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EARNINGS CALL TRANSCRIPT
EARNINGS CALL TRANSCRIPT 2016 - Q2
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Executives

Kevin C. Mannix - Senior Vice President, Head of Investor Relations Erez Vigodman - President, Chief Executive Officer & Director Eyal Desheh - Chief Financial Officer & Group Executive VP Sigurdur Oli Olafsson - CEO & President-Global Generic Medicines Group Michael R. Hayden - President of Global R&D and Chief Scientific Officer Michael M.

Derkacz - Senior Vice President & GM-Global CNS Mike McClellan - SVP & CFO Global Specialty Medicines, Teva Pharmaceutical Industries Ltd. David Stark - SVP, General Counsel for Global Markets, Teva Pharmaceutical Industries Ltd. Sven Dethlefs - Head of Global Respiratory Medicines, GSM, Teva Pharmaceutical Industries Ltd..

Analysts

Liav Abraham - Citigroup Global Markets, Inc. (Broker) Manoj K. Garg - ABR-Healthco Vamil K. Divan - Credit Suisse Securities (USA) LLC (Broker) Elliot Wilbur - Raymond James & Associates, Inc. Gregg Gilbert - Deutsche Bank Securities, Inc. Jason M. Gerberry - Leerink Partners LLC Umer Raffat - Evercore ISI David R. Risinger - Morgan Stanley & Co.

LLC Randall S. Stanicky - RBC Capital Markets LLC Ken Cacciatore - Cowen & Co. LLC David Maris - Wells Fargo Securities LLC Chris Schott - JPMorgan Securities LLC Jami Rubin - Goldman Sachs & Co. Ronny Gal - Sanford C. Bernstein & Co. LLC Irina R. Koffler - Mizuho Securities USA, Inc. Rohit Vanjani - Oppenheimer & Co., Inc. (Broker) Sumant S.

Kulkarni - Bank of America Merrill Lynch.

Operator

Welcome to the Teva Pharmaceutical Industry Second Quarter 2016 Results Call. At this time, all participants are in a listen-only mode. There will be a presentation followed by a question-and-answer session. I must advise you, this conference is being recorded today, Thursday, August 4, 2016.

I would now like hand the conference over to your first speaker today, Kevin Mannix, Senior Vice President and Investor Relations. Thank you and please go ahead, sir..

Kevin C. Mannix - Senior Vice President, Head of Investor Relations

Thank you, Rose. Good morning and good afternoon, everyone. Thank you for joining us today to discuss Teva's second quarter 2016 financial results. On the call with me today are Erez Vigodman, Chief Executive Officer; Eyal Desheh, Chief Financial Officer; Siggi Olafsson, President and CEO Global Generic Medicines; Dr.

Michael Hayden, head of R&D, Chief Scientific Officer; Dr.

Carlo De Notaristefani, President and CEO Global Operations; David Stark, Senior Vice President, General Counsel, Global Markets and GSM, Mike McClellan, Senior Vice President, CFO, Global Specialty Medicines; Mike Derkacz, Senior Vice President and Head of Global CNS; and Sven Dethlefs, Head of Global Respiratory Medicines.

We will start the call with presentations from Erez and Eyal before opening the call up for questions and answers. A copy of today's press release and slides can be found on our website, tevapharm.com, and under the Investor Relations section with the Teva Investor Relation app.

During this call we will be making forward-looking statements, which are predictions, projections, and other statements about future events. These estimates reflect management's current expectations for Teva's performance. Actual results may vary, whether as a result of exchange rate differences, market conditions, or other factors.

In addition, the non-GAAP figures exclude the amortization of purchased intangible assets, costs related to certain regulatory actions, inventory step up, legal settlements, and reserves, impairments, and related tax effects.

The non-GAAP data presented by Teva or the results used by Teva's management and Board of Directors to evaluate the operational performance of the company, to compare against the company's work plans and budgets, and ultimately, to evaluate the performance of management.

Teva provides such non-GAAP data to investors as supplemental data and not in substitution or replacement for GAAP results, because management believes such data provides useful information to investors. And with that I'll now turn the call over to our CEO, Erez Vigodman.

Erez?.

Erez Vigodman - President, Chief Executive Officer & Director

Thank you, Kevin. Good morning, good afternoon and thank you for joining us today. 2016 is a transition year for us. We are focused on fully delivering on our short-term operational and financial goals. And at the same time, moving ahead with our longer planned strategic moves.

During the first half of the year, we drove the Actavis Generics deal, announced the acquisition of Anda, and completed a very successful global equity and debt financing. We closed the JV with Takeda in Japan and the acquisition of Rimsa in Mexico. We are making progress in our specialty franchise.

And we are able to successfully manage the life cycle of Treanda. And lastly, we continued the transformation and optimization of our operational network and the deployment of cost controls and efficiency measures.

In the first 6 months of 2016 we were able to generate very similar results to the strong comparable first 6 months of 2015, without major new generic launches in the U.S., versus the exclusive aripiprazole, esomeprazole, and budesonide were in 2015. Non-GAAP EPS for the first 6 months of 2016 is $2.45, based on share count of 981 million shares.

Adjusted to exclude the impact of the December 2015 equity offering, non-GAAP EPS in 2016 is similar to that in the first 6 months of 2015. Eyal Desheh will cover Q2 in detail. Slide 6 provides you with the revenue bridge and tells the story of the first 6 months of the year.

The loss of exclusivities of generic aripiprazole, esomeprazole, and budesonide were more than offset by the growth of our generic and OTC business in 2016, without adding major new launches in the U.S., and by the growth of our Specialty business versus 2015.

Our Global Generic business generated 26.8% operating margin in the first 6 months of the year. Two days ago, we were very pleased to report the closing of our deal to acquire the Actavis Generics business.

The generics industry is one of the most attractive industries in the world in terms of growth rate, profitability, return to investors, and contribution to healthcare system and societies in the U.S. and across the globe.

The transaction between Teva and Actavis Generics transformed the generics space by combining two of the industry's best generic companies. It cements and broadens our R&D capabilities and highly complements our product pipeline, product portfolio, geographical footprint, and operational network.

It enhances Teva leadership in an evolving customer landscape and massive consolidation across our customer base. Finally, it strongly reinforces our strategy, opening a new set of possibilities for us in Generics and Specialty. Financially, the transaction is very compelling economically.

It is highly synergistic with $1.4 billion in operational and tax synergies achievable by the end of 2019. It is significantly accretive to non-GAAP EPS, with 14% accretion in 2017 and 19% accretion in 2019. And it is expected to generate 9.3% ROIC by the end of 2019.

The combined company will generate more than $25 billion of free cash flow from the beginning of August 2016 until the end of 2019.

On July 21 we completed a very successful global bond offering with total net order book of $100 billion, raising $20.4 billion in three currencies across 12 trenches (sic) [14 trenches], ranging from 2 years to 30 years with average duration of 8.65 years, 1 year longer than our original plan, and blended interest rate of 2.17%.

The total cost of our borrowing for the deal, including the term loan, is 2.12%. And including the cost of the bond offering and cost of hedging 2.32%, versus 2.96% that we assumed in the financial outlook model we shared with the Street before the bond offering, and 3.5% when we announced the Actavis Generics deal.

Anda is one of the leading distributors in the U.S. of generic, brand specialty, and over-the-counter pharmaceutical products and the fourth largest distributor of generic pharmaceuticals in the U.S.

for more than 350 manufacturers to more than 60,000 retail, independent, and chain pharmacies, nursing homes, made order pharmacies, hospitals, clinics, and physicians' offices across the U.S. Anda ships to more than 85% of the pharmacies in the United States. And it is the premier distributor of new-to-market launches to the chains.

Anda is a natural fit into Teva's business model, enhancing the offering that Teva can provide and improving patient access to generic medicine in the United States. Financially, the Anda transaction we announced yesterday is compelling economy.

For the close of the Actavis Generics deal and with everything we have accomplished as a company since the beginning of 2014, we have been creating a new Teva with strong foundation, significantly enhanced financial profile, more diversified revenue sources and profit streams, promising Specialty pipeline backed by strong product development engine in both Generics and Specialty.

This is a platform that will generate multi-year topline and bottom-line growth as well as significant cash flow. There are many moving parts on our patent estate on Copaxone 40mg. And we thought it would be useful to describe to you the major pieces. First, the traditional court process under Paragraph IV of Hatch Waxman that we are all familiar with.

We have five patents that are listed in the Orange Book. Orange Book listing are important, because if we prevail in the court process we are entitled to an automatic injunction. Trial on the first four patents is scheduled to commence next month on September 26 in front of Judge [Gregory] Sleet in the District of Delaware.

During the trial, the judge will assume the patent is valid. And the plaintiffs have the burden of showing otherwise by clear and convincing evidence. We have not yet brought any action under our fifth patent. Judge Sleet has a lot of experience in pharmaceutical patent matters. And we expect a decision sometime in Q1 of next year.

Appeals of lower court decision are held by the Federal Circuit, and generally take about a year. Though en banc review can take longer, and as we all know, it is not unheard of for the Supreme Court to become interested in this matter.

There is a separate but related process where our patents are being challenged in the patent office, which is relatively new under the America Invents Act, so I will get into a little more detail on this. First off, Mylan and Amneal have challenged our first three patents in an inter-part review known as an IPR.

Back in May, we participated in hearing in front of a three judge panel at the Patent Office, i.e., the Patent and Trademark Appeals Board (sic) [Trademark Trial and Appeal Board], where we defended the validity of these patents. And we expect a decision at any time, but no later than August 25.

There is also a request for the Patent Office to commence a post-grant review of PGR on the fourth patent. The Patent Office has until August 24 to decide whether to commence that proceeding. And if it is declined, we expect an IPR will be sought on that one as well.

Generally speaking, the Patent Office has around 6 months from the request to decide whether to commence a proceeding. And then the process to a decision takes another year from there. Each of the IPR and PGR decisions can be appealed by either side to the Federal Circuit.

And although there's less experience here, that process should take about a year. Accordingly, both the Paragraph IV lawsuit and the IPR, PGR proceedings will need to be decided by the Federal Circuit. These Patent Office proceedings are cancellation proceedings, which mean that they seek to have the patent revoked at the Patent Office.

This would only occur, if at all, after the appeals process is exhausted. One more thing to look for. It is common for the Appeals Board to cancel some claims at issue, but not others. In the event that the Patent Office does so in this case, we'd view that very favorably for Teva, because the claims are independent and expire in 2030.

Also in the event that we prevail on certain claims at the IPR, Mylan and Amneal would be prohibited from making this argument in the Paragraph IV proceedings. In the event that we lose all the claims in the IPR in August 2016, as far as the Patent Office is concerned, we still have the fourth and the fifth patents.

And in addition to that, Judge Sleet is not bound by the IPR decision and can reach a different conclusion. So finally to conclude, any generic launch prior to a final not appealable court ruling on all five patents, which is not expected before the second half 2018, would be at risk. Moving on to our Specialty pipeline.

We continue to make progress focusing on our four core therapeutic areas. These are the upcoming key milestones in the second half of 2016.

In movement disorders and neurodegeneration business, SD-809 for Huntington's disease, full response to the CRL we received from the FDA is targeted for the end of September 2016 with up to 6 months for FDA to review and target approval by the end of March 2017. SD-809 for tardive dyskinesia, we expect Phase 3 clinical study results.

Pridopidine for Huntington's disease, we expect Phase 2 clinical study results. In pain, we expect approval in the U.S. for Vantrela extended release, our hydrocodone product, and Phase 3 clinical study results for immediate release hydrocodone. In respiratory, we expect two approvals in Europe for reslizumab and for FS Spiromax.

In migraine and headache, we continue to be very excited about the prospects we see in the clinical development of TEV-84125 (sic) [TEV-48125] in episodic migraine, chronic migraine and cluster headaches. Recruitment for the Phase 3 clinical trials in the episodic and chronic headache program is going very well, exceeding our earlier expectations.

And finally, these are our key priorities for the remainder of 2016. We'll put strong focus on the integration of Actavis Generics and the extraction of synergies, while we continue to deliver on our operational and financial targets. In addition, we'll put strong focus on achieving all 2016 key milestones in our Specialty pipeline.

On the business development front, we are targeting attractive pipeline and Specialty assets in our core TAs, biosimilar assets, and strategic platform in key growth markets. And lastly, we plan to provide you with a few business updates in the coming months. September, we plan to hold combined Global Generics medicine business overview.

Before the end of the year, we plan to hold a Specialty medicine R&D day. And in conjunction with 2016 full year results, we plan to provide in early 2017, detailed 2017 financial outlook. Thank you. And I would like to turn the call over to Eyal..

Eyal Desheh - Chief Financial Officer & Group Executive VP

Thank you, Erez. Good morning and good afternoon, everyone. Following a busy week of closing one major deal and signing on another one, I am pleased to review the financial results of the second quarter of 2016. Revenues and non-GAAP profit came above our updated guidance with over $5 billion in sales and $1.25 in earning per shares.

On an apple-to-apples comparison, adjusting for the number of shares we raised last December, earnings per share was $1.43, same as in the last quarter in – second quarter in 2015. Our GAAP net income and earnings per share this quarter were lower than last year.

This is due to expenses related to the voluntary withdrawal of Zecuity from the market and the termination of our involvement in the development of Revascors (sic) [Revascor]. These two events amounted to $546 million of total adjustments. During the past 4 quarters, we generated over $5 billion in cash flow from operation.

Cash flow this quarter with light, due to large cash tax payment, which were $500 million higher compared to Q1 this year. On our liquidity trends, liquidity ratios continued to be strong this quarter. However, following the Actavis closing early this week, our total debt increased by approximately $25 billion.

On EBITDA, we continued to generate strong EBITDA trends of $1.6 billion to $1.7 billion this quarter and ended at $1.7 billion, which is one of the highest in recent quarter. Now let's take a look at the results of the business this quarter. Exchange rates reduced revenues by $141 million compared to Q2 2015. Revenues of our U.S.

Generic business was impacted by competition to our aripiprazole, esomeprazole, and budesonide, which were the major drivers of our Generic business in the U.S. in the second quarter last year. This was compensated by the performance of our Global Generic and OTC business, strong sales of Copaxone, and our Specialty product portfolio.

When you look at revenue distribution by region, U.S. was down and accounted for 53% of total revenues. Europe and the Rest of the World were up and accounted for 25% and 22% of total sales, respectively. Revenues by business line showed $170 million decline in Global Generic.

And a nice growth coming from Copaxone, Specialty products and our OTC business. Operating profit for the quarter, which were similar to last year, were influenced by the decline of our aripiprazole, esomeprazole, and budesonide due to competition.

While the rest of the Global Generic business improved nicely, but not enough yet to compensate for the entire decline, Copaxone and Specialty business generated $120 million (sic) [$122 million] improvement of operating profit over last year and compensated for that.

So our Global Generic business accounted for 33% of profit contribution this quarter, Copaxone was 49%. And Specialty products, 17%. Despite the year-over-year decline in major generic products, profit margins stayed healthy due to COGS reduction and more profitable product mix.

Copaxone continued its strong performance with exceptional sales of over $1.1 billion this quarter. Script level remains flat over the past 4 quarters. Now let's look at the numbers for the first half of 2016.

First half of 2016 revenues and non-GAAP profits were similar to the first half of 2015, while our GAAP net income was down $100 million due to the Q2 2016 impairment that I reported earlier. For the first 6 months, Generics were down and accounted for 45% of total revenues, while Copaxone and Specialty products were 23% and 22%, respectively.

Looking at profit contribution by lines of business, Generic contributed 32% of our total profit contribution for the first 6 months of this year. Copaxone was 47% and our Specialty product contributed 19% of total contribution. Dividends.

So dividend payments for Q2, as approved and declared by our board, remain unchanged at $0.34 per regular share per quarter. I would like to talk about our financial outlook.

So I would like to reiterate the 2016 financial outlook, which we provided just a few weeks ago, of revenues at $22 billion to $22.5 billion and non-GAAP earning per share at $5.20 to $5.40. The strong non-GAAP EPS, which we generated in Q2, are included in this forecast. So I'd like to thank you all for listening to our remarks about the quarter.

And I would now like to open the call for questions. Thank you very much..

Operator

Thank you. Questions will be taken in the order they are received. In the interest of time please limit yourself to one question and one follow-up question. Your first question comes from the line of Liav Abraham [Citigroup]. Please ask your question..

Liav Abraham - Citigroup Global Markets, Inc. (Broker)

Good morning. First question for Siggi on the Generics business. U.S. Generics revenues were a little lower than expectations.

Can you just talk to us again about your conviction in pricing stability on the dynamics in the industry? And was just this a case of us just not properly modeling the impact of Abilify and Nexium in the quarter? And then secondly, Michael, on SD-809 in Huntington's, perhaps you can give us an update there on where you stand on addressing the FDA's request for additional data.

And your confidence that no additional data in humans will be required by the FDA? Thank you very much..

Sigurdur Oli Olafsson - CEO & President-Global Generic Medicines Group

Yeah. Thanks, Liav. I think first of all, it's the old story in the Generic business and we have talked about it many times. It's the short-term volatility, but the long-term profitability that we are seeing in the Generic business. I think on the U.S.

side, clearly the impact we highlighted, the impact of having our competition on aripiprazole, esomeprazole, on budesonide was very, very significant. I think overall, the underlying business did well. We had that one quality recall in the quarter, which affected our business a little bit.

But overall, the impact was that we didn't have any significant new launches. This always happens quarter to quarter when there's no significant launches. So I think in terms of the revenue of the U.S. business, we were in line with our expectation going into the quarter. In terms of the pricing. The pricing is stable to the same degree as before.

We saw approximately in the U.S. 4% price erosion in the business. In a way, very stable from first quarter. And the global pricing impact we saw in the business, in the Generic business, was approximately 5%. So we are pleased with the environment. I think we are coming now in line with our other competitors that have been reporting.

We are saying – seeing the same price erosion in the market as others. So I think overall, a good quarter. There was a volatility due to the exclusive products we have a year ago. But overall, a very, very good quarter for the Generic business of Teva..

Michael R. Hayden - President of Global R&D and Chief Scientific Officer

Thank you, Liav. Just to come back to the SD-809 issue. So we have completed essentially all of the experimental work. This is also non-human studies. No clinical trials, but measurements of various metabolites. The request for the Type A meeting has gone back to the FDA.

We expect this meeting within the next month, with full response to the CRL by the end of September. So we're totally on track. We've been able to I think completely resolve the issues that the FDA has raised. Of course, it's impossible to totally predict what the FDA will say.

But we're very confident that the integrity of the data and the nature of the response will provide support for approval of this particular product shortly thereafter..

Liav Abraham - Citigroup Global Markets, Inc. (Broker)

Thank you..

Kevin C. Mannix - Senior Vice President, Head of Investor Relations

Next question?.

Operator

Your next question comes from the line of Manoj Garg [ABR-Healthco]. Please ask your question..

Manoj K. Garg - ABR-Healthco

Hi. Thanks for taking the question. I have two. Actually one for Eyal and then one general one. Eyal, in your preliminary guidance issued last month, you included a cost of financing of about 2.8% to 2.9%. But by my math, at least in the initial years, I'm getting a cost of capital substantially lower of about 2.2%.

Can you confirm that?.

Eyal Desheh - Chief Financial Officer & Group Executive VP

Yes. I think Erez just in his comments of 2.32%..

Manoj K. Garg - ABR-Healthco

Okay. Oh great. Sorry. I apologize. I must've missed. And then this morning, Momenta has a press release out saying that they're expecting tentative approval on the 40mg this year.

So just wanted to see if you guys had any commentary on that?.

Sigurdur Oli Olafsson - CEO & President-Global Generic Medicines Group

I think, just to say on that, I think Momenta has said before that they have a targeted action day for the 40mg this year. So I don't think there's any new information..

Manoj K. Garg - ABR-Healthco

Okay. Thank you..

Kevin C. Mannix - Senior Vice President, Head of Investor Relations

Great.

Next question?.

Operator

The next question comes from the line of Vamil Divan [Credit Suisse]. Please ask your question..

Vamil K. Divan - Credit Suisse Securities (USA) LLC (Broker)

Great. Thanks so much for taking my questions. I'll – just one if I could on the Copaxone side, building off that last question. Maybe you can give a little bit more insight into what you're seeing in terms of share? And it seems like you got a little of benefit on price and some of the rebate this quarter.

Maybe you can give us a little more detail there on how that impacted the numbers? And what your expectations are for pricing going forward? Thanks..

Unknown Speaker

Mike..

Michael M. Derkacz - Senior Vice President & GM-Global CNS

Hi. Yeah. Hi, Vamil. Thank you very much. So on the Copaxone share, I think we're very, very pleased with the fact that 40mg is about 83% the U.S. market. Of the number one product in the MS category now, of course, is 40mg at a 24.1% share. And I think of equal importance is the fact that the EU remains on track with the U.S.

We're quickly approaching a 60% conversion in Germany. We lead with new patients for Copaxone. And I think this just speaks to the support by payers, by patients, by physicians around the long-proven track record of safety and efficacy of the product and a tribute to the team's great work here..

Kevin C. Mannix - Senior Vice President, Head of Investor Relations

Any additional questions, Vamil?.

Vamil K. Divan - Credit Suisse Securities (USA) LLC (Broker)

Just maybe a little bit more on just kind of expectations on pricing going forward? And just a little bit more, if you could break out sort of the impact of the Medicaid rebate versus the net pricing you're getting, given your price increase?.

Mike McClellan - SVP & CFO Global Specialty Medicines, Teva Pharmaceutical Industries Ltd.

Yeah. What we've seen in the quarter, if we compare to last year, is that sales are relatively stable. We have pretty stable volumes and a little bit of a favorable price impact. We did have a nice upside this quarter, because of a favorable mix. But overall, sales without that favorability would be relatively stable with last year..

Vamil K. Divan - Credit Suisse Securities (USA) LLC (Broker)

Okay. Thank you..

Kevin C. Mannix - Senior Vice President, Head of Investor Relations

Next question?.

Operator

The next question comes from the line of Elliot Wilbur [Raymond James]. Please ask your question..

Elliot Wilbur - Raymond James & Associates, Inc.

Thanks. Good morning. A question around the recently acquired Anda business, both financial and then strategic.

First, with respect to financial can we just take the run rate that Actavis talked about – or Allergan talked about in their press release, annualize that, and add that on top of the guidance that you have recently provided? In other words, is that business purely additive? And maybe you can talk about sort of what you see kind of in the terms of trends in the – within the framework that – or the guidance timeline that you had previously talked about through 2019? And then just maybe, perhaps, for Siggi, strategically can you talk about – I mean what does that business really do for Teva? I mean I guess the historical knock against it, in terms of being owned by a generic company, was that it somehow worked against you? And you're competing with your customers? Obviously that never hurt Actavis in the amount of time that they owned it.

But just sort of curious and kind of how you view that historical perspective? And what that business really enables you to do? Or sort of what the benefit is of owning it? Thanks..

Sigurdur Oli Olafsson - CEO & President-Global Generic Medicines Group

Yeah. Thanks, Elliot. So if we start on the finances, how you need to think about it is, we reported obviously the third party revenue versus the total revenue that Allergan reported in their PR. I think what you need to keep in mind, that obviously in the third party revenue, as we reported it, includes Teva revenue.

So what we need to do when we close the transaction is to see if there is an overlap of Actavis versus Teva products, because of the combination and things like that. But overall, the third party revenue we gave for estimated for 2016 was in the excess of $1 billion on the revenue.

In terms of contribution, I think it's within the margins that we gave a guidance few days back. The contribution to the overall business will fit nicely within the guidance ranges that we gave few days back. With regards to strategically, I have to say I'm extremely excited about this, obviously from my Actavis days 2 years, 3 years ago.

And I know this business extremely well. It really gives us an opportunity to service our customers better, not only on the Generic side, but also in terms of our Specialty business. It's the access to 60,000 plus pharmacies within 24 hours of service.

It really is not a big threat to the big three customers, because obviously Anda is significantly smaller. But it relies as a service function, to help also the big three customers. And many of them use Anda as a primary/secondary, as we call it, where they rely on Anda to step in if there's shortage in the market.

Also there's biosimilars coming to the market. There's an opportunity of delivering straight to the clinics, to the doctors' offices. They have a cool chamber. They have their warehouses in Mississippi next to the FedEx site.

And really overall, I think it's the next step for Teva in getting closer to the customers and giving back to services in the market. So exciting next step for Teva in the future..

Kevin C. Mannix - Senior Vice President, Head of Investor Relations

Next question?.

Operator

The next question comes from the line of Gregg Gilbert [Deutsche Bank]. Please ask your questions..

Gregg Gilbert - Deutsche Bank Securities, Inc.

Yes. Thanks. Good morning. Good afternoon. First for Erez and Eyal, how much dry powder do you have right now to make acquisitions? And is it fair to say your strategy on acquisitions is much more focused on Specialty brands versus Generics at this point? And then secondly for Siggi, not to steal thunder from your upcoming Analyst Day.

But how can you best support your confidence in that strong mid-single digit growth outlook for Generics over the next several years? In light of just sort of that mid-single digit erosion, can you give us a little bit more color for that? Thanks, guys..

Erez Vigodman - President, Chief Executive Officer & Director

Hi, Gregg. So we expect to generate, and I said it and I'm reiterating it now, more than $25 billion of free cash flow from this close until the end of 2019. $5 billion are – basically are designated for dividend distribution until the end of 2019. And the rest is going to be divided between paying down debt and entertaining attractive Specialty deals.

We might also look at attractive platforms in key growth markets. That's the focus, and that's how we have been shifting the focus from BD [business development] perspective and to basically to – yes. And I'm reiterating it to attractive Specialty assets..

Gregg Gilbert - Deutsche Bank Securities, Inc.

Okay..

Sigurdur Oli Olafsson - CEO & President-Global Generic Medicines Group

Yeah. And, Gregg, on my confidence on the mid-single digit growth. Obviously have – we have only had the keys for about 2 days, so it doesn't give me a lot of time to validate what we have talked to before. But everything we have seen in the last 48 hours has built even more confidence in the data.

So what we are doing now is that we are validating the pipeline. We are validating the IP situation. We are validating the regulatory affairs to understand and build it up per year.

And then in September, hopefully in first half of September, we want to come out with – to investors and show you the pipeline and how the possibility it could align throughout the years. With everything we see after 48 hours, it has only built the confidence. But I think you need to wait up until September, so we can show you the real picture.

And maybe give you some hint of the molecules, when they could come. Obviously there are some dates, certain settlements that we want to highlight to investors. But overall, it's the same formula as we talked about before. Rebuild about 5% erosion from volume and price.

And then a 10% increase from new product launches, which would give us a 5% or mid-single digit overall growth of the business, which I think is reasonable. And we are still sticking by what we talked about before, approximately 1,500 product launches in 2017..

Gregg Gilbert - Deutsche Bank Securities, Inc.

Thank you..

Erez Vigodman - President, Chief Executive Officer & Director

And, Gregg, as far as 2016 is concerned, we have a capacity of $3 billion to $4 billion for potential BD deals until the end of 2016..

Gregg Gilbert - Deutsche Bank Securities, Inc.

Thanks for that color..

Kevin C. Mannix - Senior Vice President, Head of Investor Relations

Next question?.

Operator

Your next question comes from the line of Jason Gerberry [Leerink]. Please ask your questions..

Jason M. Gerberry - Leerink Partners LLC

Hi. Thanks for taking my question. Just to dovetail I guess off Gregg's question. Siggi, you guys – it looks like you guys were able to keep both the Advair programs, yours and Teva's.

So kind of curious where you guys stand in the race for a generic Advair? Just curious if you have an updated view now that you've got both assets?.

Sigurdur Oli Olafsson - CEO & President-Global Generic Medicines Group

Yeah, so, Jason, on the Advair program, obviously again only 48 hours. But both programs we are going to take two shots at goal. I think it highlights that because we keep both – clearly neither program has completed the Phase 3 study. So our goal is still to file this by the end of next year, beginning of 2018. We have to see.

Obviously there's many risks in the way. But I think it gives us an opportunity in taking us, these two shots at goal. Our intention is to continue with both programs, so we have a better chance of introducing a generic interchangeable AB-rated Advair to the market in not-so-distant future.

But we are not at the point in time now where we can give you more exact timelines..

Jason M. Gerberry - Leerink Partners LLC

Okay. And if I could just squeeze a follow-up in, just on – actually on Vamil's question around the Medicaid mix. Is that just a 2Q phenomenon? Or are you kind of transitioning away from the Medicaid business? And should we expect sort of better gross to nets as a byproduct of that on a go-forward basis? Thanks..

Unknown Speaker

Yes, what we've seen in the quarter is that the Medicaid scripts tend to come in on a 9- to 12-month lag. So as we had the launch of Glatopa as a competitor, we've made estimates over the quarter. And what we've seen is a slightly favorable mix come in. Some of that is affecting the go-forward business.

But a chunk of it is a revision of past estimates, which the underlying business, as we said before, is relatively stable. So the upside you see versus last quarter last year is basically the revision of estimates..

Jason M. Gerberry - Leerink Partners LLC

Okay. Thanks..

Operator

Your next question comes from the line of Umer Raffat [Evercore]. Please ask your question..

Umer Raffat - Evercore ISI

Hi. Thanks for taking my questions. Perhaps a few, if I may. Erez, how are you thinking about the timing of capital deployment in Specialty? And I know you mentioned four core therapeutic areas, so I know it's neurology, pain and respiratory.

Is your fourth one oncology? And are you open to BD in oncology? Siggi, so on Generics, it seems like volumes are down 10% sequentially versus the first quarter. And the reported sales are also down a similar number.

So what I'm trying to understand is, are you sticking to like a 4% price erosion? And if there's anything – if there's any part of the portfolio that's eroding price beyond that, were you surrendering volumes? I just wanted to understand what we're seeing in IMS. And then finally, Eyal, I had a question on non-GAAP.

So the 20% royalty on BENDEKA is not reflected in the non-GAAP P&L.

So I just wanted to understand how can investors better understand non-GAAP results, especially if BENDEKA continues to be an important part for many years to come?.

Erez Vigodman - President, Chief Executive Officer & Director

So, Umer, thanks for the questions. Four core therapeutic areas encompasses neurodegenerative diseases and movement disorders, [headache] migraine and [headache] pain and respiratory. We might pursue BD deals already in 2016 and 2017..

Sigurdur Oli Olafsson - CEO & President-Global Generic Medicines Group

On, Umer, quickly on the volume. So first of all, there's probably three or four things to this question. Overall, the IMS volume is not as accurate as we would like it to be. It's still a decline, but it's not nearly at the 9% we are talking about. So there's a few things that play into it.

First of all, the three products that we talk about obviously play into it. The second thing that plays into it is the Gödöllő [plant in Hungary], which we mentioned before, the quality issue we had in our injectable side.

But we also had versus previous years, there's an impact from a third-party manufacturer in India, Emcure, which has a significant volume impact but very little impact on our profitability or the top line. So overall, the business itself is fairly stable. As I mentioned in the beginning, we are seeing exactly the fulcrums in price erosion.

There is not such much movement in the other volumes. If you take away these two exceptions, the rest of the volume seems to be intact. And then some of the product, there has been a small volume increase. So overall, a stable business, 4% price erosion in the U.S.

And I think a great base to build on now when we combine the two businesses for the future..

Eyal Desheh - Chief Financial Officer & Group Executive VP

And over on the BENDEKA royalty, BENDEKA royalties are charged into enter the GAAP and the non-GAAP, what you have seen on a regular basis. What you have seen is as a result of the win that we had, we had to increase the future value of the Eagle transaction.

And that is a little bit over $100 million of entry that we have in the GAAP result that wasn't eliminated through non-GAAP. But on a regular basis, of course the royalties are part of the costs..

Umer Raffat - Evercore ISI

Thank you very much..

Sigurdur Oli Olafsson - CEO & President-Global Generic Medicines Group

Also have a comment. Just to give you a little bit more flavor. In the four therapeutic areas, of course migraine and pain is our leading areas with a total number of programs around 35, 12 in migraine and pain, 10 in movement disorders/neurodegeneration, around nine in respi, and then we have some others.

For example, neuropsychiatry as well and biosimilar development. So it's quite focused and very specifically focused in the areas that we've spoken about in the past..

Umer Raffat - Evercore ISI

Thank you..

Operator

Thank you. Your next question comes from the line of David Risinger [Morgan Stanley], please ask your question..

David R. Risinger - Morgan Stanley & Co. LLC

I have two questions. The first is for Siggi. The second is for Michael. So with respect to the Anda business that you're acquiring, could you just provide a little bit more perspective on whether you expect Anda to lose supplier customers, because suppliers are less inclined to work with Teva as a much bigger leader in the U.S.

Generics market? And then second, with respect to SD-809, Michael, are you planning to launch the drug next spring? Meaning, how high is your conviction that you'll be getting the drug approved next spring? Or is there enough uncertainty that you can't have extremely high confidence at this point? Thank you..

Sigurdur Oli Olafsson - CEO & President-Global Generic Medicines Group

Thanks, David. So on the Anda thing, so first of all, keep in mind that Anda, it will be, when we close the transaction, a standalone function within Teva. There will be Chinese wall. It's not part of the ongoing business. And we will report it separately. Second thing to think about is Anda is a great service functions to the other pharma companies.

So they really want to work with Anda. Anda has a great business, working with the independent pharmacies. And also their role of being, as I mentioned before, the primary/secondary. I think even though we are competitors in the market, I think the company sees us as a great opportunity to be in a position to work with Anda.

And Anda has a reputation in the market to be one of the best supplier, best service, great for incentives. And maybe the third point to mention, yes, there has been a competition between Actavis and Teva. But Teva always has used Anda in the past. Anda has been very professional.

And it's also for that reason why we are so comfortable with Anda, because we knew that the confidentiality of any Teva information never went over to Actavis or the other way around. So I think this is an opportunity for the customers, for our competitors.

In terms of the customers, how they react, I think Anda, as I mentioned before, it's relatively small. It's more of a service. It's a service more to the independent. It can help the big three customers, if anything. So I don't see them as a big threat to the big three customers..

Michael R. Hayden - President of Global R&D and Chief Scientific Officer

And, David, with regard to SD-809, we're confident that we'll be able to launch this by the end of the first quarter in 2017. Important, the issues we believe have been resolved.

Important also to remember that this would be only the second drug ever approved for Huntington (sic) [Huntington's] disease in the United States, the last being tetrabenazine itself in 2008.

This is a fine, proved product with improvement in movement disorder, chorea, improvement in appetite, no swallowing difficulties, walking, and a whole host of others that improve the quality of life of patients without some of the obvious and terrible side effects associated with tetrabenazine, particularly including a tendency to depression and suicide, which is frequent in these patients.

This will represent a major advance for patients. And we do know recent publications that the number of patients with Huntington (sic) [Huntington's] disease has probably been underestimated. It may be a significant increase on what you've seen previously. So we're confident about the response that we have.

And we also recognize importantly the unmet need in terms of patients and the broad spectrum of possibility in terms of improvement in the quality of life of these patients. So we're looking forward to the launch of the second product for Huntington (sic) [Huntington's] disease in the United States early next year..

David R. Risinger - Morgan Stanley & Co. LLC

Thanks very much. And one quick follow-up on that.

Why did the FDA assign a 6-month review clock, rather than a 2-month review clock, given the desperate need of many patients in the United States?.

Michael R. Hayden - President of Global R&D and Chief Scientific Officer

Well, no, that's an excellent question. Now it's technical. So if you look at a Type 1 or Type 2 submission, Type 1 says that it's a review of data and no new data. Type 2 refers to new data. So the FDA has the opportunity, if it's very technical, they could go as much as 6 months. Of course we're hoping for less.

But we don't know how they'll interpret this as totally new data or extrapolation of old data. So – and the FDA has not yet determined this, because we haven't really – they haven't yet seen the data. So we're giving the outside view of this. But of course we would hope this might be earlier in view of the unmet need..

David R. Risinger - Morgan Stanley & Co. LLC

Thank you..

Operator

Thank you..

Kevin C. Mannix - Senior Vice President, Head of Investor Relations

Next question?.

Operator

Thank you. Your next question comes from the line of Randall Stanicky [RBC]. Please ask your question..

Randall S. Stanicky - RBC Capital Markets LLC

Great. Thanks. I just have two. The first is for Siggi and then for David. Siggi, as some of your Indian peers collect approvals that they are not launching, or at least have not yet launched, and as we see some of their domestic competitors here having some pretty significant competitive challenges.

How much risk is that of irrational behavior? Or even opportunity for you is that? How do you view that?.

Sigurdur Oli Olafsson - CEO & President-Global Generic Medicines Group

Yeah. So, Randall, with 208 generic companies in the U.S. market, the competition is fierce. There's no question about it. There has been more approvals you have seen. There is a pickup of approval. But overall, there hasn't been so many launches.

Because also I think company know and we know it ourselves, if you are the eighth or the ninth approval, it is a very difficult market to add value to the customers to bring a product to the market. So many of the approvals, because you see a lot, many, many product approvals, but they are not the exclusive approval so much.

So I think the companies are different. I think most companies have started to understand how the market functions. But it is a fierce competition in the market. There's no question in my mind that, with 208 companies, there's on average now from the FDA approximately 55 to 60 approvals every month. We need to be on top of our game.

The other side of the coin is of course that we have 336 ANDAs pending at the FDA in the new combined Teva. So when the FDA picks up the pace in approving our competitors' products, we have approximately 10% of all ANDAs is in the name of Teva now at the FDA. So I think we will also see the benefit from the FDA picking up the pace.

And that will give me – that gives me the comfort of the mid-single-digit growth. But you're absolutely right. This is a crowded market. There's a lot of competition. And there's new approvals coming..

Randall S. Stanicky - RBC Capital Markets LLC

Okay. Great. And just if I can switch, just, David, for a second on Copaxone. The next major data point we're going to have here are going to be the three IPR decisions later this month. And if they go against Teva, I guess a couple questions.

Do we know how Judge Sleet is going to treat those? If he'll include those in the litigation or not? Obviously the fourth patent would be included.

And then does that have any impact relative to the PTAB finding if – relative to what Judge Sleet views on those patents? Can you get an injunction off of anything that he may find?.

David Stark - SVP, General Counsel for Global Markets, Teva Pharmaceutical Industries Ltd.

Yeah. Hi, Randall. This is David. Thanks for the question. So the judges have discretion in terms of how they manage their docket. But that said, we have a pretty high degree of confidence that in that fact pattern that you described that Judge Sleet would go ahead, just as you mentioned.

And particularly on the fourth patent, which is not going to be part of the IPR decisions. So our view is, is that there's a very high degree of likelihood that the trial will go ahead.

And thanks for the question around the injunction, because those patents are in the Orange Book unless and until those patents would be canceled, there would be an automatic injunction if we were to prevail in front of Judge Sleet..

Randall S. Stanicky - RBC Capital Markets LLC

And can he relitigate the patents, even if the PTAB invalidates them?.

David Stark - SVP, General Counsel for Global Markets, Teva Pharmaceutical Industries Ltd.

So again, if the PTAB rules against us in the IPR, that would be appealed to the Federal Circuit..

Randall S. Stanicky - RBC Capital Markets LLC

Okay..

David Stark - SVP, General Counsel for Global Markets, Teva Pharmaceutical Industries Ltd.

Just as Judge Sleet's decision would be appealed to the Federal Circuit. And until the PTAB procedure completely runs its course, we would still have an injunction, an automatic one, in front of Judge Sleet if we were to prevail. I hope that gets at your questions..

Randall S. Stanicky - RBC Capital Markets LLC

Yeah. Yeah. No, it's helpful. Thank you..

Operator

Thank you. Your next question comes from the line of Ken Cacciatore [Cowen]. Please ask your question..

Ken Cacciatore - Cowen & Co. LLC

Hi. Thanks. Just a couple. First, Siggi, I know it's been brief. But you should have some insights at least into the Allergan's generic business operating margins maybe. And just general health, even though it's been a short window of time.

If you could just maybe compare and contrast to your current operations standalone? And also just a general question, whoever wants to field it. On Mylan's Advair, you all are clearly an interested party here. You're a major shareholder.

So can you give us any insights into your belief around that as a shareholder? Clearly you own a lot, and it would be a good liquidity event.

So wanted to get your perspective, if you thought it could be AB-rated and approved?.

Sigurdur Oli Olafsson - CEO & President-Global Generic Medicines Group

Good question, Ken. So first of all, on the operating margin, we obviously – we cannot comment on their quarter 2 business. I think Allergan has their results next week. But overall, we are very pleased with what we see. We have a stable business, it's growing. I think a very interesting pipeline.

And we also highlighted that when we give a guidance to the Street that really on both sides, in Teva and in Actavis, both R&D groups did amazing jobs over the last 12 months to continue to build the pipeline. In terms of the operating margin, we have to see. We have to do the calculation.

As I mentioned before, we are at close to 27% in the Generic business in Teva for this quarter. My guess would be they are at about just over 30% in the operating profit. You have then to keep in mind that we are swallowing all the negative synergies now, because all the divestitures will come in now. And all the cost will still be on the books.

So there will be a small hit on the operating profit for the first few quarters, until we start to realize the synergies. So there will be a negative bump in the beginning, which will then over the 3 years, until the end of 2019, I would foresee the Generic business to be in the mid-30s% in terms of operating profit.

But you need to I think model it pretty accurately, because of the negative bump you will see in the beginning, due to the divestitures are hitting us on day one. In terms of Mylan Advair, I think it's not for us to comment. I have to say I think it's a great achievement that they submitted an ANDA that is under review. We can't comment.

We haven't seen the dossiers. But they have a targeted action. They not so – quite close in time. But we can't comment on their approvability. But clearly achievement to finish and submit the dossier in this timeframe they talked about..

Ken Cacciatore - Cowen & Co. LLC

Thank you..

Erez Vigodman - President, Chief Executive Officer & Director

Maybe just to clarify on what Siggi had just said, 2017 already net synergies, after the negative synergies, is positive, $0.4 billion of positive net synergies. That's something that we shared with the Street 2 weeks ago.

So just to give meaning to message – statement that was made there by Siggi, we are positive already, $400 million positive, after negative synergy, in 2017..

Kevin C. Mannix - Senior Vice President, Head of Investor Relations

Rose, next question..

Operator

Thank you. Your next question comes from the line of David Maris [Wells Fargo]. Please ask your question..

David Maris - Wells Fargo Securities LLC

Good morning. Just first on clarification, what were the Takeda revenues in the quarter? And is that fair run rate? And is it growing? And then, Erez, in a recent interview and previously you've spoken about the merging of information technology and therapeutics as an important part of healthcare. And that Teva is going to participate in that.

Can you maybe describe what your efforts are there right now?.

Erez Vigodman - President, Chief Executive Officer & Director

Sure. I think the best way to describe things at this stage is as follows. First, we focus on unlocking value from Generics, unlocking value from Specialty. There is a huge opportunity for us to generate value to our shareholders from Generics and from Specialty on a standalone basis.

Other time we saw maybe a little bit of focus in the industry would shift from product only to broader unmet needs of patients, increasing adherence compliance and by pressing prevention, prediction. And basically that's an opportunity for us.

We believe that we are positioned as a company to address the broader unmet needs of patients, in a way which is not confined to medicines only. On a step-by-step basis continue to unlock value from Generics and from Specialty. We'll catch up synergies and we create more opportunity with patient.

And there are moves that we are – have been already carrying out. We'll be in a position to share that with the Street I believe early next year or in the course of 2017 with more details..

Michael R. Hayden - President of Global R&D and Chief Scientific Officer

And, David, on the – your question on the Takeda revenue contribution, we're not providing country by country. And also confidentiality agreement with Takeda prevent us from being specific.

But there is a view if you go into the details in our P&L, you can see some estimate of profit contribution with the minority interest line, because we get 51% of the profit..

David Maris - Wells Fargo Securities LLC

Great. Thank you very much..

Kevin C. Mannix - Senior Vice President, Head of Investor Relations

Next question..

Operator

Thank you. Your next question comes from the line of Chris Schott [JPMorgan]. Please ask your question..

Chris Schott - JPMorgan Securities LLC

Great. Thanks very much. Just two here. Maybe first, can you talk about price opportunities on the combined Generic portfolio, now that the deal is closed? As you kind of review the pro forma business, do you see the opportunity to raise price on select products here? Second question was on the environment for business development right now.

I think you talked earlier about maybe $3 billion to $4 billion of capacity in the near term and a lot more over time.

But how attractive of a market are you seeing out there? Have you seen any change in expectations, either from sellers or in the competitive environment for assets that make this either a more or less attractive time to be pursuing some of these Specialty products? Thanks very much..

Sigurdur Oli Olafsson - CEO & President-Global Generic Medicines Group

Yeah. Thanks, Chris. On the pricing as you know and as we know that the size really doesn't affect the pricing. And I have a strong feeling, when you have over 200 competitors, size has nothing to do about pricing. I think the pricing comes with shortages in the market, if you have an exclusive product.

If there's some kind of dysfunction in the market, there might be a small pricing opportunity that usually comes in and comes out. But overall, the size and being a combined company doesn't play into that. I feel quite strongly about that. The environment has to do with shortages, new product.

And of course we have a lot of exclusive products, as we mentioned about 115 first-to-file, further pending. And I think those are the biggest pricing opportunities we have in the future.

I think also what we are going to do, Chris, and this part of it, is we are working hand-in-hand with our TGO, our operation colleagues, to have our products available. Because when there's a shortage in the market the opportunity is to service our customers even better than we do today.

And this is now initiative, so that we are working on very hard in the new Teva, in the new combined Teva, is how can we have more products available. Because when there are shortages in the market, the opportunity comes that we have the products available on a short notice to service our customers.

So I think that will be the focus much more than day one, we can increase the prices. I don't see that in the cards..

Erez Vigodman - President, Chief Executive Officer & Director

And on the second one, just we see attractive opportunities to grow our business to be the complementing core TAs. We don't see basically shifting expectations of potential failure. What plays in our favor is the – basically I would say the perception and the way we have been going and developing our Specialty franchise.

And there is more willingness for potential sellers or potential partners to collaborate with us or to discuss with us a potential deal. And the more we are able to increase the critical mass and to cement the competitiveness, executing on our strategies, or craft that was crafted for each one of the TAs.

There are more attractive opportunities for us with more willingness to entertain deals with us. And that may be the most important factor that influences the likelihood of potential successful deals that we might entertain..

Michael R. Hayden - President of Global R&D and Chief Scientific Officer

And if I could just add to that. As we look at more focus in some of our colleagues and other pharma companies with AZ and Takeda and others refocusing their pipelines. And the recognition of Teva becoming a significant player in migraine pain, movement disorders, neurodegeneration, and respi.

We're seeing a significant number of opportunities, very exciting, come our way. Also looking at innovative types of partnerships, sharing the risk, sharing the benefits, novel complementarities.

And also the partners that we're looking at are not just around products but also around technologies that can enhance and compliance and adherence and add to the quality of life of the patients we serve. So we are extremely busy looking at numerous product.

And I think Teva is becoming recognized as a place to think about for the appropriate development, because of the capabilities in the TAs that we focus in..

Chris Schott - JPMorgan Securities LLC

Thank you..

Kevin C. Mannix - Senior Vice President, Head of Investor Relations

Rose?.

Operator

Thank you. Your next question comes from the line of Jami Rubin. Please ask your question..

Kevin C. Mannix - Senior Vice President, Head of Investor Relations

Jami?.

Operator

Jami, please ask your question. Hello, Jami. Please ask your question.

Jami Rubin - Goldman Sachs & Co.

Hello?.

Operator

Yes?.

Kevin C. Mannix - Senior Vice President, Head of Investor Relations

Jami, you're on. All right. Rose, we'll come back. Next question..

Operator

Thank you. Your next question comes from the line of Ronny Gal [Bernstein]. Please ask your question..

Ronny Gal - Sanford C. Bernstein & Co. LLC

Good morning and thank you for taking my questions. I have three. First, you guys, as I think Umer mentioned, you've got a bit of a lower run rate on some commodity products. And you now have Anda as a differentiator for the distribution business.

If we think about Teva's mix going forward, should we think about you kind of following the good old path, a Watson track, and having a lot more differentiated product and commodity product? Or are you kind of plotting a comeback on commodity product, as you bring more interesting products as well? Second question.

Looking at OUS Generic, this feels like a good quarter to ask about the mix of gross profit between the U.S. and OUS. You seem to have similar revenue numbers between the two. Can you just comment on the profitability kind of like in rough sense between the U.S.

and OUS when it comes to Generic profits? Obviously it will change a lot with Actavis, but it will be good to see. And third, for – I guess a bit on the IP. I noticed the last patent you listed, the '874 patent, which is I guess the last one to be resolved in terms of IP.

That one looks very similar to the three patents which are under APR in terms of being dependent on the three times per week limitation.

Is this fair? That is, is this patent completely separate in terms of decision than the first three? Or frankly, should we think about if the argument around three times per week gets overturned by the court or the IPR, we should think about '874 flowing track?.

Sigurdur Oli Olafsson - CEO & President-Global Generic Medicines Group

So, Ronny, maybe I'll start around the portfolio for Generics. I think clearly with the combination of Actavis Generics and Teva, we will have more differentiated portfolio. With all the exclusive first-to-files that we are introducing over next few years, there will be a movement there.

But we will never be solely on that, because commodity generics will still play a big part. Remember that because of TAPI, our own API, we can compete in the commodity much longer. Over 40% of our products have our own API in it, which is such a benefit to the long live-ity of our portfolio/ And we can still compete.

But we also know that when there's many competitors in the market. And if we can't make a profitable business, we have no hesitation and focus on different. But we really think that we can offer the whole range. As we have mentioned before, we are all the way from a very complex biologics specialty products to a commodity and everything between.

But we really want to drive the overall portfolio with a special emphasis on the more complex generics, which we are extremely good at..

Eyal Desheh - Chief Financial Officer & Group Executive VP

Ronny, on the....

Ronny Gal - Sanford C. Bernstein & Co. LLC

Yes, Eyal?.

Eyal Desheh - Chief Financial Officer & Group Executive VP

Yeah. On the profitability of our Generic pieces, obviously we're not breaking this down. But what you've seen is that the level of profitability was similar to Q1, 26.8%. The difference from last year, mostly due to the three major products that saw much more intensive competition in the U.S. market. We're happy with improvement in Europe.

Our European business, shown very nice improvement in profitability. Some uptick in the Rest of the World. Other than that, the mix has not substantially changed..

Ronny Gal - Sanford C. Bernstein & Co. LLC

But I guess the question there is, if I have to think about a revenue split between the three geographies, is it fair to say that the operating profit split is roughly the same? Is the U.S.

more profitable, less profitable? Just a ballpark of how the profit is divided?.

Erez Vigodman - President, Chief Executive Officer & Director

So, Rest of the World catching up, Ronny, there is one. Second, we see – look for huge opportunities. At the end of the day, most of the time we focus on the U.S. But the Global Generic business we see huge opportunities ex-U.S. We have been expanding our footprint in key global markets. We'll continue to do that.

We'll continue to go to the market – the business also outside of the U.S. And with the increasing profitability out of the U.S., we'll unlock more and more value..

David Stark - SVP, General Counsel for Global Markets, Teva Pharmaceutical Industries Ltd.

Hey, Ronny. This is David. Thanks for the question. You're right that that fifth patent is similar to some of the other patents that we have. But there are differences. This isn't the right forum to get into the details of what those differences are, which would touch on our litigation strategy.

But I would also keep in mind that what we might do going forward with the fifth patent in particular, it's possible that that could end up in front of a different panel at the PTAB or even a different judge. And that could also lead to a different decision. So there are many variables in the mix..

Ronny Gal - Sanford C. Bernstein & Co. LLC

Got it. Thank you, guys..

Kevin C. Mannix - Senior Vice President, Head of Investor Relations

Rose?.

Operator

Thank you. Your next question comes from the line of Jami Rubin [Goldman Sachs]. Please ask your question..

Jami Rubin - Goldman Sachs & Co.

Thank you.

Can you guys hear me now?.

Kevin C. Mannix - Senior Vice President, Head of Investor Relations

Yeah..

Jami Rubin - Goldman Sachs & Co.

Can you hear me? Okay. Great. Thank you. Apologies for that. Eyal, maybe can you explain what is going on in Venezuela? I saw that Rest of World sales were up quite a bit, ahead of our expectations. And some of that was driven by sales in Venezuela. And in addition, other sales or OTC sales have benefited from the inflationary environment in Venezuela.

I'm just wondering if you can, A, quantify what your revenues are? And just explain what's going on? Because it seems that every other company that we cover, certainly large-cap pharma, other generics, have been writing down that business or getting out of it all together. And – while you're going in the other direction.

So if you can talk about that? And secondly, can you, Eyal, tell us what you're assuming for the ProAir franchise going forward? I believe Perrigo will be launching a generic end of the year, early next. And how we should think about revenues? Thanks..

Eyal Desheh - Chief Financial Officer & Group Executive VP

All right. On Venezuela. So Venezuela is not taking a big piece of our business. Actually quarter after quarter, it's a bit down on sales and profit. Total sales, see – we'll publish our full 6-K public report later on today. Total sales were just above $200 million, split about 50-50 between the Generic sales and the OTC sales.

Our profit contribution is not very high, again a bit down compared to Q1 this year, a bit up compared to last year. So it doesn't really move the needle substantially right now..

Jami Rubin - Goldman Sachs & Co.

What's the outlook for that business? Eyal, what's the outlook for that business.

And how should we think about your treatment versus other companies?.

Eyal Desheh - Chief Financial Officer & Group Executive VP

Well, one thing that differentiates us from most foreign companies that – these pharma companies operating in Venezuela is that all our sales are produced locally. We don't import finished products. We have a plant that produces. This is a necessity in the country right now. And we are producing really essential drugs.

Economy of Venezuela, this is not the time and place to analyze, but we know that the economy there is not in good shape to say the least. And we see what the future will bring. Lots of uncertainties. I wouldn't speculate on this either way..

Sven Dethlefs - Head of Global Respiratory Medicines, GSM, Teva Pharmaceutical Industries Ltd.

This is Sven for the ProAir question. So ProAir has seen a slight growth in this quarter over year, last year, primarily driven by gross to net conversion. We have introduced the RespiClick, the new breath actuated device into the ProAir franchise. We see a steady but slow uptake.

We are around about a 3% market share in total prescription volume in the U.S. so far with ProAir RespiClick. And we continue this trend to continue over the next month.

Concerning the overall development of the franchise, I think we have to look at whether Perrigo gets, and when it gets, the approval for the generic competitor through the ProAir HFA device that we have. Internally we plan that we have a full generic entry or, let's say, a generic competition more towards the mid-2018 than in the near future..

Kevin C. Mannix - Senior Vice President, Head of Investor Relations

Thank you. Next question..

Operator

Thank you. Your next question comes from the line of Irina Koffler [Mizuho]. Please ask your question..

Irina R. Koffler - Mizuho Securities USA, Inc.

Hi, thank you for taking the question. There was nice growth on Treanda and BENDEKA that – and I was just wondering if there was any stocking this quarter? And also is Teva undertaking any additional activities to try to preserve BENDEKA beyond 2019? Thank you.

Eyal Desheh - Chief Financial Officer & Group Executive VP

Yeah. So on the business itself, yes, there was some stocking this quarter, once our customer realized that we won on the trial and remain exclusive. So the regular run rate is a bit lower than what you see from Treanda. And BENDEKA we're happy to see very nice conversion to BENDEKA, over 80% right now. Beyond 2019, our settlement are September 2019..

Erez Vigodman - President, Chief Executive Officer & Director

So it is not realistic to expect that we maintain the business beyond the end of 2019..

Eyal Desheh - Chief Financial Officer & Group Executive VP

Yes..

Irina R. Koffler - Mizuho Securities USA, Inc.

Thank you.

Operator

Thank you. Your next question comes from the line of Rohit Vanjani [Oppenheimer]. Please ask your question.

Rohit Vanjani - Oppenheimer & Co., Inc. (Broker)

Thanks for taking the question. I had a couple of questions on the Copaxone litigation and then one follow-up on the Anda acquisition.

So when Mylan and Anda initiated the IPR and PGR processes, was the fifth patent issued, the '874? And if not, would they still have to definitely invalidate that patent?.

David Stark - SVP, General Counsel for Global Markets, Teva Pharmaceutical Industries Ltd.

So this is David speaking. The answer to the question is no. When they initiated the proceedings on those four patents, we had not yet obtained the fifth patent. So the fifth patent, recently listed in the Orange Book, and we haven't taken any action yet with respect to that..

Rohit Vanjani - Oppenheimer & Co., Inc. (Broker)

And then I know you said that if PTAB invalidates on the three patents, it would be appealed to the Federal Circuit.

But if Judge Sleet goes through the case, he can come to a different conclusion on those three patents, correct? Because he has a higher bar to clear? And he's the only one that can lift a 30-month stay? So in a sense he can – sorry, go ahead..

David Stark - SVP, General Counsel for Global Markets, Teva Pharmaceutical Industries Ltd.

No, sorry, I didn't mean to cut you off there. Absolutely correct..

Rohit Vanjani - Oppenheimer & Co., Inc. (Broker)

Okay.

So in a sense he can relitigate those three patents?.

David Stark - SVP, General Counsel for Global Markets, Teva Pharmaceutical Industries Ltd.

Yes.

Rohit Vanjani - Oppenheimer & Co., Inc. (Broker)

Okay.

And then on the Anda acquisition, do you know, Siggi, if they had a retailer alliance? And then I know you said it's nowhere near the big three, but can you grow it and can you use it to offset some of the generic deflation?.

Sigurdur Oli Olafsson - CEO & President-Global Generic Medicines Group

Yeah. So I think how they do is they work with the independents more than anything else. And then they are basically a support of the secondary to the primary accounts with the bigger. I don't know. Obviously we haven't closed the transaction, so we don't know the details around their contracts and things like that.

But, overall, obviously throughout the year, knowing the business for the last 6 years, 7 years, it's a very steady business. It will not be a threat. You think about it. The third-party revenue is just in excess of $1 billion. So it's not a real threat to the big three.

I think what this gives us is the flexibility, better service to all our customers, the big three but also the independent. And a new way to get into the market. It's an opportunity when we have an exclusive launch to get into all the pharmacies within 24 hours of launch. And all these added benefits, I think it's incrementally better for the business.

But it's also the next step in serving our customers better. But will it be a real threat to the big three? Or can we grow it to tens of billions? That's not in the card. It's really the step of maintaining and serving our customers better than we do today..

Rohit Vanjani - Oppenheimer & Co., Inc. (Broker)

But as far as you know, they don't have a formalized alliance, as AmerisourceBergen and Walgreens? Or McKesson and Rite Aid? Or something like that?.

Sigurdur Oli Olafsson - CEO & President-Global Generic Medicines Group

I don't know the answer to that question yet..

Rohit Vanjani - Oppenheimer & Co., Inc. (Broker)

Okay. Thanks..

Operator

Thank you. Your next question comes from the line of Sumant Kulkarni [Bank of America Merrill Lynch]. Please ask your question.

Sumant S. Kulkarni - Bank of America Merrill Lynch

Thanks for taking my questions. I have three quick ones. First, Teva by itself was quite large in terms of facilities.

Now that you've had the keys for a couple of days, could you give an update on the rationalization of facilities? And is it fair to assume that the $1.4 billion in synergies does not assume anything major there? Second, in the new Teva Generics side, is there still anything that you're relatively less strong on in terms of capabilities, that buying might be more efficient than building? And third, can you rank order your prioritization of biosimilars within the $3 billion to $4 billion of business development dollars that you've set aside?.

Sigurdur Oli Olafsson - CEO & President-Global Generic Medicines Group

Yeah. So let me start. So overall, as we mentioned, the $1.4 billion of cost and tax synergies, we didn't identify any new facility. What we mentioned was a decision that had been taken in Teva independently of the transaction and had been taken in Actavis independently of the transaction. We are going ahead with those movement.

But overall, any synergy movement, closing of facility, no decisions have been made. They are not included in the $1.4 billion, because also you need to keep in mind from the time we announce a closure or decide to close a facility until we see a benefit is more than 3 years. So overall, it's not built into that plan. Obviously we will look at it.

We have a lot of facilities, over 18 manufacturing plants around the world. So there might be something we look at. But there's no decisions being made since we signed on any future further facility closure. With regards to the new Generic business, where it might make sense to buy instead of build, you in a way answered that in your third question.

I think biosimilars is probably the point where it might make sense to buy something instead of building it from ground up. We are obviously looking into that.

In terms of other dosage forms, I think we really are covering the whole range from anything from very complex injectables, where Teva has been the leader in terms of slow release injectables, in terms of proteins, in terms of a delivery system, all the way to patches, semi-solids, liquids, that Actavis has been the leader in.

And really everything in between there. But clearly where we are lagging behind is on the biosimilars, where our pipeline is quite thin for the short term. But clearly for the long term, when we talk about Wave 3 after 2021, we have a very exciting pipeline that we are working on.

And the BD front for biosimilars?.

Erez Vigodman - President, Chief Executive Officer & Director

So we don't rule out the possibility of underpinning a potential acquisition of a biosimilar asset or activity. We are assessing the landscape. And with the right one we might entertain a deal..

Sumant S. Kulkarni - Bank of America Merrill Lynch

Thank you..

Operator

Thank you. I would now like to hand the conference back over to Erez Vigodman, President and CEO, for final remarks..

Erez Vigodman - President, Chief Executive Officer & Director

So thank you for joining us today, and have a great day.

Operator

Thank you, ladies and gentlemen, for participating today. For those of you wishing to review this conference, the replay facility can be accessed by dialing within the U.K. on 0845 245 5205 or alternatively on the country code of +44 1452 5500 00, and the reservation number is 521 22137..

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