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Mallinckrodt (MNK) Reports Second Quarter 2017 Results



8/4/2017 8:23:12 AM

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SAN DIEGO, Aug. 3, 2017 /PRNewswire/ -- Neurocrine Biosciences, Inc. (NASDAQ:NBIX) today announced its financial results for the quarter ended June 30, 2017, highlighted by the successful regulatory approval and commercial launch of INGREZZA® (valbenazine) capsules in tardive dyskinesia, as well as other recent progress on its pipeline.

"We are very pleased with the initial months of INGREZZA's launch and are encouraged by the positive feedback we are receiving from patients, physicians, and caregivers," said Kevin Gorman, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "We successfully deployed our sales force on May 1st and activated our patient and prescriber support system, INBRACE; we are continuing to expand awareness of INGREZZA among healthcare professionals through multiple initiatives ranging from symposia at major medical meetings to local speaker programs; we are working with payors to make INGREZZA available to eligible patients; and we continue to see strong growth in prescription volume. Finally, we remain as committed as ever to our science and to advancing our robust pipeline."

Financial Results

Neurocrine reported net product sales of $6.3 million for the three months ended June 30, 2017. No similar net product sales were reported for the comparable period of 2016. INGREZZA was made available for commercial distribution on May 1, 2017, and the Company recognizes revenue using a sell-in methodology when products are delivered to select pharmacies or distributors.

For the second quarter of 2017, the Company reported a net loss of $60.0 million, or $0.68 loss per share, compared to a net loss of $40.3 million, or $0.46 loss per share, for the same period in 2016. For the six months ended June 30, 2017, the Company reported a net loss of $138.3 million, or $1.58 loss per share, as compared to a net loss of $59.5 million, or $0.69 loss per share, for the first half of last year.

Research and development (R&D) expenses were $21.9 million during the second quarter of 2017 compared to $26.9 million for the same period in 2016. The decrease in R&D expense is principally due to the completion of pivotal studies for INGREZZA. For the six months ended June 30, 2017, R&D expenses were $73.8 million, compared to $50.8 million for the same period last year. This increase is primarily due a $30 million payment in the first quarter of 2017 from the Company's entering into an exclusive licensing agreement with BIAL Portela & CA, S.A. (BIAL) for the development and commercialization of opicapone in the United States and Canada, which was expensed as in-process R&D.

Selling, general and administrative (SG&A) expenses increased to $41.7 million for the second quarter of 2017 from $15.0 million for the second quarter of 2016.  For the six months ended June 30, 2017, SG&A expenses were $69.7 million, compared to $26.9 million for the first half of 2016. The increase in SG&A expense is primarily due to commercialization activities for INGREZZA and, in particular, the on-boarding of our full sales organization.

The Company's balance sheet at June 30, 2017, reflected total assets of $754.1 million, including cash, investments and receivables of $739.6 million, compared with total asset balances at March 31, 2017 and December 31, 2016 of $289.4 million and $365.1 million, respectively. These assets include the $502.8 million raised, net of expenses, via the Company's convertible notes offering which closed on May 2, 2017. 

Pipeline Highlights

INGREZZA (valbenazine) Update

INGREZZA received U.S. Food and Drug Administration (FDA) approval on April 11, 2017, becoming the first and only medicine approved in the United States for adults with tardive dyskinesia. Full commercial efforts began on May 1, 2017. On June 14, 2017, the Company submitted a supplemental New Drug Application (NDA) with the FDA for the approval of 80 mg capsules of INGREZZA for the treatment of tardive dyskinesia. Pending notification of the acceptance by the FDA of the supplemental NDA, the Company has been advised that the Prescription Drug User Fee Act (PDUFA) goal date is October 14, 2017. In July 2017, Neurocrine completed the INGREZZA roll-over study for those patients who had previously completed one year of dosing in either the Kinect 3 or Kinect 4 study.   

In March 2015, the Company announced that it has entered into an exclusive collaboration and licensing agreement for the development and commercialization of INGREZZA in Japan and other select Asian markets with Mitsubishi Tanabe Pharma Corporation (Mitsubishi Tanabe). Mitsubishi Tanabe expects to initiate a pivotal trial of INGREZZA in Asia for the treatment of tardive dyskinesia and pay $15 million in related milestones in the third quarter of 2017.

INGREZZA is also being investigated in Tourette syndrome for both adult and pediatric patients.

The T-Force GREEN study was a randomized, double-blind, placebo-controlled, multi-dose, parallel-group Phase II study that enrolled 94 children and adolescents.

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Read at BioSpace.com


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