AMT announces full year 2009 results; reports modest decrease in operating expenses

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."

Operations

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.

Results

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.

Subsequent events

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.