Q4 2019 Earnings Call

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 off and you're ended December 31st, 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 Lounge has issued today provides a summary of the results, and these can be found on our website at Titan Farm.

I also want to take this opportunity to thank the team at Titan our audit staff at our council at Loeb & Loeb who have worked tirelessly from the remote locations, including over the weekend to issue these reports on schedule. So, thanks everyone joining me on the phone call today from Titan Eye Doctor Mark Rubin our executive chairman doctor Kate de Varna Executive Vice President and chief scientific officer harburg 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. Jeniffer. Caren will review the required cautions regarding forward-looking statements.

Jennifer

Thank you for meal. 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 a 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 with 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 producing the regulatory approval process Titans ability to access Capital the development testing production and marketing of our drug candidates patent and intellectual property.

matters and sticky

Just agreements in 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 I have to use email

Thank you, Jennifer. As always we will start the call with an overview from our executive chairman. Dr. Mark Rubin followed by commercial updates from st. Albert and then medical Affairs Regulatory and product development updates from dr. Kate. Duvarney probably will then summarize the the actual results and I will close with a brief recap before opening the call for your questions. So let's get started mark. Thank you very much 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 a situation continues to evolve we are diligently monitoring and implementing recommendations from local National and Global Health organization's off Titans top priority is to health and safety of our employees or 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 non-essential travel and switching exclusively to Virtual sales and business meetings off with a goal of keeping everyone has protected in a safe as possible.

At the same time. We remain deeply committed to continue to execute additional components of our growth plan during 20/20. Everyone. A Titan is working remotely and I am pleased to Thursday. 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 with a number of important initiatives.

And some of these include the following we were fined and validated our Market segmentation strategy. We expanded our Specialty Pharmacy Network through the addition of key pharmacies wage national coverage and robust coordination of care capabilities among patients third-party payers and risk evaluation and mitigation strategies or rims certified healthcare provider wage.

The distribution process with a new Hub to coordinate the rims requirements and we conducted the initial evaluation of health benefits available from third-party payers and utilize digital portal the simplified 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 offers some degree of coverage for probuphine.

We implemented a comprehensive Regulatory and compliance program. We rolled out new healthcare provider caregiver and patient education programs. And we grew the number of certified health care providers from you feel.

I'm very pleased with our team's progress during 2019, especially given the resource constraints that we as a company have faced subsequent a year. Anyway, we strengthened our balance sheet via registered direct offering and exercises of warrants. That wealth positions us to continue to execute on our growth strategy during the year.

An important 2019 Milestone was the European commission's approval of six votes, which is the brand name for the product in the EU establishing this as a home cooked meal will provide an update on this program in his closing remarks.

On the front we were very pleased to announce the National Institute for drug abuse has or nighters approval of second-year funding for our now machine program incapable provide more details on that in a few minutes.

Monday 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 a commercial activities in the progress that he and his team have made Dane.

Thank you very much. Mark 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 increase our sales force coverage fan as a result of the sales and marketing efforts. We have realized an increase in both coverage and the number of prescriber producing.

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 both of our field teams field sales Grim medical and hub to continue to provide the support and tools and treating oud.

As I mentioned we expanded our Specialty Pharmacy Network through a number of national Partnerships Alliance Rx Walgreens Prime Accredo Specialty Pharmacy a subsidiary of Express Scripts. And one of the largest US specialty pharmacy CVS Caremark a subsidiary of CVS health and among the largest prescription management pharmaceutical Services business office in the US.

We've also established a regional partnership with Southside Specialty Pharmacy, which has a strong presence in California and Texas. These two states are among those reporting the highest number of opioid-related deaths in the u.s.

We've improved our Hub patient services with a p and RX with minimal disruption to the supply chain and implemented a more efficient process that reduced prescription to product delivery time from three months to two weeks.

2019 also saw the launch of our step in the stability branding Campaign which highlights the unique long-term treatment features of producing and included a healthcare provider portal and branded patient website to provide patients and their caregivers easier access and improve visibility to locating qualified Healthcare Providers. We also executed a federal Supply schedule pricing agreement that went into effect January 15th, 2020 and has a five-year term.

We are currently established establishing a virtual training program for VA clinicians who elect to add probuphine to their oud treatment protocol for VA beneficiary and others within the federal system offering another solution to our veterans and need recently. We expanded our sales and marketing people 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 accomplish accomplishments to date at the end of 2016. We had 282 active prescribers and the number of active Health Care Providers continues to steadily increase we achieved broad product access to a comprehensive product distribution Network and by utilizing strategic partnership, we continue to see growth and prescriptions with an 18.6% increase in Q4 versus Q3. We significantly reduce 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 rate. Do not adequately or fairly odd inverse health care providers for these procedures often times costing them more out-of-pocket than the maximum allowed.

this may

I'm fairly prevent patients from receiving the appropriate treatment. We are actively trying to engage CMS to have a Frank and honest discussion regarding fair and accurate reimbursement with key opinion leaders.

While we sell 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 prescribed producing the option to have Rim 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 team that include medical rims complain and marketing. This model is currently under a soft launch in select geography with the goal of rolling out Nationwide by your end and was created with the goal of removing another potential hurdle for patients and clinicians alike as Mark mentioned. Our commercial activities have been impacted by covid-19 crisis may have the majority of commercial organizations around the world and white of our rapidly changing environment. We moved very quickly to protect our employees and our customers as long as well as support our providers so they can continue to serve their patient by training our field sales team to work remotely via the phone. We quickly quickly pivoted our commercial wage.

to ensure clinicians and patients have unfettered access to producing we updated our existing plans to quickly and thoughtfully bring on highly skilled talent in life is of reimbursement operation marketing PR telemedicine and implemented several support initiatives in all of our key channels as well as needed new senior sales professional who can now support any office patient or caregiver in the country via virtual mean

Finally, I'd like to share my thoughts in light of the covid-19 pandemic probuphine value proposition continues to grow and improve as the call to action from 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.

Going to call over to our chief scientific officer Doctor Who will discuss Titans progress on our medical Affairs drug safety and compliance functions as well. As our own product development and Regulatory activities as Mark mentioned. We were pleased to announce that Nida approved approximately 6.1 million in second year funding for our analysis and development program for the prevention of opioid relapse following detoxification.

The aggregate potential expense reimbursement to tighten is approximately 8.7 million which provides funds for the completion of implant formulation Development Office GMP manufacturing and the non-clinical studies required prior to commencing in 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 non clinical development plans and obtaining their guidance regarding regarding filing and ing application by the end of this year or in early 2021.

In other program development activities we continue to collaborate with the Walter Reed Army Institute of research or w r a i r and Southwest Research Institute for swri in the early non clinical evaluation of the primary platform for malaria prophylaxis.

The early data from this collaboration is encouraging and w r a i o a i r has received additional funding from the Department of Defense to continue the program with addition a non clinical testing of the typical on and proguanil implant formulations in large animal studies. W r a i r is also pursuing additional grant funding of testing other compounds that have shown promise as prophylactic treatment for malaria, and we look forward to collaborating with both w a r & S W E Y for the preparation of these implant formulations, which if successful could be available to us for potential commercialization.

Now shifting to are producing activities our medical Affairs and Drug safety compliance team has been focused on providing probuphine training and certification to health care package from across the country during 2019. We attended multiple professional conferences to raise awareness of probuphine and we were very pleased with health care providers interested participation in training sessions. We've also been focusing our resources on providing medical and rims training support to the commercial team and we will continue to do so.

No.

Turn on our last call. We have postponed the phase for studies in an effort to preserve our resources, and we have discussed our plans with the FDA in a conference call last quarter month 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 opiate use disorder patients people with opioid use disorder comprised one of the most vulnerable populations at risk for morbidity and mortality during this pandemic home, not only from covid-19, but from their underlying addiction and other potential, the diseases, so it's critical that people who need medication assisted therapy like produce 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 Pratap.

patient access to evidence-based treatment

at the request of the Substance Abuse and Mental Health Services Administration or Samsung the drug enforcement agency DEA announced that it would Grant an exemption form telemedicine to be used in place of initial in-person visits.

I've spoken with some of our Beauty and health care providers who have informed me that they are now using this new treatment Paradigm effectively while we evaluate how this may change after our business. We are working rapidly to ensure that the insertion and removal procedures are not very ER zerbo's Health Care Providers and patients during this difficult time. We're in the process of developing a virtual training program. So Health Care Providers can can continue to be trained to prescribe and administer producing and we are also creating specialty treatment clinics for patients near receive probuphine safely during the current or 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 progress over the next several months now. I'll turn the call to Brian to discuss Titans 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'll 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 dollars in Revenue.

This included zero point two million dollars from product sales.

1 million related to our night a grant

this

Compares with one point two million in Revenue during the same period a year ago, which was comprised of two million in product sales point three million related to the amortization a deferred revenue related to the sale to any of the European intellectual property rights of producing and point seven million related to the night of Grant.

Total revenues for the year ended December 31st 2019 were three point six million which includes three million and license revenues.

1 million from sales of Peruvian 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 and license Revenue point five million from 6. So for bluefin and point seven million related to our night a grant

the three million dollar decrease resulted primarily from non-recurring recurring license revenues in 2018 of 3.2 million in upfront and Milestone payments any and 2.1 million related to reacquiring the rights to prove uthan during or probuphine from our former licensee wage was partially offset by increased as in product revenue of five million in Grant revenues of 1.6 million.

And 3 or 3 million of license Revenue which represented the remaining amortization of the 2018 Martini upfront payment during 2019.

For the fourth quarter total operating expenses consisting primarily of R&D and sg&a expenses and costs of goods sold inclusive distribution expenses or five million.

Compared to 4.5 million in the same quarter in 2018.

Total operating expenses for the full year were twenty point five million in 2019 compared with 14.9 million in 2018 and consisted primarily of our own expenses are the expenses for the year ended December 31st, 2019. We're 7.3 million compared to seven point five million in 2018 ct6 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 night of Grant in 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 previews and ordering and distribution Network off and increased expenses associated expanding Titans for beef and Commercial activities.

The net loss applicable to Common shareholders in the fourth quarter of 2019 was 4 million or 8 cents per share.

Compared with a net loss of 3.5 million or 29 cents per share in the same quarter in 2018.

The full year for the full year 2019 our net loss was 16.5 million or 72 cents per share compared with a net loss of 9.3 million or share for 2018.

At December 31st 2019 we had cash and cash equivalents of five point two million dollars, which we believe along with the net cash proceeds of eight million dollars received from home of January 2020 offering and the exercise of warrants during the first quarter of 2020 are sufficient to fund our plant operations into the fourth quarter of 2020.

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

Thank you Brian. So let me Begin by providing a summary of our activities with our two partners and I teraputics in Canada and multi-faith in Europe.

During this past year Nike was focused and obtaining product pricing approvals and formulary listing from the provincial Health authorities. And I hear the provinces of New Brunswick, Newfoundland, Nova Scotia and Manitoba joined Albert Einstein Saskatchewan wage and providing access to probuphine as a treatment for opioid use disorder and eligible patients.

Night 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 will take any walk-ins the next steps towards commercialization of the product 6mo, which is the trade name for probuphine and Europe specifically applying for registration 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 mall Taney to plan the manufacturing of the buprenorphine and plans that will meet a new regulations. This has required some modifications to the facility at our contract manufacturer and the qualification of the modifieds sylheti is nearing completion with production scheduled very shortly.

Caution however, with the coronavirus spreading across the we're all monitoring the day-to-day changes in the work environment and hoping that the production package and San Antonio will remain on schedule. Also, we hope that more Taney 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 kids and testing as planned to enable the schedule product launch activities. 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 are probably seeing real on strategy and with a lot of hard work from our team and our partners we had made good progress.

While the product Revenue in 2019 of about a million dollars average the same Pace as the second half of 2018. We now have the infrastructure in place.

With the strength and balance sheet, we're well positioned to expand and support our commercial operations and continue streamlining. The Specialty Pharmacy did not process expanding training to mid-level Providers such as nurse practitioners and Physician's assistants.

Through targeted marketing efforts reach out to additional health care providers who have a patient population undergoing buprenorphine maintenance treatment month.

I am pretty clearly excited about implementing the 45 patient support model that day and described.

And utilizes the stress of the trained and qualified Healthcare 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 that 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 Healthcare Providers choose the wrong treatment approach with long-acting products like probuphine.

The same study during 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 implant project is progressing with the team working diligently to get all the non-clinical data necessary to file an intj hopefully by the end of this year and we thank Nike for their ongoing support.

Our management and the board recognized the shareholders sentiment and are being careful to use the limited resources wisely and keep expenses within our means month.

Including a six-month fifty percent reduction in marks and my salaries. What are the same time maintaining an environment for growth of our business?

A word of caution. However, we are somewhat uncharted waters at the present time with the rapidly changing environment created by the coronavirus Thursday. 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 opened the call to questions. I'd like to thank Titans Ford executive management and staff for the continued hard work and dedication during this difficult time.

We are ready to take questions from the call part assistance.

We will now begin the question-and-answer session. You will need to pick up the handset before pressing the keys to withdraw your question, please press * then two at this time. We will pause moment momentarily to assemble our roster.

And our first question comes from Anita of Zacks investment research, please go ahead.

Hi, good afternoon. First of all, I just want to say that I'm filling in for John today from blacks and please pass on the congratulations to dr. Barney on Thursday appointment to the board just have a couple of questions here. I know you already entered a few probably fine was recently added to the Federal Supply schedule or do you have any resources that show how many veterans comprised of the addressable market for probably fine.

Hi Anita, thank you for calling 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 and those suffering with or you need that are part of the VA system. No dane has looked at that specific population. Then 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 you know, those those specific numbers. I haven't seen those published yet. But it looking at you know, what we need from the from the data sources that are available. We know that it is significant. We we can reach over nine million veterans. Uh, but nine million is not the full impact it by oud. We have it. We 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 range.

And the general population so we know that which is one of the reasons why we we wanted to contract appropriately with the government was to ensure access wage 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 that is what we have at the moment. Okay and Who besides the VA might pull from the schedule?

With the FSS is the Federal Supply schedule. So any any, you know Tricare any federal agency that utilizes the the FSS could potentially have that access to producing they would just have to put that, you know, obviously get trained and then put the request in the normal procedures to get the reimbursement.

Okay, okay and regarding the pricing discussions 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?

Hi Anita, in in terms of pricing in Europe, you know, really small Taney handles that directly off while I'm aware of generally the level of pricing that they expect to get which, you know will be somewhere probably in the range of 40% or so less than the pricing that's typical of European pricing policies in their home. It is quite in a substantially higher than let's say the uh currently available treatments in Europe the stage in a multi me has focused initially on the two three countries wage.

The the expectation of pricing is higher because of the typical Healthcare systems that they have such as Germany UK and and and you know, that's where it they will be able to establish an appropriate price provide the perfect into those markets and show the benefits of the product and that allows the product to be, you know, appropriately spread through the rest of Europe. So it's a very odd staged approach that will be taken as they go forward. But once the first two or three country pricing is said it it creates the environment where they you can actually spread into the other regions of Europe with very specific Targets in mind and and use Partners who already have boots on the wage.

I'm going to can do the work with you. So that's the kind of strategy that expect. Multi me will be following that truly maybe what in one of these calls, you know, obviously with actually being really die early affected by the current endemic but maybe in the next six months one of the calls we will have in our partners from all thoene participate and provide some guidance as well. Okay? Okay. Okay, my other question related to the active prescribers you probably mentioned in the call and maybe I missed it. But you said there were two hundred eighty-two active prescribers as of end of 2019. What was kind of your target number? You're looking at it that you were working towards this year.

Yep, original Target at the middle of the year. When we started looking at this we said well, we really would like to have you know, a hundred active prescribers for various reasons the and where we are at the state is that the phone number that they mentioned but we still are continuing to grow so we will see in and we'll get to the five hundred numbers. I've no doubts about it, but we are looking at establishing as we said certain models that will help expedite that process especially with the ability to utilize in a sort of decentralized process for the insertion and removal of the implants. Yep.

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 prescribed it and use the services of these and that way we can expand the number of active Health Care Providers a lot faster. I mean the other things that Damon and his team has learned and they're trying to not change the Paradigm to implement ways where we can move faster. Okay? Okay, and and what are kind of the approval rate for the prescription request?

And when you say approval rates in terms of the processing through third-party payers is that yes.

You want to you want to address that yeah, so we have excuse me. We have about 94% coverage on the medical benefits side effects of drug. It depends on patient benefits, but we have a very high uh-huh. I guess success rate in terms of approval. It's it's upwards towards 70% off but it really is dependent upon the individual patients benefits many states. They they reduce the the barriers the Pas and the steps other wage 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 it really is dependent on every individual patient.

benefits as as with any medication

Right, right. Okay. Okay, and 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? Yeah, they you know, you were going for the online telemedicine kind of thing off.

Okay, so we have a physician portal that 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 that's uh a firewall private area. But we do we do have other metrics that we plan on uh-hum with internally before providing publicly within uh with Sonoma team and and off but for those those those prescriptions and the way the Physicians utilized portals, those are for the most part, you know firewall from from us and from the public you can okay? Okay, great. Thank you so much for answering the question.

Great. Thank Senator our next question comes from Jason McCarthy.

I want to add a bond the line for Jason just had a question here. You mentioned earlier on that day for post-market clinical trials have been temporarily temporarily off on on hold and light of the covid-19 pandemic. Could you shut some color on when you expect to reinitiate these trials?

Sure, you know, I mean, I I think the clinical studies there were three and one of which we actually will participate in life to have been postponed. But I let let Kate give you some color around that.

Okay. Yeah. Hi. Hi Jace. Can you hear me? Okay. Yeah, so we we have to we got to post-marketing clinical studies that are 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 a plantation into the lower abdomen a different giving clinicians and Alternate sites. And that's a a pharmacokinetic study small study. Another study is a larger study and that's looking at implants safety in a large observation cohorts. Now these studies are as all clinical studies are expensive and we are conserving our choices right now until the time is is right when we can initiate them. We have been in regular communication with the FDA regarding the study time lines and the FDA so far as being very strong.

That's the third study is a cardiac safety study that we have been asked by the FDA to collaborate with some of our our other companies in a parking 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 off. We will be starting that study. I don't know what kind of impact the current endemic environment may have on the study time lines as you can imagine doing a clinical study in an age of extremes social isolation and perhaps even quarantine is really challenging especially when you have to do a surgery for her subjects. So we'll keep you updated as we figure all of that that out.

And that's that's really all I can say at this point about those studies.

Okay know for sure that's definitely understandable difficult to to you know, give them the times that work for in right now. Yeah another quick it's not a point of clarification here earlier on you mentioned that you guys saw an 18.6% increase in active prescribers compared to 3 to 19. Is that correct?

Dang, you want a Android that the percentage of prescriptions? Yeah that probably referring to.

Yeah the increase in.

Can you say the question again, please?

Oh it just a point of clarification. I just wanted to make sure I got to the number down correctly here. You mentioned that you guys saw an 18.6% increase in active prescribers 2019 compared to 3 to 9. Is that right? Now? Those were the actual prescriptions that prescription? Yes. Yes, correct. The enrollment. Yeah in Rome the prescription increased. Excuse me, 18.6% in Q4 versus Q3.

Okay, great. Thanks a lot. I appreciate it. Sure.

Thanks, Dave.

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

Thank you Andrea. And thank you all for participating in this call appreciate very much your taking the time at this somewhat difficult times that 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 preneur technology during this pandemic month. Thank you very much and have an excellent day.

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