REG - Renalytix PLC - AGM Statement

RenalytixAnnouncement

19/12/2024 07:00

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RNS Number : 6674Q  Renalytix PLC  19 December 2024

Renalytix plc

("Renalytix" or the "Company")

 

AGM Statement

 

LONDON and NEW YORK, 19 December 2024 - Renalytix plc (LSE: RENX) (OTCQB:
RNLXY), which is commercialising the only FDA-approved and Medicare reimbursed
prognostic test to support early-stage risk assessment for chronic kidney
disease, provides an update to shareholders ahead of its Annual General
Meeting ("AGM") today at 6 Stratton Street Mayfair, London W1J 8LD at 11.00
(GMT).

 

AGM Statement from Julian Baines, Executive Chairman

 

I am pleased to provide an update to shareholders following our successful
£11.8m funding round last month, and the refocusing of the business to
deliver scalable commercial revenues with a significantly reduced cost base.

 

We have commercialized, kidneyintelX.dkd, the first insured, FDA approved
advanced prognostic test for progressive kidney disease, one of the leading
causes of chronic disease cost and suffering globally. In June, we crossed the
major milestone of achieving full Medicare reimbursement at $950 per test,
which provides insurance payment for over half of our US addressable patient
market. KidneyintelX.dkd is recommended in the international clinical care
guidelines, and is now commercially available to around 14 million US diabetic
kidney disease patients.

 

Our new commercial strategy is working and we are delivering growth from our
Direct-to-Doctor sales force and our hospital systems partners through
electronic health record integration. Electronic health record Integration is
a powerful model which automatically alerts doctors to patients who are
eligible for kidneyintelX.dkd. We have clear evidence that this approach
provides significant leverage to our on-ground sales force and supports busy
doctors for repeated testing of new patients in need.  The benefits of this
integrated approach were proved again with the onboarding of a large New
York-based primary care network on board in September.

 

As expected, our sales representative productivity continues to improve with
the current ratio of average tests ordered per month per sales representative
at record levels. The need to urgently address the burden of chronic disease
within the US health care system continues to resonate with front-line doctors
making critical choices for diabetes and kidney disease patients and our
conversations with additional large group practices are encouraging, and we
expect to update shareholders regarding further new adopters in 2025.

 

We remain on target to significantly reduce cash burn by June 2025, and we
remain confident that continued growth will deliver our estimated $3.2m
revenue target for the year ended June 2025. We also remain steadfast in
aligning management and shareholder interests through performance related
long-term incentive plans and management market share purchases during open
periods. Our goal remains that of delivering significant value to our fellow
shareholders. Thank you for your support and confidence.

 

 

For further information, please contact:

 

 Renalytix plc                                www.renalytix.com (http://www.renalytix.com)
 James McCullough, CEO                        Via Walbrook PR

 Stifel (Nominated Adviser and Joint Broker)  Tel: 020 7710 7600
 Nicholas Moore / Nick Harland / Ben Good

 Oberon Capital (Joint Broker)                Tel: 020 3179 5300
 Mike Seabrook / Nick Lovering

 Walbrook PR Limited                          Tel: 020 7933 8780 or renalytix@walbrookpr.com
 Paul McManus / Alice Woodings                Mob: 07980 541 893 / 07407 804 654

 CapComm Partners
 Peter DeNardo                                Tel: 415-389-6400 or investors@renalytix.com

 

About Renalytix (www.renalytix.com (http://www.renalytix.com) )

Renalytix (LSE: RENX) (OTCQB: RNLXY) is an artificial intelligence-enabled in
vitro diagnostics company, focused on optimizing clinical management of kidney
disease to drive improved patient outcomes. Renalytix has received FDA
approval and Medicare reimbursement for kidneyintelX.dkd which is now offered
commercially in the United States.

 

Unrecognized and uncontrolled kidney disease remains one of the largest
barriers to controlling cost and suffering in the United States and the United
Kingdom's medical system, affecting over 14 million and 8 million people,
respectively. After five years of development and clinical validation,
kidneyintelX.dkd is the only FDA-approved and Medicare reimbursed prognostic
tool capable of understanding a patient's risk with kidney disease early where
treatment has maximal effect. kidneyintelX.dkd is now being deployed across
large physician group practices and health systems in select regions of the
United States.

 

The over 10,000 patients that have been tested by kidneyintelX.dkd have
produced a substantial body of real-world performance data. In patient
populations where kidneyintelX.dkd has been deployed, a demonstrated and
significant increase in diagnosis, prognosis, and treatment rates have been
recorded. kidneyintelX.dkd now has full reimbursement established by Medicare,
the largest insurance payer in the United States, at $950 per reportable
result. kidneyintelX.dkd is also recommended for use in the international
chronic kidney disease clinical guidelines (KDIGO).

 

 

 

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