Flamel Technologies' CEO Discusses Q1 2012 Results - Earnings Call Transcript

May. 7.12 | About: Flamel Technologies (FLML)

Flamel Technologies SA (NASDAQ:FLML)

Q1 2012 Earnings Call

May 7, 2012 8:30 am ET

Executives

Michael Anderson – Chief Executive Officer

Sian Crouzet – Principal Financial Officer

Analysts

Matt Kaplan – Ladenburg Thalmann

Peter Butler – Glen Hill Investments

Russell Cleveland – RENN Capital

Roger Bensen – Number One Corp

Operator

Good morning ladies and gentlemen and welcome to the Flamel Technologies First Quarter 2012 Results conference call. Today’s call is being recorded. At this time, I would like to turn the call over to Michael Anderson, Chief Executive Officer of Flamel Technologies. Please go ahead, sir.

Michael Anderson

Thank you and good morning ladies and gentlemen. We want to open as always with the forward-looking statement language that’s set out at the conclusion of this morning’s press release. All statements made on this call about future events, results, performance, products under development, plans or objectives are forward-looking. Actual results may differ materially from these statements due to risks and uncertainties over which we have no control. We encourage our shareholders to review the risk and other disclosures set forth in our SEC filings, which are all of course publicly available.

This is my first call as the CEO of Flamel, and despite the very short of period of time since I’ve been on board, I’ve already been impressed with both our best-in-class drug delivery technology and the high quality of our Company’s employees. Rest assured that as the CEO, my constant focus will be to build long-term value for shareholders.

I also share the desire of all of our shareholders, that being to improve Flamel’s share price so that it better reflects the true value of the Company. As a result of our historical model, primarily collaborating with other pharma companies on their proprietary molecules, we’ve been unable in the past to disclose a number of these collaborations. While this will remain the case for the foreseeable future, it continues to make it challenging for investors to fully appreciate Flamel and to count on a steady stream of catalysts to drive the share price appreciation. The ultimate solution to this problem in my view is to perform by enjoying greater commercial freedom and therefore financial success. One of the best ways to do this is to add a number of internally controlled high value products to our pipeline.

I would like to make it very clear that I’m not talking about becoming a high burn, high risk biotech company; rather, we’re looking for targeted niche opportunities where we can develop products and market them in a highly efficient manner and at low cost. In the end, I hope to integrate a vibrant specialty business on top of Flamel’s high value collaboration portfolio. Our ability to commercialize these opportunities ourselves is what the acquisition of Eclat Pharmaceuticals is all about.

As we discussed the acquisition in detail on our last call, I’m not going to go into a lot of detail on the transaction itself, but I do want to highlight some of the key benefits. The acquisition brought Flamel one approved product already on the market, Hycet, as well as a portfolio of products that are in various stages of R&D completion. This pipeline of products, when combined with Flamel’s best-in-class drug delivery platforms has created a more vertically integrated pharmaceutical company with greater upside potential, greater control of our pipeline, and dramatic new opportunities for growth.

Our product portfolio now includes multiple high value opportunities for near-term cash flows that carry a more balanced risk profile. We plan to employ the near-term cash flows to fund the development of the products using our drug delivery platforms as we believe the opportunities are numerous and significant.

As I said during our last call, the competitive nature of our business does not allow us to identify the specific products with which we are working at the present time. In addition to Hycet or hydrocodone acetaminophen oral solution, we have a number of products under development. We remain on track to file at least one NDA this year, meaning an approval could come as early as next year. We’re hopeful of being able to discuss individual NDAs as they are filed. Most important, however, is that we do not compromise our competitive position by sharing too much too soon. We’ll also continue to pursue partnering opportunities as we have in the past.

Since the completion of the acquisition, we have been working hard on integration, including a company-wide portfolio review and management transition. We have now completed the review of our entire project portfolio and have identified a number of additional shorter term high value opportunities, but we’re not going to be able to comment a great deal on those today. Part of that pipeline review has allowed us to identify a number of areas where we can better utilize our resources to create shorter development cycles and therefore less risk. We do expect to provide investors with additional visibility in upcoming conference calls and presentations.

I would now like to ask Sian Crouzet to please provide an overview of our recently announced financial results.

Sian Crouzet

Thank you, Mike, and good morning. The financial results for the first quarter of 2012 continued to reflect the incremental benefit of the new supply agreement signed with GSK on September 30, 2011, partially offsetting the continuing challenging environment in which we are working with respect to our license and research revenue streams. Total revenues during the fourth quarter were $7.3 million compared to 6.8 million in the year-ago quarter, an increase of 8.4%. Product sales increased by 1.7 million year-over-year while license and research revenue decreased by 1.1 million over the same period.

Cost and expenses for the first quarter of 2012 were $12.1 million compared to 11.7 million in the prior year period. R&D expenses decreased from 7.8 million in the first quarter of 2011 to 5.7 million in the first quarter of 2012. This is primarily as a result of timing year-over-year of both clinical and preclinical programs. Our SG&A cost for the first quarter increased from $2.5 million in the first quarter of 2011 to 5.1 million in the first quarter of 2012. Included in the SG&A is $0.7 million of cost associated with the Eclat acquisition and severance costs of $1.4 million.

For the first quarter, our net loss was $4.7 million or $0.19 per share, as opposed to $4.9 million or $0.20 per share in 2011. With respect to cash and marketable securities, we finished the quarter in a strong position with $21.3 million of funds. Please note that these financial results are not consolidated to include the activity of Eclat Pharmaceuticals for the period of March 13 date of acquisition to March 31, 2012.

I will now turn the call back over to Mike.

Michael Anderson

Thank you, Sian. As I stated earlier, we expect to provide investors with additional visibility hopefully in the near future. In the meantime, I want to assure investors that Flamel will remain focused on building a sustainable vertically-integrated specialty pharma company, one that’s anchored with what we believe are world-class drug delivery technologies and ultimately delivering shareholder value. Our singular goal here is to create that value by performing consistently and by achieving commercial success with our various technology platforms.

So with that, Operator, at this point we’d be pleased to open up the call for any questions.

Question and Answer Session

Operator

Thank you. If you would like to ask a question, please signal by pressing the star key followed by the digit one on your telephone keypad. If you are joining us on a speakerphone, please make sure your mute function is turned off to allow your signal to reach our equipment. Also, if you have pressed star, one earlier in today’s conference, please press star, one again to ensure our equipment has captured your signal.

First we’ll hear from Matt Kaplan with Ladenburg Thalmann.

Matt Kaplan – Ladenburg Thalmann

Hi, good morning Mike. Can you hear me?

Michael Anderson

Yes, I can. How are you this morning, Matt?

Matt Kaplan – Ladenburg Thalmann

Doing well, thank you. How about yourself?

Michael Anderson

Good. Just fine, thank you.

Matt Kaplan – Ladenburg Thalmann

Good. A few quick questions – first, starting off with let’s call it the acquired Eclat pipeline. I understand you can’t give us detail in terms of what the products are for competitive reasons, but can you give us a better sense when you say near-term cash flows when you could be filing your first NDA – you say in 2012. Could you give us a little bit more clarity in terms of when in 2012?

Michael Anderson

Yeah, great question, Matt. First of all, we are very far down the pathway with our first NDA, and we’re hopeful of filing that and expecting to do so sometime well before the end of the year as it exists today. So if you look at that as a potential filing date, then it is certainly conceivable and our expectation that we would see revenue from at least that first NDA maybe even in 2013. We actually are working and have moved a number of those projects along, some of them—none of them quite as far as our first one, but we’re making great progress and would expect to see revenues from that sometime before the end of 2013.

Matt Kaplan – Ladenburg Thalmann

And when you said in your prepared remarks at least one NDA, is it possible that you could have two filed in 2012?

Michael Anderson

Listen, I mean, we have a number of them, as you know, under development and certainly that’s a possibility. At this point in time, our expectation for certain is that we’ll have one, and to the best that we can do with the others, we’ll clearly move them along as best we can.

Matt Kaplan – Ladenburg Thalmann

Great. And then just some questions with respect to some of the partnered programs that Flamel had existing before you joined. Can you give us an update in terms of, I guess, an unpartnered program – an update on the two interferon programs, the alpha-interferon and the beta-interferon, and then with Merck Serono? And then also, the pain management or Trigger Lock partnered programs and the status of those?

Michael Anderson

Yeah, I’d be glad to. First of all, and of course with the Merck Serono deal, we really don’t have as much of an update as people would like to hear. As you know, the Phase I clinical studies were completed. They’re currently being studied by Merck Serono. We’ve had and continue to have active discussions with them about those. More recently, as you are also aware, Merck Serono has had some issues within their own organization which have kind of changed their focus a little bit over the last several weeks, so those discussions are ongoing. As soon as we have something that we can announce, clearly we’ll obviously do that.

As it relates to interferon-alpha, as you know, we’ve had one article that was—or a poster session that was published back in the fall. We also have another one scheduled to be presented in June – June 12 in Shanghai at the International Symposium for Viral Hepatitis and Liver Disease. It’s going to be held closer to the end of June in Shanghai, a paper that’s presented on that; and in the early going, clearly we’ve shown the product is very safe, for the most part minimizes side effects, and is at least equivalent to peg-interferon. So we’ve made good progress with the program, we currently have discussions ongoing with potential partners, and as those discussions become further down the track, we’ll be glad to talk about them. Until the deal is a deal, it’s not a deal, of course, and so it would be premature to discuss anything along that line at this point.

So those were your first two. I think your next one was the Trigger Lock. We do have some—a couple of partnerships for investigation Trigger Lock and its capabilities. As you know, one of the deputy directors of FDA last week described the FDA’s plans to establish full guidelines for what’s an acceptable abuse-resistant technology by the end of the year. We have every expectation that our delivery system, Trigger Lock, will meet whatever specifications they may set, so we have projects in development and we’re continuing to move those forward.

So hopefully I’ve been answered or been somewhat responsive to your questions.

Matt Kaplan – Ladenburg Thalmann

Yes, absolutely. And maybe just a follow-upon Trigger Lock and then one more question and I’ll jump back into the queue. Can you give us a sense in terms of the status, in terms of what state they are in development? Are they in the clinic, past Phase I, in Phase III? Can you give us a sense?

Michael Anderson

Well Matt, unfortunately we really haven’t talked about that in the public. They are not brand-new agreements, so they are moving forward and that’s about probably the best I can say about them today. Again, this is a very interesting area, as you know. There have been a number of companies who are attempting a number of different approaches to create abuse-resistant projects. You see products combined with narcotic antagonists and with niacin to do flushing. We think we have a pretty robust system and hopefully we’ll have something in the not-too-distant future to talk about there.

Matt Kaplan – Ladenburg Thalmann

Great. And then final question in terms of—you ended the quarter with 21 million-some-odd in cash. Can you give us a sense in terms of what you anticipate the burn rate to be going forward as you integrate the new strategy for Flamel?

Michael Anderson

Right. Well, I’ll let Sian address that and then I can add something if we don’t complete it.

Sian Crouzet

Okay. Well as you know, we’re not accustomed to providing guidance and don’t expect to change that policy going forward. All I’d really like to say is that at this time, we don’t know—there’s nothing to suggest that our cash burn will be significantly different from what it’s been in the past.

Michael Kaplan

Okay, fair enough. Thanks Sian. Great, thanks guys.

Michael Anderson

You’re welcome. Thank you, Matt.

Operator

We’ll take our next question from Peter Butler with Glen Hill Investments.

Peter Butler – Glen Hill Investments

Good morning, good morning. In the pharmaceutical business, isn’t there a rule of thumb on what a potential product might be worth? For instance, I’m speaking specifically about the alpha-interferon. This product, potential product has successfully passed Phase II trials and it’s a better version of an existing drug that has sales over a billion. Now, isn’t there a rule of thumb that says what this product might be worth?

Michael Anderson

Well, listen – that’s a great question. You know, in this business for many, many years, every company that I’ve ever known or been associated with has an extensive process by which it creates NPVs for projects that it’s developing, which is a combination of looking at what it costs you to develop it, existing marketplace, along with the amount of money that it’s going to take you to get it to the promised land, so to speak; and that’s no different with interferon-alpha. The marketplace today is quite large. Our product, we are hopeful, will ultimately show to be safer and at least as efficacious, if not more efficacious from an antiviral perspective than other projects that are on the market. But part of that has to be measured by when you expect to have the product into the marketplace. Alpha-interferon, combining that with Medusa technology is not an easy process to go through, and the result of all that means that in many cases, you have to make sure and do additional studies to make sure that the combination of the interferon along with your delivery system doesn’t do something that no one expects it will do.

Our ultimate objective here is to provide cost-effective therapy. If you look at the hepatitis market, you find that a lot of it is either in the Pacific Rim, Southeast Asia, eastern Europe and countries really other than the U.S., and so there exists as far as we’re concerned a really good opportunity for this. But it is important, Peter, frankly, that we move this project and some of the other ones forward as quickly as we can because the scope of these disease states changes over time, and what may be good today and tomorrow and next year for a therapy may not be as applicable five or six years from now. So we have that in mind, and we’re interested in doing things here that are commercially oriented, that are designed to get our drug delivery systems commercialized, and even though we’d always like for it to be in the best places or places we design, at this point in time we’re looking and we need to have these things be successful, no matter where they may be.

So I didn’t answer your question – I recognize that. But the answer is that yes, there is a way to model these things. We do do that, and we expect still that interferon-alpha has a role in therapy.

Peter Butler – Glen Hill Investments

Mm-hmm. Well, there’s got to be a rule of thumb in this business that if you assume certain parameters, that the drug is worth X-million, et cetera—I don’t know.

Michael Anderson

That’s correct. We do look at that, and you also have to gauge it by what market it’s going into and the size and the circumstances that surround the drug in that market. For example, you wouldn’t expect to get the same kind of return if you were licensing the project to a company in India for that territory as you would for other areas. So clearly, you’re exactly right – there is a model and you can do that, and we do do that.

Peter Butler – Glen Hill Investments

Okay. I previously—I thought I understood that Flamel was going to have a partnered project go commercial in 2012. I thought it was some version of your Micropump Trigger Lock technology. Was I just—misunderstood this, or is in fact a Trigger Lock product pretty close?

Michael Anderson

Well, I’m not aware of a Trigger Lock product that’s that close, and not having been here all that long, I can’t really address products that were identified as being approvable in a certain year. I can tell you I think pretty reasonably that there’s no reason to anticipate that we’re going to have a Trigger Lock approved in 2012. We do have an older partnership that’s been talked about, New Haven Pharmaceuticals, with an extended release protected Micropump-driven aspirin – ASA – that’s still alive and moving forward, but that’s the only one that I know that really would be short-term as you’ve described it, and that doesn’t have Trigger Lock, so.

Peter Butler – Glen Hill Investments

Okay. Well as you know, investors when they invest like to dream about where a company could be going and what sort of rewards they might be getting. I’m wondering, could you help these dreamers with what you expect Flamel to look like a year from now in terms of possibly earning some money, positive cash flow, increasing the cash on the balance sheet, et cetera? Is there blue sky ahead?

Michael Anderson

Well, even though it’s forward-looking, I always like to think there’s blue sky, and I’m here because I believe there is blue sky ahead. I think that in the six weeks or so that I’ve been here, I’ve been impressed—first of all, when I came here, I believed the drug delivery technology – and I’ve been in the drug delivery business for a number of years with companies who’ve had it, who have even licensed it. And so I don’t pretend to be a scientist but I do believe this is very robust technology. I think that Medusa is particularly interesting. Its application in proteins and peptides is, I think, kind of the sky’s the limit.

So first and foremost, I think that we have first-class technology here. I also think the people here are first-class. We have very talented people. What I think you’ll see is kind of a bit of an evolution or a metamorphosis to moving towards a more commercial model. Our objective here is to create profit and cash flow, and that’s a theme, the only theme that we’ll be talking about not only with our employees here but with people outside the company as well. We have a number of interesting partnership opportunities that can generate positive cash flow. Some of them we’d love to see be closer in time frame, but we have others that are—you know, that might not fill that gap.

Secondly, we are going to institute projects of our own into our existing pipeline, projects that we believe are ultimately going to have fewer risks associated with them, shorter development time cycles, and still though be commercially valuable. And we’ve actually already started that process, and so we’re going to continue to morph our project portfolio some as time goes on, and the ultimate arrangement is for those of us at Flamel to create a model that employs that state-of-the-art technology but at the same time allows us to better control our own destiny by having projects of our own, products that we can either market ourselves or projects that we can, if need be, license them. We can license them ourselves – we don’t need middlemen to do that for us. I think the faster we get onto that track – and we’re working on it now – the faster that you’ll see blue sky above.

But make no mistake about it – that’s our objective and that’s what’s going to happen here.

Operator

Thank you. We’ll move on to Russell Cleveland with RENN Capital.

Russell Cleveland – RENN Capital

Hi. Thanks so much. There seems to be a lot of uncertainty about Flamel in the marketplace, confusion I think is a good statement. I’ve enjoyed the call very much and it seems like we’re on our way. I’m wondering to add to this about investor relations, and let’s just start with this phone call. Now, I don’t know whether you expect people to get up at 5:30 in California – I’m in Dallas – but we need to rethink this. I mean, let’s not have conference calls when most of the country is asleep, and so I’m wondering whether we can change that. That should be an easy one.

Michael Anderson

You consider it changed. That’s a reasonable thing. What we try to do—

Russell Cleveland – RENN Capital

Well, I’m here at my house. I’m sitting here at my house anyway, but the investor relations program—and I’m all for companies and management spending time making money and not just doing investor relations. But are we going to have a program so that we can clarify—like, your statements today are very good, but an ongoing program I should say about Flamel so that we can end the confusion about our future.

Michael Anderson

Yes, sir. As soon as it’s reasonably possible, I intend to go out. We’re going to do our best to be proactive at healthcare conferences. We’re going to go out and talk individually to investors, but it’s been six weeks and in that six weeks I felt like we’d be better served by sitting here trying to sort through the things that we believe need to be done, and once we get everybody moving towards the same direction, then we’ll begin that activity. It won’t be that long from now, and I think that’s very important and I understand there has been confusion and there’s been questions about what all this means. I think that as time goes on, our results and the actions that we take will become obvious to shareholders, and in the interim we’ll do what we can to let people know of the new altered Flamel and what we expect from the business.

Russell Cleveland – RENN Capital

Great, well thanks so much. We’ll look forward to this.

Michael Anderson

You’re very welcome. Excellent.

Operator

And we’ll take our next question from Roger Bensen with Number One Corp.

Roger Bensen – Number One Corp

Hi Mike.

Michael Anderson

Hi Roger, how are you?

Roger Bensen – Number One Corp

About five weeks ago, you and I had a conversation and you went into your background much more extensively that had been in the press release at the time of the acquisition, and how you’d been with three other companies and had over a period of a relatively small number of years had taken revenues from virtually nothing to over 100 million in each of the companies. That’s certainly very commendable and I think that should be promulgated more. You also said that I was in for some good news on Eclat, that you were going to have a couple of NDA filings and so on and so forth that would move forward fairly quickly, and that within two years from the date of the phone call, which was, let’s say a month ago, that Eclat would bring in more revenue to Flamel than Flamel had cumulatively piled up over the 12 years that I’ve been associated with the stock. Now, that would be well over $100 million, so could you elaborate on that some for the other people on the conference call who didn’t hear that directly from you?

Michael Anderson

Well, I obviously remember our call and what I tried to describe to you and I’ve tried to describe over the first two phone call conference calls that we’ve had is the fact that we have—at Eclat, we had a number of projects that we had been underway with developing. That’s only moved forward since that time. We carefully, based on our commercial expertise and capability, have identified those projects, and what I’m really trying to explain to you is that I think those projects, if they work out as we’ve anticipated, could be sizeable and valuable and would create cash flow that could then be put back into developing our own projects here at Flamel. I think that’s a big plus, and I do think those projects are interesting and of such size that they could be very important for the future of our company.

The original plan that we had at Eclat was twofold – one was to develop projects that weren’t necessarily considered to be strategic but were more opportunistic, and those were the ones we’ve talked about, and then we had a number of other projects that we had identified that would have required some excellence in drug delivery technology. And those projects will be the ones that will really build a strategic focus with Flamel over the years to come, the projects that we’ll be able to commercially sell ourselves. So it’s a combination of both of those and we are very excited about those projects. As it sits right now, there’s no reason to believe that we won’t be successful with them.

Roger Bensen – Number One Corp

Okay, that’s good. I don’t know anybody at Deerfield. I’ve never spoken with anyone there, but they certainly have a wonderful reputation for being the best medtech investors around. They’ve put tens of millions of dollars into the Flamel stock and they backed your company Eclat, and then Eclat, if it’s going to do the things that you have just said it will do, it certainly could have gone public on its own at some point in the not too far distant future. And yet, both you and Deerfield have felt that it was better to merge it into Flamel than to go public on its own – okay. But the stock collapsed the minute the deal was announced. The stock would have to go up over 50% from where it is now to where it was when the deal was announced six weeks ago. The stock is selling below the lowest price that Deerfield has paid for the stock. I don’t see any evidence of either Deerfield or you buying stock in the market. What’s the story here?

Michael Anderson

Well, first of all I haven’t been able to buy stock because I’ve been blacked out, as you know, until we file the 20-F and now the 6-K. So you can stay tuned for that one, but that’s the law and I’m not interested in violating the law.

Number two is that as it relates to—you know, listen, as a former owner of a clot (ph) in part with a small interest, I did have some reservations; but I also, having come here to Flamel and becoming familiar with their technologies, I believe I see a really wonderful opportunity to take the technologies that have built Flamel and to create a set of projects around them that can be successful in the marketplace, projects that I believe can be successful in some cases over shorter time periods than other ones, and I still believe that. But that was a difficult decision in part.

I do think that this new Flamel with this new competency in marketing and understanding markets is a more valuable company than either one would be without the other, and I think that’s a plus. So in a nutshell, that’s why this was done.

Operator

We’ll take our next question from Peter Butler with Glen Hill Investments.

Peter Butler – Glen Hill Investments

Yeah, hi. Just a follow-up – it seems following Flamel over the last, God, more than 10 years, that it just appears from the outside that the company is being run by the CEO, and we hear from Sian four times a year. I’m wondering if you could maybe in the next six months or so raise the visibility on who else works for the company.

Michael Anderson

Absolutely we can, and you—as you’ve known for many, many year, this company has been driven by a number of first-class employees. If you go look at your 20-F, you’ll see the names of the key people. We have excellent scientists, we have excellent people, obviously, in finance and in manufacturing. We have people who are really good at what they do all throughout the company, and appropriately their names are listed in the 20-F and other legal filings, and they’re an important part of this equation. But I think your point is well taken.

Peter Butler – Glen Hill Investments

Okay. Well, thanks for the help today, guys.

Michael Anderson

You’re very welcome. Thank you.

Operator

That will conclude our question and answer session. I’d like to turn the call back over to Mr. Anderson for any closing or final remarks.

Michael Anderson

Yeah. Again, we want to thank everyone very much for joining us on the call today. I hope that if you’ve gotten nothing more out of this call that I’ve hopefully been able to convey to you an enthusiasm that I have for this new Flamel and for the opportunity that we have as an entity that not only does drug delivery now but also has some commercial capability in building our business, creating value for our shareholders, and becoming profitable. We’ll look forward over the next several months to updating you as our events progress, and we’re again thankful and appreciative of your time today.

Hope you have a wonderful day. Thank you.

Operator

Ladies and gentlemen, this does conclude today’s conference. We thank you for your participation.

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