HERON THERAPEUTICS, INC. /DE/ Files 2023 Annual Report on Form 10-K

TL;DR

<b>Heron Therapeutics, Inc. filed its 2023 10-K report detailing its financial and operational status.</b>

AI Summary

HERON THERAPEUTICS, INC. /DE/ (HRTX) filed a Annual Report (10-K) with the SEC on March 12, 2024. Filed Form 10-K for the fiscal year ended December 31, 2023. Company was formerly known as AP PHARMA INC /DE/ and ADVANCED POLYMER SYSTEMS INC /DE/. Business address: 4242 CAMPUS POINT COURT, SUITE 200, SAN DIEGO, CA 92121. Business phone number: 8582514400. Incorporated in Delaware (DE).

Why It Matters

For investors and stakeholders tracking HERON THERAPEUTICS, INC. /DE/, this filing contains several important signals. This filing provides a comprehensive overview of Heron Therapeutics' performance and financial health for the fiscal year 2023, crucial for investors to assess the company's trajectory. As a 10-K filing, it contains audited financial statements and detailed risk factors, offering insights into potential challenges and the company's strategies to mitigate them.

Risk Assessment

Risk Level: medium — HERON THERAPEUTICS, INC. /DE/ shows moderate risk based on this filing. The company's financial health and future prospects are subject to the inherent risks of the pharmaceutical industry, including regulatory approvals, market competition, and product development success, as detailed in their 10-K filing.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to understand Heron Therapeutics' current financial position and future outlook.

Key Numbers

• 2023-12-31 — Fiscal Year End (Reported fiscal year end)
• 2024-03-12 — Filing Date (Date the 10-K was filed)
• 001-33221 — SEC File Number (SEC file number for the company)
• 2834 — SIC Code (Standard Industrial Classification code for Pharmaceutical Preparations)

Key Players & Entities

• HERON THERAPEUTICS, INC. /DE/ (company) — Filer name
• AP PHARMA INC /DE/ (company) — Former company name
• ADVANCED POLYMER SYSTEMS INC /DE/ (company) — Former company name
• 20231231 (date) — Fiscal year end
• 20240312 (date) — Filing date
• 4242 CAMPUS POINT COURT, SUITE 200 (address) — Business address
• SAN DIEGO (location) — Business address city
• 8582514400 (phone) — Business phone

FAQ

Industry Context

Heron Therapeutics operates in the pharmaceutical preparations industry, focusing on the development and commercialization of innovative therapies.

Regulatory Implications

As a pharmaceutical company, Heron Therapeutics is subject to stringent regulations from bodies like the FDA regarding drug development, manufacturing, and marketing.

What Investors Should Do

1. Review the financial statements for the fiscal year ended December 31, 2023.
2. Analyze the risk factors section for potential business challenges.
3. Examine any disclosures regarding executive compensation or significant business events.

Key Dates

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

Year-Over-Year Comparison

This is the initial 10-K filing for the fiscal year 2023, following previous filings which would have covered prior periods.

Key Financial Figures

• $0.01 — ch registered Common Stock, par value $0.01 per share HRTX The Nasdaq Capital M
• $1.16 — 5 million based on the closing price of $1.16 as reported by The Nasdaq Capital Marke

Filing Documents

• hrtx-20231231.htm (10-K) — 2391KB
• hrtx-ex23_1.htm (EX-23.1) — 5KB
• hrtx-ex31_1.htm (EX-31.1) — 15KB
• hrtx-ex31_2.htm (EX-31.2) — 15KB
• hrtx-ex32_1.htm (EX-32.1) — 9KB
• hrtx-ex97_1.htm (EX-97.1) — 14KB
• 0000950170-24-029951.txt (&nbsp;) — 10319KB
• hrtx-20231231.xsd (EX-101.SCH) — 1417KB
• hrtx-20231231_htm.xml (XML) — 1970KB

Business

Business 3 Item 1A.

Risk Factors

Risk Factors 19 Item 1B. Unresolved Staff Comments 58 Item 1C. Cybersecurity 58 Item 2.

Properties

Properties 58 Item 3.

Legal Proceedings

Legal Proceedings 59 Item 4. Mine Safety Disclosures 59 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 60 Item 6. [Reserved] 60 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 61 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 69 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 69 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 97 Item 9A.

Controls and Procedures

Controls and Procedures 97 Item 9B. Other Information 98 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 98 PART III Item 10. Directors, Executive Officers and Corporate Governance 99 Item 11.

Executive Compensation

Executive Compensation 99 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 99 Item 13. Certain Relationships and Related Transactions, and Director Independence 99 Item 14. Principal Accountant Fees and Services 99 PART IV Item 15. Exhibit and Financial Statement Schedules 100 Exhibit Index 101 Item 16. Form 10-K Summary 104

Signatures

Signatures 105

FORWARD-LOOKING STATEMENTS

FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K contains forward-looking statements within the meaning of the federal securities laws. 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. In some cases, you can identify forward-looking statements by the use of the words "believe," "expect," "anticipate," "intend," "estimate," "project," "will," "would," "could," "should," "may," "might," "plan," "assume" and other expressions that predict or indicate future events and trends and which do not relate to historical matters. All statements other than statements of historical facts contained in this Annual Report on Form 10-K, including statements regarding our future results of operations and financial position, business and commercialization strategy, products and product candidates, research pipeline, ongoing and planned preclinical studies and clinical trials, regulatory submissions and approvals, addressable patient population, research and development expenses, timing and likelihood of success, as well as plans and objectives of management for future operations, are forward-looking statements. You should not rely on forward-looking statements because they involve known and unknown risks, uncertainties and other factors, some of which are beyond our control. These risks, uncertainties and other factors may cause our actual results, performance or achievements to be materially different from our anticipated future results, performance or achievements expressed or implied by the forward-looking statements. Factors that might cause these differences include the following: our ability to successfully commercialize, market and achieve market acceptance of ZYNRELEF (bupivacaine and meloxicam) extended-release solution ("ZYNRELEF"), APONVIE (aprepitant) injectable emulsion ("APONVIE"), CINVANTI (aprepitant) injectable emulsion ("CINVANTI"),

BUSINESS

ITEM 1. BUSINESS. Overview We are a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care. Our advanced science, patented technologies, and innovative approach to drug discovery and development have allowed us to create and commercialize a portfolio of products that aim to advance the standard of care for acute care and oncology patients. Acute Care Product Portfolio ZYNRELEF ZYNRELEF was initially approved by the FDA in May 2021, and we commenced commercial sales in the U.S. in July 2021. In December 2021 and January 2024, the FDA approved an expansion of ZYNRELEF's indication. ZYNRELEF is approved for small-to-medium open abdominal, lower extremity total joint arthroplasty, soft tissue and orthopedic surgical procedures including foot and ankle, and other procedures in which direct exposure to articular cartilage is avoided. ZYNRELEF is a dual-acting local anesthetic that delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of the nonsteroidal anti-inflammatory drug meloxicam. ZYNRELEF is the first and only modified-release local anesthetic to be classified by the FDA as an extended-release product because ZYNRELEF demonstrated in Phase 3 studies significantly reduced pain and significantly increased proportion of patients requiring no opioids through the first 72 hours following surgery compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. In January 2024, we entered into a five-year distributor partnership with CrossLink Life Sciences, LLC ("Crosslink " ) to expand the sales network supporting ZYNRELEF. Crosslink will be the lead partner in the U.S. to expand ZYNRELEF promotion for orthopedic indications. The partnership will launch in several phases, initially at a regional level, followed by an expanded national rollout. In total, approximately 650