Seeking Alpha
We cover over 5K calls/quarter
Profile| Send Message|
( followers)  

Baxter International Inc. (NYSE:BAX)

Q1 2014 Earnings Conference Call

April 17, 2014 8:30 AM ET

Executives

Mary Kay – Corporate VP, IR

Bob Parkinson – Chairman and CEO

Bob Hombach – Corporate VP and CFO

Ludwig Hantson – Corporate VP; President, BioScience

Analysts

David Lewis – Morgan Stanley

Mike Weinstein – JPMorgan

Larry Keusch – Raymond James

Matt Miksic – Piper Jaffray

David Roman – Goldman Sachs

Josh Jennings – Cowen and Company

Kristen Stewart – Deutsche Bank

Bruce Nudell – Credit Suisse

Derrick Sung – Sanford Bernstein

Operator

Good morning ladies and gentlemen and welcome to the Baxter International’s First Quarter Earnings Conference Call. Your line will remain in a listen-only mode until the question-and-answer segment of today’s call. (Operator Instructions) As a reminder this call is being recorded by Baxter and is copyrighted material. It cannot be recorded or rebroadcast without Baxter’s permission. If you have any objections, please disconnect at this time.

I would now like to turn the call over to Ms. Mary Kay Ladone, Corporate Vice President, Investor Relations at Baxter International. Ms. Ladone, you may begin.

Mary Kay Ladone

Good morning, everyone and welcome to our Q1 2014 Earnings Conference Call. Joining me today are Bob Parkinson, CEO and Chairman of Baxter International; Ludwig Hantson, President of BioScience; and Bob Hombach, Chief Financial Officer.

Before we get started, let me remind you that this presentation, including comments regarding our financial outlook, new product developments and regulatory matters, contain forward-looking statements that involve risks and uncertainties, and, of course, our actual results could differ materially from our current expectations. Please refer to today’s press release and our SEC filings for more details concerning factors that could cause actual results to differ materially.

In addition, in today’s call, non-GAAP financial measures will be used to help investors understand Baxter’s ongoing business performance. A reconciliation of the non-GAAP financial measures being discussed today to the comparable GAAP financial measures is included in our earnings release issued this morning and available on our website.

Now I’d like to turn the call over to Bob Parkinson.

Bob Parkinson

Thanks Mary Kay. Good morning. Thank you all for calling in. As you read in the press release issued earlier this morning Baxter reported strong financial results for the first quarter which exceeded expectations and we’ve also confirmed our full year 2014 guidance. Adjusted earnings increased 9% to $1.19 per diluted share and worldwide sales excluding currency increased 16%. Excluding Gambro and foreign currency, Baxter’s sales advanced 5%. Positive momentum is building and Baxter is off to a strong start in 2014. I’m pleased that we delivered strong financial results continued to enhance our flexibility to invest for future growth and position the company for sustained performance and success.

Our new product pipeline is focused on a number of programs that improve the quality of care and address key high potential areas of unmet medical needs. Some recent highlights in the quarter include FDA approval of a label change allowing for a shorter total infusion time for GLASSIA, a chronic augmentation and maintenance therapy for hereditary emphysema and under diagnosed condition characterized by a low level of alpha-1 protein in the blood.

This change enhances convenience and allows for less overall time for the entire infusion process from preparation to administration. Also success in meeting the primary efficacy endpoint in the phase III study of BAX 111. The first stand-alone recombinant treatment in clinical development for von Willebrand Disease for a on-demand bleeding events.

We expect to file for regulatory approval in the United States before the end of 2014. We also intend to pursue a study for a prophylaxis indication. Baxter also presented interim data that the European association for Haemophilia and Allied Disorders from our first year observation from the ADVATE HaEmophilia A Database study, a four year outcomes registry of Hemophilia A patients. A total of 562 patients have been enrolled to-date. And the data supports the clinical experience of prophylaxis treatment with ADVATE, showing 51% experienced no bleeds during the one year of treatment.

Also in the quarter, we executed a new exclusive agreement with Xenetic Biosciences for the development of BAX 826, a recombinant Factor VIII therapy for hemophilia A utilizing Xenetic’s proprietary polysialic acid technology. BAX 826 is currently in preclinical development as a treatment that maybe administered less frequently potentially at once weekly intervals without compromising efficacy.

At lastly during the quarter, the company acquired Chatham Therapeutics including their developmental Gene Therapy preclinical hemophilia A and ongoing hemophilia B programs and the potential application for additional hemophilia treatments. As you may recall Baxter and Chatham are currently in a phase I, II trial evaluating Chatham’s Biological Nano Particle platform as the potential treatment for hemophilia B. The vector-based technology which provides a mechanism for the patients on liver to begin producing Factor IX following a single dose of the genetically engineered treatment as the potential to redefine the concept of longer acting therapy.

And finally in the first quarter as you all know we reached a significant milestone in our company’s history with the announcement of our plans to create two separate independent global healthcare companies, one focused on developing and marketing innovative biopharmaceuticals and the other on life saving medical products. This decision supports Baxter’s evolution and underscores our commitment to ensuring our long-term strategic priorities remain lined with shareholders best interest, while creating value for patients, healthcare providers and other key stakeholders.

The two businesses operate in distinct markets with the corresponding underlying fundamentals and each possess unique and compelling growth prospects, investment requirements and risk profiles. The spin-off will create two well capitalized independent companies with strong balance sheets, investment grade profiles and disciplined approaches to capital allocation. And other benefits of this include one greater management focus on the distinct businesses of biopharmaceuticals and medical products, the ability to more effectively commercialize new and existing product offerings.

The ability to drive innovation across the franchises and allocate necessary resources to the areas presenting the highest growth potential and the flexibility to pursue respective growth and investment strategies resulting in revenue acceleration, improved profitability and enhanced returns. We look forward to closing this transaction by mid-2015 and preparations are already been made to affect in efficient and orderly transition to position both companies to capitalize on the exciting opportunities that the future holds.

So with that, I would like to ask Bob at this point review financial results for the first quarter and also discuss our guidance for the remainder of 2014. Bob?

Bob Hombach

Thanks Bob and good morning everyone. As Bob mentioned adjusted earnings per diluted per share in the first quarter advanced 9% to $1.19, which exceeded our previously issued guidance range of $1.06 to $1.09 per share. These financial results include an after tax gain of $35 million or $0.06 per share associated with the sale of certain equity investments, which will largely be reinvested in the business over the balance of the year.

As we mentioned in the press release GAAP earnings of $1.01 per diluted share included after tax special items totaling $96 million or $0.18 per share for intangible asset amortization and cost associated with the integration of Gambro business development and business optimization initiatives. The business optimization initiatives include additional cost related to the decision to explore strategic options for the vaccines and cell therapies R&D programs.

Now, let me briefly walk you through the P&L by line item before turning to the financial outlook for 2014. Starting with sales, worldwide sales were approximately $4 billion advanced 15%. On a constant currency basis sales rose 16% and exceeded our guidance range primarily due to strong demand for hemophilia products as well as the accelerated timing of vaccine milestone payments and a renal PD tender. Excluding Gambro revenues of $400 million which were in line with expectations Baxter sales rose 5% on a constant currency basis.

In terms of individual business performance, Global BioScience sales of more than $1.6 billion advanced 5% in the first quarter. On the constant currency basis sales increased 6%. Within the product categories, hemophilia sales of $827 million increased 8% or 9% on a constant currency basis. This is the result of capitalizing on our global leadership position and brand differentiation broadening our portfolio with new product launches like RIXUBIS for the treatment of Hemophilia B and expanding access to care particularly in emerging markets.

Specifically global demand for ADVATE remain strong as we continue to benefit from our label expansion improved prophylaxis penetration and shipments to Brazil as part of our ongoing collaboration with Hemobrás to enhance access to Recombinant factor A therapy.

We have now converted more than 30% of the total patients in Brazil and we expect to generate sales of more than $100 million in 2014. In addition, global demand for FEIBA also remained robust resulting in double digit sales growth in the quarter.

In BioTherapeutics sales of $502 million declined 1% on both a reported and constant currency basis. Growth in the U.S. of 7% was a result of improved cost availability and growth of the Immune Globulin therapies albumin and alpha-1 treatments. This strength was more than offset by lower sales in international markets as a result of lower albumin sales in China and decisions to exit certain markets due to previous supply constraints.

Sales in BioSurgery of $176 million increased 2%, on a constant currency basis sales rose 3% driven by demand for surgical sealants like TISSEL and COSEAL. As you know both of these products is tied directly to growth in surgical procedures.

Finally, vaccines revenue totaled $103 million and increased 23%. Sales advanced 25% on a constant currency basis driven primarily by accelerated milestone payments of approximately $40 million related to ongoing government collaborations for the development of influenza vaccines.

In medical products global sales exceeded $2.3 billion and increased 22%. On a constant currency basis sales advanced 24%. Excluding Gambro and foreign currencies medical product sales grew 4%. Within the product categories, renal sales totaled $991 million including Gambro sales of $400 million. Excluding Gambro and foreign currency renal sales increased 4%. This was a result of strong PD growth of 9% supported by strong patient gain in the U.S. and emerging markets that also benefit from the timing of certain tender sales of more than $15 million. This momentum was partially offset by the divestiture of the CRRT business.

Sales in the fluid system category of $757 million increased 2% or 3% on a constant currency basis. Performance continued to be driven by price improvements for the injectable oncology drug cyclophosphamide which more than offset lower sales of drug delivery systems.

Especially pharmaceuticals which includes our inhaled anesthetics and nutritional therapies posted sales of $367 million reflecting an increase of 1%. Sales rose 2% on the constant currency basis as strong global anesthesia growth offset lower sales of certain nutritional therapies resulting from ongoing supplier shortages.

Finally sales in BioPharma solutions which is our pharma partner business totaled $228 million with close to 1% on a reported basis or 4% on a constant basis. This performance attributed primarily to the easing of supply constraints which impacted orders and shipments in the first quarter of last year.

Turning to the rest of the P&L, gross margin in the quarter was 51.0% compared to 51.7% last year. Margin expansion in the base Baxter business was more than offset by the impact of lower margin Gambro business and in foreign currency.

SG&A totaled $903 million and increased 16% with the Gambro acquisition accounting for the vast majority of the growth. Excluding Gambro SG&A increased 2% as leverage close to arise and benefits associated with our business optimization initiatives. This was partially offset by select investments and promotional and marketing initiatives for new product launches and with the international market to enhance our global presence.

R&D spending in the quarter of $282 million increased 15% versus the prior year. Excluding Gambro R&D rose 2% and continuous to be driven by investments we are making to advance a number of programs in our pipeline, including those in our leading hemophilia franchise, programs to leverage our expertise in the therapeutic areas of hematology, oncology and immunology and investments in renal therapies aimed and improving patient outcomes across the continuum of care.

The operating margin in the quarter of 21% is lower than last year’s operating margin of 22%. However, excluding Gambro, leverage in the base Baxter business was also been an operating margin improvement of 80 basis points to 22.8% versus the prior year. Interest expense was $43 million which reflects recent debt issuances to fund both the Covington plasma manufacturing site and the Gambro acquisition.

Other income totaled $41 million compared to income of $30 million last year. This includes $44 million of pre-tax gains associated with the sale of certain equity investments. As referenced earlier on an after tax basis, this equates to benefit of $35 million or $0.06 per share with largely reinvested in the business over the balance of the year. The tax rate was 21.4% for the quarter in line with our expectations and as previously mentioned adjusted earnings per diluted share advanced 9% to $1.19.

For the first quarter, cash flow from operations was very strong and totaled $559 million. This reflects an improvement versus last year of approximately $175 million. DSO ended the quarter at 53.6 days and excluding Gambro, Baxter’s DSO was 49.9 days lower than the prior year by 3.7 days.

Inventory turns of 2.0 or lower than 2.2 turns in the prior year period due to increased plasma inventories to support strong demand and future growth. Lastly, in the first three months of this year, we repurchased approximately 3.7 million shares for $250 million or on a net basis 1.2 million shares for $123 million in line with our full year objective.

Finally, let me conclude my comments this morning by providing our financial outlook for the second quarter and full year 2014. For the full year, we continued to expect adjusted earnings of $5.05 to $5.25 per diluted share. As we know that last quarter, we are providing a lighter range, it’s been our historical practice as a number of factors and assumptions impact the outlook particularly headwinds created by cyclophosphamide competition in emerging market FX volatility.

Specifically by line item of the P&L and starting with sales, we continue to expect sales growth excluding the impact of foreign currency of approximately 9% to 10%, which includes annual sales of more than $1.6 billion for Gambro. At current foreign exchange rates, we expect reported sales growth of approximately 8% to 9%. Excluding Gambro, we expect the base Baxter sales to grow approximately 2% on a constant currency basis.

For the full year, we continued to expect gross margin for the company to decline by approximately 150 basis points in the 2013 margin of 52%. Given the strong first quarter, we expect the first half margin to be approximately 40 to 50 basis points higher than the gross margin in the second half which includes the impact of new competitive entrants.

In terms of expenses, as mentioned earlier our first quarter performance enhances our flexibility to invest in the business to drive future growth. Therefore, we now expect R&D to grow in mid-single digits and SG&A to grow in mid-to-high single digits.

We expect interest expense to total approximately $160 million and we now expect other income of approximately $40 million for the year. We expect the tax rate of approximately 21.5% and we expect a full year average share count of approximately 547 million shares, which assumes approximately 300 million in net share repurchases.

From a cash flow perspective, we continue to expect to generate cash flow from operations of approximately $3.5 billion. We expect capital expenditures of approximately $1.8 billion, which includes Gambro and the investments we are making to enhance our plasma manufacturing footprint in Covington, Georgia.

Let me move to sales and expand our assumptions for the two businesses and the major product categories which are very consistent with our original guidance.

Beginning with medical products on a constant currency basis including the contribution of Gambro, we expect sales growth of approximately 13% to 14%. Excluding Gambro, we expect sales from medical products to grow 0% to 1%. Specifically, we expect renal sales to grow approximately 40% including the benefit of continued PD penetration, the incremental revenue contribution from Gambro as well as commercial synergies.

We expect fluid system sales to decline 3% to 5% reflecting the impact of lower cyclophosphamide sales. As we mentioned, if we have two competitors by mid-year, the sales and pre-tax impact would equate to $150 million to $200 million. We expect specialty pharmaceutical sales, which includes our nutritional therapies and inhaled anesthetics, to grow in the 3% to 5% range. And we now expect our BioPharma Solutions sales to be flat for the full year.

For BioScience, we project sales growth excluding foreign currency at 3% to 4%. Our outlook includes growth of 4% to 5% in our hemophilia franchise. Well we continue to expect to increase competition for recombinant factor VIII therapies in the second half of this year, performance will be fueled by underlying global demand for ADVATE, convergent to recombinant therapy in Brazil, new tender awards, as well as the benefit from new product launches, including RIXUBIS, OBI-1 and FEIBA prophylaxis.

For the BioTherapeutics franchise, we continue to expect growth of approximately 4% with sales of albumin in China and immunoglobulin therapies ramping up particularly in the second half of the year. In BioSurgery, we expect growth in the 5% to 7% range. And finally, given the first quarter performance, we now expect our vaccine sales to decline in low single-digits.

As mentioned in our press release, for the second quarter, we expect earnings per diluted share excluding special items of $1.18 to $1.22, which reflects the timing benefits that were accelerated and recorded in the first quarter. We expect sales growth, excluding the impact of foreign currency, of 12% to 13%. Excluding Gambro, we expect the base Baxter sales at constant currency rates to grow approximately 2%.

Thanks. I’ll now open up the call for Q&A.

Question-and-Answer Session

Operator

Thank you. We will now begin the question-and-answer session. (Operator Instructions) I would like to remind participants that this call is being recorded and a digital replay will be available on Baxter International’s website for 30 days at www.baxter.com.

Our first question comes from David Lewis of Morgan Stanley. Your question please.

David Lewis – Morgan Stanley

Good morning.

Bob Parkinson

Good morning.

David Lewis – Morgan Stanley

Bob, simply start off on the financial guidance for the second quarter, obviously a very nice start to the first quarter year on earnings, some of that was the gain but just the underlying business was stronger and margins are good. Can you talk us about what factors change here in the second quarter, because that earnings number is little lower and you would have expect to get assuming the strength in the first quarter?

Bob Parkinson

Certainly, David. Yes, there are definitely an unusual number of timing impacts here that have benefited the first quarter to the determent of the second quarter. And I would gage that in a $0.05 to $0.06 range. And, so let me walk you through those, it’s really two main things. We have a collaboration on the vaccine side to do a tech transfer related to our Vero cell technology, we expected milestones to occur later in the year and including in the second quarter. The good news is, those were completed a bit early and fully recognized in the first quarter, but that does create about $0.03 of upside in the first quarter at the expense of the second quarter.

And then secondly, again along the lines of revenue recognition in terms of timing of when tender sales occur, we have a large tender in the PD franchise that we expected in the second that occurred in the first. The combination of those two and a couple other things really is what drove the strong performance in the first quarter. I would also mention that as you know the gains in the first quarter that we highlighted there of $0.06 related to the two minority investments that were sold. We also incurred incremental FX in the first quarter that dampened the impact of some of these timing benefits primarily related to Argentina, and other emerging market impacts including related to the Gambro business.

So, a lot going on between the first and second quarter, I think if you look at the two of them combined it will give you a better sense of where we’re at and that’s largely why if we looked at the full year, we’d maintain our full year guidance, again a lot of volatility potentially we have ahead of us with cyclo and FX but operationally a very, very solid start.

David Lewis – Morgan Stanley

Okay.

Mary Kay Ladone

And David, I would also add that in plasma, we have some plasma tender timing as well that impacts the second quarter versus the prior year. Those tenders are going to occur more in the third and fourth quarter this year versus some of the major tenders that occurred in the second quarter last year.

David Lewis – Morgan Stanley

Thanks, Mary Kay. Very helpful. And then, maybe just a follow-up. The key strength where we’ve seen in the last couple of quarters has been but still and I imagine that’s a surprise for certain investors. So, if we think about that strength, in the last two quarters, obviously it’s coming out of the U.S. markets. And there is really two factors going on this quarter, it feels like one is Brazil and there maybe some of the early product launches like RIXUBIS, but you talked about Brazil being about $100 million in 2014. Frankly, based on the trend-line out of 2013 in the first quarter result, $100 million just seems low. So, is there anything going on in terms of the timing of Brazil or maybe you can give us the mix of the factors contributing to U.S. in the affiliate strength during the first quarter. Just seems that, that $100 million number could go a lot higher in 2014?

Bob Parkinson

Yes, it could go somewhat higher David. I would tell you in the first quarter, though the contribution from Brazil was not outside in the sense of what the trend would need to be in order for us to deliver something just north of $100 million. So, we’re very pleased with the progress we’re making. And so, that certainly is a contributor, but frankly ADVATE continues to do well in many other international markets including markets like Japan where we’ve had very strong growth over the last couple of years.

David Lewis – Morgan Stanley

Okay. Thank you, very much.

Operator

Thank you. Mike Weinstein of JPMorgan is on the line with the questions. Please state your questions.

Mike Weinstein – JPMorgan

Thanks. Question on clarifications on the guidance. So, the – it looks like you took another price increase about 30% on cyclophosphamide in January. Can you just maybe clarify what you’re assuming in the second quarter relative to competition, I haven’t seen anybody announcing it then. Just want to clarify what you’re assuming? And then second, look at guidance for the year, I assume you weren’t assuming the $0.06 gain in the original guidance. So, why should we move up number by $0.06 given the gain here this quarter? Thanks.

Bob Parkinson

Okay. Couple of things, so on cyclo, I’d like to first point out, we in our Q1 guidance did not assume any competition nor do we see any competition and results in the first quarter were basically as expected. So, cyclo was not a contributor to our performance in the first quarter relative to our guidance. At this point, we’re not expecting competitive entrants though very late in the second quarter, so not much impact in the second quarter either but certainly in the back-half then depending on when the second and or third enters in, that will determine how that plays out for the remainder of the year, but for the second quarter again not expecting significant competitive impact on cyclo.

As to the price increase, we did take a price increase, obviously there are different channels and different customer relationships, I wouldn’t say with across the board at the same level, but we did take a price increase in the first quarter.

Mary Kay Ladone

And then the gain Bob.

Bob Parkinson

As it relates to the gain, yes. And so, as I mentioned there are some aspects here as well in the first quarter FX being 1. But, as we look at the balance of the year in some of the areas that we want to ensure reposition ourselves to generate the best success. We are looking at R&D and SG&A reinvestment here that over the balance of the year, we’re not going to be taking that gain to the bottom-line.

Mary Kay Ladone

And we did change our guidance...

Mike Weinstein – JPMorgan

I have a question for Bob Parkinson. And I really want to focus on strategy for the medical product side of the business close within. Can you just talk little bit about what drives that business and I’m really thinking not only about the top-line but about margins obviously it’s going to be a big regions that the next pertaining two months with Cyclophosphamide going away. But once that’s done, what drives there when your top-line, but what drives margins there and what periods kind of the story beyond this be currently underlying growth we’re seeing right now? Thanks.

Bob Parkinson

Yes. Okay, Mike. So, let me not be too lengthy in my response because there is not a simple response. So let me start with the Gambro acquisition. Which as we discussed before, it allows us to participate in a leadership role in a large global markets that we believe will grow in the 5% to 6% range long-term. And so, the acquisition of Gambro, the expansion of our presence augmenting our PD business to address treatment of end-stage renal disease a significant long-term growth platform for the newly defined medical products business, but I think you all understand that.

Within the traditional medication delivery business if you will, again our plans are to intensify focus in those product categories that are higher growth than higher margins. So, anesthesia would be one parenteral nutrition would be another. Also, there continue to be opportunities to improve margins in our core global IV business in terms of manufacturing efficiencies, productivity, supply chain productivity in the like. So, again there is not a simple answer to that. I think there is a lot of levers might that can be pulled to enhance margin over the long-term in the newly defined Baxter if you will going forward.

And I would also say that as we’ve accelerated business development activity over the last couple of years, certainly it is our plan to continue that as we go forward with the new company. So, I think the – I think the – with increased focus which is one of the primary rationales behind the decision to spin-off the Biopharmaceuticals business with an increased focus globally frankly I think will allow us to address a number of margin improvement opportunities over time.

Mike Weinstein – JPMorgan

Great. Thank you, Bob.

Bob Parkinson

Thank you.

Operator

Thank you. Our next question comes from Bruce Nudell of Credit Suisse. Your line is now open.

Bob Parkinson

Bruce, are you there?

Operator

Please check your mute button sir. And we’ll move on to our next question. Our next question comes from Larry Keusch of Raymond James. Your line is now open.

Larry Keusch – Raymond James

Hi, good morning. Just to perhaps for Bob Hombach. Bob you obviously mentioned in your prepared comments that the underlying Baxter gross margin has been improving, I believe you said up 80 basis points year-over-year. So, I just want to dig into that and fully understand what is driving those improvements there because that’s pretty impressive? And then, secondly if we could just get an update on where you guys stand with the large volume infusion pumps?

Bob Hombach

Sure. So, yeah the comment was around operating margin and there is obviously a number of factors there in the base Baxter business FX, calling FX to the side which has tended to be more of a headwind in the last couple of quarters. Mix, certainly placed in ADVATE strong hemophilia sales here for the quarter. The business optimization efforts that we put into not only this year but last year as well are certainly playing into that. The vaccine milestones come with fairly high margins as well. So, those being recognized here in the first quarter were beneficial as well. And we are starting to see the benefits of the Gambro synergies starting to come into the -I know we’re talking about the base Baxter business but overall that is something that’s going to drive our margins throughout the rest of the year.

Larry Keusch – Raymond James

Okay, great. And then on the pump side, where do we stand there?

Bob Hombach

So, update on the pumps, as we had filed the necessary documents and are waiting for the review to be complete and we expect to hear something about in middle of this year, so I don’t think there is really any other update at this point.

Larry Keusch – Raymond James

Okay, great. Thanks very much.

Operator

Thank you. Our next question comes from Matt Miksic of Piper Jaffray.

Matt Miksic – Piper Jaffray

Hey, thanks. Good morning. Wanted to ask just Bob if I could, Bob Hombach on the gain and the FX loss you mentioned the FX, the incremental FX kind of offsetting the gain. I guess we were looking for about a dime of FX impact this year. Did this push you closer to $0.15 or can you give us anymore color on to just how that offsets that number? And then I have a couple of quick follow-ups.

Bob Hombach

Yes. So, Matt actually we characterize them more like a $0.15 at the time we gave guidance for the full year, we had FX at about $0.15 headwind. And in fact it’s going to be a little bit higher than that given the Argentina situation as well as how things are playing out. I think I would note about FX is historically a stronger euro would be beneficial to Baxter given the size of our business there and a overall global manufacturing footprint. As we bring Gambro into the fold though, the vast majority of their manufacturing a lot of their cost base is in euro. And so, we’re actually like we benefit less from a stronger euro in the near-term, but it did increase our exposure to all other currencies outside the U.S. given the footprint they have. And so as emerging market currencies have continued to struggle a bit, our current set up here with Gambro given the stronger euro and the weaker emerging market currencies actually creates incremental FX downsides in that original $0.15 assumption.

Matt Miksic – Piper Jaffray

That’s helpful. And then the other comment, I think that Bob or one of your mate here in the beginning of the call was around sort of synergies or sort of the broad portfolio of hemophilia products of course FEIBA launching in the quarter, appropriate FEIBA and OUS strength. I guess, can you tell us little bit about anything that any sort of -any sort of synergy effects of launching these multiple therapies into this general category whether it’s for hemophilia B, hemophilia A or the treatment of inhibitors as in FEIBA that you’re seeing develop in the market either in the U.S. or international? And then I have just one last quick one.

Bob Hombach

So a couple of things, I want to come back to the comment that was made on the strong demand x U.S. for the hemophilia. I must add to that that we also continue to see strong demand for ADVATE and FEIBA in the U.S. And although it’s not reflecting the sales numbers still there were some inventory adjustments versus first quarter of last quarter. So, we stick to our full guidance and believe that the U.S. is also showing a very strong demand.

As far as the launches is concerned, the launches are staggered geographically RIXUBIS at this moment a U.S. launch company as you know we still needed the application end of last year both in Europe as well as Japan and so we expect to launch RIXUBIS ex-U.S. by the beginning of 2015. As far as the launch is -are concerned, so as this prophy is on track, we launched this in 2012, we’ve had more than 500 patients on ADVATE, FEIBA prophy is on track. We launched this in the beginning of this year and it is ahead of expectations and it’s also reflected in our numbers, and the RIXUBIS launch as I said in the U.S. is on track. We’ve converted quite some patients, so we really pleased with the launches in our hemophilia franchise.

Matt Miksic – Piper Jaffray

Great, and then Ludwig the last one actually is for you. Just if you – we’re all looking at competition – to throw the competition in the back-half in hemophilia and of course also to some top-line indication of the 855 data hopefully on mid-year or third quarter. And I’m just wondering, you’ve said us before that if you did receive anti-inhibitor in that data, that you would announce it as you receive data shortly thereafter. If you could help us understand was the trial fully enrolled in say November or wherever it was, is how far along here do we need to be to feel like or can we feel like there is any sort of comfort level that okay, we’ve gotten this far in with anti-inhibitor, inhibitors usually happen in whatever the early part of that therapy. Any color you could provide us is to whether we should be feeling more comfortable as we get to May or June or July or what’s the timing would be very helpful? Thanks.

Ludwig Hantson

Yeah so I’m not going to speculate on the outcome of the study, but as far as timing is concerned yes we did enrolled less patients in this study end of last year, it is a six month study so that will give you some idea of when the last patient, last assessment will be and correct we have not seen anti-inhibitors. We planned to release the data third quarter of this year with a submission before the end of this year.

Matt Miksic – Piper Jaffray

Thank you so much.

Operator

Thank you. Our next question comes from David Roman of Goldman Sachs.

David Roman – Goldman Sachs

Thank you and good morning everyone. First question was on the Biotherapeutics business just on the ramp in the back-half of the year. Can you maybe just enumerate some of the details that are supporting that I presume on albumin its obtaining the licenses in China, but you maybe update us on the Sanquin as well in that question?

Bob Hombach

With respect BioT if you did see a negative growth for international in the first quarter, we believe that this is going to change moving forward with particular guidance that we give for the full year for BioT which is plus 4%. So you will see an uptake in growth in the next quarters. There is an impact of albumin especially on the China, IG International will pick up also in the next quarters, so that’s what where we are.

Bob Parkinson

Yeah and we do expect to start meaningful shipments to China and albumin in the second quarter David, we already have one of the two licenses renewed and so, at this rate we expect to sell almost as much albumin in China this year as we did last year.

David Roman – Goldman Sachs

And then the ramp in IG is that coming from the contribution from IQ or ramp up in production somewhere else?

Bob Hombach

It will primarily come from the IG business and the substitute business not from IQ, as we said the ramp up for this for IQ, ex-U.S. as well as U.S. will be minimal, but there will be some contribution, with respect to your question on Sanquin – Sanquin will not have an impact on the 2014 numbers.

David Roman – Goldman Sachs

Okay great. And…

Mary Kay Ladone

I would just add David; we didn’t expect Sanquin to impact 2014 as the capacity won’t come on until early next year.

David Roman – Goldman Sachs

Got it, okay. And then on the renal business, I think you said 4% organic growth that included the tender win, but I know its early in the Gambro integration process, but can you give us some sense as to what the magnitude of commercial sort of clinical revenue synergies you might be able to realize in that deal going forward and can that business get to sort of a sustainably ex these had a one-time tenders of 4% to 6% growth rate over time?

Bob Parkinson

Yeah David, Bob Parkinson here. First of all yes is the answer to your – the last part of your question that clearly is our expectation. It’s a little bit early in the game to quantify commercial synergies although I would say, the first quarter for Gambro and revenue came in virtually spot on our model and of course the rest of the renal business, the legacy renal business was even stronger than our forecast. And we’re beginning to see early stages of synergies, one example, would be certain tenders where our ability to bid more broadly with product offerings and all the categories allow us to compete were previously we’ve been able to -unable to do that. So, we anticipate that we’re going to be able to experience more things like that as we go forward. But certainly the long-term projection the growth of Baxter’s renal business broadly defined both the legacy business and Gambro is going to be very much in line with what I said.

David Roman – Goldman Sachs

Okay, thank you very much.

Operator

Thank you. Our next question comes from Josh Jennings of Cowen and Company.

Josh Jennings – Cowen and Company

Hi good morning, thanks for taking the questions. Just a follow-up on David’s question, is with the Gambro acquisition I think Bob you said $400 million this quarter and PD growth of 9%. Are you seeing some early cannibalization of your historic hemodialysis business and is there any qualification there?

Bob Parkinson

Well our historic hemodialysis business is, very modest, so I don’t think there is any cannibalization that we’re seeing that at all, Bob I don’t know if you have any.

Bob Hombach

Yeah of course, well two things I would say, we did mention that the CRT divestiture that was about a $55 million business that we had to divest as part of the closing the deal. So that will be throughout 2014 from a growth rate perspective. And while there are some modest impacts, because largely our HT business previously was through was self acting as the distributor for other parties and now that we’ve acquired Gambro that will – that will tail-off overtime, but in 2014 no significant impacts that we’re expecting on those relations.

Bob Parkinson

Josh I think it’s important for you and everyone to understand to that you raised a question of cannibalization, in terms of our legacy home presence with PD and of course our aspirations to launch our new home hemodialysis systems. We really believe that our broader position resulting from the Gambro acquisition will actually enhance our ability to penetrate the market on both our traditional PD business as well as support the home HT launches as those cascade out overtime. So, we see that as a positive synergistic effect.

Josh Jennings – Cowen and Company

All right, great thanks for that. And then just one for Ludwig, just on the BAX 111 approval, can you just help us frame the global von Willebrand factor market and I’ll stop there. Thanks a lot.

Ludwig Hantson

Thanks Josh and maybe I should correct you, we didn’t get approval. Your question is 111?

Josh Jennings – Cowen and Company

Yes.

Ludwig Hantson

So, we got the phase III results and we released those early this week, so we’re really pleased with the results, the products a couple of things on the product it could be the first recombinant von Willebrand and we received orphan status in U.S. and Europe. It’s a pure von Willebrand molecule with a ratio of 100:1. The phase III study was very positive since the 100% of the patients had positive response on the efficacy rating scale, which we read on with the FDA. As far as the market is concerned currently it says $300 million to $400 million, it’s a 100% plasma. But I do see, taking this opportunity to grow this market to increase diagnosis – diagnosis rates are really low as well as prophy used, since the prophy used is really is about 5% in total and when you look at the type III severe patients it’s only a 20%.

So, we look at this market as a potential market where we continue to make difference in those patients life and increase the value.

Operator

Thank you. Our next question comes from Kristen Stewart of Deutsche Bank. Your line is now opened.

Kristen Stewart – Deutsche Bank

Hi, thanks for taking the question. Just to clarify back on Mike’s original question. Was the gain on the sale of the investment contemplated in your guidance that you issued back in January?

Bob Hombach

No, not.

Kristen Stewart – Deutsche Bank

Okay. And then just on…

Mary Kay Ladone

Kristen, can I just add to that as well because, I think Mike’s question, I try to jump in but we did increase the guidance in terms of our R&D spend. We did have an acquisition in the quarter Chatham which is going to increase some R&D on this as well as some other things that are planned as we accelerate some program. So, guidance there went up as well as guidance in SG&A.

Kristen Stewart – Deutsche Bank

Okay. And these investments, have you disclosed or is there any filing to share which what exactly you sold and why sold them. I know you guys have had a portfolio of investments.

Bob Parkinson

Well, actually these were much more -much older investments going back 12 to 15 years, there were minority positions we had the underlying companies made an independent decision to sell. And so, we really had no impact on the timing and they both happen to happen in the first quarter and they were sold to private firms. One of them was GHX which is an EDI platform that a number of large healthcare companies got together to form a contortion again 10, 15 years ago and so that was recently sold to again to a private firm. So, that’s really the extend of it.

Kristen Stewart – Deutsche Bank

Right, the gain was nothing in your control in terms of the timing, it was just simply these underlying companies were sold to you?

Bob Hombach

Yes, they own less than 10%, I think both, we had a very little say on timing.

Kristen Stewart – Deutsche Bank

Okay, great. And then you’d also mentioned, I guess Bob you had mentioned kind of the parenteral nutrition business and your interest there. How do you just think about, I guess expanding that business, would you consider to run acquisitions kind bolster up your nutritional franchise. And does I guess the split off I guess in general just make it a little bit more challenging to do M&A over the next year or so?

Bob Parkinson

I mean this certainly in terms of -in terms of the financial strength, clearly we have the ability to continue the kinds of acquisitions that we’ve done in the recent past. I actually think in some ways Kristen after the split, we might have been have more latitude and flexibility to pursue some things given the nature of the new Baxter without the biopharmaceutical business that would be more aligned with expectations of shareholders. So, clearly business development acquisitions are very much part of our strategy at the new Baxter going forward.

And the area parenteral nutrition, specifically I think is a significantly under penetrated market globally. And I think the opportunity there is really more internal investment to cultivate the growth of that market whereas you know we’re a leader in that market today. Whether specifically there are acquisition candidates within parenteral nutrition not really going to comment it is an evident to me that there are, but the key thing is the underdeveloped nature of that market, I think with the increased focus and associated investment and opportunity to accelerate the growth of that product category.

Operator

Thank you. Our next question comes from Bruce Nudell of Credit Suisse. Your line is now open.

Bruce Nudell – Credit Suisse

Good morning. Thanks for bearing with me, phone problems here. Ludwig, it’s been very hard to get an extension of the half-life refractory. And the zoonotics thing, it sounds like it is the departure from that and could you basically explain why you think it might work and likely to success?

Ludwig Hantson

Well, first of all this is early stage, this is still pre-clinical. And the PSA I think we will extend for the pioneer of highly tested about the same. Maybe the difference here is that it’s biodegradable in our pre-clinical studies with the monkeys, we showed a prolongation by a factor of more than two compared to ADVATE. We’ve been wanting to see what it means in the clinic and what is the chances that you will go all the way, I think you know the signs of biopharmaceuticals in the pre-clinical we believe that it has a lot of value but puts us in the studying in of clinical studies will show we can repeat the execute.

They went from back to maybe what is the most important thing here it is for us it is a belief towards and it’s not about extending the half-life, it is about making sure that we have zero bleeds and you get zero bleed spot extra levels that are high enough, constantly not from the peak and is from that perspective that our approach on gene therapy in hemophilia, we believe could be disruptive and that’s why we want to be a leader in the technology as well.

Bruce Nudell – Credit Suisse

Great. So, and my follow-up is just very tactical with regard to saying when I know there were regulatory issues that were out there, how are they looking, is it likely that this will be coming on line in 2015 kind of in a seamless way as planed?

Bob Hombach

Well, we are working with Sanquin on the question, as much as we can. As we also said, the Sanquin volumes are not reflected in our 2014 numbers. And we believe that the guidance that we gave on our ability to grow with the market 6% to 8% that will not be affected for the next couple of years irrespective of the ultimate Sanquin. But we believe that we should be able to work with Sanquin to those questions in our next year most likely have that inputs.

Bruce Nudell – Credit Suisse

Thanks so much.

Mary Kay Ladone

And we have time for one more question.

Operator

Yes, ma’am. And our final question comes from Derrick Sung of Sanford Bernstein.

Derrick Sung – Sanford Bernstein

Hi, good morning. Thanks for fitting me in. Just starting with a quick question here, I wanted to – have you remind us of your expectations for SUPRANE generic competition and what is factored in your guidance for this year for that?

Bob Hombach

Bob, you want to take?

Bob Parkinson

Yeah, we had a modest competitive impact put into our original guidance and given the latest information that we have, we don’t expect much of an impact here. So, it’s largely competitive and out of our guidance here for Suprane. But the delta between our original guidance and where we’re at today is around $10 million or so, if not significant.

Derrick Sung – Sanford Bernstein

Okay great that’s very helpful. And then, my follow-up is for Ludwig on – on the long acting recombinant factor VIII market, two things there, one we’ve seen now phase III data from a number of the other competitors Nova as well as Bayer in addition talk to Biogens product. Somewhat if you kind of get your reaction that we’ve seen more phase III data come in on just kind of what you think of the long acting competition maybe how that might relate to your product? And then secondly there, one of the big questions, I mean that’s out there is how pricing in the market might change with the entering of new competitors, particularly competitors who currently don’t have a presence in the market and wanted to get your thoughts on that as well?

Ludwig Hantson

I’ll respond with the pricing question which is going to be a short answer, so I have no comments on that, so no comments here. With respect to your question on LA maybe a couple of observations. The first one is we call them long acting factor VIII products mentioned it several times that we believe that these are not long acting, these are extended half-life products. The half-life is still shorter than one day shorter than RIXUBIS half-life, and I would not call RIXUBIS a long acting product. So that’s number one.

Number two is, the – what the data shows consistently is that when we’re pushing to dosing regimen towards 5 or 7 days that the data consistently shows that ABRs the annual bleed rate increases. And then we should ask ourself the question, are we doing the right thing for the patient here. Again this is a bleeding disorder with the objective of zero bleed and is not infusion disorder.

So, my answer is that, I do believe that we are on track with what we’re doing with 855 that it is based on the ADVATE molecule that is proven that is shown to be preventive, that is shown to have consistent factor level data irrespective of the ADVATE that is being used. And I believe that we have a very strong platform to work from. So I really feel comfortable with 855 approach in addition to that as I mentioned, I believe that gene therapy could be disruptive, we are of course proof-of-concept in hemophilia B. And with the new acquisition, we are on the lead from the gene therapy perspective across the board broader than we.

So, I’m really comfortable with our strategy, the data as I said for 855 will get this done in second quarter.

Derrick Sung – Sanford Bernstein

Ludwig do you expect to this class of extended half-life products to expand prophylaxis used in hemophilia A and how much did that expand market growth?

Ludwig Hantson

I would say that prophy penetration will increase irrespective of the extended half-life products. We’ve seen this; we’ve seen a significant uptake since we launched ADVATE prophy. We should know that all label shows up to three ADVATE 3 days, and more than 50% of our patients are on 3 days or longer dosing regimen so irrespective of the entry extended half-life products I do believe that the prophy segments will increase over time.

Derrick Sung – Sanford Bernstein

Okay thank you very much.

Operator

Thank you. Ladies and gentlemen, this concludes today’s conference call with Baxter International. Thank you for participating. Everyone have a wonderful day.

Copyright policy: All transcripts on this site are the copyright of Seeking Alpha. However, we view them as an important resource for bloggers and journalists, and are excited to contribute to the democratization of financial information on the Internet. (Until now investors have had to pay thousands of dollars in subscription fees for transcripts.) So our reproduction policy is as follows: You may quote up to 400 words of any transcript on the condition that you attribute the transcript to Seeking Alpha and either link to the original transcript or to www.SeekingAlpha.com. All other use is prohibited.

THE INFORMATION CONTAINED HERE IS A TEXTUAL REPRESENTATION OF THE APPLICABLE COMPANY'S CONFERENCE CALL, CONFERENCE PRESENTATION OR OTHER AUDIO PRESENTATION, AND WHILE EFFORTS ARE MADE TO PROVIDE AN ACCURATE TRANSCRIPTION, THERE MAY BE MATERIAL ERRORS, OMISSIONS, OR INACCURACIES IN THE REPORTING OF THE SUBSTANCE OF THE AUDIO PRESENTATIONS. IN NO WAY DOES SEEKING ALPHA ASSUME ANY RESPONSIBILITY FOR ANY INVESTMENT OR OTHER DECISIONS MADE BASED UPON THE INFORMATION PROVIDED ON THIS WEB SITE OR IN ANY TRANSCRIPT. USERS ARE ADVISED TO REVIEW THE APPLICABLE COMPANY'S AUDIO PRESENTATION ITSELF AND THE APPLICABLE COMPANY'S SEC FILINGS BEFORE MAKING ANY INVESTMENT OR OTHER DECISIONS.

If you have any additional questions about our online transcripts, please contact us at: transcripts@seekingalpha.com. Thank you!

Source: Baxter International's CEO Discusses Q1 2014 Results - Earnings Call Transcript
This Transcript
All Transcripts