Exhibit 99.1

 

 

3Q2022 Total Revenues Were $41.1 Million, a 99% Y-o-Y Increase

 

Grew 3Q2022 Gross Profit to $9.7 Million, a $9.3 Million Y-o-Y Increase

 

Raising FY 2022 Total Revenue Guidance to $145 Million From $130 Million Previously

 

Gross Profit Growth and Narrowing Net Losses Expected into 2023

 

Conference Call Scheduled for Today at 4:30 p.m. ET

“We are pleased to again be raising revenue guidance for full-year 2022; the Company now expects to generate total revenue of approximately $145 million, increased from $130 million as previously provided. We believe that the third quarter revenue growth of 99% year-over-year establishes a strong foundation from which ADMA will continue to generate substantial revenue growth and improve margins as we accelerate towards corporate profitability,” said Adam Grossman, President and Chief Executive Officer of ADMA.

Mr. Grossman continued, “Enabled by this continued revenue growth, we opportunistically undertook several investments during the quarter which we believe will strengthen commercial initiatives, advance growth opportunities and enhance margins moving forward.  Research and development expenditures increased due to accelerated enrollment of the post-marketing clinical study for BIVIGAM. We believe the rapid pace of enrollment and investigator excitement speaks to the reputation ADMA and its products have established in the market.  Additionally, during the quarter, we mobilized a robust medical education and conference symposia strategy which is anticipated to solidify ASCENIV’s growth outlook and further expand the product’s growing customer base to areas not yet penetrated.”

"While we are pleased with our reported gross profit expansion, it is important to note that a substantial portion of BIVIGAM revenues during the third quarter consisted of legacy 2,200-liter scale product, which yields a significantly lower margin compared to the current 4,400-liter batch production scale,” said Brian Lenz, ADMA’s Chief Financial Officer, and General Manager, ADMA BioCenters.  “BIVIGAM inventory at the 2,200-liter scale sold during this quarter was produced during 2021, prior to the Company receiving FDA approval of the 4,400L-liter scale production. Encouragingly, ADMA has been exclusively producing BIVIGAM at the 4,400-liter scale since the second half of 2021. The residual, lower margin inventory produced at the 2,200-liter scale is anticipated to be fully exhausted over the coming quarters and once sold, we believe our profit margins will substantially improve.”

Mr. Grossman concluded, “As we look to 2023, we believe ADMA is well-positioned in its advancement towards profitability.  The immunoglobulin (“IG”) end market remains one of the fastest growing segments in the pharmaceutical sector, and we are proud to have clearly demonstrated ADMA’s staying power within this landscape.  The pieces are in place for ADMA to sustain its best-in-class revenue growth profile and deliver on our longstanding commitment of reaching profitability as rapidly as possible.”

Third Quarter 2022 and Recent Achievements:

 

2022 & Long-Term Financial Guidance:

 

 

Third Quarter 2022 Financial Results:

Gross profit for the third quarter of 2022 was $9.7 million, compared to gross profit of $0.4 million for the third quarter of 2021. Gross profit growth during the third quarter was driven by a favorable contribution from ASCENIV.  Partially offsetting the favorably evolving product mix, ADMA sold a material amount of the remaining 2,200-liter scale, lower margin BIVIGAM product during the third quarter of 2022.  Moving forward, this lower margin inventory is anticipated to be exhausted over the coming quarters, after which production throughput and sales recognition is anticipated to be confined exclusively to the higher margin 4,400-liter BIVIGAM product.

 

 

Net loss decreased by approximately $2.8 million compared to the third quarter of 2021, primarily attributed to higher gross profit of $9.3 million, partially offset by a $2.3 million increase in interest expense as a result of additional debt principal as well as rising interest rates.  Additional offsets during the third quarter of 2022 included increased plasma center operating expenses of $1.7 million attributed to having nine plasma centers in operation compared to five operating centers during the same period last year, as well as increased general and administrative expenses of $2.2 million resulting from increased headcount, commercialization, and marketing expenditures.

 

As of September 30, 2022, ADMA had working capital of approximately $179.7 million, primarily consisting of $162.9 million of inventory, $34.9 million of cash and cash equivalents and net accounts receivable of $20.9 million, partially offset by an aggregate of $43.6 million of accounts payable and accrued expenses.

Conference Call Information

To access the conference call on November 9, 2022 at 4:30 PM ET, participants may register for the call here to receive the dial-in numbers and unique PIN to access the call seamlessly. It is recommended that you join 10 minutes prior to the event starting (although you may register and dial in at any time during the call). 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.

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 cGMP (current good manufacturing practices) 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 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: 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 and European Patent No. 3375789, among others, related to certain aspects of its products and product candidates. For more information, please visit www.admabiologics.com.

 

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, “our”, “ADMA” 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 “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “intends,” “may,” “plans,” “predicts,” “projects,” “should,” “targets,” “will,” “would,” 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 and pro forma results; the success of BIVIGAM^® and ASCENIV™ in future periods, including certain opportunities for such products; the production scale of BIVIGAM; future growth opportunities; the timeline associated with profitability; the ability to obtain FDA approval of its plasma collection centers and the associated timing in connection therewith; expectations regarding the Company’s future gross margins; and the ability to achieve source plasma self-sufficiency and the associated timing in connection therewith, as well as benefits thereof. 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 SEC, including our most recent reports on Form 10-K, 10-Q and 8-K, and any amendments thereto.

COMPANY CONTACT:

Skyler Bloom

Senior Director, Business Development and Corporate Strategy | 201-478-5552 | sbloom@admabio.com

INVESTOR RELATIONS CONTACT:

Michelle Pappanastos

CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

CONDENSED CONSOLIDATED BALANCE SHEETS

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