Stephanie Carrington - ICR, Investor Relations Mike Anderson - CEO Sian Crouzet - Principal Financial Officer.

John Boris - Suntrust Robinson Humphrey Jason Gerberry - Leerink Partners Matt Kaplan - Ladenburg Thalmann Jason Butler - JMP Securities Jim Molloy - Laidlaw & Company.

Good morning, ladies and gentlemen and welcome to today's Flamel Technologies' Third Quarter 2015 Results Conference. Just to note that this call is being recorded. And now it's my pleasure to turn the conference over to Stephanie Carrington. Please go ahead..

Good morning and welcome to Flamel Technologies' third quarter 2015 conference call. This is Stephanie Carrington of ICR Investor Relations. Before we begin, I will start with some cautionary statements. The following presentation regarding Flamel Technologies S.A.

includes a number of matters that constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated in such forward-looking statements.

These risks include the risks that products in development stage may not achieve scientific objectives or milestones or meet stringent regulatory requirements, uncertainties regarding market acceptance of products and the impact of competitive products and pricing.

These and other risks are described more fully in Flamel's public filings, including Form 20-F for the year ended December 31, 2014. Except as required by law, Flamel undertakes no 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 will be opening the call to a question-and-answer period. At this time, it is my pleasure to turn the conference over to Mike Anderson, Chief Executive Officer of Flamel Technologies.

Mike?.

Good morning, ladies and gentlemen. As always, we appreciate you're joining us today. I am excited about our company as Flamel continues to make significant progress in a number of commercial and pipeline areas this year.

Today's call will focus on a number of topics, including Bloxiverz sales and developments in the neostigmine market, Vazculep pricing and share during the quarter.

The licensing of our LiquiTime drug delivery platform to Perrigo of the US over the counter market and progress of our pipeline, the proprietary products including Micropump sodium oxybate, Trigger Lock, hydromorphone and LiquiTime for prescription use.

After my remarks, Sian Crouzet, our Principal Financial Officer will discuss our third quarter financials. Flamel's FDA-approved Bloxiverz continue to lead the neostigmine methylsulfate market throughout the third quarter. According to the IMS and Kluwer Wolters, Flamel share averaged approximately 60% of the unit volume supply for the third quarter.

While this share is smaller than the previous quarter, you will recall that we've always anticipated a 50-50 split the market with Fresenius Kabi, who also markets an FDA-approved product. To-date, our market penetration is above where we had expected it to be at this juncture.

However, as was also anticipated in order to maintain share, we have come down marginally on our contracted price.

Which resulted in a slightly lower Bloxiverz revenue of $41.2 million in the third quarter versus approximately $45 million during the second quarter of 2015? From our vantage point, it would appear as if the share changes and pricing have stabilized.

While on the topic of Bloxiverz, we feel like it's pertinent to touch upon Merck's recent advisory committee panel with the FDA for its drug Sugammadex. For which it received a unanimous vote of approval.

As many of you may know, Sugammadex is currently approved in over 50 countries outside the US for the reversal of neuromuscular blockade during and after surgery. We'd like to note that this is not the first time, that Sugammadex has received a unanimous vote from an ADCOM only to be later turned down by the FDA.

In fact, the drug has been rejected two times by the FDA due to concerns regarding hypersensitivity and anaphylaxis. Additionally, Sugammadex is only approximately 10% share combined across all of the markets in which it is approved and it is expected to be priced at a premium to neostigmine.

Given the low adoption in already approved markets and the hypersensitivity risks associated with the product. Flamel does not see this as being overly burdensome in terms of neostigmine market erosion.

We believe that the entrance of a generic version of neostigmine, which we conservatively model entering the market in the second half of 2016, would have a greater impact.

We would like to reiterate that even with the entrance of a third player, the neostigmine market would likely be in the $300 million range providing Flamel, with a substantial tail and continued strong cash flow. Flamel's second FDA-approved Vazculep or phenylephrine injection continued in the third quarter to make gains.

Flamel is the only company supplying FDA approved phenylephrine in all three available vial sizes. The 1 ml, 5 ml and 10 ml. Throughout the quarter, Flamel supplied an average of 94% of the 5 ml market, a 100% of the 10 ml vial size as unapproved product from Sandoz was exhausted in the market. Flamel owned an average of 18% of the 1 ml market.

West-Ward the only other company with an FDA approval on the 1 ml, lowered its contract price on the 1 ml. However, Flamel has decided not to erode price on the 1 ml in pursuit of additional share at this time.

Our sole source status on the 5 ml and 10 ml vial sizes have allowed Flamel to recognize sales of $5.6 million for Vazculep in the third quarter of 2015, an increase of $2 million from the prior quarter.

As planned, the company submitted a new drug application to the FDA for its third unapproved marketed drug, a Éclat 3 if you will in the second quarter and subsequently received notification of its acceptance in the third quarter.

We received a PDUFA date of April 30, 2016 and previously estimated the size of this market at $70 million, which was similar to our initial estimate of the market for Bloxiverz at the time of product launch. We have seen no competitive developments that would lessen the attractiveness of this opportunity for Flamel.

The company does plan to request a period of market exclusivity on this product. However, this decision is at the full discretion of the FDA and we do not expect clarity on this matter until closer to the PDUFA date. While we believe, we would be technically entitled to that exclusivity.

It is unclear that FDA would be willing to award a 5-year exclusive period. Now I want to make another comment, if I might concerning these Éclat products. It's important to remember that these original products from Éclat were never designed to be strategic since there is no IP surrounding them.

They were pursued in order to provide some cash flow, which would then be used to help us develop a more proprietary pipeline, which we would be able to fund on our own. These products have done exactly, what we set out to do at the beginning. Please remember, that these products are means not an ends.

Near the end of the third quarter, our Irish subsidiary, Flamel Ireland Limited licensed exclusive US rights to the LiquiTime drug delivery platform to Perrigo's Irish subsidiary Elan Pharma International Limited for the US over the counter drug market.

LiquiTime of course refers to our proprietary drug delivery technology for extended and control release of liquid oral drugs. Flamel previously guided to completing a LiquiTime deal before the end of the year. And we're excited about the opportunity to partner with Perrigo given its leading position in the OTC market.

As previously outlined, Flamel received a $6 million non-refundable upfront payment and will be eligible for at least $50 million in approval and launch milestones for a minimum of seven products. Flamel will also receive upper single-digit royalties on net sales.

The exclusive license includes LiquiTime ibuprofen and LiquiTime guaifenesin oral suspensions both of which are expected to enter into pivotal trials in the first half of 2016. The OTC cough/cold market is estimated to be in the range of $6.5 billion a year and the need for extended release liquid oral therapies is widely recognized.

Both Flamel and Perrigo believe the commercial potential for monotherapies and combination therapies using our LiquiTime drug delivery platform is robust. Additionally, a large potential market or use of the LiquiTime technology with prescription products exists.

Particularly for pediatrics, geriatrics and patients with dysphagia and other conditions that make swallowing difficult. Flamel retained the rights to develop prescription product using LiquiTime and is actively assessing at this time potential opportunities to employ the technology.

We would likely market those products ourselves as we believe, it would be the best way to capitalize on the value of prescription products, driving significant shareholder value. We are doing initial feasibility studies on several products and will speak to them in due course. Turning to our proprietary Micropump sodium oxybate product.

As previously stated, the company met with the FDA in the second quarter to receive its guidance prior to beginning our pivotal trial for sodium oxybate and we were pleased with the FDA's direction and response.

We are reiterating our timeline and beginning patient screening for enrollment into our pivotal trial by the end of this year, running the pivotal trial in 2016 and filing an NDA around mid-year 2017. Since our meeting the FDA, we have started developing relationships with clinicians and patients in order to expedite the eventual study itself.

We anticipate that this pre-work will serve to accelerate the inclusion of clinical sites and patient enrollment. Interest from investigators comes from both the United States and Europe and we're hopeful that building those relationships will help us to hit the ground more rapidly.

We've also been involved in building clinical trial materials and are on track in that area as well. We will not be offering additional granularity on the study itself at this time, but as it commences additional information will be offered by Flamel and of course, it will be included on clinical trials [indiscernible].

I want to remind you that our objective is not to produce a bioequivalent version of Xyrem, but to produce and demonstrate a better profit, built around the potential of eliminating the second Middle-of-the Night Dose.

Flamel's commitment to this product and our belief that we will ultimately be able to offer greater value to patients positions and payers as is strong today as it ever been. We're striving to dramatically improve the standard of care of these narcolepsy patients.

As announced in the previous quarter, the company showed positive results from two pilots pharmacokinetic studies in healthy volunteers of Flamel Technologies 227, an abuse-deterrent extended release oral hydromorphone product using Flamel's proprietary Trigger Lock drug delivery platform.

The US market for all prescription painkillers in 2014 totaled $9.4 billion. we believe Trigger Lock is a robust platform for opioid's that will set a high standard. In terms of abused-deterrents which is of course a major public health concern.

A company is working to generate independent abuse-deterrent data through a CRO and we expect that data very, very shortly. We will be requesting a meeting with the FDA before the end of the year. We plan to discuss the drug development plan for FT227 and plans to begin pivotal registration studies by mid-2016.

Finally, our last major disclosed proprietary product uses Medusa. Flamel's hydrogel depo delivery system. It is applicable to a wide range of peptides protein drugs and small molecules as well. We expect Phase I data from our First-in-Man study of Medusa Exenatide before year end.

As a reminder, sales of GLP-1 drugs were $3.2 billion in 2014 and they're enjoying healthy growth rates. Two of the primary drugs used in this market are twice daily Byetta and Bydureon once per week form with a significantly larger dose of Active.

The profile we would seek with our Medusa Exenatide product would be to extend the release without the large dose of Exenatide required in Bydureon. While the development timeline for Medusa Exenatide as a biosimilar will take longer than our other products.

The good news is, that the market is very large and growing and Flamel has patent protection on this technology through 2028 in the EU and 2031 in the US. I will now turn the call over to Sian Crouzet to discuss Flamel's financial in further detail.

Sian?.

Thank you, Mike and thank you for joining us today. Flamel reported total revenues during the third quarter of 2015 of $47.3 million compared to $2.9 million in the prior year period. Total revenues were comprised of net sales of Bloxiverz was $41.2 million, Vazculep of $5.6 million and other revenues of $500,000.

Cost of goods and services sold for the third quarter, 2015 were $2.1 million compared to $707,000 in the third quarter of 2014. Research and development costs during the third quarter, 2015 totaled $7.2 million compared to $4.1 million in the prior year period.

A substantial portion of increased R&D spending was attributed to continued investment in the company's pipeline and other proprietary products. Selling general and administrative costs totaled $4.6 million in the third quarter of 2015 compared to $4 million in the prior year period.

The increase in SG&A resulted from increased stock compensation expense due to a higher stock price at the time of grant. We continue amortize R&D asset associated with the development of Bloxiverz and Vazculep. The amortization expense was $3.1 million in the third quarter, 2015 consistent with prior quarters.

Net loss from continuing operations for the third quarter 2015 was $29.7 million versus a net loss of $10 million in the year ago period. Loss per diluted share from continuing operations was $0.73 in the third quarter of 2015, versus loss per diluted share from continuing operations of $0.26 in the third quarter of 2014.

The increase in that loss from continuing operations, when compared to the same period last year. Primarily resulted from higher charges associated with fair value re-measurements of certain acquisitions on royalty liabilities, which increased by $36.9 million and $5.2 million respectively.

And a decrease in foreign exchange gain as $7.9 million from the third quarter, 2014 that did not repeat in the third quarter of 2015. The aforementioned liabilities were incurred as a part of Flamel's acquisition of Éclat Pharmaceuticals in March, 2012 and debt financing in 2013.

And the tie to commercial sales of FDA approved products as well as other factors, which are described in the Form 20-F filing. In addition, we have provided certain non-GAAP that allows investors to evaluate the company's ongoing operations.

The adjustments exclude fair value re-measurements and amortization expense directly associated with the acquisition of Éclat on an after-tax basis, exclude asset impairment effects of early reinvestments of certain debt instruments and unrealized foreign exchange gains and losses.

As it includes, earn-out royalty payments due associated with the acquisition liabilities and royalty agreement. Adjusted net income for the third quarter of 2015 was $11.5 million compared to an adjusted net loss of $6 million in the third quarter of 2014.

Adjusted earnings per share were $0.28 in the third quarter of 2015 compared to a loss per share of $0.16 in the prior year period.

For the nine months period ended September 30, the company has an adjusted net income of $29.2 million and adjusted earnings per share of $0.72 compared to an adjusted net loss of $15.6 million and an adjusted loss per share of $0.44 in the prior year.

The company's cash position as of September 30, 2015 was $128.4 million compared to $116.1 million as of June 30, 2015.

Our effective tax rate for the third quarter 2015 was 37.1%, which reflects the - tax rates in jurisdictions where our taxable income is generated with near term revenue streams being generated essentially in the US from Bloxiverz and Vazculep. While our R&D expenditure is essentially in Europe.

This rate is lower than what we initially expected for the quarter and the company continues its efforts to lower our effective tax rate. With that, I will now turn the call back to Mike before taking questions.

Mike?.

Thank you, Sian. That being said, we've taken actions in anticipation of being profitable obviously in 2015 and beyond. We continue to strengthen our organization having filled out additional members of the management team.

We have completed our first deal through Flamel Ireland and efforts through capitalize on adjusting and more advantageous tax structure and look forward to adapt lower tax structure on our third UMD product as well, which was also filed through Flamel Ireland upon launch in 2016.

In Summary, Flamel continues to grow and is generating meaningful sales and profits.

We will continue to focus on advancing our product development pipeline by exploring the potential use of LiquiTime for prescription use enrollment in our pivotal trial for Micropump sodium oxybate and we look forward to announcing data from the Medusa Exenatide Phase I clinical trial at end of the year, as well.

As another reminder, we have achieved 100% of our growth over the past year through organic initiatives. We've created shareholder value by opportunistically pursuing our UMD strategy and have demonstrated our ability to strategically advance our pipeline by licensing our LiquiTime technology.

Flamel's solid cash flow from operations and lack of debt put the company in a strong position to leverage our balance sheet and for the first time, we've begun to explore expansion through a strategic acquisition of assets and or commercial infrastructure.

We've said since the beginning, that we're interested in creating a company that's capable of supporting itself in every manner. We've indicated a strong interest in establishing a commercial footprint.

The company is looking at a number of potential opportunities that we believe would be both previous and or complementary to our current portfolio of products. A product or small infrastructure that would allow us to begin that process and provide a platform for some of our new products would be ideal.

Make no mistake of our expertise and experience in creating these types of platforms. Finally, I'd like to make a comment about the recent turmoil in the market and the impact on the value of Flamel's stock price. In our view, this impact has been impart in association with the Biotech/Speciality pharma space in general.

And as further exacerbated by the current political discussion on pharmaceutical pricing. We believe, our strategic decisions on pricing are radically different than those described to other companies and they're not an integral part of our strategy at Flamel.

Our plan here was to fund the development and approval of products and then to create a situation, where our investors could earn a return on their investment. We have invested in the development and approval of products not previously approved by the FDA, which creates value for patients.

Additionally, we don't use speciality pharmacies or controlled networks as some in the industry have done. More recently, our stock may have been impacted by the FDA's ADCOM meeting regarding Sugammadex. Again the immediate impact to Flamel should the product be approved at all. In our view is manageable.

We believe the strategic direction that we have set is both sound and achievable even in turbulent markets. As you look back on Flamel over the past months, you can see a company that's articulated objectives and then achieve them. We said we would file the third NDA, we did so and now have an April, PDUFA date.

We said, we expected to out-license our LiquiTime, OTC projects before year end and we did. We said, we would be strengthening our management team and we have. We believe, our strategic pathway is appropriate and that we're executing against it. We would hope that investors judge Flamel by our achievements and not by other measures.

Our model is focused on addressing the changing paradigms the pharmaceutical market relative to reimbursement requirements. We remained focused on executing the game plan we've outlined and we're on track.

This is an exciting time for the company and we look forward to providing updates throughout the coming quarters as Flamel continues its mission of building a strong speciality pharma company with outstanding drug delivery capabilities. We appreciate your participation on today's call and with that, we will take your questions.

Operator?.

[Operator Instructions] and we will go first to John Boris at Suntrust..

Just want to start off with a couple of quick accounting question. First question just has to do with why your tax expense for the full year 2015 is greater than your adjusted net income that you reported in 2015.

And then second question related to tax also is on - how should we be thinking about the effective tax rate that will lead to tax effect that relative to the tax rate we should be using on Bloxiverz and Vazculep?.

John, I'm going to, Sian if you could answer those questions? Sian, has the information right in front of her, John..

Okay, so the first question. I think was understanding how the accumulated tax expense could be could be higher than accumulated adjusted net income. I think as you mentioned in some of the prepared remarks we have, revenues in one jurisdictions and costs in the other jurisdictions.

Given the imbalance between the revenue generation and expense generation.

We're not getting the deductibility of the expenses in Europe with the revenue generation in the US, which is why you get to the situation you can see between the adjusted net income compared to the tax expense, does that explain you the situation?.

Not fully..

Okay, so all of your revenues in the US are pretty much taxable. We've used up all our bought forward losses and our costs are in Europe on which we're not getting any tax release at this stage..

Okay, effective tax rate on the Éclat 3?.

So going forward looking at, Éclat 3 as we've mentioned, we've filed Éclat 3 from Ireland. As such, we expect to benefit to a certain degree of the tax rate available to us in Ireland. We expect to have a 12.5% rate in Ireland on certain portion of those revenues, it should be understood but some of the development of that product did occur in the US.

So there's going to be some apportionment required..

John, let me add to that. We're taking this asset, some of which we've articulated, some of which we've not to establish a more attractive tax platform and part of that is, what we've done in building out our infrastructure in Ireland.

So we're going to continue to move that forward over the course over the next number of months and as we had previously described, we will, we think you'll see that tax rate continue to decline..

That's great. One last question, if I may be for hopping back in the queue. Just on the sodium oxybate program. Can you just maybe discuss clinical supplies, obviously there is a lot of bulk active that you would have to put together for a clinical trials that you're conducting.

Do you have enough bulk active or clinical supplies to roll out the trial?.

Yes, we believe we're in good shape. We've obviously as you know because of the unusual nature of sodium oxybate the supply chain for sodium oxybate is quite unique and it's raw form, it's a Schedule I drug ultimately becomes Schedule III.

So the answer to your question is, we're comfortable with our clinical trial supplies and ability to keep those going all throughout the course of not only the commencement of the study, but throughout the year as well. And we will obviously be doing some of those trials in Europe as well as in the US.

So anyway, I think the answer to your question is we're very comfortable with where we sit, with respect to our ability to provide clinical trials and sufficient quantity, even in spite of the unusual supply chain..

Great, thanks for taking the questions..

We will go next to Jason Gerberry at Leerink Partners.

This is Derek on for Jason, thanks for taking my question. First, it seems like you're running around $25 million to $30 million in R&D for 2015.

So how should we start thinking about R&D for 2016 as you initiate some of these clinical trial and then my second question on the Trigger Lock program I guess you haven't had a meeting with the FDA at how do you envision labeling will compare to some of the recently approved products from Caligem [ph] and Inspirion [ph] and carry on and may be can talk about some of the differentiating factor between the trigger Lock platform versus some of the other 80 platforms out there.

Thanks..

Right, so your first question with related to the use. I mean, well let's take your second question, first. As it relates to R&D expense which was your first question. The R&D expenditures on the so far through three quarters of 2015 or lighter than they will be not only. I mean certainly for 2016.

Obviously as we get into more depth with association with the sodium oxybate trial, Hydromorphone trial, those expenditures will go up. Somewhat dramatically over the course of next year.

We haven't articulated what that will be now, but I think that you shouldn't look at what we spend in third quarter as being indicative, what's spend in the fourth quarter will be or the spend in 2016 as we engage those trials.

We'll also be doing, some of the work and we're responsible for some of the work associated with guaifenesin and ibuprofen as well. So the R&D expenditure will go up over the course of next year.

And that, does that sufficiently answer what you were looking for?.

Yes, thanks Mike..

Oka, so Derek, as it relates to Trigger Lock.

We'll be sitting down with the FDA, we have in our previously we've discussed having been able to show internally the ability to provide a good abuse resistance with respect to crushing and snorting and the use of the drug with alcohol and we're going, we're in the process of finalizing and we should have results sometime fairly quickly or an independent confirmation through a CRO of those same studies.

And while we don't have all data together, initially it looks pretty promising. So we'll sit down, obviously Trigger Lock is a mechanism which we're using nano and microparticles.

And it's a specialized coding process that allows you to produce a product that is so finite and small that it can't be crushed or snorted and you can adjust that anyway, through the use of the coding and how you apply. Each of the nano and microparticles are coded with a separate very different release rate.

So we've already shown the ability to get the PK results we need as you know and so this will be our first meeting with this product, with FDA to file that. For the IMD [ph] meeting to make sure that we're on track with what they want, the rest of the way with respect to abuse-deterrents.

The real objective and the real issue I think today with abuse-deterrents the requirement if you do likability studies. And at the end of the day, that's pretty much what the ultimate measure will be.

Interesting thing about the abuse-deterrent opioid market is that, you have a limited number of drugs that actually fit into that space and you have a lot of people chasing them as you know.

What we would hope to do is, come away with a clear understanding from FDA as to what their expectation will be and then begin that development process all the while beginning to look for a licensing partner. And that process has already begun and we'll continue that throughout the course of next year and in the coming days.

We'll talk about expectations of attempting to license the rights of Trigger Lock or the entire opioid market to potentially one licensee. We'll have more on that on later as we get further down the road and we have a FDA meeting..

Great, thanks Mike..

We'll go next to Matt Kaplan at Ladenburg Thalmann.

Couple questions, Mike. In your prepared remarks, you may have mentioned something on Bloxiverz pricing and a reduction of price.

Can you give us a little bit more detail on where the pricing is now and where it was before?.

Yes, so what we really talked to Matt or the really gross to net numbers. And last quarter we were talking about them in the terms of 65% range. I think we're lower than that now, gross to net somewhere around 60% and some of that, so we gave up.

And that was because as you know we've lost of little share some we protected, some we've chosen not to protect. So that's kind of little bit of the story. There's another component to the numbers for the third quarter and it talks about the mix and specifically the mix involving 340B patients.

I think everybody is pretty much familiar 340B program and the 340B where we've been a participant carries with penalty, when you have price increases that are above the consumer price index and inflation rates.

And over the course of the third quarter and because of the way the program works, we saw and I guess I would call that an increase number of patients on the 340B program. We've taken steps, you can't do it immediately but during the course of Q3, we took steps to eliminate that component.

I mean the penalty is for people to increase the price and you recall that in January, we had a significant price increase. The penalties there pretty robust for that program. So we're still - our product is still available for 340B patients, but it's done through a prime vendor instead of the program itself.

So the disproportionate number of sales through the 340B program that we saw in Q3 will not exist in Q4. We believe that in Q4 from everything that we can see to-date, pricing is very stable and the shares seem to be stable as well. So I hope that answers your questions. It was a combination of three things.

Natural market conditions because it is a duopoly which we think have settled out and our disproportionate share of 340B market place.

You're probably aware there have been, there are some investigations ongoing about the 340B program and some of the abuse that's taking place in the programs and you know, we're not that has nothing to do with us but the programs themselves at some point will need some adjustment..

Okay, thank you for the detail. It's helpful. and can you talk a little bit about the Éclat 3 and its potential in the marketplace and I guess in terms of and I guess, specifically what you're thinking in 2016 as you, after potential approval in late April..

Well, we haven't prescribed the drug obviously for competitive reasons. It's not in the best interest of our shareholders to do that. So we're going to play this thing pretty close to the vest, until such times we get an approval and we can get the product into the marketplace.

We've described previously, when we first announced the acceptance of the application and the PDUFA date, we announced it and talked about it, it's being about $70 million market. Which was, we compared to what the Bloxiverz opportunity was, when we started that. And the reality, so market's changed from time-to-time.

So there could be adjustments, it could become more valuable, less valuable it just depends on what happens but I think that we've seen nothing and we feel pretty good about the opportunity and as we get closer and as we do it, we'll update that. To do so now, would in my view be a little bit premature.

Since we still have several months to go before the PDUFA But we look at it Matt as a good opportunity for the company.

Obviously, if we were to be successful getting any kind of exclusivity it's even more attractive, as a handicap, where I personally think that's a small - chance that will take place, but nevertheless, we're going to make every effort to do that..

I guess, what I was trying to get at is, in terms of the dynamic of potential for removal of the unapproved products by FDA's - market is this going to take, is it an 18 months period or is it a 12 month period or is it six month period or something like that?.

Well, that's a reasonable question. So Bloxiverz which took us over a year to get the FDA to respond. Was impacted by two market dynamics that don't exists today. Number one was that, Neostigmine has always been regarded about the FDA officially as a medically necessary drug.

So they were always very sensitized to making sure that a medically necessary drug is available for patients.

The second thing that was is that, in the 18 months two years prior to our approval, Neostigmine had been in short supply as you know and so I think the combination of those two things was such that FDA took longer and said that we're concerned about taking people who at least they knew pulling them off of the market then turning the entire market of a medically necessary drug over to an Éclat Pharmaceuticals, who nobody knew.

And I think over the course of that year, once they've finally made the decision and the players who were in it left the marketplace. I think the FDA came to have a better understanding about Éclat.

I think they came to have a great confidence and comfort level, that we could supply the market place and our hope and expectation is that, will serve us when we go within Éclat #3. And we'll make every effort to point those out.

We'll start to work before that, to paint the picture with FDA and I would once again remind you, that this is their program. We believe that by doing this, we're doing the healthcare consumer and the FDA a favour. We're taking a drug is never been approved, we're doing the work, paying the user fee and getting it approved.

And we think that, given our track record with our existing products that when it comes to this third one, that the FDA will have a much better feel for, who we are and our ability to supply the market. So at the end of the day, though Matt, we don't know..

Okay, fair enough. Thank you. And then last question, is in terms of sodium oxybate. The IP I guess battles that are going out there with Xyrem and generic [ph] right now.

What are your plans there and how does your sodium oxybate stack up?.

Right, well obviously there is IP landscape surrounding it. There's competition matter of patents which we think are irrelevant in our case. Those patents surround all talk about Xyrem being an aqueous solution. Ours as you know is powder and it's different. But the real obstacle probably for us today are surround the rims.

And the rims of course is being bought, a real different venues [ph]. But today, and we don't really know how that will ultimately end up.

But I would remind you, that our objective with our sodium oxybate is to build a product that's not bioequivalent to Xyrem, but one that has significant advantages and part of what those advantages could be the safety issue. So there is absolutely no guarantee that the FDA would require us to do the same rims.

If our product shows up in our view and others to be a safer iteration of sodium oxybate, then we'll try to argue that it doesn't require the same rims and we'll do that.

One thing is for sure is, whatever when we get there and we bought this drug in some kind of mid-17 and hope theoretically we'll have to certify against one of our patents exists out there. That whatever they look like today will be different than what they look like then.

So we'll have to see, but hopefully we'll and FDA has said is that, there is no requirement. I mean they have the ability to change the rim. A lot of different things could happen. I for one, don't believe FDA would hold back or would make some sort of allowances for product that they deem to be safer at the end of the day, if that's what we can prove.

So we'll have to address it at the time, but we feel pretty comfortable. We've already started working on all those things. Well so we're not going to wait till the 12th hour to begin working on it..

Right, thanks for taking my questions..

We'll go next to Jason Butler at JMP Securities.

First one, just on the Bloxiverz market.

Could you just speak generally about what you saw in the overall volumes for the Neostigmine market in 3Q and so far in 2015?.

Yes, so actually that's a great question, Jason. So what we - if you look at the data from both Wolters Kluwer and you look at IMS data. It looks as if the market place which for a period of time, in the earlier part of 2015 is beginning to come back and even looking even just at IMS vials for the course of the third quarter, they were the highest.

They've been over the course of the year. Earlier in the year, there were some conjuncture, while this [ph] market going away and really it's not.

What wasn't visible to people at the time was that last October and September when the after the FDA had mandated that the unapproved guys Kabi and West-Ward leave the marketplace are not be able to manufacture. In September and October of 2014, there were 1.5 million vials sold into the marketplace.

And that merchandise, those files were pretty quickly went out of the wholesale channel and under the hospital shelf. So when we got to about January and we saw supply drying up.

We said, well the market place is empty and the wholesaler was, but on the hospital shelf these guys had bought in some cases six months to eight months’ work predicated upon the dating.

The long and short of it is that, the market play seems to be consistent over a period of years and there's been no changes here in fact the July, August and September period particularly September is back to is still in the neighbourhood of 5 million, 4.8 million to 5.2 million vials over the last number of years.

And there appears to be no change in that..

Okay, great. That's helpful and then just on Vazculep. Can you help us think about the future growth or trajectory of the project? I mean, you have essentially 100% market share of the 5 ml and 10 ml vials.

Do you think that the 1 ml vial now both in terms of market share and price is stable or could we see either growth or erosion of either and just in general, help us think about the directionality of Vazculep over the next few quarters?.

Well, so I think we've obviously, we've continued to grow over the course of this year our 5 ml and 10 ml share, we are at 100% now and those will remain consistent. And I don't see any particular growth in it, I don't see any change in the pricing given that they're kind of directed and have to be tied to the 1 ml.

Remember that the 5 ml and the 10 ml are used for slightly different purpose. Typically they're put into bags and used for preventive purposes. Whereas the 1 ml which are 66% of the units, the 1 ml vial size is kind of thought to be a rescue drug. So the pricing that we can muster for the 5 ml and the 10 ml is kind of directly related to the 1 ml.

You can't have a disproportionate. We have seen earlier in the year with a competitor who as you know, it's West-Ward, we had seen even before we got in there, some price decline for a while, but it seems to be fairly stable now and if you'll notice, we're picking up share. We picked up all the 5 ml and the 10 ml of course by default.

And we're now beginning to nibble away at the 1 ml. But we've chosen to match price if you will. With the idea in mind, that if we can pick up share more slowly by maintaining gross margin that's what we would like to do. So we're going to continue that ploy.

We think it's working, it's beginning to work, we continue to pick up new business even on the 1 ml and I see nothing in the marketplace today that I could call out that would have a seasonally differently about it..

Okay, great. Thanks for taking the questions..

And we'll go next to Jim Molloy at Laidlaw.

I was just wondering, one of things you talked about in the past. I mean you highlighted some management that you brought in.

Can you talk little bit about which management you did bring in and what's the story latest for the CFO hiring?.

Good question, thanks Jim. First of all, yes. In the third quarter in some of the, we've issued press releases and have communicated in that way, others we've not.

But typically since the third quarter began we've hired a very expert right in the beginning of the quarter, a Global Vice President responsible for quality, all across the corporation, which means three sites.

France, Ireland and the US and her name is Sandy Hatten and Sandy has excellent history and great reputation in the industry and she's already made meaningful contribution. So we've shown up and hired some staff to surrounding Sandy that relate to both regulatory and quality.

We also hired in the third quarter, a guy named Darren D'Silva [ph] and Darren has also significant pharmaceutical experience. He was both recently was with NPS [ph], he lived in Ireland and he is the Vice President for our Irish and European Operations.

He has a great understanding and experience in helping companies, who are in the process of moving, a lot of their operations to Ireland. He's had a significant experience doing that. And Darren [ph] has also begun to make significant contributions. We hired a guy in the third quarter by the name of Greg Davis.

Greg has a great experience in the business. He was in the equity market for a while. He spent I think 10 years at GSK. He's got roller decks of pharmaceutical contacts that's pretty impressive and he's already been out contacting.

He's a well [indiscernible] off and has shown a lot of expertise and we're going look to Greg to help us grow this business in different ways than we've grown it in the past.

And more recently and while we've not issued an announcement, we've hired a Vice President of Strategic Marketing that's a guy by the name of Steve Sullivan and he's most recently been at Sunovion and he will be working with us here and responsible for helping us to continue to qualify our pipeline as well as to evaluate other opportunities, if they come our way and we may look at over a period of time.

And in terms of our financial organization, we've talked about the needs to beef that up and I think we will have an announcements to make very, very shortly as this some enhancements in that area given where the company is today and some expertise. We just didn't have in the past that we will soon have. So you'll stay tune for that.

Anyway, we've beefed it up. We were told by investors that we needed to do that. We agreed and we've done it in organized fashion and we have a very good team all working together. Hopefully, that answers your questions..

Does indeed. Thank you. Then maybe some quick few on clarity on the pipeline. So the FDA meeting will be, your request the FDA meeting for Trigger Lock fourth quarter, should we expect that meeting will happen first quarter.

Then on Micropump, any additional detail and you guys had that meeting in your on track to sort of Phase III, any additional details from that meeting that you can share and then, on the Medusa.

You're again on track for Phase I data fourth quarter, how soon thereafter can you start the Phase II?.

Yes, when we get the data and we analyze. I'm starting with Medusa. We'll make the decision then we'll - and assuming the data will look like we expect it too, we would likely began that space to sometime in the first quarter of 2016.

In terms of hydromorphone, we're going to be requesting the meeting eminently here, but likelihood is, we won't get into the FDA until hopefully first quarter of 2016. We know that, the vision obviously having in front of them several products over the time.

It kind of depends on just how backed up they're but I would think, first quarter of 2016 is reasonable. And we're probably at this point not going to share additional information on oxybate until we get fully started into the program and then we will try to be more communicative.

I don't know that you should expect to see a press release every time we dose a patient, but we will do our best to keep people abreast of the progress and what we're trying to do and we'll provide more granularity beginning in 2016..

Great, thanks.

The final question then, if I could? Is the execution for Éclat # 3, you won't reveal what it is, until it gets approved and then Éclat # 4 something that's still going to happen, you think?.

I wouldn't be surprised, but we haven't had any more to say about it recently. I think we've said in the past, this is an interesting market. If you looked at total number of drugs that are unapproved to-date, that could withstand an FDA approval some could, some couldn't. They're probably aren't more than dozen that you would look at.

Some of the ones that we originally did the markets have changed. And they don't represent the same opportunity, some of those washed out early.

But we're still continuing to look at that and I wouldn't leave you with impression, that we wouldn't consider doing one, if we found the right one to do product that we thought, we could, it was approvable because it's still relevant or viable or efficacious in FDA's mind and so yes, we're continuing to look at this list.

I wouldn't want you to rule out the possibility that we could do another certainly done pretty well by us. So we'll keep you posted..

Great..

At this time. I would like to turn the program back to Mr. Anderson for any additional or concluding remarks..

Well, once again thank you very much for joining us on this call today and we'll certainly look forward to updating you on our continued progress as we move throughout the remainder of this year and into 2016. Thank you very much and have a great day..

Ladies and gentlemen, once again that does conclude today's conference. And again, I'd like thank everyone for joining us today..