CAMBRIDGE, Mass.--(BUSINESS WIRE)--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:
- Reported 13,933 clinical tests in the first quarter, 55% year-over-year growth;
- Reported first quarter revenue of $26.3 million which included payment for FoundationOne® for patients with non-small cell lung cancer (NSCLC) under a Local Coverage Determination (LCD) by Palmetto GBA, the company’s Medicare Administrative Contractor in North Carolina;
- Announced a collaboration agreement with Bristol-Myers Squibb in the area of immuno-oncology (IO). BMS will leverage FMI’s molecular information platform to identify predictive biomarkers across multiple tumor types in patients enrolled in clinical trials investigating BMS’ cancer immunotherapies;
- Published 27 manuscripts in high-quality, peer-reviewed journals and delivered 37 podium and poster talks at various medical and scientific meetings; and,
- Increased FoundationCORE™, the company’s molecular information database, to more than 125,000 clinical cases.
“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™ CDxBRCA 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:
- The company expects 2017 revenue will be in the range of $135 million to $145 million.
- The company expects to deliver between 53,000 and 56,000 clinical tests in 2017.
- The company expects operating expenses will be in the range of $205 million and $215 million.
- The company expects to advance its universal, pan-cancer companion diagnostic assay through the FDA and CMS Parallel Review process with a decision in the second half of 2017.
- The company expects to expand upon reimbursement progress made in 2016 and drive additional coverage decisions for its CGP assays.
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.
