Achievement of milestone and receipt of $10
million license payment from Medtronic
Augmented Board of Directors and strengthened
leadership team
Progress on development activities to support
submission of IDE application to FDA
Titan Medical Inc. (Nasdaq: TMDI; TSX: TMD), a medical device
company focused on the development and commercialization of its
innovative surgical technologies for robotic single access surgery,
today announced financial results for the three and six months
ended June 30, 2021.
During the second quarter of 2021, the company made solid
progress under the development and license agreement with Medtronic
plc, strengthened its leadership team, expanded and diversified its
Board of Directors, increased its cash position, secured additional
intellectual property, and progressed activities toward filing an
IDE (Investigational Device Exemption) application with the FDA,
currently anticipated in the first quarter of 2022.
“Among our accomplishments during a highly productive second
quarter is the progress achieved by our rapidly growing engineering
team in Chapel Hill, recently evidenced by the successful
completion of a porcine hysterectomy and simulated hernia repair
using our Enos™ robotic single access surgical system. With this
foundational work competed, along with cash on hand to fund us
through 2022, and the recent additions to our Board of Directors
and leadership team, we are well positioned to execute on our plans
toward regulatory clearance and commercialization of our Enos
system,” stated David McNally, President and Chief Executive
Officer of Titan. “Additionally, the company enhanced its
development and manufacturing capabilities and expanded its
intellectual capital, adding to a growing patent portfolio, which
now comprises over 175 patents and patent applications. We believe
that our intellectual property portfolio, a subset of which we
share with Medtronic under a development and license agreement,
positions us as an innovation leader in robotic single access
surgery.”
“Looking forward, we are focused on clarifying expectations with
the FDA for human clinical studies, currently planned to commence
in the first half of 2022, and on the completion of the final
milestone associated with the Medtronic development and license
agreement, anticipated by year-end,” McNally explained. “Our vision
of commercializing a leading edge innovative robotic single access
surgical system in an underserved market is closer to being
achieved through recent progress and planned actions,” McNally
added.
Recent Company Progress and Future Activities
- Continued progression of milestone achievements with Medtronic
- Successful completion of the third milestone under the
development and license agreement.
- Final milestone is expected for completion by year-end
2021.
- Advanced product development in preparation of an IDE
Application with the FDA
- Expanded intellectual capital through the recruitment of
engineering talent and lease expansion to facilitate continued
innovation and in-house manufacturing of instruments and
cameras.
- Ricardo Estape, MD successfully completed an animal lab
hysterectomy and simulated hernia repair using the Enos system. Dr.
Estape’s interview can be viewed on the Titan Living Labs section
of Titan’s website here.
- Commenced biocompatibility testing of instruments, camera
systems and accessories.
- Planned commencement of Good Laboratory Practice studies in
September 2021 in support of the upcoming IDE application.
- Expansion of leadership team
- Stephen Lemieux joined Titan as Chief Financial Officer with
experience leading successful company financings, licensing and
M&A transactions valued at over $400 million.
- Tammy Carrea joined Titan as Vice President, Quality and
Regulatory Affairs having developed and implemented clinical and
regulatory strategies and successfully registering medical devices
including FDA De Novo applications.
- Deepak Basra joined Titan as Vice President, Strategy and
Business Development bringing his strategic and business
development expertise gained from multiple global firms including
Covidien’s vascular therapies division.
- Paul Cataford was named Chairman of the Board, from his
previous role as Lead Independent Director of Titan’s Board of
Directors.
- All existing board members and additional nominees were elected
as directors of the company at the Annual and Special Meeting of
Shareholders. New directors include Cathy Steiner, an experienced
investment banker and financial and capital markets advisor for
healthcare companies, and Heather Knight, a dynamic sales and
marketing executive with proven healthcare commercial experience,
including her current post with Baxter Healthcare and prior
position with Medtronic with the multi-billion dollar Surgical
Innovations business group.
- Strengthened financials
- Cash increased to $55.0 million in the quarter from the receipt
of the $10.0 million license payment from Medtronic and from the
receipt of $2.5 million from the issuance of common shares to
Aspire Capital Fund, LLC.
- Expanded R&D capabilities and intellectual property
- Increased footprint in Chapel Hill to support the expansion of
development and manufacturing activities.
- As of June 30, 2021, Titan holds 82 issued patents and 95
patent applications, with a growing portfolio in single access
robotic assisted surgery.
- Recent investor events (investor presentation can be viewed
here)
- David McNally and Stephen Lemieux participated in investor
meetings at A.G.P.'s Virtual MedTech Summer Conference.
- David McNally presented at the Oppenheimer MedTech Summit
Investor Conference.
Upcoming Virtual Investor Events
- H.C. Wainwright 23rd Annual Global Investment Conference,
September 13-15, 2021
- Oppenheimer Fall Healthcare Life Sciences & MedTech Summit,
September 20-23, 2021
- Cantor Global Healthcare Conference, September 27-30, 2021
Financial Highlights
As of June 30, 2021, Titan had cash and cash equivalents of
$55.0 million, compared to $25.5 million at December 31, 2020 and
$53.4 million at March 31, 2021.
Research and development (“R&D”) expenses increased to $7.1
million in the quarter compared to $0.1 million in the second
quarter of 2020. R&D is focused on the development of the Enos
system and development activities under the development and license
agreement with Medtronic. In the comparative period, the Company
temporarily suspended R&D activities. For the six-months ended
June 30, 2021, R&D expenses were $14.7 million compared to $0.2
million in the comparative period.
General and administrative (“G&A”) expenses were $4.8
million in the quarter compared to $2.4 million in the comparative
period. The Company adjusts G&A for non-cash and one-time items
such as stock-based compensation (“SBC”) and severance. Adjusted
G&A was $3.2 million for the quarter compared to $2.2 million
in the three-month period ending June 30, 2020. The increase is
primarily related to the expansion of the leadership team to
support the development of the Enos system and advancement of the
Company’s strategic initiatives. For the six-months ended June 30,
2021, Adjusted G&A expenses were $6.5 million compared to $3.6
million in the comparative period.
The Company’s interim financial statements and MD&A are
available at www.sedar.com and at www.sec.gov.
Investor Audio Webcast Information
Titan Medical will host an investor audio webcast at 8:30 a.m.
ET today (August 11, 2021) to discuss the company’s financial
results for the second quarter ended June 30, 2021, and recent
business highlights. The webcast can be accessed via the Investor
Relations section of the company’s website
www.titanmedicalinc.com.
Non-IFRS Measures
The Company discloses non-IFRS measures (such as adjusted
G&A expenses) that do not have standardized meanings prescribed
by IFRS. The Company believes that shareholders, investment
analysts and other readers find such measures helpful in
understanding the Company’s financial performance. Non-IFRS
financial measures do not have any standardized meaning prescribed
by IFRS and may not have been calculated in the same way as
similarly named financial measures presented by other reporting
issuers and therefore unlikely to be comparable to similar measures
presented by other companies. Furthermore, these non-IFRS measures
should not be considered in isolation or as a substitute for
measures of performance or cash flows as prepared in accordance
with IFRS. These measures should be considered as supplemental in
nature and not as a substitute for related financial information
prepared in accordance with IFRS.
Adjusted G&A
G&A refers to expenses determined in accordance with IFRS.
The Company defines adjusted G&A as G&A excluding SBC
expense and severance costs. Management believes adjusted G&A
is a useful supplemental measure to determine the Company’s cash
burn rate related to G&A so investors can understand the cash
that is available for research and development.
Three Months Ended Six Months Ended
June 30, 2021
June 30, 2020
June 30, 2021
June 30, 2020
$
$
$
$
General and administrative expense
4,837
2,389
8,903
4,059
Stock-based compensation expense
(1,429
)
(206
)
(2,197
)
(435
)
Severance provision
(171
)
-
(171
)
-
Adjusted general and administrative expense
3,237
2,183
6,535
3,624
About Titan Medical
Titan Medical Inc. (Nasdaq: TMDI; TSX: TMD), a medical device
company headquartered in Toronto, Ontario and with R&D
facilities in Chapel Hill, North Carolina, is focused on enhancing
robotic assisted surgery using innovative technology through a
single access point. The Enos™ robotic single access surgical
system is being developed with an ergonomic focus to provide a
surgical experience that imitates real-life movements that surgeons
demand and includes multi-articulating instruments designed to
allow surgeons an increased range of motion in a confined space,
with dexterity and the ability to exert the forces necessary to
complete common surgical tasks. With the Enos system, Titan intends
to initially pursue gynecologic surgical indications.
Certain aspects of Titan’s robotic assisted surgical
technologies and related intellectual property have been licensed
to Medtronic plc, while retaining world-wide rights to
commercialize the technologies for use with the Enos system.
Enos™ is a trademark of Titan Medical Inc.
For more information, visit www.titanmedicalinc.com.
Forward-Looking Statements
This news release contains “forward-looking statements” within
the meaning of applicable Canadian and U.S. securities laws, which
reflect the current expectations of management of the company’s
future growth, results of operations, performance, and business
prospects and opportunities. Forward-looking statements are
frequently, but not always, identified by words such as “may”,
“would”, “could”, “will”, “anticipate”, “believe”, “plan”,
“expect”, “intend”, “estimate”, “potential for” and similar
expressions, although these words may not be present in all
forward-looking statements. Forward-looking statements that appear
in this release may include, without limitation, references to: the
company’s focus on the design and development of surgical
technologies for robotic single access surgery; the company’s
anticipated filing of an IDE application with the FDA; the
company’s planned commence of Good Laboratory Practice studies; the
company’s focus on clarifying expectations for human clinical
studies and the commencement thereof; the company’s work under the
development and license agreement with Medtronic and the
anticipated completion of the final milestone under the agreement;
the company’s vision of providing an innovative robotic single
access surgical system in an underserved market; the company’s
intention to host an upcoming investor audio webcast; the company’s
focus on enhancing robotic assisted surgery using innovative
technology through a single access point; the Enos robotic single
access surgical system being developed with an ergonomic focus to
provide a surgical experience that imitates real-life movements
that surgeons demand; and that Titan intends to initially pursue
gynecologic surgical indications. These statements reflect
management’s current beliefs and are based on information currently
available to management. 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 in the “Risk Factors” section of the company’s Annual
Information Form and Form 40-F for the fiscal year ended December
31, 2020 (which may be viewed at www.sedar.com and at ). Should one
or more of these risks or uncertainties materialize, or should
assumptions underlying the forward-looking statements prove
incorrect, actual results, performance, or achievements may vary
materially from those expressed or implied by the forward-looking
statements contained in this news release. These factors should be
considered carefully, and prospective investors should not place
undue reliance on the forward-looking statements. Although the
forward-looking statements contained in the news release are based
upon what management currently believes to be reasonable
assumptions, the company cannot assure prospective investors that
actual results, performance or achievements will be consistent with
these forward-looking statements. Except as required by law, the
company expressly disclaims any intention or obligation to update
or revise any forward-looking statements whether as a result of new
information, future events or otherwise.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210811005422/en/
Kristen Galfetti Vice President, Investor Relations &
Corporate Communications +1-781-869-2553
investors@titanmedicalinc.com
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