David Burke - IR, The Ruth Group David Gonyer - President and Chief Executive Officer Matthew DOnofrio - EVP, Chief Business Officer, Secretary and Treasurer.

Irina Koffler - Cantor Fitzgerald Ken Trbovich - MLV Yale Jen - Laidlaw Ben Haynor - Feltl and Company.

Greetings and welcome to the Evoke Pharma fourth quarter 2014 earnings release conference call. [Operator Instructions] I would now like to turn the conference over to Mr. David Burke of the Ruth Group. Thank you, Mr. Burke. You may now begin..

Good afternoon, and welcome to Evoke Pharma's fourth quarter 2014 financial results conference call and audio webcast. With me today are Dave Gonyer, Chief Executive Officer; and Matt D'Onofrio, Chief Business Officer. Earlier today, Evoke issued a press release announcing financial results for the three months and full year ended December 31, 2014.

We encourage everyone to read today's press release as well as Evoke's Quarterly Report on Form 10-Q, which was filed with the SEC today. The company's Annual Report and press releases are available on Evoke's website at www.evokepharma.com.

In addition, this conference call is being webcast through the company's website 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 management will be making forward-looking statements. Actual results could differ materially from those stated or implied by these forward-looking statements due to risks 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. This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, March 4, 2015.

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 to Dave Gonyer.

Dave?.

Thank you, David, and thank you all for joining us this afternoon for our call to discuss Evoke's financial results for the fourth quarter of 2014, accomplishments for the year and an update on our outlook for the company going forward. Overall, 2014 was a successful year for Evoke.

We made significant headway towards potential FDA approval and commercialization of EVK-001, our novel intranasal delivery and reformulation of metoclopramide for the treatment of women who suffer from diabetic gastroparesis.

One of the most significant milestones we achieved was the initiation of our Phase 3 trial, with the first patient having enrolled in the second quarter of last year. Based on our past conversations with the FDA, this trial is the last of two remaining studies needed to satisfy their requirement for our new drug application.

The other reported trial, a thorough QT study was initiated and successfully completed late last year. This study assess the effect of the QT interval for cardiovascular risk associated with the use of our formulation of metoclopramide in subjects who were given therapeutic and supratherapeutic doses.

The study found there to be no cardiovascular safety issue associated with EVK-001. We are unaware of any other thorough QT study performed with metoclopramide, which makes EVK-001 the only metoclopramide formulation that has been proven in a controlled study not to have QT effects.

We were also very active in our first year as a public company, educating the market about gastroparesis and why an intranasal delivery of metoclopramide, which is the only molecule currently approved by the FDA for gastroparesis, is a very attractive option for patients with this condition.

While this is sometimes considered an overlooked disease, there has been a considerable amount of renewed awareness and interest, due to the growing incidents of the number one known cause of gastroparesis symptom, diabetes.

There is a large growing market opportunity for an effective treatment for gastroparesis, just based on approximately 4 million prescriptions of the oral form of metoclopramide written by healthcare providers each year.

Given that this is a disease where the stomach has slowed or erratic motility doesn't properly pass food or drug into the small intestine to be absorbed, we believe EVK-001 has the potential to become new standard of care by providing a drug that bypasses the stomach.

As an intranasally delivered product, this formulation of metoclopramide enters directly into the blood stream through the nasal membrane, compared to the current oral form, which was first passed through the stomach in order to be absorbed.

We want to make sure that gastroparesis patient and the physicians who treat this disease as well as the investment community understand the inherent benefit of EVK-001, and how it can evolve the treatment paradigm of gastroparesis, and we are working to deliver that message.

With regards to our Phase 3 clinical trial, we have continued to progress enrollment. As we stated last month, we are expecting to complete the enrollment in the second half of this year. While this is behind our original plan of mid-year, we don't view this as having a significant impact on the timeline for FDA approval and commercialization.

An important point to remember is that gastroparesis is a disease, in which patients experience flare symptoms such as nausea, vomiting, bloating or pain. Unfortunately, these flare ups are unpredictable and we must identify patients at the appropriate time to be able to enroll them into the trial.

We believe that finding qualified patients during flare ups is important to obtain the best data possible to prove a treatment benefit for EVK-001. While we have updated timeline for our clinical trial enrollment in the second half of the year, we remain well funded for the duration of 2015.

To summarize, we are pleased with what we have achieved to date and with the long-term outlook for Evoke. We are seeking to provide a clinically significant benefit to the health of gastroparesis patients, which based on the patient population has a very attractive market opportunity.

We are well on our way to accomplishing this goal, [completing] [ph] the final trial. We continue to work diligently toward our goal of FDA approval of EVK-001 and developing a successful commercial product to address this unmet market need. Now, let me turn the call over to Matt D'Onofrio to review our financials..

Thanks, Dave. In the fourth quarter of 2014 we reported net loss of $2.9 million or $0.48 per share based on weighted average shares outstanding of approximately 6.1 million. This compares with a net loss of $1.6 million or $0.27 per share based on approximately 6 million weighted average shares outstanding for the fourth quarter of 2013.

The increase was due to our ongoing Phase 3 and our thorough QT trial we completed in December. R&D expenses in the fourth quarter of 2014 were $2.2 million, up from $636,000 in the fourth quarter of 2013.

The year-over-year increase in research and development expenses was related to increase in clinical trial cost associated with the Phase 3 and the thorough QT study for EVK-001. General and administrative expenses in the fourth quarter of 2014 were approximately $738,000 compared with approximately $944,000 for the fourth quarter of 2013.

This decrease was attributable to cost associated with public reporting requirements following the company's initial public offering in 2013. Total operating expenses in the fourth quarter of 2014 were $2.9 million, up from $1.6 million in the fourth quarter of 2013.

For the year ended December 31, 2014, we reported net loss of $13.2 million or $2.20 per share based on weighted average shares outstanding of approximately 6 million. This compares with a net loss of $2.8 million or $1.20 per share based on approximately 2.4 million weighted average shares outstanding for the prior-year period.

R&D expenses during the year ended December 31, 2014, were $10 million, up from approximately $957,000 in the prior year. General and administrative expenses for the full year of 2014 totaled approximately $3.2 million compared to approximately $1.6 million for the full year of 2013.

Total operating expenses for the year ended December 31, 2014, were approximately $13.2 million versus $2.6 million for the full year of 2013. And looking at our balance sheet, as of December 31, 2014, we had cash and cash equivalents of $14.2 million, which we expect to support our operations through 2015. That concludes our prepared remarks.

And we'll now like to open the call to questions.

Operator?.

[Operator Instructions] Our first quarter question is from Irina Koffler of Cantor Fitzgerald..

So in early February you guys put out a press release that figured 74 patients enrolled out of the 200.

So just wondering how many you have now? And also what efforts you've been taking to drive enrollments further and your assessment of whether or not you think it’s working and your initiatives are working?.

You're correct. We updated the market on enrollment in February with 74, and as you know with any clinical trial you have times where it's not only consistent, it’s up and it’s down.

Our recent initiatives have begun to prove effective, and we've taken a pretty strong push on social media, Facebook, Google ads and are also trying some other social media as well, as it relates to clinical trials specifically. And we are just now seeing that outreach and that present having effect at the site.

We're getting a lot of feedback from the sites that they are being contacted by patients. So we're very excited to hear that. I think going forward we will continue to update the shareholders and investment community as appropriate..

And then in terms of spending, does the spending sort of follow the enrollment.

So as you suddenly get a big bolus of patient you're going to have cut checks to these investigators, and that will drive higher R&D costs, as we move forward and if it's slow then we'll see it remain kind of flat?.

I guess, the variable portion of that cost is relatively small compared to the fixed portion in terms of our monthly burn. Overall, that won't likely show a major change unless for some reason we received half of the patients we need in the next month, then you might see that pop up.

But more likely it will be relatively straightforward and you won't necessarily see a major change in the reported R&D spend. And also the other thing to go along with that is we are spending some moneys on things around manufacturing and other aspects that may at one given point of time somewhat mask or smooth that out..

And then just one last one.

So if we were to estimate second half of '15, are we talking third quarter or fourth quarter?.

We are monitoring that daily, I can assure you. I will say that as we begin to get more information on enrollment, we'll have a better idea of where that stands and we'll provide updates on that..

The next question is from Ken Trbovich of MLV..

I actually have two questions.

I know that the male study is not on the critical path, but given the discussion that we've had on the female side, are you seeing the same sorts of issues on the male side with regard to enrollment?.

Yes, we do. We're seeing as a percentage, as you remember the disease is 80% women, 20% men. We are seeing the two studies run down that path currently. But yes, we see the same type of enrollment situation where you're just trying to time these patients with their flares and that's a key.

So to answer your question, yes, we're seeing the same type of enrollment..

And then just out of curiosity, I know everybody was busy with JPMorgan and the opportunities to meet with both investors and possible corporate partners.

Have you guys had much time to think about strategically whether you see this as being an environment in which there are partners available that you could perhaps use as opposed to going in alone? And where do you see that environment kind of playing out, because clearly, they're not necessarily all GI focused companies.

I am certain that there would potentially be some non-GI focused companies that would have an interest in this area as well..

Even just given the Valeant-Salix deal that has occurred, the amount of M&A and interest in the GI space is astounding to me. In the last 24 months, the number of combinations and the amount of activities going on is really pointing toward a further activity in the space. JPMorgan was very busy.

For Evoke, we had just many different meetings with companies in the GI space, companies outside the GI space. We continue to have conversations with them.

The overriding thing that I can report, is we know, that there are very, very few late-stage low-risk assets that are likely to be commercialized in the near term for pharma companies being next two, three years. So it makes Evoke and EVK-001, a very intriguing proposition for a number of firms.

Whether or not any sort of deal or otherwise has ever struck, we don't know. It's really quite frankly up to our Board, should anything ever come to pass, but it definitely means that it's one of the different things that we will closely review when the appropriate time comes.

However, I will say, we are actively looking at all the different aspects of commercialization. Dave has run commercial organizations in previous lives within pharma, for specially pharma. It is eminently viable as an asset to market in the specialty GI world.

So we will be prepared to market it on our own should that opportunity be a bigger opportunity as the Board, versus any other kind of strategic combination..

You brought up an interesting point, I guess the combination of Valeant and Salix and obviously there have been others that have occurred.

Does that make the prospects of building the commercial organization a little less daunting, because there is more talent available?.

Well, it's actually intriguing. My personal take without a lot of digging into the numbers, that there is most likely to be a number of people that have GI commercialization experience that they've begin to combine these firms and slim down in appropriate places.

It also probably means there are more assets available that some of these larger companies are going to want to release.

So they may want to be looking for other organizations to acquire and promote currently marketed products or products that are already on the market that they no longer [indiscernible] up on their own critical mass scales to market themselves.

So I'd say if anything it makes opportunities to create a commercialization organization in some ways easier perhaps just because of personnel and other opportunities available in the market..

The next question is from Yale Jen of Laidlaw..

I have two. The first one is again follow-up off the previous question regarding the R&D expenditure for 2015. The fourth quarter, the numbers seems to be lower than the previous two quarters.

Was there any reason for that, and should we use the fourth quarter number as a sort of baseline and with a modest increase for the remaining of the 2015?.

So part of that is, the thorough QT trial that we ran was predominantly in the third and fourth quarter partly. Since that has been completed, we won't have that additional R&D expense, which may have bumped up the numbers slightly toward the back half of the year.

Generally speaking, we've been running around a $1 million a month in terms of overall burn, all-in, baked in. And that's probably in the range that you should consider.

It really depends upon, if we do have some sort of major bolus of patients come through, it might be peaking higher than that, but if it maintains a relatively similar trajectory, it's probably going to be somewhere in that range..

And the second question is that is there any seasonality in terms of this, gastroparesis flayers. So you maybe predicting certain time of the year you might have a greater number of recruitment, even that the size maybe overall the same throughout the years..

There is no specific seasonality in gastroparesis. There does seem to be additional flayers perhaps in holiday seasons when people are eating a lot of different foods, there's anxiety levels and depression, if you will, we do see some tick up of flayers there, but the pin down of seasonality, no, I would say, not..

The next question is from Ben Haynor of Feltl and Company..

Just a couple of quick ones on the enrollment.

How many sites do you have up and running? And what percentages of those sites have enrolled to at least one patient?.

We have approximately 53 sites currently up and running. And I wanted to say at least two-thirds of those have enrolled at least one patient..

And then, are you seeing any sites that are starting to enroll patients more rapidly? And then is there a maximum percentage of the trial that you enroll at a single center?.

We are seeing some nice enrollment from a handful of sites. I think once they start getting enrolled themselves in terms of understand the protocol, find the patients, how to find them, you generally see them really have a nice boost in enrollment.

In terms of a percentage in these diabetic gastroparesis study, since we have 200 patients and we have a number of sites, we are not too concerned about having too many patients at one site. In the Phase 2 trial, we did run into that issue, and we don't expect that in Phase 3..

The next question is from Irina Koffler of Cantor Fitzgerald..

I just want to push you a little bit on this M&A discussion question a little bit more.

How are you thinking about potentially selling the company ahead of your data? Is that something that you would consider or are you going to wait until after you get your topline results? And are your partners potentially interested in acquiring you before or is everyone just want to wait for the data?.

You raise a great question. And it's always what price can you get, when, and as Matt described, what the Board would assume the right price to be. Personally I think we have to look at all options and then make the decision for the company for the shareholders at the right price.

Matt, do you have some comment?.

I'll just comment, it's surprising to me that, I think in years past that wasn't even a conversation to put on the table, but I've been surprised that people have asked that question. So it's something we have to examine and again it will come down to what the value was perceived by all the different parties involved, especially our Board..

Just given that your stock is or the market cap is so small now, I mean someone could pay double, triple of what it's trading at now, but it's still under values the asset?.

We absolutely agree with you. Again, it goes back to what the Board would perceive as the correct value at the time. None of us believe that where we are today is the correct value. So really it depends on how to get there at that point in time. We'll have to wait and see.

I mean who knows where our stock price will be in two days or two months or at the end of the year for that matter. We'll have to evaluate that later on. But we all agree with what you describe..

We have no further questions at this time. I would like to turn the floor back over to Mr. Gonyer for any additional remarks. End of Q&A.

Well, I'd just say thank you everybody for joining and thanks for the great questions. We'll continue to provide our updates. Thank you..

Thank you. Ladies and gentlemen this does conclude today's teleconference. You may disconnect your lines at this time. And thank you for your participation..