REG - Spectral MD Holdings - Trading Update

Spectral MD HoldingsAnnouncement

02/11/2022 07:17

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RNS Number : 9969E  Spectral MD Holdings, Ltd.  02 November 2022

 

Spectral MD Holdings, Ltd

("Spectral MD" or the "Company")

 

Trading Update

 

Spectral MD expected to exceed full year market expectations for revenue,
margins, and EBITDA

Burn and Diabetic Foot Ulcer ("DFU") clinical studies remain on track

 

LONDON, U.K AND DALLAS, TX, U.S. Spectral MD Holdings, Ltd. (AIM: SMD), a
predictive analytics company with proprietary AI algorithms and optical
technology for faster and more accurate treatment decisions in wound care,
announces an update on trading, which the Company expects will exceed current
market expectations for the year ended 31 December 2022, across revenues,
gross margin, and EBITDA performance.

 

Financial Update

The Company expects its 2022 grant revenue to be materially ahead of market
expectations and nearly 60% ahead of grant revenues received in 2021. This
translates to a significantly better Gross Margin than expected and a
considerably reduced EBITDA loss, with both ahead of market expectations.

 

Grant revenue, mainly deriving from the Company's BARDA funding contract for
the Burn indication, has been driven higher by strong execution of Burn
clinical studies and related developments of the contract in the second half
of 2022. The Company also received additional funding commitments from BARDA
of US$ 8.2m in August this year. This will allow Spectral MD to expand the
number of clinical trial sites, fund the development of DeepView's Electronic
Health Record (EHR) interoperability with hospitals and other sites of
service, and accelerate manufacturing readiness sooner than planned. These
funded tasks are expected to start earlier than originally expected and will
therefore contribute to the higher-than-expected revenue.

 

The Company's Gross Margin percentage is expected to be higher than market
expectations due to a different clinical study cost mix in the current year
than previously anticipated. The Company expects Gross Margins to return to
previous levels in 2023. Current trial costs are well within planned budgets,
reflecting tight cost controls, which should result in a better-than-expected
DFU R&D cost position in the current year.

 

Business Update

The Company has been executing the BARDA sponsored Burn clinical study with
ten leading US research hospitals across the nation. The enrollment for the
study has been strong and the Company is well on the way to meet the
enrollment targets for adult patients. For pediatric enrollments, the Company,
and the Company's BARDA sponsor both recognize the need for more sites to meet
the target, and this has been financially supported by the additional BARDA
funding of US$ 8.2m announced in late August 2022.

 

The enrolment completion of the DFU clinical trial in the US as well as the
initiation of the DFU clinical trial in Europe are on track for this year and
updates on progress will be provided in due course.

 

Wensheng Fan, Spectral MD Chief Executive Officer, said: "I am delighted to
report that we continue to make good progress on our clinical and regulatory
pathway, and that the financial performance of the business is exceeding
market expectations on all levels. 2022 is proving to be another exciting year
for Spectral MD and we remain focused on completing enrollment in both Burn
and DFU clinical studies and continuing to support an accelerated pathway to
commercial readiness."

 

 

Market Abuse Regulation (MAR) Disclosure

The information contained within this announcement is deemed by the Company to
constitute inside information as stipulated under the Market Abuse Regulations
(EU) No. 596/2014 as it forms part of UK domestic law by virtue of the
European Union (Withdrawal) Act 2018 ('MAR'). Upon the publication of this
announcement via Regulatory Information Service ('RIS'), this inside
information is now considered to be in the public domain.

 

For further information please contact:

 

 Spectral MD Holdings, Ltd.                                                      investors.spectralmd.com
 Wensheng Fan, Chief Executive Officer                                           via Walbrook PR
 Nils Windler, Chief Financial Officer

 SP Angel Corporate Finance LLP (NOMAD and Joint Broker)                         Tel: +44 (0)20 3470 0470
 Stuart Gledhill/Caroline Rowe (Corporate Finance)

 Vadim Alexandre/Rob Rees (Sales & Broking)

 Stifel Nicolaus Europe Limited (Joint Broker)                                   Tel: +44 (0)20 7710 7600

 Charles Hoare / Ben Maddison / Nick Harland /

 Will Palmer-Brown

 Walbrook PR Ltd (Media & Investor Relations)      Tel: +44 (0)20 7933 8780 or spectralMD@walbrookpr.com
 Paul McManus / Alice Woodings                     Mob: +44 (0)7980 541 893 / +44 (0)7407 804 654

 

 

About Spectral MD:
 

We are a dedicated team of forward-thinkers striving to revolutionize the
management of wound care by "Seeing the Unknown" ® with our DeepView(®)
Wound Imaging System.

www.spectralmd.com

info@spectralmd.com

 

 

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