Tram Bui - The Ruth Group Dave Gonyer - Chief Executive Officer Matt D’Onofrio - Chief Business Officer Marilyn Carlson - Chief Medical Officer.

Yale Jen - Laidlaw & Company David Buck - B. Riley FBR.

Greetings. And welcome to the Evoke Pharma's Fourth Quarter and Full Year 2017 Earnings Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation [Operator Instructions]. As a reminder, this conference is being recorded.

I would now like to turn the conference over to your host Tram Bui of The Ruth Group. Thank you. You may begin..

Good afternoon. And welcome to Evoke Pharma’s fourth quarter and full year 2017 earnings conference call and audio webcast. With me today are Dave Gonyer, Evok’s Chief Executive Officer; Matt D’Onofrio, Chief Business Officer; and Dr. Marilyn Carlson, Chief Medical Officer.

Earlier today Evoke issued a press release announcing financial results for the three and 12-months ended December 31, 2017. We encourage everyone to read today’s press releases, as well as Evoke’s annual report on Form 10-K, which is filed with the SEC.

The Company’s annual report and press release are also available on Evoke’s Web site at www.evokepharma.com. In addition, this conference call is being webcast at the Company’s Web site and will be archived there for future reference.

Please note that certain of the information discussed on the call today is covered under the Safe Harbor provisions of the Private Securities Litigation Reform Act. We caution listeners that during this call, Evoke’s management will be making forward-looking statements.

Actual results could differ materially from those stated or implied by these forward-looking statements due to risk and uncertainties associated with the Company’s business.

These forward-looking statements are qualified by the cautionary statements contained in Evoke’s press releases and SEC filings including its Annual Report on Form 10-K and subsequent filings. This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, March 7, 2018.

Evoke undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call. With that, I would now like to turn the call over Dave Gonyer..

Thanks, Tram and thank you all for joining us this afternoon. For the last couple of months, we've been and continue to be hard at work on completing our NDA for Gimoti and submission to the FDA next quarter.

And this past year has been critical to bringing us to this point as we’re very focused on the initiation and completion of our pivotal comparative exposure pharmacokinetic or PK study for Gimoti. Based on the communications with FDA, we believe successful completion of this study provided the final set of clinical data needed to complete our NDA.

The PK study results that were announced in October were in line with our previous communications with the agency and provided us with what we believe is an optimal dose for NDA submission. In addition, we have recently discovered a sex-based difference and drug exposure in healthy volunteers given the same dose of metoclopramide.

We believe this new information can be used to provide a more targeted treatment to those suffering from gastroparesis, specifically women who represent 80% of the current market. These sex-based differences were also seen when data from previous PK studies were reanalyzed.

Such differences in metoclopramide exposure based on sex have not previously been reported, we’ve submitted new patent applications related to Gimoti. Before I share more details on these clinical findings, I would like to briefly revisit our path forward with FDA, as well as the top-line results of the PK study.

During the past year, we’ve met with FDA several times to clarify and confirm our path toward 505(b)(2) NDA submission, as well as the acceptability of our data from the PK study to complete submission.

This study was an open-label, 4-way crossover that enrolled 108 male and female healthy volunteers who each received one Reglan Tablet dose of 10 milligram, which is the reference listed drug and three different doses of Gimoti.

The study successfully identified not just one, but two doses of Gimoti based on criteria that included a 90% confidence interval for the ratio of area under the plasma concentration curve or AUC falling within the equivalence range of 80% to 125% of the reference listed drug.

While maximum observed plasma concentration or Cmax was slightly lower than the reference listed drug due in part to the different route of administration, these results were in line with our expectations discussed with FDA in previous meetings.

As we’ve mentioned in the past, the federal regulation states two drugs may be equivalent in the extended absorption but not rate of absorption and still be considered pharmaceutical equivalence or alternative. An example of the recently approved product is nasal naloxone where the Cmax or the nasal spray exceeded the Cmax of the injection.

Traditionally, if a new drug exposure exceeds the upper range of the confidence interval, the reference listed drug additional safety data is needed. The results that fall below the lower range, additional proof of efficacy is needed.

Cmax for the selected Gimoti dose was slightly below the lower bound of the confidence interval, Phase 2 and 3 efficacy data simply had specifically showed efficacy in women at doses to similar to or lower than our proposed to be marketed dose will be submitted to the NDA in support of a proposed Gimoti dose.

Overall we achieved what we set out to do in the PK study and the top-line results were in line with our expectations. Now after additional analysis of the PK data, we recently uncovered a new finding that there were differences in exposure between men and women given the same dose of metoclopramide.

More specifically, they were statistically significant with different -- significantly lower AUCs in men as compared to women and that this difference was not explicitly attributable to the subject's body mass index or weight.

Interestingly, similar sex based differences were observed in a previous healthy volunteer study irrespective of the route of administration either nasal, oral or IV. We believe this difference may explain part of the efficacy differences noted in our prior Phase 2 and Phase 3 trials.

Based on these findings and another pre-NDA meeting with FDA, we plan to submit the NDA for female-only indications based on the dose in women with equivalent exposure to the reference listed drug or Reglan tablet.

We'll also be submitting supporting efficacy and safety data from our Phase 2 and Phase 3 trials where efficacy was demonstrated as doses similar to or lower than the proposed to be market in Gimoti does. At the recent FDA meeting, we discussed and clarified the agency's expectations of items being prepared for inclusion in the NDA for Gimoti.

Based on these discussions with the agency, our NDA will include proposal for a risk management strategy.

At this time, we've not finalized developments of the risk management strategy for Gimoti as there are varying levels of requirements that may include a medication guide similar to the Reglan tablet and other element, such as a communication plan and an implementation plan designed to ensure safe use, as well as a time table for submission of post-market assessment after risk management strategy is approved.

The NDA will also include a post-approval study designed to confirm prior safety findings and rule out possible differences and side effects compared to Reglan tablets over the approved duration of tablet use, which is two to eight weeks for diabetic gastroparesis.

As discussed with FDA, we expect to finalize the details of the post-marketing safety study with FDA during the NDA review process. Given the new sex-based exposure data and the need to fully incorporate the feedback received at the recent pre-NDA meeting, we expect to file the Gimoti NDA in the second quarter of this year.

We continue to work with [CRO], our regulatory consulting and contract research organization to finalize the NDA for submission.

[CRO] worked in a number of other successful NDA submission that have led to FDA approval of GI products, and we’re leveraging their experience of their team in a preparation of our application and feel confident in their abilities to complete the successful submission.

And in parallel to the NDA activities, we’ve continued our conversations with Syneos Health formally inVentiv Health to prepare plans for commercial infrastructure as we look ahead to the potential commercialization of Gimoti in the U.S. pending the potential approval from FDA.

Syneos provide the full range of services, including sales reps, commercial management, marketing and advertising. Once we file the NDA, we anticipate that these efforts will ramp up and we'll provide additional updates on our progress in the coming quarters. Now, let me turn it over to Matt to discuss the marketing aspects and the financials. Matt..

Thanks Dave. Once again, thank you all for joining us this afternoon. Let me start off by laying out some important commercial aspects of Gimoti product opportunity. Recall that gastroparesis effect of the 12 million to 15 million in the U.S. and as noted earlier by Dave, it's predominantly women with only a fraction currently seeking treatment.

Of the 2 million to 3 million patients who receive treatments, about half to two thirds received metoclopramide oral to help with those symptoms. This is the only FDA approved medication in the U.S. for treating symptoms of gastroparesis.

Currently, about 4 million subscriptions of all metoclopramide are written each year and the majority of those are to specifically treat gastroparesis. These prescriptions are without any promotion or other marketing as the product has been generic for many years. Gimoti conserve a critical aspect of treatment for these patients.

First, gastroparesis means that a person’s stomach is failing to move its contents in the small intestine for absorption. This is for nutrition, hydration and medication absorption. Unfortunately for patients, the only FDA approved outpatient treatment is in an oral pill.

That pill can sit in the stomach for hours or sometimes days without being moved into the intestines due to the disease even when the patient may be compliant in taking their medication.

This concept is described by the FDA in their 2015 Draft Guidance for development of gastroparesis medication as it relates to erratic absorption of diabetic medication in these patients. Gimoti addresses this specific issue about directly absorbing the medication through the nasal mucosa.

Second, this issue of absorption has further compounded by the frequency of vomiting in these patients. Physicians in our market research have directly described their need to know a medication is actually being absorbed if it’s prescribed and taken.

For those patients that don’t find relief, they unfortunately often are unable to get the needed hydration and nutrition to help and end up in a hospital. Once there, they receive various treatments, including IV metoclopramide.

The IV treatment is effective but given the severity of the situation, the average gastroparesis patient stays in hospital for six or more days. The cost is significant and it drives a need for new and improved options to help these suffering patients.

We’re very excited to move Gimoti closer to market and believe strongly that the benefit it delivers are meaningful step to a better care of these gastroparesis patients. As to moving the product closer to market, let me start with the announcement just this last Monday regarding the FDA PDUFA fee waiver approval.

The waiver allows us to avoid approximately $2.4 million fee for a new drug application and enables us to continue focus our resources finalizing the NDA. We’re very excited to have received the support from the FDA. And given the magnitude of the fee for emerging company, this is very important for us.

Along with this, we remain conservative with our expenditures and would like to reiterate our cash, front cash runaway will last until October 2018 and we remain opportunistic in our evaluation of capital and other strategic transactions.

Having said that, let me take a deep dive in the three month results and the fourth quarter -- for the fourth quarter 2017.

In the fourth quarter, we reported net loss of $308,000 or $0.02 per basic share, based on weighted average shares outstanding of approximately 15.4 million shares as compared to a net loss of $1.5 million or $0.12 per basic share based on approximately 12.3 million weighted average shares outstanding for the fourth quarter of 2016.

Research and development expenses totaled approximately $1.6 million for the fourth quarter of 2017 compared with $1.5 million for 2016. For the fourth quarter of 2017, general and administrative expenses were approximately $1 million compared with approximately $822,000 for the fourth quarter of 2016.

Total operating expenses for the fourth quarter of 2017 were approximately $2.7 million compared to total operating expenses of approximately $2.3 million for 2016. And now for the results of 12 months ended December 31, 2017.

For the full year ended December 31, 2017, the net loss was approximately $12.2 million or $0.82 per basic share based on approximately 14.9 million weighted average shares outstanding.

This compares to a net loss of approximately $10.7 million or $1.15 per basic share based on approximately 9.3 million weighted average shares outstanding during the year ended December 31, 2016. Research and development expenses during the year ended December 31, 2017 were $7.1 million compared to $7 million in the prior year.

General and administrative expenses for the full year of 2017 totaled $4.1 million versus $3.6 million for the full year 2016. Total operating expenses for the year-ended December 31, 2017 were approximately $11.2 million compared to $10.5 million for the full year of 2016.

Included in the net loss, for the fourth quarter of 2017 was a gain of approximately $2.3 million due to the change in the fair value of the warrant liability. And for the year ended December 31, 2017, there was a net loss due to the change in the fair value of the warrant liability of approximately $1 million.

The warrant liability is subject to re-measurement at each reporting period and we recognize any change in the fair value of the warrant liability and the statement of operations.

We anticipate that the value of the warrants can fluctuate from quarter-to-quarter and as such fluctuations could have a material impact on our financial statements from quarter-to-quarter and year-to-year. Finally, turning to our balance sheet. We ended the year with cash and cash equivalents of $7.7 million. That concludes our prepared remarks.

We now like to open the call to questions.

Operator?.

Thank you. At this time, we will be conducting a question-and-answer-session [Operator Instructions]. Our first question comes from the line of Yale Jen from Laidlaw & Company. Please proceed with your questions..

Good afternoon and thanks for taking the questions. And congrats for the progress. You mentioned there are two key pay value you determined within the range. And ultimately, you also have this chosen female instead of both sexes as the one for filing.

Was that -- one of the value PK value also the same – is the one you chosen for the female or there is additional one or could you comment anything on that?.

Yale, this is Dave thanks for the question, hope you're doing well. We did have two different I think you meant doses that we saw on the PK trial that we saw effective in both men and women. We did find a different dose effective in just women and that's the dose that we'll be going forward with..

And theoretically, I think you may not want to talk specific.

Would you like to have a higher or lower dose for that matter or is that something you may not review at the moment?.

With the dose we've seen -- I'm not sure that the higher or lower dose would make a big difference to us. We just want the most effective dose for patients and the safest dose for patients..

And maybe one or two quick questions. You mentioned there is a risk management program to be discussed with the FDA.

Do you anticipate that will be significantly different from the oral drug or you think overall that could be similar at least or in principle?.

Let me see if I can answer that. When the oral dissolving dissolution tablet was approved in 2009, it had elements of a risk management strategy for the first few years. We anticipate that Gimoti will have something that will be similar..

And then may be last question here is that you also indicate that FDA will ask us to do a post marketing studies.

And should we assume that that will be something you would thought it next year get approved or there is something you may even contemplate some details in this year?.

It will take us a while to come to final agreement on the design. The agency asked us just to propose something and they will give us some feedback. So we’ll have some ongoing dialogues during the NDA review. And so it will be some time after approval, but we don’t have timing on that yet..

Our next question comes from the line of David Buck from B. Riley FBR. Please proceed with your question..

Just a couple of questions. First, in terms of the timing of the submission of the Gimoti NDA in the second quarter. At this point, so you are expecting this to be fairly early in the second quarter or unknown at this point? And I guess a question for Dave and/or Matt.

If you look at the planning for -- potentially going to get your sales force with Syneos Health. And given you do have a little bit more runway with cash but cash conservations actually concern. Is there any parallel discussion with potential partners outside of do-it-alone strategy with building your own contract sales force? Thanks..

I’ll answer the first question and then Matt can discuss further on the second one. We’re working very hard as I had mentioned with [CRO] to complete the NDA in a timely fashion. We haven’t given guidance specifically on when in the second quarter. We as a team obviously would like to do it sooner rather than later.

But we want to make sure we do it right as well. So we’re taking the necessary steps to get a filing that will be accepted by FDA. Hope to have it done sooner rather than later..

And if I can follow up maybe Dave for the FDA meeting and the submission that’s now pushed back a quarter.

Were you’re surprised by the -- I guess you were, were you surprised by the PK filing and finding rather on women versus men and is that why there is a delay in terms of the submission versus what we’d expect, still first quarter announcement but absolutely pushed out one full quarter..

It was very surprising where we found that and then after molecules done on the market for nearly 40 years and no one has discussed any level of differences between men or women. And then as we founded in ’06, we said well let’s go back and look at another PK trial we did in 2008.

And we saw some similar differences with the molecule and that included the oral, the IV and the nasal spray. So when we saw there is something going here and found it very surprising in fact enough to be able to file IP on it as well. And may have help explain some of the results we've had in our past clinical trials with efficacy.

We haven't seen efficacy in men in the trials we've done. So perhaps this is a reason why we don't know for sure but we can speculate.

Matt, you want to answer that?.

And in terms of your other question regarding potential partnering. We said in the past that we have been engaged in conversations with various organizations about partnering or otherwise other strategic opportunities. We haven't stopped that so we continue to hold those conversations as we go.

And remain open to the right scenario to conduct such a discussion..

Our next question comes from the line of [Paul Burns] from Northland Securities. Please proceed with your questions..

So this goes back to the Cmax of the two doses being slightly below bioequivalency in the prior PK study, combining with your sex-[based] discovery. So you run an additional PK Trial at a select single dose to women.

When would we expect to see top-line readout of that?.

So we're not doing another PK trial in just women..

So you'd be able to extrapolate some existing data in order to make that -- the completion of the NDA submission then?.

Correct..

Thanks for clarification. Thank you..

This is in part why we feel very confident we'll be able to submit in Q2..

Our next question comes from the line of Yale Jen from Laidlaw & Company. Please proceed with your questions..

Thanks for taking the follow up question. Just curious as to what the female specific only if PK information as well as the potential getting into some IP from this time.

Do you anticipate this overall strengthen your position in terms of getting approval, as well as potentially in the marketplace given that you have potentially have those claims on the label?.

I don't know that it changes the approval in and of itself, but it's still -- it's basically submitting the appropriate dose appropriate for women. And that really doesn't change what it was for women only or for men and women together.

But in terms of IP, we do believe that it's a very novel concept specifically having appropriate and specific dose for women only. And then what we’ve assumed to be something very different based on our calculation a different dose, a higher dose for men. So given that, we do believe that perhaps very likely to be allowed.

And if so, we'd be able to cover the explicit dose used in the label. And if that is allowed, it would be orange book listable and we believe to be very potent as protecting the product for 20 year starting greatly just recently..

[Operator Instructions] That does conclude our question-and-answer session. I will now turn the call back over to management for closing remarks..

Thank you. I think the market research and the physician interviews support our belief that existing treatment options for diabetic gastroparesis remain inadequate, and there’s a high level of interest in effective outpatient options for managing patients’ gastroparesis symptoms.

If Gimoti is approved, female patients and healthcare providers will have access to outpatient therapy that can be administered and absorbed even when a patient has delayed gastric emptying and is experiencing nausea and vomiting.

We’re optimistic about the novel treatment options for this very significant female population that is still very underserved by the existing gastroparesis treatment. And I would like to thank everybody for joining us today and we look forward to some continued updates over the next several weeks. Thank you..

That concludes today’s teleconference. You may disconnect your lines at this time..