Q3 2024 Endo Inc Earnings Call
Thank you for standing by. Welcome to the earnings conference call for endo ink. This call is being recorded. If you have any objections, you may disconnect at this time. I would now like to turn the call over to Lori Park, Senior Vice President and Vester Relations and Corporate Affairs. You may begin.
Lori Park: Thank you Emily. Good morning and thank you all for joining us to discuss Endo Inks 3rd Quarter 2020 for financial results.
Lori Park: Joining me on today's call are Scott French, N.R.M. CEO and member of the Board of Directors. Mark Bradley, Executive Vice President and CFO, and Patrick Barry, Executive Vice President and President, Global Commercial Operations.
We have prepared slide-free sentation to a company today's webcast, and that presentation, as well as other materials, are posted online in the Investor section at endo.com. Later this morning, a copy of our prepared comments will also be posted to the webcast.
I would like to remind you that any forward-looking statements made by management on today's call are covered under the U.S. private security litigation reform act of 1995. And our subject to significant changes, risks, and uncertainties described in our earnings release and other press releases and in our FCT filings.
Actual results may differ materially from those set forth in any forward-looking statements.
As previously disclosed, substantial aid all of endowed international assets were acquired by endowed ink on April 23, 2024, pursuing to endow international plan of reorganization.
Lori Park: NdoAng 3rd quarter 2024 results reflect the effects of the plan of reorganization and the application of fresh start accounting.
Lori Park: To declare a 5 during the call, all references to 3rd quarter 2024 results refer to Endo Inc. All references to 3rd quarter 2023 results refer to N1 International PLC.
In addition, during today's call, we may refer to non-gapsed financial measures that are not prepared in accordance with accounting principles generally accepted in the United States and may differ from non-gapsed financial measures used by other companies.
Investors are encouraged to review our current report on Form 8K, Furnished with the FTC, for our reasons for including those non-GAAP financial measures in our earnings release and presentation.
Lori Park: The reconciliation of non-GAAP financial measures to the most directly comparable GAAP financial measures are included in our earned release issued earlier this morning unless otherwise noted therein. I would now like to turn the call over to Scott.
Scott French: Thank you, Lori, and thank you to everyone joining us this morning. Starting with slide five. During today's call, I will provide a third quarter performance and business update, including some thoughts on the company's opportunities given my 60 days inside.
Scott French: Mark Bradley will then walk you through the financial results and outlook, and then I will return with some closing comments before we open it up to your Q&A.
Scott French: Thank you.
Scott French: Slide seven provides our third quarter operating performance and recent business highlights.
Lori Park: Third quarter 2024 total revenues of $427 million and adjusted EBITDA of $151 million were just above our pre-announced result estimates from two weeks ago, which were issued as part of our term loan repricing.
Lori Park: Compared to prior year, third quarter revenues decreased 6%, primarily attributable to the competitive pressures across the generic and sterile segments, partially offset by solid revenue growth from our branded pharmaceutical segment.
Lori Park: This is sequential improvement in performance compared to prior quarters, as the competitive impact of losing exclusivity of key products, including vasostrict and varenicline, had begun to stabilize.
Lori Park: Importantly, we are on track to deliver our full year 2024 revenue and EBITDA expectations, as well as transition to growth.
Lori Park: Our performance in the third quarter was anchored by Xyaflex.
Lori Park: with total revenue growth of 13% and strong performances across both on-market indications.
Lori Park: We also advanced our sterile injectable capabilities, including launching adrenaline ready-to-use bags during the first week of October.
Lori Park: In addition, we saw the cash generation strength of the business, adjusted EBITDA grew 6%, our net leverage was reduced to 3.3 times from 3.5 times last quarter, and we successfully completed the repricing of our $1.5 billion term loan, which I would like to thank our credit holders for their continued confidence.
Lori Park: Moving to slide 8 and driving into the segment-level performance.
Lori Park: Starting with the branded pharmaceutical segment, which represents about 50% of company revenues.
Lori Park: Segment revenues grew 7% versus third quarter 2023. This increase was primarily driven by strong Zyflex performance. Zyflex revenues were $128 million in the quarter, an increase of 13% compared to prior year.
Lori Park: This increase was driven by strong underlying demand and increased average net selling price. Volume increased approximately 7% and average net selling price increased by approximately 6% compared to the prior year.
Lori Park: During the quarter, Xyflex command improved across both indications.
Lori Park: Peyronie's disease revenues grew a very strong 16% and Dupuytren's contractual revenues grew 8% compared to the prior year. This performance reflects our continued focus on increasing patient and physician awareness as well as improving the HCP experience.
Lori Park: The remainder of the branded segment, including the established products, generated $89 million in the quarter, which was minus 1% relative to the previous year.
Lori Park: Third quarter 2024 sterile injectable revenues of $80 million were below prior year revenues of $95 million. This change was primarily attributable to the year-over-year competitive pressure related to vasostrict, as well as temporary supply disruptions in several products.
Lori Park: Importantly, we expect to see substantial resolution of the supply disruptions by the end of the year, as well as overall moderation in the impact from vaso-strict competition as we lap the erosion from loss of exclusivity.
Lori Park: Turning to slide 9.
Lori Park: Third quarter, 2024, generic pharmaceutical segment revenues were $111 million, a decrease of 18% compared to prior year. This decrease was primarily due to competition for Reneklin tablets and Dexlanzoprazole delayed release capsules.
Lori Park: It was partially offset by revenue upside from lidocaine patch the generic version of lidoderm
Lori Park: Importantly, excluding varenicline and dexlanzaprazole, the generic segment grew 6% and gross margin improvements drove approximately 200 basis points of benefit relative to the prior year.
Lori Park: Third quarter 2024 revenues from the international pharmaceutical segment were $18 million, which was essentially unchanged compared to the prior year.
Lori Park: Looking forward, I would like to highlight some of the future performance levers the business is utilizing within our branded and sterile growth pillars.
Lori Park: Turning to slide 10.
Lori Park: Zyaflex is the only FDA-approved, non-surgical, therapeutic option for patients with Peyronie's disease and Dupuytren's contraction.
Lori Park: Both conditions have low diagnosis and treatment rates, and a small increase in those diagnosis rates can have a significant impact for patients who prefer non-surgical options.
Lori Park: We are increasing our investment in a combination of branded and unbranded direct-to-consumer awareness campaigns focused on motivating potential patients to both seek a diagnosis and inquire about non-surgical treatment options.
Lori Park: We continue to be pleased by the patient activation across both indications, including the overall increase in visits to our websites and physician locators where disease-related education and tailored access to a local trained specialist increases patient adoption.
Lori Park: Increasing patient knowledge and adoption is critical for both our business and that of our healthcare practitioners. Five years ago, Pro Football Hall of Famer John Elway helped to increase awareness of Dupuytren's contracture by telling his Xyflex treatment story.
Lori Park: In the coming weeks we plan to launch a new BupyTrends Contractor PR campaign sharing a patient's Zyflex experience.
Lori Park: We believe that a high-touch provider approach focused on education and a seamless Zyflex acquisition experience will increase physician loyalty and support the preferential use of Zyflex as a non-surgical treatment option.
Lori Park: Accordingly, last month, at the annual meeting of the American Society for Surgery of the Hand, we unveiled our Mixed Reality Injection Simulator to over 300 hand specialists.
Lori Park: The simulator provides an immersive physician learning experience to help hand specialists refine their technique by allowing them to interact with physical and digital objects simultaneously.
Lori Park: We believe this technology will support injection training and help build injector confidence.
Lori Park: It is also important that we continue to advance real-world studies and provide information to help HCPs better support their patients. At the recent Sexual Medicine Society of America annual meeting, there were seven presentations related to Peyronie's disease and side effects.
Lori Park: Turning to slide 11, in addition to the growth potential for Xyoflex on market indications, we have been exploring the potential to drive Xyoflex growth by expanding into new musculoskeletal and neurological indications.
Lori Park: This morning we provided an update from our early Phase II plantar fasciitis clinical study.
Lori Park: While study participants receiving one treatment of Zyflex 0.6 mg showed numerical improvement from baseline on the pain intensity numeric rating scale compared to placebo, the difference was not statistically significant.
Lori Park: However, an initial post hoc analysis indicates that the results were clinically meaningful for a subpopulation of patients with moderate to severe pain at baseline.
Lori Park: We will now evaluate the data in more detail to determine if further clinical work in this moderate to severe patient population is warranted.
Lori Park: alongside Dupuytren's contraction.
Lori Park: The plantar indications are opportunities to expand our orthopedic platform, specifically to garner incremental presence in the sports medicine category, which is a high-growth subspecialty within orthopedics, and to do so with the synergistic utility of our ortho sales force.
Lori Park: Our other musculoskeletal and neurological indications provide similarly attractive life cycle opportunities.
Lori Park: This was a logical, clinical R&D shot on goal with very capitated risk for substantial upside.
Lori Park: and with a biologic that has long durability.
Lori Park: As I noted, we will look at the best next steps for the Plantar Fasciitis Program and also use this opportunity to take a fresh look at our full range of future indications for Xyflex, as well as assess both organic and inorganic capital allocation opportunities for the entire business.
Lori Park: Turning to slide 12.
Lori Park: Sterile, injectable, and acute care capabilities are the second critical pillar of our future growth. Over the past several years, we have evolved and expanded our pipeline and manufacturing capabilities to support the introduction of more unique products that meet the evolving needs of our customers.
Lori Park: Recently, we received the establishment inspection report for our indoor sterile site, and we are hopeful to receive final FDA approval by year end.
Speaker Change: The potential in this segment and the long-term pipeline of over 50 projects is something that I've been digging into over the last several weeks. And in my view, it is a very exciting opportunity. So I wanted to take a brief moment to outline several thoughts.
Lori Park: Currently, greater than 95% of U.S. hospitals use an endo product, and that foundation is a critical factor in our future pipeline success.
Lori Park: The opportunity in front of our sterile injectables business is to leverage our hospital footprint along with our commercial and manufacturing capabilities to provide a unique offering within the acute care segment, meaning hospital ORs, ERs, and surgical centers.
Lori Park: While the U.S. has arguably the best hospitals in the world, the operating environment within the acute care setting is subject to an ever-growing demand. This translates into greater patient volumes and expanding treatment protocols.
Lori Park: Hospitals further operate under DRG procedure-based reimbursement, which means it is ultimately up to the hospital to manage both quality of patient outcome and costs under these capitated procedure rates.
Lori Park: This is where our sterile injectable business comes into play.
Lori Park: With the provision of medications in final and finished form such as pre-filled syringes, pre-dosed bags that are ready to use, accurately measured, and most importantly, are FDA-approved medications manufactured in FDA-approved facilities.
Lori Park: Not only does this offering provide a step function improvement in the simplicity to a hospital environment, which if you've ever been to an ER, you know is subject to a great deal of complexity and time constraint, but also has the potential to reduce error rates, reduce pharmacy tech, nursing staff, and hospital labor costs as well as product waste.
Lori Park: This creates an opportunity for a hospital to achieve better patient outcomes with faster more accurate patient dosing Along with less waste for multi-dose vials and hence higher profitability under their reimbursement codes
Lori Park: Approximately 60% of our sterile injectable pipeline projects are planned and ready to use formulations that help to meet this need.
Lori Park: We recently launched Adrenaline Ready-to-Use Bags in early October, and we are pleased with the early demand for the product. Our bag is the first and only FDA-approved epinephrine IV bag prepared by a manufacturer and allows for improved time-to-treatment and workflow efficiencies.
Lori Park: We expect to launch two more sterile injectable products before the end of 2024 and plan to continue progressing our sterile injectable development pipeline.
Lori Park: Moving to slide 13.
Lori Park: Following the financial restructuring that was completed earlier this year, Endo now has a healthy balance sheet and is free of legacy overhangs.
Lori Park: Specifically, the company has significantly lower funded debt and lowered interest payments.
Lori Park: including the impact of the term loan repricing last week. Net leverage is now approximately 3.3 times, a significant improvement from prior to emergence and even decreasing quickly with a reduction from three and a half times at the end of just last quarter.
Lori Park: In addition, the company has significantly improved both its freedom to operate and its focus on value creation, having now alleviated litigation, tax, and other overhangs with legacy matters.
Speaker Change: With that, let me turn the call to Mark, who will take us through the rest of the financial discussion.
Speaker Change: Mark. Thank you, Scott. On slide 15, you will see a summary of our enterprise financial results for the third quarter 2024 compared to prior year.
Mark Bradley: As Scott previously discussed, third quarter 2024 revenue decreased compared to prior year as declines in revenue from our sterile and generics businesses were only partially offset by the strong growth in revenue from our branded business.
Mark Bradley: Third quarter 2024 adjusted EBITDA increased compared to prior year primarily due to higher adjusted growth margin and lower adjusted operating expenses.
Speaker Change: Adjusted growth margin was approximately 67% in third quarter 2024 compared to approximately 64% in the prior year.
Speaker Change: This increase was primarily driven by changes in product mix coupled with manufacturing productivity improvements primarily in our generics business compared to prior year.
Speaker Change: Adjusted operating expenses decreased compared to prior year, primarily driven by lower R&D expenses associated with certain non-recurring contractual credits that were received during the quarter.
Speaker Change: Third quarter 2024 adjusted net income was approximately $62 million compared to approximately $131 million in the third quarter 2023.
Speaker Change: This decrease was primarily due to an increase in interest and adjusted income tax expenses compared to prior year.
Speaker Change: We ended the third quarter with approximately $368 million of unrestricted cash and cash equivalents compared to approximately $294 million at the end of second quarter 2024.
Speaker Change: As Scott previously mentioned, we also ended the third quarter with a net debt-to-adjusted EBITDA ratio of approximately 3.3 times, compared to 3.5 times at the end of the second quarter.
Speaker Change: This improvement was driven by the higher unrestricted cash balance, coupled with higher adjusted EBITDA over the last 12-month period, compared to the second quarter.
Speaker Change: When looking at the statement of cash flows, I would like to highlight that cash from operations in 3rd quarter 2024 reflects the final payment of certain escrowed professional fees.
Speaker Change: incurred in connection with ENDO International PLC's plan of reorganization, which are also reflected in the $79 million decrease in restricted cash, coupled with an increase in both interest and income tax payments compared to prior year.
Speaker Change: Bye.
Speaker Change: As Scott also previously mentioned, last week we successfully completed a re-pricing of our $1.5 billion senior secured term loan. The re-pricing reduced the applicable interest rate on the term loan by 50 basis points to SOFR plus 400 basis points.
Speaker Change: All other terms remain substantially unchanged.
Speaker Change: The repricing will reduce cash interest expense by approximately $8 million annually.
Speaker Change: Advancing to slide 16, based on our third quarter performance and fourth quarter expectations, we are reaffirming our full year 2024 financial expectations for total revenues and adjusted EBITDA.
Speaker Change: As a reminder, full year 2024 financial results include the results of ENDO International PLC from January 1st through April 23rd and the results of ENDO Inc. from January 1st through December 31st.
Speaker Change: Based on third quarter results and fourth quarter expectations, we continue to expect total revenues to be between $1.72 billion and $1.78 billion and adjusted EBITDA to be between $635 million and $655 million.
Speaker Change: We are a highly cash-generative business and continue to expect a high EBITDA to pre-tax unlevered free cash flow conversion ratio.
Speaker Change: While total revenue expectations for the full year remain unchanged, based on third quarter results, we are refining our full year segment revenue assumptions for sterile injectables and generic pharmaceuticals.
Speaker Change: We now expect sterile injectables revenues to be between $350 million and $370 million and generic pharmaceuticals revenues to be between $430 million and $440 million.
Speaker Change: With respect to branded revenue assumptions,
Speaker Change: As we previously disclosed...
Speaker Change: Fourth quarter 2023 Zyflex revenues benefited from a non-recurring adjustment.
Speaker Change: approximately 14 million dollars associated with the application of the final vial wastage rebate determination.
Speaker Change: Adjusted growth margin for the full year 2024 is expected to remain unchanged at approximately 67% of total revenues.
Speaker Change: Gross margin in the fourth quarter is expected to be slightly lower than the first three quarters of the year, primarily due to the shift in product mix, mainly within the sterile and generic segments, coupled with certain credits and other adjustments that benefit at the first three quarters that are not expected in the fourth quarter.
Speaker Change: We continue to expect adjusted operating expenses for full year 2024 to be between 595 million dollars and 615 million dollars.
Speaker Change: Finally, we are on track to grow total company revenues in 2025, and we'll provide more detailed 2025 financial expectations in the normal course as part of year-end 2024 earnings in early 2025.
Lori Park: I will now turn the call back over to Scott for a few closing remarks.
Scott French: Thank you, Mark.
Scott French: Before my closing comments, I want to give a quick update on the CEO search and National Exchange listing process.
Scott French: First, we have met with impressive candidates and the board is working with deliberate speed to identify and appoint the best individual to lead the company forward. I do not have a more specific timeline to communicate at this point.
Scott French: Thank you.
Scott French: With regard to our goal of uplifting our stock to a national exchange.
Scott French: We have been actively engaged in that process and believe we will have achieved the eligibility requirements.
Scott French: to transition to the NYSE during this month. However, after consultation with our capital markets advisors, we have decided to defer the timing of our NYSE uplifting from the very end of 2024 to an appropriate date in 2025.
Scott French: Turning to slide 18 and closing our comments.
Scott French: Our on-market Zyflex indications are showing strong growth, with meaningful future opportunities to increase diagnosis and treatment rates, along with the potential for additional musculoskeletal or urological indications to expand the longer-term growth profile of our biologic.
Scott French: With regards to our injectable solutions and acute care platform, we believe Endo has a significant advantage in a complex and high barrier to entry market with the potential to generate attractive future revenue growth.
Scott French: We have a healthy balance sheet, strong cash flow, and the opportunity to now deploy those cash flows towards both organic and inorganic growth drivers.
Scott French: Thank you.
Speaker Change: Finally, over the past two months, I have met many of the ENDO team members and appreciate the commitment they bring to work every day.
Speaker Change: I want to thank them for their hard work and their service to our customers and their patients.
Lori Park: I'll now turn the call back over to Lori to manage Q&A. Thank you, Scott. Emily, can we have our first question, please?
Emily: 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 touchtone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press star followed by the 2.
Emily: If you are using a speakerphone, please lift the handset before pressing any keys. One moment please for your first question.
Emily: Once again, if you have any questions, please press star followed by the 1.
Speaker Change: At this time we have no questions. Please proceed.
Speaker Change: Hi, thanks for taking my questions. First, on the plant, and I apologize, I've been moving around between calls, but given the announcement that you put out this morning in terms of the primary endpoints on Phase 2, I noticed that you moved the launch date up from 2029 to 2028.
Speaker Change: Any reasons for that change, and are you making any changes to your target focus as it relates to this particular indication post this Phase 2?
Speaker Change: Hey, Rishi, it's Lori. You know what? That is an error on my part on that, and the change date is not changed.
Speaker Change: Okay. And then in terms of, you know, in the second quarter presentation, you did provide some estimates around 2025. Are we to assume that that still holds in this quarter? And then I just want to confirm that your assumptions for 2025 will just mostly just shift into being a benefit in 2026?
Speaker Change: Thanks Rishi for the questions Mark. You know we we aren't providing any updates to 2025 at this time. We will provide that in the ordinary course in early 2025 in connection with our 2024 final results.
Speaker Change: Thank you.
Speaker Change: At this time we have no other questions, please proceed.
Speaker Change: Thank you for joining us this morning. We look forward to providing updates as we move forward and we hope everyone has a good day. Thank you.
Speaker Change: Ladies and gentlemen, this concludes the conference. You may now disconnect your lines.
Speaker Change: Thank you for watching.