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Exelixis Inc (EXEL) Q1 2021 Earnings Call Transcript

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EXEL earnings call for the period ending March 31, 2021.

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Exelixis Inc (EXEL 0.46%)
Q1 2021 Earnings Call
May 6, 2021, 5:00 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Good morning, ladies and gentlemen, and welcome to the Exelixis First Quarter 2021 Financial Results Conference Call. My name is Daphne, and I'll be your operator for today. As a reminder, this call is being recorded for replay purposes.

I would now like to turn the call over to your host for today, Ms. Susan Hubbard, Executive Vice President of Public Affairs and Investor Relations. Please proceed.

Susan T. Hubbard -- Executive Vice President, Public Affairs and Investor Relations

Thank you, Daphne, and thank you all for joining us for the Exelixis First Quarter 2021 Financial Results Conference Call. Joining me on today's call are Mike Morrissey, our President and CEO; Chris Senner, our Chief Financial Officer; P.J. Haley, our Executive Vice President of Commercial; and Gisela Schwab, our Chief Medical Officer, who together will review our corporate, financial, commercial and development progress for the first quarter 2021 ended March 31, 2021. Peter Lamb, our Chief Scientific Officer, is also here and will join us for the question-and-answer session following our prepared remarks.

During the call today, we will refer to financial measures not calculated according to generally accepted accounting principles. Please refer to today's press release, which is posted on our website for an explanation of our reasons for using such non-GAAP measures as well as tables deriving these measures from our GAAP results. During the course of this presentation, we will be making forward-looking statements regarding future events and the future performance of the company. This includes statements about possible developments regarding discovery, product development, regulatory, commercial, financial and strategic matters.

Actual events or results could, of course, differ materially. We refer you to the documents we file from time to time with the SEC, which under the heading Risk Factors, identify important factors that could cause actual results to differ materially from those expressed by the company verbally and in writing today, including without limitation, risks and uncertainties related to product commercial success, market competition, regulatory review and approval processes, conducting clinical trials, compliance with applicable regulatory requirements, our dependence on collaboration partners and the level of cost associated with discovery, product development, business development and commercialization activities.

And with that, I will turn the call over to Mike.

Michael M. Morrissey, Ph.D. -- President and Chief Executive Officer

All right. Thank you, Susan, and thanks to everyone for joining us on the call today. Exelixis started 2021 with a strong first quarter, where we saw a significant revenue growth from CaboNivo first-line RCC launch and posted our highest quarterly net product revenue since the initial CABOMETYX approval in 2016. Please see our press release that was issued an hour ago for our first quarter financial results and an extensive list of key corporate accomplishments. We'll keep today's prepared remarks short, so we can get to your important questions. Obviously, we're thrilled with the early performance of CaboNivo launch in first line RCC, which we believe reflects the strength and breadth of the efficacy, tolerability and quality of life data from the CheckMate 9ER trial.

We continue to build momentum with a combined 35% growth in revenue over the last two quarters and anticipate a near doubling of cabo RCC revenues by the end of 2022, when we expect to exit with a $1.5 billion annualized run rate in the U.S., if our launch assumptions and trajectory continue on its current course. Also in the first quarter, we advanced key 2021 discovery, development and regulatory activities. We remain on track to report top line results for the cabo/atezo doublet in first-line HCC from COSMIC-312 and in metastatic CRPC from COSMIC-021 Cohort six, and expect to file up to three new sNDAs for cabo across these indications, pending positive results, along with the filing for COSMIC-311.

Our early clinical pipeline also advanced nicely in the quarter with significant progress in the XL092 program, the initiation of the Phase I clinical trial of XL102, our novel CDK7 inhibitor, and the IND filing for XB002, which was accepted by the FDA in April. Our discovery and preclinical teams continue to make important progress toward the optimization and characterization of new development candidates for both small molecule and ADC programs, which we believe will provide the foundation for new clinical candidates in the near future.

I'll close here by saying that the Exelixis team has hit the ground running in 2021 and is building on the urgency and focus from our recent progress to maximize our chance for success across the range of milestones ahead of us. I'm incredibly proud to say that we're coming out of COVID stronger than ever as we drive our business forward to help cancer patients live longer and recover stronger.

So with that, I'll turn the call over to Chris, who will provide an update on our first quarter 2021 financial results. Chris?

Christopher J. Senner -- Executive Vice President and Chief Financial Officer

Thanks, Mike. For the first quarter 2021, the company reported total revenues of $270.2 million. Total revenues for the quarter included cabozantinib franchise net product revenues of $227.2 million. Net product revenues in the first quarter 2021 were impacted by higher demand for CABOMETYX and a decrease in wholesaler inventory. CABOMETYX wholesale inventory decreased by approximately 300 units, and when combined with the higher demand, resulted in a decrease in our inventory weeks on hand from approximately 3.1 weeks on hand in the fourth quarter 2020 to approximately 2.3 weeks on hand in the first quarter of 2021.

Total revenues also included $43 million in collaboration revenues from Ipsen, Takeda and Genentech. Our total operating expenses for the first quarter of 2021 were $274.8 million compared to $245.8 million in the fourth quarter of 2020. SG&A expense was the primary driver of the increase in total operating expenses, which was primarily employee-related expenses, including an increase in stock-based compensation expense. Also impacting our total operating expenses for the first quarter 2021 was approximately $24 million in-licensing upfront and milestone fees.

Benefit from income taxes for the first quarter of 2021 was $3.6 million compared to a benefit of $300,000 in the fourth quarter of 2020. The company reported GAAP net income of $1.6 million or $0.00 per share on a fully diluted basis for the first quarter of 2021. The company also reported non-GAAP net income of $28.5 million or $0.09 per share on a fully diluted basis. Non-GAAP net income excludes the impact of approximately $26.9 million of stock-based compensation expense net of the related income tax effect. Cash and investments for the quarter ended March 31, 2021, was approximately $1.6 billion. And finally, turning to our financial guidance for the full year 2021. We are maintaining the financial guidance that we provided earlier this year.

And with that, I'll turn the call over to P.J.

P.J. Haley -- Executive Vice President, Commercial

Thank you, Chris. Today, I will discuss the CABOMETYX business with regards to Q1 2021, particularly in the context of the first approval for CABOMETYX in combination with an immune checkpoint inhibitor. As you know, on January 22, CABOMETYX received FDA approval for use in first-line RCC in combination with nivolumab. The team was fully prepared to hit the ground sprinting, and we are pleased with the execution of the launch, which is resulting in rapid and importantly, broad uptake of CABOMETYX. CABOMETYX was the only TKI in Q1 among the CABOMETYX in Lida, Sutent and Votrient, or CISV, market basket to grow NRx market share, increasing from 32% in Q4 to 36%, according to IQVIA data.

Importantly, CABOMETYX NRx volume grew 31% Q1 2021 over Q4 2020, driven primarily by uptake of the combination of cabo and nivo in the first-line setting. Additionally, CABOMETYX TRx volume increased by 21% in Q1 relative to Q4 of 2020. We are also pleased adoption was broad across a number of key segments with strong uptake in favorable, intermediate and poor clinical risk groups as the 9ER data is resonating with physicians broadly as they think about patients who are appropriate for the regimen. Our market research shows that CABOMETYX in combination with nivo is taking share from all first-line competitors already at this early stage of the launch. Beyond these initial metrics, we won't be providing other details for competitive reasons, specifically market share by line of therapy, which I'm sure you can appreciate.

Uptake in the academic segment has been rapid, and we are seeing strong adoption in the community setting as well. We believe there is significant opportunity for continued growth in new patient market share, particularly in the community setting. Recently, we have begun to see many community accounts begin to reopen access to industry representatives, given improving trends in the pandemic. While this is variable depending on the account and geography, our belief is that this will continue to improve facilitation of education and discussions of the 9ER data, which prescribers find compelling and important for their patients with RCC who have yet to receive a therapy.

This trend, coupled with our comprehensive launch plan for execution of both virtual and in-person tactics, should continue to drive new patient market share in the community setting. In addition to the broad uptick of CABOMETYX plus nivo in the marketplace, perceptions of the 9ER data have been very positive. There has been a rapid increase in unaided awareness of the approval of this combination as well as favorable impressions of the efficacy of the combination based on the endpoints of OS, PFS and ORR across key subgroups, including IMDC risk categories. Importantly, the safety profile of the combination driven by the optimized cabo combination starting dose of 40 milligrams daily is viewed favorably by prescribers.

It is improving the overall perceptions of safety and tolerability of CABOMETYX. Physicians also view the quality of life benefit demonstrated in 9ER is differentiating and important for their patients who may be on first-line therapy for extended lengths of time. The Exelixis team is continuing strong and focused execution on the launch. These efforts are aided by the recently published cabozantinib data at ASCO GU, including a presentation focused on quality of life. Furthermore, the publication of 9ER in the New England Journal of Medicine on March three and the recent update of the NCCN guidelines on April 21, which positioned cabozantinib plus nivolumab as the only FDA approved, preferred Category one regimen across all clinical risk groups should continue to support the broad uptake of the combination.

The strong Q1 performance in CABOMETYX launch trajectory position the cabozantinib franchise to continue significant revenue growth in 2021 and beyond. We're thrilled with the opportunity that 9ER provides Exelixis looking forward as we continue to build upon the foundation in RCC where CABOMETYX is the number one prescribed TKI. Beyond 9ER, we -- excuse me, we're already working on plans to optimize potential future access of the cabozantinib development program that moves forward broadly across multiple indications and with different combination partners.

We look forward to building on this momentum in RCC, HCC, DTC and other potential future indications, such as prostate and lung, as our development program evaluating cabo in combination with immune checkpoint inhibitors advances. Our team remains highly focused and motivated to compete every day to bring the benefit of CABOMETYX and to all eligible patients as we continue to build the franchise and maximize its clinical and commercial potential.

And with that, I will turn the call over to Gisela.

Gisela M. Schwab, M.D. -- President, Product Development and Medical Affairs and Chief Medical Officer

Thank you, P.J. I'm pleased to provide an update on the development programs. 2021 is certainly off to a great start for our cabozantinib regulatory and development program as well as for our growing clinical pipeline programs, including XL092, XL102 and XB002. Starting with the cabozantinib regulatory progress. After our January 2021 approval by FDA for the cabozantinib and nivolumab combination for the first-line treatment of patients with advanced RCC. the combination achieved a positive CHMP opinion in the EU in February. And quickly thereafter, in late March, the European Commission approved the combination for the first-line treatment of RCC patients in the EU.

After having reported exciting presentations in advanced RCC at ASCO GU for cabozantinib in combination with nivolumab from CheckMate 9ER as well as single agent cabozantinib results, including from the prep-phase study, we are now looking forward to the upcoming ASCO conference with further data presentations based on the CheckMate 9ER study and also single-agent results from COSMIC-311, our Phase III trial in differentiated thyroid cancer. Turning to an update on our ongoing program for cabozantinib. We have continued our execution of the COSMIC-021, 311, 312 and 313 studies, and are on track for milestones on these trials, as previously shared, including three potential new cabozantinib sNDA filings.

I'll provide a brief summary on key highlights for the program. For COSMIC-311 in radio iodine refractory DTC patients who have received prior VEGFR targeted therapy, we are working toward an sNDA submission based on the strong results in a patient population with unmet medical need. As announced previously, the trial met its primary endpoint of progression-free survival with cabozantinib highly significantly improving progression-free survival versus placebo and FDA granted a breakthrough therapy designation for the indication during the quarter. Based on these results, we are focused on an sNDA filing that we expect to complete in the second quarter. COSMIC-312, our Phase III trial of cabozantinib plus atezolizumab versus sorafenib for the first-line treatment of advanced HCC completed accrual in the global study in mid-2020.

And we anticipate top line results of the event-driven PFS analysis and the concurrent interim analysis for overall survival in the second quarter of 2021. And if warranted by the data and results, we are expecting to file an sNDA in the fourth quarter of 2021. For COSMIC-021, we look forward to the final analysis for objective response rate by the independent radiology committee of Cohort six in metastatic CRPC in mid-2021 and a plan for regulatory submission of the results data providing. And lastly, for COSMIC-313, comparing the triplet of cabozantinib and nivolumab and ipilimumab versus nivolumab and ipilimumab in first-line RCC patients with intermediate or poor risk per IMDC, we completed a patient enrollment in late March.

And we are now looking forward to top line results of the event-driven analysis for the study in 2022. For the ongoing contact Phase III program under our collaboration with Roche, we are actively enrolling patients globally across all three Phase III trials in checkpoint inhibitor pretreated non-small cell lung cancer in RCC patients and in novel hormonotherapy pretreated CRPC patients. So in summary, the cabozantinib program continues to make significant progress, and we remain on track for data readouts in the next couple of months, as well as data providing potential supplemental NDA filings.

I'll now turn to the progress on our XL092 program and our new IND of Phase I programs for XL102 and XB002. First, XL092. Our next-generation MET, AXL, MER and VEGFR tyrosine kinase inhibitor with a shorter pharmacokinetic half-life is advancing in Phase I and we are in the midst of evaluating the combination with atezolizumab in a parallel Phase Ib part of the study. Importantly, we have recently entered into a clinical collaboration agreement with Merck KGAA, under which we will evaluate XL092 in combination with avelumab in various urothelial cancer cohorts including in the maintenance setting of the prior first-line platinum-containing chemotherapy as well as in the second-line setting in patients who have failed prior checkpoint inhibitor-containing therapy.

And further, we are actively discussing additional combination approaches with various checkpoint inhibitors and agents targeting novel mechanisms, preclinically and clinically, to continue to define opportunities for this important development program. We have a deep and solid foundation in tyrosine kinase inhibitors and extensive experience with cabozantinib and see many opportunities to build on and expand on the therapeutic settings as we plan for potential tumor indications and lines of therapy for XL092 combinations. Given this extensive experience, we view the XL092 development risk profile as potentially being greatly improved versus more typical early stage programs. So with that, we are driving our XL092 development plan forward.

That includes a broad and comprehensive program across various tumor indications, lines of therapy and settings of broad therapeutic interest. We intend to pursue the comprehensive evaluation of XL092 in combination with various established checkpoint inhibitors and potential new combinations, including promising new checkpoint inhibitor tablets as well as other combination partners. With the goal to potentially start late-stage pivotal trials as soon as 2021, we are focusing on advancing our Phase Ib dose-ranging in combination of our checkpoint inhibitors rapidly to move into expansion cohorts that may support data-driven, late-stage development options across a variety of tumor types. And secondly, we are excited to report progress with our latest IND candidates in 2021. For XL102, our oral CDK7 inhibitor, we have already started the Phase I trial and the cohort dose escalation phase is ongoing.

And also, we have recently announced the FDA's acceptance of the XB002 IND for our first biologic product candidate. XB002, an antibody drug conjugate or ADC targeting tissue factor has been rationally designed such that the binding site of the antibody does not interfere with the coagulation cascade. Based on this design and the available preclinical profile, we believe that XB002 may have the potential for a best-in-class ADC, targeting tissue factor. We're looking forward to progress on the Phase I studies for both compounds. The trials have been designed as efficient dose escalation trials with disease-specific expansion cohorts to allow for early assessment of initial antitumor activity. And I look forward to updating you on progress on our clinical pipeline in the future.

And with that, I'll hand the call back to Mike.

Michael M. Morrissey, Ph.D. -- President and Chief Executive Officer

All right. Thanks, Gisela. As you heard on the call today, we're off to a great start in 2021. Just last week, we marked the fifth anniversary of the first regulatory approval and launch of CABOMETYX in the U.S. That milestone-based on best-in-class data for cabo in the Phase III media trial in second-line RCC set Exelixis on the path to becoming the company it is today. Over the last five years, we've expanded the opportunity for cabozantinib to treat patients with thyroid, renal and liver cancer and have helped tens of thousands of patients in the U.S. in a similar number globally with our partners, Ipsen and Takeda. We're so excited about potential of our work, including the ongoing cabozantinib pivotal trials, the growing clinical development program for XL092 and our diverse and rapidly maturing early stage pipeline as we advance in our mission to help cancer patients live longer and recover stronger.

I'll close today by thanking everyone at Exelixis for their efforts in the first quarter and their individual and collective commitment, dedication and resilience under what were obviously extremely challenging conditions during COVID. As I mentioned in my intro, we're exiting a global pandemic stronger than when it started 14 months ago, and that's a true testament to the quality of the people we have working day in and day out as we discover, develop and commercialize the next generation of our medicines for cancer patients in need of better and more effective therapies. We look forward to updating you on our progress in the future, and thank you for your continued support and interest in Exelixis.

We're happy to now open the call for questions. And Daphne, please proceed.

Questions and Answers:

Operator

[Operator Instructions] Your first question comes from the line of Asthika Goodewarne with Truist Securities.

Asthika Goodewarne -- Truist Securities -- Analyst

Congrats on the quarter and the strong cabo rebound that we saw. P.J., I was wondering -- I know you don't want to give too much detail, but I was wondering if you could maybe share with us which of the first-line competitors you feel like CaboNivo maybe gain more share than some of the others. And then I got a couple of questions for Gisela.

P.J. Haley -- Executive Vice President, Commercial

Yes. Thanks for the question, Asthika. And we're extremely pleased with the beginnings of the launch. What I guess I'll say is, we're, as I mentioned in my prepared remarks, extremely pleased with the rapid broad uptake across not only competitive segments, but clinical risk categories favorable, intermediate, poor, academic and community. So I won't go into a lot more detail with respect to that in the numbers. But what I will say is as we look at the quarter, we were approved, as I mentioned here in late January.

So we basically had two full months on the market, February and March. And if we look at our new patient market share in those two months, we're very pleased that we see a market share in the mid-teens at that point and vectoring in a good direction, exiting the quarter. So we're very pleased with that.

Asthika Goodewarne -- Truist Securities -- Analyst

Great. Gisela, I was thinking about this. Tisotumab vedotin is already in the clinic for some of the tumor types that you have outlined in your plan for XB002, but not all of them. Could you tell us based on tissue factor expression and the higher dosing that you can push with XB002, where do you think you might have an edge over tisotumab?

Gisela M. Schwab, M.D. -- President, Product Development and Medical Affairs and Chief Medical Officer

Sure. Thank you for the question. And I think, as I mentioned, we see opportunity for XB002 and its rational design, and that the antibody does not bind in a way that it would interfere with the coagulation cascade, which should hopefully, trends defer into a favorable safety profile. Number one. Number two, tissue factor is pretty broadly expressed. And we intend to evaluate the compound across a variety of tumor types, assessing, of course, expression profiles in the patient population. And drive the program forward accordingly as we collect clinical data. So I think we have a broad opportunity and intend to pursue it aggressively.

Michael M. Morrissey, Ph.D. -- President and Chief Executive Officer

Asthika, maybe Peter could provide some color commentary here, too.

Peter Lamb, Ph.D. -- Executive Vice President, Scientific Strategy and Chief Scientific Officer

Yes. Just to add on to what Gisela said, in addition to the novel epitope for the antibody, which has the advantage she outlined. It does contain a kind of next-generation warhead link or construct, which we believe have some advantages over the first-generation constructs. This is one that Zymeworks has advanced and developed. And then from an expression point of view, as Gisela said, tissue factor is fairly broadly expressed. Obviously, we have clinical proof-of-concept or there is clinical proof-of-concept with cervical cancer. But beyond that, we actually presented -- or Iconic presented preclinical data late last year in pancreatic, I think, head and neck, gastric cancer, and there were several other solid tumors that we haven't explored preclinically yet. So the opportunity is broad.

Operator

Our next question comes from the line of Jason Gerberry with Bank of America.

Jason Gerberry -- Bank of America -- Analyst

One, just a housekeeping. So when you do update COSMIC-312, I'm wondering if we're actually going to get hazard ratios like we did with the 9ER update. I believe with 9ER, there was an issue of materiality and a need to disclose that because it was so important to the business, whereas I wonder with HCC, if that's the same situation. And then second question, just on the second Paragraph IV challenge to cabo from Teva.

It looks like they're certifying on some of the later expiring patents, some on formulation and methods used. These aren't patents that are being disputed in the MSN case. So just wondering if the reason why is because you chose not to enforce those patents? Or -- and the reason I ask is, it seems like more IP is getting added to the MSN case. And so just wondering, because it seems like the Street is assuming that this product is going to go off of a cliff in 2026.

Michael M. Morrissey, Ph.D. -- President and Chief Executive Officer

Yes. Thanks for the questions. It's Mike. I'll try to address both of them. So on the first question about the COSMIC-312 data press release when that finally hits top line results. Again, we -- our practice is to normally put in some level of data. And I wouldn't want to speculate on what that would be today. But some level of data to provide a framework for the relative activity because it's so material to us. I would argue that 312 is probably as important as 9ER is relative to the size of that market and the opportunity there in terms of a relatively nascent opportunity compared to where renal is currently.

So we'll certainly, I think, continue that practice with the details will be defined when we get that data. And understand what we've got. Okay. In terms of the second ANDA from Teva, I think you covered all the facts pretty well. So again, as we mentioned in our filings and our press release, that second ANDA came in recently, the Paragraph IV letter. Again, they're only challenging three orange book listed patents that expire in 2031 or later. So this is relatively new news to us. So I certainly wouldn't want to speculate on what they're thinking and what they're doing or how we're thinking about it ourselves or how we might proceed. It's something that we're certainly not surprised by in any shape, manner or form.

As we've said before, we expect these types of challenges to come in when you've got great compounds with great data and certainly growing revenues. And we have strong data, strong IP, and a really great team who are pursuing this very, very aggressively, and we have every intention to continue to defend our patent estate vigorously through all the legal challenge -- channels that we've got, and we will provide updates as necessary.

Operator

Your next question comes from the line of Akash Tewari with Wolfe Research.

Amy Lee -- Wolfe Research -- Analyst

This is Amy Lee on for Akash. So the first question on RCC. It seems like your current guide is baking in around 13 months of durability on treatment. Do you see any sort of upside to this number? Could TFS get better with longer follow-up? And how will COSMIC-313 impact this? And then I have another on in HCC.

P.J. Haley -- Executive Vice President, Commercial

Yes. Amy, this is P.J. Thanks for the question. I won't comment specifically on how we are thinking about modeling duration. But I think if you look at the PFS in the study, certainly very strong in patients in these clinical studies of the combinations and certainly the 9ER study are on therapy for 1.5 years or potentially longer. And I think it's important to remember that the data as these studies mature and get presented, sometimes the -- if not the median duration, the mean or average durations continue to increase over time.

But I'll kind of leave it at that. But we're certainly very optimistic about the opportunity for revenue growth, as I mentioned in my prepared remarks, and I think it's the early days for us in the launch. So certainly look forward to getting more and more patients on the regimen and then refills -- reflecting patients benefiting from that for some time to come.

Amy Lee -- Wolfe Research -- Analyst

Great. And then on HCC given that we're not seeing much of a differentiation on safety and efficacy with the early cabo and nivo combo data from CheckMate-040, what's the internal expectation on how COSMIC-312 will stack up against IMbrave or LEAP-002? And what would you consider as competitive data internally?

Michael M. Morrissey, Ph.D. -- President and Chief Executive Officer

Yes. It's Mike. Thanks for the question. I think it's really challenging to do any kind of cross-trial comparisons between a global pivotal trial run with two different molecules compared to what we had with 040, which had a doublet and a triplet that were different from IMbrave. Not only that was the -- it was smaller. It was really non-randomized with control, had a mix of first and second line patients. So I wouldn't draw the same conclusions you are around how similar that data might be for all kinds of reasons. So look, we're very excited about the opportunity.

Certainly, when you look at how we designed and enrolled 312 relative to IMbrave, populations are very similar. Obviously, atezo is the same in both. They're relatively contemporaneous trials, a lot of similar sites and investigators. The only difference is cabo versus bevacizumab, and you can look at the single-agent activity for those two agents across various tumor types and I think come to your own conclusions about how cabo might fare out there relative to bev. So end of the day, you've got to run the trial and get the data and look at the p-values and the hazard ratios, and we'll go off that to really judge our conclusions as we go forward.

Operator

Our next question comes from the line of Peter Lawson with Barclays.

Waleed Abdel-Naby -- Barclays -- Analyst

This is Waleed on for Peter. Just had a question on COSMIC-021. I know you're still waiting to do the analysis there. But when can we potentially see the data? And what are you looking for in that data set to sort of not only support approval but help you provide competitive offering in prostate cancer? And then I have a follow-up.

Michael M. Morrissey, Ph.D. -- President and Chief Executive Officer

Gisela, do you want to go ahead? Take that one?

Gisela M. Schwab, M.D. -- President, Product Development and Medical Affairs and Chief Medical Officer

Sure. Thank you. Thanks for the question. Yes. I think, regarding COSMIC-021, we are certainly very pleased with the progress made in the study. It's a large Phase Ib trial. It's been enrolling really well. We are excited about the data. And as we look at the data, we're seeing various cohorts mature very nicely, and we would expect to begin presenting results across various cohorts later this year and next. And so with regards to moving forward then in CRPC, like what here -- as I mentioned earlier in the call, we're looking to obtain the BRC, the independent radiology review for Cohort six in the next few weeks or a couple of months in the midyear time frame.

And as without telling, of course, earlier on as well, there's a lot going on in the next couple of months with the planned sNDA filing for COSMIC-311 and also the HCC top line readout in the second quarter as well. And this year, PC top line data for Cohort six being in the mix there as well. So certainly a lot of important milestones coming up, but we would expect to, of course, announce important data as we have them and obtain them. And that goes for this cohort as well. And then look forward to presenting data in scientific conferences and peer-reviewed journals as well.

Waleed Abdel-Naby -- Barclays -- Analyst

That's really helpful. And just on your XL092, when can we see data from the Phase Ib studies?

Gisela M. Schwab, M.D. -- President, Product Development and Medical Affairs and Chief Medical Officer

Yes. So XL092 is making good progress, as I mentioned earlier as well. The Phase I study and Phase Ib evaluation is moving along. In general, I think, as I mentioned also a little bit earlier, we're building here on a lot of experience and the successful development of cabozantinib. And with that, we feel that the program is importantly, de-risked with that experience. We are making progress in the dose escalation for single-agent XL092 in the combination with checkpoint inhibitors atezolizumab notably. And as we are expecting or have expected from our cabo experience, we're beginning to see preliminary promising antitumor activity in heavily pretreated Phase I patients.

And we also have already presented the pharmacokinetic data. And we're seeing a safety profile that is consistent with our expectation and knowledge of the pathway. So with that, I think we are very, very focused on driving the program forward and introducing further combinations, as I mentioned on the call a little bit earlier. And we certainly also expect to drive forward the development program toward start of pivotal studies in 2021, data providing. And so certainly, with that, we also will present data on XL092 in combination when the time comes. But we're laser-focused on advancing the development program as the primary priority.

Operator

Your next question comes from the line of Andy Hsieh with William Blair.

Andy Hsieh -- William Blair -- Analyst

Great. Congratulations on the full-out quarter. But two for P.J. I think through all those commentaries on the initial trajectory of the cabo launch. So I am interested in knowing -- taking a macro view. You mentioned that the TKI market grew 19%. I remember you mentioned about kind of the shrinking market during the test of the COVID-19 pandemic. Can you provide us with some commentary about what you're seeing relative to kind of the diagnosis rate, patient pool and where we are in the pandemic?

P.J. Haley -- Executive Vice President, Commercial

Yes, Andy, this is P.J. Thanks for the question. Certainly happy to provide a little more commentary there. As you mentioned, we did see in Q1 according to the IQVIA data that NRx is for the market basket, as we define it, CISV grew by 19%. CABOMETYX for NRx grew 31% quarter-over-quarter. So very pleased with that. And as I mentioned, we were the only product in that market basket to grow shares. So excited with regards to that, and as we mentioned, it was driven by the combination of launch.

So that's great. I do think with regards to kind of what we're seeing and hearing anecdotally from our customers, is things are -- obviously, with regards to pandemic, it is regional, it's varied and things are dynamic and they do change. But generally, we see things getting back to some semblance of normalcy. And I would expect that as we get deeper into the year, that will kind of continue. It's certainly helping us with access to our customers and education of them, and we're hearing from them that things are, as I mentioned, kind of slowly getting back more to normal. But I think there's still some opportunity for that to continue to improve broadly.

Andy Hsieh -- William Blair -- Analyst

Okay. That's helpful. And also for -- regarding the FDA AdCom last week, any potential implications for the second-line HCC market dynamics? I think the panelists recommended pulling Opdivo but retaining KEYTRUDA's label in that setting?

P.J. Haley -- Executive Vice President, Commercial

Yes. Thanks for the question again, Andy. It's P.J. Certainly something we're tracking very closely with regards to all of those. Obviously, we won't speculate on what FDA will do there. But what I would say with regards to Opdivo or even generally monotherapy in HCC, which is primarily in that second-line setting. As we've talked about for some time now with atezo/vem being approved for about a year now and building kind of a first-line combination market, becoming standard of care there. What we've seen is that shift of IO utilization from second-line monotherapy going to the first line. While that has completed that, shift is kind of already well under way and happening, which opens up more room for single-agent TKI utilization in the second line.

So I think if anything, depending on how that plays out or the kind of the coverage there, just might potentially accelerate that a little bit. But I think the market is shifting as is. And obviously, we'll see how 312 reads out soon, and there'll be more potential for that market to dynamically change. And I think importantly, there in HCC, we're seeing and expect to continue to see more patients coming into that, so to speak, first-line funnel with more and more therapeutic options that are going to be helpful for patients available.

Andy Hsieh -- William Blair -- Analyst

And maybe one kind of Street question for Mike or Peter. I was just wondering can Exelixis leverage its chemistry foundation and kind of the new -- newly obtained capabilities in biologics, I think, outside the box. So basically, beyond the traditional framework of kind of like an antibody-linked payload contract for ADC?

Michael M. Morrissey, Ph.D. -- President and Chief Executive Officer

Thanks, Andy. That's a great question for Peter. So I'm going to pass it over to him.

Peter Lamb, Ph.D. -- Executive Vice President, Scientific Strategy and Chief Scientific Officer

Yes. Thanks, Andy. It's a great question. Period. And I think your view of it is essentially correct. If you look at the history of ADCs, and we've had, what, 20 years of ADC discovery and development at this point, the vast majority of the payloads that people have used have fallen into broadly three or four classes of mechanism of action. And it's predominantly been microtubule destabilizing agents of one kind or another or DNA-damaging type agents Topoisomerase-type inhibitors. So I think there's a lot of interest in trying to develop novel payloads. We're starting to see it a little bit. I would say, a number of folks are working on immuno stimulatory payloads of various classes.

So as you point out, with our kind of 20-plus year history in medicinal chemistry here, kind of escaped our notice, but this might be an attractive area to explore further. I think there's a lot of opportunity there. I think it would dovetail very well with the collaborations that we established late last year with NBU and Catalent to access their site-specific conjugation technologies, and the ongoing efforts that we have to assemble kind of essentially a library of antibodies and binders that would be attracted -- against attractive targets for ADCs, either through our Invenra collaboration or opportunistically through the collaborations of all the licenses we did with WuXi late last year and this week with GammaMabs. So great questions. Stay tuned on that point. And look forward to updating everyone broadly on what we're doing in ADCs going forward.

Operator

Your next question comes from the line of Yaron Werber with Cowen.

Gabe Daoud -- Cowen -- Analyst

This is Gabe on for Yaron. Just a follow-up to one of the previously asked questions about cabo. You guys are obviously making great progress quarter-over-quarter in first-line renal cell. Could you share what fraction of all NRxs are going to cabo in Q1 compared to Q4? And kind of what -- a little color maybe on what feedback you're getting from physicians or payers as to why they may be sticking with other 1L options -- first-line options besides cabo Opdivo in certain cases as opposed to embracing 9ER pretty much across the board.

P.J. Haley -- Executive Vice President, Commercial

Yes. Thanks for the question, Gabe. This is P.J. So I guess, first, I'll start with the numbers and the data. What we had in Q4 was an NRx market share, the market basket of 32%. And in Q1, the NRX market share for CABOMETYX was 36%, and the volume growth for CABOMETYX Q1 over Q4 was 31%. And I guess the way I kind of think about that is we're really pleased with the -- that start there, particularly since our approval came in late January, and we're seeing actually, you mentioned payers. We're seeing really minimal pushback on the payer side of the data.

So sort of clear-cut. That's great. So we're seeing great adoption and policies broadly from a payer perspective. And I think the physician perceptions, as I mentioned, of the data, really good. And we're really pleased with that level of education. I think we have continued opportunity to continue to educate really in the community, particularly as things open up more with regards to optimism around the pandemic. And I think the more we get to get in front of physicians with our database and what we're seeing, we'll continue to make progress there. We're certainly optimistic.

Operator

Our next question comes from the line of Michael Schmidt with Guggenheim.

Michael Schmidt -- Guggenheim -- Analyst

Congrats on the great first quarter. I actually had a couple of pipeline questions as well. First, perhaps on XL092, a mechanistic question here. So it's pretty obvious that the shorter half-life of this molecule relative to CABOMETYX will probably make it easier to dose and manage the toxicity profile. Could you just help us understand how that mechanistically transferred into a potential improved efficacy benefit relative to experience with CABOMETYX? And then I had a second question.

Michael M. Morrissey, Ph.D. -- President and Chief Executive Officer

Yes, why don't we -- thanks, Michael. It's Mike. Why don't we let Peter take a crack at that and maybe Gisela can provide some color commentary, too. Go ahead, Peter.

Peter Lamb, Ph.D. -- Executive Vice President, Scientific Strategy and Chief Scientific Officer

Yes. So I think the goal of 092, as you correctly stated, was to maintain the overall target profile of cabozantinib, hitting all the same major targets in pretty much the same ratios so that we could build off the extensive experience that we have with cabozantinib clinically with a single agent and in combination, but to reduce the half-life. So made some appropriate chemical modifications aimed at doing just that. And happily, that has played out well in the clinic.

The aim, as you stated, is to provide a way to manage the dosing and site management of side effects as fast as possible. And a shorter half-life certainly helps you do that. So I would say, overall, any time you can optimize your dose and dosing for individual patients, you maximize the chance of providing them with clinical benefit.

Michael M. Morrissey, Ph.D. -- President and Chief Executive Officer

Gisela, any thoughts there?

Gisela M. Schwab, M.D. -- President, Product Development and Medical Affairs and Chief Medical Officer

Yes. I agree with everything Peter said. And perhaps just to add, of course, it's about continued dosing. And as patients benefit to maintain dosing for the duration as long as patients derive benefit. The other thing to offer perhaps, in addition, is one additional thought is, of course, combinability. And there, I think, facile dose adjustment with the shorter half-life comes in handy. That is perhaps another consideration.

Michael Schmidt -- Guggenheim -- Analyst

Great. And then just one on XL102. We've noticed a lot more interest now in all the sales cycle targets, for example, such as CDK2 or V1 and others, p53, etc. Just remind us where CDK7 sits in here and whether that's a target that is expected to be broadly active or whether this is -- whether inhibition of CDK7 would be preferentially pursued in a certain genetic contexts or biomarker-positive patient population?

Peter Lamb, Ph.D. -- Executive Vice President, Scientific Strategy and Chief Scientific Officer

Yes, this is Peter. I'd be happy to take that one. So again, you're absolutely right. There's been another uptick in interest in CDKs broadly, and I would say, CDK7, specifically. CDK7 sits actually upstream of the classical cell cycle CDKs, which is CDK1 and two, and is responsible for activating those kinases. It's also upstream of CDK4 and six, which were obviously the target for the cyclic class of approved drugs. So it does play a major role in orchestrating the sales cycle. There is also maybe some role for it as well in regulating the initiation of transcription through its ability to take either directly phosphorylate transcription factors or help mediate the assembly of the kind of transcription or preinitiation complex.

So it plays more than one role. But product seems pretty predominantly on the cells cycle side. So if you look at the profile of CDK7 inhibitors, including our own, certainly, in vitro and in vivo, it's broadly active, as you might expect for something working on the cells cycle. A lot of the indications that are being contemplated do tend to focus more on tumors that have genetic lesions that affect the activity of CDK such as RB deletion, for example or amplifications in various cyclin genes. Another obvious place for it is potentially as a treatment in tumors that become resistant to CDK4/6 inhibitors and CDK7 is upstream of those. So there's a lot of places to go therapeutically potentially with a CDK7 inhibitor, and I think that's driving -- helping drive a lot of the interest, including our own.

Operator

Your next question comes from the line of Jay Olson with Oppenheimer.

Jay Olson -- Oppenheimer -- Analyst

Congrats on all the progress. And if CONTACT-01 is successful, could you comment on the potential to move cabo plus atezo or maybe 092 plus atezo into first-line, non-small cell lung cancer? And would that depend on PD-1 expression levels or some other biomarker-driven approach?

Michael M. Morrissey, Ph.D. -- President and Chief Executive Officer

Yes. Thanks, Jay. Gisela, do you want to take that one?

Gisela M. Schwab, M.D. -- President, Product Development and Medical Affairs and Chief Medical Officer

Sure. Thank you. Yes. So just to explain CONTACT-01, of course, is in the previously treated patient population who have received prior checkpoint inhibitors and that Phase III study is ongoing. We've already presented data from the COSMIC-021 study and have seen encouraging activity for the combination of cabo and atezo in this setting in ICI-pretreated patients.

I think as we're thinking about earlier lines of therapy and perhaps also combinations that could then be relevant for XL092 as we go forward, certainly very interested in the atezo combination that is ongoing in this space with XL092 and further combinations and certainly, the work that Genentech Roche is conducting in non-small cell lung cancer, combining atezolizumab with the TIGIT antibodies of interest and they're here with some intriguing data in earlier line setting. Whether or not that will be then confined to patients selected by P1, PD-L1 expression, I think that remains to be seen.

And perhaps there's opportunity when combining with a TKI to broaden the patient population. So certainly a lot to evaluate, but it's a very interesting space and a lot of opportunity, I think, for XL092 and also, of course, for cabo and atezo.

Jay Olson -- Oppenheimer -- Analyst

That's very helpful. And if I could maybe sneak in another question on 092. Have you seen any preclinical data that shows potential synergy between 092 and any of your early stage ADCs or small molecules?

Michael M. Morrissey, Ph.D. -- President and Chief Executive Officer

Yes, it's a great question. That kind of work is actually in progress right now. So I can't comment on it yet, but stay tuned.

Operator

Your next question comes from the line of Kennen MacKay with RBC Capital Markets.

Kennen MacKay -- RBC Capital Markets -- Analyst

Congrats on the quarter. Sort of a qualitative question on the frontline market here. I'm just wondering where you're gaining more traction, whether it's academic or community clinics? And then some of the feedback we've had is from some physicians that -- what they appreciate most about the combination is its potential to induce super, super fast and deep CRs or very, very deep PRs. And as a result of that, they're maybe using it in patients with bulkier tumors. Wanted to hear if that was something that the team was hearing as well or whether it's just such a broad market, too early to say.

P.J. Haley -- Executive Vice President, Commercial

Yes. Kennen, this is P.J.. Thanks for the question. As I mentioned, I think the uptake is really -- it has been broad. And the feedback that we've received is that it really is the data resonating across sort of a variety of clinical subset, so to speak, or if you want to be specific, its defining it as the IMDC. So favorable, intermediate and poor, I'd say, at this early stage, we're seeing it broadly and I wouldn't really say differentially based on the early data, but stay tuned. Your comments specifically about, say, kind of a symptomatic patient needing a response.

That's something that generally, I think, has been a hallmark of cabo in monotherapy in a later setting. But certainly, as physicians begin to see the data in 9ER, I think that certainly plays -- it thought out to be used in those types of patients, which are certainly gratifying. That said, even on the other end of the spectrum, you see us doing really well in the favorable risk category. And we've just recently gotten NCCN category one recommendations across all those risk groups. I think that will continue to provide momentum for us, particularly in that favorable setting. But we're gratified we're seeing uptick across all patient types and hearing from physicians that it's benefiting their patients.

Operator

Your next question comes from the line of Paul Choi with Goldman Sachs.

Paul Choi -- Goldman Sachs -- Analyst

Let me also add my congratulations on the quarter. My first question is for Gisela. Just with regard to the CONTACT-01 and two programs. I know you indicated that both those studies are enrolling. But could you maybe indicate whether some early initial data from early enrolled patients might be possible by later this year? And then I had a follow-up on the commercial -- or financial side for Chris

Gisela M. Schwab, M.D. -- President, Product Development and Medical Affairs and Chief Medical Officer

Thanks. Yes. On CONTACT-01 and two and three, for that matter, all of these Phase III studies are involving patients globally, and we're pleased with the progress on the studies, for sure. The data is not expected to be available this year. These are phase -- relatively sizable large Phase III studies. And of course, the endpoints are time-to-event endpoints, depending on the study, PFS and OS or it's itself. So that will take a little bit longer, and it's to be expected not before 2022.

Paul Choi -- Goldman Sachs -- Analyst

Okay. And then one for Chris. I think in the last quarter, you highlighted a $7.5 million inventory benefit. I was wondering if you could quantify it for this quarter as well. And then just given the strong start to the year, you left guidance unchanged. So I was just curious what was the sort of thinking at least behind that raising the low end of the revenue guidance.

Christopher J. Senner -- Executive Vice President and Chief Financial Officer

Paul, thanks for the question. So on the inventory side, I mean, we didn't quantify it this time, but it's about 300 units. And in the $6 million range at our wholesaler acquisition costs, about $4.5 million, if you think about it net benefit perspective. So -- or net detriment to this quarter perspective. And then guidance. Yes, sorry. From a guidance perspective, we're very pleased with where we started the year. We continue -- as P.J. said, it was -- we had about two months into the quarter -- or two months in the quarter from a performance perspective. And we continue -- we're going to continue to monitor it. It's a very dynamic market. There's a lot of competition in the market, and we're going to continue to do it. And it's very early in the launch. So we'll continue to look at it and revisit it in the future quarters.

Operator

[Operator Instructions] And your last question comes from the line of Stephen Willey with Stifel.

Stephen Willey -- Stifel -- Analyst

Congratulations on the quarter. Just a couple of quick prostate questions. So I guess, at the time of the Cohort six disclosure and/or presentation, will we see some of the additional cohort data that's been embedded within this COSMIC-021 trial design in terms of -- I think there's a single agent atezo or single-agent cabo cohort. Just wondering if you plan to present that in conjunction with Cohort six disclosure? And then I just have a quick follow-up.

Michael M. Morrissey, Ph.D. -- President and Chief Executive Officer

Yes, it's Mike. It's probably a little bit too early to opine upon or speculate on how we'll roll all that out. We understand the importance of the data relative to both keeping investors up-to-date on what's happening, but also relative to a filing. So stay tuned. Let's get the BIRC done, and then we'll roll out data at the appropriate time.

Stephen Willey -- Stifel -- Analyst

Perfect. And I guess, in any of the regulatory dialogue you've had with FDA, would do you think that a label here is going to be limited to patients with measurable disease at baseline? Or do you think that there is an opportunity that you could get a bit of a broader language that would allow you to treat some of these patients that have bone only disease as well.

Michael M. Morrissey, Ph.D. -- President and Chief Executive Officer

Yes. Look, I wouldn't want to speculate on those -- on the outcome of those discussions that we have, and I wouldn't want to talk about the discussions either. I think it's probably safe to say that labels usually align with populations that were studied. So I would think about it from that point of view. I think that's not really the safest way to go. But we'll -- again, when we get that far and we're thinking about releasing that information, we'll be happy to share that with you at the appropriate time.

Operator

At this time, there are no further questions. And so I will turn the call over to today's host, Susan Hubbard. Ms. Hubbard?

Susan T. Hubbard -- Executive Vice President, Public Affairs and Investor Relations

Thank you, Daphne. And thanks, everybody, for joining us today. Certainly happy to take your follow-up calls with any additional questions you may have after we conclude. Thanks, again.

Operator

[Operator Closing Remarks]

Duration: 66 minutes

Call participants:

Susan T. Hubbard -- Executive Vice President, Public Affairs and Investor Relations

Michael M. Morrissey, Ph.D. -- President and Chief Executive Officer

Christopher J. Senner -- Executive Vice President and Chief Financial Officer

P.J. Haley -- Executive Vice President, Commercial

Gisela M. Schwab, M.D. -- President, Product Development and Medical Affairs and Chief Medical Officer

Peter Lamb, Ph.D. -- Executive Vice President, Scientific Strategy and Chief Scientific Officer

Asthika Goodewarne -- Truist Securities -- Analyst

Jason Gerberry -- Bank of America -- Analyst

Amy Lee -- Wolfe Research -- Analyst

Waleed Abdel-Naby -- Barclays -- Analyst

Andy Hsieh -- William Blair -- Analyst

Gabe Daoud -- Cowen -- Analyst

Michael Schmidt -- Guggenheim -- Analyst

Jay Olson -- Oppenheimer -- Analyst

Kennen MacKay -- RBC Capital Markets -- Analyst

Paul Choi -- Goldman Sachs -- Analyst

Stephen Willey -- Stifel -- Analyst

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