Ultimi earnings 13 /marzo /2019:
“As part of our compliance enhancement upgrades to our Boca Raton, FL facility, we optimized the intravenous immunoglobulin (“IVIG”) manufacturing process for BIVIGAM®. We continue to work with the FDA to finalize our BIVIGAM Prior Approval Supplement (“PAS”) for drug substance, with the goal of reintroducing BIVIGAM® to the market this year. We are also working closely with the FDA on the pending application for RI-002’s initial approval, and the FDA action date is scheduled for April 2, 2019,” continued Mr. Grossman.
“Other notable accomplishments include: retiring approximately 8.6 million shares of our non-voting common stock from Biotest Pharmaceuticals Corporation, receiving FDA approval of our plasma collection center in Kennesaw, GA, obtaining FDA approval for the BIVIGAM® drug product PAS and completing a debt refinancing of up to $72.5 million with Perceptive Advisors.”
Mr. Grossman concluded, “We look forward to continuing to work with the FDA during 2019 as we seek FDA approval for the pending applications for both RI-002 and BIVIGAM®. FDA approval for RI-002 and BIVIGAM®, if received, along with Nabi-HB®, our presently commercially available hyperimmune globulin, would give us three commercial immune globulin products and would make ADMA one of the few globally recognized plasma manufacturers offering a portfolio of novel immune globulin products.”
Recent Achievements and Upcoming Milestones
Improved compliance status for the Boca Raton, FL facility to VAI, enabling ADMA to submit regulatory applications for FDA review and potential approval
Obtained FDA approval for our Kennesaw, GA plasma collection center
Completed a debt refinancing of up to $72.5 million with Perceptive Advisors
Ongoing work with the FDA to obtain approval of the BIVIGAM® drug substance PAS in order to relaunch the product
Prescription Drug User Fee Act action date of April 2, 2019 for RI-002
Potential commercial sales of BIVIGAM® and RI-002
Continue to produce, release and market commercial product for Nabi-HB® in the U.S.
Expand promotional activities for Nabi-HB
Financial Results for the Year Ended December 31, 2018
ADMA reported total revenues of $17.0 million for the year ended December 31, 2018, as compared to $22.8 million for the year ended December 31, 2017, representing a decrease of $5.8 million. The decrease in revenues is primarily due to $7.0 million of non-recurring revenue generated in 2017 that was related to an amendment to our contract manufacturing agreement and a decrease in the sale of normal source plasma of $1.6 million in 2018 due to increased competition from other plasma donation centers which have opened in close proximity to the plasma collection centers we transferred to Biotest on January 1, 2019, partially offset by an increase in Nabi-HB revenues of $2.8 million.
The consolidated net loss for the year ended December 31, 2018 was $65.7 million, or $(1.45) per basic and diluted share, as compared to a consolidated net loss of $43.8 million, or $(1.91) per basic and diluted share for the year ended December 31, 2017. The increase in net loss of $22.0 million was primarily attributable to an increase in cost of product revenue from the manufacture of conformance lots production of RI-002 and BIVIGAM®, which can be used for commercial sales upon FDA approval, higher operational expenses reflecting a full year of operations at the Boca Raton, FL facility for 2018, as compared to just seven months of operating activity at the Boca Raton, FL facility in 2017, as well as the initiation of marketing and commercial activities and the decrease in revenues. Included in the net loss for the year ended December 31, 2018 were non-cash expenses of $6.8 million for stock-based compensation, depreciation and amortization, and non-cash interest expense.
At December 31, 2018, ADMA had cash and cash equivalents of $22.8 million, as compared to $43.1 million at December 31, 2017. ADMA’s net working capital was $34.9 million as of December 31, 2018, as compared to $52.9 million as of December 31, 2017.