Last Updated on January 16, 2019 by Sultan Beardsley
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Adma Biologics (Nasdaq: ADMA) announced today filing of supplementary information to the FDA in response to the complete response letter (CRL) issued for the company’s PAS submission for Bivigam. ADMA anticipates acknowledgment of their response by the FDA within 30 days.
We anticipate the CRL will be classified as a type-1 giving the FDA 2-months to respond to ADMA. If approved, ADMA could subsequently move forward with a commercial launch of Bivigam and start penetrating a market projected to reach $17.50 billion by 2025. RI-002 has a good potential for approval as well in April of 2019 and joing ADMA’s IVIG commercial arsenal.
Watchout however for an offering in April after RI-002’s PDUFA date, approved or not. In late 2019 or early 2020 there is a good chance there will be an offering. In the meantime the price should continue to recover and is a good short-term, and long-term move.
MS rates ADMA a buy with a 1-year price target of $7.
Total revenue is expected to rise 12% in 2019. REVLIMID net product revenue is also expected to rise 11%. Considering the numerous ongoing clinical trials (CX) REVLIMID is in, including multiple with Bristol-Myer Squibbs’ Empliciti and Opdivo, future growth potential is huge for REVLIMID in 2020 and beyond. Net product sales for CELG’s other major products are expected to increase 10-22% with growth being the greatest for POMALYST/IMNOVID and OTEZLA, respectfully.
Financial projections for 2020 are forecasted at $19 billion to $20 billion, or in other words an increase between ~12% and ~18% assuming total revenue of $17 billion in 2019. Also in 2020 adjusted diluted EPS is should surpass $12.50 per share “at constant currency using an average of December, 2018 spot rates”.
In consideration of 2018 revenue growth, respectable financial projections for 2019 and 2020, the recent acquisition of 69% of CELG by BMY to form an innovative Biopharma company, aggressive 2019 milestone guidance, and an extensive CX activity for big market indications; we rate CELG a strong buy and assign a $150 twelve month price target.
Guidance For Key Milestones Maximizing Commercial Assets
Milestones Expected For Key Pivotal-Assets
Key Milestones Expected For Research and Early Development Pipeline
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