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Imaging Diagnostics Co.'s Shares Rise 35% on FY21 Earnings
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Lantheus Holdings Inc. shares traded to a new 52-week high after the firm reported Q4/21 and FY/21 financial results that included a 25.3% increase in annual revenue. The firm also advised that the FDA approved the sNDA for its isolator-based drug manufacturing facility for diagnostic ultrasound enhancing agent DEFINITY® for patients in the U.S. with suboptimal echocardiograms.

Imaging diagnostics, targeted therapeutics and AI solutions company Lantheus Holdings Inc (LNTH:NASD), today announced financial results for the fourth quarter and full year of 2021 ended December 31, 2021.

The company indicated that worldwide revenue in Q4/21 increased by 37.6% to $129.6 million, compared to $94.2 million in Q4/20 and added that FY/21 worldwide revenues rose by 25.3% to $425.2 million, compared to $339.4 million during FY/20.

Lantheus Holdings advised that it posted a GAAP net loss in Q4/21 of $40.2 million, or $0.59 per fully diluted share, versus a GAAP net loss of $3.4 million, or $0.05 per share in Q4/20. For FY/21, the firm recorded a net loss of $71.3 million, or $1.06 per fully diluted share, compared to net loss of $13.5 million, or $0.25 per share in FY/20.

Lantheus Holdings' President and CEO Mary Anne Heino commented, "Lantheus delivered another strong quarter and full year, highlighted by revenue performance which increased 38% and 25%, respectively…We successfully launched PYLARIFY, which we believe is the best-in-class PSMA PET imaging agent for prostate cancer, maintained our revenue growth and market leadership for DEFINITY, and delivered top quartile returns for our shareholders, even amidst a backdrop of macro external challenges."

"This year is off to a similarly productive start as we received FDA approval for our on-site manufacturing facility for DEFINITY," Heino added.

The company provided some forward guidance and advised that for Q1/22 it expects revenues of $160-170 million and adjusted fully diluted earnings of $0.45-0.50 per share.

Lantheus added that for FY/22 it estimates revenues of $685-710 million and adjusted fully diluted earnings of $1.95-2.05 per share.

In a separate news release yesterday, the company announced that "the U.S. Food and Drug Administration (FDA) has approved the Supplemental Drug Application (sNDA) for the company's isolator-based drug manufacturing facility for DEFINITY® (Perflutren Lipid Microsphere), the leading diagnostic ultrasound enhancing agent in U.S. for patients with suboptimal echocardiograms."

The firm noted that together with its partners, it built a specialized 16,000 sq. ft. state-of-the-art manufacturing facility at its North Billerica, Mass. headquarters with the primary purpose of producing DEFINITY and other potential sterile vial products.

CEO Heino remarked, "Achieving approval of our on-site manufacturing facility was a company-wide effort and represents an important step forward for Lantheus' strategy to improve the security of DEFINITY supply…This facility will provide the company with supply chain redundancy and the opportunity for margin expansion as we progressively include DEFINITY inventory from this facility into our supply chain. We intend to begin shipping DEFINITY from our on-site manufacturing facility to customers immediately."

The company explained that "DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension (activated) is an ultrasound enhancing agent for use in patients with suboptimal echocardiograms." The firm indicated that "DEFINITY is engineered to produce small and consistently sized durable microbubbles to fully evaluate the left ventricle," and since its initial launch in 2001, has been used in greater than 18 million echo studies.

Lantheus Holdings is a global developer, manufacturer and marketer of diagnostic and therapeutic agents and products engineered to identify disease and improve patient treatment and care. The firm listed that it is the parent company of Lantheus Medical Imaging Inc., Progenics Pharmaceuticals Inc. and EXINI Diagnostics AB. The firm is based in North Billerica, Mass. and has other offices in New Jersey, Canada, and Sweden, employing over 600 people worldwide.

The Lantheus portfolio of companies is focused on providing fully integrated and innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to address serious medical conditions. Lantheus product portfolio includes echocardiography agent DEFINITY® Vial for Injectable Suspension; PSMA PET imaging agent PYLARIFY® for the detection of prostate cancer; an AI platform PYLARIFY AI™ to evaluate PSMA PET images; technetium-based generator TechneLite® used in nuclear medicine procedures. In addition, the company's AZEDRA® was developed to treat rare neuroendocrine tumors and it partners with Bausch Health on RELISTOR® in treatment of opioid-induced constipation.

Lantheus began the day with a market cap of around $2.0 billion with approximately 67.69 million shares outstanding and a short interest of about 2.6%. LNTH shares opened more than 30% higher today at $38.28 (+$9.42, +32.64%) over yesterday's $28.86 closing price and reached a new 52-week high price this morning of $41.51. The stock has traded today between $37.79 and $41.51 per share and is currently trading at $39.33 (+$10.47, +36.28%).


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