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BOSTON--(BUSINESS WIRE)--Mar 22, 2023--
Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, announced today financial results for the three-month period and full year ended December 31, 2022.
Fourth Quarter 2022 and Recent Business Update
“It’s been a transformative year for Spectrum as we have become a commercially focused company. We’ve approached the launch of ROLVEDON with a disciplined strategy and an understanding that Spectrum’s long-term growth is dependent upon the product’s success. We’re off to a solid start and are encouraged by the initial customer receptivity to ROLVEDON,” said Tom Riga, President and Chief Executive Officer of Spectrum Pharmaceuticals. “Commercial success is foundational to the Company’s future and, with the right people in place, a lean infrastructure, and an ample cash runway, we have a tremendous opportunity moving forward.”
Financial Results for the Quarter and Year Ended December 31, 2022 (All numbers are from Continuing Operations)
Net sales for the quarter and year ended December 31, 2022 were $10.1 million as we began to sell our sole commercial product, ROLVEDON, which was approved by the FDA on September 9, 2022.
During the quarter and year ended December 31, 2022, the cost of sales was $1.8 million, consisting primarily of packaging costs, freight and royalties associated with the net sales of ROLVEDON and $1.1 million of start-up expenses associated with stability and bio-burden testing. This figure did not include any direct costs associated with the manufacture of ROLVEDON, which were previously expensed in research and development expense.
Selling, general and administrative expenses for the quarter and year ended December 31, 2022 were $11.3 million and $38.8 million, respectively, as compared to $18.9 million and $60.4 million for the comparable periods in 2021. The decrease was primarily due to lower costs associated with personnel related expenses associated with the reduction in workforce announced in January 2022 and decreases in professional services and other general expenses.
Total research and development expenses were $8.7 million and $42.2 million for the quarter and year ended December 31, 2022, respectively, as compared to $18.0 million and $87.3 million for the comparable periods in 2021. The decrease was due to decreased program activities for ROLVEDON, poziotinib, and early-stage compounds, personnel-related expenditures associated with the reduction in workforce during the strategic restructuring that began in January 2022, as well as a concession provided by Hanmi Pharmaceutical Co. Ltd. for drug substance which had been accrued during 2021 and is no longer payable by Spectrum.
Net loss was $11.7 million, or $0.06 per basic and diluted share, for the quarter ended December 31, 2022, compared to a net loss of $39.8 million, or $0.26 per basic and diluted share, for the comparable period in 2021. Net loss for the year ended December 31, 2022 was $78.1 million, or $0.43 per basic and diluted share, compared to net loss of $158.4 million, or $1.02 per basic and diluted share, for the comparable period in 2021.
The Company had a total cash, cash equivalents, and marketable securities balance of approximately $75.1 million at December 31, 2022.
Conference Call | ||
As previously announced, management will host a conference call as follows: | ||
Date: | Wednesday, March 22, 2023 | |
Time: | 8:30 AM ET | |
Register: | Click Here | |
Webcast (Audio Only): | Click Here |
The webcast will be archived under the "Events and Presentations" section of the Company’s investor relations website.
About ROLVEDON™
ROLVEDON™ (eflapegrastim-xnst) injection is a long-acting granulocyte colony-stimulating factor (G-CSF) with a novel formulation. Spectrum has received an indication to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. ROLVEDON is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. The BLA for ROLVEDON was supported by data from two identically designed Phase 3, randomized, open-label, noninferiority clinical trials, ADVANCE and RECOVER, which evaluated the safety and efficacy of ROLVEDON in 643 early-stage breast cancer patients for the management of neutropenia due to myelosuppressive chemotherapy. In both studies, ROLVEDON demonstrated the pre-specified hypothesis of non-inferiority (NI) in mean duration of severe neutropenia (DSN) and a similar safety profile to pegfilgrastim. ROLVEDON also demonstrated non-inferiority to pegfilgrastim in the mean DSN across all four cycles (all NI p<0.0001) in both trials.
Please see the Important Safety Information below and the full prescribing information for ROLVEDON at www.rolvedon.com.
Indications and Usage
ROLVEDON is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia.
Limitations of Use
ROLVEDON is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
Important Safety Information
Contraindications
Warnings and Precautions
Splenic Rupture
Acute Respiratory Distress Syndrome (ARDS)
Serious Allergic Reactions
Sickle Cell Crisis in Patients with Sickle Cell Disorders
Glomerulonephritis
Leukocytosis
Thrombocytopenia
Capillary Leak Syndrome
Potential for Tumor Growth Stimulatory Effects on Malignant Cells
Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) in Patients with Breast and Lung Cancer
Aortitis
Nuclear Imaging
Adverse Reactions
To report SUSPECTED ADVERSE REACTIONS, contact Spectrum Pharmaceuticals, Inc. at 1-888-713-0688 or FDA at 1800FDA1088 or www.fda.gov/medwatch
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals, Inc. is a commercial stage biopharmaceutical company focused on acquiring, developing, and commercializing novel and targeted oncology therapies. Spectrum has a strong track record of successfully executing across the biopharmaceutical business model, from in-licensing and acquiring differentiated drugs, clinically developing novel assets, successfully gaining regulatory approvals and commercializing in a competitive healthcare marketplace. For additional information on Spectrum please visit www.sppirx.com.
Notice Regarding Forward-looking Statements
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 are based on management's current beliefs and expectations. These statements include, but are not limited to, statements that relate to Spectrum’s fourth quarter and full year financial performance, including Spectrum’s expected net sales, expected cash runway, the future success of Spectrum’s commercial launch of ROLVEDON, and any other 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 Spectrum’s existing and new drug candidates may not prove safe or effective, the possibility that our existing and new applications to the FDA and other regulatory agencies may not receive approval 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 dependence on third parties for clinical trials, manufacturing, distribution and quality control, the impact of the COVID-19 pandemic, geopolitical issues and inflation on our business and operations, supply chain and labor force and other risks that are described in further detail in the Company's reports filed with the Securities and Exchange Commission. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law.For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Spectrum in general, see the risk disclosures in the Annual Report on Form 10-K of Spectrum for the year ended December 31, 2021, and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC by Spectrum.
SPECTRUM PHARMACEUTICALS, INC.® is a registered trademark of Spectrum Pharmaceuticals, Inc. and its affiliates. REDEFINING CANCER CARE™ and ROLVEDON™ are the Spectrum Pharmaceuticals’ logos and trademarks owned by Spectrum Pharmaceuticals, Inc. Any other trademarks are the property of their respective owners.
© 2023 Spectrum Pharmaceuticals, Inc. All Rights Reserved
SPECTRUM PHARMACEUTICALS, INC. Condensed Consolidated Statements of Operations (In thousands, except per share amounts) (Unaudited) | ||||||||||||||||
| Three Months Ended December 31, |
| Twelve Months Ended December 31, | |||||||||||||
| 2022 |
| 2021 |
| 2022 |
| 2021 | |||||||||
Net sales | $ | 10,114 |
|
| $ | — |
|
| $ | 10,114 |
|
| $ | — |
| |
Expenses: |
|
|
|
|
|
|
| |||||||||
Cost of sales |
| 1,792 |
|
|
| — |
|
|
| 1,792 |
|
|
| — |
| |
Selling, general and administrative |
| 11,298 |
|
|
| 18,891 |
|
|
| 38,816 |
|
|
| 60,406 |
| |
Research and development |
| 8,669 |
|
|
| 17,962 |
|
|
| 42,203 |
|
|
| 87,297 |
| |
Total expenses |
| 21,759 |
|
|
| 36,853 |
|
|
| 82,811 |
|
|
| 147,703 |
| |
Loss from continuing operations before other income (expense) and income taxes |
| (11,645 | ) |
|
| (36,853 | ) |
|
| (72,697 | ) |
|
| (147,703 | ) | |
Other income (expense): |
|
|
|
|
|
|
| |||||||||
Interest income |
| 615 |
|
|
| 45 |
|
|
| 968 |
|
|
| 215 |
| |
Interest expense |
| (901 | ) |
|
| (4 | ) |
|
| (998 | ) |
|
| (52 | ) | |
Other expense, net |
| 202 |
|
|
| (2,943 | ) |
|
| (5,331 | ) |
|
| (10,892 | ) | |
Total other expense |
| (84 | ) |
|
| (2,902 | ) |
|
| (5,361 | ) |
|
| (10,729 | ) | |
Loss from continuing operations before income taxes |
| (11,729 | ) |
|
| (39,755 | ) |
|
| (78,058 | ) |
|
| (158,432 | ) | |
Benefit (provision) for income taxes from continuing operations |
| — |
|
|
| 5 |
|
|
| (46 | ) |
|
| (4 | ) | |
Loss from continuing operations | $ | (11,729 | ) |
| $ | (39,750 | ) |
| $ | (78,104 | ) |
| $ | (158,436 | ) | |
Income (loss) from discontinued operations, net of income taxes |
| 2,742 |
|
|
| 36 |
|
|
| 2,703 |
|
|
| (192 | ) | |
Net loss | $ | (8,987 | ) |
| $ | (39,714 | ) |
| $ | (75,401 | ) |
| $ | (158,628 | ) | |
|
|
|
|
|
|
|
| |||||||||
Basic and diluted loss per share: |
|
|
|
|
|
|
| |||||||||
Loss per common share from continuing operations | $ | (0.06 | ) |
| $ | (0.26 | ) |
| $ | (0.43 | ) |
| $ | (1.02 | ) | |
Income per common share from discontinued operations | $ | 0.01 |
|
| $ | — |
|
| $ | 0.01 |
|
| $ | — |
| |
Net loss per common share, basic and diluted | $ | (0.05 | ) |
| $ | (0.26 | ) |
| $ | (0.41 | ) |
| $ | (1.02 | ) | |
|
|
|
|
|
|
|
| |||||||||
Weighted average shares outstanding, basic and diluted |
| 199,539,109 |
|
|
| 154,680,363 |
|
|
| 183,237,200 |
|
|
| 154,861,704 |
|
SPECTRUM PHARMACEUTICALS, INC. Condensed Consolidated Balance Sheets (In thousands, expect per share and par value amounts) | ||||||||
| December 31, | |||||||
| 2022 |
| 2021 | |||||
ASSETS |
|
|
| |||||
Current assets: |
|
|
| |||||
Cash and cash equivalents | $ | 40,368 |
|
| $ | 88,539 |
| |
Marketable securities |
| 34,728 |
|
|
| 12,108 |
| |
Accounts receivable, net |
| 12,996 |
|
|
| — |
| |
Other receivables |
| 617 |
|
|
| 1,028 |
| |
Inventories |
| 9,230 |
|
|
| — |
| |
Prepaid expenses and other current assets |
| 3,072 |
|
|
| 2,277 |
| |
Total current assets |
| 101,011 |
|
|
| 103,952 |
| |
Property and equipment, net |
| 476 |
|
|
| 455 |
| |
Facility and equipment under lease |
| 1,694 |
|
|
| 2,505 |
| |
Other assets |
| 157 |
|
|
| 4,636 |
| |
Total assets | $ | 103,338 |
|
| $ | 111,548 |
| |
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
| |||||
Current liabilities: |
|
|
| |||||
Accounts payable and other accrued liabilities | $ | 38,105 |
|
| $ | 41,258 |
| |
Accrued payroll and benefits |
| 4,580 |
|
|
| 11,971 |
| |
Total current liabilities |
| 42,685 |
|
|
| 53,229 |
| |
Loan payable, long-term |
| 28,666 |
|
|
| — |
| |
Other long-term liabilities |
| 4,099 |
|
|
| 10,766 |
| |
Total liabilities |
| 75,450 |
|
|
| 63,995 |
| |
Commitments and contingencies |
|
|
| |||||
Stockholders’ equity: |
|
|
| |||||
Preferred stock, $0.001 par value; 5,000,000 shares authorized; no shares issued and outstanding |
| — |
|
|
| — |
| |
Common stock, $0.001 par value; 300,000,000 shares authorized; 202,827,831 and 164,502,013 issued and outstanding at December 31, 2022 and 2021, respectively |
| 203 |
|
|
| 165 |
| |
Additional paid-in capital |
| 1,149,926 |
|
|
| 1,094,353 |
| |
Accumulated other comprehensive loss |
| (2,917 | ) |
|
| (3,042 | ) | |
Accumulated deficit |
| (1,119,324 | ) |
|
| (1,043,923 | ) | |
Total stockholders’ equity |
| 27,888 |
|
|
| 47,553 |
| |
Total liabilities and stockholders’ equity | $ | 103,338 |
|
| $ | 111,548 |
|
View source version on businesswire.com:https://www.businesswire.com/news/home/20230322005339/en/
CONTACT: Nora Brennan
Chief Financial Officer
949.788.6700
InvestorRelations@sppirx.comLisa Wilson
In-Site Communications, Inc.
212.452.2793
lwilson@insitecony.com
KEYWORD: UNITED STATES NORTH AMERICA MASSACHUSETTS
INDUSTRY KEYWORD: BIOTECHNOLOGY PHARMACEUTICAL HEALTH
SOURCE: Spectrum Pharmaceuticals, Inc.
Copyright Business Wire 2023.
PUB: 03/22/2023 08:00 AM/DISC: 03/22/2023 08:03 AM
http://www.businesswire.com/news/home/20230322005339/en