Apr 29, 2016

Posted by in Biotech Stocks | 0 Comments

Stocks in Queue: Celldex Therapeutics Inc (NASDAQ:CLDX), Amgen Inc (NASDAQ:AMGN), Keryx Biopharmaceuticals (NASDAQ:KERX)

Stocks in Queue: Celldex Therapeutics Inc (NASDAQ:CLDX), Amgen Inc (NASDAQ:AMGN), Keryx Biopharmaceuticals (NASDAQ:KERX)

Celldex Therapeutics Inc (NASDAQ:CLDX) surged +2.70% and ended at $4.19. The total traded volume was 4.25 million shares and market capitalization arrived at $426.16 million. The stock has a 52-week high price of $29.94 and its 52-week low was recorded at $2.96, while during last trade its minimum price was $3.95 and it gained the highest price of $4.46.

Celldex Therapeutics Inc (NASDAQ:CLDX) on April 27, 2016 announced that it has initiated an open-label Phase 1/2 safety and tolerability study of glembatumumab vedotin in patients with unresectable stage IIIB or IV, gpNMB-expressing, advanced or metastatic squamous cell carcinoma (SCC) of the lung, who have progressed on prior platinum-based chemotherapy. Glembatumumab vedotin is a fully human monoclonal antibody-drug conjugate (ADC) that targets gpNMB, a protein overexpressed by multiple tumor types, including SCC of the lung, where approximately 85 percent of patients overexpress the marker. Overexpression of gpNMB has been shown to promote the invasion and metastasis of cancer and has been associated with poor clinical outcome. Celldex has entered into a collaborative relationship with PrECOG, LLC, which represents a research network established by the Eastern Cooperative Oncology Group (ECOG), and PrECOG, LLC will conduct the study.

Glembatumumab vedotin is currently being evaluated in patients with metastatic triple negative breast cancers that overexpress gpNMB in the registrational METRIC study, as well as in a Phase 2 study in patients with advanced melanoma who have progressed after at least one checkpoint inhibitor therapy and, if applicable, BRAF- or MEK-targeted therapy. It has been previously evaluated in a Phase 2 study in advanced breast cancer (the EMERGE study), a Phase 1/2 study in advanced breast cancer and a Phase 1/2 study in patients with unresectable stage III or IV melanoma. Also, Celldex and the National Cancer Institute (NCI) have entered into a Cooperative Research and Development Agreement (CRADA) under which the NCI is sponsoring two studies of glembatumumab vedotin—one in uveal melanoma and one in pediatric osteosarcoma. Both studies are currently open to enrollment.

Amgen Inc (NASDAQ:AMGN) reported the decrease of -0.27% to close at $160.56 with the overall traded volume of 3.35 million shares. Its market capitalization on last close reached to $119.06 billion. Its beta value stands at 0.82 times. The company has the total of 752.09 million outstanding shares. Its intraday-low price was $159.36 and its hit its day’s highest price at $163.68.

Amgen Inc (NASDAQ:AMGN) on April 28, 2016 announced financial results for the first quarter of 2016. Key results include:

  • Total revenues increased 10 percent versus the first quarter of 2015 to $5,527 million, with 7 percent product sales growth driven by Enbrel® (etanercept), Prolia® (denosumab), Aranesp® (darbepoetin alfa), Neulasta® (pegfilgrastim), Kyprolis® (carfilzomib) and XGEVA® (denosumab).
  • Adjusted EPS grew 17 percent versus the first quarter of 2015 to $2.90 driven by higher revenues and higher operating margins.
  • Adjusted operating income increased 17 percent to $2,859 million and adjusted operating margin improved by 4.4 percentage points to 54.6 percent.
  • GAAP EPS were $2.50 compared to $2.11 and GAAP operating income was $2,402 million compared to $2,022 million.
  • Free cash flow was $1.8 billion compared to $1.4 billion in the first quarter of 2015 driven by higher revenues and higher operating income.

Keryx Biopharmaceuticals (NASDAQ:KERX) moved up +3.54% to settle at $5.26. Its total traded volume during last trading session was 4.64 million shares. The overall market worth of this company is about $558.81 million. The 52 week range of the stock remained $2.80 – $11.40, while its day’s lowest price was $4.66 and its hit its day’s highest price at $5.89. The beta of this stock currently stands at 4.03.

Keryx Biopharmaceuticals (NASDAQ:KERX) on April 28, 2016 announced its financial results for the first quarter ended March 31, 2016.

Total revenues for the quarter ended March 31, 2016 were approximately $6.8 million, compared with $1.2 million during the same period in 2015. Total revenues for the quarter consisted of Auryxia net U.S. product sales of $5.6 million, and license revenue of $1.2 million associated with royalties received on ferric citrate net sales from Keryx’s Japanese partner.

Cost of goods sold for the quarter ended March 31, 2016 was $1.1 million or 19 percent of Auryxia net U.S. product sales, as compared with $0.1 million or 18 percent during the same period in 2015.

Research and development expenses for the quarter ended March 31, 2016 were $7.6 million compared with $9.6 million during the same period in 2015. The decrease was primarily due to a decrease in costs associated with the company’s recently completed Phase 3 clinical trial evaluating ferric citrate for the treatment of IDA in adults with stage 3-5 non-dialysis dependent CKD.

Selling, general and administrative expenses for the quarter ended March 31, 2016 were $20.8 million, as compared with $18.9 million during the same period in 2015. The increase was primarily related to incremental costs associated with hiring and onboarding of Keryx’s expanded field team.

Net loss for the first quarter ended March 31, 2016 was $41.0 million, or $0.39 per share, compared to a net loss of $27.7 million, or $0.28 per share, for the comparable quarter in 2015. The company’s net loss for the quarter ended March 31, 2016 includes $15.7 million in non-cash interest expense related to amortization of the debt discount on its convertible senior notes, as well as a $2.0 million non-cash charge related to the increase in fair value of the derivative liability that was recorded in connection with the issuance of the convertible senior notes.

 

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