Elanco Announces Credelio Quattro Moves to Final FDA Administrative Review

Company's broad spectrum parasiticide on-track for October U.S. approval and first quarter 2025 launch

GREENFIELD, Ind., Aug. 20, 2024 /PRNewswire/ -- Elanco Animal Health Incorporated (NYSE: ELAN) today announced the U.S. Food and Drug Administration (FDA) has completed its review of all major and minor technical sections for Credelio Quattro, and the final 60-day administrative review is underway.

"This is an exciting time at Elanco as we deliver a robust innovation portfolio that we believe will help transform animal care with solutions that go beyond today's market leaders," said Jeff Simmons, Elanco President and CEO. "Elanco expects to launch a potential blockbuster each of the next three quarters in large, fast-growing or new markets that are largely accretive to Elanco. We continue to expect $600 million to $700 million of innovation sales in 2025."

The Company continues to expect Credelio Quattro to be positively differentiated and is seeking approval for indications that would give the broadest parasite coverage including fleas, ticks, heartworms and other internal parasites, like tapeworm. In addition to the regulatory process, the company is finalizing the manufacturing scale-up to optimize launch, targeted for the first quarter of 2025.

"We are very pleased with the continued progress of our pipeline," said Dr. Ellen de Brabander, Executive Vice President of Innovation and Regulatory Affairs. "We completed the Bovaer review ahead of schedule and now have two potential blockbusters – Zenrelia and Credelio Quattro – in the final administrative review at FDA, illustrating our R&D organization's high capacity and ability to build capabilities to deliver a consistent flow of high impact innovation. A significant thank you to the Elanco team for their efforts to bring these differentiated innovations toward approval while also refilling and advancing the early-stage pipeline for the next era of innovation."

The FDA has the legal authority to approve and regulate drugs for both people and animals. FDA's Center for Veterinary Medicine (CVM) approves and regulates new animal drugs. The approval process includes up to five major technical sections (Target Animal Safety; Effectiveness; Chemistry, Manufacturing, and Controls; Human Food Safety (farm animal products); and Environmental Impact (farm animal products) and two minor technical sections (All Other Information and Labeling)). Once all the major and minor technical sections are complete, the drug sponsor submits the New Animal Drug Application (NADA), for the final administrative review. For more information about the FDA approval process, please visit: https://www.fda.gov/animal-veterinary/animal-health-literacy/idea-marketplace-journey-animal-drug-through-approval-process.

ABOUT ELANCO

Elanco Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders and society as a whole. With nearly 70 years of animal health heritage, we are committed to helping our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our Elanco Healthy Purpose™ sustainability pillars – all to advance the health of animals, people, the planet and our enterprise. Learn more at www.elanco.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the federal securities laws, including, without limitation, statements concerning product approvals and launches and revenue from such products

Forward-looking statements are based on our current expectations and assumptions regarding our business, the economy and other future conditions. Because forward-looking statements relate to the future, by their nature, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. As a result, our actual results may differ materially from those contemplated by the forward-looking statements. Important risk factors that could cause actual results to differ materially from those in the forward-looking statements include regional, national or global political, economic, business, competitive, market and regulatory conditions, including but not limited to operating in a highly competitive industry; the success of our research and development (R&D) and licensing efforts; the impact of disruptive innovations; competition from generic products; an outbreak of infectious disease carried by farm animals; risks related to the evaluation of animals; consolidation of our customers and distributors; the impact of increased or decreased sales into our distribution channels; our dependence on the success of our top products; our ability to complete acquisitions and divestitures and successfully integrate the businesses we acquire; our ability to implement our business strategies or achieve targeted cost efficiencies and gross margin improvements; manufacturing problems and capacity imbalances; fluctuations in inventory levels in our distribution channels; the impact of weather conditions, including those related to climate change, and the availability of natural resources; the effects of a human disease outbreak, epidemic, pandemic or other widespread public health concern; the loss of key personnel or highly skilled employees; adverse effects of labor disputes, strikes and/or work stoppages; the effect of our substantial indebtedness on our business; changes in interest rates; risks related to the write-down of goodwill or identifiable intangible assets; the lack of availability or significant increases in the cost of raw materials; risks related to our presence in foreign markets; risks related to currency rate fluctuations; risks related to underfunded pension plan liabilities; the potential impact that actions by activist shareholders could have on the pursuit of our business strategies; actions by regulatory bodies, including as a result of their interpretation of studies on product safety; the possible slowing or cessation of acceptance and/or adoption of our farm animal sustainability initiatives; the impact of increased regulation or decreased governmental financial support related to the raising, processing or consumption of farm animals; the impact of litigation, regulatory investigations, and other legal matters, including the risk to our reputation; challenges to our intellectual property rights or our alleged violation of rights of others; misuse, off-label or counterfeiting use of our products; unanticipated safety, quality or efficacy concerns and the impact of identified concerns associated with our products.  For additional information about these and other factors that could cause actual results to differ materially from forward-looking statements, please see the Risk Factors in the company's latest Form 10-K and Form 10-Qs filed with the Securities and Exchange Commission. Although we have attempted to identify important risk factors, there may be other risk factors not presently known to us or that we presently believe are not material that could cause actual results and developments to differ materially from those made in or suggested by the forward-looking statements contained in this press release. Any forward-looking statement made by us in this press release speaks only as of the date thereof. We undertake no obligation to publicly update or to revise any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Additional Information

We define innovation revenue as revenue from new products, lifecycle management and certain geographic expansions and business development transactions that is incremental in reference to product revenue in 2020 and does not include the expected impact of cannibalization on the base portfolio.

Investor Contact: Kathryn Grissom, +1.317.273.9284, [e-mail]

Media Contact: Colleen Parr Dekker, +1.317.989.7011, [e-mail]

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