CAMBRIDGE, Mass.--(BUSINESS WIRE)--Foundation Medicine, Inc. (NASDAQ:FMI) today reported financial and operating results for its second quarter ended June 30, 2017. Results and business highlights for the quarter included: <\/p>\n
Foundation Medicine delivered a strong second quarter, highlighted by record clinical volume and total revenue, increased adoption of our molecular information solutions by both clinicians and biopharma partners, and importantly, improved cancer care for the patients we serve, said Troy Cox, chief executive officer of Foundation Medicine. In addition, we advanced the parallel review with FDA and CMS for FoundationOne CDx with the submission of our final module to the FDA in June, a significant milestone in the process. If approved, FoundationOne CDx would become the first pan-cancer universal companion diagnostic, a highly differentiated and valuable solution for patients, oncologists and biopharma partners. <\/p>\n
Foundation Medicine reported total revenue of $35.0 million in the second quarter of 2017, compared to $28.2 million in the second quarter of 2016. Revenue from biopharmaceutical customers was $22.1 million in the second quarter of 2017, compared to $18.9 million in the second quarter of 2016. The results of 4,762 tests were reported to biopharmaceutical customers in this years second quarter. <\/p>\n
Revenue from clinical testing in the second quarter of 2017 was $12.9 million, compared to $9.4 million in the second quarter of 2016. The company reported 15,924 tests to clinicians in the second quarter of 2017, a 55% increase from the same quarter last year. This number includes 12,442 FoundationOne tests, 1,608 FoundationOne Heme tests, 1,594 FoundationACT tests, and 280 FoundationFocus CDxBRCA tests. <\/p>\n
Total operating expenses for the second quarter of 2017 were approximately $57.7 million, compared with $45.5 million for the second quarter of 2016. The increase in operating expenses was partially driven by investments in the companys universal companion diagnostic assay, certain non-recurring cash and non-cash expenses, and investments in the companys technology infrastructure. Net loss was approximately $44.3 million in the second quarter of 2017, or a $1.24 loss per share. At June 30, 2017, the company held approximately $71.5 million in cash, cash equivalents and marketable securities. <\/p>\n
The company will now be reporting revenue in two components: Molecular Information Services and Pharma Research and Development Services. Molecular Information Services is revenue derived from commercially available platforms and services such as sample profiling, data access and SmartTrials, and includes revenue from both clinical and biopharma customers. Pharma Research and Development Services is revenue derived from work funded primarily by biopharma partners to develop new assays and other services. This new disclosure is intended to provide additional information related to the revenue and cost of revenue specifically related to the companys commercially available platforms and services. During the second quarter, Molecular Information Services revenue was $30.3 million, including $12.9 million in revenue generated from our clinical customers, and $17.4 million in revenue generated from our biopharma customers. Pharma Research and Development Services revenue was $4.7 million. <\/p>\n
On July 31st, Foundation Medicine entered into an agreement to expand its credit facility with Roche Finance from $100 million to $200 million. Any outstanding balance of the credit facility will convert to a term loan payable over a five-year period beginning on February 2, 2021. No funds were drawn under the credit facility at the time of the expansion. The company intends to use the proceeds to further fund product development, commercialization, corporate development initiatives and working capital. <\/p>\n
2017 Outlook <\/p>\n
Foundation Medicines business and financial outlook for 2017 is the following: <\/p>\n
Conference Call and Webcast Details <\/p>\n
The company will conduct a conference call today, Tuesday, August 1st at 4:30 p.m. Eastern Time to discuss its financial performance for the 2017 second 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 companys 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. <\/p>\n
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 patients unique cancer. The company offers a full suite of comprehensive genomic profiling assays to identify the molecular alterations in a patients cancer and match them with relevant targeted therapies, immunotherapies and clinical trials. Foundation Medicines 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<\/a> or follow Foundation Medicine on Twitter (@FoundationATCG). <\/p>\n Foundation Medicine, FoundationOneand FoundationACTare registered trademarks, and FoundationOne CDxand FoundationFocusare trademarks, of Foundation Medicine, Inc. <\/p>\n 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 companys business; the benefits of our products to physicians, biopharmaceutical companies, payers and patients in the treatment of cancer and personalized cancer care; the companys 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 aFDA-approved and CMS-covered FoundationOne CDx and progress with the Parallel Review process withFDAand CMS; the scope and timing of any approval of our universal companion diagnostic assay as a medical device by theFDAand any coverage decision by CMS; strategies for achievingMedicarecoverage 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 thattheFDA 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 underMedicare; theFDAor CMS is delayed in the completion of the Parallel Review process; the company's new facilities inNorth CarolinaandGermanydo not facilitate the company's ability to achieve it business objectives; the company's distribution partner outsidethe United Statesis not able to achieve market penetration in new and existing markets as quickly or as extensively as projected;Foundation Medicine'srelationships withthird-party or government payers do not increase or expand;Foundation Medicineis 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 Medicineis 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 Medicines 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 Medicines 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. <\/p>\n - Financial Tables to Follow - <\/p>\n FOUNDATION MEDICINE, INC. <\/p>\n Condensed Consolidated Balance Sheets <\/p>\n (In thousands) <\/p>\n (unaudited) <\/p>\n FOUNDATION MEDICINE, INC. <\/p>\n Condensed Consolidated Statements of Operations <\/p>\n (In thousands, except share and per share data) <\/p>\n (unaudited) <\/p>\n (44,258) <\/p>\n (28,994) <\/p>\n (46,301) <\/p>\n (1.24) <\/p>\n (0.84) <\/p>\n (2.55) <\/p>\n (1.34) <\/p>\n <\/p>\n See more here: <\/p>\n Foundation Medicine Announces 2017 Second Quarter Results and Recent Highlights - Business Wire (press release)<\/a><\/p>\n","protected":false},"excerpt":{"rendered":" CAMBRIDGE, Mass.--(BUSINESS WIRE)--Foundation Medicine, Inc. (NASDAQ:FMI) today reported financial and operating results for its second quarter ended June 30, 2017. Continue reading