Issue 171  /  September 25, 2026  /  Feature

The $900 IVF Drug Now Sells For $168

Filings from Merck KGaA and Organon show US revenue from injectable FSH resetting on price. That changes the math behind EMD Serono's bet on an all-oral IVF regimen.

The $900 IVF Drug Now Sells For $168

If you read Merck KGaA's fertility disclosures since early 2025 alongside Organon's two most recent 10-Q filings, one pattern holds across both.

The recombinant FSH injections at the center of US ovarian stimulation are earning less in the United States than they did a year ago, and both companies attribute the change to US pricing.

On September 9, EMD Serono, the US and Canadian healthcare business of Merck KGaA, acquired two small-molecule programs from PostEra, an AI drug discovery company. One targets the FSH receptor for ovarian stimulation.

The other targets the LH/hCG receptor, for ovulation trigger in IVF and for some male infertility patients. PostEra says the pair could eventually move IVF from injections to an all-oral regimen. Both programs are preclinical, their safety and efficacy in humans have not been established, and the terms were not disclosed.

In October 2025, EMD Serono agreed with the administration to sell Gonal-f, Ovidrel and Cetrotide directly to eligible self-pay patients at an 84% discount off list price when all three are used in a typical protocol. TrumpRx went live in February 2026.

CNN reported in May that Gonal-f, with a list price above $900, was listed on the site at $168, and that EMD Serono said more than 19,000 patients had accessed its fertility therapies through the program. The patient figure is company-stated and has not been independently audited. The discount applies to self-pay patients, and what insured patients pay depends on their plan.

Organon told analysts in February that it expected an increasingly competitive US fertility market in 2026, brought on by a competitor's agreement with the administration's direct access program.

Its Q2 10-Q reports US revenue for Follistim AQ of $17 million in the quarter, down from $30 million a year earlier, a 43% decline. For the first half, US Follistim revenue was $38 million against $65 million in 2025, down 42%. Worldwide first-half Follistim revenue fell 16%, from $142 million to $120 million, which Organon attributes to a competitive-driven price reduction in the United States. The company expects year-over-year declines to continue through 2026 and to stabilize once a full year has passed since the reduction. The filing does not separate price from volume, so how much of the decline reflects lower net prices rather than fewer patients cannot be read from it.

Merck KGaA reports organic growth rates rather than US product revenue, so the size of the US effect on Gonal-f cannot be calculated from its releases. Gonal-f declined 6.7% organically in 2025 against 2024, and 2.7% in Q2 2026 against Q2 2025.

On the August 6 earnings call, Danny Bar-Zohar, CEO of Merck KGaA's healthcare business, told analysts that its Fertility and Endocrinology unit improved from a 5% decline in Q1 to a 1% decline in Q2 as the effect of a US Gonal-f price reduction taken in Q2 2025 began to annualize.

A company selling an established injectable carries a cost when it develops that product's replacement, because every patient who moves to the new drug is revenue drawn from the old one. EMD Serono describes Gonal-f as the most prescribed FSH in the United States.

When US net prices on the injectable fall, the US revenue at stake in any future switch falls with them. EMD Serono has not said pricing shaped the PostEra acquisition. The filings show the conditions under which the deal was made.

The oral programs sit alongside a growing injectable franchise.

Pergoveris, EMD Serono's combined FSH and LH injection, grew 22.6% organically in 2025 against 2024 and 14.1% in Q2 2026 against Q2 2025. On the same August call, Bar-Zohar said the FDA had accepted its US submission, filed under the Commissioner's National Priority Voucher program, though approval remains uncertain because the data were largely generated outside the United States.

The first oral FSH receptor agonist tested in humans was MK-8389. In a 14-day, placebo-controlled study in healthy young women, Mireille Gerrits and colleagues reported in Fertility and Sterility in 2016 that it showed no clinically meaningful effect on follicle size or number, and produced a transient effect on thyroid function tests that caused no symptoms but prevented dosing above 40 mg. The authors were current or former employees of MSD, the drug's developer, and the study enrolled healthy volunteers rather than IVF patients.

A 2023 review in Frontiers in Endocrinology by Clara Lazzaretti and colleagues at the University of Modena and Reggio Emilia, who declared no conflicts, traces that thyroid signal to binding pockets the FSH receptor shares with the thyroid-stimulating hormone receptor, and names low specificity as the reason no gonadotropin receptor modulator of this kind is on the market.

This is not EMD Serono's first move toward oral IVF. In 2016 TocopheRx, an EMD Serono spinout seeded with $4.3 million from its venture arm, told MedCity News its business plan was to make IVF completely oral. Its founder, Stephen Palmer, previously led reproductive health research at Merck KGaA.

Palmer and TocopheRx colleagues reported in Frontiers in Pharmacology in 2020 that their lead compound, TOP5300, showed no appreciable thyroid activity in 14-day studies in rats and dogs. A 2023 study in Fertility and Sterility led by Joie Guner at Baylor College of Medicine, with Palmer as senior author, still described it as preclinical. In the PostEra announcement, co-founder and chief scientific officer Alpha Lee said there has been little progress in drugging these receptors with oral small molecules over the past few decades.

ASRM's Scientific Congress runs October 24 to 28 in Baltimore, followed by ASRM INNOVATE for clinicians, founders and investors on October 28 and 29. Merck KGaA reports third-quarter results on November 12, which will show whether Gonal-f's US pricing effect has fully annualized.

The oral regimen is still preclinical. The economics that make it worth owning are already in the filings.

This article is for informational purposes only and is not medical advice.

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— Keisha, Editor of The Luteal