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Last $9.32 USD
Change Today +0.34 / 3.79%
Volume 15.5K
ADMA On Other Exchanges
As of 8:10 PM 07/31/15 All times are local (Market data is delayed by at least 15 minutes).

adma biologics inc (ADMA) Snapshot

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12/3/14 - $14.00
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adma biologics inc (ADMA) Details

ADMA Biologics, Inc., a late stage biopharmaceutical company, develops, manufactures, and intends to market plasma-based biologics for the treatment and prevention of certain infectious diseases. Its lead product candidate is RI-002, which is in Phase III clinical trial intended for the treatment of primary immune deficiency disease. RI-002 is an injectable immune globulin derived from human plasma enriched with high levels of naturally occurring polyclonal antibodies, as well as high levels of antibodies targeted to respiratory syncytial virus. The company also operates ADMA BioCenters, which are plasma collection centers. ADMA Biologics, Inc. was founded in 2004 and is headquartered in Ramsey, New Jersey.

60 Employees
Last Reported Date: 03/9/15
Founded in 2004

adma biologics inc (ADMA) Top Compensated Officers

Founder, Chief Executive Officer, President a...
Total Annual Compensation: $572.6K
Chief Financial Officer and Vice President
Total Annual Compensation: $398.1K
Chief Scientific & Medical Officer and Execut...
Total Annual Compensation: $377.0K
Compensation as of Fiscal Year 2014.

adma biologics inc (ADMA) Key Developments

ADMA Biologics, Inc. Announces Submission of RI-002 Biologics License Application to FDA

ADMA Biologics, Inc. announced that it has submitted its Biologics License Application (BLA) to the United States Food and Drug Administration (FDA), seeking marketing authorization for RI-002. RI-002 demonstrated positive results in a Phase III study in patients with PI, meeting its primary endpoint of no serious bacterial infections (SBI). These results, included in the submission, more than meet the requirement specified by the FDA guidance of = 1 SBI per patient-year. The FDA has a 60-day review period to determine whether ADMA's BLA submission for RI-002 is complete and acceptable for filing.

ADMA Biologics, Inc. Announces Executive Appointments

ADMA Biologics, Inc. announced recent multiple senior appointments to the company's commercial team as part of company's ongoing commercialization activities, in preparation for its planned Biologics License Application (BLA) filing with the U.S. Food and Drug Administration (FDA) for RI-002. James Hauert, has been appointed Senior Vice President, Commercialization & Strategy. Mr. Hauert is responsible for building a commercialization infrastructure to ensure market utilization and adoption of company's product candidates, as well as revenue generation and growth for the overall organization. Mr. Hauert has over 25 years of U.S. and global marketing and sales experience, including a previous role with Baxter Healthcare Corporation, where he served as Vice President Marketing & Strategy, North America, BioScience Division. Mr. Hauert has led numerous product launches, developing core messaging for branding campaigns and in revitalizing products throughout the life cycle. Doris Connell, Pharm.D. has been appointed Vice President, Medical Affairs. Dr. Connell is responsible for developing the company's medical information, medical education scientific plan and strategy with senior management in efforts to support the company's product candidates. Dr. Connell is also responsible for developing, organizing, staffing and training the Medical Science Liaison (MSL) and Medical Information teams. Dr. Connell brings over 20 years of medical affairs experience in a variety of therapeutic indications. Most recently, Dr. Connell served as the Therapeutic Area Director at GlaxoSmithKline where she managed MSL Directors and teams across several therapy areas and led commercialization and launch efforts. Prior to GlaxoSmithKline, Dr. Connell was with Human Genome Sciences as a Director, Medical Science Liaisons (Immunology) responsible for supporting new product launch and leading the national MSL team. Prior to Human Genome Sciences, Dr. Connell was with Daiichi Sankyo as a Regional Director, Field Medical Affairs where she managed MSLs through product launches, supported marketing initiatives and lead MSL payer and market access initiatives. Theresa Gwaltney has been appointed Senior Director, Supply Chain Operations. Ms. Gwaltney is responsible to ensure the company is able to manufacture, process, package, fill and distribute company's investigational, clinical and commercial drug products, specifically RI-002. Ms. Gwaltney will work with the senior management team and company's contract vendors to coordinate the logistical supply chain for RI-002. Ms. Gwaltney brings over 25 years of management experience in materials management operations, contract manufacturing, purchasing, inventory control, warehousing and distribution, along with oversight of all logistic operations and material and supplier management. Most recently, Ms. Gwaltney served as the Director, Supply Chain Operations at Shire, (previously ViroPharma Biologics and Lev Pharma). Prior to Lev Pharma, Ms. Gwaltney was Quality Team Leader at Eli Lily, and Associate Director, Materials Management at MedImmune.

ADMA Biologics, Inc., ADMA Plasma Biologics, Inc. and ADMA Bio Centers Georgia Inc. Enter into Loan and Security Agreement with Oxford Finance LLC

On June 19, 2015, ADMA Biologics, Inc., ADMA Plasma Biologics, Inc. and ADMA Bio Centers Georgia Inc. entered into a Loan and Security Agreement (the Loan Agreement), with Oxford Finance LLC, as collateral agent and lender (Oxford") and the other lenders party thereto from time to time (together with Oxford, the Lenders"), pursuant to which Oxford agreed to make term loans to the Company in an aggregate principal amount of $21.0 million, subject to the terms and conditions set forth in the Loan Agreement. In connection with securing the Loan Facility, the Company prepaid all outstanding amounts under its Loan and Security Agreement, dated December 21, 2012, with Hercules Technology Growth Capital, Inc., as amended from time to time. The Company drew down the initial term loan in the aggregate principal amount of $16.0 million (the Term A Loan") on June 19, 2015. The Term A Loan accrues interest at a rate equal to the greater of 7.80% or the sum of the three-month LIBOR rate plus 7.54% per annum (the Term Loan Interest Rate). The Company is required to make interest-only payments for the period ending January 31, 2017, and starting on February 1, 2017 (the Amortization Commencement Date"), the Company is required to make payments of principal and accrued interest in equal monthly installments sufficient to amortize the Term A Loan over the next thirty-six months, through January 1, 2020 (the Maturity Date; and such repayment period, the Amortization Period). However, if the Company obtains approval from the U.S. Food and Drug Administration of the Biologics License Application (the BLA Approval") for the Company's product candidate, currently referred to as RI-002, on or before January 31, 2017, the Amortization Commencement Date will be deferred to August 1, 2017, and, within thirty days after BLA Approval, the Company may draw down an additional term loan (the Term B Loan" and, together with the Term A Loan, the Term Loans") in the aggregate principal amount up to $5.0 million. The Term Loans will accrue interest at the Term Loan Interest Rate. If the Company elects to use the additional six months of interest-only payments following receipt of BLA Approval for RI-002, the Amortization Period for the aggregate principal amount of the Term Loans will be shortened to thirty months, ending on the Maturity Date. The Company is obligated to pay lender fees and expenses, including facility fees and expenses, in the aggregate amount of approximately $135,000. At maturity of the Term Loans, or earlier repayment in full following voluntary prepayment or upon acceleration, the Company is required to make additional payments in an aggregate amount equal to 8.95% of the funded amount of the Term Loans if the Company does not extend the original interest-only period, and in an aggregate amount of 9.95% of the funded amount of the Term Loans if the interest-only period is extended from eighteen months to twenty-four months. The Loan Agreement contains customary representations and warranties and customary affirmative and negative covenants, including, among others, limits or restrictions on the Company's ability to incur liens, incur indebtedness, make certain restricted payments, merge or consolidate and dispose of assets. In addition, it contains customary events of default that entitle Oxford to cause any or all of the Company's indebtedness under the Loan Agreement to become immediately due and payable.


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