Edited Transcript of EXEL earnings conference call or presentation 5-May-20 9:00pm GMT

And now with that, I will turn it over to Mike.

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Michael M. Morrissey, Exelixis, Inc. – CEO, President & Director [3]

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All right. Thank you, Susan, and thanks to everyone for joining us on the call today.

Exelixis had a strong first quarter across all components of our business. Our entire team working remotely as a cohesive unit continues to navigate the challenges of the COVID-19 pandemic with a singular focus of ensuring that we do everything in our power to maximize access to cabozantinib for cancer patients through either commercial channels or clinical trials. We recognize that cancer patients need to take their treatments as directed, and we’ve gone to great lengths to ensure patient access to our medicines in these challenging times.

We’ll keep our prepared remarks short and address your questions as the main part of today’s update. Please see our press release that was issued an hour ago for our first quarter 2020 financial results and an extensive list of corporate highlights.

Before we review the performance of our business in the quarter, I want to provide a brief update on how Exelixis has responded to COVID-19 at an organizational level. Our top priority is the health and safety of the Exelixis workforce. So we implemented our work-from-home policy ahead of the California shelter-in-place order and quickly pivoted our sales force to move to virtual touch points with prescribers.

At the same time, the 600-plus members of our Exelixis team have engaged in the fight against COVID-19 on the community level by donating to charitable organizations supporting cancer patients during the pandemic, which Exelixis has matched at the corporate level and through the donation of personal protective equipment to a local care facility. We like to think that tough times brings out the best in people, and I’m proud to say that’s certainly the case at Exelixis.

The COVID-19 pandemic continues to evolve quickly and has had a relatively modest impact on our business to date. We remain optimistic that the 2020-2021 time frame can be a period of focused execution and achievement for Exelixis. While the pandemic is imposing challenges on our day-to-day operations and gives rise to a level of uncertainty, we remain on track to have 12 label-enabling trials for cabozantinib enrolling by year-end and achieve top 6 line data readouts over the course of the year, which could lead to 4 new potential indications for cabo in 2021.

We also expect to advance XL092 into immune checkpoint inhibitor, or ICI, combination cohorts and file up to 3 new INDs for compounds from internal or collaborative efforts. Obviously, everything is fluid at this stage, and we’ll continue to update you as we progress throughout the year.

The recent success of CheckMate 9ER with the cabo/nivo combination in first-line RCC highlights the important role cabozantinib can play as a TKI backbone in driving both compelling efficacy and tolerability in ICI combination strategies and provides potential encouraging read-through for ongoing and planned pivotal trials for other ICI combinations and new indications.

Finally, as you know, we have an ongoing ANDA litigation against MSN. Earlier today, we received notice that MSN has filed additional Paragraph IV certifications, challenging the cabozantinib composition of matter patent and a method of use patent, 2 Orange Book listed patents not asserted in their original Paragraph IV letter. We are not surprised by this development as such challenges are standard in the ordinary course of the pharmaceutical business. We are well prepared to respond and vigorously defend what I believe to be a very strong intellectual property estate that protects cabozantinib, an innovative drug of growing medical importance.

So with that, I’ll turn the call over to Gisela who will provide an update on CheckMate 9ER and other 2020 development activities. Gisela?

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Gisela M. Schwab, Exelixis, Inc. – President of Product Development & Medical Affairs and Chief Medical Officer [4]

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Thank you, Mike. I’m very pleased to provide a brief update on our development and regulatory progress in the quarter.

I’ll start with a very exciting recent announcement for the pivotal Phase III study, CheckMate 9ER, per our sales and BMS. This important Phase III trial compares cabozantinib plus nivolumab with sunitinib in previously untreated patients with RCC, including all IMDC risk groups. The study completed enrollment earlier in 2019, and as projected, has now achieved top line results as announced on April 20, 2020. We are extremely pleased with the results that showed that CheckMate 9ER met all 3 efficacy endpoints. The primary endpoint was progression-free survival assessed by independent radiology committee. Cabozantinib, in combination with nivolumab, significantly reduced the risk of disease progression or death compared with sunitinib with a hazard ratio of 0.51 and a p-value of less than 0.0001.

The secondary endpoints were overall survival and objective response rate. The combination of cabozantinib with nivolumab also significantly improved overall survival compared with sunitinib with a hazard ratio of 0.60 and a p-value equal to 0.001 and the objective response rate with deep and durable responses observed.

The median follow-up time was 18.1 months. The preliminary analysis of the CheckMate 9ER safety data showed a favorable safety profile with the combination of a 40-milligram dose of cabozantinib combined with nivolumab with a low frequency of treatment discontinuations due to adverse events.

We would like to thank the patients who participated in this trial as well as the investigators and site personnel for their perseverance during the conduct of the study and for ultimately delivering these important results for patients in the midst of the COVID-19 pandemic.

We’d also like to congratulate our collaborators at Bristol-Myers Squibb who sponsored the trial and look forward to our continued collaboration with BMS as we work toward regulatory filings in the near future. We also look forward to the detailed results of CheckMate 9ER that will be submitted for presentation at an upcoming medical conference.

These striking results provide further clinical support for the concept that cabozantinib may enhance the activity of immune checkpoint inhibitors and add to the growing body of preclinical and clinical data for the scientific rationale for combining cabozantinib with immune checkpoint inhibitors.

Moreover, the tolerable safety profile as seen in the preliminary analysis of safety data from CheckMate 9ER, further reinforces the 40-milligram cabozantinib starting dose in combination with nivolumab, and it expands on similar observations and the CheckMate 040 Phase Ib trial in hepatocellular cancer presented at ASCO GI and also our Phase Ib trial of cabozantinib and atezolizumab in COSMIC-021 cohort 6 in prostate cancer presented at ASCO GU this year.

The scientific rationale for combining cabozantinib and checkpoint inhibitors is directly relevant for our broader ongoing and near-term planned development programs for cabozantinib across different tumor types. This program spans our 12 ongoing or near-term planned pivotal studies, including our ongoing Phase III trial of cabozantinib in combination with nivolumab and ipilimumab versus nivolumab and ipilimumab in first-line RCC, the COSMIC-313 trial, as well as the Phase III trial, COSMIC-312, in first-line HCC comparing cabozantinib and atezolizumab versus sorafenib and our large multi-cohort Phase Ib study evaluating the combination of cabozantinib and atezolizumab in 24 cohorts across many different tumor types and settings, as well as our near-term planned Phase III studies in non-small cell lung cancer, the RPC and renal cell cancer under our Roche 50-50 clinical collaboration agreement. This broad late-stage cabozantinib development program is making very good progress, even in the face of the challenges that the COVID-19 pandemic presents for patients and sites given travel restrictions and quarantine.

And to close, just a few words regarding the upcoming ASCO conference. We look forward to presenting results from 3 cohorts of our COSMIC-021 study, evaluating cabozantinib and atezolizumab and checkpoint inhibitor pretreated non-small cell lung cancer and second-line bladder cancer, as well as biomarker results from our cohort 6 in prostate cancer and additional presentations, including a randomized Phase II study comparing cabozantinib and nivolumab with single-agent nivolumab in endometrial cancer from the NCI-CTEP program.

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

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Christopher J. Senner, Exelixis, Inc. – Executive VP & CFO [5]

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Thanks, Gisela. For the first quarter 2020, the company reported total revenues of $226.9 million. Total revenues for the quarter included cabozantinib franchise net product revenues of $193.9 million. Compared to the fourth quarter 2019, inventory of CABOMETYX held at our customer increased by approximately 500 units and inventory weeks on hand increased to approximately 2.9 weeks from 2.6 weeks and remains within the typical range of inventory weeks on hand. Total revenues also included $33 million in collaboration revenues from the company’s commercial collaboration partners, Ipsen, Takeda and Genentech.

Our total operating expenses for the first quarter 2020 were $174.1 million compared with $163 million in the fourth quarter of 2019. R&D expense was the primary driver of the increase in total operating expenses, which increased by approximately $7 million and was primarily related to increases in clinical trial expenses, as we continue to invest in maximizing the full clinical and commercial potential of cabozantinib.

Provision for income taxes for the first quarter 2020 was $11.4 million, and our effective tax rate for the quarter was 19% compared to $16.3 million and 19.1% for the fourth quarter of 2019.

Company reported GAAP net income of $48.6 million or $0.15 per share on a fully diluted basis for the first quarter of 2020. Company also reported non-GAAP net income of $59.4 million or $0.19 per share on a fully diluted basis. Non-GAAP net income, excluding the impact of approximately $10.8 million of stock-based compensation expense, net of the related income tax effect.

Cash and investments increased by approximately $52 million during the quarter ended March 31, 2020, to over $1.4 billion.

Now turning to our financial guidance. While we recognize the impact of COVID-19 pandemic is a very fluid situation, we continue to believe in the strength of our business, and therefore, we are maintaining the financial guidance we provided earlier this year.

Total revenues are expected to be in the range of $850 million and $900 million. Net product revenues are expected to be in the range of $725 million and $775 million. Cost of goods sold is expected to be between 4% and 5% of net product revenues. Research and development expenses are expected to be in the range of $460 million and $500 million and includes noncash expenses related to stock-based compensation of approximately $25 million. Selling, general and administrative expenses are expected to be in the range of $230 million and $250 million and include noncash expenses related to stock-based compensation of approximately $30 million.

Our guidance for the effective tax rate in 2020 is expected to be between 20% and 22%. And finally, we are projecting cash and investments to be in the range of $1.5 billion and $1.6 billion. This cash and investments guidance does not include the impact of any potential new business development activities.

With that, I’ll turn the call over to P.J.

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Patrick J. Haley, Exelixis, Inc. – EVP of Commercial [6]

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Thank you, Chris. I’m pleased to review the commercial performance of CABOMETYX for the first quarter 2020.

CABOMETYX continues to be the #1 prescribed TKI in RCC, which is notable in the context of an increasingly competitive market, which now includes 3 first-line immune checkpoint inhibitor, or ICI, combinations. With regards to the business, we did not see a significant impact of COVID-19 in the first quarter as CABOMETYX weekly demand was stable in Q1 2020 relative to Q4 2019. Our team has been and continues to be focused on compliantly supporting the health care providers who treat CABOMETYX patients since the pandemic has taken hold in the U.S.

We’re proactively communicating the availability of drugs supplied to our customers as well as supporting them by continuing to educate on the Exelixis Access Services or EASE program. We are doing this through virtual speaker programs, lunches, phone calls and digital tactics. Our customers appreciate this focus on ensuring their patients have appropriate access to CABOMETYX therapy in these challenging times.

In Q1, the prescriber base of CABOMETYX continued to grow, and CABOMETYX continues to be used broadly in RCC across academic and community settings, clinical risk groups and lines of therapy. As we have previously mentioned, the first-line RCC market stabilized in the second half of 2019, and this continued into Q1 where CABOMETYX first-line new patient share remains steady and ICI combos continue to capture the majority of the first-line new patient market share with approximately 75% of the market.

We are excited by the recent outcome of the CheckMate 9ER study as these results, pending regulatory approval, will provide us with the opportunity to grow CABOMETYX market share and increase duration of therapy in the first line. As we have now been in this market for over 4 years, our team has deep knowledge and experience in RCC, and we will look forward to the opportunity to educate physicians on this data at the appropriate time so that more patients have the opportunity to benefit from CABOMETYX therapy in the first-line setting.

We are particularly pleased with the progress that CABOMETYX has made in the second-line setting in Q1 where new patient market share increased to 45%. This was driven by more ICI combination pretreated patients progressing into the second-line setting where CABOMETYX continues to be the treatment of choice for the majority of these patients, primarily due to the fact that it is the only TKI with a strong OS benefit per the label in the second line population. We are pleased to see this trend play out in the marketplace and anticipate that the strength in the second-line market will continue.

Turning briefly to HCC. The U.S. CABOMETYX business remains stable. We anticipate the combination of atezolizumab and bevacizumab will receive approval in first-line HCC soon. Subsequently, the HCC landscape will likely evolve in a similar fashion to what we saw in the RCC market with ICI combination therapy moving to the front line, which could be an important new standard of care for treatment naive liver cancer patients and serve to expand the first-line market. We anticipate this will, in turn, increase TKI monotherapy utilization in the second-line setting, as second-line ICI monotherapy use decreases over time.

Additionally, we look forward to further ICI combination data with cabo in HCC to add to the CheckMate 040 data presented earlier this year. COSMIC-312 will provide the next Phase III readout of cabozantinib in combination with an immune checkpoint inhibitor and represents another potential growth opportunity for the franchise.

We strongly believe that there are many more eligible patients that could benefit from CABOMETYX. CABOMETYX remains the #1 prescribed TKI in RCC, and we look forward to building on this momentum in RCC, HCC and other potential future indications such as prostate and lung as our development program evaluating cabozantinib in combination with immune checkpoint inhibitors expands and progresses. The exciting data from 9ER is the first of these Phase III combination trials to read out, and we look forward to the opportunity to bring this combination to market as we continue to build the cabo franchise.

Our team remains highly focused and motivated to compete every day to bring the benefit of CABOMETYX 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 back over to Mike.

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Michael M. Morrissey, Exelixis, Inc. – CEO, President & Director [7]

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All right. P.J., thank you.

As I said in the intro, we’re off to a strong start in 2020. While we recognize the risk to our business, should the pandemic grow in severity or continue unabated, as of now we expect a data-rich year as we advance cabo towards new potential indications and additional compounds into the clinic.

We’re excited to present new data throughout the year and specifically at the upcoming virtual ASCO meeting. Most importantly, we hope to build on the momentum from the Checkmate 9ER top line results as we continue to chart our path to additional indications for cabo and build out a diverse portfolio of next-generation Exelixis cancer medicines.

I’ll close by thanking everyone at Exelixis for their truly Herculean efforts since early March. Our team has been working from home for almost 2 months now, continuing their efforts on behalf of cancer patients while also juggling the personal challenges that everyone is facing in these troubling and uncertain times. I have never been more proud or inspired by the team’s resilience, focus and commitment. The entire team is dedicated to making every day count even now under such trying conditions, 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. Thank you for your continued support and interest in Exelixis, and we’re happy to now open the call for questions.

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Questions and Answers

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Operator [1]

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(Operator Instructions) And your first question comes from the line of Asthika Goonewardene with SunTrust.

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Asthika Goonewardene, SunTrust Robinson Humphrey, Inc., Research Division – Research Analyst [2]

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This is Asthika Goonewardene from SunTrust. I want to say congrats on continuing to execute well. So with ASCO up ahead — I got a question for Gisela here. I have to. I’m not going to ask you about the lung cancer. But you’ve had some more time to analyze and do some of the biomarker results for the past rate precision prostate cancer from cohort 6. You had some time to kick the tires and, Gisela, I wanted to know — I’m not asking what the data is, but I’d like to get your view on what you think is the most interesting translational analysis that we’ll see in this data set. And then I got a couple of quick follow-ups after that.

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Gisela M. Schwab, Exelixis, Inc. – President of Product Development & Medical Affairs and Chief Medical Officer [3]

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Yes. Sure. Thank you for the question. So for the COSMIC-021 study, we have a pretty broad biomarker program that looks at various components of the immune cells, tumor cells, expression patterns and genetic alterations. So a broad program and without preempting here what the data says, we’re certainly looking forward to provide the information on the CRPC cohort, which you’ve seen already the clinical data at ASCO this year.

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Asthika Goonewardene, SunTrust Robinson Humphrey, Inc., Research Division – Research Analyst [4]

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Okay. And then — so overall, you’ve delivered on RCC, CRPC, non-small cell come around the corner and, hopefully, HCC led this year. But what’s the next tumor type maybe that’s coming out of 021 that’s going to be really exciting beyond this?

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Gisela M. Schwab, Exelixis, Inc. – President of Product Development & Medical Affairs and Chief Medical Officer [5]

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We have a number of irons in the fire, so to speak, and ongoing studies. And you mentioned yourself, we had the 312 study in first-line HCC that is ongoing and comparing cabozantinib plus atezolizumab versus sorafenib. You have the 313 study in RCC on the backbone of nivo/ipi, adding in cabozantinib. And certainly, a lot of indications going through evaluation in the COSMIC-021 study. We also — one indication you haven’t mentioned, I think, is our single-agent evaluation of cabozantinib in a differentiated thyroid cancer was looking in the second, third line setting, cabozantinib versus placebo in the COSMIC-311 study. For that trial, we’ve involved 100 patients in February, and we look forward with a sufficient follow-up of a minimum of 6 months to evaluate the objective response rate in that trial. So that’s ongoing and certainly lots to come as the year rolls on.

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Asthika Goonewardene, SunTrust Robinson Humphrey, Inc., Research Division – Research Analyst [6]

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Okay. And last one for Mike or Gisela. XL029 (sic) [XL092], can we have any sort of clarity on — I know it’s in the next — from this year that you’re planning on maybe have a first look at that. Any chance we can get a little bit more clarity on when we’ll see that?

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Michael M. Morrissey, Exelixis, Inc. – CEO, President & Director [7]

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Yes. Why don’t we — thanks for the question. Why don’t we have Peter address that? Peter Lamb, do you want to go ahead?

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Peter Lamb, Exelixis, Inc. – Executive VP of Scientific Strategy & Chief Scientific Officer [8]

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Yes. Sure. So for XL029 (sic) [XL092] and actually for a number of our more advanced preclinical programs, we’re definitely intending to present data on those in the second half of 2020. As we’ve kind of guided, we have the opportunity to file up to 3 INDs this year based on what’s going on preclinically right now. As of now, that opportunity is still there. So we look forward to getting some information out on a number of those programs and 029 — 092 in the second half, as I said.

I haven’t quite finalized yet exactly where or what meetings or exactly what the content will be. So stay tuned, and we’ll update as those details get logged down.

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Operator [9]

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

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Yaron Benjamin Werber, Cowen and Company, LLC, Research Division – MD & Senior Biotechnology Analyst [10]

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Nice quarter. I have a couple of questions. Maybe actually, let’s start — I think that 092 is actually critical to the way we kind of look at the business over the long term. And so maybe just a couple of questions. One, have you started the combination cohorts yet that were going to follow the monotherapy data? And then as you think about what you need to establish to move to Phase III, is it possible to start a pivotal next year? And then I have a question about cabo.

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Michael M. Morrissey, Exelixis, Inc. – CEO, President & Director [11]

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Gisela, go ahead, why don’t you answer that.

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Gisela M. Schwab, Exelixis, Inc. – President of Product Development & Medical Affairs and Chief Medical Officer [12]

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Sure. Sure. Thank you, Mike. So regarding your question where we are at on the 092 evaluation, we are in the dose escalation phase still on single agent but are preparing for the evaluation with checkpoint inhibitor combination and that we expect to occur in the next few months. And there are opportunities to expand cohort, a little bit like we’ve done in the COSMIC-021 study, enrolling a larger numbers of patients in certain indications. And if we like what we see there, we could potentially move forward relatively quickly from such observations, but it all will be data-dependent.

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Yaron Benjamin Werber, Cowen and Company, LLC, Research Division – MD & Senior Biotechnology Analyst [13]

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Okay. And maybe, Gisela, for ASCO, in COSMIC-021, the data in lung cancer and second line, can you give us a sense how many patients in combination with TECENTRIQ should we see? I recall it was expanded up to 80 patients. And then how do you look at what’s the right bar to move to a pivotal on both OR and, let’s say, durability of response?

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Gisela M. Schwab, Exelixis, Inc. – President of Product Development & Medical Affairs and Chief Medical Officer [14]

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Yes. Like we said in prior calls, we want to see sufficient follow-up in the cohort. And so that’s what we’ve been aiming for, for all our presentations and continue to do so. We’ll have the first look at that at ASCO for the lung cancer cohort and checkpoint inhibitor pretreated patients and certainly look forward to that first evaluation. And as you said, we’ve already begun to expand that cohort further. So I won’t get into specific patient numbers. We’ll see that shortly at ASCO.

And regarding your question on the bar, there’s certainly data out there on single agent approaches in this setting or combination approaches. And while we don’t want to speculate on numbers at this point, I think we certainly look forward to presenting the data at ASCO and showing you the results at that point in time.

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Yaron Benjamin Werber, Cowen and Company, LLC, Research Division – MD & Senior Biotechnology Analyst [15]

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Okay. And — but you’re thinking that if we look at the combination of docetaxel and [rumi], that kind of response rate in the 20s is the right bogey? You’re not thinking that docetaxel single-agent response rate of, let’s say, 16 or 6 to 16 are the bogey?

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Gisela M. Schwab, Exelixis, Inc. – President of Product Development & Medical Affairs and Chief Medical Officer [16]

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Yes. As I said, there are multiple data points out there and certainly in the literature, and you mentioned a couple. And so I’ll leave it right there.

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Yaron Benjamin Werber, Cowen and Company, LLC, Research Division – MD & Senior Biotechnology Analyst [17]

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Okay. Chris, maybe just a quick question. Just to make sure we heard you, and it’s my last question. Did inventories increase to 2.9 weeks from 2.6 weeks, and it remained within the normal range? I missed exactly the comments on the growth you mentioned in inventories.

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Christopher J. Senner, Exelixis, Inc. – Executive VP & CFO [18]

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Yes, Yaron, it’s Chris. So it — so the inventory did increase by about 500 units, which increased our weeks on hand from Q4, which is 2.6 weeks to 2.9 weeks as we ended Q1.

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Operator [19]

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

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Tsan-Yu Hsieh, William Blair & Company L.L.C., Research Division – Senior Research Analyst [20]

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I want to congratulate on the team for the positive and competitive 9ER result. So related to that, I think both the physician and investment communities are trying to do [cross from] comparisons and totally understand the patient and overall survival. But curious about your thoughts on progression-free survival in the context of a head-to-head comparison. Perhaps that’s a clear and maybe less confounded efficacy metric. Curious about your thoughts there.

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Michael M. Morrissey, Exelixis, Inc. – CEO, President & Director [21]

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Yes. Thanks, Andy. Gisela, why don’t you start there and then maybe P.J. can provide some color commentary, too.

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Gisela M. Schwab, Exelixis, Inc. – President of Product Development & Medical Affairs and Chief Medical Officer [22]

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Absolutely. So first of all, we’re really pleased, of course, that the study met all 3 efficacy endpoints and showed such strong and consistent results. Regarding PFS, it’s the primary endpoint evaluated by independent radiology review that is unconfounded, of course, by subsequent therapy because of the nature of how it is measured. And I think it certainly showed a very strong result, but so did the other endpoints.

With that, I’ll hand it on to P.J.

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Patrick J. Haley, Exelixis, Inc. – EVP of Commercial [23]

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Yes. Andy, based on the market research we’ve done in 9ER, first of all, we’re extremely excited by the results. The top line results we have out there, look forward to presenting it. It’s — really good, the totality of the data we’ve seen historically is — in terms of the efficacy is all important, depending on the patient, et cetera. So we’re pleased to have all these endpoints be positive with the strength they have.

And importantly, too, I think, in this, as we’ve mentioned, the tolerability profile is important as well. We hear that from physicians and are pleased with that as well from 9ER. And that’s certainly important to be able to get the patients on therapy and then appropriately manage them and keep them on therapy for a long time, which is why we’re excited about the results. This should be very important for the patients themselves and then really for the cabo business as we look to increase market share in the first-line setting and, ultimately, the duration there as well.

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Tsan-Yu Hsieh, William Blair & Company L.L.C., Research Division – Senior Research Analyst [24]

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Okay. Great. So at AACR, we saw the detailed results from the [Vascular 250] trial. So thanks, Gisela, for providing considered preclinical rationale of the potential synergy between cabo and checkpoint inhibitors. I’m just wondering about any additional thought to put the cohort 6 in context given what has transpired at AACR?

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Gisela M. Schwab, Exelixis, Inc. – President of Product Development & Medical Affairs and Chief Medical Officer [25]

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Yes. I think what was certainly interesting is, for us and our cohort 6 data, is that we saw a strong response rate for RECIST for the design of the trial, so the 32% objective response rate in a situation where neither cabozantinib nor atezolizumab resulted high response rates by themself. In fact, there are hardly any responses observed and published in this setting. So that, I think, signals to us a cooperative activity. And certainly, we have to base this on the biological front that cabozantinib resulted in a more immune permissive environment enabling the checkpoint inhibitor activities.

So I think that — I think the data that we can speak to [ambassador] with a negative study and didn’t show any improvement over enzalutamide alone in the combination and that in a large study. And so that’s a definitive answer at least for this particular setting and that combination. But I think we need to look at each combination and the biological rationale thereof independently.

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Tsan-Yu Hsieh, William Blair & Company L.L.C., Research Division – Senior Research Analyst [26]

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Okay. And 2 quick ones. Just an interesting observation. If you look at the KEYNOTE-426 study, it’s the Merck sponsored trial, JAVELIN Renal 101, that’s a Pfizer sponsored trial. So the data for both trials were not included in the [Lydas] label. So I’m just wondering if you can educate us on kind of the labeling process on the regulatory side given the fact that Bristol is kind of driving the process.

And also, in terms of the bench trial, thanks for the additional information in the 10-K, April 2022 start date, just want to make sure that if this goes all the way to the appeal process, during that time, is the patent still enforceable?

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Michael M. Morrissey, Exelixis, Inc. – CEO, President & Director [27]

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Okay. Gisela, why don’t you go ahead and take the regulatory question first, and then I’ll come back to the last question.

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Gisela M. Schwab, Exelixis, Inc. – President of Product Development & Medical Affairs and Chief Medical Officer [28]

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Sure. So regarding the inclusion of data in the label for a specific compound, that is, of course, the decision of each company to amend the label. And as we’ve stated in the past, we’re working collaboratively with BMS to work expeditiously towards a regulatory filing. And we would anticipate that, of course, to be led by BMS who was the sponsor of the study of CheckMate 9ER, but we would also anticipate a more or less parallel filing to the cabozantinib label. So it’s ultimately a decision of the sponsor, really.

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Michael M. Morrissey, Exelixis, Inc. – CEO, President & Director [29]

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Andy, it’s Mike. And your last question, obviously, all the patents in the Orange Book are enforceable.

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Operator [30]

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

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Peter Richard Lawson, Barclays Bank PLC, Research Division – Research Analyst [31]

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On the 9ER data, congratulations then. And then on top of that, are you seeing any off-label use by physicians after hearing about the top line data, if you’ve seen that uptick? And I’ve got a follow-up after that.

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Patrick J. Haley, Exelixis, Inc. – EVP of Commercial [32]

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Yes. Peter, it’s P.J. Well, first and foremost, we obviously don’t promote any off-label data. And I will say, it’s very early in the data not having been presented. I think, generally, in general terms, I wouldn’t expect any of that.

At this point, I mean, I think what we’re pleased by — what I mentioned in my prepared remarks in terms of Q1 is really the strength in the business in terms of being stable in first-line RCC new patient market share from a monotherapy perspective and then certainly very pleased with growth in our second-line new patient share now reaching 45%. So very pleased with that momentum in the current business as well as excitement in preparing for an IDR.

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Peter Richard Lawson, Barclays Bank PLC, Research Division – Research Analyst [33]

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And then, I guess, kind of a follow up around COVID. Are you seeing any increased cabo use amid social distancing and any way of breaking that out? And do you think if you are seeing that benefit, does that stay?

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Patrick J. Haley, Exelixis, Inc. – EVP of Commercial [34]

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Yes. Peter, thanks for the question. Yes, we haven’t seen any incremental use from that perspective. It certainly occurred at the shutdown at the end of Q1. Just really pleased our team is doing everything they can to support our customers who treat the patients who are on CABOMETYX. So they’ve been doing that appropriately, they have a lot of digital tactics in place generally. We’re doing more of those. We’ve been able to convert a lot of our in-person meetings, communications, speaker programs to virtual, either telephone or online meetings, which is great, doing that compliantly. Like I said, I think the strength we’re seeing in the business is really related to the increase in second-line market share.

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Operator [35]

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

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Michael Werner Schmidt, Guggenheim Securities, LLC, Research Division – Senior Analyst & Senior MD [36]

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And congrats on the quarter and CheckMate data as well from me. Maybe just a follow-up for P.J. What market share does in light of KEYTRUDA combination now have in the frontline RCC setting? And how do you think about potentially overcoming any kind of potential inertia by physicians to switch over either from that or from ipi/nivo over to cabo, Opdivo pending approval of that label?

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Patrick J. Haley, Exelixis, Inc. – EVP of Commercial [37]

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Yes. Michael, thanks for the question. So what I mentioned in the prepared remarks and what we’ve said previously is that the ICI combinations have really stabilized, and that’s going back to the end of last year in terms of their market share — new patient market share in the first line, somewhere around the 75% range altogether. And I think, approximately, you could think of pembro/axi/nivo would be approximately each having half of that.

So I think when we look forward at the 9ER launch, we’re certainly really excited, and the data will be very important. So we’re pleased that we have good data and look forward to presenting that.

The other thing I think about is our team has a lot of experience now in this market in RCC. We’ve now been approved in RCC for just over 4 years and have a stable team in place in that time with a lot of depth of knowledge and relationships, frankly, in the marketplace. So I think that’s a great thing.

And then as you look at the 2 drugs we’re talking about here, and we said previously, CABOMETYX, Opdivo, really the first and only monotherapies to show an overall survival benefit in RCC, which certainly gave us optimism in terms of the trial results. So we’re really excited to work with that and build on that as we move forward for the launch.

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Michael Werner Schmidt, Guggenheim Securities, LLC, Research Division – Senior Analyst & Senior MD [38]

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Great. And then just on COSMIC-021, I know that you and Roche have committed to a Phase III trial for some time now in non-small cell lung cancer. And I was just wondering if there is still an opportunity to maybe consider an accelerated approval pathway in this indication, like you have done in prostate cancer, or if this is certainly to go into a fully-fledged randomized Phase III trial at this point.

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Gisela M. Schwab, Exelixis, Inc. – President of Product Development & Medical Affairs and Chief Medical Officer [39]

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This is Gisela. I think, obviously, we want to see the data at ASCO. And as you know, we have expanded as a cohort to a total of 80 patients to be enrolled in the COSMIC-021 study, and any such considerations would be entirely data-driven. That said, we are moving forward jointly with our collaborators at Roche on the program across these 3 Phase III studies in lung cancer, prostate cancer and also RCC and look forward to starting those studies in the next few months.

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Michael Werner Schmidt, Guggenheim Securities, LLC, Research Division – Senior Analyst & Senior MD [40]

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Okay. And then maybe just one more, Gisela, on — with regards to the cohort 6 prostate cancer arm of the study. How should we think about potentially updating that cohort down the road at a medical conference before potentially filing should the data warrant that in prostate?

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Gisela M. Schwab, Exelixis, Inc. – President of Product Development & Medical Affairs and Chief Medical Officer [41]

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Sure. I think right now, it’s a little bit too early to say because, of course, we will want to see sufficient follow-up and so forth the expanded cohorts. But we would anticipate certainly presenting the data once mature. And whether or not that coincides or comes before any regulatory steps if warranted for the data, that really remains to be seen. It’s a little bit hard to tell right now.

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Operator [42]

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

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Jason Matthew Gerberry, BofA Merrill Lynch, Research Division – MD in US Equity Research [43]

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A couple for me. Just first, in renal cancer, one of the things that we’re hearing from physicians is that use of Opdivo Yervoy is coming under pressure because patients who might get this here in a high-risk age demographic, the Yervoy-related immune toxicities are a concern. So I’m wondering about how you see that as potential opportunity as the CheckMate 9ER opportunities eventually rolled out into the market because the obvious beneficiary is the TKI mono or an IO TKI combination. So first, I guess I’ll just leave that there. Just to get you guys’ thoughts on that question.

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Patrick J. Haley, Exelixis, Inc. – EVP of Commercial [44]

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Yes. Jason, it’s P.J. I think with regards to the data we’ve seen in the market thus far in terms of market data, sort of commercial data, we haven’t seen, as I kind of mentioned previously, big impact to COVID one way or the other. We’re pleased that the cabo business is strong and that our TKI monotherapy front line market share is stable. And in particular it’s growing in the second line as more patients just really in the kinetics over time are progressing off of immune checkpoint inhibitor therapies. And we’re capturing the vast majority of those in the second line, and we anticipate that strength to continue.

But as far as speculating with regards to COVID, so many months out with regards to our launch. I wouldn’t really want to do that. I think what’s really going to be important is the data, and we’re really pleased to be able to have the opportunity to bring that to customers.

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Jason Matthew Gerberry, BofA Merrill Lynch, Research Division – MD in US Equity Research [45]

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Got it. So it sounds like you don’t see much of an impact to the Opdivo-Yervoy combo in renal. My other question was just on lung. I realize that you guys aren’t going to say much about patient enrollment strategy. But from what we see from other companies in this space, it looks like they’re requiring patients, some at least, to have been on IO for at least 4 months, presumably to select for patients who have acquired IO resistance. So just curious to get your thoughts on whether you think that’s a prudent enrichment strategy going into this post IO setting. And in doing so, does that materially reduce the addressable market size?

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Michael M. Morrissey, Exelixis, Inc. – CEO, President & Director [46]

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Gisela, do you want to take that one?

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Gisela M. Schwab, Exelixis, Inc. – President of Product Development & Medical Affairs and Chief Medical Officer [47]

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Sure. Sure. Yes. I guess the question that you’re asking is one of acquired resistance versus a priori resistance. And there’s, of course, some debate around the prognostic value in that. And so allowing in patients who have had a minimum of 4 months or longer of prior checkpoint inhibitor to treatment suggests that there might be a acquired resistant population, and that population might per se do a little bit better than those who progress right through a checkpoint inhibitor therapy. So I think, of course, we’re still learning about this field day by day. And I’m not sure that the enrichment strategy would go towards a, if you will, worse patient population if you require longer prior treatment durations on checkpoint inhibitors.

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Jason Matthew Gerberry, BofA Merrill Lynch, Research Division – MD in US Equity Research [48]

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Got it. And if I could just squeeze one follow-up in. Just following CheckMate 9ER, not to go back and forth here, but I did. Are you more optimistic about the IO cabo triplet in development after CheckMate 9ER in terms of either your ability to move the needle from an efficacy perspective or just the safety that you’re seeing with the cabo 40-milligram starting dose and how your — how physicians are better at learning how to dose modify?

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Gisela M. Schwab, Exelixis, Inc. – President of Product Development & Medical Affairs and Chief Medical Officer [49]

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Yes. I think we’re very excited about the triplet, most certainly and have been, and the results of CheckMate 9ER, perhaps, if anything, further reinforces that because the opportunity to achieve even more with a 3-drug strategy and what has been seen in the early Phase Ib studies done at the NCI was certainly encouraging.

Regarding the tolerability, I think, certainly, physicians over the time now the checkpoint inhibitors have been available alongside TKI have gotten accustomed to treating patients with these combinations and are well versed in modifying a dose or holding the checkpoint inhibitor and then going in with steroids, if required. So there’s a lot of learning that has occurred there as well, which certainly bodes well for the COSMIC-313 study as well.

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Michael M. Morrissey, Exelixis, Inc. – CEO, President & Director [50]

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Yes. Jason, I would also add just one thing to think about in the context of 313. Remember, both in terms of the CheckMate 214 data as well as how we’re framing and how we wrote the protocol for 313, ipi is given in 4 consecutive cycles. And then it’s essentially the doublet cabo/nivo versus stand-alone nivo as well. So in this kind of quasi maintenance phase. We kind of like that dynamic, too, based upon the 9ER data and potential read-throughs there.

So there’s many different ways to win in terms of not only a more powerful triplet potentially in the early part of that dosing, but also then in terms of a long maintenance phase potentially having cabo/nivo there available, which we think is encouraging based upon the 9ER data.

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Operator [51]

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And your next question comes from the line of Silvan Tuerkcan with Oppenheimer.

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Silvan Can Tuerkcan, Oppenheimer & Co. Inc., Research Division – Associate [52]

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And congrats on the great quarter. My first question is, how would you view the second-line cabo monotherapy use evolve once cabo/nivo is launched in front line is? And basically, is cabo second line OS benefit here key for it to continue being the preferred choice of TKI post failure?

And secondly, could you tell us a little bit more about your adjuvant therapy efforts in renal cell carcinoma? Is there a path forward? And what will be the timing here?

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Patrick J. Haley, Exelixis, Inc. – EVP of Commercial [53]

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Yes. Silvan, thanks for the question. This is P.J. I’ll talk about the second-line dynamic and then perhaps pass it to Gisela to comment on adjuvant. But basically, I think what we’ve been talking about a while with the second-line dynamic and the growth we’re now seeing in terms of new patient share of 45%, that’s really taken years to sort of play out with those patient kinetics in terms of — if you think about the timing and approval of pem-axi and nivo, it would be over years. So those patients, many of them are already on therapy, right, on ICI combo therapy and are going to continue to flow into second line for years to come.

With regards to 9ER, obviously, pending regulatory time lines, we’ll have the opportunity to get approved in the first-line setting and then grow market share and duration there. But I really think at the same time, and you asked an astute question, is the second-line market could continue to grow because of the patient dynamics for some time. So in a sense, could certainly be a possibility where we’re growing in the first line and the second line in RCC, a combination in monotherapy, respectively, which really reinforces the cabo position with all of our studies and data in RCC and being the TKI of choice, both now and moving forward for many years to come.

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Michael M. Morrissey, Exelixis, Inc. – CEO, President & Director [54]

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Yes. We’ve — this is Mike. We’ve talked about this vision where, based upon the totality of the data, we’d like to be able to see every patient who has renal cancer be able to benefit from cabo at some point in their journey from first line to second line to third line. And I think the way P.J. framed it, and certainly the powerful data we have with 9ER and the body of data we have in the second line, really makes that a possibility for us to meet that vision head on.

So we have a lot of work to do yet, but certainly, that’s the direction that we’re working towards as we go forward.

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Silvan Can Tuerkcan, Oppenheimer & Co. Inc., Research Division – Associate [55]

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And then just on the — if you have any plans for adjuvant therapy and what the timing there would be.

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Michael M. Morrissey, Exelixis, Inc. – CEO, President & Director [56]

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Yes. Gisela, do you want to address that, please?

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Gisela M. Schwab, Exelixis, Inc. – President of Product Development & Medical Affairs and Chief Medical Officer [57]

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Sure. Yes, at the current time, we don’t have an adjuvant trial ongoing for cabozantinib in RCC. They have in the context of ISTs a new adjuvant approaches as we’re looking at, and advise going forward eventually. And certainly, we are interested in this space. It is a long-term proposition, of course. And so there may be some opportunity at some point for 092 to play in that space as well. So stay tuned, I would say.

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Operator [58]

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

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Kennen B. MacKay, RBC Capital Markets, Research Division – MD & Co-Head of US Biotechnology Research [59]

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Obviously, there is something special through cabo’s combinations with immune checkpoint, maybe additive, if not perhaps synergistic benefit there, as was tossed around ASCO GU back in what feels like a former life when in-person meetings were happening. I’d love to get your current thoughts around this. Is this additive or really sort of potentially synergistic, especially as we think about prostate cancer where atezolizumab on its own didn’t see really any responses to speak of and has since been discontinued as a monotherapy?

And then 2 quick follow-up on lung cancer as well.

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Michael M. Morrissey, Exelixis, Inc. – CEO, President & Director [60]

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Yes. Thanks for the question. We banter about the S word, synergy, all the time. Maybe Peter could speak to that briefly at a high level. Peter, do you want to…

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Peter Lamb, Exelixis, Inc. – Executive VP of Scientific Strategy & Chief Scientific Officer [61]

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Yes. I mean, I think what I’ll do is essentially just reiterate why we’re excited from a scientific rationale point of view about cabozantinib combinations with checkpoint inhibitors and then why this is then leading to the clinical data that we’re starting to see.

I mean, obviously, it comes down to the cabozantinib target profile and the impact that it has on the tumor microenvironment. If you look at MET, AXL, VEGFR, they play important roles in the regulation of a variety of immune cell subsets, and that includes activation of CD8-positive T cells, and we also have some data showing activation of NK cells as well as inhibition of variety of immunosuppressor cells like Tregs and MDSCs, which we’ve seen, at least peripherally, on a number of clinical trials and certainly preclinically.

So I think if that totality of that profile where we have impacts directly on the tumor and we have impacts on both the adaptive and innate immune system, that’s really feeding into the clinical data that’s emerging and most strikingly in the 9ER data.

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Kennen B. MacKay, RBC Capital Markets, Research Division – MD & Co-Head of US Biotechnology Research [62]

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And then maybe the follow-up on lung cancer. Obviously, you saw the COSMIC-021 lung title at ASCO. Again, just hoping to maybe understand a little bit what you see as sort of the clinical bar for these patients or similar patients, were they to get standard of care chemotherapy. And then similarly, hoping to understand a little bit how you are thinking about the patient population of [CONTACT-01. Is that sort of going to be the same as this expansion of COSMIC-021 or maybe considering a different subpopulation of the non-small cell lung cancer space?

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Gisela M. Schwab, Exelixis, Inc. – President of Product Development & Medical Affairs and Chief Medical Officer [63]

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Sure. Well, as we discussed a little bit earlier on, there are a number of benchmarks out there. You mentioned chemotherapy or chemotherapy plus ramucirumab or other combinations. And in general, I think the benchmark is sort of in the framework of halfway between 10% and 20% or something like that, for the response rate, and it’s not a particularly long-lived response. But I think, of course, you can look at all these data points yourself and make up your mind there.

Regarding the patient population that we’re looking at in 021, we’re requiring the population to have received checkpoint inhibitor prior the normal combination or subsequent to chemotherapy. And in broad brush strokes, it will be a similar patient population in the context of 2 specifics will certainly appear on clinical trials when ready. And I won’t steal the thunder here and let that be rolled out when the time comes.

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Operator [64]

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Your next question comes from the line of Stephen Willey with Stifel.

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Stephen Douglas Willey, Stifel, Nicolaus & Company, Incorporated, Research Division – Director [65]

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I hopped on a little late, So my apologies if I’m repeating anything here. But just with respect to CONTACT-02, the Phase III in prostate, can you maybe just talk about when we might get a little bit of insight into what trial design looks like there? And I think you were asked an ambassador question previously. And just curious as to how you’re thinking about the selection of a control arm at this point. Presumably, you could opt for a novel hormonal like ENZA that hasn’t been used previously, probably have salvage chemo as an option as well and just wondering if you can just kind of walk us through a little bit how you’re thinking about control arm selection and then, specifically, if there’s anything within that ENZA control arm that kind of piques your interest with respect to perhaps selecting it?

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Gisela M. Schwab, Exelixis, Inc. – President of Product Development & Medical Affairs and Chief Medical Officer [66]

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Yes. So this is Gisela. In terms of the treatment that we’re building on, of course, it’s what has been seen at ASCO GU with a strong response rate for the cohort 6 of 32%, generally consistent effect on PSA responses and a good durability of response. So that’s what we’re building on in this patient population as we’re thinking about the Phase III trial.

And there’s a variety, as you mentioned, of opportunities, possibilities in control — regarding control arms. Certainly, novel NHT is amongst them. And it is a choice that many prostate cancer patients value because it would potentially allow them deferral of chemotherapeutic opportunities or options. So that’s certainly a consideration that we’re taking into account when — as when the study will roll out. And I think we’re working on it hard and anticipating moving forward — enrolling forward and being able to speak about it in more detail over this summer.

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Stephen Douglas Willey, Stifel, Nicolaus & Company, Incorporated, Research Division – Director [67]

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Okay. That makes sense. And I guess I agree with your insinuation that an ENZA arm would probably make for easier enrollment. And then maybe just one quick one for P.J. Any change just in general prescribing patterns, I guess, specifically with respect to maybe the number of patients who are getting a script filled greater than 30 days? Or has that remained relatively stable?

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Patrick J. Haley, Exelixis, Inc. – EVP of Commercial [68]

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Yes. I think as we mentioned before, we’re seeing strength in the business, particularly in terms of the second-line new patient share growth. But generally, other metrics remaining relatively consistent with what we’ve seen. We’re certainly pleased with the team there, doing everything they can sort of normally and now in terms of helping patients and our customers with Exelixis Access Services. So we’re continuing to see patients get drug efficiently and certainly gratified by that.

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Stephen Douglas Willey, Stifel, Nicolaus & Company, Incorporated, Research Division – Director [69]

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Great. And congrats on 9ER.

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Gisela M. Schwab, Exelixis, Inc. – President of Product Development & Medical Affairs and Chief Medical Officer [70]

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Thank you.

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Operator [71]

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Your next question comes from the line of George Farmer with BMO Capital Markets.

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George Farmer, BMO Capital Markets Equity Research – Analyst [72]

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I’d like to ask about this backlog that you had talked about at the end of last year with patients that seem to be staying on front line therapy longer and that may have been contributed — contributed to CABOMETYX sales weakness. Are you — do you think we’re through that? And then if so, why not revise guidance given the relatively strong quarter that you just had? And I have a follow-up.

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Patrick J. Haley, Exelixis, Inc. – EVP of Commercial [73]

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Yes. George, this is P.J. I think we have talked about that trend, right, in terms of second-line patients for CABOMETYX being — coming after an ICI combination in the first line. And we saw that sort of stabilize in terms of those kinetics in the latter part of last year, and we really have now seen growth in terms of the number of ICI pretreated patients coming into the second line now where CABOMETYX really captures the majority of those patients where we have the — really the only overall survival benefit as a monotherapy TKI in that setting. And we would anticipate that trend, given the timing of those sort of patient flow kinetics, continuing, frankly. And I think we’re just sort of starting to see the beginning of that in terms of the strength in the second line.

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Christopher J. Senner, Exelixis, Inc. – Executive VP & CFO [74]

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And George, it’s Chris. So on the guidance question, so it is still pretty — it’s early in the year. As P.J. talked about, we had strong second line demand, and that continues to grow. And we also had the inventory build in the quarter that if you back that out, that could — that would reduce the annualized number. And so overall, I’d say we’re squarely in the middle of the guidance range. And that guidance also doesn’t include 9ER. So there’s a lot — and there’s a lot of moving pieces, particularly around the COVID-19 pandemic. So we’re comfortable with where we are right now.

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George Farmer, BMO Capital Markets Equity Research – Analyst [75]

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Okay. And then regarding CONTACT-03, this is your Phase III trial with Roche in RCC, looking at atezo with cabo. I noticed on clinicaltrials.gov that the comparator is cabo alone. Given how this whole field is evolving and it’s getting kind of crowded, certainly, in the front-line setting, do you think cabo is the right comparator in this trial? And is this trial going to be sufficient for regulatory approval?

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Gisela M. Schwab, Exelixis, Inc. – President of Product Development & Medical Affairs and Chief Medical Officer [76]

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Yes. I think what it signals really is that cabozantinib is a standard of care in the second and later line setting in the treatment paradigm of RCC, and I think that’s what the study is building on, evaluating atezolizumab addition on the backbone of cabozantinib. So yes, I do think it’s an appropriate comparative, absolutely. And the study is being designed — has been designed and is being sponsored by Genentech-Roche and certainly done for — with registrational intent.

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Operator [77]

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

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Kyuwon Choi, Goldman Sachs Group Inc., Research Division – Equity Analyst [78]

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My first question is on COSMIC-312. And just given the robustness of the data you saw earlier with CheckMate 040, can you maybe just remind us that if there is an interim built into the trial — interim look built in this year? And is that something that we could possibly see in the back half of the year ahead of the primary completion? Or is the plan to see the trial all the way through to the final result? And then I have a follow-up question on lung.

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Gisela M. Schwab, Exelixis, Inc. – President of Product Development & Medical Affairs and Chief Medical Officer [79]

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Yes. Regarding COSMIC-312, this is an event-driven analysis strategy that underlies the design of the study, and there’s the interim analysis for overall survival at the same time as the primary analysis for progression-free survival built in that would occur first. And then the further analysis for overall survival that would occur, unless the study rejects the (inaudible) hypothesis as one of the earlier ones.

So in terms of the timing, it really is entirely dependent on events. And we’re monitoring events, and we’ll certainly be prepared when the event count — is getting closer.

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Kyuwon Choi, Goldman Sachs Group Inc., Research Division – Equity Analyst [80]

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Okay. And then on the topic of lung, you and your partner, Bristol, have had a trial listed on clinicaltrials.gov, CheckMate 79X for a while, which involves a triple combination of nivolumab, ipilimumab and cabozantinib. And can you maybe just comment on whether the plan is still to kick the trial off this year? And then if the triple combination there proves to have some response, how would you potentially frame that against your ongoing plans for the CONTACT-01 trial, the Phase III trial that you’re planning in the second-line lung indication?

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Gisela M. Schwab, Exelixis, Inc. – President of Product Development & Medical Affairs and Chief Medical Officer [81]

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Sure. Regarding the study 79X LX, this is a trial sponsored by BMS. And the expectation is that the study is kicking off as we speak. And as you said, it’s on clinicaltrials.gov, it’s listed there.

And regarding the second question, everything is data dependent. But certainly, we are moving forward towards initiation. And that is in [Roche] then of CONTACT-02, and you’ll see the first look at the cohort 7 from the COSMIC-021 study at ASCO. So everything is marching forward sort of in parallel at this point.

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Operator [82]

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And your final question comes from the line of Jeff Hung with Morgan Stanley.

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Jeff Hung, Morgan Stanley, Research Division – Equity Analyst [83]

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And congrats on 9ER. Can you talk about your commercial field teams’ experiences with virtual touch points? And if there have been any changes they’ve observed with health care professionals on metrics such as frequency of interactions. And has this improved in recent weeks? I appreciate anything anecdotal you can share. And then I have a follow-up.

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Patrick J. Haley, Exelixis, Inc. – EVP of Commercial [84]

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Yes. Jeff, this is P.J. I guess what I would say about that is we’re certainly pleased with the efforts of the team in supporting the health care providers and the patients appropriately and compliantly.

With regards to what we’ve seen, we have a pretty experienced team, and we feel we have a good sort of yield or conversion from in-person touch points to virtual ones. And I think a lot of that is because of the experience of the team and the fact that this team has been in place for more than 4 years, even seen some secondary research, albeit small ends where we’ve converted more in-person calls to virtual — the most, I should say, in the RCC market. But it’s early. It really is a local-by-local basis and things are obviously dynamic as we’re seeing, and we’re planning on doing everything we can to appropriately support our customers and our patients while maintaining, obviously, vigilance on the health of our employees and all of that as well.

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Jeff Hung, Morgan Stanley, Research Division – Equity Analyst [85]

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Great. And then with substantial safety stock inventories for commercial drug substance and drug products that are sufficient to main supply for a long period of time, can you talk about what kinds of levers you have and what kinds of manufacturing modifications you can make if COVID continues for longer than expected?

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Michael M. Morrissey, Exelixis, Inc. – CEO, President & Director [86]

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Yes. It’s Mike. Yes. Look, we have a very deep, robust supply chain for cabozantinib with various stockpiles of intermediates stored at various region — at various positions and regions in the process. So we have literally years of stock in hand ready to go. So we have really got that covered. That’s a hats off to the CMC and supply team here for really investing in not only the primary supply, but we have a whole secondary supplier — supply chain that’s now coming online for both drug product and drug substance as well to further augment the growing number of indications that we expect in the coming years but also to further reinforce that supply chain.

So a long stability of both API and drug product as well in both the tablet and capsule format. So we’ve got that covered pretty well. Thanks for the question.

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Operator [87]

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

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Susan T. Hubbard, Exelixis, Inc. – EVP of Public Affairs & IR [88]

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Great. Thank you, Nita, and thank you all very much for joining us today. We really appreciate your participation on the call and are standing by to answer any questions that were left unanswered during today’s call. Thanks again. Be safe.

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Operator [89]

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Ladies and gentlemen, this concludes today’s conference. Thank you for your participation, and you have a wonderful day. You may now all disconnect.