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Apricus Biosciences Update Call (Transcript) Aug 12 2013, 11:01 | about: APRI if (getURLParam('source') == 'yahoo'){ $('yahoo_finance_link_container').innerHTML = '
'; } Executives
Edward M. Cox - Vice President of Corporate Development
Richard W. Pascoe - Chief Executive Officer and Director
Steven R. Martin - Chief Financial Officer, Principal Accounting Officer, Senior Vice President and Treasurer
Analysts
William Tanner - Lazard Capital Markets LLC, Research Division
Scott R. Henry - Roth Capital Partners, LLC, Research Division
Apricus Biosciences (APRI) Q2 2013 Earnings Call August 12, 2013 9:00 AM ET
Operator
Greetings, and welcome to the Apricus Biosciences Corporate Update and Highlights Conference Call. [Operator Instructions] As a reminder, this conference is being recorded.
It is now my pleasure to introduce your host, Edward Cox, Vice President of Business Development. Thank you. Mr. Cox, you may begin.
Edward M. Cox
Good morning, and thank you for joining us on the call today. I'm Ed Cox, Vice President of Business Development here at Apricus Bio. With me from Apricus is our Chief Executive Officer, Rich Pascoe; along with Steve Martin, our Chief Financial Officer. During today's call, we will review recent corporate events and recap the company's upcoming milestones, after which, we will open the call for questions.
Let me remind everyone, during today's conference call, the management team will make 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 Securities and Exchange Commission for additional discussions on factors affecting our business.
With that, I will turn the call over to Rich. Rich?
Richard W. Pascoe
Thank you, Ed. And good morning, everyone, and thank you for joining us today.
At the beginning of this year, we announced a more focused corporate strategy centered on the creation of long-term shareholder value through the continued development, regulatory approval and commercialization through our strategic partnerships of our lead products Vitaros and Femprox. During the second quarter, we made significant strides towards our objectives.
Our main accomplishments during the second quarter were as follows. In June of this year, we gained regulatory approval for Vitaros in Europe. And we continue to work independently, as well as with our commercialization partners, on obtaining national phase approvals for Vitaros in each of the included individual territories across Europe. Last week, we received national phase approvals in the United Kingdom and Sweden, which is exciting progress for our United Kingdom licensing partner, Takeda. We are in licensing discussions with multiple potential partners for Vitaros in the remaining un-partnered territories throughout the world.
Second, we continued to advance the Femprox development program and are actively preparing for an end-of-phase 2 meeting with the Food and Drug Administration in late August. Following receipt of the official FDA [indiscernible], we will be able to provide more clarity on the Femprox regulatory pathway here in the United States. And third, we've completed a $17.1 million public offering of our common stock and warrants, the net proceeds of which we intend to use for our various development, approval and commercialization efforts related to Vitaros and Femprox.
I would now like to cover each of these items in more detail, starting with Vitaros. As you know, Vitaros is our lead product candidate for the treatment of erectile dysfunction, which utilizes alprostadil and our proprietary permeation enhancer DDAIP in a novel, topically applied formulation. Vitaros is approved as a first-line erectile dysfunction therapy in Canada. And in early June, we received news that the marketing application for Vitaros was approved through the European Decentralized Procedure, or DCP. Under the DCP, we filed the application for marketing approval designating the Netherlands as the Reference Member State or RMS on behalf of 9 other European Concerned Member States or CMS participating in the procedure. The CMS states include France, Germany, Italy, United Kingdom, Ireland, Spain, Sweden, Belgium and Luxembourg. As I mentioned, we continue to work independently as well as with our commercialization partners on the next steps, which is to obtain national phase approvals in each of the included territories listed above. Last week, we received a national phase approval for Vitaros in the United Kingdom and Sweden. And while we can provide no assurances on the exact timing of subsequent national phase approvals, we continue to believe that we and our existing commercialization partners remain on track to obtain national phase approvals for Vitaros throughout Europe, beginning in the third quarter of this year and continuing through the first quarter of next year.
Once these national phase approvals are secured on a country-by-country basis, marketing of Vitaros can then be initiated in each country by our commercialization partners. Once launched, Vitaros will become the first new and novel erectile dysfunction product in nearly a decade. And similar to Viagra, Cialis and Levitra, we believe it is well positioned for commercial success due, in large part, to a unique product profile that addresses a large number of patients who cannot or do not respond well to these existing therapies, or who are untreated or under-treated or who are intolerant to the systematic effects of PDE5 inhibitors such as Viagra. In Europe alone, the existing erectile dysfunction products generated over $1 billion in sales in 2012. And Apricus Bio believes that a significant portion of the market remains untreated or under-treated, which represents a substantial commercial opportunity for Vitaros.
We currently have Vitaros partnerships established in key markets including Canada, the United Kingdom, Germany and Italy. Moreover, interest in Vitaros remains strong in many of the unlicensed territories. Concurrent with the European approval of Vitaros in June of this year, we launched a comprehensive partnering process with the goal of licensing Vitaros in the remaining un-partnered territories in Europe, Latin America and North Africa. Our key partnering objectives for Vitaros are to maximize the total deal value for the asset; expand existing Vitaros partnerships wherever possible; and select partners who have a strong clinical, regulatory and commercial presence in their respective territory or territories. We are reviewing bids recently received from multiple interested parties for these available territories and we expect to complete our partnering process for Vitaros in the fourth quarter of this year.
Now I'd like to turn our attention to our other value-creating opportunity, Femprox. Femprox is our topical combination of alprostadil and DDAIP cream for the treatment of female sexual interest/arousal disorder, or FSIAD. The change in the target indication to FSIAD from female sexual arousal disorder, or FSAD, is a result of the recent update of the diagnostic and statistical manual of mental disorders, or DSM-V for short, which now includes the patient's interest or desire in sexual activities, as well as their physical arousal. There are currently no approved drugs available to treat this condition, and we are committed to the development and approval of Femprox to provide women with an option for this unmet medical need. To date, we have completed 7 clinical trials with Femprox, including a 100-patient Phase II study and a 400-patient proof-of-concept study. And 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 for the approval of FSIAD, as there are currently no current products approved for this condition and where estimates of the market size for the condition are on par with that found in the erectile dysfunction market.
Femprox is unique among its competitors in that it has a direct and localized mechanism of action and the limitation for other company's products in this space have been largely related to the systemic presence of drug amongst always either a hormone-based or SSRI or a very high placebo response rate. We believe that Femprox's distinct characteristics, including its topical delivery and unique mechanism of action, separate it from these other development candidates on many levels.
An end-of-phase 2 meeting with the U.S. Food and Drug Administration, or FDA, is currently scheduled for late August of this year. Leading female sexual medicine experts will join the Apricus clinical, regulatory and CMC team at this meeting in an effort to gain further clarity regarding the Femprox regulatory pathway in the U.S. to include discussing such items as the key patient population, primary and key secondary efficacy endpoints, study design, dose selection and safety monitoring requirements. Following receipt of the official FDA meeting minutes, we will complete the Femprox development plan, review that plan with our scientific advisers and then update our shareholders on that program, likely in the fourth quarter of this year.
Now as to the streamlining process we undertook earlier this year, we continued to make meaningful progress during the quarter. In March, we announced the tale -- sale of Totect to Biocodex. Under the terms of this arrangement, we received an upfront payment at closing and are eligible to receive royalties on net sales of Totect during -- or through 2016. In addition, we have very recently discontinued and/or divested our interest in our remaining non-core assets, to include Granisol and BQ Kits Incorporated. With the completion of the divestiture of our non-core commercial assets, Apricus has officially shed the last remnants of its commercial strategy and is now fully positioned for future growth through the advancement of our core assets, Vitaros and Femprox.
Finally, I'd like to make a few remarks about our recent financing. In May of this year, we completed a public offering of common stock and warrants for gross proceeds of $17.1 million. With this additional funding and a focused strategy that we have articulated, we are confident that we will continue to have the financial resources to carry out our upcoming development, approval and partnering efforts related to Vitaros and Femprox.
I would now like to turn the call over to Steve, our Chief Financial Officer, to provide a status report on the second quarter financial results. Steve?
Steven R. Martin
Thank you, Rich.
Late last week, we announced that we would file our second quarter financial results by Wednesday, August 14, and we're on schedule to achieve that timeline. In the announcement, we stated that our auditors indicated that they believe we may have a material weakness in our system of internal controls over financial reporting. And accordingly, the company is reassessing the adequacy of its internal controls over financial reporting related to certain technical accounting matters for those same periods, and those conclusions will be disclosed in the Form 10-Q when filed this week. It is important to note, the company believes that the audited consolidated financial statements included in the 2012 Form 10-K and the unaudited condensed consolidated financial statements included in the Form 10-Q for the quarter ended March 31, 2013, do not contain any inaccuracies and can be relied upon. The company takes responsibility for the accuracy of its reported financial results and for the effectiveness of its internal controls very seriously. We expect to complete our internal controls assessment this week related to the June 30, 2013, quarter, collaborating with other auditors on the outcome and any necessary disclosure related to internal controls, and deliver complete and accurate financial results in our upcoming 10-Q.
I can report that the financial position of Apricus remains strong. And our cash was approximately $24.8 million as of June 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 into late 2014. We expect our cash inflows during 2013 will be from licensing revenues received from commercial partners for our late-stage product candidates. We expect our most significant expenditures in 2013 will include development expenditures, including continued regulatory and manufacturing activities related to Vitaros, and costs associated with the clinical development of Femprox.
With that, I'll turn the call back over to Rich. Rich?
Richard W. Pascoe
Thank you, Steve.
I want to close by saying that Apricus is well positioned to fulfill its vision of 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. While we have already achieved several key corporate objectives this year, we have a number of important milestones coming up through the remainder of the year and beyond that we believe will help us more fully realize that vision as well as advance patient care and, importantly, to build long-term value for the benefit of our shareholders. These include additional national phase approvals in Europe for Vitaros; commercial launch of Vitaros following those approvals by our strategic partners Takeda, Sandoz and Bracco; signing of additional partnerships in major global markets; providing more clarity on the revelatory pathway and our development plans for Femprox in the U.S.; and growing the Apricus team's support of our key Vitaros and Femprox initiatives.
With that, we will now open the call for questions. Operator?
Question-and-Answer Session
Operator
[Operator Instructions] Our first question today is coming from Bill Tanner from Lazard Capital Markets.
William Tanner - Lazard Capital Markets LLC, Research Division
Rich, I don't know if you want to comment on what the deal structure might look like for some of the partnerships you might enter into, but I guess I'm really interested is, as we look at the unencumbered or the countries that presumably Vitaros will be approved in and have not yet been partnered, how you see those playing out just with respect to whether you're going to engage multiple partners. And then, I guess also, just to your viewpoint on, at some point in time in the future, is it possible that you might see some consolidation of the partnerships given the fact that you've got, at least now, about -- several partners, and presumably more to come. And I have a couple of follow-ups.
Richard W. Pascoe
Yes, thanks, Bill, appreciate the question. Clearly, we are blessed to have several things related to Vitaros occurring here in the second quarter, with the approval across Europe with these first of what we believe to be many national phase approvals. And we're also excited about our existing commercial partners: Takeda, Sandoz and Bracco are taking the lead in that respect. From a deal structure perspective, I think what we're looking for here and what we're focused on right now is our deals that clearly provide us value for an approved product in the territory. And as I said in my prepared remarks, we are placing a priority on expanding existing relationships, which I think gets to the second part of your question. Our expectations are and the guidance we've provided and the bids we've received relative to this exercise have all pointed potential partners in the direction of a market deal in terms of upfront milestones and royalties. And as I said before, wherever possible, we would like to expand the relationship we have with an existing partner into other parts of Europe or the emerging markets. And so we'll have the opportunity to bring more clarity to this topic to the table in the fourth quarter as we work through the process. The interest in Vitaros, from a partner perspective, not just in Europe but outside of Europe and parts of Latin America and North Africa, for example, has been extraordinarily high. And so we're very pleased with the response that we've received from partners that are interested, both current and potential new partners.
William Tanner - Lazard Capital Markets LLC, Research Division
And I appreciate that you may be limited in what you can say or what you've been told, but any comment that you could make on Vitaros in Canada?
Richard W. Pascoe
Yes, well, we continue to support the Canadian launch preparations with Abbott. Abbott continues to work through the issue that we described in full detail on the last call, and we'll update everyone if we have news to share. But Abbott remains committed to launching the cold chain product. As you know, the shelf life issue there related to the specifications for the product in Canada have been the key sticking point, and Abbott continues to work towards resolution of that.
William Tanner - Lazard Capital Markets LLC, Research Division
And then, I guess, just a final one. As with, obviously, rights partnered to Warner, anything to report there, any thoughts on the ones that the acquisition, I guess, has consummated, what might -- what opportunities it might present for you guys?
Richard W. Pascoe
Yes. We're anxiously awaiting the outcome of the Warner Chilcott-Actavis merger, simply because we would like to understand more fully what Actavis' intentions are as it relates to the continued development of Vitaros. We know that Warner has remained active with the product, including purchasing clinical trial material from us last year. But at the same time, given the status of that merger and a -- we would anticipate a closing of that deal later this year. It's difficult for them to say much about their portfolio rationalization at this time to us. Having said that, if the opportunity were to present itself for us to repatriate those rights from, in this case, Actavis, we would be very interested in that because we feel very strongly that Vitaros is a product that should be introduced in the United States, and we'd like to see that happen.
Operator
[Operator Instructions] Our next question is coming from Scott Henry from Roth Capital Partners.
Scott R. Henry - Roth Capital Partners, LLC, Research Division
You've got a lot done this quarter. For starters, the U.K. and Sweden approvals, when do you expect a product launch could happen? I don't know if -- did you have to go through pricing discussions there? And can you quantify the magnitude of those markets?
Richard W. Pascoe
Thanks, Scott. So the U.K. process, of course, has been guided and directed by our partner, Takeda. And the Swedish process is one that we're primarily responsible for through our own efforts, and we'll continue to see that play out here in the third and fourth quarter with the remaining territories. Obviously, United Kingdom represents a much larger market opportunity relative to Sweden and is potentially in -- at least in Western Europe, a -- I would say, a close second to France in terms of its overall value and market opportunity. From a launch timing perspective, we're not commenting specifically on partners -- our partner's timing, but we do believe that Takeda is poised with this particular national phase approval and the preparations that they've laid the groundwork for, to date, to be in a position to be very aggressive on their launch timing. And so we will report out at the appropriate time more details on launch preparations and timing, but we'll obviously be taking that queue and that information with their consent from Takeda.
Scott R. Henry - Roth Capital Partners, LLC, Research Division
Okay. And could you just walk through, I know you've given a lot of this information, in Europe, what countries are partnered and which countries are not partnered?
Richard W. Pascoe
So the countries that are currently partnered are, the United Kingdom is partnered with Takeda, U.K. specifically. Sandoz has rights in Germany and Bracco has the rights to the product in Italy. So that leaves the balance of Western Europe to include the Nordics; Benelux, for example; all of the emerging markets, including Central and Eastern Europe, Russia, North Africa as well as Latin America and Asia Pacific. And the process that we have been working through over the last couple of months is focused on licensing out the remaining territories in Europe to include Eastern Europe, Russia and the like, as well as focusing on North Africa and parts of Latin America. And we've had interest of -- from multiple parties across all of those territories.
Scott R. Henry - Roth Capital Partners, LLC, Research Division
Okay. Now -- and is your goal to partner France now as well...
Richard W. Pascoe
Yes.
Scott R. Henry - Roth Capital Partners, LLC, Research Division
Is that probably the largest European country left not partnered?
Richard W. Pascoe
That is correct. France, Spain are the -- probably the 2 of the most value, combined, when you just look at the patient population, France of course being probably the leader across the board of all erectile dysfunction products in Europe.
Scott R. Henry - Roth Capital Partners, LLC, Research Division
Okay. And then final question, on Femprox. If I heard correct, and maybe I didn't, but it sounds like you've changed the indication from FSD to FSIAD. If that's the case, how should I think about that any differently, if at all?
Richard W. Pascoe
Not at all. This is a result of the DSM-IV being updated into currently the DSM-V, which occurred in May of this year, so since our last conference call. And in an effort to try to make it less challenging for physicians to diagnose women with the condition, the arousal and the interest disorder have been combined now into a single diagnosis, and thus the change. From a clinical development perspective, from an opportunity perspective, and clearly we'll be able to get in front of the FDA here shortly and ask the appropriate questions related to this, we see no change in our strategy or plans for developing Femprox. We think, in fact, this change will potentially make it easier, simpler for us from a recruitment and from a -- attracting patients into the trials that we would run for the product. So it's a nomenclature issue within the DSM-V or the change from IV to V. And as a result, we're adjusting our nomenclature from an indication perspective accordingly.
Operator
If there are no other questions at this time, I'd like to turn the floor back over to management for any further or closing comment.
Richard W. Pascoe
Thank you, operator. And I'd like to thank the entire team here for their ongoing efforts in successfully executing on our strategic focus. We are dedicated to making Apricus Bio a leader in the male and female sexual health marketplace. And I want to thank you all in the call for joining us today as well. And if you have any questions, please do not hesitate to contact the company directly.
Again, thank you today for your time.
Operator
Thank you. That does conclude today's teleconference. You may disconnect your lines at this time. And have a wonderful day. We thank you for your participation today.
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