On February 6, 2018 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported that the first patient has been dosed in a phase 1 study evaluating the safety and tolerability of U3-1402, an investigational and potential first-in-class HER3-targeting antibody drug conjugate (ADC), in patients with metastatic or unresectable epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (C) whose disease has progressed while taking an EGFR tyrosine kinase inhibitor (TKI) (Press release, Daiichi Sankyo, FEB 6, 2018, View Source [SID1234523766]).

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Treatment with EGFR TKIs such as erlotinib, gefitinib, or afatinib is used as first-line therapy for metastatic EGFR-mutated NSCLC.1,2,3,4 However, patients eventually develop resistance to these treatments, typically experiencing disease progression within a year.1,2,3,4 More than half of these patients develop resistance with a secondary EGFR mutation called T790M, which may be treated with EGFR TKI osimertinib.1,2,3,4 Patients who experience disease progression following EGFR TKI treatment and who have tumors that lack the T790M mutation may be treated with chemotherapy, immunotherapy, or with investigational treatments.3,4

Expression of HER3, a member of the HER family of receptor tyrosine kinases, is believed to play a role in tumor growth and proliferation in many different types of cancer including NSCLC.5 Studies have shown that HER3 overexpression in lung cancer can also be associated with acquired resistance to other EGFR family targeted interventions such as TKIs and anti-EGFR antibody therapies.5 Patients with NSCLC with high levels of HER3 may face a significantly worse prognosis and decreased survival.5,6,7 Currently, there are no approved HER3-targeted therapies.

"While the treatment of metastatic EGFR-mutated NSCLC has significantly improved over the past decade, new treatments are needed that work to overcome resistance associated with current EGFR TKIs," said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo. "In this study, we are exploring whether the smart delivery of chemotherapy with U3-1402 to cancer cells that express HER3 – a known feature of resistance in pre-treated EGFR-mutated NSCLC – could become a new treatment strategy for these patients."

About the Study

The global, phase 1, open label, two-part study will enroll patients with metastatic or unresectable EGFR-mutated NSCLC whose disease has progressed while taking an EGFR TKI. This includes patients who experienced disease progression during treatment with erlotinib, gefitinib, or afatinib and whose tumors have tested negative for the T790M mutation and patients who experienced disease progression during treatment with osimertinib regardless of T790M status. The primary objectives of the study are to assess the safety and tolerability of U3-1402 and determine the recommended dose for the dose expansion part of the study. The secondary objectives are to characterize the pharmacokinetics of U3-1402 and to evaluate preliminary efficacy by measuring antitumor activity of U3-1402. The study is expected to enroll more than 60 patients at approximately 17 sites globally. For more information about the study, visit ClinicalTrials.gov.

About U3-1402

Part of the investigational ADC Franchise of the Daiichi Sankyo Cancer Enterprise, U3-1402 is an investigational and potential first-in-class ADC. ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy ("payload") to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells. Designed using Daiichi Sankyo’s proprietary ADC technology, U3-1402 is a smart chemotherapy comprised of a human anti-HER3 antibody attached to a novel topoisomerase I inhibitor payload by a tetrapeptide-based linker. It is designed to target and deliver chemotherapy inside cancer cells and reduce systemic exposure to the cytotoxic payload (or chemotherapy) compared to the way chemotherapy is commonly delivered.

U3-1402 is currently being evaluated in two phase 1 clinical studies including a phase 1/2 study for HER3-expressing metastatic or unresectable breast cancer and a phase 1 study for metastatic or unresectable EGFR-mutated NSCLC. U3-1402 is an investigational agent that has not been approved for any indication in any country. Safety and efficacy have not been established.

About Daiichi Sankyo Cancer Enterprise

The vision of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science Franchise, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA. Compounds in pivotal stage development include: DS-8201, an antibody drug conjugate (ADC) for HER2-expressing breast, gastric and other cancers; quizartinib, an oral selective FLT3 inhibitor, for newly-diagnosed and relapsed/refractory acute myeloid leukemia (AML) with FLT3-ITD mutations; and pexidartinib, an oral CSF-1R inhibitor, for tenosynovial giant cell tumor (TGCT). For more information, please visit: www.DSCancerEnterprise.com.

On February 6, 2018 Gilead Sciences, Inc. (Nasdaq: GILD) reported its results of operations for the fourth quarter and full year 2017 (Press release, Gilead Sciences, FEB 6, 2018, View Source [SID1234523758]). Total revenues for the fourth quarter of 2017 were $5.9 billion compared to $7.3 billion for the same period in 2016. Net loss for the fourth quarter of 2017 was $3.9 billion, or $2.96 loss per share, compared to net income of $3.1 billion, or $2.34 per diluted share for the same period in 2016. The net loss for the fourth quarter includes an estimated $5.5 billion charge related to the enactment of the Tax Cuts and Jobs Act (Tax Reform)(1). Non-GAAP net income for the fourth quarter of 2017 was $2.3 billion, or $1.78 per diluted share, compared to $3.6 billion, or $2.70 per diluted share for the same period in 2016. Non-GAAP net income excludes amounts related to acquisition-related, up-front collaboration, stock-based compensation and other expenses, and the impact of Tax Reform.

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Full year 2017 total revenues were $26.1 billion, compared to $30.4 billion for 2016. Net income for 2017 was $4.6 billion, or $3.51 per diluted share, compared to $13.5 billion, or $9.94 per diluted share for 2016. Non-GAAP net income for 2017 was $11.7 billion, or $8.84 per diluted share, compared to $15.7 billion, or $11.57 per diluted share for 2016.

Product Sales

Total product sales for the fourth quarter of 2017 were $5.8 billion, compared to $7.2 billion for the same period in 2016. Product sales for the fourth quarter of 2017 were $4.1 billion in the United States, $1.1 billion in Europe and $553 million in other locations. Product sales for the fourth quarter of 2016 were $4.9 billion in the United States, $1.4 billion in Europe and $870 million in other locations.
Total product sales during 2017 were $25.7 billion, compared to $30.0 billion in 2016. For 2017, product sales were $18.1 billion in the United States, $5.0 billion in Europe and $2.6 billion in other locations. For 2016, product sales were $19.3 billion in the United States, $6.1 billion in Europe and $4.6 billion in other locations.

Antiviral Product Sales
Antiviral product sales, which include sales of our HIV, chronic hepatitis B (HBV) and chronic hepatitis C (HCV) products, were $5.2 billion for the fourth quarter of 2017 compared to $6.6 billion for the same period in 2016. For 2017, antiviral product sales were $23.3 billion compared to $27.7 billion in 2016.
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HIV and HBV product sales for the fourth quarter of 2017 were $3.7 billion compared to $3.4 billion for the same period in 2016 and $14.2 billion for the full year 2017 compared to $12.9 billion in 2016. The increases were primarily driven by the continued uptake of our tenofovir alafenamide (TAF)-based products, Genvoya (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg), Descovy (emtricitabine 200 mg/tenofovir alafenamide 25 mg) and Odefsey (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg).
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HCV product sales, which consist of Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg), Sovaldi (sofosbuvir 400 mg), Epclusa (sofosbuvir 400 mg/velpatasvir 100 mg) and Vosevi (sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg), were $1.5 billion for the fourth quarter of 2017 compared to $3.2 billion for the same period in 2016 and $9.1 billion for the full year 2017 compared to $14.8 billion in 2016. The declines were across all major markets.

Other Product Sales
Other product sales, which include Letairis (ambrisentan), Ranexa (ranolazine) and AmBisome (amphotericin B for liposome injection), were $624 million for the fourth quarter of 2017 compared to $621 million for the same period in 2016. For 2017, other product sales were $2.3 billion compared to $2.2 billion in 2016.

For 2017 compared to 2016:
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R&D expenses decreased primarily due to the 2016 impacts of impairment charges related to IPR&D, ongoing milestone payments, up-front collaboration expenses related to Gilead’s license and collaboration agreement with Galapagos NV and Gilead’s purchase of Nimbus Apollo, Inc., partially offset by Gilead’s purchase of Cell Design Labs in 2017.
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Non-GAAP R&D expenses* decreased primarily due to the 2016 impact of ongoing milestone payments.
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SG&A expenses increased primarily due to acquisition-related costs associated with Gilead’s acquisition of Kite.
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Non-GAAP SG&A expenses* increased primarily due to higher branded prescription drug fee expense.

Provision for Income Taxes and Tax Reform
Provision for income taxes was $6.0 billion for the fourth quarter of 2017 compared to $821 million for the same period in 2016 and $8.9 billion for the full year 2017 compared to $3.6 billion in 2016. The increases were primarily due to an estimated charge of $5.5 billion from Tax Reform, which was enacted on December 22, 2017 and lowers U.S. corporate income tax rates as of January 1, 2018, implements a territorial tax system and imposes a repatriation tax on deemed repatriated earnings of foreign subsidiaries. This estimate is provisional and based on our initial analysis and current interpretation. Given the complexity of the legislation, anticipated guidance from the U.S. Treasury, and the potential for additional guidance from the Securities and Exchange Commission ("SEC") or the Financial Accounting Standards Board, this estimate may be adjusted during 2018.
Non-GAAP provision for income taxes excludes the estimated charge of $5.5 billion from Tax Reform. A reconciliation between GAAP and non-GAAP financial information is provided in the tables on pages 8, 9 and 10.

Cash, Cash Equivalents and Marketable Securities
As of December 31, 2017, Gilead had $36.7 billion of cash, cash equivalents and marketable securities compared to $32.4 billion as of December 31, 2016. During 2017, Gilead generated $11.9 billion in operating cash flow and in connection with the acquisition of Kite, Gilead issued $3.0 billion aggregate principal amount of senior unsecured notes and $6.0 billion aggregate principal amount of term loan facilities, of which $1.5 billion was repaid in December 2017. Additionally, Gilead paid cash dividends of $2.7 billion and utilized $954 million on stock repurchases.

Corporate Highlights
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Announced that Executive Chairman John C. Martin, PhD will transition from his current role of Executive Chairman to Chairman of the Board of Directors effective March 9, 2018.
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Announced the acquisition of Cell Design Labs, gaining new technology platforms that will enhance research and development efforts in cellular therapy.
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Announced the launch of the Gilead COMPASS (COMmitment to Partnership in Addressing HIV/AIDS in Southern States) Initiative, a 10-year, $100 million commitment to support organizations working to address the HIV/AIDS epidemic in the Southern United States.
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Announced the promotion of Alessandro Riva, MD, to Executive Vice President, Oncology Therapeutics, with responsibility for Gilead’s hematology and oncology programs, including cell therapy research and development.
Product & Pipeline Updates announced by Gilead during the Fourth Quarter of 2017 include:
HIV and Liver Diseases Programs
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Presented data at The Liver Meeting 2017 which included the announcement of:
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Results from a Phase 2, randomized, placebo-controlled trial evaluating two doses of GS-0976, an oral, investigational inhibitor of Acetyl-CoA carboxylase, in patients with nonalcoholic steatohepatitis (NASH). The data demonstrate that the higher dose of GS-0976 (20 mg taken orally once daily) when administered for 12 weeks was associated with statistically significant reductions in hepatic steatosis (buildup of fat in the liver) and a noninvasive marker of fibrosis compared to placebo.
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Results from an open-label Phase 2 study evaluating once-daily Harvoni for 12 weeks among HCV genotype 1 patients with severe renal impairment (creatinine clearance ≤ 30 mL/min). 100 percent of patients achieved a sustained virologic response 12 weeks after completing therapy (SVR12), including patients with compensated cirrhosis and those who had failed prior treatment.
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Results from an open-label Phase 2 study evaluating once-daily Epclusa for 12 weeks among 79 liver transplant patients with genotype 1-4 chronic HCV infection. Treatment with Epclusa resulted in an overall SVR12 rate of 96 percent, including patients with cirrhosis and prior treatment failure, and was well tolerated.
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Updated results from two Phase 3 studies demonstrating improved long-term bone and renal safety in HBV-infected patients 48-weeks after switching from Viread (tenofovir disoproxil fumarate 300mg) to Vemlidy (tenofovir alafenamide 25mg).

Announced detailed 48-week results from a Phase 3 study evaluating the efficacy and safety of switching virologically suppressed HIV-1 infected adult patients from a multi-tablet regimen containing a boosted protease inhibitor (bPI) to a fixed-dose combination of bictegravir (50 mg) (BIC), a novel investigational integrase strand transfer inhibitor, and emtricitabine/tenofovir alafenamide (200/25 mg) (FTC/TAF), a dual-NRTI backbone. In the ongoing study, BIC/FTC/TAF was found to be statistically non-inferior to regimens containing bPIs and demonstrated no treatment-emergent resistance at 48 weeks. The data were presented at IDWeek 2017.

Announced a new licensing agreement with the Medicines Patent Pool (MPP), a United Nations-backed public health organization, to expand access to BIC upon regulatory approval in the United States. Through this agreement, MPP can sub-license rights to BIC to generic drug companies in India, China and South Africa to manufacture therapies containing BIC for distribution in 116 low- and middle-income countries.

Oncology and Cell Therapy Programs

Announced updated results from the ongoing Phase 1/2 ZUMA-3 study of KTE-C19, a CD19 chimeric antigen receptor T (CAR T) cell therapy, which is investigational, for the treatment of adult patients with relapsed or refractory acute lymphoblastic leukemia (ALL). With a minimum of eight weeks of follow-up, 71 percent of ALL patients (n=17/24) who received a single infusion of KTE-C19 achieved complete tumor remission (complete remission (CR) or CR with incomplete hematological recovery). The ZUMA-3 study results were presented in an oral session at the Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper).

Announced long-term follow-up data from the ZUMA-1 study of Yescarta (axicabtagene ciloleucel) in patients with refractory large B-cell lymphoma. With a minimum follow-up of one year after a single infusion of Yescarta (median follow-up of 15.4 months), 42 percent of patients continued to respond to therapy, including 40 percent with a complete remission. Detailed results from this updated analysis were simultaneously presented at the Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper), and published in The New England Journal of Medicine.

Announced that U.S. Food and Drug Administration has granted regular approval to Yescarta, the first CAR T cell therapy for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma (transformed follicular lymphoma).

Non-GAAP Financial Information
The information presented in this document has been prepared by Gilead in accordance with U.S. generally accepted accounting principles (GAAP), unless otherwise noted as non-GAAP. Management believes non-GAAP information is useful for investors, when considered in conjunction with Gilead’s GAAP financial information, because management uses such information internally for its operating, budgeting and financial planning purposes. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of Gilead’s operating results as reported under GAAP. Non-GAAP measures may be defined and calculated differently by other companies in the same industry. A reconciliation between GAAP and non-GAAP financial information is provided in the tables on pages 8, 9, 10 and 11.

Conference Call
At 4:30 p.m. Eastern Time today, Gilead’s management will host a conference call and a simultaneous webcast to discuss results from its fourth quarter 2017 and full year 2017 as well as provide 2018 guidance and a general business update. To access the webcast live via the internet, please connect to the company’s website at www.gilead.com/investors 15 minutes prior to the conference call to ensure adequate time for any software download that may be needed to hear the webcast. Alternatively, please call (877) 359-9508 (U.S.) or (224) 357-2393 (international) and dial the conference ID 6478317 to access the call.

A replay of the webcast will be archived on the company’s website for one year, and a phone replay will be available approximately two hours following the call through February 8, 2018. To access the phone replay, please call (855) 859-2056 (U.S.) or (404) 537-3406 (international) and dial the conference ID 6478317.

On February 6, 2018 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that the following presentations by Company management at upcoming investor conferences will be webcast (Press release, ImmunoGen, FEB 6, 2018, View Source [SID1234523759]):

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Leerink Partners 7th Annual Global Healthcare Conference
February 15 at 3:30pm ET
RBC Capital Markets 2018 Global Healthcare Conference
February 21 at 2:35pm ET
Cowen and Company 38th Annual Health Care Conference
March 13 at 8:40am ET

A webcast of each presentation will be accessible through the Investors section of the Company’s website, www.immunogen.com. Following the live webcast, a replay will be available at the same location for approximately two weeks.

On February 6, 2018 LabCorp (or the Company) (NYSE: LH) reported results for the fourth quarter and year ended December 31, 2017, and provided 2018 guidance (Press release, LabCorp, FEB 6, 2018, View Source;p=RssLanding&cat=news&id=2330471 [SID1234523760]).

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"We achieved outstanding full year results, highlighted by revenue over $10 billion, adjusted EPS at the high end of our guidance range, and free cash flow in excess of $1.1 billion," said David P. King, chairman and CEO. "Our performance in the quarter demonstrated our multi-faceted growth platform, as our Diagnostics and Drug Development businesses each delivered excellent performance through a combination of strategic acquisitions, organic initiatives, and margin improvement. We are well positioned for another year of strong performance in 2018 driven by momentum in our businesses, expansion of our capabilities and talent base, broadened geographic presence, and delivery of innovative solutions that only LabCorp can offer."

Consolidated Results

Fourth Quarter Results

Net revenue for the quarter was $2.70 billion, an increase of 13.2% compared to $2.39 billion in the fourth quarter of 2016. The increase in net revenue was due to growth from acquisitions of 10.0%, organic growth (net revenue growth less revenue from acquisitions for the first twelve months after the close of each acquisition) of 2.6%, and the benefit from foreign currency translation of approximately 60 basis points.

Operating income for the quarter was $354.2 million, or 13.1% of net revenue, compared to $323.4 million, or 13.5%, in the fourth quarter of 2016. The increase in operating income was primarily due to acquisitions, organic revenue growth, and the Company’s LaunchPad business process improvement initiative. The decline in operating margin was primarily due to restructuring charges, special items, and amortization which together totaled $102.0 million in the quarter, compared to $64.4 million during the same period in 2016. Adjusted operating income (excluding amortization of $62.9 million, as well as restructuring charges and special items of $39.1 million) for the quarter was $456.2 million, or 16.9% of net revenue, compared to $387.8 million, or 16.2%, in the fourth quarter of 2016.

Net earnings in the quarter were $706.8 million, compared to $184.4 million in the fourth quarter of 2016. Diluted EPS were $6.81 in the quarter, compared to $1.75 in the same period in 2016. During the quarter, the Company recorded a net benefit of $519.0 million in net earnings, or $5.00 per diluted share, due to the implementation of the Tax Cuts and Jobs Act of 2017 (TCJA), which resulted in a favorable re-valuation of deferred taxes, partially offset by the deemed repatriation tax. Given the significant changes resulting from the TCJA, the estimated financial impact in the quarter is provisional and subject to further clarification, which could result in changes to these estimates during 2018.

Adjusted EPS (excluding tax reform, amortization, restructuring charges and special items) were $2.45 in the quarter, an increase of 14.0% compared to $2.15 in the fourth quarter of 2016.

Operating cash flow for the quarter was $564.0 million, compared to $448.9 million in the fourth quarter of 2016. The increase in operating cash flow was due to higher cash earnings and improved working capital. Capital expenditures totaled $96.1 million, compared to $74.3 million a year ago. As a result, free cash flow (operating cash flow less capital expenditures) was $467.9 million, compared to $374.6 million in the fourth quarter of 2016.

At the end of the quarter, the Company’s cash balance and total debt were $316.7 million and $6.8 billion, respectively. During the quarter, the Company invested $83.3 million in acquisitions, paid down $443.0 million of debt, and repurchased $40.0 million of stock representing approximately 0.3 million shares. The Company had $407.4 million of authorization remaining under its share repurchase program at the end of the quarter.

Full Year Results

Net revenue was $10.21 billion, an increase of 8.2% over last year’s $9.44 billion. The increase in net revenue was due to growth from acquisitions of 5.8%, and organic growth of 2.4%.

Operating income was $1.4 billion, or 13.4% of net revenue, compared to $1.3 billion, or 13.9%, in 2016. The increase in operating income was primarily due to acquisitions, organic revenue growth, and the LaunchPad business process improvement initiative, partially offset by higher personnel costs. The decline in operating margin was primarily due to higher amortization, restructuring charges, and special items. Adjusted operating income (excluding amortization of $216.5 million, as well as restructuring charges and special items of $150.7 million) for the year was $1.7 billion, or 17.0% of net revenue, compared to $1.6 billion, or 16.9%, last year.

Net earnings for 2017 were $1.3 billion, or $12.21 per diluted share, compared to $732.1 million, or $7.02 per diluted share, in 2016. As previously noted, the Company recorded a provisional net benefit of $519.0 million in net earnings in the fourth quarter, or $5.00 per diluted share, due to the implementation of the TCJA. Adjusted EPS (excluding tax reform, amortization, restructuring charges and special items) were $9.60, an increase of 8.7% compared to $8.83 in 2016.

Operating cash flow was $1.5 billion, compared to $1.2 billion in 2016, due to higher cash earnings and improved working capital. Capital expenditures totaled $312.9 million, compared to $278.9 million a year ago. As a result, free cash flow (operating cash flow less capital expenditures) was $1,146.5 million, compared to $897.0 million in 2016.

During the year, the Company invested approximately $1.9 billion in acquisitions, and repurchased $338.1 million of stock representing approximately 2.4 million shares.

The following segment results exclude amortization, restructuring charges, special items and unallocated corporate expenses.

Fourth Quarter Segment Results

LabCorp Diagnostics

Net revenue for the quarter was $1.82 billion, an increase of 8.6% over $1.67 billion in the fourth quarter of 2016. The increase in net revenue was driven by acquisitions, organic volume (measured by requisitions excluding those from acquisitions for the first twelve months after the close of each acquisition), and the benefit from foreign currency translation of approximately 30 basis points. Total volume (measured by requisitions) increased by 6.6%, of which organic volume was 2.9% and acquisition volume was 3.7%. Revenue per requisition increased by 1.8%.

Adjusted operating income (excluding amortization, restructuring charges and special items) for the quarter was $356.5 million, or 19.6% of net revenue, compared to $317.8 million, or 19.0%, in the fourth quarter of 2016. The increase in operating income and margin were primarily due to strong revenue growth and LaunchPad savings.

Covance Drug Development

Net revenue for the quarter was $886.1 million, an increase of 23.8% over $715.6 million in the fourth quarter of 2016. The increase was primarily due to the acquisition of Chiltern, as well as organic growth and the benefit from foreign currency translation of approximately 140 basis points.

Adjusted operating income (excluding amortization, restructuring charges and special items) for the quarter was $134.9 million, or 15.2% of net revenue, compared to $106.5 million, or 14.9%, in the fourth quarter of 2016. The increase in operating income and margin were primarily due to the acquisition of Chiltern, organic revenue growth, and LaunchPad savings, partially offset by higher personnel costs. The Company remains on track to deliver cost synergies from the integration of Chiltern of $30 million within three years of the acquisition.

Net orders and net book-to-bill during the trailing twelve months were $4.14 billion and 1.36, respectively. Backlog at the end of the quarter was $7.13 billion, and the Company expects approximately $2.8 billion of this backlog to convert into revenue in the next twelve months.

The Company commenced the LaunchPad initiative in Covance Drug Development in mid-2017, focused on right-sizing the business, re-engineering Covance’s drug development solutions, integrating new tools and technology, and sustainably enhancing the employee and customer experience. The Company expects the initiative to achieve additional net savings of $130 million over the three-year period ending in 2020.

Outlook for 2018

The following guidance includes the estimated impact from adoption of the new revenue recognition accounting standard (ASC 606) as of January 1, 2018, the implementation of the TCJA, and currently anticipated capital allocation. The following guidance also assumes foreign exchange rates effective as of December 31, 2017 for the full year. In addition, to support the comparison of year-on-year results, the Company has provided a preliminary reconciliation that restates revenue in 2017 to show the impact of the new revenue recognition accounting standard for illustrative purposes. This calculation will be finalized upon adoption in the first quarter of 2018 and the amounts are therefore subject to change.

Revenue growth of 9.5% to 11.5% over 2017 restated revenue of $10.42 billion, which includes the benefit of approximately 60 basis points of foreign currency translation and equates to constant currency revenue growth of 8.9% to 10.9%.
Revenue growth in LabCorp Diagnostics of 3.0% to 5.0% over 2017 restated revenue of $6.86 billion, which includes the negative impact of the Protecting Access to Medicare Act (PAMA) as well as the benefit of approximately 20 basis points of foreign currency translation. This outlook equates to constant currency revenue growth of 2.8% to 4.8%.
Revenue growth in Covance Drug Development of 20.0% to 24.0% over 2017 restated revenue of $3.56 billion, which includes the benefit of approximately 140 basis points of foreign currency translation and equates to constant currency revenue growth of 18.6% to 22.6%.
Adjusted EPS of $11.30 to $11.70, an increase of approximately 17.7% to 21.9% as compared to $9.60 in 2017. The expected growth in adjusted EPS includes the benefit of an assumed lower tax rate in 2018 of 25%, contributing approximately $1.30 in adjusted EPS over 2017.
Free cash flow (operating cash flow less capital expenditures) of $1.1 billion to $1.2 billion, compared to $1.1 billion in 2017.

Use of Adjusted Measures

The Company has provided in this press release and accompanying tables "adjusted" financial information that has not been prepared in accordance with GAAP, including Adjusted EPS, Adjusted Operating Income, Free Cash Flow, and certain segment information. The Company believes these adjusted measures are useful to investors as a supplement to, but not as a substitute for, GAAP measures, in evaluating the Company’s operational performance. The Company further believes that the use of these non-GAAP financial measures provides an additional tool for investors in evaluating operating results and trends, and growth and shareholder returns, as well as in comparing the Company’s financial results with the financial results of other companies. However, the Company notes that these adjusted measures may be different from and not directly comparable to the measures presented by other companies. Reconciliations of these non-GAAP measures to the most comparable GAAP measures are included in the tables accompanying this press release.

The Company today is furnishing a Current Report on Form 8-K that will include additional information on its business and operations. This information will also be available in the investor relations section of the Company’s website at www.labcorp.com. Analysts and investors are directed to the Current Report on Form 8-K and the website to review this supplemental information.

A conference call discussing LabCorp’s quarterly results will be held today at 9:00 a.m. Eastern Time and is available by dialing 844-634-1444 (615-247-0253 for international callers). The access code is 3587888. A telephone replay of the call will be available through February 20, 2018 and can be heard by dialing 855-859-2056 (404-537-3406 for international callers). The access code for the replay is 3587888. A live online broadcast of LabCorp’s quarterly conference call on February 6, 2018 will be available at View Source or at View Source beginning at 9:00 a.m. Eastern Time. This webcast will be archived and accessible through February 1, 2019.

On February 6, 2018 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, reported that its Chief Executive Officer, Philip Serlin, will present a company update at the 2018 BIO CEO & Investor Conference on Tuesday, February 13, 2018 at 9:30 am EST (Press release, BioLineRx, FEB 6, 2018, View Source;p=RssLanding&cat=news&id=2330476 [SID1234523741]). The conference will be held at the New York Marriott Marquis.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live webcast of the presentation will be available on BioLineRx’s website. A replay will be available one hour after the presentation ends and will be accessible for three months following the presentation.

Investors or potential partners attending the conference who wish to meet with BioLineRx management should contact the BIO Partnering Team at [email protected].