Good afternoon. My name is Paula 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. I would now like to turn the conference call over to Mariann Ohanesian, Senior Director of IR for Puma Biotechnology. Please go ahead. You may begin.

Thank you, Paula. Good afternoon and welcome to Puma's conference call to discuss our financial results for the first quarter of 2020. Joining me on the call today are Alan Auerbach, Chief Executive Officer, President and Chairman of the Board of Puma Biotechnology; and Maximo Nougues, Chief Financial Officer. After market close today, Puma issued a news release detailing first quarter 2020 financial results. That news release, the slides that Alan 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. 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 due to a number of factors, which include the risk factors disclosed in the periodic and current reports, filed by Puma with the Securities and Exchange Commission from time to time. 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 7, 2020. The company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this 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, are GAAP financial measures. Please refer to our first quarter 2020 news release for a reconciliation of our GAAP and 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 first quarter of 2020 of $51.2 million. Total revenue consisted of license revenue of $2 million, royalty revenue of $0.6 million and net sales of NERLYNX of $48.6 million. Net sales of $48.6 million in the first quarter of 2020 and represented a decline from the $58.7 million in net sales reported in the fourth quarter of 2019 and an increase of 6.7% from the $45.6 million reported in Q1 of 2019. I will begin with a review of some of the highlights of the quarter and then provide more details on NERLYNX' commercial activities in the US. Maximo Nougues will follow with highlights of the key components of our financial statements for the first quarter of 2020. As investors are aware, in the second quarter of 2019, we presented results from our Phase III trial of neratinib in third-line HER2-positive metastatic breast cancer also known as the NALA trial at the American Society of Clinical Oncology Annual Meeting in June. Based on the results of the NALA trial, Puma filed a supplemental new drug application or sNDA for neratinib, for the treatment of third line HER2-positive metastatic breast cancer in June of 2019. The sNDA was accepted by the FDA in September 2019 and NERLYNX was approved in this indication in February 2020, two months before our anticipated PDUFA date. As investors are also aware Puma has an ongoing basket trial of neratinib in HER2 mutated cancers referred to as the SUMMIT trial. The SUMMIT trial was modified in early 2020 and such that ER-positive HER2-negative breast cancer patients, who have a HER2 mutation, will be randomized to receive either fulvestrant alone, fulvestrant plus trastuzumab and or the combination of…

Thanks Alan. Let me start with a quick summary of our financial results for the first quarter of 2020. Please note that I will make comparisons to Q4 and Q3 2019, which we believe are better indications of our progress as a commercial company and year-over-year comparisons. For more information, I recommend that you refer to our 10-Q, which will be filed today and includes our consolidated financial term. For the first quarter of 2020 we reported a net loss based on GAAP of $15.9 million or $0.43 per share. Our GAAP net losses for Q4 and Q3 2019 were $11.2 million and $16.9 million, respectively. On a non-GAAP basis, which is adjusted to remove the impact of stock-based compensation we reported a net loss of $8 million or $0.20 per share for the first quarter of 2020. Gross revenue from NERLYNX sales was $58 million in Q1 2020 versus $68.5 million in Q4 2019. As Alan mentioned, net revenue from NERLYNX sales was $48.6 million, a decrease from net sales of $58.7 million for the fourth quarter of 2019. In Q1 2020, we recognized $2 million of license revenue related to our metastatic approval and $0.6 million in royalty revenue from our global partners. Our gross to net adjustment in Q1 was about 16%, an increase from the 14% gross to net adjustment in Q4. The increase was driven mostly by higher co-pay and coverage GAAP expenses driven by seasonality. Cost of sales for the first quarter was $9.1 million, which included amortization of milestone payments to the licensor of neratinib of approximately $1 million. Going forward, we will continue to recognize amortization of the milestone payments to the licensor for about $1 million per quarter as cost of sales. For the fiscal year 2020, Puma continues to anticipate…

Thanks, Maximo. We continue to recognize that we need to improve NERLYNX sales growth. Puma senior management, in cooperation with the commercial Committee of the Board of Directors, continues to remain focused on NERLYNX' revenues and sales growth in 2020 and beyond. We have made a number of new hires in our commercial team and we are hopeful that these new team members will make a positive contribution to NERLYNX' sales growth and we look forward to updating investors on this in the future. There remains a significant unmet need for women battling breast cancer. We at Puma are committed and passionate about finding more effective ways and helping these patients during their journey and we will continue to strive to achieve that goal. This concludes today's presentation. We will now turn the floor back to the operator for questions. Operator?

We will now begin the question-and-answer session. [Operator Instructions] And the first question will come from Yigal Nochomovitz with Citigroup.

Hi. Great. Thanks for taking the question. I just had a few. Alan, can you comment at all about how much metastatic revenue you generated in the first quarter? I know you just got the approval, but I'm just curious if you could provide any comments on that.

Yes. Hi, Yigal. Thanks for the questions. So to give kind of a comparison, In Q4 of 2019, 8.9% of our bottles sold were in the metastatic setting. But some of that is in the HER2 amplified and some of that is in the HER2 mutated. In Q1 of 2020, it was 9.3%.

Okay. Got it. That's very helpful. And then, just, I want to get a better understanding with respect to the guidance. I know you mentioned that you're going to take a conservative approach with respect to the sales trends this year. And I think you also mentioned that Q2, you expect $48 million to $50 million. So that -- maintaining the guidance of $215 million to $225 million suggest you are still expecting some growth in the back half of the year. I just wondered if you could comment on that in view of the situation with COVID and where you're comfortable maintaining that $215 million to $225 million range. Thanks.

Yes. So again we are taking a conservative outlook with regard to COVID-19, because I think that there's a lot of uncertainty in terms of when the country opens up? What that looks like? Do we see a second surge et cetera. We do feel obviously a lot more comfortable that towards the second half of 2019, access will be higher. And so I think that's where that guidance is coming from. That's kind of being conservative now and recognizing that as access improves later in the year that should obviously help sales growth as well.

All right. Appreciate it. Thank you.

Moving on we'll go to Cory Kasimov with JPMorgan.

Hey, guys. This is Matthew [ph] on for Cory. Thanks for answering my question. So I just wanted to follow up on the question on 2020 guidance. Does that factor in another price increase beyond what was taken in March?

I don't remember if there was one that was planned for later this year. I don't have that information in front of me. I don't remember the answer to that.

Okay. And then I guess just for the metastatic opportunity. Curious to understand what you're hearing in the field. And I guess my question is do you expect to see patients undergoing multiple treatment regimens with capecitabine recycling through to given that there are multiple TKIs approved in combination with capecitabine?

That is a good question. I would say that in terms of the use of NERLYNX in the metastatic setting we do again anecdotally we hear from physicians that they use NERLYNX sometimes just as a single agent, right because it's very well published. The drug works as a monotherapy. And sometimes they use it in combination with chemo sometimes it's capecitabine sometimes it's not. We also hear quite frequently that they're using it for HER2 mutated patients as well because there's a tremendous amount of data published on HER2-mutated breast cancer. You've obviously had three new drugs approved in kind of this third line and beyond HER2-positive metastatic breast cancer setting. As you know – and HER2 which is the ADC from AstraZeneca and Daiichi Sankyo was approved in December of 2019. Then NERLYNX was approved in February and then most recently tucatinib from Seattle Genetics approved. Obviously in HER2 came out launched it in the space prior to us being able to and prior to the COVID-19 pandemic our bottles in the metastatic went from 8.9% in Q4 of 2019 to 9.3% in Q1 of 2020. So short term it did appear that in HER2 had the impact on our metastatic sales. That's short term obviously. How it ends up playing out in terms of sequencing of other TKIs with capecitabine et cetera? I don't know the answer to that. I think we're just going to need to wait and see.

Great. Thanks for taking my question.

Moving now we'll go to Michael Schmidt with Guggenheim.

Hey, Alan. Thanks for taking my questions. Maybe a question just a financial question. I appreciate that you're maintaining NERLYNX sales guidance. Just wondering any updated thoughts on kind of roadway to cash flow breakeven? Is it something that you think might be achievable this year for example?

Yes. This is Maximo. Our goal for 2020 is to be cash flow neutral.

So we're maintaining that goal Michael.

Great. Thank you. And then maybe just another question on market dynamics. Just curious now that the drug's been on the market for some time, the majority of sales obviously coming still from the adjuvant setting. I'm just wondering if you've seen any changes here in market dynamics since Kadcyla had been approved last year in early breast cancer as well.

Yes. Thanks for that question Michael. So the data on Kadcyla in the adjuvant setting, the KATHERINE data was presented at the San Antonio Breast Cancer meeting in December of 2018, if I remember this correctly and I believe it was approved in April 2019. When the data came out at San Antonio, our understanding is that docs immediately began switching their patients to Kadcyla. So if they had a patient that was through six months of percept for [Indiscernible] they switched them to Kadcyla and they were starting all new patients on it as well. So throughout 2019 and into 2020 I would estimate that the large percentage of our patients have already previously seen Kadcyla. So I don't – we haven't yet to my knowledge seen any impact of that. And I don't know that I would anticipate that changing in the future.

Okay. And then maybe Massimo just to confirm. One – I'm not sure if I heard that earlier whether you guided to $48 million to $50 million in sales for the second quarter. Could you just confirm that?

Our guidance was $215 million to $225 million.

For the year, yes.

For the year. And for the – on the second quarter was – on the second quarter we said $48 million to $50 million.

Okay. Perfect. Thanks for the time.

And next we'll go to Kennen Mackay with RBC Capital Markets.

Hi. Thank you for taking the question. Maybe first initially, Alan that 0.4% increase in bottles sold in the metastatic setting after the approval translates to about 16 bottles or maybe 16 prescriptions given this was sort of on the market for about 1.5 months in Q1. Has this picked up at all in April given the NCCN COVID-19 guidelines to preferentially consider oral therapies whenever possible, or has this sort of been maintained – and maybe conversely to that has there been any impact to metastatic prescriptions that you've seen after the approval of tucatinib? And then second just on the Q1 guidance versus results. The outperformance versus the earlier bid wondering sort of where that came from and if there were any dynamics in the tail end of the quarter that has contributed to that? Thank you.

Okay. Ken, I have three questions from you. The first one is, do we see any change in metastatic prescriptions with NERLYNX in April after the NCCN COVID-19 preferentially said to prefer oral prescriptions. I don't know the answer to that. I don't have the data in front of me, so I can't answer that without the data. In terms of any impact from the approval of tucatinib, I know it was very, very recently. So I don't know if we have seen any. I don't remember, if we've seen any obviously that's something we'll be looking at, but I don't know that we've seen any to date yet. And I think we'll have to take a wait and see approach. Your last question in terms of the outperformance in Q1. Yes, you're correct. We guided to I believe it was $40 million to $42 million was our guidance for Q1 and we came in at $48 million. That was definitely driven by sales in extended adjuvants and we are definitely continuing to see new prescribers being a very big driver of sales. And I think our NRxs in Q1 if I had to ballpark it, I would say, 40% to 50% of them are coming from new prescribers. So, I know in the past, we had shown a metric that was how many prescribers. We had the reach, if you will. And again that was just defined as had we contact the doctor once, as I'm sure you can appreciate just contacting it after once often doesn't make them prescribe the drug. They often have questions and it could take 4 five or six calls to do that. So I think with time and with the increased efforts of the team to increase their outreach and increase their calls, especially to people who've not written a prescription I think that's likely what we're seeing is that execution from that perspective. If I had to estimate of the entire population of – which is probably ballpark somewhere in the range of 8,000 to 9,000 physicians I would ballpark estimate probably half of them if not more have yet to write a prescription for the drug. So there is clearly a continued opportunity to grow NRX through new prescribers. And that's something that the commercial team is going to be focusing on.

And maybe just a follow-up on that, any plans given some of these e prescriptions especially in extended adjuvant are starting at lower doses and either maintaining that or even looking at titrating. Any plans to release like a different tablet that could be priced the same on a monthly basis to maintaining some of that revenue recognition? Thank you.

Yes. Thank you. You asked that question, I believe on the last call as well. So thank you for asking it again. We are looking into that. We are indeed looking into that, Ken. And I understand the idea. I'm not at all disagreeing with you. It's a good idea. We are looking into that. I just think there's a little bit of lead time to get that done.

Perfect. Thank you.

And next we'll go to Chris Shibutani with Cowen & Company.

Good evening. This is CJ Zopf on for Chris tonight. Thanks for the thorough quarterly update. I was wondering, if following up on that last question getting into the NRxs with the kind of ongoing situation in hospitals and patients not seeing their physicians as much perhaps, is there any expectation for – or what efforts are ongoing that may enable you to kind of keep that momentum going in terms of growing new prescribers to keep the TRx as. And then perhaps, I may have missed this earlier but with respect to the patients starting on lower doses, do you have a sense yet of what the average duration of treatment might be by the end of the year as more and more prescribers adopt that? Thanks.

Yeah. Thanks, CJ. So to your first question in terms of what's happening with COVID-19 and how we are addressing that. Yes, you are correct that you do have a lot of patients who are not going to see their doctor because of the COVID-19. And I will again state as we get in our prepared comments that the commercial team is definitely working hard to try to adapt to this new environment. And doing a lot of non-personal interactions we're more virtual ones and things like that. And as states start to open up obviously that helps them as well because it opens up access as well. So now they can kind of do more face-to-face meetings or rather than doing a big Webex call or something like that actually meet the physical location or restaurants or something like that. So, as the states open up, that will, obviously, help that tremendously. Your second question we do not have -- I don't have it in front of me what the estimate is in terms of people who are dose escalating and is it leading to a longer duration or not. I don't have that information in front of me. I think we have to a little longer to see that.

And next we'll go to Paul Choi with Goldman Sachs.

Hi, good afternoon Alan and thanks for taking our questions. My first question is just as you've gone partway through the second quarter here could you maybe just comment on any behavioral changes that you're observing with patients whether it's with regard to adherence and/or ability or follow through in terms of refilling descriptions?

Yes. Paul thanks for the question. In terms of adherence I don't know if we -- I get a question from investors quite a lot. Which is because people are stuck at home and therefore the side effects of the drug may not be as bothersome because they're not working and doing their daily activities. Are you seeing better compliance due to that? And I get that question quite frequently from investors. I don't know that we have enough data yet to be able -- I understand the thesis. I don't know we have enough data yet to be able to say yes or no on that. So, I need a little more data to be able to say that. In terms of patients refilling their prescriptions, et cetera through the specialty pharmacy this is a specialty pharmacy. This is not a CVS or a doing rebate, you just walk into. This is something where it's physically delivered to the patients. So, I would envision that most of these are doing like hands-off deliveries where they can just ring the doorbell even on the front doorstep or I would imagine they're probably showing up in a mask in gloves and all these things as well to help make the patient more comfortable. So, there isn't the need for the patient to physically go to a pharmacy. It's physically delivered to them. So, I don't know that that the question you're asking which is or patients refilling less frequently because they're not able to go to pharmacy or something. They don't think we go to a pharmacy. It's brought to them.

I was referring maybe more to any macro-driven impact where patients are potentially dropping off to do either unemployment or insurance versus delivery mechanism? Sorry if I was unclear.

Yes, that's a good question. With the spike in unemployment have we seen not to my knowledge I'm not aware that we have seen any drop in insurance coverage or anything like that. I would -- I'm talking off the top of my head here, but if I remember correctly usually if you're unemployed you can do--

COBRA.

Yes. COBRA. Thank you. You can do COBRA to keep your benefits going for a certain period of time. So I would imagine a lot of these patients would have that opportunity. Again I just haven't seen any data that says that we've seen due to the unemployment rise any drop-off in insured patients.

Got it. And then maybe just looking down the road a little bit here as you think about the cervical opportunity and post your discussions with the FDA for a potential accelerated approval here. Can you maybe just comment on where you think you are currently with regard to the commercial build market development and market research? And just how you think about perhaps the expansion of the field force over the course of 2021 and beyond?

Yes. So, thanks for that question Paul. We do have an opportunity with the SUMMIT trial. Both in HER2 mutated breast cancer and in HER2 mutated cervical cancer. HER2 we said at breast is a much larger indication than is HER2 mutated cervical. Because we already have the commercial infrastructure and the sales outreach to breast cancer physicians I don't anticipate we're going to need any additional build to do that. We do have a very strong marketing team, market access team, medical affairs team, et cetera who has been very involved in our work in HER2 mutated breast cancer. So, I anticipate that we're at this juncture quite well positioned for 2021.

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

Thank you for your interest in Puma Biotechnology. 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.