Weight-Loss Drugs 2.0: Can BioNxt and Merck Catch Up with Novo Nordisk and Eli Lilly? What About BioNTech?

BioNxt Solutions: Steady Progress

BioNxt’s approach starts with a practical problem: some patients have difficulty swallowing tablets. The Canadian company is therefore developing, among other things, thin films designed to dissolve under the tongue and release active ingredients through the oral mucosa. With its lead candidate, BNT23001, BioNxt is focusing on cladribine for relapsing-remitting multiple sclerosis. The active ingredient is already well-established through Merck’s Mavenclad. However, BioNxt must demonstrate that its own formulation works reliably and offers economically significant added value.

The business model generally focuses on commercializing its own formulations and intellectual property rights; the goal is not to invent new drugs, but to improve their dosage forms. Potential sources of revenue include licensing fees, development milestones, and royalties from future sales. In the spring, the Canadian company announced a Eurasian letter of intent, thereby establishing a framework for exclusive negotiations.

BioNxt reported its most significant operational progress in August, completing the Investigational Medicinal Product Dossier (IMPD) for BNT23001. The IMPD compiles, among other things, information on manufacturing, quality, and preclinical studies. Following a final review, the human trial is moving closer to reality. A comparison with Mavenclad is planned to examine drug absorption, blood concentrations, and tolerability.

The patent portfolio provides a safety net. As early as April, BioNxt reported on unified European patent protection for its cladribine film technology in 18 countries. This can facilitate negotiations and limit copycats. Progress is also being made in other areas. BioNxt recently finalized plans for a comparative large-animal study of an everolimus film to prevent organ rejection.

Merck: The Market Is There, but So Is Price Pressure

Merck is now far more than a traditional pharmaceutical company. Its business rests on three pillars: Healthcare, Life Science, and Electronics. In its Healthcare division, Merck develops and markets medications, including the MS drug Mavenclad, which contains the active ingredient cladribine. However, this segment faces fierce competition from generic drugs.

In addition, the company is collaborating with the Chinese pharmaceutical group Hansoh Pharma to develop a new orally administered GLP-1 agent to treat obesity. Unlike the well-known weight-loss injections from Novo Nordisk and Eli Lilly, Merck is focusing on a tablet solution. However, the drug is still in clinical development.

In its Life Science division, Merck supplies laboratory chemicals, research reagents, and technologies for biopharmaceutical manufacturing—in other words, products that pharmaceutical and biotech companies need to conduct research and produce medicines. Its Electronics division develops specialty materials and chemicals for the semiconductor and display industries.

In the second quarter, Merck generated EUR 5.43 billion in revenue and posted adjusted operating profit (EBITDA) of EUR 1.60 billion. Net income declined to EUR 494 million, while net debt stood at EUR 9.21 billion at the end of the first half of the year. Analysts estimate the stock’s upside potential over the next 12 months at an average of around 10%.

BioNTech: Positive Cancer Data, High Capital Expenditures

BioNTech is building out its future business in cancer drugs. While the COVID-19 vaccine business and partnerships are currently generating revenue, research and restructuring are extremely costly. Most recently, the company announced the closure of three sites in Germany. The founding couple will also soon leave the company to devote themselves to various research projects at another company.

BioNTech and OncoC4 recently reported concrete progress regarding Gotistobart. Among 87 previously treated patients with a specific form of lung cancer, the median overall survival was 18.5 months, compared to 10 months with the comparator chemotherapy. These are encouraging signs, but the data come from the first part of the Phase 3 PRESERVE-003 trial, which is not decisive for regulatory approval. The decisive second part is still ongoing.

Financially, the restructuring is costly. In the first six months of the current fiscal year, revenue of EUR 223.7 million was offset by a net loss of EUR 1.35 billion. In August, BioNTech lowered its 2026 revenue forecast to EUR 1.6 to 1.9 billion. Cash and cash equivalents and securities totaling approximately EUR 16.6 billion as of the reporting date nevertheless provide considerable financial flexibility. On average, analysts assign the share upside potential of around 20%.

BioNxt has several strings to its bow and could soon be making significant strides toward the first human trial of its cladribine film. Merck also wants to compete in this market but is feeling significant pressure from generic drug manufacturers. BioNTech can keep pursuing its cancer programs longer thanks to its financial reserves, but it must justify the high capital investment with strong clinical results.

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