SCLX

EX-99.1

2 sclx-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

FOR IMMEDIATE RELEASE

October 8, 2024

Scilex Holding Company Provides Certain Preliminary Unaudited Financial Results for the Quarter Ended September 30, 2024

• ZTlido net sales for the quarter ended September 30, 2024 were in the range of $11.0 million to $13.0 million, compared to $10.1 million for the same period last year, representing growth in the range of approximately 9% to 29%.

• Total product net sales for the quarter ended September 30, 2024 were in the range of $12.0 million to $14.0 million, compared to $10.1 million for the same period last year, representing growth in the range of approximately 19% to 39%.

PALO ALTO, CALIFORNIA – October 8, 2024 (GLOBE NEWSWIRE) - Scilex Holding Company (Nasdaq: SCLX, “Scilex” or the “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, today provided certain preliminary unaudited financial results for the quarter ended September 30, 2024.

The Company estimates that:

• ZTlido net sales for the quarter ended September 30, 2024 were in the range of $11.0 million to $13.0 million, compared to $10.1 million for the same period last year, representing growth in the range of approximately 9% to 29%.

• Total product net sales for the quarter ended September 30, 2024 were in the range of $12.0 million to $14.0 million, compared to $10.1 million for the same period last year, representing growth in the range of approximately 19% to 39%.

This preliminary financial data has been prepared by and is the responsibility of Scilex. Scilex has not fully completed its review of these preliminary financial results for the quarter ended September 30, 2024. Scilex’s independent auditor has not reviewed or audited these preliminary estimated financial results. Scilex’s actual results may differ materially from these preliminary financial results and may be outside the estimated ranges.

Page | 1

For more information on Scilex Holding Company, refer to www.scilexholding.com

For more information on Scilex Holding Company Sustainability Report, refer to www.scilexholding.com/investors/sustainability

For more information on ZTlido® including Full Prescribing Information, refer to www.ztlido.com.

For more information on ELYXYB®, including Full Prescribing Information, refer to www.elyxyb.com.

For more information on Gloperba®, including Full Prescribing Information, refer to www.gloperba.com.

About Scilex Holding Company

Scilex Holding Company is an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain. Scilex targets indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with acute and chronic pain and are dedicated to advancing and improving patient outcomes. Scilex’s commercial products include: (i) ZTlido® (lidocaine topical system) 1.8%, a prescription lidocaine topical product approved by the U.S. Food and Drug Administration (the “FDA”) for the relief of neuropathic pain associated with postherpetic neuralgia, which is a form of post-shingles nerve pain; (ii) ELYXYB®, a potential first-line treatment and the only FDA-approved, ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults; and (iii) Gloperba®, the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults.

In addition, Scilex has three product candidates: (i) SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (“SEMDEXATM” or “SP-102”), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, for which Scilex has completed a Phase 3 study and was granted Fast Track status from the FDA in 2017; (ii) SP-103 (lidocaine topical system) 5.4%, (“SP-103”), a next-generation, triple-strength formulation of ZTlido, for the treatment of chronic neck pain and for which Scilex has recently completed a Phase 2 trial in low back pain. SP-103 has been granted Fast Track status from the FDA in low back pain; and (iii) SP-104 (4.5 mg, low-dose naltrexone hydrochloride delayed-release capsules) (“SP-104”), a novel low-dose delayed-release naltrexone hydrochloride being developed for the treatment of fibromyalgia, for which Phase 1 trials were completed in the second quarter of 2022.

Scilex Holding Company is headquartered in Palo Alto, California.

Page | 2

Forward-Looking Statements

This press release and any statements made for and during any presentation or meeting concerning the matters discussed in this press release contain forward-looking statements related to Scilex and its subsidiaries under the safe harbor provisions of Section 21E of t

EX-99.1

2 sclx-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

FOR IMMEDIATE RELEASE

August 1, 2024

Scilex Holding Company Provides Certain Preliminary Unaudited Financial Results for the Month Ended July 31, 2024

• ZTlido net sales for the month ended July 31, 2024 were in the range of $4.0 million to $5.0 million, compared to $2.7 million for the same period last year, representing growth in the range of approximately 48% to 85%.

• Total product net sales for the month ended July 31, 2024 were in the range of $4.3 million to $5.3 million, compared to $2.8 million for the same period last year, representing growth in the range of approximately 54% to 89%.

PALO ALTO, CALIFORNIA – August 1, 2024 (GLOBE NEWSWIRE) - Scilex Holding Company (Nasdaq: SCLX, “Scilex” or the “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, today provided certain preliminary unaudited financial results for the month ended July 31, 2024. Scilex generates continuous sales growth in ZTlido® going into third quarter of 2024 with preliminary net sales for ZTlido® in the range of $4.0 million to $5.0 million.

The Company estimates that:

• ZTlido net sales for the month ended July 31, 2024 were in the range of $4.0 million to $5.0 million, compared to $2.7 million for the same period last year, representing growth in the range of approximately 48% to 85%.

• Total product net sales for the month ended July 31, 2024 were in the range of $4.3 million to $5.3 million, compared to $2.8 million for the same period last year, representing growth in the range of approximately 54% to 89%.

This preliminary financial data has been prepared by and is the responsibility of Scilex. Scilex has not fully completed its review of these preliminary financial results for the month ended July 31, 2024. Scilex’s independent auditor has not reviewed or audited these preliminary estimated financial results. Scilex’s actual results may differ materially from these preliminary financial results and may be outside the estimated ranges.

Page | 1

For more information on Scilex Holding Company, refer to www.scilexholding.com

For more information on Scilex Holding Company Sustainability Report, refer to www.scilexholding.com/investors/sustainability

For more information on ZTlido® including Full Prescribing Information, refer to www.ztlido.com.

For more information on ELYXYB®, including Full Prescribing Information, refer to www.elyxyb.com.

For more information on Gloperba®, including Full Prescribing Information, refer to www.gloperba.com.

About Scilex Holding Company

Scilex Holding Company is an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain. Scilex targets indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with acute and chronic pain and are dedicated to advancing and improving patient outcomes. Scilex’s commercial products include: (i) ZTlido® (lidocaine topical system) 1.8%, a prescription lidocaine topical product approved by the U.S. Food and Drug Administration (the “FDA”) for the relief of neuropathic pain associated with postherpetic neuralgia, which is a form of post-shingles nerve pain; (ii) ELYXYB®, a potential first-line treatment and the only FDA-approved, ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults; and (iii) Gloperba®, the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults.

In addition, Scilex has three product candidates: (i) SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (“SEMDEXATM” or “SP-102”), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, for which Scilex has completed a Phase 3 study and was granted Fast Track status from the FDA in 2017; (ii) SP-103 (lidocaine topical system) 5.4%, (“SP-103”), a next-generation, triple-strength formulation of ZTlido, for the treatment of chronic neck pain and for which Scilex has recently completed a Phase 2 trial in low back pain. SP-103 has been granted Fast Track status from the FDA in low back pain; and (iii) SP-104 (4.5 mg, low-dose naltrexone hydrochloride delayed-release capsules) (“SP-104”), a novel low-dose delayed-release naltrexone hydrochloride being developed for the treatment of fibromyalgia, for which Phase 1 trials were completed in the second quarter of 2022.

Scilex Holding Company is headquartered in Palo Alto, California.

Page | 2

Forward-Looking Statements

This press release and any statements made for and during any presentation or meeting concerning the matters discussed in this press release contain forward-l

EX-99.1

2 sclx-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

FOR IMMEDIATE RELEASE

July 1, 2024

Scilex Holding Company Provides Certain Preliminary Unaudited Financial Results for the Month Ended June 30, 2024 and Second Quarter of 2024

• ZTlido® net sales for the month of June 2024 grew in range of 70% to 104%, compared to the same period last year.

• ZTlido® net sales for the quarter ended June 2024 grew in range of 28% to 42%, compared to the same period last year.

• Total product net sales for the month of June 2024 grew in range of 77% to 116%, compared to the same period last year.

• Total product net sales for the quarter ended June 2024 grew in range of 30% to 44%, compared to the same period last year.

PALO ALTO, CALIFORNIA – July 1, 2024 (GLOBE NEWSWIRE) - Scilex Holding Company (Nasdaq: SCLX, “Scilex” or the “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, today provided certain preliminary unaudited financial results for the month ended June 30, 2024 and quarter ended June 30, 2024.

“For the month of June 2024, sales were highlighted by year-over-year growth trends improving in the second half of the second quarter and ZTlido® is surpassing in the month of June with the gross sales in the range of $22.0 million to $26.0 million mark for the first time,” said Jaisim Shah, Chief Executive Officer and President of Scilex. “In addition to ZTlido® expansion across all target market segments, we continue to expect improving sales trends throughout this year for ELYXYB® and our launch of Gloperba® as we broaden education and awareness around these complementary and standalone non-opioid solutions for managing acute pain.”

The Company estimates that:

• ZTlido net sales for the month ended June 30, 2024 were in the range of $7.5 million to $9.0 million, compared to $4.4 million for the same period last year, representing growth in the range of approximately 70% to 104%.

• ZTlido net sales for the quarter ended June 30, 2024 were in the range of $15.8 million to $17.5 million, compared to $12.3 million for the same period last year, representing growth in the range of approximately 28% to 42%.

Page | 1

• Total product net sales for the month ended June 30, 2024 were in the range of $7.8 million to $9.5 million, compared to $4.4 million for the same period last year, representing growth in the range of approximately 77% to 116%.

• Total product net sales for the quarter ended June 30, 2024 were in the range of $16.4 million to $18.2 million, compared to $12.6 million for the same period last year, representing growth in the range of approximately 30% to 44%.

• Cash and cash equivalents as of June 30, 2024 were in the range of $7.0 million to $10.0 million, compared to $34.1 million as of June 30, 2023.

• Accounts receivable as of June 30, 2024 were in the range of $38.0 million to $40.0 million, compared to $27.6 million as of June 30, 2023.

• Operating expenses for the quarter ended June 30, 2024 were in the range of $23.0 million to $26.0 million, compared to $31.2 million for the same period last year.

• Net loss for the quarter ended June 30, 2024 was in the range of $15.0 million to $20.0 million, compared to $26.6 million for the same period last year.

This preliminary financial data has been prepared by and is the responsibility of Scilex. Scilex has not fully completed its review of these preliminary financial results for the month and quarter ended June 30, 2024. Scilex’s independent auditor has not reviewed or audited these preliminary estimated financial results. Scilex’s actual results may differ materially from these preliminary financial results and may be outside the estimated ranges.

For more information on Scilex Holding Company, refer to www.scilexholding.com

For more information on ZTlido® including Full Prescribing Information, refer to www.ztlido.com.

For more information on ELYXYB®, including Full Prescribing Information, refer to www.elyxyb.com.

For more information on Gloperba®, including Full Prescribing Information, refer to www.gloperba.com.

About Scilex Holding Company

Scilex Holding Company is an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain. Scilex targets indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with acute and chronic pain and are dedicated to advancing and improving patient outcomes. Scilex’s commercial products include: (i) ZTlido® (lidocaine topical system) 1.8%, a prescription lidocaine topical product approved by the U.S. Food and Drug Administration (the “FDA”) for the relief of neuropathic pain associated with postherpetic neuralgia, which is a form of

Page | 2

post-shingles nerve pain; (ii) ELYXYB®, a pot