Viatris Inc. (VTRS) Q3 2014 Earnings Report, Transcript and Summary

Good day, ladies and gentlemen, and welcome to the Mylan, Inc. Third Quarter Earnings Call. [Operator Instructions] As a reminder, this conference call is being recorded. I would now like to turn the call over to Kris King, Vice President of Investor Relations. You may begin.

Thank you, Destiny. Good afternoon, everyone. Welcome to Mylan's Third Quarter 2014 Earnings Call. Joining me for today's call are Mylan's Chief Executive Officer, Heather Bresch; President, Rajiv Malik; and Executive Vice President and Chief Financial Officer, John Sheehan. During today's call, we will be making forward-looking statements pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Such statements relate to, among other matters, the proposed acquisition by Mylan of Abbott Laboratories' non-U.S. developed markets specialty and branded generics business; our expected or targeted future financials and operating performance; results metrics and plans and expectations related thereto; the ability to obtain regulatory approvals and planned launches of and anticipated exclusivity periods for new products. Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such statements. Factors that could cause or contribute to such differences include, but are not limited to, the timing, accounting and tax treatment of the proposed acquisition; conditions to the completion of the proposed acquisition, including the receipt of approval of Mylan's shareholders; the regulatory approvals required for the proposed acquisition; the integration of Abbott's non-U.S. developed markets specialty and branded generics business by Mylan, being more difficult, time-consuming or costly than expected; operating cost, customer loss and business disruptions being greater than expected following the proposed acquisition; the impact of competition, situations where we manufacture, market and/or sell, notwithstanding unresolved allegations of patent infringement; any regulatory, legal or other impediments to our ability to bring new products to market; those set forth under forward-looking statements in today's earnings release and the risk factors set forth in our Form 10-K for the period ended December 31, 2013, as updated by our Form 8-K filed on August 6, 2014, and Form 10-Q for the period ended June 30, 2014. 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 will 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, which is available on our website as well as the SEC website, as it contains detailed reconciliations of these non-GAAP financial measures to the most directly comparable GAAP financial measure. 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 later today and will remain available for a reasonable amount of time. With that, I'll now turn the call over to Heather.

Thank you, Kris, and good afternoon, everyone, and thank you for joining us today. Mylan had an exceptional third quarter, helping to fuel what is turning out to be yet another outstanding year for the company. All of our regions and businesses experienced year-over-year growth, which is a testament to what makes Mylan truly unique, including our tremendous diversity of our portfolio, our global supply chain, which we leverage to reliably serve our customers, and our proven ability to swiftly execute to take advantage of opportunities whenever and wherever they present themselves. These qualities allow us to continue to shape the company's destiny and to withstand challenges, such as the regulatory ones which we have been experiencing in the U.S., where the FDA continues to struggle to implement GDUFA and has simply been unable to perform efficiently as it transforms. While we find the resulting lack of transparency and timeliness of approvals frustrating, we continue to benefit from our ability to successfully leverage our global network to fill supply gaps resulting from market disruption. And that's why we remain focused on continuing to do what we do best, which is controlling what we can control and leveraging our global operating platform to continue delivering strong performance. Turning to the quarter. Our adjusted diluted EPS increased 41% to $1.16, and revenue increased 18% to nearly $2.1 billion. This outstanding performance was driven, as I mentioned, by our continued ability to leverage our global platform. Our earnings also benefited from an agreement with Strides for compensation for lost revenues in 2014, resulting from supply disruptions that resulted from ongoing quality enhancement activities initiated at certain Agila manufacturing facilities prior to our acquisition of Agila in 2013. During the quarter, our Generics segment delivered revenues of $1.61 billion, an increase of 15% as compared to the third quarter of 2013. In North America, sales totaled $842 million, up 20% year-over-year. This impressive performance was the result of launching new products and capitalizing quickly on unanticipated market opportunities. Again, a tribute to the quality and scale of our network. I'd also note that our Institutional business delivered exceptional revenue growth year-over-year due in part to new product launches and sales related to our Agila business. In Europe, sales totaled $352 million, a slight increase as compared to the third quarter of 2013. The growth was driven by higher volumes in Italy and France and new product launches throughout the region, and we achieved it despite lower pricing throughout Europe. We maintained strong positions in the market, and because generic utilization continues to rise, we continue to view the region as a long-term contributor to our growth, all of which only underscores the strategic rationale behind the Abbott transaction, where we look forward to leveraging their physician channel and our pharmacist channel to build upon our strong position throughout Europe. In our Rest of World region. Sales totaled $414 million, a year-over-year increase of 19%. This very strong growth was driven by our India business, particularly our ARV franchise whose products serve approximately 40% of people being treated for HIV/AIDS in the developing world. In addition, sales in Australia rose as a result of new product launches. I also would note that our business in Brazil is gaining traction, and we are excited about opportunities we are incubating in the country. Our Specialty segment totaled $462 million, an almost 30% increase compared to the third quarter of last year. This very impressive performance was driven by higher EpiPen sales, a significant portion of which was due to volume growth as both EpiPen and the epinephrine auto-injector market expanded at a double-digit rate. We maintain our leadership position and continue to expect EpiPen to become, this year, our first billion-dollar product. As for our outlook for the rest of 2014, we are increasing our guidance range for adjusted diluted EPS to $3.54 to $3.60. We look forward to discussing our impressive growth story when we provide detailed 2015 guidance in conjunction with our fourth quarter earnings. With respect to Abbott, we remain extremely excited about this acquisition and continue to view it as the right next strategic transaction for Mylan as it builds on our strong vertically integrated platform, expands and further diversifies our business and maximizes our ability to execute on our growth drivers. We expect the transaction to be immediately and significantly accretive. And as noted in our 8-K filing last week, we expect the amendment to our agreement to enhance the accretion. We continue to expect the transaction to close during the first quarter of 2015. This transaction also will further enhance our financial flexibility, opening up even more opportunities for us to create additional value for shareholders. We continue to actively pursue opportunities and we are eager to put this enhanced financial flexibility and capital structure to use. Finally, we continue to see potential to accelerate achievement of our 2018 adjusted diluted EPS target of at least $6. Before turning the call over to Rajiv, I'd like, on behalf of Mylan's board and our entire management team, to thank our employees around the world for their loyalty, dedication and hard work. Thank you. With that, Rajiv?

Thank you, Heather, and good afternoon, everyone. As Heather noted, this quarter again demonstrates the diversity of our global business and the breadth and depth of our global portfolio. FDA's implementation of GDUFA has provided both challenges and opportunities for us. We did not receive a number of key approvals that we had anticipated, most notably, Copaxone and Lidoderm. However, on the flip side, we have seen our competitors experience the same and have seen opportunities as a result. Further, GDUFA also has resulted in supply chain disruptions at certain of our competitors, and Mylan has always been well positioned to maximize the opportunities that have presented themselves. This has underscored the importance of having an integrated quality global supply chain as well as the value of our commitment to one global quality center across our network. We also have seen additional opportunities arise as the result of global consolidation among our customers. As to Copaxone, we continue to be engaged with the FDA on our application. As we told you last quarter, we have responded to all FDA requests to date in terms of our ANDA, and we remain confident that we are well positioned to receive approval for our application. On the Copaxone litigation front, we appreciated the opportunity to present our arguments to the U.S. Supreme Court a few weeks ago and remain confident in our position. We look forward to receiving the court's decision. We also announced that our ANDA for a generic version of 3-times-per-week Copaxone 40-milligram per ml has been accepted for filing by FDA. We believe we are one of the first companies to have filed a substantially complete ANDA containing a Paragraph IV certification, and we expect to be eligible for 180 days of marketing exclusivity in the U.S. upon final FDA approval. Now let me provide an update on some of our other key growth drivers. As you have seen, we have initiated a Phase III clinical trial for our generic version of Advair. The trial will evaluate the influence of our product to Advair when administered by inhalation in adult asthma patients. We continue to believe that Mylan will be the first to bring to market an AB-rated substitutable generic form of Advair. We continue to seek additional opportunities to build on our respiratory franchise. We also initiated a Phase III clinical trial to compare the efficacy and safety of Mylan's insulin glargine with that of Lantus in both type 1 and type 2 diabetes patients. We expect to be one of the first to bring to market an interchangeable insulin analog to Lantus. While the science for both these products is complex, building commercial scale manufacturing assets is equally challenging and complex, and we have made significant progress in commissioning these manufacturing facilities. The introduction of such complex products, in addition to the hundreds of others in our pipeline, will continue to diversify our portfolio and further differentiate Mylan with our customers. With regards to our injectables franchise. We are bringing to reality the benefits that we had anticipated from the Agila transaction. We are very pleased with the contributions from Agila this quarter, particularly to our North American and Rest of the World businesses, and we remain excited about the outlook for this important business. On the regulatory front, our quality team has continued to make progress in implementing Mylan's one quality standard across Agila. We continue to work diligently with FDA on our remediation efforts and we anticipate putting these issues behind us soon. Turning now to our ARV franchise. Over the years, we have invested significantly in our product portfolio and supply chain. And today, our entire portfolio is vertically integrated. During this quarter, we further strengthened our leadership position in ARVs in developing markets with a number of recent product approvals under PEPFAR, including nevirapine extended-release and 2 taste-masked pediatric formulations of Abacavir and Lamivudine. We are also building out our ARV franchise in developed markets such as the U.S. and Europe. In the U.S., we recently launched Lamivudine and Zidovudine tablets, and this week, we launched nevirapine extended-release tablets. We also continue to expand our product portfolio around the world through various business development activities focusing on key markets and product franchises. Notably, we announced the acquisition of U.S. rights to Arixtra injection and authorized generic of Arixtra from Aspen. The addition of Arixtra is an attractive opportunity to broaden the range of therapeutic categories we market in the U.S. and further adding to our growing portfolio of complex injectables to better meet our customer needs. We expect to see sustainable value from this product. We also announced our latest agreement with Gilead. The agreement provides nonexclusive rights to manufacture and distribute Sofosbuvir marketed by Gilead as Sovaldi in low-income countries where Mylan is building on a successful base of fighting HIV to now reach millions of people living with hepatitis C. Mylan and Gilead are also working towards concluding additional agreements in the fourth quarter, including an exclusive distribution agreement for Sovaldi brand in India, which will be an important expansion of our commercial operation in that market. With regards to our pending acquisition of Abbott's non-U.S. developed markets specialty and branded generic business, we are making good progress in our pre-integration planning. We are very excited about the talent pool and assets we are gaining through this transaction and the enhanced potential of this business in Mylan hands. We also see this transaction as another opportunity to mean even more to our customers. We eagerly anticipate closing this transaction so that we can begin to realize the significant value we see from this combination. Let me now turn the call over to John. Thanks.

Thanks, Rajiv. Good afternoon, everyone. Today, I'm going to be referring to financial metrics that have been prepared on an adjusted basis. These are non-GAAP financial measures. I refer you back to Kris' comments at the beginning of today's call regarding our use of adjusted measures. I'd like to begin today by walking you through our third quarter financial results, which were at the high end of the increased guidance range that we announced at the beginning of October. These results represented yet another strong quarter for our company with contributions from all regions. With our revised guidance for the calendar year, which we issued this afternoon, we expect that we will achieve the full year results, even without the anticipated 2014 launches of generic Copaxone and generic Lidoderm, which is a testament to the strength and diversity of our world-class platform. Now let me turn to our third quarter financial performance. Starting at the top of our income statement, total revenues for the quarter were $2.1 billion, an increase of approximately 18% when compared to revenues of $1.8 billion in the prior year. For the full year, we expect that our total revenues for 2014 will be in the range of $7.7 billion to $7.8 billion as compared to our guidance from earlier this year of $7.8 billion to $8 billion. The revision of revenue guidance results from delays in key product approvals and the unfavorable impact of changes in foreign exchange rates. We estimate the negative impact foreign exchange rates will have on 2014 revenues is nearly $150 million. Looking at our operating profitability measures. Adjusted gross margin in the third quarter of '14 -- 2014 was a very strong 54%, up over 300 basis points from the same prior year period. Our strong margins are primarily the result of new product introductions in North America and the growth in sales of the EpiPen Auto-Injector. We've increased and narrowed our full year 2014 adjusted gross margin guidance range to between 52% and 53%. Adjusted operating income was $659 million for the third quarter of 2014, an increase of $198 million. The increase in adjusted operating income is primarily the result of the strong gross margins we experienced throughout 2014. In addition, during the current quarter, we recognized a gain of $80 million as a result of an agreement with Strides Arcolab to settle a component of the contingent consideration related to the Agila acquisition. We've included the gain within adjusted operating income due to the lost injectables revenues we experienced in 2014, combined with the corresponding positive impact on our cash balances. Our 2014 injectable revenues have been negatively impacted as a result of supply disruptions due to the ongoing quality enhancement activities initiated at certain Agila facilities prior to our ownership. We look forward to the completion of these activities, along with the continued growth of our global injectables platform. R&D expense on an adjusted basis was $157 million for the third quarter or almost 8% of total revenues and at the upper end of our guidance range. As I indicated earlier in the year, we expected R&D spending to increase throughout 2014 as we continued to invest in our biologics and respiratory programs. Our guidance range for adjusted R&D expense for the full year remains between 7% and 8% of total revenues. At the same time, SG&A, also on an adjusted basis, was $396 million or 19% of total revenues for the third quarter. We continue to expect to be within our adjusted SG&A guidance range of 18% to 20% of total revenues for 2014. Factors contributing to the increase in SG&A include our continued investment in the EpiPen Auto-Injector, including our direct-to-consumer marketing campaign, along with investments in infrastructure to support the growth of the company. Additionally, to support anticipated new launches within North America, we've experienced increased legal and marketing cost during 2014. Adjusted EBITDA for the 3 months ended September 30 was $736 million, an increase of 38% when compared to the prior year. We expect adjusted EBITDA to be between $2.35 billion and $2.4 billion for the full year. Adjusted interest expense for the third quarter of 2014 was $63 million. While adjusted interest expense increased slightly when compared to the prior year quarter and year-to-date periods, our total debt outstanding is up $1.4 billion over the prior period. We continue to benefit from low short-term interest rates as the average rate on all of our outstanding borrowings was slightly below 4%. Additionally, to further enhance our capital structure, we have announced our intention to redeem our 2018 senior notes this November. I'd also like to mention that during the third quarter -- over the third quarter of 2014, we received approval from the regulatory authorities in India to legally merge our Agila Indian subsidiaries into Mylan Labs Limited. The merger resulted in the recognition of a tax benefit of approximately $150 million as the goodwill from the Agila acquisition will now be deductible for tax purposes in India. The impacts of recognizing the tax benefit are excluded from our adjusted results for the quarter. However, we have incorporated future tax deductions into the long-term tax rate projections and have narrowed our 2014 adjusted tax rate guidance to 24% to 25%. Third quarter adjusted net income was $463 million or $1.16 per share, an increase of 43% from our Q3 2013 adjusted net income of $324 million or $0.82 per share. We expect our Q4 adjusted EPS of between $1.03 and $1.09, implying a full year adjusted EPS range of $3.54 to $3.60. The increase in Q4 adjusted EPS when compared to the prior year is the result of new product introductions during 2014 in North America, continued growth in the Specialty segment and to a lesser extent, growth generated from our business development activities. Although we continue to look forward to and expect FDA approval of generic Copaxone and generic Lidoderm, the fourth quarter guidance range excludes the potential launches of these products. Turning to our cash flow and liquidity metrics. Year-to-date, cash flow from operations on an adjusted basis was $1 billion, which is up 42% from our 2013 comparative amount of $727 million. We are narrowing our full year 2000 (sic) [ 2014 ] adjusted operating cash flow target to $1.2 billion to $1.3 billion. Capital expenditures for the 9 months ended September 30, 2014, was $220 million as we continue to invest in our strategic growth drivers. And we expect full year capital expenditures to be within a range of $300 million to $350 million. At the end of the quarter, our debt-to-EBITDA leverage ratio is approximately 3:1. We continue to have ample borrowing capacity and financial flexibility and remain committed to our stated M&A parameters, that any transaction be accretive to earnings and maintain our long-term gross leverage targets at investment grade levels. As previously mentioned, our financial flexibility will be significantly enhanced through the pending Abbott transaction. To summarize, our third quarter was outstanding and provides another example of the strength and diversity of Mylan. We look forward to a strong finish to 2014 and the completion of our transaction with Abbott in early 2015. Before I conclude my remarks, I'd like to briefly update you on the recent amendment that we entered into with Abbott. As you know by now, the amendment, which is contemplated by our transaction agreement, defines the terms under the product supply arrangements that we will enter into as part of the transaction. The amendment will also increase the number of shares that we will issue to Abbott to 110 million shares, valued at approximately $5.5 billion based upon our recent share price range. As a result of the amendment, the multiples at which we are acquiring the business have declined slightly. For example, the adjusted EBITDA multiple, including cumulative operational efficiencies of $200 million, declined from 6.6x to 6.4x. Finally, in conjunction with our fourth quarter call, we will provide detailed 2015 financial guidance that will reflect recent developments and our most up-to-date outlook. That concludes my remarks. And I'll turn the call over to the operator for Q&A. Destiny?

[Operator Instructions] Our first question comes from Ronny Gal of Bernstein. Aaron Gal - Sanford C. Bernstein & Co., LLC., Research Division: A few questions. The first one is on Abbott, first. I don't think you -- I might have missed it, but can you just remind us if you will be able to do the tax inversion through this transaction now that you know the details? And just the big-picture question about this transaction is, I guess, the concern that investors have raised to me was, "Look, this might be a great strategy in the next couple of years. But afterwards, Mylan will have a fairly large business unit which is saddled with declining assets. And when interests go up and you can no longer grow this asset through acquisition, Mylan will not be able to grow." So if you can just perhaps give us a little bit more perspective on your vision. It will be appreciated. And the same questions around insulin. Rajiv, you kind of brought it up, so I've got to ask. Have you gotten guidance from the FDA about interchangeability of insulin? Do you know what you need to do? And does the current set of trials that you're conducting enable you to ask the FDA for an interchangeable label to your insulin?

Okay. So I'll take your first couple and then I'll let Rajiv speak to insulin. So Ronny, yes, we do believe that our Abbott transaction will be a successful inversion. And as far as the business, the strategic rationale, I -- as we look at what Abbott -- so first of all, strategically, we believe that being able to have critical mass now around the physician channel throughout Europe, combined with our retail channel, certainly will give very positive upside synergies about how we're able to make 1 plus 1 equal 4 and how we can serve that market. As you know, it doubles our size in our top 10 markets outside of the United States. So first and foremost, that strategic rationale, I think, is very sound. So what we've said, because of the truly enhanced financial -- the significant financial flexibility we will receive because of the -- because of what Abbott, the cash flows that we'll generate, that we will be adding immediately. In fact -- and I'd called out in my remarks that we are actively -- currently actively pursuing many opportunities. So we are certainly putting it to work immediately and certainly, continue to put it to work after the Abbott transaction closes so that we can take that financial flexibility and continue to complement then this platform across the globe with other high-growth areas.

And Ronny, as regarding insulin. As you will recall, insulin -- -- Lantus was approved as an NDA and not as biologic. So our discussion with the FDA around 505(b)(2) route with interchangeability is a theme so far. So every discussion around this protocol has been around this theme, and our clinical program, which we have agreed with the FDA, is around this theme.

[Operator Instructions] Our next question comes from Douglas Tsao of Barclays.

Just to perhaps touch on a little bit your thinking in terms of executing another strategic deal. I mean, this has obviously been something that's been featured in each of your earnings releases over the last couple of quarters, your sort of willingness and readiness. Is this something that we should anticipate by year-end? Or is it that you're still just not going to do something just to do something and you're looking for the right opportunity? And the direction, are you thinking Generics or Specialty?

Sure. Like I said, we are actively, aggressively pursuing many things. But to your point, we have remained consistent that we wouldn't just add or do a transaction for the sake of doing a transaction. But the good news is there's plenty of transactions out there that do make strategic and financial sense. So we have not certainly put out a time frame other than to say we will -- I think you've seen us in action before, and we are able to move swiftly. And when we find the right target, we certainly act upon it. So I would say that as from a timing perspective, just know that we're out there actively looking at a lot of things. As far as Specialty versus Generic, again, we really are looking across this platform and thinking more about franchises. So -- and as you think about versus -- a generic versus a brand, when you look at how complementary some of our therapeutic categories are, whether allergy, respiratory, you look at everything from a generic Advair to Perforomist, to having nebulization expertise. So I would say, again, we are looking at how we can best complement, either critical mass or add to from a therapeutic category. And that's why, again, having -- after being able to close on the Abbott transaction, being able to leverage these multiple different channels, whether they're physician or retail, it really lets us maximize a portfolio across these channels versus just thinking of something on a product-by-product basis, whether that's a brand product or a generic product. So it's about really leveraging our entire portfolio within these channels that I think gives Mylan the unique opportunity to be very differentiated across the pharmaceutical sector across the globe.

[Operator Instructions] Our next question comes from Jami Rubin of Goldman Sachs.

John, a question for you on the Abbott transaction. Just wondering if we should anticipate any changes to your future projections as a result of the treasury notice. Specifically, I'm referring to the elimination of hopscotching, decontrolling, et cetera. Will that impact your expectations for what the tax rate might look like going forward? And also, do you see any risk of future changes imposed to the newly inverted companies such as earnings stripping? What's your comfort level that, that doesn't change?

So Jami, with respect to the first part of the question on the taxes, we'll be filing our S-4 here in the next week, as early as the next week. And I think that there will be more disclosure around the whole tax and tax inversion as part of that. But we do still, as Heather indicated, just a little bit in response to the first question, we do still to see ourselves having a successful inversion and with the tax rate projections that we talked about in July. And quite honestly, as to where tax reform or changes to tax may go, quite honestly, I'm not going to speculate in that area to the second part of your question.

Our next question comes from Elliot Wilbur of Needham & Company. Elliot Wilbur - Needham & Company, LLC, Research Division: First question for Heather. Your 2 biggest competitors in the U.S., at least with respect to their European businesses, have talked about scaling back sales growth in exchange for profitability or more profitable growth. And maybe that's a function of the fact that the same guy is making the decision of both companies, but just wondering sort of how you're thinking about that with regard to your European platform, anticipating making any changes along similar lines? And then the second question is can you just maybe elaborate a little bit more on the $80 million payment related to Strides? I'm just trying to figure out if this is sort of reimbursement for direct costs incurred in addition to lost sales? Or whether or not there's also inabilities incorporated in there? I'm just trying to figure out sort of what the P&L risk going forward, may be. I think there was originally $250 million held back. I mean, are you protected only up to the $250 million? Or are there additional protections built in if in fact issues such as inabilities continue to arise?

Okay. Thanks, Elliot. Look, as far as Europe -- as it relates to Europe, I would -- if you remember, I think now going back several years ago, that was our answer when Europe -- when the economic kind of crisis and crash came and that ability to be managing our profitability. Because as you know, going back then when we had acquired Merck, 70% -- 75% of their portfolio was in licensed. And so they didn't really -- that -- they didn't have as much control over their own destiny from a supply chain perspective. As we then brought in Merck, as you know, one of our priorities was converting and flipping that, that at least 75% of what we sold we would manufacture. So as we were going through that transition, I remember saying to the market when we were experiencing declining growth in Europe, that we were very much being mindful in managing that profitability. And I think that what we're enjoying today is that discipline that we applied in getting our global supply chain where it is today of truly across the globe manufacturing 80% of what we sell. And we're benefiting, quite honestly, in Europe. We did show year-over-year growth. Yes, we have volume offsetting -- continued price cuts but I think that our ability to control that global supply chain and our ability to have truly this vertical integrated network gives us a lot of flexibility, a lot of room for continued growth, and that's why we see it continuing to be a longer-term growth driver. And now when you couple that with, like I said, what the Abbott platform brings us, we really believe that 1 plus 1 equals 4. So I think that we took those steps several years ago, and it is in allowing not only us to have profitability today, but growth year-over-year, and we see that continuing. And I'll let John and Rajiv hit the Agila.

Yes, so Elliot, with respect to the Strides compensation. That was for revenues that we were unable to realize here in 2014 as a result of the ongoing remediation activities at the Agila facilities and the lack of product as a result of, as I said, the remediation going on. We had -- you're correct, a $250 million hold back from the purchase price from Strides. We did transfer $150 million or settle with Strides for 100 -- them to receive $150 million of that, and $80 million of it was for the lost revenue that we were talking about -- we're talking about here and $20 million relates to another separate issue that had been agreed at the time of the closing of the transaction. So it is not for -- the compensation that we received is not for reimbursement of cost. There is a separate escrow account that is set up and the remediation that's been ongoing has been reimbursed out of that escrow account. This compensation was for lost revenues.

Our next question comes from Ken Cacciatore of Cowen and Company.

My first question is -- just wondering how you think about growth versus accretion when it comes to future M&A. There's clearly a lot of assets that will provide accretion, but wondering how you view growth and maybe even durability. That's the first question. Then the second question is it seems that -- it sounded as if you're frustrated with the FDA. That's my interpretation of your earlier comments. I was just wondering is it because of your own poorly formulated products? Or is it actually issues with the FDA? So just trying to understand seeming placing blame on them and wondering maybe it could be with your own formulations.

Thanks, Ken. So look, I think as far as growth versus accretion, look, I think our track record pretty much speaks for itself. I think that we have added some great complementary strategic assets and accretion. I think we've been very clear about the parameters around M&A that they absolutely would be accretive. And I think that just as I gave the explanation around Abbott, we can bring in an asset that's very complementary and gives great strategic and financial rationale and we'll continue to put that cash to use to ensure that we maintain that strong growth momentum that we've now delivered for 8 years. As far as your FDA question, I am frustrated as I think the industry is. I guess, as far as Mylan is concerned, I'm not aware of any poor formulated products that we have -- have ever had or have in our pipeline. So I'm not sure what your reference there is. I do think that by their own admission, they're having a difficult time efficiently performing while they transform and meeting the metrics that, as you know, we championed GDUFA to level the playing field. And we're working closely with them to enhance and improve the transparency and the timelines and to get us where we need to be -- where they need to be by the end of year 5 in GDUFA. This is the first year -- this is year 3 we're into, and the metrics and so forth, they'll be coming out. So look, I think it is back to a timing perspective, and we look forward to continuing to work with this agency. I think we received -- so with that being said, we've received more product approvals than any other company out there. So while I'm frustrated, I will tell you, Mylan has received more than -- more approvals this year than any of our competitors to date.

Our next question comes from Marc Goodman of UBS.

Heather, maybe you can give us a flavor for what's going on in some of the key European countries. Your press release refers to some pricing pressures. And obviously, France is key and Italy. Talk about, specifically, in those countries, what's happening, the dynamic, how the markets are growing and volume versus price and how you guys are doing.

Sure, Ken (sic) [Marc]. So as I mentioned, we have continued to see pricing pressure there. We have continued to see some volume offsetting that. I would say more so in Italy than France. We continue to see utilization on the rise and the market growing. I would say this about the French market overall. It's been -- from a pharmaceutical perspective, has been fairly flat. So we have obviously maintained our market leadership position there. We've continued, I think, again our durability around our cost of goods, our agility to really be able to key upon key launches there have -- able to let us maintain that. We're excited about launching direct-to-consumer advertising there in France, I think really building upon this leadership. And as far as the other markets outside of just even Italy and France, like I said, we continue to be encouraged by generic utilization increases. And as we've said, nothing happens overnight in Europe throughout the entire region. It is an incremental build, and that's why, again, I go back to being extremely excited around Abbott and our ability to really leverage on both channels, the physician and pharmacy, and really offer something into that market that doesn't exist today, which is a true patient portfolio to the physicians to be able to offer those patients in these therapeutic categories that we're going to have great critical mass around, be vertically integrated in and be able to offer benefit with that pull-through from the pharmacy level.

Our next question comes from Chris Schott of JPMorgan. Christopher T. Schott - JP Morgan Chase & Co, Research Division: Great. I just had 2 here. First, can I just get your view on broader consolidation of the generic industry? I guess, specifically, do you believe consolidation among the larger manufacturers is possible? Or if it makes sense in light of some of the customer consolidation that's occurred? And then second question is coming back to just the next steps post this Abbott transaction. Can I just -- just so I'm clear here, are other established product divisions that may be for sale from some of the large pharma companies of interest to Mylan? Or are you looking at other types of assets given some of those kind of franchise-level kind of comments you made earlier?

Yes, Chris. Thank you. Look, I think -- I used to refer to our industry as hypercompetitive. I'd say now it's hyper-consolidating. And I don't know that I see that stopping. So I think, again, you've got to step back, and look, I won't speak for any of the other large companies. I will speak for Mylan. And I think we've been very vocal that we'll continue to be an acquirer of some great assets that are out there. We believe that we do have the scale and size today with this -- our -- not only the global platform we have, but I'll go back to manufacturing and having the capacity not only to manufacture and put into the market what we do today, but what we're forecasting from our pipeline perspective. And I think that, that really tees us up to serve these global customers. Because I do think that as we continue to see the disruptions in the market, the lack of reliability and some of the positive that a GDUFA has brought, which is I think taking products and some of that capacity out of the market that wasn't where it needed to be from a quality perspective. And I think we certainly are being able to seize on these opportunities. I think, as far as established product businesses, I think what we're in a position to do not only -- as I've said, we're kind of actively looking at everything. We're also, now with this infrastructure in place, able to also cherry-pick products. So I wouldn't think of it that it's an all-or-nothing proposition. I think now building out the infrastructure, not only that we have in the U.S. but throughout Europe, we'll be able to add some great strategic assets whether that's all of an asset or part of it, in addition to standalone companies and obviously, things that would make sense. And certainly, as we continue to think of the emerging markets, especially in Latin America and how we may grow there, there certainly would be opportunity along those lines as well.

Our next question comes from David Risinger of Morgan Stanley.

Yes. So my first question is for John. So going back to your slides from July, you had indicated adjusted EBITDA for the Abbott business of $600 million, and I just wanted to make sure that I understand the math correctly. So starting with the $600 million, investors should be adding $200 million in future synergies. So that would bring the number to $800 million. And then should investors be subtracting some dollar amount that's now lower after your negotiation for the extra cost of goods sold or pricing terms? Is that the way to think about it? And could you also put that in perspective in terms of what those extra pricing terms may amount to? And then second, could you -- could someone on your management team just provide some more detailed comments on the Lidoderm issues and your expectations for approval timing?

Sure, David. Thanks. And what I would say to you, number one, is, is that if you go back to the slides that we provided back at July that you're referencing, you'll see that one of the metrics that we provided was an adjusted EBITDA multiple of 6.6x based upon that transaction. And that what I was trying to provide in my prepared remarks was a comparison today that as a result of the revised transaction, including the issuance of the 5 million shares to Abbott that, that comparative metric is now 6.4x, which reflects the benefit of the improved pricing that came out of the conclusion of the negotiations with Abbott as well as the issuance of the 5 million shares to them. And you'll see further information on that when we file our S-4. And I'll let Rajiv...

On Lidoderm, I think we continue to work very closely with the FDA to close any outstanding issue. And that's why -- while we are prepared to launch as soon as we get the product, we have taken it out of this year's guidance just on financial prudence.

Our next question comes from Greg Gilbert of Deutsche Bank.

One on Abbott, John. Is there an opportunity to improve gross margin on that business once you take control of the manufacturing, whenever that might be? And then for Rajiv. Do you still believe that generic Copaxone could be approved at any time? You've been saying for some time that you've resolved all issues or questions. So I want to make sure that you believe an approval could happen at any time and wondering why you link that to GDUFA slowdowns. I'm not sure if you are linking those 2 things or not.

Absolutely -- yes, on your first part about the gross margins, Greg, I absolutely believe that not only is there the opportunity to increase the gross margins over time, but I think that we have a proven track record of improving gross margins. If you look at the experience over the last 5, 6 years here at Mylan as we have integrated the Merck acquisition, the Bioniche acquisition, our margins have steadily increased. So I definitely see opportunity as well as a proven track record in that area.

And Greg, as far as Copaxone is concerned, as I said in my prepared remarks, that we do not have any scientific issue -- outstanding scientific issue to date. We have responded -- the last set of questions were responded maybe 6, 8 months back. And we have been working and staying very close to the FDA and we have been guiding The Street accordingly what we have been hearing from FDA. Obviously, the transformation at FDA, the rolling out of GDUFA and all, we have seen overall impact, a huge impact, and that is a slowdown. So we don't see any outstanding issue at this time where we stand. That's why we imply that, yes, we can see approval any time. But again, being prudent, we have taken it out of this year's guidance.

Our next question comes from Sumant Kulkarni of Bank of America.

The first one is in a couple of product-specific ones for Rajiv. Are you still on track to launch generic Advair in 2016 because I think you said market formation today? The second one is what is the latest on generic Vivelle-Dot? And then for John, on accretion, could you give us any color on where the source of the additional accretion comes from, from the manufacturing agreement? Is that due to adding sales, better cost positions or due to some other nonoperational source such as tax?

On generic Advair, all I can tell you, that every milestone which we have identified ourselves way back 2 years when we launched this product, we have been hitting on the track, and the Phase III study has been initiated as we have scheduled. Every manufacturing activity, the commissioning of the plant and everything is on track. And I would say that beyond that, you will hear from us on -- in 2015, our Investor Day. As well as Vivelle-Dot, again, no scientific outstanding issue to date. We have responded to everything and we are expecting approval anytime.

And then on your second question regarding the accretion as a result of the amendment and the 8-K filing. I think we indicated in the 8-K filing that the accretion was the result of improved pricing surrounding the transaction. So it's really on the pricing of a product perspective.

And our next question comes from Jason Gerberry of Leerink Partners.

I just wanted to follow up on Ronny's question about the Lantus program. Can you just confirm, is your Phase III -- do you have a vial or a pen delivery there? I'm just sort of curious if you're going after interchangeability to the vial or the pen delivery? I know that your partner had a pen? And then this is my second question. Just as we think about the Abbott transaction, can you just confirm your old pro forma guidance as it related to the, I guess, the pro forma tax rate for the combined entity, which I think was down in the low 20s and then to the high teens over time?

As far as the insulin trial is concerned, yes, we have a pen as a part of this trial.

And Jason, I think actually I had intended, in response to Jami's question, to be indicating that the tax rate was as a result of the inversion that we were still expecting a tax rate in the 20%, 21% range next year and into the high teens thereafter.

And our last question will come from Randall Stanicky of RBC Capital Markets.

Heather, just back on the end of backlog, is there anything that you can point to like a greater volume and complete response letters that could be a leading indicator that things are at least troughing or potentially getting better? And how much of an impact do you think these -- the OGD delays are going to give you for having on broader industry pricing?

So Randall, I hope that, as I stated, October starts the beginning of the third year of GDUFA, which should really be the transformational year as far as metrics and starting to get to the -- and starting to get to where the overall vision of GDUFA was in the first place, which is to accelerate approvals to be able to raise that bar on quality and enhance the transparency. And I, unfortunately and disappointingly, tell you it's gone every -- the wrong direction up until now. I think FDA is aware of this. I hope that going into the very early part of next year, we will be able to see a market -- a markedly different metrics in place for applications that were filed after October 1. I think that where we have been vigilant on with FDA is the backlog issue. So anything before October 1 of 2014, that would have been filed, how they prioritize those. We've been very vocal about, first, generics, how important that is to the market. I think there are certainly broad implications around the lack of approvals that we've had this year. I mean, I think it's been quantified into the billions because of the inability to get products approved at market formation. And I think that as Congress continues to take a hard look at that, I think as a lot of the consumers, that that's really a driving factor and that's what we keep reminding people that we've got to get those approvals in. That's what -- that's the mission statement around OGD. That's what -- that driving force should be there to deliver that to the United States, both as a taxpayer and as to the consumers to get affordable medicine out there. So I can assure you we've not lost sight of the broader mission picture and we'll continue to do our part to make sure everybody else is understanding that, that needs fixed before anything else. Because if we can't get approvals, really fixing anything else isn't going to be very meaningful. And as far as the pricing implications, look, I think -- I continue to say that I think that's a supply-and-demand issue. So yes, do I think there's been opportunities around certain products? But I will say, overall -- I have continued to say generics, overall, per dose or pennies. So it's really, I think, looking -- really looking at the wrong end of the spectrum of where we should be looking at, and it's not the pricing of generic drugs that's driving anything around this health care system, it's really we need to get products approved and get them into the hands of the patient. So with that, thank you.

And operator, you can close out the call.

Thank you, ladies and gentlemen. Thank you for participating in today's conference. This does conclude the program. You may all disconnect. Everyone, have a great day.