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Apricus Biosciences (NASDAQ:APRI)

Q2 2014 Earnings Call

August 12, 2014 8:00 am ET

Executives

Angeli Kolhatkar -

Richard W. Pascoe - Chief Executive Officer and Director

Steven R. Martin - Chief Financial Officer, Principal Accounting Officer, Senior Vice President, Treasurer and Secretary

Analysts

Scott R. Henry - Roth Capital Partners, LLC, Research Division

Kaey T. Nakae - Ascendiant Capital Markets LLC, Research Division

Irina Rivkind - Cantor Fitzgerald & Co., Research Division

Operator

Greetings, and welcome to the Apricus Biosciences' Second Quarter 2014 Financial Results and Corporate Update Teleconference and Webcast. [Operator Instructions] As a reminder, this conference is being recorded.

It is now my pleasure to introduce your host, Angeli Kolhatkar. Thank you. You may begin.

Angeli Kolhatkar

Good morning, and thank you for joining us today. I'm Angeli Kolhatkar, Senior Vice President with Burns McClellan. With me today from Apricus is Chief Executive Officer, Rich Pascoe; and Chief Financial Officer, Steve Martin. During today's call, Rich will review the company's progress in the second quarter, as well as expected milestones for the rest of 2014 and beyond. Steve will then provide an overview of the financials, and we will then open the call for questions.

I'd like to remind everyone that certain of the information discussed on today's conference call is covered under the Safe Harbor provision of the Private Securities Litigation Reform Act, and that during today's conference call, management will be making certain forward-looking statements regarding future events or future financial performance of the company, including statements related -- relating to expectations around the timing for commercial launch of products, business development plans and objectives such as out-licensing and acquiring products and product candidates, capital raising and the development of the company's product pipeline with second-generation products and other product candidates. Such statements are predictions based on current expectations and actual results could differ materially. Please refer to our most recent filings with the United States Securities and Exchange Commission, including our annual report on Form 10-K, the quarterly report on Form 10-Q, that we filed yesterday, for additional discussions regarding these and other risk factors that may affect our business. These documents can be found on the company's website at www.apricusbio.com.

Apricus' earnings press release for the quarter ended June 30, 2014, crossed the wire earlier this morning and is also available at the company's website.

I will now turn the call over to Rich Pascoe. Rich?

Richard W. Pascoe

Thank you, Angeli, and good morning. And thank you, all, for joining us on the call today. We are thrilled that Vitaros, our first internally developed drug candidate using our proprietary technology, DDAIP, has been approved and is on the market in Europe. Our commercial partner, Takeda, launched Vitaros in the United Kingdom in June; and just a little over a week ago, Sandoz, our partner in Western Europe, launched in Sweden. Although it is still early in the launch, we are very pleased to share with you that Takeda has exceeded our initial expectations with their launch of Vitaros in the United Kingdom, as evidenced by the additional commercial orders that Takeda has placed with us for our product. Moreover, the feedback from patients and physicians has been positive, which we attribute to the excellent job that our colleagues at Takeda have done in preparing the market for Vitaros in the United Kingdom.

Regarding Sandoz, we are equally pleased with their thoughtful introduction of Vitaros in Sweden, and we look forward to additional launches in Europe by Sandoz and other approved license territories. Like Takeda, Sandoz has developed a comprehensive approach to marketing Vitaros, with an emphasis on the key attributes of the product, including its efficacy and safety profile, coupled with its rapid onset and convenience, relative to the existing products on the market. I invite you to view our latest corporate presentation on our website to view samples of Takeda's and Sandoz's product-related materials.

With the launch off to a great start in Europe, we continue to manufacture and ship commercial and sample batches of Vitaros to our commercial partners, including Takeda and Sandoz. Importantly, we continue to make good progress towards bringing on a second source of supply for Vitaros and our contract manufacturer group, PARIMA, in Canada. Given the current timeline, we expect to be producing commercial batches of product at PARIMA beginning in the fourth quarter of this year in support of additional planned launches by our partners.

With respect to the launch of Vitaros in Canada, we continue to support Abbott's efforts to enhance the product's commercial prospects. We believe that Vitaros, which is an approved product in Canada, is commercially viable in its current form, and as such, could be launched in Canada. However, we respect Abbott's current position, and we will continue to support their efforts to introduce Vitaros in the Canadian market.

As you may know, Abbott recently agreed to sell its non-U.S. developed markets specialty and branded generics business to Mylan. We have confirmed that this pending transaction includes Abbott Canada and, specifically, our product, Vitaros. Given the pending acquisition of Abbott Canada by Mylan, which is projected to close early next year, at this time, we cannot provide any further guidance concerning the future plans for Vitaros in Canada. As such, we will continue to communicate with Abbott on this matter in the coming months to gain a better understanding of the plans for Vitaros in Canada, and we'll update the market on any decisions made, as that information is made public by Abbott and/or Mylan.

In the United States, we are continuing to discuss with Actavis the opportunity to explore various options available to move Vitaros' clinical development program forward in the United States. Similar to the Abbott situation I just described, Actavis continues to be a company in transition, and as such, our efforts regarding Vitaros have and will continue to be influenced by this operational reality. Therefore, we will continue to push the process forward, and we'll update you when we have more clarity.

As you've seen, we've made some important announcements over the past few days. Yesterday, we announced the appointment of Sandford Smith to our Board of Directors. And this morning, we announced that we had entered into a $22 million equity financing agreement with one of our existing long-term shareholders, Aspire Capital. Last week, we announced that we entered into a partnership with the Scleroderma Research Foundation.

First, I'd like to make a few comments on Sandy. Sandy brings to Apricus a wealth of industry experience at the highest level of senior management, as well as board service with some of the most successful companies in the life science field. Sandy has an impeccable career with leading companies such as Genzyme and Bristol-Myers Squibb. As an example, Sandy joined Genzyme in 1996 and was there until the time when they were acquired by Sanofi in 2011. While at Genzyme, Sandy ran their international business, which he grew to represent more than 65% of Genzyme's total revenues. He was also responsible for the successful launch of 12 new products in several therapeutic areas around the world. Sandy will be key in helping us execute on our corporate strategy as we move the company forward.

We are pleased that we've been able to attract such accomplished individuals from the industry to our organization more recently, including Dr. Wendell Wierenga, who has 4 decades of experience in research, drug discovery and drug development, including clinical research, reg affairs, manufacturing, medical affairs. And more recently, Neil Morton, who has joined our management team, who has a successful track record in business development in specialty pharmaceuticals, focused on building product pipelines. Each of these individuals has substantially enhanced the profile of our organization and will be instrumental in helping us execute on our strategic objectives.

Turning to our other news this morning. We announced a stock purchase agreement with Aspire Capital. Steve will discuss the terms of this financing in greater detail later in the call, but I would like to share a few thoughts with you regarding this agreement. First, it is important to note that Aspire has been, and we expect will continue to be, a committed Apricus shareholder. Aspire has taken the appropriate steps to better understand our business and our strategy, and we believe that their commitment to Apricus with this agreement reflects their confidence in our organization.

I also want to say that as we assess our funding needs going forward, we will continue to prioritize shareholder-friendly solutions to include use of the Aspire agreement, as well as various forms of non-diluted capital to advance our business.

Last week, we announced an exciting multiyear partnership with the Scleroderma Research Foundation or SRF. Our partnership with SRF will be useful in raising awareness of Raynaud's phenomenon in the patient population, as well as providing us access to the foundation's extensive network of key opinion leaders that we believe will be beneficial to the RayVa clinical development program, which is currently underway.

I'd like to spend a few minutes on the RayVa clinical development program. RayVa leverages our DDAIP permeation enhancer platform technology, combining it with alprostadil, a vasodilator and a formulation that is topically applied to the affected extremities, and the case of RayVa, namely the fingers and toes of Raynaud's patients.

For those of you who are unfamiliar with Raynaud's, it is characterized by vasoconstriction in the hands, feet or other extremities, resulting in reduced blood flow and the sensation of pain, which can become severe. It is classified as either primary or secondary. Primary Raynaud's, which is not associated with an underlying medical condition, refers to vasoconstriction associated with exposure to cold or stress. Primary Raynaud's affects an estimated 3% to 5% of the U.S. population. Raynaud's disproportionately affects women, with the ratio of affected women to men of approximately 5:1. Secondary Raynaud's, with symptoms similar to those of the primary condition mentioned above, is driven by an underlying medical condition such as scleroderma, lupus or rheumatoid arthritis. There is estimated to be approximately 500,000 patients with secondary Raynaud's in the U.S.

The indication we are initially pursuing with RayVa is Raynaud's phenomenon, secondary to scleroderma. There are an estimated 100,000 patients with scleroderma in the U.S., of which women comprise 80% of the patient population, and approximately 90% of scleroderma patients have Raynaud's. There is currently no approved therapy for Raynaud's in the United States, representing a significant unmet medical need. Compounds being tested in clinical trials for Raynaud's include calcium channel blockers, oral PDE5 inhibitors and topical nitroglycerin, the latter having significant adverse effects. Similarly, calcium channel blockers, angiotensin II receptor blockers, oral PDE5 inhibitors and nitrates are used off label for the treatment of Raynaud's, highlighting the unmet medical need in the condition. In spite of the availability of these off-label products, the benefit to patients had been limited, and our market research suggests that RayVa, if approved, would be used as first-line therapy to treat secondary Raynaud's, with the potential to generate peak sales revenue of approximately $200 million in the United States.

We are on track to begin enrollment in the RayVa Phase IIa clinical trial in the second half of this year for patients suffering from Raynaud's phenomenon secondary to scleroderma. The trial will be a randomized, double-blind, placebo-controlled trial in approximately 50 patients, 5-0 patients, with Raynaud's secondary to scleroderma. Each patient will receive applications of placebo and doses of RayVa in a crossover design. This dose-ranging study will evaluate hemodynamic and temperature changes at the site of application in response to a cold challenge, as measured by Laser Doppler and thermography. Other endpoints include safety and pharmacokinetic assessments.

Enrollment for this Phase IIa trial is expected to take approximately 3 months, and we have partnered with the Scleroderma Research Foundation and with the Raynaud's Patient Advocacy Leadership in the U.S. to educate patients on our program and to encourage their participation in the trial. Based upon the results of the Phase IIa trial and regulatory guidance received from the FDA, the company will work towards moving RayVa into a further clinical study designed to evaluate the safety and efficacy of RayVa in patients suffering from secondary Raynaud's, sometime in 2015.

The FDA had indicated that RayVa may qualify for a priority review, given the unmet medical need and the lack of approved products to treat secondary Raynaud's. The FDA will determine if the RayVa New Drug Application qualifies for priority review, following its anticipated submission, which could occur as early as 2017.

Lastly, I want to provide an update on Femprox. Earlier this year, we initiated a compressive strategy to out-license the development and commercialization rights for Femprox in Europe, while seeking to retain commercial rights in the United States to preserve long-term asset value. As we mentioned in the past, we are seeking a Europe first strategy, as we believe that potential European partners would be interested in Femprox, as there may be a quicker path to market in Europe. While we have made progress in our efforts to out-license Femprox, our process is still ongoing, and as such, we will update the market as circumstances dictate.

In closing, I would like to reiterate that we will continue to execute on the corporate goals that we laid out in the beginning of the year. Vitaros has been launched in Europe by our commercial partners. We have begun to build a diversified pipeline of novel therapeutics, starting with the initiation of the RayVa IIa clinical trial later this year. We've strengthened our balance sheet through the committed equity financing with Aspire Capital. And we have added depth and breadth to our Board of Directors and management with the additions of Dr. Wendell Wierenga, Mr. Sandy Smith to our board; as well as Mr. Neil Morton as our Vice President of Business Development.

With that, I'll turn the call over to Steve to discuss our second quarter financials. Steve?

Steven R. Martin

Thank you, Rich. We filed our quarterly report on Form 10-Q with our second quarter 2014 financial results with the U.S. SEC yesterday afternoon. In addition, we provided condensed comparable 2014 and 2013 financial tables in our press release that was issued this afternoon.

Total revenues for the second quarter ended June 30, 2014, were $5.5 million compared to $1.2 million in the same period in 2013. The increase in revenues in 2014 was related to the recognition of licensed revenues associated with the out-licensing of Vitaros in certain European territories, including France and Spain with Laboratoires Majorelle and Recordati, respectively. These revenue amounts related to monies recently collected from the partners associated with the out-licensing at Vitaros in European territories, which was deferred through March 31, 2014. The revenue related to the Majorelle territories, including France, is partly reflective of the withdrawal of the previous alleged claims against the company. We look forward to a successful relationship with our licensee partner, Majorelle, as they commercialize Vitaros in the French market.

Net income for the second quarter ended June 30, 2014, was $1.9 million or $0.05 per share on a fully diluted basis, compared to a net loss of $3.9 million or $0.12 per share on a fully diluted basis in the 3-month period ended June 30, 2013. The significant increase in revenues and the reduction in net loss in the second quarter of 2014 are reflective of the continued focus by management on the primary valuation driving initiatives established for this fiscal year and into 2015. As of June 30, 2014, our cash balance was $17.4 million compared to $21.4 million as of December 31, 2013. This included $5.5 million in cash collections for the upfront license fees related to the recent Vitaros European license agreements and $2.2 million from sales of equity through the aftermarket stock selling facility, offset by $1.5 million of principal payments on the remaining debt and for general, operating and administrative expenses.

In the third and fourth quarters of this year, we expect to begin to collect the initial royalty revenues from partner sales of Vitaros in Europe. These revenues will be based on sales reports received from licensee partners and will reflect their in-territory sales of products, multiplied by the applicable contracted double-digit royalty rates. These royalties will be received on a 1-quarter lag from the time sales are made by our licensee partners. We expect our expenses for the rest of the year will include costs to complete the Vitaros room temperature device and supporting our clinical development activities.

Today, we announced that we entered into a common stock purchase agreement with Aspire Capital. This new agreement with Aspire Capital will allow Apricus to sell shares from time to time on market-based terms to a committed long-term investor. Apricus will control the timing and amount of equity fundraising through this agreement. We believe that we have an appropriate level of cash and access to additional capital through the Aspire agreement to support the current operating plan through 2015. As a company, we have carefully considered the financing options available to us and believe that this equity financing structure is appropriate for our stage of development. Our decisions for making equity sales to Aspire will be dictated by our cash needs on a monthly basis, the overall market conditions and our analysis of other forms of cash-generating vehicles available to us.

It should also be noted that, today, we filed an S-3 shelf registration statement with the SEC. The company's existing S-3 registration statement expires in January 2015, and it is important for the company to be ready at all times to access public sources of capital, including equity and debt. The filing of this registration statement is a prudent step to allow us to access the markets on an efficient basis, if needed in the future. This filing is not an indication that the company has established plans to raise additional equity capital beyond the terms of the Aspire equity line.

I will now turn the call back over to Rich.

Richard W. Pascoe

Thank you, Steve. In closing, I firmly believe that Apricus remains on an exciting new path to creating value for patients, healthcare providers and shareholders, as we pursue our vision of being a leader in advancing innovative medicines to meet the needs of patients. Importantly, we have delivered on the key corporate goals that we laid out in the beginning of the year. Vitaros was launched in Europe by our commercial partners. We have begun to build a diversified pipeline of novel therapeutics, with the initiation of the RayVa Phase IIa clinical development program. We've strengthened our balance sheet to the committed equity financing with Aspire Capital and have added depth and breadth to our Board of Directors and management team with the additions of Dr. Wendell Wierenga, Mr. Sandy Smith to our board; as well as Mr. Morton as our Vice President of Business Development.

Looking forward, we will continue to execute on our strategy, with the focus on creating long-term value for our shareholders through multiple value-creating milestones in 2014 and beyond, including additional Vitaros launches by our partners, the generation of meaningful Vitaros royalty and milestone revenue, exploring options to advance Vitaros' clinical development in the U.S., enrolling patients in the RayVa Phase IIa clinical trial, completing the Vitaros room temperature device development program and expanding our development stage product pipeline.

As always, we appreciate the support and feedback we receive from our shareholders. And with that, we would now like to open the call to questions. Operator?

Question-and-Answer Session

Operator

[Operator Instructions] Our first question comes from the line of Andrew Shottery [ph] with Roth Capital.

Scott R. Henry - Roth Capital Partners, LLC, Research Division

This is Scott Henry. Just a couple of specific questions. For starters, Femprox, I'm just trying to get some guidance on whether you think you can do an out-license in 2014. I know that was kind of originally a goal, but we're into the second half. I mean, would you say in 2014/'15? Or is '14 still a goal for a partnership there?

Richard W. Pascoe

Scott, thanks for the question and thanks for the well wishes. And certainly, you're correct, that it is a goal of ours to out-license Femprox to a partner that can take that forward, given the reasons that we've described earlier. And it is a goal to accomplish that in the shortest timeframe possible. What I'll say is that there's a select group of players out there who are interested in the female sexual dysfunction space. There's still a bit of uncertainty, I'll call it, that exists in this market, given some of the pending decisions to be made in the U.S. relative to the Sprout Pharmaceuticals product. And as such, we think that those conditions and issues are affecting our process as well. And so it's difficult for me to give you a specific answer, but I will say that it's our goal to out-license it as soon as possible. I think that as there's more clarity on the reg front, that we'll be able to make more definitive statements about where we're going.

Scott R. Henry - Roth Capital Partners, LLC, Research Division

Okay. Fair enough. And then shifting to RayVa. Just trying to get an idea of the timing here. I mean, you said second half '14. Do you expect to start that trial in Q3 or Q4? And also, what is the follow-up once the last patient is enrolled?

Richard W. Pascoe

Yes, great question. So the RayVa program, we're really excited about it. As you know, it's a great opportunity to utilize our platform technology as a permeation enhancer, alprostadil, and a different formulation to treat patients, who we think are in great need of something to help them with their condition. We have made substantial progress on gearing up the trial, including working with our contract research organization, identifying sites. We've manufactured the clinical trial material. That's sitting in our vendor's warehouse right now, ready to be distributed to the various sites that will run this trial throughout the country. And we've been working with the patient advocacy groups, as well as the Scleroderma Research Foundation to enlist and support enrollment in this trial. So we are poised to begin the trial soon. I would expect that by the end of this quarter, we'll have sites up and ready to accept patients. As we said before, our enrollment rate is approximately 3 months, and that's based on, I think, a very firm estimate of enrollment on a site-by-site basis. And to your question on follow-up, the way this trial is designed, patients will come in, they will be given either placebo or 1 of the 3 doses that we'll be testing in this trial. And then there'll be approximately a 7- to 10-day period that they will be asked to come back and they will receive either control or active, depending upon what they had the first time. So a placebo in 1 dose, and then from there, there will be some follow-up, but no long-term follow-up is required, meaning that once the data is collected, thermography, Laser Doppler, there will obviously be some monitoring of the patient for a few days from a safety perspective. But after that, they're sort of free to go. So this isn't a situation where we have a long-term follow-up schedule. And as such, we would look to be able to crunch the data pretty quickly and get something out to the market.

Scott R. Henry - Roth Capital Partners, LLC, Research Division

Okay. So it sounds like from start of enrollment to data, it's probably less than 6 months with this trial.

Richard W. Pascoe

That is correct.

Scott R. Henry - Roth Capital Partners, LLC, Research Division

Okay. Final -- and a final question on Vitaros. Just trying to think of how we can quantify this European launch in terms of -- what do you think the revenue potential here is? I would certainly agree that reorders this soon in the launch is a very positive sign. But I'm just trying to think about how I can quantitatively analyze that launch.

Richard W. Pascoe

We've continued to maintain that we believe the market for this drug in Europe, specifically, is rather attractive. Our estimates are -- what we've shared publicly is in the range of $300 million at peak. And I think if you look at the market in Europe right now, estimates range between $1.3 billion and $1.5 billion in overall erectile dysfunction treatment sales, which those numbers vary primarily because of other indications that drug, such as Cialis, are used for. But I think it's fair to say it's a big market, and a $300 million is a substantial amount of business that we think our partners can generate, based on what we know about the market. You're right, it is difficult at the moment for us to describe the launch in quantitative terms beyond what we think is a great early return, if you will, in the form of reorders by our partner, Takeda. You recall they just launched about 2 months ago, less than 2 months ago, and are ahead of our production schedule already, which we think is a good sign. And as I said in my prepared remarks, I think it's really is a function of the efforts and the work that Takeda has put into successfully launching Vitaros in Europe, as our first partner to do so. And I really want to acknowledge on the phone here today that we are thrilled with the work that they've done, the thoughtfulness they've put into their launch, the comprehensive approach they've taken, and I think that's, at least early, bearing fruit from our perspective.

Operator

[Operator Instructions] Our next question comes from the line of Kaey Nakae with Ascendiant.

Kaey T. Nakae - Ascendiant Capital Markets LLC, Research Division

Just following up on the Vitaros comment. I guess, 2 things. One, first of all, pricing for Sweden, is that going to be similar to what we're seeing in the U.K.?

Richard W. Pascoe

Kaey, yes, we haven't put out specific pricing information for other partner launches. I think it's fair to say that each of our partners makes the pricing decision for Vitaros independent of each other, as you would expect. But they are all very consistent in their thinking on pricing, which follows sort of a basic formula. A, they, like us, believe that this product should and will support premium pricing in the market, and they have priced it as such. And I think if you look at the U.K. launch, specifically, where the product is selling in the neighborhood of GBP 10 to GBP 15 to the wholesalers is a pretty good marker for the rest of Europe.

Kaey T. Nakae - Ascendiant Capital Markets LLC, Research Division

Okay. And then just in terms of the reorder by Takeda, in terms of the size of the adversity, the initial placement, can you give us some thoughts on that?

Richard W. Pascoe

Yes, I, we -- and I guess, recognition of our relationship with them, we want to make sure we don't share too many details. Suffice it to say that our batch sizes for this product are set, and we, I think, do a very good job of managing the supply chain with and for our partners. And as such, the fact that they are ordering -- reordering, I should say, product ahead of our internal schedule and, fortunately, we have the capacity to make that happen with our partnership with Therapex and soon to be with PARIMA making product. We can accomplish what's been set out here in terms of those reorders. But suffice it to say that it's for multiple batches of products.

Kaey T. Nakae - Ascendiant Capital Markets LLC, Research Division

Okay. And then just as far as, at least, known milestone payments that you're going to be receiving in the second half, you're going to get something from Sandoz for Sweden in the back half of the year. Is that the correct assumption?

Steven R. Martin

Yes, Kaey, this is Steve Martin. So we've already indicated that we're going to receive a $500,000 milestone from Sandoz related to Sweden, and dependent on the pace and the territory from other partners that we also have a good chance to receive other milestone monies in the back half. So the size that you saw related to the Sweden territory is reasonable to expect in other cases, but I'm not able to guide right now on which territories or which partners, because we haven't guided on the specific launch dates. But there are other similar milestones over the next, we'll call it, 18 months.

Kaey T. Nakae - Ascendiant Capital Markets LLC, Research Division

And in reading the 10-Q last night, it looks like you expect to receive another $1 million from Majorelle, maybe, I guess, perhaps in Q4.

Steven R. Martin

Yes, you'll notice that a couple of our arrangements, we receive cash, both Majorelle and Sandoz, and we have it deferred in the balance sheet and in other contractual arrangements that need to be still delivered, related to those license arrangements. So do not expect any additional cash related to the Majorelle transaction, but there is pent-up revenue that will come, we expect, in 2014.

Kaey T. Nakae - Ascendiant Capital Markets LLC, Research Division

Okay, great. And then just finally, with respect to the RayVa study, you announced you've got the protocol fairly well defined. I guess, 2 questions. One, how soon after the administration of either the drug or placebo do you do the test? Is it a couple of the minutes or longer? And then number two, how much do you now anticipate the total cost of the study will be?

Richard W. Pascoe

Kaey, so on the first question, the way the protocol is designed, the patient, obviously, will be screened properly. Once they are enrolled in the study, they'll be assigned initially to either active or placebo. And they will -- the product will then be applied to the hand by a -- one of the study managers. And then shortly after that, within minutes, they will be exposed to a cold challenge, which is a way to essentially induce the symptoms of the condition in the clinicians' setting. And then from there, we will assess over time the various parameters, using the Laser Doppler and thermography equipment. So all this happens, to answer your question, in very close proximity. So the visit itself will encompass, of course, some additional data collection along the way. But one of the things we really are interested in, in this Phase IIa study, is understanding not only what the duration of the product is at various doses, but also to try to get a better understanding of the PK parameters and other essential elements that will help inform us in the Phase IIb trial. Cost is approximately $1.5 million, which we've talked about before, and we are still comfortably in that range. And that's just one follow-up, I think. As you know, that number is sort of baked into our operating projections and budgets and is included in the cash run rate that Steve described in his previous remarks.

Operator

[Operator Instructions] Our next question comes from the line of Irina Koffler with Cantor Fitzgerald.

Irina Rivkind - Cantor Fitzgerald & Co., Research Division

So I just wanted to follow up on the manufacturing questions a little bit more. So you guys guided that you will be receiving primarily milestone revenue and a little bit of royalty revenue in the back half of the year, over the next couple of quarters. But just wanted to understand transfer pricing a little bit better in the sense of when Takeda puts in these additional orders for batches, do they pay at the time that they receive the batches or at the time that they place the orders? Can you walk us through that? And whether or not there's going to be any transfer pricing we should expect in the next couple of quarters?

Steven R. Martin

Irina, good question. This is Steve. So there's a couple of elements related to all of our license agreements. We often are involved as a manufacturer or as a supporter to the manufacturing organization. So we have a contract manufacturing arrangement with Therapex, a company based in Canada, and Therapex is our primary manufacturer today. We have a second one coming online, and it's on track. It's called -- a company called Groupe PARIMA. But the arrangement is that the orders are placed through Apricus to the contract manufacturer, Therapex, and then Apricus is involved in making sure that the product is delivered to the licensee specs. And when we deliver that, we invoice that licensee, for example, Takeda, and generally, there's a small markup. So yes, we would expect over time to recognize -- and we have recorded some of those sales, but we haven't yet recognized the value of that transfer price sale, with a very small markup versus the cost of goods related to that sale. So in short, our elements of revenue will be product sales minus cost of sales. We will have some milestones that record in license, and we'll also have royalties in the back half of the year. You will start to see all 3 of those elements, as we head to the second half of the year.

Irina Rivkind - Cantor Fitzgerald & Co., Research Division

Okay, great. And then is this first manufacturer sufficient for you until you get the second one up and running, in terms of your manufacturing needs? Or are you -- do you have any concerns around that?

Richard W. Pascoe

Yes, no, there's ample capacity at Therapex to manufacture product for the needs of these launches, the ones that have occurred, the reorders and the pending launches. Just to put it in perspective, it takes just a few days to manufacture batches for each of our partner. Of course, there's stability working things that have to be done and analytical work that has to be done. But in terms of sort of time in the plant, it's fairly minimal. And as we noted earlier, the work that we put into bringing on a second source of supply at PARIMA is on track, on schedule. We've made product there. In fact, we made the RayVa clinical trial material there, which, of course, incorporates much of the same technology. So we feel very good about PARIMA's ability to make product, as either a primary or secondary source. And we would expect that both facilities would be in a position at year end to do just that. So we feel good about this supply chain right now. And are certainly, we're making product, shipping product and managing that appropriately.

Irina Rivkind - Cantor Fitzgerald & Co., Research Division

And then just qualitatively on the European launch. I saw in your presentation the promotional materials Takeda is making. And just wanted to understand qualitatively in the sense of, are they sampling now and you're expecting physicians to kind of be just trying the product in some of their more resistant patients that don't have responses to Viagra, et cetera? They try then to kind of pick out steam and have more regular use? I mean, how are you thinking about the launch?

Richard W. Pascoe

Well, and again, and I want to make sure that we're being sensitive to our partner's request, but at the same time, it's clear to us that patients are using the drug, both as a sample product and commercial product. And prescriptions and product -- commercial product is flowing through the retail channel into the hands of patients. And so I would say both, clearly, Takeda, as well as other partners, will rely upon sampling to get those patient starts. And I think, again, I want to applaud Takeda's efforts in particular here because they have done all the right things, in my opinion, to be successful with this product in Europe. And that includes working with the top prescribers, urologists primarily, to educate them on the product, making sure that product is available so that when prescriptions are written, they can be filled, and ensuring that there's adequate patient educational materials available so that the proper technique to apply the product and the use of product, and more importantly, to give the patients the requisite information they need on safety is made available to them. And so I think if we had to conjure, if you will, a launch that we can all be proud of as a first launch of this product, certainly, our friends at Takeda have lived up to our expectations, and in fact, from our perspective, have exceeded expectations.

Operator

Mr. Pascoe, it appears we have no further questions at this time. I would now like to turn the floor back to you for closing comments.

Richard W. Pascoe

Thank you, operator, and thank you, all, for being on the call today. We hope to see many of you at our presentation at the Cannacord Health Care Conference tomorrow in Boston at 3 p.m., as well as other investor conferences later this year, including the Rodman & Renshaw Conference in New York City in September, as well as the Stifel Conference, also held in New York City, later in November. Thank you.

Operator

Ladies and gentlemen, this does conclude today's conference call. You may disconnect your lines at this time. Thank you for your participation, and have a wonderful day.

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Source: Apricus Biosciences' (APRI) CEO Richard Pascoe on Q2 2014 Results - Earnings Call Transcript

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