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8-K - FORM 8-K - SPECTRUM PHARMACEUTICALS INC | c07745e8vk.htm |
Exhibit 99.1
COMPANY CONTACTS
Paul Arndt
Senior Manager, Investor Relations
949-788-6700x216
Paul Arndt
Senior Manager, Investor Relations
949-788-6700x216
SPECTRUM PHARMACEUTICALS ANNOUNCES THIRD QUARTER 2010 FINANCIAL AND OPERATING RESULTS
| Strong Financial Results Include 174% Increase in 3Q10 Total Product Revenue Vs. 3Q09 | ||
| 64% Increase in 3Q10 ZEVALIN® Revenue Vs. 3Q09 | ||
| 47% Sequential Increase In Total Product Revenue Over 2Q10 | ||
| Three and Nine-Month 2010 Consolidated Revenues Approximately $16.7 Million and $40.2 Million, Respectively | ||
| Three and Nine-Month 2010 Product Revenues Approximately $13.7 Million and $30.1 Million, Respectively | ||
| Approximately $92 Million in Cash, Cash Equivalents and Investments as of September 30, 2010 | ||
| Submitted FUSILEV Data in Colorectal Cancer in October 2010 |
IRVINE, California November 4, 2010 Spectrum Pharmaceuticals, Inc. (NasdaqGM: SPPI), a
biotechnology company with fully integrated commercial and drug development operations with a
primary focus in oncology, today reported financial results for the three and nine-months ended
September 30, 2010.
We are pleased with our accomplishments in the third quarter and year-to-date, said Rajesh C.
Shrotriya, M.D., Chairman of the Board of Directors, Chief Executive Officer, and President of
Spectrum Pharmaceuticals, Inc. We achieved record total product revenue and quarterly sales of
ZEVALIN. We also submitted a response to the Complete Response letter for FUSILEV®
for advanced metastatic colorectal cancer treatment. Lastly, we further strengthened our
management team. We appointed Brett Scott, a proven healthcare executive, as our Acting Chief
Financial Officer, to build and expand upon the existing financial and accounting infrastructure to
support product revenue growth from our FDA approved anticancer drugs.
We are continuing to see benefits from the sales force optimization program put in place by our
Chief Commercial Officer, Jim Shields, to maximize our return on investment, continued Shrotriya.
Before year end, we expect to file the data supporting removal of the bioscan requirement for
ZEVALIN. We expect additional FDA filings in 2011 and 2012 for belinostat and apaziquone,
respectively.
We believe that the steps we have taken will help us achieve our mission of bringing more effective
treatments to cancer patients as quickly as possible.
Third Quarter Results Ended September 30, 2010 (All #s are approximates)
During the three-month period ended September 30, 2010, net cash, cash equivalents and investments used was approximately $2.5 million.
During the three-month period ended September 30, 2010, net cash, cash equivalents and investments used was approximately $2.5 million.
Consolidated revenue of $16.7 million was comprised of product sales of $13.7 million ($7.7 million
from ZEVALIN, $6.0 million from FUSILEV) and $3.1 million from licensing fees. This compares to
$7.1 million in consolidated revenue in the third quarter of 2009, which was comprised of $5.0
million from product sales ($4.7 million from ZEVALIN, $0.3 million from FUSILEV) and $2.1 million
from licensing fees. The Company recorded a net loss of $4.6 million, or ($0.09) per basic and
diluted share, compared to net income of $474 thousand, or $0.01 per basic and ($0.07) per diluted
share, in the third quarter of 2009. Total research and development expenses were $7.5 million, as
compared to $5.5 million in the same period of 2009, primarily due to a non-cash charge of $1.7
million related to acquisition of intellectual property in the third quarter of 2010. Selling,
general and administrative expenses were $11.4 million compared to $7.0 million in the same period in 2009 an increase
primarily due to commercial activities.
157 Technology Dr Irvine, California 92618 Tel: 949-788-6700 Fax: 949-788-6706 www.sppirx.com NASDAQ: SPPI
Nine-Month Results Ended September 30, 2010 (All #s are approximates)
During the nine-month period ended September 30, 2010, net cash used in operations was approximately $32.8 million, including the one-time upfront payment of $30 million for belinostat.
During the nine-month period ended September 30, 2010, net cash used in operations was approximately $32.8 million, including the one-time upfront payment of $30 million for belinostat.
Consolidated revenue of $40.2 million was comprised of product sales of $30.1 million ($21.1 million from ZEVALIN, $9.0 million from FUSILEV) and $10.1 million from licensing fees. This
compares to $29.4 million in consolidated revenue in the same nine-month period of 2009, which was
comprised of $23.0 million from product sales ($10.6 million from ZEVALIN, $12.4 million from
FUSILEV) and $6.4 million from licensing fees. The Company recorded a net loss of $53.3 million,
or ($1.08) per basic and diluted share, compared to a net loss of $29.2 million, or ($0.80) per
basic and diluted share, in the same nine-month period of 2009. Research and development expenses
were $50.3 million, as compared to $17.5 million in the same period of 2009, an increase primarily
related to the $30 million one-time, upfront license fee for belinostat. Selling, general and
administrative expenses were $36.1 million compared to $22.5 million in the same period in 2009, an
increase primarily due to commercial activities.
Cash, cash equivalents, and investments in marketable securities, including long-term bank
certificates of deposits, totaled $92 million as of September 30, 2010.
There are approximately 50 million shares of common stock issued and outstanding.
Company Accomplishments, Goals and Upcoming Milestones
ZEVALIN
ZEVALIN
| Continue to grow the brand; | ||
| Submit to the FDA data supporting removal of the bioscan requirement; and, | ||
| Continue to evaluate and design clinical trial strategies to expand ZEVALINs approved indications to treat additional patient populations. |
FUSILEV
| Submitted response on October 29, 2010, to FDAs complete response letter for its use in colorectal cancer; and, | ||
| Currently expect FDA to render a decision in 2011. |
Apaziquone
| Top-line data from the registrational Phase 3 bladder cancer trials is expected in 2012. |
Belinostat
| Peripheral T-Cell Lymphoma Anticipate NDA filing in 2011. | ||
| Carcinoma of Unknown Primary TopoTarget on track to complete enrollment by year-end 2010 in the ongoing Phase 2 CUP trial. |
Conference Call
Thursday, November 4, 2010 @ 1:00 p.m. Eastern/10:00 a.m. Pacific
Domestic:
|
(877) 837-3910 | |
International:
|
(973) 796-5077 |
Webcast and replays: www.sppirx.com
Audio replays will be available through December 1, 2010 | ||
Domestic:
|
(800) 642-1687, passcode 10149788 | |
International:
|
(706) 645-9291, passcode 10149788 |
157 Technology Dr Irvine, California 92618 Tel: 949-788-6700 Fax: 949-788-6706 www.sppirx.com NASDAQ: SPPI
About ZEVALIN® and the ZEVALIN Therapeutic Regimen
ZEVALIN (ibritumomab tiuxetan) is indicated for the treatment of patients with previously untreated follicular non-Hodgkins Lymphoma (NHL), who achieve a partial or complete response to first-line chemotherapy. ZEVALIN is also indicated for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkins lymphoma.
ZEVALIN (ibritumomab tiuxetan) is indicated for the treatment of patients with previously untreated follicular non-Hodgkins Lymphoma (NHL), who achieve a partial or complete response to first-line chemotherapy. ZEVALIN is also indicated for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkins lymphoma.
ZEVALIN is a CD20-directed radiotherapeutic antibody. The ZEVALIN therapeutic regimen consists of
three components: rituximab, Indium-111 (In-111) radiolabeled ZEVALIN for imaging, and Yttrium-90
(Y-90) radiolabeled ZEVALIN for therapy. The ZEVALIN therapeutic regimen is a form of cancer
therapy called radioimmunotherapy. Radioimmunotherapy (RIT) is an innovative form of cancer
treatment with a mechanism of action that is different from traditional chemotherapy. RIT builds on
the combined effect of a targeted biologic monoclonal antibody augmented with the therapeutic
effects of a beta-emitting radioisotope.
Full prescribing information can be found at www.ZEVALIN.com.
About FUSILEV® (levoleucovorin) for Injection
FUSILEV, a novel folate analog, is available in vials for injection as freeze-dried powder. FUSILEV rescue is indicated after high-dose methotrexate therapy in osteosarcoma. FUSILEV is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists. FUSILEV (levoleucovorin or (6S)-leucovorin) is the only commercially available formulation containing only the pharmacologically active isomer of leucovorin.
FUSILEV, a novel folate analog, is available in vials for injection as freeze-dried powder. FUSILEV rescue is indicated after high-dose methotrexate therapy in osteosarcoma. FUSILEV is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists. FUSILEV (levoleucovorin or (6S)-leucovorin) is the only commercially available formulation containing only the pharmacologically active isomer of leucovorin.
Full prescribing information can be found at www.FUSILEV.com.
About Spectrum Pharmaceuticals
Spectrum Pharmaceuticals is a biotechnology company with fully integrated commercial and drug
development operations with a primary focus in oncology. The Companys strategy is comprised of
acquiring, developing and commercializing a broad and diverse pipeline of late-stage clinical and
commercial products. The Company markets two oncology drugs, FUSILEV and ZEVALIN and has two
drugs, apaziquone and belinostat, in late stage development along with a diversified pipeline of
novel drug candidates. The Company has assembled an integrated in-house scientific team, including
clinical development, medical research, regulatory affairs, biostatistics and data management,
formulation development, and has established a commercial infrastructure for the marketing of its
drug products. The Company also leverages the expertise of its worldwide partners to assist in the
execution of its strategy. For more information, please visit the Companys website at
www.sppirx.com.
Forward-looking statement This press release may contain forward-looking statements regarding
future events and the future performance of Spectrum Pharmaceuticals that involve risks and
uncertainties that could cause actual results to differ materially. These statements include but
are not limited to statements that relate to our business and its future, including certain company
milestones, Spectrums ability to identify, acquire, develop and commercialize a broad and diverse
pipeline of late-stage clinical and commercial products, leveraging the expertise of partners and
employees, around the world to assist us in the execution of our strategy, and any statements that
relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not
a statement of historical fact. Risks that could cause actual results to differ include the
possibility that our existing and new drug candidates, may not prove safe or effective, the
possibility that our existing and new drug candidates may not receive approval from the FDA, and
other regulatory agencies in a timely manner or at all, the possibility that our existing and new
drug candidates, if approved, may not be more effective, safer or more cost efficient than
competing drugs, the possibility that our efforts to acquire or in-license and develop additional
drug candidates may fail, our lack of revenues, our limited marketing experience, our dependence on
third parties for clinical trials, manufacturing, distribution and quality control and other risks
that are described in further detail in the Companys reports filed with the Securities and
Exchange Commission. We do not plan to update any such forward-looking statements and expressly
disclaim any duty to update the information contained in this press release except as required by
law.
SPECTRUM PHARMACEUTICALS, INC. ®, ZEVALIN®, and FUSILEV® are registered trademarks of Spectrum
Pharmaceuticals, Inc. REDEFINING CANCER CARE and the Spectrum Pharmaceutical logos are trademarks
owned by Spectrum Pharmaceuticals, Inc.
© 2010 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
157 Technology Dr Irvine, California 92618 Tel: 949-788-6700 Fax: 949-788-6706 www.sppirx.com NASDAQ: SPPI
SPECTRUM PHARMACEUTICALS, INC. AND SUBSIDIARIES
(In thousands, except Share and per share data)
Summary Condensed Consolidated Statement of Operations (Unaudited)
(In thousands, except shares and per share data) | ||||||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2010 | 2009 | 2010 | 2009 | |||||||||||||
Revenues: |
||||||||||||||||
Product sales, net |
$ | 13,660 | $ | 4,976 | $ | 30,050 | $ | 23,030 | ||||||||
License and contract revenue |
3,075 | 2,125 | 10,117 | 6,375 | ||||||||||||
Total revenues |
16,735 | 7,101 | 40,167 | 29,405 | ||||||||||||
Operating costs and expenses: |
||||||||||||||||
Cost of product sales (excludes amortization of
purchased intangibles assets) |
3,789 | 2,429 | 10,626 | 5,702 | ||||||||||||
Selling general and administrative |
11,411 | 6,995 | 36,075 | 22,538 | ||||||||||||
Research and development |
7,485 | 5,488 | 50,314 | 17,533 | ||||||||||||
Amortization of purchased intangibles |
930 | 950 | 2,790 | 2,850 | ||||||||||||
Total operating costs and expenses |
23,615 | 15,862 | 99,805 | 48,623 | ||||||||||||
Loss from operations |
(6,880 | ) | (8,761 | ) | (59,638 | ) | (19,218 | ) | ||||||||
Change in fair value of common stock warrant liability |
1,629 | 8,863 | 6,030 | (11,759 | ) | |||||||||||
Other income, net |
578 | 372 | 245 | 601 | ||||||||||||
Net (loss) income before provision for income taxes |
(4,673 | ) | 474 | (53,363 | ) | (30,376 | ) | |||||||||
Provision for income tax |
79 | | 79 | | ||||||||||||
Net loss attributable to non-controlling interest |
| | | 1,146 | ||||||||||||
Net (loss) income attributable to Spectrum
Pharmaceuticals, Inc. stockholders |
$ | (4,594 | ) | $ | 474 | $ | (53,284 | ) | $ | (29,230 | ) | |||||
Net (loss) income per share |
||||||||||||||||
Basic |
$ | (0.09 | ) | $ | 0.01 | $ | (1.08 | ) | $ | (0.80 | ) | |||||
Diluted |
$ | (0.09 | ) | $ | (0.07 | ) | $ | (1.08 | ) | $ | (0.80 | ) | ||||
Weighted average common shares outstanding |
||||||||||||||||
Basic |
49,739,072 | 42,364,983 | 49,146,245 | 36,189,156 | ||||||||||||
Diluted |
49,739,072 | 44,191,257 | 49,146,245 | 36,189,156 | ||||||||||||
Summary Condensed Consolidated Balance Sheets (Unaudited) |
||||||||||||||||
September 30, | December 31, | |||||||||||||||
2010 | 2009 | |||||||||||||||
Cash, cash equivalents and marketable securities |
$ | 84,596 | $ | 113,341 | ||||||||||||
Accounts receivable, net |
9,465 | 8,658 | ||||||||||||||
Inventories, net |
3,795 | 3,230 | ||||||||||||||
Other current assets |
1,080 | 1,028 | ||||||||||||||
Total current assets |
98,936 | 126,257 | ||||||||||||||
Bank certificates of deposit & treasuries |
7,376 | 11,438 | ||||||||||||||
Intangible assets, net |
30,535 | 33,325 | ||||||||||||||
Property and equipment, net and other assets |
3,645 | 2,113 | ||||||||||||||
Total assets |
$ | 140,492 | $ | 173,133 | ||||||||||||
Current liabilities |
$ | 47,038 | $ | 39,499 | ||||||||||||
Commitments & Contingencies |
| | ||||||||||||||
Deferred revenue, other credits and liabilities |
29,063 | 25,310 | ||||||||||||||
Stockholders equity |
64,391 | 108,324 | ||||||||||||||
Total liabilities and stockholders equity |
$ | 140,492 | $ | 173,133 | ||||||||||||
157 Technology Dr Irvine, California 92618 Tel: 949-788-6700 Fax: 949-788-6706 www.sppirx.com NASDAQ: SPPI