08.08.2019 11:23:05

DERM On Watchlist, FDA Panel Nod For GILD, So Long, CVRS And AVDR

(RTTNews) - Today's Daily Dose brings you news about the acquisition of Corindus and Avedro; FDA panel recommending approval of Gilead's Descovy; and stellar results of Hanger and Dermira.

Read on…

Corindus Vascular Robotics (CVRS), a developer of precision vascular robotics, is all set to be acquired by Siemens Healthineers AG for $4.28 per share in cash, representing an aggregate purchase price of approximately $1.1 billion.

The transaction has been approved by the Board of Directors of Corindus and is expected to close in the fourth quarter of 2019.

CVRS closed Wednesday's trading at $2.42, down 4.72%.

Dermira Inc. (DERM) has reported QBREXZA cloth net product sales of $8.1 million in the second quarter of 2019, more than triple the number in the first quarter. QBREXZA is a topical anticholinergic contained in a single-use, pre-moistened, medicated cloth for the treatment of primary axillary hyperhidrosis (excessive underarm sweating) in adults and children 9 years of age and older. It was approved by the FDA last June.

For the full year 2019, net product sales of QBREXZA are expected to be in the low-$30 million range.

DERM closed Wednesday's trading at $7.99, up 0.38%.

The FDA panel has recommended approval of Gilead Sciences Inc.'s (GILD) Descovy for the proposed indication of pre-exposure prophylaxis (PrEP) in men and transgender women who have sex with men. The panel voted 16 to 2 in favor of approval of Descovy for the proposed indication.

Descovy is currently indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older.

The drug is a combination pill of tenofovir alafenamide (TAF), marketed as Vemlidy, plus emtricitabine (FTC), marketed as Emtriva.

Currently, the only drug approved for HIV pre-exposure prophylaxis is Truvada, which is also from the stable of Gilead.

Descovy brought in global annual sales of $1.58 billion in 2018 compared to $1.22 billion in 2017.

GILD closed Wednesday's trading at $63.88, down 0.16%.

Glaukos Corp. (GKOS) is all set to acquire Avedro Inc. (AVDR) in an all-stock transaction.

The transaction is expected to be completed in the fourth quarter of 2019.

Separately, the Company announced financial results for the second quarter ended June 30, 2019.

Net loss in the second quarter of 2019, was $6.3 million or $0.17 per share compared to a net loss of $5.4 million or $0.15 per share in the second quarter of 2018. Net sales rose 36% in the second quarter of 2019 to $58.6 million from $43.2 million in the same period in 2018.

Looking ahead to full-year 2019, the Company now expects net sales to be in the range of $226 million to $231 million compared to its prior outlook range of $225 million to $230 million. Net sales in 2018 were $181.3 million.

The updated guidance does not include the impact of the pending acquisition of Avedro.

GKOS closed Wednesday's trading at $73.10, down 4.22%.

Hanger Inc. (HNGR), a provider of orthotic and prosthetic patient care services and solutions, has reported better-than-expected earnings and revenue for the second quarter ended June 30, 2019.

On an adjusted basis, non-GAAP net income in the recent second quarter was $13.4 million or $0.35 per share compared to $10.53 million or $0.28 per share in the year-ago quarter. Net revenue for the recent second quarter jumped to $281 million from $266.9 million in the comparable quarter of 2018.

Analysts polled by Thomson Reuters were expecting earnings of $0.28 per share on revenue of $276.3 million in the second quarter of 2019.

Looking ahead, Hanger has reaffirmed its full-year 2019 net revenue outlook range between $1.075 billion and $1.105 billion.

HNGR closed Wednesday's trading at $15.62, down 5.39%.

Senseonics Holdings Inc. (SENS) has reported a narrower loss and higher revenue for the quarter ended June 30, 2019.

Net loss narrowed to $31.1 million or $0.17 per share in the second quarter of 2019 from $32.5 million or $0.23 per share in the second quarter of 2018. Revenue was $4.6 million for the second quarter of 2019 compared to $3.6 million for the second quarter of 2018.

Looking ahead, the Company expects revenue for the full year 2019 to be in the range of $25 to $30 million. Revenue in 2018 was $18.9 million.

SENS closed Wednesday's trading at $1.08, up 4.85%.

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Aktien in diesem Artikel

Gilead Sciences Inc. 87,64 -1,64% Gilead Sciences Inc.
Glaukos Corp 134,00 0,00% Glaukos Corp
Senseonics Holdings Inc 0,30 5,40% Senseonics Holdings Inc