NewAmsterdam Pharma (NAMS) Q3 2026 earnings review
NewAmsterdam wins European drug approval, while trial costs climb
NewAmsterdam Pharma won its first regulatory approval worldwide as its cholesterol pill cleared the European Commission, while clinical trial spending climbed. Milestone payments from European partner Menarini lifted revenue to $19 million, and chief executive Michael Davidson started a 400-patient Phase 2b trial in early Alzheimer's disease. By our math, operating cash burn rose 21% from a year ago to $40 million as research costs expanded.
| Revenue | $19.2M $0.3M a year ago on European approval milestones |
|---|---|
| R&D expenses | $39.4M +27% from a year ago |
| Cash and marketable securities | $643.1M down $35M from last quarter |
| PREVAIL heart-outcomes interim plan | Unchanged events in Q4 2026, result in Q1 2027 |
⚖️ Verdict: 🟢 Bullish
The story got better because European approval for Ubeslo and Evlarco turns the biotech into a commercial royalty earner and validates its clinical data before US filing. Enrolling 347 patients in the RUBENS diabetes trial—above the 300-patient target—also removes execution risk ahead of year-end data. One caution: the drop in reported net loss to $17 million relied on a non-cash warrant accounting gain, while underlying trial spending accelerated.
The question now is whether the 9,500-patient PREVAIL heart-outcomes trial will show a large enough cut in heart attacks and strokes to stop early at its interim check. If the pill clears the high statistical bar at the interim look, NewAmsterdam can file for US approval a year early; if not, the trial runs to the end of 2027. The interim readout in the first quarter of 2027 will settle it.
🐂 Bull Case
European Approval Triggers Milestone Revenue and Launch
NewAmsterdam Pharma develops obicetrapib, a daily pill that lowers bad cholesterol by blocking cholesteryl ester transfer protein (CETP), a protein that moves cholesterol between blood particles. In September, the European Commission approved the drug alone as Ubeslo and combined with ezetimibe, an older cholesterol medicine, as Evlarco.
This marks the first regulatory approval worldwide for the therapy after Phase 3 trials cut bad cholesterol by up to 40% alone and about 50% in combination, with side effects "comparable to placebo". Italian partner Menarini Group holds exclusive European sales rights and triggered $19.2 million in third-quarter revenue from "certain regulatory milestones under the license agreement with Menarini".
- Third-quarter revenue: $19.2 million, up from $0.3 million a year ago
- Remaining milestone pool from Menarini: up to 817 million euros, down from 833 million euros at year-end
- European royalties: tiered from low double-digits to the mid-twenties on net sales
The approval matters because it shifts the biotech from pure research into commercial royalties without paying for a European sales force. What to watch: Menarini's initial commercial launch in Germany by year-end 2026, followed by the United Kingdom in 2027. Early prescription uptake in Germany will show whether European doctors adopt the pill before heart-attack outcomes data arrive.
Alzheimer's Trial Starts as Larger Phase 2b
Chief executive Michael Davidson highlighted "the initiation of the SPINOZA Phase 2b trial in preclinical Alzheimer’s disease" after dosing the first patient in September. Previous company updates described this planned study as a smaller Phase 2a trial, so management expanded the scope as it moved into the clinic.
SPINOZA will test obicetrapib in about 400 people who have blood markers of early Alzheimer's pathology and carry specific risk genes called ApoE3 or ApoE4. The design builds on a 1,535-patient analysis from the BROADWAY cholesterol trial, which showed the "strongest observed biomarker response in ApoE4/E4 participants" by lowering p-tau217, a blood protein linked to brain plaques, over 12 months. What to watch: enrollment updates for the 400 participants over the coming quarters, because rapid recruitment would show strong patient interest in a preventative daily pill.
Diabetes Trial Over-Enrolls Ahead of Year-End Readout
NewAmsterdam is running RUBENS, a Phase 3 study testing obicetrapib alone and with ezetimibe in patients who have type 2 diabetes or metabolic syndrome alongside high cholesterol. The company started the trial in December 2025 with a target of roughly 300 patients.
In August, the biotech finished enrolling 347 patients, beating its target by 15.7% by our math, and kept its timeline for top-line results around the end of 2026. Over-enrolling in eight months shows strong clinical demand among patients with metabolic syndrome. What to watch: the RUBENS top-line data readout around year-end 2026, where cholesterol reductions matching the 40% to 50% seen in prior trials would strengthen the drug's profile in diabetic patients.
🐻 Bear Case
Expanding Clinical Trials Drive Up Cash Burn
Running three ongoing Phase 3 heart studies while starting a 400-patient Alzheimer's trial is lifting NewAmsterdam's cost base. Research and development spending rose 27.1% from a year ago to $39.4 million in the third quarter, driven by an "increase in clinical and personnel expenses".
Selling, general and administrative costs dipped 2.1% to $24.0 million as lower staff pay offset spending on "organizational commercial readiness activities". Even with the European milestone payment, operating cash outflow reached $39.8 million in the third quarter by our math, up 21.4% from $32.8 million a year earlier. Liquid assets—cash, cash equivalents and marketable securities—fell by $35.1 million during the quarter to $643.1 million.
The company still holds plenty of cash, but the quarterly burn rate is rising just as it prepares for a potential US commercial launch. What to watch: fourth-quarter operating cash outflow and R&D expenses when full-year results arrive in February. A further jump in clinical spending would shorten the cash buffer needed to build a US sales team.
Smaller Loss Rests on Warrant Accounting and Milestones
On the surface, NewAmsterdam's third-quarter net loss shrank by 75.9% from a year ago, dropping from $72.0 million to $17.4 million, or $0.14 per share. However, the improvement did not come from lower operating costs.
More than half of the year-over-year improvement came from "changes in the fair value of the Company’s derivative warrant liabilities", which produced a non-cash accounting gain of $23.1 million this quarter against a $23.8 million loss a year ago. Excluding warrant swings, the net loss was $40.5 million by our math, and even that figure benefited from $19.2 million in irregular milestone revenue while operating expenses rose 14.2%. What to watch: operating loss excluding milestone payments in the fourth quarter, which will show the true underlying cost of running the business.
👓 Other Themes
European Cardiology Presentations Back Safety and Efficacy
At the European Society of Cardiology Congress in August, NewAmsterdam presented three studies addressing historical questions around cholesterol drugs that raise good cholesterol (HDL-C). Using genetic and observational data, the company showed that high HDL-C does not raise death risk once researchers control for alcohol consumption, while pooled Phase 3 data confirmed consistent bad-cholesterol reductions.
Cardiovascular Disease Mortality and Undertreatment
NewAmsterdam highlighted that US age-adjusted death rates from heart disease rose 9% between 2019 and 2022, undoing a decade of medical progress. Although doctors wrote 269 million cholesterol prescriptions over the past year, about 40 million treated US adults still fail to reach their target cholesterol levels, and another 20 million diagnosed patients take no treatment at all.
💲 Other KPIs
Prepayments and other receivables—cash paid in advance for clinical trials or owed by partners—jumped 76.8% from last quarter's $24.0 million and rose 11.2% from $38.1 million at year-end. The third-quarter increase tied up $4.1 million of operating cash over the first nine months, reflecting the recognition of Menarini regulatory milestones and new trial startups.
Current deferred revenue—upfront or milestone cash received from partner Menarini that the biotech has not yet earned on its income statement—more than doubled from $2.8 million in the second quarter. After holding flat in the first quarter and falling 29.8% in the second, the $2.9 million quarterly rebound added to operating cash flow.
The company's average share count rose 4.3% from 119.0 million a year ago. Employees and investors exercised 3.5 million stock options and 1.6 million pre-funded warrants during the first nine months of 2026, bringing in $27.6 million of financing cash while gradually diluting existing shareholders.
🔮 Guidance
Unchanged. Management still anticipates "reaching the predefined event number for the planned PREVAIL interim analysis in the fourth quarter, with the outcome expected in the first quarter of 2027". PREVAIL is a 9,500-patient trial testing whether obicetrapib prevents major heart attacks and strokes; if it does not stop early for overwhelming success, full completion is due by year-end 2027.
Unchanged. The company continues to expect top-line cholesterol results from the 347-patient RUBENS diabetes and metabolic syndrome trial around the end of 2026. Completing enrollment in August—four months ahead of the year-end readout window—keeps this schedule on track.
Unchanged for Germany, slightly later for the United Kingdom. Partner Menarini plans to launch Ubeslo and Evlarco in Germany by the end of 2026 and in the United Kingdom during 2027, whereas first-quarter notes mentioned potential fourth-quarter 2026 launches for both countries.
❓ Key Questions
How much milestone cash arrived vs receivables?
NewAmsterdam booked $19.2 million in third-quarter revenue from Menarini regulatory milestones, but prepayments and other receivables jumped by $18.4 million over the same three months. Did Menarini pay the milestone in cash during the third quarter, or will that cash arrive in the fourth quarter?
What is the statistical bar to stop PREVAIL early?
The company expects to hit the target number of heart events for the PREVAIL interim check in the fourth quarter and read out the result in the first quarter of 2027. What exact statistical threshold must obicetrapib clear at this interim look to stop the trial early?
When will the 400-patient SPINOZA trial finish enrolling?
Management upgraded the SPINOZA Alzheimer's study from a Phase 2a to a 400-patient Phase 2b trial and dosed the first participant in September. How long will it take to screen and enroll 400 people with specific ApoE genotypes and early Alzheimer's blood markers?
When are UK and Swiss regulatory decisions due?
Earlier filings pointed to regulatory approval decisions in the United Kingdom and Switzerland during the second half of 2026 alongside the European Union. With European Commission approval now in hand and a UK launch set for 2027, when does Menarini expect formal UK and Swiss approvals?