Q1 2020 Earnings Call

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unknown: The Ultimate Parody Site! Good day, and welcome to the Bristol-Myers Squibb 2020 First Quarter Results conference call. Today's conference is being recorded. At this time, I would like to turn the conference over to Mr. Tim Power, Vice President, Investor Relations. Please go ahead.

Tim Power: Thanks, Chloe. And good morning, everyone. Thanks for joining us this morning for our first quarter 2020 earnings call. Joining me this morning with prepared remarks are Giovanni Caforio, our Chairman and Chief Executive Officer, and David Elkins, our Chief Financial Officer. Also participating in today's call for the Q&A session are Chris Boerner, our Chief Commercialization Officer, Nadeem Ahmed, President of Hematology, and Samit Hirawat, our Chief Medical Officer and Head of Global Drug Development. As you'll note, we've posted slides to BNS.com that you can use to follow along with David and Giovanni's remarks, but before we get started, I'll read our forward-looking, Actual results may differ materially from those indicated by those forward-looking statements as a result of various important factors, including those discussed in the company's SEC filings. These forward-looking statements represent our estimates as of today and should not be relied upon as representing our estimates as of any future date.

Good day and welcome to the Bristol Myers Squibb, 2021st quarter results Conference call. Today's conference is being recorded at this time I would like to turn the conference over to Mr., Tim Powers, Vice President Investor Relations. Please go ahead.

Nice Chloe and good morning, everyone. Thanks for joining us this morning for first quarter 2020 earnings call.

Joining me this morning with prepared remarks, Archie Gozani before you are chairman and Chief Executive Officer, David Elkins, Our Chief Financial Officer also participating in today's call pretty cute takes action or Chris Burns, our chief commercialization Officer development cousins, Hematology and summit here Walker Chief Medical Officer.

Development.

If you look we posted slides to be enough get cold, but you can use to follow along with four David the GE that his remarks happened before we could start to the whole wheat or forward looking statement.

During this call may make statements about the company's future plans and prospects to constitute forward looking statements actual results may differ materially from data indicated by those forward looking statements that truth of the various important factors, including goes it's got to the copies of these people on me.

Giovanni Caforio: Thank you, Tim, and good morning, everyone. I hope that you and your families are healthy and coping safely through this unprecedented time. The COVID-19 pandemic is profoundly impacting our lives, families, and communities. Over the past months, our company has focused on how we can help in the global fight against the virus and effectively continue the supply of our medicines to patients globally while placing the highest priority on the health and safety of our workers. I am very proud of how our teams around the world have risen to the challenge.

These forward looking statements represent our estimates as of today and should not be relied upon as representing rest and it's not anything that's if any future date.

Giovanni Caforio: During this pandemic, it has been abundantly clear that the biopharmaceutical industry plays a critical role in the prevention and treatment of diseases like COVID-19. Governments, healthcare providers, and the public have turned to us to identify and develop diagnostic tests, effective treatments, and vaccines to prevent the Deep scientific knowledge, development expertise, and manufacturing capabilities are what will ultimately help us prevail, and I've been impressed by the collaboration and speed with which the industry is responding. On slide four, let me start with what Bristol-Myers Squibb is doing to support COVID, the global COVID response effort focused on four key areas: our science, our communities, our patients, and our. On the R&D front, we have identified approximately 1,000 compounds in our discovery library that we are making available to external researchers globally to screen for potential molecules to treat COVID-19.

Giovanni Caforio: We are evaluating certain medicines in our portfolio that could be included in near-term clinical trials, with a focus on the inflammatory immune response associated with COVID-19. We are also participating in cross-industry groups designed to foster collaboration. These include the Gates Foundation COVID-19 Therapeutics Accelerator, the California Institute for Biomedical Research, and the National Institutes of Health, among others. We have also focused our resources on how we can support

Giovanni Caforio: The Bristol-Myers Squibb Foundation has provided over 170 grants to human service organizations and patient support groups in over 20 countries around the world in order to address gaps in the response to COVID-19. We are providing personal protective equipment to health care providers on the front lines in China, Italy, and to targeted community hospitals here in the U.S. And, very importantly, we have been focused on how to support our patients. We have expanded our existing patient support programs to help eligible and employed patients in the U.S. who have lost their health insurance due to the pandemic by offering access to any branded Bristol-Myers Squibb medicine. We are working with healthcare providers in new ways through effective virtual engagement to ensure they have the support they need to treat their patients while minimizing in-person contact and the potential spread of COVID-19.

Shouldn't have provided over 170 grants to human service organizations and patients board from groups in over 20 countries around the world in order to address gaps in the response to go with 19.

We have providing personal protective equipment to healthcare providers on the front lines in China easily into targeted community hospitals here in the U.S.

Giovanni Caforio: We adjusted our clinical trial operations where needed to ensure the safety of patients, providers, and our employees and to avoid stressing the overall healthcare system. All clinical trial activities are planned to resume by the end of the year, where local country restrictions have been met. Although the impact on clinical trial timelines is still being evaluated, fully recruited trials are at lower risk of delay. I'm incredibly proud of our teams across the globe.

And very importantly, we have been focused on how to support our patients. We have expanded I would existing patient supports programs to help eligible unemployed patients in the U.S., who have lost their their health insurance you to the fanatics by offering access to any Brandon based on my screen with medicine for free.

We are working with health care providers in new ways through effective virtual engagements to ensure they have the support that they need to three to their patience, while minimizing in person calling back to end up with central spread of Kobe 19.

Giovanni Caforio: First, our essential workers continue to work at our sites to ensure our medicines reach patients who depend on them. I'm proud of their dedication. Most of our people are working from home to keep them safe and to minimize the potential spread of the virus.

We adjusted I work clinical trial ovations wherever needed to ensure the safety of patients providers and now what employees and to avoid this stressing the overall health care system.

Giovanni Caforio: We are supporting our teams with increased flexibility to ensure they have the time they need to care for those at home. Additionally, our employees who are licensed healthcare workers and wish to volunteer to provide medical services to patients during the pandemic are supported with full salary and benefits. Now, turning to the quarter.

Oh clinical trial at the T.V.D.'s are planned to resume by the end of the year when local going through the sixth sense have been lifted.

Although the impact on clinical trial fine lines is still being evaluated.

Through the trials are at <unk>.

I'm incredibly proud, although I work teams across the globe first I would essential workers going to you to work at our sites to ensure our medicines to reach patients will depend on them.

Giovanni Caforio: We had excellent performance finance, and from a pipeline perspective, let me start with the extraordinary pipeline execution in the first quarter on slide 5. We have continued to deliver very well on all key value drivers. Starting with approvals, in late March, Zyposia was approved in the U.S. for relapsing forms of multiple sclerosis with a best-in-class label.

Proud of their dedication most about where people are working from home to keep essential workers safe and to minimize the potential spread of the virus. We are supporting our teams would increased flexibility to ensure they have the time they need to care for those at home.

Giovanni Caforio: And we also received a positive CH&P opinion recommending approval for Ziposia in Europe. In April, we received FDA approval for reblozol in MDS. This is the second indication for this medicine, and we are very encouraged by the opportunity we have with this first and only EMA medicine to treat an Additionally, we just announced a CH&P positive opinion for Reblozo for both Beta Tau and MDS in Europe. With respect to submissions and filings, we received a priority review for LysoCell in third-line-class large B-cell lymphoma in the U.S., now with the PDUFA rate extended to November 6. We completed our FDA submission for IdaCell, which is an exciting next step in bringing the first CAR T candidate to adult patients with multiple myeloma.

The employees, who are licensed to health care workers, and we used to volunteer to provide medical services to patients getting the Sunday make our supported with full salary and benefits.

Now turning to the court there we had excellent performance financially.

And from a pipeline perspective, let me start with the extraordinary pipeline execution into first quarter on the slide five.

We have continued to the lever very well on the old key value drivers.

Sort of thing we'd approvals <unk> was approved in the U.S. for relaxing forms of multiple sclerosis, with the best thing class label.

And we also received a positive C.H.M.P. opinion recommending a pool foresee bows yet in Europe.

April we deceived F.D.A. approval for <unk> in M.D.S.

The second indication for these medicine and we are very encouraged by the opportunity. We have with this first and only E.M.A. man did seem to treat anemia.

Giovanni Caforio: And we very recently announced that we received a priority review for CC486 in first-line AML. And with respect to lung cancer, we received priority review in the U.S. and CHMP validation in the E.U. for Checkmate 9LA for Obdivo plus Yervoy plus limited chemo in first-line lung cancer.

Additionally, we just announced a C.H.M.P. ball C.D. will be near the for rebels, though for both <unk> and M.D.S. in Europe.

With respect to submissions and findings we received a priority to you for life herself in 30, <unk> large be settling for main to U.S. now with the balloon Friday to extend that to November 16.

Giovanni Caforio: And we're looking forward to the PDUFA for Checkmate 227 next year. Lastly, from a clinical research perspective, we recently reported positive top-line results from two positive Pivotal Phase III studies in our IOPI, Checkmate 9ER, evaluating Obdivo in combination with Cabomatics in first-line RCC, and Checkmate 743, where Obdivo plus Yervoy demonstrated a survival benefit in first-line We look forward to working with global health authorities to bring this new combination of regimens to patients who are waiting for new treatments. This has been a truly remarkable course.

We completed our F.D.A. submission for either cell, which is an exciting next step in in bringing the first <unk> two adult patients with multiple myeloma.

And we very recently announced that we received a priority debut for C.C. 486 in first line A.M.L. maintenance.

And with respect to lung cancer, we see today priority review in the U.S. and C.H.M.P. validation into you for Checkmate nine and a forum Diego last year avoid plus limited chemo first nine lung cancer.

Giovanni Caforio: All of these exciting accomplishments would not have been possible without the focus and dedication of our global partners. Moving to slide six, we've had a very good quarter financially. Despite the emergence of the pandemic, our business is strong. In the first quarter, we delivered $10.8 billion in sales.

And we're looking forward to the <unk> for Checkmates to do seven next week.

Lastly from a clinical research perspective, we recently reported also they thought blind results from do positive people with all phase three studies in our aisle pipeline checkmate nine E.R. evaluating of deal in combination with Cabometyx in first line R.C.C. and checkmate to 740.

Giovanni Caforio: Excluding COVID-related dying patterns, this represents a pro forma underlying growth of 8% versus last year. Our performance was strong across brands and geographies as a result of excellent commercial execution across the board. David will provide more details in his remarks, including the shifts we're seeing in buying patterns for some of our customers. Let me now provide more details on how we are managing the business in the current environment. Our supply chain remains intact, and we are continuing to manufacture API without a disruption. And we have a safety stock of raw materials and finished products available.

Three <unk> Diva, plus yet avoid demonstrators for Bible benefit in first line <unk>.

We look forward to working with global health authorities to bring this new combination regiments to patients who are waiting for Newsweek men options.

This has been a truly remarkable quarter.

All of these exciting accomplishments would not have been possible without the focus and dedication of our global teams.

Moving to slight seeks we've had a very <unk> financially despite the emergence from the pandemic.

Business is strong in the first quarter, we deliver $10.8 billion entails <unk>.

Giovanni Caforio: The pandemic has naturally caused some logistical complications, and we are navigating this successfully. Our integration work is proceeding well. We continue to build on the hard work from 2019 that allowed us to hit the ground running with great efficiency. We've seen an acceleration in the cultural cohesion of our new company during the work from home period, as the current environment has brought us together in even greater ways. We are on track to deliver $2.5 billion in synergies by the end of 2020. Finally, as we see countries moving to phase two of the pandemic and reopening parts of their economies, our focus has shifted to recovery. And we are accelerating planning for the restart of many of our operations. We will do this gradually as conditions evolve, while continuing to keep the safety and health of our workforce, our patients, and our communities as our highest priority.

Excluding the coffee the related buying patterns diesel represents April for my underlying growth or 8% versus last year.

Our performance was a strong across brands and geography as a result of excellence commercial execution across the board.

David will provide more details and he's very much.

Floating the shapes, we're seeing in buying patterns for some of our medicines.

Let me know provide more details on how we are managing the business in the current environments.

We're supply chain remains intact.

We are continuing to manufacture A.P.I. without the disruption and we have safety stalk overall materials and finished products available.

<unk> naturally caused some logistical implications and we have navigating this successfully.

I want integration work is proceeding well.

We continue to build on the hard work from 19 that allowed us to hit the ground running but aid with great efficiencies <unk>.

We've seen an acceleration into cultural cohesion about where new company during the work from home beaded as the current that environment has brought us together, an even greater waste. We are on track to they leave or 2.5 billion in synergies by the end up 22.

Giovanni Caforio: So looking forward, while industry-wide dynamics may create volatility in our business in the short term, and there is significant uncertainty regarding the dynamics of the evolution of the pandemic, we are executing well, we remain well positioned, and I'm excited about the potential of the conference. With that, I'll hand it over to David to walk you through our financials for this quarter and how we are thinking about our future.

Finally, as we see counter is moving to face to open up Monday make into reopening box over that are gone and I.

<unk> has shifted to recall, they and we had accelerating planning for restocked of <unk>.

We will do this gradually as conditions <unk> white continuing to keep the safety inhaled, although more water force I work patience and our communities as our highest priorities.

David V. Elkins: Thank you, Giovanni. Hello, everyone, and thanks again for joining us. I hope that you and your families are staying safe and healthy while we operate virtually. You know, as Giovanni mentioned, I'm extremely pleased with the performance of our teams during these unprecedented times. The benefits of our medicines and the strong commercial execution resulted in exceptional performance in the first quarter. Turning to slide eight, we had strong top line performance in the quarter, with global sales increasing double digits, growing 13% versus prior year on a profitable basis. We saw significant strengthening of the dollar in the latter part of March, and though this had a minimal impact on the first quarter, it will be important to keep this in mind as we think about the full-year outlook.

So looking forward, while industrywide dynamics may create <unk>, you know or business in the short term and there is significant uncertainty regarding the dynamics of the evolution of the pandemic, we ought to executing well, we remain well positioned and I'm excited about the potential of the company.

That I learned it over to David to walk you through our financial support this quarter and how we are thinking about our future David.

Thank you Giovanni Hello, everyone and thanks for joining who you're on your families are string serious unhealthy while you're operate virtually.

No. It's for your money mentioned I'm extremely pleased with your execution of or two during these on precedent times the benefits of or medicines in the strong commercial executioners over an exceptional performance in the first quarter.

Turning the slider, we hear it strong top where in performance and recorder with global <unk> double digits growing 13% versus per year on a perform a basis.

And so significant strengthening your per dollar and a lot of part of March.

This kind of minimal impact them first quarter will be important to keep in mind is we think about before your outlook.

David V. Elkins: Additionally, important to note, Dales was favorably impacted due to COVID-19 related stocking by approximately $500 million. Excluding the COVID-19 impact, underlying sales performance continued to be strong with 8% growth year over year. Now, let's turn to our key brand performance, starting with Eloklis on slide nine. Ellicott's had another strong quarter, growing 37% year over year with sales of $2.6 billion globally, largely driven by strong underlying demand.

Additionally, important to know.

Girls were favorite <unk> stocking by proximate $500 million.

Excluding the coveted night cream impact underlying sales performance continued to be strong per cent growth you're over here.

Now, it's current or two Grand performance, starting with a record from Florida.

I worked for a cut another strong quarter growing 37%. Your every year with sales of 2.6.

Overboard larger driven by strong underlying demand.

David V. Elkins: We also saw a significant favorable impact from channel and patient level stocking due to COVID-19 for approximately $350 million, which is expected to reverse over the remainder of the year. Excluding COVID-19's impact, sales growth in the quarter would have been 19%. As the COVID situation evolves, we'll continue to monitor the impact of customers and patients, including patient initiation. Although we expect some variability quarter to quarter due to the pandemic, we remain confident of Ellicott's growth network, where there's continual momentum to grow considering TRX share of 47% and new to brand share of approximately 57%. Looking forward, we continue to expect significant growth driven by Ellicott's increasingly strong position as the number one product in the expanding NOAC class. Now, turning to Adivo on slide 10.

We also saw significant favorable impact from trained on patient levels conquering <unk> reports from $350 million, which is expected to reverse over the remainder of the year.

Excluding coded 19, Okay sales grew up in a quarter would've been nice 2%.

That's a covert situation involved.

Can you to monitor the impact of customers in creation, including your patient parts.

Although we expect some very builder quarter to quarter to to appear in government remain confident of Alex's group at work, where there's continuing minimum to grow considering <unk>, 47% and new to brand share of approximately 57%.

Looking forward, we continue to expect significant growth driven by Alex is increasingly strong position number one product an experiment nor clients.

No turning to a fever on for like 10.

David V. Elkins: US demand trends are in line with our expectations. As previously communicated, demand is down in the low single digits sequentially. We continue to see stabilization of the second line IO eligibility pool of about one third, as well as strengthening of our position in the first line RCC market, which sets a good foundation for the potential future launch of Checkmate 9ER. Internationally, we saw strong execution continue with sales growth of 12% year over year. Abiba was minimally impacted by COVID-19 in the first quarter, with strong shares across all our indications. However, we are aware that COVID-19 has impacted patient access to oncology clinics and infusion centers, which could impact the volumes of infused products in the second quarter. We will continue to monitor these factors.

U.S. command trends are in line with the expectation has previously community theater demanded down in the low single picture sequentially <unk> of the second line I I would <unk> cool of about one third as well as strengthen your position in the first line or C.C. market, which separate good foundation for this.

For future Lawrence of tricked me nine your.

Internationally. So strong execution continued with sales group of 12 per cent your every year.

Eva was minimal your impacted by corporate 19 in the first quarter with strong shares across or indication.

However, we are aware that go good 19 within the patient actor from college you corner.

Centers, which could impact or volume of abuse products in the second quarter.

We will continue to monitor these factors.

David V. Elkins: Importantly, as we look forward, we believe that Devo is well positioned for a return to growth in 2021, with action dates and frontline long for 227 next week and N9LA later this year, as well as the upcoming opportunity for Checkmate 90 US. Now moving on to our inline multiple myeloma portfolio on 5.11. Revlimid and Pomelos continue to deliver strong double-digit growth of 14% and 29%, respectively, year over year. This growth is driven by increased share and treatment duration due to demand for Revlimid and Pomelos-based triplet therapy. The U.S. impact from COVID-19 was relatively minimal in the first quarter.

Importantly, as we look forward, we believe our beautiful as well positioned for returned to growth and 2021.

<unk> <unk> long for 227 next week and nine hour later this year as well as the upcoming opportunity for treatment 99.

No moving onto or inline multiple myeloma portfolio and 511 <unk>.

<unk> continued to deliver strong double digit growth, 14% and 29% respectively Euro per year.

This growth was driven by increase your treatment or they should do the demand for rebel married in Palm Springs Triple therapy.

U.S. impact from covert 19 was relatively minimal and the first quarter outside the U.S.. We estimate a favorable fired one started 550 million to 100 million dollar Crow good related stopping mainly for revlimid.

David V. Elkins: Outside the U.S., we estimate a favorable $50 million to $100 million COVID-related stocking, mainly for Revell. Due to the oral administration of Revlimid and Pomelos allowing patients to take the therapy at home and the potential for relapse in myeloma patients if treatment is stopped, we expect less of an impact due to treatment disruption related to the pandemic. We're continuing to monitor new patient starts as well as U.S. changes to buying patterns due to the FDA REMS program relaxation from 28-day to 56-day prescriptions. Because these products are sold through specialty pharmacies, we do not see the same level of stocking you would see with other chronic oral medications.

Due to the World administration of Revlimid N. car more functions character therapy at home and the potential for relax in my room acoustics of treatment, it's not <unk>.

We expect less of an impact your treatment disruption related to them it.

We're continuing them on or new patients dirt's as well as you are strangers to buying patterns duty you already runs program relaxation from 20 to 30 to 56 their scripts.

Because these products are sold through especially pharmacies do not see the same level stock and you would see with other chronic oral medications.

David V. Elkins: Now let's turn to the strength of the balance sheet and capital allocation on slide 12. We ended the quarter in a strong liquidity position with approximately $19 billion in cash and marketable securities, with our net debt coming down to $28 billion. We generated significant cash flow from operations in the first quarter of nearly $4 billion.

Now, let's turn to the strength of the boundary from Capitol occasions like 12.

We ended the quarter in a strong liquidity progression with approximately $19 billion in cash or marketable securities with her neck that coming down to 20 million.

We generate significant transfer from operations in the first quarter of nearly $4 billion.

David V. Elkins: The strength of our balance sheet will allow us to execute on our capital allocation priorities, which will continue to be our prioritization of deleveraging and achieving less than one and a half times debt to EBITDA ratio by the end of 2023, investing in future innovation through business development, and our continued commitment to our dividends. As previously stated, at the close of the Celgene transaction, we entered into a $7 billion ASR, of which 80% was retired quickly. The remaining 20% will be completed by the end of the second quarter. So we have a share repurchase authorization. Our priority for share repurchase is offsetting stock-based compensation.

Strength of our parents, who were allowed to execute on a couple of fixing priorities, which will continue to be our prioritization of be leveraging entered fever and less than one and a half times that you put the ratio by the end of 2020 correct.

Investing in future innovation through business development, and our continued commitment for different.

Previously stated that the close to the filtering transaction, we entered into a $7 billion, yeah, sorry agreement of which 50 per cent retired quickly.

Me 20 per cent will be completed by the end of the second quarter.

So we have a share repurchase authorization our priority for share repurchase it's all settings doctors compensation and having completed serious or we don't plan and near term share repurchase was in the current environment.

David V. Elkins: And having completed the ASR, we don't plan any near-term share repurchases in the current environment. Now, turning to guidance on slide 13. We are affirming our 2020 Adjusted EPS and updating our Revenue Range, MS&A, R&D, and OI&E line items. We now expect revenue to be between $40 billion and $42 billion, primarily driven by the currency swings I just described. We expect MSNA to be between $6.5 billion and $6.7 billion, and R&D to be between $9.2 billion and $9.4 billion, reflecting reduced activity due to COVID-19 combined with incremental operational efficiency. In OI&E, we expect to have reduced interest income driven by the lower interest rate.

No turning to garden from flight there too.

We were affirming or 2020, adjusted G.P.S. and updating a rubber revenue range <unk> orange.

Oh, I mean line items.

Now expect revenue to be between 40 billion in $42 billion, primarily driven by currency swings or just described.

<unk>, we expect and that's an area could be between 6.5 doing it 6.7, $30, an r. and d. to be between 9.2 billion and 9.4 billion, reflecting reduced activity through the code in 19 combined with incremental operational efficiency.

And Oh, I mean, we expect to have reduced interest income driven by the lower interest rates.

Now let me also provide you with some perspective on 2021.

David V. Elkins: Now, let me also provide you with some perspective on 2021. We are affirming our non-debt 2021 EPS based on positive momentum in the business and the assumptions we've made about the impact of COVID-19. As we mentioned in February, we don't plan to provide continual updates to our 2021 guidance. However, this quarter, in light of the exceptional circumstances associated with COVID-19, we believe it's important to confirm that our view of 2021 is intact. Our guidance reflects what we know today, and we will need to monitor how things evolve. With that in mind, let me provide you with some color on our guidance framework on slide 14. Our assumption is that the peak impact of COVID-19 crisis on businesses occurs in Q2 2020, with a return to a more stable business environment in Q3 and minimal impact from Q4 2020 onwards.

You're affirming or non got 2021, U.P.S. based on positive momentum into business and the assumptions we've made about the impact of corporate 19.

As we mentioned in February we don't plan to provide since you know updates for 2021 garden.

However, this quarter in order to the exceptional circumstances associated with covert 19.

Believe it's important to confirm that are view of 2021 is intact.

Regardless reflects what we know today and we will need the monitor how things evolve.

We got mine, we provide you with some color on our gardens framework on slide 14.

Or assumption is that the peak impact of Cougar 19, Craig's just run a business occurs in two 220 20.

What the return to a more stable business environment, and two three and minimal impact.

From two 420 20 onwards.

David V. Elkins: Key factors assumed in our guidance include products that saw significant advance buying at the end of Q1 will see their inventory work down during the rest of the year, mostly in Q2 and to a lesser extent in Q3 and Q4. A reduction in new brand prescriptions and physician-administered product demand during Q2, recovering in Q3, and fully recovered in Q4, and planning to resume all clinical activities by year end where local and country restrictions have been listed. These assumptions are based on holding FX and interest rates constant as of mid-April 2020. Our guidance does not include changes to macroeconomic factors that could affect not just our business but the entire industry. Of course, as we move forward, factors that are more industry-related and company-specific might have an impact on our current view, and we will need to incorporate that in our future analysis. These include the persistence of the strength of the U.S. dollar, recovery of demand post-Q2 2020, and the evolution of the macroeconomic environment.

Mm factors assume their gardens include.

Products that so significant events fine that's again, if you're one we'll see that inventory work down during the rest of the year, mostly into true into a lesser extent and three three to four.

Reduction in new brand prescription for surgery and Mr product of man during two to recover and two three and fully recovered into four.

And planning to resume all clinical activities by year end, where local and country restrictions have enlisted.

These assumptions are based off holding F.X. in the interest rates consonant ends of mid April 2020.

Or guidance did not include true just the macro economic factors that could affect not just start business with the entire industry.

Of course, as we move forward the factors that are more industry related companies slippery.

I have an impact on our current you and when we need to and we will need to incorporate the teacher analysis.

These include persistence with the strength of U.S. dollar recovery of demand post Q2, 2020 and evolution of macro economic environment.

David V. Elkins: Nevertheless, the fundamentals of the business remain very strong, and we remain disciplined with respect to our management of the P&L. Before we move on to Q&A, I want to reiterate how proud I am of our employees during the global crisis. Our strong first quarter results and our guidance demonstrate resiliency and diversification of our portfolio, and we continue to feel good about the long-term growth and financial flexibility of the business.

Nevertheless, the fundamental to the businessmen very strong and when you remained disciplined with respect for management or you know.

Before we move on to culinary and went to reiterate how proud or anything of our employees during the world crisis.

Are strong first quarter results in our guidance demonstrate resiliency and diversification of her portfolio and we continue to feel good about the long term growth in financial flexibility of the business.

Tim Power: I'll now turn it over to Tim and Giovanni to manage the Q&A. Thanks, David. Chloe, could we go to the first question, please? Absolutely. So the first question comes from Seamus Fernandez from Guggenheim. Please go ahead. Paul, thanks very much for the question. So one of the products that we've argued is being missed in cell gene acquisition is TC486.

Oh now turn it over to tune into your body to manage to today.

Thanks, David So we could we go to the first question. Please.

Yeah. So so the first question comes from Seamus for now this I'm going I'm just glad.

Oh, thanks very much for the question. So one of the products that that we've argued is being missed in the the Celgene acquisition is it's easy for eight six I was hoping.

Seamus Christopher Fernandez: I was hoping the team could talk a little bit about the commercial prospects, 4486, and kind of the durability of this asset as you think about it. And then, incremental to that, just wondering if you could update us on any data that would be coming outside of ASCO. I believe the EHA abstracts are hitting, frankly, on the same day as the late breakers will come out on either the 28th or the 29th. So just hoping to get an update on the rest of the pipeline. Thanks.

The team could talk a little bit about the commercial prospects.

4486, and kind of the durability of this asset as you as you think about it and then incremental to that.

Just wondering if you could update us on any data that would be coming outside it out to go I believe the E.H.K. abstracts or hitting frankly on the same day as the the Lake Breakers will come out on the either on the 20th and the 29, so just hoping to get an update on the rest of the the pipeline.

Giovanni Caforio: Thank you, Seamus. Thank you very much. This is Giovanni. So we're very pleased with the priority review designation for CC486. I'll ask Nadine to give you a perspective on the commercial opportunity there, and then Samit can follow up on your questions regarding data at ASCO and beyond.

Counting at E.H., okay. Thanks.

Thank you shameless. Thank you very much there's a giovanni so we're very pleased with the.

Designation for C.C. 486, Alaskan that D. and you to give you a perspective on the commercial opportunity there.

And and and some it can can follow up on your questions Forget me a date I'd ask them beyond thanks.

Right. Thanks for the question Shameless, we we remain very excited about Stacy 46, I think it's important to provide some some context. So we've yeah now it's very poor prognosis ski he even in the me died most setting where we look at five year survival eight sell around 50.

Nadeem Ahmed: Great. Thanks for the question, Seamus. We remain very excited about CC486. I think it's important to provide some context. So with AML, it's a very poor prognosis.

Nadeem Ahmed: Even in the newly diagnosed...

unknown: And even saying that most patients do have a complete response, but 80% of those patients will relapse within 18 months. So we're very excited about the fact that CC486 has delivered a 10 month survival benefit in that setting. So I think that's really important.

Being to 25%.

Depending on the age of patients.

And even saying that most patients do you have a complete response, but 80% of those patients will relapse within 18 months. So we're very excited about the fact that C.C. 46, Husky live that 10 months a Bible benefit.

Settings, I think that's really important and as we think about the opportunity. It's about 33000 patients overall and then if you think about the relapse rates seat at each stop to think about the the L.P. related to the disease, but the fact that without a 10 months vogl benefit with doubled the relapse free survival benefit I think when.

unknown: As we think about the opportunity, it's about 33,000.

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Nadeem Ahmed: which other drugs have tried, and we haven't seen survival benefits before in the maintenance setting, so I think from our perspective now having clarity on the PDUFA date, the launch team preparations are going very well indeed, and we remain very excited about the opportunity with CC486 and, in terms of durability, we feel very good about the position we have our intellectual property around CC486 so we're very excited about the opportunity for patients and for the business Maybe I'll turn it over to Samit now.

Big very excited about the commercial potential not only in terms of impacting those patients outcomes, but also the opportunity now just stopped <unk> a maintenance treatment paradigm in A.M.L., which other drugs have tried on we haven't seen survivor benefit the holding the maintenance on so I think from our perspective no.

<unk> the launch team preparation to gang very well indeed, you remain breaks thoughts about the opportunity to the C.C. 40, fakes and in terms of durability, we still very good about the the position we have our intellectual property around around to keep or do you think so we're very excited about the opportunity.

Keep a patient and for the business, it's easy 46, maybe I'll turn it over to some it now.

I was thinking a demon thank goodness and the question let me push say what we are looking at and then we looked at at school you've seen the titles that I've come out yeah, certainly looking forward to those very exciting data from nine L.A. and non smoking accounts and looking at them do a <unk>.

Samit Hirawat: Thank you Nadim, and thank you Seamus for the question. Let me first say what we are looking at when we look at ASCO; as you've seen the titles that have come out, we are certainly looking forward to the very exciting data from 9LA in non-small cell lung cancer, looking at up to year plus year of war and a limited amount of chemotherapy, along with an update with a three-year update for CHECKMATE 227. In addition to that, from a hematology perspective, more specifically, we're looking forward to the first presentation of the data from the CARMA trial for Ida cell and multiple myeloma, in addition to the Orva cell data update that will be provided. And very importantly, continuing with the multiple myeloma team, looking at the presentation of the data for CC480, the cell mod, which is going to be very, very important and exciting.

Limited amount of chemotherapy, along with an update a with a two year updates for checking into two seven in addition to that.

The perspective, more specifically you're looking forward to the first presentation of the data from the <unk>, So and multiple myeloma. In addition to the August sell data update that would be.

Very important continuing with the most of them I give up being looking at presentation of the data for C.P. for a zero the the celmod, which is going to be very very important and exciting.

Samit Hirawat: You asked about EHA; EHA will be more of our encore presentations following up from ASCO. In addition to that, we are certainly looking at the data sets in terms of the outpatient use of Lysocell as well at EHA. So these are going to be important data sets at ASCO, which we will obviously continue to talk about as we go forward and then follow up if there's anything more to say about EHA. Thank you.

You asked about <unk>, you to be more well encore presentations following up from high School. In addition to that you're certainly looking at the data sets in terms of the outpatient yourself life itself as well yeah. Okay. So these are going to be important then sets at high school, which <unk>.

All the secrets you have to talk about as we go forward and then follow up if there's anything more more to say about <unk>.

Thank you.

Thanks. Thanks, some play can we go to the next question. Please.

I certainly the next question comes from parents friends from Goldman Sachs.

Great. Thanks for taking the questions.

Maybe this is for Chris you, obviously have a number of ongoing your upcoming launches and just wondering how your adapting the commercial strategy here with the possibility at the current environment persists longer than maybe we do expect in are you confident that you can achieve your targets sales goals for a lot of these new product launches.

Samit Hirawat: Thanks. Thanks so much. Can we go to the next question?

Terence C. Flynn: Absolutely. The next question comes from Terence Flynn from Goldman Sachs. Great. Thanks for taking the questions. Maybe this is for Chris.

And follow up questions just on life's a cell B.L.A. submission was wondering if you can give any more specifics about the after your request. Thank you.

Terence C. Flynn: You obviously have a number of ongoing or upcoming launches, and I was just wondering how you're adapting the commercial strategy here with the possibility that the current environment will persist longer than maybe we'd expect. And are you confident that you can achieve your target sales goals for a lot of these new product launches? And then follow-up questions just on the LysaCell BLA submission. I was wondering if you could give any more specifics about the FDA request. Thank you.

Thank you Tyrants, let me just South Africa, Alaska, Chris to comment on on your question and the game and also then Salman can can can fill up a nice as hell, we're taking a very clear approach with with launches and.

Obviously.

The number one priority is to have the safety.

About employees over the healthcare profession, and also we don't we don't want to add disrupt sort of healthcare systems right now and so we've taken the position to really maximize early on Halloween military capabilities in terms of engaging with our customers in order to to respect.

Giovanni Caforio: Thank you, Terence. Let me just start. I'll ask Chris to comment on your question and Nadim's, and then Samit can follow up on Lysa's. They also apply differently to different brands because the launch of a new indication for an existing well-established brand is clearly a different strategy versus a totally new medicine. Chris and Nadim can give you a couple of examples of how those principles are applied to our launches and, obviously, the continued support of our portfolio.

The challenge isn't done day me, having said that white and we haven't global principles those principles apply differently had to different parts of the world and they also like different you from brands and because the loan shall then you indication for an existing when establish Brian's. This can be a different strategy versus a thought I mean, you medicine. So Christian.

Can give you a couple of examples how those principles and we got applying them to do I want to loan shows and obviously to continue with both of our before.

Yeah, So maybe I'll start tearing things for the question so as as Giovanni mention we made the decision a number of weeks ago too pool in personal in person engagement with customers that said, we have continued both on the medically commercial side to engage with customers remotely the good news.

Chris Boerner: Yeah, so maybe I'll start Terence. Thanks for the question. So, as Giovanni mentioned, we made the decision a number of weeks ago to pull in-person engagement with customers. That said, we have

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Chris Boerner: The good news is that BMS has made significant investments in remote engagement capabilities over the last few years, so the teams have a lot of experience, not just in the last couple of months, but for many years, in leveraging this technology to engage with customers. And as Giovanni mentioned, we've very much taken the point of view that every launch is going to be viewed independently, and we'll look at how we're going to engage with customers and how we're going to think about those launches, given the specifics. So, for example, you'll recall that when Zeposia was approved in late March, we decided to postpone that launch.

Is that the N.S. is made significant investment in remote engagement capabilities over the last few years. So so the teams have a lot of experience not just for the last couple of months, but for many years, you'll ever Jesus technology to engage with customers and as Giovanni mission, we very much shaking the point of view that every launches going to be viewed as.

Independently and we'll look at how we're going to engage a with customers in how we're going to think about those launches given the specific. So for example, you'll recall that one's opposed via was approved in late March we decided to postpone that long launch we did so because at the time to health care system was really just bracing for the impact of Kobe did with.

Chris Boerner: We did so because, at the time, the healthcare system was really just bracing for the impact of COVID, and within the MS community, specifically, we were starting to see.

And that's community, specifically, where we're starting to see a pretty big impact on their ability to operate through March for example was all about 25% decrease in new to brand scripts in in mass and we frankly didn't feel that the conditions were appropriate to introduce a new medicine without having our commercial and medical teams.

Chris Boerner: A pretty big impact on their ability to operate. Through March, for example, we saw about a 25% decrease in new-to-brand scripts in MS, and we frankly didn't feel that the conditions were appropriate to introduce a new medicine without having our commercial and medical teams be able to effectively engage with customers. That said, in recent weeks, we've begun to see the MS market begin to adapt to the current environment. Importantly, physicians are beginning to actively initiate new therapies. They've begun switching patients on therapy, and as a result, we plan to launch Zeposia on June 1st. In terms of preparations, the teams are very well prepared. We've hired a very experienced medical and commercial team that's been fully in place, frankly, before launch, and we've gotten very good feedback on the Zeposia profile, so we're very excited about making that opportunity available.

Able to effectively engaging house with customers that sad in recent weeks, we've begun to C.D.M.S. market begin to adapt to the current environment importantly positions are beginning to actively initiate new therapies it'd be on swishing pages on therapy and as a result, we plan to launch Deposi on June the first.

In terms of preparations the teams are very well prepared we hired a very experienced medical and commercial team that's been fully and quite frankly before launch and we've gotten very good feedback on it as opposed to your profile. So we're very excited about making that opportunity available. Obviously initially that launch what heavily index and this will be true.

Chris Boerner: Obviously, initially, that launch will heavily rely, and this will be true for first-line lung cancer as well, on remote engagements. Again, we have a lot of experience in leveraging that technology. Then, as conditions warrant, we'll be able to dial up in-person promotion, and ultimately, as we always do, we'll use a mix of both in-person and remote engagement to support those launches.

For personally lung cancer as well it will heavily index on remote engagements again, we have a lot of experience in leveraging that technology and then as conditions warrant, we'll be able to dialog in personal promotion ultimately as we always do we'll use a mix of both in person and remote engaged with to support those launches.

Chris Boerner: And we have a lot of confidence in the teams across the commercial organization.

We have a lot of confidence in the teams across the commercial organization in our ability to execute these launches did anything to add.

Nadeem Ahmed: Nadeem, anything to add?

Nadeem Ahmed: Sure. Thanks, Chris. I'll just say a couple of things. One, we're very excited about the opportunity to launch.

Sure all thanks, Chris I mean, I'll, just say a couple of things one.

We're very excited about the opportunity to launch <unk> medicines in the U.S. just this year and so the loans preparations again very very well with the team of course will continue to use on deep relationships with hematology.

Nadeem Ahmed: for first-in-class or best-in-class medicines in the U.S.

Nadeem Ahmed: and so the launch preparations are going very, very well with the team. Of course, we'll continue to use our deep relationships with humans

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Experts something <unk>, Oh, so I'll commercial infrastructure so.

Nadeem Ahmed: And we continue to hear good success stories about the ability to access physicians and customers in general through virtual engagement. So, we're very excited about the launches ahead of us. And, as Chris said, we've really pivoted to that digital environment, and we're finding we're gaining good access. So, very excited about those launches. And then I'll hand over to Samit for the other part of your question.

Clean rubbed his whole life. So I just L.C.C. 46, that's the potential for for a long season in the U.S. This yeah.

Just to give you some flavor walk Christmas, saying, we were able to break quickly we used the rabble as though pivot for the M.B.S. launch from a in life situation, which we thought about the beginning of the yet to a virtual launch and Oh, we continue to hey, good success stories about the ability to access of positions and customers in general to virtually.

Engagement. So so we're very excited about the launching the ahead of us and as Chris said, we're really pivoted Tibet digital environment I'm responding we're gaining good access so breaks talking about those long trees, and then I'll hand over the summer for the other part of your question.

Samit Hirawat: Thank you, and thanks, Terence, for the question. As it relates to LysaCell, as you know, we submitted the application with comprehensive data sets at the end of last year, and the FDA accepted the application for LysaCell and granted a priority review in February of this year. Now, it is typical for the FDA to request additional information as they continue their review process, and after the company supplied the information in response to several requests that the FDA had made, the FDA decided that the information they had received constitutes a major amendment, and that's why the Do-For-Date has been extended by three months to the 16th of November. We're obviously committed to ensuring this medicine is available to patients as soon as possible, and we continue Obviously, we're not going to comment on the specifics of our regulatory discussions, but let me just remind you that we remain very confident about the data for lysocells in these patients with large beef lymphoma, as it is an unmet medical need, and we're truly looking forward to the approval of this therapy towards the end of the year.

Thanking them and thanks to answer the question as it relates to a nice so as you know that'd be it's I've been to be application with comprehensive data sets and the end of last year and D.F.T. accepted the application for a nice it. So I'm gonna ended up prior to interview and <unk> This year.

No just typical for the kids request additional information that they continue their w. process and after the company supplied information response team. Several requests that'd be F.T. has made of D. has decided that the information. They have received constitute a major and then that's why we're due for date has been extended by team wants to the 16.

I remember now.

<unk>, obviously committed to ensuring just medicine is available to patients as soon as possible and we continue to me does she have you had milestones obviously, we're not going to comment on that specific supply regulatory discussions, but let me just in mind that we'd I mean very confident about the data for a nice itself for these patients, but not it'd be so lymphoma.

As it isn't and up medical need and are we looking forward to the approval because quite a few towards the end here.

Samit Hirawat: Thank you. Thanks, fella. Chloe, could we go?

Thank you.

Tim Power: Chloe, could we go to the next question, please?

Yeah. He goes to the next question he.

I certainly the next question comes from just from each some bank of America.

Geoff Meacham: Absolutely. The next question comes from Geoff Meacham from Bank of America. Yeah, thanks so much for the questions. I've just got a couple.

Yeah I think.

I just got a couple the follow up for for gave it if the environment normalize this year mace.

Geoff Meacham: As a follow-up for David, if the environment normalizes this year...

Geoff Meacham: At a lower run rate for some of your launches, does this affect how you think about 2021 in terms of revenue or cash flow? And are there opportunities for CNBs to be equalized on an accelerated basis? And then Giovanni, the big picture on the beauty front. We've talked about deals still being in focus, even as, I'm just curious whether the COVID-19 environment alters this view, either their priorities or perhaps the size and scope.

But a lower runrate for Sunday or.

Since it's just affect how you think about.

21 in terms of revenue or cash flow.

Opportunities for Sam Houston equal on us on accelerant basis.

Giovanni did catch on on on the beauty from you talked about you'll still being focus even has.

Oh it integrates <unk> was curious whether the covert 19 environment offers this view other priorities are perhaps the size and scope.

Geoff Meacham: Thank you.

Thank you.

Mm.

David V. Elkins: Thank you, Geoff. Let me ask David to start and give you a perspective on 2020 and 2021. It's really what has been reflected in our guidance, and I'll get to your second question immediately afterward.

Thank you dress, let me ask let me ask David to stars can give you a perspective on.

On 2020, and 21 needs really what it's being reflected you know guidance in a a good to your second question me after.

David V. Elkins: Yeah, so thank you for the question. You know, particularly on guidance, as we're thinking about it, as we said, is, you know, right now, we think the inventory buildup that came through is going to release out mainly in Q2 and for the remainder of the year, as far as, you know, what we're watching closely as the new patient starts and our anticipation that that recovers in Q3, and we're back to normal in Q4, and as well as the infusion centers and the volumes returning to normal. And, you know, that would continue into 2021. What I would say is that the underlying performance of the business is very strong in the first quarter. And, you know, as you heard about with the product launches, our confidence in those four product launches are coming this year, as well as the product launches next year.

Yeah. Thank you for the question and you know particular guidance as we're thinking about it as we said is no right now we think the imagery built up clicking through it was kind of really so mainly two two and for the remainder here as far as you know we're watching closely with some new patient starts and learn suspicion that recovers into three more <unk>.

The normal and two four and and as well into confusion centres and the volume's returning a normal.

And you know that would continue into 2021, what I would say is that the underlying performance of the business is is very strong and the first quarter.

And you know where it's because you heard about what the product launches or confidence in those four product launches are coming up this year as well as the product launches next year that gives us the confidence in you know reiterating or or gardens for both this year and next year, but we're gonna keep a very close I.

David V. Elkins: That gives us confidence in, you know, reiterating our guidance for both this year and next year, but we're going to keep a very close eye on the macroeconomic factors that could wind up impacting the entire industry. You know, as I talked about in my remarks, as far as synergies are concerned, we continually review those synergies, both internally and with our board. We are really pleased with the progress we've been making on the synergy front, and, you know, the progress with our third-party vendors has gone very well, and as far as getting the organization in place, the vast majority of our placements of the organization are done, and as far as site selection is concerned, you know, bringing our sites together, that's moving along as planned, as well. So, you know, we remain confident in delivering the synergy targets that we set. Thank you, David.

On the macro economic factors that could wind up in fact, the entire industry.

I talked about in my remarks as far as the synergies you know when continuing review go synergies both internally as well so with our board. We were really pleased with the progress we've been making on this energy front and you know progress with a third party vendors and so on very very well and as far as.

Getting the organization in place the vast majority for placements of the organization are done and as far as site selection is concerned you know, bringing our sites together on that's moving along the lines plans as well. So you don't remain confident and you know delivering the finished market for it we have thank you.

So just and and then going back to to your question, Jeff. So let me just say first of all we are we are they we're very happy with the problem is we've made with Dean took a national company and at the same time the strength of execution in the company. So.

Giovanni Caforio: So going back to your question, Geoff, let me just say, first of all, we are very happy with the progress we've made with the integration of the company and, at the same time, the strength of execution in the company. So on the one hand, our business continues to perform really well. As you've seen, we've made great progress with the pipeline against all key value drivers. We're executing well; we've made progress. I would say we are progressing really well with synergies as well.

Inside our business continues to perform really well as you've seen we've made great progress with the pipeline against old old key value that Iverson, we're actually getting when we've made progress I would say, we we are over that she needed when with Seanergy sense, well and we have tremendous flexibility from a piano.

Giovanni Caforio: And we have tremendous flexibility from a P&L perspective and from a financial perspective. So going forward, we will continue to be very disciplined in terms of how we think about resource allocation and expenses given the evolutions related to the COVID pandemic. Now, given our strong position, as David mentioned earlier, we've not really changed our capital allocation strategy. Business development remains the central pillar of our strategy. We are very focused on continuing to bring new assets and innovation into the company. I expect that to continue to be the case, and it's very possible, in fact, that there will be more opportunities available to us going forward. And we are definitely focused on business development as we've always been.

Aspect, even though I'm from a financial suppose tactics. So going forward, we will continue to be very disciplined in terms of how we think about we used our site location and and a expenses even evolution is related to that Kobe Fandetti now given our strong position as David mentioned <unk>.

Khalidi changed I will copy the location strategy <unk> dealer hold our strategy, we have any focused on continuing to bring you offsets any innovation into the company I expect that to continue to be the case any genetic possible in fact that that are more opportunities available to us going for work.

And we definitely focused on business you got them because we've always be so thank you.

Giovanni Caforio: Giovanni and Chloe, we're ready for the next one. Absolutely. The next question comes from Chris Schopp from J.P. Morgan. Great. Thanks so much for the questions. Just two for me.

Contextually Kellie, we're ready for the next month.

Axelson next question comes from Chris Shopped from J.P. Morgan.

Great. Thanks, so much for the questions just to for me. The first one in light of the nine yards study you talk about the R.C.C. market and the opportunity you see for Eva Your voice versus I.O.T.K.I. combinations over time, and how you see <unk> Bristol positioning these two different frontline offerings.

Chris Schott: The first one, in light of the 9ER study, can you talk about the RCC market and the opportunity you see for Updivo-Urvoy versus IO-TKI combinations over time? And how do you see Bristol positioning these two different frontline offerings they're going to have as you think about how you're going to position them relative to one another? My second question was on COVID and drug pricing. I think you mentioned some of these kind of macroeconomic factors. But when you think about high unemployment, as well as growing budget deficits from government payers, how do you see that flowing through as we think about net pricing looking out later this year and into 2021? Is that the core of the question? Do you think it's likely that we're going to see some sort of incremental impact on pricing from what's occurring with COVID right now? Thank you so much.

How fast you think about how you gonna positioned them relative to one another.

My second question was on what's uncovered in drug twice, saying I I think you mention somebody's gonna macro economic factors, but when you think about high unemployment. This was growing budget deficits from government pairs.

How do you see that flowing through was or think about net pricing looking out later this year and into 2021.

Core of the question you think it's likely that we're going to see some sort of incremental impact to pricing from from from what's occurring with coded right now. Thank you so much.

Giovanni Caforio: Thank you, Chris. Let me start. I'll give you my perspective on pricing, and then I'll ask Chris to comment on 9ER and RCC.

Thank you <unk>, let me, let me start to I'll give you my perspective on pricing and and then the last Chris to comment on on 90 hour and a and R.C.C. It's exciting there. So first of all I think a little first of all I would say, Chris the issue of drug pricing is one where.

Giovanni Caforio: It's exciting there. So first of all, I think a lot of, first of all, I would say, Chris, the issue of drug pricing is one where we've been in dialogue now for a period of time. And we, as an industry and as a company, continue to think that there is a real need for us to be strategic and think about reforming some of the elements of the pricing system in the U.S. that are creating affordability issues for patients. As you know, we believe there is a real opportunity through rebate reform and other measures that are market-based to address the issue of drug pricing in terms of patient affordability, which is the real Now, with respect to your question, first, you know, it's early days, and it is early to say, and it's difficult to speculate on the future.

We'd been in dialogue now.

For for a period of time and we'd it's an industry and as a company continue to think that he's you'll need to be strategic and think about reforming some of the elements of the pricing system in the U.S. that creating a for the B.D. issues for patient say is is you know we we <unk>.

I have a yellow or two need food, we basically for main either.

Measures that our market based web address the issue of different pricing in terms of patient afford that beating which is living really should now with respect to your question. <unk>. You know, it's early days entities, Italy to say, it's difficult to speculate on the future of course the focus.

Giovanni Caforio: Of course, the focus of many, and I think that was at the center of your question, is what happens in an environment where unemployment is higher and has a significant impact on commercial markets. So one way to think about it is if you look at our business, where 60% of our business is in the U.S., in the U.S., so of that 60%, about 25% of our business is in commercial markets.

Oh Man you and I think that was at the center of your question is what happens in an environment, where unemployment is high year and a significant inbox to the commercial market. So one way to think about it. If you. If you look at it I wouldn't business where 65.

<unk> proximately in the U.S. in the U.S. It shows that open that she could see they're saying about 25 per cent of our businesses in the commercial space and when you look at the dynamics than me play out in the commercial space I think a lot depends on.

Giovanni Caforio: When you look at the dynamics that may play out in the commercial space, I think a lot depends on what happens to patients that may be unemployed and potentially lose coverage. Some of those patients will move to a spouse's insurance plan. Some of those patients may take up COBRA. Obviously, any strategy or policy that makes that even more affordable would be beneficial for patients. Some of those patients will be eligible for Medicare if they're over 65. There may be some shift to government programs like the exchanges or Medicaid, but hopefully, no patient or very few patients will lose coverage. So these are all of the dynamics that we're going to be working through. And, of course, a lot depends on the shape of the recovery and how long unemployment lasts. But I think these are sort of the macro factors that we'll be looking at together. So with that, I'll ask Chris to give you his perspective on the FTC market and the excitement behind it.

And at what happens two patients that maybe unemployed and potentially news coverage. So some of those patients will move to a spouse's insurance bland simultaneous patients may take up Cobra.

And obviously any strategy on policy than me snack more affordable wouldn't be even more for that but wouldn't be beneficial for patients. Some of those patients will be eligible for Medicare if they over 65, there may be some shifts to go from Goldman programs like the exchanges or or.

Or Medicaid and and and hopefully no patient or very few patients is coverage. So these out a little bit dynamics. They were gonna be working through and and of course, a lot depends on the shape of dirty called <unk>, how long unemployment last but I I think these are sort of the Mac for factors that we'll be looking at.

Together, so we that <unk>, Alaska acoustic <unk>, he's perspective about that yeah. She market in the excitement we nine or.

Chris Boerner: Yeah, thanks for the question, Chris. We're very excited about the data that we saw with Dyeing ER. Maybe in answering your question, I'll start with just kind of an update on where we are with Updiva plus Urovoi today in first line renal. If you go back a year, one of the things that we said when we first started to see the IOTKI data was that we anticipated that Updiva plus Urovoi would remain a standard of care in first line. And that's precisely what happened.

Yeah things for the question you press, we're very excited about the data that we saw with 90 or maybe in answering your questions. We'll start with just kind of an update on where we are with a beautiful as your avoid your day in the first line Reno. If you go back a year or one of the that we said when we first started to C.D.I.H.T.K.I. data was that we anticipate.

<unk> plus your avoid would remain a standard of care and first line and that's precisely what's happened and we think that's been driven primarily by the impressive long term, but it is that you've seen without debo plus year old boy. We just saw the 42 month was update add ask code you you data west was about 50.

Chris Boerner: And we think that's been driven primarily by the impressive long-term benefits that you see with Updiva plus Urovoi. We just saw the 42-month OS update at ASCO GU. That OS was about 56% in the ITT population, and that's driven the continued strong performance of Updiva plus Urovoi in first line. Market share right now is between 30 and 35% overall. It's on the upper end of that range when you look at the labeled indications that we have in intermediate and poor. We do get some non-promoted use in the favorable population, which is off-label for us, of about 15% Updiva plus Urovoi use there. And we've also seen that the majority of the use that existing IO plus TKI therapies have gotten in first-line renal has largely been at the expense of TKI monotherapy.

Six per cent in the I.T.T. population and that's driven continued strong performance of up Eagle plus your or your first line market share right now is between 30 and 35% overall on the upper end of that range. When you look at the labeled indication that we have an intermediate and poor we do get some non promoting use.

And the favorable population, which is off label for us of about 15% do you go plus you're overweight use there and we've also seen that the majority of the use that existing I.O. plus T.K.I. therapies have gotten to the first line renal has largely the expense of T.K.I. motto therapy.

Chris Boerner: So Updiva plus Urovoi has held up really well, and in fact, we've seen a bit of an uptick in sales of Updiva plus Urovoi over the last number of months. 9ER, very exciting data. We're very happy to see both the OS and the PSS data that we saw there. Also, very encouraged by the safety profile for 9ER. In terms of how we're thinking about positioning it, still very early days, and we're working through the data. But we think these data compete very well against existing IO TKI therapy.

So I'll be able plus you're all the way it was held up really well and in fact, we've seen a bit of an uptick enough people plus you're a boy over the last number of months 90 are very exciting data, we're very happy to see both the L.S. in the P.L.S. data that we saw there also very encouraged by the safety profile for nine E.R. in terms of how we're thinking about positioning yet.

Spilled very early days and we're working through the data, but we think these data can be very well against the exists D.I.O.T.K.I. therapies. As a result, we think there's an opportunity to drive share from existing I. If you get here <unk>.

Chris Boerner: We also think that there's an opportunity to drive share from TKI monotherapy in spite

We also think that there's an opportunity to drive share from T.K.I. monotherapy in spite of advances in or sign Reno T.I. Monotherapies still about 20 to 25 per cent of share mostly in the favorable population.

Chris Boerner: [inaudible] Importantly, the last thing I would say is that once approved, 9ER really does give us the opportunity to offer patients multiple IO modalities. We'll have the opportunity, and we'll be the only company, frankly, to have dual IO, but also what we believe will be a best in class IO TKI offering.

And with respect to Favorables, we hate there's an opportunity there for us as well since 90, our crossroads status included that favorable popular they shouldn't be now once approved will have access to that population promotionally.

Important will be laughing I would say is that once approved 90 are really does give us the opportunity to offer patients multiple I own blood allergies here, we'll have opera <unk> will be the only company frankly to have dual I.P.O., but also what we believe will be a best in class I.O.T.K.I. offering so very excited about.

Chris Boerner: I'm very excited about the opportunity that 9ER affords us to help patients and provide another modality to those patients. And I think that there's a great opportunity.

The opportunity that 90, our hordes as to how patients and provide another modality to those patients and I think that there's a nice opportunity.

Chris Boerner: Thanks, Chris. Chloe, could we go to the next question, please? Certainly. The next question comes from Andrew Baum from Citi.

Okay. Thanks, [laughter], probably could be good for the next question.

[noise] certainly next question comes from and She'll Bahnsen City.

Thank you <unk> in terms of the 10 thing nine at H., a a basket what is the follow up with that they took the boats L.S. on the P.S.S. My question is awful addition is getting to come after that presentation, and we think that strategy for <unk>.

Andrew Baum: Thank you. Some questions for Samit, please. In terms of the pending 9LA data at ASCO, what is the follow-up of that data for both OS and for PFS? My question is, after

Andrew Baum: Our physician is going to come out of that presentation and rethink their strategy for first-line non-small cell lung cancer on the back of that data. Is there enough follow-up there? Second, in terms of the 9ER trial, could you talk to Carbazantinib? I remember that when you ran phase two, there was a question about toxicity, and I can remember you used a lower dose.

Small so long I'm on the back of that data is there enough follow up that second in times of the 90 odd trial could you talk to <unk> I remember the that when you ran the phase two there was a question about toxicity and I contribute to know does so given it's a much more promiscuous T.T. I should we assume that.

Andrew Baum: So

Andrew Baum: or Comparable Tops Profile. Anything you could share that would be interesting.

Favorable well compatible tops profile anything to shut that'd be interesting and then finally TIGIT sport ticket roche's pushing forward it very aggressively with that <unk> <unk> <unk> hitting is interested in active with that you'll program seems not true and probably much is that a function of.

Andrew Baum: And then finally, on Tidget or Ticket, Roche is pushing forward very aggressively with their Tidget antagonist. Merck clearly is interested and active in theirs. Your program seems not to have been very much. Is that a function of resource allocation, or is it a function?

<unk> allocation or is it a function of what you're saying with this particular molecule.

Giovanni Caforio: And this is a function of what you are seeing with this particular molecule. Thank you, Andrew. So, Samit, I believe all three.

Thank you.

Thank you Andreas so somebody that's been equals three elements of the the question something for you.

Samit Hirawat: Thank you, Andrew. As always, very thoughtful questions and certainly thought-provoking. From a 9LA perspective, certainly we're looking forward to the first presentation of the data at ASCO, although virtually, but it is certainly going to be very meaningful. As you recall, we had finished enrollment towards the beginning of last year. So at the first readout of the data, the interim analysis, the follow-up is short. What we will be able to share is follow-on data from that perspective. It's very important, I think, to realize from the 9LA perspective, a few questions that we will be looking towards the data to answer. One is, as we continue to follow on and as we continue to follow up, what happens to that OS curve?

Thank you Andrew always as always though very popular questions and certainly.

Thought provoking come on nine though they perspective, certainly we're looking forward to the first presentation of the data asset pool, all the ritually, but certainly are you going to be very meaningful as you did cause we had finished in goldman towards the beginning of thought last year. So the first read out of the data the interim analysis.

The short we will be able to share is follow on data from that perspective, it's very important I think to realize.

I know they perspective, a few things that questions that'd be we'll be looking towards the data to the answer one is as as we continue to follow on and then you can hear the follow up what happens to that Oh, it's curved does it start this lacking number one number two what happens to the beginning part of the <unk>.

Samit Hirawat: Does it start to flatten out, number one? Number two, what happens to that beginning part of the curve that we saw in Checkmate 227, where we have the early progressors and how does a limited amount of chemotherapy impact that? I think those are the very important answers that we'll be looking for as we look towards the presentation of the 9LA data. We remain excited.

He saw check made to do seven we have the early progressors them, how a limited amount of chemotherapy can act that I think those are the the very important answer the you'd be looking for I have you looked towards the presentation of the <unk>. We demand excited I think both of them how can be considered together, but to do seven data and the <unk>.

Samit Hirawat: I think both of them have to be considered together, the 227 data and the 9LA data in the overall management of a patient as we look towards non-sponsored lung cancer management as we go forward. So I think that dual IO inhibition becomes very important along with that shortened duration of chemotherapy for some patients who require it. I will obviously ask towards the end when I finish that question to Chris also to comment from a commercial perspective on what that really means. On the 9ER side, as you mentioned, carbametics was used at a dose of 40 milligrams. And certainly that is going to be important in terms of managing the safety profile, as we've already said.

Data and we're all management a patient.

Look towards non smoking and lung cancer management as people forward, So I think that.

Do you. In addition becomes very important along the best short duration of chemotherapy for some patients required.

I will obviously afterwards, the and when I finish to Chris also the common mile from commercial perspective.

Oh, the 90 outside.

As you mentioned, probably medical use of that those up 40 mother guns and certain need that is going to be important in terms of a management Oh five to 50 profiler you've already said the overall what we have seen is generally quite manageable safety profile as Chris also spoke about.

Samit Hirawat: Overall, what we have seen is a generally quite manageable safety profile, and as Chris also spoke about, this provides an opportunity for further use of Obdivo in all the risk categories in combination with COVID-19. So certainly, very exciting news where the trial has met all three endpoints, the major endpoints that we look at from an overall survival benefit, as well as looking at PFS and risk constraints, in addition to a very well-managed safety profile. And I'll finish off on the TGIT, and then I'll pass it on to Chris to comment further on both 9LA as well as 9ER.

This provides an opportunity for further use of of evil and all the risk categories in combination with <unk>. So this time, so certainly very exciting news, where they've tried was met all three and points majored in queens it'd be look at from an overall survival benefit as well as and looking at the.

And this <unk> in addition to a value of mine safety profile and I'll finish off on the digit and then does lots of Chris still going further on both of mine I live.

Samit Hirawat: On the TGIT perspective, we are looking forward to seeing the data that Arosh will be presenting. Certainly, a very complex mechanism, as you very well know. We have our molecule, which is in phase one. We continue to evaluate the safety and the overall dose profile for that agent. And certainly, there's no data to be shared yet, but we will certainly learn from what Arosh is going to present.

We are on the ticket perspective, you're looking forward to see the data, but a little shouldn't be presenting certainly a very complex mechanism you very well no. We have our molecule witches and saves one we continue to be valued but safety and and the overall both profile <unk> agent then certainly there's no data to be shared yet but.

Learn from watch where she's going to present, and then see if I'm getting to manage differently, Chris <unk> I think.

Samit Hirawat: Sure, I think that Samit hit on most of the points around 9LA. What I would say from a commercial standpoint is obviously we've had a lot of discussions with positions over the last few months about 227 and 9LA, and it's important what Samit said about those positions, and we really do think that 227 and 9LA really need to be thought about together. 227, you'll recall that what we showed was about 50% of responders were still responding at two years, and we saw this nice flattening of the OS curve. You'll see how that data matures at ASCO in a few weeks, but then the way companies are thinking about 9LA is very much as complementary to 227 in that they offer the benefit of Opdivo plus Urovoid to patients who don't need chemotherapy, that's 2 And I think Samit hit on some of the key things that you'll want to pay attention to when that data are presented at ASCO in a few weeks. Two other things that I would just keep in mind with respect to Opdivo plus Urovoid and Lung.

Sure I I think that summit sit on most of the points around nine L.A., what I would say from a commercial standpoint is obviously, we've had a lot of discussions with positions over the last few months about to do seven and nine L.A. and it's important what sign that said that position and we really do think that you do seven and nine L.A. really need to be thought about together.

227, you'll recall that will we showed was about 50 per cent of responder. If we're still responding a two years and we saw this nice flattening of the O.S. curved you'll see how that data that shorter than ASKO and in a few weeks, but then the way positions are thinking about nine L.A. is very much as complementary.

To to to seven in that they offer the benefit of upheaval plus your avoid a patients who don't eat chemotherapy. That's two seven and for those patients who potentially do eat chemotherapy and that's where nine L.A. came and it comes into play kinetic sounding hit on some of the things that you want to pay attention to win that data are presented at at.

Nasco that few weeks to other things that I would just keep in mind with respect up you go plus you're away long first are about half of the lung cancer treaters have used up <unk> either in melanoma <unk>. So they're familiar with the benefit that we see with that regimen there in those positions account for.

Chris Boerner: About half of the lung cancer treaters have used Opdivo plus Urovoi either in melanoma or renal, so they're familiar with the benefits.

Chris Boerner: Thank you all so much for joining us today. We're really looking forward to Padupha Day for 227 next week. Thank you, Chris.

About two thirds of total lung cancer patients and then the second thing not not a trivial thing is that we had a very experienced team where their track record of being able to establish opdivo plus Uruguay at a standard of Kerry in both of the tumors in which we've been approved with that regimen and they buried.

Tim Anderson: Thanks, Chris. Chloe, could we get to the next one, please? Certainly. The next question comes from Tim Anderson of Wolf Research. Please go ahead. Thank you.

Credibly excited and prepared to to launch a beetle plus you're waiting for a sign lung cancer. We're really looking forward to that they do per day per to do something next week.

Thank you Chris.

Thanks, click slowly because we get to the next one please.

<unk> really the next question comes from 10 Anderson.

Tim Anderson: A couple of questions, please. Quite a few of you... Bristol narrowed its footprint in emerging markets intentionally to kind of focus on, I think what it felt were geographies where it had more scale and presence. But with Celgene folded in, you're a much bigger organization, and it kind of makes me wonder what the plan is for emerging markets going forward. I don't even see emerging markets or China, you know, mentioned in the press release or in the slide deck. But as we've seen across the industry, geographies like China are very important, especially in the area of oncology. So it makes me wonder if there's kind of an untapped revenue stream here. And what's the solution if you think there is indeed a problem that you don't have a big enough footprint now given the size of the company? The second question is on lag three. I understand that you have pivotal LAG-3 plus Optivo combination data coming up around year-end, and Firstline Melanoma. It's a program that doesn't seem to get talked about very much, and investor expectations are low. My question is, should those expectations be low? Do you view this as a high-risk program?

I'm all for research. Please go ahead.

Thank you a couple of questions. Please.

Quite a few number.

Crystal narrowed it's footprint in emerging markets intentionally to kind of focus on I think what it felt was geography is where it had more scale and presents.

What was celgene folded down you're a much bigger organization.

And that kind of makes me wonder what's the plan is with emerging markets going forward I don't even see emerging markets or China.

And in the press release round, the slide deck, but as we've seen across industry geography is like China are very important, especially in an area of on college you. What makes me wonder if there's kind of an untapped revenue stream here and what's the solution. If you think there is indeed, a problem that you don't have a big enough footprint now.

And the size of the company.

Second question is on lag three if I understand it you have pivotal lag three plus optivo combination data coming up around the year round.

And first line melanoma.

That's a program that doesn't seem to get talked about very much investor expectations are low.

Question is should those expectations be low D.V. this as a high risk program.

Giovanni Caforio: Thank you, Tim. Let me just answer your first question and then I'll ask Samit to give you his perspective on the ongoing BlackTree program. I think your point is really important. It is a very good question.

Thank you Tim I mean, just onto your first question and then Alaska I'll ask some interest to give you. These perspective on on the on going Black Clean program I think your your your point is is really important is it is a very good question you are right that given our focus on.

Giovanni Caforio: You are right that given our focus on oncology and all of the work that we have done over the last few years, we have been focused primarily on, I would say, the developed world. I must say we have a meaningful presence in developing countries, and when we look at the development of our oncology business in particular, we have had significant success outside of the U.S. and Europe in major markets, including Central and Eastern Europe and some of the key markets in Latin America, and, as you know, recently with the approval of people in China. So, it is also accurate that now we have a broader portfolio and more opportunities to establish a larger presence outside of the Tier 1 top markets, and I'm actually really confident we have the right capabilities there and we have a strong base to continue to invest internationally. There is a real opportunity, but there is also already a presence of the BMS portfolio that has been successful there. So, we'll continue to invest across different geographies, and there is an opportunity with a broader portfolio to have an even broader approach with respect to the footprint.

On a phone call, a g. and and all of the work that we haven't done over the last a few years, we have being focused.

Financially on I would say the developed world I must say, we have a meaningful presents a in developing counted as and when we've seen.

When we look at the settlement of our of our own color <unk> business in particular in 30, or we had a had significance excess actually outside of the U.S., and and and Europe, and major markets, including central and Eastern Europe, and and some of the key markets.

And that it can as you know recently with the approval of Oh debugging Nah in China. So it is well so occupants of that now we have a boulder portfolio.

And multiple Tunis to establish a larger presence outside of the <unk> thought my cats and I'm I'm actually it would be confident we have but that I've capabilities, there and we have a strong base to continue to invest internationally. These days over your little opportunity, but he's also hold radio.

Presence of it'd be a mess up or fold here that has been successful there. So we'll continue to invest.

You know I cross different you all their fees and that he's an opportunity with unfolding before you to have to have an even bolder approach with respect to the footprint.

Samit Hirawat: Samit

Samit Hirawat: Thank you, Giovanni. I'll take on the LAG-3 question. So I think, first of all, a lot has happened in terms of the drug development part for patients with melanoma, and certainly DMS has played a big role in getting the IO therapies there with both Abdigo and Yervoy. LAG-3 is a new mechanism that we are excited about from the early phase one data we have seen, and also from the biomarker data perspective, looking at T-cell exhaustion and how From that perspective, this is going to be a very important study. The trial is currently enrolling patients, and we're certainly seeing from the investigators' perspective that they remain excited, and they continue to enroll patients in the trial. It is on track. From an enrollment perspective, we continue to collect data. We're looking forward to the readout towards the end of the year. In parallel, we continue to plan life-cycle management studies in terms of looking at additional indications that you will hear about as we roll them out towards the end of the year and early next year as well.

<unk>.

Thank you <unk> they call them back. So you question, So I think.

<unk> a lot as happened in terms of drug development Park, and patience with melanoma, certainly D.M. as pay to be unless he played a big role in getting <unk>, both a beagle and your boy.

Let's see the new mechanism that we get excited about from the early page one data we have seen and also from the by my could be a prospective looking at the pizza and exhaustion and how to get the immune system going again from that perspective. This is going to be a very important study. The tried is currently enrolling in this certainly seeing from.

The investigators perspective, the main excited and they continue to enroll gradations in the trial. It is on track from an enrollment perspectives be continuing to collect the data been looking towards to read out towards the end of the year and in parallel would be continued to plan a life segmented need studies in terms of looking additional indications.

That you will hear about as we are told him out towards the end of the early next year it as well.

Yeah.

Samit Hirawat: Can we go to the next question, please, Chloe? Certainly. The next question comes from Matt Fitz from William Blair. Lauren, thanks for answering my questions.

Goes to the next one k. slowly.

<unk>.

Next question comes from Matt sets from William Blake.

[noise] or in the expert they met questions first given the current environment and potential trouble accessing infusion clinics. They reasoned to accelerate the element of her that'd be 10, if they're going to have another trials and going on there since 2018 looking at that and second way for the tick too.

Matt Fitz: First, given the current environment and potential trouble accessing infusion clinics, is there any reason to accelerate the development of a subcutaneous nivolumab? I know the trials have been going on there since 2018, so I'm looking at that. And secondly, for the TIK2 small molecule, I just want to confirm that the psoriasis trials are on track to complete by mid-year or this summer, and all the physician assessments can be completed. And then there's a lot of formulation work ongoing, according to clinicaltrials.gov, and just wondering if any of that will impact potential filings in the near-term, if the trials are completed.

Okay I'm, just looking for a little psoriasis trial that are on track to complete.

Oh this summer and all the physician assessments can can be completed and then.

But a lot of <unk> letter formulation work on going according to clinical trials, but I'm just wondering if any of our impact.

Since filing within no no cable for tells us to so cool.

Giovanni Caforio: Thank you, Matt. So, Samit, I think there are two questions on SAP Q of Divo and then the status of the T2 program.

Thank you Matt so some it I think there's there's two questions on Sept Q. of D., one day and the status if the T. to program.

Samit Hirawat: Absolutely. Thank you. So the only thing I can say about SubQ Nivo is that we are currently evaluating it, and I think acceleration will depend on the outcomes of the first phase one studies as we look towards dosing and tolerability and safety, which should be available sometime soon. And then, based on that, we will continue to progress further, looking into further development and bringing it to the patient. For your second question around TIC-2, as you recall, the Phase 2 data were certainly very, very promising. Phase 3 trials, both 046 and 047, have completed enrollment. So at this time, we are looking at follow-up of these patients, collecting the data, and cleaning activities so that we can approach the database block. There is no reason to believe that there will be any delays. We're looking towards the end of the year for readout of the first study, 046, and first follow-up next year for 047 for the psoriasis program. So those two will be updates for TIC-2 and subcuneo. Back to you, Tim.

Absolutely. Thank you. So the only thing I can say about it's up to new go that'd be are currently evaluating that it is ongoing I think that situation will depend on the outcomes on before its food. One study that'd be look to words and building and the Thunder ability and safety it should be available sometime soon and then.

Based on that bill compared to progress further looking into look or the development and bringing it to the patients through your second question take too as you recall.

The place to data were certainly very very promising basically tried both 046 or seven completed and Goldman said. This time good looking at a follow up obese patients collection of the data and cleaning activities, so that'd be fun.

The database Locke, there's no reason to believe that there won't be any delays are we looking towards the end of the year for lead out of the first study over six and four school next year 4047 for this program. So those those two idea dates for took two ends up getting back to your pen.

Steve Scala: Thanks so much. And I know we're starting to run close to the end of our normal time, but I think it's maybe time to squeeze in two more questions. Chloe, could we go to the next one? Absolutely. The next question comes from Steve Scala from Cohen. Please go ahead.

Thanks, and I know, we're starting to run close to the end.

<unk> I think maybe tend to squeeze into more cautious totally could we go for the next one.

Absolutely.

Question comes from Steve <unk>. Please go ahead Oh. Thank you your comments on the life to sell could do <unk> extension reflected no real concern whatsoever, and it's one of the for new launches you called out for this year. It seems you are completely comfortable with the F.D.A. meeting their regulatory timeline.

Steve Scala: Thank you. Your comments on the LysaCell PDUFA extension reflected no real concern whatsoever. And it's one of the four new launches you called out for this year. It seems you are completely comfortable with the FDA meeting the regulatory timeline. And then secondly, it was stated that COVID-19 could lead to inventory destock and a drop in patient visits to infusion centers in the second quarter, as well as beyond that. I'm just curious, what was the decline in these metrics during the month of April? Thank you.

I just want to make sure that that's the impression you wish to convey to us.

And then secondly.

It was stated that the covert 19 could lead to inventory destocked and a drop in patient visits to infusion centres in the second quarter as well as beyond that I'm. Just curious what was the decline in these metrics during the month of April. Thank you.

Steve Scala: Sure. Thank you, Steve. I think we've already made comments on Lysocell, but I'll ask Samit if there's anything he wants to add, and then David can give you a perspective on the different market dynamics and how we see them impacting the business for the rest of the year.

Sure. Thank you Steve So I think we've already made comments on on lots of cell, but I'll ask assignment. If there's anything he wants to had and then gave in can can give your perspective about different market dynamics and I wish he'd I mean backing division is for.

For that I sent me here.

Giovanni Caforio: Thank you, Giovanni. And thanks to you for the question. So we have said that we remain confident in the data. We remain confident in the data that we submitted to the FDA. It is very normal for the FDA to, as they review the file, ask questions. Certainly, we are looking towards the approval date now for November. During the review process, there may be many more questions that come to us, but that's a very normal process. So I think that's the way to look at it. Obviously, we cannot comment specifically on the types of questions or what they relate to from a regulatory point of view. However, we remain confident, and we are looking forward to bringing this treatment to patients as soon as possible at the end of this year.

Thank you do any and thanks to put a question for life. So what we have said that you'd immune confident in the data remain in the confident in the data there'd be submitted to the F.D.A. is the normal for the F.D.A. to as interviewed a five blocks of questions.

Certainly we're looking towards the approval date now too in November doing the review process. They may be many more questions that come to us, but that's a very normal process. So I think that's that's the that's the way to look at it I, obviously need to not <unk>, specifically on types of questions or <unk>.

Point of view, we remain confident that we're looking forward to bring the streep intubation listening as possible to again this year.

Yeah, and I'm just on the Christian around group stocking that with so so you know as we entered the pandemic situation in February and March and what we saw was you know across for across the board with so 60 stocks are increasing so so wholesalers, making sure they had increasing inventory.

David V. Elkins: Yes, and just on the question around the stocks that we saw. So, you know, as we entered the pandemic situation in February and March, what we saw was, across the board, we saw safety stocks increasing. So we saw wholesalers making sure they had increased inventory. We also saw that pharmacies had extra safety stocks.

So pharmacies.

Huh extra 60, Skunk, and then where even saw with <unk> getting longer scripts since we because we talked about revlimid with an example, grilling doubling the number for hunting <unk>.

David V. Elkins: And then we even saw patients getting longer scripts, as we talked about, Revlimed was an example going, doubling the number of days that they could get. And, you know, we anticipate, as I said earlier, that the majority of that will come out in Q2. So of the 500 million that we talked about, the majority of that comes out in Q2, and then we'll see it coming out, the remainder of that coming out in Q3 and Q4 is what we're anticipating. As far as, you know, what we're seeing in the new patient starts, it's early days, what we're seeing there, but we did see, you know, some of those new Rx's declining about 10 to And then on the infusion center, similar to what we're seeing in that 10% to 20% range as well, fewer patients. So again, that's something that we're going to keep an eye on in the second quarter as well. Chris, I don't know if there's anything that you want to add to that.

<unk>, we're are starting for your Summagraphics docking come out and you know read construed as I said earlier that the majority of that will come out too too. So the 500 million that we talked about muttering about promoting for true and then we'll see coming up remaining different coming out 333 or four sir.

Weren't weren't concentrating as far as you know what we're seeing <unk> <unk> <unk> <unk> <unk>, but we could see you know some of those are new R.X. is <unk> <unk>, 20% depending upon them.

<unk> very close where even the second quarter and walk through you on that.

And Grand on inclusion center on similar we're seeing and that kind of 20% range as well fewer patients.

And that's something that we're gonna keep an eye on.

Quarter as well, Chris I don't know if there's anything you want it and.

I think you I think you've managed the two I hit on the key points. The only other thing I would say is that the the the drop that we've seen in patient volume and and particularly at new patients starts has varied really across Europe unique areas show in the C.D. space, it's been sort of on the order of 20% to 25% across the Oh.

Class, a lesser extent and on college in the tumors that we are in it's been on the order or 5% to 20% and as David Lynch and that is like the some choppiness for example, and not be those sales in April which we think is attributable to the new patients to the dropping new patient starts that said, we would expect that.

As David had mentioned that would the biggest impact for that would be the second quarter or that we begin to normalize and be back to more normal levels by the third quarter by the fourth quarter and natural will be continuing to monitor.

Right <unk>, maybe we can go to <unk>.

Absolutely. The next question comes from.

Chris Boerner: I think you've managed to hit on the key points. The only other thing I would say is that the drop that we've seen in patient volume, and particularly in new patient starts, has varied really across therapeutic areas. So in the CV space, it's been sort of on the order of 20 to 25% across the OAC class, a lesser extent in oncology and the tumors that we are in, it's been on the order of 5 to 20%. And as David mentioned, that has led to some choppiness, for example, in op vivo sales in April, which we think is attributable to the drop in new patient starts. That said, we would expect, as David mentioned, that the biggest impact for that would be in the second.

Dave arising girlfriend Morgan Stanley.

Thanks, very much so congrats on the results and the prospects I have two questions first but you just comment on the yoga and I'm, an opportunity and all sort of kaleidoscope and the expected timing of phase three top line results and then.

I I missed protocol earlier, so I don't know if you've discussed it could you also comment <unk> atrophy on trial read outs to watch and maybe you could focus on the biggest incremental commercial opportunities with respect to those <unk> trials. Thank you.

Thank you David.

So summit and Chris can can address both of your questions.

If you want to start with the data on you know I'll pick up on a commercial opportunity to talk about out of it.

Sure absolutely and then certainly for the data that you're looking forward to for.

Chris Boerner: Thanks, Chris. Maybe we can go to our last one, Joey.

Chloe: Absolutely. The next question comes from Dave Risinger from Morgan Stanley. Thanks very much. So congratulations on the results and the prospects. I have two questions. First, comment on the Xanamon opportunity and all sorts of colitis and the expected timing of phase three top-line results. And then, I missed part of the call earlier, so I don't know if you discussed it, but could you also comment on Updevo adjuvant trial readouts to watch, and maybe you could focus us on the biggest incremental commercial opportunities with respect to those adjuvant trials. Thank you.

<unk> on track of you know trying I've had already computed opened and you're looking towards the third quarter bits here <unk>, Let me do back to Florida, I do and pen names ending packed Chris.

So just on the commercial opportunity in I.E.D., what I would say to build on what what some it started with the around the data is that with both all sorts of kaleida sand Crows disease. As you May know these are chronic conditions that they require multiple treatments to manage any both of those disease area, there really isn't eat or more applications drugs with a manager.

<unk> safety profile in terms of how we think we could play in in in that space, where those animals in the pre biologics space I think there's a need for state convenient options with advocacy. That's that's on the order of what you see with biologics, that's especially true in groans disease, which lacks.

David R. Risinger: Thank you, David. So Samit and Chris can address both of your questions.

Samit Hirawat: Sam, you want to start with the data on IEDs, and then I'll pick up on the commercial opportunity to talk about adjuvants.

Any sort of well established first one treatment and then in the post biologics base, there's really a need for safe options with a different m. away for patients that they did develop in you know just city to biologics in his at summit alluded to the data are still relatively relatively young.

Samit Hirawat: Sure, absolutely. And then certainly for the data that we're looking forward to for Hosanna Mara, Zipozeh, and also the Qaedas, we are still on track. As you know, the trial has already completed enrollment, and we're looking towards the third quarter of this year for the top-line readout. Let me get back to you on adjuvant timelines and the impact, Chris.

Ultimately the opportunity that we're going to have is going to be dated and is there with respect to the adjutant opportunity as we talked about routinely we're excited about the edge of an opportunity to space, where I owe should work given you have an intact immune system. The data that we've seen so far both announcement melanoma without debo, when you're away and some of the early data that we've seen.

Samit Hirawat: So just on the commercial opportunity in IBD, what I would say to build on what Samit started with around the data is that with both ulcerative colitis and Crohn's disease, as you may know, these are chronic conditions that require multiple treatments to manage, and in both of those disease areas, there really is a need for more efficacious drugs with a manageable safety profile. In terms of how we think we could play in that space with Ozanamide, in the prebiologic space, I think there's a need for safe and convenient options with efficacy that's on the order of what you see with biologics. That's especially true in Crohn's disease, which lacks any sort of well-established first-line treatment. And then in the post-biologic space, there's really a need for safe options with a different MOA for patients as they develop immunogenicity to biologics. And as Samit alluded to, the data is still relatively young, and ultimately, the opportunity that we're going to have is going to be data-dependent.

Without D., though and then you add your because setting where we saw about 45% pathological response rate looked very encouraging and we think it's the opportunity to have the biggest impact on patients in terms of those commercial opportunities to be watching out for remember the way to think about a commercially is not only the patients who are treated today, but must like what we saw.

The introduction of I.O. inaccurate melanoma, you really have an opportunity to you would approve the treatment raid. So you need to look at bowl hung patients who are treated today, but also what's the treatment rates. So the ones to keep an eye on would be lung lung as an area where in the U.S. or about 10000 patients treated today, but the treatment rate in adjutant long, it's only about 40.

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Similarly, we're excited about the opportunities in renal cell in a soft ideal those are also potentially large opportunities renal in particular the treatment rate imagining is only about 15% and then obviously, we have ongoing programs and agitated melanoma as well other programs that are are of interest would be gas.

Chris Boerner: With respect to the adjuvant opportunity,

Chris Boerner: We talked about routinely, we're excited about the adjuvant opportunity, it's a space where IO should work, given you have an intact immune system, and the data that we've seen so far, both in adjuvant melanoma with updevo and

Bladder and the nice thing about the portfolio of adding programs. We have is that we've got multiple approaches and we're also looking at traditional adjutant as well as neoadjuvant in Perry edge of it so really excited about the opportunity.

Chris Boerner: Some of the early data that

Chris Boerner: [inaudible]. .. .. .. .. .. .. .. .. .. .. .. ...

Giovanni Caforio: Thank you. Thanks, Chris. So, thanks, everyone, for participating in the call. This was a very strong quarter.

Thank you. Thanks crash. So thanks 71 for participating in the coalition was a very strong quarter I'm very I'm very proud of I would execution engine resilience will buy one organization I look forward to what what we will come into.

Giovanni Caforio: I'm very, very proud of our execution and the resilience of our organization. I look forward to what we will continue to achieve together. In closing, it is clear that the pandemic is impacting our lives. But it's also shining a light on the potential we have as an industry and as a company to transform the lives of patients through science. We're focused on doing our part and continuing to deliver medicines that our patients are depending on. Thanks, everyone. And our team will continue to be available to answer the rest of your questions. Have a good day. Thank you.

Chief together in closing eighties, you have to the pandemic <unk> our lives.

<unk> light on the potential we have as an industry and as a company can transform the <unk> to the science, we're focusing on doing our bar in continuing to the leave her medicines that I would certainly banging on thanks, everyone and I want a team will continue to be available to answer that I still get questions have a good day. Thank.

unknown: This concludes today's call. Thank you for your participation. You may now disconnect.

Yeah.

Let's say it's called thank you for your participation you may not disconnect.

Yeah.

[laughter].

[laughter].