Quarterly report pursuant to Section 13 or 15(d)

14. SUBSEQUENT EVENTS

v3.19.1
14. SUBSEQUENT EVENTS
3 Months Ended
Mar. 31, 2019
Subsequent Events [Abstract]  
14. SUBSEQUENT EVENTS

BLA Approval

On April 1, 2019, the FDA approved ASCENIV, Immune Globulin Intravenous, Human – slra 10% Liquid, formerly referred to as RI-002. ASCENIV is an IVIG drug product for the treatment of PI in adults and adolescents (12 to 17 years of age). The Company anticipates having the product available for commercial launch during the second half of 2019.

 

Credit Facility

On May 3, 2019, in connection with the FDA’s approval of ASCENIV, the Company accessed the additional $27.5 million available under the Perceptive Credit Facility through the issuance of a promissory note evidencing the Perceptive Tranche II Loan (see Note 6). The Company intends to use the proceeds from the Perceptive Tranche II Loan (i) to support the commercial launch of ASCENIV anticipated during the second half of 2019, (ii) to expand the Company’s plasma collection facility network; and (iii) for working capital and general corporate purposes, including the procurement of raw material inventory.

 

Also on May 3, 2019, the Company and Perceptive entered into an amendment to the Perceptive Credit Agreement (the “Perceptive Amendment”) whereby Perceptive agreed to an additional commitment under the Perceptive Credit Facility in the principal amount of up to $12.5 million (the “Perceptive Tranche III Loan”) to be drawn-down at the Company’s sole option. The Perceptive Tranche III Loan is subject to the satisfaction of certain conditions, including, but not limited to, FDA approval of the BIVIGAM PAS and no Material Adverse Changes (as defined in the Perceptive Credit Agreement) having occurred since December 31, 2018; provided that the Perceptive Tranche III Loan would not be made later than March 31, 2020. The Perceptive Tranche III Loan will have terms that are substantially identical to those of the Initial Perceptive Loans. The Perceptive Tranche III Loan required the Company to pay a facility fee to Perceptive in the amount equal to 1% of the maximum amount of the Perceptive Tranche III Loan on May 3, 2019. In addition, the Company issued a warrant (the “Perceptive Tranche III Warrant”) to purchase 250,000 shares of the Company’s common stock to Perceptive with an exercise price equal to $4.64 per share, which represents the trailing 10-day volume weighted average price of the Company’s common stock as of May 2, 2019.