AMSTERDAM, February 24, 2010 /PRNewswire-FirstCall/ -- Amsterdam Molecular Therapeutics (Euronext: AMT), a leader in the field of human gene therapy, today reported its results for the year to December 31, 2009.
Highlights - Glybera(R) Marketing Authorisation Application submitted to European Medicines Agency (EMA, formerly known as EMEA); - EMA commenced formal review of Glybera(R) dossier on January 20, 2010; - EMA grants orphan drug designation for AMT's Acute Intermittent Porphyria ("AIP") program; - EMA grants orphan drug designation for AMT's Duchenne Muscular Dystrophy ("DMD") program; - SenterNovem awards EUR 4 million investment credit for the development of AMT's DMD program; - Raised EUR 5 million convertible loan notes, which convert into ordinary shares at EUR 3.91 per share; - New management team.
Jorn Aldag, Chief Executive Officer of AMT, commented: "In 2009 we announced a rebalancing of our strategy, focused on our lead product Glybera(R), a proprietary product for lipoprotein lipase deficiency (LPLD), together with the ongoing development of four earlier stage progams targeting: Hemophilia B, Duchenne Muscular Dystrophy (DMD), Acute Intermittent Porphyria (AIP) and Parkinson's Disease. At the end of 2009 we reached a major milestone by submitting the Marketing Authorisation Application (MAA) for Glybera(R) to the European Medicine Agency (EMA), and this dossier was validated by EMA on January 20, 2010. After having de-risked our business model and secured funding into 2011 we are well positioned for the future."
Glybera(R)'s entry into the European registration process is a major milestone. For a large number of serious diseases, therapeutic options are limited to providing symptomatic relief at best. Millions of patients have to rely on continuous medical care to help them manage their life-long complaints. Today, researchers are finally pointing to a number of inspiring successes in gene therapy that carry the excitement of possible cure. Through gene therapy, the body's lack of natural function is restored thus providing a real, longterm solution. Glybera(R) could be the first gene therapy product to treat a genetic disease to be approved for sale in Europe. AMT expects its second gene therapy product to enter clinical development shortly.
Because AMT's technology can be applied equally to a wide range of other genetic diseases, the success of Glybera(R) would validate AMT's approach for its other pipeline products, targeting a range of orphan and major diseases, including Parkinson's Disease, Hemophilia, DMD and AIP.
The Group appointed a new corporate leadership team. In September 2009, AMT announced that Jorn Aldag had been appointed Chief Executive Officer. In December AMT further announced that Piers Morgan had been appointed Chief Financial Officer and Hans Preusting had taken up the responsibility for Operations & Project Management. The new team has de-risked our business model through the focus on key projects and a balanced partnering strategy. And, as a first result, we secured further financing to fund the Company into 2011.
AMT's operating loss reduced slightly to EUR 17.8 million for 2009, from EUR 18.8 million for 2008. Research and development expenditure was maintained at EUR 13.2 million compared to EUR 13.1 million in 2008, and the modest decrease in operating expenses is primarily due to the decrease of general and administrative costs to EUR 4.9 million, from EUR 5.9 million in 2008. This decrease reflected the higher than normal cost of advisory fees in 2008 which did not recur to the same level in 2009. Interest receivable fell to EUR 0.6 million compared to EUR 1.9 million in 2009, reflecting the lower average cash balances of the Group during 2009. Consequently the net loss for 2009 was EUR 17.2 million, broadly in line with the net loss of EUR 16.9 million for 2008.
In December 2009 AMT successfully raised EUR 5 million of new funds via a private placement of convertible bonds. The five-year unsecured and unsubordinated bonds, which have a minimum denomination of EUR 100,000, had an issue price of 100% and pay an annual coupon of 5%. During the conversion period the bonds are convertible into ordinary shares of AMT at an initial conversion price of EUR 3.91 or a 30% premium over the then prevailing share price.
As of December 31, 2009, AMT had cash and cash equivalents of EUR 22.6 million, compared to EUR 34.2 million at December 31, 2008. The net cash burn for the year amounted to EUR 11.5 million.
On January 6, 2010 AMT announced that it will receive an Innovation Credit of up to EUR 4 million from the Dutch government to support the development of AMT's gene therapy treatment for Duchenne Muscular Dystrophy (DMD) The credit is granted by SenterNovem and will fund 35% of the program costs during the period to mid-2013.
About Amsterdam Molecular Therapeutics
AMT, founded in 1998 and based in Amsterdam, is a leader in the development of human gene based therapies. Using adeno-associated viral (AAV) vectors as the delivery vehicle of choice for therapeutic genes, the company has been able to design and validate what is probably the first stable and scalable AAV production platform. This safe and efficacious proprietary platform offers a unique manufacturing capability which can be applied to a large number of rare (orphan) diseases that are caused by one faulty gene. Currently, AMT has a product pipeline with several AAV-based gene therapy products in LPL Deficiency, Hemophilia B, Duchenne Muscular Dystrophy, Acute Intermittent Porphyria and Parkinson's Disease at different stages of research or development.
Certain statements in this press release are "forward-looking statements" including those that refer to management's plans and expectations for future operations, prospects and financial condition. Words such as "strategy," "expects," "plans," "anticipates," "believes," "will," "continues," "estimates," "intends," "projects," "goals," "targets" and other words of similar meaning are intended to identify such forward-looking statements. Such statements are based on the current expectations of the management of Amsterdam Molecular Therapeutics only. Undue reliance should not be placed on these statements because, by their nature, they are subject to known and unknown risks and can be affected by factors that are beyond the control of AMT. Actual results could differ materially from current expectations due to a number of factors and uncertainties affecting AMT's business, including, but not limited to, the timely commencement and success of AMT's clinical trials and research endeavors, delays in receiving U.S. Food and Drug Administration or other regulatory approvals (i.e. EMEA, Health Canada), market acceptance of AMT's products, effectiveness of AMT's marketing and sales efforts, development of competing therapies and/or technologies, the terms of any future strategic alliances, the need for additional capital, the inability to obtain, or meet, conditions imposed for required governmental and regulatory approvals and consents. AMT expressly disclaims any intent or obligation to update these forward-looking statements except as required by law. For a more detailed description of the risk factors and uncertainties affecting AMT, refer to the prospectus of AMT's initial public offering on June 20, 2007, and AMT's public announcements made from time to time.
Consolidated balance sheet (after appropriation of result) (In EUR x 1,000) December 31, December 31, 2009 2008 ASSETS Non-current assets Intangible assets 3,008 2,497 Property, plant and equipment 1,756 2,338 4,764 4,835 Current assets Receivables from related parties 34 44 Social security and other taxes 414 102 Other receivables 469 1,048 Cash and cash equivalents 22,624 34,150 23,541 35,344 Total assets 28,305 40,179 EQUITY Shareholders' equity 18,410 35,105 Total group equity 18,410 35,105 LIABILITIES Non-current liabilities Financial lease liabilities 259 341 Debt to related party 4,723 - Other non-current liabilities - 110 4,982 451 Current liabilities Trade payables 1,182 1,178 Payables to related party - 219 Social security and other taxes 215 154 Other current liabilities 3,516 3,072 4,913 4,623 Total liabilities 9,895 5,074 Total equity and liabilities 28,305 40,179 Consolidated income statement (In EUR x 1,000) Year ended December 31, December 2009 31, 2008 Other income 355 223 Total net income 355 223 Research and development costs (13,241) (13,118) General and administrative costs (4,913) (5,895) Total operating costs (18,154) (19,013) Operating result (17,799) (18,790) Interest income 647 1,901 Interest costs (23) (30) 624 1,871 Result before corporate income taxes (17,175) (16,919) Corporate income taxes - - Result for the year (17,175) (16,919) Attributable to: Ordinary shareholders of the Company (17,175) (16,919) Earnings per share for result attributable to the equity holders of the Company during the period (expressed in Euro per share) Basic and diluted earnings per share (1.17) (1.16) Consolidated cash flow statement (In EUR x 1,000) Year ended December 31, 2009 December 31, 2008 Cash flow from operating activities Result before corporate income tax (17,175) (16,919) Adjustments for: - Depreciation 688 653 - Share-based payment expenses 440 (266) - Changes in working capital 165 517 - Interest (income)/expense (624) (1,871) Cash used in operations (16,506) (17,886) Interest paid (23) (2) Net cash generated from operating (16,529) (17,888) activities Cash flow from investing activities Purchases of property, plant and (106) (889) equipment Purchases of intangible fixed (511) (600) assets Interest received 857 1,901 Net cash used in investing 240 412 activities Cash flow from financing activities Capital contribution shareholders 40 296 Convertible loans drawn down, net 4,723 - of costs Net cash generated from financing 4,763 296 activities Net (decrease)/ increase in cash, cash equivalents and bank overdrafts (11,526) (17,180) Cash, cash equivalents and bank overdrafts At the beginning of the year 34,150 51,330 Cash, cash equivalents at the end 22,624 34,150 of the year
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