Calliditas Therapeutics IPO Presentation Deck

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Calliditas Therapeutics

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calliditas-therapeutics

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June 2020

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#1calliditas THERAPEUTICS Company Overview June 2020#2Disclaimers Important information Calliditas Therapeutics AB (the "Company") has filed a registration statement (including a preliminary prospectus) with the Securities and Exchange Commission ("SEC") for the offering to which this presentation relates. Before you invest, you should read the preliminary prospectus in that registration statement and the other documents the Company has filled with the SEC for more complete information about the Company and the offering. You may get these documents for free by visiting EDGAR on the SEC website at www.sec.gov. Alternatively, the Company or any underwriter or dealer participating in this offering will arrange to send you the prospectus if you request it from Citigroup Global Markets Inc., c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: 1-800-831-9146, or email [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022, via telephone: 877-821-7388 or via email: [email protected]; or Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, or by telephone at (415) 364-2720 or by email at [email protected]. This presentation shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. The presentation does not purport to give legal, tax or financial advice, and must not be relied upon for any such purpose. Neither the information contained in this presentation, nor any further information made available by the Company or any of its affiliates or employees, directors, representatives, officers, agents, or advisors, in connection with this presentation will form the basis of or be construed as a contract or any other legal obligation. This presentation may contain certain forward-looking statements and opinions. Forward-looking statements are statements that do not relate to historical facts and events and such statements and opinions pertaining to the future that, by example, contain wording such as "believes", "estimates", "anticipates", "expects", "assumes", "forecasts", "intends", "could", "will", "should", "would", "according to estimates", "is of the opinion", "may", "plans", "potential", "predicts", "projects", "to the knowledge of or similar expressions, which are intended to identify a statement as forward-looking. This applies, in particular, to statements and opinions in this presentation concerning our future business expectations, the therapeutic potential and clinical development of our product candidates, including with respect to trial design, enrollment, milestones and data readout, the regulatory pathways for our product candidates, including our plans for the submission of marketing applications to the regulatory authorities in the relevant jurisdictions for approval of our product candidates, our plans for pre-commercial and, if approved, commercial activities that we may undertake to market our product candidates, our collaborations for the development and commercialization of our product candidates, the market opportunity for the disease indications that our product candidates are intended to address, our plans for the in-licensing or acquisition of additional product candidates for our pipeline, our future financial returns, plans and expectations with respect to our business and management, future growth and profitability and general economic and regulatory environment and other matters affecting our company. Forward-looking statements are based on current estimates and assumptions made according to the best of our knowledge. Such forward-looking statements are subject to risks, uncertainties, and other factors that could cause the actual results, including with respect to our business, cash flow, financial condition and results of operations, to differ materially from the results, or fail to meet expectations expressly or implicitly assumed or described in those statements or to turn out to be less favorable than the results expressly or implicitly assumed or described in those statements. Accordingly, readers should not place undue reliance on the forward-looking statements herein. We can give no assurance regarding the future accuracy of the opinions set forth herein or as to the actual occurrence of any predicted developments. In light of the risks, uncertainties and assumptions associated with forward-looking statements, it is possible that the future events mentioned in this presentation may not occur. Actual results, performance or events may differ materially from those in such statements due to, without limitation, risks generally associated with pharmaceutical development, including delays or challenges that may arise in the clinical development of our product candidates, interactions with regulatory authorities, the impacts of the COVID-19 pandemic, challenges in the commercialization of our product candidates, if approved, the risk that we may not maintain our existing collaboration or enter into new ones, or that we will not realize the intended benefits from such collaborations, any inability to expand our pipeline of product candidates, any inability to maintain barriers to entry such as intellectual property protection or regulatory exclusivity, changes in general economic conditions, in particular economic conditions in the markets on which we operate, changes affecting interest rate levels, changes affecting currency exchange rates, changes in competition levels and changes in laws and regulations. The information, opinions and forward-looking statements contained in this announcement speak only as at its date, and are subject to change without notice. Certain information, including certain forward-looking estimates and forecasts, contained in this presentation relates to or is based on studies, publications, surveys and other data obtained from third-party sources and the Company's own internal estimates and research. While the Company believes these third-party sources to be reliable as of the date of this presentation, it has not independently verified, and makes no representation as to the adequacy, fairness, accuracy or completeness of any information obtained from third-party sources. In addition, all of the market data included in this presentation involves a number of assumptions and limitations, and there can be no guarantee as to the accuracy or reliability of such assumptions. Finally, while we believe our own internal research is reliable, such research has not been verified by any independent source.#3Offering Summary Issuer Symbol / Exchange Securities Offered Estimated Gross Proceeds (Pre-Greenshoe) Greenshoe Use of Proceeds Expected Pricing Lock-Up Period Bookrunners Co-Manager calliditas Calliditas Therapeutics AB CALT/Nasdaq Global Market CALTX/Nasdaq Stockholm Global offering of common shares, including common shares in the form of ADSS in the U.S. offering and common shares in the European private placement $75 million 15% (in the form of ADSS) To fund the ongoing Phase 3 clinical trial and related trials of Nefecon and, if the results from Part A of this Phase 3 clinical trial are positive, to file for regulatory approval in the U.S and the E.U. To fund pre-commercial and, if approved, commercial activities for Nefecon for the treatment of IgAN; and To fund the development of additional product candidates in indications for which Nefecon or its active ingredient may have therapeutic potential, including PBC and AIH, or for any product candidates that are in- licensed or acquired, and for working capital and other general corporate purposes June 4th 90 Days Citigroup, Jefferies, and Stifel Carnegie June 2020 3#4Management team RENÉE AGUIAR-LUCANDER CEO Selected experience: Partner and COO of Omega Fund Management, Partner and Co- Head of the European & U.S. legacy healthcare & technology portfolio at 3i group Dr. KRASSIMIR MITCHEV Acting CMO Selected experience: Senior Global Clinical Development and Medical Affairs Leadership positions at UCB, GSK and Sobi. Most recent as Vice President and Medical Head at Sobi FRANK BRINGSTRUP VP Regulatory Affairs Selected experience: 17 years of experience in the pharmaceutical industry within regulatory affairs and health authority interactions. Most recent various positions at Novo Nordisk calliditas Dr. JENS KRISTENSEN Senior Medical Advisor (CMO until Dec-19) Selected experience: Senior positions at AstraZeneca, CMO and Head of Development at KaroBio and Medivir ANDREW UDELL VP Commercial North America Selected experience: 20 years of commercial experience in pharma industry, most recent VP of North America Commercial at NeuroDerm; several sales and marketing positions at Purdue Pharma KATY WELIN-BERGER VP Operations Selected experience: 15 years of experience in pharma industry within business operations; most recent VP of Operations at BioGala AB; several business operations positions at AstraZeneca FREDRIK JOHANSSON CFO Selected experience: CFO and COO at Birdstep Technology/Techstep, CFO at Phone Family, Teligent Telecom and Wayfinder Systems JOHAN HÄGGBLAD Cso Selected experience: Managerial and executive roles at KaroBio AB Pharmacia Corporation and NeuroNova ANN-KRISTIN MYDE VP Project Management Selected experience: Project management positions at Kabi Pharmacia and AstraZeneca Experience from leading several global drug development and clinical project teams June 2020 4#5calliditas THERAPEUTICS A clinical-stage biopharma company focused on novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet needs Lead product candidate, Nefecon, being developed for the treatment of IgA Nephropathy (IgAN), a serious progressive autoimmune disease of the kidney with no currently approved treatments Part A of Pivotal Phase 3 trial in IgAN fully recruited with topline readout expected in 4Q 2020; anticipated NDA and MAA filings in 1H 2021 for accelerated approval in U.S. and conditional approval in E.U. Headquartered in Stockholm, Sweden; listed on OMX NASDAQ in Sweden - Midcap segment (ticker: CALTX) Market cap as of May 27, 2020: ~US$392 million; Cash balance as of March 31, 2020: US$77 million, providing financing into 2H 2021 through planned regulatory filings for marketing approval in the U.S. and E.U. Key institutional shareholders include: Industrifonden (swe), Investinor (nor), BVF Capital, Vivo Capital, Sofinnova Partners calliditas June 2020 5#6Calliditas pipeline Program Nefecon (budesonide) Indication IgA Nephropathy Primary Biliary Cholangitis Research/ Preclinical Phase 1 Planned Phase 3(¹2) Phase 2 Phase 3 Marketed/ Approved (1) Pursuing accelerated approval pathway in the United States, an expedited pathway, and conditional approval pathway in the European Union. (2) Pursuing under the Section 505(b)(2) pathway in the United States and, as applicable, hybrid application pathway in the European Union. calliditas Upcoming Milestone(s) 4Q 2020: Topline Part A Phase 3 data 1H 2021: Assuming successful completion of Part A of the Phase 3 trial, file NDA and MAA 1Q 2021: FDA discussions on development plans Commercial Rights calliditas Worldwide, ex-Greater China and Singapore calliditas Worldwide In addition, we have in-licensed Budenofalk 3 mg oral capsules and intend to develop Budenofalk in the United States for the treatment of AIH, subject to regulatory feedback. We plan to discuss our development plans with the FDA for AIH in 2020. June 2020 6#7Investment highlights 1 Nefecon is a proprietary, novel treatment for IgAN intended to be disease modifying Nefecon targets the presumed origin of the disease - the area of the ileum where the highest concentration of Peyer's patches are located 2 3 4 5 6 7 Nefecon is the most advanced product candidate for IgAN. The only successful randomized, double-blind, placebo-controlled Phase 2b clinical trial carried out in IgAN to date Ongoing pivotal Phase 3 clinical trial (NeflgArd) using the same primary endpoint as previous successful Phase 2b trial Regulatory pathway based on FDA and EMA acceptance of accelerated / conditional approval based on proteinuria as surrogate marker for IgAN Significant unmet medical need in IgAN with no currently approved treatments; total market opportunity of US$9-10bn in the U.S alone. Additional potential for pipeline development and in-licensing of product candidates targeting orphan diseases calliditas 539 410 200 100 7 60 June 2020 7#8Our lead indication: IgA Nephropathy - significant unmet medical need PROFILE Progressive autoimmune disease Genetic predisposition - required but not sufficient; environmental, bacterial, dietary factors Normally diagnosed in ages 20-30 More prevalent in men than in women in the West Up to 50% at risk of developing ESRD within 10-20 years calliditas Level of protein in the urine (proteinuria) is correlated with traditional outcome measure of kidney function (eGFR) High levels of proteinuria indicate disease progression and increased risk of ESRD MAIN MARKETS Treatment options ESTIMATED PREVALENCE 130,000-150,000 Source: 1) Estimates in Greater China and Japan based in part on published prevalence among ethnic patient populations in U.S., analyses of prevalence in Europe and published incidence rates in certain geographies. 200,000 2,000,000¹ There is no approved treatment Virtually all patients are prescribed blood pressure-lowering agents (ACES and ARBS) *As disease progresses, systemic immunosuppressive agents, primarily consisting of high doses of systemic corticosteroids are used by some nephrologists Randomized trials involving these off-label immunosuppressant treatments have either failed to show efficacy or shown severe metabolic and infectious side effects, including mortality 180,000¹ June 2020 8#9Disease origin and progression - predominant theory IgA-dependent immune complex Liver Peyer's patches Gallbladder Peyer's Patches- Follicles of lymphatic tissue, known as Peyer's patches, in the distal part of the small intestine (ileum) produce secretory IgA antibodies Galactose-deficient IgA Patients with IgAN have an increased appearance in the blood of secretory IgA antibodies that lack galactose units (galactose-deficient IgA) in the hinge region, which makes the antibody immunogenic Immune recognition These IgA antibodies trigger autoantigen production and form autoantibody complexes with autoantibodies directed against the IgA hinge region 3 9 These aggregates form pathogenic immune complexes that deposit in the glomeruli, which are the filtration apparatus of the kidney Source: Suzuki et al, J Am Soc Nephrol 2011;22(10):1795-803; Novak et al, Curr Opin Nephrol Hypertens 2013; 22(3):287-94; Novak et al, Kidney Dis (Basel). 2015; 1(1):8-18 calliditas 4 IgA Nephropathy The deposits of immune complexes in the glomeruli cause an inflammatory cascade that destroys the glomeruli, reducing the kidney's ability to remove waste products from the blood and eventually may result in ESRD June 2020 9#10Nefecon targets the presumed origin of disease Drug product based on known active ingredient Active ingredient is budesonide - an established, highly potent, locally acting corticosteroid 90% cleared in first pass metabolism by liver → minimize systemic side effects Designed to deliver a targeted and highly concentrated dose of budesonide directly to the Peyer's patches calliditas Liver Novel targeted release profile Designed for targeted local delivery of potent immunosuppressant to Peyer's patches in the ileum Differentiated release profile pH-governed delayed disintegration of the capsule until it reaches the ileum Potent, sustained exposure throughout the ileum Budesonide Concentration Stomach SEM of Peyer's patches Duodenum & Jejunum lleum Nefecon Time Colon June 2020 10#11Strong product protection and product exclusivity for Nefecon Orphan designation Existing patents Patent strategy Soft barriers calliditas Granted orphan drug designation in the U.S. and E.U. Potential data protection and market exclusivity for 7 years (U.S.) and 10 years (E.U.) Calliditas has been granted patents covering Nefecon, its formulation and method of manufacturing The formulation patent runs until 2029 Strategic focus on the U.S. and Europe with extension into other geographical markets Significant formulation and manufacturing know-how Questionable relevance of bioequivalence studies Nefecon is the most advanced candidate in development June 2020 11#12Confirmatory proof of concept observed in Phase 2b trial Only Phase 2b trial in IgAN to meet key primary and secondary endpoints Large trial population - Oral dose taken daily over a nine- month period 150 patients Randomized, double-blinded, placebo-controlled Primary endpoint: Reduction in proteinuria % & UPCR Placebo (27.3%) Nefecon (16 mg) p < 0.01 calliditas B (21.5%) Nefecon p<0.03* Secondary endpoint: Stabilization of eGFR % A eGFR European trial in 62 sites in 10 countries Note: Study results published in The Lancet, 2017. * Not statistically significant based on p-0.0158 to define statistical significance. Placebo -4.7ml/min*1.73m² Nefecon (16 mg) p = 0.0026 Nefecon (8 mg) p = 0.0064 L wwww Efficacy findings Phase 2b trial of 150 patients demonstrated statistically significant and clinically meaningful reduction in proteinuria and eGFR stabilization in the 16 mg dose cohort Statistically significant UPCR reduction with Nefecon (16 mg) compared to placebo - 9 months treatment (p<0.01) Statistically significant eGFR stabilization with Nefecon (16 mg) compared to placebo - 9 months treatment (p=0.0026) Tolerability findings Generally well-tolerated, with two possibly treatment-related serious adverse events Treatment-related adverse effects were transient and mainly mild (75.8%) to moderate (22.6%); consistent with those known to be associated with non-systemic corticosteroids No metabolic adverse events (hypertension, diabetes, weight gain) No severe infections June 2020 12#13Nefecon was generally well-tolerated in NEFIGAN Solicited GCS AES Overview of all AEs calliditas Summary of solicited steroid (GCS) adverse events 20% 22% 20% Placebo (n=50) Run-in 20% 41% 29% Nefecon 16 mg (n=49) Treatment Follow-up 39% 24% Nefecon 8 mg (n=51) Three most commonly reported adverse events: Nasopharyngitis, acne and joint swelling Intensity of adverse events in nefecon treated patients: mild (75.8%), moderate (22.6%) and severe (1.6%) All serious adverse events were determined to be unrelated to Nefecon, except for two possibly treatment-related serious adverse events - one patient who developed deep venous thrombosis and another with aggravation of a renal condition Solicited adverse event reporting A procedure where patients were asked specific questions at 14 times during the study - 12 typical GCS adverse events June 2020 13#14No clinically meaningful changes in blood pressure and body weight during Nefecon treatment Change from baseline in SBP (mm/Hg) Blood pressure ● No clinically meaningful changes from baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) D Placebo EoT follow-up Note: Data on file. calliditas NEFECON 8 mg EOT Last follow-up NEFECON 16 mg EDT follow-up Change from baseline in DBP (mm/Hg) 8 20 Placebo 8 follow-up NEFECON 8 mg EDT follow-up NEFECON 16 mg EST follow-up Change from baseline in body weight (kg) Body weight No clinically meaningful changes from baseline in body weight 10 -10 Placebo 9 . ET Last follow-up NEFECON 8 mg EOT Last follow-up NEFECON 16 mg EOT Last follow-up June 2020 14#15No clinically relevant change in HbA1c during Nefecon treatment Change in HbA1c from baseline to end of treatment End of treatment [mmol/mol) 20 calliditas Change in HbA1c 8 mg treatment group Baseline (mmol/mol) Note: HbA1c Measure of the risk for having diabetes. Data derived from post-hoc analyses. Data on file. End of treatment (mmol/mol) Change in HbA1c 16 mg treatment group Baseline (mmol/mol) June 2020 15#16Ongoing pivotal Phase 3 clinical trial (NeflgArd) designed to confirm Phase 2b results → Phase 3 study design evaluates the same primary endpoint as Phase 2b trial → Fixed 16 mg Nefecon once daily oral dose Phase 3 design - NeflgArd Screening Verify optimized & stable RAS blockade calliditas Bandom- Key highlights Part A 4Q 2020: Expected topline readout of 200 patients 2022: Expected readout on 360 patients → Reduction of proteinuria: Accelerated approval in U.S. and conditional approval in E.U. based on Part A data →Full approval on 2-year eGFR based endpoint - 360 patients Trial period 12 months | 9 months on treatment Nefecon 16 mg/day Placebo 3 months follow-up Optimized RAS inhibition Part B Standard long-term follow-up June 2020 16#17Phase 3 trial design & criteria Two-part trial design based on feedback from FDA and EMA: - Part A • N=200, two arms; 16mg Nefecon and placebo; global trial in 19 countries and approximately 150 sites • Primary endpoint: decrease in UPCR at 9 months (same as Phase 2b trial) • Fully recruited as of Dec. 2019 with topline results expected in 4Q 2020 Part B • N=360 (including Part A patients) • Primary endpoint: difference in kidney function between treated and placebo patients as measured by eGFR over a 2-year period. from dosing (same metric as Part A's secondary endpoint over a 1-yr period) . To confirm the long-term clinical benefit of observed proteinuria reduction and validate the surrogate marker Readout expected in 2022 after 360 patients have completed 2 years in the trial calliditas Inclusion criteria Biopsy-confirmed primary IgA Nephropathy (IgAN) ≥18 years Total urine protein > 1g/day (KDIGO guidelines) eGFR > 35 mL/min * 1.73m² and ≤ 90 ml/min * 1.73m² Stable RAS treatment for 3 months Exclusion criteria Secondary forms of IgAN TB Kidney transplanted patients Treatment with high dose corticosteroids or immunosuppressants in the past 12 months for the treatment of IgAN Main differences from Phase 2b Aligning to KDIGO guidelines - slightly more severe patients in phase 3 • Total urine protein from 20.75 g/day to 1g/day eGFR from > 45 to 235 and <90 mL/min/1.73m² June 2020 17#18COVID-19 business impact Phase 3 study continues to be on plan Over 146 clinical sites activated and recruiting across 19 countries Significant part of Q1 focused on analyzing potential impact of the virus across different geographic regions and putting mitigating solutions in place to ensure patient safety and trial integrity Limited impact to date on NeflgArd: Part A fully recruited in December 2019 Oral medication # ■ · ■ Limited interaction with healthcare system Successful implementation of strategy encompassing CRO, national coordinators and site staff to minimize potential impact Helpful guidance received from regulatory bodies. Part B of Phase 3 NefigArd trial: full recruitment still anticipated to be competed before end of 2020 based on recruited number of patients to date and recent increase in activities in China calliditas June 2020 18#19Nefecon - Potential to be first approved treatment for IgAN FPI Nov 2018 150 clinical sites recruiting in 19 countries 2018 2019 Fully recruited 200 patients for Part A of NefigArd (Dec. 21st, 2019) calliditas NeflgArd Part A readout expected in Q4 2020 2020 Expected filing for accelerated approval in U.S. and conditional approval in E.U. in 1H 2021 2021 Anticipated U.S. market launch in 2022 NeflgArd Part B readout in 2022 for full approval 2022 Expected filing of marketing applications in 1H 2021 for accelerated approval in U.S. and conditional approval in E.U., if data from Part A are positive Readout on the differential in loss of kidney function between placebo and treated over two years (eGFR) for validation of surrogate marker expected in 2022 June 2020 19#20Planned open-label extension and chronic dosing trials Open-label extension trial: For eligible patients who have completed treatment in Part A and Part B of NefigArd trial Expected to commence in 4Q 2020 when first patient has completed both Part A and Part B of NefigArd trial Open-label chronic dosing trial: Expect to commence in 2021 to provide safety and efficacy data for chronic treatment with Nefecon Leveraging existing sites and networks Inclusion criteria expected to be similar to those used in NeflgArd trial All patients enrolled will be on active treatment, starting with 16 mg once daily dose for 9 months of treatment followed by a maintenance dose - Duration of maintenance dose will be determined based on regulatory feedback Enables additional data capture related to safety and maintenance treatment . calliditas June 2020 20#21Calliditas' global commercialization Commercial strategy European partner Market positioning Market opportunity Independent U.S. commercialization / Partner ex-US strategy Target IgAN patients at risk of progressing to ESRD (up to 50%) Earlier-stage treatment to prevent progression and preserve kidney function Chronic / intermittent dosing Commercial Partner, existing distribution channels and / or complementary products Targeting of therapeutically focused nephrologists Collaborate with patient organizations Asia ex-Greater China & Singapore - Third party (IQVIA) research commissioned by the Company 2 Third party (IQVIA) research estimates applied to target population (50%) assuming bi-annual treatment calliditas Partner with leading organizations in each market ex-US Education of payors regarding disease and severe side effects of existing off-label treatments Specialist target market Potentially first approved on-label medication for IgAN, with disease modifying potential. Establish new standard of care for IgAN Orphan drug U.S. market opportunity of $9-10 billion; Europe & China other significant markets near term Up to 50% of diagnosed patients represent core target market Additional partnerships possible - significant unmet medical need June 2020 21#22IgAN in the U.S. - significant unmet medical need with considerable cost to society Market size and patient profile Total market opportunity of $9-10 billion in the U.S. alone Prevalence of 130,000 - 150,000 Normally presents when patient in their 20-30s More prevalent in men than in women Up to 50% at risk of developing ESRD within 10- 20 years ESRD cost to society Dialysis can cost between $70,000 and $200,000 per year, with a total estimated annual hemodialysis cost in the U.S. of $42 billion ¹.2 Kidney transplant average cost $414,800³ with a total estimated annual cost in the U.S. of $7 billion Source: 1) U.S. Renal Data System, USRDS 2013 Annual Data Report: Atlas of End-Stage Renal Disease in the United States, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2014. 2) Calliditas estimate based on interviews commissioned by the Company. 3) Milliman, Milliman research report:2017 U.S organ and tissue and transplant cost estimation and discussion. calliditas June 2020 22#23Market landscape research Overview of research coverage Qualitative interviews: 8 payers covering MCO, PBM, IDN, and FFS for organizations/plans covering over 225 million U.S. lives • 12 Nephrologists representing academic centers, community hospitals and private practices that treat a minimum of 10 IgAN patients per month Quantitative research/survey: 102 Nephrologists that, on average, treat 14 IgAN patients per month calliditas IMS Health & Quintiles are now IQVIA™ Nephrologist summary: perception of Nefecon Product profile shown to nephrologists mimicked the Phase 2b NEFIGAN trial results The majority of nephrologists indicated they would: Prescribe Nefecon for their IgAN patients within the first year of being on the market (68%) • Prescribe Nefecon as the first agent after, or in conjunction with, ACES/ARBS 90% of the nephrologists familiar with budesonide had a neutral or favorable opinion when learning the active ingredient in Nefecon was budesonide Assuming no tolerability issues, half of nephrologists indicated an interest in continuing use of Nefecon past its initial 9-month course June 2020 23#24Payor summary: perception of Nefecon Clinical results from Phase 2b were strong and supportive of seeking approval based on the surrogate marker Want to know what treatment to expect after the first 9 months, eager to see how long it might delay dialysis and/or transplant Didn't anticipate managing too differently - as long as the price remained within the broad range of $55 - 85k per year. Restrictions are standard to specialty products and include: • Prior authorization to label Prescribed by nephrologist Confirmation of IgAN diagnosis through renal biopsy Step to ACE/ARB • Tier 3 or 4 placement Opportunity to strengthen Nefecon's value proposition by leveraging: KOL guidance and endorsements Health-economic benefit related to cost effectiveness of Nefecon vs. cost of dialysis/kidney transplant • Additional clinical data related to the degree of sustained efficacy and tolerability post course of Nefecon calliditas June 2020 24#25IgAN nephrologist mapping research Community size of 3,748 nephrologists in the U.S. Entrenched leaders with strong consensus, information flows quickly through most of the network 200 KOLS (orange circles) have first degree connections with 90% of the entire community (blue circles) Sales force of approximately 40 representatives provides the reach and frequency coverage for U.S. market calliditas June 2020 25#26Commercialization strategy and market opportunity in the U.S. Significant unmet medical need Commercial strategy Positioning Pricing from research Market opportunity calliditas Independent U.S. commercialization Orphan Drug 130-150k prevalence with up to 50% at risk of developing ESRD within 10-20 years www. Third party IQVIA) research commissioned by the Company Severe side effects of existing off-label treatments Disease modifying potential by delaying or avoiding progression to dialysis / transplant Earlier stage treatment to preserve kidney function and prevent progression to dialysis/ transplant Chronic / intermittent dosing ✓ Disease modifying potential- delay or avoid dialysis / transplantation Targeting of therapeutically focused nephrologists - hub-and-spoke structure Collaborate with patient / advocacy organizations Relatively small sales (~40) and marketing organization Potentially first approved on-label treatment for IgAN with disease modifying potential. Establish a new standard of care for IgAN $55,000-85,000 per patient per treatment cycle¹ Total market of $9-10bn; up to 50% at risk of developing ESRD resulting in core target market of $4.5-5bn June 2020 26#27Opportunity for disease modifying treatment of autoimmune liver diseases Autoimmune liver diseases originate from the liver The autoimmune process is believed to be initiated by antigen-induced production of cytotoxic T-cells and B- cell derived auto-antibodies. In PBC, the cytotoxic T-cells and the auto-antibodies are directed towards antigens on the surface of the epithelial cells of the small bile ducts in the liver, resulting in inflammation and damage to the duct cells and eventually destroying the bile ducts¹. • The destruction of bile ducts result in an increase of bile to levels that are toxic to the liver cells, eventually resulting in liver impairment, cirrhosis and ESLD In AIH, the cytotoxic T-cells and auto-antibodies are directed towards antigens presented on the surface of the liver cells, leading to liver impairment, cirrhosis and eventually ESLD² Source: 1) Hirshfield, 2013, Annu Rev Pathol, 8:303-30 2) Monns, Journal of Hepatology 2015, 62.5100 5111 calliditas June 2020 27#28Primary Biliary Cholangitis The disease Primary Biliary Cholangitis (PBC) is a progressive and chronic autoimmune disease of the liver¹ Early symptoms include fatigue, itchy skin and dry eyes/mouth. Later stages - liver stiffness, musculoskeletal pain, edema, jaundice and underactive thyroid Estimated prevalence 140,000 Annual U.S. incidence 0.3-5.8 per 100,000 Standard of care Ursodeoxycholic acid (UDCA) and obeticholic acid (Ocaliva) are the only FDA-approved medical treatments for PBC² No targeted anti-inflammatory therapy is approved in the U.S. or Europe Previous trials indicates that corticosteroids may alleviate symptoms and improve biochemical and histologic findings³ Sou 1) Linder et tepalogy, 2009 5/11291-30 EASL PC Cinical Practice Guidelines, Journal of Hepatology 2017, 62 545-172 2) met Gastroterology 2000 129-1633-163) CASE PBC Cinca Practice Guenes, Journal of Hepatology 2017, 67 145-1724) Compony estimate based on prevence reported by Kim et al Gastroenterology 2000 1196 1631-6 and Nguyen et al, Best Pract Res Clin Gastroenterol 2010; 245.647-54 5) Nguyen et al, Best Pract Res Clin Gastroenterol 2010; 3415): 647-654 calliditas June 2020 28#29Autoimmune Hepatitis The disease Autoimmune Hepatitis (AIH) is a rare, orphan, chronic inflammation of the liver¹ Leads at variable rates to cirrhosis with complications such as portal hypertension, liver failure and liver cancer Typical symptoms are fatigue, abdominal discomfort, jaundice, enlarged liver, skin rashes, joint pains and, in women, loss of menstruation Estimated prevalence² 50-90% will relapse following cessation of treatment We estimate the intolerance to be 13-15% of the total population 50,000-80,000 Standard of care³ Currently no products approved in the U.S.; standard of care includes immunosuppression with systemic corticosteroids (prednisone) alone or in combination with azathioprine Annual U.S. incidence 0.1-1.9 per 100,000 Up to 80% of treated patients report steroid related side effects after 2 years and 15% discontinue due to drug- related adverse events calliditas Source: 1) Feld et al, Hepatology 2005:42:53-62, Sahebjam and Vierling, Front Med. 2015 Jun (2) 187-219. 2) Sahebjam and Vierling, Front Med 2015; 9(2):187-219.3) Czaja, Expert Opin Drug Sal. 2008 7(3):319-33; Czaja, Liver Ins 2009-29(6):816-23; Manns et al, Hepatology 2010;51(6):2193-213 (AASLD 2010 AIH Guideline). June 2020 29#30Rationale and next steps Plan to rapidly develop and seek approval and commercialize in U.S. • AIH PBC Creates optionality and flexibility for product portfolio in the U.S. Orphan indication with market exclusivity and reimbursement • No approved treatments in the U.S. calliditas ■ • Differentiated approach targeting reduction in both inflammation and origin of auto immune response Preparation for FDA interaction initiated • FDA interaction targeted for 2020 for AIH and 1Q 2021 for PBC June 2020 30#31Anticipated milestones " 1H 2018 IPO raising $82m on Nasdaq OMX Anticipated milestones regarding Calliditas' clinical, regulatory and commercial plans 2H 2018 NefigArd first patient in * Application for Orphan Drug Designation (ODD) for PBC submitted * Application for ODD for AIH submitted # H 1H 2019 Filing of Pediatric Investigational Plan submitted to EMA Approval of ODD designation for PBC • Approval of ODD designation for AIH * Subject to uncertainty due to COVID-19 outbreak. calliditas 2H 2019 * EMA meeting to discuss surrogate marker = Fully recruited Part A of NefigArd with 200 patients - China IND approval for Nefecon in IgAN, I triggering $5mm milestone * EMA positive opinion regarding pediatric pathway for Nefecon in IgAN * Topline readout of Part A of NefigArd for 200 patients (40 2020) I • Initiate open-label extension trial I for Nefecon in IgAN (4Q 2020) ■ 2020* ■ ⠀ Complete recruitment of Part B of NeflgArd trial of additional 160 patients (2020) FDA meeting regarding development plans for AIH (2020) China part of phase 3 recruitment initiated (2020) * In-licensing of a new project to the pipeline (2020) 2021 • FDA meeting regarding development plans for PBC (1Q 2021) +NDA / MAA filings with FDA and EMA for accelerated/ conditional approval of Nefecon in IgAN (1H 2021) * Initiate open-label chronic dosing trial for Nefecon in IgAN (2021) * Late stage clinical program initiated 2022 Commercial launch of Nefecon for IgAN in U.S. (1H 2022) * Readout of Part B of NefigArd trial based on 360 patients for validation of surrogate marker to support full approval (2022)" June 2020 31#32Investment highlights 1 Nefecon is a proprietary, novel treatment for IgAN intended to be disease modifying Nefecon targets the presumed origin of the disease - the area of the ileum where the highest concentration of Peyer's patches are located 2 3 4 5 6 7 Nefecon is the most advanced product candidate for IgAN. The only successful randomized, double-blind, placebo-controlled Phase 2b clinical trial carried out in IgAN to date Ongoing pivotal Phase 3 clinical trial (NeflgArd) using the same primary endpoint as previous successful Phase 2b trial Regulatory pathway based on FDA and EMA acceptance of accelerated / conditional approval based on proteinuria as surrogate marker for IgAN Significant unmet medical need in IgAN with no currently approved treatments; total market opportunity of US$9-10bn in the U.S alone. Additional potential for pipeline development and in-licensing of product candidates targeting orphan diseases calliditas 410 300 1600 200 n 100 June 2020 32#33Appendix calliditas calliditas THERAPEUTICS June 2020 33#34Proteinuria surrogate endpoint evaluation Trial Level Analysis, published by Inker et al, 2016 Establish correlation between proteinuria and risk for ESRD Treatment effect on clinical outcome 2.72 calliditas 0.65 1.00 0.37- 0.22 0.14 0.08 0.05 0.30 A OAD SINA VA 40 40 V v 0.55 1 Treatment effect on proteinuria Locatelli MINIF R²=0.90 (0.47-1.0) Slope = 2.15 (0.10 -4.23) P2B = 29% reduction in proteinuria → 65% reduction in risk of ESRD → 32% upper 97.5% confidence limit *Clinical Outcome (ESRD) doubling of serum creatinine, need for dialysis, kidney transplant or death due to kidney disease ** 16 mg NEFECON dose group vs Placebo dose group June 2020 34#35Consistent trends support selection of 16 mg versus 8 mg NEFIGAN trial. calliditas UPCR (interim) Total 24-hour urine protein Urinary albumin creatinine ratio Total 24-hour urine albumin P-Creatinine Microhematuria proportion Placebo 3% 1% 86% 9 Months Nefecon (16 mg) (27%) (30%) (28%) (33%) (2%) 63% Nefecon (8 mg) (22%) (20%) (14%) (18%) (1%) 82% We selected 16mg dose for evaluation in our pivotal Phase 3 clinical trial June 2020 35#36Manufacturing calliditas Calliditas works with pharmaceutical service providers Calliditas has since 2011 used one of the world's largest contract development and manufacturing organizations (CDMOs) for both product development activities and manufacturing of clinical study materials Clinical packaging, labeling and distribution for Phase 3 will be performed by a contract manufacturing organization (CMO) specialized in clinical study supply In parallel to planning and set up of manufacturing activities, the CDMO will perform a complete validation of analytical procedures for the testing and release of clinical study materials for Phase 3 Significant novel know-how of the composition, manufacturing process and the drug release performance of Nefecon, gained through the extensive product development work June 2020 36#37Board of directors ELMAR SCHNEE Chairman Selected experience: Previously CEO of Merck Serono and 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 held several senior global management positions with UCB and Sanofi BENGT JULANDER Board member Selected experience: Member of the Boards of Bringwell, Linc, Livland Skog, Medivir, Proequo, Sedana Medical, Stille and Swevet, and a number of smaller companies calliditas HILDE FURBERG Board member Selected experience: Currently Senior VP of Rare Disease EMEA at Sanofi Genzyme and Non-executive Director at BerGenBio. Previously, held board memberships at Algeta, Clavis Pharma and Probi DIANE PARKS Board member Selected experience: Deep sales and marketing experience from the US; has held positions such as Head of U.S. Commercial for Kite Pharma, VP of Sales for Amgen and Head of Global Marketing at Pharmacyclics LENNART HANSSON Board member Selected experience: Currently Senior Advisor at industrifonden. Previously executive positions at KabiGen, Symbicom, AstraZeneca and Biovitrum THOMAS EKLUND Board member Selected experience: Chairman of the Board of Moberg Pharma and Itrim. Board member of multiple companies incl. Boule Diagnostics and Biotage. Senior positions at Investor Growth Capital, Alfred Berg and Handelsbanken June 2020 37#38Clinical advisory board comprising world leading IgAN specialists Prof Jonathan Barratt Nephrologist Leicester University, UK SELECTED EXPERIENCE: . On the steering committee of the International IgA Nephropathy Network • Involved in many clinical trials involving IgA Nephropathy Prof Bengt Fellström Nephrologist Akademiska sjukhuset. Sweden SELECTED EXPERIENCE: • Senior professor at Department of Medical Sciences • Inventor of Nefecon calliditas Global Advisory Board Prof Brad Rovin Nephrologist Ohio State University, USA SELECTED EXPERIENCE: • Experienced nephrologist working closely with Calliditas • Focused on biomarker development for glomerular diseases Prof Jürgen Floege Nephrologist Aachen University, Germany SELECTED EXPERIENCE: • Executive council member International Society of Nephrology and scientific advisory board of ERA/EDTA • Responsible for the STOP-IGAN study Prof Richard Lafayette Nephrologist Stanford University, USA SELECTED EXPERIENCE: Editor-in-Chief of ASN Kidney News • Member of the Glomerular Disease Advisory Committee, ASN Dr Hernan Trimarchi Nephrologist Universidad de Buenos Aires, Argentina SELECTED EXPERIENCE: • Experienced nephrologist • Part of the global IgAN steering committee Prof Daniel Cattran Nephrologist University of Toronto, Canada SELECTED EXPERIENCE: • Kidney Foundation of Canada, PSI, the National Institutes of Health and the Canadian Institutes for Health Research Prof Vladimir Tesar Nephrologist Charles University in Prague, Czech Republic SELECTED EXPERIENCE: Scientific Advisory Board of ERA/EDTA and ASN • Was responsible for the VALIGA study Prof Hong Zhang Nephrologist Peking University First Hospital, Beijing SELECTED EXPERIENCE: • Experienced nephrologist with many board committee positions in China calliditas THERAPEUTICS Broad support from key opinion leaders underpin global development program June 2020 38

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