Progress Like Clockwork

Back in 2016, I told a hedge fund crowd in Tokyo that Gilead (GILD) was the biotech equivalent of a Seiko Spring Drive. Quietly brilliant, ruthlessly precise, engineered to perform for decades without needing applause. A few chuckled. Then Biktarvy happened. Now Yeztugo is here, and those same folks are calling me for dinner reservations in San Francisco.

Funny how the tape catches up with reality eventually.

If you want to understand Gilead today, follow the currents in HIV prevention and treatment where the company reigns like a veteran marathoner who hits stride while others are still stretching.

Biktarvy generated $3.69 billion in Q3 2025, up 6.2% year over year. It remains the most prescribed HIV regimen globally and sits at the center of care in more than 100 countries.

That is what a franchise drug looks like when it matures. You don’t notice the growth until one day you wake up and realize it has built a revenue wall no competitor seems able to breach.

Then came lenacapavir. Yeztugo, the twice-yearly injectable pre-exposure prophylaxis, received FDA approval on June 18 and European approval on August 26.

It posted $39 million in Q3 2025 sales, more than doubling quarter over quarter, and management has signaled close to $100 million for Q4. Those numbers are backed by infrastructure, not hype.

Gilead secured a permanent Medicare and commercial reimbursement J code effective October 1, nearly two months ahead of expectations, and achieved 75% payer coverage within the United States during its very first quarter on the market.

The biology is just as compelling. Lenacapavir is the first capsid inhibitor with a half-life long enough to sustain effective prophylaxis with two injections per year.

In the pivotal PURPOSE trials, lenacapavir demonstrated greater than 85% risk reduction compared with placebo, reshaping the long-acting prevention landscape.

Gilead has not stopped with standalone prevention.

In December, the ARTISTRY 2 Phase 3 readout confirmed that bictegravir paired with lenacapavir was statistically non-inferior to Biktarvy in treatment-naive patients. ARTISTRY 1 showed similar results in multi-tablet comparisons.

Regulatory submissions are likely to begin in 2026, positioning Gilead to replace its own best seller with a successor that stretches dosing intervals and strengthens patent life well into the next decade.

Outside its HIV fortress, the company continues to build an increasingly muscular liver portfolio.

Livdelzi, acquired with CymaBay Therapeutics, is rapidly becoming the first-line next-generation treatment for primary biliary cholangitis.

Q3 sales hit $100 million, up nearly 30% from Q2. Ipsen’s rival therapy Iqirvo logged roughly $56.6 million over the same period, despite having launched roughly three months earlier.

Physicians are not choosing Livdelzi because of the marketing splash. They are choosing it because it delivers greater reductions in alkaline phosphatase and ALT while relieving pruritus, a symptom that pushes patients to seek new therapies faster than abstract lab values ever could.

Meanwhile, the withdrawal of Intercept’s Ocaliva from the United States and Europe removes the incumbent that many assumed would remain the standard. The lane is open, and Gilead is accelerating.

If the company has one bruise, it sits in oncology.

Kite Pharma was meant to give Gilead teeth in cancer. Nine years and $11.9 billion later, that promise remains only partially fulfilled.

Combined revenue from Yescarta and Tecartus fell to $432 million in Q3, down nearly 11% year over year.

The competitive environment is merciless. Roche (RHHBY) and Johnson and Johnson (JNJ) have begun to dominate relapsed and refractory lymphoma with Columvi and Breyanzi, therapies boasting either better safety, a simpler treatment pathway, or both.

However, anito cel, developed with Arcellx (ACLX), reported Phase 2 response data broadly comparable to Carvykti in multiple myeloma last December. If that efficacy translates into later-stage trials, Gilead may yet gain a meaningful foothold in the most lucrative cell therapy market.

Through all of this, the business behind the science keeps humming.

Q3 non-GAAP earnings reached $2.47 per share, up more than 22% from a year ago, and operating margins touched 45.2%, their highest level in over 3 years.

Revenue and earnings estimates for the upcoming quarter appear conservative at $7.68 billion and $1.89 per share, respectively. Analysts have underestimated Gilead in 8 of the last 11 reporting cycles, and the conditions that fueled those beats remain intact.

Investing demands a different temperament when studying a company like Gilead.

It’s not the flashy innovator chasing headlines or promising to cure everything with CRISPR. It quietly dominates entrenched markets, extends its lead with science that is validated, advances multiple shots on goal, and returns the favor in growing cash flow. It’s the kind of firm that rewards those willing to wait while the rest of the street scrolls the hype feeds.

And for my friends from that Tokyo meeting, consider this fair warning. Seiko keeps perfect time. And this one still has a lot of hours left to run.

I suggest you buy the dip.