Good afternoon. My name is Victoria, 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. You may begin your conference.

Thank you, Victoria. Good afternoon and welcome to Puma’s conference call to discuss our financial results for the second 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 second quarter 2023 earnings results. That news release, the slides that Jeff will refer to, and a webcast of this call are accessible via the homepage and Investors sections of our website at pumabiotechnology.com. The webcast and presentation slides will be archived on our website and available for replay for the next 90 days. Today’s conference call will include statements about the company’s future expectations, plans, and prospects that constitute forward-looking statements for purposes of Federal Securities laws. Such statements are subject to risks and uncertainties and actual 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, August 3rd, 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 second quarter 2023 news release for a reconciliation of our GAAP to non-GAAP results. I will now turn the call over to Alan.

Thank you, Mariann and thank you all for joining our call today. Today, Puma reported total revenue for the second quarter of 2023 of $54.6 million. Total revenue includes product revenue net, which consists entirely of NERLYNX sales, as well as royalties from our sub licensees. Product revenue net was $51.6 million in the second quarter of 2023, which represents increases as expected from $46.8 million reported in Q1 2023 and $51.3 million reported in Q2 2022. Product revenue for the second quarter of 2023 was impacted by approximately $1.5 million of inventory drawdown at our specialty pharmacies and specialty distributors. Royalty revenue was $3 million in the second quarter of 2023 compared to $6 million in Q1 2023 $8.2 million in Q22 2022. We reported 3022 bottles of NERLYNX sold in second quarter of 2023, an increase of 173 from the 2,849 bottles sold in Q1 of 2023. As I noted on last quarter's call, we estimate that inventory increased by about 164 bottles in Q4 2022 and then subsequently declined by about 236 bottles in Q1 of 2023. In Q2 2023, we estimate that inventory was further reduced by about 89 bottles. In Q2 2023, new prescriptions or NRx were down approximately 12.5% compared to Q1 2023 and total prescriptions were up approximately 0.4% compared to Q1 of 2023. Jeff will provide further details in his comments and slides. I will now provide a clinical review of the quarter. Then, Jeff Ludwig will add additional color on NERLYNX commercial activities, Maximon Nougues will follow with highlights of the key components of our financial statements for the second quarter of 2023. In our investor call in October 2022, we announced that we had in-licensed the anticancer drug alisertib from Takeda. In clinical trials to-date, alisertib has shown single-agent activity…

Thanks Alan. Appreciate it, and thanks, everyone, for joining our second quarter earnings call. Before I move into the commercial review, just a reminder that I will be making forward-looking statements. Let me start with just a brief overview of our commercial strategy. We remain largely focused on the extended adjuvant indication where we believe there continues to be significant unmet need, especially for patients at higher risk of recurrence. We are continuing to refine our targeting for both our personal and non-personal promotion with the goal of being more efficient and more effective with our given resources. In addition, the team continues to look for opportunities to expand our engagement with local and regional advocacy groups, ultimately to better educate and support patients throughout their treatment journey. We believe NERLYNX is a promotionally sensitive product and are happy to see that our teams are making progress increasing our reach and frequency with HCPs. With that said, oncology is still a very restricted therapeutic area from an access standpoint and getting in front of customers at the right time can be more important given the various treatment decisions and the overall duration of treatment. Our sales and marketing teams are working closely together with the goal of driving sustained improvements in our reach and frequency and increasing engagements that are deemed valuable and motivating. With that high-level update, let me transition to some of the U.S. commercial slides where I will provide some additional insights. Once I have finished, I will turn the call over to Maximo for a more detailed review of our financial results. Slide three provides an overview of our distribution model. This model has not changed and remains separated into two distinct channels that provide NERLYNX to patients. We refer to these two channels as our…

Thanks, Jeff. I will begin with a brief summary of our financial results for the second quarter of 2023. Please note that I will make comparisons to Q1 2023, 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 Q2 2023 10-Q, which will be filed today and includes our consolidated financial statements. For the second quarter of 2023, we reported net income based on GAAP of $2.1 million or $0.05 per share. This compares to a net income in Q1 2023 of $1.4 million or $0.03 per share. On a non-GAAP basis, which is adjusted to remove the impact of stock-based compensation expense, we reported net income of $4.6 million or $0.10 per share for the second quarter of 2023. Gross revenue from NERLYNX sales was $62.8 million in Q2 2023 and $59.4 million in Q1 2023. As Alan mentioned, net product revenue from NERLYNX sales was $51.6 million compared to $46.8 million reported in Q1 2023. We believe that Q2 net sales were impacted by approximately $1.5 million of inventory drawdown from our distributors versus approximately $3.8 million of inventory drawdown in Q1 2023. Royalty revenue totaled $3 million in the second quarter of 2023 compared to $6 million in Q1 2023. The lower royalties versus Q1 reflects the timing of shipments to our partner in China. Our gross to net adjustment in Q2 2023 was about 17.9% compared to the 21.2% gross to net adjustment reported in Q1 2023. Lower co-pay, government charges and Medicare rebates were the main drivers of the decrease versus Q1 2023. Cost of sales for Q2 2023 was $11.9 million, including $2.4 million for the amortization of intangible assets related to our neratinib license. Cost…

Thanks Maximo. We are pleased to report positive net income as well as positive cash flow during the second 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 operational cash flows. We believe that the positive net income and cash flow reported in the second quarter reflect these expense reductions. These expense reductions are also a major contributor to the positive net income and positive cash flow that Puma is guiding to for the 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 at helping these patients during their journey and we will continue to strive to achieve that goal. This concludes today's presentation. We will now turn the floor back to the operator for Q&A. Operator?

Thank you. We will now being the question-and-answer session. [Operator Instructions] First question comes from Ed White with H.C. Wainwright. Please go ahead.

Good afternoon. Thanks for taking my questions and congratulations on the quarter. So, just a couple of questions on sales. I might have missed it, but did you give the percentage of live interactions in the second quarter? I believe in the first quarter, you mentioned it was 81%. And is this number taking now?

Ed, thanks for the question. This is Jeff. And I'm sorry, I did not have that in the script, I apologize. In Q1, it was 81% from live. In Q2 is very similar. It's reported around 81% to 82% live versus virtual. So, we still see the vast majority of our calls being live. I'm not seeing the same inflection. I would expect that we're going to see that combination likely to continue for the foreseeable future.

Great. Thanks. And I'm just wondering if you had the NCCN guidelines were changed updated, I should say, on February 1st. Are you seeing any impact to sales based on those guideline changes yet? Or should we expect to see it in the future?

So Ed, we were very happy that NCCN changed that. And we feel like that, that validates some of the things we're trying to do. As you may know, they moved NERLYNX up into the body of the guidelines, which we feel is a much more prominent position. Where they added NERLYNX was in the useful in certain circumstances section. And ultimately, what it said was consider using NERLYNX for patients at higher risk of reoccurrence. We love that positioning, it's more prominent, but the words considered puts the onus -- continued on the sales team to get in front and validate and justify those. So, although we see it as a positive trend, we think it's really up to my sales team and the commercial team to pull that through, educate around that and also continue to provide the benefits of NERLYNX in those patients. Hopefully, that adds some more color.

It does. And perhaps just the last question I have on the sales are what really is going to move the needle for NERLYNX over the next 12 months? As you said that, it seems like you're having more interactions. The NCCN guidelines really haven't had much of an impact without you're pushing for it. So what do you have left in your repertoire to increased sales?

Yes, very good question. I appreciate it. Where we're focused in terms of trying to inflect NERLYNX is on a couple areas. Number one, we still don't believe that the -- that we've done a strong enough job embedding the evolution of the clinical data. So the prime focus of the commercial team is to update and educate around that evolving clinical data, especially around those subgroups of increased levels of risk, focused on iDFS, OS, CNS and duration. We want to continue to embed that. So customers know that data inside and out. That's number one. Number two, we are trying to help our sales team as you think about the HER2-positive breast cancer patients, spread across a large number of community oncologists where access is not as strong as we would like. What we're trying to do is to help the sales force spend more time in front of those customers that are more likely to have more of those appropriate patients. So that increased share of voice we're trying to focus that in on places where you have a greater return on that discussion. Two other things I'll throw out. I mentioned access can be tough in the community setting. We are working hard to increase our non-personal promotion. So in places we cannot get in front of, we're trying to support that through non-personal message to get that education across as well. And lastly, as I mentioned, in the extended adjuvant setting, we believe patients can play a significant role in asking their doctor about what else can I do to reduce my risk. So we're trying to increase that partnership with local and regional advocacy groups, so patients are more educated and engage more frequently on asking for other options to reduce the risk. Those are the 4 things we're focused in on right now to drive that business.

Great. Thank you. And perhaps a pipeline question just on alisertib. You're planning on meeting with the FDA for the HR-positive HER2-negative breast cancer indication. What are your expectations for that meeting with the FDA? Alan, what are you thinking would be a home run here? What are you thinking that would be the path forward?

Yes, thanks for the question Ed. We've seen alisertib tested in two different settings in HR-positive HER2-negative breast cancer. One is in combination with endocrine therapy and the other is in combination with chemotherapy, specifically with paclitaxel, the endocrine was with fulvestrant. The fulvestrant combination is obviously used early in the treatment guideline and in the treatment regimen. So obviously, we have a larger potential patient population. In our meetings with the KOLs, they have definitely pushed for using alisertib earlier rather than later. So they've pushed more for the combination with fulvestrant or some other endocrine in kind of that endocrine phase of treatment kind of the -- before chemo part. So I don't know if there's any setting that's "a home run" I think we'll have a very productive discussion with the FDA. It will be very helpful and interactive. I don't really -- there's no scenario that I view "a home run". I would imagine we will just be discussing with them the path forward for that combination and what the eventual Phase 3 trial would need to look like.

Okay, great. Thanks Alan. For taking my questions.

Next question comes from Divya Rao with TD Cowen and Company. Please go ahead.

Good afternoon. This is Divya on for Marc. Thanks for taking our question. We have two questions mostly on the pipeline. Just to clarify on the Phase 2 trial of alisertib and small cell, will all the patients be enrolled and then tissue -- and then have their tissue biopsy during the interim cut to then evaluate the subgroup analysis? Or will the patients be screened for the presence of biomarkers before they're enrolled into the trial?

The patients will have -- so we'll be pre-specifying -- the way we're looking to do this is to pre-specify upfront the biomarkers we're going to look at. We'll do the tissue biopsy at study entry and then we're meant to do the trial in a way that we're constantly looking at the biomarkers. And so if there's a need to kind of enrich a population because we're seeing a signal, we can do that.

And then for the pembro combination trial that is hoping to -- that you're hoping to read out in the second half. What is the kind of scope of that data readout going to be? And possibly is there a venue that you're thinking of for that disclosure?

Yes. So it's an investigator-sponsored trial, so we have not as much interaction on that. And our last communication with the investigator -- the investigator incident, they were looking to submit it to the molecular targets meeting. I believe that we're looking to do it as a late breaker. So that's the last update we have on that.

Got it. Thank you so much.

Next question comes from Geoff Meacham, Bank of America.

Hi, this is Alex Hammond on for Geoff. Thank you very much for taking our question. Can you talk a little bit about your BD strategy? You touched on it a bit during your prepared remarks, but what would be your criteria or your preference for the type of products that you are going to potentially in-license?

I think we will be looking at focusing more in the solid tumor space because that's where our -- both our commercial sales force and our kind of R&D domain knowledge is. And I think we'd be looking at -- we obviously would be looking at potential commercial assets, although I think that in the solid tumor space has its challenges. And then ones that are in various stages of clinical development as well.

Thanks.

Next question comes from Gena Wang with Barclays. Please go ahead.

Hi, good afternoon. This is Harshita on for Gena. Thanks for taking our question. So I just had a quick one on the alisertib small cell development pathway. I was curious, did you discuss with the FDA what a confirmatory trial would look like if you were able to go through an accelerated approval path based on the Puma ALI-4201 trial you disclosed today?

So normally, when you're going for an accelerated approval pathway, you go in with a Phase 2 trial and you try to have the conviction that, that's going to result in a positive randomized trial. Well, obviously, we have the randomized Phase 2, where in the biomarker subgroups, we have shown a PFS and OS benefit. So now we're kind of going backwards to try to find the monotherapy trial, monotherapy subgroup that would correlate with what we saw in that randomized trial. I would imagine that the randomized trial would be very similar to what was published in the Journal of Thoracic Oncology, which would be the kind of paclitaxel alisertib against paclitaxel placebo. That would be my assumption, although it would be one that would be prospectively looking for that biomarker subgroup. So the only patients enrolled would have that biomarker. So it would be similar but different from what was done previously.

Very helpful. Thank you so much.

-- our question-and-answer session. I would like to turn the conference back to Mariann for closing comments.

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