Q3 2025 Mallinckrodt PLC Earnings Call

Speaker #2: Additionally, we note that this call does not constitute an offer to sell or the solicitation of an offer to buy any securities, and any such offering would be made pursuant to the registration statement to be filed with the SEC.

Speaker #2: 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 kenova.com.

Speaker #2: 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 the website for this information.

Speaker #2: As noted in our earnings release, the third quarter for Mallinckrodt ended on September 26, 2025. Mallinckrodt's third quarter earnings report includes combined business results since the completion of our merger with Endo on July 31, 2025.

Speaker #2: Joining me on today's call are Sigurdur Olafsson, our President and Chief Executive Officer, and Christiana Stamulis, our President and Chief Financial Officer. Sigurd and Christiana will provide an overview of our new company, Kenova Therapeutics, and review our performance for the third quarter in detail.

Speaker #2: I'll now turn the call over to Sigurd.

Speaker #3: Thanks, Gerard. And good morning, everyone. This year has been nothing short of transformative for us. First, we brought together two pharmaceutical leaders with a merger of Mallinckrodt and Endo.

Speaker #3: Then, we combined our generics and sterile injectable businesses under the name Pyrehealth and announced today that we completed the spin-off of that business as a separate private company.

Speaker #3: This is an exciting day for our teams, and we are proud to introduce you to Kenova Therapeutics, a new company with a new identity and a new future.

Speaker #3: Kenova strives to develop therapeutics that help patients with rare and unaddressed conditions live happier and healthier lives. The name Kenova evokes two complementary attributes of our company: the keen focus on helping patients receive the care they deserve, and the innovation required to develop our therapeutics.

Speaker #3: Our new tagline, "Keen to solve, keen to serve," reflects our commitment to help solve the challenges our patients face and to serve them with integrity.

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

Our results for the third quarter, reflect, that kinoa 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 research related to the brand business

Where we delivered a 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 Acthar net sales in the third quarter, they increased 44% compared to the prior year quarter, marking another quarter of significant growth.

Atic continues to play a pivotal role in actor, gel's growth.

On the back of growing demands and broadening prescriber base unselfish consistently exceeding expectation. We now expect after deal, net sales growth of 30 to 35% for the full year.

Next, Fireflex net sales growth in the third quarter was 2% versus the prior year quarter, as we experienced certain unexpected shipment delays.

We are also making important progress in our scale, Flex 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 continued to advance our multi-year rollout of the evolved DS. 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 to season 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 for 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 the bride and a bright future for Kinoa.

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

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

She started my new role in September, and 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 Cova team.

before discussing the financial results for the quarter it is worth noting that as a result of the merger with indoors, the company operated in 3 reports, during the third quarter of 2025

Specialty Brands generic and sterile injectables.

Going forward. Innova comprises only the specialty brand segment while perhaps comprises the generics and sterile injectable segments

I would like to also point out that the company's third quarter earnings reports 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 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 will encourage you to also review

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

Since the park has been off, it was completed today. The primary focus of our discussion will be on speaking over resolve.

Park Health has separately, published its third quarter results this morning.

Turning to slide 7 and the third quarter financial highlights.

9 million and increase of 3% compared to 845 million in the third quarter of 2024.

Performance sales for 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.

Performance sales for part Health. In the third quarter of 2015 were 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.

ProForm just stated in the third quarter of 2025 was $62 million compared to $143 million in the third quarter of 2024.

This decrease was primarily due to 123 million dollars in compensation re expenses in the quarter related to the merger of Ming protein endo.

Partially offset by growth in Africa.

Excluding compensation expenses performer, adjusted with that, increase by 25 million.

For former Justice. EBA Health in the third quarter of 25 was 77 million compared to 125 million 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 2015, where 181 million and increase of 44% compared to 126 million in the third quarter of 24.

This growth is reflective of strong category expansion.

A broader and deeper prescriber base as 30% of the actors. Prescribe, their base was new to the category.

Accelerated adoption of digital. Check device with sales checks, accounting for 84% of all new reseller routes in the quarter.

And enhance. Patient. Affordability.

Turning to zylex.

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.

A 3D mentioned third quarter. 25 Z Flex growth was negatively impacted by an unexpected delay in certain shipments, which assisted 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 of final 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.

Net sales of Percocet were $15 million, a decrease of 37% versus the prior year quarter. This decline was largely due to a formulary status change in the quarter by a major player.

Turning to guidance.

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

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

From Mr. High single digit range to admit single digit rates.

We are raising full year 2025 performance sales and adjusted a guidance for kinova, compared to the implied guidance for the Branded business. Previously provided back in August.

The updated guidance, excludes for health to resolve.

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

And perform a justify that to be between 505 and 515 million inclusive of approximately 135 million dollars in compensation expenses related to the merger of Malin code expensive for the 3 year.

this updated full year guidance, reflects expected, fourth quarter 2525, net sales of 485 to 500 of 5 million,

Related compensation expenses in the fourth quarter.

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

And now hand the call back to CG 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 as a reminder, to ask a question. Please press star, 1, 1 1 on your telephone and wait for your name, to be announced to withdraw your question. Please press star 1 1 1 again, 1 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. You may now disconnect. Everyone have a great day.