Foundation Medicine, Inc.
Foundation Medicine, Inc. (Form: 8-K, Received: 05/09/2017 16:08:11)

 

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): May 9, 2017

______________

Foundation Medicine, Inc.
(Exact name of registrant as specified in its charter)
______________

Delaware

 

001-36086

 

27-1316416

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(I.R.S. Employer

Identification No.)

150 Second Street

 

Cambridge, MA

02141

(Address of principal executive offices)

(Zip Code)


Registrant’s telephone number, including area code
(617) 418-2200

Not Applicable
(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:

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 or Rule 12b-2 of the Securities Exchange Act of 1934.

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 May 9, 2017, Foundation Medicine, Inc. issued a press release announcing its financial and operating results for the quarter ended March 31, 2017. A copy of the press release is being furnished as Exhibit 99.1 to this Report on Form 8-K.

The information in this Report on Form 8-K and Exhibit 99.1 attached hereto is intended to be furnished and 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 filing.

Item 9.01. Financial Statements and Exhibits.

     (d) Exhibits

Exhibit No.

Description

99.1 Press release issued by Foundation Medicine, Inc. dated May 9, 2017, furnished hereto.


SIGNATURES

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.

 

 

Date:

May 9, 2017

FOUNDATION MEDICINE, INC.

 

 

 

By:

/s/ Jason Ryan

Name:    Jason Ryan

Title:     Chief Financial Officer


EXHIBIT INDEX

Exhibit No.

Description

99.1 Press release issued by Foundation Medicine, Inc. dated May 9, 2017, furnished hereto.

Exhibit 99.1

Foundation Medicine Announces 2017 First Quarter Results and Recent Highlights

CAMBRIDGE, Mass.--(BUSINESS WIRE)--May 9, 2017--Foundation Medicine, Inc. (NASDAQ:FMI) today reported financial and operating results for its first quarter ended March 31, 2017. Results and business highlights for the quarter included:

“Foundation Medicine achieved several milestones this quarter that extend our leadership in molecular information, including strong growth in clinical volume, payment from Medicare and a collaboration with Bristol-Myers Squibb in the critical field of immuno-oncology,” said Troy Cox, chief executive officer of Foundation Medicine. “Importantly, we believe we are on track to achieve our 2017 business objectives, including advancing our universal companion diagnostic assay through the FDA and CMS parallel review process to a decision during the second half of this year.”

Foundation Medicine reported total revenue of $26.3 million in the first quarter of 2017, compared to $30.4 million in the first quarter of 2016. Total revenue declined year over year due to an expected decrease in first quarter biopharmaceutical revenue related to the timing of various research and development projects with its biopharma partners. Revenue from biopharmaceutical customers was $14.7 million in the first quarter of 2017 compared to $20.2 million in the first quarter of 2016. The results of 1,802 tests were reported to biopharmaceutical customers in this year’s first quarter.

Clinical revenue returned to year over year growth, partially driven by the receipt of Medicare payment for FoundationOne under Palmetto’s NSCLC LCD. Revenue from clinical testing in the first quarter of 2017 was $11.6 million, compared to $10.2 million in the first quarter of 2016.


The company reported 13,933 tests to clinicians in the first quarter of 2017, a 55% increase from the same quarter last year. This number includes 11,005 FoundationOne ® tests, 1,284 FoundationOne ® Heme tests, 1,355 FoundationACT ® tests, and 289 FoundationFocus CDx BRCA tests.

Total operating expenses for the first quarter of 2017 were approximately $55.0 million compared with $36.5 million for the first quarter of 2016. The increase in operating expenses was partially driven by investments related to the development of the company’s universal companion diagnostic assay. Net loss was approximately $46.5 million in the first quarter of 2017, or a $1.31 loss per share. At March 31, 2017, the company held approximately $99.1 million in cash, cash equivalents and marketable securities.

2017 Outlook

Foundation Medicine’s business and financial outlook for 2017 remains unchanged:

Conference Call and Webcast Details

The company will conduct a conference call today, Tuesday, May 9th at 4:30 p.m. Eastern Time to discuss its financial performance for the 2017 first quarter and other business activities, including matters related to future performance. To access the conference call via phone, dial 1-855-420-0652 from the United States and Canada, or dial 1-484-365-2939 internationally, and for either number reference Foundation Medicine and provide the passcode 10842512. Dial in approximately ten minutes prior to the start of the call. The live, listen-only webcast of the conference call may be accessed by visiting the investors section of the company’s website at investors.foundationmedicine.com. A replay of the webcast will be available shortly after the conclusion of the call and will be archived on the company's website for two weeks following the call.

About Foundation Medicine
Foundation Medicine (NASDAQ:FMI) is a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient’s unique cancer. The company offers a full suite of comprehensive genomic profiling assays to identify the molecular alterations in a patient’s cancer and match them with relevant targeted therapies, immunotherapies and clinical trials. Foundation Medicine’s molecular information platform aims to improve day-to-day care for patients by serving the needs of clinicians, academic researchers and drug developers to help advance the science of molecular medicine in cancer. For more information, please visit http://www.FoundationMedicine.com or follow Foundation Medicine on Twitter (@FoundationATCG).

Foundation Medicine ® , FoundationOne ® and FoundationACT ® are registered trademarks, and FoundationFocus and FoundationCORE are trademarks, of Foundation Medicine, Inc.


Cautionary Note Regarding Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the value of the company’s business; the benefits of our products to physicians, biopharmaceutical companies, payers and patients in the treatment of cancer and personalized cancer care; the company’s financial and operational forecasts, including projections regarding the generation of revenue, the number of tests to be conducted, the incurrence of operating expenses and the expansion of reimbursement progress; the benefits provided by a FDA-approved and CMS-covered version of FoundationOne and progress with the Parallel Review process with FDA and CMS; the scope and timing of any approval of our universal companion diagnostic assay as a medical device by the FDA and any coverage decision by CMS; and strategies for achieving Medicare coverage decisions at the local or national level and new and expanded coverage from third-party payers. All such forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include the risks that the FDA does not approve our universal companion diagnostic assay as a medical device or that CMS does not decide to offer our universal companion diagnostic assay as a covered benefit under Medicare; the FDA or CMS is delayed in the completion of the Parallel Review process; the company's new facilities in North Carolina and Germany do not facilitate the company's ability to achieve it business objectives; the company's distribution partner outside the United States is not able to achieve market penetration in new and existing markets as quickly or as extensively as projected; Foundation Medicine's relationships with third-party or government payers do not increase or expand; Foundation Medicine is unable to sustain or grow relationships with biopharmaceutical partners; the company's revenue, test or operating expense projections may turn out to be inaccurate because of the preliminary nature of the forecasts; the company's expectations and beliefs regarding the future conduct and growth of the company's business are inaccurate; Foundation Medicine is unable to achieve profitability, to compete successfully, to manage its growth, or to develop its molecular information platform; and the risks described under the caption “Risk Factors” in Foundation Medicine’s Annual Report on Form 10-K for the year ended December 31, 2016, which is on file with the Securities and Exchange Commission, as well as other risks detailed in Foundation Medicine’s subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Foundation Medicine undertakes no duty to update this information unless required by law.

- Financial Tables to Follow -


 

FOUNDATION MEDICINE, INC.
 Condensed Consolidated Statements of Operations

(In thousands, except share and per share data)
(unaudited)

 
Three Months Ended
March 31,
 

2017

   

2016

Revenue

$

26,328

$ 30,378
Costs and expenses:
Cost of revenue

 

18,017

11,390
Selling and marketing

 

16,436

13,793
General and administrative

 

15,277

9,224
Research and development

 

23,285

  13,456
 
Total costs and expenses

 

73,015

  47,863
 
Loss from operations

 

(46,687)

(17,485)
 
Interest income (expense), net

 

90

178
Other income

 

144

 
 
Net loss

$

(46,453)

$ (17,307 )
 
Net loss per common share applicable to common stockholders, basic and diluted

$

(1.31)

$ (0.50)
 
Weighted-average common shares outstanding, basic and diluted

 

35,426,296

  34,537,007

 

FOUNDATION MEDICINE, INC.
Condensed Consolidated Balance Sheets
(In thousands)
(unaudited)

 

         
March 31, December 31,
2017 2016
Assets
Current assets:
Cash and cash equivalents $ 49,075 $ 63,617
Marketable securities 49,976 79,402
Accounts receivable, net 10,728 10,213
Inventory 10,349 10,438
Prepaid expenses and other current assets   5,338   5,251
Total current assets 125,466 168,921
Property and equipment, net 39,553 41,486
Restricted cash 1,395 1,395
Other assets   2,140   2,233
Total assets $ 168,554 $ 214,035
 
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable $ 10,427 $ 11,898
Accrued expenses and other current liabilities 19,240 20,578
Deferred revenue 2,278 5,851
Current portion of deferred rent   2,418   2,324
Total current liabilities 34,363 40,651
Other non-current liabilities 7,874 8,538
Total stockholders’ equity   126,317   164,846
Total liabilities and stockholders’ equity $ 168,554 $ 214,035

CONTACT:
Foundation Medicine, Inc.
Media Contact:
Lee-Ann Murphy, 617-245-3077
pr@foundationmedicine.com
or
Investor Contact:
Kimberly Brown, 617-418-2215
ir@foundationmedicine.com