PBYI - NASDAQ

Good afternoon. My name is Darrell 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 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 IR for Puma Biotechnology. You may begin your conference.

Thank you, Darrell. Good afternoon and welcome to Puma's Conference Call to discuss our Earnings Results for the Fourth 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 close date, Puma issued a news release detailing earnings results for the fourth quarter of 2024. That news release 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, 2024. 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 27, 2025. 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 fourth quarter 2024 earnings 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 2024 of $59.1 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 $54.4 million in the fourth quarter of 2024, which declined from $56.1 million reported in Q3 2024 and increased from the $53.2 million reported in Q4 2023. Product revenue for the fourth quarter of 2024 was impacted by approximately $3.7 million of inventory increase at our specialty pharmacies and distributors. Royalty revenue was $4.7 million in the fourth quarter of 2024 compared to $24.4 million in Q3 2024 and $19.0 million in Q4 2023. Royalty revenue in the third quarter of 2024 and fourth quarter of 2023 included the sales to China by our partner, Pierre Fabre. As we noted in our calls for those quarters, we reported 2,964 bottles of NERLYNX sold in the fourth quarter of 2024, an increase of 241 from the 2,723 bottles sold in Q3 2024. In Q4 2024, we estimate that inventory increased by about 205 bottles. In Q4 2024, new prescriptions NRx were down approximately 7% compared to Q3 2024, and total prescriptions TRx were up approximately 4% compared to Q3 2024. Jeff will provide further details in his comments and slides. I will now provide a clinical review of the quarter and then Jeff Ludwig will add additional color on NERLYNX commercial activities and Maximo Nougues will follow with highlights of the key components of our financial statements for the fourth quarter of 2024. There is currently an ongoing Phase 1 trial that is sponsored by the National Cancer Institute to evaluate the combination of neratinib and trastuzumab deruxtecan, otherwise known as in HER2 in patients with metastatic solid tumors. The Phase 1 trial includes patients with metastatic solid tumors harboring HER2 overexpression IHC 3+ ERBB2 amplifications or activating ERBB2 mutations. The primary objectives are to assess safety and tolerability of the combination, and the secondary objectives include evaluating pharmacokinetics, preliminary efficacy and potential biomarkers of response. We anticipate that interim data from this trial will be presented in the first half of 2025. In addition, Puma currently has two ongoing Phase 2 trials of our investigational drug alisertib. The first is the ALISCA-Breast1, which is a Phase 2 of alisertib in combination with endocrine treatment in patients with chemotherapy-naïve HER2-negative hormone receptor positive metastatic breast cancer, and the second is the ALISCA-Lung1 trial, which is a Phase 2 study looking at the efficacy of alisertib monotherapy patients with small cell lung cancer. As a reminder, the ALISCA-Breast1 trial investigates alisertib in combination with endocrine treatment. The endocrine treatment consists of either anastrozole, exemestane, letrozole, fulvestrant or tamoxifen in patients with chemotherapy-naïve HER2-negative hormone receptor positive metastatic breast cancer. Patients must have received previous treatment with a CDK4/6 inhibitor and received at least two prior lines of endocrine therapy in the recurrent or metastatic setting to be eligible for the trial. Patients are being dosed with alisertib at either 30 milligrams, 40 milligrams or 50 milligrams twice-daily on days 1 to 3, 8 to 10 and 15 to 17 on a 28-day cycle in combination with the endocrine therapy of the investigator's choice. Patients must not have been previously treated with the endocrine treatment that will be given in combination with alisertib in the trial. The primary efficacy endpoints include overall response rate, duration of response, disease control rate and progression-free survival. As a secondary objective, the company will be evaluating each of these efficacy endpoints within biomarker subgroups in order to determine whether any biomarker subgroup correlates with better efficacy, as has been seen in preclinical and clinical studies in other cancers, including breast cancer and small cell lung cancer. The company will then look to focus the future clinical development of alisertib in combination with endocrine therapy for patients with HER2-negative hormone receptor positive breast cancer in patients with these biomarkers. The trial was initiated in late November 2024. There are currently 22 sites that have been activated for the trial and the trial is enrolling ahead of expectations. There are currently 14 patients enrolled in the trial with four additional patients in screening. We look to have interim data from this trial later in 2025. With respect to ALISCA-Lung1, as discussed on the last conference call, the company believes that the data obtained to-date from the ALISCA-Lung1 trial is providing a preliminary indication of potentially better activity in patients with biomarkers where the aurora kinase pathway plays a role. The company recently met with members of the Steering Committee for the trial, and the committee recommended expanding enrollment in the trial to patients that have been treated with additional lines of prior treatment. As the current protocol limits enrollment in the trial to patients with up to two prior lines of therapy, the biomarkers that correlate with aurora kinase activity tend to be acquired as a mechanism of resistance to treatment. So by opening up the protocol to patients with additional lines of treatment, it will allow for enrichment of these biomarkers. The company is in the process of amending the protocol to allow for this. The company looks to have additional interim data from this trial later in 2025. 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 our existing R&D regulatory and commercial infrastructure. The company will keep investors updated on this as it progresses. I will now turn the call over to Jeff Ludwig, Puma's Chief Commercial Officer, for a review of our commercial performance during the quarter.

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. The HER2-positive breast cancer landscape is evolving, but there is no question that a significant unmet need remains. The Puma commercial team is committed to increasing the utilization of NERLYNX with a focus on patients that are deemed to have a higher risk of reoccurrence. Our teams are working very hard to increase our engagement with clinicians through both personal and non-personal promotion with a heavy emphasis on increasing engagement when treatment decisions are being made. Q4 call activity decreased quarter-over-quarter as expected given vacations and holidays, but did increase about 7% year-over-year. We are working with new partners, new data, and new approaches to not only continue to increase our share of voice, but also to improve the impact of those engagements. We are also exploring opportunities to better support patients who are on NERLYNX with the goal of appropriately maximizing persistence and compliance. All of us remain focused and are committed to becoming more efficient and effective with our resources and are committed to balancing the short-term and long-term goals of Puma and its shareholders. Let me now transition to some of the commercial slides where I’ll provide some additional specifics around performance. Once I have finished, I’ll turn the call over to Maximo for a more detailed review of our financial results. On Slide 3, we have an overview of our distribution model, which is broken out into the Specialty Pharmacy channel and the Specialty Distributor or in-office dispensing channel. We added BioCare to our SD distribution network in Q4 of 2024. BioCare is the exclusive distribution partner to the newest community oncology focus GPO. A significant portion of our business is driven by community oncologists so it made good sense to expand our network to further support these providers. In regards to the overall distribution of our business, in Q4 about 75% of our business was purchased through the SP channel and a remaining 25% was purchased through the SD channel. This is similar to what we reported during our Q3 earnings call. Now turning to Slide 4. NERLYNX net revenue in Q4 of 2024 was $54.4 million, which represents a decline of $1.7 million from the $56.1 million we reported in Q3 of 2024 and a $1.2 million increase from the $51.6 million we reported in Q4 of 2023. The significant changes in quarterly net revenue was driven primarily by four factors: Number one, inventory changes, two, higher U.S. ex-factory sales, three, a decrease in product supply revenue to our global partners, and four, a higher gross to net adjustment. I will provide some more details around product supply revenue and inventory changes and Maximo will provide some additional specifics during his update. In Q4 of 2024, we recorded product supply revenue of $800,000 versus $7.4 million in Q3 of 2024 and $5.3 million in Q4 of 2023. In Q4 of 2024, we estimate that inventory increase by about $3.7 million. As a comparator, we estimate that inventory increase by about $600,000 in Q3 of 2024 and increase by about $2.1 million in Q4 of 2023. Slide 5 shows Q4 of 2024 ex-factory bottle sales and also provides both a year-over-year and a quarter-over-quarter comparison. In Q4 of 2024, NERLYNX’s ex-factory bottle sales were 2,964, which represents an approximate 9% increase quarter-over-quarter and a 3% increase year-over-year. Similar to the prior slide, let me specifically call out the inventory changes from a bottle perspective. We estimate that inventory increase by 205 bottles in Q4 of 2024 and as a comparator we estimate that inventory increase by 37 bottles in Q3 of 2024 and increase by 127 bottles in Q4 of 2023. Let me just take a moment to provide additional metrics and insights into our fourth quarter performance. As a reminder, we historically have seen enrollments and new patient starts soften in the fourth quarter as physicians and/or patients choose to initiate their therapy after the holidays to avoid the potential side effects of NERLYNX, which typically occur in the first month or so. Q4 of 2024 followed that historical pattern. In Q4, we saw enrollments decline 7% quarter-over-quarter and about 10% year-over-year. New patient starts or NRx decreased 7% quarter-over-quarter, but increased 10% year-over-year. Turning to total prescriptions or TRx. We saw TRx grow 4% quarter-over-quarter and also grew 3% year-over-year. Finally, let me give you some more insights and specifics around demand. In Q4 we saw demand grow approximately 3% quarter-over-quarter. It also grew numerically higher, but was essentially flat as a percentage year-over-year, specifically, Q4 of 2024 versus Q4 of 2023. Moving to Slide 6. Slide 6 highlights the quarterly adoption of dose escalation since NERLYNX launch. In Q4, approximately 74% of patients started NERLYNX at a reduced dose. This is similar to the 76% we reported in Q4 of 2023, but higher than what we have reported in the last several quarters. Continued messaging and adoption of dose escalation is an important part of our commercial strategy. As a reminder, the control trial showed a significant reduction in Grade 3 diarrhea and improved persistence and compliance when patients were started at a lower dose. We tracked multiple cohorts of patients and continue to see improved compliance when patients are started at a lower dose. The commercial team continues to explore additional opportunities to better support patients throughout their entire NERLYNX therapy. Slide 7 highlights the strategic collaborations we have formed across the globe. In Q4, NERLYNX received regulatory approval in the extended adjuvant setting in Turkey and also received regulatory approval for both extended adjuvant and metastatic breast cancer in Thailand. We are also pleased to announce that NERLYNX was commercially launched in the extended adjuvant setting in both Turkey and Saudi Arabia. We really appreciate the excellent work being done by our partners around the globe and look forward to supporting their continued success moving forward. I’d like to wrap up by thanking my Puma colleagues for their passion and commitment to helping patients and their families battling breast cancers. We know all too well the devastating effects this disease can have and we’re committed to finding ways to increase our support of these patients throughout their journey. I’ll now turn the call over to Maximo for a review of our financial results. Maximo?

Thanks, Jeff. I will begin with a brief summary of our financial results for the fourth quarter of 2024. Please note that I will make comparisons to Q3 2024, which we believe is a better indication of our progress as a commercial company than year-over-year comparisons. For information, I recommend that you refer to our 2024 10-K, which will be filed today and includes our consolidated financial statements. For the fourth quarter of 2024 we recorded net income based on GAAP of $19.3 million or $0.39 per share. This compares to net income in Q3 2024 of $20.3 million or $0.41 per share. In the fourth quarter of 2024, we released a portion of our valuation allowance resulting in a non-cash deferred tax income benefit of $7.1 million. The valuation allowance was established to offset our deferred tax assets, which are primarily related to our historical losses. This significantly increased our net income for the quarter. On a non-GAAP basis, which is adjusted to remove the impact of stock-based compensation expense, we reported net income of $21.1 million or $0.43 per basic and diluted share for the fourth quarter of 2024. Gross revenue from NERLYNX sales was $66.5 million in Q4 2024 and $67.7 million in Q3 2024. As Alan mentioned, net products revenue from NERLYNX sales was $54.4 million, down slightly from the $56.1 million reported in Q3 2024. The lower net revenue was driven by two factors. Lower product sales, lower global partners as we recorded only $0.8 million in Q4 versus $7.4 million in Q3 and higher gross to net expenses. These were partially offset by higher U.S. demand and inventory build. Inventory increase by our distributors was approximately $3.7 million in Q4 versus an increase of approximately $0.6 million in Q3 2024. Royalty revenue totaled $4.7 million in the fourth quarter of 2024 compared to $24.4 million in Q3 2024, which included NERLYNX sales to China by our licensing partner Pierre Fabre. Our gross to net adjustment in Q4 2024 was about 18.2% compared to the 17.1% gross to net adjustment reported in Q3 2024. Cost of sales for Q4 2024 declined to $13.9 million and includes $2.4 million for the amortization of intangible assets related to our neratinib license. Cost of sales for Q3 2024 was $29.1 million, reflecting the sales of NERLYNX to China. Going forward, we will continue to recognize amortization of milestones to the licensor about $2.4 million per quarter as cost of sales. For fiscal year 2025, Puma anticipates that net NERLYNX product revenue will be in the range of $192 million to $198 million. We also anticipate that our gross to net adjustment for the full year 2025 will be between 20.5% and 21.5%. In addition, for fiscal year 2025, we anticipate receiving royalties from our partners around the world in the range of $20 million to $24 million. Lower than 2024 due to fewer shipments expected to China as our partner works through regulatory transitions during the first several quarters of 2025. We don't expect license revenue in 2025. We also expect that net income for the full year will be in the range of $23 million to $28 million. We are not forecasting any potential release of any additional tax asset valuation allowance in our net income estimate at this time. However, this will be evaluated on an ongoing basis. We will continue to keep investors updated on this as it progress. We anticipate that for Q1 2025, NERLYNX product revenue net will be in the range of $41 million to $43 million. Also, we expect Q1 royalty revenues will be in the range of $1.5 million to $2.5 million and no license revenue. To further estimate that the gross to net adjustment in Q1 2025 will be approximately $22.5 million to $23.5 million. Puma anticipates a Q1 net loss between $2 million and breakeven. As investors are aware, Q1 usually represents the lowest net product revenue of the four quarters due to the burn off of the inventory built from Q4. SG&A expenses were $16.6 million in the fourth quarter of 2024 compared to $16.8 million for the third quarter of 2024. SG&A expenses included non-cash charges for stock-based compensation of $1.3 million for Q4 and $1.5 million for Q3 2024. Research and development expenses were $15.2 million in the fourth quarter of 2024, an increase from $12.5 million in the third quarter of 2024. R&D expenses included non-cash charges for stock-based compensation of $0.5 million in the fourth quarter of 2024 and $0.6 million in the third quarter of 2024 On the expense side, Puma anticipates flat to a slightly lower total operating expenses in 2025 compared to 2024. More specifically, we anticipate SG&A expenses to decrease by 5% to 10% and R&D expenses to increase by 10% to 15% year-over-year. In the fourth quarter of 2024, Puma reported cash earned of approximately $4.3 million. This compares to cash burn of approximately $0.1 million in Q3 2024. Please note that during Q4, we made our term loan payment of $11.1 million related to our obligation with Ethereum. As a result of this, our total outstanding principal debt balance increased to approximately $67 million. At December 31, 2024, we had approximately $101 million in cash, cash equivalents marketable securities versus about $96 million at year end in 2023. Our accounts receivables balance was $32 million. Our accounts receivable terms range between 10 days and 60 days. Our day sales outstanding’s are about 48 days. We estimate that as of December 31, 2024, our distribution network maintained approximately four weeks of inventory. Overall, we continue to deploy our financial resources to focus on the commercialization of NERLYNX, the development of alisertib and controlling our expenses.

Thanks, Maximo. Puma Senior Management, in cooperation with the Board of Directors, continues to remain focused on NERLYNX sales trends in 2025 and beyond and recognizes its fiscal responsibility to shareholders to continue to maintain positive net income. We believe that the positive net income that was seen in fiscal years 2023 and 2024 resulted from the financial discipline across the company over the last few years. The expense reductions that we have performed and continue to perform are also a major contributor to the positive net income that the company achieved in Q4 2024 and that the company is guiding to for full year 2025. 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. Operator?

Thank you. [Operator Instructions] Our first questions come from the line of Ed White with H.C. Wainwright. Please proceed with your questions.

Good afternoon. Thanks for taking my questions. Alan, just wanted to ask a question on the Phase 1 MCI [ph] data within HER2. You had said that, you could see interim data in first half of 2025. Do you expect this to be presented at a medical conference, perhaps ASCO? Or is this something that you'd release, perhaps in a press release?

Yes. Hi, Ed. Thanks for the question. It has been submitted to, I apologize for my memory loss here. It was either AACR or ASCO. So one of those two. That's where I would expect it to be presented.

Okay, great. Thank you. And Jeff, you mentioned that you're trying to maximize persistence and compliance. Can you give us some statistics on what persistence and compliance is right now? How you're thinking about it and what are the steps that you're taking?

Yes, I appreciate it. Obviously, a couple things we're trying to do. One, from a clinical perspective, we are educating customers using clinical data that shows the benefits of patients finishing therapy or staying on therapy greater than 11 months. We have very good clinical data from the ExteNET study showing the benefits of that. We are working now to achieve that and extend that length of therapy. We are working very closely with our SP partners, all of our sales reps. Also we have reports looking at delayed refills, pending refills. So we're trying to educate, engage with customers throughout their entire journey to give them the best chance and the best support to stay on therapy throughout the recommended likely 12 months. Our marketing team is also creating an additional piece that really does a nice job of highlighting all the benefits and support that we can offer a patient throughout their journey. And that will be shipped with all refills coming here very quickly here in 2025. From a data perspective, Ed, you've asked me this question, let me give you some more color here. As I look at dose escalation again, being another part of increasing that persistence and compliance. As I look at the most recent cohorts of data that we've talked about previously, we continue to follow multiple cohorts of data. And whether I look at a three month cohort that started a year ago, following that three month cohort from a year ago till now. If I back up a little farther, looking at a six month cohort following that six month group of patients out a year and even a nine month, what we see every step of the way, we see now about a 5% to 10% more patients remaining on therapy if you start at a lower dose than if you started on full dose. So that is contributing to us extending that length of therapy a little bit and giving us some benefits on our forecast as well. Is that helpful?

Yes, it is. Thank you. And I just wanted to, the revenue guidance for the year is sort of flattish, I guess, how are you thinking about price versus volume in that guidance?

So Ed, a couple of things as I think Maximo shared as well. There's a couple things going on there with guidance. One is, we do see a decrease in product supply revenue in 2025 versus 2024. We did take price, that's already been announced. We did take price in early Q1 of 2025. We announced that that was a 7% price increase. As I think about just pure demand, last year if you look at the demand that we reported, demand declined about 9% or 10% year-over-year. We are forecasting to a demand decline currently of about 2%. Now that's in our guidance. Obviously, it's my job to not let that happen and exceed that. But we're forecasting to a demand decline of about 2% year-over-year.

Okay, great. Thanks, Jeff. And my last question is just when thinking about, the royalty stream from outside of the U.S. How should – you had mentioned China would be down? Do we think about China being lumpy as we've seen in the past with just boluses of revenue and then nothing again for 2025 [ph]?

Yes. Ed, so you're correct. In all of our revenue streams that we get from royalties, we get paid basically as the drug is sold. So it's just a straight royalty. China's a little bit different, because it's sold through a distribution network. So we basically sell it to our partner and then once it's sold to them, they put it into the distribution network. So it's not as directly time related, demand driven. So we're in the – as Maximo mentioned in his script, we're in the process of having the official registration authorization transferred from us to Pierre Fabre. So we kind of built up some inventory ahead of that. So, I would expect the shipments to be a little bit lower in 2025. And that's one of the reasons you see the, decline in royalties year-over-year. And to answer your question. Yes, it would be kind of lumpy as well.

And Alan, let me just add one more piece. As we look at China, the one thing I do want to comment, Alan's talking about the lumpiness we do pay attention to in-market demand. And in-market demand continues to be on track with previous estimates and is still forecasted to grow as we had previously saw. So we do not have a demand reduction in China.

Okay, great. Well, thanks for taking my questions.

Thank you. Our next questions come from the line of Marc Frahm with TD Cowen. Please proceed with your questions.

Hi. Thanks for taking my questions. Maybe one on the commercial side, just there's the second part of the IRA's Part D redesign and other kind of payment reforms this year. Just any impact you're seeing in the early returns here in the first couple of months of the year in terms of how the patients are experiencing reimbursement?

Yes. Marc, we're not seeing an overall big impact. One is, when you think about that reform, what I will tell you is, our distribution of Medicare patients and the trends on Medicare patients have been fairly stable. Our length of therapy on Medicare is fairly consistent. So we're not seeing a significant change in trends that we have seen prior based on the IRA reform at this point in time.

Okay, that's helpful. And then maybe just on the breast cancer trial for alisertib, just the interim data, can you kind of run through the expectations there for remind us just how much data you expect to be able to share at that interim?

Yes, Marc, I think we'll have a better idea of like number of patients and things like that. Probably next earnings call or so. But again, they're being randomized to one to three doses. So obviously we would have probably some, early response, early duration data. If you look at the most recent trial that was done, which is the TBCRC 041 trial, the median PFS there was like five and a half months. So, assume for a patient that's coming out in March, if that's the PFS they see, we're not going to see that end for quite some time. So a lot of it would probably be ongoing data where it's kind of a plus next to the number, that would be something to anticipate.

Okay, thanks. Very helpful.

Thank you. Our next question is come from the line of Gena Wang with Barclays. Please proceed with your questions.

Hi, thanks for taking my question. This is [indiscernible] on behalf of Gena Wang from Barclays. I just want to follow up with the HER2 cancer for the ALISCA, Phase 2 trial. So I'm curious, like, what's your bar regarding the efficacy and the safety you want to hit in this trial?

Yes. Can you clarify which trial you're referring to? Are you referring to the breast or the lung?

The breast.

Yes. So, the best marker for expectations for the breast trial would probably be the TBCRC 041 trial. We're doing the same dose. So the TBCRC 041 trial was 50 milligrams of alisertib given bid, same dosing schedule, three days a week for three weeks in a 28 day cycle. That would probably be the best bar. Now, again, we're going, 30 milligrams, 40 milligrams, 50 milligrams. So, there's a reason for doing that. We're trying to look for if there's a, dose response and to satisfy, Project Optimus from the FDA. So that would probably be the bar I would look to as the comp.

Yes, thanks, that's helpful.

Thank you. That concludes our question-and-answer session. I would now like to turn the conference back over 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.