Viatris Inc. (VTRS) Q4 2019 Earnings Report, Transcript and Summary

Good afternoon, my name is Catherine, and I will be your conference operator today. At this time, I would like to welcome everyone to the Mylan Fourth Quarter and Full Year 2019 Earnings Conference Call and Webcast. All participants have been placed on mute to prevent any background noise. After the speakers' remarks there will be a question-and-answer session. [Operator Instructions] Thank you. I will now turn the call over to Melissa Trombetta, Head of Global Investor Relations. Please go ahead.

Thank you, Catherine. Good morning everyone. Welcome to Mylan's fourth quarter 2019 earnings and 2020 guidance conference call. Joining me for today's call are Mylan's Chairman, Robert Coury; Chief Executive Officer, Heather Bresch; President, Rajiv Malik; Chief Commercial Officer, Tony Mauro; and Chief Financial Officer, Ken Parks. During today's call, we will be making forward-looking statements on a number of matters, including our financial guidance for 2020 and the proposed transaction pursuant to which Mylan will combine with Pfizer Upjohn business in a Reverse Morris Trust transaction to create a new company that will be named Viatris. These forward-looking statements are subject to risks and uncertainties that could cause future results or events to differ materially from today's projections. Please refer to the earnings release we furnished to the SEC on Form 8-K earlier today as well as our supplemental earning slides, all of which are posted on our website at investor.mylan.com for a fuller explanation of those risks and uncertainties and the limits applicable to forward-looking statements. Mylan routinely posts information that may be important to investors on this website and we use this website address as a means of disclosing material information to the public in a broad, non-exclusionary manner for purposes of the SEC's regulation fair disclosure. In addition, we will be referencing to certain actual and projected financial metrics of Mylan on an adjusted basis, which are non-GAAP financial measures. We will refer to these measures as adjusted and present them in order to supplement your understanding and assessment of our financial performance. Non-GAAP measures should not be considered a substitute for or superior to financial measures calculated in accordance with GAAP. The most directly comparable GAAP measures as well as reconciliations to the non-GAAP measures to those GAAP measures are available in our third quarter earnings release and supplemental earning slides as well as on our website. Please note that this call relates to Mylan's fourth quarter and full year 2019 earnings and we will be limited in what we can speak about Q&A regarding Viatris as we will not be speaking about Upjohn business. Let me also remind you that the information discussed during this call, except for the participant questions, is the property of Mylan and cannot be recorded or rebroadcast without Mylan's expressed written permission. An archived copy of today's call will be available on our website and will remain available for a limited time. With that, I'd like to turn the call over to Heather.

Thank you Melisa and good afternoon. I’d like to welcome everyone to what we expect will be the last full year earnings call for Mylan as a standalone company. I'll be covering commentary regarding Mylan's Q4 and full year 2019 performance. Rajiv and Ken will provide additional detail about these results, including an update on pre-integration planning, and we'll end our prepared remarks with commentary from our Chairman, Robert J. Coury. However, before we get to results I’d first like to thank those Mylan employees who may be listening for their continued dedication and commitment to the customers and patients we serve. I would also like to welcome any Upjohn employees listening to the call. I want to take a moment to address the very serious matter of the Corona virus. We've been in close contact with our colleagues around the world regarding recent developments and our following government and health organization recommendation. The health and safety of our teams and their families is our priority, and we're supporting those on the ground where possible. Our business exposure in is limited. However, given the global nature of our supply chain operations and businesses, our results could potentially be impacted. The guidance we disclosed does not include any anticipated impact from Corona virus. However, we will continue monitoring the situation very closely from a business perspective. Moving to our results, 2019 was a strong year for Mylan. In the fourth quarter and full year Mylan’s businesses grew across all segments on a constant currency basis. Similar to last quarter, our business transformation work continues to flow through our P&L. As we've previously shared, our transformation work is focused on unlocking latent value within Mylan's organization and delivering economic profit while maintaining our commitment of providing access. We started developing this plan in late 2018 and began implementation in earnest late last year. In the fourth quarter, for example, we identified opportunities to further refine our SG&A and R&D spend, focusing on products that are promotionally responsive as well as higher value portfolio investments. Looking at our full year results, Mylan delivered $11.5 billion in revenue, $1 billion on new product launches and $2.1 billion on adjusted free cash flow. And exceeded our adjusted EPS guidance by $0.12 at the midpoint. These results highlight the durability and stability of the business we’ve created, as well as our ability to withstand negative trends impacting the industry. They also reinforce the strength of our diverse portfolio, geographic reach and global commercial and operational scale, powerful levers that will live on through Viatris. Looking ahead to the full year of 2020, today we also announced guidance ranges for total revenues of $11.5 billion 12.5 billion and adjusted EBITDA of $3.2 billion to $3.9 billion. Although we widen the ranges to take into consideration certain factors. The midpoint of our guidance is in line with what we previously disclosed for 2020 in conjunction with the Upjohn transaction. Additionally, as we have previously stated on a go forward basis, we believe adjusted EBITDA to be the best measure of our company's underlying operational results and true business performance. We're extremely proud of the efforts of our global workforce that enable us to sustain consistent business performance and profitability across all of our segments. While we continue to see unprecedented change in our industry, we believe we are setting a solid foundation to help position Viatris for a strong future. I'll now turn the call over to Rajiv.

Thank you, Heather. And good afternoon everyone. To begin, I would like to take a moment to thank my Mylan colleagues for a strong 2019 performance. As Heather mentioned, this call has a unique [indiscernible] as it represents the last time we expect to report our full year results or Mylan as a standalone company. I'm extremely proud of all that we have accomplished together to build a strong global business we have today. It's because of the hard work of our employees that Mylan is well positioned to combine with Upjohn and start a new course as Viatris. I would also like to welcome my Upjohn colleagues who are listening to today's call. I could not be more excited about the opportunities that lie ahead and the meaningful role we Viatris to play in the future of health care. Our unparallel global reach and supply network will enable us to deliver high quality medicines to more patients all around the world. And we will also leverage our platform for development partners to have ready access to expanded markets to our new and unique global healthcare gateway. Day one is quickly approaching, and I'm pleased to report that we remain on track to close in mid-2020. While Pfizer and Upjohn have been working together to ensure that Upjohn is separated as planned Mylan has been partnering with Pfizer and Upjohn on integration planning with a focus on business continuity for both organizations. To build up on Heather’s comments regarding business transformation, it’s important to understand that our 2020 guidance takes into consideration the company applying an economic profitability lens to how we invest every dollar across the business. Our transformation program is about utilizing a highly disciplined approach to drive strong returns on our investments across all of our businesses. We are also looking at our manufacturing network to further optimize the equation of demand, required capacity and efficiency. This program gives us the right mindset and approach to manage the increasingly volatile and dynamic nature of our business. Turning to 2019 total revenues, we delivered $11.5 billion representing 3% growth on a constant currency basis. These results reflect solid underlying business performance, driven by existing products that generated double-digit growth including Creon, Influvac, Dona, Amitiza and Glatiramer Acetate 40 milligram. We also achieved our target of $1 billion in new product launches, driven by Wixela, Fulphila, and several other new products. Our North America business had total net sales of approximately $4.2 billion, which is a 2% increase from the prior year. The increase was driven by $800 million in new product launches, which were partially offset by lower volume, including business transformation related product rationalization and to a lesser extent, price erosion in our commodity genetics portfolio. In Europe, our net sales totaled approximately $4 billion, representing 2% growth on a constant currency basis. Our key brands such as Creon, DYMISTA and Influvac drove this strong performance. In our Rest of World segment, net sales totaled approximately $3.2 billion, representing an 8% growth on a constant currency basis. This increase was primarily the result of new product launches and increased volumes across the region, including key markets like Japan, Australia, and China. As we look ahead to 2020, we continue to see growth being driven by the complex products, global key brands and biosimilars, which will help offset continued complicated pressures on our commoditized genetics portfolio. Overall, we expect another strong year with approximately $600 million in revenue from new product launches, which will help us offset expected mid single-digit year-over-year price erosion. Let me now walk you through projected year-over-year net sales growth across our three business segments. In our North America business, we expect low single-digit growth, largely driven by YUPELRI, Wixela, Glatiramer Acetate, Fulphila as well as, Ogivri. We are also looking forward to the launch of several new products including the midyear launch of insulin glargine. We expect our Europe business to grow mid to high single-digits. This is largely driven by our key brands such as Creon, Influvac, Amitiza and Brufen. We also continue to see opportunities to expand our biosimilars portfolio, which today includes Ogivri, Hulio as well Fulphila. Moving to the Rest of the World, we expect to grow mid single-digit primarily driven by key brands and biosimilars growth in certain expansion and emerging markets. These drivers will be partially upset by government price starts in Japan and Australia, as well as standards around ARVs. I would now like to share some key pipeline updates. Beginning with insulin glargine, as you know, we have been steadfast in our efforts to bring to the market a more affordable insulin for the millions of people living with diabetes around the world. and opiates Sanofi’s formulation patents have been found to be invalid. This was a form on a P. Sanofi has also sued us on one device patent that we have challenged in an IPR proceedings and it's before the district court. We expect a decision and the IPR proceedings by second quarter and we are awaiting the trial judge to see them. Last week, FDA completed its pre-approval inspection of Biocon's insulin manufacturing facility in Malaysia and issued a Form-083 three observations. Biocon is responding to FDA and are confident in their ability to fully address the observations. We do not believe that the inspection in any way impacts our commercialization plans of insulin glargine in USA. Also our biosimilar to Avastin has been accepted for filing and is under review with FDA. Our user fee goal date is December 27 this year. We also submitted our European application and it's currently in the validation stage with the authorities. Lastly, regarding aspart, we remain on track for our U.S. submission in the next quarter. And EYLEA remains on the track for submission in early 2021. As I mentioned, earlier this year, we initiated work on two new brand opportunities. Starting with MR-107A01, which is being developed as a safe and effective, non-narcotic oral analgesic for the management of moderate to severe pain. The drugs novel formulation is being designed to potentially provide an alternative to opioids and a Phase 2 clinical study is being initiated this year. The other product where we initiated [indiscernible] is known as MR-106A01, it's a novel synthetic antimicrobial peptide that's being developed as a topical product for treatment of wounds including burn wounds. Early clinical studies have demonstrated promising efficacy and safety in the treatment of patients with partial thickness burn wounds. We are preparing to initiate further clinical development this year. Finally, we are pleased to update that the pivotal Phase 3 clinical study of Glatiramer Acetate once a month, was started in October, 2019. This study is assessing the efficacy, safety, tolerability of Glatiramer Acetate administered once a month in the treatment of relapsing, remitting multiple sclerosis. To-date, the study has been initiated in 19 sites and is actively enrolling patients. We look forward to keeping you informed of these development programs. And with that, I’ll turn the call over to Ken.

Thanks Rajiv and good afternoon everyone. I'll take a few minutes to provide an overview of our financial results for the fourth quarter, as well as the full year 2019. Fourth quarter 2019 total revenues of $3.2 billion were 4% higher than the prior year and in line with our expectations. Excluding the negative impact of foreign exchange, constant currency total revenues grew 5%, with growth in all three segments. Rest of World net sales grew 9% followed by Europe and North America, which were up 5% and 3% respectively. The increase was primarily driven by new product sales, including Wixela, partially offset by a decrease in net sales from existing products mainly due to lower pricing across the regions. From a segment profitability standpoint, North America declined 5% in the quarter, excluding costs associated with the Morgantown restructuring and remediation program. This decline reflects contributions from new product sales, partially offset by impacts from lower pricing and volumes on existing products due to changes in the competitive environment. In addition to inventory write-offs related to certain product discontinuations. Europe segment profitability expanded 4% in the quarter, reflecting the favorable impact of new product sales and higher volumes of existing products, along with the favorable comparison from lower restructuring costs in the quarter. Rest of World segment profitability also expanded 4% in the quarter, as a result of the favorable impact of new product sales and higher volumes of existing products. These favorable impacts were partially mitigated by lower gross profit on ARV sales, resulting from higher API input costs. For the quarter, we reported adjusted net earnings of $721 million and adjusted EPS of $1.40, which were both above our internal expectations. The year-over-year increase of 8% and adjusted EPS reflects strong segment performance and to a lesser extent, lower interest expense and a lower effective tax rate partially offset by the unfavorable impacts from foreign exchange. Now for the full year, total revenues of $11.5 billion were 1% higher than the prior year, excluding the negative impact of foreign exchange. Constant currency total revenues grew 3%, with all three segments delivering year-over-year growth. Consistent with our expectations, new product sales for the year were approximately $1 billion with approximately $800 million coming from North America and the remaining amount was balanced between Europe and the Rest of World. This growth was partially mitigated by the decrease in net sales from existing products as a result of lower pricing and volumes. For 2019, our adjusted gross margins were approximately 53% compared to 54% in the prior year. Year-over-year, lower gross profit from sales of existing products was essentially offset by gross margins on new product introductions. Moving on to full year segment profitability, excluding costs associated with the Morgantown restructuring and remediation program, North America adjusted segment profitability expanded 3% in the year. This growth reflects contributions from new product sales, partially offset by impacts from lower volumes and to a lesser extent, pricing on existing products, as well as inventory write-offs related to product discontinuations and higher investments in SG&A. Primarily due to unfavorable impacts from foreign currency translation, Europe segment profitability declined 6% and rest of world declined 5%. In addition, both segments reflect the anticipated higher investments in selling and marketing costs and rest of world segment profitability was further impacted by lower gross profit on ARV sales, resulting from the higher API input costs. Full year adjusted R&D of $516 million was down 9% compared to 2018, due to the reprioritization of global programs. In 2019, adjusted SG&A increased 4% compared to the full year 2018, reflecting the expected incremental investments in selling and marketing. In addition, the prior year included the favorable impact of reversing certain performance based incentive accruals. These increases in costs were partially offset by benefits from restructuring activities, as well as business transformation initiatives. We reported adjusted net earnings of $2.28 billion and adjusted EPS of $4.42 for the full year, which was above the high end of our most recent guidance. Excluding the unfavorable impacts from foreign exchange, full year adjusted EPS was flat to 2018. Adjusted free cash flow for the year was exactly in line with our expectations at $2.1 billion, including the planned investment of more than $600 million in networking capital that was required to support the approximately $1 billion of new product launches that we've talked about. Ongoing working capital velocity initiatives and lower capital expenditures, partially offset these investments. During 2019, we delivered on our commitment to repay $1.1 billion of debt, bringing our debt to adjusted EBITDA leverage ratio down to 3.6 times at the end of the fourth quarter, which is in compliance with our covenant requirements and reflects our continuing commitment to our investment grade credit rating. Now moving onto 2020, at a high level for Mylan's standalone, we expect total revenues to be in the range of $11.5 billion to $12.5 billion, which represents an increase of 4% at the mid-point versus full year 2019. As Heather mentioned, going forward, we're no longer providing adjusted EPS guidance, as we believe adjusted EBITDA better reflects how we manage and measure the performance of the business. We expect full year adjusted EBITDA to be in the range of $3.2 billion to $3.9 billion. It's important to note that there are no material changes in our underlying Mylan's standalone business assumptions compared to the Mylan financial targets that were provided in July 2019, when we announced the Upjohn transaction. Our current expectations do reflect the impact of foreign exchange headwinds experienced as we move through 2019, which resulted in the $250 million reduction in the revenue midpoint and the $50 million reduction in the EBITDA midpoint. A schedule reconciling these numbers is included in the press release. As you heard from Rajiv and our top line outlook, we expect positive volume growth along with the contributions from new product launches to more than offset competitive market dynamics. Moving to adjusted EBITDA, we're expecting a positive contribution from sales growth, driven by volume from existing products and new product launches partially offset by pricing, in addition to higher SG&A spending to support those top line expectations and higher R&D investments to focus on our complex product pipeline, which will support the long-term health of our business. Moving to capital deployment, on a standalone basis, our priority remains deleveraging. We intend to repay approximately $1 billion of debt in 2020 on consistent adjusted free cash flow generation. We remain fully committed to our investment grade credit rating and to further reducing leverage as we work towards our standalone long-term average debt to adjusted EBITDA leverage ratio target of approximately 3.0 times. Finally, we anticipate lower interest expense, reflecting the $1.1 billion of debt repayments we made in 2019, as well as the incremental debt repayments we expect to make in 2020. In addition, we expect our adjusted effective tax rate to be between 18% and 19% and we expect the diluted share count of between 516 million and 520 million shares. Before I close, a quick comment on calendarization as you think about modeling the year. We expect total revenues and adjusted EBITDA quarterly phasing to be very consistent with 2019, with Q1 being the lowest quarter and sequentially increasing as we move through the year. First quarter 2019 adjusted EBITDA represented approximately 20% of full year adjusted EBITDA. We expect the same in 2020. In addition, we expect adjusted SG&A as a percentage of revenue for the first half of 2020 to be slightly higher than the second half, due primarily to the calendarization of revenues. Similar to 2019, first quarter 2020 adjusted free cash flow is anticipated to be the lightest quarter of the year, as we invest in the working capital required to support new product launches. But as Rajiv noted, new product launch revenues in 2020 are expected to be approximately $600 million or $400 million lower than 2019. Therefore, we expect a lower front end networking capital investment, which will ultimately put less pressure on first quarter free cash flow. With that, I'd like to turn the call over to Mylan's Chairman, Robert Coury. Rob?

Thank you, Ken. Good afternoon, everyone. To echo the comments of our management team, I too would like to personally thank our dedicated Mylan colleagues for their continued outstanding execution and commitment. And so once again, welcome the Upjohn colleagues as well, who will be partnering with us as we transition into Viatris in the near future. I would also like to share how much our hearts go out to those impacted in China and across the world, in light of the current coronavirus situation. We will continue to do all that we can do to help mitigate the serious health issue. As for the potential company impact and as Heather has mentioned, we like others are closely monitoring the situation. Though, it is too early to predict any commercial impact to our operations around the globe. I’m pleased to share that we have already achieved numerous milestones on our path to create Viatris, the combination of Mylan and Upjohn, a new champion for global health. As you saw this morning in our press release, we have now announced the remaining members of the Viatris board of directors with these appointments at the Viatris board level, we have assembled a world-class board of directors with extensive experience, knowledge and strategic vision to help guide the company and to unlock greater shareholder value. In addition, this morning, we announced Upjohn's CFO, Sanjeev Narula, who will become Viatris’ CFO and will join Michael and Rajiv on the management team. Sanjeev brings exactly the right profile given where the new company will be in its first business lifecycle upon closing. I've had the privilege to spend a great deal of time directly with Sanjeev over the past several months. His strength and operations and his understanding of the pharmaceutical industry as well as the Upjohn will prove to be invaluable. His deep-rooted experience at Pfizer, which includes significant accomplishments in the process optimization and automation, capital allocation, internal and external reporting makes him the right fit to help ensure Viatris’ delivers on its opportunities and commitment to creating shareholder value. Additionally, his significant knowledge of Pfizer and Upjohn will be extremely instrumental as we continue to integrate our two companies and manage the numerous business critical transition service agreements we will have with Pfizer in the early years of Viatris. We are fortunate to add him to the seasoned management team. In other milestones, we have received regulatory approvals in certain key regions, including approval from the state administration for market regulation in China and we recently set the extraordinary general meeting of our shareholders to be held on April 27. In short, we continue to progress every day and remain on track to close the transaction in mid-2020. Our goal remains to build a new and even more robust in integrated global healthcare platform. One that will be balanced between returning capital to shareholders and investing more in innovative segments of the industry’s value chain, while maintaining our core commitment to improve patient access to medicines around the world. With this, as our focus and together with strong and consistent execution and delivering results, I continue to be very excited about the incredible value creation opportunity we expect for shareholders as a result of this combination. To be clear, Viatris will not be a Mylan 2.0. This is Viatris 1.0, which will benefit from the many additional opportunities, not present within either Mylan or Upjohn on a standalone basis. As we continue to progress towards closing and the years beyond, I have been well aware of all of your continued interest in receiving more clarity on what are the – what actually is the starting baseline financial targets for Viatris’ first full year of operations in 2021. As I shared in the last quarter conference call and at the JPMorgan Conference, I believe I have been very consistent and my focus for Viatris in 2021, its first full year of operations. We expect that the formal guidance will be delivered to you by Viatris’ new management team, led by Michael, Rajiv and Sanjeev at the closed and at the appropriate time after the transaction closes. You can expect that the management team will of course, be taken into consideration all the known as well as potentially anticipated headwinds, whether it’s the changes in China’s healthcare system, which some are calling the China reset, the upcoming Lyrica and Celebrex, loss of exclusivity in Japan and any other what-ifs at that time. Simply put, we should expect that the Viatris management team to deliver a 2021 baseline representing a trough year, from which the company can grow from. Looking ahead beyond that, Viatris will be creating a new global and unique global healthcare gateway, which will offer many other biotech and spec pharma companies, ready access to markets around the globe by leveraging our true one-of-a-kind global infrastructure, making Viatris the true partner of choice for players often facing challenges and utilizing multiple, local or regional partners. We envisioned Viatris’ unique global healthcare gateway department to leverage our already existing enhanced scientific successes to-date with our own research and development capabilities, as well as those future opportunities we expect to realize from the Viatris’ global healthcare gateway partnering opportunities to more rapidly broaden our own product portfolio and future pipeline including new business models, so once again, give the street confidence and Viatris’ ability to grow. These are just a few of the additional growth opportunities not present within again, either Mylan or Upjohn on a standalone basis. I would like to conclude by sharing what I mentioned at the JPMorgan Conference last month. We believe that Viatris with its new and unique profile, we’ll be recognized for being at the forefront of establishing a new kind of global pharmaceutical player, designed for where the healthcare industry is going, not where it has been. And I’m extremely excited about the opportunities to have for the company and the value opportunities to Viatris, can’t create for its patients, employees, customers, shareholders and all stakeholders. With that, I will now turn the call over to the operator to start the Q&A session. Thank you.

[Operator Instructions] Your first question comes from the line of Chris Schott with JPMorgan.

Hey, guys. thanks for the questions here. Just maybe, a two-part one here; first, on the 2020 EBITDA guidance for Mylan standalone, just a little bit more color in terms of why we’re seeing a wire range to that EBITDA guidance. Is there less visibility on the business than there was a few months ago or maybe, just give us a little bit more color on what the swing factors are that could leave us at either the high-end or low-end of that range? And then a second question, Robert, you talked about 2021 being kind of a trough year for the company and baseline to grow off of. When you think about that comment, is that referring to EBITDA, is that referring to sales, or is that referring to both sales and EBITDA, just trying to get a sense of, as we think about that year – when you define trough, what are we thinking about there? Thanks so much.

Yes. So, Chris, thanks for the question. EBITDA range, so we clearly provided a set of numbers in July that had a midpoint on the EBITDA of about $3.6 billion. We moved through our second half of the year that our full budget analysis we are – we have made no changes to that midpoint other than the impact of FX, but as you would expect to when we start a year in a very dynamic industry that has a lot of moving parts. We start the year like we did last year with a wider range that we fully intend to narrow around that midpoint just as we did in 2019. So, there’s no subtle message or inherent message about widening the range. Other than that, we’re starting the year when we fully anticipate, to keep that number that we showed you as the midpoint right in our focus.

And Chris, thanks for the question. I would say that I’m mainly talking about revenue and EBITDA. Yes, certainly focusing on the maintaining of the high EBITDA margins that we have. We’re going to spend an awful lot of time and I’m very, very anxious to get to this close, so that management really has the opportunity to not just look at 2021, but look actually beyond that to ensure that 2021 truly is the trough year. You only have one time to reset. This is our opportunity to reset. And we, at the board level, want to absolutely make sure that management’s starting point has the best chance, not just to meet, but even to exceed. So that will be the focus that we have. And management, as I said, will come forth at the proper time to actually give you the actual guidance.

Your next question comes from the line of Randall Stanicky with RBC Capital Markets.

Sounds great. Thank you. Rob, given that 2021 is a trough year, there’s been a lot of focus from investors around what Viatris is going to be able to grow at off of that trough year. We know the Mylan business, it’s backed by pipeline. We understand that. As you think about the Upjohn and the branded business going forward, how do we think about that growth? I mean, obviously, there’s some geographic opportunity, there’s some beat business development. Can you just touch on, are you going to build out a branded R&D capability and how should we think about you investing behind that part of the business and how do we think about that growth off 2021? Thanks.

Thanks, Randall. And I really think directionally, you have been doing a really good job in TeleGraphit. I think the trajectory of, where Viatris will – where it’ll be situated, when it starts and the opportunities going forward. So, I do appreciate the opportunity for me to embellish. I do think that the – there will be opportunities for revenue, the starting point of revenue. I think that whatever that starting point of revenue is some of you have directionally already picked up that the EBITDA, we have many levers to, I think, maintain a strong EBITDA base. I – we do intend on resetting the revenue base, and I do believe that there will be an opportunity to grow. I expect that management, I would like at the very minimum for them to be able to provide a three to five-year CAGR both on top-line and on EBITDA. And I think that we’ll be able to deliver that in terms of what the trough year is over the three to five-year timeframe. And then I do believe again, something, I think you’ve been at front, this creation of this new global healthcare gateway, I have to tell you, this has been in the works since 2016 for us. And the only reason why we didn’t announce this before, I mean obviously, if you saw what we were tied up with in 2016 with the whole EpiPen situation. And I think the street really, really missed the opportunity in 2018, because we were drownded out by all the noise, but it was the best year of science in Mylan’s almost 60-year history. And as you can see, not only did we continue – not only did we build the robust pipeline, but even some of the commentary that Rajiv made today, the three opportunities that we have in our pipeline. The reason why we couldn’t fit – you actually announced the global healthcare gateway that’s been underway since 2016 is because without the Upjohn business and without really having critical mass in China, you really can’t make that claim. We were simply dabbling in China, but Upjohn gave us the critical mass. So, we will be building out an official department that’ll actually be in charge. It’ll be – that department will be led by the new CEO, Michael Goettler. He will be driving that global healthcare gateway and I believe that all future capital allocation and all the disciplines that need to be around future capital allocations will be within that global healthcare gateway. You can fully expect that our internal R&D business development will be in very, very much competition of capital going forward against continuing debt repayment or share buyback or any other opportunities that we would have. But I do think that we have a number of levers and I’m really excited once we get to close this and really, establish to the department of global healthcare gateway, I do think that we will be recognized as partner of choice and represent a real unique opportunity to bring ready access to other spec pharma companies to bring their products around the globe.

Your next question comes from the line of Umer Raffat with Evercore.

Hi, thanks so much for taking my question. Robert, I know the word trough for 2021’s come up a few times. As I think through the possible levers on top-line into next year, it’s not very hard to get to a top-line number for the pro forma company that might be around $18 billion or so. So, am I on the wrong track there? And also if we were to end up in a scenario like that, do you think the cost levers can help you deliver the same EBITDA as you initially announced at the time of the transaction. Thank you very much.

Well, I want to be careful Umer, because I also think you were a leader out in front, doing a lot of work, extensive work. I think you are directionally, absolutely. I think you’ve been probably directionally most correct quite frankly. And again, I don’t – it’s not that I’m given guidance here. I do think that there’ll be adjustments on both revenue and EBITDA, but less on EBITDA, because of what you said, because of the – let’s not forget the billion dollars of synergies. Let’s not forget about the transformational work that’s being done. Let’s not forget about some of the other opportunities that we see and we’re currently even – I know Michael and Sanjeev were doing work on their side, trying to identify some of the transformational opportunities even within Upjohn. So, I think that you’re not actually off track. I think you’ve been kind of spot on. And I think that’s the way others directionally should be looking at it. I think you, Randall, Chris, there’s been several analysts that I think have now been trying to understand 2021, and I want to make sure it’s a trough year. That’s why I think we need to go out to 2022 and we don’t want to say it’s a trough year and then set the numbers in a way, where there’s an another step down. We’ve seen others do that in the sector and we saw the punishment that they had to pay as a result of it. So again, you only get one time to reset. I want to bring as much clarity as we can or have management bring as much clarity as they can and at the proper time, when they give the guidance, I’m sure there’ll be a lot of discussion with the new reset of 2021 will mean and the growth opportunity from there going forward.

Your next question comes from the line of Greg Gilbert with SunTrust.

Yes. thanks. Ken, I was hoping you could comment on free cash flow outlook for 2020 and whether or not it includes any benefits from the new restructuring program and then I was hoping and Rajiv, I could ask you about biosimilars. What have you learned in recent times about what happens to net price in the biosimilars space as additional entrance launch as compared to what has occurred in the past with the small molecules and how would you characterize your early biosimilars pipeline? Are you working on products that for which markets won’t form for biosimilars until five or 10 years from now? Maybe, some color just on how early you’re going in terms of playing offense on biosimilars. Thanks.

So, Greg, I’ll start with the free cash flow question. In the prepared comments, as we talked about 2020 while we’re giving you guidance on EBITDA specifically, I also specifically mentioned, and it’s worth reiterating that we think that 2020 free cash flow will be relatively consistent with what you saw and what we experienced and generated in 2019. Many of the drivers within that are, we’re starting to see some of the benefits from the transformation initiatives, but I would also point out just like we pointed it out for 2019 as well as 2018 that we continue to work on working capital velocity improvement initiatives. We’ve reduced our day’s working capital by probably six or seven days over the last couple of years. Each day is about $40 million at Mylan. And so you can imagine each day that we’re able to organize the business around reducing that working capital requirement gives us another dollar, or in this case, $40 million per day to invest in the business and redeploy the capital appropriately. So, the simple answer is effectively the same cash generation in 2020 supporting the new product, new product launches, but always focusing heavily on working capital improvements.

So, Greg, I’m going to give you a little bit about the pipeline of biosimilars and Tony will embellish youon the market dynamics with me. Biosimilars will continue to be one of the road travelers as we go along and transition into Viatris. So now, you are aware of our existing pipeline, whether it’s EYLEA or at Spark, as follow-on to insulin. You are aware of our finding and use – our goal date out of December 27 for Avastin. But beyond that, we are looking; we also have for Europe rituximab and Enbrel biosimilars, which will be most likely getting to the market in this year. and further to that, if you recall, we had our partnership with Momenta, which was midway dissolved, but there are molecules like Orencia, Prolia and Stelara. We have some of – those programs are in very early stage, but we also extended our Biocon relationship to include Perjeta as well as Toujeo. And we – you can – we rest assure we continue to look far more opportunities around this and share with you as we go along. Tony?

Thanks, Rajiv and Greg, maybe, just touching upon your question around biosimilars and that pricing. I would say each market has their own unique capabilities. Certainly, there’s markets that are focused on tenders, others that require physician generated demand. It really comes down to the cost to develop the services required from a patient perspective and the hybrid approach from physician detailing to working with hospitals and pharmacies that really generate, I think that best mix and I’m very excited about the biosimilars we have in our portfolio today and certainly, the pipeline that we’ve outlined for the future as well.

Your next question comes from the line of Jason Gerberry with BoA.

Hi, thanks for taking my questions. So, I was hoping you can comment on your supply chain and contingency measures in the event, I guess, because the coronavirus leads to production, I guess slowdowns in China. So, what proportion of your API and key starting materials are sourced from China? If you think about issues that could emerge if there is a prolonged work impact there, is it more about rise of API costs that you get hurt by or is it potentially your contracts with distributors where there could be failure to supply penalties or do those contracts give you some flexibility in crisis situations like such? Thanks.

Thanks, Jason. I’ll just start off. obviously, as I think the impact of this virus is changing by the day. I mean our first and foremost consideration right now is just the toll on human life and having a global workforce as we do. We’re trying to take any precautions and as I said in my script, follow the World Health Organization’s recommendation. So, kind of first and foremost, given where we are at this moment and what we know that’s been where our emphasis has been. But as we said, we’re certainly watching and monitoring the business aspects of such. And so Rajiv, do you want to?

Look, from supply chain point of view, I think the whole industry is in one way or other way connected with China, but you would expect us to be much better place, because of our backward integration and very diversified supply chain, when I say diversified, let’s look into our top 20, 25 products, which we are not relying on China at all. But when it comes to our API, we have not only backward integration, but we have also some alternative arrangements. But we can't say – I think if I look forward, I don't see any impact in the very near future. But if this situation persists and continues for another few months, there can be impact. More I'm concerned from a drug shortage point of view, not much from the pricing point of view.

I think the only thing I would add, Jason, this is Rob, is I don't think, because I've read some reports where some analysts may think this affects certain companies more than others. I have to tell you, in our industry, I don't believe that's the case, because – because we do both API and because we do rely on intermediates, all API, all API producers rely on intermediates. All in a lot – I mean, I think it's well-known that most of the intermediates do come from China. So all API suppliers are going to be affected, not just Mylan. We've been fortunate to vertically integrate and have a lot of our own API. But we still need to get the intermediates. And even some of the API that we have, we may sell some to third party. We buy some from third party. So because the entire spec and generic industry is kind of, sort of connected, so to speak, when it comes to the API of intermediates, I think whatever impact there is going to be – it's going to be a broad impact and not particularly any one company or the other.

Your next question comes from the line of Ronny Gal with Bernstein.

Congratulations on the fine quarter, and thank you for the time taking the question. I'd like to, if you don't mind, try to stick two here. One of them, you've mentioned the intermediates for manufacturing. And you also mentioned that you had an increase in factor costs going into your HIV products. I was wondering if you can tell us more broadly? Are we seeing an intermediate price increase? Will this impact the generic industry in 2020 given at least concerns about product shortage? Are you factoring that in? Is that one of the arguments for broadening the range of EBITDA? And second, on biosimilars. Rajiv, if I look at the biosimilar adoptions of late engine products, they actually look quite low for all the companies that enter kind of like second wave. You have a couple of products which are entering second wave or supply coming online after the market have already formed. Is your impression that in the biosimilar markets, you can catch up? Or are we really in a market, which is somewhat similar to the generic market in years back? The earlier players are inherently going to capture the vast majority of the profit pool.

Okay. So let me just start with, I think, the first API question, the intermediate question. I don't believe, at this point of sale, we can – we see any more inflation from the pricing point of view, that there will be, at this point of sale, and I'm going to say that when Robert talked about intermediate. We were fortunate to backward integrate to a lot of extent, even from our intermediate. So over the last three, four years, looking into the volatility of supply from China we focused on delisting their supply and create alternatives. So even kind of – what I will tell you, still a couple of intermediates, we’re still relying heavily in China. But so far, we are not seeing issue from the pricing point of view. We are seeing logistical issues. We're not seeing a disruption from them not being able to produce. So putting that sorry, you want to go?

I think, Rajiv, the only thing I would add, Ronny, I would like to tell you that before this whole coronavirus situation, we have experienced significant increases in some of our API costs last year. And actually, quite frankly, probably within the last 1.5 years to two years. So we have already experienced price increases. As Rajiv mentioned, I think there should be a bigger concern on shortages rather than pricing.

Yes. And so I think we are – first of all, from a supply point of view, our major concern is, from supply point of view that when we reach that point, when there might be a disruption. But we are still, amongst all other players, we are still much better backward integrated and have our own other options. Now coming to the biosimilars, you're right. But here I would like Tony to add up if he wants to add up anything. I don't think that if you are not in the first or second – first wave, it should be an issue. And you saw, a good example is on Fulphila, where we had some supply constraints. We launched ahead and you [indiscernible] caught up pretty well. So – and now, and but it does take time just by the – because of the unique nature of this business and the channel. So we are very optimistic that once we have – 2019 was a year for us to fix the portfolio from a supply perspective, which we had fixed now. And now we'll go and fix our – get the customers or market share which we need. Tony?

Yes, maybe just to add quickly. I think, once again, depending on the market, certainly, the tender market, you have equal opportunity to compete regardless of the wave. And in markets like the U.S., in particular, in the oncology space, there are reimbursement mechanisms that actually can help the new entrant to the market. So I think as Rajiv outlined, 2019 was a year about very focused, very surgical approach to these customers. 2020 is a year of expansion in our business, in these products in all these markets. So I do think you have an opportunity to play no matter where you're at.

Your next question comes from the line of David Risinger with Morgan Stanley.

Yes. Thank you very much. So I just wanted to ask a high-level question first, Robert, about the evolution of generic markets in Europe and emerging markets in Asia. So over time, it seems like generics evolve from branded to then branded generic and then ultimately, generic. Could you speak to how you see Mylan's opportunity to capitalize on that trend longer-term, given the footprint that Upjohn has, particularly in emerging markets in Asia? And then second, just a very minor question, which is management had talked about the opportunity to move biosimilar BOTOX forward. I think that the comment was on the third quarter call that if you move it forward, it could be something that you could commercialize by 2025. Could you just give us an update on your development plans there? Thank you.

Why don't you take BOTOX first, and then I'll hit the second one.

So, David, thank you. For BOTOX, if you recall, we had told you that we had a meeting with the FDA last year, which you confirmed a biosimilar pathway to be a viable pathway. And we have data – we have a deadline of April 30 to basically extend our relationship with everyone. Even today, we are working with them very closely to evaluate some more data so that we can be very sure that we have a viable product. If that – if we go ahead, yes, we'll be able to launch it before 2025.

And David, I think you actually have a really good question at a high level. And I think you're spot on in the natural progression, especially started in Europe, where you had brand, which they call ethical drugs and then brand generic and then generic. But what I – and so we've discovered this and have been operating in that environment, with all three. And of course, we also discover the importance of OTC, which we added that on. Because each one of these markets, David, are actually driven by a different priority scheme. Some markets are actually driven by generics. Some markets are actually still driven by brand, and most markets accept brand generics. And believe it or not, OTC has its advantages just because of the relationship that the OTC rep has with pharmacies, it’s a little bit different than when you're regulated both either in the brand or the generics. So I will tell you in Europe, there is actually still quite a bit of, especially central and Eastern Europe. I wouldn't say that generics has taken the kind of hold yet that we believe that it will eventually take. But it's that learning that we have and what we've lived in Europe and where I think you're insightful is that when you think about what Upjohn's bringing to the table, they have yet to experience, quite frankly, what it's like to go from a brand – maybe brand generics, but certainly not generic. So I think the skill set that we're going to be bringing them to the emerging market opportunities that we have, I think that will be one of the upside synergy values that I expect that we're going to gain when we bring the two organizations together. Rajiv, do you want to add something?

Especially from a margin markets point of view, most of the emerging markets are branded generics market are not generic generics markets. And that's where the infrastructure Upjohn will further get us in these markets will help us get more market share and critical mass in these markets. What Upjohn doesn’t bring is what Mylan will provide is the portfolio. We already have significant portfolio and a pipeline, which can be dropped in this market and Upjohn will provide us that extended sales force and commercial infrastructure.

But I think – I think, Rajiv also, it should be noted. There is – honestly, there is a real different skill set between a brand rep and a generic rep and I have to tell you, one the brand rep it's just a different mindset; that generic rep a little bit more scrappy, quick on her feet, dealing with a very volatile, highly competitive environment. It's really the mixture of both of them dependent upon what markets we're operating in that we intend on pulling the strength from both. And as Rajiv mentioned we're really looking forward to the skill set of the Upjohn reps in some of those markets that we just didn't have presence. And if we had to build that presence, it would've taken us time and that's what I meant by the Upjohn transaction never changed the trajectory of our strategy, it’s simply accelerated it at least by three to five years.

Operator?

Your last question comes from the line of Elliot Wilbur with Raymond James.

Thanks. Good afternoon. Just switching gears and going back to performance expectations for the Mylan stand-alone business. Just wondering if you could provide a little bit of color/commentary on expected margin trends in each of your reportable segments, North America, Europe, rest of world, I would presume that given you're expecting top line growth in each of those should be reasonable to assume margin expansion as well on a segment basis, but not certain of that necessarily in the North American segment. I guess given the importance of some of the partnered products to new product revenue expectations in 2020. So just maybe a little bit of commentary on expected margin performance in each of those segments? Thank you.

Sure. Elli, thanks for the question. Look, I think I'll start this also and take you back to the fact that you'll see in the press release that we've included some discussion that's not in any way intended to be new discussion. But for the last 12 months to 18 months we've been talking about the fact that we're really looking at the right – trying to find the right measure that we can talk to you about that is consistent with how we talk about the business internally. And that's why we're moving to an EBITDA measure and it gives you some of the background for that. In doing so what I also want to point out is that comes out a lot of the transformation work that we've been doing over the last year plus, and when I give you a little bit of color about that transformation work, it will help you to understand why we're maybe not giving as much specificity around gross margins versus SG&A rates, because in that transformation work, we're really looking at economic profit on each one of our products, in all the segments and all the businesses and all the markets around the world. And in doing so, as you can imagine, each product has a different gross margin profile depending on the nature, you just heard the discussion on the previous question around how the product is either marketed or represented or how much support it have to have for it, whether it be from a salesperson or from a tendering process. It may have a different SG&A rate but what we're really trying to look at, as we're trying to look at the bottom line, operating margin, EBITDA profitability on each one of these products. Now that said, I will tell you that we don't anticipate significant movements in our gross margin rate from 2019 to 2020 or significant movements in our SG&A rate from 2019 to 2020. But we want to transition and help you transition to thinking about the business, the way that we think about it which is bottom-line operating profitability on each one of the products that are in our portfolio, because that's how we're making decisions around the business today.

Right. Before we close the line I just like to say one thing. A lot of shareholders have been requesting time with Michael and now obviously going to be with Sanjiv, and I can't express, you know, how excited and anxious we are to put Michael and Rajiv and Sanjiv in front of all of you. I would only simply ask for your patience because we are dealing within a highly complex integration. I just like to remind you that Pfizer was right in the midst of separating this business. They were probably only about 25% or 30% into their separation and when Mylan came along. So when you're doing a transaction like this, it's not a typical merger. This is a reverse Moore's trust where you do have three parties here. So there is the amount of work that is being done and why it's taken a little bit longer than maybe a typical transaction, it’s extensive, and I can't even begin to tell you daily, weekly, weekends, the amount of time that people are putting into make sure that we are in a readiness mode from day one. Now with that said I will tell you that if you'll just be patient, we will have Michael, Sanjiv and Rajiv get around to shareholders more for – not for really anything else, but a meet and greet. I would say a get to know I'm anxious to have them meet together with all the analysts, with some of the shareholders. I think that would be a proper, especially even before they come and even give the guidance so that you kind of get to know the individuals. I think we have a really good team. I have to tell you, it's taken some time to really pull together and coalesce this management team. They are tight, they are aligned, I think that they get stronger by the day, by the week and again, I just ask, I want to acknowledge your desire, but I would ask for your patience and we will get around to you as quickly as we possibly can. Thank you.

This does conclude today's Mylan fourth quarter and full year 2019 earnings call and webcast. Please disconnect your lines at this time and have a wonderful day.