Analyst Conference Summary

biotechnology

conference date: February 2, 2023 @ 6:00 AM Pacific Time
for quarter ending: December 31, 2022 (fourth quarter 2022, Q4)

Forward-looking statements

Overview: Appears stagnant, but new therapies prepping for expansion as decade progresses.

Basic data (GAAP):

Revenue was $11.41 billion, up 2% sequentially from $11.22 billion and down 1% from $11.99 billion year-earlier.

Net income was $2.02 billion, up 25% sequentially from $1.61 billion and down 15% from $2.37 billion year-earlier.

EPS (earnings per share), diluted were $0.95, up 27% sequentially from $0.75, and down 11% from $1.07 year-earlier.

Guidance:

For the full year 2023 rexpects sales up 2% y/y. Diluted GAAP EPS $4.03 to $4.33. Non-GAAP EPS $7.95 to $8.25. For full year 2025 sees possibly $10 to $13 billion in sales, then $25 billion in 2030. [see slide 6]

Conference Highlights:

Giovanni Caforio, M.D., CEO of Bristol-Myers Squibb stated "We are especially proud to have launched three first-in-class medicines that address serious unmet medical needs for patients. Our financial strength, talented workforce and proven ability to execute will enable us to continue to progress our pipeline and invest in future sources of innovation. With a younger and more diversified portfolio, promising mid-to-late stage registrational assets and a deep early-stage pipeline, I am confident that the company is well positioned for multiple waves of innovation that will support long-term growth." Expects to grow both revenue and non-GAAP earnings in 2023, sees growth through 2030. But pricing environment is increasinlgy complex.

Plans to launch repotrectinib, acquired with Turning Point Therapeutics, an ROS1/NTRK inhibitor for NSCLC, in 2H 2023.

Both GAAP and Non-GAAP numbers include a negative $0.24 per share impact due to acquired IPRD Charges and Licensing Income in Q4 2022.

In Q3 2022 the FDA has accepted a supplemental new drug application for Camzyos (mavacamten) for an expanded indication for the treatment of adults with symptomatic New York Heart Association class II-III obstructive hypertrophic cardiomyopathy and assigned a PDUFA goal date of June 16, 2023. Camzyos for symptomatic obstructive hypertrophic cardiomyopathy was approved by the FDA in April 2022.

In Q3 2022 milvexian in secondary stroke prevention had positive Phase 2 data, a 30% reduction of strokes. Phase 3 trial is being prepared.

Bristol received a positive CHMP opinion for Sotyktu in January 2023.

Remains committed to growing the dividend.

In Q4 2022 Reblozyl received a CHMP approval for anemia from non-transfusion dependent beta thalassemia; in global collaboration with Merck. Japan approved Breyanzi for large B-cell lymphoma, while Phase 2 data for CLL and SLL were positive.

Beginning with the first quarter of 2022, significant R&D charges or other income resulting from upfront or contingent milestone payments in connection with asset acquisitions or licensing of third-party intellectual property rights are no longer excluded from non-GAAP results.

Non-GAAP numbers: diluted EPS $1.82, down 9% sequentially from $1.99 and down 1% from $1.84 year-earlier. Net income $3.9 billion, down 8% sequentially from $4.26 billion, and flat from $ billion year-earlier.

Cash and equivalents ended at $9.25 billion up sequentially from $9.02 billion. Cash flow from operations $3.3 billion. Long-term debt was $35.1 billion (avg rate %). $0 billion used for stock repurchases, but $9.5 billion remains authorized. Paid down $5 billion of debt in 2022.

In Q3 the FDA approved Sotyktu (Deucravacitinib), a first-in-class TYK2 inhibitor ofr adults with moderate to severe plaque psoriasis. Japan also accepted an NDA for deucravacitinib for the treatment of adults with moderate to severe plaque psoriasis, pustular psoriasis and erythrodermic psoriasis.

The mid to late stage pipeline includes repotrectinib, farletuzumab exteribulin, AR-LDD, iberomide, mezigdomide, alnuctamab BCMA TCE, CC-99282, cendakimab, LPA1, and milvexian.

Cost of products sold was $2.59 billion. SG&A $2.27 billion. R&D $2.51 billion. Amortization $2.34 billion. Acquired IPRD $52 million. Other income $217 million. Total expenses $9.55 billion. Operating profit $1.86 billion. Tax benefit $166 million.

Full Year 2022 revenue was $46.2 billion, down from $46.4 billion in 2021. GAAP EPS was $2.95, non-GAAP EPS $7.70. GAAP Net income$6.33 billion.

Q&A selective summary:

Tik2 positioning? Sotyktu performance very good so far. Over 2000 scripts. Market share 35% for new product in its category. We are working with payers on access. Impact of Humira biosimilars does not change our Sotyktu strategy.

Camzyos launch? Seeing acceleration of patient and physician dydnamics. Over 1,800 patients prescribed, converting over to commercial drug. Very strong positive feedback. Targetting 500 accounts nationally representing 60% of U.S. patients.

Sotyktu hurdles? We don't see the Otezla going into the mild market as a problem. Seeing desire to use in full spectrum of our label, including moderate, because the studies show superiority to Otezla.

IRA drug negotiations? Patent expirations? Eliquist? Still many unknowns as CMS works through their process. We do not expect IRA to impact us until 2026. It is possible Eliquist will be impacted in 2026. We split Eliquist profit with Pfizer. We expect to grow through IRA by introducing new medicines. Reinforces need for strong commercial execution, including rapid transitions from free to paid drugs.

Abecma, other cell-therapy capacity? We expect capacity to continue to expand in 2023. Three-fold strategy: success rates; vector supply; drug product site expansion.

R&D spend? That is driven by our portfolio. Several programs completed. Low single digit decline in overall operating expenses. Growing the topline will allow for strong R&D effort.

Reblozyl duration growth, label expansion timeline? Good new patient acquisition. But most growth would be from increased duration of therapy. No timeline yet on new data or filing.

Atopic dermatitis has several therapies on the market, so we are not pursuing it for ???, though we continue to develop for other indications.

Revlemid sales beyond 2023? No change in outlook through 2025. Expect about a $2.5 billion step down each year in 2024 and 2025.

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