Saint-Genis-Pouilly, France -- (ReleaseWire) -- 07/10/2014 -- Highlights
- Sales up 31.77% to €53.8 million
- Pivotal Phase III trial for Lu-DOTATATE (Lutathera®) progressing as planned
- Key pipeline products Ga-68 DOTATATE (Somakit®) and 99mTc-rhAnnexin V-128 progressing well
- Orphan Drug Designation obtained for Ga-68 DOTATATE from FDA and EMA
- Continued expansion of network in Europe and the US
- Acquired IEL and entered UK and Irish markets
- Strong presence in Europe’s G5
- Strengthened presence in the US
- Completed a capital increase of €41 million
- 4 new Board members elected
Advanced Accelerator Applications S.A. (“AAA” or “the Company”), an international specialist in Molecular Nuclear Medicine (MNM), is pleased to announce its results for the financial year 2013, with sales of €53.8 million (+31.77% vs. 2012). Other key news includes the appointment of four new independent Directors to AAA’s Board.
2013 financial performance
AAA shareholders approved the Company’s financial results for 2013. Sales for the year increased by 31.77% to €53.8 million (2012: €40.8 million). EBITDA, including costs of employee share-based payments, increased by 61.74% to €10.64 million (2012: €6.58 million) with net income representing a loss of €9.86 million for the year 2013 (vs loss of €16.91 million in 2012). Increased sales forecasts for Lu-DOTATATE compared to 2012 resulted in significant financial charges i.e. AAA has contractual obligations to pay royalties on sales of Lu-DOTATATE once the Company obtains Market Authorization and these estimated obligations need to be accounted for as a financial debt, these explain almost entirely the negative net income for 2013. These financial obligations based on sales estimates of Lutathera also explained for the most part the negative 2012 net income. Cash and cash equivalents were €13.6 million at the end of 2013, essentially the same as at the end of 2012. Net operating cash-flow was €11.94 million, an increase of 82.5% compared to the €6.52 million in 2012.
AAA’s CEO Stefano Buono commented: “2013 was a very good year for AAA. We exceeded our financial targets with strong demand for our existing products and we consolidated our presence in Europe. With Lu-DOTATATE, our product candidate currently in Phase III, we believe we are well positioned for future success.”
In 2013 AAA continued the expansion of its European MNM network with the creation of AAA Poland and the signing of an agreement with the University of Warsaw to operate its production site in 2014. A €4.8 million capital increase was completed in April 2013 to help fund expansion plans and finance clinical trials of a promising portfolio of MNM product candidates.
AAA’s proprietary pipeline continued to show progress with the Lu-DOTATATE pivotal Phase III trial recruitment on-track and other key pipeline products Ga-68 DOTATATE and 99mTc-rhAnnexin V-128 also progressing well.
In early 2014 AAA acquired Imaging Equipment Limited (IEL) giving the Company its first direct presence in the UK and Ireland, and a strong presence in all Europe’s G5 countries. AAA continued its global expansion with the opening of an office in New York to support ongoing clinical studies for Ga-68 DOTATATE and Lu-DOTATATE. The NY office will be instrumental in overseeing the launch of AAA’s commercial activity in North America. AAA also recently started operations in its new French site in Marseille which produced and delivered its first doses of GLUSCAN® on 12 May 2014.
A €41 million capital increase, that included specialist biotech and pharma investment company HBM Healthcare Investments Ltd as a cornerstone investor, was completed on February 14, 2014 and, most recently, Ga-68 DOTATATE obtained Orphan Drug Designation from the FDA and EMA.
Appointment of four new Board members
During AAA’s Annual General Meeting, the Shareholders approved the appointment of Yvonne Greenstreet, Steven Gannon, Christian Merle and Leopoldo Zambeletti as Non-Executive Directors. They joined Stefano Buono, Kapil Dhingra, Muriel de Szilbereky and Claudio Costamagna to form a new eight person Board of Directors chaired by Claudio Costamagna. All Board Members are elected for the duration of one year. Renewal of the mandate is subject to shareholder approval.
Gerard Ber, Heinz Mausli, Eugenio Aringhieri, Andrea Ruben Levi and Raffaele Petrone stepped down from the Board.
“We are delighted to welcome our four new members to AAA’s Board of Directors,” said Stefano Buono, CEO of AAA. “As the business of AAA becomes increasingly global, Board members with their breadth of experience are essential assets to the organization. These highly successful leaders will play a vital role in guiding AAA in its mission to become a leading global player in MNM. I would also like to extend my thanks and appreciation to those Board members stepping down for the time and energy they have devoted to AAA during their tenure as Board members. During the many years that they devoted to our Company, thanks to their contribution, AAA has been able to successfully grow internationally and rapidly become a European leader in MNM.”
Dr Yvonne Greenstreet has over 20 years of global experience in the pharmaceutical industry, where she has a proven track record as a business leader and drug developer. Dr. Greenstreet was a senior vice president and the Head of Medicines Development at Pfizer from 2010 to 2013. Prior to joining Pfizer, Dr. Greenstreet served in various roles at GlaxoSmithKline from 1992 to 2010, including Chief Medical Officer for Europe and Chief of Strategy. Dr. Greenstreet serves on the Advisory Board of the Bill and Melinda Gates Foundation and as a member of the Board of Directors of Pacira. She completed her medical training at the University of London Hospitals and received her MBChB from the University of Leeds. She subsequently completed a master’s in business administration at INSEAD.
Steven Gannon has extensive financial experience in corporate growth initiatives such as acquisitions, corporate alliances, and partnerships within the biotechnology and pharmaceutical sector. Mr Gannon is a Senior Vice President and the Chief Financial Officer and Treasurer at Aptalis Pharma Inc. Prior to joining Aptalis Pharma Inc., Mr. Gannon served as the Chief Financial Officer for Cryocath Technologies, Inc. from 1999 to 2006, as the Director of Finance and Administration of the Research Division of Astrazeneca Canada Inc. from 1996 to 1999, and as the Chief Financial Officer of Mallinckrodt Medical Inc.’s Canadian operations from 1989 to 1995. He received a bachelor of commerce in accounting and business systems from Concordia University in Montreal and completed the Executive Program at the Richard Ivey School of Business at the University of Western Ontario. He is also a chartered accountant.
Leopoldo Zambeletti is a highly respected figure within the life sciences sector. During a 19-year career as an investment banker, he led the European Healthcare Investment team at JP Morgan for eight years before taking up the same position at Credit Suisse for a further five years. Since 2013 Mr Zambeletti has been an independent strategic advisor to life science companies on Merger and Acquisitions, out-licensing deals and financing strategy. He is a Non-Executive Director of Summit Corporation plc. and Nogra Pharma and an advisor to the US medtech company Qardio. He serves as a trustee to Barts and the London Charity which helps fund the hospitals of the Barts NHS Trust including St Bartholomew’s, the Royal London and the London Chest Hospitals. He is a founder of the cultural initiative 5x15 Italy.
Christian Merle has 37 years of experience in Commercial, Private and Investment banking and is currently Managing Partner at Merle & Partners, Advisory. He has held senior leadership roles in a number of leading banks in France, Italy and Switzerland. Prior to founding Merle & Partners, Mr. Merle was the Chief Executive Officer of Banque Espirito Santo from 2007 to 2013, the Managing Partner of Gimar & Cie from 2003 to 2007 and the Chief Executive Officer of Banca Intesa from 1998 to 2003. Prior to joining Banca Intesa, he served in various roles at Credit Agricole, including as the Executive Vice President of Credit Agricole Indosuez. He also served in various roles in the French Treasury, including the Chief Representative in the United States from 1987 to 1990. He received his undergraduate degree from the Institut d’Etudes Politique and a master’s in economics from the Université de Paris I-Panthéon Sorbonne.
About Advanced Accelerator Applications
Advanced Accelerator Applications (AAA) is a radiopharmaceutical company founded in 2002 to develop innovative diagnostic and therapeutic products. AAA’s main focus is in the field of Molecular Imaging and targeted, individualized therapy for the management of patients with serious conditions (“Personalized Medicine”). AAA currently has 17 production and R&D facilities able to manufacture both diagnostics and therapeutic MNM products, and has over 300 employees in 11 countries (France, Italy, UK, Germany, Switzerland, Spain, Poland, Portugal, Israel, U.S. and Canada). In 2013 AAA reported sales of €53.8 million (+31.77% vs. 2012). For more information please visit: http://www.adacap.com
AAA has a portfolio of Molecular Nuclear Medicine products and product candidates, including Lu-DOTATATE, currently in a pivotal Phase III clinical trial for the treatment of GEP-NETs (an orphan disease) in 51 clinical centers in the United States and European Union. Lu-DOTATATE is an example of a theragnostic product candidate because it integrates diagnostic and therapeutic properties into the same compound, allowing physicians to evaluate and monitor its efficacy using imaging at every therapeutic injection, without additional product costs. Enrollment for the ongoing Lu-DOTATATE Phase III clinical trial (study known as Netter-1) is currently going as planned with over 220 individuals enrolled to date.
About Molecular Nuclear Medicine (“MNM”)
Molecular Nuclear Medicine is a medical specialty using trace amounts of active substances, called radiopharmaceuticals, to create images of organs and lesions and to treat various diseases, like cancer. The technique works by injecting targeted radiopharmaceuticals into the patient’s body that accumulate in the organs or lesions that reveal specific biochemical processes.
Molecular Nuclear Diagnostics employs a variety of imaging devices and radiopharmaceuticals. PET (Positron Emission Tomography) and SPECT (Single Photon Emission Tomography) are highly sensitive imaging technologies that enable physicians to diagnose different types of cancer, cardiovascular diseases, neurological disorders and other diseases in their early stages.
Reconciliation of EBITDA to net income (loss) for the year from continuing operations
Year Ended December 31
Net income /(loss) for the year from continuing operations (9,861) (16,912)
Finance income (387) (232)
Finance costs 10,155 16,512
Income taxes 1,059 586
Depreciation and amortization expense 9,672 6,623
EBITDA 10,638 6,577
Cautionary Statement Regarding Forward-Looking Statements
This press release may contain forward-looking statements. All statements, other than statements of historical facts, contained in this press release, including statements regarding the Company's strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements reflect the Company's current expectation regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, EMA, U.S. FDA and other regulatory approvals for our product candidates, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, and uncertainties related to the regulatory approval process or the ability to obtain drug product in sufficient quantity or at standards acceptable to health regulatory authorities to complete clinical trials or to meet commercial demand. Except as required by applicable securities laws, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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