ADMA Biologics Reports Record Second Quarter 2021 Financial Results and Highlights Recent Progress and Accomplishments

 

Achieved Record Total Revenues of $17.8 Million in Second Quarter 2021, a 129% Increase Over Second Quarter 2020

 

Narrowed Gross and Net Losses Year-over-Year

 

ADMA Now Anticipates Exiting 2021 Approaching an Annualized Revenue Run Rate of Approximately $100 Million or More; Reiterates All Previously Communicated Strategic and Financial Objectives

 

Management to Host Conference Call and Webcast Today at 4:30 p.m. ET

 

 

“ADMA has also seen a substantial strengthening of its supply chain in the first half of the year.  The recent receipt of zero Form 483 observations as a part of the pre-approval inspection (“PAI”) for the VanRx machine paves the way for an anticipated approval over the coming months. When approved, it will cap a multi-year remediation and end-to-end supply chain initiative at the Boca Raton, FL manufacturing facility, and will propel ADMA into an elite group of U.S.-based drug manufacturers with comprehensive in-house control of a majority of its critical manufacturing functions.

“Over the past 4 years, ADMA has also been diligently building a vertically integrated commercial biologics manufacturing organization since acquiring its manufacturing facility and assets in June 2017 and is now successfully emerging from its multi-year investment, regulatory and remediation phase.  The majority of substantive investments are now in the rearview, the wholly owned manufacturing plant is now fully remediated and collectively, positions the Company to meet or exceed all longer-term financial targets. These accomplishments could not have been realized without the dedication and focus of ADMA’s staff, leadership and advisors. We commend the entire team for their extraordinary efforts focused on improving healthcare for U.S. patients,” concluded Mr. Grossman.

Select Second Quarter 2021 Achievements & Recent Corporate Developments:

Second Quarter 2021 Financial Results

 

Total revenues for the quarter ended June 30, 2021, were approximately $17.8 million, compared to approximately $7.8 million for the quarter ended June 30, 2020, representing an increase of approximately $10.0 million, or 129%.  The revenue growth for the quarter ended June 30, 2021, compared to the quarter ended June 30, 2020, was favorably impacted by the continued commercial ramp-up of ADMA’s IVIG product portfolio.

 

Consolidated net loss for the quarter ended June 30, 2021 was approximately $18.9 million, or $(0.15) per basic and diluted share, compared to a consolidated net loss of approximately $20.2 million, or $(0.23) per basic and diluted share, for the quarter ended June 30, 2020.  The $1.3 million narrowing in net loss compared to the prior year period was primarily attributable to increased revenues and improved gross margins.  The net loss incurred during the second quarter of 2021 includes a one-time, non-recurring charge related to a separation and transition agreement in the amount of approximately $0.8 million.

 

At June 30, 2021, ADMA had cash and cash equivalents of approximately $42.4 million and accounts receivable of approximately $23.5 million, compared to cash and cash equivalents of approximately $75.8 million and accounts receivable of approximately $6.5 million as of June 30, 2020. ADMA’s net working capital as of June 30, 2021 was approximately $153.2 million, compared to approximately $130.1 million as of June 30, 2020.

 

Conference Call Information

 

ADMA will host a conference call today, August 11, 2021, at 4:30 p.m. Eastern Time, to discuss the fiscal second quarter 2021 financial results and recent corporate updates.  To access the conference call, please dial (855) 884-8773 (local) or (615) 622-8043 (international) at least 10 minutes prior to the start time and refer to conference ID 8992329.  A live audio webcast of the call will be available under "Events & Webcasts" in the Investor section of the Company's website, https://ir.admabiologics.com/events-webcasts.  An archived webcast will be available on the Company's website approximately two hours after the event.

 

About BIVIGAM^®

 

BIVIGAM^® (immune globulin intravenous, human – 10% liquid) is a plasma-derived, polyclonal, intravenous immune globulin (IVIG).  BIVIGAM^® was approved by the FDA in May 2019 and is indicated for the treatment of primary humoral immunodeficiency (PI), including, but not limited to the following group of genetic disorders: X-linked and congenital agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome and severe combined immunodeficiency.  BIVIGAM^® contains a broad range of antibodies similar to those found in normal human plasma.  These antibodies are directed against bacteria and viruses and help to protect PI patients against serious infections.  BIVIGAM^® is a purified, sterile, ready-to-use preparation of concentrated human Immunoglobulin antibodies.  Certain data and other information about BIVIGAM^® or ADMA and its products can be found on the Company’s website at www.admabiologics.com.

 

About Nabi-HB^®

 

Nabi-HB^® is a hyperimmune globulin that is rich in antibodies to the Hepatitis B virus. Nabi-HB^® is a purified human polyclonal antibody product collected from plasma donors who have been previously vaccinated with a Hepatitis B vaccine. Nabi-HB^® is indicated for the treatment of acute exposure to blood containing Hepatitis B surface antigen (HBsAg), prenatal exposure to infants born to HBsAg-positive mothers, sexual exposure to HBsAg-positive persons and household exposure to persons with acute Hepatitis B virus infection. Hepatitis B is a potentially life-threatening liver infection caused by the Hepatitis B virus. It is a major global health problem and can cause chronic infection and put people at high risk of death from cirrhosis and liver cancer. Nabi-HB^® has a well-documented record of long-term safety and effectiveness since its initial market introduction. Certain data and other information about Nabi-HB^® or ADMA and its products can be found on the Company’s website at www.admabiologics.com.

 

About ADMA BioCenters

 

ADMA BioCenters operates FDA-licensed facilities specializing in the collection of human plasma used to make special medications for the treatment and prevention of diseases. Managed by a team of experts who have decades of experience in the specialized field of plasma collection, ADMA BioCenters provides a safe, professional and pleasant donation environment. ADMA BioCenters strictly follows FDA regulations and guidance and enforces current good manufacturing practices (cGMP) in all of its facilities. For more information about ADMA BioCenters, please visit www.admabiocenters.com.

 

About ADMA Biologics, Inc. (ADMA)

 

ADMA is an end-to-end American commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases. ADMA currently manufactures and markets three FDA-approved plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases: BIVIGAM^® (immune globulin intravenous, human) for the treatment of primary humoral immunodeficiency (PI); ASCENIV™ (immune globulin intravenous, human – slra 10% liquid) for the treatment of PI; and NABI-HB^® (hepatitis B immune globulin, human) to provide enhanced immunity against the Hepatitis B virus. ADMA manufactures its immune globulin products at its FDA-licensed plasma fractionation and purification facility located in Boca Raton, Florida. Through its ADMA BioCenters subsidiary, ADMA also operates as an FDA-approved source plasma collector in the U.S., which provides a portion of its blood plasma for the manufacture of its products. ADMA’s mission is to manufacture, market and develop specialty plasma-derived, human immune globulins targeted to niche patient populations for the treatment and prevention of certain infectious diseases and management of immune compromised patient populations who suffer from an underlying immune deficiency, 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, 9,969,793 and 10,259,865 related to certain aspects of its products and product candidates. For more information, please visit www.admabiologics.com.

Cautionary Note Regarding Forward-Looking Statements

 

This press release contains “forward-looking statements” pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 about ADMA Biologics, Inc. and its subsidiaries (collectively, “we,” “our” or the “Company”). Forward-looking statements include, without limitation, any statement that may predict, forecast, indicate, or imply future results, performance or achievements, and may contain such words as “estimate,” “project,” “intend,” “forecast,” “target,” “anticipate,” “plan,” “planning,” “expect,” “believe,” “will,” “should,” “could,” “would,” “may,” or, in each case, their negative, or words or expressions of similar meaning. These forward-looking statements also include, but are not limited to, statements about ADMA’s future results of operations, including our anticipated timing for reaching profitability and our expected revenue run rates, meaningful gross margin improvement and operating efficiencies; the impact of COVID-19 on the Company’s financial results and business operations; expected benefits from the VanRx aseptic fill-finish machine, including cost efficiencies and contract manufacturing opportunities; the anticipated benefits from the recent implementation of Haemonetics’ Persona^® technology combined with our plasma collection network; BIVIGAM^®’s production capacity; the goal of building and opening new plasma collection centers by 2024; the Company’s plasma collections and production; our ability to maintain plasma supply; the outcome and timing of our BLA application for our new plasma centers and for FDA approval of our VanRx aseptic fill-finish machine; and the expected benefits of additional NABI-HB^® and BIVIGAM^® vial sizes. Actual events or results may differ materially from those described in this press release due to a number of important factors. Current and prospective security holders are cautioned that there also can be no assurance that the forward-looking statements included in this press release will prove to be accurate. Except to the extent required by applicable laws or rules, ADMA does not undertake any obligation to update any forward-looking statements or to announce revisions to any of the forward-looking statements. Forward-looking statements are subject to many risks, uncertainties and other factors that could cause our actual results, and the timing of certain events, to differ materially from any future results expressed or implied by the forward-looking statements, including, but not limited to, the risks and uncertainties described in our filings with the U.S. Securities and Exchange Commission, including our most recent reports on Form 10-K, 10-Q and 8-K, and any amendments thereto.

COMPANY CONTACT:

Skyler Bloom

Director, Investor Relations and Corporate Strategy | 201-478-5552 |sbloom@admabio.com

INVESTOR RELATIONS CONTACT:

Michelle Pappanastos

Senior Managing Director, Argot Partners | 212-600-1902 | michelle@argotpartners.com

 

		Three Months Ended June 30,
		2021				2020
REVENUES:
Product revenue		$	17,794,881			$	7,751,885
License revenue			35,709				35,709
Total revenues			17,830,590				7,787,594
OPERATING EXPENSES:
Cost of product revenue (exclusive of amortization expense shown below)			18,832,624				13,495,629
Research and development			1,158,866				1,656,420
Plasma center operating expenses			2,803,326				877,902
Amortization of intangible assets			178,838				178,838
Selling, general and administrative			10,438,168				8,702,630
Total operating expenses			33,411,822				24,911,419
LOSS FROM OPERATIONS			(15,581,232	)			(17,123,825	)
OTHER INCOME (EXPENSE):
Interest income			5,926				19,411
Interest expense			(3,246,680	)			(3,067,306	)
Other expense			(83,317	)			(6,371	)
Other expense, net			(3,324,071	)			(3,054,266	)
NET LOSS		$	(18,905,303	)		$	(20,178,091	)
BASIC AND DILUTED LOSS PER COMMON SHARE		$	(0.15	)		$	(0.23	)
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING:
Basic and Diluted			127,416,126				86,347,467

		June 30, 2021				December 31, 2020
ASSETS
Current assets:
Cash and cash equivalents		$	42,408,958			$	55,921,152
Accounts receivable, net			23,544,594				13,237,290
Inventories			99,699,743				81,535,599
Prepaid expenses and other current assets			5,701,863				3,046,466
Total current assets			171,355,158				153,740,507
Property and equipment, net			46,486,980				41,593,090
Intangible assets, net			2,086,445				2,444,121
Goodwill			3,529,509				3,529,509
Right to use assets			6,829,040				4,259,191
Deposits and other assets			2,526,660				2,106,976
TOTAL ASSETS		$	232,813,792			$	207,673,394
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable		$	6,167,465			$	11,073,708
Accrued expenses and other current liabilities			11,490,239				8,365,143
Current portion of deferred revenue			142,834				142,834
Current portion of lease obligations			385,858				365,682
Total current liabilities			18,186,396				19,947,367
Senior notes payable, net of discount			93,877,017				92,968,866
Deferred revenue, net of current portion			2,047,281				2,118,698
Lease obligations, net of current portion			7,073,415				4,334,151
Other non-current liabilities			36,151				54,886
TOTAL LIABILITIES			121,220,260				119,423,968
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS' EQUITY
Preferred Stock, $0.0001 par value, 10,000,000 shares authorized, no shares issued and outstanding			-				-
Common Stock - voting, $0.0001 par value, 300,000,000 and 150,000,000 shares authorized, 131,872,026 and 104,902,888 shares issued and outstanding			13,187				10,490
Additional paid-in capital			489,330,692				428,704,039
Accumulated deficit			(377,750,347	)			(340,465,103	)
TOTAL STOCKHOLDERS' EQUITY			111,593,532				88,249,426
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY		$	232,813,792			$	207,673,394