Earnings Call Transcript - BMY Q1 2020

Operator, Operator

Good day, and welcome to the Bristol-Myers 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, Vice President, Investor Relations

Thanks Chloe and good morning everyone. Thanks for joining us this morning for our first quarter financial year results. 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; Nadim Ahmed, President Hematology and Samit Hirawat our Chief Medical Officer and Head of Global Drug Development.

Giovanni Caforio, Chairman and Chief Executive Officer

Thank you, Tim, and good morning everyone. I hope that you and your families are healthy and managing safely through these unprecedented times. 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 workforce. I am very proud of how our teams around the world have responded to the challenge. During this pandemic, it has been abundantly clear that the biopharma 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 disease. Deep scientific knowledge, development expertise, and manufacturing capabilities are what will ultimately help us prevail. I have been impressed by the collaboration and speed with which the industry is responding. On Slide 4, let me start with what Bristol-Myers Squibb is doing to support the global COVID response efforts, focused in four key areas: our science, our communities, our patients, and our team. 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.

David Elkins, Chief Financial Officer

Thank you, Giovanni. Hello everyone and thanks again for joining. I hope that you and your families are staying safe and healthy while we operate virtually. As Giovanni mentioned, I am extremely pleased with the execution of our teams during this unprecedented time. The benefits of our medicines and the strong commercial execution resulted in exceptional performance in the first quarter. Turning to Slide 8, we had strong top-line performance in the quarter with global sales increasing double-digits, growing 13% versus prior year on a pro-forma basis. We saw a significant strengthening of the dollar in the latter part of March and this had a minimal impact in the first quarter; it will be important to keep this in mind as we think about the full-year outlook. Additionally, it is important to note that sales were 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 Eliquis on Slide 9. Eliquis had another strong quarter, growing 37% year-over-year with sales of $2.6 billion globally, largely driven by strong underlying demand.

Tim Power, Vice President, Investor Relations

Thanks David. So could we go to the first question please?

Operator, Operator

Absolutely. So the first question comes from Seamus Fernandez from Guggenheim. Please go ahead.

Seamus Fernandez, Analyst

Thanks very much for the question. So one of the products that you argued is being missed in the Celgene acquisition is CC-486. I was hoping the team could talk a little bit about the commercial prospects for 486 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 either on the 28th and the 29th. So, just hoping to get an update on the rest of the pipeline coming at EHA? Thanks.

Giovanni Caforio, Chairman and Chief Executive Officer

Thank you, Seamus. Thank you very much. This is Giovanni. So, we're very pleased with the priority review designation for CC-486. I'll ask Nadim to give you a perspective on the commercial opportunity there. And then Samit can follow up on your questions regarding data and ASCO and beyond. Thank you.

Nadim Ahmed, President, Hematology

Great. Thanks for the question, Seamus. We remain very excited about CC-486. I think it's important to provide some context. So with AML, it's a very poor prognosis disease even in the newly diagnosed setting where we look at five-year survival rates of around 15% to 25%, depending on the age of patients. 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 CC-486 has delivered a 10-month survival benefit in that setting. So, I think that's really important. And as we think about the opportunity, it's about 33,000 patients overall. If you think about the relapse rates, you can start to consider the epidemiology related to the disease. But the fact that we've added 10 months survival benefit, we've doubled the relapse-free survival benefit. I think we're very excited about the commercial potential, not only in terms of impacting those patients’ outcomes but also the opportunity now to establish a maintenance treatment paradigm in AML, 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 for CC-486. And in terms of durability, we feel very good about our intellectual property position around CC-486. So, we're very excited about the opportunity for patients and for the business of CC-486. Maybe I'll turn it over to Samit now.

Samit Hirawat, Chief Medical Officer and Head of Global Drug Development

Thank you, Nadim, and thanks Seamus for the question. Let me first say, what we are looking at, and then 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 a view of placebo and limited chemotherapy, along with an update with a two-year update for CheckMate-227. In addition to that from a hematology perspective, more specifically, we're looking forward to the first presentation of data from the CARMA trials at ide-cel in multiple myeloma. We are also looking at the liso-cel data update that we seek and, very importantly, continuing with the multiple myeloma team we're looking at the presentation of the data for CC-480 with CELMoD, which is going to be very, very important and exciting. You asked about EHA. EHA will be more of encore presentations following up from ASCO. In addition to that, we're certainly looking at the data sets in terms of the outpatient use of liso-cel as well at EHA. So these are going to be important sets at ASCO, which we will obviously continue to talk about as we go forward.

Seamus Fernandez, Analyst

Thanks.

Tim Power, Vice President, Investor Relations

Thanks, Seamus. Can we go to the next question please?

Operator, Operator

Absolutely. The next question comes from Terence Flynn from Goldman Sachs.

Terence Flynn, Analyst

Great. Thanks for taking the questions. Maybe this is for Chris. You obviously have a number of upcoming launches and just wondering how you're adapting the commercial strategy here with the possibility of the current environment persists 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 liso-cel BLA submission. I was wondering if you can give any more specifics about the FDA request. Thank you.

Giovanni Caforio, Chairman and Chief Executive Officer

Thank you, Terrence. Let me just start. I will ask Chris to comment on your question, and Nadim and also then Samit can follow up on liso-cel. We're taking a very clear approach with launches. The number one priority is the health and safety of our employees and healthcare professionals. We do not want to disrupt healthcare systems right now. We have taken the position to maximize early on our remote capabilities in terms of engaging with our customers in order to respect the challenges of the pandemic. Having said that, while we have global principles, those principles apply differently to different parts of the world. They also apply 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. So Chris and Nadim can give you a couple of examples of how we are applying these principles to our launches and obviously the continued support of our portfolio.

Chris Boerner, Chief Commercialization Officer

Yes, so maybe I’ll start. Terence, thanks for the question. As Giovanni mentioned, we made the decision a number of weeks ago to pull in-person engagement with customers. That said, we have continued both on the medical and commercial side to engage with customers remotely. The good news is that BMS has made significant investments in remote engagement capabilities over the last few years. The teams have a lot of experience, not just for the last couple of months, but for many years in leveraging this technology to engage with customers. As Giovanni mentioned, we've very much taken the point of view that every launch is going to be viewed independently. We will look at how we're going to engage with customers and how we're going to think about those launches given the specifics. For example, you'll recall that when Zeposia was approved in late March, we decided to postpone that launch. We did so because at the time the healthcare system was just bracing for the impact of COVID. We saw about a 25% decrease in new to brand scripts in MS. We frankly didn't feel that the conditions were appropriate to introduce a new medicine without having our commercial and medical teams able to effectively engage with customers. That said, in recent weeks we've begun to see the MS market adapt to the current environment. Importantly, physicians are beginning to actively initiate new therapies. They've began 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 prior to launch. We have received very good feedback on the Zeposia profile. We’re very excited about making that opportunity available. Initially, that launch will heavily index on remote engagements. Again, we have a lot of experience in leveraging that technology. As conditions warrant, we will be able to dial-up in-person promotion. Ultimately, as we always do, we'll use a mix of both in-person and remote engagement to support those launches. We have a lot of confidence in the teams across the commercial organization in our ability to execute these launches. Nadim, anything to add?

Nadim Ahmed, President, Hematology

Sure. Thanks Chris. I mean I'll just say a couple of things. One, we're very excited about the opportunity to launch four first-in-class or best-in-class medicines in the U.S. just this year. The launch preparations are going very, very well with the team. Of course we'll continue to leverage our deep relationships with hematology experts and hematologists and also our commercial infrastructure. So between Reblozyl, liso-cel, ide-cel, and CC-486, that's the potential for four launches in the U.S. this year. Just to give you some flavor of what Chris was saying, we were able to quickly pivot for the MDS launch from an in-live situation, which we filled at the beginning of the year to a virtual launch, and we continue to have good success stories about the ability to access our physicians and customers in general through virtual engagement. So, we're very excited about the launches ahead of us. As Chris said, we've really pivoted to that digital environment. We're finding we're gaining good access. So very excited about those launches. I'll hand over to Samit for the other part of your question.

Samit Hirawat, Chief Medical Officer and Head of Global Drug Development

Thank you, Nadim. And thanks Terence for the question. As it relates to liso-cel, as you know, we submitted the application with comprehensive data sets at the end of last year. The FDA accepted the application for liso-cel 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 for the company to supply information in response to several requests that the FDA has made. The FDA has decided that the information they have received constitutes a major amendment. That's why the PDUFA date has been extended by three months to the 16th of November now. We are obviously committed to ensuring this medicine is available to patients as soon as possible and we continue to meet our milestones. Obviously, we're not going to comment on the specifics of our regulatory discussions. But let me just remark that we remain very confident about the data for liso-cel for these patients with large B-cell 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.

Terence Flynn, Analyst

Thank you.

Tim Power, Vice President, Investor Relations

Thanks Terence. Chloe could we go to the next question please?

Operator, Operator

Absolutely. The next question comes from Geoff Meacham from Bank of America.

Geoff Meacham, Analyst

Thanks for the question. I just had a couple, as a follow-up for David if the environment normalizes this year, maybe still be a lower run rate for some of your new launches. Since if this affects how you think about 2021 in terms of revenue or cash flow, and other opportunities for synergies to be realized on an accelerated basis. And then Giovanni, big picture on the BD front. You talked about deals still being focused on as well integrated cells. Just curious whether the COVID-19 environment offers this view either their priorities or perhaps the size and scope? Thank you.

Giovanni Caforio, Chairman and Chief Executive Officer

Thank you, Geoff. Let me ask David to start and give you a perspective on 2020 and '21. It's really what has been reflected in our guidance. I'll get to your second question immediately after.

David Elkins, Chief Financial Officer

So, thank you for the question. Particularly on guidance, as we're thinking about it, as we said is, right now we think the inventory build-up is going to really sell mainly in Q2 and for the remainder of the year. As far as what we're watching closely for new patient starts in anticipation that that recovers in Q3 and we're back to normal in Q4. As well as the infusion centers and the volumes returning to normal. That would continue into 2021 on. What I would say is that the underlying performance of the business is very strong in the first quarter. As you heard about what the product launches are confidence in those four product launches are coming this year, as well as the product launches next year, that gives us the confidence in reiterating our guidance for both this year and next year. We will keep a very close eye on the macroeconomic factors that could wind up impacting the entire industry as I talked about in my remarks. As far as the synergies, we continually review those synergies both internally as well as with our board. We are really pleased with the progress we've been making on that front. The progress with the third-party vendors has gone very well. As far as getting the organization in place, the vast majority of our placements are done. As far as site selection is concerned, bringing our sites together is moving along as planned as well. We remain confident in delivering our essential targets.

Giovanni Caforio, Chairman and Chief Executive Officer

Thank you, David. Just going back to your question, Geoff. First of all, we are very, 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. Our business continues to perform really well. We’ve made great progress with the pipeline against all key value drivers. We're executing well. I would say we are progressing really well with synergies as well. We have tremendous flexibility from a P&L perspective and from a financial perspective. Going forward, we will continue to be very disciplined in terms of how we think about resource allocation and expenses given evolutions related to the COVID pandemic. 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 the new assets and innovation into the company. I expect that to continue to be the case and it is very possible that there are more opportunities available to us going forward. We are definitely focused on business development as we've always been.

Tim Power, Vice President, Investor Relations

Great. Thanks, Giovanni. Are we ready for the next one?

Operator, Operator

Absolutely. The next question comes from Chris Schott from JPMorgan.

Chris Schott, Analyst

Great. Thanks so much for the questions. Just two for me. The first one, in light of the 9ER study, can you talk about the RCC market and the opportunity you see for Opdivo and Yervoy versus IO TKI combinations over time? 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 you think about net pricing, looking out later this year and into 2021? At the core of the question do you think it's likely that we're going to see some sort of incremental impact to pricing from what's occurring with COVID right now? Thank you so much.

Giovanni Caforio, Chairman and Chief Executive Officer

Thank you, Chris. Let me start. I'll give you my perspective on pricing. Then I'll ask Chris to comment on 9ER and RCC. So, first of all, I would say Chris, the issue of drug pricing is one where we've been in dialogue for a period of time. We, as an industry and as a company, continue to think that there is a real need to reform 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 market-based measures to address the issue of drug pricing in terms of patient affordability, which is the real issue. With respect to your question, it is early days; it is difficult to speculate on the future. 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 significantly impacts the commercial markets. One way to think about it: If you look at our business, where 60% of our business approximately in the U.S. is in the commercial space. Of that 60%, about 25% of our business is in the commercial space. When looking at the dynamics that may play out in the commercial space, 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 may take up COBRA, and any strategy or policy that makes that more affordable would benefit patients. Some of those patients will be eligible for Medicare if they're over 65 and there may be some shifts to government programs like the exchanges or Medicaid, hopefully leaving very few patients uncovered. So, these are all dynamics that we're going to be working through. A lot depends on the shape of the recovery and how long unemployment lasts. But these are the macro factors that we'll be looking through.

Chris Boerner, Chief Commercialization Officer

Yeah, thanks for the question, Chris. We're very excited about the data that we saw with 9ER. I'll start with just an update on where we are with Opdivo plus Yervoy today in the first line renal. If you go back a year, we anticipated that Opdivo plus Yervoy would remain a standard-of-care in the first line, and that's precisely what's happened. We think that's been driven primarily by the impressive long-term benefits seen with Opdivo plus Yervoy. We just saw the 42-month OS update at ASCO GU; that OS was about 56% in the ITT population. That's been the continued strong performance of Opdivo plus Yervoy in the first line. Market share right now sits between 30% and 35% overall, and it’s on the upper end of that range, when you look at the labeled indication we have in intermediate core. We do get some non-promoted use in the favorable population, which is off-label for us of about 15% Opdivo plus Yervoy use there. We’ve seen that the majority of existing IO plus TKI therapies have gotten in the first line renal share has largely been at the expense of TKI monotherapy. Opdivo plus Yervoy has held up really well and, in fact, we've seen a bit of an uptick in Opdivo plus Yervoy over the last few months. 9ER brings exciting data, we're extremely happy to see both the OS and the PFS data that we saw there. We're also very encouraged by the safety profile for 9ER. In terms of how we're thinking about positioning it, it's still early days and we're working through the data, but we think these data compete extremely well against the existing IO TKI therapies. As a result, we believe there's a real opportunity to drive share from both existing IO TKI therapies and from TKI monotherapy in spite of advances in first-line renal, TKI monotherapy is still about 20% to 25% of share, mostly in the favorable population. With respect to the favorable population, we see an opportunity for us; once approved, we will have access to that population promotionally as well. The last thing I would say is that once approved, 9ER really does give us the opportunity to provide patients multiple IO modalities. We'll be the only company to have dual IO but also what we believe would be a best in class IO TKI offering. So very excited about the possibilities that 9ER offers us to help patients and provide another modality.

Tim Power, Vice President, Investor Relations

Thanks, Chris. Chloe, can we go to the next question please?

Operator, Operator

Certainly. The next question comes from Andrew Baum from Citi.

Andrew Baum, Analyst

Thank you. So questions for Samit please. In terms of attending 9LA data at ASCO, what is the follow-up of that data for both OS and PFS? My question is all physicians going to come after that presentation and rethink that strategy for first-line non-small cell lung on the back of that data? Is there enough follow-up there? Second, in terms of the 9ER trial, could you talk to cover that too? I remember that when you ran the Phase 2, there was a question about toxicity and ensuring and using the low dose. So given it's a much more promiscuous TKI, should we assume a favorable or comparable tops profile? Anything you could share that would be interesting? Finally, on TIGIT, Roche's pushing forward very aggressively with that TIGIT antagonist. Merck clearly is interested and active with Azuma's program; it seems not to have been very much. Is that a function of resource allocation or what you're seeing with this particular molecule? Thank you.

Giovanni Caforio, Chairman and Chief Executive Officer

Thank you, Andrew. So Samit, I believe all three elements of the questions are for you.

Samit Hirawat, Chief Medical Officer and Head of Global Drug Development

Thank you, Andrew, as always very thoughtful questions. Certainly from our 9LA perspective, we look forward to the first presentation of the data at ASCO. It's certainly going to be very meaningful as we finished enrollment towards the beginning of last year. At the first readout of the data, the interim analysis, the follow-up was short. We'll be able to share follow-on data from that perspective. It's important to realize a few things that we will be looking towards the data to answer. One is, as we continue to follow on, what happens to that OS curve? Does it start to flatten out? Number one. What happens to that beginning part of the curve that we saw in CheckMate-227 where we have the early progresses and how a limited amount of chemotherapy can impact that? I think those are very important answers that we are looking for as we present the 9LA data. Both treatments need to be considered together with 227 data and the 9LA data in overall patient management. Dual IO inhibition becomes very important along with that shortened duration of chemotherapy for some patients as required. I'll obviously ask Chris to comment from a commercial perspective towards the end of my response. On the 9ER side, a couple of medics will use a dose of 40 milligrams, which will be important in terms of managing the safety profile. As we've already stated, the overall safety profile has been quite manageable. Chris also spoke about, that this provides an opportunity for Opdivo in all risk categories in combination with this potential. Very exciting news there; the trial has met all major endpoints: overall survival, DFS, and response rate, in addition to a very well managed safety profile. I'll finish off on the TIGIT. We are looking forward to the data that Roche will be presenting; certainly a very complex mechanism, as you very well know. We have our molecule, which is in Phase 1. We continue to evaluate the Phase 2. The overall dose profile for that agent has not yet been shared, but we will certainly learn from what Roche is going to present and we will see if we can manage differently. Chris, do you want to add things?

Chris Boerner, Chief Commercialization Officer

Sure. I think that Samit touched on most of the points around 9LA. From a commercial standpoint, we've had discussions with physicians over the last few months about 227 and 9LA. It's important to keep in mind that physicians, we think, need to think of 227 and 9LA together. You'll recall that what we showed was that about 50% of responders were still responding at two years, and we saw this nice flattening of the OS curve. We'll see how that data matures shortly at ASCO. The way physicians perceive 9LA is very much as complementary to 227. They offer the benefit of Opdivo plus Yervoy for those patients who don't need chemotherapy; that’s 227, and 9LA for those who potentially do need chemotherapy. I think that, Samit hit on some key things to pay attention to when the data is presented. A couple of other things worth noting: about half of lung cancer treaters have used Opdivo plus Yervoy either in melanoma or renal, so they’re familiar with the benefit we see there. Those physicians account for about two-thirds of total lung cancer patients. Also worth mentioning is that we have a very experienced team with a track record of establishing Opdivo plus Yervoy as standard care in both tumors in which we’re approved with that regimen. They're incredibly excited and prepared to launch Opdivo plus Yervoy in first-line lung cancer; we are looking forward to the PDUFA date for 227 next week.

Andrew Baum, Analyst

Thank you, Chris.

Tim Power, Vice President, Investor Relations

Thanks, Chris. Chloe, could we get to the next one, please?

Operator, Operator

Certainly. The next question comes from Tim Anderson from Wolfe Research. Please go ahead.

Tim Anderson, Analyst

Thank you. A couple of questions, please. Bristol narrowed its footprint in emerging markets intentionally to focus on geographies where it had more scale and presence. With Celgene folded in, you're a much larger organization. It makes me wonder what the plan is with emerging markets going forward. I don't see emerging markets or China mentioned in the press release or in the slide deck. As we've seen across the industry, geographies like China are very important, especially in oncology. It makes me wonder if there's kind of an untapped revenue stream here. 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 LAG3. If I understand it correctly, you have pivotal LAG3 plus Opdivo in combination data coming up around year-end; this program doesn't seem to be talked about much and investor expectations are low. Should those expectations be low, or do you view this as a high-risk program?

Giovanni Caforio, Chairman and Chief Executive Officer

Thank you, Tim. Let me just answer your first question. Then I'll ask Samit to give you his perspective on the ongoing LAG3 program. I think your point is really important. It is a very good question. You are right that given our focus on oncology, and all the work that we have done over the last few years, we have been focused primarily on the developed world. I must say we have a meaningful presence in developing countries, and when looking at the development of our oncology business particularly, we have had significant success actually outside of the U.S. and Europe in major markets, including Central and Eastern Europe and some key markets in Latin America. As you know, we recently received the approval of Opdivo in China. It is accurate that now we have a broader portfolio and more opportunities to establish a larger presence outside of the tier one top markets. I am confident we have the right capabilities there, and we have a strong base to continue to invest internationally. There is a real opportunity, and there is already a presence of the BMS portfolio that has been successful there. We will 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. Samit?

Samit Hirawat, Chief Medical Officer and Head of Global Drug Development

Thank you, Giovanni. I’ll take on the last three questions. First of all, a lot has happened in terms of drug development in patients with melanoma, and certainly BMS has played a big role in getting the FDA together on both Opdivo and Yervoy. Lastly, as a new mechanism, we are excited about it from the early Phase 1 data we've seen, and also from the biomarker perspective looking at T-cell exhaustion and how to drive the immune system again. This study is going to be very important. The trial is currently enrolling and the investigators remain excited. They continue to enroll patients in the trial. It is on track. From an enrollment perspective, we continue to collect data and look to readout towards the end of the year. In parallel, we’re planning lifecycle management studies for visual indications that you will hear about as we roll them out toward the end of the year or early next year.

Tim Power, Vice President, Investor Relations

Thanks, Samit. Can we go to the next one please, Chloe?

Operator, Operator

Certainly. The next question comes from Matt Phipps from William Blair.

Matt Phipps, Analyst

Thanks for taking the question. First, given the current environment and potential trouble accessing infusion clinics, is there any reason to accelerate the development of our subcutaneous nivolumab and other trials ongoing since 2018 looking at that? Secondly, for the TYK2 small molecule, just want to confirm that psoriasis trials are on track to complete by mid-year this summer, and all the physician assessments can be completed. There's been a lot of formulation work ongoing according to clinicaltrials.gov, and just wondering if any impact on potential filings in new clinical trials are successful?

Giovanni Caforio, Chairman and Chief Executive Officer

Thank you, Matt. So Samit, I think there's two questions on subcutaneous nivo and then the status of the TYK2 program.

Samit Hirawat, Chief Medical Officer and Head of Global Drug Development

Absolutely, thank you. Regarding subcutaneous nivo, we are currently evaluating the status. It is ongoing. Acceleration will depend on the outcomes of the first Phase 1 studies as we look toward dosing and tolerability and safety, which should be available soon. Based on that, we will continue to progress further, bringing it to the patients. For the Phase 2 data, we have certainly seen promising results from Phase 3 trials, both 046 and 047, which completed enrollment. At this time, we are looking at the follow-up of these patients, collecting the data, and cleaning activities so that we can push the database lock. There's no reason to believe that there will be any delays. We're looking toward the end of the year for readout of the first study of 046 and the first quarter of next year for 047 for the psoriasis program. Those are the updates for TYK2 and subcu nivo. Back to you, Tim.

Tim Power, Vice President, Investor Relations

Thanks so much. I know we're starting to run close to the end of our normal time. I think it's time to squeeze in two more questions, Chloe. Could we go to the next one?

Operator, Operator

Absolutely. The next question comes from Steve Scala from Cowen. Please go ahead.

Steve Scala, Analyst

Thank you. Your comments on the liso-cel PDUFA extension reflected no real concern whatsoever. 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. I just want to ensure that’s the impression you wish to convey to us? 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. I'm curious, what was the decline in these metrics during the month of April? Thank you.

Giovanni Caforio, Chairman and Chief Executive Officer

Sure. Thank you, Steve. I think we've made comments on liso-cel, but I'll ask Samit if there’s anything he wants to add, and then David can provide a perspective about market dynamics and how we see that impacting the business for the rest of the year.

Samit Hirawat, Chief Medical Officer and Head of Global Drug Development

Thank you, Giovanni. Thanks, Steve for the question. For liso-cel, we stated we remain confident in the data submitted to the FDA. It is very normal for the FDA to ask questions during their review process. We're looking toward the approval date now in November. There may be many more questions that come to us during the review, which is a typical process. So, that's the way to look at it. I obviously cannot comment specifically on the types of questions or ones that relate from a regulatory point of view; we remain confident and look forward to bringing this treatment to patients as soon as possible toward the end of this year.

David Elkins, Chief Financial Officer

On the question around stocking that we saw, as we entered the pandemic in February and March, we saw safety stocks increasing across the board. Wholesalers made sure they had increased inventory. We also saw pharmacies had extra safety stock. We saw patients getting longer scripts, as we discussed. Revlimid was an example of patients doubling the number of days they could get. We are starting to see some destocking come out, and we anticipate, as I said earlier, that the majority of that will come out in Q2. The $500 million we talked about, the majority will come out in Q2, followed by a remainder in Q3, which we are anticipating. As for new patient starts, early days, but we observed a decline of about 10% to 20%, depending upon different factors. We're going to keep a close eye on that in the second quarter, updating you on that. Furthermore, regarding infusion centers, we've seen a similar range of declines as well—10% to 20%. We will continue to monitor that in the second quarter. Chris, do you have anything you'd like to add?

Chris Boerner, Chief Commercialization Officer

I think you hit on the key points. The only other thing I'd add is that the drop we’ve seen in patient volume, particularly in new patient starts, has varied really across therapeutic areas. In the CV space, it’s been 20% to 25% across the NOAC class, a lesser extent in oncology and the tumors we are in, sitting on the order of 5% to 20%. That said, we believe the most considerable impact will be in the second quarter, beginning to normalize by the fourth quarter, and we will be continuously monitoring that.

Tim Power, Vice President, Investor Relations

Thanks, Chris. Maybe we can go to our last one, Chloe.

Operator, Operator

Absolutely. The next question comes from Dave Risinger from Morgan Stanley.

Dave Risinger, Analyst

Thanks very much. So congrats on the results and the prospects. I have two questions. First, could you just comment on the ozanimod opportunity and its role in ulcerative colitis, and the expected timing of Phase 3 top-line results? Secondly, could you comment on Opdivo adjuvant trial readouts to watch? Maybe you could focus on the most significant incremental commercial opportunities concerning those adjuvant trials. Thank you.

Giovanni Caforio, Chairman and Chief Executive Officer

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

Chris Boerner, Chief Commercialization Officer

Samit, do you want to start with the data on IBD and I’ll discuss the commercial opportunity?

Samit Hirawat, Chief Medical Officer and Head of Global Drug Development

Sure, absolutely. We are still on track with ozanimod in ulcerative colitis, with the trial having completed enrollment. We're looking toward top-line readouts in the third quarter of this year. As for adjuvant opportunities, Chris?

Chris Boerner, Chief Commercialization Officer

So just on the commercial opportunity in IBD, as you know, these are chronic conditions requiring multiple treatments to manage. Both in ulcerative colitis and Crohn's disease, there is a need for more efficacious drugs with manageable safety profiles. In terms of how we see Ozanimod fitting in, we believe there is a need for safe, convenient options with efficacy on par with what you see with biologics. This is especially true in Crohn’s disease, which lacks well-established first-line treatments. Additionally, in the post-biologic space, there is a need for safe options with different mechanisms of action as patients develop immunogenicity to biologics. The opportunity we have will be data-dependent. On the adjuvant opportunity, we are excited about it. IO should work, given that you have an intact immune system. The data we've seen so far, both in the adjuvant melanoma with Opdivo and Yervoy, and early data from the neoadjuvant settings, where we saw a 45% pathological response rate looks promising. These opportunities can make a significant patient impact. The trials of interest will be lung, renal cancer, and esophageal, alongside melanoma. With the multiple adjuvant programs we have, there is a sound approach supporting both traditional adjuvant and neoadjuvant treatment.

Giovanni Caforio, Chairman and Chief Executive Officer

Thank you. Thanks, Chris. This was a very strong quarter. I am very proud of our execution and the resilience of our organization. I look forward to what we work on to achieve together. In closing, it is clear that the pandemic is impacting our lives. It is also shining a light on the potential we have as an industry and as a company to transform the lives of patients through our 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.

Operator, Operator

This concludes today’s call. Thank you for your participation. You may now disconnect.