ARS Pharmaceuticals, Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>ARS Pharmaceuticals, Inc. (SPRY) has filed its 2023 annual report (10-K) detailing its financial performance and business operations for the fiscal year ending December 31, 2023.</b>

AI Summary

ARS Pharmaceuticals, Inc. (SPRY) filed a Annual Report (10-K) with the SEC on March 21, 2024. ARS Pharmaceuticals, Inc. (SPRY) filed its 2023 10-K report on March 21, 2024. The company's fiscal year ends on December 31st. ARS Pharmaceuticals was formerly known as Silverback Therapeutics, Inc., with a name change on April 12, 2016. The company is incorporated in Delaware and headquartered in San Diego, CA. The filing covers the period ending December 31, 2023.

Why It Matters

For investors and stakeholders tracking ARS Pharmaceuticals, Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of ARS Pharmaceuticals' financial health, operational activities, and strategic direction for the past fiscal year, which is crucial for investors to assess the company's performance and future prospects. Understanding the details within this filing, such as financial statements, risk factors, and executive compensation, is essential for investors to make informed decisions regarding their investment in SPRY.

Risk Assessment

Risk Level: medium — ARS Pharmaceuticals, Inc. shows moderate risk based on this filing. The company's financial statements and risk factors, which are detailed in the 10-K, will reveal its current financial standing and potential challenges, influencing its risk profile.

Analyst Insight

Investors should review the financial statements and risk factors sections of the 10-K to understand ARS Pharmaceuticals' financial health and potential challenges.

Key Numbers

• 2023-12-31 — Fiscal Year End (Conformed period of report)
• 2024-03-21 — Filing Date (Filed as of date)
• 10-K — Form Type (SEC filing type)
• 001-39756 — SEC File Number (SEC file number)

Key Players & Entities

• ARS Pharmaceuticals, Inc. (company) — Filer name
• SPRY (company) — Ticker symbol
• Silverback Therapeutics, Inc. (company) — Former company name
• San Diego, CA (company) — Business address city and state
• 2023-12-31 (date) — Conformed period of report
• 2024-03-21 (date) — Filed as of date

FAQ

Industry Context

ARS Pharmaceuticals operates in the pharmaceutical preparations industry, focusing on developing and commercializing novel therapeutic solutions.

Regulatory Implications

The company is subject to SEC regulations for public companies, including the requirement to file annual reports on Form 10-K.

What Investors Should Do

1. Review the financial statements within the 10-K for detailed revenue, expenses, and profitability figures.
2. Analyze the risk factors section to understand potential challenges and uncertainties facing ARS Pharmaceuticals.
3. Examine any disclosed executive compensation details to assess management incentives and remuneration.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K filing.
• 2024-03-21: Filing Date — Date the 10-K was officially filed with the SEC.

Year-Over-Year Comparison

This is the 2023 annual report filing, following previous filings which would include prior year financial data and operational updates.

Key Financial Figures

• $0.0001 — h registered Common Stock , par value $0.0001 per share SPRY The Nasdaq Stock Mar
• $6.70 — quarter) based on the closing price of $6.70 as reported on the Nasdaq Global Market
• $1 billion — in the United States was approximately $1 billion in 2023 among the approximately 3.2 mil

Filing Documents

• spry-20231231.htm (10-K) — 2694KB
• spry-ex10_9.htm (EX-10.9) — 22KB
• spry-ex21_1.htm (EX-21.1) — 12KB
• spry-ex23_1.htm (EX-23.1) — 13KB
• spry-ex31_1.htm (EX-31.1) — 14KB
• spry-ex31_2.htm (EX-31.2) — 14KB
• spry-ex32_1.htm (EX-32.1) — 18KB
• spry-ex97_1.htm (EX-97.1) — 53KB
• img76005383_0.jpg (GRAPHIC) — 87KB
• img76005383_1.jpg (GRAPHIC) — 379KB
• img76005383_2.jpg (GRAPHIC) — 372KB
• img76005383_3.jpg (GRAPHIC) — 46KB
• img76005383_4.jpg (GRAPHIC) — 114KB
• img76005383_5.jpg (GRAPHIC) — 142KB
• img76005383_6.jpg (GRAPHIC) — 24KB
• img76005383_7.jpg (GRAPHIC) — 100KB
• img76005383_8.jpg (GRAPHIC) — 97KB
• img76005383_9.jpg (GRAPHIC) — 125KB
• img76005383_10.jpg (GRAPHIC) — 128KB
• img76005383_11.jpg (GRAPHIC) — 130KB
• img76005383_12.jpg (GRAPHIC) — 191KB
• img76005383_13.jpg (GRAPHIC) — 20KB
• 0000950170-24-034689.txt (&nbsp;) — 13945KB
• spry-20231231.xsd (EX-101.SCH) — 1213KB
• spry-20231231_htm.xml (XML) — 1121KB

Business

Business 6 Item 1A.

Risk Factors

Risk Factors 46 Item 1B. Unresolved Staff Comments 101 Item 1C. Cybersecurity 101 Item 2.

Properties

Properties 102 Item 3.

Legal Proceedings

Legal Proceedings 102 Item 4. Mine Safety Disclosures 102 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 103 Item 6. [Reserved] 104 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 104 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 114 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 115 Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure 139 Item 9A.

Controls and Procedures

Controls and Procedures 139 Item 9B. Other Information 140 Item 9C. Disclosure regarding Foreign Jurisdictions that Prevent Inspections 140 PART III Item 10. Directors, Executive Officers and Corporate Governance 141 Item 11.

Executive Compensation

Executive Compensation 141 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 141 Item 13. Certain Relationships and Related Transactions, and Director Independence 141 Item 14. Principal Accountant Fees and Services 141 PART IV Item 15. Exhibits, Financial Statement Schedules 142 Item 16. Form 10-K Summary 144

SIGNATURES

SIGNATURES 2 PART I SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K (this "Annual Report") contains forward-looking statements that involve risks and uncertainties. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. All statements other than statements of historical facts contained in this Annual Report are forward-looking statements. In some cases, you can identify forward-looking statements by words such as "anticipate," "believe," "contemplate," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "seek," "should," "target," "will," "would," or the negative of these words or other comparable terminology. These forward-looking statements include, but are not limited to, statements about: any statements regarding future economic conditions or performance; research and development plans, including planned clinical trials, for neffy , including for additional indications; the expected timing for reporting data; the design and potential benefits of neffy ; our plans to complete a pharmacokinetic ("PK")/pharmacodynamic ("PD") study assessing repeat doses of neffy compared to repeat doses of an epinephrine injection product under allergen-induced rhinitis conditions to support approval of our New Drug Application ("NDA") resubmission for neffy with the U.S. Food and Drug Administration ("FDA") for the treatment of allergic reactions (Type I), including anaphylaxis for adults and children 30 kg; our expectations regarding the timing for resubmitting an NDA for neffy with the FDA for the treatment of allergic reactions (Type I), including anaphylaxis for adults and children 30 kg, the FDA's review of our NDA for neffy , including the classification of our NDA submission as Class 2 and the anticipated Prescription Drug User Fee Act ("PDUFA") target actio

Business

Item 1. Business. As used in this Annual Report, unless the context indicates or otherwise requires, "ARS," "ARS Pharma," the "company," "we," "us," "our," and other similar terms refer to ARS Pharmaceuticals, Inc., a Delaware corporation and its consolidated subsidiaries. neffy is a trademark of ours that we use in this Annual Report. This Annual Report also includes trademarks, trade names, and service marks that are the property of other organizations. Solely for convenience, our trademarks and trade names referred to in this Annual Report appear without the or symbols, but those references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights, or the right of the applicable licensor, to our trademark and trade names. The use or display of other companies' trade names or trademarks do not suggest or imply a relationship or affiliation with, or endorsement or sponsorship of us by, any other companies. Overview Company Summary We are a biopharmaceutical company focused on the development of our novel, potentially first-in-class product candidate, neffy (previously referred to as ARS-1) for the emergency treatment of Type I allergic reactions, including anaphylaxis. neffy is a proprietary composition of epinephrine with an innovative absorption enhancer called Intravail , which allows neffy to provide injection-like absorption of epinephrine at a low dose, in a small, easy-to-carry, easy-to-use, rapidly administered and reliable nasal spray. Type I severe allergic reactions are serious and potentially life-threatening events that can occur within minutes of exposure to an allergen and require immediate treatment with epinephrine injection, the only FDA-approved medication for these reactions. While epinephrine injection devices have been shown to be highly effective, there are well published limitations that result in many patients and caregivers delaying or not administering treatment i

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View this 10-K filing on SEC EDGAR