ChemoCentryx, Inc., (Nasdaq: CCXI), today announced financial
results for the fourth quarter and full year ended December
31, 2020 and provided an overview of recent corporate
highlights.
"Inexorably our march of progress advances, drummed on by the
call to improve the lives of patients enduring diseases with
grossly inadequate treatments,” said Thomas J. Schall, Ph.D.,
President and Chief Executive Officer of ChemoCentryx. “With
regulatory applications for avacopan in ANCA-associated vasculitis
accepted for review on three continents, we are preparing for our
first commercial launch. In my view, avacopan has the potential to
transform the lives of patients suffering from debilitating and
intractable diseases, as demonstrated by the results not just in
ANCA-associated vasculitis but also from our clinical trials in HS
and C3G. We plan to launch a Phase III trial of avacopan in
patients with severe HS in 2021, and to discuss the regulatory
pathway for avacopan in C3G. Meanwhile, we are on track to initiate
our next cycle of clinical development in 2021, with avacopan in
lupus nephritis and – breaking entirely new ground - our
orally-administered small molecule checkpoint inhibitor CCX559,
designed to be a next generation cancer treatment. We sense at
ChemoCentryx the opportunity to transform the therapeutic landscape
to the benefit of patients – and we intend to seize it.”
Key Fourth Quarter 2020 Highlights and Recent
Developments
- In February, The New England Journal
of Medicine (NEJM) published the results of the Company’s Phase III
ADVOCATE trial of avacopan in ANCA-associated vasculitis, in which
avacopan achieved statistical superiority in sustained remission at
52 weeks over prednisone containing standard of care.
- The article also reported additional
benefits of avacopan including significantly lower risk of relapse,
enhanced renal function, decreased toxicities related to
glucocorticoids, and improved quality of life.
- The avacopan article was accompanied
by an editorial in the NEJM entitled “Avacopan – Time to Replace
Glucocorticoids?” By Dr. Kenneth J. Warrington, Chair in the
Division of Rheumatology, Department of Internal Medicine at Mayo
Clinic in Rochester, Minn.
- In February, the
Company announced the appointment of Tausif “Tosh” Butt as
Executive Vice President, Chief Operating Officer. Mr. Butt brings
more than 20 years of executive management expertise in roles
including sales and marketing with global pharmaceutical companies
such as AstraZeneca, GlaxoSmithKline and Sanofi.
- In December, the Company announced
topline data from the ACCOLADE trial of avacopan for patients with
the very rare disorder known as C3 Glomerulopathy (C3G). As in ANCA
vasculitis, avacopan demonstrated statistically significant
improvement in renal function as measured by the pre-specified
endpoint of eGFR compared to placebo over 26 weeks of blinded
treatment. While the change from baseline to Week 26 in C3
Glomerulopathy Histologic Index (C3G HI) Disease Activity score
(primary endpoint) was improved with avacopan but not statistically
different between the two treatment groups, the pre-specified
secondary histology endpoint of C3G HI Disease Chronicity score
(measuring progression of fibrosis) did demonstrate statistically
significant benefit for avacopan over placebo. Avacopan was safe
and well tolerated in C3G patients. Based on these data,
ChemoCentryx plans to discuss evidence of clinical benefit for
avacopan in C3G, for which there are no approved therapies, with
the FDA.
- The marketing authorization
application for avacopan in the treatment of ANCA-associated
vasculitis was validated by the European Medicines Agency (EMA) in
November, and very recently (February) the Japanese New Drug
Application was accepted for review by the Pharmaceuticals and
Medical Devices Agency (PMDA).
- In October, ChemoCentryx reported
topline data from AURORA, the randomized, double-blind,
placebo-controlled, multi-center Phase II clinical trial of
avacopan for the treatment of 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 in this patient population.
- The Company remains on track to
initiate Phase I clinical development of its orally administered
checkpoint inhibitor, CCX559, for cancer in the first half of 2021,
and a clinical study of avacopan in lupus nephritis in the third
quarter of 2021.
- The Company maintained a strong
balance sheet, with reported cash, cash equivalents and investments
of $460.4 million at December 31, 2020.
Fourth Quarter and Full Year 2020 Financial
Results
Revenue was $4.4 million for the fourth quarter of 2020,
compared to $10.0 million for the same period in 2019. For the full
year ended December 31, 2020, revenue was $64.9 million, compared
to $36.1 million 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 quarterly 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. The
year-over-year increase was driven by the acceleration of revenue
recognition associated with the CCX140 agreement with Vifor.
Following the decision to discontinue development of CCX140 in
focal segmental glomerulosclerosis, $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 $21.2 million for the
fourth quarter of 2020, compared to $19.2 million for the same
period in 2019. Full year 2020 research and development expenses
were $77.9 million, compared to $70.3 million in 2019. The
increases from 2019 to 2020 were 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 $12.7 million for the
fourth quarter of 2020, compared to $7.0 million for the same
period in 2019. Full year 2020 general and administrative expenses
were $42.2 million, compared to $24.2 million in 2019. The
increases from 2019 to 2020 were primarily due to higher
employee-related expenses, including those associated with our
commercialization planning efforts, and higher professional
fees.
Net loss for the fourth quarter of 2020 was $29.9 million,
compared to a net loss of $15.5 million for the same period in
2019. Full year 2020 net loss was $55.4 million, compared to a net
loss of $55.5 million in 2019.
Total shares outstanding at December 31, 2020 were approximately
69.5 million shares.
Cash, cash equivalents and investments totaled $460.4 million at
December 31, 2020. The Company expects to utilize cash, cash
equivalents and investments in the range of $145
million to $155 million in 2021.
Conference Call and Webcast
The Company will host a conference call and webcast today, March
1, 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
8283128. 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 severe
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, EMA or PMDA for the treatment of ANCA-associated
vasculitis, the timing of the FDA’s, EMA’s and PMDA’s decision on
the NDA, MAA, and JNDA, respectively, whether avacopan will be an
effective treatment in other indications such severe HS and C3G,
whether a Phase III trial of avacopan in patients with severe HS
will commence in 2021, whether avacopan for lupus nephritis and
CCX559 will enter clinical trials in 2021, whether actual cash
utilization will fall 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 1, 2021 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 McClellanLee Roth212.213.0006
lroth@burnsmc.com
|
ChemoCentryx,
Inc. |
Condensed
Consolidated Financial Statements Data |
(in thousands,
except per share data) |
|
|
Three Months
Ended |
|
Twelve
Months Ended |
|
|
December 31, |
|
December 31, |
|
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
|
|
|
|
|
|
|
|
|
(unaudited) |
|
|
|
|
Condensed Consolidated Statements of Operations
Data: |
|
|
|
|
|
|
|
|
Revenue: |
|
|
|
|
|
|
|
|
Collaboration and license revenue from related party |
|
$ |
4,227 |
|
|
$ |
9,871 |
|
|
$ |
64,392 |
|
|
$ |
35,952 |
|
Grant revenue |
|
|
131 |
|
|
|
176 |
|
|
|
499 |
|
|
|
176 |
|
Total revenue |
|
|
4,358 |
|
|
|
10,047 |
|
|
|
64,891 |
|
|
|
36,128 |
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
21,227 |
|
|
|
19,202 |
|
|
|
77,882 |
|
|
|
70,276 |
|
General and administrative |
|
|
12,712 |
|
|
|
6,968 |
|
|
|
42,186 |
|
|
|
24,155 |
|
Total operating expenses |
|
|
33,939 |
|
|
|
26,170 |
|
|
|
120,068 |
|
|
|
94,431 |
|
Loss from operations |
|
|
(29,581 |
) |
|
|
(16,123 |
) |
|
|
(55,177 |
) |
|
|
(58,303 |
) |
Other income (expense), net |
|
|
(295 |
) |
|
|
595 |
|
|
|
(179 |
) |
|
|
2,814 |
|
Net
loss |
|
$ |
(29,876 |
) |
|
$ |
(15,528 |
) |
|
$ |
(55,356 |
) |
|
$ |
(55,489 |
) |
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per common share |
|
$ |
(0.43 |
) |
|
$ |
(0.26 |
) |
|
$ |
(0.84 |
) |
|
$ |
(0.98 |
) |
|
|
|
|
|
|
|
|
|
Shares used to compute basic and diluted net loss per common
share |
|
69,253 |
|
|
|
58,938 |
|
|
|
65,688 |
|
|
|
56,898 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
|
|
|
|
2020 |
|
|
|
2019 |
|
|
|
|
|
|
|
|
|
|
Condensed Consolidated Balance Sheets Data: |
|
|
|
|
|
|
|
|
Cash, cash equivalents and investments |
|
|
|
|
|
$ |
460,370 |
|
|
$ |
202,240 |
|
Working
capital |
|
|
|
|
|
|
390,012 |
|
|
|
115,282 |
|
Total
assets |
|
|
|
|
|
|
518,899 |
|
|
|
209,083 |
|
Long-term
debt, net |
|
|
|
|
|
|
24,401 |
|
|
|
19,786 |
|
Accumulated
deficit |
|
|
|
|
|
|
(485,342 |
) |
|
|
(429,986 |
) |
Total stockholders’ equity |
|
|
|
|
|
|
385,613 |
|
|
|
66,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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