September 14, 2017
TOULOUSE, France–(BUSINESS WIRE)–Regulatory News:
VEXIM (FR0011072602 – ALVXM / PEA‐PME) (Paris:ALVXM), a medical device company specializing in the minimally-invasive treatment of vertebral fractures, announces its consolidated results for the first half of 20172 in line with guidance3.
“Our sales performance and controlled expenses for the first half of 2017 are in line with our expectations. This trend should be reinforced in the second half of 2017 allowing us to remain confident in reaching profitability for 2017. On the U.S. development, we are excited to announce we will hold an investors meeting at the upcoming 2017 NASS Congress in Orlando where we will share information on our on-going FDA clinical trial comparing SpineJack® to balloon kyphoplasty and also the go-to-market strategy that will support the launch of SpineJack® in the U.S., subject to 510(k) clearance. These various milestones further position our company to become a global leader in the spine-trauma market,” said Vincent Gardès, VEXIM’s CEO.
+21% increase in sales, gross margin of 72.6% and significant net loss reduction
VEXIM’s sales reached €10.4 million in the first half of 2017, up 21% compared to the same period of 2016. This significant revenue growth shows the effectiveness of the direct sales strategy implemented for SpineJack® in Europe, combined with a network of specialized distributors at the international level (see press release on VEXIM’s sales in the first half of 20174).
The gross profit increased 19% compared to the first half of 2016, up to €7.5 million, representing a 72.6% gross margin (as percentage of sales) vs. 73.8% on the same period last year and 72.2% for the full year 2016. Given the implementation of the direct sales strategy, VEXIM maintained a high level of gross margin, in a context of stable prices.
Compared to the 21% increase in revenue, operating expenses decreased 1%, to €9.0 million, compared with the first half of 2016. The effective control of operating expenses resulted in a saving of €1.3 million in the net operating loss, down to €1.5 million. Net loss for the period was €1.6 million.
| Consolidated statement as of June 30, 2017 | |||||||
| in € millions | First Half 2017 | First Half 2016 | YoY (%) | ||||
| Sales | 10.4 | 8.6 | 21% | ||||
| Gross profit (gross margin) | 7.5 (72.6%) | 6.3 (73.8%) | 19% | ||||
| Operating expenses | 9.0 | 9.1 | -1% | ||||
| Net operating income (loss) | -1.5 | -2.8 | -46% | ||||
| Net income (loss) | -1.6 | -2.8 | -43% | ||||
Solid cash position at €5.7 million
As of June 30, 2017, VEXIM had €5.7 million in cash, allowing the company to secure its future development. The company’s current cash position and future cash flows should allow VEXIM to continue to grow in-line with its ambitions.
Other business achievements over the first half of 2017
- Finalized recruitment of all patients for the FDA study supporting the 510(k) filing for SpineJack® in the U.S.;
- Launch of a dedicated and specific product for the German market: Masterflow™ Plus;
- Regulatory approval of SpineJack® in Brazil.
Full-year 2017 guidance confirmed
Given the Company’s solid results for the first half of 2017, VEXIM is on track to reach its full-year 2017 objectives:
- Maintain strong revenue growth and reach 30% growth over the full year 2017;
- Achieve profitability for the full year 2017 and generate operational positive cash-flows;
- Further expand internationally through upcoming distribution agreements in Brazil by the end of 2017;
- Share information on the on-going 510(k) clinical trial and subsequent go-to-market strategy in the U.S. at the upcoming NASS meeting in Orlando;
- Continue innovating in the treatment of high energy vertebral fractures through product development projects, leveraging the SpineJack® platform;
- Continue to develop and penetrate the German market;
- Regarding the transfer of VEXIM shares to the regulated market of Euronext Paris, which was authorized by the Board of Directors on 21 March 2017, the company is still reviewing all necessary requirements and changes needed to pursue this project. VEXIM aims at completing this review shortly and will complete the transfer by the end of 2017 or beginning of 2018.
Financial reporting schedule:
3rd quarter sales results: Wednesday, October 25th, 20175 (after market close)
|
NASS 2017: Vexim Investor & Analyst Lunch Meeting & Webcast U.S. FDA clinical trial update and go-to-market strategy (in English)
Wednesday, October 25th, 2017 at 12:00 PM ET (Orlando) / 6:00 PM CEST (Paris time)
To join please contact: For U.S.: The Ruth Group at epoalillo@theruthgroup.com or Tel : +1 646 536 7024 For EU & Intl: Alize RP at vexim@alizerp.com or Tel. : +33 1 44 54 36 66
A replay of the webcast will be available on VEXIM’s website within 48 hours at: http://www.vexim.com/us/ (U.S. section of the website) > shareholder area |
About VEXIM, the innovative back microsurgery specialist
Based in Balma, near Toulouse (France), VEXIM is a medical device company created in February 2006. The company has specialized in the creation and marketing of minimally-invasive solutions for treating traumatic spinal pathologies. Benefitting from the financial support of it long-standing shareholder, Truffle Capital6 and from BPI public subsidies, VEXIM has designed and developed the SpineJack®, a unique implant capable of repairing a fractured vertebra and restoring the balance of the spinal column. The company also developed the MasterflowTM, an innovative solution for mixing and injecting orthopedic cement that enhances the accuracy of the injection and optimizes the overall surgical procedure. The company counts 67 employees, including its own sales teams in Europe and a network of international distributors.
VEXIM has been listed on Euronext Growth since May 2012. For further information, please visit www.vexim.com
SpineJack® 7, a revolutionary implant for treating vertebral fractures
The revolutionary aspect of the SpineJack® lies in its ability to restore a fractured vertebra to its original shape, restore the spinal column’s optimal anatomy and thus remove pain and enable the patient to recover their functional capabilities. Thanks to a specialized range of instruments, inserting the implants into the vertebra is carried out by minimally-invasive surgery, guided by X-ray, in approximately 30 minutes, enabling the patient to be discharged shortly after surgery. The SpineJack® range consists of 3 titanium implants with 3 different diameters, thus covering 95% of vertebral fractures and all patient morphologies. SpineJack® technology benefits from the support of international scientific experts in the field of spinal surgery and worldwide patent protection through to 2029.
Name: VEXIM
ISIN code: FR0011072602
Ticker: ALVXM
Appendixes
|
Condensed consolidated interim financial statements |
|||||||||||
| In thousands of Euros | Six-month period ended | ||||||||||
| June 30, 2016 | June 30, 2017 | ||||||||||
| Revenue | 8 564 | 10 365 | |||||||||
| Cost of sales | (2 246) | (2 843) | |||||||||
| Gross profit | 6 318 | 7 522 | |||||||||
| Selling and marketing expenses | (4 927) | (5 001) | |||||||||
| Operational expenses | (1 619) | (1 572) | |||||||||
| General and administrative expenses | (2 773) | (2 714) | |||||||||
| Other gains / (losses), net | 240 | 284 | |||||||||
| Operating loss | (2 761) | (1 481) | |||||||||
| Finance income / (loss), net | (9) | (53) | |||||||||
| Loss before income tax | (2 770) | (1 534) | |||||||||
| Income tax expense | (36) | (54) | |||||||||
| Loss for the year | (2 806) | (1 588) | |||||||||
| Attributable to: | |||||||||||
| Equity holders of the Company | (2 806) | (1 588) | |||||||||
| – | – | ||||||||||
| Earnings per share attributable to the equity holders of the Company during the period | |||||||||||
| Basic earnings per share | (0,37) | (0,21) | |||||||||
| Diluted earnings per share | (0,37) | (0,21) | |||||||||
|
Interim consolidated balance sheet – Assets |
||||||||||
| In thousands of Euros |
December 31, |
June 30, 2017 | ||||||||
| Intangible assets | 2 229 | 3 226 | ||||||||
| Property and equipment | 1 382 | 1 649 | ||||||||
| Other receivables | 171 | 226 | ||||||||
| Deferred tax assets | 522 | 500 | ||||||||
| Non-current assets | 4 304 | 5 601 | ||||||||
| Inventories | 3 675 | 4 684 | ||||||||
| Trade receivables | 4 670 | 5 508 | ||||||||
| Other receivables | 2 255 | 2 112 | ||||||||
| Cash and cash equivalents | 9 765 | 5 734 | ||||||||
| Current assets | 20 365 | 18 038 | ||||||||
| Total assets | 24 669 | 23 639 | ||||||||
|
Interim consolidated balance sheet – Equity and liabilities |
||||||||||
| In thousands of Euros |
December 31, |
June 30, 2017 | ||||||||
| Ordinary shares | 762 | 764 | ||||||||
| Share premium | 61 109 | 61 296 | ||||||||
| Other reserves | 1 204 | 1 724 | ||||||||
| Retained earnings | (45 383) | (46 970) | ||||||||
| Equity attributable to equity holders of the Company | 17 693 | 16 813 | ||||||||
| Non-controlling interests | – | – | ||||||||
| Total equity | 17 693 | 16 813 | ||||||||
| Repayable advances | 427 | 43 | ||||||||
| Retirement benefit obligations | 111 | 125 | ||||||||
| Non-current liabilities | 538 | 168 | ||||||||
| Repayable advances | 314 | 400 | ||||||||
| Trade payables | 2 365 | 3 603 | ||||||||
| Other payables | 3 541 | 2 437 | ||||||||
| Provisions for other liabilities and charges | 218 | 218 | ||||||||
| Current liabilities | 6 438 | 6 658 | ||||||||
| Total liabilities | 6 976 | 6 826 | ||||||||
| Total equity and liabilities | 24 669 | 23 639 | ||||||||
|
Interim consolidated statement of cash-flow |
|||||||||||
| In thousands of Euros | Six-month period ended | ||||||||||
| June 30, 2016 | June 30, 2017 | ||||||||||
| Loss for the period | (2 806) | (1 588) | |||||||||
| Adjustments for: | |||||||||||
| Depreciation of tangible assets, amortization of intangible assets | 136 | 162 | |||||||||
| Impairment of receivables | 83 | (22) | |||||||||
| Impairment of inventories | 20 | 7 | |||||||||
| Share-based payments | 277 | 496 | |||||||||
| Change in retirement benefit obligation | 27 | 14 | |||||||||
| Variation in provisions for risks | 167 | – | |||||||||
| Income tax | 35 | 54 | |||||||||
| Cash used in operations before changes in working capital | (2 061) | (877) | |||||||||
| Changes in working capital | |||||||||||
| Inventories | (12) | (1 016) | |||||||||
| Trade receivables | (693) | (816) | |||||||||
| Other receivables | (436) | 178 | |||||||||
| Trade payables | (518) | 1 238 | |||||||||
| Other payables | 158 | (1 284) | |||||||||
| Cash used in changes in working capital | (1 501) | (1 700) | |||||||||
| Net cash used in operating activities | (3 562) | (2 577) | |||||||||
| Cash flows from investing activities | |||||||||||
| Purchases of property and equipment | (595) | (356) | |||||||||
| Purchases of intangible assets | (443) | (1 070) | |||||||||
| Disposal of assets | – | – | |||||||||
| Net cash used in investing activities | (1 038) | (1 426) | |||||||||
| Cash flows from financing activities | |||||||||||
| Proceeds from issuance of ordinary shares, net of issuance costs | 10 453 | 189 | |||||||||
| Direct costs paid related to capital increase | (421) | – | |||||||||
| Repayable advance | (210) | (314) | |||||||||
| Treasury shares | – | 69 | |||||||||
| Net cash generated by / (used) in financing activities | 9 822 | (56) | |||||||||
| Net increase / (decrease) in cash and cash equivalents | 5 222 | (4 059) | |||||||||
| Cash and cash equivalents at beginning of the period | 4 208 | 9 765 | |||||||||
| Effect of exchange rate fluctuations | (12) | 29 | |||||||||
| Cash, cash equivalents at end of the period | 9 418 | 5 734 | |||||||||
1 NASS : North American Spine Society : https://www.spine.org/
2 The results, which were subject to a limited review, have been approved by the Board of Directors of VEXIM at its meeting held on September 13th, 2017.
3 Consolidated financial statements presented in Appendix.
4 Press release published on July 11th, 2017: http://us.vexim.com/press/continued-growth-adoption-spinejack-q2-2017/
5 indicative date, subject to change.
6 Founded in 2001 in Paris, Truffle Capital is a leading independent European private equity firm. It is dedicated to investing in and building technology leaders in the IT, life sciences and energy sectors. Truffle Capital manages €550m via FCPRs and FCPIs, the latter offering tax rebates (funds are blocked during 7 to 10 years). For further information, please visit www.truffle.fr and www.fcpi.fr.
7 This medical device is a regulated health product that, with regard to these regulations, bears the CE mark. Please refer to the Instructions for Use.
Contacts
VEXIM
Vincent Gardès, CEO
José Da Gloria, Chief Financial Officer
Tél. : +33 5 61 48 48 38
investisseur@vexim.com
or
PRESS
ALIZE RP
Caroline Carmagnol / Wendy Rigal
Tél. : +33 1 44 54 36 66
Tél. : +33 6 48 82 18 94
vexim@alizerp.com
