Exelixis, Inc. (NASDAQ:EXEL) Q1 2024 Earnings Call Transcript

Exelixis, Inc. (NASDAQ:EXEL) Q1 2024 Earnings Call Transcript April 30, 2024

Exelixis, Inc. misses on earnings expectations. Reported EPS is $0.17 EPS, expectations were $0.28. EXEL isn’t one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).

Operator: Good day, ladies and gentlemen, and welcome to Exelixis First Quarter 2024 Financial Results Conference Call. My name is Towanda and I will be your operator 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 Mr. Varant Shirvanian, Director of Investor Relations. Please proceed.

Varant Shirvanian: Thank you, Tawanda. Thank you all for joining us for the Exelixis First Quarter 2024 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; Amy Peterson, our Chief Medical Officer; and Dana Aftab, our Chief Scientific Officer who together will review our progress for the first quarter 2024 ended March 31st, 2024. 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 Securities and Exchange Commission, 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 costs associated with discovery, product development, business development and commercialization activities.

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

Michael Morrissey: All right. Thanks, Varant, and thanks to everyone for joining us on the call today. Exelixis is off to a strong start in 2024 and had a productive first quarter across all components of our business. We’re pleased to see both revenue and demand growth for the company’s Cabozantinib franchise in the US and globally. Top priority is to move the needle for patients and shareholders by advancing Cabo, Zanza and the rest of our exciting pipeline to improve the standard-of-care for patients with cancer. We have a lot to cover today, so let’s jump right into it with the key highlights for the quarter, including, first, we saw a strong performance of the Cabozantinib business in the first quarter of 2024 with continued growth in demand and revenue year-over-year compared to first quarter of 2023.

Even with typical seasonal headwinds that were further magnified by the implementation of the IRA, CABOMETYX maintained its status as the leading TKI for RCC in both the first-line IO TKI market and the second-line monotherapy segment. First quarter 2024 Cabo franchise net product revenues grew 4% year-over-year compared to first quarter 2023. Highlighting its role as a worldwide leading TKI global cabozantinib franchise net product revenues generated by Exelixis and its partners grew approximately 9% year-over-year in the first quarter of 2024 compared to first quarter 2023. As discussed previously, we’re excited about the potential for additional Cabo growth with the new indications on the horizon that P.J. and Amy will discuss shortly. Chris will review our full first quarter 2024 financial results in his prepared remarks.

Second, we continue to advance our industry-leading pipeline across all stages of preclinical and clinical development. Our top priorities for 2024 are to advance potential new Cabo indications for NET and metastatic CRPC and expedite Zanza clinical development with both existing and new pivotal trials as well as potential new combination strategies. XB002 cohort expansion remains a clear focus for us and XL309 continues to generate exciting momentum in the synthetic lethality space. Finally, we’re thrilled with our progress in advancing new candidates in discovery and preclinical development, targeting a range of solid tumor indications that comprise an IND pipeline of both small molecules and biotherapeutics, which we expect to evolve quickly over the next several years.

Third, final reply briefs for the second MSN ANDA trial were submitted in February and we continue to expect a ruling in the first half of 2024. While we will not speak to any specifics today, this remains a critical milestone for the company and the Cabozantinib franchise. Exelixis will continue to vigorously protect our intellectual property rights with respect to Cabo and our other differentiated molecules we pursue on behalf of patients with cancer. Finally, fourth, we expect business development activities to ramp up significantly as we gain clarity on the outcome of the patent litigation. Importantly, we’re exploring options to collaborate with other organizations in cost and compound sharing arrangements in a manner similar to our prior Cabozantinib checkpoint combination endeavors.

In addition, we are carefully reviewing the competitive landscape on an enterprise-wide level to identify additional later-stage assets that we believe through our unique Cabozantinib lens fit into our GU and GI oncology-focused drug development and commercialization platform. So with that please see our press release issued an hour ago for our first quarter 2024 financial results and an extensive list of key corporate milestones achieved in the quarter. I’ll now turn the call over to Chris.

Christopher Senner: Thanks, Mike. For the first quarter of 2024, the company reported total revenues of approximately $425 million. which included Cabozantinib franchise net product revenues of $378.5 million. CABOMETYX net product revenues were $376.4 million and included approximately $6 million in clinical trial sales. Gross to net for the Cabozantinib franchise in the first quarter of 2024 was 32.9%, which is higher than the gross to net we experienced in the fourth quarter of 2023, but overall, in line with our expectations. This increase in gross to net deductions in the first quarter of 2024 is primarily related to higher Medicare Part D and PHS expenses. Historically, we have experienced higher Medicare Part D expenses in the first quarter of the year due to many Part D patients moving through the donut hole at the start of the calendar year.

Our CABOMETYX trade inventory decreased by approximately 350 units when compared to the fourth quarter of 2023 of approximately 2.4 weeks on hand. As I mentioned on our fourth quarter earnings conference call, we experienced a trade inventory build in the fourth quarter of 2023 of approximately 1,000 units and that we had observed an inventory drawdown in January. As discussed previously, Exelixis took a 2.2% price increase on January 1, 2024. This price increase is more than offset by the higher gross to net deductions during the first quarter of 2024. Also, while we don’t provide quarterly revenue guidance, we do see some seasonality in net product revenue trends, where first quarter net product revenues have historically been lower than the following quarters in a year.

If you analyze the last seven years of first quarter net product revenue and compare them to the reported annual net product revenues of the same year, in many of those years, the first quarter net product revenues are in the range of 21% to 23% of our annual net product revenues. We took this seasonality impact into account when preparing our annual net product revenue guidance of $1.65 billion to $1.75 billion, which we are reiterating on today’s call. As a reminder, clinical trial sales have historically been choppy between quarters and we expect this to continue in future quarters. Total revenues also included approximately $47 million in collaboration revenues, including approximately $40 million of royalty earned from Ipsen and Takeda on their sales of Cabozantinib in their territories.

Our total operating expenses, excluding restructuring charges for the first quarter of 2024 were approximately $363 million compared to $398 million in the fourth quarter of 2023. The sequential decrease in these operating expenses was primarily driven by lower drug discovery and general and administrative expenses in the first quarter of 2024. In January 2024, we announced the restructuring of our business, which included a headcount reduction of 174 FTEs. The total cost of this restructuring in the first quarter of 2024 were approximately $33 million, which include severance and employee-related costs, asset impairment and contract termination costs. Provision for income taxes for the first quarter of 2024 was approximately $12 million, compared to a provision for income taxes of approximately $18 million for the fourth quarter of 2023.

The company reported GAAP net income of approximately $37 million or $0.12 per share on a fully diluted basis for the first quarter 2024. The company also reported non-GAAP net income of approximately $52 million or $0.17 per share on a fully diluted basis. Non-GAAP net income excludes the impact of approximately $50 million of stock-based compensation expense net of the related income tax effect. Cash and investments for the quarter ended March 31, 2024 was approximately $1.6 billion. During the first quarter of 2024, we repurchased approximately $191 million of Exelixis shares at an average price of $22.8. We remain committed to fully executing on the $450 million share repurchase program we announced in January 2024. Combining the 2023 and 2024 share repurchase program, we will return $1 billion to our shareholders by the end of 2024.

This level of cash and investments supported by our ongoing cash flow from operations provides Exelixis with the flexibility to invest in internal R&D activities to pursue external business development opportunities to expand our pipeline and allows us to return capital to our shareholders through our $450 million share repurchase program. And finally, we are reiterating our full year 2024 financial guidance, which is detailed on Slide 14 of our earnings presentation. And with that I’ll turn the call over to P.J.

P.J. Haley: Thank you, Chris. In the first quarter of 2024, team continued to execute at a high level, which has resulted in CABOMETYX continuing to be the number one prescribed TKI in RCC and second-line HCC. Additionally, CABOMETYX in combination with nivolumab remains the number one TKI plus IO combination in first-line renal cell carcinoma. With regards to prescriptions, CABOMETYX TRx volume grew 4% year-over-year in Q1 2024 relative to Q1 2023. In the same period, the TKI market basket was flat. Furthermore, the business remains strong, both in terms of demand and new patient starts. CABOMETYX continued to perform well in the first quarter from both a marketplace and competitive perspective. CABOMETYX again led the TKI market basket in TRx share at 40%.

As we have discussed previously, the first-line RCC market is extremely competitive. And Q1 was the sixth full quarter in which CABOMETYX plus nivolumab, remain the number one prescribed TKI plus IO combination in first-line RCC. Furthermore, long-term data from the CheckMate -9ER study now with a minimum of four years follow-up was presented at ASCO GU this year and continues to reinforce the leadership position that CABOMETYX has in the RCC marketplace. Looking forward, the commercial team is excited about the positive results from the CABINET trial in neuroendocrine tumors as well as the CONTACT-02 trial in metastatic castration-resistant prostate cancer, which Amy will discuss in some detail. Neuroendocrine tumors comprise a large and heterogeneous patient population.

The patients become metastatic and progress treatment options become limited. The only oral therapy options are sunitinib and everolimus and there has not been an approval in the US for an oral agent in NET since 2016. There is a strong unmet need for new options for patients who have progressed on systemic therapy. There are approximately 8,000 incident second-line plus drug-treatable patients annually in the US. Approximately 20% of these patients are SSTR negative and in lung NETs, that percentage is higher with 40% to 60% being SSTR negative. Most NET patients will receive many lines of therapy, in part due to the more indolent nature of the disease relative to other solid tumors. We have conducted preliminary market research, which reveals that oral therapies account for approximately 50% of the utilization in this market in the second-line plus setting.

The CABINET study had a diverse population, including pancreatic, extra pancreatic and lung NET patients. SSTR positive or negative patients as well as previously treated with Lutathera. Regulatory approval for CABINET would potentially position Cabo to help a broad range of NET patients. Metastatic castration-resistant prostate cancer is a large market with significant unmet medical need, where the primary therapeutic options remain novel hormonal therapy, chemotherapy and radioligand therapy. There is a significant unmet need in this patient population, particularly for patients progressing on an NHT and who wish to delay chemotherapy. Many patients receive an NHT before they become metastatic and castrate-resistant. Cabo plus Atezo represents a potential option for many of these patients with novel mechanisms of action and convenient administration in the metastatic CRPC setting.

Furthermore, the commercial organization would be well positioned to leverage the RCC team infrastructure to achieve synergy in a new GU oncology indication. In summary, regulatory approval in these additional indications with significant unmet need would provide the opportunity for continued growth for CABOMETYX in the coming years. I would also add that the commercial team is extremely excited about the progress in the pipeline particularly Zanzalintinib as we look forward to having another product to help patients with cancer. With that I will turn the call over to Amy.

Amy Peterson: Thanks, P.J. Today, I’ll provide a high level update on our clinical stage pipeline. The team is continuing the momentum across all of the programs we highlighted during our R&D Day last December, with laser focus on execution for the Cabozantinib franchise as well as for our clinical pipeline. Our pipeline is broad, both in terms of modalities and targets, representing a variety of development opportunities, which combined with our robust translational and clinical development capabilities provide an exciting and high potential platform for growth. Today, I’ll share the progress we are making towards executing on our clinical trials across the development pipeline and on our potential regulatory submissions for Cabozantinib.

So let’s start with Cabozantinib and CABINET, which is a Phase III study that evaluated Cabo versus matched placebo in patients with previously treated advanced or metastatic pancreatic or extrapancreatic neuroendocrine tumors, which I’ll refer to as pNET or epNET, respectively. The study was conducted by the Alliance for Clinical Trials in Oncology and Data was presented by Dr. Jennifer Chan at ESMO 2023. The study had two independently powered cohorts, one for pNET and the other for epNET. Notably, the PFS hazard ratio for each cohort strongly favored Cabo with hazard rates of 0.27 and 0.45 in the pNET and epNET populations, respectively. The safety profile of monotherapy Cabo was consistent with its known profile and no new safety signals were identified.

This initial analysis was based on local assessments with limited data available from the blinded independent radiology committee or BIRC. The compelling results triggered an IDMC recommendation and Alliance decision to stop enrollment, unblind the study and allow patients to cross over from placebo to Cabozantinib. The final analysis by BIRC will be shared at a conference later this year and support our intention to file in the coming months. As P.J. mentioned in his section, we are very excited about the potential to bring Cabozantinib to patients with neuroendocrine tumors. The CABINET data are quite impressive and robust and have approved support Cabo as a potential new standard-of-care in a population that is in dire need of effective treatment options.

Turning now to CONTACT-02. Our randomized open-label Phase III study of Cabo plus Atezolizumab versus second novel hormonal therapy or NHT in patients with castration-resistant prostate cancer and measurable extrapelvic soft tissue disease. We believe the data from this study support a favorable risk benefit to patients and our intent to file. Remember, this is a unique study population, given the requirement for measurable disease, which we deliberately chose to ensure a robust assessment of PFS by BIRC. CONTACT had dual primary endpoints of PFS by BIRC and OS. We anticipate having the final OS analysis in the coming months. So what does a dual primary end point mean, it means that for a study to be considered positive from a statistical standpoint, we only have to hit on one of the endpoints.

Dr. Neeraj Agarwal presented the significant and robust PFS results at ASCO GU. The PFS hazard rate in the prespecified PFS population was 0.65 with a p-value equal to 0.0007. So statistically significant, hence a positive study. The PFS hazard rates, median and Kaplan-Meier curves and the ITT population by BIRC were nearly identical to that in the PFS population. This was also true for PFS according to the PCWG3 criteria, which includes bone imaging also assessed by BIRC. A PFS benefit was observed in all subgroups, notably in those with the poorest outcome that is in patients with liver metastases and in patients who’ve already received both an NHT and Docetaxel. At this analysis, OS demonstrated a trend favoring Cabo Atezo. CONTACT-02 enrolled a uniquely aggressive clinical subset of mCRPC.

One that is typically highlighted for having the worst prognosis, which is reflected by the limited activity with second NHT. The toxicities reported with Cabo plus Atezo were higher than those with second NHT and this is not surprising, given NHTs are very well tolerated. Especially in those who have already demonstrated good tolerance to prior NHT and remember, the median duration of prior NHT was one year in CONTACT-02. The tolerability profile Cabo Atezo was consistent with the known tolerability profile of each monotherapy agent and with the doublet from other studies as well as with other approved IO TKI combinations. Putting this together and based on the input we’ve received from many in the GU oncology community from patient advocacy groups and patients we firmly believe these findings represent an acceptable risk benefit profile and we are committed to filing this year.

So there’s quite a lot of excitement with Cabo in 2024, but I’m going to turn now to Zanzalintinib where our excitement continues to grow. Our Phase I studies have multiple expansion cohorts in a variety of tumors and combinations. Data generated from these cohorts has and will continue to support our expanded development for Zanza. At the IKCS Conference and R&D Day last year, Dr. Monty Pal presented promising data with Zanza monotherapy, where compelling and durable responses were observed in 32 patients with treatment-refractory clear cell kidney cancer. All of whom had received prior IO and the majority of whom are 81% have received prior VEGFR-TKIs including 51% who previously received Cabo. The ORRs of 38% in the ITT and of 24% in patients who had received prior Cabo are very encouraging especially given that Zanza shares the target kinase profile of Cabo, but a shorter half-life, which you will hear about in more detail from Dana and which seems to result in differential partitioning into tissues, including tumor tissue, potentially explaining the emerging differentiated activity and tolerability profile.

We’re not the only ones excited about Zanza’s potential. The GU community was very receptive to the data presented at IKCS and discussions around collaboration opportunities are ongoing. Turning now to our pivotal studies. We currently have three Phase III studies with Zanza and we’re evaluating additional pivotal studies, including opportunities for collaboration with other companies. Our most mature study is STELLAR-303. This study will evaluate the combination of Zanza plus atezolizumab versus regorafenib in patients with non-MSI-high non-DMMR metastatic and refractory colorectal cancer. The primary endpoint is OS in the population of patients without liver mets or NLM, followed by an evaluation of OS in the ITT population should OS in the NLM population be statistically significant.

So this is not a dual primary endpoint. The sample size for both NLM and LM patients is capped to ensure adequate number of events in each of these analyses. PI excitement about the potential of this combination, especially in patients without liver mets has resulted in rapid uptick in enrollment and enrollment to the liver met cohort is basically complete. Enrollment to the NLM cohort should be complete in the coming months. STELLAR-304 is our Phase III trial, which compares the combination of Zanza plus nivolumab to sunitinib in patients with previously untreated metastatic non-clear cell kidney cancer. This has dual primary end points of progression-free survival and overall response rate. OS is a secondary endpoint. The probability of success of a study is a key strategic lever when we consider how to prioritize our portfolio.

Given that VEGFR-TKIs work in non-clear cell kidney cancer that TKI IO combos work in non-clear cell kidney cancer that Cabo monotherapy beats sutent in kidney cancer and that Zanza has a best-in-class potential for a VEGFR-TKI. We believe this study has a reasonably high PTS. Investigators are also excited about this combination and enrollment is ongoing in multiple countries. STELLAR-305 is our Phase II/III trial, which will evaluate Zanzalintinib in combination with pembrolizumab versus pembrolizumab alone in patients with untreated PD-L1 expressing advanced or metastatic squamous cell carcinoma of the head and neck. This study was activated late last year, and we are full steam ahead into site activation mode. Given the emerging favorable activity and tolerability profile of Zanza and its mechanism of action that results in an immune permissive environment, we believe this combination of Zanza plus Pembro could result in improved outcomes versus single-agent Pembro and has the potential to offer patients a chemo-free option.

Of course, we are intrigued by the LEAP-010 data. And just as we did with STELLAR-310 will make necessary or appropriate modifications to STELLAR-305 to increase the probability of success. We are always evaluating data from Zanza and Cabo studies emerging data from our competitors and the evolving treatment landscape to inform the design and initiation of the next pivotal studies for Zanza. An asset that we believe has potential for best-in-class as of VEGFR-TKI with commensurate improved activity in patients that ultimately transfer into value for our shareholders. I’ll now briefly touch on our early clinical pipeline assets, XB002 and XL309 before passing the call over to Dana. XB002 is our tissue factor directed antibody drug conjugate incorporating a modified or a statin as a payload.

Enrollment into the cohort expansions in the JEWEL-101 study is robust and as the data matures will allow us to understand the initial benefit risk profile. We will provide updates when we have data maturity. Finally, last and certainly not least, is XL309, which we are very excited about. Dana will talk more on why we remain optimistic about this particular USP1 inhibitor. So in the interest of time, I’ll just state that dose escalation cohorts are enrolling, and we hope to open combination cohorts with PARP inhibition a little later this year. In summary, we’re advancing a robust pipeline of clinical stage molecules, while maximizing the potential benefit to patients from our flagship asset, Cabozantinib, in high unmet medical need indications.

We remain very optimistic about what we can do for patients who despite significant advances still need better treatment options. And with that I’ll turn the call over to Dana.

Dana Aftab: Thanks, Amy, and good afternoon, everyone. Today, I’m giving a brief update on our progress in the first quarter of 2024 toward our goals for preparing for IND filings and for advancing new compounds to development candidate status. And then I’ll wrap up with some preclinical updates on our USP1 inhibitor, XL309, and our next-generation VEGF receptor tyrosine kinase inhibitor, Zanzalintinib. On the IND front, we are making good progress on all of our pre-IND programs and are on track to file up to three this year. The first one we expect to file this year is for XB010, our 5T4 targeted antibody-drug conjugate that carries the cytotoxic anti-tubulin payload MMAE. IND preparation is wrapping up soon, so we expect that one to file around midyear.

The second IND we expect to file this year is for XL495, which is a small molecule inhibitor of PKMYT1 that shows synthetic lethality in the context of increased cyclin E levels, which occurs across a wide range of tumors. IND preparation is progressing and we are on track to also file this one around mid-2024. The third IND we expect to file this year will be for XB628, our bispecific antibody that targets PD-L1 along with NKG2A and displays NK cell engager activity in preclinical models. The GLP Tox study for XP628 is now complete and manufacturing and other activities have us on track for IND filing in the fourth quarter of 2024. Each one of these programs has a solid rationale for generating differentiating data in the clinic. So we’re excited to get these INDs filed and to get the trials up and enrolling quickly.

In terms of new development candidates this year, we are currently on track to achieve our goals of at least two this year with some exciting new programs, including a small molecule inhibitor targeting PLK4, which is synthetically lethal and cells of amplified TRIM37 and a novel antibody drug conjugate program. Both of these programs represent first or best-in-class approaches with potential to generate differentiating results in the clinic. So we’re certainly pleased that we remain on track for putting these additional assets into the preclinical pipeline this year. So now I’d like to shift gears a bit and describe some exciting preclinical data we generated for two of our small molecules in the clinical pipeline. I’ll start first with a brief update on XL309 and then describe some preclinical data we’ve generated comparing Zanzalintinib and Cabozantinib.

We recently tested the combination of XL309 with the selective PARP-1 inhibitor, saruparib in the preclinical breast cancer xenograft model, MDA-MB-436 in which the BRCA1 gene is mutated. The data we generated with the combination showed that at doses of both compounds that alone showed minimal tumor growth delay when given in combination resulted in very strong tumor regression that persisted for at least a month after dosing has ceased. The other data I’m sharing with you today, I think, will help to shed more light on the underlying basis for an emerging benefit risk profile for Zanzalintinib that appears to be improved compared to Cabozantinib. You may recall that Zanzalintinib retains the target kinase profile of Cabozantinib, but with a PK profile that’s more optimal for dose adjusting to manage tolerability.

And as you just heard from Amy, we’re seeing what appears to be an overall improved benefit risk profile with Zanza with responses in some patients who progressed on Cabo and lower rates of certain AEs with Zanza such as hand-foot syndrome, diarrhea and fatigue. We now have some preclinical data, which we think help to explain these differences between the two molecules. First, we’ve continued to explore potential differences in the biological target profiles of the compounds and both were recently run side by side in the same experiment in a PRISM screen at the Broad Institute. This is a large-scale diverse cancer cell line screen that determines the effects of compounds on cell viability across approximately 900 distinct cell lines representing over 45 cancer subtypes.

The results we got back from the screen showed the compounds were remarkably similar in terms of their ability to impact cell viability, which largely confirms the hypothesis that the key biological target profiles of Cabo and Zanza are essentially the same. Given the similar target profile, we hypothesized that a potential rationale for the improved profile we’re seeing in the clinic with Zanza might be related to differences in tissue drug concentrations between tumors and normal healthy tissue when compared to Cabo. Therefore, we conducted tissue distribution studies in both rats and mice and observed that compared to Cabozantinib, Zanzalintinib showed higher free drug concentrations in tumors and lower free drug concentrations in normal tissues.

This translated to more potent on-target activity for inhibition of MET in tumors by Zanza. These results were a bit surprising as we had not expected such differentials in tissue partitioning between these two molecules, but the results certainly are consistent with and I think help explain the apparently improved benefit risk profile as emerging with Zanza in the clinic. So with that I’ll turn the call back over to Mike.

Michael Morrissey: All right. Thanks, Dana. I will close by highlighting the two long-standing Exelixis executives are retiring after serving our company for nearly two decades. First, Peter Lamb, EVP of Scientific Strategy was with Exelixis for nearly 25 years. And as you all know, made an outsized impact on our drug discovery efforts during his tenure at the organization. Additionally, Laura Dillard, our EVP of Human Resources, spent nearly 20 years leading our HR efforts to ensure we are keeping pace with the evolution and growth of the company. On behalf of the entire Exelixis team, I’d like to thank both Peter and Laura for their friendship, dedication to Exelixis and most importantly, commitment to cancer patients on a global level.

We wish them all the best as they start their retirement. So with that, I want to thank the entire EXEL team for their efforts to support our discovery development and commercial activities. We’re off to a great start in 2024 and expect this year to be critical for our science and the patients we hope to serve in the future. We built and are constantly fortifying Exelixis as a big small company with all that we do every hour of every day. The Exelixis team is highly motivated to exceed expectations and our mission to help cancer patients recover stronger and live longer. We look forward to updating you on our progress in the future and thank you for your continued support and interest in Exelixis and we’re happy to now open the call for questions.

Operator: Thank you. [Operator Instructions] Our first question comes from the line of Joe Catanzaro with Pipa Sandler. Your line is open.

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Q&A Session

Joseph Catanzaro: Yeah, hi, thanks for taking my question, and appreciate you taking the time here. So I’m wondering if you could elaborate a bit on your earlier comments in the events of a positive outcome with regards to MSN patent litigation and sort of interest in looking for later-stage assets in GU, GI, oncology. I guess, how would you define later stage? Is this sort of modality agnostic? And what size deal do you think you could execute with the balance sheet and clarity around the Cabo revenue tail? Thanks.

Michael Morrissey: Yes, Joe, it’s Mike. Thanks for the question. Yes, this isn’t really a new approach. We talked about this earlier in the year as we were implementing the restructuring focusing our BD efforts on later-stage assets in terms of new modalities that are either in or entering pivotal trials as well as their focus on helping us find collaborations with Zanza and other molecules in our pipeline to collaborate on in terms of cost and/or compound sharing arrangements. So, look, we’re very interested in building a pipeline. We’ve got a great discovery, development and commercial organization and late-stage assets fit well into that overall approach, whether they be already in pivotal trials are about to enter. We think we can add a lot of value as we go forward.

So wouldn’t want to comment on size, wouldn’t want to comment and certainly on individual targets. We’re modality agnostic in terms of small molecules and biologics. We have, I think, a very good eye for good data and good compounds. Again, the Cabo lens, if you will, really informs that. We talked about that at R&D Day back in December. So we’re all in, in terms of finding potential assets to be able to bring into our pipeline and that will continue as we go forward.

Operator: Thank you. Please standby for our next question. Our next question comes from the line of Jason Gerberry with Bank of America. Your line is open.

Jason Gerberry: Hey, guys. Thanks for taking my question. So mine I just wanted to follow up on the any key commercial opportunity slide. I’m just curious how you guys think an indication like that could ramp. The second line incidence, it’s a decent-sized number. I just wonder about the availability of an established oral TKI, which wasn’t studied head-to-head against, if that creates a barrier at all or might slow the launch versus the launches we’re accustomed to seeing like CheckMate -9ER just given the need to potentially retrain physicians or educate them about your data? Thanks.

P.J. Haley: Yes. Hi, Jason. This is P.J. Thanks for the question. I’d say we’re really excited about the data that Amy went into a little more detail on. As I mentioned, we’ve kind of conducted some preliminary market research. We’ve certainly had some advisory boards. I guess what I’d say at a high level is there’s a lot of enthusiasm for the data. I don’t think there’ll be anything significantly different than prior launches. You mentioned 9ER in terms of kind of trajectory or uptake or sort of retraining physicians per se. I think they’re very comfortable, obviously, with TKIs and even in this setting. So we think this is a really nice opportunity potentially should we receive approval. For Cabo, as I spoke to, I think the broad population that was studied with regards to pancreatic, extra pancreatic, site of origin, tumors, including lung, which is a little bit different from some of the other agents, which weren’t studied as broadly as well as the fact that were studied in SSTR positive negative as well as kind of having a modern data set, which included a lot of patients treated with Lutathera before the study really gives us the potential to be broad and I think, in a sense, very user-friendly for oncologists who are really looking for something new in this setting.

Operator: Thank you. Please standby for our next question. Our next question comes from the line of Michael Schmidt of Guggenheim. Your line is open.

Michael Schmidt: Hey, guys. Thanks for taking my questions. I had one for Amy on STELLAR-305. And so just wondering how the enrollment criteria in the study compared to that from KEYNOTE-048 or LEAP-010. And to what degree you feel like you may need to adjust the trial based on the LEAP-010 data that was presented recently? And what your confidence level is in demonstrating a positive overall survival trend, which was obviously not the case in LEAP-010. Thanks so much.

Amy Peterson: Yes. Thanks for the question, Michael. It was very interesting to actually get a chance to see the final — the results from the presentation earlier this year in terms of LEAP-010. Notably an ORR and a PFS that favored LEN/PEM, but an OS that didn’t. And an interesting duration of response with monotherapy PEM favored over the doublet. So this is a different population, frontline head and neck a little bit more frail, than other patient populations. And we’re interested in trying to uncover as much as we can. Around the dose of LEN, the dose reductions and how much that may have aggregated a patient’s ability to receive full Pembro dose. So we are busy deeply trying to understand that and if need be make a change to the 305 study with regard to dose in the context of very a frailer patient population, if you will.

I think that there’s a differentiation between Zanza and LEN in that Zanza does inhibit the TAM kinase family, which is implicated, if you will, in favoring an immune permissive environment. So the mechanism of action of Zanza is different from LEN. And because of that could very likely have a differential outcome and we believe it will. So we’ll see how — what ultimately needs to be changed and we’ll keep you posted on those changes as they’re made. Right now the eligibility criteria for the most part are posted on clinicaltrials.gov. And where we need to make an update, we will.