Repro Med Systems Inc. (KRMD) stock leaped by 7.84% in the after-hours while it barely kept in the green during regular trading on Tuesday. The stock surged after the news of its FREEDOM60® receiving FDA 510(k) Clearance emerged.
In the regular session, the stock gained a minuscule 0.99% at its close of $3.06 with 201.15K shares. Following the news, the stock jumped up to reach $3.30 in the after-hours’ session.
Repro Med Systems Inc. which does its business as KORU Medical Systems, has a market capitalization of $135.02 million. Currently, the company has 44.56 million shares outstanding in the market.
Moreover, KRMD stock has gained 3.03% in the past five days while losing 13.80% last month. Furthermore, the year-to0date loss of the stock stands at 49.17%.
KRMD’s FREEDOM60
FREEDOM60 infusion system is completely portable and easy to use, specifically designed for infusion of liquid medications at home.
On December 21, the company announced that its FREEDOM60 received 510(k) clearance from the FDA. According to this, the on-label use of the infusion system has expanded to two more subcutaneous lg (SClg) medications. These medications include Cutaquig® and Xembify® manufactured by Octapharma and Grifols, respectively.
According to the President and CEO of KRMD, Linda Tharby, this new clearance will allow having more options for subcutaneous immunoglobulin therapy at home. Furthermore, the company’s Freedom Infusion System has clearance for more SCIg drugs than any other system.
In addition, KRMD’s FreedomEdge® infusion pump had also recently received FDA 510(k) clearance for the use of Hizentra® prefilled syringes. Hizentra® is the most prescribed subcutaneous lg product which is also the first to be available in prefilled syringe format.
Hence, both these new 510(k) clearances support and strengthen the company’s position in the SCIg market.
Financial Analysis
On November 10, the company announced its financial results for the third quarter of 2021. In the third quarter of 2021, which ended on September 30, KRMD generated revenue of $6.0 million. This compares to $6.1 million in the year-ago quarter, with a decrease of 0.7% year over year.
Moreover, the company incurred a net loss of $1.1 million in the third quarter of 2021, against a net income of $0.2 million in Q3 of 2020. Consequently, the net loss was $0.02 per diluted share in the Q3 of 2021, against net income of $0.01 per diluted share in the Q3 of 2020.
