conference date: May 7, 2015 @ 1:30 PM Pacific Time
for quarter ending: March 31, 2015 (Q1, first quarter 2015)
Overview: Development stage company; revenue is from collaborations, so far.
Basic data (GAAP):
Revenue was $14.8 million, down sequentially from $33.9 million, and up from $13.0 million in the year-earlier quarter.
Net income was negative $34.7 million, down sequentially from negative $9.7 million, and down from negative $27.6 million year-earlier.
EPS was negative $0.32, down sequentially from negative $0.09 and down from negative $0.27 year-earlier.
All $14.8 million of revenue in the quarter was from collaboration with Baxter.
HERMIONE Phase 2 trial for MM-302 for HER-2 positive breast cancer continued, in combination with herceptin. MM-121 trial in non-small cell lung cancer also continues to enroll. Seeing strong interest from potential partners in collaborating in MM-121 for breast cancer.
An NDA for MM-398 was submitted to the FDA by for second line metastatic pancreatic cancer; and Baxter made the filing to the EMA in Europe. The FDA had previously granted MM-398 fast track status for 2nd line metastatic adenocarcinoma of the pancreas. Could gain approval as early as Q4 2015. Has begun commercial planning.
The development of MM-398 for other indications continues.
Merrimack this week initiated an MM-141 Phase 2 clinical trial in 2015 for frontline pancreatic cancer, in combination with existing therapies, which last week was given orphan drugs status by the FDA. MM-141 is believed to sensatize tumors to the nab-paclitaxel and gemcitabine combination. Only 146 biomarket positive patients will be enrolled.
See also the Merrimack Pipeline.
Cash and equivalents ended at $91.8 million, down sequentially from $124.0 million, for a $32 million burn in the quarter. Lists $255.8 million in total liabilities.
Merrimack believes it has cash to fund operations into of 2016, assuming Baxter milestones are realized.
Operating expenses were $44.9 million, consisting of: $35.7 million for R&D; and $9.2 million for general and administrative expenses. Operating profit was negative $30.0 million. Other expenses (including non-cash imputed interest) were $4.4 million. Net loss was $34.4 million.
Initiation of frontline metastatic pancreatic cancer timeline? We are working on logistics and investigor buy in. We hope to be able to provide timing and details of the study in the near future.
Disclosure of other indications by Baxter? Not another indication, but nations outside Europe.
AACR GI tolerability issues? We are not aware of any issues regarding GI tolerability from the investigators.
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