Cell Therapeutics Reports First Quarter 2014 Financial Results
- Reports Net Product Sales Growth for PIXUVRI® Following Positive
Reimbursement Decisions in Key E.U. Countries -
- Conference Call Scheduled for Today at 4:30 p.m. Eastern Time -
SEATTLE, April 29, 2014
SEATTLE, April 29, 2014 /PRNewswire/ -- Cell Therapeutics, Inc. (CTI) (NASDAQ
and MTA: CTIC) today reported financial results for the first quarter ended
March 31, 2014.
"In the first quarter, we achieved growth in E.U. sales of PIXUVRI for the
treatment of patients with aggressive B-cell non-Hodgkin lymphoma, which is
due in part to the previously announced favorable reimbursement decisions,
demonstration of cost effectiveness and growing awareness among key opinion
leaders in the lymphoma community," said James A. Bianco, M.D., President and
CEO. "We believe we are on track to achieve our stated corporate goal of
operating the commercial business with a net positive product contribution by
year-end. Another of our corporate goals this year is to expand the global
reach and revenue potential of PIXUVRI through a potential partnership in the
rest of world, excluding countries in the E.U. where CTI has a commercial
presence and the U.S. In addition to driving PIXUVRI sales, we are focused on
completing the first Phase 3 clinical trial of pacritinib, an oral JAK2/FLT3
inhibitor, in myelofibrosis and reporting the topline results late this year,
while advancing the second pacritinib Phase 3 trial."
First Quarter 2014 Financial Results
For the quarter ended March 31, 2014, CTI reported revenue of $1.4 million,
compared to revenue of $1.1 million for the same period in 2013. The revenues
in the first quarter 2014 were primarily attributable to net product sales of
PIXUVRI. CTI sells PIXUVRI directly to health care providers through a product
dedicated contract sales force and through a limited number of wholesale
distributors in the E.U.
The non-GAAP operating loss, which excludes non-cash share-based compensation
expense, for the first quarter of 2014 was $19.8 million, compared to $16.1
million for the same period in 2013. The GAAP operating loss was $27.7 for the
first quarter of 2014, compared to $18.5 million for the same period in 2013.
The increase in GAAP operating loss primarily related to the ongoing PERSIST-1
and PERSIST-2 Phase 3 clinical trials of pacritinib and included $7.8 million
non-cash share-based compensation expense for the first quarter of 2014,
compared to $2.4 million for the same period in 2013. For information on CTI's
use of the aforementioned non-GAAP measure and a reconciliation of such
measure to GAAP operating loss, see the section below entitled "Non-GAAP
The net loss for the first quarter of 2014 was $29.0 million (which included a
$7.8 million non-cash share-based compensation expense), or ($0.20) per share,
compared to $19.4 million (which included a $2.4 million non-cash share-based
compensation expense), or ($0.18) per share, for the same period in 2013.
As of March 31, 2014, CTI's cash and cash equivalents totaled $50.6 million.
Assuming that patient enrollment continues at the rate at which we have
experienced in recent months, CTI believes it would be on track to earn a $20
million milestone in mid-year 2014 related to the PERSIST-1 trial under our
agreement with Baxter International, Inc., or Baxter.
Financial Guidance for 2014
CTI reaffirms prior financial guidance that non-GAAP operating loss for 2014
is expected to approximate $45 to $50 million, which excludes non-cash
share-based compensation expense. For the elements comprising this financial
guidance, please refer to our press release issued on March 4, 2014.
Actual financial results for 2014 will vary based upon many factors, including
the degree of market acceptance and reimbursement rates for PIXUVRI in Europe,
the rate of patient enrollment in ongoing clinical trials, the attainment and
timing of milestone payments projected to be earned and received under CTI's
collaboration with Baxter and other factors described in our filings with the
Securities and Exchange Commission.
Select First Quarter 2014 and Recent Highlights
PIXUVRI^® (pixantrone) Commercial:
oReported that the U.K.'s National Institute for Health and Care Excellence
issued final guidance recommending prescription of PIXUVRI as a
cost-effective monotherapy for the treatment of adult patients with
multiply relapsed or refractory aggressive B-cell non-Hodgkin lymphoma.
oAnnounced the launch of PIXUVRI in the U.K.
Research and Development:
oInitiated PERSIST-2, the second Phase 3 clinical trial evaluating
pacritinib in patients with myelofibrosis who have low platelet counts.
This trial, together with PERSIST-1, is intended to support registration
in the U.S. and Europe.
oAnnounced the Gynecologic Oncology Group informed CTI that it had
completed enrollment in the GOG-0212 Phase 3 clinical trial of
investigational agent paclitaxel poliglumex (Opaxio™) as maintenance
therapy in ovarian cancer.
oReached an agreement with Novartis to regain rights to PIXUVRI and Opaxio,
providing CTI with the flexibility to manage these assets within the
context of its overall product portfolio strategy.
Conference Call Information
CTI management will host a conference call to review its first quarter 2014
financial results and provide an update on business activities. The event will
be held today at1:30 p.m.PDT / 4:30 p.m.EDT / 10:30 p.m. CEST. Participants
can access the call at 1-877-941-6009 (domestic) or +1 480-629-9819
(international). To access the live audio webcast or the subsequent archived
recording, visit CTI's website, www.celltherapeutics.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
1-800-406-7325 (domestic) or +1 303-590-3030 (international). The access code
for the replay is 4678242. The telephone replay will be available
untilTuesday, May 6, 2014.
About Cell Therapeutics, Inc.
CTI (NASDAQ and MTA: CTIC) is a biopharmaceutical company focused on the
acquisition, development and commercialization of an integrated portfolio of
oncology products aimed at making cancer more treatable. CTI is headquartered
in Seattle, WA. For additional information and to sign up for email alerts and
get RSS feeds, please visit www.CellTherapeutics.com.
Non-GAAP Financial Measures
CTI has provided in this press release the historical financial measure of
loss from operations, excluding non-cash share-based compensation expense,
which is a non-GAAP measure, for the first quarter ended March 31, 2014, and
the financial projection of loss from operations, excluding non-cash
share-based compensation expense, which is a non-GAAP measure, for the 2014
fiscal year. 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's management believes
that providing a non-GAAP financial measure that excludes non-cash share-based
compensation can enhance management's and investors' comparison of CTI's
operating results over different periods of time as compared to the operating
results of other companies.
Our 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 our reported non-GAAP
loss from operations results in the exclusion of a recurring expense, since
share-based compensation will continue to be a significant recurring expense
in CTI's business. A second limitation is that our methodology for calculating
non-GAAP loss from operations, which only excludes the component of
share-based compensation, may differ from the methodology our peer companies
utilize to the extent they report non-GAAP loss from operations or similarly
titled measures and accordingly 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's non-GAAP financial measures
to their most directly comparable GAAP measures has been provided in the
financial statement tables included below in this press release.
CTI has not included a reconciliation of our projected non-GAAP loss from
operations to a projected GAAP loss from operations because the calculation of
the excluded share-based compensation would require information that is
presently uncertain, such as the future level of additional equity awards that
will be granted to meet CTI's compensation philosophy and objectives after
taking into account the economic climate at the time of grant. In addition,
the calculation is largely based on the price of CTI's stock at the time of
the specific grants (as required under ASC Topic 718), which price is variable
and therefore unknowable until the grant is made. Because of the contingent
nature of such factors, CTI believes that the specific adjustment for future
share-based compensation cannot be forecast with accuracy.
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's securities.Such statements include,
but are not limited to, statements regarding CTI's expectations with respect
to the development of CTI and its product and product candidate portfolio,
CTI's ability to meet its 2014 corporate goals (including that of operating
the commercial business with a net product contribution by year-end,
consummating a partnership for PIXUVRI, completing PERSIST-1 and reporting the
topline results late this year and advancing PERSIST-2), the rate at which we
expect PERSIST-1 to enroll, potential attainment of the $20 million milestone
in mid-year 2014 under our agreement with Baxter, CTI's projected non-GAAP
operating loss, the potential registration of pacritinib in the U.S. and
Europe, the benefits of the reacquisition of rights to PIXUVRI and Opaxio and
liquidity and expense projections.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 and its
product and product candidate portfolio in particular including, among others,
risks associated with the following: that CTI cannot predict or guarantee the
pace or geography of enrollment of its clinical trials, that CTI cannot
predict or guarantee the outcome of preclinical and clinical studies, that CTI
may not obtain reimbursement for PIXUVRI in certain markets in Europe as
planned or at all, that the conditional marketing authorization for PIXUVRI
may not be renewed or may be subject to additional conditions, that CTI may
not obtain favorable determinations by other regulatory, patent and
administrative governmental authorities, that CTI may experience delays in the
commencement of preclinical and clinical studies, risks related to the costs
of developing, producing and selling PIXUVRI, pacritinib and CTI's other
product candidates, and other risks, including, without limitation,
competitive factors, technological developments, that CTI's operating expenses
continue to exceed its net revenues, that CTI may not be able to sustain its
current cost controls or further reduce its operating expenses, that CTI may
not achieve previously announced goals and objectives as or when projected,
that CTI's average net operating burn rate may increase, and that CTI 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's most recent filings
with theSecurities and Exchange Commission on Forms10-K, 10-Q and 8-K.
Except as required by law, CTI does not intend to update any of the statements
in this press release upon further developments.
PIXUVRI is a registered trademark ofCell Therapeutics, Inc.
CTI Life Sciences Limited, Milan Branch
+39 02 0061-6550
Cell Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except for per share amounts)
Three Months Ended
Product sales, net $ 1,268 $
License and contract revenue 143 -
Total revenues 1,411 1,126
Operating costs and expenses:
Cost of product sold 145 55
Research and development 12,179 8,355
Selling, general and administrative 16,750 11,143
Settlement expense - 95
Total operating costs and 29,074 19,648
Loss from operations (27,663) (18,522)
Other income (expense):
Interest expense (464) (48)
Amortization of debt discount and issuance (178) (23)
Foreign exchange loss (5) (751)
Other expense (886) (272)
Net loss before noncontrolling interest (29,196) (19,616)
Noncontrolling interest 194 232
Net loss $ (29,002) $ (19,384)
Basic and diluted net loss per common share $ (0.20) $
Shares used in calculation of basic and
diluted net loss per common share
Balance Sheet Data (unaudited): (amounts in thousands)
March 31, December 31,
Cash and cash equivalents $ 50,601 $ 71,639
Working capital 41,815 60,446
Total assets 73,286 93,723
Current portion of long-term debt 2,527 3,155
Long-term debt, less current portion 10,861 10,152
Total shareholders' equity 23,225 42,758
Three Months Ended
As reported - loss from operations (GAAP) $ (27,663) $ (18,522)
As reported - share-based compensation expense (GAAP) 7,829 2,428
As adjusted - loss from operations (Non-GAAP) $ (19,834) $ (16,094)
SOURCE Cell Therapeutics, Inc.
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