Spruce Biosciences Files 2023 Annual Report on Form 10-K

TL;DR

<b>Spruce Biosciences, Inc. has filed its annual 10-K report for the fiscal year ending December 31, 2023, detailing its business operations and financial standing.</b>

AI Summary

SPRUCE BIOSCIENCES, INC. (SPRB) filed a Annual Report (10-K) with the SEC on March 18, 2024. Spruce Biosciences, Inc. filed its 2023 Form 10-K on March 18, 2024. The filing covers the fiscal year ending December 31, 2023. The company's principal business is Pharmaceutical Preparations. Key agreements mentioned include the Kaken License Agreement and the Lilly License Agreement with Eli Lilly and Company. The company's business address is 611 Gateway Boulevard, Suite 740, South San Francisco, CA 94080.

Why It Matters

For investors and stakeholders tracking SPRUCE BIOSCIENCES, INC., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Spruce Biosciences' financial health, operational activities, and strategic partnerships for the fiscal year 2023, which is crucial for investors to assess the company's performance and future prospects. The report details significant agreements like the Kaken and Lilly License Agreements, indicating ongoing collaborations and potential revenue streams that are vital for the company's growth in the pharmaceutical sector.

Risk Assessment

Risk Level: medium — SPRUCE BIOSCIENCES, INC. shows moderate risk based on this filing. The company operates in the pharmaceutical industry, which is subject to significant regulatory hurdles, lengthy development cycles, and intense competition, posing inherent risks to its financial performance and market position.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to understand Spruce Biosciences' current financial position and the potential challenges it faces in bringing its products to market.

Key Numbers

• 2023-12-31 — Fiscal Year End (Conformed period of report)
• 2024-03-18 — Filing Date (Filed as of date)
• 001-39594 — SEC File Number (SEC file number for SPRB)
• 24759001 — Film Number (Film number for the filing)

Key Players & Entities

• SPRUCE BIOSCIENCES, INC. (company) — Filer name
• 20231231 (date) — Conformed period of report
• 20240318 (date) — Filed as of date
• 0001683553 (company) — Central Index Key
• 2834 (industry) — Standard Industrial Classification (Pharmaceutical Preparations)
• 611 GATEWAY BOULEVARD, SUITE 740 (address) — Business address street 1
• SOUTH SAN FRANCISCO (location) — Business address city
• CA (location) — Business address state

FAQ

Industry Context

Spruce Biosciences operates within the pharmaceutical preparations industry, focusing on the development and commercialization of therapies for rare diseases.

Regulatory Implications

As a pharmaceutical company, Spruce Biosciences is subject to extensive regulation by bodies like the FDA, governing drug development, approval, manufacturing, and marketing.

What Investors Should Do

1. Review the full 10-K filing for detailed financial statements and management discussion.
2. Analyze the risk factors section to understand potential challenges and uncertainties.
3. Investigate the company's licensing agreements and their potential impact on future revenue.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K filing.
• 2024-03-18: Filing Date — Date the 10-K was officially filed with the SEC.

Year-Over-Year Comparison

This is the initial 10-K filing for the fiscal year ending December 31, 2023, providing a baseline for future comparisons.

Key Financial Figures

• $0.0001 — ch registered Common Stock, par value $0.0001 per share SPRB Nasdaq Global Select
• $2.15 — k on the Nasdaq Global Select Market of $2.15 per share. The number of shares of Re
• $3.0 billion — h classic CAH is at least approximately $3.0 billion. We initiated CAHmelia-203, a placebo
• $15.0 million — , we will receive an upfront payment of $15.0 million from Kaken and will be eligible to rece

Filing Documents

• sprb-20231231.htm (10-K) — 2591KB
• sprb-ex23_1.htm (EX-23.1) — 5KB
• sprb-ex31_1.htm (EX-31.1) — 15KB
• sprb-ex31_2.htm (EX-31.2) — 15KB
• sprb-ex32_1.htm (EX-32.1) — 9KB
• sprb-ex32_2.htm (EX-32.2) — 9KB
• sprb-ex97.htm (EX-97) — 48KB
• img32413246_0.jpg (GRAPHIC) — 76KB
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• img32413246_24.jpg (GRAPHIC) — 38KB
• img32413246_25.jpg (GRAPHIC) — 17KB
• 0000950170-24-032819.txt (&nbsp;) — 10854KB
• sprb-20231231.xsd (EX-101.SCH) — 1323KB
• sprb-20231231_htm.xml (XML) — 1338KB

Business

Business 4 Item 1A.

Risk Factors

Risk Factors 41 Item 1B. Unresolved Staff Comments 98 Item 1C. Cybersecurity 98 Item 2.

Properties

Properties 99 Item 3.

Legal Proceedings

Legal Proceedings 99 Item 4. Mine Safety Disclosures 99 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 100 Item 6. [Reserved ] 101 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 102 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 115 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 116 Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure 141 Item 9A.

Controls and Procedures

Controls and Procedures 141 Item 9B. Other Information 142 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 142 PART III Item 10. Directors, Executive Officers and Corporate Governance 143 Item 11.

Executive Compensation

Executive Compensation 143 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 143 Item 13. Certain Relationships and Related Transactions, and Director Independence 143 Item 14. Principal Accountant Fees and Services 143 PART IV Item 15. Exhibit and Financial Statement Schedules 144 Item 16 Form 10-K Summary 146 ii Table of Contents SPECIAL NOTE REGARDING F ORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K (the "Annual Report") contains forward-looking statements within the meaning of the federal securities laws made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this Annual Report, including statements regarding our future results of operations and financial position, business strategy, research and development costs; the anticipated timing, costs and conduct of our clinical trials for our only product candidate, tildacerfont; the timing and likelihood of regulatory filings and approvals for tildacerfont; our ability to commercialize tildacerfont, if approved; the pricing and reimbursement of tildacerfont, if approved; the potential benefits of strategic collaborations and our ability to enter into strategic arrangements; the timing and likelihood of success, plans and objectives of management for future operations; future results of anticipated product development efforts; and our expected future financing needs, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "targe

Bus iness

Item 1. Bus iness. Overview We are a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for rare endocrine disorders with significant unmet medical need. We are initially developing our wholly-owned product candidate, tildacerfont, as the potential first non-steroidal therapy to offer markedly improved disease control and reduce steroid burden for patients suffering from classic congenital adrenal hyperplasia ("CAH"). Classic CAH is an autosomal recessive disease, driven by a mutation in the gene that encodes an enzyme necessary for the synthesis of key adrenal hormones with no known novel therapies approved in approximately 70 years. In classic CAH patients, the body is not able to produce cortisol, leading to serious health consequences. In the absence of cortisol, patients can face adrenal crisis and death rapidly as a result of any stressing event, such as infection. Physicians administer replacement steroid hormones to reduce the risk of adrenal crises and death; however, replacement alone is not sufficient to address all of the consequences associated with classic CAH. As a result, classic CAH patients suffer from premature puberty, impaired fertility, hirsutism, acne, the development of adrenal rest tumors, and an impaired quality of life, and additionally for females, virilized genitalia and menstrual irregularities. Currently, the only way to downregulate the production of excess androgens in classic CAH patients is to administer even higher doses of glucocorticoids, known as supraphysiologic glucocorticoid dosing. These elevated dose levels present specific side effects, including increased risks of developing diabetes, cardiovascular disease, stunted growth, osteoporosis, thin skin, gastrointestinal disorders, and decreased lifespan. Tildacerfont is a potent and highly selective, non-steroidal, oral antagonist of the CRF1 receptor, which is the receptor for corticotropin-releasing factor ("CRF"), a hormo

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View this 10-K filing on SEC EDGAR