Cell Therapeutics Reports Fourth Quarter and Full Year 2012 Financial Results
- Conference call scheduled today at 4:30 p.m. Eastern time -
SEATTLE, Feb. 28, 2013
SEATTLE, Feb. 28, 2013 /PRNewswire/ -- Cell Therapeutics, Inc.(CTI) (NASDAQ
and MTA: CTIC) today reported financial results for the fourth quarter and
full year ended December 31, 2012.
"During the fourth quarter 2012, we began making PIXUVRI available to
healthcare providers in the European Union and initiated commercial operations
on a country-by-country basis," said James Bianco, M.D., President and CEO of
CTI. "PIXUVRI is now available in eight countries in the E.U., and we are
engaged in activities to increase awareness in the physician community of
PIXUVRI's benefits for patients with multiply relapsed or refractory
aggressive non-Hodgkin lymphoma. Separately, we have recently begun enrollment
in the Phase 3 PERSIST-1 clinical trial of pacritinib for the treatment of
patients with myelofibrosis. We believe that pacritinib, an oral, once-daily
JAK2/FLT3 inhibitor, may offer patients an effective therapy with a safety
profile that could allow for longer-term management of their disease. For
2013, we are focused on increasing use and adoption of PIXUVRI, while
obtaining favorable reimbursement in major markets in the E.U.; building value
through development of our late-stage product pipeline, with emphasis on
pacritinib; and securing non-equity based operating capital through strategic
partnerships, while managing our expenses."
2012 and Recent Key Highlights
European Union (E.U.) Commercial
oObtained conditional marketing authorization for PIXUVRI® (pixantrone)
from the European Commission (EC) in May 2012 as the first medicinal
product for the treatment of adult patients with multiply relapsed or
refractory aggressive non-Hodgkin B-cell lymphomas (NHL). This approval
was based on the results from our pivotal Phase 3 clinical trial known as
EXTEND or PIX301. The benefit of PIXUVRI treatment has not been
established in patients when used as fifth line or greater chemotherapy in
patients who are refractory to last therapy.
oBegan to establish a cost-effective European commercial operation and
initiated PIXUVRI commercial availability in eight countries: Austria,
Denmark, Finland, France, Netherlands, Norway, Sweden and the United
Kingdom. During the fourth quarter 2012, CTI was building and training a
commercial network of skilled and experienced sales people in order to be
ready for PIXUVRI commercial launch in January 2013.
oAnnounced the publication of PIXUVRI pivotal Phase 3 study results in
Research and Development
oAcquired pacrinitib from S*BIO Pte Ltd.in May 2012. Pacritinib is an
oral, once-daily JAK2/FLT3 inhibitor that demonstrated meaningful clinical
benefits and good tolerability in myelofibrosis patients in Phase 2
clinical trials, without treatment-emergent drug-related thrombocytopenia
oIn January 2013, initiated patient enrollment in PERSIST-1, which is the
first of two planned investigational Phase 3 studies of pacritinib in
patients with myelofibrosis. PERSIST-1 is a randomized trial that is
expected to enroll 270 patients in Europe, Australia and the U.S. and is
designed to evaluate the safety and efficacy of pacritinib compared to
best available therapy, excluding JAK inhibitors, in patients with
myelofibrosis. A second Phase 3 trial is planned to initiate in the second
half of 2013.
oInitiated Phase 2 investigator-sponsored trials of tosedostat in
combination with standard agents in the treatment of patients with acute
myeloid leukemia and myelodysplastic syndrome.
oReceived U.S. orphan drug status for Opaxio™ for malignant brain cancer.
oStrengthened the Company's balance sheet through an underwritten public
offering, resulting in gross proceeds of $60 million.
oAdded to the senior executive team:
oSteven E. Benner, M.D., M.H.S. joined as EVP and Chief Medical
Officer, former CMO of OncoMed and Protein Design Labs and previously
held senior executive roles at Bristol-Myers Squibb in global
development and life cycle management.
oMatthew J. Plunkett, Ph.D., joined as Executive Vice President,
Corporate Development, former Managing Director and Head of West
Coast Biotechnology for Oppenheimer & Co. and its U.S. predecessor,
CIBC World Markets.
Fourth Quarter and Full Year 2012 Financial Results
Total net operating expenses for 2012 were $101.5 million, which includes
$29.1 millionfor acquired in-process research and development expense related
to the acquisition of pacritinib from S*BIO Pte Ltd.in 2012. As of December
31, 2012, CTI's cash and cash equivalents totaled $50.4 million.
For the year ended December 31, 2012, CTI reported a net loss of $115.3
million, or ($1.98) per share, compared to a net loss of $121.1 million, or
($3.53) per share, for the year ended December 31, 2011. The decrease in net
loss for the year ended December 31, 2012 was primarily due to a decrease in
non-cash deemed dividends on preferred stock issuances. Net loss for the
fourth quarter ended December 31, 2012 was $19.0 million or ($0.20) per share,
compared to a net loss of $17.9 million, or ($0.47) per share, for the same
period in 2011.
Financial Guidance for 2013
For 2013, loss from operations is expected to be approximately $60 to $65
million, excluding non-cash stock-based compensation expense. The projected
decrease in 2013 loss from operations, compared to 2012, primarily relates to
expected changes in:
oContribution margin from PIXUVRI commercial operations, as we intend to
operate the commercial business with a net positive contribution;
oSG&A expenses, including sales and marketing expenses to drive sales of
PIXUVRI, as well as medical affairs expenses in support of educational
programs for the hematologist/oncologist community in the E.U.; and
oR&D expenses, including management of costs for ongoing and planned
clinical trials involving pacritinib, including post-approval study of
PIXUVRI required by the European Commission.
Actual financial results for 2013 will vary based upon many factors, including
the growth of PIXUVRI sales and determination of reimbursement rates for
PIXUVRI, and the rate of patient enrollment in pacritinib clinical trials that
are ongoing and planned for initiation in 2013.
Target Milestones for 2013
oDrive use and adoption of PIXUVRI in relapsed or refractory aggressive
B-cell NHL in the E.U. with a positive contribution margin.
oSecure reimbursement for PIXUVRI in Germany, United Kingdom, France and
Italy in the second half of 2013.
oInitiate second Phase 3 trial (PERSIST-2) of pacritinib for the treatment
of patients with myelofibrosis who have platelet counts of less than
100,000/µL in second half of 2013.
oComplete patient accrual in PERSIST-1 Phase 3 trial of pacritinib for the
treatment of patients with myelofibrosis in 2013 or early 2014.
oSecure non-equity based capital through an ex-U.S. partnership for
oReport results from investigator-sponsored trials for tosedostat and
Opaxio at scientific meetings.
Conference Call Information
CTI management will host a conference call to review its fourth quarter and
full year 2012 financial results and provide an update on business activities.
The event will be held today at1:30 p.m.PST / 4:30 p.m.EST/ 10:30 p.m. CET.
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 at 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 4603217#. The webcast will be recorded and
available for replay on CTI's website until April 30, 2013.
About Cell Therapeutics, Inc.
Cell Therapeutics (NASDAQ and MTA: CTIC) is a biopharmaceutical company
committed to the 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 the company's website at
This press release contains forward-looking statements that involve a number
of risks and uncertainties, the outcome of which could materially and/or
adversely affect actual future results and the market price of CTI's
securities. The risks and uncertainties that could affect the development of
PIXUVRI, pacritinib, tosedostat or Opaxio include risks associated with
preclinical and clinical developments in the biopharmaceutical industry in
general and with PIXUVRI, pacritinib, tosedostat or Opaxio in particular
including, without limitation, the potential failure of PIXUVRI to prove safe
and effective for the treatment of relapsed or refractorynon-Hodgkin lymphoma
(NHL) and/or other tumors as determined by theU.S. Food and Drug
Administration; that CTI's plan to make PIXUVRI commercially available in
additional countries inEurope may not occur as planned and that CTI's sales
of PIXUVRI may not occur as planned; that CTI may not secure reimbursement for
PIXUVRI in Germany, United Kingdom, France and Italy in the second half of
2013; that CTI may not be able to complete the PIX306 clinical trial of
PIXUVRI-rituximab compared to gemcitabine-rituximab in patients who have
relapsed after 1 to 3 prior regimens for aggressive B‑cellNHL and who are
not eligible for autologous stem cell transplant byJune 2015or at all as
required by the European Medicines Agency; that CTI may not have the results
of the PIX306 clinical trial available byJune 2015or at all; that CTI may
not be able complete a post-marketing study aimed at confirming the clinical
benefit observed in the PIX301 trial; that the conditional marketing
authorization for PIXUVRI may not be renewed; that CTI may not complete
patient accrual in the PERSIST-1 Phase 3 trial of pacritinib for the treatment
of patients with myelofibrosis in 2013 or early 2014; the potential that the
second Phase 3 study of pacritinib might not begin in the second half of 2013;
that pacritinib may not prove safe and effective for primary MF and MF
secondary to other myeloproliferative neoplasms; that CTI may not secure
non-equity based capital through an ex-U.S. partnership for pacritinib in 2013
or at all; the potential that phase 3 studies of tosedostat may not occur as
planned; the potential failure of tosedostat to prove safe and effective for
the treatment of elderly patients with newly-diagnosed acute myeloid leukemia
or high-risk myelodysplastic syndrome (including when administered in
combination with cytarabine or decitabine) as determined by theFDAand/or the
EMA; the potential failure of combination studies of tosedostat with
hypomethylating agents in treating AML and/or MDS; that the studies of
tosedostat may not achieve their primary and/or secondary objectives; that
tosedostat may not be approved by the FDAand/or the EMA; that CTI cannot
guarantee or predict whether or not orphan-drug designation of Opaxio for
glioblastoma multiforme will provide a substantial benefit to CTI; that CTI
cannot predict or guarantee the pace or geography of enrollment of its
clinical trials or the total number of patients enrolled; that CTI's average
net operating burn rate may increase; CTI's ability to continue to raise
capital as needed to fund its operations in general; and risks related to
competitive factors, technological developments, costs of developing,
producing, and selling PIXUVRI, including, without limitation, the risk
factors listed or described from time to time in CTI's filings with
theSecurities and Exchange Commissionincluding, without limitation, CTI's
most recent filings on Forms 10-K, 10-Q and 8-K. Except as may be required by
law, CTI does not intend to update or alter its forward-looking statements
whether as a result of new information, future events, or otherwise.
Cell Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(In thousands, except for per share amounts)
Three Months Ended Year Ended
December 31, December 31,
2012 2011 2012 2011
Operating expenses, net:
Research and $ 9,121 $ $ 33,201 $ 34,900
Selling, general and 9,220 12,993 38,244 38,290
research and - - 29,108 -
Settlement expense 509 (11,000) 944 (11,000)
Total operating 18,850 9,911 101,497 62,190
Loss from operations (18,850) (9,911) (101,497) (62,190)
Other income (expense):
Investment and other (299) 1,612 (478) 1,545
income (expense), net
Interest expense (5) (136) (56) (870)
Amortization of debt
discount and issuance - (110) - (546)
Foreign exchange gain 440 (502) 344 (558)
Net loss before (18,714) (9,047) (101,687) (62,619)
Noncontrolling interest 113 80 313 259
Net loss attributable to (18,601) (8,967) (101,374) (62,360)
Dividends and deemed
dividends on preferred (429) (8,901) (13,901) (58,718)
Net loss attributable to $ (19,030) $ (17,868) $ (115,275) $ (121,078)
CTI common shareholders
Basic and diluted net $ $ $ $
loss per common share (0.20) (0.47) (1.98) (3.53)
Shares used in
calculation of basic and
net loss per common 95,896 37,703 58,125 34,294
Balance Sheet Data (amounts in thousands)
Cash and cash $ 50,436 $ 47,052
Working capital 37,644 33,291
Total assets 73,713 62,239
Total shareholders' 32,944 28,009
SOURCE Cell Therapeutics, Inc.
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