Momenta Pharmaceuticals, Inc. (MNTA)

[DewDiligence]

MNTA Reports 1Q13 Results

[Cash at 3/31/13 (including $20M restricted cash) was $344.2M; cash-usage guidance for 2013 remains $20-24 per quarter or $80-90M for the year. The one notable clinical change is that the M402 phase-1/2 trial in pancreatic cancer will now include Abraxane + Gemzar as the baseline therapy (rather than Gemzar alone); the timeline for finishing the phase-1 (open-label) portion of the trial has been pushed back to 1H14 from the prior guidance of 1H13.]

http://finance.yahoo.com/news/momenta-pharmaceuticals-reports-first-quarter-120000350.html

›30-Aprl-2013 8:00 am ET

CAMBRIDGE, Mass., April 30, 2013 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (MNTA), a biotechnology company specializing in the characterization and engineering of complex drugs, today reported its financial results for the quarter ended March 31, 2013.

For the first quarter of 2013, the company reported a net loss of $24.1 million, or ($0.48) per share, compared to a net loss of $5.0 million, or ($0.10) per share, for the same period in 2012. At March 31, 2013, the company had cash, cash equivalents, and marketable securities of $324.2 million, compared to $340.6 million at December 31, 2012.

"During the first quarter of 2013, we continued to aggressively pursue the advancement of our programs and achievement of our corporate objectives for the year," said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. "We remain in a strong financial position as we deploy our resources to secure approval of the ANDA for generic Copaxone, develop three products in our biosimilar collaboration with Baxter, develop our novel oncology product M402, and advance our research in our sialylation technology research program. We continue to work with regulators to navigate the evolving biosimilars pathway, and to tailor our innovative technology to develop important biosimilars and potentially interchangeable biologics."

First Quarter Highlights and Recent Progress

Complex Generics:

M356, generic version of Copaxone(R) (glatiramer acetate injection)

The ANDA for M356 continues to be under review by the U.S. Food and Drug Administration.
U.S. Court of Appeals for the Federal Circuit (CAFC) scheduled oral arguments for May 7, 2013 in the patent litigation brought by Teva Pharmaceuticals against Momenta and Sandoz. Based on the date of oral arguments, the company expects an appellate decision in the second half of 2013.

Enoxaparin Sodium Injection program update

In the first quarter of 2013, Momenta earned $5.4 million in Enoxaparin Sodium Injection product revenues based on Sandoz-reported net sales of $47 million.
In January, Amphastar and Actavis filed a motion for summary judgment in the District Court following the decision last year from the CAFC. The District Court is considering Momenta's discovery motions prior to considering Amphastar's motion for summary judgment. Teva in the parallel suit also filed a motion for summary judgment. Oral argument on Teva's motion is scheduled for May.
In February, Momenta filed a petition for a writ of certiorari for review of the CAFC decision by the United States Supreme Court in its patent infringement suit against Amphastar and Actavis. In April, the Supreme Court asked Amphastar and Actavis to respond to Momenta's filing in May 2013.

Biosimilars and Potentially Interchangeable Biologics:

Momenta continues to invest in its biosimilar program to advance the three products currently under development: M923, M834 -- two products targeting autoimmune and inflammatory indications -- and M511 -- a monoclonal antibody for oncology. The company is on track to submit an Investigational New Drug (IND) application in 2014 for its lead biosimilar M923, and is also targeting achievement of development criteria that would generate a license payment and a milestone payment for M511 and M834, respectively, in 2014.

Novel Products:

M402 Phase 1/2 study amended to add Abraxane(R)

Momenta has amended its Phase 1/2 proof-of-concept study to add the chemotherapy agent Abraxane(R) (nab-paclitaxel) into the protocol as part of the standard of care regimen to be administered in combination with Gemzar(R) (gemcitabine). Momenta made this change to the protocol because, in consultation with clinical key opinion leaders and other experts, it is clear that standard of care is evolving towards the Abraxane/gemcitabine combination as first line therapy for metastatic pancreatic cancer. The overall design of the current study will not change with the addition of Abraxane to the standard of care treatment.
The primary objectives of Part A are to evaluate safety and tolerability of M402 in combination with Abraxane and gemcitabine and to establish the dose of M402 to take forward into Part B. Part B will be a randomized, controlled study to evaluate the antitumor activity of M402 in combination with Abraxane plus gemcitabine, versus Abraxane plus gemcitabine alone. As a result of the amendment and the lead time required to implement the protocol changes, Momenta now expects to have data from Part A during the first half of 2014.

"We are pleased to be amending the M402 study to include Abraxane based on its promising Phase 3 clinical results," said Jim Roach, M.D., Chief Medical Officer and Senior Vice President, Development at Momenta. "Our investigators are enthusiastic to be evaluating patients with this new treatment regimen in combination with M402."

Sialylation research program

Momenta continues to make significant progress investigating the biology of sialylated IVIG to inform the company's selection of the best indication to consider taking forward into its first clinical programs, as well as defining the specific product to advance to the clinic.

First Quarter 2013 Financial Results

Total revenue for the first quarter of 2013 was $7.6 million (including product revenue of $5.4 million), compared to $24.2 million (including product revenue of $22.0 million) for the same period in 2012. The decrease in product revenue of $16.6 million was principally due to a change in the contractual basis of Momenta's earned enoxaparin product revenues following the January 2012 launch of a competitor's generic Lovenox(R) as well as decreased unit sales due to lower market share, and lower prices in response to competitor pricing reductions on enoxaparin. Sandoz reported first quarter enoxaparin net sales of $47 million, which was down from $176 million for the first quarter 2012 due to loss of enoxaparin exclusivity. Momenta first quarter 2013 revenues also include $2.2 million in research and development revenue, including $0.7 million in amortization of the $33 million payment received from the Baxter collaboration.

Research and development expenses, including stock-based compensation, for the first quarter of 2013 were $22.3 million, compared to $18.6 million, including stock-based compensation, for the same period in 2012. The increase was primarily due to research costs related to the company's biosimilars and novel products programs, clinical trial expenses, and increased headcount to support advancement of the company's pipeline of complex generics, biosimilars, and novel product candidates.

General and administrative expenses for the first quarter of 2013 were $9.7 million, including stock-based compensation, compared with $11.0 million, including stock-based compensation, for the same period in 2012. The decrease of $1.3 million from same period in 2012 was primarily due to a decrease of $0.7 million in professional fees principally due to decreased legal fees relating to Enoxaparin Sodium Injection patent litigation.

At March 31, 2013, Momenta had $324.2 million in cash, cash equivalents and marketable securities. This cash position excludes restricted cash of $17.5 million, which serves as collateral for a security bond related to enoxaparin legal proceedings, and $2.5 million related to a facility lease letter of credit.

Financial Guidance

Momenta confirmed its guidance for 2013 for total operating expenses, excluding stock compensation and net of collaborative revenues, averaging approximately $30 million per quarter. For 2013, Momenta is projecting that its net cash usage will average approximately $20 to $24 million per quarter for a total operating cash usage of approximately $80 to $90 million for 2013.‹