Regulatory News:

SpineGuard (Paris:ALSGD) (FR0011464452 – ALSGD), an innovative company that designs, develops, and markets disposable medical devices intended to make spine surgery safer, announced today financial results for the half year ending June 30, 2017, as approved by the Board of Directors on September 13, 2017.

Stéphane Bette, CEO of SpineGuard, said: “We are particularly gratified by the first half result for 2017 because it combines sales growth and significant improvement in our operational result. These results show our ability to capitalize on our solid foundations and optimize our operational functions with the view of reaching profitability towards the end of 2018. This six months was also very fruitful in terms of strategic alliances, with the signing of two major deals: the distribution in China with XR Medical, which opens great long term perspectives in the second largest spinal market worldwide; and, the exclusive licensing with Adin Dental Implants that illustrates the value of our technology beyond spine surgery.”

         
€ thousands – IFRS   H1 2017   H1 2016
Revenue   4,199   3,633
Gross margin   3,613   3,105
Gross margin (% of revenue)   86,0%   85,5%
Sales, distribution, marketing -3,400 -3,477
Administrative costs -1,055 -1,076
Research & Development -684 -764
Operating profit / (loss)   -1 ,526   -2 ,212
Non recurring operating costs   -152   0
Financial result   -566   -260
Income tax   0   0
Net profit / (loss)   -2,244   -2,472

NB : unaudited

Sales growth and reduced operating loss

For H1 2017, the Company reported revenue of €4,199k, up 16% (13% cc) compared with H1 2016.

Revenue in the United States increased 19% (15% cc) to €3,397k in the first half of 2017, compared with €2,866k in the first half of 2016. In the rest of the world, revenue increased 5% during the first half of 2017 to €802k compared with €767k in the first half of 2016.

4,264 DSG units were sold in the first half of 2017 compared with 4,351 in the first half of 2016, including 2,589 in the United States, representing 61% of total units sold.

Gross margin of 86.0% at June 30, 2017 compares favorably with the prior year result of 85.5%. The change mainly reflects a stronger ASP in the USA in particular thanks to the PediGuard Threaded.

Operating expenses were €5,139k compared with €5,318k for H1 2017, a decrease of 4% compared with June 30, 2016.

Working capital requirements were €840k compared with €955k at December 31, 2016. This continues to illustrate the relatively low operating cash needs of the Company and the efficient management of its financial resources.

At June 30, 2017, cash and cash equivalents were €2,061k compared with €1,804k at December 31, 2016, and is explained as follows:

  • The operating cash flow of €(1,494)k compared with the same period last year of €(2,732)k.
  • The payment of interests to IPF Partners of €178k and to Bpifrance of €37k.
  • The equity funding for a net amount of €1,855k in April 2017.

The Company’s workforce count is 28 at H1 2017, flat compared to end of December 2016.

Recent events and outlook:

  • The appointment of Stéphane Bette, co-Founder, CTO and US General Manager, as CEO of the company effective on July 13th; Pierre Jérôme, who has served as CEO since the company’s founding, continues to serve as Board Director of the company;
  • the signature of an exclusive distribution agreement with XinRong Medical Group for PediGuard® in China, the second largest spinal market worldwide;
  • the first licensing deal for DSG™ technology outside spine with Adin in dental implantology;
  • the US Patent Office granted a new patent for DSG™ technology in digital health: Bone Quality Measurement;
  • the 10th scientific publication on PediGuard clinical value;
  • the implementation of a profitability plan to reach operating breakeven by the end of 2018;
  • SpineGuard is actively pursuing other industry partnerships for expanded commercial applications of its proprietary digital DSG™ technology within the spinal and broader musculoskeletal sector to trigger new sources of revenue;
  • in the USA, SpineGuard’s primary commercial focus, the launch of the Zavation DSG™ screw is scheduled at the coming NASS (North American Spine Society) mid-October in Orlando (FL).

Next financial press release: Third quarter 2017 revenue on October 5, 2017

About SpineGuard®
Founded in 2009 in France and the USA, by Pierre Jérôme and Stéphane Bette, SpineGuard’s mission is to make spine surgery safer by bringing real-time digital technology into the operating room. Its primary objective is to establish its proprietary DSG™ (Dynamic Surgical Guidance) technology as the global standard of surgical care, starting with safer screw placement in spine surgery and then in other surgeries. PediGuard®, the first device designed using DSG, was co-invented by Maurice Bourlion, Ph.D., Ciaran Bolger, M.D., Ph.D., and Alain Vanquaethem, Biomedical Engineer. It is the world’s first and only handheld device capable of alerting surgeons to potential pedicular or vertebral breaches. Over 55,000 surgical procedures have been performed worldwide with DSG™ enabled devices. Numerous studies published in peer-reviewed medical and scientific journals have demonstrated the multiple benefits that PediGuard® delivers to patients, surgical staff and hospitals. SpineGuard is expanding the scope of its DSG™ platform through strategic partnerships with innovative medical device companies and the development of smart instruments and implants. SpineGuard has offices in San Francisco and Paris. For further information, visit www.spineguard.com.

Disclaimer
The SpineGuard securities may not be offered or sold in the United States as they have not been and will not be registered under the Securities Act or any United States state securities laws, and SpineGuard does not intend to make a public offer of its securities in the United States. This is an announcement and not a prospectus, and the information contained herein does and shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of the securities referred to herein in the United States in which such offer, solicitation or sale would be unlawful prior to registration or exemption from registration.