CALT - Calliditas: Underfollowed Swedish Biotech Focusing On Rare Kidney Disease

Summary

• Calliditas Therapeutics is a commercial-stage biopharmaceutical company based in Sweden focused on developing and commercializing novel treatments for rare diseases.
• TARPEYO is the only disease-modifying therapy approved for IgAN.
• We expect TARPEYO's 2023 sales to be better than what the market expects, exceeding $120m.
• We initiate with a buy rating.

Background

Calliditas Therapeutics ( CALT ) is a Sweden-based commercial-stage biopharmaceutical company that specializes in developing and commercializing innovative treatments for rare diseases. The company's flagship product, TARPEYO (Nefecon), has received FDA and EMA approval for the treatment of IgA nephropathy (IgAN), a chronic autoimmune renal disease that can lead to end-stage renal disease. In 2022, TARPEYO achieved net sales of SEK229.3m (USD 21.8m), primarily from the US, where Calliditas is marketing the product in-house. Additionally, TARPEYO has secured a strategic partnership with EVEREST Medicine, a leading Chinese pharmaceutical company, and has received acceptance by the NMPA (Chinese FDA). In Japan, Viatris Pharmaceutical is marketing the product, and a mid-teens percentage royalty is expected to be paid to Calliditas. In February 2023, the MHRA granted conditional marketing authorization or CMA , and STADA is expected to market the product in the Swiss and UK markets. Calliditas Therapeutics has projected sales of USD 120-150m for 2023, further indicating the significant commercial potential of TARPEYO in treating IgAN.

TARPEYO, Nefecon is differentiated targeted budesonide targeting IgAN patients

TARPEYO is a lead commercial candidate of Calliditas Therapeutics.

TARPEYO is approved under accelerated approval based on achieving its primary endpoint of reduction in proteinuria in Part A of the NeflgArd pivotal Phase 3 study, an ongoing, randomized, double-blind, placebo-controlled, multicenter study conducted to evaluate the efficacy and safety of TARPEYO 16 mg once daily vs placebo in adult patients with primary IgAN.1 The effect of TARPEYO was assessed in patients with biopsy-proven IgAN, eGFR ?35 mL/min/1.73 m2, and proteinuria (defined as either ?1 g/day or UPCR ?0.8 g/g) who were on a stable dose of maximally-tolerated RAS inhibitor therapy.

Patients taking TARPEYO (n=97) showed a statistically significant 34% reduction in proteinuria from baseline vs 5% with RASi alone (n=102) at 9 months. The treatment effects for the primary endpoint of UPCR at 9 months were consistent across key subgroups, including key demographic and baseline disease characteristics.1

The most common adverse reactions (?5%) in this study were hypertension, peripheral edema, muscle spasms, acne, dermatitis, weight increase, dyspnea, face edema, dyspepsia, fatigue, and hirsutism. Source: News Release

Overall, TARPEYO was well-tolerated in the study.

Risks

For further details see: