Amneal Pharmaceuticals, Inc. (NYSE:AMRX) Q2 2023 Earnings Call Transcript

Amneal Pharmaceuticals, Inc. (NYSE:AMRX) Q2 2023 Earnings Call Transcript August 4, 2023

Amneal Pharmaceuticals, Inc. beats earnings expectations. Reported EPS is $0.19, expectations were $0.1.

Operator: Hello, everyone and welcome to the Amneal Pharmaceuticals Second Quarter 2023 Earnings Conference Call. My name is Bruno, and I’ll be operating your call today. [Operator Instructions] I will now hand over to your host, Anthony DiMeo, Head of Investor Relations. Please go ahead.

Anthony DiMeo: Good morning, and thank you for joining Amneal Pharmaceuticals second quarter 2023 earnings call. Our Q2 earnings press release and presentation are available at amneal.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 our SEC filings for a discussion of factors that may impact our future performance. We also discuss non-GAAP measures. Information on our use of these measures in reconciliation to U.S. GAAP are in the earnings presentation.

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On the call today are Chirag and Chintu Patel, Co-Founders and Co-CEOs; Tasos Konidaris, 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 Chirag.

Chirag Patel: Thank you, Tony, and good morning, everyone. Q2 was another strong quarter with $599 million of revenue, growing 7%, adjusted EBITDA of $146 million, growing 9% and net leverage at 4.9x. As a result of our solid momentum in the first half, we are pleased to be raising our full year 2023 guidance. On a personal note, this earnings call marks 4 years since Chintu and I returned to Amneal as Co-CEOs. At that time, we stated our goal was to return Amneal to growth and build a world-class diversified pharmaceutical company, driven by our purpose to provide access to high-quality and affordable essential medicines. Since then, we have methodically executed our long-term strategy to expand into high-growth and high-impact areas.

Today, Amneal has a diversified portfolio of approximately 270 marketed products, an industry-leading R&D engine, excellent commercial capabilities, a foothold in key global markets and significant growth catalysts ahead. We have delivered strong financial performance each year since 2019 as revenues have grown 10% and adjusted EBITDA has grown 12% on a CAGR basis. Further, we have reduced net leverage from 7.4x in 2019 to 4.9x currently, well on our way to below 4x by the year 2025. Based on the strength of our diversified portfolio, robust capabilities and opportunities ahead, Amneal is well positioned to drive sustainable long-term growth, accelerate profitability and continue deleveraging. Let me now walk through how we are executing our strategy across the business.

In the Generics segment, we have retail generics, injectables, biosimilars and international business. We expect Generics revenue growth will accelerate over the next several years, driven by complex products. Approximately 55% of a generics revenue is expected to come from complex products in 2023 compared to 35% in 2019. And we expect that mix shift will continue. So, first, in retail generics, we are expanding our portfolio of approximately 230 products to move up the value chain of complexity. As we have discussed, complex generics tend to have less competitors and drive more durable growth, revenues and profit. As shown on the catalyst slide, we expect to advance over a dozen high-value complex generics to the finish line by 2024. Second, in injectables, our goal is to be a top 5 U.S. business and a global player.

Our strategy centers on being a key supplier of an expanding portfolio and offering a resilient supply chain in a market plagued by product shortages. Currently, we have about 30 injectables with over 30 new launches planned by 2025. With our recently added sites, we now have 4 injectable facilities to produce at scale across multiple formulations. As we ramp up production at our new facilities and launch new products, we expect the next inflection of injectables revenue in 2024 building to over $300 million by 2025. Third, in biosimilars, our first three oncology products are seeing strong uptake, particularly ALYMSYS, which is running ahead of our expectations. ALYMSYS and RELUEKO launched in Q4 2022 and FYLNETRA launched in May. Our biosimilars team has done an excellent job building the commercial infrastructure and establishing a market presence in the first year.

Through June, we have continued to add customers, and we now have 400 infusion locations, particularly oncology clinics. Most notably, ALYMSYS market share based on dollar value is at 4% as of June, only 2 quarters after having Q-Code. We now expect about $60 million in biosimilars sales this year. We are well on our way to achieving over $200 million in peak sales by 2025. Also, we look to add 2 to 4 additional biosimilars to the pipeline in 2023 and ‘24, which have the potential to commercialize starting in 2025. We are committed to being a leader in biosimilars for long-term. Internationally, we are utilizing our U.S. FDA-approved portfolio to expand globally. In India, we are leveraging our local infrastructure and expanding our portfolio.

In other geographies such as Europe, we are working with partners to commercialize our products. Based on our initial progress, we expect international expansion will add $50 million to $100 million in revenue by 2027 and scale further over time. Next, in the Specialty segment, we are continuing to drive growth in our key branded products, Rytary for Parkinson’s and Unithroid for hypothyroidism. Touching on IPX203, we shared last month that we received a CRL requesting additional data. We plan to meet with the FDA soon to align on the pathway to approval, which Chintu will discuss further. With 1 million U.S. Parkinson’s patients, 5 million annual scripts and an unmet need for this degenerative disease, there is a much broader opportunity for IPX203.

Overall, we are focused on growing Specialty to over $500 million revenue by 2027. In our third segment, AvKARE, we see continued momentum across multiple channels, distribution, government and unit dose. We expect AvKARE will deliver around $500 million in revenue in 2023, building to over $600 million by 2025. Overall, we see strong momentum across our diversified global pharmaceuticals company. Our business does not rely on any 1 product. Each quarter, we are adding new complex therapies to expand our reach and impact on patients. As we execute and build on our sustainable growth profile, we expect to drive revenue growth and meaningfully higher levels of adjusted EBITDA. I will now pass it to Chintu.

Chintu Patel: Good morning. Thank you, Chirag, and thank you to the global Amneal family who worked hard every day to advance our mission of making healthy possible for patients. As Chirag discussed, we have been focused these last 4 years on building an innovative, well diversified and differentiated global pharmaceuticals company capable of driving sustainable growth in key areas of medicine. We are very excited about our strong performance in the first half of 2023 and the outlook ahead. I will touch on how our operational excellence, highly productive R&D engine, resilient supply chain and expanded capabilities continue to propel our success. First, we remain focused on driving operational excellence and efficiency. As an example, we are in the process of moving production for about 30 products to lower-cost locations, and we are continuously evaluating opportunities to bring cost down.

In addition, we have strengthened our global supply chain by expanding our infrastructures in key areas, adding redundancy and resiliency of our operations. Importantly, our global operations are at scale to support long-term growth. Most notably, we see the benefit in injectables, where today, we have 4 facilities with 19 production lines. Over the last few years, we have doubled our injectables capacity. At the same time, the overall injectables market continued to face chronic supply shortages. As we look at our commercial portfolio and pending ANDAs, 16 products are on the U.S. FDA shortage list with additional 12 our pipeline. Amneal is well positioned with our expanded supply chain and capacity to help address drug shortages in the United States.

In addition, we expand our footprint and build our capabilities. We are committed to maintaining our quality track record. Since 2005, the U.S. FDA has conducted 95 successful inspections, including 4 this year with no observations or minor 483s. Moving to generics R&D. We have made tremendous progress diversifying our portfolio with new complex medicines. We have launched 18 new products so far this year, and we are on track to launch over 30 new products in 2023. Overall, we have 92 ANDAs pending FDA approval, with 61% representing non-oral solid products. This includes 29 injectables, 11 ophthalmics, 9 topicals and 4 inhalation products. Behind that, we have 67 pipeline products with 90% being non-oral solids. With our well-established and diversified portfolio, we have incrementally shifted our focus to high-value complex categories.

In fact, 40% of pending ANDAs and 70% of our pipeline are expected to be first-to-market, first-to-file or 505(b)(2) opportunities. Most recently, we announced the ANDA filing of 3 complex generics, including generic Proair in inhalation, bimatoprost in ophthalmics, and propofol emulsion in injectables. These products are indicative of the high-value R&D programs we are most focused on. In Injectables, we have launched 6 new products year-to-date. In July, we launched our first LVP bag magnesium sulfate from one of our 2 new injectable facilities and Plerixafor and oncology injectables. We are advancing a number of other complex injectables and expect to file our first 2 505(b)(2) ready-to-use bags in Q3. We expect a strong cadence of new injectables in 2023 and 2024, including the launch of PEMRYDI RTU in January 2024.

We are very excited about the opportunity ahead in injectables for Amneal. After injectables, we see inhalation and Amneal’s next key growth area in complex generics. We have two key metered dose inhaler ANDAs pending with generic QVAR and generic Proair. Both are expected to launch in 2024 upon approval. Other high-valued MDI programs are in development as well. Further, we are developing several Respimat inhalation devices utilizing the Soft Mist technology platform. Let me now highlight key launches currently underway. First, we launched an authorized generic version of Xyrem in July. Second, we are set to launch Lisdexamfetamine, a key ADHD medicine in Q3. Third, our pending ANDA for generic Narcan is under priority review. We are very passionate about this over-the-counter product, which will improve access to a critical life-saving opioid overdose treatment.

A broader list of our notable planned launches is included on our catalyst slide. Next, in biosimilar, we are very excited about the potential for Amneal in this space. Our first oncology biosimilars are seeing excellent uptake and there is a compelling opportunity to expand our portfolio through partnerships for further molecules. We see biosimilar as a key long-term growth driver. Turning to specialty R&D, we continue to work to advance our 505(b)(2) pipeline. As we disclosed, the CRL we received for IPX203 requested additional data related to the scientific breach for the safety of carbidopa. We expect to have a Type A meeting with FDA in the next few weeks. We look to provide data necessary to address the comments and launch IPX203 following approval.

We continue to see IPX203 as an innovation that advances the standard of care with a broad appeal for Parkinson’s patients. In summary, we are driving operational excellence and executing on our innovation strategy, which together are fueling our ability to drive sustainable growth. I will now hand it over to Tasos.

Tasos Konidaris: Thank you, Chintu. Good morning. I’ll start first with our Q2 results, move on to our year-to-date strength and then raising our full year 2023 guidance. First, we’re very pleased with the performance of all our business segments in driving strong financial performance for another quarter. In the second quarter, total net revenue of $599 million grew 7%, adjusted EBITDA of $146 million grew 9%, and adjusted diluted EPS of $0.19 was in line with prior year. Our Q2 Generics net revenue of $374 million was up 9% sequentially and up 2% versus prior year. Growth was driven by Adrenaclick, Zafemy, multiple new product launches and strong commercial execution by our biosimilars team. New products launched in 2022 and 2023 added $24 million to Q2 revenue growth.

As the year develops, we expect robust performance across our Generics segment as new product launches ramp up, biosimilars become a larger part of our business and our global supply and commercial teams work hard to ensure continuity of supply and market share growth. As we have said in the past, Amneal is now a much more diversified company than ever before, which allows us to deliver consistent financial outcomes despite the typical ups and downs. Furthermore, as our portfolio continues to shift towards more complex products, our ability to deliver increased levels of growth and profitability grow substantially. Moving on to our Specialty business, where in the second quarter, net revenue of $97 million was up 6% sequentially and flat with the prior year.

Growth was driven by Unithroid, which grew 17% sequentially and 24% versus prior year. Rytary revenue was impacted by timing and was down 2% sequentially and down 4% versus prior year. Having said that, Rytary total prescriptions are up 4% versus prior year, which bodes well for revenue growth in the back half of the year. Our AvKARE business continues to perform exceedingly well with Q2 net revenue of $128 million, up 5% sequentially and 32% compared to the prior year. Growth was driven across all lines of business, which includes distribution, government and unit dose. Improved product flow, pricing and strong execution have led to a substantial increase in profitability. We expect that the strong momentum in AvKARE will continue to reach about $500 million in revenue in 2023, up from $406 million in 2022.

As expected, Q2 2023 adjusted gross margin of 43% was substantially higher than the 39% of the first quarter of 2023, albeit 1% below prior year. It is also worth noting that consistent with our earnings call in May, Generics adjusted gross margin grew substantially to 43% in the second quarter compared to 37% in the first quarter, a 600 basis point sequential improvement. Q2 adjusted EBITDA of $146 million increased sequentially by $30 million, or 26%, and $12 million, or 9%, compared to prior year. Performance reflects strong revenue growth, solid gross margins and operating expense leverage. As we have said in the past, our overall business is pretty much at scale, which provides strong operational leverage and bodes well for increased levels of profitability as revenue grows over time.

Q2 adjusted diluted EPS of $0.19 was up $0.07 sequentially and flat to prior year, reflecting our adjusted EBITDA growth, along with higher interest expense. Let me now spend a moment on our Q2 year-to-date performance, where our teams are delivering strong performance across all our business segments. Year-to-date, top line is up 9% as Generics grew 5%, Specialty grew 4% and AvKARE grew 30%. Strong operating expense focus has allowed us to invest in new areas like biosimilars, while delivering year-to-date adjusted EBITDA growth of 12% and adjusted EPS growth of 3%. Furthermore, we feel really good about our cash generation as we generated operating cash flow of $128 million year-to-date compared to minus $5 million last year, an increase of $134 million.

As we shared with you in the past, with the company’s increased profitability in many of the investments to expand our portfolio and infrastructure already in our place, puts us in a good position to further reduce debt. At the end of Q2, our net leverage was 4.9x, which is substantially below the 5.5x at the end of Q2 of last year and 5.3x at the end of 2022. In addition, in July, we paid down an additional $30 million in gross debt, and we are targeting net leverage below 4x by the end of 2025. Let me now turn to our full year guidance. And as you may have seen in our press release this morning, we are raising our full year 2023 expectations to reflect the strength of our year-to-date performance across all segments of our business. From a revenue perspective, we now expect net revenue of $2.3 billion to $2.4 billion in 2023, up $50 million from the prior range.

Our accelerated revenue growth outlook reflects mid to high single-digit revenue growth for 2023. Due to the strength of revenue, we are raising our 2023 adjusted EBITDA guidance range from $525 million to $540 million, up about $20 million from the prior range of $500 million to $530 million. We’re also raising 2023 adjusted EPS guidance to $0.45 to $0.55, up $0.05 from the prior range of $0.40 to $0.50. We’re also raising our 2023 operating cash flow guidance to $220 million to $250 million, which is an improvement of $20 million compared to the prior range of $200 million to $230 million. This range includes interest expense and excludes legal settlement costs of about $90 million, mostly related to the Opana ER case. I think it is also important to note that we expect continued momentum in 2024 and beyond.

And with that, let me turn it over back to Chirag.

Chirag Patel: Thank you, Tasos. Our diversified portfolio of essential medicines is driving strong results. We expect our momentum and profitability acceleration will build in 2024 and beyond, driven by catalysts happening now, including biosimilars and new complex generics launches on the horizon. We said it would be a long-term journey to strategically reposition the company for sustainable long-term growth. That journey is at an inflection point as Amneal 2.0 is hitting its stride now. We will now open the call for Q&A.

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Q&A Session

Operator: [Operator Instructions] Our first question comes from Nathan Rich from Goldman Sachs. Nathan, your line is now. Please proceed.

Nathan Rich: Great. Good morning, and thanks for the questions. Maybe starting with biosimilars. You talked about ALYMSYS running ahead of expectations. Can you talk about maybe where you’ve been kind of successful in the market in terms of picking up that early share? And then, when it comes to future biosimilar opportunities, are you looking to stay in the oncology and kind of provider-administered space? Or do you see yourselves kind of looking at some of the self-administered products that go through the pharmacy channel? I’d just be curious to get your thoughts on relative attractiveness between the two.

Chirag Patel: Thanks, Nathan. So, biosimilars is a long-term journey and long-term play. As you know, more than 70 biologics products will become biosimilars over the next 10 years. And it’s not just a U.S. play, it’s also a global play, providing the more excess and affordability. The number one reason why we have been successful is, we have built a solid commercial team. And I have Mr. Harsher Singh here, who leads our team, which will provide more details without giving any confidential information to competitors how we did it. I’ll pass it on to you, Harsher, hold on. The onco – so your second question was where do we play? Right now, we are in oncology, and we will continue to add more products and add related products within oncology as well.

But we are evaluating the pharmacy benefit products in immunology and other categories because to play biosimilars for the long-term, we would have, obviously, like to have leadership in oncology but also have additional products as we mature our biosimilar portfolio. So thank you, Nathan. I’ll pass it on to Harsher on Commercial success.

Harsher Singh: Nathan, thank you for your question. The short answer here is, we’ve done disproportionately well in the oncology segment, largely because they are more likely to change and more able to change their prescription behavior over a shorter time frame. We expect to continue that success both in oncology and in the hospital segment in the coming quarters. We like buy and build, and we hope to remain winners in that segment.

Chirag Patel: Thank you, Harsher.

Nathan Rich: Great. Thanks for the comment. If I could just ask a quick follow-up on the guidance. The EBITDA increase, I think, was a little bit lower than we would have expected just given the 2Q results and the updated revenue guide. So, Tasos, I just wanted to see if there was anything to call out there as we think about EBITDA cadence? Or is that kind of just embedded conservatism over the balance of the year?

Tasos Konidaris: Yes. We will try to be as conservative as we can. That’s number one, so that we were put in a position to meet all our commitments and hopefully exceed. So, I wouldn’t read anything more than that. There is still 6 months to play. We feel great about the growth so far, which, as I mentioned before, record revenues, record EBITDA, up 9% and 12%. We will see how the rest of the year plays, but we feel really good about exiting the year in a very strong position in a really great trajectory for 2024 and 2025.

Nathan Rich: Great. Thank you.

Operator: Our next question comes from David Amsellem from Piper Sandler. David, your line is now open. Please go ahead. David, your line is now open. Please go ahead with your question. Okay. I think we lost connection with David. Our next question in line comes from Balaji from Barclays. Balaji, your line is now open. Please proceed.

Unidentified Analyst: Good morning, everyone. This is Mahila on for Balaji. Thanks for taking our questions. Just wondering what your latest thinking on generic pricing trends is? And can you specifically talk about price erosion for the injectables business? Thanks so much.

Tasos Konidaris: Hey, Mahila, good morning, this is Tasos. So, overall, we’re seeing an improved pricing environment. So, still prices continue to decline, just the rate of decline is lesser than prior year. And that obviously creates less of a headwind for us and a good thing for an industry that is trying to be helpful with the shortages and increase kind of compliance requirements from a regulatory perspective. So that’s kind of the high-level pricing comment. On injectables, and that’s an area that we like, we see less of a pricing pressure than the oral solids. And as a result, the profitability of that segment is higher than the typical orals. So this is why that’s an area of focus for us, and that’s why our pipeline disproportionately favors injectable products, which will help drive increased level of profitabilities for the next few years.