Spectrum Pharmaceuticals Reports First Quarter 2023 Financial Results and Corporate Update
-- Q1 2023 net sales of
-- Company to be acquired by
-- Transaction expected to close in Q3 2023 --
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 byAssertio 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 onApril 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
Financial Results for the Quarter Ended
Net sales for the first quarter of 2023 were
Total cost of sales was
Selling, general and administrative expenses for the first quarter of 2023 increased by
Research and development expenses increased for the three months ended
Net loss from continuing operations was
The Company had a total cash, cash equivalents, and marketable securities balance of approximately
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
- 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
About
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
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
Additional Information and Where to Find It
In connection with the proposed transaction,
Participants in the Solicitation
Spectrum and
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
Condensed Consolidated Statements of Operations (In thousands, except share and per share amounts) (Unaudited) |
|||||||
|
Three Months Ended
|
||||||
|
|
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 |
|
Condensed Consolidated Balance Sheets (In thousands, except share and par value amounts) (Unaudited) |
|||||||
|
|
|
|
||||
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, |
|
— |
|
|
|
— |
|
Common stock, |
|
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/
Chief Financial Officer
949.788.6700
InvestorRelations@sppirx.com
212.452.2793
lwilson@insitecony.com
Source: