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Flamel Technologies S.A. (NASDAQ:FLML)

Q1 2013 Earnings Call

May 7, 2013 8:30 am ET

Executives

Bob Yedid – Investor Relations

Michael S. Anderson – Chief Executive Officer

Sian Crouzet – Principal Financial Officer

Analysts

Matthew Kaplan – Ladenburg Thalmann

Russell Cleveland – RENN Capital

Les Schultz – Schultz Capital Management

Operator

Good morning, ladies and gentlemen, and welcome to the Flamel Technologies Announces First Quarter 2013 Results Conference Call. Please note that this call is being recorded. (Operator Instructions)

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

Bob Yedid

Good morning, and welcome to Flamel Technologies’ first quarter 2013 conference call. This is Bob Yedid of ICR, Investor Relations. Before we begin, I’d like start with some cautionary statements. The following presentation regarding Flamel Technologies S.A. includes a number of matters, particularly as related to the status of various research projects and technology platforms that constitutes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

The presentation reflects the current views of Flamel’s management with respect to future events and is subject to risks and uncertainties that could cause actual results to differ materially from those contemplated in such forward-looking statements. These risks include risks that product and development stage may not achieve scientific objectives or milestones or meet stringent regulatory requirements, uncertainties regarding market acceptance of products and development, the impact of competitive product and pricing, and the risk associated with Flamel’s reliance on outside parties and key strategic alliances. These and other risks are described more fully on Flamel’s public filings.

Except as required by law, Flamel do not intend and disclaims any duty or obligation to update or revise any forward-looking statements contained in this presentation to reflect new information, future events or otherwise. After prepared remarks, we’ll be opening the call to a question-and-answer period.

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

Michael S. Anderson

Good morning, ladies and gentlemen. Thank you all for joining us today. I’m pleased to report that Flamel continues to make great progress in our transformation from being a standalone drug delivery company to a specialty pharma company with outstanding drug delivery capabilities. As noted before, we believe this is an important distinction. We’re pleased to see advancement on a number of fronts.

We are focused on the development of our own proprietary drugs to drive sustainable revenue and earnings growth for Flamel. In parallel, we continued the drug development side of our business with several partners and that has not slowed down. We believe that we have excellent technology, and we intend to broaden its use. Moreover, we continue to make solid progress on the business development front, and we will share more details on new deals in the coming quarters.

First, as we mentioned on prior calls, our first NDA submission for a new hospital based product is at the FDA, and we continue to feel that we have brought our best resources in clinical and regulatory affairs to bear in the preparation of the submission. The FDA’s PDUFA target action date for our NDA is May 31, 2013.

We’re actively preparing for product launch, while we await the FDA’s action. We expect to have the product available to providers and patients as quickly as possible after an approval. If the product is approved on time, we expect the product to generate meaningful sales in 2013, and to have a positive impact on our financial results by the end of the year. The product is targeted for the hospital setting, and it could contribute from $25 million to $35 million in peak annual revenues for Flamel.

Moreover, we anticipate the drug will generate gross margins on par with other specialty pharmaceuticals in the hospital market. As we have mentioned previously, in order to maximize the value of this product and its potential launch, for competitive reasons, we are not disclosing the molecule or the indication. However, we will be updating investors at the appropriate time with substantial information about our products.

We filed our second NDA in the first quarter. As noted in our press release and earlier this morning, we have received a ‘refusal to file’ letter from FDA on the filing citing our need to reformat parts of certain databases within the application. The letter does not comment on the approvability of our product and we are working closely with the Agency to provide in the requested format the information requested for resubmission of this application as quickly as possible.

We’re hopeful that this will cause a minimal delay. While this is somewhat disappointing, we believe that FDA’s request to be very modest, and we are confident that we will be able to resubmit shortly. The product and question is derived from the pipeline of Éclat projects, which we acquired in March of 2012. I’ll be discussing our pipeline at greater length after Sian’s financial remarks.

Thirdly, we ended the quarter with $15.4 million in cash, in part due to the debt financing with Deerfield Management, one of our largest shareholders, which raised $14.5 million in net proceeds in February of 2013. We estimate that the current cash balance provides us with the means to advance our extensive R&D portfolio, to adequately prepare for our near-term product launch and to pursue business development opportunities on a selective basis.

At this point, I’d like to turn the call over to Sian Crouzet, Flamel’s Principal Financial Officer to discuss the financial results from the first quarter. Sian?

Sian Crouzet

Thank you, Mike and good morning. Total revenue for the first quarter of 2013 was $5.1 million compared to $7.4 million in the first quarter of 2012. The decrease was primarily driven by lower product sales and services, and lower license and research revenue.

Product sales declined by $1.3 million versus the prior year period due to the timing of GlaxoSmithKline’s orders of Coreg CR and the recognition of $0.9 million of payments in the first quarter of 2012 related to the new supply agreement.

License and other revenues were lower by $0.8 million year-over-year. While we continue to seek meaningful partnership opportunities, we are equally pursuing and increasing our focus on our internal platform products as Mike explained and revenues from contracts with other drug companies have declined.

Total costs and expenses during the first quarter 2013 increased from $7.4 million in the first quarter of 2012 to $15 million in the first quarter of 2013. As explained in our press release this morning, there was a large non-cash accounting entry from the fair value measurement of the liabilities outstanding for the acquisition of Éclat. This adjustment went from a favorable adjustment of $5.1 million in the first quarter of 2012 to an unfavorable adjustment of $3 million in the first quarter 2013, a swing of $8 million.

As a reminder, the configuration for the acquisition of Éclat included the issuance of a $12 million note whose repayment is tied to the approval and net sales of certain Éclat products, 3.3 million common stock warrants and earn out payments based on the gross profit achieved on the Éclat product.

These commitments with earlier this acquisition was over $50 million and then are valued at just under $35 million. These valuations are based on current information and data including financial projections related to the potential of the Éclat products as well as Flamel’s share price, and so far as it influences the value of the warrants.

Excluding these adjustments, first quarter 2013 operating expenses are modestly lower this year. On an adjusted basis, cost and expenses declined to $12 million in the third quarter of 2013 compared to $12.5 million in the prior period.

Research and development costs in the first quarter of 2013 totaled $8.5 million versus $6.0 million in the year ago period as we spend in support of our Éclat pipeline and other products including paying a $2 million filing fee for our second NDA.

SG&A expenses was substantially lower this quarter at $2.5 million in the first quarter of 2013 compared to $5.2 million in the prior year quarter. This is principally due to expenses incurred in the first quarter of 2012 upon the departure of the Company’s previous Chief Executive Officer and legal costs associated with the acquisition of Éclat.

Also you should be aware that year-over-year expense patterns were affected the company incurred Éclat expenses for the full first quarter 2013 compared to only two to three weeks in March 2012, resulting in an increase of $1.4 million expenses included in both R&D and SG&A expenses.

Total interest expense for the first quarter of 2012 was $0.4 million, compared to interest income of $0.2 million in the prior year period, principally due to the interest incurred on a $15 million debt financing compared to – held over the quarter.

Net loss for the first quarter of 2013 was $8.8 million versus a very modest profit in the first quarter of 2012. Net loss per share was $0.35, compared to a net income per share of $0.0 in the first quarter 2012.

Excluding the impact of the re-measurement in fair value of acquisition liabilities, net loss or loss per share for the first quarter of 2013 was $5.9 million and $0.23, respectively compared to $5.1 million and $0.20 in 2012. With respect to cash and marketable securities, we ended the first quarter with $15.4 million compared to $9.2 million at the end of 2012.

As Mike mentioned, we closed the debt financing in February 2013 for net proceeds of $14.5 million. The financing is advantageous as it allows the company to invest in products that we anticipate will come to the market in the near-term as well as products in our R&D pipeline, while avoiding dilution to the current equity holders.

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

Michael S. Anderson

Thank you, Sian. At this point, I’d like to take an opportunity to provide a broader discussion of Flamel’s operational progress and our corporate strategy, so that our current and our prospective shareholders understand the Company’s direction.

As we mentioned on the fourth quarter call, our new strategy has broadened Flamel’s revenue base from a drug deliver company with just one source of revenue a year ago to a specialty pharmaceutical company that now has three distinctive sources of revenue covering the short-term, the mid-term, and the long-term.

First, in the near term, we’re focused on the Éclat pipeline that was acquired in March of 2012. Through resources we have committed to-date; we have one NDA on file with the FDA with the PDUFA date at the end of this month. For our second Éclat project, we anticipate refilling our NDA shortly after reformatting some of the databases. Moreover, we anticipate the potential filing of additional NDAs from the Éclat pipeline in 2013 or very early 2014.

With regards to our specific market strategy and therapeutic focus of these products, we will not discuss specifics at this point for the previously mentioned competitive reasons. However, as we received product approvals or product acceptances from the FDA, we’ll communicate more specifics proactively with investors.

For now, I am comfortable telling you that we have more than a dozen molecules on our near-term and mid-term pipelines in various stages of R&D completion and development, including several approaching the clinic. Those products cover a gamut of therapeutic categories, including CNS, Hepatitis C, heart disease, pain management and others.

Second in the mid-term, Flamel has a series of four internal proprietary products in our pipeline, some of which are getting close to human clinical trials and other products that are in preclinical testing. In each case, these products utilize one of Flamel’s proprietary drug delivery technologies that will either increase the efficacy of the drug, reduce cost versus alternative therapies and/or reduce patient side-effects and thereby improve patient compliance, which ultimately reduces health care costs in the long run.

We are self funding each of the mid-term products and we have made product selections based upon a combination of potential commercial value, technical difficulty in moving the project to approval and the cost associated with the product development. From a regulatory perspective, some of these pipeline products will use the 505(b) (2) pathway.

We believe as a general rule, they will be faster and less expensive development projects and ultimately less risky, although technical hurdles are always possible when you add drug delivery to molecules. If we are correct, then our shareholders should see these programs advance much faster than as been the case in the past.

At the logical stage of the development process, management will evaluate whether we can effectively commercialize them ourselves or whether our shareholders would be better served by our funding commercial partners who can more effectively create value in the marketplace. We view these pipeline products as midterm revenue opportunities from Flamel and we believe that Several could have very high commercial value.

Finally, we continue to leverage our world-class drug delivery platforms to aggressively pursue product partnerships with large and small pharma partners where they pay for the development costs. Some of those projects are moving forward at a reasonable pace and are funded by our pharma partners. We have a number of programs in process in both clinical and pre-clinical stages. Please recognize that most of these projects are dependent on our pharmaceutical partners’ actions and are in some cases out of our direct control.

Generally, this area of our business continues to progress well, however. This three-pronged strategy focusing on generating revenues for the short, mid and long-term is built upon a very contemporary and state-of-the-art portfolio of drug delivery technologies.

We intent to use it to differentiate and to protect our products. For example, Trigger Lock, our proprietary technology that makes significantly more difficult to abuse narcotics may very well be one of the few technologies capable of meeting the FDA’s new draft guidance on abused resistant requirements.

As many of you are aware, within the past month, the FDA has articulated its interest in no longer approving long-acting opioids that do not contain abuse resistant technology. Through the approval of Coreg CR, a beta blocker from our partner GSK, Micropump is a proven and an approved technology for small molecule drugs. In short, our portfolio of technologies including Trigger Lock, Micropump, Medusa, LiquiTime and others are broad, novel and effective.

Ultimately the senior management of Flamel believes that execution of this strategy will build value for shareholders in both the near and the long-term. We are committed to increasing the visibility to our shareholders into our pipeline as our programs advance and we look forward to sharing meaningful updates from our pipeline as they become available.

We are also seeking to increase investor knowledge of Flamel and will appear at selected Healthcare Investment Conferences throughout the year. Just last week we presented at Needham’s Healthcare Conference in New York City, while we have spent much of the past year improving our execution, we now feel comfortable being able to better articulate it to Wall Street. In sum, I’m excited about Flamel’s prospects. There is a lot to accomplish yet in 2013, 2014 and management is aggressively focused on the important activities to move Flamel forward.

Our objective here is to create real shareholder value, the way we will do that is by moving our technologies to approvals by regulatory bodies no matter where they may be. We’re not here simply to build a break-even arrangement. Our objective is to build the company with substantial revenue and profit and we believe, we’re well on our way.

We appreciate your participation on today’s call and at this point, operator, I’d like to open the call for questions.

Question-and-Answer Session

Operator

(Operator Instructions) We’ll hear first from Matt Kaplan with Ladenburg Thalmann.

Matthew Kaplan – Ladenburg Thalmann

Hi good morning guys, can you hear me?

Michael Shannon Anderson

Yes good morning, Matt.

Matthew Kaplan – Ladenburg Thalmann

Great, great. Well thanks for taking my questions. First one has to do with your ‘refusal to file’. Can you give us a little bit color in terms of what the deficiency is and how this will impact, I guess the timing of that NDA, what’s your visibility for that now?

Michael Shannon Anderson

Right. Well, Matt, as we mentioned on the call, we’re really unprepared to talk in much more depth about the issue. In essence, the application had a couple of databases that were formatted and installed that the FDA want it changed and we’re in the process of doing that. We are fairly comfortable that, that is the only issue and we’re in the process of doing that as we speak and would expect to re-file it as quickly as we possibly can. We have been in contact with FDA and we continue to have discussions with them, and we’re very hopeful that the delay that this causes would be minimal. Other than that, I can’t – frankly can’t put anything much more concrete to it than that for you.

Matthew Kaplan – Ladenburg Thalmann

Okay. And just a quick follow-up on that, in terms of the timing of the filing and its acceptance, how does that impact the PDUFA date, for example, I guess you filed sometime in the second quarter, will the filing now be sometime, you know, let’s call it in the third quarter or perhaps even earlier this quarter, such that, that is the new filing date and then it pushes, that’s when the clock starts or how does it work?

Michael Shannon Anderson

Well, I think each case is subject to something a little bit different. We certainly don’t anticipate that we go to the third quarter, if we can possibly get it filed very quickly. We’ll do that, we expect to be able to do that and then we’ll have to discuss with FDA what the ramification of the PDUFA date is, I think that we should probably expect some small delay, but I don’t think – we hope that it is not going to be meaningful.

Matthew Kaplan – Ladenburg Thalmann

Okay. I guess my second – thanks for that color.

Michael Shannon Anderson

Sure.

Matthew Kaplan – Ladenburg Thalmann

My second question has to do with your pipeline. You mentioned more than six molecules in various indications and for internal products. Can you give us some more detail in terms of, perhaps some upcoming milestones for those four internal programs?

Michael Shannon Anderson

Yes. As we mentioned, we do have four projects of our own. With others in the queue, if you will, that we will begin working on as soon as we’re in a position to be able to do that, not only from a financial resource perspective, but also from a human resource perspective. We don’t have infinite capacity to do as many projects as quite frankly we’d like to do, particularly when you consider it that we have projects that are sponsored by some of our partners ongoing and we have to be mindful of those as well.

But the four projects that we have as we’ve already alluded to internally over a – going internally that we’ve alluded to in the past, include the examples of Trigger Lock, Medusa, Micropump and LiquiTime; they are represented by each of the technology platforms that we have.

We’ve selected products match that we believe are commercially interesting and viable and then a couple of cases could conceivably be quite large. But also we utilized our understanding of the regulatory pathway and the cost associated with doing these. What we are is a company who would like very much to give its technologies approved, so that we can site those and validate those technologies with the benefit of other partners down the road.

We chose these products believing that if we move them forward, we could get products into the marketplace and be able to point to these various projects as being examples of our technology that have been approved by FDA. It’s in my view, a really solid strategy and of course like any good solid strategy depends 100% on our ability to execute it. And we have done as you may recall from previous conference calls and previous discussions and press releases, we have done an awful lot of changing here over the last year.

We have reevaluated and redeployed our entire R&D organization. We have changed the structure to create a group who is responsible solely for the completion of projects. Their job and they will be measured buyback will be to get projects done within the right cost frame, on time and with the very highest quality. We’ve separated another group into an organization that looks at improving upon our existing technologies and as the case maybe looking at new technologies that may come our way to be analyzed and examined. So, we restructured our entire focus of our R&D.

We’ve also in the past year gone through our pipeline. We instituted these four projects, and we’ve also taken out of the pipeline projects that we believe will not be as commercially viable projects that we don’t think would have had the same opportunity for success. And so what we’ve tried to do is focus our entire corporate and company effort of building products with technology that can be approved and done so with reasonable expediency.

In terms of the milestones, which was your ultimately question is, is that we have several of those that we’ve moved down the preclinical pathway with, we will begin most likely in human studies on at least one, if not two of them this year. But again, we’re making sure that we can balance the internal needs with the projects that we’ve previously committed to from our partners. And so far we believe that’s working quite well.

Matthew Kaplan – Ladenburg Thalmann

Great. Thanks a lot for the details Mike.

Michael Shannon Anderson

Sure.

Operator

And we’ll take our next question from Russell Cleveland with RENN Capital.

Russell Cleveland – RENN Capital

Hello Mike, thank you for the call this morning. It was very good to get the articulation of where we’re going; I really appreciate that and got a much clear understanding of Flamel and what you’re doing. The only area that still seems to be confusing to the marketplace here is, are those financially, I mean, are we talking about a $50 million, $100 million, $200 million. Can you give us a little bit more on where we would like to be not a forecast, but a goal in two or three years?

Michael S. Anderson

Right. I think that’s a great question Russell, we appreciate it. As you know when you have a portion of your business dependant upon partnerships, its sometimes difficult to be able to assess that given the changing demands and needs and strategies or partners, and that’s one of the reasons frankly that we began with this notion of becoming a specialty pharma company and we began developing our own products.

I can tell you today that the products that we have in development, the four products that we’ve talked about, if you wanted to look at market sizes as an example those four products have an aggregate value of probably some more just under $2 billion anonymously too, I don’t think that we’re going to be a $2 billion company in five years at least not that quick.

But what I am trying to describe to you is that the products opportunities are out there depending upon whether we end up marketing them ourselves and some we will, some were quite capable of doing that with limited infrastructure, while there is even in those four projects which will grow as we move forward will be able to be sold by us directly, and others will have to depend on partners who have an expertise in a certain therapeutic category. We get – go out and build 50 or 100 person sales force and we would never probably have the expertise or scope that we need to most effectively monetize it. So the long and short of your answer is, is that we’re talking about product opportunities that are quite large here.

Our objective is not to become a $50 million company. Our objective is to do that in short order and then well beyond that. And frankly I think we’re well on the way. The best way we can do that is to control our own destiny and again to execute. So I don’t know if I answered your question as…

Russell Cleveland – RENN Capital

Well, that’s good. I appreciate that and…

Michael S. Anderson

As you might have liked, but big opportunities if we do…

Russell Cleveland – RENN Capital

Yeah, absolutely. I appreciate it and I’ll get back in line. Thanks so much.

Michael S. Anderson

Thank you.

Operator

(Operator Instructions) We’ll hear next from Les Schultz with Schultz Capital Management.

Les Schultz – Schultz Capital Management

Yeah, Mike. I’d like to thank you for once again having your conference call that starts at 5:30 on the West Coast in the morning. I have two questions.

Michael S. Anderson

Thank you. Yeah…

Les Schultz – Schultz Capital Management

One is that, it sends you, took over the markets down – your stocks down 40% while the markets at all time highs. Do you attribute that to what you’re doing or a net ability to articulate it to the street what you are doing?

Michael S. Anderson

That’s a great question, Les. I don’t think that the value of the marketplace or the value of the stock is reflection of what we’re doing. I think if I had to choose one of your two answers, I would say that many investors don’t understand how our new model works. And we’re doing everything we can to articulate that to people. This reflects an entire different in strategy.

As you may have heard in the past, the standalone drug delivery model that existed 10 to 12 years ago, doesn’t exist today. In those models you measured companies by their biggest partners’ molecule and if you go back and you look and you look at things like Alpha and Elan and you look at things like Procardia XL, Adalat, and so forth. People measured and valued Alpha and Elan and other companies based on those molecules.

There were many other drug delivery standalone companies I happened to work for one, that didn’t join anywhere near that success. So what we’re doing is changing on the fly here. We’ve been changing for 12 months straight, and changing your entire strategy in the direction and communicating that not only to your employee, but your investor base as well is – it takes a little doing.

And I think that as our product gets accrued assuming that it does here at the end of the month, we’ll be generating revenue on the sustained basis like it hasn’t been done in Flamel for sometime. So, I don’t, other than to tell you that I don’t think people totally understand where we’re going with this, I can think of no other reason why it stand. We all have seen warm up a little bit lightly, that’s the best answer I can give you.

Les Schultz – Schultz Capital Management

Okay. My second question is Siân talked about a $2 million finder fee. Who received that and has it been previously disclosed that there would be a $2 million finder fee?

Michael S. Anderson

Finder. There is no, I think what you’re talking about is a filing fee. Until October of last year 2012, if you filed an NDA with the FDA, no matter what your NDA was, it didn’t matter whether you are Pfizer or Flamel, the cost of filing an NDA for a product that didn’t require clinical work would have been $750,000. And October of 2012 the FDA raised the filing fees for all people to $2 million, and if you’re doing extensive clinical work the filing fee becomes $2.5 million, so to put that into perspective for you Les every NDA that’s filed by anybody going forward will be $2 million to $2.5 million and that’s the price we’re paying, where in an industry it’s paying for its own regulation. That answer your question?

Les Schultz – Schultz Capital Management

Yes.

Operator

(Operator Instructions) We will move on to Matt Kaplan with Ladenburg Thalmann.

Matthew Kaplan – Ladenburg Thalmann

Hi guys, I guess I get two more now. Thank you for taking some more questions. First, can you give us some more detail and some updates on your partnered products? What – where are they in development and what – I guess what more importantly what milestone to expect from the remainder of the year from the partnered products?

Michael S. Anderson

Yeah, I’m going to say something Matt, if there were anything I could do to be able to share the intimate details of each and every one of those partnerships with you, I would be glad to do that. We do as you, but as you also know, we’re somewhat handicapped by our inability to discuss some of the progress of those, because partners don’t always want their, don’t want their details publicized as you know.

We have a number of partnerships going, because some of them are moving faster than others. We still have partnerships with people like Eagle and Tigecycline and we have a couple of others that are ongoing that you don’t know about. And the best thing I can tell you honestly is they’re moving forward in various phases, we have a couple that are moving quite well. One even recently has picked up some steam and doing quite well. We have others that are not going as fast as we would like.

And that’s in part the reason, one of the reasons that we adapted this new philosophy of trying to control our own destiny. And frankly, Matt you’ve seen this people have done this successfully time and again. So, best I can tell you is the once that we had going or as moving forward at various phases we’ve had some that have dropped out.

Matthew Kaplan – Ladenburg Thalmann

Can you quantify them for us in terms of the number of your products at this point or you have something that you can’t there?

Michael S. Anderson

I really can’t do that at this point. First of all not prepared to do it, number 2, I’d have to think about that, that’s not something we’ve done it. I am a little resistant to do that, because frankly they – things do change. Today you have six partnerships, tomorrow you have 12 partnerships, and day after tomorrow you have back down to five partnerships that sort of the nature of the business.

When you are in the business after doing partnerships with people as you know from history depending upon on the partner and the molecule and the project itself, you can often betrayed simply to do feasibility studies. One of the problems was standalone drug delivery is you do just feasibility studies, you are probably not the only one doing them, they may have engaged several people to do them. So there are just different issues that make it little difficult if not impossible to quantify that, I hope you understand.

Matthew Kaplan – Ladenburg Thalmann

No, no. Fair enough. And then next question, in terms of, you ended the quarter with about $50 million cash and maybe, can you give us a sense in terms of where that brings you and kind of what your visibility last year, current for the remainder of the year. I know there is a lot of moving parts here including the NDA, the PDUFA date at the end of the month and how that’s going to impact your potential need for additional cash but what’s your sense right now?

Michael S. Anderson

Well, our sense is that we’re going to be, first of all, to look at one quarter is tempting and there is people like to do and I do too. And our business is a little difficult to do, we have impacts from the French government that realized in different quarters and their different impacts to what our spend looks like. But to sum up rise to your question and my answer I would suggest you that if you’re assuming we get our improved volume it works out like before. We expected to will be in great shape and it will no concern whatsoever.

We do have plans that as part of our forecast going forward that if something doesn’t materialize that we expect, we can make appropriate adjustments in the way we spend money and the projects we have going forward. One of the reasons that we ended up at the end of Q4 going and talking to Deerfield about additional funding was the fact that we wanted to be able to continue this year on the same pace that we were doing our R&D in the past.

And we could have always changed that, we could have always slow it down, but at the end of the day, one of our best opportunity is to get ourselves on healthy financial footing again is our ability to continue to develop our products and the pipeline those that we have control over and that’s what we’re doing. We haven’t accelerated them, but we don’t want to sell them down either. So I think it would be fine for cash assuming we get our product approved, and as we sit here today, well we don’t control the FDA, we feel like we’re on track to do that.

Operator

And that is all the time we have for questions today, I would like to turn the call back over to Mr. Anderson for closing remarks.

Michael S. Anderson

Yes, thank you operator. And thank you each and all of you for joining us on the call today. We appreciate your time and interest and we look forward to updating you on our business in the coming months ahead. Thank you very much and have a great day. Thank you.

Operator

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

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