Apotex Health (TSX:APTX) Q1 2027 Earnings Call

0:00 Welcome to the Apotex First Quarter Fiscal twenty twenty seven Earnings Conference Call. At this time, all lines are in listen only mode. Following the presentation, we will conduct a question and answer session. Please

0:20 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 six a. M. Eastern Time this morning and can be found on the Investor and News section of our website and SEDAR plus Before we start, we'd like to remind you that all amounts discussed on this call are denominated in Canadian dollars 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.

1:12 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 and A, its earnings press release issued today and its IPO prospectus for additional

1:35 information. During this call, we will reference certain non IFRS financial measures. Please see our earnings press release and MD and 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 McClellan, Chief Financial Officer. Also joining us for the Q and A portion of today's call are Christine Bader, President of Apotex USA and LatAm and Martin Ariz, 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'll open the call for Q and A. And with that, I'll hand the call over to our CEO, Jeff Watson. Jeff?

2:27 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 four eighty planned launches over the next five years, and a manufacturing network built to deliver reliable supply at scale.

3:21 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 twenty twenty seven 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 execution, 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.

4:10 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 peri pursuit term loan in the amount of $800,000,000 launched several first to market products, completed the Cumberland portfolio expansion, and continued to execute productivity initiatives targeting more than 100,000,000 of savings in fiscal twenty twenty seven. We also continue 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 reinspection by the end of calendar year.

5:06 As previously disclosed, we made a commercial decision to halt production of U. S.-bound ophthalmic products from our OPTA-two line as we focused on efforts on qualifying our state of the art OPTA-three line. We expect to begin production for The U. S. Generic ophthalmology market upon successful reinspection 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.-found products produced in Canada.

5:53 We remain engaged directly and through industry associations with the U. S. Administration on how our footprint can be leveraged to benefit a 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 Pharmaceuticals, 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.

6:45 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 twenty twenty seven guidance, including upper mid single digit revenue growth, excluding the impact of VLLP and an adjusted EBITDA margin of approximately 30%.

7:45 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 nalotinib that benefited the prior year period.

8:35 We view this as launch calendar timing and have a similar launch planned 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 four eighty product launches over the next five years.

9:28 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.

9:38 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. And last month, we expanded our U. S. Hospital portfolio to the launch of injuvite 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.

10:25 Turning to Slide eight. The Cumberland portfolio expansion transaction represents an important step in the continued evolution of our U. S. Business. As we've discussed previously, our strategy is not simply about adding products. It's 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.

11:20 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're taking to position Apotex for long term growth. With that, I'll turn the call over to Brian to review our first quarter financial results and fiscal twenty twenty seven outlook in more detail. Thank you, Jeff, and good morning, everyone. Q1 set the right tone for fiscal 'twenty seven with the results slightly above expectations and a solid foundation for the balance of the year.

12:07 As a reminder, our year over year performance is presented excluding the contributions of the VLLP in fiscal twenty twenty six across a number of key financial metrics to provide a clearer view of the underlying business. The VLLP agreement expired in fiscal twenty twenty six with the bulk of the final sales under this agreement recorded in the first quarter of fiscal twenty twenty six and amounting to $3.00 $8,000,000 Revenue was $848,000,000 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 $421,000,000 a nominal decline versus prior year with gross margin of almost 50%.

12:54 The year over year decline ex VLLP primarily reflects the prior year contribution from the exclusive launch of nalotinib in The U. S, but was essentially offset by strong new launch performance and savings from our productivity initiatives. Adjusted EBITDA was $259,000,000 essentially in line with the prior year, and adjusted EBITDA margin was approximately 31%. We reported a net loss of $38,000,000 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 $103,000,000 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.

13:52 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 US 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 142,000,000 down 19% year over year, consistent with the lower gross profit contribution comparison from the prior year exclusive launch dynamic.

14:43 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 nalotinib launch, which benefited from one hundred and eighty day first to market exclusivity.

15:34 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.

16:19 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 lines. 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.

17:08 Specialty generics declined 18%, driven by two anticipated factors. First, the year over year comparison reflects the prior year launch of nalotinib in The US. And second, results were impacted by the planned temporary pause in ophthalmic sales as we complete equipment upgrades to our Richmond Hill site.

17:29 Brands and biosimilars increased approximately 8% versus prior year, supported by continued strength in Provigil from increased government business in The US, biosimilars growth in Canada, and growth in Searchlight from the strength in our women's health portfolio, as well as growth from Amprev.

17:49 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 $2,200,000,000 at quarter end, down from $2,900,000,000 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.

18:20 We also ended the quarter with $259,000,000 of cash on hand. This cash position reflects normal operational requirements as well as planned near term outflows in Q2, including the $150,000,000 payment of contingent consideration and the $142,000,000 payment to complete the Cumberland transaction, which we closed on July 1.

18:43 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.

19:15 Operating free cash flow was $142,000,000 in the quarter, dollars 56,000,000 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.

19:36 Overall, we believe we have entered fiscal twenty twenty seven 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 twenty twenty seven. I'd like to note that our target fiscal 'twenty seven year over year growth comparisons exclude the VLLP from fiscal 'twenty six, which provides a clearer view of the underlying performance and growth trajectory of the business.

20:08 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 one hundred and eighty day exclusive product in The U. S. In the second half of the year.

20:30 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.

21:01 While our first quarter adjusted EBITDA 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 'twenty seven objectives. We remain focused on pipeline execution, productivity initiatives, portfolio diversification, and disciplined capital allocation.

21:38 Thank you for your time today. With that, I'll 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 fiscal twenty twenty seven guidance and saw strong performance in Canada, supported by a successful product launch execution.

22:10 We also continue 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.

22:44 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.

23:10 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'd be pleased to take questions.

23:33 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 pulled 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 speaker phone before pressing any keys. Please limit your question to one question and one follow-up only.

24:08 Your first question comes from Louise Chen with Scotiabank. Congratulations on all the progress in the quarter, and thank you for taking my questions here. I wanted 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.

24:36 Yeah. Good morning. Thanks, Louise. Yes, with regards to the semaglutide, we 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, so we do see this as an opportunity. We do foresee, based on

25:07 what we're hearing, competitors to reenter 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. So great launch. I think it really speaks to the first to market opportunity as well as launching into a complex generic space.

25:31 Thank you. Louise, your follow-up question, sales?

25:39 Yes. So follow-up question I had 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. Sure. Good morning, Louise. As I as we look at our 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

26:10 of exciting launches this year that will deliver more than 10% of of our revenues. You've seen some of them in the first quarter, the semaglutide launch, sitagliptin launches, as well as mirabegron that we 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 one hundred and eighty day exclusive product in The U. S. And see growth from the Cumberland transaction as well as continued growth in our base business.

26:49 Thank you. Thank you. The next question comes from Ivan Sigerman with BMO. Please go ahead. Hi all. Thank you so much Congrats on your first quarter as a public company. One on generic semaglutide and then one on the $100,000,000 productivity savings. As you think about the obesity opportunity,

27:14 are you seeing any uptake of, you know, of the Ozempic generic in the patients who are looking to lose weight? And can you provide us an update on the potential for the two point four milligram dose? I know that that's not yet available despite the approval. And then where are we with the $100,000,000 in productivity savings

27:35 so far into the fiscal year 2027? Thank you so much.

27:41 Good morning. Thanks, Evan. Yeah. When we think of semaglutide, I would say it is early days. It's we're just into the launch of the market. Just as a reminder, we see Ozempic with the indication for type two diabetes, and we see that starting to build out there. So as we see continual growth in the market as we're coming online, we don't have a clear indication of weight loss yet because we're still in an indication for type two diabetes.

28:10 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. Yes, we are 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 twenty seven. We're in commercial preparation at this point.

28:37 And, you know, we're very excited to to launch this product this year. But obviously, this will take some time. Yeah. Thanks, Mark. And, yeah, on productivity, Emma, we continue to make good progress there against our against our target. We see $100,000,000 certainly in our sites for '27, and we've had really strong progress on achieving that in our first completing our first quarter. So things are on track on our productivity initiatives.

29:08 Great. Thank you. Thank you. The next question comes from Douglas May with RBC Capital Markets. Please go ahead. Thank you. Congratulations from me as well. I'd like to drill down a little bit more on semaglutide situation. So we do know that, Nova has launched their savings cards, and then they also registered

29:34 authorized generics as well for this market. So what impact are you seeing from these defensive tactics as it relates to the private and cash pay versus public markets? And what do you think your share is? And then on top of that, can you quantify,

29:53 Apotex's current share, within, this market these two markets specifically, especially since, Radius has been offline? And do you have sufficient supply?

30:07 And if you don't right now, what's the bottleneck, among your Indian, companies at the moment?

30:18 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 generic, Doug, it has a complex supply chain attached to it. We think of the complexity of sterile manufacturing certainly attached to to devices.

30:47 You know, hard hard to say where the bottlenecks are for us. I I think we we kind of as we're growing into the the increased demand, certainly, if you think of the 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 spent 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. So the complexity really has we have had to build into

31:17 this unexpected, by the way. I mean, 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 as we kind of look to the the the moving pieces within the supply chain. But we ultimately believe we're we're closing the gap on demand in the market. And the and on the second question With regards with regards to sent it. Yeah. Maybe I can take it. Martin here. With regards to the authorized generic, that Novo Nordisk was planning to launch. We know that they have planned to launch products, although we have not seen,

31:53 any trace of current launch in the market today. They've been very, proactive, I would say, to retain, try to retain their existing patients on the private side, on the cash side. But obviously, this is something that we're expecting from the very beginning.

32:13 On share. You've asked a question about share. It's it's really your early game. I think it's important to note that the market is is still building. The brand holds the vast majority of the share. We are building share as as well. That will evolve as other competitors come in 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.

32:43 So that market is still building, and we don't have a good signal that yet right now. But as you know, the share and we can only speak to June, which is predominantly private market. The majority of the shares held by the brand right now. And then we hold the remainder of the share with a very small portion held by another competitor. And as a follow-up, I just wanna touch on the biosimilars in Canada.

33:21 You already have Sintas, Prolia, and Giva approved, but they're not yet marketed. Can you walk us through timelines

33:34 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. In any event, thank you. Yeah. Martin here. This is, we're in the final stage of launching these products, and we're very excited by these opportunities. So, you should we should be able to actually potentially at the end of q two 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, good morning. Thanks for taking my questions and congrats on the IPO and all the progress.

34:21 So number one, on revenue, I guess, should we think about the quarterly phasing through the year? In the first quarter, you grew 2%, but it's off a really tough comp, so I understand that. And you also commented on double digit growth in second half. So I wonder why shouldn't Q2 also be strong as well because of an easy comp? And what's exactly driving the double digit growth in Q4 specifically?

34:46 And then as a follow-up for the Richmond Hill facility, how is the remediation process going? And when could that get back online? And maybe remind us how much revenue that facility typically produces? Thanks so much.

35:01 Thanks for your question, Dennis. It's it's Brian. Maybe I'll start with the the full year on revenue, and then I'll talk about the quarter in in the in the second quarter. But on the 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've launched in the first quarter, along with an hundred and eighty day exclusive product in The US and the benefit of the Cumberland transaction that we've just closed on July first first in combination with continued gross growth in our base business, both in the searchlight and product businesses as well as biosimilars and our Canadian generics and and LatAm portfolios.

35:51 The first quarter saw very strong performance, again, with launches representing more than 10% of our revenue in the

36:00 quarter, and a benefit particularly in The US from one of our launches, which had less competition than we expected. In the second quarter, we expect that competition to continue. But like the first quarter, where we had a comparison to a prior year one hundred and eighty day launch 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,

36:34 that broad portfolio of launches that we have this year continues to gain momentum, and we expect to deliver more than 10% of of our revenue as a result. Our 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 and in any given year.

36:59 Hey, 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 Alpha three, 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 reinspection of the site and qualification of the line. And just touching on your question around revenue,

37:34 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 Nabokovic with TD Cowen. Please go ahead. Hi, 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? And then my second question relates to your top line growth ambitions. Apotex management is comprised of veterans of the generic pharmaceuticals industry.

38:22 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 we'll just know, I think begin with 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 US 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. So we have been engaged, certainly, with the administration and with the associations.

39:14 I do have Christine here with me who is actively engaged on behalf of Apotex. Maybe I'll let her kind of round out some of the activities that have been going on and what we see between now and 2027. And this this announcement on, 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 at Going 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 medicines, reassuring to North America, and other specific issues on APIs, we are very much engaged in all the right parts of the administration in executing.

40:20 Hi, 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 four eighty products that we're launching over the next five years. And includes importantly diversification outside of generics, including the search like AMPREV 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. So 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 the conventional generics.

41:20 To see us having a portfolio which is pretty broad by fiscal 'thirty one with each of our business lines representing about a third of our portfolio. Thanks, everybody. 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 and A mentions product mix as a driver. But just wondering if you can elaborate on that a bit more in Q1.

42:11 You want start? Yeah. Thank you for the question, Eric. As as we look at our US performance, first, just looking at at revenue. While it was a comparison to a very strong prior year, which included a a one hundred and eighty day exclusive product, we saw a nice start to the year with our with our launches in the year, particularly Citiguptan the Citiguptan products that that we launched. And that not only contributed to our top line, it also contributed to our bottom line. That performance in in citagliptin, we're able to enter the market with one of the products that had fewer competitors than we had expected, and as a result, to higher margins in in the quarter. We've 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'll see our margin start to get back to those normal levels that we are planning over the course of the year.

43:20 Thank you. That's helpful color there. And then maybe just as my follow-up question, just switching gears to capital allocation here. And maybe as we think about on the M and 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? And would you consider anything larger or transformational? Yes. Thanks, Erin. If we think about acquisitions kind of back into our journey of health, really looking at portfolio expansions, and to 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 Cumberland, Searchlight, some of the assets that we already have in place. So we'll continue to focus on those opportunities on expanding the portfolio.

44:20 And as we think about selective M and A, just as a reminder, we don't have that built into any of our forward looking guidance in terms of their numbers. Selective M and A for us really could kind of anchor back into an opportunity in an institutional space going forward, kind of filling out some of the areas that we don't have coverage in now. By and large, while we're taking a close look at what the opportunities are for selective M and A, we really have our efforts focused on increasing the portfolio basket in those lines of business that are driving higher margins. Cumberlands is a perfect example. We'll continue to work through those targets, and we're quite active in that area right now as we speak. But once again, we'll continue to keep an eye on the market and opportunities that could be accretive down the road from an M and A point of view.

45:11 With respect to your question on transformational M and A, well, that's not in our plan. We maintain a very healthy balance sheet. It gives us the capacity to entertain a number of opportunities to help accelerate our journey of health. We look at that, we certainly have the capacity to do that. We're very disciplined, though, in our approach around M and 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 2.5 times range. Thank you. I'll pass the line.

46:00 Thank you. The next question comes from Gary Ho with Giserings Capital Markets. Please go ahead. Thanks. Good morning and congrats on the quarter and the IPO. So I wanted to kind of go back to the EBITDA margin discussion. So 30.6% this quarter and yet you're targeting 30% range. I think Brian, you alluded to the some of the lumpiness that could happen. So 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 kind of built into that 30%? Yeah. As as we look at our our margins and our our growth from quarter to quarter, it can vary for because of our launch portfolio and competitive circumstances.

46:55 As we look at the first quarter, we did see a lift in the in The US 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 hundred eighty day exclusive product in in The US in 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 our launch calendar. Okay. Great. And then, as my follow-up, just going back to The US tariffs discussion, maybe for Jeff Christine. So I I know it's not policy yet, but I'm guessing you've assessed maybe perhaps some contingency plans, high level, what could those look like, and perhaps talk about how long those plans might take to implement.

47:56 Yeah. I think as it's mentioned, it's early days for us. So we we continue to kind of work closely and and certainly stay in touch with the administration, and I certainly support supportive of of kind of where this the policy will eventually go. I think we feel like we're in a really good position here. We've 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 US market and actually expand on these assets to meet some of their needs. So I think the while we understand the what how this will be be how we'll get after this and how how we'll we'll receive, I guess, further information on how we should be thinking about We will stay closely in tune with it, but we we feel like we're 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.

48:54 So yeah, we're 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 have I I covered think you covered it. I mean, 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 US, in their desire to have protection against a complicated geopolitical supply chain. And 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 US who isn't often for inflation.

49:46 And he announced a tariff that would begin in 'twenty eight. 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 Tanya Guzalves with Canaccord Genuity. Please go ahead. Hi, good morning guys. First question for 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?

50:33 And whether this is we should expect this to be a onetime item or something that might persist through the year? So I would just say this is normal operations, and you will see this ebb and flow over the quarters. We're 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 wouldn't take Q1's results as a signal that anything unusual happened in the quarter. It's really just timing around the business that we operate. Okay. Perfect. And then my follow-up, sticking to the line of question on tariffs.

51:20 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? And has the tariff uncertainty changed either the type of assets you're looking at or the relative attractiveness of U. S. Manufacturing assets? So there's 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 wouldn't say that we've 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.

52:16 But that is probably the only additional real factor that we have. Yeah. I'll just add to Christine's comment around assets as we've, as as mentioned, we feel really well positioned here in North America. But I also wanna just highlight the opportunity with, our our halo asset where we had increased capacity of the sterile line manufacturing. That's a good example where it might not seem like an obvious investment, but it adds critical products in sterile manufacturing into The US, 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, an investment that will start to also meet the needs of the government in increasing products, external manufacturing. So those types of initiatives could be part of how we look at assets as we go forward.

53:08 But as Christine said, 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 and how we look forward how we look into the 2,030 cycles of of developing products and and getting ready to launch products in The US. 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. I'll first question is on portfolio expansion opportunities and M and A. I wonder like as you mentioned that you're quite active in looking for portfolio expansion opportunities.

53:58 And I wonder if you could describe the competitive environment out there and how and how you're seeing pricing, fluctuate perhaps from the time that, you, undertook the Cumberland transaction? And even looking back to the Searchlight transaction, how are how is pricing and competition looking there? And I have a follow-up. Yeah. So we're we're, as I mentioned, we we continue to work here. It really kind of also layers back into our partner of choice as we think about developing our strategy in these portfolios, and this kind of layers into this portfolio expansion. So 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, products into assets that we have that are ongoing and have momentum.

54:52 So the opportunity is very enriched. Really can't speak to any of the dynamics around pricing, but I think we are out there. These conversations have been certainly building momentum for us over the past couple years, not just post IPO. So we've got a pretty good handle on the targets that we're looking at, the opportunities. And as we build out Cumberland, I think about as you think about Cumberland, we just now add more opportunities for partners that we can layer into there. So we're feeling good about it. But once again, when we think about the opportunities here, we are going to maintain a disciplined approach. We're looking for assets that are going to drive margin accretion and our return on invested capital. So we will as we look to build out the portfolio, we'll make sure we stay quite disciplined in executing to developing that margin accretion of 30% and return on invested capital.

55:43 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're able to shed any more light on, on what this is. If we think about Apotex Direct and following 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.

56:34 Great. All right. Thanks, team. I'll pass the line. Thank you. The next question comes from Frederico Gomez with ATB Corp. 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 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 ophthalmology space in The US being disrupted.

57:48 There's a lot of different issues that go on. So 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 conflict in The Middle East. What is your relative exposure there currently within that international segment? And I wonder how much of, I guess, a continued drag is baked into your fiscal year guidance.

58:40 Hi, Frederic. 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, and that started with some logistical considerations around getting our product into that that market. I think we have largely recovered in that space. But as as you can imagine, the demand is lower than it would normally be with less travel and fewer expats in the region region right now. That said, The Middle East as a commercial entity for us is a smaller portion of our business. And as we we we expect to see over time that start to normalize for us, but not have a significant impact on our overall results.

59:34 What we're monitoring more closely is the knock on impact of pricing and just general supply chain around the world as a result of this conflict. And so far, we've 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're watching very closely. But again, to date, haven't really seen a material impact or anything to be concerned about. Thank you. Thank you.

1:00:21 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'll keep, other ANDA filers in Canada permanently off the market? And could they have led to REDI'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 it brings 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, the brands of biosimilars, they do bring, I think, different levels of complexity in the supply chain naturally. So I think having a good understanding of your supply chain, first and foremost, if you haven't had experience as we kind of think about our strategy and contemplating that, 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 that have attached to them, complex supply chains, they do just in and of themselves provide a barrier for competition.

1:01:45 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 of the market, you have to work carefully with your suppliers, but it's important to understand the supply chain, but only that, have suppliers that are willing to grow into that opportunity and demand with you. So 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. And we'll continue to work upstream in our lines of business and 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?

1:02:38 Or did 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, I guess, market segments and product segments where we launch into, companies will have, I guess, best of kind of categories, almost an individual response to it. So we fully anticipate as we launch into markets that we will we 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 some companies will absolutely defend the franchise on their products.

1:03:29 But we're quite comfortable competing in this space, and we're we're trying to anticipate that level of competition and how we'll react to what we see real time in the market as we're trying to get out there and grow 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 300,000,000,000 of branded Rx revenue at risk over the next five years, how should we view the cadence of Apotex new product launches for that opportunity?

1:04:15 And is it tracking to early expectations? Well, I think we have 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 four eighty 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, so 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.

1:05:18 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's 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 in oncology. Is that a continued pursuit? Or are there any strategic shifts to note?

1:06:06 I think the best way to look at that is is by market. If we think of the Canadian market, we are certainly well integrated here with therapeutic areas in place. We think of, you know, our biosimilars looking in ophthalmology, oncology. We go over to Searchlight. We have women's health and derm. So I think if you think about The US market as we're expanding into those therapeutic areas, a good example was just looking at our Cumberland acquisition, which once again gives us opportunities into the institutional space, of looking at acute care, ecology, pain, gastroenterology. The US, we're still, I would say, building out those therapeutic areas and continuing to look at a couple other potential targeted areas, so we'll continue to build into that. Canada, we feel like we're pretty well established. Those assets are in place. And rolling back to some of the previous questions around portfolio expansion, that's where you're really now filling those portfolios into assets that are in place. The U.

1:07:04 S, we're 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 Pareto Capital. Please go ahead. Good 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, you know, any people, any costs associated with that, you know, kind of the first month and a half, of that, acquisition closing?

1:07:53 Yeah. The the transaction closed, the the July 1 as as you noted, and we're very happy with the the transition so far to date. It's still early days, and we're working very hard to unlock the additional value that that we see in that asset. As far as cost? Yeah. There are 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 we're just focusing on giving them the resources that they need to be successful, but don't don't view that as a material integration cost for the company.

1:08:42 That's great. And lastly, on the you know, kind of a lot of discussions on The US policy. How about in 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 can 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.

1:09:31 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 good to hear. Thank you very much. Thank you. Our next and the last question comes from Nate Poe with National Bank of the Capital Markets. Please go ahead. Good. Thank you for taking my question. My first one is related to the Health Canada's Mysterio Reliance order. Can you just give any color on how that might impact the competitive environment and perhaps your product launch timing?

1:10:32 Nate, it's could you repeat the question? You broke up. We got the Health Canada piece. We just didn't hear the whole thing. So 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 you're breaking up when you're saying the order. M r o. MRO. Okay. And do we have your follow-up question, too? And my follow-up question would just be on the tariffs.

1:11:20 From your knowledge, have your conversations thinking on how to address these different from your competitors in any way? So on the referring to the the reliance order, Nate, once again, we we see this opportunity here is is strong for 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. So 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.

1:12:12 And if you think about being a domestic manufacturer, it's a way to really recognise 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 can give us. I think it's just it's good focus for the government to have to be working with industry and local industry in how we are placing investments and having recognition for those investments. Maybe just to add Yeah. This is from the reliance order. So Health Canada will prioritize brands. And at this point in time, generics are not in scope, and that's another signal that Health Canada recognized the importance of favoring local domestic manufacturers. And so at this point in time, the focus is really on brands. And Nate, your ultimate question?

1:13:04 Question, thank you for is on The U. S. Tariffs. Your knowledge or have your conversations or thinking on how to trust them differed from any of your competitors? US tariffs. Yeah. So so I I can't speak to the conversations that that the administration has with our competitors. What I can say is there is a unique rec recognition of Canada as part of a solution. And the fact that we're North American based is very much on a core message associated with the bulk of the administration. So I don't know what's happening in the competitors' conversations.

1:13:50 But obviously, dynamics that are unique to Canada are a good potential advantage for us. All right. Well, thank you, everybody, for joining us today 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 lines.