• Consolidated revenues for the third quarter of 2019: €1.3 million, down 41%
  • Sales of the Amazonia SIR stent temporarily suspended
  • Consolidated cash position at September 30, 2019: €8.0 million

Regulatory News:

STENTYS (Paris:STNT) (FR0010949404 — STNT), a French group specialized in medical technologies for interventional cardiology, today announced its quarterly revenues and consolidated cash position at September 30, 2019.

Revenues for the third quarter and first 9 months of 2019

€ thousands

Q3 2019

Q3 2018

% change

9M 2019

9M 20181

% change

Europe2

930

1,164

-20%

3,771

3,318

+14%

Rest of the world

403

1,105

-63%

2,625

2,590

+1%

Total revenues

1,333

2,269

-41%

6,396

5,908

+8%

Audited data (except pro forma information)

€ thousands

Q3 2019

Q3 2018

% change

9M 2019

9M 20181

% change

Stents

501

1,416

-65%

3,512

4,366

-20%

Balloons & accessories

832

853

-2%

2,884

1,543

+87%

Total revenues

1,333

2,269

-41%

6,396

5,908

+8%

Audited data

STENTYS completed the acquisition of MINVASYS during the second quarter of 2018, its activity being consolidated from May 1, 2018. The changes presented for the first 9 months of 2019 are therefore partly due to different scopes of consolidation. The following pro forma information thus provides a vision of revenue changes on a comparable basis.

Pro forma revenues for the first 9 months of 2019

€ thousands

9M 2019

9M 2018

Pro forma3

% change

Europe2

3,771

4,115

-8%

Rest of the world

2,625

3,662

-28%

Total revenues

6,396

7,777

-18%

Audited data (except pro forma information)

€ thousands

9M 2019

9M 2018

Pro forma3

% change

Stents

3,512

4,972

-29%

Balloons & accessories

2,884

2,806

+3%

Total revenues

6,396

7,777

-18%

Audited data (except pro forma information)

Over the first 9 months of 2019, the Group generated revenues of €6.4 million, down 18% compared with the first 9 months of 2018 (pro forma1), heavily impacted by a 41% fall in the third quarter of 2019 compared with the third quarter of 2018.

Within the framework of a CE marking renewal process, the Company received a request from the French health authorities on August 2, 2019, following the announcement of its planned early dissolution, to suspend sales of its Amazonia SIR stent within the framework of a transitional regulatory provision. On October 7, 2019, the Company was authorized to resume sales of this product until January 8, 2020. Amazonia SIR stent sales thus tumbled 89% in the 3rd quarter of 2019.

Within this context, the Company’s procurement difficulties significantly intensified in the third quarter of 2019, leading to a 55% decrease in sales of the Xposition S stent. In contrast, Minvasys’ coronary balloon ranges recorded growth of 14% in the third quarter of 2019.

Cash position of €8.0 million

The Group had a cash position of €8.0 million on September 30, 2019 compared with €8.1 million on June 30, 2019. This variation is mainly due to the context in which the Company is operating, and in particular to the receipt of cash orders and limited production in the third quarter of 2019.

Upcoming publications

  • The Company will publish its half-yearly financial statements at net asset value on Monday October 14, 2019.
  • The next steps relative to the Company’s planned dissolution will be indicated in the press release of Monday October 14, 2019 presenting half-yearly financial statements at net asset value.

Extraordinary Shareholders’ Meeting of October 21, 2019

STENTYS will hold its Extraordinary Shareholders’ Meeting on October 21, 2019 at 4 pm CEST at the Bedford Hotel, 17 rue de l'Arcade, 75008 Paris.

Preparatory documents for this Meeting, including the postal voting form, are available on the Company’s website, www.stentys.com, in the Investisseurs / Assemblée générale section of the French version.

If you are a STENTYS shareholder and wish to vote on the resolutions, you can:

  • vote via your bank’s web portal, if your bank subscribes to the VOTACCESS platform,
  • vote by post, in accordance with the T&Cs indicated in the Participation Guide available on the STENTYS website,
  • attend in person, by requesting an admission ticket.

Should the required quorum not be met, the Extraordinary Shareholders’ Meeting on the second call would be held on November 14, 2019 and postal votes will remain valid and taken into account.

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 at www.stentys.com.

STENTYS is listed on Compartment C of Euronext Paris

ISIN: FR0010949404 – Ticker: STNT

 

Forward-looking statements

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.

1 Pro forma data not yet reviewed by the statutory auditors, presented in accordance with IFRS 15. 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.

3 Pro forma data not yet reviewed by the statutory auditors, presented in accordance with IFRS 15. 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.

STENTYS André Lerebours CFO Tel.: +33 (0)1 44 53 99 42 investor@stentys.com

NewCap Investor Relations / Strategic Communications Dusan Oresansky / Alexia Faure Tel.: +33 (0)1 44 71 94 92 stentys@newcap.eu