Mylan Inc (NASDAQ:MYL) Q4 2015 Earnings and Proposed Acquisition of Meda AB Conference Call February 10, 2016 4:30 PM ET
Kris King - Vice President, Global Investor Relations
Heather Bresch - Chief Executive Officer and Executive Director
Rajiv Malik - President and Executive Director
John Sheehan - Executive Vice President and Chief Financial Officer
Anthony Mauro - Chief Commercial Officer
Chris Schott - JPMorgan
Jami Rubin - Goldman Sachs
Ronny Gal - Bernstein
Gregg Gilbert - Deutsche Bank
David Risinger - Morgan Stanley
Douglas Tsao - Barclays
Marc Goodman - UBS
Elliot Wilbur - Raymond James
Andrew Finkelstein - Susquehanna Financial
Tim Chang - BTIG
Good day, ladies and gentlemen, and welcome to Mylan's conference call discussing 2015 earnings and the proposed acquisition of Meda AB. [Operator Instructions] I would now like to introduce your host for today's program, Kris King, Vice President, Global Investor Relations. Please go ahead.
Thank you, Jonathan. Good afternoon, everyone. Welcome to Mylan's conference call discussing our 2015 earnings, 2016 guidance and our proposed acquisition of Meda AB, which I will refer to as the proposed transaction. Joining me for today's call are Mylan's Chief Executive Officer, Heather Bresch; President, Rajiv Malik; Executive Vice President and Chief Financial Officer, John Sheehan; and Chief Commercial Officer, Tony Mauro.
During today's call, we will be making forward-looking statements. Such forward-looking statements may include, without limitation, statements about the proposed transaction, Mylan's related public offer to the shareholders of Meda to acquire all the outstanding shares of Meda which I will refer to as the offer, Mylan's acquisition which I will refer to as the EPD transaction of Mylan, Inc. and Abbott Laboratories' non-U.S. developed market specialty and branded generics business which I will refer to as the EPD business, the benefits and synergies of the proposed transaction and the EPD transaction, future opportunities for Mylan, Meda or the combined company and products, and any other statements regarding Mylan's, Meda's or the combined company's future operations, anticipated business levels, future earnings, planned activities, anticipated growth, market opportunities, strategies, competition and other expectations and targets for future periods.
Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, uncertainties related to the proposed transaction and offer and the consummation thereof; the ability to meet expectations regarding the accounting and tax treatments of the EPD transaction and the proposed transaction; changes in relevant tax and other laws; the integration of Meda and the EPD business being more difficult, time consuming or costly than expected; operating costs, customer loss and business disruption being greater than expected following the proposed transaction and the EPD transaction; the impact of competition situations where we manufacture, market and/or sell products, notwithstanding unresolved allegations of patent infringement; any regulatory, legal or other impediments to our ability to bring new products to market; any changes in our difficulties with our inventory of or ability to manufacture and distribute the EpiPen Auto-Injector to meet anticipated demand; those set forth under the forward-looking statements in today's earnings release; and the risk factors set forth in Mylan N.V.'s Quarterly Reports on Form 10-Q for the periods ended March 31, 2015 and June 30, 2015 as well as our other filings with the SEC.
These risks and uncertainties also include those risks and uncertainties that will be discussed in the offer document to be filed with the Swedish Financial Supervisory Authority, the Registration Statement on Form S-4 to be filed with the SEC, and the EU Prospectus to be filed with the Netherlands Authority for the Financial Markets or another competent EU authority.
Except as required by applicable law, we undertake no obligation to update any statements made today, whether as a result of new information, future events, or otherwise. Today's call should be listened to and considered in its entirety and understood to speak only as of today's date.
In addition, we'll be referring to certain actual and projected financial metrics of Mylan on an adjusted basis, which are non-GAAP financial measures. These non-GAAP measures are presented in order to supplement your understanding and assessment of our financial performance. Please refer to today's earnings release and the presentation used during today's call, both of which will be available on our website as they contain detailed reconciliations of these non-GAAP financial measures to the most directly comparable GAAP financial measures.
Before I turn the call over to Heather, let me also remind you that the material in the call, with the exception of 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'll now turn the call over to Heather.
Thank you, Kris, and good afternoon, everyone. Thanks for joining us. We have a lot of great news to share with you today. We'll be discussing the Meda transaction, reviewing highlights from 2015, and providing guidance for 2016, with or without Meda, given that we expect to close by the end of Q3 this year.
Turning first to the transaction we just announced. We have agreed to acquire Meda, a leading international specialty pharmaceutical company via a recommended public offer and a transaction valued at $9.9 billion. We are receiving, including synergies, approximately $1.1 billion in EBITDA.
In addition to the Meda Board's recommendation, I am pleased that Meda's two largest shareholders, representing approximately 30% of outstanding shares, have irrevocably committed to tender into the offer and intend to remain long-term shareholders of the combined company.
The strategic rationale for a combination of Mylan and Meda has long been very clear. In addition to being partner since 2011 on EpiPen in Europe, we have had numerous discussions over the years about other ways to collaborate, including our proposal to acquire the company in 2014.
Since 2014, the rationale for this combination has only been further enhanced by Meda's acquisitions of Rottapharm and our acquisition of EPD, with the ability to leverage this infrastructure especially in Europe and emerging markets. This combination continues to accelerate the execution of the vision and strategy we laid out over a decade ago.
The global competitiveness of our industry and consolidation of our customer base continues to drive the importance of scale, and this combination creates a global pharmaceutical leader with 2015 combined revenues of $11.8 billion and adjusted EBITDA of $3.8 billion, a portfolio of more than 2,000 products and critical mass across all commercial channels, including a $1 billion OTC business.
By offering one of the industry's broadest portfolios of products across all customer channels, including Rx, Gx, and OTC, we'll be able to mean even more to our customers, which is increasingly important in light of the evolving payer and distributor environment.
Geographically, we're gaining more balanced and expanded global footprint with an even stronger presence across Europe, a leading U.S. specialty business, and an expanded presence in emerging markets, including several new and attractive ones such as China, Southeast Asia, Russia, the Middle East, and Mexico.
Together, we will also become a leader in the global respiratory allergy market and achieve scale in many other therapeutic areas, including dermatology and pain, offering us even greater opportunities for growth in these categories.
As you know, we have always been very active in looking at various opportunities. We revisited the Meda opportunity this past summer and continued conversation throughout the fall. During this time, the fundamentals and the inherent value from this combination become even more apparent, the more we dug into the business during due diligence, leading to our announcement today. This combination will create tremendous value for our shareholders as well as other stakeholders.
On a cash flow basis, at 12.9x 2015 adjusted EBITDA and 8.9x adjusted EBITDA with synergies, we expect to achieve substantial annual operational synergies of approximately $350 million in year four. We believe we are paying an attractive multiple that is in line with market precedence for such scarce, high-quality asset.
The transaction is expected to be immediately accretive to Mylan earnings with accretion increasing significantly after the first full year 2017 as synergies are realized. Most importantly, the transaction creates the opportunity to achieve $0.35 to $0.40 accretion in 2017 and to accelerate achievement of our previously stated $6 adjusted diluted EPS target to 2017 versus 2018.
We expect to see accelerated earnings and EBITDA growth going forward as well as substantial cash flows and enhanced margins. Even with the financial commitment to this transaction, we still have ample financial flexibility for business development activity, for additional share buyback, all while keeping our commitment to investment grade.
Giving our long history together, we know Meda's business, their people, and their culture extremely well. We believe that we will be able to quickly and smoothly integrate this business. I look forward to working with and welcoming Meda's leadership team and talented workforce to our organization. They have built a terrific company, and I believe we will be able to achieve great things together.
With that, let me turn now to the highlights of our performance during 2015. Mylan again had an outstanding year delivering exceptional financial results, while continuing to execute on our long-term growth drivers.
On the topline, we generated adjusted total revenues of approximately $9.4 billion despite considerable FX headwinds, representing a year-over-year constant currency increase of 28%. On the bottomline, adjusted diluted EPS came in at $4.30, a 21% year-over-year increase even after absorbing $0.11 of FX headwind, which put us at the high-end of our guidance range.
We also had a record year with respect to cash. Adjusted free cash flow more than doubled and adjusted free cash flow stood at 87% of adjusted net income. In addition, we closed on two strategic acquisitions during the year. First was Abbott's EPD Business, which has surpassed our growth expectation and has proven to be a solid revenue contributor. Second was the Famy Care transaction through which we are now well on our way to creating a leading women's healthcare franchise.
Also noteworthy during 2015 was the further strengthening of our EpiPen franchise and our continued efforts to increase awareness and expand access to the anaphylaxis market. One point of note, while we saw higher sales of EpiPen due to higher volume that resulted in part from the Auvi-Q recall, we saw the same net payer pricing dynamic that existed throughout 2015, and we don't expect material changes to the environment in 2016.
We also continued to make good progress across our strategic growth drivers. In our respiratory program, we recently announced that we submitted our ANDA for generic Advair. We are extremely excited about this opportunity, and we continue to believe that Mylan will be the first company to bring generic Advair to the U.S. market in 2017.
In building on our successful Biocon partnership, we announced earlier this year an exclusive global agreement with Momenta that expands our portfolio of biologics with up to six additional products and broadens the scope and scale of our capability. The combination of this program and our Biocon partnership positions Mylan as a worldwide leader in the biologics space.
In summary, 2015 underscores the power of the exceptional global platform we serve and our ability to absorb volatility and maximize opportunity. It also reflects the superb execution and teamwork by Mylan's employees around the world, and on behalf of the Board of Directors and our entire leadership team, I'd like to thank them for an outstanding year and a job very well done.
Now, turning to 2016. We look forward to delivering another year of outstanding financial performance. On the topline, we expect growth of approximately 16% compared to 2015 and a guidance range of $10.5 billion to $11.5 billion. On the bottom line, we expect growth of approximately 16% year-over-year with guidance range for adjusted diluted EPS of $4.85 to $5.15.
Our guidance ranges include a quarter's worth of contribution from Meda. However, we are also committed to these ranges without Meda. And as mentioned earlier, we see opportunity to accelerate the achievement of our $6 adjusted diluted EPS target to 2017.
I'd now like to take a minute to thank John, who's retiring from Mylan on April 1, for his service to our company. During his six years with us, John helped shape the company's ongoing transformation into a global leader in healthcare. We are all wishing him the very best with the entrance of new chapter of his life.
Before I turn the call over to Tony, I'd also like to take a moment to congratulate him on being appointed Mylan's Chief Commercial Officer, which became effective earlier this year. Tony has been with the company for nearly 20 years and most recently successfully led our largest commercial business in the North American region for the last four years. In his new role, Tony oversees all of our commercial businesses around the world.
With that, I'll turn the call over to him to discuss the performance of our core business during 2015.
Thank you so much, Heather, and good afternoon, everyone. As mentioned earlier, Mylan had a phenomenal year, with constant currency adjusted total revenues rising 28% compared to 2014, coming from 9% growth in our legacy business and 19% from EPD. All of our regions and businesses contributed to the strong performance.
In our North America generic segment, revenues totaled nearly $4 billion, a 16% increase compared to 2014. Growth came mainly from sales of new products and to a lesser extent from the EPD business. Also contributing were higher volumes on existing products, partially offset by lower pricing.
In Europe, sales totaled $2.2 billion in 2015, a year-over-year constant currency increase of 67%. Growth came primarily from sales generated by EPD and to a lesser extent from new products. Higher volumes on existing products, mainly in France and Italy were offset by lower pricing throughout the region.
In the rest of world, sales totaled $2 billion, a year-over-year increase of 38% constant currency. The growth came from EPD, new product launches in Australia and Japan and higher volumes in India, predominantly of ARVs, and in Brazil. Increases were offset somewhat by lower volumes on existing products in Japan and lower pricing in the region.
Our specialty business delivered revenues of $1.2 billion in 2015, an increase of 1% compared to 2014. In addition to the strong performance of EpiPen, as Heather referenced, sales of Perforomist and ULTIVA increased by double-digit percentage points from the prior year. I would also like to note that our EPD business grew 2% year-over-year, demonstrating again our ability to take a declining business and drive growth ahead of our expectations.
With that, I'll turn the call over to John.
Thanks, Tony. Good afternoon, everyone. As Heather and Tony both mentioned, we're extremely pleased with our financial results for the fourth quarter and full year 2015, highlighted by the strong growth in our generic segment and the exceptional adjusted free cash flow we generated.
Our total revenues for the fourth quarter of 2015 were $2.5 billion, an increase of 24% on a constant currency basis from the prior-year period. Revenues were unfavorably impacted by foreign currency translation by approximately $91 million in the current quarter when compared to the prior-year period.
Adjusted total revenues for 2015 were $9.4 billion, an increase of 28% on a constant currency basis from the prior year, which includes revenues from EPD business of approximately $1.5 billion. Revenues for the full year 2015 were unfavorably impacted by foreign currency translation by approximately $432 million when compared to the prior-year period and more than $300 million compared to the FX rates we used for providing our financial guidance at the beginning of the year.
For the fourth quarter, third-party net sales were positively impacted by the contribution from the acquired EPD business of approximately $456 million, of which approximately $286 million was in Europe and $123 million was in our rest of world region, with the remainder coming from EPD Canada. As a reminder, beginning in 2016, the EPD business and Mylan commercial businesses are operating as one. As such, separate revenue information will no longer be reported.
Adjusted gross margin for the fourth quarter and full year of 2015 was a very strong 56%, up 200 basis points for the quarter and approximately 320 basis points for the full year. Our strong margins are primarily the result of the positive contribution from the acquired EPD business combined with new product introductions.
R&D expense on an adjusted basis was approximately 6% of total revenues for the fourth quarter and approximately 7% of total adjusted revenues for the full year. R&D expense for the quarter and full year increased due to the impact of the acquired EPD business as well as the continued development of our respiratory, insulin and biologics programs. At the same time, SG&A also on an adjusted basis was approximately 20% of total adjusted revenues for the quarter and full year, which includes the impact of the EPD business.
Throughout 2015 we continued to realize additional tax benefits from the EPD transaction, and as a result of our ongoing efforts to optimize our tax structure, we had an adjusted effective tax rate for the full year of approximately 17%. We continue to look at additional tax planning strategies for opportunities to further reduce our annual effective tax rate in 2016 and beyond.
Our fourth quarter adjusted net earnings were $620 million or $1.22 per share, a 16% increase from our Q4 2014 adjusted diluted EPS of $1.05 per share. For the full year 2015, our adjusted net earnings were $2.14 billion or $4.30 per share, a 21% increase from 2014 adjusted diluted EPS of $3.56 and at the high-end of our previously communicated guidance.
It's important to note that U.S. GAAP requires EPS to be calculated for each individual period, based on the average outstanding share count for that period. As a result of the issuance of shares to Abbott in the first quarter of 2015, our adjusted diluted EPS for the calendar year and the sum of the quarters does not add by $0.04 per share.
Our 2015 EPS growth was achieved in spite of unrelenting foreign currency headwinds, which reduced our calendar year adjusted diluted EPS by $0.11 per share versus our guidance rates at the beginning of the year, and by $0.18 per share versus 2014's actual FX rates. Our very strong 2015 adjusted diluted EPS resulted from the strength of our global operating platform, including the acquired EPD business and the organic revenue growth across our legacy generics business.
Turning to our cash flow and liquidity metrics. Adjusted cash provided by operating activities was impressive $2.2 billion for the calendar year, representing an increase of approximately $1 billion from the prior year, which is the result of the growth in the adjusted earnings combined with our ongoing working capital initiatives. Through diligent cash flow management, our adjusted free cash flow totaled $1.9 billion for 2015.
As a result of our strong operating cash flow at the end of the year, our net debt to adjusted EBITDA leverage ratio was less than 2x. We have no amounts outstanding on our $400 million AR facility or our $1.6 billion revolving credit facility, and we have full access to more than $1 billion of cash on our balance sheet.
As we look towards 2016, we remain fully committed to our investment grade credit rating, including after the successful completion of the offer to acquire Meda, and we continued to have ample borrowing capacity and financial flexibility. As a reminder, we have fully committed financing to fund the acquisition of Meda.
To summarize, we finished the year stronger than ever and began 2016 with ample financial flexibility. Our fourth quarter and full year 2015 results were outstanding, as we continue to experience the positive impact of the EPD business combined with the continued organic growth of our legacy business and the strength of our global operating platform.
I'll now turn the call over to Rajiv to review the Meda transaction in more detail.
Thank you, John. At the outset, I would like to echo Heather's sentiments and say that I very much look forward to welcoming and working with Meda's leadership team and workforce. As Heather noted earlier, this transaction suit out to us, because Meda is an extraordinarily attractive strategic fit for Mylan.
We have always been active in evaluating many different strategic opportunities, looking for companies and assets that would compliment our existing strength and capabilities, make our company financially stronger and better position us to achieve our mission, strategy and sustainable growth. This acquisition delivers on all of those categories in a powerful way.
Meda is a highly profitable and durable business, delivering total sales of about $2.3 billion in 2015 and with estimated growth through 2018 of about 3% in revenues and about 5% in adjusted EBITDA. Meda brings us a very attractive portfolio, including about 900 branded OTC and generic products, with strong positions in respiratory, allergy, dermatology, pain and GI. Through this transaction, we are adding nearly 4,500 employees, including Meda's robust sales and marketing organization of more than 2,600 people with strong businesses in Europe, U.S. and exciting businesses in key emerging markets.
Meda also brings a complimentary network of seven manufacturing facilities in Europe, U.S. and India, which further strengthens our operating platform and provides us with nice capabilities in nasals, topicals, liquids and DPIs. While you can see that this is a very attractive asset, this is not just about what Meda is delivering on a standalone basis, but what we can do together. Let's look at that now.
On the next slide, you can begin to see what Mylan and Meda look like on a combined basis, and see how Meda further diversifies and strengthens our business by both geography and by channel. On a 2015 combined basis, we'll go from having two-thirds of our revenues from generics to generics making up just more than half of our business. Combined, our specialty business will represent more than a third of the business and OTC above 10%.
As you can see, the combined company will have a diversified portfolio of more than 2,000 branded OTC and generic products, and the addition of Meda's portfolio expands Mylan's branded and OTC portfolio in all regions. Geographically, we continue to enhance the balance of our business between North America, Europe and emerging markets, with an even larger European business and more diversified emerging markets business. Our continued focus on diversification across portfolio, channel and geography helps to both de-risk our platform and strengthen our ability to capitalize on our high-value future launches.
Turning to the next slide, you can see the diversity of this combined portfolio broken out by the sales contribution of each therapeutic area. To give you a sense of the enhanced scale, we'll have in key therapeutic categories, we expect to have six $1 billion franchises at close, respiratory/allergy, GI, cardio, CNS, diabetes and metabolic and infectious disease.
Further, we will have significantly enhanced our presence in other areas such as dermatology, women's health, anesthesia and pain. We see a great deal of opportunity to begin building total patient and pharmacy solution around these franchises, given the breadth of our presence and ability to meet customer and patient needs.
On this next slide, you can get a sense of this portfolio and pipeline breadth and depth in some of these large strategic therapeutic categories across branded, generic and OTC products. First and foremost is our combined allergy/respiratory franchise, where we see opportunities to really leverage our breadth and scale commercially with products, including EpiPen and Dymista, and position ourselves to maximize upcoming launches such as generic Advair and Revefenacin.
Derm is another exciting opportunity for us and One Mylan has been eager to expand in. As you can see Meda's branded portfolio with market leaders like Elidel, nicely complements Mylan's largely generics portfolio and provides opportunity to enhance our presence in this space across channels. Similarly, in pain, the Meda portfolio is complementary to Mylan's portfolio, which was enhanced significantly through the acquisition of our Abbott EPD business.
As you can see, these are leading durable brands that lie in Mylan's core areas of strategic focus. Meda enhances our already strong expertise and market knowledge in these areas, together we have the platform, capabilities, speed and agility to maximize these portfolios. In addition, the Meda business will benefit from our steadfast dedication to our robust R&D efforts, product innovation and the combined business will be fueled by Mylan's commitment to R&D and expansion of our product portfolio.
Again, this transaction delivers on one of Mylan's key strategic imperative comparatives, expansion in the OTC market, and Meda's strength in this area was an important differentiating factor for us, when evaluating this transaction. Meda has a substantial OTC presence in Europe and emerging markets, and an exciting platform for growth in U.S. This combination instantly creates $1 billion global OTC business and a foundation for further expansion.
I would like to note that Meda's portfolio is not a private label business. It's all branded OTC products, which yield much higher margins and it contains some very well-established and differentiated OTC brands.
We see many opportunities to leverage this OTC portfolio through our combined global platform. And we are confident in our ability to accelerate growth in this business through marketing and line expansions. Further, we see exciting possibilities for future business development and M&A. We'll continue to maintain our strategic and opportunistic approach in this regard.
Turning to the next slide, you can see how Meda will expand Mylan's geographic footprint. Meda provides us with entry into 16 new countries and builds real critical mass, commercially across Europe and emerging markets, while deepening our presence in Americas. The combined company will sell into more than 165 countries around the world with their direct commercial presence in about 60 markets. Our combined sales force will number approximately 5,900 people.
Looking at this map, you can see that we are increasing our sales headcount by about 50% in both Americas and Europe, and nearly doubling in emerging markets. Especially in Europe, we are adding very significantly to our manpower in critical growth markets, giving us a breadth and scale we need to continue building out our portfolio of products and services.
As we look at our enhanced and diversified geographic profile, we also believe we have an opportunity to optimize this infrastructure and accelerate our growth, especially our EPD business and across emerging markets.
On the next slide, you can see another differentiating factor for Mylan, and for the combined business, our unmatched manufacturing and supply chain platform. We are excited to deploy this platform to Meda and see opportunities for efficiencies and integration along the supply chain, providing opportunities for synergies.
With that, I would like to turn it back over to Tony to walk through in greater detail the geographies we are strengthening through this transaction.
Thanks, Rajiv. I too would like to express enthusiasm for welcoming Meda's team to organization, and working alongside them to deliver better heath for a better world. As you have seen this combination creates an even strong commercial platform around the world.
On a next slide, you can see how Meda adds considerable strength and scale to already robust business in Europe. The combined company generated about $3.8 billion in 2015 revenues from Europe, about 60% more than Mylan would have had on a standalone basis. As you know, scale is very important in this reason giving the highly competitive market dynamics.
On the chart on the right, you can see that we have increased scale across each of our key European countries, with significant enhancements through our businesses in Germany, the Nordics, Italy and France among others. Meda's business complements and builds on the strengths of our EPD assets to create a deeper, stronger and more diversified platform across Europe that can further maximize market opportunities and weather challenges.
Meda also provides us with a strong and durable OTC business in Europe, which makes us a leader across all channels. I also note that the transaction consolidates EpiPen for us in Europe. Meda has been marketing this key product for us in the region for several years and we believe that bringing this product into our combined commercial infrastructure with a greater ability to leverage our global expertise in this area will allow us to drive greater performance from this product.
On the next slide, you will get a sense of how this transaction will dramatically accelerate Mylan's growth in emerging markets, while creating a diversified scale of business of $1.5 billion in 2015 pro forma revenues. The 16 new countries we're adding to this transaction are in the emerging market area, with Meda providing us entry into exciting new markets, such as China, Russia, Southeast Asia, the Middle East, Turkey and Mexico.
China has long been an area of interest for us, but we have been very deliberate about how we get into this market. We are pleased that Meda has a strong history in China, having established its business there in 1994 and that it has operated the business as an owned affiliate since 2011.
Importantly, Meda has a direct sales presence in many of these key markets, not relying on a contract sales organization in these important countries. For instance, Meda has reps on the ground in China, Russia and Turkey among other countries. Meda also has done a great job establishing strong brand in these markets. Some of the key ones are listed here and we look forward to leveraging our combined portfolio across the regions.
We see longer-term opportunities to bring Mylan's differentiated portfolio into these new markets, especially in infectious disease, biologics, insulin and women's health. While our presence in many of these markets is still small, it provides an exciting foothold and opportunities to build upon.
On the next slide, we come back to our core mission of providing access to 7 billion people. This combination means we will be better able to serve the evolving needs of our customers across all channels, while being able to offer them a greater diversity of products and by selling One Mylan around the world.
We have already seen the value of our One Mylan approach with EPD and our existing specialty and generic businesses, in terms of being able to leverage our powerful platform to bring more value to our customers through a broader range of products and services, and total patient and pharmacy solutions. Further, by working together across all our channels, we have been able to leverage commercial best practices in customer relationships to deliver more.
Now, John will walk you through the deal structure and resulting financial profile of Mylan.
Thank you, Tony. Let me start by providing a quick overview of the transactions terms. This transaction is structured as a recommended public offer to the shareholders of Meda to tender all of their shares to Mylan. An announcement, the value is equal to a SEK165 for Meda's share, consisting about SEK132 in cash and the remainder in Mylan ordinary shares for a transaction value of approximately $9.9 billion. The Meda Board has recommended the offer and Meda shareholders representing approximately 30% of the outstanding shares has irrevocably committed to accept the offer.
As I mentioned earlier, we expect the transaction will close at the end of the third quarter of 2016, subject to receipt of typical regulatory clearances, acceptance to the offer by more than 90% of Meda's shareholders, and satisfaction of other customary conditions. The offer is not subject to any financing conditions or approval by Mylan shareholders.
As Heather outlined earlier, this transaction provides compelling financial benefits for shareholders and others stakeholders of both companies. As mentioned earlier, we see opportunity to accelerate the achievement of our $6 adjusted diluted EPS target to 2017. We also will complete the integration by the end of year three, realizing the full financial benefit of approximately $350 million in synergies in year four.
As you know, we have a proven track record of achieving our synergy targets, and we are confident that these synergies are highly achievable. As you can see on this next Slide, the transaction will deliver significant accretion with a CAGR from 2015 to 2017 of more than 18%.
Moving to the next slide. The implied multiples for this transaction are in line with relevant market precedents for scale high quality assets like Meda. As you can see, we expect the trailing synergized multiple of 8.9x.
On the following slide, you see just how Mylan will continue to have a very strong financial profile post-transaction, and that we are positioned for continued growth. We expect our pro forma leverage to be approximately 3.8x debt to adjusted EBITDA at transaction close. We also expect, we will maintain our investment-grade credit ratings, which again is an important attribute for any deal we pursue.
As you can see on the chart, we expect debt to adjusted EBITDA of less than 3x by the end of 2017. With our significant pre-cash flows, highly leverageable infrastructure and a competitive global tax structure, we continue to have the financial flexibility to competitively pursue the right additional opportunities as they arise. We intend to continue to serve as a leading consolidator in our industry in a way that meets our mission and business strategy, and continues to deliver value to our shareholders.
I would now like to walk through our financial guidance for 2016 in further detail. At the bottomline, we are projecting adjusted diluted EPS between $4.85 and $5.15 per share, the midpoint of which is an increase of 16% from 2015 adjusted diluted EPS. This EPS guidance range is based on the following income statement line item guidance metrics, all of which are on an adjusted basis with the exception of total revenues.
Total revenues are projected to be between $10.5 billion and $11.5 billion, the midpoint of which is an increase of 16% from 2015 total adjusted revenues. This guidance range includes a quarter's work of contribution from Meda. However, we're also committed to these ranges without Meda. Excluding Meda, our generics business is expected to generate revenue growth of approximately 20% in 2016, while specialty is expected to generate revenue growth of approximately 8%.
Revenues from new business including Meda and EPD for the full year are expected to be between $800 million and $900 million, and the remaining increase in revenue will come equally from increased volumes on existing products and new product launches. Adjusted gross margins will increase again to be between 55% and 57%. Drivers of the increase include new product revenues and the strength of our North American generics business, as we continue to benefit from an improved product mix.
Adjusted SG&A will be between 19% and 20% of total revenues, which includes a full year impact of the EPD business. Adjusted R&D will be between 6% and 7% of total revenues, as we continue to invest in our future biologics, insulin and respiratory programs. Using these guidance metrics, we project adjusted EBITDA of between $3.5 billion and $4 billion. Also, we expect our adjusted tax rate to be in the range of 15% to 17%.
Based upon the 2016 guidance metrics for adjusted operating cash flow of $2.4 billion to $2.6 billion and capital expenditures between $400 million and $500 million, we're projecting adjusted free cash flow in the range of $2 billion to $2.1 billion.
Finally, we are projecting an average diluted share count of between 520 million and 530 million shares, which includes the weighted average shares issued for the acquisition of Meda and the settlement this April of the warrants related to the cash convertibles notes, which were cash settled in 2015.
As this chart demonstrates, our 2016 financial guidance provides significant operating leverage, including increasing adjusted growth and EBITDA margins, and declining adjusted R&D and SG&A as a percent of revenue resulting in our adjusted diluted EPS growth of 16%.
Looking at the bridge to 2016 revenue guidance, revenues from new product launches combined with volume growth and our base service will serve to offset price erosion on existing products. In terms of base pricing assumptions in the generic segment, as we traditionally have, we assume low-to-mid single-digit price erosion.
In specialty, we have assumed high-single digit growth in terms of pricing. We expect revenue from the Meda acquisition to contribute approximately $500 million to $600 million of incremental revenue in 2016. In addition, revenue from new business includes a full year impact of the EPD business. As mentioned previously, our 2016 guidance FX rates do not result in a significant year-over-year foreign currency translation impact on our 2016 revenue guidance range.
This chart provides a projected bridge between our 2015, actual 2015 adjusted diluted EPS of $4.30, and the midpoint of our 2016 guidance range of $5, showing a year-over-year increase of 16%.
New product launches from our legacy business and to a lesser extent margin expansion will drive our earnings growth in 2016. Partially offsetting this earnings growth will be increased investment in R&D spending and higher interest expense largely due to the financing of the Meda acquisition.
From a phasing perspective, we expect the quarterly development of our EPS for 2016 to be similar to 2015 with Q1 being relatively flat to the prior year, Q3 being our highest quarter of the year and followed next by Q4.
That concludes my remarks, and I'll turn the call back over to Heather.
Thank you, John. Well, as promised, we delivered a lot of great news today. And as our track record suggests, we have been consistent in our philosophy of making acquisitions based on the belief that we can do more together than they could do on a standalone basis. Meda is no different, and we believe we can do more with this asset than they could alone, and we see significant opportunities for accelerated growth.
Further, by successfully executing on our vision and strategy for the past decade, we have delivered exceptional results for our shareholders with an earnings CAGR of 26% through 2016. Again, with this Meda transaction, we have the opportunity to accelerate our 2018 earnings target of $6 and adjusted diluted EPS to 2017.
I now look forward to taking your questions. Thank you.
[Operator Instructions] Our first question comes from the line of Chris Schott from JPMorgan.
I guess, just two here. First, what type of organic growth should we expect from the Meda assets over the next few years? I think it's a business where a lot of us are just trying to get their hands around, and just how fast do you think you can grow the topline for these acquired assets?
And the second one is just to elaborate on the price paid here. It does seem like a large premium, particularly in this market. I know it's strategic, I know it brings accretion, but just again, how did get comfortable with this type of price given the current market dynamics out there?
I'll start, and then I'll let Rajiv weigh in a little bit on the business. I think it's important to first point out that we certainly don't make long-term decisions that will create shareholder value on short-term price fluctuations, and I think that certainly there is significant macro-dynamics that play with the market today. I think we see that systemically across, especially the healthcare sector.
And I think that we were fortunate to have a very high-quality process and have the ability to do due diligence, and the more we dug, the more comfortable we are not only with the strategic and the compelling rationale, but as I mentioned, it even then was much more enhanced with their addition of Rottapharm, which we had looked at several years ago and very much liked that asset as well as our Abbott EPD business and how that's going to allow us to really leverage infrastructure in Europe as well as bringing on 16 additional countries, where we'll be able to now have infrastructure to lever the Mylan current portfolio as well as pipeline.
So the strategic and fundamentals of the company have not changed. And when you look at just over the last couple of months like I said, I think it's much more to the macro-dynamics. And we believe the long-term decisions are much more in line when you look at the multiples. They are very much in line for assets such as this scarce high-quality. And so we believe the value really speaks for itself of what we're creating for shareholders and what this combination can do going forward, and like you said, immediately accretive.
And I think, Heather, you answered it all. The other part of the question is not so relevant, they don't stand alone, and a topline is 3% projected growth with the 5% growth on EBITDA. But as Heather mentioned, that's not much relevant, because the pooling effect we see between our Rx, Gx, OTC channels are leveraging this platform from the geographic point of view, exciting opportunities, its presence also on the emerging markets. So we see a lot more to this than just standalone growth of 3%.
And I think just lastly, it's important to note that it's not the trading multiple right now, if I go back to what's happening in the environment, it's the deal transaction multiples, which I think even in times where there is a lot of volatility in the marketplace, you don't really historically see those change to the transaction multiples or translating the transaction multiples.
Our next question comes from the line of Jami Rubin from Goldman Sachs.
Just a follow-up on the question concerning price, Heather. It does seem like a lot of money to pay just to accelerate your earnings growth to $6 by 2017. Can you now update your -- I think you had said before, you expect to do at least $6 by 2018. Now, with Meda in-hand, can you at least sort of update what you expect the earnings progression to look like with this asset in-hand over the next three years, say, out to 2020? That would be helpful.
And also, John or Heather, can you just enlighten us on what exactly happened with EpiPen this quarter? In terms of the pricing dynamics, you had mentioned that you expected those dynamics to continue into 2016, what changed?
So let me start with the $6 being the opportunity to accelerate the $6 into 2017 versus 2018. That by no means -- that's just a beginning of what Meda and Mylan combination will bear. I think importantly, not only does it accelerate near-term accretion and shareholder value, but over the longer-term I think as we've said, the strategic rationale speaks for itself. The complimentary nature of the product portfolio will now have over 2,000 products across multiple geographies, expansion into emerging markets to allow us more leverage.
Our portfolio, when you look over the next 10 years to our biologics, insulin, I mean the opportunities to truly maximize these launches in these territories with this infrastructure is just, in our opinion, going to be unparalleled. I think that Mylan will be positioned as a truly diversified global generic and specialty pharmaceutical company that's able to deliver through our unprecedented global supply chain.
To be able now to apply that, and in addition, to now have the kind of commercial infrastructure and operational infrastructure that will allow us to continue to add on whether it's other dosage forms, we've talked about everything from derm to ophthalmic to new therapeutic category.
So honestly, we just see the $6 in 2017 as the beginning to continuing the growth trajectory that our shareholders have enjoyed over the last 10 years. And certainly, as we close the transaction and we move forward, we will be giving continued guidance and updating the longer-term trajectory. But I can assure you that this platform will continue to deliver as it has in the past.
As far as EpiPen, Jami, I think that I tried throughout 2015, especially in beginning of the year to point out that Mylan have been very proactive in maintaining our market share in a very competitive multi-epinephrine marketplace. And that involve entering contracts with our payers, long-term multi-year contracts.
And I think then when the unprecedented event of Auvi-Q having to do a complete product recall, while we absolutely enjoyed volume increases, and we see obviously that continuing through 2016, what I pointed out is the net price from the payer was mainly what it had been throughout 2015 and we don't see that materially changing.
I mean, I think it's important to remember that we're dealing with a whole portfolio of products with these payers that it's not about any one product. And while we will continue to be opportunistic, I think that as I've said, EpiPen, very important brand for us and brand franchise going forward, that it more and more represents as a much smaller part of Mylan. And certainly, now with the Mylan and Meda combination, again the diversification is taking away from any concentration from any one product.
Our next question comes from the line of Ronny Gal from Bernstein.
I have just two points of puzzle, I mean, I'm sorry I'm kind of trading a little bit on what people have said already. You were saying about $10 billion on Meda and your market cap is about $25 billion today. So you're generating about 10% accretion level. Well, if you've just taken the same amount of money and bought back shares, you would have bought back 40% of your share comp.
So yes, maybe it's not that efficient, but it looks likes there's a huge miss adjustment here between what you can do with the shares, buying back shares, rather what you do with your transactions. So I'm kind of struggling with it, unless you are seeing some fantastic growth going forward for the Meda asset, it's hard for me to see it working.
And then, if you don't mind, I'll sneak in two more. On EpiPen, I distinctly remember conversation with the management team including Robert, when I was told specifically about you guys that now that Auvi-Q is out of the market, you're in a great position to drive a higher net price from EpiPen. So is this -- if you can comment more broadly on what have changed from that perspective?
And last and this is more for Rajiv. Rajiv, you guys kind of mentioned, or Tony, you guys kind of mentioned a beachhead in additional market. I kind of took a look through the Meda statements, presentation for the third quarter, I mean they've got $60 million or so in Mexico, if we just take the third quarter and multiply it by four they've got $30 million Russia. It sounds like all of those businesses are kind of like borderline profitable. Is that enough of a beachhead for you? It sounds like it will take several years before you guys can really turn those business into profitability.
Well, Ronny, you certainly maximize one question. So let me start with the overall, again, coming back to Mylan and our philosophy on uses of capital. I think we've been very clear that we are opportunistic. I think the board is constantly looking at buybacks and everything else in the marketplace.
So with that being said, we've also very much focused on growing topline, as well as bottomline and striking that right balance. So I think when you think over the longer-term and the value to shareholders, there is much more value in continuing to build a sustainable platform that's going to deliver out into perpetuity versus the short-term centric viewpoint of just looking at share buybacks and isolation from any kind of M&A or BB activity.
And I guess, Ronny, I'd also point out, and I'm sure you appreciate that Mylan cannot go out and borrow $10 billion, maintaining it's investment grade credit rating and doing share repurchase program. The $10 billion also comes with all of the EBITDA and earnings that Meda has. So I'm not sure necessarily that there is an apples-to-apples of $10 billion acquisition versus $10 billion of share repurchase, that's not realistic.
And as far as EpiPen is concerned, Ronny, I obviously were in many, if not, all those meetings, I never remember discussing that price. I think what we did say is that we were very proactive, and I had very, I think, very straightforward conversations with all of the investors and shareholders that we were maintaining market share, and to do so that requires aggressive rebating, and that's why, that we absorbed much of that during 2015.
And so when the Auvi-Q recall happened, we absolutely had the opportunity to not only increase our market share and increase volumes, we're continuing to invest to increase the overall market. We still think there is runway room around growing the anaphylaxis market. But nothing has changed. And that's why I wanted to point out that those contracts are in place and we'll continue to, like I said, be opportunistic. But that's on EpiPen, Rajiv?
And on markets, I think I would like to, again, say, it's not about what Meda had done on standalone, but Russia $35 million, for example, or Mexico, these are nice entry points for us to load or download our own portfolio and what we bring, because we have been incubating product portfolio in all of these markets and we were looking forward to create a infrastructure. And we know what we have done with the foothold in Brazil and we are on a nice trajectory over there. So for us these are nice entry points into these markets, which we have been looking forward to build upon.
Our next question comes from the line of Gregg Gilbert from Deutsche Bank.
I have a few, hopefully, quick easy ones. First of all, you've mentioned a couple of times you've submitted generic Advair. Can you comment on whether it's been accepted or not for filing? And secondly, Heather and Tony, any change in pricing dynamics in the U.S. generics market late last year, early this? I know, you're forecasting a similar to how you've done in the past, but any interesting sort of color you can provide on whether things are changing on the margin or not or have changed, that would be helpful.
And lastly, Heather, what are your M&A priorities? I know, we just announced the new deal, but the company has gone to great lengths to talk about continued flexibility. So are we looking to just shop for while, but not buy, what are your priorities over the next six to 12 months on M&A beyond convincing folks that Meda is the right deal?
Gregg, yes, we've submitted generic Advair application towards the end of December and we expect to hear from FDA anytime now.
And as it relates, Gregg, to your question on pricing, we believe that your U.S. generic-based business will continue to be stable for 2016. I think John had articulated low-to-mid single-digit range. And we feel very good about our generics business and the stability of it moving forward.
And as far as M&A is concerned, we absolutely, as I mentioned, still looking at assets out there that would now just even be that much more complementary with the global infrastructure we have. And as I have mentioned, whether it's dosage forms around our dermatology or ophthalmic, and also therapeutic categories, that we still believe we have a great opportunities to build out critical mass now across all these channels, Rx, Gx and OTC.
Our next question comes from the line of David Risinger from Morgan Stanley.
So my question is on EpiPen and then the guidance please. With respect to EpiPen, obviously the sales growth was dramatically below the Rx growth due to pricing. My question is with respect to the contracts that you mentioned, Heather, maybe you could just provide a little bit more color on the length of those?
I'm assuming that you may have contracted more aggressively to potentially blunt the risk of Teva generic EpiPen launch. Just wondering if that is a realistic assumption that I'm making that you were considering that when you priced more aggressively. And then just a quick tidbit of a question, in terms of your $6 number for 2017, does that include an assumed launch of generic Advair?
So I guess let met start with EpiPen. Price volume was no different in Q4 from other quarters of the year. So I'm not quite sure what you're referencing there. As far as the contracts that I mentioned, look we were -- as I mentioned in 2015, the aggressiveness came from the current multi-epinephrine market and the players that were in there including Auvi-Q and Sanofi.
So like I said, we were maintaining market share. And I think where a bit of a disconnect came as that people believe the once Auvi-Q was recalled, that the world would go back to pre there never have been an Auvi-Q in the market. And it's a very unprecedented event that I don't know that really has ever happened before.
And so I think as we look forward, we said we're managing our whole portfolio of products with these payers. The contracts are all different in nature, and so certainly we're not going to comment on any individual contract. I'm just trying to get some flavor to and feeling that EpiPen is an extremely important brand franchise. We think it has great brand equity and it will be an important franchise for us for years to come. It's just more and more represents a much less portion of Mylan's overall business, and especially our now combined Mylan and Meda front.
I think that your other question, David, with respect to 2017, as we've previously indicated, we expect to receive approval for being able to launch generic Advair in 2017, and with all other products we consider the risk weighting of that product and when providing our guidance. So yes, we do expect to launch the product in 2017, and yes, it is on a risk-weighted basis included in the guidance or target -- sorry, I don't want to use the word guidance.
Our next question comes from the line of Douglas Tsao from Barclays.
Just Heather, you've spoken about wanting to be a consolidator in the industry, and we've seen with first Perrigo and then obviously what this deal, the Perrigo offer and then this deal, sort of the moving to OTC. Just curious in terms of how you're defining consolidator? I mean should we be thinking within generics or more broadly outside of generics?
And then just also a couple, another follow-up in terms of the thinking behind the partnership with Momenta, and maybe talk a little bit about what they can provide that you couldn't get from your ongoing partnership with Biocon? And then, just one quick, maybe John, if you can provide some commentary on the trends in EPD versus the third quarter on a constant currency basis, that'd be great?
So let me start with the consolidator. You're absolutely right, we have said that we will continue to be a consolidator in the industry. And look I think that you should consider us as continuing to diversify. I think as we said OTC was an important channel, this certainly puts us a great leap forward and is starting to delve a foundation for OTC, but I think importantly its also diversification around reimbursement.
So as you look at the different models from payers and across the different geographies, that continue diversification amongst channels, amongst geographies and with Rx, Gx and OTC. So again, the beautiful and powerful thing about now this combination is the infrastructure we have in place to truly maximize now products that we can pull-through through any of this channel.
So I think it's extremely exciting and I think it gives us more opportunity to have more accretive, strategic acquisitions to now bolt-on to the platform. I'll let Rajiv comment on Momenta?
On Momenta, I think Biocon is focused on seven to eight programs, which are between now and 2022, and we found Momenta programs, some of those programs, they already initiated some of these products, which are beyond 2022, so we then need to put all our eggs into one basket. It was a product not just focusing our passing with Biocon, but we've been focused on the products, and the pipeline and we found Momenta to be a right partner and able partner in this phase.
And lastly, Doug, on your question, surrounding the EPD business and the revenue of 2% up for the year, I tell you we couldn't be happier with that. You recall that in Abbott's hand the EPD business was declining mid-single digits 4%, 5% per year.
And we had indicated last year when we were acquiring the business that our objective was to get to stabilize, get to sales back to breakeven in terms of maintaining stability, and quite honestly we did that in less than a year, and so at 2% growth year-over-year on a constant currency basis for that business, I think we're very pleased with that.
Yes, in the third quarter we saw year-over-year for that quarter alone 5% growth, but as we've said at that time, one quarter does not make a trend make, and so I think a longer term view here of a full year of positive too is a much better indicator of the strength of that business and what it did for us in our hands this year.
Our next question comes from the line of [ph] Sumit Kulkarni from Bank of America.
First, what are your assumptions on the timing of entry of generics in EpiPen and on the potential re-entry of Sanofi's Auvi-Q Second, could you break down the components of synergies and could you confirm if there are any revenue synergies built into your $6 EPS target? And third for, Rajiv, has your Restasis ANDA being accepted for filing by the FDA?
So as far as EpiPen is considered, we are factoring and are assuming a [ph] BX approval in the second half of the year. Again, I think we've been pretty vocal on the high par that we believe in AB-rated claims. But anyway those are the assumptions that are built into our 2016.
And as far as Auvi-Q again, I think it was an extremely unprecedented action that took place. And all I can say is I think it's unprecedented to try to come back from something like that. But again, I don't want to say for Sanofi, but we certainly haven't heard anything about them contemplating any kind of re-entry. Rajiv you want to head on penetration?
The synergies pretty dominantly are based on the cost structure, the G&As, the sales and marketing as well as the cost of goods. And about your question on the Restasis, yes, we received our acceptance and it's under active review. In fact, we received our acceptance in the middle of 2015.
Our next question comes from the line of Marc Goodman from UBS.
First thing is, Europe just seems a little weak in total, I mean even if you include FX. So I was hoping maybe you could just give us some sense of what happened in some of the countries, some of your key countries? And the U.K., France, Italy, where were you strong, where you weak and just relatively?
And then, I just want to make sure we're clear on the U.S. pricing. Can you just tell us in 2015 for the whole year, where did the base business U.S. pricing come in? Was it flat for the year? Was it in fact low-to-mid single-digit? I think what you were saying is you started the year with '15 guidance of low-to-mid single-digit decline and that's why you're keeping the same guidance for '16. But I'm curious, how did they come in '15? And then just remind us how do they come in '14 for the full year, U.S. base business pricing?
So Rajiv, do you want to take Europe?
So Europe, I think in our key countries, which is Italy -- France, we didn't see in the last quarter a huge growth, but we didn't see any losing of the market share. Italy, we saw some good growth. U.K. was very strong, in fact about 30% growth. So we don't see any weakness in our key European countries per se, and as we said, one quarter doesn't make a trend.
And as far as I guess pricing, the only thing I'll point out, then I can let Tony weigh in, is that I think Marc you know that driving pricing has never been a driver. We've been I think a very responsible generic player with hundreds of products into the market and have shown very responsibly price erosion. We've said it's a very competitive marketplace. There has been opportunities that we've had over the course of time, but certainly never a driver of our generics business whatsoever.
And then I think just to add certainly in 2014 and 2015 the market was relatively flat from a base business perspective. There were moments of opportunity and certainly at the same time a moment of deflationary activity happens everyday in our business. So like I said earlier, I feel very good about where our business is at. I feel it's very stable from an erosive perspective and that's about it.
Our next question comes from the line of Elliot Wilbur from Raymond James.
And congratulations Heather and the team on the Meda deal. I know that's an asset that's been in your sight for a while. And I guess looking at combination of all the pieces, all geographically in terms of assets, where it looks like a very strong transaction for the company. Obviously, there is concerns about price, but I want to focus on another issue and just go back to some of Rajiv's commentary with respect to growth, and make sure that I understand this correctly. So the business basically currently is doing about $2.3 billion and then projected growth is around 3% topline and 5% adjusted EBITDA. I want to confirm those metrics and see whether that adjusted EBITDA growth in fact does include -- if that's a fully synergized growth target?
And then just thinking about those metrics, while the asset is or the purchase is accretive to numbers, and again, strategically it looks very attractive. I mean, it clearly is growth dilutive. So I'm just wondering, how you thought about that concept relative to potential impact on valuation and multiple versus the potential long-term attractiveness of the platform?
Sure. Thank you, Elliot. And first, thank you. I think that your ability to see the strategic compellingness of this transaction, the scarcity of this kind of a high-quality asset, I applaud you for your vision. And what I would say as far as when we think about the value, again, I think it's important to know before -- I'll turn it over to Rajiv to get a little bit more into the business. But I think it's very important to know, again, it's not what Meda is doing on a standalone basis. And the metrics that you quoted is just that Meda on a standalone basis.
I think that what's important is now with the combination of Mylan, what we can do together combining Meda with our platform. Across the board, when you look from an operational and supply chain and commercial, I mean now that expertise and experience across the multiple geographies and including giving us a foothold in the 16 new markets, it truly just becomes a portal for us to leverage every launch, every asset, every acquisition from this point forward that much more.
So truly the long-term value of this is the continuation of what we've done over the last 10 years. And I know that we view the strategic transaction that sometimes in the moment is lost on how we're going to deliver that value, but I think if you look at our 26% CAGR through 2016, it becomes -- hopefully our track record speaks for itself, and it becomes evident that we deliver and do what we say we're going to do, which is be able to continue to maximize these assets, optimize this platform and continue our growth trajectory into the foreseeable future. So again, Elliot, I can't thank you enough. And Rajiv?
Yes, let me reconfirm that the 3% topline growth and 5% adjusted EBITDA growth was on a standalone basis. We also confirm during due diligence that they are key countries like U.S., Germany, Italy, France, Sweden and Spain, all emerging markets especially. And their key products, Dymista, Dona, Betadine, Elidel and ArmoLIPID, all are showing steady growth over the next few years.
Our next question comes from the line of Andrew Finkelstein from Susquehanna Financial.
A couple clarifications on the guidance. When you talk about the ranges being valid with or without Meda, and you gave some quantification of the potential Meda contribution. I mean is the whole range in consideration without Meda or should we think of the top-end as being something that would exclusively be with the deal?
Then on the Momenta collaboration. Could you clarify if the milestones that are going to be paid, I think it's about $100 million this year, are those included in your non-GAAP spending or excluded? And then if we think about the 20 -- if we talk back to the synergies, if we could just go through how those were determined and where there may be opportunities for upside as you get into the combined platform?
Look, I think as far as the guidance ranges question -- regarding the guidance range, that's why obviously we do give a range. And we're committed to those ranges, with or without Meda. I think importantly, to note, we're assuming one quarter contribution. So yes, I would say it's safe to assume that if all those assumptions are accurate and we have a full quarter of contribution that certainly look at the topline of the range. It could be near the top-end of the range. And obviously, from the bottomline, would have that opportunity to be above our midpoint.
But again, I think that since we're only talking about one quarter, we wanted to be clear that we were committed to those ranges. And as I often say, all good things don't happen at the same time in this business, and all bad things don't happen at the same time in that business. And that we have a multiple moving pieces in parts that certainly could have us within that range without Meda. And I think as we have done historically, as the year progresses and as events and things become more certain, we're able to either hone in or adjust or update those ranges and we'll continue to do so.
As far as just, again, I'm going to say overall synergies, and then I'll let John and Rajiv weigh-in more in detail, but I guess I do have to go back and just remind people of the track record. I think we have over-delivered on every synergy target we've ever put out there back, starting with Merck. And so our ability, as I mentioned, not only did we have the opportunity to do due diligence and meetings with the management team, and truly really understand what these platforms could do together. And like I said, I hope our track record speaks for itself on integration and execution.
And I would say that synergies are from combined assets when you bring two assets together. We have a fairly good information about their cost structure, our cost structure. And as I said, these synergies are driven mostly from cost structure, the cost of goods, the G&A, the selling and marketing infrastructure as well as some cross-fertilization.
Do we see upsides? Absolutely. We have not been able to put our arms around that what that number, but we believe that there will be a huge pooling effect, we'll be able to cross-leverage the portfolio, do more with these markets and we'll come back to you as we learn more about the asset.
And then, I'll close with respect to the milestones. Milestones that we have in conjunction with collaboration, such as the one with Momenta, are considered a component of the acquisition cost of the product. And as such are not included in our adjusted income or income statement, but rather are capitalized as part of the cost of the acquisition of the products.
Our final question comes from the line of Tim Chang from BTIG.
Heather, could you talk a little bit about the international opportunity for EpiPen? I mean, I was looking at some of Meda's sales figures and it looks like EpiPen, I mean it's not growing as much as is its -- it doesn't seem like its actually growing. Could you talk about what you guys plan to do with EpiPen outside the U.S. to grow that product?
So Tim I think, look, the opportunity is really more fantastic than as it relates to EpiPen. For us, I would say we're sharing this product between three companies. Pfizer manufactures the product, and then Mylan owns the EpiPen, and then Meda was our partner in Europe. So just the opportunity to contract back down to two, certainly makes the financial dynamics much more attractive.
And obviously, throughout Europe, the certain dynamics around pricing and again being multi-epinephrine marketplaces in many of those countries certainly had made challenges in continuing to grow that product. I think now in our hands, when you look at the infrastructure with the combined Abbott EPD business and now with Meda, we are going to have much further reach and be able to I think even invest in a much different way than Meda as a third-party partner was able to do.
So not only do I see it throughout Europe as an opportunity, but as we continue to look and add enhancements and how we bring EpiPen to the market and various other regions around the world, we do see like I said, a lot of opportunity even outside of Europe with the rest of the world, as we continue to invest around EpiPen and the awareness of anaphylaxis.
Well, thank you everyone. Appreciated all the questions, and look forward to seeing you soon.
End of Q&A
Thank you, ladies and gentlemen, for your participation in today's conference. This does conclude the program. You may now disconnect. Good day.
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