MALAKOFF, France--(BUSINESS WIRE)--Regulatory News:
THERACLION (Paris:ALTHE) (Alternext, FR0010120402 – ALTHE), a company specialized in leading-edge medical equipment for echotherapy, today announced its consolidated results for the financial year ended 31 December 2016, approved by the Board of Directors on 23 March 2017. The 2016 consolidated financial statements have been audited and the auditors’ report will be issued after validation of the Management Report.
David Caumartin, Chief Executive Officer of Theraclion, said: “In 2016 we significantly strengthened our scientific credentials and our market access, especially in Germany and in France. The study by Prof. Lang of Hong Kong University is the most extensive study to date and has the best clinical results, which will enable us to step up our growth on Asian markets and more generally in all regions with a high incidence of thyroid pathologies. In 2017 we anticipate further growth in sales, in our installed base and in treatments, which already advanced strongly in 2016.”
2016 consolidated results
|In thousands of euros||31/12/2016||31/12/2015||Change|
|Total operating revenue||2,032||1,597||27%|
|Purchases of goods||(1,006)||(1,027)||(2%)|
|Other operating expenses||(523)||(499)||5%|
|Net financial items||(230)||(178)||29%|
|Net non-recurring items||(18)||
|Research tax credit||1,212||826||47%|
|Average headcount (FTE)||34||30||13%|
Further sales growth in 2016
Theraclion reported 2016 revenue of €1,889,000, an 8% increase on 2015, when sales amounted to €1,5331,000 plus non-recurring revenue of €217,000 from the sale of a previously installed system for clinical trials. Theraclion made seven sales in 2016 and signed five commercial agreements giving access to echotherapy in clinical routine1. These commercial agreements, limited in time, generate revenues from equipment rental and consumables which could potentially become system sales.
The growth in uptake of the Echopulse® solution is mainly due to support from opinion leaders (seven well-known scientific publications in 2016), a fivefold reduction in treatment times thanks to the new BEAMOTION procedure and development of the thyroid indication, the excellent clinical results of which have convinced a number of prestigious facilities such as the Bürgerhospital in Frankfurt, which decided to buy the Echopulse® system after renting it for one year.
Disciplined cost control
Theraclion is continuing its commercial and R&D efforts, while keeping a firm grip on costs and operating expenses. Those costs are rising in line with the headcount, which went from 30 in 2015 to 34 in 2016.
Purchases of goods were down 2% at €1,006,000 and other purchasing and external expenses were up 1% at €3,826,000 compared with 2015 despite the rise in sales, the company having internalized a certain number of tasks. Other operating expenses amounted to €4,969,000 compared with €4,023,000 in 2015, an increase of 24%, mainly due to a higher headcount and the recruitment of staff at the beginning of 2016, whereas recruitment had been gradual in 2015. The company maintained its policy of sustained investment, with R&D expenditure rising from €2.6 million in 2015 to €3.2 million. Over 50% of staff are involved in R&D.
After including net financial expense of €230,000, mainly due to interest on the TUCE repayable advance and a tax credit of €1,212,000, up 47%, the company made a net loss of €6,806,000 as opposed to a net loss of €6,413,000 in 2015.
At 31 December 2016, Theraclion had available cash of €6,990,000 versus €3,753,000 at 31 December 2015.
For information, in 2016 Theraclion successfully completed a capital increase with preferential subscription rights, raising a final gross amount of €9.6 million. The Chinese group Furui Medical Sciences, a leading player in the Chinese healthcare industry, subscribed 51.6% of the issue, making it the company’s second-largest shareholder with a stake of nearly 19%.
Major events in 2016
71% increase in the number of routine clinical treatment sites
At end-2016, Theraclion’s echotherapy solution was available to patients at 24 centers (16 which own their system and 8 on a rental or pay-per-use basis): eleven in Germany, four in France, two in the United Kingdom, one in Spain, two in Italy, one in Romania, one in Turkey, one in Switzerland and one in Hong Kong.
Germany, with 11 Echopulse® systems installed, faster access to reimbursement by insurance companies and a 56% increase in sales, remains Theraclion’s main target market. These results reflect the number and quality of clinical trials carried out there and the presence of a direct sales force which attends major national medical congresses.
Extended commercial presence and four new regulatory approvals
In 2016 Theraclion expanded its commercial presence in two new countries, Singapore and Romania. In addition, three new regulatory approvals were obtained in 2016 in Singapore, Thailand, Saudi Arabia, and one in January 2017 in South Korea.
Major advances in reimbursement in France and Germany
In France, the French’s National Health Authority (HAS) issued a positive opinion in late December 2016 for the exceptional reimbursement of the Echopulse® medical device for the treatment of breast fibroadenomas within the framework of the ‘Forfait Innovation’ medico-economic study.
In Germany, there has been an acceleration of the expansion of health insurance coverage to 12 million people insured for Echopulse® treatment today, against 1.5 million at the end of 2015. In September 2016, the German insurance company Allgemeine Ortskrankenkasse (AOK) Bremen/Bremerhaven, the largest insurer in the Bremen region, signed a reimbursement agreement for the treatment by echotherapy of thyroid nodules and breast fibroadenomas. In January 2017, the insurance company Die Techniker (TK), one of Germany's largest insurance companies with almost 9.7 million policyholders, confirmed that it was reimbursing the echotherapy treatment for thyroid nodules.
Recent events (since the close of the 2016 fiscal year)
Recruiting starts for FDA’s multicenter pivotal clinical trial in the United States
As part of the pivotal clinical trial evaluating the safety and efficacy of Echopulse® echotherapy as a non-invasive treatment of breast fibroadenomas (FA), Theraclion began the treatment of first patients in the United States in January 2017.
The prospective clinical trial will enroll approximately 100 patients in four centers in the United States, at the University of Virginia School of Medicine (UVA), at NYU Langone Bellevue, Montefiore Medical Center (NY) and the medical center of the University of New York Presbyterian / Columbia, and one in Europe at the Tübingen University Hospital in Germany. Patients will receive a single Echopulse® treatment with high intensity focused ultrasound. The primary assessment criterion is a reduction in the volume of the fibroadenoma, as well as in pain and anxiety. The US market for alternative non-invasive fibroadenoma treatments is large. There are around 400,000 surgeries to remove fibroadenomas in the United States every year.
Clinical development continues
Numerous studies and publications have confirmed that the scientific community is highly interested in echotherapy as an innovative and alternative solution to surgery.
- In January 2017 the American Association of Clinical Endocrinologists (AACE), the American College of Endocrinology (ACE) and the Italian Association of Medical Endocrinology (MEA) published guidelines for the diagnosis and management of thyroid nodules confirming that “treatments by thermal ablation guided by ultrasound (such as the echotherapy) may be considered for symptomatic, solid or mixed benign thyroid nodules”.
In March 2017, the publication of the first Asian study showed that
echotherapy using Echopulse® could significantly reduce the size of
large benign thyroid nodules. The study, entitled “Single-Session high
intensity focused ultrasound (HIFU) treatment in large-sized benign
thyroid nodules” was published on March 2, 2017 in the journal Thyroid
of the American Thyroid Association (ATA).
The 73-patient trial demonstrated the efficacy of a single treatment session using the Echopulse® echotherapy system to treat small and large benign nodules, with success being defined as a reduction of over 50% of the volume of the nodule after six months. The overall median shrinkage at six months was 68.3%. The treatment was well tolerated by patients, without any serious side effects being reported.
Signature of a commercial agreement with the Pitié-Salpêtrière hospital, AP-HP, in Paris
In January 2017, Theraclion signed an agreement with the Thyroid-Endocrine tumors unit of the Institute of Endocrinology, Metabolic Diseases and Internal Medicine (E3M Institute) of the Pitié-Salpêtrière AP-HP hospital in Paris that grants patients access to echotherapy for the treatment of thyroid nodules. The E3M Institute is one of the few expert centers in Europe offering a full range of thermal ablation techniques. The system is available since early 2017 in the E3M Institute's Thyroid-Endocrine tumors unit, which is headed by Professor Laurence Leenhardt.
Expansion continues in Germany
A commercial agreement was signed in January 2017 with the Frankfurt University Hospital following the first clinical trials of echotherapy treatments, which resulted in several scientific publications. The German Center for Thermal Ablation (DTZA) of the University Hospital offers echotherapy in clinical routine for the treatment of thyroid nodules. DTZA is the first institution in Germany to offer its patients a full range of thermal ablative technologies such as echotherapy, radiofrequency and microwave. This agreement was for the tenth system installed in Germany, which is the country with the largest number of Echopulse® systems installed.
BKK VBU, a health insurance company covering half a million Germans, recently joined the integrated care contract for the echotherapy of thyroid nodules. Initially, the insurer only covered the treatment of breast fibroadenomas, but now its policyholders will also be reimbursed for the cost of thyroid nodule echotherapy.
In March, Theraclion won the Gold German Stevie Awards for the Echopulse® system, its non-invasive solution for the treatment of breast fibroadenomas and thyroid nodules, which has enjoyed very strong take-up in Germany. Each year the award is given to companies, organizations or individuals for remarkable projects.
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
Mnemonic: ALTHE - ISIN Code: FR0010120402
1 Treatments in clinical routine generate payment by the
patient or a paying agency, in contrast to the clinical trials
subsidised by Theraclion.
2 Theraclion had non-recurring revenue of €217,000 in 2015, corresponding to the sale to a private clinic of a system previously installed in a European university for clinical trials.