Calliditas Therapeutics AB

Calliditas Therapeutics AB clinical-stage biopharmaceutical company. It engages in the identification, development, and commercialization of novel treatments in orphan indications. The firm focuses on renal and hepatic diseases with significant unmet medical needs. It offers Nefecon, a proprietary, novel oral formulation of budesonide for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN. The firm product TARPEYO is used to reduce proteinuria in adults with primary immunoglobulin. The company was founded by Mikael Bender and Bengt Åke Julander on February 20, 2004 and is headquartered in Stockholm, Sweden.

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Calliditas Therapeutics AB is a specialty pharmaceutical company based in Stockholm, Sweden. It is focused on developing high quality pharmaceutical products for patients with a significant unmet medical need in niche indications, in which Calliditas can partially or completely participate in the commercialization efforts. Calliditas is focused on the development and commercialization of the product candidate Nefecon, a unique two step formulation optimized to combine a time lag effect with a concentrated release of the active substance budesonide, within a designated target area. This patented, locally acting formulation is intended for treatment of patients with the inflammatory renal disease IgA nephropathy (IgAN). Calliditas is running a global Phase 3 study within IgAN and aims to commercialize Nefecon in the United States.

STOCKHOLM , Aug. 18, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT), (Nasdaq Stockholm: CALTX) ("Calliditas"), today announced that the U.S. Food and Drug Administration (FDA) has accepted the submission for the supplemental New Drug Application (sNDA) for TARPEYO® (budesonide) delayed release capsules and granted Priority Review. The Prescription Drug User Fee Act (PDUFA) goal date is 20 December 2023.

FDA grants priority review for full approval of TARPEYO for the treatment of IgA Nephropathy

Filing for full approval of TARPEYO STOCKHOLM , Aug. 17, 2023 /PRNewswire/ -- FINANCIAL SUMMARY FOR THE GROUP Key Figures April 1 - June 30, 2023 Net sales amounted to SEK 269.4 million, of which TARPEYO® net sales amounted to SEK 259.2 million, for the three months ended June 30, 2023. For the three months ended June 30, 2022, net sales amounted to SEK 64.0 million, of which TARPEYO net sales amounted to SEK 63.6 million.

Interim Report Q2, 2023: Calliditas Therapeutics

STOCKHOLM , Aug. 15, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced publication in The Lancet  of the full data from the Phase 3 NefIgArd Study with Nefecon® (TARPEYO® (budesonide) delayed release capsules/Kinpeygo®) in adults with Primary IgA nephropathy (IgAN). The Phase 3 trial met the primary endpoint, estimated glomerular filtration rate (eGFR), with Nefecon demonstrating significant kidney protective effect over placebo.

Calliditas Therapeutics announces full results from the NefIgArd Phase 3 trial published in The Lancet

We maintain a buy rating due to promising interim data from the Phase II trial of setanaxib in patients with squamous cell carcinoma of the head and neck and potential Q2 earnings from Tarpeyo's sales. Despite promising interim data, the market has yet to appreciate the potential of setanaxib, which could impact the company's short-term stock performance. The company's cash holdings are robust. Calliditas is investing heavily in the Tarpeyo launch; we believe the Tarpeyo sales could hit consensus estimate of ~$120m in 2023.

Calliditas: Riding The Setanaxib Wave And Betting On Tarpeyo's Triumph

STOCKHOLM , July 13, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT) (NASDAQ Stockholm: CALTX) ("Calliditas") today announced interim data from the proof-of-concept Phase 2 trial in patients with squamous cell carcinoma of the head and neck (SCCHN) with its lead NOX 1 and 4 inhibitor product candidate, setanaxib.  The analysis reflects encouraging early clinical progression-free survival (PFS) results and is supportive of the presumed anti fibrotic mode of action of setanaxib.

Calliditas announces supportive interim data from Phase 2 head and neck cancer trial with lead NOX inhibitor candidate, setanaxib

Calliditas Therapeutics AB Sponsored ADR (CALT) saw its shares surge in the last session with trading volume being higher than average. The latest trend in earnings estimate revisions may not translate into further price increase in the near term.

Calliditas Therapeutics AB Sponsored ADR (CALT) Moves 12.8% Higher: Will This Strength Last?

STOCKHOLM , June 21, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced the submission of a supplemental New Drug Application ("sNDA") to the U.S. Food and Drug Administration ("FDA") seeking full approval of TARPEYO® (budesonide) delayed release capsules for the entire study population from the Phase 3 NeflgArd study. TARPEYO is currently approved under accelerated approval to reduce proteinuria in adults with primary IgA nephropathy ("IgAN") at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥1.5g/g.

Calliditas Therapeutics Submits Supplemental New Drug Application to U.S. Food and Drug Administration for Full Approval of TARPEYO®

SHANGHAI , June 20, 2023 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company") announced today that its partner Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") made presentations on data from the NeflgArd Phase 3 Study at the European Renal Association – European Dialysis and Transplant Association Congress (ERA-EDTA), which was held in Milan, Italy, June 15-18. The presentations showed data and analyses from the NefIgArd Phase 3 clinical trial evaluating Nefecon in patients with IgA nephropathy (IgAN).

Everest Medicines' Partner Calliditas Therapeutics Makes Data Presentations on Nefecon at European Renal Association - European Dialysis and Transplant Association Congress (ERA-EDTA )

Shares of Calliditas Therapeutics plunged after the company missed Q1 revenue estimates. The quarter was better than it looks and the company saw record new patient enrollments for Tarpeyo. It was also too early for the recently reported 2-year eGFR data to have a positive impact on prescriptions or net sales.

Calliditas Therapeutics: First Quarter Not As Bad As It Looks

STOCKHOLM , May 16, 2023 /PRNewswire/ --  Strong eGFR Data from Positive NefIgArd Phase 3 Trial Readout "In March we announced that the global NefIgArd Phase 3 trial successfully met its primary endpoint, estimated glomerular filtration rate (eGFR), with a p value < 0.0001. Achieving this clinically relevant endpoint of kidney filtration capability represents a crowning achievement after well over a decade of pioneering work in IgA nephropathy.

Calliditas Therapeutics: Interim Report Q1, 2023

STOCKHOLM , May 5, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") announced upcoming data presentations from the NeflgArd Phase 3 Study at the European Renal Association (ERA) Congress 2023. These data presentations will feature data and analyses from the NefIgArd Phase 3 clinical trial evaluating Nefecon (TARPEYO® (budesonide) delayed release capsules/Kinpeygo®) in patients with IgA nephropathy (IgAN).

Calliditas Announces Late-Breaking Presentations at the 60th European Renal Association (ERA) Congress 2023

Calliditas: A Trailblazing Triumph In IgAN Treatment.

Calliditas: A Trailblazing Triumph In IgAN Treatment

STOCKHOLM , April 26, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) today announces that the Annual Report for 2022 now is available at the company's website: www.calliditas.com For further information, please contact: Åsa Hillsten, Head of Investor Relations, Calliditas Therapeutics AB Phone: +46 764 03 35 43 E-mail: asa.hillsten@calliditas.com This information is information that Calliditas Therapeutics AB is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication at 21:00 CET on April 26, 2023.

Calliditas Therapeutics' 2022 Annual Report Published

Calliditas Therapeutics recently reported positive long-term data of Tarpeyo (Nefecon/budesonide) in patients with IgA nephropathy. The results confirmed the previous positive findings from the phase 3 trial and indicate a potential disease-modifying effect of Tarpeyo.

Calliditas Therapeutics: Good Long-Term Data Could Boost Tarpeyo Sales

NEW YORK, April 11, 2023 (GLOBE NEWSWIRE) -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”), announced the publication of a cost-effective analysis of Nefecon (marketed in the United States as TARPEYO® (budesonide) delayed release capsules) versus standard of care (SOC) for people with Primary IgA Nephropathy (IgAN) in the United States (US). The analysis was published in the peer-reviewed journal ClinicoEconomics and Outcomes Research .

Calliditas Announces Publication of Cost-Effectiveness Analysis of Nefecon versus Best Supportive Care for People with IgA Nephropathy in the United States

STOCKHOLM , March 31, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") today announced its management's participation in the following investor conferences:            The Guggenheim Genomic Medicines and Rare Disease Days Conference, which is being held in person April 3 at the Lotte New York Palace. Calliditas CEO Renee Aguiar-Lucander will participate in a company fireside chat and there will also be a KOL Panel regarding the evolution of IgA nephropathy treatment.

Calliditas to participate in upcoming investor conferences

NeoGenomics

Reata Pharmaceuticals

Reata Pharmaceuticals stock is soaring on the back of a recent FDA approval for a new rare disease drug. Calliditas Therapeutics stock recently jumped higher in response to positive trial results for its lead drug.

3 Supercharged Stocks Near 52-Week Highs That Could Keep Climbing

STOCKHOLM , March 13, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (NASDAQ: CALT) (NASDAQ Stockholm: CALTX) ("Calliditas") today announced positive topline results from the global, randomized, double-blind, placebo-controlled Phase 3 clinical trial NefIgArd, which investigated the effect of Nefecon (TARPEYO®/Kinpeygo® (budesonide) delayed release capsules) versus placebo in patients with primary IgA nephropathy (IgAN). The trial met its primary endpoint with Nefecon demonstrating a highly statistically significant benefit over placebo (p value < 0.0001) in estimated glomerular filtration rate (eGFR) over the two-year period of 9-months of treatment with Nefecon or placebo and 15-months of follow-up off drug.

Calliditas Announces Primary Endpoint Successfully Met in Phase 3 NefIgArd Trial Evaluating Nefecon® in IgA Nephropathy

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.

Calliditas: Underfollowed Swedish Biotech Focusing On Rare Kidney Disease

2022: Successful transformation into a commercial stage company STOCKHOLM , Feb. 23, 2023 /PRNewswire/ --  "2022 was a fantastic year for Calliditas as we launched TARPEYO® in the US, the first approved drug for IgA nephropathy and a medication with the potential to be disease modifying based on the early stabilization of eGFR in patients at risk of rapid disease progression. We achieved total revenues of SEK 802.9 million ($79.3m) for the year of 2022, which represent an increase of 250% compared to 2021, whereof SEK 372.2 million ($36.8m) was net sales of TARPEYO for the first 11 months of commercialization.

Calliditas - Year-End Report, 2022

STOCKHOLM , Feb. 2, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX)  ("Calliditas") today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom has granted Conditional Marketing Authorization (CMA) for Kinpeygo® for the treatment of primary immunoglobulin A (IgA) nephropathy (IgAN) in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram. Kinpeygo is the first and only approved treatment for IgAN, a rare, progressive autoimmune disease of the kidney with a high unmet need, with more than 50% of patients potentially progressing to end-stage renal disease (ESRD).

Calliditas Receives Conditional Marketing Authorization from UK MHRA for Kinpeygo in IgA nephropathy

CALT has an approved product in the US and EU in IgAN. However, the rest of its pipeline consists of an unconvincing single product with a history of failure.

Calliditas: Low Cash And Unconvincing Pipeline

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Dream Finders Homes

CALT, CVGW and DFH have been added to the Zacks Rank #5 (Strong Sell) List on January 6, 2023.

New Strong Sell Stocks for January 6th

STOCKHOLM , Dec. 30, 2022 /PRNewswire/ -- Calliditas Therapeutics AB (publ) ("Calliditas") partner Everest Medicines (HKEX 1952.HK) today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has recommended Priority Review for the New Drug Application (NDA) of Nefecon for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of rapid disease progression. In November 2022 the NMPA accepted Everest's NDA for Nefecon, leading to an expected regulatory decision in 2H 2023.

China CDE/NMPA Recommends Priority Review for Nefecon for the Treatment of Primary IgA Nephropathy

STOCKHOLM , Dec. 21, 2022 /PRNewswire/ -- Calliditas Therapeutics AB (publ) (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") announced today that CEO Renée Aguiar-Lucander has net purchased 50,000 shares through Calliditas' warrant program 2019/2022. Following the new subscription for shares, her shareholding in the company will amount to 643,000 common shares.

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