John Elicker - VP of IR
Jim Cornelius - Chairman and CEO
Jean-Marc Huet - EVP and CFO
Lamberto Andreotti - President and COO
Elliott Sigal - CSO
John Boris - Citi
Tony Butler - Barclays Capital
Jami Rubin - Goldman Sachs
David Risinger - Morgan Stanley
Steve Scala - Cowen
Seamus Fernandez - Leerink Swann
Keyur Parekh - UBS.
Chris Schott - JPMorgan
Tim Anderson - Sanford Bernstein
Bristol-Myers Squibb Co.(BMY) Q3 2009 Earnings Call October 22, 2009 10:30 AM ET
Good day, and welcome to today's Bristol-Myers Squibb third quarter 2009 earnings release teleconference. Today's call is being recorded. At this time, I would like to turn the call to Mr. John Elicker, Vice President Investor Relations. Please go ahead Mr. Elicker.
Thanks, Tony, and good morning everybody. Thank you for joining us to review our Q3 results. With me this morning are Jim Cornelius, our Chairman and Chief Executive Officer; Jean-Marc Huet, our Executive Vice President and Chief Financial Officer. Both Jim and Jean-Marc will have prepared remarks. Also joining us are Lamberto Andreotti, President and Elliott Sigal, Chief Scientific Officer will be available for Q&A.
So, before we get started, let me cover the legal requirement. During this call, we'll make statements about the company's future plans and prospects, including statements about our financial position, business strategy, research pipeline, concerning product development and product potential. These constitute forward-looking statements for purposes of the Safe Harbor provisions under the private securities litigation Reform Act of 1995.
Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors including those discussed in the company's most recent annual report on Form 10-K, periodic reports on 10-Q and current reports on form 8-K. These documents are available from the SEC, the Bristol-Myers Squibb website or from Bristol-Myers Squibb Investor Relations.
In addition any forward-looking statements represent our estimates only as of today and should not be relied upon as representing our estimates as of any subsequent date. While we may elect to update forward-looking statements at some point in the future, we specifically disclaim any obligation to do so even if our estimates change.
Thanks, John, and good morning, everyone. Our third quarter clearly shows how we are transforming Bristol-Myers Squibb into a BioPharma leader. As you know, we unveiled the BioPharma vision for the first time in December of 2007. Since then, we have consistently delivered outstanding financial performance through a combination of marketplace execution and productivity initiative. We are mainly focused on biopharmaceuticals and we're building our Mead Johnson Nutrition Global business as well as a separate 83% owned affiliate.
Finally, we are discovering, developing and delivering innovative new medicines led by the efforts of our R&D and commercial organizations. On the top end bottom-line, we are driving solid financial performance. Our BioPharma revenues grew 6% globally led by an impressive 12% sales growth in the U.S. business.
Our brands face new and expanded competition and we are successfully meeting the marketplace challenges. For example, PLAVIX grew 9% globally, ex-Foreign exchange, despite the launch of Lilly's Efient. BARACLUDE was up 37% ex-FX and ORENCIA up 38% on the same basis in very competitive markets in both Hepatitis B and rheumatoid arthritis, respectively. REYATAZ had a 9% growth worldwide ex-Forex and remains the protease inhibitor of choice even with increasing competition.
While growing revenue, we also focused on gaining cost efficiencies through continuous improvement. You can see the results of these efforts in our BioPharma gross margin improvement of a 170 basis points. At the bottomline is our non-GAAP earnings per share from continuing operations grew 16% versus last year.
Reflecting the strength of our business performance, we are refining our 2009 non-GAAP earnings per share from continuing operations guidance to the range of $2 to $2.05, which is at the high-end of our previous guidance.
Our net cash position at September 30th was $1.3 billion and that's after taking into account the $2.1 billion net impact of our important Medarex acquisition, the latest in the String of Pearls. Also today, Mead Johnson announced it's considering options to refinance its intercompany debt, which could result in $1.75 billion payment to us, upon closing of that refinancing.
Our financial strength and strong cash flows provide us the flexibility to execute the String of Pearls strategy, and we will continue to aggressively pursue acquisitions, licensing deals and other partnerships. With our decisions over the past few years, we've increased the focus on our BioPharma business, that is bringing innovative medicines to patients.
Our latest launch is ONGLYZA for the treatment of Type 2 Diabetes. Diabetes is an emerging global epidemic. We've collaborated quite well with our colleagues at AstraZeneca on ONGLYZA and we are optimistic about its potential. We have launched in the U.S., Mexico, United Kingdom and Germany and are moving quickly to launch in additional markets worldwide.
We've also recently announced the FDA's acceptance of our biologics licensing investigation for belatacept. The investigational compound designed to help prevent rejection of transplanted kidneys. In addition, we presented the first Phase III data for dapagliflozin, a novel medicine for the treatment of Type 2 Diabetes.
Research and development at Bristol-Myers continues to be very productive and is preparing our company for leadership in a number of areas of unmet medical need. Through consistently strong operational results, disciplined financial management, advancement of a robust pipeline and continued focus on strategic execution, we are making excellent progress, as I said earlier in our transformation to our next generation BioPharma leader.
Now to give additional color on our third quarter performance, our Chief Financial Officer, Jean-Marc Huet.
Thank you very much, Jim. I will review our Q3 results and our 2009 guidance before we go to your questions. In summary, our third quarter performance was strong. GAAP EPS increased 66% versus the same period last year and our non-GAAP EPS was up 16% versus Q3, 2008. Solid operational performance reflected in sales growth in our BioPharma business along with continued focus on expense management resulted in yet another strong quarter for Bristol-Myers.
Let me turn to revenues. The company posted Q3, 2009 net sales from continuing operations of around $5.5 billion, which represents an increase of 4% or 7%, excluding foreign exchange impact compared to last year. Mead Johnson's net sales were just shy of $700 million in Q3, representing a 6% decrease or a 2% decrease ex-FX compared to prior year.
Now let me just focus specifically on our BioPharma business. Our BioPharma sales were up 6% in Q3 or 9% ex-FX. Our U.S. sales grew 12% to $3 billion compared to last year and internationally our net sales decreased 2%, but increased an important 5% when you exclude the impact of foreign exchange.
Foreign exchange negatively impacted our BioPharma Q3 net sales by approximately three percentage points. We had a positive 5% impact from price, and again and importantly a positive 4% increase in volume. So in summary when it comes to topline, our underlying business is strong and we've had consistent sales growth this year.
Let me walk you through some of the highlights. Firstly, turning to cardiovascular. On a global basis, PLAVIX sales were up 9%, excluding foreign exchange. In the U.S., our Q3 net sales for PLAVIX were up 11% versus last year. The increase is driven by price increases but again, also importantly volume gains. To date, [Efient] had minimal impact on PLAVIX sales.
Turning to Europe, generic clopidogrel is commercialized in six EU markets; Germany, U.K., Denmark, Netherlands, Belgium and France. We do anticipate generic launches in Italy, Greece, Portugal, Norway and Sweden between now and mid next year.
Turning to neuroscience, in the quarter ABILIFY worldwide sales ex-FX were up 18% versus prior year. About two-thirds of our sales growth in the U.S. comes from indications for bipolar and major depressive disorder. Our strong clinical program for ABILIFY has led to the broadest set of indications for any atypical.
As part of the extension agreement we signed earlier in the year with Otsuka, reported alliance revenue is lower by $16 million in this quarter and that reflects the amortization of the $400 million upfront payment that we made to Otsuka earlier this year.
Turning to our virology franchise. The virology portfolio had global sales growth of 12% excluding foreign exchange when you compare it to last year. This was led by BARACLUDE at plus 37%, the Sustiva franchise plus 11% and REYATAZ which posted sales growth of 9%. A very steady growth in the face of competition from the new protease inhibitors launched this year.
Nearly seven out of 10 new treatment patients are prescribed either Sustiva or REYATAZ as part of their initial antiretroviral regimen. BARACLUDE global sales were just shy of $200 million at $191 million in the quarter and BARACLUDE has market leadership in the EU, China and Japan.
Turning to immunology, ORENCIA sales were at $160 million, plus 38% ex-FX. In the U.S., ORENCIA grew with 30% driven by continued execution as well as favorable market conditions.
Important new data were presented just this week at the American College of Rheumatology meeting, the agreed study suggests ORENCIA can be used earlier in rheumatoid arthritis patients who are new to biologics. We also for the first time released Phase III data showing the potential for subcutaneous administration of ORENCIA.
Turning to oncology, ERBITUX sales in the U.S. were at $175 million, down 4% versus prior year, but up 2% since Q2. ERBITUX sales in colorectal cancer have begun to stabilize, despite a decline in the overall colorectal cancer marketplace. Total head and neck market growth has been flat versus prior year, as well as prior quarter.
Turning to SPRYCEL, global sales were at $107 million, up nearly 40% versus prior year if you exclude foreign exchange.
Turning to Metabolics, ONGLYZA was approved in the U.S. in July as you know and in Europe in October. We, along with our good partners at AstraZeneca, have launched in the U.S. and also in Mexico, the U.K., and Germany and look to launch in a number of additional key markets in the near future.
We recorded $20 million of sales in the third quarter for ONGLYZA. We have made good progress in our launch to-date and positive signs include improved access and reimbursement globally, a rapid increase in brand awareness by physicians and positive trends in physicians' intent to prescribe the drug.
Let me go back now to the P&L and let me also specifically comment on our P&L focusing in on our BioPharma business. If you look at gross margins, we realized a 170 basis point increase in gross margins compared to the same period last year. The key drivers were multifold. One, prices; two, cost savings; three, favorable FX as well as product mix.
When you look at our pretax earnings for the BioPharma business, they were up 19% and the increase was driven by sales, gross margins as well as the reduction in marketing, selling and administrative expenses.
For the quarter, we reduced our BioPharma SG&A as a percentage of sales by 3.4% from 28.2% a year ago to just south of 25% in Q3, 2009. This figure has steadily decreased since the first quarter of 2008, when BioPharma SG&A as a percentage of sales was just under 30%.
Turning to R&D. BioPharma R&D expenses did increased by 5% to $820 million. However, as a percentage of sales, this was flat at 17.1% for the quarter, compared to 17.3% this time last year. This was accomplished even with adding expenses from three pearls versus the same period last year.
Turning to taxes, our overall company non-GAAP tax rate on earnings from continuing operations was at 24.4% for Q3, compared to 25.3% in 2008.
Let me now turn to cash in our balance sheet. We continue to drive and focus on cash flow, and our employees have fully embraced this philosophy. We currently have $7.9 billion of cash as per the end of September this year and that includes cash, cash equivalents as well as marketable securities. This supports the financial flexibility we need to invest in our existing business, as well as potential business development activities to improve the earnings profile of the company in our important Stage II as well as Stage III.
Even after the $2.1 billion net impact of the Medarex acquisition that we just completed, we still have a net cash position of $1.3 billion at the end of the quarter. Based on Mead Johnson's announcement today that it is considering options to refinance its outstanding into company debt, we expect to receive approximately $1.75 billion in U.S. cash upon closing of this potential transaction.
Also, in the quarter, we announced two strategic divestitures in Indonesia and in Australia for a combined $372 million in cash. This cash we expect to receive in the fourth quarter. We have excellent operating cash flows and continue to make progress on our working capital initiatives, which we announced to the outside world in Q3 of last year. This has helped drive our positive net cash position.
Our net trade receivables, inventories and accounts payables, as a percentage of net sales was at 11.2% in Q3 of this year. This compares to just under 13% at the beginning of the year, so good improvement through the last three quarters.
Let me now turn to guidance. We are updating our 2009 non-GAAP EPS from continuing operations guidance range from $1.95 to $2.05 to $2 to $2.05. We are raising our 2009 GAAP EPS guidance from $1.58 to $1.68 to the new range of $1.72 to $1.77.
We are pleased in summary with our operating performance to date and expect 2009 full year EPS to be near the high-end of the originally stated guidance. A couple of things just to keep in mind for the fourth quarter. There is the impact for the full quarter that takes place from the Medarex acquisition. Secondly, please take note of the fact that we will start to be impacted by the increased generic competition for PLAVIX in the EU and this will continue to erode in our equity and net income from affluences line in Q4 and further into 2010.
We do reaffirm our guidance that non-GAAP EPS from continuing operations is expected to grow at a minimum of 15% compound annually from 2007 until 2010, i.e., next year without rebasing for ConvaTec. We are maintaining this long-term guidance, not withstanding the dilution from the very important ABILIFY extension, the dilution from the Medarex acquisition, which as we disclosed would be between $0.07 to $0.09 next year as well as the generic competition for PLAVIX in Europe which I just mentioned.
In closing, as has been the case with our past several quarters, our third quarter performance was solid by any measure. Strong sales growth with improved gross and pretax margins resulted in a 16% increase in non-GAAP EPS from continuing operations. Across our organization, we are accelerating our transition into a next generation BioPharma leader.
Thank you very much and we're happy to take questions.
Thanks, Jean-Marc and thanks, Jim. Tony, I think we're ready to go ahead for questions if we could go ahead and start.
(Operator Instructions) We'll go first to John Boris at Citi.
John Boris - Citi
Jim, first question just has to do with 2013 and beyond and how you're thinking about the growth profile of the company. Operationally, the company is running very well. A lot of pipeline visibility is obviously picking up and then you obviously have a lot of cash to be able to deploy towards pearls. So relative to the growth profile in '13, which we'd anticipate you'll probably share some of that with us in December. How you're thinking about that?
Then also on the Pearl side, just the size of Pearls, I think you've outlined somewhat of a limit on the size of Pearls, but how you're thinking about maybe larger Pearls going forward versus smaller Pearls and being able to enhance that growth profile.
And just one question for Jean-Marc on working capital. Kudos on the improvement, but can you help us understand where you'd like to take inventories going forward and how much cash you might see that unleash going forward?
Well, John, let me start on a very complicated issue. First of all, we do think about what we call stage two quite a bit. So, not 100% of our efforts are devoted to this outstanding short-term performance but the ABILIFY contract extension, for example, where we changed the cliff into a platform for growth would be an example of how we're thinking about stabilizing stage two. You paid us a compliment by saying we're getting increased visibility on our pipeline. We feel very good about the clinical data that's been released this year. We will have more to say, probably on December 2nd about the longer term stage two and stage three.
On pearls, big or large, they need to be shiny. And what I mean by that is they need to fit, what our disease strategy teams tell us that they need. So, I am going to turn that to Elliott to add a little color on the String of Pearls.
Well, John, as we've said before, the primary focus of our String of Pearls strategy is to look at deals that are accretive in the 2012, 2013 time period and not detrimental to grow past 2013 as well as deals that build our late-stage pipeline in several key disease areas by 2012. Our priority focus is to migrate into cardiology adjacencies, as you've seen, build our Alzheimer's portfolio, expand immuno-science and increase the strength of our HIV franchise.
Our secondary focus is to expand Hematologic Malignancies and build solid tumor capabilities. I believe, we've been successful to date and we'll be reiterating the strategy December 2nd, and the focus is on building the platform in Stage II and increasing the slope of what we see as growth in Stage III.
And just in terms of working capital, a couple points. Firstly, we've really have built a culture which is focused on cash flow and that is a real prerequisite to drive cash flow into specifically working capital. And so, I think we are very well positioned for further improvements from where we are today.
The second one, it's very much the approach we have also around productivity, as we will try and improve on a continuous basis. So, rather than just give a new target, we will just continuously improve year upon year. I guess the third point as you mentioned inventories, but, I'd just like to expand the point. We have receivables, inventories, payables. We also actually are very much focused on CapEx, but those four drivers are cash flow, ones that we are all pushing with the same type of rigor.
We do also need to be careful on inventory levels, and while there's more that we can do within the organization, we also are very much focused on maintaining the appropriate service levels. So, we're doing this all in a rigorous and in a continuous manner, but I'm very happy with the fact that our culture has embraced the drive to cash flow.
We'll go next to Tony Butler of Barclays Capital.
Tony Butler - Barclays Capital
Jean-Marc, a question for you, and two for Elliott. There has been a launch of several generic compatible compounds in Europe. I'm curious if that actually has occurred at a time that was earlier than you expected or is this congruent with your expectations and more importantly, how should we think about that joint venture and equity income line?
For Elliott, when you think about Belatacept, you obviously were great in following the compound, but are you puzzled as to why the FDA would not give you an accelerated review and I am curious of comments you may have around that?
Then secondly, with AVERROES and ARISTOTLE to complete in theory next year, is there any change in the timing of when those might complete and/or the thoughts between you and your partner on how that clinical trial should it be changed with respect to endpoints?
Tony, this is Lamberto. I will start on clopidogrel in Europe and then Jean-Marc may add something. It is clear that we were expecting generic competition of this size in Europe later. And it is clear that we have taken all measures that are necessary as much as we can offset the consequences of this generic, multiple generic launch in Europe. The PLAVIX franchise in Europe between us and Sanofi was well above $2 billion last year. And as Marc was reminding all of us, most of our share of that franchise is booked in through the line of income from minority or whatever it's called. It's not we don't book the top line, okay? This will obviously become noticeable in Q4 and in 2010.
Now having said that, we have a positive unplanned event that will allow us to look at the future in the world of cardiovascular metabolics in different way and this is the earlier launch than ONGLYZA in Europe. For sure, in our initial plan ONGLYZA wasn't for a launch in September 2009. It was at least one year later than that. So, this is very important because not only we had the contribution of ONGLYZA to our P&L, but we have transitioned our cardiovascular structures from PLAVIX to ONGLYZA.
So in summary a positive news from ONGLYZA, offsetting in the longer term the consequences of these earlier than expected launch of PLAVIX.
Just to add on very briefly to Lamberto's comments, we do a whole variety of internal scenario planning and have taken that into account and its generic erosion, when speaking about our 15% guidance, which includes next year 2010. But this is again, like Lamberto said, a line item in the profit and loss statement that we will need to focus more upon in the next quarters and will decline.
This is Elliot, you asked a question with regard to Belatacept filing, as well as an update on apixaban, particularly in atrial fibrillation. We now have the FDA accepting our BLA for the filing and review, and our PDUFA date is May 1st and I'm pleased with that. The assignment of a standard review recognizes, in my view, the complexity of the Phase III data for Belatacept, one of the first agents in a long time to undergo review in this area, as well as the complexity of the BLA filing itself.
As the data has shown, there are clear advantages, and yes there are challenges associated with Belatacept. We're very comfortable with the standard review and I think it allows the FDA and sponsor enough time to fully assess appropriately the BLA. So I think this is a good sign in general for the drug and I don't interpret it any other way.
With regard to apixaban, certainly the European Society of Cardiology was very exciting in the area of anticoagulation and we now have even stronger belief that WARFARIN can be unseeded because of the negative aspects of warfarin and probably because there's more anticoagulation to achieve efficacy by new mechanisms.
So we are very excited about that and very comfortable with our program that's extensive for apixaban. You mentioned about any changes, certainly we are now more confident that we might be able to achieve superiority in certain subsets of patients, perhaps and that we always evaluate the clinical programs and interact with the FDA to make sure that we can extract as much value from the program which as you said, includes two important studies. One uses warfarin as a competitor, the other uses aspirin in those patients who can't tolerate or are considered ineligible for warfarin. So we will have these studies completely enrolled soon, and we look forward to this field unfolding.
Yes, we'll go next to Jami Rubin at Goldman Sachs.
Jami Rubin - Goldman Sachs
This is the question for you, Jim. I'm sure you've noticed how well Mead Johnson has done since the partial IPO, just curious to know how and when you plan to monetize your Mead Johnson stake. I believe that the last time you referenced this Mead Johnson was trading $30 and you said you need to wait about 18 months or so to make a decision about a split off or spin off. But given that the stocks now at $42 based on our math, those strategies would actually yield an accretive impact to your earnings. So I'm wondering if you could just talk about what the options are looking like now and how you're going to assess those options? Thanks.
Well, I read your report and it's very helpful in thinking through the many alternatives we have for Mead Johnson. I think we've all been pleasantly surprised at how quickly it's gone up to $42 from its initial IPO. You do the math, that's over $8 billion of value embedded in Bristol-Myers Squibb. We own 83% of it. I think we're very pleased they announced their results this morning and outlook for the fourth quarter next year, I think are okay. We'll continue to look at the strategic options much like we look at all of our strategic options.
So couldn't be more pleased with the stock price, with the performance of the management, the most senior management now in Chicago and this new Board of Directors with four independent directors, the separation has gone without a hitch. And we're in really good shape as we approach year-end.
As Jean-Marc pointed out, we're anticipating if they're successful in refinancing intercompany debt of a significant cash payment to us for their intercompany debt, which is $1.75 billion.
Next to David Risinger of Morgan Stanley.
David Risinger - Morgan Stanley
I just have a couple questions. First, Jean-Marc if you could just tell the FX impacts on EPS? And then second, maybe a couple of you could just address SPRYCEL. Obviously you've delivered strong year-over-year growth for SPRYCEL. Could you talk about the sales outlook for that product? And also your development program to expand the label, particularly relative to Tasigna's development plans?
The bottom-line impact of FX was a negative, approximately $0.03 or so. That's specific answer to your question, but maybe I can just also take the opportunity to just talk about our gross margin because obviously FX is a driver within gross margin, but I think what makes us happy with the gross margin increases that we've posted in Q3 is that they're coming from product mix, they're coming from pricing, they're coming from savings that are taking place through our manufacturing rationalization. They are also being helped by Mead Johnson's increased gross margin as well as foreign exchange. So it's a driver, but not there are many drivers to our gross margin improvements, but to give you a specific answer to your question, the impact on the bottom line is approximately $0.03.
So, speaking of price, while you've seen the results, growth of sales in the U.S. of 33% versus previous year and international sales up 30% net of tax versus previous year. So, this is a consistent quarter-after-quarter growth. We will not change our strategy. We are supporting SPRYCEL as the preferred treatment option in second line CML. Our job in the U.S. and EU is to instill urgency among prescribers, among physicians to identify and treat people that are resistant to GLEEVEC and switch back to SPRYCEL and we've been successful so far.
If I look at our performance versus the performance of Tasigna, and I focus on the U.S. for now. Well, in relative to SPRYCEL a fewer doctors have prescribed Tasigna. Approximately 50% of use of Tasigna is in the third line following SPRYCEL. So we have quite a different performance, quite a different profile for our products. That makes us confident that if we hit a first line indication for our product, we will be very competitive there too against Tasigna. Elliott, do you want to add something on clinical trial.
Yes, Lamberto. David, you asked about our life cycle programs, so we're intently focused on a couple different arms of developing SPRYCEL further. First of all it has, unlike GLEEVEC, the SARC activity. So we are well underway in exploiting the opportunities in solid tumors such as in prostate cancer, which is in Phase III, and breast cancer with the focus on estrogen receptor positive disease in Phase II.
The next significant potential event as you referred to, is unmasking early next year the data for our first-line study, head-to-head with GLEEVEC. In many ways, similar to the study that was announced in a press release, but not scientifically discussed yet, on Tasigna versus GLEEVEC. Those studies are similar with, I think, an important difference in the primary endpoint. And the primary endpoint in our first line study versus GLEEVEC is confirmed complete cytogenetic response. And we took extra time to work out with the regulatory authorities that this would be acceptable for submission in both the U.S. and in Europe.
In fact, the European guidance recommends against the type of primary endpoint I have seen our competitors use. So we need to see the full data of both studies, not just the primary endpoint conclusions, but the safety profile for reasons that Lamberto mentioned is different in both drugs and perhaps more favorable with SPRYCEL. In that Tasigna has a black box for cardiovascular potential complications.
So this is a very exciting area. The positive results that are mentioned so far give me more confidence that we could be looking at a positive study, relatively soon, a well-designed study with interaction with regulatory authorities.
Next from Steve Scala at Cowen.
Steve Scala - Cowen
I have three brief questions. First, what dollar and unit share do a PLAVIX generic have in the EU? And then two for Dr. Sigal, first, on OASIS 7, do you plan to file the data, and if so what would be the objective with respect to labeling? And then lastly on apixaban is the ADVANCE-3 data in-house and if so, what are your filing plans in the U.S. and EU for DBT?
I will start with the PLAVIX EU. The latest data I've seen, were indicating that by the end of September, clopidogrel besylate, the generic clopidogrel in Germany at approximately 45% on market share in units. And we have seen -- but in other countries generic competition is now pricing their product at 40% of where PLAVIX is. I think this is the French price that has been recently established.
So, Steve, with regard to OASIS, are also called the current trial on PLAVIX, where we did the high-loading dose or as it's also been called the double dose clopidogrel study, which have some very -- I think important medical information that confirms medical practice and decreases any contrast with an alternative agent, prasugrel on efficacy by this higher-loading dose. I think this is important information for physicians.
Since this was independently run trial on the outside, we are still in the process of the usual procedures of going through the database, going through the data. We do plan as an alliance to talk to the FDA. The goal for the labeling would be to put to 600 milligram loading dose and associated data, which I think is significant with regard to the practice of medicine in the choices that people should have with PLAVIX.
With regard to apixaban, ADVANCE-3 will be the third orthopedic setting that we have tested apixaban to prevent clots in the legs. We do not have those results. I have not seen those results yet, but they will be relatively soon. As you know we hope to have a Late-Breaker at the American Society of Hematology on these results and when we look at the results of all three studies, we will make a decision with regard to A, filing in Europe and B, whether we consider filing in the U.S. But I don't have any more news at this time.
Next is Seamus Fernandez at Leerink Swann.
Seamus Fernandez - Leerink Swann
Couple of things. Can you update us on ORENCIA and the timing of when you expect to file and have final data for the subcutaneous formulation of ORENCIA and whether or not that dosing is once weekly or every other week dosing? Separately in terms of launch expectations, particularly for Belatacept, as it perhaps comes to market next year, how would you characterize your expectations for the launch, given the conservatism of transplant positions in that space?
Seamus, with regard to ORENCIA SubQ, we were excited to present the safety data part of the program from the subcutaneous formulation at pivotal trial recently at the American College of Rheumatology. These data do show that weekly SubQ abatacept results in low immunogenicity after repeat dosing and is well tolerated. So, that's step one.
Step two is the efficacy data. We'll get that early next year. We've done a very comprehensive trial so that we can extend the information we have on SubQ to make it relevant to everyone of the indications we have for the intravenous form.
Then there will be a period of time of analysis that's needed to make sure that the pharmacokinetics is all in order for us to give make that extension. So we don't have an exact filing date right now. We'll probably be in the second half of the year and we'll be able to update people later as that progresses. It should be filed for SubQ once weekly.
As far as Belatacept is concerned or the way we see it is, well we are aware that the key unmet medical need in the transplant world is the long-term outcomes of both the graft and the patient. So our commercial strategy for Belatacept it is to replace CNIs as part of the chronic multidrug immunosuppressive regimen that is standard of care following transplant.
We are very realistic. Our initial target indication is for use in new kidney transplantations and we're realistically thinking that it will take time to build out this product. On the other hand, we know that the data, the Phase III data that we have is encouraging and supports our target profile. So, we've included I believe Elliott, two-year data in our submission.
This would be presented in 2010.
And this support, I would believe, in the product, but again it will be not the fastest update you have ever seen because of the nature of the product and the nature of the market.
Thanks, Seamus. Can we go to the next question, Tony?
Next Keyur Parekh with UBS.
Keyur Parekh - UBS.
This is for Jean-Marc. When I say look at the kind of long-term guidance range between 2007 and 2010 and if I used the midpoint of the estimate EPS range for this year, it implies roughly a 3% EPS growth for 2010 and that's obviously kind of implies a fair degree of slowdowns relative to the last few years. I'm just a little bit confused about that. I mean is there material scope for upside on for 2010 minimum guidance range, as we stand today?
I don't think I can comment on this, but we will come back to you in terms of 2010 guidance when we normally do. I will just reiterate the fact that today despite dilution from Medarex, despite the impact of generics in Europe and despite the extension of ABILIFY. We reiterate a minimum of 15% earnings guidance from 2007 to 2010.
Thanks, Keyur. Tony, I think we just have time for a couple more questions.
We'll go next to Chris Schott at JPMorgan.
Chris Schott - JPMorgan
First question on dapagliflozin, can you just tell me the way of thinking on filing plans here. I believe your partner appointed to a second half 2010 timeline for U.S. filing with their last earnings call. Can you just tell me how you get to that type of date given the FDA's guidelines for new picked diabetes agents? And then second on the ONGLYZA launch, I'd be interested in where the U.S. formulary position currently stands and kind of when you'd expect to achieve your target access levels here?
Yes, well. We'll have more information on our exact filing plan as '010 unfolds. Our alliance partner, AstraZeneca and us are targeting and getting prepared for end of '010 submission. However, the cardiovascular safety, that original timeline was set before the cardiovascular safety requirements and we're in constant contact with the FDA and the types of trials that we have ongoing are all event-driven. So I can't give an exact date at this particular time.
With dapagliflozin, we are now just looking at our third Phase III study and this afternoon our second is being presented and the first was presented earlier. We have eight Phase III studies. So we have five more to go. I'm very encouraged by the target profile that's emerging, but we have four more Phase III studies in the completion of the assessment of no cardiovascular harm remained encouraged by this first in class opportunity in diabetes and we'll be able to update you when we know more about our filing plans.
Yeah and about ONGLYZA, it is clear that we have devoted a lot of efforts and attention to the inclusion in the managed care reimbursement lease and what we have achieved so far is good. This is last data indicate, we have ONGLYZA accessible to 75% of the overall [cover lags]. And of these cover lags, we have access to ONGLYZA 82% have accessed without restrictions.
In 28% Tier 2 and obviously our focus is to increase now the numbers in Tier 2. Speaking of ONGLYZA, I think that's a good opportunity for me to say that we are pleased from what we've seen so far. We are executing against our plan. We launched in August. We launched in the U.S. so many years ago. So we could work less on prelaunch awareness and therefore, we are very pleased to see that now that we're in the marketplace, awareness is going up from almost zero at the beginning to a good percentage now. The number of trials, the number of doctors that they're using ONGLYZA is increasing. I saw some data on intend to prescribe, which is also going in the right direction and access as I was describing before, is going the right direction too.
We and AstraZeneca are confident that we will deliver success here. We are waiting for the approval by DDMAC, the FDA's DDMAC of our promotional material. So far we can only promote in more or less the press release and the product profile. As you can imagine, I and many of my colleagues are spending a lot of time reviewing the performance of this product. We just launched in the U.K., Germany and some smaller European markets. As you can imagine, also, there we are very focused on the execution of our plan and looking forward to results.
Tony, I think we have time for two more questions.
We'll go next to Tim Anderson at Sanford Bernstein.
Tim Anderson - Sanford Bernstein
A couple questions. Going back to Mead Johnson, if you were to sell that either now or say the stock goes up to $50 or something you sell it, does that then change how you approach the String of Pearls because you already seem to have quite a bit of cash, that would obviously give you another big bars of cash and I'm wondering what the intent would be with that cash.
Second question is on ORENCIA; the product has been doing well and steadily growing. I'm wondering if you can talk about what you see as the competitive threat from Roche's ACTEMRA because that product seems like it's going to go straight for the market, where you sell most of ORENCIA, which is in that infusion phase after [Athena] failure.
Let me start with revisiting the Mead Johnson question. It's not out of consideration that we keep Mead Johnson because it's growing at a very nice rate, an important contributor to both sales and earnings. As we gain more confidence in what we described earlier as Stage II, they may not be as important at that point in time as they are today.
A sale, because of the very low tax basis results in a huge tax liability. So that's one option. A tax free spin-off is another and a tax free split-off is another. So, the consideration and timing of those four alternatives is very much what we're focused on, Tim.
Speaking of ORENCIA and ACTEMRA, obviously we are fully retention what will happen in the market at launch of ACTEMRA. It is true that ACTEMRA goes in to the same portion of the market, where we compete the IV portion, and we have a confident of what we have in terms of data, in terms of plan.
We have a product that has good efficacy and has a good durability of efficacy. So that the two things combine to make us believe that ORENCIA can compete and can compete very well and this is a safe product, ORENCIA, so we have a lot of winning points. And if you look at our performance versus REMICADE, that performance has improved quarter by quarter and we think that we can continue to deliver despite the launch of ACTEMRA. You know that we have the radiographic data out to five years, I believe which highlights that ORENCIA inhibits the structural damage and this is very important to give us confidence in ORENCIA as a long-lasting duration product.
Maybe just one comment on our cash position, Tim, as it stands today, we have a very strong cash position and that will increase, especially once there is recognition for this intercompany debt coming from Mead Johnson. As I also mentioned we have nearly $400 million coming through from divestitures that have taken place in the quarter. So we can really look at Mead Johnson from the perspective of doing the right thing for shareholders. Our cash position is in a very, very good place to just continue the String of Pearls as we've been mentioning each and every quarter.
Tony, can we go to the last question please.
We'll take our next question from [Eric Lo] with Bank of America-Merrill Lynch.
Just a couple quick ones; beyond the ABILIFY sales force announcements last week, are there plans to re-evaluate the sales force commitments in any other products in the near term? And second question is can you provide perhaps some more specific timing in terms of when we can expect to see Phase III data for malignant melanoma?
Let me start with the sales first question. First of all, just to make it clear, we are not decreasing the support that we are giving to ABILIFY. ABILIFY is a products doing extremely well in the marketplace, growing much faster than the market and gaining market share versus sole competitors. So, we're obviously not decreasing our support to that product. It is only a difference mix of support between us and Otsuka that we are providing.
So, what we decrease in terms of sales force support, Otsuka will provide or is providing in strict coordination with us. So nothing to do with productivity there, it is only an implementation of an agreement we have with Otsuka pharmaceuticals.
As far as the rest of our sales force in the U.S., I think we have reached a balanced situation for our DDMAC sales force. We have seized it to support PLAVIX, until we have PLAVIX in the marketplace, to launch ONGLYZA and to provide a limited support to our product in this part of the country where it is needed. So, we do not expect if we continue to deliver successful performance of our products, and the new products to go for major changes in our sales force structure.
So Eric, on our Phase III first line advanced melanoma study, with ipilimumab in combination with dacarbazine, this is a survival study, so it's event-driven. All we can say is we're expecting results sometime in 2010, but it's event-driven and I can't predict exactly when that's going to occur right now.
Thanks everybody for your questions. I'll turn it to Jim for closing comments.
Thanks, John. We continue to deliver broad-based sales growth, really underlying our excellent commercial execution. As Lamberto just said, we're committed along with our partner AstraZeneca to making ONGLYZA, a successful commercial product. I believe we've had culture of change here at Bristol-Myers Squibb and continuous improvement with a focus on cost management as an accepted concept.
It delivers significant improvements as you've seen in both gross margins and pretax margins and finally this outstanding cash flow performance. We have a growing cash balance, a robust pipeline and we'll continue to supplement that pipeline through the String of Pearls.
In summary, Bristol-Myers Squibb is a company that delivers on its commitments. We will continue to do so in the future. Thanks very much for your attention and questions today.
This does conclude today's conference. We do thank you for your participation. Have a nice day.
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