Executives
Shawn Patrick O'Brien - President and Chief Executive Officer Norman Evans - Chief Financial Officer Joan Chypyha - General Manager and President of Cipher Canada Peter Weiler - Vice President and Business Development Joe Pecora - President and General Manager of Cipher USA
Analysts
David Dean - Cormark Securities Inc. Jason Napodano - Zacks Investment Research Joseph Walewicz - Laurentian Bank Securities Douglas Loe - Euro Pacific Canada
Operator
Good morning, ladies and gentlemen. Thank you for standing by.
Welcome to the Cipher Pharmaceuticals Fiscal 2015 First Quarter Results Conference Call. At this time, all participants are in a listen-only mode.
Following today’s presentation, instructions will be given for the question-and-answer session. [Operator Instructions] As a reminder, this conference is being recorded today, Wednesday, May 13, 2015.
On behalf of the speakers that follow, listeners are cautioned that today’s presentation and the responses to questions may contain forward-looking statements within the meaning of Safe Harbor provisions of the Canadian Provisional Securities Laws. Forward-looking statements involve risks and certainties and undue reliance should not be placed on such statements.
Certain material factors or assumptions are implied in making forward-looking statements and actual results may differ materially from those expressed or implied in such statements. For additional information about factors that could cause actual results to vary include those identified in the company’s Annual Information Form, Form 40-F and other fillings with Canadian and U.S.
Securities Regulatory authorities. Except as required by Canadian or U.S.
Securities laws, the company does not undertake to update any forward-looking statements. Such statements speak only as of the date made.
I would now like to turn the conference over to Mr. Shawn Patrick O'Brien, President and Chief Executive Officer of Cipher Pharmaceuticals.
Please go ahead, Mr. O'Brien.
Shawn Patrick O'Brien
Thank you, Jonathan, and good morning everyone. Thank you for joining us.
With me as usual is Norm Evans, our Chief Financial Officer and today’s call we are joined by Joan Chypyha, General Manager and President of Cipher Canada; Peter Weiler, Vice President and Business Development; and our newest addition to the team Joe Pecora, President and General Manager of Cipher U.S.A. For today’s call, I will begin with a review and highlights and key developments for the quarter.
Norm will then review the financial results for Q1 in detail. And I'll return for some concluding comments before opening the call to your questions.
Last year, I communicated a new growth strategy for the company. One intended to transform Cipher from our royalty stream company with three products to pure play dermatology company, capitalizing on the company’s core capabilities and clinical and regulatory affairs, product licensing, supply chain management, marketing and sales.
Our strategy is focused around three objectives, acquired dermatology companies or product in the United States and established commercial infrastructure, expand Canadian dermatology franchise and to acquire and develop potentially transformative technology that can be commercialized efficiently. The first five and a half months of 2015 have been very active and tremendously successful period in executing the strategy.
Since the beginning of the year we’ve completed six transactions adding 13 products the vast majority of which are commercialized or late stage plus seven pre-clinical assets in achieving a major milestone in the development of our sales and marketing infrastructure.
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Two it significantly expands and strengthens our product portfolio adding seven revenue-generating products several of which we believe with the appropriate investment and enhanced marketing efforts has tremendous revenue potential for Cipher. Due to capital constraints, Innocutis marketing budget for its entire product line in 2014 with the same as ours for Epuris in Canada.
Third lead product Sitavig is the only proven treatment to reduce the occurrence of cold sore outbreaks and have strong patent protection. Launched last summer, we believe with the right market message and the right distribution strategy Sitavig can be a $100 billion product a year.
Nuvail is a new unique patented polymer that is applied to nails for managing signs and symptoms of nail dystrophy. With opportunities to promote its benefits along side treatments for onychomycosis the most common type of nail dystrophy, which can be a slow process.
We believe Nuvail has a potential to be a $30 million a year product in the United States. I am pleased to report that just a few short – since complete in this transaction actually one-month ago today, we’ve already seen changes in the trajectory for Sitavig and Nuvail.
Innocutis also provides a commercial platform in the United States for the products which we acquired the worldwide rights from Astion Pharma at the end of February, that target common chronic conditions that are insufficiently addressed today. Specifically the two late stage products Dermadexin and Pruridexin, Dermadexin is a patent protected topical barrier-repair cream approved in the EU last year as a Class III medical device for the treatment of seborrheic dermatitis, an inflammatory skin disorder.
Pruridexin is a patent protected topical cream for the treatment of chronic itching which was submitted to the European Medicines Agency in last year as a Class III medical device and it’s currently under review. There is a sizable opportunities for these two products, we believe we can achieve combined sales of more than $40 million and aim to submit both for U.S.
regulatory approval before the end of June with the submission for Canada to follow. With the Astion Pharma deal we also acquired the global rights to ASF-1096 a product candidate in Phase II that has been investigated for the treatment of discoid lupus, a severe, chronic, inflammatory and disfiguring skin disease that has been awarded orphan drug status in the EU and we will pursue similar status in the United States.
Importantly the team at Innocutis shares are fundamental – perform engaging with and listening to customers for success in the dermatology space. Our discussions with Joe and Jonathan originally began around the potential to license for Canada.
However we quickly realize that there is much more bigger opportunity here one is resulted in a major step forward in our vision to be the most customer centric dermatology company in North America. Concurrently with the acquisition of Innocutis we closed on a private debt offering of US$100 million in five-year senior secured note with a number of investments funds managed by Athyrium Capital, New York.
We immediately drew down $40 million to fund the majority of our upfront purchase of US$45.5 million for Innocutis. The remaining balance of the notes is available for future acquisition activity subject to certain condition.
The Innocutis transaction was completed at a multiple of 4.2 to last year's net sales well below the mid range for the company’s with a portfolio of this nature and we believe ultimately reflects the unique opportunity for our company. It will require investment in short-term, however as we stated we fully expect this acquisition to be accretive within two years.
In terms of execution on the Canadian component of our strategy as I discussed in our call in February, we took a number of steps forward in building our dermatology portfolio at the beginning of the year acquiring the Canadian rights to Ozenoxacin, a treatment for adult and pediatric patients with Impetigo from Ferrer and having our Beteflam Patch for the treatment of inflammatory skin conditions accepted for a review by Health Canada. That momentum has continued since our last call.
At the end of March we acquired the Canadian distribution rights for CF-101, a novel chemical entity being developed by Can-Fite Biopharma for moderate to severe plaque psoriasis and rheumatoid arthritis. Since our announcement Can-Fite has reported positive results from a 32-week Phase II/III trial with the data suggesting that CF-101 may be a potential first-line systemic therapy for patients for the moderate to severe plaque psoriasis.
Analysis of the entire study showed by 32 weeks of treatment CF-101 33% of the patients achieved Psoriasis Area Sensitivity Index on PASI score up 75 meaning that they achieved 75% or greater reduction in the PASI score from baseline. This was significant cumulative and linear improvement throughout week-16 through 32.
Most significantly by week-32 of the study 20% of the patients reached the PASI score of 90 which is the most stringent and difficult to meet in clinical endpoints for measuring responses to psoriasis treatment. Based on the positive results Can-Fite is initiated work on the design to the next advanced stage clinical trial protocol.
We see CF-101 as being complementary to our Beteflam Patch giving us two products targeting psoriasis in Canada. We hope to submit CF-101 for approval in Canada after Can-Fite successfully completes to the Phase III registration program.
Last week we further strengthen our Canadian dermatology portfolio with the acquisition of the Canadian rights to Vaniqa and Actikerall from Spanish Pharmaceutical Company Almirall. Vaniqa is a prescription cream clinically proven to reduce growth of unwanted facial hair in women that works by blocking the enzyme necessary for hair to grow.
Actikerall is the topical treatment for slightly palpable and/or moderately thick hyperkeratotic actinic keratosis, which is a pre-cancerous patch of thick, scaly, or crusty skin. Actikerall has been shown to be superior to placebo and non-inferior to diclofenac gel.
Both products are approved by Health Canada and will fit seamlessly into our existing sales infrastructure in Canada. Combined these two products of sales potential up to $4 million annually in Canada and we expect them to have them on the market next month for Vaniqa and we expect to launch Actikerall by the year-end.
As I said at the outset we've been active in all three components of our growth strategy this year and as discussed on our last call early in the first quarter we added transformative dermatology technology to our business with the acquisition of the assets of Melanovus Oncology, which included seven preclinical compounds for the treatment of melanoma and other skin cancers. Melanovus has the exclusive global license of a library promising compounds and related IP from the Penn State Research Foundation targeting the deadliest of the skin cancers.
Finally, before I turn the call over to Norm to discuss our financial results I’d like to take this opportunity to provide an update on our patent infringement lawsuit for Absorica. As a reminder together with our marketing partner for Absorica in the United States, Sun Pharma previously known as Ranbaxy, we launched a patent infringement lawsuit against Watson now known as Actavis following their submission of Paragraph IV Certification Notice to the FDA in September of 2013.
Early this past April as a normal part of the process a pretrial hearing called The Markman hearing occurred which is intended to determine the precise meaning of the words from a patent claims that are in dispute such as suit. The outcome of the hearing was such that all five of the terms under review were constituted by the court in our favor.
I want to be clear that no ruling was made around the infringement or validity of the patents, but we do believe The Markman outcome strengthened our position going into the trial which is expected sometime towards the end of this year or the beginning of 2016. Norm, I’d like to turn it over to you.
Norman Evans
Thank you, Shawn and good morning everyone. We entered the 2015 fiscal year with strong growth momentum in our existing commercial products.
We saw continued growth in total revenue and adjusted EBITDA when we normalized for the transaction costs incurred. Q1 was a very active first quarter of 2015.
Total revenue grew 17% to $9.2 million in Q1 2015 from $7.9 million in Q1 2014, which was predominantly driven by the continued strong performance from our isotretinoin products that’s Absorica in the U.S. and Epuris in Canada as well as Lipofen which had the strong performance in the quarter as well.
Revenue from Absorica, increased by 95% to $6.3 million for the quarter from $6.0 million in Q1 2014 driven by continued steady market penetration in the U.S. and a continued expansion of the overall isotretinoin market.
Prescriptions for Absorica in Q1 2015 were up by 5.6% compared to Q1 2014. In terms of other growth opportunities for the product our partner Sun continues to work on additional formulary coverage to increase the number of covered lives in the U.S.
Product revenue for Epuris on the Canadian market grew 139% in Q1 2015 to $0.8 million from Q1 2014 it was driven a continued increase in market share to 17.6% in March 2015. In Q1 2015 prescriptions grew by 162% over the prior year and we continue to receive positive feedbacks from the Canadian dermatology community.
Gross margin for Epuris was 71.3% for the period up from 70.6% in Q1 last year. Lipofen achieved strong revenue growth for quarter with revenue increasing $0.5 million or 40% in Q1 of 2015 to a total of $1.6 million for the same period in 2014.
As expected prescriptions continue to move from the branded to the generic, roughly 45% of the prescription volume in Q1 2015 was for the brand and 55% for the authorized generic. This is a positive transition for us, as we received better economics with the authorized generic version of Lipofen.
Lastly, our extended-release tramadol product ConZip in the U.S. and Durela in Canada contributed $0.5 million in net revenue in Q1 2015 compared to $0.4 million in Q1 2014 and the Canadian market sales of Durela in Q1 2015 were 34% higher than Q1 2014.
Now taking a look at our expenses for the quarter for selling and marketing expense reduced slightly to $0.6 million in Q1 2015 from $0.5 million in Q1 2014 reflecting an increase in the additional sales and marketing effort for Epuris promotion in Canada. As expected, general and administrative expenses also increased over the prior year, as we continue to expand our product portfolio and deliver against the three components of our growth strategy.
G&A expense was $3.5 million in Q1 2015 compared to $1.8 million in Q1 2014. The increase in G&A reflects additional resources for business development activities, as well as increased stock-option expense, which result from the ongoing increase in the stock prices.
We also incurred certain expenses related to the product acquisitions that were announced during the quarter and other initiatives related to future growth opportunities including the acquisition of Innocutis. R&D expenses totaled $1.1 million which are included in G&A expense for the quarter.
Looking at profitability now Q1 adjusted EBITDA including those transaction cost during the quarter of $5.1 million compared with $5.2 million for the same period last year. However if we exclude the $1.1 million in those transaction costs incurred were by adjusted EBITDA would have risen 15% to $6.2 million in Q1 2015 compared to Q1 2014.
Net income for the quarter was $3.2 million or $0.12 per basic share compared to $3.8 million or $0.15 per basic share in Q1 2014 again with Q1 being impacted by those transaction costs. Our cash balance at quarter end was $47.1 million compared with $52.6 million as of December 31, 2014.
The decrease in cash is mainly attributable to the acquisitions completed during fiscal 2015. The Astion acquisition loan use $6.0 million in cash during the quarter.
As Shawn discussed and certainly with the completion of the Innocutis transaction in April we closed on a private offering of US$100 million in five years senior secured notes of which we immediately drew down an initial amount of US$40 million, which was used to fund the majority of the purchase price for Innocutis. With the additional balance reflexibility and our continued strength strong cash position we will remain well-positioned to continue to execute on our growth plan moving forward.
With that, I would like to turn the call back over to Shawn.
Shawn Patrick O'Brien
Thanks, Norm. As I stated at the outset it’s been a very busy year to the start of 2015 and as a result of this activity Cipher’s beginning to look like a very different company than it was at the beginning of this year.
That along when I joined the company almost a year ago, but really we are just getting started. We expect continue to be active in each of the three components of our growth strategy expanding on our commercial base in United States, building out a dermatology and franchisee and investing prudently and potentially transformative dermatology compounds that will drive the long-term value for Cipher.
Our business development pipeline remains robust and we have the balance sheet in access to capital to execute augmented by our recent added note offering with [indiscernible]. We continue to adhere to our strict investment criteria, which has an internal rate of return at least 20% accretive to earnings within two years and a net present value positive in five.
Our stated goals are to leverage our established infrastructure in Canada to grow our derm business there to $15 million in revenue by 2020. That is larger than our entire business today and to leverage our new U.S.
commercial platform for existing and new products to generate $250 million in revenue by 2020 in the United States. With our achievements today we’re well on our way.
We’ll now open up the call to questions, operator.
Operator
[Operator Instructions] Your first question comes from David Dean with Cormark. Please go ahead.
David Dean
Good morning, guys. Thanks for taking the questions.
I'm hoping you can run us through some of the assumptions that bring you to the markets that you described for Sitavig and for Nuvail?
Shawn Patrick O'Brien
Bring us to the market upsize opportunity.
David Dean
Yes, I think you anticipate Sitavig being about $100 million market and Nuvail $30 million product and the Nuvail being a $30 million product in the U.S. ultimately just if you could run through some of the assumptions that would be appreciated.
Shawn Patrick O'Brien
Sure, I’ll just highlight David one – those two numbers actually are a target for 2020.
David Dean
Okay.
Shawn Patrick O'Brien
We think there is actually opportunity beyond that, but that’s our five-year target. And then I’ll let Joe answer – give you insights on the three critical things that we’re tackling for Sitavig to leverage the unique benefit that provides in the marketplace.
Joe?
Joe Pecora
Hey, David, thanks for the question. First of all Sitavig in order to drive it to the heights that we’re comfortable with.
The first thing is the market is very large, if you look at competitors like [indiscernible] stuff like that it’s a hundreds of millions of dollars for a target market. But the key to Sitavig is it’s the one and only treatment, it’s a one therapy and those benefit allow us to expand the market as well as coming on board with Cipher having the horsepower to invest behind the product.
So the opportunities itself in the market is huge, hundreds of millions of dollars are out there the investment behind us will allow us to penetrate that market in gaining share and most importantly the product is unique to the market. So that unique that’s getting it of the dermatology and even beyond for folks like dentistry and primary care, women's healthcare they’re all writers of herpes labialis.
So the opportunity is huge.
David Dean
Okay, and can you – what would the market share be required to get to that amount?
Norman Evans
In valued terms it’s roughly a 12% and the market is $1.6 billion today, it used to be a $4 billion market and as Joe highlighted price at – our lack is just over $300 for two tablets, only takes one tablet to treat our patients. So the cost at the wholesale level is just a little over $150 which is well behind some of the other products that Joe just highlighted in value terms.
So we think there is pricing opportunities for this brand United States and off to market penetration having the unique position of the only product that demonstrates reduction and recurrence. So on the long-term the key three things that Joe and the team are working on is distribution to make sure the patients have the product in hands fall in the program phase comes on that they can take it.
Secondly, is communicating the benefits of the customers throughout the marketplace and third is and doing that obviously on a long-term we think it’s more important to partner this product with other primary care providers through a relationship that we can get the distribution beyond the dermatologist. So it’s a stepwise investment strategy for this brand Paragraph IV, but really focused on the message, distribution and the benefits to the marketplace.
David Dean
Okay, great. And can we go through the same exercise on Nuvail?
Shawn Patrick O'Brien
Sure, Joe.
Joe Pecora
So again unique to Nuvail are two things, one is it's a reasonable product in Nuvail solution that allows folks with trauma, brittle nail syndrome, mycotic nails to all using Nuvail in fact about 20% of the population had some form of trauma or brittle nail syndrome. Our focus in the past is only been on the mycotic nails and as you know that become very competitive and I think the future was Nuvail we are looking to go to dermatology and podiatry and really kind of open up the market to look at brittle nails, to look at trauma, psoriatic nails and mycotic nails.
Again to open up the opportunity from a market perspective. And secondly with the product's its uniqueness is that it’s breathable, it helps to build the keratin in the nail and we are also looking at other opportunities on how to address folks who are using oral and topical antifungal's with Nuvail.
Shawn Patrick O'Brien
So David, I just want to remind you and the audience is underlying situation here in Innocutis spent combined total marketing on top of our sales force effort less than we did last year for our peers in Canada for 2014. So obviously it’s very difficult to get the kind of traction if your voices have been fully heard and supported in which you have additional sales force.
So it’s a marketing investment in both these brands to drive that message to the key size of customers.
David Dean
Okay, and that’s perfectly done to kind of a next question. So Innocutis was not a EBITDA profitable company last year or at least according to the time period within the bar.
So how should we be looking at it when we tried to model you know is that on a consolidated basis, I anticipate top line growth, but I also think it sounds like you're going to be investing in increased promotion. How do you recommend this – we model this?
Shawn Patrick O'Brien
Well, we don’t have any specific forward-looking guidance at this point in time I would remind everyone that today is the one-month anniversary of the acquisition. So we - our first priorities were we got that immediately after the closing, started working with our new U.S.
management team on the integration activities. Yes, we’re looking at the product opportunities and the appropriate amount of spend on each product to make to sure growth to meet our expectations going forward obviously any time that you are investing in growth through the future it’s going to affect your short-term bottom line.
So but the amounts that we are going to be spending the appropriate amount we spending on marketing support for each of those products is still to be determined.
David Dean
Okay would you…
Shawn Patrick O'Brien
I don’t have anything specific for you at this point in time because we’re in the midst of building out plans right now.
David Dean
Okay. Would you envision that the increase in expenses due to increased promotion and investment would be greater or less than the increased revenues as a result of the increased promotion.
Shawn Patrick O'Brien
Good question I think pretty close, I think right now they’re almost aligned. I can say that our expectation of the investment in the remainder of 2015 is not a double-digit millions of dollars in increase.
And then as I’ve said previously in modeling our company I think it’s right to model the company growth based on our revenue stream from the royalty and then the growing Canadian portfolio or seeing great growth peers in Canada and now we can tuck-in Vaniqa and launched Actikerall by the year end. And then in addition the Innocutis now the commercial infrastructure that we have in place in the portfolio with seven products and then launching Pruridexin and Dermadexin hopefully it’s the 510(k) process goes away - in United States we would be looking to launch those in the first quarter of next year.
So I hope that’s helpful for you David.
David Dean
It is. Thank you very much, that’s all for me.
Operator
Your next question comes from Jason Napodano with Zacks. Please go ahead.
Jason Napodano
Good morning, everyone.
Shawn Patrick O'Brien
Good morning, Jason. How are you?
Jason Napodano
I am doing well; you guys are certainly been very busy. So congrats on all the deals and congrats on executing very well in the first quarter while you are still doing a lot of business development so well done.
Let me just ask about the size of the portfolio now is obviously I mean this is a completely different company then it was six months ago, you've got 31 territories in the U.S. I think you have six or seven sales reps in Canada.
Maybe you could just give us a sense of what’s the ideal number of territories or reps in the U.S. given all the products that you've acquired same question for Canada.
And then obviously when you've got a rep out there detailing a product it’s nice to have a flagship product that they can go out and really get into the door with. And then it's nice for them to have some secondary products and some secondary detailing products and some sampling products.
But when I look at one sales rep potentially carrying around 10 products this doesn't make sense. So maybe you can give us a sense of not only the size of the sales force that you plan on creating, but specifically the number of products that each rep may carry where they'll be promoting those products and just how you intend to kind of manage this huge portfolio now that you have?
Shawn Patrick O'Brien
Okay, Jason. And I’ll answer in strategic terms at the top and then ask Joe and Joan to highlight specifically relevant to Canada.
But I mean the bottom line principles for me on a marketing and sales orientation is to make sure we have the right share of voice for the products in the market it serves and may bring an understanding that our message is getting through to the right customer with the right level intensity and frequency to drive profitable growth. So in general terms you see in the United States fully matured dermatology sales forces between 55 to 75 range and then some companies will go to multiples on the long-term.
And then the other aspect is what products are focused for active to that promotion and what products are in the portfolios that we don't plan to invest in from a rep effort, but also – but we plan to perhaps maintain our relationship with the customer and the value that product brings to certain customers to non-rep promotions. So that’s just from a – the overall view my experience in Canada with specialty sales forces have been that multiple of 16 reps in Canada allows good geographic penetration and concept to the U.S.
being at 50 to 75. So Joe.
Joe Pecora
Hey, Jason. Couple of things, first of all just to give a round number I think Shawn is in the area that most of the targets would be anywhere to 50 to 75, right now with our 31 territories we are calling approximately I’m going to say 3,500 key physicians if you magnify that out to where 60 would take us probably about 6,500 key targets.
And what we do is we target largely dermatology written out by about 80% of our call plan is against dermatology, 15% is with podiatry and then we have a very small amount of high-volume prescribers that we would be touching in primary care that do a lot of dermatology type of products. We will basically promote overall about four products, but the representative wouldn’t be walking into a physician's office promoting all four.
In the U.S. we have targeting data which allows us by market segment to prioritize for our rep, first physician, second physician and now what we call third or tertiary sampling physician with each of our target.
So the order may change, but in general terms our first product physician would be Sitavig, second would be Nuvail and third would be supportive products in our legacy whether it’s [indiscernible] or what have you. And that can change for an example with podiatry where you would walk in with Nuvail being in primary physician.
So we use our call plan in order to determine it, the goal as Shawn said that with the right target, right message, right number of times.
Joan Chypyha
Thank you, Joe. In Canada we have seven reps currently and with the two new products we get excellent coverage right now with seven reps.
We see our results gradually adding representatives probably two to four in the next 12 months as we had Beteflam in some of the other future products to our portfolio. We are able to cover about 1,200 physicians with the current seven reps that we have we chose adequate coverage for the three products that we have in the bank.
Shawn Patrick O'Brien
Is that helpful Jason.
Jason Napodano
Yes, that is very helpful. Let me ask you a question about Epuris in Canada, in the press release now it’s obviously sales were up 139%, but RX was up 162% and I am wondering if the difference there is an inventory thing or price coming down I mean what is the reason why RX would be up higher than the reported sales?
Peter Weiler
Hi, Jason I can answer that one so we report our revenue based upon product shipments as opposed to RX there can be a disconnect as inventory get bounced in the system?
Jason Napodano
Okay, all right it makes sense.
Peter Weiler
That number really matches on a quarter-by-quarter basis.
Jason Napodano
Gotcha. Okay last question maybe this one is probably for you Norm, just in terms of the R&D costs going forward it doesn't look like you have a lot of expense if any on CF-101.
But if you move ASF-1096 in the Phase III there will be some cost associated with that I assume you got some R&D costs associated with Nanolipolee. Can you just give us a sense on the you know the R&D spend maybe for the year or maybe kind of looking forward just on some of these programs?
Shawn Patrick O'Brien
Jason its Shawn I will answer that question, R&D right now the budgeted number that we’re working with is about $2 million which roughly $0.5 million and half allocated to Nanolipolee-007 to finish the formulation work, get the formulation delivering what we need in the profile the product and then finishing the pre-IND work, so that we can submit that in 2016 and moving the clinic in 2016. In addition to the 1096, adding to the budget on our R&D based on meeting with the FDA if we are successful in achieving the same outcome that we have achieved with the European authorities i.e.
that the clinical plan that the EU is willing to accept to get the product approval and in addition to get orphan drug status this is about $10 million program to deliver this product to the market was quite attractive for a product that has potential over $200 million in sales. So that that program will be move forward after we have our FDA meeting to ensure that we have agreed and align plan between Europe and U.S.
to commercialize this brand. If we can achieve that is obviously going to be more expensive program in line with the U.S.
Jason Napodano
Can you just - I am sorry I might have missed when that meeting is scheduled for…
Shawn Patrick O'Brien
So it’s not scheduled right now the number one and two priority is we’re submitting Pruridexin and Dermadexin by June and moving that forward and the next priority is to get 1096 in a program - in the Phase II discussion with the FDA and we are just putting that package together, so we’re ready for that meeting.
Jason Napodano
Gotcha. Thanks for taking my questions guys.
I appreciate it.
Operator
Your next question comes from Joe Walewicz with LBS. Please go ahead.
Joseph Walewicz
Yes, good morning gentlemen. Most of my questions have been answer but I just wanted to just clarify a few things first on the Almirall products you'll be taking I mean Vaniqa is already on the market, Actikerall you will be launching shortly do I have all that correct?
And then in terms of the revenue base, I think Vaniqa was pretty modest up to now, but I just want to understand you know what you think those products might do Vaniqa is going to sort of fit in the bag and you’re going to milk that or do you think you can grow that business or is Actikerall the key product there. And then on the Astion products just I think you’re talking about early 2016 for launching in the U.S.
just want to clarify Canada is a similar timeline and that would be great? Thanks.
Shawn Patrick O'Brien
Okay, Joe I’ll let Joan answer those questions because she had great experience in Vaniqa so, Joan.
Joan Chypyha
Hi, Joe. As you mentioned we expect to launch Vaniqa actually start selling Vaniqa by the beginning of June, it’s been unpromotive for about a year now.
So there is been a bit of decline. So we expect to keep it – we expect to see some modest growth and improvement over the next year.
Between these two products we expect to see between $3 million and $4 million in growth over the next five years and Actikerall we are expecting on the market is relating to the fourth quarter of this year. Sorry, second part of your question.
Joseph Walewicz
Yes, Dermadexin and Astion products for Canada.
Joan Chypyha
The Astion products in Canada will be submit to The Natural Health Products Directorate and we expect to do that in the next six months.
Joseph Walewicz
Okay, so this will be NPM in Canada.
Joan Chypyha
Yes, it will be.
Joseph Walewicz
Yes, okay. Great, thanks.
Operator
[Operator Instructions] Your next question comes from Douglas Loe with Euro Pacific. Please go ahead.
Douglas Loe
Yes, thanks very much and good morning all. Congratulations on the quarter.
Two questions for me. Shawn, if I missed this I apologize, but I just wonder if you can provide an update on Absorica regulatory and filing and marketing status in the non-North American markets, recall that filing in Brazil was to be imminent and launch in Chile was equally imminent and perhaps other rest of world markets were also been targeting your strategy.
So just an update there, I apologize if I missed it earlier. And then second of all was just wanted to drill down a little bit on CF-101 if you don't mind I mean you reported last month that 32-week data from Can-Fite's main study was certainly more positive than 12-week data was, but world that is increasingly dominated by interleukin targeted anti-bodies that have pretty solid 12-week data, just wonder if you could talk me through what existing for CF-101 would be in the psoriasis market and what is an increasingly competitive market that targeted by Novartis, J&J and others.
And I’ll leave it there, thanks.
Shawn Patrick O'Brien
Thanks, Doug. Peter is joining us on the call today.
So I’ll let Peter answer both those questions on where we’re on our strategy for Absorica outside of North America and as well as why we feel confident that is a real opportunity for CF-101 in Canada.
Peter Weiler
Hi, Doug. Looking at North America timelines for a launch of Absorica in Latin America, we’re still expecting an imminent launch in Chile when the final stages of that regulatory review process, so buying any unforeseen circumstances we expect that it should be on the market likely in Q3.
Regarding Brazil, we’re continuing to work with our partners Sun now [indiscernible] to get that product submitted, there has been some discussions regarding the rate of requirements that the Brazilian Health Authority called and [Visa] is requesting and so we’re just looking to I guess to clarify or to better delineate the exactly what those filing requirements are so the latest essence that we have would be likely our first half 2017 launch again for any foreseen circumstances though of course that’s always subject to change. Turning to the CF-101 product also we can’t comment on the data beyond what Can-Fite has issued in the press release other than to say that we were very encouraged by the full analysis of the longer-term data as when we saw the initial press release the 12 weeks the interim data did not show a great separation at 12 weeks the real value is in kind of 16 to 20-week period.
So, certainly within the full dataset, the data was very encouraging. In terms of its position in the market you are obviously correct that you are seeing some fantastic results with some of the IL-17 and IL-23 compound.
That being said those products are reserved for patients who have the most severe forms of psoriasis and of course they are extremely expensive, so managed care is not available necessarily for all of those patients. So there is still a very large population that has more moderate psoriasis for which that with the powerful biologic drugs which have some very nasty side effects potentially are simply not indicated.
So that moderate psoriasis population is actually quite large and the way that treatment algorithms currently work is that most physicians would prefer to use an oral compound that acacias without the side effect profile of a biologic and we expect that CF-101 was still that niche. So it has very prudent efficacy without the side effect profile or challenges of methotrexate.
So we expect to step into that kind of moderate psoriasis market and compete very well with methotrexate and we are very encouraged both on the psoriasis front and on the regulatory authorities front.
Douglas Loe
That’s very helpful. Thanks very much.
Shawn Patrick O'Brien
Yes, Doug I think in summary just to say that we think there is a pricing positioning between the methotrexate in the biologic and there is also a patient profile in between those two therapies of choice on the spectrum for use in the patients with psoriasis. So we are very confident, we can communicate the benefit and penetrate the market with those compound assuming the data continues to hold and deliverable what you’ve seen so far.
Douglas Loe
That’s awesome. Thanks very much.
End of Q&A
Operator
There are no further questions at this time. I will now turn the call back over to Mr.
O'Brien.
Shawn Patrick O'Brien
Thank you Jonathan and thanks again to everyone for joining us today, we look forward to speaking to you at a time when our second quarter results are presented in August. So enjoy the rest of your day.
Operator
Ladies and gentlemen this concludes today's conference call. You may now disconnect.