Earnings Labs

Teva Pharmaceutical Industries Limited (TEVA)

Q1 2017 Earnings Call· Fri, May 12, 2017

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Transcript

Operator

Operator

Good afternoon. Thank you for standing by and welcome to the first quarter 2017 results call. At this time, all participants are in a listen-only mode. [Operator Instructions] I must advise you this conference is being recorded today on Thursday, the 11th of May, 2017. I would now like to hand the conference over to your speaker today, Kevin Mannix, Senior Vice President and Head of Investor Relations. Please go ahead, sir.

Kevin Mannix

Analyst

Thank you, Vivian, and thank you, everyone, for joining us today to discuss Teva’s first quarter 2017 financial results. On the call with us today are Dr. Sol Barer, Chairman of the Board, Dr. Yitzhak Peterburg, Interim President and CEO; Eyal Desheh, Chief Financial Officer; Dipankar Bhattacharjee, Global Generic Medicines; Dr. Rob Koremans, Global Specialty Medicines; Dr. Michael Hayden, Global R&D, Chief Scientific Officer; Hafrun Fridriksdottir, Global Generics R&D; Dr. Carlo de Notaristefani, Global Operations; and David Stark, Chief Legal Officer. We’ll start the call with opening remarks from Sol and Dr. Peterburg, followed by a presentation from Eyal. We’ll then open the call up for questions-and-answers. A copy of the slides can be found on our website at www.tevapharm.com, as well as on our Teva Investor Relations app. During this call, we will be making forward-looking statements, which are predictions, projections or 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 are 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 a supplement of data and not in substitution or replacement for GAAP results, because management believes such data provides useful information to investors. And with that, I will now turn the call over to our Chairman. Sol, if you would please?

Sol Barer

Analyst

Thank you, Kevin, and thank you all for joining us today. Before we get into the details of our first quarter 2017 results, I want to take a few minutes to discuss the board's ongoing search to identify a permanent CEO. As I've indicated previously, this is my highest priority. We are looking for a world-class individual with deep and broad pharmaceutical experience, an individual with experience dealing with global and complex companies with a strong sense of corporate responsibility and proven strategic and operational capabilities. The process is moving along very well. We have interviewed a number of excellent candidates from all over the world. We are extremely encouraged by the talent and the overall quality of the pharmaceutical executives we are meeting with. The board will continue to take the time it needs to find the best candidate, but I am pleased with the progress we have made and the speed at which we are moving. While the CEO search process continues, the work of Teva to stabilize the business and deliver for shareholders has been significant. I said it last quarter and I will say it again, as Interim CEO, Yitzhak has the full support of the board to drive forward on Teva's strategies and key priorities. Execution remains the focus. The industry is facing turbulent times, and there remain challenges in the business. But I am confident that while the board and I focus on finding the right individual to lead Teva forward, we are taking the actions we need to take today to put the company on the right footing to continue to succeed in the future. Teva is doing everything in its power to deliver on its promise to shareholders. With that, let me turn the call over to Yitzhak.

Yitzhak Peterburg

Analyst

Thank you, Sol. Hello, everyone. Thank you for joining us today. Since I took over three months ago, my focus together with the management team and with the support of the board has been to execute on our previously discussed priorities for the year, which are: extracting synergies related to the Actavis Generics transaction; driving additional efficiencies throughout the organization; supporting cash generation and paying down our debt; and delivering on our promises of the specialty pipeline and key generic launches. First let me take you through a quick review of our quarterly results. Q1 started off 2017 generally as expected and as we guided, with it being the lowest quarter of a back-end loaded year. Revenues this quarter amounted to $5.6 billion, resulting in a non-GAAP net income of $1.1 billion and a non-GAAP EPS of $1.06. However, cash flow from operations was relatively soft, amounting to $500 million, negatively impacted by multiple one-time payments that were previously disclosed, including a settlement with the U.S. Department of Justice. Compared to Q4 2016, which marked the first full quarter consolidation of Actavis into our overall group results, revenues declined 30%, primarily due to: impacts resulting from a devaluation of the Venezuelan currency, which totaled $400 million; losses of exclusivity in the specialty segment during Q1; and divestment in the UK related to the Actavis Generics acquisition. We were able to mitigate approximately half of the decrease in the operating profit through a reduction in operating expenses. Now let me elaborate on some of the progress and challenges we experienced with our key priorities. As it relates to our first priority, I'm pleased to report the synergies related to the Actavis Generics acquisition and additional cost reduction which the company has identified is now on track to realize cumulative net synergies…

Eyal Desheh

Analyst

Thank you very much, Yitzhak. Good morning and good afternoon, everyone. Before I dive into the Q1 numbers, let me say a few personal words. As you read in our press release this morning and heard from Yitzhak just now, I will retire from my CFO role in Teva on June 30 this year. So, this is the last quarter I report as the CFO of this amazing company. I shared my views with all of you for 37 quarters in a row, and I hope that I’ve served you well, enabling all of you to better understand Teva and its developing business model. I worked with Teva for over 16 years in two periods, I worked with outstanding people and together we faced challenges and successes. I’m ready and looking forward to the next chapter in my professional career, which will commence soon, and there is no question that I will miss Teva, the excitement, and I will miss the interaction with all of you. I’m sure that I will cross path with many of you going forward. With Mike taking over as Interim CFO, I’m convinced that Teva finance is in very good hands. Mike is an experienced finance executive and will be a great leader to the excellent finance team we have in Teva and we’ll do that during this transition period. So, good luck to you, Mike. Now let’s take a few minutes to review the results of the first quarter of 2017. As always, I will take you through both GAAP and non-GAAP results. Our highlights for the quarter include revenues of $5.6 billion and earnings per share of $1.06 on a non-GAAP basis, and $0.57 on a full GAAP basis. Our GAAP results were impacted by several items in the quarter and I’ll take…

Operator

Operator

Thank you. [Operator Instructions] We have a question from the line of Gregg Gilbert. Please ask your question.

Gregg Gilbert

Analyst

Hi. I’ll ask one multipart question up front. First for Sol, what have you learned so far from the CEO search and what candidates see as pros and cons? Second, are the Women’s Health and European Oncology/Pain businesses the only businesses for which you’re exploring options? And last, generics in the U.S., are you still as confident as you were before in the flow and size of new product sales from launches in 2017? And can you provide any specific color on some of those key launches? Thanks.

Sol Barer

Analyst

So this is Sol Barer, I’ll take the first question in terms of the CEO search. I have to say that we are looking, as everyone knows, for the best person to lead Teva. And we’re looking around the world for this individual who has strong pharmaceutical experience, is a leader, understands the complex situations, has a great deal of integrity, corporate responsibility, et cetera. And the one thing that I’m surprised about, to be very honest about it, is the quality of people that we are talking with. The senior leaders, the ones with experience, I’m very happy with. So again, this takes some time, but I’m very encouraged in terms of who we are talking to.

Gregg Gilbert

Analyst

Great.

Yitzhak Peterburg

Analyst

So regarding – hi, Gregg, it’s Yitzhak.

Gregg Gilbert

Analyst

Hi.

Yitzhak Peterburg

Analyst

So regarding your second question, those are the main, exactly as we said, including some other assets. Some of them are only financial assets and real estate assets, and very small other assets. I don’t think we need to go through it. The main two assets we identified really undergoing as we speak. And as I said, we hope to finalize it during this year. On the third question about generic, I ask Dipankar if you can comment. Thank you.

Dipankar Bhattacharjee

Analyst

Yes. Good morning, Gregg. Regarding the U.S. new product launches, as we described before, we are targeting more than 80 different product opportunities that are expected to yield between 40 and 50 launches this year. When we look at the breakdown of all these opportunities, the products where we have a high level of confidence in our ability to launch them this year due to a clear position from legal, regulatory, and operational readiness, these are expected to generate approximately $500 million. Our ability to generate additional sales beyond the $500 million is the degree of success we achieve from the basket where there is a higher level of risk related to legal, regulatory, and operational readiness, as well as the competitive environment. It is the breadth and the depth of our generics pipeline that provides us with these numerous opportunities, or as we have said in the past, more shots at goal every year. And regarding the timing of launches, as you know, most of our 2017 launches are in the second half of the year.

Gregg Gilbert

Analyst

Thanks.

Operator

Operator

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

Jami Rubin

Analyst

Thank you. Just a couple. Sol, just back to the CEO search. I think I asked this question before, I don’t know that I got any answer, but would you be willing to waive the requirement for a CEO to live in Israel? And the second question is you said that $1 billion of the $5 billion of debt repayment this year will come from the divestitures. Would incremental asset sale proceeds beyond the $1 billion accelerate debt repayment, or will there be other uses of proceeds? And just my final question, Eyal, to you, just – I didn’t completely understand the explanation of the drivers of gross margin deterioration this quarter. Can you explain that again? Thanks very much.

Sol Barer

Analyst

Okay. So this is Sol Barer. I’ll answer the first question with respect to the CEO. As I indicated, Jami, we are looking around the world for the absolute best candidate for Teva. We are committed, once we find that candidate, to bring that candidate to Teva and we will do what it takes to make that happen. Okay, to be very clear about that.

Jami Rubin

Analyst

Okay, thanks.

Eyal Desheh

Analyst

Okay. So first of all, you asked about acceleration. Yes, we would like to pay down debt faster and de-lever the balance sheet. Regarding drivers of gross margin, compared to Q1 last year, this is a different company. We have the Anda business which comes – it’s a distribution business, naturally with a much lower margin than our other businesses, both the generic and the specialty. And we have divested the UK piece. That has a small impact, but it came with very nice profitability. And of course we’ve talked a lot about the impact of Venezuela which basically – the profit completely disappeared and there is zero profit on $21 million of sales in the results of Q1. So the impact of all these drivers has reduced the gross margin to where we are today. It could improve a little bit later on this year with new launches of generic products, but this is the area, it could be a bit better.

Jami Rubin

Analyst

Can you just – a quick follow up. We thought you had said about $900 million in new product sales this year. Did you bring that down? I just want to make sure I heard that right. And I guess to what extent has pricing pressure in the business paid or had an impact on your gross margins?

Sol Barer

Analyst

Dipankar, new product sale.

Dipankar Bhattacharjee

Analyst

Yeah. Our new product sales, we had even in earlier conversation spoke about 80 different product opportunities. That basket still remains the same.

Jami Rubin

Analyst

Did you give us a total number? I may have misheard you, but I thought you had given us a total number of $900 million, just want to square that with what you’re saying today?

Dipankar Bhattacharjee

Analyst

No, I don’t believe so.

Eyal Desheh

Analyst

No, it was not $900 million.

Jami Rubin

Analyst

Okay, thanks.

Eyal Desheh

Analyst

The second one, Jami, on the pricing pressure, it did not have an impact on our gross margin. I think we said in the prepared remarks, the gross profit margin of our U.S. business or U.S. Generic business remains exactly the same, it’s around 55% or a bit higher and did not suffer – was not impacted by pricing pressure in generics in Q1.

Jami Rubin

Analyst

Okay. Thank you.

Operator

Operator

Thank you. Your next question comes from the line of Andrew Finkelstein. Please ask your question.

Andrew Finkelstein

Analyst

Hi, good morning. Thanks for taking the question. First off, just in fourth quarter, there were some one-time income from a deal with Takeda in Japan, just curious if there were any proceeds from transactions like that in the current quarter? And then if you could talk at all just about what you’re seeing from the FDA in terms of improving the predictability of reviews for complex generics since there’s a number of them that are a potentially meaningful swing factor in your second half results?

Yitzhak Peterburg

Analyst

So in Q4, we included $150 million of sales from Ninlaro product to Takeda. This quarter, we grew to $75 million from the same source.

Andrew Finkelstein

Analyst

But no other transactions like that?

Yitzhak Peterburg

Analyst

Yeah.

Eyal Desheh

Analyst

No.

Yitzhak Peterburg

Analyst

No?

Hafrun Fridriksdottir

Analyst

Hi, good morning. This is Hafrun speaking. So with regards to working with FDA and seeing some improvement in the time lines there especially for complex generics, we are clearly seeing much more activity from FDA than we saw in the past. And we had been working very closely with them on some of the complex generics, which we have filed over the last few years. So clearly, we’re seeing improvements there.

Andrew Finkelstein

Analyst

Okay, thanks very much.

Operator

Operator

Thank you. Your next question comes from the line of Douglas Tsao. Please ask your question.

Morgan Williams

Analyst

Hi, this is Morgan Williams on for Doug. So I was just hoping, I have a few questions. Number one, number of competitors said that the consolidation in the customer base is beneficial to a large manufacturer of generics. Are you seeing the same dynamics? Just asking for some more color around your commentary on generic performance this quarter. And then secondly, I was just hoping you can maybe provide a little bit more background on the AUSTEDO launch strategy and more on your rationale for pricing the product at a discount to competitors?

Dipankar Bhattacharjee

Analyst

Yes. So first, let me take the question that you raised on customer consolidation. So while customer consolidation does raise some pressure on some of our generics manufacturers, we also see opportunities to increase our strategic partnership with our key customers. So our unique global reach, our broad portfolio, and our deep R&D capability to bring a pipeline of new products will create strategic value for both us as well as our customers.

Eyal Desheh

Analyst

And on the question on AUSTEDO, so you heard from Yitzhak, we’re really very pleased with the initial feedback from the market. There is a very good reaction from both patients, physicians and also payers. As you also know, we are developing this product and are awaiting an approval in tardive dyskinesia. So we’ve priced it to really meet with both ends of the spectrum in Huntington’s and in tardive dyskinesia. And we really believe that with this we have an incredibly good value for all stakeholders and initial feedback really confirms this.

Michael Hayden

Analyst

Also just to add one, Michael here, why this is being so well received by both patients as well as physicians is the impact of this drug. Chorea really incapacitates these patients. This has major effect on chorea, also impacts swallowing and improves nutrition. And these are well recognized as major impact, without the side effects that you see with tetrabenazine. So overall, an excellent safety and efficacy profile for this product.

Morgan Williams

Analyst

Okay, thank you.

Operator

Operator

Thank you. Your next question comes from the line of David Amsellem. Please ask your question.

David Amsellem

Analyst

Thanks. So just first on divestitures. Just expanding on some of the earlier questions. So what’s the rationale for keeping the U.S. Oncology business, but just divesting the European Oncology business only bearing in mind that you don’t really have a pipeline in oncology? So that’s number one. And then second, anything new to say on the EpiPen generic and what are your expectations there? Thank you.

Rob Koremans

Analyst

Hi. This is Rob. Happy to talk about the U.S. Oncology business. It’s a very important business for us. Bendeka is really doing extremely well with almost a 98% conversion and doing extremely well there. We have an important deal with Celltrion where we will be launching in 2018 and 2019 two biosimilars, so this really is a very important business and it fits perfectly with us. For Europe, what we see is it’s different. We have a different portfolio in Europe than in the U.S. and we just don’t have enough of the pipeline to be able to feed neither the oncology products itself and it’s also the pain products in there and we believe that someone else could be a better owner, and it would definitely help to decrease our dips there. So we’ve taken the decision to try and divest this, but the onco business for us, with the opportunity for the Celltrion products, is really important going forward.

Hafrun Fridriksdottir

Analyst

So comment on EpiPen. So this probably remains to be a top priority for Teva. And this is one of the product which we are working very closely with the FDA on. We still see a meaningful opportunity for a true AB-rated generic here. And as a reminder, we have a settlement agreement with Mylan, which allow us to launch upon approval of our ANDA. The outlook for this product has not changed from prior statements, so we are targeting an early launch in early 2018.

David Amsellem

Analyst

Thank you.

Operator

Operator

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

Ronny Gal

Analyst

Good morning. And thank you for taking my question. Actually, I’m going to try to sneak in three. The first one is about cost-reduction. Eyal, how should we expect the operating line to progress during the year? You had a one-time benefit on SG&A this quarter, but if we kind of think about quarters two, three or four, should we just from the outside seek ongoing reduction on those operating lines or should they be in absolute numbers, roughly flat. Second, the issue of selling respiratory, you seem to have a little bit of air to breathe here with Advair through generics being delayed. This looks like it’s a contractual sale to the PBMs or the big buyers. Can you tell us where you stand on this? And essentially, when should we begin to see contribution for this product, is it this year or only in the 2018 contracts? And last, to Sol, I guess, as a representative of the board, some of the discussion we’re having here on the investment side is whether dividend should be suspended for a couple of years to bring down the debt level. And obviously you guys had to struggle with this question as well. Is this something that you will consider under any circumstances? Or is this something that you’ve essentially rejected in an absolute sense?

Eyal Desheh

Analyst

Hi, Ronny. Good morning. So on cost reduction, we’re progressing very well, a little better than already pretty ambitious plans. So we are seeing the results. The company has reduced head count by almost 5,000 employees since we closed the transaction with Actavis on August 2, and about 1,700 from the beginning of this year and the impact of that will be seen later on this year. It never happens on Q1 when people leave. We are also reducing expenses in the areas which are not headcount or cost of labor related, more efficiencies of cost of goods sold. So all this is going to be seen as the plan progresses throughout the year and will improve our operating margin. We said it and I’ll repeat it again. This is not a linear year. The second half is expected also to benefit from more launches of our new program mostly coming from the U.S. Generic, and the combination of both will improve the margin.

Sol Barer

Analyst

This is Sol. I’m sorry, go ahead.

Hafrun Fridriksdottir

Analyst

On your second question, we’ve actually started being active in the market just recently with the sales forces. Key would be, as you indicated, the payers, and to really get on the right formulary access will take some time. The recent news, today’s news on – or actually yesterday’s news on Hikma will help. I think also payers to see that what we have is a very attractive offering, but we will only start to see real sales early quarter three for AirDuo RespiClick. And it’s an experiment we’re doing. I think it’s a good new innovative strategy, but it will not have an immediate ramp up as we need to really make sure that we get formulary access.

Ronny Gal

Analyst

Sorry, go ahead.

Sol Barer

Analyst

In terms of the dividend, as indicated, our policy hasn’t changed and as Eyal has mentioned, every quarter we as a board evaluate paying the dividend. And obviously, this quarter we have said that we will pay the dividend. I can’t speculate under any circumstances what would happen. I think it should suffice at this point that our policies are the same and that we have met and we have paid a dividend, and in the future every quarter we will do the same.

Ronny Gal

Analyst

Thank you.

Operator

Operator

Thank you. Your next question comes from the line of Umer Raffat. Please ask your question.

Umer Raffat

Analyst

Hi, thank you so much for taking my questions. I have a few today, if I may. First, Dipankar, on generics, so you’re tracking at guidance-like numbers, but at a lower margin. So I want to understand how you’re thinking about the strategy in generics. Is it a revenue number you’re working towards or an operating profit number? On specialty maybe for Michael, Michael, are you expecting the quarterly CGRP to work? And if so, can you deliver it in a way which doesn’t involve three separate injections every three months? And then finally, for Eyal and Michael, I noticed your slide says your net debt-to-EBITDA this quarter was 4.49x, and I also recall that your covenant requires you to be at 4.25x, so I just wanted to reconcile those two. And finally, I also want to push back a bit on counting Ninlaro as revenues. Thank you.

Dipankar Bhattacharjee

Analyst

Thanks, Umer. Regarding the generics question that you asked, we do look at a combination of both revenues and our margins and not one or the other. Regarding the revenues, it’s obviously a combination of what we see happening in our base business in the U.S., our new product launches that our strong R&D capabilities bring. And also we look at a combination of how our business moves within the U.S. and non-U.S. because from a revenue standpoint, you do have to recall and remember that about 55% of our generics revenue comes from outside the U.S. In terms of what we would expect and how we would track for the rest of the year, we would expect the current levels of price erosion that we have spoken about will remain for the rest of the year. It is embedded in our forecast. And our new product launch revenues, as I mentioned earlier in one of the questions, is we continue to look at that basket and we continue to look at the 40 to 50 launch opportunities that we have.

Michael Hayden

Analyst

Thank you, Umer, for the question on fremanezumab. We’re obviously optimistic about quarterly injection. We’re the only company that actually is looking at both monthly and quarterly. And the reason we’re having some optimism is the long half-life of this particular product that we’ve seen before with very low immunogenicity. So we’re exploring this. We expect to have the results of this before the end of June, and we will be able to see whether a quarterly dose injected just quarterly would be sufficient to have the impact. We also note that our efficacy in the Phase 2 was the best in the class. And so that also, together with the long half-life and low immunogenicity, gives us some optimism. But data will be available for us to really assess this in the very near future.

Eyal Desheh

Analyst

Umer, regarding the covenants, the requirement right now is 5.25x, so at 4.49x we are way below that. By year end, it will go to 4.25x, and we see no problems or issue to comply with that. Next question?

Operator

Operator

Thank you. Your next question comes from the line of David Risinger. Please ask your question.

David Risinger

Analyst

Yes, thanks very much. Good morning, everyone, and congrats, Eyal, and best of luck to you. I have a couple of questions.

Eyal Desheh

Analyst

Thank you.

David Risinger

Analyst

First, with respect to the $200 million in additional cost savings this year, is that a full year benefit to 2017 guidance? Second, with respect to the new product launches in 2017, I wasn’t quite clear on that. Could you restate what amount of new product launch revenue you expect in 2017 in the U.S. and globally? And then finally, with respect to the CGRP, Michael, could you just update us on the Phase 3 readout timing and the timing of filing in the U.S. and EU? Thank you.

Eyal Desheh

Analyst

Thank you, David, for your kind words. The additional $200 million in cost savings are included in our guidance. They’re not in addition to the guidance. We reiterated the guidance, we reiterated the range. This will help us to be within the range in face of some challenges that Yitzhak has mentioned in his introduction, so we can just take that and add it.

Michael Hayden

Analyst

Thanks for the question, David. With regard to results, as I said, we’re expecting the results of CGRP for both chronic and episodic migraine before the end of June. We plan to file for the FDA before the end of 2017, so this is a little earlier than we had stated previously. This reflects the fact that the trial is ending a little early because of the very rapid recruitment that occurred both for chronic as well as for episodic. Just to remind you, of course, also, this program also is using – this is using CGRP antagonist as add-on therapy, so we’re getting a lot of the real-world scenario evidence, which will provide a very unique piece of information that will yield great value to doctors and this will be important. And so we’re expecting to be, depending on when Amgen files second in episodic and potentially first for chronic, depending on Amgen submission dates.

David Risinger

Analyst

And you’ll release your press release in June, the data?

Michael Hayden

Analyst

The moment we have top-line results, this will be press released before the end of June.

David Risinger

Analyst

Okay, thank you.

Dipankar Bhattacharjee

Analyst

I’ll take the question on the new product launch revenues for generics. And I will repeat what I had said earlier is that the number that I said was specific to our U.S. new product launches and we continue to look at our basket of 80 different product opportunities. They should yield between what we expect as 40 to 50 launches, products where we have a high certainty because of clearance on legal, regulatory, and our operational readiness. Will we expect to bring approximately $500 million of revenue? We do have a higher risk basket, which has higher risks around legal and regulatory and our ability to go beyond the $500 million and to the extent we can, will depend on how we overcome these regulatory and legal and operational readiness barrier. But these are revenues and new product launches that are specific to the U.S. We also have a substantial business outside of the U.S. which also has new product revenues which I did not allude to. But they will add to the $500 million that we have.

David Risinger

Analyst

Thank you.

Operator

Operator

Thank you. Your next question comes from the line of Liav Abraham. Please ask your question.

Liav Abraham

Analyst

Good morning. Just a couple of questions here. Firstly, for Eyal, given the cash flow in the first quarter, I know you did make comments on the trajectory of cash flow throughout the remainder of the year. But can you just confirm that you are also reaffirming your cash flow guidance for the year of $5.7 billion to $6.1 billion? Secondly, and apologies for flogging a dead horse here. I know the question has been asked a few times, but my understanding is that in the past you guided to $850 million of new product launches in the U.S. Are you no longer guiding to that number? Is it $500 million plus the option for an additional $350 million more? I just want to make sure on that. And again, apologies, I know, it’s been asked. And then lastly, just a follow on question, your covenants. There continues to be concern from investors on meeting your covenants over – and the covenant progression over the next couple of years. Would you consider renegotiating these in order to provide yourselves and perhaps the investment community with some more confidence and breathing room. Thank you.

Eyal Desheh

Analyst

Yeah. So maybe I’ll take the first and the third question, and then Dipankar would address the second one. So, yes, we are reaffirming the cash flow guidance. And as I mentioned on the call, Q1 has a very unusual large number of one-time cash related events that we don’t expect to repeat later on this year. But I also said and I repeat that, that the year is not linear on business performance and cash flow alike and the second half will be stronger than the first. Regarding our covenants, we see no need to renegotiate or negotiate the covenants. We believe that we’ll meet them in the near and the long term.

Liav Abraham

Analyst

And apologies from my end, just on the second question I asked on the generics. I think you guided to $750 million in the U.S. earlier at Q4 earnings, not $850 million. So I just wanted to clarify that.

Dipankar Bhattacharjee

Analyst

Yeah. So thank you Liav. So again, I will reiterate what I have said and how it relates to the number that you mentioned is that, that in the basket of products that we have, the ones that we have a very high certainty of launching because of clearances that we have from a legal and IP standpoint in the U.S. amounts to $500 million, right. Beyond that there are a number of opportunities that we continue to look at, okay, which has higher risks around legal and regulatory barriers, and our ability to get closer to the number that you’re speaking about is the degree of success that we have in overcoming those.

Yitzhak Peterburg

Analyst

And I want to make sure that we never said $850 million.

Liav Abraham

Analyst

Correct. I said $750 million. I corrected myself, apologies for that.

Operator

Operator

Thank you. Your next question comes from the line of Vamil Divan. Please ask your question.

Vamil Divan

Analyst

Great. Thanks for taking the questions. Just one on the pipeline and then one back on the financials. You mentioned laquinimod and the disappointing data there for RRMS, but you’re continuing still on PPMS and also Huntington’s. I’m just curious of any updated thoughts in those two indications and your expectations are now lower for the products succeeding there? And then I just got a couple of emails here, so I just want to clarify also. You mentioned the added synergies you think you’ll get from Actavis this year and presumably that’s a boost to your full year outlook. What is sort of the offsets that’s kind of keeping your full year outlook the same? Is it more of the FX in Venezuela, is there other factors, is it the margins? What’s sort of leading to the outlook to remaining the same despite that added synergies? Thanks.

Michael Hayden

Analyst

Thank you, Vamil, Michael here. Just to give a quick update on laquinimod. Of course, we were disappointed with the failure to achieve the primary endpoint which just confirm disease progression. But we were interested in the secondary results, which showed a 40% decrease in brain atrophy, a 28% decrease in time-to-first relapse, and also a 25% decrease in relapse rate. So this confirmed the neuroprotective effect of laquinimod and as such, the study on progressive MS, which is a disease much more progressive to brain atrophy, we’re expecting those results in the third quarter. And the Huntington’s study, which is ongoing, will continue to a readout next year. The reason we’re continuing is that certainly we’ve seen the neuroprotective effect, there’s data from other studies, we understand the mechanism and these studies are in full progress, fully recruited, and so this will be continued to the endpoint. Of course, progressive MS, I think we have lower expectations based on the results in relapsing-remitting.

Operator

Operator

Thank you. Your final question comes from the line of Chris Schott. Please ask your question.

Chris Schott

Analyst

Great. Thanks very much for the question. Just one coming back on generic gross margins. I think the earlier comments you said that we could think about some modest improvements from these Q1 levels as the year progressed. Can you elaborate a little bit about longer-term trends on margins? Where do you see generic gross margins moving longer term given some of the adjustments we had with the Venezuela business, et cetera? My second question was on the three businesses that you’re looking to divest. Can you just help us a little bit in terms of the size and the profitability of those business? I know you break out the Women’s Health sales. Can you give us the sales on the EU Oncology and Pain franchises? And how do we think about margins for those businesses, I guess should we think about margins in line with your overall specialty franchise, should we think about just what could happen with the P&L as those potentially go away? Thanks so much.

Eyal Desheh

Analyst

Hi, Chris. So gross margin on generic, we expect that to go back to the level that we’ve seen in the past few quarter, 48%, 49% later on this year. This is based on both higher-margin products that we intend to sell, launching new product that always come with higher margin and of course, cost-reduction improvement from the other side, both of them are going to improve. Gross margin and operating profit margin that we expected will be around 29%, 30% for the year to complement the higher gross margin that we will experience later on.

Chris Schott

Analyst

And just a quick follow-up, 29% to 30%, is that a good run rate going forward, or can you give us a little bit of thoughts about just as we think about the longer-term progression of generics, is that a good run rate, or should that continue to improve over time?

Eyal Desheh

Analyst

Yeah. I don’t want to talk to the much longer term, but when we’re talking about 2017, these are the run rate that we assume.

Chris Schott

Analyst

Thank you.

Rob Koremans

Analyst

And Chris, this is Rob. On your question to the Women’s Health business, it’s about $516 million in revenues and has a very good and healthy contribution. And the same is true for the Onco Pain in Europe. That’s about $360 million in revenues in 2016 and again, very, very contribution margin. So should be very attractive assets to divest and notably on the Women’s Health. This is a business that doesn’t strongly depend on R&D impact and it’s very sustainable products and I think a new buyer will really also benefit from them.

Chris Schott

Analyst

Thank you.

Yitzhak Peterburg

Analyst

Okay. So I want to thank all of you for your participation. See you most probably in the next quarter. Good luck everybody. Good morning.

Operator

Operator

Thank you. That does conclude our conference for today. Thank you for participating. You may all now disconnect.