Ran Meir - IR
Eyal Desheh - Acting President and CEO
Kobi Altman - Acting CFO
Robert Koremans - President and CEO, Teva Europe Designate
Michael Hayden - President, Global Research and Development, CSO
Dipankar Bhattacharjee - President, CEO, Generics Europe
Allan Oberman - President and CEO of Teva Americas Generics
Teva Pharmaceutical Industries Limited (TEVA) Business Outlook Conference Call December 10, 2013 8:00 AM ET
Good day ladies and gentlemen and welcome to the Teva Pharmaceutical Industry Limited 2014 Business Outlook Conference Call. My name is Glenn and I’ll be your operator for today. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. [Operator Instructions]. As a reminder this call is being recorded for replay purposes.
I would now like to turn the call over to your host for today Mr. Ran Meir. Please proceed.
Thank you, Glenn. Good morning and good afternoon everyone. I am joined today by our acting President and CEO, Eyal Desheh; our acting CFO, Kobi Altman and the Teva management team. Eyal and Kobi will begin by providing our outlook for 2014. We will then open the call for a question-and-answer period, which will run until approximately 9 AM Easter Time.
Before we start, I would like to remind you that our discussion during this conference 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 expense, macroeconomic trends, interruption of our supply chain and other factors as discussed in Teva’s report on Form 20-F and Form 6-K. Also, we are presenting a non-GAAP outlook, which excludes non-recurring items and related tax effects, which 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 will now turn the call over to Eyal. Eyal if you would please.
Thank you, Ran. Good morning and good afternoon everyone. First of all, I would like to express my support to Kevin Mannix, our Head of IR, that you all know who could not attend this call due to an unexpected medical situation in his family. We’re pleased you could join us today to discuss our financial outlook for 2014. We recognize that the release of the 2014 outlook is an important event for Teva and you, our shareholders and analysts following a year of significant change but one of great progress in the implementation and execution of our vision and strategy.
We remain committed to providing greater transparency in order to allow the investment community to better understand our company. With that in mind, I will use my time to today to discuss the key drivers of our next year performance and give you some insight into our approach to providing the outlook for 2014. I will then turn the call over to our acting CFO, Kobi Altman, who will provide additional details around our 2014 outlook.
To-date we’ve made significant progress in implementing the strategy that we outlined at the end of last year. We continue to focus our efforts on our generic business and core R&D program including high value complex generics, promising specialty medicines including NTEs as well as expanding our presence in emerging markets and broadening our portfolio. At the same time, we’re increasing organizational effectiveness through our cost reduction program to ensure Teva’s growth and its role as a leader in the ever changing pharmaceutical industry.
2014 will be a pivotal year and a year of major transition across the Company. During 2014, our product mix is expected to change. We will increase the efficiency of our organization and in particular in generics and OGC. We plan to launch six new specialty medicines and potentially submit another 10 for regulatory approvals, and we will experience change to our tax environment. All of these changes will be addressed in this call.
Looking first at our specialty business and in particular Copaxone; we are preparing for intensified oral competition and possible generic competition which I will touch on in greater detail in a few minutes. This is a franchise that we vigorously defend, both commercially and legally. At the same time we’re preparing for major potential new product launches. Copaxone 40mg in the United States, NERVENTRA the brand name for Laquinimod in Europe, DuoResp or BFC Spiromax in Europe and Adasuve in the United States as well as expanding our Women’s Health portfolio with anticipated launches of Seasonique in Europe and Losartan in the U.S.
We are also continuing to launch our GRANIX our short acting G-CSF in the U.S. and LONQUEX our long acting G-CSF in Europe. During the year we will also reach important milestone in some of our specialty Phase III clinical programs including Reslizumab for acute asthma and Custirsen for prostate cancer. And depending on the outcome of the Phase III trials we expect 10 potential specialty product submissions including one NTE.
Our specialty business strategy brings promising opportunities and we are encouraged by the level of progress we see. These opportunities will begin to pay back in two to three years' time and will require investments in both R&D and prelaunch marketing expenses during this time. It is important to see 2014 as a year of investment in our future while being mindful of the need to demonstrate business continuity and deliver strong year-over-year result. We'll also continue our intensive for additional new pipeline products through our business development program.
Turning to global generic, 2014 will be an important year for our core business. We will continue to focus on efficiency and cost reduction while advancing our value market share in the United States, Europe and the rest of the world. With an eye on the long-term future we continue to invest in development of a complex generic portfolio which we believe will enhance our product offering while further strengthening our profit base and allowing for sustainable profitable growth.
We will also seek out additional opportunities to expand our global footprint and in particular in pharma emerging markets to ensure we are best positioned in high growth markets. We are very excited about the growth prospect of our new therapeutic entities development program. We view these new products as part of our specialty medicine program and many of the new development are in our core areas of expertise of CNS, psychiatry, respiratory and oncology.
We believe that we have the right capability scale, knowledge and people in place to turn this program into a major business driver for Teva. We look to continue the strong growth of our OTC business by continuing PGT healthcare expansions globally and maintain focus on new product launches and business development. Both we and our partner Procter & Gamble are fully committed to our joint venture and very satisfied from its performance. The first two years of the joint venture have been very fruitful allowing us to seize on an impressive opportunity to achieve great results in area of great importance for patients.
Almost two months ago we updated the market on our ongoing cost-reduction program which includes approximately $2 billion in annual cost saving by the end of 2017 compared to the 2012 cost base. We estimate that $1 billion or 50% of the $2 billion annual cost saving will be realized by the end of 2014 and 70% by the end of 2015.
The majority of the savings are expected to come from the reduction in the Company’s cost of goods, procurement and people. As noted in my remarks before, we expect to reinvest part of the initial saving accumulated in 2014 and 2015 in high potential programs. These investments will primarily include a development and go to market of the Company’s [complete] generic and specialty pharmaceutical pipeline which includes more than 30 late stage programs.
Now let me address Copaxone, a possible generic competition to Copaxone in the U.S. is an event whose timing and exact manner of approval, if at all, is beyond our control. We believe that a prudent and safe pass for patients in a chronic and complex disease such as multiple sclerosis will only be achieved through a clinical evidence demonstrating generic sameness.
However as we cannot focus the FDA decisions in this matter, we are left with this major unknown for our 2014 plan. Applying a responsible and transparent approach to our annual planning process around this unknown we have decided to create two annual operating plan scenarios. The first scenario or the exclusive Copaxone scenario assumes no generic competition to Copaxone in 2014 and is expected to reduce our operating profit by $500 million due to overall competition.
Still we estimate that our consolidated financial results for 2014 under this scenario will be similar to 2013 with non-GAAP diluted earnings per share of $4.80 to $5.10. This would be an impressive result given that it would be achieved against a headwind of $800 million reduction in net income resulting from the increased competition to Copaxone, which is made up of a reduction of net income by $450 million and increased taxes which will further reduce net income by $350 million. We achieved these impressive results by implementing a comprehensive cost reduction program and improvement in the performance of almost all other parts of our business.
The second scenario or the generic Copaxone scenario assume generic competition to Copaxone in the U.S. as early as June 1, 2014, in the form of two AB rated competitors which would result in the reduction of Copaxone net profit contribution by approximately additional $500 million or $0.60 per share compared to the scenario where exclusivity is maintained and would bring us to a total non-GAAP diluted earnings per share for the year of $4.20 to $4.50. This represents a total reduction of Copaxone net profit of approximately $1 billion from anticipated 2013 levels.
Kobi will provide more details about the scenarios and assumptions in just a minute. Regardless of which scenario takes place, all of our choices are designed to drive top and bottom line growth into right place and for the long term. We’re committed to realizing the strategy that has been outlined and is well underway throughout Teva. Teva is a leader and we intent to remain leaders in the industry. Our focus must remain strong and steady on the goals we have set for our Company and the critically important roles each business has in achieving these targets.
As part of our strategic approach, Teva will continue to identify opportunities to enhance value and efficiency across our business activities including expansions of our specialty and generic portfolio and pipeline to internal development and business development activity. And as always we will continue to focus on making quality medicines more affordable and accessible to patients around the world. I want to emphasize our conviction and provide reassurance that our strategy is the right plan to build a more sustainable company and lay the foundation for future growth. Our leadership team and all of our employees around the globe will focus on executing an engagement to ensure continuity in achieving our objectives.
Before turning the call to Kobi, I would just like to mention that we’re aware that aside from our outlook from 2014, you would also like to know how quickly a permanent CEO will be in place. I can assure you that this is of a high priority for our Board, and they are operating expeditiously to move this process ahead. And while that work takes place, Teva’s management team and I, are executing the business strategy I have just outlined was great focus and enthusiasm.
I will now turn the call over to Kobi, who will provide additional details about our non-GAAP financial outlook for 2014. Kobi, please.
Thank you, Eyal, and good day everyone. Earlier today we issued a detailed press release of our non-GAAP 2014 financial guidance in order to help everyone understand our outlook for the year. The press release contained quite a bit of important information about the expected performance of our various businesses. So in the interest of time I would like to touch only on several key areas of our financial guidance providing you with some additional color.
Today, we are presenting two scenarios for 2014; a generic Copaxone scenario and an exclusive Copaxone scenario to reflect the different potential outcomes of Copaxone in 2014 due to the uncertainty around generic competition in the United States. It’s important to understand the assumptions we have made in each of those scenarios. In the generic Copaxone scenario, Copaxone revenues in 2014 are expected to decline by about $1.1 billion from 2013. This scenario assumes the two generic competitors we launched an AP rated generic version of Copaxone 12mg in the United States in June 2014, which by year end, would capture approximately 20,000 patients while Teva Copaxone 20mg with approximately 11,000 patients hit the same mark. In addition, we expect to launch Copaxone 40mg in the U.S. by February 2014 with approximately 30,000 patients by the end of May 2014, rising to more than 40,000 patients by year-end.
In the exclusive Copaxone scenario, Copaxone revenues in 2014 are expected to decline by approximately $500 million from 2013. This decline in revenues over 2013 is mainly caused by the intensified overall competition mainly in the U.S. Again, this scenario assumes Copaxone 40mg is launched in the U.S. by February 2014 with approximately 30,000 patients by end of May rising to 40,000 patients by the end of the year.
As a result, we provide two ranges of certain sales and operating expenses figures that are affected by changes in Copaxone sales. It’s important to know that both scenarios assumes launch of Copaxone 40 mg three times a week at the beginning of the 2014 and exclusive sales of generic version of Pulmicort in the U.S. throughout the year. Also our outlook doesn’t include the potential impact of any business development activities. For 2014, we focused total company sales in the range of $19.3 billion to $20.3 billion in the generic Copaxone scenario and $19.8 billion to $20.8 billion in the exclusive Copaxone scenario.
In the U.S., we expect sales of approximately $9.7 billion more or less 49% of total revenues in the generic Copaxone scenario and slightly over $10 billion just over 50% of total revenues in the exclusive Copaxone scenario. In Europe, we expect sales of approximately $6 billion in [13 day ROW rest of world] business are expected to be approximately $4 billion. Looking at our major business lines, we estimate total generic sale which includes sales of API to third parties to be between $9.8 billion to $10.5 billion.
Total specialty products sales are focused at $7.3 billion to $7.7 billion in the generic Copaxone scenario and $7.8 billion to $8.2 billion in the exclusive Copaxone scenario. Total OTC and other sales are expected to be between $2 billion to $2.2 billion which includes net revenues from Teva sharing PGT Healthcare our joint venture with Procter & Gamble of $1 billion to $1.1 billion and approximately $0.2 billion of OTC contract manufacturing in the United States.
The breakdown of our forecasted generic sales is as follows. Total U.S. generic sales in 2013, are expected to be between $4.1 billion and $4.5 billion. Total European generic sales are expected to be between $3.1 billion to $3.5 billion and total rest of world generic sales are expected to be between $2.3 billion to $2.6 billion.
In 2013, we initiated a long term cost reduction program to reshape the way we operate and compete. This program will have a long term impact on our level of expenses and we expect it to result in a $2 billion improvement in our cost base over the next few years compared to the 2012 expense base line. This program will touch all parts of our company including operations, procurement, both raw materials and indirect purchasing, real estate and site maintenance, IT, R&D, marketing materials and activities in all areas of G&A. Cost savings from these programs are included in our current projections. As we prepared to exit 2013, we have already achieved more than $350 million in annual cost savings.
In 2014, we expect to reach $1 billion in annual cost saving. We also expect the majority of that to contribute to our generic business competitiveness in the areas of headcount reduction, production network, [indiscernible] and substantial improved procurement. SG&A will also benefit significantly. As Eyal noted earlier, these cost savings are necessarily to compensate for the expected decline in Copaxone sales as well as the increased investment in our long term future, so our R&D pipeline as well as planned launches of specialty products during 2014 and beyond.
Let’s move on now to discuss profitability and margins, gross margin assuming no generic competition for Copaxone should be approximately 59% of sales. The 2014 gross margin will be affected by the change in the mix of the product lines mainly the gross margin of generic products will range between 41% to 44% in 2014 compared to an estimated 41% in 2013, mainly due to a better mix of portfolio and the cost reduction initiatives. Other specialty products gross margin will range between 83% to 85%. Copaxone gross margin is expected to be between 88% to 91%. Copaxone plays an important role in the Company’s overall tax rate.
Another important topic I would like to touch on, Teva's tax rate projected for 2014 is 22% to 21% in generic Copaxone scenario, 19% to 20% in the exclusive Copaxone scenario substantially higher than the tax rate in 2013 and in previous years, creating $350 million headwind for the Company. The main reasons behind this increase are the increase in tax rate of our Israeli manufactured products, including Copaxone, to 10% from 4% as we move from the now expired incentives regime to the new one. The increase in tax rate on our manufacturers as many of our current tax incentives around the globe are ending the new ones have not contributing yet. The expected generic products mix in the U.S. which is expected to have a large proportion of U.S. developed U.S. manufactured product the profit of which is tax at the relatively high U.S. tax rate.
Taking these and other points I’ve touched on into account I would like to briefly discuss the quarterly progression of our results for 2014 which are expected to be fairly evenly spread. We expect that revenues and gross profit will split equally with income moderately increasing throughout the year from saving and efficiently driven activities offsetting the decline in Copaxone. All of this would result in a better Q1 and Q4 compared to a lower Q2 and Q3.
Foreign exchange rates continue to play a major role in our results as more than 45% of our sales and approximately 60% of our expenses are expected to be recorded and incurred respectively in currencies other than the U.S. dollar. In this plan we estimate a headwind of about $250 million to sales and about $50 million to operating profit from changes in exchange rate compared to 2013. A strong U.S. dollar has a negative impact on both our tops and bottom line though the impact of revenue is much higher than on our operating profit. We continue to take actions to mitigate the bottom line exposures to foreign currencies including taking loans in foreign currencies, euro and Japanese yen, for example, and also in the area of currency hedging.
I would like to address the assumptions regarding major currency rates versus the U.S. dollar in our plan. In this plan we assume the average euro rate to be 128, Israeli shekel at 356, British pound at 1.5, Russian ruble at 32.5, Hungarian forint at 234, Japanese yen at 105 per dollar, and Canadian dollar at 102. Please keep in mind that these guidance are indications only, and actual results may vary whether as a result of foreign exchange differences, market conditions or other factors.
In addition applying current exchange rate to our 2014 plan will have immaterial effect on our estimated operating profit. Our operating cash flow for the year is expected to be around $3 billion in the exclusive Copaxone scenario. This amount is after taking into account approximately $2 billion of payments for legal and tax settlements announced in 2013 as well as payments associated with our cost reduction program. So excluding these one-time items, cash flow from operation will be approximately $5 billion.
In the press release which we published today you would find many more details regarding the composition of our P&L and anticipated ranges of sales and expenses by product lines and geographies. Thank you very much for listening to us this morning, and now we will open the call for Q&A. Operator please proceed.
[Operator Instructions] And our first question comes from the line of Elliot Wilbur. Please proceed.
Just simplistically help me understanding something here. If I add up your absolute spend guidance for R&D, selling and marketing and G&A expense in 2014, I come up with an range of around 6.5 billion to 6.75 billion, which looks roughly equivalent to or slightly ahead of where expense levels on an absolute basis were tracking in 2012 and 2013. So I’m not sure if I am missing something here or perhaps there is just going to be a lot more expense savings concentrated in the COGS line and what I had been expecting but I’m trying to understand sort of why I’m not seeing more of a pronounced impact of the cost reduction programs in those particular line items.
When you look at these numbers and you split them up, what you will see is an increase of our $200 million -- again we’re not providing the final results for 2013 yet but compared to what [surge is tracking] about $200 million to $250 million of increase in sales and marketing expenses, these are associated with the new program, the launches of new product that Rob may elaborate later on are all part of our plans. So we are investing a lot of money in prelaunch marketing and marketing support for the products that we’re bringing to market. The G&A line will probably be about $100 million less than what we’ll spend in 2013. In R&D you should be more or less at the same level.
Okay, then I have one follow-up…
Now to add up to the question yes, these numbers basically include a lot of reduction as you’ve heard in the prepared remarks, at least $700 million of cost reduction throughout the year. Part of that will be of course in cost of goods sold, part of that would be in all other line items, G&A, R&D, and sales and marketing while we are also increasing activities. So our R&D for example, we’re reducing cost. But we are buying many more programs in R&D that Michael can elaborate later on. The place where this net reduction is G&A is set up our $100 million less than in 2013, and all the other lined items were producing more volume, but we're doing it with that money we're doing more R&D activity. We're doing it with the same money. We are doing a lot of sales and marketing activities as compared to 2013 with many new products which we're launching in a number of geographies. This is no longer a U.S. based specialty program anymore but a global one with more cause.
All right, thanks for the detailed response. Then I do have a follow-up question on U.S. generic market as well. I don’t know if Allan is on the line or not, but specifically I just want to ask the question based on some recent data points, it looks like pricing levels or pricing erosion has decelerated pretty significantly over the past couple of months, at least relative to what we've seen maybe in the past 12 to 18 months. So I just wanted to maybe get a little bit of color commentary on sort of what you have embedded in your U.S. generic forecast in terms the expected rate of pricing erosion, and then what some of the swing factors are between the high and low end of the guidance range.
Yes, I am here. Good morning Elliot and thanks for the question. Let me give a broad overview of the U.S. generics view for 2014 which I hope, Elliot will answer your question and if not please remind me at the end. First of all we’re talking about a range that goes from $4.1 billion to $4.5 billion. I think the first thing that is an important factor is our assumption on Pulmicort generic budesonide which Kobi talked about in his presentation. Because of the current litigation, at this point with AstraZeneca we are continuing to assume that we remain a single source generic through the year. So that will have a swing factor if that does not happen.
I think the second important factor is the 2014, I call it a valley or a low year for new products given the historical two years. When you look at the new product flow and the new product opportunities, they’re lower than they’ve been in the past. And some of the high value was concentrated in a rather large product, esomeprazole Nexium, probably the largest brand left to go generic. And we're anticipating a significant number of new competitors in that space and therefore from a value standpoint, not a great deal of value creation. So in the absence of new products, the question you're inherently asking is why do we feel bullish about our generics business, in and around this year's range of 2.13 or slightly ahead of 2013. And the answer is really underscored by the execution of the new strategy that we implemented. First and foremost, looking for pricing opportunity. So yes, we have seen in the last quarter, price erosion slow a little bit from the 5% to 6% range that we’ve experienced over the last 12 to 18 months.
We can’t necessarily predict it or stay low, so we’ve embedded into our plan for next year again a mid-single digit price erosion. But we have offset price erosion and the value of new product tiers to the execution of our value creation based strategy. We have been able to take pricing on a number of products this year and are forecasting next year to recoup some of that price erosion. We are continuing to work on enhancing our margins, both through reshape and formulation of products to lower cost manufacturing jurisdictions or lower cost EPIs. And finally we’ve been working with our large customers to enhance our value creation within and looking to create win-a-win opportunities for growth. So when you put those factors, those upside factors together with the downside factors, we remain relatively confident in the range that we’ve guided, a 4.1 to 4.5.
I think that answered the two part question, Elliot, but if not, I would be happy to delve into anything further.
Elliot Wilbur - Needham & Company
No. I think that covered that, Allan. Thank you for taking that question.
And your next question comes from the line of Greg Gilbert, please proceed.
First on the 40mg, I was curious what supports your confidence on an on-time approval there? And what do you assume happens to pricing on that product in the generic Copaxone scenario. My other question is about Pulmicort generic. Could you quantify the sales and EPS contribution for a year of no additional competition on that product? Thanks a lot.
Rob, maybe you can take the 40mg?
Pleasure Eyal, thanks for the question Greg, so on the 40 milligram why we are quite optimistic is actually because we do extensive market research with both payers, patients and physicians and we see an increased enthusiasm for this product. It's a product that will have the same safety and efficacy and everything that people have come to appreciate for Copaxone 20 but given at a 60% lower injection frequency so that people start to really see this as a very important and valuable products for them to get to market. And based on that we believe that we will be definitely seeing very good uptake of that product when we get it registered, which should happen at the end of January 2014 and we really believe that the product will even do better than in our initial assumptions of 30%-50% uptake, we believe it might even do better than that. The pricing, I'm not going to comment on going for, it's too much of a competitive strategy, I'm not willing to disclose or able to disclose at this moment.
Right, I'm sorry, part of my question what is the confidence on the approvability of the product in late January, is it based on discussions with the agency, just want to make sure you are confident in that time line for launch. Thanks.
So Greg, I could comment on that. This is Michael Hayden, and thank you for that question, we've of course been interacting with the agency around questions around us but we are confident, I would say very confident about the approvability of this product in the timeline that we’ve given you.
Thank you for that.
And Greg regarding the [indiscernible] will be Pulmicort, this will express a generic competition or further generic players in the market, we've been approximately $400 million on certain $100 million on profit that are currently not in the plan.
Unidentified company representative
And assuming it happens January 1st of course, which is very unlikely at this point.
And your next question from the line of Andrew Finkelstein, please proceed.
Maybe you can talk a little bit about the outlook for Copaxone outside the US, what are some of the pushes and pulls in terms of competition, pricing and tenders and various markets that may affect that product and then as we talk about the generics business outside the US, what are some of the factors we should be thinking about there.
Rob, can you please take the first one on ex US Copaxone, and Dipankar on generics in Europe, I can elaborate also about the rest of the world later.
Pleasure, so thanks Andrew, the Copaxone in Europe is actually doing fairly well, we’re seeing at the moment an increased number of patients, low single digit but still an increase ever since we’ve taken over the product back from [Sanofi] really extremely, we're very happy with it, really content with it. Also in ex-Europe and ex USA for instance in Russia we’ve seen a tender come through, it’s always difficult to predict tenders going forward, but actually the majority of business of Copaxone really is in the US and then in Europe and that really makes most of what we’re seeing there, also given by incidence and prevalence of the disease actually this geographical part.
For next year going forward we expect that Copaxone will get a little bit more headwind of the competition in Europe although the rollout of a new product is always slower than what you typically see in the US because of the need to get prices and reimbursement in single countries approved, but for next year we expect more or less 5% of our patients that we expect [indiscernible] to take about a 5% market share at year end of 2014 and that's what we’ve factored in and that's probably the major point in the entire competition. So with the current performance and strong adherence to Copaxone, this is basically, we’re not expecting too much of an impact outside of the US actually and keep more or less the same sales drivers.
Andrew thank you for the question, I will give a few comments on our generic business in Europe, so for 2014, our strategy continues to be to focus on growing in profitable markets, there are number of profitable markets in Europe, many of them are in Southern Europe, we also see the increase in generics penetration, as well as some selected branded generics markets in Western Europe. We will continue to focus on our go to market model and our portfolio in matured INN markets, we are extremely selective about participating in tenders so some of those businesses are businesses we have chosen not to participate in, that will continue to remain our strategy in 2014.
So overall if I can summarize, we see in 2014 we see a low single-digit price erosion in the market in Europe, we see volume growth around mid-single digits and overall we expect a low single-digit growth on our top line in Europe. Overall, the guidance that we are giving today of $3.1 billion to $3.5 billion, we are quite comfortable with our strategy and we are quite comfortable with the guidance for Europe.
Maybe a few more comments on the rest of the world, the rest of the world includes Israel and Canada which are mature market and we expect a very modest growth in these two countries. We expect our business in Japan to improve nicely this year however in Japan or [indiscernible] on the Japanese yen exchange rate will take some of the revenue growth back but we have very little impact on profit, so profitability is going to improve. We see the same thing in Latin America, nice growth in cost on the local currencies assumption on some valuation some of the major currency in Latin America. And then we expect our business in Eastern Europe to continue to grow.
And your next question comes from the line of Ken Cacciatore. Please proceed.
Eyal, just getting back to the costs savings or not, for most businesses repositioning expenses is just a normal course of business, you cut cost somewhere and you invest somewhere else. I’d assume that’s going on in every business every day. So wondering how are we calling or why are we calling these cost savings? We don’t seem to be actually delivering anything to the bottom line.
And then second question would be, can you give some thoughts on growth or not in 2015 assuming generic competition? Will you take more cost down aggressively to ensure either flat earnings or growth in 2015? Thank you.
Okay, let me try to address that. As you’ve heard or you can see from the numbers, we are growing against a headwind of about $800 million of reduction in net income coming from Copaxone in the exclusivity scenario, and of course higher taxes. But still our earnings per share and net income forecast for next year assuming maintaining exclusivity of Copaxone is flat. So if you look at what compensates for that, most of that compensation in sales are also more or less flat were losing about $500 million of Copaxone sales due to oral competition, other parts of the business are growing. Most of that is compensated by cost reduction, and otherwise there should be some magic there. There is no magic. We’re reducing the cost by about $700 million, of course as we always said, we’re investing this year mostly in sales and marketing for the new program and the new launches that we’re planning to submit. We're improving gross profit margin despite the fact that volumes are going up by about 8% volume of generic production.
So if you tear the line item one-by-one, what you see is this is much more than the usual ordinary year of, yes you save some and you spend some. There is significant cost reductions here, there are 1,000 -- close to 5,000 people that we’re going to reduce, this is real money, this is salary it’s about our procurement which is becoming much-much more efficient and you basically -- when you look very closely, you see this in every line item of our business.
Now regarding most cost reduction during the year, our work has not been done yet. And first of all I believe that a Company must become more efficient especially in our generic business regardless the threat of generatizing major products. That of course is another incentive to accelerate the efficiency program and it has been since the middle of this year when we’ll learn about the court decision. So yes we are going to dig even further into our cost structure throughout the year in order to try to speed this up and come even with better cost reduction program that will have a positive impact on our bottom line.
Just wanted to follow-up on 2015, any thoughts on the outlook there even just qualitatively.
First of all, the Copaxone uncertainties will probably remain without and throughout 2015 we hope they will because there will be no generic in 2014 and as you’ve heard us we’re strong believers and the fact that the FDA will have to look at prudential evidence before an approval. So is this likely, yes, it is, would there be later on in 2015, maybe doesn't happen in 2014. These are all hypothetical questions which are very difficult to address by anyone including ourselves.
But to take the generic scenario we believe that we’re seeing more at the bottom in 2014, 2014 could be an improved year further cost reduction, a lot of the activity is taking place this year will have full impact in 2015, because if somebody leaves the Company at the middle of the year towards the end of the year that has little impact but following year it has a full impact. So we do see an improvement in our businesses in 2015. In addition to that the product that we're launching this year with a lot of effort and cost will begin to bear fruits in 2015 and this is more than the ordinary year for product launches. So 2015 should show improvement compared to the base line of 2014.
And your next question comes from the line of Jami Rubin. Please proceed.
Both of your assumptions or both of your scenarios are heavily reliant on a very optimistic scenario for three times week Copaxone. I am wondering if you can -- you talked about numbers of patients you expect that drug to be on. But can you quantify that in terms of the dollar contribution in 2014 and what conversion rate that implies?
Secondly are you planning to launch a generic AG in 2014 and thirdly what rate of erosion are you assuming for your base U.S. Copaxone sales. Thanks.
So to start up with Copaxone 40 conversion, we really expect that when we launch in February by the time of say June we will have 30,000 patients on Copaxone 40. Yearend it's going to be over 40,000 on the Copaxone 40 three times a week. We already said that in the pricing assumptions in the past we were assuming more or less at par pricing but I really don't want to go too much into competitive information on that.
Today in Copaxone, we’re having about 85,000 patients in total. We expect that -- and we see that in the last quarter we lost about 5% in terms of that to the orals, we are still very much leader both in new prescription and in total prescription for Copaxone but still expect for next year that the orals continue to make an inroad in the U.S. And we expect that patient numbers of the orals probably to go up, not only at the cost of Copaxone they will I think we'll probably see more of entry from that switch to Copaxone but still we expect that the orals will be above 100,000 at the end of 2014.
In the scenario where we have no generic competition, we still should have well over 70,000 patients on Copaxone. So that's really something that we continue to see a very good performance of Copaxone in the U.S.
Sorry what was the -- could you remind me of the other question?
Are you launching -- two question, are you launching an AG and erosion rate assumptions for base Copaxone sales.
What I just said for base Copaxone sales, if we have a generic -- you mean when there is a generic on the market?
We expected if they launch in June 2014 that about 25% of the Copaxone will go to a generic but we also expect that the conversion to the three times weekly 40 will continue. So in essence if you look at that by year end there should be around 20,000 patients, that's our assumption in this plan of 20,000 patients will be on a generic Copaxone if and when they make it to the market which is far from certain.
In terms of launching an authorized generic, we continue to monitor it carefully and frankly I am also not willing to disclose our commercial strategy on that. At the moment we believe that the Copaxone is such an important product that this is definitely something that first and foremost we hope to defend Copaxone itself as a brand.
And your next question comes from the line of Tim Cheng. Please proceed.
I know you guys have put a high priority on making decision on a new CEO. I mean is there a hard stop date in terms of when a new CEO will be announced?
Unidentified Company Representative
Thanks for the question. First of all the decision is not ours, I mean, you’re talking to the management. This is the decision that rests with our board. I don’t think that there is a deadline. I know that there is a sense of urgency, but we understand that this is an important decision that will have to be made as soon as possible.
And just a quick follow-up. I think in the press release, you’ve said that there could be at least two AB-rated generic competitors, are you guys aware of more than the two generic filers that the market's aware of that’s the getting into the market on Copaxone?
Yes, I think we’ve said two, not at least two, but Rob would you care to elaborate on that?
Well the planning is that if there is generic there will be two but -- we aware of a third NDA filed for sure and a fourth one potentially there, so there is -- there could be multiple but the evidence is still there that we really believe there should be -- and we have very good scientific reasons to believe this clinical data from patients, right, so whether this happens or not remains to be seen but at the moment there is more than two NDA filings in the U.S.
Ladies and gentlemen as a reminder please limit yourselves to one question and one follow-up question. And the next question comes from the line of Chris Schott. Please proceed.
This is actually [indiscernible] in for Chris. First question just on the cost offsets available to the Company in the event of a generic approval at Copaxone, can you discuss that guidance doesn’t seem to imply any cost offsets there and is that more due to conservatism or just efforts to retain the brand? And then also if you could provide any updated view on what percent of the 2 billion in cost savings by 2017 will ultimately flow through the bottom line once we consider reinvestment that will be helpful as well? Thank you.
The question was about cost offset available in terms of generic Copaxone and the Copaxone model itself. Rob would you care to relate to the sales and marketing around bring your product to market?
Absolutely, so what’s really important in 2014 and that is really the single most important value driver for us is to make sure that we support Copaxone 40 three times a week as good as we can, so we will put our investment level behind that and that is relatively independent from the generics coming to market in 2014. You might see that different in ’15 but in ’14 we really need to make sure that we do everything we can to support the three times a week 40 Copaxone launch.
And regarding 2017 and cost reduction, we plan to reduce our cost base by at least $2 billion by 2017 compared to the end of 2012 when we started this program. If I can estimate and in light of all the moving parts increased volume and production of generic price erosion on generic Copaxone, Copaxone continued to decline due to generic and oral competition and then offset by cost reduction and all additional activities because by 2017, our specialty portfolio and R&D portfolio will look completely different compared to now with many-many more product actually will sell. More revenues at that time will come from products that are currently not in the market that revenue which are in the market after we net off all that I would assume and this is a rough assumption about a quarter of that $2 billion cost reduction won’t stay at the bottom line to improve it.
And you next question comes from the line of [indiscernible]. Please proceed.
Good morning. I have two questions. Firstly Eyal, can you breakout Copaxone and ex-Copaxone EPS for 2014 under both scenarios that you’ve provided?
And then my question is on business development, given the uncertainty going into next year and all the moving parts, I’ll be interested in your thoughts on your ability to executive on any potential deals given all the various -- as I said all the moving parts that generic Copaxone approval of three times weekly et cetera, can we anticipate some business development on your front? Thank you.
Regarding the first question, you have to repeat the second but the first question on Copaxone EPS, we estimate again, these are estimates after taxes and everything else and applying the appropriate G&A to Copaxone which of course is less than it’s proportion to sell. We estimate that Copaxone and the maintaining activities now, we will contribute approximately $2.6 per share and we lose exclusivity, it will be about $2 per share. I mean it’s [$0.67]. Can you please the second question?
Yes my second question was on business development and given all the moving parts and all the uncertainties, your thoughts on business development going into 2014 and your ability to execute on any potential deals over the near term.
I’ll start from the end, I believe that we do have a lot of ability to execute on business development transaction, our strategy right now remains to manage our BD program in order to build our future pipeline either by in-licensing of new molecules or biologics or by acquiring companies that possess such assets in their pipeline of development. This is one part of our business development program. The other part is to expand our footprint in emerging market by making acquisitions of local companies in markets where we believe we don’t have the right presents or criticalness. But this will be mostly the focus of our business development in 2014 but as in business development we’re looking at many other opportunities and though it is hard to tell whether a compelling opportunity that will really create value for shareholders will come to the table, we will look at it, we will not ignore anything.
And you next question comes from the line of Louise Chen. Please proceed.
Thanks for taking my questions. So, first question I had was just under what type of scenarios do you think we could potentially see growth in EPS in 2014 to 2015 and then maybe if you could provide an update on some of your key generic products, Lovaza, TOBI and EpiPen and also G-CSF. Thank you.
The first one, obviously we will see in terms of generic competition immediately end of May beginning of June the ability to demonstrate EPS growth in 2014 compared to 2013 is very limited and this is exactly what our guidance is all about. We do believe that if that happens in 2015 we will be able to demonstrate growth as many other activities and initiatives and new product introduction. In 2014, we’ll deliver much more profits, comes 2015 and beyond.
On EpiPen, all right, there was another question on EpiPen, Allan, would you like to handle that please?
Sure, I think you asked about three products, we’ll start with EpiPen which is rightly as you said 2015 effort midway through the year, we remain confident on that. On Lovaza as you know we won the court case, we’re simply waiting for our regulatory approval and preparing that product and Tobramycin launched in November and we remain in our exclusivity period as we speak in the final product, G-CSF I’m going to kick over to Rob and let Rob handle that one.
The G-CSF we have the short acting G-CSF launched just really recently in the last weeks in the U.S under the name of [indiscernible]. It’s not a generic by the way, it’s really, we developed it as our own product and it has its own right and so far we’re really happy with the launch. The first results are very encouraging but it’s very, very early days, it's really something that will continue throughout 2014 but so far so good. The long acting G-CSF that we have launched in Germany recently and planning to rollout into rest of Europe is called [indiscernible]. Again this is not a biosimilar, but it's something that was developed in its own right with all of the medical evidence needed and also their first results are very good, also very early -- we launched it in November but promising encouraging first signals.
And your next question comes from the line of David Maris. Please proceed.
I ran into [Mike Pierson of Valiant] over the weekend and as you know, he's interested in lot of different areas but one of the areas in particular he’s interesting in is bringing generics to the emerging markets which I think is in part what you’re doing with Procter & Gamble but other than agreeing on price, when not specific to Valiant but a lot of investors have asked about what are the hurdles for, if someone wanted to take over Teva. So, are there any labor deals, tax deals with the government, government takeover or corporate takeover defenses that make it particularly difficult other than our mutual belief that the equity is undervalued?
And then separately a newspaper reported recently that Benny Landa was thinking of taking an activist approach to Teva and some other requirements of the board. Has he been in touch or anyone been in touch recently about changing the board requirements for example of the number of directors or the CEO where you have to be a resident of, anything like that? Thank you.
Thank you David, I'll be happy to talk about obstacles of bringing generic pharmaceutical to emerging markets. I think that, that is the most exciting question of anything you have asked us today, and I believe that the focus that we have in these areas is bearing fruit. I think that the major obstacle is quality in a company with high quality production introducing products in emerging markets with local production of low quality, the quality revolution is yet to arrive in some of the countries, but once it’s there I believe there is an opportunity for Teva and the likes of Teva to grow much further in emerging markets.
Regarding the two other questions you asked me and you asked [indiscernible] well it's not for sale, not about obstacles or barriers or anything of that kind, we have a great plan, we have a great strategy, excellent tools to execute it, very good united management team, wonderful employees and many other assets and the Company will demonstrate that we will execute and will continue to deliver results as we have in the past. Regarding Mr. Landa, I am not aware that he approached the Company. I am reading the paper as much as you do, and there's nothing else I can comment on that.
And your next question comes from the line of Jason Gerberry, please proceed.
Just a quick question on capital allocation priorities in 2014, the previous guidance was for about 4.5 to 5.5 billion in capital allocation, obviously with the guidance of around 3 billion it’s kind of -- can you walk us through the tradeoffs that you're going to make in '14 and company's commitment to the dividend, and then my second question just is on DuoResp what are your expectations in 2014 if you get the centralized approval, could you generate meaningful sales in year one, what are your thoughts in terms of the competitive landscape there, thanks.
Regarding capital allocation and cash on, of course the two are closely related, as we mentioned in the prepared remarks, 2015 is going to suffer from events that happened in 2014 that will have an impact on our cash flow, our cash flow, our natural cash flow run rate is about $5 billion, maybe even a little more, but we do or we are planning expenses that has to do with our restructuring program which is designed to reduce the cost in 2014 and beyond and reduce substantially, that does not come without price.
So we did budget about $900 million of cost associated with restructuring in 2014 and a payment on settlement that we signed in 2013 that will continue throughout 2014. I believe that the following year will already be able to demonstrate our natural run rate of cash flow which is very-very strong.
And now regarding capital allocation, the decision on dividend takes place together with the results of the fourth quarter which will be announced at the beginning of February, it's a Board decision but our sentiment will probably we will see some dividend increase for 2014 and beyond, and regarding buyback, we are always looking at a buyback the good program to return cash to shareholders, and we’ll continue to evaluate cash need and buyback opportunities as we go along.
DuoResp we're really excited about DuoResp for a very simple reason that goes into a competitive landscape of many devices and many extra ingredients in combination. Clearly the most clear and direct competitor will be Symbicort in the Turbohaler from Astra and all of these devices and combinations have one thing in common, that is very low adherence in compliance of patients.
So we know for a fact that around two out of three patients currently are really treated sub-optimally with the current therapeutical options, and with DuoResp Spiromax, we believe that we have a device that is much-much more intuitive and will lead to better compliance and adherence and give real therapeutical advantage to patients and hence we really, real enrichment of the [indiscernible] world therapy. We expect the launch to be around summer of next year and as you well know for Europe the roll out really will be relatively slow because you need pricing reimbursement as I said before for our MS competitors the same is true for us for DuoResp. So in reality '14 is an investment year with relatively low contribution of sales in '14 but beyond '14 this is a franchise that could do -- that we're really excited about and is important for patients, doctors but also for us in terms of commercial reasons.
And our next question comes from the line of David [indiscernible] please proceed.
So if your assumptions for uptake on the three times weekly pharma Copaxone don't pan out in 2014, would you contemplate more aggressive cost cutting next year particularly on the R&D front?
And then secondly regarding R&D, I guess maybe if you can detail what the biggest sources of new spend will be in 2014?
Maybe I'll take the first one and finally allow Michael to answer the second one, he's being waiting patiently. First, we don't like really to address hypothetical questions; we strongly believe in the 40 milligram, we have all the indication that will get approval on time. We have lot of indication from doctors and patients that are waiting for the product. So I believe that our estimates are realistic. Now Michael would you please respond to the second question?
2014 is going to see a significant increase in activity in R&D. We're having about 37% increase in clinical studies. Around 50 Phase 3 trials in R&D, we’re expecting potentially 10 submissions in 2014 and also five potential approvals. So our submission rate has gone up compared to for example 2013, we had four in 2012, we had five. So preparing a large significant expense and investment for us is really getting these submissions, really getting the data ready and 2014 will see a significant increase in submissions more than 2012 and '13 combined. So R&D is growing, it's a very full pipeline with both clinical studies.
We are of course continuing to do our work also to analyze all aspects of Copaxone and have recently published data on Copaxone and also a comparison to generic Copaxone, interestingly there Copaxone [indiscernible] was outlined and documented and evidence provided in terms of gene expression that really paralleled it’s protective effect in terms of inflammation. But this has raised significant concerns also about the generics that don't appear to have the same activity profile relative to the gene expression profile of Copaxone and really raise the question about where they actually have impact not only on the key sales in a negative way but also raise gene expression from monosites which would potentially be pro-inflammatory.
So we're continuing to do work both pre-clinical and clinical, it's a very robust clinical pipeline and over the few years after 2014 we expect the number of submissions to continue to increase. One NTE will also be also be submitted in 2014 and this will continue to grow over time.
And our next question comes from the line of Ronny Gal. Please proceed.
Let's make it interesting one. So I got essentially two components I want to cover. The first one is if I look at your gross margins, they are staying flat from '13 to '14 everywhere except in the generic what goes up an average of 1.5 points, which is equivalent to $150 million. So should we just simple expect that you -- assuming the most of the gross margin improvement that you will make will be swallowed by price decreases and really we are looking at the gross margin, we're looking for in the long term? That is we kind of look at your generic business, is it a profitability we are saying now roughly within 3% to 5%. What we should expect in long term or should we expect this $2 billion to eventually do a much better gross margin from the generic business.
Second if we kind of look at the assumptions you made for Copaxone, you are assuming you will keep about two thirds of a franchise, and what I am worried about is that your competition from the generic side assuming they come in, would simply look at that number and say that's not enough we're going to keep on taking prices down until we get more share and then you will have to match an entire value of the franchise will be lower. Can you just get us more comfort that this will not simply, that you keeping more share will not simply lead to a downward spiral in pricing.
And last, that’s for Michael, I think mentioned Noventa Laquinimod, can you just give us an update about your expectation for CHMP, if you got names, should we just simply assume that we’re now at the level of discussion where you feel pretty confident that the product is coming.
I’ll take the generic gross margin question. First, we are growing in volume and we’re suffering from price erosion, this is going to stay, we do estimate, we do see price erosion trends of slowdown in Europe and in the United State you heard it both from Allan and from Dipankar. So, I believe that at one point in time it won’t take long where all the improvement will go to the bottom line of the generic business. We do see substantial improvement, in next five years when we look at the five years outlook, we do see substantial improvement in margin and profit and profitability of our generic business coming both from the fact that most of the cost reduction and some of it does take time, you shut down a plant and move the entire production to a lower cost location is a process that takes three years so there is more cost reduction to come in our generic business and at the same time profitability will improve because many of our future launches are complex generic through higher profitability, especially higher growth margin and much more sustainability in the market.
So, this is how we see it, we know that many of the cost cutting initiatives that are taking place this year and are not insignificant in total numbers will be even stronger in 2015 when a full year of impact is going to be realized and as we said most of that on the cost of goods sold part most of it is hitting our generic business which we believe is going to improve over the next five year but by a number of percentage points.
Regarding Copaxone generic and pricing policy which we'll probably say there little about Rob would you take that please?
I think what’s really the most important thing we have to do and can do to influence that is make sure that Copaxone 40 comes to market and support that and the enthusiasm for that product is really something that makes us very optimistic that this will be switching most of the patients that currently use Copaxone 20 to 40 which has a patent protection till 2030. So, that’s a very different ball game in that respect and that is really the most important thing we can do.
Second what we really pick up from all of our market research that there is a genuine concern on patients and also from doctors on the quality of a generic defect that this products have not been tested and manned, there is no clinical evidence on safety and efficacy, really is a concern to them. So, I think that will also limit the ability of payers to really influence choices and patients and might really offer something completely different.
So, what we can -- and I doubt that they can overcome that concern but price decreases they will have to overcome that concern really with data and showing their safety and efficacy, right. So, it’s for us the most important thing to do is continue to stay in dialogue as Michael explained before on some of the findings that we have scientific evidences that we have that put questions around the sameness of those circle generics and in commercial, medical and every support we can give to make sure that patients move to or get the chance to use three times a week 40 that really forward going is what we do.
And you would not have to match prices if [indiscernible] take the prices down extra 10%, 20%.
So far for what we’ve seen on all of the discussions with our payers, getting the 40 in there is really more important and I don’t really see that risk there. No.
So, we’re involved in a significant ongoing discussions with the European authorities, if had some questions which we believe we’ve given appropriate answers to, but of course it’s not up to me to define exactly how the European authorities are going to response. So, it’s difficult at this time to give a precise likelihood of approval of Noventa in the very near future. But we remain very confident on the data, on the near protective qualities of this drug and its distinguishing mechanism of action that really offers a lot of hope for decreasing progression of disability and improving synaptic function and protecting against brain atrophy.
And we should still expect CHPN and so one way or the other before the end of the year.
It’s not clear exactly the timing of this and I would say in the near future but exact time before the end of the year wouldn’t be totally certain about that.
At this time we have no further questions. I will now turn the call over to Eyal Desheh, Acting President and CEO for final remarks.
All right, thank you all very much for your participation and for your question. We look forward to talking to all of you and welcome if you have any question of interest in Teva, and I am sure that we will be meeting many of you in the next few months. Thank you all and have a very nice day.
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