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Our Expertise Helps Patients in Need

Calliditas is dedicated to expanding treatment options and establishing new standards of care for people with rare diseases. By drawing on our expertise in pharmaceutical product development and leveraging our strategic partnerships, we quickly and efficiently identify, develop, and market a pipeline of innovative medicines that can improve the lives of patients. We successfully commercialized our lead candidate in the United States, and in collaboration with our partners, launched in Europe, with plans to seek approval in Asia.

LEADERSHIP

Calliditas is led by an experienced and dedicated management team. The team has a strong knowledge of the pharmaceutical industry, as well as commercial and general management expertise. Our broader leadership team has experience from companies such as GlaxoSmithKline, Pfizer, Novo Nordisk, Regeneron, BMS and AstraZeneca.

MANAGEMENT TEAM

Renée Aguiar-Lucander

Renée Aguiar-Lucander

Chief Executive Officer
Renée Aguiar-Lucander

Renée Aguiar-Lucander

Chief Executive Officer

Born 1962. CEO since 2017.

Education:
BA in Finance from Stockholm School of Economics. MBA from INSEAD.

Experience:
Before joining Calliditas, Renée Aguiar-Lucander was a Partner and COO of Omega Fund Management, an international venture capital company focused on investments within the life science sector. Before that, she served as a Partner in the venture capital group 3i Group plc in London, where she managed the publicly quoted assets and was co-head of the global healthcare and technology portfolio. Prior to this, Renée Aguiar-Lucander was the European Group Head and Managing Director at a global investment bank and has more than 12 years’ experience in corporate finance. Prior to her career in investment banking, she was the Head of European Sales and Marketing in a company focused on the sale of software for financial services.

Other current assignments: –

Holdings in the Company:
Renée Aguiar-Lucander holds 643,000 shares in the Company and 841,000 options.

Frank Bringstrup

Frank Bringstrup

Vice President Regulatory Affairs
Frank Bringstrup

Frank Bringstrup

Vice President Regulatory Affairs

Born 1959. VP Regulatory Affairs since 2019.

Education:
Medical education from the University of Copenhagen. He has a diploma in Managing Medical Product Innovation (MMPI) from the Copenhagen School of Economics, a diploma in business administration from Warwick University, and a post graduate specialist course in public health science from the National Board of Health, Denmark.

Experience:
Frank Bringstrup has over 17 years of experience in the pharmaceutical industry within regulatory affairs and health authority interactions. Prior to joining Calliditas, he worked in various positions at Novo Nordisk A / S. He started his professional career first as a clinic doctor and then Frederiksborg County Medical Advisor.

Holding in the Company:
Frank Bringstrup holds 8,000 shares in the Company and 135,000 options.

calliditas-management-Maria-tornsen-image

Maria Törnsén

President, North America
calliditas-management-Maria-tornsen-image

Maria Törnsén

President, North America

Born 1978. President, North America since 2024.

Education:
MSc in International Business Administration from Lund University, Sweden.

Experience:
Maria Törnsén has more than 20 years of experience in the pharmaceutical industry. Maria is currently a Board Director for Immunic Therapeutics and before joining Calliditas, she worked as Chief Commercial Officer at Passage Bio. Prior to Passage Bio, Maria held various commercial leadership roles at Sarepta, Sanofi and Shire. Maria began her career at Eli Lilly in sales and also worked at Merck KGaA in sales and marketing.

Maria Törnsén holds no shares or options in the Company.

calliditas-brian-gorman-people

Brian Gorman

Group General Counsel
calliditas-brian-gorman-people

Brian Gorman

Group General Counsel

Born 1976. Group General Counsel since 2023.

Education:
Bachelor’s Degree from Gettysburg College, J.D from Villanova University School of Law.

Experience:
Brian is an accomplished legal and business executive with more than 20 years of experience advising corporate boards and executive management teams of life science companies. He joins Calliditas after having served most recently as Executive Vice President, Corporate Development & General Counsel at Opiant Pharmaceuticals, which was acquired by Indivior PLC.  Prior to Opiant, Brian held senior legal leadership roles at Endo Pharmaceuticals, AstraZeneca and Wyeth Pharmaceuticals (now Pfizer). He began his career at the international law firm, Cleary Gottlieb Steen & Hamilton.

Holdings in the Company:
Brian Gorman holds 75,000 options.

Fredrik Johansson

Fredrik Johansson

Chief Financial Officer
Fredrik Johansson

Fredrik Johansson

Chief Financial Officer

Born 1977. CFO since 2017.

Education:
Studies in Business Law at Jönköping International Business School. Studies in Business and American law, Economics and Finance at Georgia State University, University of South Carolina and Lund University.

Experience:
Fredrik Johansson has extensive experience in executive positions, primarily within telecom and software. Previously, he was CFO and COO at Birdstep Technology/ Techstep ASA, listed on the Oslo Stock Exchange, where he, among other things, was in charge of the acquisition and reversed listing of Teki Solutions. Previous CFO positions also include Phone Family, Teligent Telecom and Wayfinder Systems.

Holdings in the Company:
Fredrik Johansson holds 42,750 shares in the Company and 305,000 options.

Richard Philipson

Richard Philipson

Chief Medical Officer
Richard Philipson

Richard Philipson

Chief Medical Officer

Born 1964. Chief Medical Officer since 2020.

Education:
BSc in Biomedical Sciences at London University and MB MS, Middlesex Hospital Medical School. Fellow of the Royal College of Physicians and Fellow of the Faculty of Pharmaceutical Medicine.

Experience:
Dr. Richard Philipson is a physician with 24 years of experience in the pharmaceutical industry from both large pharmaceutical companies and smaller biotechs. He has extensive experience in rare diseases, having brought several products from early development to the market. Prior to joining Calliditas, Richard worked as CMO with the UK-based biotech company Trizell where he led the Adstiladrin® phase 3 clinical program and Biologics License Application in non-muscle invasive bladder cancer, submitted to the FDA in September 2019. Before Trizell, he worked for Takeda as an Executive Medical Director and spent 16 years at GlaxoSmithKline, where he held a number of senior positions, including Disease Area Head and Acting Chief Medical Officer for the Rare Diseases Unit.

Before joining the industry, Richard worked as a physician in several clinical positions with various patient populations, including patients with IgA nephropathy.

Holdings in the Company: 270,000 options.

calliditas-lars-people

Lars Stubberud

Head of Techincal Operations
calliditas-lars-people

Lars Stubberud

Head of Techincal Operations

Born 1964. Head of Technical Operations since 2023.

Education:
Master of Science (candidatus pharmaciae) and PhD in Pharmaceutical Science from the University of Oslo, Norway.

Experience:
Lars Stubberud has more than 30 years experience in the pharmaceutical industry, within the broader CMC area, including Formulation Sciences, Product Development, Technology Transfer/Technical Stewardship as well as Regulatory Affairs- CMC and Quality Assurance. Prior to joining Calliditas Lars has held various positions, including leadership roles, at Nyomed AS, Norway, AstraZeneca Sweden, as well as Cubist Pharmaceuticals GmbH, Biogen International GmbH and Alexion Pharma GmbH in Switzerland.

Holdings in the company:
Lars Stubberud holds 100 000 options.

Sandra Frithiof

Sandra Frithiof

Head of Human Resources
Sandra Frithiof

Sandra Frithiof

Head of Human Resources

Born 1975. Head of HR since 2020.

Education:
Bachelor’s Degree in Human Resource Management from Örebro University, Sweden.

Experience:
Sandra Frithiof has more than 23 years of HR experience in different industries. Before joining Calliditas Sandra worked as Head of HR and COO at Ramberg Advokater. Previous HR positions also include Karolinska University Hospital, UTC, CGI and Manpower Group.

Holdings in the Company:
Sandra Frithiof holds 105,000 options.

Shareholding in the Company as of December 31, 2022.

For more information on the warrants, see section Remuneration.

BOARD OF DIRECTORS

Elmar Schnee

Elmar Schnee

Chairman
Elmar Schnee

Elmar Schnee

Chairman

Born 1959. Board member since 2019.

Education:
Master’s degree in marketing and management from SIB.

Board Committees:
Chairman of the Remuneration Committee.

Experience:
Elmar Schnee was previously CEO of Merck Serono and was instrumental in the acquisition of Serono by Merck KGaA. He has also served as General Partner and member of the Executive Board of Merck KGaA and has held previously several senior global management positions with UCB and Sanofi.

Other current assignments:

Chairman of the board of directors of ProCom Rx SA, Moleac Pte Lts and Noorik Biopharmaceuticals AG, Executive Chairman EnteroBiotix as well as a member of the board of directors of Kuste Biopharma, Mindmaze SA and Damian Pharma AG.

Holdings in the Company:
Elmar Schnee holds 33,236 shares in the company, 10,624 share awards in LTIP 2021, 13,926 share awards in LTIP 2022 and 14,012 share awards in LTIP 2023.

Independent in relation to the Company and its management and in relation to major shareholders.

Chairman of the Board
Chair of the Remuneration Committee
Member of the Board of Directors
Member of the Remuneration Committee
Member of the Nomination Committee
Elisabeth Björk

Elisabeth Björk

Non-executive Director
Elisabeth Björk

Elisabeth Björk

Non-executive Director

Born 1961. Board member since 2022.

Education:
MD degree, Karolinska Institute, Stockholm and Associate Professor, Medicine, Uppsala University

Board Committees:
Member of the Remuneration Committee.

Experience:
Elisabeth Björk is an endocrinologist by training and an associate professor of medicine at Uppsala University, Sweden. Elisabeth Björk has been the Senior Vice President, Head of Late-stage Development, Cardiovascular, Renal and Metabolism (CVRM), BioPharmaceuticals R&D at AstraZeneca leading the global development of medicines within this area since 2012. Throughout her career at AstraZeneca, she has gained broad drug development experience covering clinical development phase I-IV, large outcomes programs, major global filings and health authority interactions (FDA, EMA, Japan) and commercial strategy/implementation.

Other current assignments:
Board member in Rocket Pharmaceuticals, Pharvaris NV, Vicore Pharma AB, Chalmers University of Technology, Betula Consulting AB.

Holdings in the Company:
Elisabeth Björk holds 5,356 share awards in LTIP 2022 and 5,389 share awards in LTIP 2023.

Independent in relation to the Company and its management and in relation to major shareholders.

Member of the Board of Directors
Member of the Remuneration Committee
Fred_Driscoll

Fred Driscoll

Non-executive Director
Fred_Driscoll

Fred Driscoll

Non-executive Director

Born 1950. Board member since 2023.

Education:
B.S. Accounting, Bentley University.

Board Committees:

Experience:
Mr. Driscoll has served as Interim Chief Financial Office at Invivyd, Inc. from Oct. 2022 to May 2023. Since May 2021 until Nov. 2021, Mr. Driscoll served as Chief Financial Officer at Flexion Therapeutics which was acquired by Pacira Biosciences, a role he previously served from 2013 to 2017, spearheading the initial public offering in 2014. Prior to joining Flexion Therapeutics, he was Chief Financial Officer at Novavax, Inc., a publicly traded biopharmaceutical company, from 2009 to 2013. From 2008 to 2009, Mr. Driscoll served as Chief Executive Officer of Genelabs Technologies, Inc., a publicly traded biopharmaceutical and diagnostics company later acquired by GlaxoSmithKline. He previously served as Genelabs’ Chief Financial Officer from 2007 to 2008. From 2003 to 2006, Mr. Driscoll served as Chief Executive Officer at OXiGENE, Inc., a biopharmaceutical company and from 2000 to 2003 as Chief Financial Officer. Mr. Driscoll has also served as Chairman of the Board and Audit Committee Chair at OXiGENE and as a member of the Audit Committee for Cynapsus, which was sold to Sunovion Pharmaceuticals in 2016.

Other current assignments:
Mr. Driscoll currently serves as a board member for Cellectar BioSciences, Cue BioPharma and MEI Pharma.

Holdings in the Company:
5,389 share awards in LTIP 2023.

Independent in relation to the Company and its management and in relation to major shareholders.

Member of the Board of Directors
Hilde Furberg

Hilde Furberg

Non-executive Director
Hilde Furberg

Hilde Furberg

Non-executive Director

Born 1958. Board member since 2014.

Education:
Master of Science from Oslo University, Norway.

Board Committees:
Member of the Audit Committee.

Experience: Hilde Furberg is an independent consultant and professional Board member. She has extensive experience of leadership from her 35 years in sales, marketing, strategy and management in Pharma/Biotech. Her experience is in various therapeutic areas which she gained working in small companies and large global corporations. Hilde has worked in companies such as Genzyme and Baxter, she was most recently SVP and General Manger / European Head of Rare Diseases at Sanofi Genzyme. In addition to working for Genzyme/Sanofi Genzyme, Hilde has since 2005 worked as non-executive director and Board member of Probi, Pronova, Clavis, Bergenbio and Algeta.

Other current assignments:
She is currently an industrial advisor to Investinor and Board member of PCI Biotech, Herantis Pharma, Sedana Medical, Bio-Me and Pluvia Biotech.

Holdings in the company:
Hilde Furberg holds 53,199 shares in the company, 4,086 share awards in LTIP 2021, 5,356 share awards in LTIP 2022 and 5,389 share awards in LTIP 2023.

Independent in relation to the Company and its management and in relation to major shareholders.

Member of the Board of Directors
Member of the Audit Committee
Diane Parks

Diane Parks

Non-executive Director
Diane Parks

Diane Parks

Non-executive Director

Born 1952. Board member since 2019.

Education:
Master’s degree from Kansas State University and an MBA from Georgia State University.

Board Committees:
Member of the Remuneration Committee.

Experience:
Diane Parks is a senior executive with deep sales and marketing experience from the US, where she has held positions such as Head of US Commercial for Kite Pharma, VP of Sales for Amgen and Head of Global Marketing at Pharmacyclics.

Other current assignments:
Board member in TriSalus Life Sciences, Kura Oncology, Soligenix and Celularity.

Holdings in the Company:
Diane Parks holds 8,499 shares in the company, 4,086 share awards in LTIP 2021, 5,356 share awards in LTIP 2022 and 5,389 share awards in LTIP 2023.

Independent in relation to the Company and its management and in relation to major shareholders.

Member of the Board of Directors
Member of the Remuneration Committee
Henrik Stenqvist

Henrik Stenqvist

Non-executive Director
Henrik Stenqvist

Henrik Stenqvist

Non-executive Director

Born 1967. Board member since 2022.

Education:
Master of Science in Business Administration and Economics, University of Linköping.

Board Committees:
Chairman of the Audit Committee.

Experience:
Henrik Stenqvist has served as CFO of several listed life science companies and currently, he is the CFO of SOBI. Previous positions include CFO at Recipharm, CFO at Meda, Regional Finance Director at AstraZeneca, Finance Director at Astra Export & Trading and Board member of MedCap AB.

Other current assignments:
Board member in Midsona AB.

Holdings in the company:
Henrik Stenqvist holds 10,000 shares in Calliditas, 5,356 share awards in LTIP 2022 and 5,389 share awards in LTIP 2023.

Independent in relation to the Company and its management and in relation to major shareholders.

Chairman of the Audit Committee
Member of the Board of Directors
Shareholding in the Company as of February 28, 2023.*
For more information on the incentive programs, see section Remuneration.

OUR HISTORY

Since our founding in 2004, Calliditas has worked to deliver life-changing medications to patients in need.

2023

TARPEYO RECEIVES FULL APPROVAL IN THE UNITED STATES

On December 20, 2023, the United States (US) Food and Drug Administration (FDA) granted Calliditas full approval of TARPEYO® (budesonide) delayed release capsules to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression.

STRENGTHENING TARPEYO’S IP

The United States Patent and Trademark Office (USPTO) provided Notice of Allowance for patent application no. 18/100,396 entitled “New Pharmaceutical Compositions.”.

PARTNERSHIPS’ MILESTONES ACHIEVED

Commercial partner, Everest Medicines, received approval from China’s National Medical Products Administration (NMPA) of Nefecon® for the treatment of primary IgAN iIn adults at risk of disease progression.

Everest Medicines received approval from the Pharmaceutical Administration Bureau of the Macau Special Administrative Region, China.

Commercial partner, STADA Arzneimittel AG, submitted a request to the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom to convert the conditional marketing authorization (CMA) for Kinpeygo® to standard, or “full”, marketing authorization.

The MHRA of the United Kingdom granted CMA for Kinpeygo for the treatment of IgAN in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram.

STADA request to the EMA to convert conditional marketing authorization to standard marketing authorization for Kinpeygo treatment for primary IgAN.

ADVANCING SCIENCE AND OTHER NEWS

The Lancet published the full data from the Phase 3 NefIgArd study.

The FDA accepted the submission for the supplemental New Drug Application (sNDA) for TARPEYO and granted Priority Review.

Positive topline results from the global, randomized, double-blind, placebo-controlled Phase 3 clinical trial NefIgArd were announced.

PROMISE OF NOX INHIBITORS RECOGNIZED

EMA Committee for Orphan Medicinal Products (COMP) issued a positive opinion on the company’s application for orphan drug designation in the European Union (EU) for setanaxib in Alport syndrome

US FDA  granted orphan drug designation (ODD) to setanaxib for the treatment of Alport syndrome

Interim data from the proof-of-concept Phase 2 trial in patients with squamous cell carcinoma of the head and neck (SCCHN) with setanaxib was announced. The analysis reflected encouraging early clinical progression-free survival (PFS) results and supports the presumed anti fibrotic mode of action of setanaxib.

Calliditas announced supportive interim data from Phase 2 head and neck cancer trial with lead NOX inhibitor candidate, setanaxib. The analysis reflected encouraging early clinical progression-free survival (PFS) results and supports the presumed anti fibrotic mode of action of setanaxib.

2022

COMMERCIAL LAUNCH OF TARPEYO in the US

TARPEYO® (budesonide) delayed release capsules became commercially available in the United States

NEFECON IN EUROPE, CHINA AND OTHER REGIONS

Following a positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), the European Commission (EC) approved KINPEYGO in Europe, granting Calliditas a conditional marketing authorization for adults with primary IgA nephropathy at risk of rapid disease progression

Chinese Regulatory authority National Medical Products Administration (NMPA) accepted Everest Medicines’ New Drug Application for NEFECON

ADVANCING PIPELINE WITH SETANAXIB

The first patient was randomized in pivotal phase 2b/3 TRANSFORM study in patients with primary biliary cholangitis (PBC)

The first patient was randomized in the Phase 2 Proof of Concept study in patients with Head and Neck cancer

2021

TARPEYO RECEIVES FDA APPROVAL IN IgA NEPHROPATHY

Deleted: On December 15, 2021, the FDA granted Calliditas accelerated approval of TARPEYO to reduce proteinuria in patients with IgA nephropathy. TARPEYO became the first and only approved treatment for this indication

Submitted a New Drug Application to the United States (US) FDA and a Marketing Authorization Application to the European Medicines Agency for patients with primary IgA nephropathy

Announced full enrollment of the Phase 3 NeflgArd trial

EUROPEAN COMMERCIAL PARTNERSHIP

Partnered with STADA Arzneimittel AG to register and commercialize a specialty therapy for IgA Nephropathy in Europe

GENKYOTEX ACQUISITION

Completed acquisition of Genkyotex, which became a wholly owned subsidiary of Calliditas and was delisted from the Euronext stock exchanges

SECURING FINANCING

Resolved on a directed share issue in the amount of 2.4 million shares, raising proceeds of approximately SEK 324 million

Secured a USD 75 million term loan facility from Kreos Capital

2020

SUCCESSFUL TOPLINE PHASE 2 DATA OF NEFECON

Announced positive topline results from the pivotal Phase 3 NeflgArd trial

US INITIAL PUBLIC OFFERING (IPO)

Listed on the NASDAQ Global Select Market, raising approximately USD 90 million

ACQUISITION OF GENKYOTEX

Acquired a controlling interest in Genkyotex SA

2019

CALLIDITAS ENTERS INTO GLOBAL PARTNERSHIPS

Calliditas and Everest Medicines entered into a licensing agreement to develop and commercialize Calliditas’ leading product candidate in Greater China and Singapore

ADVANCING THE PIPELINE

Finished recruitment for the pivotal Phase 3 clinical trial NeflgArd Part A
Exclusively in-licensed Budenofalk 3 mg oral capsules for the US market from the German pharmaceutical company. Dr. Falk Pharma GmbH

CALLIDITAS ESTABLISHED A US PRESENCE

Appointment of VP Commercial, North America

2018

FIRST PATIENT ENROLLED IN PIVOTAL PHASE 3 STUDY

First patient enrolled in pivotal clinical phase 3 study NefIgArd with lead candidate NEFECON

LISTING ON NASDAQ STOCKHOLM

Listed on NASDAQ Stockholm’s main list, raising approximately SEK 739 million

2017

INTRODUCING CALLIDITAS THERAPEUTICS

Pharmalink is renamed Calliditas Therapeutics

ADVANCING CLINICAL TRIALS

Positive results of Phase 2b Clinical Trial of Nefecon in Primary IgA Nephropathy published in The Lancet

Use of proteinuria as a surrogate marker and design of Phase 3 study accepted by the FDA

2016

ORPHAN DRUG DESIGNATION IN EUROPE

Obtained orphan drug designation from the EMA for lead product candidate NEFECON in Europe

PUBLICATION ON PROTEINURIA AS A SURROGATE ENDPOINT

Tufts Medical Center publishes the meta-analysis study related to changes of proteinuria as a surrogate endpoint in IgA Nephropathy in American Journal of Kidney Disease

2015

COLLABORATION WITH KIDNEY HEALTH INITIATIVE

Invited to work with the Kidney Health Initiative (American Society of Nephrology) to identify surrogate endpoints in IgA Nephropathy

ADVANCING CLINICAL PROGRAM

Announced positive initial results from Phase 2B NEFIGAN trial, which met its primary endpoint in a planned interim analysis

2014

Global Patents Awarded

Core patents for lead product candidate were granted in the US, Europe, China and Hong Kong

2012

Phase 2b Trial Launches

Owners, including Industrifonden and Bengt Julander, financed the launch of the pivotal Phase 2b NEFIGAN trial

2011

GAINS EXCLUSIVE RIGHTS TO FORMULATION TECHNOLOGY

Pharmalink gained exclusive rights to the formulation technology, TARGIT®, for developing and manufacturing lead product candidate under a 2011 agreement with Archimedes Development Ltd

2010

OBTAINED ORPHAN DRUG DESIGNATION

Pharmalink obtained orphan drug designation from the FDA for lead product candidate in the United States

2009

POSITIVE PHASE 2 STUDY COMPLETED

The Phase 2a study with lead product candidate was completed with positive results

2008

Lead Product Development

Identified the company’s lead product candidate

2004

Company Founded

Calliditas was founded in 2004 under the name Pharmalink AB and was registered with the Swedish Companies Registration Office on April 15, 2004