Premarket Biotech Digest – Teva, MannKind, Quidel, Applied DNA Sciences Reported Earnings

Top Pick of the Day: TEVA

Teva Pharmaceutical Industries (TEVA) announced its first quarter results. The company reported that its revenue for the quarter was up 17 percent at $5.63 billion, lagging behind the consensus estimate of $5.68 billion. Its earnings per share (EPS) slipped to $1.06 excluding exceptional items from $1.20 a year earlier, surpassing consensus estimate of $1.03 per share. The global sales of its best-selling multiple sclerosis drug Copaxone fell 4 percent in the quarter to $970 million. The company stock reacted positively to the announcement and it gained over 2 percent in its previous trading session. The stock has lost 11 percent of its value this year so far.

Focus Ticker: MNKD

MannKind Corporation (MNKD) reported its first quarter results. The company loss for the quarter stood at $16.3 million while its revenue was reported at $3 million. On per share basis, the company’s adjusted loss stood at $0.22. The company’s cost of goods sold was $2.5 million in the first quarter of 2017 compared to $5.2 million in the first quarter of 2016, a decrease of approximately $2.7 million or 52%. MannKind also reported that it incurred research and development expenses of $3.1 million in the first quarter of 2017 compared to $5.1 million in the first quarter of 2016, a decrease of $2.0 million or 39%. The company stock lost 20 percent of its value in response, taking its 12 months losses to 80 percent.

Sector News

Boston Scientific (BSX) reported results from the largest post-market real-world study for its Subcutaneous Implantable Defibrillator (S-ICD) System. The post-market real-world study  showed a 98.7% success rate. S-ICD therapy effectively stopped life-threatening heart arrhythmias in 98.7% of evaluated patients. The 30-day complication rate was 3.8%.

STAAR Surgical (STAA) announced that its next-generation lens, EVO+ Visian ICL (EDOF) Optic has received CE mark. The company plans to carry out beta market launch through a select group of physicians. The lens is  surgically implanted between the iris and natural lens where it works in harmony with the patient's eye to correct/reduce hyperopia (farsightedness) and myopia (nearsightedness).

Approvals

Quidel (QDEL) reported that the it has received 510 (k) clearance for its molecular diagnostic test for Clostridium difficile (C. diff) infection performed on its Solana bench top analyzer. The assay can generate a result in 35 minutes. It is based on the Helicase-Dependent Amplification technology.

Xencor (XNCR) announced that the FDA has designated its CD19-targeting monoclonal antibody XmAb5871 an Orphan Drug for the treatment of IgG4-Related Disease, a newly defined fibro-inflammatory autoimmune disorder. There are no approved therapies for the condition. Phase 2-stage XmAb5871 specifically targets a receptor that inhibits B-cell function called FcyRIIb.

Deals and Collaborations

Corbus Pharmaceuticals (CRBP) announced that it has its last patient enrolled for Phase 2 clinical trial assessing anabasum (formerly JBT-101) for the treatment of skin-predominant dermatomyositis, a rare progressive autoimmune disorder characterized by painful skin abnormalities.
Aimmune Therapeutics (AIMT) announced that it has enrolled its first patient for  Phase 3 clinical trial, RAMSES, assessing lead product candidate AR101 for the treatment of peanut allergy in a real-world setting. The study follows the same up-dosing and maintenance protocol as the ongoing Phase 3 PALISADE trial. 

Earnings

Applied DNA Sciences (APDN) reported its second quarter loss at $3.4 million. On per share basis, the loss stood at $0.13. The company’s revenue for the quarter stood at $905,373 while its adjusted revenue was at $905,000.

InspireMD Inc. (NSPR) reported its first quarter revenue at $569,000, compared to $563,000 during the same period in 2016. Total operating expenses for the quarter ended March 31, 2017 were $2,478,000, an increase of 18.2% compared to $2,096,000 for the same period in 2016.  Net loss for the quarter ended March 31, 2017 totaled $2,559,000, or $0.81 per basic and diluted share, compared to a net loss of $2,252,000, or $7.00 per basic and diluted share, in the same period in 2016.