Q4 2021 Titan Medical Inc Earnings Call

[music].

Greetings and welcome to the Titan Medical Inc. fourth quarter and year-end 2021 financial results conference call and webcast. At this time, all participants are on a listen-only mode. A question and answer session will follow the formal presentation.

Greetings and welcome to the Titan Medical Inc. Fourth quarter and year end 2021 financial results conference call and webcast. At this time all participants are in a listen only mode. A question and answer session will follow the formal presentation.

If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Christian Galfetti, Vice President of Investor Relations. Thank you. Please go ahead.

If anyone should require operator assistance during the conference. Please press star zero on your telephone keypad. As a reminder, this conference is being recorded it is now my pleasure to introduce your host Christian <unk> Vice President of Investor Relations. Thank you. Please go ahead.

Thank you operator, good morning, and thank you for joining us for tightened medical here in earnings Conference call. Early this morning, we issued a press release summarizing the fourth quarter and year end financial results for 2021 and business highlights a copy of the release can be found in the Investor Relations section of our website at Www Dot tightened Medical Inc. Dot com.

Christian Galfetti: Thank you, operator. Good morning and thank you for joining us for Titan Medical's Year-End Earnings Conference.

Christian Galfetti: Earlier this morning, we issued a press release summarizing Titan's fourth quarter and year-end financial results for 2021 and business highlights. A copy of the release can be found in the Investor Relations section of our website at www.titanmedicalinc.com.

Christian Galfetti: As a reminder, certain statements made during this conference call constitute forward-looking statements that reflect management's current expectations of the company's future growth, results of operations, performance, and business prospects and opportunities.

As a reminder, certain statements made during this conference call constitute forward looking statements that reflect management's current expectations of the company's future growth results of operation performance and business prospects and opportunities.

Forward looking statements involve significant risks uncertainties and assumptions many factors could cause the company's actual results performance or achievements to be materially different from any future results performance or achievements that may be expressed or implied by such forward looking statements, including without limitation. Those listed on the caution regarding forward looking statements and risk factors section.

Christian Galfetti: Forward-looking statements involve significant risks, uncertainties, and assumptions. Many factors could cause the company's actual results, performance, or achievements to be materially different from any future results.

Christian Galfetti: performance, or achievements that may be expressed or implied by such forward-looking statements, including without limitation those listed on the caution regarding forward-looking statements and risk factors section of the company's annual report for the fiscal year ended December 31st, 2021, as well as the assumptions discussed under the section titled development plan from the company's recent MD&A, each of which may be viewed at cedar.com and at thefdc.gov.

I'm the company's annual report for the fiscal year ended December 31, 2021, as well as the country.

Under the section titled Development plan.

These recent MD&A each of which may be viewed at Cedar Dot com.

Dot Gov.

Please read our forward looking statements and Bruce cautions and the section in today's news release announcing our financial and operating results and be guided by their content, making investment decisions or recommendations. The release is available at www Dot tightened Medical Inc. Dot com.

Christian Galfetti: Please read all forward-looking statements and risk cautions in these sections and in today's news release announcing our financial and operating results and be guided by their content in making investment decisions or recommendations. The release is available at www.titanmedicallinks.com.

With that I will turn the call over to Paul can't afford it.

Christian Galfetti: With that, I will turn the call over to Paul Catiford, Plight Youth Interim President and Chief Executive Officer.

President and Chief Executive Officer.

Paul.

Thank you Christian good morning, and welcome to tightened Medical's fourth quarter and year end 2021 financial update call.

Paul Catiford: Thank you, Kristen. Good morning and welcome to Titan Medical's fourth quarter and year-end 2021 financial update call. Also joining me on the call today is Stephen Lemieux, our Chief Financial Officer.

Also joining me on the call today is Steven <unk>, our Chief Financial Officer building.

Paul Catiford: Building upon accomplishments we discussed on prior quarterly calls, we are pleased to share with you today details of our progress and updates on what we see on the horizon for Titan.

Building upon our accomplishments we discussed on prior quarterly calls we are pleased to share with you today details of our progress and updates on what we see on the horizon for Titan.

Paul Catiford: Past several months, we have had our heads down, focused on getting the Eno Single Access Robotic Assisted Surgical Platform ready for an investigational device exemption application with the FDA. As discussed in recent presentations, the FDA marketing authorization of the Eno system using a de novo pathway is a multi-step process.

Past several months, we have had our heads down focused on getting the email single access robotic assisted surgical platform ready for an investigational device exemption application with the FDA as discussed in recent presentations the FDA marketing authorization of the email system using a de novo pathway is a multi step process.

We are confident in our understanding of the process and have resourced and partnered with benchmark with productive effect. We remain on track with our previously disclosed timeline and are looking to file the <unk> application in Q1, 2000, 22023 and commence human clinical trials after approval.

Paul Catiford: We are confident in our understanding of the process and have resourced and partnered with Benchmark with productive effect. We remain on track with our previously disclosed timeline and are looking to file the IDE application in Q1, 2023 and commence human clinical trials after approval.

Paul Catiford: In anticipation of clinical trials beginning mid 2023, we have started reaching out to clinical trial sites.

Anticipation of clinical trials, beginning mid 2023.

Reaching out to clinical trials sites, our employees and partners have worked hard to deliver on our mission to bring this innovative proprietary and differentiated platform to market.

Paul Catiford: Our employees and partners have worked hard to deliver on our mission to bring this innovative, proprietary and differentiated platform to market.

Paul Catiford: Our company goal of improving patient outcomes and meeting the demands of surgeons and hospitals through the introduction of the ENOS Single Access Robotic Assisted Surgical Platform drives all of us.

Our company goal of improving patient outcomes and meeting the bands of surgeons and hospitals to the interaction of <unk> shingle access robotic assisted surgical platform drives all of us.

During the fourth quarter of 2021 and over the past few months Titan has achieved several accomplishments that put a steps had steps closer to our goal, including the receipt of a final payment for Medtronic. After completion of the last milestone in Q4, a portion of the proceeds were used to retire a senior secured.

Paul Catiford: During the fourth quarter of 2021 and over the past few months, Titan has achieved several accomplishments that put us steps ahead, steps closer to our goal, including the receipt of a final payment for Medtronic after completion of the last milestone in Q4. A portion of the proceeds were used to retire a senior secured loan with Medtronic.

Alone with Medtronic.

He announced bench markets are capital equipment manufacturing partner had and are now in the process of having first production surging workstations and patient cards delivered over the summer. These units will be leveraged with our proprietary cameras and multi articulating instruments and load it up with the software prior to system validation and verification testing at our <unk>.

Paul Catiford: We announced Benchmark as our capital equipment manufacturing partner and are now in the process of having first production surgeon workstations and patient cards delivered over the summer. These units will be leveraged with our proprietary cameras and multi-articulating instruments and loaded up with software prior to system validation and verification testing at our Chapel Hill, North Carolina operations facility.

<unk> Hill, North Carolina operations facility.

We are currently building out our camera and instrument manufacturing capability and look to announce a new head of manufacturing operations before the beginning of the summer.

Paul Catiford: We are currently building out our camera and instrument manufacturing capability and look to announce a new head of manufacturing operations before the beginning of the summer.

Paul Catiford: We have expanded our patent portfolio to more than 200 patents and applications. This IP portfolio continues to grow. We're continuing to evaluate options for geographical expansion and revenue generating opportunities with third parties. The company's comprehensive robotic surgery intellectual property portfolio includes coverage in the United States, Europe , Canada, China, Japan, Korea, and Australia.

We have expanded our patent portfolio to more than 200 patents and applications.

The portfolio continues to grow we're continuing to evaluate options for geographical expansion and revenue generating opportunities with third parties. The company's comprehensive robotic surgery surgery intellectual property portfolio includes coverage in the United States, Europe , Canada, China, Japan, Korea and Australia.

Paul Catiford: To be clear, while we have licensed some of our IP to third parties, we retain the right to the entire IP portfolio for our own use and our own products and services.

To be clear, while we have licensed some of our IP third parties, we retain the rights to the entire IP portfolio for our own use in our own products and services.

Paul Catiford: With respect to the NASDAQ notification regarding minimum bid price deficiency, we continue to evaluate all available options to resolve this deficiency.

With respect to the NASDAQ notification regarding minimum bid price deficiency, we continue to evaluate all available options to resolve this deficiency.

Paul Catiford: We also announced the CEO transition, where I have taken the role of Interim President and CEO . We have already started a formal CEO search process using a top-tier recruiting firm and are hopeful for a transition later on this year.

We also announced the CEO transition, where I've taken the role of interim President and CEO . We have already started the formal CEO search process using a top tier recruiting firm and are hopeful for a transition later on this year.

In addition.

Deepak Basra, our VP of strategy and business development and Chris <unk>, Our VP upstream marketing attended the society of American gastrointestinal and endoscopic Surgeons sages annual meeting last week.

Paul Catiford: Deepak Basara, our VP Strategy and Business Development, and Chris Siebert, our VP Upstream Marketing, attended the Society of American Gastrointestinal and Endoscopic Surgeons, SAGEs, annual meeting last week. In addition to updating surgeons on our latest advancements, they looked at innovations in advanced software.

In addition to updating surgeons on our latest advancements they looked and innovations in advanced software.

Finally, I presented and participated in the HC Wainwright and company buyout connect 2022 Investor Conference in January and then open <unk> 32nd annual Investor Conference earlier. This month, both both presentations are available on our website.

Paul Catiford: Finally, I presented and participated in the H.C. Wainwright and Company BioConnect 2022 Investor Conference in January and in Oppenheimer's 32nd Annual Investor Conference earlier this month. Both presentations are available on our website.

Paul Catiford: Our timeline to marketing authorization at the Eno system remains unchanged since we updated investors last fall.

Our timeline to marketing authorization of the email system remains unchanged since we updated investors last fall.

Paul Catiford: As we progress on our timeline, we continue to mitigate against risk.

Progress on our timeline, we continue to mitigate against risks we are proceeding with plans for marketing authorization utilizing that de Novo classification request pathway as a result of discussions with the FDA using the productive and informative Q submission facility.

Paul Catiford: We're proceeding with plans for marketing authorization, utilizing the de novo classification request pathway as a result of discussions with the FDA using the productive and informative Q submission facility.

Paul Catiford: As mentioned, the company plans to file the IDE application with the FDA in the first quarter of 2023 and anticipates receiving a response on the IDE from the FDA in the first half of 2020.

As mentioned the company plans to file the IDE application with the SBA in the first quarter of 2023 and anticipates receiving a response on the <unk> from the FDA in the first half of 2023.

Paul Catiford: Following IDE approval, we expect to start the IDE human clinical study in the second half of 2023. We anticipate, given information currently available to us, that our IDE study will include total laparoscopic hysterectomies performed on 30 to 40 patients at three to four clinical sites.

Following IDE approval, we expect to start the IDE human clinical study in the second half of 2023, we anticipate given information currently available to us that our IDE study will include total laparoscopic hysterectomies performed on 30 to 40 patients at three to four clinical sites upon completion of the clinical.

Paul Catiford: Upon completion of the clinical trials, we plan to submit a de novo classification request with the FDA in 2024. Commencing launch of the E-mail system, oh, I'm sorry. Commercial launch of the E-mail system will begin upon receipt of marketing authorization from the FDA anticipated in early 2025.

Trials.

Plan to submit a de Novo classification request with the FDA in 2020 for commencing launch of the email system, Oh, I'm, sorry, commercial launch of the email system will begin upon receipt of marketing authorization from the FDA anticipated in early 2025.

Paul Catiford: Our timelines remain unchanged from what we have previously disclosed during our Q3 2021 update. I am happy to report the team is executing extremely well. They are focused, properly resourced, and ready.

Our timelines remain unchanged from what we had previously disclosed during our Q3 2021 update I am happy to report that team is executing extremely well, they're focused properly resourced and driven.

Paul Catiford: Our partnership with Benchmark, our capital equipment contract manufacturer, is going well and on track to have the first production workstations and patient carts built this summer.

Our partnership with benchmark, our capital equipment contract manufacturer is going well and on track to have the first production workstations and patient cards built this summer.

Paul Catiford: We will run these systems through extensive verification and validation testing with results all being incorporated into our IDE application. We continue to build out our in-house manufacturing facility in Chapel Hill where we will assemble our proprietary cameras and instruments.

Randy systems through extensive verification and validation testing with results all being incorporated into our <unk> application.

Continue to build out our in house manufacturing facility in Chapel Hill, where we will assemble our proprietary cameras in instruments.

Paul Catiford: Although we are not currently impacted by world events, including the Ukraine-Russia conflict, COVID variants and supply chain issues, we continue to monitor this rapidly changing environment and put contingency plans and mitigations in place.

We are not currently impacted by world events, including Ukraine, Russia conflict, Covid variance and supply chain issues. We continue to monitor this rapidly changing environment and put contingency plans and mitigation in place.

Paul Catiford: a long-term outlook for our company and our shareholders range positive and optimistic.

The long term outlook for our company and our shareholders remains positive and optimistic we believe that the proprietary and highly differentiated single access robotic assisted surgical platform will be a game changer, our intellectual property portfolio continues to grow and partnerships like the recently concluded Medtronic development and license.

Paul Catiford: We believe that the proprietary and highly differentiated single-access robotic-assisted ENL surgical platform will be a game-changer.

Paul Catiford: Our intellectual property portfolio continues to grow and partnerships like the recently concluded Medtronic Development and Licensing Program independently validate our role as a leading innovator in single access robotic assisted surgery.

The program independently validate our role as a leading innovator in single access robotic assisted surgery.

Looking at the email system U S market opportunity tightens initial clinical focus will include benign gynecology surgery for the U S market. We believe this patient population is particularly motivated to embrace our single access surgical solution as it aligns with the patient's needs and demands reduce.

Paul Catiford: Looking at the Enal System U.S. market opportunity, Titan's initial clinical focus will include benign gynecology surgery for the U.S. market. We believe this patient population is particularly motivated to embrace our single-access surgical solution as it aligns with the patient's needs and demands. Reduce trauma to the body, faster healing, minimize scarring, and fewer pain medication.

Trauma to the body faster healing minimize scarring and fewer pain medications.

Paul Catiford: We anticipate the next area of clinical focus will be urology and natural extent.

We anticipate the next area of clinical focus will be urology and natural extension as you see on this slide based on independent market research conducted in 2021 and company estimates there are approximately 900000 rash and non res gynecology and urology procedures performed in the U S annually, we are targeting to capture.

Paul Catiford: As you see on this slide, based on independent market research conducted in 2021 and company estimates, there are approximately 900,000 RAS and non-RAS gynecology and urology procedures performed in the U.S. annually. We are targeting to capture 5% market share, expecting 225 annual procedures per ENO system per year, and we calculate a long-term value, or LTV, of approximately $4 million per system.

5% market share expecting 225 annual procedures per system per year, and we calculate the long term value or LTV of approximately $4 million persistent.

Paul Catiford: Based on recently completed market research and our own financial calculations, we believe we'll offer investors a risk-weighted return on their capital investment.

Based on recently completed market research and our own financial calculations, we believe will offer investors a risk weighted return on their capital investment.

Moreover, <unk>.

Based on our wide range of preclinical studies, we anticipate that the versatility of the email system could be very attractive for broad use in multiple sub specialties. We plan to work closely with our surgeon Advisory board and other leading surgeons to obtain feedback and insights regarding opportunities for us to satisfy other unmet needs.

Paul Catiford: Based on our wide range of preclinical studies, we anticipate that the versatility of the E-mail system could be very attractive for broad use in multiple subspecialties. We plan to work closely with our Surgeon Advisory Board and other leading surgeons to obtain feedback and insights regarding opportunities for us to satisfy other unmet needs.

Paul Catiford: Stephen and I will continue to participate in investor conferences and meet with institutional investors as part of our increased investor outreach activities.

Kevin and I will continue to participate in investor conferences, and meet with institutional investors as part of our increased investor outreach activities.

Paul Catiford: We have strengthened our relationships with health technology journalists developing Titan's narrative for the ENO system and how we see it positively impacting patient outcomes, providing a heightened ergonomic alternative to surgeons and improving hospital economics.

Strengthened our relationships with all technology journalists developing tightens narrative for the <unk> system, and how we see it positively impacting patient outcomes, providing a heightened ergonomic alternative to surgeons and improving hospital economics.

I will now turn the call over to Steven Lemieux are Steve <unk>, Our Chief Financial Officer to review our financial results Steven.

Speaker Change: I will now turn the call over to Stephen Lemieux, our Chief Financial Officer, to review our financial results.

Thank you Paul in the following discussion of results. Please note that all numbers are in U S dollars.

Stephen Lemieux: Thank you, Paul. In the following discussion of results, please note that all numbers are in U.S. dollars.

Stephen Lemieux: As of December 31st, 2021, we had cash of $32.3 million.

As of December 30, <unk> 2021.

Had cash of $32 $3 million.

Subsequent to the yearend, we received $8 $3 million from Medtronic for the achievement of the final milestone.

Stephen Lemieux: Subsequent to the year end, we received $8.3 million from Medtronic for the achievement of the final milestone, and we retired our debt.

Tyler does that.

Stephen Lemieux: Including this payment from Medtronic, our cash balance at year-end would have been $40.6 million.

Including this payment from Medtronic, our cash balance at year end would have been $46 million.

Stephen Lemieux: We anticipate that our cash on hand will fund operations into Q1 2023.

I think that our cash on hand will fund operations into Q1 2023.

Our operating cash burn was $36 6 million in 2021, approximately $9 million per quarter.

Stephen Lemieux: Our operating cash burn was $36.6 million in 2021, approximately $9 million per quarter.

Stephen Lemieux: In 2021, the company raised $44.2 million in cash from the equity offerings completed in January and February .

In 2021, the company was $44 2 million in cash from the equity offerings completed in January and February .

Stephen Lemieux: from the sale of common shares to aspire capital under the terms of a common share purchase agreement and from the exercise of warrant.

From the sale of common shares to aspire capital under the terms of the common share purchase agreement.

And from the exercise of warrants.

Stephen Lemieux: We have the ability to raise additional capital with Aspire by issuing 2.7 million common shares as per the terms of the share purchase agreement.

We have the ability to raise additional capital with inspire by issuing $2 7 million common shares as per the terms of the share purchase agreement.

R&D expenses were $10 8 million in the quarter and $37 9 million for the full year in 2021 compared to $5 5 million in Q4, $2027 9 million for the full year in 2020.

Stephen Lemieux: R&D expenses were $10.8 million in the quarter and $37.9 million for the full year in 2021 compared to $5.5 million in Q4 2020 and $7.9 million for the full year in 2020.

R&D expenses in 2021 were related to the development of the <unk> system and the development activities under the agreement with Medtronic.

Stephen Lemieux: R&D expenses in 2021 were related to the development of the ENO system and the development activities under the agreements with Medtronic.

Stephen Lemieux: Comparatively, in the first half of 2020, the company temporarily suspended R&D activities.

Comparatively in the first half of 2020, the company temporarily suspended R&D activities.

Stephen Lemieux: and then following the execution of the Medtronic agreements in June , initiated the establishment of in-house development capabilities in Chapel Hill, North Carolina.

And then following the execution of the Medtronic agreement in June .

Initiated the establishment of in House development capabilities in Chapel Hill, North Carolina.

G&A expenses were $12 4 million for the year ended December 31 2021.

Stephen Lemieux: G&A expenses were $12.4 million for the year ending December 31, 2021, compared to $7.6 million in the comparative period.

Third to $7 6 million in the comparative period.

The increase in G&A expenses in 2021 compared to 2020 was primarily related to an increase in stock based compensation costs of $2 6 million.

Stephen Lemieux: The increase in G&A expenses in 2021 compared to 2020 was primarily related to an increase in stock-based compensation costs of $2.6 million and $0.7 million.

Zero point $7 million in severance costs.

In 2021, we also expanded the senior leadership team to support the development and commercialization of the <unk> system and conducted market research.

Stephen Lemieux: In 2021, we also expanded the senior leadership team to support the development and commercialization of the ENO system and conducted market research.

Stephen Lemieux: adjusting for non-cash stock-based compensation expenses and one-time severance expenses.

Adjusting for non cash stock based compensation expenses, and one time severance expenses.

Stephen Lemieux: G&A expenses for 2021 were $8.1 million compared to $6.5 million in 2020.

<unk> expenses for 2021 were $8 1 million.

To $6 5 million in 2020.

G&A expenses increased to $2 million for the three months ended December 31, 2021, compared to $1 4 million for the three months ended December 31 2020.

Stephen Lemieux: G&A expenses increased to $2 million for the three months ended December 31, 2021, compared to $1.4 million for the three months ended December 31, 2020.

Stephen Lemieux: The increase in G&A expenses was related to $0.5 million in severance costs and an increase in stock-based compensation.

The increase in G&A expenses was related to zero point $5 million in severance costs and an increase in stock based compensation.

Stephen Lemieux: Titan's accomplishments in 2021 were remarkable.

<unk> accomplishments in 2021 were remarkable.

Stephen Lemieux: We added experienced professionals to the management team. We remediated material deficiencies in our financial controls. We clarified the regulatory process and realigned our product development timeline.

Having experienced professionals to the management team in.

We remediated material deficiencies in our financial controls.

Clarify the regulatory process and realigned our product development timeline.

Stephen Lemieux: We have added employees with excellent experience, strengthening our engineering department.

Other than employees with excellent experience strengthening our engineering departments.

Stephen Lemieux: We have resourced our regulatory affairs team and our quality assurance group.

<unk>, our regulatory affairs team and our quality assurance group.

The finance team has instituted controls processes and software programs to streamline and improve accounting procedures to be more efficient.

Stephen Lemieux: The finance team has instituted controls, processes, and software programs to streamline and improve accounting procedures to be more efficient.

We continue to focus on the financial health of Titan.

Stephen Lemieux: We continue to focus on the financial health of Titan to finance the ENO system through the de novo regulatory pathway.

Finally, the system through the de Novo regulatory pathway.

Stephen Lemieux: These are all significant accomplishments for Titan and support our continued growth as we shift from product development to manufacturing the Eno systems for use in the planned human clinical trials and commercialization. With that, I will now turn the call.

These are all significant accomplishments for Titan and support our continued growth as we shift from product development to manufacturing systems for use in the planned human clinical trials and commercialization.

With that I will now turn the call over to Paul.

Thank you Steven we believe that the email surgical system will address a high demand segment of the robotic assisted surgical device market. We remain committed to our current timeline to file an IDE submission for the <unk> system. In Q1 2023, we believe the email single access.

Stephen Lemieux: Thank you, Stephen. We believe that the e-mail surgical system will address a high demand segment of the robotic-assisted surgical device market.

Stephen Lemieux: We remain committed to our current timeline to file an IDE submission for the E-NOS system in Q1 2023. We believe the E-NOS Single Access Robotic Assisted Surgical Platform will offer a differentiated solution to what is available today.

Robotic assisted surgical platform will offer a differentiated solution to what is available today.

Stephen Lemieux: We look forward to keeping you informed on Titan's progress. We'll now open the line.

We look forward to keeping you informed on Titans progress.

Now open the line for questions operator.

Thank you the floor is now open for questions. If he would like to ask a question on the phone you May press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue. You May press star two if he would like to remove your question from the queue for participants using speaker equipment, they may be necessary to pick up your handset before pressing the star keys.

Speaker Change: Thank you. The floor is now open for questions. If you would like to ask a question on the phone, you may press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Once again, that is star 1 to register a question at this time.

Once again that is star one to register a question at this time.

Speaker Change: Our first question is coming from Siraj Kalia of Oppenheimer. Please go ahead. Good morning, Paul. Stephen, can you hear me?

Our first question is coming from Suraj Kalia of Oppenheimer. Please go ahead.

Good morning, Paul.

Alright.

I can hear you great. Thanks.

Siraj Kalia: perfect hope everyone is safe and healthy. Hey Paul, so when do you expect a design free

Perfect, Okay, everyone is safe and healthy.

So.

Design free.

Paul Catiford: What is the weakest link for achieving this milestone, and is it a function of the...

What is the weakest link for achieving this milestone.

Yes.

The R&D resources for that.

Paul Catiford: for that or is there a more fundamental issue at hand?

Instead of a more fundamental issue.

Yeah, yeah, Okay. So I mean design freeze.

Speaker Change: Yeah, yeah. Okay. So, I mean, design freeze, you know, for the whole system, you know, that won't occur until, you know, just before we file the item.

For the whole system.

Yes.

Won't occur till just before we file the IV, we have a number of sub components subsystems, and so forth and they go through various stages of design freeze.

Speaker Change: We have a number of subcomponents, subsystems, and so forth, and they go through various stages of design freeze and so forth. You could have some findings in your B&B testing that you might have to make some modifications to software, for example. You have to keep some doors open, but I would say that we've got now a dedicated project management office with three people on it now, and they're running through all the various components and subsystems.

And so forth. So you could have some findings in air Bnb testing that you might have to make some modifications to software. For example, so you have to keep some doors open, but I would say that we.

Got now a dedicated project management office.

With three people on it now and they are running through all the various components and sub systems.

Speaker Change: A complete design freeze sometime in the fall and a subsystem design freeze throughout the whole process.

But yeah complete design for you sometime in the fall and sub system design freeze throughout the whole process.

Got it.

Speaker Change: got it. One additional question from my side, Paul, and I'll pop back in queue. You mentioned, you know, 5% share in urology. Forgive me if I got that wrong. And also the ENOS, the idea is to have it differentiated to what's out there today. So presumably you're referring to the SP.

Just one question from my side I'll, let others hop back in queue.

You mentioned, 5% share in urology forgive me, if I've got that wrong.

So.

The he knows the idea is to have a differentiated to what's out there today, so presumably you're referring to the SP.

Speaker Change: And I'm curious if you could just parse out your comments in terms of, you know, what.

And I'm curious if you could just parse out your comments in terms of what.

Specific differentiation you're honing in on.

Speaker Change: specific differentiation, are you honing in on patient cohorts, geographies, just give us the next level of detail to the extent that you can talk about it would be greatly appreciated.

Patient cohorts geographies.

The next level of detail to the extent that you can talk about that would be greatly appreciated gentlemen, thank you for taking my questions.

Alright, well, thank you for the call.

Speaker Change: Well, thank you for the call. Just soon after joining the board in October of 2020, we commissioned a study with a well-known, well-regarded independent consult. They had looked at all the various different markets and so forth. Working with Perry Genova and some of our senior executives defined certain markets and certain

Yes.

Soon after joining the board in October of 2020, we commissioned a study with a well known and well regarded independent consult and they had looked at all the various different markets and so forth and then working with our with working with <unk> and some of our senior executives defined certain markets and certain certain.

Speaker Change: certain areas where our system was optimized. We targeted hysterectomy, gynecology type of procedures, followed by urology procedures.

Areas, where our system is optimized.

We chart, we targeted hysterectomies gynecology type of procedures, followed by urology procedures and the feedback from that came that really from from some of our surgeon Advisory Board members and so forth they were telling us that and I mean it just.

Speaker Change: And feedback from that came really from some of our Surgeon Advisory Board members and so forth.

Speaker Change: They were telling us that, and I mean, it's just beyond my capabilities, Raj, but they were telling us that the way the system has multi-articulating instruments, small volume for operating in, et cetera, the camera positioning and camera.

Beyond my capability Suraj, but they were telling us that the way the system as multi articulating instruments at small volume for for operating in et cetera.

Positioning and camera.

Speaker Change: are just all optimized for those types of procedures and the market sizing information came out of this study that was completed for the Board of Directors.

Just all optimized for those types of procedures and then market sizing information came out of this out of this study that was.

Completed for the board of directors.

Speaker Change: I hope that answers your question. We'll have more detail on market and market opportunities and how our system is specifically optimized for those.

Hope that answers your question, we'll have more detail on market and market opportunities.

Opportunities in how our system is specifically.

Optimized for those procedures and those markets.

Speaker Change: procedures and those markets as we start to build out our commercialization plan.

And the next as we start to build out our commercialization plan.

Fair enough. Thank you.

Thank you at this time I'd like to turn the floor over to MS Golf, Eddie for web submitted questions.

Speaker Change: Thank you. At this time, I'd like to turn the floor over to Ms. Galfetti for Web-submitted questions.

Okay.

Thank you Donna.

Christian Galfetti: We have a couple questions regarding the original Medtronic development and license agreement. We know that Titan met the milestones and Medtronic licensed probably one-third of the patents. We don't know what the co-development was and what the development agreement included. Could you expand on that?

We have a couple of questions regarding the original Medtronic development and license agreement.

We know that the tightened met the milestones and Medtronic licensed probably one third of the patents. We don't know what the co development was and what the development agreement included could you expand on that.

Yeah, Yeah, I mean, obviously the.

Speaker Change: Yeah, I mean, obviously the the the agreements with Medtronic are all bound by confidentiality and so forth. I could I could share that, you know, co-development and so forth really was related to the patient cart technologies and components connected to the patient cart.

The agreements with Medtronic are all bound by confidentiality and so forth.

I could I could share that.

Co development and so forth really was related to the patient cart technologies and components connected to the patient.

Okay. Great next question is the company currently entertaining option of a reverse split.

Speaker Change: Okay, great. Next question, is the company currently entertaining the option of a reverse split?

Speaker Change: As we've disclosed to the market, we have a NASDAQ stock price deficiency issue that needs to be remedied by June the 28th. We're looking at a number of alternatives to remedy this stock price deficiency issue, which also include reverse stocks, but we're looking at all alternatives.

Yes.

As we have disclosed to the market we have in NASDAQ stock price deficiency issue that needs to be remedied by June 28, and we're looking at a number of alternatives to remedy this stock price deficiency.

Issue and which also include a reverse stock split, but we're looking at all alternatives.

Speaker Change: and does Medtronic still have a non-voting member on the board? If not, when did that person leave?

And does Medtronic still have a nonvoting member on the board.

When did that personally.

Speaker Change: Yes, so the Medtronic board observer rights were linked with the Medtronic loan, and so the observer rights were terminated with the repayment of the NDT loan in early January .

Yes, so the Medtronic can board observer rights were linked with the Medtronic loan and so the observer rights or terminated with the repayment of the NDP loan in early January .

And you've talked about your building in assembly and cameras and instruments in North Carolina, just wondering why benchmark wouldn't be building everything.

Speaker Change: And you've talked about your building and assembling cameras and instruments in North Carolina. Just wondering why Benchmark wouldn't be building everything?

Yes, so I mean.

Speaker Change: The original statement of work and so forth was for capital equipment with Benchmark and

We just the original statement of work and so forth was for capital equipment with benchmark and we've already developed some proprietary manufacturing techniques and so forth related to the instruments that proprietary instruments and camera. We just find we're more nimble agile to be able to do it in house and we've got a pretty.

Speaker Change: We've already developed some proprietary manufacturing techniques and so forth related to the instruments, the proprietary instruments and camera.

Speaker Change: We just find we're more nimble and agile to be able to do it in-house and we've got a pretty solid manufacturing team and capability.

Solid manufacturing team and capability at Chapel Hill to make that happen.

Speaker Change: at Chapel Hill to make that happen. Let's be clear that we are sourcing components from local vendors and so forth. So we're doing a lot of assembly, final assembly, packaging, testing at our Chapel Hill facility.

Let's let's be clear that we are sourcing components from from local vendors and so forth. So.

We're doing a lot of assembly final assembly packaging testing.

I like her at our Chapel Hill facility.

And as a follow on to that what do you have the ability to produce elements for other companies.

Speaker Change: And as a follow on to that, will you have the ability to produce elements for other companies that have licensed your technology?

That have licensed their technology.

Absolutely.

Speaker Change: Absolutely. The instruments at the digital end are unique and so forth, but at the CDU, the central drive unit end, the part that connects into the patient cart, that could be open-ended. We could easily adapt our instruments and cameras to other types of interfaces.

The instruments.

At the distal end R. R.

Our unique and so forth, but at the CDU, whether its central drive unit and part of that connects into the patient Kurt you know that could be open ended that's we're looking at that we could easily adapt our instruments and cameras to other.

Other types of interfaces.

Excellent.

Speaker Change: Excellent. What is the strategy for attracting new licensing deals? Is there a team dedicated to selling the marketing and IP portfolio to increase the chances of securing another agreement?

What is the strategy for attracting new licensing deals is there a team dedicated to selling the marketing IP portfolio to increase the chances of securing another agreement.

Agreement.

Speaker Change: Yeah, we actually have Deepak Basara, our VP of Corporate Development and Business Development. He's looking at a number of alternatives, and I think I mentioned that in our preamble call.

Yes, we actually have.

Deepak Basra, our VP corporate development and business development. He is looking at number of alternatives and I think I've mentioned that in.

Her preamble call.

As you search for a new CEO , what quality must he or she possesses and are you considering any one that you have worked with before.

Speaker Change: As you search for a new CEO , what qualities must he or she possess and are you considering anyone that you have worked with before?

Speaker Change: Yeah, we're considering all people for the position. We have a top tier recruiting firm that's conducting the search on our behalf, really targeting a, and we've mentioned this before at the CEO transition call way back in the late fall. We're targeting somebody that has knowledge, experience, and go-to-market. So we're looking for somebody that can move million-dollar-plus capital equipment into hostels in the U.S. So that would be the best profile.

Yes, we're considering all all are all people for the position we have top tier recruiting firm that's conducting the search in our behalf really targeting a and we've mentioned this before at the CEO transition call a way back in the late fall.

Targeting somebody that has knowledge experience and go to market. So we're looking for somebody that can move the million dollar plus capital equipment into our hospitals in the U S. So that would be that would be the best profile.

And is there a plan in place to encourage management and board of director members to increase their holdings of the stock.

Speaker Change: And is there a plan in place to encourage management and board of director members to increase their holdings of the stock?

Speaker Change: Yeah, absolutely. Soon after joining the board, we put in a board mandatory stock ownership policy in place and we're looking now at putting in a senior executive stock ownership policy in place. We've also created a restricted share unit plan and the nice thing about a restricted share unit plan is it gives

Yeah.

It's absolutely. So we have we put in place soon after joining the board we put in a board mandatory stock ownership policy in place and we're looking now at putting in a senior executive.

Stock ownership policy in place. We've also created a restricted share unit plan and the nice thing about restricted share unit plan as it gets.

Speaker Change: senior executives, officers, and directors the ability to acquire stock outside of stock blackouts. All of the directors take all of their long-term incentives.

Senior executives officers and directors the ability to acquire stock outside of stock blackouts.

And so.

The number of directors all of the directors take all of their long term incentive and restricted share units and we have a.

Speaker Change: in restricted share units and we've a number of senior executives are also taking

Number of senior executives are also taking some of their component up there.

Speaker Change: some of their component of their compensation, long-term and short-term, in these restricted share units. If you monitor the CD site, S-E-D-I, for insiders, you'll see that the acquisition of these RSUs, they're all documented as they're required, and we'll be putting together some specific disclosure relating to RSU ownership in the company stock at our information circuit.

Compensation long term and short term in these restricted share units. If you. If you monitor the CD site S. E T I upper insiders Youll see that the acquisition of these are issues Theyre all documented as they're required and we'll be.

Putting together some specific disclosure relating to RSV ownership in the company stock at.

Our information circular when that gets published.

And regarding competitive environment can you put into context, how titan with its development timeline and other single access rads focused companies are aligned it seems as though you are ahead of the others.

Speaker Change: And regarding competitive environment, can you put into context how Titan, with its development timeline and other single access RAS-focused companies are aligned? It seems as though you are ahead of the others.

Yeah, I mean, it's we.

Speaker Change: Yeah, I mean, we haven't looked at specific timelines or specific timelines haven't been produced for some of our competitors. I mean, the intuitive SP platform has been out in the market for a number of periods already. And so right now, it looks like from the emerging group of competitors that we are ahead, but part of that was we committed to the de novo pathway.

Haven't looked at specific timelines or specific timelines hasn't been produced for some of our competitors.

Intuitive SP platform has been out in the market for a number of periods already.

And so right now it looks like from the emerging group of competitors that we are ahead, but part of that was we committed to the de novo pathway.

Speaker Change: earlier than some of our competitors. We've got a bit of a jump start on them and we have that timeline properly resourced now. We have a project plan that gets us to the ID submission in Q1 2023 and I talked about the other steps after that. We've got heads down and we're focused on

Earlier than some of our competitors. So we've got a bit of a jumpstart on them than we.

We have that timeline properly resourced now.

Yes.

Project plan that gets us to the IDE submission that Q1, 2023, and as I talked about the steps after that but where you've got heads down and we're focused on driving that project plan in that timeline.

Speaker Change: driving that project plan and timeline. I'm not sure what the competitors are doing or how they've resourced it, but I can tell you that we're going to make this happen.

Sure what the competitors are doing or how they researched it but I can I can tell you that.

We're going to make this happen.

Okay.

That wraps up the questions from the webcast.

Paul back to you.

Speaker Change: Well, great. Well, thank you, Kristen. Thank you, operator. In closing, I want to thank you for joining us on this call.

Great well. Thank you Christian Thank you operator in closing I want to thank you for joining us on this call. This morning, we remain focused on bringing our robotics single access surgical system to the market for the benefits of patients surgeons and hospitals. We remain very excited about the opportunity that lies ahead for Titan and we look forward to sharing our progress and.

Speaker Change: We remain focused on bringing our robotic, single-access surgical system to the market for the benefits of patients, surgeons, and hospitals. We remain very excited about the opportunity that lies ahead for Titan, and we look forward to sharing our progress and information with you over the next few months. Thank you, everyone.

Information with you over the next few months. Thank you, everyone and have a great day.

Ladies and gentlemen, thank you for your participation. This does conclude today's event you may disconnect your lines or log off the webcast at this time and enjoy the rest of your day.

Speaker Change: Ladies and gentlemen, thank you for your participation. This does conclude today's event. You may disconnect your lines or lock off the webcast at this time and enjoy the rest of your day.

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