Analyst Conference Summary

biotechnology

conference date: April 29, 2021 @ 6:00 AM Pacific Time
for quarter ending: March 31, 2021 (first quarter 2021, Q1)

Forward-looking statements

Overview: Trudging along.

Basic data (GAAP):

Revenue was $11.1 billion, near flat sequentially from $11.1 billion and up 3% from $10.8 billion year-earlier.

Net income was $2.0 billion, up sequentially from negative $10.0 billion and up from negative $0.78 billion year-earlier.

EPS (earnings per share), diluted were $0.89, up sequentially from negative $4.45, and up from negative $0.34 year-earlier.

Guidance:

Updating 2021 guidance slightly higher to GAAP EPS $3.18 to $3.38, non-GAAP to $7.35 to $7.55.

Conference Highlights:

The Celgene acquisition closed on November 20, 2019, so Q1 2021 is the first quarter where y/y increase in revenue is not inflated by that.

Giovanni Caforio, M.D., CEO of Bristol-Myers Squibb stated "We continue to deliver solid growth, execute against our strategic priorities and make meaningful progress across our pipeline."

U.S. revenues increased 4% y/y to $7.01 billion. Ex-US revenue was up 3% y/y to $4.0 billion.

Longer term financial expectations for 2020 to 2025 are low to mid-single digit annual revenue growth; $3 billion of synergies by 2022 (from Celgene acquisition); $45 to $50 billion in free cash flow from 2021 to 2023. That leaves strength for potential business development deals. The current launch portfolio has $20 to $25 billion in NRA revenue potential in 2029.

Breyanzi and Abecma cell therapies approved in Q1 are seeing good interest from physicians.

Non-GAAP numbers: diluted EPS $1.74, up 19% sequentially from $1.46 and up 1% from $1.72 year-earlier. Net income $4.0 billion, up 20% sequentially from $3.33 billion, and flat from $4.0 billion year-earlier.

Cash and equivalents ended at $11.0 billion were down sequentially from $16 billion. Long-term debt was $44.5 billion (avg rate 3.4%). $1.8 billion used for stock repurchases.

In February, 2021 Bristol announced results from POETYK PSO-2, the second Phase 3 trial evaluating deucravacitinib for the treatment of patients with moderate to severe plaque psoriasis. POETYK PSO-2 met both co-primary endpoints. In November 2020, announced positive results from the Phase 3 POETYK PSO-1 trial evaluating deucravacitinib, a selective tyrosine kinase 2 (TYK2) inhibitor, for the treatment of patients with moderate to severe plaque psoriasis. POETYK-PSO-1 met both co-primary endpoints evaluating deucravacitinib versus placebo on the Psoriasis Area and Severity Index (PASI 75) and Physician Global Assessment (sPGA) scales and met multiple key secondary endpoints versus Otezla (apremilast). Believes should be the best oral option for psoriasis. In Phase 2 for psoriatic arthritis, lupus, crohn's, ulcerative colitis.

In October 2020, the company and Exelixis announced the FDA accepted the sBLAs, respectively, for Opdivo(nivolumab) in combination with Cabometyx (cabozantinib) for patients with advanced renal cell carcinoma (RCC). The PDUFA goal date is February 20, 2021.

In Q1 2021 announced Licensing Agreement with The Rockefeller University for SARS-CoV-2 Neutralizing Monoclonal Antibody Combination for the Treatment of COVID-19.

In January 2021, Bristol announced that the FDA) approved Opdivo (nivolumab) in combination with Cabometyx (cabozantinib), for the first-line treatment of patients with advanced renal cell carcinoma. The FDA and EMA also accepted the sBLAs for patients with advanced or metastatic gastric cancer. In November 2020 the EMA had approved Opdivo for esophageal squamous cell carcinoma. Also got EMA approval for Opdivo plus Yervoy for certain NSCLCs.

In July resubmitted liso-cel BLA. 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 March, the company and bluebird bio had announced the submission of their Biologics License Application (BLA) to the U.S. FDA for idecabtagene vicleucel (ide-cel; bb2121), the 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 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.

Cost of products sold was $2.84 billion. SG&A $1.67 billion. R&D $2.23 billion. Amortization $2.51 billion. Other income $0.70 billion. Total expenses $8.54 billion. Operating profit $2.53 billion. Tax expense $501 million.

Q&A summary:

Factor XIa trials? If we can produce another agent for clotting improvement, with a better safety profile, that would be the goal. This is a space we know extemely well.

Opdivo new indication ramps? We are excited about the esophageal opportunity, we think we can drive treatment rates over time, bladder cancer as well.

LAG3 (Relatlimab)? We are very excited with the Phase 3 data readout. Enhancing activity on top of Opdivo for first-line melanoma. Natural progression is to adjuvant setting, we will be doing a Phase 3 program for that. NSCLC could see a Phase 3 program started by the end of the year.

PD-1 longer term view on price competition? We look at this a lot. We are very competitive. The risk of commoditization would require an interchangeable, low cost entrant, which we don't see so far, but may happen in some regional markets. We have an extremely broad data set to point too and continue to bring new indications to market.

Rebolzyl expectations? Sequentially relatively flat as new patients declined due to the pandemic. Bolus patients are declining. But seeing new patient starts, expectations for 2021 have not changed.

With Onureg we are creating a market, it is going well but will take some time, customers like the efficacy data. The cell therapy products have been well received, over 50 accounts have been activated.

SEC noise about consolidation is anti-competitive? Business development is an important part of our strategy. When we acquire assets we accelerate their development, creating value for patients. We think we can continue to strengthen our portfolio. We don't see anti-competitive measures as limiting us at this point.

Too early to guess at government potential changes. We have a broad portfolio in terms of both product and payers. The priority should be lower costs for end customers, including in Part D.

Zeposia sales drivers? We are excited about the MS oportunity because of its profile. We are launching well in the U.S., just beginning in EU. UC (ulcerative colitis) launch will be important in 2022 and beyond.

816 commercial opportunity? Happy with data so far. It is a sizeable opportunity with about 30,000 patients. Once there is a more active treatment more patients are likely to identify.

OpenIcon Analyst Conference Summaries Main Page

Search

More Analyst Conference Pages: