mardi 22 septembre 2020


Foundation Medicine Announces 2017 Third Quarter Results and Recent Highlights

Par Rédaction , dans Communiqués , le 15 novembre 2017

Wednesday, November 1st 2017 at 8:01pm UTC

CAMBRIDGE, Mass.–(BUSINESS WIRE)– Foundation
Medicine, Inc.
(NASDAQ: FMI) today reported financial and operating
results for its third quarter ended September 30, 2017. Results and
business highlights for the quarter included:

  • Achieved third quarter revenue of $42.7 million, 45% year-over-year
    growth;
  • Reported 17,474 clinical tests in the third quarter, 50%
    year-over-year growth;
  • Presented validation data for FoundationOne CDx™ at the World
    Conference on Lung Cancer which demonstrated high concordance with
    multiple FDA-approved companion diagnostics across multiple solid
    tumor cancer types. FoundationOne CDx is currently under the Parallel
    Review process with FDA and CMS;
  • Presented validation data for a novel assay measuring tumor mutational
    burden in blood (bTMB) at the European Society for Medical Oncology
    (ESMO) providing evidence that response to immunotherapy can be
    predicted using a blood sample. Based on these findings, the bTMB
    assay is being integrated as part of Roche/Genentech’s prospective,
    randomized Phase III Blood First Assay Screening Trial (BFAST) as a
    companion diagnostic assay to investigate bTMB as a non-invasive
    biomarker of response to first-line atezolizumab in advanced NSCLC
    patients; and
  • Published 19 manuscripts in high-quality, peer-reviewed journals and
    delivered 21 podium and poster talks at various medical and scientific
    meetings.

“Foundation Medicine made great progress in the third quarter as
evidenced by record revenue and clinical volume,” said Troy Cox, chief
executive officer of Foundation Medicine. “Our recent accomplishments,
including progress with the parallel review process with FDA and CMS for
FoundationOne CDx, expanding relationships with our biopharma partners,
and driving continued innovation in our molecular information solutions
pipeline with bTMB, continue to position our company for further growth,
and competitive differentiation to transform cancer care.”

Foundation Medicine reported total revenue of $42.7 million in the third
quarter of 2017, compared to $29.4 million in the third quarter of 2016.
Revenue from biopharmaceutical customers was $29.6 million in the third
quarter of 2017, compared to $20.7 million in the third quarter of 2016.
The results of 2,817 tests were reported to biopharmaceutical customers
in this year’s third quarter.

Revenue from clinical testing in the third quarter of 2017 was $13.1
million, compared to $8.7 million in the third quarter of 2016. The
company reported 17,474 tests to clinicians in the third quarter of
2017, a 50% increase from the same quarter last year. This number
includes 14,398 FoundationOne® tests, 1,478 FoundationOne®
Heme tests, 1,488 FoundationACT® tests, and 110
FoundationFocus CDxBRCA tests.

Total operating expenses for the third quarter of 2017 were
approximately $56.0 million, compared with $44.9 million for the third
quarter of 2016. The increase in operating expenses was partially driven
by investments in product development such as FoundationOne CDx and
bTMB, investments in the company’s technology infrastructure, and
certain non-recurring cash and non-cash expenses.

Net loss was approximately $32.6 million in the third quarter of 2017,
or a $0.90 loss per share. At September 30, 2017, the company held
approximately $76.8 million in cash, cash equivalents and marketable
securities.

Based on the new revenue reporting the company initiated last quarter,
Molecular Information Services revenue was $28.4 million, including
$13.1 million in revenue generated from our clinical customers, and
$15.3 million in revenue generated from our biopharma customers during
the third quarter. Pharma Research and Development Services revenue was
$14.3 million.

2017 Outlook

Foundation Medicine’s business and financial outlook for 2017 is the
following:

  • The company expects 2017 revenue will be in the range of $135 million
    to $145 million.
  • The company is increasing clinical volume guidance and now expects to
    deliver between 64,000 and 66,000 clinical tests in 2017.
  • The company expects 2017 operating expenses will be in the range of
    $215 million and $225 million.
  • The company expects to advance its comprehensive genomic profiling
    assay, FoundationOne CDx, through the FDA and CMS Parallel Review
    process with a decision anticipated in the fourth quarter of 2017.
  • The company expects to continue reimbursement progress and pursue
    additional coverage decisions for its CGP assays.

Conference Call and Webcast Details

The company will conduct a conference call today, Wednesday, November
1st at 4:30 p.m. Eastern Time to discuss its financial performance for
the 2017 third quarter and other business activities, including matters
related to future performance. To access the conference call via phone,
dial 1-877-270-2148 from the United States or dial 1-412-902-6510
internationally. 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 FoundationOne CDx
and FoundationFocus
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, the timing of product development, and the expansion of
reimbursement progress, including any changes to any earlier guidance;
the benefits provided by a FDA-approved and CMS-covered FoundationOne
CDx and progress with the Parallel Review process with FDA and CMS; the
scope and timing of any approval of FoundationOne CDx as a medical
device by the FDA and any coverage decision by CMS; strategies for
achieving Medicare coverage decisions at the local or national level and
new and expanded coverage from third-party payers; and use of any funds
from its credit facility. 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 FoundationOne CDx as a medical
device or that CMS does not decide to offer FoundationOne CDx as a
covered benefit under Medicare; the FDA or CMS is delayed in the
completion of the Parallel Review process; the company’s 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 Balance Sheets

(In thousands)

(unaudited)

 
September 30, December 31,
2017 2016
Assets
Current assets:
Cash and cash equivalents $ 76,814 $ 63,617
Marketable securities 79,402
Accounts receivable 15,496 10,213
Inventory 10,400 10,438
Prepaid expenses and other current assets   4,612   5,251
Total current assets 107,322 168,921
Property and equipment, net 39,136 41,486
Restricted cash 2,305 1,395
Other assets   1,796   2,233
Total assets $ 150,559 $ 214,035
 
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable $ 16,178 $ 11,898
Accrued expenses and other current liabilities 28,246 20,578
Deferred revenue 1,998 5,851
Current portion of deferred rent   1,439   2,324
Total current liabilities 47,861 40,651
Other non-current liabilities 9,261 8,538
Indebtedness to Roche – non-current 30,000
Total stockholders’ equity   63,437   164,846
Total liabilities and stockholders’ equity $ 150,559 $ 214,035
 
             

FOUNDATION MEDICINE, INC.

Condensed Consolidated Statements of Operations

(In thousands, except share and per share data)

(unaudited)

 
Three Months Ended Nine Months Ended
September 30, September 30,
2017     2016 2017 2016
Molecular information services $ 28,368 $ 18,719 $ 79,763 $ 61,331
Pharma research and development services   14,290   10,707     24,227     26,710  
Total revenue 42,658 29,426 103,990 88,041
Costs and expenses:
Cost of molecular information services 19,128 15,946 58,727 39,291
Selling and marketing 16,556 14,654 50,107 42,928
General and administrative 17,001 13,012 49,926 34,739
Research and development   22,399   17,238     68,657     49,194  
 
Total costs and expenses   75,084   60,850     227,417     166,152  
 
Loss from operations (32,426 ) (31,424 ) (123,427 ) (78,111 )
Other (expense) income, net:
Interest (expense) income, net (278 ) 142 (132 ) 528
Other income   60       204      
 
Net loss $ (32,644 ) $ (31,282 ) $ (123,355 ) $ (77,583 )
 
Net loss per common share applicable to common stockholders, basic
and diluted
$ (0.90 ) $ (0.90 ) $ (3.45 ) $ (2.24 )
 
Weighted-average common shares outstanding, basic and diluted 36,086,169 34,949,785 35,726,711 34,701,013
 

Contacts

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

Source: Foundation Medicine, Inc.

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