Perrigo To Release Fourth Quarter And Calendar Year 2017 Financial Results On February 27, 2018

On February 8, 2018 Perrigo Company plc (NYSE; TASE: PRGO) reported that it will release its fourth quarter and calendar year 2017 financial results on Tuesday, February 27, 2018 (Press release, Perrigo Company, FEB 8, 2018, View Source [SID1234523861]). The Company will also host a conference call beginning at 9:30 a.m. (EST).

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The conference call will be available live via webcast to interested parties in the investor relations section of the Perrigo website at View Source or by phone at 877-248-9413, International 973-582-2737, and reference ID #2088843. A taped replay of the call will be available beginning at approximately 12:00 p.m. (EST) Tuesday, February 27, until midnight Friday, March 9, 2018. To listen to the replay, dial 800-585-8367, International 404-537-3406, and use access code 2088843.

ERLEADA™ (apalutamide), a Next-Generation Androgen Receptor Inhibitor, Lowered Risk of Metastasis or Death in Patients with Non-Metastatic Castration-Resistant Prostate Cancer

On February 8, 2018 The Janssen Pharmaceutical Companies of Johnson & Johnson reported new findings from the Phase 3 SPARTAN clinical trial that showed treatment with ERLEADA, an investigational, next-generation1 androgen receptor inhibitor, decreased risk of metastasis or death by 72 percent and improved median metastasis-free survival (MFS) by more than two years (difference of 24.3 months) in patients with non-metastatic castration-resistant prostate cancer (CRPC) whose prostate specific antigen (PSA) is rapidly rising, compared to placebo (Press release, Johnson & Johnson, FEB 8, 2018, View Source [SID1234523893]). The results were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU) in San Francisco (Abstract #161) and were simultaneously published in The New England Journal of Medicine.

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"While there have been advances in the treatment of prostate cancer over the years, metastatic castration-resistant prostate cancer is still a lethal disease. These compelling results are the first to show that metastases can be delayed in these patients," said Eric Small, M.D. FASCO, Professor of Medicine, and Chief of the Division of Hematology and Oncology at the University of California, San Francisco, and lead SPARTAN study investigator. "These data suggest that apalutamide could potentially be a new standard of care for patients with non-metastatic castration-resistant prostate cancer."

SPARTAN, a Phase 3, randomized, double-blind, placebo-controlled, multicenter study, enrolled 1,207 patients with non-metastatic castration-resistant prostate cancer and was conducted at 332 sites in 26 countries in North America, Europe, Asia-Pacific and Australia. Patients were randomized 2:1 to receive ERLEADA in combination with androgen deprivation therapy (ADT) (n=806), or placebo in combination with ADT (n=401).

ERLEADA in combination with ADT decreased the risk of metastasis or death by 72 percent compared to placebo in combination with ADT (HR = 0.28; 95% CI, 0.23-0.35; P<0.0001).2 The median MFS was 40.5 months for ERLEADA in combination with ADT compared to 16.2 months for placebo in combination with ADT, prolonging MFS by more than two years. MFS benefit was consistently seen across all subgroups of patients.2

"Delaying the metastasis of prostate cancer is critical. Once the cancer starts to spread, the patient’s overall health, well-being and prognosis change drastically," said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head of Oncology at Janssen Research & Development, LLC. "The ERLEADA data presented at ASCO (Free ASCO Whitepaper) GU demonstrate the important impact this medicine can have for patients with prostate cancer. Janssen is committed to addressing unmet needs for treatment across all stages of disease progression with novel combinations and novel therapeutics."

In addition to improving metastasis free survival, ERLEADA in combination with ADT, compared to placebo in combination with ADT, demonstrated clinical improvement across secondary endpoints, with statistically significant improvements in time to metastasis (TTM; median of 40.5 months in the ERLEADA arm compared to median of 16.6 months in the placebo arm) and progression-free survival (PFS; median of 40.5 months in the ERLEADA arm compared to median of 14.7 months in the placebo arm). Treatment with ERLEADA decreased the risk of symptomatic progression by 55 percent compared with placebo (HR=0.45; 95% CI, 0.32-0.63; P<0.0001). ERLEADA was associated with a 30 percent risk reduction of death compared to placebo at this early interim analysis for overall survival (OS).2 In exploratory endpoints, ERLEADA in combination with ADT, compared to placebo in combination with ADT, also achieved a 94 percent risk reduction in time to PSA progression (HR = 0.06; 95% CI, 0.05-0.08; P<0.0001), and a 51 percent risk reduction in second progression-free survival (PFS2). The combination of ERLEADA and ADT was tolerable, with maintenance of overall health-related quality of life.

The most common Grade 3/4 treatment-emergent adverse events (TEAEs) for ERLEADA in combination with ADT versus placebo in combination with ADT were rash (5.2 percent vs. 0.3 percent), fall (1.7 percent vs. 0.8 percent) and fracture (2.7 percent vs. 0.8 percent). Treatment discontinuation due to adverse events were 11 percent in the ERLEADA arm compared to 7 percent in the placebo arm. Rates of serious adverse events (SAEs) were similar in the ERLEADA in combination with ADT arm versus placebo in combination with ADT arm (25 percent vs. 23 percent, respectively).

About Non-Metastatic Castration-Resistant Prostate Cancer
Non-metastatic castration-resistant prostate cancer (CRPC) refers to a disease stage when the cancer no longer responds to medical or surgical treatments that lower testosterone, but has not yet been discovered in other parts of the body using a total body bone scan or CT scan.3 Features include: lack of detectable metastatic disease;3 rapidly rising prostate-specific antigen while on androgen deprivation therapy (ADT) and serum testosterone level below 50 ng/dL.4,5 Ninety percent of patients with non-metastatic CRPC will eventually develop bone metastases, which can lead to pain, fractures and spinal cord compression.6 The relative 5-year survival rate for patients with distant stage prostate cancer is 30 percent.7 While it is critical to delay the onset of metastasis in patients with non-metastatic CRPC, there are currently no FDA approved treatments.

About ERLEADA
ERLEADA (apalutamide) is an investigational, next-generation1 oral androgen receptor (AR) inhibitor that blocks the androgen signaling pathway in prostate cancer cells. ERLEADA inhibits the growth of cancer cells in three ways: by preventing the binding of androgen to the AR; by stopping the AR from entering the cancer cells; and by preventing the AR from binding to the DNA of the cancer cell.

Cambrex Reports Fourth Quarter And Full Year 2017 Financial Results

On February 8, 2018 Cambrex Corporation (NYSE: CBM), a leading manufacturer of small molecule innovator and generic Active Pharmaceutical Ingredients (APIs), reported results for the fourth quarter and full year ended December 31, 2017 (Press release, Cambrex, FEB 8, 2018, View Source [SID1234523822]).

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Highlights

Net revenue increased 2.5% to $182.3 million compared to $177.9 million in the same quarter last year. Excluding the impact of foreign exchange, net revenue increased 1%. Full year net revenue increased 9% to $534.5 million, compared to $490.6 million in the full year 2016.
GAAP Diluted EPS from continuing operations increased 4% to $1.20 per share from $1.15 per share in the same quarter last year. Full year GAAP Diluted EPS from continuing operations increased 17% to $3.10 per share from $2.65 per share in the full year 2016.
EBITDA increased to $64.7 million compared to $63.6 million in the same quarter last year. Full year Adjusted EBITDA increased 13% to $174.6 million from $154.2 million in the full year 2016 (see table at the end of this release).
Net cash was $183.3 million at the end of the year, an increase of $64.9 million during the quarter and $109.1 million during the year.
The Company continued to execute on its strategic growth plan, investing in new manufacturing capacity and analytical laboratory space at its facilities in Charles City, Iowa, High Point, North Carolina, Karlskoga, Sweden and Milan, Italy.
The Company expects full year 2018 Adjusted net revenue, excluding the impact of foreign currency and change in accounting principle, to be between -2% and 2% compared to 2017 and Adjusted EBITDA to be between $150 and $160 million. (see Financial Expectations – Continuing Operations section below for related explanations and additional financial guidance).
"We are pleased with our strong financial performance in 2017, our seventh straight year of solid growth. The fourth quarter was a record revenue quarter with Net revenue up 2.5% compared to a record fourth quarter last year. Strong performance at our manufacturing facilities resulted in higher profit margins versus last year," commented Steven M. Klosk, President and Chief Executive Officer of Cambrex.

"With our recently completed large scale manufacturing capacity projects and the on-going investments in R&D and pilot plant capabilities, we are well positioned to ensure our facilities are able to keep up with the strong market demand."

Basis of Reporting
The Company has provided a reconciliation of GAAP amounts to adjusted (i.e. Non-GAAP) amounts at the end of this press release. Cambrex management believes that the adjusted amounts provide useful information to investors due to the magnitude and nature of certain expenses recorded in the GAAP amounts.

Fourth Quarter 2017 Operating Results – Continuing Operations
Net revenue was $182.3 million, an increase of $4.4 million, or 2.5%, compared to the fourth quarter of 2016. Excluding a 1.5% favorable impact of foreign exchange compared to the fourth quarter of 2016, net revenue increased 1%. The increase primarily reflects higher volumes in the generic and controlled substance product categories, partially offset by lower volumes and pricing of certain branded APIs.

Gross margin decreased to 43% from 45% compared to the same quarter last year. Excluding a 1% unfavorable impact of foreign exchange compared to the fourth quarter of 2016, margins were relatively flat year over year.

Selling, general and administrative expenses were $18.7 million, compared to $18.2 million in the same quarter last year. This increase was primarily due to higher expenses related to consulting for an operational excellence initiative.

Research and development expenses were $4.3 million, compared to $3.5 million in the same quarter last year. This increase was primarily driven by costs to develop new generic drug products and higher personnel related expenses.

Operating profit decreased to $55.9 million from $56.7 million in the same quarter last year. This decrease was primarily the result of higher operating expenses as described above.

Adjusted EBITDA was $64.7 million compared to $64.4 million in the same quarter last year (see table at the end of this press release).

Income tax expense was $15.6 million resulting in an effective tax rate of 28% compared to $18.4 million and an effective tax rate of 33% in the same quarter last year. The favorable impact of immediately recognizing certain effects of share-based compensation as required by a recently adopted accounting standard and the unfavorable impact of U.S. tax reform legislation enacted in December 2017, was negligible.

Income from continuing operations was $40.2 million or $1.20 per share compared to $37.9 million or $1.15 per share in the same quarter last year. Adjusted income from continuing operations was $42.4 million or $1.27 per share, compared to $40.8 million or $1.23 per share in the same quarter last year (see table at the end of this press release).

Capital expenditures and depreciation were $13.2 million and $8.3 million, respectively, compared to $11.9 million and $6.6 million, respectively, in the same quarter last year.

Net cash was $183.3 million at the end of the fourth quarter, an increase of $64.9 million during the quarter.

Financial Expectations – Continuing Operations
The following table shows the Company’s current expectations for its full year 2018 financial performance:

Expectations
Adjusted net revenue -2% – 2%
Adjusted EBITDA $150 – $160 million
Adjusted income from continuing operations per share $2.80 – $3.03
Free cash flow $35 – $45 million
Capital expenditures $70 – $80 million
Depreciation and amortization $33 – $37 million
Adjusted effective tax rate 23% – 25%
Consistent with the Company’s usual guidance practices, these financial expectations are for continuing operations and exclude the impact of any potential acquisitions, divestitures, restructuring activities, outcomes of tax disputes and the adoption of the new revenue recognition guidance effective January 1, 2018. Adjusted net revenue expectations exclude the impact of foreign exchange and change in accounting principle. EBITDA, Adjusted EBITDA and Adjusted income from continuing operations per share for 2018 will be computed on a basis consistent with the reconciliation of the 2017 financial results in the tables at the end of this press release. Free cash flow is defined as the change in debt, net of cash during the year. Adjusted effective tax rate excludes certain effects of share-based payments that were possibly deferred under the previous guidance. The tax rate will be sensitive to the Company’s geographic mix of income, changes in the tax laws or rates within the countries in which the Company operates and the effects of certain share-based payments.

The financial information contained in this press release is unaudited, subject to revision and should not be considered final until the Company’s 2017 Form 10-K is filed with the SEC.

Conference Call and Webcast
A conference call to discuss the Company’s fourth quarter and full year 2017 results will begin at 8:30 a.m. Eastern Time on February 8, 2018 and can be accessed by calling 1-888-394-8218 for domestic and +1-323-701-0226 for international. Please use the passcode 9709552 and call approximately 10 minutes prior to the start time. A webcast will be available in the Investors section on the Cambrex website located at www.cambrex.com. A telephone replay of the conference call will be available through February 15, 2018 by calling 1-888-203-1112 for domestic and +1-719-457-0820 for international. Please use the passcode 9709552 to access the replay.

Radius Health to Present at Leerink Partners 7th Annual Global Healthcare Conference

On February 8, 2018 Radius Health, Inc. (Nasdaq:RDUS), a science-driven fully integrated biopharmaceutical company that is committed to developing and commercializing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases, reported that Jesper Høiland, President and CEO of the Company, will present a corporate update at the Leerink Partners 7th Annual Global Healthcare Conference on Thursday, February 15, 2018 (Press release, Radius, FEB 8, 2018, View Source [SID1234523864]).

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Information on the presentation is as follows:

Event: Leerink Partners 7th Annual Global Healthcare Conference
Date: Thursday, February 15, 2018
Time: 2:00 p.m. ET
Location: Holmes I/II (4th fl.), Lotte New York Palace Hotel, New York, NY
A live webcast of the presentation will be available by visiting the Investors section of Radius’ website at View Source A replay of the webcast will be archived on Radius’ website for 30 days following the presentation.

CD5CAR

CD5-directed chimeric antigen receptor engineered T-cells are engineered to express an anti-CD5scFV antibody domain. This autologous CAR derived from a patient’s own blood cells is in development for T-cell acute lymphoblastic leukemia. CD5CAR has been granted Orphan Drug Designation by the US Food and Drug Administration for the treatment of T-cell Acute Lympocytic Leukemia.

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