Titan Pharmaceuticals Inc (TTNP) 2019 Q4 法說會逐字稿

Thank you for holding, and welcome to the Titan Pharmaceuticals Fourth Quarter and Full Year 2019 Financial Results Conference Call. (Operator Instructions) 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 conference over to Sunil Bhonsle, President and CEO of Titan Pharmaceuticals. Please go ahead.

Thank you, Andrea, and thank you all for joining us. Welcome to the Titan Pharmaceuticals call to review financial and operational results for the fourth quarter and year ended December 31, 2019, and provide an update on our business.

Before we begin, I wanted to inform you that we have filed our 2019 annual report on Form 10-K with the SEC. And the press release issued today provides a summary of the results, and these can be found on our website at titanpharm.com. I also want to take this opportunity to thank the team at Titan, our audit staff at OUM and our counsel at Loeb & Loeb, who have worked tirelessly from their remote locations, including over the weekend, to issue these reports on schedule. So thanks, everyone.

Joining me on the call today from Titan are Dr. Marc Rubin, our Executive Chairman; Dr. Kate DeVarney, Executive Vice President and Chief Scientific Officer; Dane Hallberg, Executive Vice President and Chief Commercial Officer; and Brian Crowley, Vice President of Finance and Administration.

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 commercialization and 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 condition 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; Titan's ability to access capital; 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. As always, we will start the call with an overview from our Executive Chairman, Dr. Marc Rubin, followed by commercial updates from Dane Hallberg, and then medical affairs, regulatory and product development updates from Dr. Kate DeVarney. 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 to everyone, and a special thanks to all of you who are able to join us today during these very challenging times. Before I begin, I'd like to briefly tell you about what we are doing in response to the COVID-19 pandemic. As the situation continues to evolve, we are diligently monitoring and implementing recommendations from local, national and global health organizations. Titan's top priority is the health and safety of our employees, our customers and the communities in which we live and work. To that end, we have put proactive precautionary measures in place, including sheltering in place and working from home, freezing all nonessential travel and switching exclusively to virtual sales and business meetings, with the goal of keeping everyone as protected and as safe as possible. At the same time, we remain deeply committed to continue to execute additional components of our growth plan during 2020. Everyone at Titan is working remotely, and I am pleased to say we continue to be productive. We sincerely hope that all of our stakeholders will remain safe and healthy as well.

Turning to an overview of 2019, throughout the year, we laid the foundation and we worked to create the infrastructure required to successfully transition to a commercial stage company, and we made meaningful progress on a number of important initiatives. And some of these include the following: we refined and validated our market segmentation strategy; we expanded our specialty pharmacy network through the addition of key pharmacies with national coverage and robust coordination of care capabilities among patients, third-party payers, and risk evaluation and mitigation strategies or REMS-certified health care providers; we streamlined the distribution process with a new hub to coordinate the REMS requirements; and we conducted the initial evaluation of health benefits available from third-party payers; and utilized a digital portal to simplify the product ordering process, all of which helped significantly shorten the time from prescription to product delivery; we expanded the number of public and private insurance plans and other third-party payers that cover Probuphine under the medical and pharmacy benefits such that more than 90% of insurance plans now offer some degree of coverage for Probuphine; we implemented a comprehensive regulatory and compliance program; we rolled out new health care provider, caregiver and patient education programs; and we grew the number of certified health care providers of Probuphine.

I'm very pleased with our team's progress during 2019, especially given the resource constraints that we as a company have faced. Subsequent to year-end, we strengthened our balance sheet via a registered direct offering and exercises of warrants that well positions us to continue to execute on our growth strategy during the year. An important 2019 milestone was the European Commission's approval of Sixmo, which is the brand name for the product in the EU, establishing this as a global -- true global product. Sunil will provide an update on this program in his closing remarks.

On the ProNeura front, we were very pleased to announce the National Institute for Drug Abuse's, or NIDA's, approval of second year funding for our nalmefene program, and Kate will provide more details on that in a few minutes.

Finally, once again to all of you listening, please stay safe, stay home as much as possible and stay healthy.

And with that, I will now turn the call over to Dane, who will elaborate on our commercial activities and the progress that he and his team have made. Dane?

Thank you very much, Marc. During 2019, our focus was on establishing relationships and programs necessary to build our infrastructure and to grow our commercial capabilities. We expanded our specialty pharmacy network, improved our patient services via our new hub partner, added marketing initiatives to include federal agencies and increased our sales force coverage span. As a result of these sales and marketing efforts, we have realized an increase in both coverage and the number of prescribers of Probuphine.

Our commitment to our customers, patients and their caregivers remain strong, even in this current environment with COVID-19. We have implemented strategies that allow all of our field teams, field sales, REMS, medical and hub to continue to provide the support and tools in treating OUD.

As I mentioned, we expanded our specialty pharmacy network through a number of national partnerships, AllianceRx Walgreens Prime; Accredo Specialty Pharmacy, a subsidiary of Express Scripts and one of the largest U.S. specialty pharmacies; CVS Caremark, a subsidiary of CVS Health and among the largest prescription management and pharmaceutical services business in the U.S. We've also established a regional partnership with Southside Specialty Pharmacy, which has a strong presence in California and Texas. These 2 states are among those reporting the highest number of opioid-related deaths in the U.S.

We've improved our hub patient services with AppianRx with minimal disruption to the supply chain, and implemented a more efficient process that reduced prescription to product delivery time from 3 months to 2 weeks.

2019 also saw the launch of our Step into Stability branding campaign, which highlights the unique long-term treatment features of Probuphine, and included a health care provider portal and branded patient website to provide patients and their caregivers easier access and improved visibility to locating qualified health care providers. We also executed a federal supply schedule pricing agreement that went into effect January 15, 2020, and has a 5-year term.

We are currently establishing a virtual training program for VA clinicians who elect to add Probuphine to their OUD treatment protocols for VA beneficiaries and others within the federal system, offering another solution to our veterans in need. Recently, we expanded our sales and marketing capabilities with the addition of senior sales account managers and support personnel in key geographies, which will enhance our ability to service our customers and grow Probuphine-related revenue.

To summarize some of our key accomplishments to date, at the end of 2019, we had 282 active prescribers and the number of active health care providers continues to steadily increase. We achieved broad product access through a comprehensive product distribution network and by utilizing strategic partnerships. We continue to see growth in prescriptions with an 18.6% increase in Q4 versus Q3. We significantly reduced the time between prescribing and product availability for our providers and our patients. We are proactively reducing barriers to therapy, specifically, legacy reimbursement rate for Probuphine insertion and removal as it pertains to the centers of Medicaid and Medicare services, also known as CMS. The current CMS and many private payer rates do not adequately or fairly reimburse health care providers for these procedures, oftentimes costing them more out-of-pocket than the maximum allowed. This may unfairly prevent patients from receiving the appropriate treatment. We are actively trying to engage CMS to have a frank and honest discussion regarding fair and adequate reimbursement with key opinion leaders.

While we fell short of our goal of 500 prescribers by year-end, our main focus throughout 2020 will continue to be to increase the number of active prescribers with the goal of achieving broad product access via our fortified patient support model. This model will support those clinicians who prefer to only prescribe Probuphine to elect the option to have REMS-certified clinicians insert and remove Probuphine on their behalf. Our patient support model is built on the foundation of our updated hub partner, along with our matrix of prescriber support teams that include medical, REMS, compliance and marketing. This model is currently under a soft launch in select geographies, with the goal of rolling out nationwide by year-end and was created with the goal of removing another potential hurdle for patients and clinicians alike.

As Marc mentioned, our commercial activities have been impacted by COVID-19 crisis. As have the majority of commercial organizations around the world, in light of our rapidly changing environment, we moved very quickly to protect our employees and our customers as well as support our providers so they can continue to serve their patients. By training our field sales team to work remotely via the phone, we quickly pivoted our commercial efforts to ensure clinicians and patients have unfettered access to Probuphine. We updated our existing plans to quickly and thoughtfully bring on highly skilled talent in areas of reimbursement, operations, marketing, PR, telemedicine and implemented several support initiatives in all of our key channels as well as added new senior sales professionals who can now support any office, patient or caregiver in the country via virtual means.

Finally, I'd like to share my thoughts in light of the COVID-19 pandemic. Probuphine's value proposition continues to grow and improve as the call to action for stronger patient compliance, steady medication delivery and the peace of mind of patients and providers alike are greatly enhanced. Our relentless efforts to support our customers and their needs are a critical part of successfully navigating these trying times for our providers, our patients, caregivers and, of course, our Titan employees.

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. As Marc mentioned, we were pleased to announce that NIDA approved approximately $6.1 million in second year funding for our nalmefene development program for the prevention of opioid relapse following detoxification. The aggregate potential expense reimbursement to Titan is approximately $8.7 million, which provides funds for the completion of implant formulation development, GMP manufacturing, and the nonclinical studies required prior to commencing any clinical studies under an IND. We are currently conducting these studies and recently participated in a pre-investigational new drug meeting with the FDA to review our nonclinical development plans and obtain their guidance regarding filing an IND application by the end of this year or in early 2021.

In other ProNeura development activities, we continue to collaborate with the Walter Reed Army Institute Research, or WRAIR, and Southwest Research Institute, or SWRI, in the early nonclinical evaluation of the ProNeura platform for malaria prophylaxis. The early data from this collaboration is encouraging, and WRAIR has received additional funding from the Department of Defense to continue the program, with additional nonclinical testing of the atovaquone and proguanil implant formulations in large animal studies. WRAIR is also pursuing additional grant funding for testing other compounds that have shown promise as prophylactic treatments for malaria. And we look forward to collaborating with both WRAIR and SWRI for the preparation of these implant formulations, which, if successful, could be available to us for potential commercialization.

And now shifting to our Probuphine activities. Our medical affairs and drug safety compliance team has been focused on providing Probuphine training and certification to health care providers across the country. During 2019, we attended multiple professional conferences to raise awareness of Probuphine, and we were very pleased with health care providers' interest and participation in REMS training sessions. We've also been focusing our resources on providing medical and REMS training support to the commercial team, and we will continue to do so.

Now as I mentioned on our last call, we have postponed the Phase IV studies in an effort to preserve our resources, and we have discussed our plans with the FDA in a conference call last quarter. Before I turn the call over to Brian, I'd like to talk briefly about how the COVID-19 pandemic is impacting exactly how health care providers are monitoring and treating opioid use disorder patients. People with opioid use disorder comprise one of the most vulnerable populations at risk for morbidity and mortality during this pandemic, not only from COVID-19, but from their underlying addiction and other potential co-morbid diseases. So it's critical that people who need medication-assisted therapy like Probuphine and other addiction treatments are able to receive them safely and consistently in the context of the ongoing COVID-19 emergency. And this emergency threatens to curtail patient access to evidence-based treatment.

At the request of the Substance Abuse and Mental Health Services Administration, or SAMHSA, the Drug Enforcement Agency, or DEA, announced that it would grant an exemption for telemedicine to be used in place of initial in-person visits. I have spoken with some of our Probuphine health care providers who have informed me that they are now using this new treatment paradigm effectively. While we evaluate how this may impact our business, we are working rapidly to ensure that the insertion and removal procedures are not barriers to both health care providers and patients during this difficult time. We're in the process of developing a virtual REMS training program so health care providers can continue to be trained to prescribe and administer Probuphine, and we are also creating specialty treatment clinics where patients may receive Probuphine safely during the corona pandemic. This program will be shared with the FDA once it is finalized.

That concludes my remarks for today, and I look forward to keeping you updated on our progress over the next several months. Now I'll turn the call to Brian to discuss Titan's financial results. Brian?

Thank you, Kate. A summary of our financial results was provided in our press release issued earlier today, and details are available in the Form 10-K filed with the SEC. At this time, I will just highlight a few key items. Please note that all the numbers I'm about to provide have been rounded and are therefore approximate.

In the fourth quarter of 2019, we reported $1.2 million in revenue. This included $0.2 million from product sales, $1 million related to our NIDA grant. This compares with $1.2 million in revenue during the same period a year ago, which was comprised of $0.2 million in product sales, $0.3 million related to the amortization of deferred revenue related to the sale to Molteni of the European intellectual property rights of Probuphine, and $0.7 million related to the NIDA grant.

Total revenues for the year ended December 31, 2019, were $3.6 million, which includes $0.3 million in license revenues, $1 million from sales of Probuphine and $2.3 million related to our NIDA grant. This compares to total revenues of $6.6 million in 2018, which included $5.4 million in license revenue, $0.5 million from sales of Probuphine and $0.7 million related to our NIDA grant. The $3 million decrease resulted primarily from non-recurring license revenues in 2018 of $3.2 million in upfront and milestone payments for Molteni and $2.1 million related to reacquiring the rights to Probuphine during -- or Probuphine from our former licensee, which was partially offset by increases in product revenue of $0.5 million and grant revenues of $1.6 million, and 3 -- or $0.3 million of license revenue, which represented the remaining amortization of the 2018 Molteni upfront payment during 2019.

For the fourth quarter, total operating expenses, consisting primarily of R&D and SG&A expenses and cost of goods sold, inclusive of distribution expenses, were $5 million compared to $4.5 million in the same quarter in 2018. Total operating expenses for the full year were $20.5 million in 2019 compared with $14.9 million in 2018 and consisted primarily of R&D and SG&A expenses. R&D expenses for the year ended December 31, 2019 were $7.3 million compared to $7.5 million in 2018. The decrease in R&D costs was primarily associated with decreases in employee-related expenses and other research and development expenses, partially offset by increased activities related to the NIDA grant and an increase in our contract manufacturing costs.

SG&A expenses for 2019 were $11.9 million compared to $6.9 million in 2018. The increase in SG&A expenses was primarily due to higher sales and marketing expenses related to establishing the infrastructure to streamline the Probuphine ordering and distribution network, and increased expenses associated with expanding Titan's Probuphine commercial activities.

The net loss applicable to common shareholders in the fourth quarter of 2019 was $4 million or $0.08 per share compared with a net loss of $3.5 million, or $0.29 per share in the same quarter in 2018. The full year -- for the full year 2019, our net loss was $16.5 million or $0.72 per share compared with a net loss of $9.3 million or $1.64 per share for 2018. At December 31, 2019, we had cash and cash equivalents of $5.2 million, which we believe, along with the net cash proceeds of $8 million received from the January 2020 offering and the exercise of warrants during the first quarter of 2020, are sufficient to fund our planned operations into the fourth quarter of 2020.

Now I'll pass the call back to Sunil. If you have any questions, I'll be happy to address them during the Q&A at the end of the presentation. Sunil?

Thank you, Brian. So let me begin by providing a summary of our activities with our 2 partners, Knight Therapeutics in Canada and Molteni Farmaceutici in Europe. During this past year, Knight was focused on obtaining product pricing approvals and formulary listing from the provincial health authorities. And early this year, the provinces of Québec, New Brunswick, Newfoundland, Nova Scotia and Manitoba joined Alberta and Saskatchewan in providing access to Probuphine as a treatment for opioid use disorder in eligible patients. Knight is ramping up their product promotion activities in these provinces, while they continue to pursue listings in the remaining provinces, especially Ontario and British Columbia.

As you know, Probuphine was approved by the European Medicines Agency in late June 2019. And our partner Molteni commenced the next steps towards commercialization of the product, Sixmo, which is the trade name for Probuphine in Europe, specifically applying for registration and pricing approval in the key countries, first of which are expected during the first half of this year.

Now we have been working very closely with the team at Molteni to plan the manufacturing of the buprenorphine implants that will meet all EU regulations. This has required some modifications to the facility at our contract manufacturer, DPT. And the qualification of the modified facility is nearing completion, with production scheduled very shortly. A word of caution, however, with the coronavirus spreading across the U.S., we're all monitoring the day-to-day changes in the work environment and hoping that the production at DPT in San Antonio will remain on schedule. Also, we hope that Molteni, with their headquarters in Italy, one of the worst affected countries at the present time, will be able to complete some of the work like packaging of the kits and testing as planned to enable the scheduled product launch activities. And we will keep you posted on developments as we go along over the next few months.

Now just a quick summary of last year. During 2019, Titan was keenly focused on executing our Probuphine relaunch strategy. And with a lot of hard work from our team and our partners, we have made good progress. While the product revenue in 2019 of about $1 million average the same pace as the second half of 2018, we now have the infrastructure in place. With a strengthened balance sheet, we're well positioned to expand and support our commercial operations and continue streamlining the specialty pharmacy distribution process, expanding training to mid-level providers, such as nurse practitioners and physicians' assistants, and through targeted marketing efforts, reach out to additional health care providers who have a patient population undergoing buprenorphine maintenance treatment. I am pretty clearly excited about implementing the fortified patient support model that Dane described. It utilizes the strengths of the trained and qualified health care providers, allowing the insertion and removal procedures to be performed by those best suited for it, and permitting many other health care providers in the community to prescribe Probuphine to their patients without having to set up the system to perform procedures. I believe this could be a win-win for all.

Also, there are a number of marketing and social media-oriented initiatives that may help patients and health care providers choose the right treatment approach with long-acting products like Probuphine. The sales territory managers are well supported by the medical science liaison team, and together, they can provide the right service for the health care providers and their patients. Kate and her team are developing an innovative virtual process for providing training to health care providers that should be very beneficial in the current environment.

Also, our nalmefene implant project is progressing with the team working diligently to get all the nonclinical data necessary to file an IND, hopefully, by the end of this year. And we thank NIDA for their ongoing support. Our management and the Board recognize the shareholder sentiment and are being careful to use the limited resources wisely and keep expenses within our means, including a 6-month 50% reduction in Marc's and my salaries, while at the same time maintaining an environment for growth of our business.

A word of caution, however. We are somewhat in uncharted waters at the present time, with the rapidly changing environment created by the coronavirus pandemic. We are trying to navigate our way through these obstacles while keeping in mind that the first priority must always be the safety of our employees and partners, the health care providers, and most importantly, the patients. We will try to do our best to reach our goals. And as always, we will keep you updated.

This concludes our prepared remarks for today. Before I open the call to questions, I'd like to thank Titan's Board, executive management and staff for the continued hard work and dedication during this difficult time.

Andrea, we are ready to take questions from the call participants.

(Operator Instructions) And our first question comes from Anita Dushyanth of Zacks Investment Research.

First of all, I just want to say that I'm filling in for John today from Zacks, and please pass on the congratulations to Dr. DeVarney on her appointment to the Board. Just have a couple of questions here, I know you already answered a few. Probuphine was recently added to the federal supply schedule. Do you have any resources that show how many veterans comprise of the addressable market for Probuphine?

Anita, thank you for filling in for John. I appreciate -- I know this is time where there are many companies providing their financial results calls at the same time. In terms of specific numbers of those suffering with OUD that are part of the VA system, I know Dane has looked at that specific population. Dane, you want to address that?

Sure. Thank you, and thanks, Anita, for the question. The -- essentially, the VA with the veterans, they are affected at about 50% greater in terms of being affected by OUD. So we know the population as a whole is affected at a higher rate than the general population. The total number of veterans that are impacted by OUD, we -- those specific numbers, I haven't seen those published yet. But it -- looking at what we -- from the data sources that are available, we know that it is significant. We can reach over 9 million veterans, but 9 million is not the number impacted by OUD. We have -- we need to get a more granular look at that data. But we do know, overall, that veterans are impacted at about a 50% greater rate than the general population. So we know that -- which is one of the reasons why we wanted to contact appropriately with the government, was to ensure access and ensure that, with Kate's team, that we're able to train the doctors who elect to use Probuphine in their practices to do so. But that is what we have at the moment.

Okay. And who besides the VA might pull from the schedule?

Well, the FSS is the federal supply schedule. So any -- TRICARE, any federal agency that utilizes the FSS could potentially have access to Probuphine. They would just have to put that -- obviously, get trained and then put the request in, normal procedures to get the reimbursement.

Okay. Okay. And regarding the pricing discussion of Probuphine. Could you throw some light on how the pricing will be in Europe as compared to U.S.? And also if your discussions have been favorable so far?

Anita, in terms of pricing in Europe, really, Molteni handles that directly. What I'm aware of, generally, the level of pricing that they expect to get, which will be somewhere probably in the range of 40% or so less than the U.S. pricing, that's typical of European pricing policies in there. It is quite substantially higher than, let's say, the currently available treatments in Europe. And at this stage, Molteni has focused initially on the 2, 3 countries where the expectation of pricing is higher because of the typical health care systems that they have, such as Germany, U.K. And that's where they will be able to establish an appropriate price, provide the product into those markets and show the benefits of the product. And that allows the product to be appropriately spread through the rest of Europe. So it's a very staged approach that will be taken as they go forward. But once the first 2, 3 country pricing is set, it creates the environment where you can actually spread into the other regions of Europe, with very specific targets in mind, and use partners who already have boots on the ground and can do the work with you.

So that's the kind of strategy that I expect Molteni will be following. But truly, maybe in one of these calls, obviously, with Italy being really direly affected by the current pandemic, but maybe in the next 6 months, one of the calls, we will have our partners from Molteni participate and provide some guidance as well. Okay?

Okay, okay. My other question was kind of related to the active prescribers. You probably mentioned in the call, and maybe I missed it, but you said there were 282 active prescribers as of end of 2019. What was kind of your target number you're looking at that you're working towards this year?

Yes. Our original target at the middle of the year when we started looking at this, we said, well, we really would like to have 500 active prescribers. For various reasons, the -- where we are at this stage is that the number that Dane mentioned. But we still are continuing to grow. So we will see -- we'll get to the 500 numbers, I have no doubts about it. We are looking at establishing, as we said, certain models that will help expedite that process, especially the ability to utilize sort of the centralized process for the insertion and removal of the implant. So not every physician who can prescribe the product needs to be trained to do that. We want to use these capabilities of those who like doing the procedure to focus on getting the procedure and let those who like prescribing the product prescribe it and use the services of these. In that way, we can expand the number of active health care providers a lot faster. I mean these are the things that Dane and his team have learned and they're trying to now change the paradigm to implement ways where we can move faster. Okay?

Okay. And what are kind of the approval rate for the prescription request?

When you say approval rates, in terms of the processing through third-party payers? Is that...

Yes.

Dane, do you want to address that?

Yes. Yes. So we have about 94% coverage on the medical benefit side for the drug. It depends on patient benefits, but we have a very high, I guess, success rate in terms of approvals. It's upwards towards 70%, but it really is dependent upon the individual patients' benefits. Many states, they reduce the barriers, the PAs and the steps. Others haven't. But it really depends on the medical exception provided by the clinician that's acceptable to the payer, whether private or Medicaid. But we do know that we have 94% coverage and a very, I would say, a very high rate of approval. But then again, it really is dependent on every individual patient's benefits, as with any medication.

Right. Right. Okay. Okay. And just one last question for me. Do you have any metrics to share on your website portal performance?

Could you -- the portal performance, could you clarify?

Yes, the -- you were going for the online telemedicine kind of thing.

Okay. So we have a physician portal that's instead of paper-based portal that's available to clinicians to enroll patients to -- for the prescribing process. We don't publish those. That's a firewalled private area. But we do have other metrics that we plan on reviewing with -- internally before providing publicly within -- with Sunil and the team. And -- but for those prescriptions and the way the physicians utilize portals, those are, for the most part, firewalled from us and from the public. If you can...

Our next question comes from Jason McCarthy of Maxim Group.

It's Dave on the line for Jason. I just had a question here. You mentioned earlier on that the Phase IV post-market clinical trials have been temporarily put on hold in light of the COVID-19 pandemic. Could you shed some color on when you expect to reinitiate these trials?

Sure. I mean I think the clinical studies, there were 3, and 1 of which we actually will participate in and then 2 have been postponed. But I'll let Kate give you some color around that. Kate?

Yes. Dave, can you hear me okay?

Yes. I can hear you.

So we have 2 -- we've got 2 post-marketing clinical studies that we are committed to doing, that we have put on hold due to our resources currently. One is a study that look at reimplantation into a previously used site and also implantation into the lower abdomen, a different -- giving clinicians an alternate site. And that's a pharmacokinetic study, small study. Another study is a larger study, and that's looking at implant safety in large observational cohorts.

Now these studies are, as all clinical studies, are expensive and we are conserving our resources right now until the time is right when we can initiate them. We have been in regular communication with the FDA regarding the study time lines, and FDA so far has been very supportive of this.

The third study is a cardiac safety study that we have been asked by the FDA to collaborate with some of our other companies in the buprenorphine space. So we're in the process of doing that. We have a final protocol that is currently under review at the FDA. And I anticipate that in the coming months, we will be starting that study. I don't know what kind of impact the current pandemic environment may have on those study time lines. As you can imagine, doing a clinical study in an age of extreme social isolation and perhaps even quarantine is really challenging, especially when you have to do a surgery for subjects. So we'll keep you updated as we figure all of that out, and that's really all I can say at this point about those studies.

Okay. No, for sure, it's definitely understandable. It's difficult to -- given the times that we're in right now. Just another quick -- point of clarification here. Earlier on, you mentioned that you guys saw an 18.6% increase in active prescribers compared to 3Q '19, is that correct?

Dane, you want to address that, the percentage of prescriptions that we're referring to? Yes, the increase and...

Yes, can you state the question again, please?

It's just as a point of a clarification. I just wanted to make sure I got the number down correctly here. You mentioned that you guys saw an 18.6% increase in active prescribers in 4Q '19 compared to 3Q '19, is that right?

No, those were the actual prescriptions. The prescription or...

The [prescription]? Okay.

Yes, yes, correct. The enrollments to the -- yes, the enrollments to the prescriptions increased 18.6% in Q4 versus Q3.

This concludes our question-and-answer session. I would like to turn the conference back over to Sunil Bhonsle for any closing remarks.

Thank you, Andrea, and thank you all for participating in this call. I appreciate very much your taking the time at this somewhat difficult times that the whole world is facing. We truly appreciate your ongoing support. And I would like to express from the Titan team that you truly take care of your health, stay safe, and we will all work hard to advance our Probuphine program as well as develop products using our ProNeura technology during this pandemic. Thank you very much, and have an excellent day.

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