Enters 2013 With Six Novel Therapeutic Candidates in Clinical Development, Including Phase 3 and Phase 2 Trials in Multiple Cancer Indications
Progress Made in 2012 Puts Merrimack in Position for Robust Set of Milestones in 2013
CAMBRIDGE, Mass., March 14, 2013 (GLOBE NEWSWIRE) -- Merrimack Pharmaceuticals, Inc. (Nasdaq:MACK), a biopharmaceutical company discovering, developing and preparing to commercialize innovative medicines paired with companion diagnostics for the treatment of cancer, today announced its fourth quarter and full year 2012 financial results."We continue to make steady progress in advancing our therapeutic and diagnostic candidates toward our ambition to provide new regimens for patients to dramatically improve cancer outcomes," said Robert Mulroy, President and CEO of Merrimack. "We are encouraged by the medical community's strong support as we enroll clinical studies across multiple indications and remain on track to announce top line results from a number of these trials in 2013." Merrimack will host a conference call today, Thursday, March 14 at 10 a.m., Eastern time, to provide a brief update on its development pipeline, focusing on MM-398, Merrimack's nanotherapeutic encapsulation of irinotecan, and MM-121, Merrimack's ErbB3 (HER3) inhibitor. The call will also provide a summary of fourth quarter and full year 2012 financial results. 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 1577 7363. Slides accompanying the call and a listen-only webcast of the call can be accessed in the Investor Relations section of Merrimack's website, http://investors.merrimackpharma.com , and a replay of the call will be archived there. Key Recent Accomplishments, Upcoming Milestones and Conferences In the past few months, Merrimack achieved a number of significant accomplishments, including:
- Initiation of a Phase 1 study of MM-141, Merrimack's IGF-1R and ErbB3 pathway inhibitor;
- Initiation of a translational study of MM-398 to investigate potential predictive response markers in patients with advanced colorectal, lung and triple-negative breast cancers; and
- Presentation of Phase 1 monotherapy data of MM-302, Merrimack's HER2-targeted nanotherapeutic encapsulation of doxorubicin, in patients with HER2 positive breast cancer at the San Antonio Breast Cancer Symposium.
- Completion of enrollment and announcement of top line data on the NAPOLI-1 study, MM-398's global Phase 3 clinical trial in gemcitabine-resistant pancreatic cancer;
- Completion of enrollment and announcement of top line data from several MM-121 Phase 2 clinical trials in breast, ovarian and lung cancers;
- Initiation of a Phase 2 clinical trial for MM-111 in second line gastric cancer; and
- Initiation of multiple Phase 1 combination and translational studies.
- American Association for Cancer Research, April 6-10, 2013 in Washington, D.C.; and
- Bank of America Merrill Lynch 2013 Healthcare Conference, May 14-16, 2013 in Las Vegas, Nevada.
- Net loss for 2012 was $91.8 million, or basic and diluted net loss per share available to common stockholders of $(1.28), compared with net loss for 2011 of $79.7 million, or basic and diluted net loss per share available to common stockholders of $(7.67). This decrease in net loss per share available to common stockholders was primarily attributable to an increase in the weighted-average common shares used in computing net loss per share available to common stockholders as a result of Merrimack's April 2012 initial public offering in which all outstanding shares of Merrimack's convertible preferred stock were converted into 66,255,529 shares of common stock and in which Merrimack issued 15,042,459 new shares of common stock.
- Collaboration revenues for 2012 were $48.9 million, compared to $34.2 million for 2011, an increase of $14.7 million, or 43%. This increase was a result of increases in development, milestone and manufacturing revenues recognized under the 2009 license and collaboration agreement with Sanofi for the development and commercialization of MM-121.
- Research and development expenses for 2012 were $125.9 million, compared to $100.6 million for 2011, an increase of $25.3 million, or 25%. This increase was primarily attributable to the following:
- $7.0 million of increased spending on preclinical programs, general research and discovery due to an increase in the number of preclinical programs in the pipeline, increased costs associated with each preclinical program as these programs approach clinical development and the timing of manufacturing activities;
- $6.1 million of increased spending on the MM-141 program related to IND-enabling activities and initiation of a Phase 1 clinical trial that occurred during 2012;
- $4.8 million of increased spending on the MM-121 program primarily related to increased enrollment and costs associated with clinical trials;
- $4.2 million of increased spending on the MM-111 program primarily due to costs associated with preparing to initiate Merrimack's planned Phase 2 clinical trial and costs associated with ongoing clinical trials; and
- $3.3 million of increased overall spending on the MM-398 program primarily related to Merrimack's ongoing Phase 3 clinical trial, partially offset by the absence of a $10.0 million license payment made during 2011 that did not recur in 2012.
- General and administrative expenses for 2012 were $15.8 million, compared to $14.5 million for 2011, an increase of $1.3 million, or 9%. This increase was primarily related to an increase in labor and labor-related costs, and increased rent, insurance and pre-commercialization costs, partially offset by decreased depreciation expense.
- On November 8, 2012, Merrimack entered into a Loan and Security Agreement with Hercules Technology Growth Capital, Inc. (NYSE:HTGC) pursuant to which Merrimack received loans in the aggregate principal amount of $40.0 million. The Loan and Security Agreement provided for an initial term loan advance of $25.0 million, which closed on November 8, 2012, and an additional term loan advance of $15.0 million, which closed on December 14, 2012. The term loans bear interest at an annual rate equal to the greater of 10.55% and 10.55% plus the prime rate of interest minus 5.25%, but may not exceed 12.55%. Merrimack received net proceeds of $39.7 million from the term loans during the fourth quarter of 2012.