Theraclion Achieves Strong Sales and Accelerates Its Commercial Development in the First Half of 2017

  • 11 commercial agreements already signed1: + 120% V1H'16
  • € 0.6 million in sales: + 21% V1H'16
  • 77% growth in the number of clinical routine treatments

MALAKOFF, France--()--Regulatory News:

THERACLION (Paris:ALTHE) (Alternext, FR0010120402 - ALTHE), a company specialized in leading-edge medical equipment for echotherapy, today announced its sales for 2017 first half, ended June 30, 2017.

David Caumartin, CEO of Theraclion, declares: « Theraclion accelerates its growth in the first half of 2017 with the signature of 11 commercial agreements1 compared with 5 the previous year over the same period. Germany, where several health insurances already reimburse the procedure, remains the main market for the company. In the first half of the year, the continuing expansion of the number of insurance companies covering the use of echotherapy has driven growth in treatment volumes and allowed the signature of three new commercial agreements. Three orders are registered in new countries, reflecting the growing adoption of our echotherapy solution. Given this dynamic commercial development, Theraclion expects to double the number of commercial agreements1 concluded in 2017 compared to 2016. »

New orders: already 11 commercial agreements1 signed during 2017 first half

During the first half of 2017, the Company recorded 11 commercial agreements1: 8 Echopulse® orders, 2 of which have been already transferred2, and 3 contracts for the provision of equipment against pay per use, including 1 in Hong Kong.

Equipment rent decreased compared to the first half of 2016 due to the exercise of the Echopulse purchase option at two of the three sites leasing Echopulse at the end of the 2016 financial year.

While the number of clinical routine treatments increased by 77%, the sale of consumables decreased by 7% compared to the first half of 2016. As the supply chain matures and the delivery time reduces, customers are maintaining lower inventory levels than they did in 2016.

The increase in service sales reflects the subscription of maintenance contracts for systems that have come out of the warranty period.

Sales growth: 21%

K€   2017   2016   % vs 2016

Equipment sales3

  456   294   +55%
Equipment rent 24 101 -76%
Consumables sales 52 56 -7%
Services sales   28   13   +115%
Total Sales   561   463   +21%

Clinical routine: 77% growth in the number of treatments performed

The total number of treatments increased by 52% in the first half. The number of clinical routine treatments (i.e.: treatments outside a Theraclion-sponsored clinical trial) increased by 77%, reflecting the growing clinical adoption of echotherapy. In Germany, the leading country in terms of number of treatment sites, routine clinical treatment volume increased by 89%.

  June 2017   June 2016   Evolution   % Evolution
Thyroid 168 113 +55 +49%
Breast 63 43 +20 +47%
Other   6   0   +6   NA
TOTAL   237   156   81   +52%

% Treatments outside Theraclion-
sponsored studies

  93%   80%   +1300pts   +13%

Number of treatments outside
Theraclion sponsored studies

221 125 +96 +77%

FDA Authorization to Start U.S. Trial for Immunotherapy and Echotherapy Combination in Breast Cancer Treatment

The University of Virginia (UVA), one of Theraclion’s long-term academic partner, has received authorization from the U.S. Food and Drug Administration (FDA) to proceed with a new clinical study. This study aims at evaluating the potential of treatment combining echotherapy delivered with Theraclion’s Echopulse (also known as High Intensity Focused Ultrasound, HIFU) with pembrolizumab, an immunotherapy drug targeting PD-1 checkpoint Inhibitor. UVA has been equipped with Theraclion’s Echopulse® since 2014. Echopulse is being evaluated in a feasibility study in the US for non-invasive treatment of breast fibroadenomas.

Immunotherapy stimulates the body’s own immune system to fight tumor cells. HIFU, which has already demonstrated its efficacy in the treatment of malignant and benign tumors, could have a major impact on the efficacy of immunotherapy when delivered as a combined treatment as it may locally potentiate the immune response induced by the combined treatment of drugs and HIFU.

Cash Management and Funding

Theraclion also announces that it has obtained new funding under its TUCE project in collaboration with SuperSonic Imagine (Euronext: SSI, FR0010526814, eligible for PEA-PME).

The TUCE project aims to combine the technology of echotherapy with SuperSonic Imagine’s innovative imaging solution of. The effect of the treatment on the tissues can be monitored and validated in real time. This new funding of € 1,036,000 in July from Bpifrance, in the form of recoverable advances of € 703,000 and grants of € 333,000, follows on the € 433,000 received in July 2016. This new funding rewards a key milestone in development that includes the results of clinical trials in Europe and the FDA authorization of the launch of breast fibroadenoma trials in the United States.

«We are delighted to see the advances of TUCE project, which is being promoted by Theraclion as part of our “Industrial Strategic Innovation” program. We support the future champions of the French industry and today we renew our support for Theraclion, which is developing an innovative medical device for the non-invasive treatment of tumors. We look forward to the success of the first treatments», says Nicole Tannières, Head of Follow-up of projects to the Bpifrance Expertise Department.

Theraclion continue its funding efforts to secure its cash needs for 2018.

About Theraclion
Theraclion is a French company specializing in high-tech medical equipment using therapeutic ultrasound. Drawing on leading-edge technologies, Theraclion has designed and manufactured an innovative solution for echotherapy, the Echopulse®, allowing non-invasive tumor treatment through ultrasound-guided high-intensity focused ultrasound. Theraclion is ISO 13485 certified and has received the CE mark for non-invasive ablation of breast fibroadenomas and thyroid nodules. Based in Malakoff, near Paris, France Theraclion has brought together a team of 34 people, 50% of whom are dedicated to R&D and clinical trials. For more information, please visit Theraclion’s website: www.theraclion.com.

Theraclion is listed on Alternext Paris
PEA-PME Eligible
Mnemonic: ALTHE - ISIN Code: FR0010120402

1 Commercial agreements cover sales of equipment and the provision of equipment for which Theraclion invoices either rent or "on a fee" basis.
2 These sales of equipment include a return clause within 12 months. This practice is commonly used by Theraclion to facilitate the adoption of its
innovative technology. To date, no customer has exercised this clause.
3 These sales of equipment include a return clause within 12 months. This practice is commonly used by Theraclion to facilitate the adoption of its innovative technology. To date, no customer has exercised this clause.

Contacts

Theraclion
David Caumartin
CEO
Tel.: +33 (0)1 55 48 90 70
david.caumartin@theraclion.com
or
Kalima
Press Relations
Florence Calba, Tel.: + 33 (0)1 44 90 82 54
fcalba@kalima-rp.fr
or
The Ruth Group (U.S.)
Investor Relations / Public Relations
Robert Flamm / Kirsten Thomas
+1 646-536-7017 / +1 508-280-6592
rflamm@theruthgroup.com / thomas@theruthgroup.com

Contacts

Theraclion
David Caumartin
CEO
Tel.: +33 (0)1 55 48 90 70
david.caumartin@theraclion.com
or
Kalima
Press Relations
Florence Calba, Tel.: + 33 (0)1 44 90 82 54
fcalba@kalima-rp.fr
or
The Ruth Group (U.S.)
Investor Relations / Public Relations
Robert Flamm / Kirsten Thomas
+1 646-536-7017 / +1 508-280-6592
rflamm@theruthgroup.com / thomas@theruthgroup.com