Puma Biotechnology - Q2 2024

Transcript

Operator (participant)

My name is Diego, and I will be your conference call operator today. At this time, all participants are in a listen-only mode. After the speaker's formal remarks, there will be a question-and-answer session. If you would like to ask a question during that time, simply press the star key, then the number one on your telephone keypad. If you would like to withdraw your questions, please press star two. If you should require operator assistance during the conference, please press star zero. As a reminder, this conference is being recorded. I would now like to turn the call over to Mariann Ohanesian, Senior Director of IR for Puma Biotechnology. You may begin your conference.

Mariann Ohanesian (Senior Director of Investor Relations)

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 close 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 investor 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 may be 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 (CEO, President, and Chairman of the Board)

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 at 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's 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 was 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 trial, and we look forward to seeing the results of this trial to better assess whether or not the prophylactic use of G-CSF improved the adverse event profile of the drug. We'll also be looking at the efficacy of alisertib in the ALISCA-Lung1 trial, and more specifically, we'll 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, POU2F3, and YAP1.

As mentioned previously, we will also be performing a biomarker analysis on the patients in the Alisertib-Lung-1 study in order to see if the efficacy of alisertib monotherapy in patients with small cell lung cancer correlates with biomarkers with aurora kinase pathway plays a role. There are currently 12 patients enrolled in the Alisertib-Lung-1 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, two clinical presentations on alisertib were made at the 2024 ASCO annual meeting in early June. Investors will remember that the phase two trial referred to as TBCRC41, which was a phase two 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 Alisertib-Breast-1 study, a phase II trial of Alisertib in combination with endocrine treatment in patients with chemotherapy-naive, 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 were TP53 wild type, the progression-free 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 (Chief Commercial Officer)

Thanks, Alan. Appreciate it. 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 exist. Our commercial messaging is focused on HER2-positive patients that are deemed to be at higher risk of recurrence. 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 have 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 a remaining 26% of our business going through the specialty distributor channel. Turning to slide four, NERLYNX's 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 2024, 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 2024 ex-factory bottle sales and also provides both a year-over-year and a quarter-over-quarter comparison. In Q2 of 2024, 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 2024 and decreased by about 90 bottles in Q2 of 2023.

Now, let me share some additional metrics and insights into our second quarter performance. In Q2, we saw new patient starts or NRX decrease by about 9% quarter-over-quarter and decline 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 turned into new patient starts, and new patient starts turned 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 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's 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 are 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 our 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 (CFO)

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 than year-over-year comparisons. For more information, I recommend that you refer to our Q2 10-Q, which we refiled 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 $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 copay 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 NERLYNX 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 at cost of sales. For fiscal year 2024, Puma continues to anticipate that net NERLYNX's product revenue will be in the range of $183 million-$190 million. We also anticipate that our gross-to-net adjustment for the full year 2024 will be between 21%-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-$33 million.

We expect license revenue in 2024 in the range of $1 million-$2 million. We also expect that net income for the full year will be in the range of $12 million-$15 million. We anticipate that for Q3 2024, NERLYNX net product revenue will be in the range of $50 million-$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-$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-$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%-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 from 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%-12% and R&D expenses to increase by 16%-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 day sales outstandings are 46 days.

We estimate that as of June 30, 2024, our distribution network maintained approximately three 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 (CEO, President, and Chairman of the Board)

Thanks, Maximo. Puma 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 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.

It 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 (participant)

We will now begin the question-and-answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. If you wish to withdraw your question, please press star two. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we pull for questions. Your first question comes from Marc Frahm with TD Cowen. Please proceed with your question.

Marc Frahm (Biotechnology Equity Research Analyst)

Hey, thanks for taking my question. Maybe just on the planned disclosure around alisertib in Q4 or late in the year. Alan, can you just walk through, thanks for the granularity that we don't often see on patient enrollment heading into it, but nine is not a ton of patients, and maybe response data on just nine 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 you're hoping that's Q4, but if it happens to be Q1, you'd push it out? That's one question. And then the other is just can you just run into the latest on some of these subsets based on the genetic background?

Just what do we know about the outcomes for those patients on kind of standard of care and therefore how to comp your data when you do show it for those subsets?

Alan Auerbach (CEO, President, and Chairman of the Board)

Yeah, Marc, thanks for the question. So first of all, Marc, there's 12 patients currently enrolled, not nine.

Marc Frahm (Biotechnology Equity Research Analyst)

Or sorry, 12.

Alan Auerbach (CEO, President, and Chairman of the Board)

Yeah, 12. Yeah. And then several are in screening. And so look, it's August. So if we present the data, let's say, in December, obviously more time to get some more patients too, right? So will it be 12? Will it 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 + 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 remember this correctly, 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 pertain 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, IO had not really been incorporated into standard of care, so I don't think any of those patients had seen prior IO.

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, etc., 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 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 MYC amplification or an Rb1 loss of function mutation, my recollection is those tended to do worse than the ITT group. So that should, I would perceive, select for a higher risk group of patients.

Marc Frahm (Biotechnology Equity Research Analyst)

Okay. Thank you.

Alan Auerbach (CEO, President, and Chairman of the Board)

Sure.

Operator (participant)

Thank you. 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. That question comes from Ed White with H.C. Wainwright. Please state your question.

Ed White (Managing Director and Senior Biotechnology Analyst)

Hi. Thanks for taking my question. 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 that actually hit the original numbers. So I'm just wondering what was changing within the quarter that had you 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 (CEO, President, and Chairman of the Board)

Yeah. Hi, Ed. It's Alan. On your first comment, we didn't change our Q1 revenue guidance for NERLYNX. Can you clarify that? We're all looking at each other very puzzled here around a table. We never changed our guidance. So can you clarify that?

Ed White (Managing Director and Senior Biotechnology Analyst)

I'm sorry. I had that you had original guidance that you gave in the first quarter for the second quarter of $43 million-$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-$40 million, unless I'm mistaken, and maybe I was looking at an older presentation.

Alan Auerbach (CEO, President, and Chairman of the Board)

Yeah. We never changed it.

Ed White (Managing Director and Senior Biotechnology Analyst)

Okay. Thanks, Alan. That's my mistake. I apologize.

Alan Auerbach (CEO, President, and Chairman of the Board)

Can we check the website? I don't have any—I apologize for that. I was not aware there was a presentation put on our 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 may have been some older presentation or something that somehow got linked somewhere or something, but we never changed our Q2 revenue, NERLYNX's revenue guidance, or any Q2 guidance was never changed from what we put out on our Q1 earnings call.

Ed White (Managing Director and Senior Biotechnology Analyst)

Okay. Thanks, Alan, for the clarification.

Alan Auerbach (CEO, President, and Chairman of the Board)

Yeah. I know. I apologize. 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 the various regions, we get our royalties 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 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 (Managing Director and Senior Biotechnology Analyst)

Okay. Thanks, Alan.

Alan Auerbach (CEO, President, and Chairman of the Board)

Sure.

Operator (participant)

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

Mariann Ohanesian (Senior Director of Investor Relations)

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 (participant)

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.