Elanco Achieves Important Innovation Milestones, Momentum to Start 2021

Rhea-AI Summary

Elanco Animal Health (NYSE: ELAN) has announced significant innovation milestones, including two crucial product approvals. The U.S. FDA approved Increxxa™ for treating bovine and swine respiratory diseases, while Health Canada approved Experior™ 50, the first animal health product aimed at reducing ammonia emissions. In Europe, positive progress was made for Credelio Plus Chewable tablets, and Credelio CAT is expected to receive FDA approval soon. These advancements are expected to drive Elanco's growth, with an anticipated $500-$600 million in new product revenues by 2025.

Positive

• Increxxa™ approved for bovine and swine respiratory diseases by U.S. FDA.
• Experior™ 50 approved in Canada to reduce ammonia emissions in livestock.
• Credelio Plus receives positive opinion for marketing authorization in Europe.
• Credelio CAT expected to gain FDA approval in Q2, enhancing pet health portfolio.
• Projected $500-$600 million in new product revenues by 2025.

Negative

• None.

Elanco Animal Health Incorporated (NYSE: ELAN) today announces four important innovation milestones, including two product approvals, amid a string of recent progress on its innovation commitments.

Farm Animal

• Yesterday, the U.S. FDA approved Increxxa™ (tulathromycin injection) for the treatment of bovine respiratory disease (BRD) and swine respiratory disease (SRD).
• Earlier this week, Health Canada approved Experior™ 50, (lubabegron), a new concentration of Experior for the reduction of ammonia gas emissions per kilogram of live weight and hot carcass weight during the last 14 to 91 days on feed, representing the first animal health product with proven environmental benefit.

Pet Health

• In Europe, the Committee for Medicinal Products for Veterinary Use (CVMP), a part of the European Medicines Agency (EMA) delivered a positive opinion yesterday on the granting of a Community marketing authorization for Credelio Plus Chewable tablets for dogs (lotilaner/milbemycine oxyme). This opinion will be sent to the European Commission for adoption and granting of the marketing authorization.
• Also yesterday, Elanco received the final technical section complete letters from the U.S. FDA for Credelio™ CAT (lotilaner), anticipated to be the first oral flea and tick treatment to be licensed for cats, with product approval expected in the second quarter.

Innovation is a key driver of Elanco’s long-term growth algorithm, expected to contribute 2 to 3 percentage points of top-line average annual growth in the coming years. At its December Investor Day, the company committed to eight product launches in 2021, anticipated to generate $80 million to $100 million in new product revenue, setting the foundation for an expected $500 to $600 million in new product revenues by 2025.

The Canadian approval of Experior and U.S. approval of Increxxa mean Elanco has now received nine of the 13 geographic approvals associated with its eight expected key launches in 2021. In addition to needing the final nods for Credelio for Cats and Credelio Plus in Europe, the company also anticipates Credelio Plus will gain approval in Australia and Cosabody in Europe later this year.

“We are pleased with the significant progress and momentum these milestones represent in our pipeline,” said Aaron Schacht, executive vice president, Innovation, Regulatory and Business Development at Elanco. “Several of these products represent first-in-class or best-in-class solutions for customers' unmet needs for the benefit of animals, people and the planet.”

Increxxa and Experior bring important tools to the livestock industry. Respiratory disease is a significant challenge for the livestock industry and a significant contribution to mortality¹²³. Increxxa, already approved in Europe, is a valuable complement to our existing U.S. Farm Animal respiratory care portfolio for veterinarians and producers, equipping them with another solution to help combat this problematic disease in cattle and swine. Meanwhile, Experior is a first of its kind product that provides feedlot managers with the freedom and flexibility to balance environmental stewardship and sustainability while delivering business results. With the addition of Experior 50, we are meeting the unique needs of Canadian cattleman.

In our pet portfolio, we continue to expand the Credelio franchise. Credelio Plus, already available for dogs in Japan, is a unique combination of the active ingredient lotilaner for safe, fast-acting and powerful protection against ticks and fleas, with the trusted active ingredient milbemycin oxime for common parasitic worms that affect dogs – heartworm and intestinal worms. The all-in-one preventive comes in a small meat-flavored chewable tablet safe for puppies as young as 8 weeks. In cats, the FDA notification means Credelio CAT is expected to soon be commercially available in the United States, following its successful launch in Europe, bringing cat owners the safe, convenient flea and tick control dog owners have already come to enjoy.

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/ESG Pledges –all to advance the health of animals, people, and the planet. Learn more at elanco.com.

Forward Looking Statements

This press release may include certain statements concerning expectations for the future that are forward-looking statements as defined by federal securities law. Such forward-looking statements are subject to a variety of known and unknown risks, uncertainties, and other factors that are difficult to predict and many of which are beyond management’s control. These risks and assumptions are described in Elanco’s annual reports on Form 10-K and other reports that are available from the U.S. Securities and Exchange Commission. Readers are cautioned not to place undue reliance on forward-looking statements, which reflect management’s view only as of the date made. We undertake no obligation to update any forward-looking statement, except as otherwise required by law.

---

¹ USDA Feedlot 2011 Part IV- “Health and health management on U.S. feedlots with a capacity of 1,000 or more” (v1.0)

² Hilton WM Animal Health Research Reviews 2014 120 (v1.0)

³ Qin, S., et al. 2018. “Viral communities associated with porcine respiratory disease complex in intensive commercial farms in Sichuan province, China.” Sci. Rep. 8, 13341. doi:10.1038/s41598-018-31554-8

View source version on businesswire.com: https://www.businesswire.com/news/home/20210219005119/en/

FAQ

What recent product approvals did Elanco announce?

Elanco announced the FDA approval of Increxxa™ for respiratory diseases in livestock and Health Canada's approval of Experior™ 50, which reduces ammonia emissions.

What future projections does Elanco have regarding new product revenues?

Elanco anticipates generating $500 to $600 million in new product revenues by 2025.

When is Credelio CAT expected to receive FDA approval?

Credelio CAT is expected to gain FDA approval in the second quarter.

How do these product approvals impact Elanco's growth strategy?

These approvals are part of Elanco's growth strategy, contributing 2 to 3 percentage points to annual sales growth.

What is the significance of the approval of Experior™ 50?

Experior™ 50 is significant as it is the first animal health product with proven environmental benefits, aimed at improving sustainability in livestock management.