage with clinicians at the right time, given the various treatment decisions and duration of therapies. Finally, as a commercial organization, we remain committed to being more efficient and effective with our resources. We will continue to adapt to the changes in the business and the needs of the broader Puma organization. Let me now transition to some of the commercial slides, where I will provide some additional specifics around performance. Once I have finished, I will turn the call over to Maximo for a more detailed review of our financial results. Turning to slide 3. Slide 3 provides an…

Thanks, Jeff. I will begin with a brief summary of our financial results for the fourth quarter of 2023. Please note that I will make comparisons to Q3 2023 which we believe is a better indication of our progress as a commercial company than year-over-year comparisons. For more information, I recommend that you refer to our 2023 10-K which will be filed today and includes our financial statements. For the fourth quarter of 2023, we reported net income based on GAAP of $12.3 million or $0.26 per share. This compares to net income in Q3 2023 of $5.8 million or $0.12 per share. On a non-GAAP basis which is adjusted to remove the impact of stock-based compensation expense, we reported net income of $14.8 million or $0.31 per share for the fourth quarter of 2023. Gross revenue from NERLYNX sales was $64.9 million in Q4 2023 and $60.4 million in Q3 2023. As Alan mentioned it, net product revenue from NERLYNX sales was $53.2 million, an increase from the $51.6 million reported in Q3 2023. Q4 net sales were impacted by lower enrollments in Q3 as well as a higher gross to net in Q4. Inventory buildup by our distributors, was approximately $2.1 million in Q4, which was lower than expected versus approximately $0.6 million of buildup in Q3 2023. Royalty revenue totaled $19 million in the fourth quarter of 2023 compared to $4.5 million in Q3 2020. Higher royalties versus Q3 reflect the timing of shipments to our partner in China, as we noted last quarter. Our gross to net adjustment in Q4 2023 was about 18.1% compared to the 14.6% gross to net adjustment reported in Q3 2023. Higher medicare share, particularly from patients in Puerto Rico, the higher government charge backs were the main drivers of the…

Thanks, Maximo. We are pleased to report positive net income for the fourth quarter of 2023 and for full year 2023. Puma senior management in cooperation with the Board of Directors continues to remain focused on NERLYNX sales trends in 2024 and beyond and recognizes the 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 flows. We believe that the positive net income reported in the fourth quarter and for the full year 2023 reflects these expense reductions. The expense reductions that we have previously performed and continue to perform are also a major contributor to the positive net income that the company is guiding to for full year 2024. The company remains committed to continuing to achieve this positive net income, and we'll 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 at helping these patients during their journey, and we will continue to strive to achieve that goal. This concludes today's presentation. We will now turn the call back to the operator for Q&A. Operator?

Thank you. We will now begin the question-and-answer session. [Operator Instructions] Your first question comes from the line of Divya Rao with TD Cowen. Please proceed with your question.

Hi guys. Congrats On the quarter. This is Divya on for Mark. So I had a few questions on the Phase II trial in small cell lung cancer. One would be, I guess, in terms of the second half data disclosure, should we expect it to be at a medical meeting? Or do you think it could be a press release? And then my second question is I know you mentioned that the biomarker data, what's going to be one of the metrics that you use from the interim analysis to determine whether you move forward with talking with the FDA. Is the alisertib combo trial with paclitaxel, also the best bar to look at when you're looking at efficacy? And do you feel like you want to see both the biomarker and the efficacy data to kind of line up with that trial before moving forward with the FDA on future discussions? Thanks.

Yes. So Divya, thank you for your question. In terms of the disclosure, I would imagine there would be something more direct to investors not at a medical meeting because just present at medical meeting, you have to submit an abstract and there's a lead time there, and I'm not sure how much data we would have to submit to a medical meeting. So a medical meeting presentation, I would guess probably more of a 2025 event. But presenting that in some way, should perform to investors, that would be the way we would do this. And obviously, as much detail as we can. As we mentioned, we're going to be greatly increasing the number of sites this month. And so we're anticipating we're going to have a good number of patients to talk about. In terms of your second question, so obviously, in small cell lung cancer, you have both the chemotherapy sensitive group and the chemotherapy refractory group or the resistant group, so you get kind of two different, it's not totally homogeneous. I don't know that like cross-trial comparison is going to be like compared to this trial or that because it gets a little tricky in terms of prior treatments and things like that. I think the clear signal we're looking for is both response rate and PFS, but to see something that's better in the group that has the biomarker that doesn't from the early data. Because again, the thesis we have is that alisertib is an aurora kinase inhibitor, so the biomarkers that are involved in the euro kinase pathway is where we should see the best efficacy. That's really the signal we want to confirm because of different numbers and things like that, I'm not quite sure if we're going to want to do cross-trial comparisons quite yet. But in terms of the early data, that's really what we're going to be looking for is to see is there a biomarker subgroup that selects for the patients who are most likely to benefit from the drug.

Got it. That's helpful. Thank you.

Thank you. Our next question comes from the line of Gena Wang. Please proceed with your question. Q –Unidentified Analyst: Hi. Good afternoon. Thanks for taking our questions. This is Harshita on for Gena. I had a couple on alisertib. And Alan, you touched on this a little bit in the previous question but I kind of wanted to get some more color on what the efficacy bar would be for alisertib in the small cell trial. And I understand you disclosed that you don't want to make cost-out comparisons. But any color you can shed that on how you're thinking about alisertib especially in light of the DLL3 targeting agents are in development, including Amgen's Tarlatamab that has to produce later this year and HER2 that got taken over by Merck, they had shown some early results in Phase 1. So just keeping this in the background, I was curious if you could shed some color on how you're thinking about that.

Yeah. So with reference to the DLL3 drugs, Tarlatamab was a third line drug, so challenging from that perspective to try to compare a second line and third line. Also, I would say that while I recognize response rate, it's the typical thing people like to do cross-trial comparisons on. As you're aware, you can't just get approval on response rate. You need to actually show a magnitude of that benefit. So a PFS or Survival Benefit. So I think all of those are going to be important for us to look at. There is data on alisertib as a monotherapy that was published in Lancet Oncology previously. And off the top of my head, remembering it was like a 28% response rate and somewhere around three-month PFS and a non-selective group. So that would kind of be the most -- the only data we have for alisertib as a single agent, if you will. But trying to compare it to other agents, especially just looking at response rates, in small cell lung cancer, unfortunately, you've seen lots of drugs that have got really high response rate, but they can't confirm their clinical benefits because of no increase in PFS or OS. So I think, again, it's going to be really a totality of data where we want to see a response rate improvement, a PFS improvement and the PFS and the OS obviously, are going to be the ones going to be more important to us. Q –Unidentified Analyst: Got it. Thank you Alan, that's helpful. And then just a quick question again on alisertib, have you disclosed what the exact royalty percentages you owe to Takeda if the products are proved commercialized?

I do not have that in front of me in terms of our public disclosure. My recollection is we said something in the single-digit range, if I remember correctly. Q –Unidentified Analyst: Got it. Helpful. Thank you so much.

Thank you. There are no further questions at this time. I would like to turn the conference back over to Mariann, for closing comments.

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.