Bob Yedid - ICR Investor Relations Mike Anderson - Chief Executive Officer Siân Crouzet - Principal Financial Officer.
John Boris - SunTrust Derek Archila - Leerink Partners Jim Molloy - Summer Street Matt Kaplan - Ladenburg Thalmann Scott Henry - ROTH Capital.
Please standby, we are about to begin. Good morning, ladies and gentlemen. And welcome to the Flamel Technologies Fourth Quarter 2014 Results Conference Call. Please note that this call is being recorded. Now, I’d like to turn the call over to Mr. Bob Yedid of Investor Relations. Please go ahead, sir..
Good morning. And welcome to the Flamel Technologies fourth 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 SA 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 risks that products in the development stage may not achieve scientific objectives or milestones, or meet stringent regulatory requirements, uncertainties regarding the market acceptance of products, and the impact of competitive products and pricing.
These and other risks are more fully -- 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 takes no obligation to update or revise any forward-looking statements contained in the 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's my pleasure to turn the conference over to Mike Anderson, Chief Executive Officer of Flamel Technologies.
Mike?.
Good morning, ladies and gentlemen. Thank you very much for joining us today. I'm excited about our company and pleased to report that Flamel has made significant progress in a number of commercial and pipeline areas.
In just over one year, we have launched Bloxiverz and Vazculep, presented positive clinical data for Micropump Sodium Oxybate, LiquiTime Ibuprofen and Medusa Exenatide, divested our contract manufacturing facility, so that we can focus on proprietary product development and successfully move our intangibles assets, including intellectual property and other assets to our Irish entity as part of a global reorganization after having established operations in Ireland in 2014.
I’ll focus my remarks on a number of topics today, including Bloxiverz sales and developments in the neostigmine market, Vazculep’s continued success and market share gains post-launch, progress of our pipeline of proprietary products, including Micropump Sodium Oxybate and LiquiTime Ibuprofen, and the status of our other proprietary drugs in our pipeline.
After my remarks, Siân Crouzet, our Principal Financial Officer will discuss our fourth quarter financials. We are excited that during the fourth quarter Bloxiverz was able to continue gaining market share as manufactures of unapproved neostigmines were ordered by the FDA to cease manufacturing of their products as of July 30, 2014.
By our estimates those unapproved products were exhausted in the channel in January and early February 2015. Flamel is pleased to report that we were supplying 100% of the market demand to wholesalers and GPOs by the end of February according to prescription data sources.
As you know, we increased our wholesale acquisition costs or WAC price for Bloxiverz from $35.80 to $98.75 in mid-January, and as of mid-February, we have been shipping at the increased contract price to all customers.
Despite the anticipated entrance of another branded competitor in the neostigmine market in the second quarter, our price action will allow Flamel and its shareholders to enjoy and earn an attractive return on our substantial investment in Bloxiverz.
The investments included the cost of preparing and submitting the NDA filing, obtaining FDA approval, fulfilling our post-marketing commitments to the agency and building substantial inventories of Bloxiverz to demonstrate to the FDA that Flamel was capable of supplying 100% of the markets needs.
This was done to persuade the agency to take regulatory action against unapproved manufacturers as per its own guidance.
Flamel’s price increase for Bloxiverz will allow us to capitalize on our advantages decision as the sole supplier of neostigmine today and we are affirming our previous guidance for 2015 product sales of $170 million to $185 million in total for both Bloxiverz and Vazculep.
It is important to note that a few equity research analysts following Flamel have reported that this anticipated supplier of neostigmine has recently announced a flack just $1 to $2 below ours and that this company is anticipated to begin shipping in April. Now let’s turn to Vazculep, our second FDA approved product.
We are pleased that Vazculep continues to gain ground in the phenylephrine market in all three of our vial sizes. We are holding the majority of the market share in the 10 ml product and continued to seek gains in the 5mL market ahead of our expectations.
Although we currently share the 1mL market with another competitor, we are seeing an uptick in this offering as well. Flamel had regular communication with the FDA about following its own regulatory policy with our first product and will follow that same pathway with Vazculep. To remind you, Vazculep was approved on June 30, 2014.
Based on our track record with the agency, we are hopeful that the FDA will act to remove the unapproved manufacture of the 5mL and the 10mL versions of phenylephrine from the market place more quickly than the 14 months it took the agency to act on neostigmine.
Regarding our third unapproved marketed drug, we anticipate our NDA application will be filed in Q2 of 2015. At the time of the acceptance by the filing of the FDA, which takes up to 74 days after the actual filing, Flamel will make an announcement to investors.
We anticipate the initial market size of this opportunity as approximately $70 million which was similar to our initial estimate of the block market for Bloxiverz at the time of the product launch. We will not disclose the chemical entity that we’re working on because frankly doing so would be disadvantageous to the company and to our shareholders.
However, we have seen no development in terms of the targeted market or NDA approvals for this unapproved drug that would lessen relative attractiveness of this opportunity for Flamel.
Turning to our pipeline products, we were thrilled to report in the fourth quarter that the company received positive data for its second-in-man study for Sodium Oxybate, using our proprietary Micropump technology. As you know, Sodium Oxybate is used for narcolepsy patients.
This second trial achieved the objective of the single dose of Sodium Oxybate before bedtime for patients and reconfirmed the results of our previous first-in-man study. The trial was designed as a two-arm study with 12 patients in each arm evaluating two different formulations of Micropump Sodium Oxybate at a nightly dose of 4.5, 6 and 7.5 grams.
As you may know, the current standard of care, Xyrem, is typically divided into two equal doses, the first taken at bedtime and the second dose taken 2.5 to 4 hours later for a total of 4.5 grams.
Flamel’s singular dose of Micropump Sodium Oxybate at both 4.5 grams and 6 grams achieved a similar onset of action to 4.5 grams of Xyrem, a lower Cmax than Xyrem and an average blood concentration at hours 7 to 8 similar to Xyrem.
The data at the 7.5 gram dose for both formulations were consistent with our expectations given the data generated at lower doses. Today Micropump Sodium Oxybate has been tested in 40 healthy subjects across three doses with three different formulations and there were no safety or tolerability issues.
The elimination of the second middle-of-the-night dose would dramatically improve the standard of care for narcolepsy patients. We think it is important to put these two trials into perspective for investors.
Going back to the highly successful companies in their early drug delivery space such as Alza and Elan, clinical data from two first-in-man clinical trials, the alternative delivery forms of known drug compounds was often viewed by drug researchers and investors as a strong indication that the drug would likely be successful in larger clinical trials.
For Flamel, our objective is to meet with the FDA in the second quarter to discuss the pivotal trial program depending upon the outcome of that meeting we anticipate starting a pivotal trial in late 2015 and filing an NDA in the first half of 2017. Now, let’s turn to LiquiTime, Flamel’s platform technology for extended release liquids.
As a reminder, LiquiTime refers to a 12-hour extended release liquid which we believe will be very attractive to consumers in the OTC market, particularly when compared to liquids in remediate release and have to be dosed every four to six hours.
Additionally, there’s a large potential market for prescription products, particularly for pediatrics, geriatrics, patients with dysphagia. In late 2014, the company’s formulation of LiquiTime Ibuprofen, achieved the FDA’s requirements for bioequivalence.
We will be starting a pivotal trial for LiquiTime Ibuprofen in the second half of 2015 and the pivotal trial data will be reported at the end of the year. In addition, we are on track to announce data from a second study of LiquiTime guaifenesin, a widely used expectorant in the second quarter.
The data from our study of LiquiTime guaifenesin is important in moving forward to provide an information package to potential partners for a licensing agreement with Flamel for our LiquiTime technology as applied to ibuprofen, guaifenesin and potentially other products to be marketed as over-the-counter or as we know them OTC drugs.
In addition to both LiquiTime Ibuprofen and LiquiTime guaifenesin as monotherapies, there exists a very large two and three drug combination market in the OTC cough cold arena. We plan to work with partners in that area.
We believe our LiquiTime technology may be able to deliver these multiple drug combinations in a stable form and we would plan on doing this clinical work with a partner. The OTC market for our LiquiTime products is a substantial exciting opportunity for Flamel and a potential partner. The global cough cold market for example exceeds $6.5 billion.
Within the OTC paying market, the U.S. sales for oral suspension ibuprofen, a premium priced product exceeded $200 million in 2014 alone and we believe that the international market is at least twice as large. The market for combination products containing ibuprofen is also large at over $200 million in 2014 in U.S. alone.
Given the size of the OTC market, Flamel is seeking a potential partner to develop and market a full line of OTC products. The likely partners include Global OTC players that are part of either large pharma and/or consumer products companies. Although partnerships are complex, our objective is to partner these products before the end of 2015.
Turning to our other proprietary pipeline products, 2015 should prove to be another exciting year for Flamel.
In addition to data from our LiquiTime guaifenesin study and pivotal data from a LiquiTime ibuprofen trial, the company is also on track to receive human data in the second quarter from our study of Trigger Lock formulations, which are used for abuse deterrents of long acting opioids.
Our historical clinical experience with long acting opioids makes us very excited about seeing this data. Trigger Lock contains sustained release Micropump-based micro particles that are resistant to crushing and extraction. The U.S. market for opioids is large and over $7 billion in 2013.
Abuse of these drugs, as you are no doubt aware, is a major health concern with estimated 2.1 million people in the U.S. suffering from substance abuse of prescription opioids. Finally, the company also expects human data for our study of Medusa exenatide before year end.
Sales of GLP-1 drugs are expected to exceed $3 billion in 2014 and are enjoying healthy growth rates. Two of the primary drugs used in this market are twice daily Byetta and Bydureon, a once a week form with a significantly larger dose.
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 today. The recent FDA approval of Saxenda, a branded form of Novo’s liraglutide for the treatment of obesity could significantly increase the potential market size for GLP-1 drugs.
While Medusa exenatide is a biosimilar that will take longer to develop, the good news is that the market is very large and growing and Flamel has patent protection on this drug through 2027 in the EU and 2031 in the U.S. Overall, the company had an extremely successful year.
Flamel has achieved numerous milestones and by divesting our contract manufacturing facility and having our intangible assets on our proprietary technology housed in Ireland, we have reorganized the company to maximize our focus on product development and on profit generation in 2015 and beyond.
I will now turn the call over to Siân Crouzet to discuss Flamel’s financials in further detail.
Siân?.
Thank you, Mike. And thank you all for joining us today. To start my discussion of the financials, we would like to remind investors that Flamel started development and manufacturing facility located in Pessac, France to Recipharm AB on December 1, 2014.
Under the agreement, Recipharm paid Flamel €10.6 million and also made an investment of €10.5 million in Flamel stock. The license and research services revenues and other revenues related to that facility will be classified as discontinued operations for the three months and 12 months period ended December 31, 2014 and 2013.
The remaining data I will be discussing today will address only our results from continuing operations.
For the benefit of our investors and analysts, we will be posting financial information for each quarter 2014 in the Investor Relations section of our website shortly to reflect the financial results of the Pessac facility as discontinued operations.
Flamel reported total revenues during the fourth quarter of 2014 of $3 million, an increase of $2 million in revenues compared to the prior year period. Product sales and services revenues in the fourth quarter of 2014 were $2.9 million compared to $108,000 in the prior year quarter due to sales of Bloxiverz.
A total of $9.7 million of revenues are deferred as of December 31 and $7 million relates to Bloxiverz given the sales we modeled for revenue recognition that the company has adopted and has described in our factory. The remaining $2.7 million relates to Vazculep. We anticipate that these sales will be recognized in the first quarter of 2015.
Costs of goods and services sold for the fourth quarter of 2014 were $1.4 million compared to $50,000 in the fourth quarter of 2013. This increase is in line with the increase in product sales. Research and development costs in the fourth quarter of 2014 totaled $5.6 million, compared to $2 million in the prior year period.
This increase is attributed to the company’s continued investment in its pipeline and other proprietary products and the unusually low level of R&D costs in the fourth quarter 2013 due to the release of certain payroll accruals following changes we implemented in employee compensation moving to a plan that is performance based rather than our prior plans that were based on longevity of service.
Selling, general and administrative costs were $4.1 million in the fourth quarter of 2014 versus $5.2 million in the fourth quarter of 2013. This reduction is due to the one-off contractual severance indemnities and applicable social charges accrued in the prior year period.
We also report changes in the fair value of the acquisition liabilities, which are remeasured at each balance sheet date and are recognized in the company’s reported income. These liabilities were incurred as a part of Flamel’s acquisition of Éclat in March 2012 and are tied to commercial sales of our FDA-approved products as well as other factors.
For remeasurement of the fair value of the acquisition liabilities generated a noncash expense of $22.4 million for the fourth quarter of 2014, compared to a gain of $4.5 million in the prior period, a net increase of $26.9 million. We continue to amortize R&D assets associated with the development of Bloxiverz.
The amortization expense was $10.9 million in the fourth quarter of 2014. This is a noncash expense and we will be amortizing these R&D assets through the end of 2016. Total net interest income was $552,000 in the fourth quarter of 2014 compared to interest expense of $598,000 in the fourth quarter of 2013.
Interest expense was largely eliminated with the company’s repayment of nearly all of its debt and lines of credit with a portion of the net proceeds from its offering of 12.4 million ADS’ in March of 2014 for net proceeds of approximately $113 million.
In the fourth quarter of 2014, the company had total unrealized foreign exchange gain of $3.3 million due to the strengthening of the U.S. dollar to the euro. While our parent company in France uses the euro as its functional currency, it holds over $95 million in assets that are U.S. dollar denominated which appreciated relative to the euro.
Net loss from continuing operations for the fourth quarter of 2014 was $32 million versus net income of $2.5 million in the year ago period. Loss per share from continuing operations both basic and diluted was $0.81 in the fourth quarter of 2014 versus earnings per share of $0.10 in the fourth quarter of 2013.
In addition, we have provided certain non-GAAP data that allows investors to evaluate the company’s ongoing operations.
The adjustments exclude fair value remeasurements and amortization expense directly associated with acquisition of Eclat on an after-tax basis, asset impairments, effects of early reimbursements of certain debt instruments, and unrealized foreign exchange gains and losses, and includes earn-out and royalty payments to associated with the acquisition liabilities and royalty agreement.
Adjusted net loss for the fourth quarter of 2014 was $4.7 million versus adjusted earnings of $154,000 in the fourth quarter of 2013. Adjusted loss per share, both basic and diluted was $0.12 in the fourth quarter of 2014 versus adjusted earnings per share of $0.01 in the prior year period.
With respect to cash and marketable securities, we ended the fourth quarter 2014 with the total of $92.8 million, compared to $76.4 million as of September 30.
This cash increase of approximately $16.4 million over the quarter reflects cash use for continue investment in the company’s product pipeline, and other general and administrative costs related to the growth of the company, offset by the cash in flow resulting from the sales of our development and manufacturing facility and the investment of €10.5 million or approximately $30 million made by Recipharm in Flamel’s stock.
We anticipate Flamel to be -- will be cash flow positive in 2015. Now turning to Flamel’s full year 2014 results, Flamel reported total revenues during the 12 months ended December 31, 2014 of $14.8 million, an increase of 253%, compared to total revenues of $4.2 million in the 12 months ended December 31, 2013.
Product sales and services revenues in the full year 2014 were $11.9 million, compared to $1 million in the prior year quarter -- prior year, since no sales of Bloxiverz were recognized in 2013. Net loss from continuing operations for 2014 was $89 million versus a net loss of $46.5 for 2013.
Loss per share from continuing operations, both basic and diluted was $2.46 in 2014, compared to $1.83 in 2013. On a non-GAAP basis, adjusted net loss for 2014 was $20.3 million, compared to $15.7 million for 2013. Adjusted loss per share, basic and diluted was $0.56 in 2014 compared to $0.62 in 2013.
Before closing, I want to comment on our tax situation. In expectation of generating pre-tax income in 2015 and beyond, the company opened Irish subsidiaries in 2014 and this entity houses all intellectual property related to our proprietary technology. That being said, our near-term revenue stream will be generated essentially in U.S.
from Bloxiverz and Vazculep, while our R&D expenditure is essentially in Europe. Hence, the relative location of our income in the U.S. versus our expenses in Europe will likely increase on the income taxes. In addition, due to the potential timing of Bloxiverz revenues, we will likely use our U.S.
net operating loss carry forwards faster than originally anticipated. While these now also help to offset some taxes in 2015, we estimate that our tax rate for the full year 2015 will be somewhat higher than the U.S. corporate tax rate.
The opening of the Irish subsidiary of relocating our intangible assets to the subsidiary were initial steps in our tax planning as we transition to being a profitable company. Management is intently focused on implementing further actions to manage our global tax rate.
Although for the most part, this is limited to medium and long-term revenue streams. We will update investors as actions our planned and implemented. With that, I will now turn the call back over to Mike before taking questions.
Mike?.
Thank you, Siân. In summary, Flamel in our view has had a transformative year. We believe that Flamel is an excellent investment, based upon our accomplishments to date in our upcoming financial and clinical results. First, Bloxiverz has an exclusive position today in the marketplace at substantially higher pricing.
And we anticipate supplying the market with just one other participant through 2015 and possibly into 2016, based on information that’s available to us today. Sales of Vazculep are proceeding better than expected, and we anticipate the FDA will take action in 2015 to remove the unapproved manufacture from the market.
Second, as we look into the future, we believe that many investors do not fully appreciate the value that we anticipate for Bloxiverz and Vazculep revenues beyond 2015, both of these are sterile injectables.
Due to the difficulty and manufacturing these drugs and FDA compliant facilities, typically the sterile injectable market is characterized by having just two to four manufacturers for most products.
Accordingly, although we expect additional suppliers of neostigmine and phenylephrine, we believe that Flamel’s market share and pricing for Bloxiverz and Vazculep will generate substantial revenues and cash flows for the company for a number of years after competitors enter these markets. The value of these products tails should be significant.
Third, Flamel has an excellent pipeline of new products based on our proprietary drug delivery technologies, apply to known compounds. As I mentioned, we’ll report important clinical data throughout 2015. By the end of the second quarter, we expect data from our LiquiTime Guaifenesin and Trigger Lock opioid clinical trials.
In the second half of 2015, we’ll have data from the Medusa exenatide Phase 1 clinical trial and LiquiTime ibuprofens pivotal trial. We also anticipate initiating our Sodium Oxybate Pivotal Study by year end and we will know more after meeting with the FDA.
Finally, Flamel will be strongly cash flow positive in 2015, which will only add to the cash of over $90 million on our balance sheet at year end 2014.
Our growing cash balance will give us the flexibility to invest in our current pipeline of proprietary products, seek additional products to add to that pipeline and explore selective business development opportunities. It’s for these reasons that we believe that Flamel is an attractive investment and we will continue to be build shareholder value.
We appreciate your participation on today’s call and we look forward to providing you with updates throughout the coming year, as Flamel continues its mission of building a strong specialty pharma company with outstanding drug delivery capabilities.
Now, before we begin our Q&A, I’d also like to mention that we are going to be joined by Steve Lisi, our Senior Vice President of Business and Corporate Development to take your questions. At this point, operator, I’d like to open the line for questions..
[Operator Instructions] And we will go first to John Boris with SunTrust..
Thanks for taking the questions. The first question has to do with both, Bloxiverz, Vazculep..
Sure..
On Vazculep in particular, it would certainly appear that you are gaining share on the 1 mL, where there is some modest competition but it appears that you are going to have an exclusive position with the 5 and 10.
Can you please us understand your consideration for taking price, especially since realized price takes several months to actually be realized, but why haven’t you taken a price increase on the 5 and 10 ml in anticipation of the removal of Sandoz on the 5 and 10? And then on Bloxiverz, your current revenue assumption, obviously heavily dependent on this.
I think Teva indicated on its conference call that it doesn’t plan on being in the market in ’15. We also heard that Merck's Bridion is going to issue a complete response letter.
Any other competitors or assumptions because it would appear that you are in a pretty good position with Bloxiverz in light of those announcement, but any other pushes or pulls on that revenue assumption that we should be thinking about?.
Right. Great question, John and I’d be glad to answer. First of all, let me start in the reverse order as it relates to Bloxiverz. I think your commentary is spot on.
We understand that the Adcom meeting that I think was originally scheduled for yesterday was canceled, as the FDA wants to pursue the study of additional investigation sites with Sugammadex. And so early on, it looks like for, at least the immediate future is not something that we have to think about.
In terms of neostigmine, we’ve reiterated our guidance. Obviously, we believe that this is going to be an excellent product. We contemplate it will most likely, that for the time being be just two of us in the marketplace.
We were, I would say buoyed by the pricing that we’ve heard and it’s been reported for our competitor, which indicates that this will be, could be a very attractive market for now and the foreseeable future. So, we think we are on target for that.
We don’t have any additional intelligence, if you will to indicate that we are going to have more competition. In terms of our competitor, I think announced previously or we are told that they anticipated shipping in April. We have no update to that.
But I can tell you that as of this moment in time, we are not aware of any potential contract pricing out there. And so we will continue where we are continuing to supply the market and it’s quite clear today. We are certain we have a 100% share. So it will be, we think an excellent product and continue to be for the immediate future.
In terms of Vazculep, we want to -- we obviously and I think our history shows you that we are interested in maximizing the return on those products for our investors. As you were correct, we split the 1 mL with another party and unapproved products. The other provider of the 5 and the 10 mL is an unapproved product.
Sandoz has intermittently being in and out of inventory. We understand that they may very well for the time being, be out of that market and obviously, when we feel comfortable that we’ve satisfied the FDA about our ability to supply demand, we will make sure that our shareholders get a fair return on it. But we think we are very close to that.
And hopefully that answers your questions..
No, sure, it does. Just a quick follow-up on accounting question or a couple of accounting questions. On the NOLs that you have trapped in France, especially now since you’ve moved your intangible assets as part of your global reorganization, just any thoughts of what you have trapped in terms of NOLs in France or anywhere, and/or in the U.S.
that can be utilized to help minimize tax in U.S.
and your tax rate going forward and your ability to use that on the valuation of those assets that you move out of it?.
All right. Siân, you’d like to take that question? That’s good..
Okay. So in terms of -- yes, in terms of no NOLs we have accumulated both those pricing in France and the U.S. We expect those NOLs in France to be utilized on our 2014 income, as a result of the restructuring activity that went on at the end of 2014. To the extent, they can be utilized.
They clearly can only be utilized on any revenue generating activities at this stage in France. So turning to the U.S. situation, we are in the process of building up our annual report and we will have the detail in that.
At this stage, we expect to have full forward losses in excess of $45 million, until we see that offset any revenues generation in 2015. And we’ll keep looking at any other opportunities to use this for any remaining portfolio offices that it came from to the extent we can in light of textures, tax regulations..
Okay. Thanks for that.
One last one, since you’ve indicated that you will LiquiTime technology and you potentially targeting some potential upfront payments in structuring deals before the end of this year on the LiquiTime products, how should we be thinking about you monetizing the upfront payments, will there be monetized immediately or will there be amortized or how you are going to handle those once you ink the deals?.
Well, Steve Lisi is intimately involved in that activity and Steve, if you want to take a question, it would be great..
Sure. John, we -- obviously, we don’t have a deal done and we are not going to talk about upfronts might or might not be. But obviously as you know, anything upfront will be cash in our hands and how we account for that from an accounting perspective. I don’t know the answer to that at this point.
We certainly would have the cash to use, but we probably would do some sort of amortization of those upfront payments over some period of time. But at this point without any deal structure in place, it’s hard to give you a definitive answer. Sorry, John, I don’t know if you have any follow-up to that..
Thanks for taking the questions. Appreciate it..
Sure. Thank you..
We will go next to Jason Gerberry with Leerink Partners..
Hi, guys. This is Derek on for Jason. Thanks for taking my questions..
Sure..
First, on UMD 3, can you just give us some more color on the market conditions and what kind of dynamics are in that market? I know you guys had talked a little bit about it on the call? But just trying to get a sense the competitors that are there, are they, are some of them approved and kind of the share that distributed among those competitors? And then, second, on the Sodium Oxybate, assuming Jazz’s REMS patent actually holdup, would Flamel need to develop a non-centralized REMS program in order to get around these patents? Thanks..
Okay. So, why don’t I take the first part, and Steve, you can take the second part. As it relates to ephedrine and unapproved drug thing business, we have not said nor will we talk about what the product is or the marketplace specifically there than to identify it is being worth about the $70 million.
No drug is approved in that marketplace today otherwise it wouldn’t be an unapproved drug market. If a drug were drug approved in any unapproved market, it would be required to file an ANDA rather than an NDA. So, other than to give the approximate market size which we did, that’s about all we can say about it.
And I’ll -- Steve, if you can talk to the REMS question that would be great..
All right. Thanks, Jason. So, there is a lot to happen with respect to the REMS between now and when we are going to submit our NDA. So our ultimate path-forward and our plan have not been formulated. I think there are still some outstanding issues with the generic challenges -- challenge to Xyrem.
So we will probably just kind of wait to see how that tends out before we take a final path-forward or strategy. But, you did mentioned, could we develop or maybe develop our own system. Certainly, possible, or we can come with any system we want and I can’t give you an answer on whether it would.
There would be two systems for the same patient population eventually or there would be one, if ours would be used or rather than the Jazz one or vise versa, I don’t know the answer of that.
But there is certainly several different scenarios that could play out and I think being two years roughly away from filing an NDA, it’s difficult to give you specifics on that. So I wish we could be more specific, but there’s just a lot of things that need to play out over the next two years before we implement our strategy.
So, hopefully, as times goes on, we can give you more information..
Okay.
And just a couple follow-up, as far as, kind of the Vazculep market, I know, you kind of provide a little bit of color on Sandoz, because it looks like they are having either they are exiting the market or some supply issues? Do you know which that is, is it they are just kind of exiting ahead of getting a notice or are they just having some supply disruptions? And then, as far as, the partnerships for LiquiTime? Are you looking just for one large partner or you kind of looking at maybe potentially several partners in various different, I guess, partnership structures or licensing agreements?.
So, I will differ, once again, Steve and I will split this, let him talk to the some licensing possibilities associated with LiquiTime. In the interim, your question regarding Sandoz in the phenylephrine market. We have seen the both ways. We believe that Sandoz will imminently depart the market.
But we are not in the position to be able to talk about that further. But we think it’s more of the later than the former.
Steve, do you want to take the second question?.
Sure, Jason. Just could you just -- ask that question again about the LiquiTime licensing opportunity? What exactly do you want to know? I am sorry..
Hey, Steve. It’s Derek actually..
Derek, sorry, first, I apologies..
Yes, yes. No worries. No. Just wanted to get a sense of the partnership.
So are you looking kind of for one large partner to -- for both products, are you looking at maybe a partner for each product or just depending on kind of the geographies where you can actually sell the product at the end of the day? Are you just kind of looking for a global partner, will you be partnering these out in the various different partners through the globe?.
Well, the first part, I think, it’s -- we are looking at licensing our franchises. So, yeah, I think, one partner is probably what we are looking for not a one partner for ibuprofen and one for guaifenesin and one for others.
Especially when talking about combination, it’s kind of tough to have separate monotherapies out there with different people and then you want to put combinations together. So we are looking for one partner for the entire product line.
And from a geographical standpoint, I really, it’s difficult to answer the question, there are obviously or not a -- there is not hundreds or even dozens of companies out there who are global OTC players. So it will be nice. It’s very simple to have one partner.
But there are some areas of the world where you may want to have a local partner and we may have more than one partner. So that’s possible.
But, certainly, there would be only one partner for the whole product line and possibly, geographically, maybe there would be someone in South America or something like that or Japan or something, we have to see, but….
Okay..
… we have to see how things progress..
All right. Thanks guys..
Thank you..
And we will go next to Jim Molloy with Summer Street..
Hi, guys. Thanks for taking my questions. I had a quick question on the revenue recognition on the Bloxiverz.
But first, can you breakout with the Bloxiverz or Vazculep for fourth quarter? But then the revenue recognition method on Bloxiverz, could you walk me through that a little bit more detail and it’s a big number?.
Yeah..
I was generally think, where do you the returns are before you can contact, obviously, it has been out there for awhile, you should know by now I guess? But could you walk me through that please?.
Yeah. So, as you heard, Siân, mentioned, the carryover unrecognized revenue for Bloxiverz was $7 million, that’s a lot. Typically the rules on recognizing revenue tightened up pretty good over the last couple of years and the burden is greater than it’s been in the past.
Amongst the things you look at and the most important is the history that you have with the product. And if you look back and if you know, Jim, from our history with the product, we went for a period of time and really didn’t sell any, to speak up, waiting on the unapproved drugs to be removed from the market.
And then finally, when we sold them over the course of Q4 and early Q1 this year, we saw those products kind of dry up completely. So the couple of issues is we still don’t have in our view and a few of our auditors, enough of our solid history to be able to recognize all of those revenues for 2014.
Remember that the price increase that we employed in November for GPOs and their hospital members really didn’t take effect till like mid December. So you had sales at different levels in medical course and even now that we have competitor, we took a more prudent approach to defer those revenues.
And you’re right $7 million as compared to the aggregate is a pretty good hit. We will and do contemplate recognizing all those in Q1..
Okay. Great. Thank you. And you reiterated the size of Eclat number three around $70 million. This is back to original Bloxiverz placing and kudos to guys well on the Bloxiverz pricing change. I think it was a very smart play.
I mean, how does that -- is Eclat number three four times as big as that $70 million, should it be bigger a market there?.
Well, that’s a great question. I think actually, maybe the first time we ever mentioned, I think, it was like $25 million. And of course Bloxiverz market is larger today. I think that’s a function of what the marketplace allows you to do when you get there.
And clearly, as you can see from our approach to Bloxiverz, we believe that having gone through the time and the money and the expenditure of the resource to pursue these kinds of products, we have the right to have a return and we’ll do that.
But I think you have to measure that predicated upon each product and each point in time over the course of its lifespan. I think the takeaway for all of these kinds of products is, is that at the end, they actually go on longer people think they do.
And our ability to continue to have a viable role in both phenylephrine and Bloxiverz even after competitors come is still quite substantial. So I don’t know if I answered your question. But I think we don’t know the answer to that. So we’ll get there and see what the market looks like..
Okay. Great. Then last question and thanks for taking this. I’ll hop back in the queue..
Yeah..
The -- you guys have got a ton going on, I mean, one of the more active development companies -- of the companies that I follow. And a lot of moves going on, things going on at Ireland is, one of the challenges that often confronts smaller companies is having adequate people in place to manage all the stuff.
Could you walk a little bit through and also looking in, how can we get confidence in advance, you guys -- you got even there, you’ve got enough people to shepherd all these things across the finish line, which is fantastic pipeline?.
Yeah. Well, I think your point is very well taken and it is a challenge for the company. And we’re working to address that challenge. When you begin to -- when we moved our intellectual property at Ireland, it’s insufficient as you know, simply to do a paper transaction, you have to have a viable organization.
You have to be able to pass the red base test to indicate that you are in fact doing the things that are supposed to be done to be justified as an Irish company. And that also -- for that matter applies to our operations in France as well.
So the long and short up it is, it is one of our biggest goals and objectives over this year and over the course of this year and over an early part of the year is to get the right resources in place and to be able to make sure that we don’t lose the stab.
And we are devoting every efforts of doing that but it’s something we’re going to continue to have to follow and monitor and stay on top. Your point is well take, Jim..
Thanks for taking the question guys..
Sure..
We will take our next question from Matt Kaplan with Ladenburg Thalmann..
Hey guys..
Good morning Matt..
Good morning. Congrats on a tremendous progress during 2014. Great job. Some questions as follow-up on -- first starting on the Vazculep market dynamics now in terms of -- what are your thoughts in terms of that product now.
Are you having little bit more visibility in terms of getting the non-approved products off the market and having the one gram competitor -- 1 mL competitor, what do you -- any new guidance or estimates you can give us for that products potential?.
No. I think it’s incorporated in our overall guidance that we originally issued back, Matt, -- I remember, I guess end of the year and that we just reaffirmed today. And Vazculep is a piece of that.
I think that it’s based upon our expectation, understanding of the marketplace today and the marketplace today has at least from our modeling purposes has West-Ward in on the mL and has Sandoz in on the 5 and the 10.
If the 5 and the 10 competitor goes away and we are able to do it, then potentially the market is even larger than we had originally contemplated. One of the things that we learned from the Bloxiverz expert instances, the removal of these things is never instantaneous, right.
And so we do think that there is upside to Vazculep, but we are not ready to quantify that in anyway, shape or form, Matt..
Okay..
But I think we find ourselves here in March in a pretty reasonable position on that product..
Okay. Very good. And then in terms of your pipeline going into a little bit more of the strategy there too. You detailed your strategy in terms of moving LiquiTime slower.
But strategy for the Medusa program in terms of exenatide, is that something you partner after you develop the data later this year and then similarly for the Trigger Lock, what’s you business strategy there?.
Well, Steve, you want to answer those for Matt?.
Sure. In short, Matt, both of them are to be partnered out. We don’t have infrastructure to do something in a type 2 diabetes market with a biosimilar. So when we get sufficient clinical data, we will be looking for a partner, so that will be obviously prior to a Phase 3 pivotal study, we would seek a partner.
And with respect to the [Boston opioids] [ph], I don’t think we have the commercial infrastructure. It’s a battle in that space either. So, we will probably look to partner both of those programs at the appropriate times unless something changes with our infrastructure, that’s the plan. Yeah..
Good. And then with respect to infrastructure and it’s just a follow-up question in terms of, with all the clinical activity that you have going on this year and you touched on it little bit.
But can you talk a little bit about the infrastructure that you now have at -- I guess maybe north of it, Mike, in terms of the clinical and regulatory and a team that you have in place now to drive the pipeline forward?.
Well, without speaking specific numbers, Matt, I can tell you that we -- our clinical operations are going to be based in Ireland. We have several people that were hired and we still have some more hiring to do. We are doing that. We are utilizing outside sources.
We are doing all the things that you can do, including use of consultants to make sure that we move that forward as rapidly as we can. We’ve recognized that you can’t do what we are trying to accomplish with the same kind of cash that Flamel has had historically. It’s just -- it's a different business. We are doing different things.
Historically, the company never had clinical expertise, we never made it as you know, but we are hiring in that area. We’ve already started that process. We are very pleased with the people we have and we will continue to enhance that to make sure that we don’t miss a step.
And it’s an important part of our business and it’s an important part of the future..
Yeah. Obviously, you are in a unique situation with the cash flow, you are going to have this year and you already have that you can really guide the pipeline forward like never before..
Absolutely. It gives us flexibility we haven’t had in the past, no question about it..
And an accounting question, I guess maybe for Siân, in terms of the -- you've had things break interaction in terms of the foreign exchange, the strength of the dollar and you’ve been able to show the gains in terms of the foreign exchange but you haven’t recognized.
How do you ensure that you maintain that and is there a hedge strategy that you are putting in place to make sure -- obviously the strength of the dollar perhaps won’t last forever, but what’s your strategy there to maintain those gains that you fortunately had?.
Siân, I think that was for you..
Yeah. Hi, Matt. Obviously, the whole structure for Flamel changed over the last 12 months so that is one of the key elements that we are looking at currently. As I spoke too previously about our revenues being essentially U.S. based, we will be generating U.S. dollar cost associated in euros.
So these are things we are looking at as we plan out program out 2015 to make sure we optimize what that what we can in terms of the exchange differential in the euro-dollar fluctuation..
Okay. Great. Thanks for the added detail guys and look forward to watching your progress this year..
Thanks, Matt..
We will go next to Scott Henry with ROTH Capital..
Thank you for taking the questions and congratulations on a great year. Couple of modeling questions.
Since we are going into 2015, any thoughts on R&D spending, SG&A for the year?.
Well, as you know, Scott, typically, we don’t. The only guidance really that we’ve ever given is -- and we’ve done that just for the first time with respect to our revenue expectations. I can only point you the idea that we talked a great deal about clinical development program for the course of this year. We talked about pivotal studies.
We talked about First-in-Man studies and on and on. And I think that R&D expense and our need to continue to invest and move despite blind forward as fast as we can, particularly with exciting products like Sodium Oxybate. It’s going to be significantly higher.
But I think that we are probably not able to help with your modeling at this point to be able to give you any further detail..
Okay. Fair enough.
And then you may not -- you want to give any specific detail on this either, but perhaps you just tell me is it typical when we think about Bloxiverz, the gross to net adjustment is within reason for a typical drug or anything we should think about as an outlier there?.
No, I mean, I think it’s pretty typical, as you know, from our history. We have some obligations as a part of the gross profit that we owe, as a part of Éclat acquisition. And we also have some of the net -- small portion of the net revenue, that’s owed to people who had stepped up and provide us with some capital back in '13 and early '14.
So other than that, I think you look at Bloxiverz and Vazculep for that matter as typical specialty products with typical specialty product gross to net deductions, which includes the typical returns allocations and Medicaid and GPOs and so forth. There is nothing out of the ordinary other than those which is different..
Okay. Thank you. That’s helpful. And then in the accounting items, I do see adjustment to the fair value of acquisition liabilities. And I usually think of that as either being a good thing or bad thing, because what you bought turns out to be worth more or less than you think in essence it’s in inverse to the charge.
Could you just talk about why you change the fair value of these acquisition liabilities? And is there anything to read into that and there may not be at all?.
No, we change at every balance sheet date and it’s predicated upon the value of what the company acquired from Éclat and how that changes over a period of time and things like, when your products aren’t approved, you discount them some. And as they go through and you better understand the market, they are constantly changing.
So there is -- you are right and it’s inverse to what you would expect, I mean the more valuable the asset becomes in utilizing the parameters that you use, the bigger they hit to your P&L..
Okay. So it’s still going in the right direction..
Yes. I think so..
Okay, great. And then the final question, any thoughts on, when I think about revenues for the year and with regards to the quarterly trajectory, I mean not only had expect it to be going up, but it sounds like the deferred revenues may smoothed out in the first quarter a little bit. Any thoughts.
So I guess all the pricing gains will not take effect until 2Q or perhaps a little bit into 2Q..
No, I don’t think that’s accurate. I think that the way most everyone’s arrangements with group purchasing work and decisions work is bet. If you implement a price increase today, you required by contractually to give hospitals and GPOs a 30-day notice on that.
And so I think that means that the price increase and that’s in the middle of January takes effect in the middle of February. So I do think you see substantial changes in that credit even in the first quarter. And then we will go on and understand what happens when our competitor enters the marketplace.
The long and short is the takeaway is that the market is significantly larger today than it would have been six months ago..
Okay. Great. I appreciate that color. And thank you for taking all of the questions..
Sure. Thank you..
And at this time, there are no other questions in queue. I will turn it back to Mike Anderson for any closing remarks..
Yes. So we want to thank you once again for joining us today on the call. We look forward to continuing to update you on our progress, on our second quarter earnings call. Thank you very much. Have a fantastic day..
And that does conclude today’s conference call. We appreciate your participation..