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ALKS Settles Patent Suit, Once-Monthly Contraceptive In The Works, NBIX On Watch

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Today's Daily Dose brings you news about financial results of Neurocrine, PerkinElmer, Medpace and Vapotherm; resolution of VIVITROL patent suit and development of a new once-monthly oral contraceptive.

Read on...

Alkermes plc (ALKS) and Amneal Pharmaceuticals LLC have resolved a patent suit over VIVITROL.

VIVITROL is Alkermes' drug for the treatment of opioid overdose whose patent expires in 2029.

Following the resolution of the patent suit, Alkermes has granted Amneal the non-exclusive right to market a generic formulation of VIVITROL in the U.S. beginning sometime in 2028 or earlier under certain circumstances. Additional terms of the agreement are confidential.

The annual net sales of VIVITROL were $302.6 million in 2018 compared to $269.3 million in 2017.

ALKS closed Monday's trading at $21.86, up 6.32%.

Lyndra Therapeutics, a privately-held company, is currently designing and building a new once-monthly oral contraceptive. The program is being funded by a $13 million grant from the Bill & Melinda Gates Foundation.

The once-monthly oral contraceptive would provide women with a discreet, non-invasive option to support their family planning, according to Lyndra.

A monthly contraceptive administered as an injection by the name Lunelle was approved by the FDA in 2000. However, it was pulled from the market by its manufacturer Pharmacia in 2003 and is no longer available in the U.S.

Medpace Holdings Inc (MEDP) has reported strong financial results for the second quarter ended June 30, 2019.

Medpace is a clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries.

Adjusted net income for the second quarter of 2019 increased to $30.4 million or $0.81 per share from $22.4 million or $0.61 million in the year-ago quarter. Revenue for the recent second quarter rose to $214.1 million from $170.1 million in the comparable prior-year period.

Looking ahead to full-year 2019, the Company expects adjusted net income to be in the range of $105.7 million to $109.7 million, and revenue to be in the range of $840.0 million to $860.0 million. Last year, adjusted net income was $95.5 million and revenue was $704.6 million.

MEDP closed Monday's trading at $67.68, up 6.15%.

Neurocrine Biosciences Inc. (NBIX) has reported stellar revenue for the quarter ended June 30, 2019.

Total revenues for the three months ended June 30, 2019, was $183.6 million compared to $96.9 million in the year-ago period, thanks to growing sales of INGREZZA, the first drug approved to treat adults with tardive dyskinesia.

For the second quarter of 2019, the Company reported net income of $51.3 million or $0.54 per share, compared to a net loss of $5.9 million or $0.07 per share for the same period in 2018.

The Company's New Drug Application for Opicapone, proposed for use as an adjunctive therapy to levodopa/carbidopa in patients with Parkinson's disease experiencing OFF episodes, is under FDA review, with a decision expected on April 26, 2020.

An adaptive, Phase II proof-of-concept study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of NBI-74788 in pediatric patients with classic Congenital Adrenal Hyperplasia is underway.

The Company plans to submit an NDA for Elagolix in the treatment of uterine fibroids in 2019.

NBIX closed Monday's trading at $86.97, down 0.58%.

PerkinElmer Inc. (PKI) has reported mid-single-digit organic revenue growth and double-digit adjusted EPS growth for the second quarter ended June 30, 2019.

On an adjusted basis, earnings per share from continuing operations for the second quarter of 2019 was $1.00 compared to $0.91 in the second quarter of 2018. Adjusted revenue for the recent second quarter increased to $722.7 million from $703.6 million in the second quarter of 2018.

For the full-year 2019, the Company has reiterated its non-GAAP adjusted earnings per share of $4.02 to $4.07.

PKI closed Monday's trading at $95.34, up 0.33%.

Vapotherm Inc. (VAPO), a global medical technology company, has reported a 13.5% increase in second-quarter revenue over the prior-year period.

The company generates revenue primarily from sales of proprietary Precision Flow systems, which includes capital units and single-use disposables.

Revenue for the second quarter of 2019 was $12.0 million compared to $10.56 million in the year-ago period.

For the third quarter of 2019, the Company has forecast revenue in the range of $11.0 million to $11.4 million, an anticipated year-over-year increase of between 17% and 21%. For fiscal 2019, the Company continues to expect revenue in the range of $49.0 million and $51.0 million, an anticipated year-over-year increase of between 16% and 20%.

Vapotherm ended June 30, 2019, with cash and cash equivalents of $46.1 million.

VAPO closed Monday's trading at $19.20, down 2.64%.

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