Q3 2025 Mallinckrodt PLC Earnings Call

Good day, and thank you for standing by. Welcome to the Kenova Q3 2025 earnings announcements 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 the session. You will need to press star 1, 1 on your telephone. You will then hear an automated message. Advising you, your hand is raised to a draw your question. Please, press star. 1 1 again, please be advised. That today's conference is being recorded.

I would now like to hand the conference over to your speaker today, Gerard Muter. Please go ahead, sir.

Thank you, operator. 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 state at expectations.

Please note, these forward-looking statements on made as of today. November 10th 2025.

And we assume no obligation to update them, even in the event of new information, or if actual results or future expectations change materially except as required by law.

We encourage you to refer to the course, onary statements contained in our SEC filings for a more in-depth explanation of the inherent limitations of such forward-looking statements.

Additionally, we note that this call does not constitute an offer to sell.

For the solicitation of an offer to buy any securities, any such offering would be made pursuant to the registration statement to be filed with the SEC.

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. And in this presentation, which can be found on our website goa.com.

We use our website as the channel to distribute important and time-critical company information, and you should look to the Investor Relations page of the website for the information.

As noted in our earnings release.

The third quarter for Mountain crot ended on September 26th 2025.

Mountain Cross third quarter. Earnings report includes combined business results since the completion of our merger with Endo on July 31, 2025.

Joining me on today's call are Mark Casey, our President and Chief Executive Officer, and Christiana Stamus, our President and Chief Financial Officer.

Figgy and Cristiano will provide an overview of our new company, ginova therapeutic.

And review our performance for the third quarter in detail.

I'll now turn the call over to Sigma.

Thanks, Carol, and good morning, everyone.

This year has been nothing short of transformative for us.

We brought together 2 farmigo. Then we combined our generics and the sterile injectable businesses under the name, par health.

And announced today that we completed the spin-off of that business as a separate private company.

This is an exciting day for our teams and we are proud to introduce you to kinova Therapeutics.

A new company with a new identity, a new future.

Kinova strives to develop therapeutics that help patients with severe and unaddressed conditions live happier and healthier lives.

The Keen focus on helping patients, receive the care they deserve.

And The Innovation required to develop our Therapeutics.

Our new tagline.

Keen to solve Keen to serve reflect our commitment to help solve the challenges our patients face and to serve them with integrity.

Our Diversified portfolios serves areas of significant unmet medical need the focus on Rheumatology Opthalmology, Nephrology pulmonology neurology neurology Orthopedics and neonatal respiratory Critical Care.

We have a strong platform in place with 2 key Brands after Dell and Sops. A US focused footprint. Armstrong commercial capabilities

Following the birth of endo.

We have a greater Financial flexibility to build the robust pipeline by expanding the approved indications of existing assets.

I'm pursuing Business Development opportunities.

The merger also created a meaningful vicinity opportunities.

Kinova is on track on realize and benefit from approximately 75 million of pre-tax run rate cities in the first 12 months, post merger. And at least 150 million dollars of annual pre-tax run rate cities by year 3 post merger.

In the third quarter, we were pleased to welcome new leadership to add to the existing strengths of our executive team at such an important moment for the business.

That includes our president and Chief Financial Officer Cristiana stanulis.

Who has an exceptional record of achievement in strategy. Finance, corporate development and execution.

She is with us on today's call and will review our financials shortly.

Executive Vice President and chief scientific officer to Dr. Marik, hanso has another impressive at the was another impressive, addition to the team.

Marik has a successful track record of launching name brand product at some of the world's largest and most accomplished pharmaceutical companies. And his leadership will be key to building a more robust pipeline as well as a world-class R&D organization at kinoa.

Looking ahead. We currently intend to pursue a listing of kenova's ordinary shares on the New York Stock Exchange in 2026.

Subject to approval by kinova sport of directors and other considerations and conditions.

We expect to conduct a public offering of kenova's ordinary. Fears to facilitate the listing at that time.

In short.

We have a strong foundation in place.

And we are eager to keep building and delivering meaningful benefits for our patients and value for our shareholders and partners.

Our results for the third quarter, reflect that kinova is off to a great start.

While we operate it as a combined business in the third quarter, we will focus our comments today on results related to the brand business.

Where we delivered the 10% Topline growth on a performer basis versus the prior year quarter.

Let's take a closer look at some key products and drivers from the portfolio.

Starting with Actor, gel net sales in the third quarter increased 44% compared to the prior year quarter, marking another quarter of significant growth.

We are now in the second year, of rolling out our self-care device. And with strong ethic continues to play a pivotal role in after gel's growth.

On the back of growing demands and broadening prescriber base and self-defense consistency. Exceeding expectation. We now expect after deal, net sales growth of 30 to 35% for the full year.

As we experience a certain unexpected, shipment delays.

We are also making important progress in our cylex pipeline for new indications.

I'm pleased to share that we have initiated a clinical program evaluating science for hammer toe and we have already recruited over 30 patients.

We are also on track to complete patient enrollment in our Phase 3 clinical program evaluating science for FL for plantar fibrosis by the end of the year.

And we now expect Topline data to be available in the second quarter of 2026.

Lastly, on IMAX, we are pleased to see continued growth outside the U.S., with strong performance in Japan.

We also continue to advance our multi-year rollout of the the evolved vs. Uh, delivery system into US Hospital.

As of the end of third quarter, we have more than 900 devices placed in over 100 Hospital Nationwide.

Our excellent execution this quarter should position us to have a strong finish to the year.

Before Cristiana discusses the financial results in more detail. I would like to take a moment to acknowledge our teams.

As I mentioned this year has been transformative and our employees.

Have navigated many significant challenges primarily.

The work of bringing together 2 companies and executing a spin-off.

Their unwavering focus on advancing, our strategic priorities and dedication to serving patients, have put us in a position for continued success.

Our people are why I have every confidence in a bright and future, bright future for kinoa.

Now, I'll turn a call over to Christian.

Thank you for the introduction, CV. I'm excited to be speaking here for the first time as President and CFO of Kinova.

This started my new role in September, I have been deeply impressed by the team here, and the commitment to making the most of the unique opportunity. We have to reinvent our company.

It's a promising time for all of us and an honor for me to be part of the innovative.

Before discussing the financial results for the quarter, it is worth noting that as a result of the merger with Indors, the company operated in three reportable segments during the third quarter of 2025.

Specialty Brands generic and sterile injectables.

Going forward. Innova comprises only the specialty brand segment while perhaps comprises a generic and sterile injectable segment.

I would like to also point out that the company's third quarter earnings report reflects only 2 months of combined business results since the merger of endo closed on July 3rd.

To support year-over-year comparability in our presentation slides. We have provided Pro performance Financial results, as if the companies were combined for the entirety of the corresponding period, presented,

therefore, this information is in addition to the information included in this morning's earnings release which we encourage you to also review

The performance results also exclude malen, cross Tara cost business and then those International pharmaceutical business and do not reflect the impact of potential synergies or in the case of Park House, the additional cost required to operate the business on a standalone basis.

Was completed today. The primary focus of our discussion will be on speaking of a result.

Our health has separately published its third quarter results this morning.

Turning to slide 7 and the third quarter financial highlights.

Performant net total. Net sales for the company in the third quarter of 2025 were $869 million, an increase of 3% compared to $800.45 million in the third quarter of 2024.

Proform and sales to kinova in the third quarter of 25 were 480 million and increase of 10% compared to 435 million in the third quarter of 2024 primarily driven by the strong performance of AAR.

389 million, a decrease of 5% compared to 410 million in the third quarter of 24.

ProForm just a bit up for the company in the third quarter of 25 was 129 million compared to 268 million in the third

quarter of 24.

So in the third quarter of 25 was 52 million compared to 143 million in the third quarter of 2014.

This decrease was primarily due to $123 million in compensation expenses. In the quarter related to the merger of small.

You upset by growth in Africa.

Excluding compensation expenses, so formal adjusted with that, increased by 25 million.

For former Justice. EBA Health in the third quarter of 25 was 77 million compared to 125 million dollars in the third quarter of 24,

Now, let's take a closer look at kenova's performance.

Net sales of a gel in the third quarter of 25 where 181 million and increase of 44% compared to a 126 million dollars in the third quarter of 2014.

This growth is a reflective of strong category expansion.

A broader and deeper prescriber base as 30% of the actor. Prescriber base was new to the category.

Accelerated adoption of discharge. Check device with self-checked accounting for 84% of all new, repeller routes in the quarter.

And enhance. Patient. Affordability.

Turning to drylux.

Net sales in the third quarter of 2025 were $130 million, an increase of 2% compared to $128 million in the third quarter of 2024.

As 3D mentioned, in the third quarter of 2025, Z Flex growth was negatively impacted by an unexpected delay in certain shipments, which were moved from the third quarter to the fourth quarter.

With the respect to the remaining portfolio. Would note that in the third quarter of 25 net sales. So kind of Max were 59 million, a decrease of 8% compared to the prior year quarter driven by competitive pressures in the US partially offset by 19% growth in Japan.

Let's say it's a Percocet, where $15 million is a decrease of 37% versus the prior year quarter. That was largely due to a formulation status change in the quarter by a major player.

Turning to guidance.

As a result of a gel continued strong performance in Q3, we are raising 25 full year. Net sales, growth guidance for AAR, from a 20 to 30% range to a 30 to 35% range.

In addition we are updating net sales, growth guidance for zylex.

From Em High single digit, range to emit, single digit rates.

We are raising full year 2025 performance at sales and adjusted T guidance for Kenova compared to the implied guidance for the Branded business previously provided. But in August

The updated guidance excludes health to resolve.

We now expect performance at sales to be between 1.87 and 1.89 billion dollars.

And perform a just to give you that to be between 500 and 55, and 515 million inclusive of approximately 135 million dollars in compensation expenses related to the merger of mine included expensive for the 3 year.

This updated full-year guidance reflects expected fourth quarter 2025 net sales of $485 million to $500 million.

And adjusted of 155, 265 million dollars, inclusive of approximately, 10 million dollars of expected transaction. Related compensation, expenses in the fourth quarter.

Lastly, I see you noted. We remain on track to realize approximately 75 million of free tax, 1 rate synergies. In the first 12 months post the merger and at least 150 million dollars of annual pre-tax 1 rate synergies by year. 3 post merger primarily driven by the integration of business functions and savings from economies of scale among other areas.

And the call back to see you for closing remarks.

Thank you, Cristiana.

Ask me introduce kinova to the investor Community. I want to say that I'm deeply proud of our teams and the incredible work they have done this year.

We have a tremendous opportunity ahead and we look forward to keeping you informed of our progress.

And with that, I will now open the floor for Q&A.

Thank you, and a very quick reminder to ask a question. Please press *1, 1 on your telephone and wait for your name to be announced to address your question. Please press *1, 1 again. One moment while we compile our Q&A roster.

I'm showing no questions at this time and I would like to hand the conference back over to Gerard mutchner for closing remarks.

Thank you, thanks Siggy, and Cristiano, and thank you. All again 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 via email.

And we will work to get back to you as soon as possible. Thank you.

This concludes today's conference call. Thank you for participating, and you may now disconnect.