Gilead Sciences 8-K

Summary

Q3 2026 results with FY2026 guidance raised. Product sales excluding Veklury grew 16%, led by HIV, while Gilead raised its FY2026 product sales outlook again, bringing the total increase to $1.6B since the start of 2026. The quarter also brought U.S. approval of Bixlenvo, Gilead’s single-tablet HIV regimen, and European approval of Trodelvy with Keytruda for certain first-line metastatic triple-negative breast cancer patients.

Key Figures

• Product sales excluding Veklury rose 16% to $8.2B. HIV growth reflected higher realized prices, increased HIV-prevention demand and favorable inventory dynamics; Biktarvy sales rose 10% to $4.1B and Descovy rose 49% to $1.0B. Trodelvy sales increased 42% to $506M, while Veklury fell 69% to $86M as COVID-19-related hospitalizations declined, and cell therapy sales fell 18% to $355M amid competitive pressure.
• Product gross margin gains were primarily driven by the expiration of a royalty-related obligation. Total revenue growth also reflected royalty, contract and other revenues falling to $11M from $424M, mainly because prior-year revenue from a previous intellectual-property sale did not recur.
• The 9M GAAP loss included $11.3B of acquired in-process research and development expense and $1.75B of in-process research and development impairments. Cash, cash equivalents and marketable debt securities were $6.4B at 9/30/2026, down from $10.6B at year-end 2025; YTD cash outflows included $11.3B for acquisitions, $2.8B for debt repayments, $3.1B in dividends and $1.1B in repurchases, partly offset by $11.2B of operating cash flow and $4.1B of net debt proceeds. Q3 dividends were $1.0B and repurchases were $370M. FY2026 loss-per-share guidance includes an ≈$9.88 impact from $12.4B of acquired in-process research and development charges, net of the Lakefront collaboration impact and related taxes.

Guidance

Guidance changes, derived from earlier filings

Metric	Period	Earlier guidance	Guidance now	Change
Product sales	FY2026	$30.1B-$30.4B	$31B-$31.3B	raised
Product sales excluding Veklury	FY2026	$29.8B-$30.1B	$30.7B-$31B	raised
Veklury sales	FY2026	≈$300M	≈$300M	reaffirmed
Diluted loss per share, GAAP	FY2026	$(3.75)-$(3.40)	$(4.40) to $(4.05)	lowered
Diluted loss per share, non-GAAP	FY2026	$(0.65)-$(0.30)	$(1.20) to $(0.85)	lowered
Operating income (loss), GAAP	FY2026	$(2.25)B-$(1.85)B	$(3.15)B to $(2.75)B	lowered
Operating income, non-GAAP	FY2026	$2.9B-$3.3B	$2.0B-$2.4B	lowered
Product gross margin, GAAP	FY2026	≈79.0%	≈79%	reaffirmed
Product gross margin, non-GAAP	FY2026	≈87.0%	≈87%	reaffirmed
Effective tax rate, GAAP	FY2026	≈(80%)-(90%)	≈(50%)-(55%)	narrowed (raised low end, lowered high end)
Effective tax rate, non-GAAP	FY2026	≈140%-115%	≈220%-165%	raised

Investor Takeaways

• Track HIV and HIV-prevention sales in coming quarters: sustaining the quarter’s 18% HIV sales growth and near-doubling of prevention sales would support the growth outlook.
• FY2026 product sales versus the raised outlook will test whether growth beyond Veklury continues to offset declines in Veklury and cell therapy.
• Biktarvy’s Medicare Maximum Fair Price takes effect 1/1/2028; watch for the resulting revenue impact. Gilead plans to start a Phase 3 study of emvistegrast, an investigational oral ulcerative colitis treatment, in 2027.