Affluent Medical: First half 2021 financial results and main clinical update.


Affluent Medical Affluent Medical: First half 2021 financial results and main clinical update. 22-Sep-2021 / 17:45 CET / CEST Broadcast of French regulatory news, transmitted by EQS Group. The issuer is solely responsible for the content of this advertisement.

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PRESS RELEASE

Aix-en-Provence, September 22, 2021 – 5:45 pm

Financial results for the first half of 2021

and main clinical update

Affluent Medical (ISIN code: FR0013333077 – mnemonic: AFME), French medtech specializing in the international development and industrialization of innovative medical prostheses – at the clinical stage – to treat urinary incontinence and pathology of the cardiac mitral valve , publishes its financial results report today for the first half of 2021 and takes stock of the development of its various clinical studies.

OVERVIEW OF FINANCIAL INFORMATION

The main financial elements under IFRS are presented in the table below and were approved by the Board of Directors at its meeting of September 20, 2021. The audit work and the limited review of the half-year accounts were carried out by the Statutory Auditors.

The complete financial statements are available on our website: www.affluentmedical.com.

Consolidated income statement 
                                                                30/06/2021 30/06/2020 
(in thousands of euros) 
                                                                6 months   6 months 
Other operating income                                          596        357 
Purchases consumed                                              (1,351)    (1,509) 
External expenses                                               (3,111)    (1,687) 
Personnel expenses                                              (2,573)    (2,233) 
Taxes and duties                                                (31)       (26) 
Provisions net of reversals                                     153        (50) 
Other current operating income and expenses                     134        (49) 
Depreciation and amortisation                                   (1,176)    (742) 
 
CURRENT OPERATING INCOME                                        (7,359)    (5,939) 
 
OPERATING INCOME after share of net income of equity affiliates (7,373)    (6,214) 
 
Financial income (loss)                                         (339)      (1,278) 
Income taxes                                                    103        115 
 
Net income (loss) for the period                                (7,610)    (7,052) 
 
Cash flow from operating activities                             (5,203)    (5,542) 
Cash flow from investing activities                             (218)      (214) 
Cash flow from financing activities                             19,918     6,105 
 
Increase (Decrease) in cash                                     14,497     349 
 
Cash and cash equivalents                                       20,145     2,475

Operating expenses amounted to 7,955 thousand euros as of June 30, 2021 compared to 6,296 thousand euros as of June 30, 2020, an increase of 1,660 thousand euros. This variation is mainly explained by the costs related to the Company’s IPO in the first half of 2021, which amounted to 1,181 thousand euros in expenses, as well as by the strengthening of the research and development teams and regulatory affairs of the Group.

During the first half of 2021, purchases consumed decreased by 158 thousand euros compared to the first half of 2020. This decrease is mainly due to the decrease in external research expenses offset by the increase in laboratory supplies.

The increase of 538 thousand euros in personnel costs (excluding IFRS 2 – Share-based payments) is explained by the gradual strengthening of the Group’s research and development and regulatory affairs teams.

The financial result was improved by the early redemption of convertible bonds following the IPO.

The increase in cash consumption linked to financing activities is mainly linked to the capital increase carried out on June 14, 2021, during the Company’s initial public offering for a gross value of 25,000 thousand euros, including the conversion of the Kreos Capital debt.

MAIN HIGHLIGHTS SINCE JANUARY 1, 2021

– Successful IPO on Euronext Paris

On June 9, 2021, Affluent Medical announced the success of its initial public offering on the regulated market of Euronext Paris. In this context, the Company carried out a capital increase of 25 million euros, with the issue of 2,906,978 new ordinary shares.

– New clinical advances for the three new generation minimally invasive medical devices in urology and functional heart

New patients were enrolled in the pivotal Kalios Mitral Valve Ring study, the only ring that can be readjusted multiple times after being implanted without surgery. In order to include all the patients in the study, and despite the health crisis in Europe, new centers will be added to the nine current clinical centers.

An adjustment of the Kalios mitral ring was performed on July 12, 2021 by Prof. A. Albertini at Cotignola hospital in Italy 11 months after its implantation. The mitral regurgitation was a grade 4+ leak. Mitral regurgitation occurs in 40% of cases after implantation of the ring. Postoperative results are as expected and reduced mitral leakage to grade 1+ leakage. The surgeon noted that the adjustment via the transcatheter route was easy and quick.

The patient, who is under scheduled medical supervision, is currently classified as NYHA I[1] and therefore has no limitation in its daily activities.

The Czech and Spanish ethics committees have issued a favorable opinion on the launch of a pivotal study on the Artus medical device for the treatment of moderate to severe urinary incontinence. Regulatory authorization requests have also been filed with the health authorities of the two countries. The Company is currently responding to the relevant Spanish and Czech authorities as part of the regulatory clearance request process for our pivotal study. In Spain, following delays due to the Covid-19 crisis, this review was extended for three months at the request of the Spanish health authorities.

The recruitment of patients as part of the pilot study to carry out the implementation of the

An Epygon valve bioprosthesis, capable of mimicking the native mitral valve and restoring physiological blood flow in the heart, is underway in Austria, Italy and Spain. As part of our agreement with a distributor in Spain, new investigation centers are currently being opened. All surgeons from the four clinical centers participating in this clinical study have received training on the Epygon device and the feedback is currently very positive.

– Appointment of two internationally renowned professors to the Scientific Council and strengthening of the organization

Appointment of Véronique Phé and Roxana Mehran to the Scientific Committee of Affluent Medical

Prof. Véronique Phé is a doctor of medicine specializing in urological surgery. She is the first woman to have been appointed professor of the universities of urology and teaches at La Sorbonne. His clinical practice focuses on functional urology and neuro-urology, and in particular on urinary incontinence in women and men. She has developed skills in reconstructive surgery and minimally invasive surgery with robot-assisted laparoscopic procedures applied to neurourological and incontinent patients. She holds various positions within learned societies in urology (French Association of Urology, French College of Urologists, etc.). In addition, she has published over 140 articles in renowned scientific journals (European Urology, Nature Reviews Urology, BJU International, Journal of Urology, etc.) and has received various national and international awards for her work in urology, including the prestigious “EAU Crystal Matula Prize” in 2021.

Professor Roxana Mehran, MD, FACC, FACP, FCCP, FESC, FAHA, FSCAI is an internationally renowned interventional cardiologist specializing in clinical research and health policy at the Icahn School of Medicine, Mount Sinai Hospital, New York, United States. Prof. Mehran has established a world-renowned academic research center and has carried out numerous studies all over the world as a principal investigator.

She is currently a member of the Board of Trustees of the American College of Cardiology (ACC) and is a Founder and Scientific Director of the Cardiovascular Research Foundation (CRF). She has been named for three consecutive years in Clarivate Analytics as “Most Cited Researchers – Top 1%” and “The World’s Most Influential Scientists” (Thomson Reuters).

Professor Mehran currently heads the Lancet Commission on Cardiovascular Disease in Women, which brings together leading researchers from around the world with clinical expertise in cardiovascular medicine.

Professor Mehran has received several awards, including the Bernadine Healy Leadership in Cardiovascular Disease Award 2016 from the American College of Cardiology, the Women’s Heart Nanette Wenger Award for Excellence in Research and Education, the Ellis Island Medal of Honor 2019, the ESC Silver Medal 2019. and the Andreas Grüntzig Lecture plaque.

Appointment of Jean-Dominique Béhéty as director of the Kalios program

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September 22, 2021 11:45 am ET (3:45 pm GMT)


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