In the first quarter, Endo International (ENDP) reported revenue of $720.41 million, a YoY (year-over-year) rise of 2.84% and $28.10 million higher than the consensus estimate. The company reported non-generally accepted accounting principles EPS of $0.53 in the quarter, a YoY fall of 20.90% but $0.10 higher than the consensus estimate.
On its first-quarter earnings conference call, Endo International reaffirmed its 2019 guidance of low-double-digit-percentage growth in revenue in its Branded Pharmaceuticals segment YoY. The company also reiterated its guidance of mid to high-teen-percentage growth in revenue for Xiaflex YoY in 2019.
In the first quarter, Branded Pharmaceuticals reported revenue of $204 million, a YoY rise of 2%. Its specialty products business reported revenue of $115 million, a YoY rise of 19% driven mainly by the robust uptake of Xiaflex. Xiaflex reported revenue of $69 million in the first quarter, a YoY rise of 20% due to increased awareness about Peyronie’s disease and Dupuytren’s contracture indications. On the other hand, the established products portfolio within the Branded Pharmaceuticals segment continued to see generic erosion in the first quarter.
Endo International plans to submit a biologics license application to secure FDA approval of collagenase clostridium histolyticum for the treatment of cellulite in the second half of 2019. If it receives FDA approval, the company plans to launch this product in the US market in the second half of 2020.
On its first-quarter earnings conference call, Endo International reaffirmed its 2019 guidance of low-double-digit-percentage revenue growth in its Sterile Injectables segment YoY.
In the first quarter, Sterile Injectables reported revenue of $270 million, a YoY rise of 25%. This performance was driven by the rapid uptake of ertepenam for injection, which was launched in the third quarter, as well as the increased uptakes of VASOSTRICT and ADRENALIN.
Endo International also expects to benefit from the FDA’s decision to remove vasopressin from the 503B bulks list, which made it illegal to sell compounded vasopressin products that included vasopressin not approved by the FDA. Since VASOSTRICT is the only FDA-approved vasopressin, Endo International expects to benefit from this regulatory change.