ADMA Biologics Provides Corporate Update

11/5/17

RAMSEY, N.J., Nov. 03, 2017 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA), a vertically integrated commercial biopharmaceutical and specialty immunoglobulin company that develops, manufactures and markets specialty plasma-based biologics for the treatment of Primary Immune Deficiency Disease (“PIDD”) and the prevention and treatment of certain infectious immunological diseases, today provided a corporate update, including recent progress with its manufacturing and quality systems, and announced its financial results for the fiscal quarter ended September 30, 2017.

“Since completing the acquisition of certain assets of Biotest Pharmaceuticals Corporation’s Therapy Business Unit (“BTBU”), we are pleased to report we continue to make progress with business integration, improving operating efficiencies, and remedying our outstanding U.S. Food and Drug Administration (“FDA”) compliance issues,” said Adam Grossman, President and Chief Executive Officer of ADMA.

Mr. Grossman continued, “Importantly, we remain on schedule to be FDA inspection-ready by year-end 2017. We have continued commercial production for Nabi-HB®, an FDA-approved hyperimmune globulin for the treatment of Hepatitis B during the third quarter of 2017 and further advanced our optimization program for our immunoglobulin manufacturing process, which is the process used for both Bivigam®, an FDA-approved immune globulin intravenous (“IGIV”) for the treatment of primary humoral immunodeficiency and RI-002 our lead IGIV product candidate intended for immunodeficient patients. We are pleased with our operational progress, as we achieved year-over-year revenue growth of approximately 61 percent in the third quarter ,” concluded Mr. Grossman.

2017 YTD Achievements and Anticipated Goals

  • Completed the acquisition of the BTBU, creating a U.S.-domiciled, vertically-integrated commercial drug manufacturer and provider of specialty- plasma biotherapeutics
  • Generated accretive revenues from FDA-approved BTBU-acquired assets
  • Continued the successful integration of BTBU operations into ADMA
  • Established a timeline and engaged Subject Matter Experts to assist with the remediation of the FDA warning letter and compliance issues for the acquired Boca Raton, FL manufacturing facility (the “Boca Facility”)
  • Resumed commercial product manufacturing at the Boca Facility
  • On track to be FDA “Inspection-Ready” by year-end 2017
  • Initiated the buildout of our third ADMA BioCenter plasma collection facility
  • Secured a second patent for immunotherapeutics methods for RI-002


Financial Results for the Three Months Ended September 30, 2017

ADMA reported total revenues of $4.7 million for the third quarter ended September 30, 2017, as compared to $2.9 million for the third quarter ended September 30, 2016, representing an increase of approximately 61%. This growth was primarily attributable to sales of Nabi-HB® as a result of the acquisition of certain BTBU assets, which included the commercial rights to Nabi-HB®.

The consolidated net loss for the quarter ended September 30, 2017 was $15.2 million, or $0.59 per basic and diluted share, as compared to a consolidated net loss of $4.3 million, or $0.34 per basic and diluted share, for the quarter ended September 30, 2016. The increase in net loss of $10.9 million was primarily attributable to increased product revenue costs of $9.6 million, which included manufacturing costs related to the Boca Facility, including third-party consultant fees of approximately $2.0 million pertaining to the remediation efforts in response to the FDA warning letter. Additionally, the Company incurred increased selling, general and administrative expenses of $2.4 million, which were primarily related to costs associated with the Boca Facility. These costs were partially offset by increased revenues of $1.8 million. Included in the net loss for the third quarter ended September 30, 2017 were non-cash expenses of $1.9 million for stock-based compensation, non-cash interest expense and depreciation and amortization.

Financial Results for the Nine Months Ended September 30, 2017

ADMA reported total revenues of $10.8 million for the nine months ended September 30, 2017, as compared to $7.3 million for the nine months ended September 30, 2016, representing a period-over-period increase of approximately 47%, which was driven by the sales of Nabi-HB® and increased plasma collection revenues.

The consolidated net loss for the nine months ended September 30, 2017 was $30.8 million, or $1.67 per basic and diluted share, as compared to a consolidated net loss of $15.0 million, or $1.26 per basic and diluted share, for the nine months ended September 30, 2016. The increase in net loss of $15.8 million was primarily attributable to increased product revenue costs of $12.9 million, which include manufacturing costs related to the Boca Facility, including third-party consultant fees of approximately $2.5 million pertaining to the remediation efforts in response to the FDA warning letter, as well as increased selling, general and administrative expenses of $7.7 million, which include transaction costs for the acquisition of the BTBU of $3.9 million. These costs were partially offset by increased revenues of $3.5 million for the quarter ended September 30, 2017. Included in the net loss for the nine months ended September 30, 2017 were non-cash expenses of $2.8 million for stock-based compensation, depreciation and amortization and non-cash interest expense.

At September 30, 2017, ADMA had cash, cash equivalents and short-term investments of $13.6 million, as compared to $15.3 million at December 31, 2016. ADMA’s net working capital as of September 30, 2017 was $18.1 million, as compared to $10.4 million as of December 31, 2016.

About ADMA Biologics, Inc. (ADMA)

ADMA is a vertically integrated commercial biopharmaceutical and specialty immunoglobulin company that develops, manufactures and markets specialty plasma-based biologics for the treatment of Primary Immune Deficiency Disease (“PIDD”) and the prevention and treatment of certain infectious immunological diseases. ADMA's mission is to develop and commercialize plasma-derived, human immune globulins targeted to niche patient populations for the treatment and prevention of certain infectious immunological diseases. The target patient populations include immune-compromised individuals who suffer from an underlying immune deficiency disease, or who may be immune-compromised for medical reasons. ADMA has received U.S. Patents 9,107,906 and 9,714,283 related to certain aspects of its product candidate, RI-002. For more information, please visit www.admabiologics.com.

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