Analyst Conference Summary

biotechnology

conference date: April 24, 2025 @ 1:30 PM Pacific Time
for quarter ending: March 31, 2025 (first quarter, Q1 2025)

Forward-looking statements

Overview: Flat y/y revenue on Veklury revenue drop.

Basic data (GAAP):

Revenue was $6.67 billion, down 12% sequentially from $7.57 billion and nearly flat from $6.69 billion in the year-earlier quarter.

Net income was $1.32 billion, down 26% sequentially from $1.78 billion and well up from negative $4.17 billion year-earlier.

Earnings per share (EPS, diluted) were $1.06, down 25% sequentially from $1.42, and up from negative $3.34 in the year-earlier quarter.

Guidance:

2025 guidance was unchanged except lowered diluted EPS estimate to $5.65 to $6.05. Non-GAAP EPS estimate unchanged at $7.70 to $8.10.

Conference Highlights:

Daniel O'Day, CEO, said "Gilead had a strong start to the year driven by excellent commercial and clinical execution along with disciplined expense management. Our base business grew 4% year-over-year, primarily led by Biktarvy’s continued strength, and we announced positive topline Phase 3 results for Trodelvy plus pembrolizumab in first line PD-L1+ metastatic triple negative breast cancer. With the upcoming June PDUFA date for lenacapavir for HIV prevention, and continued progress across our diverse pipeline, we look forward to building on our positive momentum throughout the year." Sales increase 4% y/y excluding Veklury for Covid. Gilead has no major loss of drug exclusivity until late 2033. Most of Gilead manufacturing is located in the U.S.

The dividend of $0.79 per share, is to be paid on June 27, 2025 to shareholders of record as of June 13, 2025.

In Q1 2025 Trodelvy plus Keytruda demonstrated a statistically significant and clinically meaningful improvement in PFS in patients with previously untreated PD-L1+ unresectable locally advanced or metastatic triple-negative breast cancer in a Phase 3 trial.

In Q1 the EU granted conditional marketing authorization for seladelpar for PBC in combination with UDCA, or as monotherapy for those intolerant of UDCA.

Launch of Livdelzi (seladelpar) is going well after Q3 U.S. approval for PBC and related pruritis. In Q4 2024 seladelpar received a positive opinion in the EU for PBC (primary biliary cholangitis).

In Q4 2024 filed the NDA for twice-yearly lenacapavir for PrEP. The PDUFA date is June 19, 2025. In Q3 2024 Lenacapavir for HIV reported positive Phase 3 results for twice-yearly HIV prevention. For oral once-weekly dose combined with Merck's islatravir Phase 2 data also reported. Six royalty-free licensing agreements were signed with manufacturers for sale in resource-limited nations.

Trodelvy sales in Q1 2025 were down due to inventory issues, but demand continued to ramp.

Despite decline in sales, Veklury remains a standard of care for hospitalized Covid patients.

Gilead now has 61 clinical stage programs. Expects cancer program to generate one-third of revenue by 2030.

Non-GAAP numbers: Net income was $2.29 billion, down 4% sequentially from $2.39 billion and up from negative $1.64 billion year-earlier. Non-GAAP EPS was $1.81, down 5% sequentially from $1.90 and up from negative $1.32 year-earlier.

Product sales were $6.61 billion, down sequentially from $7.54 billion and down 1% from $6.65 billion in the year-earlier quarter.

Royalty, contract and other revenue was $54 million, up sequentially from $33 million, and up from $39 million year-earlier.

Cash and equivalents ended at $7.93 billion, down sequentially from $10.0 billion. $1.76 billion cash flow from operations. Capital expense $104 million. $1.65 billion free cash flow. $ million was used to repurchase shares. $ million paid in dividends. Long term liabilities were $25.0 billion.

Numerous other studies are underway or planned; see Gilead pipeline.

Expenses were $4.43 billion, consisting of $1.54 billion for cost of goods sold; $1.38 billion for R&D; $253 million acquired in-process R&D; $1.26 billion SG&A. Leaving income from operations of $2.24 billion. Interest expense $260 million. Other expense $328 million. Income tax expense $334 million.

Capital allocation priorities are to grow the dividend and pay down debt. No near term plans for a major acquisition.

Q&A selective summary:

PrEP launch expectations, reimbursements? Getting ready for the launch. We believe we will have about 75% access after 6 months. In 2026 there should be much stronger access.

Changes at regulators, etc.? To date nothing to alter our plans, nothing adverse to our business. Discussing Len with policy makers. We can help grow the PrEP market by increasing awareness and screening. So far all FDA interactions have been on track, not just for Len but for all our clinical trials.

Descovy revenue bump in Q1? Driven by both higher demand and higher price. PrEP market is growing. We also gained share of market, due to our marketing team activities. This should also support the Len launch.

What tariffs affect our supplies have been figured into guidance. Vast majority of our IP is in the U.S. 80% of our profits are recognized in the U.S. We do have manufacturing outside the U.S. and can flex that according to demand ourside the U.S. Weak U.S. dollar also helps us.

Part D redesign? Medicare claims will lag by a quarter. We expect a $1.1 billion annual impact.

Trodelvy? Q/Q was due to inventory and a strong Q4. We have not seen impact, so far, from new entrants in the market.

Livdelzi launch? Going well, expect to continue to build.

Once yearly Len for PrEP? Looking to study design options, including a PK based approach.

Awareness of providers and community for Len for PrEP? Awareness is high in both. We want to create a smooth customer experience. We are pre-training for all aspects from injections to tracking reimbursement.

OpenIcon Analyst Conference Summaries Main Page

Gilead Investor Relations page

More Gilead analyst conference summaries

Search

More Analyst Conference Pages: