Endo International plc – Ordinary Shares (NASDAQ:ENDP) reported certain preliminary data for the quarter closed September 30, 2017, including anticipated: (i) revenues of around $785 million; (ii) recorded (GAAP) net loss attributable to company of about $100 million; (iii) adjusted EBITDA from continuing operations of about $370 million; (iv) recorded (GAAP) loss per share of approximately $0.45 from continuing operations; and (v) adjusted diluted EPS of approximately $0.85 from continuing operations.
The details
Endo affirmed that for the year closing December 31, 2017, the firm anticipates revenues to come between $3.38 billion and $3.53 billion. The firm further projects adjusted EBITDA and adjusted diluted EPS to be at the upper end of the FY2017 guidance ranges issued in August. It will issue further details on its complete FY2017 financial projection and assumptions when it announces third-quarter 2017 earnings in November.
Additionally, Endo reported the firm’s intention to aggressively protect and defend its VASOSTRICT® intellectual property and product franchise, including seeking to avert the not permitted, non-sterile-to-sterile bulk compounding of vasopressin via a previously reported case submitted by certain of its subsidiaries against the U.S. FDA on October 26, 2017.
The firm is not aware of any not permitted, non-sterile-to-sterile compounding facilities presently distributing or selling a vasopressin injection offering. VASOSTRICT® remains the only FDA-permitted vasopressin injection offering intended to increase blood pressure in people with vasodilatory shock who remain hypotensive despite catecholamines and fluids.
During the Q3 2017, the USPTO issued to Endo’s Par Pharmaceutical operating firm three new patents pertaining to VASOSTRICT® 20 units/mL. The PTO released U.S. Patent, all of which have expiration dates going to January 30, 2035. These three patents have been marked in the FDA Approved Drug Offerings with Therapeutic Equivalence Evaluations, commonly termed as the Orange Book.
VASOSTRICT® is contraindicated in people with hypersensitivity or known allergy to 8-L-arginine vasopressin or chlorobutanol. Applications in people with impaired cardiac response may deteriorate cardiac output.
