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Merck Completes Acquisition of EyeBio

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Merck (NYSE: MRK) has completed the acquisition of Eyebiotech (EyeBio), now a wholly-owned subsidiary. This acquisition strengthens Merck's late-stage pipeline by adding Restoret™, a novel candidate for diabetic macular edema (DME) and neovascular age-related macular degeneration (NVAMD). Restoret™, a tetravalent, tri-specific antibody, showed positive results in a Phase 1b/2a study and will advance to a pivotal Phase 2b/3 trial in 2024. The transaction, treated as an asset acquisition, will result in Merck recording a $1.3 billion charge ($0.50 per share) in Q3 2024. Merck will update its financial outlook during its Q2 2024 earnings report on July 30.

Positive
  • Strengthens Merck's late-stage pipeline with the addition of Restoret™.
  • Restoret™ has shown positive results in Phase 1b/2a study for DME and NVAMD.
  • Scheduled advancement of Restoret™ to Phase 2b/3 trial in 2024.
Negative
  • Merck will record a $1.3 billion charge ($0.50 per share) in Q3 2024.

Insights

Merck's acquisition of EyeBio significantly strengthens its pipeline, particularly with the promising late-phase candidate, Restoret™, which targets diabetic macular edema (DME) and neovascular age-related macular degeneration (NVAMD). The transaction, however, comes with a notable financial implication—a charge of $1.3 billion, or approximately $0.50 per share in Q3 2024.

From a financial perspective, this acquisition can be seen as a strategic move aimed at future revenue growth. The pipeline diversification into the ocular disease space aligns with Merck's long-term strategy of expanding its therapeutics portfolio. The expense will be felt in the short term, reducing the EPS for the upcoming quarter, but it reflects a typical strategy in the pharmaceutical industry: sacrificing short-term profitability for long-term gains.

Investors should be cautiously optimistic. While the initial hit to financials could be seen as a drawback, the potential market for DME and NVAMD treatments is substantial. If Restoret™ successfully navigates late-stage trials and secures FDA approval, revenue could significantly offset the initial costs.

The acquisition of EyeBio brings forward Restoret™, an investigational tetravalent, tri-specific antibody targeting the Wnt signaling pathway. This is a promising development in treating retinal diseases like DME and NVAMD. The positive results from early-phase trials are encouraging, particularly in a field with limited effective treatments.

The Wnt pathway is important for retinal health and a drug that can modulate this pathway could offer a novel, first-in-class treatment option. The advance to a pivotal Phase 2b/3 trial scheduled for the latter half of 2024 will be a critical milestone. If the results continue to be positive, this could revolutionize the standard of care for patients suffering from these debilitating conditions.

For patients and physicians, the potential for improved treatment options is exciting. However, it is essential to remain cautious until more robust data from larger trials are available.

From a market perspective, the acquisition of EyeBio by Merck is a calculated move to enter the lucrative retinal disease market. Diabetic macular edema and neovascular age-related macular degeneration affect millions globally, with significant unmet need driving demand for innovative treatments.

The timing of this acquisition is noteworthy, as the market for ophthalmic drugs is expected to grow substantially, driven by aging populations and increasing prevalence of diabetes. By securing a late-phase candidate with Restoret™, Merck positions itself to capitalize on this growing market.

However, it's important to note the competitive landscape. Major players like Regeneron and Novartis already have established treatments, so Restoret™ will need to demonstrate superior efficacy or a differentiated safety profile to capture significant market share.

Overall, this acquisition is a strategic bet that, if successful, could lead to substantial market penetration and revenue growth for Merck.

Acquisition strengthens and diversifies Merck’s pipeline with the addition of Restoret™, a novel late-phase candidate for diabetic macular edema and neovascular age-related macular degeneration, as well as preclinical candidates

RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the completion of the acquisition of Eyebiotech Limited (EyeBio). EyeBio is now a wholly-owned subsidiary of Merck.

“The EyeBio acquisition further diversifies our late-stage pipeline with the addition of a promising candidate based on novel biology and genetics for the treatment of certain retinal diseases,” said Dr. Dean Y. Li, president, Merck Research Laboratories. “We are excited to welcome the EyeBio team and look forward to working together to advance Restoret for the patients that need it.”

EyeBio’s lead candidate, Restoret™ (EYE103), is an investigational, potentially first-in-class tetravalent, tri-specific antibody that acts as an agonist of the Wingless-related integration site (Wnt) signaling pathway. Based on positive results from the open-label Phase 1b/2a AMARONE study in patients with diabetic macular edema (DME) and neovascular age-related macular degeneration (NVAMD), Restoret is scheduled to advance into a pivotal Phase 2b/3 trial to evaluate its potential for the treatment of patients with DME in the second half of 2024.

Additional pipeline candidates include clinical and preclinical assets being developed for the prevention and treatment of vision loss associated with retinal vascular leakage, a known risk factor for retinal diseases.

Transaction details

Under the terms of the agreement, Merck, through a subsidiary, has acquired all outstanding shares of EyeBio. As previously disclosed, this transaction is being accounted for as an asset acquisition. Merck will record a charge of approximately $1.3 billion, or approximately $0.50 per share in the third quarter of 2024, which will be included in non-GAAP results. As a matter of policy, Merck provides updates to its financial outlook once each quarter and will provide an update to its full-year financial outlook when it reports second-quarter 2024 results on July 30.

About Restoret

Restoret is an investigational, potentially first-in-class tetravalent, tri-specific Wnt antibody designed to address unmet medical need in patients with retinal diseases, including diabetic macular edema (DME) and neovascular age-related macular degeneration (NVAMD). Restoret is administered as an intravitreal injection seeking to eliminate vascular leakage in retinal diseases by agonizing the Wnt pathway with the goal of restoring and maintaining the blood-retinal barrier. Preclinical evidence indicates that agonizing the Wnt pathway in the retina may reduce vascular leakage.

About Merck

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world - and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2023 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Media Contacts:

Robert Josephson

(203) 914-2372



Justine Moore

(347) 281-3754



Investor Contacts:

Peter Dannenbaum

(732) 594-1579



Damini Chokshi

(732) 594-1577

Source: Merck & Co., Inc.

FAQ

What is the significance of Merck's acquisition of EyeBio?

The acquisition strengthens Merck's late-stage pipeline with the addition of Restoret™, a novel candidate for DME and NVAMD.

What are the financial implications of Merck's acquisition of EyeBio?

Merck will record a $1.3 billion charge ($0.50 per share) in Q3 2024 due to the acquisition.

When will Restoret™ advance to the next phase of clinical trials?

Restoret™ is scheduled to advance to a pivotal Phase 2b/3 trial in the second half of 2024.

How did Restoret™ perform in initial studies?

Restoret™ showed positive results in the open-label Phase 1b/2a AMARONE study for DME and NVAMD.

How will the acquisition of EyeBio impact Merck’s financial outlook?

Merck will provide an updated financial outlook for the full year during its Q2 2024 earnings report on July 30.

Merck & Co., Inc.

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