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Flamel Technologies SA (NASDAQ:FLML)

Q2 2014 Earnings Conference Call

July 29, 2014 10:00 PM ET

Executives

Bob Yedid – ICR Investor Relations

Michael S. Anderson – Chief Executive Officer

Steven A. Lisi – Senior Vice President, Business and Corporate Development

Siân Crouzet – Principal Financial Officer

Analysts

Caroline Palomeque – JMP Securities LLC

Matthew L. Kaplan – Ladenburg Thalmann & Co. Inc.

John T. Boris – SunTrust Robinson Humphrey, Inc.,

James F. Molloy – Summer Street Research Partners

Scott R Henry – Roth Capital Partners.

Jason M. Gerberry – Leerink Partners LLC

Operator

Good morning ladies and gentlemen and welcome to the Flamel Technologies’ second Quarter 2014 Earnings Call. Please note today's call is being recorded.

I would now like to turn the call over to Mr. Bob Yedid. Please go ahead, sir.

Bob Yedid

Good morning, and welcome to Flamel Technologies’ second quarter 2014 conference call. This is Bob Yedid of ICR Investor Relations.

Before we begin, I will start with some cautionary statements. The following presentation regarding Flamel Technologies includes a number of matters, particularly as 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 views of Flamel’s management with respect to future events and is subject to risks and uncertainties that could cause actual results to differ materially from those contemplated in such forward-looking statements. These risks include risks that product in development stage products may not achieve scientific objectives or milestones or meet stringent regulatory requirements; uncertainties regarding market acceptance of products in development; the impact of competitive product and pricing, and the risks associated with Flamel’s reliance on outside parties and key strategic alliances.

These and other risks are described more fully on Flamel’s public filings, including the Form 20-F for the year-ended December 31, 2013. Except as required by law, Flamel does not intend and disclaims any duty or obligation to update or revise any forward-looking statements contained in this presentation to reflect new information, future events or otherwise. After the prepared remarks we’ll be opening the call to a question-and-answer period.

At this time, it’s my pleasure to turn the conference call over to Mike Anderson, Chief Executive of Flamel Technologies. Mike?

Michael S. Anderson

Thank you, Bob. Good morning ladies and gentlemen. Thank you very much for joining us again today. I’m pleased to report that Flamel has made significant progress in a number of commercial and pipeline areas and advanced our standing as a specialty Pharma Company with outstanding drug delivery capabilities.

I’ll focus my remarks a number of topics during today’s call, including the FDA approval of our second NDA for VAZCULEP developments in the neostigmine market progress with our other unapproved marketed drugs and of course our pipeline and proprietary products. After my remarks, Siân Crouzet our Principal Financial Officer will discuss our second quarter of financials.

At the end of last month we were pleased to get FDA approval of our second New Drug Application for Phenylephrine Hydrochloride, which we will sell under the brand name VAZCULEP. This is the next product from the Eclat portfolio of unapproved marketed drugs to be approved.

Following the FDA’s approval of course a box reverses in May 2013. Both of these drugs are used in the hospital setting. VAZCULEP injection is indicated for the treatment of hypotension resulting primarily from vasodilation in the setting of anesthesia. For the most part phenylephrine hydrochloride is used in operating rooms and is injected intravenously either as a bolus or in a dilute solution as a continuous infusion.

Flamel expects to launch VAZCULEP in the next few months in 1mL single use vials, and of course in a 5 mL and 10mL pharmacy bulk package vial. One other company has FDA approved version of the 1 mL single use vial. Based on our knowledge there is another company that offers unapproved versions of phenylephrine hydrochloride, but only in the 5 mL and 10 mL pharmacy bulk package vials.

We are encouraged that VAZCULEP is the only FDA approved version of phenylephrine hydrochloride to be available in all three vial sizes, which will be a great covenant to both hospitals and physicians. As a general rule, hospitals do not prefer to by separate sizes of the same product from different vendors.

As you may recall, we’ve received a Complete Response Letter or CRL from the FDA on April 28, which was due to a couple of unresolved deficiencies found in the manufacturing facility of our Active Pharmaceutical Ingredient or API supplier. Those deficiencies didn’t directly apply to our drug. Subsequently our API supplier informed Flamel that the issues were resolved and the facility was expectable to the FDA, which allowed us to resubmit our NDA on June 6 or just over one month after the CRL much earlier than our original estimate.

In addition, while the FDA classified our submission as a Class 1 response, which meant a two month review and a PDUFA action data on August 6. We are pleased that VAZCULEP was approved on June 30, or just 3.5 weeks after the date of our resubmission. This demonstrates the quality of Flamel submissions to the FDA and our positive working relationships with the FDA and with other third-parties.

We expect to launch VAZCULEP before the end of the third quarter. The current market sales for phenylephrine hydrochloride in both the approved and unapproved versions for estimated to be about $50 million per year. As our FDA approval was received less than one month ago we believe it is much too early to discuss our pricing and other market assumptions for VAZCULEP. Although we do expect to discuss this approved product with investors on subsequent calls.

Second, let’s turn to Bloxiverz. The first and only FDA approved version of neostigmine methylsulfate and injectable product used in hospital operating rooms. Please note that neostigmine methylsulfate has been in short supply on and off again for over two years and had been listed on the FDA’s drug shortage list. Flamel was listed as one of four manufacturers since our approval and launch last year. We are very pleased that on June 19, FDA changed the status of neostigmine to resolved from the currently and shortage listing, and listed Éclat Pharmaceuticals as the only listed supplier of the drug.

We believe Flamel’s steady stream of communications with the FDA about the volume of product manufactured through our contract manufacturer and the company’s strong inventory position it all major drug wholesalers and within our own distribution facilities was important to the FDA in making this decision. Our inventory is sufficient to supply 100% of the markets needs for neostigmine today and we will continue to build inventory due to the FDA’s recent actions.

As a follow-up to the FDA’s actions on June 19, we have been in frequent communication with the FDA with regard to Bloxiverz. We look forward to learning more about any specific actions that the FDA may take in the very near future with regards to the manufactures of unapproved product. If and when Flamel receives a formal communication from the FDA on the neostigmine market, we will communicate that promptly to all investors.

Turning to our third unapproved marketed opportunity, we are on track to file a new drug application for our third product from the Éclat pipeline in the second half of 2014. Management’s recent discussion to redirect our resources from the filing of Eclat number three to Bloxiverz and VAZCULEP, paid off. We work to provide additional inform of the FDA requested owner of Bloxiverz’s manufacturing and inventory levels and deal with any remaining questions which allow them to act on the drug shortage situation and designate Elcat as the only supplier.

In addition, we focused intensely on the resubmission of the NDA for VAZCULEP and received an NDA approval well ahead of our original expectation and the amended FDA action date. In that same claim management must evaluate the best use of our limited resources in evaluating our NDA submissions for unapproved marketed drugs and our pipeline of exciting proprietary products, with regard Elcat number four we will delay the NDA submission of that product from last second half 2014 to mid-year of next year 2015.

Since there are limited numbers of these unapproved products to pursue that are commercially attractive. It does not make sense to expand our organization to handle Eclat number four until we are completed with the submission and subsequent acceptance of Eclat number three.

Similarly in the proprietary pipeline we have meaning exciting opportunities. Each of those drugs is prioritized based on a detailed annualizes of the market size, the cost and length of clinical testing, clinical regulatory risks and expected competition. Looking forward, Flamel will need to make an investment in our infrastructure in product development and clinical testing, manufacturing, quality and regulatory submissions to insure progress with our current pipeline. Based on this analysis we’ve decided to focus on our current programs using Micropump, LiquiTime and Trigger Lock drug delivery platforms.

As well as, the Medusa platform applied to once weekly formulation of exenatide. For now we have decided to put extended release Medusa human growth hormone product on hold. This injectable product uses Flamel’s Medusa technology applied to recombinant human growth hormones. The clinical testing for this product will be lengthy it’s going to be very expensive and based on an analysis of the timelines and required resources we will move this product down the listed of our pipeline priorities. We will focus our resources on five key proprietary products.

As outlined in our Investor presentation which is posted on Flamel’s website. Over the next six months to nine months we expect to have clinical data on four of these products and to start a clinical trial on the fifth in 2015. The first product involves exciting data that we presented last April on sodium oxybate using Micropump, our flexible technology for the all delivery of small molecules. Micropump is a proven technology and has been approved the Coreg CR products since 2006.

In April, we announced positive results from a First-in-Man clinical study in healthy volunteers using our Micropump technology applied to sodium oxybate. Sodium oxybate of course is sold as a branded drug Xyrem in the United States by Jazz Pharmaceuticals and it is sold outside the U.S. under licenses from Jazz. Reported worldwide sales of Xyrem in 2013 were $569 million. The study identified formulations with the potential to eliminate the second night time dose for patients suffering from narcolepsy.

The ability to administer a single bedtime dose rather than requiring the patient to set a clock for a second dose would be considered to be a major advantage in dosing. The initial trial was in 16-patients in three different formulations of Micropump sodium oxybate and Xyrem at nightly doses of 4.5 grams with an extension phase at 6 grams for a successful Micropump formulations.

Fortunately we have been granted regulatory permission to extend that protocol and to perform a stuffy where additional subjects will be dosed with 4.5, 6 and 7.5 grams. These initial results are encouraging to us and I want to reiterate our development program for Micropump sodium oxybate.

Following the just mentioned PK study, we will perform another study to evaluate certain pharmacodynamic endpoints with results expected in the second quarter of 2015. Now this study is not a registration study. We plan to meet with regulatory authorities prior to embarking upon any registration studies which we will expect to began before the end of 2015. Based upon FDA requirements and the time needed for enrollment, we anticipate and NDA filing in late 2016. We will of course keep investors and analysts up-to-date on our progress.

I would like to update you on the other drugs in our pipeline as well. With respect to LiquiTime, we have one program each in pain and respiratory that will use our LiquiTime technology which provides controlled release of drugs in oral liquid form principally for pediatric and geriatric patients. We expect to have clinical data on the pain product and on the respiratory product respectively in the second half of this year 2014. Both of these products are expected to compete in large OTC markets.

With respect to Trigger Lock, Flamel currently has one pipeline product in pain that uses Trigger Lock technology. Trigger Lock is specifically designed to provide abuse resistance for long acting opioid analgesics, which as you are probably aware, is a major problem in the U.S. and the subject of specific FDA regulations for new opioid pain products.

Trigger Lock products are designed to be resistant to abused by extraction and subsequent injection, crushing and snoring as well as resistant to the extraction of the drug using alcohol. Recently we did have a pre-IND meeting with the FDA together more clarity on our planned clinical programs and we will start a clinical trial using Trigger Lock shortly and expect to report initial clinical data sometime around the end of 2014.

And then Medusa. As promised in late June, we announced pre-clinical data on a once weekly formulation of exenatide, based on our Medusa platform for injectables using a hydrogel depot formulation. We had not previously disclosed our work on exenatide, at GLP-1 agonist used to treat type 2 diabetes. The product demonstrated close to 100% bioavailability with no initial release spike or burst effect in plasma.

Two successive injections were administered with very similar release profiles. There were no adverse clinical signs and excellent tolerability was observed. The pharmacokinetic profile from this animal model is compatible with a release over one week in humans. We expect to present human clinical data in the second half of 2015.

Overall there are five programs in our proprietary pipeline on which Flamel plans to work actively and work actively and where the company has 100% rights. More over we expect to had new products to our proprietary pipeline over time they will allow us to leverage our capabilities and showcase the patent did drug delivery platforms. We hope to provide updates on additional molecules in our mid-term proprietary pipeline in various stages of pre-clinical development prior to the end of 2015.

We would also like to point out that we have mitigated some risk to the R&D pipeline by using non-pharmaceutical compounds where both efficacy and safety were well characterized. Of course, there are always risks to execution and timing.

With regards to partnered programs, we would like to comment on one of our partnered programs that did use the Medusa technology. While pre-clinical proof-of-concept data for a cardiovascular drug was technical successful.

Our partner a large multinational Pharma Company decided not to move forward with the product as it went through the typical process of prioritizing its pipeline products. This underlines clearly the reason for the change and Flamel’s corporate strategy about two years ago to focus on our pipeline products where we have 100% ownership of the drugs and directly controlled product development and the regulatory pipeline.

And with that, I would like to turn the call over to Siân Crouzet, our Principal Financial Officer for discussing of the second quarter financials Siân?

Siân Crouzet

Thank you, Mike and good morning. Flamel reported total revenues during the second quarter of 2014 of $8.1 million, compared to $5.5 million in the second quarter of 2013. Products sales and services revenues in the second quarter of 2014 total $4.1 million, compared to $2.2 million for the year ago period. The increase is due to the continued sales of Bloxiverz.

Costs of goods and services sold for the second quarter of 2014 were $1.6 million compared to $1.3 million in the prior year period. The increase was due to the cost of sales of Bloxiverz. Research and development costs in the second quarter of 2014 totaled $6.7 million versus $7.3 million in the prior year period.

Selling, general and administrative costs of $4.3 million in the second quarter compared to $2.7 million in the second quarter of 2013. This increased resulted from the cost of post-marketing studies requested by the FDA, and to increased legal costs. We continue to amortize R&D assets associated with the development of Bloxiverz. Amortization expense was $2.9 million in the second quarter of 2014. This is a non-cash expense and we will be amortizing these R&D assets over further two and half years.

Total net interest income was $94,000 in the second quarter of 2014, compared to interest expense of $64,000 in the second quarter of 2013. Interest expense was largely eliminated with the company’s repayment of nearly all of its debt and lines of credit with the portion of the net proceeds from its offering at $12.4 million ADSs in mid-March of 2014. Net loss on a GAAP basis for the second quarter of 2014 was $21.1 million versus $32.9 million in the year-ago period. Loss per share basic and diluted was $0.55 in the second quarter of 2014 compared to $1.29 in the second quarter of 2013.

In addition, we provided certain non-GAAP data that allows investors to evaluate the company’s ongoing operations. The adjustments excludes fair value remeasurements, and amortization expense directly associated with the acquisition of Eclat on an after-tax basis, assets impairments, effects of early reimbursements of certain debt instruments and includes earn out a royalty payments, due to associated with the acquisition liabilities and royalty agreements.

Adjusted net loss for the second quarter of 2014 was $4.9 million versus our adjusted net loss of $4.5 million in the prior year period. Adjusted loss per share basic and diluted was $0.13 in the second quarter of 2014 compared to an adjusted loss per share of $0.18 in the prior year period. With respect to cash and marketable securities, we ended the second quarter of 2014 with a total of $27.9 million, reflecting a cash use with approximately $5.7 million over the quarter.

With that, I will now turn the call back over to Mike.

Michael S. Anderson

Thank you, Siân. We are very encouraged with the progress that we are making at Flamel. The rapid turnaround from the VAZCULEP CRL on April 28 to the FDA approval on June 30. I think demonstrates the quality of our work and the dedication of our employees.

In addition, we continue our discussions with the FDA on the neostigmine market and expect that actions by the unapproved manufactures or the FDA will be an important next step in the marketplace for us. In terms of our pipeline we continue to provide visibility to our shareholders into our important pipeline products such as sodium oxybate as our product programs advance and meaningful updates become available.

On a closing note, I want to mention that we continue to add valuable resources and leaving Flamel forward. At our last annual meeting we added two new Directors to our Board including Ben Van Assche, who was the former head of Global Pharma that UCB Pharma as well as holding senior level positions at Alcon and Baxter. He remains active in the healthcare industry today. Ben brings additional pharma experience to the board and worked on the product launches of both Zyrtec and Keppra. Our other new director is Christoph Navarre, the Director General of Moët Hennessy, the Wines and Spirits business of the Louis Vuitton Group.

Christoph has outstanding business experience across several industries over the past 35 years and he is an influential member of the French and European business communities. We appreciate your participation on today’s call and before we begin questions, I would like to introduce to you as most all of you already know Steve Lisi our Senior Vice President of Business Commercial Development, who will join both Siân and I in taking your questions.

So at this point, operator I would like to open the call for any questions.

Question-and-Answer Session

Operator

Thank you, sir (Operator Instructions) We’ll take our first question from Jason Butler with JMP Securities.

Caroline Palomeque – JMP Securities LLC

Hi, this is Caroline in for Jason. First a couple of questions, the first one is just about what you think your current market share is for Bloxiverz right now and then if you could just also talk about your – the market dynamics in VAZCULEP or a little bit more about your commercial strategy, I know you cant talk about pricing, but if you just elaborate more on that as well. Thanks.

Steven A. Lisi

Sure, we would be glad to. First of all with respect to Bloxiverz as you may recall in the first quarter, we reported revenues that reflected there having been a – at times during that quarter meaningful shortage of product in the supply chain and so as a result we were able to pick up some of that business.

And then in the second quarter the one we just included, we didn’t have that same opportunity both of the two unapproved manufactures were seemingly backing inventory positions and obviously based on the difference in pricing we are able to recapture share that in some cases they had lost in Q1.

So as we closed out the end of second quarter, our sales and I’m talking here about recognized revenue, you will remember that because we are a new marketer and because we don’t have a lot of history with Bloxiverz that revenue recognition is an issue and their parts of what we've shipped that we have not recognized. Our sales were $2.2 million for the quarter and in terms of market shares in the neighborhood of 10%. Where we will move the needle clearly is when the FDA moves to remove those unapproved products from the marketplace.

With respect to VAZCULEP as we just mentioned earlier we contemplate or anticipate launching the product before the end of Q3, this is an interesting kind of a product as we descried that is already one approved 1 mL product but now we are having the only approved iterations of both the 5 mL and 10 mL pharmacy bulk pack puts us in the position to add value to hospitals. So remembering that phenylephrine as what is the case with neostigmine is a product that’s been used for years and really doesn’t require any kind of typical conventional detailing and such.

We’ll do everything that we can harvest the shares that are currently out there by the two people today in much the same fashion that we've made Bloxiverz known anyway to the hospital community for the first year of its being on the marketplace. As we get closer to the launch date the pricing will clearly be available as you would expect with regards to people like First Data Bank and Gold Standard and so forth. Did that answer your question?

Caroline Palomeque – JMP Securities LLC

Yes, great. Thanks.

Operator

Next we’ll go to Matt Kaplan with Ladenburg Thalmann.

Matthew L. Kaplan – Ladenburg Thalmann & Co. Inc.

Hi, good morning.

Michael S. Anderson

Good morning Matt.

Matthew L. Kaplan – Ladenburg Thalmann & Co. Inc.

A couple of question on Bloxiverz. Can you give us a sense in terms of how to interpret the listing – the fact that Bloxiverz has been only listed product on June 19 with respect to resolutions of shortages?

Michael S. Anderson

Well you know I mean I cant speak for the FDA Matt, but I think that in our view one of the issues that it held them back from acting upon the policy that they set into place was the notion that neostigmine which in their mind is a medically necessary drug, has been in an out of supply over the year and a half, prior to the introduction of Bloxiverz and it continues that way even against our argument that there was plenty in the marketplace, because we knew we had enough to supply at our warehouse, but we are something in my view something of a new entity to the FDA, I think it has taken sometime for us to get comfortable and for them to get comfortable with us, our ability to supply, our supply chain relationships and on and on.

We have always known them to be good, but I'm not sure the FDA had that same sense of comfort that we did, but I think finally they’ve gotten to the point where they did that. So while I can’t give you an official FDA response to why they remove those products, in my view it’s a precursor to their taking the next and the most logical step and that’s of course the step we’ve been looking for and that’s their removal of the unapproved products from the marketplace. And unfortunately that’s about the best I can tell you today.

Matthew L. Kaplan – Ladenburg Thalmann & Co. Inc.

Okay, in terms of your frequent communications with the FDA since the June 19, which you mentioned. Has those focused on your ability to supply the market or what have those communications been?

Michael S. Anderson

Well, certainly that’s been a major part of it and that’s why I think we feel somewhat comfortable believing that the FDA having removed it from being a drug shortage product almost overnight had finally become comfortable our ability to supply. Our conversation have been involved a number of issues which typically we wouldn’t talk to in detail or in specific detail, but you can be assured that our ability to supply is one of them and there are number of conversations and communications that we’ve had with the agency all throughout this process, but I would also say they picked up a lot of steam over the last couple of weeks.

Matthew L. Kaplan – Ladenburg Thalmann & Co. Inc.

And In terms of what your sense is for the second half of the year for Bloxiverz, obviously its all dependant on what the FDA does and the actions that they took in terms of moving unapproved products, but what is your sense is the second half of 2014 looking like a better opportunity for you with respected Bloxiverz?

Michael S. Anderson

So let me try to answer your question this way Matt. We believe this policy is something the FDA is committed to that is the removal of these unapproved products. If you go do the work, I think each one of them to-date and each of them going forward will have a slightly different nuance to it from time-to-time. In my view we are very optimistic that the FDA will take to action that it needs to take and we believe and that it will be done sooner rather than later and once it does then we will have the opportunity to be in the marketplace, those who have invested in us and followed us have expected all – and that we have expected all along.

Matthew L. Kaplan – Ladenburg Thalmann & Co. Inc.

Right

Michael S. Anderson

So I would say personally while we can’t speak to the FDA, personally we are very optimistic that we are on the right track and that would be a logical next step.

Matthew L. Kaplan – Ladenburg Thalmann & Co. Inc.

Thanks and just to shift gears a little bit in terms of your internal pipeline. So in your last debate you mentioned another study with was that out in the second quarter of next year. Can you give us a little bit details into what that study would look like and what you are expecting? Can you share what that’s?

Michael S. Anderson

I think I have to – I'm going to let Steve Lisi who you now answer that question, Steve has been intimate with the pipeline and so he can answer that one for you. Steve if you would.

Steven A. Lisi

Sure, thanks Mike. Hey Matt.

Matthew L. Kaplan – Ladenburg Thalmann & Co. Inc.

Hey.

Steven A. Lisi

So if you want to just know what the designing of the data we are going to show later this year correct?

Matthew L. Kaplan – Ladenburg Thalmann & Co. Inc.

Yes.

Steven A. Lisi

Okay. So we did 4.5 gram and 6 gram, earlier we showed you data on that and as Mike stated we were fortunate to get – have the ability to extent the protocol from that first study. So we are going to come back and take the two formulations from the original study since two of them were successful by our criteria and the third didn’t succeed. So we will take those two and anything test them at 4.5 gram, 6 grams and 7.5 grams as well so that will be PK data for those two formulations at all three doses. So this way we can add another dose to what we've studied with our product and we may have one or two PD parameters as well on that. We’ll have to see once we start the study before we are able to include those as well.

Matthew L. Kaplan – Ladenburg Thalmann & Co. Inc.

And then are you going to compare that directly to the approved product in that study or is it just straight as up the Q3?

Steven A. Lisi

Yes, no we are not going approve it, we are not going to compare to the approved product we already did that in the first study, so these two formulations have been compared directly to Xyrem in the first study and there is really no reasons compare it again, these two formulations are exactly the same formulation we used in the first study which is going up to the next dose. So we already have that head-to-head comparison.

Matthew L. Kaplan – Ladenburg Thalmann & Co. Inc.

All right, good and then with respect your LiquiTime programs, could you give us a sense in terms of the timeline both development and potentially NDA filing for this?

Steven A. Lisi

So for our first product we’re looking sure data shortly this quarter, it’s a little bit delayed from mid-year, but we have a lot of projects on going, so a couple of things slips off things down time. So we will see the data this quarter from our first program and we are going move forward if the data are successful or we need to repeat the study to optimize the formulation. We will have to see what the data show.

So in any case we will be moving ahead later this year either with another study or with moving ahead to try to think about scaling up to go into a pivotal study. In any case as you know we still going to have to meet with regulatory authorities both in U.S. and EU to see what is going to be required for approval. If its what we think it is, again we are estimating that we just need bio equivalence and we are not going to need anymore studies than we think that roughly around the end of next year we could file the first product with the second product being six months or six to nine months or so behind that.

Again, we have to speak to the regulatory authorities before we can commit to those timelines. That’s our estimate based upon just bio equivalence being needed with now other information being required from either authority and if they ask us for more, as soon as we find out about that we’ll let you know. So obliviously Matt you know for showing the data this quarter , we are not going to be meeting the regulatory authorities probably until early next year its probably a good bet and if at that time we hear something different we will adjust our timelines.

Operator

Moving on we’ll now go to John Boris with SunTrust.

John T. Boris – SunTrust Robinson Humphrey, Inc.,

Thanks for taking the questions. First question just has to do with Bloxiverz and I apologize if maybe some of these questions were asked, I got on to the floor a little late. Mike in the dialogues that you have had with the FDA on removal of non-NDA approved products. Can you maybe give any color as to what the FDA has communicated to you regarding the removal of non-NDA approved type of products, especially since they listed the shortage band and then just any commentary around VAZCULEP warrant – handing standpoint, just any clarity around the timing of when you would be in a position you would be able to place some product into the trade and then you believe you might be recording some sales on that product. Thanks.

Michael S. Anderson

So John we are briefly discussed earlier, but with respect to Bloxiverz we've had many, many communications. I'm a little hesitant about going into specific details, but I think it would be fair to say that we have – recognizing that this was very important objective for us to have the opportunity to have the only approved drug and the only product on the marketplace, we've been in constant communication with them. We've had what I would describe as positive conversations particularly over the last months or since June and while we talked about a number of issues most of them and I think the FDA’s biggest concern has probably always been our ability to supply the marketplace.

We believe that this action that they did is an indication that they are comfortable that in fact we've been able to prove to them without hesitancy that we have the ability to do that. And we are hopeful then that remain – the last leg of this race if you will is simply the logistics of taking the unapproved products of the marketplace. So that’s unfortunately the best I can say about it. We do feel like that this is going to happen and we do believe that we are at the end of this long pathway.

As it relates to VAZCULEP we anticipate having product in the third quarter and we expect to begin shipping before the end of the third quarter. As you are aware we are the only approved versions on the marketplace with 5 mL and 10 mL pharmacy bulk pack, there is only one other product or one other company out there that has to 5 mL and 10 mL and it is an unapproved products.

So our differentiation if you will its going to be our ability to supply a hospital customer or GPO as case maybe with all three dosage forms that are commonly used. The current breakdown is about 66% of the volume is in the 1 mL and 33% in the pharmacy bulk pack. So they are both good markets just under 50 altogether give or take and we expect this to be a good opportunity as we move forward down the road.

John T. Boris – SunTrust Robinson Humphrey, Inc.

Thanks.

Michael S. Anderson

Sure.

Operator

Next we’ll James Molloy with Summer Street.

James F. Molloy – Summer Street Research Partners

Hey thanks for taking my questions. I was wondering on a bigger picture looking at your development pipeline there was a lot of products and interesting opportunities. How do you guys value it and take internally thinking off, size of the market or the chance you might get the market and how soon you might get the between OTC your Micropump and I will stop there. Just your thoughts form it.

Michael S. Anderson

Yes, well you know I was listening a minute ago when we were talking Steve was describing the pipeline and when we talked about sodium oxybate and these two LiquiTime projects and Trigger Lock and the reality of it is we are a company who has been around for a long time you know, and essentially doing feasibility studies for others.

So for us a company not accustomed to taking products much pass the feasibility stage other than of course Coreg this is a ambitious undertaking and we’ve headed off into this, we’ve been very careful about looking at market opportunities, looking not only at the commercial capability, but then also Jim looking and comparing the commercial capability with the likelihood that we can be technically successful and the likelihood that we can create enough differentiation in the marketplace and that’s a huge issue because you see a lot of things happening, there was a company this week as you know that founded itself on the odd side of two of the big PBMs having their product paid for it.

The bar for giving your product paid for is much higher than it used to be, the old days of just doing an excel form and thinking everybody would run through it, those days are over, they may run through it, but nobody would paid for it. So we've been very careful about taking things like sodium oxybate and taking things like those LiquiTime opportunities and prioritizing them that have a return for our shareholders and validate if you will the technology.

And I think we’re well known the way to doing that. I think it’s quite clear from our perspective that sodium oxybate is a huge opportunity for us, if we can continue to be successful through the development cycle that product – it makes us a very different company down the road and to some degree just our success at the early state its certainly drawn a lot of people’s attention.

So we look in putting all of those tools together, we have a group of people who do that and we’re very careful, because we do have finite resources and we want to make sure we put them in A: places where we can get a return for them and B, projects where we can be successful and so I think you look at things like sodium oxybate and two LiquiTime and Trigger Lock and exenatide project and that’s a lot for a company our size. So it’s going to require us to execute.

James F. Molloy – Summer Street Research Partners

How likely – knowing that Jazz Pharmaceuticals is certainly out there, may well be on this call. How likely are they going to be either through roadblocks to you guys trying to come out with a new product that’s better than theirs?

Michael S. Anderson

Well listen I think that I mean I can’t speak for that companies, we can only look at the market data and we have, look at what we are capable of providing to the health care consumer and make dedications from there. Clearly we look at new product opportunities and we look at other things that are in the pipeline, but we believe that we are on the right track and these are reasonably good opportunities on all of those accounts we talked about. So we don’t have people in other companies, we don’t know exactly what they are interested in doing. Steve you might want to add to that?

Steven A. Lisi

Jim you are right we should realize that the Jazz team is probably listening and I think we know that and we say hello to them, but you know simply current – in the market obviously has a drawback and everybody sees that and I think Jazz sees that as well which is why they have their partnership with Concert and we are going to see that data, they made an announcement a public announcement I don’t know a couple of weeks ago I guess that they are going to be – they have initiated a first-in-man study so we will see that data.

So we really can’t analyze our product against their next generation product until we see data we really don’t know anything and you know if they have a product that’s great, but when we kick this off you know we were looking at Xyrem, right as competition. And I think we feel comfortable about the data that we've seen so far and we've shown to you lets just believe well leads us to believe with conviction that we eliminated the middle of the night dose and we will see some more data at the end of the year, today's the end of this year, so you can see that again hopefully we are consistent with our data.

So from that perspective you know we have a superior product whether we have a superior product to the next generation product they are working with Concert, we can’t analyze that we've seen no data, so we really have no idea. So again, you know I'm Jazz, I'm think well I worked with Concert I knew Flamel was coming, so you know you have got two companies that didn’t know about each other when they started these programs. So that happens all the time in the industry and we will just have to see how it plays out going forward, but I don’t think Jazz is going to stop what they are doing because of what we are doing and vise versa. I think its way too early in the game to know the profiles of – the slow profiles of other products. So let’s just see it unfolds over the next six to 12-montths.

James F. Molloy – Summer Street Research Partners

Great. Thanks for taking the questions.

Michael S. Anderson

Sure.

Operator

And next we’ll go to Scott Henry with Roth Capital.

Scott R Henry – Roth Capital Partners.

Thank you and good morning. A couple of follow-ups on Bloxiverz. For starters did you give a specific revenue number for Bloxiverz sales in the quarter?

Michael S. Anderson

It was 2.2.

Scott R Henry – Roth Capital Partners.

2.2 Okay and…

Michael S. Anderson

But that only includes revenue that we recognized as you know being new, there were sales that aren’t yet have it because of those rules.

Scott R Henry – Roth Capital Partners.

Right and could you talk about how you see markets share today, I guess second quarter market share likely dipped form the first quarter because supply came back in, but you know would you have expected to gain share in third quarter?

Michael S. Anderson

In the third quarter?

Scott R Henry – Roth Capital Partners.

Or do you expect to gain – you have elected to skew in.

Michael S. Anderson

Well as we enter and as we go throughout Q3, we certainly do expect to see more shares, but I think that what you saw was a pretty natural reaction in Q2 and that is in Q1 they had no choice but to buy a more expensive product at times and in Q2 they didn’t have to make that decision and opted to buy the less expensive one. And that’s pretty much what you see with these things if you go back and track all the various ones, and until the FDA moves it’s going to be a little bit up and down. So we are hopeful and come to believe that will be sooner rather than later.

Scott R Henry – Roth Capital Partners.

Okay, when you go out and sell to your customers are you noticing any changes in buying patterns or some of the wholesalers trying to move away from the unapproved products or how are the dynamics if you get any color on that?

Michael S. Anderson

That’s really a good question. And the answer is we have not yet Scott seen any changing and buying patterns and dynamics, but I think once if you look back to historically at these kinds of products, once an announcement is made, in whatever form it may come, I think then you begun to see people immediately begin migrating for several reasons. Number one, there is a liability issue, if you are going out buying an approved product that’s been known to be being taken of the market with a finite day.

Number two, is that customers are concerned that if they don’t in some cases move now they might find themselves on a short end down the road and then we’ve even seen and because in my past I have been on both ends of that. We've even see people return unapproved products. So it’s hard to understand exactly what will happen, but I think that pretty much kind of gives you a feel for it and we would expect that once the FDA acts and how they choose to communicate that will signal a beginning of a much larger change.

Scott R Henry – Roth Capital Partners.

Okay and then final question, is it safe to assume you would not reevaluate the price of this product until you reach kind of a new stabilization of the market with competition no longer there?

Michael S. Anderson

Well, I mean we wouldn’t talk about pricing in advance under any circumstance, but I think that’s an reasonable assumption to make is that we are not in a position today with a 10 or there about percent share of taking additional price.

Scott R Henry – Roth Capital Partners.

Okay, great. Well thank you for taking the questions.

Michael S. Anderson

Thank you.

Operator

Next we’ll Jason Gerberry with Leerink Partners.

Jason M. Gerberry – Leerink Partners LLC

Hi, thanks for taking the question. Just wanted to circle back to Jazz the product that you mentioned that they we are working with Concert on and start their own PK trial shortly. Could you just talk about where you see them in the market, how much further behind you guys do you think they are, do you have any commentary in terms of what you think the technical risks to do the rating deteriorating sodium oxybate might be and then also can you just comment do you think – what we should we be looking for in term of your ability to potentially skip Phase III pivotal trial?

Michael S. Anderson

Right. Steve do you want to finish up on that one?

Steven A. Lisi

Sure. Jason what was that last point about the Phase III trial? I'm sorry I missed that last comment you made toward?

Jason M. Gerberry – Leerink Partners LLC

Yes. Is there any hope that potentially that you guys might be able to skip of Phase III trial.

Steven A. Lisi

No, we are not first of all we are not going – we don’t have bioequivalence that was what we said in the – when we released the first set of results, so we are bioequivalent.

Jason M. Gerberry – Leerink Partners LLC

All right okay.

Steven A. Lisi

We are going to have run a Phase III pivotal efficacy study that’s for sure. The number of patients, what that looks like and all, we need to sit down with the FDA and EMA just talk about what they respectively want from us in a pivotal study. So that’s going to happen, we are just not at that stage yet and so.

Jason M. Gerberry – Leerink Partners LLC

So Steve you will be referencing if it’s a part 505(b)2 application correct?

Steven A. Lisi

That is correct, that is correct. Yes.

Jason M. Gerberry – Leerink Partners LLC

Okay.

Steven A. Lisi

Okay, so you asked about where we think are the timing is with the Jazz and Concert product, I mean we can only go by what’s public information, so the only things we can do is look at other due to rated products that are in the market that are not approved yet as – on my understanding I don’t think there any approved, but there plenty in advanced clinical stages some Phase III programs and if you just look at what’s been required of those companies in their Phase III studies you will see what I would assume would be assume would be required of all these due to rated products unless we get to a point where FDA says “hey we are comfortable with due to rating these products and we don’t need to have such complex and long term studies in Phase III.

I don’t know if we are ever going to get there, but we will see, but right now what we can do is look at what’s available out there and assume that Jazz and Concert are going to follow the same pathway that those who are – or those products that are in front some of them are Concerts as well. So those product that are further advanced, I would assume that Jazz will to follow a path similar to those from a timing perspective, so you can do your own math on those and figure out exactly what they have to do versus what we have to do and you would see that depending on how our data comes out if everything runs smoothly to both company I think we are going be able to submit an application prior to them submitting an application, but again this makes some assumption of data that are publically available for other companies and other programs that are not Jazz so there could be something different about what they are doing and we just don’t know, we have no idea.

Jason M. Gerberry – Leerink Partners LLC

Okay. And then if I could just follow-up quickly, you mentioned some comments in the prepared remarks about the size of phenylephrine market I think I heard 50 million. Is that gross IMS sales or is that net. Can you comment just in terms of how should we think about the current pricing either WAC and then ASP per injectible unit or as captured by IMS.

Michael S. Anderson

Jason those are only reported IMS gross sales which is you know have some limitation with them and we – until we get closer we really wont have any commentary or ability to talk about the pricing, but clearly having gone through this exercise we would expect and have an expectation that we would be able to get a return on our investment and we think there are some opportunities there. So we’ll have to wait and see as we get closer, but yes those are gross IMS numbers.

Jason M. Gerberry – Leerink Partners LLC

Okay, great. Thank you.

Michael S. Anderson

Thank you.

Operator

And that concludes our Q&A session. At this time, I would like to turn it back over to Michael Anderson for any additional or closing remarks.

Michael S. Anderson

Yes, thank you very much. We once again appreciate your joining us on the call this afternoon and we will look forward to updating you again on our business during our third quarter call. Thank you very much and have a great day.

Operator

And that does conclude today’s conference. We thank everyone again for their participation.

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Source: Flamel Technologies' (FLML) CEO Michael Anderson on Q2 2014 Results - Earnings Call Transcript

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