Q2 2025 Mallinckrodt PLC Earnings Call

Ladies and gentlemen, thank you for standing by and welcome to Mel & crowd's. Second quarter, 2025 results conference call.

At this time, all lines are in a lesson. Only mode following the presentation, we will conduct a question and answer session.

If anyone has any difficulties hearing the conference? Please press star zero for operator assistance at any time.

Please note this event is being recorded.

I will now turn the call over to regard Muter to cover forward-looking statements. Please go ahead.

Thank you and welcome everyone.

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 actual results or future expectations changing materially, except as required by law.

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 fully looking statements.

We will also provide select non-GAAP adjusted measures related to our financial performance on this call.

The reconciliation of these non-fat is included in our earnings release which can be found on our website, mnk do.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 mnk dnow.com, all this information.

As noted in our earnings release.

the second quarter for legacy mankind, ended on June 27th, 2025

And the second quarter for legacy Endo ended on June 3025.

Additionally, unless otherwise specified, the Legacy Mount crop results, the net sales percentage changes. We discussed will be on a constant currency basis.

I'll now turn the call over to Sydney.

Thanks, Garrett, and good morning, everyone.

Just last week, we completed the merger of malen, cross and endo.

And we are very excited to be speaking with you for the first time as a combined company.

Today we will cover the financial results of each Legacy business for the second quarter of 2025, which ended a few weeks before, completion of the merger.

I'm joined by the Legacy CFOs of each business. Brian reasons for malen cloth, I'm Mark Bradley forendo.

They will walk you through the numbers and performance highlights from both Standalone companies and then I'll share our outlook for the combined company.

Our merger.

And announcement this morning of our new president and CFO Cristiana stamolis. Uh,

as we announced this morning,

As I mentioned.

We were very pleased to announce the successful completion of a combination of malroth, andando on July 31st.

When we first announced the merger in March, we saw an extraordinary opportunity to combine 2. Highly complimentary pharmaceutical organizations, and our excitement about what mallow and Endo can accomplish together as only grown since then,

Over the past few months. We have had a team dedicated to developing a comprehensive integration plan and preparing for our future as 1 organization.

Through these efforts we have seen how well our teams work together and how closely our cultures aligned and we are starting this new chapter ready to hit the ground running.

I'd like to thank the employees and leaders from both companies for their extraordinary efforts.

We are now focused on executing on our vision for the future of our combined company. And in that regard, I'm excited to announce that we have recruited Cristiana stamolis, um, as our new president and CFO.

Building a new organization requires. Not only bringing together the existing Talent of both companies, but also bringing in a new Talent with experiences and ideas different from our own,

In that regard, we are really excited to have Cristiano on board.

She is an exceptional Talent with deep experience in biotech finance and strategy. And we are looking forward to the contributions. She will be she will make to 14 our new future.

The new mile across combines 2 organizations with Rich, legacies of innovation committed to accelerating the value creation, we can deliver to our stakeholders.

our specialty Brands portfolio spans, a wide range of therapeutic areas of significant unmet need

On this durable on market products, we are well, positioned for growth.

We also have a strong balance sheet and meaningful Financial flexibility. To invest in Innovation and business development.

Our combined generics and sterile injectables business, which operates under the power Health name, features a broad product portfolio.

Our leading Controlled Substances franchise and testing class capabilities at Cross, the value chain.

With financing secured for the merger and I issued acknowledge the effort of our financing Bankers led by avore. We are all well positioned to move forward with our plant, spin-offs in the fourth quarter of 2025 subject to our board's approval, and all the conditions,

We are moving forward with urgency and energy to unlock unlock unlock our full potential, as a larger and more Diversified company. And while we are in early days of executing, our integration plans, we remain on track to achieve our in targets of generating, at least 150 million dollars of annual pre-tax. Run rate operating cities by year 3 and approximately 75 million dollars of pre-tax run rate cities in the first 12 months post merger.

Before turning the over the call, I want to emphasize that a strong financial results. We are sharing today only reinforced my confidence in this combination.

And what we can achieve as 1 organization.

On that note, I'll flip the call over to Mark, who will discuss the Legacy and those financial results for the second quarter.

Thank you figgy on behalf of the entire Endo team. I Echo your remarks about our combination and how excited we are to move forward with 1 company.

Turning the end into a second quarter, 2025 results. We are pleased to share that the company performed in line with endo's expectations for the quarter, which reflected a meaningful sequential increase from the first quarter of 2025.

Second quarter 2025 total revenues were 448 million flat compared to 446 million in the second quarter of 2024.

Which was devastated in the second quarter; total revenues increased by approximately 2% in the second quarter of 2025 compared to the second quarter of 2024.

In the second quarter of 2025, adjusted Evita was $150 million, compared to $176 million in the second quarter of 2024.

This change was primarily driven by lower adjusted growth margin due to changes in product mix and continued investments in the sterile injectables, manufacturing Network.

Second quarter, 2025 adjusted. Net income was 64 million compared to 105 million in the second quarter of 2024.

This change was primarily due to the decrease in adjusted Eva, previously mentioned a coupled with an increase in interest expense.

Returning to segment level performance, the Branded Performance Physical segment, reported revenues of 228 million in the second quarter of 2025 compared to 225 million in the second quarter of 2024.

This change was led by Zaeplex and Sopan, which grew approximately 9% and 13%, respectively, in the second quarter of 2025 compared to the second quarter of 2024.

Zflex achieved another strong quarter, driven by an increase in price and volumes associated with steady growth in underlying demand due to continued patient and healthcare provider education.

Looking forward, we continue to see growth potential and diagnosis and treatment rates.

The sterile injectable segment reported revenues of 87 million in the second quarter of 2025.

Compared to 91 million in the second quarter of 2024.

This change was primarily driven by competitive pressures on adrenaline vials and Vasa strict. It was only partially offset by increased revenues from the adrenaline, ready to use bags and increased volumes across several other sterile injectable products.

On a sequential basis, sterile injectables revenues, increased 23% compared to the first quarter of 2025.

in the second quarter of 2025, we expanded, the adrenaline, rtu bagged product line, with the addition of an 8 milligram concentration to the existing 4 milligram concentration, that was launched in the fourth quarter of 2024,

we also continue to advance the sterile injectables Pipeline and now have 4 FDA submissions through the end of the second quarter of 2025

We continue to remain on track to complete 7 FD submissions and 3 product launches in 2025.

The generic pharmaceutical segment, reported revenues of 119 million in the second quarter of 2025.

Compared to 110 million in the second quarter of 2024.

Revenues from the lidocaine patch grew 31% compared to the second quarter of 20124 and 38% compared to the fourth first quarter of 2025.

Primarily driven by higher volumes, as we continue to respond to market supply Dynamics.

The competitive landscape continues to remain relatively stable, and our contract manufacturing partner continues to increase capacity to address growing market share.

Finally, the international pharmaceutical segment reported revenues of 13 million dollars in the second quarter of 2025 compared to 21 million dollars in the second quarter of 2024.

This decline was the result of the previously announced deve of the international Pharmaceuticals business. It was completed on June 17th,

I will now turn the call over to Brian. Who will discuss mro's second quarter results.

Thanks, Mark Legacy, mcraft, maintain our positive momentum again, delivering strong performance in the second quarter.

Don't cross net sales in the second quarter of 2025 or 485 million as compared to 514 million in the second quarter of 2024.

Reflecting a 6%. Decrease on a reported and constant currency basis. Excluding the impact of the therapist ivestor total net sales grew by 9%.

Net income for the second quarter of 2025 was 2 million dollars and improvement from net, a net loss of 43 million in the second quarter of 2024.

Adjusted even on the second quarter of 2025 was 137 million as compared to 174 million in the second quarter of 2024. This was driven by strength and AAR gel largely offset by the impact of the therapist. By best teacher incremental commercial investment for AAR gel and the impact of nitric oxide competition in the United States.

Email, across 2 business segments, starting with specialty brands.

The Specialty Brands segment reported net sales of $264 million, compared to $275 million in the second quarter of 2024. This 4% decrease includes the impact of the therapist diver.

Excluding therapists specially Brands, net sales, grew by 28%.

The primary driver of this growth was AAR gel which generated net sales of 175 million in the second quarter, an increase of 49% compared to the prior year period.

This significant growth, which represents the highest growth for a brand and more than a decade was driven by Rising category awareness.

Prescriber base expansion and improved patient affordability.

In addition we're nearly a year into the highly successful launch of our self-check device which has been a strong growth driver for the brand enthusiasm for selfjector.

Self-check now accounting for over 80% of all new Axar referrals in the second quarter.

We also saw growth across all therapeutic areas, this quarter, a great indicator of momentum for AAR gel overall.

Turning to inomax. Net sales for 62 million in the second quarter, a decrease of 7% compared to the prior year period.

Those sales in the US continue to be impacted by competitive. Pressures, we are pleased with the growth. We saw in Japan for sales, increased 27% compared to the second quarter of 2024.

Our multi-year rollout of evolved DS, delivery system into US hospitals, continues to progress. Well, as as a quarter end, we had more than 700 devices placed in over 80 hospitals Nationwide.

By the end of 2025, we expect that evolved devices will be used to deliver the majority of nitric oxide of Dynamax therapy in the US.

To live as generate net sales of 8 million dollars. In the second quarter, an increase of 51% compared to the prior year period.

This reflects 23% Hospital demand, volume growth versus the second quarter of 2024 in line with our expectations.

To continue to believe in the opportunities ahead for this treatment as an important option for patients with HRS and their carriers.

Now moving to Specialty generics.

specialy generic segment reported net sales of 221 million dollars as compared to 240 million in the second quarter of 2024, a decrease of 8%

This year-over-year decline, reflects a difficult comparison with the prior period. When high demands for our finished dose products, driven by market constraints and shortages translated to Peak sales volume.

Generic performance was impacted by competitive pressures on finished this opioids and APAC products. Somewhat offset by strong performance and finish dose, ADHD, and addiction treatment product spam

An API, we're encouraged by signs of a turnaround in the APAP Market. A positive indicator of moving forward.

I'll now hand the call back to Siggy for the combined companies' 2025 financial guidance. It's in closing remarks.

Thanks Brian for 2025. We expect total company, net sales to be between 3.757 billion dollars to 3.62 billion dollars and adjusted ibida between 1.1 billion dollars and 1.13 billion dollars.

Of 2025, we expect power Health. Net sales to be between 1.72 billion and 1.75 billion dollars and adjusted EPA between 450 million and 470 million.

As a reminder, the guidance raises for a, just a deep that do not include transaction related compensation expenses related to the merger.

With Syinix's continued momentum and strong performance, we are reaffirming guidance for CYIA Flex revenues to grow in the high single digits in 2025.

As we think about the rest of the year, there's a lot to look forward to our teams are already beginning to implement our integration plans and bring the benefit of this merger to life.

We have also been encouraged by our conversation with our external stakeholders from investors to our partners in the Healthcare Community about their excitement for the merger.

We will be announcing our new corporate name in the coming weeks, I'm following the plan, spin-off of power Health, the Branded Therapeutics company is expected to be listed on the New York Stock Exchange subject to approval of our board of directors.

Before we wrap up, I wanted to express my gratitude to the malikot and Endo teams for the commitment and dedication to helping both companies to get to where we are today in terms of both today's results and the completion of the murder.

They have been instrumental to our collective success, and I deeply thank everyone for their involvement and efforts today.

The future of our combined company is bright and I'm confident in the value. We can deliver to our shareholders employees customers and patient.

And with that, I will now open it up for Q&A.

Thank you, ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please? Press the star followed by the 1 on your touchdown, tone. Did you wish to cancel your request, please? Press the star, followed by the 2. If you are using a speaker-phone, please lift the handset. Before pressing any Keys once again, that is star 1. Should you wish to ask a question?

It appears we do not have any questions, so we thank you all for joining us today. We look forward to engaging with you in the days and weeks ahead. If you have any questions, the best way to contact us will be by email and we will work to get back to you as soon as possible. Thank you again for joining us.

Thank you. Ladies and gentlemen, the conference has now ended. Thank you all for joining. You may all disconnect your line.