September 17, 2012 -- CARMAT (FR0010907956, Paris:ALCAR), the designer and developer of the world's most advanced total artificial heart project, providing an alternative for people suffering from terminal heart failure, today announces its results for the first half to June 30, 20121.
2012 half-year results
Over the 1st half of 2012, CARMAT recorded operating income of ?7 thousand, which consisted entirely of ANRT2 subsidies to support the internship of a PhD student. No other income was recorded by the Company over the 1st half of 2012, with CARMAT's total artificial heart project still in its development phase.
Operating expenses came to ?12.6m over the half year. The 35% increase compared to the 1st half of 2011 is in line with the developments achieved by the Company, and reflects the importance of this phase to prepare for clinical trials and prosthesis industrialisation. Substantial efforts were devoted to the quality assurance system, the industrialisation process and the development of external systems for the return home of the first patients.
Once a Research Tax Credit of ?1.7m is taken into account, the net loss for the 1st half of 2012 was ?10.7m.
Solid cash position at end-June 2012
At June 30, 2012, cash and marketable cash instruments totalled ?16.6m.
The available cash at that date does not include the ?2.6m received in July 2012 relating to the 2011 Research Tax Credit.
CARMAT reminds the reader that the payment of ?2.9m in subsidies and ?3.8m in repayable advances, in accordance with the amendment to the master agreement signed with OSEO, is conditional upon the completion of the next key stage (EC4) of the project which consists in submitting the full in-vitro preclinical trial file; these trials, and notably the endurance tests, are currently nearing completion.3
H1 2012 highlights and recent events
A scientific publication by the Company was accepted and published in the European Journal of Cardio-Thoracic Surgery in June 20124. This publication follows CARMAT's oral presentation at the 25th annual meeting of the European Association for Cardio-Thoracic Surgery (EACTS) in Lisbon in October 2011, regarding the in-vitro haemocompatibility of the bioprosthetic blood-contacting surfaces of the Carmat Total Artificial Heart (press release of October 3, 2011).
Winner of the Best Technology category at the European Mediscience Awards
CARMAT was named best European company in the Best Technology category at the 10th annual European Mediscience Awards, which were held in London on June 21, 2012. The voting panel, consisting of European finance and life science professionals, chose CARMAT for the highly innovative nature of its total artificial heart project and its ability to generate significant future commercial success.
Intermediary results of the endurance tests
CARMAT has to provide the ANSM with a report on the endurance tests undergone by each of five complete systems - incorporating the heart and all of its external components - over a continuous four-month period to complete the file. Encouraging intermediary results were added to the file registered with the ANSM on July 26. The delay in the test schedule, and therefore the carrying out of the first implants, is notably a result of the time required to validate the industrial processes with our partners. The tests on the five prostheses currently on the test benches are progressing well.
In-vivo implants and training of surgical teams
Between January and June 2012, CARMAT successfully implanted its prostheses on several calves. The aim was to validate their smooth-running in-vivo and to train the three medico-surgical teams chosen for the first clinical phase - the Georges Pompidou European Hospital in Paris, the Centre Chirurgical Marie Lannelongue hospital in Plessis Robinson and the Hôpital Nord Laënnec university hospital in Nantes - in surgical techniques. The results obtained, announced on July 26, met the protocol's objectives: starting up and smooth running of the prosthesis, and generation of physiological blood flow and pressures.
2011 Reference Document
The Company's 2011 Reference Document was registered with the Autorité des Marchés Financiers on September 12, 2012 under n° R.12-044, and is available on both the CARMAT website (www.carmatsa.com) and the Autorité des Marchés Financiers website (www.amf-france.org).
Marcello Conviti, Chief Executive Officer of CARMAT, concludes: "The results for the 1st half of 2012 reflect the emphasis and care we put in the preparation of the next phases of our project. The support of internationally-recognised surgical teams and the progresses made in the endurance tests, the final step before the completion of the preclinical trials, highlight the extensive work carried out by the men and women who are a part of this unique project, and foster our confidence to enter its next stages."
Detailed and comprehensive information regarding the results for the 1st half of 2012 can be found in the half-year financial report to June 30, 2012, which is available on CARMAT's website (www.carmatsa.com), Investors / Documentation / Financial reports.
About CARMAT: CARMAT, the world's most advanced total artificial heart project
The only credible response for all cases of end-stage heart failure - a true public health issue: CARMAT's ultimate aim is to provide a response to a major public health issue associated with cardiovascular disease, the world's leading cause of death: heart failure. This disease currently affects over 20 million patients in Europe and the United States. By pursuing the development of its total artificial heart, CARMAT intends to overcome the well-known shortfall in heart transplants for the tens of thousands of people suffering from end-stage heart failure.
The result of combining two types of unique expertise: the medical expertise of Professor Carpentier, known throughout the world for inventing Carpentier-Edwards® heart valves - most widely used worldwide - and the technological expertise of EADS, a global aerospace leader.
Imitating the natural heart: Given its size and weight, the choice of structural materials and its innovative physiological functions, CARMAT's total artificial heart could, assuming upcoming clinical trials are successful, potentially benefit tens of thousands of patients a year - with no risk of rejection and providing them with unparalleled quality of life.
A project leader acknowledged at the European level: with the backing of the European Commission, CARMAT has received the largest grant-in-aid (a total of ?33m) made to an SME by OSEO (the French state innovation agency).
Strongly committed, prestigious founders and shareholders: Truffle Capital (the leading European venture capital firm), EADS, the Foundation Alain Carpentier, the Marie Lannelongue Cardiothoracic Centre and thousands of institutional and individual shareholders have placed their trust in CARMAT.
For further information, visit: www.carmatsa.com
This press release and the information contained herein do not constitute an offer to sell or subscribe to, or a solicitation of an offer to buy or subscribe to, shares in CARMAT ("the Company") in any country. This press release contains forward?looking statements that relate to the Company's objectives. Such forward?looking statements are based solely on the current expectations and assumptions of the Company's management and involve risk and uncertainties. Potential risks and uncertainties include, without limitation, whether the Company will be successful in implementing its strategies, whether there will be continued growth in the relevant market and demand for the Company's products, new products or technological developments introduced by competitors, and risks associated with managing growth. The Company's objectives as mentioned in this press release may not be achieved for any of these reasons or due to other risks and uncertainties. No guarantee can be given as to any of the events anticipated by the forward-looking statements, which are subject to inherent risks, including those described in the Document de Référence registered with the Autorité des Marchés Financiers under number R.12-044 on September 12, 2012 and the Note d'Opération that was approved with visa no. 11-308 on July 11, 2011, changes in economic conditions, the financial markets or the markets in which Carmat operates. In particular, no guarantee can be given concerning the Company's ability to finalize the development, validation and industrialization of the prosthesis and the equipment required for its use, to manufacture the prostheses, satisfy the requirements of the AFSSAPS, enroll patients, obtain satisfactory clinical results, perform the clinical trials and tests required for CE marking and to obtain the CE mark.
1 Half-year accounts were approved by the Board on September 13, 2012.
2 Association Nationale de la Recherche et de la Technologie
3 To date, ?3m in subsidies and ?10.8m in repayable advances are still due to be received within the framework of the OSEO contract, the end-result of which should be the granting of the CE mark.
4 Jansen P, van Oeveren W, Capel A, Carpentier A. In vitro haemocompatibility of a novel bioprosthetic total artificial heart. Eur J Cardiothorac Surg. 2012 Jun;41(6):e166-72
Marcello Conviti, CEO
Patrick Coulombier, COO
Valérie Leroy, +33 (0)1 39 45 64 50
Marketing and Investor Relations Director
Caroline Carmagnol, +33 (0)6 64 18 99 59
Financial communication and investor relations
Dusan Oresansky / Emmanuel Huynh, +33 (0)1 44 71 94 94