On July 27, 2016 OncoCyte Corporation (NYSE MKT:OCX), a developer of novel, non-invasive blood based tests for the early detection of cancer, and The Wistar Institute, an international biomedical research leader in cancer, immunology and infectious diseases, reported that research results for a lung cancer diagnostic test being developed by The Wistar Institute and OncoCyte under a license from Wistar have been accepted for an Original Investigation Slide Presentation at the prestigious American College of Chest Physician’s CHEST 2016 annual meeting, which will be held in Los Angeles this October (Press release, BioTime, JUL 27, 2016, View Source;p=RssLanding&cat=news&id=2188711 [SID:1234514058]).

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The Presentation "A Blood Based Non-Small Cell Lung Cancer Diagnostic" will be presented by Louise Showe, Ph.D., professor of Molecular and Cellular Oncogenesis Program at The Wistar Institute and lead scientist on the study. Dr. Showe will report on results of a study that was conducted at Wistar and analyzed 610 human blood samples. Preliminary study results were announced in April of this year. The study replicated a previous study that was carried out at Wistar, the results of which were presented by Wistar at the American Thoracic Society conference in May of 2015.

OncoCyte must now independently validate the current results in its own follow-up study. In this study the Company will examine samples that it is collecting and will analyze them using its own laboratory facility and equipment. OncoCyte anticipates the validation study will begin in August 2016 and will be completed during the fourth quarter of 2016.

If the validation study is successful, OncoCyte intends to implement its commercialization plans with respect to the lung cancer diagnostic test, including hiring a dedicated sales force, building out its commercial infrastructure, and moving towards completion of and obtaining CLIA certification for its own diagnostic laboratory. The Company plans to launch its lung cancer diagnostic test in the first half of 2017.

"The acceptance of the data for presentation at CHEST is another step in validating our approach to diagnosing lung cancer and bringing it closer to commercialization by OncoCyte," said Dr. Showe.

"CHEST’s acceptance of this presentation on the effectiveness of our non-invasive diagnostic for the early detection of lung cancer is a significant development for OncoCyte and Wistar," commented William Annett, Chief Executive Officer of OncoCyte. "Each year there are 160,000 deaths related to lung cancer, in part because there is no effective test to reliably diagnose lung cancer at an early enough stage. We believe that OncoCyte’s non-invasive lung cancer diagnostic could represent an important step forward for patients, doctors and payers by improving outcomes and lowering costs. We look forward to continuing the next steps in the product development process and to providing additional updates in the coming months."

On July 27, 2016 DNAtrix, a clinical stage biotechnology company developing virus-driven immunotherapies for cancer, reported that the European Medicines Agency (EMA) has granted PRIority MEdicines (PRIME) designation for DNX-2401 as a promising new treatment for recurrent glioblastoma (Press release, DNAtrix, JUL 27, 2016, View Source [SID1234525538]).

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The PRIME initiative was launched by the EMA in March of 2016 to accelerate the regulatory approval of breakthrough therapies that target an unmet medical need. By offering prompt interaction with Sponsors developing innovative therapies, the objective is to provide patients who have few treatment options with early access to priority medicines that could provide significant benefit.

DNX-2401 is a potent oncolytic adenovirus that targets and kills cancer cells, while leaving normal cells intact. Multiple clinical studies in patients with recurrent glioblastoma and gynecologic cancer have shown that DNX-2401 has a favorable safety profile, strong tumor-killing potential and can trigger an antitumor immune response.

"We are pleased and honored that the European Medicines Agency has recognized the potential of our oncolytic immunotherapy DNX-2401 to make a positive impact on glioblastoma," said Joanna Peterkin, M.D., M.S., Chief Medical Officer of DNAtrix. "We look forward to working with the EMA on this important development program for DNX-2401, with the goal of improving the quality of life of patients with brain tumors."

DNAtrix has multiple ongoing studies, including a multicenter Phase 2 clinical study evaluating DNX-2401 with the checkpoint inhibitor pembrolizumab in patients with recurrent glioblastoma. For more information about this study, refer to Clinicaltrials.gov (NCT02798406).
About DNX-2401 in Glioblastoma

DNX-2401 is an investigational oncolytic immunotherapy designed to treat cancer, with glioblastoma as the initial indication. Glioblastoma is the most aggressive form of brain cancer, which has a median survival of 15 months following a patient’s initial diagnosis. DNX-2401 sets off a chain reaction of tumor cell killing by selectively replicating within glioblastoma cells (but not normal cells), causing tumor destruction and further spread of the oncolytic virus to adjacent tumor cells. This process can also trigger an anti-tumor immune response. DNX-2401 is currently being investigated in several clinical studies and has been well tolerated in all settings. Compelling results from Phase 1 clinical studies in recurrent glioblastoma indicate that DNX-2401 can (1) replicate in human brain tumors for a period of weeks to months, (2) trigger immune cell infiltration into the tumor, (3) cause ongoing tumor destruction detectable by MRI and (4) induce durable responses to therapy. In these studies, patient survival has been prolonged in a subset of patients, including in those achieving a complete response.

On July 27, 2016 The Medicines Company (NASDAQ:MDCO) reported its business and financial results for the second quarter ended June 30, 2016 (Press release, Medicines Company, JUL 27, 2016, View Source;p=RssLanding&cat=news&id=2188751 [SID:1234514063]).

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During the second quarter of 2016, the Company delivered strong execution against its strategic objectives by driving further advancement of its four potential blockbuster development programs and taking actions that generated non-dilutive capital and strategic and operational flexibility to enable it to continue to unlock the value of these programs.

Key highlights included:

PRODUCT DEVELOPMENT

CARBAVANCE (meropenem-vaborbactam): Announced that Carbavance met both FDA and EMA pre-specified primary endpoints in the Phase 3 TANGO 1 clinical trial in patients with complicated urinary tract infections. Carbavance also demonstrated statistical superiority over piperacillin-tazobactam, with overall success in 98.4% of patients treated with Carbavance, using the FDA primary endpoint. Carbavance was well-tolerated in the trial. This follows the granting of Fast Track status for Carbavance by the Food and Drug Administration (FDA) in April 2016 and the designation of Carbavance as a Qualified Infectious Disease Product, as authorized under the GAIN Act, in 2013. Enrollment is continuing in the Phase 3 TANGO 2 clinical trial, comparing Carbavance’s safety, tolerability, and efficacy with best available therapy in patients with serious infections due to confirmed or suspected CRE. The Company expects to submit a New Drug Application to the FDA in early 2017.

PCSK9si (PCSK9 synthesis inhibitor): Announced completion of patient enrollment ahead of schedule in the Phase 2 ORION-1 clinical trial of PCSK9si, an investigational first-in-class RNA interference proprotein convertase subtilisin/kexin type 9 synthesis inhibitor. Interim three-month and six-month efficacy and safety data from patients in ORION-1 are expected to be available, analyzed and presented before the end of 2016.

MDCO-216: Completed enrollment of more than 100 of 120 total planned patients in the MILANO-PILOT study evaluating MDCO-216’s effects on atherosclerotic plaque burden. Pursuant to the Interim Statistical Analysis Plan governing monitoring by the Independent Data Monitoring Committee (IDMC), an interim safety and efficacy analysis is currently being performed for the first 40 patients who have completed the end of treatment. The interim analysis will be reviewed by the IDMC in August. The Company is blinded and firewalled from all clinical data during the IDMC’s evaluation. If there are no safety concerns that require further evaluation and if pre-defined efficacy criteria are met, the IDMC will provide efficacy data from the first 40 patients to the Company. In any event, the Company expects to provide an update on the MILANO-PILOT trial in August.

ABP-700: Completed Phase 1 clinical pharmacology, dosing and safety studies in more than 300 subjects, including ABP-700’s use with pre- and co-medications routinely given as part of procedural sedation and induction of general anesthesia. In June, the Company dosed the first patient in a Phase 2 clinical trial for procedural sedation. The trial is expected to enroll 75 patients undergoing elective colonoscopies at three sites in The Netherlands. In consultation with the FDA, the Company will perform an additional animal study to support the submission of an Investigational New Drug Application in the United States. We expect to report results from the Phase 2 trial before the end of 2016.

STRATEGIC ACTIONS

Generated non-dilutive capital by completing the sale of the Company’s non-core cardiovascular products (Cleviprex (clevidipine) injection emulsion, Kengreal (cangrelor), and rights to Argatroban for injection) to Chiesi for an initial payment of $264 million in cash plus the potential to receive up to $480 million in sales-based milestone payments.
Continued to implement the previously announced restructuring plan designed to reduce operating expenses and R&D by $65 million to $80 million annually.
Completed the offering and sale of $402.5 million aggregate principal amount of 2.75% convertible notes due 2023 and repurchased $220 million (approximately 80%) of the Company’s 2017 convertible notes.
Continued to build senior management depth with the addition of Tony Kingsley, President and Chief Operating Officer, to help oversee the day-to-day operations and lead the Company’s commercial activities.
"We continue our focus on saving lives, alleviating suffering, and improving the economic efficiency of healthcare, but our purpose has magnified with the scale of the problems we are addressing with our programs and the numbers of patients we can potentially touch," said Clive Meanwell, M.D., Ph.D., Chief Executive Officer of The Medicines Company. "Through our execution over the last three quarters we have put ourselves in a position to focus on these big problems with our four core clinical development projects. We expect the pace of our progress to continue through the rest of 2016 with important clinical milestones for PCSK9si, MDCO-216, Carbavance and ABP-700."

Second-Quarter 2016 Financial Summary from Continuing Operations

Worldwide net revenue was $54.7 million in the second quarter of 2016 compared to $74.5 million in the second quarter of 2015. Included in total net revenue for the second quarter of 2016 was $24.4 million of royalty revenues derived from the gross profit of authorized generic sales of Angiomax (bivalirudin) by Sandoz, Inc. Worldwide Angiomax/Angiox (bivalirudin) net product sales were $15.8 million in the second quarter of 2016 compared to $65.6 million in the second quarter of 2015, with net product sales in the United States decreasing to $12.8 million in the second quarter of 2016 from $60.5 million in the second quarter of 2015, driven by the loss of Angiomax exclusivity in July 2015. Other products, including Ionsys, Minocin for Injection, and Orbactiv, along with the recently-divested non-core cardiovascular products, recorded sales of $14.5 million in the second quarter of 2016 compared to $8.9 million in the second quarter of 2015.

The sale of the Company’s non-core cardiovascular products resulted in a gain of $288.3 million, which was recorded in the second quarter of 2016.

Net income from continuing operations in the second quarter of 2016 was $181.8 million, or $2.51 per share, compared to net loss from continuing operations of $67.4 million, or $1.02 per share, in the second quarter of 2015. Adjusted net loss(1) from continuing operations in the second quarter of 2016 was $43.0 million, or $0.62(1) per share, compared to $45.2 million, or $0.69(1) per share, in the second quarter of 2015.

Second-Quarter 2016 Financial Summary from Discontinued Operations

In the first quarter of 2016, the Company completed the sale of its hemostasis products. Net income from discontinued operations in the second quarter of 2016 was $0.6 million, or $0.01 per share, compared to $20.9 million, or $0.31 per share, in the second quarter of 2015.

First-Half 2016 Financial Summary from Continuing Operations

Worldwide net revenue was $105.0 million in the first half of 2016 compared to $184.6 million in the first half of 2015. Included in total net revenue in the first half of 2016 was $43.3 million of royalty revenues derived from the gross profit of authorized generic sales of Angiomax (bivalirudin) by Sandoz, Inc. Worldwide Angiomax/Angiox(bivalirudin) net product sales were $32.7 million in the first half of 2016 compared to $166.3 million in the first half of 2015, with net product sales in the United States decreasing to $26.0 million in the first half of 2016 from $155.6 million in the first half of 2015, driven by the loss of Angiomax exclusivity in July 2015. Other products, including Ionsys, Minocin for Injection, and Orbactiv, along with the recently-divested non-core cardiovascular products, recorded sales of $29.0 million in the first half of 2016 compared to $18.3 million in the first half of 2015.

The sale of the Company’s non-core cardiovascular products resulted in a gain of $288.3 million, which was recorded in the second quarter of 2016.

Net income from continuing operations in the first half of 2016 was $91.5 million, or $1.27 per share, compared to net loss from continuing operations of $63.1 million, or $0.96 per share, in the first half of 2015. Adjusted net loss(1) from continuing operations in the first half of 2016 was $114.1 million, or $1.64(1) per share, compared to $44.8 million, or $0.68(1) per share in the first half of 2015.

First-Half 2016 Financial Summary from Discontinued Operations

Net loss from discontinued operations in the first half of 2016 was $1.5 million, or $0.02 per share, compared to net income from discontinued operations of $21.5 million, or $0.33 per share, in the first half of 2015.

(1)
Adjusted net loss and adjusted loss per share from continuing operations are non-GAAP financial performance measures with no standardized definitions under U.S. GAAP. For further information and a detailed reconciliation, refer to the Non-GAAP Financial Performance Measures and Reconciliations of GAAP to Adjusted Net Loss and Adjusted Loss per Share sections of this release for explanations of the amounts excluded and included to arrive at adjusted net loss and adjusted loss per share amounts.
At June 30, 2016, the Company had $644 million in cash and investments compared to $373 million at the end of 2015.

On July 27, 2016 Laboratory Corporation of America Holdings (LabCorp) (NYSE: LH) reported results for the quarter ended June 30, 2016 (Press release, LabCorp, JUL 27, 2016, View Source;p=RssLanding&cat=news&id=2188731 [SID:1234514065]).

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"Continued strong revenue growth and double-digit adjusted EPS growth demonstrate the soundness of our strategy," said David P. King, chairman and chief executive officer. "Our results reflect our customers’ growing enthusiasm for our differentiated offering as we improve health and improve lives around the globe by delivering world class diagnostics, bringing innovative medicines to patients faster and changing the way care is provided."

Consolidated Results

Second Quarter Results

Net revenue for the quarter was $2.38 billion, an increase of 7.4% over last year’s $2.22 billion. The increase in net revenue was primarily due to solid organic growth in both segments and tuck-in acquisitions, partially offset by the negative impact of foreign currency translation. Organic revenue growth in the quarter, excluding currency, was 6.4%.

Operating income for the quarter was $366.9 million, compared to $323.3 million in the second quarter of 2015. The Company recorded restructuring charges and special items of $14.5 million in the quarter, compared to $23.1 million during the same period in 2015. Adjusted operating income (excluding amortization of $45.3 million, restructuring and special items) for the quarter was $426.7 million, or 17.9% of net revenue, compared to $391.0 million, or 17.6%, in the second quarter of 2015. The increase in adjusted operating income and margin was primarily due to strong revenue growth, partially offset by personnel costs.

Net earnings in the quarter were $198.2 million, or $1.91 per diluted share, compared to $169.8 million, or $1.66 per diluted share, last year. Adjusted EPS (excluding amortization, restructuring and special items) were $2.31 in the quarter, an increase of 10.5% compared to $2.09 in the second quarter of 2015.

Operating cash flow for the quarter was $343.6 million, compared to $396.7 million last year. The decrease in operating cash flow was primarily due to greater working capital requirements, partially offset by increased earnings. Capital expenditures totaled $67.0 million, compared to $69.1 million in the second quarter of 2015. As a result, free cash flow (operating cash flow less capital expenditures) was $276.6 million, compared to $327.6 million in the second quarter of 2015.

At the end of the quarter, the Company’s cash balance and total debt were $639.6 million and $6.1 billion, respectively. During the quarter, the Company invested $50.8 million in tuck-in acquisitions and paid down $338.7 million of debt.

Year-To-Date Results

The following year-to-date consolidated results of the Company include Covance as of February 19, 2015; prior to February 19, 2015, these consolidated results exclude Covance.

Net revenue was $4.68 billion, an increase of 17.2% over last year’s $3.99 billion. The increase was primarily due to the inclusion of Covance’s financial results for the entire first half of the year as well as solid organic growth in both segments and tuck-in acquisitions.

Operating income was $668.8 million, compared to $455.7 million in the first half of 2015. The Company recorded restructuring charges and special items of $43.8 million in the first half of the year, compared to $161.8 million during the same period in 2015. Adjusted operating income (excluding amortization of $89.6 million, restructuring and special items) was $802.2 million, or 17.2% of net revenue, compared to $693.2 million, or 17.4%, in the first half of 2015. The increase in adjusted operating income was primarily due to strong revenue growth, partially offset by personnel costs. The decline in margin was due to the mix impact from the inclusion of Covance’s financial results for the entire first half of the year.

Net earnings in the first half of 2016 were $358.4 million, or $3.46 per diluted share, compared to $172.9 million, or $1.76 per diluted share, last year. Adjusted EPS (excluding amortization, restructuring and special items) were $4.33, compared to $3.85 in the first half of 2015.

Operating cash flow was $466.6 million, compared to $309.8 million in the first half of 2015. The Company’s operating cash flow was negatively impacted by $153.5 million last year due to non-recurring items relating to the acquisition of Covance. Excluding these items, operating cash flow was $463.3 million last year. Capital expenditures totaled $138.4 million, compared to $102.9 million in the first half of 2015. As a result, free cash flow (operating cash flow less capital expenditures) was $328.2 million, compared to $206.9 million in the first half of 2015. Excluding non-recurring items, free cash flow was $360.4 million last year.

***

The following segment results exclude amortization, restructuring, special items and unallocated corporate expenses. Reconciliations of segment results to historically reported results are included in the Condensed Pro Forma Segment Information tables and notes.

Segment Results

LabCorp Diagnostics

Net revenue for the quarter was $1.66 billion, an increase of 5.4% over last year’s $1.58 billion. The increase in net revenue was the result of organic volume growth (measured by requisitions), price, mix and tuck-in acquisitions, partially offset by the negative impact of foreign currency translation of 0.3%. Total volume (measured by requisitions) increased by 2.1% (organic volume of 1.2% and acquisition volume of 0.9%). Revenue per requisition increased by 3.5%.

Adjusted operating income (excluding amortization, restructuring and special items) for the quarter was $356.5 million, or 21.5% of net revenue, compared to $337.0 million, or 21.4%, in the second quarter of 2015. The increase was primarily due to price, mix, organic volume, tuck-in acquisitions and the Company’s LaunchPad business process improvement initiative, partially offset by personnel costs. LaunchPad remains on track to deliver net savings of $150 million through the three-year period ending in 2017.

Covance Drug Development

Net revenue for the quarter was $722.4 million, an increase of 12.2% over last year’s $643.7 million. The increase in net revenue was primarily due to broad-based demand, partially offset by the negative impact of foreign currency translation of approximately 70 basis points. Excluding the impact from currency and the expiration of the Sanofi site support agreement, net revenue increased 16.4% year over year.

Adjusted operating income (excluding amortization, restructuring and special items) was $107.7 million, or 14.9% of net revenue, compared to $89.9 million, or 14.0%, in the second quarter of 2015. The increase was primarily due to strong revenue growth and cost synergies, partially offset by the expiration of the Sanofi site support agreement and personnel costs. The Company remains on track to deliver cost synergies of $100 million related to the acquisition of Covance through the three-year period ending in 2017.

During the quarter, net orders (gross orders less cancellations and reductions) were $818 million, representing a net book-to-bill of 1.13, and a trailing twelve month net book-to-bill of 1.17.

Outlook for 2016

The following updated guidance assumes foreign exchange rates effective as of June 30, 2016 for the remainder of the year:

Net revenue growth of 9.5% to 10.5% over 2015 net revenue of $8.51 billion, which includes the impact from approximately 50 basis points of negative currency. This is an increase from prior guidance of 8.5% to 10.5%, which included approximately 40 basis points of negative currency.
Net revenue growth in LabCorp Diagnostics of 4.5% to 5.5% over 2015 pro forma revenue of $6.21 billion, which includes the impact from approximately 10 basis points of negative currency. This is an increase from prior guidance of 4.0% to 5.5%, which included approximately 20 basis points of negative currency.
Net revenue growth in Covance Drug Development of 7.0% to 9.0% over 2015 pro forma revenue of $2.63 billion, which includes the impact from approximately 110 basis points of negative currency. This is an increase from prior guidance of 6.0% to 9.0%, which included approximately 50 basis points of negative currency. Excluding the impact from currency and the expiration of the Sanofi site support agreement, net revenue is expected to increase approximately 11% to 13%.
Adjusted EPS of $8.60 to $8.95, versus prior guidance of $8.55 to $8.95, and as compared to $7.91 last year.
Free cash flow (operating cash flow less capital expenditures) of $900 million to $950 million, an increase of approximately 24% to 31% over the prior year, unchanged from prior guidance.
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, and Free Cash Flow. 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 its Current Report on Form 8-K that will include additional information on its business and operations. This information will also be available on 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 43356831. A telephone replay of the call will be available through August 3, 2016 and can be heard by dialing 855-859-2056 (404-537-3406 for international callers). The access code for the replay is 43356831.

On July 26, 2016 BIND Therapeutics, Inc. (NASDAQ: BIND), a biotechnology company developing targeted and programmable therapeutics called ACCURINS, reported that Pfizer Inc. (NYSE: PFE) prevailed at a Section 363 auction to purchase substantially all of BIND’s assets (Press release, BIND Therapeutics, JUL 26, 2016, View Source [SID1234556287]). The winning bid of $40 million, subject to U.S. Bankruptcy Court approval for which a hearing is scheduled to take place on July 27, 2016, was selected as the highest and best bid. NanoCarrier Co., Ltd. has been selected as the back-up bidder. The Company plans to disclose additional terms of its agreement with Pfizer upon Court approval.

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BIND initiated voluntary Chapter 11 bankruptcy protection on May 1, 2016 and conducted a sale of assets, pursuant to Section 363 of the Bankruptcy Code, during an auction held on July 25 and 26, 2016.