The Watertown, Mass.-based company posted losses of -$31.1 million, or -55¢ per share, on sales of $2.2 million for the three months ended Dec. 31, 2020, for a more than $10 million bottom-line slide on sales growth of 89.7%.
Kala Pharmaceuticals’ EPS of -55¢ came in 9¢ behind Wall Street, where analysts were looking for sales of $2.4 million.
The company’s major highlight for the quarter was the FDA approval of its Eysuvis therapy. The Eysuvis loteprednol etabonate ophthalmic suspension uses the company’s Ampplify mucus-penetrating particle (MPP) drug delivery technology to enhance the penetration of loteprednol etabonate (LE) into target tissue on the ocular surface in treating signs and symptoms of dry eye disease.
“2020 was a pivotal year for Kala, highlighted by [FDA] approval of Eysuvis, the first and only prescription therapy specifically for the short-term treatment of dry eye disease and our second product approval in as many years. Now, with launch activities underway, we are seeing prescription growth and pleased to have secured formulary access with Express Scripts as we continue to broaden our managed care coverage,” Kala chairman, president & CEO Mark Iwicki said in a news release. “As we begin the new year, we are operating from a position of strength. We believe we are well-funded, with sufficient resources to support our commercial efforts and investments in our pipeline, which includes several preclinical programs with the potential to address multiple front and back of the eye diseases.”
Kala did not offer financial guidance for fiscal year 2021.
KALA shares were down -3.1% at $8.65 per share in early-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was virtually unchanged.