Management to Host Conference Call/Webcast Today at 4:30 p.m. Eastern Time
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SEATTLE, Aug. 2, 2018 /PRNewswire/ -- CTI Biopharma Corp. (NASDAQ:CTIC) today reported financial results for the second quarter and six months ended June 30, 2018. In July 2018, CTI BioPharma announced the continuation without modification of the PAC203 Phase 2 study following a planned interim review by an Independent Data Monitoring Committee. The Company also announced a pacritinib program update following a Type B meeting with the U.S. Food and Drug Administration (FDA) and announced a plan to conduct a new, randomized, Phase 3 study of pacritinib in patients with myelofibrosis. The Company has recently received the Day 180 List of Outstanding Issues from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) regarding the marketing authorization application (MAA) for pacritinib. Following the recently reported results from the PIX306 study, the Company is conducting a review of the clinical study data to assess the next steps for the PIXUVRI® program. Upcoming Milestones
"We believe we have now re-established a collaborative relationship with the FDA and have received greater clarity on the development path for pacritinib in the U.S.," commented Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI BioPharma. "We plan to request a meeting with the FDA following the second interim analysis of PAC203 data with a meeting expected in the fourth quarter of 2018. The purpose of the meeting will be to discuss the interim data and to review the design of a registrational Phase 3 trial. We expect that this trial will begin in 2019, once the optimal dose of pacritinib has been confirmed using all pharmacokinetic, efficacy and safety data from the PAC203 study." "In Europe, we continue to make progress with our marketing authorization application (MAA) and have now received the Day 180 List of Outstanding Issues report. The EMA has expressed interest in the emerging data from the PAC203 study, so the two month extension granted by CHMP will allow us to submit additional PAC203 data for review as part of our Day 180 responses." Second Quarter Financial Results Total revenues for the second quarter and six months ended June 30, 2018 were $0.6 million and $11.1 million, respectively, compared to $22.2 million and $23.0 million for the respective periods in 2017. The decrease in total revenues for the second quarter in 2018 compared to the same period in 2017 is primarily due to license and contract revenue that included the recognition of payments received from the expansion of the license and collaboration agreement for PIXUVRI® with Servier in 2017 as well as the receipt of a payment from Teva Pharmaceutical Industries Ltd. related to the achievement of a sales milestone for TRISENOX® (arsenic trioxide) in 2017. The decrease in total revenues for the six months ended June 30, 2018, compared to the same period in 2017 is primarily due to license and contract revenue that included the recognition of payments received from the expansion of the license and collaboration agreement for PIXUVRI® with Servier in 2017. GAAP operating loss was $14.0 million and $18.3 million for the second quarter and six months ended June 30, 2018, respectively, compared to GAAP operating income of $5.3 million and GAAP operating loss of $14.0 million for the respective periods in 2017. Non-GAAP operating loss, which excludes non-cash share-based compensation expense, for the second quarter and six months ended June 30, 2018 was $13.0 million and $16.0 million, respectively, compared to non-GAAP operating income of $6.4 million and non-GAAP operating loss of $11.1 million for the respective periods in 2017. Non-cash share-based compensation expense for the second quarter and six months ended June 30, 2018, was $1.0 million and $2.4 million, respectively, compared to $1.1 million and $2.9 million for the respective periods in 2017. Operating loss in the second quarter of 2018 as compared to an operating income for the same period in 2017 resulted primarily from the decrease in license and contract revenue as mentioned above and a decrease in selling, general and administrative expenses. Operating loss for the six months ended June 30, 2018, compared to the same period in 2017 resulted primarily from the decrease in license and contract revenue as mentioned above and a decrease in selling, general and administrative expenses. 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 titled "Non-GAAP Financial Measures." Net loss for the second quarter of 2018 was $11.3 million, or $(0.20) per share, compared to a net income of $1.0 million, or $0.03 per share, for the same period in 2017. Net loss for six months ended June 30, 2018, was $15.4 million, or $(0.29) per share, compared to a net loss of $18.8 million, or ($0.63) per share, for the same period in 2017. As of June 30, 2018, cash, cash equivalents and short-term investments totaled $92.8 million, compared to $43.2 million as of December 31, 2017. Conference Call Information About CTI BioPharma Corp. Non-GAAP Financial Measures 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 2018 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 "CTI BioPharma" and the CTI BioPharma logo are registered trademarks or trademarks of CTI BioPharma Corp. in various jurisdictions. All other trademarks belong to their respective owner. CTI BioPharma Investor Contacts: Rich Allan (media) CTI BioPharma Corp.
Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
(unaudited)
Three Months Ended Six Months Ended
June 30, June 30,
2018 2017 2018 2017
---- ---- ---- ----
Revenues:
Product sales, net $ - $211 $ - $837
License and contract
revenue 613 22,014 11,090 22,142
Total revenues 613 22,225 11,090 22,979
--- ------ ------ ------
Operating costs and expenses:
Cost of product sold 588 78 678 211
Research and development 9,124 8,914 18,809 18,167
Selling, general and
administrative 4,865 7,962 10,274 18,650
Other operating expense
(income) 37 - (334) -
--- --- ---- ---
Total operating costs and
expenses, net 14,614 16,954 29,427 37,028
------ ------ ------ ------
(Loss) income from
operations (14,001) 5,271 (18,337) (14,049)
Non-operating (expense) income:
Interest expense (297) (488) (585) (1,022)
Amortization of debt
discount and issuance
costs (130) (37) (264) (75)
Foreign exchange (loss)
gain (1,575) 657 (852) 614
Other non-operating
income (expense) 4,659 (30) 4,659 (30)
----- --- ----- ---
Total non-operating
(expense) income, net 2,657 102 2,958 (513)
----- --- ----- ----
Net (loss) income before
noncontrolling interest (11,344) 5,373 (15,379) (14,562)
Noncontrolling interest 8 25 22 132
--- --- --- ---
Net (loss) income (11,336) 5,398 (15,357) (14,430)
Deemed dividends on
preferred stock - (4,350) (80) (4,350)
Net (loss) income
attributable to common
stockholders $(11,336) $1,048 $(15,437) $(18,780)
======== ====== ======== ========
Net (loss) income per common share:
Basic $(0.20) $0.03 $(0.29) $(0.63)
====== ===== ====== ======
Diluted $(0.20) $0.03 $(0.29) $(0.63)
====== ===== ====== ======
Shares used in calculation of (loss) income
per common share:
Basic 57,941 31,725 54,148 29,895
====== ====== ====== ======
Diluted 57,941 31,901 54,148 29,895
====== ====== ====== ======
Balance Sheet
Data
(unaudited): (amounts in thousands)
June 30, December 31,
2018 2017
---- ----
Cash, cash
equivalents and
restricted cash $65,374 $43,218
Short-term
investments 27,450 -
Working capital 72,818 27,666
Total assets 102,586 54,886
Current portion
of long-term
debt 2,590 444
Long-term debt,
less current
portion 11,673 13,575
Total
stockholders'
equity 63,648 16,090
Non-GAAP Reconciliations
(In thousands)
(unaudited)
Three Months Ended June 30, Six Months Ended June 30,
2018 2017 2018 2017
---- ---- ---- ----
As reported -(loss)
income from
operations (GAAP) $(14,001) $5,271 $(18,337) $(14,049)
As reported -
share-based
compensation
expense (GAAP) 1,040 1,149 2,376 2,948
As adjusted - loss
from operations
(Non-GAAP) $(12,961) $6,420 $(15,961) $(11,101)
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Company Codes: NASDAQ-SMALL:CTIC |
