Commercial-stage biopharmaceutical company ADMA Biologics Inc. (ADMA:NASDAQ), which is focused on manufacturing, marketing and developing specialty plasma-derived biologics, today announced that "the U.S. Food and Drug Administration (FDA) has granted approval for the company's expanded manufacturing process, enabling fractionation and purification of a 4,400-liter plasma pool for the manufacture of Intravenous Immune Globulin (IVIG)."
ADMA Biologics' President and CEO Adam Grossman commented, "The FDA approval of the 4,400-liter IVIG plasma pool production scale process is a transformative milestone for the ADMA organization and will allow the company to produce significantly more IVIG for the U.S. market and for patients living with immune deficiencies...The expanded plasma pool production scale allows us to confidently commit to generating peak revenues in excess of $300 million and this approval solidifies the pathway to meaningful gross margin expansion beginning potentially in the second half of 2021 and accelerating throughout 2022."
"In addition to the increase in ADMA's multi-year financial guidance, the company is reiterating its expectation for quarter-over-quarter revenue growth throughout 2021 and beyond," Grossman added.
The company pointed out that the newly authorized 4,400-liter IVIG plasma pool scale for BIVIGAM® will facilitate the expansion of its processing capacity by 50% from 400,000 to 600,000 liters. ADMA believes that it will be able to produce BIVIGAM® utilizing it same equipment, release testing assays, disposables and labor force.
The firm stated that it expects that the higher product output volumes will provide meaningful improvement to its gross margin throughout its 7 to 12 month manufacturing cycle for plasma-derived therapies. The company indicated that after receiving approval to boost production levels from the FDA its now able to distribute BIVIGAM® in both 50 mL and 100 mL vial sizes.
ADMA Biologics develops, manufactures and markets specialty plasma-derived biologics used in the treatment of immunodeficient patients who are at risk for infection and various infectious diseases. The company presently manufactures and sells three FDA-approved plasma-derived biologics, "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."
The company makes its IVIG products at its FDA-licensed facility in Boca Raton, Fla., and additionally operates a FDA-approved source plasma collector through a subsidiary company that provides a portion of its blood plasma for the manufacture of ADMA's products.
ADMA Biologics started the day with a market cap around $233.8 million with approximately 123.0 million shares outstanding and a short interest of about 8.4%. ADMA shares opened 24% higher today at $2.36 (+$0.46, +24.21%) over yesterday's $1.90 closing price. The stock has traded today between $2.06 and $2.63 per share and closed for trading at $2.07 (+$0.17, +8.95%).[NLINSERT]
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases. As of the date of this article, officers and/or employees of Streetwise Reports LLC (including members of their household) own securities of ADMA Bilologics, a company mentioned in this article.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.