Corium International's (CORI) CEO Peter Staple on Q1 2016 Results - Earnings Call Transcript

| About: Corium International, (CORI)

Corium International, Inc. (NASDAQ:CORI)

Q1 2016 Results Earnings Conference Call

February 08, 2016, 05:00 PM ET

Executives

Peter Staple - President and Chief Executive Officer

Robert Breuil - Chief Financial Officer

Analysts

Etzer Darout - Leerink Partners

Bill Tanner - Guggenheim Securities

Serge Belanger - Needham and Company

David Steinberg - Jefferies

Operator

Good day, ladies and gentlemen, and welcome to the Corium International's First Quarter 2016 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Later, we'll conduct a question-and-answer session, and instructions will be given at that time. [Operator Instructions] As a reminder, this conference is being recorded.

I would now like to hand the conference over to Robert Breuil, Chief Financial Officer. Please go ahead.

Robert Breuil

Thank you, Karen and good afternoon. We announced today, aftermarket closed, the financial results for our first quarter of fiscal 2016, the quarter that ended on December 31, 2015. The press release is available on the investor page of our website at www.coriumgroup.com.

Joining me today is Peter Staple, our President and Chief Executive Officer. Peter will begin with an overview of our business and product development programs. I will then discuss our financial results for the quarter. Our comments will then be followed by Q&A session.

During the course of today’s call, we may make a number of forward-looking statements, including comments on our business strategy, product pipeline, financing, clinical trial timing and plans, clinical and regulatory pathways for our development programs, the achievement of clinical and commercial milestones, partnering our co-development efforts, the advancement of our technologies and our proprietary co-developed and partnered products and product candidates, the competitive landscape for our products, trends in our revenues, the potential impacts of market consolidation, our ability to generate revenue growth, future operating expenses, our ability to manage our costs and other matters.

These forward-looking statements are based on assumptions that are subject to risks and uncertainties that could cause our actual results to differ significantly from those suggested by these statements. Given these risks and uncertainties, you should not place undue reliance on these forward-looking statements

Please refer to our Form 10-K filed with the Securities and Exchange Commission on December 16, 2015 for some of the important risk factors that could cause our actual results to differ materially from expectations, including any forward-looking statements made on this call. Except as required by law, we disclaim any obligation to publicly update or revise any forward-looking statements to account for or reflect events or circumstances that occur after this call.

I will now turn the call over to our President and CEO, Peter Staple. Peter?

Peter Staple

Thank you, Bubba, and welcome everyone to our call for the first fiscal quarter ended December 31, 2015. It was an especially productive quarter at Corium as we executed on our plans to develop a rich portfolio of innovative transdermal products based on Corium’s technology platforms.

I’d like to start with some highlights on our product programs, focussing in particular on our candidates in the central nervous system therapeutic area. Last week, we announced the positive topline results of our Phase 1 Pharmacokinetic or PK study of our Corplex Donepezil product candidate for Alzheimer's disease. This was a transdermal patch that is designed for sustained and controlled delivery, on a weekly basis of the drug Donepezil.

Donepezil is the active ingredient in Aricept, and was approved by the FDA for the treatment of mild, moderate and severe Alzheimer’s disease and is one of the leading treatments on the market for the disease. It is responsible for over 40% of the units sold in the U.S. market.

Donepezil is a leading acetylcholinesterase inhibitor and is generally prescribed during all phases of the progress of Alzheimer’s. It acts by increasing the concentration of acetylcholine, the chemical that is needed for effective neurotransmission and for any function.

Donepezil is currently available only in oral dosage forms which presents compliance challenges for family members and caregivers. You cannot rely on patients to consistently take their daily medications. In addition, the drug is known to cause gastrointestinal side effects, including nausea, vomiting and loss of appetite.

We believe that a multi [ph] day transdermal form has the potential to provide significant improvements in compliance, and to decrease the GI associated adverse events by bypassing the GI tract.

Although Donepezil is well known to be a very challenging drug to formulate for transdermal delivery, our R&D team at Corium has used our Corplex technology platform to address these challenges and to create a novel transdermal system.

Our Phase 1 pharmacokinetic study demonstrated that a Corplex Donepezil candidate through a sustained and control delivery over a seven day period with an acceptable skin tolerability profile. The PK profile and a statistical projections of the data indicate that Corplex Donepezil, and oral Aricept would provide a highly similar exposure to the drug get steady state. This is largely due to the long half life of Donepezil. The data also indicate that it may be possible to establish bioequivalence between our transdermal formulation and the oral dosage form which could avoid the need for a typical large and costly Phase 3 pivotal study.

On our Phase 1 results, we plan to request a meeting with the FDA to define the clinical regulatory path forward. We expect this meeting will take place within a few months likely in the second calendar quarter.

In the meantime, we are already working on optimizing the formulation of patch size for 10 milligram a day delivery of Donepezil in a once-weekly patch. And as a follow up to the initial PK studies, we’ll be conducting an additional short PK study starting in March to select an optimized product for further development. This is independent of the planning for the meeting with the FDA, but may provide supplemental information for advancing clinical development.

We are also preparing for the next steps in development taking into account that this will be guided by the FDA discussions. Our clinical results today suggest that a bioequivalent space path to registration may be available and that this may require pivotal study of approximately 110 to 150 subjects with about eight weeks of treatment.

This pivotal study would be appreciated by a small bioequivalence pilot study designed to confirm study size and PK sampling schedule. We expect this pilot study to begin dosing in the fourth calendar quarter. We look forward to providing you updates as this program progresses.

In addition to the Donepezil program, we have recently completed the treatments of subjects in the Corplex Memantine Phase 1 PK study, and we anticipate reporting results later in February on that study.

Memantine, the active ingredient in Namenda is the other major treatment in the market for Alzheimer’s and like Donepezil represents over 40% of the units sold in the U.S. for this indication. [Indiscernible] brain cells called NMDA receptors and this action blocks the activity of the neurotransmitter called glutamate that can over stimulate and kill nerve cells in Alzheimer's patient. The drug is indicated for moderate and severe Alzheimer’s disease and is typically added to an acetylcholinesterase inhibitor such as Donepezil.

It is only available in oral dosage form and also it has GI and other side effects, therefore there is a similar opportunity for improvement and therapy for the transdermal formulation that we discussed previously for Donepezil.

Like Donepezil, Memantine has a long half way about 60 to 80 hours. We initiated the Memantine Phase 1 PK study last fall; we recently completed the treatment and are in the process of data analysis. This study has a similar design and end points as the Donepezil trial and also has the potential like Donepezil to provide support for bioequivalence approach to clinical development.

Our Corplex Donepezil and Corplex Memantine program represents substantial new product opportunities in the Alzheimer's disease area. This is a field where the failure rate in clinical testing of new chemical entities is very high, very close to 100%. And our programs offered a potential for improved treatments based on existing, approved compounds.

The Corplex Donepezil and Memantine candidates represent a unique opportunity for Corium to create a franchise of products to support treatment of neurodegenerative diseases and auto CNS conditions and we are excited about the advances we are making on these programs.

In another CNS-focused program we are working with a partner Aequus Pharmaceuticals. This product candidate is designed to deliver Aripiprazole, the active ingredient and ABILIFY in a once weekly patch.

Aripiprazole is indicated for treatment of a number of psychiatric disorders, including bipolar I disorder, schizophrenia, major depressive disorder and irritability associated with autistic disorder. It is one of the largest selling drugs in the world in the CNS therapeutic area. We work with Aequus on the formulation of this product as well as process development and manufacturer of clinical suppliers.

Last week, Aequus announced positive results from an initial bioavailability study of this transdermal aripiprazole product candidate supporting the feasibility of sustained seven day delivery with a well tolerated dosage. Aequus has indicated that the plans to follow up with a multi dose bioavailability study as we look forward to working with the Aequus team to advance the supported candidate.

In addition to the Corplex based CNS programs, we are also pursuing development of products using our MicroCor technology. This proprietary technology uses dissolving microstructures or microneedles for the safe, effective and convenient transdermal delivery of small molecules and biologics, including vaccines, peptides and proteins.

We are exploring potential partnering arrangements relating to our MicroCor PTH (1-34) program for which we obtained positive results in a Phase 2a study. This product candidate would be a therapeutic alternative to Forteo, which requires a daily injection of parathyroid hormone. We are discussing potential collaborations around this opportunity with a perspective development and co-developments partners.

The PTH results provided additional validation of the MicroCor platform and we are working with partners on incorporating a variety of proprietary large molecules into MicroCor at the preclinical stage.

As we’ve discussed previously, we are also conducting feasibility evaluations of the use of microcorporate transdermal delivery of certain small molecule drugs, in particular, where rapid delivery and fast onset of activity can provide improved therapeutic benefit.

As we noted in our press release earlier today, we’ve seen positive results in vivo testing of a MicroCor transdermal system for a delivery of zolmitriptan. This is the active ingredient in ZOMIG, a leading treatment for migraine headaches, very fast onset of quick relief is an important in the acute migraine field and in our studies in predictive pig models the MicroCor system achieved maximum concentration over ten times faster than oral ZOMIG and in a timeframe similar to other migraine therapeutics that require needle projections. With these promising results, we are evaluating formulation approaches that can enable us to advance into clinical proof of concept studies later this year.

Beyond these exciting new proprietary product opportunities, we are continuing to support our base business of developing and manufacturing products for partners. As we have noted in our calls of the past, this business tends to grow and expand based on the introduction of new products into the mix.

With respect to the existing market of products, we have seen that our revenues from the Fentanyl economy products which are generics have declined historically as our partners have faced increasing competition. We also have some uncertainty relating to the status of the quantity and product due to our partner Teva’s pending acquisition of the generic business of Allergan and potential requirements for divestitures and associated transitions.

We are currently focussed on growing the value of this business with new products that we developed with our partners. I have mentioned the Aequus program a few minutes ago, which is an example of a newer program with a significant commercial opportunity. We have other programs at various stages of development and have the potential to provide more growth in our partnered product business. The most advanced of these is the Twirla once-weekly contraceptive patch, which is in a Phase 3 confirmatory clinical study.

Our partner, Agile therapeutics is closely managing the study which is fully enrolled and anticipates completion this fall. This is an innovative product that has the potential to substantially increase our manufacturing product revenues and to sustain revenue growth over many years.

To summarize, we have made important advances in our complex based CNS programs and our MicroCor programs and are developing new products with our partners. As we achieve clinical milestones for our programs, we’ll have the opportunity to actively manage our portfolio so we can ensure we place our resources and our priorities where they can provide us the most benefit and value.

We are fortunate to have many possible product opportunities and we may have even more as we go forward, but we realize that pursing all of them completely in parallel may not be the best path forward. We also realize that the current equity market environment is not an attractive one for raising money and we plan to manage our product programs and our partner relationships to make the best use for our financial and other resources.

I’d like to now turn the call over to Bubba Breuil, who will review our financial results. Bubba?

Robert Breuil

Thank you Peter. As a reminder, today we will be discussing results for the first quarter of our fiscal year. Our fiscal year ends September 30, 2016 so the first quarter ended December 31, 2015. From this point forward, I will simply use the word year to refer to our fiscal year and 2015 and 2016 to refer to our two most recent fiscal years.

Today, we reported total revenues of $7.5 million for the first quarter, compared with $9.8 million in the first quarter of 2015. Product revenues for the quarter were $6 million, compared with $6.5 million in the first quarter of 2015. The decrease in product revenues was primarily due to the declines in revenues from our fentanyl products.

In July 2015, we amended our agreement with Par Pharmaceutical, our marketing partner for fentanyl. To eliminate the royalty owed to us on this product in exchange for other rights and modified transfer pricing. While these changes have had the effect of reducing our gross profit margin on the products, unit volumes appear to have begun to stabilize after a sustained period of declines.

Partially offsetting this reduction in fentanyl revenues, revenues from clonidine were up modestly this quarter. Our sales to Procter & Gamble were down modestly during the quarter which we believe is the timing issue. For the full year, we expect our P&G revenues to grow.

Contract, research and development revenues were $1.3 million for the quarter, compared with $2.9 million in the first quarter of 2015. The decline in R&D revenues was primarily the result of several programs that were in the later stages of development this quarter which corresponds to lower development activities and associated revenues. We also earned certain development milestones in the first quarter of fiscal 2015, but none were due this quarter.

We have limited visibility into how our partners will market and price our products; a similar uncertainty applies to contract R&D revenues from programs that are in earlier stages of development but less for later stage programs.

As company consolidation continues in the generic drug industry, we face additional uncertainties with regard to potential divestitures of both products and R&D programs. These uncertainties include the timing of such transitions, the disposition of excess inventories by the divesting parties, new pricing and the bundling and discounting policies of the acquiring parties, as well as decisions as to whether or not to continue development programs that are already underway.

Teva is our marketing partner for clonidine is also the sponsor of additional development programs that are either underway at Corium or under review at the FDA. So any divestitures arising from Teva’s contemplated acquisition of Allergan’s generic business which also includes the competing clonidine patch could have a significant impact on our revenues or their timing in 2016.

Turning to R&D expense, I'd like to discuss our results in terms of total R&D expense, which is the sum of the R&D expenses for our proprietary programs and the cost of contract R&D revenues for our partnered program. As investment in our own pipeline continues to accelerate and as we have begun to engage in co-funding opportunities with certain development programs, we think it is most relevant to look at our total R&D investment.

Total research and development expenses in the quarter were $7.5 million, down slightly from $7.9 million for the first quarter of 2015. This increase was driven largely by the transition of several programs into later stages of development including the completion of the Phase 2a trial for our PTH program in July 2015 as well as the termination of a co-development program partially offset by the initiation of Phase I trials for our Donepezil and Memantine CNS program both of which started at the end of the 2015 fiscal year. As we advanced our proprietary programs into later stage of clinical development, we expect our R&D expenses to increase.

General and administrative expenses for the quarter were $3 million, compared with $2.7 million in the first quarter of 2015. The increase is primarily related to the addition of staff in the second half of 2015 and an increase in stock based compensation expense primarily related to the issuance of new stock options.

As we continue to phase in for SOX compliance and continue to expand our business and corporate development efforts in parallel with our product pipeline, we expect G&A expenses will continue to increase.

Net loss for the year was $9.4 million, or $0.42 per share, based on $22.2 million weighted average common shares outstanding during the quarter. This compares to a net loss of $6.8 million, or $0.37 per share, based on having only $18.1 million weighted-average common shares outstanding in the first quarter of 2015. The significant difference in the weighted average number of shares between the first quarters of 2015 and 2016 arises from our follow on offering into August 2015 in which we issued 4 million new shares.

We ended the quarter with cash and cash equivalents of $63 million compared to $72.2 million at the end of the fourth fiscal quarter of 2015.

Now, I will turn the call back over to Peter. Peter?

Peter Staple

Thank you, Bubba. To summarize today’s discussion, we’ve made important advances in building our portfolio of Corplex based CNS product candidates particularly in Alzheimer’s disease with our recent Aripiprazole final results and our Corplex Memantine results coming soon. We are pursuing MicroCor applications as well and have seen positive results in predictive animal studies on rapid delivery of migraine treatment.

As our development partners are advancing including the Phase 3 study being conducted by Agile on its contraceptive patch and the recent bioavailability study results and the Aequus programs. We are enthusiastic about the opportunities in front of us to create new, high value products and leverage our two proprietary technology platforms and our expertise in developing new transdermal products.

With the progress we have made, we are well positioned to realize these opportunities and we look forward to reporting on more important milestones in 2016.

Operator, we can now open the call for questions.

Question-and-Answer Session

Operator

Thank you. [Operator Instruction] Our first question comes from the line of Jason Gerberry from Leerink Partners. Your line is now open.

Etzer Darout

Hi, how are you? This is Etzer filling in for Jason today. Had a couple of quick question. First, wonder if you could provide a little bit of update or maybe a little bit more color on the cash front for the year and perhaps a bit on the cash runway as you continue to execute on these and your current programs.

And the second question is, wondered if you could talk about the timing of the Aripiprazole patch, multi dose study in conversations you know with Aequus and anything else you could provide in terms of timeline would be helpful. Thanks.

Peter Staple

Okay, on the Aripiprazole multi dose study they have indicated that they plan to start that this year. I think they have indicated in the first half of the year.

Robert Breuil

I guess, I’ll handle the cash question. You will have noticed that we burned almost exactly $9 million in each of the last two quarters. That was with two phase 1 studies in parallel in the clinic. So I think it’s best to look at that is our baseline burn if you will without taking into account Phase 2 or BE study expenses.

So as we get clarity on what our regulatory path forward is with the FDA and whether or not it will include both Donepezil and Memantine at the same time, I think you’d have to add those burns for the incremental cost of the phase 2 to that.

Etzer Darout

Okay. Thank you.

Operator

Thank you. And our next question comes from the line of Bill Tanner from Guggenheim Securities.

Bill Tanner

Thanks for taking the questions. So Peter just back on the Donepezil patch, so basically it’s going to come down to the -- that you need, that the company is going to need to have a 5 mg or a 10 mg drug containing patch and that’s going to have to show bioequivalence to the tablet, right its not that you could have a different amount of drug in the patch and you just and then you could show bioequivalence to orally 5 mg or 10 mg.

Peter Staple

Yes, Bill the issue is not how much drug is in the patch, but how much is delivered. The objective is to deliver and had blood concentrations are equivalent and we are targeting the 10 mg as the most important dose from a commercial perspective. We’d expect ultimately that we could have both the 5 mg and a 10 mg per day of patch but that’s the amount that gets delivered as opposed to the amount that’s lowered [ph] into the patch.

Bill Tanner

Okay, so then as it relates to -- okay so just take a number maybe its 15mg of Donepezil and the patch to give coverage that’s comparable to 10 mgs or let’s -- is that correct?

Peter Staple

Correct.

Bill Tanner

And so then is that when someone I guess and prescribing it how is that actually described to the physician that this patch its I guess is less relevant, how much drug is in the patch and it’s more relevant as it relates to how much is delivered. Is that complicated or?

Peter Staple

No, it’s not Bill because the dosing the labelling is based on milligrams per day delivery. That’s common to patches, patches come in sizes and they are labelled with the amount of drug they deliver over the prescribed time period, so it would be typically a 5 mg per day patch worth 10 mg per day patch, the amount that’s loaded in the patch is not the relevant part of that.

Bill Tanner

Okay. And then you made a comment in the prepared remarks about the size, I mean is that then principally the lever that would be pulled I guess to try to -- should be able to super impose your PK curb on oral Donepezil. Just trying to figure out how many degrees of freedom you have to get there to try to get this right?

Peter Staple

While there is good proportionality both with the oral and the patch dosage form, so it’s fairly straight forward to when you know the level, the concentrations [ph] you are achieving with the initial patch to make an adjustment to get a proportional dosing. We also have an opportunity in the study we are getting prepared to start to do some fine tuning around the specific formulation and the size so that we are prepared for the next phase of result.

Bill Tanner

Okay. And then maybe the last question. You don’t -- you know certainly don’t want to jinx anybody, but in the event that you are unable to formulate it in a manner that would be -- would likely go down the BE path, is that -- would you contemplate then just during the regular clinical studies or move onto something else, do you have an idea on that?

Peter Staple

Well first of all the study that we have just completed and announced the results of -- are the basis for the FDA meeting on the potential for bioequivalence and we have achieved results that we think support that, we obviously have to make that, I’d like to have a discussion with the FDA.

The additional work that we are doing is more to prepare for the next stage of development. But if I take your questions on a step if whatever reason based on the data that we have the FDA suggest that we need to go to the full safety, efficacy, phase 2, phase 3 round, we would prepare for that atleast two a piece would actually be small PK phase 2 studies. Somewhat or two in the pilot PK study that we spoke about the other day, a phase 3 would be a more expensive study that would be -- would take along the period of time.

Bill Tanner

Got it. Okay. All right, thanks very much.

Operator

Thank you. [Operator Instructions] Our next question comes from the line of Serge Belanger from Needham and Company.

Serge Belanger

Hi, good afternoon. First a question on the Memantine patch, you mentioned in the prepared remarks that the Phase I study was very similar to the Donepezil 1, just trying to get an idea of which doses you are looking at for the Memantine patch and should we expect that the next steps will kind of mirror the same ones as for Donepezil such as optimization an additional Phase I PK work?

Peter Staple

Yes, with Serge, with the Memantine study, we were targeting the 28 milligram of Memantine which is a higher dose of Memantine. And that -- otherwise this is a very similar study design to what we talked with Donepezil.

Serge Belanger

Okay. And then, remind me again with the partnership with Aequus. You have the option to increase your, I guess, level of collaboration or partnership for on the ABILIFY patch. Just wanted to know, I guess, what are the trigger points to increase that?

And I think in your press release from last week, they also mentioned they were developing two additional patches; one for epilepsy and I think one for nausea, vomiting in pregnancy. Is the Corium technology also targets those additional two patches?

Peter Staple

So Serge, our collaboration with Aequus is one that allows for adding new programs into it based on discussion between the parties. And so, we certainly have an opportunity to include those programs in that. On aripiprazole the collaboration initially is one that is being funded by Aequus. We have helped them with the formulation of the products and so there is a supply relationship and a development relationship and a economic participation in the program that is commensurate or our contribution.

We also do have an opportunities adjusted to become a co-development partner with them and that’s something that we’ll be looking at for the near future that would essentially allow us to have a larger stake in the program by co-investing in the program with them.

Serge Belanger

Okay. And I guess just a modeling question for Bubba. We saw a contract research revenue stake take a bump down this quarter, should we expect the following quarters to kind of mirror this new level?

Robert Breuil

Yes, I’ll take that. One reason that bumped down is we had milestones earned in the year prior, so those come in at very in frequent or certainly not every quarter basis, so looking ahead to next quarter, I think that that’s a fair statement. But as Peter mentioned in his comments and I reiterated, we have to sort out what’s going on with Teva before we can really get beyond the current quarter in terms of forecast.

Serge Belanger

Okay. Thank you.

Operator

Thank you. And our next question comes from the line of David Steinberg from Jefferies.

David Steinberg

Thanks. Good afternoon, gentlemen. Couple of questions. And the first, you mentioned the uncertainty of clonidine. Theoretically if it goes to Teva, and it has to get divested and for whatever reason and being zero let’s just say, could you help us with the run rate for fentanyl and the Crest Whitestrips, so we can -- that will help us for their modeling?

Peter Staple

Let me start and then Bubba can give the second part of it. The reason for divestiture is to ensure that there is continued competition, so if there is a divestiture, it would be in the context of ensuring there are some continued competition. So going to zero is an unlikely situation, but I’ll let Bubba talk about the other products.

Robert Breuil

Yes, and kind of building on that, you may recall we’ve been through this once before where Aequus was our fentanyl partner and then they’ve divested the product Par. And in that transition the way inventory gets handled, the way White [ph] gets handled, all that can vary differently.

So, second what Peter said, just because of the divestiture there is very little risk of zero. However, there is a risk for one quarter to look unusually or unusually small, that’s the part we don’t know yet. As for fentanyl, go ahead David.

David Steinberg

No. You can continue. Thanks.

Peter Staple

Sure. For fentanyl, as I mentioned in my comments, this product has had a very crowded marketplace. We’ve seen the unit volumes going down steadily, but now we’ve seen the unit volume start to stabilize out. We also saw last year we had a different commercial relationship with Par and we’ve renegotiated that in a win-win, but part of what that means is that the revenues for that are because there is no royalty anymore, the gross profits going to be a little lower. But I think what you said, model is stabilization from based on what we’re seeing this quarter.

But, with P&G, we expect those revenues to grow, whether they grow -- as we’ve always said all along, whether they growth enough to offset the declines in fentanyl and clonidine remains to the same. But we did launch a new product last year. We’re always working on new products for them, so I think that would be your key when you see us announce a new product launch. That would be the key to model it up.

David Steinberg

I fully understand it unlikely they go to zero, but there may be some volatility in those revenues. Just curious if you can answer the question, what percent of gross profit or what percent of revenue the other two products, what that run rate roughly would be?

Robert Breuil

Well, seeing from our case [ph] they’re not really a third to third to third, but what it’s hard to see from that is that the overhead absorption. We think all three products are equally important in terms of their overhead absorption. So, I would just think of that three as equally important in terms of what they contribute to the base business.

David Steinberg

Okay.

Robert Breuil

And as Peter pointed out many times, sorry, they in a way subsidize we get an entire full scale manufacturing plant that we get to run our product through at totally marginal cost.

David Steinberg

Right. Fully understand. So PTH you’ve indicated that you’re not going to see through on your own, I would imagine that cost of developing will be prohibited, but you have mentioned on a couple of calls now that you’re in discussion, just curious if you can give us a little more color on those discussions. Are they early stage or they’re late stage, be it the term shade stage, is there something that you fully expect you’ll have completed by end of this year?

Peter Staple

David, that’s difficult to predict. As you know any business development discussion you’re not at the end until you’re at the end. So, I would to say, we’re in discussions, there are parties who are interested in the products and they have a questions for us and we have usual process that we’ll go through answering their questions and identifying where the opportunity is, what it could look to like. So, we don’t really have any specifics to talk about at this point and I think we’ll wait till we have something specific before we can disclose it.

David Steinberg

Okay. Last question [Indiscernible] what’s the latest on that product, could it reach market this year?

Peter Staple

That one we are working with our partner Teva on and with the FDA, it’s waiting for approval. We don’t know whether that could have some -- if there could some effect of the merger on that as well. So, that’s the primary source of uncertainly around that one. But assuming all goes well, we should be able to get it on the market.

David Steinberg

Okay. Many thanks.

Peter Staple

Thank you.

Robert Breuil

Thank you.

Operator

Thank you. And that’s concludes our question and answer session for today. I would like to turn the conference back over to Corium management for any additional comments.

Peter Staple

Thanks everyone for joining us this afternoon. And I want to thank our shareholders for their support and our employees for all their hard work and innovation. We look forward to seeing those of you who are planning to attend the LEERINK Partners this Annual Global Healthcare Conference in New York later this week.

Operator, would you please conclude the conference call.

Operator

Thank you. Ladies and gentlemen, thank you for participating in today’s conference. This does conclude the program and you may now disconnect. Everyone have a good day.

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