Core Insights - Elanco Animal Health has received approval from the European Commission for Zenrelia™ (ilunocitinib), marking a significant milestone in the EU canine dermatology market [1][2][3] Group 1: Product Approval and Market Impact - Zenrelia is recognized as a highly effective, convenient, and safe once-daily oral JAK inhibitor for controlling pruritus associated with allergic dermatitis and atopic dermatitis in dogs aged at least 12 months [2][3] - The approval reinforces Elanco's position as a leader in pet health innovation and is expected to enhance the treatment options available for veterinarians and pet owners in Europe [3][4] Group 2: Clinical Study and Efficacy - A head-to-head non-inferiority study against the market leader, Apoquel, involved 338 client-owned dogs and demonstrated that Zenrelia is at least as effective as the incumbent JAK inhibitor at the primary endpoint on Day 28 [4] - The study results have been published in the peer-reviewed journal Veterinary Dermatology, further validating the product's efficacy [4] Group 3: Commercial Strategy and Launch - Elanco's commercial teams are prepared for an immediate product launch, with supply availability expected in the third quarter of 2025 [4][8] - Zenrelia will join Elanco's growing pet health portfolio in Europe, which includes other products like AdTab, Credelio, and Galliprant [4]

Financial Data and Key Metrics Changes - Fourth quarter revenue was $1.02 billion, representing a 1% reported decline, but organic constant currency growth was 4% [46] - Adjusted EBITDA for the fourth quarter was $177 million, an increase of $12 million on a reported basis [54] - Full year adjusted EPS came in at $0.91 compared to $0.89 in 2023, reflecting a year-over-year growth [58] Business Line Data and Key Metrics Changes - Total Pet Health revenue increased 6% in constant currency in the fourth quarter, with U.S. Pet Health growing 2% and international Pet Health growing 11% [47][48] - U.S. Farm Animal business achieved $223 million in sales, a 6% increase, driven by cattle market expansion [49] - International Farm Animal revenue was flat, impacted by the Kexxtone recall and strategic changes in certain geographies [50] Market Data and Key Metrics Changes - The U.S. dermatology market is projected to surpass $2 billion, with Zenrelia capturing significant market share [80] - The global carbon market for Bovaer is estimated to be $2 billion, with strong demand from farmers [38] - The U.S. dairy farmers earned approximately $10 million in credits from using Rumensin in the fourth quarter [39] Company Strategy and Development Direction - The company is focused on growth, innovation, and cash generation, with expectations for 2025 organic constant currency revenue growth of 4% to 6% [12][73] - Strategic divestiture of the aqua business has allowed for debt reduction and increased investments in product launches [10][20] - The company aims to leverage its comprehensive portfolio to enhance market share in both Pet Health and Farm Animal sectors [22][24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in accelerating fundamentals for 2025, despite challenges from foreign exchange impacts [14][72] - The company anticipates continued growth from innovation and a stabilization of its base business [13][42] - Management highlighted the importance of effective commercial execution and the positive reception of new product launches [72] Other Important Information - The company achieved a net leverage ratio of 4.3 times at the end of the year, down from 5.6 times at the start of 2024 [20] - The company launched five new U.S. product approvals in 2024, contributing to a robust innovation pipeline [28] - The company expects adjusted EBITDA for 2025 to be between $830 million and $870 million, factoring in foreign exchange headwinds [64] Q&A Session Summary Question: What is the expected penetration of Zenrelia by year-end 2025? - Management indicated that Zenrelia is experiencing strong adoption, with a focus on increasing clinic penetration through aggressive sampling and direct-to-consumer efforts [81][84] Question: What factors contribute to the accelerating revenue growth in Q1 2025? - Management noted that the growth is driven by the ramp-up of Zenrelia and Credelio Quattro, alongside the absence of headwinds faced in the previous year [88][89] Question: What gives confidence in the innovation contribution for 2025? - Management highlighted strong momentum from products like Experior and AdTab, as well as the growth potential in the dermatology market with Zenrelia and Quattro [96][97] Question: How is the early launch of Credelio Quattro performing? - Management reported positive initial momentum, with strong veterinarian interest and a comprehensive commercialization strategy in place [115][116] Question: What are the dynamics behind the surge in Galliprant sales? - Management attributed the surge to its strong safety profile and effective marketing strategies, expecting continued performance into 2025 [120] Question: How does the company view the competitive environment in dermatology? - Management acknowledged competition as a headwind but emphasized the growing market and unmet needs that present opportunities for growth [125][126]