ADMA Biologics Inc (NASDAQ:ADMA) has announced the submission of complete response letter for BIVIGAM to US FDA on December 19, 2018. BIVIGAM comprises 10% IVIG and Intravenous Immune Globulin. FDA would issue an acknowledgment receipt in 30 days to ADMA. The company would release an update on the progress of BIVIGAM PAS (Prior Approval Supplement). The stock has gained 20.83% in the last trading session on a volume of 4.0 Million shares.
The share prices of ADMA has surged by 7% on submitting the complete response letter to the US FDA. The market for immuno globulin in the US is strong. ADMA targets RI-002 to treat primary immune deficiency disease in April 2019.
ADMA secures a loan of $72.5 million from Perceptive Advisors
ADMA has secured a loan of $72.5 million from Perceptive Advisors. The company receives funding in two tranches. The company uses the first tranche of $40 million to close the former senior credit of $30 million. It uses the second tranche of $27.5 million for the approval of RI-002 Biologics Logics License Application or BIVIGAM PAS. The loan duration matures in March 2022. The loan facility is free from back-end fee.
Chief Executive Officer and President of ADMA, Adam Grossman said the company received the funding at the right time when it is seeking approval for immunoglobulin products RI-002 and BIVIGAM. Perceptive is an equity shareholder in ADMA, with a complete understanding of the business of ADMA. Perceptive loan facility shows the confidence in ADMA business. The approval of products by the FDA and access to funding help the company to focus on production activities. The company will use the funds for the construction of plasma collection centers. It will also prepare to commercialize RI-002 and BIVIGAM.
Funding of Perceptive promotes a growth strategy
Portfolio Manager of Perceptive, Sam Chawla said the company is pleased with the vision of ADMA to develop immunoglobulin therapeutics. It is providing the funding to promote development efforts, product launches and support growth strategy.
After taking over Boca Raton FL production facility in the year 2017, ADMA made considerable progress in receiving intellectual property and compliance status of the facility. Sam said the company would continue to fund to drive the growth forward. Perceptive fixed an annual interest rate of 7.5% for the loan.