Merrimack
MERRIMACK PHARMACEUTICALS INC (Form: 8-K, Received: 08/09/2017 07:40:45)

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 9, 2017

 

 

Merrimack Pharmaceuticals, Inc.

(Exact Name of Registrant as Specified in its Charter)

 

 

 

Delaware   001-35409   04-3210530

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

One Kendall Square, Suite B7201

Cambridge, MA

  02139
(Address of Principal Executive Offices)   (Zip Code)

Registrant’s telephone number, including area code: (617) 441-1000

(Former Name or Former Address, if Changed Since Last Report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions ( see General Instruction A.2. below):

 

  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR 230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR 240.12b-2).

Emerging growth company  ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐

 

 

 


Item 2.02. Results of Operations and Financial Condition.

On August 9, 2017, Merrimack Pharmaceuticals, Inc. announced its financial results for the quarter ended June 30, 2017. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information in this Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits

The following exhibit relating to Item 2.02 shall be deemed to be furnished, and not filed:

 

99.1    Press release issued by the Registrant on August 9, 2017


SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

        MERRIMACK PHARMACEUTICALS, INC.
Date: August 9, 2017     By:  

/s/ Jeffrey A. Munsie

     

  Jeffrey A. Munsie

  General Counsel


EXHIBIT INDEX

 

Exhibit No.

  

Description

99.1    Press release issued by the Registrant on August 9, 2017

Exhibit 99.1

Merrimack Reports Second Quarter 2017 Financial Results

– Announced hiring of industry veterans Dr. Sergio Santillana as Chief Medical Officer and Thomas Needham as

Chief Business Officer to bolster executive team –

– Phase 2 CARRIE study of MM-141 completed enrollment with data expected in first half of 2018 –

– Conference call at 8:30 am ET today –

Cambridge, Massachusetts, August 9, 2017 — Merrimack Pharmaceuticals, Inc. (NASDAQ: MACK) today announced its second quarter 2017 financial results for the period ended June 30, 2017.

“This quarter’s progress, with key hires to the executive team and advancements in the clinic, has reinforced Merrimack’s refined corporate and clinical strategy. With a rich, biomarker-driven R&D pipeline, including data expected in 2018 for each of our lead assets – MM-121, MM-141 and MM-310 – and promising preclinical programs, we are well positioned to execute on our goals,” said Richard Peters, M.D., Ph.D., President and Chief Executive Officer.

Second Quarter and Recent Highlights

Key events from the second quarter and more recently include:

 

    Expansion of Merrimack’s executive team with key appointments:

 

    Dr. Sergio Santillana, a medical oncologist and former Chief Medical Officer at Ariad Pharmaceuticals with extensive industry experience leading a wide range of clinical development programs, as Chief Medical Officer;

 

    Ellen Forest, an experienced human resources executive and former Director of Human Resources at Baxalta, as Head of Human Resources; and

 

    Thomas Needham, a 25-year industry veteran, experienced dealmaker and former Senior Vice President of Business Development at C4 Therapeutics, as Chief Business Officer.

 

    Completion of enrollment in the Phase 2 randomized, double-blind, placebo-controlled CARRIE study of MM-141 in combination with standard of care in previously untreated patients with metastatic pancreatic cancer who have high serum levels of free IGF-1. MM-141 is an inhibitor of the PI3K/AKT/mTOR signaling pathway, targeting the IGF-1 and HER3 receptors. Merrimack expects to report data in the first half of 2018.

Upcoming Milestones

Merrimack anticipates the following upcoming clinical milestones:

 

    Initiation this year of the SHERBOC trial, a Phase 2 randomized, double-blind, placebo-controlled clinical study of MM-121 added to standard of care in patients with heregulin positive, hormone receptor positive, HER2 negative metastatic breast cancer;

 

    Top-line results in the first half of 2018 from the Phase 2 randomized, double-blind, placebo-controlled CARRIE study of MM-141 in combination with standard of care in previously untreated patients with metastatic pancreatic cancer who have high serum levels of free IGF-1;

 

    Top-line results in the second half of 2018 from the Phase 2 randomized SHERLOC study of MM-121 added to standard of care in patients with heregulin positive non-small cell lung cancer; and

 

    Safety data and the recommended Phase 2 dose in the second half of 2018 from the Phase 1 clinical study of MM-310 in patients with solid tumors.


Second Quarter 2017 Financial Results

The following summarizes Merrimack’s financial results for the three months ended June 30, 2017:

 

    In April, Merrimack received a $575.0 million upfront cash payment from Ipsen in connection with its asset sale, from which Merrimack fully paid off $175.0 million of outstanding Senior Secured Notes due in 2022; paid a special cash dividend of $140.0 million to stockholders in May; and invested approximately $125.0 million into the further development of its streamlined oncology pipeline;

 

    Research and development expenses from continuing operations for the three months ended June 30, 2017 were $19.8 million, compared to $27.7 million for the three months ended June 30, 2016. This represents a decrease of $7.9 million primarily due to Merrimack’s transition to a refocused clinical and preclinical pipeline and offset by a one-time charge related to stock-based compensation;

 

    General and administrative expenses from continuing operations for the three months ended June 30, 2017 were $14.8 million, compared to $8.1 million for the three months ended June 30, 2016. This represents an increase of $6.7 million, primarily due to costs associated with the transition following the asset sale, including legal expenses and stock-based compensation; and

 

    Net loss attributable to Merrimack’s continuing operations for the three months ended June 30, 2017 was $28.9 million, or $0.22 per share, compared to a net loss attributable to Merrimack’s continuing operations of $51.4 million, or $0.41 per share, for the three months ended June 30, 2016.

Financial Outlook

Merrimack continues to believe that its unrestricted cash and cash equivalents of $135.5 million as of June 30, 2017, together with the potential net milestone payments anticipated from Shire, will be sufficient to fund its planned operations into the second half of 2019.

Conference Call and Webcast

Merrimack will host a live conference call and webcast today, Wednesday, August 9, 2017 at 8:30 am ET, to provide an update on its operational progress and a summary of these 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 56140335. 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.

Upcoming Investor Conferences

Merrimack will attend the following investor conference:

 

    Robert W. Baird 2017 Global Healthcare Conference, September 7, 2017 in New York.

A live webcast of the presentation can be accessed by visiting the Investors section of Merrimack’s website at investors.merrimack.com. A replay of the webcast will be archived there for two weeks following the presentation.

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 product candidates, including three in clinical studies and several others in preclinical development, 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 the timing of availability of clinical trial data, the initiation of new clinical trials, the anticipated achievement of milestones 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 Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on May 10, 2017 and the other reports Merrimack files with the SEC.


Merrimack Pharmaceuticals, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited)

 

     Three Months Ended
June 30,
    Six Months Ended
June 30,
 

(in thousands, except per share amounts)

   2017     2016     2017     2016  

Costs and expenses:

        

Research and development expenses

   $ 19,751     $ 27,695     $ 41,356     $ 55,697  

General and administrative expenses

     14,798       8,138       20,432       14,590  
  

 

 

   

 

 

   

 

 

   

 

 

 

Total costs and expenses

     34,549       35,833       61,788       70,287  
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from continuing operations

     (34,549     (35,833     (61,788     (70,287

Other income and expenses:

        

Interest income

     382       122       396       194  

Interest expense

     (26,762     (15,858     (28,741     (19,148

Gain on sale of asset

     1,703       —         1,703       —    

Other expense, net

     (659     (64     (661     (107
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss from continuing operations before income tax benefit

     (59,885     (51,633     (89,091     (89,348

Income tax benefit

     30,239       —         30,239       —    
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss from continuing operations

     (29,646     (51,633     (58,852     (89,348

Discontinued operations:

        

Income (loss) from discontinued operations, net of tax

     540,485       675       539,538       (268

Net income (loss)

     510,839       (50,958     480,686       (89,616

Net loss attributable to non-controlling interest

     (724     (208     (1,191     (393
  

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss) attributable to Merrimack Pharmaceuticals, Inc.

   $ 511,563     $ (50,750   $ 481,877     $ (89,223
  

 

 

   

 

 

   

 

 

   

 

 

 

Other comprehensive income (loss):

        

Unrealized gain on available-for-sale securities

     —         15       —         1  
  

 

 

   

 

 

   

 

 

   

 

 

 

Other comprehensive loss

     —         15       —         1  
  

 

 

   

 

 

   

 

 

   

 

 

 

Comprehensive income (loss)

   $ 511,563     $ (50,735   $ 481,877     $ (89,222
  

 

 

   

 

 

   

 

 

   

 

 

 

Amounts attributable to Merrimack Pharmaceuticals, Inc.:

        

Net loss from continuing operations

   $ (28,922   $ (51,425   $ (57,661   $ (88,955

Income (loss) from discontinued operations, net of tax

     540,485       675       539,538       (268
  

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss) attributable to Merrimack Pharmaceuticals, Inc.

   $ 511,563     $ (50,750   $ 481,877     $ (89,223
  

 

 

   

 

 

   

 

 

   

 

 

 

Basic and dilutive net income (loss) per common share

        

Net loss from continuing operations

   $ (0.22   $ (0.41   $ (0.44   $ (0.74

Net income (loss) from discontinued operations, net of tax

     4.08       0.01       4.10       (0.00
  

 

 

   

 

 

   

 

 

   

 

 

 

Net income (loss) per share

   $ 3.86     $ (0.40   $ 3.66     $ (0.74
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted-average common shares used per share calculations—basic and diluted

     132,457       126,161       131,528       121,112  

Cash dividend paid per common share

   $ 1.055     $ —       $ 1.055     $ —    


Merrimack Pharmaceuticals, Inc.

Selected Balance Sheet Data (unaudited)

 

     June 30,      December 31,  
(in thousands)    2017 (1)      2016 (1)  

Cash and cash equivalents

   $ 135,501      $ 21,524  

Working capital

     83,826        (30,787

Total assets

     213,450        81,483  

Total liabilities

     108,973        334,142  

Total stockholders’ equity / (deficit)

     106,508        (251,120

 

(1) The 2016 amounts in the above include assets and liabilities held for sale.

Merrimack Pharmaceuticals, Inc.

Selected Cash Flow Data (unaudited)

 

     Six Months Ended June 30,  
(in thousands)    2017 (1)      2016 (1)  

Net cash used in operating activities

   $ (95,510    $ (104,426

Net cash provided by (used in) investing activities

     515,809        (63,312

Net cash provided by (used in) financing activities

     (306,322      3,623  
  

 

 

    

 

 

 

Net increase (decrease) in cash and cash equivalents

   $ 113,977      $ (164,115
  

 

 

    

 

 

 

 

(1) The amounts in the above include cash flow from discontinued operations.

CONTACT:

Geoffrey M. Grande, CFA

617-441-7602

ggrande@merrimack.com