Titan Pharmaceuticals Inc (TTNP) 2011 Q3 法說會逐字稿

Welcome to the Titan Pharmaceuticals third quarter of 2011 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'd like to turn the conference over to Sunil Bhonsle, President of Titan Pharmaceuticals. Please go ahead.

Thank you, Lisa, and thank you all for joining us. And good morning, good afternoon, wherever you are. Welcome to the Titan Pharmaceuticals call to review financial and operational results for the third quarter of 2011.

Before we begin, let me remind you that we issued two press releases earlier this week, one detailing our third-quarter financial results, and one announcing our $15 million royalty sale agreement with Deerfield Management. Both press releases can be found on our website at www.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, our 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, 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 result of new information, future events or circumstances, or otherwise.

Well having said all that, let's start. I would like to turn over the call to our Executive Chairman, Dr. Marc Rubin, for his overview. Marc?

Thank you, Sunil, and hello everybody and thank you for joining us today.

This has certainly been a productive quarter and an important year for Titan. Last time we spoke, we were able to provide you with the detailed analysis of additional findings from our positive confirmatory Phase III study of Probuphine. Needless to say, we were extremely pleased with the statistically significant, and most importantly, clinically meaningful results of that trial, and grateful to the investigators and patients for their participation.

Since that time, one of the most important milestones for Titan has been the completion of the pre-NDA meeting on October 25th. Having participated myself in many meetings with the FDA over the past 20 years, including pre-NDA meetings, I was very pleased by the active participation of the FDA and the clear guidance they provided for completing the development of Probuphine. The FDA addressed all the questions we had included in the briefing document, and provided a clear path towards completion and submission of the New Drug Application. There is work to be done, but I believe this progress brings us another very important step closer to achieving our goal, making Probuphine available as a medication to treat opioid addiction.

Another important milestone is the recent transaction with Deerfield that provides the Company with money to fund our near-term activities. This is a unique transaction. We sold future royalty revenue from Fanapt in exchange for cash up front, a reduction in debt, which will improve our balance sheet; and a restructuring of payments that delays any principal payments by one year, and allows us to focus spending next year on product development rather than debt repayment. Importantly, there were no additional shares or warrants involved in this transaction, so the Board is very pleased with this outcome. We appreciate the ongoing support from Deerfield, a leading healthcare investor, and their confidence in Titan.

As a next step forward, our focus remains on advancing our ongoing discussions aimed at establishing a strategic partnership for the potential commercialization of Probuphine, and ultimately bringing a novel treatment for opioid dependence to patients and physicians. We are continuing to work with the teams at Woodside Capital Partners and Keelin Reeds Partners in all aspects of the business development activities, and have been impressed and encouraged by their work and our potential partners' response to the Probuphine program. This is a very exciting time for Titan, and we look forward to keeping all of you updated on our progress.

And with that, I will now pass the call back to Sunil.

Thank you, Marc.

Today, to get started, I will provide you with our third-quarter financial results, including an overview of our royalty sale agreement with Deerfield, and will then turn the call over to Kate for discussion of our Phase III program and the recent FDA pre-NDA meeting. To conclude, we will open up the call for your questions that the Titan management team can address.

So let's start with the financial results. Total revenues for the third quarter were approximately $1 million, consisting of $973,000 in royalties on net sales of Fanapt, and $39,000 in grant revenues from the NIH in support of the Phase III clinical study of Probuphine, and the SBIR grant for Titan's proprietary ProNeura drug technology. Total operating expenses for the third quarter were approximately $3 million, compared with about $3.7 million for the third quarter of 2010. The year-over-year decrease in expenses resulted primarily from a decrease of about $0.8 million in research and development expense, due to the reduced expenditure associated with the recently-completed confirmatory Phase III clinical study of Probuphine.

Net other income for the three-month period ended September 30th was approximately $1.2 million, compared to an expense of approximately $0.2 million in the comparable period in 2010. The increase in net other income during the quarter was primarily related to a $2.4 million non-cash gain resulting from a decrease in the fair value of the stock warrants issued to Deerfield Management, and this was offset in part by interest expense of approximately $1.2 million on the Deerfield loans. Net loss for the third quarter of 2011 was approximately $0.8 million, or $0.01 a share, compared with a net loss of approximately $0.4 million or a $0.01 per share for the third quarter of 2010.

As you know, on November 14, 2011, Titan entered into agreements with Deerfield Management, pursuant to which we sold a substantial portion of the balance of our Fanapt royalty stream to Deerfield in exchange for $5 million in cash, a $10 million reduction in the principal amount we owe to Deerfield under our existing facility agreement, and a revised debt pre-payment schedule of four equal annual payments with the first payment delayed by a year to April 2013. Following the closing of the transaction, Deerfield is entitled to the balance of Titan's portion of the royalties on Fanapt, up to a threshold level of net sales of Fanapt, and then 40% of the royalties above the threshold level. That threshold level begins at $17 million in 2012, peaks at $126.5 million in 2016, and ends with $46 million in 2017, the year Fanapt comes off patent in the US.

Year-by-year, threshold net sales numbers have been provided in the press release that we issued, and you can certainly look those up. Importantly, Titan retains 60% of the royalties on net sales of Fanapt above the threshold levels, subject to an agreement that half of any such retained royalties will go towards repayment of our outstanding debt to Deerfield. As Marc mentioned earlier, this transaction provides us with cash now, improves our balance sheet, delays debt repayment, and accomplishes this without issuing additional shares or warrants. Funding for this royalty sales agreement is expected to occur on or about November 30, 2011, and together with the $2.8 million cash on hand, this agreement is expected to provide sufficient cash resources to enable Titan to fund its operations into late second quarter of 2012.

With these funds in place to support the activities for completing Probuphine development and NDA preparation, we are focused on advancing our ongoing business development discussions, and working with Woodside Capital Partners and Keelin Reeds to help us establish a strategic partnership that builds shareholder value and rapidly advances Probuphine to the marketplace. We are currently at the stage in the partnering process where several companies are engaged in detailed due diligence. As you can imagine, this is an involved process, requiring frequent meetings and ongoing dialogue with multiple departments within these companies. There is a large amount of material to review, including data from five Phase III studies, all the manufacturing and product development data, non-clinical studies, the full regulatory history, and the market research studies that provide information valuable for commercialization of such a product.

I am very encouraged by the interest shown by these companies, and we are now going through the details of the pre-NDA meeting with the appropriate people. Once we have received the final FDA minutes, we expect these will confirm the activities we have planned, and provide clarity to potential partners on the path forward and potential timing of commercialization. We will certainly keep you informed of our progress in this important milestone for Titan. At the end of the call, Brian and I will be happy to address any questions on the financial results of this third quarter, or about the Deerfield transaction as well.

I will now turn the call over to Kate, to provide an update on the clinical development program and a brief summary of our recent pre-NDA meeting with the FDA. Kate?

Thank you Sunil, and thanks to all of you joining us today.

As you may know, in July and August of this year, Titan announced positive top-line results for our Phase III confirmatory study of Probuphine for the treatment of opioid dependence, as well as additional positive results demonstrating significant overall patient improvement, a very good safety profile, and the non-inferiority to the approved drug, Suboxone.

Last month, Dr. Walter Ling, who is Professor of Psychiatry and the Director of the Integrated Substance Abuse programs at the David Geffen School of Medicine in UCLA, and who is also a Principal Investigator in our overall Probuphine program, and I attended the American Society of Addiction Medicine, or ASAM, state of the art course in Addiction Medicine in Washington, DC. And there, Dr. Ling gave a presentation titled Probuphine and Other Agents To Treat Prescription Drug Abuse, which was very well-received by the approximately 300 or so conference attendees. Next month I will be attending the American Academy of Addiction Psychiatry meeting in Scottsdale, Arizona on December 8th; and there, I've been invited to present our Phase III trial findings in a symposium which is sponsored and chaired by the National Institute on Drug Abuse, or NIDA.

In terms of additional clinical trial updates, our Phase III, six-months open label study for the re-treatment of patients who earlier completed the controlled confirmatory study is progressing as planned, and is expected to be completed before the end of this year. In that study, more than 80% of patients who completed the original confirmatory study consented to receive the three treatments. And ultimately, 85 patients were treated with Probuphine in the study; and to date, the safety data are highly consistent with what we've seen in previous Probuphine trials, indicating, again that this treatment is very well-tolerated by patients. Full results of this trial, including pharmacokinetic and patient satisfaction outcome data will be available in early 2012, and I really look forward to reporting those data to you at that time.

On the regulatory front, in October of this year, we also announced an update from our pre-New Drug Application -- NDA -- meeting with the FDA, regarding the development of Probuphine for the treatment of opioid dependence. Prior to this meeting, we submitted a comprehensive briefing document with information on the non-clinical, the clinical, and manufacturing development of Probuphine; and we asked several questions of the FDA to help guide us with respect to what the contents of the NDA should be. Three days prior to that meeting with the FDA, they provided us with written responses to the questions in the briefing document, along with several pages of reference material and other comments. And upon review of these responses by the Titan team, we selected those items that required further clarification, and the meeting with the FDA then focused on these items.

We've not received the final meeting minutes from the FDA as yet. This normally takes about 30 days after the meeting. So today, I can only provide an overview of the meeting. But based on our discussion with the FDA, we believe that the Phase III clinical program completed to date is acceptable to support submission of an NDA, and that no additional clinical efficacy or safety studies are required to support this submission. We received initial comments from the FDA regarding manufacturing and non-clinical information, and while the overall manufacturing scale-up plan appeared appropriate to the FDA, there are certain items that need ongoing discussion with the Agency to confirm these requirements. We also received clear guidance from the FDA on their requirements for submitting an NDA for consideration to be designated as a priority review.

Now, ultimately our goal is to deliver a safe and effective treatment option for patients with opioid dependence, and these clinical and regulatory advances continue to move us forward towards that goal.

Now, I'd like to turn the call back over to Sunil, and I would be happy to address your questions. Sunil?

Thank you, Kate. At this time, Lisa, we are now ready to take questions from the call participants.

Thank you, sir.

(Operator Instructions)

Our first question comes from Jason Napodano, Zacks.

On the Deerfield transaction, the principal repayments that start in April 2013 -- is there an interest rate that's associated with those payments, repayments?

The interest on the original loan, as you know, Jason, was 8.5%, and that continues on the remaining principal balance, which after concluding this transaction, the principal balance will be down to $10 million. Of course, there are interest payments that will be made quarterly, and then the principal payments on an annual basis.

And as far as what Deerfield is entitled to in the future, are they entitled to any portion of a deal on Probuphine?

No, there is nothing related to Probuphine that is part specifically of this transaction. Just as a note, as we have said previously, the facility with Deerfield is a secured facility, so obviously assets of Titan secure that note. But other than that, there is no specific thing or Probuphine that's associated with it.

But you have the option to repay all of the debt early if you do get a deal and you have significant cash?

Absolutely.

Moving on to the 811 re-treatment program, can you give me a sense of why a patient -- I'm going to come at it from both directions -- but why a patient, number one, would seek to enroll in the open-label program? Is it because they feel they haven't kicked their habit essentially after the first six months, or is there additional counseling or pharma support groups that are associated with the trial that would entice someone to enter? And then, coming at it from the opposite reason, why would someone not choose to enroll in the open-label program?

Jason, this is Kate.

Very good questions. And I'll take the first one by saying that opioid addiction is a chronic relapsing type of disease, and most patients are going to require very long-term treatment, much like any other type of medical disorder like asthma or heart disease, or any other psychiatric disorder. Long-term treatment is the name of the game here, and so patients are seeking to enroll in the open-label re-treatment trial because they liked the treatment that they received in the first six months, and they want to receive further treatment.

Now, the reason why a patient may not choose to enroll in the open-label re-treatment and have more treatment is a variety of reasons. Sometimes there are personal reasons -- they don't want to engage in a clinical trial anymore; they've got a job; they're doing other things with their life. And that's largely the reason why patients don't want to enroll. As I said before, the majority of them do elect, if they are eligible, more than 80% of them do want to go and have additional treatment.

Do you know what the average length of a Suboxone course of treatment is, in terms of months?

There are a lot of different reports out there about how long patients stay in treatment with Suboxone. What the clinicians will tell you, and you may recall on our last conference call, Drs. Walter Ling and Dr. Rick Rosenthal, who are Principal Lead Investigators in our program, would speak to this as well; but patients on Suboxone treatment on average receive treatment for anywhere from 30 days to a number of months.

Sometimes they stop treatment prematurely for a variety of reasons, and then they re-engage; and this has to do with the pattern of relapsing and remission that I talked about earlier. Optimally, patients will be in treatment for probably several years in order to really reduce their level overall of illicit drug use -- and it's not just I'll illicit opioid use, although that's the main focus of treatment, but it's overall return to normal functioning in their life.

The priority review that you've discussed with the FDA -- was that something that you asked of them, or did they volunteer that information?

Jason, yes, in our questions in the briefing document, we asked of them whether we would have the ability to file under a priority review type of fast-track designation and so on. And so they were addressing that, and providing us guidance that would allow a drug like Probuphine to be considered, and in this setting, their guidance was very appropriate. They wanted to make sure that we understood that the importance of something like this is more geared towards the safety to the society of utilizing opiate medications; and that in this setting, that's the focus that we should explore.

As you know, we believe this certainly provides the ability to limit diversion of drug today, and so on, potentially. There's been reports -- I'm sure all of you heard of reports about death of children because of potential misuse of drugs. These are all very important things that have to be looked at, and we hope that we can show strong arguments that provide our product the ability to be considered for priority review. And that's the stage.

Thanks for the update.

Next up we'll take a question from Elemer Piros, Rodman.

Some housekeeping items out of the way first.

Sunil, the debt has been reduced by $10 million, and there is still $10 million outstanding. Am I correct there?

That is correct.

So then the combined cash that you had on hand and the additional $5 million, if you divide your -- and you mentioned that this might be sufficient until the end of the second quarter of next year -- if you divide this total number by three, that would be your anticipated quarterly burn going into the remainder of 2012 as well? Or do we expect to have any changes, unless you bring in another program, et cetera?

You know, in general, in terms of the cash on hand, will take this basically through the late part of second quarter. Looking at the burn beyond that, will really depend, as you say, on what additional things are left to be done.

Let me put it in this manner. Once the NDA is prepared and filed, our typical burn for just the Company, as we've indicated previously, is about between $5 million and $6 million a year. So depending, really, on how much additional expenses are involved with the various activities associated either with Probuphine or with other programs that may come up, that's how it really flows. Does that give you sufficient guidance in there?

Yes. Very good. Thank you.

Once you receive the minutes from the FDA, do you think that you might have sufficient clarity on what to do, whether we are dealing with manufacturing items or other non-clinical items that you could perhaps project a timeline out?

Sure.

I mean, in terms of the clarity, I expect the minutes from the FDA, barring any surprises, will provide real good clarity; and in that sense we already have started looking at all of the work that needs to be done. And I hope that the FDA minutes will just confirm what we already know and are planning to do. The work, certainly from a manufacturing standpoint, as I think Kate also mentioned, is we have to scale up manufacturing. This is a typical work that goes on after completing the Phase III study, especially in small companies. Unlike large companies, where they may do it earlier, we have to wait until we have sufficient resources to devote to it, and that's what we're doing right now.

This scale-up work, and then some additional work that will need to be done in terms of information on the product itself, it's all in vitro type of work. So it's basically lab-associated work. I don't want to go into a lot more detail, but just wanted to tell you the kind of things that have to be done, and so the timing of it is not long time. It's essentially typical of what one would require for this, and in terms of general guidance on timing of completing and filing an NDA, I would look at that somewhere in the mid-year time frame. Once we see the minutes of the FDA, and as we get further into doing this work, we certainly will provide more guidance, but that's the time frame otherwise that would be appropriate.

So it's safe to assume that you have chosen a contract manufacturer, at which you're doing the scale-up work now, or that could still change?

No, we have chosen a contract manufacturer. It's the same one who we have done all of the clinical manufacturing, the product for clinical supply, experienced manufacturer. In the past, the company's -- the name is DPT Laboratories; they're based in San Antonio, Texas. They're a large contract manufacturer of several different types of products for the healthcare industry.

Sunil, you also mentioned that there is no further essentially petri dish type of work is required in the non-clinical items. This product is going to be in people for potentially for a longer period than the six months that would be indicated in the original label. What is the longest animal exposure data that you have? And did long-term safety come up as a question from the FDA or from you, whether you satisfied that component? And have you found reassuring answers from the FDA there?

I will not get into a lot of details on it, Elemer, just from a standpoint of -- some of this is obviously confidential and also competitive -- but I'll give you some general information and guidelines on what we have seen and done.

In terms of animal studies, we certainly looked at long-term safety. In this case, at least 12 months safety. We obviously have done a lot of the toxicology studies and so on to establish the safety of this drug before we went into human clinical trials. And all of that data was part of the data that was discussed and presented to the FDA as part of the briefing information.

In human clinical trials, of course, Kate already talked about re-treatment studies, so we have done studies for treating patients up to one year; and so have that safety data as well. Based upon all of this, and the FDA felt comfortable that we did not need to do additional safety data, nor additional clinical studies for safety were necessary at this time. So we believe that the information we have at this stage is sufficient to support multiple use of this product. Of course, there are some things that we will need to look at when you have to re-treat a patient in this same site that needed to be treated. But there are many sites on the body, so that doesn't come up that quickly as additional information.

That, hopefully, gives you enough guidance on that.

Very much so. One last very small question.

Does Deerfield have an equity stake in the Company at this stage, or do they have warrants?

They have warrants that we know of. If any of the Deerfield funds have acquired any shares of Titan, I am not aware of it.

Thanks for taking all my questions.

Up next we'll hear from Hank Feinstein, Gagnon.

Hi, Sunil and Marc, and Kate. Congratulations on a very complete presentation.

I wanted to again compliment you on arranging this financing. I think it was a strategic step that had to be taken so that the balance sheet is improved, and I think Deerfield is really looking toward warrants for their return on this transaction. But I did have a question for --

We appreciate that very much, Hank, thank you.

I did have a question for Dr. Beebe. And it's as follows -- were there any surprises during your pre-NDA meeting? And how would you characterize in a general sense the FDA's attitude toward the Probuphine submission?

Thanks for your good questions, Hank.

There were no surprises, I would say, during the pre-NDA meeting that we had with FDA. They are very cooperative and supportive of our program overall. I would say it was a collegial discussion that we had, and we were very pleased and encouraged coming out of that. That being said, as Sunil has very well described, we have a lot of work ahead of us, and we still don't have the FDA meeting minutes. Until we have those in front of us, we won't know with absolute certainty and precision if there's anything else that comes up, but I do not anticipate any surprises and there were certainly no surprises during the meeting itself.

Thank you for a very thorough and interesting presentation on the status of the trials.

Our next question today comes from Mark Cohen, Westside Investment Management.

Hello, everybody, and congratulations on continued success and progress.

Thank you very much. Appreciate it, and hopefully it's nice and sunny down South, too.

As best I can see, yes.

Question for you regarding the potential partnering arrangements or discussions that you've had to the extent that you can comment. From the standpoint of the prospective partners, do you get a sense that they're waiting for or would like to see the filing first, or the drug approval, before they really step up to the plate? And, from your perspective, do you feel that you would gain greater advantage by waiting until the filing or waiting for the drug to be approved to arrange the best possible partnership arrangement for the Company?

It's a great question, Mark. I'll try to answer it in some general terms, but try to be as specific as we can in this setting as well.

In terms of the discussions with potential partners, so far, obviously, the focus has been on the due diligence, which means dealing with a lot of the technical aspects of the information that's available and addressing a lot of the questions that come up in that manner. From that standpoint, I am very encouraged with the depth of questions and the understanding of this program that the partners are gaining in this process, and so I believe that is a very genuine, strong interest in understanding and learning every aspect of it. And as part of that, of course, the FDA meeting, the pre-NDA meeting, was very valuable, because that provides the clarity that the partners need to have in terms of commercialization.

The second part of your question, on what is the best time to do a partnership, and what's the most value that we can gain for the shareholders -- it's very important, it's one of those questions where, how much investment do you need to make, let's say, to have a product actually approved, versus what you give up by partnering earlier? I'll tell you, from our standpoint looking at this right now, there are two very important aspects that have to be considered.

One, of course, is the fact that this product, once we submit an NDA, has a good chance, let's say, of getting a priority review, which means approvals can be fairly quick. If that is indeed the case, then you want to make sure that a commercialization partner is well on-board and ready to commercialize and launch the product sooner rather than later. So you try to minimize the time after an approval to actually launch a product. That means it is important to have a commercialization partner now rather than later. And so you have to balance that against the value that you create.

The second part, just wanted to mention, is obviously the amount of money it takes to even put all of this together, including preparing NDAs and getting all of the information to create a commercialization plan, including launch and so on, which is what would be necessary if we were to actually wait to do this after approval to gain value for the product. That's a lot of money. And certainly we are still somewhat cautious on how much money we want to spend from what we have on hand. So with that in mind, our goal really is to try and get somebody on board before this product gets to the final approval stages, so that we can fully take into account the timing that will be necessary to prepare for a proper launch.

And do you feel that the potential partners would be willing l to go along with that sort of time frame?

We have indicated our goals, and certainly the partners have continued their active participation, and so I do believe that they understand that.

And have you seen any drop-off in interested parties in the last couple months as progress has been made?

In terms of the participation by partners, it's at different stages and different levels. Some have early on, after looking at this, said this doesn't fit strategically in their portfolios, and others have continued to dig further. I'm not going to comment specifically on any in the last two months, this or that, but that's generally the status.

And has there been a common concern, or a concern that's been voiced by anybody, that you would consider to be somewhat material or germane to the discussions?

Certainly there are questions that come up through the due diligence, and we have -- I believe we have been able to address those, certainly, to the satisfaction, hopefully, of the partners and their questions. And the FDA meeting, of course, and this whole clarity has been something that they've always sought. So now the next few months are really the key in these discussions.

Very good. I've got my fingers crossed and wish you continued success.

Next up is a private investor, [JT Tarbell].

Sunil, on the last conference call you stated that there were several potential partners in the nitty-gritty stages of discussions. Could you please explain your interpretation and definition of nitty-gritty stages.

To me, certainly the in-depth due diligence that is going on is what I was specifically referencing there. There's conference calls, there's meetings, there's digging into data.

And what stages would you say the nitty-gritty stages we're in on a scale of one to 10, one being the original discussions, 10 being a completed partnership?

JT, I don't know that I want to get into speculating within what you may think is one, 10, and so on. I want to point out that it is intense and digging into all of the documents, and these are literally thousands and thousands of pages.

I know you can't be really specific; but in general, how many companies would you say are you entertaining discussions with? One to five? Five to 10? 10 to 20?

Somewhere in the middle of the range, is certainly similar to what I think I mentioned at the last call.

Have these discussions progressed further along than the nitty-gritty stages.

They continue to advance. How about that? Okay?

That's great. Thank you very much.

All the language, Sunil, that's been used by Titan so far has been partners, strategic partners, or potential partners. Is there any interest or offers in a total buyout being entertained?

I think I have previously said this as well, when you look at Titan and what is the real value and assets within Titan that has value, it's Probuphine for us; and that's what we focus on and we try to enhance that value. Our approach to this -- when I say partnership, it has been one of, how do we best get Probuphine into the commercial space that we believe will allow the most value to be added to Titan. Now, when you think of what is the best transaction to get there, that becomes something that really the partner looks at, and says, what's the best transaction for them? Is that a true partnership in the sense of a licensing arrangement and so on, or an acquisition type of an arrangement? These are things that come -- from a Titan standpoint, we are focusing on what will add the most value. If that becomes one of the transactions, that means a sale of the asset and so on, we will certainly evaluate that, and review that as well. And the Board is fully amenable to looking at whichever type of transaction makes the most sense to add the most value. Okay?

Great. Thank you so much. I have no more questions. Congratulations on your Deerfield deal. I think that was a great deal. And thank you so much for not diluting the shares.

Ladies and gentlemen, that does conclude today's question-and-answer session. At this time, I would like to turn the call back to Mr. Sunil Bhonsle for additional or closing remarks.

Thank you, Lisa. And thank you very much, everybody, for participating in today's call.

This is an exciting and important time for Titan. The results from the positive studies of Probuphine, continued with the productive pre-NDA meeting with the FDA in October, has provided us a clear regulatory path forward. We are continuing to make progress towards completing the scale-up of manufacturing of Probuphine, and compiling the information needed for the preparation of our NDA. All of these advances are positioning us strongly in our ongoing partnership discussions, and we will continue to provide you with updates on our progress.

Thank you very much for joining us today, and have a great day.

Once again, ladies and gentlemen, that does conclude today's conference. Thank you all for your participation.