Analyst Conference Summary

biotechnology

conference date: February 4, 2022 @ 5:00 AM Pacific Time
for quarter ending: December 31, 2021 (fourth quarter 2021, Q4)

Forward-looking statements

Overview: Good quarter

Basic data (GAAP):

Revenue was $12.0 billion, up 3% sequentially from $11.6 billion and up 8% from $11.1 billion year-earlier.

Net income was $2.37 billion, up 53% sequentially from $1.55 billion and up from negative $10.0 billion year-earlier.

EPS (earnings per share), diluted were $1.07, up 55% sequentially from $0.69, and up from negative $4.45 year-earlier.

Guidance:

For the full year 2022 expects sales about $47.0 billion. GAAP EPS $3.37 to $3.67; non-GAAP EPS $7.65 to $7.95.

Conference Highlights:

Giovanni Caforio, M.D., CEO of Bristol-Myers Squibb stated "2021 was a pivotal year for our company as we achieved significant regulatory and clinical milestones and positioned the company to successfully renew our portfolio. I am confident in our ability to execute against our key milestones in 2022, including three planned first-in-class launches with relatlimab plus nivolumab fixed dose combination, mavacamten and deucravacitinib." New business sales are more than offsetting impact of generic competition in older drugs. Believes this trend will continue for the decade, accelerating in 2025 to 2029.

In February 2022 announced a $15 billion share repurchase program, including $5 billion in Q1.

The FDA in December 2021 approved Orencia for graft versus host disease.

In November, the FDA extended the review of the NDA for mavacamten for the treatment of patients with symptomatic obstructive hypertrophic cardiomyopathy to April 28, 2022 to allow for an update to the Risk Evaluation Mitigation Stragegy.

In January 2022, the CHMP in the EU recommended approval of Breyanzi (lisocabtagene maraleucel) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B after at least two prior therapies

In Q4 2022 data from the Phase 2 AXIOMATIC-TKR trial that showed milvexian reduced the risk of postoperative venous thromboembolism in a dose dependent manner without increasing the risk of bleeding compared with enoxaparin in patients undergoing total knee replacement surgery.

In Q4 2021 the FDA accepted the NDA and the EMA validated the Marketing Authorization Application for deucravacitinib for the treatment of adults with moderate to severe plaque psoriasis. The FDA assigned a PDUFA goal date of September 10, 2022. Japan also accepted the NDA for deucravacitinib for the treatment of adults with moderate to severe plaque psoriasis, pustular psoriasis and erythrodermic psoriasis.

In January 2022, the Bristol and Century Therapeutics announced a research collaboration and license agreement to develop and commercialize up to four induced pluripotent stem cell derived, engineered natural killer cell or T cell programs for hematologic malignancies and solid tumors.

Non-GAAP numbers: diluted EPS $1.83, down 8% sequentially from $2.00 and up 25% from $1.46 year-earlier. Net income $4.1 billion, down 9% sequentially from $4.5 billion, and up 24% from $3.3 billion year-earlier.

Cash and equivalents ended at $17.0 billion up sequentially from $15.7 billion. Total debt was $44.6 billion (avg rate 3.4%). $ billion used for stock repurchases. In 2021 debt was reduced by $6.1 billion.

In November 2022, the Phase 3 CheckMate 816 trial met the co-primary endpoint of improved event-free survival (EFS) in patients with resectable Stage IB to IIIA non-small cell lung cancer.

In October 2021 the EMA approved mavacamten for obstructive hypertrophic cardiomyopathy. Also Opdivo was approved in combination for first-line HER2-negative gastric, gastroesophageal junction, esophageal adenoccarcinoma expessing PD-L1.

In September 2021 the FDA gave a PDUFA date of May 28, 2022 for Opdivo for esophageal squamous cell carcinoma (ESCC). In July, the EC had approved Opdivo for the adjuvant esophageal or GEJ cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy. In August gave approval for Opdivo for adjuvant urothelial carcinoma.

The FDA assigned a PDUFA goal date of March 19, 2022 for the relatlimab and nivolumab fixed-dose combination for unresectable or metastatic melanoma.

The CHMP of the EMA in October 2021 recommended approval of Zeposia for moderate to severe ulcerative colitis.

At ASCO presented Phase 2/3 data for relatlimab, a LAG-3 antibody, and nivolumab, showing positive PFS compared to Opdivo for melanoma.

In January 2022, the CHMP in the EU recommended approval of Breyanzi (lisocabtagene maraleucel) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B after at least two prior therapies

In December 2022 the FDA accepted for priority review the supplemental Biologics License Application for Reblozyl for the treatment of anemia in adults with non-transfusion dependent beta thalassemia. PDUFA goal date is March 27, 2022. The EMA also validated the Type II variation for Reblozyl for NTD beta thalassemia. The applications are based on results from the Phase 2 BEYOND trial.

In December 2021 at ASH, data from the Phase 3 TRANSFORM trial, showed Breyanzi significantly improved EFS compared to chemotherapy plus autologous stem cell transplant as second line treatment in adults with relapsed or refractory large B-cell lymphoma.

In September 2021, the Court of Appeals for the Federal Circuit affirmed the U.S. District Court's August 2020 decision finding the composition of matter patent US 6,967,208 and formulation patent US 9,326,945 covering Eliquis valid and infringed. The earliest that generic manufacturers are permitted to launch their generic apixaban products is April 1, 2028, subject to additional appeals and challenges.

Cost of products sold was $2.36 billion. SG&A $2.35 billion. R&D $2.60 billion. Amortization $2.42 billion. Other income $393 million. Total expenses $10.1 billion. Operating profit $1.86 billion. Tax benefit $514 million.

For the full year 2021 revenue was $46.4 billion, GAAP net income $7.01 billion, diluted EPS $3.12. Non-GAAP EPS was $7.51.

Q&A summary:

Factor XI timing, competition and expectations? Second Phase 2 study data should be available mid-year to us, then will release at a conference. Goal is to isolate the impact on the bleed v. the background therapies. Then will progress to the appropriate indications.

Mavacampten v. competitors? We are launch ready, PDUFA is soon. We don't see any differentiated competition on the horizon.

Mavacampten launch dynamics? We see it as a gradual launch, stepwise. Initial strong interest in treating severe patients at centers of excellence. Will be more gradual with cardiologists, we will have an educational effort. We feel very good about the long term potential.

CAR T capacity? Supply constraints are related to the vector. Mid year we could be in a better position. Breyanzi support should be ready by the time we get label expansions. We have seen no access (remimbursement) constraints.

Zeposia? We feel good about access for MS. For UC we will need a diligent campaign around access.

LAG3 and TIGIT? Pleased with potential to launch relatlimab (a LAG3 antibody). We see it as going after the third of the market that is currently single agent PD1 therapy for melanoma.

Low cost PD1 competition? We are not seeing Physicians switching so far, given the depth of our data, we see them impacting only the smaller markets so far.

Mavacampten $4 billion figure, how realistic is the 3x diagnosis rate part? It is a defined patient market, 80,000 to 90,000 in U.S., same ex-U.S. We see it possible to double the current diagnosis rate. The majority of the potential is in obstructive disease.

Risks to Revlimid sales projection in 2022? We felt is was importance to provide guidance for the year. As generics enter could be quarter to quarter variability. First entry is in March. Remainder likely to come in around September. We are confidence in the guidance we provided ($9.5 to $10 billion).

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