Analyst Initiates Coverage of Co. With 'Once-in-a-Generation' Drug
Research Report

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Disclaimers H.C. Wainwright & Co., NewAmsterdam Pharma Co. N.V., December 30

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NewAmsterdam Pharma Company N.V.'s (NAMS:NASDAQ) drug obicetrapib is "once-in-a-generation" drug for cardiovascular disease, H.C. Wainwright & Co. Analyst Ed Arce said in a research note initiating coverage of the company on December 30.

The drug "has the clinical profile to be transformational for millions of patients not at goal on statins," the analyst wrote, giving the stock a Buy rating with a US$48 per share price target, an 86% premium over its price when the note was issued.

Based in the Netherlands,NewAmsterdam is a late-stage biopharma company developing obicetrapib, a next-generation cholesterol ester transfer protein (CETP) inhibitor to lower LDL-C, as an adjunct to statin therapy for patients at risk of cardiovascular disease (CVD) for whom existing therapies are insufficient or not tolerated, the analyst wrote.

"We believe that obicetrapib, as a low-dose, oral, once-daily treatment, may emerge as the preferred lipid-lowering therapy (LLT) for patients with hypercholesterolemia — due to either to atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH) — as monotherapy or as a fixed-dose combination (FDC) with ezetimibe," he noted.

Positive Topline Results

The company reported positive topline results from its Phase 3 study on the drug, the last of three pivotal LDL-C lowering studies.

"Obicetrapib 10 mg successfully achieved (p<0.0001) the primary endpoint of the LS mean (with imputation) of 12-week LDL-C % reduction vs. placebo (max tolerated LLTs) in all three studies," Arce wrote.

However, the big positive surprise from Phase 3 was a 21% reduction (HR=0.79) in the first 4-point MACE at just one year, versus the expected 9% relative MACE risk reduction, suggesting significant positive benefit from multiple factors beyond LDL-C lowering, according to the analyst.

"Importantly, obicetrapib is generally well-tolerated with no increase in blood pressure and safety comparable to placebo, including liver enzymes, hs-CRP, and renal function," Arce wrote. "We now expect the ongoing Phase 3 CVOT PREVAIL study (NCT05202509; n=9,541)

to demonstrate a 25%+ MACE benefit, significantly higher than other agents on market or in development, including the 15% benefit on injectable PCSK9 inhibitors," he said.

"As such, we believe obicetrapib is poised to become the standard-of-care (SoC) second-line therapy (on top of statins) to further reduce residual CV risk," Arce continued.

Benefits Could Extend Past LDL-C Lowering

According to the research report, "NewAmsterdam's hypothesis is that obicetrapib, the most potent CETP inhibitor (97%), has differentiated features that enable it to provide MACE benefits beyond what is expected solely on the impact of LDL-C lowering alone, as described by CTTC (Lancet. 2010 376:1670-81)."

Arce wrote, "We employ a risk-adjusted NPV (rNPV) valuation model to estimate the value of NAMS shares, and arrive at our US$48 PT based on: (1) about US$29 per share for U.S. net sales and EU royalties on obicetrapib in secondary ASCVD prevention (assume commercial launch in 1H27; 85% PoS; US$4.7B global peak revenues in 2042); and (2) about US$19 per share as a placeholder value for obicetrapib in primary ASCVD prevention (about 40% larger opportunity than secondary prevention; 40% PoS)."

The analyst said in the firm's valuation model, analysts are employing a 12% discount rate, which they believe adequately reflects the overall risks facing NewAmsterdam.

Risks include disappointing data from further studies, failure to secure regulatory approval of the drug, a smaller than anticipated market size, and significant delays to development timelines.