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1
FOURTH QUARTER AND FULL
YEAR 2019 EARNINGS CALL
February 19, 2020
2
Forward-Looking StatementsThis presentation contains certain “forward-looking” statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical or present facts, are forward-looking statements, including statements regarding our future financial condition, future revenues, projected costs, prospects, business strategy, and plans and objectives of management for future operations, including our plans to submit for regulatory filings. In some cases, you can identify forward-looking statements by terminology such as “believe,” “will,” “may,” “might,” “estimate,” “continue,” “anticipate,” “intend,” “target,” “project,” “model,” “should,” “would,” “plan,” “expect,” “predict,” “could,” “seek,” “goal,” “potential,” or the negative of these terms or other similar terms or expressions that concern our expectations, strategy, plans, or intentions. These statements are based on our intentions, beliefs, projections, outlook, analyses, or current expectations using currently available information, and are not guarantees of future performance, and involve certain risks and uncertainties. Although we believe that the expectations reflected in these forward-looking statements are reasonable, we cannot assure you that our expectations will prove to be correct. Therefore, actual outcomes and results could materially differ from what is expressed, implied, or forecasted in these statements. Any differences could be caused by a number of factors including but not limited to: our expectations regarding the timing, costs, conduct, and outcome of our clinical trials, including statements regarding the timing of the initiation and availability of data from such trials; the timing and likelihood of regulatory filings and approvals for our product candidates; whether regulatory authorities determine that additional trials or data are necessary in order to obtain approval; our ability to obtain funding for our operations, including funding necessary to complete further development and commercialization of our product candidates; our plans to research, develop, and commercialize our product candidates; the commercialization of our product candidates, if approved; the rate and degree of market acceptance of our product candidates; our expectations regarding the potential market size and the size of the patient populations for our product candidates, if approved for commercial use, and the potential market opportunities for commercializing our product candidates; the success of competing therapies that are or may become available; our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates; the ability to license additional intellectual property relating to our product candidates and to comply with our existing license agreements; our ability to maintain and establish relationships with third parties, such as contract research organizations, suppliers, and distributors; our ability to maintain and establish collaborators with development, regulatory, and commercialization expertise; our ability to attract and retain key scientific or management personnel; our ability to grow our organization and increase the size of our facilities to meet our anticipated growth; the accuracy of our estimates regarding expenses, future revenue, capital requirements, and needs for additional financing; our expectations related to the use of our available cash; our ability to develop, acquire, and advance product candidates into, and successfully complete, clinical trials; the initiation, timing, progress, and results of future preclinical studies and developments and projections relating to our competitors and our industry.
Additional factors that could cause actual results to differ materially from our expectations can be found in our Securities and Exchange Commission filings. Moreover, we operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time, and it is not possible for our management to predict all risk factors, nor can we assess the effects of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements. All forward-looking statements included in this presentation are expressly qualified in their entirety by these cautionary statements. The forward-looking statements speak only as of the date made and, other than as required by law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
Bardoxolone methyl and omaveloxolone are investigational drugs, and their safety and efficacy have not been established by any agency.
3
Reata at a Glance
Global Opportunity
• Few or no effective therapies currently approved for lead indications
• Reata possesses worldwide commercial rights to all pipeline assets5
• Commercial leadership in place for global commercial launches
• Robust intellectual property protection for Bard and Omav
Chronic Kidney Disease Franchise
• Positive pivotal data for Bard1 in
Alport syndrome (AS)
• Bard pipeline in rare forms of CKD3
• Pivotal ADPKD4 study ongoing
• Positive proof-of-concept data in
FSGS4, IgAN4, and T1D-CKD4
Neurology Franchise
• Positive pivotal data for Omav2 in
Friedreich’s ataxia (FA)
• Plan to study Omav and RTA 901
in additional indications in
neurological disease
1Bard: bardoxolone methyl; 2Omav: omaveloxolone; 3CKD: chronic kidney disease; 4ADPKD: autosomal dominant polycystic kidney disease, FSGS: focal segmental glomerulosclerosis, IgAN: IgA nephropathy, T1D-CKD: type 1 diabetes CKD; 5ex-Asia for Bard
4
DISCOVERY PRECLINICAL PHASE 1 PHASE 2 PIVOTAL NDA
CKD Caused by Alport Syndrome | Bard*
Friedreich’s Ataxia | Omav
IgA Nephropathy | Bard
Type 1 Diabetic CKD | Bard
Focal Segmental Glomerulosclerosis | Bard
Neurological Indications | RTA 901
Autoimmune Indications | RTA 1701
Connective Tissue Disease-Associated Pulmonary Arterial Hypertension | Bard
Deep Pipeline With Two Pre-Registration Programs and
Two Pivotal Studies Ongoing
Autosomal Dominant Polycystic Kidney Disease | Bard
*The CARDINAL study reported one-year data in November 2019, and is an ongoing two-year study
5
Neurological Disease
Metabolic Disease
Respiratory Disease
Liver Disease
Autoimmune Disease
Friedreich’s ataxia, Parkinson’s disease,
Dementia, Epilepsy, Huntington’s disease, ALS,
Alzheimer’s disease
CEC loss, Retinal degeneration,
Glaucoma, Macular degeneration
CHF, Myocardial infarction,
Atherosclerosis
Diabetes, Weight loss, Aerobic capacity,
Metabolic syndrome, OsteoporosisRA, IBD, MS, Scleroderma,
Lupus, Graft versus host disease
Clinical improvements in liver
function, NASH, Cirrhosis
CTD-PAH, IPF, CF, COPD
Chronic Kidney Disease
Alport syndrome, Diabetic CKD,
ADPKD, IgA nephropathy, FSGS
Nrf2
Restores
Mitochondrial
Function
Reduces
Fibrosis
Inhibits
Inflammatory
Signaling
Evidence for the Potential Use of our Nrf2 Activators in
the Treatment of Many Diseases
Clinical Proof of Concept, Preclinical Proof of Concept
Ocular Disease
Cardiovascular
Disease
6
Chronic Kidney DiseaseBardoxolone
7
Bardoxolone in Development for Rare CKD
Significant opportunity in rare forms of CKD‒ Estimated aggregate prevalence exceeds
700,000 patients in the US
‒ Few or no effective therapies currently approved
Pivotal CARDINAL Phase 3 study in Alport syndrome (AS) met its primary and key secondary endpoints
FALCON Phase 3 study in ADPKD‒ FALCON design and endpoints similar to
CARDINAL Phase 3 study
‒ Initiated in May 2019
Positive data from PHOENIX in IgAN, FSGS and T1D-CKD; planning to pursue commercially
US Rare CKD Patients
ADPKD5
T1D-CKD4
FSGS2
IgAN3
Alport
Syndrome1
~400,000
~160,000
~120,000
~40,000
~30,000-
60,000
1Alport Syndrome Foundation; Estimated based on Persson Clin Nephrol (2005); USRDS Report; Hasstedt Am J Hum Genet (1983); Temme,Kidney Int (2012); 2Wetmore (2016), Sim (2016); 3Berthoux (2011), Wetmore (2016), Sim (2016); 4American Diabetes Association, Garofolo (2018), Ohta (2010); 5PKD Foundation
8
CARDINAL Phase 3 Met Key Secondary Endpoint
Double-blind, placebo-controlled, international, registrational trial
Bard treatment significantly improved off-treatment eGFR at Week 52 by 5.14 ml/min relative to placebo (p=0.0012)
Bard was generally reported to be well tolerated
Off-treatment eGFR benefit versus placebo was the approval endpoint for JYNARQUE in the US for the treatment of ADPKD
Launch preparations for Bard in AS are underway
-6.11
-0.96
-8
-7
-6
-5
-4
-3
-2
-1
0
Mean
±S
E e
GF
R C
han
ge (
ml/
min
)
Placebo (n=80) Bardoxolone Methyl (n=77)
p=0.0012
Key Secondary Endpoint:
eGFR Change at Week 52
*p-value estimated comparing the mean changes to zero
ANCOVA analyses include off-treatment eGFR values
from patients that discontinued treatment early
9
NeurologyOmaveloxolone and RTA 901
10
MOXIe Pivotal Study: Design and Results
International, double-blind, placebo-controlled, randomized, registrational trial‒ Largest global interventional study in patients with FA
‒ Enrolled a wide and representative range of patients with FA
‒ Patients randomized 1:1 to receive 150 mg Omav or placebo for 48 weeks
MOXIe successfully met its primary endpoint of change in the mFARS relative to placebo after 48 weeks of treatment
Omav was generally reported to be well tolerated, and reported adverse events were generally mild to moderate in intensity
Worsened
Improved-1.55 pts
+0.85 pts
-2.0
-1.0
0.0
1.0
0 12 24 36 48
Ch
an
ge f
rom
Baselin
e i
n m
FA
RS
Study Week
Placebo (n=42) Omav (n=40)
11
Omav Pharmacology May Be Applicable to Broad Set of
Neurological Diseases
MOXIe results provide proof of concept for use of Omav in other neurodegenerative diseases
Mitochondrial dysfunction and neuroinflammation are common features of FA and other neurological diseases
Omav and analogs have demonstrated broad activity in neurological models
‒ Parkinson’s disease
‒ Dementia
‒ Epilepsy
‒ Huntington’s disease
‒ Amyotrophic lateral sclerosis (ALS)
‒ Alzheimer’s disease
Yang et al., PLoS One (2009); Neymotin et al., Free Rad Bio (2011); Dinkova-Kostova et al., (2015)Stack et al., Free Rad Biol Med 49 (2010); Dumont et al., J Neurochem (2009); Kim et al., Cells (2019); Shekh-Ahmad, et al., Brain (2018); Wei et al., Sci Rep (2017)
12
Pulmonary DiseaseBardoxolone
13
CATALYST: Global Pivotal Trial of Bard for Treatment of
CTD-PAH
Phase 3 enrollment is complete at 202 patients‒ Randomized, double-blind, placebo-controlled international study
‒ 24-week treatment duration
Broad eligibility criteria‒ 6MWD ≥ 150 meters
‒ Age 18-75 years old
‒ WHO Functional Class II and III on up to two background therapies
6MWD endpoint supports approval‒ Potential full approval on 6MWD after 24 weeks of treatment
‒ Conservatively powered
Data expected mid-2020
Placebo
Bard: 10 mg
R
Day 1 Week24
Bard: 5 mg
Screen Dose-Titration Maintenance
14
Commercial Readiness
15
Commercial Infrastructure and Experience
Marketing Market Access Sales Operations Manufacturing
Reata is poised to support two parallel product launches
Commercial leadership team and direct reports are
hired. Actively preparing for 2 product launches
Sr. Leadership has over 150 combined years of
biotech marketing, trade, access, pricing, sales,
international commercial and product launch
experience
Past experience includes Pharmacyclics, BioMarin,
Alexion, Shire, Genentech
Commercial organization is poised for growth to
support our US and global launches
16
Financial Updates
17
Financial Highlights
Condensed Statements of
Operations
Three Months Ended December 31
(unaudited)Twelve Months Ended December 31
(in thousands, except share and per share data)
2019 2018 2019 2018
Total Collaboration Revenue $ 2,672 $ 8,451 $ 26,517 $ 53,589
Expenses
Research and development $ 40,161 $ 25,308 $ 128,109 $ 97,288
Reacquired license rights $ 124,398 $ – $ 124,398 $ –
General and administrative $ 22,271 $ 7,945 $ 58,298 $ 32,748
Depreciation $ 273 $ 120 $ 932 $ 431
Total Expenses $ 187,103 $ 33,373 $ 311,737 $ 130,467
Net loss $ (186,942) $ (25,582) $ (290,170) $ (80,546)
Net loss per share (basic and
diluted)$ (5.91) $ (0.86) $ (9.54) $ (2.91)
Weighted-average number of
common shares used in net loss
per share (basic and diluted)
31,630,810 29,716,666 30,414,203 27,701,783
December 31, 2019 December 31, 2018
(in thousands)
Cash and Cash Equivalents $ 664,324 $ 337,790
We expect our current cash to fund our operations and capital expenditure requirements through the end of 2021
18
Reconciliation of GAAP to Non-GAAP Financial Measures
Three Months Ended Twelve Months Ended
December 31, December 31,
(in thousands, except for per share data) (unaudited)
2019 2018 2019 2018
Reconciliation of GAAP to Non-GAAP Research and development:
GAAP Research and development $ 40,161 $ 25,308 $ 128,109 $ 97,288
Less: Stock-based compensation expense (3,458) (1,020) (8,692) (3,943)
Non-GAAP Research and development $ 36,703 $ 24,288 $ 119,417 $ 93,345
Reconciliation of GAAP to Non-GAAP General and administrative:
GAAP General and administrative $ 22,271 $ 7,945 $ 58,298 $ 32,748
Less: Stock-based compensation expense (8,833) (1,748) (17,689) (6,606)
Non-GAAP General and administrative $ 13,438 $ 6,197 $ 40,609 $ 26,142
Reconciliation of GAAP to Non-GAAP Operating expenses:
GAAP Operating expense $ 187,103 $ 33,373 $ 311,737 $ 130,467
Less: Stock-based compensation expense (12,291) (2,768) (26,381) (10,550)
Less: Reacquired license rights (124,398) - (124,398) -
Non-GAAP Operating expense $ 50,414 $ 30,605 $ 160,958 $ 119,917
Reconciliation of GAAP to Non-GAAP Net loss:
GAAP Net loss $ (186,942) $ (25,582) $ (290,170) $ (80,546)
Add: Stock-based compensation expense 12,291 2,768 26,381 10,550
Add: Reacquired license rights 124,398 - 124,398 -
Non-GAAP Net loss $ (50,253) $ (22,814) $ (139,391) $ (69,996)
Reconciliation of GAAP to Non-GAAP Net loss per common share-basic and diluted:
GAAP Net loss per common share-basic and diluted $ (5.91) $ (0.86) $ (9.54) $ (2.91)
Add: Stock-based compensation expense 0.39 0.09 0.87 0.38
Add: Reacquired license rights 3.93 - 4.09 -
Non-GAAP Net loss per common share-basic and diluted $ (1.59) $ (0.77) $ (4.58) $ (2.53)
19
QUESTIONS