Obseva SA (OBSV) 2018 Q2 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the ObsEva Second Quarter 2018 Financial Results and Business Update Call. (Operator Instructions) As a reminder, this conference call is being recorded.

I would now like to turn the conference call over to Mr. Mario Corso, Senior Director, Investor Relations. Sir, you may begin.

Thank you, operator. Good morning, everyone, and welcome to today's call to review ObsEva's Second Quarter 2018 Financial Results and Business Update.

On this call, I'm joined by Ernest Loumaye, our Co-Founder and Chief Executive Officer; Jean-Pierre Gotteland, our Chief Scientific Officer; and Tim Adams, our Chief Financial Officer.

During the call today, we will make forward-looking statements, and we remind you of our safe harbor language. We will make forward-looking statements, including but not limited to statements relating to financial results and trends; the process and timing of anticipated future development of ObsEva's product candidates; our gonadotropin-releasing hormone or GnRH receptor antagonist, linzagolix, formerly OBE2109; our oxytocin receptor antagonist, nolasiban; and our PGF2 alpha-receptor antagonist, OBE022; including clinical trial results and potential regulatory pathways toward gaining approval of our product candidates in the U.S., Europe and Asian countries as well as the therapeutic and commercial potential of ObsEva's product candidates.

These forward-looking statements are based on ObsEva's current expectations and inherently involve significant risks and uncertainties. ObsEva's actual results and timing of events could differ materially from those anticipated in such forward-looking statements and as a result of these risks and uncertainties, which include, without limitation, risks related to ObsEva's development programs; clinical trial time lines and results; the uncertain clinical development process, including adverse events; the success cost and timing of all development activities and clinical trials; the market potential for ObsEva's product candidates; the accuracy of ObsEva's estimates regarding expenses, capital requirements and the need for financing; and other risks detailed in the risk factors and elsewhere in ObsEva's U.S. Securities and Exchange Commission filings and reports, including its 20-F report filed on March 9, 2018. ObsEva undertakes no duty or obligation to update any forward-looking statements contained in this presentation as a result of new information, future events or changes in its expectations.

I will now turn the call over to Ernest Loumaye, our Chief Executive Officer.

Thank you, Mario. Good morning, everyone. On today's call, we will provide a business update, including clinical trial progress, second quarter of 2018 financial results and our outlook for achieving key future clinical milestones.

In the second quarter, we took several important step toward executing our strategy at: one, we met another major clinical milestone; two, made a key hire to begin pre-commercial training; and three, secured additional financing to support our ongoing clinical trial and future plans.

The second quarter of 2018 marks our second consecutive quarter with a major clinical trial readout, representing a transformational year for ObsEva in 2018.

Following the announcement of positive IMPLANT2, clinical trial result for nolasiban mentioned in February, we announced another positive trial result in June, the Phase II EDELWEISS trial of linzagolix for the treatment of endometriosis-associated pelvic pain. We are very pleased to release the execution of our clinical development program and the results produced for both IMPLANT2 and EDELWEISS trials, noting that we have more to come before the end of 2018, expecting the remaining 5 months of the year to be extremely busy on the clinical data regulatory and commercial readiness fronts.

I will now take a few minutes to provide an update and -- on all 3 of our company [niche] indications. First, I will review progress of our most advanced lead compound, nolasiban. In the second quarter, we first initiate the regulatory consultation with regulatory authorities in Europe and with U.S. FDA and second, made significant organizational advancement by hiring a Chief Commercial Officer.

Recall that we announced in February that the primary endpoint of IMPLANT2 was successfully achieved with a 10 weeks ongoing pregnancy rate of 35.6% for patient who received a one-time oral administration of nolasiban 900 milligram either on day 3 or day 5 embryo transfer, as compared to a rate of 28.5% for patients who received placebo, a 25% relative increase with a P value of 0.03. The data for patient undergoing day 5 embryo transfer was even more impressive, with nolasiban treatment resulting in the 10-weeks ongoing pregnancy rate of 45.9% versus 34.7% for the placebo, a 32% relative improvement with a P value of 0.03.

Now several months post initial results announcement, we have gained additional perspective on the data of the potential for nolasiban in the IVF setting, including at our IVF Q1 Investor Meeting in April, and last month at the European Society of Human Reproduction and Embryology Annual Meeting. We believe that the potential for nolasiban is only beginning to be appreciate, starting with the potential increase in pregnancy rate, representing a welcome outcome for couples suffering from infertility and secondarily, supporting the expanding practice of single embryo transfer.

We believe our strategy is well aligned with CDC goals, and it's having healthy babies initiatives and is support by unquestionable data on the much higher incidents of multiple births associated with double embryo transfer over single embryo transfer. Multiple pregnancies are often associated with serious health risks to both mother and infants due to premature birth and significant financial cost of (inaudible) births are estimate to rise from USD 100,000 to USD 400,000 or 5 to 20x that of single-term delivery.

Our aim with nolasiban is just to provide a simple treatment that can improve the odds of pregnancy during an IVF cycle, while also improving the health of both babies and mother and at the same time, potentially lowering total costs to the healthcare system. We continue to anticipate live birth rate result and 28 day neonatal follow-up from the IMPLANT2 trial early in the [first] quarter of 2018.

On the regulatory front for nolasiban, we are interacting with regulatory authorities in Europe and in the U.S. to finalize our future development plans and registration requirements. We're planning a U.S. Phase III trials, to be known as IMPLANT3, to begin before the end of 2018. We are also proposing to European regulators the filing of an MAA with IMPLANT1 and 2 trial full result, which includes up to 6 months of neonatal follow-up and 10 weeks pregnancy results from the IMPLANT3 trials. If accept, and pending positive outcome of IMPLANT3, our original European submission timing of second half of '19 will be met.

We continue to expect to communicate final regulatory feedback in our nolasiban clinical development plan in the third quarter of 2018. Further on nolasiban, we are pleased to confirm today that the IMPLANT2 trial results have been accepted for presentation at the Annual Meeting of the American Society for Reproductive Medicine or ASRM, taking place in Denver, Colorado October 6 to 10. The IMPLANT2 abstract has been accepted for oral presentation on October 9. We are looking forward to sharing this important data from the IMPLANT2 trial of nolasiban with such a large and important group of traditional researchers in the field of ART.

Finally, regarding nolasiban, I'm very pleased to reiterate our announcement last month, that Mr. Wim Souverijns will join ObsEva before year-end as Chief Commercial Officer based in Geneva. Wim comes with a strong and successful experience in market access, marketing strategy and sales force development in management acquired in Europe and in the U.S. His mandate is to prepare the company for the commercialization of nolasiban starting in Europe, which we believe ends in continued success in nolasiban development, could occur in late 2020 or early 2021.

We remind you that nolasiban will have no competitive product approved for the proposed IVF indication. It's an add-on to existing standard of care and the target IVF centers are of limited numbers. Altogether, this indicate to us that nolasiban can be successfully commercialized with a relatively lean infrastructure, which we will be assessing and planning over the coming months.

Moving now to our second lead compound: linzagolix. I will review our announcement that took place in June. Positive primary and secondary endpoints result for our Phase IIb EDELWEISS trial of linzagolix in the treatment of endometriosis-related pelvic pain. EDELWEISS is a Phase IIb randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety and efficacy of multiple dose of linzagolix in 328 woman aged between 18 and 45 with surgically-diagnosed endometriosis and who present with moderate-to-severe endometriosis-associated pain. Patient were recruit from 64 clinics in -- across the U.S. and Europe. Following a screening phase to establish a baseline pelvic pain level, woman were randomized to receive either an oral, once-daily dose of linzagolix, either 50, 75, 100 or 200 milligrams or placebo for up to 12 weeks. Additionally, patient with continued treatment for further 12 weeks followed by an optional 6-months extension period, allowed treatment for up to 1 year.

The primary endpoint of the EDELWEISS clinical trial was a responder analysis, with [symptoms] defined as an improvement from baseline of at least 30% in combined menstrual and non-menstrual pelvic pain, as measured by a 0 to 3 verbal rating scale or VRS. Pain was record on a daily basis via an electronic diary, and the primary endpoint was assessed over the last 20 days of treatment.

We announced in June that the EDELWEISS trials successfully met its primary endpoint of improvement of patient endometriosis-related symptoms as measured by a reduction of [pelvic] pain from baseline to week 12 of treatment. Observed response rate were 34.5% for placebo; 49.4% for 50 milligram; 61.5% for 75 milligrams; 56.4% for 100 milligrams 56.3%; for 200 milligrams. Respective P value were 0.15, 0.003, 0.039 and 0.034, highly significant.

Beyond successfully meeting the primary endpoint, we are also very pleased by the level of efficacy and the consistency of response to linzagolix in a list of secondary and exploratory endpoints, which include dysmenorrhea; non-menstrual pain; dyspareunia; dyschezia; as well as in instrument assessing patient well-being improvement such as Endometriosis Health Profile-30 score; Patient Global Impression of Change scale; Patient Global Impression of Severity; activity impairment score; and modified B&B score. In addition to strong efficacy, we are very encouraged by the tolerability and safety of linzagolix, with no indication of safety issue during the trial.

Regarding dysmenorrhea, the most frequent and painful symptoms of patients suffering from endometriosis, patient response rates at moderate and full suppression in estrogen dose of 75 and 200 milligram were 68% and 79% versus only 28.5% [versus] placebo, indicating partial estrogen suppression may be able to satisfy the needs of the majority of patient and that the higher dose with full suppression adds incremental benefits in only a small proportion of patient.

In addition, the strong response rates of the 75 milligram dose was equated with the rate of hot [flashes] of 18%, only slightly higher than the 11% in the placebo group.

We believe that this data strongly support our dual development strategy that [would] meet the need of the [board] and the [diverse endometriosis] patient population, the ability to either partially suppress estrogen without need for add-back therapy or to fully suppress estrogen associated with [some] add-back therapy. We believe that in endometriosis, partial suppression without add-back may be the appropriate treatment strategy for majority of patients. And the ability to those addressed effort can then address the needs of the remaining patient population.

Regarding differentiation within these new class of drug, we believe linzagolix is a potential best-in-class PK/PD profile, with a half-life conducive to once-per-day dosing, no food effect, high viability and low volume of distribution. In addition, linzagolix has not shown interaction with (inaudible) or OATP liver enzymes that can lead to complexity or drug work interaction and proliferance. Drug interaction can either increase or decrease drug exposure, which, in the context, can either lead up -- to efficacy gaps or unanticipated bone mineral density risks with existing estradiol suppression.

Following our positive EDELWEISS result, I would like to emphasize how pleased we were to see FDA approval last month of elagolix, the first compound in the oral GnRH receptor antagonist new class. We believe that the label is very supportive of this new class of drug, first, allowing for treatment duration up to 24 months without the need for add-back therapy that further validate the non-add-back regimen, the hallmark of our linzagolix development strategy and second, comes without a requirement for routine BMD testing.

From a commercial perspective, we are enthused about the prospective of the GnRH antagonist class and also believe that the antagonist has best-in-class potential, given the aforementioned PK/PD characteristics, our development strategy and linzagolix 75-milligram clinical data. With 2.5 million endometriosis patient diagnosed and treated in U.S. and with the potential for another 2.5 million or more to be diagnosed and treated upon the availability of new treatment alternatives, this population is appropriately sized to accommodate multiple new treatment option in our review.

Moreover, we perceive the patient population of endometriosis as well as uterine fibroids to very be much willing to seek treatment, given the highly symptomatic nature of this disease, which includes severe pain, bleeding and disruption of daily activity. We also expect physician to be very receptive to the efficacy and safety tolerability profile of this class of compound due to the shortcoming of existing treatment and alternative.

Treatment alternative are: first, injectable GnRH receptor [antagonists] such as Lupron, which cause an initial flare of symptom which can be very problematic for some patients and can only be used for full estrogen suppression with a 6-months duration limit; second, oral contraceptives primarily work by alleviating menstrual pain via bleeding reduction or menorrhea, and they have variable effectiveness; and third, NSAIDs are used for pain relief but are only partially effective, and wide use of opioids is due to be problematic due to abuse and addiction liability.

Finally, wrapping up on linzagolix, our uterine fibroids PRIMROSE 1 and 2 trials remains on track. These studies are 2 double-blind, placebo-controlled Phase III international clinical trials in woman with heavy menstrual bleeding associated with uterine fibroids. Planned enrollment is approximately 1,000 patients in total, with a primary endpoint of reduction in heavy menstrual bleeding as measured by standard alkaline hematin method. Last quarter, we indicated that PRIMROSE 2, with 70% of site in Europe and 30% in U.S., was on track for enrollment completion by the end of 2018. And our U.S. study PRIMROSE 1 on track for Q1 '19 completion. We believe that these project enrollment timelines remain achievable, and our expectation continues to be that PRIMROSE 1 and 2 will both generate 6-month primary endpoint in second half of '19.

Now onto our third pipeline program, the potential first-in-class oral and selective prostaglandin F2 alpha receptor antagonist named OBE022, being developed to treat acute preterm labor to prevent preterm delivery. This is presently a major need for new, safe and effective treatment option for the approximate 500,000 annual case of preterm delivery that occur both in Europe and in the U.S. Preterm delivery is associated with significant mortality and short- and long-term morbidity in neonate as well as huge economic burden on society.

Already in 2005, 13 years ago, data from the WHO indicates more than USD 26 billion were spent in the U.S. for preterm baby care, including stay in neonatal intensive care.

In late 2017, we began our Phase IIa proof-of-concept trial known as PROLONG. This trial is measuring PK safety and contraction inhibition, targeting delay of delivery by 2 days to 7 days in woman who are in acute preterm labor between 24 weeks and 34 weeks of gestation. PROLONG is currently being conducted in Finland and Spain, with OBE022 added onto the standard-of-care atosiban. The goal that we have initially conducted in Part A of the trial, in a non-randomized, open-label patient, to establish initial safety and PK parameter in pregnant woman before progressing to the randomizable, blind Part B of the trial.

We are pleased to provide an update on Part A of the trial today, in which all 5 patient, on whole, successfully achieved a goal of delaying labor for the 7-days treatment period. In fact, all 5 woman experienced a delay of weeks leading to a successful delivery or have not yet delivered. Even more important, there are -- been no safety or tolerability issue identified, which is an extremely important characteristic of a treatment in this population.

The initial PK assessment confirmed good absorption for the product, which prompt us to initiate the necessary regulatory steps to start Part B, continuing with the goal of receiving an initial interim efficacy and analysis from a subset of patient on Part B by the end of '18.

Summing up, we have made a significant pipeline progress so far in 2019, transforming ObsEva into a company with multiple late-stage development assets and now beginning plans to become a commercial company.

In addition to all of pipeline progress during the second quarter, I must also mention 2 major recent financial achievement. We complete follow-on equity offering of share to extend our cash runway and as so listed on the SWIFT (inaudible) Stock Exchange, to expand our investor reach and offer minority share on the [projects].

I will now turn the call over to our CFO, Tim Adams, to discuss these items as well as provide a financial overview.

Good morning, or good afternoon, everyone, and thank you for joining us on the call today. I will provide a brief description of our financial results for the second quarter of 2018 and our current cash position as of June 30, 2018.

Before reviewing the quarterly results, I would like to highlight the 2 recent events that Ernest alluded to earlier, our completed follow-on offering and listing on the SWIFT SIX Exchange. During the second quarter, we raised $87 million net of fees from our follow-on offering and our at-the-market, ATM, program.

As you may know, this was our first follow-on offering, and we were pleased with both the demand and the quality of shareholders we attracted. We issued 4.75 million shares, resulting in net proceeds of $68 million. In addition to the follow-on offering, we issued 1.6 million shares pursuant to our ATM program, raising an additional $19.4 million net of fees. I am pleased to report that we ended the second quarter with $166.8 million of cash on hand, and this now extends our cash runway into the first half of 2020. The financings come at an important time for ObsEva as we continue to make great progress with all 3 of our new chemical entities. And the extended cash runway funds our operations beyond some very important milestones for all 3 of our assets.

Our second major financial milestone occurred on July 13, when we officially listed our shares on the SWIFT SIX Exchange in Zurich. This was a proud moment for ObsEva as Ernest and the management team opened the market that day, and we saw a strong demand for ObsEva shares. We did not issue any new shares on the SIX but with secondary trading, have gained access to an expanded pool of investors as well as offering protection to minority shareholders that are afforded to domestic companies under Swiss law. As a Swiss company, we are very happy to have completed this important initiative.

And now let me take a few minutes to discuss our financial results for Q2 2018. I will start with the income statement. Our net loss for the second quarter of 2018 was $18.2 million or $0.49 per diluted share, which compares to a net loss of $17.3 million or $0.61 per diluted share in the second quarter of 2017. This increase in net loss during the quarter was primarily driven by investment in our research and development programs.

Research and development expenses were $14.7 million for the second quarter of 2018 compared to $14 million in the prior year quarter. This increase in investment is attributed to the clinical trial progress outlined by Ernest for all 3 of our development compounds.

G&A expense in the second quarter was $3.5 million compared to $3.9 million in the prior year quarter. This reduction in spending was driven by lower stock-based compensation costs. Our cash balance at June 30, 2018, was $166.8 million, which includes the $87 million of net proceeds from our equity financings during the quarter. Again, it is important to note that the financings extended our cash runway into the first half of 2020. This timeline allows for the achievement of the 6-month primary endpoint results from the PRIMROSE 1 and 2 trials as well as the expected completion of additional nolasiban clinical trial work and planned registration submission in Europe.

Our use of cash from operations in the quarter was $16.7 million. This increased investment level is consistent with our expectations that cash would trend upward from the approximate $15 million of cash used in the first quarter of this year. The expanded cash use reflects spending in support of all 3 of our pipeline assets, which includes the patient follow-up on our Phase IIb EDELWEISS study in endometriosis, ongoing Phase III enrollment of PRIMROSE 1 and 2 clinical trials in the treatment of uterine fibroids, the completion of live birth and neonatal follow-up in the Phase III IMPLANT2 clinical trial of nolasiban and patient enrollment in Part A of the PROLONG study of OBE022 in preterm labor.

Again, we are very pleased with the clinical trial progress and the support we received from investors during the quarter as we extended our cash runway.

Thank you for your continued support. And we will now turn the call back to the operator for questions.

(Operator Instructions) And our first question comes from the line of Martin Auster from Crédit Suisse.

I was hoping, Ernest, if you could maybe provide some kind of color around expectations for the upcoming 24-week results, specifically around the bone mineral density data, and kind of how you think this will help shape the profile of linzagolix relative to some of the competitors.

Yes, thank you for your questions. So in the 12-weeks data, we have the estradiol level, which are surrogate marker of possible impact on bone. I think we have discussed that in the previous press release. In short, we have clearly estradiol level below 20 picogram for the high dose, where full suppression is occurring. And for the 75 milligram, which performed extremely well in term of efficacy, we have median estradiol level, around 48 picogram per ml, which is at the upper end or mid-end of the 20 to 60 picogram window we are targeting. So really, this estradiol are telling us that it is likely that, indeed, at 24 weeks, for bone mineral density, we would see a significant impact on bone with the 200 milligram and then insignificant impact with 75 milligram. Obviously, pending the actual data, we will confirm that to you when the (inaudible) will be available. [Now in the term of] -- yes, so the second part of your question is how you differentiate. I think the 75 milligram has been performing very well, very well in the Phase IIb in term of efficacy. And as mentioned in this call, actually, we have close to an effect seen with full suppression for how many parameters. And therefore, I think that this is something which is unique or has -- there is one competitor with no program at all with the partial suppression. And we have elagolix with the partial suppression in endometriosis but only a full suppression with fibroids. So let's continue to track the data as they come. But it's really confirming our strategy, to focus as first line, directly, the non-add-back option.

And then I just said a kind of a brief follow-up to that. Just in terms of the end of Phase II meeting that you're planning, are there specific facets of the Phase III trial program that you'd like to -- you're thinking about designing for kind of label differentiation from products that are currently being developed or approved in the market? Or how are you approaching that meeting?

Yes, I mean, this obviously is an important meeting. One of the priority will be -- to be fully aligned with the FDA in term of defining the primary endpoint and that [pain] recording tools that we have been validated entirely with the EDELWEISS trial. In term of differentiation, I think that we are planning to have a long-term therapy with the non-add-back and to record additional paremeter, which has not been recorded by other companies like, for example, dyschezia, which is pain during defecation is really bothering the patient and has been classified by patient as a -- 1 of the top 3 most bothering symptoms. And we are the only ones who have record that. And we show a very significant improvement on that parameter. This is one example amongst other that we can discuss in more details in other setting. Does that answer your question?

Yes, Ernest. Appreciate it.

And our next question comes from the line of Kennen MacKay from RBC Capital Markets.

First one on OBE022 in preterm labor. Ernest, I was wondering if you could help us sort of understand the backdrops here. And from your perspective and some of the initial proof of concept data, what would be interpretable as sort of a positive result here? Result that is at least indicative of having an effect that may be beyond, for instance, placebo and something that could be robust in a randomized trial, if randomized trial is even needed in an invitation like this?

Yes, Kennen. So as I mentioned, we have a Part A, 8 patient open label. We are monitoring safety PK and efficacy. And then we will move to Part B, where we're placebo-controlled trial, double-blind, where we compare 60 patients with the treatment versus 60 patients with placebo, both on top of atosiban. Obviously, this is initial feedback on the first 5 patient, and by the way, we have #6 patient, which is ongoing now. But the assumption is the following. The assumption is that with preterm labor and preterm delivery risk, as defined in the protocol, we expect about 75% of subject not delivering with the standard of care. And we expect more than 90% with our product. So far, we have 5 patient non-deliver within the 7 days, and we continue to monitor that. So that's the expectation that should be how we driving the Part B conclusion in term of moving forward to the next steps. Does that answer your question?

Yes, it should have. And I appreciate you outlining those 2 strategies -- apologies, I had missed that. And then separately, on nolasiban, I was wondering if you could just sort of run through timelines of the regulatory interactions relating to -- within the U.S., relating to the Phase III trial one more time. Apologies, I think on my end that may have broken up a little bit. And then plans for the U.S. Phase III, is that going to focus only on sort of the D5 subgroup? Or will that also include some D3 patients as well, similar to the IMPLANT2 trial in Europe?

Yes, in term of regulatory timelines, both for U.S. and for Europe, we have actual dates -- official dates from the authorities to feedback on our proposal. We are not disclosing the specific date because we can always change the date a bit. But what we can confirm, that we will report on the feedback of authorities both in Europe and U.S. by end of the quarter. Regarding the IMPLANT3 trial, yes, we are focusing on day 5 embryo transfer, single-embryo transfer, to become consistent with our development strategy and to be consistent to the result of IMPLANT2, indicating that the best effect is seen on day 5 and because the field, the whole world is [progressingly] moving to day 5 single-embryo transfer as a standard of care. And U.S. is leading as it is currently the most advanced area in term of implementing that policy.

Got you. And maybe one additional follow-up on nolasiban. As we think about interpretation of pregnancy rates versus live birth rates, obviously, there had been some competition out there. And with the atosiban data in IVF, they had shown sort of a 51% clinical pregnancy rate, but that's certainly dropped to about 38.5% in their live birth rates. Can you maybe walk through some of the differences between how you are sort of defining or measuring pregnancy rate versus what atosiban has done? And how we should be thinking about the drop from pregnancy rates to live birth rates that atosiban saw versus how we should be thinking about the live birth rate for nolasiban?

Yes, that is a good question. I mean, what is important is the definition of clinical pregnancy rate. Because live birth, everybody agree, you have a baby, you're alive. So okay? So when you're (inaudible) first, [you give live birth]. No, but there is a nuance, I have to say because for Europeans, live birth is any baby born alive after week 24 and for the U.S. is after week 20. But that's a details because during that few weeks, you don't expect that [different]. So any possible difference between what we call clinical pregnancy versus live birth is relate on the definition of clinical pregnancy. And I think that in the atosiban, it's a net of original population, where you have a different timing of reporting what's a clinical pregnancy. Now we have used the most [clinical] definition, which is a live fetus demonstrate by ultrasound 10 weeks after embryo transfer, which correspond about 12 weeks of pregnancy. Why did we select that? For 2 reason. Why, it's because it is a criteria used by regulatory authorities, including in Europe to approve product. And two, it's because it's a period, which is completion of the first 3 months of pregnancy, after which pregnancy loss is usually minimal. So the discrepancy come from the definition of clinical pregnancy. Now we have reports of clinical pregnancy and live births in IMPLANT1, very, very small difference. And when you go to reference studies, like the one which compared 1 and 2 embryos, published in New England, which was really a key paper in the field for embryo transfer strategy. You see us saw the difference between the 10 weeks of post embryo transfer versus live birth rate is really -- the difference is really minimal. Nevertheless, we remain cautious, and we intend, as previously stated, to report the actual live birth rate in the very early beginning of Q4 this year.

Got you. Ernest. And maybe one follow-up on nolasiban if I may, and then I'll hop back in the queue. Just wondering, from a commercial perspective, if nolasiban is able to come to the market. And we do see another successful Phase III program here. I'm wondering if you could talk a little bit about sort of the competitive profile of nolasiban from the data that we have to date versus atosiban and maybe some potential tailwinds that nolasiban may [see there]?

Sure. So the first thing to be aware is that atosiban is not available in U.S. and will never be available in U.S. So it's not available for clinicians in the U.S. Atosiban is available in Europe and in some countries in Asia. In Europe, it is registered for preterm labor. It's not licensed. It's not registered for IVF use. And therefore, reimbursement will not apply to IVF use. I think, on top of that, the data generated with atosiban, although very, I would say, interesting and really supportive, has never been definitively and properly assessed. There are variability in response. There are variability in blinding. So I think it was interesting to attract a field to that area, but the quality of the data is not what -- the quality of the data we are generating. And therefore, based on the fact that there are no definitive data with atosiban, we will have definitive data, there will be no reimbursement of atosiban. And on top of that, this is an infusion of about 4 hours while nolasiban is oral administration, and you are aware that embryo transfer procedure is actually an ambulatory procedure. The patient come in, get the embryo and go home. But if you have to put the patient in a bed and do an infusion and use an infusion kit and so forth, this is making life more complicated and more expensive. So altogether, we've perceived that atosiban is a very low competitive profile compared to nolasiban in the countries where it's available. And clearly, for the U.S., it's a no-brainer because it does not exist.

Our next question comes from the line of Ram Selvaraju from H.C. Wainwright.

I was wondering if you could perhaps, Ernest, give us some color on what you think are likely to be the determining factors that would effectively specify how long patients being given a GnRH receptor antagonist would typically stay on therapy. Because it's clear that we have a situation in which some of these patients would intermittently be treated over the course of -- as many as 24 months. But what I'm more interested in is the continuous therapy window. Is that likely to be 3 months or 4 months? And in your estimation, what's likely to drive how long patients would stay on a therapeutic like linzagolix?

Yes. You'll remember, Ram, that the mean age at diagnosing endometriosis is around 30 years old. In the clinical trial, the mean age is about 32 years. So that means practically, this woman have to live for 20 years -- an additional 20 years with their conditions. For fibroids, it's more around 40, 42 years. It's about 5 years to 10 years, I would say, to go to menopause. So the occasion is very relevant, it's important to go long term. We are aiming, in the European, posttrial, to administer the product for 12 months, which means that is the regulatory criteria for long-term treatment, long-term meaning, no real limits. We are very pleased that with the 6-months data published for elagolix, this -- they got the 24 months labeled for the non-add-back option. Only the 6 months for the high dose but because in the Phase III -- initial Phase III program, it did not have add-back therapy, so no surprise [in that loophole]. But they are now generating long term. So -- now if you -- so I think for the non-add-back, we are going for long term. Now what about continuous versus intermittent therapy? I think we have to be realistic, and I would think that proactively, patient will be treated for 6 months to 12 months, maybe 18 months, and then feel much better. And then stop, and then maybe 6, 12, 18 months later, symptoms will come back because we know we are never going to cure. And they will restart a new treatment. So it's difficult to give you a precise -- [your life] will tell us later on. But I would think that this patient can be treated for 10 years or 20 years, not continuously, but for relatively long period, with some breaks, some day off, some drug off as they feel. We know from previous experience, there's another class which was (inaudible) that when you stop treatment for 5 years, for example, the symptom do not resume immediately. You have a period of grace, and then it's coming back. So we expect the same thing with our GnRH antagonist. So it's not very precise as an answer, but [I think that will reflect] the reality that we will aim at a label for long-term, whether it's going to be unlimited or 24 months or 36 months. Fine. But still, I think it's going to really address the need of these patients.

That's very, very helpful. And then a couple of other very quick items, if I may. Do you have additional information at this time from the EDELWEISS study, pertaining specifically to differences in pain medication consumption? I believe I had asked this before when the EDELWEISS data were first released, but you didn't have that information at that time. Is there any additional information you can share with us on this front now?

Yes, what I can tell you is that we have a dose-dependent significant reduction of painkiller. Now what we are still analyzing is what type of painkiller. How do you define an increase of painkiller or not? There is a showcase to be -- we are currently [analyzing] why. Because you know that the DFA wants to see the benefits unrelated to a significant increase in painkiller. And it's quite difficult to define because if you take one NSAIDs per months. And if you then take 2 pill of NSAIDs a month, is it an increase of 100%? Do you double it? Or if you take 25 pill, and you increase it to 30 pill, is that insignificant when it's only 50%? So you see, it's complicated. But what I can tell you that, for sure, there is a overreduction of painkiller -- whatever the type of painkiller, which is significant between placebo in a dose-dependent manner with linzagolix.

Okay, great. Very helpful. And then on nolasiban, I just wanted to revisit the timeline you expect for the second Phase III trial in terms of how long do you anticipate it would it take to conduct enrollment, when you expect to start enrollment and when you expect to get top line data? And if you can confirm whether the live birth rates data, which is expected in the fourth quarter, is information that you would be in a position to disclose at the ARM (sic) [ASRM] conference in Denver. Or is that slightly to be something you release after that?

We will be able to release at the ASRM. And the current assumption is from start to primary endpoint is going to take about 12 months for the trial based on the IMPLANT2 experience, yes.

Okay. And then one quick question for Tim. Tim, can you just confirm that you don't anticipate there to be any significant changes in stock-based compensation on a quarterly basis going forward? Or if there are, what changes do you expect there to be?

Yes, Ram, I think we're at about $4.5 million year-to-date, and that number should be relatively consistent for the second half of the year.

And our next question comes from the line of Keith Tapper from BMO Capital Markets.

I'm calling in for Do Kim. Wanted to check in about the pricing so just the price of elagolix in line with your pricing strategy and whether you think, at that level, it will be an obstacle for reimbursement.

We are talking about the price in the U.S., as there been some information in the media -- specialized media about the price that elagolix may ask or propose. We cannot comment on that because, obviously, we are not in control. What I can tell you is that the price that we heard in the media is significantly above our baseline assumptions, which is a -- good news. And there is no -- it's too early to decide when we'll be on the market, whether we align or not to their price. But it's definitively well above our baseline assumptions. So it's a -- positive news.

And our next question comes from the line of Kennen MacKay from RBC Capital Markets.

Just another quick follow-up on OBE022. Wondering if you can sort of comment on enrollment into Part A of the trial and maybe anything that sort of you've learned from the enrollment process and strategy there that could enable tailwinds in enrollment in Part B. And moving forward here, obviously, preterm labor is a little bit of -- sort of a crisis situation. And getting patients enrolled, theoretically, could be a challenge. Although it seems like you've certainly done a good job with Part A here. So just any detail there, I think, would be very helpful.

Yes, yes, I mean, you're absolutely right. It's a challenge in recruitment because, as you allude to, it's an acute situation when you ask a patient to sign a 2-page informed consent and to take new drugs. And she's thinking about losing her baby or risk of losing her baby. So I think that's -- now the recruitment in Part A have been good, a little bit slower than we expect. But we see a positive impact because as we accumulate data now on the 6th patient, it's really encouraging. The 2 centers who are running the Part A -- because the staff is more and more confident, and they can already tell the patient, "Look, other patient have been treated and has been well. It has been safe," and so forth. So I think it's a victorious process. Nevertheless, we should not underestimate the difficulty. And that's why we have aligned a list of center which are not only additional centers in Spain, continued in Finland but also open center in Israel, Ukraine and Russia if I remember well, [Jean-Pierre]? As well as Vietnam, where we [identify] a hospital which is dealing with 35,000 delivery per year. So if 10% are preterm delivery, you imagine the number of the day of preterm delivery. So in other words, yes it's challenging. We are taking measure to, I would say, alleviate this challenge. And I think it's going to be a victorious process because more data, more good result, easier or relatively easier it will be to enroll patient. We still need time to release and to analyze some initial Part B data by the end of the year. We'll see how we progress and what we can do. But that's our objective.

Our next question comes from the line of Biren Amin from Jefferies.

Just one on the nolasiban, have you discussed with the EMA on the design of IMPLANT3 and acceptability of this design for the MAA filing?

Yes, we have discussed that. We are discussing that. And we will report by the end of the quarter. But yes, we have discussed that as part of the consultation. Yes.

And Ernest, so day 5 would be acceptable to the EMA?

I mean, the process is ongoing. As you know, they -- we don't choose the centralized scientific advice process, which is written interaction more on specific protocol characteristics. So the process in Europe is to actually talk to national authorities, which are anticipate to be most likely the rapporteur and co-rapporteur, which are the 2 countries which will be mended on behalf of the 27 countries to defend and present the dossier at the centralized procedure. So we are talking to Holland and Sweden because they have -- they are well known and recognized for their expertise in woman's health. And by the way, (inaudible) we'll work with them. And so this is ongoing. So I cannot, and I don't want to anticipate a premature conclusion. But again, we are confident that [we'd be released] that final opinion from these 2 countries by the end of the quarter.

And I'm showing no further questions. I would like turn the call back over to Ernest Loumaye for any closing remarks.

Thank you. Hold on 1 second, I have to go back to my concluding remarks. Right. So first, to thank everyone for taking the time to join ObsEva's Second Quarter 2018 Update Call. As you heard, we have outlined today very significant recent progress with all 3 development compounds as well as expanding the commercial and financial capabilities of the company. We are moving towards our goals of providing potential best-in-class therapeutical alternative across a range of woman's disease and fertility condition. We look forward to providing further important update on each of our development compounds over the remaining 2018, including: one, presentation of the IMPLANT2 result of nolasiban to increase pregnancy rate during IVF procedure at the ASMR meeting, in addition, to launch first-rate data from the trial in (inaudible) on the regulatory fast forward by the end of the quarter; two, the 24 weeks result from the EDELWEISS trial of linzagolix in endometriosis-associated pain, including and most importantly, the BMD data; and third, the initial efficacy result from the PROLONG Phase IIa trial of OBE022 for the treatment of acute preterm labor.

So thanking you again. As always, I'll remind you that you can reach Tim Adams and Mario Corso for any follow-up questions. And this concludes our call. Thank you.

Ladies and gentlemen, thank you for your participation in today's conference call. This concludes today's program, and you may all disconnect. Everyone, have a great day.