- Company receives USFDA approval for Valbenazine Capsules
- Revenue from operations at Rs. 62,075 mn, up 21% YoY
- Research & Development (R&D) investments for the quarter stood at Rs. 3,925 mn (6.3% of revenues)
NE BUSINESS BUREAU
AHMEDABAD, AUGUST 11
Zydus Lifesciences Limited on Friday said its consolidated net profit increased 31 per cent year on year to Rs 1,420 crore in the first quarter ended June 2024 on the back of robust sales.
The drug maker had reported a net profit of Rs 1,087 crore in the April-June quarter of last fiscal.
Revenue from operations rose to Rs 6,207 crore in the period under review as compared to Rs 5,140 crore in the June quarter of FY24, Zydus Lifesciences said in a statement.
“Sustained growth momentum across our businesses along with enhanced profitability drove our strong Q1 performance,” Zydus Lifesciences Managing Director Sharvil Patel said.
Execution success of company’s differentiated pipeline in the US and outperformance of India geography business were particularly noteworthy, he added.
“We are on course to achieve our growth aspirations for FY25 and are committed to investing in sustainable growth initiatives and innovative solutions for the future,” Patel said.
The company said its India sales stood at Rs 2,212 crore in the June quarter, up 15 per cent, as compared to Rs 1,921 crore in the year-ago period.
The US formulation sales stood at Rs 3,093 crore in first quarter, up 26 per cent year on year as against Rs 2,454 crore in the year-ago period.
Q1 FY25 Consolidated Financial Results
| Rs. mn | Q1
FY25 |
Q1
FY24 |
% Gr. YoY |
Q4
FY24 |
% Gr. QoQ |
| Revenue from operations | 62,075 | 51,396 | 20.8% | 55,338 | 12.2% |
| EBITDA | 20,840 | 15,053 | 38.4% | 16,305 | 27.8% |
| EBITDA margin (%) | 33.6% | 29.3% | 29.5% | ||
| PBT | 18,997 | 13,292 | 42.9% | 15,470 | 22.8% |
| Net Profit | 14,199 | 10,869 | 30.6% | 11,823 | 20.1% |
Zydus receives USFDA approval for Valbenazine Capsules
Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to market Valbenazine Capsules, 40 mg, 60 mg, and 80 mg (USRLD: Ingrezza Capsules).
Valbenazine Capsules are indicated for the treatment of adults with tardive dyskinesia (uncontrollable movement of the face, tongue, or other body parts).
The drug will be manufactured at the group’s formulation manufacturing facility in Ahmedabad SEZ – II, India.
Zydus was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for Valbenazine Capsules, 40 mg, and 80 mg, and was the first ANDA applicant to submit a substantially complete ANDA with a paragraph IV certification for Valbenazine Capsules, 60 mg.
With this approval, Zydus is eligible for 180 days of shared generic drug exclusivity for Valbenazine Capsules, 40 mg, and 80 mg, and is eligible for 180 days of sole generic drug exclusivity for Valbenazine Capsules, 60 mg.
Valbenazine Capsules had annual sales of USD 1993.6 mn in the United States (IQVIA MAT June 2024).