UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 2.02 | Results of Operations and Financial Condition |
On May 12, 2021, ADMA Biologics, Inc. issued a press release announcing its financial results for the three months ended March 31, 2021 and providing an overview of recent progress and accomplishments. A copy of the press release is furnished herewith as Exhibit 99.1.*
| Item 9.01 | Exhibits. |
(d) Exhibits
| Exhibit No. | Description |
| 99.1 | ADMA Biologics, Inc. Press Release, dated May 12, 2021 |
* The information in Item 2.02 of this Form 8-K shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| May 12, 2021 | ADMA Biologics, Inc. | ||
| By: | /s/ Brian Lenz | ||
| Name: | Brian Lenz | ||
| Title: | Executive Vice President and Chief Financial Officer | ||
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ADMA Biologics Reports First Quarter 2021 Financial Results and Highlights Recent Company Progress and Accomplishments
Achieved First Quarter 2021 Total Revenues of $16.0 Million, a 57% Increase Over First Quarter 2020
Significantly Expanded Total Asset Value to $235.7 Million, Including $94.1 Million in Inventories
Management to Host Conference Call and Webcast Today at 4:30 p.m. ET
RAMSEY, NJ and BOCA RATON, FL – May 12, 2021 – ADMA Biologics, Inc. (Nasdaq: ADMA) (“ADMA” or the “Company”), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today reported financial results for its fiscal first quarter 2021 and provided an overview of recent progress and accomplishments.
“ADMA has successfully transformed its business in the early months of 2021 and in doing so set the stage for what the Company expects to be a strong year of growth and achievements. We remain on track to deliver on several strategic and financial objectives over the near term, and visibility is improving on the Company’s path to profitability,” said Adam Grossman, President and Chief Executive Officer of ADMA Biologics. “We achieved multiple milestones across business segments during the quarter, while at the same time delivered on operating commitments to shareholders, specifically, generating record quarterly revenues of $16.0 million, a 57% increase over the same period last year. Also on the financial front, ADMA successfully narrowed both gross losses as well as net losses compared to the prior quarter, an encouraging trend the Company will strive to continue in the coming quarters and accelerate throughout 2022.”
ADMA additionally grew its total asset value to a quarter-end balance of $235.7 million, up approximately 13% compared to the year-end 2020 total asset value of $207.7 million. The growth in asset value notably includes approximately $94.1 million in inventories recorded at the Company’s cost, which ADMA expects will support continued production ramp-up as well as quarter-over-quarter revenue growth throughout 2021, and to ensure continuity of product supply into an increasingly supply-constrained immune globulin market.
Mr. Grossman continued, “ADMA substantially strengthened its supply chain during the first quarter of 2021, making significant progress towards its objective to establish end-to-end control of its production operations. Of note, the recent U.S. Food and Drug Administration (“FDA”) approval of the Company’s Intravenous Immune Globulin (“IVIG”) production scale expansion is expected to increase total manufacturing production capacity by up to 50% compared to the Company’s prior expectations, ADMA BioCenters remains on track to have 10 or more plasma collection facilities in operation by 2024, and the two fiscal quarter extension of ADMA’s existing third-party plasma supply commitment to year-end 2022 is expected to further supplement ADMA’s growing internal plasma collections and support the Company in meeting all ongoing, as well as the forecasted, peak IVIG production requirements.”
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“The milestones achieved during the first quarter of 2021 establish a strong foundation for ADMA’s continued execution as the year progresses. We believe the multi-year remediation and production enhancement objectives will enable ADMA to yield significant returns in the way of margin improvements, and to generate anticipated quarter-over-quarter revenue growth which we expect should continue throughout 2021 and beyond. The pathway to profitability is clearly in focus. We believe that we have executed on all stated commitments to our shareholders and to a large extent de-risked future growth prospects as a result of the Company’s achievements during the first quarter. These achievements could not have been completed without the dedication and focus of ADMA’s staff and we commend the entire team for their extraordinary efforts,” concluded Mr. Grossman.
Select First Quarter 2021 Achievements & Recent Corporate Developments:
| · | Continued Commercial Execution: Achieved first quarter 2021 total revenues of $16.0 million, compared to $10.2 million for the first quarter of 2020, reflecting a 57% increase. |
| · | Inventories Continued to Increase to Support Anticipated Quarter-Over-Quarter Revenue Growth. Grew inventories to a first quarter 2021 ending balance of $94.1 million compared to $52.3 million in the first quarter of 2020, which supports our anticipated quarter-over-quarter revenue growth in 2021 and beyond. This inventory consists of raw materials, including source plasma, work-in-process and finished goods. |
| · | Strengthened Internal and Externally Sourced Plasma Supply. ADMA currently has seven plasma collection facilities under its corporate umbrella at various stages of approval and development, including four facilities that are currently operational and collecting plasma, and remains on track to achieve its stated goal of operating 10 or more plasma collection centers by 2024. Over the remainder of 2021, ADMA anticipates to receive approval for one facility presently pending a Biologics License Application (“BLA”), and expects filing BLAs for two additional plasma collection centers. The Company additionally announced an extension of its existing third-party source plasma supply agreement from June 2022 previously through December 2022. We believe ADMA’s growing internal plasma collection network coupled with its contractually committed third-party supply obligations position the company well to ensure sufficient quantities of plasma supply to meet both ongoing production requirements as well as the supply needs associated with the upwardly revised peak annual production capacity expectations of up to 600,000-liters. |
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| · | Advanced Supply Chain Enhancement Initiative. The recent FDA approval of the 4,400-liter IVIG plasma pool scale increase for BIVIGAM® will enable ADMA to potentially ramp-up to 600,000-liters of annual production throughput, realize meaningful gross margin improvement as production throughput flows through the standard 7 to 12-month manufacturing cycle for plasma-derived therapies, and allow ADMA to offer BIVIGAM® in two vial sizes, both the 50 mL and 100 mL configurations. The next anticipated regulatory decision as a part of ADMA’s supply chain enhancement initiative will be for the installed VanRx SA25 Workcell aseptic fill-finish machine (“VanRx”). Based on recent correspondence with the FDA, a facility site inspection (virtual or in-person per current published FDA guidance) will be required prior to approval, the timing of which will be contingent on COVID-19 policies. ADMA is actively working with the FDA to find a way to expedite the plant inspection, and the Company sees a potential pathway for receiving approval during the fourth quarter of 2021. Importantly, the potential regulatory delay has no impact on the Company’s near-term or ongoing operating targets, and ADMA remains confident in its ability to receive FDA approval of its in-house fill-finish machine. |
| · | Improved ASCENIV’s Coverage and Patient Access. Permanent J-code was implemented April 1, 2021, which will provide for a streamlined and permanent reimbursement process in outpatient treatment settings. |
| · | Launched ADvantage Ig Comprehensive Patient Support Program. ADvantage Ig is a comprehensive patient support program designed to help prevent potential barriers to providers obtaining access to ADMA’s therapies for their patients. The launch of this comprehensive patient support program allows for a singular point of contact for patients and providers. |
| · | Lobbied Stakeholders in the Fight Against Sexually Transmitted Diseases. Presented a poster highlighting the pharmacoeconomic burden of human immunodeficiency virus (“HIV”) and Hepatitis B virus (“HBV”) infection in sexual assault patients at the 2021 Academy of Managed Care Pharmacy virtual annual meeting. The Company’s analysis suggests that amending U.S. Centers for Disease Control and Prevention guidelines in this at-risk population for HBV to mirror those of HIV and specifically mandating a Hepatitis B Globulin intervention such as ADMA’s Nabi-HB® hyperimmune, will provide a cost-effective strategy for prophylactic seroprotection of these vulnerable patients. |
First Quarter 2021 Financial Results
Total revenues for the quarter ended March 31, 2021 were $16.0 million, compared to $10.2 million for the quarter ended March 31, 2020, representing an increase of approximately $5.8 million, or 57%. The revenue growth for the first quarter of 2021, compared to the first quarter of 2020, was favorably impacted by the continued commercial ramp up of our IVIG product portfolio.
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Consolidated net loss for the quarter ended March 31, 2021 was $18.4 million, or $(0.16) per basic and diluted share, compared to a consolidated net loss of $19.2 million, or $(0.26) per basic and diluted share, for the quarter ended March 31, 2020. The $0.8 million narrowing in net loss compared to the prior year period was primarily attributable increased revenues and improved gross margins.
At March 31, 2021, ADMA had cash and cash equivalents of approximately $62.0 million and accounts receivable of $15.4 million, compared to cash and cash equivalents of $55.9 million and accounts receivable of $13.2 million as of December 31, 2020. ADMA’s net working capital as of March 31, 2021 was $156.1 million, compared to $133.8 million as of December 31, 2020.
Conference Call Information
ADMA will host a conference call today, May 12, 2021, at 4:30 p.m. Eastern Time, to discuss the fiscal first 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 1063675. 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 Biologics and its products can be found on the Company’s website at www.admabiologics.com.
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 in April 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 ADMA’s unique, patented plasma donor screening methodology and tailored plasma pooling design, which blends normal source plasma and respiratory syncytial virus (RSV) plasma obtained from donors tested using the Company’s proprietary microneutralization assay. ASCENIV contains naturally occurring polyclonal antibodies, which are proteins that are used by the body’s 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. Certain data and other information about ASCENIV™ or ADMA Biologics and its products can be found on the Company’s website at www.admabiologics.com.
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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 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 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 Biologics 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.
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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 meaningful gross margin improvement; BIVIGAM® 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 inspection and approval of our VanRx aseptic fill finish machine; and our continued evaluation of opportunities to expand our pipeline and future product offerings. 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:
Sam Martin
Managing Director, Argot Partners | 212-600-1902 | sam@argotpartners.com
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ADMA BIOLOGICS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
| Three Months Ended March 31, | ||||||||
| 2021 | 2020 | |||||||
| REVENUES: | ||||||||
| Product revenue | $ | 16,012,910 | $ | 10,164,036 | ||||
| License revenue | 35,708 | 35,708 | ||||||
| Total revenues | 16,048,618 | 10,199,744 | ||||||
| OPERATING EXPENSES: | ||||||||
| Cost of product revenue (exclusive of amortization expense shown below) | 17,770,122 | 16,829,226 | ||||||
| Research and development | 987,649 | 1,528,738 | ||||||
| Plasma center operating expenses | 2,242,343 | 500,644 | ||||||
| Amortization of intangible assets | 178,838 | 178,838 | ||||||
| Selling, general and administrative | 10,033,915 | 7,932,084 | ||||||
| Total operating expenses | 31,212,867 | 26,969,530 | ||||||
| LOSS FROM OPERATIONS | (15,164,249 | ) | (16,769,786 | ) | ||||
| OTHER INCOME (EXPENSE): | ||||||||
| Interest income | 22,059 | 248,068 | ||||||
| Interest expense | (3,195,750 | ) | (2,717,091 | ) | ||||
| Other expense | (42,001 | ) | (6,421 | ) | ||||
| Other expense, net | (3,215,692 | ) | (2,475,444 | ) | ||||
| NET LOSS | $ | (18,379,941 | ) | $ | (19,245,230 | ) | ||
| BASIC AND DILUTED LOSS PER COMMON SHARE | $ | (0.16 | ) | $ | (0.26 | ) | ||
| WEIGHTED AVERAGE COMMON SHARES OUTSTANDING: | ||||||||
| Basic and Diluted | 115,661,937 | 73,781,507 | ||||||
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ADMA BIOLOGICS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
| March 31, | December 31, | |||||||
| 2021 | 2020 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 61,965,709 | $ | 55,921,152 | ||||
| Accounts receivable, net | 15,362,030 | 13,237,290 | ||||||
| Inventories | 94,146,200 | 81,535,599 | ||||||
| Prepaid expenses and other current assets | 5,802,608 | 3,046,466 | ||||||
| Total current assets | 177,276,547 | 153,740,507 | ||||||
| Property and equipment, net | 44,175,613 | 41,593,090 | ||||||
| Intangible assets, net | 2,265,283 | 2,444,121 | ||||||
| Goodwill | 3,529,509 | 3,529,509 | ||||||
| Right to use assets | 6,197,295 | 4,259,191 | ||||||
| Deposits and other assets | 2,222,781 | 2,106,976 | ||||||
| TOTAL ASSETS | $ | 235,667,028 | $ | 207,673,394 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 12,152,852 | $ | 11,073,708 | ||||
| Accrued expenses and other current liabilities | 8,592,142 | 8,365,143 | ||||||
| Current portion of deferred revenue | 142,834 | 142,834 | ||||||
| Current portion of lease obligations | 317,910 | 365,682 | ||||||
| Total current liabilities | 21,205,738 | 19,947,367 | ||||||
| Senior notes payable, net of discount | 93,412,660 | 92,968,866 | ||||||
| Deferred revenue, net of current portion | 2,082,990 | 2,118,698 | ||||||
| Lease obligations, net of current portion | 6,419,589 | 4,334,151 | ||||||
| Other non-current liabilities | 41,965 | 54,886 | ||||||
| TOTAL LIABILITIES | 123,162,942 | 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, 150,000,000 shares authorized, | ||||||||
| 123,044,981 and 104,902,888 shares issued and outstanding | 12,304 | 10,490 | ||||||
| Additional paid-in capital | 471,336,826 | 428,704,039 | ||||||
| Accumulated deficit | (358,845,044 | ) | (340,465,103 | ) | ||||
| TOTAL STOCKHOLDERS' EQUITY | 112,504,086 | 88,249,426 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 235,667,028 | $ | 207,673,394 | ||||
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