conference date: November 9, 2015 @ 1:30 PM Pacific Time
for quarter ending: September 30, 2015 (Q3, third quarter 2015)
Overview: First FDA approval after the quarter ended. Revenue in the quarter is from collaborations.
Basic data (GAAP):
Revenue was $16.4 million, down sequentially from $36.6 million, and down from $28.0 million in the year-earlier quarter.
Net income was negative $42.4 million, down sequentially from negative $22.9 million, and down from negative $27.9 million year-earlier.
EPS was negative $0.38, down sequentially from negative $0.21 and down from negative $0.27 year-earlier.
$47.5 million milestone payment from Baxalta is expected in Q4. There may also be cost sharing reimbursements from Baxalta.
The FDA approved ONIVYDE™ (irinotecan liposome injection) (formerly MM-398) for post-gemcitibine metastatic pancreatic cancer on October 22, 2015. The total addressable market for the current label is believed to be $800 million per year. The response from the oncology community has been quick and positive. In the remainder of 2015 Merrimack will continue the commercial launch of Onivyde.
The MM-398 program was expanded to imaging metastatic breast cancer. After the quarter ended a Phase 2 clinical trial of ONIVYDE for front-line metastatic pancreatic cancer enrolled its first patient. A total of 5 cancer types will be targeted by Baxalta and Merrimack with Onivyde in the next round of trials.
HERMIONE Phase 2 trial for MM-302 for third line HER-2 positive breast cancer continued, in combination with herceptin. Enrollment should complete in 2016 with data in 2017.
MM-121 trial in non-small cell lung cancer also continues to enroll. Data should report in the second half of 2016. 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. Results could be available in 2017.
See also the Merrimack Pipeline.
Cash and equivalents ended at $62.4 million, down sequentially from $67.7 million, for a $5.3 million burn in the quarter. Lists $243.3 million in total liabilities. Raised $38 million with ATM (at-the-market) program to fund the MM-398 launch. Cash used in operations was $42.3 million.
In July an $11 million milestone payment for PharmaEngine was paid.
Merrimack believes it has cash to fund operations into 2016, assuming Baxalta milestones are realized. Sales of MM-398 would further extend the cash runway. In 2016 $46.5 million Baxalta milestone payments should come in, further extending the runway.
Operating expenses were $54.7 million, consisting of: $37.8 million for R&D; and $17.0 million for general and administrative expenses. Operating profit was negative $38.3 million. Other expenses were $4.1 million.
Initiating 151, did that drop? EGFR inhibitor for colorectal cancer. We had good Phase 1 results. We are still working on the trial design and launch the study in the "not too distant future."
MM121 breast cancer and additional indications vs. competitive landscape? We got the drug back from Sanofi, we feel the competitive pressure is in lung cancer. We are monitoring the breast cancer competition. We are having active conversations about moving it forward with a partner.
Onivyde reimbursement? We are in early days on the reimbursement process. It may take a number of months to get agreements with all the payers. We are comfortable with our pricing.
Colorectal cancer trial for 151? We are in planning stages, we will provide details when the study is ready to go.
Analyst Conference Summaries Main Page
Merrimack Pharmaceuticals main Openicon page