Sunil Bhonsle - President and Chief Executive Officer Marc Rubin - Executive Chairman Kate Beebe DeVarney - Executive Vice President and Chief Scientific Officer Dane Hallberg - Executive Vice President and Chief Commercial Officer Brian Crowley - Vice President, Finance Jennifer Kiernan - Investor Relations

Ben Haynor - Alliance Global Partners John Vandermosten - Zacks SCR

Thank you for holding. And welcome to the Titan Pharmaceuticals Third Quarter 2018 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 and CEO of Titan Pharmaceuticals. Please go ahead.

Thank you, Sean, and thank you all for joining us. Welcome to the Titan Pharmaceuticals call to review financial and operational results for the third quarter ended September 30, 2018, and to provide an update on our business. But before we begin, I wanted to inform you that we filed our quarterly report on Form 10-Q with the SEC today. And the press release also issued this afternoon, provides a summary of the results and can be found on our website at titanpharm.com. Joining me on the call today from Titan are Dr. Marc Rubin, our Executive Chairman; Dr. Kate Beebe DeVarney, our Executive Vice President and Chief Scientific Officer; Dane Hallberg, our recently appointed Executive Vice President and Chief Commercial Officer; and Brian Crowley, our Vice President of Finance. But before we go into the details of the financial results and provide an update on the company, Jennifer Kiernan will review the required cautions regarding forward-looking statements. Jennifer?

Thank you, Sunil. I want to remind everyone that certain matters that will be discussed today other than historical information may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our product development programs and any other statements that are not historical facts. Such statements involve risks and uncertainties that could negatively affect our business, operating results, financial conditions and stock price. Factors that could cause actual results to differ materially from management’s current expectations, include those risks and uncertainties relating to the commercialization of Probuphine; the regulatory approval process; the development, testing, production and marketing of our drug candidates; patent and intellectual property matters; and strategic agreements and relationships. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law. And now back to you, Sunil.

Thank you, Jennifer. Today we will start the call with an overview from our Executive Chairman; Dr. Rubin who will also introduce our Chief Commercial Officer, Dane Hallberg. Dane will discuss the progress on our Probuphine commercialization plans. And then Dr. Kate DeVarney, will provide an update on our Probuphine medical affairs and rents programs, regulatory activities and other product development activities. Brian Crowley will then summarize the financial results. And I will close with a brief recap before opening the call for your questions. So let's get started. Marc?

Thank you very much, Sunil. And hello, and welcome to all of you. The third quarter of 2018 was marked by a number of notable achievements related to our lead program Probuphine and also to our ProNeura platform technology with opportunities there to expand its application. So let me begin by mentioning a few of the highlights. First, early in September, we initiated a pilot program with the Nevada Center for Behavioral Health, that is designed to evaluate medication-assisted treatment or MAT programs using Probuphine to treat Opioid Use Disorder or OUD patients who are within the State of Nevada criminal justice system. Then later in September, we were very pleased to announce that we were awarded a 2-year, $6.7 million grant, from the national Institute on Drug Abuse or NIDA. We also strengthened our balance sheet by closing an underwritten public offering, which together with the subsequent exercises of the overallotment option and warrants sold in the offering, provided us with net proceeds of about $12 million, which extends our runway through the third quarter of 2019. Those are all notable accomplishments, and my colleagues will elaborate on each in a few minutes. But today, I want to focus my comments on our activities supporting the commercialization of Probuphine in the U.S., because this is Titan's top priority. Our goal is to complete the transition to a commercial stage enterprise by the end of 2018. And to that end, in the third quarter, we have started by building a very strong foundation for our commercial infrastructure. This includes establishment of sales, marketing and market access teams. And leading this initiative is Dane Hallberg, who, I'm very pleased to say, was recently appointed to the position of Executive Vice President and Chief Commercial Officer. Dane has over two decades of healthcare experience, including commercial leadership roles with Able Star, Sunovion Pharmaceuticals, Global Healthcare Japan, Dendrite Japan, Tierra Incorporated, and also Merck, where he was a key member of the team that was responsible for launching the Implanon subdermal implant contraceptive among other products. Most recently Dane was retained by Bristol-Myers Squibb to provide strategic guidance and project management oversight for its global research and development, business intelligence and analytics and also health economics and outcomes research programs. Dane brings the Titan important experience and depth of knowledge and an impressive track record in sales and marketing and product launches and market access. He has been highly successful in building our commercial capabilities, leading marketing and sales teams and cultivating strong thought leader relationships across multiple specialties, in both the global pharmaceutical and biotech industries. So goes without saying, but I will say it any way that we are extremely fortunate to have Dane joined Titan's executive team in this key role at this very important time for the company. And with that, I will turn the call over to Dane to discuss our activities supporting Probuphine's commercialization. Dane?

Thank you very much, Marc. I'm excited to join Titan in this new role. In addition to being confident in Titan's ability to successfully re-launch Probuphine, I am optimistic that Probuphine has the potential to address some of the significant unmet needs in the global opioid use disorder epidemic. Titan's focus during the third quarter was largely on transitioning Probuphine's commercialization activities with minimal interruption, if any. The key activities included the transfer of supply chain and logistics functions and maintaining market access. I'm happy to report that during the third quarter, we identified opportunities to engage and provide better service for healthcare providers and patients in the long term, while continuing to supply Probuphine to prescribing healthcare providers. As Marc mentioned, we have made rapid progress building a commercial team with expertise in sales, marketing, supply chain logistics, regulatory compliance, third-party payer and medical access. We've engaged a small, yet experienced and highly accomplished sales team, and their training is expected to be completed in the next coming weeks. We have a seasoned and proven team assisting us with managing not only supply chain and market access functions, but we've also engage consultants where appropriate, such as for the purpose of navigating the regulations of commercializing a controlled substance. We are very pleased to have been able to maintain continuity of delivery of Probuphine to REMs certified healthcare professionals and their patients, during the third quarter, generating meaningful revenue during this transition period. We are targeting selected market segments where Probuphine can provide meaningful benefit for patients allowing for sustained market penetration and sales growth. We are focusing on high Probuphine prescribing physicians with long-term recovery oriented treatment programs. We are proactively engaging third-party payers and contracting with the right specialty pharmacy partners to ensure broad patient access. In addition, our market access specialists are paving the way to facilitate the supply chain and improve the reimbursement process. We believe that in the longer-term, some of the top tier Probuphine providers may engage in investigator sponsored research that can potentially provide clinically meaningful data, some of which could help us assess the possibility for future label expansion. We will continue laying the groundwork in the criminal justice system, residential treatment facility and academic addiction program market segments. The pilot program, we recently initiated at the Nevada Center for Behavioral Health, reflects our strategy to enable treatments of OUD in the criminal justice system with the hopes of reducing recidivism. A product like Probuphine could become part of the incarceration program treatment regimen. Part of a parole program was part of drug course incarceration prevention efforts. The goal of this pilot program is to generate data that supports the use of Probuphine in this setting and help the criminal justice system deal with the growing opioid addiction epidemic. There are a large number of residential treatment facilities within the U.S. many of which do not use Medication Assisted Treatment or MAT with high rates of post-discharge relapse. The use of MAT, as part of the management of opioid use disorder, has been increasing and is expected to rise substantially in the near term. As such, we plan to establish alliances with a few large programs that use MAT and can integrate Probuphine as part of opioid use disorder treatment. Finally, we plan to form alliances with institutions that already have trained personnel and equipment for conducting small procedures and support their use of Probuphine as appropriate. In summary, we are building a strong team that will be the foundation of future growth with our near-term focus on healthcare providers currently prescribing Probuphine and supporting their increased utilization of the product in patients who are likely to benefit. That being said, we are also working on a number of initiatives to support complement these efforts, including identifying current providers who could act as advocates for Probuphine, developing an advocacy plan for key opinion leaders, and leveraging a Probuphine educational program. In this endeavor, we work hand-in-hand with our drug safety and compliance team. I will turn the call over to our Chief Scientific Officer, Dr. Kate DeVarney, who will discuss Titan's progress on our medical affairs, drug safety and compliance functions, as well as our product development and regulatory activities. Kate?

Thank you, Dane. And I’m so excited to have you on our team. Let me start with an overview of recent activities related to our lead product Probuphine. During the third quarter, we established two new departments, medical affairs and drug safety and compliance. The Probuphine risk evaluation medication strategy or REMS program activities are administered through the latter. We’ve also hired a few highly experienced medical science liaison professionals, each of whom have strong medical community relationships, as well as expertise with Probuphine and with the REMS program training. Since early August, they have conducted numerous training sessions for new, as well as previously certified healthcare providers, on the Probuphine REMS program. This training activity has been an essential part of the transition, as it allows our medical team to engage directly with the healthcare providers. We gain firsthand knowledge of their experience and their needs and that facilitates building their skills as Probuphine treatment providers. Now in terms of ex-U.S. activities, we continue to support our partner Molteni as the EMA to review the Probuphine MAA that we submitted late last year. During the third quarter, we worked closely with Molteni to address all the questions raised by the agency during their initial review of our MAA. This is a standard process, and with several rounds of interactions with the agency to respond to their questions. We remain on track for a decision from the EMA in the first half of 2019. Now following the Health Canada's approval of Probuphine, for the maintenance treatment of stable patients with opioid use disorder in April of this year, Knight Therapeutics announced its commercial launch at the end of the last month. Although in a very early commercial stage, we understand Probuphine has, so far, been very well received by physicians in Canada. Under the license agreement with Knight Therapeutics, Titan's entitled for low double-digit percentage royalty on Canadian Probuphine sales. In this quarter, we also initiated preparations for conducting the first Probuphine Phase IV post-marketing requirement by FDA. The aim of this study is to evaluate safety in pharmacokinetics of reimplantation of Probuphine into a previously used site on a patient's inner upper arm as well as implantation into an alternate location in the lower abdomen. We also just received feedback from the FDA on the design of another required Phase IV trial to asses implant procedure safety in an observational cohort study design. And we hope to finalize that study design with FDA by the end of the year. Both studies are targeted for its initiation in 2019, and we believe will provide valuable data for healthcare providers and their patients. Finally, as Dane mentioned, here in the U.S., we also initiated a pilot program with the Nevada Center for Behavior Health, to evaluate a medication assisted treatment program within the State of Nevada criminal justice system using Probuphine for patients with opioid use disorder. We plan to establish similar pilots with other selected criminal justice programs with the goal of generating meaningful data that potentially supports the use of Probuphine and its important population. Moving next to our Parkinson's disease program. We announced early in the third quarter that the Independent Data Safety Monitoring Board had completed its review of data from the first cohort patients from our Phase 1/2 trial of the ropinirole implant. The DSMB recommended that we proceed with the enrollment of the second cohort to continue to study the implant safety, tolerability and pharmacokinetic profile. Although a positive development, we elected to postpone enrollment of the second cohort of patients. While our long-term strategy is to pursue opportunities to apply our technology platform to additional indication, we've made the decision to focus as many of our resources as we can on a successful re-launch of Probuphine in the coming month. And the last thing I will highlight today is some exciting news on the potential expansion of our ProNeura-based products and its pipeline. As Marc mentioned, we were awarded a 2-year NIDA grant of approximately $6.7 million in September. The grant provides approximately $2.7 million from now through August 31 of 2019, and the remainder during the second year of the grant, subject to successful progress and the availability of funds to NIDA. This grant will fund the IND-enabling development on a ProNeura-based six-month implantable formulation of Nalmefene, an opioid antagonist, for the prevention of relapse to opioid addiction in patients who have successfully undergone a detoxification program. NIDA has previously supported Titan in 2009 by awarding a grant of approximately $7.8 million in funding for control of Phase 3 trial Probuphine, and we are very grateful that NIDA is again providing its support to us. If these IND-enabling studies are successful and depending on the availability of continued funding to NIDA, the clinical portion of our grant application will be considered for another 3 years of potential funding. So as you can see, we've had a busy and productive third quarter. And I really look forward to keeping you updated on progress over the next several months. Now I'd like to turn the call to Brian to discuss Titan's financial results. Brian?

Thank you, Kate. A summary of the financial results was provided in our press release issued this afternoon and details are available in the Form 10-Q filed with the SEC today. At this time, I'll just highlight a few key items. Please note that all of the numbers, I'm about to provide, have been rounded, and are therefore, approximate. In the third quarter of 2018, we've reported $1.7 million in revenue compared to $40,000 in the same period a year ago. License revenues for the 2018 period reflect $0.3 million from the amortization of deferred revenue related to the March 2018 sale of the Probuphine European intellectual property rights to Molteni, and approximately $1.1 million related to the amendment the Molteni purchase agreement in August of 2018. In addition, we had our first quarter of product revenue since reacquiring the Probuphine commercialization rights, generating $244,000 from sales. For the third quarter, total operating expenses, consisting primarily of R&D and G&A expenses, were $3.6 million compared to $4.1 million from the same quarter in 2017. Our net loss attributable to common shareholders in the third quarter of 2018 was $2.3 million, or $0.11 per share, compared with the net loss of $4.2 million, or $0.20 per share, in the same quarter of 2017. In September 2018, we closed a previously announced underwritten public offering, which provided net proceeds of $8.5 million. At the end of the third quarter, we had cash and cash equivalents of $8.4 million. We believe that this combined with $4.6 million received from the sale of shares as a result of the underwriters exercise of the remaining overallotment option and the recent exercises of outstanding warrants is sufficient to fund our planned operations through the third quarter of 2019. Now, I will pass the call back to Sunil. If you have any questions, I will be happy to address them during the Q&A at the end of the presentation. Sunil?

Thank you everyone. As you have heard from the team, we are dedicated to a successful re-launch of Probuphine in the U.S. And under Dane's proven leadership, we have been working hard to advance our commercialization sales and marketing strategies to accomplish this goal. As I mentioned, our primary focus right now is to work with the certified healthcare providers already prescribing Probuphine, and to make it easier for them to identify additional patients that are likely to benefit from Probuphine, while improving the third-party payer reimbursement process. This is a win-win for all. I believe we have built a strong foundation for our commercial activities. And we have already started engaging with the other key market segments in the criminal justice system, academic addiction programs and residential treatment facilities. With successful entry in these strategic market segments, we expect to be in a strong position for long-term growth through potential partnerships with complementary companies. Kate has taken on additional responsibilities in a role of Chief Scientific Officer and put together a very capable medical affairs, safety and compliance team, that complements the commercial team. And she is available to the healthcare providers to address their ongoing training and medical queries. We will be initiating the required Probuphine Phase 4 clinical studies next year. And while our other product development programs remain an important part of the company's growth strategy, we shall advance these as resources allow. We've recognized that our ProNeura platform has the potential to benefit patients with chronic disease, and we will continue to pursue the development of other ProNeura-based products, once we have fully executed on the Probuphine re-launch. This concludes our prepared remarks for today. Before I open the call to questions, I would like to thank Titan's board of executive management and staff for their continued hard work and dedication. Sean, we’re ready to take questions from the call participants.

[Operator Instructions] Our first question comes from Ben Haynor with Alliance Global Partners. Please go ahead Ben.

So just like a starting off, yes, obviously, you guys have had pretty eventful last several months. I was just kind of curious on, I guess, what you've seen so far from -- in Q4 from existing prescribers? Are they continued to prescribe or are they increasing their prescriptions or implantations? Any color there you could provide there would be quite helpful.

Sure, Ben. It’s a great question. And obviously from the sales that we reported for the third quarter, we have continued providing the product and sales are occurring. But I will let Dane give you a flavor for how things are progressing.

Sure. Thank you, Sunil. Yes, so what we have found from going out into the market and discussing Probuphine with the physicians is that they're extremely happy that we've continued to support the access to Probuphine for the market. Titan is traditionally a science-based company. We’ve never commercialized prior to this. So we've been able to really set a strong foundation that facilitates access to Probuphine. In concert with that, working with Kate's team, a physician were coming up for expiratory on their REMS training, we've been able to quickly get -- say REMS trainers are our medical science leads on teams to those locations to recertify or provide the initial training to those clinicians. So overall, the response has been very positive from the physicians we've engaged with, as well as some of the peer discussions that we've had. They're also very excited about us supporting the Probuphine market access to their members. So all-in-all, it's been very positive.

And just thinking about it with your competitor out there having a monthly depot injection out on the markets for, I don’t about, 9 months now or so, it looks to me from the data that they've shared that each month is about 20% to 25% of the patients drop-off and don't get a subsequent injection. Is that themselves in that that's come up in your conversations with either physicians or payers or if you could down on the patient level?

So actually what -- I believe what has happened is that that is actually paved the way the long-term MAT therapy. So there are monthly injections. And I think what the providers and the patients really like about Probuphine is that we're a six months treatment. It's not a monthly injection. You're not going to see a drop-off when they insert the Probuphine rods. So I think the favorability towards our products for those that have dropped-off is fairly positive in terms of the treatment.

Yes, I mean, that's going to validate. What are the expected now? But, yes, you never know.

Right.

And then, just thinking about the criminal justice opportunity, I know, you have the agreement with Nevada. Have you done the first implants there? And have you had discussions with corrections department or criminal justice systems from other jurisdictions yet and -- or and if so, are they waiting anything from the Nevada program? Or are people willing to process sooner rather than later? I think any color that you have there that you can provide that would great.

That's a great question, Ben. Hi, this is Kate. Yes, we have been working very closely with the Center for Behavioral Health, which is leading this pilot program in criminal justice system in Nevada. We have trained approximately 15 to 20 of their healthcare providers. We got a very, very positive response for the healthcare providers throughout that chain. All of them are recertified and they are ready to go. They are at this stage identifying patients -- appropriate patients according to the product labeling, which are clinically stable patients on a dose of 8 milligrams or less a day who the healthcare provider is gaining to be appropriate for treatment. That's the process where we are. And we expect that -- in the coming weeks and months that there would be orders coming in across the entire criminal justice system of that system. And as you are probably aware, it's a very complicated initiative system.

That was kind of my next question. It's obviously - you've got the incarcerated population. You've got the probation population. You probably have it another couple of populations that I'm not thinking of. Hasn’t been difficult to navigate any of those populations in particular? Or has it gone relatively smoothly once you've gotten buy-in from the visitors or the managers?

At our first training -- we've actually done two trainings for the Nevada group right now. The first training we had representatives from all the different passage of the criminal justice system represents the jails, the drug court system, the half way had etcetera. And there is uniform interest and acceptance because as you can imagine, clinically this is a product, this is a treatment that is appropriate for anybody in any stage of the incarceration process. So we’re hopeful that we’re going to see some orders coming in the coming weeks and months. But as I said, we’re in the process now of identifying the right patients for treatment.

And Ben, this is Sunil. Just to add one thing to keep in mind that treatment of incarcerated patients has not been something that has been in place before. So when a state like Nevada takes on this endeavor, it is a major commitment that they are making to it, and they have to establish all of their own internal procedures and so on to how they will manage the patients and how they will handle the follow-ups and things like that. So more than just thinking of it as a simple, let’s get a patient on it, they need to establish that system. And that's what we are helping them establish and seeing where exactly Probuphine fits, so that the long-term benefits are really what will happen here. So I expect to see this building in creating sort of a model that other states can follow. So it's an important program.

And then, I guess, a follow-up on that. If that, if they get a protocol in place and all that occurs that’s for the patients that are in jail or in prison, would that eventually, potentially lead to all of the patients that are stable on the daily treatments being implanted in Nevada? Or am I digging too much into that?

Well, and I think what it would lead to is the identification of the appropriate patients. And we know that across the Board, not just in Nevada, but in across the U.S that 25% of people, who are in the criminal justice system in all stages of it, had opioid use disorder, and it's largely untreated. So this is a lot of people. We’re starting with a small pilot program, so that we make sure that we understand the right way to treat these patients who desperately need the treatment. And then our highest objective here is to protect them, especially once they are released and they have a very high potential rate of relapse and overdose. That’s really what we’re aiming for.

And then, I guess two more quick ones from me if it's all right. On the investigator sponsored trials, it sounds like that will add a minimum inform the trails that you might do in the future to extend the label? Or could those actually help you expand the label from new guys not do any trials but just taking the investigator sponsored data to the FDA?

That is very good question. And typically investigator initiated or investigator sponsored trials are not sufficient. Don’t lead to supplemental and new drug applications. However, I certainly seen it done both ways in different companies that I've worked with in the past. What they're very, very valuable for though is picking up signals that would lead to ideas for larger development programs that we would then conduct in-house to meet all the regulatory requirements required for the submission of an SNBA [ph].

That’s very helpful. And then lastly, it looks like that you saw quite a few warrant exercises just in the scheme of things. Does that look like kind of 30% of the warrants that are outstanding and have been exercised or can you kind ballpark that for me?

It's about 30%. It's roughly $13 million of the $43 million or so.

Our next question comes from John Vandermosten with Zacks SCR. Please go ahead John.

I had a couple question just on the cash flow issues. The first was on Nalmefene, I think, that's rightly pronounced. And that $6.7 million is supposed to come in. Is that going to come over -- or what period is that supposed to come over and when should we expect to see those flows?

The grant itself is over a 2-year period, and up to $6.7 million, the $2.7 million is for the first year, and that period really is from September of this year to the end of August of next year. So it's sort of little bit odd in terms of timeframes. But that's the first year for the $2.7 million, and the second year, which is literally starting in September of next year to 2020 -- August 2020. That will end up with $4.4 million during that period. So the cash flow is based upon -- I mean the first part is mostly geared towards formulation development and initial work, and then the second year is year towards doing the work for all of the non-clinical IND supporting work that is necessary. So that's how it's split-up.

Okay. And to those graphs come at the end of that fiscal year period or at the beginning of it or notably over the whole thing?

See, the funds are available over the period of time as we incurred costs. We will then submit them for reimbursement during that period. So it’s not actually at the end of the year. It is throughout the year based upon actual expenditures.

Second cash flow related question just on the Phase 4. And what kind of quarterly cash burn rate might we see just allocated to that effort? And I'm getting the impression about the second half '19 when we might see that. But any help if you can give on the modeling side would be great.

Sure. John, in this setting there are two key studies, as Kate described. The first one is a smaller study in the sense that -- and it's very important study, but the number of patients will be a lot smaller compared to the second one. And this is a study where we are looking at re-implanting in a previously used site or a new site. That study, I think as we had indicated previously as well, it's something that will end-up costing $3 million to $4 million. It will be roughly 2.5 years to 3 years timeframe for the full study. And it will start in early part of next year.

Okay.

Okay. The second study is a much larger study. And once, I mean, I don't want to give the numbers right now. I have to sort of mention it. When we actually start the study, you'll know the details. But that is a observational study, but it's a prospective observational study. We haven't yet worked out all the details of the things that are still being discussed with the FDA. So the exact protocol is not yet in place. And this is going to be more expensive. But I really don't have the sense of how much. And it will start sometime and I should say expensive, but it's only in comparison. I mean it's probably going to be $6 million to $8 million type of the thing over a 4-year timeframe. And that will start sometime in the latter part of next year.

Okay. That is very helpful. And just moving on to Canada, again, I mean, I'm excited about that because there -- I assume that head for sales right now, in the November. Will they face some of the same hurdles that Braeburn faced in the U.S. and getting started? And I'm wondering, are there any things that they are worried about, obvious, of the health plans are different up there in the United States. But can you point out any hurdles that they may face that have anticipated?

In terms of the marketing strategy that and -- Knight Therapeutics has set up and so on. I mean I don't want to get into a lot of detail. It's something that had to wait till they make their own public announcements on this. But in general, there are pros, obviously, with the different healthcare structure there. The pricing is very different, the availability of different medications, including the injectables and so on, and the use of that in different populations is quite different than here. So all I can say is they really have looked at this and come-up with a targeted population strategy thing where would the implants be best suited. And I believe they really haven't looked at a very good approach of saying, hey, patient populations in Canada who cannot easily or not in urban regions for instance, and cannot quickly get to a doctor or a clinic and do on, would be ideally suited with an implant approach, and that's what they are targeting.

And when I was asking that question, I was thinking some of the hurdles that Braeburn felt or experienced with, just reimbursement and then the REMS and things like that. I mean, I don’t think any of those hurdles exist that fair, but I don’t know two of the Canadian systems, but just was wondering that it's just one that's easier because of the way it's structured.

Little bit easier with the better way to put it. I’m they will -- I'm sure, have their own hurdles as everyone does with new treatment. But clearly, the third-party payer is not the primary driver over there. Once they get pricing approval from their healthcare system, it is lot easier for all of the different regions essentially within Canada to access the drug.

And last question is on, I think, maybe a question for Dane. And congratulations for getting out of the team, Dane. I was going to ask about, I think, there was a three-pronged strategy to pursue payers, patients and physicians. And I was just wondering how that was progressing and very distant update on how that that three-pronged approach is working? And … that's it.

Absolutely, absolutely. Yes, good question. The approach has been to really put the fundamentals in place, to put a strong foundation in place. And that means working with --bringing strong regulatory compliance group to review and ensure that all of our promotional materials are approved internally before submitting to OPEB with the government with the FDA to ensure that we are having those engagements with the physicians to understand their needs, their patients' needs, their caregivers. So along with that, we really have to do our segmentation properly, to understand the whys. We were asking why Probuphine or why you're making therapy to the payers, to the clinicians, to caregivers and patients, and to understand overall, how we can be more effective as a company in delivering healthcare to the providers and the members. So when we get their feedback, we were assemble or assimilate that and they still that down to the right messaging, so that we are finding the correct physicians that want to treat their patients with long-term MAT therapy, as well as the right patient populations. Along with that, we have to have access. Whenever you launch a drug, you generally, well, you always launch with the payers first to have those discussions, to reduce the amount of hurdles and obstacles for access. So we very quickly talk to some of the major players in the country to get their feedback from medical directors and pharmacy directors to understand their thoughts are on MAT as well as Probuphine. And the response has been overwhelmingly positive that the long-term therapies are something that they want to see utilized within certain patient populations and segments. And so we have seen a strong uptake really in orders. And so I believe we can -- we'll see an even stronger uptake going into the first quarter of next year. And so, as long as we were able to have the right folks in the right areas, I see a clear path for us.

This will now conclude our question-and-answer session. I would like to turn the call over to Mr. Sunil Bhonsle for any closing remarks.

Thank you, Sean. Thank you everyone. I really appreciate your ongoing support and your participating in this conference call. It is our goal to keep you all updated over time. And we will continue to do so. I certainly look forward to talking to you guys again early next year. In the meantime, happy Thanksgiving from all of us to everybody, and have a great day.

The conference has now concluded. Thank you for attending today's presentation and you may now disconnect.