Puma Biotechnology, Inc. (PBYI) Q4 2022 Earnings Report, Transcript and Summary

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

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. Maximo Nougues will then follow with highlights of the key components of our financial statements for the fourth quarter of 2022. 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 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 patients 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 would be able to 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 '23 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 '23. 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 '23, 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 '23. 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.

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 HCPs. Number two, engaging in educating patients around the risk of reoccurrence, as well as the risk benefit profile of NERLYNX. And finally three, 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 on 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 more 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 flows 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 of 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 have an impact on 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 insights 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 softened 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 turning the refills which influenced 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.

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 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 '22. 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 over bottles sold in Q1 as well as a higher gross to net due to the higher co-pay and coverage GAAP expenses that typically occur in the first quarter. The first quarter sales are also negatively impacted by patients delaying starting 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 bottle. 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 Siemens 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 level accrual due to the lawsuit settlement. The fourth quarter of 2022, Puma reported cash earned of approximately $3.1 million compared to cash earned 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 onetime cash flows 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 receivables 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 ulcerative and controlling our expenses.

Thanks, Maximo. As noted on our last earnings call, during 2022, we experienced increased face-to-face interactions with HCPs and better HCP 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 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. That continues to remain in a significant unmet need for patients battling breast cancer, lung cancer and other solid tumors. We have proven are committed and passionate about finding more effective ways and helping these patients during their journey, and we will continue to strive to achieve that goal. This concludes today's presentation. We will now turn the floor back to the operator for Q&A. Operator?

[Operator Instructions] Our first question comes from Divya Rao with Cowen and Company. Please state your question.

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 guess, like 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 you generate.

Yes. Thank you for the question. So alisertib, as you know, is an oral kinase A inhibitor. And our belief is that there's a number of pathways, which we highlighted previously on the call, like RB1 deficiencies and c-Myc and things like that, where we believe that the tumors that express those are going to be the best to target with alisertib. We've not yet gotten back a lot of the biomarker data, the biomarker data from the study of alisertib plus fulvestrant. My understand my trial, which is alisertib plus fulvestrant against alisertib alone. That 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 loan, we recently just got that data. So I think we are hoping for that. And again, these are investigator-sponsored trials. So they were done actual groups. I think we were hoping to have that in order to meet with the FDA because we just got it. We were -- had to move out for the second half.

That's helpful. Thank you.

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

Good afternoon. This is [Hao] calling in for Geoff Meacham. And thank you for the question. So my first one is really about for physicians to start patients at a reduced dose. What may be the main hurdles that you have seen? And what can we do to sort of improve that percentage of patients studied a reduced dose. And then the other one regarding the royalty revenue for that $12 million, I just wanted to hear if we can provide a bit more color about what sort of drives that number higher than the prior quarter and also the head from the prior year. Thank you.

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

Yes, happy to. Thanks for the question. Appreciate it. 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 talk about it consistently. It's been added to our package insert. It's been added to NCCN guidelines for both early stage and metastatic. And 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. And let me just give you some more color around that as we think about physicians who do adopt and those that don't adopt. There is certainly a group of physicians largely in a 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 will likely not going to start with a reduced dose. Number two, 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 got their own way of dealing with it. And so they start with 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 SP 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 SD channel. And so for example, if a patient starts in the SD portion of the business, it's not uncommon for them to fill one time in the SD channel and then move over to the SP channel for their second and subsequent fields. In that example, if the patient starts in dose escalation in the SD when they come over to the SP, 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. So these numbers, we believe, are very conservative. And quite honestly, I'm very happy with the overall trend. I would guess that the max that we'd ever see, I'm estimating might be 70%, 75%, that would be almost full adoption. So hopefully, that helps and add a little more color.

And then on your second question with regard to the royalty, a large portion of our royalty is the shipments to China. And those can fluctuate largely based on things such as you know, in China, they had the Zero COVID policy. And so a lot of times, it was -- we were just waiting for kind of the window to open for us to be able to ship. So that kind of causes that fluctuation in that bumpiness to occur. So that's largely why you saw the higher than expected in Q4.

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

Okay. Thank you. Very helpful.

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

Hi. Good afternoon. This is [Harshita] on for Gena. Thank you for taking our questions. A quick one from us. So it's been over a year since you reduced fuel clinical specialists right, given 50% to 60% of your accounts are through virtual interaction. I was wondering, can you give us an update on how this has been working out? Do you think you need to add back additional specialists? Or are you doing well with the current sales force? Thank you.

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 a very restricted specialty. 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 at some of the COVID offices -- obviously opening back up. So I will tell you 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 virtual. We monitor that very closely, and I've said this on previous calls, if we have an opportunity where we're not staffed correctly, where we can get in front of more physicians. Alan and I will have a very quick conversation on that, and we will adjust as necessary. But right now, we feel like we're managing the amount of accessible accounts and physicians either live or virtually, fairly effectively and efficiently. As I mentioned, we've seen calls -- overall calls increased quarter-over-quarter about 10% and actually year-over-year about 10%, looking at the fourth quarter. So we're happy with the current progress. And again, oncology specialty is restrictive. So we're also increasing our nonpersonal promotion to try to generate engagement with those clinicians that we cannot access. So hopefully, that helps a little bit.

Very helpful. Thank you so much.

Appreciate it.

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

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 small lung cancer discussions you're planning to have with the FDA in the first half of the year?

Yes, absolutely. Thanks for the question. In head to neck cancer, so 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 of using alisertib 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. I think trial is just kind of getting going on enrollment. So we'll expect to -- I would expect we'll probably have data if I to just ballpark it, probably Q3-ish of this year is probably when we start to see data, hopefully find a conference to present it some in the Q3, Q4 time frame. So I think once we get the data on that, we'll be more happy to comment on the opportunity. In terms of small cell lung cancer, you'll remember that there is a published study in the Journal of Thoracic Oncology of paclitaxel plus alisertib versus paclitaxel alone. Alisertib is an Aurora kinase inhibitor. So in a lot of the pathways, which are present in a pretty good percentage of the small cell lung cancer patients, which includes these things like RB1 deficiencies and RB1 mutations, c-Myc elevations and things like that. That's where the best efficacy was seen and that includes both a PFS benefit and an OS benefit in that trial. So I think what we'd like to have the discussion with the FDA on is kind of that biomarker-directed approach with the drug because our feeling is that's really going to be our opportunity to show the best risk benefit, the best possibility of showing the most maximum benefit, but also something that just differentiates alisertib from the other drugs in small cell lung cancer. Small cell lung cancer has been a tumor that has largely just consisted of various cytotoxic drugs. And other than the IO drug, you haven't really seen a biomarker-directed approach in small cell lung cancer the way you have in non-small cell lung cancer. Certainly, in non-small cell lung cancer, you have the EGFR mutations, the APP mutation, the last ones and things like that. You haven't really seen the same type of biomarker-directed approach in small cell lung cancer and that's really the approach we're looking to take. So that's where the discussion with the FDA is going to focus on.

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

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

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.

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.