After U.S. markets closed yesterday afternoon, biopharmaceutical company ADMA Biologics Inc. (ADMA:NASDAQ), which is engaged in the development, manufacture, and marketing of specialty plasma-derived biologics, announced yesterday operating and financial results for the third quarter of 2022 ended September 30, 2022.
ADMA Biologics' President and CEO Adam Grossman led off the report by commenting, "We are pleased to again be raising revenue guidance for FY/22. The company now expects to generate total revenue of approximately US$145M (million), increased from US$130M as previously provided. We believe that the Q3/22 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."
The company's CFO and General Manager of ADMA BioCenters, Brian Lenz, stated, "a substantial portion of BIVIGAM revenues during Q3/22 consisted of legacy 2,200-liter scale product, which yields a significantly lower margin compared to the current 4,400-liter batch production scale…Encouragingly, ADMA has been exclusively producing BIVIGAM at the 4,400-liter scale since H2/21. 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."
ADMA shares opened 12% higher yesterday at US$2.77 (+US$0.30, +12.15%) over Wednesday's US$2.47 closing price and reached a new 52-week high price yesterday morning of US$3.19.
The company discussed some of the highlights from business operations and stated that it achieved significant revenue growth in Q3/22 and has moved toward a more profitable product mix.
The firm noted that it remains focused on reaching profitability by Q1/24.
The firm said that it increased the prescriber and patient base for ASCENIV which resulted in record utilization and pull-through for the product. The company stated that the upward trend is continuing and that it expects demand to rise further in Q4/22 and beyond.
The company indicated that it is following through with its medical education and scientific symposia strategy to target new growth opportunities. One such program is focused on identification of clinical needs and concerns related to the management of respiratory infections in immunocompromised patients.
Additionally, the firm sponsored presentations at several medical conferences by highly respected clinical experts in the areas of immunology, infectious disease, and transplantation.
The company mentioned that its ongoing post-marketing clinical studies are continuing to search for opportunities that would allow for potential label expansion of its BIVIGAM and ASCENIV to include pediatric-aged PI patients.
ADMA pointed out that it remains on-track for its plans to have ten FDA-licensed BioCenters fully operational by YE/23, which will provide the company with self-sufficient supply of raw material plasma required for its operations. ADMA BioCenters collects human plasma that is necessary to make specialty medicines used to prevent and treat various diseases. The company believes that securing a strong and reliable supply of plasma will allow it to meet its upwardly revised production and revenue projections.
The company stated that during Q3/22 total revenues rose by 99% year-over-year to US$$41.1 million, compared to US$20.7 million in Q3/21. The firm noted that the increase was largely attributed to the continued commercial ramp-up of its intravenous immune globulin (IVIG) product portfolio and expansion of its BIVIGAM and ASCENIV customer base.
The firm reported that it registered gross profit of US$9.7 million in Q3/22, versus US$0.4 million in Q3/21. The company mentioned that the increase was due to favorable contribution from ASCENIV which in part offset sales of its lower margin 2,200-liter scale BIVIGAM product.
ADMA said that going forward it expect to see higher gross margins as it exhausts its 2,200-liter BIVIGAM inventory and changes its sales mix to the higher margin 4,400-liter BIVIGAM product.
The company stated for Q3/22 it recorded a net loss of US$14.9 million, or a net loss of US$0.08 per basic and diluted share, versus a net loss of US$17.7 million, or a net loss of US$0.13 per share in Q3/21.
The company provided some forward guidance and stated that for FY/22 it expects total revenues of US$145 million. The firm advised that looking ahead to FY/23 it is reiterating its expectations for continued improvements in gross profit and lower net losses.
ADMA stated that for FY/24 it anticipates that it will post revenues of US$250 million or higher. The firm added than in FY/25 and thereafter, it expects that revenues will increase to US$300 million or more.
The company listed that it forecasts that starting in FY/24, and continuing into FY/25, gross margins are expected to be in the range of 40-50% and net income margins should be in the range of 20-30%.
ADMA advised that based upon these assumptions during FY/24 and FY/25 it estimates that it will register yearly gross profit of US$100-150 million and net income of US$50-100 million.
The firm explained that its "ASCENIV™ (immune globulin intravenous, human – slra 10% liquid) is a plasma-derived, polyclonal, intravenous immune globulin (IVIG)." The company advised that the U.S. Food and Drug Administration (FDA) granted approval for ASCENIV in April 2019 for use in treating primary humoral immunodeficiency (PI), which is also referred to as primary immune deficiency disease (PIDD), in those 12 years of age and older.
The company described BIVIGAM® (immune globulin intravenous, human – 10% liquid) as "a plasma-derived, polyclonal, intravenous immune globulin (IVIG)." The FDA issued approval for BIVIGAM in May 2019 for use it the treatment of primary humoral immunodeficiency (PI). Importantly, the company mentioned that "BIVIGAM contains a broad range of antibodies similar to those found in normal human plasma that are directed against bacteria and viruses and helps to protect PI patients against serious infections."
ADMA Biologics is an end-to-end, commercial-stage biopharmaceutical company that develops, manufactures, and markets specialty plasma-derived biologics that are used to treat immunodeficient individuals who are at high risk for infection and infectious diseases. ADMA Biologics is based in Ramsey, N.J., and has FDA-licensed manufacturing operations in Boca Raton, Fla., where it manufactures its IVIG products.
The company currently has three FDA-licensed approved products called ASCENIV™, BIVIGAM®, and NABI-HB®. These products are all plasma-derived human immune globulins that are designed to target, treat, and prevent specific infectious diseases in a niche group of immune-compromised patients.
ADMA Biologics started yesterday with a market cap of around US$485.0 million, with approximately 196.36 million shares outstanding and a short interest of about 13.1%. ADMA shares opened 12% higher yesterday at US$2.77 (+US$0.30, +12.15%) over Wednesday's US$2.47 closing price and reached a new 52-week high price yesterday morning of US$3.19. The stock traded yesterday between US$2.71 and US$3.19 per share and closed for trading at US$3.15 (+US$0.68, +27.53%).
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