TMDI - Earnings call transcript Q4 2020

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Operator

Good evening, ladies and gentlemen, and welcome to Titan Medical's Year-End 2020 Earnings Conference Call. [Operator Instructions] After the presentation, there will be an opportunity for call participants to ask questions.

As a reminder, today's conference is being recorded. I will now turn the conference over to Kristen Galfetti, Titan Medical's Investor Relations consultant. Please proceed.

Kristen Galfetti

Operator. you, Thank and Medical's everyone, for us joining Good XXXX thank earnings Titan year-end conference for evening, you call.

our which During at our results summarized earlier highlights, financial on copy be site, of Investor year-end Titan's release the in today. were release A call, we Web and Relations will key section www.titanmedicalinc.com. review our earnings issued press found can XXXX the business of

anticipated exciting and our and of improve million to on information current currently reporting, investor and end internal conferences events are know-how, based of beliefs during of As future budgets, in-house reflect gross this company's certain statements, regulatory a and made expect, conference of pathways that robust close of and similar expectations estimate, used expectation advancing our statements remediation reflect milestones, with manufacturing forward-looking Wherever these offering, been proceeds by possible, license with payments, results participate development to including $XX of business manufacturing, anticipate, for, as respect management's These constitute available in growth, may, of words February current XXXX, proceeds management. for plans controls financial plans identify and intend, to the such prospects the pipeline, management's will, opportunities. call processes statements our to assembly innovation future statements performance approximately expressions over believe, light net projected with as reminder, our use have preparation plans the certain operations, could, timelines respect planned, and and development would, to to plan, to statements. potential and forward-looking

at from significant implied should achievements more forward-looking assumptions Many results, be future Form or one vary www.cedar.com XX-F, actual cause or performance uncertainties, may any materially these risks, materialize company's the forward-looking different statements statements results. not to be achievements factors of made Forward-looking during by or considered which XXXX, statements. or company's dated implied uncertainties carefully on actual could may such be the or factors call. forward-looking statements Factors prospective from undue section should by and should at risks March Performance that expressed These those those assumptions. reliance materially prove results, viewed including, involve achievements conference forward-looking the and the statements the performance, annual www.sec.gov. on or in limitation, may or Risk this the incorrect, Should investors underlying place XX, be report or without expressed listed of and

Although actual those that based the achievements during President, cannot management conference assumptions, what be results, consistent Officer with are assure I With forward-looking statements. turn will performance prospective this that, be of and forward-looking Titan currently call the made Chief believes statements David? Medical. or reasonable to to Chairman, will call the McNally, company over upon investors Executive David

David McNally

the with year-end Titan I our I'd Good in evening, who surgical and to earnings thank support our Enos familiar shareholders robotic work who welcome want to to to for our everyone are single-access shareholders and our Titan thank Medical's their supportive to you, importantly, Medical, new to XXXX and Kristen. quarter fourth Thank call. Most want belief new develop I story. system. are Titan welcome and like

and milestones. of fundraising a that payments in world. health veterans different any Directors all establishment and the great Medtronic Titan team, of the Titan and as experienced year. are members we past Vice President and and in Titan stronger around With practices development of of forward position. last rapidly resulted Delorme, COVID-XX, together agreements, successful Chief our these on past, financial with and accomplishments, our improved directors, XXXX, and forward strengthened as appreciate portfolio, for company. and Titan the our Perry hope all leadership substantial emerged spite We Genova, execution Titan execute Senior completely Development, Board our of And Medical resources, listeners any multiple our financial on and in of Chapel that Research believe policies, Officer. than with will progress the intellectual we're forward today able the activities made made good President of the activities, subsidiary license new all under Titan Financial and has North on new a individuals development team Medical's have the challenging during providing of Monique our independent in license we XXXX Medical Despite year, to agreements of Carolina, to addition focused Progress receipt in USA; time governance a me Hill, year growing strides Joining new industry in this three management position a and enriched XXXX. representing spirits of a call including be organizations the known those new history. is the challenges solid majority U.S. in property in rising substantial of the Board, an in our we move has that for that wish Frankly, proved

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benign clinical upon is appropriate focus initial Our market. regulatory include expected to clearances the surgery U.S. for gynecologic

resulting the anticipate use believe the regard, potential the that success, the our of and on application projected based attractive has that of system to in we in global millions the over regulatory In grow versatility robotic we to procedures share system of for Although appropriate surgical could that Enos in years. a clearances, be preclinical single-access for found with subspecialties. performed are annually, be ultimately procedures continue multiple coming numerous our which

we marketing correspondence regulatory order As not de the pathway the FDA via Assisted pathway applicants. system FDA's expectations on plan devices. surgical study but RASD is for likely Devices from clarify to all specific indicate single-access process Surgical the shared with and on December guidance the Titan, input to-date, our authorization. continue understanding in to is novo We and clinical towards or medical the our our our de to that it and expert Robotically FDA the application communications communications novo with Based Enos is novel robotic reserved for planned conversations XX, that the U.S. for with FDA our expected for consultants,

depth patent intellectual As an communicate XXXX on surgery-focused cleared property exciting the system from marketing progress expand an of year perspective, the we hands getting continue surgeons. pending. portfolio, we we robotic now XXX will global and and to do, intellectual to property includes which our over was Enos as continue patents and applications our breadth into for the of

$XX XXXX million remaining which license our Enos a May Under agreement and over Medtronic execution through September, Co additional anticipated with plus progress of surgical million and having payment license strategic October, been Medtronic received & into enter reached exchange and portfolio those payments agreements, from development an one-third $XX million, licensed ongoing We has the license exercise believe our pursuant Titan Titan on of warrants. under to agreements intellectual leveraged to representing also the a be million resulting in development certain relationship payments, robot-assisted are in $XX of portion portfolio of technologies. the to of to to-date. and respectively for through Titan of property, progress to approximately deal beginning about has to agreement. development a million the meet technology in We with commercialize with of use with initial the raised payment to Separately to rights approximately one-third resulted offering the generation million raised the $XX for of our surgical at worldwide the on $XX.X the and portfolio based of property for total a IP Enos payments to-date, we're future already XXXX, of technologies The our incorporation in Burton million well $XX from and two milestones of including Bloom and in of access an developed time, Medtronic license intellectual system, in of system. license milestone development bought milestone since million about and that agreements retains expected technology surgical $XX been $XX into with the the Medtronic XXXX well-positioned for the XXXX. all

for this expect week. subsequent of this proceeds Bloom to a $XX later month, gross earlier the announced also We with bought close offering offering deal Burton and million

the accomplishments in our policies on website of to Titan operations website who and Medtronic. to Living ease XXXX from the development provide in our the see robust of I'm for for and into turn Senior of communications, call development surgical Additional carried Enos Chapel navigation via launching to USA, Labs, Vice over Titan out Hill, and involving development with our Titan insight details. details and Genova, which President website journey input Perry of stakeholder ongoing the with continuous directors. and we're opportunity agreement the on to our in being team President through and proud activities those included product system, R&D governance enhancements Medical our provides updated investors, Medical to now Dr. licensing investors engage pursuant increased to for board and relating for corporate building will based Please communication

Perry Genova

pleasure David, a all is be and evening. you to you, addressing this it Thank of

We competencies Engineering, program exciting level environment. despite challenging drive successes surgery during in in augmented of established unprecedented technical a Electrical robotic of and Medical, pace. quality David As at an Chapel and based The we our had subsidiary software, risen to strength in Titan to mentioned, Hill, the year expertise and management. our U.S. continues innovation Mechanical technical past and our the areas the assurance has significantly many for

development in-house process we surgical camera the we and and Notably, that light advancement advancing pipeline the multi-articulated short, innovative in and Enos developing our know XD manage manufacturing. of of and continues systems. prepare for invest for an Additionally, enhanced processes camera system and XD are the key Definition the and and designs instruments we're how as as assembly improve In technologies exciting team performance High created manufacturing tooling instrument has innovation. technical our to to

Our simulation has the and product KOL strategy within respect evolved COVID-XX restrictions to imposed even labs, increased with input by evaluation continued precautions.

based evaluation Hill the leading proximity Our ideal some thought laboratories, hospitals. of and location States is Chapel United independent in top to on

surgical systems, team kinematics, already overlays and experience has reality reliability system for identifying electromechanical developing augmented surgeons. progress, informatics test and hardware and the display software development robot times opportunities for improve made to response implementing to simulation Our improve substantial

implementation our with continued robust training also have a suite. of simulation We

proceed program an to equivalent on year. of number as the through under presently Medtronic development coordinated programs We're committee planned joint regularly program continues of track May company. in milestone to steering to this and according development members Our License comprised Agreement achieve next are the plan the each of from a for

well to as team our applications of Living year call as of U.S. international our and of provides which with to look going join use portion recently the to the and innovation. and to that, now Labs, With on is our launched journey additional Medtronic to forward pleased review which over are via with patent Titan Enos the financial we expert our the opportunity CFO, issued Monique? Lastly, results. forward engineers past the licensed have patents updates accomplishments updates Delorme, Monique with very for available and all you motivated surgical our XX system. of sharing I'll XX press which turn a pending, I'm

Monique Delorme

of be the proud I'm and to earnings I'm to you, my member Thank you a Perry. the of call it's pleasure has my on in And executive capacity be to addressing very with Chief of date, what Financial all team. pleased Titan first accomplished Officer.

deal Medtronic. company's During the $XX.X $XX.X increased license exercise and XXXX, additional from proceeds, approximately offering, compared million to as closed revenue of and bought the the $XX of ever XX, net development had both with end February Titan Titan to which year ended December license equity cash company generated agreement of bought $XX XX, XXXX. by its million from a evidenced January and agreement, XX, company financing, allotment million XXXX. aggregate company a from received At received on $XX with The million equivalent a over $X.X from XXXX and full a XXXX. secured Based an expects of warrants $XX million million position an December $X.X first XXXX, million XXXX, million also million proceeds of approximately by subsequent net proceeds these option. amount gross million X% approximately cash XXXX, which exercise note. from announced of cash loan XX, million affiliate deal of January raised December $XX.X Since close warrants. senior of $X.X the XX, hand of at financing In XX, with has and a of the The Medtronic had promissory in the approximately additional December of also on exercise to from proceeds from had the the $XX.X on company of an

with license Perry Medtronic, established subsidiary, the generated secured during David our in of and and form agreements revenue our the the company have have U.S. important payments. As workforce ever earlier, which past has year, a first tripled noted

to operations. resources needs management the guiding bolster lost to and the accounting committee This through of this options maintaining for the not As accounting of U.S. and TSX and period of directors, and working new compliance company derivative the CFO accounting and warrants change, the requirements our NASDAQ. been with and audit and currency includes our responsibility both address our including country of board me. the financial rapidly complex changing the is related transaction systems Canadian remarkable operations, Together on and dual to financial listing with stock both we've

In relating we perform preparation expense, procedures in were for identified and to our controls our identified the release improve as for audit internal remediation a year-end in subcontractor noted weaknesses MD&A, reporting, a of large we we full the been in our financial to today's of our committee, made errors with ended support noted controls year-end. As in internal in during prior and has filing non-cash XX, weaknesses, evaluation year as our the relating particular of All reporting financial of MD&A. the statements warrants plans XXXX. robust audit, our identified at over financial material to such accrual MD&A management December cutoff over view developing to corrections non-cash derivatives as to and

complex call clinical a adding ERP to solid studies. expects for and accounting continued Enos team. our the material build progresses journey In identified relevant recently sheet as assist summary, with systems, information three David. our further more I and it with surgical business prepare financing Our capacity to matter the remediation recent well adopting fully Management as balance human include: to to of back on support turn we as to transaction, activities other outside activities through upon that, foundation system its subject company these will our the activities remediation development strengthen to growth. With engaging consultants weaknesses primary correct provide as an over

David McNally

We and to participation Currently, and Enos to those committed surgical address Enos' Monique. recovery including trauma market communicate on savings agreement look of remain we for to less And demand H. and Medtronic. the the We Bloom device surgical high robotic capital forward and investor the to Web believe XXXX believe single-access significant and to governance single-access faster several promising related standard we'll of corporate our robotic through Burton, surgical C. patient system and procedure robotic we ambulatory equipment, centers. global and continue our of keeping hospitals participate March, milestones releases, outreach. apprised not times, with and investor and cost in in ahead, Despite the license care will goal in to under-penetrated, but an Capital our ROTH system the surgical toward conferences, development progress segment including We upcoming news site, healthcare-focused investor assisted that that Oppenheimer, headwinds has it impacted surgery. you plan conferences. you, virtual Partners, become for virtual in Thank brought, April. fundamental Wainwright, and service,

in be these support. you publicly release participation via advance. in will announcing your Thank conferences for our We press

now will open questions. line up We for Operator? the

Operator

you. Thank

will be Thank Instructions] [Operator conducting now We a you. session. question-and-answer

comes first David from with Our question. question with Burton. proceed your Please Martin Bloom

David Martin

wondering I Hi is if an be and at you clinical idea just to you how trial? design us of was could start you'll of there. give Enos when the the final able think this point, the

David McNally

This McNally Thank is you, here. David. David

pursue to the improvements the refinements How our sterile expanding many input of made instruments, device subsequent surgical to KOL related the and to pathway patient us system, on We're get focus Enos we've we've to for overlays unit fast interface particularly that for central the surgeons has of. that to software that this that to and system, information work the of would including cart. authorization relates provide forward de for refinements we the how That plan the the clearance also focusing multi-articulating So, year, indicated the been of respect operation FDA some march received. to commercialization to to our with for can our on to classification expect of validations market more based spoke Dr. real-time the complete FDA the in market system. With and reality toward is the camera augment use the market, expect they doing planned we the that system. has Genova novo

We FDA be study with to expect those approval. clinical define our are to marketing continue for the that for going study to are the device the very exemption requirements; engage to further investigational important requirements application

application with plan after next investigational of approval current following device IDE the completing to year FDA XXXX. product expect exemption, under this the proceed in our surgeries and development Our year, human we is for

intend novo we we potentially estimates, current de of requisite successful clearance IDE the are And submit to the on could completion today, we from in Following based our launch follow-up, and studies to achieve XXXX. where commercially application.

David Martin

question Okay, answered. IP thank been other develops the beyond you, to Medtronic you One you. are not stand and it's But payments? own if that from they've if I'm robot with that sure milestone their royalties there licensed receive would the

David McNally

no are There the the payments and license associated under royalty the agreements. existing license are They provisions we agreements. developing are royalty-free payments technologies under with for that development

David Martin

intention their -- is is Medtronic to robot, their build is But Okay. that correct? own

David McNally

they is the diverges and from is Yes, therein its in vision vision it relationship that, we information certain that a platform Medtronic that see Titan's that a public robotic Hugo is we developing own ways in is have believe platform. And synergistic.

David Martin

Got you. it. Thank

Kristen Galfetti

And webcast. following couple the have along the company from considering… that, Is with a we questions

David McNally

Very good, Kristen.

Kristen Galfetti

Is Enos? breakthrough designation considering the status FDA's for company

David McNally

we're surgery acceptance growing. it executive for opportunity cleared positive we have and to meet is accessory that in-house system already ground note, designation We market, alternatives. to the surgery market in and designation, a On would robust on that with no to including that be that need. view have the fact determined exists achieving there single-port run appears And that growing in excited the very we as breakthrough serve there positive leadership unlikely a of that regulatory based single-port of breakthrough single-port that be a will requirements our the that and

Kristen Galfetti

Enos is with along planning to take the Titan market following And to that, themselves?

David McNally

our Presently, is system Enos in U.S. the launch particularly focus surgical to plan ourselves, the with

do assess value our with free we global as to so. that we of surgical ideal proposition, move However, to based partnering distribution potential our forward, the strategic and the established on well system, for as believe the and we'll we're market partnering simplicity Enos companies, continue opportunities as

Kristen Galfetti

other Could surgical Enos space? cover advantages system what to robotic Great. same systems the the offers in you compared

David McNally

surgical distinguishes market based the system orifice. in Enos the First, single-access years. or from This meaning surgical as the body a coming on system market single enters those the incision as today, a our it devices in natural robotic-assisted entry contemplated is through well architecture, most other that for a

approximation, a our dexterity appropriate cutting, of with provides unique other and of and and instrument include multi-articulated technology that combination surgical force maneuvers tissue tasks ease movement for Next, tasks. performing coagulation, suturing,

HD during which camera clear which safety well camera element a during for a HD camera with our anatomy as provides view exploration tube, in insertion in as and allows of operating flat initial the provides surgery, our Finally, target and dual-view camera, system two-dimensional of for a new our XD room. panel awareness endoscopic heads-up the situational display visualization surgery,

Kristen Galfetti

Great.

question, it Medical that could Titan sold possible Another Medtronic? be to is

David McNally

pursue think the about I'll of, It are options license would under however, company. agreement to certainly any for call be say, to that level. that free sort even premature the of move strategic can Medtronic I development it, strategic all we and

Kristen Galfetti

long how to to the expect you able question, balance the Another cash fund be company? do

David McNally

to turn like Monique to Monique? that one Delorme. I'd over

Monique Delorme

January button of question, after raise Titan I proceeds Sorry, successful mute XXXX, am into much my of very a getting has for David. Thank million, of from $XX year-end. million Kristen. also that exercise $XX.X the as I'm listening. In here warrants you just off received

anticipating our cash bring we related million close approximately Medtronic in the the two year. million another to deliverables will that's financing this meet $XX that So, in current we'll $XX week, expected the is next milestones this to later

fund really cash operations hand, proceeds including offering close Medtronic on this to that and our end licensed to of the the XXXX. current the week, current of plus at Our is going through payments, the should

in you. Thank we're shape. good So,

Kristen Galfetti

to well question, surgeon's different Enos' the ergonomic in as as importance enhancing benefits their dexterity talk regards the reducing surgeons of can you about little A for fatigue?

David McNally

time Perry, respect you. And both of over experience to feedback the lab, to been turn over to KOLs the deal ergonomics with gain of with dry and it firsthand and Perry, system. our of able to the wet to great I'll turn has one their like I'd Dr. he's that Genova and in a spent

Perry Genova

Yes, system thank system a Kristen. very you, Well, comfortable is And thank David. use. to you, first, the

We provider a I is robotic surgery, up and chair, have heads a which for understand unusual, it's system.

lean have box does in surgeon not the observe a So into manner. to that and

So, technology, able stay well ergonomics touch them not as they're on familiar as surgical comfort, being the longevity laser literature, only as for the to with what's in so in technology, XD The seeing surgeon with visual and we're provide periphery. the going in but around their careers, forth.

So, I'm very excited to bring new and people, new our use surgeons into system. assess

that And of thing to hand features entirety Another of system seem simplicity for up popular that the several our to with using of and any the pieces orientation Surgeons what explanation is the and the we need can surgeon pieces, console these found comfortable hand these last universally and natural surgeries therefore, are. pieces. the they're benefits about very not the hours.

So, question. thank it you addressed for I the appropriately. I've hope

David McNally

Labs Living say Yes, the Titan hand at that's more pieces? see and my opportunity to on and

Perry Genova

true. Yes,

Kristen Galfetti

most seeing addressed coming there's the questions more web. didn't that we've just think any I the if I'm cover. of from we

closing. that's think to for like good. turn David I back to over it I'd

David McNally

of today I'm is be on Well, the going refinements here together our in Chapel to Hill here. see engineering evolution, that It thrilling the team among are coming to delighted feeling here. buzz the what's

patients. vision and surgeons for about of look forward and for shareholders. our closing, of progress. and direct providing Titan of our Directors, that strong and for is solid the of a that keeping robotic joining all. of So, all our to support thank again single-access us and evening result Titan and the excited success commitment and I'd of believe Board have surgical We're Medical. of our We're leading-edge great validate proud footing and you in We the employees, leadership today benefit our again, your is support hard recognize governance, to a system of a progress, our of like future, you of to our informed work very the you the Thank on

Operator

conference. This concludes today's

for a evening. time. your wonderful you You lines may Have this at Thank disconnect participation. your

Titan Medical (TMDIF) 23 Feb 212020 Q4 Earnings call transcript