RECORDATI: STRONG MOMENTUM OF THE GROUP CONTINUES INTO THE FIRST QUARTER OF 2026 NET REVENUE +4.9%, EBITDA(1) +5.0%, ADJUSTED NET INCOME(2) +7.2%

Recordati Reports Strong Q1 2026 Financials and Pipeline Progress

Recordati reported strong financial results for the first quarter of 2026, with consolidated net revenue reaching €713.4 million, a 4.9% increase (+8.7% like-for-like at constant exchange rates). EBITDA grew by 5.0% to €283.6 million, and adjusted net income rose by 7.2% to €188.1 million. The company also announced significant pipeline advancements, including positive Phase 2 results for pasireotide in post-bariatric hypoglycemia, leading to a scheduled FDA meeting. Additionally, sutimlimab is set to advance into a pivotal Phase 3 trial for chronic immune thrombocytopenia, and the collaboration with Moderna for mRNA-3927 in propionic acidemia is progressing with data expected by year-end. Recordati confirmed its full-year 2026 financial targets.

• Robust Financial Performance in Q1 2026: Recordati demonstrated strong financial growth in the first quarter of 2026, with consolidated net revenue increasing by 4.9% to €713.4 million. This performance was further underscored by an 8.7% like-for-like growth at constant exchange rates, primarily driven by the Rare Diseases business. EBITDA also saw a healthy rise of 5.0% to €283.6 million, contributing to a 39.7% margin on net revenue, while adjusted net income climbed 7.2% to €188.1 million.
• Positive Phase 2 Results for Pasireotide in PBH: The Phase 2 trial evaluating pasireotide for post-bariatric hypoglycemia (PBH) successfully met its primary endpoint. The study demonstrated a dose-dependent and statistically significant increase in glucose levels during a standardized meal test (p<0.02). These positive results have prompted Recordati to schedule a meeting with the FDA to discuss the potential next steps for the development of pasireotide in this indication.
• Sutimlimab Advances to Pivotal Phase 3 for Chronic ITP: Following encouraging feedback from the FDA and promising early clinical evidence, Recordati is progressing sutimlimab into a pivotal registrational Phase 3 trial for the treatment of chronic immune thrombocytopenia (ITP). Sutimlimab, which targets the classical complement pathway, has shown potential for rapid and sustained platelet response in patients refractory to multiple lines of treatment, addressing a significant unmet need in this rare autoimmune disease.
• Strategic Collaboration with Moderna for mRNA-3927: Recordati's collaboration with Moderna for mRNA-3927, an investigational product for propionic acidemia (PA), is advancing well. The target patient enrollment for the potential registrational clinical study has been achieved, with a data readout anticipated by the end of 2026. If approved, mRNA-3927, designed to restore propionyl-CoA carboxylase enzyme activity, could represent the first disease-modifying treatment option for this severe rare disease.

Addressing the Unmet Needs in Post-Bariatric Hypoglycemia

Post-bariatric hypoglycemia (PBH) represents a significant and under-recognized complication affecting approximately 30% of patients following bariatric surgery, particularly Roux-en-Y gastric bypass. Recent research has identified critical gaps in both diagnostic approaches and therapeutic interventions, driving efforts to develop more effective management strategies for this challenging condition.

• Limited therapeutic arsenal: Current treatment options remain insufficient, with most interventions focusing on dietary modifications and expensive somatostatin analogues that carry significant side effects, creating an urgent need for novel therapeutic approaches

• Inadequate preventive strategies: CGM-guided forecasting algorithms show promise but require optimization, as current 5g preventive glucose doses prove insufficient, though simulations suggest 10g doses could reduce hypoglycemia incidence to 9%

• Diagnostic and monitoring gaps: Under-diagnosis remains prevalent due to limited recognition in clinical practice, with CGM technology emerging as a critical tool to fill the diagnostic void and provide comprehensive 24-hour glycemic assessment

• Need for standardized definitions and outcome measures: The field lacks consistent PBH definitions, patient-centered outcome measures, and adequately powered randomized controlled trials to establish evidence-based therapeutic guidelines

• Female predominance requiring targeted approaches: Women represent 92-100% of PBH cohorts with significantly increased risk (OR: 1.91), necessitating gender-specific management strategies and research focus

• RYGB patients as high-risk population: Roux-en-Y gastric bypass patients face elevated PBH risk (OR: 1.81) compared to sleeve gastrectomy, requiring specialized monitoring protocols and preventive interventions for this surgical population

• Long-term post-surgical complications: Patients more than a decade post-surgery (studied at 14.5 years post-RYGB) represent an understudied population requiring sustained monitoring and management approaches

• Comorbidity management gaps: High rates of IBS, dumping symptoms, and autonomic dysfunction in PBH patients suggest need for comprehensive care addressing underlying pathophysiological mechanisms beyond glucose management alone

Pasireotide's Broader Pipeline: Beyond Post-Bariatric Hypoglycemia

Pasireotide's clinical development extends across multiple endocrine and metabolic disorders, with the most robust evidence emerging from acromegaly and Cushing's disease programs. The drug demonstrates particular promise in conditions where conventional somatostatin analogues show limited efficacy, though hyperglycemia remains a consistent safety consideration across all indications.

Pasireotide's Advance: Charting a New Course for Post-Bariatric Hypoglycemia

Recordati's announcement of positive Phase 2 results for pasireotide in post-bariatric hypoglycemia (PBH) and the subsequent scheduling of an FDA meeting signals a promising step forward for patients grappling with this challenging condition. PBH, a complex sequela of bariatric surgery, is characterized by severe hypoglycemia and significantly impacts quality of life for a growing population. The current therapeutic landscape for PBH is fragmented, often relying on dietary modifications, off-label use of various agents, or, in refractory cases, first-generation somatostatin analogues.

Pasireotide, a second-generation somatostatin analogue with a broader affinity for multiple somatostatin receptors (SSTR1, 2, 3, and 5), offers a differentiated approach to modulating hormone secretion, which is critical in managing hyperinsulinism. This broader receptor engagement could provide a more robust therapeutic effect compared to older analogues that primarily target SSTR2 and SSTR5. If successful in pivotal trials, pasireotide could establish a new standard of care, expanding its market presence beyond its current indications in Cushing's disease and acromegaly, and solidifying Recordati's position in specialty endocrinology.

However, the path forward is not without its complexities. A primary concern is pasireotide's well-established side effect profile, notably the induction of hyperglycemia and diabetes mellitus. This presents a unique challenge for a drug designed to treat hypoglycemia, necessitating rigorous patient selection and management strategies to balance efficacy with metabolic control. Furthermore, while the Phase 2 data are encouraging, previous studies on pasireotide in PBH have been limited by small sample sizes and heterogeneous definitions, underscoring the critical need for robust, well-designed Phase 3 trials to confirm consistent efficacy and safety. The high cost associated with somatostatin analogues also remains a consideration for market access and long-term patient adherence. As Recordati moves towards a pivotal Phase 3, the industry will be closely watching how these challenges are addressed, potentially reshaping the treatment paradigm for PBH.