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Executives

Michael Anderson - CEO

Siân Crouzet - Principal Finance Officer

Analysts

Matt Kaplan - Ladenburg Thalmann

Peter Butler - Glen Hill Investments

Jay Leopold - Legg Mason

Flamel Technologies (FLML) Q3 2012 Earnings Call November 5, 2012 9:30 AM ET

Operator

Good morning, ladies and gentlemen and welcome to the Flamel Technologies Announces Third Quarter 2012 Results Conference Call.

The following presentation regarding Flamel Technologies S.A. includes a number of matters particularly related to the status of various research projects and technology platforms that constitute forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The presentation reflects the current use of Flamel’s management with respect to future events and subject to risk and uncertainties that could actual results to differ materially from those contemplated in such forward-looking statement. These risks, include risk that product and development stage may not achieve scientific objectives or milestones or meet stringent regulatory requirements, uncertainties regarding market acceptance of products and development, the impact of competitive product and pricing and the risk associated with Flamel’s reliance on outside parties and key strategic alliances, these and other risk are described more fully on Flamel’s public filings except as required by law, Flamel did not intend and disclaims any duty or obligation to update or revise any forward-looking statements contained in this presentation reflect new information, future events or otherwise.

Please note this call is being recorded. (Operator Instructions). I would now like to turn the call to Mr. Anderson, CEO of Flamel Technologies. Please go ahead, sir.

Michael Anderson

Thank you. Good morning, ladies and gentlemen. Given that the operator has done such a nice job with the forward-looking statement language, I’ll dispose with a lot of that. But, we do appreciate your joining us today. I would like to mention to you of course, that there is forward-looking language in our commentary and in the press release and that we would encourage our shareholders to review the risk and any other disclosures set forth in our SEC filings all of which are publically available. Before we discuss our financial results and the pipeline, I want to make a comment on the update that we announced this morning regarding our Medusa-based beta interferon partnership with Merck Serono.

As we noticed in the press release this morning, on Friday, Flamel received notice for Merck Serono that it had decided to terminate for it’s convenience it’s development and license agreement with Flamel for long acting interferon beta-1a. The MS phase as you may know has certainly evolved since the beta interferon partnership was first conceived especially with the arrival of targeted oral therapies.

Despite determination, we remain highly confident that value and in then the utility of the Medusa hydrogel technology. The termination of our agreement thus provides Flamel the rights to apply our Medusa hydrogel technology to other beta interferons. We remained active in exploring all strategic options and given the promise that we've seen in the clinic, we may consider identifying an alternate strategic partner.

With that, out of the way, I am pleased to share with you some of the great progress that we've made as the business over this past quarter. Prior to the Éclat acquisition, Flamel was a drug-delivery licensing company with relatively little control over our products and news flows.

Now, with a fully-owned drug already under review at the FDA, Flamel is emerging as a more independent commercial stage company. The ability to complement our core revenue streams with new proprietary products is key to providing both sustainable revenue and earnings growths for Flamel. I’d like to be very clear here however, that despite the development of our own pipeline, we have not abandoned or even slowdown in the project side base side of our business. We continue to make strong progress on the business development front and we help to share more details on new deals in the coming months in quarters.

Now before we get into our financial results I want to highlight that our recent NDA submission for a new hospital based product was accepted by the FDA last month. The FDA’s PDUFA target action date for our NDA is May 31st, 2013. This is Flamel’s first every NDA submission and I am confident that our team has prepared it with the utmost quality, leveraging the wealth of expertise and experience we have in both clinical and in regulatory affairs.

While we await the FDA’s discussion, we are already preparing ourselves for launch and expect to be able to have the product available to providers and patients as quickly as possible after an approval. For that reason, if it’s approved on time, we expect the product to have a positive impact on our financial results next year.

For competitive reasons, we are not disclosing the molecule or the indication. But I can share with you that it’s targeted for the hospital setting and it could contribute up to $25 million to $35 million in additional annual revenues for Flamel.

Importantly, we expect the profitability of the drug to be on par with other proprietary pharmaceuticals with robust growths in operating margins typically seen in this space. Beyond the submitted NDA, the pipeline is progressing as expected. We believe that we're on track to file an additional NDA no later than early 2013 from our growing clinical portfolio.

At this point, we have more than a dozen molecules in various stages of R&D completion and development, including several in the clinic. Those products cover a gamut of therapeutic categories including CNS, hepatitis-C, heart disease, pain management and others. We have also inserted four internal projects where ultimately Flamel will either market the product itself or will directly license to a partner, who can more effectively monetize the project.

To provide you an update on our previously announced Interferon-alpha XL project, we're pleased that the results of the second phase 2b study will be presented at the 63rd Annual Meeting of the American Association for the Study of Liver Disease in Boston next weekend.

As we discussed before, we're not always at liberty to reveal everything about specific products in the pipeline for competitive reasons or in many cases, because our partners don't won't want their work disclosed. However, we are committed to increasing the visibility into our pipeline as our programs advance. We look forward to opportunities to share these additional updates from our pipeline as they become available.

Ultimately, all of us in the Flamel management team understand that sustainable growth for our business will come from a combination of expanding and advancing our existing assets and technologies, while pursuing the best strategic options externally. We've made quite a bit of progress already this year and we'll continue to press forward aggressively.

With that, I'll hand the call over to Siân Crouzet, Flamel's Principal Financial Officer. Siân will discuss the financial results from the recently concluded quarter.

Siân Crouzet

Thank you, Mike. Total revenue for this third quarter of 2012 was $5.4 million compared to $10.4 million in Q3 of last year. The decrease was primarily driven by lower product sales and services, $2.1 million this year as compared to $5.3 million last year. This decrease resulted from the signing of the new supply agreement with GSK in the third quarter of 2011. We concluded an up-front payment and modified pricing structure for purchases of Coreg CR's microparticles.

As per the other components of revenue, license and research revenues were $1.7 million in Q3 of 2012 compared to $2.7 million in 2011, reflecting in part the slowdown of our development efforts on behalf of Merck Serono. Other revenues from the quarter, primarily royalty income from GSK from the sales of Coreg CR, were $1.6 million compare to $2.5 million in the third quarter of last year.

Total costs and expenses during the third quarter of 2012 increased to $10.4 million versus $9.3 million in the year-ago period. This increase is essentially due to the inclusion of the Éclat related expenses not present during the prior-year period.

Costs of goods and services sold for the third quarter of 2012 were $1.5 million versus 1.1 million in the third quarter of 2011. Research and development costs in the third quarter of 2012 totaled 6.2 million compared to 5.5 million in the year-ago period.

On SG&A expenses were 3.1 million in the third quarter of 2012 versus 2.6 million in the third quarter of 2011. Total interest expense for the third quarter of 2012 was $1.4 million which includes $1.5 million of non-cash expense related to calculated interest expense on the consideration payable for the Éclat transaction, which is partially offset by interest earned on our cash balance.

Net loss for the third quarter of 2012 was $6.4 million versus a net income of $1.7 million in the year-ago period. Net loss per share was $0.26 compared to earnings per share of $0.07 in the third quarter of 2011. Excluding the impact of the re-measurement of acquisition liabilities, net loss and loss per share for the third quarter of 2012 was $5.3 million and $0.21. With respect to cash and marketable securities, we ended the quarter with $16.6 million compared to $24.5 million at the end of 2011.

I would now return the call back over to Mike.

Michael Anderson

Thank you, Siân. At this point, we would be happy to take any questions. Operator, if you could provide the instructions that would be great.

Question-and-Answer Session

Operator

(Operator Instructions) And we’ll take our first question from Matt Kaplan, Ladenburg Thalmann.

Matt Kaplan - Ladenburg Thalmann

I have few questions. First, starting with the NDA that you recently filed. You painted, kind of a brief outline for the NDA, which was recently accepted for review, the $25 to $35 million revenue projection. I guess, is this a best case scenario or is it a base case scenario, how should we think of this? I guess equal to that what does the potential upside scenario look like if this is the base case?

Michael Anderson

Well, good question Matt. Obviously, I don’t think it would be prudent to put a best case scenario and this kind of press releases we did when the NDA was accepted. I consider it to be a base case scenario, assuming that our existing plans come through as we project. There is certainly room for upside and we’ll do everything that we can to maximize the NDA once it’s approved into the marketplace.

Obviously, our inability to describe the molecule for you takes a little bit of luster way, it doesn’t put us in much of a position to be able to spell out with many kind of great clarity, but I think at the end of the day our shareholders will appreciate the necessity that we felt was necessary to protect the identity of the molecule, at least for the time being. Answer to your question, Matt is that I consider for the most part of base case scenario.

Matt Kaplan - Ladenburg Thalmann

And what would the potential upside, it looks like if this is actually kind of panned out to beyond what…

Michael Anderson

Well, we put personally wide range as you’re aware from $25 to $35 million at a typical branded pharmaceutical margin. It’s a great deal of flexibility on either side. I mean clearly there are some upside potential without putting a number to it and by the same token in all fairness they would certainly potentially see some downside too. We feel like it’s a pretty good number and should give you at least some sense of what the products are capable of becoming. I would also point out that I think it’s important that you look at what the numbers that we issued relating to that molecule and how they reflect to the historical revenues generated by Flamel. So it doesn’t take much to see that if our other existing partnered business continues forward, if we continue to move our pipeline through, we should certainly have upside to the revenue numbers that you’ve seen over the past couple of quarters and then you can lay around on top of that, the revenues generator from this molecule and from the other molecules that will file in the not too distant future.

Matt Kaplan - Ladenburg Thalmann

And just one another question on the NDA. I guess in the press release you called this a new hospital product. Was the product previously available and I guess either for use in the hospital or outside of the hospital or this is something that’s new to the hospital setting?

Michael Anderson

Yes. Well, I think we’re talking about its new for Flamel. We haven't gone in to describe whether it’s an existing product or a new chemical entity, but quite candidly you would know yourself clinicaltrials.gov any kind of extensive clinical studies that would be normally undertaken with respect to a new chemical entity would have had a great feel of this (inaudible).

Matt Kaplan - Ladenburg Thalmann

And then the second NDA expected out of the Éclat pipeline, is that potentially still on track for later this year. You said in your prepared remarks that it should be by totally next year or…

Michael Anderson

Yes. I think what we just said was that we would expect potential for another filing by early 2013 at the latest. So for whatever that may mean to you, we’re on target as we described earlier in the year and we provided here a little more color as to that filing.

Matt Kaplan - Ladenburg Thalmann

Did you, I guess changing topic a little bit, partnering update on alpha interferon, how’s that progressing? And what’s the potential timeline for getting something done there, the alpha interferon?

Michael Anderson

Well, we’ve been as I think you're aware, we’ve talked about working on this and having some fairly mature discussions ongoing for at least the two quarters that I've been here and that we still have very mature discussions and I feel like we're getting pretty close to it, interferon-alpha XL. We're also very excited about the presentation that will be made in the meeting in Boston over the course of this weekend.

Matt Kaplan - Ladenburg Thalmann

It’s obviously hard to predict, but do you think you can get something done in the next six months or what's the…

Michael Anderson

Well, I would certainly hope so. I would certainly hope so. The deal with or the issue with business arrangements and business development partnerships is that, they can be proceeding along as nicely as anything and the 12th hour take turns as nobody ever anticipated. We don't anticipate that happening but until it's signed and the ink’s drive, there is no guarantees on any of this, but we've been working on this for a while and even with the complexity of this kind of a product in this kind of a deal, it just, always seem to take a little longer than you think. But we have done extremely well and we're moving through and we’d hope to have something positive on this before too long.

Matt Kaplan - Ladenburg Thalmann

Okay. And let's talk a little bit about your cash position and your burn in a relationship to the potential timing for the revenue ramp for the NDA that's filed, if it receives approval, I guess…

Michael Anderson

Well, as you saw from the press release at the end of September, we had $15.6 million worth of cash and marketable securities. We’ve obviously the inclusion of the in finishing up of the development of the projects that were original Éclat projects, the cost has taken us some money to do so far, there’ll be some continued cost and so we're going have to be very careful. But at this point in time, we feel like our cash is sufficient and we're being as good as we can stewards of capital and believe it will be in great shape.

Matt Kaplan - Ladenburg Thalmann

In other words, your cash is sufficient to make it to profitability?

Michael Anderson

Yes. If you look at the burn or cash so far then theoretically that should hold us at least through the middle of next year, if not beyond that. And there is something that obviously we’ll continue to look at. We won’t take chances with that.

Matt Kaplan - Ladenburg Thalmann

From what you’re saying your capital needs at this point you don’t need to raise additional, I don't want to put words in your mouth, you need to raise it? I just want…

Michael Anderson

Yes. I think, what I’m really trying to tell you is this is something we’re conscious of the cash balance based on historical spending, the cash balance should be sufficient. But we also know that we have some to ambitious plans. We want to make sure that we have the resources to be able to capitalize on those plans and so it’s something that we’ll be looking at is probably the best I can define for you. Not trying to be evasive but I don’t have much more cut and dried answer for that I’m sorry.

Matt Kaplan - Ladenburg Thalmann

And there’s couple of other questions and I’ll jump back in the queue. Can you give us a quick update on the Trigger Lock programs in LiquiTime programs as well?

Michael Anderson

Well, we have just for your information, projects ongoing and with both of those technologies; we have in Trigger Lock, which we described earlier today as our pain management opportunity. We have partnered arrangements in that area and those partnership projects are moving forward. And so, we’re very existed there maybe not too far from being able to be proud. So we have several partnerships actually with Trigger Lock and we also have couple of partnerships and an internal project with our LiquiTime, so those continue to move forward too.

I believe that our Trigger Lock platform is excellent and that may very well be one of the technologies, it has the ability once FDA announces its guidelines or determination of what abuse resistant, we believe Trigger Lock is going have a significant role in that area. In terms of LiquiTime which typically you think of liquid, you think of pediatric use. There are some interesting opportunities that with LiquiTime technology now with the pediatric use but also for geriatric use which I think is up and coming, kind of in areas we move forward and we’ve identified some opportunities there and we’re going to continue to move both of those platforms forward.

Matt Kaplan - Ladenburg Thalmann

It just sounds clear in terms of the Trigger Lock. Did you say that that is close to being filed for approval or what stage is development…?

Michael Anderson

Well, let me just suffice it to say because, need one of our partner’s in the case of Trigger Lock is willing to allow their maintenance to be used, it kind of put us in a bind, let me suffice it to say that both of the projects are moving forward and we have multiple molecules involved there.

Operator

Moving now, we will take our next question from Peter Butler, Glen Hill Investments.

Peter Butler - Glen Hill Investments

Hi. Yes, going back over the last several years, it just seems that Flamel’s overly conservative look on things has hurt shareholders and I’d be willing to bet, if your lawyers are allowing you to say out loud 25 to 35, you probably internally think that the number really is 60 to a 100 and I have said many times on these conference calls that I would save some money and unload these overly conservative lawyers that are giving you advise, but that’s my opinion. Could you speak some about your objectives for next year and the important thing is not what happened in the previous quarter, but what’s the company going to look like in the third quarter next year?

Michael Anderson

That’s an excellent question. And frankly, I am not at liberty to talk about each and every one of the objectives we've set internally, but I can give you the one that makes, that it is by far the most important and that is, in my view, my personal objective is this company is going to be profitable by the fourth quarter of next year on a sustainable basis. And I think in order for us to do that, has required us to change some things that we have been doing, some of the processes and procedures that we have used internally. As you know we have remapped pipelines, we've restructured organizations, we've made an awful lot of changes internally which in my view were absolutely essentially for us to be able to reach that objective.

The next thing is to make sure that the partnerships that we have are good partnerships with partners who are not only committed to the molecules that we get, but partners who have the same desire to move projects forward at the same pace we do that’s important. Next is, important is to get these projects that were inherited by us through the acquisition of Éclat, get them submitted and get them approved into the marketplace to be able to generate both cash and earnings and to be able to plough that monies that we can generate from those products back into the continued development and enhancement not only of the technologies themselves, Peter, but of the pipeline as well. And we're doing all those things. But there, we have also, we've laid out as a company for our own internal use, specific objectives that we expect to accomplish over the course of the year, but number one on the top of that hit parade is to be profitable, by no later than the fourth quarter of next year.

And remember too that as you do these things that you have some extraordinary source of things that I want to call out to you. Number one is, is that when we get a product approved we have to have inventory, they are costs associated with inventory bills. We have to consider those things. Since the acquisition of Éclat, the Congress and the FDA have increased user fees for NDAs from what was previously $750,000 to $2 million per application. For Pfizer, that's not an overwhelming number but for companies the size of Flamel, that's something that we have to consider and so we have all of these things that we have to motor through in order to become profitable and we're laying and we already have laid in the plans to do just that.

So, without pin pointing to all the granularity associated with that that is my personal objective is to have this company profitable quarter after quarter after quarter. No longer do we believe it's going to be acceptable to be profitable for a quarter, miss for three, profitable for a quarter, miss for two, we're talking each quarter. And that really is the beauty of what this new approach is all about, it allows us to have a better chance to do that. The Merck Serono deal is a great example of that. I mean, to be totally dependent upon what partners want to do, is difficult in today's pharmaceutical marketplace in my view and we need to take those steps that are necessary so that we can reach that kind of an objective. That’s a long answer to a short question, yes. That stuff is important to understand.

Peter Butler - Glen Hill Investments

Okay. In regard to the alpha interferon, with the previous management, it sounded like that deal was all but signed, months and months and months ago and you’re describing the pace of the negotiations as mature and suggesting or hinting the things might be close. So at this point you have to have some idea of what sort of money we’re talking about. And I think it’s really critical for you guys to start ringing the cash register and to get some money coming in, in some size. And I would think that a drug that has successful phase II results is worth a hell lot of money, and so I am assuming that you are going to ring the cash register sort of big time when you do sign something on the alpha interferon. Is that misplaced?

Michael Anderson

No. Well, let me just point out two things. Number one, that’s not misplaced. We’re going to monetize that project and the money we've spent on the interferon alpha as best we can possibly monetize them. And so the answer is, we’re not going to give it away. But the same token, I think you have to be appreciative with the fact that this whole hepatitis C business is changing right in front of our eyes and that while there will always be a market for Ribavirin and for interferon alpha which today are the combinations considered to be the gold standard. As we go down the road, that’s going to be tempered some, because of new entities, oral therapies and the like. So the answer to your question is, we've spent a great deal of money, internally driven and generated work on interferon alpha and we’re obviously going to have to do what we can to monetize that for the benefit of our shareholders. I can also tell you that when we do that deal, we will make sure that we're able to talk about it and provide some sort of context around the value of it to the company.

Peter Butler - Glen Hill Investments

If I could suggest a very optimistic forward looking scenario, there is a couple of questions attached. What is the size of your tax loss carry forward now and does the tax rate on royalties in France still roughly 17%?

Michael Anderson

Okay. We’re going to have check on that and we may not have that here. I think the NOL carryover last I saw was $165 million or give or take in terms of dollars and I have no clue on the royalty rate being any different in France than it has been in the past and I’ll take your word it is 17% right. We don’t have that in front of us.

Peter Butler - Glen Hill Investments

So the last question is Mike are you still charming and after being on board for couple of quarters, are you more or less optimistic about what you are seeing?

Michael Anderson

Great question. I don’t know whether anybody would ever describe me as charming, but I can’t. But I still have the utmost belief in what we’re doing here. I believe this technology is world-class. I believe that the push-end set in the right direction, it can be extremely valuable to the company and therefore to the shareholders. We are working and doing lots of things, most of which at this point are not newsworthy in terms of the press release, but they are absolutely critical in getting our business where it needs to be. And frankly, I believe we've made a lot of positive steps in that direction and I think that as 2013 rolls around, I believe you are going to see us perform differently. And that’s why we are here. All of our employees know that, they feel that. They want to be successful and I think that’s 40% of the trip is having everybody on the same waypoint wanting to enjoy the same success. So, we’re going to work, I do look worse than I did when I came here six months ago though.

Operator

(Operator Instructions) We take our take next question from Jay Leopold, Legg Mason.

Jay Leopold - Legg Mason

Hi. I just had a quick question on your NOL, is it to monetize and where would you consider tapping your NOL as a source of funding in terms of priorities of other sources of funding including potential streams of profits?

Michael Anderson

Fantastic question, NOLs in perhaps my understanding and our understanding under the right circumstances are monetizable. They require some structuring and that sort of thing. I don’t view the NOLs as in themselves Jay, as being the number one source right at this very instant of how we might go about signing cash if we needed too. But we, as I think I’ve mentioned to you in the past and others, there is nothing here that (inaudible). In other words, what we do here is drug delivery technology, anything else will try to find some way to be able to monetize. We can do that. let’s just assume for a moment that the NOLs are still worth $165 million, then you would look at that somebody 33% tax bracket would have about $50 million worth of value, obviously it has greater value to somebody who is making money in France today. And then you’re obviously going to offer some sort of a discount on top of it. So it is a way that can be monetized, it has to be done correctly, it’s quite complex to do. And it’s something certainly we’ll look at and we have looked at as we go down the path.

We have a number of avenues open to us and if we need to go down any of those and so we’re going to be very good, very prudent about the process and making sure that we take advantage of everything we have and I think those NOLs are an certain asset, actually.

Jay Leopold - Legg Mason

What avenue or avenues would you care to list just generically that would be more advantageous than selling an NOL from a shareholder friendly standpoint?

Michael Anderson

Well, I think looking at I don't want to go (inaudible) projecting something, looking at monetizing non-strategic assets. I think the one thing today we’re not interested in doing is selling what technology platforms, I mean that’s what we’re all about, anything else it’s here including those NOLs it is up for grabs. So I’m not suggesting that there is anything that would be value today for shareholders, but it’s something that we are looking at and if we got to the point where we needed to get some cash that would be something we would look at.

Jay Leopold - Legg Mason

The non-strategic assets and NOL monetization, you don’t have a whole lot of debt, but I assume issuing debt would be on your list of somethings to bridge, maybe a three to nine month period as well.

Michael Anderson

Yes.

Jay Leopold - Legg Mason

And then selling equities, would that be in your bottom of the list?

Michael Anderson

That would be, at the total, bottom of the list.

Jay Leopold - Legg Mason

Yes. I think making that clear is a good thing, so thank you.

Michael Anderson

Yes. Listen, we’re not interested in diluting shareholders, we were trying to create value here. Part of our strategy and our plan here and at which we’re moving forward is getting our business kind of in some regards rebuilt if you want to say it. And so the things that we don’t want to do along the way or get rid of what our business is which is technology and we're not interested in diluting our shareholders.

Jay Leopold - Legg Mason

Okay so, if you have more than enough avenues to bridge any short period of time.

Michael Anderson

We believe, if we do, yes, Jay.

Jay Leopold - Legg Mason

Inventories, et cetera?

Michael Anderson

Yes.

Operator

And this time that will conclude today’s question-and-answer session. I’d like to turn it over to Mr. Anderson for any additional closing remarks.

Michael Anderson

Sure. Well, thank you all very much again for joining us today. We will look forward to having continued announcements to make to you as our business moves forward and we’ll be working very diligently to make sure as many of them as possible are promising and good ones. So with that, we wish you a good day. And thank you again for your support.

Operator

Thank you. Again, that will conclude today's conference. We thank you for your participation.

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