Mallinckrodt - Earnings Call - Q1 2025

Transcript

Operator (participant)

Good day, and thank you for standing by. Welcome to the Mallinckrodt First Quarter 2025 Results Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during this session, you will need to press star one one on your telephone. You will then hear an automated message advising you your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference may be recorded. I would now like to hand the conference over to your speaker today, Gerard Meuchner. Please go ahead.

Gerard Meuchner (Head of Communications)

Thank you, Operator, and welcome, everyone. With me this morning are Mallinckrodt CEO, Siggi Olafsson, and CFO, Bryan Reasons. Before we begin, let me remind you that we will make forward-looking statements on this call, and it's possible that actual results could be materially different from our stated expectations. Please note these forward-looking statements are made as of today, and we assume no obligation to update them, even in the event of new information or if actual results or future expectations change materially. We encourage you to refer to the cautionary statements contained in our SEC filings for a more in-depth explanation of the inherent limitations of such forward-looking statements. We will also provide select non-GAAP adjusted measures related to our financial performance on this call. A reconciliation of these non-GAAP measures is included in our earnings release, which can be found on our website, mallinckrodt.com.

We use our website as a channel to distribute important and time-critical company information, and you should look to the investor relations page of our website for this information. This call does not constitute an offer to buy or sell, or the solicitation of an offer to buy or sell any securities, or a solicitation of any vote or approval. In connection with the potential combination between Mallinckrodt and Endo, Mallinckrodt has filed with the SEC a registration statement that includes a joint proxy statement of Mallinckrodt and Endo and a prospectus for Mallinckrodt shares. The joint proxy statement, prospectus, and other relevant documents filed by Mallinckrodt and Endo with the SEC will be available free of charge at the respective company's investor relations webpage or at the SEC's website.

You should review such materials filed or to be filed with the SEC carefully because they contain or will contain important information about Endo, Mallinckrodt, the business combination, and related matters, including information about certain of their respective directors, executive officers, and other employees who may be deemed to be participants in the solicitation proxies in connection with the business combination and about their interest in the solicitation. As noted in our earnings release, our first quarter ended on March 28, 2025. Additionally, unless otherwise specified, the net sales percentage changes we discussed will be on a constant currency basis. I'll now turn the call over to Siggi.

Siggi Olafsson (CEO)

Thanks, Gerard, and good morning, everyone. I'm pleased to report that Mallinckrodt has a great start to the year, and we continue to build on our positive momentum from 2024. Our teams delivered another quarter of strong performance that kept us on track to achieve our full-year guidance, a sign of our confidence in the business. In the first quarter, we achieved a top-line growth when adjusting for the share cost divestiture last year, demonstrating the meaningful progress we have made on our key strategic priorities. Acthar sales grew for the fifth consecutive quarter, and the launch of our SelfJect device has been tracking well ahead of our initial expectations as we continue to see a strong physician and patient demand. In light of this, we are increasing our marketing investments behind Acthar, which is reflected in our decision to reaffirm full-year guidance.

In addition, our rollout of the INOmax EVOLVE DS delivery system continued to hospitals nationwide, and the ongoing efforts to expand adoption of Terlivaz remain underway. On the specialty generic side of the business, overall performance was strong, and we continue to see the benefits of the high-quality product and stable supply we offer customers. Our positive momentum also reinforces our excitement for the planned combination with Endo that we announced in March. The merger will create a global-scale diversified pharmaceutical leader, and we see even greater potential ahead for our business through the combination. I'll speak more on that shortly, but I want to highlight upfront how proud I am of our teams for continuing to execute at a high level and deliver for our patients while doing the significant planning work to bring our two companies together. I'll turn now to the detailed update on our business segment.

Starting with specialty brands and Acthar Gel, as I mentioned, we are pleased to deliver our fifth consecutive quarter of year-over-year growth with a 12.3% increase in net sales in the first quarter. This was driven by growth in the overall market and the successful launch of SelfJect, where the team has done really outstanding work. Feedback from the healthcare providers and patients on Selfject has been overwhelmingly positive, and this innovative device now accounts for over 70% of all new Acthar brand prescriptions. A number that is even higher for certain therapeutic areas and reflects the great momentum we have with both new and returning healthcare providers. We expect positive momentum in the SelfJect rollout and patient demand growth to continue. As a result, we are raising our 2025 net sales guidance for Acthar from a low single-digit range to a high single-digit range.

Moving to INOmax, our multi-year rollout of the EVOLVE DS delivery system into U.S. hospitals remains underway. As of the end of March, more than 400 devices were placed in over 50 hospitals nationwide, and we continue to benefit from customer interest in the portability and new features offered by the product, reflecting the importance of the system for the appropriate patients. As a reminder, we expect this rollout to continue throughout the end of next year, and we will be working closely with hospitals and providers to drive further adoption throughout this period and beyond. While INOmax sales continue to be impacted by competition in the U.S. market, we were encouraged to see a stronger performance and growth outside of the U.S., particularly in Japan, where sales grew 12% as compared to the first quarter of 2024.

Next, with Terlivaz, we delivered a 23.3% net sales growth as compared to the first quarter of 2024. As a reminder, Terlivaz is the first and only FDA-approved product indicated to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function. While hospital demand growth has not been as strong as we would like, we continue to believe in the opportunities ahead for this treatment, as well as the meaningful benefit it can deliver to patients and their caregivers. Turning to specialty generics, we continue to build on our track record of consistent growth in the segment, delivering our ninth consecutive quarter of net sales growth. Strong performance in the ADHD finished product business was offset primarily by a global competitive pressure on the API business, particularly our APAP products.

In a period of supply chain uncertainty, Mallinckrodt's generics business benefits from both leading product quality and consistency of supply, and we continue to expect a flat to low single-digit sales growth for the segment in full year 2025. Before I hand it over to Bryan, I'd like to give a brief update on our previously announced combination with Endo. Over the last month, we have spoken extensively with our stakeholders about the combination and are pleased with the positive feedback we have received to date. We remain confident in the bright future ahead of our companies as one combined organization, which will benefit from increased scale to develop new therapies to address unmet patient needs. Our team has already hit the ground running in our work to complete the transaction, which we continue to expect to occur in the second half of 2025.

In April, we filed our Form S-4 registration statement with the SEC to begin the SEC process, a key milestone towards holding the shareholder meetings to consider and vote on the transaction. We have also formed a dedicated transaction planning team to support our integration efforts post-close. I look forward to sharing additional details in the coming months as we continue to work to bring our two companies together. With that, I'll turn the call over to Bryan to discuss our financial performance and expectation for the balance of fiscal 2025 in more detail.

Bryan Reasons (CFO)

Thank you, Siggi. Mallinckrodt's net sales in the first quarter of 2025 were $419.9 million as compared to $467.8 million in the first quarter of 2024, reflecting a 10.2% decrease on a reported and constant currency basis. Excluding the impact of the Sarcos divestiture, total net sales grew by 2.5%. Net loss for the first quarter of 2025 was $27.7 million compared to a net loss of $65.4 million in the prior year period. Adjusted EBITDA in the first quarter of 2025 was $102.3 million as compared to $144.9 million in the prior year period. This was driven by strength in both the specialty generic segment and Acthar Gel, largely offset by the impact of the Sarcos divestiture, incremental commercial investments for Acthar Gel, and the impact of nitric oxide competition in the U.S.

The specialty brand segment reported net sales of $207.3 million as compared to $257.3 million in the prior year period. This 19.4% decrease includes the impact of the Sarcos divestiture. Excluding Sarcos, specialty brand's net sales grew by 4.1%, driven primarily by growth in Acthar Gel and the uptake in SelfJect. Acthar Gel net sales were $115.4 million in the first quarter, an increase of 12.3% compared to the prior year period. As Siggi mentioned, we are raising our full-year sales guidance for Acthar and now expect high single-digit Acthar net sales growth in 2025. INOmax generated net sales of $62.5 million in the first quarter, a decrease of 11% compared to the prior year period. Terlivaz generated net sales of $7.4 million in the first quarter, an increase of 23.3% compared to the prior year period.

The specialty generic segment reported net sales of $212.6 million as compared to $210.5 million in the first quarter of 2024. This growth of 1% was driven by continued strong ADHD product sales, offset by a decline in the API business, particularly APAP products, driven primarily by global competition. With respect to operating matrix in the quarter, adjusted gross profit as a percentage of net sales was 61.3% as compared to 64% for the first quarter of 2024. Adjusted SG&A as a percentage of net sales was 32.9% as compared to 27.3% in the prior year, and adjusted R and D as a percentage of net sales was 4.7% as compared to 5.9% in the prior year. Turning to our balance sheet, we ended the first quarter with a cash balance of $422.2 million.

Total outstanding principal debt was $864.6 million, a reduction of 47.5% compared to the first quarter of 2024, and outstanding net debt was $451.4 million, a reduction of 67.6% compared to the first quarter of 2024. Our net debt leverage ratio was 0.8x at quarter end. For the full year fiscal 2025, we are reiterating our previous guidance ranges and expect total net sales of between $1.7 billion and $1.8 billion, and adjusted EBITDA of between $480 million and $520 million. Our decision to reaffirm our previously stated guidance reflects our strong performance, partially offset by elevated SG&A levels due to incremental commercial investments related to AXA. I'll now hand the call back to Siggi for closing remarks.

Siggi Olafsson (CEO)

Thank you, Bryan. To wrap up, I'm incredibly proud of the way our entire team has delivered on the strategic priorities for the ultimate goal of improving the lives of our patients. As we look ahead to the close of the merger with Endo later this year, I am more confident than ever in the value we can deliver to our shareholders, customers, and patients. We will now open the call for Q and A, Operator.

Operator (participant)

Thank you. As a reminder, to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, please press star one one again. One moment while we compile our Q and A roster. Our first question is going to come from the line of Hamed Khorsand with BWS Financial. Your line is open. Please go ahead.

Hamed Khorsand (Principal)

Good morning. Thanks for taking my questions. First, could you just elaborate on the marketing strategy behind Acthar Gel and what you're hoping to achieve? Is it more from the patient standpoint, or is it from the physician standpoint as far as demand is concerned?

Siggi Olafsson (CEO)

Yeah. Hamed, a very good question. I think overall, the two things that are playing in is that the overall market is growing. There is a competition for corticotropin out there. We can see the overall market is growing for corticotropin today, and we are clearly benefiting from that. We have a strong sales support on it, but we also have a big patient support system to support the patients through the experience of going on Acthar, which is very important. I think that's number one. Number two, we have seen a huge benefit on the launch of SelfJect. SelfJect makes it so much easier to use it. What we call new prescriptions, those are prescriptions for patients that have not been on prescription for a long time or are totally new to Acthar at all. Over 70% of those patients are going on SelfJect.

Then some other indication, and I will call out, even though I did not do it in the script, in ophthalmology, it is closer to 80% of all new prescriptions are on SelfJect. These two things together are benefiting, and we have used, as I mentioned in the script, we are putting more marketing emphasis now behind the product when you see the growth. Obviously, Acthar was a challenging story, declining from 2018 up until the beginning of last year. In the last five quarters, we have shown every quarter a growth of this product. The doctors, the physicians are seeing the benefit of it. I think patients are getting more comfortable, and SelfJect was a piece of that that was missing in the puzzle. We are very pleased, but it is both on the patient's side we are seeing the benefit, but also on the physician's side.

Hamed Khorsand (Principal)

Okay. Is this taking away any resources from the rest of the business at all?

Siggi Olafsson (CEO)

No. It's not.

Hamed Khorsand (Principal)

Given the timing of when you're expecting the merger with Endo to close, do you have any new intentions with the cash, or will the cash balance just continue to increase?

Siggi Olafsson (CEO)

No. So we obviously are limited with the merger agreement with Endo, what to do with the cash. So there is a limitation of what to do with the cash until the merger will close in the second half of this year.

Hamed Khorsand (Principal)

Okay. Great. Thank you.

Siggi Olafsson (CEO)

Thank you.

Operator (participant)

Thank you. One moment for our next question, please. Our next question is going to come from the line of Madison Aron with JPMorgan. Your line is open. Please go ahead.

Madison Aron (Credit Research Analyst of Corporate and Investment Bank Markets)

Hi. Thanks for taking my question. Just starting with, can you quantify the marketing support that you're putting behind the drug? You noted that the market is growing for the drug. Can you just walk us through which indications are you seeing that growth, and then maybe define it a little further? Is it more just new patients that they're staying, that adherence has improved? Just lastly on AXA, you talked about the patient support system that you have for SelfJect. Can you quantify or just walk us through how that support system differs from the vial?

Siggi Olafsson (CEO)

Yeah. If I start on the marketing, we haven't broken out the marketing cost per product. What we have said is for Acthar is our largest marketing support in the brand business. We have a sales force, we have marketing, but we also have the patient support system in place. Clearly, a great support for this product. In terms of the indications, which are the growing indications, we are roughly in six to seven, even though I think Acthar is approved for 19 indications in the FDA label, but there are really four indications that are growing the most. It's rheumatology, pulmonology, nephrology, and I mentioned ophthalmology, which is growing fast. Especially, we have seen that with the benefit on rheumatology and ophthalmology. Those are two indications where the SelfJect device has changed the delivery system and experience for the patients of this drug.

This drug has been approved for many, many years. Has a lot of experience. Many patients have been using it through the years, but continues to be a very important drug for patients out there going forward. The third part of the questions, if you could repeat that again.

Madison Aron (Credit Research Analyst of Corporate and Investment Bank Markets)

The patient support that you have for SelfJect, how does that differ from the vial? Assuming that that's you're trying to drive more patients towards that.

Siggi Olafsson (CEO)

Yeah. We do not differentiate. We support all the patients, whether they are on vial or on SelfJect, but it is mainly around the nursing support when patients start. When a patient starts on a vial, there is a little bit more involvement in teaching them how to draw the drug from the vial and inject them to themselves. Where on SelfJect, that is so much significantly easier. We still have the nurse support around that, but that is probably the single most differentiated issue between the vial and the SelfJect. It is simpler to treat with SelfJect than it is with a vial going forward.

Madison Aron (Credit Research Analyst of Corporate and Investment Bank Markets)

Okay. Great. There is a lot of commentary out there about tariffs and Ireland and, I guess, attacking the tax system that is coming out of Ireland. Would love to just get your thoughts on what you're seeing. I know it's early. We do not have a lot of details, but I'd love to hear your thoughts on what you're trying to do to circumvent any of these challenges.

Bryan Reasons (CFO)

Yeah. It's Bryan. I'll jump in there and Siggi add on. As far as the tariffs, when we kind of looked at it, we feel like we're in pretty good shape and don't have a ton of exposure. We have some inputs into our APAP business coming from ex-U.S. We manufacture the bulk API for APAP, but not a lot of exposure. I think your question hinted at kind of the IP structure. Our IP is largely held offshore, but we're an Irish company. We have significant substance in Ireland, including a plant where we manufacture the API for our largest product. And this is my view. For them to eliminate that type, it's probably that type of structure, it would take probably more of an act of Congress, but we don't necessarily see a lot of tariff exposure for us right now.

Obviously, we aren't sure exactly where the tariffs are going to find their way in either. There is a lot of uncertainty there.

Siggi Olafsson (CEO)

Yeah. The difference, I think, between us and many other companies here in the U.S. is we have most of our manufacturing in the U.S. The generic finished dose manufacturing is in the U.S. More than 50% of the API we manufacture ourselves for our generics business, which is in St. Louis and North Carolina and Greenville. That changes the pictures on the tariffs. Yes, some of the starting material for our API, we might have to bear tariffs on that, but overall, we feel the company is in good shape if the tariffs come through.

Madison Aron (Credit Research Analyst of Corporate and Investment Bank Markets)

If I could just squeeze one in. Just given the fact that you have a lot going on in the U.S., can you just walk us through or quantify the tariff tailwind as it relates to the APAP and API business?

Siggi Olafsson (CEO)

Yeah. It's difficult to do the tailwind, but I think how we position things is like with all our generics, are manufactured up in Hobart, New York, where with most of our competitors, although not on controlled substances, in the generic industry, a majority of the volume is manufactured outside of the U.S. I think overall, we are well-positioned from that point of view more than anything else. To go further than that is probably not wise because there's still, as you started your question, there's so many uncertainty around what the administration will do going forward. We feel with the infrastructure that we have, we are well-positioned whatever comes down the road.

Madison Aron (Credit Research Analyst of Corporate and Investment Bank Markets)

Great. Thank you.

Operator (participant)

Thank you. I would now like to hand the conference back over to Gerard Meuchner for closing remarks.

Gerard Meuchner (Head of Communications)

Yeah. Thanks, Operator. Thanks again for joining us all today. We look forward to engage with you in the coming days or week ahead. If you have any questions, the best way to get a hold of us is via email, and we will work with you to get back to you and set up investor meetings. Thanks a lot for all of you to join us today. Thank you.

Operator (participant)

This concludes today's conference. Thank you for participating. You may now disconnect. Everyone, have a great day.