Apr 12, 2016

Posted by in Biotech Stocks | 0 Comments

Momentum Stocks: MannKind Corporation (NASDAQ:MNKD), Gilead Sciences Inc (NASDAQ:GILD), Baxalta Inc (NYSE:BXLT)

Momentum Stocks: MannKind Corporation (NASDAQ:MNKD), Gilead Sciences Inc (NASDAQ:GILD), Baxalta Inc (NYSE:BXLT)

MannKind Corporation (NASDAQ:MNKD) surged +24.59% and ended at $1.52. The total traded volume was 10.74 million shares and market capitalization arrived at $812.15 million. The stock has a 52-week high price of $7.32 and its 52-week low was recorded at $0.64, while during last trade its minimum price was $1.27 and it gained the highest price of $1.56.

MannKind Corporation (NASDAQ:MNKD) on March 14, 2016 reported financial results for the fourth quarter and full year ended December 31, 2015.

For the fourth quarter of 2015, research and development expenses decreased 64.8%, from $17.6 million to $6.2 million, reflecting effects of our restructuring measures taken in 2015 and the transition from development to commercial activities.  General and administrative costs declined 33.6%, from $12.5 million to $8.3 million, mainly due to a decrease in non-cash stock compensation expense.  Sales of Afrezza continued to be lower than expected during the fourth quarter of 2015, culminating in a decision by Sanofi on January 4, 2016 to return the Afrezza rights to MannKind after a notice period, all of which impacted the value and recoverability of long-lived assets in accordance with accounting guidance.  As a result, non-cash impairment charges of $206.6 million were recorded for the fourth quarter of 2015, of which $140.4 million related to impairment of fixed assets and $66.2 million related to loss on future purchase commitments, primarily for insulin.  No such impairment charge was recognized in 2014.  Product manufacturing costs for the fourth quarter of 2015 were $51.8 million related to under absorbed labor and overhead and inventory write-offs. We did not recognize any product manufacturing costs in the fourth quarter of 2014 as we had not yet commenced commercialization of Afrezza.

For the full year 2015, our total operating expenses, excluding fixed asset impairment and loss on purchase commitments, were $138.1 million compared to $179.6 million for the full year 2014, a decrease of 23.1%. Total research and development costs for 2015 were $29.7 million compared $100.2 million for 2014, a decrease of 70.4%, primarily due to decreased development expenses resulting from the shift to commercial production of Afrezza, decreased clinical trial-related expenses and the effects of restructuring measures, in addition to reduced non-cash stock compensation expense resulting from the non-recurring achievement of performance and modification events in 2014 and the first quarter of 2015. General and administrative expenses for 2015 were $41.0 million compared to $79.4 million in 2014, a decrease of 48.4%, primarily due to reduced non-cash stock compensation expense resulting from the modification and achievement of performance-based awards in 2014 and in the first quarter of 2015 and the effects of restructuring measures, in addition to the non-recurrence of professional fees incurred in the third quarter of 2014 associated with the entry into the Sanofi License Agreement.  Product manufacturing costs for 2015 were $67.4 million related to under absorbed labor and overhead and inventory write-offs. We did not recognize any product manufacturing costs in 2014 as we had not yet commenced commercialization of Afrezza.

Gilead Sciences Inc (NASDAQ:GILD) reported the decrease of -0.27% to close at $95.83 with the overall traded volume of 8.80 million shares. Its market capitalization on last close reached to $130.52 billion. Its beta value stands at 1.03 times. The company has the total of 1.35 billion outstanding shares. Its intraday-low price was $95.74 and its hit its day’s highest price at $97.05.

Gilead Sciences Inc (NASDAQ:GILD) and Nimbus Therapeutics, LLC announced on April 4, 2016, that the companies have signed a definitive agreement under which Gilead will acquire Nimbus Apollo, Inc., a wholly-owned subsidiary of Nimbus Therapeutics, and its Acetyl-CoA Carboxylase (ACC) inhibitor program. Nimbus Therapeutics will receive an upfront payment of $400 million, with the potential to receive an additional $800 million in development-related milestones over time.

The Nimbus Apollo program includes the lead candidate NDI-010976, an ACC inhibitor, and other preclinical ACC inhibitors for the treatment of non-alcoholic steatohepatitis (NASH), and for the potential treatment of hepatocellular carcinoma (HCC) and other diseases. NDI-010976 was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) in February 2016 and Phase 1 data for the compound will be presented next month during an oral session at The International Liver Congress 2016, the annual meeting of the European Association for the Study of the Liver (EASL).

NASH is a serious liver disease resulting from metabolic dysfunction associated with steatosis (fat within the liver) that can lead to inflammation, hepatocellular injury, progressive fibrosis and cirrhosis. Affecting up to 15 million people in the United States, NASH is expected to become the leading indication for liver transplantation by 2020. ACC inhibitors target a central cause of the disease – reducing aberrant lipid-derived signaling that can result in steatosis, inflammation and fibrosis.

Baxalta Inc (NYSE:BXLT) moved up +0.22% to settle at $40.35. Its total traded volume during last trading session was 5.80 million shares. The overall market worth of this company is about $27.55 billion. The 52 week range of the stock remained $29.83 – $42.38, while its day’s lowest price was $40.06 and its hit its day’s highest price at $40.67.

Baxalta Inc (NYSE:BXLT) on April 4, 2016 announced that the Ministry of Health, Labour and Welfare in Japan approved ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated], an extended circulating half-life recombinant Factor VIII (rFVIII) treatment, for patients 12 years and older with hemophilia A.

ADYNOVATE is built on ADVATE [Antihemophilic Factor (Recombinant)], the world’s most widely used FVIII treatment for hemophilia A with more than 12 years of patient experience. ADYNOVATE leverages proprietary pegylation technology2 designed to extend the time FVIII is available in the body. The technology reduces the speed at which ADYNOVATE is cleared from the blood, resulting in increased circulating half-life.

The approval was based on positive results of a Phase 3, prospective, global, multi-center, open label, non-randomized study in patients 12 to 65 years of age with hemophilia A. The study found that previously-treated patients in a twice-weekly prophylaxis arm had a 95 percent reduction in the median overall annualized bleed rate (ABR) compared to those treated on-demand [1.9 vs. 41.5, respectively]. During the study, nearly 40 percent (n=120) of prophylaxis-treated patients experienced zero bleeds.No patients developed inhibitors to the treatment; the most common adverse reactions (≥1 percent of subjects) were headache and nausea.

 

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