endo international plc (ENDP) Key Developments
Endo International plc Appoints Paul Campanelli to Lead Generics Business and Join Executive Leadership Team
May 18 15
Endo International plc and Par Pharmaceutical Holdings Inc. announced that they have entered into a definitive agreement under which Endo will acquire privately-held Par from TPG in a transaction valued at $8.05 billion, including assumption of Par debt. Par CEO Paul Campanelli to join Endo to lead generics business and join executive leadership team.
Endo International plc, Par Pharmaceutical Holdings, Inc. - M&A Call
May 18 15
To discuss the acquisition of Par Pharmaceutical
Endo International Seeks Acquisitions
May 18 15
Endo International plc (NasdaqGS:ENDP) will consider acquisitions. Endo said it is seeking a capital structure that will allow for more acquisitions in the future.
Endo Pharmaceuticals Inc Receives U.S. Food and Drug Administration Approval for Label Update for XIAFLEX
May 15 15
Endo Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a label update for XIAFLEX® (collagenase clostridium histolyticum or CCH) for the treatment of adult Dupuytren's contracture (DC) patients with a palpable cord. The updated label now includes a long-term, observational study demonstrating the rate of recurrence for up to 5 years after successful treatment with XIAFLEX®, and the efficacy and safety of retreatment in patients with recurrent DC. DC is a chronic condition affecting the hand in which abnormal buildup of collagen can cause the fingers to bend and be drawn in toward the palm. It is a rare genetic condition affecting up to 7% of adults in the United States. An estimated 20% to 60% of cases may recur following treatment. The long-term, observational study (referred to as Study 4 in the product label) evaluated the recurrence of contracture and safety at Year 2 to Year 5 in patients who had received up to 8 single injections of XIAFLEX® in a previous open-label or double-blind with open-label extension study. A total of 645 patients were enrolled, of whom 30% discontinued the study. Recurrence was assessed in successfully treated joints (i.e., a reduction in contracture to 5 degrees or less 30 days after the last injection of XIAFLEX®) and was defined as an increase in joint contracture by at least 20 degree in the presence of a palpable cord, or the joint underwent medical or surgical intervention primarily to correct a new or worsening DC in that joint. Following successful treatment, the probability of remaining recurrence free was 80% at Year 2 and 50% at Year 5. The second study (referred to as Study 5 in the product label) evaluated a subset of patients from Study 4 for a\ joint that was previously successfully treated but had recurrence. Patients in this study received up to 3 injections of XIAFLEX®. Of the 91 patients eligible for the study, 52 enrolled. In the study, 65% of recurrence in the metacarpophalangeal (MP) joints (i.e., the knuckle between the hand and the finger) and 45% of recurrence in the proximal interphalangeal (PIP) joints (i.e., middle joint of a finger) achieved clinical success after retreatment. No new safety signals were identified among subjects who were retreated with XIAFLEX®.
Endo International plc Announces Unaudited Consolidated Earnings Results for the First Quarter Ended March 31, 2015; Revises Earnings Guidance for the Year Ending December 31, 2015; Announces Impairment Charges for the First Quarter of 2015
May 11 15
Endo International plc announced unaudited consolidated earnings results for the first quarter ended March 31, 2015. For the quarter, the company reported revenues of $714 million, a 52% increase compared to first quarter 2014 revenues of $471 million. Income from continuing operations was $150 million compared to a first quarter 2014 reported loss from continuing operations of $47 million. Adjusted income from continuing operations was $207 million, a 91% increase compared to first quarter 2014 adjusted income from continuing operations of $108 million. Diluted EPS from continuing operations was $0.85 compared to first quarter 2014 reported loss per share from continuing operations of $0.37. Adjusted diluted earnings per share from continuing operations was $1.17 compared to first quarter 2014 adjusted diluted earnings per share from continuing operations of $0.75. Operating income was $45.7 million compared with $21.9 million a year ago. Non-GAAP operating income was $317.6 million compared with $179.6 million a year ago. Loss from continuing operations before income tax was $16.4 million compared with $34.7 million a year ago. Non-GAAP income from continuing operations before income tax was $247.8 million compared with $138.6 million a year ago. Net loss attributable to the company was $75.7 million compared with $47.4 million a year ago. Net loss attributable to the company was $75.7 million or $0.43 per diluted share compared with $436.9 million or $3.41 per diluted share a year ago. Non-GAAP net income attributable to the company was $228.0 million or $1.29 per diluted share compared with $134.1 million or $0.92 per diluted share a year ago. Net cash used in operating activities was $89.8 million compared with $246.9 million a year ago. Purchases of property, plant and equipment, net was $17.2 million compared with $20.8 million a year ago.
For the full twelve months ending December 31, 2015, the company estimates total revenue to be between $2.90 billion and $3.00 billion; reported (GAAP) diluted earnings per share (EPS) from continuing operations now expected to be between $1.70 and $1.90 compared to $2.73 and $2.93 previously; and adjusted diluted EPS from continuing operations now expected to be between $4.40 and $4.60 compared to $4.35 and $4.55 previously. The company estimates adjusted gross margin of between 64% and 65%, adjusted interest expense of approximately $310 million and adjusted effective tax rate of between 13% and 14%.
The company announced asset impairment charges of $7,000,000 for the first quarter ended March 31, 2015.