Q3 2019 Earnings Call

A reminder, disclose be recorded for replay purposes.

Operator: 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.

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

Susan T. Hubbard: Thank you, Gigi, and thank you all for joining us for the Exelixis 3rd Quarter 2019 Financial Results Conference Call. Joining me on today's call are Mike Morrissey, our President and CEO, Chris Senner, our Chief Financial Officer, PJ Haley, our Senior Vice President of Commercial, and Gisela Schwab, our Chief Medical Officer, who will together review our corporate, financial, commercial, and development progress for the Peter Lamb, our Chief Scientific Officer, is also with us and will be joining us for the Q&A session following our prepared remarks. During the call today, we will refer to financial measures not calculated according to generally accepted accounting principles. Please refer to today's press release, which is posted on our website, for an explanation about reasons for using such non-GAAP measures, as well as tables deriving these measures from our GAAP results.

Thank you Judy and thank you all for joining us for the Exelixis third quarter 2019 financial results Conference call.

Joining me on today's call or Mike Mccarthy, our President and CEO , Chris Center, our Chief Financial Officer, PJ, Haley or senior Vice President of commercial Gisela Schwab, our Chief Medical Officer, well together of your corporate financial commercial and development progress for the third quarter ended September Thirtyth 2019, Peter.

Really young our Chief Scientific Officer is also with us Sim only be joining us for the acuity session. Following their prepared remarks.

During the call today, we will refer to financial measures not calculated according to generally accepted accounting principles. Please refer to today's press release, which is posted on our website for an explanation about reasons for using such non-GAAP measures as well as tables, writing these measures from our GAAP results.

Susan T. Hubbard: During the course of this presentation, we will be making forward-looking statements regarding future events and the future performance of the company. This includes statements about possible developments regarding discovery, product development, regulatory, commercial, financial, and strategic matters. Actual events or results could, of course, differ materially. We refer you to the documents we file from time to time with the SEC, which under the heading Risk Factors, identify important factors that could cause actual results to differ materially from those expressed by the company verbally and in writing today, including, without limitation, risks and uncertainties related to product commercial success, market competition, regulatory review and approval processes, conducting clinical trials, compliance with applicable regulatory requirements, our dependence on collaboration partners, and the level of cost associated with discovery, product development, business development, and commercialization.

During the course of this presentation, we will be making forward looking statements regarding future events in the future performance at the company.

Include statements about possible development guarding discovery product development regulatory commercial financial and strategic matters actual events or results could of course differ materially. We refer you to the documents we file from time to time with the FCC, which under the heading risk factor identify important factors that could cause.

Actual results could differ materially noted expressed by the company verbally and in writing today, including without limitation risks and uncertainties related to product commercials exam market competition regulatory review and approval process east conducting clinical trials compliant applicable regulatory requirements our dependence on clever.

Ration partners and the level of cost associated with discovery product development business development and commercialization activities.

Susan T. Hubbard: All right. Thank you, Susan.

With that I will turn the call over to Mike Alright. Thank you Susan and thanks to everyone for joining us on the call today actually ones, who had a strong third quarter 29 team with important progress across all components of our business.

Michael M. Morrissey: And thanks to everyone for joining us on the call today. Exelixis had a strong third quarter 2019 with important progress across all components of our business. We maintain significant momentum as we strengthen the Cabo Medics franchise, expedite our Cabo Zanzibar development program, and diversify our oncology pipeline with new agents from internal and external. I'll begin today by providing a brief summary of our third quarter 2019 milestones, and then turn the call over to Chris, PJ, and Gisela to review important components of our business. Key highlights for today's call include first, Exelixis continues to deliver strong financial performance in the third quarter of 2019. Total revenue for the quarter was approximately $272 million. Net Component and Franchise revenue was approximately $192 million. Third quarter non-GAAP net income was approximately $108 million, and non-GAAP diluted earnings were $0.34 per share.

We maintained significant momentum as we strengthen the Cabometyx franchise Expediter, a comprehensive development program and diversify our oncology pipeline with new engines from internal and external sources.

I'll begin today by providing a brief summary of our third quarter 2019 milestones and then turn the call over to Chris P.J. and Gisela to reveal important components of our business.

Key highlights for today's call include first.

So what's his continued to deliver strong financial performance in the third quarter 2019 total revenue for the quarter was approximately $272 million nets accomplished into their franchise revenue was approximately $192 million third quarter non-GAAP net income was approximately 100.

$8 million non-GAAP diluted earnings were 34 cents per share.

Michael M. Morrissey: Importantly, for the first time, Global Cabo Zante franchise net revenue exceeded $1 billion over four consecutive quarters. The renal cell carcinoma TKI market has been growing steadily over the last several quarters as immune checkpoint inhibitors or ICI combinations have begun to dominate the first line setting, which bodes well for Cabo's Antidote if the Checkmate 90R study generates competitive data. Cabo's antenna net product revenue was essentially flat quarter over quarter due to a delay in the transition of ICI TKI progressing patients from first to second. This results from the approximately four-to-five-month extension of progression-free survival for the first-line ICI combos compared to first-line incident. As you'll hear later, Cabo Medix continues to be the TKI of choice for patients progressing on any first-line ICI combination. Second, we continue to aggressively pursue development and regulatory efforts to expand the CABOS Antenna.

Importantly for the first time global cobbles into print <unk> net revenue exceeded $1 billion over four consecutive quarters.

The Reno renal cell carcinoma, Teekay <unk> market has been growing steadily over the last several quarters as immune checkpoint inhibitors are where I see I combinations have begun to dominate the first one setting which bodes well for accomplishing into it if the checkmate nine New York City generates competitive data.

Cabos antenna net product revenue was essentially flat quarter over quarter due to a delay in the transition I see I T. I progressing patients from first to second line.

This results from the approximate four to five month extension a progression free survival for the first line I see a combo is compared for the compared to first line today.

Sure here later Cabometyx continues to be the Teekay <unk> of choice for patients progressing on any first line I see I combination regimen.

Second we continue to aggressively pursue development and regulatory efforts to expand the cabos antenna franchise.

Michael M. Morrissey: We are quickly advancing four ongoing pivotal trials, including the critical CHECKMATE-90R trial in first-line RCC with the CABO Inigo doublet, and anticipate starting additional CABO Xanthinib pivotal trials from emerging COSMIC-021 data, including potential studies for prostate cancer and non-small cell lung cancer. We expect to start sharing key data from some of these trials in 2020. In addition, we are encouraged by the recent success of the atizolizumab and nevacizumab doublet to improve both overall survival and progression-free survival in first-line HCC, a third indication where an ICI-antiangiogenic combination has generated compelling efficacy data. This result provides additional support for COSMIC-312, investigating the COBO-ATESA combination in first line HCC, and also highlights a potential expanded role for COBO-MEDEX in second line HCC once this ICI-containing regimen moves into the first line.

We are quickly advancing for ongoing pivotal trials, including the critical Checkmate 90, our trial in first line RCC with the copper nickel doublet and anticipate starting additional cobalts Antonin pivotal trials from emerging cosmic go to one data, including potential studies for prostate cancer in non small cell lung cancer we.

Back to start sharing key data from some of these trials in 2020.

In addition, we are encouraged by the recent success of the it because it was a man. This is a mess double it to improve both overall survival and progression free survival in first line HCC.

Third indication when I see I anti Angie agenda combination has generated compelling efficacy data.

This result provides additional support for cosmic 312 investigating the Kabul. It tells a combination in first line HCC and also highlights a potential expanded role for Cabometyx in second line HCC. Once this I see I containing regimen moves into the first line setting.

Michael M. Morrissey: While all these Cabo Santa-related activities are proceeding with the highest priority, our team is advancing XL092 and other internally and externally sourced assets to build a diversified oncology product. Third, last month, we received the Paragraph 4 certification notice from a Cabo Medics and a filer, and we responded by filing a lawsuit yesterday to enforce our intellectual property rights. Based on the limited information we have received to date, Anda Filer has not challenged our composition of matter patent, which expires on August 16, 2020. Through our lawsuits, we are seeking, among other relief, an order that FDA may not approve this ANDA until after the expiration of our polymorph patent on October 8, 2030. Our progress throughout Q3 2019 highlights the company's performance across all components of our business during a very dynamic time for both RCC and HCC indications. Our overall strategic goals remain the same. We seek to grow revenues, manage expenses carefully, and reinvest free cash to build a diversified business capable of long-term sustainable growth. So with that, I'll turn the call over to Chris, who will provide more details on our third quarter 2019 financial results.

While all of these cobalts antenna related activities are proceeding with the highest priority. Our team is advancing xotwo nine two and other internally and externally sourced assets to build a diversified oncology product pipeline.

Third last month, we received the paragraph four certification notice from a kind of Cabometyx Anda filer and we have responded by filing a lawsuit yesterday to enforce our intellectual property rights.

Based on the limited information we have received to date the and the father has not challenged our composition of matter patent, which expires in August 16th 2026.

Through our law suit, we are seeking among other relief and order that ft. It may not approved anda until after the expiration of our polymorph patent on October 820 30.

Our progress throughout Q3 2019 highlights the company's performance across all components of our business during a very dynamic time for both RCC and H.C. seeing indications our overall strategic goals remain the same we seek to grow revenues managed expenses carefully and reinvest free cash to build a diversified.

Business capable of long term sustainable growth.

So with that I'll turn the call over to Chris will provide more details on our third quarter 2019 financial results.

Christopher J. Senner: Thanks, Mike. For the third quarter, the company reported total revenues of $271.7 million. Total revenues for the quarter included compositive net product revenues of $191.8 million. Total revenues also include the recognition of $79.9 million in collaboration revenues from the company's commercial collaboration partners Ipsen, Takeda, and Genentech. Collaboration revenues for the third quarter included the recognition of a $50 million milestone from our collaboration with Ipsen for the achievement of $250 million of net sales of Cabo Zantanib in their territories over four consecutive fiscal quarters. We anticipate receiving the cash payment related to this milestone in the fourth quarter of 2019.

Thanks, Mike for the third quarter. The company reported total revenues of $271.7 million total revenues for the quarter included cobbles negative net product revenues of $191.8 million.

Total revenues also includes the recognition of $79.9 million in collaboration revenues from the company's commercial collaboration partners Gibson Takeda and genetic.

Corporation revenues for the third quarter included the recognition of a $50 million milestone from our collaboration with hips and for the achievement of $250 million of net sales of cobalts entered into and their toward towards over four consecutive fiscal quarters.

We anticipate receiving the cash payment related to this milestone in the fourth quarter 2019 collaboration revenues also includes $16.4 million of royalties earned approximately $73 million of cut was additive sales by absent in the third quarter 2019.

Christopher J. Senner: Collaboration revenues also include $16.4 million of royalties earned from approximately $73 million of Cabo Zantanib sales by Ipsen in the third quarter of 2019. Our total operating expenses for the third quarter of 2019 were $156.1 million, compared to $148.3 million in the second quarter of 2019. R&D expense was the primary driver of the increase in total operating expenses, which increased by $15.4 million and were significantly impacted by the license agreement we signed with Origin during the third quarter. Under the terms of the agreement, Exelixis made an upfront payment of $10 million for exclusive options to license three pre-existing programs from Orgene. In addition, Exelixis and Orgene selected three additional Orgene-led drug discovery programs on mutually agreed-upon targets in exchange for additional option payments totaling $7.5 million.

Our total operating expenses for the third quarter 2019 were $156.1 billion compared to $148.3 million in the second quarter 2019, R&D expense was the primary driver of the increase in total operating expenses, which increased by $15.4 million and were significantly impacted by the license agreement, we signed with Aurigene during the third.

Third quarter.

Under the terms agreement excludes this made an upfront payment of $10 million for exclusive options to license three preexisting programs emerging in addition, exelixis and arching selected three additional orgy lead drug discovery program, a mutually agreed upon targets in exchange for additional option payments totaling $7.5 million.

Patrick J. Haley: Income taxes for the quarter ended September 30, 2019 were $25.2 million, and our effective tax rate for the quarter was approximately 20.5%, compared to $20.7 million and 20.8% for the second quarter of 2019. The company reported net income of $97.5 million, or $0.31 per share on a fully diluted basis, for the third quarter of 2019. The company also reported non-GAAP net income of $107.6 million, or $0.34 per share on a fully diluted basis. Non-GAAP net income excludes the impact of approximately $10 million of stock-based compensation expense net of the related income tax effect. Cash and Cash Equivalents, Short and Long-Term Investments, and Long-Term Restricted Cash and Investments totaled approximately $1.25 billion at September 30, 2019, compared to approximately $852 million at December 31, 2019.

Income taxes for the quarter ended September Thirtyth, 2019 were $25.2 billion and our effective tax rate for the quarter was approximately 20.5%.

Compared to $20.7 million and 20.8% for the second quarter 2019.

The company reported GAAP net income of $97.5 million worth 31 cents per share on a fully diluted basis for the third quarter 2019.

The company also reported non-GAAP net income of $107.6 million were 34 cents per share on a fully diluted basis non-GAAP net income excludes the impact of approximately $10 million the stock based compensation expense net other related income tax effect.

Cash cash equivalents short and long term investments and long term restricted cash and investments totaled approximately $1.25 billion at September Thirtyth 2019.

Impaired approximately $852 million at December 31, 2018.

Now turning to our financial guidance. The company is updating its financial guidance for 2019.

Cost of goods sold is expected to be between 4%, 5% of net product revenues research and development expense is expected to be.

Approximately $350 million and includes non cash expenses related to stock based compensation of approximately $20 million.

Patrick J. Haley: Now turning to our financial guidance. The company is updating its financial guidance for 2019. Cost of goods sold is expected to be between 4% and 5% of net product revenue. Research and development expenses are expected to be approximately $350 million, and this includes non-cash expenses relating to stock-based compensation of approximately $20 million. Selling General Administrative Expenses is expected to be approximately $240 million and includes non-cash expenses related to stock-based compensation of approximately $40 million. Guidance for the effective tax rate in 2019 is between 21% and 23%. With that, I'll turn the call over to PJ. Thank you.

Selling general administrative expenses are expected to be approximately $240 million and includes non cash expenses related to stock based compensation of approximately $40 million.

Guidance for the effective tax rate in 2019 is between 21% and 23%.

With that I'll turn the call over to PJ. Thanks.

Thank you Chris I'm pleased to review the commercial performance of Cabometyx for the third quarter 2019.

Cabometyx continues to be the number one prescribed teekay in RCC, which is notable in the context of three recent first line launches of immune checkpoint inhibitor or ICI combinations.

Cabometyx demand grew by 14% in Q3 2019 relative to the third quarter in 2018 and declined by 4% in Q3 2019 relative to Q2 2019.

The prescriber base of Cabometyx continue to increase and grew by 40% in Q3 2019 relative to Q3 2018 and grew by 7% in Q3 2019 relative to the prior quarter.

Patrick J. Haley: Thank you, Chris. I'm pleased to review the commercial performance of Cabo Medix for the third quarter of 2019. Cabo Medix continues to be the number one prescribed TKI in RCC, which is notable in the context of three recent first-line launches of Immune Checkpoint Inhibitor, or ICI, combinations. Cabo Medix demand grew by 14% in Q3 2019, relative to the third quarter in 2018, and declined by 4% in Q3 2019, relative to Q2 2019. The prescriber base of Cobomedics continued to increase and grew by 40% in Q3 2019 relative to Q3 2018 and grew by 7% in Q3 2019 relative to the prior quarter.

Cabometyx continues to be used broadly in RCC across the academic and community settings clinical risk groups and lines of therapy.

The first line RCC market remains very dynamic is IC tcs combinations of both Pembrolizumab accident.

And development fix it and then were launched in Q2, joining Ipilimumab Nivolumab as first line IC combination options.

The Q via brand impact data shows that I see I combinations now dominate the first line RCC market as expected, resulting in the TTM monotherapy, new patient class share decline driven by the new data and approvals.

Cabometyx market share in the first line declined as expected after the Pemex CE launch and then stabilized in late Q3, 2019, and performed well relative to other RCC Teekay I monotherapy.

Couple of Medix continues to be the number one prescribed teekay in RCC based on the acute via prescription data.

Patrick J. Haley: Cabo Medics continues to be used broadly in RCC across academic and community settings, clinical risk groups, and lines of therapy. The first line, the RCC market remains very dynamic, is ICI TKI combinations of both pembrolizumab, exitinib, and Avellumab. Exitinib was launched in Q2, joining ipilimumab and nivolumab as first-line ICI The QVIA brand impact data shows that ICI combinations now dominate the first line RCC market as expected, resulting in the TKI monotherapies new patient class share declining, driven by the new data and approval. Cabo Medics market share in the first line declined as expected after the Pemaxi launch and then stabilized in late Q3 2019 and performed well relative to other RCC TKI monotherapies. Tabomedics continues to be the number one prescribed Year over year for Q3, TaboMedx was up 18% in TRX volume, and Q3 over Q2 TRX volume declined by 1%.

Year over year for Q3, Cabometyx was up 18% in Trx volume.

In Q3 over Q2, Trx volume declined by 1%.

And importantly, the overall teekay market grew by 8% in total volume year over year.

Furthermore, this market grew 5% sequentially for each of the last two quarters demonstrating that the RCC teekay market is expanding driven by the adoption of ITI teekay combinations, particularly in the community setting.

It is worth noting that cabometyx maintained overall market share in this growing and competitive teekay market.

Moving onto the dynamics of second line RCC.

Hello, Medix, new patient market share increased in the third quarter 2019.

Also cabometyx continues to capture the majority of patients who progress on first line Nivo MP therapy, According to brand impact.

Cabometyx continues to be well positioned as a treatment of choice for patients who progress on I see I combination therapy, whether it is nivo it be or primero pembro accede.

An increasing number of patients in the second line setting had been previously treated in first line with an ITI combination and we expect this first line to second line transition to continue as the market dynamics have yet to reach steady state.

Patrick J. Haley: And importantly, the overall TKI market grew by 8% in total volume year over year. Furthermore, this market grew 5% sequentially for each of the last two quarters, demonstrating that the RCC TKI market is expanding, driven by the adoption of ICI TKI combinations, particularly in the community setting. It is worth noting that Cabo Medics maintained overall market share in this growing and competitive TKI market. Moving on to the dynamics of second-line RCC, Cabo Medic's new patient market share increased in the third quarter of 2019. Also, Cabo Medics continues to capture the majority of patients who progress on first-line Nevo Hippie therapy according to brand impact. Cabo Medics continues to be well positioned as the treatment of choice for patients who progress on ICI combination therapy, whether it is Nebo-Ipi or Pembroax.

As this transition happens the utilization of second line T.K. I monotherapy should continue to increase while the market for second line IC decreases as an increasing percentage of patients entering the second line or IC progressors.

Market research continues to point to Cabometyx remaining each one of choice in the second line setting after any ICI combination, which we believe is largely due to the fact that it's the only teekay with a strong Pos benefit per the label in the second line population.

Turning to the HCC market dynamics.

Last week Roche Genentech announced a positive study for the combination of Bevacizumab in at Tesla is a map in first line HCC demonstrating superiority to search revenue in both progression free survival and overall survival.

This result is notable in the context of the recent negative checkmate four or five nine study evaluating single agent involve them up against a wrap and in this seems that.

Patrick J. Haley: An increasing number of patients in the second line setting have been previously treated in first line with an ICI combination, and we expect this first line to second line transition to continue as the market dynamics have yet to reach steady state. As this transition happens, the utilization of second-line TKI monotherapies should continue to increase while the market for second-line ICI decreases. As an increasing percentage of patients entering the second line are ICI progressive, market research continues to point to CaboMedix remaining the agent of choice in the second line setting after any ICI combination, which we believe is largely due to the fact that it's the only TKI with a strong OS benefit per the label in the second line population. Turning to the HCC market dynamics,

This announcement marks the third tumor type that doublet combination of an immune checkpoint inhibitor and an anti angiogenic therapy may reach the market.

We find this encouraging as we think about the future potential of Cabo in combination with ISI as across a wide range of indications.

Should the combination of utensil Ism and Bevacizumab get approved in first line HCC. The HCC landscape will likely evolve in a similar fashion to that but RCC in that I see I'd therapy will move to the front line.

This would in turn increased the potential in second line setting for the TTM monotherapy market as the utilization of second line ISI monotherapy should decrease over time.

The data from our select steel phase three pivotal trial demonstrated overall survival in a broad second line population and positions Cabometyx well for growth in second line HCC. The five psi therapy moves into the first line setting.

Patrick J. Haley: Last week, Roche Genentech announced a positive study for the combination of Bevacizumab and Atezolizumab in first-line HCC, demonstrating superiority to serapinib in both progression pre-survival and overall survival. This result is notable in the context of the recent negative CHECKMATE 459 study evaluating single-agent nivolumab against serapinib in this same setting. This announcement marks the third tumor type that a doublet combination of an immune checkpoint inhibitor and an antiangiogenic therapy may reach the market for.

Changing the treatment paradigm and ultimately potentially growing the market with more effective first line therapies.

We strongly believe that many more eligible patients could benefit from cabometyx in its currently approved indications.

Cabometyx remains the number one prescribed teekay in RCC and we look forward to building on this momentum in RCC HCC and other potential indications as the Cabos incentive development program expands and progresses.

Gisela Schwab: We find this encouraging as we think about the future potential of CABO in combination with ICIs across a wide range of indications. Should the combination of atezolizumab and bevacizumab get approved in first-line HCC, the HCC landscape will likely evolve in a similar fashion to that of RCC in that ICI therapy will move to the front line. This would, in turn, increase the potential in the second-line setting for the TKI monotherapy market as the utilization of second-line ICI monotherapy should decrease over time. The data from our Celestial Phase III Pivotal Trial demonstrated overall survival in a broad second-line population and positions CobbleMedx Well for growth in second-line HCC if ICI therapy moves into the first-line setting. Changing the treatment paradigm and ultimately potentially growing the market with more effective first-line therapy

Future growth for complement RCC HCC and beyond may be driven by the outcome of our trials evaluating cabo in combination with immune checkpoint inhibitors.

Checkmate nine yard is the first of these phase III capitalized.

Combination studies, which is expected to read out in early 2020.

Our team remains highly focused and motivated to compete every day to bring the benefit of Cabometyx to all eligible patients as we continue to build the franchise.

That I will turn the call over to Gisela.

Thank you Peter I'm happy to provide a brief update on our development and regulatory progress in the quarter.

I'll start with current phase three program for Cabozantinib as a single agent or in combination with Ipi, which includes for ongoing study.

First and most advanced is checkmate Nani art.

Phase three trial comparing troublesome to next lets me volume up with Sunitinib in person RCC in all risk groups.

Gisela Schwab: We strongly believe that many more eligible patients could benefit from Cabo Medix in its currently approved indication. Cabo Medics remains the number one prescribed TKI in RCC, and we look forward to building on this momentum in RCC, HCC, and other potential indications as the Cabo Zantac Development Program expands and progresses. Future growth for CABO in RCC, HCC, and beyond may be driven by the outcome of our trials evaluating CABO in combination with immune checkpoint inhibitors. Checkmate 9ER is the first of these Phase 3 CABO-ICI combination studies, which is expected to read out in early 2020. Our team remains highly focused and motivated to compete every day to bring the benefit of Cabo Medix to all eligible patients as we continue to build the franchise.

The study completed enrollment earlier this year and his previously and as previously reported and looking forward to result in early 2020.

Jointly preparing with the BMS team our clinical development partners, we're executing study to enable expeditious future regulatory filings ones topline results available and if warranted by the data.

Three additional pivotal phase three studies Cosmic 311, 312 entry 13, that'd be initiated during the last nine months or so I'm, making excellent progress and are actively enrolling patients globally.

As a reminder, these three phase three studies include cosmic 311.

A single agent placebo controlled study in radio iodine refractory DTC was previously received for too far inhibitor.

Cosmic free 12, a phase three trial comparing the combination of comes on to independent T cell lymphoma.

Sorafenib enforcement advanced HCC.

Gisela Schwab: Thank you, PJ. I'm happy to provide a brief update on our development and regulatory progress during the quarter. I'll start with our current phase 3 program for carbamazantinib as a single agent or in combination with ICIs, which includes four ongoing studies. The first and most advanced is CHECKMATE 9ER, a phase 3 trial comparing carboxyantinib plus nivolumab with sonitinib and first-line RCC in all risk groups. The study completed enrollment earlier this year, and as previously reported, we are looking forward to results in early 2021.

And Chris Mcnally 13.

Three trial and percent RCC in patients with intermediate or poor risk for I am DC.

Comparing the triplet of comes onto a new volume uplift picking them up to the combination of new volume up and if you moment.

This is the first trial evaluating the approved new volume up and if you must combination as a comparative.

Yes, the Cubs engine of late stage development program is making great progress and we have working on further phase III concept and then look forward to updating you on these plans at the appropriate time.

[laughter].

In addition cost me go to one phase one study of Cabozantinib entities are Lima continues to make excellent progress.

Gisela Schwab: We are jointly preparing with the BMS team, our clinical development partners who are executing the study, to enable expeditious future regulatory filings once top-line results are available and, if warranted by the date, Three additional pivotal phase 3 studies, COSMIC 311, 312, and 313, that we initiated during the last nine months or so are making excellent progress and are actively enrolling patients globally. As a reminder, these three Phase III studies include COSMIC-311, a single-agent placebo-controlled study in radioiodine refractory DTC patients who have previously received FETCHFR inhibitors. Cosmic 312, a phase 3 trial comparing the combination of cabozantinib and daizolizumab with serapinib in first-line advanced HCC, and COSMIC 313, our phase 3 trial and first-line RCC in patients with intermediate or poor risk for IMD-C.

The study has been occurring patient actively across 20 expansion cohorts and we are seeing encouraging early results and different tumor indications.

As a reminder, the key objective of the expansion cohorts is that objective response rate per reduced version 1.1.

Notably early data from the MCR PC cohort in patients who have received one novel hormonal therapy and could have received prior to protect certainly hormone sensitive stage.

The resulted an expansion of this cohort.

Additionally, our steady oversight committee is also recommended expansion of the immune checkpoint inhibitor progressive non small cell lung cancer cohort.

This gord includes patients who have received in failed prior standard chemotherapy.

Immune.

Checkpoint inhibitor together or in sequence.

Both scored actively enrolling an additional 50 patients to for the evaluate the early evidence of activity seen among the first 30 patients involved.

Gisela Schwab: Comparing the triplet of carboxyantinib and nivolumab plus ipilimumab to the combination of nivolumab and ipilimumab. This is the first trial evaluating the approved Nivolumab and Ipilimumab combination as a comparator. So the Capizanginib late-stage development program is making great progress, and we are working on further phase 3 concepts, and I look forward to updating you on these plans at the appropriate time. Cough, Cough, Cough.

Yes.

Additionally, we have added four new cohorts oxy RPC patients to this steady, bringing the total number of cohorts in the steady to 24.

Including two cohorts evaluating the combination of comes on to dip into two selling them up and two cohorts evaluating single agent Cup was on tonnage or is it in this indication.

Gisela Schwab: In addition, COSMIC-021, a Phase 1b study of carbazantinib endothelializumab, continues to make excellent progress. The study has been accruing patients actively across 20 expansion cords, and we are seeing encouraging early results in different tumor indications. As a reminder, the key objective of the expansion court is the objective response rate per resist version 1.1.

These latter two cohorts aim to characterize the single agent activity of Cabozantinib or it is Elizabeth.

The same patient population with metastatic see RPC visceral disease or measurable extra pelvic lymph nodes, who have received word pryor and Cherokee and could have received prior to detect hill for home on tentative disease.

We are excited about the progress in the trial, but we are working hard on advancing the product comes into play stage development.

Gisela Schwab: Notably, early data from the MCRPC cohort in patients who have received one novel hormonal therapy and could have received priodetoxitaxel in the hormone-sensitive state have resulted in an expansion of this cohort. Additionally, our Study Oversight Committee has also recommended expanding the immune checkpoint inhibitor progressive non-small cell lung cancer cohort. This score includes patients who have received and failed prior standard chemotherapy and prior immune checkpoint inhibitors together or in sequence. Both cohorts are actively enrolling an additional 50 patients to further evaluate the early evidence of activity seen among the first 30 patients enrolled. Additionally, we have added four new cohorts of CRPC patients to this study, bringing the total number of cohorts in the study to 24, including two cohorts evaluating the combination of cabozantinib and atezolizumab and two cohorts evaluating single-agent cabozantinib or atezolizumab in this indication. These latter two cohorts aim to characterize the single-agent activity of cabozantinib or atazolizumab in the same patient population with metastatic CRPC with visceral disease or measurable extrapelvic lymph nodes who have received one prior NHD and could have received prior death-detecting cells for hormone-sensitive disease.

May include future phase three trial in various indications, including the mentioned see RPC and non small cell lung cancer setting if warranted by the data.

On the regulatory side.

[laughter].

On the regulatory side, there has been lot of progress.

I was on generic worldwide.

Jordan incident has continued regulatory submissions in it you addressed to for all territories and to date has obtained regulatory approvals for Cabozantinib and 48 countries, including the most recent first line RCC approval and Canada, a couple of weeks ago.

And then Japan, our partner Takeda completed in India filing with the Japanese regulatory authority for Cabozantinib in the treatment of patients with advanced RCC in April of 2019, and we look forward to updates on their regulatory progress.

And with that I will turn the call back to Mike.

All right. Thanks, Keith one exelixis maintained strong momentum in the third quarter of 2019 across all components of our business.

The dynamic nature of both RCC and HCC markets, especially in the context of each individual first line setting provides an opportunity for potential upside with cabometyx in these important patient segments.

We await the topline results for checkmate nine yard in first line RCC and the prospects for first line for ICI based therapies moving into the first line HCC setting.

Gisela Schwab: We are excited about the progress in the trial, while we are working hard on advancing the broader carbazanginib late-stage development, which may include future phase three trials in various indications, including the mentioned CRPC and non-small cell lung cancer settings, if warranted by the data. On the regulatory side, there has been a lot of progress for carbazanginib worldwide. Our partner Ibsen has continued regulatory submissions in its EU and rest of world territories and, to date, has obtained regulatory approvals for Kabazon TINIP in 48 countries, including the most recent first-line RCC approval in Canada a couple of weeks ago. And in Japan, our partner Takeda completed an NDA filing with the Japanese Regulatory Authority for Kabuzantanib and the treatment of patients with advanced RCC in April of 2019. And we look forward to updates on their regulatory progress. And with that, I will turn the call back to Mike. All right. Thanks.

Notably we continue to see strong revenue in third quarter 2019, due to the strength of the Cabometyx business in the face of significant competition from ICI based combinations and its ex us performance with Ipsen.

Notable that the Cabos dancing in franchise achieved more than $1 billion in global net product revenue over four consecutive quarters for the first time in third quarter 2019.

With this significant momentum exelixis remains a compelling opportunity for potential long term growth as we continue to invest in R&D with current and future accomplish the incentive label labeling trials and new product candidates.

I think everyone to next to what's this for the hard work and collaborative spirit as we navigate the opportunities that lie ahead. The entire team is focused to make 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. Thank you for your continued.

Michael M. Morrissey: All right. Thanks, Gisela.

Michael M. Morrissey: Exelixis maintained strong momentum in the third quarter of 2019 across all components of its business. The dynamic nature of both the RCC and HCC markets, especially in the context of each individual first-line setting, provides an opportunity for potential upside with Cabamedics in these important patient segments. We eagerly await the top-line results for CHECKMATE-9-ER and Firstline-RCC and the prospect of Firstline for ICI-based therapies moving into the Firstline-HCC. Notably, we continue to see strong revenue in third quarter 2019 due to the strength of the Complementix business in the face of significant competition from ICI-based combinations and its XUS performance with. It's notable that the Cabo Santander franchise achieved more than $1 billion in global net product revenue over four consecutive quarters for the first time in third quarter 2019.

Support and interest in Exelixis, and we're happy to now open the call for questions.

As a reminder to ask a question you want me to press Star one on your telephone to withdraw your question press the pound key please standby way compiled the Q and a roster.

Your first question comes from the line of and D.C.N. from William Blair. Please proceed.

Great Congrats on the progress and thank you for taking my questions.

Just a first one.

Just wondering if it can educate us on the IP litigation process.

So upon the.

Filing of the lawsuit that really triggers the 30 months day, which.

So my calculation will probably incurred in.

Michael M. Morrissey: With this significant momentum, Exelixis remains a compelling opportunity for potential long-term growth as we continue to invest in R&D with current and future Cabo Santanib labeling trials and new product candidates. I want to thank everyone at Exelixis for their hard work and collaborative spirit as we navigate the opportunities that lie ahead. The entire team is focused on making 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. Thank you for your continued support and interest in Exelixis. And we're happy to now open the call for questions.

Late first quarter of 2020 and.

So what's what are some potential scenarios after that or even before that and what I am really trying to understand is can you bring for additional lawsuits for example.

Specifically addressing the formulation patents that expires in 2033.

Yes, Hi, Andy It's a it's Mike let me, let me try and parsed out for you with the best I can.

Yes, one one note.

To start to is that we certainly weren't surprised by receiving the the letter on the Anda.

As you know most most successful small molecules. This is a normal part of the process. We've been well aware that we have been planning on that and prepared for that really going back 12, 18 months or some so so we've been very well.

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. Your first question comes from the line of Andy Sieh from William Blair. Please proceed.

Michael M. Morrissey: Great, congrats on the progress, and thank you for taking my questions. For the first one, I was just wondering if you could educate us on the IP litigation process. So upon the filing of a lawsuit that really triggers the 30 months stay, which based on my calculation will probably occur in, you know, late in the first quarter of 2020. And so what are some potential scenarios after that or even before that? And what I am really trying to understand is whether you can bring forth additional lawsuits, for example, specifically addressing the formulation patent that expires in 2033?

Focused on making sure that we had all the pieces in place to be able to very efficiently and I think very appropriately addressed these issues as we expected them to come up okay. So thats. The first thing second thing is we've got a strong strong team internally and externally as part of their process of illegal.

Experts to be able to address this for us so I feel very good about the team we've gotten place and certainly a high degree of confidence in both the IP and the data we have that supports the IP and enables the IP.

Michael M. Morrissey: Yeah, Andy, it's Mike. Let me try and explain that to you the best I can. I guess one note to start is that, you know, we certainly weren't surprised by receiving the letter on the ANDA. As you know, for most successful small molecules, this is a normal part of the process. You know, we've been, you know, well aware of that. We have been planning for that and prepared for that really going back, you know, 12, 18 months or so. So, we've been very focused on making sure that we had, you know, all the pieces in place to be able to very efficiently and, I think, very appropriately address these issues as we expected them to come up. Okay.

As we go forward.

In terms of our.

See litigation tactics and strategy I really don't want to see more than what we said in the queue and the press release and in my prepared remarks.

Finally, we don't want to litigate this publicly.

And we want to let the team of legal experts that we have do their jobs behind the scenes and be as effective as they can without media, enabling the the other parties involved in and what we're thinking about doing so so look at this as a first step on the process and as we as we.

Hit other milestones that we believe and material, we'll be sharing that information with certainly the sell side and investors as we go forward.

Okay fair enough its kind of moving onto the Cabometyx franchise.

Michael M. Morrissey: So that's the first thing. The second thing is, you know, we've got a strong, strong team internally and externally as part of that process of legal experts to be able to address this for us. So I feel very good about the team we've got in place and certainly have a high degree of confidence in both the IP and the data we have that supports and enables the IP as we go forward. In terms of our, I would say litigation tactics and strategy, I really don't want to say more than what we've said in the queue and the press release and in my prepared remarks. Obviously, we don't want to litigate this publicly, and we want to let the team of legal experts that we have do their jobs behind the scenes and be as effective as they can without, you know, me enabling the other parties involved in what we're thinking about doing. So look at this as a first step in the process, and as we, you know, hit other milestones that we believe are material, we'll be sharing that information with the sell side and investors as we go forward.

Just curious how you think about maybe the relative pack to fees.

Two components one is.

Calculation I think the gross to net this quarter is about 20% higher than.

What previously.

We've observed and also that.

Patient dynamic that I think PJ.

Elegantly laid out is basically pembro actually kind of holding patients long during the first line setting.

Spanning the prevalence of few well.

So kind of.

Maybe help us kind of parse out. These these two components, yes. Thanks for the question why do we have Chris talked about the gross to net issues and then we'll go back to PJ to refrain and talk about some of the some of the patient first line second line transition issues Chris.

Thanks, Mike So Andy as Chris.

I guess the best way to describe is there last quarter. It was in the mid 19% range, we did talk about.

Michael M. Morrissey: Okay, fair enough. So kind of moving on to the Calblematics franchise, curious how you think about maybe the relative impact of these two components. One is, you know, based on my calculation, I think the gross net this quarter is about 20% higher than what we've observed previously. And also, that patient dynamic that I think PJ elegantly laid out is basically Pembro actually kind of holding patients longer in the first line setting and expanding the prevalence, if you will. So, kind of.

We're expecting the year to come out around 20% you're right in saying that this quarter was around 20% and what we did see during the quarter was that we saw the Phs 30, 40 be volume or utilization increase and also the discount the required discount that's related to that.

That 340 B.

Segment of the of the payer increase awesome.

Okay great.

Hi, Andy it's it's PGN I'll tackle the second part of your question.

So yeah as you mentioned, what we've observed is in the first line setting the I see I combinations, particularly driven by the recent launches of the CIO guys.

Christopher J. Senner: Yeah, so thanks for the question. Why don't we have Chris talk about the growth?

Z in particular has really come to take a lot of first one share. So in the meantime, as expected the Sicad monotherapy first line share came under pressure in what we saw.

Christopher J. Senner: Thanks for the question.

Christopher J. Senner: to reframe and talk about some of the patient first line, second line transition issues.

Christopher J. Senner: Thanks Mike. So Andy, it's Chris.

Christopher J. Senner: I guess the best way to describe it is that last quarter it was in the mid-19% range. We did talk about

In the latter part of the quarters Cabometyx Cabometyx first line sure stabilizing.

Christopher J. Senner: Yeah.

Christopher J. Senner: We're expecting the year to come out around 20%. You're right in saying that this quarter was around 20%. And what we did see during the quarter was that we saw the PHS 340B volume or utilization increase and also the required discount that's related to that 340B segment of the figure.

Certainly the.

That sort of market acceptance of.

See I Teekay is encouraging to us, particularly in the community setting as we think about the.

Results coming for 90, our early next year.

And really what that does from the transition in first line to second line.

Patrick J. Haley: Okay, great. Hi, Andy, it's PJ, and I'll tackle the second part of your question. So yeah, as you mentioned, what we've

Therapy is that's adding that sort of four to five months that both Mike and I referred to as those patients.

Patrick J. Haley: As you mentioned, what we've got

Patrick J. Haley: In a first-line setting, the ICI combinations, particularly driven by the recent launches of the ICI TKIs, PEMAXI in particular, have really come to take a lot of first-line shares. So in the meantime, as expected, the TKI monotherapy first-line share came under pressure as we saw in the latter part of the quarter as CaboMedx first-line shares stabilized. Uh, certainly the, uh... That sort of market acceptance of ICI TKI is encouraging to us, particularly in the community setting, as we think about the results coming for 9ER early next year. And really, what that does from the transition from first line to second line therapy is that it adds that sort of four to five months that both Mike and I referred to as those patients have a longer PFS on the combination. So it'll take a bit longer to reach the second line setting.

Have a longer PFS on the combination.

We'll take a bit longer to to reach the second line setting.

In the second line setting Cabometyx is still capturing the majority of these patients and certainly our market research and discussions with the Cana wells indicate that that will continue to be the case.

And that will capture the majority of ISI progressors in the second line. So we see that.

Is that market continues to too.

Be dynamic and is not at steady state, we see that as a continued.

Opportunity for potential growth for Cabometyx.

Alright.

Great. Thanks.

Additional color I'm really appreciate.

So you're all your answers.

Great Andy Thank you.

Thank you. Your next question comes from the line of Michael Schmidt from Guggenheim. Please proceed.

Patrick J. Haley: In the second line setting, Cabo Medics is still capturing the majority of these patients, and certainly all our market research and discussions with the KOLs indicate that that will continue to be the case, that we'll capture the majority of ICI progressors in the second line. So we see that that market continues to be dynamic and is not in a steady state. We see that as a continued opportunity for potential growth for Cabo Medics.

Hey, guys. This is Charles do on for Michael Schmidt, Thanks for taking the questions as a bit of a follow up to the previous question a bit of a multi part or here how should investors think about the cabo trajectory going forward and both RCC and HCC based on recent volume and sales trends and how much of this clinical backup.

Patrick J. Haley: All right. Great. Thanks for the additional color. I really appreciate all your answers.

Log of patients are you seeing in the front line that could eventually become eligible for cattle in the second one how long do you think this will take two to reach this study state that you referred to thank you.

Operator: Thank you. Your next question comes from the line of Michael Schmidt from Guggenheim. Please proceed.

Patrick J. Haley: Hey guys, this is Charles Zhu on behalf of Michael Schmidt. Thanks for taking the questions. As a bit of a follow-up to the previous question, a bit of a multi-parter here. How should investors think about the Cabo trajectory going forward for both RCC and HCC based on the recent volume and sales trends? And how much of this, quote unquote, backlog of patients are you seeing on the front line that could eventually become eligible for Cabo on the second line? How long do you think this will take to reach this steady state that you referred to? Thank you.

Yes, thanks for the question Charles.

It certainly want to avoid get it giving any.

Sort of guidance forward looking but I guess the wed.

Frame. It has a couple of things with regards to RCC as I mentioned, what we've seen in that first line market share stabilize.

Last quarter for Cabometyx and as the first line combination Mark.

Market has really.

Become dominated by I see I combinations.

Patrick J. Haley: Yeah, thanks for the question, Charles. I certainly want to avoid getting given any, you know, sort of guidance forward looking, but I guess the way I'd frame it as a couple things. With regard to RCC, as I mentioned, what we've seen is that first-line market share stabilized last quarter for Cabo Medix. And as the first-line combination market has really become dominated by ICI combinations, most of them have yet to progress to the second line. So we think that will provide growth potential for Cabo Medix in the second-line setting moving forward. I wouldn't want to attempt to predict the timing of that, but it's clear that the market has yet to reach steady state, and that could take some time to happen, which would give Cabo Medix potential for some time.

Most of them have yet to progress to the second line. So we think that will provide.

Growth potential for Cabometyx in second line setting moving forward I wouldn't want to attempt to predict the timing of that but it's clear that the market has yet to reach steady state and that could take some time to happen, which.

Which would give cabometyx potential.

For some time there in the in HCC, it's sort of a similar.

Dynamic that could potentially play out.

With the utensil that study being positive we could see immune checkpoint inhibitor therapy now moving to the first line setting.

Patrick J. Haley: In HCC, it's sort of a similar dynamic that could potentially play out. With the AtenzoVeb study being positive, we could see immune checkpoint inhibitor therapy now moving to the first-line setting. We'll look forward to seeing that data in the coming months.

Look forward to seeing that data in the coming months and.

That could really change that first line landscape in a couple ways first of all Teekay guys are the standard in first line HCC now so I see I combination therapy.

Patrick J. Haley: And that could really change that first-line landscape in a couple ways. First of all, PKIs are the standard in first-line HCC now, so ICI combination therapy could then become the standard of care in the first line. So that could potentially bring more patients into the first-line setting from sort of the local regional therapy setting. And then what that will do is decrease, over the long term, the ICI market in the second line and provide more potential in second line HCC for TKI monotherapy where Cabo is really well positioned and is performing well. We drew HCC in Q3, and we really look at the HCC market as a market that needs to be built, which is what we've always said, and an opportunity for potential growth in the future for Cabo, both in the second line and then certainly, we look forward to the result of the Checkmate 312 study in Firstline HCC as well.

And then become the standard of care in the first line, so that could potentially bring more patients into the first line setting from sort of the local regional therapy.

Setting and then what that will do is decreased over the long term.

The ITI <unk> market in the second line and provide more potential in second line HCC for Teekay monotherapy, where cabos really well position is performing well.

Through HCC.

In Q3, and we really look.

Look at the agency market as a market that needs to be built which is what we've always said and opportunity for potential growth in the future for Cabo both in the second line and then certainly will.

Look forward to the results of the Checkmate three one to study in first line HCC as well.

Okay, great doesn't make sense on checkmate 90, or Theres, obviously, a bar for clinical success represented by Sutent, but obviously there are other IC ice in front line what are your thoughts around what cattle Nivo may need to report in order to be competitive knowing the clinical but also on the commercial sense. Thank you.

Michael M. Morrissey: Okay, great. That makes sense. On Checkmate 90-R, there's obviously a bar for clinical success represented by SUTINT, but, you know, obviously, there are other ICIs in the front line. What are your thoughts around what Cabo Nevo may need to report in order to be competitive not only in the clinical but also in the commercial sense? Thank you.

Michael M. Morrissey: Hey, it's Mike. Yeah, you know, we get that question a lot. And, you know, it's just not appropriate for us to speculate on, you know, what that might look like, where the bar is. Obviously, the data for, you know, Keynote 426 is out there. Everybody knows kind of where that stands from a competitive point of view in terms of both the PFS and survival benefits. So, but what exactly we'll see there, how much different it has to be, et cetera. You know, I think we'd much rather wait for the data to come out and be able to discuss that data in the context of all the competitive offerings that are available right now for First Line RCC.

Hey, it's Mike we get that question a lot and.

It's just not appropriate for us to speculate on what that might look like where the bar is obviously the data for.

For Q4 to six.

Is out there everybody knows kind of where that stands from a from a competitive point of view in terms of both the PFS and survival benefit so what exactly will see there how much different it has to be et cetera, I think we'd much rather wait for the data to come out and to be able to discuss that data in the context of all the competitive offerings that.

I will be eligible right now for first line RCC.

Understood last one from me.

Thank you see a few new expansion cohorts from cosmic so to one Im also kind of wondering what does the thinking or the decision tree behind I guess, adding patients to an existing cohort versus deciding to open up additional expansion cohorts versus going for a pivotal trials coming out of this thanks.

Gisela Schwab: Okay. Last one from me. So I think I see a few new expansion cohorts from COSMIC-021. I'm also kind of wondering what the thinking or the decision tree behind adding patients to an existing cohort versus deciding to open up additional expansion cohorts versus going for a pivotal trial coming out of this. Thanks.

Yes, thank you for the questions and assist Gisela.

We are obviously quite encouraged by the early data observed.

Activity and safety.

The Cosmical Q1 initial cohort.

That is sparked the expansion now two cohorts and B and C RPC setting and the ITI pretreated non small cell lung cancer setting.

Gisela Schwab: Yeah, thank you for the questions. This is Gisela.

Gisela Schwab: We are obviously quite encouraged by the early data observed both on activity and safety from the COSMIC-L2-1 initial cohorts, and that has sparked the expansion now into cohorts in the CRPC setting and in the ICI pretreated non-small cell lung cancer setting. This is really intended to better understand and further expand the experience in these indications for the combination. The addition of the cohorts that I described for prostate cancer is really intended to address multiple things. One, the activity of single agents to address the contribution of components, and to do so with concurrent randomization to patients receiving the combination therapy. So that is the plan here, and we are very encouraged by the early data.

This is really intended to better understand in free there.

Bonding experience.

These indications for the combination.

The addition of the cohorts that I described for prostate cancer is really intended to address.

Multiple things one.

The activity of single agents.

Address the contribution of component.

To do so.

With that concurrent randomization to patients.

Receiving the.

Combination therapy, so that is the plan here.

Very encouraged by the early data.

Gisela Schwab: Got it. Thank you very much for taking the questions.

Got it thank you very much for taking the questions.

Thank you. Your next question comes from the line of sales Entercom from Oppenheimer. Please proceed.

Operator: Thank you. Your next question comes from the line of Silvan Tuerkcan from Oppenheimer. Please proceed.

Hi, Thank you for taking my question. Thanks, Congrats on the quarter.

Patrick J. Haley: Hi, thank you for taking my questions and congrats on the quarter. I just want to drill down a little bit more on the cabometics sales. So if I look at the PFS increase of the ICI and TKI combo that was approved, I see 15.1 months versus 11 months, so a four month increase in PFS. So would I be correct in thinking that, well, obviously, with checkpoint inhibitors, there's a long tail, but would I be correct in thinking that maybe one, two more quarters would be enough to reach equilibrium in the market of patients flowing into second line?

Just.

Just wanted to drill down a little bit more on the Cabometyx sales. So if I look at the PFS increase of.

Okay.

As approved.

<unk>.

One month.

Four months, increasing PFS so.

Correct in thinking that.

Well, obviously with Uh huh.

Tail, but.

Well I'd be correct in thinking that maybe one two more quarters will be enough to reach equilibrium.

In the market patients.

Yeah.

Yes silver in this is PJ I wouldn't I wouldn't want to speculate exactly on the timing of that but I think what's what's clear is that the market hasn't reached steady state and that could certainly take.

Patrick J. Haley: Yeah, Silvan, this is PJ. I wouldn't want to, you know, speculate exactly on the timing of that. But I think what's clear is that the market hasn't reached steady state, and that could certainly take some time, as I've mentioned, given, as you referred to, the PFS increase of Pemaxi and their relatively recent launch. And that certainly gives Clovematics potential to continue to grow in a growing second-line RCC TKI monotherapy market.

Some time.

As I've mentioned given.

As you referred to the PFS increase of Pemex C and they're relatively recent launch.

And that certainly gives.

Telematics potential.

To continue to grow and a growing second line.

RCC Teekay monotherapy market.

Michael M. Morrissey: Great. Thank you.

Great. Thank you and then in terms of for your BD, you have quite impressive amount of cash.

Michael M. Morrissey: And then, in terms of your BD, you have quite an impressive amount of cash. You have very early partnerships. You're expanding your, I'd say, mid-line, mid-pipeline with Cosmic 021. You have some late-stage assets also coming out early next year. So what's your focus here, and has anything changed with the ANDA filing?

Early partnerships, you expanding yard I'd say midline mid.

Hi, Brian with costs May go to one.

Some of these stage assets also reading out early next year. So what's what's your focus here.

Changed with beyond the filing.

Michael M. Morrissey: Yes, Mike. As I said before, on the question from Andy, again, the ANDA filing wasn't a big surprise to us and has had no impact on our thinking around BD. As we've talked about consistently over the last several calls, we continue to, I think, proceed in a very thoughtful and pragmatic fashion to be able to look for mid and potentially late stage assets, if not commercial assets, that we think are attractive from a clinical, commercial, and competitive standpoint. You know, we have a broad search and diligent effort ongoing to find assets in what's arguably a pretty competitive space, i.e. oncology and, you know, chemo-onc, if you will, and that will continue. So, look, we're very diligent here. We're being very careful and pragmatic about how we proceed.

Yes, Mike So as I as I said before on the question for Andy again, the Anda filing wasn't a big surprise to US and has had no impact on our and our thinking around BD as we've talked about consistently over the last several calls we continue to.

I think proceed in a very thoughtful and pragmatic fashion to be able to look for men and potentially late stage assets, if not commercial assets that we sent our attractive from a clinical.

Commercial and competitive situation.

We have a broad search and diligent effort ongoing.

Find assets in what's arguably a pretty competitive space comedy and Keybanc, If you will.

That will and that will continue so look we're very diligent here, we're being very careful and pragmatic about how we proceed.

Michael M. Morrissey: We don't want to rush into a bad deal. We don't want to go after assets that don't make sense to us and certainly don't want to overpay either. So we're moving forward in a way that we think is appropriate based upon being good stewards of shareholders' dollars and making sure that we can maximize the value of any investment that we make going forward.

We don't want to rush into a.

A bad deal we don't want to go after assets that don't make sense to us and certainly don't want to overpay either so we're moving forward in a way that we think is appropriate based upon being good stewards of the shareholders dollars and making sure that we can maximize the value of any investment that we make going forward. So as we make more progress than we and we do some of these try.

Michael M. Morrissey: As we make more progress and we do some of these transactions, we'll be sure to speak about that with investors in a public setting.

As actions will be sure to speak about that with with investors in a public setting.

Great well congrats on the quarter and looking forward to all the read outs.

Michael M. Morrissey: Great. Well, congrats on the quarter, and I'm looking forward to all the readouts early next year. And thanks for taking my...

Thanks for taking my question.

Operator: You bet, Silvan. Thank you. Thank you. Your next question comes from the line of Kennan McKay from RBC Capital Markets. Please proceed.

Excellent. Thank you.

Thank you.

Next question comes from the line of Kennen Mackay from RBC capital markets. Please proceed.

Gisela Schwab: Hi, thanks for taking the question. First, on Checkmate 90R, just looking at the differences in baseline characteristics between the other IO plus And I think it's interesting that we have a lot of CKI frontline RCC trials and other I.O. trials. It strikes me that Merck really stacked the deck, so to speak, in their Kino 426 trial with 30% of the patients there having low-risk diseases. That could have padded PFS numbers, maybe OS numbers, at least at the median. And it's sort of the highest proportion of any other I.O. Trial

Hi, Thanks for taking my question first on the check that 90 are just looking for differences in baseline characteristics in the other audio plus to carry out front line RCC trials and other auto trials. It strikes me that Merck really stuck the deck so to speak in there for 26 trial with 30% at the Solutionstar, having low risk disease.

Other could try to PFS numbers, maybe a rough numbers at least a comedian and it's sort of the hottest proportion of any other higher trial.

Gisela Schwab: I guess as we think about Checkmate 9ER, is that 30% low-risk proportion set by Merck an appropriate bar to think about? And sort of on that same note, as we're thinking about a frontline label for CABO, AXI's label doesn't include the Pembroke combo data. I just wanted to make sure that CABO's label would include the Checkmate 9ER data if that trial is successful and if that indication is ultimately FDA approved.

We think about checkmate 90 hours that 30%.

Low risk proportions up by Merck is an appropriate artist think about nine youre.

Sort of all not say note as we're thinking about frontline label for although axes label doesn't include the Pembroke combo.

Just wanted to make sure that Cabos label would include the check they noted our data if that is if that trial is successful.

Syndication is ultimately have to approved.

Yes. The scheme. The thank you for the question I think you hit on a very important coin gen that it's really that it's difficult to compare cross trials because.

Gisela Schwab: Yeah, this is Gisela. Thank you for the question. I think you hit on a very important point, and that is really that it's difficult to compare across trials because patient baseline characteristics can vary and can influence outcomes. So, with respect to your question on what to expect in CheckMate 9ER, obviously, we're awaiting the data, so we can't really speak to that at this current time. And so we look forward to sharing the data, of course, when available, and they're expected early next year. I think, in terms of your regulatory question, that inclusion of data and indications and labels is obviously driven by regulatory submissions and the intent of the company to pursue that labeling. And so that's as far as I can go. I think I indicated that we are working very collaboratively with our clinical development partner, BMS, and preparing for such findings when the time comes.

Patient baseline characteristics can dairy and can influence outcome. So.

With respect to your question on what to expect and Checkmate 90, obviously, we're awaiting the data show and really speak to that at this current time.

And so we look forward to sharing the data of course when available.

And there are expected in early next year in terms of your regulatory question.

Net and.

Inclusion and.

Page and indications enables is obviously driven by regulatory submission and the intent the company to.

Pursue that.

Labeling and so.

Okay.

As far as second goal I think.

Indicated that we are working very collaboratively with our clinical development partner BMS.

Caring for such findings.

When the time comes.

Got you Okay. Thanks to fund maybe a follow up question for Chris The charts you heard the cross it shows of the Teekay high market shares where is a certain bertrand still holding share in RCC and if the growth opportunity for Cabo ahead of.

Patrick J. Haley: Thanks Kisan. Maybe a follow-up question for Chris. In the charts, or in the graphs you've shown of the TKI market shares, where is Suta and Botrian still holding a share in RCC, and is the growth opportunity for Cabo ahead of Cabo Nevo Combo? Is it fully muffling out those other TKIs?

Cabo Nivo combo, we've got flooring muscling out those other two Terry eyes, and how you do that from a marketing and medical education perspective. Thanks again.

Patrick J. Haley: And how do you do that from a marketing and medical education perspective? Thanks again.

Patrick J. Haley: Yeah, this is PJ. I'll address that question. So, first of all, the prescription data charts we're showing are for all indications there, so some of the suten and votrian volume certainly for other indications so it's difficult to kind of parse that out by by those segments. That said, you know, we see Cabo Medics competing well with those other TKIs, Sutton and Votrient, really across clinical risk groups and performing well relative to them as you can see from the data and we certainly view continuing to compete with them in the first-line setting for patients that, you know, for some reason may not be appropriate for an ICI combo as a high priority and competing for every eligible patient in RCC in addition to first line in the second line setting, particularly in the ICI experienced setting.

Oh, Yeah. This is PJ ill address that question. So first of all the the.

Prescription data charts, we're showing our for all indications there so some of the.

Sutent and vote treatment.

Volume certainly for other indication so it's difficult to kind of parse that out by by those segments that said.

You know, we see cabometyx competing well with those.

Other teekay sutent and vote shouldn't really across.

Clinical risk groups and performing well relative to them as you can see from the data and we certainly view continuing to compete with them in the first line setting for patients that.

You know.

For some reason may not be appropriate for and I see I combo as a high priority and competing for Ellie every eligible patient in RCC.

In addition to first line in the.

In the second line, saying, particularly in the ITI experienced setting.

Thank you.

Patrick J. Haley: Thank you. Your next question comes from the line of Yaron Werber from Cowan. Please proceed.

Your next question comes from the line of your own wherever from Cowen. Please proceed.

Patrick J. Haley: Great, thanks team, and thanks for taking our questions. So maybe just the first question, I don't know if you can, if possible, give us a little bit of a sense for HCC, what are you seeing in terms of growth, maybe quarter over quarter or since launch? I think in the last two quarters you've given us some sort of language on that. And then I have a couple of follow-ups as well.

Great. Thanks team and thanks for taking my questions. So maybe just the first question I don't know few king if possible give us a little bit of a sense in HCC.

What are you seeing in terms of growth maybe quarter over quarter or since launch picking the last two quarters, you've given us some sort of language on that and then I've a couple of follow ons as well.

Patrick J. Haley: Hi Yaron, this is PJ. So with regard to HCC, we're very pleased with the performance since our launch in January. What we're seeing is really similar in terms of the proportion of our business in HCC to the first couple quarters we've talked about, and HCC... continued to grow for us in Q3, which we're very pleased with. You know, I think as we look forward, we view HCC as a market that'll be built as more and more better therapies potentially come to market, with Tezzo Bev potentially getting approved in the first line setting. As I kind of mentioned, that could bring more patients into the funnel, getting systemic therapy generally. And certainly, then as ICI therapy moves from the second line to the first line and those patients transition to the second line, there will be more opportunity for TKIs where Cabo Medix is performing really well, where we have an overall survival advantage. We're really confident in our data there.

Yeah, Hi around this is a PJ so with regards to HCC, we're very pleased with the performance since our launch in January what we're seeing really is similar.

In terms of the proportion of our business.

In HCC to the to the first couple of quarters, we've talked about and HCC.

Continued to grow for us in Q3, which we're very pleased with.

I think as we look forward, we view HCC is a market that will be.

Built as more and more better therapies potentially come to market.

The test Bev potentially getting approved in the first line setting.

Kind of mentioned that could be more patients into the funnel getting systemic therapy generally.

And certainly then as I see I therapy moves from the second line to the first line and those patients transition to second line more opportunity for Teekay eyes were Cabometyx is performing really well, where we have an overall survival.

Advantage and.

Really confident in our data there.

Patrick J. Haley: Okay, so is it fair that it's a question of sort of bringing in more patients into the funnel, as you mentioned in terms of market growth, and then I don't want to call it quite vacating but sort of moving ICIs to first line and then really letting Cabo then dominate the second line setting? Is that sort of your vision?

Okay.

Is it fair that took a question of Soto.

Bringing in more patients into the funnel as you mentioned in terms of market growth and then I don't want to cold quite vacating, but sort of moving.

I see I used to first slide and entering committing capital then dominant the second line setting that sort of your vision.

Well I think.

The potential certainly there for that to happen in the relatively near term.

Michael M. Morrissey: Well, I think, you know, the potential is certainly there for that to happen in the relatively near term, as approximately half the market for the second line is currently ICI monotherapy. So as that grows, it certainly gives us a nice opportunity for potential in that second line setting in the relatively near term, before other trials, like the Cabo Atezzo study, would read out in the first.

As approximately half the market in the second line is currently.

I see I monotherapy, so as that grows.

Certainly gives us.

Nice opportunity for potential in that second line setting in the relatively near term.

Before other trials.

Like the Cabo at Tesoro study would read out in the first line.

I think so.

Michael M. Morrissey: Hi everyone, it's Mike. I think that's the way to look at it from the standpoint of how you could, you know, logically see a progression there in terms of short term, again, capturing more second line as we talked about previously, as now, in this case, the ICI combo comes in the first line. And then, you know, certainly we're very excited about 312 and what that could do relative to the first line setting. So liver is a big area of growth, potentially. We've talked about that extensively over the last couple of years, and hopefully, that will continue to be the case as time goes on and as more data comes out. And so it is.

You are on its Mike I think best way to look at it from the standpoint, and how you could.

You know logically see a progression there in terms of short term begin capturing more second line as we've talked about previously as as now in this case the IC I combo comes in the first line and then certainly we're very excited about 312, and what that could do relative to the first line setting. So livers are big area of growth essentially we've talked about that extensively over the last couple of.

Ears, and hopefully that will continue to be the case as as time goes on them and as more data comes out.

And so its cabo it's Cabo expanded the second line HCC markets. So far is that really been sort of share gains.

Patrick J. Haley: And so, has Cabo expanded the second line HCC market so far, or has it really been sort of a share game? from other drugs?

Patrick J. Haley: You know, I think what we've seen is not really market expansion as of yet in the second line setting, but we've really seen Cabo competing well, particularly with the other TKIs and taking share from the TKIs there.

Some other drugs.

I think what we've seen is really.

It's not really market expansion as of yet in the second line setting, but we've really seen.

We're competing well, particularly with the other teekay eyes, and and taking share from from the Teekay guys. There.

Christopher J. Senner: Okay, great. And maybe just a couple of things, just housekeeping in terms of any sense, you can give us a sense where inventories are. And then also the price increase in January, there's a four and a half percent. Give us a sense of how long it takes to actually see the typical sort of benefit because it didn't seem like you did a lot of it in Q3.

Okay, Great and maybe just a couple.

Just a housekeeping in terms of any sense, you can give us sense, where inventories are and then also the price increase in January that were 4.5% give us is and how long does it take to actually see you know the typical sort of benefit because it didn't seem like you've gotten a lot of it in Q3. Thank you.

Christopher J. Senner: Thank you.

Christopher J. Senner: Yaron, it's Chris. So, I guess I'll take that in two pieces. So, from an inventory perspective, our wholesaler inventory was essentially flat in Q3 versus Q2. And then on the price increase, we took a 4.5% increase on July 1, and yeah, that all came through in the quarter. Basically, what happened during the quarter is, as PJ talked about, we had a demand decline. And then the price, the price increase offset that demand decline. And basically, we ended up with essentially flat revenue from Q3 to Q2, the only difference from there is the growth net I talked about earlier during Andy's question.

Yeah, you're on it's a it's Chris so I guess I'll take that into pieces. So from an inventory perspective, our wholesale inventory was essentially flat Q3 versus Q2.

And then on the price increase we took it we took afford have set on July one.

That.

That all came through in the quarter basically what happened during the quarter as Peter talked about with demand decline.

And then that the the price the price increase offset that demand decline and basically we ended up with.

So actually flat revenue in Q3 Q2, the only differences from there is the growth that I talked about earlier Darren.

Question.

Okay, great. Thanks, so much appreciated.

Christopher J. Senner: Okay, great. Thank you so much. I appreciate it.

Sure your own.

Thank you.

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

Operator: Thank you. Your next question comes from the line of Stephen Willey from Stiefel. Please proceed.

Yeah. Good afternoon, thanks for taking the questions.

Maybe a couple of questions for PJ and appreciate the commentary regarding some of the market share.

Patrick J. Haley: Yeah, good afternoon. Thanks for taking the questions. Maybe a couple of questions for PJ, and I appreciate the commentary regarding some of the market share dynamics, but I was curious if you've seen anything with respect to Linvatinib in renal cancer. I know Merck yesterday, I guess, called out renal as kind of a driver for Linvatinib sales, and I was just kind of curious. You know, just because I think most of our diligence would suggest that Linvatinib and Everolimus haven't really gotten much airtime, but I was curious if you're seeing anything in the market that would suggest otherwise.

Dynamics, but.

It was.

I was curious if youve seen anything with respect to Lenvatinib.

In renal cancer, I know Merck yesterday, I guess call though.

Reno was as kind of a driver for Olin bottom up sales and.

Well, it's just kind of curious just because I think most of our diligence would suggest that Monday and theyve been several imus hasn't really gotten much airtime, but.

I was curious if if if you're seeing anything in the market that would suggest otherwise.

Patrick J. Haley: yeah

Yeah I think.

Patrick J. Haley: Yeah, I think, you know, thanks for the question. Really, the Lenev combo, as you suggested, we really never saw that get off the ground, so to speak, getting approved a couple months after Cabo Medix did with our Meteor label. You know, what we hear from KOLs and physicians and see is that it's really just used in the salvage setting, primarily, you know, given I think the toxicity issues, etc., and they're not seeing it really compete with Kalvo Medics.

Thanks for the question.

Really they.

The wed have combo as you suggested we really never saw that.

Particularly get off the ground so to speak at getting approved a couple of months after Cabometyx did with our meet your label.

What we hear from cables and physicians and season, it's really just used in the in the salvage setting.

Primarily given I think the toxicity issues et cetera and.

No not seeing it really compete with Cabometyx.

Patrick J. Haley: Understandable, and I know that there was some, when Vatinib data was presented at ESMO, suggestive of IO retreatment, and just kind of curious as to kind of your perspective on that and whether or not you're seeing IO retreatment in the marketplace as a potential headwind to second line.

Understood and I know that there was some one that and then data presented at ESMO.

Suggestive of.

Re treatment.

And just kind of curious as to as to kind of your perspective on that and whether or not you're you're seeing io re treatment in the marketplace as as a as a potential headwind to second line.

Patrick J. Haley: Yeah, I mean, I think, you know, so there's been some variety of really small data sets presented, but we're not seeing Uh, you know, re-treatment with IO at this point. There's certainly no, um... Randomized data to suggest that there would be any rationale for doing that, so no, it's not something we're seeing.

Yeah, I mean I think.

There's been some a variety of data sets really small presented but we're not seeing.

Retreatment with Io at this point, there's certainly no.

Randomized data that suggests that there would be any rationale for doing that.

So no it's not something we're seeing.

Michael M. Morrissey: Okay, and then just lastly, with respect to HCC, just kind of curious, how do you anticipate, I guess, presuming you guys win in 3-12, how does that then kind of set up from a commercial and collaborative perspective with Roche, in terms of their being active in the market with Otezzo of Aston, and you guys also being there as well with Otezzo Cava?

Okay, and and then just lastly, with respect to HCC.

Just kind of curious how.

How do you anticipate I guess presuming you guys. When in 312, how does that then kind of set up from a.

Commercial and collaborative perspective with Roche.

In terms of there being active in the Mac.

The marketplace with potential with Aston and you guys also being there as well with Tesoro Cabo.

Michael M. Morrissey: Yeah, Steve, it's Mike. That's a great question. It's tough to speculate on that in the absence of any data, including the EMBRAVE data, and 312 is still enrolling. So, you know, there are many different levers one could imagine pulling there based upon how the data looked and based upon, you know, the differences in both activity and tolerability, etc. So, probably wise if we, you know, kind of table that question for the future once we see the different components come out. Again, what we're hearing is that we'll have EMBRAVE data. We'll see that sometime in the next month or so.

Yes, Steve its bike Thats a great question, it's it's tough to speculate on that in the absence of.

Absent of any data, including the Embraer data and 312 is still still enrolling.

So.

Theres many different levers one could imagine pulling their based upon how the data looked and based upon the differences and.

Activity and Tolerability et cetera.

So probably wise if we if we.

And a table that question.

The future once we see see the different components come out again, what we're hearing is that we'll have we'll have the embraer data, we'll see that sometime in the next month or so so that'll be a first stake in the ground and then obviously, there's lots of interest in 312 and being able to push that forward as aggressively as quickly as possible. So we're.

Michael M. Morrissey: So, that'll be a first stake in the ground. And then, obviously, there's lots of interest in 312 and being able to push that forward as aggressively and quickly as possible. So, we're excited about liver. We think that's a growth opportunity for us. And whether it be, you know, getting more second line utilization and a growing opportunity with first line growth and then following up with that with a second 312 data set, if positive, could be very exciting for us.

Said about liver, we think that's a that's the growth opportunity for us and whether it be getting more second line utilization in a growing opportunity with first line growing and then following up with that with a with a second 312 dataset if positive could be very very exciting for us.

Michael M. Morrissey: Great. Thanks for the color and congrats on the quarter.

Great. Thanks for the color and.

Congrats on the quarter.

Operator: Thank you.

Patrick J. Haley: Thank you. Your next question comes from the line of Paul Choi from Goldman Sachs. Please proceed.

Thanks, David.

Thank you. Your next question comes from the line of Paul Choice from Goldman Sachs. Please proceed.

Patrick J. Haley: Great. Good afternoon, and thank you for taking our questions. I was wondering if we could maybe dig in a little more on the transition between the first line ICI and the second line, and I appreciate that the process is still evolving, but can you maybe comment on, for the patients who have seen prior immunocheckpoint therapy, can you maybe comment on what you're seeing with regard to duration and how that's been potentially affecting duration of therapy and how that's been potentially affecting utilization of carbametics in the second line?

Great. Good afternoon. Thank you for taking your questions I was wondering forget maybe taking a little more on the the transition between the first line I see I and the second line and I appreciate that the process is still evolving but can you maybe comment on for the patients who have seen prior checkpoint therapy.

Can you maybe comment on what you're seeing with regard to duration and how thats been potentially affecting duration of therapy, and how thats been protecting potentially affecting.

Utilization of Cabometyx in second line.

Patrick J. Haley: Yeah, Paul, this is PJ, happy to address that. So, I think, you know, what we've seen over time as patients have progressed off an ICI combination, which at this point is really Nebo IP patients who have done that, is that we've seen Cabo capture the majority of the patients in the second line in that setting. As far as duration goes in that setting, it's really, I think, too early to... to kind of speculate, is that something you need? You need time and lots of data to understand fully. There's certainly been a lot of small data sets presented in You know, the activity for all the TKIs in that setting seemed reasonable, but too early to really... Ticket numbers there.

Yeah.

Paul says PJM happy to address that so I think what we've seen over time as patients have progressed, often I see I combination, which at this point is really to the nivo would be patients who have done that is we've seen.

Cabo capture the majority of the patients in the second line in that setting as far as duration goes.

In that setting, it's really happy too early to.

To kind of speculators, that's something you need any time and lots of data to understand fully.

Theres been a certainly a lot of small datasets presented in.

The activity for all the Teekay guys in that setting seem reasonable, but too early to really.

To give numbers there.

Gisela Schwab: Okay, thanks for that, Peter. And then one for Gisela. With the expansion cohorts in COSMIC-021, I guess, you know, what is the thinking with regard to timing and in terms of decision-making and prioritizing, you know, which cohorts to pursue next? And, you know, have you any sort of timeline or strategic priority with regard to, you know, which cohorts you'll advance and which ones you'll winnow or prune, potentially?

Okay. Thanks for that Peter and then one for good luck with the expansion cohorts in cosmic go to one.

I guess, what does the thinking with regard to timing in terms of decision, making at prioritizing, which cohorts to pursue next and you know is have you any set any sort of timeline or strategic priority with regards to which cohorts, you'll at bath, and which ones you hold window or are prudent potentially here.

Gisela Schwab: Yeah it's a it's a large study of course with now 24 different cohorts, different tumor types and different settings in various tumor types and it's a dynamic decision-making progress process with the first cohorts expansion being 30 patients and based upon the data observed we can make decisions with a study oversight committee to expand certain cohorts if warranted by the data both activity and safety so that is an ongoing process and a very very active process and a very active study and so in terms of prioritization we have the ability to expand multiple of those cohorts as we see the data come together.

Yes.

It's a large study of course with annual Rtwenty four different cohorts different tumor types and different settings and Barry to maturing.

And.

It's a dynamic decision, making progress process with.

For the school hits expansion being 30 patients and.

Based upon the data observed.

As we can make decisions with a steady Openstack committee to explore uncertain cohorts if warranted the data both activity and safety so.

That is an ongoing process.

Very very active process.

Very active steady.

And so it gives us prioritization, we have the ability to respond multiple dose cohorts.

As we see begin to come together.

Okay. Thank you for taking your questions.

Gisela Schwab: Okay, thank you for taking our questions.

Operator: Thank you. As a reminder, ladies and gentlemen, if you have a question, please press the star and the number one key on your touchtone telephone. Your next question comes from the line of George Farmer from BMO Capital Markets. Please proceed.

Thank you as a reminder, ladies and gentlemen, if you have a question. Please press Star then a number one key I touched on telephone.

Your next question comes from the line of choice Farmer from BMO capital markets. Please proceed.

Gisela Schwab: Hi, thanks for taking my question. Gisela, could you please comment a bit more on COSMIC-021 and how you guys think about reporting that data out over time? Do we have to wait until all those cohorts are fully enrolled?

Hi, Thanks for taking my question.

Do you slow could you comment a bit more on cosmic go to wine and how how do you guys think about reporting that data out over time.

Do we have to wait until all those cohorts are fully enrolled and complete or do you think we'll see data as each cohort cohort matures.

Gisela Schwab: We'll see data as each cohort matures.

Gisela Schwab: Thank you for the question. And I think we said before, and that's still the position, we want to present mature data. And that can be for individual cohorts. So it doesn't have to be the whole study that has to mature as we move forward. And we would expect in 2020 to begin presenting such data, including the CRPC and lung cancer cohorts, but perhaps others as the data mature.

Yes. Thank you for the question and I think and improve for and that's still the position we want to present, MCU again and that can be for individual which.

Thank you have to be that hold steady that gets to mature.

As we move forward and we would expect in 2020 and we've begun.

Presenting such data.

During this year PC in lung cancer cohort.

But perhaps this.

Good day to mature.

Okay, Thanks, and PJ could you confirm again, just the impact of the I see I.

Our pieces on on.

Kibo growth.

Patrick J. Haley: Okay, thanks. And PJ, could you confirm again just the impact of the ICI therapies on CABO growth? Are you saying that those are taking over the front-line share that CABO has, or is it really more about this pushing CABO out to the second line, delaying CABO therapy into the second line?

You are you, saying that those are taking over the the frontline chair that cable has or is it really more about this pushing cable to second line, okay, pushing idling cable therapy into the second line.

Yes, Hi, George Thanks for the question I think what were what we we had a slight on we should that be I see I combinations of really.

Come to take large share in the first line setting so that's put pressure on on all the.

Patrick J. Haley: Yeah, hi George, thanks for the question. On the slide we had, we showed that the ICI combinations have really come to take a large share in the first line setting. So that's put pressure on all the TKI monotherapies in the first line, a Cabo share decline there, and then stabilized in the third quarter. So it's really just sort of taking longer for those patients to get into second line, where Cabo Medix is capturing the majority of the patients who have transitioned from first line to second line and progressed on an ICI combination therapy.

Let me all the Teekay model therapies in the first line at Cabo share decline, there and then stabilized.

In the third quarter.

So that's one dynamic and then the other piece of it is that those patients progressing off I see I combinations.

Or PFS is four or five months longer than.

Sort of the previous standard of care and personal care, taking longer to reach second line. So it's really just sort of taking longer for those patients to get into second line, where cabometyx is capturing the majority of the patients who have transitioned from first line to second line and progressed on an Io combination therapy. Okay.

Patrick J. Haley: Okay, and are there any differences between the various risk groups in RCC?

Okay and is there any are there any differences in the various risk groups.

In ours RCC.

Patrick J. Haley: Well, I mean, with regard to the risk groups, I would just, you know, refer to the clinical data. Obviously, the favorable ones tend to do better and take longer to progress. And I think that's sort of what we see in all the data that we have access to as well.

Well I mean with regards to the risk groups I would just refer to the clinical data.

Obviously, the favorable ones tend to do better.

Take longer to progress.

And I think thats sort of what we see in all the data.

We have access to as well.

Patrick J. Haley: Okay, thank you.

Okay. Thank you.

Operator: Thank you. Your next question comes from the line of Jeff Hung from Morgan Stanley. Please proceed.

Thank you Sir your next question comes from the line I was just hung from Morgan Stanley . Please proceed.

Patrick J. Haley: Thanks for taking the questions. You talked about the potential benefits of the ICI combo in front line HCC for CABO monotherapy and second line HCC, but can you talk about how EMBRAVE 150 impacts your thinking about COSMIC 312?

Thanks for taking the questions you talked about potential benefits of the I see I combo in frontline it you see for Cabo.

On a therapy in second line issue, but can you talk about how embraer 150 impacts your thinking on cosmic three one too.

Operator: Transcribed by https://otter.ai

Well I think you know generally just PJ I think obviously there is an opportunity to expand the first line market with newer better therapies and it's certainly.

Patrick J. Haley: Well, I think, you know, generally, PJ, I think, obviously, there is an opportunity to expand the first-line market with new or better therapies. And it's certainly encouraging to see an ITI and anti-angiogenic combination have a positive study in that setting where we have the Cabo Atezo 312 study, as Gisela and Mike referred to enrolling. So certainly encouraging as we think about HCC going forward. And nice to have the possibility of the pie sort of getting bigger in HCC, you know, a bigger second line opportunity for TKI monotherapy in Cabo as ICI moves forward. And, and, you know, looking forward to 312 Study Reading Out in the First Line Setting.

Certainly encouraging to see and I see I anti Angiogenic combination.

Have a positive study in that setting where where we have.

The capital intensive 312 studies, when Mike referred to enrollment so.

And encouraging as we think about HCC going forward.

Nice to have the possibility of the pie sort of getting bigger and HCC.

Bigger second line opportunity for Teekay monotherapy, Cabos Ipi moves forward and.

Looking forward to.

Three one to study reading out in the first line setting.

Michael M. Morrissey: Thanks. And then in the new year, do you plan to provide guidance on cabo sales, or how do you think about timing for providing sales guidance?

Thanks, and then in the new your do you plan to provide guidance on Cabo sales or how do you think about timing for providing sales guidance.

Michael M. Morrissey: Yeah, Jeff, it's Mike with a question. We'll talk about that in 2020. Stay tuned.

Yeah, Jeff It's Mike Fair question, we'll talk about that in 2020 stay tuned.

Michael M. Morrissey: Alright, maybe one last question though. What do you think about capital allocation with regard to maintaining profitability?

All right maybe one last question, how do you think about capital allocation with regards to maintaining profitability.

Michael M. Morrissey: Yeah, so as we talked about previously, there are both tactical and strategic reasons why being profitable is a good thing. And that's an important part of how we built the business over the last several years. We've talked, I think, pretty extensively about being able to spend more as we make more. And that's still part of the plan, too. We're in a, you know, data-driven business, more good data, but it gets, you know, more top line revenue and more profitability. So that will obviously continue. We have, I think, big aspirations for what we think we can do internally through our partnerships, through new collaborations, through companies that we might partner with or buy relative to how we can continue to build this diverse pipeline of oncology assets that we think can help a broad array of cancer patients. So that's all part of the equation. But it's, you know, it's a pretty simple formula going forward for us. You know, be careful.

Oh, yeah. So as we talked about previously there are both tactical and strategic reasons why being profitable. The good thing and that's an important part of how we built the business over the last several years.

We've talked sitting pretty extensively about being able to spend more as we make more and that's still part of the plan to weed that we are at where enough data driven business.

More good data gets.

More topline revenue and more profitability. So that we'll obviously continue we have I think the big asked me a big big aspirations for what we think we can do internally through our partnerships.

Few new collaborations through companies, but we might partner with or by relative to how we can we can continue to build this diverse pipeline of oncology assets that we think can help a broad array of cancer patients. So that's all part of the part of the equation, but it's it's a pretty pretty simple formula going forward for us.

Be careful Jeff generate revenue generate income spending wisely continue to grow the business.

Michael M. Morrissey: Generate revenue, generate income, spend it wisely, and continue to grow the business.

Operator: Great, thanks.

Great. Thanks.

Thank you.

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.

It's time there no further questions.

So I will turn the call I'll like to today's host Susan Hubbard Miss Albert Thank.

Operator: Thank you, Gigi, and thank you all for joining us today. We certainly welcome your follow-up calls. Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.

Thank you GTN. Thank you all for joining US today, we certainly welcome your follow up calls with any additional questions. You may have that we were unable to Jack during today's call.

Ladies and gentlemen. This concludes today's conference call. Thank you for participation you may now disconnect.

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