On July 28, 2015 Laboratory Corporation of America Holdings (LabCorp or the "Company") (NYSE: LH) reported results for the quarter ended June 30, 2015 (Press release, LabCorp, JUL 28, 2015, View Source;p=RssLanding&cat=news&id=2071567 [SID:1234506723]).

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Consolidated Results

Second Quarter Results

Net revenue for the quarter was $2.22 billion, an increase of 46.3% over last year’s $1.52 billion. The acquisition of Covance contributed $620.8 million in net revenue during the quarter, driving 40.9% year over year net revenue growth. The remainder of the increase of $81.5 million, or 5.4%, was primarily due to strong organic volume growth and tuck-in acquisitions, partially offset by currency. Organic revenue growth in the quarter, excluding currency, was 5.4%, of which Beacon LBS, the Company’s technology-enabled solution providing point-of-care decision support, contributed 1.1%.

Operating income for the quarter was $321.3 million, compared to $246.7 million in the second quarter of 2014. The Company recorded restructuring charges and special items of $23.1 million during the second quarter of 2015, compared to $6.7 million during the same period in 2014. Adjusted operating income (excluding amortization of $46.6 million, restructuring and special items) for the quarter was $391.0 million, or 17.6% of net revenue, compared to $275.4 million, or 18.2%, in the second quarter of 2014. The increase in adjusted operating income was due to the Covance acquisition, organic volume growth and productivity, partially offset by currency.

The Company recorded net earnings in the quarter of $168.4 million, or $1.64 per diluted share, compared to $141.3 million, or $1.64 per diluted share, last year. Adjusted EPS (excluding amortization, restructuring and special items) were $2.09 in the quarter, compared to $1.84 in the second quarter of 2014.

"We are extremely pleased with our results this quarter, in which we began to see the power of our combined businesses," said David P. King, Chairman and Chief Executive Officer. "We delivered impressive growth, as well as record revenue, earnings and free cash flow to our shareholders. We remain focused on executing our long-term growth strategy, and delivering on our mission of improving health and improving lives."

Operating cash flow for the second quarter was $396.7 million, compared to $207.4 million in the second quarter of 2014. The increase in operating cash flow was due to the acquisition of Covance as well as improved earnings and working capital. Capital expenditures totaled $69.1 million, compared to $48.1 million in the second quarter of 2014. As a result, free cash flow (operating cash flow less capital expenditures) was $327.6 million, compared to $159.3 million in the second quarter of 2014.

At the end of the quarter, the Company’s cash balance and total debt were $619.0 million and $6.8 billion, respectively. During the quarter, the Company invested $62.2 million in tuck-in acquisitions and paid down $145.0 million of debt. The Company’s liquidity at the end of the quarter was approximately $1.6 billion, consisting of cash and available credit.

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 $3.99 billion, an increase of 35.4% over last year’s $2.95 billion. The acquisition of Covance contributed $888.0 million from the date of closing on February 19, 2015, driving 30.1% year over year net revenue growth. The remainder of the increase of $155.9 million, or 5.3%, was due to strong organic volume growth and tuck-in acquisitions, partially offset by price, mix and currency. Organic revenue growth in the first half of the year, excluding currency, was 5.2%, of which Beacon LBS contributed 0.5%.

Operating income was $452.4 million, compared to $450.0 million in the first half of 2014. The Company recorded $161.8 million in restructuring charges and special items (costs associated with the acquisition of Covance and Project LaunchPad) during the first half of 2015, compared to $14.3 million during the same period in 2014. Adjusted operating income (excluding amortization of $79.0 million, restructuring and special items) was $693.2 million, or 17.4% of net revenue, compared to $507.3 million, or 17.2%, in the first half of 2014. The increase in adjusted operating income was due to the acquisition of Covance, organic volume growth and productivity gains, partially offset by price, mix and currency.

The Company’s earnings were reduced by restructuring and special items of $214.4 million ($161.8 million impacted operating income and $52.6 million impacted interest expense), or $154.8 million after-tax. As a result, the Company recorded net earnings in the first half of 2015 of $169.7 million, or $1.73 per diluted share, compared to $254.4 million, or $2.94 per diluted share, last year. Adjusted EPS (excluding amortization, restructuring and special items) were $3.85, compared to $3.35 in the first half of 2014.

Operating cash flow for the first half of 2015 was $309.8 million, compared to $349.7 million in the first half of 2014, as the Company’s operating cash flow was negatively impacted by $153.5 million in non-recurring items relating to the acquisition of Covance. Excluding these items, operating cash flow was $463.3 million, with the year-on-year increase driven by improved earnings, partially offset by seasonal working capital requirements. Capital expenditures totaled $102.9 million, compared to $104.6 million in the first half of 2014. As a result, free cash flow (operating cash flow less capital expenditures) was $206.9 million, compared to $245.1 million in the first half of 2014. Excluding non-recurring items, free cash flow was $360.4 million during the first half of 2015.

***

The following segment results are presented on a pro forma basis for all periods as if the acquisition of Covance closed on January 1, 2014 and 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 $1.58 billion, an increase of 5.4% over net revenue of $1.49 billion for the second quarter of 2014. The increase in net revenue was the result of organic volume growth, measured by requisitions, Beacon LBS and tuck-in acquisitions, partially offset by currency. The increase in net revenue of 5.4% includes the benefit from Beacon LBS of 1.1%, and unfavorable foreign currency translation of 0.7%. Total volume (measured by requisitions) increased by 4.7% (organic volume of 4.3% and acquisition volume of 0.4%). Revenue per requisition increased by 0.2%.

Adjusted operating income (excluding amortization, restructuring and special items) for the quarter was $347.1 million, or 22.0% of net revenue, compared to adjusted operating income of $308.9 million, or 20.7% of net revenue, in the second quarter of 2014. The increase was primarily due to strong volume growth and productivity. Improvement in productivity was driven, in part, by Project LaunchPad, the Company’s enterprise-wide business process improvement initiative. The Company is on track to deliver approximately $50 million of net savings in 2015 through Project LaunchPad.

Covance Drug Development

Net revenue for the quarter was $643.7 million, a decrease of 2.7% from revenue of $661.3 million for the second quarter of 2014. The strengthening U.S. Dollar negatively impacted year-over-year revenue growth by approximately 450 basis points. Excluding currency, net revenue increased 1.8% year-over-year, on increased volume, partially offset by mix.

Adjusted operating income (excluding amortization, restructuring and special items) was $89.9 million, or 14.0% of net revenue, compared to adjusted operating income of $84.7 million, or 12.8% of net revenue, in the second quarter of 2014. The increase was primarily due to higher volume, cost synergies and lower depreciation expense, partially offset by the impact of currency and mix. The Company is on track to deliver acquisition-related cost synergies in 2015 of approximately $35 million.

Net orders (gross orders less cancellations and reductions) in the quarter were $737 million, representing a net book-to-bill of 1.15. Backlog at June 30, 2015 was approximately $6.6 billion.

Outlook for 2015

The Company’s updated guidance for 2015 includes the following:

Net revenue growth (assuming foreign exchange rates effective as of June 30, 2015) of 40% to 42%, after the impact from approximately 190 basis points of negative currency. Net revenue growth in LabCorp Diagnostics of 3.5% to 5.5%, after the impact from approximately 70 basis points of negative currency. The change in net revenue in Covance Drug Development is expected to be -1.5% to 0.5% versus full year 2014 revenue after the impact of approximately 320 basis points of negative currency.

Adjusted EPS of $7.75 to $8.00, versus prior guidance of $7.55 to $7.90, and as compared to $6.80 last year.
Operating cash flow of $990 million to $1,015 million, capital expenditures of $270 million to $295 million, and free cash flow of $695 million to $745 million. The Company expects free cash flow in 2015 to be negatively impacted by approximately $120 million of net non-recurring items related to the Covance acquisition. Excluding these items, the Company expects free cash flow to be $815 million to $865 million versus $536 million last year.
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 relation’s 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.

On July 28, 2015 Merck (NYSE:MRK), known as MSD outside the United States and Canada, reported financial results for the second quarter of 2015 (Press release, Merck & Co, JUL 28, 2015, View Source [SID:1234506724]).

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Commentary from Chairman and Chief Executive Officer Kenneth C. Frazier

"We’re investing resources to grow our strongest brands and to support the most promising assets in our pipeline, while at the same time lowering our cost base and delivering operating leverage."

"We’ve made significant progress this quarter in two of our most important assets, the KEYTRUDA and hepatitis C programs, and will be fully prepared to take advantage of these potentially breakthrough opportunities."

"We’re witnessing the introduction of breakthrough therapies for some of the most difficult-to-treat diseases. Merck’s late-stage pipeline and ongoing launches reflect scientific and therapeutic progress with the potential to provide significant value to patients and society."

Select Business Highlights

Worldwide sales were $9.8 billion for the second quarter of 2015, a decrease of 11 percent compared with the second quarter of 2014, including a 7 percent negative impact from foreign exchange and a 7 percent net unfavorable impact resulting from the divestiture of the Consumer Care business and select products, partially offset by the acquisition of Cubist Pharmaceuticals, Inc. (Cubist).

The following table reflects sales of the company’s top pharmaceutical products, as well as total sales of Animal Health and Consumer Care products.

Commercial and Pipeline Highlights

During the second quarter of 2015, Merck continued to advance its pipeline while also focusing on the ongoing launches of KEYTRUDA (pembrolizumab), its anti-PD-1 therapy, for the treatment of advanced melanoma in patients whose disease has progressed after other therapies; BELSOMRA (suvorexant) for the treatment of insomnia; and ZERBAXA (ceftolozane and tazobactam), a combination product for the treatment of certain serious bacterial infections in adults.

The company accelerated its KEYTRUDA clinical development program.

The European Commission approved KEYTRUDA last week at a dose of 2 mg/kg every three weeks for the treatment of advanced (unresectable or metastatic) melanoma in adults, allowing marketing of KEYTRUDA in all 28 European Union member states.
The U.S. Food and Drug Administration (FDA) accepted for review the supplemental Biologics License Application (sBLA) for KEYTRUDA for the treatment of patients with advanced non-small cell lung cancer whose disease has progressed on or after platinum-containing chemotherapy and an FDA-approved therapy for EGFR or ALK genomic tumor aberrations, if present. The FDA granted Priority Review with a PDUFA action date of Oct. 2, 2015; the sBLA will be reviewed under the FDA’s Accelerated Approval program.

At the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in June, data sets were presented investigating the use of KEYTRUDA in advanced head and neck cancer (KEYNOTE-012) and in multiple difficult-to-treat cancers, including advanced small cell lung cancer, esophageal cancer and ovarian cancer (KEYNOTE-028). Additionally, data were presented and simultaneously published in The New England Journal of Medicine suggesting that the presence of DNA repair mutations in colorectal cancer cells is associated with favorable responses to KEYTRUDA.

The clinical development program for the treatment of chronic hepatitis C virus (HCV) infection made substantial progress in the second quarter of 2015.

As announced earlier today, the FDA has accepted for review the New Drug Application (NDA) for grazoprevir/elbasvir, an investigational once-daily, single tablet combination therapy for the treatment of adult patients infected with chronic HCV genotypes (GT) 1, 4 or 6. The FDA granted Priority Review with a PDUFA action date of Jan. 28, 2016.
Last week the European Medicines Agency (EMA) accepted for review the company’s marketing authorization application (MAA) for grazoprevir/elbasvir for the treatment of adult patients infected with chronic HCV GT 1, 3, 4 or 6. The EMA said it will initiate a review of the MAA under accelerated assessment timelines.

Results from the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) of JANUVIA (sitagliptin), a medicine that helps lower blood sugar levels in adults with type 2 diabetes, were presented in June at the 75th Scientific Sessions of the American Diabetes Association and simultaneously published online in The New England Journal of Medicine. The study found that, added to usual care, treatment with JANUVIA did not increase the risk of major adverse cardiovascular events in the primary composite endpoint, or hospitalization for heart failure, compared to placebo.

The FDA has accepted the resubmission of the NDA for sugammadex injection, an investigational medicine for the reversal of neuromuscular blockade induced by rocuronium or vecuronium, with a PDUFA action date of Dec. 19, 2015. Sugammadex injection is marketed as BRIDION in more than 60 countries.

The FDA has extended its planned review timeline of the Biologics License Application for V419, the investigational pediatric hexavalent combination vaccine, DTaP5-IPV-Hib-HepB, which is being developed and, if approved, will be commercialized through a partnership of Merck and Sanofi Pasteur. The FDA has not requested additional clinical studies for licensure.

Pharmaceutical Revenue Performance

Second-quarter pharmaceutical sales declined 6 percent to $8.6 billion, including a 9 percent negative impact from foreign exchange. Excluding the impact of exchange, growth was driven by sales in the core therapeutic areas of hospital acute care, oncology and diabetes. The increase in hospital acute care was driven by the addition of the Cubist portfolio and sales growth of inline brands. Growth in oncology reflects sales of $110 million for KEYTRUDA. Growth in diabetes primarily reflects higher sales in the United States, Europe and emerging markets.

Second-quarter pharmaceutical sales reflect declines in the cardiovascular portfolio of ZETIA (ezetimibe) and VYTORIN (ezetimibe/simvastatin), medicines for lowering LDL cholesterol, primarily due to loss of exclusivity of ZETIA in Canada (where it is marketed as EZETROL) and volume declines of both products in the United States, as well as lower sales of REMICADE (infliximab), a treatment for inflammatory diseases, due to loss of exclusivity in Europe. Pharmaceutical sales also reflect declines in the HCV portfolio of VICTRELIS (boceprevir) and PEGINTRON (peginterferon alfa-2b), as well as for ISENTRESS (raltegravir), an HIV integrase inhibitor for use in combination with other antiretroviral agents for the treatment of HIV-1 infection. The decline for ISENTRESS was due to timing of tender purchases in the emerging markets and volume declines in the United States.

Animal Health Revenue Performance

Animal Health sales totaled $840 million for the second quarter of 2015, a decrease of 4 percent compared with the second quarter of 2014, including a 14 percent negative impact from foreign exchange. Excluding the impact of exchange, growth was primarily driven by an increase in sales of companion animal and swine products, including continued strong growth from BRAVECTO (fluralaner), a chewable tablet that kills fleas and ticks in dogs for up to 12 weeks.

Other Revenue Performance

Other revenues – primarily comprising alliance revenue, miscellaneous corporate revenues and third-party manufacturing sales – decreased 3 percent to $381 million compared to the second quarter of 2014. The decrease was driven primarily by the loss of revenue from AstraZeneca recorded by Merck, which was $316 million in the second quarter of 2014, partially offset by higher third-party manufacturing sales.

Second-Quarter 2015 Expense and Other Information

The costs detailed below totaled $8.2 billion on a GAAP basis during the second quarter of 2015 and include $1.8 billion of acquisition- and divestiture-related costs and restructuring costs.

The gross margin was 61.6 percent for the second quarter of 2015 compared to 55.2 percent for the second quarter of 2014, reflecting 13.8 and 17.4 unfavorable percentage point impacts, respectively, from the acquisition- and divestiture-related costs and restructuring costs noted above. The increase in non-GAAP gross margin was driven by lower inventory write-offs and foreign exchange.

Marketing and administrative expenses, on a non-GAAP basis, were $2.5 billion in the second quarter of 2015, a decrease from $2.9 billion in the same period of 2014, which was primarily driven by the sale of the Consumer Care business, the favorable impact of foreign exchange and declines in direct selling costs.

Research and development (R&D) expenses, on a non-GAAP basis, were $1.6 billion in the second quarter of 2015, a 2 percent decrease compared to the second quarter of 2014.

Other (income) expense, net, was $739 million of expense in the second quarter of 2015 compared to $650 million of income in the second quarter of 2014. The second quarter of 2015 includes foreign exchange losses of $715 million related to the revaluation of the company’s net monetary assets in Venezuela. The second quarter of 2014 includes a $741 million gain recorded in connection with AstraZeneca’s option exercise.

The GAAP effective tax rate of 14.7 percent for the second quarter of 2015 reflects the impacts of acquisition- and divestiture-related costs and restructuring costs, as well as the favorable impact of a net benefit of $370 million related to the settlement of certain federal income tax issues and the unfavorable impact of foreign exchange losses related to Venezuela for which no tax benefit was recorded. The non-GAAP effective tax rate, which excludes these items, was 26.0 percent for the second quarter of 2015.

Financial Outlook

Merck has narrowed and raised its full-year 2015 non-GAAP EPS range to be between $3.45 and $3.55, including a negative impact from foreign exchange. The range excludes acquisition- and divestiture-related costs, costs related to restructuring programs and certain other items. The company has lowered its full-year 2015 GAAP EPS range to be between $1.52 and $1.71. The change in the GAAP EPS range reflects the incorporation of foreign exchange losses related to Venezuela, as well as the anticipated gain on the previously announced sale of certain migraine clinical development programs.

At current exchange rates, the company now anticipates full-year 2015 revenues to be between $38.6 billion and $39.8 billion, including a negative impact from foreign exchange and approximately $1 billion of net lost sales from acquisitions and divestitures.

In addition, the company continues to expect full-year 2015 non-GAAP marketing and administrative expenses to be below 2014 levels and R&D expenses to be modestly above 2014 levels. The company anticipates total operating expenses in the second half of 2015 to be approximately $200 million lower than in the second half of 2014.

The company now anticipates its full-year 2015 non-GAAP tax rate will be in the range of 23 to 24 percent, not including a 2015 R&D tax credit.

A reconciliation of anticipated 2015 EPS, as reported in accordance with GAAP to non-GAAP EPS that excludes certain items, is provided in the table below.

On July 28, 2015 Apogenix, a next generation immuno-oncology company, reported that it has entered into an agreement with R-Biopharm, a global provider of innovative clinical diagnostics, to develop companion diagnostic tests for Apogenix’ lead drug candidate APG101 (Press release, Apogenix, JUL 28, 2015, View Source [SID1234524546]). APG101 is a CD95 ligand inhibitor which restores the body’s immune response against tumors and inhibits invasive tumor cell growth. The drug candidate is being developed for the treatment of solid tumors and malignant hematological diseases.

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In a controlled phase II efficacy trial in patients with recurrent glioblastoma, treatment with APG101 in combination with radiotherapy has demonstrated clinical superiority in all study endpoints compared to treatment with radiotherapy alone. Glioblastoma patients with a certain biomarker associated with the CD95 ligand experienced the greatest benefit from treatment with APG101. The trial showed a statistically significant prolongation of overall survival in biomarker-positive patients treated with APG101, with a median overall survival of 16.1 months compared to 7.3 months in patients treated with radiotherapy alone.

Based on different test technologies including immunohistochemistry (IHC) and polymerase chain reaction (PCR), Apogenix and R-Biopharm will develop patient-stratifying companion diagnostic tests to identify glioblastoma patients who are most likely to benefit from treatment with APG101. The cooperation further includes the development of in vitro diagnostic tests to determine expression of the CD95 ligand in other types of tumors. Apogenix will validate the resulting diagnostic tests in a pivotal phase II/III trial in glioblastoma and in additional clinical trials for the treatment of other solid tumors.

"These diagnostic tests will allow us to develop APG101 as a targeted therapy for the treatment of cancer, so patients can benefit from a personalized treatment approach, " said Harald Fricke, M.D., Chief Medical Officer of Apogenix. "Since the CD95 ligand is expressed in many types of cancer, there is tremendous potential for the use of APG101. We look forward to joining forces with R-Biopharm and building on their long-standing experience and expertise in the development of companion and in vitro diagnostic tests."

"As a leading diagnostics partner in developing clinical test systems, R-Biopharm is passionate about bringing new diagnostic opportunities to the field of personalized medicine. This agreement is not only an acknowledgement of our companion diagnostic technology platforms, but also an important strategic step in expanding our companion diagnostics partnerships with leading pharmaceutical companies," said Dr. Frank Apostel, Vice President Companion Diagnostics of R-Biopharm. "We are very much looking forward to working with Apogenix to support their innovative and promising biopharmaceutical product and help to ensure patient access to this novel treatment as soon as possible."

(Press release, Nymox, JUL 28, 2015, View Source;fvtc=4&fvtv=6907 [SID:1234506727])

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On July 28, 2015 Purdue Research Foundation reported that Federal funding will help further develop technology discovered at Purdue University and licensed by a life sciences startup that could help cancer researchers with improved target detection and the discovery of novel pharmaceuticals (Press release, Purdue Research Foundation, JUL 28, 2015, View Source [SID:1234506728]).

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Tymora Analytical Operations has received a two-year SBIR Phase II grant of $900,000 from the National Cancer Institute to further develop its pIMAGO technology. The National Cancer Institute is part of the National Institutes of Health.

Anton Iliuk, chief technology officer, said the pIMAGO technology allows for a better understanding of what type of cancer a patient has and which therapy could be the most effective in treating the cancer.

"In a typical screening, gene mutations are regarded as the primary indications of what type of cancer an individual has. The problem is that there are often hundreds or thousands of mutations present, most of which do not progress to cancer," he said. "pIMAGO analyzes the outcomes of these mutations, which is protein phosphorylation, or the addition of a phosphate group to a protein. Examining this change on different cancer targets can often pinpoint the molecular fingerprint of the cancer, which could be used to select therapy in a more personalized manner."

The National Cancer Institute funding will develop the technology’s ability to look at a more comprehensive signaling network, rather than only one or a few proteins.

"We can examine what other pathways are active and try to target those," he said. "This could be particularly useful to check how well a drug is working, such as in cancer resistance, and to pinpoint the primary reasons for relapse and make new therapy decisions."

The pIMAGO product line has been developed through funding of other SBIR grants from the National Institutes of Health and the National Science Foundation.

Tymora Analytical Operations licenses intellectual property discovered by W. Andy Tao through the Purdue Research Foundation Office of Technology Commercialization. Tao is the company’s chief scientific officer and a professor of biochemistry at Purdue University. The company is based at Purdue Research Park of West Lafayette.