ChemoCentryx Reports Second Quarter 2020 Financial Results and Recent Highlights
August 10 2020 - 4:05PM
ChemoCentryx, Inc. (Nasdaq: CCXI) today announced financial results
for the second quarter ended June 30, 2020 and provided
an overview of the Company's recent corporate highlights.
"A major milestone was accomplished recently with the filing of
the NDA for avacopan for the treatment of ANCA-associated
vasculitis with the U.S. FDA,” said Thomas J. Schall, Ph.D.,
President and Chief Executive Officer of ChemoCentryx. “This is one
more crucial step toward achieving our unwavering goal of changing
the treatment paradigm for people now enduring this
organ-threatening and life-endangering disease. ANCA vasculitis
patients have waited too long for new therapy; it is our goal to
make sure that wait is not in vain.”
“We are also ever closer to realizing avacopan’s potential as a
pipeline-in-a-drug with upcoming readouts in HS and C3G expected
later this year. We will not stop there. The innovation seen in
such new pipeline assets as CCX559, our novel orally administered
checkpoint inhibitor for next generation cancer treatment, has real
potential to fuel future growth and create significant value. I
believe that we are poised to achieve our ultimate mission to be a
fully integrated and self-sustaining enterprise that provides
better therapies for previously neglected, underserved patient
needs. And the $325.7 million in net proceeds from our successful
June equity follow-on offering, coupled with our already healthy
cash reserves, provides the capital to get us there.”
Key Highlights
- Filed the New Drug Application (NDA) for avacopan in the
treatment of ANCA-associated vasculitis in July. The Company’s NDA
submission is supported by the results of its pivotal Phase III
ADVOCATE trial, which demonstrated statistical superiority in
sustaining remission at 52 weeks in the avacopan group compared to
the prednisone group. In the trial, the avacopan group also showed
significantly lower glucocorticoid toxicity, greater improvement in
kidney function and greater improvement in health-related quality
of life measures compared to the prednisone group. Finally,
avacopan demonstrated favorable safety results in this serious and
life-threatening disease, with fewer subjects having serious
adverse events in the avacopan group than in the prednisone
group.
- Presented additional data from the ADVOCATE trial were selected
for oral plenary presentations in June at the leading European
rheumatology and nephrology
conferences: EULAR (European League Against
Rheumatism) and ERA-EDTA (European Renal
Association - European Dialysis and Transplant
Association).
- Presented data at the American Association for Cancer Research
(AACR) meeting in June, demonstrating that the Company’s orally
administered checkpoint inhibitors led to marked inhibition of
PD-1/PD-L1 interaction and signaling in vitro and potent anti-tumor
effects in animal models. The Company has identified its orally
administered checkpoint inhibitor, CCX559, as a candidate for next
generation cancer treatment and plans to initiate clinical studies
in the first half of 2021.
- Completed enrollment in May 2020 of more than 400 patients in
the Company’s AURORA Phase IIb clinical trial of avacopan for the
treatment of the chronic disabling skin disease Hidradenitis
Suppurativa (HS). Topline data from AURORA are now expected early
in the fourth quarter of 2020, a modest delay caused by the
resurgence of COVID-19 impacting certain sites where we have been
conducting this trial.
- Strengthened the balance sheet with $325.7 million in net
proceeds from a successful equity follow-on offering, including
full exercise of the underwriters’ option to purchase additional
shares. Proceeds from the offering will be used to support the
anticipated commercial launch of avacopan in ANCA vasculitis;
avacopan lifecycle management, including expansion into additional
indications and formulation development; and development of
additional drug candidates, including CCX559.
- Reported cash, cash equivalents and investments exceeded $504.6
million at June 30, 2020.
Second Quarter 2020 Financial Results
Revenue was $49.4 million for the second quarter of 2020,
compared to $7.2 million for the same period in 2019. The increase
in total revenue from 2019 to 2020 was primarily due to the
acceleration of revenue recognition associated with the CCX140
agreement with Vifor. Following the decision to discontinue
development of CCX140 in FSGS, $46.7 million of deferred revenue
was recognized as contract revenue. This increase was partially
offset by lower costs incurred due to the completion of the
avacopan ADVOCATE Phase III pivotal trial in 2020.
Research and development expenses were $18.8 million for the
second quarter of 2020, compared to $17.6 million for the same
period in 2019. The increase from 2019 to 2020 was primarily
attributable to the completion of patient enrollment of the
avacopan AURORA Phase IIb clinical trial in patients with HS,
professional fees associated with the preparation of our NDA
submission for avacopan for the treatment of ANCA vasculitis and
higher research and drug discovery expenses, including those tied
to the advancement of CCX559, the Company’s orally administered
checkpoint inhibitor. These increases were partially offset by
lower expenses due to the completion of the avacopan ADVOCATE Phase
III pivotal trial in 2020 and the CCX140 LUMINA-1 Phase II clinical
trial in 2019.
General and administrative expenses were $10.3 million for the
second quarter of 2020, compared to $5.6 million for the same
period in 2019. The increase from 2019 to 2020 was primarily due to
higher employee-related expenses, including those associated with
our commercialization planning efforts, and higher professional
fees.
Net income for the second quarter of 2020 was $20.3 million,
compared to net loss of $15.2 million for the same period in
2019.
Total shares outstanding at June 30, 2020 were approximately
68.8 million shares.
Cash, cash equivalents and investments totaled $504.6 million at
June 30, 2020, including the $325.7 million in net proceeds from
the June 2020 equity follow-on offering of common stock.
Conference Call and Webcast
The Company will host a conference call and webcast today,
August 10, 2020 at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time.
To participate by telephone, please dial (877) 303-8028 (Domestic)
or (760) 536-5167 (International). The conference ID number is
6246545. A live and archived audio webcast can be accessed through
the Investors section of the Company's website at
www.ChemoCentryx.com. The archived webcast will remain available on
the Company's website for fourteen (14) days following the
conference call.
About ChemoCentryx
ChemoCentryx is a biopharmaceutical company developing new
medications targeted at inflammatory and autoimmune diseases and
cancer. ChemoCentryx targets the chemokine and
chemoattractant systems to discover, develop and commercialize
orally administered therapies. ChemoCentryx’s lead drug candidate,
avacopan (CCX168), successfully completed a pivotal Phase III trial
in ANCA-associated vasculitis.
ChemoCentryx also has early stage drug candidates that
target chemoattractant receptors in other inflammatory and
autoimmune diseases and in cancer.
Forward-Looking StatementsChemoCentryx cautions
that statements included in this press release that are not a
description of historical facts are forward-looking statements.
Words such as "may," "could," "will," "would," "should," "expect,"
"plan," "anticipate," "believe," "estimate," "intend," "predict,"
"seek," "contemplate," "potential," "continue" or "project" or the
negative of these terms or other comparable terminology are
intended to identify forward-looking statements. These statements
include the Company's statements regarding the timing of the FDA’s
filing decision for the Company’s NDA, the achievement of
anticipated goals and milestones, whether avacopan will be approved
by the FDA for the treatment of ANCA-associated vasculitis, whether
avacopan will be an effective treatment in other indications such
as C3G or HS, when full data analysis of LUMINA-1 and topline
LUMINA-2, AURORA and ACCOLADE clinical data might become available
or be released, whether CCX559 will enter clinical trials in the
first half of 2021, and whether the Company's drug candidates will
be shown to be effective in ongoing or future clinical trials. The
inclusion of forward-looking statements should not be regarded as a
representation by ChemoCentryx that any of its plans will be
achieved. Actual results may differ from those set forth in this
release due to the risks and uncertainties inherent in the
ChemoCentryx business and other risks described in the Company's
filings with the Securities and Exchange Commission ("SEC").
Investors are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof,
and ChemoCentryx undertakes no obligation to revise or update this
news release to reflect events or circumstances after the date
hereof. Further information regarding these and other risks is
included under the heading "Risk Factors" in ChemoCentryx's
periodic reports filed with the SEC, including ChemoCentryx's
Annual Report on Form 10-K filed with the SEC on March 10, 2020 and
its other reports which are available from the SEC's website
(www.sec.gov) and on ChemoCentryx's website (www.chemocentryx.com)
under the heading "Investors." All forward-looking statements are
qualified in their entirety by this cautionary statement. This
caution is made under the safe harbor provisions of Section 21E of
the Private Securities Litigation Reform Act of 1995.
Contacts:
Susan M. KanayaExecutive Vice President,Chief Financial and
Administrative Officerinvestor@chemocentryx.com
Media:Stephanie
Tomei408.234.1279media@chemocentryx.com
Investors:William Slattery, Jr., Burns
McClellan212.213.0006bslattery@burnsmc.com
ChemoCentryx, Inc. |
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Condensed Consolidated Financial Statements
Data |
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|
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|
(in thousands, except per share data) |
|
|
|
|
|
|
Three Months
Ended |
|
Six Months
Ended |
|
June 30, |
|
June 30, |
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
|
(unaudited) |
Condensed Consolidated Statements of Operations
Data: |
|
|
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Revenue: |
|
|
|
|
|
|
|
Collaboration and license revenue from related party |
$ |
49,283 |
|
|
$ |
7,173 |
|
|
$ |
55,138 |
|
|
$ |
15,500 |
|
Grant revenue |
|
157 |
|
|
|
- |
|
|
|
310 |
|
|
|
- |
|
Total revenue |
|
49,440 |
|
|
|
7,173 |
|
|
|
55,448 |
|
|
|
15,500 |
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and development |
|
18,762 |
|
|
|
17,624 |
|
|
|
38,073 |
|
|
|
32,978 |
|
General and administrative |
|
10,292 |
|
|
|
5,570 |
|
|
|
19,112 |
|
|
|
11,071 |
|
Total operating expenses |
|
29,054 |
|
|
|
23,194 |
|
|
|
57,185 |
|
|
|
44,049 |
|
Income
(loss) from operations |
|
20,386 |
|
|
|
(16,021 |
) |
|
|
(1,737 |
) |
|
|
(28,549 |
) |
Total other
income (loss), net |
|
(119 |
) |
|
|
871 |
|
|
|
317 |
|
|
|
1,450 |
|
Net income
(loss) |
$ |
20,267 |
|
|
$ |
(15,150 |
) |
|
$ |
(1,420 |
) |
|
$ |
(27,099 |
) |
Net income
(loss) per common share: |
|
|
|
|
|
|
|
Basic |
$ |
0.32 |
|
|
$ |
(0.26 |
) |
|
$ |
(0.02 |
) |
|
$ |
(0.49 |
) |
Diluted |
$ |
0.29 |
|
|
$ |
(0.26 |
) |
|
$ |
(0.02 |
) |
|
$ |
(0.49 |
) |
Shares used
to compute net income (loss) per common share: |
|
|
|
|
|
|
|
Basic |
|
63,282 |
|
|
|
58,056 |
|
|
|
62,289 |
|
|
|
55,226 |
|
Diluted |
|
69,416 |
|
|
|
58,056 |
|
|
|
62,289 |
|
|
|
55,226 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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June
30, |
|
December
31, |
|
|
|
|
|
|
2020 |
|
|
|
2019 |
|
|
|
|
|
|
(unaudited) |
|
|
Condensed Consolidated Balance Sheets Data: |
|
|
|
|
|
|
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Cash, cash
equivalents and investments |
|
|
|
|
$ |
504,620 |
|
|
$ |
202,240 |
|
Working
capital |
|
|
|
|
|
450,868 |
|
|
|
115,282 |
|
Total
assets |
|
|
|
|
|
542,044 |
|
|
|
209,083 |
|
Long-term
debt, net |
|
|
|
|
|
24,252 |
|
|
|
19,786 |
|
Accumulated
deficit |
|
|
|
|
|
(431,406 |
) |
|
|
(429,986 |
) |
Total
stockholders’ equity |
|
|
|
|
|
421,141 |
|
|
|
66,000 |
|
|
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