Q2 2020 Exelixis Inc Earnings Call

And welcome to the Exelixis second quarter 2020 financial results Conference call. My name is GGP and I'll be your operator for today as a reminder, this call is being recorded for replay purposes, I wouldn't like to turn the call over to your host for today Ms., Susan Hubbard Executive Vice President of Public Affairs and Investor Relations. Please proceed.

Operator: Exelixis Second Quarter 2020 Financial Results Conference Call. My name is Gigi, and I'll be your operator for today. As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to your host for today, Ms. Susan Hubbard, Executive Vice President of Public Affairs and Investor Relations. Please proceed.

Thank you T.D. and thank you all for joining us for the Exelixis second quarter 2020 financial results Conference call.

Susan T. Hubbard: Thank you, Gigi, and thank you all for joining us for the Exelixis second quarter 2020 financial results conference call. Joining me on today's call are Mike Morrissey, our President and CEO, Chris Senner, our Chief Financial Officer, Diesel Schwab, our Chief Medical Officer, Peter Lamb, our Chief Scientific Officer, and PJ Haley, our Executive Vice President of Commercial, who will together review our corporate financial, commercial, and development progress for the second quarter of 2020 and June 30, 2020.

Joining me on today's call or Mike, we're seeing our president and CEO, Chris Center, our Chief Financial Officer. He says Schwab, our Chief Medical Officer, Peter Lamb, Our Chief Scientific officer in PJ, Haley or executive Vice President of commercial well together review, our corporate financial commercial development progress for the second quarter 2000.

20, and at June Thirtyth 2020 during the call today, we will refer to financial measures not calculated according to generally accepted accounting principle.

Susan T. Hubbard: 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, as well as the impact of the COVID-19 pandemic on Exelixis' business operations. Actual events or results could, of course, differ materially. We refer you to the documents we file from time to time with the SEC, which, under the heading Risk Factors, identify important factors that could cause actual results to differ materially from those expressed by the company verbally and in writing today, including, without limitation, risks and uncertainties related to product commercial success, market competition, regulatory review and approval processes, conducting clinical trials, compliance with applicable regulatory requirements, our dependence Now, with that, I'll turn the call over to Mike.

Please refer to today's press release, which is posted on their website for an explanation of our reasons for using such non-GAAP measures as well as tables driving these measures from our GAAP results.

During the course of the 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 strategic matters as well as the impact of the Koeppen 19 pandemic Exelixis business operation.

Actual events or results could of course differ materially we refer you to the documents we file from time to time with the FCC, which under the heading risk factors identify important factors that could cause actual results to differ materially from those expressed by the company firmly and in writing today, including without limitation risks and uncertainties related to product commercial.

So market competition regulatory review and approval process. These conducting clinical trials compliance with applicable regulatory requirements are dependent on collaboration partners and the level of costs associated with the discovery product development business development and commercialization activities.

That I'll turn the call over to Mike Alright, Thank you Susan and thanks to everyone for joining us on the call today Exelixis had a strong second quarter across all components of our business. We continue to execute on key priorities and achieved important milestones throughout the quarter.

Michael M. Morrissey: All right, thank you, Susan, and thanks to everyone for joining us on the call today. Exelixis had a strong second quarter across all components of our business.

Michael M. Morrissey: We continued to execute on key priorities and achieve important milestones throughout the quarter. We use today's call to highlight our progress and provide additional perspective for the rest of 2020 as we build off the momentum from the first half of the year. As in recent calls, we'll keep our prepared remarks short and address your questions as the main part of today's update.

When you said, it's called the highlights our progress and provide additional perspective for the rest of 2020 as we build off the momentum from the first half of the here as in recent calls well keep up but probably not short and address your questions as the main part of todays update.

Michael M. Morrissey: Please see our press release that was issued 90 minutes ago for our second quarter 2020 financial results and an extensive list of key corporate accomplishments. The highlight of the quarter was the positive top-line results from CHECKMATE 9ER, the Phase 3 Pivotal Trial evaluating the Cabo Nevo combination in first-line RCC. We're excited to present the detailed results from 9ER at the virtual ESMO meeting in late September. Along with our collaborators, we're on track to complete our high-priority global regulatory filings in the near future. The Exelixis commercial organization will be ready to launch in the United States by the end of August. While first line RRCC remains our top priority as the next commercial growth opportunity for Cabo Zantinib, we've also made important progress in advancing key discovery and development priorities, while we work to expand Cabo's utility in additional indications.

Please see our press release that was issued 90 minutes ago for our second quarter 2020 financial results in an extensive list of key corporate accomplishments.

I would have a quarter was the positive topline results from Checkmate 90 are the phase three pivotal trial evaluating the Cabo Nivo combination in first line RCC. We're excited to present the detailed results from 90 are at the virtual ESMO meeting in late September.

Along with our collaborators we're on track to complete our high priority global regulatory filings in the near future. The Exelixis commercial organization will be ready to launch in the United States by the end of August.

Well first line RCC remains our top priority as the next commercial growth opportunity for Cabozantinib. We've also made important progress in advancing key discovery and development priorities, while we work to expand coppice utility additional oncology indications importantly, three new global phase three pivotal trial.

Michael M. Morrissey: Importantly, three new Global Phase III Pivotal Trials of Cobosantinib in combination with etizolizumab have recently been initiated as part of the CONTACT Clinical Trial Program. The success of Checkmate 90R, coupled with the data presented this year at various ASCO meetings for CABO-IO combinations in liver, prostate, lung, and bladder cancers, highlight the important role CABO's Antidote can play as These early signals of compelling efficacy and tolerability may provide potential encouraging read-through for current pivotal trials in new indications. Finally, we're on track to file up to three new INDs by the end of this year as a result of our internal efforts and the work of our partners. I'm incredibly proud of the commitment and focus displayed by the entire Exelixis team as we continue to drive our business forward during these challenging times. So with that, I'll turn the call over to Chris, who will provide an update on our second quarter financial results.

As of Cabo San to move in combination with because it wasn't MEP have recently been initiated as part of the contact clinical trial program.

The success of Checkmate 90, our coupled with the data presented this year at various ESCO meetings for cobble I accommodations in liver prostate lung and bladder cancers highlight the important role cobble sensitive can play as a unique and differentiated PK I backbone.

These early signals is compelling efficacy and Tolerability may provide potential encouraging read through the current pivotal trials in new indications.

Finally, we're on track to file up to three new why Andy's by the end of this year as a result at our internal efforts and the work of our partners I'm incredibly proud of the commitment and focus displayed by the entire Exelixis team as we continue to drive our business forward. During these challenging times, so with that I'll turn the call over to Chris will provide.

An update on our second quarter financial results. Thanks, Mike for the second quarter 2020. The company reported total revenues of $259.5 billion total revenues for the quarter included Cabo sensitive franchise net product revenues of $178.7 million.

Christopher J. Senner: Thanks, Mike. For the second quarter of 2020, the company reported total revenues of $259.5 million. Total revenues for the quarter included Cabo Sanctity franchise net product revenues of $178.7 million; net product revenues in the second quarter of 2020 were negatively impacted by the COVID-19 pandemic and by a general reversal of the inventory built by wholesalers and customers in the first quarter of 2020. Total revenues also included $80.7 million in collaboration revenues from Ipsen, Takeda, and Genentech. Our total operating expenses R&D expense was the primary driver of the increase in total operating expenses, which increased by approximately $13 million and was primarily related to an increase in clinical trial expenses as we continue to invest and maximize the full clinical and commercial potential of Cabo Santa. The increase in R&D expenses was partially offset by a decrease in SG&A.

Net product revenues in the second quarter 2020 were negatively impacted by the coven, Nike pandemic and by general reversal, the inventory built by wholesalers and customers in the first quarter 2020.

Total revenues also included $80.7 million in collaboration revenues from Gibson, Takeda and shouldn't tech.

Our total operating expenses for the second quarter 2020, $183.9 million compared to $174.1 billion in the first quarter 2020.

R&D expense was the primary driver of the increase in total operating expenses, which increased by approximately $13 million and was primarily related to increase in clinical trial expenses as it continues events and maximize the both clinical and commercial potential of couple of Stephens.

The increase in our R&D expense was partially offset by decrease in yesterday expenses.

Provision for income taxes for the second quarter, 2020 were $13.9 million and our effective tax rate for the quarter was approximately 17.2%.

Compared to $11.4 million and 19% for the first quarter 2020, the company reported GAAP net income of $66.8 million.21 per share on a fully diluted basis second quarter 2020.

Christopher J. Senner: Provision for income taxes for the second quarter of 2020 was $13.9 million, and our effective tax rate for the quarter was approximately 17.2% compared to $11.4 million in 19% for the first quarter 2020. The company reported a gap net income of $66.8 million, or 21 cents per share on a fully diluted basis for the second quarter of 2020. The company also reported non-gap net income of $79.4 million, or 25 cents per share on a fully diluted basis. Non-gap net income excludes the impact of approximately $12.5 million of stock-based compensation expense net of the related income tax effect.

The company also reported non-GAAP net income of $79.4 billion were 25 cents per share on a fully diluted basis non-GAAP net income.

Excludes the impact of approximately $12.5 million of stock based compensation expense no other related income tax effect.

Cash investments increased by approximately 100 million $100 million during the quarter ended June Thirtyth 2020 to over $1.5 billion now turning to our fiscal year 2020 financial guidance.

Well, we recognize the impact of Kobe T. pandemic is both fluid and difficult to predict we have been able to continue the ex executing on our corporate goals and therefore.

Christopher J. Senner: Cash Investments increased by approximately $100 million during the quarter ended June 30, 2020, to over $1.5 billion. Now turning to our Fiscal Year 2020 Financial Guidelines. While we recognize the impact of the COVID-19 pandemic is both fluid and difficult to predict, we have been able to continue to execute on our corporate goals.

We are updating the financial guidance, we provided earlier this year, we're increasing our total revenue guidance, which we expect to be in the range of 909 hundred $50 million due to higher milestones in R&D reimbursement revenues.

Net product revenues or expect to be in the range of 725 and $775 million.

Cost of goods sold is expected to be between four or 5% of net product revenues research and development expenses or increasing due primarily to higher forecasted licensing expenses and I expect to be in the range of $500 million to $550 million.

Christopher J. Senner: And therefore, we are updating the financial guidance we provided earlier this year. We are increasing our total revenue guidance, which we expect to be in the range of $900 and $950 million due to higher milestones in R&D reimbursement revenue. Net product revenues are expected to be in the range of $725 and $775 million. Cost of goods sold is expected to be between 4% and 5% of net product revenues. Research and development expenses are increasing due primarily to higher forecasted licensing expenses and are expected to be in the range of $500 to $550 million, which includes non-cash expenses related to stock-based compensation of approximately $25,000. Selling General Administrative Expenses are increasing due primarily to incremental marketing costs supporting the potential 90-year launch and are expected to be in the range of $250 and $270 million, which includes non-cash expenses related to stock-based compensation of Guidance for the effective tax rate in 2020 is decreasing and is now expected to be between 17 and 19%. And finally, we're projecting cash and investments to be in the range of $1.5 and $1.6 billion. This cash and investments guidance does not include the impact of any potential new Business Development Act.

Which includes noncash expenses related to stock based compensation and roughly $25 million.

Selling general administrative expenses are increasing due primarily the incrementals marketing costs supported the potential diniyar launch and I expect to be in the range of 250 $270 million.

This includes noncash expenses related to stock based compensation approximately $40 million.

Guidance for the effective tax rate in 2020 is decreasing and is now expected to be between 17 and 19%.

And finally, we are projecting cash and investments to be in the range of 1.5 and $1.6 billion. This cash in investments guidance does not include the impact of any potential new business development activities.

With that I'll turn the call over to Gisela.

Thank you Chris I'm pleased to provide an update on our cousins unit regulatory development program and progress you compounds toward find <unk> before handing over to Peter.

I'll start with Checkmate Narnia, we've made a lot of progress since the positive topline results right now in late April but be enough index in Texas.

If you recall the study demonstrated significant benefit over the comparative significant <unk>.

All three efficacy endpoints, including overall survival progression free survival and objective response rate.

Additionally, the combination that's covers Antuna, it's 40 milligram Q D and nibble Yamal generally well tolerated.

We'll see I Didnt know discontinuation break.

On the basis of these are so they have been working very productively with BMS.

And our partners, it's similar chiquita over the last few months launching the regulatory filing.

Gisela: With that, I'll turn the call over to Gisela.

Gisela: Thank you, Chris. I'm pleased to provide an update on our carboxyantinib regulatory and development program and progress of new compounds toward IND before handing over to Peter. I'll start with Checkmate 9ER.

I'm happy to say that'd be very close to completing all activity towards the supplemental NDA filing for the combination of comes down to nipping nibbling him up within the first line treatment to philosophy.

It's finding is intended to upper concurrently with BMS is finding its DNA.

Gisela: We've made a lot of progress since the positive top-line results were announced in late April by DMS and Exelixis. As you recall, this study demonstrated a significant benefit over the comparative synetinib for all three efficacy endpoints, including overall survival, progression-free survival, and objective response rate. Additionally, the combination of carbazantinib at 40 mg QD and nivolumab was generally well tolerated and associated with a low discontinuation rate. On the basis of these results, we have been working very productively with the BMS team and our partners at Ibsen and Takeda over the last few months on advancing the regulatory process, and I'm happy to say that we are very close to completing all activities The filing is intended to occur concurrently with BMS's filing of the SDLA. We are also looking forward to the presentation of the detailed results of the study and the presidential symposium. The upcoming virtual ESMO conference in late September 2020.

Yeah also looking forward to it to the presentation detailed results from this study and the presidential symposium.

Yep coming virtual conference in May.

But you're talking 20.

Besides the progress on check Mcdonie, our ongoing phase three program focuses on to it because also make rapid Parker.

Despite the modest in picked an hour study from the cold pandemic with temporary slowing of screening and enrollment of patients in March and April.

That's continued our fishing execution of the cosmic study.

And have also been able to start the contract phase three program genetic watch.

Regarding all cosmic trials cosmic 311, the phase three study and our <unk> refractory differentiated aside cancer.

It's enrollment milestone of 100 to patients in February 2020.

And we are looking forward to the planned analysis of the co primary endpoints objective response rate in the second half Twentytwenty.

Additionally, enrollment continues into the plant completion of 300 patients.

To support the other primary endpoint progression free survival.

Gisela: Besides the progress on CHECKMATE-9ER, the ongoing Phase III program for Khabazan Teneb has also made rapid progress. Despite the modest impact on our studies from the COVID pandemic, with temporary slowing of screening and enrollment of patients in March and April, we have continued our efficient execution of the COSMIC study and have also been able to start up the CONTACT Phase 3 program with Genentech robots. Regarding our COSMIC trials, COSMIC-311, the phase 3 study of RAI refractory differentiated thyroid cancer, reached its enrollment milestone of 100 patients in February of 2020, and we are looking forward to the planned analysis of the co-primary endpoint of objective response rate in the second half of 2020. Additionally, enrollment continues to the planned completion of 300 patients to support the other primary endpoint of progression-free survival.

Further we have completed become global enrollment cosmic three trials.

First line HCC study, comparing cabozantinib and go to the lead them up.

Wrapping it and previously untreated HCC patients.

The only types remaining open for patient screening and enrollment at this time in China, we aim to involve the necessary patient number to enable local registration data providing.

It's enrollment in the main global study completed the steady, but now it's wants to its event driven analyses well involvement in China, it's being executed separately.

Based on current events right, we anticipate achieving the required to ban in May 2020, early 2021, and expect topline analyses to occur in the first half of 2021.

We are tracking eventful bulk PFS for the final PFS analysis.

Oh it for the first interim analysis closely and that blinded fashion and we'll provide more refined guidance once we get closer to the is good number triggering analyses.

Gisela: Further, we have completed the global enrollment of COSMIC 312, our first-line HCC study comparing calbizantinib and atezolizumab with serafinib in previously untreated HCC patients. The only sites remaining open for patient screening and enrollment at this time are in China, where we aim to enroll the necessary patient numbers to enable local registration data provision. With enrollment in the main global study completed, the study will now advance to its event-driven analysis, while enrollment in China is being executed separately. Based on current event rates, we anticipate achieving the required events in late 2020 or early 2021, and expect top-line analyses to occur in the first half of 2021. We are tracking events for both PFS, for the final PFS analysis, and OS, for the planned first interim analysis, closely in a blinded fashion and will provide more refined guidance once we get closer to the event number triggering analysis. And lastly, enrollment in the COSMIC-313 Phase 3 study in previously untreated patients with intermediate or poor-risk RCC continues globally. We expect to complete enrollment in late 2020 or early 2021 and are looking forward to results of the event-driven analyses from the study when available in the 2020-2022 timeframe.

And lastly enrollment in the classic series her team Chris Reed study in previously untreated patients intermediate or poor risk RCC continues globally.

We expect to complete enrollment in May 2020, <unk> early to concentrate keyboard and I'm looking forward to results of the event driven analyses from this study when available and the two nine teacher and teacher timeframe.

Likewise caused me go to one our large phase one be trial of crop is actually up into teaching. These him up continues to make proper.

Importantly, the metastatic CRPC cohort.

Non small cell lung cancer, setting and checkpoint inhibitor pretreated non small cell lung cancer patients.

Yielded encouraging results.

They are presented earlier in the here ill ask would you add basketball.

These results have supported the initiation if all contract phase three program.

And then take wash evaluating tbas and connect entities they need them up in three indication.

All three of the Phase two study has now been initiate it including contract one checkpoint inhibitor pretreated non small cell lung cancer.

Back to normal monotherapy pretreated metastatic CR P.C.

And contract Oaktree and checkpoint inhibitor pretreated renal cell cancer.

Also cosmic go to warn itself, it's made enrollment progress, particularly in metastatic CR P.C. and non small cell lung cancer.

Gisela: Likewise, COSMIC-021, our large Phase 1b trial of carbazantinib and atezolizumab, continues to make progress. Importantly, the metastatic CRPC-COVID-6 and non-small cell lung cancer-COVID-7 and checkpoint inhibitor pretreated non-small cell lung cancer patients have yielded encouraging results that were presented earlier in the year at ASCO-GU and ASCO. These results have supported the initiation of our CONTACT Phase III program with Genentech Roche, evaluating cabozantinib and atezolizumab in three indications. All three of the Phase III studies have now been initiated, including CONTACT-01 in checkpoint inhibitor pretreated non-small cell lung cancer, CONTACT-02 in novel hormonal therapy pretreated metastatic CRPC, and CONTACT-03 in checkpoint inhibitor Also, COSMIC-021 itself has made good involvement progress, particularly in metastatic CRPC and non-small cell lung cancer.

As a reminder, the Medicaid CR P.C. cohort six which is close to completing enrollment.

Can potentially support and accelerated approval Paul as discussed was asking.

It's all dependent upon for that result from cohort C and of the M. CR P.T. cohorts evaluating single agent activity represents unit and occasionally them up to interest contribution of the components of the combination therapy.

Well non small cell lung cancer cohort, Kevin evaluating the combination and checkpoint inhibitor pre treated patients.

And the corresponding single agent count the Docgenix cool.

Also close to completing enrollment in the rating evaluation regarding potential for the expansion.

Looking back on this call to me as well with the progress of the type of Duncan up regulatory and development program and the level of execution by both our two phone team and our clinical partner teams.

Who together have been able to make significant progress.

Gisela: And as a reminder, Medistate CRPC Cohort 6, which is close to completing enrollment, can potentially support an accelerated approval path as discussed with FDA. This will depend upon further results from Cohort 6 and other MCR-PC cohorts evaluating single-agent activity of carbazantinib and atazolizumab to address the contribution of the components of the combination therapy. For non-small cell lung cancer, cohort 7, evaluating the combination in checkpoint inhibitor pretreated patients, and the corresponding single-agent composantion of cohorts, are also close to completing enrollment in the Raging Evaluation regarding potential further expansion. Looking back on this quarter, we are thrilled with the progress of the Kabadon Chinook Regulatory and Development Program and the level of execution by both our own teams and our clinical partner teams, who together have been able to make significant progress. Despite challenging times and conditions around the world due to the global pandemic,

Like the challenging times and conditions around the world due to the global pandemic.

Likewise, they're making good progress on various I'd, enabling efforts as well as the itself will not to program.

For example on on two we expect to start evaluation of the combination with checkpoint inhibitors in coming months.

In Htwo I.M.D. candidates, we're working towards our energy mining.

The engine here and Peter will go into more detail on these programs in a few moments.

And finally, we are looking forward to the cup events <unk> presentation before conferences.

Especially as small and will include datasets and can you fill RCC and non clear cell RCC from causing to go to one.

And well it's of course importantly, checkmate <unk>.

And to close I'd like to provide a quick regulatory update koby matching it.

At the end of July 20, Trenching FDA approved the supplemental biologics license application so much inflation metric.

Gisela: Likewise, we are making good progress on various IND enabling efforts, as well as the Excel 092 program. For XL092, we expect to start evaluation of the combination with checkpoint inhibitors in the coming months. And for our IND candidates, we are working towards IND planning before the end of the year. And Peter will go into more detail on these programs in a few moments. And finally, we are looking forward to the Kobzantzian presentations at the fall conference, especially ESMO, which will include datasets in ClearCell RCC and non-ClearCell RCC from COSMIC-021, as well as, of course, importantly, Checkmate NYAR.

A teaser leads him up that's probably much of it and then year often it for the treatment of few BRAF Vsix Hundrede mutation positive advanced melanoma and previously untreated patients.

The approval, it's based on positive results from inspire 150.

Phase three pivotal trial demonstrated that adding attendees them up to koby matching it and me of off and that's helped to reduce the risk 50 seats worsening or death.

Peer to peer people, that's probably matching up and then you're asking.

This is the second F.D.A. pool for regimen containing a coffee, making it which we discovered and that is being developed by Genentech. It's part of it world wide collaboration agreement between the two companies.

And with that I will hand, the call the teacher.

Gisela: And to close, I'd like to provide a quick regulatory update on Covumetinib. At the end of July 2020, the FDA approved the Supplemental Biologics License application submitted by Schneemke for atezolizumab plus cubimetinib and vermirafenib for the treatment of BRAF B600 mutation-positive advanced melanoma in previously untreated patients. The approval is based on positive results from IMSPIRE 150, a phase three pivotal trial that demonstrated that adding atazolizumab to covimetinib and vermurafenib helped to reduce the risk of disease worsening or death compared to placebo plus covimetinib and vermurafenib. This is the second FDA approval for a regimen containing Covimagenib, which we discovered and which is being developed by Genentech as part of a worldwide collaboration agreement between the two companies.

Thank you Gisela.

I'm happy to provide a brief update on preclinical development and pipeline expansion efforts.

First off to a three month hiatus due to cope with 19 Weve, partially we didn't work out on discovery Liberal treason Alameda following stringent protocols to protect our employees.

It's exciting to see the flow of data resumed once again, making progress on all early stage discovery program I'd like to take this opportunity to thank all of the discovery team members for making this happen.

Look at our partners, particularly in Venrock Aurigene, an iconic has continues to advance as house preclinical development.

Okay.

As a result, we now have the opportunity to file up to four studies in the next nine month.

As previously discussed we may fall up to three of these studies this year.

CDK seven inhibitor from Orijin collaboration.

Peter: And with that, I will hand the call over to Peter.

Peter: Thank you, Gisela. I'm happy to provide a brief update on our pre-clinical development and pipeline expansion. First, after a three-month hiatus due to COVID-19, we have partially resumed work at our Discovery Laboratories in Alameda, following stringent protocols to protect our employees. It's exciting to see the flow of data resume, and we are once again making progress on our early stage discovery programs. And I'd like to take this opportunity to thank all of the discovery team members for making this happen.

I'm kind of focus Teekay <unk> X L 265 from our internal abroad trees.

If you factor targeting antibody drug conjugate from all iconic collaboration.

We have now advancing additional compound from Aurigene with a novel mechanism of action into preclinical development, which could provide additional R&D in the first half of next year.

With respect to potential upcoming presentations, we plan to present data on XL I'm going to next generation that they just from an EBITDA that is currently in phase one trials later this year.

Peter: Work at our partners, particularly Invenra, Origin, and Iconic, continues to advance, as has preclinical development work at our network of CROs. As a result, we now have the opportunity to file up to four INDs in the next nine months. As previously discussed, we may file up to three of these INDs this year.

We also plan to present data on three about preclinical assets. It's fine talk scientific conferences later this year, specifically the CDK seven inhibitor the tissue fact, HBC and I'll lead program with invent which is a bi specific antibody targeting PDL one CD 47.

Peter: CDK7 inhibitor from our Origin Collaboration, a TAM kinase focused TKI XL265 from our internal laboratories, and a tissue factor targeting antibody drug conjugate from our Iconic Collaboration. We have now advanced an additional compound from AuraGene with a novel mechanism of action into preclinical development, which could provide an additional IND in the first half of next year. With respect to potential upcoming presentations, we plan to present data on XL092, our next generation MET VEGFR inhibitor that is currently in Phase I trials later this year. We also plan to present data on three of our pre-clinical assets at scientific conferences later this year, specifically the CDK7 inhibitor, the tissue factor ADC, and our lead program with Invenra, which is a bispecific antibody targeting PD-L1 and CD47

Well be happy to provide more details as we get clarity on abstract acceptance.

We've had a very busy quarter from a <unk> business development perspective can have a number of advancing discussions.

We continue to assess opportunities in both the small molecule and biologic space, which we find scientifically compelling and where we see a clear path forward for us to effectively develop and commercialize with an emphasis on clinical need clinical stage programs.

In addition, we're exploring a variety of platforms that have the potential to provide a flow of novel therapeutics going forward on the compliments, our internal discovery capabilities.

We look forward to providing additional updates on these BD discussions if they come to fruition.

I don't tend to cool PJ.

Thank you Peter.

I'm pleased to review the commercial performance of Cabometyx for the second quarter 20 Twond.

Couple of mix continues to be the number one prescribed single agent Teekay I in RCC, which is notable in the context of competitive market, which now includes three first line immune checkpoint inhibitor for IC I combinations.

Peter: We'll be happy to provide more details as we get clarity on abstract acceptance. We've had a very busy quarter from a business development perspective and have a number of advanced discussions. We continue to assess opportunities in both the small molecule and biologic space, which we find scientifically compelling and where we see a clear path forward for us to effectively develop and commercialize, with an emphasis on clinical or near-clinical stage programs. In addition, we're exploring a variety of platforms that have the potential to provide a flow of novel therapeutics going forward and that complement our internal discovery capability. We look forward to providing additional updates on these BD discussions as they come to fruition. And with that, I'll turn the call over to PJ.

The business remain largely stable in Q2, despite the cobot 19 pandemic.

As has been the case with other bio pharma companies in Q2, we did see if you trends that we believe reflect the impact of dependent.

Demand decreased modestly in Q2 as a result of dependent and as Chris mentioned inventory was built in Q1 vote by the wholesalers as well as the end customers and this trend generally reversed in Q2.

Also in the weeks following initial shelter in place orders at the beginning of the quarter. There was a decrease in new patient starts on Cabometyx therapy within Nader in May.

This trend reversed in June and has since remains stable.

PJ: Thank you, Peter. I'm pleased to review the commercial performance of Cabo Medics for the second quarter of 2020. Cabo Medix continues to be the number one prescribed single-agent TKI in RCC, which is notable in the context of a competitive market which now includes three first-line immune checkpoint inhibitor, or ICI, combinations. The business remained largely stable in Q2 despite the COVID-19 pandemic. As has been the case with other biopharma companies in Q2, we did see a few trends that we believe reflect the impact of the pandemic. Demand decreased modestly in Q2 as a result of the pandemic.

The impact on new patient prescription dynamics was largely a market phenomenon is it was seen across the market basket.

We believe this may reflect obstacles that pandemic initially created to patients ability to access to health care system.

Nevertheless, with regards to competition in market share, we're pleased with the performance of Cabometyx in Q2.

Market share remain consistent in our key segments in both RCC in HCC.

Cabo Trx share was stable at 30% in Q2 relative to Q1.

Although there was a small declines in the overall teekay <unk> trx market basket in Q2.

Our team continues to be focused on complaint we supported.

PJ: And as Chris mentioned, inventory was built in Q1 both by the wholesalers as well as by the end customers, and this trend generally reversed in Q2. Also, in the weeks following initial shelter-in-place orders at the beginning of the quarter, there was a decrease in new patient starts on KaboMedx therapy, with a nadir in May. However, this trend reversed in June and has since remained stable. The impact on new patient prescription dynamics was largely a market phenomenon, as it was seen across the market basket. We believe this may reflect obstacles that the pandemic initially created to patients' ability to access the health care system.

With care providers, who treat cabometyx patients since the pandemic has taken hold in the U.S.

Throughout the quarter, we did this through virtual speaker programs phone calls and digital tactics. This is maintained our share of voice for cabometyx relative to our competitors.

At the end of the quarter the fuel facing teams were able to resume in person interactions with necessary safety precautions on a limited basis, if appropriate relative to local shelter in place guidance conditions in customer protocols.

In looking to the future of the top as incentive franchise. We're excited by the recent outcome of the Checkmate 90. Our study is we believe these results pending regulatory approval may provide us with the opportunity to grow cabometyx market share and increase duration of therapy in the first line.

PJ: Nevertheless, with regard to competition and market share, we are pleased with the performance of Cabo Medix and Q2. Market share remained consistent in our key segments in both RCC and HCC. Cabo TRX's share was stable at 30% in Q2 relative to Q1. Although there was a small decline in the overall TKI TRX market basket in Q2, Our team continues to be focused on compliantly supporting the health care providers who treat Cabo Medics patients since the pandemic has taken hold in the United States. Throughout the quarter, we did this through virtual speaker programs, phone calls, and digital tax. This has maintained our share of voice for Cabo Medix relative to our competitors. At the end of the quarter, field-facing teams were able to resume in-person interactions with necessary safety precautions on a limited basis, if appropriate, relative to local shelter-in-place guidance, conditions, and customer protocols.

The I.T.I. combination opportunity in the first line setting as large with I see I combination therapy, consisting of approximately 75% of the market share in that setting.

As we have now been in this market for over four years or team has deep knowledge and experience in RCC and again, assuming regulatory approval of the Cabo Knievel combination, we look forward to the opportunity to educate physicians on this data at the appropriate time, so that more patients had the opportunity to benefit from Kabul, Matt.

[noise] therapy in the first line setting.

The feedback that we have received from K wells on the 90, our topline results has been very positive with regards to efficacy safety and Tolerability of the Cobbling you bundling and we're confident in our ability to compete effectively in the first line setting with this data in hand.

Our team is highly motivated and focused on launch preparation and we will be fully launch ready by the end of August.

PJ: In looking to the future of the Cabo Zanthinib franchise, we are excited by the recent outcome of the Checkmate90R study, as we believe that these results, pending regulatory approval, may provide us with the opportunity to grow CaboMedx market share and increase duration of therapy in a first line. The ICI combination opportunity in the first-line setting is large, with ICI combination therapy consisting of approximately 75% of the market share in that setting As we have now been in this market for over four years, our team has deep knowledge and experience of RCC.

At the same time as we launch Cabometyx in combination in first line. There will continue to be patients progressing from I see I'd be therapy in the second one that will be eligible for cabometyx monotherapy.

We currently continue to capture a very high percentage of that patient population and pending regulatory approval for 90 are we believe cabometyx will have great potential to grow in the first line in terms of bull market share and duration, while simultaneously growing monotherapy share in the second one.

With regards to HCC, the U.S. Cabometyx business remained stable.

PJ: And again, assuming regulatory approval of the Cabo Nevo combination, we 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 Cabo Medix therapy in the first-line setting. The feedback that we have received from KOLs on the 9ER top-line results has been very positive with regard to efficacy, safety, and tolerability of the Cabo Nevo doublet, and we are confident in our ability to compete effectively in the first-line setting with this data in mind. Our team is highly motivated and focused on launch preparation, and we will be fully launch ready by the end of August.

As anticipated the combination of a total is enough and Bevacizumab received approval in first line HCC in Q2 early market data show fast uptake of the rent.

The HCC landscape will likely evolve in a similar fashion to what we saw in the RCC market with ice tea 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 one market.

We anticipate this will in turn increased Teekay I monotherapy utilization in the second line setting second line I see I monotherapy use decreases over time.

Turning to a different ICI combination partner, we look forward to further ICI combination data with Cabo and HCC to build on the check people forero data presented earlier this year.

PJ: At the same time as we launch Cobomedics in combination in the first line, there will continue to be patients progressing from ICI-based therapy in the second line that will be eligible for Cobomedics monotherapy. We currently continue to capture a very high percentage of that patient population and are pending regulatory approval for 9-ER. We believe Coblemedics will have great potential to grow in the first line in terms of both market share and duration while simultaneously growing monotherapy share in the second line. With regard to HCC, the U.S. Cabo Medics business remains stable. As anticipated, the combination of tezolizumab and bevacizumab received approval in first-line HCC in Q2, and early market data show fast uptake of the regimen. The HCC landscape will likely evolve in a similar fashion to what we saw in the RCC market.

Cosmic 312 will provide the next phase three read out of Cabometyx in combination with a $10 a map and represents another potential growth opportunity for the franchise.

Additionally, based on the incursion Calhoun sensitive Tesla is about combination data that has been highlighted in recent presentations in CR P.C. and NSCLC.

In previously in RCC longer term growth for Cabo could be driven by the next wave pivotal trials, including the context studies that were recently announced.

Additionally, in first line RCC. The cosmic 313 study investigating the first triplet in RCC Cabo Nivo it'd be has the potential to provide further growth.

This broad development program expands the potential of Cabo to benefit many more patients across different solid tumor malignancies and in multiple IC combinations.

We strongly believe that many more eligible patients could benefit from cabometyx.

Hello, Medix remains the number one prescribed single agent Teekay and RCC and we look forward to building on this momentum in RCC HCC and other potential future indications such as prostate and long as our development program evaluating couples incentive in combination with immune checkpoint inhibitors expands and progressive.

PJ: With ICI combination therapy moving to the front line, it could be an important new standard of care for treatment-naive liver cancer patients and serve to expand the front 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. Turning to a different ICI combination partner, we look forward to further ICI combination data with CABO and HCC to build on the Checkmate 040 data presented earlier this year. Cosmic 312 will provide the next phase 3 readout of Cabo Medix in combination with tezolizumab and represents another potential growth opportunity for the program. Additionally, based on the encouraging Cabozantinib-Atezolizumab combination data that has been highlighted in recent presentations in CRPC and NSCLC and previously in RCC, longer-term growth for CABO could be driven by the next wave of pivotal trials, including the contact studies that were recently announced.

The exciting data from 90 ours. The first of many phase three 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 remains highly focused and motivated to compete everyday bring the benefit of cabometyx to all eligible patients as we continue to build the franchise and maximize its clinical and commercial potential.

With that I'll turn the call back over to Mike Alright, Thanks, PJ as I said in today's intro, we had a strong second quarter and are working to build on the momentum from the first half of 2020 over a range of commercial clinical and discovery opportunities at the same time as we acknowledged on the Q1 coal we recognize the risk tour.

Our business should a pandemic continue to grow in severity as we've certainly seen over the last several months. He will continue to push forward in these challenging times with employee and patient health and safety always our highest priority.

PJ: Additionally, in first-line RCC, the COSMIC 313 study investigating the first triplet in RCC, Cabo Nevo Ipi, has the potential to provide further growth. This broad development program expands the potential of CAVO to benefit many more patients across different solid tumor malignancies and in multiple ICI combinations. We strongly believe that many more eligible patients could benefit from Cabo Mesa. Cabo Medics remains the number one prescribed single-agent 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 Cabo Xanthinib in combination with immune checkpoint inhibitors expands and progresses. The exciting data from 9ER is the first of many phase three combination trials to read out.

We expect to date or which second half of 2020 and are thrilled to have the complete ninee our dataset presented at ESMO.

Most importantly, we are focused on building on checkmate 90, our success as we advance additional indications for Cabo and investigate a diverse portfolio of next generation Exelixis cancer medicines.

I'll close by thanking everyone like selections for their efforts over the quarter under obviously challenging conditions. The majority of our team has been working from home for almost five months no and continues to excel across all components of our business with great teamwork skill and energy.

The entire Exelixis team is working as one in making every day count as we discovered 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.

PJ: 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 CaboMedx to all eligible patients as we continue to build the Cabo franchise and maximize its clinical and commercial potential. With that, I turn the call back over to Mike.

In the call for questions.

As a reminder, classical question you want me to press Star one on your telephone to withdraw your question first about <unk>. Please standby what we compile the two when a roster.

Our first question comes on the line of you're wrong Werber from Cowen. Your line is now open.

Michael M. Morrissey: All right. Thanks, PJ. As I said in today's introduction, we had a strong second quarter and are working to build on the momentum from the first half of 2020 across a range of commercial, clinical, and discovery opportunities. But at the same time, as we acknowledged on the Q1 call, we recognize the risk to our business should the pandemic continue to grow in severity, as we've sadly seen over the last several months. We will continue to push forward in these challenging times with employee and patient health and safety always our highest priority. We expect a data-rich second half of 2020 and are thrilled to have the complete 9ER data set presented at ESMO. Most importantly, we are focused on building on Checkmate 9ER's success as we advance additional indications for CABO and investigate a diverse portfolio of next-generation Exelixis cancer medicines.

Hi, Hi, this is the deal on full year all are there congrats on the great quarter and thanks for taking my questions I just have one questions regarding the.

First line RCC compared to nine mix.

Can you comment on you mentioned that 75% off and making sure scrap by the I O combos pay you a specified be the split between Io Io and I O <unk> I'm, just wondering because I guess, what would you guys are trying to Oh sure. It failed in all this category.

In Oh, you put line RCC, maybe you can take a common I'll be it the fed wearable goods category. How you guys are what you think too.

Thank you.

Yeah, Hi, Leo this is PJ. Thank you for the question few comments there is as you did mentioned, yes, it's a first line.

I see I combination market shares approximately 75%, it's roughly half split between I see I T can and I see I for iOS.

Michael M. Morrissey: I'll close by thanking everyone at Exelixis for their efforts over the quarter under obviously challenging conditions. The majority of our team has been working from home for almost five months now and continues to excel across all components of our business with great teamwork, skill, and energy. The entire Exelixis team is working as one to make every day count as we discover, develop, and commercialize the next generation of our medicines for cancer patients in need of better and more effective therapy. 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.

That said I think you know as I mentioned, we're really pleased with and confident in the 90, our data and.

As as we've talked about the study design previously, it's really a broadly applicable dataset.

Cross clinical risk categories, both are all favorable intermediate and poor risk.

And really you know what we see is utilization both of those I O combinations in all of those and we're going to clearly positioned this data broadly and ticket really can have impact.

For all first line RCC patients and we're really excited to be able to two Ah yes.

Operator: As a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound key. Please stand by while we compile the Q&A roster. Our first question comes from the line of Yaron Werber from Countwin. Your line is now open.

Upon approval I'm sure that data in great detail with our customers oncologists.

Hi, Thanks.

Thank you. Our next question comes from the line of as they can go no warden from Truest Security. Your line is now open.

Leo An: Hi, hi, this is Leo An on behalf of Yaron Werber. Congratulations on a great quarter and thanks for taking our questions.

Hi, guys. Thank you for taking my questions, Chris I'd like to stuff do you see I'm just checking what was the gross to net for Cabo into second quarter. Just wondering if there's a little less bounced back from what we customarily no. He's a weaker once you.

PJ: I just have one question regarding the first line RCC competitive dynamics. Can you comment on, you mentioned that 75% of the market share is grabbed by the I.O. combos. Can you specify the split between I.O., and I.O.? and I.O. TKI? I'm just wondering because I guess you guys are trying to share data in all risk categories in first line RCC. Maybe you can comment on the favorable risk category, and how the 9-R was differentiated in that segment. Thank you.

Yes so.

Okay.

Thanks, because as Chris so its in the 22% range for the for the quarter, Oh slightly higher and the first quarter because of the Medicare part D.

PJ: Yeah, hi Leo, this is PJ. Thank you for the question. A few comments there, as you did mention, yes, the first line ICI combined market share is approximately 75%, and it's roughly half split between ICI TKI and ICI, or IOIO. That said, I think, you know, as I mentioned, we're really pleased with and confident in the 9ER data, and as we've talked about the study design previously, it's really a broadly applicable data set across clinical risk categories, both are all favorable, intermediate, and poor risk. And really, you know, what we see is utilization of both of those IO combinations in all of those, and we're going to clearly position this data broadly and think it really can have an impact on all first-line RCC patients, and we're really excited to be able to, you know, upon approval, share that data in great detail with our customers and with oncologists.

No as I said during the fourth quarter call in February we worth or expectation for a gross to net for the year is between 23, 24%.

As we as we look to the.

The future.

Got it. Thank you on and then you know we have.

Tens of banking, it's easy for first line I'm wondering in general what do you guys looking for and that launch to I guess evaluate if it's PC market is evolving like ours. He did.

And then I got one final question after that.

Hi, Yes pick up this is a PJ. Thanks for the question you know with regards to T.H.C.C. I think what we've talked about is primarily with the.

The data and now the subsequent approval in may of potential above we anticipate nursery frankly, beginning to see.

That combination move quickly into the first line setting in HCC. So what we think will happen is I see I combination therapy will become the standard care in the first line setting and that will do a few things settle potentially expanded the patient pool of patients in the first line who are able to two.

PJ: Sorry, but thanks.

Asthika Sarith Goonewardene: Thank you. Our next question comes from the line of Asthika Goonewardene from Truist Security. Your line is now open.

Receive a systemic therapy relative to other local regional therapies in HCC.

Chris: Hi, guys. Thank you for taking my questions. Chris, I'd like to start with you, please.

So we would look forward with some appropriate results from the cosmic three went to study to really being able to compete.

Chris: Just checking, what was the gross net for Carbo in the second quarter? We're just wondering if there's a little less bounce back from what we customarily know is a weaker 1Q. And then I've got a couple more.

In that large and growing market also we see then the second line setting in HCC is Io, which has about 50% share over the last few quarters in in second line data moved to the first line and create more opportunity for Teekay monotherapy in the second one which we think.

Chris: Okay, thanks. I think it is Chris. So, it's in the 22% range for the quarter, slightly higher in the first quarter because of Medicare Part D. You know, as I said during the fourth-quarter call in February, we were

Cabometyx is really well position to compete for with regards to our broad data and overall survival in that setting. So that's kind of how we view HCC evolving over the next couple of years.

Chris: Our expectation for gross net profit for the year is between 23 and 24 percent, as we look to the future here.

Great. Thank you and then just want to tick up a minute guys, which one I'm walking us through some of the AD Board feedback you've got at ASCO four.

PJ: Got it, thank you. And then, you know, we have Tezo Bev on HCC's first line. I'm wondering, in general, what are you guys looking for in that launch to, I guess, evaluate if the HCC market is evolving like RCC did? And then I got one final question after that.

Cohort seven.

You said, you're talking about the one cohort from deal to one data that was presented at ASCO AOL feedback that yeah. Sure do you feel you want to pick that one.

Sure absolutely and thank you for the question and and saw the non cohort just to remind everybody was.

PJ: Yeah, hi Asthika. This is PJ.

PJ: Thanks for the question. You know, with regard to HCC, I think what we've talked about is primarily, you know, with the data and now the subsequent approval in May of a TESOBEV, we anticipate and are frankly beginning to see that combination move quickly into the first line setting in HCC. So what we think will happen is ICI combination therapy will become the standard of care in the first line setting. And I'll do a few things that will potentially expand the patient pool of patients in the first line who are able to receive systemic therapy relative to other local regional therapies in HCC. So, you know, we would look forward to appropriate results from the COSMIC-312 study to really being able to compete in that large and growing market.

Checkpoint inhibitor and chemotherapy pretreated non small cell lung cancer patients.

And it did she was a cohort at from the cost nickel to one steady we are evaluating the combination of public onto a cheez it can come up and.

Importantly, and it's quite pre treated patient population so with the combination therapy, a 27% objective response rate and Lisa confirmed objective responses.

That were quite durable.

In this setting I think the feedback but certainly.

Sorry, encouraging data and.

Various key wells said please.

She feedback.

We're very intriguing interested on Timor.

This cohort in its you know.

PJ: Also, we see the second line setting in HCC as IO, which has about 50% share in the second line. In the next few quarters, that'll move to the first line and create more opportunity for TKI monotherapy in the second line, which we think Cobblemedics is really well positioned to compete for with regard to our broad data and overall survival in that setting. So that's kind of how we view HCC evolving over the next couple.

We have assumed expanded the cohort if I another 50 patients.

Close to Cook teaching ball, Mike nomadic launch in cohort, but also evaluating humiliating public option to address the question of contribution components Andy.

Framework off the Cosmical to one study so I look forward to providing more information.

Good thanks for taking my questions guys.

PJ: Great, thank you. And then just want to take a minute, guys; would you mind walking us through some of the Ad Board feedback you got at ASCO for Cohort 7?

Uh huh.

Thank you Sir our next question comes from a line of Peter Lawson from Barclays. Your line is now open.

Gisela: Are you talking about the Lung Cohort from CO2-1 data that was presented at ASCO, KOI?

Hi, Thanks for taking my questions just on worked Oh, no I know it data at ESMO, there any specific aspects that data that you're pointing us through to help kind of highlight that differentiation and other particularly risk groups that you go after initially.

Gisela: Yeah, sure. Diesel, do you want to take that one?

Gisela: Pick that one. Sure, absolutely. Thank you for the question. And so the Lung Cohort, just to remind everybody with Checkpoint Inhibitor and Chemotherapy Pre-Treated Non-Small Cell Lung Cancer Patients. And this was a cohort from the Cosmic Ultraman study, where we are evaluating the combination of copazontinib and atelizumab. Importantly, in this quite pre-treated patient population, we saw, with the combination of ARP, a 27% objective response rate, and these were confirmed objective responses that were quite durable in this setting. I think the feedback was certainly that this was encouraging data, and the various KOLs that we received feedback from were very intrigued and interested in seeing more from this cohort. And as you know, we have since expanded the cohort by another 50 patients and are close to completing enrollment in that expansion cohort. We are also evaluating single-agent carbazantinib to address the question of contribution of components in the framework of the COSMIC-021 study, so I look forward to providing more information.

Hey, Peter It's Mike Yeah. Thanks for the question look all the data is important and I would.

I think we believe that it'll be a very fulsome presentation, and you'll get a very good sense across literally every data point for how it steps up.

As a novel combination in the first line setting and you'll obviously went into your [laughter]. Your normal comparisons that you guys normally do so but it's you know I would look at all the data. It's it's important to take at the look you know take the totality of that data in the context of its ability to have an impact in that population. So we're going.

I'm excited about it and then certainly the data we had any it came back in April I think is a good good segue for what you can expect so stay tuned.

Okay, there, particularly a sub groups you go after initially what you feel there could be.

Easier to penetrate.

Yeah, I think based that he just said previously it's based on the data we're going to target all patients in the first line setting that we think that date is that strong and we think it's a very competitive offerings.

Gisela: Great. Thanks for taking my questions, guys. Thank you.

Great. Thank you and then just picking up on some of that Pete mentioned the decline in Teekay market. Overall in Q2, I think he's mentioned you think it's a temporary issues like 'cause it related or is that structural and then is that any 'cause it impact in two key to true expectations.

Peter Lawson: Thank you, Asthika.

Michael M. Morrissey: Thank you. Our next question comes from the line of Peter Lawson from Barclays. Your line is now open.

Michael M. Morrissey: Hi, thanks for taking my questions. Just on the HARVO 90-hour data at ESMON, are there any specific aspects of that data that you would point us to to help kind of highlight that differentiation? And are there particular risk groups that you go after initially?

Michael M. Morrissey: Hey Peter, it's Mike. Yeah, thanks for the question. Look, all the data is important, and I would think we should believe that it'll be a very fulsome presentation. And you'll get a very good sense across literally every data point for how it stacks up as a novel combination in the first line setting. And you'll obviously want to do your normal comparisons that you guys normally do. So, but it's, you know, I would look at all the data; it's, it's important to take at the whole picture, you know, take the totality of that data in the context of its ability to have an impact on that population. So we're very excited about it. And certainly, the data we had in the EK back in April is a good, good segue for what you can expect. So stay tuned.

For Threeq.

Yeah, Hi, Peter is PJ. So a couple those things that I won't come first of all I won't.

I won't foreshadow Q3, since we're talking about Q2 here today.

I would say is with regards to Q2 and the historical prescription a total prescription trx data you know theres always some variation there.

It was down 2% for the market basket quarter over quarter, but what we really see as Q1 was relatively high so even though it was down it really sort of returned or what were the standard levels in the last couple of quarters. The prior year. So I'd say generally it's its stable and don't.

Really anticipate any.

In the absence of Crystal ball, obviously, any long term structure will impact due to the coated because these are very sick patients with them metastatic disease.

Michael M. Morrissey: Are there particular subgroups that you go after initially where you feel that it could be easier to penetrate?

Okay, and then Cabo in Twoq, what was the impact do you think from some code.

Michael M. Morrissey: Yeah, I think based on, as PJ said previously, it's based on the data; we're going to target all patients in the first line setting. And we think the data is that strong. And we think it's a very competitive offering.

Oh, yes. So you know what we saw Trx. It was it was.

Same as the market down slightly 2%, there and we did see I'm sort of in the initial shelter in place.

PJ: Great. Thank you.

PJ: And then just picking up on something that PJ mentioned, the decline in the TK market overall in Q2, I think he mentioned that. Do you think it's a temporary issue? Is it COVID-related, or is that structural? And then is there any COVID impact in 2Q you can talk through, and expectations for 3Q?

Just a small decline in new prescriptions I think as folks were not going to their health care providers, which is really something we've heard across earnings discussions in the industry and we saw that recover.

Into June so really you know some some small impacts.

But you know as I mentioned generally perceived the business to be stable and all the metrics kind of point to that.

That's okay. Thank you so much.

PJ: Yeah. Hi Peter. This is PJ. So, a couple of those things.

Thank you.

Thank you. Our next question comes on the line of Jason Gerberry from Bank of America. Your line is dolphin.

PJ: First of all, I won't foreshadow Q3 since we're talking about Q2 here today. What I would say is with regard to Q2 and the historical prescription, total prescription TRX data, you know, there's always some variation there. It was down 2% for the market basket quarter over quarter, but what we really see is that Q1 was relatively high. So even though it was down, it really sort of returned to what were the standard levels in the last couple quarters and the prior year. So I'd say, generally, it's stable and don't really anticipate any changes. In the absence of a crystal ball, obviously, any long-term structure... These are very sick patients with metastatic disease.

Hey, guys. Thanks for taking my questions.

Just two for me.

First I was curious do you guys heard roche's comment on Twoq, you call about frontline HCC being about a three to 400 million dollar market opportunity in the United States and struck me as a little bit low, but perhaps they're a lot of factors that can go into a number like that like proportion of patients moving over to systemic therapy versus taste.

Oh, I am Brave 150 trial inclusion criteria the narrowness of that so just curious if you had any thoughts regarding that number if you fundamentally think it can be a much bigger market opportunity than that and then my second question.

PJ: And then for Carbo in 2Q, what was the impact, do you think, from COVID?

In terms of the Cabo patent dispute I'm curious whenever and larger generic companies.

PJ: Oh, yes. So, you know, what we saw in TRX was the same as the market, down slightly 2% there. And we did see sort of in the initial shelter in place, just a decline in new prescriptions, I think, as folks were not going to their healthcare providers, which is really something, you know, we've heard across earnings discussions in the industry. And we saw that recover into June. So really, you know, some small impacts. But, you know, as I mentioned, I generally perceived the business to be stable, and all the metrics kind of point to that.

Got off patent protection around alternative Cabo salt forms and so those companies have not been able to file generic applications for whatever reason.

I'm curious if you guys have any views regarding those salt farms that they ultimately inherently lack the necessary stability.

Not the grade like Cabo and one form or end to form I should say and are bioavailability characteristics I'd be really helpful. I understand thanks.

Jason Matthew Gerberry: Okay, thank you so much.

Michael M. Morrissey: Thank you. Thank you. Our next question comes from the line of Jason Gerberry from Bank of America. Your line is now open.

Yeah, Jason Thanks, It's my God will have PJ a answer the first question and I'll provide some commentary on the second.

Yeah. Thanks, Jason for the question, so I'll comment on the HCC opportunity I.

Michael M. Morrissey: Oh, hey, guys. Thanks for taking my questions. Just two for me. First, I was curious about

I wouldn't want to you know a pine on roche's guidance in one way or another with regard to that opportunity, but I, what I would say is in the U.S. right, it's a pretty large market.

Michael M. Morrissey: I'm curious if you guys heard Roche's comments on 2Q Call about Frontline HCC being about a $300 to $400 million market opportunity in the United States. It struck me as a little bit low, but perhaps there are a lot of factors that can go into a number like that, like the proportion of patients moving over to systemic therapy versus TACE, the I Am Brave 150 trial inclusion criteria, and the narrowness of that. So, just curious if you had any thoughts regarding that number, if you fundamentally think it could be a much bigger market opportunity than that. And then my second question, in terms of the Cabo patent dispute, I'm curious whether a number of larger generic companies have sought patent protection around alternative Cabo SALT forms, and so those companies have not been able to file generic applications for whatever reason. And I'm curious if you guys have any views regarding those salt forms, you know, if they ultimately inherently lack the necessary stability to not degrade like Cabo and its N1 form or N2 form, I should say, and or bioavailability characteristics.

You know the ballpark.

20 to 23000 patients looking a couple of years forward in the United States Thatll have metastatic disease, there and as I mentioned, we do see that.

Amount of patience is better therapies moved into that setting we see that increasing gradually over time.

You know with regards to obviously revenue opportunities a lot of things.

Go into that the number of patients the duration of therapy, the price et cetera, but as we view it will certainly have a compelling a compelling story.

Presuming a positive data in the three one to study is potentially the first Io teekay <unk> in that marketplace. So we're certainly.

I would be excited about that and think we'd have the opportunity to help a large amount of patients and have significant growth for for the Cabo franchise there.

Okay. Good thank you.

In terms of your question about other sold forms relative to Anda filers, certainly stable to the obvious theres. Many factors that go into play in slipping a sole form for.

Large scale utilization scale up and then you know clinical and commercial efforts so.

Michael M. Morrissey: That'd be really helpful to understand. Thanks.

There's a lot caster the window that picking the right. So form I, certainly don't want to Oh pine and other.

Michael M. Morrissey: Yeah, Jason, thanks. It's Mike. We'll have PJ answer the first question, and I'll provide some commentary on the second.

Other salt forms I'm out there right now for all the obvious reasons as well, but needless to say would you know we chose to Mount wait for a reason we chose the polymorph that we did for a reason and we've been now obviously very successful at both US you know scaling that up and then commercializing that that form. So so full steam ahead there.

PJ: Thanks, Jason, for the question. So I'll comment on the HCC opportunity. But I wouldn't want to, you know, comment on Roche's guidance, in one way or another, with regard to that opportunity.

PJ: But I would say in the US, right, it's a pretty large market. You know, the ballpark of 22 23,000 patients looking a couple years forward in the United States that'll have metastatic disease there. And, as I mentioned, we do see that the number of patients as better therapies move into that setting, we see that increasing gradually over time. You know, with regard to obviously revenue opportunities, a lot of things go into that: the number of patients, the duration of therapy, the price, etc. But as we view it, you know, we'll certainly have a compelling, compelling story. Presuming positive data in the 3.1.2 study, it is potentially the first IOTKI in that marketplace. So we're certainly would be excited about that and think we'd have the opportunity to help a large number of patients and have significant growth for the Cabo franchise there.

Okay, great. Thanks, guys.

Thank you.

Thank you. Our next question comes on the line of Michael Schmidt from Guggenheim. Your line is now open.

Hey, guys. Thanks for taking my questions I had a a few me maybe starting out with one for Gisela.

About the costs make three one to study I think you talked about enrollment and sell the mechanics around reaching their required number of PFS and Oh actually events.

I I think in the past Youve talked about and.

Potentially interim analysis based on response rate I'm, just wondering if that's still.

PJ: Okay, good. Thank you.

Michael M. Morrissey: In terms of your question about other SALT forms relative to antifilers, certainly, in a statement of the obvious, there are many factors that go into play in selecting a SALT form for large-scale utilization, scale-up, and then clinical and commercial efforts. So there's a lot riding on the wind of that in picking the right SALT form. I certainly don't want to comment on other SALT forms out there right now for all the obvious reasons, but needless to say, we chose the malate for a reason, we chose the polymorph that we did for a reason, and we've been obviously very successful at both scaling that up and then commercializing that form. So full steam ahead there.

Planned and if you could provide any additional information on on that front.

Great. Thank you Michael So of course mix, we want to has always been designed the co primary endpoints PFS and Oh it.

And there are no interim analyses plan for PFS or for that matter to your question objective response rate.

However for overall survival data interim analyses plan Jumbo statistical analysis plan.

HM.

Tracking those events of course, and now that the studies fully unfolds.

And looking at both people and Oh, I see one trucking pieces and towards final analysis for that the former PFS.

Michael M. Morrissey: All right, great. Thank you, guys.

Michael Schmidt: I think that's it. Thank you.

Gisela: Thank you. Our next question comes from the line of Michael Schmidt from Guggenheim. Your line is now open.

Gisela: Hey guys, thanks for taking my questions. I had a few.

For the first interim analysis for oil.

Gisela: Maybe I'd start out with one for Gisela about the COSMIC 312 study. I think you talked about enrollment and some of the mechanics around reaching the required number of PFS and OS events. I think in the past you've talked about a potential interim analysis based on response rate. I was wondering if that's still planned and if you could provide any additional information on that front.

And now this.

Ongoing.

Oh, Okay, great understood and then.

DTC cost me three you want to one so that's another near term I'm, saying that's coming up.

Could you just help us maybe understand some of the assumptions that you've made and kind of you know bracketing boat market potential and in that particular indication.

Gisela: Great. Thank you, Michael.

Gisela: So, Cosmic 3.1.2 has always been designed with the co-primary endpoints of PFS and OS, and there are no interim analyses planned for PFS or, for that matter, to your question, objective response rate. However, for overall survival, there are interim analyses planned in the statistical analysis plan. So, we're tracking those events, of course, and now that the study is fully enrolled, and looking at both PFS and OS events, tracking these events towards final analysis for the former PFS and for the first interim analysis for the latter OS. And that is ongoing.

Yes.

I'm sorry so.

D. So do I had why did you start and then P.J. can pick up from there.

Yeah, I'm happy to discard Chester within the basic trial design asleep.

Randomized placebo controlled study and change more differentiated tire cancer that we have received radio hi, Don therapy, and feel bad and also have Ritchie private your car targeting therapy.

So I'd rather be treated patient population studies design wins and co primary endpoints objective response rate and add progression free survival.

Gisela: Okay, great, understood. And then on DTC, COSMIC 311, so that's another near-term thing that's coming up. Could you maybe help us maybe understand some of the assumptions that you've made in kind of, you know, bracketing the market potential in that particular industry?

And as we've said the objective response rate now a teach won't be based upon the first 100 patients involved.

Gisela: Yeah.

Gisela: Go ahead; why don't you start and then PJ can pick up from there? Yeah, I'm happy to start with just the basic trial design. It's a randomized, placebo-controlled study in patients with differentiated thyroid cancer who have received radioiodine therapy and failed that, and then also have received private FR targeting therapy. So it's a rather pre-treated patient population. The study's designed with co-primary endpoints of objective response rate and progression-free survival. And as we've said, the objective response rate analyses will be based on the first 100 patients involved, and that was achieved earlier in the year, in February, and so we're looking to conduct the analysis for this co-primary endpoint of objective response rate in the second half. And the second endpoint is progression-free survival amongst all randomized patients. So that's the basic trial design, and I'll hand over to PJ.

And that it's been achieved really ending February and so.

The underpinning to conduct the analysis for the co primary endpoints objective response rate in the second call.

And the second and point is progression free survival amongst all randomized patients.

So that's the basic trial design and open pit feature.

Yeah, Hi, Michael I'll, just what I'd add to that is.

There's quite a number of of differentiated thyroid cancer patients I think about over 50000 per year in the U.S. This trial, obviously looks at.

Metastatic ARIA refractory patients Huskies will said who had previously received.

PJ: Yeah, hi, Michael. I'd just add to that. You know, there's quite a number of differentiated thyroid cancer patients, I think about over 50,000 per year in the US. This trial obviously looks at, you know, metastatic RAI refractory patients, as Gisela said, who had previously received systemic therapy or a TKI. So you know, taking into account that part of the population. What I'd say importantly, though, is there's really no randomized data or approved agent for that setting. So certainly an opportunity to help patients in that area who have progressed on prior therapy and also an opportunity to really sort of utilize and draw on the historical experience Exelixis has in thyroid cancer as a company to help those patients. And it tends to be a malignancy that patients are on therapy for a little bit longer. I would've framed it that way.

The systemic therapy or T.K. I so.

Taking into we take into account that part of the the population what I, what I'd say importantly, though there's there's really no.

Randomized data are approved agent for that setting so I'm certainly an opportunity to.

To help patients in that area, who progressed on prior therapy and also an opportunity.

To really sort of utilizing draw on the historical experience exelixis hasn't thyroid cancer as a company to help those patients and it tends to be a malignancy that patients are on therapy for a little bit longer as well, so I would frame it that way.

Okay, Great and then on Oh nine to I guess, what's your expectations be here with respect to this upcoming data presentation and.

PJ: Okay, great. And then on XL092, I guess what expectations should be here with respect to this upcoming data presentation? And can we talk about the choice of the expansion cohorts, the selection of the tumor types to be included in those, is that based on clinical data coming out of the Phase I study or maybe more related to just a mechanistic hypothesis behind the mechanism of Exelon-I too?

Maybe talk about the choice of the expansion cohorts to the selection of the tumor types to being killed. It in Dallas is that based on clinical data coming out of the phase one study or maybe more.

More related to just say a mechanistic a hypothesis behind the a the mechanism self exline too.

Peter: Yeah, why don't we answer that question with Peter first and then Gisela after?

Yeah, why don't we answer that question with Peter first and then use why I'm sure.

Peter: Yeah, this is Peter. Yeah, with respect to upcoming publication, as I said, we have submitted an abstract to a major medical meeting. So we're looking forward to, you know, providing updates of substantial data on XL092 later in the year.

Yeah. This is this is Peter yeah with respect to upcoming publication. We said we have submitted an abstract two major medical meeting.

So we're looking forward to providing update and substantial Daytona so im going to later in the yeah.

I don't really want to foreshadow, what exactly that's going to be way, we haven't finalized the presentation at this point, but as as we get abstract acceptances, we'll be happy to provide.

Peter: We want to foreshadow what exactly that's going to look like.

Peter: Provide details of when and where the presentation will take place.

Gisela: Okay. Okay. Oh, sorry.

Details when and where the presentation will happen.

Yeah Okay.

Gisela: No, I'm sorry. Go ahead, Lisla.

Oh, sorry.

Oh I'm sorry go ahead Lisa.

Gisela: Okay, and just a couple words on the clinical development approach. Of course, we are making progress in the dose escalation phase, single agent evaluation, and looking forward to combination approaches with checkpoint inhibitors in the first instance for XL092. And as we're looking, of course, at development opportunities, we've learned a lot and have certainly a large body of experience based upon cabozontinib and XL092 being a next generation Vegefarm, MET, and family kinase inhibitor. We intend to apply these learnings, beginning, of course, with the expansion cohorts and the various different indications, but also looking at the data So certainly, I am looking forward to providing more updates here and looking forward to moving XL092 forward rapidly and to next stage development.

Okay, and just a couple of words on the clinical development approach course, they're making progress in the dose escalation phase single agent devaluation looking forward to combination approaches with checkpoint inhibitors and because instead for EXL on that too.

Yes, and then looking of course it development opportunities.

Learned a lot and have certainly.

Logic and body of experience based upon public antonym, and so not all that to being.

A generation.

And that you find match and can tell me kind it's inhibitor.

We intend to apply these learnings and beginning of course with the expansion cohorts and the various different indications, but also.

Looking at their data emerging from this broad comp assumption of calls and.

Such as well to one study with its 20 cohorts and but also ice tea and.

She took program what keeps you made a lot of interesting information. So certainly looking forward to providing a more update here and looking forward to moving on to forward rapidly into late stage development.

Peter: Okay, thanks. And then, one last time, if I may, I think I heard PJ make some comments around business development, mentioning interest in new technology platforms. And I was just wondering if you could maybe help clarify if you're actually thinking about acquiring a new platform technology or if we should think about this more along the lines of partnership or R&D collaboration or something along those lines?

Okay. Thanks, and then one last if I may I I think I heard PJ make some comments are on business development mentioning.

Interest and new technology platforms, and I was just wondering if you could maybe help clarify if you actually thinking about acquiring a new cloud from technology or if we should think about this more along the lines, so slow partnership or R&D collaboration or something along those lines.

Peter: Yeah, Michael, that was Peter with his very distinguished accent, so I'll let him further comment upon that question. Peter, go ahead.

Yes, Michael that was that was Peter with his with his very distinguished accent. So I'll, let him a further a opine upon that question Peter but yes, it's Peter yes. It was him. It was in my section. So I mean look we've we've always been looking for.

Peter: Yeah, this is Peter. Yeah, it was in my section.

Peter: So, I mean, look, we've always been looking for technologies that will complement what we do internally. I think we do what we do internally very well. We've got the big compound library back. We're running high-throughput screening again. We've got, you know, a deep background in medicinal chemistry, so we're able to interrogate a reasonably broad range of targets. But, you know, there are technologies and approaches out there that really broaden the target landscape and, you know, provide differentiated therapeutic modalities. I think that's why, from a partnership... Partnering BD point of view, we're looking very extensively at both, you know, biologics of various kinds, the iconic tissue factor targeting ADC, which hopefully will be our first biologics IND later in the year. So we're continuing to look broadly, and that can be either individual assets, or it can be technologies that, you know, might be best done in collaboration or partnership rather than being brought in-house. So, obviously, the way in which those things will transpire is very much on a case-by-case basis.

Technologies that will complement what we do internally I think we do what we do internally do very well for the big compound Library, we're running high throughput screening again, we've got.

The background in medicinal chemistry, so we're able to interrogate reasonably broad range of targets, but.

Fluid technologies and approaches to help the that we broadened the target landscape and.

Provide differentiated therapeutic modalities I think that's way from a partnership.

Partnering BD point of view.

We're looking very extensively at both.

Biologics at various times.

The iconic tissue factor targeting a D.C. hopefully we'll be office biologics I envy later and later in the here.

So we're continuing to look broadly and that can be the individual assets or it can be technologies that you know might be best dawning collaboration and partnership a rather than being brought brought in house.

So obviously, we will go the way in which those things will transpire is pretty much a case by case basis.

Peter: Okay, great. Thanks for clarifying.

Okay, great. Thanks for clarifying.

Thank you. Our next question comes on the line of Andy Psi from William Blair. Your line is now open.

Andy Tsai: Thank you. Our next question comes from the line of Andy Tsai from William Blair. Your line is now open.

Michael M. Morrissey: Oh, great. Thanks.

Okay, great. Thanks, Thanks for taking my questions and I hope everybody is doing well and staying healthy at Exelixis I'm interested in your interpretation in terms of Pembro went bad news activity in checkpoint experienced patients in RCC I think they showed over 50% response rate at the ask so.

Gisela: Thanks for taking my questions and hope everybody's doing well and staying healthy at Exelixis. I'm interested in your interpretation in terms of Pembro-Limbatinib's activity in checkpoint experience patients in RCC. I think they showed over a 50% response rate at ASCO. Maybe help us put that in context, especially, I think you and Rose just started the phase three contact, the restudy in a very similar patient

Maybe help us put that in context, especially I think you and roche's started the phase three contact three study in a very similar.

As you population.

Yeah, and its Mike Thanks for that thanks for the question I'll try and give you. Some some perspective you know any any single arm not a randomized combination study is all that's always a bit to the challenging to interpret in isolation.

Michael M. Morrissey: Yeah, Andy, it's Mike. Thanks for the question. I'll try and give you some perspective. You know, any single-arm, non-randomized combination study is always a bit challenging to interpret in isolation. There's lots of, even with CABO, single agent data from numerous ISTs that have CABO showing a response rate by itself in the 40 to 50 percent range based upon different second line populations post-IO. So it's challenging, certainly interesting data. There's lots of interesting data across the board out there right now in the second line setting. I think the commitment that we and Roche have made relative to CONTACT-3 looking at a randomized study of CABO at TESO versus CABO in that setting is the right experiment to do.

Theres lots of the even with Cabo a single agent data from numerous iced teas that has you know cabo showing a response rate by itself in the 40% to 50% range based upon a different different a second line populations post IPO. So it's it's a challenging I'm certainly interesting data there's lots of interesting data.

Across the board out there right now in the second line setting I think the a b b the commitment that we and Roche have made relative to contact threea looking at a randomized study of cobble at Tesoro versus combo in that setting is is there right experiment to do you have out you have a randomized.

Michael M. Morrissey: You have a randomized control arm with a single agent that allows you to understand the contribution of components and get a very clear picture of what the combination does, what retreatment with an IO does on top of a really good TKI versus the TKI by itself. So we think that's the right study to do. We're excited to be working with Roche on that, and obviously, that's up and running now, and hopefully, we'll enroll some folks.

No control arm with a single agent that allows you to understand the contribution of components and get a very clear picture on what the combination does what retreat with an IPO does on top of I really good teekay I personally that teekay by itself. So so we think that's the way study to do are said to be working with Roche on that and obviously, that's up and running now end to hopefully.

We will enroll fast.

And just to follow up I think it you know one of the unique factors that study is the non clear cell histology, either you or your enrolling so if you look a lot of guidelines.

Michael M. Morrissey: to follow up, I think, you know, one of the unique factors of that study is the non clear cell histology that you're, you're enrolling. So, you know, if you look at a lot of guidelines, you know, I guess, nitinib is probably the only recommended option. So just kind of help us think about by enrolling that patient, you know, the strategy going forward to potentially expand into the non

Hey, guys submitting it is probably the only recommended option. So just kind of help us think about by enrolling Dab pay shed a you know that the strategy going forward to potentially expand into the non clear cell histology.

Gisela: Yeah, that's a great question. I'm gonna punt that one over to Gisela to opine upon Gisela.

Yeah, that's great question I'm going on I'm going to put that went over to Gisela to opine. Upon these wells.

Absolutely. Thank you put the question so yeah, the ink, including both a T cell and non clear cell patients and this quantico three study.

Gisela: Absolutely. Thank you for the question.

Gisela: So, yeah, including both clear cell and non-clear cell patients in this CONTACT-03 study. We've, of course, collected data and information and are looking forward to the presentations at ESMO about the combination of AQAVO and ATIASO. And this patient population was a dedicated cohort of non-clear cell carcinoma patients in this study. So that information certainly also influenced the willingness to include a little bit broader patient population in this randomized study. So, I am certainly looking forward to data from the trial.

Yes of course.

Connected to gauge on inflammation and looking forward to the presentations and.

The combination of a probably a teenager.

In this patient population was a dedicated cohort one key until carcinoma patients and steady.

So that inflammation certainly also entering the.

Willingness to include a little bit product patient population.

This randomized studies, so certainly looking forward to data from the trial.

Gisela: Oh, great. Thanks for that insight.

Okay, great. Thanks for that a insight and maybe one for Peter.

Andy Tsai: And maybe one for Peter. So the company is advancing two TKIs, right? 0, 9, 2, and 265.

So the companies it is advancing to Teekay guys, right 092 and 265.

Peter: So beyond just the differences in target profile, one being, you know, probably more MET focus and TAM focus, help us understand the strategic positioning in terms of advancing two TKIs in parallel.

So beyond just the differences in target profile, one being probably more met focusing Tam focus just help us understand this strategic positioning in terms of advancing to teekay in parallel.

Peter: Yeah, so this really goes back, Andy, to our, you know, obviously our wealth of experience with calisthenics, both clinically and preclinical, and the, you know, I think expanding and very encouraging data sets for that compound, both as a single agent and increasingly in combination with IO.

Yeah. So this will be goes back a and b to.

Well from experience with cameras, Anthony both clinically and pre clinically and the.

You know I think expanding and very encouraging data sets for that compound both as a single agent and increasingly in combination with I O. So.

Peter: Yeah, we felt it made a lot of sense to go back to that well and investigate next-generation variants of Cabo, and, you know, we had a number of thoughts and ideas about how we might, how we might tweak or change the profile. 092 is the first of those; it is a met VEGFR, as we've discussed. More data on that compound will be published later in the year. Excel 265 is much more MET-PAN-K focused, so significantly less VEGFR.

Yeah, we felt it made a lot of things to go back to that well and investigate [laughter] acceleration variants of Cabo and don't forget we had a number of thoughts and ideas about how we Mike how we might tweak it would change the profile.

I'm going to was supposed to those it it is meant to fall off as we've discussed.

More data wrong on that compound.

We will be published later in the year, except to six five is much more met 10-K focus and less significantly this venture if off.

So.

We'll see how the preclinical data for that.

Peter: So we'll see how the preclinical data for that emerge, and that will drive to a large extent where those things go clinically. But it's been such a, I would say, productive and interesting area that we want to make sure we have the ground covered there. So there may be more variants to come. We're still working in the area, so we'll see.

Okay, and that will drive and large extent.

You know where those things go clinically.

But it's such a you know it's it's been so cheap I would say productive and interesting areas.

We want to make sure we have the ground covered there. So there may be more variance to come.

But we're still working in the area. So we'll see.

Andy Tsai: Great. Nice. Yeah, that's interesting. Thanks. Thanks for sharing that perspective. Cool. Thanks for answering all my questions and congratulations on all the progress. I look forward to the 9ER presentation. Absolutely.

Great. Thanks.

That's interesting thanks, thanks for sharing that that perspective.

Oh, Thanks for answering all my questions and congratulations on the progress look forward to the 90 our presentation absolutely.

Peter: Great, Andy, thank you.

Great any thank you.

Ken Shield: Thank you. Our next question comes from the line of Ken and McKay from RBC Capital Markets. Your line is now open.

Thank you. Our next question comes from the line of Kennen Mackay from RBC capital markets. Your line is now fan.

Gisela: Hey, thanks for taking the question. Quick one on bladder cancer. This is a treatment landscape that has dramatically changed and is continuing to change. Just wanted to get your perspective on potentially looking at a CABA cohort, combining CABA with PADCEV or PADCEV plus a checkpoint in some way, shape, or form, whether it's part of COSMIC or otherwise. Uh, yeah, Gisela?

Hey, Thanks for taking my question on a quick one on platter cancer. This is a treatment, let's get the has dramatically changed and is continuing to change just wanted to just your perspective on potentially looking other cabo cohorts.

Combining cabo pads or how to plus a checkpoint in some way shape or form whether it's part of a cosmetic or or otherwise.

I guess [laughter] go ahead please.

Gisela: Go ahead, please.

Sure.

Gisela: Sure. Well, as you stated, bladder cancer is certainly an evolving landscape with new opportunities and new compounds being introduced, and treatment strategies really shifting. And we're certainly monitoring that field very, very closely. We've seen single-agent activity with CARBO. We've seen good activity with checkpoint inhibitors. And one such experience has been presented at the recent ASCO-GU conference in previously treated patients with bladder cancer. And so we continue to evaluate the opportunities here and are certainly thinking about combinations with different compounds that play important roles in the field. And that could be with CARBO, but it could, importantly, also be with Exel-192. So that is certainly on the list of things to evaluate and potentially drive forward and develop.

Well, if you stay that and bladder cancer, certainly ended having landscape with a new opportunity 10, new components and being introduced and treatment strategies really shifting over time.

And with fitting monitoring that feel it very very closely we've seen it single agent activity. That's cobble we've seen good.

Activity with checkpoint inhibitors and one such.

Experience has been presented to add everything else could you you conference and.

Previously treated patients with not a cancer and so that we continue to evaluate the opportunity here and are certainly thinking about.

Combination of with different compounds that play important roles in this field and.

And that could be with cobbled it but it could importantly, all to be with except Warner She would show that is.

Certainly on the list of things too.

Evaluate and potentially drive forward and development.

Gisela: That's it. Thanks so much.

Got it thanks much.

Stephen Douglas Willey: Thank you. Our next question comes from the line of Stephen Wiley from Stiefel. Your line is now open.

Thank you. Our next question comes from the line of Stephen a widely from Stifel. Your line is now fan.

PJ: Yeah, good afternoon. Thanks for taking the questions. Just in terms of the comments regarding being launch-ready, I guess, to commercialize 9ER by the end of August, is that in anticipation of maybe getting some kind of NCCN compendia listing prior to formal approval?

Yeah. Good afternoon, thanks for taking the questions.

Just in terms of the comments regarding being launch ready I guess two to to commercialize maniar by the end of August is is that in anticipation of maybe getting some kind of NCCN compendia listing prior to a formal approval.

PJ: Yeah. Hi, Stephen. This is PJ. You know, I think we've been doing a heck of a lot of work since we saw the results of 9ER to get ready for the launch. I wouldn't comment or speculate on what Compendia or NCCN would do with that. But obviously, it's really important for us to be ready to go and educate physicians and

Yeah, Hi, Stephen This is a PJ you know I think.

We're we've been doing a heck of a lot of work since we've we've seen the results of 90 or to get ready for the launch.

Yeah, I wouldn't comment or speculate on what.

India or NCCN do with that.

But obviously, it's really important for us to be ready to go to.

Just to be ready to educate physicians and you know people aren't ready to bring that benefit of cabometyx to patients.

PJ: And you know, be launch ready to bring that benefit of Cabo Medix to patients as soon as possible, pending approval, because we really do view that as an important opportunity to drive incremental market share broadly in the first line setting, as well as potentially for longer. So we just want to be ready to go.

As soon as possible pending approval.

Because we really do you view that isn't important opportunity to drive incremental market share broadly in the first line setting as well as potentially duration beyond that so we just want to be ready to go.

Okay, and I guess when you know we saw the most recent update of the keynote four to six data there was.

Michael M. Morrissey: And I guess when, you know, we saw the most recent update of the Keynote 426 data, there was some deterioration in the event-driven hazard ratios. And so, I guess, you know, Given that, how do you think the presentation of the initial data plays out with prescribers, given I guess the historical context around 426 and does that almost make subsequent presentations of NINI that much more important or potentially that much more meaningful?

Some deterioration in the event driven hazard ratios and so I guess.

Given that how do you think the.

Presentation of the initial data.

Plays out with prescribers, given I guess, the historical context around four to six and does that almost made.

Subsequent presentations of 90 are that much more important or potentially that much more meaningful.

Michael M. Morrissey: Much more meaningful,

Michael M. Morrissey: Yes, Steve, it's Mike. Look, you know, all data is important all the time. Certainly, that's been magnified in the renal area with follow-up looks at data for a variety of different trials, combinations, et cetera, over the last few years. You know, I wouldn't want to speculate on how the 9ER data might evolve over time, but certainly, you know, there's, I think, very solid data. I think, as I mentioned earlier in the Q&A, the totality of that data needs to be looked at very carefully in the context of the potential benefits that CABO can bring in combination with NEVO across a broad patient population. So, but, you know, look, it's data is data, and we continue to get data. We'll continue to look at new data and evolve the story as the data evolves.

Yes, Steve It's Mike what you know all data is important in all the time certainly that's been magnified in the in the renal area with.

A follow up looks at data for a variety of different trials combinations et cetera over the last the last few years, you know would want to speculate on how the 90, our data might or might evolve over time, but certainly you know theres very solid they're very solid data.

I think as I've mentioned the in earlier in the queue and they the totality of that data needs to be looked at very carefully in the context the potential benefit.

Cabo can bring in combination with me, though a across the broad patient population, so but yeah. It's datas data and we continue to get data. We will continue to look at new data.

And evolve the story as it did it evolves.

Michael M. Morrissey: All right, and then maybe just lastly to follow up on the BD side. You know, I think...

All right and then maybe just lastly to follow up on the on the BD side.

Michael M. Morrissey: You guys have kind of characterized your approach previously as kind of being, you know, a bit agnostic and maybe a little bit value focused. And, you know, you now have a stable of preclinical aspects, a number of them that are going to be ready to enter the clinic here over the next, I guess, nine months or so. And I guess from a portfolio management perspective, you kind of feel like you need to go out and maybe purposefully shop a little bit more within kind of that mid-tier development space, just to kind of fill the gap between some of the earlier preclinicals and the commercial drugs that you have, or do you kind of feel that that will all kind of take care of itself?

I think you guys have kind of characterize your approach previously is kind of being a bit agnostic and give you a little bit value focused and you know you now have a stable of preclinical assets a number of them that are going to be ready to enter the clinic here over the next I guess nine months or so and I guess historically.

Kaleo management perspective, you kind of feel like you need to go out and maybe purposely shop, a little bit more within kind of that mid tier development space just to kind of fill the gap between some of the earlier preclinical Olson.

And the commercial out Oh, the commercial drugs that you have or do you kind of feel that that will all kinda take care of itself.

Michael M. Morrissey: So we're certainly very interested in doing a lot of work looking at, I would say, clinical stage assets right now. That's been a focus of ours for a while.

So we're certainly very interested in the and doing a lot of work looking at them I would say clinical stage assets right now that's been a focus of ours for awhile and.

Michael M. Morrissey: And, you know, the question always comes down to data, existing data, the potential to generate clinically differentiating data that can drive, you know, sized commercial opportunities, as we've seen with Cabo in the past. So, we have a very clear lens for how we want to look at clinical data, look at opportunities that are both within indications that we're currently pursuing and outside of those indications. So there's certainly a large portfolio of both clinical and preclinical assets that we're currently, investigating to, I think, say appropriately. And I think, as Peter said very eloquently, once we complete those transactions, we'll be talking more about why we did what we did in the themes and the kind of the way we're looking at kind of bending these approaches together in terms of our internal platform, the molecules that we've So stay tuned. Obviously, I don't want to say a lot of specifics right now except to say that we've got a big, big effort here, and I'm hoping that it will come to fruition in the short term.

The question always comes down to data existing data the potential to generate clinically differentiating data that can drive you know no upsized commercial opportunities as we see with combo in the past. So so we have a very clear wins for how we want to look at clinical data look at opportunities that are both.

Within indications that we're currently pursuing and outside of those indications so.

There's certainly a large portfolio of both clinical and preclinical assets that were currently.

Investigating said I think I'd say appropriately and I think as Peter said very eloquently. Once we once we complete those transactions, we'll be talking more about why we've done what we've done in the themes and be kind of the way. We're looking at kind of building. These approaches together in terms of our our internal.

Form the molecules that we've got indications that we've got and maybe most importantly, the via vertical integration that we worked so hard to build over the last few years. So.

Stay tuned obviously don't want to see a lot of sits right now except to say that we've got a big.

Big effort here and I'm, hoping that it will come to fruition I'm in the short term.

Michael M. Morrissey: Great. Thanks for taking the questions. Yes.

Great. Thanks for taking the questions Yep, Okay. Thanks, Steve.

George Farmer: Yep. Okay. Thanks to you.

Peter: Thank you. Our next question comes from the line of George Farmer from BMO Capital Markets. Your line is now open.

Thank you Sir our next question comes on the line of George Farmer from BMO Capital markets. Your line is now open.

Peter: Hi, thanks for taking my question.

Hi, Thanks for taking my question could you comment a little bit on.

George Farmer: Um, could you comment a little bit on, um, your factor ADC? Iconic.

Our eyes, you factor AIDC.

Hi, Onyx that's a.

Peter: We'll be going into the clinic shortly. Seattle Genetics just reported some positive data with its ADC tissue factor targeting agent. Are you thinking about cervical cancer, ovarian cancer, or do you go into an Alzheimer's population prior to picking your indication?

Going into the clinic shortly I shall genetics, that's reported some positive data with its a DC tissue factor targeting agent you thinking about cervical cancer ovarian cancer or.

Do you know in an all time or population.

Prior to picking your indication.

Peter: Yeah, thanks, George. Peter, want to take that one?

Yeah, Thanks, George Peter will pick that one.

Peter: Yeah, so, I mean, you're correct, right? This is, you know, there is clinical proof of concept for tissue factor targeting ADCs. The iconic version of this was compelling to us because of some differentiation that it provided.

Yeah. So I mean, you correct right. This is there was clinical proof of concept for tissue factor targeting a b C.

The iconic.

Hey version of this was compelling to us.

Because of differentiation that it provided it'd be premature for me to speculate on what to discuss what a clinical strategy might be but at this point.

Peter: It would be premature for me to speculate or to discuss what our clinical strategy might be at this point. But again, later in the year, we anticipate presenting data, preclinical data, obviously, on this agent at a meeting, and when we have that information, we'll certainly let you know. And yes, we're currently on track to file the IND this year. So hopefully that will come to fruition.

But again later in the yeah, we anticipate.

Presenting data.

Preclinical data obviously on this agent at a meeting and when we have that information.

Well certainly we'll certainly let you know and yes. We are currently on track still finally I Andy this year, so hopefully hopefully that will come to fruition.

Peter: Okay, great. And moving on to CABO, do your revenue assumptions, your guidance this year, include on-use following non-ER results? And if so, can you kind of walk us through some of your assumptions?

Okay, great and.

Moving onto cable.

Youre do yours.

Revenue assumptions your guidance. This year does that include on use following 90, our results and if so can you kind of walk us through some of your assumptions.

Peter: Yeah, George, this is Chris. So, you know, the current revenue guidance of 725 to 775 does not include 9ER, an assumption of 9ER in our net product revenue for the year. Okay, very good. All right. Thanks very much. Okay, thank you.

Yeah. George this is Chris So he has a current revenue guidance a 725 to 775 does not include nine Youre an assumption of many are in the in our net product revenue for the year.

Okay very good alright, thanks very much.

Peter: Okay, thank you, George.

Thank you.

Thank you. Our next question comes from the lineup Paul Choi from Goldman Sachs. Your line is now open.

Paul Choi: Thank you. Our next question comes from the line of Paul Choi from Goldman Sachs. Your line is now open.

Gisela: Thank you. Good afternoon, everyone, and thanks for taking our questions. Two quick ones for me.

Thank you good afternoon, everyone and thanks for taking our questions two quick ones for me first on the contact or one trial.

Gisela: First, in the CONTACT-01 trial, the inclusion-exclusion criteria didn't differentiate between non-SQUAMOUS and SQUAMOUS patients. So can you maybe help us understand the decision to include SQUAMOUS? And then does the statistical analysis assume an analysis of the entire population, or are you going to treat that separately between the SQUAMOUS and non-SQUAMOUS populations? And then second, on the XL092 plus checkpoint inhibitor combinations that Peter mentioned in slides, can you maybe just elaborate on, you know, what sort of patients you'll initially be targeting there? Will it be a basket, or are you primarily describing testing it in healthy volunteers?

Inclusion exclusion criteria doesn't differentiate between non squamous and non squamous patients. So can you maybe help us understand the decision to include squamous and then.

The statistical analysis assume.

An analysis of the entire I'll population or you're going to treat that separately between the squamous and non squamous populations and then second on the.

Our axle online two plus a checkpoint inhibitor combinations that Peter mentioned in slides on can you maybe just to elaborate on what sort of patients you will initially be targeting there will not be a basket or are you primarily describing testing it in healthy volunteers. Thank you.

Thank you Paul do you feel you want to how those questions was.

Gisela: Thank you. Thank you, Paul.

Yeah. Thank you. Thank you and so I am first question regarding once more.

Gisela: Thank you, Paul. Gisela, would you like to handle those questions, please?

CIC funding, but in a pre treated non small cell lung cancer of course names.

Gisela: Yeah, happy to. Thank you.

Gisela: So, your first question regarding concept 01 and sex-finding inhibitors in pre-treated non-small cell lung cancer. Of course, there's an unmet medical need for both squamous and non-squamous cell histologies, and so we decided to go forward with both because there's data, of course, for atelizumab by itself in both histologies. We also, ourselves, have inflammation focal presumption by itself in both histologies, dating back to the RDT study, and have seen activity in both histologies. So, we didn't see a reason to exclude these patients.

Medical need and poop off a screen this insurance claim is.

Histologies and something I decided to go for work involved the consists.

<unk> data of course, and poor and he's an easing up like health and both and it's still in teeth. We also are telling to have a incidents you took up attention it by itself and both histologies and dating back to the RV chief steady.

And have seen activity in both.

Okay. So we didnt hear reason to exclude these patients.

Gisela: So, we came to the conclusion to include both histologies. The assumptions around both are integrated, of course, in the protocol, but outcomes were similar in various checkpoint inhibitor trials. So regarding the analyses, of course, these histologies are going to be integrated into the trial as one thinks about subset analyses and stratification and so on. So that's the plan as it goes forward with the study. Your second question: I'm sorry, I forgot about that. I haven't taken a note of it. Go ahead.

There.

So we came to conclusion can persist RG <unk> assumptions around barrels.

Integrating and of course in the protocol.

Simonette and varied a checkpoint inhibitor trials.

So regarding the analyses and of course and these technologies are going to be integrated and.

The trial and when think about sepsis analyses and stratification. So one.

So that that's the plan and as.

As it is going forward thinking with the study and.

Second question I'm, sorry, I forgot now [laughter] kick in and out of overhead Oh sure. It's just in our with regard to the testing of the Zillow nine two plus checkpoint inhibitor combinations, where you're referencing testing in healthy volunteers or if not what sort of patients are you considering it initially for.

Gisela: Oh, sure. It's just in our, with regard to the testing of the XL092 plus checkpoint inhibitor combinations, were you referencing testing in healthy volunteers, or if not, what sort of patients are you considering initially for the combination? Thank you.

For the combination thank you.

Gisela: Sure, so we are not looking to test the combination in healthy volunteers. The plan is really to evaluate the appropriate dose in patients with advanced malignancies and then expand into expansion cohorts that are more histology-specific. And so this will be including patients with RCC or CRPC and other cancer types, certainly building on the experience that we have gathered and our co-presentation has developed.

Sure So and we're not looking to test the combination in healthy volunteers.

The time, it's really too.

Value like at the appropriate Gill and patients with advanced malignancies, and then expand into expansion cohorts that are more histology specific.

And so at this will be including patients right.

CRP Yeah are there other sensitize so.

Certainly building on the experience if we have gathered and a couple of them to development program.

Thank you.

Gisela: Terrible. Thank you.

Sure Paul Thank you.

Paul Choi: Thank you. As a reminder, to ask a question, you will need to press star 1 on your telephone. To withdraw your question, press the pound key. Our next question comes from the line of Jeff Hung from Morgan Stanley. Your line is now open.

Thank you as a reminder, chaska question you want me to press Star one on your telephone to withdraw your question press the pound <unk>. Our next question comes from a line of Jeff Hong from Morgan Stanley. Your line is now open.

Jeff Hung: Hey, thanks for taking my questions. Two quick ones, actually. Just to clarify on the stable new patient starts, can you provide more color on where those are relative to earlier in the year? Have they returned to pre-COVID levels? And then I have a follow-up. Thanks.

Hi, Thanks for taking my questions two quick ones actually I'd just to clarify on stable new patient starts on can you provide more color on where those are relative to earlier in the year have you returned to pre coping level and then I've a follow up thanks.

PJ: Oh yeah. Thanks, Jeff, for the questions. PJ Yeah, what we'd say is, you know, with regard to that, we did see, and I think, similar to the market basket, as well as other disease areas, a bit of a drop off in new patient starts that started in May, and then recovered to sort of a standard level that we've been seeing for sort of quarters on the whole in June. So we've seen that kind of stabilize, and as I mentioned, I thought it was really driven by more, you know, patient access to the health care system generally being really stressed during that sort of six to eight week period, late March into early April.

Oh, yes, thanks, Jeff for the questions PJ, Yeah, what what we'd say is.

With regard to that we did see and I think similar to the market basket as well as other disease areas.

A bit of a drop off in new patient starts that needed in may and then recovered to sort of a standard level that we've been seeing for sort of quarters on the whole in June. So we've seen that kind of stabilize and as I mentioned thought it was really driven by more.

You know patient access to health care system, generally being really stressed during that sort of 60 week period.

In late March into early May.

Gisela: Okay, thanks. And then I believe previously the 312 data were expected by year, and then now it's first half of 21. Is this change more from enrollment impact from COVID, or is it too early to think that events are taking longer than expected? Thank you.

Okay. Thanks, and then I believe we previously 312 data were expected by year end and now its first half 21 is this change more from enrollment impact from co bid or is it too early to think that events are taking longer than expected. Thank you.

Gisela: Yeah, Gisela, go ahead, please.

Yeah I just want to go ahead. Please.

Gisela: Sure. Well, thank you for the question.

Sure.

Well. Thank you for the question and as Weve stated earlier on in nickel and B study has now completed global and involvement and they were very pleased with the progress that coal big impact.

Gisela: And as we've stated earlier in the call, the study has now completed global enrollment, and we're very pleased with the progress. The COVID impact was really very modest and was more early in the year, in March and April, where we saw some impact on patient screening and enrollment, but that has quickly reversed, so enabling us to complete enrollment in the global study. And with that, now, we're tracking events very closely, as I said earlier, for both PFS, for the final analysis, and overall survival for the first interim analysis. Both are very important endpoints, of course, and as we're tracking these events, we're seeing them come in a little bit slower than anticipated, and we're expecting now, per the current projections, that we would achieve these events towards the end of 2020 or early 21, And so, that is really a very similar situation as we have just a little while ago stepped through with the CheckMate 9ER analyses that followed a similar path. We are certainly looking forward to providing more granularity as we accumulate more events and have more precise estimates.

We need very modest.

It's more.

Early in the year in March and April every so some important patient screening and enrollment.

Quickly we purchased.

Enabling us to complete enrollment in the Gulf of steady.

And with that now we are tracking events very closely as I said earlier Fulfils PFS for the final analysis and overall survival.

For the first interim analysis book are very important endpoints of course, and as you're tracking these events switching them come and there's a bit slower than anticipated.

I am expecting now for the current protection.

Good.

She's devens towards the end of Twentytwenty.

Or early 10-Q, one and a bad but needless to say topline data in the first half.

21.

And so that it's really a very similar situation as you may have just another buyback stepped through the checkmate 90, our analyses <unk> followed a similar pod with me looking forward to providing more granularity as of the accumulate more event.

And have a more precise estimate.

Jeff Hung: Thanks for clarifying that.

Thanks for clarifying.

Susan T. Hubbard: Thank you. At this time, there are no further questions. And so, I will turn the call over to today's host, Susan Hubbard. Thank you, Gigi, and thank you all for joining us.

Thank you at this time there are no further questions and so I will turn the call over to today its health Susan Hubbard Ms Hubbard.

Thank you Jackie and thank you all for joining US today, we welcome your follow up calls with any additional questions. He may have that we are unable to test during today's call.

Susan T. Hubbard: Thank you, Gigi, and thank you all for joining us today. We welcome your follow-up calls with any additional questions you may have that we were unable to address during today's call.

Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.

Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.

Operator: BF-WATCH TV 2021

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