Q2 2020 Titan Pharmaceuticals Inc Earnings Call
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Financial results conference call.
At this time all participants.
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There'll be a question and answer session. Following today's remarks.
Please be advised this call is being taped the company's requests and will be archived on the company's website starting later today.
At this time I would like to turn call over to you know closely president and CEO of Titan Pharmaceuticals. Please go ahead.
Thank you Sarah and thank you all for joining us.
Welcome to the Titan Pharmaceuticals calls to review financial and operational results for the second quarter ended June Thirtyth 2020.
And we provide an update on our business.
Before we begin I want it to inform you that we have filed quarterly reports on form 10-Q, with yes, we see and the press release issued earlier today provides a summary of the results can be found on our website at <unk> Dot com.
Joining me on the call today from tighten our Dr., Marc Rubin, our executive Chairman.
Dr. Gate D var names or executive Vice President and Chief Scientific Officer.
Probably vice President of finance.
We have show Shreyas.
Executive director of commercial operations, and Mike stretched our national sales director or joining us to provide a more detailed update on our probuphine sales and marketing programs.
Before we get into the details of the financial results and provide an update on the company.
Jennifer Carolyn will review the required to cautions regarding forward looking statements Jennifer.
Thank you for Neil 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 27 eight of the Securities Act of 933 and section 21. He is the Securities Exchange Act of 1934 fixed.
Eight months 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 that could cause.
Actual results could differ materially from management's current expectations include those risks and uncertainties relating to the commercialization of Probuphine, the regulatory approval process tightens ability to access capital.
Filament testing production and marketing of our drug candidates patents and intellectual property matters and strategic a week agreements and relationships.
We expressed we 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 statements is based except as required by law.
I'll now turn the call over to you Mark.
Thank you Jennifer.
Everybody. Thank you for joining us as always and I hope, you're all staying safe and healthy during these very challenging times.
We'd like to focus today is cool.
[laughter].
Proper suite made and implementing our sales and marketing programs and importantly substantial progress made in our recently established coke.
With energy.
Let me start by saying that the revenue growth we originally expected.
And used to be impacted by cobot 19.
Although we have expanded our commercial operations with additions to our sales and medical use on teams, which now provide coverage for all 50 states and Puerto Rico.
Cobot 19 related travel and social distancing restrictions have substantially impacted in person interactions between patients and their health care provider.
And have impeded the ability of our commercial team to operate with maximal effectiveness.
In response, we have undertaken a number of key activities to attempt to mitigate the impact of cold at 19 out of commercial business.
Including establishing relationships digitally with new health care providers in their staff.
Providing virtual communication tools for health care providers to use with their patients in order to highlight the potential benefits of Probuphine.
Establishing a social media presence to increase awareness of Probuphine.
And importantly, providing foley virtual rems training and certification to both new and existing health care providers in order to continue to grow the business.
Our new Copromotion partnership with India, Jean will help us achieve our current goal of rapidly expanding our outreach capabilities to the medical community and to patients.
By fully embracing a digital communications approach.
Using into genes digital communication platform last week, we launched the first campaign to educate healthcare providers about probuphine is value as a maintenance treatment option for select patients.
In addition, we are implementing a program that focuses on Oh, you de patients and their caregivers in order to assist in digitally connecting potential patients with Rems certified health care providers and with trained staff for follow ups.
There are patients at the efforts.
With the health care providers over the past you want our work.
Oh patient enrollments for Probuphine treatment began dropping off fairly rapidly in March and continuing into may.
Clinics in certain regions began to see an increase in enrollments in June which have continued.
And I will let Joe and Mike elaborate on all the commercial activities in just a minute.
But before I do I want to emphasize that any progress we make can be sustained only if our stockholders approved the proposal to increase the authorized shares at a special stockholder meeting scheduled for August 31st 2020.
Currently we need only 3.6% of the shares eligible to vote at the meeting to vote in favor in order to approve the increase.
More than one third of eligible shares have not yet been vote. It.
So I encourage all of our stockholders to vote in favor of this proposal, we are very close and to support Titan through its next phase of development.
And lastly, a and importantly.
I want to let you know that the Neil has expressed as this up its desire to retire by the end of the year if possible.
To prepare for this transition and of course contingent on our ability to raise additional capital.
We plan to look for a successor with broad commercial experience as we continue our transition to a commercial stage company.
Thank you all for your ongoing support during these challenging times and most importantly, please be safe and stay healthy.
And I will now pass the call to Joe who will discuss our partnership with into gene and our co promotion strategy Joe.
Thank you Mark and Hello, everybody.
Over the past several months recognizing the limitations caused by the cobot 90 pandemic, we've been adjusting our plans in activities to increase probuphine uptake and realize the value of having a comprehensive program for digitally driven product promotion activities.
You know, we recently entered into a Copromotion agreement with energy.
And the gene strength is partnering with companies throughout their lives brand lifecycle.
Providing additional commercial support.
I mean, leveraging its unique digital platform.
We are confident this partnership will help raise awareness of Probuphine among health care professionals inpatients dealing with opioid use disorder.
Soon after entering into the agreement in late June we established a core team of tightening in the genes there.
To exchange information on Probuphine and determine the quickest path forward.
You can match utilizing into genes digital capabilities to educate ichi piece and the merits of the product for maintenance treatment.
Oh, you de patients and encourage them to evaluate the use of probuphine in the clinics I.
I can confidently say that we've built a strong collaboration and have made significant strides in laying out targeted plans for the next several months.
We have established for strategic Imperatives dynasty. This important copromotion process. They are one.
Dr. Probuphine discussion at the point of care right HCP and the right patient.
To accelerate in dry Rems certification Ichi, Pease, who desire training and expressed a strong desire to use probuphine with rapid conversions prescription.
Three focus in capitalized on established hot spots, where we have existing business as well as a newly identified areas, increasing the reach and frequency and finally.
Identifying and partner with state initiatives, So real beauty becomes part of the discussion and more importantly, part of the solution.
The growing opioid crisis in the challenges of Cobot, Nike more states, you're allocating resources to this unmet need.
We've identified a target cool 51000, H.C. Pease, who have written prescriptions for you've been working products in the last 12 months.
20% of these accounts for 80% on the prescriptions. So we will allocate the bulk of our resources to this important group.
For the first 12 months of the partnership we are targeting 3 million impressions were every time and HCP or patient use probuphine content.
We anticipate 63000 engagements with the same audience.
First digital communication from the energy plant warm. So now last week was designed to raise the awareness of Probuphine with each she piece, we successfully reached 85% of our target audience with this kick off ticket.
Over the next several months, we will be launching additional new tactics geared towards EGPC patients. It will drive a probably you can discussion at the point of care.
Additionally, in the gene will be deploying for virtual representatives at the end of this month to optimize our reach and frequency.
I would now like to tell you bought another extending program. We started two weeks ago inpatient activation initiative.
This three months program is designed to drive motivated Oh, you do patients to Rems trained and certified providers treatment or do you think.
We have identified several key geographic areas with rents train EGPC and using social media. We can identify Oh, you de patients interested in learning about what do you see.
As a new treatment option.
Engagement involves a nurse coordinator speaking with an interest in patient to assess whether the individual qualifies for probuphine treatment.
Yes, the patient does qualified and is being treated buying HCP, who is not rooms train and nurse coordinator can't provide who have you seen education to the GP.
She Pete if the patient first and acquaint make can be scheduled with a provider who is already runs train.
This program is designed to match the right patient with the right H.C.P. the desire treatment.
Lastly to strengthen our commercial operations, we have been a barry evaluating or processes to ensure that we have optimal patient throughput.
Taking into consideration ample reimbursement support inefficiencies with our specialty pharmacy providers.
It is crucial is we work toward greater fulfillment and overcoming reimbursement challenges we have experienced.
I'd like to now turn the call over to Mike will provide an update on the sales teams activities Mike.
Thanks, Joe.
Much of the success that comes from implementing new programs initiatives like our partnership with into Jean Marc Our patient activation initiative, that's an effective execution by the sales team.
I'm proud to be count team is currently driving probably be patient enrollment.
Free Cobot 19 levels.
Demonstrating that we have deployed the right people the highly effective manner and ability to maximize the potential. These two critical new partnership efforts.
How about 19, it's presented many major challenges for OTI patients and providers.
Let me first speak to the peril of Yogi patient population.
Which is seen as much of the 20% increase in overdoses since the onset of the pandemic <unk>.
Presenting a significant underreported growing health care crisis.
The problem rooted in financial strain anxiety.
Our of health care facilities and exposure to the virus and overall increased and mental health issues.
These factors are keeping many patients or most in need of treatment from seeking.
The growing need for treatment that allows for quote social different thing because that's an opportunity for providers to an option like probuphine six month.
Treatment efficacy mitigates frequent access issues.
To address the challenging of informing educating and training providers on the value probably from durney I'm depend on it.
The account team has had to change the tactics to grow its provider based an increased usage probuphine.
On March 16, well the nation was broadly shutdown, we have neither we designed and implemented a virtual platform. There whats built to allow the accounting to remain productive and continue to be a resource to their customers.
The platform involved from phone calls to a suite of provider in patient tools, including video calls an educational meetings.
The virtual platform has allowed us to provide a level stability to the actually piece and the clinics that we work with the started result increased patient roll enrollments for the past few months in fact in July we makes pre cobot 19 level enrollments.
It's important to note. This achievement was made with only eight account managers and for medical liaison covering all 50 states in Puerto Rico.
Without the might have marketing programs, we're now implementing it within the gene and the patient activation, Michigan, We recently put in place.
As we move through July and into August we experienced an increase in request for health care provider in person visits.
These requests have largely mirrored the ebb and flow of Iresearch, then declines across the nation.
It's not the effort to the account managers went to be inquiry area. It's a great access.
The impact of in person visits had been immediate and measurable.
The focus itself going forward, it's on a continuous target refinement and leveraging the medical liaison team to highlight the value of Probuphine six month therapy, particularly for the most at risk of PD patients.
We expect the <unk> co promotion programs initiated indigent identify additional HCPCS, we'll need to be trained and certified under Rems program.
And our account managers will be coordinating managing these new accounts as well.
Based on the upward trajectory over moments, we believed that our expansive marketing expert efforts combined with improving patient provider access will increase probably of utilization volumes.
Let me now I'll turn the call over to Chief Scientific Officer, Dr. keep them Arnie, who will discuss tightens progress on medical affairs.
Like safety and compliance function as well as our product development regulatory activities Tate.
Thank you Mike.
Yeah, I cant she's meant for Titan during the second quarter with the FTC approval of our fully virtual rents training and certification program and this is now available to qualified health care providers at treatment centers across the U.S.
And these include qualified physicians nurse practitioners and physicians' assistants.
Our program enables us to continue to safely train and certify health care providers to both prescribed and administered have you seen drain the pandemic facilitating access for eligible patients with L. Eugene.
Justin Since June 14 health care providers have been trained via our ft. They approved fully virtual format.
13 of which have written prescriptions for producing.
And on average 80% prescriptions written result inpatient treatment. In addition since into genes initial push we have experienced an increase demand and interest for training from interest from health care providers.
Now I'd like to utterance, you are now machine implant development program for the prevention of opioid relapse following detoxification.
As you know nine at the National Institute on drug addiction.
Proved approximately 8.7 million in funding over two years for this program, providing the funds for the completion of implant formulation development as well as the GMP manufacturing and Nonclinical studies, which are all required while the I indeed.
[noise] after meeting with the F.D.A. during the first quarter. The agency specified is five to five be one regulatory pathway and additional Nonclinical studies required to file in I N G, which will delay filing to mid 2021.
We're making good progress with the I N D, enabling nonclinical studies.
Night It continues to support our efforts and I'm happy to report that they've accepted or plan to we allocate previously approved funds she conducting studies.
Finally, I'd like to provide a brief update on our plan to states where studies for Probuphine.
In the third quarter of last year, we decided to postpone these studies in an effort to preserve our resources we've been in contact with the FDA, who is confirmed that we may continue to delay our phase four study commitments pending sufficient resources.
That concludes my remarks for today and I look forward to keeping you updated on our progress within the next several months now I'll turn the call kitchen, Neil Neil.
Thank you Kate.
As you know we filed our form 10-Q would this second quarter financial results would be actually see today.
And the press release issued this morning provides a summary up those results.
Brian Crowley, our VP of finance is with us on the call today.
And during the Q when they period will be available to address any questions you may have.
I hope the information provided today gives you a better understanding of the actions taken over the last few months to overcome some of the effect on our business of the scope is 19 pandemic.
And we look forward to keeping you updated on the progress of tightens commercial initiatives.
I also want to provide you an update on our partnership with most thing.
Various and to make related restrictions have also in fact didn't multani and launching six small indeed you.
And has delayed the completion of work here in the U.S. to modify the manufacturing facilities and set up testing protocols to me you regulations.
We have completed all of this works now and manufactured product for Euro.
And expect this will be shipped to multani during the third quarter.
Well, if any is progressing with that plans for product launch in major you kind of trees and expect towards the end of this year or early next year to be able to start.
The marketing and sales process.
Hi, I'm extremely proud of like change quickly adapting to this new environment.
Today, you heard from show will discuss the four strategic imperatives, if our copromotion process with energy.
As well as our new patient activation initiative.
Mike gave you some information on the challenges posed by covert 19 in the field.
And how it's small but very dedicated team along with critical support from the medical Affairs.
As being able to bring patient enrollments back to free pandemic levels. This is a very important milestone for us and we believe we have.
The right tools now and on the right tried to keep progressing.
Finally take highlighted the FTC approval of a fully virtual rest program without which.
There was no way of continuing to.
Increase the number of certified and Crane healthcare providers. So this is very important for us and this was launched.
Last quarter nationwide.
We believe with these new programs in place and with the support a far Copromotion partner ended gene we are well positioned to continue to increase probuphine utilization.
I also want.
To remind you of course stockholders meeting, which is very important for us that's scheduled for August 31st.
Approval of in Threes and authorized shares requires only another 3.6% of be eligible shares to vote in favor of the proposals. So we're almost there but truly needs to support a feat.
Remaining shares and the.
Stockholders to vote.
With more than one third of eligible shares not yet vote, Dave we truly would like to encourage all our shareholders to vote in favor and support that's worth next phase of development.
This concludes our prepared remarks, but today.
And before I open the call to questions like Defense Tightness Board Executive management and staff for their continued hard work and dedication.
Please stay safe and healthy.
Sarah we are ready to take questions from the call participants.
Thank you we will not begin my question answer session.
To ask a question you May Press Star then one on your Touchtone phone.
If you're using a speakerphone please pick up your handset before prepping the key.
Withdraw your question. Please press Star then too.
At this time, we'll pause momentarily to assemble our roster.
Our first question comes from John Vandermosten, What's the please go ahead.
Good morning, everyone I wanted to start out with a question on a the timeline for the new relationship with into gene and see a when when first revenues are expected from out I mean, how many how many things do you have to get all lined up before those first come in the door.
Hi, John.
Thanks, and I Hope all is why wouldn't you too.
And Oh, the ER partnership within Digi and as you know we signed the agreement in late June.
It's a four year agreement.
And during the month of July.
The primary focus was on getting the teams working together educated oh, each other's capabilities, especially educating into gene on the details around Probuphine as you know with all of the reps controls.
And restrictions we have to make sure everything reuse is also you know a goes through a process would be PRC and so on within the company and.
I'm very pleased that within the month, they were able to take the material and start the first campaign, which started in the beginning far to focus.
At this campaign you know if they force so bovie as as Joe mentioned that he can for like some more detail a little later, if you need a there are several additional campaigns that will go on through the next few weeks.
As Phil mentioned, we're already starting to see some interest far apart from that from healthcare providers.
My goal or at least what we would like to see clearly this current quarter that third quarter. You know we have started to maintain that and get back to a stable level that was sort of free.
Oh varied.
Enrollment levels that is very important and we'll start seeing some growth from that to fund the following quarter.
Certainly.
And Joe and Mike maybe you can provide a little more detail on what we expect with a the following quarters.
Sure and so Neal this is Joe and what I'd like to add to what you've already said is.
Within the gene over the next three months or at least playing out to November we will lay out nine different types of tactics or we're moving in that aggressive pace.
And these are tactics that are gonna be geared towards HCPCS through email campaigns, a virtual sales reps that we already discussed social media campaigns in the same way of is going out towards the patients.
Because of one of the things that we came up with it for a strategic imperative is we need to get the right patient what the right HCP and we know when we get them together, we know that the patient will be well received the value of Probuphine show. This is all going to be accelerated and we would anticipate that we would see.
Significant improvement.
By fourth quarter.
As far as enrollments, which of course tie into revenue. So we're looking at approximately 50% in the fourth quarter increase over where we are right now.
Okay.
And <unk> are there any other similar products that the energy and has has advanced similar to to prohibition.
Yeah.
That's a really good question I I will say I mean this is what they do this is there will a this isn't there wheelhouse. They they take these brands regardless of where they are in their lifecycle and they provide their commercial muscle they can step in any way.
And they've done extraordinarily well.
I can't talk about specifics I mean, you can go to their website you can see all sorts of things are populated but they do it and they do would well.
John and they have stuff.
Oh go ahead I just wanted to mention that in terms of a product Cindy addiction space. This is the first product that they are working what.
They're very excited because they see this as they are areas that requires a lot more attention and and there is a required.
Yeah, that's a big.
Epidemic.
That they feel they can provide a lot of support for providing treatment. So.
It's the first one they're very eager and and interested in and in a putting all their best resources behind that because they see that says that they are major milestone for them as well. They have worked with both small companies with a specialty products and the continued to do so at this stage.
And as Joe mentioned, you know they have some listed on their web sites as well.
Okay, Yeah, I'll take a look at that and then the geographical or a provider type of focus.
I I didnt get that Uh huh.
Would you must have between sorry, sorry, yeah, I'll repeat myself do they have any any type of any geographical focus or and in their provider.
That there that they've developed relationships with.
I ended gene is actually a global company they started off in Asia in India.
They have presence in Europe.
China and the U.S.
And provide a support for both big pharma and small pharma in all of these regions.
ER and as Joe mentioned, I mean that products in different stages.
Lifecycle from early stage to Ah you know supporting.
Products that may be going off patent and so on but they are indeed, a global company.
More than 2000 people strong.
Okay, Great News and Neil This is Marc Rubin, a it can I just interject something a briefly <unk> Joe I made a comment that we expect I think 50% increase in the fourth quarter.
I want to make it clear that were not we don't we don't make specific projections that is absolutely a laudable goal.
I think you know the most important thing that we can say is that we expect to see.
Increases and meaningful increases in the fourth quarter.
So I just wanted to clarify that that that is not a specific projects that we're making.
Okay. Thanks Mark.
And I.
I noticed that a that there were some corona virus related delays in terms of shipping product to to Italy.
Is that might that also being issue for a Canadian partner as well or as is that something that's just overseas.
The requirement for Europe, and and meeting the specific Oh, you know you regulations require some modification in the facilities in.
ER and or Texas It DPT.
That's what.
ER and I've got affected because.
Availability of people to get there and get the work completed it was already on.
Being done when.
Okay.
Restrictions came about.
That.
Has been completed now it didnt directly affect product or in a specifications for the U.S. in Canada, but obviously restricted use of the facility to lift was completed we don't anticipate any issues with supplying product for U.S. or Canada.
In fact, Oh, we are actually.
Flattening a batch can be made shortly and so on so it's back punch.
Stream and continuing to make the product it was strictly a requirement for the E U regulatory site.
Great. Okay, well, thank you for answering my questions.
Thanks, Sean.
This concludes our question and answer session.
I'd like to turn the conference back over to you know does leave for any closing remark.
Thank you all for participating in this call as always we appreciate your ongoing support and we look forward to reporting action you progress with our.
Probuphine program as well as other products from from Euro So stay safe stay healthy and we look forward to talking to you against so.
Bye.
The conference has now concluded. Thank you for attending today's presentation you may now disconnect.