ChemoCentryx Reports Third Quarter 2020 Financial Results and Recent Highlights
November 09 2020 - 4:05PM
ChemoCentryx, Inc., (Nasdaq: CCXI), today announced financial
results for the third quarter ended September 30,
2020 and provided an overview of the Company's recent
corporate highlights.
"A powerful current of progress propels our enterprise, as
exemplified by the recent FDA acceptance for review of our NDA for
avacopan for the treatment of ANCA-associated vasculitis,” said
Thomas J. Schall, Ph.D., President and Chief Executive Officer of
ChemoCentryx. “We ready ourselves for the bright prospect of
changing the treatment paradigm in ANCA vasculitis, while also
pursuing the rest of our avacopan pipeline-in-a-drug strategy. To
that end, we expect to announce topline data from avacopan in C3G
by the end of this year, and we are also on track to start clinical
development of avacopan in lupus nephritis and initiate a pivotal
Phase III trial of avacopan in patients with severe hidradenitis
suppurativa in 2021. Beyond that -- let’s not forget -- our
orally-administered small molecule checkpoint inhibitor CCX559,
designed to be a next generation cancer treatment, is also slated
to enter the clinic in the first half of 2021.”
Dr. Schall continued, “The marked progress that we have
generated in recent quarters at ChemoCentryx continues to drive us
toward our goal of becoming a fully-integrated company that
provides new kinds of therapies for the most critical diseases.
History shows that our unique discovery and development platform
has generated not just avacopan but multiple drug candidates for
the highest need indications. We will always follow where the
science leads, continuing to focus on the areas of the greatest
need and greatest promise for patients, and also with the greatest
potential reward for our shareholders.”
Key Highlights
- In September, the FDA accepted for
review the Company’s New Drug Application (NDA) for avacopan in the
treatment of ANCA-associated vasculitis and set July 7,
2021 as the Prescription Drug User Fee Act (PDUFA) goal date.
The NDA included data from the global, Phase III ADVOCATE
trial.
- In November, the Company’s Kidney
Health Alliance partner Vifor Fresenius Medical Care Renal Pharma
announced that their marketing authorization application (MAA) for
avacopan in the treatment of ANCA-associated vasculitis has been
validated by the European Medicines Agency (EMA). Approval is
expected in the second half of 2021.
- The results of the Phase III
ADVOCATE trial of avacopan for the treatment of ANCA-Associated
Vasculitis were shared in oral presentations at Kidney Week 2020,
the annual meeting of the American Society of Nephrology (ASN), and
ACR Convergence 2020, the annual meeting of the American College of
Rheumatology (ACR).
- In October, the Company announced
topline data from the randomized, double-blind, placebo-controlled,
multi-center Phase II AURORA clinical trial of avacopan for the
treatment of the chronic disabling skin disease Hidradenitis
Suppurativa (HS) in patients with moderate or severe disease.
Avacopan at 30 mg BID demonstrated a statistically significant
higher response than placebo in the pre-specified Hurley Stage III
(severe) HS patients and the Company plans to advance avacopan into
Phase III development for the treatment of severe HS.
- The Company expects to announce
topline data from the ACCOLADE trial of avacopan for patients with
C3 Glomerulopathy (C3G) by year end 2020.
- The Company remains on track to
initiate clinical studies of avacopan in lupus nephritis and its
orally administered checkpoint inhibitor, CCX559, for cancer in the
first half of 2021.
Third Quarter
2020 Financial Results
Revenue was $5.1 million for the third quarter of 2020, compared
to $10.6 million for the same period in 2019. Revenue is recognized
based on actual costs incurred as a percentage of total budgeted
costs as the Company completes its performance obligations under
its alliance agreements. The decrease from 2019 to 2020 was
primarily attributable to lower costs incurred in 2020 due to the
completion of the avacopan ADVOCATE Phase III pivotal trial.
Research and development expenses were $18.6 million for the
third quarter of 2020, compared to $18.1 million for the same
period in 2019. The increase from 2019 to 2020 was primarily
attributable to professional fees associated with the preparation
of the 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 and the CCX140 LUMINA-1
Phase II clinical trial in 2019.
General and administrative expenses were $10.4 million for the
third quarter of 2020, compared to $6.1 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 loss for the third quarter of 2020 was $24.1 million,
compared to net loss of $12.9 million for the same period in
2019.
Total shares outstanding at September 30, 2020 were
approximately 69.1 million shares.
Cash, cash equivalents and investments totaled $485.8 million at
September 30, 2020 and the Company projects to end 2020 with cash
and investments in excess of $460 million.
Conference Call and Webcast
The Company will host a conference call and webcast today,
November 9, 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 7147318. 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 for 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 and a New Drug Application is under
review by the U.S. Food and Drug Administration. Avacopan is also
in late stage clinical development for the treatment of
Hidradenitis Suppurativa and C3 glomerulopathy (C3G).
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 achievement of
anticipated goals and milestones, whether avacopan will be approved
by the FDA and EMA for the treatment of ANCA-associated vasculitis,
the timing of the FDA’s and EMA’s decision on the NDA and MAA,
whether avacopan will be an effective treatment in other
indications such HS and C3G, when full data analysis of AURORA and
ACCOLADE clinical data might become available or be released,
whether a Phase III trial of avacopan in patients with HS will
commence in 2021, whether avacopan for lupus nephritis and CCX559
will enter clinical trials in the first half of 2021, whether
actual year-end 2020 cash and investments are within projections
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:Burns McClellanSteve
Klass212.213.0006 sklass@burnsmc.com
ChemoCentryx, Inc. |
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Condensed Consolidated Financial Statements
Data |
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(in thousands, except per share data) |
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Three Months
Ended |
|
Nine Months
Ended |
|
September 30, |
|
September 30, |
|
|
2020 |
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2019 |
|
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|
2020 |
|
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|
2019 |
|
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|
|
|
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|
|
|
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|
|
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(unaudited) |
Condensed Consolidated Statements of Operations
Data: |
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Revenue: |
|
|
|
|
|
|
|
Collaboration and license revenue from related party |
$ |
5,027 |
|
|
$ |
10,581 |
|
|
$ |
60,165 |
|
|
$ |
26,081 |
|
Grant revenue |
|
58 |
|
|
|
- |
|
|
|
368 |
|
|
|
- |
|
Total revenue |
|
5,085 |
|
|
|
10,581 |
|
|
|
60,533 |
|
|
|
26,081 |
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and development |
|
18,582 |
|
|
|
18,096 |
|
|
|
56,655 |
|
|
|
51,074 |
|
General and administrative |
|
10,362 |
|
|
|
6,116 |
|
|
|
29,474 |
|
|
|
17,187 |
|
Total operating expenses |
|
28,944 |
|
|
|
24,212 |
|
|
|
86,129 |
|
|
|
68,261 |
|
Loss from
operations |
|
(23,859 |
) |
|
|
(13,631 |
) |
|
|
(25,596 |
) |
|
|
(42,180 |
) |
Total other
income (expense), net |
|
(201 |
) |
|
|
769 |
|
|
|
116 |
|
|
|
2,219 |
|
Net
loss |
$ |
(24,060 |
) |
|
$ |
(12,862 |
) |
|
$ |
(25,480 |
) |
|
$ |
(39,961 |
) |
|
|
|
|
|
|
|
|
Basic and
diluted net loss per common share |
$ |
(0.35 |
) |
|
$ |
(0.22 |
) |
|
$ |
(0.40 |
) |
|
$ |
(0.71 |
) |
|
|
|
|
|
|
|
|
Shares used
to compute basic and diluted net loss per common share |
|
68,922 |
|
|
|
58,205 |
|
|
|
64,500 |
|
|
|
56,219 |
|
|
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September
30, |
|
December
31, |
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2020 |
|
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2019 |
|
|
|
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(unaudited) |
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Condensed Consolidated Balance Sheets Data: |
|
|
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Cash, cash
equivalents and investments |
|
|
|
|
$ |
485,840 |
|
|
$ |
202,240 |
|
Working
capital |
|
|
|
|
|
427,580 |
|
|
|
115,282 |
|
Total
assets |
|
|
|
|
|
533,042 |
|
|
|
209,083 |
|
Long-term
debt, net |
|
|
|
|
|
24,326 |
|
|
|
19,786 |
|
Accumulated
deficit |
|
|
|
|
|
(455,466 |
) |
|
|
(429,986 |
) |
Total
stockholders’ equity |
|
|
|
|
|
404,819 |
|
|
|
66,000 |
|
|
|
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