Full Press Release Details
Galena Biopharma Reports Third Quarter 2014 Results
Portland, Oregon, November 3, 2014 - Galena Biopharma, Inc. (NASDAQ: GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today reported its financial results for the quarter ended September 30, 2014 and provided a business update.
"The company continues to make excellent progress on our clinical programs, and we continue to build our commercial franchise," said Mark W. Schwartz, Ph.D., President and Chief Executive Officer. "I believe we have turned the corner on the corporate challenges we faced this year, and we are fully focused on the progress of NeuVax and its portfolio of clinical trials, our development pipeline and our commercial programs including the upcoming launch of Zuplenz . Over the next six months, we will report results from the ongoing trials with GALE-301 and GALE-401, and our NeuVax platform will expand with the initiation of two new trials plus the completion of enrollment in our pivotal, Phase 3 PRESENT study. The launch of Zuplenz in Q1 2015 enhances our commercialization efforts and we believe we will see significant sales growth for that business line in 2015."
Galena will host a conference call today at 2:00 p.m. P.T./5:00 p.m. E.T. to discuss financial and business results. The call can be accessed by dialing (844) 825-4413 toll-free in the U.S., or (973) 638-3403 for participants outside the U.S. The Conference ID number is: 23451769. The conference call will also be webcast live and available under the Investors section/Events and Presentations on the Company's website at www.galenabiopharma.com. The archived webcast replay will be available on the Company's website for 90 days.
Third Quarter 2014 Financial Highlights
Net revenue for the third quarter of 2014 was $1.6 million compared to $1.2 million for the third quarter of 2013, an increase of 25%. Net revenue for the nine months ended September 30, 2014 was $6.1 million. The third quarter of 2013 was the first quarter that the company experienced net revenue.
Operating loss for the three months ended September 30, 2014 was $13.2 million, including $1.3 million in stock-based compensation charges, compared to $6.9 million, including $0.5 million in stock-based compensation charges, for the three months ended September 30, 2013.
Galena also incurs non-cash income and expense related to changes in the fair value estimates of the Company's warrant liabilities. Non-cash income related to the change in warrant values for the three months ended September 30, 2014 was $6.7 million compared to non-cash expense of $1.6 million for the three months ended September 30, 2013.
Net loss for the three months ended September 30, 2014 was $6.2 million, or $0.05 per basic and diluted share, compared to a net loss of $9.3 million, or $0.11 per basic and diluted share, for the three months ended September 30, 2013.
As of September 30, 2014, Galena had cash and cash equivalents of $24.6 million, compared with $47.8 million as of December 31, 2013.
GALENA BIOPHARMA, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands, except share and per share data)
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
| 2014 | 2013 | 2014 | 2013 | ||||||||||||
| Net revenue | $ | 1,620 | $ | 1,170 | $ | 6,124 | $ | 1,170 | |||||||
| Costs and expenses: | |||||||||||||||
| Cost of revenue (excluding amortization of certain acquired intangible assets) | 247 | 258 | 925 | 258 | |||||||||||
| Research and development | 7,243 | 3,633 | 22,082 | 13,990 | |||||||||||
| Selling, general, and administrative | 7,268 | 4,129 | 23,698 | 8,369 | |||||||||||
| Amortization of certain acquired intangible assets | 70 | 43 | 259 | 43 | |||||||||||
| Total costs and expenses | 14,828 | 8,063 | 46,964 | 22,660 | |||||||||||
| Operating loss | (13,208 | ) | (6,893 | ) | (40,840 | ) | (21,490 | ) | |||||||
| Non-operating income (expense): | |||||||||||||||
| Change in fair value of warrants potentially settleable in cash | 6,735 | (1,614 | ) | 13,174 | (7,135 | ) | |||||||||
| Interest income (expense), net | (297 | ) | (314 | ) | (925 | ) | (495 | ) | |||||||
| Other income (expense) | 597 | 693 | (59 | ) | 881 | ||||||||||
| Total non-operating income (expense), net | 7,035 | (1,235 | ) | 12,190 | (6,749 | ) | |||||||||
| Loss before income taxes | (6,173 | ) | (8,128 | ) | (28,650 | ) | (28,239 | ) | |||||||
| Income tax benefit | - | 1,159 | - | (62 | ) | ||||||||||
| Net loss | $ | (6,173 | ) | $ | (9,287 | ) | $ | (28,650 | ) | $ | (28,177 | ) | |||
| Net loss per common share: | |||||||||||||||
| Basic and diluted net loss per share | $ | (0.05 | ) | $ | (0.11 | ) | $ | (0.24 | ) | $ | (0.33 | ) | |||
| Weighted-average common shares outstanding: basic and diluted | 119,038,656 | 87,319,450 | 117,767,791 | 84,678,612 |
GALENA BIOPHARMA, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands)
| September 30, 2014 | |||||||
| (Unaudited) | December 31, 2013 | ||||||
| ASSETS | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 24,647 | $ | 47,787 | |||
| Restricted cash | 200 | 200 | |||||
| Accounts receivable | 1,435 | 3,683 | |||||
| Inventories | 450 | 386 | |||||
| Prepaid expenses | 1,789 | 1,399 | |||||
| Total current assets | 28,521 | 53,455 | |||||
| Equipment and furnishings, net | 589 | 665 | |||||
| In-process research and development | 12,864 | 12,864 | |||||
| Abstral rights, net | 14,714 | 14,979 | |||||
| Zuplenz rights | 7,663 | - | |||||
| GALE-401 rights | 9,155 | - | |||||
| Goodwill | 5,898 | 5,898 | |||||
| Deposits and other assets | 88 | 115 | |||||
| Total assets | $ | 79,492 | $ | 87,976 | |||
| LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 3,360 | $ | 2,660 | |||
| Accrued expenses and other current liabilities | 15,292 | 8,667 | |||||
| Current maturities of capital lease obligations | 6 | 6 | |||||
| Fair value of warrants potentially settleable in cash | 8,765 | 48,965 | |||||
| Current portion of long-term debt | 4,163 | 2,149 | |||||
| Total current liabilities | 31,586 | 62,447 | |||||
| Capital lease obligations, net of current maturities | 17 | 26 | |||||
| Deferred tax liability | 5,053 | 5,053 | |||||
| Contingent purchase price consideration, net of current portion | 6,880 | 6,821 | |||||
| Long-term debt, net of current portion | 5,097 | 7,743 | |||||
| Total liabilities | 48,633 | 82,090 | |||||
| Total stockholders' equity | 30,859 | 5,886 | |||||
| Total liabilities and stockholders' equity | $ | 79,492 | $ | 87,976 |
About Galena Biopharma
Galena Biopharma, Inc. (NASDAQ: GALE) is a biopharmaceutical company developing and commercializing innovative, targeted oncology therapeutics that address major medical needs across the full spectrum of cancer care. Galena's development portfolio ranges from mid- to late-stage clinical assets, including a robust immunotherapy program led by NeuVax (nelipepimut-S) currently in an international, Phase 3 clinical trial. The Company's commercial drugs include Abstral (fentanyl) Sublingual Tablets and Zuplenz (ondansetron) Oral Soluble Film. Collectively, Galena's clinical and commercial strategy focuses on identifying and advancing therapeutic opportunities to improve cancer care, from direct treatment of the disease to the reduction of its debilitating side-effects. For more information visit www.galenabiopharma.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about our 2014 revenue from the sale of Abstral , our planned launch of Zuplenz , the issuance of patents, and the progress of development of Galena's product candidates, including patient enrollment in our clinical trials. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those identified under "Risk Factors" in Galena's Annual Report on Form 10-K for the year ended December 31, 2013 and most recent Quarterly Reports on Form 10-Q filed with the SEC. Actual results may differ materially from those contemplated by these forward-looking statements. Galena does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this press release.
NeuVax is a trademark of Galena Biopharma, Inc. All other trademarks are the property of their respective owners.
VP, Marketing & Communications