On August 10, 2015Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK), a biopharmaceutical company discovering, developing and preparing to commercialize innovative medicines paired with companion diagnostics for the treatment of cancer, reported its second quarter 2015 financial results (Press release, Merrimack, AUG 10, 2015, View Source/releasedetail.cfm?ReleaseID=926918" target="_blank" title="View Source/releasedetail.cfm?ReleaseID=926918" rel="nofollow">View Source [SID:1234507162]). Merrimack will host a live conference call and webcast today, Monday, August 10 at 4:30 p.m., Eastern time, to provide an update on Merrimack’s progress as well as a summary of these results.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Investors and the general public are invited to listen to the call by dialing (877) 564-1301 (domestic) or (224) 357-2394 (international) five minutes prior to the start of the call and providing the passcode 97495685. A listen-only webcast of the call can be accessed in the Investors section of Merrimack’s website, View Source, and a replay of the call will be archived there for six weeks following the call.
Key Recent Events
Acceptance of New Drug Application (NDA) and receipt of Priority Review designation by the U.S. Food and Drug Administration (FDA) for MM-398 with a goal of October 24, 2015 as the action date for the NDA under the Prescription Drug User Fee Act (PDUFA date);
Expansion of MM-398 imaging study to metastatic breast cancer;
Addition, effective August 11, 2015, of Dr. Yasir Al-Wakeel as Chief Financial Officer and head of Corporate Development; and
Addition of John Dineen, former CEO of GE Healthcare, to its Board of Directors.
Upcoming Milestones
Merrimack anticipates the following milestones in 2015:
MM-398 NDA PDUFA date of October 24, 2015;
Commercial launch of MM-398, pending approval by the FDA;
Initiation of a clinical trial of MM-398 in front-line metastatic pancreatic cancer;
Initiation of a clinical trial of MM-398 in front-line HER2-negative gastric cancer;
Initiation of a clinical trial of MM-151 in EGFR-positive colorectal cancer;
Continued enrollment in HERMIONE, a Phase 2 clinical trial designed to support a potential Accelerated Approval application to the FDA for MM-302 in patients with HER2-positive metastatic breast cancer;
Continued enrollment in a Phase 2 clinical trial of MM-121 in patients with heregulin-positive, locally advanced or metastatic non-small cell lung cancer; and
Continued enrollment in a Phase 2 clinical trial of MM-141 in patients with front-line metastatic pancreatic cancer who have high serum levels of free IGF-1.
Second Quarter 2015 Financial Results
Revenue for the second quarter of 2015 was $36.6 million compared with revenue of $27.8 million for the second quarter of 2014, an increase of $8.7 million or 31%. This increase was attributable to $36.6 million of revenue recognized related to Merrimack’s collaboration with Baxalta during the second quarter of 2015, including $20.0 million of non-recurring revenue recognized related to a milestone that was achieved when the European Medicines Agency (EMA) accepted for review a Marketing Authorization Application (MAA) filed by Baxalta for MM-398. This increase was offset by $27.8 million of decreased revenue due to the termination of Merrimack’s collaboration with Sanofi effective December 17, 2014.
Research and development expenses increased $9.0 million over the corresponding quarter of the preceding year. This increase was primarily attributable to $10.6 million of increased MM-398 expenses, primarily due to costs associated with a non-recurring $11.0 million milestone event that was incurred in the second quarter of 2015 and paid in July 2015 related to the EMA accepting for review an MAA filed by Baxalta for MM-398.
General and administrative expenses increased $4.4 million over the corresponding quarter of the preceding year. This increase was primarily attributable to increased infrastructure and personnel expenses as Merrimack prepares for the potential commercialization of MM-398 and increased facility-related costs.
Merrimack’s net loss for the second quarter of 2015 was $22.9 million, or basic and diluted net loss per share available to common stockholders of $0.21, as compared to a net loss for the second quarter of 2014 of $18.3 million, or basic and diluted net loss per share available to common stockholders of $0.17.
Financial Outlook
Merrimack expects to be able to fund operations into 2016 through its unrestricted cash and cash equivalents and available-for-sale securities of $67.7 million as of June 30, 2015, anticipated cost sharing reimbursements from Baxalta and the anticipated receipt of $51.5 million of net milestones related to MM-398 from Baxalta in 2015, after offsetting payments to PharmaEngine. Any cash inflows from Merrimack’s at-the-market (ATM) offering program, business development, sales of MM-398, if it receives marketing approval, and any additional net milestones related to MM-398 that Merrimack receives from Baxalta in 2016, after offsetting milestone payments to PharmaEngine, would provide further funding for Merrimack’s operations.