Merrimack Reports Fourth Quarter and Full Year 2018 Financial Results
"Last quarter, we engaged external advisors and initiated a process to explore Merrimack's strategic alternatives. This is an active process that we are working expeditiously to bring to conclusion, with a range of potential outcomes under consideration. We are also committed to preserving the value of the potential milestones that Merrimack remains eligible to receive from
Program Update:
MM-310:
In
As of
If all three patients in the 360 mg every four weeks dose cohort successfully complete the observation period for dose-limiting toxicities, which is expected to occur in mid-March, Merrimack would plan to begin enrolling the next dose-escalation cohort at 420 mg of MM-310 every four weeks.
Preclinical Programs:
In
Six posters highlighting Merrimack's preclinical work have been accepted to the AACR Annual Meeting, to be held
1) A novel human TNFR2 antibody (MM-401) modulates T cell responses in anti-cancer immunity
Sunday, March 31, 2019 ;1:00 PM-5:00 PM - Exhibit Hall B, Poster Section 23, Poster Board #19
- Abstract #555
2) MM-401: Mechanism of action of a novel agonist TNFR2 antibody that induces co-stimulation of T cells and promotes robust anti-tumor immunity
Tuesday, April 2, 2019 ;8:00 AM-12:00 PM - Exhibit Hall B, Poster Section 25, Poster Board #20
- Abstract #3270
3) MM-401, a novel anti-TNFR2 antibody that induces T cell co-stimulation, robust anti-tumor activity and immune memory
Wednesday, April 3, 2019 ;8:00 AM-12:00 PM - Exhibit Hall B, Poster Section 15, Poster Board #4
- Abstract #4846
4) Development of a second-generation TRAIL agonist and predictive biomarker profile for colorectal cancer
Sunday, March 31, 2019 ;1:00 PM-5:00 PM - Exhibit Hall B, Poster Section 32, Poster Board #4
- Abstract #700
5) Engineering and preclinical activity of MM-201, a best-in-class TRAIL receptor agonist
Monday, April 1, 2019 ;1:00 PM-5:00 PM - Exhibit Hall B, Poster Section 32, Poster Board #1
- Abstract #2491
6) Targeting DNA-damage response pathway with a novel nano-liposomal ATR inhibitor in solid tumors
Sunday, March 31, 2019 ;1:00 PM-5:00 PM - Exhibit Hall B, Poster Section 1, Poster Board #8
- Abstract #8
Fourth Quarter and Full Year 2018 Financial Results
In
In
The following summarizes Merrimack's financial results for the three months and year ended
- Research and development expenses for the three months ended
December 31, 2018 were$10.2 million , compared to$12.4 million for the three months endedDecember 31, 2017 . Research and development expenses for the year endedDecember 31, 2018 were$50.0 million , compared to$67.3 million for the year endedDecember 31, 2017 . Research and development spending for the three months and year endedDecember 31, 2018 included$1.0 million related to theNovember 2018 restructuring and reflected reduced expenditures over comparable periods in 2017. The decrease was primarily due to phasing and close out of certain clinical development programs - General and administrative expenses for the three months ended
December 31, 2018 were$4.0 million , compared to$4.7 million for the three months endedDecember 31, 2017 . General and administrative expenses for the year endedDecember 31, 2018 were$15.6 million , compared to$28.5 million for the year endedDecember 31, 2017 . General and administrative spending for the three months and year endedDecember 31, 2018 included$0.3 million related to theNovember 2018 restructuring and was less than expenditures over comparable periods in 2017, primarily due to a decrease in corporate expenses related to reduced headcount levels and stock-based compensation; - Net loss attributable to Merrimack's continuing operations for the three months ended
December 31, 2018 was$12.9 million , or$0.97 per share, compared to a net loss attributable to Merrimack's continuing operations of$11.8 million , or$0.89 per share, for the three months endedDecember 31, 2017 . Net loss for the year endedDecember 31, 2018 was$60.8 million , or$4.55 per share, compared to a net loss attributable to Merrimack's continuing operations of$74.8 million , or$5.66 per share, for the year endedDecember 31, 2017 ; and - As of
December 31, 2018 , Merrimack had 13.3 million shares of common stock,$0.01 par value per share, outstanding.
Financial Outlook
Merrimack believes that its cash, cash equivalents and marketable securities of $71.3 million as of December 31, 2018, excluding any potential milestone payments, together with possible restructuring and cost cutting measures that Merrimack could implement in the future, provide Merrimack with the potential to fund its operations into at least the second half of 2022.
Merrimack remains eligible to receive additional milestone payments from Servier and
- Merrimack is entitled to receive up to an additional
$5 million in milestones from Servier, which is excluded from Merrimack's cash runway guidance until achieved. This milestone is triggered byIpsen's and Servier's decision to progress their ongoing multi-part clinical trial evaluating ONIVYDE in SCLC into the second randomized portion of the study focused on efficacy; - Merrimack is also entitled to receive up to an aggregate of
$450 million in regulatory-based milestones fromIpsen , which Merrimack has said it expects to pass through to its stockholders, net of any taxes owed and subject to there being sufficient surplus at that time, consisting of: $225 million upon approval by theFDA of ONIVYDE for the first-line treatment of metastatic adenocarcinoma of the pancreas, subject to certain conditions;$150 million upon approval by theFDA of ONIVYDE for the treatment of SCLC after failure of first-line chemotherapy; and$75 million upon approval by theFDA of ONIVYDE for an additional indication unrelated to those described above.
About Merrimack
Merrimack is a biopharmaceutical company based in Cambridge, Massachusetts that is outthinking cancer to ensure that patients and their families live fulfilling lives. Its mission is to transform cancer care through the smart design and development of targeted solutions based on a deep understanding of cancer pathways and biological markers. All of Merrimack's development programs fit into its strategy of 1) understanding the biological problems it is trying to solve, 2) designing specific solutions and 3) developing those solutions for biomarker-selected patients. This three-pronged strategy seeks to ensure optimal patient outcomes. For more information, please visit Merrimack's website at www.merrimack.com.
Forward Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include any statements about Merrimack's strategy, future operations, future financial position, future revenues and future expectations and plans and prospects for Merrimack, and any other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue" and similar expressions. In this press release, Merrimack's forward-looking statements include, among others, statements about expectations regarding Merrimack's exploration of strategic alternatives and associated potential outcomes, cash runway, and the anticipated achievement, receipt and distribution of milestones. Such forward-looking statements involve substantial risks and uncertainties that could cause Merrimack's clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the availability of data from ongoing clinical trials, expectations for regulatory approvals, development progress of Merrimack's companion diagnostics, availability of funding sufficient for Merrimack's foreseeable and unforeseeable operating expenses and capital expenditure requirements, and other matters that could affect the availability or commercial potential of Merrimack's product candidates or companion diagnostics. Merrimack undertakes no obligation to update or revise any forward-looking statements. Forward-looking statements should not be relied upon as representing Merrimack's views as of any date subsequent to the date hereof. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Merrimack's business in general, see the "Risk Factors" section of Merrimack's Quarterly Report on Form 10-Q filed with the
Merrimack Pharmaceuticals, Inc. |
||||
Consolidated Statements of Operations and Comprehensive Loss |
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Years Ended December 31, |
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(in thousands, except per share amounts) |
2018 |
2017 |
||
Operating expenses: |
||||
Research and development expenses |
$ 49,974 |
$ 67,314 |
||
General and administrative expenses |
15,601 |
28,452 |
||
Total operating expenses |
65,575 |
95,766 |
||
Loss from continuing operations |
(65,575) |
(95,766) |
||
Other income and expenses: |
||||
Interest income |
1,299 |
895 |
||
Interest expense |
(956) |
(34,650) |
||
Gain on deconsolidation of Silver Creek Pharmaceuticals, Inc. |
— |
10,848 |
||
Gain on sale of asset |
— |
1,703 |
||
Other (expense) income, net |
(3,230) |
(1,433) |
||
Total other income and expenses |
(2,887) |
(22,637) |
||
Net loss from continuing operations before income tax benefit |
(68,462) |
(118,403) |
||
Income tax benefit |
7,695 |
42,399 |
||
Net loss from continuing operations |
(60,767) |
(76,004) |
||
Discontinued operations: |
||||
Income from discontinued operations, net of tax |
20,261 |
546,872 |
||
Net (loss) income |
(40,506) |
470,868 |
||
Net loss attributable to non-controlling interest |
— |
(1,160) |
||
Net (loss) income attributable to Merrimack Pharmaceuticals, Inc. |
$ (40,506) |
$ 472,028 |
||
Other comprehensive loss: |
||||
Unrealized loss on marketable securities |
(9) |
— |
||
Other comprehensive loss |
(9) |
— |
||
Comprehensive (loss) income |
$ (40,515) |
$ 472,028 |
||
Amounts attributable to Merrimack Pharmaceuticals, Inc.: |
||||
Net loss from continuing operations |
$ (60,767) |
$ (74,844) |
||
Income from discontinued operations, net of tax |
20,261 |
546,872 |
||
Net (loss) income attributable to Merrimack Pharmaceuticals, Inc. |
$ (40,506) |
$ 472,028 |
||
Basic and dilutive net (loss) income per common share |
||||
Net loss from continuing operations |
$ (4.55) |
$ (5.66) |
||
Net income from discontinued operations, net of tax |
1.52 |
41.33 |
||
Net (loss) income per share |
$ (3.03) |
$ 35.67 |
||
Weighted-average common shares used per share calculations—basic and diluted |
13,343 |
13,232 |
Merrimack Pharmaceuticals, Inc. |
||||
Selected Balance Sheet Data (unaudited) |
||||
(in thousands) |
December 31, |
December 31, |
||
Cash, cash equivalents and marketable securities |
$ 71,278 |
$ 93,441 |
||
Working capital |
61,307 |
75,269 |
||
Total assets |
88,543 |
117,326 |
||
Total liabilities |
29,724 |
21,042 |
||
Total stockholders' equity |
58,819 |
96,284 |
CONTACT:
212-362-1200
josh@sternir.com
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