AMSTERDAM, August 29 /PRNewswire-FirstCall/ -- Amsterdam Molecular Therapeutics , a leader in the field of human gene therapy, today reported its results for the first half year of 2007.
Highlights
- Successful IPO, raising gross proceeds of EUR 55.7 million
- Cash & cash equivalents of EUR 56.3 million at June 30, 2007
- Exclusive license to all gene therapy products from CIMA, one of Europe's leading gene therapy centers
- U.S. FDA orphan drug designation for lead product AMT 011 - Positive results of Phase I/II in LPL type I deficiency - Pre-registration trial commenced in Canada of AMT 011 in LPL deficiency - Appointment of Ferdinand Verdonck as chairman of supervisory board.
- Global rights for our product AMT 020 for the treatment of acute intermittent porphyria
Results comparison
Total revenues for the six months ended June 30, 2007, were EUR 50,000 compared to EUR 208,000 for the same period in 2006. The decrease was primarily due to a decrease of government grants, since the grant project for LPL deficiency was completed in 2006.
The operating loss increased to EUR 7.2 million for the six months ended June 30, 2007, from EUR 4.2 million for the same period in 2006. This was primarily due to the increase of research & development costs to EUR 3.8 million for the six months ended June 30, 2007 from EUR 1.9 million in the same period of 2006. This increase is particularly related to the development work on the company's lead product AMT 011 for LPL deficiency and increased staffing. General and administrative costs rose primarily as a function of the higher number of staff employed, stock based compensation, increased facility expenses and advisory costs. These costs increased to EUR 3.5 million for the six months ended June 30, 2007, from EUR 2.6 million for the same period in 2006.
The net loss for the first six months was EUR 8.6 million, as compared to a net loss of EUR 3.2 million in the same period of 2006.
As of June 30, 2007, AMT had cash and cash equivalents of EUR 56.3 million, compared to EUR 14.1 million at December 31, 2006.
Recent events
Very recently AMT obtained an exclusive license from Digna Biotech to commercialize all gene therapy products resulting from the R&D activities performed at the Center for the Study of Applied Medicine (CIMA) at the University of Navarra, Spain. Employing more than 400 researchers, CIMA is one of the leading gene therapy research centers in Europe.
"AMT had an excellent first half of 2007, culminating in its listing on Euronext Amsterdam on June 20. The proceeds from this successful initial public offering will be used to accelerate our development programs and build up a marketing and sales infrastructure in anticipation of the expected commercial roll-out of our lead product in 2009. We expect to make considerable progress over the next 12 month related to our clinical programs and business development activities, and look forward to update our investors as these materialize," said Ronald Lorijn, CEO of AMT.
Conference call and webcast presentation
AMT will conduct a conference call open to the public today at 10.00 CET, which will also be webcast. Netherlands dial in: +31-(0)800-949- 4517 (toll free); US dial in: +1-866-291-4166 (toll free); UK dial in: +44- 207-107-0611. The webcast can be accessed on the investors portion of AMT's website at http://www.amtpharma.com. Please go to the website 15 minutes prior to the call to register, download and install the necessary audio software. Playback of the call will be availably for 24 hours after the call. Dial in: +41-91-612-4330; +44-20-7108-6233; or +1-866-416-2558. The archived webcast also will be available for replay shortly after the close of the call.
About Amsterdam Molecular Therapeutics
AMT has a unique gene therapy platform that to date appears to circumvent many if not all of the obstacles that have prevented gene therapy to become a mainstay of clinical medicine. 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. As such, AMT's proprietary platform holds tremendous promise for thousands of rare (orphan) diseases that are caused by one faulty gene. AMT currently has a product pipeline with six products at different stages of development.
Condensed interim financial statements 30 June 2007
The attached consolidated income statement, balance sheet and cash flow statement are derived from our condensed interim financial statements 30 June 2007 which can be found on our website http://www.amtpharma.com
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 reports filed from time to time with Euronext Amsterdam N.V.
AMSTERDAM MOLECULAR THERAPEUTICS HOLDING N.V. Consolidated income statement (In Euro x 1,000) Period ended 30 June 2007 30 June 2006 Revenues - 52 Cost of sales - (42) Gross profit - 10 Other income 50 198 Total net income 50 208 Research and development costs 3,790 1,871 General and administrative costs 3,486 2,559 Total operating costs 7,276 4,430 Operating result (7,226) (4,222) Interest income 230 7 Interest costs (1,644) (51) (1,414) (44) Result on deconsolidation - 1,113 Result before corporate income taxes (8,640) (3,153) Corporate income taxes - - Result for the period (8,640) (3,153) Attributable to: Equity holders of the Company (8,640) (3,153) 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 (0.97) (1.61) AMSTERDAM MOLECULAR THERAPEUTICS HOLDING N.V. Consolidated balance sheet (after appropriation of result) (In Euro x 1,000) 30 June 31 December 2007 2006 ASSETS Non current assets Intangible assets 1,540 1,540 Property, plant and equipment 1,463 1,091 3,003 2,631 Current assets Receivables from related parties 862 1,202 Social security and other taxes 178 276 Other receivables 290 51 Cash and cash equivalents 56,283 14,058 57,613 15,587 Total assets 60,616 18,218 EQUITY Shareholders' equity 52,260 (1,682) Total group equity 52,260 (1,682) LIABILITIES Non-current liabilities Loan from related party - 1,038 Liabilities to preference shareholders - 15,504 Financial lease liabilities 445 498 Other non-current liabilities 903 45 1,348 17,085 Current liabilities Trade payables 674 963 Payables to related parties 1,857 266 Social security and other taxes 186 153 Other current liabilities 4,291 1,433 7,008 2,815 Total liabilities 8,356 19,900 Total equity and liabilities 60,616 18,218 AMSTERDAM MOLECULAR THERAPEUTICS HOLDING N.V. Consolidated cash flow statement (In Euro x 1,000) Period ended 30 June 30 June 2007 2006 Cash flow from operating activities Result before corporate income tax (8,640) (3,153) Adjustments for: - Depreciation 134 118 - Share based payment expenses 1,543 79 - Gain on derecognition financial lease (53) - - Re-purchase of EMT sales rights - 1,736 - Gain on deconsolidation AVP - (1,113) - Changes in working capital 2,767 316 - Interest income/ (expense) 1,414 76 Cash generated from operations (2,835) (1,941) Interest paid - (15) Net cash generated from operating activities (2,835) (1,956) Cash flows from investing activities Purchases of property, plant and equipment (505) (66) Proceeds from sale of property, plant and equipment - - Purchases of intangible fixed assets - - Interest received 230 7 Net cash received in investing activities (275) (59) Cash flow from financing activities Proceeds from issuance of loans - 200 Capital contribution shareholders 45,335 - Net cash used in financing activities 45,335 233 Net (decrease)/ increase in cash, cash equivalents and bank overdrafts 42,225 (1,815) Cash, cash equivalents and bank overdrafts In the beginning of the period 14,058 521 Cash, cash equivalents at the end of the period 56,283 (1,294)
Amsterdam Molecular Therapeutics B.V
CONTACT: For information: Andre Verwei, CFO, +31-20-566-5686,a.verwei@amtbv.com; Hans Herklots, +31-20-566-8125, h.herklots@amtbv.com