SEATTLE, March 7, 2018 /PRNewswire/ -- CTI BioPharma
Corp. (NASDAQ:CTIC) today reported financial results for the fourth
quarter and full year ended December 31,
2017.
Clinical / Regulatory
- In July 2017, the first patient
was enrolled in PAC203, a Phase 2 clinical trial of pacritinib in
patients with primary myelofibrosis who have failed prior
ruxolitinib therapy and/or have thrombocytopenia, to evaluate the
dose response relationship for safety and efficacy. The Company
expects to complete an interim analysis of data in the second
quarter of 2018, with full top-line data expected in the first
quarter of 2019.
- In January 2018, the Committee
for Medicinal Products for Human Use (CHMP) of the European
Medicines Agency (EMA) granted a three-month extension for
submitting responses to the Day 120 List of Questions (D120 LoQ)
for the MAA for pacritinib. As a result of the extension, the
Company anticipates submitting its response to the D120 LoQ
in May 2018 and receipt of the CHMP's opinion on the Marketing
Authorization Application (MAA) in the third quarter of 2018.
- In August 2017, enrollment was
completed in the PIX306 Phase 3 trial of PIXUVRI®
(pixantrone). Top-line results are event-driven and are expected in
the second quarter of 2018.
Financial and Partnerships
- In February 2018, received gross
proceeds of $69 million from an
underwritten public offering of common stock. In June 2017, the Company received gross proceeds of
$45 million through an underwritten
public offering of preferred stock.
- In January 2018, the Company
reincorporated in the State of
Delaware, triggering an automatic delisting of the Company's
common stock from the Borsa Italiana MTA exchange.
- In January 2018 and again in
June 2017, the Company announced that
it received a $10 million milestone payment
from Teva Pharmaceutical Industries Ltd. related to a
regulatory approval milestone for TRISENOX®.
- In April 2017, the Company announced the expansion of
the existing license and collaboration agreement with Servier,
providing Servier with rights to
PIXUVRI® (pixantrone) in all markets except in
the United States.
Board of Directors and Management
- In September 2017, Laurent Fischer, M.D. was appointed Chairman of
the Board of Directors. The Company also announced the
appointment of David Parkinson, M.D.
and Michael A. Metzger to the Board
of Directors in 2017. Phillip M.
Nudelman, Ph.D. and Jack W.
Singer, M.D. resigned as members of the Board.
- In March 2017, Adam Craig, M.D., Ph.D., was appointed
President and CEO and a Director of the Company, succeeding
Richard Love, who continues to serve
on the Company's Board. Additional management changes in 2017
included the promotion of David H. Kirske to Chief Financial
Officer and Bruce J. Seeley to Chief Operating
Officer.
"CTI BioPharma is now focused on the enrollment of patients
in the PAC203 study of our lead compound, pacritinib, for the
treatment of myelofibrosis. We are well-financed after recently
completing an over-subscribed public offering of our common stock,
and we believe we have sufficient cash to carry us through key
clinical and regulatory milestones over the next 24 months," said
Adam R. Craig, M.D., Ph.D.,
President and Chief Executive Officer of CTI BioPharma. "We look
forward to several key clinical and regulatory milestones in 2018,
including an interim data analysis for the PAC203 study of
pacritinib and top-line results in the PIX306 Phase 3 trial of
PIXUVRI® in the second quarter."
Fourth Quarter Financial Results
Total revenues for the fourth quarter and twelve months ended
December 31, 2017, were $0.46 million and $25.1
million, respectively, compared to $9.1 million and $57.4
million for the respective periods in 2016. The
decrease in total revenues for the twelve months of 2017 is
primarily due to recognition of $32
million in milestone revenue related to pacritinib in the
first quarter of 2016. Net product sales of PIXUVRI for the fourth
quarter and twelve months ended December 31,
2017, were zero and $0.9
million, respectively, compared to $1.0 million and $4.1
million for the respective periods in 2016. The decrease in
net product sales for the periods in 2017 compared to 2016, is
primarily related to the April 2017
expansion of the PIXUVRI agreement with Servier under which they
have rights in all markets except the
United States.
GAAP operating loss for the fourth quarter and twelve months
ended December 31, 2017, was
$13.7 million and $39.5 million, respectively, compared to GAAP
operating loss of $5.6 million and
$49.2 million for the respective
periods in 2016. Non-GAAP operating loss, which excludes non-cash
share-based compensation expense, for the fourth quarter and twelve
months ended December 31, 2017 was
$12.3 million and $33.8 million, respectively, compared to non-GAAP
operating loss of $3.5million and
$35.8 million for the respective
periods in 2016. Non-cash share-based compensation expense for the
fourth quarter and twelve months ended December 31, 2017, was $1.4 million and
$5.7 million, respectively, compared
to $2.1 million and $13.3
million for the respective periods in 2016. The decrease in
operating loss for the fourth quarter and twelve months of 2017 was
due to a significant decrease in research and development and
selling, general and administrative expenses primarily related to a
decrease in pacritinib development costs as a result of the
completion of the Phase 3 clinical studies in 2017 and a decrease
in expenses for the manufacture of pacritinib and personnel costs.
For information on CTI BioPharma's use of non-GAAP operating loss
and a reconciliation of such measure to GAAP operating loss, see
the section below entitled "Non-GAAP Financial Measures."
Net loss for the fourth quarter of 2017 was $14.3 million, or ($0.33) per share, compared to a net loss of
$6.4 million, or ($0.23) per share, for the same period in 2016.
Net loss for the twelve months ended December 31, 2017, was $45.0 million, or ($1.24) per share, compared to a net loss of
$52.0 million, or ($1.86) per share, for the same period in
2016.
As of December 31, 2017, cash,
cash equivalents and restricted cash totaled $43.2 million, compared to $44.0 million at December
31, 2016.
Conference Call Information
CTI BioPharma management will host a conference call to
review its fourth quarter and full year 2017 financial results and
provide an update on business activities. The event will be held
today at 1:30 p.m. PT / 4:30 p.m. ET / 10:30
p.m. CET. Participants can access the call at 1-800-289-0517
(domestic) or + +1 323-994-2084 (international). To access the live
audio webcast or the subsequent archived recording,
visit www.ctibiopharma.com. Webcast and telephone replays of
the conference call will be available approximately two hours after
completion of the call. Callers can access the replay by dialing
1-888-203-1112 (domestic) or +1 719-457-0820
(international). The access code for the replay is 2516357. The
telephone replay will be available until March 14, 2018.
About CTI BioPharma Corp.
CTI BioPharma Corp. is a biopharmaceutical company focused on
the acquisition, development and commercialization of novel
targeted therapies covering a spectrum of blood-related cancers
that offer a unique benefit to patients and healthcare providers.
CTI BioPharma has a late-stage development pipeline, including
pacritinib for the treatment of patients with myelofibrosis. CTI
BioPharma is headquartered in Seattle,
Washington.
Non-GAAP Financial Measures
CTI BioPharma has provided in this press release the historical
non-GAAP financial measure of operating loss, excluding non-cash
share-based compensation expense, for the fourth quarter and twelve
months ended December 31, 2017 and
December 31, 2016. Due to varying
available valuation methodologies, subjective assumptions and the
different GAAP accounting treatment of different award types that
companies can use under ASC Topic 718, CTI BioPharma's management
believes that providing a non-GAAP financial measure that excludes
non-cash share-based compensation expense can enhance management's
and investors' comparison of CTI BioPharma's operating results over
different periods of time as compared to the operating results of
other companies.
CTI BioPharma's use of a non-GAAP financial measure has
limitations and should not be considered in isolation from, or as a
substitute for, financial information prepared in accordance with
GAAP. One limitation is that CTI BioPharma's reported non-GAAP
operating loss in 2017 results in the exclusion of a recurring
expense, since CTI BioPharma expects that share-based compensation
will continue to be a significant recurring expense in CTI
BioPharma's business. A second limitation is that CTI BioPharma's
methodology for calculating non-GAAP operating loss, which only
excludes the component of share-based compensation, may differ from
the methodology CTI BioPharma's peer companies utilize to the
extent they report non-GAAP operating income or similarly titled
measures. Accordingly, CTI BioPharma's non-GAAP operating loss may
not necessarily be comparable to similarly titled measures of other
companies. Investors are urged to review the reconciliation of
these non-GAAP measures to their most directly comparable GAAP
financial measures. A reconciliation of CTI BioPharma's non-GAAP
financial measures to the most directly comparable GAAP measures
has been provided in the financial statement tables included below
in this press release.
Forward-Looking Statements
This press release includes forward-looking statements within
the meaning of the Safe Harbor provisions of the Private Securities
Litigation Reform Act of 1995. Such statements are subject to
a number of risks and uncertainties, the outcome of which could
materially and/or adversely affect actual future results and the
trading price of CTI BioPharma's securities. Such statements
include, but are not limited to, expectations with respect to
the timing and planned enrollment of PAC203 and our ability to
interpret clinical trial data and results for PERSIST-2 despite not
satisfying the pre-specified minimum evaluable patient goal,
expectations with respect to the potential therapeutic utility of
pacritinib, expectations with respect to the timing of data and the
related analyses, expectations with respect to the timing of
regulatory actions,expectations with respect to the potential of
pacritinib to achieve treatment goals, the development of CTI
BioPharma and its product and product candidate portfolio,
including the advancement of pacritinib and other pipeline
programs, CTI BioPharma's ability to achieve its goals in 2018 and
beyond, CTI BioPharma's intent to continue efforts to commercialize
PIXUVRI in Europe and expand the
market potential for PIXUVRI, and CTI BioPharma's plans to continue
advancing the development of its pipeline candidates through
strategic product collaborations or cooperative group and
investigator-sponsored trials, as well as the identification and
acquisition of additional pipeline opportunities. Risks that
contribute to the uncertain nature of the forward-looking
statements include, among others, risks associated with the
biopharmaceutical industry in general and with CTI BioPharma and
its product and product candidate portfolio in particular
including, among others, risks associated with the following: that
CTI BioPharma cannot predict or guarantee the outcome of
preclinical and clinical studies, the potential failure of
pacritinib to prove safe and effective as determined by the FDA
and/or the European Medicines Agency, changes to study protocol or
design or sample size to address any patient safety, efficacy or
other issues raised by the FDA or otherwise, that top-line results
observed to date may differ from future results or that different
conclusions or considerations may qualify such results once
existing data has been more fully evaluated, that CTI BioPharma may
not obtain favorable determinations by other regulatory, patent and
administrative governmental authorities, that CTI BioPharma may
experience delays in the commencement of preclinical and clinical
studies, that the costs of developing pacritinib and CTI
BioPharma's other product candidates may rise; other risks,
including, without limitation, competitive factors, technological
developments, that CTI BioPharma may not be able to sustain its
current cost controls or further reduce its operating expenses,
that CTI BioPharma may not achieve previously announced goals,
contractual milestones and objectives as or when projected, that
CTI BioPharma's average net operating burn rate may increase, that
CTI BioPharma will continue to need to raise capital to fund its
operating expenses, but may not be able to raise sufficient amounts
to fund its continued operation; as well as other risks listed or
described from time to time in CTI BioPharma's most recent filings
with the SEC on Forms 10-K, 10-Q and 8-K. Except as required by
law, CTI BioPharma does not intend to update any of the statements
in this press release upon further developments.
CTI BioPharma Investor Contacts:
Tricia Truehart
+1 646 378 2953
ttruehart@troutgroup.com
CTI BioPharma
Corp.
Condensed
Consolidated Statements of Operations
(In thousands, except
per share amounts)
(unaudited)
|
|
|
Three Months
Ended
December
31,
|
|
Twelve Months
Ended
December
31,
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
Revenues:
|
|
|
|
|
|
|
|
Product sales,
net
|
$
|
—
|
|
|
$
|
1,015
|
|
|
$
|
853
|
|
|
$
|
4,127
|
|
License and contract
revenue
|
462
|
|
|
8,121
|
|
|
24,293
|
|
|
53,278
|
|
Total
revenues
|
462
|
|
|
9,136
|
|
|
25,146
|
|
|
57,405
|
|
Operating costs and
expenses:
|
|
|
|
|
|
|
|
Cost of product
sold
|
84
|
|
|
864
|
|
|
364
|
|
|
1,377
|
|
Research and
development
|
7,098
|
|
|
9,702
|
|
|
32,866
|
|
|
64,961
|
|
Selling, general and
administrative
|
6,983
|
|
|
9,205
|
|
|
31,435
|
|
|
45,306
|
|
Other operating
income
|
—
|
|
|
(5,077)
|
|
|
—
|
|
|
(5,077)
|
|
Total operating costs
and expenses, net
|
14,165
|
|
|
14,694
|
|
|
64,665
|
|
|
106,567
|
|
Loss from
operations
|
(13,703)
|
|
|
(5,558)
|
|
|
(39,519)
|
|
|
(49,162)
|
|
Non-operating income
(expense):
|
|
|
|
|
|
|
|
Interest
expense
|
(393)
|
|
|
(589)
|
|
|
(1,872)
|
|
|
(2,614)
|
|
Amortization of debt
discount and issuance costs
|
(50)
|
|
|
(37)
|
|
|
(163)
|
|
|
(214)
|
|
Foreign exchange gain
(loss)
|
42
|
|
|
(377)
|
|
|
817
|
|
|
(484)
|
|
Other non-operating
expense
|
(166)
|
|
|
—
|
|
|
(94)
|
|
|
(479)
|
|
Net loss before
noncontrolling interest
|
(14,270)
|
|
|
(6,561)
|
|
|
(40,831)
|
|
|
(52,953)
|
|
Noncontrolling
interest
|
4
|
|
|
189
|
|
|
161
|
|
|
944
|
|
Net loss
|
(14,266)
|
|
|
(6,372)
|
|
|
(40,670)
|
|
|
(52,009)
|
|
Deemed
dividends on preferred stock
|
—
|
|
|
—
|
|
|
(4,350)
|
|
|
—
|
|
Net loss attributable
to common shareholders
|
$
|
(14,266)
|
|
|
$
|
(6,372)
|
|
|
$
|
(45,020)
|
|
|
$
|
(52,009)
|
|
Basic and diluted net
loss per common share
|
$
|
(0.33)
|
|
|
$
|
(0.23)
|
|
|
$
|
(1.24)
|
|
|
$
|
(1.86)
|
|
Shares used in
calculation of basic and diluted net loss per common
share
|
42,899
|
|
|
28,035
|
|
|
36,445
|
|
|
27,948
|
|
Balance Sheet Data
(unaudited):
|
|
(amounts in
thousands)
|
|
|
December
31,
|
|
December
31,
|
|
|
2017
|
|
2016
|
Cash, cash
equivalents and restricted cash
|
|
$
|
43,218
|
|
|
$
|
44,002
|
|
Working
capital
|
|
27,666
|
|
|
15,178
|
|
Total
assets
|
|
54,886
|
|
|
63,843
|
|
Current portion of
long-term debt
|
|
444
|
|
|
7,949
|
|
Long-term debt, less
current portion
|
|
13,575
|
|
|
11,311
|
|
Total shareholders'
equity
|
|
16,090
|
|
|
7,757
|
|
Non-GAAP
Reconciliations
(In thousands)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
December 31,
|
|
Twelve Months Ended
December 31,
|
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
|
As reported - loss
from operations (GAAP)
|
$
|
(13,703)
|
|
|
$
|
(5,558)
|
|
|
(39,519)
|
|
|
$
|
(49,162)
|
|
|
As reported -
share-based compensation expense (GAAP)
|
1,443
|
|
|
2,099
|
|
|
5,746
|
|
|
13,324
|
|
|
As adjusted - loss
from operations (Non-GAAP)
|
$
|
(12,260)
|
|
|
$
|
(3,459)
|
|
|
$
|
(33,773)
|
|
|
$
|
(35,838)
|
|
|
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SOURCE CTI BioPharma Corp.