OnMay 3, 2016 Corcept Therapeutics Incorporated (NASDAQ: CORT), a pharmaceutical company engaged in the discovery, development and commercialization of drugs that treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of cortisol, reported its financial results for the quarter ended March 31, 2016 (Press release, Corcept Therapeutics, MAY 3, 2016, http://www.corcept.com/news_events/view/pr_1462308579 [SID:1234511885]).

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Corcept reported revenue of $16.1 million and a GAAP net loss of $0.00 per share for the first quarter of 2016, compared to revenue of $10.1 million and a GAAP net loss of $0.05 per share in the first quarter of 2015. The company’s cash and cash equivalents were $40.7 million at year-end, an increase of $300,000 from December 31, 2015.

The company reiterated its 2016 revenue guidance of $76-81 million.

"Corcept’s business model continues to prove itself," said Dr. Joseph K. Belanoff, Corcept’s Chief Executive Officer. "Our Cushing’s syndrome franchise remains on track to generate $76-81 million in revenue this year, which will fully support the planned advancement of our cortisol modulation platform. It is gratifying to see our discovery program, which has identified so many promising compounds, mature into a development program with the potential to produce treatments for a wide range of serious diseases."

"The breadth of the clinical program we’re building is impressive," added Robert S. Fishman, M.D., Corcept’s Chief Medical Officer. "In the coming months, we expect results from our Phase 2A trial of mifepristone in combination with eribulin to treat TNBC. CORT125134, which has already produced promising pre-clinical and Phase 1 results, has entered Phase 1/2 as a treatment for patients with a range of solid-tumor cancers and this quarter we plan for it to start Phase 2 as a treatment for Cushing’s syndrome. Equally exciting, more selective cortisol modulators are advancing towards the clinic. These compounds have shown promise in animal models of a wide range of serious diseases, including oncologic disorders, fatty liver disease, antipsychotic induced weight gain and alcoholism."

Financial Discussion

Corcept’s GAAP net loss in the first quarter of 2016 was $19,000, compared to a GAAP net loss of $4.8 million in the first quarter of 2015. Excluding non-cash expenses related to stock-based compensation and accreted interest on the company’s capped royalty obligation (the "Royalty Financing"), Corcept generated $2.2 million of non-GAAP net income in the first quarter, compared to a non-GAAP net loss of $2.7 million in the first quarter of 2015. A reconciliation of GAAP to non-GAAP net operating results is set forth below

Operating expenses for the first quarter increased to $15.5 million, from $14.1 million in the first quarter of 2015, primarily due to increases in patient support costs, compensation and professional services costs associated with our expanded field sales force, the additional distribution expense resulting from higher sales volumes, and increased spending on the clinical development of CORT125134.

Corcept’s cash and cash equivalents totaled $40.7 million as of March 31, 2016, compared to $40.4 million as of December 31, 2015. These cash balances reflect Corcept’s scheduled payments due under the Royalty Financing. Pursuant to the terms of the agreement, Corcept paid $3.0 million in the first quarter of 2016, compared to $2.8 million in the fourth quarter of 2015. Corcept expects to make its final payment under the Royalty Financing in 2017.

Conference Call

Corcept will hold a conference call on May 3, 2016, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) to discuss this announcement. To participate, dial 1-888-771-4371 from the United States or 1-847-585-4405 internationally approximately 10 minutes before the start of the call. The passcode is 42398569. A replay will be available through May 17, 2016 at 1-888-843-7419 from the United States and 1-630-652-3042 internationally. The passcode is 42398569.

About Cushing’s Syndrome

Endogenous Cushing’s syndrome is caused by prolonged exposure of the body’s tissues to high levels of the hormone cortisol and is generated by tumors that produce cortisol or ACTH. Cushing’s syndrome is an orphan indication that most commonly affects adults aged 20-50. An estimated 10-15 of every one million people are newly diagnosed with this syndrome each year, resulting in over 3,000 new patients annually in the United States. An estimated 20,000 patients in the United States have Cushing’s syndrome. Symptoms vary, but most people have one or more of the following manifestations: high blood sugar, diabetes, high blood pressure, upper body obesity, rounded face, increased fat around the neck, thinning arms and legs, severe fatigue and weak muscles. Irritability, anxiety, cognitive disturbances and depression are also common. Cushing’s syndrome can affect every organ system in the body and can be lethal if not treated effectively.

About Triple-Negative Breast Cancer (TNBC)

TNBC is a form of the disease in which the three receptors that fuel most breast cancer growth – estrogen, progesterone and the HER-2/neu gene – are not present. Because the tumor cells lack the necessary receptors, treatments that target estrogen, progesterone and HER-2 receptors are ineffective. In 2013, approximately 40,000 women were diagnosed with TNBC. We estimate that more than 75 percent of these women’s tumor cells expressed the GR receptor to which cortisol binds. There is no FDA-approved treatment and neither a targeted treatment nor an approved standard chemotherapy regimen for relapsed TNBC patients exists.

About Korlym

Korlym modulates the effect of cortisol at GR, one of the two receptors to which cortisol binds, thereby inhibiting the effects of excess cortisol in patients with Cushing’s syndrome. Since 2012, Corcept has made Korlym available as a once-daily oral treatment of hyperglycemia secondary to endogenous Cushing’s syndrome in adult patients with glucose intolerance or diabetes mellitus type 2 who have failed surgery or are not candidates for surgery. Korlym was the first FDA-approved treatment for that illness and the FDA has designated it as an Orphan Drug for that indication.

About CORT125134

CORT125134 is the lead compound in Corcept’s portfolio of selective cortisol modulators. It is a non-steroidal competitive antagonist of GR that does not bind to the body’s other hormone receptors, including the progesterone receptor. It is the affinity of Korlym for the progesterone receptor that results in termination of pregnancy and can cause endometrial thickening and irregular vaginal bleeding in some women. CORT125134 will not have these effects. The compound is proprietary to Corcept and is protected by composition of matter and method of use patents extending into 2033.

On May 3, 2016 Foundation Medicine, Inc. (NASDAQ:FMI) reported the launch of FoundationACT (Assay for Circulating Tumor DNA), an analytically validated and accurate blood-based circulating tumor DNA (ctDNA) assay that provides patients and oncologists with a new option for comprehensive genomic profiling when a tissue biopsy is not feasible or when tissue is not available (Press release, Foundation Medicine, MAY 3, 2016, View Source [SID:1234511842]). By analyzing circulating tumor DNA isolated from a patient’s blood, FoundationACT can identify clinically relevant genomic alterations, and like Foundation Medicine’s tissue-based genomic profiles, FoundationOne and FoundationOne Heme, FoundationACT delivers this comprehensive molecular information in a concise report that matches the findings with potentially relevant targeted therapies and clinical trials.

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"Our goal has always been to deliver a highly accurate and sensitive assay available for blood based samples, and the confirmatory data produced by our clinical collaborators indicates that we have succeeded in achieving that with the release of FoundationACT," said Vincent Miller, M.D., chief medical officer of Foundation Medicine. "Bringing the rigor used to develop and validate FoundationOne to this assay, we believe we have overcome many of the clinical limitations presented by other tests in the liquid biopsy field. Launching FoundationACT strengthens our market leading position as the go-to resource for a complete, end-to-end offering of comprehensive molecular information solutions."

The presence of ctDNA, which is DNA shed from tumors that circulates in blood, is a well-established phenomenon that has led to the development of non-invasive tumor sequencing assays. However, the concentration of ctDNA compared to other DNA fragments derived from other tissue sources can vary significantly depending on tumor type and disease stage. For many cancer patients, this means that the proportion of detectable tumor DNA in the blood is extremely low, making the detection of therapeutically relevant genomic alterations much more difficult and error prone as compared to tissue-based approaches.

FoundationACT, which was launched to Foundation Medicine’s pharmaceutical partners for research use in December 2015, interrogates all clinically relevant alterations across 62 genes and fusions across six genes, and it has been optimized for sensitivity and specificity of all classes of molecular alterations, including base substitutions, insertions and deletion, focal amplifications and gene fusions. The assay was developed for patients who are not candidates for comprehensive genomic profiling with FoundationOne. Factors that may preclude patients from undergoing FoundationOne testing include insufficient or inadequate tissue from a recent biopsy, safety risks associated with biopsy, or medical contraindications to re-biopsy. In July 2015, Foundation Medicine initiated a large-scale, multi-center prospective clinical study to clinically validate FoundationACT across various cancers and stages of the disease. A portion of the patients in the study will include those with earlier-stage disease, allowing the company to investigate how different tumor types shed DNA into the bloodstream at different stages of the disease.

Technical Validation Data Confirms Accuracy, Sensitivity of FoundationACT Genomic Profiling Assay

At the Annual Meeting of the Advances in Genome Biology and Technology (AGBT) in February 2016, Foundation Medicine reported data from its analytic validation study in a presentation titled, "Assessment of the Relative Clinical Utility of ctDNA and Tissue Biopsies for the Detection of Actionable Genomic Alterations in Routine Clinical Oncology Specimens." Study highlights demonstrated that FoundationACT results were 100 percent concordant with FoundationOne and droplet digital PCR (ddPCR) results across 87 base substitutions (43 at < 5% MAF), three indels and five genomic alterations.

At the American Association of Cancer Research Annual Meeting in April 2016, Foundation Medicine further reported analytical validation data in a poster presentation titled, "Rigorous Validation of a Clinical Circulating Tumor DNA Assay for Cancer Molecular Profiling." As part of this study, results compared alterations from patient-matched ctDNA and FFPE biopsies across more than 200 samples from lung, breast and other cancers. This rigorous analytic validation study demonstrated ≥99 percent sensitivity in the detection of alterations present in blood at low frequency with a very low rate of false positives, realizing the potential of ctDNA-based molecular profiling for the management of patients with cancer. In 48 clinical ctDNA samples, 95 alterations of all classes were 100 percent confirmed by orthogonal testing.

On May 3, 2016 Foundation Medicine, Inc. (NASDAQ:FMI) reported financial and operating results for its first quarter ended March 31, 2016 (Press release, Foundation Medicine, MAY 3, 2016, View Source [SID:1234511841]). Highlights for the quarter included:

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Achieved first quarter revenue of $30.4 million, 57% year-over-year growth;
Reported 8,985 clinical tests in the first quarter, 14% year-over-year growth;
Grew the FoundationCORE molecular information knowledgebase, now approaching 80,000 patient cases;
Presented analytic validation of FoundationACT, the company’s circulating tumor DNA (ctDNA) assay;
Publicly-released a broad pediatric data set from FoundationCORE for research purposes to enable precision medicine;
Published 9 manuscripts in high-quality, peer-reviewed journals and delivered 41 podium and poster talks at various medical and scientific meetings.
Foundation Medicine reported total revenue of $30.4 million in the first quarter of 2016, compared to $19.3 million in the first quarter of 2015 and $26.1 million in the fourth quarter of 2015. Revenue from clinical testing in the first quarter of 2016 was $10.2 million, compared to $11.1 million in the first quarter of 2015 and $12.0 million in the fourth quarter of 2015.

The company reported 8,985 clinical tests in the first quarter of 2016, a 14% increase from the same quarter last year. This number includes 7,957 FoundationOne tests and 1,028 FoundationOne Heme tests.

Revenue from biopharmaceutical customers more than doubled year-over-year to $20.2 million in the first quarter of 2016, compared to $8.2 million in the first quarter of 2015 and $14.1 million in the fourth quarter of 2015. This growth was fueled by the achievement of milestone revenue during the first quarter. The results of 2,622 tests were reported to biopharmaceutical customers in this year’s first quarter.

"Foundation Medicine delivered a solid first quarter highlighted by strong revenue growth and healthy clinical volume," said Michael Pellini, M.D., chief executive officer of Foundation Medicine. "Since the beginning of the year, we have also made great strides in generating a tremendous amount of data to support the clinical utility of our comprehensive genomic profiling approach across a diverse set of cancers. We expect that these data, coupled with our best-in-class portfolio of analytically validated assays, which now includes FoundationACT, will be critical differentiators with physicians, payers, and most importantly, patients."

The company’s molecular information knowledgebase, FoundationCORE, grew to nearly 80,000 patient cases. FoundationCORE is a unique asset and critical component of the value that Foundation Medicine delivers to its biopharmaceutical and physician customers. The increasing scale and breadth of a high quality, clinically relevant oncology data set derived from the company’s analytically validated testing platform continues to enhance clinical practice and enable improved outcomes for patients.

Total operating expenses for the first quarter of 2016 were approximately $36.5 million compared with $34.0 million for the fourth quarter of 2015. Net loss was approximately $17.3 million in the first quarter of 2016, or a $0.50 loss per share. At March 31, 2016, the company held approximately $213.5 million in cash, cash equivalents and marketable securities.

Recent Enterprise Highlights

Launched FoundationACT, the company’s ctDNA assay to clinical customers. FoundationACT was developed with the same rigorous analytical validation standards as FoundationOne and FoundationOne Heme, and is the third clinical product launch by the company in just four years.
Announced an agreement with AstraZeneca to develop novel companion diagnostic assays to enable physicians to identify patients most likely to benefit from targeted medicines within AstraZeneca’s oncology pipeline.
Expanded the company’s U.S. laboratory footprint to include a second site at Research Triangle Park in North Carolina. When operational, the company expects this new facility will support continued innovation and expansion of its product portfolio, provide important lab redundancies, increase operational flexibility, and broaden commercial opportunities.
2016 Outlook

Foundation Medicine’s business and financial outlook for 2016 remains unchanged:

The company expects 2016 revenue will be in the range of $110 to $120 million.
The company expects to deliver between 37,000 and 40,000 FoundationOne and FoundationOne Heme clinical tests in 2016.
The company expects operating expenses will be in the range of $175 and $185 million.
The company expects to expand upon reimbursement progress made in 2015 and drive additional coverage decisions.

On May 3, 2016 Illumina, Inc. (NASDAQ: ILMN) reported its financial results for the first quarter of fiscal year 2016 (Press release, Illumina, MAY 3, 2016, View Source [SID:1234511839]).

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First quarter 2016 results:

Revenue of $572 million, a 6% increase compared to $539 million in the first quarter of 2015, and an increase of 7% on a constant currency basis
GAAP net income attributable to Illumina stockholders for the quarter of $90 million, or $0.60 per diluted share, compared to $137 million, or $0.92 per diluted share, for the first quarter of 2015
Non-GAAP net income attributable to Illumina stockholders for the quarter of $106 million, or $0.71 per diluted share, compared to $135 million, or $0.91 per diluted share, for the first quarter of 2015 (see the table entitled "Itemized Reconciliation Between GAAP and Non-GAAP Net Income Attributable to Illumina Stockholders" for a reconciliation of these GAAP and non-GAAP financial measures)
Cash flow from operations of $40 million and free cash flow of negative $14 million for the quarter, compared to $67 million and positive $30 million in the prior year period. Increased operating expenses and higher capital expenditures contributed to the lower free cash flow.
Gross margin in the first quarter of 2016 was 69.4% compared to 69.6% in the prior year period. Excluding the effect of non-cash stock compensation expense and amortization of acquired intangible assets, non-GAAP gross margin was 71.7% for the first quarter of 2016 compared to 72.2% in the prior year period.

Research and development (R&D) expenses for the first quarter of 2016 were $124.0 million compared to $91.8 million in the prior year period. R&D expenses included $10.7 million and $11.3 million of non-cash stock compensation expense in the first quarters of 2016 and 2015, respectively. Excluding these charges and contingent compensation, R&D expenses as a percentage of revenue were 19.8%, including 0.9% attributable to GRAIL and Helix. This compares to 14.9% in the prior year period.

Selling, general and administrative (SG&A) expenses for the first quarter of 2016 were $149.2 million compared to $116.3 million in the prior year period. SG&A expenses included $22.0 million and $18.0 million of non-cash stock compensation expense in the first quarters of 2016 and 2015, respectively. Excluding these charges, amortization of acquired intangible assets, and contingent compensation, SG&A expenses as a percentage of revenue were 21.9%, including 0.6% attributable to GRAIL and Helix. This compares to 18.0% in the prior year period.

Depreciation and amortization expenses were $33.2 million and capital expenditures were $53.4 million during the first quarter of 2016. The company settled the remaining 0.25% Convertible Senior Notes of $75.5 million. At the close of the quarter, the company held $1.34 billion in cash, cash equivalents and short-term investments, compared to $1.39 billion as of January 3, 2016.

"As we have previously shared, Q1 was a slower start to the year than we expected," stated Jay Flatley, Chairman and CEO. "Our view of the growth potential of the sequencing market remains unchanged, as the largest opportunities are in their earliest stages of development. In the near-term, we are focused on improving execution to restore the growth rate we believe our markets can support."

Updates since our last earnings release:

Introduced BaseSpace Informatics Suite, a complete set of genomics software tools and solutions to facilitate precision medicine and genomics research
Applied CE mark to VeriSeq NIPT Analysis Software for use in clinical laboratories
Announced partnerships to enable long read applications including co-marketing agreements with 10X Genomics and NRGene
Entered into a partnership with Genomics England to develop a platform and knowledge base to improve and automate genome interpretation
Committed $100 million to a new venture capital firm that will pursue early stage investments which are strategically aligned with Illumina’s vision
Announced that on July 5, 2016 Jay Flatley will assume the role of Executive Chairman of the Board of Directors and Francis deSouza will be appointed President and Chief Executive Officer
Financial outlook and guidance

The non-GAAP financial guidance discussed below reflects certain pro forma adjustments to assist in analyzing and assessing our core operational performance. Please see our Reconciliation of Non-GAAP Financial Guidance included in this release for a reconciliation of the GAAP and non-GAAP financial measures.

For fiscal 2016, the company is projecting approximately 12% revenue growth and non-GAAP earnings per diluted share attributable to Illumina stockholders of $3.35 to $3.45. For the second quarter 2016, the company is projecting revenue of $590 million to $595 million and non-GAAP earnings per diluted share attributable to Illumina stockholders of $0.72 to $0.74.

Quarterly conference call information

The conference call will begin at 2:00 pm Pacific Time (5:00 pm Eastern Time) on Tuesday, May 3, 2016. Interested parties may listen to the call by dialing 888.687.3295 (passcode: 85797542), or if outside North America by dialing +1.503.406.4070 (passcode: 85797542). Individuals may access the live teleconference in the Investor Relations section of Illumina’s web site under the "company" tab at www.illumina.com.

A replay of the conference call will be available from 5:00 pm Pacific Time (8:00 pm Eastern Time) on May 3, 2016 through May 10, 2016 by dialing 855.859.2056 (passcode: 85797542), or if outside North America by dialing +1.404.537.3406 (passcode: 85797542).

Statement regarding use of non-GAAP financial measures

The company reports non-GAAP results for diluted net income per share, net income, gross margins, operating expenses, operating margins, other income, and free cash flow in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP.

The company’s financial measures under GAAP include substantial charges such as stock compensation expense, amortization of acquired intangible assets, non-cash interest expense associated with the company’s convertible debt instruments that may be settled in cash, and others that are listed in the itemized reconciliations between GAAP and non-GAAP financial measures included in this press release. Management believes that presentation of operating results that excludes these items provides useful supplemental information to investors and facilitates the analysis of the company’s core operating results and comparison of operating results across reporting periods. Management also believes that this supplemental non-GAAP information is useful to investors in analyzing and assessing the company’s past and future operating performance.

The company encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP information and the reconciliation between these presentations, to more fully understand its business. Reconciliations between GAAP and non-GAAP results are presented in the tables of this release.

On May 3, 2016 Fresenius reported Q1 results for 2016(Press release, Fresenius, MAY 3, 2016, View Source [SID:1234511838]).

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Q1/2016:
Sales: €6.9 billion (+7%, +7% in constant currency)
EBIT1: €959 million (+13%, +11% in constant currency)
Net income1,2: €362 million (+24%, +23% in constant currency)
Ulf Mark Schneider, CEO of Fresenius, said: "We have seen a strong start into 2016, reflected in our double-digit earnings growth. All business segments and regions have contributed to this success, demonstrating yet again enormous consistency in our sales and earnings development. We remain fully on track to achieve our 2016 and mid-term targets."
12015 before special items
2Net income attributable to shareholders of Fresenius SE & Co. KGaA
Group guidance for 2016 confirmed
Fresenius confirms its guidance for 2016. Sales are expected to increase by 6% to 8% in constant currency. Net income1,2, is expected to grow by 8% to 12% in constant currency.
The net debt/EBITDA3 ratio is expected to be approximately 2.5 at the end of 2016.
1Net income attributable to shareholders of Fresenius SE & Co. KGaA
22015 before special items
3Calculated at FY average exchange rates for both net debt and EBITDA; excluding potential acquisitions
7% sales growth in constant currency
Group sales increased by 7% (7% in constant currency) to €6,914 million (Q1/2015: €6,483 million). Organic sales growth was 7%. Acquisitions contributed 1% and divestitures reduced sales by 1%.
Group sales by region:

23% net income1 growth in constant currency
Group EBITDA2 increased by 11% (10% in constant currency) to €1,237 million (Q1/2015: €1,115 million). Group EBIT2 increased by 13% (11% in constant currency) to €959 million (Q1/2015: €851 million). The EBIT margin2 increased to 13.9% (Q1/2015: 13.1%).
Group net interest decreased to -€152 million (Q1/2015: -€165 million), mainly due to more favorable financing terms and lower net debt.
The Group tax rate (before special items) decreased to 28.4% (Q1/2015: 30.2%), mainly due to a lower tax rate at Fresenius Medical Care.
Noncontrolling interest increased to €216 million (Q1/2015: €187 million), of which 95% was attributable to the noncontrolling interest in Fresenius Medical Care.
Group net income1,2, increased by 24% (23% in constant currency) to €362 million (Q1/2015: €292 million). Earnings per share1,2 increased by 22% (22% in constant currency) to €0.66 (Q1/2015: €0.54).
1Net income attributable to shareholders of Fresenius SE & Co. KGaA
22015 before special items
3Calculated at FY average exchange rates for both net debt and EBITDA; excluding potential acquisitions
Continued investment in growth
Spending on property, plant and equipment was €313 million (Q1/2015: €273 million), primarily for the modernization and expansion of dialysis clinics, production facilities and hospitals. Total acquisition spending was €204 million (Q1/2015: €104 million).
Cash flow development
Operating cash flow decreased by 37% to €334 million (Q1/2015: €531 million) with a margin of 4.8% (Q1/2015: 8.2%). The decrease was mainly due to an adjustment in invoicing within the quarter and the timing of cash payroll payments at Fresenius Medical Care North America. Fresenius Medical Care expects that these effects will have no meaningful impact on the full year 2016 cash flow.
Free cash flow before acquisitions and dividends decreased to €2 million (Q1/2015: €258 million). Free cash flow after acquisitions and dividends was -€241 million (Q1/2015: €256 million).
Solid balance sheet structure
The Group’s total assets decreased by 1% (increased 1% in constant currency) to €42,445 million (Dec. 31, 2015: €42,959 million). Current assets grew by 1% (3% in constant currency) to €10,584 million (Dec. 31, 2015: €10,479 million). Non-current assets decreased by 2% (increased 1% in constant currency) to €31,861 million (Dec. 31, 2015: € 32,480 million).
Total shareholders’ equity was virtually unchanged at €18,009 million (Dec. 31, 2015: €18,003 million). In constant currency, it increased by 3%. The equity ratio increased to 42.4% (Dec. 31, 2015: 41.9%).
Group debt decreased by 1% (increased 1% in constant currency) to €14,549 million (Dec. 31, 2015: € 14,769 million). As of March 31, 2016, the net debt/EBITDA ratio was 2.671 (Dec. 31, 2015: 2.681).
12015 before special items; at LTM average exchange rates for both net debt and EBITDA
Business Segments
Fresenius Medical Care
Fresenius Medical Care is the world’s largest provider of products and services for individuals with renal diseases. As of March 31, 2016, Fresenius Medical Care was treating 294,043 patients in 3,432 dialysis clinics. Along with its core business, the company seeks to expand the range of medical services in the field of care coordination.

9% sales growth in constant currency
Strong sales and EBIT growth in North America
2016 outlook confirmed
Sales increased by 6% (9% in constant currency) to US$4,205 million (Q1/2015: US$3,960 million). Organic sales growth was 7%. Acquisitions contributed 2%. Currency translation effects reduced sales by 3%.
Health Care services sales (dialysis services and care coordination) increased by 7% (9% in constant currency) to US$3,414 million (Q1/2015: US$3,182 million). Dialysis product sales increased by 2% (6% in constant currency) to US$791 million (Q1/2015: US$778 million).
In North America, sales increased by 10% to US$3,044 million (Q1/2015: US$2,771 million). Health Care services sales grew by 10% to US$2,832 million (Q1/2015: US$2,571 million). Dialysis product sales increased by 6% to US$212 million (Q1/2015: US$200 million).
Sales outside North America decreased by 2% (increased by 7% in constant currency) to US$1,158 million (Q1/2015: US$1,180 million). Health Care services sales decreased by 5% (increased by 6% in constant currency) to US$582 million (Q1/2015: US$611 million). Dialysis product sales increased by 1% (8% in constant currency) to US$576 million (Q1/2015: US$569 million).
EBIT increased by 7% (8% in constant currency) to US$540 million (Q1/2015: US$504 million). The EBIT margin was 12.8% (Q1/2015: 12.7%).
Net income1 increased by 9% (8% in constant currency) to US$228 million (Q1/2015: US$210 million).
Operating cash flow decreased by 60% to US$180 million (Q1/2015: US$447 million). The cash flow margin was 4.3% (Q1/2015: 11.3%). The decrease was mainly due to an adjustment in invoicing within the quarter and the timing of cash payroll payments at Fresenius Medical Care North America. Fresenius Medical Care expects that these effects will have no meaningful impact on the full year 2016 cash flow.
Fresenius Medical Care confirms its outlook for 2016. The company expects sales to grow by 7% to 10% in constant currency and net income1 is expected to increase by 15% to 20%2 in 2016.
For further information, please see Fresenius Medical Care’s Investor News at www.freseniusmedicalcare.com.
1Net income attributable to shareholders of Fresenius Medical Care AG & Co. KGaA
22015 before GranuFlo/NaturaLyte settlement costs (-US$37 million after tax) and before acquisitions (US$9 million after tax); hence the basis for expected net income growth is US$1,057 million.

Fresenius Kabi
Fresenius Kabi offers intravenously administered generic drugs, clinical nutrition and infusion therapies for seriously and chronically ill patients in the hospital and outpatient environments. The company is also a leading supplier of medical devices and transfusion technology products.

10% organic sales growth in Q1
19% constant currency EBIT1 growth in Q1
2016 outlook confirmed
Sales increased by 5% (8% in constant currency) to €1,470 million (Q1/2015: €1,394 million). Organic sales growth was 10%. Divestitures and currency translation effects reduced sales by 2% and 3% respectively.
Sales in Europe decreased by 1% (increased organically by 1%) to €512 million (Q1/2015: €518 million), mainly due to the divestment of the German oncology compounding business in February 2015. Sales in North America increased by 22% (organic growth: 20%) to €567 million (Q1/2015: €473 million). North American sales growth was mainly driven by persisting IV drug shortages as well as new product launches. Adverse currency translation effects decreased sales in Asia-Pacific by 5% (increased organically by 7%) to €254 million (Q1/2015: €268 million) and in Latin America/Africa by 5% (increased organically by 21%) to €128 million (Q1/2015: €135 million).
EBIT1 increased by 20% (19% in constant currency) to €309 million (Q1/2015: €257 million). The EBIT margin1 improved to 21.0% (Q1/2015: 18.5%).
Net income2 increased by 28% (26% in constant currency) to €179 million (Q1/2015: €140 million).
Based on the excellent net income development operating cash flow increased by 49% to €124 million (Q1/2015: €83 million) with a margin of 8.4% (Q1/2015: 6.0%).
Fresenius Kabi confirms its outlook for 2016 and projects low single-digit organic sales growth. EBIT1 in constant currency is expected to be roughly flat compared with 2015.
12015 before special items
2Net income attributable to shareholders of Fresenius Kabi AG; 2015 before special items
Fresenius Helios
Fresenius Helios is Germany’s largest hospital operator. HELIOS operates 111 hospitals, thereof 87 acute care clinics (including seven maximum care hospitals in Berlin-Buch, Duisburg, Erfurt, Krefeld, Schwerin, Wiesbaden and Wuppertal) and 24 post-acute care clinics. HELIOS treats more than 4.7 million patients per year, thereof approximately 1.3 million inpatients, and operates more than 34,000 beds.

3% organic sales growth
50 bps EBIT margin1 increase to 11.1%
2016 outlook confirmed
Sales increased by 3% to €1,435 million (Q1/2015: €1,391 million). Organic sales growth was 3%. Acquisitions and divestitures had no material effect.
EBIT1 grew by 8% to €159 million (Q1/2015: €147 million). The EBIT margin1 increased to 11.1% (Q1/2015: 10.6%).
Net income2 increased by 16% to €124 million (Q1/2015: €107 million).
Fresenius Helios confirms its outlook for 2016 and projects organic sales growth of 3% to 5%. EBIT is expected to increase to €670 to €700 million.
12015 before special items
2Net income attributable to shareholders of HELIOS Kliniken GmbH; 2015 before special items
Fresenius Vamed
Fresenius Vamed manages projects and provides services for hospitals and other health care facilities worldwide. The portfolio ranges along the entire value chain: from project development, planning, and turnkey construction, via maintenance and technical management, to total operational management.

Project and service business contributed equally to 6% organic sales growth
Strong order intake of €237 million
2016 outlook confirmed
Sales increased by 5% (5% in constant currency) to €218 million (Q1/2015: €208 million). Organic sales growth was 6%. Sales in the project business increased by 6% to €85 million (Q1/2015: €80 million). Sales in the service business grew by 4% to €133 million (Q1/2015: €128 million).
EBIT remained unchanged with €7 million (Q1/2015: €7 million). The EBIT margin was 3.2% (Q1/2015: 3.4%).
Net income1 grew by 25% to €5 million (Q1/2015: €4 million).
Order intake increased to €237 million (Q1/2015: €192 million). As of March 31, 2016, order backlog grew to €1,803 million (December 31, 2015: €1,650 million).
Fresenius Vamed confirms its outlook for 2016 and expects organic sales growth in the range of 5% to 10% and EBIT growth of 5% to 10%.