Decoy Therapeutics Inc. (DCOY) Q1 2016 Earnings Report, Transcript and Summary

Good day, ladies and gentlemen, and welcome to the First Quarter 2016 Flex Pharma Incorporated Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will be given at that time. [Operator Instructions]. As a reminder, this conference is being recorded. I'd now like to introduce your host for today's conference, Ms. Elizabeth Woo, SVP, Investor Relations and Corporate Communications. Ms. Woo, you may begin.

Thank you, Andrea. Good morning. Thank you for joining us to discuss Flex Pharma's first quarter 2016 financial results as well as our recent progress and outlook. Earlier today, we issued a press release announcing recent business highlights and detailing our first quarter 2016 results. You can find these documents on our website at flex-pharma.com. Today, we will be making certain forward-looking statements about future expectations, plans, events, and circumstances, including statements about our strategy, future operations, and the development of our consumer and drug product candidates, plans for future potential product candidates and studies and our expectations regarding our capital allocation and cash resources. These statements are based on our current expectations, and you should not place undue reliance on these statements. Actual results may differ materially due to our risks and uncertainties, including those detailed in the Risk Factor section of our 10-K filed with the SEC and other filings we make with the SEC from time to time. Flex Pharma disclaims any obligation to update information contained in these forward-looking statements, whether as a result of new information, future events or otherwise. We'll provide a brief overview then open it up for Q&A. And joining us on the call today is Dr. Christoph Westphal, Chairman and CEO of Flex Pharma; Dr. Tom Wessel, Chief Medical Officer; Marina Hahn, President of Consumer; Kathie Lindemann, Chief Operating Officer. And I’ll now pass the call to Flex Pharma CEO, Christoph Westphal.

Thanks, Elizabeth. Thank you for joining us today. Flex has made significant progress in recent months. Several lines of research supports the role of Chemical Neuro Stimulation, the process by which a small molecule chemical signal acting topically is translated into an electrical signal in the nervous system for the benefit of healthy athletes and patients alike. This novel and important discovery by Nobel Laureate Dr. Rod MacKinnon and Dr. Bruce Bean appears to be generally applicable method to treating disorders of cramping and spasms stemming from alpha motor neuron hyper-excitability. With this platform, we are developing solutions for both patients and consumers from the healthiest of humans, the endurance athlete to the millions who suffer regularly from nocturnal leg cramps to patients affected by severe neuromuscular conditions such as multiple sclerosis, motor neuron diseases such as amyotrophic lateral sclerosis and several other serious diseases. Our efforts in the clinical and consumer arms of the business continue to advance. Clinical results in nocturnal leg cramps. In February, we reported statistically significant positive human efficacy in our randomized control blinded clinical study of NLC with our proprietary extract formulation. The results from our NLC study were selected for presentation at April 2016 American Academy of Neurology Annual Meeting as one of only 14 abstract for the late breaking emerging science presentations. Tom Wessel, our Chief Medical Officer, presented these data and will provide further detail in his comments. The positive effects were seen across a broad range of enrolled subjects; in addition, a subset of patients showed pronounced benefit. We believe these statistically significant human efficacy data generated in this study are clinically meaningful and support using specific transient receptor potential, or TRP, ion channel activation to reduce nocturnal leg cramps. This approach may provide a promising new treatment in the future for the four million Americans over age 65 that we estimate suffer from this condition nightly and who currently have no safe and effective therapeutic options. The magnitude of efficacy in this study on reduction in muscle cramps appears similar to published Class 1 level Quinine efficacy studies. However, Quinine, the only therapeutic intervention for leg cramps with randomized controlled blinded study support for efficacy is also associated with serious adverse events and is banned for the treatment of leg cramps by the U.S. Food and Drug Administration over 20 years ago. The lack of any approved therapeutics for nocturnal leg cramps in the United States represents a significant unmet medical need. Development of lead clinic product, given the positive clinical results in NLC, we are poised to initiative three human efficacy studies in NLC, MS, and ALS this year with our single agent selective and specific transient receptor potential ion channel agonist. Recall that we nominated single agent FLX-787 which is a chemically certified TRP ion channel activator both TRPA1 and TRPV1 that is demonstrated statistically significant efficacy in humans with a stronger effect in our electrically induced cramp model as compared to the extract formulation. Consumer, Marina Hahn, and her team of brand builders have created a truly unique consumer product and brand based upon this breakthrough scientific insight. Marina will provide an update on the launch plans. Our sports beverage has been designed to stimulate sensory fibers and consequently reduce hyper-excitability in motor neurons in spinal cord leading to a rapid reflex like suppression or muscle cramping. We believe it is the only consumer product that is demonstrated statistically significant efficacy in mitigating muscle cramps in a rigorous double-blinded scientific study. The beverage is low calorie, certified USDA organic, and has been certified for sport by NSF which tests more than 230 prohibited and banned substances and allows professional athletes to take the product. Our sampling program with endurance athletes, Olympians, and professional teams starting to provide momentum for the official launch of our consumer products. Our sampling program includes pro-teams from NFL, NHL, MLB, and NBA. Olympic marathon contender Shalane Flanagan, came to our office just before the Boston Marathon and spoke about the benefits she feels when she takes the product even though she does not cramp. We expect to begin selling our sports beverage on our branded website and in specialty retailers in Boston, Boulder, and LA, in the next few weeks. We’ve been successful attracting top talents from both the biotech and consumer industries. Our consumer team brings a wealth of experience building global brands. As we move into launch mode, Kathie Lindemann, our Chief Operating Officer, with her extensive consumer beverage background at DAVIDs TEA and nearly 20 years at Starbucks will provide an overview on the business operations. With over $84 million in cash and investments at quarter end, Flex is well funded through the middle of 2018 to execute on our value creating objectives. I will now hand the call to Dr. Tom Wessel, who will update you on our clinical progress.

Thanks, Christoph. 2016 is a year of significant clinical activity for the Flex R&D team since we achieved our key goals in 2015. We have demonstrated statistically significant efficacy results in individuals with nocturnal leg cramps which exceeded our own internal expectations and we have identified our lead drug candidate, a single molecule chemically synthesized potent TRPA1, V1 ion channel activator. These achievements have positioned us to initiate three human efficacy studies in NLC, MS, and ALS this year with single agent molecules. In early February we announced that our prototype extract formulation beverage demonstrated statistically significant efficacy results across multiple endpoints in treating subjects with nocturnal leg cramps that we believe are clinically meaningful and compare well to the efficacy of Quinine. These results were presented at a late breaking abstract at the recent American Academy of Neurology Meeting as one of only 14 selected abstracts in a data bliss presentation. As a young company we are thrilled to have been chosen for two consecutive years now for podium presentations at this most important neurology conference. My presentation of these NLC results at AAN two weeks ago was met with much interest among practicing neurologists. Neurologists recognized the lack of therapeutic options for cramps to spasms and spasticity associated with many neurological diseases. The choices available to treat these common symptoms are imperfect. Anticonvulsant medications and other drugs have significant side effects and here in the United States Quinine is no longer available. In our randomized control blinded crossover study, we included healthy subject, 50 to 77 years of age who experienced nocturnal leg cramps at least four nights I believe, 50 subjects completed this study and we observed statistically significant effect on several important endpoints, cramp frequency, cramp-free days, physician-rated global the compression of change, CGI of change, difficulty in staying asleep is a sub question on the insomnia severity index and a VAS pain intensity over the last three days of each treatment period. The end results exceeded our expectations. Additionally, the formulation appear to be safe and well tolerated and no serious adverse events were reported. The positive effects were seen across a broad range of enrolled subjects. In addition, as commonly seen in CNS drugs, the subset of patients showed pronounced responses, 12% of patients had a 75% or greater reduction in cramp frequency done in the placebo group. And physicians accessed 40% of patients to be much or very much approved on active compared to 24% on placebo. These are just some of the ways of looking at clinical responses in this observation. We believe the benefits to subjects were clinically meaningful. The magnitude of effect in this study on reduction muscle cramps is similar to published Class 1 level Quinine efficacy study. As you know, Quinine was removed from the U.S. market more than 20 years ago. However it is still widely used in Europe and elsewhere. In the UK where Quinine is still prescribed, 4.5 million prescriptions were written in 2013, the population is fifth of the size of the United States. No other treatment besides Quinine has been shown to be effective for nocturnal leg cramp in randomized blinded control clinical studies and to our knowledge there are no other pharmaceutical agents in clinical development for nocturnal leg cramps. We estimate that nocturnal leg cramp effect four million Americans over the age of 65 and they suffer nightly. There is no FDA approved therapy in the United States to treat this condition. The lack of any approved medication for NLC in the United States represents a significant unmet medical need. Before going into the upcoming studies, I would like to remind you that after conducting a decomposition analysis of the extract formulation for the most potent TRPA1 and V1 agonists, we utilized our electrically-induced cramp model in normal, healthy volunteers to study various chemically synthesized TRPA1 and V1 agonists. We discovered that two separate synthesized single agents demonstrated enhanced efficacy by significantly reducing cramp intensity. These two individual TRP channel activators were superior not only compared to vehicle but also statistically significantly more effective than our original proprietary extract formulation. On this basis, we selected single agent FLX-787 to take forward as our lead drug candidate for our IND and to start clinical development outside of the United States. FLX-788 is another viable drug candidate. Now with positive results in nocturnal leg cramps we are able to accelerate product development of the single agent to treat NLC. As we previously announced, we expect to initiate another NLC study with our lead TRP activator later this year, with results expected in the first half of next year. Our current plan for the study is as a randomized control blinded crossover design and slightly larger than the NLC study concluded earlier this year which had 50 evaluable subjects. Since we have made substantial progress in our formulation work, the study article in this study will likely be formulated as an orally disintegrating tablet or ODT anticipating the eventual commercial formulation. As part of our NLC development program, we are also concurrently conducting smaller studies exploring alternative study designs, delivery mechanisms, dosage amounts, and/or product formulation. We believe these studies will help inform the planned clinical studies conducted under IND in the future, as we expect to start early next year in the United States. The study design of the MS and ALS studies outside the United States utilizing 787 will be similar to the recent NLC study design, randomized controlled blinded crossover studies. These studies are expected to initiate in the coming weeks and months. Thus, we will have several data readouts over the next year fall. In addition to our nocturnal leg cramp results, independent researchers at Penn State University recently presented results in athletes adding to the body of evidence that Chemical Neuro Stimulation via A1 and V1 TRP ion channels effectively decreases neuronal hyper-excitability, thereby preventing cramping. At the Experimental Biology Conference in April, Dr. Larry Kenney, a renowned researcher in the field of Exercise Physiology at PSU presented data from the own model of volitional muscle cramping in athletes. This is a positional non-electrical cramp paradigm closer to what athletes would experience in the real world. These experiments nicely complement our induced results and demonstrated a specifically significant benefit for our proprietary consumer formulation in reducing muscle cramps in athletes as compared to vehicle control. This effect was measured by surface EMG and showed a reduction in the intensity duration profile of the induced muscle cramp. Additionally subject ratings of muscle soreness resulting from cramps were also statistically significantly lower compared to vehicle control. As Dr. Kenney noted, these results are unique and that we have the only consumer product that has demonstrated efficacy in mitigating muscle cramp in a rigorous double-blinded scientific study. In summary, Flex is expeditiously advancing the clinical development in nocturnal leg cramps and the statistically significant human efficacy data generated in our first NLC study hold great promise as a new treatment for the millions of individuals in the United States who currently have no space on effective therapeutic options. These recent results certainly encourage us to look beyond exercise associated cramps and nocturnal leg cramps to spasms and spasticity in MS and other neurological diseases because we believe they are common underlying neurobiological mechanisms at place. With our ongoing and future clinical development programs, we expect to find the impact in this novel therapeutic approach to control neuronal hyper-excitability and prevent muscle cramps and spasms in different clinical setting. I will now hand the call to Marina to discuss the progress of our consumer efforts.

Thanks, Tom. Good morning everyone. We have made great strides in the development of our cornerstone consumer product and we are prepared to launch within the next few weeks. We have created a truly unique consumer brand based upon the breakthrough scientific insights by Nobel Prize winning neuroscientist and Endurance athlete Dr. Rod MacKinnon. As Tom just mentioned, our sports beverage is the first and only consumer product that we are aware of that has demonstrated statistically significant efficacy in mitigating muscle cramps in rigorous double-blinded scientific studies. Flex Pharma’s goal is to take athletes beyond the traditional mindset that exercise associated muscle cramps are caused by a problem with the muscle. Drawn on Dr. MacKinnon’s Nobel Prize winning research, the product is designed to stimulate sensory fibers and consequently reduce hyper-excitability in motor neurons in the spinal cord leading to a rapid reflex like suppression in muscle cramping. This novel mechanism of Chemical Neuro Stimulation is allowing us to define a whole new category in sport nutrition, neuromuscular performance. Through our itsthenerve prelaunch campaign and website we have been educating consumers about our product facility in synchronizing communication between the nerves and muscles allowing the muscles to function properly, thereby improving neuromuscular performance. Let me share with you a few highlights of where we are. Our product optimized for efficacy and tolerability is scientifically proven to prevent and treat muscle cramps. We have continued to receive positive feedback from our Alpha athletes who have been training with our very typical product. Our packaging is powerful, our pricing strategy is in place, our selling strategy is clear, our supply chain is ready, our marketing plan is based on building the cult. The product messaging and name to be revealed at launch is provocative, bold, and irreverent. The proprietary packaging is distinctive and powerful appealing to our Alpha athlete target audience. Recall that in launching a co-brand the strategy is to focus on a small highly defined target audience ultimately converting them to believe there is irregular users. Establishing a co-brand takes time and patience to drive usage and adoption among our target consumers, for us it’s the Alpha athlete. We estimate that over 8 million Endurance athletes cramp at least once a week from sports and exercise. Once established, we can then broaden to the larger Endurance athlete audience. Then we can expand from co-brand to a life style brand with broader appeal. Companies like Uber, Clif Bar, and Red Bull have all employed a co-brand approach successfully showing a Hockey stick growth rate once the product reaches the mainstream audience. We expect our price to be north of $5 a bottle to reflect the unique premium value our product delivers and we will unveil our product pricing at launch. The launch campaign will raise awareness of our scientific breakthrough to drive credibility of the brand, leveraging a slate of scientific and athletic sports people. As far as marketing and publicity, we continue to take a strategic approach leveraging word of mouth, digital media, social media, and PR activity. We will actively manage influential social media channels. Our co-marketing plan will utilize digital and print media to drive awareness in trial among endurance athletes. The pre-launch digital social media campaign to educate earlier adopters successfully resulted in some of the most influential endurance sports publications showcasing the science behind our discovery. You may recall our scientific breakthrough was featured in the November print issue with Outside Magazines which is the leading publisher for active lifestyle enthusiasts. Articles have also been published in Competitor, Runner’s World, Bicycling, and Running Time among others. We have identified specialty retailers who cater to our initial target audience of cyclists, marathoners, and triathletes. We have selected Boston, Boulder, and LA for our limited launch. Boston representing the intersection of brains and brawn, Boulder the epicenter of endurance athletes, and LA for the buzz factor. We expect to begin selling our sports beverage in specialty retail stores in these three markets and on our branded website within the month. I will now hand the call to Kathie to provide further color on the operational aspects of the business.

Thank you, Marina. We recently completed the first full scale production run of our sports beverage, it is low calorie, natural, and certified USDA organic non-GMO, gluten free, and Kosher. As Christoph mentioned, our products has also been certified for sports by NSF which tests more than 230 prohibited and banned substances. The NSF certification is particularly important because it allows professional athletes to take our products, pro-teams from the NFL, NHL, MLB, and NBA, have been sampling the product and we continue to have more head trainers reach out to us. As you know, we have been seating a beta version of our consumer products with athletes establishing credibility with the endurance sports community and building demand with our target consumers. This sampling program with endurance athletes, Olympians, and professional teams is providing momentum for the official launch of our consumer products. The program Beta for Alphas has received strong interest. Alpha athletes are asking for more products and many testimonials have been posted on our blog. Our website itsthenerve.com has over 30,000 subscribers and we will be communicating with this motivated group about the upcoming launch over the next month. As Marina mentioned, our launch campaign will be supported by endorsements from endurance athletes that are highly respected among their peer group such as beloved IRONMAN Triathlete, Crowie Alexander, and Olympic Marathon contenders Shalane Flanagan and Amy Cragg, two of the three women who will be representing the U.S. in Rio in that event. At our Boston Marathon Expo Booth Shalane Flanagan shared her experience with our products and signed autographs for the long line of fans that was 50 plus feet for over an hour. Many other athletes have sampled our product and reported various additional benefits such as reduced muscle soreness and we continue to explore these potential neuromuscular performance benefits. We will be driving demand and influence of advocacy through education and strategic sampling at 10 full events in key markets. Our first experiential launch event will be in Boulder. Given our target audience we will also be acting at major IRONMAN events, other endurance competitions such as the Leadville 100 Mountain bike race and relevant medical and sports conferences including the upcoming American College of Sports Medicine in June. Our presence in specialty retail locations will drive word of mouth amongst the Alpha athletes at frequent these stores. However, we expect the majority of sales to come through our branded websites as this is the way many consumers shop today. For our branded website, we are partnering with top care fulfillment and transaction vendors for seamless integration and high quality service. We will offer a special price trial pack of our product on our branded website to incentivize first time usage. In summary, the team has done an extraordinary amount of preparation to launch this new category in sports nutrition. Our composition is strong and sharp, we have a clear launch strategy, and we are prepared to execute upon our plan. Our goal is to build the consumer brands with long-term sustainable growth. We will be learning a great deal over the next several months and look forward to updating you next quarter on our progress. Hopefully many of you will try the product when it’s available. I will now turn the call back to Elizabeth.

Thank you, Kathie, and Andrea we are ready to open up the call for Q&A, joining us on Q&A will be John McCabe, our VP of Finance. So when you are ready Andrea please queue up the questions.

Thank you. [Operator Instructions]. Our first question comes from the line of Joe Pantginis with ROTH Capital Partners. Your line is open.

Good morning everyone thanks for taking the question and thanks for the detailed update. Two questions if you don’t mind, first I would like to focus on the NLC study. So may be Tom with regard to the subset of patients that you mentioned that had very high responses, is there anything that you can point to with regard to the phenotypes of these patients or their neurological status or the level of their underlying disease to point to why they might have responded better?

So we’re still analyzing that, we do not have a distinct responder profile and we believe that there is actually a quite inform response across the whole population related to the frequency of cramp at baseline. We think that this bodes very well for future development, we know from other CNS drugs that there are certainly subsets that have these pronounced responses and I direct you to the Lancet paper that was published in 1997 on nocturnal leg cramps looking at Quinine to familiarize yourself with some of the responder analyses that are commonly applied to such datasets.

That’s helpful, thank you. And if I could just switch gears quickly to the commercial side, so heard you say I believe you completed your first full scale production run. Is it possible without giving anyway, any competitive secrets away, any insight into your capacity and your how you’re looking to distribute the drug once you the drink once you have it ready to go, what’s your distribution channels look like?

We have our distribution set up and for the ecom we will be using Amazon prior fulfillment. But we have produced sufficient quantities to meet our high sales scenarios to ensure we have enough bottles on hand to even if we deem that in excess. We want to make sure we have plenty of product on hand, no stock of cocktail, an important product.

Thank you. Our next question comes from the line of Mara Goldstein with Cantor Fitzgerald.

Thank you. Thanks for taking the question. If I could just go back to the question around the subset, I mean there was discussion early in the call about our subset were having a pronounced benefit. So may be if you could just elaborate a little bit on what you mean by pronounced benefit. Was this some element of particular outcomes measurements that were looked at but do they have do with cramp frequency or was it secondary, if you can kind of help us out with that that would be great. And then just dovetailing on that how does that help you inform the next phase of the clinical development program in these three separate indications once we get the populations?

Yes, absolutely. So in the Quinine field traditional measure has been to look at the frequency of cramping over two-week period and as was found in the Quinine studies there are some individuals that will respond very, very well and others modestly and others not so much. So this is a common effect seen across the board with many CNS drugs and that’s really what we have observed as well. As we kind of pointed out earlier, there is a subset that seems to have a very pronounced response, so we have 12% of our patients in our NLC study that had a 75% reduction in cramp frequency and there was zero on the placebo side. So that’s a very good indicator that we’re having similar efficacy across the board. I think that in the future NLC studies this may very well be a clinical endpoint that the FDA could agree to however it’s been a long time since the FDA has discussed these types of endpoints with sponsors. So I expect that there will be a vigorous discussion about this endpoint and other endpoints that could be applied in NLC studies.

Okay. And if I could just ask on the trials that have contemplated in the different patient population, is it expected that the outcome measurements will be the same?

No, you’re talking about the MS and ALS studies?

Right.

Obviously there are sort of endpoints in two different domains that we’re looking at very carefully. The frequency and severity of cramps and spasms these are slightly different in nature from the cramps that occur in athletes and nocturnal leg cramps, patients which are neurologically healthy patients or neurologically healthy individuals. And then the other aspect that we’re particularly interested in because this is a vexing problem in the clinic is the control of spasticity. So certainly spasticity is that additional dimension that we’re really focusing on and we’re hopeful that we will see some effects there because as we know spasticity is an expression of neuronal hyper-excitability as well. And Mara, you can look at the Ampyra approval minutes from the FDA that obviously Tom led that as Chief Medical Officer for the kind of endpoints that are interest to us.

Okay, I appreciate that. And if I could just ask also the oral dissolve tablet, Tom I think you said anticipating commercial formulation, so should we take it that the formulation that will be used in the next round of clinical studies will not be faced with the go-to-market formulation?

Well we’re getting as close as we possibly can to the commercial population in formulation. So obviously we’ve made big strides in the last few months to define what is really the appropriate dose and what is the best possible ODT tablets that we can utilize, I’m not saying that this is going to be the final formulation but we’ve made great strides in that direction and we anticipate starting both the NLC study and the ALS study with such an oral dissolving tablet.

And Mara it’s a great question, you will appreciate of course, we have this unique opportunity to show efficacy in humans the electrically-induced cramp model with what could one day be our commercial product on the regulated side. And so, it’s really quite a unique advantage this company has compared to most other companies.

Yes okay thank you. I will stop there and get back in the queue; I will let somebody else ask a question.

Thanks Mara, please do reenter the queue though.

Thank you. And our next question comes from the line of Chris Howerton with Jefferies. Your line is open.

Great, thanks for taking the questions. I guess just a follow up on Mara’s previous question in terms of dosing and potency, what can we kind of learn in terms of the legacy formulation of TRP stem and then the FLX-787 single molecule that you used in electrically-induced model and then the dissolving tablets that might used at the studies a bit, kind of similar in concentration or is that changed overtime?

It’s a great question, I mean it’s pretty amazing what Tom and his team has done over the last year we have gone from a mixture that 50 milliliters of completely undefined from a pharmaceutical perspective to a tiny little pill with low-double-digit milligram single GMP purified molecule with confidence that we can have human efficacy with it. So it’s been quite a path from and a very different product.

Thanks guys. So it’s just I guess it’s fair to say that active molecule is probably about the same delivery in total quantity but currently the concentration has increased as you get well small and smaller?

Yes I think what we’ve gone from is a mixture of a number of different potentially active molecules at quite low doses to a single purified molecule at a low dose. So it’s actually, I think on both of those activities we have improved it.

Got it, okay. All right and then just a quick one in terms of operating expenses moving forward now with the launch coming up probably towards the end of this month. See if you can provide any guidance in terms of trajectory of stents and may be anything else on that anything? Thanks.

Hi Chris, this is John. So well I’d say is our quarterly burn could be lumpy but we have cash to take us through the middle of 2018. So that’s the extent of the guidance that we are going to provide at this point.

Okay. All right. Well thanks for taking my questions and congrats and good luck on the pre-launch.

Thanks, Chris.

Thank you. [Operator Instructions]. Our next question comes from the line of Mike King with JMP Securities. Your line is open.

Hi guys, good morning. Thanks for taking the question and thanks for all the candor. Lot of my questions have been answered, I just was wondering couple of questions on Quinine. Has anybody ever elucidated with actual mechanism of action is of Quinine in the setting of NLC?

We’re really not sure but we think it probably acts as the motor in place in the muscle itself.

It’s given a very large doses as you’re probably aware, which is probably the issue with the side effect.

Okay. Do we know what if it has any activity on TRP channels at all?

There is not good data arguing that is a potent or selective TRP agonist. And of course we believe that our drugs act topically in the oral settings and are non-systemic and in fact we have evidence that there is no systemic exposure in humans at the doses we’re talking about. So you would have to argue this is probably quite a different approach and mechanism.

Okay. Thanks for that. And then just as far as our scripts or sales of Quinine tracked at U.S. markets. And if so do you know can we get a sense of perhaps end market demand for Quinine?

In the UK, it’s over 4.5 million prescriptions a year that the fifth population of the United States with well over 4 million prescriptions a year. In the United States prior to being banned it was well over 2 million prescriptions a year, so anyway you look at it; it is a very, very large market.

Must be a lot of insomnia in the UK. And just finally the when you begin single tablet formulation, will we be made aware of sort of the selectivity of that molecule or will you keep that under wrapped for a bit until IP issues and all that other good stuff. Thank you.

Yes no it’s such a great but we expect the TRPA1 and V1 agonist and we know you are a intelligent student of the literature. So I’m sure you can have a pretty good intuition as to which class of molecule it is in. We have method of treatment claims that we believe will protect us into the 2030s. So it is a very long patent life ban for an agent that we think could get approved in the United States in the near-term. And so we probably won’t say the exact nature of that molecule for a bit here but at some point you will see patents related to this of course have been off transactions.

Thank you. And we have a follow-up question from the line of Mara Goldstein with Cantor Fitzgerald. Your line is open.

Thanks very much. Can you just remind us what the shelf life of the consumer beverage is?

12 months but we will be extending that to 18.

Thank you. This concludes today’s Q&A session. I would now like to turn the call back over to Christoph Westphal, CEO, for any closing remarks.

Great, thank you so much. At Flex Pharma, as we work to define the positive impact of Chemical Neuro Stimulation on reducing cramps and spasms in several important settings, we are excited to be creating a leading neuromuscular company built on our strong foundation with excellent people and great science. And I would just like to invite everyone who is on the phone today to go to itsthenerve.com, you can sign up and obviously we’re getting near to launch here. Thank you very much for joining us this morning.

Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program and you may all disconnect. Everyone have a great day.