Fly Intel: After-Hours Movers » 18:4808/0508/05/20
ARLO, BFAM, APPS, OTRK, PBPB, GMED, HUBS, MRCC, NUS, ZNGA, TRMB, AVCT, RBBN, AVXL, OSUR, ADMA, FSLY, QUIK, WDC, ZIXI, ADT, OLN, IO, LNC, ROKU, MET
Check out this evening's…
ADMA Biologics reports Q2 EPS (23c), consensus (16c) » 16:4108/0508/05/20
Reports Q2 revenue…
Reports Q2 revenue $7.79M, consensus $10.57M. "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.
|Over a month ago|
ADMA Biologics commences operations at plasma collection facility, submits BLA » 07:2007/0607/06/20
ADMA Biologics announced…
ADMA Biologics announced the commencement of operations and initiation of collections at its newest ADMA BioCenters plasma collection facility located in Knoxville, Tennessee. ADMA also announced that it has submitted a biologics license application, or BLA, to the FDA seeking approval for this second plasma collection center. This new, state-of-the-art plasma collection center features automated registration, collection equipment designed to shorten the donation process, free Wi-Fi wireless network in the donor collection area, individual flat screen TVs with cable at each donor station, and certified staff who put donor comfort and safety first. The FDA regulatory process for obtaining approval for this plasma collection center includes a site inspection and an approximately 12-month BLA review period. As such, ADMA expects to receive an approval decision for this second plasma facility in mid-2021. In the meantime, ADMA is permitted to collect plasma donations at this site, and once FDA approved, it can use the plasma collected for production of its FDA approved immunoglobulin products.
ADMA Biologics appoints Martha Demski to board of directors » 07:1206/2306/23/20
ADMA Biologics announced…
ADMA Biologics announced that the proposed resolution to elect Martha Demski to its Board of Directors was approved at the Company's recent Annual Shareholder Meeting, held June 18, 2020. Demski was SVP and CFO of Ajinomoto Althea.
ADMA rises as 60 Minutes teases segment on 'Promise of Plasma' » 10:1205/2905/29/20
On its program airing…
On its program airing Sunday, May 31, CBS News' 60 Minutes will feature a segment titled "The Promise of Plasma," in which Bill Whitaker reports on "how doctors are taking the blood plasma of COVID-19 survivors, and the virus-fighting antibodies in it, to create the life-saving therapy." The Fly notes that on May 21, ADMA Biologics announced it has commenced the collection of convalescent plasma through its wholly-owned subsidiary, ADMA BioCenters Georgia, from individuals who have recovered from COVID-19. "Immune globulin is a plasma-derived medicine that is comprised of polyclonal antibodies and is routinely used for the prevention and treatment of certain infectious diseases. Currently, six producers of immune globulin, including ADMA Biologics, supply products to the US market," the company stated at that time. In early Friday morning trading, ADMA shares are up 31c, or 11%, to $3.18. Reference Link
ADMA Biologics' use of plasma is 'oldest trick in pandemic playbook', says Maxim » 08:1805/2605/26/20
ADMA, GILD, MRNA
Maxim analyst Jason…
Maxim analyst Jason McCarthy keeps his Buy rating and $6 price target on ADMA Biologics (ADMA), saying the potential of the company's announced plasma collection to tread COVID-19 has gone relatively unnoticed when compared to Moderna's (MRNA) vaccine efforts and Gilead's (GILD) anti-viral development. The analyst adds that the use of convalescent plasma as the "oldest trick in the pandemic playbook" could be the answer in a world that needs help fast, and sees the use of hyperimmune plasma from patients that have recovered as a potentially simple and powerful approach to treat COVID-19.
ADMA Biologics begins collection of COVID-19 plasma from recovered patients » 07:1405/2105/21/20
ADMA Biologics announced…
ADMA Biologics announced it has commenced the collection of convalescent plasma through its wholly-owned subsidiary, ADMA BioCenters Georgia, from individuals who have recovered from COVID-19. ADMA 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 is seeking US citizens who have recovered from coronavirus or COVID-19, to donate plasma, which can be used to produce an immune globulin to potentially help infected patients with COVID-19. People who have recovered from COVID-19 can have antibodies in their plasma that may be helpful in treating the virus. Immune globulin is a plasma-derived medicine that is comprised of polyclonal antibodies and is routinely used for the prevention and treatment of certain infectious diseases. Currently, six producers of immune globulin, including ADMA Biologics, supply products to the US market.
|Over a quarter ago|
ADMA anticipates FDA submissions for increased production of BIVIGAM in 2H20 » 08:5805/0705/07/20
ADMA Biologics announced…
ADMA Biologics announced several recent corporate achievements pertaining to its supply chain robustness objectives as established at the beginning of 2020. "We have been very active during these challenging times in executing upon what we believe to be high value-added improvements to our supply chain to enhance robustness, increase capacity and heighten control over the production of our products. These achievements include the successful manufacturing of three BIVIGAM conformance batches at an increased scale of plasma volume, purchase of a new aseptic filling machine and installation, along with our plasma collection center expansion initiatives, all of which are on schedule with our budgeted expectations. These important accomplishments are in-line with our 2020 corporate goals and are designed to enhance shareholder valued by reducing operating costs, improve margins and provide for faster turnaround time in the production cycle of our commercial immunoglobulin products," stated Adam Grossman, President and Chief Executive Officer. "We believe these additional capabilities will also allow us to provide a broader range of high-quality services, both to our existing customers, as well as potential new clients and ultimately provide increased control and independence from vendors and contractors as we grow our Company." The conformance batch production for BIVIGAM is at double the plasma volume of the currently U.S. Food and Drug Administration approved process for the manufacture of immune globulin. There have been no significant changes to the manufacturing process, in-process controls or final release testing other than validating the effectiveness of the ADMA manufacturing process at the larger scale. At the newly increased scale, we observed the same potency and purity of the IG production process as our FDA-approved production process. Upon approval of this manufacturing change, ADMA anticipates it will be in a position to produce double the peak forecasted quantity of BIVIGAM using the same equipment, single-use disposables and same labor force. The Vanrx SA25 Workcell has been installed by many leading biologics and vaccine producers in the U.S. and has been FDA approved numerous times. Once installed, the SA25 Workcell will have the capability of rapidly switching between different container and closure formats enabling aseptic filling in a variety of different fill volumes and presentation sizes. Before the BIVIGAM production scale increase and filling machine can be fully implemented for commercial manufacturing, ADMA must submit an amendment to its Biologics License Application to the FDA. ADMA anticipates submitting applications to the FDA for the increased production scale conformance batches of BIVIGAM and the Vanrx filling machine during the second half of 2020. Both the increased production scale and filling machine initiatives and investments are anticipated to be fully operational and contribute to product supply during 2021.
ADMA Biologics price target lowered to $7 from $14 at Oppenheimer » 08:4905/0705/07/20
Oppenheimer analyst Leland Gershell lowered the firm's price target on ADMA Biologics to $7 from $14 as he awaits better visibility on its sales trajectory. The analyst keeps an Outperform rating on the shares.
ADMA Biologics reports Q1 EPS (26c), consensus (12c) » 16:4205/0605/06/20
Reports Q1 revenue…
Reports Q1 revenue $10.2M, consensus $10.88M. "During the first quarter of 2020, we invested in our supply-chain robustness strategy and continued to make progress with reinforcing and expanding our commercial infrastructure by building out our salesforce and medical affairs teams, while generating encouraging year-over-year quarterly revenue growth," said Adam Grossman, ADMA's president and CEO. "I am extremely proud of the ADMA Biologics team as they have risen to the challenge of navigating the Company through the COVID-19 pandemic while continuing to provide critical immune globulin (IG) and hyperimmune globulin products that U.S. patients and physicians need. Due to our strong foundation, we believe we are well-positioned to not only weather the current macroeconomic challenges, but to continue to execute on our future growth plans. Most importantly, everyone at ADMA offers our immense gratitude to all of the healthcare personnel, first responders and others working on the front lines during this pandemic."