Elanco Animal Health Inc
NYSE:ELAN
If you don’t study any companies, you have the same success buying stocks as you do in a poker game if you bet without looking at your cards.
Utilize notes to systematically review your investment decisions. By reflecting on past outcomes, you can discern effective strategies and identify those that underperformed. This continuous feedback loop enables you to adapt and refine your approach, optimizing for future success.
Each note serves as a learning point, offering insights into your decision-making processes. Over time, you'll accumulate a personalized database of knowledge, enhancing your ability to make informed decisions quickly and effectively.
With a comprehensive record of your investment history at your fingertips, you can compare current opportunities against past experiences. This not only bolsters your confidence but also ensures that each decision is grounded in a well-documented rationale.
Do you really want to delete this note?
This action cannot be undone.
| 52 Week Range |
11.78
18.45
|
| Price Target |
|
We'll email you a reminder when the closing price reaches USD.
Choose the stock you wish to monitor with a price alert.
This alert will be permanently deleted.
Elanco Animal Health Inc
Earnings Call Analysis
Q3-2024 Analysis
Elanco Animal Health Inc
In the third quarter of 2024, Elanco Animal Health reported solid performance, achieving constant currency organic revenue growth of 1%. The $1.03 billion in revenue represented a decline of 4% when accounting for foreign exchange impact and the divestiture of the Aqua business. Price increases accounted for 2% growth, offsetting a 1% decline in volume. Notably, the company has now seen five consecutive quarters of underlying growth, demonstrating resilience in its product portfolio.
Elanco has raised its expectations for organic revenue growth in 2024 to about 3%. The company anticipates further acceleration in growth moving into the fourth quarter and into 2025. Key drivers behind this optimism include the success of new product launches such as Zenrelia, Credelio Quattro, and solid ongoing performance from existing products like Experior and AdTab.
Elanco's strategy hinges on innovation, with a strong pipeline of new products expected to generate $600 million to $700 million in revenue in 2025. The company has confidence in driving mid-single-digit organic growth for the same year, bolstered by recent FDA approvals and market entries of new products. Zenrelia is expected to significantly penetrate the canine health market, while Credelio Quattro aims to fill gaps in parasiticide offerings.
Despite these advancements, Elanco faces pressures from competitive dynamics, particularly within the U.S. pet health market. A decline in U.S. business by 4% was attributed to supply chain volatility and competitive pressure, reflecting broader market challenges. However, Elanco's growth in international markets, driven by products like AdTab and Seresto, was a bright spot, where constant currency revenue in Europe increased by 2%.
Financially, Elanco has made strides in debt management, reducing its net leverage from mid-5x to a projected mid-4x by year-end 2024. This includes a substantial $1.3 billion debt reduction enabled by the Aqua divestiture. The company's strategic focus on managing operating expenses and interest costs indicates a path to improved financial health, with expectations for reduced cash interest payments in 2024.
For the full year 2024, Elanco has narrowed its revenue guidance range to between $4.42 billion and $4.45 billion, reflecting the anticipated headwinds from foreign exchanges and the Aqua divestiture. Adjusted EBITDA is expected in the range of $900 million to $930 million, and adjusted EPS is predicted to fall between $0.89 and $0.95. These metrics combine lower operational efficiencies in the short term with a clear pivot towards innovative growth.
As Elanco approaches 2025, the focus will shift towards leveraging its innovative product launches. The company aims to address challenges by enhancing its market penetration strategies and optimizing operational performance. Although growth in adjusted EBITDA is expected to be low single digits in 2025, primarily influenced by recent disruptions in the UK CMO supplier, Elanco anticipates long-term profitability improvements as the full benefits of innovation take center stage.
You don't have any saved screeners yet
Ladies and gentlemen, thank you for standing by. Welcome to Elanco Animal Health Third Quarter 2024 Earnings Conference Call. [Operator Instructions] Thank you. I would now like to hand the call over to Katy Grissom, Head of Investor Relations. You may begin your conference.
Head of Investor Relations and ESG. Joining us on today's call are Jeff Simmons, our President and Chief Executive Officer; Todd Young, our Chief Financial Officer; and Beth Haney from Investor Relations. The slides referenced during this call are available on the Investor Relations section of elanco.com. Today's discussion will include forward-looking statements. These statements are based on our current assumptions and expectations and are subject to risks and uncertainties that could cause actual results to differ materially from our forecast.
For more information, see the risk factors in today's earnings press release as well as our latest Form 10-K and 10-Q filed with the SEC. We do not undertake any duty to update any forward-looking statements. The information we provide about our products and pipeline is for the benefit of the investment community. It is not intended to be promotional, and it is not sufficient for prescribing decisions.
Our remarks today will focus on our non-GAAP financial measures. Reconciliations of these non-GAAP measures are included in the appendix of today's slides and in the earnings press release. After our prepared remarks, we will be happy to take your questions. I'll now turn the call over to Jeff.
Thanks, Katy. Good morning, everyone. Elanco reported a strong third quarter, delivering constant currency organic top line growth with adjusted EBITDA and adjusted EPS above the midpoint of our guidance ranges. Organic constant currency revenue growth of 1% was driven by the contribution from new products, led by Experior, AdTab, Credelio Plus and Zenrelia. This marks our fifth consecutive quarter of growth in our underlying business, and we continue to expect to deliver constant currency organic revenue growth of about 3% in 2024.
Our consistent strategy focused on growth, innovation and cash is paying off with innovative new products driving growth, enabling improved cash flow. Beginning on Slide 4, we achieved key milestones advancing our innovation, portfolio and productivity strategy. Third quarter revenue growth, excluding the impact of our Aqua divestiture was led by our U.S. farm and international pet health businesses.
For Elanco, overall, we expect organic growth to accelerate sequentially in the fourth quarter and into next year. Since our last earnings call, we achieved several milestones for key potential blockbuster products as we now shift from regulatory into commercial launch mode. On the pet health side, we received U.S. FDA approval for both Zenrelia and Credelio Quattro positively differentiated products expected to be meaningful competitors in the 2 largest markets in pet health. On the farm side, Bovaer saw the first on-farm feeding into dairy house, the flywheel is beginning to move as multiple consumer packaged good companies have signed contracts to purchase in-set carbon credits from Appian derived from the use of Bovaer to reduce methane emission from dairy cows. As we shared in August, we paid down $1.3 billion of debt in the third quarter, enabled by the divestiture of our Aqua business.
Debt paydown remains our top capital allocation priority and net leverage down from the mid-5x at the start of the year, now expected to be in the mid-4x range at the end of this year. Finally, today, we're introducing a framework around our 2025 expectations, with continued confidence in our expected $600 million to $700 million of revenue from new products, we expect 2025 organic constant currency growth to accelerate to mid-single digits in 2025. We expect the underlying business to drive mid-single-digit adjusted EBITDA growth excluding the Aqua divestiture as we invest strategically in our new pet health launches.
Ultimately, we expect organic adjusted EBITDA to grow low single digits driven by an expected headwind from the court supervised and solvency of 1 of our key CMOs located in the U.K. We continue to expect year-end net leverage to be in the low 4% to high 3x range. Todd will further address our outlook towards the end of our prepared remarks. Moving to Slide 5. We provide third quarter year-over-year revenue growth by our 4 business areas. We've separated out the impact of the Aqua divestiture to show the underlying organic constant currency growth of 1%.
First, starting with the U.S. Pet Health revenue, which declined 4% in the quarter as strong retail performance was more than offset by competitive pressure and vaccine supply volatility in the vet clinic. On the retail side, the business returned to growth as the positive dispensing trends we saw starting in May continued in the third quarter. U.S. Seresto sales grew over 20% in the third quarter, driven all by volume. On the vet side, we're excited about the launch of Zenrelia in the third quarter and the expected first quarter 2025 launch of Credelio Quattro.
These products will be key contributors to the U.S. pet business expected return to growth in the fourth quarter of this year and into 2025. Outside the U.S., Pet Health delivered constant currency revenue growth of 2%, driven by the continued strength of AdTab Credelio Plus and Seresto. ADTab has exceeded our expectations each quarter this year as our source of volume analysis points to less cannibalization of our existing portfolio in both fat and retail channels. Our strategic investment in the brand is driving AdTab to lead category growth for both dogs and cats, recruiting more new users into the fast-growing oral over-the-counter market than competitors.
Across markets in Europe, we are seeing significant penetration in key channels and very high reorder rates, while positive consumer preference survey data supports continued brand-building investment. We expect ADTab to be a key growth driver in 2025 as well. Now moving to farm animal grew revenue 3% globally. The U.S. business grew 11%, led by cattle. Despite the decline in U.S. cattle numbers, Elanco's cattle business remains strong, led by Experior.
With continued strong performance, we now expect Experior to reach blockbuster status with sales expected to exceed $100 million globally this year. Recent combination clearance approvals for Experior are expected to allow for broader expansion into Heifers which represents nearly 40% of the U.S. feedlot population, a key growth driver in 2025. Additionally, we continue to see very strong demand for Rumensin as the strength of our integrated portfolio continues to deliver. Cattle vaccines benefited from favorable comparisons to the third quarter last year, but to a lesser extent than in the prior 3 quarters.
In swine, difficult producer economics in the U.S. are impacting the industry as producers are reducing investment in productivity and certain other products. We expect this dynamic to continue in 2025. Finally, our portfolio benefited from poultry rotations again in the third quarter. Given the variability in purchasing patterns driven by rotations in this business and our positive performance in late 2023, we expect a headwind to growth in the fourth quarter and into the first half of 2025.
Finally, in international farm animal, the 3% organic constant currency revenue decline was driven by 2 discrete factors: the intentional due different commercial model changes we introduced with the initial '24 guidance as well as the impact from the Kexxtone product recall. Overall, we're encouraged by the performance of the business, with growth led by price and the new products, along with a stabilizing base, allowing us to report our fifth consecutive quarter of underlying revenue growth.
Moving to Slide 6. We continue to advance our innovation portfolio and productivity strategy. To hit the highlights, our net leverage ratio was 4.3x at the end of the third quarter, and price growth is 3% on a year-to-date basis. Now on to innovation, which delivered $112 million of sales in the third quarter and $321 million on a year-to-date basis, as shown on Slide 7. Today, we are tightening our expectations for 2024 innovation sales, bringing up the bottom end of the range by $20 million with $420 million to $450 million now expected for the full year of 2024 and $600 million to $700 million next year.
Third quarter growth was driven by continued momentum from Experior, AdTab and Credelio Plus as well as the U.S. and Brazil launch of Zenrelia late in September. Now let's talk about our 3 key innovation products in more detail on Slide 8. We are thrilled to be the second animal health company to enter the $1.7 billion global dermatology market. Since our U.S. approval in late September, the launch is progressing very well. We are pleased to be hitting all our key internal metrics as we've now been executing the strategy we laid out in our conference call on September 20.
Focusing first on vet education, driving positive experience and accelerating the incentive to buy. Our vet education strategy starts with our field sales team, who bring the product benefits and considerations to life in the clinic, utilizing the U.S. product label and the head-to-head study data results. Additionally, over the past several weeks, we have hosted numerous medical education meetings, advisory boards, weekly webinars and regional dinner meetings where Board-certified dermatologists and well-respected veterinary thought leaders have shared their positive experiences.
These discussions include clinical data outcomes and successful case studies from trial participants. Our survey data shows the intent to buy increases significantly after these educational touch points with KOLs and veterinarian peers. Additionally, in mid-October, a Zenrelia vaccine booster study was presented at the Symposium. The promising results concluded that when dogs were administered, ilunocitinib for 56 days at 1 time or 3x the label dose, the number of dogs with protected titers on days 43 and 56 following administration of canine core booster vaccinations including rabies were similar among all treated and control groups.
No serious adverse events were observed. The data is accessible to interested veterinarians and our Elanco regional consulting veterinarians continue to provide support on questions and individual treatment decisions. The second pillar of our strategy is driving a positive experience. We continue to execute a targeted sample strategy. We had a number of early adopters enrolled in our early experience program, allowing us to gain valuable success data around real-world outcomes of Zenrelia and a variety of different case types.
We see a clear opportunity for Zenrelia to be used in all types of allergic itch cases and believe it has the profile to be a first-line treatment. It is very clear Zenrelia works, and it works really well. Both veterinarians and pet owners that have experienced the product have been very pleased with the speed and the level of improvements of their dogs. With only a few weeks passed since the booster vaccine data was presented, key launch metrics, including clinic penetration, reorder rates and average order size are all progressing in line with our expectations.
We are tracking reorder rates for many clinics, demonstrating the product is being used and replenished. The key leading indicator we are tracking is clinic penetration. We are seeing the product placed in hundreds of new clinics each week. We plan to update the market quarterly on this metric beginning early next year. Our global launch is in full motion, and we continue to invest in and execute a no-regrets approach. Overall, we are pleased with the launch of Zenrelia and encouraged by the adoption we are seeing in both the U.S. and Brazil.
We look forward to the fastest ever globalization of a launch for Elanco with Canada and Japan now approved, both with less restrictive labels than the U.S. and launching over the coming months. We are thrilled to be just the second company to offer an innovative new treatment in canine dermatology space and strongly believe in the efficacy benefits Zenrelia has to offer.
We see relevance for all cases of atopic dermatitis and for this product and believe Zenrelia has the potential to grow the market while unleashing a significant growth lever for Elanco. We are focused on building a sustainable leadership position in dermatology and Zenrelia is just the beginning. Additionally, as expected, less than a month after the approval of Zenrelia, we received U.S. FDA approval for Credelio Quattro, the newest addition to the Credelio franchise, which includes Credelio Dog, Credelio Cat and Credelio Plus.
Credelio Quattro is the first and only canine oral parasiticide to protect against fleas, tick, heart worms, roundworms, hookworms, and 3 different species of tapeworm in a single monthly dose. We are thrilled to bring this differentiated product to the U.S. market. insecticides or flea, tick and intestinal parasite combination products are the fastest-growing category in the $3.8 billion U.S. parasiticides market with these broad spectrum products now making up nearly 25% of the market.
And Quattro is positioned also to strengthen Elanco's value proposition in the prescription parasiticide market. We are progressing nicely through the final stages of manufacturing scale-up to optimize the launch, which remains on track for the first quarter of 2025, prior to the major parasiticide season. We expect Credelio Quattro to be a major consumer-focused launch, contributing to the growth of the overall parasiticide market driving share growth for Elanco.
Shifting to farm animal innovation, we are encouraged by the progress of Bovaer, and we achieved several key milestones. Notably, permission was granted for the sale and use of Bovaer in California, a key dairy production state and the first cows were also fed Bovaer. We continue to expand the reach of our uplook database with approximately 800,000 dairy cows enrolled and activated expected to trend towards 1 million cows by the end of the year. Overall farmer demand is very robust.
And finally, multiple large CPG companies have signed contracts in to purchase in-set carbon credits. We've updated our pipeline chart on Slide 9. And as you can see, we are now in or entering the commercial execution phase for the majority of these products. We are excited to share more information on the progress of these launches in the coming quarters, but early indicators are positive. We are focused on investing appropriately to ramp adoption, take share, expand markets and build strong brands. With that, I'll hand it over to Todd to discuss our third quarter results and outlook in more detail.
Thank you, Jeff, and good morning, everyone. Today, I'll focus my comments on our third quarter adjusted measures, so please refer to today's earnings press release for a detailed description of the year-over-year changes in our reported results. Starting on Slide 11, we delivered $1.03 billion in revenue, representing a 4% reported decline. Excluding the impact of foreign exchange rates and the divestiture of our Aqua business, organic constant currency growth was 1%. Price contributed 2%, while volume declined 1% when excluding the Aqua divestiture impact. Slide 12 provides revenue by the 4 quadrants of our business in the quarter. Total Pet Health revenue declined 2% in the third quarter with price growth of 2%.
Our U.S. business declined 4% with supply volatility for vaccines and competitive pressure in the veterinarian clinic contributing an estimated 12 percentage points of decline in the quarter. We are pleased by the volume growth from our OTC retail parasiticide business, which saw the normalization of retailer purchasing patterns, more in line with demand in the third quarter and by the contribution of increased sales of new products, which together contributed 8 percentage points of growth.
Importantly, next year as supply headwinds are expected to subside and innovation contribution continues to ramp we expect a return to growth in U.S. pet health. Outside the U.S., constant currency pet health revenue growth of 2% was driven by Europe, led by AdTab and Seresto as our retail investment strategy and execution continues to drive demand growth throughout the region. This was partially offset by competitive pressure in Australia.
Moving to farm animal. Globally, third quarter revenue growth was 3%, excluding the unfavorable impact of foreign exchange rates and the impact of the Aqua divestiture. In the U.S., revenue growth was 11%, primarily driven by strength in cattle across both new and legacy products. Experior and Momentum continued to be key contributors to growth along with poultry in the third quarter, partially offset by the profitability challenges for swine customers. We are very pleased with the 18% growth in U.S. farm animal over the trailing 12 months as our innovation has driven greater benefit across the portfolio.
In 2025, we expect growth will decelerate from this elevated level, but remain above average industry growth rates, driven by Experior and -- outside the U.S., farm animal revenue declined 3%, excluding the impact of the Aqua divestiture and the unfavorable impact of foreign exchange rates. Aligned with our expectations, the decline was driven by our strategic decision to change our go-to-market model in certain geographies, including Argentina and exit low-margin distribution agreements.
We estimate this due different approach and the Kexxtone recall in Europe drove 3 percentage points of decline year-over-year. Excluding these discrete impacts, increased demand for our poultry products in Europe was offset by declines in Australia, driven by drier weather and generic pressure. Continuing down the income statement on Slide 13. Gross margin declined 230 basis points to 52.2% of revenue. The decline was driven by the impact of the Aqua divestiture on product mix, inflation and unfavorable manufacturing performance.
The impact from slowing down the plants over the last 4 quarters was largely neutral in the quarter. Operating expense increased by 3% in the third quarter, driven by higher employee-related expenses and increased expenses supporting the U.S. pet health business, partially offset by savings related to our first quarter restructuring announcement. Strategic investment in the key launches is critical to the long-term success and profitability of the brands despite being a temporary near-term EBITDA headwind.
Interest expense was $46 million, a decrease of $26 million year-over-year as the proceeds from the Aqua divestiture enabled significant debt paydown at the beginning of the third quarter. Adjusted EBITDA was $163 million in the quarter, a decrease of $51 million on a reported basis or $27 million, excluding the impact of the Aqua divestiture. Adjusted EPS was $0.13, a decrease of $0.05 in the quarter. On Slide 14, we include a bridge for the third quarter results compared to the prior year.
Additionally, in the quarter, we recorded a gain on the sale of our Aqua business, which impacted reported EPS by $0.94. Now let me offer a few words on our cash, working capital and debt on Slide 15. Cash provided by operations was $162 million in the quarter. On a year-to-date basis, operating cash improved by $250 million, driven by improved inventory performance, strong collections and lower project expenses.
We ended the quarter with net debt of $3.897 billion, inclusive of the $1.3 billion of debt pay down from the proceeds of our Aqua sale. The net debt to adjusted EBITDA ratio was 4.3x at the end of the quarter, down from 5.7x at the end of the third quarter in 2023. We remain confident in our year-end net leverage in the mid-4x range. We've updated Slides 25 and 26 in the appendix to reflect updates to our key debt information.
Based on our third quarter debt paydown, we now expect to have income statement interest expense of approximately $225 million and cash interest of approximately $295 million in 2024. We expect 2025 income statement interest expense to improve by $5 million to $15 million and cash interest to be lowered by $20 million to $30 million. Additionally, we expect an incremental $150 million of cash taxes next year for deferred tax payments related to the Aqua transaction.
Next, I'll provide an update to the September 13 press release regarding the U.K. contract manufacturing organization that entered court supervised insolvency in September. This CMO is a critical supplier for Elanco, representing approximately $160 million to $180 million in annual farm animal revenue across species and countries. The entity remains in court supersized insolvency, and we are working closely with the parties involved to maintain continued product supply.
For 2024, we continue to expect an adjusted EBITDA headwind of approximately $5 million to $10 million, primarily in the fourth quarter. For 2025, we believe there are a variety of scenarios all with an expected year-over-year adjusted EBITDA headwind between $25 million and $35 million, primarily on gross profit. We expect to reach a resolution in the coming weeks, but have reflected this expected outcome in our 2025 growth outlook.
Finally, let's move to guidance on Slide 17. For the full year, the outlook for our underlying business remains positive. We are narrowing the range for revenue to be between $4.42 billion and $4.45 billion, representing 3% growth when excluding headwinds from foreign exchange rates and the impact of the Aqua divestiture. There is no change to the midpoint of the sales guidance range as increased expectation for innovation sales is offset by lower expectations for U.S. pet health parasiticide revenue. We expect adjusted EBITDA of $900 million to $930 million, reflecting expected gross margin headwinds from product mix and manufacturing performance.
And finally, adjusted EPS is expected to be between $0.89 and $0.95, with improved expectations for interest expense and tax offsetting the items impacting adjusted EBITDA to result in no change to the midpoint compared to August. Our fourth quarter guidance is detailed on Slide 18, with organic constant currency revenue growth expected to be between 1% and 4%. Despite the headwind from Aqua, adjusted EBITDA and adjusted EPS are expected to grow primarily based on the comparison in the fourth quarter of 2023, which included meaningful headwinds related to Argentina as detailed on Slide 19.
Finally, we wanted to provide some additional context on our expectations for 2025 on Slide 20. On the top line, we remain confident in our trajectory towards innovation sales of $600 million to $700 million with expected organic revenue growth to accelerate to mid-single digits compared to our expected 3% growth in 2024, with growth expected in both pet health and farm animal. In Pet Health, growth is expected to be enabled by increased contributions from new products and strength in our pet health OTC business.
We expect continued headwinds on our legacy U.S. pet health and vet clinic business, although lessening as Credelio Quattro and Zenrelia are expected to contribute to returning this business area to growth. On the farm animal side, we continue to expect above-market average growth led by new products in cattle, but anticipate headwinds resulting from poor swine producer economics generics and unfavorable comparisons related to strong poultry rotations in 2024.
Based on our updated guidance for 2024, the jump-off point, excluding the estimated Aqua contribution for the full year should be approximately $875 million of adjusted EBITDA. This reflects our 2024 guidance midpoint of $915 million less approximately $40 million of estimated Aqua EBITDA contribution in the first half of 2024. Looking forward to next year, we expect the underlying business to drive mid-single-digit organic adjusted EBITDA growth, inclusive of meaningful strategic investments in our key blockbuster potential launches. As I shared earlier, the anticipated $25 million to $35 million headwind from the U.K. CMO situation ultimately puts our organic adjusted EBITDA growth expectations in the low single digits range.
From a cash perspective, we expect a few headwinds to our cash available for debt paydown, including deferred tax payments from the 2024 Aqua proceeds and increased capital expenditures to support capacity expansion at our monoclonal manufacturing facility. With all this in consideration, we continue to expect net leverage to be in the high 3s to low 4s range continuing us on our deleveraging path. We will continue to keep our eyes on the foreign exchange markets over the coming months and look forward to providing our detailed 2025 guidance next February. Now I'll hand it back to Jeff for closing comments.
Thanks, Todd. Elanco is delivering on our expectation of an improved portfolio with our fifth consecutive quarter of underlying top line growth in the third quarter and 6 projected in our fourth quarter guidance this year. We expect full year organic constant currency revenue growth of 3%, an acceleration from 1% growth in 2023. We are continuing to outperform where we have leadership like pet retail and farm animal and are launching into big market spaces where we've had previously portfolio gaps and competitive pressure. Gaining regulatory approval for 2 differentiated blockbuster products in the 2 largest spaces in pet health within a month is unprecedented.
The determination, resolve and unwavering commitment of the One Elanco team was on full display not just recently but over many years leading up to this point of delivery. We have officially moved from R&D and regulatory to commercial launch mode, for all 3 big products, Bovaer, Zenrelia and Credelio Quattro with growing tailwinds from Experior, AdTab and Credelio Plus. 2025 presents an invigorating opportunity to strengthen our position in pet health globally and see the market come to life for livestock sustainability. Building on our momentum this year, we expect revenue growth to accelerate next year to mid-single digits.
We expect to grow adjusted EBITDA low single digits in 2025, excluding Aqua as we make intentional investments with expected multiyear benefits aimed at building our brands and maximizing the returns on our innovation investments. This sets us up for continued top line momentum, coupled with anticipated margin expansion in 2026 and beyond, shifting our focus towards the bottom line growing faster than the top line. We think this creates an exciting value proposition and look forward to updating you more formally on our 2025 guidance in February next year. With that, I'll turn it over to Katy to moderate the Q&A.
Thanks, Jeff. [Operator Instructions] Operator, please provide the instructions for the Q&A session, and then we'll take the first caller. .
[Operator Instructions] Your first question comes from the line of Michael Ryskin from Bank of America.
Congrats on the quarter on the Jeff, maybe 1 for you to start. You talked about Zenrelia and obviously, a lot of focus there. You mentioned a couple of times hitting internal metrics. Specifically, I think you outlined clinic penetration is something to really watch -- any early indications of what metrics are exactly? Just give us some specifics in terms of whether -- where you are now, where you hope to be at the start of the year or middle of next year?
Just anything you can point to that we can track progress. Obviously, revenue contribution is expected to be small in the first couple of months. But what should we be looking for? Anything you can quantify to give us a sense of that early progress?
Great. Thank you, Michael. Great question. Yes, let me just step back. The launch is going well. rapid evolving dynamic launch. We are 6 weeks in and the metrics that we are focusing on and that we will communicate more about we're not going to do that today in great detail, but we will as we get towards the next earnings call and we get into 2025.
And those metrics being clinic penetration and reorder rates. So placing the product into clinics and then seeing it being used and replenished, those are the 2 key things. I think a couple of things I would focus are really important at this stage. The first is it's all about efficacy. And let me share that, as I've said, Zenrelia works. It works really well. That's what we saw in the head-to-head studies in the studies as we move forward with the registration.
And what I can say is, yes, ilunocitinib is a different active ingredient and it is delivering great efficacy. And again, as I said, we saw in the head-to-head, we're now seeing it in the field. Of course, it's been given the tough cases where other products did not work, that's been obvious in the early stages. And what I can share, Michael, is it's performed exceptionally well. Some of these have become case studies that are being used with other veterinarians.
I think a couple of things I would say is we do see several hundred new clinics are taking on Zenrelia each week. The ramp is tracking nicely to our expectations. Clinic reorder rates have stepped up every week for the 6 weeks since the launch. And the early signs is our strategy is working. And just a reminder on the strategy, it's around vet education, experience and high share voice and our first kind of round of incentives for our reps are targeted for the end of the year.
And again, we'll be reporting those results into Q1 with you. And I think it's just a couple of other just real quick as it's been asked about where this product is being used. We will say in the early stages. It is being used in all 3 segments of chronic seasonal and acute. It's being used in general practices, and we continue to make good progress with strategic accounts.
We've actually secured agreements a little faster than we originally thought with strategics and it's being placed online. So -- and look, I will point to the segment of there are veterinarians that actually desire more information before full adoption, and this is where we've taken a very tech-to-tech approach where the booster data has been helpful. And what we're seeing there is that there's a longer selling cycle or maybe a lower first order rate initially. So that's where we are, and we'll continue to give you more specifics as we head into 2025.
Okay. Okay. That's helpful. And then maybe for my follow-up, a little bit more of a big picture question. Some touched on it at the end of the prepared remarks in terms of the 2025 framework. As you indicated before, not expecting a ton of operating leverage in '25 because of the investments to drive those new brands. So hence, the mid-single-digit top line growth, but then EBITDA is sort of mid-single, low single, depending on what you're looking at, but I think what we're focused on is sort of that underlying operating leverage, which could be in '26, '27.
I'm not going to ask you to guide to 2026 just now. But just could you sort of walk us through that bridge of what's holding back 2025 operating leverage and how much. So from the gross margin pressures, how much from the incremental investments, how much from sort of these are going to be Quattro -- shows and role going to be low-volume products, so not as much contribution to margins. And that will help us get a sense of sort of, let's say, you do mid-single-digit growth going forward, what kind of operating leverage we could expect in the out years? Hopefully, that makes sense.
Yes, Michael, it's Todd. Thanks for the question. We obviously wanted to give some framework here for 2025 a little earlier than we normally would, we're excited to have these products approved in the marketplace. The sales growth from innovation is what's going to drive the bottom line. As you rightly point out, in 2025, it won't be as fast as the top line growth, the U.K. CMO situation is clearly pulling us down at the gross margin level and then we're going to work really hard to keep our G&A functions flat to declining, so we can take incremental savings from there really invest it behind these potential blockbusters.
The Credelio Quattro and Zenrelia, we're really excited to have in the field and want to get understanding the consumers and death about how efficacious and good these products are. So we'll be growing those sorts of investments in line or faster than the sales growth that comes from that. all with an expectation of building momentum for the next 3, 5, 10 years, where we'll start to get that leverage you spoke of and start driving profitability faster on the bottom line than on the top line in '26, as Jeff mentioned in the prepared remarks.
Your next question comes from the line of John Block from Stifel.
Thanks Todd, yes, thanks for the 2025 preliminary guidance, I certainly think it's helpful. I guess you have 2025 preliminary and then we'll all sort of -- and see what else we can get. So going down that road, I just think the EBITDA, low single-digit growth adjusted for Aqua I'm just trying to, again, a high level thinking about the cadence.
Do we view that as somewhat back-end weighted because it's suppressed because of the investments. And so should we think about the investments more prominent or at least it's all cash out call in the early part of the year as the revenues will follow in Quattro, maybe even IL-31, but -- when we think about the low single digit, again, anything on the cadence and sort of where I went with the question, is that the right way to maybe work it through the model in '25.
And John, I don't even want to give guidance for '25 this early, and now you want me to give quarterlies. Now I appreciate the question. And yes, I think you're thinking about it correctly. We're going to make the investments in Q3 numbers where most of the investments are really driven by the expanded health sales force that we brought at the start of the year. They know their customers. The customers know them well. And so that's really set up here as we launch Zenrelia then close on the heels, we'll becoming Quattro, and those investments will be in front of the sales ramp.
And so yes, we generally think cadence you're thinking about being a little more front-end loaded on investment with sales growth over the course of the year. At the same time, Experior and the Heifer clearances we got here in the last couple of weeks, we'll keep it ramping up and growing. And then AdTab, which is that parasiticide season, first half continues to grow really nicely as well. So we're excited by all the innovation we have, especially on a global footprint not just what Zenrelia and Quattro will do for our U.S. vet business.
Got it. Very helpful. And then I'll just shift gears to go back to Zenrelia and Jeff, is there a percent of practices that are saying -- the label is a nonstarter for me. Hey, look, I just can't get my arms around this all and even with your additional data around dosing, this is a nonstarter. Is it 10% of practices that you reached out to? Was it if you don't want to give that, maybe if you can help us out if it's been in line with expectations. I mean, clearly, we'll have to see where practice penetration falls.
And I'm guessing that takes several visits from a local rep to eventually get there. But I'm just curious in the early days of that noise around the label and the nonstarter and how that compares to company expectations.
Yes, great question, John. I would say if I look at the segments that are occupying our time right now and really provide the great opportunity is the early adopters, and they're ramping and we're servicing them, and that's expanding. So as you get into more and more clinics then you're starting to see the size of orders and the replenishing grow. .
And so we continue to see that segment being quite material and significant and will lead our ramping of clinics, as I said, the several hundred or so per week. And then I think the second one is what you're highlighting is we don't see any stopping. What we're seeing is the vests that we expected that really want to just be able to have that scientific discussion tech to tech, review the booster data has been extremely helpful and alleviated a lot of questions and concerns.
And then what does that lead to? It leads to 2 metrics, John, that we're seeing. One is more call frequency needed when you may have needed 1 or 2 calls, that may go up a little more. So we're increasing whether it's approaches to make it more efficient more dinners. So we can have more touch points more efficiently in a more accelerated way. And then second is the orders tend to be a little smaller. So on that segment, which is, hey, we want to get it in. We want to try it. We want to try them maybe our trouble cases and then that ramps.
So actually we like the trajectory of these metrics in these segments and the approaches. We haven't had to adjust our strategy. We have shifted some resources but again, we're very pleased where we are. And I would back up you to be very excited about the size of the derm market. It continues to grow. I believe in the U.S., it's growing at 15% the last 12 months, and we're making nice progress.
We also have -- our regulatory team has the meeting with the FDA this month and the submission of that additional data to the FDA has already happened prior to that meeting. So great progress.
Your next question comes from the line of Erin Wright from Morgan Stanley.
So on IL-31, can you give us an update on your conversations with the USDA on that product and how we think about the timing of the launch first half, second half and just the opportunity with the long-acting in light of Zenrelia, and it sounds like you're scaling up the manufacturing AdTabs. And just how you think about the competitive landscape, I guess, evolving in derm?
Yes. Thank you, Erin. There's no question. I'll start with the overall derm market. We have numerous assets. As you know, we're starting with Zenrelia. We've got short-acting and long-acting coming, short-acting expecting an approval in '25, as you know. And then this is a key area of focus for and we really are excited about what is in our pipeline in derm. And again, next-generation first and best-in-class overall. Specific to the IL-31, the engagement is going well, not really anything new to report other than it's progressing well. We continue to see it as a blockbuster product differentiated from the incumbent in the market today and it will be a nice complement to Zenrelia and we'll globalize the launch as we are with Zenrelia. But again, things are progressing and all we'll say at this point in time is approval expected in '25.
Okay. And on Credelio and Credelio Quattro, I guess how are you thinking about pricing here? And when you launched, I guess, legacy Credelio, you were at a premium. Do you expect to take a similar approach, just given the differentiation of the product? And on Zenrelia and pricing, so 2 pricing questions here. Just given the dosing for larger dogs, is the pricing still shaking out to about a 20% discount relative to the competitor? Or is that playing out according to plan?
I'll take the first one. I'll give Todd on Zenrelia here. But on Quattro, we're looking at this as, overall, I think, Erin, most importantly is the biggest trend I see right now in animal health is this broad spectrum parasiticide market especially here in the U.S. is growing and now accounts for about 25% of the $3.8 billion market in the U.S., and it's taking share really from legacy products inside the vet clinic. And so we look forward to entering with Quattro. This will be a very heavy consumer component type launch. It's more of an uninvolved category. So to Todd's earlier point, we do expect launching this product ahead of the parasiticide season in Q1 and taking a DTC and a heavy investment approach as it's a little bit more of an uninvolved category as a whole.
When it comes to pricing, we'll take a value-based approach, we believe we've got, as you know, a differentiated asset here, but also, again, back to the no regrets approach, we want to take share. We want to gain experience. We believe notionally, our core portfolio is still smaller so we see this without question, will grow our share in parasiticide in the U.S. and be a key accelerator to returning U.S. pet back to growth as we go into 2025.
With respect to the pricing question on Zenrelia Aaron, it is, on average, about a 20% discount with this introductory pricing that we started with the Zenrelia to really give a great value for consumers as they think about how to treat their itchy dogs. given the way we've structured the pricing for larger dogs, it's a bigger discount to the 20%, which is really valuable given the nature of the dosing they need to get the animal under control. You can see the pricing deltas on the online retailers that both us and our competitor uses. But overall, we're pleased with the pricing strategy that Bobby and his team have launched and are thrilled to be allowing pet owners to have a more reasonable price to offer to really they solve their itchy dog problems. .
Your next question comes from the line of Brandon Vazquez from William Blair.
As we go into 2025, can you talk a little bit about -- I think there was a comment about this earlier with your sales force. Are there going to be any changes in comp. You obviously have a lot of new good products that sales force is going to want to push? Any changes to the comp for to make sure that the entire portfolio is kind of moving forward. Just curious if there's anything notable there to talk about.
It's a great question, Brandon. It's something we've put a lot of attention on the last couple of years. Bobby his team, some of Todd's team brought in some outside expertise. We believe our incentives for sales reps are key to sell and prioritize the portfolio. What I would say is we will have incentives that will be geared definitely with a little bias to the new products and the ability to sell that broader portfolio.
At the same time, they're going to be more enabled, where another investment has come is really just around next-generation commercial where we've got the digital ability to actually know what we need to detail, what wasn't detailed is being followed up with telesales or with electronic engagement, and we've really proven that out with some of the new products like Xorbium and the parvovirus monoclonal antibody. So those are the 2 areas of investment, we, again, as I said, have our reps very incented on Zenrelia now to the end of the year, and we'll be updating that as we bring Quattro to the marketplace.
Okay. Great. And as a follow-up, Seresto and advantage if I collectively do those revenues year-to-date, up about 7% reported, probably up a little higher even on an organic basis. which is encouraging. So I'm just curious if you could talk to this is almost, I think, 40% of your pet health sales at this point. How durable is kind of like a 7% level. Is this -- do you guys feel like this might be a new level here where you can maintain or grow off within to '25?
Thanks for the question, Brandon, on the portfolio. Yes, Seresto's had a nice year. Some of that is influenced by the bounce back in Spain to put that growth rate a little higher than what we'd say the normalized level is. In the U.S., we continue to make nice progress with our physical availability, more points of distribution, more different price points by bringing back the A family originals with classic I wouldn't say we expect 7%.
We're probably close to a low single-digit expectations for the portfolio. As a reminder, we've added AdTab given it uses the A family name and so that's a real positive. The drag on A family is with advocate inside the vet clinic where like the legacy portfolio of parasiticide is getting impacted and while we're so excited to bring Credelio Quattro to the U.S. like we already have Credelio outside the U.S. And then on the family, we're also -- we've relaunched our supplements inside our retailers under the Advantage family name.
Don't expect that to be a massive product category for us, but it continues to build out our relationships as key supplier to the Walmarts, the petcos of tractor Supply stores that are so important for this business to help customers get our products wherever they want to shop.
And I would link it too, there's a common question in our industry is about revisits and this has really been part of our strategy as the omnichannel approach in and outside the vet clinic has actually helped us insulate. We're seeing that now with that trend as well as with the economic pressures as some pet owner segments trade down, as Todd mentioned, we've been able to actually capture that share with the Advantage Classic and others.
So those are 2 trends externally that actually we think Elanco is actually competitively well positioned for.
Your next question comes from the line of Balaji Prasad from Barclays.
Thanks for the questions. So firstly, I can't help feel that the expanded portfolio should give you a significant portfolio advantage that you won't had much of the veneer clinics. So with that, I'm surprised to see competition in U.S. pet health, vet clinics still being called out as headwind as a material headwind for 2 -- so which are the areas where you expect to be at a competitive disadvantage and where you are in the -- secondly, congratulations on reaching the Experior blockbuster status. So what does it mean for long-term direction of growth, how would you quantify the current level of market penetration, market saturation?
We feel good about that portfolio. But there's a reality of the pair of business inside the vet clinic where we expect Credelio Quattro cannibalize some of our own brands, but also continue that competitive pressure. Net-net, we're going to grow in U.S. health in Q4 and next year because of the innovation we're bringing to the marketplace. .
With respect to Experior, we're thrilled with respect to the loss to ramp, as we said, calling after it will exceed $100 million globally in 2024. And now with these effort clearances, we're accessing about 40% of the feedlot animals that we couldn't access before. So that allows this growth to continue, and it will be a big driver of our mid-single-digit growth in '25.
Your next question comes from the line of Chris Schott from JPMorgan.
Just 2 questions for me. Maybe first, just talk about kind of bigger picture pricing outlook as head into next year. It's maybe a healthier environment for pricing the last few years. I was wondering if you expect that to be able to continue into 2025 or normalize a bit.
My second question was just on Quattro and just can you just elaborate a little bit on how you see the product ramping next year as you come to market? I guess my question here is, should we initially expect that a lot of the use here are prior Credelio users, I guess, initially in 2025? Or do you think you can kind of right off of that target, maybe a broader swath of vets to adopt the product. I'm just trying to say, is that more of a '25 event? Or is that something that plays out more over time?
Yes. Thanks, Chris. On pricing, we've seen as an industry, as you know, for a lot of years, 2% as an average, higher in pet, higher in the new innovation areas, lower in farm animal and the generic categories. We saw that rise up a little higher coming out of inflation in the last couple of years. .
I believe that it's probably headed back more to historical levels over time. But no question, innovation coming into a portfolio gives you the ability to leverage price -- and that's what we're doing. The portfolios that have a significant innovation in them, we're able to actually raise the price for the portfolio. So I think it's going to fall somewhere in between for us as we head into 2025.
As you look at Quattro, look, as I mentioned, how do we see this ramping? There's no question I'll reiterate. We believe that we're bringing this product and make a lot of good progress to prepare for the launch to be in the market in Q1 ahead of the season. We will be investing accordingly because we do believe the season matters.
But I also would say that this broad spectrum parasiticide segment has shown less seasonality and much more focused on launching, penetrating in the markets that you're going to target. So we expect it to ramp, but we do expect that will occur over the course of the full year.
Our next question comes from the line of Umer Raffat from Evercore ISI.
This is Mike DiFiore for Umer. Three quick ones for me. First, regarding the Zenrelia vaccination booster study. I noticed in that trial except for canine -- virus, 100% of dogs remained above the prespecified protective thresholds at the 1X and 3x dose levels. Just kind of curious as to what explains the canine distemper component not hitting these levels? And is that a sticking point among that may be on the line. Those have 2 follow-ups.
Yes, Michael, the booster study, again, was run very well, 1, 3x is Zenrelia dose, number of dogs achieving, as I said, appropriate titers above the vaccine, and this has been received very well and very consistent results. And again, no serious adverse events were observed, and this has been extremely helpful in the to that conversation.
Got it. Okay. Next moving on to Quattro. Obviously, tapeworm is surely more endemic to certain geographic regions in the U.S. But in geographic areas that it isn't endemic, can you speak to a level of enthusiasm and receptiveness for this product? And would you expect more seasonality for Quattro in these nonendemic regions?
And lastly and separately, I noticed that your expected innovation sales in 2024 has crept up $10 million at the midpoint from $400 million to $450 million now to $420 million to $450 million. I may have missed this, but what's expected to drive this incremental increase in innovation revenue.
Yes. I'll let Todd take the second one. On the first one, look, the first thing, Mike, that's going to drive is what you're seeing is this trend. You've got $3.8 billion in the U.S. of parasiticides a little over $1 billion now as these broad spectrum and dictate we're coming into that market. We see the natural growth of taking share across that larger market is probably 1 of the best tailwinds that we see overall.
Broadest coverage always is the broad coverage always is a benefit. We also would add not just the tapeworm element, but we put out recent data around tick efficacy, which I think is a real positive. And we've got heartworm control and prevention. So a few layers of differentiation, a big, fast-growing market, and we've got a lot of expertise in 1 of the largest sales forces in the U.S. and a good distribution relationship as well. All of these are components that give us great advantage going into 2025 with Credelio Quattro.
And then Mike, on the innovation increase, it's really the Experior continue to ramp a little faster than we expected last quarter as well as AdTab and Credelio Plus outside the U.S.
Our next question comes from the line of David Westenberg from Piper Sandler. .
It's going to sound like I'm jumping around, but no actual. I'm just trying to get to kind of contribution margins as we're moving into '25 and 2026. So on the farm animal side, nice update on Bovaer, are there any other states or countries in the pipeline that could be active and staying on farm animal Experior and Heifer update, that's great. Can you give us a little bit of flavor in terms of the size of this opportunity?
And is Experior have more of a pet margin or more of a farm animal margin? And maybe it's going to change as we get more volume. And then if we are going to see Quattro placing Credelio how should we think about like Credelio becoming a blockbuster because I would imagine that maybe it's at the $50 million point, it's dilutive to accretive or something like that.
Yes, David, real quick on Bovaer. We have rights for North America and getting Canada and Mexico, but our focus is on dairy, even over beef. The clearance is for dairy here in the U.S. And the size of the market is significant and the efficiency to reach that market and the inset market chain that we've set up. So that with an efficient OpEx reach because it's more of a B2B model in U.S. beef and Canada were Experior is sold. .
And then as we've mentioned, our overall parasiticide business is notionally smaller with Credelio Interceptor Plus. So we see cannibalization being less and we do see Quattro being a catalyst to drive our U.S. parasiticide business back to growth and to take share as well.
And our next question comes from the line of Navann Ty from BNP Paribas.
I have 2 on Zenrelia and one on the CMO. So maybe if you can share early feedback on the vaccine booster study, does it already or has the potential to influence that regarding the withholding period before natural label change. And also, we have heard from that 20% to 30% range of -- nonresponders which is higher than we expected. Is that in line with your expectation and debt feedback? And then on the CMO, how long does it take to transition supply and how much visibility do you have on the board proceeding to estimate the 2025 EBITDA headwind?
Yes. Navann, I would just say, overall, the Booster study has been very effective at being able to give vets comfort of how this actually worked again in more what I would say is real conditions for them in the field. And then that leads to whether it's cases or a protocol for them to use it. And again, there's a lot of market available as we continue to focus on with the label that we have today a lot of opportunity here.
I won't speak specific to the number of nonresponders. That varies, varies by time of year and by segment. But overall, what we like is we've been thrown into those cases and Zenrelia has performed extremely well. Todd, on the CMO?
We're working very closely with the bankruptcy administrator in the U.K. to maintain supply of our products to continue to serve customers here in '24. There's a lot of ongoing discussions regarding the future, but I'm very confident that we've got a very good feel of 2025 EBITDA impact given how well we're working with those administrators and understanding the overall operations of that CMO.
Thanks. With that, we'll hand it back to Jeff, to close this out.
Thank you for the time today, and quarters as we close the year, and we've shifted really truly as a company from regulatory to commercial mode. And that's all built on a stabilizing base. I think when we step back inside this company, we're looking at a portfolio of products that are either ramping, launching or entering launch as we look at AdTab, CPMA, Credelio Plus, Experior and now the big 3 Bovaer, Zenrelia and Credelio Quattro. These are differentiated assets that are entering major markets that will be the driver to accelerate in our growth. .
The Elanco team is firmly focused and on our course. -- engagement and execution are ramping. We have this no-regret disciplined approach when it comes to grade offs, our focus and our resourcing and I'm already seeing that pay off in the company. All of this is really intended to drive sequential accelerated revenue growth in Q4 and into 2025, expand our innovation sales and ultimately increase shareholder value. Thanks for your time, special thank you to the global Elanco team that's achieved a lot this past quarter, but mostly a lot the last few years to get us to this point of opportunity on our 70th year as a company. We look forward to engaging with all of you here in the coming months.
This concludes today's conference call. Thank you for your participation. You may now disconnect.