Seelos Therapeutics, Inc.

Seelos Therapeutics, Inc.

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Biotechnology

Seelos Therapeutics, Inc. (SEEL) Q3 2013 Earnings Call Transcript

Published at 2013-11-13 13:40:07
Executives
Lourdes Catala Richard W. Pascoe - Chief Executive Officer and Director Mehdi El Glaoui Steven R. Martin - Chief Financial Officer, Principal Accounting Officer, Senior Vice President and Treasurer
Analysts
Irina Rivkind - Cantor Fitzgerald & Co., Research Division Kaey T. Nakae - Ascendiant Capital Markets LLC, Research Division
Operator
Greetings, and welcome to the Apricus Biosciences' Third Quarter 2013 Earnings Teleconference and Webcast. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Lourdes Catala, VP with Argot Partners. Please go ahead.
Lourdes Catala
Good morning, and thank you for joining us today. I'm Lourdes Catala, Vice President with Argot Partners, supporting Apricus. With me from Apricus is our Chief Executive Officer, Rich Pascoe; Steve Martin, our Chief Financial Officer; and Mehdi El Glaoui, Founder of Laboratoires Majorelle. During today's call, we will review recent corporate events and recap the company's upcoming milestones, after which, we will open the call up for questions. Let me remind everyone that during today's conference call, the management team will be making forward-looking statements regarding future events or future financial performance of the company. Please keep in mind that such statements are predictions based on current expectations and actual results could differ materially. You should refer to our most recent filings with the United States Securities and Exchange Commission for additional discussions on factors affecting our business. With that, I will turn the call over to Rich Pascoe. Rich? Richard W. Pascoe: Thank you, Lourdes. Good morning, and thank you all for joining us today on the call. Throughout 2013, we have been focused on the execution of 6 strategic goals. These include obtaining full regulatory approval for Vitaros, our novel on-demand topical treatment for erectile dysfunction across Europe; secondly, securing commercialization partners for Vitaros in the unpartnered territories in Europe; supporting our commercial partners' efforts to launch Vitaros in their respective territories; strengthening our balance sheet; obtaining regulatory guidance from U.S. FDA for Femprox, our lead product candidate, which is for the treatment of female sexual interest and arousal disorder or FSIAD; and finally, divesting all of our nonstrategic assets. I'm pleased to report that we have made substantial progress on all fronts, which I will review with you in more detail to include an update for both Vitaros and Femprox. Steve will also provide you with an overview of our financials. But before we get into the Vitaros and Femprox update, I want to begin by discussing our Vitaros partnership with Laboratoires Majorelle in France, Monaco and Africa, which we announced this morning in our press release. As previously reported, we have been actively engaged in Vitaros partnering discussions with the goal of licensing commercialization rights to Vitaros in the remaining unpartnered territories in Europe, Latin America and Africa. Our key partnering objectives are to maximize the total deal value for Vitaros, expand existing partnerships wherever possible and secure partners who have a strong clinical, regulatory and commercial presence in their respective territories. This morning, we announced an exclusive license agreement with Majorelle for the commercialization of Vitaros in France, Monaco and certain African countries. Under the terms of the agreement, Apricus is eligible to receive up to $4 million from Majorelle in upfront and regulatory payments. Apricus is also eligible to receive approximately $21 million in milestone payments based on future sales, plus double-digit tiered royalties based on Majorelle's net sales of the product in the territory. In exchange, Majorelle will have the exclusive right to commercialize Vitaros in the territory. In addition, Majorelle has agreed to minimal marketing commitments for Vitaros, including an expansion of its existing sales force in France. We are very excited to enter into this relationship with Majorelle for Vitaros, and as such I would like to invite the Founder of Majorelle, Mehdi El Glaoui to say a few words. Mehdi is a very accomplished executive. So before I turn it over to him, I would like to provide you with his background. In addition to his role as Founder and Chairman of Majorelle, Mehdi is currently a member of the Board of Directors of the Louis Dreyfus Holdings and Louis Dreyfus Commodities, the latter where he served as Chairman for several years. Louis Dreyfus Commodities is a leading, privately held global merchandiser of commodities and agricultural products, which generated over $57 billion in revenue last year. Mehdi has also had a long and successful career as a pharmaceutical executive to include serving as the CEO and President of Wyeth Letterly France from several years prior to founding Majorelle. With that brief introduction, I would like to turn it over to Mehdi. Mehdi?
Mehdi El Glaoui
Thank you, Rich. On behalf of Laboratoires Majorelle, I want to say that we are delighted to partner with Apricus in France, Monaco and France speaking Africa to commercialize Vitaros. Majorelle is a leading specialty pharmaceutical company with a strong presence in France, one of the largest ED markets in Europe. Majorelle has an experienced sales team focused in male and female urology and reproductive health. In addition, we have a highly effective clinical, regulatory and marketing team which I believe is well-equipped to bring the unique benefits of Vitaros to patients and healthcare providers in these key markets. The management team at Majorelle has extensive experience in building blockbuster brands in France. We have accomplished this by setting clear objectives, developing smart strategies, fostering extreme motivation and flawless execution. Majorelle is committed to following these paths again in a network to make Vitaros its first blockbuster product. Vitaros is our #1 priority and I can ensure you that France will be amongst the most productive Vitaros market in Europe. Following receipt of the national phase approval in France, we look forward to launching and generating meaningful sales with the first and only topical on-demand ED treatment. Furthermore, we are committed to growing our organization to meet the needs of Vitaros and as such, we will expand the size of our sales force in France in order to maximize the Vitaros opportunity for our mutual benefit. Rich? Richard W. Pascoe: Thank you, Mehdi, and thank you for joining us here this morning on the call. In addition to Majorelle, we currently have strong Vitaros commercialization partnerships already established in a number of key markets, including with Abbott Canada where Vitaros is approved as a first line ED therapy; with Takeda in the United Kingdom; with Sandoz in Germany; and with Bracco in Italy. For the remaining unlicensed territories, partnering interest in Vitaros remains strong, and we are in late-stage discussions with a select group of potential partners. We have received multiple bids from other licensees, targets including our existing partners, and we continue to negotiate those terms that will be most favorable for Apricus in the long term. We expect to complete these negotiations and announce one or more new partnerships during the fourth quarter of this year. Looking ahead, we believe that our partners are currently on track for a European launch of Vitaros in 2014. As of today, Vitaros has received 5 national phase approvals in Europe, including Germany, Ireland, the Netherlands, Sweden and the United Kingdom. We continue to work independently, as well as with our commercialization partners to obtain country-by-country national phase approvals in the remaining CMS territories, which are France, Italy, Spain, Belgium and Luxembourg. Our regulatory efforts, along with actions taken by our existing European partners, remain on track to obtain these remaining approvals during the balance of the fourth quarter and into the first quarter of next year. Product launch initiatives and marketing planning have been initiated by each of our commercialization partners, depending upon the status of the national phase approval and the readiness of the individual partners to place commercial product orders for Vitaros. We have received commercial product orders from certain partners and we have begun the manufacturing activities in support of their commercial launch. We are currently projecting the first delivery from our contract manufacturer of Vitaros commercial product will take place in early 2014. As previously noted, Vitaros is approved in Canada and Apricus have a license to right to Abbott Canada for commercialization of the product in that territory. Abbott remains fully committed to the successful launch of the cold chain version of Vitaros in Canada in the shortest timeframe possible. Abbott is working with our contract manufacturers to optimize the product shelf life, which has driven specification -- which is driven by specifications that are applicable only to the product that will be sold in Canada prior to launching the product in that market. With respect to the timing of the launch of Vitaros in Canada, Abbott provided the following update to Apricus this week, which I will now share. And I quote, "Abbott Canada is working on optimizing the shelf life of Vitaros as a refrigerated medicine. The delay in launch is not related to the safety or efficacy of Vitaros as it has already received approval from Health Canada. Abbott is committed to launching Vitaros in Canada to better serve the needs of patients suffering from ED and in accordance with the commercial agreement between Abbott and Apricus. Apricus will continue to support Abbott as they work towards a successful launch of the product in Canada, and will update the market on their progress as circumstances dictate." Outside of the DCP European approval process, we are also working towards obtaining approval in Switzerland. For this territory, Swissmedic, the agency for therapeutic products in Switzerland, in August of 2013 recommended against approval for Vitaros based on certain quality-related issues. We now have submitted an appeal to Swissmedic to address those issues pertaining to the targeted shelf life of the product and as such, we look forward to keeping you posted on our progress there. Once commercially on the market, Vitaros will be the first new and novel erectile dysfunction product in nearly a decade. We believe it is well positioned for commercial success due in large part to its unique product profile that addresses a large number of patients who cannot or do not respond well to existing ED medications, such as Viagra, Cialis and Levitra; are untreated or under-treated; or are intolerant to the systemic effects of PDE-5's inhibitors, such as Viagra. In Europe alone, the existing ED products generated over $1 billion in sales in 2012, and we believe that a significant portion of the market remains untreated or under-treated, representing a substantial commercial opportunity for Vitaros. We also continue to make progress on a number of manufacturing and development initiatives, including our next-generation room temperature version of Vitaros. We believe the room temperature version which will not require refrigeration and is expected to have a 24-month shelf life or more will be a key driver of Vitaros market growth and expansion in the long term. In addition, we have also selected a new manufacturing partner that will serve as a second source of global supply for Vitaros. We currently project that this new Canadian-based manufacturing site will be fully operational by the second half of 2014 and will be ready to supply cold chain Vitaros to our existing commercialization partners, in addition to our current partner, Therapex. This site will also serve as the primary manufacturing site for our room temperature Vitaros commercial development program and eventual commercial scale-up program. I'd now like to provide an update on Femprox. Femprox is our topical alprostadil and DDAIP cream for the treatment of FSIAD. Femprox is unique among its competitors and that it has a direct and localized mechanism of action and is delivered topically. The limitation for other products in this space have been largely related to the systemic presence of drug, almost always either a hormone-based or SSRI or other -- or related to other high placebo response rates. To date, we have completed 7 clinical studies with Femprox, including a 100 patient Phase II study and a 400 patient proof-of-concept study. The data generated from these studies strongly suggest that Femprox has the potential to effectively treat a broad, untreated patient population. Moreover, we believe that Femprox could be the first and only on-demand treatment approved for FSIAD, an indication where estimates of the market size are on par with that found in the erectile dysfunction market. In late August of this year, we completed an End-of-Phase II meeting with the FDA to gain further clarity regarding the Femprox regulatory pathway in the U.S. In written guidance we received from the FDA following that meeting, a number of key elements were addressed. First, the agency concurred with the proposed indication and patient population of FSIAD, the indication we believe leads to the most optimal labeling for the product and exposes us to the greatest number of patients; two, the agency also agreed that we can pursue this indication in both pre-and post-menopausal women, but that efficacy in each of these groups must be demonstrated separately; three, regarding clinical endpoints, the FDA confirmed that our use of Satisfying Sexual Events or SSEs and the arousal domain of the female sexual function index or FSFI, is appropriate. The agency also guided that future studies of Femprox should incorporate endpoints, which will be used to validate these specific arousal domain of the FSFI instrument. Fourthly, they agreed with our proposed dosage levels; and finally the agency stated that no additional nonclinical studies would be required to support a Femprox NDA in the U.S. other than a reproductive and development assessment. We have now met with our Scientific Advisory Board and reviewed the FDA feedback and have developed a draft clinical development program for Femprox in the U.S. An important gating item to be able to finalize the U.S. development plan for Femprox is understanding the outcome of a pending FDA approval decision for a competitive female sexual dysfunction product. We, along with our scientific advisers, believe that shareholder interest will be best served by advancing Femprox in the U.S., only after this decision by the FDA, regarding this FSD product is known, which we expect to occur around year end. Only then will we have a complete picture of the regulatory landscape in the U.S. Given the recent approval of Vitaros in Europe, we believe there may be potentially a shorter path to approval in Europe. Both Vitaros and Femprox contain a unique concentration of the same active ingredient, alprostadil, as well as our novel proprietary permeation enhancer, DDAIP. The recent approval of Vitaros in Europe could allow for a streamlined path to approval in Europe for Femprox, and as such, in parallel with our work in the U.S., we are working to obtain regulatory guidance for Femprox in Europe. We have requested a meeting with the European regulatory authorities, expected to be held in the first quarter of 2014 to gain further clarity regarding the Femprox regulatory pathway there. At this time, we expect we will be in a position to disclose our development plans for Femprox in early 2014, following receipt of these 2 important pieces of regulatory feedback. In any event, we believe that shareholder interest is best served by advancing Femprox into the clinic with a development partner. And as such, we will initiate partnering discussions for Femprox following the completion of these key activities that I just outlined in 2014. With that, I'll turn the call over to Steve to provide a status report on the third quarter financials. Steve? Steven R. Martin: Thank you, Rich. We filed our third quarter 2013 financial results with the U.S. Securities and Exchange Commission on Tuesday, November 12. For this call, I can report that the financial position of Apricus remain strong. Our cash and cash equivalents totaled approximately $20.6 million as of September 30, 2013, as compared to $15.1 million as of December 31, 2012. Based upon our current business plan, we believe we have sufficient cash reserves to fund our ongoing operations through 2014. We expect our cash inflows during the remainder of 2013 will be from licensing revenue received from commercial partners for our Vitaros products. We expect our most significant expenditures will continue to be for the development expenditures, including continued regulatory and manufacturing activities related to Vitaros. The process of narrowing our core business focus to just Vitaros and Femprox has allowed us to reduce spending on G&A in a quarter-over-quarter basis. General and administrative expenses were $2.9 million for the 3 months ended September 30, 2013, as compared to $3.8 million for the 3-month period ended November 30, 2013, and also March 31, 2013. We will continue to direct our cash resources towards the critical, value-driving activities for the business. Also in the third quarter, we realized a noncash gain of $534,000 related to a contract settlement with TopoTarget A/S associated with the release of possible contingent consideration due to that company. With this transaction, our balance sheet is now better aligned with our operating strategy going forward. The company has realized significant cash proceeds related to the sale of non-core assets in 2013. Cash totaling $5.6 million has been generated in 2013 from the sale of the New Jersey real estate, non-core pharmaceutical products and the diagnostic products business. When combined with the May 2013 equity fundraising, the company has added over $22 million to its cash balance in 2013. With that, I'll turn the call back over to Rich. Richard W. Pascoe: Thank you, Steve. Apricus remains well-positioned to fulfill its vision to becoming a leader in the development and commercialization of innovative products that improve sexual health. We have made significant strides this year in executing on our strategy with a more streamlined business model, a more disciplined approach to execution and a singular focus on creating meaningful long-term shareholder value by advancing Vitaros and Femprox. Looking forward, our #1 priority is supporting the successful launch of Vitaros across Europe in 2014, followed by a sustained effort to drive long-term value for our shareholders with Vitaros throughout the world. We have a number of important milestones in the remainder of this year and beyond that, will help us to more fully realize our vision of advancing patient care and building long-term value for the benefit of our shareholders. These include national phase approvals for Vitaros in the final 5 European territories during the fourth quarter of this year, and into the first quarter of next year; first European delivery of Vitaros commercial product in early '14; the rollout of multiple commercial launches of Vitaros by our strategic partners, including Majorelle in 2014; signing of additional Vitaros partnerships in major global markets in the fourth quarter of this year; driving long-term value for Apricus and our partners through the introduction of the Vitaros room temperature device; completing a meeting with the European regulatory authorities for Femprox in the first quarter of next year; communicating our strategic plan for Femprox in the U.S. and Europe in 2014; and finally, continuing to strengthen our balance sheet through partnering Vitaros and reducing our G&A expenses wherever possible. I also want to reaffirm our commitment to shareholders that we will continue to act responsibly and openly on our communications. As such, we have updated our corporate website, www.apricusbio.com in an effort to provide shareholders and stakeholders with the latest information pertaining to our business. I invite you to visit our website for current information on our company. And with that, we will now open the call up for questions. Operator?
Operator
[Operator Instructions] And our first question comes from the line of Irina Rivkind with Cantor Fitzgerald. Irina Rivkind - Cantor Fitzgerald & Co., Research Division: I wanted to delve a little bit into the Femprox guidance. Just trying to understand why you think you have an easier pathway in Europe and what you can do faster there? Also, it doesn't sound like you need to do any sort of skin testing of the product in the U.S. for Femprox. So I was just wondering if you could confirm that and if that's the case, if maybe the agency would be more open with considering that same possibility for the male product. I'll stop there. Richard W. Pascoe: Yes, thanks, Irina, for the questions. Pertaining or related to the European approval process, given that Vitaros, and of course the ingredients alprostadil and DDAIP are approved for the male indication for erectile dysfunction, based on the regulatory advice that we've received from experts there, it is potentially possible that we could move forward in Europe on a more aggressive timeline, and we want to confirm that. We have, as I stated, requested meetings with the European authorities. We very recently got confirmation that those meetings had been accepted or granted and we're working through the scheduling process now to put those on the calendar in early '14, most likely in January. The biggest issue is related to Europe versus the U.S. is that because of the approval of Vitaros in Europe, many of the safety and clinical safety related questions that we will have to answer or address in the U.S. have already been answered in Europe. And so as a result, given the efficacy data we have already generated for the product, it is potentially possible for us to be able to go into the clinic with a clinical program, certainly, one which would include running a pivotal trial, but one which would essentially look solely at -- or primarily, I should say, at the efficacy question related to these endpoints of satisfying sexual events and the arousal domain of FSFI. The other key point here is that the European authorities have already approved one product for the treatment of FSD, that product, Intrinsa, was approved some time ago, and so we also have come to understand that the agency has had a -- the agencies in Europe have had more experience in this regard than the U.S. FDA has. And of course, we would very much like to understand with a full transparency what the outcome of the Flibanserin approval decision is. So as a result, we think it's imperative that we get advice from the European authorities to confirm our thoughts. We'll do that here in the short term and then we'll be able to synthesize that information along with understanding the outcome of Flibanserin approval decision into our strategy for Femprox more globally. Irina Rivkind - Cantor Fitzgerald & Co., Research Division: What about the read-throughs to the U.S. market? Richard W. Pascoe: I'm sorry, say that again? Irina Rivkind - Cantor Fitzgerald & Co., Research Division: I said the read-throughs to the U.S. market in terms of, it doesn't sound like the FDA asked you for some kind of skin sensitizing trial for Femprox in the U.S. I'm just wondering if they may be more amenable to allowing the Vitaros that's partnered with Actavis now to proceed forward, and if you've heard anything on that front? Richard W. Pascoe: We did not discuss Vitaros with the agency specifically when we met with them in August, as you can imagine. I think the issue you're referring to is that in the U.S. that Warner Chilcott has been now part of Actavis, has been pursuing a regulatory clinical development path with that product in the U.S. The agency essentially told us, in August, that they would be assessing clinical efficacy and safety in pivotal -- in 2 pivotal trials. So we were not required to conduct any additional nonclinical studies other than the reproductive assessment that I mentioned in my remarks. And as such, we will continue to work with the agency on Femprox and in parallel, we have a high degree of interest in moving or having Actavis move Vitaros forward into the clinic and hopefully onto the market in the U.S. as well. Irina Rivkind - Cantor Fitzgerald & Co., Research Division: And then, if I could just ask one more. From the agreement that you signed today and the $4 million in upfront payment in regulatory milestone, how much do you expect to take immediately versus how much is attached to regulatory approvals and is sort of staggered towards the back? Steven R. Martin: Irina, good question. This is Steve. So we've announced that we have $4 million in upfront and milestone payments and roughly $21 million in future sales milestone opportunities. And then we have royalties on top of that. So we've not, in the past, broken down the specific amounts that are going to be in the near-term quarter. Part of that is for competitive reasons. Certainly, we're in an auction process for various territories and various licenses still, and so we try to be appropriate with the contract terms until it's necessary to be disclosed. So certainly, part of what we call the upfront in the sales milestones will show up in the near-term quarters but that will have to be reported once it's announceable in our public disclosures.
Operator
[Operator Instructions] Our next question comes from the line of Kaey Nakae with Ascendiant Capital. Kaey T. Nakae - Ascendiant Capital Markets LLC, Research Division: Just to follow up on that last question. There will be some amount related to this partnership that is reported as revenue in Q4? Steven R. Martin: That's correct. We received money today. I can let you know that. So part of the money that we announced is part of the transaction that is associated with this fourth quarter. Kaey T. Nakae - Ascendiant Capital Markets LLC, Research Division: Okay. And to your other piece of guidance about announcing another partnership before the end of the year, is the expectation that, that other partnership will also contribute to Q4 revenue? Richard W. Pascoe: Kaey, this is Rich. That's correct. As Steve noted, we are in active negotiations with other parties for the remaining territories throughout Europe and other parts of the world, and it's our objective and we believe that we can accomplish that objective to sign those transactions and to have fresh capital roll into the company in the fourth quarter. Steven R. Martin: That would likely be in revenues as well. Kaey T. Nakae - Ascendiant Capital Markets LLC, Research Division: Okay. And switching to Abbott in Canada. If they are committed to the refrigerated product, is there a gating item that needs to be completed before they decide to move forward with the launch of product? So you talk about the issues with the volume of the product and the shelf life, but what is currently being done that could allow them to move forward? Richard W. Pascoe: They are committed, as you've noted and we made a statement in our remarks, to launching the refrigerated product in Canada as soon as possible once they achieve the requisite profile and the shelf life of the product. It is our understanding that they're working with the regulatory authorities in Canada to be able to accomplish that. And so beyond that, I can't really comment on their activities per our agreement. But -- and I certainly don't want to betray any confidentiality with them, but at the same time, I can assure the listeners and yourself that they are working very, very diligently to address this issue and they are very much committed to getting this product into the Canadian market as quickly as possible. Kaey T. Nakae - Ascendiant Capital Markets LLC, Research Division: In terms of timing then, given that you continue to work in the background on the room temperature product. Is this something that we should anticipate the launch of the refrigerated version to happen sometime in 2014? Richard W. Pascoe: Well, the refrigerated version, which is the current version approved both in Canada and in Europe will be launched in those respective territories by our partners. The room temperature version of the product, which we have made some significant progress on this quarter and will continue to do so, is targeted for a 2015 launch. Kaey T. Nakae - Ascendiant Capital Markets LLC, Research Division: Right, no, I'm talking specifically about the room temperature -- the refrigerated version of the product by Abbott in Canada. If they're not going to launch in 2014, why don't they just wait for the room temperature version? Richard W. Pascoe: Well, I didn't say that they're not going to launch in 2014. That's their goal to launch next year with a cold chain product. Kaey T. Nakae - Ascendiant Capital Markets LLC, Research Division: Okay. And then in terms of... Richard W. Pascoe: Maybe I can just make one more comment there. I want to make it clear to everyone on the call that our partners in Canada, Abbott, are committed to launching the cold chain product. They are not waiting for the room temperature product to become available in mid-2015. They are committed to making this work with the current configuration and we are confident in their abilities to make that happen. Kaey T. Nakae - Ascendiant Capital Markets LLC, Research Division: Okay. Related to Femprox and your upcoming discussions with authorities in the EU, who -- which group, specifically, are you expected to meet with? Richard W. Pascoe: We're not going to disclose the specifics on our regulatory interactions, but suffice it to say that we will certainly have to include, because of the Vitaros approval, the reference member state, the Netherlands in those discussions. But there are also other authorities that we are intending to meet with as well, so that we have a complete understanding of what is necessary to move Femprox into the clinic and see it successfully approved once we complete its clinical development. Kaey T. Nakae - Ascendiant Capital Markets LLC, Research Division: Okay. And then just finally, switching back to Vitaros and the remaining country approvals. If we were to think about maybe an order in which those might occur, is there some that are further along or closer to approval? Richard W. Pascoe: Yes. We believe that in the remaining territories, notably Italy, which is partnered with Bracco, France now partnered with Majorelle, and Spain, that those are -- as well as Belgium and Luxembourg are all moving. I'll make a note that now that we have our agreement with Majorelle in place and announced, the activities related to transferring those regulatory responsibilities over them -- over to them are already underway, and we believe that with their involvement, we'll be able to accelerate the approval process in France for the product. So I would expect that by the end of the year, we should have, if not all, certainly, 4 or 5 of those -- 4 of the 5 of those completed and with those national phase approvals in hand, our partners in those territories will be able to move forward.
Operator
And our next question comes from the line of Irina Rivkind with Cantor Fitzgerald. Irina Rivkind - Cantor Fitzgerald & Co., Research Division: I had a financial question. There is a liability on your balance sheet of approximately, I think, $2.8 million regarding some dispute in France. And also, there's another legal dispute that's going to trial this month regarding something else in France. And I think you mentioned that your potential liability is $5.5 million, but you don't expect to have to pay it. Can you comment on these 2 potential liabilities? Are they the same thing, 2 different things and maybe just help us understand them better? Steven R. Martin: Irina, that's a good question. So they are separate items. One, we have a $2.8 million deferred liability related to our de-consolidation of the French entity. So when we de-consolidated, we had more liabilities than assets on the books, and so we put that liability there until all of the possible contingent charges or claims are cleared in the French court. So that $2.8 million is not a cash obligation. We do not expect, but it is the kind of a net residual of what was de-consolidated from our financials in April. Secondly, we've also disclosed publicly, that there is a roughly EUR 4 million claim that came from the Works Council in the French courts, so we believe that it is without merit. We vigorously defended ourselves. We think it's appropriate that there's no charge recorded in the P&L for that. Of course, the 10-Q also discloses that there's a court date set and that's supposed to be in November, but we believe with the signing of Majorelle and their association in France, we have a chance to potentially continue discussions with those parties that are making claims against Apricus. Certainly extend and push out the date of any hearing in the French courts and hopefully, conclude that matter on a reasonable basis with respect to either Apricus or Majorelle or any other parties. So again, we don't expect significant, if any, financial liabilities associated with it and that's why we've said we intend to vigorously defend ourselves. We've not recorded a charge related to any claim related to France. Did that help? Irina Rivkind - Cantor Fitzgerald & Co., Research Division: Yes, that does. And then just a follow-up on Femprox. So in Europe, if you choose to go down the development pathway, are you going to wait for the room temperature product there? Or are you going to move forward with the cold chain? Just trying to understand that a little more. And also in the U.S., when you were told to do trials in pre- and post-menopausal women, should we sort of understand that to mean 2 Phase III trials in each population and this is why you think it might be so large that you need a development partner? Richard W. Pascoe: Yes. Regarding our room temperature configuration, we do have, as part of our development program, a Femprox version of the room temperature device, and if it's available in the same timeframe as when we might kick off a Phase III program or through a partner, I should say, kick off a Phase III program in any territory then we would certainly want to do that. Understanding that if we're ready to move and the room temperature device is not quite ready for that activity, we would move forward with the cold chain product. So I think that's still to be determined based on guidance and based on timing. But our intent would be to move into the market for Femprox with the room temperature configuration and we think we can do that either way, whether it's a cold chain or room temp device, into clinical trial or trials. Secondly, as it relates to the post- and pre-menopausal women, we were delighted to hear from the FDA that they are accepting of us being able to address both pre-and post-menopausal women in our clinical development program. As we stated, we would have to demonstrate safety and efficacy separately in each patient population. That could be done, as you suggest, Irina, in separate trials or it could be done in larger trials where you would analyze the efficacy in each respective population as part of a single pivotal or pair of pivotal trials. Either way, it certainly does introduce questions of trial size and expense and cost, all of which we are taking into account, but what I want to come back to is that we're committed to making what we believe to be the best decision for Femprox, the right strategy for a product that we think has value. And if that means that we pursue "Europe first strategy" with the product or we do more of a global partnering outreach for the product based on what we know in both Europe and the U.S. or we look to include or not certain patient populations, all of that will be taken under consideration once we have these pieces of the puzzle in place, meaning we have FDA advice in hand. It's very clear. It's very straightforward and I think it gives us a path forward to move with a partner. But we also want to understand what's possible in Europe, and we're going to do that here in the short term. And thirdly, I think given the regulatory uncertainty of Flibanserin, it is critical that we understand what the FDA's decision outcome is there because it will certainly weigh on our strategy and plans moving forward in the U.S. for Femprox.
Operator
And it seems we have no further questions at this time. I'd like to turn the floor back over for any closing comments. Richard W. Pascoe: Thank you, operator, and I'd like to thank the entire team here at Apricus for their ongoing efforts and successfully executing on our strategic goals this quarter. We are dedicated to making Apricus a leader in the male and female sexual health marketplace, and I also want to thank Mehdi and his team back in France and Majorelle for their commitment to making Vitaros a success in France, Monaco and Africa. I want to thank you all on the call for joining us today and as always, if you have any questions, please do not hesitate to contact the company directly. Again, thanks, everyone, today for your time.
Operator
This concludes today's teleconference. You may disconnect your lines at this time, and thank you for your participation.