ADMA Biologics, Inc. (ADMA)
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FOCUS Sul RI-002:
19/DIC/2018: hanno ricevuto da FDA una CRL:
"FDA’s Complete Response Letter (“CRL”), received on Wednesday, December 19th, in response to the Company’s drug substance Prior Approval Supplement (“PAS”) submission and previously approved drug product PAS submission"
entro 02/APR/2019: prevista PDUFA :
"Resubmission of Biologics License Application (“BLA”) Reinforces the Company’s Commitment to Commercialize Novel Therapies for Immune Compromised Patients to Address Unmet Medical Needs"
Intanto 6 nuovi acquisti da insiders:
ADMA | Dividend Bot
Hanno anche "approntato" il sito di produzione:
Andamento tecnico del titolo:
ultimamente si sono visto grossi blocchi in acquisto (non ultimo quello di venerdì scorso)
19/DIC/2018: hanno ricevuto da FDA una CRL:
"FDA’s Complete Response Letter (“CRL”), received on Wednesday, December 19th, in response to the Company’s drug substance Prior Approval Supplement (“PAS”) submission and previously approved drug product PAS submission"
entro 02/APR/2019: prevista PDUFA :
"Resubmission of Biologics License Application (“BLA”) Reinforces the Company’s Commitment to Commercialize Novel Therapies for Immune Compromised Patients to Address Unmet Medical Needs"
Intanto 6 nuovi acquisti da insiders:
ADMA | Dividend Bot
Hanno anche "approntato" il sito di produzione:
Andamento tecnico del titolo:
ultimamente si sono visto grossi blocchi in acquisto (non ultimo quello di venerdì scorso)
Ultimi earnings 13 /marzo /2019:
“As part of our compliance enhancement upgrades to our Boca Raton, FL facility, we optimized the intravenous immunoglobulin (“IVIG”) manufacturing process for BIVIGAM®. We continue to work with the FDA to finalize our BIVIGAM Prior Approval Supplement (“PAS”) for drug substance, with the goal of reintroducing BIVIGAM® to the market this year. We are also working closely with the FDA on the pending application for RI-002’s initial approval, and the FDA action date is scheduled for April 2, 2019,” continued Mr. Grossman.
“Other notable accomplishments include: retiring approximately 8.6 million shares of our non-voting common stock from Biotest Pharmaceuticals Corporation, receiving FDA approval of our plasma collection center in Kennesaw, GA, obtaining FDA approval for the BIVIGAM® drug product PAS and completing a debt refinancing of up to $72.5 million with Perceptive Advisors.”
Mr. Grossman concluded, “We look forward to continuing to work with the FDA during 2019 as we seek FDA approval for the pending applications for both RI-002 and BIVIGAM®. FDA approval for RI-002 and BIVIGAM®, if received, along with Nabi-HB®, our presently commercially available hyperimmune globulin, would give us three commercial immune globulin products and would make ADMA one of the few globally recognized plasma manufacturers offering a portfolio of novel immune globulin products.”
Recent Achievements and Upcoming Milestones
Improved compliance status for the Boca Raton, FL facility to VAI, enabling ADMA to submit regulatory applications for FDA review and potential approval
Obtained FDA approval for our Kennesaw, GA plasma collection center
Completed a debt refinancing of up to $72.5 million with Perceptive Advisors
Ongoing work with the FDA to obtain approval of the BIVIGAM® drug substance PAS in order to relaunch the product
Prescription Drug User Fee Act action date of April 2, 2019 for RI-002
Potential commercial sales of BIVIGAM® and RI-002
Continue to produce, release and market commercial product for Nabi-HB® in the U.S.
Expand promotional activities for Nabi-HB
Financial Results for the Year Ended December 31, 2018
ADMA reported total revenues of $17.0 million for the year ended December 31, 2018, as compared to $22.8 million for the year ended December 31, 2017, representing a decrease of $5.8 million. The decrease in revenues is primarily due to $7.0 million of non-recurring revenue generated in 2017 that was related to an amendment to our contract manufacturing agreement and a decrease in the sale of normal source plasma of $1.6 million in 2018 due to increased competition from other plasma donation centers which have opened in close proximity to the plasma collection centers we transferred to Biotest on January 1, 2019, partially offset by an increase in Nabi-HB revenues of $2.8 million.
The consolidated net loss for the year ended December 31, 2018 was $65.7 million, or $(1.45) per basic and diluted share, as compared to a consolidated net loss of $43.8 million, or $(1.91) per basic and diluted share for the year ended December 31, 2017. The increase in net loss of $22.0 million was primarily attributable to an increase in cost of product revenue from the manufacture of conformance lots production of RI-002 and BIVIGAM®, which can be used for commercial sales upon FDA approval, higher operational expenses reflecting a full year of operations at the Boca Raton, FL facility for 2018, as compared to just seven months of operating activity at the Boca Raton, FL facility in 2017, as well as the initiation of marketing and commercial activities and the decrease in revenues. Included in the net loss for the year ended December 31, 2018 were non-cash expenses of $6.8 million for stock-based compensation, depreciation and amortization, and non-cash interest expense.
At December 31, 2018, ADMA had cash and cash equivalents of $22.8 million, as compared to $43.1 million at December 31, 2017. ADMA’s net working capital was $34.9 million as of December 31, 2018, as compared to $52.9 million as of December 31, 2017.
“As part of our compliance enhancement upgrades to our Boca Raton, FL facility, we optimized the intravenous immunoglobulin (“IVIG”) manufacturing process for BIVIGAM®. We continue to work with the FDA to finalize our BIVIGAM Prior Approval Supplement (“PAS”) for drug substance, with the goal of reintroducing BIVIGAM® to the market this year. We are also working closely with the FDA on the pending application for RI-002’s initial approval, and the FDA action date is scheduled for April 2, 2019,” continued Mr. Grossman.
“Other notable accomplishments include: retiring approximately 8.6 million shares of our non-voting common stock from Biotest Pharmaceuticals Corporation, receiving FDA approval of our plasma collection center in Kennesaw, GA, obtaining FDA approval for the BIVIGAM® drug product PAS and completing a debt refinancing of up to $72.5 million with Perceptive Advisors.”
Mr. Grossman concluded, “We look forward to continuing to work with the FDA during 2019 as we seek FDA approval for the pending applications for both RI-002 and BIVIGAM®. FDA approval for RI-002 and BIVIGAM®, if received, along with Nabi-HB®, our presently commercially available hyperimmune globulin, would give us three commercial immune globulin products and would make ADMA one of the few globally recognized plasma manufacturers offering a portfolio of novel immune globulin products.”
Recent Achievements and Upcoming Milestones
Improved compliance status for the Boca Raton, FL facility to VAI, enabling ADMA to submit regulatory applications for FDA review and potential approval
Obtained FDA approval for our Kennesaw, GA plasma collection center
Completed a debt refinancing of up to $72.5 million with Perceptive Advisors
Ongoing work with the FDA to obtain approval of the BIVIGAM® drug substance PAS in order to relaunch the product
Prescription Drug User Fee Act action date of April 2, 2019 for RI-002
Potential commercial sales of BIVIGAM® and RI-002
Continue to produce, release and market commercial product for Nabi-HB® in the U.S.
Expand promotional activities for Nabi-HB
Financial Results for the Year Ended December 31, 2018
ADMA reported total revenues of $17.0 million for the year ended December 31, 2018, as compared to $22.8 million for the year ended December 31, 2017, representing a decrease of $5.8 million. The decrease in revenues is primarily due to $7.0 million of non-recurring revenue generated in 2017 that was related to an amendment to our contract manufacturing agreement and a decrease in the sale of normal source plasma of $1.6 million in 2018 due to increased competition from other plasma donation centers which have opened in close proximity to the plasma collection centers we transferred to Biotest on January 1, 2019, partially offset by an increase in Nabi-HB revenues of $2.8 million.
The consolidated net loss for the year ended December 31, 2018 was $65.7 million, or $(1.45) per basic and diluted share, as compared to a consolidated net loss of $43.8 million, or $(1.91) per basic and diluted share for the year ended December 31, 2017. The increase in net loss of $22.0 million was primarily attributable to an increase in cost of product revenue from the manufacture of conformance lots production of RI-002 and BIVIGAM®, which can be used for commercial sales upon FDA approval, higher operational expenses reflecting a full year of operations at the Boca Raton, FL facility for 2018, as compared to just seven months of operating activity at the Boca Raton, FL facility in 2017, as well as the initiation of marketing and commercial activities and the decrease in revenues. Included in the net loss for the year ended December 31, 2018 were non-cash expenses of $6.8 million for stock-based compensation, depreciation and amortization, and non-cash interest expense.
At December 31, 2018, ADMA had cash and cash equivalents of $22.8 million, as compared to $43.1 million at December 31, 2017. ADMA’s net working capital was $34.9 million as of December 31, 2018, as compared to $52.9 million as of December 31, 2017.
Ultima modifica:
domani ADMA partecip ad una conferenza per investitori
As previously disclosed, Adam Grossman, the President and Chief Executive Officer of ADMA Biologics, Inc., a Delaware corporation (the “Company”), and Brian Lenz, the Company’s Executive Vice President and Chief Financial Officer, plan to present at Oppenheimer’s 29th Annual Healthcare Conference in New York, NY, on Tuesday, March 19, 2019 at 8:35 AM ET (the “Investor Presentation”)
ADMA / ADMA Biologics Inc - Stock Price Quote and News - Fintel.io
As previously disclosed, Adam Grossman, the President and Chief Executive Officer of ADMA Biologics, Inc., a Delaware corporation (the “Company”), and Brian Lenz, the Company’s Executive Vice President and Chief Financial Officer, plan to present at Oppenheimer’s 29th Annual Healthcare Conference in New York, NY, on Tuesday, March 19, 2019 at 8:35 AM ET (the “Investor Presentation”)
ADMA / ADMA Biologics Inc - Stock Price Quote and News - Fintel.io
ADMA Biologics, Inc. (ADMA)
NasdaqCM - NasdaqCM Real Time Price. Currency in USD
4.2400+0.2500 (+7.27%)
At close: March 18 4:00PM EDT
Conto di uscire prima della PDUFA (magari ne tengo una manciata solo per "curiosità" di vedere che succede...), a 4,5$ dovrebbe arrivare.
Poi volendo "sognare" una 3° onda, potrebbe spuntarla fino a 5,4-5,5$
In after: 4,35$ (con un paio di migliaia di pz)
NasdaqCM - NasdaqCM Real Time Price. Currency in USD
4.2400+0.2500 (+7.27%)
At close: March 18 4:00PM EDT
Conto di uscire prima della PDUFA (magari ne tengo una manciata solo per "curiosità" di vedere che succede...), a 4,5$ dovrebbe arrivare.
Poi volendo "sognare" una 3° onda, potrebbe spuntarla fino a 5,4-5,5$
In after: 4,35$ (con un paio di migliaia di pz)
Pablo.Escobar
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Ci provo dentro 1,56
Pablo.Escobar
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Sbagliato 3d
...come presunto si è appoggiata alla trend line e non l'ha bucata al ribasso.
Buono il recupero della quotazione nel finale di giornata.
Scommessa "ponderata"...da qui al 2 Aprile
scusa ma lo stop?
era sulla trend line ..3,15$ "circa" va meglio? il minimo è stato 3,10$ e poi ha recuperato ed avendole io in carico a 4$ già da prima , le ho tenute e me le "gioco" . Dopo ho segnalato il trend che restava positivo fino a 3,15
meglissimo , sperem
l' allievo
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ciao a tutti......$ADMA CHE Tp.....vi ponete? uscite prima dei dati del 2 Aprile??? sfruttando un eventuale runn??
Ultima modifica:
gli scenari (IMO) quando si tratta di responso FDA in un dato giorno [X] :
1) accumulare fino alla data [X-1] e vendere prima del responso sull'onda della possibile speculazione
2) accumulare fino alla data [X] e sfruttare l'apertura col botto per vendere subito
3) come il punto 2, e poi ricomprare dopo le prese di profitto
4) botta di ciapettt, e il titolo raddoppia di valore
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1) accumulare fino alla data [X-1] e vendere prima del responso sull'onda della possibile speculazione
2) accumulare fino alla data [X] e sfruttare l'apertura col botto per vendere subito
3) come il punto 2, e poi ricomprare dopo le prese di profitto
4) botta di ciapettt, e il titolo raddoppia di valore
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