conference date: August 10, 2015 @ 1:30 PM Pacific Time
for quarter ending: June 30, 2015 (Q2, second quarter 2015)
Overview: Development stage company; revenue is from collaborations, so far.
Basic data (GAAP):
Revenue was $36.6 million, up sequentially from $14.8 million, and up from $27.8 million in the year-earlier quarter.
Net income was negative $22.9 million, up sequentially from negative $34.7 million, and down from negative $18.1 million year-earlier.
EPS was negative $0.21, up sequentially from negative $0.32 and down from negative $0.17 year-earlier.
The FDA accepted an application for MM-398 for metastatic pancreatic cancer and set a decision (PDUFA) date of October 24, 2015. The MM-398 program was expanded to imaging metastatic breast cancer. In the remainder of 2015 Merrimack hopes for the commercial launch of MM-398 and will initiate new clinical trials for it in front-line metastatic pancreatic cancer and front-line HER2-negative gastric cancer.
All revenue in the quarter was from collaboration with Baxter. It includes $20 million in non-recurring revenue from the Baxter milestone payment due on the European marketing application.
Merrimack is preparing for the commercial launch of MM-398 in the United States.
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 MM-141 Phase 2 clinical trial in 2015 for frontline pancreatic cancer who have high serum IGF-1 levels, in combination with existing therapies continues. MM-141 is believed to sensitize tumors to the nab-paclitaxel and gemcitabine combination. Only 146 biomarker positive patients will be enrolled.
A trial of MM-151 for EGFR-positive colorectal cancer should begin in 2015.
See also the Merrimack Pipeline.
Cash and equivalents ended at $67.7 million, down sequentially from $91.8 million, for a $24.1 million burn in the quarter. Lists $248.1 million in total liabilities. Filed a $40 million ATM (at-the-market) program to fund the MM-398 launch.
In July an $11 million milestone payment for PharmaEngine was paid.
Merrimack believes it has cash to fund operations into of 2016, assuming Baxter milestones are realized. Sales of MM-398, if approved by the FDA, would further extend the cash runway.
Operating expenses were $55.1 million, consisting of: $42.8 million for R&D; and $12.3 million for general and administrative expenses. Operating profit was negative $22.9 million. Other expenses (including non-cash imputed interest) were $0.1 million.
Gating factors for frontline pancreatic cancer for 398? We are working with Baxalta to get regulatory approval and enroll sites. We will update you shortly when the study is fully launched.
MM-121 timeline? We should have an update this fall. The U.S. sites are relatively easy to set up, the sites in other countries can take longer.
We had a positive conversation with Japanese regulatory authorities to our 302 sites. If we are able to add Japan to HERMIONE, that could accelerate the timeline for approval in Japan.
MM-398 price sensitivity and reimbursement? We can't talk about that until we have a label from the agency, but we believe there is a strong value proposition for MM-398.
EU approval timeline? Baxalta (Baxter) is leading the efforts in Europe. It works differently than in the U.S. The EU works on a 120 day review cycle basis, which can go on until the EMEA's questions are all addressed.
MM-121 potential collaborators? We are looking to secure funding to expand the indication into breast cancer and NSCLC. The process of finding a partner is going well, we have talked to a number of partners. But it can be a long process.
Analyst Conference Summaries Main Page
Merrimack Pharmaceuticals main Openicon page