Puma Biotechnology, Inc. (PBYI) Q3 2022 Earnings Report, Transcript and Summary

Good afternoon. My name is Paul 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 over to Mariann Ohanesian, Senior Director of IR for Puma Biotechnology. You may begin your conference.

Thank you, Paul. Good afternoon and welcome to Puma’s conference call to discuss our financial results for the third quarter of 2022. Joining me on the call today are Alan Auerbach, Chief Executive Officer, President and Chairman of the Board of Puma Biotechnology; Maximo Nougues, Chief Financial Officer; and Jeff Ludwig, Chief Commercial Officer. After market closed today, Puma issued a news release detailing third 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, 2021 and our quarterly report on Form 10-Q for the period ended September 30, 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, November 3, 2022. 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 third 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 third quarter of 2022 of $57.1 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 $54.3 million in the third quarter of 2022, which represents an increase from the $51.3 million in product revenue net reported in the second quarter of 2022 and $43.4 million in product revenue reported in Q3 2021. Product revenue for the third quarter of 2022 included approximately $0.5 million of inventory build at our specialty pharmacies and specialty distributors. Royalty revenue was $2.8 million in the second quarter of 2022, a decrease from $8.2 million in Q2 2022 and equal to the $2.8 million recorded in Q3 of 2021. We recorded no license revenue in the latest quarter. We reported 3,197 bottles of NERLYNX sold in the third quarter compared to 3,200 bottles sold in Q2 of 2022. We estimate that the Q3 inventory build amounted to approximately 31 bottles. In Q3 2022, new prescriptions, NRx, were up approximately 17% compared to Q2 and total prescriptions, TRx, were up about 5%. 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 follow with highlights of the key components of our financial statements for the third quarter of 2022. As investors are aware, there is an ongoing clinical trial of neratinib that is being run by the Translational Breast Cancer Research Consortium, TBCRC, known as TBCRC 022 that is testing neratinib in patients with HER2-positive metastatic breast cancer that has metastasized to the brain. The results from the prior cohort of the trial, which tested neratinib plus capecitabine in patients with brain metastasis, resulted in neratinib being listed in the NCCN guidelines for the treatment of breast cancer that has metastasized to the brain. The current cohort of the trial is testing the combination of neratinib plus Kadcyla in patients with HER2-positive breast cancer that has metastasized to the brain. The results from two cohorts of this trial, which tested the combination in patients who have not previously been treated with Kadcyla and in patients who have previously been treated with Kadcyla, will be presented at the San Antonio Breast Cancer Symposium in December. As investors are also aware, Puma has an ongoing basket trial of neratinib in HER2 mutated cancers with HER2 as the SUMMIT trial. Puma plans to meet with the FDA in the first half of 2023 to discuss the potential regulatory path for neratinib for two arms of this trial. Patients with hormone receptor positive HER2-negative breast cancer who have a HER2 mutation in patients with metastatic non-small cell lung cancer with epidermal growth factor or EGFR, exon 18 mutations, who have previously been treated with an EGFR tyrosine kinase inhibitor. 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 many different types of 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 with 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. Puma is currently in the process of transitioning the alisertib program from Takeda to Puma. We anticipate that the majority of this will be completed by the end of the year. 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 is expected in Q4 2022. Biomarker data from the randomized trial of alisertib plus paclitaxel versus paclitaxel alone in hormone receptor positive HER2-negative breast cancer, which is anticipated in the first half of 2023 and data from the ongoing investigator-sponsored Phase 1/2 trial of alisertib plus pembrolizumab for the treatment of patients with Rb-deficient head and neck squamous cell cancer, which is also anticipated in 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 Puma’s 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 third quarter earnings call. Before I move into the commercial review, just a reminder that I will be making forward-looking statements. The commercial team continues to focus on helping to support more patients battling breast cancer. Our goal is to increase the appropriate adoption of NERLYNX and ultimately generate consistent growth. Our strategy has not changed and remains focused around three areas. Number one, communicating the evolving positive clinical data for NERLYNX to HCPs; number two, engaging and 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. I stated on the Q2 earnings call that I felt progress was made on all 3 fronts. I am pleased to say that progress has continued in Q3 as well. Additional tools and resources were rolled out to further support our clinical story. HCP calls per day continued to increase, and our field teams further engaged with local and regional advocacy organizations. In addition, we saw continued growth in live versus virtual interactions. More specifically, in Q3, approximately 77% of HCP calls were live versus virtual. Lastly, we saw NERLYNX added to more community oncology practice pathways in Q3, which we believe will further support our efforts at increasing adoption moving forward. With that high-level update, let me transition to some of the U.S. commercial slides. Once I am finished, I will turn the call over to Maximo for a more detailed review of our financial results. Starting with Slide 3, 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 flows through the specialty pharmacy channel. In Q3, approximately 80% of our business went through this channel, with the remaining 20% of the business flowing through the specialty distributor channel. We do see slight quarterly fluctuations of this mix, but no significant changes have occurred this year. Moving to Slide 4. Slide 4 shows U.S. quarterly net sales of NERLYNX since FDA approval. As Alan noted, our net product sales were $54.3 million in the third quarter of 2022. This is a $3 million increase from the $51.3 million reported in Q2 of 2022. There was a small inventory increase in Q3, which we estimate contributed about $500,000 of this increase. On Slide 5, you see the bottles of NERLYNX sold by quarter since launch. Please note 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 3,197 bottles of NERLYNX in Q3 of 2022, which is almost identical to our Q2 ‘22 bottle sales of 3,200. In Q3, we estimate that inventory increased by about 31 bottles. Please recall that we saw an inventory build in Q2 of approximately 175 bottles, which is impacting this quarter-over-quarter comparison. The commercial team has been focused on execution with the goal of driving both quarter-over-quarter growth and year-over-year growth. Q3 performance aligns with that aspiration in that we saw both quarter-over-quarter and year-over-year growth for enrollments, new prescriptions, or NRx, as well as total prescriptions, TRx. Now let me provide some additional specifics around this performance. In Q3, we saw enrollments grew 7% quarter-over-quarter and 12% year-over-year. The year-over-year growth rates I’m quoting are comparing Q3 of ‘22 to Q3 of ‘21. Moving on to new patient starts or NRx, we saw 17% quarter-over-quarter growth and 19% year-over-year growth. As we’ve discussed previously, NRx is an important leading indicator for us as new patient starts turn into refills, which influence subsequent quarters as well. This positive trend continued when looking at total prescriptions or TRx, total prescriptions grew about 5% quarter-over-quarter and about 2.5% year-over-year. This is the first time since launch we have seen positive growth in enrollments, NRx and TRx, for both quarter-over-quarter and year-over-year comparisons. Moving to Slide 6, we have continued to focus on the education and adoption of dose escalation and are pleased with the progress being made. 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 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 last year 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. As you can see on Slide 6, we continue to see an increase in the adoption of dose escalation. In fact, in Q3, approximately 68% of patients who received commercial drug started NERLYNX on a lower daily dose. 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 Q3, NERLYNX received regulatory approval for metastatic breast cancer in both Ecuador and Singapore and was officially launched in Brazil and Spain. The launches in Brazil and Spain were both 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 with the goal of making NERLYNX available to more patients around the world. Puma was founded on a commitment to making a difference in the lives of patients and their families battling breast cancer. We are inspired by the courage and the strength exhibited by many of these patients and are committed to doing more to better support their journey. I want to take just a moment to thank my commercial colleagues and the entire cross-functional Puma organization. I am inspired by their passion and steadfast determination to make a difference and to do more. I will now turn the call over to Maximo for a review of our full financial results.

Thanks, Jeff. I will begin with a brief summary of our financial results for the third quarter of 2022. Please note that I will make comparisons to Q2 2022, which we believe is a better indication of our progress as a commercial company, then year-over-year comparisons. For more information, I recommend that you refer to our Q3 2022 10-Q, which will be filed today and includes our consolidated financial statements. For the third quarter of 2022, we reported a net loss based on GAAP of $0.4 million or $0.01 per share. This compares to our Q2 2022 net income of $9.4 million or $0.21 per share. On a non-GAAP basis, which is adjusted to remove the impact of stock-based compensation expense, we reported net income of $2.5 million or $0.05 per share for the third quarter of 2022. Gross revenue from NERLYNX sales was $63.4 million in Q3 2022 and $63.4 million in Q2 2022. As Alan mentioned, net product revenue from NERLYNX sales was $54.3 million compared to $51.3 million reported in the second quarter of 2022. We believe that Q3 net sales included approximately $0.5 million of inventory build from our distributors. Royalty revenue totaled $2.8 million in the third quarter of 2022, a decrease from $8.2 million in Q2 2022. Our gross to net adjustment in Q3 2022 was about 14.3% compared to the 19% gross to net adjustment in Q2 2022. Continued lower Medicaid share, high inflation and lower co-pay due to seasonality are the main drivers to the decline versus prior quarter. Cost of sales for Q3 2022 was $12.5 million, including $2 million for the amortization of intangible assets related to our neratinib license. Cost of sales for Q2 2022 was $14.9 million. Going forward, we will continue to recognize amortization of milestones to the licensor for about $2 million per quarter as cost of sales. For fiscal year 2022, Puma is increasing its previous guidance, now expecting that net NERLYNX product revenue will be in the range of $194 million to $196 million. We also anticipate that our gross to net adjustment for the full year 2022 will be between 18% and 19%, slightly better than our prior guidance. Furthermore, for the fiscal year 2022, we anticipate receiving royalties from our partners around the world in the range of $25 million to $27 million, lower than our prior guidance due to the timing of our NERLYNX shipments to our partner in China and potential negative foreign exchange impact. We don’t expect license revenue in 2022. In addition, we are narrowing our prior full year net income guidance to a range of $7 million to $9 million for the year. We recognize there continues to be a great deal of uncertainty regarding the impact of COVID-19, and this may continue to negatively impact our sales, royalties and license revenue. We anticipate that for Q4 2022, NERLYNX net sales will be in the range of $48 million to $50 million. This guidance assumes that inventory in Q4 will increase as we have seen in prior years. This guidance also assumes that we will see a sequential decline in new patient starts in Q4 around the holidays as we have seen in prior years due to the side effect profile of the drug. We tend to see that many patients delay starting NERLYNX until after the holidays, which causes a seasonal decline in new patient starts in Q4. We expect Q4 royalties revenue will be in the range of $9 million to $11 million. This is an increase in royalty revenue compared to Q3. This increase is caused by the timing of shipments to our partner in China, as we explained during our prior call. We further estimate that the gross to net adjustment in Q4 2022 will be approximately 18.5% to 19.5%. Puma anticipates Q4 net income between $1 million and $3 million. SG&A expenses were $24 million in the third quarter of 2022 compared to $20.6 million for the fourth quarter – for the second quarter. SG&A expenses included non-cash charges for stock-based compensation for $2 million for the third quarter of 2022 compared to $2.1 million for Q2 2022. Research and development expenses were $11.2 million in the third quarter of 2022 compared to $12 million for the second quarter. R&D expenses included non-cash charges for stock-based compensation of $0.9 million in the third quarter of 2022 compared to $1.1 million for the second quarter. In Q3 2022, we recorded $7 million as acquired in-process research and development expenses to reflect the $7 million upfront payment to Takeda. In the third quarter of 2022, Puma reported cash burn of approximately $17.4 million compared to cash burn of approximately $14 million in Q2 2022. Our Q3 2022 cash burn does not include the $7 million payment to Takeda as it was executed in October. As a result of cost containment actions across the company implemented in the fourth quarter of 2021, Puma continues to expect lower operating expenses in 2022 compared to 2021. More specifically, we anticipate SG&A expenses to be down approximately 23% to 25% and R&D expenses to be down 25% to 27% year-over-year. At September 30, 2022, we had approximately $78 million in cash, cash equivalents and marketable securities. Our accounts receivables balance was $28 million. Our accounts receivables terms range between 10 and 68 days, while our days sales outstanding are about 46 days. We estimate that as of September 30, 2022, our distribution network maintained approximately 4 weeks of inventory. Overall, we continue to deploy our financial resources to focus on the advancement of neratinib through ongoing clinical trials and the commercialization of NERLYNX.

Thanks, Maximo. During 2020 and 2021, COVID-19 pandemic presented significant commercial challenges to Puma and presented significant barriers to commercial access for Puma’s commercial team. As these restrictions have lifted during 2022, we are seeing increased face-to-face interactions with HCPs and better access overall as well, as Jeff detailed earlier. We believe that this is contributing to the increased commercial results that we are seeing this year, and we are hopeful that this will continue to trend positively. Puma’s senior management in cooperation with the Board of Directors continues to remain focused on improving NERLYNX sales in 2022 and beyond. 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 quarter was a direct result of these expense reductions. The company remains committed to continuing to achieve these operational cash flows, and we 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 at helping these patients during their journey, and we will continue to strive to achieve that goal. This concludes today’s presentation. We will now turn the floor back to the operator for Q&A. Operator?

Thank you. [Operator Instructions] Our first question is from Ed White with H.C. Wainwright. Please proceed with your question.

Hey, this is Steve on for Ed. First question, so it looks like the timing for the FDA meeting went from the second half of ‘22 to first half of ‘23. So can you explain what the change was there?

Yes. Hi, Steve. Regarding the FDA meetings for the HER2 mutated and the EGFR mutated, we ended up getting the packages to them later than we expected. So it’s just the timing of when that’s expected.

Alright. And then – so that’s good, the live interaction went up. So do you think the live sales team is the right size?

Steve, I feel pretty good about the size of the field force right now. Certainly, as the oncology market is a very restrictive market, so we’ve seen that access slowdown from several years ago. Right this moment, we feel like we’ve got the right size, and we can cover all of our key targets across the country. With that said, if access continues to open up and improve, I will certainly work with Alan, and we will adjust the field force appropriately. But I believe right now, we’re roughly the right size and are doing a good job executing our strategy.

Alright. Thanks for taking our question.

Thank you. Our next question is from Geoff Meacham with Bank of America. Please proceed with your question.

Hey, good afternoon. This is [indiscernible] calling in for Geoff Meacham. Congrats on a good commercial quarter. So I think my first question is related to that. Could you maybe give us a little bit more color what sort of drives the good commercial quarter? Is it maybe more of the live interactions with clinicians or is it maybe COVID going back to normal? Just any color you can provide?

Yes. Thanks for the question. I appreciate it. Just at a high level, what I’ll tell you is that NERLYNX is promotionally sensitive. So being able to increase engagements and overall share of voice is very important and it certainly has an impact. As we talked about, we’ve seen improved overall access, which leads to increased productivity by our sales force. In addition, we’ve worked hard on improving our non-personal promotion as well and targeting those customers that we’re not able to reach via search, digital and social media. I would also say that our teams have done a good job of executing on our peer-to-peer strategy, and our teams have increased their engagement with local and regional advocacy organizations. And lastly, I’ll throw out that NCCN changed their guidelines at the beginning of the year. And although that’s not going to drive adoption, it certainly supports the efforts that we’re trying to accomplish. So it really helps give us some air cover as well.

Yes. And if I can add to that, I would say, if you look at all of the metrics like HCP interactions per rep, etcetera, they keep going up quarter-over-quarter, which is obviously positive. Jeff is exactly right that with COVID restrictions, there were still some cancer centers that had COVID restrictions and those have been reduced. So that has no question, helped us as well. And I think we do get a lot of feedback from the field force that the change to the NCCN guidelines, including NERLYNX has been very helpful as well. So I would imagine that that’s playing a role, too.

Okay. And just quick on the cost, so for the R&D, do you foresee any more resourcing such that now you have two molecules to develop. And then for the SG&A, for promotion, do you see the need because of live interaction, you need more resource in 2023 to better promote?

We have not changed our guidance from a spending perspective. So I would say we would not see that increase and especially on the R&D side, remember that with neratinib, we’re continuing to decrease our R&D expenses because there is less patients on the SUMMIT studies and some of the other studies like our earlier studies like CONTROL, etcetera. We’re still in the process of closing down. So those costs are coming out. So you’ve kind of got the cost from the neratinib studies going down, while the ones from alisertib. I don’t think we will see a whole lot this year, a very small amount, more next year. But again, with one going down and the other going up, it’s going to kind of flatten, I would imagine.

Okay, that’s helpful. Thank you.

Thank you. Our next question is from Gena Wang with Barclays. Please proceed with your question.

Hi, thanks for taking our question. This is Tom for Gena. Maybe first, just wondering if there are any updates on the payer split between commercial and Medicare, Medicaid? And secondly, still on the patient compliance for new starters, how many percentage do you see could stay through the first like 2 to 3 months where they get stabilized?

Sure. Let me address both of those questions. First, from a general split of payer, again, this fluctuates quarter-by-quarter. But I would say for modeling, roughly 65% is commercial. About 25% would be government, Medicare, Medicaid, VA, DoD. And we also see about the remaining 10% is either unidentified or uninsured self-pay. So that’s – hopefully that answers that. In terms of length of therapy, and I think you’re asking, given the uptake of dose escalation, let me just give you a broader perspective there. First of all, through market research and customer engagement, we know that dose escalation is well-received by the majority of physicians and their staff and that physicians that do adopt dose escalation are more likely to start additional patients on NERLYNX going forward. We also know that persistence and compliance are impacted by other things other than just dosing and side effects. But to address your specific question, dose escalation, as you know, per our label, has patients increasing dose to full dose by week 3. So thinking about that, we would expect to see the benefits of dose escalation in month 2 and month 3. Our data does fluctuate, but we’re currently seeing an absolute benefit of about 5% to 7% in decreased discontinuations or increased persistence by month 2 between the full dose and dose escalation. Dose escalation overall is really important to us strategically, and we are not only trying to improve persistence and compliance through additional adoption of dose escalation, but other ways to support patients throughout their journey. So hopefully that helps out.

Yes. Very helpful. Maybe if I could have a follow-up regarding the FDA discussion in the next year. Just wondering if you’re going to wait for the biomarker data updated from the alisertib before you have the discussion with the FDA or you will just proceed with the FDA before that?

We’re going to be proceeding with the FDA, assuming we have the biomarker data. And if we don’t have it, we will probably still proceed with them because a lot of the populations that we’re going after, for example, the c-Myc amplified or the RB1 mutated in small cell lung cancer, we already have that data. So obviously that can be used for a discussion in other tumors like breast. If we have it for the breast, we can obviously involve that as well, but it won’t stop us from having the conversations with FDA on breast or on small cell lung.

Thank you.

This concludes our question-and-answer session. I would like to turn the conference back to Mariann for any 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.