FDA approves expanded Credelio products for Lyme disease prevention

INDIANAPOLIS - Elanco Animal Health Incorporated (NYSE:ELAN), a leading animal health company with a market capitalization of $10.95 billion and strong financial health according to InvestingPro metrics, announced Monday that the FDA has approved expanded labels for two of its canine prescription parasiticides, Credelio Quattro and Credelio, to include prevention of Lyme disease and protection against longhorned ticks.

The label expansions come as tick-borne diseases are on the rise, with the Companion Animal Parasite Council reporting more than 422,000 cases of Lyme disease in dogs so far this year, exceeding the total number of cases seen in all of 2019.

Both products now include claims for prevention of Lyme disease as a direct result of killing black-legged ticks (Ixodes scapularis), which are primary vectors for the disease. The labels also now include treatment and control of longhorned tick (Haemaphysalis longicornis) infestations, an invasive species that has spread to 22 states. This expansion could further strengthen Elanco’s market position, with the company already maintaining a healthy gross profit margin of 54.73% and demonstrating strong liquidity with a current ratio of 2.6.

"With this label expansion, pet owners and veterinarians now have more options to protect dogs from Lyme disease," said Dr. Casey Locklear, veterinarian and parasiticide lead for Elanco Animal Health, according to the press release.

In a peer-reviewed study published in Parasites and Vectors, both products demonstrated 100% efficacy against the longhorned tick at 48 hours after infestation, with protection continuing throughout the month.

The products contain lotilaner, which has been found effective for killing black-legged ticks. Northeast states including New York, Maine, New Hampshire, Vermont, Pennsylvania and Connecticut are among those with the most positive Lyme disease cases in dogs.

Both medications are prescription products for dogs and puppies 8 weeks of age and older, with specific weight requirements varying by product. Elanco’s stock has shown remarkable performance, trading near its 52-week high with a 72.6% return over the past year. For detailed analysis and additional insights, including 12 more exclusive ProTips, check out the comprehensive research report available on InvestingPro.

In other recent news, Elanco Animal Health Incorporated has received the first-ever Emergency Use Authorization from the U.S. Food and Drug Administration for treating New World screwworm infestations in dogs with its oral medication, Credelio. This development comes amid confirmed cases of the parasite near the U.S.-Mexico border. Additionally, Moody’s Ratings has upgraded Elanco’s corporate family rating to Ba2, citing improved product uptake and ongoing debt reduction. S&P Global Ratings also upgraded Elanco to ’BB’ from ’BB-’ due to the company’s efforts to lower its leverage, highlighted by significant debt repayment through various means, including divestitures and cash flow.

JPMorgan has upgraded Elanco’s stock to Overweight, recognizing the company’s entry into an attractive innovation cycle with products like Credelio Quattro gaining market traction. Stifel has also raised its price target for Elanco to $23, driven by strong product growth, particularly in the U.S. market share of Credelio Quattro. These recent developments reflect Elanco’s strategic advancements and market positioning.

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