-- First launch quarter for ROLVEDON™
(eflapegrastim-xnst) injection --
-- Q4 and full year net sales of $10.1 million
--
-- Management to host webcast and conference
call today at 8:30 a.m. ET / 5:30 a.m. PT --
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
- First launch quarter for ROLVEDON, with net sales for the
quarter and year ended December 31, 2022, totaling $10.1
million.
- Operating expenses decreased 45% year-over-year as the Company
streamlined operations while continuing to invest in core business
objectives, including the commercialization of ROLVEDON.
- 70 targeted accounts purchased ROLVEDON during the launch
quarter, including the top three community oncology networks,
representing approximately 22% of the total clinic market.
- Received permanent J-Code, facilitating more efficient and
predictable reimbursement in the outpatient setting.
- National Comprehensive Cancer Network® Supportive Care
Guidelines (NCCN Guidelines) in oncology for Hematopoietic Growth
Factors named ROLVEDON as an appropriate option for cancer patients
who are at risk for febrile neutropenia.
- Cash, cash equivalents and marketable securities of $75.1
million at December 31, 2022, giving us an expected runway through
2024.
“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
- ROLVEDON is contraindicated in patients with a history of
serious allergic reactions to eflapegrastim, pegfilgrastim or
filgrastim products. Reactions may include anaphylaxis.
Warnings and Precautions
Splenic Rupture
- Splenic rupture, including fatal cases, can occur following the
administration of recombinant human granulocyte colony-stimulating
factor (rhG-CSF) products. Evaluate patients who report left upper
abdominal or shoulder pain for an enlarged spleen or splenic
rupture.
Acute Respiratory Distress Syndrome (ARDS)
- ARDS can occur in patients receiving rhG-CSF products. Evaluate
patients who develop fever, lung infiltrates, or respiratory
distress. Discontinue ROLVEDON in patients with ARDS.
Serious Allergic Reactions
- Serious allergic reactions, including anaphylaxis, can occur in
patients receiving rhG-CSF products. Permanently discontinue
ROLVEDON in patients who experience serious allergic
reactions.
Sickle Cell Crisis in Patients with Sickle Cell
Disorders
- Severe and sometimes fatal sickle cell crises can occur in
patients with sickle cell disorders receiving rhG-CSF products.
Discontinue ROLVEDON if sickle cell crisis occurs.
Glomerulonephritis
- Glomerulonephritis has occurred in patients receiving rhG-CSF
products. The diagnoses were based upon azotemia, hematuria
(microscopic and macroscopic), proteinuria, and renal biopsy.
Generally, events of glomerulonephritis resolved after
dose-reduction or discontinuation. Evaluate and consider dose
reduction or interruption of ROLVEDON if causality is likely.
Leukocytosis
- White blood cell (WBC) counts of 100 x 109/L or greater have
been observed in patients receiving rhG-CSF products. Monitor
complete blood count (CBC) during ROLVEDON therapy. Discontinue
ROLVEDON treatment if WBC count of 100 x 109/L or greater
occurs.
Thrombocytopenia
- Thrombocytopenia has been reported in patients receiving
rhG-CSF products. Monitor platelet counts.
Capillary Leak Syndrome
- Capillary leak syndrome has been reported after administration
of rhG-CSF products and is characterized by hypotension,
hypoalbuminemia, edema and hemoconcentration. Episodes vary in
frequency and severity and may be life-threatening if treatment is
delayed. If symptoms develop, closely monitor and give standard
symptomatic treatment, which may include a need for intensive
care.
Potential for Tumor Growth Stimulatory Effects on Malignant
Cells
- The granulocyte colony-stimulating factor (G-CSF) receptor
through which ROLVEDON acts has been found on tumor cell lines. The
possibility that ROLVEDON acts as a growth factor for any tumor
type, including myeloid malignancies and myelodysplasia, diseases
for which ROLVEDON is not approved, cannot be excluded.
Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia
(AML) in Patients with Breast and Lung Cancer
- MDS and AML have been associated with the use of rhG-CSF
products in conjunction with chemotherapy and/or radiotherapy in
patients with breast and lung cancer. Monitor patients for signs
and symptoms of MDS/AML in these settings.
Aortitis
- Aortitis has been reported in patients receiving rhG-CSF
products. It may occur as early as the first week after start of
therapy. Consider aortitis in patients who develop generalized
signs and symptoms such as fever, abdominal pain, malaise, back
pain, and increased inflammatory markers (e.g., c-reactive protein
and white blood cell count) without known etiology. Discontinue
ROLVEDON if aortitis is suspected.
Nuclear Imaging
- Increased hematopoietic activity of the bone marrow in response
to growth factor therapy has been associated with transient
positive bone imaging changes. This should be considered when
interpreting bone imaging results.
Adverse Reactions
- The most common adverse reactions (≥20%) were fatigue, nausea,
diarrhea, bone pain, headache, pyrexia, anemia, rash, myalgia,
arthralgia, and back pain.
- Permanent discontinuation due to an adverse reaction occurred
in 4% of patients who received ROLVEDON. The adverse reaction
requiring permanent discontinuation in 3 patients who received
ROLVEDON was rash.
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/
Nora Brennan Chief Financial Officer 949.788.6700
InvestorRelations@sppirx.com
Lisa Wilson In-Site Communications, Inc. 212.452.2793
lwilson@insitecony.com
Grafico Azioni Spectrum Pharmaceuticals (NASDAQ:SPPI)
Storico
Da Mag 2024 a Giu 2024
Grafico Azioni Spectrum Pharmaceuticals (NASDAQ:SPPI)
Storico
Da Giu 2023 a Giu 2024