Evofem Biosciences, Inc.
Q2 2018 Earnings Call Transcript

Published:

  • Operator:
    Good morning ladies and gentleman and welcome to the Evofem Biosciences Q2 Earnings Conference Call. At this time all participants are on a listen only mode. Later we will conduct a question and answer session and instructions will follow at that time. [Operator Instructions] As a reminder this conference call is being recorded. I will now like to turn the call over to your host Ms. Amy Raskopf. Please begin.
  • Amy Raskopf:
    Thank you, good morning everyone and welcome to the first ever Evofem Biosciences financial results call. This is Amy Raskopf, Investor Relations for Evofem and with me today are Saundra Pelletier, Evofem’s Chief Executive Officer and Jay File, our Chief Financial Officer. After discussion of the business and review of the second quarter and first half financial results Saundra and Jay will be joined by our Chief Commercial Officer, Russ Barrans and Dr. Kelly Culwell our Chief Medical Officer for our Q&A session. If you have not already received it please access the financial results press release we issued earlier this morning at evofem.com under the investors tab. A webcast of today's call is also available on the same section of our website. During the course of this call management will make projections and other forward-looking remarks regarding future events and Evofem future performance that constitute forward-looking statements with the purposes of the Safe Harbor provision under the Private Securities Litigation Reform Act of 1995. The words believes, anticipates, plans, potential, position, expect, will and other words noting future events identifies statements as forward looking statements. These forward-looking statements reflect our prospect on current trends and information and they are not based on historical information. Such Forward-looking statements are not guarantees of future performance and involve risks and uncertainties, including those noted in today’s press release as well as Evofem's filings with the SEC, including our 10-Q for the quarter ended March 31, 2018 which was filed on May 14. Actual results may differ materially from those projected in the forward-looking statements. Evofem specifically disclaims any intangible obligation to update these forward looking statements accept as required by law. In addition we will refer to certain information from government publications and general publications and research surveys and studies conducted by third party. This information has been obtained from sources believed to be reliable although they do not guarantee the accuracy or completeness of such information. We have not independently verified market or industry data from any third party sources. Information for the replay and the archive webcast of this call is noted in today’s press release. For the benefit of those who may be listening to the replay or archived webcast this call was held and recorded on August 2, 2018. Please reference our most recent press releases and SEC filings for any subsequent announcements related to the topics discussed. With that I will turn the call over to Saundra Pelletier, CEO of Evofem.
  • Saundra Pelletier:
    Thank you so much Amy. First I want to thank everyone for joining our first financial results call and our quarterly update. It has been a very exciting year for us and we’re thrilled to welcome a great group of new institutional shareholders as well as our research analysts who recently begin covering our Evofem story. So today I’m going to share a lot of information in a short amount of time. I am going to update you on our contraceptive study I'm to going to share with you an idea of who our team consists of Evofem. I’m going to describe for you who is the Amphora women, I’m going to tell you about our satisfaction survey that we’re conducting. I’m going to update you on our SPI study and finally I’m going to briefly talk about our additional asset for BV. And in the end you will be all be closer to being expects on vaginal health and the world will be a better place. So let’s get started. So with Evofem our core mission is to develop and commercialize products that address the unmet need of women sexual and reproductive health. Our lead product candidate is Amphora. It’s a hormone free on demand women controlled bio adhesive vaginal gel, and it maintains a women’s vaginal pH and what is considered normal and a healthy range which is 3.5 to 4.5, even with the introduction of semen. So this range creates an environment that’s inhospitable to sperm and it’s also inhospitable to many viral and bacterial pathogens associated with sexually transmitted infections like Chlamydia. Amphora comes in a prefilled applicator it’s very discreet many-many women are used to using applicators, it’s a little bit like a tampon and the gel is very viscous it’s translucent and it’s inserted into the vagina within an hour of having sex, Amphora adheres to the surface of the vagina and the cervix and it provides a lubrication while maintaining a women’s vaginal pH both before and after ejaculation. Amphora must be reapplied for any subsequent after sex because it is an on-demand method. So we’ve made significant strides in the development of Amphora in the past year; we’ve initiated and fully enrolled a confirmatory Phase 3 clinical trial for Amphora for contraception; our team’s patient recruitment campaign was so effective that we had 500 extra women still wanting to enter the clinical trial when we reached our enrollment target this past February. So in total we enrolled 1,400 women aged 18 to 35 at a 112 sites in the United States; the study is advancing ahead of schedule and we’re looking forward to reporting top line results at the end of this year; with those positive study results we expect to refile our NDA for Amphora as a contraception -- as a contraceptive sorry in the first half of 2019; so under the Prescription Drug User Fee Act the FDA review times of this is six months, so we expect to have the FDA’s decision in the fourth quarter of next year. So approval will enable us to launch Amphora in the U.S. early in the first quarter of 2020 and it again will be the first and the only non-hormonal prescription women controlled on-demand contraceptive drug. So, I said to you in the beginning I was going to tell you little bit about the team of people because I think it’s very-very important it’s not just about having an amazing innovation, but it’s also about who are the team that are going to execute with this innovation. So we’ve assembled an incredible team and really have unparalled expertise in women’s health; our Chief Commercial Officer, Russ Barrans has held senior level positions at global and domestic companies, TEVA, Bayer, [YS], he was responsible for launching successful innovations like Mirena and Plan B; our Chief Medical Officer, Dr. Kelly Culwell is an OBGYN and it’s really important because it keeps us really relevant and grounded to what are providers thinking; she has over 15 years of specialization in women’s health in contraceptive research; she’s overseen large contraceptive clinical trials globally; she was a Senior Medical Advisor for the International Planned Parenthood Federation and she served as a Medical Officer for the World Health Organization; and Brandi Howard who oversees our contraceptive and STI prevention trials is our Vice President of Global Clinical Development and Medical Affairs, she too has over 15 years in the pharmaceutical industry; she has held leadership positions at TEVA, Organon and Duramed, her roles that included the Head of the U.S. Medical Affairs overseeing a 120 medical science liaisons as well as U.S. Medical Director and Women’s Health of TEVA. So, these are just three people, and every single person, I wouldn’t take the whole call to do it but I could. We’ve a very talented team of people and the overarching theme that I really want you to hear is that at every level in this organization we have deep relevant experience, yes of course we’ve a passion for women’s health; but this team understands how to successfully commercialize our asset Amphora. So who is this Amphora women, our market research indicates that the non-hormonal and women controlled aspect of Amphora is what makes it an attractive option. So I want to frame it for you, so right now there’re 43 million women who are at risk at becoming pregnant in the U.S.; 17 million of those women are currently using hormonal contraception, so those are the women who make up the $5.5 billion contraception category. But meanwhile okay, this, this is the really where the rubber meets the road here on this call I think. There are 16.5 million women who are doing nothing to protect themselves against pregnancy. The majority of them have tried and stopped using hormonal contraception. And doing nothing places them at 85% relative risk of getting pregnant within one year. So clearly here is what these women have said to us. They have said, that they are less concerned about the possible increased risk of pregnancy compared to the perceived risk of prolonged hormone exposure and hormonal side effects. Also there is an additional 8.5 million women who are using nonprescription contraception methods like the rhythm method, withdraw and condom. So this represented total of 25 million women who could potentially benefit from Amphora. So here is what we think, we believe the early adaptors of Amphora will fall into two categories. The first is going to be women who are seeking an alternative to hormonal contraception. These women who are currently doing nothing and really left wanting. Hormones cause women to experience undesirable side effects. It reported the women will switch their contraception options three to four times throughout their lifetime because of side effects due to hormones. These side effects are real, they're weight gain, headaches, acne, bloating, breast tenderness and loss of sexual desire. Women are concerned about the lasting impact of prolonged hormone exposure on their future fertility. And a lot of women will tell you they don’t have hormones in their milk, they don’t have it in their meat and they don’t want it in their contraception. So Amphora is going to greatly appeal to these women. So the second group of women. These are women who we believe will use Amphora as an added protection to their current form of birth control together with the lubricating properties of Amphora. 28% of women we surveyed indicated that Amphora would be an important addition to their current method of contraception. And so let's be honest, condoms breaks and women do forget to take their pills and partners fail to withdraw. So Amphora is a reliable back up with the added benefit of lubrication provided with its highly viscous bio adhesive gel. So if we are approved we will look forward to offering women the first non hormonal on demand women controlled prescription contraceptive product. They only use it when they need it. So I want to talk to you a little bit about the survey I mentioned in the beginning. So our confidence is actually bolstered because in our early findings we commissioned this User Experience Satisfaction Survey. So I know that’s a long title but here is basically what it is. The survey is being conducted with women who have completed the study. Now we call the study Empower so if you hear us talk about Empower that is the contraceptive study. So we looked at women who have already completed the trial we talked to their male partners and we talked to study investigators. The initial responses through the research indicates that more than 80% of women and their male partners are satisfied or highly satisfied with Amphora and more than 80% of women who completed the study said they would recommend Amphora to a friend. So we are looking forward to sharing the fruitality of this findings once the Empower study concludes and these completers have an opportunity to respond to the survey. So based on everything we have seen to date we are very optimistic about the potential of Amphora amongst identified women who need and desire a non hormonal method. So I’m going to shift a little bit now toward FTI. So alongside the contraceptive trial we are also working to maximize the potential of Amphora by developing and expanding our label and lifecycle managing this -- this asset. So we are going to build on our positive findings of prior studies and we are evaluating Amphora in a Phase 2b clinical trial to prevent two common sexually transmitted infections. So it’s a double blinded placebo controlled trial with 844 women ages 18 to 45 at 50 centers. Primary endpoints is to show a statistically significant difference in the rate of infection with Chlamydia for women treated in the Amphora arm versus placebo. In February the FDA granted us fast track designation for Amphora for prevention of Chlamydia. So what this says to us is that the FDA believes that there is a significant need for a preventative therapy like Amphora. And in 2016, there were 1.6 million new cases of Chlamydia in the U.S. alone and the CDC estimates they are actually more than 2.9 million infections every year. So we're really excited to lead in the development of the first multipurpose prevention technology for the prevention of pregnancy and the prevention of sexually transmitted infection and we look forward to advancing Amphora for these and additional indications in the future. And we really believe the successful expansion of Amphora's label to include both contraception and prevention of Chlamydia is really going to maximize the potential appeal in commercial viability of the asset. And then finally, our pipeline also includes a second vaginal gel product candidate. It’s going to be intended for the prevention of recurrent bacterial diagnosis commonly referred to as BD. So we did do a Phase 1 study and it was a dose finding study and our BD product candidate reduced vaginal PH for up to seven days following a single administration. So we want to continue to explore this opportunities but most importantly we're going to strategically focus our resources on the approval of Amphora as a contraceptive product first. This is an additional asset though as we get more capital that we can invest in, it will be a separate NDA in the category that is also very underserved. So in closing, we are focusing on investments where we believe we can most rapidly build value for our company and for our shareholders and for the patients that we aim to serve. So with that I'm going to turn the call over to our CFO Jay File.
  • Jay File:
    Thank you Saundra, and good morning everyone. Since Evofem is in development stage company with no revenue to report I'm going to move right into a discussion of our operating expenses. For the three months ended June 30, 2018, research and development cost were 11.8 million versus 4.1 million in the prior year quarter. The increase was driven by a 5.3 million increase in clinical trial cost when compared to the same period in 2017. Specifically this increase was associated with our ongoing confirmatory Phase 3 clinical trial for Amphora as contraception and to a lesser extent, our Phase 2b clinical trial of Amphora for prevention of Chlamydia and gonorrhea in women. Both of these trials initiated enrollment in the second half of 2017. We expect R&D expenses to remain higher compared to the prior year as we complete the Phase 3 contraception trial this fall and advance enrollment in the Phase 2b clinical trial. Also contributing to the increase was a 2.3 million increase in non-cash stock based compensation associated with options that were granted in the second quarter of 2018. General and administrative costs were 11.4 million in the second quarter of 2018 versus 2.3 million in the prior year quarter. The increase was due to an 8.7 million increase in personnel costs, which included an 8.1 million increase in non-cash stock-based compensation associated with option grants during the second quarter of 2018. As a result, our loss from operations was 23.2 million in the second quarter of 2018 compared to a loss from operations of 6.4 million in the prior year. Net loss attributable to common stockholders was 22.2 million or a loss of $1.11 per share for the three months ended June 30, 2018 compared to a net loss of 7.4 million or loss of $3.78 per share for the prior quarter. Moving to the first half results research and development costs were 23.8 million for the six months ended June 30th, compared to 6.1 million for the prior year period. The increase was driven primarily by 14.4 million increase in clinical trial costs related to our ongoing clinical trials. As I mentioned previously both of these were initiated in the second half of 2017. A 2.3 million increase in non-cash stock-based compensation associated with aforementioned option grant during the second quarter also contributed to the increase. General and administrative costs were 20.4 million for the six months ended June 30, 2018 compared to 5.2 million for the prior year. The increase was predominantly due to a one-time merger related costs incurred in the first quarter 2018, as well as the aforementioned option grant. As a result loss from operations increased to 44.2 million in the first half of 2018 compared to a loss from operations of 11.3 million for the prior year period. In summary, the 32.9 million increase in operating expenses and loss from operations in the first half of 2018 versus the prior year period predominantly reflect 14.4 million increase in clinical trial costs, 10.4 million in aggregate of non-cash stock-based compensation, 4.9 million one-time merger related costs and approximately 1 million related to increased rental. Total other expense for the first half of 2018 was 48.1 million compared to 500,000 in the prior year. The increase was due to a non-cash loss on the issuance of warrants issued in the first quarter of 2018 that was associated with a reverse merger. There was no comparable expense in the 2017 period. The net loss attributable to common stockholders was 92.4 million or a loss of $5.15 per share for the six months ended June 30, 2018 compared to a net loss of 13.6 million or loss of $6.92 per share for the prior year period. To wrap up in May, we raised 37.5 million in net proceeds from the underwritten public offering of common stock and warrants to existing and new institutional investors, net of underwriting discounts and commissions, but excluding operating cost. We close the quarter with $22.8 million in unrestricted cash versus 5 million as of March 31, 2018 and with that I will return the call back to Saundra .
  • Saundra Pelletier:
    Great thanks Jay, so it is been an incredibly exciting year for Evofem and we’re thrilled about the progress we've made to date. We have several upcoming catalysts and most notably, most importantly is our top line Phase Three data which we now expect will be at the end of this year. So we’re at the forefront of a revolution in women’s health. We’re excited to be developing the very first non hormonal on demand women controlled prestriction contraceptive drug and we look forward to providing additional updates on our pipeline progress our pre commercialization activity is going forward. So with that operator would you please open up the call for questions. Operator?
  • Operator:
    [Operator Instructions] Your first question is coming from the line of Randall Stanicky of RBC Capital Markets. Please go ahead.
  • Randall Stanicky:
    So I just got a couple questions. First can you talk a little bit about how you're viewing the importance of the STI claim over prevention of pregnancy how are you thinking about the market, individually and then from a combined perspective tapping into a new part of the base, perhaps, and then secondly, with the pull forward in the study timing, which is encouraging. Can you talk about when do you, when you start to think about commercial and adding in some critical infrastructure for launch. Thanks.
  • Saundra Pelletier:
    Perfect thanks very much Randall. So just to allow some of the other team members to contribute, Russ would you mind taking Randall’s question please both about how we plan to add on the STI and grow the market and then the commercialization adds?
  • Russ Barrans:
    Sure, so when looked at market research, and we queried women we talked to about 1,400 women in total so far. We put the target profile before them, and then after they had looked at the contraception we added in that question of how interested they would be relative to a product that could prevent Chlamydia and gonorrhea and the interest in that among women increased by about 25%. So what we found not only among women but also among healthcare providers was that there was added interest in a product like this that had more than one benefit in contraception, but add to that benefit of also protecting them against an STI. So when we looked at that because there were no other products that are currently approved for the prevention of Chlamydia as a prescription that together with the use of a condom which always be encouraged to practice safe sex many women thought it was going to be of great benefit to them as well did -- as well did the healthcare providers. When we look at the commercial side of this, we will actually begin the ramp-up of that starting with the hiring of our marketing team which will start in the fourth quarter of this year and then will begin in earnest in the beginning of next year as we put all of our marketing tools together and then the sales team will be hired at the end of third quarter for managers, next year with the sales consultant being put on at the -- in the fourth quarter with the preparation for launch in the beginning of 2020.
  • Randall Stanicky:
    That's helpful. Let me just add one more follow-up you’ve talked about sexual satisfaction potential claim in the past how I guess Saundra or Russ how does that factor into your marketing message and when would you expect to be able to make that claim I assume that’s part of the ongoing trial, sectarian play?
  • Saundra Pelletier:
    So Russ do you want to start from the marketing standpoint and then maybe Kelly and I can jump in with the clinical side and appeal to women and providers?
  • Russ Barrans:
    Yes, absolutely so of course most of us would know that OPDP which is the branch of the FDA that approves marketing messages would not allow us to state this as a fact unless it was in the label and we don't anticipate that it would be in the label given that it is an exploratory endpoint, one of the things that we will do post approval is run some Phase 4 studies that we can duplicate that same result of which -- at which time once we’ve got multiple studies or surveys that have indicated that there is a possibility that we’ll be able to include that into our marketing at that point, of course, we will be able to share those data at key clinical meetings that are presented throughout the year to make others aware of the fact that this data was done. And I want to mention as we talked about the user satisfaction survey, which is not quite the same as the sexual satisfaction and that we were looking at this just relative with product but they will kind of go hand-in-hand relative to our ability to promote on that once we gather all that information and then confirm it again with another follow-up Phase 4 study.
  • Saundra Pelletier:
    And also Randall I think it would good too Kelly if you could just share a little bit from the clinical side why do you think it’s important, for both the providers and women, just…
  • Dr. Kelly Culwell:
    Sure, absolutely. So, just to back up a little bit on that sexual satisfaction markers that we are using in this trial and the exploratory endpoint have been developed in extensive consultation with keeping new leaders who are at the forefront of this research. So we are utilizing the tools that they utilize in their research as part of our clinical trial. And we have also included as an exploratory endpoint in our STI trial as well. So as Russ mentioned we will be able to use this information even before we get end to the label and even if we don't we will be able to use it as part of our publication and scientific presentation strategy to encourage doctors and other healthcare providers to consider this as an aspect of the overall patient centric contraceptive counseling that we will continue to encourage them to provide recognizing that women who might have issues with sexual satisfaction with their hormonal contraception as an example could benefit from learning that this product is not only does not negatively impact their sexual satisfaction but actually might have a positive impact on it. So it'll be part of the overall kind of counseling message that we encourage healthcare providers to have through our medical science liaisons and our medical affairs strategy.
  • Operator:
    Your next question comes from the line of Yasmeen Rahimi from Roth Capital Partners. Your line is open. Please go ahead.
  • Yasmeen Rahimi:
    Hi team, congrats again, on continued solid execution. My first question is team, can you remind us again as where we are headed into AMP002 data that's going to be reported at yearend? What are we expecting especially given the incorporation of changes in the study of tighter inclusion category of younger population, the tightening of the inclusion cycle so you could give us a little bit of what is your perfect case scenario of data expectations?
  • Saundra Pelletier:
    Okay, perfect, hi Yasmeen, so I’m going to actually ask Kelly to talk about that and maybe too the inclusion just about the cycle of you know why it’s a little bit different with non hormonal as well.
  • Dr. Kelly Culwell:
    Right, so our inclusion criteria for this trial remains sort of the standard for what the FDA considers for contraceptive trials the primary efficacy population of women 18 to 35. So that is a population that the FDA looks at for efficacy. Usually anything that’s included for women over the age of 35 is really only for safety purposes and it was not necessary in this trial to include any women above the age of 35 because we are really looking for confirmatory efficacy numbers. The way that the trial is designed is a bit different than the traditional hormonal contraceptive trials as we discussed which is around allowing women to start the product at any point of their cycle is one example. So women who enroll in the trial can immediately start using Amphora and we want to be able to collect data immediately after they enroll in the trial. And that first cycle before they have their first menstrual period on studies is considered Cycle Zero. So we actually have agreement with the FDA that we can include Cycle Zero as a part of our analysis as long as the women would have risk for pregnancy during that period. So it has to be of a certain length so that we know that she ovulated and could have become pregnant in that initial cycle. So we have agreement on that. We are also -- we had to clarify what cycle during the trial would be considered an ovulatory cycle or again, a women at risk of pregnancy. So the cycles between 21 and 35 days are considered ovulatory for the purposes of this trial and those will be the cycles that are included for our primary efficacy analysis. We will also be doing a sensitivity analysis that include cycles that are slightly longer than that up to 42 days which also are traditionally considered to be ovulatory cycles. So we'll have -- we'll be able to look at the data both ways from more restricted cycle length and a slightly greater cycle length.
  • Yasmeen Rahimi:
    I think it just as you are reporting typical views on 001 study you saw a typical use of around 89.5% so given this incorporation my thought process is would we be anticipating a higher typical use response or should we be coming in at that same rate, which is still was a very important number.
  • Dr. Kelly Culwell:
    I think the two key components here are what is it -- what do we need to see to get approval and then what is the women's risk of pregnancy when she is not using any contraception which is our primary target population. So for a woman who is not using any contraceptive method she has an 85% risk of getting pregnant in the first year of that, so we are definitely going to be better than that with our question and then we have established with the FDA that the threshold we need to meet for approval is that the typical use failure rate at the end of seven cycles will be less than 16.5% with an upper limit of the 95% confidence interval being 21%. So that is threshold that need to meet we feel very confident we can meet that threshold based on as you mentioned the results from Amp 001.
  • Yasmeen Rahimi:
    Thank you Kelly, and then if I may ask one follow-up question in regards to the market research that you recently that you announced earlier today. Can you was there any differences seen in user satisfaction between younger women versus older, I'm aware that you're holding it for the presentation but just in case if you can share any little bit of color would be very helpful for us?
  • Saundra Pelletier:
    Okay, perfect, Russ do you want to take that?
  • Russ Barrans:
    Sure, so far we don’t have enough of the women who have completed the study that have entered into the satisfaction survey to delineate that to a point where I would feel comfortable to say that there is a difference, but as was mentioned before, with over 80% saying that they were satisfied or very satisfied it's not likely that were going to see much delineation across the board because overall it seem like it didn’t matter which age group they were in that they were satisfied or very satisfied with being a part of the study and using the product. So don’t have that specifically for you at this point but would anticipate that there will not be a big difference because the overall rate is quite high.
  • Operator:
    And your next question comes from the line of Ram Selvaraju from H.C. Wainwright, your line is open, please go ahead.
  • Ram Selvaraju:
    So firstly I was just wondering, if you could comment on the likelihood or non-likelihood of any supplemental potential real world or the usage studies to be applied with Amphora to simply gauge patient compliance or ease of the use of the product prior to regulatory approval or if you think that specific aspect of product development will have been comprehensively addressed in the existing clinical development plan. Secondly, if you could perhaps comment on any potential future development work that you might undertake to address a new sexually-transmitted disease called Mycoplasma genitalium wondered if you were familiar with this, if you have any thoughts on potentially doing some development work in that specific area and then lastly a housekeeping question regarding the stock-based compensation, noticed that there were large number of option awards in the second quarter and just wanted to get a sense of at what rates option awards would occur on a quarterly basis going forward and to what extent we could consider this nonrecurring. Thank you.
  • Saundra Pelletier:
    Great, perfect thanks Ram. Okay so Kelly you want to start and then they can talk about the.
  • Dr. Kelly Culwell:
    Sure yes, so the answer to your first question about any additional work we anticipate on real world usage or compliance, we don’t anticipate doing any additional work on that before approval, we between our Phase 3 contraceptive trail which has a lot of information about compliance through our e-diary as well as the user satisfaction survey from women who have completed the trial, we still will have extensive information about usability, easy of use compliance and satisfaction. And so we don’t anticipate we need to do anything else prior to approval on that point. With regard to Mycoplasma yes we have been following this closely and it’s definitely a very interesting area, we’re in the process of looking at our in vitro data which is not looked at this bacteria in the past but this is something that we -- it follows very closely with the epidemiology and risk factors for Chlamydia and so it's definitely something that we are exploring and taking a look at for a development pathway.
  • Saundra Pelletier:
    Okay and anyone want to talk about stock based compensation.
  • Jay File:
    Yeah, absolutely, just to frame it a little bit it was highly unusual to see such a large non-cash stock-based compensation charge come through. As a reminder, due to the reverse merger that happened in the first part of the year, there was a significant impact to the equity holdings of the company that were of the employees of the company that were basically either taken back and surrendered or made extremely diluted significantly because of the reverse merger and the exchange ratio as such there was an attempt by the compensation committee to achieve parity with what the prior equity holdings were with the company and therefore you saw a lot of the grants that came through in the first half of the year, that had somewhat accelerated vesting or investing at time of grant because it was making a parity with what it was in private Evofem. So to move that going forward you will not see that type of grant going forward because it was a one-time effort to get everyone back on the same level and ensure that the overall incentive compensation plan was still attractive and maybe consistent with other companies in the industry.
  • Saundra Pelletier:
    Ram does that answer your question on both sides.
  • Ram Selvaraju:
    Yes, absolutely. So just for clarification purposes, what would you say would be the approximate quarterly cash burn going forward from this point?
  • Jay File:
    Sure. So as you know obviously with running a couple clinical trials we expected burn to be relatively higher during the first part of the year as we complete AMP002 and then now will continue to lower in subsequent quarters as we wind down that clinical trial and then the Phase 2B continues with enrollment into 2019. Overall, I think we anticipate that as we move through the second half of the year we’re going to gravitate down more towards a cash burn rate in the 4 million to 6 million by the end of the year.
  • Saundra Pelletier:
    A quarter.
  • Ram Selvaraju:
    Great, thank you, very much.
  • Operator:
    Our last question comes from the line of Leland Gershell of Oppenheimer. Please go ahead, your line is open.
  • Leland Gershell:
    Just one question for me, when might we expect to see the results put out from the survey data that you had collected in terms of medical meetings coming up?
  • Saundra Pelletier:
    Right, so we anticipate that we’ll have results to be able to present at medical meetings starting next year; those meetings would include ACOG, the North American Forum on Family Planning and potentially ASRM, The American Society for Reproductive Medicine, those would be the three key conferences we’d be targeting for presentation of that information. Because we do intend to continue to collect the data until we have last patient out and we want to make sure that we’re getting as many in the totality of these women and their partners and the providers. So, yes next year we’ll be able to share.
  • Saundra Pelletier:
    Any other questions? Okay. Okay, perfect, well than in closing I just want to thank you all, very-very much for joining us this morning and I just want to say just that's obvious but is the most effective method of contraception; is a method that woman can use and what we say to everyone is that if a women can and will use the hormone she should but if you’re a women that’s in that 25 million that it’s currently in the 16.5 million that’s currently doing nothing with an 85% risk of getting pregnant in the first year we really believe that we are going to bring to the market an innovation and a solution for you and so we really look forward to hearing more about Evofem and all of our progress and we look forward to seeing many of you at the Solebury Trout CEO Round Table later this month and at the H.C. Wainwright Conference in early September in New York. So, thank you again very much. We appreciate your support and your interest and have a great rest of your day.
  • Operator:
    And ladies and gentlemen this does conclude today’s conference call. Thanks for your participation and have a wonderful day. You may now disconnect.