Titan Pharmaceuticals, Inc.

Titan Pharmaceuticals, Inc.

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Biotechnology

Titan Pharmaceuticals, Inc. (TTNP) Q3 2012 Earnings Call Transcript

Published at 2012-11-13 17:59:02
Executives
Sunil Bhonsle – President Marc Rubin – Executive Chairman Kate Beebe – EVP, Chief Development Officer
Analysts
Jason Napodano – Zacks Elemer Pir – Burrill & Co Hank Beinstein – Gagnon Mark Cohen – Westside Investment Management
Operator
Thank you for holding, and welcome to the Titan Pharmaceuticals Third Quarter 2012 Financial Results Conference Call. At this time, all participants are in a listen-only mode. There will be a question-and-answer session following today’s remarks. Please be advised that this call is being taped at the company’s request and will be archived on the company’s website starting later today. At this time, I would like to turn the call over to Sunil Bhonsle, President of Titan Pharmaceuticals. Please go ahead.
Sunil Bhonsle
Thank you, Candice, and thank you all for joining us today. Welcome to the Titan Pharmaceuticals call to review financial and operational results for the third quarter of 2012. Before we begin, let me remind you that we filed our form 10-Q with the SEC and subsequently issued a press release on November 12, 2012, detailing our third quarter financial results. This press release can be found on our website at titanpharm.com. On the call today from Titan, we have Dr. Marc Rubin, our Executive Chairman; Dr. Kate Beebe, Executive Vice President and Chief Development Officer; and Brian Crowley, Vice President of Finance. Before we get into the details of the third quarter performance and an update on the company, I want to remind everyone, that certain matters we will discuss today, other than historical information, consists of forward-looking statements relating to, among other things, our expectations concerning our financial results, available cash, clinical programs, partnering arrangements and regulatory strategies. The forward-looking statements are not guarantees of future performance and are subject to a variety of risks and uncertainties that could cause actual results to differ materially from the results contemplated by the forward-looking statements. These risks and uncertainties are described in our Annual Report on Form 10-K filed with the SEC and subsequent SEC filings. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today. We undertake no obligation to update or revise the information provided in this call whether as a results of new information, future events, or circumstances or otherwise. Well, having said all that, let’s start with an overview from our Executive Chairman, Dr. Marc Rubin. Marc?
Marc Rubin
Thank you, Sunil, and hello to everybody. Thank you for joining us this morning or this afternoon, depending on where you’re located. The board has been very pleased with the excellent progress made by the Titan team, especially with the timely filing of the Probuphine NDA last month. This is a tremendous accomplishment for any company and especially important milestone for a small company like Titan. As you all may be aware, there has been an increasing recognition in the medical community and society overall of the growing opioid addiction epidemic. Buprenorphine an approved agent for the treatment of opioid dependence and drug used in our investigational Probuphine subdermal implant is currently available in the form of daily dose sublingual formulations and has reported annual sales last year of approximately $1.3 billion in U.S. Still there is an undeniable need for safe, effective, long-term treatment options that minimize or eliminate the risk of abuse diversion or accidental exposure. We believe that Probuphine has the potential to ensure compliance to treatment and also to offer a substantially decreased risk for diversion abuse and accidental exposure. This could mean an entirely new treatment option for opioid dependence. The board has also been closely monitoring the activities associated with potential strategic partnership for the commercialization of Probuphine. As you know, in September, we granted an exclusive option for the commercial rights to Probuphine for an investment entitling of $4.25 million at a substantial premium to the market price of our stock at the time, which represents a very significant commitment on the part of the potential licensee. That option extends through the end of the year and we are very encouraged by the resources in dollars and in committed expertise already allocated to the Probuphine program by the prospective licensee. We are all working expeditiously towards completing this transaction to further realize value for shareholders and to reach our ultimate goal of bringing Probuphine to the healthcare community. And with that, I will pass the call back to Sunil.
Sunil Bhonsle
Thank you, Marc. I want to provide you with our third quarter financial results next and will then turn the call over to Kate for discussion of our Probuphine and ProNeura development programs. And then to conclude, we will open up the call for your questions for the typing management team. So, let’s start with the financial results. Total revenues for the third quarter consisting of royalties on net sales of Fanapt were approximately $1.2 million, compared to about a $1 million for the comparable period in 2011. This royalty income will be paid by Titan to Deerfield in accordance with the terms of the agreements we entered in last year. Total operating expenses for the third quarter of 2012 were approximately $3.9 million, compared with approximately $3 million for the third quarter of 2011 and consisted largely of R&D expenses of about $3 million compared to about $2.2 million for the 2011 period. The increase in R&D costs was primarily associated with an increase in external R&D expenses. And this is result of the preparation of Probuphine manufacturing operations at the contract manufacturer and demonstration of commercial scale production capability, as well as the preparation of the NDA, which as Mark mentioned was submitted to the FDA in October. General and administrative expenses totaled approximately $0.9 million for the third quarter of this year compared to about point $0.7 million for the third quarter of 2011. The increase in G&A expenses is primarily related to small increases in legal fees, non-cash stock compensation costs, facilities and other administration costs which were partially offset by decreases in consulting and professional fees and travel costs. Net other expense for the 2012 third quarter was approximately $5.4 million compared to net other income of about $1.2 million in the comparable period in 2011. The 2012 period included approximately $3.7 million related to non-cash losses resulting from increases in the fair value of outstanding warrants and approximately $1.6 million of interest expense compared with approximately $2.4 million related to non-cash gains resulting from decreases in the fair value of outstanding warrants and about $1.2 million of interest expense, during the third quarter of 2011. Net loss applicable to common stock quarters, for the third quarter of 2012 was approximately $8 million, or about $0.12 per share, compared to a net loss of approximately $0.8 million or about $0.01 per share for the comparable period in 2011. Net loss for the nine months period ended September 30, 2012 was approximately $14.9 million or about $0.23 per share, compared to a net loss of approximately $12.3 million or about $0.21 per share for the comparable period in 2011. At September 30, 2012, Titan had cash and cash equivalents of approximately $5.1 million, compared to about $5.4 million at December 31, 2011. We also received about $3.9 million in October 2012 upon exercise of warrants, and we believe, that the working capital at September 30, 2012, along with the proceeds from these warrant exercises is sufficient to sustain our planned operations through March 2013, including a scheduled installment payment to Deerfield of about $2.5 million in early April 2013. As Marc also mentioned, this has been a quarter of significant progress for Titan. The new Probuphine manufacturing facility at the contract manufacturers was completed, and commercial scale manufacturing capability was demonstrated. This enabled us to complete our NDA for Probuphine, which was submitted to the FDA last month including request for priority review designation. If priority review is granted, the review process has the potential to be completed by early summer next year. These next few months will be very active for the Titan team as we prepare for the interaction with the FDA addressing any questions and preparing for inspections (inaudible) sites, contract manufacturing sites, testing sites, and at our offices. As Mark mentioned earlier, the potential licensee has devoted substantial resources to the Probuphine program already and is active in preparing for the possibility of a priority review timeline and completion of this process by early summer next year. This involves our activities in both the marketing and the supply chain functions to enable the team to get fully familiar with the product, its attributes and challenges. We are very encouraged by this interaction and look forward to concluding the transaction in the near future and to relationship in the long term. At the end of the call, Brian and I will be happy to address any questions you may have about the financial results for the quarter. I will now turn the call over to Kate to provide an update on the Probuphine program, our NDA submission and to briefly touch upon our preclinical ProNeura program. Kate?
Kate Beebe
Thank you, Sunil, and thanks to all of you joining us today. As we previously announced, Probuphine NDA was submitted electronically on October 28, 2012. Our submission is currently under initial review and we expect to learn at the FDAs filling determination including whether the requested priority review is being granted by early 2013. The priority review request was based upon feedback from the FDA at our pre-NDA meeting. Our priority designation is given to therapies that offer major advances and treatment including improved safety or provide a treatment where adequate therapy exists. If priority review is granted the FDA action date on our NDA will be set at six months as opposed to the standard 10 months. Throughout the review process, we’ll continue to work firstly with the FDA to address their questions, and to facilitate the medical non-clinical pharmacologic and chemistry manufacturing and controls reviews as necessary. Now, in addition to submission related and commercial corporation activities, we continue to present the producing data at major medical conferences. Upcoming presentations and meetings this year include the American College of Neuropsychopharmacology or ACNP, at their annual meeting on December 05 in Hollywood, Florida and the American Academy of Addiction Psychiatry or the AAAP on December 08, in Aventura, Florida. But before turning the call back over to Sunil, I’d like to briefly highlight written progress in our ProNeura program. Probuphine is just the first product to utilize our proprietary long term drug delivery technology ProNeura, which has the potential to be used in developing products for the treatment of the other product conditions. Early in the third quarter, we announced that we had successfully completed a pre-clinical investigation into the feasibility of a long term, round the clock, non-fluctuating treatment for Parkinson’s disease with an approved dopamine agonist ropinirole or maintaining stable round the clock blood levels may benefit the patient and improve the medical outcomes. This pre-clinical study was primarily funded by a $495,000 grant awarded to Titan by the NIH under the SBIR program and administered by the National Institute of Neurological Disorders and Stroke. Patents for this indication have been granted in several countries and prosecution continues in the U.S. and other countries as well. This is an exciting development that we will further evaluate with experts in the field and we’ll continue to provide you with updates as appropriate. Now, back to Sunil and your questions. Sunil?
Sunil Bhonsle
Thanks Kate. Candice, we are now ready to take questions from the call participants.
Operator
Thank you. (Operator Instructions). And we’ll take our first question from Jason Napodano from Zacks. Jason Napodano – Zacks: Good morning everyone.
Sunil Bhonsle
Good morning, Jason.
Kate Beebe
Hi, Jason. Jason Napodano – Zacks: Question with respect to the timing here. If I add 60 days to the filing I get December 28. If I add 74 days I get January 11, so am I understanding it correctly that if you get priority review we’ll hear on the 28, but if it’s a regular review we’ll hear more around the first week or so of January?
Sunil Bhonsle
Jason, in this setting certainly the calculation of December 28th or January 11 kind of fetch the 60 day and 74 days. Unfortunately, the December 28th is right at the end of the year. So, I wouldn’t necessarily put anything specific as that date, but certainly within that timeframe we expect to hear back on the acceptance of our NDA and the status of the review in terms of priority review or regular review, within that timeframe when you’ll hear it. Jason Napodano – Zacks: Okay. As far as the exclusivity talks that were extended till December 31st, I guess I am curious as to why you would go with December 31st, knowing that the acceptance of it came on the 28th, the priority view on the 28th, 29th, or 30th, fantastic, but like you said, given the holidays and given that’s the end of the year, you may not have an FDA acceptance until the first week of January, but you’ve got an exclusivity period that ends December 31st. So, can you just kind of point that up a little bit for me?
Sunil Bhonsle
Sure, Jason. I mean I think as we have indicated in the past as well, the exclusivity period was requested specifically to accomplish certain tasks within the company that really have nothing to do directly with when the NDA was submitted or the priority review designation or when the acceptance will occur and that is still the case. So the December 31st date was really associated with things that the company has to do internally and not really associated with the NDA review process. Jason Napodano – Zacks: Okay. I read in your filing, the internal, I think you said internal structural review that the company was near – a structural path that the company was doing. I’m not going to ask you what those are, I know you’re not going to answer that question, but just knowing what we all know about this industry and that things typically tend to take longer than they are expected, especially when you’re talking about either restructuring or we can all speculate on what that means, but if you’re talking about restructuring or a spin-off or whatever, those things tend to take longer than anticipated. So, what gives you guys confidence or what gives a perspective partner confidence that they’re going to have everything that they need done by that time period.
Sunil Bhonsle
During this period, obviously, we are in contact with them and continue to participate in various activities along with them. That’s what gives us the confidence that this is going to be completed in a timely fashion because we are obviously seeing progress that we feel is very important.
Marc Rubin
Hey, Jason, this is Marc. While we can’t give you a specific date, we firmly expect that this is going to be consummated significantly before December 31. Jason Napodano – Zacks: Okay, okay, that’s interesting. Now, you’re in exclusivity talks, I mean I’m just going to assume this is for the U.S., can you give us a sense on whether or not those talks also include the potential licensing for chronic pain indications and then also whether or not those talks are including the territories outside the U.S.?
Sunil Bhonsle
I don’t want to get into specific details, Jason, since we have not yet and amounts the details around the transaction itself. So, I won’t go into that. However, I will make the point that clearly Probuphine is a product that is usable in both addiction and in treating chronic pain. Of course, we would need to do clinical development in the chronic pain area. It’s not something that is separable in a way that would allow possibly different licensing and so on. So, keeping that in mind, these are indeed both indications that are important and go hand-in-hand. Jason Napodano – Zacks: Okay. So, you would consider them to be important to you guys, I guess we will figure out whether or not? This is also – it will be something that the partner takes forward?
Sunil Bhonsle
Well, once we have concluded the transaction, obviously we will provide all the details and you will then know all the details. Jason Napodano – Zacks: Okay. Two more questions. Can you give us a sense, the REMS that were submitted with the application, how you go – how you went about the process of preparing that REMS and maybe you could even compare it a little bit to the REMS for Suboxone or other long acting opioids?
Kate Beebe
Jason, this is Kate. A very good question. And, I can tell you that the first – the starting point for preparing that REMS was the very good explicit guidance that we received from the FDA, during the our Pre-NDA meeting last October on 2011. They gave us very good instructions, told us what they did not want to see in the REMS, or they didn’t want to see in the REMS, as you can imagine, because it’s for the same indication of opioid dependents using the same drug substance buprenorphine, there are many similarities between our REMS and the Suboxone Film realms. However, because we have a very unique implantable long-term delivery system where diversion and misuse issues are potentially mitigated. Our REMS has a different focus and I can’t give you many more details about that because it’s not public yet and of course we’ve submitted our proposed REMS to the division for their review. We will be discussing it with them and finalizing it with them in the near future. So, that’s about all I can tell you in terms of details about the REMS. Jason Napodano – Zacks: Okay. Just one final question. Any thoughts on record discontinuing sales of the sublingual tablet?
Kate Beebe
Well. That was a surprise to all of us within the medical and scientific community and I imagined that they have myriad of reasons for pursuing that pathway. It’s unfortunate and that it limits access to care for patients that need it and I really don’t have many details other than what’s been made public by that company. Jason Napodano – Zacks: Okay. It seems like that – as an analyst I can opine that they’re doing it to probably drive more use of their film, but it seems like it would then create a void in the market that you guys could penetrate?
Kate Beebe
Well, we certainly hope so and we’re very focused right now on getting the NDA approved and if we’re fortunate to get the priority review getting our product on the market as soon as possible so that we can’t fill that void as you very rightly noted. Jason Napodano – Zacks: Thanks for answering the questions guys. Congrats on filing the application.
Kate Beebe
Thanks Jason.
Sunil Bhonsle
Thank you. Jason Napodano – Zacks: Thank you, Katherine.
Operator
And we’ll take our next question from Elemer Piros from Burrill & Co. Elemer Pir – Burrill & Co: Yes. Good morning. Good afternoon.
Sunil Bhonsle
Hi, Elemer.
Marc Rubin
Hello. Elemer Pir – Burrill & Co: Hi. Certainly if you could just reconcile one numerical item for me please and let’s get this out of the way I think in an 8-K you disclose that $4.9 million were raised from warrant exercises, yet the press release today say that it’s 3.9. The way I reconcile is that the extra million may have coming in September, am I correct or would you help me with this please?
Sunil Bhonsle
Yeah, I know you’re absolutely right Elemer. Some of those warrants were exercised in September and so about a $1 million was included in the cash as of the end of the year and $3.9 million came in October. Elemer Pir – Burrill & Co: Okay.
Sunil Bhonsle
And by since the end of year, I mean the end of the quarter. Elemer Pir – Burrill & Co: Yes, yes. So, the existing cash, the $9 million take out $2.5 million, $6.5 million on that would last about two quarters as you anticipated in the press release. So, would you please help me to understand if you could help to reconcile how it be divided between the two quarters and what keeps the R&D component if that goes to R&D or the lion share to R&D keeps it relatively high after the NDA submission?
Sunil Bhonsle
Sure. Not quickly. I think in terms of numbers the guidance that we provided in the past, if you look at just Titan and none of the R&D related clinical or so on expenses our burn rate kind of runs around $7 million, $7.5 million a year. And so, if you think of it in that manner – the two quarters would represent just under $4 million or so of the total expense. I just maintaining the company and moving forward with all the programs. Now, the R&D component right now – there are number of things that happen once you file the NDA. Obviously, one part has to do with the commercial manufacturing side of things which has to do with the validation and the process making sure that you are set by the time the inspections occur that all of the things have been completed. So, there is expenses associated with that that we will incur and of course we are operating on a timeframe as if this would be a priority review which means we have to prepare over the next two, three months to anticipate an expert panel and to make sure that we are fully prepared to answer questions. At the same time, getting ready for what maybe in the final labeling, so there’s a number of expert consultants and so on that we will continue to utilize during this period to support both the NDA review process as well as prepare for a possibility of advisory meetings for instance, all of these things have to be done and done in a very rapid fashion and that’s where some of the money goes, that’s where we actually plan. Bulk of it is in the manufacturing and validation side but there’s also a component of it within supporting the NDA. Elemer Pir – Burrill & Co: Okay. Thank you. This is a weird question and I apologize for it, but you’re describing this hypothetical partner that it’s made of very significant commitment to the program already even without signing the agreement, both stock – on other activity, if you just could guesstimate, how much they already spent on market research preparing for launch, et cetera, et cetera, is it tenths of thousands of dollars, perhaps over a million, what would be your best guess be?
Sunil Bhonsle
I don’t want to get into specific numbers that have been pointing out to you that, as Mark mentioned, it involves people that have been signs of there as substantial team that is working on this and that and obviously translates into substantial expenses. And, external activities including bringing experts to help how to setup for launch and so on for this product. So, these are commitments, which are quite significant – I’m not going to get into numbers. Elemer Pir – Burrill & Co: Sure. Do you have any plans to core market along with the partner or you would plan to leave it completely up to them?
Sunil Bhonsle
I know everyone would like to know more details including you, (inaudible) and I’d love to provide it, but at this time as we’ve said in the past, our focus has been on finding the right commercial partner who can provide the resources and make certain that this product gets the best in a launch and future marketing that it deserves. Our strengths are in the development area, and we’ve not built on top of that yet. So, with that sort of being our strategy and that’s what we will continue to push forward with. Elemer Pir – Burrill & Co: Okay. And, if I may just have a couple of brief questions to Kate. Kate – do I remember correctly that the second phase III trial is still pending in terms of publishing?
Kate Beebe
Yeah, it’s been submitted. It’s currently under review. We’re hoping to here soon, but Elemer, we do present – we have presented those data at international and national conferences. Elemer Pir – Burrill & Co: Yes.
Kate Beebe
For example, International Society of Addiction Medicine with October in Geneva, will be presenting at the ACMP meeting and at the AAAP meeting, and there are some meetings planned for next year that we haven’t finalized yet, but we’ve submitted abstracts for those meetings and we continue to do the medical and scientific communications to keep full throttle. Elemer Pir – Burrill & Co: Okay. Thank you. Kate, also the training that would be part of this marketing effort, how long would it take to train a physician who hasn’t done incisions for a while to learn the procedure?
Kate Beebe
That’s a very good question. We anticipate that the training module will be conducted in two to three hour workshop format, done locally. And to be qualified to do this procedure, they need to have done some small surgical procedures in the relatively recent past and have some facility with that medically. To some day if you haven’t done surgery in 20 or 30 years may not be the ideal candidate for doing the procedure. That being said, we’re in the process of developing the training for the commercial scale training program on and I hope to be able to provide additional details about that perhaps on our next call. Elemer Pir – Burrill & Co: Okay. Thank you. And the last item, in your previous survey that you conducted. Did you ask a question that what percent were – that are a survey tradition would not be interested in learning about this procedure? Was there any expressions or did you get any feedback that...
Sunil Bhonsle
Yeah, we..... Elemer Pir – Burrill & Co: That would indicated that? Yeah.
Sunil Bhonsle
I would say that, we didn’t exquisitely ask that question in our market research, but just – sort of anecdotally, I can tell you that the medical conferences that I have been attending for the past couple of years have been interesting and then I’m approached by a wide variety of physicians, who are interested in obtaining the training. So, you know certainly, it will be a segment of the prescribing base, not all prescribers will want to do the procedure, but we are going to put a process in place that will assist those subscribers who don’t want to do the procedure with assistance to find another clinician who can be immediately located, who can do the procedure for inserting and removing Probuphine for those patients. Elemer Pir – Burrill & Co: I see. Thank you very much for answering all of my questions.
Sunil Bhonsle
Sure, Elemer. Thank you very much.
Marc Rubin
Thanks, Elemer.
Operator
(Operator Instructions) And, we’ll take our next question from Hank Beinstein from Gagnon. Caller, please go ahead and please check your mute function. Mr. Beinstein, please check your mute function. Hank Beinstein – Gagnon: Okay, can you hear me now?
Sunil Bhonsle
Yes. Hank Beinstein – Gagnon: Hi, sorry about that, I’m using cell phone and it’s a little awkward. I want to congratulate to getting your NDA file on the cutoff gain and I wanted to reinforce or at least reconfirm what you reconfirm to the statement Mark made a few minutes that basically you’re expecting the transaction with your potential partner, if you will to be consummated significantly before December 31st, I heard that correctly?
Sunil Bhonsle
That’s correct. Again, we can’t give you a specific date, but we do expect that it will happen significantly before the end of the year, right. Hank Beinstein – Gagnon: That’s good to hear. My real question is for Dr. Beebe and there has nothing to do with Probuphine, it has to do with Parkinson’s. I’d like to know what the next trial would consist of and just specifically if you – the size of the trial and if you have any plans to open this up to people who are suffering with Parkinson’s disease.
Sunil Bhonsle
Hey, that is a great question and of course we’re very excited about this possibility having only just completed one pre-clinical study. Our R&D strategy any advancement of that particular indication moving forward. It’s still an estimation to see very early stages and largely it’s going to be determined by our strategic partnership. At this point, I really can’t get you many more details, but I can tell you it is a very high priority for us. We’re excited about it, as well as other potential opportunities for developing the primary technology. Hank Beinstein – Gagnon: When you say your strategic partner, is that the same partner that you’re contemplating doing the transaction currently or is it a different partner?
Sunil Bhonsle
I think in this setting the – what Kate was implying is obviously the resources that you need to support a program like Parkinson’s development and I’ve got to make sure that we have all of the resources in place before we move forward too much farther with it. And in the program itself in this setting, it’ll have still possibilities as we mentioned and the next step for us is really to have the experts to discuss this and wet it out in terms of how best we move it quickly into the clinical setting. And those are sort of the next steps over the next few months that Kate is planning which I’m sure in the next call and so on we can elaborate further as we build on the program. Hank Beinstein – Gagnon: That’s great. Well, thank you very much and again congratulations on the filing.
Sunil Bhonsle
Thanks Mike.
Kate Beebe
Thanks Mike.
Operator
(Operator Instructions) And we’ll take our next question from Mark Cohen with Westside Investment Management. Mark Cohen – Westside Investment Management: Hi good morning everybody.
Sunil Bhonsle
Hi Mark, how are you?
Kate Beebe
Hi, Mark. Mark Cohen – Westside Investment Management: Well, thanks. Wanted to know if you consummate the transaction with your partner before December 31, will you be disclosing at that point in time who the partner is?
Sunil Bhonsle
Absolutely and the details of the transaction certainly. Mark Cohen – Westside Investment Management: Okay and just – I can guess but do you know what the reticence is, is having their name known at the moment?
Sunil Bhonsle
What I don’t know about the word reticence necessarily but what I want to point out is till the actual transaction is executed. We can’t – it’s inappropriate really to get and talk about the details sort of the company or anything like that, because it just would be premature.
Marc Rubin
Yeah. Just this is standard in any deal. Before the deal is consummated, specifics of the deal just aren’t given out including the name and it really doesn’t reflect Radisson on their part as just standard operating procedure so to speak. Hank Beinstein – Gagnon: Okay. All right. And then, next question, when you have the clinical trials with Spermine, were you able to use any information from most clinical trials and how you’re approaching, what you’re trying to do with the current clinical trials or the current product for Parkinson’s?
Marc Rubin
Some of the things that were done with Spermine in the non-clinical setting, obviously, are very similar to what would be done with this type of a test and the product as well. When you get into the clinical side, it’s a very different process and procedure and the patient population is something will have to look and decide, which one fits best in the setting. Both Kate and Marc are probably far more conversing to this area, but that’s generally the direction in that was need to really establish what patient population to look at, that would best be served by a product like Probuphine and it was quite like different from Spermine. Hank Beinstein – Gagnon: No, I understand that, Probuphine, just from a clinical standpoint, but from an information standpoint, you clearly have data in the area of topic that you’re pursuing and I was just curious if you learned a lot from that experience, which you’re able to apply when you’re approaching that again?
Kate Beebe
Yeah, absolutely, Mark. We did learn a lot through conducting the Spheramine clinical development and non-clinical development and we’ll be applying this best practices moving forward and as we hopefully go into the clinic with the ProNeura delivery system Ropinirole, that’s something that is in the future and we don’t have a clear roadmap for that yet, but we absolutely will apply what we learned about the patient population, about the different clinical sites that we used and their expertise, about recruitment tactics, about patient retention tactics. All of these things are very important as we put our development plan together for this new indication. Hank Beinstein – Gagnon: Okay, great. Thank you very much.
Marc Rubin
Thank you very much, Cohen. Good talking to you.
Kate Beebe
Thanks Mark.
Operator
This concludes today’s question-and-answer session. I will now turn the call back over to Sunil Bhonsle for closing remarks.
Sunil Bhonsle
Thank you, Candice and thank you all for participating in this call. We remain very confident in our belief that Probuphine approved for marketing will be a transformative new treatment for opioid dependence and we truly appreciate your ongoing support. And just on a happy note for those of you who follow my faith, a Happy Diwali to you all. Thank you.
Operator
This does conclude today’s conference. Thank you for your participation.