Biotech Values

[DewDiligence]

MNTA Reports 3Q08 Results

[No new info in this PR other than the financials. The cash balance at 9/30/08 was $95M; approximately $14M was burned during 3Q08 (down marginally from the $15M burn in 2Q08). Please see actual PR for financial tables.]

http://biz.yahoo.com/pz/081103/153591.html

›Monday November 3, 8:00 am ET

CAMBRIDGE, Mass., Nov. 3, 2008 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (NasdaqGM: MNTA ), a biotechnology company specializing in the detailed structural analysis of complex mixture drugs, today announced its financial results for the third quarter and nine months ended September 30, 2008.

For the third quarter of 2008, the Company reported a net loss of $16.0 million, compared with a net loss of $18.9 million for the same period in 2007. For the nine months ended September 30, 2008, the Company reported a net loss of $44.3 million compared with a net loss of $54.6 million in the same period in 2007. At September 30, 2008, the Company held cash, cash equivalents, and marketable securities of $95.4 million, compared with $135.9 million at December 31, 2007.

``The commercialization and launch of M-Enoxaparin remains our highest priority, and during the third quarter we made significant progress towards that goal,' said Craig A. Wheeler, President and Chief Executive Officer. ``On September 26, our collaborative partner Sandoz submitted an amendment to the M-Enoxaparin ANDA that we believe to be a complete response to the FDA addressing the potential for immunogenicity of the drug product. In addition, a final mandate was issued following the re-affirmation by the U.S. Court of Appeals rendering the Lovenox(r) Orange Book patents unenforceable.'

Highlights of the Quarter:

* On September 26th, we issued an 8-K disclosing that Sandoz had submitted an amendment to the FDA that we believe fully addresses the agency's questions concerning the immunogenic potential of M-Enoxaparin.

* On September 25th, the U.S. District Court of Appeals denied Sanofi Aventis's petition for rehearing in the Lovenox patent dispute. A final mandate was issued on October 2nd, officially rendering the Orange Book patents unenforceable and triggering the start of the 180-day marketing exclusivity period for the first-to-file applicant.

* In August, Teva filed a patent infringement suit against Sandoz and Momenta in response to the ANDA submission for generic Copaxone.

* In July, we presented Phase 1 data demonstrating the potential of M118 as an anticoagulant therapy in acute coronary syndrome at the IXth World Conference on Clinical Pharmacology and Therapeutics Meeting in Quebec City, Canada.

Revenue for the third quarter of 2008 was $3.9 million, compared to $5.1 million for the third quarter of 2007. For each of the nine months ended September 30, 2008 and 2007, revenue totaled $11.6 million. The revenue in both periods consisted of revenue earned from Sandoz, an affiliate of Novartis. The decrease in revenue from the third quarter of 2007 compared to the third quarter of 2008 was due to the timing of development expenditures reimbursable under the Company's collaborations with Sandoz.

Research and development expenses for the third quarter of 2008 were $14.1 million, compared to $19.5 million for the same period in 2007. For the nine months ended September 30, 2008, research and development expenses were $39.9 million, compared to $50.3 million in the comparable period in 2007. The decreases in research and development expenses were primarily due to decreases in manufacturing and process development costs and research conducted by third parties in support of our M356, M-Enoxaparin and M118 programs.

For each of the three months ended September 30, 2008 and 2007, general and administrative expenses totaled $6.3 million. For the nine months ended September 30, 2008, general and administrative expenses were $18.4 million, compared to $22.0 million in the same period of 2007. The decrease in general and administrative expenses for the nine months ended September 30, 2008 compared to the same period in 2007 was primarily due to a decrease in stock-based compensation expense and a reduction in professional fees and other legal expenses.

Conference Call Information

Management will host a conference call on Monday November 3, 2008 at 10:00 am EST to provide an update on the Company and discuss third quarter results. To access the call, please dial [phone] (domestic) or [phone] (international) prior to the scheduled conference call time and provide the access code 3462072. A replay of the call will be available approximately two hours after the conclusion of the call and will be accessible through November 17, 2008. To access the replay, please dial [phone] (domestic) or [phone] (international) and provide the access code 3462072.

A live audio webcast of the call will be available on the ``Investors' section of the Company's website, http://www.momentapharma.com. Please go to the site at least 15 minutes prior to the call in order to register, download, and install any necessary software. An archived version of the webcast will be posted on the Momenta website approximately two hours after the call and will be available through December 4, 2008.

About Momenta

Momenta Pharmaceuticals is a biotechnology company specializing in the detailed structural analysis of complex mixture drugs. Momenta is applying its technology to the development of generic versions of complex drug products, as well as to the discovery and development of novel drugs. Momenta was founded in 2001 based on technology initially developed at Massachusetts Institute of Technology and is headquartered in Cambridge, MA.‹