Oct 31, 2013
Executives
Eyal Desheh - Acting President and CEO Richard Egosi - Group EVP, CLO and Company Secretary Michael Hayden - President, Global Research and Development, CSO Allan Oberman - President and CEO of Teva Americas Generics Robert Koremans - President and CEO, Teva Europe Designate Dipankar Bhattacharjee - President, CEO, Generics Europe Itzhak Krinsky - Chairman of Teva Japan, Chairman of Teva South Korea and Head of Business Development Asia Pacific Judith Vardi - President and CEO of Teva EMIA and Asia Pacific Paul Sekhri - Group EVP, Global Business Development and Chief Strategy Officer Jon Congleton - SVP and General Manager, Global CNS Kevin Mannix - VP, Head of Global IR
Analysts
Gregg Gilbert - Bank of America Merrill Lynch Ken Cacciatore - Cowen & Company Aaron Gal - Sanford Bernstein David Maris – BMO Capital Markets Tim Chiang - CRT Capital Group David Buck - Buckingham Research Jami Rubin - Goldman Sachs & Co. Andrew Finkelstein - Susquehanna Financial Marc Goodman - UBS Liav Abraham - Citigroup Global Markets Inc.
David Risinger - Morgan Stanley Elliot Wilbur - Needham & Company Jason Gerberry - Leerink Swann, LLC David Amsellem - Piper Jaffray & Co
Operator
Welcome to the Teva Pharmaceuticals Q3 2013 Conference Call. My name is Adriane, and I’ll be your operator for today's call.
At this time, all participants are in a listen-only mode. Later we’ll conduct a question-and-answer session.
Please note that this conference is being recorded. I’ll now turn the call over to Kevin Mannix, Head of Global Investor Relations.
Please go ahead.
Kevin Mannix
Thank you, operator. Good morning and good afternoon, everyone.
Thank you for joining us today to review Teva’s third quarter 2013 earnings results. I’m joined today by our acting President and CEO, Eyal Desheh, and the Teva Management Team.
Eyal will begin by providing an overview of the highlights from the quarter, with some additional details on our consolidated financial results. We will then open the call for a question-and-answer period, which will run until approximately 10:00 AM Eastern Time.
Before we start, I’d like to remind you that our discussions during the conference call will include forward-looking statements. Actual results could differ materially from those projected in the forward-looking statements, as a result of foreign currency translation effects, macroeconomic trends, interruptions in our supply chain and other factors that could cause actual results to differ as discussed in Teva's report on Form 20-F and Form 6-K.
Also we’re presenting non-GAAP data, which excludes the amortization of purchased intangible assets, costs related to certain regulatory actions, inventory step-up, legal settlements and reserves and impairment and related tax effects. These are amounts we cannot predict at this point.
As mentioned in the past, we present these non-GAAP figures to show you how, we, the management team and our Board of Directors look at our financial data. With that, I’ll now turn the call over to Eyal.
Eyal, if you would please?
Eyal Desheh
Thank you very much Kevin. Good morning and good afternoon, everyone.
I’m pleased that you could join us today to discuss our financial results for the third quarter of 2013 and I’m happy to have here with me at our corporate headquarters in Israel or on the conference line the entire Teva Executive Management Team. This time and due to the special circumstances, I will provide prepared remarks for both the CEO and the CFO and not next time.
But I’m happy to inform you that Kobi Altman, Senior Vice President and CFO of Teva Americas was nominated as acting CFO for Teva. I plan to take you through our quarter highlights as well as the details of our financial results and I’m aware that you may still have question regarding yesterday announcement and call.
To date we’ve made significant progress in implementing the strategy that we’re (technical difficulty) at the end of last year. We will continue to focus our efforts on our generic and specialty business and core R&D programs including the high value complex generics and (technical difficulty) as well as expanding our presence in emerging markets and broadening our portfolio.
We will divest non-core assets and increase organizational effectiveness through our cost reduction program to ensure Teva’s growth and its role as a leader in the never changing pharmaceutical industry -- the ever changing pharmaceutical industry. Our R&D team has made tremendous advancement throughout the year as many of you know we initiated our Teva In-Focus Webinar Series in early October to inform and update the investment community on the progress of our R&D program.
This new communication initiative provides an in depth view of Teva’s R&D strategy and progress in primary therapeutic areas. We successfully kicked off the series with a review of our respiratory franchise earlier this month.
We hope that you’ll join us for our next webinar on our NPE program, which will be held in early December by Dr. Michael Hayden.
Today we’ve developed 13 and we’ve approved 13 NPEs for development. I’ll now provide you with an overview of the third quarter results.
Overall, the financial results were in line without expectations -- our expectations compared to the same quarter in 2012 and increased sequentially with revenues of $5.1 billion and non-GAAP EPS of $1.27per share. During this quarter our generic business continued to benefit from a more selective strategy to retain our leadership position while focusing our efforts on long-term sustainable profitable growth.
Our U.S. Generic business had revenues growing 6% year-over-year to $1.1 billion, mainly as a result of the exclusive launch of Niacin where in the course of a weekend we enabled 30,000 pharmacies around the country to dispense this important generic product.
Another important launch this quarter was the launch of the generic equivalent of Temodar. We were particularly excited to learn about the court’s decision from yesterday into the budesonide case.
We now expect to have at least three to 12 more months of exclusivity in the U.S. market and possibly as long as through 2019.
We also benefited this quarter from good performance of our specialty business growing 3% compared to the third quarter of 2012 to $2.1 billion, primarily driven by our women's health, oncology, respiratory and Parkinson's franchise. COPAXONE continued to lead the U.S.
and global relapsing-remitting MS markets in both sales and market share. We are pleased to see that COPAXONE maintained total prescription share leadership and captured new prescription share leadership, despite increasing competition in the MS markets.
In the U.S., sales increased by 3% compared to the third quarter of 2012 and in Europe we recorded record sales with a 17% increase over the comparable quarter of 2012. We believe that COPAXONE well established clinical experience and unsurpassed 20 years efficacy and safety profile is an extremely unpredictable -- in an extremely unpredictable disease will continue as a primary treatment option for physicians and patients.
Additionally, we are excited about a possibility of providing an alternative therapeutic options for patients with relapsing, remitting MS. Teva filed with the U.S FDA the three time weekly dosing of COPAXONE 40 milligrams one milliliter and we anticipate FDA action in the first quarter of 2014.
Our OTC joint venture with Procter & Gamble continues to show strong results across all regions with 13% growth in the third quarter of 2013 compared to the same period in 2012, with strong sales in Europe, Middle East and Africa and Asia. Our overall OTC business continue to progress well and deliver another quarter of double-digit growth compared to last year.
These positive were offset by softer sales of the generic business in Europe as a result of our continued strategic focus on profitable and sustainable growth and lower sales of API in that regions. Also declining somewhat with our business in the rest of the world which was negatively affected this quarter by foreign exchange fluctuation, most in the Japanese yen as well as from the impact of timing of COPAXONE tenders in Russia.
Before moving on to other financial highlights of the third quarter, I’d like to mention that adjustment -- the adjustment we made this quarter to our GAAP results which amounted to $361 million. The majority of this adjustment relate to amortization of purchase intangible assets and impairment charges mainly of in-process R&D of Nuvigil.
Let me briefly touch now on several additional highlights of our financial performance this quarter. Our non-GAAP gross profit margin was 58% in the quarter, compared to 58.6% in the third quarter of 2012, resulting primarily from decreased inventory level which were down from $180 million net of foreign exchange and higher level of inventory write-off of finished goods.
Our net non-GAAP R&D expenses were $348 million this quarter or 6.9% of revenue, an increase from $319 million or 6.4% of revenues in the third quarter of 2012, reflecting primarily the increased activity and new progress made by our global R&D organization. Our non-GAAP selling and marketing expenses were up 6.4% year-over-year to $961 million mainly in relation to certain of our specialty and OTC medicine.
G&A expenses remained stable compared to the third quarter of 2012 at $297 million or 5.9% of revenue. Teva’s non-GAAP operating profit this quarter was approximately $1.3 billion, down 5% compared to the third quarter of 2012 mainly as a result of higher R&D and sales and marketing spending.
The overall split of operating profit before G&A expenses between our main lines of business for the quarter is as follows, global generics 25%, multiple sclerosis 49%, other specialty brands 22%, OTC and other businesses at 4%. Our non- GAAP financial expenses in the quarter were slightly down to $71 million.
The provision for tax in the quarter was lower compared to the third quarter of 2012 and amounted to $185 million. Our non-GAAP annual tax rate for 2013 is expected to be 14.5%, higher compared to that of 2012 mainly attributed to the mix of products we sell in the geographies we sell in offset by tax benefits from planned mergers of certain subsidiaries.
We expect tax rate for next year to increase to approximately 20% mostly due to the changes in the tax environment in Israel. Our cash flow from operation and free cash flow in the third quarter of 2013 were negatively affected by the payment of previously announced legal settlement.
Excluding the effect of this payments cash flow from operation and free cash flow were solid at $1.3 billion and $856 million respectively. Including the settlement, we recorded cash flow from operations of $444 million and negative free cash flow of $34 million.
In its meeting this week, the Board has approved its quarterly dividend for the third quarter of NIS1.15 per share. Based on the exchange rate on October 29, 2013 of the shekel to the U.S.
dollar, this translates into approximately $0.33 per share or a total amount of $276 million. Looking forward to the rest of 2013 we are narrowing our previously provided guidance range and now expect to end the year with revenues between $19.7 billion and $20.3 billion and non-GAAP diluted earnings per share of $4.95 to $5.05.
These days we're busy completing our planning process for 2014 and look forward to sharing with you our guidance for the year in early December. In closing I would like to iterate that our Board and leadership team are fully committed to the implementation of several strategies including the development of new compounds, making strategic acquisitions, forming joint venture and planned acceleration of the company's cost reduction program.
I have utmost confidence in all my colleagues at Teva management team and in our devoted employees to help drive this company forward and make it a success story. I look forward to providing you more information in the future on the progress we will be making on all fronts.
Thank you very much. I will now turn the call back over to the operator who will open it up for questions and answers.
Operator, please.
Operator
Thank you. We'll now begin the question-and-answer session.
(Operator Instructions). We have Gregg Gilbert from Bank of America online with a question, please go ahead.
Gregg Gilbert - Bank of America Merrill Lynch
Yes, hi. Good morning.
Good afternoon. I have three quick ones to ask upfront.
Eyal, given the importance of generic Pulmicort to the U.S. generic lines and obviously that was good news yesterday; can you give us annualized sales and relative gross margins for that product?
Secondly, when will you launch the liquid TREANDA form and will you discontinue the current form at some point? And third is for Dr.
Hayden if he's there. Was wondering if Dr.
Levin's departure affects your commitment to the company and seeing through the R&D strategy overall? Thanks a lot.
Eyal Desheh
Okay. Thanks Gregg.
Regarding the Pulmicort and budesonide [ph], I will leave some more details to Allan Oberman who heads our Americas business. This is more or less a $700 million product for us as you know from both information provided in the past, the gross margin is high but the operating margin is influenced by a high level of royalties that we share with AstraZeneca.
Allan, do you want to add please.
Allan Oberman
Thank you, Eyal. You've covered it well.
I would just add that we're very pleased with yesterday's decision. It solidifies us for the balance of the year as we talked over many of our earnings calls and that cloud should now be behind us.
And we see as we look forward we expect at least 3 to 12 more months of exclusivity with a possibility of extending beyond that to 2019. So it was a very, very good decision for Teva and for the U.S.
generics business yesterday.
Eyal Desheh
Thank you, Allan. Michael, please provide the answer on TREANDA.
Michael Hayden
Thank you, Gregg. We are – let me just deal with the more personal one first.
Just to say that I feel deeply privileged to be the head of R&D and President of R&D of Teva. I am extremely grateful to Dr.
Levin and for initiating that recruitment and through the Board of Directors for recruiting that. As I am enabled to implement the strategy fully, I will remain fully present in every aspect with all aspects of my commitment to fulfill a strategy that I believe in that encompasses uniquely in the industry the strength of generics and branded and the NTEs in our selected therapeutic areas.
So my commitment to the strategy hasn't changed. I remain grateful and appreciative to Dr.
Levin for everything he's done. But with the strategy in place, I remain fully committed to enable this and to do everything in my power to move us forward in a way that's appropriate for the strategy that we have.
Gregg Gilbert - Bank of America Merrill Lynch
Thanks.
Eyal Desheh
And the TREANDA question, the liquid TREANDA.
Allan Oberman
Do you want to comment on that, Rob?
Robert Koremans
I'm happy to do it, Allan. So first of all the TREANDA is performing tremendously well in its current form, right?
We're enjoying the 15% growth with TREANDA as it is and it's really well positioned and doing well. We have the registration for a liquid and currently in process of evaluating the optimal timing, the supply commitment and also our inventory to transition, but TREANDA as it is today in its lyophilized powder form is really a fantastic product.
So we're carefully evaluating it and we'll be able to tell you a bit more in the weeks ahead.
Gregg Gilbert - Bank of America Merrill Lynch
Thank you.
Operator
We have Ken Cacciatore with Cowen & Company online with a question, please go ahead.
Ken Cacciatore - Cowen & Company
Hi. Thank you.
Eyal, can you clarify your comments on tax rate going forward, a little bit more clarity and just a repeat on what you gave us? And then also I didn't know if Dr.
Frost was on the line, I'll let you answer the first one and you can let us know if Dr. Frost is on.
I have a question for him. Thanks.
Eyal Desheh
No, Dr. Frost is not on the line.
This is the management call as we always do the quarterly call. Regarding tax rate, our tax rate this year is between 14% and 15% as we have guided and that's what we see next year.
And we've seen the government here in Israel increase the taxes including a program [ph] enterprise and special lower tax for cooperation. It went up to 9% here.
That will have a fortunate impact on our average tax rate with good increase to about 20% in 2014. Just one comment; that depends a lot on performance of COPAXONE [indiscernible] average under the assumption that COPAXONE generic about 20% and non-generic COPAXONE in 2014 could lower this.
Ken Cacciatore - Cowen & Company
Okay. And then maybe you could just pass along to Dr.
Frost, I understand it's a management call, but shareholders yesterday were quite frustrated with an inability to understand kind of climbing of the CEO search and really is definition of the type of candidate. So if there's some way he can clarify that for us in the future, that would be helpful.
Thank you.
Eyal Desheh
Well, I could try. The Board was very clear.
The Board deposited this company in my hands and the hands of my management team. And we will manage the company, drive it forward according to the strategy that was designed together with Dr.
Jeremy Levin and we're all committed to that. The timing of selecting a permanent CEO is completely at the hand of the Board.
Ken Cacciatore - Cowen & Company
Thank you.
Operator
We have Chris Schott from JPMorgan online with a question, please go ahead.
Chris Schott - JPMorgan
Great. Thanks very much.
Just had two here. First, can you talk about the impact of channel consolidation to your generic pricing and generic gross profits in light of some of the transactions we've seen most recently in the cash and as we've gone through this year?
The second question was coming back to a topic yesterday. I guess I'm just trying to understand how much of a priority business development is for Teva in this period of time when the company's is doing its CEO search.
It just seems that there is risk that you could do another deal that doesn't fit the strategic focus that the next CEO of the company decides upon. I just want to understand a little bit about how you think about that dynamic and it seems like as you're rebuilding this pipeline, business development was a key piece of that story and I'm just trying to see how you're balancing the need to move that pipeline forward and broaden it compared to a strategy that may seem very similar to what we see today but also might be different than what we're hearing today.
Thanks very much.
Eyal Desheh
All right. Thank you, Chris.
I’ll start with BD and I’ll let also Paul, who’s sitting here next to me to elaborate. It should be very clear, business development is a major strategic arm compared to Teva.
The Board is expecting us to bring business development deals to the table that will continue to build the pipeline and will continue to expand our presence in emerging markets, and to conduct collaboration with other industry players. So, this is not being put on hold.
If anybody is incinerating that this will go forward as fast as it has before and Paul can talk about a long list of opportunities that the agency and we see we’re now developing and are having on the table. Paul.
Paul Sekhri
Yeah, thanks Eyal. I think Eyal said it, but just to elaborate just a little bit, I think that we are very clear on our strategy as Eyal mentioned and we intend to broaden our pipeline along with working in here with Michael and his team, but looking at beyond previous type of M&A transactions now to JV is the strategic collaboration looking into emerging markets and also licensing deals in order to execute as I said on the strategy that we’ve communicated.
Eyal Desheh
Thanks, Paul. On the channel consolidation, Allan maybe you can provide some -- shed some light on what's happening, and Dipankar could also add some information in Europe.
Allan, please.
Allan Oberman
Great, well thank you for the question, Chris. The most recent announcement by McKesson creates more of a global channel consolidation and a regional channel consolidation.
And this one, McKesson is already the largest player in North American, both U.S. and Canada, and now takes the majority stake in Celesio.
This is more of a wholesaler footprint expansion and clearly as the worlds leading generic player and a very strong specialty pharmaceutical contributor, we see potential as our customers consolidate globally to work with them. On previous calls and previous conversations we talked about the last year’s event, the Walgreens, Alliance Boots and ABC consolidation.
And that one had more of a vertical integration associated with it both from a pharmacy channel perspective as well as the distribution perspective. And what we can say is, we continue to work with Walgreens, Alliance Boots, ABC as they continue their integration.
And we continue to benefit as being an industry leader in working with them relative to our size and scale. Specifically with regards to Celesio maybe I’ll turn it over to Dipankar, and Dipankar can offer some European perspectives on Celesio.
Dipankar Bhattacharjee
Thank you, Allan. As far as our European perspective of general consolidation is concerned, we already had deep and broad relationships with most of the players involved and who have been named in transactions over the past year.
We see this consolidation as a positive development. If you look at our generics, commercial presence in Europe, we have multi-country presence, and leadership positions number one in about 11 markets and number two or three in another 10 markets.
We have a very broad portfolio and as this consolidation deepens we expect to benefit from this consolidation as being one of the largest, if not the largest supplier to most of them in most markets.
Operator
And we have Ronny Gal from Sanford Bernstein on line with the question. Please go ahead.
Aaron Gal - Sanford Bernstein
Good morning and thank you for taking my question. I have two, first regarding the generic business; I understand you’re now focusing more on profitability.
Can you help us understand if this business is profitable today and how more profitable it is versus last year that is, if we think about the profitability of this business should we think about operating profit as 5%, it's 10%, it's 15%, just kind of like a ballpark figure how profitable that business is? And second to Michael; I have two questions, first regarding Mesoblast, I think they’ve released a press release yesterday, but with press release out saying that they were clear to conduct their Phase III trial, should we expect that trial to start soon and roughly how will they influence the cost of R&D.
And second, there’s a new wave of methodological, biological compounds coming in. I was wondering how you saw the influence of those products on Treanda?
Eyal Desheh
Thank you. Dipankar, will you take the question on Europe please.
Dipankar Bhattacharjee
Yes. Thank you, Eyal.
Thanks, Ronny. As far as the European business is concerned in terms of profitability for generic, the answer is very clearly yes.
The business is a profitable business. There are some business units and countries which are obviously more profitable than others.
We do extremely well in markets which are branded generics markets as far as markets which are more mature where the generics penetration is higher and most prescriptions are driven on an INN basis. We continue to remain focused on improving our profitability.
Our strategy which we have been executing for the last year and half, we believe that the evidence that we see now is paying results. We continue to focus on profitable and sustainable business.
We have selectively participated in tenders, but in most part where tenders are not profitable or sustainable, we have selected not to participate in them. And in terms of our market leadership we have continued to maintain our market leadership, and I believe the scale that the market leadership offers puts that at a competitive advantage to continue to improve our profitability from where it is.
We have very clear goals set and we are delivering on those goals.
Aaron Gal - Sanford Bernstein
Anything, can you give us some sort of quantification of this, so it's very hard from the outside to see that level of profit. It's a pretty big business on the revenue line, but we have no idea how much it contributes to Teva’s earning.
Can you just give us a feel for it as mostly, as one of your competitors have decided to exit that market because it's not profitable enough; can you give us the feel?
Eyal Desheh
Yeah, I can give you. The operating margin of our generic business in Europe is approximately 15%.
Aaron Gal - Sanford Bernstein
Right. And where was it like a year ago since you’re improving your profitability.
How is the timeline closing?
Eyal Desheh
Actually it grew when compared to last year.
Aaron Gal - Sanford Bernstein
All right. Thank you very much.
Michael Hayden
Okay, Ronny, just in answer to your question, yes we’re delighted that the FDA has approved the IND for the -- essentially the self therapy for cardiac failure. This approval just came in.
Essentially the trial is a Phase III trial with and importantly an interim analysis. The interim analysis will be done after about a 125 patients, and will help determine whether there is a reason to continue the trial, in other words particularly such that its efficacy has likely to be achieved in the broader Phase III trial.
That is committed to the first phase of the trial, and we look forward to enrolling the first few patients in this trial in the very near future. I think the other question was on G-CSF, and we're going to be launching …
Aaron Gal - Sanford Bernstein
It was not on G-CSF, it was Treanda and the impact of the new generation of biological drugs on that franchise?
Michael Hayden
Well, I think as we look to Treanda, I mean we’re, it's still a franchise we did very well and we’re looking to maintain that competition, we are looking also to expand indications. And Rob, would you like to comment further on the market for Treanda relative to introduction of other products?
Robert Koremans
Yeah, pleasure Michael. So, obviously we’re following it closely and in the [ph] CLL, there might be some erosion towards the end of next year.
It's really too early to tell, but like I said before Treanda is performing fantastically today and the product’s continues to offer fantastic value to patients at the moment.
Aaron Gal - Sanford Bernstein
Thank you very much.
Operator
And we have David Maris with BMO Capital Markets on line with the question. Please go ahead.
David Maris – BMO Capital Markets
Good morning, Eyal. It's my understanding that the company is heading on the road to meet with some investors shortly and given that you can’t meet with everyone, is there anything yesterday that was said that you think shouldn’t have been said or maybe said in a different way.
Anything that, any criticisms that you’ve seen in the press or in reports or from investors that have called you, that has -- it's either been surprisingly off pace or something that it is surprising but valid, and the management needs to consider? Is there -- maybe what do you intent to tell people, investors when you meet with them and they lodge these complaints to you?
Eyal Desheh
First of all, yes, I do plan to get on the road, meet or talk with investors, with analysts and have a dialogue from Teva. I think that there are many things that they're not and they should have tried to provide information and explain.
Looking at the performance of the stock price yesterday, I mean you don't have to be a financial genius to understand in the market we're unhappy. I think the market is looking for Teva for stability.
The market is looking for performance. Long-term assured performance, not just the strategy but also execution and this is what I and my entire management team here intend to give you.
David Maris – BMO Capital Markets
Okay. But there was nothing yesterday on reflection overnight that you said, well, I wish we had done this differently or you know what, this criticism, that's a new one.
We really should think about that.
Eyal Desheh
Well, there were probably a number of advices that we listened to very carefully and we'll definitely evaluate, listen to everything and learn from mistakes made. Nobody that is doing things is immune from making mistakes.
We all know that. But if you made one, you might as well learn from it and this is what we're going to do.
David Maris – BMO Capital Markets
Thank you very much.
Eyal Desheh
You're welcome.
Operator
And we have Tim Chiang from CRT Capital online with a question, please go ahead.
Tim Chiang - CRT Capital Group
Hi. Thanks.
I had a follow-up question on the COPAXONE. What are you guys doing in terms of looking at possibly filing a citizens' petition to the FDA?
Have you guys considered it or are you guys still considering that pathway to request additional clinical trials to be run for any generic?
Eyal Desheh
I'll ask Michael to answer that…
Michael Hayden
Well, thank you for that important question. The data that we have now recently published on COPAXONE is extremely interesting, maybe somewhat surprising in that when you actually compare the COPAXONE, the branded COPAXONE with some of the generics and we've now looked at a few, what you see is they really appear to have very different biological effects on the pathways of inflammation that we know COPAXONE works on.
COPAXONE does all the right things. It up regulates pathways that are protective and it down regulates pathways that are injurious.
And we have published now in current opinion and of therapeutics showing how purported generic actually do different things and sometimes the opposite. So this really highlights the complexity of COPAXONE as a molecule.
We welcome all advances and even products that may compete with COPAXONE that are of interest of patients and what our primary objective is, is to make sure that patients have no harm. But with molecules that look quite different than the biological effect, we have to question whether these are truly generic.
And one way to really show that there is no harm is to develop appropriate approaches to clinical trials that provide reassurance to the community that these drugs really are appropriate and will have the desired effects for the patient's health. So we're continuing to do additional work.
We're continuing to look at additional – the generics themselves actually have different patents relative to each other, so we're finding complexity that is unexpected. It's providing further data on the mechanism or action of COPAXONE itself which is very interesting, but I think it's much more complex than just the making of a single generic for COPAXONE.
Richard Egosi
Maybe one more comment to complete the answer on the citizens' petition, whether all this will be in the form of a citizens' petition or not is yet to be seen and [indiscernible].
Tim Chiang - CRT Capital Group
Okay, great. Thanks.
Operator
We have David Buck from Buckingham Research online with a question, please go ahead.
David Buck - Buckingham Research
Yes. Thanks for taking the question.
A couple of quick ones for you, Eyal, and then maybe a follow-up for Michael. Eyal, can you talk a little bit about – with Pulmicort looking like it's more of a certainty and just keeping the exclusive generic status for next year, the overhang or the negatives to account for our guidance seem to be obviously COPAXONE your view there and tax rate.
Is there anything else that we should be thinking about for 2014 as a key risk factor? And can you talk a little bit about the calls on cash flow that you have for 2014?
And then just for Michael Hayden, Dr. Hayden, if the evidence has been so compelling on COPAXONE, you've obviously had a citizen petition process in the past.
Why do you think the agency hasn't concluded that there is a need for more of a clinical trial approach to safety? What's been the sticking point in getting them to agree with that?
Thanks.
Eyal Desheh
Let me take the first one. First of all on Pulmicort what we said before is that we believe that we had exclusivity at least three months but between 3 and 12 months.
So entire 2015 is not 100% protected and the court might have a different ruling that could impact the results and this is something that we should keep in mind. The major unknown for next year is a generic entry for COPAXONE.
Well, currently the court decision will allow a generic entry of May 2015. You heard Michael just a minute ago regarding that whether the generic versions are [indiscernible] what the impacts would be on the human body of an MS patient, I think that debate is definitely one that we'll be conducting during the next few months.
So in order to have a generic version in the market, FDA we'll have to approve it and we will have to wait and see if that happens or not. So it is question mark in our mind and everybody's mind something that we'll have access as we go along.
We will provide guidance for 2014 but we will definitely give you our version of what could happen if COPAXONE will become generic and what could be the impact in order to help you access the sales and profit for next year in different models [ph]. We're working on this right now and we'll get new information every day.
And I'm sure there will continue to be new information during 2014 about this very big question and to our business model. Regarding tax rate, as I said, the COPAXONE in generic that will have negative impact to the tax rate because it is generating profit with the tax lowered and we'll get a generic in May next year, tax rate will be in the neighborhood of 20%.
Operator
We have Jami Rubin from Goldman Sachs online with a question, please go ahead.
Jami Rubin - Goldman Sachs & Co.
Can you hear me? Okay, sorry about that.
Eyal, a question for you. How do you plan to hit your guidance for gross profit margins for the generic drug business?
I believe it was 45% to 47% when so far for the year I think you're well below that, around 40%. So how do you get to 45% to 47% for the full year?
Thanks.
Eyal Desheh
[Indiscernible] and then I will get the gross profit question.
Allan Oberman
Thank you for that very interesting and provocative question on what the agency might be doing and of course I can't comment on what the agency would be thinking about. Clearly the agency will be taken into account all the information that's available to us.
We have not seen any conclusion from that and of course in all of that in just benefit and analysis, we look forward to learning more as we get closer.
Eyal Desheh
The question on gross profit, the reason for our lower gross profit is in fact second quarter actually has to deal with our cost reduction and efficiency program and with the reduction of this inventory which was down significantly this quarter when something like this happens, and it is a good thing. Don’t get me wrong, because it's an excellent thing for the longer term of the P&L performance, but there are (technical difficulty) there are more production expenses on the P&L rather than the balance sheet (technical difficulty).
We are also writing down inventory. This is mostly all of this is in the generic space, not in the specialty.
So it is impacting the generic gross profit that comes so far this year lower than our original guidance report, and we’re writing off in inventory in order to reduce inventory levels at the market, finished goods at the warehouses to adjust to the quality requirement and we expect this is part of what you’ve seen during the years impacting gross profit. Thankfully we managed to composite with that, with other operating expenses so the impact on our bottom line was (technical difficulty).
Jami Rubin - Goldman Sachs & Co.
Eyal, are you sticking with the guidance set for the full-year of 45% to 47% and how do you get there? How do you make up for it in the first quarter?
Eyal Desheh
No, that will not happen this year.
Jami Rubin - Goldman Sachs & Co.
You bet it will not happen this year. Okay, thank you.
Operator
And we have Andrew Finkelstein on line with the question. Please go ahead.
Andrew Finkelstein - Susquehanna Financial
Thanks very much. Can you talk at all about trends in some of the emerging markets in particular Russia, you noted the timing of tenders and there have also been some headlines about supplies into that market place.
In general your views on any regulatory changes affecting various markets around the world and how generic substitution is likely to evolve as you think about your forecast. And then with COPAXONE on the commercial side, if you could talk it all about how you’re seeing the market in the U.S.
of all the instance some of the new competition and where you’re finding the most royalty versus the most pressure within the physician community. Thanks.
Eyal Desheh
Okay, I’ll ask Judith Vardi, who is heading our EMIA and Asia region to respond to the emerging market question, and then Rob Koremans will provide the answer on COPAXONE and the dynamics that we see in the U.S. market.
Judith Vardi
Okay. Hello, everybody.
Russia is a strategic important market thus far. We're committed there to the market, to the patient, to the -- we continue to provide usual all product to the market and it is the timing of the tender offered to us last year, the tender last year was in Q3, this year it's happening in Q4 and we’re (indiscernible) for that.
And in Q3 compared to last year we had a significant increase in our branded generic business, so our business is growing there, the branded generics (technical difficulty).
Eyal Desheh
And to Rob on the U.S. generics market and the competitive environment.
Robert Koremans
My pleasure, Eyal. So the COPAXONE is really holding its ground extremely well.
We’ve seen a little bit of very slight loss of total prescription volumes in say 12 months ago. But in reality what we’ve seen especially in the last two, three months is that COPAXONE is leading the new prescription in the market.
We continue to see the patients, doctors like value the unsurpassed efficacy and safety profile of COPAXONE and it will be more than 20 years of experience with this product. So yes, there is an inner market from the oral therapies, but we are very happy to report and be able to report that COPAXONE is really holding it fantastically.
And if you coupled it with, and we’re excited to be able to bring a new improved version to the market for next year where three times weekly 40mg all the feedback we’re getting from physicians, from payers and patients alike make us quite optimistic about the opportunities for this product as well so actually there is (indiscernible) of COPAXONE so far.
Andrew Finkelstein - Susquehanna Financial
Thanks very much.
Operator
And we have Marc Goodman from UBS on line with the question. Please go ahead.
Marc Goodman - UBS
Yes, you were talking about the generics gross margin and you were mentioning the inventory changes. Can you help us understand what the underlying gross margin is if you excluded all of that, I guess are they one timer’s or maybe they are not one timer’s that way you can understand what the real margin is.
And then second, on COPAXONE, the sales and marketing behind COPAXONE has been a lot less if you look at what you spent relative to what you thought you were going to spend at the beginning of the year, and I was curious why that is and if you’ve learned something from it, I mean I would think that the product has done actually pretty well relative to the competition. And so if you’re planning on taking that spending level down even further assuming you don’t have a generic and then how do we think about how you’re going to spend if you do have a generic?
Thanks.
Eyal Desheh
Okay, regarding the gross margins especially in generic; first of all nothing excluded, it's all included in our non-GAAP, our P&L within our (indiscernible) adjustment and that this is part of an ongoing business of the company. The development of inventory write-off this year is it's higher than before.
It will level down next year, there’s no question about that and we’ll improve the generic profitability. Our entire cost reduction program is designed to improve mostly the profitability of a generic business so most of the cost saving which has to do with the level of inventory, we have, with just capacity to volume of production will a positive impact on the generic business in the next few years.
Marc Goodman - UBS
Before you move to capacity, so if you would not have done these changes to inventories would you have done a gross margin in the generics up 45’ish percent?
Eyal Desheh
Probably. But again with these changes and the improvement, it's something which is taking time.
On COPAXONE, Rob can you please respond?
Robert Koremans
Yeah, pleasure, and Marc thanks for the quarter. The COPAXONE efforts really we will continue our promotional efforts behind COPAXONE to support its leading position.
We have been in that market for 17 years and know exactly how to do it more -- spend most effective and most efficiently and continue to look for efficiency obviously. But going forward beginning of next year expect to be able to bring also the three times weekly 40mg as an alternative for patients, and that’s definitely going to get our full support and definitely going in that phase we will not reduce our spending there, but we try to do it as effective and efficient as possible.
Operator
And we have Liav Abraham from Citi on line with the question. Please go ahead.
Liav Abraham - Citigroup Global Markets Inc.
Good morning, I have two please for Dr. Hayden.
Firstly, on Laquinimod can you comment on your confidence in European approval? And I’d be interested in your thoughts regarding the use of Laquinimod in combination therapy for the treatment of MS.
I noticed that you filed patents with the U.S. PTO for Laquinimod in combination with Tecfidera, Gilenya, COPAXONE and the Interferons, and was wondering whether you’re considering initiating combination trials and when we could expect those to start?
And then secondly on your NTE program you mentioned that you have 13 NTE’s in the program; could you comment on -- in which therapeutic areas these are and can you confirm that conversations with payers regarding reimbursement of these compounds constitute a gating factor for the compounds entering the program? Thanks very much.
Michael Hayden
Thank you, Liav. I must say, I appreciate your accent.
Thank you very much. On Laquinimod we are expecting approval early next year and look forward to that.
Laquinimod looks like a drug that has a very unique mechanism of action protecting neurons in a very unique way for neuroprotection, and the impact on some of the key things that affect patient lives, progression of disease and also a quality of their lives was still having some impact on relapses. So, we’re looking forward to that and we believe Laquinimod has a great future.
Because Laquinimod doesn't have the most profound effect on relapse, it still has a good effect but not as strong as some of the other drugs out there. We also are thinking about combination therapy and of course we're looking at different targets for combination that have complementary mechanisms of action that would provide synergistic effects and we are already without sharing that at this point have some other targets very much in line for combination with the Laquinimod therapy to provide a single – putting it together for MS [ph], bringing multiple mechanisms of action to have major effects on both visibility and high quality of life as well as relapse rate.
Now we'll go to the NTE. I can say we're a little bit ahead of schedule from where we had thought we might be at this stage.
We had 13 NTE approved for development and when we say approved for development, this is a long process. There were 130 NTEs considered and put into the process and for every NTE [indiscernible] which is contact with payers and very intense complex interaction to make sure that this will provides benefits not only just by people at Teva but by people who are really responsible for reimbursing for some of those [indiscernible] all of these NTEs have gone through that particular process and a process that usually takes three to four months for the intended pipeline, additional lab work in an effort to really improve some of the additions but working very commercially early on with payers and other sources of reinvestment for this issue.
Our areas of [indiscernible] we're going to give you a lot more interest but we have spoken about pain, neuropsychiatry, ophthalmology and intra I.V., these are broad areas we're in and I think we invite you to join us in early December when we'll be able to give you in much more detail about the commercialization process, interaction with payers.
Liav Abraham - Citigroup Global Markets Inc
I look forward to that. Thank you.
Operator
We have David Risinger from Morgan Stanley online with a question, please go ahead.
David Risinger - Morgan Stanley
Yes, thanks very much. I have a couple of question please.
First, with respect to your U.S. generic strategy, could you talk about the most important limited competition launches over the next couple of years that we should be looking forward to?
And then, Eyal, can you please comment on EpiPen and your level of confidence in launching a pharmacists substitutable generic that will have the same device as the innovator? And then my second question relates to rationalizing the revenue.
Could you just tell us how far you are along in backing away from unprofitable revenues both in the U.S. and ex-U.S.?
Thank you.
Eyal Desheh
Allan, can you provide [indiscernible]
Allan Oberman
Sure. Thank you, David.
Let's maybe start with the second one which is rationalizing. The word rationalizing leads you to believe there's a massive effort going on and really what we're focused on is product by product.
Individual products where we want to improve our margins in working today with Carlo and his team, in reducing our costs, finding other jurisdictions where we can produce the product at a lower cost. So I would first say there is no massive impact, material impact to the business of rationalization.
It's a tweaking here and there of products that we are working very consciously on to improve our margin. Have we discontinued some products?
Yes, but they are very few and very far between. So I think you should view it more of a margin enhancement strategy than really a massive rationalization strategy.
As we look over the next two years, definitely in the new product launches framed for 2014, 2015, many of our new products are more heavily weighted to 2015. So when we begin to get to talk about guidance, we'll talk about 2014 and what we're doing.
But I would say it's a rather light year relative to the historical years we've had for new product launches. In 2015 EpiPen definitely is on our radar screen.
It's certainly is our goal and our intension and our efforts working with the FDA to gain an approval status that will allow this to be interchangeable at the pharmacy level. But we've also said should that not happen, we will continue to bring that to market and market that product as more of a branded generic product.
But it is our goal, it is our intension and it is our effort with FDA to continue to push forward with an interchangeable EpiPen equivalent.
Operator
We have Elliot Wilbur from Needham & Company online with a question, please go ahead.
Elliot Wilbur - Needham & Company
Thanks. Can you hear me all right?
Hello?
Eyal Desheh
Yes, we can hear you.
Elliot Wilbur - Needham & Company
Thanks. Just a real quick question on TREANDA and the new liquid formulation.
It looks like a company by the name of Eagle Pharmaceuticals has already submitted a 505(b)(2) NDA and you guys filed a lawsuit on the basis of the existing TREANDA IP that's Orange Book listed but I'm not very familiar frankly with the IP around the new liquid formulation, so just wondering what we should be thinking about in terms of the ultimate defensibility of that new formulation? Thanks.
Eyal Desheh
Allan, would you want to take that please?
Allan Oberman
Thanks. I don't think I will comment on pending litigations frankly.
What we should not forget it's the liquid formulation really is a standard that will improve the products for patients handling but not in terms of efficiency or effectiveness, right? So I want to stress really that the current formulation is all really doing well and it's a fantastic product.
I don't want to comment on anything that is in litigation there. But yes, we're aware of Eagle, absolutely.
Eyal Desheh
Operator, the next question please.
Operator
Yes. We have Jason Gerberry from Leerink Swann online with a question, please go ahead.
Jason Gerberry - Leerink Swann, LLC
Great. Thanks for taking the question.
Just specifically follow-up on the tax rate, Eyal, could you comment with a full year of generic COPAXONE and you previously guided to 20% long term in 2017. With a full year generic COPAXONE could that be higher?
It looks like potentially the government increase in tax rate maybe added about 200 basis points to the tax rate, so just kind of curious how to think about that longer term guidance if that's still in effect? And then one question for Dr.
Hayden, the decision to pull the BLA on the pegylated G-CSF product, I was wondering if you can confirm whether there's any data issues there or if it's purely a commercial decision? It seems a little odd given that doctors and payers seem to be more comfortable with pegylated G-CSF, so just kind of wondering what you guys might need to do to get that product to market in late '15 when those patents expire or if you guys are just going with the value graph [ph] in product?
Thanks.
Eyal Desheh
Well, first on the tax with the full year generic, we'll probably be at the same. It's not going to happen in 2013 [indiscernible].
So long term I believe that 20% for the next two or five years is a good number and of course we'll continue to evaluate it. It depends on some product mix, it also depends on tax rate environment which is unpredictable [indiscernible] 20% is pretty much a good number for the next two years.
And just with regards to the G-CSF, as we've spoken about before our short-term G-CSF will be launched in the near future and then we probably also recognize our long-term G-CSF has been approved in Europe. In the U.S.
there were some complex IP issues that we have to look at and it was decided we could best protect our commercial efforts by essentially focusing on demographics and which is what we did, and we believe that this has the best potential to be fully exploited for commercial reasons and also to ease the needs of the U.S. market and the long acting but non-pegylated form in the United States.
Jason Gerberry - Leerink Swann, LLC
So should investors forget about the pegylated version in the United States or is that still potentially an option down the road?
Eyal Desheh
That is still an option. We haven’t -- we still have the option to refile that in the United States and we certainly will continue to evaluate that for future potential commercial opportunities in the near future.
Jason Gerberry - Leerink Swann, LLC
Okay. Thank you.
Operator
And we’ve David Amsellem from Piper Jaffray online with the question. Please go ahead.
David Amsellem - Piper Jaffray & Co
Thanks. I wanted to come back to the MS franchise and Laquinimod combinations in particular, in light of you filing IP on combinations would encompass Laquinimod and then potentially Tecfidera?
There are companies that are developing potential next generation versions of Tecfidera. So are those assets that you’re willing to explore acquiring and how do you think about that as another way to expand or build the presence in orals in the MS space?
Eyal Desheh
Well, thank you for that question. Of course, I couldn’t share with you at this point exactly which products we’re targeting, but I think what I will just reiterate, we’re looking at complementary pathways.
So for example we know how Laquinimod works by decreasing various pathways that decrease the cytokine release in the brain and particular in the part of the brain the nerve cells and particular to astrocytes and microglia and we’re interested with its consequent effects on neuro protection. We are interested in different mechanisms.
So it is all the (indiscernible) you can give me many, we’re interested in obviously different targets, I’m not going to go into them. But these are targets, they’re drugs that are both in the marketed forms as well as preclinical and clinical development that all we look at, and we of course had to look and see how these would be formulated with the drug like Laquinimod and how they be not mutually antagonistic and truly provide synergistic effect.
And just to say we already have a few that we really believe that not only provide additive, but synergy for the benefit of patients.
David Amsellem - Piper Jaffray & Co
Okay. That’s helpful.
Then one other quick question, I don’t if you comment on this earlier, but any update on the Irvine facility and the sale there? Just how should we think about your long-term plans for your generic injectable business?
Eyal Desheh
Yes, first of all the Irvine facility is up for sale. And we’re moving most of our injectable production to Europe at the (indiscernible) facility, in Hungary, (indiscernible) facility in Holland and basically most of our injectable will be produced in Europe.
David Amsellem - Piper Jaffray & Co
Thank you.
Operator
And our last question comes from Louise Chen from Guggenheim Securities. Please go ahead.
Louise, your mic is open.
Unidentified Analyst
Hi. This is (indiscernible) on behalf of Louise.
I was wondering if you can provide an update on your Japanese generic business. What is the penetration of the generic today and where you expect it to be over the next couple of years and also if you can give us a little update on your Latin America generic business as well?
Thank you.
Eyal Desheh
Yes, okay. We are privileged to help you.
Dr. Itzhak Krinsky was -- I think our Japan operations from Tokyo, it's late hour for him.
But Itzhak can you please provide some update?
Itzhak Krinsky
Yes. I think the commitment of the Japanese government to expand the generic use in Japan is there.
I think they’ve set a target of reaching about 60% penetration in terms of volume by 2015. I think we expect some [ph] external incentive to come in April, some incentive with regard to the pharmacist dispensing generics and the like.
So we’re quite optimistic with regard to the growth of the generic market in Japan. I think -- and we’re preparing our self for the increased volumes that we anticipate.
Eyal Desheh
Thank you, Itzhak. Allan can you please provide update on Latin American generics?
Allan Oberman
Sure. Sorry, I just have to get off of mute.
Our Latin American generics business is actually performing extremely well. As I think everyone will remember it’s primarily a branded generics business.
We have market leading positions in three of the major countries in Latin America and we continue to invest in developing our franchises, developing our new products and advancing our growth. So we are very, very bullish on our Latin American business.
I’d say the one thing, we always keep an eye out for is currency and the impact of currency devaluations and we are seeing some of those this year. But the underlying business is extremely healthy and growing extremely well.
Operator
And I’ll now turn the call back over to Eyal Desheh for final remarks.
Eyal Desheh
Thank you very much. So thank you all very much for participating in this call, for listening to this call.
I’d like to especially to thank my colleagues at Teva management for participating. If you would like to talk to our Investor Relations department please call Kevin Mannix or Ran Meir in our U.S.
office. Thank you all.
We’ll talk to you soon.
Operator
Thank you ladies and gentlemen. This concludes today’s conference.
Thank you for participating and you may now disconnect.