Teva Pharmaceuticals (NYSE:TEVA)
Q4 2013 Earnings Conference Call
February 6, 2014, 8:00 a.m. ET
Eyal Desheh - Acting President and CEO
Kobi Altman - Acting CFO
Michael Hayden - Chief Scientific Officer
Allan Oberman - President and CEO, Teva Americas Generics
Rob Koremans - President and CEO, Specialty Medicines
Dipankar Bhattarcharjee - President and CEO, Generics Europe
Kevin Mannix - VP, Head of Global IR
Ken Cacciatore - Cowen & Company
Liav Abraham - Citi
David Maris - BMO Capital Markets
Randall Stanicky - RBC Capital Markets
Corey Davis - National Alliance
Jami Rubin - Goldman Sachs
Elliot Wilbur - Needham & Company
Gregg Gilbert - Bank of America Merrill Lynch
Ronny Gal - Sanford Bernstein
David Amsellem - Piper Jaffray
Welcome to the Teva Pharmaceuticals Q4 2013 conference call. [Operator instructions.] I’ll now turn the call over to Kevin Mannix, vice president and head of global investor relations. Kevin, you may begin.
Thank you, operator. Good morning and good afternoon, everyone. Thank you for joining us today to discuss Teva’s fourth quarter and full year 2013 earnings results. I’m joined today by our acting president and CEO, Eyal Desheh; our acting chief financial officer, Kobi Altman; Dr. Michael Hayden, chief scientific officer; Allan Oberman, president and CEO of Teva Americas Generics Dr. Rob Koremans, president and CEO of specialty medicines; and Dipankar Bhattarcharjee, president and CEO of generics Europe.
Eyal will begin by providing an overview of the highlights from the quarter and full year, followed by Kobi, who will the provide additional details on our consolidated financial results. We will then open the call for a question-and-answer period, which will run until approximately 9:00 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. Factors that could cause actual results to differ are discussed in Teva’s report on Form 20-F and Form 6-K.
Also, we are presenting non-GAAP data, which excludes the amortization of purchased intangible assets, costs related to certain regulatory actions, inventory step-up, legal settlements, reserves and impairment, and related tax effects. These are amounts we cannot predict at this point. We present these non-GAAP figures to show you how 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?
Thank you, Kevin. Good morning and good afternoon, everyone. We are pleased that you could join us today to discuss Teva’s fourth quarter and full year 2013results. I will use my time today to briefly discuss the results of the quarter and year as well as some of the achievements during 2013 before touching on key growth drivers for our future. I will then turn the call over to our acting CFO, Kobi Altman. Who will provide greater detail around our financial results.
Before I begin my review, I would like to remind our listeners that last month Teva announced that Erez Vigodman was appointed president and chief executive officer of Teva effective next Tuesday, February 11. Since 2009, Erez has been a member of Teva’s board of directors and he will remain on the board while serving as CEO.
Erez brings to Teva global leadership, business transformation experience, strong strategic expertise across multiple industries, and deep insight into global market dynamics. Most importantly, he has an excellent understanding of Teva’s pioneering spirit and the challenges we are facing.
Under Erez’s leadership, and together with the management team, we are all committed to delivering medicines and solutions to patients all over the world, and enhancing shareholder value through operational improvements, portfolio optimization, gross margin expansion, strong cash flow generation, and business development activities.
Let me first briefly review the highlights of our financial results. Total revenues in the fourth quarter were $5.4 billion, a 3% increase compared to the fourth quarter of 2012. Our fourth quarter non-GAAP EPS was $1.42 per share, an increase of 8% over 2012. Cash flow from operations before one-time settlement during the quarter were strong, reaching $1.7 billion, with free cash flow of $1.1 billion before settlement.
On an annual basis, total revenue was flat compared to 2012, at $20.3 billion, while non-GAAP EPS was $5.01, down from $5.35 in 2012, following the anticipated loss or decline of several highly profitable products that were sold in the previous year and an increase in sales and marketing and R&D as we continue to invest in our future.
We also had very strong annual cash flow from operations of $5.1 billion and free cash flow of $3 billion before one-time settlements. I am pleased to announce today that Teva’s board of directors decided to increase the company’s quarterly dividend by 5%. This represents a dividend yield of above 3% annually.
Teva will review the possibility of further increasing dividend payments later this year, subject to the outcome of possible generic Copaxone scenarios during 2014. Now, to a further look at 2013.
We did manage to exceed the $20 billion mark in sales we had in our plan and in 2012. However, we reached it with a very different mix of products and geographies than the year before. During 2013, our product mix continued to change as greater revenues and profitability were derived from specialty medicines.
Copaxone delivered another record performance against increase oral competition, exceeding expectation again and maintaining its position as the number one MS therapy for patients globally. We are very pleased with last week’s announcement that the U.S. Food and Drug Administration approved Teva’s supplemental new drug application for three times per week Copaxone 40 mg.
We began shipping products into distribution channels within 24 hours of approval. The visibility of new three times a week Copaxone 40 mg, which maintains the same efficacy and safety profile of daily Copaxone, is a welcome enhancement that offers patients 60% less frequent annual administration, which we believe will improve the overall patient experience.
In addition to Copaxone, we are continuing to drive future opportunities within the existing portfolio. After receiving orphan drug designation, the largest revenue producing product in Teva’s oncology portfolio, Treanda, has extended its regulatory exclusivity to May 2016 for the indolent B cell non-Hodgkin’s leukemia.
We also expanded our global biological oncology portfolio with the launch of short-acting G-CSF in the U.S., Granix, and our long-acting G-CSF in Germany, Lonquex. Revenues from generic medicines including API, were $9.9 billion in 2013, a 5% decrease compared to 2012, mainly due to the termination of our generic Lipitor royalty agreement with Ranbaxy and lower sales of API.
There were several highlights I would like to note. During the year, we launched 388 new generic products globally. In the United States, we had 21 new launches during the year that contributed over $400 million to our top line. Around the globe, we continue to focus on efficiency and cost reduction in our generic business while focusing on value rather than volume.
[unintelligible] to our OTC business and our joint venture with Procter & Gamble, PGT Healthcare, we had exceptional results in 2013, as overall sales of the joint venture grew 15% to more than $1.5 billion following a very strong fourth quarter. Now, looking towards our future, both short and long term, the opportunity lies in our global specialty and generic pipeline, our ability to reduce costs, and a strategic approach to business development.
I will begin with the pipeline. Preparation for new launches are continuing at full speed, with excellent coordination between global, regional, and local levels to ensure that we maximize the asset value.
In addition to the introduction of Copaxone 40 mg, we are preparing for several potential new product launches this year, including DuoResp, or [BSC] Spiromax in Europe, Adasuve and [unintelligible] in the United States as well as expanding our women’s health portfolio with the anticipated launch of Seasonique in Europe. We’re also continuing the launch of Granix, our short acting G-CSF in the U.S. and Lonquex, our long-acting G-CSF in Europe.
2013 was a year of integrating and building Teva’s global R&D organization. While still delivering strong performance in traditional and complex generics, specialty, and [NTE] pipeline, all was accomplished during this year.
Generic R&D delivered 155 submissions in major markets. These submissions included 21 ANDAs in the United States, raising our total pipeline there to 133 pending ANDAs, representing $81 billion of brand value. We believe that 51 of those ANDAs are first to file opportunities representing $40 million in brand value.
In specialty pharma, R&D had another 8 submissions in major markets as part of 30 late stage programs we are running while our NTE approach used 14 projects entering our development pipeline.
During 2014, we will also reach important milestones 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 up to 10 specialty product submissions for regulatory approval, including one NTE.
While we continue to focus our efforts on our core R&D program and go-to-market activities, we are also increasing organizational effectiveness through our cost reduction program to ensure Teva’s growth and its role as the leader in the ever-changing pharmaceutical industry.
During 2013, we updated the market on our ongoing cost reduction program, which includes approximately $2 billion in annual cost savings by the end of 2017, compared to the 2012 cost base. We estimate that $1 billion, or 50% of the $2 billion annual cost savings, 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 increased efficiencies in production, procurement, and people. As we have disclosed, a minimum of $500 million at least will fall into the bottom line, while the remaining amount will be reinvested in the development and launch of our high potential, high growth product, primarily through R&D and sales and marketing expense increase, as well as to offset the increase in costs resulting from the anticipated increases in volumes in our generic business.
I want to assure you that the reinvestment of approximately $1 billion of the aforementioned target into our pipeline and sales and marketing will only happen if the opportunities have significant potential to be viable, durable, and profitable. In the event that one or more of the pipeline opportunities fails to progress or does not fit the criteria just described, that will lead to additional money flowing to the bottom line.
Finally, a word on business development. Our strategy has and continues to emphasize the management of our business for long term sustainable and profitable growth. We intend to use business development as a key driver to build a robust generic and specialty pipeline and portfolio while expanding and extending our geographic footprint, and we are open to any idea which will drive long term value creation.
Any business development opportunity must meet our stringent criteria. It has to have a strategic fit, support our leadership position, and be finally justified and accretive to earnings per share within a reasonable time.
In closing, 2013 was an important year for Teva and its shareholders. Many seeds were planted to ensure our long term success and prosperity. 2014 will be a pivotal year in terms of execution and further enhancement of our strategic direction. We move toward 2014 not only with the necessary determination to execute our plan, but also with firm belief that the important choices we made in the past year are crucial in our journey to a successful future.
I will now turn the call over to Kobi, who will provide additional detail about our financial results for 2013. Kobi, please go ahead.
Thank you, Eyal, and good day, everyone. I’m happy you could join us today to review our financial results for the fourth quarter and full year 2013. We are reporting today strong results for the fourth quarter, which ends a year largely in line with expectations for Teva, despite some tough comparisons to 2012.
Net revenues for the year were $20.3 billion, less compared to 2012, in spite of the anticipated loss of exclusivity on Provigil and certain generic products, primarily [unintelligible] in 2012. This was achieved by strong performance in 2013 of many of our businesses, primarily specialty medicines, led by Copaxone, our U.S. generic business, and our OTC business.
Non-GAAP EPS for 2013 was slightly above the midpoint of our guidance at $5.01, compared to the $5.35 in 2012, a decrease that mainly resulted from the loss of exclusivity from the high margin products that I just mentioned, partially offset by the good performance in other parts of the business.
For the fourth quarter of 2013, we are reporting today a $35.4 billion net revenue and $1.42 in non-GAAP EPS, an increase of 3% and 8% respectively compared to the fourth quarter of 2012. During 2013, we have been working hard to transform Teva to deliver on strategy laid out for the company and to be a more efficient and effective organization. We are making strong progress on all of these fronts, and I will share some of it with you shortly.
Before I dive further into the results of the year and the quarter, I would like to touch on three important issues. First, starting this quarter Teva will report two separate segments in its financial statements. Our two segments are generics and specialty. Why we will maintain the level of granularity of financial information that we provided, there may be some changes in our previous reporting structure and we encourage you to review our full financial statements that we will file in a few days to familiarize yourself with them.
Second, in the fourth quarter we took relatively high one-time charges totaling $825 million after tax, which we adjusted, arriving at our non-GAAP results. These charges, including permits of $329 million, mostly related to plant closure, portfolio optimization, writeoff of IP R&D, and investment writeoffs.
Furthermore, these charges include amortization of purchased intangible assets totaling $330 million, restructuring expenses totaling $104 million related to our ongoing cost reduction program, and additional smaller items. Accordingly, our non-GAAP net income and EPS for the quarter are adjusted to exclude these and certain other items outlined in our press release.
Third, exchange rate differences negatively affect our results this quarter, and for the full year 2013. Compared to the respective period in 2012, these differences reduced our revenue by $49 million this quarter and $166 million for the year, and our operating profit by $45 million this quarter and $129 million for the year.
The reduction in revenues resulted from the weakening of certain currencies, primarily the Japanese yen and Russian ruble, relative to the U.S. dollar. The major impact on our operating income was caused by the strengthening of the Israeli shekel against all currencies.
Let me move on now to discuss some highlights of our financial performance by segment. Revenue from generic medicine including API were $9.9 billion in 2013, a 3% decrease in local currencies terms compared to 2012. This decrease is mainly due to the termination of the agreement concerning [unintelligible] back in 2012 and lower API sales.
Despite this decrease in sales, we continue to strengthen our value market share in the U.S. and key markets in Europe. During the year, we launched 21 generic products in the U.S., 7 of them as first to file or [unintelligible] to file, and 367 new generic products outside the U.S. In the fourth quarter, generic medicine, including API sales, were $2.7 billion, a 1% increase over the fourth quarter of 2012.
In our specialty segment, we had a record year, with sales of $8.4 billion, an increase of 3% compared to 2012. With the exception of the sleep disorder business, where we experienced the anticipated loss of exclusivity on Provigil in 2012, sales of our specialty products increased year over year in all therapeutic areas and in most geographies.
Global revenue from Copaxone in 2013 was at an all-time high of $4.3 billion, an increase of 8% compared to 2012. Despite multiple competitors entering the MS space, Copaxone continues to be the leading MS therapy in the U.S. and globally, and is maintaining its total prescription and new prescription leadership in the U.S.
Finally, to our OTC business, our joint venture with P&G, PGT Healthcare, had another record year in 2013, improving its base business, driving sales force impact, and benefitting from favorable pricing trends.
For the full year, Teva recorded revenues of $1.165 [billion], a significant increase of 26% net of foreign exchange impact, compared to 2012, with gains in all regions. We are very pleased with how PGT Healthcare is progressing and, together with our partners at P&G, are planning for its continued growth.
Turning next to profit margin and operating expenses, non-GAAP gross profit in 2013 was $11.9 billion or 58.6% of revenues, a decrease of $0.2 billion or 0.8% compared to 2012. This decrease was mainly the result of slow revenues of Provigil, which lost its exclusivity, as well as the reduced revenue from additional exclusive generic products, mainly [unintelligible]. These were partially offset by more profitable product mix, mainly in the U.S. generic business, and higher Copaxone revenue as well as early contribution of our cost reduction program.
We are very pleased with the progress our global R&D organization is making on all fronts, specifically in developing our NTE program and broadening our complex generic portfolio. As a reflection of that progress, our non-GAAP net research and development expenses increased in 2013 to $1.4 billion or 7% of revenues, compared to $1.3 billion or 6.3% of revenues, in 2012. We experienced a similar increase quarter over quarter as well.
Throughout 2013, we increased our selling and marketing expenses to support five specialty launches in our growing OTC business as well as prepared for as many as six potential specialty launches in 2014, including the recently launch Copaxone 40 mg.
For the full year, our non-GAAP selling and marketing expenses totaled approximately $4 billion, or 19.9% of revenues, compared to $3.8 billion or 18.9% of revenues in 2012. In the fourth quarter, these expenses totaled $1.1 billion compared to approximately $1 billion in the fourth quarter of 2012.
Our non-GAAP operating profit in 2013 was $5.2 billion compared to $5.7 billion in 2012. This 9% decline is mainly the result of slower sales of exclusive generic and specialty products, mainly Provigil, coupled with higher R&D and sales and marketing expenses. For the fourth quarter, operating profit totaled $1.36 billion, an increase of 1% compared to last year.
For the full year 2013, the overall split of operating profit before G&A expenses between our main lines of business is global generics 29%, MS 50%, other specialty brands 19%, OTC and other businesses, 2%.
Turning now to tax, for the full year 2013, our annual tax rate on a non-GAAP basis was 12.8%, compared to 12.3% in 2012. Our annual tax rate for the year was lower than we initially projected due to several items in 2013 that were not initially forecast, at least not at the prevailing magnitude, which reduced our tax rate for the year, but will not repeat in future years. In particular, our tax rate in Israel on [unintelligible] enterprises increased from 6% to 9%, resulting in a one-time increase in the value of our Israeli tax assets.
During 2013, we have been executing vigorously on our cost reduction program in many areas of the company. We are currently in the process of implementing multiple projects and initiatives in procurement, production and supply chain, [unintelligible] processes, commercial excellence, R&D, and many other areas. All these ongoing projects resulted in an aggregate reduction of our cost base by $426 million compared to the baseline of 2012 year-end, and our total headcount was reduced by approximately 1,000 employees.
We remain strongly committed to delivering on our cost reduction program, and are working towards achieving the $1 billion [unintelligible] and cost reduction target by the end of 2014. Teva continues to generate solid cash flow by strengthening its underlying business and focusing on the right metrics, such as reducing working capital. In the fourth quarter, cash from operations and free cash flow, excluding the one-time payment of certain legal and tax settlements this quarter, were approximately $1.7 billion and $1.1 billion, an increase of 5% and 4% respectively, compared to the fourth quarter of 2012.
For the full year 2013, cash flow from operations and free cash flow, excluding the settlements I mentioned, were a solid $5 billion and $3 billion, an increase of 9% and 8% respectively, compared to 2012.
During the fourth quarter, we did not repurchase any shares. During the entire 2013, we purchased 12.8 million shares for approximately $500 million as part of the $3 billion share repurchase plan that was authorized in December of 2011.
Together with dividends paid, we have returned approximately $1.6 billion in cash to our shareholders this year, representing 49% of our cash flow from operations after the payment of certain legal and tax settlements this year, or 69% of our free cash flow before dividends, but after the payment of those settlements.
I believe all of these measures, coupled with the dividend increase we announced, strongly demonstrate the ongoing commitment of Teva and its board to reward and return cash to our shareholders.
Looking ahead now to 2014, we are reiterating today the full year guidance we gave on December 10. We have started the year on the right foot, with the approval of Copaxone 40 mg and the appointment of Erez Vigodman as our new president and CEO, and are very excited about the prospects we see ahead of Teva this year.
We will of course continue to update you on the progress we make on all fronts throughout the year. This concludes my prepared remarks. Thank you all for your time and attention. I would now like to open the call for Q&A.
[Operator instructions.] Our first question comes from Ken Cacciatore of Cowen & Company.
Ken Cacciatore - Cowen & Company
Just wanted to clarify on the costs. It sounds like the $500 million definitively gets to the bottom line next year, and you’re going to have flexibility depending on other opportunities. But I was wondering, is some of the potential cost savings going to be predicated on your retention of Copaxone if there’s a generic launch? So I wanted to understand if there’s any flexibility around that.
And then also, just wanted to understand if you were thinking or contemplating about limiting the once-daily Copaxone for the three times daily, i.e. kind of forcing a conversion or trying to accelerate the conversion, how you think about that?
Regarding expenses, the minimum that we see flowing through the bottom line over the program is $500 million. It could be more. I believe that you face reality. A generic introduction of Copaxone will force us to sharpen our thoughts on corporate efficiency again, again, again. There’s no doubt about it. But right now I think we’re running pretty well with the cost reduction program.
2013 was not supposed to be a meaningful year. We’ve done a little better. We’ve reduced our headcount by about a thousand employees during the year by tightening the belt, and I will definitely not [unintelligible] anything which is unnecessary to build value.
First of all, we are delighted that we have the registration for the three times weekly 40. And within 24 hours after receiving that, we got the product to pharmacies in the U.S., and that’s also quite an accomplishment. We have done everything that we can to increase the nursing staff and get the message out to patients and doctors, but ultimately they decide whether they want to use the three times weekly 40 or continue to use our 20.
What we know from market research, though, is that it’s very encouraging. And we just confirm our previous guidance of anywhere between 30% to 50% of the patients will switch by the end of this year to the three times weekly 40. But we definitely have no plans to force a conversion. That’s not how we approach the business, or limit the 20 in any way at this moment.
Our next question comes from Liav Abraham with Citi.
Liav Abraham - Citi
First, on your U.S. generic business. You mentioned, I think, seven incremental first to file opportunities in 2013. It seems as though this number is a little low compared to some of your peers. You’ve stressed in the past that the strategy for your generics division is to focus on first to file opportunities. So can you comment on what you’re doing to maximize the strategy going forward?
And then just following on from a question on the structure of your R&D organization, I understand that you’ve globalized this organization with generics and branded R&D under the same umbrella. Can you comment on the merits of this strategy, and do you think that there’s sufficient focus on generics R&D within the organization given your increased focus on branded products, NTEs, and your branded portfolio generally?
If we think of the U.S. generics business, you’re right, we did launch 21 products this year, more than anyone else, and those 21 products, seven of those were first to file. To preempt, perhaps, the submission question, we submitted 21 products, and of the 21 products we anticipate about eight of them will be first to file. We won’t know until clearly we hear from the FDA.
And as we look to the future, we see that percentage ramping up to about 50% of our U.S. submissions we anticipate being in the first to file category. So we’re very optimistic about our business, and the submissions and the launches that will come from that.
We do know there’s been some recent data published by some of our competitors that are suggesting they have stronger first to file positions. A couple of comments on that. First, the data that was presented that we saw combined internal company data of that company with publicly available company data of their competitors, including ourselves. And therefore, in the Teva numbers that were presented, severely undercalculated the number of first to file products that we anticipate getting within our portfolio as we look to both historically and to the future.
And then finally, to reinforce the value focus, we’ve looked through the information that was disclosed in the [Actavis] presentation, 11 products that were disclosed, let’s say that two thirds to three quarters of them represent a very small portion of the value creation that they articulated. 20% to 25% of the products are where the major value creation comes from.
We were in a race with Actavis on those products. I think we do have to admit that Actavis beat us on two of those, but that doesn’t mean that we won’t continue to win on others, and our focus is to, again, look at those high value first to file complex generics, devote over 50% of our R&D investment towards those products, and leverage those for value creation.
And with that, I’ll turn it over to Michael to describe how well we’re doing in that area.
Just with regard to the emphasis on generics, I would say we continue to have a sharp focus with regard to our generics R&D portfolio. The major focus over the last few years and survey enhanced in 2014, will be to build up our complex technology portfolio. And we are investing significantly in that particular area to look to having our complex generic products becoming a very significant part of our submission in the near future.
The integration between the generic and the specialty organization has been remarkably successful, tremendous synergies, unexpected and expected. Of course, the major bonus has been the integration with the development of the NTEs, and as you know, we had 14 NTEs last year. And looking forward to another 10 this year. Of the NTEs, we will have our first NTE filed this year, and eight of them coming to submission in the next three years.
And this reflects a combined integration between the skills both in the generic business and the branded business. And then just for example, in terms of our integration, the good example is the integration of our devices portfolio and our devices technology, where of course this is serving both our generics and specialty business and this has proven to be tremendously strengthened, synergized, and of great use to both research efforts.
Our next question comes from David Maris from BMO Capital Markets.
David Maris - BMO Capital Markets
First, some investors are concerned that when a new CEO joins, they often reset guidance. But is it fair to say that since the company is reiterating its guidance now, and the new CEO is already on the board, that that’s something that’s unlikely or not going to happen when he officially takes the role of CEO?
Separately, on the three times a week availability, there seems to be a little bit of confusion. Is that widely available as of right now in the U.S., or will it be in the next few weeks?
We reiterated our guidance. That’s the best information that we have available, and we analyze it on an ongoing basis. The habit of new CEOs to reset hopefully is not going to repeat in this case. And other than that, Erez of course will be leading this call next quarter and I hope many will have a chance to meet him before that.
Like I said, we launched the Copaxone three times weekly. Within 24 hours, in the U.S., it came into the first pharmacies. But it’s widely available now, so very pleased to take away that confusion. It’s a fantastic product that many patients can now benefit from everywhere in the U.S.
David Maris - BMO Capital Markets
And then just as a follow up, when we got together in Israel last week, we talked a little bit about the likelihood of one generic versus two generics versus no generics. Is it still Teva’s belief that there are very critical and credible reasons that generics shouldn’t be approved for Copaxone? And then if you could maybe just remind investors what those might be?
I will forward this one to the scientists in the room. Michael, can you please refer to David’s question?
I think Teva’s position has been, and as you well know there’s been new data that we have published just in January, that demonstrated significant differences in the biological and immunological effects of Copaxone and various reported generics.
And while we recognize even in our own assessments that Copaxone by certain measures can look similar to the purported generics, in others that potentially have more clinical significant, which is pathway activation and mechanisms of action, we’re seeing significant differences.
Now, we would never predict what the regulatory authorities and how they would interpret this, but I think from our own point of view we see significantly different impact on genes associated, by the way, with key immune response mechanisms that would further underlie the need to really understand the clinical and biological effects of purported generics relative to Copaxone. So we believe there’s an important case in terms of patient safety and clinical efficacy to be made about the importance of clinical trials in this respect.
Our next question comes from Randall Stanicky from RBC Capital Markets.
Randall Stanicky - RBC Capital Markets
Eyal, in light of the business development goals, it sounds like you’re open to any idea. How is that different from the last five years? And could you maybe articulate how you’re thinking about return on invested capital differently or strategically, where you’re looking to grow the type of platform?
And then I didn’t hear you talk about divestitures, and there’s clearly a lot of businesses that you’re in that perhaps [unintelligible] the profitability level that you’d like it to be and perhaps couldn’t be going forward. Is that something that you’re looking at? Could we see broader divestitures over the next 12 months or so?
First of all, on business development opportunities, we’re open for business, but maybe in the past couple of years we have limited ourselves to small transactions, mostly focusing on building the pipeline and our portfolio. I think we’re expanding our thoughts, horizons, and views on looking at some other ideas which are out there in a very dynamic marketplace.
So as I mentioned in my prepared remarks, we will be looking at any idea that will create genuine value over time to the company and to its shareholders. And I think that everything else I can say about this would be unnecessary at this point.
Regarding divestitures, yes, we are looking to divest some of the noncore parts of our business. It’s not the core specialty, it’s not core generic, but the company has some additional activities such as distributions and activities that don’t really create or contribute a lot to our value. A number of investments [unintelligible] financial and in companies that have been accumulated of the years, all this is money that we’re going to generate and put it to work through our core programs.
So again, these things will have to be seen probably over 2014. We’ll move into some of those transactions. But we’re not talking about divesting very large and central pieces of the company, if that’s what you meant.
Randall Stanicky - RBC Capital Markets
Is it fair to say that the company has no bias, then, towards brand versus generic and we could still see sizable generic additions to the business going forward?
I would prefer to leave this question unanswered at this point, if you don’t mind.
We have Corey Davis from National Alliance.
Corey Davis - National Alliance
With everything that’s gone on at Teva over the past couple of years, and perhaps a change in focus in your generics business, could you explain whether or not there’s now a difference in your approach, if any, to how you think about and handle at-risk launches? I’m particularly interested in generic Oxycontin given your recent big court win and all those patents. You’re one of the few filers that hasn’t yet settled, and we’re still waiting for FDA guidance on [tamper] equivalents, so is this something that conceivably could contribute to 2014 revenue if all the stars align? Or is that probably too much of a stretch?
Let me start with the specific Oxycontin question. Clearly we’re very pleased with the outcome of the litigation. There’s still a number of legal and regulatory hurdles to get over to be able to commercialize that and bring that to market. We are aggressively pursuing those, and we hope we can convert those into first mover advantage and economic benefit.
But I would say that there are hurdles ahead of us, including the fact that no generic has yet received regulatory approval on this product, but we are working with the FDA to do that. With reference to your question of at-risk launches and someone who’s been here for 14 years in the generics business, I can tell you that as we look at our paragraph 4 first to file strategy, we are aggressively looking at all opportunities where we can be first, create value, create sustainable value.
I would remind us, however, relative to where the patent cliff has been, those opportunities in size and scale are not as great as they have historically been. But that said, they do create good economic value for us, and we continue to focus upon them as part of our strategy. I would just remind you that in December 2012, when we talked about the generic strategy, we said that more than 50% of all of our submissions have a first to file challenge associated with them, paragraph 4 first to file challenge associated with them, and that is our strategy going forward, and will continue to be our strategy.
Corey Davis - National Alliance
And then just quickly back to the FDA, you said that you’re working with them. How would you characterize the nature of those interactions? Do you think they’re close to coming up with [tamper] equivalence guidance? Or is it premature to say that they are close?
I think it’s premature to give timelines on what the FDA will or will not do, but I will reiterate, we are in close dialogue with them.
Our next question comes from Jami Rubin from Goldman Sachs.
Jami Rubin - Goldman Sachs
I’m just trying to understand the numbers this year. Copaxone beat, by $500 million relative to your initial guidance, which by my math is a 76% operating margin that you disclosed for that product should have produced a $0.40 beat over the midpoint of your guidance. So clearly there were significant offsets, and my best guess is that those offsets came from weaker generic sales and weaker operating margins, or weaker profitability in the generic business. Is that a correct characterization? What else in the base business created that shortfall to the very strong Copaxone beat?
And how do we think about the profitability of the generic business going forward? I think you gave guidance for 2014 of 41% to 44% generic gross margin. How should we think about that going forward? And if you could explain, again relative to your initial guidance, why the numbers came in so much below your expectations?
There were some events in the business that offset the fantastic performance that we had with Copaxone. It wasn’t just Copaxone. It was also other parts of our specialty business. And as we have reported, first and foremost, about $130 million of operating profit were robbed, so to speak, by exchange rate, with some of the currency weakening against the dollar, and some strengthening against the dollar, like the Israeli shekel, which hit into our operating profitability.
That’s one piece. We had a particularly weak year in our third-party API business. Part of that had to do with managerial issues, part of it had to do with safety issues. We have checked our entire network. I believe that in 2014 we’re going to see much improvement in that area.
Our weakness in generic business in Japan. Again, part of that was strongly influenced by the weak Japanese yen. To remind everyone, it was around 81 yen to the dollar at the end of last year and it’s 105 or over 100 right now. That’s something like 25% taken off our profit right there.
So there were parts of the business that went the other direction. In operations, we had an excellent year. We improved our service level dramatically, but at the same time we cleaned out the house. And that also resulted, and we have reported that throughout the year, in writing off excess inventory in all our markets, in order to come cleaner into 2014, and at this number [unintelligible], even [unintelligible] fourth quarter at about close to $190 million. These numbers are not going to repeat next year. So the combination of all that offsets our performance of the specialty business.
As to your question on the profitability of our generics, you see that the profitability of the generic business in Q4 is in line with what we have guided for 2014, and we believe that we’re going to deliver that at least. A lot of our cost reduction programs are going to hit the bottom line of the generic business as we said. It’s not a one-sided picture. We are going to improve and get a lot of money into the bottom line of our generic business in order to improve competitiveness and redeploy some of the savings into the specialty business by building our future.
But we believe that the generic business of Teva is stable, is well managed, is going to grow in emerging markets. We had a pretty good even excellent second half in the United States business. We improved the profitability in the European by exiting some of the low profit activities like tenders in many of the countries which are common today. And I believe we will see profitability improve in that area next year.
We have Elliot Wilbur on the line from Needham & Company.
Elliot Wilbur - Needham & Company
If I could just follow up on Jami’s question specifically, for Allan first, I guess, initially. In looking at the segment profitability measures on the overall generic business, I guess my impression had always been that the European business was generating segment profitability or op income profitability somewhere in the low to mid-teens, and obviously the U.S. would be much higher. But that doesn’t seem to be the case. Maybe you could just speak about the relative profitability of U.S. generics versus Europe and the rest of the world.
And I wanted to follow up with more of a big picture question, and I guess I’d direct this to you as well, Allan. One of your larger international competitors is talking a lot about intensified consolidation of the distribution channel in the U.S. and now even more consolidation in the distribution system worldwide.
And the suggestion there is that’s just going to put a lot of pressure at the margin on some smaller players, and also potentially result in another leg down in overall pricing. But obviously, if you look at the data and especially in the U.S., certainly the numbers don’t confirm that, because the pricing environment itself is relatively healthy.
So I guess just what are your thoughts on that subject matter, and how do you see that playing out over the next 12 to 18 months here? And do you think the risk is really more relevant for smaller companies that don’t have large portfolios? Or do you think there’s a growing risk of maybe a far less favorable pricing environment going forward than investors seem to be expecting?
I’ll take the first question, on the overall comparison of our generic businesses around the world, and Allan can definitely talk for the consolidation in the industry and what is happening in his field.
But you know, just on the scale that we’re seeing, our U.S. generic business is definitely the most profitable part with gross margin of about 50%. It’s a little over 40% in Europe, it’s around 35% but improving next year in Japan. It’s close to 50% in emerging markets, and it’s around 33% in our API business, which when you look at our overall generic business compared to last year, that’s where we were hurt the most, but we believe we know how to fix it.
We also, in the comparison of the last year, did not have the Ranbaxy royalties on the [unintelligible] launch, which was sales and EBIT were exactly the same number, because there was [unintelligible], no sales expense, and that is missing for the numbers in the comparison.
Overall, we believe that our European business is stable. The U.S. generic business is highly profitable and in Japan in API, 2015 will be years where we are going to improve profitability.
Maybe just building on what Eyal said, we are reporting a 14% top line growth on the U.S. generics business in the fourth quarter. In the back half of the year, when we have an apples to apples comparison of six months versus six months, we reached double-digit growth and at the gross profit levels that Eyal was talking about, it is a very valuable business to Teva. And we see it continuing to be on a go-forward basis.
With regard to consolidation of the distribution base, definitely. I mean, you know as well as I do that three major transactions or combinations have been announced in the last 12 months. And we remain extremely optimistic about that consolidation.
We are finding, as we said in previous calls, that as our distributors globalize and increase their complexity and get bigger, they’re looking to the large, global players to be able to work with, to help them to find the synergies that they’re looking for. We operate in 60 countries in the world, we have one of the biggest global footprints, and we’re well-positioned to capitalize on that globalization.
We’re already about 18 months into the Walgreens Alliance Boots combination with AmerisourceBergen coming on stream, and we’re working very closely with them in creating mutual value that helps them to achieve the synergy targets that they’re looking for, but also creates value for us and enhances the value creation in our business.
So overall, I would concur with the trend that you’re hearing. I do believe that the large, global generic players will benefit from this globalization. I do agree, we will see some margin squeeze, that we’ll look for lower or enhanced margins, but managing mix and pricing together, we can find a way to offset that and continue to grow our business, as we’ve seen in the last six months and in the last 12 months, if you exclude the atorvastatin royalty situation.
Our next question comes from Gregg Gilbert with Bank of America Merrill Lynch.
Gregg Gilbert - Bank of America Merrill Lynch
Michael, can I get your personal prediction as to whether generic Copaxone will happen on time? I know that the company is planning financially for generics, but I would like to put you on the spot on your personal view on that.
With regard to personal predictions, I’m a scientist. I really don’t make predictions about the extent. But what I am going to say is that there is compelling data that raises significant doubt about the clinical and biological effectiveness and similarity and sameness of purported generics and so we believe that the onus should really be on demonstration of efficacy and safety.
Of course, Teva is a generic company, we understand what it is to show bioequivalence and sameness, and we believe the same standards should be held here.
Gregg Gilbert - Bank of America Merrill Lynch
And Rob, on the 40 mg, your 30% to 50% switch goal for the 40, I know that’s based on market research that was done in the past, but now that you actually have the approval and are shipping product, do you have any tangible metrics you can give us in terms of the percentage of existing Copaxone patients that have called or visited their doctors or specifically intend to make the move to help support your 30% to 50% prediction?
And then secondly, if the 20 mg does go generic in a few months, is it fair to assume that you would bridge any pricing gap that exists for the patient on 40, so that a 40 patient doesn’t have an incentive to go back to 20 from a cost standpoint?
[We’ve fixed our] guidance based on the most recent market research we have, and all of the interactions, feedback, initially, is exactly what we expected. So we continue to just give the same guidance being optimistic about achieving those 30% to 50%. And as you can expect, we’re really very, very closely monitoring all of this to be able to react to whatever need is there.
And as to pricing strategy going forward, obviously I’m not going to comment on that. It’s too much of a commercial strategy that I really don’t feel comfortable disclosing at this point in time.
Our next question comes from Ronny Gal from Sanford Bernstein.
Ronny Gal - Sanford Bernstein
First, regarding the capex, you’re running over a billion dollars of capex and I just remember the presentation from your friends from [unintelligible] suggesting 250 for the year. You did more than that in the quarter. Can you just give us a feel for the capex trend going forward? Should we begin to see a decline in that number, and what’s the goal for like three years out?
Second, Treanda, we’re beginning to see softness in the prescription. Can you describe a little bit of the competitive dynamics with Treanda?
And third, obviously there’s a lot of stuff going on in respiratory. Can you just review for us where you are in terms of major pipeline products and launches? I think you mentioned a Symbicort lookalike. And if you can also describe where you are with your Advair program?
Our capex projecting for the year is close to $1 billion. The comparisons that we were making, we need more details in order to understand it. I’ll tell you where we’re investing. First of all, we are doing an overhaul to our IT system, moving the entire company to SAP. One system for the entire company [unintelligible], a combination of many, many companies with different systems. That costs money.
We’re building a new plant for the OTC products in India, a brand new plant, and a new plant in Russia, which we announced about a year ago. These investments are ongoing. We’re investing in new technologies, biologic capabilities. We’re investing in API. Anybody that has an API business knows that that has a lot of capital investment.
So yes, our capex budget is about $1 billion. We’re looking at it in order to do the most efficient possible thing. We’re also moving production from high cost locations to low cost locations and expanding in eastern Europe and in India, all [unintelligible]. These are the numbers, and these are the major items of our investment.
Treanda, it’s how you define weak. We’re growing 17% year over year, outperforming the market in every single respect. I wouldn’t call that weak. And the fantastic news on Treanda, actually, that we’ve had a confirmation of orphan drug status, which will give the indication, one of the indications protected life, until February of 2016. So Treanda is doing really well. Current performance is good, and we enjoy longer protection than we believed a year ago. So I actually believe that’s good news.
With regard to the respiratory pipeline, of course this is the year we would expect results on our reslizumab study in midyear. So this is going to be an important year for that particular franchise. But with regard to our whole R&D strategy, in terms of respiratory, it’s broad-based. As you probably recall, we have 10 clinical stage programs. We’re targeting all the major drug classes, and we’re entering a new [unintelligible] of [high drug] classes in asthma and also looking at adjacent disease areas like [RAC], coming out of our MicroDose acquisition.
We are also, with the MicroDose acquisition, looking at next generation devices that are really going to be focused also on the elderly and the young. We do have an [AB rated] strategy in the U.S., and this is underway. Also, by the way, it reflects tremendous integration, a good example of the integration between our branded and our generic businesses that has come together very quickly as a result the integrated organization.
We’re expecting about 13 submissions in the next five years, and we’re expecting strong growth from our current franchise, which is around $1 billion. So this is a very strong, burgeoning portfolio with tremendous upside.
We have David Amsellem from Piper Jaffray on.
David Amsellem - Piper Jaffray
Can you talk about the rate at which you’re losing Copaxone patients to the orals in the fourth quarter and into Q1? And do you see that potentially accelerating over time as neurologists gain more comfort with the orals that are available?
So far, actually what we have seen is fairly minimal impact of competition. Copaxone is and remains the gold standard, and I think this is related to the fact that patients and doctors alike trust its proven efficacy and safety, its entire clinical profile, and all of the experience.
So actually, for five months in a row, Copaxone is now the leader in new prescriptions, and it was always the leader in total prescriptions. So there has been, obviously, some sort of market share taken by the orals. In all, it’s a very low digit single digit loss that we’ve had, and Copaxone is holding much, much better than I think many people expected 12 months ago.
And frankly, going forward into 2014, we’re expecting Copaxone to hold its ground. Obviously the orals will continue to gain some market share, but at the moment we see it go more at cost of some of the interferons, and really at the cost of Copaxone.
I will now turn the call back to Eyal Desheh for any closing comments.
Thank you very much, operator. I’d like to thank you all for listening, and I’d like to thank you especially for bearing with us. It was a little bit of a bumpy call on the communications, but I believe it was a good call on the question and answer. So I appreciate your patience. Thank you for your questions. We’ll be taking calls from anybody that wants to contact us immediately after this conference call is over, so we’ll be happy to answer all the additional questions that you may still have. And we’ll talk to you during the quarter and on our next earnings call. Thank you very much and have a wonderful day.
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