Latest news with #Prucalopride
Yahoo
30-06-2025
- Business
- Yahoo
The Top 5 Analyst Questions From ANI Pharmaceuticals's Q1 Earnings Call
ANI Pharmaceuticals' first quarter results were marked by substantial top-line growth, but the market responded negatively, with shares falling sharply after the report. Management attributed the quarter's revenue strength to a surge in generics sales, ongoing robust demand for Cortrophin Gel, and increased activity in branded products. CEO Nikhil Lalwani said, 'The first quarter reflected particularly strong performance for our generics business, continued solid demand for Cortrophin Gel, and increased demand for our brands portfolio.' However, margin pressures and near-term challenges in the retina segment weighed on investor sentiment. Is now the time to buy ANIP? Find out in our full research report (it's free). Revenue: $197.1 million vs analyst estimates of $179.6 million (43.4% year-on-year growth, 9.8% beat) Adjusted EPS: $1.70 vs analyst estimates of $1.38 (23% beat) Adjusted EBITDA: $50.75 million vs analyst estimates of $42.4 million (25.7% margin, 19.7% beat) The company lifted its revenue guidance for the full year to $780.5 million at the midpoint from $766 million, a 1.9% increase Management raised its full-year Adjusted EPS guidance to $6.45 at the midpoint, a 2.2% increase EBITDA guidance for the full year is $200 million at the midpoint, above analyst estimates of $195.8 million Operating Margin: 13.3%, down from 14.8% in the same quarter last year Market Capitalization: $1.31 billion While we enjoy listening to the management's commentary, our favorite part of earnings calls are the analyst questions. Those are unscripted and can often highlight topics that management teams would rather avoid or topics where the answer is complicated. Here is what has caught our attention. Gary Nachman (Raymond James) pressed on whether the new pre-filled syringe for Cortrophin Gel could materially expand use and asked about the impact of added sales reps. CEO Nikhil Lalwani said early feedback was positive and that the expanded field force is gaining traction, but no further rep additions are planned for now. Faisal Khurshid (Leerink Partners) sought clarity on commercial access barriers affecting the retina segment, particularly regarding Medicare. Lalwani explained that lack of foundation funding for co-pay support in Q1 reduced access but the company is exploring alternative pathways and expects improvement. Vamil Divan (Guggenheim Securities) asked about the potential impact of upcoming clinical trial results for retina therapies and the significance of Prucalopride exclusivity for generics. Management confirmed that positive trial outcomes could broaden ILUVIEN's use, and that generics revenue will dip post-exclusivity before rebounding. David Amsellem (Piper Sandler) questioned the sustainability of payer dynamics as the Cortrophin category grows and inquired about surprises in the Alimera acquisition. Lalwani asserted that payers value competition in ACTH and expressed confidence in resolving challenges related to the retina portfolio. Ekaterina Knyazkova (J.P. Morgan) probed which indications are driving Cortrophin Gel growth and whether ANI's U.S. manufacturing footprint could be leveraged if tariffs are enacted. Lalwani detailed broad-based growth across specialties and confirmed spare capacity to meet potential tariff-driven demand. In the coming quarters, StockStory analysts will monitor (1) the pace of Cortrophin Gel adoption enabled by the pre-filled syringe and outreach to new prescribers, (2) the recovery in retina segment sales as commercial changes and market access initiatives take effect, and (3) sustained momentum in generics following the expiration of Prucalopride exclusivity. Any developments regarding pharmaceutical tariffs and the ongoing CG Oncology royalty litigation may also influence results. ANI Pharmaceuticals currently trades at $65.50, down from $71.67 just before the earnings. Is the company at an inflection point that warrants a buy or sell? Find out in our full research report (it's free). The market surged in 2024 and reached record highs after Donald Trump's presidential victory in November, but questions about new economic policies are adding much uncertainty for 2025. While the crowd speculates what might happen next, we're homing in on the companies that can succeed regardless of the political or macroeconomic environment. Put yourself in the driver's seat and build a durable portfolio by checking out our Top 5 Strong Momentum Stocks for this week. This is a curated list of our High Quality stocks that have generated a market-beating return of 183% over the last five years (as of March 31st 2025). Stocks that made our list in 2020 include now familiar names such as Nvidia (+1,545% between March 2020 and March 2025) as well as under-the-radar businesses like the once-micro-cap company Kadant (+351% five-year return). Find your next big winner with StockStory today.
Time of India
26-06-2025
- Business
- Time of India
Lupin launches generic chronic constipation treatment drug in US
Pharma major Lupin Ltd on Thursday said it has launched its generic version of Prucalopride tablets used to treat chronic idiopathic constipation in the US market after the recent approval by the country's health regulatory. The Mumbai-based company has launched Prucalopride tablets of strengths 1 mg, and 2 mg in the US, following the recent approval of its abbreviated new drug application (ANDA) from the USFDA, Lupin said in a regulatory filing. These Prucalopride tablets are bioequivalent to Motegrity tablets , 1 mg and 2 mg, of Takeda Pharmaceuticals U.S.A. Inc and are indicated for the treatment of chronic idiopathic constipation (CIC) in adults, it added. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Play War Thunder now for free War Thunder Play Now Undo Citing IQVIA MAT April 2025 data, the company said Prucalopride tablets, 1 mg and 2 mg, had estimated annual sales of USD 184 million in the US.
Business Standard
26-06-2025
- Business
- Business Standard
Lupin launches Prucalopride Tablets in US market
Lupinannounced the launch of Prucalopride Tablets, 1 mg, and 2 mg, in the United States, following the recent approval of its Abbreviated New Drug Application (ANDA) from the U.S. FDA. Prucalopride Tablets are bioequivalent to Motegrity Tablets, 1 mg and 2 mg, of Takeda Pharmaceuticals U.S.A. Inc., and indicated for the treatment of chronic idiopathic constipation (CIC) in adults. Prucalopride Tablets, 1 mg, and 2 mg (RLD Motegrity) had estimated annual sales of USD 184 million in the U.S. (IQVIA MAT April 2025).
Business Standard
25-06-2025
- Business
- Business Standard
Lupin receives USFDA approval for generic Prucalopride tablets
Lupin announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its abbreviated new drug application (ANDA) for Prucalopride tablets. The tablets are a generic equivalent of Motegrity Tablets, developed by Takeda Pharmaceuticals U.S.A., Inc., and are indicated for the treatment of chronic idiopathic constipation (CIC) in adults. Lupin stated that the approved product is bioequivalent to Motegrity and will be manufactured at the companys facility in Goa, India. According to IQVIA MAT data for April 2025, Prucalopride Tablets (Reference Listed Drug: Motegrity) had estimated annual sales of approximately $184 million in the United States. Lupin is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. It specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. The companys consolidated net profit surged 114.9% to Rs 772.52 crore on a 13.6% jump in net sales to Rs 5,562.20 crore in Q4 FY25 over Q4 FY24. The scrip rose 0.07% to Rs 1,932.10 on the BSE.
Time of India
25-06-2025
- Business
- Time of India
Lupin gets USFDA nod for generic chronic constipation treatment drug
Synopsis Lupin Limited has received the United States Food and Drug Administration approval for its generic version of Prucalopride tablets. These tablets are used for treating chronic idiopathic constipation. The approved strengths are 1 mg and 2 mg. This generic medicine is bioequivalent to Takeda Pharmaceuticals' Motegrity tablets. Lupin will manufacture the product at its Goa facility in India.
