Analyst Conference Summary

biotechnology

conference date: February 6, 2024 @ 5:00 AM Pacific Time
for quarter ending: December 30, 2024 (first quarter 2024, Q4)

Forward-looking statements

Overview: Strong revenue growth, but guided low for 2025. IRPD charges hit GAAP earnings.

Basic data (GAAP):

Revenue was $12.3 billion, up 3% sequentially from $11.9 billion and up 8% from $11.5 billion year-earlier.

Net income was $72 million, down 94% sequentially from $1.21 billion and down 96% from $1.8 billion year-earlier.

EPS (earnings per share), diluted were $0.04, down 93% sequentially from $0.60, and down 95% from $0.87 year-earlier.

Guidance:

Full year 2025 non-GAAP revenue around $45.5 billion due to impact of generic competition. Gross Margin 72%. Op ex $16 billion, other income $30 million. 18% tax rate. Resulting in diluted EPS of $6.55 to $6.85.

Conference Highlights:

Chris Boerner, CEO, said "We made good progress in 2024, which was capped by a fourth quarter of strong topline growth driven by key products and important pipeline advancements. We also achieved the landmark U.S. approval of Cobenfy last year for the treatment of schizophrenia in adults, and we expect this medicine to have a meaningful impact on patients and the company as a new growth driver. Our collective focus on execution has established a solid foundation to navigate the multi-year journey toward achieving top-tier sustainable growth and long-term shareholder returns." The strategic productivity initiative is being expanded to generate about $2 billion in additional annual cost savings by end of 2027. Initiating 7 Phase 3 studies in 2025.

Cobenfy (KarXT), a first-in-classs M1/M4 agonist for schizophrenia was approved by the FDA in September 2024. First new drug for schizophrenia in decades. Prepping trials in other indications. With this Bristol is re-establishing its presence in neuroscience. Launch began in October 2024.

The FDA approved subcutaneous nivolomab (Opdivo Qvantig) with hyaluronidase combo for solid tumors post Opdivo+Yervoy combo therapy in December 2024. In first line unresectable hepatocellular carcinoma set PDUFA of April 21, 2025. In Europe in Q4 2024 the CHMP recommended approval of Opdivo + Yervoy for first-line unresectable or advanced hepatocellular carcinoma. The EC approved the combo for microsatellite instability-high metastatic colorectal cancer (mCRC).

Most new drugs sold well, but generic competition had a negative impact on sales of Sprycel, Revlimid,Abraxane and Pomalyst. Eliquis is expected to have tempered Q1 y/y sales growth due to Medicare Part D redesing, but then pick up in 2H from elimination of the coverage gap.

In Q1 2025 the EC approved Augtyro for ROS1-positive advanced NSCLC and also for advanced solid tumors expressing NTRK gene fusion.

In Q1 2025 Sotyktu (deucravacitinib) Phase 3 results for psoriatic arthritis were positive.

Non-GAAP numbers: diluted EPS $1.67, down 7% sequentially from $1.80 and down 2% from $1.70 year-earlier. Net income $3.4 billion, down 8% sequentially from $3.7 billion, and down 3% from $3.5 billion year-earlier.

Cash and equivalents ended at $11.2 billion up sequentially from $8.42 billion. Cash flow from operations $4.4 billion. Long-term debt was $ 47.6 billion, short term $2.0 billion. $0 billion used for stock repurchases, but $5 billion remains authorized. Plans to pay down $4 billion of debt in 2025/2026; paid down $6 billion in 2024.

US revenue increased 9% to $8.60 billion; international up 5% to $3.75 billion.

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 $4.81 billion. SG&A $2.14 billion. R&D $3.19 billion. Amortization of acquired intangible assets $1.69 billion. Acquired IRPD $30 million. Other expense $305 million. Total expenses $12.2 billion. Operating profit $175 million. Tax $99 million.

Q&A selective summary:

Cobenfy ramp? Strong start, now at 1,000 presciptions per week. Access going well with Medicare, Medicaid, making progess with commercial carriers. 30,000 psychiatrists to educate and break old prescibing assets. Expects major ramp in 2H 2025.

Cost program? Focus is on investing for growth. Cost program in 2024 helped us become more agile. Good position going forward, will continue to look to cut costs while keeping the organization right-sized.

For full year we expect strong double-digit y/y growth for Eliquis, but will reverse old pattern, so 2H will be stronger than 1H and Q1 may be particularly slow.

Kennedy effect? Will work cooperatively with both parties and RFK if confirmed. We want the FDA to have what it needs for its mission. IRA price-setting law does need aspects fixed.

Does not expect new competitors with the mechanism of action of Cobenfy until 2026 or 2027. Current market is 80% generics.

We have potential to read out up to 15 registrational trials by the end of next year. We have had several successes in accelerating timelines for trials.

Differences with analyst prior concensus for guidance? Repeated short-term impacts of generic competitors. Believes the $500 million foreign currency headwind is the main difference in guidance estimates. Our focus is on significantly faster growth as we exit the decade.

Iberdomide program? MRD is becoming a more important endpoint for multiple myeloma. Believes will be a primary endpoint in the trial, discussing with FDA. CFS will be followed, but not a primary endpoint. With data will engage authorities about path forward.

Business development? A top priority, both for acquisitions and specific assets. Financials need to make sense. We are in a strong financial position, so we have flexibility.

We are getting very positive patient and doctor feedback on Cobenfy, even in the first week of dosing. Most are starting at the lowest dose, which minimizes side effects.

Trajectory 2025 to 2026? Revlimid has full generic entry in January 2026. We continue to invest in growth drivers, 2026 could be boosted by new approvals.

Camzyos has consistent growth with a strong subscriber base. The coming nHCM data readout may add a significant amount of potential patients.

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