REG - Convatec Group PLC - Convatec responds to LCDs postponement in US

ConvaTecAnnouncement

14/04/2025 07:00

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RNS Number : 8609E  Convatec Group PLC  14 April 2025

 

14 April 2025

 

InnovaMatrix sales outlook improved by postponement of Local Coverage
Determinations (LCDs) in the United States

 

Convatec welcomes the postponement by the Centers for Medicare & Medicaid
Services (CMS) of the LCDs for Skin Substitute Grafts/Cellular and
Tissue-Based Products for the treatment of Diabetic Foot Ulcers (DFUs) and
Venous Leg Ulcers (VLUs), which was announced late-afternoon UK-time on Friday
11 April 2025. This action by the US Administration means that Medicare
patients with DFUs and VLUs will continue to benefit from access to
InnovaMatrix(®).

 

InnovaMatrix(®) is an excellent product delivering strong real-world results
for patients and is trusted by clinicians. Convatec remains committed to
evidence-based medicine to improve outcomes for patients and choice for HCPs.
Our randomised controlled trials
(https://www.convatecgroup.com/media-articles/press-releases/2024/convatec_update_on_innovamatrix_ac_clinical_data_second_randomised_controlled_trial_authorised/)
(RCTs) in DFU and VLU are on track to report in 2026. These will complement
our published real-world evidence (RWE), including RWE published in December
2024 (https://pubmed.ncbi.nlm.nih.gov/39720774/) .

 

We believe any future policies for skin substitute products should focus on
serving the best interests of patients, protecting patient and provider
choice, and delivering value for payors. It is vital that responsible and
innovative companies like Convatec can continue to invest in pioneering skin
substitute products in the US. Convatec is committed to continuing to work
collaboratively with the US Administration and CMS on the development of
future policies.

 

Financial guidance

We previously guided to InnovaMatrix(®) revenue of approximately $50m in
FY25. As a result of the postponement of the LCD, and reflecting the ongoing
uncertainty in the market, we now expect InnovaMatrix(®) sales of
approximately $75m in FY25. There is no change to any other financial
guidance. Our four-month trading update is 22 May 2025.

 

 

Contacts

 Analysts/ Investors  David Phillips,                      +44 (0) 7909 324994

                      Vice President, Investor Relations   ir@convatec.com (mailto:ir@convatec.com)
 Media                FGS Global                           Convatec-UK@fgsglobal.com (mailto:Convatec-UK@fgsglobal.com)

About Convatec

Pioneering trusted medical solutions to improve the lives we touch: Convatec
is a global medical products and technologies company, focused on solutions
for the management of chronic conditions, with leading positions in Advanced
Wound Care, Ostomy Care, Continence Care, and Infusion Care. With more than
10,000 colleagues, we provide our products and services in around 90
countries, united by a promise to be forever caring. Our solutions provide a
range of benefits, from infection prevention and protection of at-risk skin to
improved patient outcomes and reduced care costs. Convatec's revenues in 2024
were over $2 billion. The company is a constituent of the FTSE 100 Index
(LSE:CTEC). To learn more please visit http://www.convatecgroup.com
(http://www.convatecgroup.com/)

 

Forward Looking Statements

This document includes certain forward-looking statements with respect to the
operations, performance and financial condition of the Group. Forward-looking
statements are generally identified using terms such as "believes",
"estimates", "aims", "anticipates", "expects", "intends", "plans", "predicts",
"may", "will", "could", "targets", continues", or their negatives or other
similar expressions. These forward-looking statements include all matters that
are not historical facts.

Forward-looking statements are necessarily based upon a number of estimates
and assumptions that, while considered reasonable by the Company, are
inherently subject to significant business, economic and competitive
uncertainties and contingencies that are difficult to predict and many of
which are outside the Group's control. As such, no assurance can be given that
such future results, including guidance provided by the Group, will be
achieved. Forward-looking statements are not guarantees of future performance
and such uncertainties and contingencies, including the factors set out in the
"Principal Risks" section of the Strategic Report in our Annual Report and
Accounts, could cause the actual results of operations, financial condition
and liquidity, and the development of the industry in which the Group
operates, to differ materially from the position expressed or implied in the
forward-looking statements set out in this document. Past performance of the
Group cannot be relied on as a guide to future performance.

Forward-looking statements are based only on knowledge and information
available to the Group at the date of preparation of this document and speak
only as at the date of this document. The Group and its directors, officers,
employees, agents, affiliates and advisers expressly disclaim any obligations
to update any forward-looking statements (except to the extent required by
applicable law or regulation).

LEI number - 213800LS272L4FIDOH92

 

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