Stentys : Financial Information for the First Quarter of 2019

Financial Information for the First Quarter of 2019

• ▪ Q1 consolidated revenues of €2.6 million

• ▪ A return to sales growth for the Xposition S stent: +4% by volume and +0.1% by value

• ▪ Successful commercial launch in South Africa

• ▪ Consolidated cash position of €8.6 million at March 31, 2019

• ▪ New scientific publication confirming the clinical benefits of the Xposition S stent in complex anatomies

PARIS - April 11, 2019 - 5.45 pm CEST - STENTYS (FR0010949404 - STNT), a French group specialized in medical technologies for interventional cardiology, today reports its quarterly revenues and consolidated cash position at March 31, 2019.

Christophe Lottin, Chief Executive Officer of STENTYS, comments: "STENTYS has recorded a good start to 2019, with a return to sales growth for the Xposition S stent. The strategy aimed at refocusing our efforts on the best-performing and most profitable products in our portfolio combined with the various organizational changes undertaken in our direct sales network are beginning to yield positive results. Our objective is to deploy our new product range on markets with the highest growth momentum. In this respect, we are therefore delighted with our successful commercial launch in South Africa. With a solid cash position and a streamlined product range, we are continuing our development in the most attractive geographical regions. Furthermore, another scientific publication has again confirmed the clinical benefit of the Xposition S stent in various types of complex coronary lesions, making it one of the most reliable treatments in this indication."

First-quarter revenues by geographical region

€ thousands

Q1 2019

Q1 2018

% change

Q1 2019

Q1 2018 Pro forma1

% change

Europe2

Rest of the world

1,357 1,243

Total revenues

2,600

869 470 1,339

+56%

n.a.

1,357 1,243

1,485 -9%

1,338 -7%

+94%

2,600

2,823

-8%

Audited data

First-quarter revenues by product category

€ thousands

Q1 2019

Q1 2018

% change

Q1 2019

Q1 2018 Pro forma1

% change

Stents

Balloons & accessories

1,638 961

1,320 19

+24%

n.a.

1,638 961

1,830 -10%

993 -3%

Total revenues

2,600

1,339

+94%

2,600

2,823

-8%

Audited data

1 Pro forma data not yet reviewed by the statutory auditors, presented in accordance with IFRS 15 (mandatory application) with no difference compared with IAS 18 applied in 2017. The acquisition of Minvasys by STENTYS was completed on April 30, 2018 and its activity consolidated from May 1, 2018. This data was calculated to provide a comparable vision of the Group's activity as if the acquisition had been completed on January 1, 2018.

2 Germany, Italy, Switzerland, Austria, Poland, Netherlands, France, Belgium, United Kingdom, Spain, Greece, Portugal and Nordic countries.

Including the activity generated by MINVASYS, consolidated from May 1, 2018, the STENTYS group recorded revenues of €2.6 million in the first quarter of 2019, up +94% compared with the same quarter of 2018, but down 8% pro forma.

The first quarter of 2019 was marked by a return to sales growth for the Xposition S stent (+0.1% by value and +4% by volume). This fine performance was a result of positive momentum in Europe, and in particular in Southern and Eastern Europe, as well as Nordic countries, following the various organizational changes implemented in 2018.

STENTYS is continuing to expand its geographical coverage with the opening of South Africa, where the Group undertook the promising commercial launch of its entire product range during the first quarter of 2019.

In order to rationalize its product range, STENTYS has decided to focus its efforts on the most recent and most strategic generations of products. Hence, restated for previous generations of balloons, stents and valve connectors, the Group's sales recorded quarterly growth of 5%, including 8% for the MINVASYS range, pro forma.

Solid cash position of €8.6 million

The Group had a cash position of €8.6 million at March 31, 2019 versus €9.9 million at December 31, 2018, again reflecting strict cost management.

New publication confirming the clinical benefits of the Xposition S stent in complex anatomies

On March 23, 2019, the results of a study entitled "Dutch multicenter experience using the STENTYS Xposition S self‐apposing stent in complex coronary lesions"3 were published in the 'Catheterization and Cardiovascular Interventions' professional journal.

The study, undertaken on 215 patients in 4 Dutch hospitals over a 3-year period from March 2015 to March 2018, is a subgroup of the ongoing SIZING registry. SIZING is a prospective, single-arm multi-centre trial whose goal is to provide data on the safety of STENTYS stents with clinical results in routine use.

The results at 12 months have confirmed the safety and efficacy of the Xposition S self-apposing stent in the treatment of challenging lesions in actual clinical practice, with a high procedural success rate and a low major adverse cardiac events (MACE) rate at 12 months of 6.6%.

A wide variety of patients, including 76.9% suffering from an acute coronary syndrome, were included in the study. The main angiographic indications were lesions in aneurysmatic or ectatic vessels (32.3%), thrombus containing lesions (13.1%) and bifurcation / left main stenosis (10.4%), with over half of the lesions classified as AHA/ACC Type C lesions.

The authors of the study concluded: "In the clinical practice of our sites in the Netherlands, self-apposing STENTYS Xposition S shows good procedural results despite complex coronary anatomy. The observed clinical events rate remains low at 1 year."

Professor Christian Spaulding, Georges-Pompidou European Hospital, Paris, France, President of STENTYS' scientific committee, added: "The positive results of this study further confirm the benefits of using a self-apposing stent in challenging lesions and anatomies. Interestingly, this study's patient population consists of a group of patients often excluded from conventional drug eluting stent registries, and highlights the role that Xposition S can play in treating these often challenging patients."

Additional data will be published at EuroPCR, the leading annual forum on interventional cardiology, which will be held from May 21 to 24, 2019 in Paris.

3 Dutch multicenter experience using the STENTYS Xposition S self‐apposing stent in complex coronary lesions; Selina Vlieger MSc, Cihan Simsek MD, PhD, Anaïs Balland MSc, Sami Somi MD, Gillian Jessurun MD, Giovanni Amoroso MD, PhD, Floris Kauer MD, PhD, Robert-Jan van Geuns MD, PhD and Alexander IJsselmuiden MD, PhD;https://doi.org/10.1002/ccd.28192

Upcoming financial publications and events

• • General Shareholders' Meeting: Thursday May 16, 2019 at 4 pm, 21 place de la Madeleine, 75008 Paris (or, if necessary, on the second call on Tuesday June 25, 2019)

• • Revenues for the second quarter of 2019: Thursday July 11, 2019 (after market)

About STENTYS

The STENTYS group develops and markets minimally-invasive cardiovascular solutions for the needs of interventional cardiology. Its extensive range of innovative products, including drug-eluting stents, coronary and drug-eluting balloons as well as cardiovascular accessories, is marketed in over 60 countries. Thanks to its flagship product, Xposition S, the self-apposing stent that adapts to vessels with variable diameters and enables the treatment of complex arterial disorders, and to its portfolio of balloons and accessories, STENTYS covers all coronary indications.

Additional information is available atwww.stentys.com

This press release contains forward-looking statements about the Company that are based on numerous assumptions regarding the Company's present and future business strategies and the environment in which it will operate in the future which may not be accurate. Such forward-looking statements involve known and unknown risks which may cause the Company's actual results, performance or achievements to differ materially from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors include, among others, risks associated with the development and commercialization of the Company's products, market acceptance of the Company's products, its ability to manage growth, the competitive environment in relation to its business area and markets, its ability to enforce and protect its patents and proprietary rights, uncertainties related to the U.S. FDA approval process, slower than expected rates of patient recruitment for clinical trials, the outcome of clinical trials, and other factors, including those described in the Section 4 "Risk Factors" of the Company's 2016 Registration Document (document de référence) filed with the French Autorité des Marchés Financiers (AMF) on November 29, 2017 under number D.17-1084.