PR Newswire
CAMBRIDGE, Mass., Nov. 9, 2016
CAMBRIDGE, Mass., Nov. 9, 2016 /PRNewswire/ -- Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) today announced its third quarter 2016 financial results. Merrimack will host a live conference call and webcast today, Wednesday, November 9 at 4:30 p.m., Eastern time, to provide an update on Merrimack's progress as well as a summary of these 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 89606889. 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.
ONIVYDE® (irinotecan liposome injection) Update
ONIVYDE updates include:
Key Recent Events
Merrimack's key recent events include:
Third Quarter 2016 Financial Results
The following summarizes Merrimack's financial results from the quarter ended September 30, 2016:
Financial Outlook
In an effort to provide further insight into the expected timing of upcoming research and development and regulatory milestones, Merrimack provides the following schedule:
Milestone Trigger | | Cash Inflows from Shire plc (in millions) | | | Cash Outflows to PharmaEngine, Inc. (in millions) | | | Expected Timing | | Milestone Accounting Treatment | ||
Sale1 of ONIVYDE in first major European country | | $ | 30.0 | | | $ | 25.5 | | | Q4 2016 | | Substantive |
Sale1 of ONIVYDE in two additional major European countries | | | 30.0 | | | | 3.0 | | | First half of 2017 | | Substantive |
First patient dosed in small cell lung cancer trial | | | 10.0 | | | | — | | | First half of 2017 | | Non-Substantive |
Sale1 of ONIVYDE in first major non-European, non-Asian country | | | 5.0 | | | | — | | | First half of 2017 | | Substantive |
Sale1 of ONIVYDE in first Asian country | | | 25.0 | | | | 25.0 | | | Second half of 2017 | | Substantive |
Total expected cash flows from upcoming milestones | | $ | 100.0 | | | $ | 53.5 | | | | | |
1 Sale means the earlier of first commercial sale or receipt of pricing/reimbursement approval.
With respect to its fiscal 2016 guidance, Merrimack:
With respect to its fiscal 2017 guidance:
A table reconciling guidance for aggregate research and development and selling, general and administrative expenses, excluding anticipated milestone obligations to PharmaEngine, a non-GAAP financial measure, to aggregate research and development and selling, general and administrative expenses calculated in accordance with GAAP is included at the end of this press release.
About Merrimack
Merrimack is a fully integrated biopharmaceutical company that views cancer as a complex engineering challenge. Through systems biology, which brings together the fields of biology, computing and engineering, Merrimack aims to decrease uncertainty in drug development and clinical validation, and move discovery efforts beyond trial and error. Such an approach has the potential to make individualized treatment of patients a reality. Merrimack's first commercial product, ONIVYDE® (irinotecan liposome injection), was approved by the U.S. FDA in October 2015. With four additional candidates in clinical studies, several in preclinical development and multiple biomarkers designed to support patient selection, Merrimack is building one of the most robust oncology pipelines in the industry. For more information, please visit Merrimack's website at www.merrimack.com or connect on Twitter at @MerrimackPharma.
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 expectations regarding the outcome and effect of its ongoing strategic review of its product candidates, expected achievement of milestones, 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 future sales of products, 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 products, 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 Securities and Exchange Commission (SEC) on August 4, 2016 and other reports Merrimack files with the SEC.
Merrimack Pharmaceuticals, Inc. | | |||||||
Condensed Consolidated Statements of Operations and | | |||||||
Comprehensive Loss (unaudited) | | |||||||
| | | | |||||
| | Three Months Ended | | |||||
(in thousands, except per share amounts) | | September 30, 2016 | | | June 30, 2016 | | ||
Revenues: | | | | | | | | |
Product revenues, net | | $ | 14,493 | | | $ | 12,851 | |
License and collaboration revenues | | | 12,417 | | | | 19,332 | |
Other revenues | | | 1,161 | | | | 1,498 | |
Total revenues | | | 28,071 | | | | 33,681 | |
Costs and expenses: | | | | | | | | |
Cost of revenues | | | 1,010 | | | | 1,872 | |
Research and development expenses | | | 32,078 | | | | 40,996 | |
Selling, general and administrative expenses | | | 18,048 Werbung Mehr Nachrichten zur Merrimack Pharmaceuticals Inc Aktie kostenlos abonnieren
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