Lantheus Holdings, Inc. (LNTH) SEC Filings & Earnings Calls

FTC second request may delay or block merger; closing expected first half 2027 but subject to regulatory approval.

“The effect of a Second Request is to extend the waiting period imposed by the HSR Act, until 30 days after the Company and Parent each have substantially complied with the Second Request issued to it, unless that period is terminated sooner by the FTC.” · word for word

Merger could be delayed or enjoined if court finds disclosures inadequate; additional legal costs.

“The Complaints assert claims under state common law and seek, among other things, to enjoin consummation of the Merger unless and until certain additional information is disclosed.” · word for word

Activist/strategic holder reducing stake

“Lantheus Alpha sold 2,701,502 shares in open market transactions over several days in September 2026, reducing its beneficial ownership to 7.7%.”

Antitrust review delay; potential for extended review or request for additional information.

“Voluntary withdrawal and refiling of HSR notification; FTC may issue request for additional information.”

Preclinical asset risk

“The June 2024 Purchase involved two licensed preclinical assets, which are early-stage and subject to clinical and regulatory risks.”

Dilution risk

“The filing reports dilution of beneficial ownership since the original statement, indicating the issuer issued additional shares.”

Preclinical asset risk

“The June 2024 Purchase involved two licensed preclinical assets, which are early-stage and subject to clinical and regulatory risks.”

Dilution risk

“The filing reports dilution of beneficial ownership since the original statement, indicating the issuer issued additional shares.”

Pending acquisition creates execution risk; guidance suspended; PYLARIFY sales declining.

“Guidance suspended due to pending transaction; PYLARIFY sales decreased 4.1% YoY.”

LNTH-2501 approval delay

“On June 26, 2026, we announced that the FDA issued a Complete Response Letter (“CRL”) regarding the NDA, stating that the agency could not approve the NDA by the June 29, 2026 extended PDUFA target action date due to unresolved third-party facility manufacturing-related conditions.” · word for word

Merger completion risk

“The transaction is currently expected to close in the first half of 2027, subject to satisfaction of customary closing conditions, including receipt of our shareholders’ approval and regulatory approvals.” · word for word

Transaction subject to shareholder approval, regulatory clearance, and other closing conditions.

“Merger subject to terms and conditions set forth in the Merger Agreement.”

Transaction subject to stockholder approval, regulatory approvals, and other conditions; may not close on expected timeline or at all.

“The Spin Transaction is subject to customary conditions, including final approval by Liberty Global’s board of directors, the SEC declaring effective a registration statement, approval by Liberty Global’s shareholders”

CVR milestone achievement uncertain; holders may not receive payments.

“uncertainty as to whether the Milestones associated with the contingent value rights (CVRs) will be achieved and that holders of CVRs will receive payments in respect thereof”

PYLARIFY revenue decline (-6.5%) may indicate competitive pressure or market saturation in PSMA PET imaging.

“Sales of PYLARIFY were $240.9 million, a decrease of 6.5%.” · word for word

Adjusted EPS decline (-4.6%) despite GAAP EPS growth suggests non-recurring items or cost pressures.

“Adjusted fully diluted earnings per share decreased 4.6% to $1.46.”

Reimbursement Risk for PYLARIFY

“Since January 1, 2025, CMS has maintained separate payment for PYLARIFY based on MUC in the hospital outpatient setting, which is lower than payments based on the average selling price that were made during TPT Status.” · word for word

Competitive Pressure in PSMA PET

“PYLARIFY’s competition includes three Ga-68-based PSMA imaging agents, an F-18-based PSMA imaging agent, and other non-PSMA-based imaging agents... The potential for future generic entrants following the expiration of PYLARIFY’s new chemical entity exclusivity period in 2026 could further increase competition.” · word for word

Regulatory and Commercialization Risk for New Products

“PYLARIFY TruVu is expected to become commercially available beginning in the fourth quarter of 2026 and will be introduced on a rolling geographic basis... The timing of our launch will consider the following factors: the timing of final FDA approval, the expiration of the 30-month Hatch-Waxman stay and disposition of the related legal proceedings.” · word for word

Potential shareholder dilution from increased equity plan shares.

“Increase in shares reserved for issuance under equity plan.”

PYLARIFY competitive headwinds

“Company did not meet financial goals due in part to competitive headwinds with PYLARIFY.” · word for word

Below-target financial performance

“Net Revenue target $1,694M, actual $1,536M (69% payout); Bonus EPS target $6.14, actual $5.14 (0% payout)”

Equity dilution from increased share reserve

“Overhang would increase from 7.57% to 10.65% if additional 2,000,000 shares approved.”

CMS Reimbursement Disadvantage

“Effective January 1, 2025, CMS began maintaining separate payment for PYLARIFY based on MUC in the hospital outpatient setting, which is lower than payments based on ASP that were made during TPT Status.” · word for word

Competitive Reimbursement Gap for Neuraceq

“Neuraceq is paid based on its MUC, however, other competitive imaging agents are currently being paid based on a higher MUC rate.” · word for word

IRA Drug Pricing Negotiation Risk

“Although the IRA provides for a limited number of categorical exclusions from Medicare negotiation, radiopharmaceuticals are not among those categorical exclusions.” · word for word

Leadership transition risk; no permanent successor announced.

“CEO retirement without named successor; consulting period limited to 3 months.”

Leadership transition: CEO and President both departing; potential execution risk during search.

“CEO retiring Dec 31, 2025; President leaving Nov 7, 2025; Board conducting CEO search.”

GAAP net income sharply down due to acquisition-related costs; adjusted metrics provide cleaner view.

“GAAP net income $27.8M (-78.8%); adjusted EPS $1.27.”

Acquisition integration risk for Life Molecular Imaging.

“Closed acquisition of Life Molecular Imaging in July.” · word for word

PSMA PET Reimbursement Disadvantage

“Effective January 1, 2025, CMS began maintaining separate payment for PYLARIFY based on MUC in the hospital outpatient setting, which is lower than payments based on the average selling price that were made during TPT Status.” · word for word

Leadership Transition Uncertainty

“Brian Markison, our Chief Executive Officer, notified us that he will retire from the Company effective December 31, 2025.”

Generic Competition Risk

“The potential for future generic entrants to the market due to the expiry of PYLARIFY’s new chemical entity exclusivity period in 2026 could also generate increased competition for PYLARIFY.” · word for word