Earnings call: Puma Biotechnology reported a total revenue reaching $47.1 million

In their recent earnings call, Puma Biotechnology (ticker: NASDAQ:) reported a net loss of $4.5 million for the second quarter of 2024, with total revenue reaching $47.1 million. The company’s product revenue net was $44.4 million, primarily from their drug NERLYNX, which saw a quarter-over-quarter increase in bottles sold. Puma is focusing on expanding the use of NERLYNX in the extended adjuvant setting and has secured regulatory approvals in Brazil and Saudi Arabia. Despite a decrease in new patient starts and total prescriptions year-over-year, Puma anticipates net NERLYNX product revenue to be between $183 million and $190 million for the fiscal year 2024. The company expects to achieve a net income of $12 million to $15 million for the full year while maintaining flat total operating expenses and reducing SG&A expenses.

Key Takeaways

• Puma Biotechnology’s Q2 2024 revenue was $47.1 million, with NERLYNX contributing $44.4 million.
• NERLYNX bottle sales increased quarter-over-quarter but decreased year-over-year.
• The company expects full-year net NERLYNX revenue of $183-$190 million and net income of $12-$15 million.
• SG&A expenses are projected to decrease by 8-12%, and R&D expenses to increase by 16-19%.
• Puma aims to maintain positive net income and has a strong focus on NERLYNX sales trends.

Company Outlook

• Puma Biotechnology anticipates net NERLYNX product revenue to be between $183 million and $190 million for fiscal year 2024.
• The company is aiming for a net income between $12 million and $15 million for the full year.
• Puma is focusing on reducing expenses to maintain positive net income.

Bearish Highlights

• New patient starts and total prescriptions for NERLYNX have decreased both quarter-over-quarter and year-over-year.
• There was a 17% decline in ex-factory bottle sales of NERLYNX compared to the previous year.

Bullish Highlights

• NERLYNX bottle sales have seen a 4% increase from the previous quarter.
• Puma has successfully received regulatory approvals for NERLYNX in Brazil and Saudi Arabia, potentially expanding their market reach.

Misses

• Puma reported a net loss of $4.5 million in the second quarter of 2024.
• Enrollments in clinical trials decreased 5% quarter-over-quarter and 11% year-over-year.

Q&A Highlights

• Puma clarified that there were no changes to the Q2 revenue guidance, apologizing for confusion caused by an erroneous website presentation.
• The company addressed the lumpiness in royalty revenues, attributing it to annual sales timing into the Chinese market.

Puma Biotechnology’s earnings call painted a picture of a company in transition, focusing on the commercial potential of NERLYNX while managing financial challenges. With a strategic emphasis on reducing expenses and increasing the drug’s market presence, Puma remains committed to achieving profitability in the upcoming fiscal year.

InvestingPro Insights

Puma Biotechnology (ticker: PBYI) has been navigating a dynamic market landscape and their recent financial results reflect a strategic focus on their flagship product NERLYNX. To provide additional context to the company’s performance and outlook, InvestingPro offers key insights and real-time data that can be valuable for investors.

An InvestingPro Tip suggests that Puma Biotechnology’s stock has experienced significant volatility, with a notable dip over the last week. This aligns with the company’s reported net loss for Q2 2024 but contrasts with a strong return over the last month. This volatility may be of interest to investors looking for potential entry points or considering the timing of their investments.

Another tip from InvestingPro highlights that analysts predict Puma Biotechnology will be profitable this year. This is particularly relevant considering the company’s own projections for net income and its focus on expanding NERLYNX’s market presence. A profitable outlook could signal a potential turnaround for the company, which investors may find encouraging.

From the real-time data provided by InvestingPro, three key metrics stand out:

• The company’s P/E Ratio (Adjusted) for the last twelve months as of Q1 2024 is 11.59, which is relatively low and may indicate the stock is undervalued compared to its earnings.

• Puma Biotechnology operates with a Gross Profit Margin of 73.44% for the same period, suggesting that the company is maintaining a strong profitability on its sales.

• The Revenue Growth (Quarterly) for Q1 2024 shows a decline of 17.07%, which could be a point of concern for investors looking at the company’s ability to grow its top line in the short term.

These metrics, combined with the InvestingPro Tips, provide a more nuanced view of Puma Biotechnology’s financial health and market potential. For investors seeking further insights, InvestingPro lists additional tips on their platform, which can be accessed for PBYI at https://www.investing.com/pro/PBYI.

Full transcript – Puma Biotechnlgy (PBYI) Q2 2024:

Operator: Good afternoon. My name is Diego and I will be your conference call operator today. [Operator Instructions] As a reminder, this conference 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.

Mariann Ohanesian: Thank you, Diego. Good afternoon and welcome to Puma’s conference call to discuss our financial results for the second quarter of 2024. 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 2024 financial results. That news release, the slides that Jeff will refer to, and a webcast of this call are accessible via the homepage and Investors sections of our website at pumabiotechnology.com. The webcast and presentation slides will be archived on our website and available for replay for the next 90 days. Today’s conference call will include statements about Puma’s future expectations, plans and prospects that constitute forward-looking statements for purposes of federal securities laws. Such statements are subject to risks and uncertainties and actual events and results may differ from those expressed in these forward-looking statements. For a full discussion of these risks and uncertainties, please review our periodic and current reports filed with the SEC from time-to-time, including our Annual Report on Form 10-K for the year ended December 31, 2023. 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 1, 2024. Puma 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 refer to certain non-GAAP financial measures that involve adjustments to our GAAP figures. We believe these non-GAAP metrics maybe useful to investors as a supplement to, but not a substitute for our GAAP financial measures. Please refer to our second quarter 2024 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 second quarter of 2024 of $47.1 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 $44.4 million in the second quarter of 2024 which was an increase from the $40.3 million reported in Q1 of 2024 and below the $51.6 million reported in Q2 of 2023. Product revenue for the second quarter of 2024 was impacted by approximately $2.3 million of inventory drawdown in our specialty pharmacies and specialty distributors. Royalty revenue was $2.7 million in the second quarter of 2024 compared to $3.5 million in Q1 of 2024 and $3.0 million in Q2 of 2023. We reported 2,515 bottles of NERLYNX sold in the second quarter of 2024, an increase of 105 bottles from the 2,410 bottles sold in Q1 2024. In Q2 2024, we estimate that inventory decreased by about 132 bottles. In Q2 2024, new prescriptions were down approximately 9% compared to Q1 2024 and total prescriptions were up approximately 3% compared to Q1 of 2024. 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 follow with highlights of the key components of our financial statements for the first quarter of 2024. As we have previously discussed, Puma has initiated a Phase 2 study of our investigational drug, alisertib to confirm the efficacy of alisertib monotherapy in patients with small cell lung cancer with biomarkers where aurora kinase pathway plays a role. The goal is to correlate the efficacy in these biomarker subgroups in the ALISCA-Lung1 study to the efficacy that was previously seen in the biomarker subgroups from the randomized trial of paclitaxel plus alisertib versus paclitaxel plus placebo that was published in the Journal of Thoracic Oncology in 2020. If the efficacy and biomarker data are comparable from the two studies, the company believes it could represent a potential accelerated approval strategy and would engage FDA to discuss this further. As investors will remember, alisertib was previously tested as a monotherapy in patients with small cell lung cancer. And the results of this trial were published in Lancet Oncology in 2015. In this trial, alisertib administered as a monotherapy to 48 patients with small cell lung cancer. The safety results from the study showed that 37% of the patients experienced Grade 3/4 neutropenia, 17% experienced Grade 3/4 anemia, 13% experienced Grade 3/4 leukopenia, and 10% experienced Grade 3/4 thrombocytopenia. And 13 patients discontinued treatment due to adverse events. It is believed that these adverse events are due to the alisertib mechanism of action as a cell cycle inhibitor. The efficacy results from the trial showed that for the 36 chemotherapy-sensitive patients, the objective response rate was 19% and the PFS was 2.8 months. And for the 12 chemotherapy resistant or relapsed patients, the objective response rate was 25% with a PFS of 1.4 months. When Puma licensed alisertib, we stated that one of the focuses was to try to reduce the adverse event profile of the drug, and more specifically, the Grade 3/4 neutropenia, by giving prophylactic G-CSF with the administration of alisertib. This is being instituted in the ALISCA-Lung1 and we look forward to seeing the results of this trial to better assess whether or not the prophylactic use of G-CSF improve the adverse event profile of the drug. We will also be looking at the efficacy of alisertib in the ALISCA-Lung1 trial. And more specifically, we will be looking at response rate and PFS both by type of relapse after treatment, sensitive versus resistant refractory and by small cell lung cancer molecular subtype ASCL1, NEUROD1, POU2, F3 and YAP1. As mentioned previously, we will be – also be performing a biomarker analysis on the patients in the ALISCA-Lung1 study in order to see if the efficacy of alisertib monotherapy in patients with small cell lung cancer correlates with biomarkers where the aurora kinase pathway plays a role. There are currently 12 patients enrolled in the ALISCA-Lung1 trial, with several in screening and pre-screening. We anticipate that we will be able to share interim data from this trial with investors in late 2024 in addition to two clinical presentations of alisertib were made at the 2024 ASCO Annual Meeting in early June. Investors will remember that the Phase 2 trial referred to as TBCRC 41, which was a Phase 2 trial of alisertib monotherapy versus alisertib plus endocrine therapy in patients with HER2-negative hormone receptor positive metastatic breast cancer, which was published in JAMA Oncology in 2023. As part of this trial, an analysis of biomarkers was performed in order to determine if the efficacy of alisertib in patients with HER2-negative hormone receptor positive metastatic breast cancer correlates with any biomarkers. Some of the biomarker data from this trial was presented on a poster at the 2024 ASCO Annual Meeting. We anticipate the initiation of the ALISCA-Breast1 study, a Phase 2 trial of alisertib in combination with endocrine treatment in patients with chemotherapy-naïve HER2-negative hormone receptor positive metastatic breast cancer in q4 of 2024. In addition, there is an ongoing investigator-sponsored trial of alisertib given in combination with osimertinib in patients with metastatic EGFR mutant non-small cell lung cancer. More specifically, patients with metastatic EGFR mutant non-small cell lung cancer are treated with osimertinib, and then at the time of progression, alisertib is added to osimertinib in order to see if alisertib can overcome osimertinib resistance. Interim data on this trial was previously presented at ASCO prior to Puma licensing this drug. Updated data from this trial was presented as a poster presentation at the 2024 ASCO Annual Meeting. For the 21 evaluable patients, the investigator assessed overall response rate was 9.5% and the disease control rate was 81%. The median PFS for all patients was 5.5 months, while the median OS was 23.5 months. For patients with TP53 mutations, (n=9), the overall response rate was 0% and the disease control rate was 66.7%. For the patients who were TP53 wild type, which was 8 patients, the overall response rate was 25%, and the disease control rate was 87.5%. For patients with TP53 mutations, progression-free survival was 3.7 months, and for patients who are tp53 wild type, the progression-fee survival was 8 months. The hazard ratio for PFS was 0.42 with a p-value of 0.05. Based on these interim results, the trial has been amended such that it will limit future enrollment in the trial to patients who are TP53 wild type. We look forward to updating investors on this data in the future. As previously 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 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 out by reiterating our strategy. The commercial team remains largely focused on the extended adjuvant indication where the majority of NERLYNX sales and opportunity exists. Our commercial messaging is focused on HER2-positive patients that are deemed to be at higher risk of reoccurrence. A significant portion of these early-stage breast cancer patients are treated in the community oncology setting, and are being seen across a large number of community oncologists. Given this distribution of patients, our sales and marketing teams are focused on efficiently increasing reach and frequency for both personal and non-personal promotion with an emphasis on trying to reach customers when decisions are being made for the extended adjuvant setting. HCP calls in the second quarter increased about 6% quarter-over-quarter, but declined about 8% year-over-year. The year-over-year decline was driven by the timing of vacancies. In the second quarter, greater than 80% of calls were live interactions. We are continuing to evaluate new data and vendor partners that would allow us to operate more efficiently and effectively with the goal of balancing the needs of NERLYNX with the goals of the broader organization. Let me transition now into some of the commercial slides where I will provide some additional specifics around performance. Once I am finished, I will turn the call over to Maximo for a more detailed review of our financial results. Slide 3 provides an overview of our distribution model. This model has not changed and remains separated into two distinct channels, the specialty pharmacy channel and the specialty distributor channel or in-office dispensing channel. We do typically see quarterly fluctuations, but the majority of our business flows through the specialty pharmacy channel. In Q2, about 72% of our business went through the specialty pharmacy channel and the remaining 28% went through the specialty distributor channel. As a comparison, in Q1, we reported about 74% of our business going through the specialty pharmacy channel and the remaining 26% of our business going through the specialty distributor channel. Turning to Slide 4. NERLYNX net revenue in Q2 was $44.4 million, which is a $4.1 million increase from the $40.3 million we reported in Q1 of ‘24, and a $7.2 million decrease from the $51.6 million we reported in Q2 of 2023. Inventory changes will impact these comparisons, so let me provide some additional information. In Q2 of 2024, we estimate that inventory decreased by about $2.3 million. As a comparison, we estimate that inventory decreased by about $2 million in Q1 and decreased by about $1.5 million in Q2 of 2023. Slide 5 shows Q2 ‘24 ex-factory bottle sales, and also provides both a year-over-year and a quarter-over-quarter comparison. In Q2 of ‘24, NERLYNX ex-factory bottle sales were 2,515, which represents a 4% quarter-over-quarter increase and a 17% year-over-year decline. Let me again provide more specifics around inventory changes. We estimate that inventory decreased by about 132 bottles in the second quarter of 2024. As a comparison, we estimate that inventory decreased by about 121 bottles in Q1 of ‘24 and decreased by about 90 bottles in Q2 of ‘23. Now let me share some additional metrics and insight into our second quarter performance. In Q2, we saw new patient starts or NRx decreased by about 9% quarter-over-quarter and declined about 10% year-over-year. In terms of total prescriptions, or TRx, we saw a 3% increase quarter-over-quarter and a 14% decline year-over-year. Overall demand increased in the second quarter by about 5% quarter-over-quarter and declined about 15% year-over-year. Q2 performance was negatively impacted by the decline in enrollments we discussed in our Q3 and Q4 earnings call. As a reminder, we saw increased softness in enrollments that largely occurred in the first part of Q3 last year. Enrollments are obviously an important leading indicator as enrollments turn into new patient starts and new patient starts turn into refills, which impacts demand in subsequent quarters. In Q2, enrollments decreased about 5% quarter-over-quarter and about 11% year-over-year. The second quarter-over-quarter decline follows the typical pattern we see with enrollments growing in Q1 quarter-over-quarter, which we saw this year, but then declining quarter-over-quarter in Q2. As a reminder, this pattern occurs as some patients delay starting therapy in the fourth quarter to avoid side effects around the holidays. This pattern decreases enrollments in the fourth quarter, but subsequently increases enrollments in the first quarter. Enrollments remain a top priority and the team is focused on improving the year-over-year enrollment comparisons. Turning to Slide 6. Slide 6 highlights the quarterly adoption of dose escalation since NERLYNX launch. In Q2, approximately two-thirds of patients started NERLYNX at a reduced dose. This is similar to what we reported in Q1 of this year. The benefits of utilizing dose escalation to initiate therapy with NERLYNX, continues to be an important part of our commercial messaging. The control trial showed a significant reduction in grade 3 diarrhea, and improved persistence and compliance when patients were started at a lower dose. We track multiple cohorts of patients, and do see improved compliance when patients have started using dose escalation. Slide 7 highlights the strategic collaborations we have formed across the globe. In Q2, NERLYNX received regulatory approval in Brazil in the metastatic setting, and regulatory approval in Saudi Arabia in the extended adjuvant setting. In addition, NERLYNX was just recently launched in South Africa, also in the extended adjuvant setting. We truly appreciate the work being done by our partners and look forward to supporting their continued success moving forward. I’d like to wrap up by thanking my Puma colleagues for their dedication. The team remains passionate about making a difference in the lives of patients and their families battling cancer. We are committed to being more efficient and effective with the resources and also committed to balancing the short-term and long-term priorities of Puma and its shareholders. I will now turn the call over to Maximo for a review of our financial results. Maximo?

Maximo Nougues: Thanks, Jeff. I will begin with a brief summary of our financial results for the second quarter of 2024. Please note that I will make comparisons to Q1 2024, which we believe is 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 Q2 10-Q, which will be filed today and includes our consolidated financial statements. For the second quarter of 2024, we reported a net loss based on GAAP of $4.5 million or $0.09 per share. This compares to a net loss in Q1 2024 of $4.8 million or $0.10 per share. On a non-GAAP basis, which is adjusted to remove the impact of stock-based compensation expense, we reported a net loss of $2.5 million or $0.05 per share for the second quarter of 2024. Gross revenue from NERLYNX sales was $55.8 million in Q2 2024 and $52.6 million in Q1 2024. As Alan mentioned, net product revenue from NERLYNX sales was $44.4 million, an improvement from the $40.3 million reported in Q1 2024. Higher demand and lower gross net adjustments drove the higher sales versus Q1 2024. Inventory drawdown by our distributors was approximately $2.3 million in Q2 versus approximately $2 million of drawdown in Q1 2024. Royalty revenue totaled at $2.7 million in the second quarter of 2024 compared to $3.5 million in Q1 2024. Our gross net adjustment in Q2 2024 was about 20.4% compared to the 23.4% gross net adjustment reported in Q1 2024. Lower Medicaid share, coverage gap and lower co-pay were the main drivers of the decline versus Q1 2024. Cost of sales for Q2 2024 was $10.7 million, including $2.4 million for the amortization of intangible assets related to our neratinib license. Cost of sales for Q1 2024 was also $10.7 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 2024, Puma continues to anticipate that net NERLYNX product revenue will be in the range of $183 million to $190 million. We also anticipate that our gross to net adjustment for the full year 2024 will be between 21% and 22%, higher than 2023 due to the impact of the Inflation Reduction Act and higher expected Medicaid rebates. In addition, for the fiscal year 2024, we anticipate receiving royalties from our partners around the world in the range of $30 million to $33 million. We expect license revenue in 2024 in the range of $1 million to $2 million. We also expect that net income for the full year will be in the range of $12 million to $15 million. We anticipate that for Q3 2024, NERLYNX mix product revenue will be in the range of $50 million to $53 million. Please note that the Q3 net product revenue guidance includes almost $6 million of product sales to one of our global partners as well as U.S. net revenue, which we expect to be in the range of $44 million to $47 million. The sales to our global partners will also contribute to the large royalty revenue that we expect in Q3. We expect Q3 royalty revenues will be in the range of $20 million to $22 million, and we anticipate no license revenue. We further estimate that the gross to net adjustment in Q3 2024 will be approximately 18.5% to 19.5%. Puma anticipates Q3 net income between $11 million and $13 million. We anticipate that Puma will be net income positive for the full year. SG&A expenses were $25 million in the second quarter of 2024 compared to $21.8 million for the first quarter of 2024. SG&A expenses included non-cash charges for stock-based compensation of $1.4 million for Q2 2024, down from $1.5 million in Q1 2024. Research and development expenses were $13.6 million in the second quarter of 2024, unchanged from the first quarter of 2024. R&D expenses included non-cash charges for stock-based compensation of $0.6 million in the second quarter of 2024, down from $0.9 million for the first quarter of 2024. On the expense side, Puma continues to anticipate flat total operating expenses in 2024 compared to 2023. More specifically, we anticipate SG&A expenses to decrease by 8% to 12% and R&D expenses to increase by 16% to 19% year-over-year. In the second quarter of 2024, Puma reported cash burn of approximately $10.3 million. This compares to cash earned of approximately $11.2 million in Q1 2024. Please note that during Q2, we made our first principal loan payment of $11.1 million related to our obligation with Athyrium. As a result of this, our total outstanding principal debt balance decreased from $100 million to approximately $89 million. At June 30, 2024, we had approximately $96.8 million in cash, cash equivalents and marketable securities versus about $96 million at year-end 2023. Our accounts receivable balance was $28.1 million. Our accounts receivable terms range between 10 and 68 days, while our days sales outstandings are 46 days. We estimate that as of June 30, 2024, our distribution network maintained approximately 3 weeks of inventory. Overall, we continue to deploy our financial resources to focus on the commercialization of NERLYNX, the development of alisertib and controlling our expenses.

Alan Auerbach: Thanks, Maximo. Puma’s senior management, in cooperation with Board of Directors, continues to remain focused on NERLYNX sales trends in 2024 and beyond, and recognizes its fiscal responsibility to shareholders to continue to maintain positive net income. 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 the positive net income that was seen in 2023 resulted from these expense reductions. The expense reductions that we have previously performed and continue to perform are also a major contributor to the positive net income that the company is guiding forward for full year 2024. The company remains committed to continuing to achieve this positive net income, and will continue to reduce expenses if needed to achieve this in the future. 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?

Operator: [Operator Instructions] Your first question comes from Marc Frahm with TD Cowen. Please proceed with your question.

Marc Frahm: Thanks for taking my questions. Maybe just on the planned disclosure around ALISCA1 in Q4 or late in the year. I mean, can you just walk through – and thanks for the granularity that we don’t often see on patient enrollment heading into it. But 9 is not a ton of patients, and maybe response data on just 9 patients wouldn’t be the most meaningful. I know you intend to have a few more. How kind of rigid is that timeline to presenting data no matter what in Q4 versus is it really in your head a number of patients that you want to get to, and if – and you’re hoping that’s Q4, but if it happens to be Q1, you’d get – you’d push it out? That’s one question. And then the other is just, can you just run through the latest on some of these subsets based on the genetic background, just so what do we know about the outcomes for those patients on kind standard of care, and therefore how to comp your data when you do show it for those subsets?

Alan Auerbach: Yes, Mark, thanks for the question. So first of all, Mark, there’s 12 patients currently enrolled, not 9.

Marc Frahm: Sorry, 12.

Alan Auerbach: 12, yes. And then several are in screening. So look, it’s August. So if we present the data, let’s say, in December, obviously, more time to get more patients too, right? So, will it be 12, will be 15, don’t know. I would rather be a good steward of shareholder capital and present data even if early just so that people know what’s happening rather than kind of just delay it till we get to some magic number or something. We obviously have the two things we’re looking at. We have the safety aspect of it and the efficacy aspect of it. As you’ll remember, in the trial that was done and published in the Journal of Thoracic Oncology, which was the paclitaxel plus alisertib against paclitaxel-placebo, we would anticipate that would be our future randomized trial for full approval. In that study, from the safety perspective, I don’t have the numbers in front of me, but it’s like – early in the study, it was like 30% of the patients couldn’t tolerate the paclitaxel plus alisertib combination due to neutropenia. So that obviously compromised that arm. So clearly, using the prophylactic G-CSF, if we can reduce the neutropenia and improve the tolerability, I would obviously think that would portend for a more favorable future randomized trial there as well. In terms of the efficacy side of it, so we mentioned the previous data in Lancet Oncology. The main difference between those patients and the ones we’re testing now is, at the time the Lancet Oncology study was going on, I/O had not really been incorporated in the standard of care. So I don’t think any of those patients have seen prior I/O. All of our patients will have seen that because now that’s standard of care. Does that change anything? I don’t know why it would, but that’s why you do these studies, obviously. Now in terms of the various biomarkers and subgroups, et cetera, I mentioned a lot of the genetic subgroups. I don’t know from a regulatory perspective how much those will play a role. So that would be a future discussion with FDA. In terms of the biomarkers that we are involved in the aurora kinase pathway such as c-Myc, such as RB1 loss and things like that, if you go and look at the randomized study, which was the study of the Journal of Thoracic Oncology paclitaxel-alisertib against paclitaxel alone, the patients who had those biomarkers, whether it was a c-Myc amplification or a RB1 loss of function mutation, my recollection is those tended to do worse than the ITT (NYSE:) group. So that should – I would perceive select for a higher risk group patients.

Marc Frahm: Okay. Thank you.

Alan Auerbach: Sure.

Operator: Thank you. And this concludes our question-and-answer session. I would like to turn the conference back to Mariann for closing remarks. Actually, one moment, one question just came up. My apologies. We do have one that just came up. And that question comes from Ed White with H.C. Wainwright. Please proceed with your question.

Ed White: Hi, thanks for taking my questions. Just a question on sales in the U.S. Guidance was given for NERLYNX sales on the first quarter results conference call. It was changed during the year – during the quarter. And then you just reported numbers to actually hit the original numbers. So I’m just wondering what was changing within the quarter that had to change your guidance? And then the second question is just on the royalty number. You’re having a huge bolus of revenues expected for royalties in the third quarter. I’m just wondering what’s the reasons behind that? Thank you.

Alan Auerbach: Hi, Ed, it’s Alan. On your first comment, we didn’t change our Q1 revenue guidance for NERLYNX. Can you clarify that? We have no – we’re all looking at each other very puzzled here around the table. We never changed our guidance. So can you clarify that?

Ed White: I’m sorry. I had that you had original guidance that you gave in the first quarter for the second quarter of $43 million to $45 million for the second quarter. And then during the quarter in a PowerPoint presentation that you had on your website, the guidance was changed to $38 million to $40 million, unless I’m mistaken and maybe I was looking at an older presentation.

Alan Auerbach: Yes. We never changed this.

Ed White: Okay. Thanks, Alan. That’s my mistake, and I apologize.

Alan Auerbach: We checked the website. I don’t have any – I apologize, Ed. I’m not – I was not aware there was a presentation put at the website doing that. If it was, it was an error. We never changed the Q2 revenue number. There was no revenue guidance change. So I apologize if, for some reason, that happened. We will check on that error. It was never – it may have been some older presentation or something that somehow got linked somewhere or something, but we never changed our Q2 revenue, U.S. NERLYNX revenue guidance. Any Q2 guidance was never changed from what we put out on our Q1 earnings call.

Ed White: Okay. Thanks, Alan, for the clarification…

Alan Auerbach: No, it’s my apologies for the confusion. I wish I was aware of that earlier. I didn’t know that. So again, we’ll check on that. We’ll get back to you. Thank you for bringing it to our attention. On the second one, which is the bolus in the royalties, for all of our – the various regions, we get our royalties at – basically as they’re sold, if you will. So it’s kind of direct. The one outlier is in China, which is that we get our sales kind of when they’re sold into the channel. And so that’s what gets this lumpiness. So kind of if you look at our historical royalties, you’ll always see like once a year or so, this big bolus and that’s usually just one big shipment into China. So it’s not based on end-user demand, it’s more based on sales into the channel. So, we get this lumpiness. It happens once a year. I realize it creates some confusion, but that’s the nature of the way the agreement is set up.

Ed White: Okay, Alan.

Alan Auerbach: Thank you.

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

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

Operator: 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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