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ObsEva SA (OBSV) Q2 2019 Earnings Call Transcript

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OBSV earnings call for the period ending June 30, 2019.

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ObsEva SA  (OBSV -4.08%)
Q2 2019 Earnings Call
Aug. 07, 2019, 5:00 p.m. ET


  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:


Welcome to the ObsEva Second Quarter 2019, Financial Results and Business Update Conference Call. All participants are currently in listen only mode. Following management's prepared remarks we will hold a Q&A session. (Operator Instructions). As a reminder, this call is being recorded today, August 7th, 2019.

I would now like to turn the conference over to Mario Corso. Please go ahead.

Mario Corso -- Senior Director of Investor Relations

Thank you, operator. This is Mario Corso, Senior Director, Investor Relations at ObsEva. Good morning to our listeners in the US and good afternoon to those of you joining us from Europe. Welcome to today's call to review ObsEva's Second Quarter 2019 Financial Results. On this call, I'm joined by Ernest Loumaye, our Co-Founder and Chief Executive Officer; Jean-Pierre Gotteland, our Chief Scientific Officer and Head of R&D; Wim Souverijns, our Chief Commercial Officer; Tim Adams, our Chief Financial Officer; and Beth Garner, our Chief Medical Officer.

During today's call, ObsEva management will be making 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 oxytocin receptor antagonist, Nolasiban; our gonadotropin-releasing hormone receptor antagonist, linzagolix, formerly, OBE2109 and our our prostaglandin F2 alpha receptor antagonist, OBE022.

These forward-looking statements will include comments about expected clinical trial results and regulatory pathways in the US, Europe and Asia, as well as the therapeutic and commercial potential of ObsEva's products. These forward-looking statements are based on ObsEva's current expectations, and they inherently involve significant risks and uncertainties, ObsEva's actual results and the timing of events could differ materially from those anticipated in such forward-looking statements. Risks and uncertainties include without limitation. those related to ObsEva's development programs, clinical trial timelines 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 filings with the US. Securities and Exchange Commission, including a 6-K report for the three months ended June 30, 2019, to be filed on or around August 7th, 2019, as well as other reports filed on form 6-K and 20 F. ObsEva undertakes no obligation to update any forward-looking statements as a result of new information, future events or changes in expectations, except as required by law.

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

Ernest Loumaye -- Co-Founder and Chief Executive Officer

Thank you, Mario. Good day everyone. I'm pleased to report that the second quarter of 2019 was busy and productive, and that ObsEva continues to execute against its milestone across all of our programs. Today, we would be reviewing the status of all three of our new chemical entities in development as well as looking ahead to key clinical milestones expected later this year, which begins our exciting evolution to a commercial company.

I'm now so pleased to confirm, that today we announced the closing of a $75 million senior security credit facility, with Oxford Finance LLC, a non-dilutive financing, which significantly strengthens ObsEva financial position by extending our cash runway into the first quarter of 2020. Our CFO, Tim Adams, will provide further commentary later on this call.

Now to our pipeline, we've been particularly active with Nolasiban, our compound in development, to improve the success rate of embryo transfer or ET following an in-vitro fertilization, for patients with infertility. So our pipeline candidate closes to commercialization. As background, infertility is a global challenge of increasing importance. It's currently estimated that, worldwide infertility affect about 10% of reproductive-aged couples, and more than 2 million ART cycles are performed each year globally, a number that is certainly growing. Although treatment for infertility has continued to improve over the years, one area that remains challenging is the embryo transfer process, which continues to have unacceptable rate of failure. There is a need for innovative treatment that increase the likelihood of successful embryo transfer, and we believe nolasiban has the potential to fulfill these needs.

We have made excellent progress on our nolasiban program. On June 4, we announced completion of patient recruitment in IMPLANT 4, our confirmatory Phase 3 European registration trial. We are initiating IMPLANT 4 in December of 2018, and as a whole, approximately 800 patients, who are undergoing a day 5 fresh single embryo transfer, which involves more than 40 centers across Europe, Russia and Canada. There is an extremely high level of interest in Nolasiban from both patients and physicians. IMPLANT 4 fully enrolls in six months, similar to our previous Phase 3 trial, IMPLANT 2.

We are pleased to confirm to-date, that we remain on track to announce results from the primary endpoint, ongoing pregnancy at 10 weeks possible transfer during in the fourth quarter of 2019, assuming positive results are managed to proceed with the marketing authorization application filing in Europe prior to the end of 2019 and we have already begun assembling the dossier.

During the second quarter, we announced a final safety follow up from the IMPLANT 2 trial, which showed no difference from placebo in development of health of infants, followed for six months post-birth, as measured by the Age & Stage Questionnaire Third edition or ASQ-3 score.

We are very pleased that extensive safety follow-up from the IMPLANT 2 trial, including pregnancy, delivery, and infant stages at 28 days and six months plus birth, did not show any safety issue related to nolasiban treatment. It is consistent with our expectation that the window for the therapeutic effect of Nolasiban is at the optimal time in the embryo transfer process.

Regarding Nolasiban in the US, we participated in a very constructive End-of-Phase 2 meeting with the FDA, during the second quarter, to discuss the design and scope of the phase redevelopment program. Based upon this discussion, we plan to submit an undated IND and trial protocol this quarter, with the goal of beginning the US Phase 3 IMPLANT 3 trials in the fourth quarter. We are pleased with the progress that we have made in finalizing the pivotal trial design, and look forward to getting started as soon as possible.

We continue to believe Nolasiban has great potential to significantly impact women experiencing the challenge of infertility. As I described earlier, infertility is a growing problem globally, which we note is a global challenge of increasing importance. The largest market are Europe and China, at approximately 800,000 annual treatments cycle each, with another 260,000 cycle per year in the United States. We view China as one of the three most promising geographies for Nolasiban. Indeed population trends suggest that China is likely to have the world's largest IVF market in the near future. The market assessment that we commissioned is very encouraging and that IVF cycles in China are done on a cash fee basis, with the cost of related drugs and services comparable to what we are seeing in Europe. So a very established and sophisticated market in China.

Our strategic assessment concludes, that development and commercialization in China would be best conducted by a multinational company with extensive local experience and resource. We have been exploring this strategy, with a corporate objective to have a partner in place by the end of the year.

Before we move on from Nolasiban, I want to share a few highlights from the key opinion leader or KOL event we held on July 17 in New York, from investors and analysts on trends in embryo transfer and IVF, and the potential of Nolasiban. We were honored to have three accomplished leaders in the field of IVF US discuss current clinical practice and how Nolasiban could play a role, if available in the future.

Overall, we were pleased to hear, that our development strategy for Nolasiban is well aligned with current IVF practice trends toward Day 5 embryo transfer, as well as the important merits of single embryo transfer versus double embryo transfer. Wim will talk about this more in a few minutes. Discussion also include 30 meaningful benefits of potential, 11% absolute increase in live birth following Day 5 embryo transfer that we've observed in the IMPLANT 2 trials. Importantly, the KOL recorded an absolute increase of 5% or more in live birth rate it as clinically meaningful.

Finally, clinician emphasis from the patient perspective to significant physical, emotional and financial pain associated with swelling and IVF cycle. The webcast link to this highly informative even can be found on our website and I recommend everyone to listen, if you are not able to participate.

Let's move now to linzagolix, which we are developing as a potential best in class oral GnRH antagonist for both uterine fibroids and endometriosis situations. We believe our strategy is unique to develop linzagolix in post indication, with an option to control symptoms without the need for add back therapy. This is in addition to a standard dosing option with full estradiol suppression that would be administered in combination with add back therapy.

With this approach, we aim to provide patient and providers with a wider range of treatment option, that may allow for greater flexibility in the choice of therapy, for individual patients based on their specific needs.

Our two Phase 3 trials for the treatment of heavy menstrual bleeding due to uterine fibroids; PRIMROSE 1 and PRIMROSE 2; continue to progress during the second quarter. Both trials have now completed patient recruitment of approximately 500 patient each, and we continue to expect a six month primary endpoint results from PRIMROSE 2 trial in the fourth quarter of 2019. We expect to report primary endpoint results from US trial PRIMROSE 1, shortly thereafter in the first half of 2020. The timing of these data readouts continue to support our planned US and EU regulatory submission in May 2020, which assume data with 12 months of treatment for chronic indication.

What makes us so excited about linzagolix in the uterine fibroid syndication, is to fulfill the promise of the GnRH receptor antagonist mechanism of action. Achievement of symptomatic relief to partial estrogen suppression, resulting in a need for add back therapy to protect bone from estrogen related BMD decline. Clinical data suggests that full estrogen suppression can alleviate heavy menstrual bleeding patient, but with the drawback of unnecessary decline in BMD at a level of 2.5% to 3% or even more in some patients, which necessitates add-back therapy for bone protection.

Our novel partially suppressed estrogen utilizing linzagolix, optimal PK/PD properties. If dosing with 100 milligram in linzagolix results in a 40% to 50% patient response rate with BMD remaining in the safe zone, this could uniquely position linzagolix as the de facto first line GnRH receptor antagonist for the treatment of uterine fibroids.

We believe this is a differentiated and scientifically sound strategy, that could avoid the use of add back therapy in a significant proportion of patients, who may not need it. After all, add back therapies, to standard [Phonetic] post-menopausal hormone replacement therapy, which carries a black box warning for the risk of cardiovascular events, cancer and dementia. Even if these risks may be there, we nevertheless believe it's highly preferable to avoid exposing patients to HRT, who do not need it.

Furthermore, clinicians may have concerns regarding potential reduction of symptoms, reduced associated with add back therapy. Of note, beyond the well established primary endpoint, the PRIMROSE study will also evaluate a number of important secondary endpoints, which include fibroid related pain and quality of life. These additional endpoints reflect some of the important additional symptoms and issues, that affect the daily life of patients with fibroids. We look forward to generating this important data, just a few months from now.

Moving to endometriosis, during the second quarter, we announced long term follow-up results from the EDELWEISS trial. These include patient dose for 52 weeks, as well as patients who were followed for six months of treatment, after receiving linzagolix for a six month treatment period. The 52 weeks data was consistent with the initial six months result, showing durable efficacy and the BMD impact that could be expected for partial and full suppression of the estrogen.

The six months follow off treatment, we read two interesting observations. First, there seems to be a an efficacy over effect even after the termination of the treatment. Secondly, BMD appears to rebound rapidly, after stopping treatment with higher antagonist dosage.

The first half of 2019, we initiated two Phase 3 trial for endometriosis associated pelvic pain, known EDELWEISS 2 and EDELWEISS 3, which combined with -- enrolled approximately 900 patients in the US and Europe. As with uterine fibroids, we are studying two doses, one that can achieve such partial suppression without add back therapy, and full E2 suppression with add back therapy to protect bone. This refined our Phase 2B data we believe, that the maturity of endometriosis patient maybe able to achieve a response rate, indicative of symptomatic relief with a lower dose and partial suppression, avoiding unnecessary exposure to the drug by risking those patients, who do not need it. Now two years into the Phase 3 development of linzagolix, we are more convinced than ever, that we are pursuing the right strategy with the right compound to meet the needs of women suffering from this debilitating disease.

Now let's turn to our third clinical program, the oral prostaglandin F2 alpha receptor antagonist OBE022, which is being developed for the treatment of acute preterm labor, a problem for which the short and long term health and medical costs are extremely high and there is substantial unmet need for safe and effective option. OBE022 is being evaluated in a proof-of-concept Phase 2A trial being conducted in two parts, part A and part B. In late January, we announced results from part A of the trial, which showed that OBE022 was very well tolerated by mother and fetuses, and demonstrated that the pharmacokinetic of the drug are similar to those previously observed, in non-pregnant women. In addition, eight of nine patients, using a single arm combined OBE022, which is standard of care atosiban, did not deliver 27 days dosing period.

Part B of the trial began in the first quarter of 2018, and is a multi-center randomized double blind placebo-controlled parallel group trial, that will enroll up to 120 patient with preterm labor at the gestational age of between 24 and 34 weeks. The trial design assess efficacy, safety and pharmacokinetics. Efficacy is defined as a delay of preterm delivery by at least seven days, allowing for treatment of the mother and fetus to protect organ development.

Part B will receive either OBE022 or placebo, with a starting dose of 1000 milligrams initially, followed by 500 milligrams twice a day for seven days, to women already receiving atosiban infusion for 48 hours.

We were happy to see the Part A results led to expansion in participating countries and centers of the trial. We recently achieved the enrollment of 30 patients in Part B, that triggered the first interim analyses by the IDMC. The IDMC recommendation was to continue to trial as planned, with no such modifications to trial design, which we consider to be very encouraging.

As we have previously stated, we anticipate making a no go decision on the further development of OBE022 later this year, based upon the results of the first 60 patients enrolled in the trial. In summary, the second quarter of 2019 was another quarter of important progress with three new chemical entities in our pipeline, and we are moving toward major milestones for each later this year.

Before I turn the call now over to our Chief Commercial Officer, Wim Souverijns, to update our commercialization plan, I would like first to introduce the newest member of ObsEva senior management team; Chief Medical Officer, Elizabeth or Beth Garner. Beth comes to us with great experience in the field of women's health and at a critical time, as we continue to expand our clinical development program, and we start preparing our marketing authorization [Indecipherable]. We would like to thank our previous CMO, Elke Bestel, for all of her hard work, and she will continue the vital role as Head of Pharmacovigilance, overseeing the safety of all our products.

Now a few words from Beth, Beth?

Elizabeth Garner -- Chief Medical Officer

Good morning or afternoon, everyone. I'm delighted to have joined the ObsEva team. I joined ObsEva because of its unparalleled commitment to improving women's health and fertility. As an OB/GYN, I believe the company is poised to have a substantial impact on some of the most challenging reproductive health condition women and their healthcare providers deal with everyday.

A little about myself; I received my MD and MPH from Harvard and trained and practiced at Harvard Major Hospital, Brigham and Women's and Massachusetts General. I first entered industry 12 years ago, working on the HPV vaccine program at Merck. I then worked on the elagolix program at Abbott, spent two years in medical affairs at Myriad Genetics, and for the last five and a half years was Chief Medical Officer of Agile Therapeutics, a women's health company focused on contraception.

I'm looking forward to helping ObsEva maximize the potential of its highly innovative development pipeline, endeavoring to bringing new treatment alternatives to patients in need. I'm very happy to be here and I look forward to working with all of you.

I will now turn the call over to Wim, for a commercial update.

Wim Souverijns -- Chief Commercial Officer

Thank you, Beth, and a very warm welcome aboard. It has been an exciting nine months since I joined ObsEva, and we're making tremendous progress with each passing month. My primary focus has been of the race of the company for the commercialization of Nolasiban in Europe, which if all goes according to plan, is less than 18 months away.

We're confident that with a strong foundation, including a growing infrastructure and a well-defined position in the market, we're on the road to success. More specifically, we have make good progress in the hiring of the three global core functions; market access, marketing and medical affairs. And we've begun mapping European IVF landscape on a country-by-country basis.

We're developing strategic plans to position Nolasiban as the next frontier of infertility treatment, offering a potential step change in the success rate of embryo transfer following IVF.

Recognizing that the field of IVF is as much about people and their desire for a baby, as it is about science, we focus also on evaluating the impact of cycle failure on individuals undergoing fertility treatments, as well as the peers, who covered the associated costs. We believe that the value proposition associated with Nolasiban's potential to increase live birth rates is fresh day 5 single embryo transfer by approximately 35%, based on IMPLANT 2 results is highly attractive. Patient and clinicians alike can experience higher success rates, lessening the emotional, physical, as well as financial pain or cycle failure.

Healthcare payers, on the other hand, can reduce their costs, thanks to increased productivity of IVFs, i.e., fewer cycles needed to produce a baby, as well as the savings coming from less emotional distress on patients and reduction in multiple pregnancies. The KOLs at our investor event, clearly recognized the different value drivers of the product.

Our initial interactions with peers in several European countries, lead us to believe that the potential benefits of Nolasiban and its associated value proposition will be well received. Our primary focus is now on formalizing the pharmaconomic analysis in support of Nolasiban.

We are also in the process of preparing the recruitment of local talents to further plan market access and launch. The major markets of Europe and the US, hold great promise for us and we believe a relatively lean commercial organization can address the opportunity in these markets, given the concentrated nature of IVF centers.

As I said, we've made tremendous progress in my nine month at ObsEva, and we eagerly anticipate IMPLANT 4 trial results later this year, which, if successful, will open our path to commercialization.

Now let's move to linzagolix. As a first readout from the Phase 3 PRIMROSE trial, linzagolix in uterine fibroids later this year draws closer. We continue to watch closely the commercial evolution of the GnRH receptor antagonist class, as well as any clinical data releases. We are highly focused on linzagolix best in class potential for both uterine fibroids and endometriosis indication, and our belief is potential for differentiation is increasing.

Recent developments have strengthened our view, that the best way to address the needs of the broad patient population in uterine fibroids and endometriosis, is to offer two dose options. At first line, there is an option without the need for hormonal add back therapy. And a second line, higher dose with full estrogen suppression given with add back therapy to protect from bone loss. We are the only company developing such a low dose, no add back therapy option for uterine fibroid indication. Our Phase 2B data in endometriosis indicated that the 75 milligram dose of linzagolix is nearly as effective as a 200 milligram dose. So alleviating symptoms with a partial suppression dose for both indications, with the option to dose higher as needed, will be perfectly aligned with the way that physicians practice medicine in these diseases.

As chronic diseases, women have to learn to cope with their symptoms, sometimes for many years. Therefore, rather than have to start with a three drug regimen of GnRH antagonist and add back therapy, clinicians and patients choosing linzagolix would have the option to initiate treatment with a low dose, and no add back therapy. Titration to the higher dose, with the addition of add back therapy could then be implemented after assessing individual women's response.

We believe that the decision to use add back therapy or a hormonal replacement therapy should be carefully considered. Since although it provides the benefits of bone protection, it also has no drawbacks, which is definitely -- potentially not appropriate for all patients. Ultimately, we believe that physicians and patients should be provided with the opportunity to make these important treatment decisions together.

So stay tuned for our six month primary endpoint results of the PRIMROSE 3 trial, which will provide insights into the profile of the lower 100 milligram dose, as well as the higher 200 milligram dose, both with and without add back therapy. Positive test results and additional data on continued patient follow up, the timeline for late 2020 NDA filing for uterine fibroids remains intact.

Finally, we're encouraged by the endorsement of the IDMC to continue the PROLONG study. Although OBE022 is at the earliest development stage of all our compounds, it addresses a major unmet need, as safe and effective therapeutic options to hold preterm birth are very limited, and costs related to pre-term delivery and neonatal ICU hospital stays are very high. So we're patiently looking forward to the data later this year for our go/no go decision.

So on that note, I will now turn the call over to our CFO, Tim Adams, for a brief financial review.

Tim Adams -- Chief Financial Officer

Thank you, Wim. And thank you everyone, for joining us on today's call. I will first spend a few minutes discussing our financial results for Q2 of 2019, and then discuss our cash position and outlook.

Our net loss for the second quarter of 2019 was $34.8 million or $0.80 per share. This compares with a net loss of $18.2 million or $0.49 per share for the second quarter of 2018. The year-over-year increase in net loss was largely attributed to increased spending on the clinical development for nolasiban and linzagolix, and to a lesser degree, professional fees related to market research and pre-commercial activities, staff costs and equity based compensation.

Research and development expenses were $28.4 million for the second quarter of 2019 versus $14.7 million for the second quarter of 2018. This increase resulted from the expansion and continued progress with the clinical trial development for nolasiban and linzagolix. As you may recall, we are currently conducting five Phase 3 clinical trials supporting nolasiban and linzagolix.

G&A expense in the second quarter of 2019 was $6.2 million, as compared to $3.5 million for the second quarter of 2018. This increase is primarily attributed to higher staff costs and pre-commercial activities for Nolasiban. Our cash balance as of June 30, 2019, was $98.5 million, compared to $138.6 million at the end of 2018. Cash used in operations during Q2 was $19.6 million and reflect spending in support of all three of our pipeline assets, which includes, the patient follow up for our Phase 2b EDELWEISS 1 trial in endometriosis, as well as the commencement of the EDELWEISS 2 and 3, Phase 3 trials.

The ongoing Phase 3 enrollment and follow up for the PRIMROSE 1 and 2 clinical trials for the treatment of uterine fibroids. The enrollment of the confirmatory Phase 3 IMPLANT 4 trial of nolasiban. Enrollment in Part B of the PROLONG trial of OBE022 in preterm labor and initial pre-commercial spending related to Nolasiban for the IVF indication in Europe.

I am pleased to report that earlier today, we announced the completion of a $75 million credit facility with Oxford Finance. As you know, non-dilutive financing has been a high priority for us, as we continue to invest in our promising pipeline, and extend our cash runway. The funding is available to us in three $25 million tranches, with the initial funding due at closing. The second and third tranches will be available at our option, upon achieving clinical data milestones. Access to this capital provides us with additional cash runway, and the flexibility to opportunistically utilize other financing vehicles, such as, the equity capital markets, should we choose to do so. The loan has a five year term with interest-only payments due during the first 36 months. The interest rate is 30 day LIBOR, plus 6.25%, which today is just under 9% all-in. This provides us with an attractive cost of capital relative to the various financing alternatives that were available to us.

Our use of cash from operations in the first half of 2019 was $40.6 million, which we expect to accelerate in the second half of 2019, due to continued R&D investment. Our full year cash use expectation has been increased modestly to approximately $105 million to $110 million. This increase from approximately $100 million, primarily includes additional investment for Nolasiban development, pre-commercial and China partnership activities. Assuming full access to the $75 million credit facility announced today and including our updated budget, we now believe that our cash runway extends into Q4 2020.

In summary, we are very pleased with our progress to-date and we'll continue to invest in our promising pipeline, that includes five ongoing Phase 3 trials and plans to begin a sixth trial before the end of the year. We are also preparing for the potential commercialization of our first product, Nolasiban in Europe, which may be now less than 18 months away. With our existing resources and the Oxford transaction announced today, we are in a strong position to pursue our strategic plans.

Operator, we are now ready for questions.

Mario Corso -- Senior Director of Investor Relations

Operator, I think we lost the end of that.

Questions and Answers:


[Operator Instructions]. Our first question, we do have a question from the line of Ami Fadia with Leerink. Your line is now open.

Ami Fadia -- Leerink -- Analyst

Good morning. Thanks for the question. Maybe the first question is -- maybe for Ernest; with the Phase 3 data for uterine fibroid expected later this year, can you help us compare the primary endpoint with some of the other Phase 3 studies reported out by either Orilissa or relugolix and give us a sense of how we should compare the efficacy data points that we see from the study across trials, of course, with the caveat that there's only so much you can compare? And also maybe, you know what level of efficacy you're looking for, as you sort of see that data? And you know, if the low dose also demonstrates sufficient efficacy, what are your expectations with regards to the duration of use that you can get on the labor from the FDA? Thank you. And I have a follow up for Tim later.

Ernest Loumaye -- Co-Founder and Chief Executive Officer

Okay. Sure. Sure. So all three GnRH antagonists are addressing the main symptoms of fibroids, which is heavy menstrual bleeding. This heavy menstrual bleeding often lead to anemia. So this is a serious condition. The way we are measuring the bleeding and reduction of menstrual bleeding, is standardised and validated, which is the alkaline hematin method, that mean that the sanitary material are collected by the patient and sent to a central laboratory. It's the same method used by all three GnRH agonists, and that's a method approved by the FDA. So we would be able to directly compare primary endpoints between the different generation antagonists.

What may differ in some case is the severity at baseline, which may have an impact. But I think that we are all going for heavy menstrual bleeding, which means bleeding, with 60 to 80 milliliter for 28 days.

So now, what are our expectations? We are developing, as mentioned, a low dose, no add back option, which is 100 milligram, and high dose add back option, which is 200 milligram. I think the 200 milligram plus add back should compare well to the other and we are expecting to have a respond rate around 70% of patients. Now, should we reach the same level of response for add back therapy? We believe that would be good, but it's not mandatory and it's not necessary. Given the drawbacks of add back therapy, we believe that anything around 40% to 50% of responder rate with no add back, we will make that option first line therapy. If we can already see half of the population to be treated with a single drug and not three drugs, i.e., the antagonist plus estrogen plus progestin of add back therapy, this would make de facto, a first line therapy. Does that answer your question?

Ami Fadia -- Leerink -- Analyst

Yes, I think that's very helpful. And if you were able to get that target responder rate for the low dose, do you think that that could allow for a label without any limitations of use and really mostly on physician discretion?

Ernest Loumaye -- Co-Founder and Chief Executive Officer

No, that's probably a little bit too early. But we are generating a data for one year, and generating data with one year if positive, which support for long term feedback. Now like for endometriosis, with this class of drug, we would like to treat for a couple of years, certainly. But we don't expect also, the patient will be continuously be treated for 15 years for example, because the time there is minimal. And in that context, I think the data that we have in the endometriosis EDELWEISS trial were very interesting, because there was a carryover aspect of the Phase 2 [Phonetic] when we stopped a drug. So, yes, we are in this long term. We are producing data of one year, which should support our long term if positive, and we have the objective to treat as long as possible, but we can think also that in the future, and in practice, you would go for a treatment of one year, two year or three years, then a drug holiday, and then [Technical Issues]

Ami Fadia -- Leerink -- Analyst

Got it. Okay, that's very helpful. Maybe just a second question for Tim. With the $75 million funding that you've announced this morning, how does that put you in position to support a win that you need to do with the late stage pipeline? It sounds like -- it allows you to sort of finance the ongoing studies, does it also cover for the potential start of the Nolasiban US study, as well as the commercial launch requirements in Europe? Thank you.

Tim Adams -- Chief Financial Officer

Okay. Yes. Good morning, it's Tim. So the $75 million credit facility, which we're thrilled to have in place, extends our cash runway into Q4 of 2020. As you know, we have two very important data readouts in Q4 of this year. The IMPLANT 4 study for nolasiban, and the PRIMROSE 2 readout for uterine fibroids.

As we move into 2020, we will be running five Phase 3 studies. Hopefully study number six, which would be IMPLANT 3, would be up and running. So let's assume IMPLANT 3 is up and running. So during the course of 2020, you're funding six Phase 3 studies. So we're gonna be quite active. And this cash runway really extends us about a year beyond the important data readouts that we have at the end of this year. We will begin some pre-commercial launch next year. We've done a little bit of that this year. Once we have positive data on IMPLANT 4, then we will increase the investment, as Wim has a lot of work to do for Nolasiban in Europe, and he will go -- really start those activities at a higher velocity in calendar 2020. So it allows us to accomplish a lot of things that we want to accomplish. But certainly extending the runway beyond the data readouts of Q4 this year is certainly very important to us.

Ami Fadia -- Leerink -- Analyst

All right. Thank you.


Our next question comes from Martin Auster with Credit Suisse. Your line is now open.

Mark Connolly -- Credit Suisse -- Analyst

Hi, everyone. This is Mark on for Marty. Thanks for taking my questions. So two related to the debt agreements, which we are pleased to see that you are able to get. So the press release mentioned that the debt is due August 1st, 2024. I'm curious if there are any terms in the contract that require repayment sooner than that date, and what those terms are? And then second, I guess, do the terms of the debt agreement impact your ability to pursue other non-dilutive financing strategies? Thank you.

Tim Adams -- Chief Financial Officer

Yeah, Mark, it's Tim. So I would say it's a five year term loan from Oxford Finance. It is interest only for the first three years, and then you begin to amortize the principal in year four and year five. It's a first security interest in substantially all of the assets of the company, which includes the IP. So there are certain restrictions that I think would be very customary and typical to venture debt. If there is any new debt that came in, it would clearly be subordinate to what we have with Oxford. We are certainly free to pursue an opportunity for nolasiban in China that we have talked about extensively. Ernest mentioned it earlier on the call, where we're really looking to find that partner who can help us from a development, regulatory and commercial standpoint in China with Nolasiban. So we have the opportunity to continue to work on that, which is a goal for us for this year.

Mark Connolly -- Credit Suisse -- Analyst

Thank you.


Our next question comes from Kevin McPhee [Phonetic] with RBC Capital Markets.

Ernest Loumaye -- Co-Founder and Chief Executive Officer

Yeah, OK. Go ahead.

Justin Burns -- RBC Capital Markets -- Analyst

This is Justin on for Kevin, thanks for taking the questions. Just wondering if you can provide an update on sort of the remaining moving parts that you're discussing with the FDA, regarding the updated IND for Nolasiban in the United States. Sort of what talking points you fired [Phonetic] out with them already and plan on incorporating the IND and then if you're able to discuss it, any of the sort of remaining touch points that you need to go over with them? Thank you.

Ernest Loumaye -- Co-Founder and Chief Executive Officer

Yes. So as we said, we have been progressing on the many aspects of the critical design and have reached agreement on many of those aspects. There is a couple of aspects on the protocol design, which are still open. The FDA informed us that they are discussing that internally. The plan is to submit the IND this quarter, as we mentioned earlier, with the justification for why this couple of residual discussion point should be solved in the way we are considering. We are thinking it should be -- it's about time of randomization and [Technical Issues]. With this justification and the updated protocol, we will file the IND, which would allow us then to receive the feedback of the FDA on the protocol comment, and in parallel, to start preparations for initiating the study.

So we don't see for the moment, any reason for not moving forward, continuing to dialog with FDA and supplying the rationale for why the protocol is finalized, as it is today.

Justin Burns -- RBC Capital Markets -- Analyst

Great. Thank you very much.


Our next question comes from Eric Joseph with J.P. Morgan. Your line is now open.

Turner -- J.P. Morgan -- Analyst

Hey, good morning, everyone. This is Turner [Phonetic] on for Eric. A question to follow up on PRIMROSE. We've seen from the recent competitor GnRH Phase 3 data, higher than expected or variable response rates in the placebo arm. I'd just be interested to get your take on that observation and what level of the placebo effect you anticipate in PRIMROSE? Thanks.

Ernest Loumaye -- Co-Founder and Chief Executive Officer

Obviously, the study is double blind, so we cannot talk about our placebo responder rate. My interpretation is that the difference in placebo responder rate, may be due to the severity of the condition at baseline. Indeed, you would remember, that the response rate is defined by having less than 18 milliliters blood loss in 28 days, as well as a reduction of 50% from baseline for individuals. So I can imagine that, if you have a less severe population, you may have a little bit higher chance. But to meet this criteria, just by chance.

Now, is that critical or not? I'm not sure. At the end of the day, you want to have a number of patient responding. So I think we should address your question when we have the data at fourth quarter of this year.

Turner -- J.P. Morgan -- Analyst

Great. Thank you.


Our next question comes from Ram Selvaraju with HC Wainwright. Your line is now open.

Ram Selvaraju -- HC Wainwright -- Analyst

Thanks very much for taking my questions. Firstly, on the clinical front, I was wondering whether you have more visibility at this juncture, regarding how long it's likely to take to discuss all of the remaining open items with the FDA and file the IMPLANT 3 clinical trial protocol, whether you now think that there is a higher likelihood that IMPLANT 3 would start before the end of this year, or early in 2020?

Also revisiting a question that was I think posed earlier. I wanted to clarify and drill down on this a little bit. With respect to linzagolix and the potential competitive efficacy profile, what has your market research started to indicate with respect to the possibility of one of the following two scenarios? Either A, linzagolix has the no add back therapy advantage, but similar comparable efficacy to Orilissa and Relugolix? Or B linzagolix appears to demonstrate some kind of efficacy superiority, even if only on a numerical basis, clearly not on a head to head basis, with respect to Relugolix and elagolix. And I just wanted to understand better, whether there is a picture resolving here, as to whether the advantage of not having to use add back therapy, would be sufficient to position linzagolix as a potentially best in class treatment, if the efficacy profile is similar to that which we have seen with relugolix and elagolix? Or if given the fact that elagolix is already on the market, given the fact that relugolix would probably reach the market ahead of linzagolix. If you need to demonstrate some kind of efficacy advantage in addition to the convenience of non add-back therapy?

Ernest Loumaye -- Co-Founder and Chief Executive Officer

So Ramesh, let me take the first would ask Wim to address the second one. The process is ongoing with the FDA. We are close enough to file an IND with the justification for the final protocol and to initiate the trial. And then, [Indecipherable] interaction, which may seem to open and become some aspect of review issue. But we don't believe that this will be any means, reason for putting the IND on hold or refusing to file the IND. So for us, we are very confident of that. So I think, yes, we are aiming, whether it's late, early this year -- late this year or early next year to start, I think with the Christmas period between the two and, you know, we may miss it by two weeks on ethics committee, because of the Christmas period. So we stick to starting the trial by the end of the year or early next year.

Regarding the other question for our linzagolix positioning, I would like now to ask Wim maybe to comment on the need to differentiate based on non add back or absolute superiority?

Wim Souverijns -- Chief Commercial Officer

Thanks, Ernest. Yes, Ram, we actually are in the process of kicking off the research that you were asking for. So we'll have actually market data on that later this year. But from the get-go, what I can say is that, there is a patient population in fibroids, that actually will not be suited for using add back therapy. So if we can demonstrate your first scenario, similar efficacy, but no need for add back on the 100 milligram, that would allow us to address the population that the other therapies cannot. These are patients with a high BMI, hypertension, cardiovascular risk, etcetera. And in fibroids, these are women that are a little older age. It's quite prevalent. So that segment of the market, with same efficacy as our competitors, we can really win there.

Now, if we obviously have an efficacy benefit on top of that, that will facilitate things even more and we'll have a broader expansion possible. But I do think that, simply having a effective drug with add back, would allow us to grab a significant part of the market. We will come back later this year with data on this from the US market, because what we anticipate is also that, there won't be a subset of patients, that even if they would be physiologically be able to take add back therapy, they wouldn't want to. So we want to assess what are the profiles of these women, what hopefully, we can also get assessment of the size of that opportunity. But we believe that [Indecipherable] of those women that from a therapeutic perspective, can't take add back therapy. There's also a group of women that will not want to take it. And again, there with similar efficacy, we would be the only player that can win in that segment. Does that answer your question?

Ram Selvaraju -- HC Wainwright -- Analyst

Yes. No, that's extremely helpful, and I think that's important to realize that kind of no matter what the timing of linzagolix introduction to the market is, or what potential lag there might be, there is a group of patients who are going to be available for you to take, no matter what happens, as long as you demonstrate the ability to use linzagolix without the need for add back therapy. Just two other quick things if I may; Eernest I was wondering if you could elaborate on what is going to underpin the go/no-go decision on OBE022? And then with respect to again, the debt, just a couple of clarificatory points. I wanted to understand better, whether your guidance for the projected operational runway with this additional financing, assumes drawing down all three tranches, or just the one you have already drawn down? And if this guidance also assumes that the go/no-go decision would be a go on OBE022? Thank you.

Ernest Loumaye -- Co-Founder and Chief Executive Officer

So Ram, as you remember, we are going to introduce first 60 patient, 30 placebo, 30 half-life. So we have no formal fertility analyses on that. I think is premature and can kill the product for no reason. So that would be, I would see, a qualitative assessment from the clinical standpoint into any trend in term of efficacy and obviously, good safety. So we would be, I would say, liberal to continue. I've seen in my life, interim analyses which were negative and then continuing the trial was positive. So I think we have to be careful here. But it's important that we evolute [Phonetic], to confirm that we can continue with this interim efficacy, and some good safety. So that's the context for taking the analysis of diversification.

In terms of cash runway, I am going to ask Tim. But I would like to make it very clear, is that, the cash runway, which is $75 million last quarter of 2020, include budgeting of continuing prolonged full blow IMPLANT 3 continuation start and continuation, and start off putting in place, the commercial organization for Nolasiban in Europe. So there is nothing which is subtracted from that cash runway. So it's a scenario with full blown development of the three products, including initiation of the commercialization. Now Tim, do you want to add something on that?

Tim Adams -- Chief Financial Officer

Yes. Just Ram, to your first question, I think Ernest may have just said it. But the cash runway into Q4 of 2020, yes, includes the utilization of all three tranches. It's the $75 million. We do have a $10 million requirement of cash on the balance sheet. So it's a net $65 million that would be fully available upon reaching the milestones and those additional tranches and 022 is included into next year as well.

Ram Selvaraju -- HC Wainwright -- Analyst

Okay. And then I didn't see this specifically in the debt covenants, but I wanted to know if you could clarify these two items. Firstly, what do the debt covenants say about possible change of control? Is there some kind of blocking privilege that the lender has? If so, what is it? Under what circumstances? And then also, if you could clarify whether there's any unusual end of term structure specified in the covenants, like a balloon payment or anything like that? Thank you.

Tim Adams -- Chief Financial Officer

For a change of control, Ram, we have the ability to work a transaction on the front end. But before we could consummate the transaction, the lender wants to have a say so, to ensure that they get repaid. Now that's obviously going to happen, because they have applied to the IP and that's what the buyer ultimately is going to want. So I think we have a lot of room to run the business from an M&A perspective, that would be appropriate for shareholders.

In terms of any final payments -- so we have the ability to prepay at any time. There are additional fees, if you will, for prepaying that would hit, and that's effectively -- there is a final payment. If you let it all run the term in five years, there is a final payment. I believe it's 6%, 7% approximately.

Ram Selvaraju -- HC Wainwright -- Analyst

Thanks very much.


Our next question comes from Do Kim with BMO Capital Markets. Your line is now open.

James -- BMO Capital Markets  -- Analyst

Hi. This is James [Indecipherable] dialing in for Do. Thank you for taking our questions and congrats on the progress. Quick question on nolasiban. As you're approaching commercialization, how have the talks with payers in Europe been? And are you still using PGDs as a comparable price point, or are you approaching pricing from the standpoint of cost savings on healthcare system? And a quick follow up, are you approaching it the same way for the US market? Thank you.

Ernest Loumaye -- Co-Founder and Chief Executive Officer


Wim Souverijns -- Chief Commercial Officer

Hi there, thanks for the question. So we have indeed spoken with most of the European markets in the last six months, and we have gotten very positive feedbacks. There is a great recognition of the value that nolasiban represents. As you've seen from our KOL event, there are different dimensions to it. First one is increasing productivity. The efficacy, which is higher. Second point, is the impact on the ancillary treatments for patients that go through failure. And the third one is, the impact on the multiple pregnancies. The consistent feedback we're getting from payers is that we should be really focusing on the core, which is our productivity impact because that's sufficient to really justify the pricing assumptions that we are at the moment, handling. It's -- we're very confident in our ability to do that and asking a question on whether we use PGD versus cost savings as a proxy or as a method to calculate. As you probably know, in Europe, we really have to go through some sort of value for money over health economic assessment. In some countries, that's more formal than others. But in general, that's the practice. So benchmarking to PGD is not sufficient. It can be an input, but it's definitely not what's going to give you reimbursement. So what we apply here is a cost effectiveness assessment. We have at the moment, a broad version of that [Indecipherable] and that in the next month to really go into the details for very formal applications. That's the approach that we use.

For the US we'll do something similar, in that we will use value for money assessments, a nicer approach I would say. It's true that in the US, sometimes benchmarks are more readily accepted as a reference. At least they set the stage from a pricing perspective. I have to admit that we have had very limited discussions yet for US. So we're gonna be expanding with that research, probably beginning of next year, because we also have a bit of time, given the start of IMPLANT 3 for US. But the first responses that we're getting are, similarly positive. I think there is a huge recognition in the payer community, that they've rarely seen a drug that has such a dramatic impact on efficacy, and efficacy here is translated in economic benefit, because of the cost of IVF, the impact on patients, impact on the center. So we feel very confident that our value proposition will ring true in our pricing, that we will ultimately be able to obtain in different markets.

James -- BMO Capital Markets  -- Analyst

Thank you very much.


Our next question comes from of Ruben Boyajian with SEW [Phonetic]. Your line is now open.

Ruben Boyajian -- SEW -- Analyst

Hello. I have some follow up questions about the financing. I understand that beyond Q4 2020, you need some more finances. Can you indicate how large that's going to be? You said you were seeking for opportunities in China for nolasiban, does that mean licensing nolasiban out for the Chinese market? And is this a priority or do you also consider issuing more stock?

Tim Adams -- Chief Financial Officer

Yeah, this is Tim. So we have said it's a corporate objective this year, to find the right partner for nolasiban in China. As you heard Ernest mention earlier, China is one of the largest IVF markets in the world. There seems to be a very strong demand for IVF, and with something -- that the improvements that nolasiban can bring. So our team has been working on finding the right partner. They need regulatory development, commercial expertise, and we helped -- we have a deal that we can announce by the end of the year.

In terms of, future financing plans, our objective with this Oxford loan was to extend the runway, approximately a year beyond the data readouts that are happening in Q4 of this year. So that's what we've been able to accomplish. We have not said and we don't comment publicly beyond that in terms of what future plans are.

Ruben Boyajian -- SEW -- Analyst

Okay. Thank you.


I'm showing no further questions in queue at this time. I'd like to turn the call back to Ernest Loumaye for closing remarks.

Ernest Loumaye -- Co-Founder and Chief Executive Officer

Yes, so I want to thank everyone for taking the time to participate in this call. We clearly appreciate the opportunity to share the progress we have made, and future for our innovative pipeline, targeting the important area of women's health and fertility. So I wish you all a very good day. Thank you very much. Bye-bye.


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

Duration: 66 minutes

Call participants:

Mario Corso -- Senior Director of Investor Relations

Ernest Loumaye -- Co-Founder and Chief Executive Officer

Elizabeth Garner -- Chief Medical Officer

Wim Souverijns -- Chief Commercial Officer

Tim Adams -- Chief Financial Officer

Ami Fadia -- Leerink -- Analyst

Mark Connolly -- Credit Suisse -- Analyst

Justin Burns -- RBC Capital Markets -- Analyst

Turner -- J.P. Morgan -- Analyst

James -- BMO Capital Markets  -- Analyst

Ram Selvaraju -- HC Wainwright -- Analyst

Ruben Boyajian -- SEW -- Analyst

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