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Wednesday, May 3, 2023

Amarin Reports Stable Revenue, Cash Position In Q1, Lowers FY23 Operating Expense Guidance

 

  • Amarin Corporation plc  reported first-quarter sales of $85.97 million, a decrease of 9.2% Y/Y and beating the consensus of $81.23 million, due to a decline in volume and net selling price due to the impact of generic competition in the U.S.

  • Amarin continues actively monitoring key performance indicators in the U.S. market to support its strategy thoughtfully.

  • Amarin's gross margin on net product revenue was 55%, down from 76% a year ago. The company amended a supplier agreement resulting in a charge of $12.3 million. Excluding the impact of this item, the gross margin was 70%. The remaining decrease in gross margin is primarily a result of a decrease in net selling price.

  • Amarin posted an adjusted EPS loss of $0.02, a shift from a loss of $(0.06) a year ago and beating the consensus of $(0.03).

  • "We continue to make progress on our financial initiatives and our pursuit of operational excellence beyond our initial $100 million cost savings target," said CFO Tom Reilly. 

  • "We have been working to renegotiate our supply agreements, including the most recent settlement this quarter. With these efforts, we reduced operating expense guidance for 2023," Reilly added.

  • Amarin lowered its FY23 operating expense guidance to $270 million-$285 million from $290 million-$305 million.

  • The company reiterates that current cash and investments and other assets are adequate to support continued operations, including European launch activities.

Why EyePoint Pharmaceuticals Shares Are Shooting Higher

 EyePoint Pharmaceuticals Inc 

 reported Q1 revenues of $7.68 million, down from $9.3 million a year ago but slightly beating the $7.43 million consensus.

Operating expenses reached $29.2 million compared with $27.6 million a year ago, primarily driven by continued investment in R&D for EYP-1901 development, offset by a reduction in sales and marketing spend for DEXYCU.

Net product revenue for Yutiq was $7.4 million, up 60% Y/Y, with a customer demand of approximately 930 units.

The company reported a smaller-than-expected EPS loss of $(0.56), beating the consensus of $(0.68).

Cash, cash equivalents, and investments of $122.5 million will provide a cash runway into the second half of 2024.

Pipeline Update:

  • The company completed enrollment in an oversubscribed Phase 2 DAVIO 2 trial of EYP-1901 for maintenance treatment for wet AMD in March 2023. Topline data remain on track for Q4 of 2023.
  • Enrollment ahead of schedule in the Phase 2 PAVIA trial of EYP-1901 in non-proliferative diabetic retinopathy. The trial size was reduced based on robust clinical evidence and proof-of-concept for vorolanib and EYP-1901.
  • Plans to initiate a Phase 2 trial evaluating EYP-1901 in diabetic macular edema in Q1 of 2024 remain on track.

What's Going On With Kiromic BioPharma

 Kiromic BioPharma Inc 

 shares are gaining Wednesday morning. However, there is no specific news today. During the session, the share price reached $9.22.

Monday morning, the FDA authorized the company's Investigational New Drug (IND) application to initiate a Phase 1 trial to evaluate Deltacel (KB-GDT-01) for patients with non-small cell lung cancer (NSCLC).

The company expects to start the trial in Q2 of 2023.

Deltacel is the company's allogeneic, non-engineered, off-the-shelf Gamma Delta T-cell therapy.

The company submitted the IND application in early April.

Kiromic BioPharma stock is gaining on heavy volume, with a session volume of 3.6 million shares traded, compared to the trailing 100-day volume of 164.038K shares.

https://www.benzinga.com/general/biotech/23/05/32190317/whats-going-on-with-kiromic-biopharma-stock-wednesday