Spectrum Pharmaceuticals Reports Third Quarter 2022 Financial Results and Provides Corporate Update
Spectrum Pharmaceuticals (SPPI) announced the commercial launch of ROLVEDON™ (eflapegrastim-xnst), targeting a $2 billion market for adult patients undergoing myelosuppressive anti-cancer treatments. The company reported a significant reduction in research and development expenses, down to $13.3 million from $20.9 million year-over-year. Spectrum's cash position is solid at $100.3 million, extending its runway through 2024. However, the company's poziotinib faced setbacks with a 9-4 ODAC vote deeming its risks outweigh its benefits, with a PDUFA date set for November 24, 2022.
- Launch of ROLVEDON in a $2 billion market.
- Reduction in R&D expenses from $20.9 million to $13.3 million.
- Cash balance of $100.3 million extends runway through 2024.
- Poziotinib received a negative ODAC vote (9-4), questioning its risk-benefit profile.
-- ROLVEDON™ (eflapegrastim-xnst) injection is now commercially available --
-- Cash runway expected to extend through 2024 --
-- Management to host webcast and conference call today at
Third Quarter 2022 and Recent Business Update
-
Launched ROLVEDON™ (eflapegrastim-xnst) injection for adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia into an estimated approximately
$2 billion -
Closed on debt financing with
SLR Capital Partners, LLC (SLR) for a term loan facility of up to$65 million $30 million -
As of
September 30, 2022 , the Company had$100.3 million -
The
U.S. Food and Drug Administration’s (“FDA”)Oncologic Drugs Advisory Committee (“ODAC”) reviewed poziotinib for the treatment of patients with previously treated locally advanced or metastatic non-small cell lung cancer (“NSCLC”) harboring HER2 exon 20 insertion mutations and voted 9-4 that the current benefits of poziotinib do not outweigh its risks. The PDUFA date for poziotinib is scheduled forNovember 24, 2022 .
“The approval of ROLVEDON marks a significant accomplishment for Spectrum and our partner Hanmi Pharmaceutical. We are proud that the product became commercially available in October and are excited to be competing in an estimated
Three-Month Period Ended
Total research and development expenses were
Selling, General and Administrative expenses were
Spectrum recorded a net loss of
Cash Position and Guidance
The Company had a total cash, cash equivalents, and marketable securities balance of approximately
Conference Call
As previously announced, management will host a conference call as follows:
Date: |
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Time: |
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Register (Audio Only): |
The webcast will be archived under the "Events and Presentations” section of the Company’s investor relations website.
About
Notice Regarding Forward-looking Statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. These forward-looking statements relate to a variety of matters, including, without limitation, statements that relate to Spectrum’s business and its future, including the likelihood and timing of the FDA approval of poziotinib, if FDA approval is received, the success and timing of the company’s commercialization efforts, the success of the company’s commercial launch of ROLVEDON, the expected size of the company’s market opportunity for ROLVEDON, the future potential of Spectrum’s existing drug pipeline, the results of the company’s strategic restructuring, the length of the company’s cash runway and other statements that are not purely statements of historical fact. These forward-looking statements are made on the basis of the current beliefs, expectations, and assumptions of the management of Spectrum and are subject to significant risks and uncertainties that could cause actual results to differ materially from what may be expressed or implied in these forward-looking statements. Risks that could cause actual results to differ include, but are not limited to, the uncertainties inherent in new product development, including clinical trial results and additional analysis of existing preclinical and clinical data, the possibility that Spectrum's new and existing drug candidates, including poziotinib, may not ultimately prove to be safe or effective, the possibility that Spectrum's new and existing drug candidates, if approved, may not be more effective, safer, or more cost-efficient than competing drugs and other risks that are described in further detail in the company's reports filed with the
© 2022
Condensed Consolidated Statements of Operations (In thousands, except share and per share amounts) (Unaudited) |
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Three Months Ended
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Nine Months Ended
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2022 |
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2021 |
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|
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2022 |
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|
2021 |
|
Operating costs and expenses: |
|
|
|
|
||||||||||||
Selling, general and administrative |
$ |
8,263 |
|
$ |
12,243 |
|
$ |
27,518 |
|
$ |
41,515 |
|
||||
Research and development |
|
13,335 |
|
|
20,850 |
|
|
33,535 |
|
|
69,335 |
|
||||
Total operating costs and expenses |
|
21,598 |
|
|
33,093 |
|
|
61,053 |
|
|
110,850 |
|
||||
Loss from continuing operations before other income (expense) and income taxes |
|
(21,598 |
) |
|
(33,093 |
) |
|
(61,053 |
) |
|
(110,850 |
) |
||||
Other income (expense): |
|
|
|
|
||||||||||||
Interest income, net |
|
128 |
|
|
11 |
|
|
256 |
|
|
121 |
|
||||
Other income (expense), net |
|
(443 |
) |
|
9 |
|
|
(5,534 |
) |
|
(7,948 |
) |
||||
Total other income (expense) |
|
(315 |
) |
|
20 |
|
|
(5,278 |
) |
|
(7,827 |
) |
||||
Loss from continuing operations before income taxes |
|
(21,913 |
) |
|
(33,073 |
) |
|
(66,331 |
) |
|
(118,677 |
) |
||||
Provision for income taxes from continuing operations |
|
(16 |
) |
|
— |
|
|
(45 |
) |
|
(9 |
) |
||||
Loss from continuing operations |
|
(21,929 |
) |
|
(33,073 |
) |
|
(66,376 |
) |
|
(118,686 |
) |
||||
Income (loss) from discontinued operations, net of income taxes |
|
4 |
|
|
(11 |
) |
|
(39 |
) |
|
(227 |
) |
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Net loss |
$ |
(21,925 |
) |
$ |
(33,084 |
) |
$ |
(66,415 |
) |
$ |
(118,913 |
) |
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|
|
|
|
|
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Basic and diluted loss per share: |
|
|
|
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Loss from continuing operations |
$ |
(0.12 |
) |
$ |
(0.21 |
) |
$ |
(0.37 |
) |
$ |
(0.77 |
) |
||||
Income (loss) from discontinued operations |
$ |
0.00 |
|
$ |
(0.00 |
) |
$ |
(0.00 |
) |
$ |
(0.00 |
) |
||||
Net loss per share, basic and diluted |
$ |
(0.12 |
) |
$ |
(0.21 |
) |
$ |
(0.37 |
) |
$ |
(0.78 |
) |
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Weighted average shares outstanding, basic and diluted |
|
188,358,072 |
|
|
159,261,818 |
|
|
177,818,168 |
|
|
153,341,854 |
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Condensed Consolidated Balance Sheets (In thousands, except share and par value amounts) (Unaudited) |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
$ |
56,255 |
|
$ |
88,539 |
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Marketable securities |
|
43,997 |
|
|
12,108 |
|
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Other receivables |
|
586 |
|
|
1,028 |
|
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Inventories |
|
9,373 |
|
|
— |
|
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Prepaid expenses and other current assets |
|
2,769 |
|
|
2,277 |
|
||
Total current assets |
|
112,980 |
|
|
103,952 |
|
||
Property and equipment, net |
|
422 |
|
|
455 |
|
||
Facility and equipment under lease |
|
1,869 |
|
|
2,505 |
|
||
Other assets |
|
3,658 |
|
|
4,636 |
|
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Total assets |
$ |
118,929 |
|
$ |
111,548 |
|
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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|
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Current liabilities: |
|
|
||||||
Accounts payable and other accrued liabilities |
$ |
42,011 |
|
$ |
41,258 |
|
||
Accrued payroll and benefits |
|
7,613 |
|
|
11,971 |
|
||
Total current liabilities |
|
49,624 |
|
|
53,229 |
|
||
Loan payable, long-term |
|
28,488 |
|
|
— |
|
||
Other long-term liabilities |
|
4,965 |
|
|
10,766 |
|
||
Total liabilities |
|
83,077 |
|
|
63,995 |
|
||
Commitments and contingencies |
|
|
||||||
Stockholders’ equity: |
|
|
||||||
Preferred stock, |
|
— |
|
|
— |
|
||
Common stock, |
|
203 |
|
|
165 |
|
||
Additional paid-in capital |
|
1,148,996 |
|
|
1,094,353 |
|
||
Accumulated other comprehensive loss |
|
(3,009 |
) |
|
(3,042 |
) |
||
Accumulated deficit |
|
(1,110,338 |
) |
|
(1,043,923 |
) |
||
Total stockholders’ equity |
|
35,852 |
|
|
47,553 |
|
||
Total liabilities and stockholders’ equity |
$ |
118,929 |
|
$ |
111,548 |
|
||
View source version on businesswire.com: https://www.businesswire.com/news/home/20221110006012/en/
Chief Executive Officer
949.788.6700
InvestorRelations@sppirx.com
212.452.2793
lwilson@insitecony.com
Source:
FAQ
What is the significance of ROLVEDON's launch for SPPI?
What were SPPI's financial results for the third quarter of 2022?
How does the FDA's ODAC vote affect SPPI's poziotinib?
What is the cash position of SPPI as of September 30, 2022?
When is the PDUFA date for poziotinib?
