ADMA Biologics Upcoming PDUFA Dates and Milestones

ADMA Biologics, Inc. (NASDAQ: ADMA) is a vertically integrated commercial biopharmaceutical company that manufactures, markets and develops specialty plasma-based biologics for the treatment of Primary Immune Deficiency Disease (“PIDD”) and the prevention and treatment of certain infectious diseases.


On Nov. 08, 2018, the company announced its financial results for the quarter and nine months ended September 30, 2018 and provided an update on its operations and upcoming milestones.


Recent Achievements and Upcoming Milestones

  • PDUFA target action date of December 18, 2018, for BIVIGAM®
  • PDUFA target action date of April 2, 2019, for RI-002
  • Boca facility compliance status improved to Voluntary Action Indicated
  • Obtained FDA approval for the 3rd plasma collection center
  • Increased revenues by approximately 20% for the nine months ended September 30, 2018, as compared to the same period in 2017
  • Continue to produce, release and market commercial product for Nabi-HB® in the U.S.
  • Expand promotional activities for Nabi-HB®



The company is rapidly progressing towards full-fledged commercialization stage with significant upside potential. ADMA has made substantial progress executing on its key initiatives throughout 2018. Most importantly, it improved the U.S. Food and Drug Administration (“FDA”) compliance status for its manufacturing facility in Boca Raton, Florida, which allowed it to submit applications for approval for the relaunch of BIVIGAM® and the approval and launch of RI-002.


The company also obtained FDA approval for its third plasma collection center, which was announced during the third quarter and occurred ahead of expectations. The management is looking forward to the coming months as it continues working with the FDA and commercializes its intravenous immune globulin products, which are expected to grow the top line in 2019.


Near-Term Milestone:

The company has two upcoming Prescription Drug User Fee Act (“PDUFA”) dates for these products: BIVIGAM® on December 18, 2018, and RI-002 on April 2, 2019.


Analyst ratings and target price:

Per, Their average twelve-month price target is $11.5833, suggesting that the stock has a possible upside of 155.70%. The high price target for ADMA is $17.00, and the low-price target for ADMA is $7.50. There are currently six buy ratings for the stock, resulting in a consensus rating of “Buy.”


Below are the excerpts of recent analyst rating/Price targets on the company:

Description & about the Company:

ADMA’s mission is to develop and commercialize plasma-derived, human immune globulins targeted to niche patient populations, including immune-compromised individuals who suffer from an underlying immune deficiency disease or who may be immune-compromised for other medical reasons. ADMA has received U.S. Patents 9,107,906, 9,714,283, 9,815,886 and 9,969,793 related to certain aspects of its lead product candidate, RI-002.


Products, Pipeline, and ongoing R&D:

Market potential:

Q-3 Financial Results:

Revenue: ADMA reported total revenues of $4.2 million for the quarter ended September 30, 2018, as compared to $4.7 million for the quarter ended September 30, 2017, representing a decrease of $0.5 million.  The decrease in revenues was primarily due to the timing of shipments of normal source plasma to certain customers in accordance with their agreements from the ADMA Bio Centers plasma collection business segment, partially offset by an increase in revenues from commercial product produced at the plasma manufacturing facility (the “Boca Facility”).

Profitability: The consolidated net loss for the quarter ended September 30, 2018, was $15.1 million, or $(0.33) per basic and diluted share, as compared to a consolidated net loss of $15.2 million, or $(0.59) per basic and diluted share, for the quarter ended September 30, 2017. The net loss in 2018 includes approximately $7.0 million in unabsorbed manufacturing costs at the Boca Facility and non-cash expenses of $1.7 million for stock-based compensation, depreciation and amortization, and non-cash interest expense.

Liquidity and financial flexibility: At September 30, 2018, ADMA had cash and cash equivalents of $42.4 million, as compared to $43.1 million at December 31, 2017. ADMA’s net working capital as of September 30, 2018, was $52.6 million, as compared to $53.7 million as of December 31, 2017. In the second quarter of 2018, the Company completed an underwritten public offering of its common stock and received net proceeds of $42.9 million.


Key Stock Influences:

Successful completion of the upcoming milestones would lead future direction for the company. Any adversities related to these upcoming milestones might adversely impact the overall investor sentiments.


ADMA is still an early stage entity and has not yet generated meaningful revenue and will likely operate at a loss as it grows its market position and seeks ways to monetize it.


ADMA has a history of operating losses. Therefore, any time or cost overrun in its ongoing R&D activities and its impact on business & financial profile will remain a key business sensitivity factor.


Stock Chart:

On Friday, December 14th, 2018, ADMA closed at $4.53 on an above volume of 148,663 shares exchanging hands. Market capitalization is $209.971 million. The current RSI is 35.18


In the past 52 weeks, shares of ADMA have traded as low as $2.49 and as high as $6.96


At $4.53, shares of ADMA are trading below its 50-day moving average (MA) at $5.30 and below its 200-day MA at $5.28


The present support and resistance levels for the stock are at $4.18 & $5.16 respectively.



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