Jeffrey Simmons
Analyst · Stifel. Your line is open
Thanks, Tiffany. Good morning, everyone. Elanco exceeded first quarter guidance for revenue, adjusted EBITDA and adjusted EPS. Continuing our momentum from the end of 2024, we have delivered a high-quality quarter with 4% organic constant currency revenue growth, evenly driven by price and volume. This strong Q1 performance represents our seventh quarter of underlying growth. On innovation, after delivering $198 million of first quarter revenue from our new products, we are raising our full year expectations to $660 million to $740 million. We are pleased by the commercialization of our basket of six potential blockbusters with the most recently launched product, Credelio Quattro off to a great start surpassing our expectations to date. With a relentless focus on cash, we are deleveraging faster than planned, improving our net leverage target for year-end to 3.9x to 4.3x, reflecting strong working capital performance, favorable currency and the monetization of our Lotilaner U.S. Royalties stream for $295 million that we announced earlier this week. Looking ahead, we have raised our 2025 full year revenue guidance for FX, and we are maintaining our outlook for organic constant currency growth of 4% to 6%. We continue to expect accelerating quarter-on-quarter growth with Q2 up 4% to 6%. March and April trends have provided early proof points and innovation continues to ramp on top of a strong base business. We also continue to expect full year adjusted EBITDA of $830 million to $870 million and adjusted EPS of $0.80 to $0.86. The Elanco strategy is working and offsetting external uncertainty. Our prudent approach recognizes our first quarter outperformance, recent momentum and favorable FX, balanced by expected tariff impact in a dynamic macroeconomic backdrop. Our execution in our One Elanco global operating model give us the agility needed to cover various scenarios that may emerge in this external environment, including tariff and trade impacts, regulatory and policy changes and shifts in the consumer sentiment and spending. We have a dedicated team implementing a multifaceted intervention plans to allow us to deliver even during these turbulent times, and we will remain focused on growth, innovation and cash as the right priorities to expand our long-term value proposition. Let's take a moment to walk through how we're covering our expected tariff exposure on Slide 5. You'll remember that with our late February call, we outlined $3 million to $4 million of potential impact from the first 10% imposed on China. We would strongly caution against extrapolating that impact to the 145% imposed today without also considering the pharmaceutical exemption and our intervention plans already in action. Since late February, we've begun implementing several mitigating strategies, including supply chain optimization, inventory management, tactical pricing in select geographies and strategic API sourcing. We believe the total net impact in 2025 to Elanco adjusted EBITDA from tariffs as they stand as of May 5, is an estimated $16 million to $20 million, almost entirely related to the tariffs imposed by the U.S. and China. This negative impact is fully offset by our first quarter outperformance as we are maintaining our full year adjusted EBITDA and adjusted EPS guidance. We have a balanced profile of risks and further mitigating strategies, also allowing for maintained guidance. While we benefit from the pharma exemption today, if this policy is removed and a 5% to 25% tariff is imposed, we estimate our incremental exposure at $10 million to $30 million in 2025. This risk and others, including potential economic slowdown are offset by anticipated foreign exchange favorability based on April rates and a targeted value-based pricing increase. Elanco is well positioned to overcome macroeconomic challenges and uncertainty to deliver our plan. Turning to the first quarter revenue performance on Slide 6. We break down the 4% underlying organic constant currency revenue growth. This chart highlights the importance of our diverse portfolio with three of our four business areas growing. We achieved the top end of our expected growth range in Q1 despite the challenging U.S. retail backdrop in January and February. Our U.S. retail business declined 21% during that 2-month period driven by cooler weather that significantly impacted consumer spending. January was the coldest on record since 1988. Tick bites reported by the CDC, tracked at an 8-year low. Importantly, retailers have broadly observed that when the weather cooperates, consumers engage, citing better trends into the spring. Our results support this with March rebounding to a positive 13% growth and strength carrying into April as we enter the heart of the North American parasiticide season. Our leadership in the U.S. retail market has never been more relevant with the consumer under pressure. We provide a superior value proposition for pet owners with our strong OTC portfolio and broad physical availability in the U.S. vet clinic, our revenue was flat in the quarter. Importantly, as we discussed on our earnings call a year ago, we are lapping an approximate $13 million benefit related to moving certain legacy Bayer products into distribution. Excluding this impact in the comparison, our Vet clinic revenue growth would be approximately 8%. We benefited from the early and ramping contributions from Credelio Quattro and Zenrelia, which I will cover more in depth shortly. Altogether, we see a rebounding retail environment, good early traction for innovation and a solid underlying fundamentals in our portfolio all driving our expectation for U.S. pet health to return to a step up in growth in Q2. Moving now to international pet health. We delivered 5% organic constant currency revenue growth, driven by AdTab, Credelio and Seresto. Our international pet health business remains a clear example of the value of innovation with new products driving two percentage points of growth for total Elanco in the quarter. Specifically, AdTab more than doubled its revenue in the first quarter compared to last year, and we continue to be very pleased with Zenrelia's performance in Brazil, Canada and Japan. The power of innovation and a diverse portfolio is also clear in the U.S. farm animal business, up 17% with continued strength in cattle. Experior again led the way with rapid adoption in heifers since we received FDA combo clearance in November. International Farm was up 2% in organic constant currency, with growth in ruminants, partly offset by the impact of Kexxtone recall and our commercial model changes in certain geographies from last year. We estimate these two items created a combined four percentage point headwind to our year-over-year growth. Looking at Slide 7, we delivered $198 million of innovation revenue in the first quarter. This outperformance with growing momentum from our Big 6 portfolio of potential blockbusters leads us to increase our expected innovation contribution for 2025 by $20 million at both ends of the range to $660 million to $740 million. We expect a consistent flow of high-impact innovation to fuel our growth for the next decade through targeted areas, including our monoclonal antibody platform. In the near term, we continue to expect this platform to deliver our IL-31 approval in the fourth quarter of this year with commercialization in the first half of 2026. We remain in close dialogue with the USDA, where we believe recent changes have not materially impacted the review team and process. Let's dig deeper on the progress of these six products on Slide 8, starting with Zenrelia. Zenrelia is our entry into the $1.9 billion rapidly growing global dermatology market, and it continues to make meaningful strides in clinic penetration. Zenrelia is now used in approximately 11,000 U.S. vet clinics or 35% of the total, up from 8,000 total clinics when we updated you in late February. Of this 11,000 today, about 8,000 have fully adopted the product and about 3,000 are piloting use. And in line with positive trends broadly across our U.S. pet health business, we're encouraged by the progression of the Zenrelia sales. Importantly, as vets experienced the strong and consistent efficacy of the product firsthand, they are responding. One in three clinics that have received samples has purchased Zenrelia and integrated it into their derm portfolios. Our reorder rates have climbed to 70%, up approximately 10 percentage points since late February, and we expect continued momentum as we've entered the allergy season. Our survey work shows that 26% of vets not using Zenrelia today expect to use it in the future, with the majority of that cohort citing, seasonal allergies and frustrations with current options. Customers are responding to with broadly positive reviews applauding the efficacy, convenience and the value of the product. We are continuing with targeted outreach to pet owners, and we are increasing our focus on tech to tax sessions which have proven to be highly effective. The biggest challenge we face in the U.S. for Zenrelia is moving beyond second-line treatment, where it has been positioned in various clinics. Also, we are actively engaged in the process to update the U.S. label. Data supporting a language change on the current label is already under CDM review, and we expect to receive feedback later this year. In addition, we've already initiated new studies for a more comprehensive label change. Overall, we continue our robust engagement with the FDA, and we will keep you updated with our progress on both fronts. Outside the U.S., where we have less restrictive labels, we are very pleased with the launch of Zenrelia in Brazil, Canada and Japan, which is a great start to capturing share in the $600 million to $700 million international dermatology market. Brazil, the first international market to launch has outperformed our initial expectations for both penetration and sales with efficacy being a key driver for switching to Zenrelia. We continue to expect approvals in Europe, the U.K. and Australia this year. Moving to Credelio Quattro. We launched and shipped product in January ahead of the parasiticide season. We are very encouraged by the early results with share capture ahead of expectations while cannibalization has also been favorable to our assumptions. In a span of just a few short months, we've already achieved approximately 10% dollar share of broad spectrum sales in the U.S. Fed clinics. Approximately 2/3 of share capture has come from competitive broad spectrum and DECCO products or new starts, highlighting the high veterinary interest in Credelio Quattro's differentiated profile. All of our distributors have ordered multiple times within the quarter, and inventories at distribution are still running relatively lean. We attribute our initial success to strong vet response to the three dimensions of differentiation for Credelio Quattro. First, broad coverage, including multiple species of tape arms, the speed of tick kill and heartworm coverage from month 1. Both vet clinics and pet owners have proactively shared how pleased they are with the palatability of Credelio Quattro to dogs. Having seen this robust clinic demand, we're now increasing DTC investment to activate even more pet owners. We're also preparing for a global launch with approval submissions made in Australia, Canada and Japan. In Europe, our pet health business has been led by the strength of AdTab, our OTC flea and tick product for both dogs and cats. We have seen accelerating growth, doubling sales year-over-year with a clear runway for further gains. AdTab was approved and launched in the U.K. in April, and we are strategically increasing brand-building DTC in the second quarter beyond our initial expectations, reflecting the attractive returns we're seeing on our investment. AdTab is quickly gaining share, and we're also seeing minimal cannibalization of our existing portfolio. Finally, in pet health, our canine parvovirus monoclonal antibody is the first and only USDA conditionally approved treatment for Parvo. Making CPMA widely available is crucial in our fight against this devastating virus including in shelter environments where resources are often strained. We are focused on increasing access to this life-saving treatment, and we continue to explore strategic interventions to address the cost of treatment and to accelerate clinic penetration across all channels. In farm animal, Experior continues to rapidly grow in a market, which we now estimate has potential size of over $350 million in the U.S. and Canada with other additional international expansion opportunities. We have unlocked more of this market for Experior through the benefit of the U.S. heifer clearance in November. We are confident in Experior's growth trajectory in the U.S. and Canada and the product's continued ability to drive overall portfolio benefits. Lastly, with respect to Bovaer, we remain encouraged by the strong demand from dairy farmers and CPGs. Since February, we've doubled the number of cows on the product. However, adoption in our margins have been impacted near term as government incentives have not yet been released. Moving forward to optimize Bovaer's economic value and to enhance dairy farmer flexibility, we intend to expand our label as well as lower manufacturing costs. Importantly, the Bovaer demand is robust with April being our most significant month of new cows starting while customer retention is high, consistent with farm animal feeding like Experior. We do believe that Bovaer can become another farm animal Elanco blockbuster and create the next major market in farm animal health. Overall, the basket of the Big 6 innovations is outperforming and driving accelerating growth for the entire company. Moving to Slide 9. We highlight all three elements of our IPP or innovation, portfolio and productivity strategy. Our innovation builds on our portfolio, which remains a key source of our resilience, enabling this robust growth even in challenging times. Our diverse durable product portfolio is balanced across geographies and species. In U.S. pet health, we gained share in each of the four key markets in our comprehensive portfolio, para, NSAIDs, derm and vaccines. Fed clinics prioritize partners who offer a complete set of solutions, allowing us to leverage innovation to lift our broader pet health portfolio. As an example, over 500 U.S. clinics that adopted Credelio Quattro in Q1 also bought for the first time other Elanco products. In U.S. farm animal, we continue to build on our market leadership and targeted innovations like Pradalex, a treatment for bovine and swine respiratory disease conveniently given as a one low-volume shot bolstering our wide portfolio of solutions. Finally, on productivity, earlier this week, we announced the monetization of our Lotilaner milestones and U.S. Royalties for $295 million. This is a great example of Elanco pioneering new value streams and translating animal health into human health. Monetizing this noncore part of our portfolio accelerates our deleveraging objective. The transaction combined with our more favorable foreign exchange rates positively impacting our cash balances and additional improvements in working capital is driving our net leverage target for 2025 down to 3.9x to 4.3x adjusted EBITDA. We also remain focused on the cost discipline as an element within our control in this challenging macro backdrop while we still strategically continue to invest in our innovation product launches and the expansion of our Elwood, Kansas and Fort Dodge, Iowa facilities, which are progressing as planned. Our ongoing company-wide productivity agenda was further evidenced by the gross margin expansion in the quarter, driven by better-than-expected manufacturing performance with good management of absorption, losses and expenses. With that, I'll pass it to Todd to provide more on the first quarter results and financial guidance.