19
1 FOURTH QUARTER AND FULL YEAR 2019 EARNINGS CALL February 19, 2020

FOURTH QUARTER AND FULL YEAR 2019 EARNINGS CALL · 2020-02-29 · Bardoxolone methyl and omaveloxolone are investigational drugs, and their safety and efficacy have not been established

  • Upload
    others

  • View
    0

  • Download
    0

Embed Size (px)

Citation preview

Page 1: FOURTH QUARTER AND FULL YEAR 2019 EARNINGS CALL · 2020-02-29 · Bardoxolone methyl and omaveloxolone are investigational drugs, and their safety and efficacy have not been established

1

FOURTH QUARTER AND FULL

YEAR 2019 EARNINGS CALL

February 19, 2020

Page 2: FOURTH QUARTER AND FULL YEAR 2019 EARNINGS CALL · 2020-02-29 · Bardoxolone methyl and omaveloxolone are investigational drugs, and their safety and efficacy have not been established

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.

Page 3: FOURTH QUARTER AND FULL YEAR 2019 EARNINGS CALL · 2020-02-29 · Bardoxolone methyl and omaveloxolone are investigational drugs, and their safety and efficacy have not been established

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

Page 4: FOURTH QUARTER AND FULL YEAR 2019 EARNINGS CALL · 2020-02-29 · Bardoxolone methyl and omaveloxolone are investigational drugs, and their safety and efficacy have not been established

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

Page 5: FOURTH QUARTER AND FULL YEAR 2019 EARNINGS CALL · 2020-02-29 · Bardoxolone methyl and omaveloxolone are investigational drugs, and their safety and efficacy have not been established

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

Page 6: FOURTH QUARTER AND FULL YEAR 2019 EARNINGS CALL · 2020-02-29 · Bardoxolone methyl and omaveloxolone are investigational drugs, and their safety and efficacy have not been established

6

Chronic Kidney DiseaseBardoxolone

Page 7: FOURTH QUARTER AND FULL YEAR 2019 EARNINGS CALL · 2020-02-29 · Bardoxolone methyl and omaveloxolone are investigational drugs, and their safety and efficacy have not been established

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

Page 8: FOURTH QUARTER AND FULL YEAR 2019 EARNINGS CALL · 2020-02-29 · Bardoxolone methyl and omaveloxolone are investigational drugs, and their safety and efficacy have not been established

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

Page 9: FOURTH QUARTER AND FULL YEAR 2019 EARNINGS CALL · 2020-02-29 · Bardoxolone methyl and omaveloxolone are investigational drugs, and their safety and efficacy have not been established

9

NeurologyOmaveloxolone and RTA 901

Page 10: FOURTH QUARTER AND FULL YEAR 2019 EARNINGS CALL · 2020-02-29 · Bardoxolone methyl and omaveloxolone are investigational drugs, and their safety and efficacy have not been established

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)

Page 11: FOURTH QUARTER AND FULL YEAR 2019 EARNINGS CALL · 2020-02-29 · Bardoxolone methyl and omaveloxolone are investigational drugs, and their safety and efficacy have not been established

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)

Page 12: FOURTH QUARTER AND FULL YEAR 2019 EARNINGS CALL · 2020-02-29 · Bardoxolone methyl and omaveloxolone are investigational drugs, and their safety and efficacy have not been established

12

Pulmonary DiseaseBardoxolone

Page 13: FOURTH QUARTER AND FULL YEAR 2019 EARNINGS CALL · 2020-02-29 · Bardoxolone methyl and omaveloxolone are investigational drugs, and their safety and efficacy have not been established

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

Page 14: FOURTH QUARTER AND FULL YEAR 2019 EARNINGS CALL · 2020-02-29 · Bardoxolone methyl and omaveloxolone are investigational drugs, and their safety and efficacy have not been established

14

Commercial Readiness

Page 15: FOURTH QUARTER AND FULL YEAR 2019 EARNINGS CALL · 2020-02-29 · Bardoxolone methyl and omaveloxolone are investigational drugs, and their safety and efficacy have not been established

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

Page 16: FOURTH QUARTER AND FULL YEAR 2019 EARNINGS CALL · 2020-02-29 · Bardoxolone methyl and omaveloxolone are investigational drugs, and their safety and efficacy have not been established

16

Financial Updates

Page 17: FOURTH QUARTER AND FULL YEAR 2019 EARNINGS CALL · 2020-02-29 · Bardoxolone methyl and omaveloxolone are investigational drugs, and their safety and efficacy have not been established

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

Page 18: FOURTH QUARTER AND FULL YEAR 2019 EARNINGS CALL · 2020-02-29 · Bardoxolone methyl and omaveloxolone are investigational drugs, and their safety and efficacy have not been established

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)

Page 19: FOURTH QUARTER AND FULL YEAR 2019 EARNINGS CALL · 2020-02-29 · Bardoxolone methyl and omaveloxolone are investigational drugs, and their safety and efficacy have not been established

19

QUESTIONS