Reata Pharmaceuticals, Inc. (Nasdaq: RETA) (“Reata,” the “Company,”
or “we”), a clinical-stage biopharmaceutical company, today
announced financial results for the quarter ended September 30,
2020, and provided an update on the Company’s business operations
and clinical development programs.
Clinical and Regulatory
Update
Bardoxolone Methyl (“Bardoxolone”) for Alport
Syndrome
In a separate press release issued today, we
announced that the Phase 3 CARDINAL study of bardoxolone in
patients with chronic kidney disease (“CKD”) caused by Alport
syndrome met its primary and key secondary endpoints at the end of
Year 2. At Week 100, in the intent-to-treat (“ITT”) population,
which included eGFR values for patients who remained on or
discontinued study drug, patients treated with bardoxolone had a
statistically significant improvement compared to placebo in mean
change from baseline in estimated glomerular filtration rate
(“eGFR”) of 7.7 mL/min/1.73 m2 (p=0.0005). In the modified ITT
(“mITT”) analysis, which assessed the effect of receiving treatment
by excluding values after patients discontinued treatment, patients
treated with bardoxolone had a statistically significant
improvement compared to placebo in mean change from baseline in
eGFR at Week 100 of 11.3 mL/min/1.73 m2 (p<0.0001). At Week 104
(four-weeks after last dose in second year of treatment), patients
in the ITT population treated with bardoxolone had a statistically
significant improvement compared to placebo in mean change from
baseline in eGFR of 4.3 mL/min/1.73 m2 (p=0.023). Bardoxolone
treatment was generally reported to be well-tolerated. In the
long-term extension study, in the 14 patients who completed three
years of treatment, bardoxolone treatment resulted in a mean
increase from baseline in eGFR of 11.0 mL/min/1.73 m2.
Based on these positive results and following a
recently completed pre-New Drug Application (“NDA”) meeting with
the U.S. Food and Drug Administration (“FDA”), the Company plans to
proceed with the submission of an NDA for full marketing approval
in the United States in the first quarter of 2021. We will also
continue preparations to file for marketing approval in Europe.
The press release can be found at the Investors
section of our website at www.reatapharma.com.
Omaveloxolone for Friedreich’s Ataxia (“FA”)
As previously announced, at a Type C meeting, the
FDA provided us guidance that although it does not have any
concerns with the reliability of the modified Friedreich’s Ataxia
Rating Scale (“mFARS”) primary endpoint results from the
registrational Part 2 of the MOXIe trial (“Part 2”) of
omaveloxolone in FA patients, it was not convinced that the results
from Part 2 support a single study approval. The FDA stated that we
will need to conduct a second pivotal trial that confirms the mFARS
results of Part 2 with a similar magnitude of effect. As an
alternative, Reata proposed a second study (“the
Baseline-Controlled Study”, previously called the crossover study)
in which patients serve as their own controls, and changes in mFARS
during the pre-treatment period in either Part 1 or Part 2 of the
MOXIe study are compared to changes in mFARS during the treatment
period in the open-label extension study (“MOXIe Extension”). The
design of the Baseline-Controlled Study was discussed and agreed
upon by external experts and Reata, and the statistical analysis
plan was submitted to the FDA prior to conducting the analysis
contemplated by the proposed plan. The FDA acknowledged it would
consider the study design but, to date, it has not provided
comments on the study design.
The Baseline-Controlled Study met its primary
endpoint of paired difference in annualized mFARS slope with a
statistically significant 3.76 point improvement (p=0.0022) between
the treatment and pre-treatment periods in the primary analysis
population. Further, all sensitivity analyses of the primary
analysis showed a significant treatment effect. Thus, we believe
that the results of the Baseline-Controlled Study support the
positive mFARS results of Part 2 and provide additional evidence of
the effectiveness of omaveloxolone in FA.
We completed the Baseline-Controlled Study in
October 2020 and provided the results to the FDA. The FDA confirmed
that it will review the study results and may request a meeting
with us to discuss the conclusions of its review. If the FDA views
these results as sufficient to increase the persuasiveness of data
from Part 2, our plan would be to submit an NDA in mid-2021.
However, there can be no assurance that the FDA will accept the
design of the Baseline-Controlled Study or view these results as
sufficient, in which case we will determine next steps, including
whether it is feasible to conduct a second pivotal study in
patients with FA as previously suggested by the FDA. At present, we
plan to pursue marketing approval outside of the United States and
work has commenced on preparations to file for marketing approval
in Europe.
Clinical Development
Update
FALCON Phase 3 Study of Bardoxolone in Autosomal
Dominant Polycystic Kidney Disease (“ADPKD”)
We began to lift the screening hold in FALCON in
June 2020, and currently, most sites are able to screen and
randomize patients. The measures we implemented to the conduct of
FALCON in response to COVID-19 have been effective, and we
anticipate no meaningful impact on data integrity due to
COVID-19.
BARCONA Investigator-Sponsored Trial (“IST”) of
Bardoxolone in Patients with COVID-19
The Phase 2 BARCONA IST study of bardoxolone in
patients with COVID-19 is a randomized, double-blind trial that
will enroll approximately 40 patients with a primary endpoint of
safety and treatment duration of up to 29 days in hospitalized
patients. To further mitigate any safety risk, the trial was
designed to pause after the enrollment of five patients to assess
safety. The first five patients were enrolled, and the Executive
Steering Committee reviewed the blinded safety data and decided to
continue with enrollment. As with all trials conducted at New York
University’s Grossman School of Medicine (“NYU”), the trial will be
overseen by a Data Safety Monitoring Board that meets every other
week. Any further enrollment in a potential Phase 3 trial will be
gated based on an assessment of Phase 2 safety and activity, as
well as feasibility of conducting a Phase 3 trial.
Recent FA
Data Presentations and
Publications
In September 2020, additional data analyses from
the MOXIe Part 2 study were presented at the American Academy of
Neurology’s Emerging Science conference and the FARA 2020 Biomarker
& Clinical Endpoint Meeting by Dr. David Lynch, M.D., Ph.D.
In October 2020, the results from the MOXIe Part 2
study evaluating the efficacy and safety of omaveloxolone in
patients with FA were published in the journal Annals of
Neurology.
Third Quarter Financial
Highlights
Cash and Cash Equivalents
At September 30, 2020, we had cash and cash
equivalents of $578.3 million.
Collaboration Revenue
Collaboration revenue was $1.4 million in the third
quarter of 2020, as compared to $8.2 million for the same period of
the year prior. Collaboration revenue was $5.8 million for the
nine-month period ended September 30, 2020, as compared to $23.8
million for the same period of the year prior.
GAAP and Non-GAAP Research and Development
(“R&D”) Expenses
R&D expenses according to generally accepted
accounting principles in the U.S. (“GAAP”) were $37.2 million for
the third quarter of 2020, as compared to $32.3 million for the
same period of the year prior.
Non-GAAP R&D expenses were $32.9 million for
the third quarter of 2020, as compared to $30.4 million for the
same period of the year prior.1
GAAP and Non-GAAP General and Administrative
(“G&A”) Expenses
GAAP G&A expenses were $18.3 million for the
third quarter of 2020, as compared to $14.3 million for the same
period of the year prior.
Non-GAAP G&A expenses were $11.0 million for
the third quarter of 2020, as compared to $10.8 million for the
same period of the year prior.1
GAAP and Non-GAAP Net Loss
The GAAP net loss for the third quarter of 2020 was
$65.5 million, or $1.94 per share, on both a basic and diluted
basis, as compared to a GAAP net loss of $39.7 million, or $1.32
per share, on both a basic and diluted basis, for the same period
of the year prior.
The increase in GAAP net loss for the third quarter
of 2020 is driven primarily by decreased Collaboration Revenue
related to AbbVie since the reacquisition of our licensing rights,
increased research and development expenses due to manufacturing,
preclinical, and regulatory activities, increased personnel and
stock-based compensation costs to support the growth in our
development activities, and non-cash interest expense recognized
under our liability related to sale of future royalties.
The non-GAAP net loss for the third quarter of 2020
was $44.3 million, or $1.31 per share on both a basic and diluted
basis, as compared to a non-GAAP net loss of $34.3 million, or
$1.14 per share, on both a basic and diluted basis, for the same
period of the year prior.1
Reiterates Cash Guidance
The Company reiterated that it expects existing
cash and cash equivalents will be sufficient to enable it to fund
operations through the end of 2023.
__________________
1 See “Use of Non-GAAP Financial Measures” below
for a description of non-GAAP financial measures and a
reconciliation between GAAP and non-GAAP R&D expenses, GAAP and
non-GAAP G&A expenses, and GAAP and non-GAAP net loss,
respectively, appearing later in the press release.
Non-GAAP Financial Measures
This press release contains non-GAAP financial
measures, including non-GAAP R&D expenses, non-GAAP G&A
expenses, non-GAAP operating expenses, non-GAAP net loss and
non-GAAP net loss per common share – basic and diluted. These
measures are not in accordance with, or an alternative to, GAAP,
and may be different from non-GAAP financial measures used by other
companies.
The Company defines non-GAAP R&D expenses as
GAAP R&D expenses less stock-based compensation expense;
non-GAAP G&A expenses as GAAP G&A expenses less stock-based
compensation expense; non-GAAP operating expenses as GAAP operating
expenses less stock-based compensation expense; non-GAAP net loss
as GAAP net loss plus stock-based compensation expense, loss on
extinguishment of debt, and non-cash interest expense from
liability related to sale of future royalties less gain on lease
termination; and non-GAAP net loss per common share – basic and
diluted as GAAP net loss per common share – basic and diluted plus
stock-based compensation expense, loss on extinguishment of debt,
and non-cash interest expense from liability related to sale of
future royalties less gain on lease termination. During the three
and nine months ended September 30, 2020 and 2019, the Company did
not incur any reacquired license rights expense; therefore, this
expense is not included in the reconciliations below for the
measures for non-GAAP operating expenses, non-GAAP net loss, and
non-GAAP net loss per common share – basic and diluted for these
periods. The Company has excluded the impact of stock-based
compensation expense, which may fluctuate from period to period
based on factors including the variability associated with
performance-based grants for stock options and restricted stock
units and changes in the Company’s stock price, which impacts the
fair value of these awards. The Company has excluded the impact of
loss on extinguishment of debt in connection with the Term Loan
payoff and gain on lease termination as they are non-recurring
transactions, that make it difficult to compare its results to peer
companies who also provide non-GAAP disclosures. The Company has
excluded the impact of accreted non-cash interest expense from
liability related to sale of future royalties as it may be
calculated differently from, and therefore may not be comparable
to, peer companies who also provide non-GAAP disclosures. The
Company has excluded the impact of stock-based compensation
expense, loss on extinguishment of debt, non-cash interest expense
from liability related to sale of future royalties, gain on lease
termination, and reacquired license rights expense because the
Company believes its impact makes it difficult to compare its
results to prior periods and anticipated future periods.
Because management believes certain items, such as
stock-based compensation expense, loss on extinguishment of debt,
non-cash interest expense from liability related to sales of future
royalties, gain on lease termination, and reacquired license rights
expense can distort the trends associated with the Company’s
ongoing performance, the following measures are often provided,
excluding special items, and utilized by the Company’s management,
analysts, and investors to enhance consistency and comparability of
year-over-year results, as well as to industry trends, and to
provide a basis for evaluating operating results in future periods:
non-GAAP net loss; non-GAAP net loss per common share – basic and
diluted; non-GAAP R&D expenses; non-GAAP G&A expenses; and
non-GAAP operating expenses.
The Company believes the presentation of these
non-GAAP financial measures provides useful information to
management and investors regarding the Company’s financial
condition and results of operations. When GAAP financial measures
are viewed in conjunction with these non-GAAP financial measures,
investors are provided with a more meaningful understanding of the
Company’s ongoing operating performance and are better able to
compare the Company’s performance between periods. In addition,
these non-GAAP financial measures are among those indicators the
Company uses as a basis for evaluating performance, allocating
resources and planning and forecasting future periods. These
non-GAAP financial measures are not intended to be considered in
isolation or as a substitute for GAAP financial measures. A
reconciliation between these non-GAAP measures and the most
directly comparable GAAP measures is provided later in this press
release.
Conference Call Information
Reata’s management will host a conference call on
November 9, 2020 at 8:00 a.m. ET. The conference call will be
accessible by dialing (844) 348-3946 (toll-free domestic) or (213)
358-0892 (international) using the access code: 2896858. The
webcast link is https://edge.media-server.com/mmc/p/z6fgbcwf.
Third quarter 2020 financial results to be
discussed during the call will be included in an earnings press
release that will be available on the Company’s website shortly
before the call at http://reatapharma.com/investors/ and will be
available for 12 months after the call. The audio recording and
webcast will be accessible for at least 90 days after the event at
http://reatapharma.com/investors/.
About the Off-Treatment
eGFR Endpoint
CKD is characterized by a progressive worsening in
the rate at which the kidney filters waste products from the blood
called the glomerular filtration rate or GFR. When GFR falls too
low, patients require dialysis or a kidney transplant to survive.
Dialysis leads to a reduced quality of life and increases the
likelihood of serious and life-threatening complications. The
five-year survival rate for hemodialysis patients is only
approximately 42%. eGFR is an estimate of GFR that nephrologists
use to track the decline in kidney function and progression of
CKD.
In rare forms of CKD, the FDA has accepted the
off-treatment endpoint as the basis for approval. Withdrawal of
drug after long-term treatment provides evidence whether a drug
either protected or harmed the kidney during treatment. If
off-treatment changes in eGFR are higher than placebo, this is
evidence that the drug protected the kidney during treatment, and,
if off-treatment changes in eGFR are lower than placebo, this is
evidence that the drug harmed the kidney during treatment. An
off-treatment eGFR benefit relative to placebo provides evidence
that drug treatment may delay kidney failure.
About Alport Syndrome
Alport syndrome is a rare, genetic form of CKD
caused by mutations in the genes encoding type IV collagen, which
is a major structural component of the glomerular basement membrane
in the kidney. The kidneys of patients with Alport syndrome
progressively lose the capacity to filter waste products out of the
blood, which can lead to end-stage kidney disease and the need for
chronic dialysis treatment or a kidney transplant. Alport syndrome
affects both children and adults. In patients with the most severe
forms of the disease, approximately 50% progress to dialysis by age
25, 90% by age 40, and nearly 100% by age 60. According to the
Alport Syndrome Foundation, Alport syndrome affects approximately
30,000 to 60,000 people in the United States. There are currently
no approved therapies to treat CKD caused by Alport syndrome.
About Bardoxolone Methyl
Bardoxolone methyl is an investigational, oral,
once-daily activator of Nrf2, a transcription factor that induces
molecular pathways that promote the resolution of inflammation by
restoring mitochondrial function, reducing oxidative stress, and
inhibiting pro-inflammatory signaling. The FDA has granted Orphan
Drug designation to bardoxolone for the treatment of Alport
syndrome. The European Commission has granted Orphan Drug
designation in Europe to bardoxolone for the treatment of Alport
syndrome.
In addition to the CARDINAL Phase 3 study,
bardoxolone is currently being studied in FALCON, a Phase 3 study
for the treatment of autosomal dominant polycystic kidney disease,
AYAME, a Phase 3 study for the treatment of diabetic kidney disease
that is being conducted by our licensee, Kyowa Kirin Co., Ltd., in
Japan, and BARCONA, an investigator-sponsored Phase 2 study for the
treatment in patients suffering from COVID-19 conducted by
researchers at NYU Grossman School of Medicine. Bardoxolone
treatment has produced positive results in Phase 2 studies in
patients with IgA nephropathy, focal segmental glomerulosclerosis,
and CKD associated with type 1 diabetes.
About Friedreich’s Ataxia
FA is a rare, inherited, life-shortening,
debilitating, and degenerative neuromuscular disorder, which is
normally diagnosed during adolescence. FA is typically caused by a
trinucleotide repeat expansion in the first intron of the frataxin
gene, which encodes the mitochondrial protein frataxin. Pathogenic
repeat expansions can lead to impaired transcription and reduced
frataxin expression, which can lead to mitochondrial iron overload
and poor cellular iron regulation, increased sensitivity to
oxidative stress, and impaired mitochondrial ATP production.
Patients with FA experience initial symptoms in childhood,
including progressive loss of coordination, muscle weakness, and
fatigue, commonly resulting in motor incapacitation, with patients
requiring a wheelchair by their teens or early 20s. FA patients may
also experience visual impairment, hearing loss, diabetes, and
cardiomyopathy. Based on literature and proprietary research, we
believe FA affects approximately 5,000 children and adults in the
United States and 22,000 individuals globally. There are currently
no approved therapies for the treatment of FA.
About Omaveloxolone
Omaveloxolone is an investigational, oral,
once-daily activator of Nrf2, a transcription factor that induces
molecular pathways that promote the resolution of inflammation by
restoring mitochondrial function, reducing oxidative stress, and
inhibiting pro-inflammatory signaling. The FDA has granted Orphan
Drug designation to omaveloxolone for the treatment of Friedreich’s
ataxia. The European Commission has granted Orphan Drug designation
in Europe to omaveloxolone for the treatment of Friedreich’s
ataxia.
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 the resolution of inflammation by restoring mitochondrial
function, reducing oxidative stress, and inhibiting
pro-inflammatory signaling. Bardoxolone and omaveloxolone
are investigational drugs, and their safety and efficacy have not
been established by any regulatory
agency.
Contact:Reata Pharmaceuticals,
Inc.(972) 865-2219http://reatapharma.com
Investors Relations &
Media:Vinny Jindal (469) 374-8721Jami
Taylor (469)
262-6451ir@reatapharma.commedia@reatapharma.comhttp://reatapharma.com/contact-us/
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, our
plans to submit regulatory filings, 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) whether
regulatory authorities determine that additional trials or data are
necessary in order to obtain approval; (iv) 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 (v) other factors set
forth in Reata’s filings with the U.S. Securities and Exchange
Commission, including the detailed factors discussed under the
caption “Risk Factors” in its Annual Report on Form 10-K for the
fiscal year ended December 31, 2019. 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.
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
Consolidated Statements
of Operations |
|
(unaudited) |
|
|
|
(in thousands, except share and per share
data) |
|
Collaboration revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License and milestone |
|
$ |
1,182 |
|
|
$ |
7,898 |
|
|
$ |
3,519 |
|
|
$ |
23,437 |
|
Other revenue |
|
|
219 |
|
|
|
344 |
|
|
|
2,308 |
|
|
|
409 |
|
Total collaboration
revenue |
|
|
1,401 |
|
|
|
8,242 |
|
|
|
5,827 |
|
|
|
23,846 |
|
Expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
37,183 |
|
|
|
32,279 |
|
|
|
121,620 |
|
|
|
87,948 |
|
General and administrative |
|
|
18,314 |
|
|
|
14,283 |
|
|
|
55,701 |
|
|
|
36,027 |
|
Depreciation |
|
|
289 |
|
|
|
258 |
|
|
|
851 |
|
|
|
659 |
|
Total expenses |
|
|
55,786 |
|
|
|
46,820 |
|
|
|
178,172 |
|
|
|
124,634 |
|
Other income
(expense), net |
|
|
(11,164 |
) |
|
|
(1,078 |
) |
|
|
(31,967 |
) |
|
|
(2,380 |
) |
Loss before taxes on
income |
|
|
(65,549 |
) |
|
|
(39,656 |
) |
|
|
(204,312 |
) |
|
|
(103,168 |
) |
Benefit from (provision for) taxes on income |
|
|
93 |
|
|
|
(38 |
) |
|
|
22,336 |
|
|
|
(60 |
) |
Net loss |
|
$ |
(65,456 |
) |
|
$ |
(39,694 |
) |
|
$ |
(181,976 |
) |
|
$ |
(103,228 |
) |
Net loss per share—basic and
diluted |
|
$ |
(1.94 |
) |
|
$ |
(1.32 |
) |
|
$ |
(5.45 |
) |
|
$ |
(3.44 |
) |
Weighted-average number of
common shares used in net loss per share basic and diluted |
|
|
33,713,507 |
|
|
|
30,110,391 |
|
|
|
33,401,599 |
|
|
|
30,004,211 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As ofSeptember 30,
2020(unaudited) |
|
|
As ofDecember 31, 2019 |
|
|
|
(in thousands) |
|
Condensed Consolidated Balance Sheet Data |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
578,263 |
|
|
$ |
664,324 |
|
Working capital |
|
|
560,270 |
|
|
|
477,262 |
|
Total assets |
|
|
612,997 |
|
|
|
682,420 |
|
Term loan (including current
portion, net of issuance cost) |
|
|
- |
|
|
|
155,017 |
|
Liability related to sale of
future royalties, net |
|
|
304,663 |
|
|
|
- |
|
Payable to collaborators |
|
|
71,726 |
|
|
|
216,862 |
|
Deferred revenue (including
current portion) |
|
|
5,870 |
|
|
|
9,389 |
|
Accumulated deficit |
|
|
(892,469 |
) |
|
|
(710,493 |
) |
Total stockholders’
equity |
|
$ |
185,844 |
|
|
$ |
256,857 |
|
Reconciliation of GAAP to
Non-GAAP Financial Measures
The following table presents reconciliations of
non-GAAP financial measures to the most directly comparable GAAP
financial measures (in thousands, except for per share data)
(unaudited):
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
|
September 30, |
|
|
September 30, |
|
|
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
Reconciliation of GAAP to Non-GAAP Research and
development: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP Research and
development |
|
|
$ |
37,183 |
|
|
$ |
32,279 |
|
|
$ |
121,620 |
|
|
$ |
87,948 |
|
Less: Stock-based compensation expense |
|
|
|
(4,279 |
) |
|
|
(1,885 |
) |
|
|
(23,322 |
) |
|
|
(5,235 |
) |
Non-GAAP Research and
development |
|
|
$ |
32,904 |
|
|
$ |
30,394 |
|
|
$ |
98,298 |
|
|
$ |
82,713 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reconciliation of GAAP
to Non-GAAP General and administrative: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP General and
administrative |
|
|
$ |
18,314 |
|
|
$ |
14,283 |
|
|
$ |
55,701 |
|
|
$ |
36,027 |
|
Less: Stock-based compensation expense |
|
|
|
(7,301 |
) |
|
|
(3,495 |
) |
|
|
(22,362 |
) |
|
|
(8,855 |
) |
Non-GAAP General and
administrative |
|
|
$ |
11,013 |
|
|
$ |
10,788 |
|
|
$ |
33,339 |
|
|
$ |
27,172 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reconciliation of GAAP
to Non-GAAP Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP Operating expenses |
|
|
$ |
55,786 |
|
|
$ |
46,820 |
|
|
$ |
178,172 |
|
|
$ |
124,634 |
|
Less: Stock-based compensation expense |
|
|
|
(11,580 |
) |
|
|
(5,380 |
) |
|
|
(45,684 |
) |
|
|
(14,090 |
) |
Non-GAAP Operating expenses |
|
|
$ |
44,206 |
|
|
$ |
41,440 |
|
|
$ |
132,488 |
|
|
$ |
110,544 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reconciliation of GAAP
to Non-GAAP Net loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP Net loss |
|
|
$ |
(65,456 |
) |
|
$ |
(39,694 |
) |
|
$ |
(181,976 |
) |
|
$ |
(103,228 |
) |
Add: Stock-based compensation expense |
|
|
|
11,580 |
|
|
|
5,380 |
|
|
|
45,684 |
|
|
|
14,090 |
|
Add: Non-cash interest expense from liability related to sale of
future royalties |
|
|
|
10,413 |
|
|
|
- |
|
|
|
11,077 |
|
|
|
- |
|
Add: Loss on extinguishment of debt |
|
|
|
- |
|
|
|
- |
|
|
|
11,183 |
|
|
|
- |
|
Less: Gain on lease termination |
|
|
|
(816 |
) |
|
|
- |
|
|
|
(816 |
) |
|
|
- |
|
Non-GAAP Net loss |
|
|
$ |
(44,279 |
) |
|
$ |
(34,314 |
) |
|
$ |
(114,848 |
) |
|
$ |
(89,138 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reconciliation of GAAP
to Non-GAAP Net loss per common share-basic and
diluted: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP Net loss per common
share-basic and diluted |
|
|
$ |
(1.94 |
) |
|
$ |
(1.32 |
) |
|
$ |
(5.45 |
) |
|
$ |
(3.44 |
) |
Add: Stock-based compensation expense |
|
|
|
0.34 |
|
|
|
0.18 |
|
|
|
1.37 |
|
|
|
0.47 |
|
Add: Non-cash interest expense from liability related to sale of
future royalties |
|
|
|
0.31 |
|
|
|
- |
|
|
|
0.33 |
|
|
|
- |
|
Add: Loss on extinguishment of debt |
|
|
|
- |
|
|
|
- |
|
|
|
0.33 |
|
|
|
- |
|
Less: Gain on lease termination |
|
|
|
(0.02 |
) |
|
|
- |
|
|
|
(0.02 |
) |
|
|
- |
|
Non-GAAP Net loss per common
share-basic and diluted |
|
|
$ |
(1.31 |
) |
|
$ |
(1.14 |
) |
|
$ |
(3.44 |
) |
|
$ |
(2.97 |
) |
|
|
Three Months Ended |
|
Reconciliation of GAAP
to Non-GAAP Operating expenses |
|
September 30, 2020 |
|
|
June 30, 2020 |
|
|
March 31, 2020 |
|
GAAP - Operating expenses |
|
$ |
55,786 |
|
|
$ |
53,667 |
|
|
$ |
68,718 |
|
Less: Stock-based compensation expense |
|
|
(11,580 |
) |
|
|
(14,796 |
) |
|
|
(19,307 |
) |
Non - GAAP - Operating
expenses |
|
$ |
44,206 |
|
|
$ |
38,871 |
|
|
$ |
49,411 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reconciliation of GAAP
to Non-GAAP Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
GAAP - Net loss |
|
$ |
(65,456 |
) |
|
$ |
(67,581 |
) |
|
$ |
(48,939 |
) |
Add: Stock-based compensation expense |
|
|
11,580 |
|
|
|
14,796 |
|
|
|
19,307 |
|
Add: Non-cash interest expense from liability related to sale of
future royalties |
|
|
10,413 |
|
|
|
664 |
|
|
|
- |
|
Add: Loss on extinguishment of debt |
|
|
- |
|
|
|
11,183 |
|
|
|
- |
|
Less: Gain on lease termination |
|
|
(816 |
) |
|
|
- |
|
|
|
- |
|
Non-GAAP Net
loss |
|
$ |
(44,279 |
) |
|
$ |
(40,938 |
) |
|
$ |
(29,632 |
) |
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