Earnings Call Transcript - PBYI Q4 2022

Operator, Operator

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

Mariann Ohanesian, Senior Director of IR

Thank you, Diego. Good afternoon and welcome to Puma's conference call to discuss our financial results for the fourth quarter and full year 2022. Joining me on the call today are Alan Auerbach, Chief Executive Officer, President and Chairman of the Board of Puma; Maximo Nougues, Chief Financial Officer; and Jeff Ludwig, Chief Commercial Officer. After the market closed today, Puma issued a news release detailing fourth quarter 2022 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 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 the SEC from time to time, including our annual report on Form 10-K for the year ended December 31, 2022. 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, March 2, 2023. 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 2022 news release for a reconciliation of our GAAP to non-GAAP results. I will now turn the call over to Alan.

Alan Auerbach, CEO

Thank you, Mariann, and thank you all for joining our call today. Today, Puma reported total revenue for the fourth quarter of 2022 of $65.7 million. Total revenue includes product revenue net, which consists entirely of NERLYNX sales, as well as license fees and royalties from our sub-licensees. Product revenue net was $53.7 million in the fourth quarter of 2022, compared to $54.3 million reported in Q3 2022 and $51.0 million reported in Q4 of 2021. Product revenue for the fourth quarter of 2022 included approximately $2.6 million of inventory build in our specialty pharmacies and specialty distributors. Royalty revenue was $12 million in the fourth quarter of 2022, an increase from $2.8 million in Q3 of 2022 and an increase from $2.9 million in Q4 of 2021. We reported no license revenue in 2022. We reported 3,323 bottles of NERLYNX sold in the fourth quarter of 2022 compared to 3,197 bottles sold in Q3 of 2022. We estimate that Q4 inventory build amounted to approximately 164 bottles. In Q4 2022, new prescriptions were down approximately 16% compared to Q3 and total prescriptions were flat compared to Q3. 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 address additional color on NERLYNX commercial activities. As investors are aware, Puma had an ongoing basket trial of neratinib referred to as the SUMMIT trial which was testing neratinib in patients with metastatic HER2-negative hormone receptor positive breast cancer that has HER2 mutation. And in patients with metastatic non-small cell lung cancer that has an exon 18 mutation. As we mentioned to investors in the past, we believe that it was unlikely that the FDA would grant accelerated approval for neratinib based on the SUMMIT data and would instead require us to either one, do a head-to-head trial against standard of care in these indications or two, study neratinib in patient populations that do not overlap with other drugs in the rapidly changing treatment landscape. Based on recent precedence and interactions with the FDA, which suggested that regulatory approval in these indications would require a randomized trial, the company will not be further pursuing the development of neratinib in these indications. Due to the rarity of these mutations, enrollment and randomized studies would be challenging, and it is not clear that this could be accomplished in a timeframe that would result in a positive return for Puma shareholders based on the time and cost of the trial versus the potential market opportunity. The SUMMIT trial is therefore being discontinued, which results in a cost reduction from this trial in 2023 versus 2022. In September, Puma was pleased to announce that we in-licensed the anticancer drug alisertib from Takeda. In clinical trials to date, alisertib has shown single-agent activity and activity in combination with other cancer drugs in the treatment of various cancers including hormone receptor positive breast cancer, triple-negative breast cancer, small cell lung cancer, and head and neck cancer. The drug has also shown activity in previous clinical trials in peripheral T-cell lymphoma and non-Hodgkin's lymphoma. Takeda's previous clinical development program of alisertib was extensive. And due to this, there is a large well-characterized clinical safety database with over 1,300 patients who were treated across 22 company-sponsored trials. As mentioned in our last earnings call, Puma was in the process of transitioning the alisertib program from Takeda to Puma. This has now been successfully completed and the IND is currently being held by Puma. We are currently anticipating that we will be meeting with the FDA in the first half of 2023 to discuss the registration path for alisertib in small cell lung cancer and would subsequently anticipate initiating clinical trials of alisertib in small cell lung cancer in the second half of 2023. We further anticipate meeting with the FDA in the second half of 2023 to discuss the registration pathway for alisertib in hormone receptor positive HER2-negative breast cancer and subsequently initiating clinical trials of alisertib in hormone receptor positive HER2-negative breast cancer in the first half of 2024. We continue to anticipate that there will be several clinical milestones for the alisertib program in the coming months. This includes the publication of the biomarker studies from the randomized trial of alisertib plus fulvestrant versus alisertib alone in hormone receptor positive HER2-negative breast cancer, which we anticipate in the first half of 2023. Biomarker data from the randomized trial of alisertib plus paclitaxel versus paclitaxel alone in hormone receptor positive HER2-negative breast cancer, anticipated in the first half of 2023. Data from the ongoing investigator-sponsored Phase 1/2 trial of alisertib plus pembro for the treatment of patients with Rb-deficient head and neck squamous cell cancer, which is anticipated sometime in 2023. Conducting the meeting with the FDA to discuss the registration path for alisertib and small cell lung cancer, which is expected in the first half of 2023. And conducting the meeting with the FDA to discuss the registration path for alisertib and hormone receptor positive HER2-negative breast cancer, which is anticipated in the second half of 2023. 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. I will now turn the call over to Jeff Ludwig, Puma's Chief Commercial Officer, for a review of our commercial performance during the quarter.

Jeff Ludwig, Chief Commercial Officer

Thanks, Alan. Appreciate it. And I appreciate 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 commercial team remains focused on and passionate about helping to support more patients battling breast cancer. Our primary emphasis is on helping HER2-positive patients reduce their risk of recurrence in early-stage breast cancer. We would love to see more patients never become metastatic. Our strategy remains focused around three areas. Number one, communicating the evolving positive clinical data for NERLYNX to healthcare professionals. Number two, engaging in educating patients around the risk of recurrence, as well as the risk-benefit profile of NERLYNX. And finally, increasing our impact and share of voice through field force execution and non-personal promotion. Specifically regarding Q4, I'm very pleased that we saw Q4 year-over-year growth in our key metrics, including enrollments, new patient starts, and demand. In regards to share of voice, we also saw an increase in total calls comparing Q4 year-over-year as well as looking at Q4 versus Q3 of 2022. In Q4 about 80% of our total calls were live versus virtual, which is an increase from the 77% we reported in Q3 of 2022. In addition, our field teams increased their engagement with local and regional advocacy organizations, and we have remained very thoughtful and diligent about our overall expenses with the goal of being more efficient and effective. I am pleased with the progress being made but know that significant opportunities still remain in front of us. With that high-level update, let me transition to some of the U.S. commercial slides. Once I have finished, I will turn the call over to Maximo for a more detailed review of our financial results. Our distribution model has not changed. We have two channels that provide NERLYNX to patients. We refer to these as our specialty pharmacy channel and our specialty distributor channel or in-office dispensing channel. Most of our business continues to flow through the specialty pharmacy channel. In Q4, approximately 78% of our business went through this channel, with the remaining 22% of the business flowing through the specialty distributor channel. We do see some quarterly fluctuations in this mix, but no significant changes occurred throughout the year. Slide 4 shows U.S. quarterly net sales of NERLYNX since FDA approval. As Alan noted, our net product sales were $53.7 million in the fourth quarter of 2022. This is a $600,000 decrease over Q3 of 2022 and a $2.7 million increase over Q4 of 2021. Now inventory changes obviously impact these numbers. In Q4, we estimate that inventory increased by approximately $2.6 million in the fourth quarter of 2022. As a comparison, we estimated that inventory increased by approximately $5 million in Q4 of 2021. Turning to Slide 5. Slide 5 shows the bottles of NERLYNX sold by quarter since launch. Please remember that this slide shows ex-factory bottles sold, so it represents sales into our specialty pharmacy and specialty distributor channel and not end-user demand. We sold 3,323 bottles of NERLYNX in Q4 of 2022, which is about 4% higher than the bottles we reported in Q3 of 2022 and about 4% lower than the bottles we reported in Q4 of 2021. Let me again provide a little more insight around inventory changes. We estimate that inventory increased by about 164 bottles in the fourth quarter of 2022. As a comparison, we estimated that inventory increased by about 353 bottles in Q4 of 2021. The commercial team is focused on execution with the goal of driving both quarter-over-quarter growth and year-over-year growth. As previously mentioned, we saw our Q4 year-over-year growth across our key performance metrics including enrollments, new patient starts, and demand. We did not, however, see quarter-over-quarter growth for these same metrics. As a reminder, we historically have seen enrollments and new patient starts soften in the fourth quarter as physicians and/or their patients choose to initiate their therapy after the holidays in order to avoid the potential side effects of NERLYNX, which typically occur in the first month or so. Q4 of 2022 followed that traditional pattern of quarter-over-quarter decline. Let me provide some additional specifics around this performance. In Q4, we saw enrollments grow 1% year-over-year but declined 10% quarter-over-quarter in line with previous patterns. The year-over-year growth rates that I'm quoting are comparing Q4 of 2022 to Q4 of 2021. Moving on to new patient starts or NRx. We saw commercial new patient starts grow 7% year-over-year but declined 16% quarter-over-quarter. Commercial new patient starts are an important leading indicator for us as new patient starts turn into refills which influence subsequent quarters. Total prescriptions followed a somewhat similar trend with year-over-year being more positive than quarter-over-quarter. In Q4, we saw total RX growth 5% year-over-year and remained flat quarter-over-quarter. For the full year comparing 2022 to 2021, we saw enrollments grow approximately 2% and commercial new patient starts grow 4%. This is the first time since launch we have seen these positive yearly trends. Turning to Slide 6. We have continued to focus on the education and adoption of dose escalation. In Q4, approximately 64% of patients who received commercial drug started NERLYNX on a lower daily dose. This is a slight decrease from the approximately 68% we reported in Q3. Dose escalation can clearly benefit patients by significantly reducing the amount of Grade 3 diarrhea, the median days of Grade 3 diarrhea, and the overall discontinuation rate. We truly believe the adoption of dose escalation plays a very important role in reshaping the risk-benefit profile of NERLYNX. As previously reported, dose escalation was added to the NERLYNX label in late June of 2021 for both the extended adjuvant indication as well as the metastatic indication. In addition, NCCN updated their 2022 clinical practice guidelines to include dose escalation in early-stage breast cancer. I am pleased to say that NCCN recently updated their 2023 metastatic breast cancer guidelines and included dose escalation as an option in the metastatic setting as well. Now Slide 7 highlights the strategic collaborations we have formed across the globe. We are pleased with our global partners and the progress being made. In Q1 of 2023, NERLYNX received regulatory approval in the extended adjuvant setting in both Morocco and South Africa. Also in Q1 of 2023, we are happy to announce that NERLYNX was officially launched in Mexico in the extended adjuvant setting. Our global partners are focused on driving increased adoption and preparing for future launches. I look forward to highlighting their continued progress moving forward. In summary, 2022 was an important year for NERLYNX as the team worked hard to change some of the historical trends and build a solid foundation for future growth. I am pleased with the progress that was made in 2022, and I want to thank my commercial colleagues and the entire cross-functional Puma organization. The team is passionate about the work that we do and committed to finding more opportunities to support cancer patients along their journey. I will now turn the call over to Maximo for a review of our financial results.

Maximo Nougues, CFO

Thanks, Jeff. I will begin with a brief summary of our financial results for the fourth quarter of 2022. Please note that I will make comparisons to Q3 2022 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 2022 10-K which will be filed today and includes our consolidated financial statements. In the fourth quarter of 2022, we reported a net loss based on GAAP of $5.6 million or $0.12 per share. This compares to a Q3 2022 net loss of $0.4 million or $0.01 per share. Our fourth quarter 2022 results include an increase in our legal accrual due to a lawsuit settlement of $12.4 million. For the full year, we reported net income of $2,000. On a non-GAAP basis, which is included to remove the impact of stock-based compensation expense, we reported a net loss of $3 million or $0.07 per share for the fourth quarter of 2022. For the full year of 2022, our non-GAAP income was $11.8 million. Gross revenue from NERLYNX sales was $65.4 million in Q4 2022 and $63.4 million in Q3 2022. As Alan mentioned, net product revenue from NERLYNX sales was $53.7 million compared to the $54.3 million reported in the third quarter of 2022. We believe that Q4 net sales included approximately $2.6 million of inventory build from our distributors. Royalty revenue totaled at $12 million in the fourth quarter of 2022 compared to the $2.8 million in Q3 2022. Our gross-to-net adjustment in Q4 2022 was about 17.8% compared to the 14.3% gross-to-net adjustment reported in Q3 2022. Higher Medicaid rebates, government chargebacks, and higher co-pay were the drivers of the increase versus Q3 2022. Cost of sales for Q4 2022 was $16.8 million, including $2 million for the amortization of intangible assets related to our neratinib license. Cost of sales for Q3 2022 was $12.5 million. Going forward, we will continue to recognize amortization of milestones to the licensure of about $2.5 million per quarter as cost of sales. For fiscal year 2023, Puma anticipates that net NERLYNX product revenue will be in the range of $205 million to $210 million. We also anticipate that our gross-to-net adjustment for the full year 2023 will be between 19% and 20%. In addition, for fiscal year 2023, we anticipate receiving royalties from our partners around the world in the range of $25 million to $30 million. We don't expect license revenue in 2023. We also expect that net income for the full year will be in the range of $20 million to $24 million. We recognize there continues to be a great deal of uncertainty regarding the impact of COVID-19 especially in countries outside of the U.S., and this may continue to negatively impact our sales, royalties, and license revenue. Historically, the first quarter represents the lowest net product sales quarter of the year due to a number of factors, including inventory build in the channel in the fourth quarter of the prior year, which has a negative effect on bottles sold in Q1 as well as a higher gross to net due to the higher co-pay and coverage gap expenses that typically occur in the first quarter. The first quarter sales are also negatively impacted by patients delaying the start of NERLYNX during the fourth quarter of 2022, which Jeff described. We anticipate that for Q1 2023, NERLYNX net sales will be in the range of $43 million to $46 million. This guidance assumes that inventory is reduced by 200 bottles. We expect Q1 royalty revenues will be in the range of $4 million to $6 million, a decline from Q4. This decrease reflects the timing of shipments to our partner in China. We further estimate that the gross-to-net adjustment in Q1 2023 will be approximately 21% to 21.5%. Puma anticipates a Q1 net loss between $2 million and $5 million. SG&A expenses were $25.1 million in the fourth quarter of 2022 compared to $24 million for the third quarter. SG&A expenses included noncash charges for stock-based compensation of $1.8 million for the fourth quarter of 2022 compared to $2 million for Q3. Research and development expenses were $13.8 million in the fourth quarter of 2022 compared to $11.2 million for the third quarter. R&D expenses included noncash charges for stock-based compensation of $0.8 million in the fourth quarter of 2022 compared to $0.9 million for the third quarter. Our net loss for the quarter was impacted by an increase of $12.4 million to our legal accrual due to the lawsuit settlement. In the fourth quarter of 2022, Puma reported cash burn of approximately $3.1 million compared to cash burn of approximately $17.4 million in Q3 2022. Our Q4 2022 cash flow included a $7 million payment to Takeda that was made in October. For the full year, we reported cash burn of $10.6 million. If we exclude one-time cash flow events that impacted 2022, we would have seen positive cash flow of $36 million. On the expense side, Puma continues to anticipate a reduction in total operating expenses in 2023 compared to 2022. More specifically, we anticipate SG&A expenses to decline approximately 1% to 3%. And R&D expenses to increase 6% to 8% year-over-year. At December 31, 2022, we had approximately $81 million in cash, cash equivalents, and marketable securities. Our accounts receivable balance was $40.4 million. Our accounts receivable terms range between 10 and 68 days, while our days sales outstanding are about 46 days. We estimate that as of year-end 2022, our distribution network maintains 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.

Alan Auerbach, CEO

Thanks, Maximo. As noted on our last earnings call, during 2022, we experienced increased face-to-face interactions with healthcare professionals and better healthcare professional access overall, which we believe contributed to the increased commercial results that we saw in 2022. We are hopeful that this will continue to trend positively. Puma senior management, in cooperation with the Board of Directors, continues to remain focused on improving NERLYNX sales in 2023 and beyond. In the fourth quarter of 2021, we implemented a reduction in expenses with the goal of reducing expenses in order to maximize operating cash flows. We believe that the positive cash flow reported in the fourth quarter was a direct result of these expense reductions. These expense reductions are also a major contributor to the positive net income and positive cash flow that the company is guiding to for 2023. The company remains committed to continuing to achieve these operational cash flows and 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 are committed and passionate about finding more effective ways to help 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, Operator

Our first question comes from Divya Rao with Cowen and Company. Please state your question.

Divya Rao, Analyst

Hi, this is Divya on for Mark. Thanks for taking our question. I guess is there any specific data that you're hoping to generate before meeting with regulators to expand alisertib label in breast cancer? I think the prior guidance was H1 for both small cell and breast cancer. So I guess that's moved into Q2 or H2. So I was just wondering if there was any additional data you were hoping to generate.

Alan Auerbach, CEO

Yes. Thank you for the question. So alisertib, as you know, is an oral kinase A inhibitor. And our belief is that there are a number of pathways, which we highlighted previously on the call, like RB1 deficiencies and c-Myc, where we believe that the tumors that express those are going to be the best to target with alisertib. We've not yet received much of the biomarker data, specifically the biomarker data from the study of alisertib plus fulvestrant. My understanding is that trial, which is alisertib plus fulvestrant against alisertib alone, has been accepted for publication, and we're just waiting for the journal to publish that. The data on the paclitaxel plus alisertib against paclitaxel alone, we recently just got that data. I think we are hoping for that. Again, these are investigator-sponsored trials, so they were done by actual groups. We're hoping to have that data in order to meet with the FDA, but we had to push that out to the second half.

Divya Rao, Analyst

That's helpful. Thank you.

Operator, Operator

Thank you. Your next question comes from Geoff Meacham with Bank of America. Please proceed with your question.

Unidentified Analyst, Analyst

Good afternoon. This is Hao calling in for Geoff Meacham. Thank you for the question. My first inquiry is about the challenges physicians face when starting patients on a reduced dose. What are the main obstacles you've encountered, and how can we enhance the percentage of patients initiated on a lower dosage? Additionally, regarding the $12 million in royalty revenue, could you provide more insight into what factors led to that amount exceeding both the previous quarter and the same period last year? Thank you.

Alan Auerbach, CEO

Okay. On the first one, the reduced dose, Jeff, do you want to take that?

Jeff Ludwig, Chief Commercial Officer

Yes, happy to. Thanks for the question. Obviously, we think dose escalation is really important to the adoption of neratinib and the risk-benefit profile. Dose escalation has been very well received. Our teams discuss it consistently. It's been added to our package insert. It's been added to NCCN guidelines for both early stage and metastatic. We actually see very good discussions and support around dose escalation from our leading breast KOLs. So the question you're asking is, hey, why aren't we at, say, 100% adoption on the graph that we're showing? Let me just give you some more context around that as we think about physicians who do adopt and those that don't. There is certainly a group of physicians largely in the metastatic setting that believe you should start with full dose. They want to get full dose immediately upon treatment initiation. So there's a subset that is likely never going to start with a reduced dose. Secondly, we do have some physicians in the community that have dealt with neratinib for a long time that do not have challenges managing diarrhea, and they've developed their own methods of managing it. Hence, they start with the full dose and if they have a challenge, they dose reduce. The third situation is we believe the numbers that I'm showing you, although that methodology is very consistent, it really undercalls the complete adoption of dose escalation. We pull that data from our specialty pharmacy channel, which, as I mentioned before, is about 80% of our business, so it's a very good surrogate. We do not have visibility into the specialty distributor channel. In that example, if a patient starts in the specialty distributor portion of the business, it's not uncommon for them to fill one time in the specialty distributor channel and then move over to the specialty pharmacy channel for their second and subsequent fields. In that case, if the patient starts on dose escalation in the specialty distributor channel when they come over to the specialty pharmacy, it's likely they'll come at full dose, and we'll pick that up as a full dose start, even though they started on a low dose. Hence, we believe these numbers are very conservative. Quite honestly, I'm very happy with the overall trend. I would guess that the maximum that we'd ever see may be 70%, 75%, which would be almost full adoption. So hopefully that provides clarity around that and adds some additional context.

Alan Auerbach, CEO

And then on your second question with regard to the royalty, a significant portion of our royalty comes from shipments to China. Those can fluctuate largely based on events like the Zero COVID policy in China, which impacted our ability to ship. That kind of causes the fluctuation and bumpiness to occur. So that's largely why you saw the higher than expected in Q4.

Maximo Nougues, CFO

Sorry to add that. Also, we deliver batches, right? So large manufacturing budgets that won't become available when we ship as well.

Unidentified Analyst, Analyst

Okay. Thank you. Very helpful.

Operator, Operator

Thank you. Your next question comes from Gena Wang with Barclays. Please state your question.

Unidentified Analyst, Analyst

Hi. Good afternoon. This is Harshita on behalf of Gena. Thank you for taking our questions. We have a quick one for you. It's been over a year since you reduced the number of field clinical specialists, considering that 50% to 60% of your accounts are managed through virtual interactions. Could you provide us with an update on how this adjustment has been performing? Do you think there's a need to bring additional specialists back, or are you satisfied with the current sales force? Thank you.

Jeff Ludwig, Chief Commercial Officer

Yes. Harshita, thanks a lot for the question. I appreciate it. A couple of things. One is, as you know, the oncology therapeutic area is very restricted. It's more restricted than many other areas. I will tell you that since COVID, it's become even more restrictive, even though we're seeing some positive trends in terms of COVID offices opening back up. Right now, we feel very good about the size of our sales force. They're able to cover accounts that are open and accessible, either live or virtually. We monitor that very closely, and I've said this on previous calls, if we have an opportunity where we're not staffed correctly and can access more physicians, Alan and I will have a quick conversation about that, and we will adjust as necessary. But at present, we believe we're managing the amount of accessible accounts and physicians, whether live or virtually, fairly effectively and efficiently. As I mentioned, we've seen calls increase overall, both quarter-over-quarter and year-over-year about 10%, looking at the fourth quarter. So we're happy with the current progress. Again, oncology specialty is restrictive. We're also increasing our non-personal promotion to try to generate engagement with those clinicians that we cannot access. So hopefully, that helps a bit.

Unidentified Analyst, Analyst

Very helpful. Thank you so much.

Operator, Operator

Thank you. Your next question comes from Sahil Kazmi with B. Riley Securities. Please state your question.

Sahil Kazmi, Analyst

Hi Alan, thanks for taking our questions here. Just a couple from us. First of all, can you talk about how you're thinking about the opportunity in head and neck squamous cell cancer? Any color you can provide there as well as the discussions you're planning to have with the FDA in the first half of the year regarding small cell lung cancer?

Alan Auerbach, CEO

Yes, absolutely. Thanks for the question. In head and neck cancer, this is a study that's being done as an investigator-sponsored study. This was ongoing at the time that we purchased the drug from Takeda, where alisertib is being studied in combination with pembrolizumab in patients with RB deficient head and neck cancer. I think we're going to have to see the data before we can really comment on the opportunity. It's obviously a smaller tumor type. The trial is just kind of starting enrollment. I would expect we might have data around Q3-ish of this year, hopefully presenting somewhere in the Q3 or Q4 timeframe. Once we obtain the data, we'll be more than happy to comment on the opportunity. In terms of small cell lung cancer, there's a published study in the Journal of Thoracic Oncology of paclitaxel plus alisertib versus paclitaxel alone. Alisertib is an Aurora kinase inhibitor. In many of the pathways, which are present in a significant percentage of small cell lung cancer patients, we see the best efficacy in those patients, including both a PFS benefit and an OS benefit in that trial. What we'd like to discuss with the FDA is kind of a biomarker-directed approach with the drug because we feel that's going to provide the best potential to showcase the greatest benefit, and it differentiates alisertib from other drugs in small cell lung cancer. Small cell lung cancer has largely consisted of various cytotoxic drugs, and aside from the immuno-oncology drug, we haven't really seen a biomarker-directed approach in small cell lung cancer the way it exists in non-small cell lung cancer. Certainly, in non-small cell lung cancer, you have the EGFR mutations, the ALK mutations, and others. You haven't really seen the same type of biomarker-directed strategy in small cell lung cancer, and that's the approach we're pursuing.

Sahil Kazmi, Analyst

Excellent. That's very helpful. Congrats on all the progress and looking forward to following the story in 2023.

Operator, Operator

Thank you. And this concludes our question-and-answer session. I would like to turn the conference back to Mariann for closing remarks.

Mariann Ohanesian, Senior Director of IR

Thank you for joining us today. As a reminder, this call may be accessed via replay of the webcast at pumabiotechnology.com beginning later today. Have a good evening.

Operator, 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.