On February 9, 2017 Atreca, Inc., a biotechnology company focused on developing novel therapeutics based on a deep understanding of the human immune response, reported the presentation of positive preclinical findings in its immuno-oncology program, generated via the Company’s Immune Repertoire Capture (IRC) technology platform (Press release, Atreca, FEB 22, 2017, View Source [SID1234522956]). Atreca’s IRC technology identifies and generates sequences of native antibodies and T cell receptors (TCRs) from active human immune responses, including natively paired and complete variable regions of receptors expressed by specifically selected B- and T-cells. New findings from Atreca’s lead program are being highlighted at the 24th annual Molecular Medicine TriConference, taking place at the Moscone North Convention Center in San Francisco, CA, February 19-24, 2017.

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In a presentation, titled "The Immune Repertoire Capture (IRC) Technology Platform," Daniel Emerling, Ph.D., Atreca’s Senior Vice President, Research, is presenting key preclinical findings today at 12:10 p.m. Pacific Time, including:

Atreca’s researchers have used IRC technology to generate functional antibodies from the active immune response of individuals with metastatic disease who experienced a response to therapy.
Several patient-derived antibodies have been shown to bind tumor tissue but not normal tissue, and some antibodies bind multiple tumor types, including lung and breast adenocarcinoma, and renal cell carcinoma.
In a preclinical syngeneic in vivo tumor model, administration of the human variable regions derived from a particular patient antibody (linked to a mouse constant region) resulted in clearance of tumor in a majority of the animals, with concomitant infiltration of immune system cells into tumor tissue. Potential synergy with a checkpoint inhibitor was also observed.
"We are thrilled with the continued momentum of our programs based on successful anti-tumor immune responses in cancer patients undergoing treatment," stated N. Michael Greenberg, PhD, Atreca’s Chief Scientific Officer. "Our most recent data validate our next-generation approach in monotherapy as well as combination therapy, potentially addressing the substantial need to enhance patient responses to checkpoint inhibition. The unique features and capabilities of our platform allow us to pursue diverse applications outside of cancer as well, and we look forward to our progress as we advance toward IND-enabling studies in our lead program."

Atreca applies IRC to generate sequences of native antibodies and TCRs from cancer patients who have responded well to immunotherapy and other treatments, patients with autoimmune disease, vaccinated subjects, and patients who resolve infections. Analyses of the resulting essentially unbiased and error-free repertoires yield insights into immunology, as well as potent antibodies targeting tumors, pathogens, and autoimmune epitopes.

On February 22, 2017 Cleveland BioLabs, Inc. (NASDAQ:CBLI) reported financial results and development progress for the fourth quarter and year ended December 31, 2016 (Filing, 8-K, Cleveland BioLabs, FEB 22, 2017, View Source [SID1234517857]).

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Cleveland BioLabs reported a net loss, excluding minority interests, of $(1.2) million for the fourth quarter of 2016, or $(0.11) per share, compared to a net loss of $(1.4) million, or $(0.13) per share, for the fourth quarter of 2015. Net loss, excluding minority interests, for full year 2016 was $(2.7) million, or $(0.24) per share, compared to a net loss of $(12.6) million, or $(1.79) per share, for full year 2015.

As of December 31, 2016, the Company had $15.2 million in cash, cash equivalents and short-term investments, which, based on the Company’s current operational plan, is estimated to fund operations for at least one year beyond the filing date of our Form 10-K.

Yakov Kogan, Ph.D., MBA, Chief Executive Officer, stated, "The past year was one of significant progress for CBLI. We commenced or continued clinical studies designed to further substantiate the potential of our Toll-like receptor agonists, entolimod, CBLB612 and Mobilan."

"The pursuit of commercialization for entolimod as a medical radiation countermeasure remains our top priority," continued Dr. Kogan. "We are working with the U.S. Food and Drug Administration (FDA) to confirm the bio-comparability of two formulations of entolimod. As requested by the Agency, we have completed the side-by-side analytical comparability analysis of these formulations and plan to submit the report to the Agency in the first quarter of 2017. Once the FDA has reviewed these data and provided its consent, the bio-comparability study in non-human primates will commence. Following completion of the study and discussion of the submitted study results with the FDA, we expect the Agency to resume the review of our pre-EUA dossier. Products with pre-EUA status may be purchased by certain US government stakeholders for stockpiling in the event of a disaster and we believe achievement of this status may also increase interest from foreign governments. In addition, we are evaluating steps needed to file a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA), and have taken preliminary action with the EMA, which has granted entolimod orphan drug designation for the treatment of acute radiation syndrome, and we continue to evaluate other foreign markets."

Other Operational Highlights

•
Entolimod Oncology Indications. We have completed dosing of 40 patients in a clinical study of the safety and tolerability of entolimod as a neo-adjuvant therapy in treatment-naïve patients with primary colorectal cancer who are recommended for surgery. The goal is to accumulate additional clinical data regarding immune cell response to administrations of entolimod to guide future oncology development. The analysis of the data is ongoing.
•
CBLB612. We have also completed dosing in a Phase 2, randomized, placebo-controlled clinical study of CBLB612 as myelosuppressive prophylaxis in patients with breast cancer receiving doxorubicin-cyclophosphamide chemotherapy and data analysis of this study is in progress.
•
Mobilan. Two randomized, placebo-controlled, dose-ranging studies of Mobilan in men with prostate cancer are currently ongoing in the Russian Federation.

All of these studies are being conducted in the Russian Federation and were supported by development contracts with the Russian Federation Ministry of Industry and Trade, or MPT.

Further Financial Results

Revenue for the fourth quarter of 2016 was $1.0 million compared to $1.3 million for the fourth quarter of 2015. Revenue for full year 2016 was $3.5 million compared to $2.7 million for full year 2015. The revenue changes are primarily due to increased revenue from our Joint Warfighter Medical Research Program (JWMRP) contract with the Department of Defense (DoD) and our recently completed MPT contracts at BioLab 612 and Panacela which were partially offset by a decrease in service contract revenue from Incuron.

Research and development (R&D) costs for the fourth quarter of 2016 were $2.2 million compared to $1.9 million for the fourth quarter of 2015. R&D costs for the full year 2016 decreased to $6.5 million compared to $7.1 million for the full year 2015. The research and development changes were primarily attributable to our streamlined focus of pursuing commercialization efforts for entolimod’s biodefense indication in the United States and European Union, which increased certain R&D costs, but were partially offset by contract performance against the recently modified scope of work for our JWMRP contract to address the formulation questions raised by the FDA during its review of the pre-EUA dossier, and completion of our MPT contracts, which increased certain R&D costs during the year.

General and administrative costs (G&A) for the fourth quarter of 2016 were $0.7 million compared to $1.2 million for the fourth quarter of 2015. G&A costs for full year 2016 decreased to $3.4 million compared to $6.4 million for full year 2015. These decreases were primarily attributable to reductions in personnel and outside professional costs.

At December 31, 2016 the Company had 10,987,166 shares of common stock outstanding. In addition, the Company has 233,367 shares of common stock reserved for issuance pursuant to outstanding stock options with a weighted average exercise price of $41.98 and 2,148,741 shares of common stock reserved for issuance pursuant to outstanding warrants exercisable at a weighted average price of $11.04.

On February 27, 2017 Fresenius Medical Care reported strong 2016 results and ambitious growth targets for 2017(Press release, Fresenius, FEB 22, 2017, View Source [SID1234517838]).

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Targets for 2016 achieved
Group revenue +7% in 2016 (+7% adjusted1)
Strong EBIT growth of 13% in 2016, resulting in improved EBIT margin of 14.7%
Net income +21% (+16% adjusted2)
Very good performance in Health Care Services, particularly in North America
Care Coordination continues to deliver significant organic revenue growth (+20%)
Dividend proposal of €0.96 (+20%) for fiscal year 2016
Fourth quarter 2016 key figures
US$ million Q4 2016
Q4 2015

Net revenue 4,687 4,348 +8%
Operative income (EBIT) 786 662 +19%
Net income3
388 317 +23%
Basic earnings per share (in $)
1.27 1.04 +22%

Full year 2016 key figures
US$ million Q1-4 2016 Q1-4 2015
Net revenue 17,911 16,738 +7%
Operating income (EBIT) 2,638 2,327 +13%
Net income3 1,243 1,029 +21%
Net income adjusted2 1,228 1,057 +16%
Basic earnings per share (in $) 4.07 3.38 +20%
Dividend proposal (per share) 0.96 0.80 +20%
1At constant currency, excluding acquisitions in 2015 and 2016
2Net income attributable to shareholders of Fresenius Medical Care AG & Co. KGaA, adjusted for acquisitions and based on an adjusted 2015 net income of $1,057m
3Net income attributable to shareholders of Fresenius Medical Care AG & Co. KGaA
"In our 20th anniversary year, we were able to mark another record year for Fresenius Medical Care and for our shareholders. I am pleased to confirm that we have achieved our financial targets for 2016. We were able to deliver a strong business performance across all segments and realize the planned savings of our Global Efficiency Program thanks to the outstanding dedication and commitment of our employees," said Rice Powell, Chief Executive Officer of Fresenius Medical Care. "Our path to value-based care continues. We are further investing in the dynamic growth of our Care Coordination activities as well as the innovative development of our core dialysis business. For 2017, we have again set ourselves ambitious targets and will continue to deliver high-quality care for our patients."
Revenue
Net revenue for the full year 2016 increased by 7% and reached $17,911 million (+8% at constant currency), driven by a strong performance in Health Care Services. Health Care Services revenue increased by 8% to $14,519 million (+9% at constant currency), mainly due to strong organic growth supported by positive price and volume effects. Dialysis Products revenue increased by 1% to $3,392 million (+4% at constant currency). The growth at constant currency was primarily supported by higher sales of dialyzers and machines. This was partially offset by lower sales of renal pharmaceuticals, resulting from the sale of our European marketing rights for certain renal pharmaceuticals to our joint venture, Vifor Fresenius Medical Care Renal Pharma, in 2015.
Net revenue in the fourth quarter of 2016 increased by 8% to $4,687 million (+9% at constant currency), mainly driven by higher Health Care Services revenue. Health Care Services revenue increased by 10% to $3,799 million (+10% at constant currency), mainly driven by positive price as well as volume effects. Dialysis Products revenue reached the same level as in the previous year ($888 million), an increase of 2% at constant currency.
Earnings
Operating income (EBIT) for the full year 2016 increased by 13% to $2,638 million, leading to an improved operating income margin of 14.7% (+80 basis points). The development of the EBIT margin was supported by a strong margin development, particularly in North America.
In the fourth quarter of 2016, operating income rose by 19% to $786 million, leading to a strong operating income margin of 16.8% (+160 basis points). The increase in EBIT margin was positively affected by the prior year impact from the GranuFlo settlement expense as well as the margin improvement in North America and Asia-Pacific and a favorable impact from Corporate due to reduced legal and consulting expenses.
Net interest expense for the full year 2016 increased by 4% to $406 million, particularly due to lower interest income as a result of the repayment of interest bearing notes receivables in the fourth quarter of 2015. This was partially offset by a lower debt level driven by a favorable cash flow development.
For the same reasons, net interest expense in the fourth quarter of 2016 increased by 11% to $98 million.

Income tax expense for the full year 2016 increased by 10% to $683 million. This translates into an effective tax rate of 30.6%, a decrease of 150 basis points compared to the same period of 2015. This decrease was supported by lower tax expense as a result of released tax liabilities, as well as the prior year impact from the non-tax deductible loss from the divestiture of our dialysis service business in Venezuela.

In the fourth quarter of 2016, income tax expense were $212 million, translating into an effective tax rate of 30.8% (-60 basis points).

For the full year 2016, net income attributable to shareholders of Fresenius Medical Care AG & Co. KGaA grew by 21% to $1,243 million and by 16% to $1,228 million on an adjusted basis1. Based on approximately 305.7 million shares (weighted average number of shares outstanding), basic earnings per share (EPS) increased from $3.38 to $4.07 (+20%). The increase in the weighted average number of shares outstanding was the result of stock options exercised.

12015 net income attributable to shareholders of Fresenius Medical Care AG & Co. KGaA adjusted for the impacts of (i) the 2015 settlement cost for an agreement in principle for the GranuFlo case ($37 million) and (ii) acquisitions in 2015 ($9 million), resulting in an adjusted net income of $1,057 million; 2016 net income adjusted for 2016 acquisitions ($15 million), resulting in an adjusted net income of $1,228 million.

In the fourth quarter of 2016, net income attributable to shareholders of Fresenius Medical Care AG & Co. KGaA grew by 23% to $388 million. Based on approximately 306.2 million shares (weighted average number of shares outstanding), basic EPS increased from $1.04 to $1.27 (+22%).

Segment development
North America: For the full year 2016, North America revenue increased by 9% to $12,886 million (72% of total revenue). Health Care Services revenue grew by 10% to $11,982 million, driven by higher Dialysis Care revenue (+7% to $9,675 million) and increased Care Coordination revenue (+23% to $2,307 million). Dialysis treatments rose by 4%. As of the end of 2016, we had 188,987 patients being treated at the 2,306 clinics that we own, operate or manage in North America. Dialysis Products revenue increased by 3% to $904 million, supported by higher sales of machines, dialyzers and peritoneal dialysis products partially offset by lower sales of renal pharmaceuticals and bloodlines. Operating income in North America came in at $2,119 million (+18%). The operating income margin reached a level of 16.4% (+120 basis points) as a result of lower cost from health care supplies, a higher volume of dialysis treatments with commercial payers and the prior year impact from the GranuFlo settlement expense. The positive effect was partially offset by higher personnel expense and a cost impact related to the vesting of long term incentive plan grants. The operating income margin of Care Coordination decreased to 2.6%, mainly driven by increased costs for hospitalist and intensivist services.

In the fourth quarter of 2016, North America revenue increased by 9% to $3,374 million, mainly supported by higher dialysis treatments coupled with an increase in US revenue per treatment ($356, +$8). Care Coordination contributed revenues of $603 million (+20%). Operating income increased by 23% to $634 million in the fourth quarter, mainly supported by the prior year impact from the GranuFlo settlement expense and higher revenue from commercial payers as well as lower cost from health care supplies. This was partially offset by higher personnel expense and an unfavorable impact from Care Coordination. The Care Coordination EBIT margin of -1.1% in North America was mainly impacted by higher costs related to bad debt reserves for hospitalist and intensivist services.

EMEA: For the full year 2016, EMEA revenue increased by 1% to $2,667 million (+4% at constant currency). Health Care Services revenue for the EMEA segment increased by 6% to $1,294 million (+9% at constant currency), mainly as the result of contributions from acquisitions and same market treatment growth, partially offset by the negative effect of exchange rate fluctuations. Dialysis treatments increased by 8%. As of the end of 2016, we had 59,767 patients being treated at the 711 dialysis clinics that we own, operate or manage in EMEA. Dialysis Products revenue decreased by 2% to $1,373 million (flat at constant currency), mainly due to lower sales of renal pharmaceuticals (whose marketing rights were sold in 2015), dialyzers and machines, mostly offset by increased sales of bloodlines and products for acute care treatments. Operating income in EMEA decreased by 9% to $524 million for the full year. The operating income margin decreased to 19.7% (-220 basis points), mainly due to the prior year impact from a gain from the sale of European marketing rights for certain renal pharmaceuticals, higher bad debt expense, lower income from equity method investees and unfavorable foreign exchange effects.

In the fourth quarter of 2016, EMEA revenue increased by 2% to $684 million (+4% at constant currency), mainly driven by a strong performance in Health Care Services (revenue +7% to $327 million, +10% at constant currency). Dialysis Products revenue in EMEA declined by 3% to $357 million in the fourth quarter (flat at constant currency). Operating income in EMEA decreased by 25% to $130 million due to the gain from the sale of European marketing rights for certain renal pharmaceuticals in 2015, lower income from equity method investees driven by higher product development cost, IT project cost as well as higher bad debt expense.

Asia-Pacific: Total revenue for the Asia-Pacific segment increased by 9% to $1,632 million (+8% at constant currency) for the full year 2016. Health Care Services revenue increased by 9% to $730 million (+3% at constant currency), based on an increase of 6% in dialysis treatments. With an 8% growth in revenue to $902 million (+12% at constant currency), the product business showed an excellent sales performance across the entire dialysis products range. As of the end of 2016, we had 29,328 patients being treated at the 374 dialysis clinics that we own, operate or manage in Asia-Pacific. Operating income increased by 7% to $319 million. Due to unfavorable foreign exchange effects and costs associated with changes in the Management Board, the EBIT margin decreased slightly to 19.6% (-20 basis points).

In the fourth quarter of 2016, revenue in the Asia-Pacific segment increased by 10% to $433 million (+8% at constant currency), driven by a good revenue growth in both the Health Care Services business (+12%/+5% at constant currency) as well as the products business (+8%/+10% at constant currency). Operating income increased by 20% to $94 million. The EBIT margin increased accordingly to 21.8% (+180 basis points) in the fourth quarter, mainly due to the favorable effect of prior year costs related to customs duties in India.

Latin America: Total revenue for the Latin America segment decreased by 7% to $712 million (+13% at constant currency) for the full year 2016. Health Care Services revenue decreased by 9% to $513 million (+15% at constant currency), mainly as a result of the negative effect of exchange rate fluctuations and the effect of closed or sold clinics (mainly Venezuela and Brazil), partially offset by increases in organic revenue per treatment. Dialysis treatments decreased by 3%, mainly due to the effect of closed or sold clinics. As of the end of 2016, we had 30,389 patients being treated at the 233 dialysis clinics that we own, operate or manage in Latin America. Dialysis Products revenue for the full year remained unchanged at $199 million (+7% at constant currency). The growth at constant currency was mainly driven by increased sales of dialyzers, hemodialysis solutions and concentrates, partially offset by lower sales of peritoneal dialysis products and machines. Operating income increased by a strong 37% to $66 million, mainly due to the prior-year loss from the divestment of the dialysis service business in Venezuela. The EBIT margin in Latin America increased to 9.2% (+290 basis points) for the full year, mainly driven by the above mentioned prior-year loss.
In the fourth quarter of 2016, revenue in the Latin America segment increased by 1% to $192 million (+13% at constant currency), mainly driven by a strong increase in Dialysis Products revenue (+11% to $56 million, +7% at constant currency). The growth at constant currency was the result of higher sales of dialyzers as well as hemodialysis solutions and concentrates, partially offset by lower sales of machines. Health Care Services revenue decreased by 3% to $136 million (+14% at constant currency), strongly impacted by unfavorable foreign exchange effects. Operating income in Latin America decreased by 18% to $19 million in the fourth quarter, mainly driven by higher bad debt expense. The EBIT margin decreased accordingly to 9.7% (-230 basis points).

Cash flow
In the full year 2016, the company generated net cash provided by operating activities of $2,140 million ($1,960 million for full year 2015), representing 11.9% of revenue, and thereby clearly reaching our target for 2016 (operating cash flow > 10% of revenue). The increase was mainly the result of improved inventory levels in North America driven by lower health care supplies, as well as increased earnings. This was partially offset by unfavorable effects from other working capital items and a $100 million discretionary cash contribution to pension plan assets in the United States. The number of DSO (days sales outstanding) as of December 31, 2016 was 70 days, a decrease of 1 day compared to the previous year.

In the fourth quarter of 2016, the company generated net cash provided by operating activities of $844 million, representing 18% of revenue ($548 million in the fourth quarter of 2015). The increase was primarily attributable to higher net income, a favorable effect from DSO and deferred income tax payments in the United States.
Employees

As of December 31, 2016, Fresenius Medical Care had 109,319 employees (full-time equivalents) worldwide, compared to 104,033 employees at the end of December 2015. This increase of 5% was primarily attributable to our continued organic growth and acquisitions.

Recent events: Acquisition of a majority stake in Cura Group
In February 2017, Fresenius Medical Care announced the acquisition of a majority stake in Cura Group ("Cura"), a leading operator of high-quality day hospitals in Australia. In its 19 private day hospitals across Australia, Cura provides a variety of specialized ambulant services, such as ophthalmology and orthopedic surgeries in an outpatient setting. Cura was established in 2008 and generated revenue of AU$127 million (€87 million) in the financial year 2015/2016. This acquisition allows Fresenius Medical Care to further leverage its core competence in operating outpatient facilities, extend its dialysis network and thereby lay the foundation for future growth in the Australian market. This transaction is subject to remaining shareholder agreements and authority approval.

Guidance 2017
Beginning January 1, 2017, Fresenius Medical Care AG & Co. KGaA focusses its reporting on financial statements in accordance with International Financial Reporting Standards (IFRS) in Euro currency. For full year 2017, the company expects revenue to grow by 8 to 10% at constant currency, based on 2016 revenue of €16,570 million. Net income attributable to shareholders of Fresenius Medical Care AG & Co. KGaA is expected to grow by 7 to 9% at constant currency, based on 2016 net income of €1,144 million. The effects of the agreement with the U.S. Departments of Veterans Affairs and Justice are excluded.

Vision 2020
In April 2014, Fresenius Medical Care set medium-term targets on a constant-currency, US-GAAP basis. The company targeted an average, annual revenue increase of about 10 percent through 2020. At current exchange rates, this would result in a 2020 revenue target of €24 billion on an IFRS basis. Over the same period, Fresenius Medical Care expects an average annual growth of net income attributable to shareholders of Fresenius Medical Care AG & Co. KGaA in the high-single-digit percentage range. These goals are unchanged.

On February 22, 2017 Foundation Medicine (NASDAQ:FMI) reported financial and operational results for the fourth quarter and year ended December 31, 2016 (Press release, Foundation Medicine, FEB 22, 2017, View Source [SID1234517808]). Highlights for the quarter and year included:

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Fourth quarter revenue of $28.8 million, 11% year-over-year growth;
Full year 2016 revenue of $116.9 million, 25% year-over-year growth;
12,788 clinical tests reported in the fourth quarter, 54% year-over-year growth;
43,686 clinical tests reported in 2016, 32% year-over-year growth;
Received FDA approval of FoundationFocus CDxBRCA as a companion diagnostic for Rubraca (rucaparib) for the treatment of women with ovarian cancer. FoundationFocus is the first next generation sequencing companion diagnostic approved by the FDA and marks important progress towards the development of the company’s universal pan-cancer companion diagnostic assay;
Made progress in expanding patient access to comprehensive genomic profiling (CGP) through Palmetto, a Medicare administrative contractor in North Carolina, who issued draft Local Coverage Determinations covering CGP at initial diagnosis for advanced or metastatic melanoma, colorectal cancer and ovarian cancer patients;
Together with Flatiron Health, launched a clinico-genomic database containing information on 20,000 patients designed to help researchers and biopharmaceutical companies accelerate the development of targeted therapies and immunotherapies to treat cancer; and,
Increased FoundationCORE, the company’s molecular information database, to more than 100,000 clinical cases.
"Since its inception just six years ago, Foundation Medicine has established itself as the clear leader in molecular information and precision medicine in oncology," stated Troy Cox, chief executive officer of Foundation Medicine. "We believe 2017 will be a year of continued growth and value creation particularly as we progress through Parallel Review of FoundationOne with FDA and CMS and simultaneously collaborate with healthcare providers, payers and biopharma partners to apply our molecular information to accelerate personalized cancer care."

The company reported total revenue of $28.8 million in the fourth quarter of 2016, compared to $26.1 million in the fourth quarter of 2015. Total revenue for the year ended December 31, 2016 was $116.9 million, compared to $93.2 million in 2015.

Revenue from biopharmaceutical partners was $19.0 million in the fourth quarter, representing a 35% increase from the same period in 2015. For the full year, revenue from biopharmaceutical partners was $78.8 million, a 79% increase from $44.0 million in 2015. These increases in revenue from biopharmaceutical partners highlight the company’s continued leading and broadening role within targeted oncology drug development.

Revenue from clinical testing in the fourth quarter of 2016 was $9.8 million, compared to $12.0 million in the fourth quarter of 2015. For the full year, revenue from clinical testing was $38.1 million, compared to $49.2 million in 2015. The decreases were driven by various factors, the most significant of which was the transition in-network with a large national payer for stage IV NSCLC testing, which resulted in the termination of out of network payments for testing in other indications.

The company reported 12,788 clinical tests, which includes 10,108 FoundationOne tests, 1,407 FoundationOne Heme tests and 1,273 FoundationACT tests, in the fourth quarter of 2016, a 54% increase from the total reported clinical tests in the fourth quarter of 2015. An additional 1,860 tests were reported to biopharmaceutical partners in the fourth quarter of 2016. The company reported 43,686 clinical tests, which includes 36,327 FoundationOne tests, 5,008 FoundationOne Heme tests and 2,351 FoundationACT tests, for the full year 2016, a 32% increase compared to the total reported clinical tests in 2015.

Total operating expenses for the fourth quarter of 2016 were approximately $47.1 million compared with $34.0 million for the fourth quarter of 2015. For the full year, operating expenses were $173.9 million, compared to $143.5 million in 2015. Net loss was $35.6 million in the fourth quarter of 2016, or a $1.02 loss per share, and net loss for the full year was $113.2 million, or a $3.25 loss per share. At December 31, 2016, the company held approximately $143.0 million in cash, cash equivalents and marketable securities.

2017 Outlook

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 to $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

On February 22, 2017 Clovis Oncology, Inc. (NASDAQ:CLVS) reported financial results for the quarter and year ended December 31, 2016, and provided an update on the Company’s clinical development programs and regulatory outlook for 2017 (Press release, Clovis Oncology, FEB 22, 2017, View Source;p=RssLanding&cat=news&id=2248380 [SID1234517803]).

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"We are extremely pleased with the Rubraca launch to date; our commercial team hit the ground running and we are committed to the successful launch of this new therapeutic option for the treatment of advanced ovarian cancer," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "We are preparing for a potential approval in the EU in late 2017 or early 2018, and are aggressively building our European organization. We continue to anticipate the ARIEL3 read out in mid-2017, and we look forward to expanding the TRITON program into earlier line castrate-resistant prostate cancer. We will provide additional details on this study and other clinical development plans to develop rucaparib in other indications as well as in combination with an immuno-oncology agent over the course of this year."

Fourth Quarter and Year-End 2016 Financial Results

Clovis had $266.2 million in cash, cash equivalents and available-for-sale securities as of December 31, 2016. Cash used in operating activities was $54.7 million for the fourth quarter of 2016 and $266.7 million for the year ended December 31, 2016. Clovis had approximately 38.7 million shares of common stock outstanding as of December 31, 2016. In January 2017, the Company raised net proceeds of $221.2 million through an offering of 5.75 million shares of common stock.

Clovis reported a net loss for the fourth quarter of 2016 of $70.7 million, or ($1.83) per share, and $349.1 million or ($9.07) per share for the year ended December 31, 2016. The net loss for the fourth quarter of 2015 was $119.5 million or ($3.12) per share and $352.9 million or ($9.79) per share for the year ended December 31, 2015. Net loss for the fourth quarter of 2016 included share-based compensation expense of $10.1 million and $39.8 million for the full year 2016, respectively, compared to $10.9 million and $40.4 million for the comparable periods of 2015. Net product revenue for the quarter and the year was $78 thousand, following the approval and launch of Rubraca on December 19, 2016.

The net loss for the year ended December 31, 2016 includes a net expense non-cash impact of $50.6 million relating to the lucitanib product rights recorded in 2013 in connection with the Company’s acquisition of Ethical Oncology Science S.p.A. (EOS), comprised of a $104.5 million non-cash expense for the impairment of the intangible asset, a $25.5 million non-cash expense credit for the reduction in the fair value of the contingent purchase consideration liability and a $28.4 million related non-cash income tax benefit. The non-GAAP adjusted net loss excluding these items was $298.6 million or ($7.76) per share for the full year 2016.

Research and development expenses totaled $54.5 million for the fourth quarter of 2016, and $251.1 million for the full year 2016, compared to $76.0 million and $269.3 million, respectively, for the comparable periods in 2015. The decrease year over year is primarily due to decreased development activities for the rociletinib program and to a lesser extent, expenses related to the commercialization of Rubraca, which had been classified as research and development prior to FDA approval, partially offset by higher expenses related to the rucaparib program.

Selling, general and administrative expenses totaled $12.2 million for the fourth quarter of 2016, and $40.7 million for the full year 2016, compared to $8.2 million and $30.5 million for the comparable periods in 2015. The increase year over year is primarily due to higher legal costs; selling, general and administrative expenses related to the commercialization of Rubraca, which had been classified as research and development prior to FDA approval; and to a lesser extent, higher personnel costs.

Key Milestones and Objectives for Rucaparib

On December 19, 2016, the U.S. Food and Drug Administration (FDA) approved Rubraca (rucaparib) tablets as monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer, who have been treated with two or more chemotherapies, and selected for therapy based on an FDA-approved companion diagnostic for Rubraca. The indication for Rubraca is approved under the FDA’s accelerated approval program, and is based on objective response rate and duration of response results from two multicenter, single-arm, open-label clinical trials, Study 10 and ARIEL2 Parts 1 and 2. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. The ARIEL3 maintenance confirmatory study has completed enrollment and the ARIEL4 treatment confirmatory study is open for enrollment.

The ARIEL3 pivotal study is a randomized, double-blind study comparing the effects of rucaparib against placebo to evaluate whether rucaparib given as a maintenance therapy to platinum-sensitive patients can extend the period of time for which the disease is controlled after a positive outcome with platinum-based chemotherapy. Patients who have high-grade serous ovarian cancer and have had at least two prior lines of platinum-based chemotherapies are randomized to receive either placebo or rucaparib and the primary endpoint of the study is progression free survival, or PFS.

The primary efficacy analysis will evaluate, in a step-down process, BRCA-mutant patients, all patients with a homologous recombination deficiency, or HRD, signature (including BRCA and non-BRCA), followed by all patients. In addition, a pre-specified subgroup analysis is planned to evaluate patients with low volume or no residual disease at baseline, to determine the impact of disease burden on PFS. Importantly, this analysis will also identify the size of the population with meaningful disease still present after a partial response to second-line platinum therapy.

Target enrollment in ARIEL3 was completed during the second quarter of 2016. Data from ARIEL3 are expected mid-2017. Clovis has not yet been notified by the independent statistician that the required 70 percent of events in the mutant BRCA population has been reached, which will trigger the final analysis of the data. Pending positive data from ARIEL3, Clovis intends to follow up with a supplemental NDA for second-line maintenance therapy in women with ovarian cancer who have responded to platinum-based therapy.

The ARIEL4 confirmatory study, which is open for enrollment, is a Phase 3 multicenter, randomized study of rucaparib versus chemotherapy in relapsed ovarian cancer patients with BRCA mutations (inclusive of germline and/or somatic) who have failed two prior lines of therapy. The primary endpoint of the study is PFS.

Also during the quarter, the Company submitted an MAA for rucaparib to the European Medicines Agency for the same ovarian cancer treatment indication that was submitted to the U.S. FDA. Clovis anticipates an opinion from the Committee for Medicinal Products for Human Use (CHMP) in late 2017, and, pending a favorable opinion from CHMP, an approval would follow shortly thereafter.

In October, in support of the anticipated U.S. commercial launch of rucaparib, Clovis entered into a long-term manufacturing and supply agreement with Lonza, the manufacturer of the active pharmaceutical ingredient (API) for rucaparib. This new agreement for a dedicated manufacturing line is expected to provide security of supply and reduce cost of goods over time.

In February, Clovis entered into an agreement with Strata Oncology to accelerate patient identification and enrollment in the TRITON prostate cancer development program. The Strata trial is an observational study that provides no-cost tumor sequencing to patients at participating clinical sites, and under this agreement, match BRCA and ATM mutated advanced prostate cancer patients to Clovis’ TRITON studies. Strata has agreed not to provide similar matching services on behalf of any other Strata collaborator for any other metastatic castrate-resistant prostate cancer (mCRPC) clinical trial with respect to patients having those same genetic mutations.

Rucaparib Clinical Development

In addition to ARIEL3 and ARIEL4 mentioned above, Clovis has a robust clinical development program underway in multiple tumor types, including both Clovis-sponsored and investigator-initiated trials. Several clinical studies are open for enrollment or are anticipated to open during 2017:

The Clovis-sponsored TRITON2 (Trial of Rucaparib in Prostate Indications) study in mCRPC, a Phase 2 single-arm study enrolling patients with BRCA mutations and ATM mutations (both inclusive of germline and somatic) or other deleterious mutations in other homologous recombination (HR) repair genes and all patients will have progressed after receiving one line of taxane-based chemotherapy and one or two lines of androgen-receptor (AR) targeted therapy.
The Clovis-sponsored TRITON3 study, a Phase 3 comparative study in mCRPC enrolling BRCA mutant and ATM mutant (both inclusive of germline and somatic) patients who have progressed on AR-targeted therapy and who have not yet received chemotherapy in the castrate-resistant setting is also open for enrollment. TRITON3 will compare rucaparib to physician’s choice of AR-targeted therapy or chemotherapy in these patients.
The cooperative group-sponsored MITO-25 study evaluating rucaparib and bevacizumab in combination as a first-line maintenance therapy for advanced ovarian cancer; and
The investigator-initiated RUBY study in women with breast cancer whose tumors have a somatic BRCA mutation or homologous recombination deficient (HRD) signature other than a known germline BRCA mutation; and
The investigator-initiated PLATFORM study in gastroesophageal cancer in the first-line maintenance setting and
The Phase 1b combination study of Genentech’s cancer immunotherapy Tecentriq (atezolizumab; anti-PDL1) and rucaparib for the treatment of gynecological cancers, with a focus on ovarian cancer.

About Rubraca (rucaparib)

Rubraca is a PARP inhibitor indicated as monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer, who have been treated with two or more chemotherapies, and selected for therapy based on an FDA-approved companion diagnostic for Rubraca. The indication for Rubraca is approved under the FDA’s accelerated approval program based on objective response rate and duration of response, and is based on results from two multicenter, single-arm, open-label clinical trials. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Please visit rubraca.com for more information.

About Rucaparib

Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in ovarian cancer as well as several additional solid tumor indications. The MAA submission in Europe for an ovarian cancer treatment indication was submitted and accepted during the fourth quarter of 2016. Additionally, rucaparib is being developed as maintenance therapy for ovarian cancer in the ARIEL3 trial for patients with tumors with BRCA mutations and other DNA repair deficiencies beyond BRCA, as well as biomarker negative patients. Data from ARIEL3 are expected in mid-2017, which, pending positive data, is expected to be followed by the submission of a sNDA for a second line or later maintenance indication. Rucaparib is also being developed in patients with mutant BRCA tumors and other DNA repair deficiencies beyond BRCA – commonly referred to as homologous recombination deficiencies, or HRD. Studies open for enrollment or under consideration include prostate, breast, pancreatic, gastroesophageal, bladder and lung cancers. Clovis holds worldwide rights for rucaparib.