On february 23, 2016 Foundation Medicine (NASDAQ: FMI) reported financial and operational results for the fourth quarter and year ended December 31, 2015 (Press release, Foundation Medicine, FEB 23, 2016, View Source [SID:1234509156]). Highlights for the quarter and year included:

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Fourth quarter revenue of $26.1 million, 39% year-over-year growth;

8,286 clinical tests reported in the fourth quarter, 15% year-over-year growth;

Full year 2015 revenue of $93.2 million, 53% year-over-year growth;

32,998 clinical tests reported in 2015, 36% year-over-year growth;

Improving patient access to comprehensive genomic profiling by signing a national agreement with United Healthcare for FoundationOne in metastatic non-small cell lung cancer. Additionally, Palmetto GBA, a Medicare Administrative Contractor (MAC), announced a final local coverage determination for comprehensive genomic profiling in a subset of patients with non-small cell lung cancer;

Broadening molecular information solutions with the addition of PatientMatchTM, GeneKitTM and SmartTrialsTM; and,

Expanding FoundationCORE molecular information knowledgebase to more than 68,000 cases.

The company reported total revenue of $26.1 million in the fourth quarter of 2015, compared to $18.7 million in the fourth quarter of 2014. Revenue from clinical testing in the fourth quarter of 2015 was $12.0 million, compared to $10.3 million in the fourth quarter of 2014. Total revenue for the year ended December 31, 2015 was $93.2 million, compared to $61.1 million in 2014.

The company reported 8,286 clinical tests, which includes 7,382 FoundationOne tests and 904 FoundationOne Heme tests, in the fourth quarter of 2015, a 15% increase from the total reported clinical tests in fourth quarter of 2014. An additional 3,104 tests were reported to pharmaceutical partners in the fourth quarter of 2015. The company reported 32,998 clinical tests, which includes 29,076 FoundationOne tests and 3,922 FoundationOne Heme tests, for the full year 2015, a 36% increase compared to the total reported clinical tests in 2014.

Revenue from pharmaceutical partners was $14.1 million in the fourth quarter, representing a 68% increase from the same period in 2014 and a 20% increase from the third quarter of 2015. For the full year, revenue from pharmaceutical partners was $44.0 million, an 80% increase from the $24.4 million in 2014. These increases in revenue from pharmaceutical partners highlight the company’s leading and broadening role within targeted oncology drug development.

"In 2015, Foundation Medicine made continued progress across the oncology ecosystem by delivering valuable insights from our molecular information platform to clinicians, payers and biopharmaceutical companies," stated Michael J. Pellini, M.D., chief executive officer of Foundation Medicine. "As we look ahead to 2016, we are poised for continued growth and expect to drive value both near and long term through product innovation, commercial execution and further integration of our molecular information platform to enable precision medicine."

The company’s cancer knowledgebase, FoundationCORE, grew to more than 68,000 clinical cases. FoundationCORE is a unique asset and critical component of the value that Foundation Medicine delivers to its biopharmaceutical and physician customers.

Total operating expenses for the fourth quarter of 2015 were approximately $34.0 million compared with $25.1 million for the fourth quarter of 2014. For the full year, operating expenses were $143.5 million, compared to $86.9 million in 2014. Net loss was $19.0 million in the fourth quarter of 2015, or a $0.55 loss per share, and net loss for the full year was $89.6 million, or a $2.73 loss per share. At December 31, 2015, the company held approximately $232.3 million in cash, cash equivalents and marketable securities.

Recent Highlights:

Initiated a prospective clinical study with Horizon Healthcare Services and Clinical Outcomes Tracking Analysis (COTA) to measure changes in survival benefit and total cost savings achieved among patients with previously untreated metastatic non-small cell lung cancer who undergo comprehensive genomic profiling with FoundationOne.

Announced a collaboration agreement with Mirati Therapeutics to develop a companion diagnostic test using the FoundationOne platform for Mirati’s kinase inhibitor, glesatinib.

Launched a circulating tumor DNA (ctDNA) assay to biopharmaceutical partners. The Company is on track to launch its ctDNA assay, FoundationACT, to its clinical customers during the first quarter of 2016.

Throughout the fourth quarter, the Company presented clinical data at seven medical conferences, including four podium presentations and 20 posters, to further support its commercial and reimbursement strategies.

2016 Outlook

The company expects 2016 revenue will be in the range of $110 to $120 million.

The company expects to deliver between 37,000 and 40,000 FoundationOne and FoundationOne Heme clinical tests in 2016.

The company expects operating expenses will be in the range of $175 and $185 million.

The company plans to expand its offering of molecular information products with the commercial launch of its ctDNA assay in the first quarter 2016.

The company expects to expand upon reimbursement progress made in 2015 and drive additional coverage decisions.

On February 23, 2016 ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company focused on new cancer immunotherapies, reported the publication of a study in Scientific Reports, a journal of the Nature Publishing Group, describing the genetic editing of human leukocyte antigen (HLA) in hematopoietic stem cells as a means of broadening the human application of these and other cell therapies (Press release, Ziopharm, FEB 23, 2016, View Source [SID:1234509153]). The article, titled "Genetic editing of HLA expression in hematopoietic stem cells to broaden their human application", is available online first at View Source

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Laurence Cooper, M.D., Ph.D., Chief Executive Officer of ZIOPHARM and senior author of the journal article, noted: "Genetic editing of HLA expression is a step towards generating universal biological products, where one donor’s cells may become suitable for sustained engraftment in multiple unrelated recipients. Unlocking the method by which HLA repertoire can be modified is one key to achieving this goal and fully harnessing the potential for off-the-shelf (OTS) therapies in immuno-oncology applications. Together with our partners at Intrexon and MD Anderson, we are bringing to bear multiple technologies to advance the findings of these studies and achieve this objective, with the goal of deploying it across our T-cell and natural killer (NK)-cell therapy platforms."

Transplantation of allogeneic, or donor-derived, hematopoietic stem cells (HSCs) into recipients with hematologic disorders is used to restore bone marrow function, termed hematopoiesis. Finding a suitable donor can be challenging due to the need to match the constellation of HLA with the recipient. For the study, researchers at The University of Texas MD Anderson Cancer Center eliminated expression of one set of HLA molecules, termed HLA-A, on donor HSC using artificial zinc finger nucleases. Other HLA molecules, such as HLA B and C remained expressed to help prevent elimination by resident NK cells. Following genetic editing, the HSCs maintained their ability to engraft and reconstitute hematopoiesis. This paper reveals that genetically altered HSC harvested from a small pool of donors will then match with a large number of unrelated recipients, which has two implications. First, it broadens the number of recipients who might benefit from bone marrow transplantation, which has particular appeal for racial minorities underserved by the current genetic makeup of unrelated donors. Second, it paves the way for generating OTS cells that are HLA matched with multiple recipients, even though they were obtained from one donor.

ZIOPHARM is developing various cell-based immuno-oncology programs, including CAR-T, TCR and NK adoptive cell-based therapies, in collaboration with its partner Intrexon Corporation (NYSE:XON) and MD Anderson.

On February 23, 2016 Merck (NYSE:MRK), known as MSD outside the United States and Canada, reported that the Board of Directors has declared a quarterly dividend of $0.46 per share of the company’s common stock for the second quarter of 2016 (Press release, Merck & Co, FEB 23, 2016, View Source [SID:1234509150]). Payment will be made on April 7, 2016, to shareholders of record at the close of business on March 15, 2016.

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On February 23, 2016 Insys Therapeutics, Inc. (NASDAQ:INSY) ("Insys" or "the Company") reported financial results for the three- and twelve-month periods ended December 31, 2015 (Filing, 8-K, Insys Therapeutics, FEB 23, 2016, View Source [SID:1234509148]).

Highlights of and subsequent to the fourth quarter of 2015 include:

● Total net revenue increased to $91.1 million, compared to $66.5 million for the fourth quarter of 2014;

● Revenue from Subsys (fentanyl sublingual spray) was $91.1 million, up 38% compared with fourth quarter 2014 revenue of $66.1 million;

● Net income was $17.0 million, or $0.24 per basic and $0.22 per diluted share, compared to net income of $9.3 million, or $0.13 per basic and diluted share, for the fourth quarter of 2014;

● Cash, cash equivalents and investments were $202.3 million as of December 31, 2015; and

● Enrolled the first patient in our Phase II clinical study for the treatment of infantile spasms (IS) using our pharmaceutical CBD (CBD) product candidate.

"2015 was another year of solid growth coupled with steady R&D progress, and we believe 2016 will be a pivotal year for the Company," said Dr. John N. Kapoor, Chairman, President and Chief Executive Officer, of Insys Therapeutics. "We are focused on the anticipated regulatory approval and subsequent launch of our second commercial product, Syndros, which has a PDUFA date of April 1st of this year. We believe Syndros can become a new treatment option for patients suffering from chemotherapy induced nausea and vomiting, as well as those fighting anorexia associated with AIDS.

"With respect to our pipeline, we continue to make progress across our platform of sublingual spray products. We also continue to advance our research and clinical efforts using our CBD product candidates. "As we focus on building a solid foundation, we are confident in our ability to take Insys to the next level and drive value for our shareholders," concluded Dr. Kapoor.

Fourth Quarter 2015 Financial Results

Net revenue for the fourth quarter of 2015 was $91.1 million compared to $66.5 million for the fourth quarter of 2014, an increase of 38%.

Gross margin was 93% for the fourth quarter of 2015 compared with 91% for the fourth quarter of 2014.

Sales and marketing expense was $18.5 million during the fourth quarter of 2015, or 20% of net revenue, compared to $17.3 million, or 26% of net revenue, for the fourth quarter of 2014.

Research and development expense increased to $14.6 million for the fourth quarter of 2015, compared to $12.9 million for the fourth quarter of 2014, mainly as a result of Insys’ continued pipeline development investments during 2015.

General and administrative expense increased to $21.8 million for the fourth quarter of 2015, and included a non-cash equity compensation charge of $5.0 million incurred in connection with the departure of the former CEO, compared to $14.2 million for the fourth quarter of 2014.

Income tax expense was $12.9 million for the fourth quarter of 2015.

Net income for the fourth quarter of 2015 was $17.0 million, or $0.24 per basic and $0.22 per diluted share, compared to net income of $9.3 million, or $0.13 per basic and diluted share, for the fourth quarter of 2014. Non-GAAP adjusted net income for the fourth quarter of 2015 was $27.2 million, or $0.36 per diluted share, compared to non-GAAP adjusted net income of $19.5 million, or $0.26 per diluted share, in the prior year quarter. The reconciliation of net income to non-GAAP adjusted net income is included at the end of this press release.

2015 Financial Results

Net revenue for the year ended December 31, 2015 was $330.8 million compared to $222.1 million for the year ended December 31, 2014, an increase of 49%.

Gross margin for 2015 was 91%, compared with 90% for 2014.

Sales and marketing expense was $80.7 million during 2015, or 24% of net revenue, compared to $58.1 million, or 26% of net revenue, for 2014.

Research and development expense increased to $55.3 million for 2015, or 17% of net revenue, compared to $33.1 million, or 15% of revenue, for 2014, mainly as a result of Insys’ continued pipeline development investments during 2015.

General and administrative expense increased to $64.1 million for 2015, or 19% of net revenue, compared to $44.3 million, or 20% of net revenue, for 2014.

Income tax expense was $34.5 million for 2015, reflecting an effective corporate tax rate of 37%.

Net income for 2015 was $58.5 million, or $0.82 per basic and $0.77 per diluted share, compared to net income of $38.0 million, or $0.55 per basic and $0.52 per diluted share, for 2014. Non-GAAP adjusted net income, which adjusts for non-cash stock compensation expense and non-cash income tax expense, was $104.2 million, or $1.38 per diluted share, compared to $78.7 million, or $1.07 per diluted share, in the prior year. The reconciliation of net income to Non-GAAP adjusted net income is included at the end of this press release.

Liquidity

The Company had $202.3 million in cash, restricted cash, cash equivalents, and short-term and long-term investments, no debt, and $253.7 million in stockholders’ equity as of December 31, 2015.

As previously disclosed, on November 5, 2015, the Insys’ Board of Directors approved the repurchase of up to $50 million of the Company’s common stock. As of February 22, 2016, the Company had expended approximately $27.4 million to repurchase approximately 1.1 million shares of common stock outstanding. Insys intends to finance the remainder of the share repurchase program through available cash on hand.

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On February 23, 2016 Eagle Pharmaceuticals, Inc. (NASDAQ:EGRX) ("Eagle" or the "Company") reported that the United States Patent and Trademark Office (USPTO) has granted U.S. Patent No. 9,265,831, which pertains to liquid bendamustine hydrochloride (HCl) formulations(Press release, Eagle Pharmaceuticals, FEB 23, 2016, View Source [SID:1234509140]). The patent issued today expires on January 28, 2031. This new patent, along with five previously issued Patents (Nos. 8,609,707, 8,791,270*PED, 9,000,021, 9,034,908, and 9,144,568), further expands and protects Eagle’s bendamustine HCI intellectual property estate. This grant brings the total number of Orange Book listed patents to six, with this latest patent to be included shortly.

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"Eagle continues to strengthen its bendamustine patent portfolio with now six Orange Book listed patents running from 2026-2033 and several more pending. The issuance of this new patent supports the long-term earnings potential of the bendamustine franchise products and further protects its longevity. Given the nature of our patent portfolio, the Company believes that it will be very difficult for any ANDA filers to design around these patents," said Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.

Under a February 2015 exclusive license agreement for BENDEKA (bendamustine hydrochloride) Injection, Teva Pharmaceuticals is responsible for all U.S. commercial activities for the product including promotion and distribution.