Puma Biotechnology, Inc. (PBYI) CEO Alan Auerbach On Q4 2021 Results - Earnings Call Transcript

Mar. 03, 2022 7:08 PM ETPuma Biotechnology, Inc. (PBYI)
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Puma Biotechnology, Inc. (NASDAQ:PBYI) Q4 2021 Earnings Conference Call March 3, 2022 4:30 PM ET

Company Participants

Mariann Ohanesian - Senior Director, IR

Alan Auerbach - Chairman, President & CEO

Jeff Ludwig - Chief Commercial Officer

Maximo Nougues - CFO

Conference Call Participants

Edward White - H.C. Wainwright

Carly Kenselaar - Citi

Marc Frahm - Cowen

Alex Hammond - Bank of America

Disclaimer*: This transcript is designed to be used alongside the freely available audio recording on this page. Timestamps within the transcript are designed to help you navigate the audio should the corresponding text be unclear. The machine-assisted output provided is partly edited and is designed as a guide.


00:04 Good afternoon, my name is Alexandra, and I will be your conference call operator today. At this time, all participants are in a listen-only mode. After the speakers' formal remarks, there will be a question-and-answer session. [Operator Instructions] As a reminder, this call is being recorded.

00:38 I would now like to turn the conference call over to Mariann Ohanesian, Senior Director of IR for Puma Biotechnology. You may begin your conference.

Mariann Ohanesian

00:47 Thank you, Alex. Good afternoon, and welcome to Puma's conference call to discuss our financial results for the fourth quarter of 2021. 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.

01:09 After market closed today, Puma issued a news release detailing fourth quarter 2021 financial results. That news release, the slides that Jeff will refer to and a webcast of this call are accessible via the home page 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.

01:37 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.

01:57 For a full discussion of these risks and uncertainties, please review our periodic and current reports filed with the Securities and Exchange Commission from time-to-time, including our annual report on Form 10-K for the year ended December 31, 2021. 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 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.

02:36 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 2021 news release for a reconciliation of our GAAP to non-GAAP results.

03:00 I will now turn the call over to Alan.

Alan Auerbach

03:03 Thank you, Mariann and thank you all for joining our call today. Today Puma reported total revenue for the fourth quarter of 2021, a $55.4 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 $51 million in the fourth quarter of 2021, which represents increases from the $43.4 million in product revenue net reported in the third quarter of 2021 and $50 million in product revenue net reported in Q4 of 2020.

03:45 Product revenue for the fourth quarter included approximately $5 million of inventory build at our specialty pharmacies and specialty distributors. Royalty revenue was $2.9 million in the fourth quarter of 2021 versus $2.8 million in Q3 2021 and $2.6 million in Q4 2020. License revenue was $1.5 million in Q4 2021. We reported 3,454 bottles of NERLYNX sold in the fourth quarter of 2021, an increase from the 2,947 bottles sold in Q3 2021.

04:23 Bottles sold in the quarter included an estimated 345 bottles, representing inventory stocking at our specialty pharmacies and specialty distributors as mentioned earlier. New prescriptions were down 8% in Q4, compared to Q3, while total prescriptions were down 2.8%. Bottles sold through our specialty distributor network which we often refer to as our in-office network were up 2.6% in Q4, compared to Q3. Jeff will provide further details in his comments and slides.

04:55 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 follow with highlights of the key components of our financial statements for the fourth quarter of 2021. As we have mentioned on prior calls, Puma has an ongoing basket trial of neratinib in HER2 mutated cancers, referred to as the SUMMIT trial. In the fourth quarter of 2021, Puma met with the FDA to discuss the regulatory path for neratinib in patients with hormone receptor positive HER2-negative breast cancer, who have a HER2 mutation. Investors will remember that based on a meeting with the FDA in the fourth quarter of 2019, this arm on the SUMMIT trial was modified such the patients were randomized to receive either fulvestrant alone, fulvestrant plus trastuzumab, or the combination of neratinib plus fulvestrant plus trastuzumab.

05:52 Under the initial Simon 2-stage design, each of the three arms enrolled seven patients during stage 1 and if no patient in a given arm responded that arm was closed to further enrollment. If in the first stage one or more patients responded the arm was then expanded up to 18 patients. If less than four patients in the expanded arm respond that arm was close to further enrollment. If more than four patients responded the arm was expanded to 30 patients.

06:19 As was previously disclosed to investors and was presented at San Antonio Breast Cancer Symposium in 2021 for the first seven patients, who were treated in the fulvestrant alone arm of the trial, no patients achieved a response. In the first seven patients, who were treated in the fulvestrant plus trastuzumab arm of the trial no patients achieved the response. In the first seven patients who were treated in the neratinib plus fulvestrant plus trastuzumab arm of the trial, one or more responses were seen and therefore the criteria is met to expand to stage 2 of the Simon 2-stage design. That arm of the trial was expanded to further enrollment an additional 18 patients have been treated with the combination of neratinib plus fulvestrant plus trastuzumab. Enrollment to this arm has been stopped while we analyze the additional data.

07:09 At the meeting with the FDA in the fourth quarter of 2021, the data from the seven patients randomized to each of the three arms who shared with the FDA. Puma also notified the FDA that they had enrolled an additional 18 patients, who have been treated with the combination of neratinib plus fulvestrant plus trastuzumab and if the data from these 18 patients could be shared with the FDA in 2022. Puma plans to submit this data in the first half of 2022 and schedule a meeting to discuss the regulatory path for neratinib in this indication. Puma anticipates that the FDA will either allow the company to file for accelerated approval based on single-arm data or may require additional data or it may require a separate randomized trial for this indication. If a randomized trial is required, the company will make a decision whether or not to proceed based on the time and cost of the trial versus the potential market opportunity.

08:04 Additional data from this cohort will be presented in the first half of 2022. Puma will continue to update investors on the status of this as it progresses. As investors are also aware in November 2020, we announced interim results from another cohort of the SUMMIT trial and more specifically the cohort of patients with metastatic non-small cell lung cancer with epidermal growth factor or EGFR, exon 18 mutations who have previously been treated with EGFR tyrosine kinase inhibitor. As we've shown in the data that was presented there were full responses out of 11 patients and therefore the criteria have been met to proceed to stage-2 of the Simon 2-stage design and enroll 30 patients. There are currently 31 patients enrolled in this arm of the trial and we anticipate that we will have additional data from this cohort to report in the second half of 2022.

08:55 Once we receive this data, we plan to meet with the FDA to discuss the regulatory path for this indication. Puma anticipates that the FDA will either allow the company to file for accelerated approval based on single-arm data or may require additional data or a separate randomized trial for this indication. If a randomized trial is required, the company will make a decision whether or not to proceed based on the time and cost of the trial versus the potential market opportunity. Enrollment to this arm of the trial has been halted while we analyze the current data and wait for regulatory guidance.

09:28 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

09:36 Hey, thanks, Alan. Appreciate it and thanks to everyone for joining our fourth quarter earnings call. Before, I move into the commercial review, just a reminder that I will be making forward-looking statements. Commercially, we remain focused on three areas: number one, leveraging the evolving positive clinical data for NERLYNX; two, engaging and educating patients to ask for NERLYNX; and three, increasing our impact to field force execution and evolution. It is great to see progress being made to help support women battling breast cancer overall, but this market clearly remains under penetrated and more must be done and we clearly believe that NERLYNX can play a bigger role in helping patients throughout their journey.

10:21 We were happy to announce in Q4 that NERLYNX was included in two important NCCN Clinical Practice Guideline Updates for the treatment of breast cancer. The first update added NERLYNX to the body of the guidelines for the treatment of adjuvant HER2 positive breast cancer under the heading useful in certain circumstances. Previously NERLYNX was included as a footnote only. The updated guidelines recommends considering extended adjuvant neratinib for patients with HR positive, HER-2 positive disease with a perceived high risk of reoccurrence.

10:51 The second update involved inclusion of dose escalation as an approach to improve the tolerability of neratinib in the treatment of adjuvant HER-2 positive breast cancer. These NCCN updates are important as many institutions practices and clinicians’ references guidelines in the treatment decisions. As highlighted on our Q3 earnings call, we implemented some important organizational changes in Q4. These changes were implemented based on the evolving oncology marketplace and were designed to streamline our commercial organization, not only to better align our financial resources, but as importantly to simplify reporting structures, reduce layers of management and improve overall ownership and execution at the customer level.

11:36 We revised targeting to help our teams better focus our efforts and started building out a core strategic accounts team to better align with our largest customers. Although it's still early, I'm happy with the overall transition and the new organizational structure. I believe we are in a better position to adapt to the evolving marketplace and focus our efforts where they matter most. With that high-level update, let me transition to some of the U.S. commercial slides, and I will provide some additional insights along the way. Once I finish my remarks, I will turn the call over to Maximo who will review the full financial results.

12:11 On 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. The majority of our business continues to flow through the specialty pharmacy channel more specifically in Q4 approximately 76% of our business went through this channel, with the remaining 24% of the business flowing through the specialty distributor channel. This is in line with what we reported in the Q3 earnings call as well.

12:43 Slide 4 shows U.S. quarterly net sales of NERLYNX since FDA approval. As Alan noted, our net product sales were $51 million in the fourth quarter of 2021. This is an increase from the $43.4 million we reported in Q3 of 2021. We have consistently seen increases in inventory in the fourth quarter of each year since launch and we estimate that approximately $5 million of the fourth quarter net revenue is attributed to that increase in inventory.

13:13 Slide 5 shows the bottles of NERLYNX sold by quarter since launch. Please note, this slide shows ex-factory bottles sold, so it represents sales in your specialty pharmacy and specialty distribution channel and not end-user demand. We sold 3,454 bottles of NERLYNX in Q4 of 2021, which is an increase of 507 bottles from our Q3 2021 bottle sales of 2,947. We estimate that about 345 bottles are attributed to the increase in inventory that occurred in Q4.

13:50 Let me provide some additional insight into the business. New prescriptions and new patient starts are an important leading indicator for our business. These new patient starts turning to refills, which will influence subsequent quarters in terms of total bottles sold. As we have previously discussed, we tend to see a decline in new patient starts in the fourth quarter with the subsequent increase in the first quarter of the following year. This is driven largely by some patients deciding to delay starting on therapy until after the holidays.

14:21 As Alan mentioned, we did see a decline in new patient starts represented by NRx by about 8% in Q4, compared to Q3. This is a smaller decline that we have seen in the last several years, but nonetheless still a decline. The positive change is that year-over-year fourth quarter new patient starts are flat. In addition, we paid close attention to enrollments, which is another important leading indicator. Enrollments really represent the intention to prescribe and there is a strong correlation between enrollments and subsequent new patient starts.

14:54 Similar to new patient starts, we have historically seen a drop in Q4 enrollments with the subsequent increase in Q1. This year, we did not see a decline in Q4 enrollments, as they were flat to Q3 and were 2% higher than Q4 of last year. We do continue to see an increase in the number of patients qualifying for free drug through our patient assistance program, which is being driven largely by the limited availability of co-pay support from the foundations. This is contributing to the decline in NRx compared to enrollments being flat.

15:28 As previously reported, we were excited to have dose escalation added to our label in late June for both our extended adjuvant indication, as well as our metastatic indication. In addition, again, we are pleased that NCCN updated their Clinical Practice Guidelines for breast cancer to include dose escalation in early stage breast cancer.

15:46 As you can see, we saw an increase in the adoption of dose escalation in the fourth quarter were over 60% of patients were started on NERLYNX at a lower dose. We are pleased with the increasing adoption of dose escalation and believe that this increased adoption will improve the overall tolerability of NERLYNX, increased the average length of therapy and ultimately allow more patients to receive the full benefit of NERLYNX.

16:11 Slide 7 highlights the strategic collaborations we have formed across the globe with the goal of making NERLYNX available to more patients around the world. We continue to be pleased with our global partners with the progress being made. As mentioned on the Q3 earnings call, we were pleased that NERLYNX received extended adjuvant approval in South Korea, metastatic regulatory approval in Taiwan and it was officially launched in Peru, all in early Q4.

16:38 Additional recent highlights include regulatory approval in Chile in the metastatic setting, regulatory approval in both Brazil and Mexico in the extended adjuvant setting an official launch in South Korea. On top of that we are extremely pleased that in December of 2021, we were notified by our partner Pierre Fabre that NERLYNX was added to China's National Reimbursement Drug List or NRDL for 2022. NRDL approval is an important milestone and will significantly increase access to women battling early stage breast cancer in China. We are continuing to work closely with the partners and look forward to future potential launches in additional countries in Europe, Latin America, Asia and the Middle East.

17:24 Now Puma was founded on a commitment to making a difference in the lives of patients and their families battling breast cancer. I want to thank the commercial team for their passion and commitment to making such a difference. We know more must be done and we will not stop until we have achieved our goals.

17:39 I’m now going to turn the call over to Maximo for a review of our financial results. Maximo?

Maximo Nougues

17:47 Thanks, Jeff. I will begin with a brief summary of our financial results for the fourth quarter of 2021. Please note that I will make comparisons to Q3 2021, which we believe it's a better indication of our progress as a commercial company and year-over-year comparisons. For more information I recommend that you refer to our 2021 10-K which we will be filed today and includes our Consolidated Financial Statements.

18:17 For the fourth quarter of 2021, we reported net income based on GAAP of $4.2 million or $0.10 per basic and diluted share. This compares to our Q3 2021 net loss of $44.7 million or $1.09 per share. On a non-GAAP basis, which is adjusted to remove the impact of stock-based compensation expense, we reported net income of $8.4 million or $0.21 per basic and diluted share for the fourth quarter of 2021.

18:56 Gross revenue from NERLYNX sales was $64.5 million in Q4 2021 versus $53.8 million in Q3 21. Alan mentioned it, net product revenue from NERLYNX sales was $51 million compared to the $43.4 million we reported in the third quarter of 2021. We believe that Q4 net sales included approximately $5 million of inventory buying from our distributors. Royalty revenue totaled $2.9 million in the fourth quarter of 2021 versus $2.8 million in Q3 2021.

19:38 Our gross net adjustment in Q4 2021 was about 21%, an increase from the 19.4% gross to net adjustment in Q3 2021. The increase was driven mainly by higher Medicaid rebate, higher co-pay and higher interest participation in government pricing. Cost of sales for Q4 2021 was $11.9 million including $2 million for the amortization of intangible assets related to our neratinib license. Cost of sales for Q3 2021 was $10.3 million. Going forward, we will continue to recognize amortization of milestones to the licensor for about $2 million per quarter as cost of sales.

20:32 For fiscal year 2022, Puma anticipates the net product revenue will be in the range of $180 million to $190 million. We also anticipate that our gross to net adjustment for the full-year 2022 will be between 21.5% and 22.5%. Furthermore, for the fiscal year 2022, we anticipate receiving royalties from our partners around the world in the range of $27 million to $34 million and license revenue in the range of 0 to $1.5 million. We recognize it 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.

21:27 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 of our bottles sold in Q1, as well as higher gross to net due to higher co-pay and coverage gaps expenses that typically occur in the first quarter. We also are anticipating that Q1 revenues will be impacted by the higher amount of free drug needed to be administered due to the decline in funding for the Medicare foundations that Jeff mentioned it in his remarks.

22:12 We anticipate that Q1 2022 NERLYNX net sales will be in the range of $35 million to $39 million, I may repeat that $35 million to $39 million. This guidance assumes that $5 million of the inventory buying from Q4 is worth doing the quarter. We also anticipate Q1 royalty revenues will be in the range of $5 million to $7 million. We anticipate that gross to net adjustment in Q1 2022 will be approximately 23% to 24%.

22:54 SG&A expenses were $22.5 million in the fourth quarter of 2021 compared to $26.1 million from Q3 2021. SG&A expenses included non-cash charges for the stock-based compensation of $2.4 million for the fourth quarter of 2021 compared to $3 million for Q3 2021. Research and development expenses were $14.2 million in the fourth quarter of 2021 compared to $18.8 million for Q3 2021. R&D expenses included non-cash charges for stock-based compensation of $1.8 million in the fourth quarter compared to $1.3 million for Q3 2021.

23:42 In the fourth quarter 2021, Puma reported cash burn of $5.4 million compared to cash burn of $21.4 million in Q3 2021. The cash burn for the full year 2021 was $11.3 million. As a result of the cost containment actions across the company implemented in the fourth quarter of 2021, Puma is expecting lower operating expenses in 2022 compared to 2021. More specifically, we anticipate SG&A expenses to be down approximately 15% to 20% and R&D expenses to be down 10% to 15% year-over-year.

24:28 At December 31, 2021, we had $82.1 million in cash, cash equivalents and marketable securities. Our accounts receivables balance at the end -- at year end was $32.5 million. Our accounts receivable terms range between 10 and 68 days, while our days sales outstandings are about 48 days. We estimate that as of December 31, 2021, our distribution network maintain approximately five weeks of inventory. Overall, we continue to deploy our financial resources to focus on advancing of neratinib through ongoing clinical trials and the commercialization of NERLYNX.

Alan Auerbach

25:14 Thanks, Maximo. The COVID-19 pandemic has continued to present commercial challenges to Puma, as even with the vaccinations that have been administered in 2021, we still are noting that various to commercial access are still in place. We are hopeful that with COVID cases declining, these varies will reduce in the future, which should improve the ability of our commercial team to access and interact with health care providers to increase their awareness of the NERLYNX data.

25:41 We also recognize the uncertainty as to why an access to health care providers improve and we are remaining conservative in our outlook for improvements and access for this year. Puma’s senior management in cooperation with the Board of Directors continues to remain focused on improving NERLYNX sales in 2022 and beyond. In the fourth quarter of 2021, we implemented a reduction in expenses with the goal of reducing expenses in order to maximize operational cash flows. The company remains committed to protecting these operational cash flows and we'll continue to reduce expenses if needed to achieve this. We look forward to updating investors on this in the future.

26:22 There continues to remain a significant unmet need for patients battling breast cancer, lung cancer and other solid tumors, we at Puma our 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.

26:39 This concludes today's presentation. We will now turn the floor back to the operator for Q&A. Operator?

Question-and-Answer Session


26:46 We will now begin the question-and-answer session. [Operator Instructions] Your first question comes from Ed White with H.C. Wainwright. Please proceed with your question.

Edward White

27:15 Good afternoon. Thanks for taking my questions. So, regarding the sales force, is the sales force right sized now and maybe if you can give us a little bit more information on virtual sales calls versus in person calls in the fourth quarter? How that compares to the third quarter and what you're seeing so far in 2022?

Alan Auerbach

27:40 Hi, Ed. Let me answer your second question and then I'll have Jeff answer the first one. In terms of the virtual calls versus live, it's running about 50-50, about half of the calls are in person half of being done virtually. We haven't really seen that change a whole lot yet. We're hopeful it will change more during the year. In terms of the size of the sales force Jeff is going to comment please.

Jeff Ludwig

28:04 Yeah. Sure, happy to. And I believe we've got the right size for the opportunity here. As I mentioned, we made this change, certainly not just to maximize resources, but to really capitalize or right sized for the change in the oncology marketplace. There are more and more customers that have gone to virtual or preferred virtual including some continued accounts that are not accessible. So, it has allowed us to reduce our footprint, but ultimately, we feel still be able to cover the vast majority of our business. And I know this question was asked on the last call as well, we will pay very close attention to this product. This is promotionally sensitive. If we come to the point where we cannot get in front of the right customers to improve our business, we will make a business case and adjust that appropriately. But right now, we feel very good about the size and is part of that structure we put all elements of our sales force, our CNEs, our clinical nurse educators, our clinical specialists or sales reps and our strategic account managers under a local leadership team, so they can make right decisions in a quick efficient and hopefully rapid fashion. So, we feel good about it.

Edward White

29:16 Thanks. You mentioned if the distribution networks at the year-end about five weeks of inventory are there, what do you expect to see throughout 2022 more like the four weeks of inventory stocking?

Alan Auerbach

29:33 Yeah. So, we always see in the four quarter an inventory buy in and that's something we've seen every year. Our anticipation is and Maximo commented this in his comments, we saw the inventory buy in which was roughly 345 bottles in Q4. We're expecting to see that burn down in Q1. And so, because of that burn down, it's going to impact our Q1 sales and we see that trend if you look at the figure we put up, we see that trend every time. Our current expectation is that inventory will remain flat Q3 to Q4, -- I'm sorry, Q2 and Q3 and then come back up in Q4 again, as you get the inventory buying again.

Edward White

30:16 Okay. Great. Thanks, Alan. That's what I was looking for. And then just sticking a bit more about strategy and business development. How -- are you looking at any potential targets now, or are you looking at anything perhaps early stage products or late-stage products or even currently marketed products that you can use leverage your sales reps to obtain value. I just wanted to get your thoughts on your BD development? Thanks.

Alan Auerbach

30:49 Yeah. Thanks for asking, Ed. We've always been evaluating additional drugs to in-license. We tend to be more of a product centric company and that of technology centric one meaning, we're not likely to get involved in any platform that requires a big preclinical R&D investments. The company is a, what's called an NRDL. So, in our research development only, do we feel there are early stage clinical assets that could be developed, I think that's a fair assumption. Certainly, as we are going to have a lot of operating cash flows this year, assuming, we hit our numbers, and all the numbers come in and we think they're going to in our expenses stay where they are, or go down and investing that cash flow in other assets certainly would it make sense as a way to contribute value to stockholders. Obviously, we would be very picky and we would not look for something that would have a negative impact on those cash flows.

Edward White

31:55 Great. Thanks, Alan for taking my questions.

Alan Auerbach

32:01 Sure.


32:04 Your next question comes from Yigal Nochomovitz with Citi. Please proceed with your question.

Carly Kenselaar

32:09 Hi. This is Carly on for Yigal. Thanks so much for taking our questions. We were just hoping you could go into a bit more detail on the discussion you had with the FDA last quarter on the path forward for HER2 mutated breast cancer. I guess given the FDA had previously requested the amendment to SUMMIT to isolate the effect of neratinib in the randomized stage one portion. I was just curious why you now believe the FDA could potentially require another study -- another randomized study here? Thank you.

Alan Auerbach

32:43 Yeah. Thanks, Carly. The randomization they required was to randomize the patients to either neratinib plus Herceptin plus fulvestrant versus Herceptin fulvestrant versus fulvestrant alone. Those would not be considered the standard of care, if you will, for that industry and it was only seven patients. I think that if they do require us to do a randomized trial, I would expect it would probably be where we have to throw in something that represents the current standard of care for ER positive patients, which will probably be something of a physician's choice type of thing, so you're correct. The purpose of the randomization was to isolate the effects of neratinib but I don't think -- number one, I don't think only seven patients would be a standard of care. But more importantly, I don't know that fulvestrant alone would be a standard of care in that setting either, so I think that's where the -- if the FDA requires one that would be probably the hypothesis as to why.

Carly Kenselaar

33:46 Okay. Got it. Thank you for taking the question.


33:52 Your next question comes from Marc Frahm with Cowen. Please proceed with your question.

Marc Frahm

34:00 Thanks for taking my question. You just answered what was going to be first one on breast question, maybe just a similar question on kind of what that randomized trial would look like on the lung cancer side for those discussions later in the year and kind of what the expectations are there?

Alan Auerbach

34:16 Yeah. Hi, Marc. I don't know the answer to what it would look like, my assumption would be. So, we would probably be looking at patients with EGFR exon 18 mutated lung cancer. There would be patients who already had an EGFR tyrosine kinase inhibitor. So again, if they will take a single-arm trial then that will be the way to proceed if they need a randomized trial. I would assume it against there in a Pierre. I don't know until we talk to them and again these are both small indications. So, it would if again if they want a single-arm trial, we can certainly look at what the ROI on that would be, if they want to randomized one, we would need to look at what the ROI is given the market opportunity and certainly at the time that we take in the money we take to do that. Again, we want to protect our operational cash flows. It's very important to us to do that. And so, it's obviously that's the decision, we need to make.

Marc Frahm

35:15 Okay. That makes sense. And then maybe there is any updates you can provide on the T790M patent cases and prosecuting that pattern?

Jeff Ludwig

35:28 Yeah. So, Marc regarding the T790M IP that Puma has, as I'm sure you can imagine the topic you're discussing in the very sensitive legal matter, and so there's not really how much we can comment on.

Marc Frahm

35:43 Okay. Fair enough. Thank you.


35:45 Your next question comes from Geoff Meacham with Bank of America. Please proceed with your question.

Alex Hammond

35:53 Hi. This is Alex on for Geoff. Thank you for taking my question. Can you provide any color on why the Phase II data from the SUMMIT trial of neratinib and typical cancer patients with HER2 mutations was pushed from the first half to the second half? Thank you.

Alan Auerbach

36:08 Yes. In terms of the data for neratinib in HER2 mutated cervical cancer and moving it from first half to the second half. We did not -- it get data together in time to submit it to SGO, which would be the conference we were looking for. So therefore, we're going to be the next conference we were able to do it at is in the second half.

Alex Hammond

36:31 All right. Thank you.

Alan Auerbach

36:33 If I remember off the top of my head. It's the ahead. I think we were shooting for ESMO for that one. It's really just a timing issue we couldn't get it done for the FGL deadline.


36:47Thank you. Our next question comes from the line of Gena Wang with Barclays. Please proceed with your question.

Unidentified Participant

36:53 Hi. Thanks for taking our questions. This is Tom (ph) for Gena. We just wanted to ask about -- we have two questions and first one about lung metrics and can you just remind us about current complaint rate and implementation of the profit treatment for diarrhea, is there any change? And my second question is thinking about the growth opportunity in 2022, how much cost of impact do you expect from the recent guidance update as well as the China reimbursement program?

Alan Auerbach

37:25 Yeah. I'm sorry can you repeat those questions. We didn't hear it quite well. So, if you can speak up a little bit greatly appreciate that, please.

Unidentified Participant

37:33 Sure. So, the first question is about, can you remind us about the current compliance rate and profit treatment for diarrhea, is there any change there and also other metrics if you can have more color on that front? The second question is about I think about the revenue growth opportunity in 2022, how much positive influence from recent NCCN guidance update as well as China reimbursement program.

Alan Auerbach

38:07 So in terms of the compliance rate, if you will, the main diarrhea prophylaxis that we're looking at is the use of the dose escalation, as Jeff put in his slide, we have seen that increased quarter-over-quarter. We would expect that that would continue as we increase awareness of it. And as you mentioned, it's in the NCCN guidelines as well. And regarding the how much influence the NCCN guidelines will have on revenue going forward, we are certainly hopeful that the improvements of the guidelines adding relative to the body will have a positive influence. And in terms of the China that's going to be a very major influence on our numbers positively. The market for HER2 positive breast cancer in China is probably 2 times to 3 times in terms of number of patients, what it is in the U.S. and certainly being added to the NRDL, which means that the government is reimbursing it. It's a wonderful thing for patients and obviously we’ll have a very positive impact on our numbers. So, as you heard in our guidance, we're expecting a very big ramp-up in our royalties and that is -- all of our partners are showing growth, which is wonderful. And then in Europe, we're showing good growth, et cetera, but the big jump up is the China revenue there.

Unidentified Participant

39:31Maybe, did you mention the compliance rate, the current compliance rate there any change there?

Alan Auerbach

39:42 When you say compliance rates, can you clarify.

Unidentified Participant

39:46 Like patient when they started and stay on the payment?

Jeff Ludwig

39:53 So let me try to address that. We do measure cohorts of patients, really by quarter. And as you look at and we do expect as the adoption of dose escalation continues. You'll see a lower discontinuation rate and hopefully an extension of overall length of therapy. The bulk of our patients have come on therapy on dose escalation in the last six months to nine months. So, we don't have a full assessment of that yet, but I can tell you that feedback from customers is very positive around dose escalation, it's easier for patients, easier for nurses and easier for customers and we've got pretty strong podium support from some of our KOLs about implementing dose escalation as well.

Unidentified Participant

40:35 Thank you.


40:39 Thank you. This concludes our question-and-answer session. I would like to turn the conference back over to Mariann for closing remarks.

Mariann Ohanesian

40:47 Thank you all for joining us today. As a reminder, this call may be accessed via replay of the webcast at pumabiotechnology.com beginning later today. Have a good evening.


41:01 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.

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