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Celgene Corporation (NASDAQ:CELG)
Q1 2018 Earnings Conference Call
May 4, 2018, 9:00 a.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Good morning and welcome to the Celgene investor and analyst conference call. I would like to remind you this call is being recorded. I would like now like to turn the call over to Patrick Flanigan, Corporate Vice President of investor relations at Celgene.

Patrick E. Flanigan III -- Corporate Vice President

Thanks, Crystal and welcome everyone to our first quarter earnings conference call. The press release reporting our financial results in addition to the presentation for today's webcast can be accessed by going to the investor relations section of the corporate website at www.celgene.com.

Joining me in the room today with prepared remarks are Mark Alles, our Chairman and Chief Executive Officer, Peter Kellogg, our Chief Financial Officer, Terrie Curran, Global Head of our Inflammation and Immunology franchise, Jay Backstrom, our Chief Medical Officer, and the Global Head of our Hematology and Oncology franchise, Nadim Ahmed. Also available for the Q&A for the portion of the call are Jonathan Biller, who heads up our Tax and Treasury group, and Rupert Vessey, Global Head of our Research and Early Development group.

As a reminder, during today's call, we will be making forward-looking statements with regard to our financial outlook in addition to regulatory and product development plans. These statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted. A description of these risks can be found in our most recent 10-K on file with the SEC. These statements speak only as of today's date and we take no duty to update or advise them. Reconciliation of the adjusted financial measures to the adjusted GAAP measures are available as part of the earnings release.

I would now like to turn the call over to Mark.

Mark Alles -- Chairman and Chief Executive Officer 

Thanks, Patrick. Good morning, everyone. Thank you for joining us today. We appreciate the opportunity to review our excellent first quarter results, the meaningful progress our teams have made in advancing key research and development programs, and to provide a detailed update on the Ozanimod NDA for relapsing multiple sclerosis.

Let me start the call by offering my perspective on the state of Celgene. Operating excellence has long been the foundation for us to build our company into a global leader in hematology, oncology, and major inflammatory markets. It has also been the bedrock for confidence, credibility, and the key to creating value for all stakeholders.

Our commitment to building a preeminent biopharmaceutical company has never been greater. In Q1, management took the time to evaluate and understand what we need to do better to achieve this long-standing goal. We have changed people and processes, embedded key learnings and are on track to deliver on the promise of this year and well beyond.

We are entering a critical period for our mid to late stage pipeline. Over the next 12 to 18 months, we expect meaningful value inflection points coming from multiple pivotal data readouts and regulatory milestones. During their prepared remarks, Nadim and Terrie will highlight many of these catalysts and Dr. Backstrom will describe the significant regulator progress we have made to define the path forward for Ozanimod.

As announced in our earnings press release, we now expect to resubmit the NDA and to submit the MAA for Ozanimod in relapsing multiple sclerosis during the first quarter of 2019. Looking past Ozanimod, our first quarter 2018 financial results and progress building Celgene were exception. This strong start to the year continues, leading us to raise our 2018 revenue guidance to the higher end of the previous range, approximately $14.8 billion and positions us to exceed the previous adjusted EPS range of $8.70 to $8.90 prior to accounting for the impact of the Juno acquisition.

I'd like to think the Celgene and Juno teams for coming together so well following our Q1 acquisition of this immunotherapy pioneer. With the continued outstanding progress we were making on JCAR017 in lymphoma and with our partner Bluebird Bio on the development of BB2121 in myeloma, Celgene is now very well positioned to become a leader in the field of cellular immunotherapy.

Additionally our global therapeutic and commercial leadership in myeloid diseases was expanded by the early first quarter acquisition of fedratinib, a highly selective JAK2 inhibitor for the treatment of myeloid fibrosis. We expect to submit the NDA for this important new therapy later this year.

Beginning in 2019, these promising developmental stage hematology products have the potential to incrementally add topline sales. Just the expected launched of fedratinib and JCAR017 in 2019 will enable us to absorb the financial impact cause by the delay in the expected launch of Ozanimod. Based on our most current forecasts, we are again reaffirming our 2020 outlook, revenue of $19 billion to $20 billion and adjusted diluted EPS of greater than $12.50.

Finally, we are continually evaluating opportunities to strengthen our organization to fully capitalize on our next wave of innovation, key examples include the recently announced changes to our board of directors, adding three new directors with expertise in areas critical to our future success.

In early April, we changed our executive management structure to enhance communication, accountability, and focus on building Celgene for long-term success. In areas of increasing complexity and scale, we are adding highly experienced executives to improve strategic thinking and operating excellence. At the start of this week, we announced the appointment of our new Senior Vice President for Global Regulatory Affairs, Dr. Jennifer Dudinak, reporting to our Chief Medical Officer, Jay Backstrom. Jennifer has been added to our Global Executive Committee. We plan to continue to update you on new executive appointments as they happen.

Our very good start to the year, multiple near-term catalysts, continued balanced deployment of capital and recent success strengthening our organization give us renewed confidence that we're effectively enhancing our strategy for continued growth. The management team is aligned, focused, and committed to delivering on our potential, starting with our excellent first quarter performance. Thanks again for joining us today. Please welcome Peter, who will provide a detailed review of our operating results.

Peter Kellogg -- Chief Financial Officer

Thank you, Mark, and good morning, everyone. We are off to a strong start in 2018, where the momentum seen in the fourth quarter last year has been continuing into the first quarter. Our performance also continues to be driven by volume or usage of our therapies globally. We take a strategic and balanced approach to our capital deployments. In Q1, our investments in two acquisitions further built our pipeline for future growth, while at the same time, our share repurchase program continued. Celgene's strong performance in Q1 has led us to update our full-year guidance, which I'll discuss shortly.

Turning to our Q1 performance, net product sales grew 20% year over year to $3.5 billion. Our growth continues to be primarily driven by volume, with 15.5% of the total 19.6% percentage points of revenue growth coming from volume. This strong growth was achieved across the portfolio with key contributions from the major brands, Revlimid, Pamalyst, Otezla, and Abraxane. Nadim and Terrie will discuss these results in a few minutes.

This topline momentum was successfully converted into strong Q1 earnings. Our adjusted EPS increased 23% versus prior year. In fact, our momentum actually drove Q1 earnings over those of Q4 last year, which is particularly strong, given that we were observing the additional expenses, including the R&D of our two acquired companies' major pipeline programs.

This performance was achieved through outstanding operational growth. As you can see from this chart, operating income, on the right, grew $0.34 per share or 20%. While despite absorbing the additional operating expenses of both companies. Below the operating income line, we offset both the additional debt issues in support of our acquisition and the slightly increased tax rate that arose from US tax reform through the benefit of the opportunities share repurchases executed in the weak market during both Q4 and Q1.

Turning to the P&L line items, both R&D and SG&A were in the 19% to 20% of revenue range for the quarter. The adjusted operating margin remains quite strong at roughly 58%. Our tax rate was 17.3%, reflecting both the impact of US tax reform and the acquisition of Juno.

We ended the quarter with $4.74 billion in cash and marketable securities. During the quarter, we deployed over $10 billion to acquire two important late-stage pipeline companies -- Impact Biomedicine and Juno Therapeutics. Supporting these strategic actions, we issued $4.5 billion of debt. In Q1, we purchased $2.7 billion of shares, bringing our total share repurchases over the last two quarters to $5.7 billion, reflecting our belief that the recent share price pressure presents a compelling investment opportunity.

For the full year 2018, we anticipate total share repurchases in line with our historic program in financial policy. In the first quarter, our board also reautheorized $5 billion for the share repurchase program, of which approximately $3.1 billion remains outstanding as of March 31st.

Finally, I'd like to mention one additional note. In our GAAP results this quarter, our investments in equities are now subject to two new accounting standards, which require equity investments with readily determinable fair values to be measured at fair value at the end of each quarter, with the corresponding impact interlocked to net income. This is essentially a market to market.

Implementation requires two steps -- first, the cumulative catch-up of our equity portfolio gain loss performance was booked and recorded to our balance sheet and retained earnings. This amounted to a cumulative gain on our equity investment of $875 million. This brought us up to current for yearend 2017.

Now, secondly, in Q1, our portfolio had achieved an additional significant gain of $959 million just in Q1, which is in our GAAP results under other income, but this gain is excluded from our non-GAAP P&L since we view it as really non-operational. This treatment will be applied in future quarters, hence, future gains or losses each quarter on this new market to market standard will be adjusted out of our non-GAAP P&L henceforth.

Finally, we have updated our 2018 guidance based on our strong start to 2018 and expect a continued momentum. The updated guidance chart shown here also incorporates the dilution from the Juno acquisition as a separate column to aid in your review. The total revenue guidance has been raised to the higher end of our previous range and is now approximately $14.8 billion. Revlimid net sales are now expected to be approximately $9.5 billion. Pomalyst net sales are now expected to be $2 billion. Expected net sales for Otezla and Abraxane remain at approximately $1.5 billion and approximately $1 billion, respectively.

Operating margin is now expected to be approximately 56%, incorporating the R&D and SG&A expenses from our strategic transaction. The adjusted tax rate is now expected to be approximately 17%. Now, without the Juno acquisition, adjusted EPS would now be $0.05 per share above the higher end of the previous guidance range of $8.70 to $8.90. Incorporating dilution from the Juno acquisition sets adjusted EPS guidance for the year at approximately $8.45. Please note that going forward, weighted average diluted shares are expected to be about $755 million.

So, in summary, a very strong quarter. This strength has been reflected in our updated full-year outlook. Thank you. I will now turn the call over to my colleague, Terrie.

Terrie Currant -- President, Inflammation and Immunology

Thank you, Peter, and good morning. The first quarter was another strong quarter for the Inflammation and Immunology franchise, highlighted by significant year over year revenue growth for Otezla. We've initiated multiple activities that have the potential to expand the treatment eligible population for Otezla worldwide, laying the groundwork for future growth opportunities.

Ozanimod is an important priority for Celgene. We've had productive interactions with US and European regulators to resubmit the US NDA and submit the European MAA for MS in the first quarter of 2019. We were encouraged by the recent data presented at AAN, which reinforced Ozanimod's potential for a differentiated clinical profile. Dr. J. Backstrom will provide a detailed regulatory update in a few minutes.

We remain committed to advancing novel oral therapies in inflammatory bowel disease with Ozanimod and Otezla and will discontinue the development of GD0301.

Otezla had another strong quarter as worldwide sales grew to $353 million, representing a 46% growth in both sales and volume versus Q1 of 2017. Otezla sales growth in the US was primarily volume driven due to increasing volume demand and improving access pull through in contracted health plans. Otezla's year over year growth in international sales of 75% was largely driven by increasing adoption in key ex-US markets.

While performance in lead indicators year to date are very solid, we are holding to Otezla guidance at this point, as we observed variability in price in a month when category growth has historically softened.

2017 was an important year for Otezla, with a number of managed care contracts implemented in the US. Additionally, Celgene was able to secure differentiated access positions for key international markets such as France and Japan.

Now into 2017, there are numerous global initiatives under way to further advance the future Otezla opportunity, including programs for potential new indications, such as mild to moderate plaque psoriasis and Bechet's disease, label enhancement such as scalp psoriasis and a once-daily formulation.

Psoriasis is an increasingly crowded market with physicians evaluating multiple treatment options for their patients. As an oral therapy for moderate to severe plaque psoriasis, Otezla has established a solid position in the pre-biologic, post-topical setting. We remain focused on further expanding this opportunity.

So, only one quarter of the way through 2018, we're observing share gains in contracted US healthcare plans. Access pull through has been enhanced by a multichannel strategy to accelerate new starts in patients with moderate to severe plaque psoriasis, including a new direct to consumer campaign launched in February. The strategies we've implemented have resulted in a pre-biologic segment accounting for the majority of Otezla volume.

France and Japan represent major contributors to the long-term brand performance of Otezla and they both demonstrate continued acceleration in patient uptake. In France, Otezla leads in share of new patient starts, securing greater than 30% of their dynamic share. And after only 10 months post-launch in Japan, Otezla is the branded market leader in systemic psoriasis.

We're pleased to start 2018 with a very strong quarter and look to execute against mild step stones of expanding our portfolio. With Otezla, we have a strong foundation to build on the momentum realized over the last two years. We're actively pursuing the lifecycle of this important asset and remain committed that to expanding the pre-biologic opportunity for appropriate patients.

We're encouraged by the recent data presented at AAN regarding both the safety and efficacy profile of Ozanimod with relapsing MS, reinforcing the potentially differentiated profile we saw in the pivotal program. Our novel IBD portfolio continues to evolve and progress. The Ozanimod Phase III TRUE NORTH trial in moderate to severe ulcerative colitis is well under way and is now targeted to complete enrollment by 2019.

This is a large trial in a very competitive landscape. We're also beginning pivotal program initiation activities for Otezla in mild to moderate ulcerative colitis, which represents another large underserved patient population. The I&I team is focused on executing against our strategic priorities, delivering value from our growing portfolio of assets and disease targets across multiple phases of development.

I would now like to introduce Dr. J. Backstrom, who will provide an Ozanimod regulatory update.

Jay Backstrom, MD -- Chief Medical Officer

Thank you, Terrie. Good morning. We have made significant progress since our call with you in February toward the resubmission toward the NDA for Ozanimod in relapsing multiple sclerosis. Before I describe our progress, I want to take the opportunity to review the results of the SUNBEAM and RADIANCE trials that will form the basis of our regulatory submission.

As previously discussed and recently presented at AAN, both studies met the primary endpoint, demonstrating a significant reduction in annualized relapse rate compared to beta interferon. As noted in the updated safety presentation at AAN, Ozanimod was generally well tolerated, as reflected in the low incidents of serious adverse events, with less than 5% of patients discontinuing treatment due to adverse events. No patients experienced second degree or higher AV blocks and the rate of infection was comparable in treatment groups. Together, these results support a favorable benefit-risk profile.

Turning to our progress toward resubmitting the NDA for Ozanimod, as we indicated on the February call, the key issues for refusal to file centered on the completeness of the clinical pharmacology and the non-clinical portions of the NDA. These issues relate to the major active metabolite CC112273.

To put CC112273 into context, after acquiring receptors, Celgene initiated several clinical pharmacology studies for Ozanimod, including a radio labeled human mass balance study. These additional studies were initiated at a time when the phase III RMS program comprised of the two FDA-approved protocols, RADIANCE and SUNBEAM was u under way.

The results of the human mass balance study identified CC112273 as a major metabolite accounting for approximately 90% of the activity. CC112273, which has a similar strategy and the same selectivity and potency as Ozanimod for the S1P1 and S1P5 receptors is disproportionately formed in humans and was not identified as a major metabolite in the non-clinical pharmacology. The PK profile of CC112273 is similar to Ozanimod with respect to Tmax, six to ten hours, with a half-life of 10 to 13 days.

Based on the totality of the clinical data, including safety in approximately 4,000 patients, the similarity of CC112273 with respect to structure, selectivity, and potency for the S1P1 and S1P5 receptors, we proceeded with the NDA submission. However, FDA requested further characterization of CC112273.

Since our call in February, we submitted a plan to address the information required by the FDA and participated in a type A meeting to review and discuss our plan. Based on our discussions with FDA, we plan to address the non-clinical safety assessment of CC112273 by bridging to the existing non-clinical study and to address the clinical pharmacology assessment for CC112273 by utilizing the PK-PD data from the completed and ongoing clinical study.

This work is well under way and will be incorporated into a new submission, now targeted for Q1 2019. In addition, we held discussions with the European Medicines Agency and are planning to submit the MAA in Q1 2019 as well. We fully expect our regulatory team to deliver a high-quality submission by Q1 2019.

Considering the pivotal efficacy and safety data will be based on the two phase III studies, SUNBEAM and RADIANCE, we are well-positioned to achieve regulatory success. I will now turn the call over to Nadim.

Nadim Ahmed -- President, Hematology and Oncology 

Thank you, Jay, and good morning, everyone. The hematology and oncology franchise had a robust first quarter, with total revenue of $3.2 billion at 17% year over year growth. Revlimid and Pomalyst continued to drive our overall growth with market share and Eurasian gains across geographies. Based on this positive momentum, we have now raised our 2018 guidance for our myeloma brand. We are awaiting several key phase III data readouts later this year, including Revlimid in lymphoma, Abraxane in adjuvant pancreatic cancer and our pivotal phase III program with Luspatercept in low-risk MDS and beta-thalassemia.

We also continued to make progress with the advancement and expansion of our pipeline programs. We closed our acquisition of Juno Therapeutics in March and are positioned to rapidly advance JCAR017 toward submission and approval. Enrollment has completed in the pivotal TRANSCEND US trial in third line plus diffuse large B-cell lymphoma. The pivotal BB2121 KarMMa trial in in fourth line plus multiple myeloma is currently enrolling. We are also advancing JCARH125, another BCMA CAR T therapy, into the clinic, building on our strategy to become a global leader in cellular immunotherapy.

We expanded our near-term myeloid platform with the acquisition of Fedratinib. We have also made progress with other multiple myeloma pipeline assets. A phase one study of our now cell mod CC-92480, has started. We also moved CC-93269, our BCMA T-cell engager antibody into the clinic.

Revlimid had a very strong first quarter, with global sales growth of 19% year over year. In the US, the brand grew 21%. Market share and duration continues to increase. We continue to see a positive impact from the non-stem cell transplant and post stem cell transplant maintenance launches. We expect to see continued increases in duration from the use of triplet combination regimens.

Outside of the US, Revlimid net sales grew 15% year over year, with 21% volume growth. Revlimid share in front line, non-stem cell transplant patients continues to grow outside the US. We are also seeing duration increases with the impact of Revlimid-based triplets. Beyond multiple myeloma, we also expect to see additional phase III data this year from our lymphoma program. We also expect multiple phase III data readouts for ongoing studies utilizing Revlimid-based triplet regimens in the frontline setting of multiple myeloma throughout 2018.

Pomalyst/Imnovid net sales increased by 24% year over year. In the US, Pomalyst net sales grew 39%, driven by duration and share gains. Pomalyst is growing rapidly with the adoption of the triplet regimen of Pomalyst, Daratumumab, and Dexamethasone for relapsed refractory myeloma. Similar to Revlimid, we expect to see additional Pomalyst share and duration gains to the use of triplet regimens.

Outside of the US, Pomalyst/Imnovid revenue grew 3% year over year. Volume increased by 13% in spite of competition from new entrants. Revenue growth was affected by price reductions in some markets. The OPTIMISM trial reported out earlier this year and achieved its primary endpoint of PFS improvement, with an oral presentation at the upcoming ASCO meeting.

Abraxane continues to maintain stable demand overall. We did see an increase in revenue in the first quarter, which was positively impacted by buying patterns across the globe of approximately $30 million. The positive results of the Impower131 trial in first line squamous non-small cell lung cancer for Abraxane in combination with Atezolizumab will be presented at ASCO as an oral presentation. We look forward to additional Abraxane data readouts later in 2018 for the APACT Adjuvant pancreatic cancer trial as well as the IO Abraxane Atezolizumab trials in triple-negative breast cancer and non-squamous, non-small cell lung cancer.

Our teams are preparing for a robust presence at ASCO this year, including the oral presentation of the phase III OPTIMISMM study results of Pomalyst in combination with Bortezomib and Dexamethasone in second line plus multiple myeloma. The phase III RELEVANCE study comparing R-squared versus the gold standard of Rituximab plus combination chemotherapy has also been accepted as an oral presentation.

We will also see updated CAR T data from the upcoming phase I BB2121 dose escalation study in relapsed refractory myeloma and JCAR017 in diffuse large B-cell lymphoma, which have both been accepted as oral presentations. As mentioned earlier, the phase III IMpower131 trial with Abraxane in combination with Atezolizumab has also been accepted as an oral presentation.

In summary, the Hematology and Oncology franchise had an excellent first quarter in 2018. We are very pleased with our sales performance with strong volume growth, across brands and regions. We have many upcoming catalysts with near term phase III data readouts for Revlimid in lymphoma, Luspatercept in low-risk MDS and beta-thalassemia, as well as Abraxane in Adjuvant pancreatic cancer.

We also plan to file the NDA for Fedratinib later this year. Our pipeline also continues to progress. We are advancing a multiple myeloma strategy with two major campaigns, BCMA-targeted therapies and our new cell mods. We look forward to sharing our pipeline strategies during our upcoming multiple myeloma deep dive meeting on May 24th.

Our ambition in lymphoma continues with the progress of Liso-cel and CC-122. Additional pipeline assets entering into pivotal programs this year include Tislelizumab in non-small cell lung cancer, Marizomib in glioblastoma, and Luspatercept in frontline MDS, representing the advancement of our cancer pipeline across a wide range of unmet medical needs.

Thank you. I will now turn the call back over to Mark.

Mark Alles -- Chairman and Chief Executive Officer 

Thank you, Nadim. Thanks, Terrie, Jay, and Peter and thanks to your teams for delivering an excellent start for the year. As you heard, our business momentum is strong. We're very confident that regulatory path for Ozanimod in MS in understood and back on track. In the next 12 to 18 months, we anticipate multiple catalysts for realizing our long-term growth to 2020 and beyond. Thanks for your attention this morning. Operator, please open the call for questions.

Questions and Answers:

Operator

Thank you. Ladies and gentlemen, if you have a question at this time, please press the * followed by the #1 key on your touchstone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the # key. Once again, to ask a question, please press * and then 1 now. Our first question comes from Geoff Meacham from Barclays. Your line is open.

Geoff Meacham -- Barclays -- Managing Director

Hey, guys. Thank so much for the question. Just have a few related ones for Jay on the Ozanimod filing. I know it's a stepwise process, but does your first quarter filing, does it require another regulatory meeting? I'm just wondering if there's room for it to be faster or risk that more work may be needed. Then related for Mark, given the Ozanimod delay, how much of a strategic priority really is neuroscience compared to other categories at Celgene. I know you guys just signed the Prothena deal. I just want to get some context for it. Thank you.

Jay Backstrom, MD -- Chief Medical Officer

So, hi, this is Jay. Just to start, from the type A meeting, as I reflected in my comments, I feel like we have a path forward in our understanding of what needs to be done. So, that's in motion. But just to underscore, this is a new NDA. We intend to have a pre-NDA meeting as we would for other programs. So, that will happen as we get closer to the end.

Mark Alles -- Chairman and Chief Executive Officer 

Geoff, it's Mark. Thanks for the question about neuro. Let me start by saying that we're very confident in the path forward for Ozanimod in MS and I don't think that is a direct link to what we think broadly or specifically about neuroscience. We're taking a stepwise approach to neuro, as you know.

We have a Prothena deal, which is exploratory on a number of known proteins in neurodegenerative disease. I'll remind you we have a partnership with Evotec to screen chemical matter for certain hits in neur. I would say that in MS, we have a full commitment to optimize Ozanimod. Then beyond that, we're being very, very thoughtful and programmatic in how we understand a broader, deeper approach to neurosciences.

Geoff Meacham -- Barclays -- Managing Director

Okay. Thanks.

Operator

Thank you. Our next question comes from Brian Abraham. He's from RBC Capital Markets. Your line is open.

Brian Abraham -- RBC Capital Markets -- Analyst

Hey, guys. Thanks very much for taking my question. I questions another question on Ozanimod -- maybe you could clarify a little bit more specifically exactly maybe what still needs to be done, how much has been done so far, whether you see any particular risks to the results meeting FDA and EMA's comfort and whether or not the longer half, if there's any risk with the longer half-life and accumulation there and then lastly, whether this issue may play into ultimate comfort around labelling and understanding the safety profile to potentially not have class labeling on cardiac monitoring. Thanks.

Jay Backstrom, MD -- Chief Medical Officer

This is Jay. Maybe I'll start kind of in reverse order, talk about the safety. I think it's important to recognize the safety data we presented in these public settings really reflect Ozanimod and all of its half-life. So, that safety profile, I think, takes that into consideration, which I think is a really important point, particularly considering now we have close to 4,000 patients on study and some well over two years of exposure. I think we have a very nice safety database.

In terms of the work, the work is following through on our conclusions from the type A meeting over the bridging work with the non-clinical legacy studies and so those are well under way. Our team is very good at generating that data. And then to continue to work on the clin-pharm package and characterize that, which again, from our timing, we are comfortable we should have that concluded in time to maintain the Q1 submission.

Operator

Thank you. Our next question comes from Umer Raffat from Evercore. Your line is open.

Umer Raffat -- Evercore ISI -- Analyst

Hi, thanks so much for taking my question. I have one for Mark and a couple for Jay, if I may. Mark, Dr. Reddy's decided not to move forward with the Markman hearing. I'm curious as to why and how that happened and what that means. Jay, two for you -- first, if you look at the lymphocyte recovery period with Gilenya, it was about three to four weeks or longer and that's what Receptos management used to flag a lot.

Then for Ozanimod, the lymphocyte recovery period was about three days and that was an important differentiation. I guess my question is have you looked at the lymphocyte recovery period with this metabolite. I ask because the metabolite is 90% of Ozanimod AUC. So, in theory, is it the same as three days or is it materially longer?

The other one for me is -- maybe this is a very basic drug development question -- if the half-life of this metabolite is 10 to 13 days and the metabolite is 90% of AUC, then why isn't the dosing weekly or every other week? Thank you very much.

Mark Alles -- Chairman and Chief Executive Officer 

So, Umer, it's Mark. I guess I'll start with Dr. Reddy's question. The claim construction argument was resolved. So, of course, then a Markman hearing was unnecessary. We are defending our patent state. The 30-month stay, as everyone knows, is early March of 2019. That's the status of Dr. Reddy's and Celgene right now. Thank you.

Jay Backstrom, MD -- Chief Medical Officer

Yeah, with respect to the half-life and the lymphocyte recovery, just a couple points -- I think one, first, to recognize we still have a lot of patients on trial and to characterize that, we'd really be dealing with a subset. Part of our work as we look forwarding this year would be to further characterize that. So, we'll have further insight into that as we go let the year proceed.

With respect to your interesting question around dosing, interesting question. Of course, at this point in our program, I think we're going to stick with the daily dosing that we have.

Operator

Thank you. Our next question comes from Geoffrey Porges from Leerink. Your line is open.

Geoffrey PorgesLeerink Partners -- Managing Director

Thanks. Jay, I have to follow-up on these questions on 2273, the metabolite. So, could you tell us how the metabolite itself is metabolizing and then even if it's not synthesized and it doesn't appear in animals, why can't you synthesize it and give it to animals? Do you know what the safety liabilities of the metabolite are when it accumulates in animals or people? Thanks.

Jay Backstrom, MD -- Chief Medical Officer

Yeah. So, first, the metabolic profile is similar to the parent, Geoff. So, it's quite similar in terms of how it's metabolized. With respect to your second question about how to asses it in animals, I think you laid out two potential strategies. One is to get the parent where you have sufficient exposure to detect it. The other would be to consider synthesizing metabolite and going ahead and actually giving that to animals. So, where we are currently is we're making sure that we have the opportunity to demonstrate that we have adequate exposure through that bridging and through potentially concerning those strategies, so at the end, the non0clinical reviewer feels like they have sufficient data.

Geoffrey PorgesLeerink Partners -- Managing Director

Okay. Thanks.

Patrick E. Flanigan III -- Corporate Vice President

Crystal, I think Mark has a couple of additional comments before you go to the next caller.

Mark Alles -- Chairman and Chief Executive Officer 

Back to Umer's question about Dr. Reddy's -- the 30-month stay, it actually expires August of 2020. I misspoke. Then the question about does the trial get scheduled -- we don't see a trial at all this year. It's very, very difficult to know if something would be scheduled for 2019. So, thank you.

Operator

Thank you. And our next question comes from Robyn Karnauskas from Citigroup. Your line is open.

Robyn Karnauskas -- Citigroup -- Analyst

Hi, guys. Thanks for taking my question. Two things -- since you've been in these long discussions with the FDA, is there anything you have, the metabolite, which seems a little different than Gilenya -- could you give us a sense of whether or not you got a sense that you could definitely not have a first post-monitoring label if the FDA says to you this is a differentiated product? Secondly, any updated thoughts of would you launch if you do not get that label?

Then lastly, for Mark, you mentioned that you thought really hard about the company first quarter and what kind of changes need to be made. Can you go into depth about your thinking and what you think needs to happen with the company going forward, like what mistakes will be made, what changes need to be made? Thanks.

Jay Backstrom, MD -- Chief Medical Officer

So, this is Jay. Maybe I'll start with the question about monitoring with the differentiated label. Again, I'm going to go back to the way the program was conducted with the opportunity to [inaudible], the underscoring that there's no effect on QT, the selectivity, etc. and that the data that we have today reflects the totality of the data from Ozanimod and metabolite. I don't think we're in any different place today on 112273 than we were before. I think those data are what they are. We'll continue, of course, to round out the clinical pharmacology program through the way I described, bridging back to the existing PKPD data. But I don't think this changes that potential.

Mark Alles -- Chairman and Chief Executive Officer 

Robyn, thanks for the question on Celgene and the state of Celgene. I think a number of important steps have been taken to really improve off of what was already a pretty good baseline of operating excellence, the accountability of strategic planning, this notion of better communication, leadership focus on value drivers. I think a lot of what we've done now has been embedded into who Celgene is and then on a go-forward basis, we feel like we're in a very good place.

As I said, the management team came together, spent a lot of time thinking about certain elements of our performance, starting with that, as you see from the results, we're executing very well in our core commercial areas. The regulatory experience with Ozanimod is something that we've dissected and worked through so that the path forward is very well-understood and anything that we learn from that has been applied and worked through.

So, we think about first, Ozanimod, but then future regulatory opportunities. I think really the changes we've made amplify our ability to think more strategically and to make sure that we don't make assessments, judgements, or assumptions about where we are at a given period of time. I think we're in a really good place. In terms of go forward, I like the structure and I like the team a lot. I think we're in a great position to execute for this year and beyond.

Robyn Karnauskas -- Citigroup -- Analyst

Thank you.

Operator

Thank you. Our next question comes from Cory Kasimov from J.P. Morgan. Your line is open.

Cory Kasimov -- J.P. Morgan -- Analyst

Hey, good morning, guys. Thank you for taking my question. I wanted to also ask about Ozanimod but from the perspective of UC. So, it looks like enrollment for the pivotal phase III TRUE NORTH study slid somewhat again. I'm just curious whether or not accrual was slowed down in response to the RTF to gather more information or was this just about the competitive landscape you referred to in the prepared comments as well as in the past. Thanks.

Jay Backstrom, MD -- Chief Medical Officer

Yeah, Cory, this is Jay. Maybe I'll start. It's the competitive landscape. There's a lot of programs. We're being careful to select, but this is a difficult place to recruit patients. So, I don't believe it's related to the RTF.

Terrie Currant -- President, Inflammation and Immunology

Yeah, it's Terrie here. I'll just go to what Jay said. There's over 60 programs ongoing in either phase II or phase III in moderate to severe ulcerative colitis. We've executed a number of initiatives to try to accelerate the trial. We've recruited over 60% of the biologic exposed patients. Now, importantly, we're focusing on those that haven't had exposure to biologics. In the last month, we had the highest rate of screening and randomization. Moving forward, we're hoping to focus on those patients where we think our treatment will be most appropriate in real life.

Cory Kasimov -- J.P. Morgan -- Analyst

Okay. Thank you.

Operator

Thank you. Our next question comes from Yang Wang with Bank of America Merrill Lynch. Your line is open.

Qian Wang -- Bank of America Merrill Lynch -- Analyst

Hi, good morning. Thanks for taking my questions as well. I have one for Ozanimod. So, when you talk about 1Q 19 resubmission, can you elaborate which one is the gating study? Is it a two-year [inaudible] studying animals because that takes, obviously, longer or do you have any other considerations about that? Then quickly follow up to the last question on UC -- the completion of the enrollment has been slipping a couple of times. How confident are you that you will be able to complete the enrollment next year? Lastly, on the impact NDA -- have you engaged FDA about the submission for Fedratinib? Is it going to be second line, for sure, and whether the study will satisfy that requirement? Thank you.

Jay Backstrom, MD -- Chief Medical Officer

So, with respect to what we mean by Q1, it was reflected in my comments, bringing back to non-clinical programs in the additional clin-pharm work is under way.

Terrie Currant -- President, Inflammation and Immunology

I think in terms of the timing of TRUE NORTH, we've done some with deep analysis looking at some of the recruitment rates and the activities that we've implemented. So, I would think the timing we've just indicated is on the conservative side.

Nadim Ahmed -- President, Hematology and Oncology 

Maybe -- this is Nadim here -- thanks for the question. I'll pick up the question on Fedratinib and NDA submission. Remember, we had the acquisition. So, previously, it was Impact Biomedicines that was doing the interactions with FDA. We, of course, have our own meetings planned with the FDA and we'll make sure we follow the FDA later this year as Mark said earlier on.

Qian Wang -- Bank of America Merrill Lynch -- Analyst

Great. Thank you very much.

Operator

Thank you. Our next question comes from Ronny Gal from Bernstein. Your line is open.

Ronny Gal -- Bernstein -- Managing Director

Good morning, everybody. Thank you for taking my question. Since it was not said yet, congratulations on the strong quarterly results. I have two, none of them on Ozanimod. The first one in Otezla -- first of all, congratulations again, obviously, you were early in finding your path into the preferred product place. We are now seeing Cosentyx and Taltz engage in a bit of a price war to try to get a position on the preferred list. Does that essentially mean you're already there or does that mean you'll either have to take a little bit of a price cut or face a less favorable position?

And the for Nadim, CC480 you're putting into the clinic, how does this differ from other cell mod? Are you looking at this as a treatment for primarily for folks with poor prognostic or can this, with the new MRD negativity optionality be used as a potential competitor to the image on a future development path?

Terrie Currant -- President, Inflammation and Immunology

Thanks for the question. Just regarding Otezla and the formulary list, we did a lot of work in 2017 with managed care. It was very important for us to contract with those plans. We're heading in to '18 in a really solid position having contracted with over 80% of the commercial lines. Importantly, we're getting earlier in the treatment paradigm. So, our source of business is coming from topical, pre-biologic patients. So, the competitors in terms of the space, they're really kind of playing in that post-biologic segment. So, heading into '18, we see the GTN impact to be really minimal.

Ronny Gal -- Bernstein -- Managing Director

Thank you.

Rupert Vessey -- President, Research and Early Development

Hi, this is Rupert Vessey here, Research and Early Development -- regarding CC92480, we're very excited about this molecule, but I would strongly encourage all of you on the phone to go to our myeloma deep dive research day where we'll be presenting for the first time some of the discovery and early development features of this novel cell mod. Thanks.

Operator

Thank you. Our next question comes from Michael Yee from Jefferies. Your line is open.

Michael Yee -- Jefferies -- Analyst

Thanks. Congrats. I also will not ask an Ozanimod question. Two parts -- one is Luspatercept data is coming up imminently. Maybe you can talk to your expectations here and what is clinically meaningful data since that's an important partnership you did and I think it's guidance. The second is Juno JCAR017 data is expected. Can you just remind us if you fully expect that this year and which part of differentiation would you expect versus Yescarta and talk to your confidence around that? Thanks so much.

Jay Backstrom, MD -- Chief Medical Officer

Yeah. Hi, this is Jay. The Luspatercept program, as we've discussed earlier had accrued beautifully. We're waiting for that final time point, which gets us mid-year. The way those protocols were designed in terms of the overall response and ability of the transfusion independence for the MDS, we believe that should be meaningful and really an important contribution for treatment, assuming, in fact, our results play out the way we anticipate.

Nadim Ahmed -- President, Hematology and Oncology 

For JCAR017, we mentioned we completed enrollment for TRANSCEND US at the end of the first quarter. So, I think we'll continue to follow those data. Of course, we mentioned we have an oral presentation at ASCO, which will be the early part of that study, the dose escalation and dose expansion cohort.

And then as the core patient population used for the pivotal study and subsequent submission, we'll continue to follow those data and present them at the right time. In terms of differentiation, we are still seeing favorable safety profile relative to the other assets out there. We'll continue to follow up for efficacy also and update you as we glean those data. Thanks for the question.

Operator

Thank you. Our next question comes from Salim Syed from Mizuho. Your line is open.

Salim Syed -- Mizuho -- Managing Director

Yeah. Thanks for taking the questions, guys. I guess the flow here is multiple questions is OK, so, if I may -- one on Fedtratinib, Mark and Nadim, you both emphasized that you plan on filing later this year. I think the previous guide there was mid-year. So, maybe if you could comment about what's going on with Fedratinib FDA submission. Two, just on the litigation front with Revlimid -- do you view the filers beyond Reddy's as prominent filers or is Dr. Reddy's really the last filers we should be thinking about as substantial? Then the last one, Mark, if you could give us your thoughts on Trump's speech on May 8th, what should we be looking out for there?

Nadim Ahmed -- President, Hematology and Oncology 

Hey, Salim, I'll pick up the Fedtratinib question. Going back to what I said earlier, we still plan to file the NDA later this year, as we said. We want to make sure we have our own engagement with the FDA and have a good discussion. That's the only reason that I'm characterizing it that way. We need to have that sit down discussion with the FDA. But again, we plan to file the NDA this year.

Mark Alles -- Chairman and Chief Executive Officer 

Yeah. Thanks. Of course, I agree with that. On litigation, we take every filer seriously. I don't think there's a prioritization. If filers come along, we will defend our patent state accordingly. Then with respect to the President and the administration, I think that Secretary Azar and FDA Commissioner Gottlieb have bee pretty clear in the last couple of days almost advancing the notion of what the President will likely touch on.

Certainly, we're looking for reinforcement of private sector reforms, maybe certain negotiations from Part D could be crossed over into Part B. I think the Commissioner, FDA Commissioner Gottlieb yesterday really projected the notion that there could be some consideration for revisiting safe harbors in the context of the rebate mechanisms that right now are considered safe harbor between parties. So, it could be as detailed as that.

Then we would fully expect that the President would speak in some way to what he's been talking about off and n and that is the difference between international pricing for pharmaceuticals and US prices. So, I think any or all of those could be part of it. We look forward, as always, to working with the administration, with the FDA, with HHF, what we hope are market-based solutions to access and affordability.

Salim Syed -- Mizuho -- Managing Director

Thank you.

Operator

Thank you. And our next question comes from Alethia Young from Credit Suisse. Your line is open.

Alethia Young -- Credit Suisse -- Analyst

Hey, guys, thanks for taking my question, two of them. I guess Mark and maybe Terrie and the team -- what are some of the key learnings over the past couple years with the I&I business, even as it relates to acquiring assets or competing in a very crowded, aggressive payer commercial environment? How do you apply that going forward from here? Then also on Otezla. Talk a little bit about the impact of the DTC. It seems like every time I turn on the TV I see a commercial. I just want to know if you think that's having a meaningful impact and whether that was a force in what drove the beat there. Thanks.

Terrie Currant -- President, Inflammation and Immunology

So, I'll answer the question on Otezla. I'm glad you've been seeing the ads. We've definitely been putting some investment into that. I think in this category, particularly, when we're trying to focus a patient that is not necessarily on treatment, that's on a topic, ensuring the patient has an idea of what the options are for them is really critical. We kind of measured both the impact on the ads where the patients go to their doctor and request the brand. When we look at our competitive set, the ad really is working in that more than 70% of patients, go to a doctor and ask for a script. It really is having an impact.

Mark Alles -- Chairman and Chief Executive Officer 

Altheia, thanks. Maybe we should all not watch TV, I guess, anymore. On lessons learned, a couple of things I think are important to put Ozanimod and the RTF into some context. It was not that long ago that we would have a conversation about Otezla and the idea that Celgene not being an I&I company or used to the big markets of dermatology, rheumatology, etc., that maybe we should partner Otezla out, maybe we should not build the competencies and capabilities to launch a product like Otezla.

As everyone knows, this has become a very important medicine in a very, very important segment of psoriasis and we hope increasingly in psoriatic arthritis. That was something from zero to 60 in about 2.9 seconds. The company did not have that legacy history. We built it. We hired great people and then we developed a profile of a molecule that today is a blockbuster and doing quite well with a lot of opportunity ahead of it.

I think when we think about the Receptos acquisition and Ozanimod winning, as Jay reviewed again todays so nicely, in two large randomized phase III trials in relapsing MS, the counter to that trial was really outstanding. The work was done in transition from Receptos to Celgene. So, the clinical program so far has been done beautifully by legacy Receptos people and the Celgene clinical operations footprint worldwide.

I think what we learned is that as we become bigger, more complex, as we have a lot of moving parts, there are times where we need to slow down and double and triple check where we are in certain judgements about what we're doing in areas of the company. I think we learned from this is that while we stand behind the decision on benefit risk as Jay talked about to submit the NDA, hindsight view is that the characterization of the metabolite is something we underestimated in the context of FDA's decision.

I wouldn't then associate that with an indictment of our ability to build the company around new therapeutic areas and I certainly wouldn't put that against our ability to license and/or execute our business development strategy, which has been so profoundly strong. During today's call, we talked about Ozanimod being a very, very important drug in relapsing MS on the data. We got questions about Luspatercept. That's our partnership with Acceleron and MDS, Fedtratinib is an acquisition from the start of the year that is NDA ready despite a little bit more time depending on what FDA does tell us what we meet with them.

Then when I think about JCAR017 and our partnership with Juno, we had jumped into cellular immunotherapy with Blue and Juno and here we are now executing on cellular immunotherapy, I think, on a grand scale. So, I would be careful, and we are certainly careful, to not look at aspects of one disappointment or one delay and then apply that to the entire company's ability to continue to be operating at a high level and delivering outstanding results.

We learn things. We think communication is much, much enhanced in the last couple of months. So, if there's a benefit to challenges like this, it gives one pause to reexamine processes and think through everything we're doing so we're as good as we can be. So, I appreciate the opportunity to address that point.

Patrick E. Flanigan III -- Corporate Vice President

I think we have time for two last callers, please.

Operator

Okay. Your next question comes from Carter Gould from UBS. Your line is open.

Carter Gould -- UBS -- Analyst

Good morning, guys. Thanks for taking the questions and Mark, thanks for the comments right there. That's really helpful. I wanted to follow up on the earlier Luspatercept question. I guess for Nadim and Jay, I specifically wanted to get your view on expectations on the safety side in these phase III pivotals relative to the phase II safety sets. Mark, I just want to follow-up on your capacity for your additional sizable yields here, not just in light of $10 billion but also the shake up of the executive management team here and if you need to take a pause and digest things for a bit. Thank you.

Jay Backstrom, MD -- Chief Medical Officer

So, this is Jay. Maybe I'll start with Luspatercept and the safety. The advantage of having phase III trials is you continue to have additional exposure and more opportunity to define that safety profile. To this point to the ongoing assessment monitoring and as you know, for our phase III programs, we have data monitoring committees in place, etc. to give us guidance and advice. We've not seen anything different from the phase II data.

Peter Kellogg -- Chief Financial Officer

Carter, this is Peter. I guess I'll take the question on the M&A from a capacity standpoint and also from a strategic intent. I think we've always had the strategic intent that we want to loo for great time. We view that in our partners. We look for that in anything we acquire. We always want to be on the edge of innovation and where we can make big impact on unmet needs in the medical community and patient community.

In many ways, BD and M&A is just a vehicle through which we access additional great science and innovation that's out there. We talked a lot about it. We are constantly in dialogue with our debt agencies as well as all of our fixed income investors and others to make sure we're really managing our capacity well. As you know, we have very strong cashflow and we have very strong, as you can see today, very strong growth. So, that capacity, in a sense, tends to grow.

Periodically, as you do a larger deal, like we did for Receptos and now we've done for Juno, it does, in a sense, reduce some of that capacity in the short-term, but it grows right back very quickly. I would say that Mark, I think it's fair to say Q1 was a busy quarter. Maybe that's the understatement of the day.

We have done a lot. I think there's a lot of people in the room who are really pulling together here and really executing like crazy. We're very proud of having gone through a tough period here. We've had a couple things we had to work through. We had a lot more to do. We're going to still be looking for opportunities. There's nothing like instantaneously, we never talk about that stuff. We're really going to be motivated by science and the chance to make a difference in that next decade.

Everything will be done in the typical Celgene way, very professionally, very well organized. We did do a lot in the first quarter. If you think about it, if you combine the amount of M&A activity as well as the amount of share repurchases we've done in the last two quarters, I think it's a reasonable investment. I think it's really well-targeted, really valuable initiatives on all sides, including share repurchases and I think we're going to be happy in the near future having done all that.

But I think Mark, as we say, our job is never done. So, we're always kind of on the look. It's not really, "Are we slowing down now?" or anything like that. It's when we really see good science. I think that's what drives us.

Mark Alles -- Chairman and Chief Executive Officer 

Absolutely. That's the story of Celgene for the last 10 or 15 years. It's been reinvesting in building the company through the strategic capacity of the company, the expertise of the company and of course, the strong financial performance, including the first quarter. I would say that the sense of urgency isn't different.

So, we still look for opportunity all the time, even though we were very busy in the first quarter and we have a lot of integration still to go, a lot of things that we want to make sure we're getting right, that doesn't mean we can't continue to look externally or even as Rupert will show on the deep dive, our organic pipeline is starting to come along nicely as well. We're excited about where we are. We're still hungry for opportunities and there are opportunities. But we're still focusing on executing on what we've done.

Maybe just on the structure before we go to another question. Let me take another opportunity to welcome Jennifer Dudinak as the Head of our Global Regulatory Affairs team. She's got tremendous experience across specialty markets, including oncology and certain areas that are key to us. But bringing Jennifer in as a dedicated leader for our regulatory affairs function -- by the way, we were looking for the right period for around about a year. We took our time to find somebody who's a great leader and accomplished in regulatory affairs but fits our culture and management team as well.

An example of something that is slightly different than perhaps the past using Jennifer's hire as an example is the functionality of regulatory affairs is so important that Jennifer was added to the executive committee of the company. This is a committee that I chaired and these are direct reports and other areas of the company that are highly important to our ability to be successful. In the past, that would be something that would be more of an ad hoc nature. We see Jennifer routinely for our discussions about where our portfolio is independent of function.

So, it's a portfolio oversight for the whole company. More and more, we're thinking about how to connect people less from a structure point of view and more from a governance committee point of view and we'll continue to do that. As I said in my prepared remarks, we're looking for other talent and we'll update you as we bring that in. I'll just say this about the marketplace. The Celgene name still travels very well.

Operator

Thank you. We'll take our final question from Laura Chico from Raymond James. Your line is open.

Laura Chico -- Raymond James -- Analyst

Good morning and thank you very much for the question. I'm just wondering if you could follow up on the ex-US Revlimid in pricing. I think you commented that duration for rest of world Revlimid was increasing. I guess where does it stand and where should we be thinking about it at this point relative to duration. And then lastly on pricing trends, ex-US, what should we be expecting near-term, intermediate term that was a bit of a headwind for Pomalyst?

Nadim Ahmed -- President, Hematology and Oncology 

Thanks for the question. Let's start with Pomalyst. What we saw were some of the routine and in some markets have become annual pricing reviews, where the environment outside of the US as well as the US continues to be tough. So, that's what we saw with Pomalyst. The other thing to note with Pomalyst is even when we saw some competitive pressure on volume, much of that was absorbed by a Revlimid-based triplet regimen. So, the company was still getting the credit for that displacement in the marketplace.

In terms of duration, we're still at around 25 to 24 cycles in the US and 14 to 15 cycles ex-US and of course, as we get more approvals in the frontline setting ex-US, we expect that to increase. Thanks for the question.

Peter Kellogg -- Chief Financial Officer

Super. This is Peter Kellogg. I'll just wrap it up. Thank you for joining us. We've run a little bit over and we apologize for that, but we wanted to share with you what we think is a strong start to 2018. You can see it in the numbers. We've tried to be very transparent with everything going on financially with acquisitions and so forth, but also all the different regulatory processes. Great set of questions today.

So, I think everyone for that. We continue to take a strategic focus and a balanced approach to how we drive this business forward. We're strong financially. We're going to continue to really have tremendous focus on the marketplaces where we've got great assets, at the same time building the future through the BD development execution on our pipeline. We certainly recognize the Q1. We wish had a smoother time during Q1 but we've really pulled together and appreciate and thank you for your support. We look forward to having a great year. Thank you for joining us today.

Operator

Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program. You may all disconnect. Everyone have a wonderful day.

Duration: 67 minutes

Call participants:

Mark Alles -- Chairman and Chief Executive Officer 

Peter Kellogg -- Chief Financial Officer

Patrick E. Flanigan III -- Corporate Vice President

Terrie Currant -- President, Inflammation and Immunology

Jay Backstrom, MD -- Chief Medical Officer

Nadim Ahmed -- President, Hematology and Oncology 

Rupert Vessey -- President, Research and Early Development

Geoff Meacham -- Barclays -- Managing Director

Brian Abraham -- RBC Capital Markets -- Analyst

Umer Raffat -- Evercore ISI -- Analyst

Geoffrey Porges -- Leerink Partners -- Managing Director

Robyn Karnauskas -- Citigroup -- Analyst

Cory Kasimov -- J.P. Morgan -- Analyst

Qian Wang -- Bank of America Merrill Lynch -- Analyst

Ronny Gal -- Bernstein -- Managing Director

Michael Yee -- Jefferies -- Analyst

Salim Syed -- Mizuho -- Managing Director

Alethia Young -- Credit Suisse -- Analyst

Carter Gould -- UBS -- Analyst

Laura Chico -- Raymond James -- Analyst

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