Analyst Conference Summary

biotechnology

conference date: March 7, 2020 @ 5:30 AM Pacific Time
for quarter ending: March 31, 2020 (first quarter 2020)

Forward-looking statements

Overview: Revenue up both from Celgene acquisition and on a pro-forma basis.

Basic data (GAAP):

Revenue was $10.78 billion, up 36% sequentially from $7.95 billion and up 82% from $5.92 billion year-earlier.

Net income was negative $775 million, up sequentially from negative $1.1 billion and down from $1.71 billion year-earlier.

EPS (earnings per share), diluted were negative $0.34, up sequentially from negative $0.55, and down from $1.04 year-earlier.

Guidance:

Adjusted GAAP EPS for 2020 to $0.37 to $0.57. Non-GAAP EPS still $6.00 to $6.20. Affirmed 2020 and 2021 non-GAAP EPS guidance.

Conference Highlights:

The Celgene acquisition closed on November 20, 2019, so Q1 is the first full quarter incorporating it. Most revenue increase y/y was due to the acquisition. Pro-forma y/y revenue grew 13%. The quarter benefitted by approximately $500 million due to COVID-19 related buying patterns. GAAP numbers were impacted by expenses related to the Celgene acquisition.

Giovanni Caforio, M.D., CEO of Bristol-Myers Squibb stated "The strength of our financial results and pipeline progress in the first quarter reflect continued successful execution across the company. We are well positioned to continue to successfully drive commercial execution of our inline business, launch new brands, progress our integration efforts and deliver our synergy targets while advancing our pipeline." Seeing some delays in clinical trials, more in new trials than established ones. All stopped trials should resume by year end.

U.S. revenues increased 96% y/y to $6.76 billion. International revenue was up 62% y/y to $4.0 billion.

In January, 2020 announced that the FDA accepted for priority review its sBLA for Opdivo plus Yervoy for the first-line metastatic or recurrent NSCLC with no EGFR or ALK genomic tumor aberrations, with an FDA PDUFA action date of May 15, 2020. In November 2019 announced that the FDA accepted its sBLA and granted Breakthrough Therapy Designation for Opdivo plus Yervoy for the treatment of advanced hepatocellular carcinoma (HCC) previously treated with sorafenib, with a PDUFA of March 10, 2020.

Non-GAAP numbers: diluted EPS $1.72, up 41% sequentially from $1.22 and up 56% from $1.10 year-earlier. Net income $3.96 billion, up 65% sequentially from $2.4 billion, and up 120% from $1.8 billion year-earlier.

Cash and equivalents ended at $19 billion were up sequentially from $16.2 billion. Total debt was $47 billion (avg rate 3.4%). Does not plan an share repurchases in the current environment.

In March 2020 Zeposia (ozanimod) was approved by the FDA for relapsing/remitting multiple sclerosis.

In May 2020, Bristol announced that the FDA extended the action date by three months for the BLA for lisocabtagene maraleucel (liso-cel). The new U.S. FDA action date is November 16, 2020.

In May 2020 the FDA accepted for Priority Review the New Drug Application (NDA) for CC-486 for maintenance treatment of adult patients in remission with acute myeloid leukemia (AML) with an action date of September 3, 2020.

In March, the company and bluebird bio, Inc. announced the submission of their Biologics License Application (BLA) to the U.S. FDA for idecabtagene vicleucel (ide-cel; bb2121), the companies’ lead investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T-cell immunotherapy, for the treatment of adult patients with multiple myeloma who have received at least three prior therapies.

In November 2019, the FDA approved Reblozyl for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell transfusions. In April 2020 the FDA approved Reblozyl for the treatment of anemia in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who have ring sideroblasts and require red blood cell (RBC) transfusions. Reblozyl is licensed from Acceleron.

But in March 2020, Bristol announced negative topline results from ELOQUENT-1, a Phase 3, randomized, open-label trial evaluating the combination of Empliciti (elotuzumab) plus Revlimid (lenalidomide) and dexamethasone (ERd), versus Revlimid and dexamethasone alone (Rd), in patients with newly diagnosed, previously untreated multiple myeloma who are transplant ineligible.

In December, 2019 Bristol announced that the European Commission approved a new indication for Revlimid, in combination with rituximab, for the treatment of previously treated follicular lymphoma.

In December 2019 partner bluebird bio, Inc. announced that KarMMa, a pivotal, open-label, single arm, multicenter, Phase 2 study evaluating ide-cel (bb2121) in patients with R/RMM, met its primary endpoint and key secondary endpoint.

In December, submitted a BLA to the FDA for liso-cel, its autologous anti-CD19 CAR T-cell immunotherapy for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after at least two prior therapies.

Cost of products sold was $3.66 billion. SG&A $1.61 billion. R&D $2.37 billion. Amortization $2.28 billion. Other expense $1.16 billion. Total expenses $11.09 billion. Operating loss $304 million. Tax expense $462 million.

Q&A summary:

CC486 prospects? Got priority review designation. We are excited about it. AML has a poor prognosis. Patients with complete responses, 80% of them relapse. 486 has a 10 month survival benefit, so good commercial potential as a maintenance treatment.

With upcoming launches, strategy? Priority is safety. Engaging remotely. There was a pause, but now some physicians are starting to switch to new therapies or start new patients.

Liso-cel delay? Was granted priorit review in February. They decided one of our responses to a question constituted a major amendment, hence the delay. We remain confident about the data.

Business development continues to be the pillar of our asset strategy. We can continue to bring in new assets going forward.

RCC opportunity? We are excited about the new data. Optivo + Yervoy has remained a standard of first-line care. Market share is between 35% and 40%. We think the new data compares well from TKI monotherapy and combinations. 9ER trial RCC indication once approved will give us a best-in-class offering.

TIGIT program and competition? We look forward to seeing Roche's data. It is a complex mechanism. Then we will see about our program.

In first line lung, physicians are looking at 227 and 9LA together, data will be presented at ASCO. We have a very experiences sales team for the launch. 227 PDUFA is next week, May 15th.

Emerging markets plan? Given our oncology focus, we have focussed on the developing world, but we have a meaningful presence in developing countries. We will continue to invest internationally.

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