Reata Pharmaceuticals, Inc. (Nasdaq: RETA), a clinical-stage
biopharmaceutical company, today announced financial results for
the second quarter ended June 30, 2019, and provided an update on
the Company’s business and product development programs.
Product Development Updates
Phase 2/3 CARDINAL Trial of Bardoxolone in
Alport Syndrome
The Phase 3 portion of CARDINAL is an
international, multi-center, randomized, double-blind,
placebo-controlled trial studying the safety and efficacy of
bardoxolone methyl (bardoxolone) in patients with chronic kidney
disease caused by Alport syndrome. Enrollment in the pivotal
Phase 3 portion of CARDINAL was completed last year with 157
patients. We expect to announce one-year, top-line results
from CARDINAL in the second half of 2019. The U.S. Food and
Drug Administration (FDA) has provided guidance that an improvement
in retained estimated glomerular filtration rate (eGFR) versus
placebo after 48 weeks of treatment and a four-week drug withdrawal
period may support accelerated approval under subpart H. Data
demonstrating an improvement versus placebo in retained eGFR after
two years may support full approval. No safety concerns have
been reported by the data monitoring committee.
MOXIe Trial of Omaveloxolone in Friedreich’s
Ataxia
MOXIe is a two-part, international,
multi-center, randomized, double-blind, placebo-controlled
registrational trial studying the safety and efficacy of
omaveloxolone in patients with Friedreich’s ataxia (FA). Enrollment
in the pivotal part 2 of MOXIe was completed last year with 103
patients, and we expect to announce top-line data in the second
half of 2019. The FDA has provided guidance that an analysis
of modified Friedreich’s Ataxia Rating Scale (mFARS) scores
demonstrating an improvement versus placebo after 48 weeks of
omaveloxolone treatment may support submission of a New Drug
Application for omaveloxolone for the treatment of FA. No
safety concerns have been reported by the data monitoring
committee.
Phase 3 FALCON Trial of Bardoxolone in Autosomal
Dominant Polycystic Kidney Disease
We announced in May 2019 that the first patient
was enrolled in a registrational Phase 3 trial called FALCON, an
international, multi-center, randomized, double-blind,
placebo-controlled trial studying the safety and efficacy of
bardoxolone in approximately 300 patients with autosomal dominant
polycystic kidney disease. The FDA has provided guidance that
an improvement in retained eGFR versus placebo at one year may
support accelerated approval under subpart H, and that data
demonstrating an improvement versus placebo in retained eGFR after
two years may support full approval.
Phase 3 CATALYST Trial of Bardoxolone in
Connective Tissue Disease-Associated Pulmonary Arterial
Hypertension
We are conducting the pivotal Phase 3 CATALYST
trial of bardoxolone in patients with pulmonary arterial
hypertension associated with connective tissue disease, an
often-fatal manifestation of many types of autoimmune disease,
including systemic sclerosis (scleroderma) and systemic lupus
erythematosus. The trial will enroll approximately 200
patients, with top-line data expected in the first half of
2020.
Selected Clinical Milestones in
2019
- Pivotal CARDINAL data in the second half of 2019
- Pivotal MOXIe data in the second half of 2019
Financial Highlights
The Company incurred total expenses of $41.5
million for the quarter ended June 30, 2019, with research and
development accounting for $29.6 million. This compares to
total expenses of $34.2 million for the same period of the year
prior, when research and development accounted for $23.4
million. We reported a net loss of $34.4 million or $1.14 per
share for the quarter ended June 30, 2019. This compares to a
net loss of $28.2 million or $1.08 per share in the same period of
the year prior.
The net loss for the three-month period compared
to the year prior is primarily driven by an increase in expenses
while revenue remained consistent to the year prior. Higher
expenses were driven by an increase in research and development
expenses due to clinical, manufacturing, and medical affairs
activities, and an increase in personnel expenses to support growth
of our development activities.
We incurred total expenses of $77.8 million for
the six month period ended June 30, 2019, with research and
development accounting for $55.7 million. This compares to
total expenses of $62.4 million for the same period of the year
prior, when research and development accounted for $44.8
million. We reported a net loss of $63.5 million or $2.12 per
share for the six month period ended June 30, 2019. This
compares to a net loss of $24.1 million or $0.92 per share in the
same period of the year prior.
The increase in net loss for the six month
period is driven primarily by both an increase in expenses and a
decrease in revenue. Higher expenses were driven by an
increase in research and development expenses due to clinical,
manufacturing, and medical affairs activities, and an increase in
personnel expenses to support expanded development
activities. Revenue to date has primarily been related to
license and collaboration agreements entered into during 2009,
2010, and 2011. The decrease in revenue was primarily due to
an increase in revenue recognized in the first quarter of 2018 from
the portion of a $30 million milestone from Kyowa Kirin Company
that was included in the transaction price for which we did not
have a similar event during 2019.
Our cash-based operating expenses, a non-GAAP
measure, were $36.8 million and $68.7 million for the three and six
months ended June 30, 2019, respectively. This compares to
$31.6 million and $57.1 million for the same period of the year
prior. Cash-based operating expenses for the quarters ended
June 30 and March 31, 2019, were $36.8 million and $31.9 million,
respectively. The increase in cash-based operating
expenses for the three months ended June 30, 2019, were driven by
increased manufacturing and clinical activities, as well as
increased personnel costs to support growth in our development
activities. We expect our cash-based operating expenses to
continue to increase in the future as we advance bardoxolone and
omaveloxolone through ongoing and future clinical trials, scale
manufacturing for registrational and validation purposes, advance
other product candidates into mid- and later-stage clinical trials,
expand our product candidate portfolio, increase both our research
and development and administrative personnel, and plan for
commercialization of our product candidates.
At June 30, 2019, we had $280.4 million in cash
and cash equivalents. We expect our current cash to fund our
operations through data readouts for CARDINAL, MOXIe, and
CATALYST.
Non-GAAP Financial Measures
In addition to the U.S. generally accepted
accounting principles (GAAP) financial highlights, this earnings
release includes cash-based operating expenses, a non-GAAP
financial measure, which the Company defines as total expenses
excluding stock-based compensation expense and depreciation
expense. A reconciliation of this non-GAAP financial measure
to its most directly comparable GAAP financial measure is presented
in the table below in this earnings release.
We believe that this non-GAAP financial measure,
in addition to GAAP financial measures, provides a meaningful
measure of our ongoing business and operating performance by
allowing investors to analyze our financial results similarly to
how management analyzes our financial results by viewing period
expense totals more indicative of effort directly expended to
advance the business and our product candidates. Non-GAAP
financial measures should be considered in addition to, not in
isolation or as a substitute for, GAAP financial measures. In
addition, our non-GAAP financial measure may differ from similarly
named measures used by other companies.
CONFERENCE CALL INFORMATION |
|
|
Date: |
Wednesday, August 8, 2019 |
Time: |
8:00 a.m. ET |
Audience Dial-in (toll-free): |
(844) 348-3946 |
Audience Dial-in (international): |
(213) 358-0892 |
Conference ID: |
7587139 |
Webcast Link: |
https://edge.media-server.com/mmc/p/h8xmbyuj |
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30 |
|
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
Consolidated Statements of Operations |
|
(Unaudited) |
|
|
|
(in thousands, except share and per share
data) |
|
Collaboration revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License and milestone |
|
$ |
7,813 |
|
|
$ |
7,519 |
|
|
$ |
15,539 |
|
|
$ |
39,686 |
|
Other revenue |
|
|
20 |
|
|
|
52 |
|
|
|
64 |
|
|
|
276 |
|
Total collaboration revenue |
|
|
7,833 |
|
|
|
7,571 |
|
|
|
15,603 |
|
|
|
39,962 |
|
Expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
29,554 |
|
|
|
23,429 |
|
|
|
55,668 |
|
|
|
44,835 |
|
General and administrative |
|
|
11,706 |
|
|
|
10,689 |
|
|
|
21,744 |
|
|
|
17,317 |
|
Depreciation |
|
|
232 |
|
|
|
105 |
|
|
|
401 |
|
|
|
206 |
|
Total expenses |
|
|
41,492 |
|
|
|
34,223 |
|
|
|
77,813 |
|
|
|
62,358 |
|
Other income (expense) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investment income |
|
|
1,705 |
|
|
|
357 |
|
|
|
3,502 |
|
|
|
693 |
|
Interest expense |
|
|
(2,413 |
) |
|
|
(903 |
) |
|
|
(4,810 |
) |
|
|
(1,413 |
) |
Loss on extinguishment of debt |
|
|
- |
|
|
|
(1,007 |
) |
|
|
- |
|
|
|
(1,007 |
) |
Other income (expense) |
|
|
7 |
|
|
|
- |
|
|
|
7 |
|
|
|
- |
|
Total other income (expense) |
|
|
(701 |
) |
|
|
(1,553 |
) |
|
|
(1,301 |
) |
|
|
(1,727 |
) |
Loss before taxes on income |
|
|
(34,360 |
) |
|
|
(28,205 |
) |
|
|
(63,511 |
) |
|
|
(24,123 |
) |
Provision for taxes on income |
|
|
20 |
|
|
|
6 |
|
|
|
23 |
|
|
|
6 |
|
Net loss |
|
$ |
(34,380 |
) |
|
$ |
(28,211 |
) |
|
$ |
(63,534 |
) |
|
$ |
(24,129 |
) |
Net loss per share—basic and diluted |
|
$ |
(1.14 |
) |
|
$ |
(1.08 |
) |
|
$ |
(2.12 |
) |
|
$ |
(0.92 |
) |
Weighted-average number of common shares |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
used in net loss per share basic and diluted |
|
|
30,069,048 |
|
|
|
26,178,793 |
|
|
|
29,950,241 |
|
|
|
26,167,033 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2019(unaudited) |
|
|
December 31, 2018 |
|
|
|
(in
thousands) |
|
Condensed Consolidated Balance Sheet Data |
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
280,449 |
|
|
$ |
337,790 |
|
Working
capital |
|
|
219,502 |
|
|
|
286,353 |
|
Total
assets |
|
|
300,488 |
|
|
|
345,208 |
|
Term
loan |
|
|
79,897 |
|
|
|
79,219 |
|
Deferred
revenue (including current portion) |
|
|
210,182 |
|
|
|
225,721 |
|
Accumulated deficit |
|
|
(483,857 |
) |
|
|
(420,323 |
) |
Total stockholders’
equity (deficit) |
|
$ |
(33,473 |
) |
|
$ |
15,159 |
|
Reconciliation of GAAP to
Non-GAAP Financial Measures
The following table presents results for the
three months ending (in thousands) (unaudited):
|
2019 |
|
|
2018 |
|
|
June 30 |
|
|
March 31 |
|
|
December 31 |
|
|
September 30 |
|
|
June 30 |
|
|
March 31 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total expenses - GAAP |
$ |
41,492 |
|
|
$ |
36,322 |
|
|
$ |
33,373 |
|
|
$ |
34,735 |
|
|
$ |
34,223 |
|
|
$ |
28,136 |
|
Stock-based compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
expense |
|
(4,483 |
) |
|
|
(4,227 |
) |
|
|
(2,768 |
) |
|
|
(2,745 |
) |
|
|
(2,552 |
) |
|
|
(2,485 |
) |
Depreciation |
|
(232 |
) |
|
|
(170 |
) |
|
|
(120 |
) |
|
|
(105 |
) |
|
|
(105 |
) |
|
|
(101 |
) |
Cash-based operating |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
expenses - Non-GAAP |
$ |
36,777 |
|
|
$ |
31,925 |
|
|
$ |
30,485 |
|
|
$ |
31,885 |
|
|
$ |
31,566 |
|
|
$ |
25,550 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change from previous |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
quarter |
$ |
4,852 |
|
|
$ |
1,440 |
|
|
$ |
(1,400 |
) |
|
$ |
319 |
|
|
$ |
6,016 |
|
|
$ |
961 |
|
Percentage change from |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
previous quarter |
|
15 |
% |
|
|
5 |
% |
|
|
-4 |
% |
|
|
1 |
% |
|
|
24 |
% |
|
|
4 |
% |
About Reata Pharmaceuticals,
Inc.
Reata is a clinical-stage biopharmaceutical
company that develops novel therapeutics for patients with serious
or life-threatening diseases by targeting molecular pathways
involved in the regulation of cellular metabolism and
inflammation. Reata’s two most advanced clinical candidates,
bardoxolone and omaveloxolone, target the important transcription
factor Nrf2 that promotes restoration of mitochondrial function,
reduction of oxidative stress, and inhibition of pro-inflammatory
signaling. Bardoxolone and omaveloxolone are
investigational drugs, and their safety and efficacy have not been
established by any agency.
Forward-Looking Statements
This press release includes certain disclosures
that contain “forward-looking statements,” including, without
limitation, statements regarding the success, cost and timing of
our product development activities and clinical trials, our plans
to research, develop and commercialize our product candidates, and
our ability to obtain and retain regulatory approval of our product
candidates. You can identify forward-looking statements
because they contain words such as “believes,” “will,” “may,”
“aims,” “plans,” “model,” and “expects.” Forward-looking
statements are based on Reata’s current expectations and
assumptions. Because forward-looking statements relate to the
future, they are subject to inherent uncertainties, risks, and
changes in circumstances that may differ materially from those
contemplated by the forward-looking statements, which are neither
statements of historical fact nor guarantees or assurances of
future performance. Important factors that could cause actual
results to differ materially from those in the forward-looking
statements include, but are not limited to, (i) the timing, costs,
conduct, and outcome of our clinical trials and future preclinical
studies and clinical trials, including the timing of the initiation
and availability of data from such trials; (ii) the timing and
likelihood of regulatory filings and approvals for our product
candidates; (iii) the potential market size and the size of the
patient populations for our product candidates, if approved for
commercial use, and the market opportunities for our product
candidates; and (iv) other factors set forth in Reata’s filings
with the U.S. Securities and Exchange Commission, including its
Annual Report on Form 10-K, under the caption “Risk Factors.”
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.
Contact:Reata Pharmaceuticals, Inc.(972)
865-2219http://reatapharma.com
Investors:Vinny JindalVice President,
Strategy(469)
374-8721ir@reatapharma.comhttp://reatapharma.com/contact-us/
Media:Matt Middleman, M.D.LifeSci Public
Relations(646)
627-8384matt.middleman@lifescipublicrelations.com
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