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The Medicines Company (MDCO)

Q1 2008 Earnings Call Transcript

April 23, 2008 8:30 am ET

Executives

Robyn Brown – VP, IR

Glenn Sblendorio – EVP and CFO

Clive Meanwell – Chairman and CEO

John Kelley – President and COO

Analysts

Liana Moussatos – Pacific Growth Equities

Matt Duffy – Black Diamond Research

Lucy Lu – Citigroup

Joseph Schwartz – Leerink Swann

Biren Amin – Stanford Group

Operator

Good day and welcome to The Medicines Company first quarter 2008 earnings call. My name is Jake Simon and I will be the operator for today's conference. As a reminder, today's call will be recorded. Also, we will have a question and answer session immediately following the prepared remarks.

I will now turn the call over to Ms. Robyn Brown, Vice President of Investor Relations. Please go ahead, ma'am.

Robyn Brown

Thank you Jake and welcome everyone to The Medicines Company first quarter 2008 earnings conference call. I'm Robyn Brown, Vice President of Investor Relations. This morning, I am joined by Glenn Sblendorio, our Executive Vice President and Chief Financial Officer, who will review the first quarter financial results. John Kelley, our President and Chief Operating Officer will provide an operations review. And Clive Meanwell, our Chairman and Chief Executive Officer will moderate a Q&A session at the end of the call.

I would like to remind that you this conference call will contain forward-looking statements which involve a number of risks and uncertainties. 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 the 10-K filed with the SEC on February 29, 2008, which is incorporated herein by reference.

I would also note that during the call, we may refer to non-GAAP measures, which exclude stock-based compensation expense and the noncash provision for income taxes. Please refer to the non-GAAP reconciliation tables in our press release and the 1Q '08 conference call summary fact sheet on our Web site.

Now, I'll turn the call over to Glenn Sblendorio. Glenn?

Glenn Sblendorio

Thank you Robin and good morning everyone. I will start this morning's call with a review of the financial results for the first quarter 2008, and then will turn the call over to John for an operational update. As we reported this morning, total net revenues for the first quarter of 2008 were $79.4 million compared to $66.6 million in the first quarter of 2007, an increase of $12.8 million or 19%.

U.S. Angiomax sales in the first quarter of 2008 were $76.9 million compared to $66.3 million in the first quarter of 2007, an increase of $10.6 million or 16%. International revenues totaled $2.5 million in the first quarter of 2008 compared to $300,000 in the second quarter of 2007. Approximately $1.3 million of the increase relates to our transition agreement with Nycomed, of which end user sales in the ex-Nycomed territories totaled approximately $2.9 million. There were also revenues of $1.2 million from the non-Nycomed territories.

Cost of revenue was 24% for the first quarter of 2008 compared to 27% for the first quarter of 2007. The change in cost of revenues is driven by the increase in revenue from our transition agreement with Nycomed and $1.4 million in credits due from our U.S. wholesalers in connection with our price increase announced in January 2008. The $1.4 million credit decreased our gross to net adjustment to 5% for the quarter.

Inventory at the wholesalers continues to remain within our targeted range of approximately four to six weeks. R&D spending was $18.7 million for the first quarter of 2008 continue to $19.5 million during the first quarter of 2007. The as-expected 4% decrease in R&D primarily related to decreased expenditures in connection with Angiomax and Cleviprex, offset by an increase in the ongoing Cangrelor clinical trial development program.

R&D investment in our pipeline products, Cangrelor and Cleviprex accounted for 74% of the total R&D spend, which reflects the continued shift in our R&D investments to our pipeline products. We also continue to increase our business development expenses in connection with our efforts to evaluate and acquire product opportunities that could expand our product portfolio. These costs are included in R&D.

SG&A spend for the first quarter of 2008 increased approximately 30% to $35.4 million for the first quarter of 2008 from $27.1 million for the same period in 2007. The increase in selling, general and administrative expenses of $8.2 million was primarily due to an increase in Cleviprex expenses of $3 million in preparation for the anticipated launch of the product and $3 million in costs associated with our European expansion. The remaining increase is due to stock-based compensation expense and other headcount related costs.

Total stock-based compensation expense was $4.6 million in the first quarter of 2008 compared to $3.5 million in the first quarter of 2007. Stock compensation expenses included in cost of revenue, R&D and SG&A at 3%, 15%, and 82% respectively in the first quarter.

Interest income for the first quarter of 2008 was $2.4 million compared to $2.6 million in the first quarter of 2007. The decrease in other income of approximately $0.2 million was primarily due to lower rates of return on our cash and available assets securities. The provision for income tax was $3.9 million based on pretax income of $8.7 million in the first quarter of 2008 as compared to $1.8 million provision for the first quarter of 2007. This resulted in an effective tax rate of 44% in the first quarter of 2008 and 37% in the first quarter of 2007. Of the $3.9 million income tax provision, $900,000 was cash and $3 million was noncash as we utilized our NOLs.

Now, to move on to GAAP and non-GAAP net income and earnings per share. For the first quarter of 2008, we reported GAAP net income of $4.9 million or $0.09 per share as compared to $3 million or $0.06 per share in the first quarter of 2007. If we remove stock-based compensation and noncash tax provision, non-GAAP net income for the first quarter of 2008 was $12.4 million or $0.24 per fully diluted share compared to non-GAAP net income in the first quarter of 2007 of $8.2 million or $0.15 per share.

I'd now like to turn the call over to John for the operational update.

John Kelley

Thanks Glenn and good morning everyone. Thanks for joining the call this morning. I'll start my comments this morning focusing on the sales of Angiomax. In Q1 of 2008, over 13,000 boxes were shipped to hospitals.

As we discussed in our last conference call, we had a strong buy-in at the hospital level in December of 2007. We estimated that 2300 to 2600 boxes in excess of demand were purchased by some of our larger hospitals, which impacted purchases at the hospital level in Q1.

Demand in Q1 was down 10% from Q1 of last year and off 20% from Q4. We anticipate the gross sales for the quarter will be reported by third party audits at approximately $74 million, an 8% increase over Q1 of 2007. Boxes sold to our distributors in Q1 were over 14,000. The boxes sold above demand represent restocking early in Q1 by distributors after inventory levels were depleted in December based on the strong hospital purchases. Our inventory levels in the pipeline remain in the four to six week range that we have targeted.

Angiomax continues to increase market share in this difficult market. Overall share for all patients undergoing PCI was at 42% in the three months ending January of 2008, up from 39% for the same time last year.

In the stable angina patients, the shares climbed to 57% up from 52%. Unstable angina share is now at 49%, up from 44%. Non-STEMI shares 34%, up from 32%, and STEMI is at 20%, up from 18%. We have limited data on PCI patient volumes in Q1 with only January data available to us so far. Volumes are off by 4% in January of 2008 versus 2007. We would anticipate that the volume for Q1 will also be off over last year of Q1 since we did not see the impact from the courage [ph] trial until Q2 of 2007. However, we do believe that volume decline has stabilized and volume for Q1 of 2008 should be in the range of Q4 of 2007.

A major focus of The Medicines Company in 2008 is increasing patient share, especially in the higher risk patient population. We believe data from the HORIZONS AMI trial established the benefit of Angiomax in the highest risk patients, those undergoing primary PCI in STEMI.

At the recent ACC meeting in March, additional data from the HORIZONS AMI trial was reported and showed that Angiomax resulted in improved net adverse clinical outcomes and reduced the risk of major bleeding despite the sex, age, diabetes status or renal function of heart attack patients compared to a more complex treatment regimen 30 days following primary angioplasty. These new findings are consistent with overall results from the HORIZONS AMI trial that demonstrate treatment with Angiomax resulted in superior net clinical outcomes and fewer cardiac deaths when compared to unfractionated heparin plus the glycoprotein inhibitor in patients presenting with FT segment elevation myocardial infarction, the most severe form of heart attack.

Reduced bleeding has been associated with greater long term survival and other studies in angioplasty patients. We believe this important data will encourage physicians to treat STEMI patients with Angiomax in addition to driving increased use of Angiomax across all spectrums of patients undergoing PCI.

At the request of the FDA, we have submitted data from the HORIZONS AMI trial to the agency to include in the review of the sNDA for the ACS indication. As reported previously, we have already been granted an approval of the ACS indication for our European label.

In Q1, significant work was done to establish The Medicines Company outside of the United States. A number of meetings with key opinion leaders in Europe were held including an expert health economist panel and separate meetings with physicians in Germany, France, Italy and the UK, as well as a recent meeting with opinion leaders from across Europe.

These meetings have served as an opportunity for us to establish our relationship with key opinion leaders, to introduce The Medicines Company to them and to explain our vision as a company focused on hospital care products, to explain our pipeline, and to present the data on Angiox. We believe that we have been favorably received in these meetings and we have established relationships with opinion leaders that will allow to us build our business. We still have a lot of work in front of us, but we feel that feedback from our meetings indicate a willingness to use Angiox, especially in high risk patients and those patients at risk for bleeding. We also believe that we are laying the foundation for the introduction of all of our products in the EU.

Now, turning to Cleviprex, the NDA review has been progressing at the FDA. We've had active discussions with FDA on the review including labeling discussions. We are continuing with our prelaunch activities and preparing for the launch of the product this year.

As we said in our last call, our goal for 2008 is to launch the product and to generate $5 million to $10 million in sales in 2008. Our Phase III program on Cangrelor continues to move forward and we believe we are still on track for the first half 2009 submission of the NDA. We have been continuing to expand our reach with both trials, with CHAMPION PCI being conducted in 12 countries with 196 sites activated.

CHAMPION platform is now enrolling in 14 countries with 155 sites activated. In the next few months, we anticipate expanding to several new countries in the regions. To date, we have over 5800 patients enrolled in CHAMPION PCI and over 2300 enrolled in CHAMPION platform.

In summary, we had a strong quarter in top line sales for Angiomax and we are making progress in building our organization outside of the United States. We are also making significant progress in moving our pipeline products towards commercial launch.

Now, I'll turn the call over to Clive.

Clive Meanwell

Thank you very much, John. 2008 has got off to an encouraging start at The Medicines Company with sales growth driven by our base Angiomax business in the U.S. We would expect this growth comprised of market share gains, improved value delivery to patients and increased volume to continue based on results in the recent trials and (inaudible).

We also of course have other sources of growth including expansion in Europe, the launch of Cleviprex, Cangrelor, which is another near-term opportunity. And in addition, we have potential opportunity to expand our portfolio of high-value growth through business development.

So, the firm is set up with experienced and capable management and the financial result is to continue to build and grow. And we are looking forward to a successful year in 2008 based upon this first quarter foundation.

And now, we are ready, Jake, to take some questions.

Question-and-Answer Session

Operator

(Operator instructions) And we will take the first question from Liana Moussatos with Pacific Growth.

Liana Moussatos – Pacific Growth

Thank you and congratulations on a great quarter. Could you just review again the breakdown of the stock-based compensation, you mentioned 3%, 15%, 82%, and then review again, say, the enrollment in the Cangrelor trial for where it is?

Glenn Sblendorio

Sure, Liana. It is cost of revenue 3%, R&D 15%, and SG&A 82%.

John Kelley

And in the Cangrelor trials, Liana, the CHAMPION PCI trial, we are over 5800 and CHAMPION platform over 2300.

Liana Moussatos – Pacific Growth

Great. Thank you very much and congratulations.

John Kelley

Thanks.

Operator

And now we will take a question from Matt Duffy, BDR Research.

Matt Duffy – Black Diamond Research

Good morning. Nice quarter and thanks for taking my question. John, I wonder if you could run through again very quickly the, I guess not quite so quickly the market shares you went through? I can't listen that fast (inaudible) write that fast. I'd appreciate it.

John Kelley

Well, that's the point, Matt. No, I'm just kidding. All right, so we'll do this again. So, market share overall for PCI so total patients undergoing PCI 42% in the three months ending January of 2008, and that's up from 39% same time last year. Stable angina 57%, up from 52%. Unstable angina 49%, up from 44%. Non-STEMI 34%, up from 32%. STEMI 20%, up from 18%.

Matt Duffy – Black Diamond Research

Okay, great. And are your reps out there fully loaded or how long this kind of will take them to get fully loaded with all the new data and being able to promote really everything that you guys are after with the clinical data that's been at least presented but maybe not all the way through the FDA?

John Kelley

Our reps are out there promoting the products within its -- current indications, which includes up to and including HORIZONS and PCI patients.

Matt Duffy – Black Diamond Research

Okay, great. And then, lastly the European front, can you just talk about what's going on over there, what steps you are taking in terms of getting ready to start driving sales over there as well?

John Kelley

Sure. Well, I think the first thing that we felt we needed to do was to introduce The Medicines Company to key opinion leaders and to help them understand what it is we are trying to accomplish and to present the data to them that we have and to get their feedback on where they see the product fitting in. We thought most appropriately we need to start by understanding what the economic situation for the product would be in Europe, so we did a Health Econ Panel in January with a number of key opinion leaders that helped us I think understand and to look at what types of work we would do to demonstrate the value proposition for Angiox. We have followed that up with key opinion leader meetings in each of the four key countries.

So, we've done one in Germany, France, Italy, and UK. I think there we had a chance to meet with these physicians to again explain what the company is trying to do. The fact that we are coming to Europe not just with Angiox but we have two other products that we intend to introduce into the marketplace and to build -- try to build a relationship with them, that we are coming to stay and not just here with one product. So, I think that that's been very well received. It's also given us a pretty good opportunity to really just go through the data with them, which honestly the sense is that they were aware of the data, but don't really understand the data, some things like HORIZONS and ACUITY and elsewhere.

So, we have been able to have a very good dialog on that, get feedback from them. And I think universally, the feedback we have gotten is products have been under-used. They probably haven't known as much about the products as they should and that they see that this is a product that has a place in their practice particularly in high risk patients and patients at risk for bleeding. So, with that feedback, I think we've got some pretty good ideas now in terms of additional trials that we might want to look at, some registries, some health economic type evaluations and a platform from which I think we can continue to build a relationship and to promote the product.

Matt Duffy – Black Diamond Research

And how long does it take before using that information before you can start to actually start generating additional sales?

John Kelley

Well, I think we said that this year we don't expect to see much in the way of an impact because it does take some time. But, I would hope that we are in a position by the end of this year that we are in -- starting to get pretty good traction to see impact in 2009.

Matt Duffy – Black Diamond Research

Okay, great, thanks.

John Kelley

You are welcome.

Operator

Now we'll take a question from (inaudible) with Citi. Ma'am or sir, your line is open.

Lucy Lu – Citigroup

Sorry, actually Lucy Lu, thank you. The question is since you filed HORIZON AMI data with FDA, when they act on your sNDA in June or second quarter, is it possible they would incorporate HORIZON data into (inaudible) or can you get both ACS and AMI for the new indications? Thanks.

Clive Meanwell

Thank you, this is Clive Meanwell here. I think it was very important that we added the information to the FDA's -- the information that's sitting on their desk. It's early for to us comment on whether or not the ideas that you are expressing would make sense for them, and we haven't yet had that conversation with them, but obviously the intention of providing these very, very important data to them which do show a mortality benefit of further 30 days do show a dramatic reduction in bleeding in the very highest risk patients with no giveback at all on ischemic complications. I think it's obviously anticipated to be influential only if I'm just thinking including the scientists of the FDA. So, we obviously submitted it with purposeful intent and we believe they'll read it with purposeful intent.

Lucy Lu – Citigroup

Great. And then, can you please give an update on sales force expansion and also how in terms of sales and marketing resources how they're going to be allocated to Angiomax with the new indication versus Cleviprex? Thank you.

Clive Meanwell

John, I think that's probably one for you.

John Kelley

Yes, sure. Right now, we have added the additional management team necessary for our sales force expansion and we have been recruiting and interviewing sales rep candidates but have not yet put any new sales reps into place. So, we still currently are at 123 sales representatives. As we said on the previous call, we plan to expand to 178. And the way that the territories are being constructed is really based on what potential we believe the product has for Angiomax as well as Cleviprex in key institutions. So, each sales representative will be calling on approximately six to eight institutions and they will split their time between Angiomax and Cleviprex really based on what we think the opportunity is on a hospital by hospital basis.

Lucy Lu – Citigroup

Okay, thank you.

Operator

Now moving on to a question from Joseph Schwartz with Leerink Swann.

Joseph Schwartz – Leerink Swann

Thanks for taking my question. I'm sorry if you already touched on this as I got on the call a few minutes late. But, I was wondering if you are sensing any rebound in any coagulation usage overall due to new product launches on the stent side? Thanks.

Clive Meanwell

Hi, Joe, this is Clive Meanwell. We've obviously been listening to what the stent companies have said recently quite carefully and we are encouraged by their encouraging viewpoints. I suspect they have slightly better data sources for stent sales than we do or I'm sorry expect they do. And so, we are kind of following that with interest. I wouldn't say right now we have substantially better news from anticoagulant monitoring. We think the word stabilization makes sense in terms of the low risk patients. But I don't think we have yet seen anything that could be construed as growth within the stable angina market for angioplasty, which obviously is about 50% of the patients. Obviously, the high risk patients have always been in demand and they continue to be so. With the new data we have in high risk patients, I think that's the place for to us focus our attention and energies at a time when the rest of the market is heavily penetrated by Angiomax already and not showing – in terms of market share, and not showing great signs of growth but is showing signs of stabilization.

Joseph Schwartz – Leerink Swann

Okay. And then, in terms of then your own activities, as far as new accounts go, are you noticing that hospitals that have not historically used that much Angiomax are approaching you now or seeming more receptive with all the data that you have in hand, and are you changing your sales force districting in any way with the added feet on the street?

John Kelley

Joe, this is John. Yes, I think that we continue to see where we make progress with accounts. We have I think over the last couple of years had very good success in penetrating those accounts that we previously had not, so we feel very comfortable with the penetration. But, there's always some accounts out there where we continue to look to do better and we see progress there both based on the data that we have and as well as I think we have a very compelling economic argument that we can make for the use of the product. So that continues to help. We will redistrict the sales territories once we go through the expansion. We've already mapped that out and explained that to folks. And once we start to bring new reps on, we will implement that.

Joseph Schwartz – Leerink Swann

Great, thanks so much. I'll get back in the queue.

Operator

Now Biren Amin with Stanford Group has the next question.

Biren Amin – Stanford Group

Yes, hi, thanks for taking my questions. I guess the first question would probably go to Glenn. I noticed on the balance sheet the cash decreased by about $6 million. Could you maybe just give us some reasons for this?

Glenn Sblendorio

Sure. The major item that was paid was a cash item in the first quarter was $15 million to Nycomed. If you remember, we announced the Nycomed transaction, there were three payments, one upon closing, one in the first quarter which was January, and one that will occur when we finish the transition with them at the end of June. So, that was the major impact on cash. The other is that you do have the year end expenses such as year end bonuses that are, I won't call them one-time, but they are also paid. So, those two items account for the difference in cash.

Biren Amin – Stanford Group

Okay. And I think you also mentioned on the call that there were over 14,000 boxes sold to distributors. So, could you comment on the number of Angiomax boxes bought by hospitals from distributors?

John Kelley

Yes, the boxes out to hospitals, Biren, were about a little over 13,000. We don't have all of the audit data yet, but we believe it's over 13,000. So there's a difference there of somewhere in the range of about 1,000 boxes in that range. And again, that's a reflection, I think, of the distributor restocking after their inventory ran down in December when there was very strong purchases in connection with the price increase we took.

Glenn Sblendorio

Biren, just to give you the other side of that, in December, our sales to hospitals were -- or the sale from the wholesalers to hospitals was 1,000 boxes higher. You really need to look at this quarter to quarter so the 1000 kind of washed out.

Biren Amin – Stanford Group

Okay, got it. And lastly, I guess, could you comment on the Angiomax pipeline, I believe most are aware of the activities in Congress, but could you maybe comment on the company's plan B in case efforts fall short there? And secondly, has the company heard of any potential ANDA filings for Angiomax at the FDA level?

Clive Meanwell

Hi there, it's Clive here. With regard to the patent, just to sort of give you a more complete answer, as most people know, legislation has been introduced in both houses of Congress that with (inaudible) discretion to consider late filings under Hatch Waxman, and passage of that legislation were to occur, it would almost certainly give us the opportunity to restore the Angiomax patent from patent term to 2014 from its currently expected run out date of late 2010, including what we would anticipate to be in terms of pediatric extension.

Now, the status of the patent format discussions before the Senate, which obviously contains that granted discretion has been widely reported in the press and in media. There is a good deal of speculation about where it stands. As far as we can tell, the debate is continuing. And similar legislation has, of course, already passed the House of Representatives. And so, I think we remain quite focused on advocating for changes in the patent law in both chambers that would solve our problem, not only because we believe it's good patent policy but we also think it's good innovation and health policy.

With specific regard to Angiomax, this is all the more the case at a time when there are serious questions about the worldwide heparin supply and issues around that. So, we think it's a very strong point of focus. You mentioned the concept of plan B and quite honestly, we don't see it that way. We see that we are advocates for change and it is really up to the legislatures how they want to go about things. We don't control Congress. We merely advocate for things that we think are important and that's what we are doing. And as to whether it's plan A or plan B, it would be a bit impossible to describe in those terms. What we will reiterate is as far as we can tell, there's still a great deal of debate about the main patent reform act in which sections (inaudible) would solve our problems. As things develop, we'll obviously continue to advocate for that change. In terms of ANDA filing, we don't comment on that kind of thing and we never have and we probably never will.

Biren Amin – Stanford Group

All right, great. Thanks for answering my questions.

Clive Meanwell

You're welcome.

Operator

And we will take one final question that will be a follow-up from Liana Moussatos, Pacific Growth.

Liana Moussatos – Pacific Growth

You attribute the strong Q1 sales partially due to the tainted heparin that's been announced – that's been in the news?

John Kelley

Liana, this is John. No, I don't think so. As we have looked for feedback from physicians working in the cath lab, that -- quite honestly that scare really hasn't translated into that level of use. A couple of hospitals, yes, where I think we are aware of a few that have tried to go heparin free and to move all of their patients away from heparin to other products. But, in general, I think they are still focused on making sure that they have heparin supplies available, they seem to have been able to do that. And as you know, heparin is used so widely across the hospitals for so many different indications, the cath lab being just a piece of it. I think their primary concern is in making sure that they have heparin available. But, we would not yet say anything in terms of it having an impact on our sales one way or the other.

Clive Meanwell

And Liana, I want to add a couple of things. First of all, what's happened with the supply is obviously a dramatic human tragedy with about 100 people potentially having died over this. As people who provide this marketplace, the absolutely last thing we would want to do is go out and promote products on the back of that amazingly problematic situation. So, our goal is to support our physicians in what they are doing, make sure they understand that Angiomax has certain attributes approved by the FDA and certain quality which in the cath lab has proven time and time again to be the best product even with non-tainted heparin as the comparator in our clinical trials. So, we are going to continue to do that, but we're certainly not going to try to take advantage of what is a human tragedy in the United States around heparin. And so, that's kind of how we looked at it. And so, even if there was an uptick, it would not be one that we would be especially proud of or feel that it's something we had driven.

Liana Moussatos – Pacific Growth

All right, thank you very much.

Operator

That will conclude your question and answer session. I will turn the call back over to your host for closing remarks.

Clive Meanwell

Well, thank you very much for taking an interest in The Medicines Company today. We're enjoying ourselves this first quarter and now already fully into the second quarter and look forward to updating you in our progress in the future. Thanks very much indeed.

Operator

And that does conclude your conference for today. Thank you for your participation. Everyone have a wonderful day.

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