# EDGAR Filing Document

**Accession Number:** 0000831547
**File Stem:** 0001193125-23-030337
**Filing Date:** 2023-2
**Character Count:** 17177
**Document Hash:** 83315593060502bab9b795f253b9318a
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001193125-23-030337.hdr.sgml**: 20230209

**ACCESSION NUMBER**: 0001193125-23-030337

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20230208

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230209

**DATE AS OF CHANGE**: 20230209

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** SPECTRUM PHARMACEUTICALS INC
- **CENTRAL INDEX KEY:** 0000831547
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **IRS NUMBER:** 930979187
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-35006
- **FILM NUMBER:** 23607305

**BUSINESS ADDRESS:**
- **STREET 1:** 11500 S. EASTERN AVE., SUITE 240
- **CITY:** HENDERSON
- **STATE:** NV
- **ZIP:** 89052
- **BUSINESS PHONE:** 702-835-6300

**MAIL ADDRESS:**
- **STREET 1:** 11500 S. EASTERN AVE., SUITE 240
- **CITY:** HENDERSON
- **STATE:** NV
- **ZIP:** 89052

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** NEOTHERAPEUTICS INC
- **DATE OF NAME CHANGE:** 19960819

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** AMERICUS FUNDING CORP
- **DATE OF NAME CHANGE:** 19920703

?xml version="1.0" encoding="utf-8" ? 8-K

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### UNITED STATES

### SECURITIES AND EXCHANGE COMMISSION

#### WASHINGTON, D.C. 20549

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### FORM 8-K

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#### CURRENT REPORT

#### Pursuant to Section 13 OR 15(d)

#### of The Securities Exchange Act of 1934

#### Date of Report (Date of earliest event reported): February 8, 2023

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## SPECTRUM PHARMACEUTICALS, INC.

#### (Exact name of registrant as specified in its charter)

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---

| | | |
|:---|:---|:---|
| **Delaware** | **001-35006** | **93-0979187** |
| **(State or other jurisdiction**<br> **of incorporation)** | **(Commission**<br> **File Number)** | **(IRS Employer**<br> **Identification No.)** |

---

---

| | | |
|:---|:---|:---|
| **Pilot House-Lewis Wharf, 2 Atlantic Avenue** | **6th Floor&nbsp;&nbsp;&nbsp;&nbsp; Boston, MA** | **02110** |
| **(Address of principal executive offices)** |  | **(Zip Code)** |

---

#### Registrant's telephone number, including area code: (617) 586-3900

#### Not Applicable

#### (Former name or former address, if changed since last report.)

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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

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| | | |
|:---|:---|:---|
| **Title of each class** | **Trading<br>Symbol(s)** | **Name of each exchange<br>on which registered** |
| Common Stock, $0.001 par value | SPPI | The NASDAQ Global Select Market |

---

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

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| | |
|:---|:---|
| **Item 8.01** | **Other Events.**  |

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On February 8, 2023, Spectrum Pharmaceuticals, Inc. issued a press release announcing that a permanent J-code, J1449, has been issued for ROLVEDON (eflapegrastim-xnst) Injection by the U.S. Centers for Medicare & Medicaid Services effective as of April 1, 2023.

A copy of the press release is included as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

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| | |
|:---|:---|
| **Item 9.01** | **Financial Statements and Exhibits.**  |

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) Exhibits.

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| | |
|:---|:---|
| **Exhibit<br>Number** | **Description** |
| 99.1 | [Press Release, dated February 8, 2023.](d447282dex991.htm) |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |

---

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#### SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

---

| | | |
|:---|:---|:---|
|  | **SPECTRUM PHARMACEUTICALS, INC.** | **SPECTRUM PHARMACEUTICALS, INC.** |
| Date: February 9, 2023 | By: | /s/ Nora E. Brennan |
|  |  | Name: Nora E. Brennan |
|  |  | Title: Executive Vice President and Chief Financial Officer |

---

## Exhibit 99.1

**Exhibit 99.1**![LOGO](g447282dsp12x.jpg)

**Spectrum Pharmaceuticals Receives Permanent J-Code for ROLVEDON<sup>™</sup> (eflapegrastim-xnst) Injection (J1449) from U.S. Centers for Medicare & Medicaid Services** 

**Boston, MA, February 8**, **2023** – Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology announced today that a permanent J-code, J1449, has been issued for ROLVEDON (eflapegrastim-xnst) Injection by the U.S. Centers for Medicare & Medicaid Services (CMS) effective as of April 1, 2023.

"This is an important milestone in the ROLVEDON launch. A permanent J-code will enable a more efficient and predictable reimbursement in the outpatient setting. The combination of a permanent J-code on April 1, 2023 and ROLVEDON'S inclusion in the National Comprehensive Cancer Network<sup>®</sup> Supportive Care Guidelines (NCCN Guidelines) announced on December 6, 2022 are key elements in establishing brand awareness and building customer confidence in our novel product," said Tom Riga, President and Chief Executive Officer of Spectrum Pharmaceuticals.

J-codes are permanent reimbursement codes used by commercial insurance plans, Medicare, Medicare Advantage, and other government payers for Medicare Part B drugs like ROLVEDON that are administered by a physician. Claims submission and documentation are simplified with a permanent J-code, facilitating and streamlining the billing and reimbursement process.

The permanent J-code for ROLVEDON, J1449 (Injection, eflapegrastim-xnst, 0.1 mg), will take effect April 1, 2023. The permanent J-code is published online on the CMS website here.

**About ROLVEDON<sup>™</sup>** 

ROLVEDON<sup>™</sup> (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.

2 Atlantic Avenue, 6th Floor • Boston, Massachusetts 02110 • Tel: (617) 586-3900 • www.sppirx.com • NASDAQ: SPPI

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![LOGO](g447282dsp12x.jpg)

Please see the Important Safety Information below and the full prescribing information for ROLVEDON at <u>www.rolvedon.com</u>.

**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.

<u>Limitations of Use</u> 

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.

2 Atlantic Avenue, 6th Floor • Boston, Massachusetts 02110 • Tel: (617) 586-3900 • www.sppirx.com • NASDAQ: SPPI

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![LOGO](g447282dsp12x.jpg)

**Leukocytosis** 

• White blood cell (WBC) counts of 100 x 10<sup>9</sup>/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 10<sup>9</sup>/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** 

2 Atlantic Avenue, 6th Floor • Boston, Massachusetts 02110 • Tel: (617) 586-3900 • www.sppirx.com • NASDAQ: SPPI

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![LOGO](g447282dsp12x.jpg)

 **FDA at 1800FDA1088 or <u>www.fda.gov/medwatch</u>** 

**About Spectrum Pharmaceuticals, Inc.** 

Spectrum Pharmaceuticals, Inc. is a 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 <u>www.sppirx.com</u>.

***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 the future success of Spectrum's commercial launch of ROLVEDON, including the aggregate size of the LA-GCSF market and Spectrum's ability to generate future sales into the community oncology clinic segment, 340B and non-340B hospitals and other systems within the market, the ability of Spectrum's pricing strategy to deliver near- and long-term value to clinics it serves, Spectrum's ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, 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.* 

2 Atlantic Avenue, 6th Floor • Boston, Massachusetts 02110 • Tel: (617) 586-3900 • www.sppirx.com • NASDAQ: SPPI

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![LOGO](g447282dsp12x.jpg)

*SPECTRUM PHARMACEUTICALS, INC.<sup>®</sup> is a registered trademark of Spectrum Pharmaceuticals, Inc. and its affiliates. REDEFINING CANCER CARE<sup>™</sup> and ROLVEDON<sup>™</sup> are the Spectrum Pharmaceuticals' logos and trademarks owned by Spectrum Pharmaceuticals, Inc. Any other trademarks are the property of their respective owners.* 

*<sup>©</sup> 2023 Spectrum Pharmaceuticals, Inc. All Rights Reserved* 

**Contacts:** 

Tom Riga

Chief Executive Officer

949.788.6700 <u>InvestorRelations@sppirx.com</u> 

Lisa Wilson

In-Site Communications, Inc.

212.452.2793 <u>lwilson@insitecony.com</u> 

2 Atlantic Avenue, 6th Floor • Boston, Massachusetts 02110 • Tel: (617) 586-3900 • www.sppirx.com • NASDAQ: SPPI