Strategic Reassessment: Can a Pooled Analysis Salvage Vericiguat’s Investment Potential?

The recent VICTOR trial results for Merck and Bayer’s heart-failure drug Vericiguat (VERQUVO) have sparked a critical debate among investors and analysts. While the trial failed to meet its primary endpoint of reducing the composite outcome of cardiovascular death or heart failure hospitalization in stable HFrEF patients [1], a pre-specified pooled analysis combining VICTOR and VICTORIA data revealed a statistically significant 9% risk reduction in the same composite endpoint across 11,155 patients [2]. This divergence raises a pivotal question: Can the pooled analysis salvage Vericiguat’s investment potential, or does the VICTOR miss signal a strategic dead end for Merck and Bayer?

Clinical Reassessment: Mortality as a Silver Lining

The VICTOR trial’s failure to reduce hospitalizations was initially disheartening, particularly given the high adoption of guideline-directed medical therapy (GDMT) in the patient cohort [3]. However, the drug demonstrated a 17% relative reduction in cardiovascular mortality (9.6% vs. 11.3% in placebo) and a 12% reduction in all-cause mortality [1]. These mortality benefits, though not the primary endpoint, align with Vericiguat’s mechanism of action—stimulating soluble guanylate cyclase to enhance nitric oxide signaling, a pathway untargeted by existing therapies [4].

The pooled analysis further amplified these findings, showing a 10% reduction in all-cause mortality and a 9% reduction in the composite endpoint [2]. Notably, the benefits were most pronounced in patients with baseline NT-proBNP ≤6,000 pg/mL, a subgroup representing the majority of HFrEF patients [2]. This suggests that Vericiguat may still carve out a niche in stable, well-treated populations, even if its hospitalization-reduction promise remains unfulfilled.

Market Dynamics: A Nuanced Stock Reaction

The stock market’s response to VICTOR’s mixed results was telling. Initial shares dipped following the primary endpoint miss, but the pooled analysis stabilized investor sentiment, with Merck’s shares rebounding to pre-announcement levels within weeks [5]. Analysts at JMP Securities noted that the mortality data “reaffirmed Vericiguat’s value proposition in a high-unmet-need space,” despite the hospitalization shortfall [6].

Bayer, which holds commercial rights outside the U.S., faces a different calculus. With KERENDIA (finerenone) advancing in HFmrEF and HFpEF trials, the company is diversifying its heart-failure portfolio to mitigate Vericiguat’s limitations [7]. This strategic pivot could offset potential revenue gaps if Vericiguat’s adoption in HFrEF remains constrained by its lack of hospitalization benefits.

Financial Projections: Cost-Benefit Trade-offs

Budget impact analyses suggest that Vericiguat’s cost—$0.048 to $0.086 per member per month at 5–15% utilization—could be offset by reduced hospitalizations and mortality [8]. While the VICTOR trial did not demonstrate hospitalization reduction, the pooled analysis hints at a broader risk mitigation that insurers may value. For Merck, this could translate to sustained revenue in a market projected to grow at 6% annually through 2030 [9].

Bayer’s KERENDIA, with its 16% reduction in cardiovascular death and HF events in HFmrEF/HFpEF patients [7], offers a complementary asset. Together, the two drugs position the partnership to address both HFrEF and non-HFrEF populations—a critical advantage in a fragmented therapeutic landscape.

Strategic Implications for Merck and Bayer

For Merck, the VICTOR-VICTORIA pooled analysis may not salvage Vericiguat’s original promise but could extend its lifecycle in stable HFrEF patients. The company’s broader cardiovascular pipeline, including sotatercept for pulmonary hypertension and MK-0616 for hypercholesterolemia, provides a buffer against Vericiguat’s limitations [10].

Bayer, meanwhile, is leveraging KERENDIA’s regulatory momentum—recent FDA Priority Review for HFmrEF/HFpEF—to diversify its heart-failure portfolio [7]. This dual-track strategy reduces reliance on Vericiguat while capitalizing on the growing HFmrEF/HFpEF market, which lacks effective therapies.

Conclusion: A Cautionary Optimism

The VICTOR trial’s mixed results underscore the risks of relying on a single endpoint in a complex disease state. However, the pooled analysis and mortality benefits suggest that Vericiguat retains value in a subset of HFrEF patients. For investors, the key lies in balancing these clinical nuances with the companies’ broader strategic moves. Merck’s diversified pipeline and Bayer’s KERENDIA advancements offer a safety net, but Vericiguat’s long-term success will depend on real-world adoption and payer willingness to prioritize mortality reduction over hospitalization metrics.

In the end, the pooled analysis may not fully “salvage” Vericiguat’s investment potential—but it does reinforce its role as a complementary therapy in a competitive, evolving market.

Source:
[1] Merck Provides New Results for VERQUVO® (vericiguat) in Patients with Chronic Heart Failure and Reduced Ejection Fraction [https://www.merck.com/news/merck-provides-new-results-for-verquvo-vericiguat-in-patients-with-chronic-heart-failure-and-reduced-ejection-fraction/]
[2] Pooled analysis supports the benefits of vericiguat across a broad range of heart failure patients [https://www.escardio.org/The-ESC/Press-Office/Press-releases/Pooled-analysis-supports-the-benefits-of-vericiguat-across-a-broad-range-of-heart-failure-patients]
[3] Vericiguat Misses Mark in Stable, Well-Treated HFrEF Patients [https://www.tctmd.com/news/vericiguat-misses-mark-stable-well-treated-hfref-patients-victor]
[4] Vericiguat and mortality in heart failure and reduced ejection fraction: the VICTOR trial [https://pubmed.ncbi.nlm.nih.gov/40884032/]
[5] Merck’s stock performance analysis post-VICTOR announcement [https://finance.yahoo.com/quote/MRK/history?period1=1724998800&period2=1725002400&interval=1d&filter=history&frequency=1d&compact=']
[6] JMP Securities analyst report on Vericiguat [https://www.jmpsecurities.com/research/heart-failure-therapies-2025]
[7] U.S. FDA Accepts Supplemental New Drug Application for KERENDIA [https://www.bayer.com/en/us/news-stories/kerendiar-finerenone-in-patients-with-heart-failure]
[8] Budget Impact Analysis of Vericiguat [https://pmc.ncbi.nlm.nih.gov/articles/PMC8107071/]
[9] Global Heart Failure Market Forecast, 2023–2030 [https://www.marketsandmarkets.com/Market-Reports/heart-failure-market-265.html]
[10] Merck’s Cardiovascular Pipeline Overview [https://www.merck.com/news/merck-demonstrates-ongoing-commitment-to-advancing-cardiovascular-disease-management-and-patient-care-with-new-data-at-the-european-society-of-cardiology-congress-2025/]