Welcome to the Apotex first quarter fiscal 2027 earnings conference call. At this time, all lines are in listen-only mode. Following the presentation, we will conduct a question and answer session. If at any time during this call you require immediate assistance, please press zero for the operator. Please note this event is being recorded. I would now like to turn the conference over to Kevin Mannix, Investor Relations. Please go ahead.
Thank you, operator, and good morning, everyone. Our press release for the company's first quarter financial results and business update became available at 6:00 A.M. Eastern Time this morning and can be found on the investor and news section of our website and SEDAR+. Before we start, we would like to remind you that all amounts discussed on this call are denominated in CAD unless otherwise indicated. Please note that the statements made during this call may include forward-looking statements and future-oriented financial information regarding Apotex and its business. These statements are made as of the date hereof, and Apotex assumes no obligation to update or revise them except as required by applicable securities laws. These statements are based on certain assumptions and involve significant risks and uncertainties and are not a guarantee of future performance or results.
Please refer to risk factors in the forward-looking information sections of the company's public filings, which include, without limitation, Apotex's MD&A, its earnings press release issued today, and its IPO prospectus for additional information. During this call, we will reference certain non-IFRS financial measures. Please see our earnings press release and MD&A for a description of these measures and reconciliations to the most directly comparable IFRS measures. On today's call, we are joined by Jeff Watson, Apotex's President and Chief Executive Officer, and Brian McClelland, Chief Financial Officer. Also joining us for the Q&A portion of today's call are Christine Bader, President of Apotex USA and LATAM, and Martin Arès, President of Apotex Canada and Rest of World. Jeff will spend the next few minutes providing you with key highlights from the quarter and a progress update on our strategic initiatives.
Brian will then walk you through the financial performance and outlook for the business, and then we will open the call for Q&A. With that, I will hand the call over to our CEO, Jeff Watson. Jeff.
Thank you, Kevin, and good morning, everyone. Thank you all for participating in our call today. Before turning to the highlights, I'd like to frame the quarter through the lens of our growth strategy. Our Journey of Health strategy is our roadmap for sustainable growth and long-term value creation. It reflects clear choices about where we play and how we win. We are focused on the Americas, anchored by our leadership position in Canada, expanding selectively into higher value platforms, including specialty generics, biosimilars, and branded medicines. We leverage the strengths that have defined Apotex for decades: strong commercial execution, a deep pipeline of more than 480 planned launches over the next five years, and a manufacturing network built to deliver reliable supply at scale. Together, we believe these capabilities position us to drive growth, expand margins, and allocate capital in a disciplined manner.
We delivered a solid start to fiscal 2027 by remaining focused on what matters most, disciplined execution, prudent capital allocation, and long-term value creation. Across the business, we're continuing to see the benefits of a more diversified portfolio, strong launch e xecution, productivity initiatives that are delivering results, and investments that are expected to strengthen our future growth profile. As I walk through the next several slides, you'll see how those priorities translated into operational and financial performance during the quarter before Brian reviews the results in greater detail. Our first quarter as a public company reflects continued execution against our Journey of Health strategy. During the quarter, we strengthened the business in a number of important ways.
We completed our upsized IPO, reduced our debt by paying down our previously outstanding Pari Passu term loan in the amount of CAD 800 million, launched several first-to-market products, completed the Cumberland portfolio expansion, and continued to execute productivity initiatives targeting more than CAD 100 million of savings in fiscal 2027. We also continued to make good progress at our Richmond Hill facility, advancing remediation activities and preparing our new sterile manufacturing line for qualification. Although we cannot comment on the exact timing of an FDA inspection, based on the progress achieved to date, we currently expect to be ready for FDA re-inspection by the end of calendar year. As previously disclosed, we made a commercial decision to halt production of U.S.-bound ophthalmic products from our OPTHA 2 line as we focused on efforts on qualifying our state-of-the-art OPTHA 3 line.
We expect to begin production for the U.S. generic ophthalmology market upon successful re-inspection by the FDA. We've also been closely monitoring recent comments from the U.S. administration regarding potential tariffs on imported generic pharmaceutical products. While there remains uncertainty regarding the scope, timing, and ultimate outcome of any such measures, Apotex has a long history serving the U.S. market and benefits from a significant North American manufacturing footprint with the majority of our U.S.-bound products produced in Canada. We remain engaged directly and through industry associations with the U.S. administration on how our footprint can be leveraged to benefit the North American onshoring initiative that we share with both the U.S. and Canadian governments. As we recently announced, we entered into a manufacturing partnership with Halo Pharmaceutical, whereby we agreed to fund a sterile injectable line of which we will get committed volume capacity.
These are partnerships that we are continuing to evaluate, and based on our targeted approach to portfolio execution, we will consider additional opportunities that are specific to the U.S. market. Overall, we continue to believe that supply chain reliability, patient access, and pharmaceutical security will remain important considerations as these discussions evolve. We delivered a solid financial performance, which was slightly above our expectations. Excluding the impact of generic Revlimid or VLLP in the prior year, revenue grew approximately 2%, supported by strong growth in Canada and contributions from new product launches. We also closed the quarter with margins in line with our full-year expectations. Our pipeline execution remains on track, with continued momentum across key first-to-market opportunities and an in-year launch revenue expected to exceed 10% of total revenue. Looking ahead, we remain focused on execution.
Our launch momentum is in line with our expectations, and we are introducing fiscal 2027 guidance, including upper mid-single-digit revenue growth, excluding the impact of VLLP, and an adjusted EBITDA margin of approximately 30%. Overall, we are pleased with the start to the year and remain focused on executing our Journey of Health strategy. Turning to slide six, our revenue mix reflects both the benefits of a diversified business model and the impact of product-specific dynamics between periods. Canada represented 49% of revenue in the quarter and delivered strong growth of 11%, supported by recent launch activity and increasing semaglutide demand. The U.S. represented 43% of revenue, while our international business continued to provide geographic diversification. As communicated earlier, from a business line perspective, year-over-year mix was influenced by the absence of contributions from the first-to-file launch of nilotinib that benefited the prior year periods.
We view this as launch calendar timing and have a similar launch plan in the third quarter of this year. More importantly, recent product launches contributed meaningfully to growth during the quarter, reflecting strong execution of our launch strategy and our continued focus on first-to-market and differentiated opportunities in both Canada and the United States. Overall, we believe the quarter highlights the strength, balance, and resilience of the Apotex portfolio and supports our belief in long-term growth opportunities across the business. Turning to slide seven, this quarter provides a good example of how we're executing against our pipeline and positioning the business for long-term growth. As we discussed during the IPO process, we are targeting more than 480 product launches over the next five years.
While the size of the pipeline is important, our focus remains on pursuing opportunities where we believe we have meaningful competitive advantages and can create sustainable value. During the quarter, we continued to make good progress on semaglutide, maintaining a leading position as the current sole supplier of generic Ozempic in Canada and securing first-to-market approval for generic Wegovy. In the U.S., we also launched sitagliptin and sitagliptin metformin under shared exclusivity. Last month, we expanded our U.S. hospital portfolio to the launch of INFUVITE vitamins. Together, these milestones reflect the strength of our development, regulatory, legal, and commercial capabilities, as well as our continued focus on differentiated and first-to-market opportunities. Overall, we remain confident in the depth of our pipeline and the contribution of it to our growth over time.
Turning to slide eight, the Cumberland portfolio expansion transaction represents an important step in the continued evolution of our U.S. business. As we have discussed previously, our strategy is not simply about adding products. It is about building a more diversified portfolio with a greater presence in higher-value markets where we can leverage our commercial and operational capabilities. The transaction adds a portfolio of established branded medicines across hospital, specialty, and institutional channels, while also bringing dedicated commercial infrastructure that strengthens our ability to compete in these markets over the long term. Importantly, this expands our presence in therapeutic areas such as acute care, oncology, infectious disease, and gastroenterology, while diversifying our revenue base within the United States. We view the Cumberland portfolio as a strong strategic fit that supports our Journey of Health strategy and reinforces our commitment to building a more diversified and resilient business.
When viewed alongside our launch execution, pipeline progress, and financial performance in the quarter, the Cumberland portfolio expansion transaction demonstrates the disciplined approach we are taking to position Apotex for long-term growth. With that, I will turn the call over to Brian to review our first quarter financial results and fiscal 2027 outlook in more detail.
Thank you, Jeff, and good morning, everyone. Q1 set the right tone for fiscal 2027 with the results slightly above expectations and a solid foundation for the balance of the year. As a reminder, our year-over-year performance is presented excluding the contributions of the VLLP in fiscal 2026 across a number of key financial metrics to provide a clearer view of the underlying business. The VLLP agreement expired in fiscal 2026, with the bulk of the final sales under this agreement recorded in the first quarter of fiscal 2026 and amounting to CAD 308 million. Revenue was CAD 848 million, up approximately 2% year-over-year on an ex VLLP basis, supported by strong performance from new launches and continued execution on our existing portfolio. Gross profit in the quarter was CAD 421 million, a nominal decline versus prior year, with gross margin of almost 50%.
The year-over-year decline ex VLLP primarily reflects the prior year contribution from the exclusive launch of naloxone in the U.S., but was essentially offset by strong new launch performance and savings from our productivity initiatives. Adjusted EBITDA was CAD 259 million, essentially in line with the prior year, and adjusted EBITDA margin was approximately 31%. We reported a net loss of CAD 38 million, primarily reflecting share-based compensation accounting adjustments triggered by the IPO and an unfavorable foreign exchange impact on translation of our U.S. debt. Let me unpack those two impacts. On share-based compensation, we recorded an expense of approximately CAD 103 million in the quarter, driven by IPO-related modifications to Apotex's legacy management equity plan that was put in place when the company was private.
This was a non-cash expense and represents a one-time accounting charge associated with converting and modifying pre-IPO awards, and was largely driven by the modification of the vesting provisions of the company's share-based compensation plans in connection with the IPO. Next is the impact from foreign exchange. While a strengthening U.S. dollar typically has a positive foreign exchange impact on revenue and adjusted EBITDA, it negatively impacts liabilities on our balance sheet, which are denominated in U.S. dollars. This resulted in a foreign exchange loss in the quarter, which impacted net income. Adjusted net income was CAD 142 million, down 19% year-over-year, consistent with the lower gross profit contribution comparison from the prior year exclusive launch dynamic. Now let me give you some color on our revenue performance by market. Canada continued to be a standout contributor, driving 11% growth and representing 49% of revenue.
Performance was supported by strong execution of recent first-to-market launches, and we are seeing accelerating demand for our recently launched semaglutide product. Additionally, our biosimilar portfolio and our women's health portfolio delivered double-digit growth in the quarter. In the U.S., which represented 43% of revenue, the year-over-year decline of approximately 9%, excluding the VLLP, was anticipated, and it reflects the impact of a comparison to the prior year naloxone launch, which benefited from 180-day first to market exclusivity. Additionally, results were impacted by the planned temporary pause in ophthalmic sales in the U.S., where the magnitude was aligned with our expectations. Our launch calendar can impact year-over-year comparisons as our objective is to be first to market. This is the case with Q1 and partly Q2 of this year.
In Q1, the impact was partially offset by the first to market launches of our two sitagliptin products in Q1 of this year. We expect a strong growth comparison in Q3 and Q4 with a first-to-market exclusive launch planned in this year for those periods. In addition to the momentum from launches already in market and the benefit of the Cumberland transaction. International represented 9% of revenue, with 8% growth driven by the strength in LATAM that was partially offset by declines in the Middle East, resulting from the ongoing geopolitical conflict and decline in certain products. Overall, the quarter reflects continued strength in our core markets and the benefit of disciplined launch execution. Now looking at the drivers of revenue by Journey of Health business line.
Excluding the VLLP, conventional generics grew 16% versus prior year, reflecting the strong launch execution with our ongoing focus on first-to-market entry across both Canada and the U.S. This growth was partially offset by normal course market erosion in the existing portfolio in the U.S. Specialty generics declined 18%, driven by two anticipated factors. First, the year-over-year comparison reflects the prior year launch of naloxone in the U.S. And second, results were impacted by the planned temporary pause in ophthalmic sales as we complete equipment upgrades to our Richmond Hill site. Brands and biosimilars increased approximately 8% versus prior year, supported by continued strength in PROVIGIL from increased government business in the U.S., biosimilars growth in Canada, and growth in Searchlight from the strength in our women's health portfolio, as well as growth from Amprev.
This performance was partially offset by lower sales for some of our branded products in the Middle East. Turning to the balance sheet, we ended the quarter in a strong financial position with enhanced flexibility following the successful completion of our IPO. Net debt was approximately CAD 2.2 billion at quarter end, down from CAD 2.9 billion at the end of March, reflecting the use of net IPO proceeds to reduce total debt. As a result, our net leverage ratio is 2.2 times. We also ended the quarter with CAD 259 million of cash on hand. This cash position reflects normal operational requirements as well as planned near-term outflows in Q2, including the CAD 150 million payment of contingent consideration and the CAD 142 million payment to complete the Cumberland transaction, which we closed on July 1st.
Importantly, our balance sheet strength was further reinforced during the quarter with an investment-grade rating from DBRS Morningstar and a renegotiation of our credit facility with improved terms, including lower interest costs, release of security interest, and an increased revolver. This rating, together with lower leverage and strong operating free cash flow, gives us the financial flexibility to continue investing in our growth priorities while maintaining the disciplined approach to capital allocation. Operating free cash flow was CAD 142 million in the quarter, CAD 56 million better than the prior year on an ex VLLP basis, reflecting higher cash flow from operating activities. In the quarter, we continued to settle pre-acquisition U.S. legal liabilities, which have been fully provided for in our financial statements.
Overall, we believe we have entered fiscal 2027 with a healthy balance sheet and improved leverage profile and the flexibility required to support both organic growth and strategic portfolio expansion. Now I'd like to spend a few minutes on our annual guidance for fiscal 2027. I'd like to note that our target fiscal 2027 year-over-year growth comparisons exclude the VLLP from fiscal 2026, which provides a clearer view of the underlying performance and growth trajectory of the business. For the full year, we are targeting upper mid-single-digit revenue growth excluding the VLLP. This growth is expected to be supported by continued execution of our launch pipeline, which we expect to contribute more than 10% of revenue, including a 100 daily day exclusive product in the U.S. in the second half of the year.
Growth is also expected to be supported by our ongoing focus on first to market launches across Canada and the U.S., as well as the contributions from semaglutide in Canada and the Cumberland portfolio in the U.S. We also expect adjusted EBITDA margin to be in the 30% range, supported by ongoing progress of our productivity initiatives as well as product mix that reflects our Journey of Health diversification strategy and continued launch execution. While our first quarter adjusted EBITDA and margin were above expectations, the quarter benefited from lower than expected competition for certain key launches. Quarter-to-quarter fluctuations are a normal part of our business given the timing of significant launch opportunities and our priority to be first to market. Overall, our first quarter performance and full-year outlook support our confidence in achieving our fiscal 2027 objectives.
We remain focused on pipeline execution, productivity initiatives, portfolio diversification, and disciplined capital allocation. Thank you for your time today. With that, I will hand the call back to Jeff for his closing remarks. Jeff?
Before we move to take questions, let me briefly summarize what we believe is a strong start to our journey as a public company. The quarter reflected continued execution against our Journey of Health strategy. We delivered a solid first quarter, introduced FY 2027 guidance, and saw strong performance in Canada, supported by a successful product launch execution. We also continued to advance our pipeline across priority markets, including several first-to-market opportunities. At the same time, the Cumberland portfolio expansion transaction broadened our U.S. branded medicines platform and further diversified our growth profile. Importantly, the successful completion of our IPO strengthened our balance sheet and enhanced our financial flexibility, providing additional capacity to invest in organic growth opportunities while remaining disciplined in our approach to capital allocation.
While we are only one quarter into our first year as a public company, we are encouraged by the momentum we are seeing across the business. Our priorities remain unchanged: executing our Journey of Health strategy, leveraging our leadership position in Canada, expanding higher-value product platforms across North America, and continuing to build a more diversified, resilient, and growth-oriented business. Our North American footprint remains a clear strength. As a proven onshore player with a strong supply track record, Apotex is well-positioned to support customers and patients with reliable access to high-quality medicines across our key markets. With that, operator, we would be pleased to take questions.
Thank you. Ladies and gentlemen, we will now conduct a question and answer session. If you have a question, please press the pound key followed by one on your touch-tone phone. You will hear a one-tone prompt acknowledging your request. Your questions will be polled in the order they are received. If you would like to decline from the polling process, please press the pound key. Please ensure you lift the handset if you are using a speakerphone before pressing any keys. Please limit your question to one question and one follow-up only. Thank you. Your first question comes from Louise Chen with Scotiabank. Please go ahead.
Hi. Congratulations on all the progress in the quarter, and thank you for taking my questions here. I wonder-
I want to ask you about the semaglutide opportunity and how we should think about sales this quarter for the product and in the future quarters, and if you can pick up any share for a competitor that's actually out of the market until November. Thank you.
Yeah. Good morning. Thanks, Louise. Yes, with regards to semaglutide, first of all, we're really pleased to be the first Canadian company and the only company out there right now having launched the product. We're seeing tremendous success. Of course, we have some unexpected demand increasing that has left us alone as an exclusive company out in the launch. We are building to the increased demand. We do see this as an opportunity. We do foresee, based on what we're hearing, competitors to re-enter in November, but it has provided us with an opportunity to continue to strengthen our position and build share, which sets us up nicely, we believe, for the rest of the year when competition does resume. Great launch. I think it really speaks to the first-to-market opportunity as well as launching into a complex generic space.
Thank you.
Louise, your follow-up question, sales?
Yeah. My follow-up question was regarding the breakout of the in launch revenue guidance that you gave. Can you give any more color on which segments of the business that will be attributed to? Thank you.
Good morning, Louise. As we look at our in launch performance over the course of the year, it is very much in line with our diversification strategy and accelerating our Journey of Health. We have a number of exciting launches this year that will deliver more than 10% of our revenues. You've seen some of them in the first quarter, the semaglutide launch, the sitagliptin launches, as well as mirabegron that we launched in Canada. As we look at the balance of the year, we see an acceleration of growth in the second half of the year as we get launch momentum around those products, launch in a 180-day exclusive product in the U.S. and see growth from the Cumberland transaction, as well as continued growth in our base business.
Thank you.
Thank you. The next question comes from Evan Seigerman with BMO. Please go ahead.
Hi, all. Thank you so much for taking my question, and congrats on your first quarter as a public company. One on generic semaglutide and then one on the CAD 100 million productivity on savings. As you think about the obesity opportunity, are you seeing any uptake of the Ozempic generic in the patients who are looking to lose weight? Can you provide us an update on the potential for the 2.4 milligram dose? I know that that's not yet available despite the approval. Where are we with the CAD 100 million in productivity savings so far into the fiscal year 2027? Thank you so much.
Yeah. Good morning. Thanks, Evan. When we think of semaglutide, I would say it is early days. We're just into the launch of the market. Just as a reminder, we see Ozempic with the indication for type 2 diabetes, and we see that starting to build out there. As we see continual growth in the market as we're coming online, we don't have a clear indication of weight loss just because we're still in an indication for type 2 diabetes. Perhaps what I'll do is let Martin, who's launching the product now, as we see, comment further on in-market activities on the product.
Yes. Thank you, Jeff. Just to add to what Jeff just mentioned, we are planning to launch SEVMIA, which is our semaglutide indicated for obesity. We're planning to launch this product in fiscal year 2027. We're in commercial preparation at this point, and we're very excited to launch this product this year. But obviously, this will take some time.
Yeah. Thanks, Martin. On productivity, Evan, we continue to make good progress there against our target. We see CAD 100 million certainly in our sights for 2027, and we've had really strong progress on achieving that in completing our first quarter. Things are on track on our productivity initiatives.
Great. Thank you.
Thank you. The next question comes from Douglas Miehm with RBC Capital Markets. Please go ahead.
Yeah. Thank you. Congratulations from me as well. I'd like to drill down a little bit more on the semaglutide situation. We do know that Novo Nordisk launched their savings cards, and then they also have registered authorized generics as well for this market. What impact are you seeing from these defensive tactics as it relates to the private cash pay versus public markets, and what do you think your share is? On top of that, can you quantify Apotex's current share within these two markets specifically, especially since Ratiopharm has been offline? Do you have sufficient supply? If you don't right now, what's the bottleneck among your Indian companies at the moment?
Okay. So Doug, just unpacking those questions, let's take the last one first in terms of where the bottleneck is in supply.
Yeah, I think, Doug, Jeff here. Good morning. Thanks for the question. I think if we think about semaglutide as a complex share, Doug, it has a complex supply chain attached to it. We think of the complexity of sterile manufacturing certainly attached to devices. Hard to say where the bottlenecks are for us. I think as we're growing into the increased demand, certainly if you think of pens and pen manufacturing can be a bottleneck, but I think overall, it's really just managing the supply chain from end to end. And I think that really anchors back into really focusing on your partnership model that we certainly spend a fair amount of time on and making sure that we have capability within the partners and to certainly signal them when we have opportunities to grow. The complexity, really, we have had to build into this unexpected.
By the way, we feel good about the opportunity that we are able to grow into it, but just as we grow into our volumes, it has to be in a very measured way as we look to the moving pieces within the supply chain. But we ultimately believe we're closing the gap on demand in the market.
And the-
On the second question.
With regards to-
Of our tentative.
Yeah, maybe I can take it. Martin here. With regards to the authorized generic that Novo Nordisk was planning to launch. Although we know that they have planned to launch this product, although we have not seen any trace of current launch in the market today. They've been very proactive, I would say, to try to retain their existing patients on the private side, on the cash side. But obviously this is something that we were expecting from the very beginning.
On share, you asked a question about share, Doug, yeah. It's really early days. I think it's important to note that the market is still building. The brand holds the vast majority of the share. We are building share as well. That will evolve as other competitors come into the market. I think it's also important to note that the public market and access to that market for generics has just opened up in the month of July. The market is still building, and we don't have a good signal on that yet right now. But, as you know, the share, we can only speak to June, which is predominantly private market. The majority of the share is held by the brand right now. And we hold the remainder of the share with a very small portion held by another competitor.
Okay, and as a follow-up, I just want to touch on the biosimilars in Canada. You already have Sentys, Prolia, and Jeva approved, but they're not yet marketed. Can you walk us through timelines for the introduction of these products and expected opportunity? Because you have indicated that you expect that business to double over the next five years or so. And then you, Ben. Thank you.
Yeah. Martin here. We're in the final stage of launching these products, and we're very excited by these opportunities. We should be able to actually, potentially at the end of Q2, to report on those launches and more details.
Great. Thank you.
Thank you. The next question comes from Dennis Ding with Jefferies. Please go ahead.
Hi, everybody. Thanks for taking my questions and congrats on the IPO and all the progress. Number one, on revenue, I guess how should we think about the quarterly phasing through the year? In the first quarter, you grew 2%, but it is off a really tough comp, so I understand that. You also commented on double-digit growth in second half. I wonder why Q2 should also be strong as well because of an easy comp, and what is exactly driving the double-digit growth in Q4 specifically? As a follow-up for the Richmond Hill facility, how is the remediation process going, and when could that get back online? Maybe remind us how much revenue that facility typically produces. Thanks so much.
Thanks for your question, Dennis. It is Brian. Maybe I will start with the full year on revenue, then I will talk about quarter and the second quarter. On the full year, we benefit from the strength of our launch activity and launches in total over the course of the year, representing more than 10% of our total revenue. In the back half, we expect to see continued launch momentum from the products that we have launched in the first quarter, along with a 180-day exclusive product in the U.S. and the benefit of the Cumberland transaction that we have just closed on July 1st, in combination with continued growth in our base business, both in the Searchlight and PREP businesses, as well as biosimilars and our Canadian generics and LATAM portfolios.
The first quarter saw very strong performance again with launches representing more than 10% of our revenue in the quarter and a benefit, particularly in the U.S., from one of our launches, which had less competition than we expected. In the second quarter, we expect that competition to continue. Like the first quarter where we had a comparison to a prior year, 180-day exclusive launch product, we will see some of that impact in the second quarter as well in a year-over-year comparison. However, setting aside the comparison to last year, that broad portfolio of launches that we had this year continues to gain momentum, and we expect to deliver more than 10% of our revenue as a result. Our quarterly comparisons can fluctuate with our launch calendar, which is designed to prioritize first-to-market launches, which may be different in any given quarter in any given year.
Dennis, it's Jeff here. I'll take the Richmond Hill question. We have good momentum there working through our remediation, roughly more than two-thirds of our way there. Our expectation is that the site and the remediation progress will be ready by end of calendar year, along with the installation of our new technology ophthalmic line, which we're referring to as Opo3 will be ready. So by end of this calendar year, we expect to be able to be in a position to ask FDA to come back for re-inspection of the site and qualification of the line. Just touching on your question around revenue, it's not a material part of our business, actually less than 1.5%, but nonetheless, a very important part of our portfolio.
Thanks so much.
Thank you. The next question comes from Michael Nedelcovych with TD Cowen. Please go ahead.
Thank you for the questions. My first relates to the generic drug tariffs that were announced by the U.S. government recently. What are the steps between now and 2027 that Apotex plans to take to mitigate that risk? My second question relates to your top-line growth ambitions. Apotex management is comprised of veterans of the generic pharmaceuticals industry. You all have decades of experience in the business between yourselves. When the company brings that experience to bear in setting its revenue growth targets, would you say that you have arrived at ambitions that are easily achievable, roughly similar to peers, or relatively lofty compared to history of the industry? Thank you.
Thank you. Maybe I'll start with the tariff question. I think this is certainly an important topic for us that we've been dealing with for some time now. We certainly understand the objectives of the U.S. administration, which really don't differ that much from the Canadian domestic policy on really building out a sovereign domestic supply chain that can be counted on. We have been engaged, certainly with the administration and with the associations. I do have Christine here with me who is actively engaged on behalf of Apotex. Maybe I'll let her round out some of the activities that have been going on and what we see between now and 2027.
This announcement, obviously on social media, is not yet proven policy. That said, Canada and Canadian companies got a real jump start on working on tariffs because you'll remember back when the first administration's target for tariffs was uniquely Canadian. So we have really deep relationships with the administration on these topics. And I would just say that our goals, echoing Jeff, are very much aligned to what the administration is trying to accomplish and where there is very specific policy that's published focusing on essential medicine, reshoring to North America and other specific issues on APIs. We are very much engaged in all the right parts of the administration in executing.
Yes. Michael, it's Brian. In terms of your question around top-line growth, our growth is predicated on execution of our Journey of Health, and that's over 480 products that we're launching over the next five years and includes, importantly, diversification outside of generics, including the Searchlight, Camprab and the portfolio expansion transaction that we've recently completed. Our growth is actually higher. While we'll see growth in all aspects of our business, our growth is higher outside of generics as we progress on our Journey of Health, and we should see the highest level of growth in brands and biosimilars consistent with the recent activity that we've done.
While we do, and we're quite proud of the team that has a strong background in generics, we're much bigger than that as a company, and our growth ambitions extend well beyond conventional generics to see us having a portfolio which is pretty broad by fiscal 2031, with each of our business lines representing about a third of our portfolio.
Thanks, everybody.
Yeah.
Thank you. The next question comes from Erin Kyle with CIBC. Please go ahead.
Hi, good morning, and congrats on the strong first quarter. Thanks for taking the questions here. I was wondering if you could discuss the U.S. segment performance in the quarter, and I think you touched on it a bit earlier in response to a question, but the gross profit was quite strong and well above our expectations. The MD&A mentions product mix as a driver, but just wondering if you can elaborate on that a bit more in Q1.
You want me to start?
Yeah, thank you for the question, Erin. As we look at our U.S. performance, first, just looking at revenue, while it was a comparison to a very strong prior year, which included a 180-day exclusive product. We saw a nice start to the year with our launches in the year, particularly sitagliptin, the sitagliptin products that we launched. That not only contributed to our top line, it also contributed to our bottom line. That performance in sitagliptin, we were able to enter the market with one of the products that had fewer competitors than we had expected, and as a result contributed to higher margins in the quarter. We have had a really nice start on that particular product.
We expect into the second quarter, we will ultimately see the competition that we had expected, and we will see our margins start to get back to those normal levels that we are planning over the course of the year.
Thank you. That is helpful color there. Then maybe just as my follow-up question, just switching gears to capital allocation here, and maybe as we think about on the M&A front as part of the growth strategy, what types of transactions should we anticipate from Apotex similar in size to recent deals for Apotex? Would you consider anything larger or transformational?
Yeah. Thanks, Erin. If we think about acquisitions, kind of back into our Journey of Health, really looking at portfolio expansions into your reference of Cumberland, we really like these opportunities to expand out into therapeutic areas like Cumberland and continue to work through portfolio expansion opportunities that will continue to grow a Cumberland Searchlight, some of the assets that we already have in place. So we will continue to focus on those opportunities on expanding the portfolio. As we think about selective M&A, just as a reminder, we do not have that built into any of our forward-looking guidance in terms of our numbers. Selective M&A for us really could anchor back into an opportunity in an institutional space going forward, filling out some of the areas that we do not have coverage in now.
By and large, while we are taking a close look at what the opportunities are for selective M&A, we really have our efforts focused on increasing the portfolio basket in the lines of business that are driving higher margins. Cumberland is a perfect example. We will continue to work through those targets, and we are quite active in that area right now as we speak. But once again, we will continue to keep an eye on the market and opportunities that could be accretive down the road from an M&A point of view.
With respect to your question on transformational M&A, while that is not in our plan, we maintain a very healthy balance sheet that gives us the capacity to entertain a number of opportunities to help accelerate our Journey of Health. As we look at that, we certainly have the capacity to do that. We are very disciplined, though, in our approach around M&A, which includes several key filters, starting with a strategic filter around complementing our Journey of Health strategy, along with a number of financial filters, and ultimately ensuring that we can continue to maintain that healthy balance sheet, targeting that leverage ratio in the 2.5x range.
Thank you. I will pass the line.
Thank you. The next question comes from Gary Ho with Desjardins Capital Markets . Please go ahead.
Thanks. Good morning, and congrats on the quarter and the IPO. I wanted to go back to the EBITDA margin discussion. So 30.6% this quarter, and yet you are targeting 30% range. I think, Brian, you alluded to some of the lumpiness that could happen. Are you expecting, I guess, the balance of this year to be stable and moderating for the remainder of this year? Or is there some conservatism built into that 30%?
Yeah. As we look at our margins and our growth from quarter to quarter, it can vary because of our launch portfolio and competitive circumstances. As we look at the first quarter, we did see a lift in the U.S. as a result of less competition on one particular launch. We expect that to normalize in the second quarter. We could see another slight lift in the third quarter as we are launching a first to market, 180 day exclusive product in the U.S. and in that quarter. But overall, we expect to operate in a reasonably tight margin band across all the quarters. But you can see some variability just driven by the timing of our launch calendar.
Okay, great. As my follow-up, just going back to the U.S. tariffs discussion, maybe for Jeff or Christine. I know it is not policy yet, but I am guessing you have assessed maybe perhaps some contingency plans, high level, what could those look like? Perhaps talk about how long those plans might take to implement.
Yeah, I think as mentioned, it is early days for us, so we continue to work closely and certainly stay in touch with the administration, and are certainly supportive of where the policy will eventually go. I think we feel like we are in a really good position here. We have got assets right here located in Canada that really cover APIs, solid dose, and liquid dose business. So we are well-positioned to continue to supply the U.S. market and actually expand on these assets to meet some of the needs. I think while we understand how this will be, how we will get after this, and how we will receive, I guess, further information on how we should be thinking about it, we will stay closely in tune with it, but we feel like we are well covered. It is a complicated supply chain, as a reminder.
It's a very important part, obviously, maintaining the health and continued supply of these products. Yeah, once again, the dialogue has been going on for a couple of years now, so we feel like we're fairly well-versed. Christine, feel free to add anything in or if I covered it.
I think you covered it. It's early days. We are aligned with the administration's overall goals, and we will find the best way to support both of our lead markets, both Canada and the U.S., in their desire to have protection against a complicated geopolitical supply chain. The one thing that is obvious to me from the tweet announcing the tariff is a recognition of the importance of the generic supply chain and the global nature. We're led by a president in the U.S. who isn't often for patience, and he announced a tariff that would begin in 2028. That's recognition of the complication of the geopolitical supply chain and gives us, especially a company like Apotex, a lot of time for the dialogue to make sure that we're in the right place at the right time.
Okay, great. Okay, thanks for taking my questions.
Thank you. The next question comes from Tania Gonsalves with Canaccord Genuity. Please go ahead.
Hi, good morning, guys. First question from me, you called out some higher inventory provisions as one of the factors weighing on gross margin this quarter. Can you provide some color on what drove that step up in provisioning, whether it was concentrated in any particular products or business lines, and whether we should expect this to be a one-time item or something that might persist through the year?
I would just say this is normal operations, and you will see this ebb and flow over the quarters. We are constantly looking at our inventory and our production and taking provisions where we see that we may have a little bit more inventory on a specific product that we need or if our needs change. I would not take Q1's results as a signal that anything unusual happened in the quarter. It is really just timing around the business that we operate.
Okay, perfect. My follow-up, sticking to the line of questioning on tariffs, as you sign new BD agreements today for products expected to launch several years from now, are you already changing where those products will be manufactured in anticipation of potential U.S. tariffs? Has the tariff uncertainty changed either the type of assets you are looking at or the relative attractiveness of U.S. manufacturing assets?
There is no simple answer to that. Obviously, the political landscape and the policy landscape that we anticipate is a factor that we analyze any time that we do a partnership deal. I would not say that we have had a wholesale change in our overall strategy. I would say that as the administration continues to focus on China as a specific threat or concern, we definitely take that into consideration, but that is probably the only additional real factor that we have.
Yeah, I'll just add to Christine's comment around assets. As mentioned, we feel really well-positioned here in North America. But I also want to just highlight the opportunity with our Halo asset, where we had increased capacity of a sterile line manufacturer. And there's a good example where it might not seem like an obvious investment, but it adds critical products in sterile manufacturing into the U.S., putting in more capacity. It's a facility that was willing to do it, so we are able to take advantage of a facility in place and investment that will start to also meet the needs of the government in increasing products like sterile manufacturing. So those types of initiatives could be part of how we look at assets as we go forward.
But as Christine says, it's very fluid, and we have the signals in place to really, as we look at our forward-looking portfolio, to continue to take all of those considerations in in how we look into the 2030 cycles of developing products and getting ready to launch products in the U.S.
Thank you. I'll pass the line.
Thank you. The next question comes from Michael Freeman with Raymond James. Please go ahead.
Hey, good morning, team. Congrats on all the progress and thanks for this question. First question is on portfolio expansion opportunities and M&A. You mentioned that you are quite active in looking for portfolio expansion opportunities, and I wonder if you could describe the competitive environment out there and how you are seeing pricing fluctuate, perhaps from the time that you undertook the Cumberland transaction and even looking back to the Searchlight transaction. How is pricing and competition looking there? And I have a follow-up.
Yeah, so as I mentioned, we continue to work here and it really also kind of layers back into our partner of choice as we think about developing out our strategy in these portfolios, and this kind of layers into this portfolio expansion. We lots of opportunities out there. We see opportunities around the globe, not just here in North America, to think about parts of the portfolio that we can certainly grow into, and more importantly, add products into assets that we have that are ongoing and have momentum. The opportunities remain rich. Really can not speak to any of the dynamics around pricing, but I think these conversations have been certainly building momentum for us over the past couple years, not just post-IPO.
We have got a pretty good handle on the targets that we are looking at, the opportunities, and as we build out Cumberland, as you think about Cumberland, we just now add more opportunities with partners that we can layer into there. We are feeling good about it, but once again, when we think about the opportunities here, we are going to maintain a disciplined approach. We are looking for assets that are going to drive margin accretion and our return on invested capital. As we look to build out the portfolio, we will make sure we stay quite disciplined in executing to developing that margin accretion of 30% and the return on invested capital. Thanks.
Okay. All right. Thanks, Jeff. My second question is on, I noticed that there is a trademark filed for something called Apotex Direct, relating to pharmacy services, online retail pharmacy activities. I wonder if you are able to shed any more light on what this is.
If we think about Apotex Direct and the filing of that trademark, it was really just for future-looking. There are no plans with that right now. It's really just protecting the brand and the trademark. We've seen some other competitors out there filing a similar type of trademark, so we just wanted to make sure that as we look forward at Apotex and that we cover the brand for future potential moves that could be made, that we may not see, and that we are able to control the trademarks related to our company.
Good. All right. Thanks, team. I'll pass the line.
Thank you. Again, please limit your question to one question and one follow-up only. Thank you. The next question comes from Frederico Gomes with ATB Cormark. Please go ahead.
Morning. Thanks for the questions here. First question on the ophthalmic sales in the U.S. During this, I guess, temporary pause there, are you seeing competitors take share that might be difficult to regain once Richmond Hill is fully remediated? Or do you believe that you can regain that volume rapidly? Thank you.
I think to answer your first question, what did we see about our competitors being able to absorb our share? I think that's a bit of a mixed bag. It's a product-by-product analysis of which ones there was excess capacity for and which ones took a little bit of a longer time to transition, which is going to feed into my second answer about how much share can we take back. We continue to see the ophthalmic space in the U.S. being disrupted. There's a lot of different issues that go on.
We will work closely with our customers and prioritize the products that they are looking for more stable supply, and we will work with our supply chain to bring those back in a sequential manner to ensure that we have the supply standard that Apotex is known for in our customer base, and we would expect that we would be able to get the majority of our overall value back.
Thank you. Second question is on the impact of the company in the Middle East. What is your relative exposure there currently within that international segment? I wonder how much of a, I guess, a continued drag is baked into your fiscal year guidance.
Yeah. Hi, Frederico. This is Brian. I'll take that question. As we look at the impact of the Middle East, it has impacts across a number of areas of our business. If we first think about the commercial business in the Middle East, that started with some logistical considerations around getting our product into that market. I think we have largely recovered in that space. But as you can imagine, the demand is lower than it would normally be with less travel and fewer expats in the region right now. That said, the Middle East as a commercial entity for us is a smaller portion of our business. As we expect to see over time, that start to normalize for us, but not have a significant impact on our overall results.
What we are monitoring more closely is the knock-on impact of pricing and just general supply chain around the world as a result of this conflict. So far, we have been able to manage it quite well. We haven't seen material cost inflation or challenges around receiving key materials for our production and for our business. As we look over the course of the balance of the year, that's something that we are watching very closely. Again, to date, haven't really seen a material impact or anything to be concerned about.
Thank you.
Thank you. The next question comes from David Martin with Bloom Burton. Please go ahead.
Good morning, and congratulations on the quarter. Regarding the challenges in producing semaglutide at scale with high purity, are the challenges so complex that you expect they will keep other ANDA filers in Canada permanently off the market? Could they have led to Dr. Reddy's API impurity issue, or should they be resolvable over time?
Yeah, thank you for the question, David. I think if we think about just in general, sterile manufacturing products, I think bring with it a different level of complexity. I think understanding your supply chain and as we think of working through the lines of business and working up into complex generics into brands of biosimilars, they do bring, I think, different levels of complexity in the supply chain naturally. I think having a good understanding of your supply chain, first and foremost, if you haven't had experiences, we think about our strategy in contemplating that. We certainly have eyes wide open on how we are managing it. It does provide a bit of a barrier for competitors.
It's just naturally as we move up these lines of business, whether it's complex formulations or that have attached to them these complex supply chains, they do just in and of themselves provide a barrier for competition and understanding those supply chains are critical, and as we see certainly the opportunity that was unplanned for us, once again, being the sole supplier in the market, you have to work carefully with your suppliers, but it's important to understand the supply chain, but not only that, have suppliers that are willing to grow into that opportunity and demand with you. While we anticipate competition coming in the late fall, we do see this as a really good opportunity for us to continue to leverage our relationships and these strong partnerships we have.
We'll continue to work upstream in our lines of business in launching more of these types of products.
Okay, and my second question, in Canada, as more generics enter the market and prices decrease, do you typically see the pharma companies continue to offer greater savings on the brand products to chase down the out-of-pocket cost of generics? Or do they eventually throw in the towel at some point?
Well, it's a good question. I don't think you can look at it as an industry-wide. I think it tends to be company specific on how they will react to the competition, and we've seen that if you go back, David, really in all of our market segments and product segments where we launch into, companies will have, I guess, best to kind of categorize almost an individual response to it. So we fully anticipate as we launch into markets that we will meet with some levels of resistance at certain points in time. Sometimes it's expected. We're always expecting it. Sometimes you don't see it. But I think some companies will absolutely defend the franchise on their products.
But we're quite comfortable competing in this space, and we're trying to anticipate that level of competition and how it will react to what we see real time in the market as we're trying to get out there and grow our brand and grow our share.
Okay, thanks. That's it for me.
Thank you. The next question comes from Justin Keywood with Stifel. Please go ahead.
Good morning. Thanks for taking my call. Nice to see the results. On the historic patent cliff of CAD 300 billion of branded RX revenue at risk over the next five years, how should we view the cadence of Apotex's new product launches for that opportunity, and is it tracking to early expectations?
Well, I think we are entering a period, and from time to time, you see these periods pop up around loss of exclusivity, and we are no doubt, to your point, in one of those. I think as we have been anchoring back into our 480 odd products that we'll be launching over the next five years, just as a reference point, close to 200 of those in our core markets being Canada and the U.S., we do anticipate that we'll be launching them first to market roughly 70% of the time. We feel very good about where we are. Many of the products are post-submission. We feel very good in our positioning on first to market and exclusivity. What we wouldn't have visibility to is other companies and when they may roll off of a patent that we don't have visibility to.
But we feel like we're very well positioned to continue to maintain our leadership around first to market and seeing that execute within that loss of exclusivity in the landscape of those products that are coming our way.
While our objectives are slightly different in capturing that value in the United States and in Canada, there is one thing that is consistent across both those markets is that we're selective and focused on value. We're not looking to participate in every product that comes off of exclusivity. We're looking to focus on those that drive the most value and benefit in the market.
That is very helpful, and that lends to my follow-up question. Is there a particular target therapeutic area or areas to steer the portfolio? I know Apotex has had strong presence in ophthalmology and oncology. Is that a continued pursuit or are there any strategic shifts to note?
I think the best way to look at that is by market. If we think of the Canadian market, we are certainly well integrated here with therapeutic areas in place. We think of our biosimilars looking in ophthalmology, oncology. We go over to Searchlight, we have women's health and derm. I think if you think about the U.S. market as we are expanding into those therapeutic areas, a good example was just looking at our Cumberland acquisition, which once again gives us an opportunity into the institutional space of looking at acute care, oncology, pain, gastroenterology. The U.S., we are still, I would say, building out those therapeutic areas and continuing to look at a couple other potential targeted areas. We will continue to build into that. Canada, we feel like we are pretty well established.
Those assets are in place, and rolling back to some of the previous questions around portfolio expansion, that is where you are really now filling those portfolios into assets that are in place. The U.S., we are expanding into Cumberland and existing assets, but also still looking for other opportunities around increasing the therapeutic areas.
Thank you very much.
Thank you. The next question comes from Scott McAuley with Paradigm Capital. Please go ahead.
Morning, everyone. Thanks for taking the questions. First off, just on the Cumberland portfolio, and great to hear that acquisition closing. How are you seeing the early days of that integration of products, process, any people, any costs associated with that, kind of the first month and a half of that acquisition closing?
Yeah. The transaction closed the first of July, as you noted, and we're very happy with the transition so far to date. It's still early days, and we're working very hard to unlock the additional value that we see in that asset. As far as cost?
Yeah. There aren't significant costs from an integration standpoint. We've acquired the commercial assets of Cumberland and a very small focused sales and marketing team that comes along with that. Right now, we're just focusing on giving them the resources that they need to be successful, but don't view that as a material integration cost for the company.
That's great. And lastly, on the kind of lot of discussions on the U.S. policy. How about in Canada? Are there any kind of ongoing discussions on policy related to promoting domestic manufacturing and onshoring from the Canadian perspective?
Yeah, we've had very good conversations with the Canadian government. They remain extremely supportive and no less focused on increasing the capability of domestic sovereignty here. We are in a really unique position as we look at our dialogue with the Canadian government because you could almost think about Apotex in Canada as an anchor company. We have significant scientific resources here. We have API production here. We have immense capacity on our solid dose facilities. So we really have the assets here. It's really how can we work closely with the government to build out and to strengthen the continued assets, and then look at really where there may be gaps for industry here in Canada.
So we've had very good dialogue, certainly engaged, and the government's been tremendously supportive in trying to understand our needs and what really would be quite helpful, I guess, in terms of looking into the future from an industry perspective.
That's great to hear. Thank you very much.
Thank you. Our next and the last question comes from Nate Poe with National Bank Capital Markets. Please go ahead.
Good. Thank you for taking my question. My first one is related to the Health Canada's ministerial reliance order. Can you just give any color on how that might impact the competitive environment and perhaps your product launch timing?
Nate, could you repeat the question? You broke up. We got the Health Canada piece, we just didn't hear the whole thing.
Sure. Can you speak to the impact of Health Canada's ministerial reliance order and how that will impact the competitive environment and potentially product launch timing?
Are you referring to Again, you're breaking up when you're saying the order.
MRO.
MRO. Okay. Do we have your follow-up question, too?
My follow-up question would just be on the tariffs. From your knowledge, have your conversations thinking on how to address these different from your competitors in any way?
Yeah, referring to the reliance order, Nate, once again, we see this opportunity here is a good opportunity for domestic manufacturers. It's a recognition that developing products and having assets here in Canada could give you some, we'll say, preferential focus on really looking at the files. We think as you think about the government, you think about Health Canada, they are resource limited as well, so they're trying to get to the highest opportunity for savings for Canadian patients and access and taxpayers. If you think about being a domestic manufacturer, it's a nice way to really recognize the assets that are being developed here at home and investments that are taking place here in the country. So early days to see how this will roll out in terms of what advantages it could give us.
I think it's good focus for the government to have to be working with industry and local industry and how we are placing investments and having recognition for those investments.
Maybe just to add to this on the reliance order. Health Canada will prioritize brands. At this point in time, generics are not in scope, and that's another signal that Health Canada recognize the importance of favoring local domestic manufacturers. At this point in time, the focus is really on brands.
Nate, your other question?
Question. Thank you. Is on the U.S. tariffs. From your knowledge, or have your conversations or thinking on how to address them differed from any of your competitors?
U.S. tariffs.
I can't speak to the conversations that the administration has with our competitors. What I can say is there is a unique recognition of Canada as sort of a solution. The fact that we're North American based is very much on a core message associated with the goals of the administration. I don't know what's happening in the competitors' conversations, but obviously those dynamics that are unique to Canada are a good potential advantage for us.
All right. Well, thank you everybody for joining us today and for all of your questions. We'll be available following the call and over the next several days to address any follow-up inquiries. Please feel free to contact the investor relations team, and thank you for your continued interest in Apotex, and have a great day. Thank you.
Thank you. Ladies and gentlemen, this concludes the conference call for today. Thank you for your participation. You may now disconnect your line.