Bristol-Myers Squibb Company

Myers Skip 2022 First Quarter Results Conference Call. Today's conference is being recorded. At this time, I would like to turn the conference over to Mr. Tim Power, Vice President, Investor Relations. Please go ahead, sir.

Thank you, Sergey, and good morning, everyone. Thanks for joining us this morning for our first quarter 2022 earnings call. Joining me this morning with prepared remarks are Giovanni Caporia, our Board Chair and Chief Executive Officer, and David Elkins, our Chief Financial Officer. Also participating in today's call are Chris Berner, our Chief Commercialization Officer, and Salman Hirawat, our Chief Medical Officer and Head of Global Drug Development. As you'll note, we've posted slides to bms.com that you can follow along with for Giovanni and David's remarks. But before we get started, I'll read our forward-looking statement. During this call, we'll make statements about the company's future plans and prospects that constitute forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors including those discussed in the company's SEC filings. These forward-looking statements represent our estimates as of today and should not be relied upon as representing our estimates as of any future date. We specifically disclaim any obligation to update forward-looking statements, even if our estimates change. We'll also focus our comments on our non-GAAP financial measures, which are adjusted to exclude certain specified items. Reconciliations of certain non-GAAP financial measures to the most comparable GAAP measures are available on BMS.com. And so I'll hand over now to Giovanni.

Thank you, Tim, and good morning, everyone. Let's start with our first quarter performance on slide four. This is an important year for Bristol-Myers Squibb, and I'm pleased to share that we've had a strong start to 2022. In fact, just yesterday, the FDA approved Mavacam10, or Camxios. This is a first-in-class medicine for patients living with symptomatic obstructive HCM. It's an important milestone for patients who, up until now, had no options to treat the underlying cause of this disease. I'm proud that we're giving hope to patients and improving their quality of life. It's also an important milestone for BMS. With U.S. approvals of Obdulag and Canxios so far this year, we have significantly strengthened our new product portfolio. and we are on track to potentially launch three important new first-in-class medicines this year. Additionally, strong commercial execution in the quarter resulted in solid year-over-year growth from our inline products and new product portfolio. During the quarter, we saw the first entries of Revlimid generics in the U.S. and Europe. David will comment on our first-quarter dynamics, but for the full year, U.S. entry expectations remain the same, while ex-U.S. erosion is expected to be faster than previously anticipated. Overall, we grew revenue by 5% and delivered double-digit, non-gap EPS growth compared to the same quarter last year. There is good momentum in our business, and our performance in Q1 validates that we are well-prepared for the renewal of our portfolio. with multiple catalysts across in-line products and new product portfolio to more than offset upcoming LOEs and drive growth through the decade. Our very strong financial position gives us significant flexibility as we continue to prioritize business development while paying down debt and expanding shareholder distributions. Let me turn to our scorecard on slide five and provide some context around the important achievements of the quarter. We are making good progress against our milestones, which are central to delivering on our long-term strategy and growth as a company. Starting with the milestones we saw during the quarter, Opdivo was approved in the US in March as the first IO agent to treat early stage non-small cell lung cancer patients before surgery. This indication strengthens its profile in lung and provides additional tailwind for growth. While disappointed with the results of the BankPak program, we are very pleased with the significant progress of our new product portfolio overall. Brianzi is now approved in Europe, our second CAR-T cell therapy approved in the EU. As you know, We've been planning to bring three important new products to market this year. So far, two of those new products, Obdualag and Camzias, received FDA approval. Many of our new products have significant expansion opportunities. For Obdualag, we recently initiated a pivotal study in colorectal cancer. And for Ducravacidinib, we delivered a successful phase two proof of concept result in lupus. Looking to the future, the breadth of milestones ahead is exciting. One that we're looking forward to is the Milvexian Phase II data in secondary stroke prevention. We have decades of expertise in cardiovascular disease, and we believe this could be a medicine that treats an even broader population of patients than current oral anticoagulants. We expect to get Phase II data in-house around the middle of the year, And depending on the results, we plan to start phase three trials later this year. Turning to our three new products on slide six. As I mentioned, in March we received approval for Obdualag for the treatment of patients with unreceptable or metastatic melanoma. Obdualag is our first in class fixed dose dual immunotherapy combination of nivolumab and the lag-free blocking agent antibody, relatlimab. The combination of relatlimab and nivolumab demonstrated a clinically meaningful PFS-NOS benefit. Obdualac marks the second approved I-O combination that we've delivered and demonstrates our continued scientific leadership in I-O. While we are still in the early days, I can say that the Obdualac launch is going very well. We believe this medicine has the opportunity to become a new standard of care for melanoma patients. In addition to melanoma, OVDUALAG has the potential for new indications, and we are exploring important opportunities in lung, liver, and colorectal cancers. Turning now to our just FDA-approved Mavacamptan, or Camzius. The benefit of Camzius for patients with symptomatic obstructive HCM were further reinforced with the exciting Valor data presented at ACC this month. We're launching CanXios in the U.S. and look forward to receiving EU approval and launching internationally with future indications to come. Finally, we continue to be excited about the opportunity for Ducravacidinib. As you know, we have an FDA PDUFA date in September for psoriasis. We believe that psoriasis patients need better oral options, and this asset has demonstrated superior efficacy compared to the oral standard of care with a favorable safety and tolerability profile. During the first quarter, we also delivered a successful Phase II proof of concept result in lupus, positioning us to start Phase III studies later this year in a disease with a very high unmet need. Importantly, The lupus data continues to show the consistent and differentiated safety profile of a selective TIK2 inhibitor. We plan to share comprehensive data with the scientific community at an upcoming Congress this year. With our upcoming FDA PDUFA date in the third quarter, phase C trials already underway in psoriatic arthritis, and a proof of concept achieved in lupus, and additional phase two trials ongoing, including in IBD, our confidence in the potential of this program continues to grow. Now, turning to slide seven. Thanks to the hard work, dedication, and strong execution by our employees, I am confident in our ability to deliver on our strategy and more than offset key LOEs by continuing the growth of our inline products with 8 to 10 billion in incremental sales and delivering 10 to 13 billion of revenue expected from our new product portfolio by 2025. Our strong clinical performance further de-risks our launch portfolio. And as a result, we have confidence in our ability to deliver the 25 billion plus in non-risk adjusted revenue in 2029. We have a strong foundation in place, and as the renewal of our portfolio gains further traction this year, I am confident in the potential of our company.