Puma Biotechnology, Inc. (PBYI) Q1 2023 Earnings Call Transcript


Good afternoon. My name is Rob, 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 Investor Relations for Puma Biotechnology. You may begin your conference.

Mariann Ohanesian

Thank you, Rob. Good afternoon and welcome to Puma’s conference call to discuss our financial results for the first quarter of 2023. Joining me on the call today are Alan Auerbach, Chief Executive Officer, President and Chairman of the Board of Puma Biotechnology; Maximo Nougues, Chief Financial Officer; and Jeff Ludwig, Chief Commercial Officer.

After market closed today, Puma issued a news release detailing first quarter 2023 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 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 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, May 4, 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

Thank you, Mariann, and thank you all for joining our call today.

Today, Puma reported total revenue for the first quarter of 2023 of $52.8 million. Total revenue includes product revenue net, which consists entirely of NERLYNX sales, as well as royalties from our sublicensees. Product revenue net was $46.8 million in the first quarter of 2023, which represents a decline as expected from $53.7 million reported in Q4 2022 and it represents a 15% increase from $40.7 million reported in Q1 of 2022.

Product revenue for the first quarter of 2023 was impacted by approximately $3.8 million of inventory drawdown at our specialty pharmacies and specialty distributors. Royalty revenue was $6 million in the first quarter of 2023 compared to $12 million in Q4 of 2022 and $5 million in Q1 of 2022.

We reported 2,849 bottles of NERLYNX sold in the first quarter of 2023 compared to 3,323 bottles sold in Q4 of 2022. As we noted on last quarter’s call, we estimate that Q4 inventory build amounted to approximately 164 bottles. In Q1 2023, new prescriptions, or NRx, were up approximately 11% compared to Q4 2022, and total prescriptions were down approximately 4% compared to Q4 2022. Jeff will provide further details in his comments and slides.

I will now provide a clinical review of the quarter, and then Jeff Ludwig will add additional color on NERLYNX commercial activities. 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, in September 2022, Puma was pleased to announce that we had 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 anticancer drugs in the treatment of various cancers, including hormone-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 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 are treated across 22 company-sponsored trials.

We are currently anticipating that we will be meeting with the FDA late in the second quarter of 2023 to discuss the registration pathway for alisertib in small cell lung cancer and with substantially — subsequently anticipate initiating clinical trials of alisertib in small cell lung cancer in the fourth quarter of 2023.

In March, we are pleased to announce the publication of clinical trial results from TBCRC-041 in JAMA Oncology. This was a randomized trial that tested alisertib monotherapy versus alisertib plus fulvestrant in patients with hormone receptor positive HER2-negative breast cancer. We are pleased to see the activity of alisertib in this patient population, as well as a resulting biomarker analysis in the publication.

As investors are also aware, in April 2021, data was published in JAMA Network Open from a randomized Phase 2 trial of paclitaxel plus alisertib versus paclitaxel in patients with metastatic breast cancer. In patients with hormone receptor positive HER2-negative breast cancer, the data showed a statistically significant benefit in progression-free survival for patients who received alisertib plus paclitaxel compared to patients who received paclitaxel alone. We anticipate that the biomarker data from this trial will be presented as a poster at the American Society of Clinical Oncology or ASCO Annual Meeting in June. 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 previously mentioned biomarker data from the randomized trial of alisertib plus paclitaxel versus paclitaxel alone in home receptor positive HER2-negative breast cancer, which, as I mentioned, will be presented at ASCO in June.

Also, data from an ongoing investigator-sponsored Phase 1/2 trial of alisertib plus pembrolizumab in the treatment of patients with RV deficient head and neck squamous cell cancer, which is anticipated sometime in 2023, conducting a meeting with the FDA to discuss the registration pathway for alisertib in small cell lung cancer, which we anticipate in late Q2 of 2023 and conducting the meeting with the FDA to discuss the registration pathway for alisertib and home receptor positive HER2-negative breast cancer, which we anticipate 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 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.

Jeff Ludwig

Thanks, Alan. Appreciate it, and thanks to everyone for joining our first quarter earnings call.

Before I move into the commercial review, just a reminder that I will be making forward-looking statements. Our commercial strategy continues to be largely focused on the extended adjuvant indication with the goal of helping more patients reduce their risk of reoccurrence. Although progress continues to be made, this market is underpenetrated and more needs to be done to support patients in their battle with HER2-positive breast cancer. Our commercial team is focused on increasing our reach and frequency to HCPs via personal and nonpersonal promotion as well as extending our outreach to better educate patients around the risk of reoccurrence and the risk-benefit profile of NERLYNX. Our goal is to increase penetration in the extended adjuvant setting and drive consistent growth.

Specifically in regards to Q1, I am pleased that we saw HCP calls increase approximately 16% quarter-over-quarter. And of those calls, about 81% were live versus virtual. Also in Q1, our marketing team evaluated our nonpersonal promotion strategy and worked to refine and relaunch some of these tactics with the goal of increasing impact in Q2 and beyond.

Lastly, the commercial team led by our clinical nurse educators continue to focus on expanding our outreach to local and regional advocacy organizations. With that very high-level update, let me transition to some of the U.S. commercial slides where I will provide some additional specifics around the business. Once I’m finished, I’ll turn the call over to Maximo for a more detailed review of our financial results.

Now moving to Slide 3. Our distribution model has not changed and remains separated into two distinct 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, but we did see some stronger Q1 performance in the SD channel. So the overall split did change slightly from Q4. In Q1, approximately 75% of our business went through the specialty pharmacy channel, with the remaining 25% of the business going through the specialty distributor channel. As a reminder, in Q4, we reported that 78% of our business went through the specialty pharmacy channel and the remaining 22% went through the SD channel.

Now 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 $46.8 million in the first quarter of 2023. This is a $6.1 million increase from Q1 of 2022 and a $6.9 million decrease from Q4 of 2022. Inventory changes clearly have an impact on these numbers, so let me give you some additional insight.

In Q1, we estimate that inventory decreased by about $3.8 million. As a comparator, we estimate that inventory decreased by about $4.3 million in Q1 of 2022 and increased by about $2.6 million in Q4 of 2022.

Moving to Slide 5. Slide 5 shows 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 2,849 bites of NERLYNX in Q1 of 2023, which is about 6% higher compared to Q1 of 2022 and about 14% lower than Q4 of 2022.

Now again, let me provide a little more insight around inventory changes here. We estimate that inventory decreased by about 236 models in the first quarter of 2023. As a comparison, we estimate that inventory decreased by about 282 bottles in Q1 of 2022, and increased by about 164 bottles in Q4 of 2022.

Now the commercial team is focused on execution with the goal of driving growth both quarter-over-quarter and year-over-year. Given this priority, let me provide some more specifics around a few key metrics. In Q1, we saw quarter-over-quarter growth in enrollments of about 2.5%, but a decline of about 10% year-over-year. In regards to commercial new patient starts or NRx, we saw an 11% growth quarter-over-quarter and a 1% growth year-over-year. Lastly, turning to demand. In Q1, we saw quarter-over-quarter demand decreased by about 2.3% but increased by about 4% year-over-year, driven by strong growth in the SD channel.

Slide 6 highlights the adoption of dose escalation. We continue to believe that dose escalation is an important metric as it serves to improve the tolerability of NERLYNX by significantly reducing Grade 3 diarrhea, decreasing discontinuation rates and reducing the median days of Grade 3 diarrhea. In Q1, approximately 64% of patients who received commercial drug started NERLYNX on a lower daily dose, which is similar to what we reported in Q4 of 2022.

I’m overall happy with the adoption of dose escalation and pleased to see dose escalation included in many prominent guidelines, including NCCN. We do have some physicians that are comfortable starting on full dose in the extended adjuvant setting and some that prefer to start at full dose in the metastatic setting. With that said, the commercial team continues to discuss and educate around the benefits of dose escalation.

Slide 7 highlights the collaborations we have formed across the globe. In Q1 of 2023, NERLYNX received regulatory approval in the extended adjuvant setting in both Morocco and South Africa and received regulatory approval in the metastatic setting in Colombia. Also in Q1 2023, we are happy to announce that NERLYNX was officially launched in Mexico in the extended adjuvant setting. Our global partners continue to focus on driving increased adoption and preparing for future launches. I look forward to highlighting their continued progress moving forward.

I want to thank my commercial colleagues for their continued dedication to becoming more efficient and more effective as we strive to make a bigger impact on patients battling breast cancer. I also want to thank the broader Puma organization for their support and partnership. I know they also share a passion for making a broader impact on patients.

I’m now going to turn the call over to Maximo for a full review of our financial results.

Maximo Nougues

Thanks, Jeff.

I will begin with a brief summary of our financial results for the first quarter of 2023. Please note that I will make comparisons to Q4 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 Q1 2023 10-Q, which will be filed today and includes our consolidated financial statements.

The first quarter of 2023, we reported net income based on GAAP of $1.4 million or $0.03 per share. This compares to a net loss in Q4 2022 of $5.6 million or $0.12 per share. On a non-GAAP basis, which is adjusted to remove the impact of stock-based compensation expense, we reported net income of $4.2 million or $0.09 per share for the first quarter of 2023.

Gross revenue from NERLYNX sales was $59.4 million in Q1 2023 and $65.4 million in Q4 2022. As Alan mentioned, net product revenue from NERLYNX sales was $46.8 million compared to the $53.7 million reported in Q4 2022. We believe that Q1 net sales were impacted by approximately $3.8 million of inventory drawdown from our distributors. Royalty revenue totaled $6 million in the first quarter of 2023 compared to $12 million in Q4 2022. The lower royalties versus Q4 reflects the timing of shipments to our partner in China.

Our gross to net adjustment in Q1 2023 was about 21.2% compared to the 17.8% gross to net adjustment reported in Q4 2022. Higher co-pay was the main driver of the increase versus Q4 2022. Cost of sales for Q1 2023 was $13.2 million, including $2.4 million for the amortization of intangible assets related to our neratinib license. Cost of sales for Q4 2022 was $16.8 million. Going forward, we will continue to recognize amortization of milestones to the licensor of about $2.4 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 the 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.

We anticipate that for Q2 2023, NERLYNX net sales will be in the range of $47 million to $50 million. Also, we expect Q2 royalties revenue will be in the range of $2 million to $3 million. We further estimate that the gross net adjustment in Q2 2023 will be approximately 20% to 21%. Puma anticipates a Q2 net profit of between $0 million and $1.5 million.

SG&A expenses were $22.5 million in the third quarter of 2023 compared to $25.1 million for the fourth quarter. SG&A expenses included noncash charges for stock-based compensation of $2 million for Q1 2023 compared to $1.8 million for Q4.

Research and development expenses were $12.7 million in the first quarter of 2023 compared to $13.8 million for the fourth quarter. R&D expenses included noncash charges for stock-based compensation of $0.9 million in the first quarter of 2023, unchanged from the fourth quarter.

In the first quarter of 2023, Puma reported cash burn of approximately $9.9 million compared to cash earned of approximately $3.1 million in Q4 2022. In Q1 2023, we made a $12.5 million payment to Pfizer related to the achievement of our global revenue milestone and $8 million payment related to a legal settlement.

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.

On March 31, 2023, we had approximately $71 million in cash, cash equivalents and marketable securities. Our accounts receivables balance was $31.2 million. Our accounts receivable terms range between 10 and 68 days, while our days sales outstandings are about 48 days. We estimate that as March 31, 2023, our distribution network maintain approximately three 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.

Alan Auerbach

Thanks, Maximo. We are pleased to be able to achieve positive net income during the first quarter of 2023. 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 net income reported in the first 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 full year 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 at Puma are committed and passionate about finding more effective ways and helping these patients during their journey, and we’ll 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?

Question-and-Answer Session


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

Ed White

Sorry. Good afternoon. Thanks for taking my questions. So the first question is just a clarification. What was the gross to net in the quarter? Did I hear 22 point something?

Maximo Nougues

Give me a second, no the gross to net was $21.2 million.

Ed White

$21.2 million, great thank you. And are you seeing an increase in your patient assistance programs increase in participation?

Alan Auerbach

So Ed, in terms of patient assistance programs, are you talking about free drug or are you talking about additional support for mentorship and things of that nature?

Ed White

No, free drug.

Alan Auerbach

It’s free drug in Q4, we did not see an increase in that. We’ve actually been watching that very closely. We had a trend going for partial last year where we’re seeing an increase in noncommercial drug that did not hold true in Q1.

Ed White

Okay. Great. Thanks. And just regarding the royalties can you give us – you provide maybe a little bit of clarity on the growth projections. I know China has always been lumpy for you, but with the sort of end of COVID over there – should we see a little bit more, smooth this year? And also, what are your partners doing outside the U.S. to sort of boost the sales numbers?

Alan Auerbach

Yes. Ed to answer the question, in terms of the lumpiness of China, you’re absolutely correct. It is lumpy. We do get payments of various amounts. A lot of that is also because of the fact that we manufacture the drug for our partners and then sell it to them and then they sell it to the market. And with China specifically, a lot of that lumpiness has been that manufacturing of it as well. So and when we can transfer things over and the time it takes and things like that.

So that kind of contributes to that lumpiness. To answer your second question in terms of what our ex U.S. partners are doing, in every country, it’s different. And a lot of them, they are situations where there’s countries that we still haven’t gotten reimbursement for us. So we’re waiting for that, and that will provide some additional boost. But in all of them, we continue to see them doing the same thing we’re doing in the U.S., which is trying to increase their share of voice and having more interactions with the physicians.

Ed White

And are they also running the programs like you did to – in an effort to increase the number of patients that start on the lower dose?

Alan Auerbach

And in some countries, we do have lower dose approved in others, it’s not yet on the label. So I think there’s, educational efforts around appropriate dosing to try to reduce any of the side effects. In some countries, we do have that as a promotional portion of the other mix and others it’s not there yet, from a label perspective.

Ed White

Okay. Thanks. And my last question is just on the subject of starts at the lower dose. It seems the first quarter was down from the first quarter of last year. Are you sort of at a plateau right now do you think this is the level that patients will be at or is there something that you can do to increase that lower dose start?

Alan Auerbach

Yes. Great question. I appreciate it. And obviously, as I keep saying, we think that’s very important that we continue to drive the low dose as it does change that tolerability profile. I’m going to give you an estimate. And I would guess that we have still some room to further penetrate, but we’re not too far off of the max that we’re going to see, and I’ll explain that a little bit more. There’s, a couple of factors going on here.

Number one, as I mentioned, there are some folks in the metastatic setting, which is a small part of our business, but there are clinicians – in the metastatic setting that want to start on full dose for just efficacy reasons into metastatic, that urgency to treat. We also have several clinicians or a group of physicians in the extended adjuvant that are very comfortable starting on a full dose.

And if a patient has challenges with side effects and/or diarrhea, they want to dose reduce as opposed to going the other direction. But the vast majority are starting on low dose and moving up. The one other piece that I think is important, I want to make sure I articulate that again is, as you saw in my opening that about 25% of our business now goes through the SD channel. So we’ve seen some growth in the in-office dispensing channel.

The reason that’s important in this context is that if a patient starts in the SD channel and stays in the SD channel, we won’t know what their dosing is. We do not get patient-specific information. We also won’t get an enrollment from those patients. They don’t come over to the SP side where we collect enrollments. What is not uncommon is that a patient will start in the SD portion, the adoption of dose escalation, we believe, in the community setting is pretty strong.

If they start in the SD session portion of our business on a low dose and because the payer forces them to move to a specialty pharmacy after the first or second fill, that specialty pharmacy prescription will start at 180, right? They will be on their second or third fill and come in at full dose. And so — and we don’t capture that as clearly as we would like. So the numbers I quote to you are understated from what we believe the actual execution of low dose is. Hopefully, that makes some sense.

Ed White

It does. Thanks a lot for the clarity.


The next question comes from the line of Divya Rao with TD Cowen. Please proceed with your question.

Divya Rao

Hi. Divya on for Mark. Thanks for taking our question. To follow up on the gross net question it looks like for the full year to keep in line with the guidance. The second half gross net used to be around 18%. I guess what do you think – what are the kind of assumptions you’re making that would lead to a significant decrease in that gross net. And then I have a follow-up to that?

Maximo Nougues

Yes. So in terms of gross net, you’re right, that’s about what we expect for the back half. What we’re seeing is some of the inflation data, right, that is offsetting some of the price increases that we had. So other than that, we really don’t plan for any significant changes. Again, you need to remember that Q1 is usually the highest quarter in terms of gross net due to co-pay and [inaudible] and so on.

Divya Rao

That’s helpful. And then switching gears to the alisertib program. I realize that you guys haven’t had a conversation with the FDA yet. But I guess, internally, do you guys expect to run a randomized trial or do you think you could potentially go forward with a single-arm trial? And then, are there any kind of design criteria that you think the FDA would require that maybe you guys would reconsider moving forward with alisertib in small cell lung cancer?

Alan Auerbach

Divya just so I understand the – your last part, can you repeat that question and clarify a little bit?

Divya Rao

Yes. I was just asking if there was any design criteria that maybe the FDA might require for you to run in a trial that you move forward and just based on either cash constraints or anything like that you guys might reconsider or conservation of capital that might reconsider moving?

Alan Auerbach

Yes. Yes. Okay. Okay. So first of all, in terms of your – the first part of your question, which is alisertib, do we think the path to market is a single-arm trial, which would allow for an accelerated approval or a randomized trial or a combination of both. That’s the reason for having the meeting with the FDA. Now looking at small cell lung cancer, for example, on one sort of the ledger, you have that there is a regulatory history of them approving drugs based on single-arm trials in that indication. So you do have a regulatory precedent there.

On the other side of the ledger, you obviously have the recent guidance that’s come out from the FDA, which has been leaning more toward randomized trials and away from single-arm trials. That’s the reason for having the discussion with them. So whether it’s a monotherapy trial, whether it’s a — single on trial, I should say, or randomized. That’s what we want to discuss with them, whether it’s in the entire small cell lung cancer population or one that’s a biomarker-focused is another discussion we want to have with them.

To your last question, which is, is there any design that due to cash reasons we would not take forward. As we have said in every one of our earnings calls, the most important thing for this company is to make sure that we are net income positive and cash flow positive. So I think at your guys’ conference, Mark had asked me the question as well, which was would you stagger the indications to be able to conserve cash and protect that net income line?

Absolutely, if it need be and we need to stagger the breast and the lung indications, such that we can continue to be net income positive and cash flow positive, there’s no question we will do that. Like I said, in every one of our earnings calls, we have said the most important thing for this company is to continue to be net income positive and cash flow positive, and we will manage our R&D budget in order to achieve that.

Divya Rao

Got it, that’s very helpful. Thank you.


Our next question comes from the line of Geoff Meacham with Bank of America. Please proceed with your question.

Unidentified Analyst

This is Hao on for Geoff Meacham. Thank you for the question. And so just the question on the 2Q net product guidance, it seems to be indicated a decline year-over-year, while your Q1 was pretty strong in terms of new patient growth quarter-by-quarter and year-by-year in terms of net product revenue. So I just wanted to understand a little bit more on the assumptions going into that 2Q guidance there?

Alan Auerbach

I’m sorry, can you repeat your question one more time, please?

Unidentified Analyst

Yes. So my question is about the 2Q second quarter net product revenue guidance of $47 million to $50 million seems to be a year-over-year decline, while you had a pretty strong 1Q in terms of revenue growth year-over-year. New patient enrollment was also 11% quarter-by-quarter growth. So just wanted to understand the assumption goes into that 2Q net product revenue guide?

Alan Auerbach

Yes. Okay. So thank you for clarifying that. Comparing Q2 2023 to Q2 2022, you have to remember that there was an inventory build in Q2 of 2022 of roughly 150 to 200 bottles. So that’s going to offset that revenue comparison that you’re doing.

Unidentified Analyst

Awesome that’s helpful. Thank you.


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

Unidentified Analyst

Hi. Good evening. Thank you for taking our question. This is Harshita on for Gena. Perhaps a big picture question for you, Alan so for neratinib last quarter, you announced discontinuation of the SUMMIT study. So what should our focus be on neratinib in terms of growth opportunities outside of already approved indications going forward or is the thinking now primarily on alisertib in terms of expansion opportunities while neratinib revenue provides floor value [ph]?

And on the heels of that, if you could expand a little more on opportunities you’re exploring to like in-license other products like how are you thinking about it? Is it primarily in cancer that would complement your pipeline? Any additional color on that would be helpful? Thank you

Alan Auerbach

Yes. Thank you for the question. So with regard to NERLYNX neratinib, you’re correct that we decided not to take the SUMMIT indications forward. And the main reason for that is that our competition matter patent on neratinib expires in December 2030. So for us to go do randomized trials in these very rare mutations where you screen the patients, which can add additional time and cost, the ROI just wasn’t positive to do that and again, for us to go run five-year trials or something, by the time in which you’re approved through 2028 or 2029.

You’re just not going to get the return on investment for that. And again, it’s very important for us to protect the investors and protect their ROI. So you’re correct that we chose not to take that forward. And for neratinib, the main growth will be continued execution in both the extended adjuvant and the metastatic breast cancer settings. Obviously, for alisertib, we have the two indications to go forward with, which is small cell lung cancer and HR-positive HER2-negative metastatic breast cancer.

And then we are continuing to look at other assets in license. First of all, as I mentioned to the prior question, the most important thing to us is continuing to maintain the company at net income positive and cash flow positive. So we obviously would look to bring anything else in and again, with a protection of those 2 things, net income positive and cash flow positive. Cancer is what we know. It’s what our domain knowledge is.

Would we look outside of that? I don’t think so. We just don’t possess the skill set to be able to do the right assessment of it and to develop it and commercialize it. It wouldn’t — right now, we have an existing commercial infrastructure in oncology specifically. It doesn’t really go outside of oncology.

I realize there’s some cancers, for instance, like prostate or something where you go into urology and it’s a different field and things like that. You don’t really have that with breast cancer. It’s just strictly an oncology setting. So what would make the most sense from a complement perspective is something in the oncology space. We really wouldn’t look outside that…


Thank you. Our final question is from the line of Mayank Mamtani with B. Riley Securities. Please proceed with your question.

Unidentified Analyst

Hi. Yes. Congratulations again and thanks for taking our questions. This is actually William on for Mayank. So I realize the financials have been picked over a little bit. So I was actually curious about a couple of your trials with data reporting later this year. Just curious – if we could get a little bit more color on the biomarker data that we should be expecting upcoming in your HER2-negative breast cancer and then potentially also. And then where we might be expecting that and then sort of the same idea behind the investigator-sponsored Phase I/II trial also coming up this year? Thanks.

Alan Auerbach

Thank you for the question. So alisertib was previously tested in a trial in breast cancer, and it was both HR-positive, HER2-negative breast cancer and triple-negative breast cancer. In the patients with — and it showed efficacy in both, specifically in the patients in HER2-negative HR-positive breast cancer. It was a trial of paclitaxel plus alisertib against paclitaxel alone. And the trial showed a progression-free survival benefits.

They’re doing a biomarker analysis on that, and that will be presented as a poster at the ASCO Annual Meeting in June. More specifically, what we’re interested in looking at is with an aurora kinase inhibitor like alisertib, there’s a lot of pathways that one would anticipate could be inhibited by an aurora kinase inhibitor. So for example, in our small cell lung cancer trial that was published, there was biomarker data showing greater efficacy in the patients with CMIC amplifications or with RB1 mutations or RB1 deletions.

So that is what we’d be very interested in seeing would be anything that would suggest to us that by enriching the population with a certain biomarker where we think alisertib would be more active, you would get a much greater magnitude of the benefits, which obviously would be better from an R&D perspective, but obviously potentially a commercial one as well. So that’s really the data we would be looking for from that trial.

On your second question, that trial, which is the pembrolizumab plus alisertib in RB1 deficient head and neck cancer is still enrolling. My assumption would be that we would present that probably second half of this year sometime. I don’t think we’ve chosen the conference yet for that. So once we do, we will definitely let investors know.

Unidentified Analyst

Awesome — really appreciate that, and thanks again.


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

Mariann Ohanesian

Thank you all for joining us today. As a reminder, this call may be accessed via replay of the webcast at 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.