Treating Metabolic Acidosis and Slowing the Progression of Chronic Kidney Disease Investor Presentation April 2020
Forward Looking Statements Any statements contained in this presentation or made during the accompanying oral presentation that are not statements of historical facts are forward-looking statements as defined under the Federal securities laws. Examples of such statements include our plans, beliefs, intentions, expectations and projections regarding, among other things: (i) our receipt of FDA approval for veverimer on a timely basis, or at all; (ii) the potential date of approval of our New Drug Application (“NDA”) for veverimer; (iii) advisory committee meeting matters; (iv) the safety, efficacy and other expected patient benefits of veverimer; (v) the market opportunity, competition and rate of adoption for veverimer; (vi) our future clinical trial and product development milestones; (vii) our disease awareness and commercialization efforts and strategies; (viii) our receipt of adequate reimbursement for veverimer, and (ix) our financial projections and cost estimates. Any such forward-looking statements are based on our current expectations and assumptions, but are subject to a number of risks and uncertainties that could cause our actual future results to differ materially from our current expectations or those implied by the forward-looking statements. In addition, this presentation contains industry and market data prepared by third parties or by us. We have not independently verified this third-party data, and our data is based on our estimates and assumptions, which are subject to uncertainty and risk. As a result, you should not place undue reliance on this industry and market data. The risks and uncertainties that could adversely affect our forward-looking statements and the industry and market data include, but are not limited to: (i) the prospects of veverimer, including our ability to obtain FDA approval; (ii) the potential that the FDA could identify issues regarding our NDA at any time during its review of the application; (iii) risks related to the enrollment, completion and results of our confirmatory postmarketing trial; (iv) risk related to the market acceptance or commercial success of veverimer, including receipt of adequate reimbursement; (v) risks related to competition, potential market size and the size of the patient population for veverimer; (vi) risks related to the safety, efficacy and clinical benefit of veverimer; (vii) risks related to our manufacturing, sales, marketing and distribution strategies and activities; (viii) our medical affairs activities; (ix) risks related to COVID-19; and (ix) risks related to our capital requirements and ability to raise sufficient funds for our operations. These and other factors that may affect our future results and operations are identified and described in more detail in our filings with the Securities and Exchange Commission (the “SEC”), including the Company’s most recent Annual Report filed on Form 10-K and our subsequently filed Quarterly Report(s) on Form 10-Q. You should not place undue reliance on these forward-looking statements, which speak only as of the date of this presentation. Except as required by applicable law, the Company does not intend to update any of the forward-looking statements to conform these statements to actual results, later events or circumstances or to reflect the occurrence of unanticipated events. 2
Our Goals for Veverimer* A Drug Candidate for the Treatment of Metabolic Acidosis in Patients with CKD Veverimer Is Under Review by the FDA with a PDUFA Goal Date of August 22, 2020 First and ONLY Disease Improve How Patients FDA-Approved Therapy Modifying Feel and Function Significant unmet medical Slow CKD progression Enhance physical need to treat chronic through the treatment of functioning and physical metabolic acidosis chronic metabolic acidosis functioning-related quality of life * Veverimer is not yet approved 3
1. Metabolic Acidosis is Commonly Caused by Kidney Disease Diseased Kidneys Lose Capacity to Excrete Acid Serum Bicarbonate Levels Fall acid Normal 22 – 29 Range mEq/L Serum bicarbonate Acid is generated Diseased kidneys An increase in acid Metabolic 12 – <22 from dietary sources lose capacity leads to a decrease Acidosis mEq/L and daily metabolism to excrete in serum bicarbonate excess acid and a vicious cycle leading to worsening metabolic acidosis Acute/Severe <12 Metabolic mEq/L Acidosis Source: Kraut. Nat Rev Nephrol. 2010;6(5):274; KDIGO Clinical Practice Guidelines 2012. 5
2. Metabolic Acidosis is Highly Prevalent in CKD ~ 3 Million Patients with Metabolic Acidosis and CKD in the United States ~600,000 ~1.1 Million > % ~1.4 Million 30 18% 9% Stage 3a Stage 3b Stage 4 & 5 *Stage 5 pre-dialysis patients. Data on file. NHANES 1999-2004 reports prevalence of CKD Stages 3 and 4 for the US adult population ages 20 and older. CKD Stage 3 and 4 prevalence was calculated using NHANES prevalence and 2016 US Census data. Stage 3a (70%) and 3b (30%) were approximated using NCCD-CDC Surveillance System. Metabolic acidosis prevalence by Stage 3a, 3b, and 4 reported in Inker LA et al., JASN, 2011. 6
3. Metabolic Acidosis Can Impact Kidney, Bone and Muscle Health Metabolic Acidosis is Associated with an Increased Risk of CKD Progression and Adverse Effects On Bone and Muscle Reduced Renal Acid Secretion Increased Risk of CKD Leads to Acid Buildup Progression and Mortality Acid Buffering Leads to Loss Increased Risk of Fractures, of Bone Density Renal Osteodystrophy Acid Buffering Leads to Muscle Wasting and Reduced Increased Protein Catabolism Physical Functioning Kraut JA et al., Adv Chronic Kidney Dis, 2017. 7
4. Metabolic Acidosis is Linked to Worsening Kidney Disease Increased Acid Excretion Augmented ammoniagenesis and enhanced proton secretion Renal Impairment Metabolic Persistent Acid Retention Kidney disease Sustained expression of ET-1, Acidosis progression aldosterone and angiotensin II Further Diminishing Kidney Function Kidney fibrosis, proteinuria, inflammation, sodium and water retention Laghmani K et al., J Clin Invest, 2001. Wesson DE, JASN, 2001. Wesson DE et al., KI, 2010. Wesson DE et al., KI, 2012. Wesson DE et al., Nephrol Dial Transplant, 2015. Phisitkul S et al., KI, 2010. Ruiz-Ortega M et al., J Hypertens Suppl, 1994. Seccia TM et al., J Hypertens, 2008. Wolf G et al., Nephron Physiol, 2003. Greene EL et al., J Clin Invest, 1996. Remuzzi G 8 et al., Kidney Blood Press Res, 1996. Halperin ML et al., Am J Kidney Dis, 1989. Nath KA et al., J Clin Invest, 1985. Nath KA et al., AJKD, 1991. Chen W et al., BMC Nephrol, 2014.
5. Multiple Academic Studies Show that Increasing Serum Bicarbonate Translates to Clinical Benefit Forest Plot Shows Slower Decline in eGFR at the End of Study Period with Oral Alkali Supplementation or Reduction of Dietary Acid Intake Oral alkali Dietary intervention Navaneethan et al., CJASN, 2019. 9
6. National and International Kidney Disease Guidelines Recommend Treating Metabolic Acidosis CKD Practice Guidelines Suggest Treatment if Serum Bicarbonate Levels are Below 22 mEq/L “We suggest that in people with CKD and “In CKD Stages 3, 4, and 5, the serum level serum bicarbonate concentrations of total CO2 should be measured. The <22 mmol/L treatment with oral bicarbonate frequency of these measurements should be supplementation be given to maintain serum based on the stage of CKD (OPINION). bicarbonate within the normal range, unless contraindicated. In these patients, serum levels of total CO2 should be maintained at >22 mEq/L Serum bicarbonate concentrations less than (22 mmol/L). (EVIDENCE) If necessary, 22 mmol/L are associated with risk of CKD supplemental alkali salts should be given to progression and increased risk of death.” achieve this goal. (OPINION).” KDIGO: Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. Kidney Inter, Suppl, 2013. Eknoyan G et al., AJKD, 2003. 10
7. Metabolic Acidosis is Undertreated The Majority of Patients with Metabolic 100% Acidosis are NOT treated 90% 80% % of 70% Patients 60% Receiving 50% Oral Alkali 40% Therapy 30% 20% 15% < 10% 10% < 3% < 6% 0% CRIC Study Tangri 2020 TRCA-301 Tangri 2019 Dobre 2013 Dobre M et al., AJKD, 2013. Tangri N et al., NKF SCM, 2020. Wesson DE et al., The Lancet, 2019. Tangri N et al., ASN, 2019. The Tangri studies were sponsored by Tricida, Inc. 11
8. Current Treatments for Metabolic Acidosis Have Limitations: Oral Alkali Supplements Can Deliver Unacceptable Sodium Loads KDIGO guidelines recommend restricting sodium intake to <2 g per day in patients with CKD Other guidelines for common co-morbid diseases associated with CKD also recommend restricting dietary sodium Heart Failure (ACCF/AHA) Hypertension (ACC/AHA) Diabetes (ADA) <1.5 g of sodium per day (stage A/B) <1.5 g of sodium per day (optimal goal) <2.3 g of sodium per day <3 g of sodium per day (stage C/D) Sodium Loads Delivered by Daily Oral Alkali Dosing* Baseline Serum Bicarbonate Increase Needed to Normalize Serum Corresponding Oral NaHCO Dose (g/day) (mEq/L) Bicarbonate (mEq/L) 3 Sodium Dose 12 10 20.4 5.6 g/day 18 4 8.1 2.2 g/day *Calculation represents an 80 kg person. ACC, American College of Cardiology; ACCF, American College of Cardiology Foundation; ADA, American Diabetes Association; AHA, American Heart Association. Abramowitz, et al. CJASN, 2013. 12
8. Current Treatments for Metabolic Acidosis Have Limitations: Oral Alkali Supplements Can Have Adverse Systemic Effects Adverse Systemic Effects Mean Changes (Day 1 to Day 5) in Weight and Systolic Blood Pressure • The volume effects (e.g., blood pressure, sodium retention) of Change in Body Change in Systolic Weight Blood Pressure NaHCO3 are the same as those from Change ofin body weight Change ofin systolic blood pressure NaCl 5 24 20 4 • Worsening edema/increased loop 16 3 diuretics required 12 Pound 2 mm Hg • Worsening hypertension/increased 8 1 4 antihypertensive drugs required 0 0 NaCl (200 mEq) NaHCO3 (100 mEq) NaCl (200 mEq) NaHCO3 (100 mEq) • Gastrointestinal intolerability + + NaCl (100 mEq) NaCl (100 mEq) Husted et al., Clinical Nephrology, 1977. Navaneethan SD et al., CJASN, 2019. 13
8. Current Treatments for Metabolic Acidosis Have Limitations Sodium from Oral Alkali May Inhibit the Efficacy of Common Hypertension Therapies Sodium Attenuates the Beneficial Effects of ARBs and ACEi ACEi therapy Post-hoc analysis of RENAAL and IDNT trials Post-Hoc Analysis of REIN Trials Risk of kidney events in patients receiving ARBs increases in Higher salt intake was associated with an increased risk of direct proportion to higher sodium intake progression to ESRD in patients taking an ACEi Post-hoc Analysis of RENAAL and IDNT Studies: “The renal and cardiovascular protective effects of ARB therapy compared with non-RAASi–based therapy attenuated in subjects with larger consumption of sodium so that in subjects with the highest sodium intake the treatment effects on hard renal and cardiovascular outcomes were completely annihilated.” ARB: Angiotension II receptor blocker. ACE: Angiotension converting enzyme inhibitor. RAASi: Renal angiotension aldosterone system inhibitor. Lambers Heerspink HJ et al., KI, 2012. Vegter S et al., JASN, 2012. 14
8. Current Treatments for Metabolic Acidosis Have Limitations: Oral Alkali Supplements Have Not Been Established to be Safe and Efficacious (Not FDA-Approved) BiCARB Multi-Center, Double-Blind, Placebo Controlled, Randomized Trial • Efficacy Summary • Population: 300 subjects enrolled at 27 study sites in － There is no evidence of a treatment benefit of oral the UK sodium bicarbonate at doses of 1.5 – 3 g/day vs • Double-blind, placebo-controlled 24-month study placebo on physical function, quality of life or CKD progression • Average Age: ~74 years • Baseline Serum Bicarbonate: ~20-21 mEq/L • Safety Summary － Cardiac disorders • Baseline eGFR: ~18-20 mL/min/1.73m2 • 21% sodium bicarbonate vs 13% placebo • Restrictive eligibility criteria, and corresponding restrictive － Death population, resulted in 4 years to enroll 300 subjects, of • 9.9% sodium bicarbonate vs 7.4% placebo which only about half completed the study － Early withdrawals • 47% sodium bicarbonate vs 46% placebo “Our results suggest that at least for patients aged 60 and over with CKD GFR categories 4 and 5, 1.5 to 3 g per day of oral bicarbonate does not produce any health benefits and may be associated with net harms.” Conclusion from The BiCARB study group The BiCARB study group, BMC Medicine, 2020. 15
Metabolic Acidosis: Three Key Takeaways Metabolic acidosis is common, harmful 1 and needs to be treated Metabolic acidosis is both a complication and an underlying cause of kidney disease 2 progression There is an urgent need for an FDA-approved 3 therapy to treat chronic metabolic acidosis 16
There is an Urgent Need for an FDA-Approved Therapy to Treat Chronic Metabolic Acidosis Currently Available Approaches Have Limitations and Are Not Widely Used • Neutralize acid with oral alkali supplements • Decrease acid intake with dietary intervention Veverimer: A Potential New Approach to Treat Metabolic Acidosis • Bind and remove intestinal acid with an orally administered, non-absorbed polymer – Does not introduce a sodium load – Analogous to mechanism healthy kidney uses when it excretes ammonium chloride and titratable acids to maintain acid/base balance – Results in an increase in serum bicarbonate 17
Veverimer: Designed to Bind and Remove Acid in the GI Tract to Raise Serum Bicarbonate and Treat Metabolic Acidosis 18
Veverimer: Designed to Bind and Remove HCl with High Capacity and Selectivity High Binding Capacity High Binding Selectivity NH2 NH2 veverimer Non-absorbed polymer GI Anions Ranked by Size NH2 NH2 Oral Ingestion Oral H+ Bile Acids NH + NH + + Fatty Acids 3 3 Binds protons (H ) and then selectively veverimer binds chloride (Cl–) Citrate veverimer + + NH3 NH3 in the GI tract Phosphate Cl- Chloride Cl- Cl- + + NH3 NH3 Excreted, resulting in veverimer The high degree of crosslinking in veverimer provides a removal of HCl* Acid Tract GI in Binding Acid that leads to high selectivity + + size exclusion mechanism NH3 NH3 Cl- Cl- for binding chloride (the smallest anion) over larger anions Excretion in Feces GI: Gastrointestinal. HCl: Hydrochloric acid. *Veverimer’s maximum theoretical HCl binding capacity is approximately 10 mEq/gram. 19
Veverimer: Ease of Administration* Once-a-day dosing Orally administered as a suspension in water 3 g, 6 g or 9 g dose sizes 2 oz. Water No observed drug-drug interactions** *Targeted profile if approved ** Data on file 20
Veverimer: Being Reviewed through the Accelerated Approval Program – PDUFA Goal Date of August 22, 2020 Accelerated Approval Veverimer NDA Accepted for Review Program Requirements through the Accelerated Approval Program Increasing blood bicarbonate may Treats a Serious, slow progression to ESRD for patients Life-Threatening Condition with CKD and metabolic acidosis Meaningful Advantage There are no FDA-approved therapies for Over Standard of Care the treatment of chronic metabolic acidosis Surrogate Endpoint Reasonably Increasing blood bicarbonate has been Likely to Predict Clinical Benefit linked to the slowing of CKD progression Source: FDA Guidance for Industry—Expedited Programs for Serious Conditions—Drugs and Biologics. 21
Veverimer: Clinical Trial Program Completed Clinical Trials Postmarketing Trial TRCA-101* Successful 2-week, randomized, double-blind, Initiated enrollment in 4Q 2018 placebo-controlled Phase 1/2 trial, 3 doses and 2 dosing regimens of veverimer or placebo Evaluate the efficacy and safety of veverimer in delaying CKD Blood bicarbonate endpoint progression in pre-dialysis patients with metabolic acidosis 135 subjects Anticipate randomizing ~1,600 subjects TRCA-301** Successful 12-week, randomized, double-blind, placebo-controlled Phase 3 trial Time to event trial: randomized, double-blind, placebo-controlled 3 – 9 g veverimer or placebo study Blood bicarbonate endpoint 217 subjects Protocol specifies an interim analysis when at least half the planned number of primary endpoint events have been accrued TRCA-301E*** Successful 40-week, blinded Phase 3 extension trial 3 – 9 g veverimer or placebo 196 subjects * Completed planned trials for NDA and published Data readout expected post initial approval TRCA-101, TRCA-301 & TRCA-301E results * Bushinsky et al., CJASN. 2018;13:26-35. **Wesson, et al., The Lancet, 2019. ***Wesson, et al., The Lancet, 2019. 22
Veverimer: TRCA-301 and TRCA-301E Trial Results Published in The Lancet TRCA-301 Results TRCA-301E Results 23
Veverimer: TRCA-301/301E Trial Design Study TRCA-301 Study TRCA-301E Treatment Period Treatment Period Veverimer 6 g QD (n=124) Veverimer 3-9 g QD (n=114) Fixed 6 g QD until Week 4 217 patients with eGFR 20-40 2 mL/min/1.73m R Dose adjustments Safety and serum 4:3 allowed * Follow-up bicarbonate 12-20 mEq/L Placebo QD (n=93) Placebo QD (n=82) Week -2 Day 1 Week 4 Week 12 Week 52 Week 54 R: randomization; QD: once daily. *Blinded dose adjustments (3 g, 6 g and 9 g QD veverimer) thereafter to maintain serum bicarbonate levels within the normal range. 24
Veverimer: TRCA-301: Baseline Disease Characteristics Veverimer Placebo Medication Veverimer Placebo N=124 N=93 Use N=124 N=93 29 28 ACE inhibitors / ARBs 67% 82% Baseline eGFR, mean mL/min/1.73m2 mL/min/1.73m2 Diuretics 60% 63% Baseline serum 17 mEq/L 17 mEq/L bicarbonate, mean Calcium channel blockers 56% 60% Selected Medical History Anti-diabetic drugs 53% 56% CKD 100% 100% Beta blockers 46% 53% Hypertension 97% 97% Lipid modifying agents 44% 53% Diabetes 61% 70% Anti-thrombotic agents 38% 48% Left ventricular hypertrophy 47% 41% Drugs for acid related disorders 10% 6% Congestive heart failure 29% 33% Sodium bicarbonate 10% 8% 25
Veverimer: Summary of TRCA-301/301E Clinical Trial Results TRCA-301 Veverimer-Treated Subjects Experienced a Mean TRCA-301 / TRCA-301E Increase from Baseline in Serum Bicarbonate of 4.5 mEq/L Prespecified Time-to-Event Analyses (52 Weeks) 21.7 65% Reduction in the Annualized Event Rate for Veverimer-Treated Subjects 22 21.6 21.6 22.0 21.7 4% DD50 21 incidence rate 20.8 4.5 mEq/L 20 20.2 (P< 0.0001) 12% DD50 0 0 incidence rate 19 19.0 18.6 18.6 18.9 18.4 18.5 18 18.1 17.3 17.3 17 BL Week 1 Week 2 Week 4 Week 6 Week 8 Week Week Placebo Veverimer 10 12 TRCA-301 / TRCA-301E TRCA-301 / TRCA-301E KDQOL Physical Function Domain Repeated Chair Stand Test Improved physical function physical Improved 11.4 function physical Improved -1.4 0 -4.3 -0.7 0 12 Time since randomisation (weeks) 40 52 BL: Baseline. W: Week. Error bars: Standard error of the mean. DD50: Death, dialysis or ≥50% reduction in eGFR. Wesson DE et al., Lancet 2019; 393:1417-27. Wesson DE et al., Lancet 2019; 394: 396-406. 26
Veverimer: TRCA-301E Prespecified Analyses 1) Kidney Disease Quality of Life (KDQOL) Physical Function Survey ̶ A validated questionnaire designed to assess kidney disease-specific health-related quality of life ̶ Subjects responded to the 10 KDQOL questions related to physical function during daily activities ̶ Total possible score = 100 2) Repeated Chair Stand Test ̶ Used as a measure of lower extremity muscle strength ̶ Measured as time for subject to complete 5 repetitions of sit-to-stand 3) Time to DD50 ̶ Evaluated time to death, dialysis/renal replacement therapy or ≥ 50% reduction in eGFR 27
Veverimer: Improvement in Patient-Reported Physical Function Over One Year (KDQOL Physical Function Domain) 15 p<0.0001 Veverimer (N=114) Placebo (N=82) 11.42*11.42 Mean 10 p=0.0396 p=0.0177 Change 7.80 from 6.49 Baseline in KDQOL 5 Physcial Function Domain 2.11 0 1.16 Functioning Physical Improved -0.71-0.7 Baseline: PBO = 55.73; Veverimer = 52.59 -5 0 4 8 12 16 20 24 28 32 36 40 46 52 Week *The minimally clinically important difference in KDQOL subscales, based on the academic literature, is 3 to 5 points Wesson et al., The Lancet, 2019. 28
Veverimer: Improvement in Measured Physical Functioning Over One Year (Repeated Chair Stand Test) 2 Veverimer (N=114) Placebo (N=82) 1 ImprovedPhysical Functioning 0 p=0.0017 p<0.0001 p<0.0001 Mean -1 -1.25 -1.19 Change --1.41.42 from -2 Baseline to -2.25 Complete -3 Repeated Chair Test, -4 -3.71 Seconds -4.28 -5 -4.28* Baseline: PBO = 21.01; Veverimer = 21.65 -6 0 4 8 12 16 20 24 28 32 36 40 46 52 Week *The minimally clinically important difference in the time to complete the repeated chair stand test, based on the academic literature, is 1.7 seconds Wesson et al., The Lancet, 2019. 29
Veverimer: Reduction in a Composite of Mortality and Kidney Disease Progression Over One Year (DD50) TRCA-301 / TRCA-301E Study Results Pre-Specified Time-to-Event Analyses (52 Weeks) Kaplan-Meier Plot of Time to First Occurrence of Death, Renal Replacement Therapy or ≥50% Decline in eGFR 4% DD50 incidence rate 65% Reduction 12% DD50 incidence rate DD50 = Death, dialysis/renal transplant or 50% reduction in eGFR. Incidence rate is calculated as 100 × number of events / total person-years. 30 Wesson et al., The Lancet, 2019.
Veverimer: TRCA-301/301E Safety Summary TRCA-301 TRCA-301E Veverimer Placebo Veverimer Placebo (n=124) (n=93) (n=114) (n=82) Discontinued prematurely 4.0% 4.3% 2.6% 9.8% Serious adverse events (none assessed to be related to 2.4% 2.2% 1.8% 4.9% study drug) Gastrointestinal adverse events 16.9% 8.6% 21.4% 25.9% Wesson et al., The Lancet, 2019. 31
Our Goal is to Launch Veverimer in the United States for Treatment of Patients with CKD and Metabolic Acidosis Treated by Nephrologists 32
Metabolic Acidosis is a Significant US Market Opportunity 3,000,000 Increased Awareness Patients with CKD and drives higher metabolic acidosis diagnosis and treatment Metabolic Acidosis Expansion 1,100,000 beyond nephrologists provides additional opportunity Patients Under Physician Care Focus on patients seen by nephrologists provides ~600,000 Patients Under initial opportunity for veverimer Nephrologist Care Data on file. NHANES 1999-2004 reports prevalence of CKD Stages 3 and 4 for the US adult population ages 20 and older. CKD Stage 3 and 4 prevalence was calculated using NHANES prevalence and 2016 US Census data. Stage 3a (70%) and 3b (30%) were approximated using NCCD-CDC Surveillance System. Metabolic acidosis prevalence by Stage 3a, 3b, and 4 reported in Inker LA et al., JASN, 2011. Symphony Health Solutions Claims Data. 33
A High Number of Patients with Metabolic Acidosis Are Treated By a Relatively Small Number of Nephrologists Highly Concentrated Market 100% 80% of Potential Target Patient Population 80% 60% 40% 20% Cumulative % Potential 0% ~5,000 Nephrologists Cumulative % of nephrologists with highest number of pre-dialysis patients with Stages 3-5 CKD Symphony Health Solutions IDV® 34
We Will Target ~5,000 Community Nephrologists at Launch Optimize Reach with 2 Regional Managers, 10 Division Heads and 80 to 85 Strategic Account Managers # Nephrologist Symphony Health Solutions IDV® 35
High-Prescribing Nephrologists Believe There is a Link Between Metabolic Acidosis and Kidney, Bone and Muscle Health Progression of CKD Muscle health Bone health 84% of respondents believe that 86% of respondents believe that 98% of respondents believe that treating metabolic acidosis helps to treating metabolic acidosis helps treating metabolic acidosis helps slow kidney disease progression maintain muscle health maintain bone health 84% 86% 98% Believe Believe Believe Also, 90% of respondents believe that a potential new treatment for metabolic acidosis that leads to improvements in physical function-related quality of life would be meaningful for their patients Tricida Primary Market Research, SciMedica Group, Aug 2018. Nephrologist n=50 36
Expanding our Disease Awareness Campaign Website and Neph+ App Digital Ads and Congresses Social Media Engagement ASN Kidney Week 2019 >1,000 Engagements with HCPs www.metabolicacidosisinsights.com Now ranked 1st on Google search 37
Increasing Awareness of Veverimer and Metabolic Acidosis Through Publications and Posters Veverimer Metabolic Acidosis TRCA-301 Results TRCA-301E Results March 2019 June 2019 Jun 2019: Tolerance to Mar 2019: Clinical Jul 2019: Effects of Veverimer versus placebo in Long-term safety and efficacy of Sodium in Patients With evidence that treatment Treatment of Metabolic patients with metabolic acidosis veverimer in patients with metabolic CKD-Induced Metabolic of metabolic acidosis Acidosis in CKD, A associated with chronic kidney acidosis in chronic kidney disease: a Acidosis: Does the slows the progression of Systematic Review and disease: a multicentre, multicentre, randomised, blinded, Accompanying Anion Matter? chronic kidney disease Meta-Analysis randomised, double-blind, placebo-controlled, 40-week controlled, phase 3 trial extension • Randomized Controlled Trial of • MOA and Onset of Effect of Veverimer, a • Metabolic Acidosis is an Independent • Metabolic acidosis is a Predictive Factor for All- Long-Term Safety and Efficacy Novel Acid Binder for the Treatment of MA Predictor of Adverse Renal Outcomes Cause Mortality in CKD* of Veverimer for Treatment of Associated with CKD and Higher Costs in Patients with • Metabolic acidosis is Undertreated in CKD Metabolic Acidosis Chronic Kidney Disease • Effects of Veverimer on Serum Bicarbonate • Understanding the Long-Term Impact of • Mechanism of Action of and Physical Function in Patients with • Metabolic Acidosis is Underdiagnosed Metabolic acidosis in CKD: Design of the Veverimer, a First-in-Class, Diabetes and CKD: Subgroup Analysis and Undertreated in Patients with ULTIMA-CKD Registry Orally-Administered, Non- from a Randomized Trial Chronic Kidney Disease Absorbed, Counterion-Free • Metabolic Acidosis is Associated with • Effects of Veverimer on Serum Bicarbonate Hydrochloric Acid Binder Being Failure to Thrive and Fractures/Falls in and Physical Function in Patients with CHF Developed for the Treatment of Patients with Chronic Kidney Disease and CKD: Subgroup Analysis from a Metabolic Acidosis in CKD • Association of Metabolic Acidosis with Randomized Trial • Adverse Clinical Outcomes in Patients with Adverse Cardiovascular Outcomes in Chronic Kidney Disease and Metabolic Acidosis: • CKD as a Model of Accelerated Aging and Patients with Chronic Kidney Disease Improvement in Physical Function with A Longitudinal Analysis from Electronic Medical Veverimer Records of > 50,000 Patients 38
Veverimer: Positive Reaction to Profile and Anticipated Adoption Supports Market Opportunity to Address a High Unmet Need Nephrologists Were Asked about Their Nephrologists Were Asked to Estimate Likelihood of Prescribing Veverimer* Veverimer Share at One Year* 79% Would Definitely or 52% Probably Prescribe Veverimer Share For Their Other 18% Patients, it will be Might “Watch and Wait” Prescribe Definitely/Probably Might Would Not Definitely Would Not Source: IQVIA Quant Q3’19 Nephrologist n=100 *Based on a target product profile including information from Wesson DE et al., Lancet. 2019; 393:1417-1427. Wesson DE et al., Lancet. 2019; 394:396-406. Quotation from Tricida Primary Market Research Qual Survey 2019, n=15. If approved, the veverimer prescribing information may differ. *We believe this estimate is more representative of peak share opportunity 39
Engaging with Payers to Facilitate Optimal Coverage $$$ $$$ $$$$ $$$ Managed Market Employing Multiple Payer Advisory Team Actively Meeting Avenues for Handling Board Meeting with Payers Prior Authorizations • Met with 10 payers representing ~100 • Field-based payer team of 12 • Mirror nephrologists’ current practice million lives in March 2020 representatives ˗ Preferred pharmacy (retail and specialty, as • Key takeaways: • Proactively targeting payers that preferred) ˗ First-in-class, must cover represent 95% of covered US lives ˗ Electronic Prior Authorization System ˗ Disease modification is important • Met with 77 payers representing >260 ˗ Patient Assistance Hub ˗ Positive reactions to health economics million lives ˗ Nephrologist staff education by 10 field analysis ˗ Goal is to meet with 100 payers prior to reimbursement managers ˗ Prior authorization likely (confirm serum approval at least once bicarbonate and sodium sensitivities) 40
Ongoing Payer Discussions Include Health Impact of Metabolic Acidosis Supportive Data from Analysis of Major Payer Database Shows Significant Health Impact of Metabolic Acidosis Over a Two-Year Period 3X 3.6X 1.5X Higher Likelihood Higher Likelihood of Higher Likelihood to Progress of Death Starting Dialysis 1 or More CKD Stages 50% 50% 50% 40% 40% 40% *38.3% *30.9% 30% 30% 30% 24.6% *18.0% 20% 20% 20% 10.2% 10% 10% 4.8% 10% 0% 0% 0% Mortality Chronic Dialysis Progression > 1 CDK Percent of Patients with with Outcome of Patients Percent Mortality Chronic Dialysis ProgressionStage, % ≥ 1 CKD Stage, % *p<0.0001 Metabolic Acidosis (N=17,350) Normal Serum Bicarbonate (N=34,208) Optum® EMR, De-identified electronic Health Record dataset 2007–2017. Tangri N, National Kidney Foundation Spring 2020 Data on file. 41
Ongoing Payer Discussions Include HEOR Analysis Compelling Health Economic Outcomes Research (HEOR) Message for Payers Impact of metabolic acidosis comparing Impact of increase in serum bicarbonate all-cause cost in an acidotic vs. as a continuous variable in combined non-acidotic population acidotic and non-acidotic population ~$40K of added costs/year Each 1 mEq/L increase in serum CKD stage 3 to 5 non-dialysis patients bicarbonate was associated with with metabolic acidosis costs ~$40K more than a 7% decrease in all cause monthly CKD patients with normal serum bicarbonate healthcare costs (p<0.0001) Optum® EMR, De-identified electronic medical records 2007–2017. Reaven N, Association of Managed Care Pharmacy; Oct 31, 2019 and ASN Kidney Week Nov 7, 2019 42
Patients with Commercial, Medicare with Subsidy, Medicaid and VA/DOD Patients Represent ~62% of Target Population Anticipated Payer Mix in Target Population 1% VA/DOD 5% VA/ Uninsured DODCash 10% Medicaid Medicaid33% Over half of the initial targeted patients with Medicare with CKD and metabolic acidosis will have either no subsidy low copay (Medicaid, Medicare with subsidy 33% and VA/DOD) or may have assistance with Commercial 18% their copay (commercial) Medicare with subsidy Symphony Health Solutions IDV® 2018 USRDS Annual Report, Kaiser Family Foundation 43
Veverimer: Multi-Billion Revenue Opportunity in the US with a Focus on the Nephrology Specialty US Revenue Metrics Est. WAC price: 3,000,000 ~$2,000 – $3,000/month Patients with CKD and Est. net price (~30% GtN): ~$1,400 – $2,100/month Metabolic Acidosis Est. compliance: 65% (~8 months/year) 1,100,000 Revenue PPPY: ~$14,000 (at midpoint) Patients Under Physician Care ~600,000 Patients Under Nephrologist Care 5% Share of 150,000 Total >$2 billion / year in the Rx Patients* Prevalence US Nephrology Specialty PPPY: Per Patient Per Year. *Incorporates intent to treat and managed care coverage assumptions 44
Veverimer: Worldwide Patent Estate United States Europe Rest of World • Six issued Orange Book • Three issued patents • Issued patents in Australia, eligible patents Hong Kong, Japan, Mexico and • Several pending Russia • Several pending patent patent applications applications • Corresponding pending patent applications in other commercially significant countries Patent protection expected to provide exclusivity for veverimer until at least June 5, 2034 in the United States, Australia, Hong Kong, Japan, Mexico and Russia and at least December 10, 2035 in Europe.* *Exclusivity does not include any extension related to Hatch-Waxman in the United States, or a Supplementary Protection Certificate in Europe. 45
Strong Financial Position ~ $355 million year-end cash, cash equivalents and investments as of December 31, 2019 $60 million currently drawn under a $200 million debt facility with Hercules (including $20 million drawn in December 2019) – Additional draw down availability of: • $15 million prior to December 15, 2020 • $75 million subject to FDA approval of veverimer and prior to December 15, 2020 • $50 million subject to approval by Hercules ~ 49.8 million total shares outstanding as of December 31, 2019 46
