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The Medicines Company (NASDAQ:MDCO)

Q1 2010 Earnings Call Transcript

April 28, 2010 8:30 am ET

Executives

Michael Mitchell – Director, Communications & IR

Clive Meanwell – Chairman and CEO

Glenn Sblendorio – EVP and CFO

Analysts

Joseph Schwartz – Leerink

Cory Kasimov – JPMorgan

Lucy Lu – Citigroup

Jason Kantor – RBC Capital Markets

Operator

Good day, ladies and gentlemen, and welcome to the first quarter 2010 The Medicines Company earnings call. My name is Carissa, and I will be your coordinator for today. At this time, all participants are in a listen-only mode, we will be facilitating a question and answer session towards the end of today’s conference. (Operator Instructions)

I would now like to turn the presentation over to your host for today's conference, Mr. Michael

Mitchell, Director of Communications and Investor Relations. Please proceed.

Michael Mitchell

Thank you, Carissa. Good morning, everyone. Thank you for joining us to review The Medicines Company first quarter 2010 financial results.

I would like to remind you that this call will contain forward-looking statements about The Medicines Company that are not – purely historical, and all statements that are not purely historical may be deemed to be forward-looking statements, which involve a number of risks and uncertainties. Without limiting the foregoing, the words “believes”, “anticipates”, “plans”, “expects”, “estimates” and similar expressions are intended to identify forward-looking statements.

Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are identified in the company's SEC filings, including on Form 10-K with the SEC on March 16, 2010. Copies of our SEC filings can be obtained from the SEC, or by visiting the Investor Relations section of our website.

I would also note that during the call we may refer to non-GAAP measures, which exclude costs associated with the Targanta acquisition last year, stock-based compensation expense, and non-cash income taxes. Please refer to the non-GAAP reconciliation tables in our press release. I'll now turn the call over to Clive Meanwell, our Chairman and CEO. Clive?

Clive Meanwell

Thanks very much, Michael, and good morning to everybody.

There are three themes I'll focus on to talk about our business in the first quarter of 2010. First, Angiomax volume continued to grow this quarter, based on strong demand in the United States and international expansion. We anticipate this growth will continue, and furthermore, we believe we have multiple shots at Angiomax market exclusivity in the US beyond 2010.

Second, our performance in the quarter demonstrates that we are doing more with less and, third, our diverse portfolio of seven marketed and development products, together with early stage discovery capabilities and an active business development program provides for robust innovation and value creation going forward.

In the first quarter, hospital demand for Angiomax in the United States grew and Angiox in Europe accelerated. In the US, volume and share growth was substantial in both high risk and low risk segments of the coronary angioplasty market. Among high risk **stem E patients, our market share has grown from 18% before the Horizon trial results in 2007 to 32% as of the mid first quarter of this year.

Our non-stem E share has now increased to 43%. Among lower risk patients, we saw a share of 56% in unstable angina and 61% in stable angina. This means that during the first quarter 2010, for the first time, we reached more than 50% aggregate market share in PCI in the US, now overtaking all heparins combined, as we did some time ago for all glyco-protein 2B 3A platelet inhibitors combined.

An important emerging trend in the US cath lab is management of PCI patients in the outpatient setting, meaning that they stay in hospital for less than 24 hours. Angiomax is well suited to this situation and has enabled outpatient PCI in fact. This now represents 15% to 18% of all PCI procedures in this country and within this expanding segment, Angiomax market share has grown from 49% to 59% over the last year.

Consequent to these gains in market share, hospital demand for Angiomax this quarter reached a record high of about 182,000 vials for hospitals. And to supply these hospitals, wholesalers ordered about 175,000 vials, which means the distribution channel was reduced by 7000 vials.

With the growth in demand for Angiomax in outpatient use, we are now offering the product to qualifying hospitals at a considerable discount to [ph] our normal selling price for outpatient procedures only. This, of course, is pursuant to a government pricing program. We anticipate that this offering will continue to drive growth in the outpatient segment, but is tempered, of course, by the price discount.

Glenn will describe the expected financial impact on the quarter and the year. From a business point of view, we'll continue to drive Angiomax volume and market share in both inpatients and outpatients, because this product has now become the global standard of care for PCI in our view.

Outside the United States, volume and share growth accelerated, particularly in the high risk patient cohorts. Sales were $5.6 million, which happens to be exactly the amount of our ex-US sales for the whole of 2007. Of strategic importance is progress we made in the first quarter in the largest European PCI markets. The volume of Angiox more than doubled in Europe, with particularly strong growth in Scandinavia, Germany, and Italy, following the additional December EMEA approval of Angiox in stem-E.

Some accounts are using the products in both stem-E and non-stem-E based on the fact that Angiomax is now – Angiox is now the only anticoagulant approved in the European Union for the full spectrum of risk of acute coronary syndromes in PCI patients.

I would like to provide you with an update regarding intellectual property and regulatory exclusivity in the United States. First, concerning our litigation with the patent and trademark office, FDA, and HHS, in January 2010, we filed a lawsuit challenging the PTO's denial of our patent term restoration application for Angiomax.

The US District Court in Virginia set aside the PTO's prior decisions and instructed the PTO to reconsider its denial. The court also directed the PTO to extend the term of the Angiomax patent during these proceedings. The PTO extended the term of the patent to May 23, 2010, and shortly thereafter, issued a new denial of our application.

On the 26th of March, we again challenged the PTO's action, this time asking the same court to set aside the denial and instruct the PTO to accept our application as timely filed. Briefing on the case is almost complete and a hearing is scheduled for May 6.

Second, on the legislative front, we continue to advocate for change in the patent law. We continue to be encouraged by legislator interest in this matter. Third, we have filed lawsuits to enforce the new product patents we obtained on Angiomax last fall, and which are listed in the FDA Orange Book. These lawsuits claim that Teva Pharmaceuticals and its subsidiary, Pleva, infringed these new so-called 727 and 343 patents and that APP pharmaceuticals infringes the 727 patent based on their applications to market a generic form of Angiomax prior to the expiration of those patents, which is 2028. We have also received a Paragraph 4 certification notice letter from APP Pharmaceuticals related to the 343 patent. We intend to defend our intellectual property vigorously.

Turning to Cleviprex, in the first quarter, we have completed a recall of remaining lots sourced from our manufacturer. The product manufacturing methods did not yield a product meeting our quality standards and until they do, we will not supply the market. We're working with our supplier to remedy this situation as soon as possible, because it's quite clear that there is a rising demand for Cleviprex.

Let me turn to our development portfolio. We have three products under NDA review, or in Phase III, two in earlier stage clinical trials, and we are also generating additional compounds in our research centers in Montreal, Canada, and Leipzig, Germany. We've made progress toward planned initiation of the next Phase III trial for Cangrelor, now back in development.

In prior trials of Cangrelor in ACS and other patients undergoing PCI, published in the New England Journal of Medicine in November last year, the primary endpoint of the 48 are death, myocardial infarction, or ischemia-driven revascularization was not met. However, pre-specified secondary and other endpoints demonstrated superior antiplatelet effects for Cangrelor compared to Clopidogrel, and an ideal intravenous antiplatelet profile including instant onset, rapid reversibility and smooth transition to oral Clopidogrel after PCI.

Critically, the trials also showed clinically and statistically significant reductions in the combined clinical endpoints of death, Q-waves, MI, urgent revascularization and acute stent thrombosis with risk reductions around 45% at 48 hours. Based on these data, we are moving forward with a further Phase III trial. In the first quarter, we completed a protocol, which is called Champion Phoenix, and expect to move forward with the trial this year.

In the meantime, we continue to enroll patients in the 200-patient bridge protocol, which aims to solve the very real and non-infrequent problem of antiplatelet therapy bridging for patients on P2Y-12 inhibitors who require discontinuation of therapy prior to surgery. We plan to include these data in NDA and MAA submissions if the trials are successful.

(inaudible) is the established intravenous drug for treatment of heparin-induced thrombocytopenia and thrombosis syndrome in United States hospitals. The ready to use formulation of (inaudible) that we licensed is under review by the FDA. The development and regulatory filing is handled by our partner according to the license terms, and we have not disclosed the PDUFA date. We do plan for approval sometime this year.

Oritavancin is an injectable antibiotic with potent bactericidal activity against the broad spectrum of gram-positive bacteria including staph strains with resistance to methicillin, so-called MRSA, or mersa, and strains resistant to Vancomycin. The compound’s potential for single dosing to cure MRSA is economically and clinically attractive, and its activity against spores of clostridium difficile, not only the bacteria alone, differentiates Oritavancin from other antibiotics that may be effective in the important condition of C-DIF infection.

In March, we submitted a Phase III protocol for AB SSSI, acute bacterial skin and skin structure infections, to the FDA that complies with the new non-inferiority criteria guided by the agency. The submission was made under the special protocol assessment process, and we can anticipate a type A meeting in the second quarter to discuss fine points of the study, if need be.

We licensed ApoA-I Milano from Pfizer late last year. This is a naturally occurring variant of the Apo lipo protein, AI protein found in human HDL particles that transport cholesterol from tissues to the liver. ApoA-I Milano may be an important agent for rapid regression of atherosclerosis in high risk patients. An initial clinical proof-of-concept study demonstrated that five weekly intravenous injections of recombinant ApoA-I Milano phospholipid complexes significantly reduced plaque volume, giving it the potential to be the first disease-modifying agent for ACS patients.

This quarter, there was a flurry of activity in the sale of HDL Therapeutics. Roche announced a deal with R3 Therapeutics for joint development of ApoA-I Mimetic and Reserve Logics initiated a study with an oral small molecule that induces ApoA-I level elevations. The idea of HDL therapy is therefore very current. In the four months since we licensed ApoA-1 Milano, we have transferred the technical documentation, initiated work with a third party to manufacture drug product for toxicology studies, and logistics for master cell bank transfer in preparation. Biological assays will be transferred next. We are also in the process of preparing for contract manufacturing exchange to manufacture API for larger clinical studies in 2011.

Lastly, the new Healthcare Reform act provides 12 years of market exclusivity for ApoA-1 Milano in the United States.

CU 2010 is a serum protease inhibitor developed by our research center in Leipzig. Its mechanism is similar to Tramodol [ph], as a plasma (inaudible) inhibitor, but it is a small molecule and therefore not expected to have renal toxicity or anaphylactic risk. We have completed the first human safety and kinetic study in normal subjects. Preliminary PK data show linearity with short clearance rates as expected from our animal models. The data also established the product as safe up to the maximum dose tested. We plan to initiate an inpatient study of those undergoing CABG surgery shortly.

There's a real need for this product, as the number of patients undergoing major surgery requiring transfusions has significantly increased since the Tramodol withdrawal. Essentially Leipzig is also discovering and developing additional small molecule serum protease inhibitors and antimicrobial agents. Today we announced that two compounds discovered in 2009 have successfully completed their initial proof of concept studies in animals. We filed new patent applications this quarter to protect these assets.

To wrap up, we made significant progress, growing volume and market share with Angiox and Angiomax in the first quarter. Our acute care pipeline made progress. We accomplished this with a reduction in costs and while tightening up our organizational structures and processes. Among the 2650 hospitals in 25 countries that deliver 80% of the global critical and intensive care, so-called our target market, we today serve approximately 2000 with our operations in 17 countries. We continue to expand our international operations to seek additional sources of revenue.

So now, I'll turn it over to Glenn, who is calling in remotely. I hope you're still there, Glenn.

Glenn Sblendorio

I'm here. Thank you, Clive. Good morning, everyone. This morning, I would like to review some key first quarter financial highlights. First, worldwide net revenue for the quarter was 102.1 million compared to 99.2 million in the first quarter 2009, an increase of 2.9 million or 2.9%.

This was largely driven by strong box sales of Angiomax, averaging approximately 1400 boxes per week in the first quarter. Also, we are seeing accelerating ex-US sales which totaled 5.6 million in the first quarter 2010 compared to 3.2 million in the first quarter of 2009, an increase of $2.4 million, or 75%. Specifically, we are seeing strong growth in Scandinavia, Italy, and Germany.

Clive talked a lot about our R&D portfolio, and we continue to invest in R&D across a diversified portfolio of certain projects. The major initiatives in the first quarter include the ongoing tech transfer of ApoA-I Milano we acquired from Pfizer, continuing Phase I clinical development for CU 2010, preparatory work for the beginning of Phase III trials for Oritavancin and Cangrelor, lifecycle initiatives on Cleviprex and the preclinical work on new compounds in Leipzig and Montreal. We also completed our first quarter cost reduction program through the elimination of 74 US-based positions, which we expect will result in an annual savings ranging from 14.5 to 16.5 million.

In Q1, the net income included approximately 7.1 million in severance and related costs. Q1 net income was 9.4 million, or $0.18 per share compared to a net loss of 3.3 million, or $0.06 a share in the first quarter 2009. Our balance sheet remained strong and we finished the quarter with $184 million in cash, which increased approximately 8.2 million when compared to the end of the year. This, despite the large severance payments I just talked about above.

The company recently began participation in the 340 B drug pricing program, offering qualifying customers, which include disproportionate share hospitals or DSH institutions. Reduced pricing for certain patients undergoing PCI on an outpatient basis.

During the first quarter, approximately 224 accounts purchasing Angiomax purchased at the 340 B price, which is a substantial discount off our WAC price. Outpatient procedures have been increasing, and as Clive said, we believe that number is 15% to 18% of all PCI procedures that are now performed. This percentage is an average for all hospitals, including both DSH and non-DSH hospitals. As we said, this is good for Angiomax and we believe that 340 B pricing to DSH hospitals helped drive additional pricing during the first quarter.

As a result, total Angiomax boxes sold to our distributor during the first quarter was approximately 17,500, which represents our GAAP sales. And approximately 18,200 boxes, were hospital purchases from wholesalers, which as Clive also mentioned, decreased our inventory in the channel.

Consequently, our gross to net increased in the quarter to approximately 15%, primarily related to the offering of 340 B pricing to qualifying hospitals performing outpatient PCIs. Historically, our gross to net has averaged about 8%. We do expect, however, that the gross to net percentage will come down over the remaining three quarters and be in the range of 10 to 12% for the year, as purchasing patterns of our qualifying hospitals align better with actual procedures performed.

I would now like to turn the call back to Clive for summary and questions.

Clive Meanwell

Thanks very much, Glenn. So in summary, Angiomax and Angiox volume and share growth this quarter was significant. It's now global growth and we believe will continue. Our performance in the quarter shows that our operations are doing more with less. We made progress with our portfolio of seven marketed and development products, and we expect solid news flow for the remainder of the year.

With that, I think we could open it up for questions, please.

Question-and-Answer Session

Operator

(Operator Instructions) And your first question comes from the line of Joseph Schwartz of Leerink. Please proceed.

Joseph Schwartz – Leerink

Hi, thanks. Thank you for the explanation on the 340 B Medicare impact of healthcare reform. I'm wondering if you have exposure on the Medicaid side as well, since drugs with significant price increases over their lifecycle seem to have been disproportionately impacted?

Clive Meanwell

I think actually the 340 B we're talking about is not actually an effect of healthcare reform. It's a general rule in place anyway and was there already. It's our decision to move forward in that direction because of the demand, rather than Healthcare Reform Act.

And I think as far as we're concerned, this provides us with a great opportunity to expand the volume of the product in the outpatients, which is a very needy area. And we're going to continue to press that.

As for the Medicaid, I think, Joe, very small proportion of our drug is reimbursed on the Medicaid. It's probably less than 2 or 3%, I think.

Joseph Schwartz – Leerink

All right.

Glenn Sblendorio

Hey Joe, it's Glenn. I just want to reinforce that because people naturally would say this is as a result of healthcare reform. It's our decision to enter the program that has really triggered this increased volume and also as we said, real good for Angiomax. We're seeing uptake in volume as well.

Joseph Schwartz – Leerink

Okay. That's helpful; I understand that's somewhat strategic. How about the next steps with the PTO or the case against the PTO? Obviously this court has decided in favor of you already. You appealed to the same court, it seems. What are the scenarios that could come out of this next decision?

Clive Meanwell

Well, you might understand, Joe, my reluctance to try and estimate the viewpoint of the judge. It is the same judge who we understand who heard the first hearing and who remanded the case back to the PTO. I think at this point, it wouldn't be helpful for me to speculate on which way the court would go. I think we have to respect their process and see what they come out with.

Joseph Schwartz – Leerink

Okay. I'll get back in the queue, then.

Clive Meanwell

Okay, thanks.

Operator

Your next question comes from the line of Cory Kasimov of JPMorgan. Please proceed.

Cory Kasimov – JPMorgan

Hey good morning, guys. Thanks for taking the questions. First one's a follow-up to Joe's last question on this May 6 hearing. I understand that you can't kind of give your expectations for what happens, but in the event that you were successful again with this judge, for the legal neophytes on this call such as myself, what are the – what would the PTO's options be at that point? Can they simply just deny it again, or is this more of a final type of summary judgment?

Clive Meanwell

Well, speaking as a legal neophyte alongside you, Cory, I, I think that the first problem is to hear what the judge has to say, once he has reviewed the case once more and the revised arguments of the parties. I think after that, again, I hate to be evasive, and I don't mean to be evasive, but trying to speculate what the government might do next based upon a judge's decision that I can't predict either would be at least two steps removed from anywhere near my pay grade, so I'm going to defer on that one.

Obviously we do have this – we feel very strongly about this. Obviously we do. We've thought this through very carefully. We feel we have a strong case. We did not file a suit for any other reasons. And we continue to believe that we're doing the right thing for the shareholder and for frankly patients who deserve to get a product that continues to have researched on it, because in our view, the whole issue of us losing 4.5 to 5 years of exclusivity based upon this situation is really a Draconian problem for us.

We do have other opportunities also to shift product exclusivity or regulatory exclusivity or intellectual property rights to a longer period of time and we're going to continue with all of those efforts as well.

So no answer at all, I'm afraid, except to say that it's a tough thing for me to guess, A, what the judge is going to believe, and, B, depending on what the judge decides, how the government will then react. It's tough one for me. I'm sorry.

Cory Kasimov – JPMorgan

Okay, fair enough. On the issue of this two-month IP extension to May 23rd, do you know yet whether or not this will also extend the pediatric period beyond September? Is there two months added to that? Do you have that information yet?

Clive Meanwell

I think that many scholarly legal colleagues are looking at that. I don't think there's a definitive answer at this stage.

Cory Kasimov – JPMorgan

Okay, and then lastly, I'm sure we can back into the number, but can you provide any more clarity on the actual pricing difference between the WAC cost of Angiomax and the 340 B pricing?

Clive Meanwell

Glenn is going to give you that one.

Glenn Sblendorio

Yeah, it’s greater than 50%. It's a very defined calculation that goes really all the way back to the inception of the drug, but the key point is it is in excess of 50%. So, the current vial price is about $650 WAC, and you're going to take a little more than 50% off of that.

Cory Kasimov – JPMorgan

Great. That's helpful. Thanks for taking the questions.

Clive Meanwell

Thanks Cory.

Operator

Your next question comes from the line of Lucy Lu with Citigroup. Please proceed.

Lucy Lu – Citigroup

Great, thank you. First question is on Cleviprex. Just wondering if you can comment on when you think you would resolve the issue, and if you don't for example, second quarter, should we expect any revenue at all?

Clive Meanwell

I think we still believe that we can resupply the market in the second quarter, as we have said before. Again, a lot of work being done behind the scenes to try to improve the manufacturing methodology to meet our quality standards with our partner. I think we'll have to take that one step at a time, because there's great complexity here, Lu. The idea that if we don't re-launch in the second quarter, then we’re not going to get that at all for the year, I think it would be a bit premature. But we'll try to keep you updated as soon as we know anything about the next steps.

Lucy Lu – Citigroup

Okay, and then the second one on Cleviprex, I’m sorry, Cangrelor Phoenix study, if you were to re-start that study, is that going to change? How is that going to change your R&D or the burn rate going forward?

Clive Meanwell

Well, we haven't provided guidance this year, as you know, and it would be a little difficult to do that right now. I think you're very familiar with these kinds of trials and the kind of expense that they represent and usually they are taking a couple of years to do. So I think it would be good to consider the, the Cangrelor trial is likely to be around 10,000 patients and two to three years to complete.

Lucy Lu – Citigroup

Okay.

Glenn Sblendorio

If I can help with that a little bit, Lucy, we when we did provide guidance, expense guidance on the last call, we said R&D for the year would be down, slightly down, or possibly even flat. That did assume that we would have a Cangrelor trial starting in 2010.

So that's not, if that starts up this quarter, next quarter, last quarter, whenever it starts, that was incorporated into the numbers. So we did assume that when we gave that guidance.

Lucy Lu – Citigroup

Okay, thank you.

Operator

And your next question comes from the line of Jason Kantor of RBC Capital Markets. Please proceed.

Jason Kantor – RBC Capital Markets

Great, thanks. So what percentage of your sales are to these DSH hospitals and how should we think about that in terms of, going forward towards the full year number?

Glenn Sblendorio

Jason, it's Glenn. During the first quarter, about 10% of the volume was through these DSH hospitals, were those that were eligible for 340 B pricing. We did see a number of hospitals purchase a significant amount of product under that code, and we're working with them to be sure the numbers are right.

When I read through the text before, I mentioned 15% gross to net in the first quarter going down to 10% to 12% in future quarters. We're working through some procedural things with them. It's the way systems work, the way they purchase, so we've got great relationships with our customers, so we expect that number to come down as we work out the kinks in the pricing program.

So net-net, if you look at our historical gross to net, which was about 8%, we're assuming anywhere from 2% to 4% of additional deductions off the gross to net.

And that 10%, we talked about 224 accounts. I would assume those accounts will continue to buy. And that's about if you take both volume and number of accounts, that's about 10% of our total sales.

Clive Meanwell

And, Glenn, if I'm right, that's a couple of hundred hospitals out of about 12 or 1300 customers we have.

Glenn Sblendorio

That's right. Actually, Jason, the exact number for the quarter, and again, we would assume this number would be similar in future quarters was 224 hospitals that bought under the program.

Jason Kantor – RBC Capital Markets

All right. All right. 224 out of how many, did you say, Clive?

Clive Meanwell

Typically we have about 1200 regular customers in about 1800 total customers.

Jason Kantor – RBC Capital Markets

Okay, and then the wholesaler reduction in inventory, is this a one-time thing? Do you expect them to refill, or is there some reason behind that reduction?

Clive Meanwell

I think that's just part of the quarterly fluctuations we see. We're still within our normal range. We're a little bit at the low end of it at the moment. We've drifted up and down within the range, as you know, Jason. I don't think there was any particular thing, Glenn, was there, this quarter that drove that?

Glenn Sblendorio

No, nothing unusual.

Jason Kantor – RBC Capital Markets

Okay. One last question, if I may. You seem pretty jazzed about Angiox sales and referring to it as an acceleration; I am just wondering, if I look over the last three quarters, it's kind of been, in this 5 and $5.5 million range. So just wondering what you're seeing that we may not be seeing?

Clive Meanwell

Well, this quarter we had almost no sales outside EU. This whole – we're looking at volumes, numbers of boxes and vials being used. And that has doubled from the first quarter last year. So I think when we look at – obviously when we roll up our ex-US sales into a number, what you see it, contains a lot of different things. But what I'm referring to is our ability to tease out the exact number of boxes we're moving and being used in hospitals in Europe.

And that really yes, you're right. I'm jazzed about that. I'm actually jazzed about quite a number of things, as a matter fact, although that's a forward-looking statement.

Jason Kantor – RBC Capital Markets

But the comps you are using is Q1, ‘09, because that was particularly weak. Q4, Q3, Q2 were also double Q1.

Clive Meanwell

All right. Well, I think that they also included non-EU sales, which this quarter didn't. As far as we can see, based on volumes sequentially or year on year, we're seeing very substantial increases.

Jason Kantor – RBC Capital Markets

Great, thanks.

Operator

And there are no further questions. At this time, I would like to turn the call over to Clive Meanwell for closing remarks.

Clive Meanwell

Well, I want to thank everybody for your interest in the company this morning and we will continue to try to keep you informed of the developments. There are many ahead this year and thanks for your attention. Bye-bye.

Operator

Thank you for your participation in today's conference. This concludes the presentation. You may now disconnect. Good day.

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