Sam Martin – VP, IR, The Ruth Group Dave Gonyer – CEO Matt D'Onofrio – Chief Business Officer.
Yale Jen – Laidlaw & Company.
Welcome to the Evoke Pharma Third Quarter 2014 Financial Results Earnings Conference Call. (Operator Instructions). It is now my pleasure to introduce Sam Martin, Vice President, Investor Relations at The Ruth Group. Thank you. You may begin..
Good afternoon and welcome to Evoke Pharma's third 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 of Evoke Pharma.
Earlier today, Evoke issued a press release announcing the financial results for the three months ended September 30, 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 quarterly 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 and quarterly report on Form 10-Q. This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, November 13, 2014.
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, Sam. Thank you all for joining us this afternoon to discuss Evoke's financial results for the third quarter of 2014 and provide an update with regard to our ongoing clinical development of our lead product candidate EVK-001 for the treatment of symptoms related to gastroparesis in women with diabetes.
We continue to be excited about our business prospects and believe this is an incredible time for the company and its supporters and there are several reasons for a positive outlook.
Notably we continue to progress as planned with our pivotal Phase 3 trial for EVK-001 in women and are ahead of our goal with a thorough ECG study, or better known as the thorough QT study. We expect top line data from the ECG study by the end of the year as we had previously stated that we have data in early '15.
Based on feedback from the FDA at our end of Phase 2 meetings, these are the only two additional studies required to file an NDA application for EVK-001. Therefore once we receive data of our ECG study we only need to receive data from our Phase 3 trial in women to finalize the clinical development for the NDA submission.
I'm very proud of our team which has done an excellent job executing our clinical development strategy.
As we reiterated in our past calls Evoke was founded to develop and enhance delivery method for metoclopramide which would provide a clinical benefit over the currently available oral product that’s on the market today to treat the symptoms associated with diabetic gastroparesis while the mechanism of action in itself is effective in treating these symptoms the oral delivery route is not always appropriate.
With the lack of motility and sometimes severe nausea and vomiting suffered by these patients among other symptoms an oral treatment may have problems getting into the patients systems efficiently.
When is administered orally not only can it be difficult to expand – expect to meaningful blood level of the drug but it is not absorbed in a predictable manner but keeping it into the body can be a challenge as well because of the nausea and vomiting related to the disease.
Our market research indicates that physicians understand that having an intranasal delivery of metoclopramide makes sense as it enables the drug to enter the blood stream directly by passing the digestive system.
Therefore predictably allowing absorption in the question of whether the drug remains in the body are for the most part taken out of the question. Not only is there a need for a new product, but there is a need for a substantial – there is also a substantial market for EVK-001 that we can capture.
On an annual basis there are approximately 4 million prescriptions written for oral medical per year. Given the lack of predictability of absorption that can be seen with oral formulations we believe there will be an opportunity for EVK-001 to gain a significant share of the sizeable market.
Before I hand it over to Matt D'Onofrio, I just like to emphasize how pleased we’re about our current position and a potential market opportunity for EVK-001.
Diabetic gastroparesis has a tremendous negative impact on these individuals that suffer from it and we believe that we have the ability to offer an effective treatment that these patients desperately need.
We have dedicated the past several years to progressing through clinical trials and with the development milestones we anticipate in the coming months and year this is a great time for Evoke.
Matt?.
Thanks, Dave. And once again thanks for you all joining. In the third quarter of 2014 we reported a net loss of 3.8 million or about $0.63 per share based on weighted average shares outstanding of approximately 6.1 million.
This compares with a net loss of 486,000 or $0.41 per share based on approximately 1.2 million weighted average shares outstanding for the third quarter of 2013. The increase is due to our ongoing Phase 3 trial and thorough ECG study. R&D expenses in the third quarter of 2014 were 3.1 million up from 79,000 in the third quarter of 2013.
The year-over-year increase in research and development expenses was primarily related to an increase in clinical trial cost associated with the Phase 3 trial as well as the thorough QT study for EVK-001.
General and administrative expenses in the third quarter of 2014 were approximately $733,000 compared with approximately $407,000 for the third quarter of 2013. The increase is attributable to an increase in headcount and cost associated with public reporting requirements following the company's initial public offering.
Total operating expenses in the third quarter of 2014 were 3.8 million up from 486,000 in the third quarter of 2013. For the nine months ended September 30, 2014 we reported a net loss of 10.3 million or a $1.71 per share based on weighted average shares outstanding of approximately 6 million.
This compares with a net loss of 1.2 million or a $1.06 per share based on approximately 1.2 million weighted average shares outstanding for the prior year period. R&D expenses in the nine month period ended September 30, 2014 were 7.8 million up from approximately 321,000 for the nine month period ended September 30, 2013.
General and administrative expenses in the nine month period ended September 30, 2014 were approximately 2.4 million compared to approximately 700,000 for the nine months ended September 30, 2013.
Total operating expenses for the nine months of 2014 were 10.2 million versus 1 million for the same period in 2013 and looking at our balance sheet as of September 30, 2014 we had cash and cash equivalents of 12.2 million.
Finally, we recently became S-3 Eligible and in preparation for potential commercialization and as a prudent corporate finance, today we filed a shelf registration on Form S-3 and entered into an aftermarket issuance sales with MLV.
Once declared effective, S-3 will us flexibility to consider various financing strategies for the commercialization of EVK-001. We want to note that we do not expect to raise additional capital until after we receive top line data from the Phase 3.
As you can see from our current cash position access to debt and a quarterly rate we’re well positioned to execute the ongoing trials as planned. That concludes our prepared remarks. We would like to open up the call to questions.
Operator?.
(Operator Instructions). Our first question comes from (indiscernible) with Cantor Fitzgerald..
Just wanted to see if we should look at R&D expenses a pretty good run-rate for future quarters because you’re pretty much in the final leg of the Phase 3 study as well I think..
It probably will go up slightly as we’re running through patients and closing things out hopefully in the appropriate duration. It won't be radically different so there might be slight uptick, it kind of depends upon the flow through..
And then could you characterize at all the percent enrollment that you’ve had at this point and also maybe in general have you seen any SAEs [ph] in the study that you want to comment on..
No SAEs of significance that we will comment on at this point. So things are running as we plan there and also in terms of enrollment it's progressing as we have planned as well. So overall we’re pushing forward and also happy to note that ECG study that we will have data before the end of the year..
And then just one last one, given the late stage at the game at this point, how would you characterize the M&A environment in general in the GI space right now? Thanks..
Sure. Well obviously there has been tremendous M&A in this space over the last year or two, activist has collected 4 or 5 different GI companies underneath its wings very recently. We continue to talk with group's we have known many of the GI players and some others that aren't specifically GI.
You will wait and see what that comes at a later date, we have nothing else to describe other than in general there are very, very few late stage assets and that we’re having fewer in the GI space..
(Operator Instructions). And our next question comes from Yale Jen with Laidlaw & Company. Please proceed..
So you’ve – last time you mentioned 50 out of the 60 sites already activated in recruiting and at this stage you will continue to exercise upto 60 or you think you’re in the right size, right number of clinical site moving forward?.
I think we’re in the right number of sites but we’re always evaluating sites as they are performing or not performing and we may look at it adding other sites if necessary but we’re at a pretty good spot right now..
So is the 50 still in the right ball park or you think there is an increase in there?.
Yes, it's in the right ball park..
Okay and therefore up here is that you are conducting the males patient study. I know it's not part of the NDA package, filing package but any comment you’ve at this point in terms of finding any information or any comment on there..
It's running again much like the female trial as we expected. As you know 80% of the patients that have this disease are females, the other 20% are males. So it's always going to enroll a bit slower than a female trial but that’s what we expected. So there is no surprises..
And you will still stop the enrolling when you finish the female patient enrollments, is that right?.
Exactly..
(Operator Instructions). There are no further questions at this time. I would like to turn the floor back over to David Gonyer..
Great. Thank you everyone for the call today. We appreciate the support and we continue to update everyone on these quarterly calls. Take care..
Thank you. Ladies and gentlemen this concludes today's conference. You may disconnect your lines at this time. Thank you all for your participation..