Medivir Raises SEK 130 Million to Advance MIV-711 as First Pharmacological Treatment for Pediatric Perthes Disease
核心洞察
Medivir AB completed an oversubscribed directed share issue raising approximately SEK 130 million, with existing shareholders committing SEK 70 million.
Proceeds will primarily fund a proof-of-concept clinical trial for MIV-711 in Legg-Calvé-Perthes disease (搜索), a rare pediatric condition with no approved drug treatment.
MIV-711 has received both FDA Orphan Drug Designation and Rare Pediatric Disease Designation, potentially qualifying for a Priority Review Voucher upon approval.
Medivir AB has successfully completed an oversubscribed directed share issue, raising approximately SEK 130 million to fund the clinical development of its drug candidate MIV-711 for a new orphan indication: Legg-Calvé-Perthes disease (搜索) (Perthes), a rare pediatric condition for which no approved pharmacological treatment currently exists.
The capital raise, conducted through an accelerated bookbuilding process led by DNB Carnegie Investment Bank AB (搜索) as Sole Global Coordinator and Bookrunner, attracted both new and existing institutional investors. Existing shareholders Hallberg Management AB, Carl Bennet AB, LINC AB, and Nordea Småbolagsfond Norden announced their intention to subscribe for shares totaling SEK 70 million, underscoring strong insider confidence in the company's strategy.
Addressing an Unmet Medical Need in Pediatric Orthopedics
Legg-Calvé-Perthes disease (搜索) is a rare condition in which the femoral head degenerates in children. Current treatment options—orthoses and surgery—do not address the underlying disease process and yield insufficient results. Without an effective pharmacological intervention, affected children face the risk of permanent joint deformity, severe osteoarthritis, chronic pain, and lifelong functional impairment.
"MIV-711 has the potential to become the first approved drug for Perthes disease," Medivir stated in its announcement, citing the drug candidate's established clinical safety profile and strong scientific evidence for slowing the breakdown of cartilage and bone—mechanisms central to the disease process.
Regulatory Designations and Commercial Potential
MIV-711 has already been granted Orphan Drug Designation by the U.S. Food and Drug Administration for Perthes disease, providing important benefits including seven years of market exclusivity in the U.S. following approval, regulatory support, and reduced development costs. The candidate has also received Rare Pediatric Disease Designation, confirming the severity of the condition and the significant unmet medical need. Upon future market approval in the U.S., MIV-711 may additionally qualify for a Priority Review Voucher.
Medivir estimates that MIV-711 for Perthes disease, upon future market approval in Europe and the U.S., has the potential to generate peak annual sales of approximately SEK 9.4 billion five years after launch. The company's risk-adjusted valuation for the project is estimated at approximately SEK 1.0 billion, an assessment reviewed by independent analysis firm Xplico.
Allocation of Proceeds
The company intends to deploy the net proceeds from the directed share issue across three primary areas. Approximately 65% will fund a randomized proof-of-concept clinical trial in children with Perthes disease. An additional 20% is earmarked for pediatric formulation development and drug manufacturing, including the creation of a pediatric-adapted oral formulation suitable for daily dosing in children. The remaining 15% will support dedicated team resources in clinical operations, regulatory affairs, and project management.
Rationale for the Directed Share Issue Structure
Medivir's board of directors conducted a comprehensive assessment and determined that a directed share issue was preferable to a rights issue, citing the significantly longer execution timeline and higher costs typically associated with rights offerings. The board also noted challenging capital market conditions for research companies and the risk that a rights issue conducted at a significant discount could negatively impact the share price. The directed share issue structure additionally provides an opportunity to diversify and strengthen the company's shareholder base with institutional investors.
Following the transaction, Medivir reports a total of 626,487,237 shares outstanding, comprising 624,037,074 ordinary shares and 2,450,163 class C shares, corresponding to 624,282,090.3 votes. The company has undertaken a 90-day lock-up period from the settlement date, during which no additional shares will be issued, and key shareholders, board members, and senior executives have agreed to corresponding lock-up commitments.