-- Expanded Vifor Pharma partnership now totals
$155 million in upfront cash commitments, $1.2 billion in potential
milestone payments, plus substantial royalties on potential net
sales --
ChemoCentryx, Inc., (Nasdaq:CCXI), a biopharmaceutical company
developing new medications targeted at inflammatory and autoimmune
diseases and cancer, today announced financial results for the
fourth quarter and full year ended December 31, 2016.
“2016 was a transformative year for ChemoCentryx,” said Thomas
J. Schall, Ph.D., President and Chief Executive Officer of
ChemoCentryx. “We are now entering the next step in our evolution,
driving the registration trials of our novel drug candidates and
preparing for their commercialization. We have established a
strong financial position through our partnership with Vifor Pharma
and are now well positioned to execute on our plan to create value
for patients and shareholders, starting with kidney disease.”
Recent Highlights
- In December 2016, ChemoCentryx launched the Phase III ADVOCATE
trial with avacopan for the treatment of ANCA-associated Vasculitis
(AAV), a devastating autoimmune disease that destroys blood vessels
and can lead to kidney failure. The design of the trial was agreed
upon with the U.S. Food and Drug Administration (FDA) and the
European Medicines Agency (EMA). ADVOCATE is a randomized,
double-blind two arm study enrolling 300 patients across 200 sites
in the United States and Europe.
- In December 2016, ChemoCentryx and Vifor Pharma announced an
expansion of their global kidney health alliance to include
CCX140. Together with the avacopan deal announced in May
2016, the partnership with Vifor Pharma brought a total of $135
million in upfront cash commitments to ChemoCentryx in 2016, with
the prospect of a further $1.2 billion in potential milestone
payments.
- In February 2017, ChemoCentryx and Vifor Pharma announced that
they had harmonized the geographic commercialization rights for
both drug candidates, with a further $20 million upfront commitment
to ChemoCentryx.
- ChemoCentryx retains the rights to commercialize avacopan and
CCX140 for orphan and rare renal diseases in the United States and
China, and will receive tiered double digit royalties on Vifor
Pharma’s net sales in other markets.
Fourth Quarter and Full Year 2016 Financial
Results
Pro forma cash, cash equivalents and investments totaled $194
million at December 31, 2016, which included the $50.0 million
upfront commitment in connection with the December 2016 CCX140
agreement and the $20.0 million upfront commitment related to the
February 2017 amendment to the avacopan agreement.
Revenue was $4.9 million for the fourth quarter, compared to
zero for the same period in 2015. For the full year ended
December 31, 2016, revenue was $11.9 million, compared to zero for
2015. The increase in revenue from 2015 to 2016 was due to: (i)
amortization of the upfront payment from Vifor Pharma pursuant to
the avacopan agreement and (ii) grant revenue from the FDA to
support the clinical development of avacopan for the treatment of
patients with AAV.
Research and development (R&D) expenses were $9.3 million
for the fourth quarter, compared to $8.2 million for the same
period in 2015. Full year 2016 R&D expenses were $38.0 million
compared to $33.2 million in 2015. The increase in R&D expenses
from 2015 to 2016 was primarily attributable to higher expenses
associated with avacopan for start-up activities and ancillary
studies related to the Phase III development program in patients
with AAV. This increase was partially offset by lower expenses
associated with Phase II development of avacopan, due to the
completion of the CLEAR and CLASSIC Phase II clinical trials in
2016.
General and administrative (G&A) expenses were $3.6 million
for the fourth quarter, compared to $3.4 million for the same
period in 2015. Full year 2016 G&A expenses were $14.7 million,
compared to $14.5 million in 2015. The increase from 2015 to 2016
was primarily due to higher professional service fees relating to
the Company’s business development efforts.
Net losses for the fourth quarter were $7.7 million, compared to
$11.6 million for the same period in 2015. Full year 2016 net
losses, at $40.0 million, were also lower than the $47.3 million
net losses in 2015.
Total shares outstanding at December 31, 2016 were approximately
48.1 million shares.
The Company expects to utilize cash and cash equivalents between
$50 million and $55 million in 2017.
Conference Call and Webcast
The Company will host a conference call and webcast today, March
14, 2017 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 80376833.
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 is currently focusing on its late stage
drug candidates for patients with rare kidney diseases, avacopan
(CCX168) and CCX140.
Avacopan is an orally-administered small molecule that is a
selective inhibitor of the complement C5a receptor, or C5aR.
Avacopan is in Phase III development for the treatment of
anti-neutrophil cytoplasmic auto-antibody-associated vasculitis
(AAV). In clinical studies to date, avacopan was shown to be safe,
well tolerated and provided effective control of the disease while
allowing elimination of high-dose steroids, part of the current
standard of care. Avacopan is also being developed in patients with
C3 glomerulopathy (C3G) and atypical hemolytic uremic syndrome
(aHUS). The U.S. Food and Drug Administration has now
granted avacopan orphan-drug designation for AAV and aHUS.
The European Commission has granted orphan medicinal
product designation for avacopan for the treatment of two forms of
AAV: microscopic polyangiitis and granulomatosis with polyangiitis
(formerly known as Wegener's granulomatosis). Avacopan was
also granted access to the European Medicines Agency's (EMA)
PRIority MEdicines (PRIME) initiative, which
supports accelerated assessment of investigational therapies
addressing unmet medical need.
The Company’s other late stage drug candidate is CCX140, an
inhibitor of the chemokine receptor known as CCR2, which is
currently being developed for patients with focal segmental
glomerulosclerosis (FSGS), a debilitating kidney disease.
ChemoCentryx’s Kidney Health Alliance with Vifor Pharma provides
Vifor Pharma with exclusive rights to commercialize avacopan and
CCX140 in markets outside of the U.S. and China.
ChemoCentryx also has early stage drug candidates that target
chemoattractant receptors in other Inflammatory and autoimmune
diseases and in cancer.
Forward-Looking Statements
ChemoCentryx 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 the Company's alliance with Vifor Pharma will
provide milestone payments and royalties on international sales 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 14, 2017 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.
Source: ChemoCentryx, Inc.
CCXI-G
ChemoCentryx, Inc. |
|
Consolidated Statement of Operations Data |
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(in thousands, except per share data) |
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Three Months Ended |
|
Twelve Months Ended |
|
|
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|
|
December 31, |
|
December 31, |
|
|
|
|
|
|
|
2016 |
|
|
|
2015 |
|
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|
2016 |
|
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|
2015 |
|
|
Consolidated Statement of Operations Data: |
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|
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Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration and license revenue |
|
|
|
$ |
4,684 |
|
|
$ |
- |
|
|
$ |
11,435 |
|
|
$ |
- |
|
|
Grant revenue |
|
|
|
|
205 |
|
|
|
- |
|
|
|
500 |
|
|
|
- |
|
|
Total revenue |
|
|
|
|
4,889 |
|
|
|
- |
|
|
|
11,935 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
|
|
9,249 |
|
|
|
8,230 |
|
|
|
37,945 |
|
|
|
33,183 |
|
|
General and administrative |
|
|
|
|
3,556 |
|
|
|
3,430 |
|
|
|
14,710 |
|
|
|
14,506 |
|
|
Total operating expenses |
|
|
|
|
12,805 |
|
|
|
11,660 |
|
|
|
52,655 |
|
|
|
47,689 |
|
|
Loss from
operations |
|
|
|
|
(7,916 |
) |
|
|
(11,660 |
) |
|
|
(40,720 |
) |
|
|
(47,689 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
|
|
|
251 |
|
|
|
86 |
|
|
|
757 |
|
|
|
384 |
|
|
Net loss |
|
|
|
|
$ |
(7,665 |
) |
|
$ |
(11,574 |
) |
|
$ |
(39,963 |
) |
|
$ |
(47,305 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted net loss per share |
|
|
|
$ |
(0.16 |
) |
|
$ |
(0.26 |
) |
|
$ |
(0.86 |
) |
|
$ |
(1.08 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used
to compute basic and diluted net loss per share |
|
|
|
|
47,900 |
|
|
|
44,145 |
|
|
|
46,432 |
|
|
|
43,890 |
|
|
|
|
|
|
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|
|
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|
December 31, |
|
|
|
|
|
|
|
|
|
|
|
2016 |
|
|
|
2015 |
|
|
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(in thousands) |
|
Consolidated Balance Sheet Data |
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|
|
|
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Cash, cash
equivalents and investments |
|
|
|
|
|
|
|
$ |
123,761 |
|
|
$ |
76,289 |
|
|
Accounts
receivable (1) |
|
|
|
|
|
|
|
|
30,205 |
|
|
|
- |
|
|
Working capital |
|
|
|
|
|
|
|
|
|
110,356 |
|
|
|
66,541 |
|
|
Total assets |
|
|
|
|
|
|
|
|
|
155,872 |
|
|
|
78,155 |
|
|
Accumulated
deficit |
|
|
|
|
|
|
|
|
(307,059 |
) |
|
|
(267,096 |
) |
|
Total
stockholders’ equity |
|
|
|
|
|
|
|
|
49,889 |
|
|
|
72,507 |
|
|
|
|
|
|
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(1)
Accounts receivable excludes the additional $20 million cash
commitment due from Vifor in December 2017 in connection with the
CCX140 |
agreement
as well as the $20 million cash commitment from Vifor in connection
with the February 2017 Avacopan territory expansion agreement. |
|
Contacts:
Susan M. Kanaya
Executive Vice President,
Chief Financial and Administrative Officer
investor@chemocentryx.com
Media:
Denise Powell
denise@redhousecomms.com
510.703.9491
Investors:
Steve Klass, Burns McClellan
212.213.0006
sklass@burnsmc.com
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