-- Q1 2023 net sales of $15.6 million, an
increase of 54% compared to Q4 2022 --
-- Company to be acquired by Assertio Holdings,
Inc., delivering value to stakeholders in an all stock and
contingent value rights (CVR) transaction --
-- Transaction expected to close in Q3 2023
--
Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a commercial
stage biopharmaceutical company focused on novel and targeted
oncology therapies, announced today financial results for the
three-month period ended March 31, 2023, and provided a corporate
update.
First Quarter 2023 and Recent Business
Update
- Net sales for Q1 2023 totaled $15.6 million, an increase of 54%
compared to Q4 2022.
- 172 targeted accounts purchased ROLVEDON™ (eflapegrastim-xnst)
Injection during the quarter compared to 70 in Q4 2022, an increase
of 145%.
- Permanent J-Code for ROLVEDON went into effect on April 1,
facilitating more efficient and predictable reimbursement in the
outpatient setting.
- On April 25, announced acquisition by Assertio Holdings, Inc.
(Nasdaq: ASRT) (“Assertio”), a specialty pharmaceutical company
offering differentiated products to patients, in an all-stock and
CVR transaction which is expected to deliver immediate value to
stockholders while providing the opportunity to share in future
upside of ROLVEDON.
- Upfront consideration represents a premium of 65%, and the
total potential consideration a premium of 94% to Spectrum’s
closing price of $0.69 on April 24, 2023.
- Following an anticipated Q3 2023 closing, Assertio stockholders
will own approximately 65% of the combined company, and Spectrum
stockholders will own approximately 35% of the combined company, on
a fully diluted basis.
“Spectrum delivered a strong start to 2023 with outstanding
execution in the launch of ROLVEDON. This success is demonstrated
through significant quarter-over-quarter sales growth, account
expansion, and continued customer receptivity to ROLVEDON’s value
proposition,” said Tom Riga, President and Chief Executive Officer
of Spectrum Pharmaceuticals. “Following the acquisition, we believe
the combination of Spectrum’s commercial infrastructure and
Assertio’s digital non-personnel resources will set the brand up
for long-term success and accelerate the profitability of the
combined company.”
Financial Results for the Quarter Ended
March 31, 2023 (All numbers are from Continuing
Operations)
Net sales for the first quarter of 2023 were $15.6 million.
During the fourth quarter of 2022 we began to sell our sole
commercial product, ROLVEDON, which was approved by the FDA on
September 9, 2022. We had no sales during the first quarter of
2022.
Total cost of sales was $1.1 million for the quarter ended March
31, 2023, and consisted primarily of royalties associated with net
sales of ROLVEDON, stability testing and packaging costs. This
figure did not include any direct costs associated with the
manufacture of ROLVEDON, which were previously expensed as research
and development expense. As we sell through certain inventory that
was expensed prior to FDA approval of ROLVEDON, we expect the cost
of sales to remain low through the first nine months of 2023 and to
increase thereafter.
Selling, general and administrative expenses for the first
quarter of 2023 increased by $4.1 million to $14.0 million as
compared to the corresponding prior year period. The increase was
due primarily to increased sales and marketing expenses to support
the launch of ROLVEDON and an increase in legal and other fees
incurred in connection with the pending acquisition by
Assertio.
Research and development expenses increased for the three months
ended March 31, 2023 by $1.2 million to $5.4 million as compared to
the comparable period ended March 31, 2022. The current period had
decreased personnel expenses of $5.7 million related to the
reduction in workforce during the strategic restructuring that
began in January 2022 and decreased program activities of $5.0
million for poziotinib. These period over period decreases were
offset by the reversal of an $11.2 million ROLVEDON drug substance
accrual during the quarter ended March 31, 2022, which was a
concession provided by Hanmi for drug substance which had been
accrued during 2021 and is no longer payable.
Net loss from continuing operations was $5.0 million, or $0.02
per basic and diluted share, for the quarter ended March 31, 2023,
compared to a net loss of $15.4 million, or $0.09 per basic and
diluted share, for the comparable period in 2022.
The Company had a total cash, cash equivalents, and marketable
securities balance of approximately $56.1 million as of March 31,
2023.
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 similarly 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 treatment 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 is a commercial stage biopharmaceutical company, with a
strategy of acquiring, developing, and commercializing novel and
targeted oncology therapies. We have an in-house clinical
development organization with regulatory and data management
capabilities, in addition to commercial infrastructure and a field
based sales force for our marketed product, ROLVEDON™
(eflapegrastim-xnst) Injection. For additional information on
Spectrum please visit www.sppirx.com.
About Assertio
Assertio is a specialty pharmaceutical company offering
differentiated products to patients utilizing a non-personal
promotional model. We have built and continue to build our
commercial portfolio by identifying new opportunities within our
existing products as well as acquisitions or licensing of
additional approved products. To learn more about Assertio, visit
www.assertiotx.com.
Notice Regarding Forward-looking Statements
This communication contains “forward-looking statements” within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. Generally, the words “anticipate,” “estimate,” “expect,”
“project,” “intend,” “plan,” “contemplate,” “predict,” “forecast,”
“likely,” “believe,” “target,” “will,” “could,” “would,” “should,”
“potential,” “may” and similar expressions or their negative, may,
but are not necessary to, identify forward-looking statements. Such
forward-looking statements, including those regarding the timing,
and consummation and anticipated benefits of the transaction
described herein, involve risks and uncertainties. Assertio’s and
Spectrum’s experience and results may differ materially from the
experience and results anticipated in such statements. The accuracy
of such statements is subject to a number of risks, uncertainties
and assumptions including, but are not limited to, the following
factors: the risk that the conditions to the closing of the
transaction are not satisfied, including the risk that required
approvals of the transaction from the stockholders of Assertio or
stockholders of Spectrum or from regulators are not obtained;
litigation relating to the transaction; uncertainties as to the
timing of the consummation of the transaction and the ability of
each party to consummate the transaction; risks that the proposed
transaction disrupts the current plans or operations of Assertio or
Spectrum; the ability of Assertio and Spectrum to retain and hire
key personnel; competitive responses to the proposed transaction;
unexpected costs, charges or expenses resulting from the
transaction; potential adverse reactions or changes to
relationships with customers, suppliers, distributors and other
business partners resulting from the announcement or completion of
the transaction; the combined company’s ability to achieve the
synergies expected from the transaction, as well as delays,
challenges and expenses associated with integrating the combined
company’s existing businesses; 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 overall industry
and general economic conditions, including inflation, interest
rates and related monetary policy by governments in response to
inflation; geopolitical events, including the war between Russia
and Ukraine, and regulatory, economic and other risks associated
therewith; and continued uncertainty around the ongoing impacts of
the COVID-19 pandemic, as well as broader macroeconomic conditions.
Other factors that might cause such a difference include those
discussed in Assertio’s and Spectrum’s filings with the SEC, which
include their Annual Reports on Form 10-K, Quarterly Reports on
Form 10-Q and Current Reports on Form 8-K, and in the joint proxy
statement/prospectus on Form S-4 to be filed in connection with the
proposed transaction. For more information, see the section
entitled “Risk Factors” and the forward looking statements
disclosure contained in Assertio’s and Spectrum’s Annual Reports on
Form 10-K and in other filings. All forward-looking statements made
herein are based on information currently available to Spectrum as
of the date of this communication. Spectrum undertakes no
obligation to publicly update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise, except as required by law.
Additional Information and Where to Find It
In connection with the proposed transaction, Assertio intends to
file with the SEC a registration statement on Form S-4 that will
include a joint proxy statement of Spectrum and Assertio and that
also constitutes a prospectus of the Assertio. Each of Spectrum and
Assertio may also file other relevant documents with the SEC
regarding the proposed transaction. This document is not a
substitute for the joint proxy statement/prospectus or registration
statement or any other document that Spectrum or Assertio may file
with the SEC. The definitive joint proxy statement/prospectus (if
and when available) will be mailed to stockholders of Spectrum and
Assertio. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE
REGISTRATION STATEMENT, JOINT PROXY STATEMENT/PROSPECTUS AND ANY
OTHER RELEVANT DOCUMENTS THAT MAY BE FILED WITH THE SEC, AS WELL AS
ANY AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN
THEIR ENTIRETY IF AND WHEN THEY BECOME AVAILABLE BECAUSE THEY
CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED
TRANSACTION. Investors and security holders will be able to obtain
free copies of the registration statement and joint proxy
statement/prospectus (if and when available) and other documents
containing important information about Spectrum, Assertio and the
proposed transaction, once such documents are filed with the SEC
through the website maintained by the SEC at http://www.sec.gov.
Copies of the documents filed with the SEC by Assertio are also
available free of charge on Assertio’s internet website at
www.assertiotx.com or by contacting Assertio Investor Relations
Department through investor@assertiotx.com. Copies of the documents
filed with the SEC by Spectrum will be available free of charge
Spectrum’s internet website at www.sppirx.com or by contacting
Spectrum’s Investor Relations Department ir@sppirx.com.
Participants in the Solicitation
Spectrum and Assertio and their respective directors and
executive officers may be deemed to be participants in the
solicitation of proxies from their respective stockholders in
respect of the proposed transactions contemplated by the joint
proxy statement/prospectus. Information regarding the persons who
are, under the rules of the SEC, participants in the solicitation
of the stockholders of Spectrum and Assertio in connection with the
proposed transactions, including a description of their direct or
indirect interests, by security holdings or otherwise, will be set
forth in the joint proxy statement/prospectus when it is filed with
the SEC. Information regarding Spectrum’s directors and executive
officers, including a description of their direct and indirect
interests, by security holdings or otherwise, is available in its
Annual Report on Form 10-K for the year ended December 31, 2022 and
its Proxy Statement on Schedule 14A, dated April 27, 2022, which
are filed with the SEC. Information regarding Assertio’s directors
and executive officers, including a description of their direct and
indirect interests, by security holdings or otherwise, is available
in Assertio’s Annual Report on Form 10-K for the year ended
December 31, 2022 and its Proxy Statement on Schedule 14A, dated
April 3, 2023, which are filed with the SEC. Other information
regarding the participants in the proxy solicitations and a
description of their direct and indirect interests, by security
holdings or otherwise, will be contained in the joint proxy
statement/prospectus and other relevant materials to be filed with
the SEC regarding the proposed transaction when such materials
become available. Investors should read the joint proxy
statement/prospectus carefully when it becomes available before
making any voting or investment decisions. You may obtain free
copies of these documents from Spectrum or Assertio using the
sources indicated above.
No Offer or Solicitation
This communication is not intended to and shall not constitute
an offer to buy or sell or the solicitation of an offer to buy or
sell any securities, or a solicitation of any vote or approval, nor
shall there be any sale of securities in any jurisdiction in which
such offer, solicitation or sale would be unlawful prior to
registration or qualification under the securities laws of any such
jurisdiction. No offering of securities shall be made, except by
means of a prospectus meeting the requirements of Section 10 of the
U.S. Securities Act of 1933, as amended.
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.
SPECTRUM PHARMACEUTICALS,
INC.
Condensed Consolidated
Statements of Operations
(In thousands, except share and
per share amounts)
(Unaudited)
Three Months Ended
March 31,
2023
2022
Net sales
$
15,615
$
—
Expenses:
Cost of sales
1,063
—
Selling, general and administrative
13,998
9,870
Research and development
5,424
4,193
Total expenses
20,485
14,063
Loss from continuing operations before
other income (expense) and income taxes
(4,870
)
(14,063
)
Other income (expense):
Interest income
559
13
Interest expense
(943
)
(2
)
Other income (expense), net
248
(1,334
)
Total other expense
(136
)
(1,323
)
Loss from continuing operations before
income taxes
(5,006
)
(15,386
)
Provision for income taxes from continuing
operations
—
(16
)
Loss from continuing operations
(5,006
)
(15,402
)
Loss from discontinued operations, net of
income taxes
(1
)
(40
)
Net loss
$
(5,007
)
$
(15,442
)
Basic and diluted loss per share:
Loss from continuing operations
$
(0.02
)
$
(0.09
)
Loss from discontinued operations
$
—
$
—
Net loss, basic and diluted
$
(0.02
)
$
(0.09
)
Weighted average shares outstanding, basic
and diluted
201,918,066
169,735,019
SPECTRUM PHARMACEUTICALS,
INC.
Condensed Consolidated Balance
Sheets
(In thousands, except share and
par value amounts)
(Unaudited)
March 31, 2023
December 31,
2022
ASSETS
Current assets:
Cash and cash equivalents
$
52,373
$
40,368
Marketable securities
3,763
34,728
Accounts receivable, net
32,755
12,996
Other receivables
883
617
Inventories
12,862
9,230
Prepaid expenses and other current
assets
2,742
3,072
Total current assets
105,378
101,011
Property and equipment, net
534
476
Facility and equipment under lease
1,518
1,694
Other assets
245
157
Total assets
$
107,675
$
103,338
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities:
Accounts payable and other accrued
liabilities
$
35,379
$
38,105
Accrued payroll and benefits
3,502
4,580
Total current liabilities
38,881
42,685
Loan payable, long-term
28,840
28,666
Other long-term liabilities
13,149
4,099
Total liabilities
80,870
75,450
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; 205,284,506 and 202,827,831 issued
and outstanding at March 31, 2023 and December 31, 2022,
respectively
205
203
Additional paid-in capital
1,153,818
1,149,926
Accumulated other comprehensive loss
(2,887
)
(2,917
)
Accumulated deficit
(1,124,331
)
(1,119,324
)
Total stockholders’ equity
26,805
27,888
Total liabilities and stockholders’
equity
$
107,675
$
103,338
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230509005288/en/
Nora Brennan Chief Financial Officer 949.788.6700
InvestorRelations@sppirx.com
Lisa Wilson In-Site Communications, Inc. 212.452.2793
lwilson@insitecony.com
Spectrum Pharmaceuticals (NASDAQ:SPPI)
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