Q2 2025 Amneal Pharmaceuticals Inc Earnings Call

Speaker 1: Good morning and welcome to the Amneal Pharmaceuticals second quarter 2025 earnings call. I will now turn the call over to Amneal's Head of Investor Relations, Tony DiMeo.

Good morning and welcome to the Amil. Pharmaceuticals second quarter 2025 earnings call.

I will now turn the call over to amil's head of investor relations, Tony deyo.

Tony DiMeo: Good morning and thank you for joining Amneal Pharmaceuticals second quarter 2025 earnings call. Today, we issued a press release reporting Q2 results. The 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 "Collationary Statements on Forward-Looking Statements" for factors that may impact future performance. We also discussed non-GAAP measures. Information on use of these measures and reconciliations to GAAP are in the earnings release and presentation. On the call today are Chirag and Chintu Patel, Co-Founders and Co-CEOs. Anastasios Konidaris, CFO, our commercial leaders; Andy Boyer for Affordable Medicines; Jill Renda for Specialties; and Jason Daley, Chief Legal Officer.

Good morning, and thank you for joining and Neil Pharmaceuticals second quarter 2025 earnings call. Today, we should a press release supporting Q2 results.

the earnings press release and presentation are available at amu.com

Certain statements made on this call regarding matters that are not historical facts including but not limited to Management's outlooks 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.

Factors that may impact future performance.

We also discussed non-gaap measures.

Information on use of these measures in reconciliations to gaap are in the earnings release and presentation.

Tony DiMeo: I will now hand the call over to Chirag.

Anastasios Konidaris: Thank you, Tony. Good morning, everyone. The second quarter was another consecutive quarter of strong performance and growth, with revenues of $720 million and an adjusted EBITDA of $184 million. At the halfway point of the year, and with confidence in our outlook, we are pleased to raise 2025 guidance. I am so excited to walk you through the multiple growth drivers that are shaping the future of Amneal. At Amneal, we focus each day on delivering innovative and affordable medicines that are essential for patients. Since our founding in 2002, we have methodically diversified beyond generics to build a broad and differentiated portfolio of branded and complex products. Amneal has stood out from the pack by generating consistent growth in each of the last six years, and we expect growth will continue in the years ahead.

On the call today, Archer Rock and chintu. Patel co-founders and co-ceos kundera, CFO? Our commercial leaders, Andy ber for affordable medicines, Joel Rena for specialty. And Jason Daly, Chief legal officer. I will now hand the call over to Shara. Thank you Tony. Good morning everyone. The second quarter was another consecutive quarter of strong performance and growth.

With revenues of 720 million and adjusted in rid of 184 million, at the halfway point of the year and with confidence, in our Outlook, we are pleased. Today is 2025 guidance.

I'm so excited to walk you through the multiple growth drivers, the shaping, the future of ammo.

And annual we focus each day on delivering Innovative and affordable medicines that are essential for patients.

since our founding in 2002,

The broad and differentiated portfolio of branded and complex products.

Emil has stood out from the pack.

Anastasios Konidaris: In the process, we have transformed Amneal and have entered the most exciting chapter yet. In this new chapter, there are a number of new growth drivers, including Rytary for Parkinson's disease, Kynmobi Autoinjector for severe migraine, new biosimilars such as biosimilar of Xolair, our continued cadence of 20-30 new generic launches each year, particularly complex products including unique 505B2 injectables for hospitals, and our GLP-1 opportunity with Kriya. These new medicines and new opportunities are designed to create substantial value by one, advancing the standard of care and increasing access to medicines for patients; two, further expanding and differentiating our portfolio for providers; and three, adding to our growth story for investors. Over time, Amneal has strategically evolved from generics to innovative and complex medicines, and we are entering our new next phase of growth with strong momentum and clear confidence in growth ahead.

By generating consistent growth in each of the last 6 years and we expect growth will continue in the years ahead.

In the process, we have, transformed amno, and have entered the most exciting chapter yet.

In this new chapter, there are a number of New Growth drivers.

Including tracks on for Parkinson's Disease.

Breakout auto injector for severe migraine.

New bar similar such as bio simulator of Zur.

Our continued Cadence of 2030 new generic launches each year.

particularly complex products including unique 5 5B to injectables for hospitals and our glp1 opportunity with Mets, Sarah

These new medicines and new opportunities are designed to create substantial value by 1 advancing, the standard of care and increasing access to medicines for patients. 2 further, expanding and differentiating your portfolio for providers and 3 adding to our growth story for investors.

Over time and meal has strategically evolved from generics to Innovative and complex medicine.

Anastasios Konidaris: First, in our specialty segment, the launch of Rytary for Parkinson's disease continues to exceed our expectations. In the first year of the launch, uptake has been very strong, with the U.S. market share about 2% and on track for over 3% by the end of the year. Notably, about 80% of Rytary scripts are coming from IR patients, which is a strong indicator of our successful strategy to pursue the broader Parkinson's market. The patient testimonials have been inspiring, and we have highlighted a few in our earnings presentations. We are highly confident that Rytary will achieve U.S. peak sales of $300 million to $500 million. Let me now turn to our newest specialty branded product, Bracia Autoinjector, which received U.S. FDA approval in May.

And we are entering our new next phase of growth with strong momentum and clear confidence in growth ahead.

First in our specialty segment, the launch of cracks on for Parkinson's Disease continues to exceed our expectations in the first year of the launch. Uptake has been very strong with us market share about at 2% and on track for over 3% by the end of the year.

Notably, about 80% of cracks on scripts are coming from IR patients.

Which is a strong indicator of our successful strategy to pursue the broader Parkinson's Market.

The patient, testimonials have been inspiring, and we have highlighted a few in our earnings presentation.

We are highly confident that cracks on will achieve us peek sales of 300 million to 500 million dollars.

Anastasios Konidaris: Bracia is the first and only autoinjector form of DHE, a therapy that has been trusted for over 70 years for the acute treatment of migraine and cluster headaches in adults. In the migraine treatment landscape, there is a significant unmet need for patients who do not respond to existing therapies. This new product gives patients sustained headache relief when they need it the most and eliminates the need for time-consuming hospital visits. We are excited to launch Bracia with a commercial rollout in October. We continue to see this as a $50 million to $100 million peak sales opportunity. Second, in GLP-1 therapies, we are advancing our partnership with Maxzeta to help deliver innovative therapies at scale. Amneal Pharmaceuticals is Maxzeta's preferred global supplier for developed markets, including the U.S. and Europe. We will also commercialize their products in 20 emerging markets, including India.

Let me now turn to our newest, newest specialty. Branded product break here auto injector, which received us FTA approval. In May

Break. Here is the first and only auto injector form of DHE. A therapy that has been trusted for over 70 years for the acute treatment of migraine and cluster headaches in adults.

In the migrant treatment landscape, there is significant unmet need for patients, who do not respond to existing Therapies.

This new product gives patients sustained headache relief when they needed the most and eliminates the need for time, consuming hospital visits.

We are excited to launch break here with a commercial roll out in October. We continue to see this as a 50200 million Peak sales opportunity.

Anastasios Konidaris: We see GLP-1 therapies as a long-term opportunity, and we look forward to sharing more on this key catalyst over time. Third, in our affordable medicines segment, growth continues to be fueled by our diversified portfolio of complex products and the addition of new differentiated offerings. Broadly, we continue to see favorable macro trends across all three pillars: retail generics, injectables, and biosimilars, and remain confident in our ability to execute, advance new innovations, and drive sustainable growth long term. Within biosimilars specifically, we see a favorable long-term outlook for the U.S. market. Over the next decade, the number of biologic patent expirations is expected to double compared to the past 10 years, creating a significant opportunity as approximately 90% of these products do not have biosimilars in development.

Second in glp 1, we are advancing your partnership with meds Sarah to help deliver Innovative therapies at scale, mnil is Mets. Sera's preferred Global Supply for developed markets, including the US and Europe. We will also commercialize that products in 20 markets including India, we see glp ones as a long-term opportunity and we look forward to sharing more on this key Catalyst over time.

Heard in our portable medicine. Segment, growth continues to be fewer by our Diversified portfolio of complex products and addition of new differentiated offerings broadly we continue to see favorable micro Trends across all 3 pillars, retail generics injectables and biosimilars and remain confident in our ability to execute Advanced new Innovations and drive sustainable. Sustainable growth. Long term

Within bio similar specifically. We see a favorable long-term outlook for the US market over the next decade. The number of biologic patent expirations is expected to double compared to the past 10 years.

Anastasios Konidaris: At the same time, development timelines and costs are trending lower, with fewer phase three study requirements and generally less competition per molecule, excluding some of the largest biologics such as Humira and Stelara. Against this backdrop, our biosimilars in-licensing strategy has enabled us to build an initial portfolio. With three biosimilars already commercialized and five more in development, we anticipate having six marketed biosimilars across eight presentations by 2027. Specifically, biosimilar Xolair represents our largest biosimilar opportunity to date. As we have said in the past, our strategic intention is to be vertically integrated in biosimilars over time. Finally, performance in the healthcare segment continues to be driven by a broad portfolio of products and new launches delivered across three distinct channels: government, distribution, and unit dose. This business, which adds stability and diversification to Amneal's portfolio, is expected to drive revenue of over $900 million by 2027.

So, creating significant opportunity as approximately 90% of these products. Do not have biosimilars in development.

Development, timelines and costs are trending lower with fewer phase 3 study requirements and generally less competition per molecule. Excluding some of the largest biologics such as humida and Stella.

Against this backdrop, our biosimilar is in licensing. Strategy has enabled us to build an initial portfolio with 3 bar similars already commercialized and 5 more in development. We anticipate having 6 Market advisors across 8 presentations by 2027

Specifically biosolar represents our largest biosimilar opportunity to date as we have said in the past, our strategic intention is to be vertically integrated in BIO symbols over time. Finally performance. In the AFC, segment continues to be driven by a broad portfolio of products and new launches delivered across 3.

Distinct channels, government distribution, and unit dose.

Anastasios Konidaris: In summary, Amneal has a diverse array of growth drivers that build upon our distinct market position, drive sustainable value creation, and improve access and care for patients. Our strategic goal is to be America's number one affordable medicines company, and we are well on our way. I will now turn it over to Chintu. Thank you, Chirag, and good morning, everyone. Let me begin by expressing my deep appreciation to our Amneal team. Your passion, resiliency, and unwavering commitment continue to drive Amneal forward as a deeply purpose-driven company. This morning, I will provide an update on our strategic priorities across operations, innovation, and expanding portfolio, and how these are translating into strong execution and sustained performance in 2025. First, in operations, our global high-quality manufacturing infrastructure remains a key competitive advantage. Amneal continues to be recognized for its quality track record and industry-leading reliability.

This business which adds stability and diversification to amnesia's portfolio is expected to drive revenue of over 900 million dollars by 2027.

In summary, Amneal has a diverse array of growth drivers that build upon our distinct market position, drive sustainable value creation, and improve access and care for patients. Our strategic goal is to be America's number one affordable medicines company, and we are well on our way. I'll now turn it over to Chintu.

Thank you, Chiran and good morning everyone. Let me Begin by expressing my deep appreciation, to our amn team, your passion, resiliency and unwavering commitment continues to drive amn forward as a deeply purpose-driven company. This morning. I will provide an update on our strategic priorities, across operations, Innovation, and expanding portfolio, and how these are translating into strong execution and sustained performance in 2025.

Anastasios Konidaris: Each year, we make targeted investments in digitization and automation across our network to improve efficiency and scalability. We also stay focused on our cost structure through various operational excellence programs. These capabilities enable us to launch new complex products, help address drug shortages, and meet the needs of our customers and the patients we serve. Amneal has built one of the largest and most advanced U.S. pharmaceutical manufacturing footprints anchored in New York and New Jersey, with broad capabilities across oral solids, liquids, topicals, transdermals, and complex formulations, making Made in America a core strategic advantage. In the second quarter, we announced our collaboration with Epigenet to start U.S. injectable manufacturing, leveraging their low-field technology capabilities. This partnership strengthens our ability to serve both commercial and government markets with large production capacity while supporting U.S. emergency preparedness and national health security. This expansion extends our leading U.S.

First, in operations, I was Global high-quality manufacturing infrastructure, Remains the key competitive advantage, and we continue to be recognized for its quality, track record and industry-leading. Reliability each year, we make targeted investments in digitization and automation across our Network to improve efficiency and scalability. We also stay focused on our cost structure through various operational excellence programs. These capabilities enable us to launch new complex products, help address

Shortages and meet the needs of our customers and the patient we serve.

Emil has built 1 of the largest and most advanced us. Pharmaceutical manufacturing Footprints anchored in New York, and New Jersey with broad capabilities across berol, solid liquids, opticals Transformers and complex formulations making made in America, a core strategic advantage.

Anastasios Konidaris: pharmaceutical manufacturing footprint and expands our domestic capabilities for future complex products in sterile dosage forms. Turning to innovation, we are very pleased with the continued strong performance of Rytary in the first year of launch. Rytary is uniquely designed to deliver rapid onset and sustained efficacy, giving Parkinson's patients more good on time with fewer daily doses. Our Phase 4 study remains on track, and we expect the real-world data to further reinforce Rytary's clinical value and differentiation. Next, in our specialty business, is Kynmobi, the now approved DHE autoinjector for migraine and cluster headache. This is the first and only autoinjector formulation of this well-established priority. This paves the way for us to develop other drug-device combination products that are clinically relevant for providers and can help patients in other branded therapeutic areas. In GLP-1s, our strategic partnership with Medcera is advancing.

In the second quarter, we announced our collaboration with EP to start us injectable manufacturing leveraging that blowfield field technology capabilities. This partnership. Strengthens our ability to serve both commercial and government markets with large production capacity while supporting us emergency preparedness and National Health security. These expansion extends our leading us pharmaceutical, manufacturing footprint, and expands our domestic capabilities for future complex products, in sterile dosage forms.

Turning to Innovation. We are very pleased with the continued strong performance of cracks salt. In the first year of launch cracks on is uniquely designed to deliver rapid onset and sustain efficacy. Giving Parkinson's patients more, good on time, with fewer daily doses, our phase 4 study remains on track.

We expect this real-world data to further reinforce cracks in clinical value and differentiation.

Next in our specialty business is brachia. The now approved DHE auto injector for migraine and cluster headache.

This is the first and only auto injector formulation of this well established therapy.

This paves the way for us to develop Other Drug device, combination products that are clinically relevant for providers and can help patients in other branded therapeutic areas.

Anastasios Konidaris: We are building two state-of-the-art manufacturing facilities, one for high-volume peptide drug substance production and the other for advanced sterile fill-finish capabilities. Medcera's lead programs are progressing well through development, with impressive efficacy and strong product profiles and timelines that are not too far out, positioning us to participate meaningfully in this high-growth market. This collaboration draws on our core strength in complex pharmaceutical R&D and manufacturing. Through our differentiated integrated business model, we believe we can drive innovation at scale and deliver new, impactful obesity therapies for patients. In our affordable medicine portfolio, we expect to launch 20 to 30 new products each year. We have launched 15 new products so far in 2024. In Q2, we were pleased to receive approval for our generic version of Pred Forte, a complex ophthalmic product.

Is advancing.

We are building 2 state-of-the-art manufacturing facilities, 1 for high value peptide, drug substance production and the other for advanced, sterile field, finish capabilities, Max era's, leap programs are progressing well, through development with impressive efficacy, and strong product profiles, and timelines that are not too far out.

Positioning us to participate meaningfully in these high growth Market. This collaboration draws on our core strengths in complex pharmaceutical R&D and Manufacturing. Through our differentiated integrated business models, we believe we can drive Innovation at scale and deliver new impactful obesity therapies for patients.

Anastasios Konidaris: Among upcoming key launches this year, there is Aristada injection for schizophrenia, a generic version of Restasis for dry eye, and many more. Overall, our affordable medicine pipeline remains deep and robust, capable of producing new products for years. We are very pleased with our continued progress in developing complex products across key categories such as microspheres, liposomals, and 505B2 injectables. We are also making strong progress in inhalation, which will become a new vector of growth beginning next year, with two commercial inhalation product launches expected in 2026. As of Q2, there are 76 ANDA pending approvals, out of which 67% are non-oral solids and 47 products in development, out of which 96% are non-oral solids. We continue to prioritize our R&D portfolio and allocate investment towards higher growth areas like specialty brands, injectables, and biosimilars.

In our affordable medicine portfolio. We expect to launch 20 to 30 new products each year. We have launched 15 new products so far in 2025, in Q2, we were pleased to receive approval for our generic version of press 4 days. A complex of 3 products among upcoming key launches this year there is rest period on injection processor.

A genetic test is for dry eye and many more.

Overall, our affordable medicine pipeline remains deep and robust, capable of producing new products for years.

We are very pleased with our continued progress in developing complex products. Across key categories, such as microspheres, liposomal and firefight B2 injectables. We are also making strong strong progress in inhalation, which will become a new Vector of growth beginning next year with 2 commercial Innovation product launches expected in 2026.

Anastasios Konidaris: In biosimilars, we see an opportunity for Amneal Pharmaceuticals to establish a leadership position in the space. This year, we are filing five biosimilar pipeline candidates with launches targeted for 2026 and 2027. The BLA filings for two Denasumab biosimilars were submitted with gold date in Q4. Next, we look to submit the supplemental BLA for our PEG-filled grafting OBI and autoinjector in Q4, followed by the BLA filing for biosimilar Xolair in Q4. We are pleased that our PEG-filled grafting OBI and autoinjector product, as well as our biosimilar to Xolair, will be made in America, underscoring our commitment to high-quality U.S.-based manufacturing and supply chain reliability. Recently, we shared positive phase three data for biosimilar Xolair, positioning us to be among the first entrants in the $3 billion market. We are focused on advancing these programs and continuously adding new programs to expand our biosimilar portfolio.

As of YouTube, there are 76 and is spending approval out of which 67% are non-oral, solids and 47 products in development out of which 96% are non-oral. Solids, we continue to prioritize, our R&D portfolio and allocate investment towards higher growth areas like specialty Brands, injectables and biosimilars.

In BIO similar, we see an opportunity for Emily to establish a leadership position in the space. This year, we are filing 5 V, similar pipeline, candidates with launches, targeted for 2026, and 2027 the bla filings for 2 Banana bios seniors were submitted with cold days in quarter 4. Next, we look to submit the supplemental,

Dla for our backfield grass, team Obi and auto injector in quarter, 4, followed by the bla filing for B. Similar zelet in quarter 4, we are pleased that our pack figuring Obi and auto injector product, as well as our B, similar to zul will be made in America.

Underscoring our commitment to high quality US based manufacturing and supply chain. Reliability recently, we share positive phase 3 data for Bio similar. Zoe positioning us to be among the first entrance in the 3 billion dollar market.

Anastasios Konidaris: In summary, we have continued our strong operational momentum and execution in 2025. Our strategic focus on innovation, quality, and manufacturing excellence sets the way for sustainable growth and category leadership across our business over time. Thank you, and with that, I will hand it over to Anastasios Konidaris.

We are focused on advancing these programs and continuously adding new programs to expand our bio similar portfolio.

Chintu Patel: Thank you, Chintu, and good morning, everyone. We are very pleased with our second quarter's financial performance as the resiliency of our diversified business model, strong growth in our specialty business, and focus on efficiency delivered revenue growth of 3%, adjusted EBITDA growth of 13%, and adjusted EPS growth of 56%. Furthermore, we reduced net leverage to 3.7 times versus 3.9 times adjusted EBITDA in December 2024 and fully refinanced our debt, which will reduce interest costs substantially and extend maturities to 2032. From a top-line perspective, Q2 was another quarter of growth, with total net revenues up 3%. Our affordable medicines revenue of $433 million grew 1% on top of last year's exceptional growth of 14%. Our current quarter growth was driven by new products, where 2024 and 2025 launches added $33 million.

In summary, we have continued, our strong operational momentum, and execution in 2025, our strategic focus on Innovation quality, and Manufacturing Excellence sets the well for sustainable growth, and category leadership across our business over time. Thank you. And with that, I will hand it over to castles. Thank you for doing good morning everyone. We're very pleased with our second quarter financial performance as the resiliency of our Diversified business model.

Strong growth in our specialty business and focus on efficiency, delivered, Revenue growth of 3%, adjusted with that growth of 13% and adjusted, EPS, growth of 56%.

Furthermore, we reduced net leverage to 3.7 times versus 3.9 times adjusted. Evida in December 2024 and fully refinanced. Our debt, which will reduce interest cost substantially and extend maturities to 2032.

On the top line perspective, Q2 was another quarter of growth with total net revenues up 3%.

Chintu Patel: It is important to note that during the second quarter, our commercial teams built a strong foundation with our clients across a number of new 505B2 products, while our global supply teams completed a few production facilities upgrades. The combination of multiple highly innovative products and enhanced manufacturing supply to meet market demand gives us confidence for even higher revenues in subsequent quarters. Q2 specialty revenue was also very strong at $128 million, as it grew 23% year over year. This growth was driven by our three main branded products, with Ongentys adding $11 million, Rytary adding $9 million up 19%, and Unithroid adding $4 million up 12%. We continue to be very pleased by the market acceptance of Ongentys and expect full-year 2025 revenue in excess of our initial estimate of $15 million.

A current quarter. Growth was driven by new products where 2024 and 2025 launches added 33 million

it is important to note that during the second quarter, a commercial teams, build strong foundation with our clients across a number of new 505 B2 products while our Global Supply teams completed, a few production facilities, upgrades

The combination of multiple highly Innovative products and enhance manufacturing Supply to meet market. Demand gives us confidence for even higher revenues, in subsequent quarters,

Q2 specialty Revenue was also very strong at 128 million as it grew. 23% year-over-year.

Growth was driven by our 3 main branded products with cracks and adding 11 million.

Right Dari. Adding 9 million up. 19%.

And newer products, adding 4 million up, 12%.

We continue to be very pleased by the market acceptance of Correction and expect full year 2025 Revenue in excess of our initial estimate of 15 million.

Chintu Patel: In the second quarter, healthcare revenues of $163 million declined 4%, while gross margin increased by 540 basis points and operating income increased by 44%. As we discussed in the first quarter, we are very pleased by the financial performance of healthcare and the team's focus on higher profitability by maximizing the unique value we provide to the VA and DOD compared to the lower margin distribution channel. Let me now move down the P&L. For Q2, adjusted gross margins were very strong at 45.6%, up 470 basis points year over year. These higher gross margins were driven by favorable product mix in each of the three segments and ongoing operating efficiencies. Notably, Q2 adjusted gross margins of affordable medicines grew 270 basis points to 44.3%.

And the second quarter.

After revenge of 163 million declined 4% while gross margin increased by 540 basis points and operating income increased by 44%.

as we discussed in the first quarter,

We're very pleased by the financial performance of aare and the team's focus on Higher profitability, by maximizing the unique value. We provide to the VA and DOD compared to the lower margin distribution Channel.

Let me now, move down the p&l.

Q2 adjusted gross margins were.

At 45.6%, up 470 basis points year over year.

This high gross margins were driven by favorable product mix in each of the 3 segments and I'm going operating efficiencies

Notedly Q2, adjusted, gross, margins of affordable medicines grew 270 basis points to 44.3%.

Chintu Patel: Our second quarter adjusted EBITDA of $184 million grew 13%, driven by top-line growth, higher gross margins, and higher investments in R&D and sales and marketing to ensure future growth. Finally, we were extremely pleased by the 56% growth in adjusted earnings per share, driven by the higher adjusted EBITDA, favorable foreign exchange, and lower interest expense. Looking at our first half financial performance, our total company revenues grew 4%, our adjusted EBITDA of $354 million grew 12%, and our adjusted EPS of $0.45 is up 50%. We are also very pleased by the increased level of profitability, as adjusted gross margin of 44.3% grew 290 basis points and adjusted EBITDA of 25% grew 180 basis points. Before I conclude with our updated 2025 financial guidance, I will just touch on four important topics. First, we are excited about our multiple growth drivers ensuring robust top-line growth.

Our second quarter adjusted AA of 184 million grew 13% driven by Topline growth, higher gross, margins and higher investments in R&D and sales and marketing to ensure future growth.

Finally, we were extremely pleased by the 56% growth in adjusted earnings per share driven by the higher adjusted iida.

Favor, favorable foreign exchange and lower interest expense.

looking at our first half financial performance, our total company revenues grew 4%

Are adjusted a bit of 354 million, grew 12%, and our adjusted EPS of 45 cents is up 50%.

Or also very pleased by The increased level of profitability as adjusted gross margin, 44.3% grew 290 basis points and adjusted. Evida of 25% grew 180 basis points.

Before I conclude with our updated 2025 Financial guidance, I'll just touch on 4 important topics.

Chintu Patel: These include over 20 new product launches annually, strong uptake of Trexon, the upcoming launch of Bracia for migraine and cluster headaches, multiple new biosimilar launches next year, and large new product opportunities available to the VA and DOD. Second, from a target perspective, and while we do not have full clarity, we have multiple levers to mitigate any potential negative impact. As we have discussed, we have one of the largest U.S. manufacturing footprints in our industry. We have extensive experience with tech transfers. We have no meaningful exposure to Mexico, Canada, China, or Europe, and finally, no exposure to any most favored nation pricing action. Third, from a balancing perspective, we are extremely pleased by the full refinancing we opportunistically completed last week.

First, we're excited about our multiple growth drivers and ensuring robust Topline growth. This include over the 20 new product launches annually.

Strong uptake of cracks on the upcoming launch of brachia for migraine and cluster headaches.

Multiple new biosimilar lenses next year and large new product opportunities available to the VA and DOD.

Second from the darks perspective. And while we don't have full clarity, we have multiple levers to mitigate any potential negative impact.

As we have discussed, we have one of the largest U.S. manufacturing footprints in our industry.

We have extensive experience with tech transfers.

We have no meaningful exposure to Mexico, Canada, China or Europe.

And finally, no exposure to any most, favorable Nation pricing action.

Chintu Patel: In summary, we refinanced $2.7 billion of debt by issuing $2.1 billion in a new seven-year term loan bin and a brand new $600 million seven-year senior secured note. The refinancing was extremely well received and oversubscribed many times over and achieved long-term interest cost reductions of more than $33 million annually and extended maturity to 2032 versus 2028. Fourth point worth mentioning is that because of the new federal tax legislation, we expect about $46 million in cash tax savings, most of which will occur in 2026, improving our cash flow. This benefit is primarily driven by the immediate expensing of R&D and upfront depreciation of assets. With the strength of our first half performance, the multiple levers of growth drivers and solid execution, we are pleased to update our 2025 financial guidance.

Third from the balance sheet, we're extremely pleased by the full. Refinancing, we have opportunistically completed last week.

Finance $2.7 billion of debt by issuing $2.1 billion in a new 7-year term loan and a brand new $600 million 7-year senior secured note.

The refinancing was extremely, well, received and oversubscribed many times over and achieved long-term interest cost reduction of more than 33 million dollars, annually and extended maturity to 2032 versus 2028.

Fourth points worth mentioning is that because of the new federal tax legislation, we expect about 46 million in Casta savings, most of which will occur in 2026, improving our cash flow.

This benefit is primarily driven by the immediate expensing of R&D and upfront depreciation of assets.

Chintu Patel: For revenues, we continue to expect $3 to $3.1 billion. We are increasing adjusted EBITDA by about $15 million in the range of $665 and $695 million. We are increasing our adjusted EPS by about $0.05 between $0.70 and $0.75, and we are also raising our operating cash flow guidance, excluding disputed items, by about $20 million in the range of $300 and $330 million. With that, I will turn the call back to Chirag.

The strength of our first half performance is the multiple levels. Levers of growth drivers and solid, execution were pleased to update our 2025 Financial guidance.

For revenues, we continue to expect 3 to 3.1 billion.

For increasing adjusted ibida. By about 15 million.

In the range of 665 and 685 million.

Or increasing our adjusted EPS by about 5 cents between 70 and 75 cents.

And we're also raising our operating cash flow. Uh, guidance, excluding discrete items by about 20 million

Anastasios Konidaris: Thank you, Anastasios. Q2 results and increased 2025 guidance reflect the continued strength of our diverse business. We are confident in our ability to continue advancing in this new chapter of growth towards our goal of being America's number one affordable medicines company. Let's now open the call for questions and answers.

In the range of 300 and 330 million with that, I'll turn the call back to Shir.

Thank you tosos Q2 results and increase. 2025 guidance, reflects the continued strength of our diverse business. We are confident in our ability to continue advancing. In this new chapter of growth towards our goal of being America's number 1, affordable medicines company. Let's now open the call for a question and answers.

Speaker 5: Thank you. We will now begin our Q&A session. When preparing to ask a question, please ensure your device is unmuted locally. Our first question comes from David Amsellem from Piper Sandler. Your line is now open. Please go ahead.

Thank you.

We will now begin our Q&A session.

When preparing to ask a question, please ensure a device is unmuted locally.

Our first question comes from David and Salem from Piper Sandler.

Your line is now open. Please go ahead.

David Amsellem: Thanks. Just a couple for me. First on Rytary in the overall Parkinson's franchise. As we move through 2025 and into 2026 with the LOE of Rytary, how should we think about when the Parkinson's franchise reaches a trough and when you think you will be in a position to return that business to growth once you have absorbed the full impact of the LOE? Just help us understand that particularly as we move into next year. That is number one. Then number two, on the Maxzeta collaboration, noted that you talked about commercial manufacturing for at cost plus a margin. Just wondering how profitable that is going to be and the extent to which those economics ultimately will expand your overall profitability. Thanks.

Um, thanks just a couple for me, first on, and writer in the overall parking some franchise, as we move through, um, 25 and into 26 with the eloe over Atari. How should we think about when the Parkinson's franchise reaches a trough? And when you think you'll be in a position to return that business, um, to growth? Um, once you've absorbed the full impact of the yellow where you just help us understand that particularly as we move into next year, so that's number 1. And then number 2 on the Mets uh collaboration. Um,

Notice that um you talked about uh commercial manufacturing uh for at Cost Plus a margin, just wondering how profitable that is going to be and the extent to which um that those economics ultimately will expand your overall profitability. Thanks.

Anastasios Konidaris: Hey, David. Good morning. This is Anastasios. Let me take the first one. To directly answer your question in terms of the growth of the business, just from a context perspective, last year, Rytary did about $210 million worth of revenue, and obviously, we had no DHE. My gut feel is this year, as you know, even though the LOE of Rytary was on July 31st, there has been no approval for a generic Rytary. That is going to help us this year, and I think it is also going to help us in the short term next year whenever generics become available. Our gut feel is this year with probably DHE doing, let us say, $55 million or so. Maybe Rytary does about $150. So essentially, the combined portfolio is essentially kind of flat to last year from a revenue perspective.

Uh hey David. Good morning this is tasos. So let me take the first 1

Uh, so with, um, just it directly answer your question in terms of the trust of the business, just from a context perspective. So last year I tari did about 210 million dollars, worth of Revenue. And obviously we had no correction.

My gut feel is this year, as you know, even though the LOE of rytary was on July 31st, there has been no approval for a generic, uh, radar. So, that's gonna

Helping us this year. And it's also I think it's going to help us in the in the short term uh next year whenever um, generics become available.

Our gut feel is this year would probably correction doing let's say, 55 million dollars or so.

Anastasios Konidaris: EBITDA is a bit of a drag this year, which we are obviously able to overcome because of the growth of the rest of the business and just reflects the investments we need to make grow DHE. The trough we believe comes next year from a revenue perspective, because next year, Rytary probably will have obviously more of a generic competition than this year. But at the same time, DHE is growing very, very rapidly. So I think the trough comes next year from a revenue perspective, okay? But I believe from an EBITDA perspective, trough is probably I do not expect much of dilution than this year from an EBITDA perspective because this year we already absorbed a substantial headwind to EBITDA because of the investments of DHE.

Investments. We need to make um to grow correctly.

Anastasios Konidaris: But nevertheless, even if there is a bit of a headwind next year from an EBITDA perspective as well, we will feel confident we will be able to overcome this as the rest of the business will more than offset that. So at the end of the day, trough comes next year. Highly confident we will be overcoming it because we are trying to drive the total business to continue to grow top line and bottom line. Hopefully, that works for you. Let me turn to Chirag on the term.

The trough, we believe comes next year, right? From a revenue perspective. Because, like next year, uh, rytary probably will have, you know, obviously more of a generic competition that this year, but at the same time, Kraken is growing very, very rapidly. So I think the trough comes next year from a revenue perspective. Okay. But I believe from a from a NBA perspective, trophies probably, I don't expect much of delusions and this year, from a Navy that perspective because this year, we already observed the substantial headwind to Evie it up because of the Investments of Correction. But nevertheless, even if there is a bit of a headwind. Next year, from Aida perspective as well. We feel confident, we will be able to overcome this as the rest of the business will more than offset that. So at the end of the day, Prof comes next year. Highly confident. We will be overcoming it because because, you know, we're trying to drive

To Total business to continue to grow Top Line and bottom line.

Chirag Patel: Yeah. So, David, good morning. Maxzeta collaboration is moving forward very awesomely. We have so many scientists, engineers that have worked, my brother, everybody, and we worked with Clive and with the team over there. Great progress, and we could not be even more happier than this about our partnership. It is very properly structured as we have taken a lot of risk upfront building the sites. So we would expect more margins than typical CMO or CDMO because we have taken upfront risk. So we are not sizing up the margins at this point, but they are higher than obviously the generics margins, much higher. The second point is international markets, which we control the marketing. We do not know yet exactly what price it would be sold at, but to give you the reference, we launched Manzaro in India at $160 a month.

So hopefully that works for you. Let me turn to you right on the Terra. Yeah, so David good morning mister collaborations. Uh, moving forward, very awesome. We have

So many scientists engineers that had worked. Uh, my brother, everybody's, uh, and we worked with the client with Team over there, uh, great progress. And we could not be even more happier than, uh, this about our partnership. It is very properly structured. As we have taken, uh, a lot of risk up front building the sites. Uh, so we would expect, uh, more margins, like typical CMOS cdmo because we have taken up front risk. So those are we are not sizing up the margins at this point, but there are higher than obviously the generics margins much higher and uh,

Second point is international markets, which we control the marketing.

We do not know yet exactly what price it would be sold at but give you the reference.

uh,

launch monzo in India at $160 a month.

Chirag Patel: So of course, there will be some Ozempic generics competition, and we hear they could be launching at $60, $80 a month for monthly treatment. So you can see it's a substantial opportunity for us, and we have 20, right, so 20 countries. India would be setting the prices for most of the countries, and I don't think we would be lower than India's prices in any of those countries. A significant number of patients that could be on this therapy, it's the India number at this price, somewhere between $60 to $160. The product is in shortage already. It's some 50 million patients, five zero. So these are large numbers of patients. Volume will drive margins, and higher penetration we could do would be driving significant revenue. We won't be sizing all this starting from the beginning of 2026.

So if of course, there will be a genetic competition and we hear that it could be launching at 60, 800 dollars a month um for a monthly treatment. So you can see it's a substantial opportunity for us and we have 20 rights to 20 countries and India would be setting the prices for most of the countries. Uh and I don't think we would be lower than India's prices in any of those countries.

Chirag Patel: I would say these are very significant opportunities for us for supplying Maxzeta as well as for our own international marketing. So that's for Maxzeta.

Uh and significant number of patient. Uh, that could be on this therapy. It's uh the the India number at this price somewhere between 60 to 160. Uh I was there, the product is in shortage already uh is some 50 million patient 50. So these are large numbers of patient. Volume will drive uh margins and higher higher penetration, we could do would be thriving. Uh significant Revenue. We will be sizing all these starting from uh, beginning of 2026. I would say these are very significant opportunities for us, uh, for supplying meds Sarah, as well as for our own International marketing. Um,

so, that's

For night, set up.

Speaker 8: Helpful. Thank you.

Couple, thank you.

Speaker 5: Thank you. Our next question comes from Elisabeth Sielewski from J.P. Securities. Your line is now open. Please go ahead.

Thank you. Our next question. Comes from lack salowski from duress Securities. Your line is now open. Please go ahead.

Leszek Sulewski: Good morning. Thank you for taking our questions. First, on the Parkinson's franchise, maybe just provide a latest status of the Rytary generic launches. Also, can you maybe provide some additional commentary on where you stand with the reimbursement? Separately, what is the update on the regulatory approval process across some of the other partners internationally that you have disclosed before? Maybe provide any additional timelines that you would expect on your international or your launch in India on the product. Maybe how do you think about the size of that opportunity? Separately, maybe just kind of a longer view as you are capturing some of the uptake from these partnerships, including Maxzeta and others, and lean more into innovative products. How are you thinking about the overall gross margin profile for the enterprise kind of moving into 2027 and beyond? Thank you.

Uh, good morning, thank you for taking our questions. Um, first on the Parkinson's franchise, maybe just provide a latest status of the right hairy generic um, launches and also can you maybe provide some additional commentary on where you stand with the reimbursement and uh, separately. Uh, what's the update on the regulatory approval process across some of the

And Beyond. Thank you.

Anastasios Konidaris: Yeah. So let me take, I will take the Rytary generic question, then I will pass it over to Jill, who heads up commercial operations, commercial business for specialty. Then I will turn it over to Chirag and Chintu for some of the partnerships, and I will tackle the margin profile. In terms of generics, so far, Teva has a 180-day exclusivity on the generic Rytary. They currently have not been approved. Frankly, I know as much as you do on when that may happen, right? That is as much as I can tell you. Our view is it is a sizable opportunity. We expected in our planning that generics were going to become available August 1st. Obviously, this kind of what I will call short-term delay kind of helps us from a financial perspective. It allows us to reinvest in the business. It allows us to increase our guidance.

Um yeah. So let let me take, I'll take the um right. Uh generic question. Then I'll pass it over um to uh to Joe who who heads up commercial operations Commercial Business for specialty. Then I'll turn it over to to Shira and Chin to for some of the the Partnerships. Um and I'll I'll tackle the margin profile. Um so in terms of generic so um

Anastasios Konidaris: At some point in time, there will be generics maybe later on this year, sometime next year, and we will be in a great position to overcome any headwind that may come out of that. I think that is the answer to your first question. Let me turn it over to Jill. Give me an update on the reimbursement on Trexon.

So so far so, you know, Deva um, has 180 days exclusivity on the generic write diary they currently have not been approved. And frankly, I know as much as you do on on when that may happen, right? So that, that that's that's that's as much as I can. And as much as I can tell you, um, uh and so forth, you know, our our video is, it's a sizable. It's a sizeable opportunity. Uh, you know, we expect it in our planning, the generics we're going to become available in progress. First, obviously this, uh, kind of what I will call short-term delay. Kind of helps us from a financial perspective. It allows us to reinvest in the business, it allows us to increase our guidance, but at some point in time, there will be generics maybe later on this year, sometime next year and we'll be in a great position to

Jill Renda: Yeah. Thanks, Anastasios Konidaris. Hi, Leszek Sulewski. Thanks for the question. We have been really pleased with coverage so far with Trexon in the market. Actually, it is above our expectations. We were anticipating around 50% coverage or so for the year. We have garnered now over 60% commercial coverage, which includes some of the biggest payers in the market: United, CVS, VA, DOD. So really pleased with coverage. And we anticipate that to continue because we are in good dialogue with the payers related to some of the Part D plans. So we are looking to land those. Our goal was always around 70% coverage. We are well on our way there. The feedback from the market continues to be really strong from our key prescribers.

Jill Renda: So we are anticipating that the growth we are seeing is going to continue, and it is partly because of that great access that we have created so far.

Overcome, um, any any headwind that may come out of that? So I think that's the answer to your first question. Let me turn it over to Joe. Give me an update on the reimbursement. Um, on our correction. Yeah thanks, yeah, thanks for the question. Uh, we've been really pleased with coverage so far with with cracks on the market actually it's above our expectations, we were anticipating around 50% coverage or so far this year uh, regarded now over 60% commercial coverage, which includes some of the biggest payers in the market United, CVS, VA DOD, uh, so really pleased with coverage and we anticipate that to continue because we're in good dialogue with the payers related to some of the part D plans. So we're looking to land those. So, our goal was always around 70% coverage. Uh, we're well on our way there and uh, the feedback for the market continues to be really strong from our key prescribers. So we're anticipating that the growth we're seeing is uh is

Anastasios Konidaris: Let me take a crack also at some of the questions more about regulatory progress on some of the ex-U.S. business or the margin profile with those partnerships. What we have said, right, is that over the course of time, 99.9% of our revenue is U.S.-based. That leaves a lot of white space, call it ex-U.S. We have made the strategic choice that the best way for us from a capital allocation perspective is instead of trying to build the infrastructures in those markets, which has a very long-term payback period, to develop the partnership model for all markets except India. Obviously, there is a lot of our own heritage in India. We have 6,000 employees already over there. More importantly, if you think about India, the standard of living is growing substantially. The size of the pharmaceutical market there is expected to grow dramatically.

Going to continue and it's partly because of that great access to Leaf created so far.

So let me let me take a crack. Also at some of the question more about uh regulatory progress on on some of the xus business or uh kind of the margin profile with those Partnerships.

So what what we have said, right is that internal over the course of time of 99.9 of our revenue is us-based, right? So that leaves a lot of white space, call it xus,

So we have made the Strategic choice that the best way for us from a capital allocation perspective is, instead of trying to build the infrastructures in those markets, right? Which is has a very long-term pay bacterial uh to develop the partnership model.

Anastasios Konidaris: A combination of our heritage, a combination of our existing infrastructure in India, a relevant product portfolio, and a very large market, it only makes sense to extend for us to launch our own Amneal brand in that market. The uptake is growing very nicely. We have a few hundred people. We have established a commercial team based in Mumbai. We have a few hundred commercial teams who are building it out. Early days of the product portfolio launching there. That is going to build over the course of time. You should not expect anything drastic over the next couple of years, but that is going to build over the course of time. In the rest of the markets, we out-license Trexon in Europe. That regulatory process is in process. That is going to come over the next couple of years with product approval and slowly building that revenue portfolio.

Uh, for all markets except India and obviously there's a lot of our own Heritage in India. We have 6,000 employees already over there. And more importantly, if you think about India, the standard, the standard of living is is growing substantially. The size of the pharmaceutical Market. There is supposed to grow, is expected to grow dramatically. So, combination of our heritage combination of our existing infrastructure in India, a relevant product portfolio and a very large Market. It's only made sense to extend to kind of for us to launch our own Emil brand in those in that market. Uh, and and and that the uptake is, is growing very nicely. We have a few hundred people. We do have established, the commercial team based in Mumbai. Our few hundred commercial teams were building.

Out um, early days of the product portfolio launching there and that's going to build over the course of time. You shouldn't expect anything drastic over the next couple of years. But that's going to build over the course of time.

Anastasios Konidaris: That is a little bit, I think those are the two main drivers of growth of our international business over the next few years. From a margin perspective, we are not in the business of diluting margins. What you should expect from us is to continue to drive gross margin increases steadily over the course of time. Our adjusted EBITDA to revenue has been hovering at about 22.5%. You should expect this over the course of time to increase. We are not doing anything dramatic because we want to continue to invest in the business because we see a tremendous amount of growth, whether it is in the injectables, biosimilars, international, I just mentioned it. We are not in the business of diluting margins or diluting our cash flow. With that, let me turn it over to Chintu or Chirag to see if they have anything else to add.

Kind of what I will call drivers, of course of our international business over the next over the next few years.

From uh, once I want from a, from a margin perspective, listen, we are not in the business of diluting margin. So we usually expect from us is kind of continue to drive gross margin increases steadily over the course of time.

Uh, our adjusted eida to revenue, it's been hovering at about 22 and a half percent. You should expect this over the course of time to increase and we're not doing anything to do anything. Dramatic, because we want to continue to invest in the business because we see tremendous amount of growth whether or not it's in the injectables biosimilars international. I just mentioned it, but we're not in the business of diluting margins or are diluting our cash flow.

Chirag Patel: Thank you, Darto. I just wanted to add on an international partnership. First of all, we are very happy and pleased with Crexent and how all the testimony and competition and our partners in Europe and Latin are very pleased, and we are very excited. We hope to launch these products in Europe by late 2026 and in India late 2026 to early 2027. Our regulatory applications are moving well, and we are excited. Plus, we have a diversified manufacturing footprint and a cost advantage. We are also qualifying our India side for Crexent to improve our margins. Just wanted to add that.

So with that, let me turn it over to Chanty or she asked to see if they have anything else to add. Well, thank you D. So I just wanted to add on International partnership. First of all, we are very happy and pleased with tracks on and how the all the testimonial information for patient and our partners in Europe and Latin are very pleased, and we are very excited. And we hope to uh, launched these products in Europe, by late 2026, and India late 26, to early 2027. So,

Applications are moving well and we are excited plus to be have a diversified manufacturing footprint and a cost Advantage. We are also qualifying our India site for cracks on to improve our margins. Just wanted to add that

Leszek Sulewski: Very helpful. Thank you.

very helpful. Thank you.

Speaker 5: Thank you. Our next question comes from Chris Schott from JPMorgan. Your line is now open. Please go ahead.

Our next question comes from Chris Scott from JP Morgan. Your line is now open. Please go ahead.

Katarina: Thank you so much. This is Katarina on for Chris Schott. First question is just around guidance. I think the revenue range does imply a bit of a step up as we kind of think about revenues in the second half versus the first half of the year. Can you maybe elaborate what are the main drivers of this? I am assuming some of this is the timing of new launches and perhaps the delay in Rytary, but just anything else to kind of keep in mind. Second question is just around tariffs. Just latest thoughts on what these could mean for the industry and Amneal Pharmaceuticals, and I think specifically what are you hearing out of Washington on how generic products and API could be treated as we think about the 150% or 250% tariffs that are kind of being thrown around? Thank you.

Uh, thank you so much. This is Katarina on for Chris. Um, so first question is around guidance. I think the revenue range doesn't apply a bit of a step up as we kind of think about revenues and the second half versus the first half of the year. Can you maybe elaborate what are the main drivers of this? I'm assuming some of this is the timing of your launches and perhaps the delay in rytary, but just anything else to kind of keep in mind. Uh, and second question is just around tariffs display the spots on, you know what these convenience for the industry and the meal. And I think specifically, what are you hearing out of Washington on how generic products and API could be treated as we think about, you know, the 150 or 250% tariffs that are kind of being thrown around? Thank you.

Anastasios Konidaris: Hey, Katarina. I can take the first one. We expect a stronger second half from a revenue perspective than the first half. As you said, there is nothing fundamentally different other than the typical, what I would call cadence of new product introductions. Products that we launched late in 2024, early 2025, they keep building momentum over the course of time. That is number one. Number two is even though the vast majority of the products we were expecting to launch in 2025 have already launched, there are just a few more that are supposed to be coming in Q3 and Q4. So those will add to the revenue growth. The third point is really we are looking at, as I mentioned in my script, in Q1 and Q2, we completed a number of facility upgrades that kind of prevented us from meeting market demand primarily on our injectable portfolio.

Hey, hey, can I can take the first 1? We expect a stronger second half from a revenue perspective than the first half. And as you said there is there is nothing fundamentally different other than the typical what I would call Cape is a new product introduction. So products that we launched late in 2024 early 2025 they keep building momentum over the course of time that's number 1. Number 2 is even those vast majority. The majority of the products we were expecting to launch in 2025 have already launched, but they were just a few more that are supposed to be coming in Q3 and Q4. So those will allow to to the revenue growth. Um, and the third point is really, we're looking at, as I mentioned, in my script, in queue in q1, and Q2, we completed the number of facility upgrades that kind of

Anastasios Konidaris: Now with those essentially behind us, it just frees up capacity and just improves our global supply ability to meet market demand. So all of those things will play into the second half of the year to have kind of stronger revenue performance than the first half. Obviously, we are looking for growth from a top-line perspective kind of going into 2026 and 2027 with a strong tailwind behind us. I will turn it over to Chirag Patel to maybe tell us a little bit about all their adventures coming out of Washington, D.C.

Prevented us from meeting market demand primarily on our injectable portfolio. Now, with those essentially behind us it's just a freeze up, uh, capacity just improves our Global Supply ability to meet market demand. So all of those things will will play into the second half of the year to have kind of a stronger Revenue performance than the than the first half. Um, and

Chirag Patel: Great. That's the hardest job to do. So we've been meeting and giving our perspective to the administration, which is rightfully focused on two things. What is driving these pharma investigations? One is national security. So heavily over-reliance on antibiotics would be like 95% of key starting material coming from China. Many we hardly make anything in the United States. Even finished goods, it's less than 2%. So if you take each of these critical categories, we have virtually no manufacturing in the United States. The second thing is socioeconomics, obviously, that it creates American jobs and more factories, more plants in the United States. With that, we've been not negotiating, but we've been putting new solutions because if you put a 150%, as you said, or 200% tariff, it's going to be chaotic because nobody knows how long the tariffs would stay.

And antibiotics will be like 95% of keep starting material coming from China. Uh, and many, we we hardly make anything in the United States. Even finished goods. It's less than 2%. So if you take each of these critical categories, we have, uh, virtually no Manufacturing in the United States. Uh, second thing is socioeconomics, obviously that it creates American jobs and uh uh, more uh, more factories, more plants in the United States.

So with that, we

When?

Negotiating, but we will.

Chirag Patel: If there are such large tariffs, obviously, the pricing would have to go up to our customers because we have to keep supplying the products and we have to keep making money. This is not us alone. It's all the companies. We are least impacted because almost two-thirds of our manufacturing values are in the United States. They could create shortages as well. It may not be the solution what administration is trying to do, which we fully support, is for the national security to bring the production of critical products in the United States from the key starting material API to finished goods by creating a demand for American-made products because it will be obviously expensive products to make in America compared to coming out of China or in China and India. With all that, it's still unknown. We'll see what happens. It's still under investigation.

Putting new Solutions because if you put a 150% as you said or 200% tariffs, it's going to be chaotic because nobody knows how long the tariffs would stay. So if there are such a large tariffs, obviously the pricing would have to go up to our customers because we have to keep supplying the products and we are to keep making money and this is not a salon, it's all the companies we are, at least impacted because uh they're almost 2/3 of of manufacturing values in the United States. Uh,

And but they could create shortages as well. Uh I may not be the solution. Word Administration is trying to do which we fully support is for the National Security.

Bring the product production of critical products in the United States from the key starting material API to finish Goods.

By creating a demand for American-made products because it will be obviously expensive, uh, products to make in America compared to coming out of China or China and India. So,

Chirag Patel: As of now, pharma is exempted from all tariffs. We'll stay tuned.

With all that, it's still unknown; we'll see what happens. It's, uh, still under investigation as of now. Former is exempted from all types of will.

Uh, will stay tuned.

Katarina: Thank you so much. I appreciate all the color.

Thank you so much. I appreciate all the call.

Leszek Sulewski: Thank you, Katarina. Next question.

Thank you. Karina. Next question.

Speaker 5: Our next question is from Matt De La Torre from Goldman Sachs. Your line is now open. Please go ahead.

Our next question is from Matt delatore from Goldman Sachs, your line is now open. Please go ahead.

Matt De La Torre: Hey, guys. Good morning, and thanks for the question, and congrats on the continued progress. Maybe first, just to follow up on the prior question on the revenue guide, should we expect the generics and distribution segments to inflect or catch up in the second half? Second question, opposed to recent debt refinancing, what are your latest thoughts on a potential vertical integration of your biosimilars business in terms of timing or likelihood? Then maybe more broadly, how does this increased flexibility that you now have impact your broader capital allocation strategy? Thank you.

Hey guys. Good morning, and thanks for the question, and congrats on that continued progress. Um, maybe first, just to follow up on the prior, question, on the revenue guide, should we expect the generic and distribution segments to an inflector or catch up in the second half?

And then second question, um, post the recent debt refinancing, what what are your latest thoughts on the potential vertical, integration of your biosimilars business in terms of of timing or um likelihood. And then maybe more broadly. How does this increase flexibility that you now have impact your your broader Capital allocation strategy. Thank you.

Anastasios Konidaris: Hey, Matt. This is Anastasios Konidaris. Good morning. First on that, can we expect growth in the second half, substantial more growth in the second half? There is, and that's really driven by what I call stability on the distribution channel. That's point number one. Number two is we expect our government business to accelerate the growth that we have already seen this year because there is a number of large product launches. I don't want to talk specifics. There is at least one or two large product opportunities that will become available in Q3, and that will be in a position to capitalize on that opportunity. That's kind of number one. From a refinancing perspective, before I turn it over to Chirag Patel to talk about, from a refinancing perspective, as I mentioned before, that was just incredibly successful, substantially reduces our interest expense.

Hey, Matt, this is toss. Good morning. Um, first first onatah, we expect growth in the second half substantial more growth in the server. Second half there is and that's really driven by uh, what I call, you know, stability on the distribution channel. So at this at this point in time Point number 1 and number 2 is we expect our government business to accelerate the growth that we have already seen this year because there is another number of large product plans is, I don't want to be talk, specifics. There is at least 1 or 2, large product opportunities that will become available in Q3 and Africa will be in in a position, um, to capitalize on that opportunity. That's kind of number 1. Um,

From a, uh, uh, refinancing perspective before I, before I turn it over to, to shirat, to talk about. Um,

Anastasios Konidaris: Depending on what month we use, it decreases our interest expense between 16% and 20% per year. So that's a dramatic improvement. Number one, it extends maturities by four years to 2032. We don't expect this to change our capital allocation policy. Over the course of time, what we have said is we want to make sure that we fund our business appropriately and capitalize on the opportunities that we have, number one. Also deleveraging over the course of time is really important to us. You know that doesn't need to be linear, right? Every single quarter, every single year. But over the course of time, I think we've done a really good job, essentially cutting leverage by half in the last four or five years. So that's kind of our area of focus. Chirag, anything else?

Chirag Patel: Yeah. Thank you, Darto. Your second question might be on when do we look to integrate. First of all, biosimilars, the entire market, it's a race right now. How fast we can execute. FDA has been very cooperative along with MHRA, EMA, the entire world, obviously, for obvious reasons. Tremendous cost savings, but most importantly, it creates more access. More patients. We have seen 2.5 times more volume because of more access, because of lower prices. How many new patients are getting this product? Total support from all of the regulatory agencies, government agencies. I know we had a bad start with Humira as a market, but now there are 100 biologics. Only 20 are being worked on. 80 are not being worked on. Our goal is we have done this so well with complex generics products, and we have invested so much in this. We could do this.

Up in the last 4 or 5 years. So that's kind of our area of focus. Um yeah sure. Anything else? Yeah I think it does. So in your second question met on.

Uh, how when do we look to integrate? So, first of all bio similar is the entire Market. It's a race right now, we have passed, we can execute. Uh, FDA has been very Cooperative along with, mhra EMA, the entire world, obviously, for obvious reasons, tremendous cost savings, and, but most importantly, it creates more access

Chirag Patel: We could have a pipeline of 30 products, 35. We can keep going and make a lot of products in the United States and India and have this combination, which allows us a global supply and global cost position and much faster execution on a number of products. We look to, since it's a race, we look to do it as soon as possible. We will be very disciplined and obviously do the deal, which does not blow any of the we have worked hard to get our debt to EBITDA ratio down. We would like to maintain or have some flexibility there and then set up a deal which we can afford and provides tremendous growth to Amneal Pharmaceuticals going forward. We see this as a great business for the next 10 years.

More patient we have seen 2 and half times more uh volume uh because of more access because of lower prices. So how many new patients are getting these products? So total support from all of the regulatory agency government agencies? I know we had a, uh, the back start with you mirror as a market, but it, it now, there are 100, biological only 20 are being worked on. 80 are not being worked on. So our goal is we have done this so well with complex genetics products and we have invested so much in this, we could do this, we could have 5 line of 30 products. 35, we can keep going and and make a lot of products in the United States and India, uh, and and have this combination, which allows us a Global Supply in global

Cost position and much faster execution uh on number of products. So we look to uh since it's a race we look to do it as soon as possible.

But we'll be very disciplined and obviously do the deal, uh, which doesn't blow any of the, the we have worked hard to get our debt to Viktor ratio down. So we would like to maintain or have some flexibility there and then, uh, uh, set up a deal which we can, uh, we can afford and, uh, uh, to my it provides tremendous growth tools and

Going forward. We see this as a great business for next 10 years.

Matt De La Torre: Great. Thank you both.

Great, thank you both.

Speaker 5: Thank you.

Chirag Patel: Thanks, Matt.

Speaker 5: This concludes our Q&A session. So, I will hand back to Chirag for closing remarks.

Thank.

This concludes our Q&A session, so I'll hand back to Shrek for closing remarks.

Anastasios Konidaris: Oh, thank you very much, everybody. Have a great, great day today. Thank you.

Everybody have a great.

Uh, great day today. Thank you.

Chirag Patel: Thanks, everyone.

Thank you. Thanks everyone.

Speaker 5: Thank you. This concludes today's call. Thank you for joining. You may now disconnect your lines.

Thank you. This concludes today's call, thank you for joining. You may now. Disconnect your lines.

Q2 2025 Amneal Pharmaceuticals Inc Earnings Call

Demo

Amneal Pharmaceuticals

Earnings

Q2 2025 Amneal Pharmaceuticals Inc Earnings Call

AMRX

Tuesday, August 5th, 2025 at 12:30 PM

Transcript

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