GlobeNewswire Inc | Aug 5, 2020 04:05PM EDT

August 05, 2020

Generated Total Revenues of $18.0 Million for the First Half of 2020, Reflecting a 78% Increase Over First Half of 2019

Joined CoVIg-19 Plasma Alliance and Successfully Opened New ADMA BioCenters Plasma Collection Center

Company Anticipates Generating $250 Million or More in Annual Revenues Within Next Three to Five Calendar Years

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

RAMSEY, N.J. and BOCA RATON, Fla., Aug. 05, 2020 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq: ADMA) (ADMA), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today reported business highlights and financial results for its fiscal second quarter and six months ended June 30, 2020, and provided an overview of recent progress and accomplishments.

The first half of 2020 was marked by several achievements and challenges as we navigate through these unprecedented macro-market conditions, said Adam Grossman, President and Chief Executive Officer of ADMA. Total revenues for the first half of 2020 increased approximately 78% compared to the same prior year period. While the second quarter 2020 revenues were approximately 19% higher than second quarter 2019 revenues, ADMA, and certain of its third-party vendors, experienced impacts from the global COVID-19 pandemic which resulted in unforeseen supply chain disruptions. These COVID-19 disruptions were primarily related to delays with final product Current Good Manufacturing Practice (cGMP) release testing by third-party vendors. This means that a few of our production batches were finished on schedule but we were unable to submit for U.S. Food and Drug Administration (FDA) lot release authorization due to delayed test results.

These delays were mainly experienced during the latter part of the second quarter and have since been resolved during July. In response to these delays, and in partnership with the FDA, we added additional release testing laboratories to our approved consortium and believe we have completely resolved the issue and do not anticipate additional testing or batch release delays going forward.

Market demand for our immunoglobulin product portfolio remains strong and we anticipate considerable revenue growth for the second half of the year and are excited for the anticipated production volume increases from our capacity expansion efforts in 2021 and beyond. We also believe we remain on track to achieve our stated goal of generating $250 million or more in annual revenues within the next three to five calendar years.

In accordance with our stated corporate objectives, during the quarter we completed construction of a new plasma collection center, initiated donor collections and submitted a Biologics License Application (BLA) to the FDA, with an approval decision expected in mid-2021. We also installed and qualified a new aseptic fill-finish machine at our Boca Raton facility, and manufactured conformance batches of BIVIGAM at an increased scale that will ultimately allow us to manufacture at twice the volume as the process that is in place today. And finally, we joined the CoVIg-19 Plasma Alliance and began collection of plasma from COVID-19 convalesced patients. We are proud of these important achievements and milestones and believe we have set the stage to now be in a position to ensure the U.S. market has a continuous supply of BIVIGAM, ASCENIV and NABI-HB. We are on target for positioning our operations to capitalize on the continued forecasted growth of the plasma products industry. Our production throughput and finished product supply remains on track to begin realizing the benefits from these initiatives as early as mid-2021, concluded Mr. Grossman.

Second Quarter 2020 Highlights and Recent Events

-- Plasma Collection Centers ADMA BioCenters, a wholly-owned subsidiary of ADMA Biologics, successfully opened, began donor collections and filed a BLA to receive FDA approval for its second plasma collection center. ADMA expects to open a third U.S. collection center and commence construction on a fourth center by the end of 2020 and remains on track to deliver on its stated milestone of opening five to ten new plasma collection centers over the next three to five years. -- Plasma Industry Alliance ADMA recently joined the CoVIg-19 Plasma Alliance, an unprecedented plasma industry collaboration established to accelerate the development of a plasma-derived hyperimmune globulin therapy for COVID-19. As an Alliance member company, ADMA, through its ADMA BioCenters subsidiary, has initiated collecting and providing COVID-19 plasma from convalesced patients. This plasma will be used by the CoVIg-19 Plasma Alliance to produce a COVID-19 targeted hyperimmune globulin, as well as for internal research and development purposes. -- Manufacturing Capacity Expansion Initiatives ADMA successfully implemented several manufacturing and supply chain enhancements, including the purchase and installation of a new Vanrx SA25 Workcell aseptic filling machine and manufacturing of four conformance batches of BIVIGAM at an increased scale. These important initiatives are designed to reduce operating costs, improve margins and provide for faster production cycle turnaround time, ultimately providing increased control and independence from third-party vendors and contractors. ADMA plans to submit the appropriate applications to the FDA during the second half of 2020, and expects to begin benefitting from these initiatives as early as mid-2021.

COVID-19 Impacts

-- Final Product Release Testing ADMA experienced delays with final product release testing for its commercial products due to COVID-19s impact on third-party laboratories that perform the FDA-required cGMP release testing. These testing delays prevented ADMA from receiving FDA authorization to sell additional completed production batches during the second quarter. ADMA believes this delay was completely resolved in July 2020. In response to these delays, and in collaboration with the FDA, ADMA secured additional third-party laboratories, which has completely resolved this specific testing backlog. ADMA received FDA authorized product releases with data from its new third-party testing laboratories during July. Going forward, ADMA believes access to these additional laboratories will provide more rapid final product release testing as well as more consistent receipt of testing results to submit to the FDA for final product releases. -- Supply Chain Impacts Due to COVID-19 As a result of previous state and local shelter-in-place orders, ADMA experienced lower than normal donor collections at its FDA-licensed plasma collection center during the second quarter of 2020. ADMA also experienced delayed timing of shipments of source plasma from its contracted third-party suppliers, as well as delays in deliveries of personal protective equipment, reagents and other non-plasma raw materials and supplies used in the manufacture of its products. -- Commercial Engagement Opportunities ADMA observed impacts to its customer engagement initiatives as its sales and medical affairs field forces experienced difficulty communicating directly with physicians and other healthcare professionals. In addition, a number of key scientific and medical meetings were either canceled or postponed, further limiting ADMAs ability to communicate with potential customers. ADMA has implemented a comprehensive suite of virtual engagement initiatives; however, clinician engagement has been reduced due to rapidly evolving COVID-19 priorities at U.S. medical centers.

Financial Results for the Three Months Ended June 30, 2020

Total revenues for the quarter ended June 30, 2020 were $7.8 million, compared to $6.6 million for the quarter ended June 30, 2019, representing an increase of approximately $1.2 million, or approximately 19%. The increase is primarily due to sales of BIVIGAM, ASCENIV and intermediates, compared to no sales from these products during the same prior year period. ADMAs revenues for the second quarter of 2020, compared to the second quarter of 2019, were favorably impacted by the FDA approvals of BIVIGAM and ASCENIV on May 9, 2019 and April 1, 2019, respectively, and by the manufacturing and supply agreement ADMA entered into in January 2020 to produce and sell intermediate fractions to a certain customer.

Consolidated net loss for the quarter ended June 30, 2020 was $20.2 million, or $(0.23) per basic and diluted share, compared to a consolidated net loss of $13.2 million, or $(0.25) per basic and diluted share, for the quarter ended June 30, 2019. The increase in net loss of $7.0 million was primarily due to increased cost of product revenue of $3.0 million related to sales of FDA-approved immunoglobulin products not present in the same prior year period, along with the remaining costs associated with the manufacturing of BIVIGAMs increased plasma pool conformance lots as part of our planned capacity expansion, partially offset by a decrease in unabsorbed manufacturing expense at the Boca Raton, FL production facility. The increase in net loss during the second quarter of 2020 is also attributable to higher research and development expenses of $1.1 million, largely due to costs associated with the testing and development of a new filling line at one of our third-party fill finishers, and to increased selling, general and administrative expenses of $2.6 million, mainly due to increases in employee compensation expenses and other costs in support of our commercialization efforts for BIVIGAM and ASCENIV. In addition, interest expense for the quarter increased by $1.0 million due to our accessing additional debt during the second quarter of 2019 and first quarter of 2020. Included in the net loss for the second quarter of 2020 were non-cash expenses of approximately $2.0 million for stock-based compensation, depreciation and amortization, and non-cash interest expense.

Financial Results for the Six Months Ended June 30, 2020

Total revenues for the six months ended June 30, 2020 were $18.0 million, compared to $10.1 million for the six months ended June 30, 2019, representing an increase of $7.9 million, or approximately 78%. The increase in revenues was primarily attributable to sales of BIVIGAM, ASCENIV and intermediates, compared to no sales from these products during the same prior year period.

Consolidated net loss for the six months ended June 30, 2020 was $39.4 million, or $(0.49) per basic and diluted share, compared to a consolidated net loss of $26.3 million, or $(0.53) per basic and diluted share, for the six months ended June 30, 2019. The increase in net loss of $13.1 million was primarily attributable to increased cost of product revenue of $10.4 million related to sales of BIVIGAM, ASCENIV and intermediates not present during the first half of 2019, along with the costs associated with the manufacturing of BIVIGAMs increased plasma pool conformance lots as part of our planned capacity expansion, along with other production initiatives and investments at the Boca Raton facility. Other factors contributing to the increase in net loss include: higher research and development expenses attributed to costs associated with testing and development of a new fill line at our third-party fill finisher and costs incurred for a study we commenced to potentially extend ASCENIVs approved and labeled expiration dating, higher selling, general administrative expenses in support of our commercialization efforts of BIVIGAMs relaunch and ASCENIVs launch and the overall growth in the size and scope of the Companys operations along with higher interest expense due to accessing additional debt during the second quarter of 2019 and first quarter of 2020. Included in the net loss for the first half of 2020 were non-cash expenses of approximately $3.9 million for stock-based compensation, depreciation and amortization, and non-cash interest expense.

At June 30, 2020, ADMA had cash and cash equivalents of $75.8 million and accounts receivable of $6.5 million, compared to cash and cash equivalents of $26.8 million and accounts receivable of $3.5 million at December 31, 2019. ADMAs net working capital as of June 30, 2020 was $130.1 million, compared to $71.8 million as of December 31, 2019.

Conference Call Information

ADMA will host a conference call today, Wednesday, August 5, 2020, at 4:30 p.m. Eastern Time, to discuss the second quarter 2020 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 8992308. 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 (IgG) antibodies.

About ASCENIV

ASCENIV (immune globulin intravenous, human slra 10% liquid) is a plasma-derived, polyclonal, intravenous immune globulin (IVIG). ASCENIV was approved by the FDA on April 1, 2019 and is indicated for the treatment of primary humoral immunodeficiency (PI), also known as primary immune deficiency disease (PIDD), in adults and adolescents (12 to 17 years of age). ASCENIV is manufactured using ADMAs unique, patented plasma donor screening methodology and tailored plasma pooling design, which blends normal source plasma and plasma from donors tested using the Companys proprietary microneutralization assay. ASCENIV contains naturally occurring polyclonal antibodies, which are proteins that are used by the bodys immune system to neutralize microbes, such as bacteria and viruses and prevent against infection and disease. ASCENIV is protected by U.S. Patents: 9,107,906, 9,714,283 and 9,815,886.

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 Biologics and its products can be found on the Companys website at www.admabiologics.com.

About ADMA BioCenters

ADMA BioCenters is an FDA licensed facility 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 cGMP (current good manufacturing practices) in all of its facilities. For more information about ADMA BioCenters, please visit www.atlantaplasma.com.

About ADMA Biologics, Inc. (ADMA)

ADMA Biologics is an end-to-end 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 United States Food and Drug Administration (FDA) approved plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases: ASCENIV (immune globulin intravenous, human slra 10% liquid) for the treatment of primary humoral immunodeficiency (PI); BIVIGAM (immune globulin intravenous, human) 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 Bio Centers 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. ADMAs 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. (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 ADMAs future results of operations, including the goal of generating $250 million or more in annual revenues within the next three to five calendar years; our belief that we have corrected third-party release testing delay issues through the addition of release testing laboratories to our FDA-approved consortium; the outcome and timing of our BLA application for our new plasma center; the expected benefits from the new aseptic fill-finish machine installed at our Boca Raton facility; the continued forecasted growth of the plasma products industry and our expectation to capitalize thereon; the construction and opening of plasma collection centers and the timing thereof; the expected and intended use by the CoVIg-19 Plasma Alliance of plasma that we collect; the benefits expected from our several manufacturing and supply chain enhancement, the expected timing for realizing those benefits, and our plan to submit appropriate applications to the FDA related thereto; and the expected benefits from securing additional third-party laboratories to perform cGMP release testing. Actual events or results may differ materially from those described in this document 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:

Brian Lenz

Executive Vice President and Chief Financial Officer | 201-478-5552 |www.admabiologics.com

INVESTOR RELATIONS CONTACT:

Sam Martin

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

ADMA BIOLOGICS, INC. AND SUBSIDIARIESCONSOLIDATED STATEMENTS OF OPERATIONS

Three Months Ended June 30, Six Months Ended June 30, 2020 2019 2020 2019 REVENUES: Product $ 7,751,885 $ 6,525,233 $ 17,915,921 $ 10,018,114 revenueLicense 35,709 35,709 71,417 71,417 revenueTotal Revenues 7,787,594 6,560,942 17,987,338 10,089,531 OPERATING EXPENSES:Cost ofproductrevenue(exclusive of 13,495,629 10,491,236 30,324,855 19,896,415 amortizationexpense shownbelow)Research and 1,656,420 516,986 3,185,158 1,387,621 developmentPlasma centeroperating 877,902 594,113 1,378,546 1,248,599 expensesAmortizationof intangible 178,838 211,234 357,676 422,469 assetsSelling,general and 8,702,630 6,086,047 16,634,714 11,681,517 administrativeTotaloperating 24,911,419 17,899,616 51,880,949 34,636,621 expenses LOSS FROM (17,123,825 ) (11,338,674 ) (33,893,611 ) (24,547,090 )OPERATIONS OTHER INCOME (EXPENSE):Interest and 19,411 209,808 267,479 337,207 other incomeInterest (3,067,306 ) (2,072,578 ) (5,784,397 ) (3,613,085 )expenseLoss onextinguishment - - - (9,962,495 )of debtGain ontransfer of - - - 11,527,421 plasma centerassetsOther expense, (6,371 ) (10,428 ) (12,792 ) (21,785 )netOther expense, (3,054,266 ) (1,873,198 ) (5,529,710 ) (1,732,737 )net NET LOSS $ (20,178,091 ) $ (13,211,872 ) $ (39,423,321 ) $ (26,279,827 ) BASIC ANDDILUTED LOSS $ (0.23 ) $ (0.25 ) $ (0.49 ) $ (0.53 )PER COMMONSHARE WEIGHTEDAVERAGE COMMON SHARESOUTSTANDING:Basic and 86,347,467 52,206,204 80,064,641 49,295,805 Diluted

ADMA BIOLOGICS, INC. AND SUBSIDIARIESCONDENSED CONSOLIDATED BALANCE SHEETS

June 30, December 31, 2020 2019ASSETS (Unaudited) Current assets: Cash and cash equivalents $ 75,781,122 $ 26,752,135 Accounts receivable, net 6,514,165 3,469,919 Inventories 56,001,348 53,064,734 Prepaid expenses and other current 4,693,427 2,533,593 assetsTotal current assets 142,990,062 85,820,381 Property and equipment, net 37,373,366 31,741,317 Intangible assets, net 2,801,797 3,159,474 Goodwill 3,529,509 3,529,509 Deposits and other assets 4,846,834 2,840,044 TOTAL ASSETS $ 191,541,568 $ 127,090,725 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 6,909,659 $ 9,174,591 Accrued expenses and other current 5,616,666 4,481,395 liabilitiesCurrent portion of deferred revenue 142,834 142,834 Current portion of lease obligations 210,870 229,073 Total current liabilities 12,880,029 14,027,893 Senior notes payable, net of discount 81,648,187 68,291,163 Deferred revenue, net of current 2,190,115 2,261,532 portionSubordinated note payable, net of 14,925,760 14,908,053 discountLease obligations, net of current 2,937,292 1,302,361 portionOther non-current liabilities 80,730 106,574 TOTAL LIABILITIES 114,662,113 100,897,576 COMMITMENTS AND CONTINGENCIES STOCKHOLDERS' EQUITY Preferred Stock, $0.0001 par value,10,000,000 shares authorized, no - - shares issued and outstandingCommon Stock, $0.0001 par value,150,000,000 shares authorized, 8,635 5,932 86,349,981 and 59,318,355 sharesissued and outstandingAdditional paid-in capital 381,010,696 290,903,772 Accumulated deficit (304,139,876 ) (264,716,555 )TOTAL STOCKHOLDERS' EQUITY 76,879,455 26,193,149 TOTAL LIABILITIES AND STOCKHOLDERS' $ 191,541,568 $ 127,090,725 EQUITY