3/1/2024

speaker
Operator
Conference Operator

Ladies and gentlemen, thank you for standing by. The Amniel Pharmaceuticals fourth quarter and full year 2023 earnings call will begin shortly. If you would like to register a question at any time, please press star one on your telephone keypad. Thank you. Good morning and welcome to Amniel Pharmaceuticals' fourth quarter and full year 2023 earnings call. And I'll turn the call over to Amniel's Head of Investor Relations, Tony DiMeo.

speaker
Tony DiMeo
Head of Investor Relations

Good morning, and thank you for joining Amniel Pharmaceuticals' fourth quarter 2023 earnings call. Today, we issued a press release reporting Q4 and full year 2023 results. The earnings press release and presentation are available at amdeal.com. Certain statements made on this call regarding matters that are not historical facts, including but not limited to management's outlook or predictions, are forward-looking statements that are based solely on information that is now available to us. Please see the section entitled Cautionary Statements on Forward-Looking Statements in the Earnings Presentation and SEC Filings for Factors that May Impact Future Performance. We also discussed non-GAAP measures. Information on use of these measures and reconciliation to U.S. GAAP are in the earnings presentation. On the call today are Chirag and Chintu Patel, co-founders and co-CEOs, Tasos Konideres, CFO, Our commercial leaders, Andy Boyer for generics, Joe Renda for specialty, Harsher Singh for biosciences, and Jason Daly, chief legal officer. I will now hand the call over to Shiraz.

speaker
Chirag Patel
Co-Founder and Co-CEO

Thank you, Tony. Good morning to everyone on the call. MNIL delivered solid financial performance in 2023 as revenues grew 8% and adjusted EBITDA grew 9%. We raised our guidance twice during the year and delivered on it. driven by strong execution and the robust performance across our diversified business. We expect our momentum will continue in 2024 and beyond. MNIL's core strengths lie in our broad-based business platform and our team, both of which are dedicated to providing access to high-quality, affordable, essential medicines. Since Chintu and I returned to the company in 2019, we have been implementing a thoughtful and deliberate strategy to transform MNIL into a leading global diversified pharmaceutical company. With a global aging population and ongoing supply challenges and shortages, our capabilities have never been more important and more in need. In our affordable medicines business, which is our generic segment, we have been building our leadership position since MNIL's inception. We have decades-long reputation for industry-leading innovation, quality, and customer service levels. Our strategy focuses on expanding our portfolio and driving growth with complex, high-value products across retail, injectables, and biosimilars. Our affordable medicines business has consistently grown each year since 2019, and we have launched more complex retail and injectable innovations in the United States than anyone else since then. In 2023, we set a new record number of 39 new retail and injectable products launched. In retail market, our commercial portfolio of over 230 medicines is complex and diversified with less price erosion and more stability. Overall, the U.S. generics industry appears to have turned the corner after years of higher price erosion, as many recognize the importance of the sector responsible for over 90% of U.S. medicines. In injectables, we have an expanding portfolio, significant capacity, and the capabilities needed to scale this business. We are helping address chronic shortages across hospitals and clinics, and are providing ready-to-use injectables that reduce errors and improve the efficiency of care. The next wave of affordable medicines is biosimilars, which has an estimated $141 billion in branded products facing loss of exclusivity between 2023 and 27. We successfully entered this new market with over three oncology biosimilars. That performance exceeded our revenue expectations in 2023, driven by an exceptional commercial execution in that first year. In Q4, we also expanded our biosimilars portfolio by adding two more oncology molecules to our pipeline. Given the market growth and importance of biosimilars, this is a key area of strategic focus and investment for MNIL. We look to further build out biosimilars pipeline over time. Internationally, we are expanding our reach. In India, we are building a customized portfolio focused on key local needs. In other geographies, we are actively working with partners to register and commercialize MNIL products. In our specialty branded business, we continue to provide differentiated medicines We are focused primarily on neurology and endocrinology with our key branded products. In Q4, we expanded with the addition of Ongentis, an adjunctive therapy for Parkinson's. Next, we are so excited about the potential approval and launch of IPX203 this year, which we believe meaningfully advances the standard of care for all Parkinson's patients. In our healthcare distribution business, which we acquired in 2020, the business has about doubled in size in four years. We're launching new products across three channels, distribution, government, and unit dose. In short, we're starting 2024 with remarkable momentum. We believe our durable, broad-based, top and bottom line growth profile is sustainable and accelerating. As MNILians, we wake up every day thinking about what we can accomplish next. We have more shots on goal than ever before. This includes key medicines and new markets where success represents 100 million or more in potential revenues each. MNIL is on an upward trajectory, and we are so excited for what's ahead. I'll now hand it over to my younger brother, Shintu.

Disclaimer

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