Merrimack Reports First Quarter 2017 Financial Results
"The first quarter of 2017 was transformative for Merrimack. Following our pipeline prioritization and the strategic review of our business, we emerged with clear priorities as a refocused research and clinical development company. We outlined three programs - MM-121, MM-141 and MM-310 - as the most promising clinical programs on which we will focus our development efforts going forward," said
First Quarter and Recent Highlights
In
- Prioritization of three clinical programs: MM-121 (seribantumab) targeting heregulin positive non-small cell lung cancer and heregulin positive, hormone receptor positive, HER2 negative metastatic breast cancer; MM-141 (istiratumab) targeting high IGF1 expression in metastatic pancreatic cancer patients; and MM-310, the antibody-directed nanotherapeutic (ADN) containing a prodrug of docetaxel for solid tumors;
- Initiation of a Phase 1 clinical study to assess safety, pharmacology and preliminary activity of MM-310 in solid tumors. Merrimack expects to report safety data and a recommended Phase 2 dose from this study in 2018;
- Closing of the sale of ONIVYDE and Merrimack's generic version of doxorubicin hydrochloride liposome injection to Ipsen S.A. for
$575 million in cash upon closing and up to$450 million in additional regulatory approval-based milestone payments. Merrimack also retained the right to receive net milestone payments of up to$33 million that may become payable pursuant to its previous license and collaboration agreement with Shire plc for the ex-U.S. development and commercialization of ONIVYDE; - Authorization by the Board of Directors of a special cash dividend of
$140 million to holders of Merrimack's common stock, which is payable onMay 26, 2017 from the proceeds of the asset sale to Ipsen; and - Appointment of
Daryl Drummond , Ph.D. as Head of Research.
Upcoming Milestones
Merrimack anticipates the following upcoming clinical milestones:
- Initiation this year of a Phase 2 randomized clinical study of MM-121 in patients with heregulin positive, hormone receptor positive, HER2 negative metastatic breast cancer;
- Top-line results in 2018 from the Phase 2 randomized clinical study of MM-121 in patients with heregulin positive non-small cell lung cancer;
- Top-line results in 2018 from the Phase 2 randomized clinical study of MM-141 in patients with front-line metastatic pancreatic cancer who have high serum levels of free IGF-1; and
- Safety data and the recommended Phase 2 dose in 2018 from the Phase 1 clinical study of MM-310 in patients with solid tumors.
First Quarter 2017 Financial Results
The following summarizes Merrimack's financial results for the three months ended
- In connection with the completion of the sale of ONIVYDE and Merrimack's generic version of doxorubicin hydrochloride liposome injection to Ipsen on
April 3, 2017 , the commercial business has been recorded in the financial statement within discontinued operations; - Research and development expenses were
$21.6 million for the three months endedMarch 31, 2017 , compared to$28.0 million for the three months endedMarch 31, 2016 , a decrease of$6.4 million , or 23%. This decrease was primarily attributable to the transition to the refocused clinical and preclinical pipeline; - General and administrative expenses were
$5.6 million for the three months endedMarch 31, 2017 , compared to$6.5 million for the three months endedMarch 31, 2016 , a decrease of$0.9 million , or 14%. This decrease was primarily attributable to lower headcount related to the restructuring activities that occurred in the fourth quarter of 2016; and - Net loss attributable to Merrimack for the three months ended
March 31, 2017 , was$29.7 million , or$0.23 per share, compared to a net loss attributable to Merrimack of$38.5 million , or$0.33 per share, for the three months endedMarch 31, 2016 .
FY 2017 Updated Financial Outlook
On
Special Cash Dividend to Stockholders
The special cash dividend of
Conference Call and Webcast
Merrimack will host a live conference call and webcast today,
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 14613459. A listen-only webcast of the call can be accessed in the Investors section of Merrimack's website, investors.merrimack.com, and a replay of the call will be archived there for six weeks following the call.
About Merrimack
Merrimack is a biopharmaceutical company based in
Cautionary Note on 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 the expected achievement of milestones,
the timing of availability of clinical trial data, potential cash inflows and outflows, revenue and expenses and the availability of funding sufficient to fund Merrimack's operations. 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 initiation of future clinical trials, 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 Annual Report on Form 10-K filed with the
| ||||||||||
Consolidated Statements of Operations and | ||||||||||
Comprehensive Loss Data (unaudited) | ||||||||||
Three Months Ended |
||||||||||
(in thousands, except per share amounts) |
2017(1) |
2016(1) |
||||||||
Costs and expenses: |
||||||||||
Research and development expenses |
$ 21,605 |
$ 28,002 | ||||||||
General and administrative expenses |
5,634 |
6,452 | ||||||||
Total costs and expenses |
27,239 |
34,454 | ||||||||
Loss from operations |
(27,239) |
(34,454) | ||||||||
Other income and expenses: |
||||||||||
Interest income |
14 |
72 | ||||||||
Interest expense |
(1,979) |
(3,290) | ||||||||
Other expense, net |
(2) |
(43) | ||||||||
Loss from continuing operations before income tax benefit |
(29,206) |
(37,715) | ||||||||
Income tax benefit |
— |
— | ||||||||
Loss from continuing operations |
(29,206) |
(37,715) | ||||||||
Loss from discontinued operations |
(947) |
(943) | ||||||||
Net loss |
(30,153) |
(38,658) | ||||||||
Net loss attributable to non-controlling interest |
(467) |
(185) | ||||||||
Net loss attributable to |
$ (29,686) |
$ (38,473) | ||||||||
Other comprehensive loss: |
||||||||||
Unrealized loss on available-for-sale securities |
— |
(14) | ||||||||
Other comprehensive loss |
— |
(14) | ||||||||
Comprehensive loss |
$ (29,686) |
$ (38,487) | ||||||||
Amounts attributable to |
||||||||||
Loss from continuing operations |
$ (28,739) |
$ (37,530) | ||||||||
Loss from discontinued operations |
(947) |
(943) | ||||||||
Net loss attributable to |
$ (29,686) |
$ (38,473) | ||||||||
Loss per share available to common stockholders—basic and |
||||||||||
Continuing operations |
$ (0.22) |
$ (0.32) | ||||||||
Discontinued operations |
(0.01) |
(0.01) | ||||||||
Net loss |
$ (0.23) |
$ (0.33) | ||||||||
Weighted-average common shares used per share calculations—basic and |
130,588 |
116,064 |
||||||||
(1) |
The amounts included in the loss from discontinued operations are in accordance with ASC 205, Presentation of Financial Statements, and do not include an allocation of fixed overhead costs. |
| |||||||||||||
Selected Balance Sheet Data (unaudited) | |||||||||||||
March 31, |
|
||||||||||||
(in thousands) |
2017(1) |
2016(1) |
|||||||||||
Cash and cash equivalents |
$ |
17,155 |
$ |
21,524 |
|||||||||
Working capital |
(61,312) |
(30,787) |
|||||||||||
Total assets |
68,639 |
81,483 |
|||||||||||
Total liabilities |
345,383 |
334,142 |
|||||||||||
Total stockholders' deficit |
(275,738) |
(251,120) |
|||||||||||
(1) The amounts in the above include assets and liabilities held for sale. |
| |||||||||
Selected Cash Flow Data (unaudited) | |||||||||
Years Ended |
|||||||||
(in thousands) |
2017(1) |
2016(1) |
|||||||
Net cash used in operating activities |
$ |
(10,156) |
$ |
(53,523) |
|||||
Net cash used in investing activities |
(290) |
(85,491) |
|||||||
Net cash provided by financing activities |
6,077 |
1,645 |
|||||||
Net decrease in cash and cash equivalents |
$ |
(4,369) |
$ |
(137,369) |
|||||
(1) The amounts in the above include cash flow from discontinued operations. |
CONTACT:
617-441-7602
ggrande@merrimack.com
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