Granisetron

NASHVILLE, Tenn. , May 6, 2025 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company, announced today that its product portfolio of FDA-approved brands delivered combined net revenues of $11.7 million during the first quarter of 2025, a 38% increase over the prior year period. As a result the Company generated a net profit of $1.3 million for the quarter, adjusted earnings of $2.4 million , and cash flow from operations of $3.9 million . Cumberland ended the quarter with approximately $70 million in total assets, $41.6 million in liabilities and $28.7 million of shareholders' equity. "We are entering an exciting time for our company, as we continue to build momentum and capitalize on a range of promising opportunities," said Cumberland Pharmaceuticals CEO A.J. Kazimi . "Our optimism is driven by strong performance from our approved brands, the expansion of international partnerships, meaningful progress across our clinical development programs and the potential for strategic acquisitions." RECENT COMPANY DEVELOPMENTS INCLUDE: Top-Line DMD Study Results In February 2025 , Cumberland announced positive top-line results from the Phase II study evaluating its ifetroban product candidate in patients with Duchenne muscular dystrophy (DMD). This marks a breakthrough for these patients, as it's the first successful Phase II study specifically targeting the cardiac complications of their condition. These study results were selected for a late-breaking presentation in March at the Muscular Dystrophy Association 's Clinical & Scientific Conference . That platform allowed Cumberland to share the promising results with the global DMD community, including leading researchers, clinicians and patient advocates who are working tirelessly to improve outcomes for those affected by this devastating disease. Next steps for Cumberland's DMD program include further data analysis and completion of a full study report in preparation for an end-of- Phase-II meeting with the FDA to determine the requirements for the product's approval. Vibativ® Approval in China Cumberland's potent antibiotic, Vibativ®, received approval from the regulatory authorities in China . This provides Cumberland access to the world's second-largest pharmaceutical market. The company expects the product to launch by the end of the year. FINANCIAL RESULTS: Net Revenue: For first quarter of 2025, net revenues were $11.7 million and included $3.5 million for Kristalose®, $2.3 million for Sancuso®, $1.4 million for Vibativ® and $1.3 million for Caldolor®. Operating Expenses: Total operating expenses for the quarter were $10.4 million . Net Income: The net income for the first quarter of 2025 was approximately $1.3 million . Adjusted Earnings: Adjusted earnings for the quarter were $2.4 million , or $0.16 per share. Balance Sheet: At March 31, 2025 , Cumberland had approximately $70 million in total assets, including $15.1 million in cash and cash equivalents. Liabilities totaled $41.6 million , including $5.2 million on the company's credit facility. Total shareholders' equity was $28.7 million on March 31, 2025 . EARNINGS REPORT CALL: A conference call will be held today, May 06, 2025 , at 4:30 p.m. Eastern Time to provide a company update and discuss the financial results. The link to register is: https://register-conf.media-server.com/register/BIea2bc7f82dd24caea135dbe5460d9b6f. Registered participants can dial in from their phone using a dial-in and PIN number that will be provided to them. Alternatively, they can choose a "Call Me" option to have the system automatically call them at the start of the conference. A replay of the call will be available for one year and can be accessed via Cumberland's website or by visiting: https://edge.media-server.com/mmc/p/wost2na9/. ABOUT CUMBERLAND PHARMACEUTICALS : Cumberland Pharmaceuticals Inc. is the largest biopharmaceutical company founded and headquartered in Tennessee and is focused on providing unique products that improve the quality of patient care. The company develops, acquires, and commercializes products for the hospital acute care, gastroenterology and oncology market segments. The company's portfolio of FDA-approved brands includes: Acetadote® (acetylcysteine) injection, for the treatment of acetaminophen poisoning; Caldolor® (ibuprofen) injection, for the treatment of pain and fever; Kristalose® (lactulose) oral, a prescription laxative, for the treatment of constipation; Sancuso® (granisetron) transdermal, for the prevention of nausea and vomiting in patients receiving certain types of chemotherapy treatment; Vaprisol® (conivaptan) injection, to raise serum sodium levels in hospitalized patients with euvolemic and hypervolemic hyponatremia; and Vibativ® (telavancin) injection, for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia, as well as complicated skin and skin structure infections. The company also has a series of Phase II clinical programs underway evaluating its ifetroban product candidate in patients with Duchenne Muscular Dystrophy, Systemic Sclerosis and Pulmonary Fibrosis. For more information on Cumberland's approved products, including full prescribing information, please visit the links to the individual product websites, which can be found on the company's website at www.cumberlandpharma.com. About Acetadote® (acetylcysteine) Injection Acetadote, administered intravenously within 8 to 10 hours after ingestion of a potentially hepatotoxic quantity of acetaminophen, is indicated to prevent or lessen hepatic injury. Used in the emergency department, Acetadote is approved in the United States to treat overdose of acetaminophen, a common ingredient in many over-the-counter medications. Acetadote is contraindicated in patients with hypersensitivity or previous anaphylactoid reactions to acetylcysteine or any components of the preparation. For full prescribing and safety information, visit www.acetadote.com. About Caldolor® (ibuprofen) Injection Caldolor is indicated in adults and pediatric patients for the management of mild to moderate pain and the management of moderate to severe pain as an adjunct to opioid analgesics, as well as the reduction of fever. It was the first FDA-approved intravenous therapy for fever. Caldolor is contraindicated in patients with known hypersensitivity to ibuprofen or other non-steroidal anti-inflammatory drugs (NSAIDs) as well as patients with a history of asthma or other allergic type reactions after taking aspirin or other NSAIDs. Caldolor is contraindicated for use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery. For full prescribing and safety information, including boxed warning, visit www.caldolor.com. About Kristalose® (lactulose) Oral Solution Kristalose is indicated for the treatment of acute and chronic constipation. It is a unique, proprietary, crystalline form of lactulose, with no restrictions on length of therapy or patient age. Kristalose is contraindicated in patients who require a low-galactose diet. Elderly, debilitated patients who receive lactulose for more than six months should have serum electrolytes (potassium, chloride, carbon dioxide) measured periodically. For full prescribing and safety information, visit www.kristalose.com. About Sancuso® (granisetron) Transdermal System Sancuso is the only skin patch approved by the FDA for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately and/or highly emetogenic chemotherapy. When applied 24 to 48 hours before receiving chemotherapy, the Sancuso patch slowly and continuously releases the medicine contained in the adhesive through clean and intact skin areas into the patient's bloodstream. It can prevent CINV for chemotherapy regimens of up to five consecutive days. For full prescribing and safety information, visit www.sancuso.com. About Vaprisol® (conivaptan hydrochloride) Injection Vaprisol is an intravenous treatment for hyponatremia used in the critical care setting. Hyponatremia is an electrolyte disturbance in which sodium ion concentration in blood plasma is lower than normal. This can be associated with a variety of critical care conditions including congestive heart failure, liver failure, kidney failure and pneumonia. The product is a vasopressin receptor antagonist that raises serum sodium levels and promotes free water secretion. Vaprisol is contraindicated in patients with hypovolemic hyponatremia. The coadministration of Vaprisol with potent CYP3A inhibitors, such as ketoconazole, itraconazole, clarithromycin, ritonavir and indinavir, is contraindicated. For full prescribing and safety information, including boxed warning, visit www.vaprisol.com. About Vibativ® (telavancin) for Injection Vibativ is a patented, FDA-approved injectable anti-infective for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia and complicated skin and skin structure infections. It addresses a range of Gram-positive bacterial pathogens, including those that are considered difficult-to-treat and multidrug-resistant. Intravenous unfractionated heparin sodium is contraindicated with Vibativ administration due to artificially prolonged activated partial thromboplastin time (aPTT) test results for up to 18 hours after Vibativ administration. Vibativ is contraindicated in patients with a known hypersensitivity to telavancin. For more information, please visit www.vibativ.com. ABOUT CUMBERLAND EMERGING TECHNOLOGIES: Cumberland Emerging Technologies, Inc. (www.cet-fund.com) is a joint initiative between Cumberland Pharmaceuticals Inc. , Vanderbilt University , LaunchTN and WinHealth. The mission of CET is to advance biomedical technologies and products conceived at Vanderbilt University and other regional research centers towards the marketplace. CET helps manage the development and commercialization process for select projects, and provides expertise on intellectual property, regulatory, manufacturing and marketing issues that are critical to successful new biomedical products. CET's Life Sciences Center provides laboratory space, equipment and infrastructure for CET's activities and other early-stage life sciences ventures. FORWARD LOOKING STATEMENTS: This press release contains forward-looking statements, which are subject to certain risks and reflect Cumberland's current views on future events based on what it believes are reasonable assumptions. No assurance can be given that these events will occur. Forward-looking statements include, among other things, statements regarding the Company's intent, belief or expectations, and can be identified by the use of terminology such as "may," "will," "expect," "believe," "intend," "plan," "estimate," "should," "seek," "anticipate," "look forward" and other comparable terms or the negative thereof. As with any business, all phases of Cumberland's operations are subject to factors outside of its control, and any one or combination of these factors could materially affect Cumberland's operation results. These factors include macroeconomic conditions, including rising interest rates and inflation, competition, an inability of manufacturers to produce Cumberland's products on a timely basis, failure of manufacturers to comply with regulations applicable to pharmaceutical manufacturers, natural disasters, public health epidemics, maintaining an effective sales and marketing infrastructure, and other events beyond the Company's control as more fully discussed in its most recent annual report on Form 10-K as filed with the U.S. Securities and Exchange Commission (" SEC "), as well as the Company's other filings with the SEC from time to time. There can be no assurance that results anticipated by the company will be realized or that they will have the expected effects. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date hereof. The Company does not undertake any obligation to publicly revise these statements to reflect events after the date hereof. CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIESCondensed Consolidated Balance Sheets(Unaudited) March 31, 2025 December 31, 2024 ASSETS Current assets: Cash and cash equivalents $ 15,108,413 $ 17,964,184 Accounts receivable, net 10,487,925 11,701,466 Inventories, net 4,098,859 3,999,995 Prepaid and other current assets 2,181,954 2,786,513 Total current assets 31,877,151 36,452,158 Non-current inventories 9,939,236 11,005,499 Property and equipment, net 298,740 277,365 Intangible assets, net 16,986,962 17,973,449 Goodwill 914,000 914,000 Operating lease right-of-use assets 7,177,490 6,176,923 Other assets 2,742,299 2,784,016 Total assets $ 69,935,878 $ 75,583,410 LIABILITIES AND EQUITY Current liabilities: Accounts payable $ 13,927,623 $ 13,914,266 Operating lease current liabilities 371,094 356,508 Current portion of revolving line of credit — 5,100,000 Other current liabilities 11,220,902 12,250,955 Total current liabilities 25,519,619 31,621,729 Revolving line of credit - long term 5,240,733 10,176,170 Operating lease non-current liabilities 4,829,054 4,939,739 Other long-term liabilities 6,005,853 6,299,795 Total liabilities 41,595,259 53,037,433 Equity: Shareholders' equity: Common stock—no par value; 100,000,000 shares authorized; 14,961,137and 13,952,624 shares issued and outstanding as of March 31, 2025 and December 31, 2024 , respectively 51,367,883 46,821,425 Accumulated deficit (22,710,863) (23,967,931) Total shareholders' equity 28,657,020 22,853,494 Noncontrolling interests (316,401) (307,517) Total equity 28,340,619 22,545,977 Total liabilities and equity $ 69,935,878 $ 75,583,410 CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIESCondensed Consolidated Statements of Operations(Unaudited) Three months ended March 31 , 2025 2024 Net revenues $ 11,713,055 $ 8,497,701 Costs and expenses: Cost of products sold 1,425,714 1,575,542 Selling and marketing 4,231,980 4,154,588 Research and development 1,295,076 1,158,253 General and administrative 2,463,008 2,367,907 Amortization 1,005,330 1,110,661 Total costs and expenses 10,421,108 10,366,951 Operating income (loss) 1,291,947 (1,869,250) Interest income 125,709 96,746 Interest expense (163,802) (118,526) Income (loss) before income taxes 1,253,854 (1,891,030) Income tax expense (5,670) (11,442) Net income (loss) 1,248,184 (1,902,472) Net loss (income) at subsidiary attributable to noncontrolling interests 8,884 (43,791) Net income (loss) attributable to common shareholders $ 1,257,068 $ (1,946,263) Earnings (loss) per share attributable to common shareholders - basic $ 0.08 $ (0.14) - diluted $ 0.08 $ (0.14) Weighted-average shares outstanding - basic 14,942,522 14,098,022 - diluted 15,259,824 14,098,022 CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIESCondensed Consolidated Statements of Cash Flows(Unaudited) Three months ended March 31 , 2025 2024 Cash flows from operating activities: Net income (loss) $ 1,248,184 $ (1,902,472) Adjustments to reconcile net loss to net cash provided by operating activities: Depreciation and amortization expense 1,031,584 1,150,685 Amortization of operating lease right-of-use assets 285,184 285,184 Share-based compensation 74,212 78,754 Increase (decrease) in non-cash contingent consideration 44,976 (230,430) Decrease (increase) in cash surrender value of life insurance policies overpremiums paid 81,182 (129,217) Noncash interest expense 5,362 3,810 Net changes in assets and liabilities affecting operating activities: Accounts receivable 1,213,541 (1,066,410) Inventories, net 967,399 170,469 Other current assets and other assets 60,371 205,619 Operating lease liabilities (219,493) (213,825) Accounts payable and other current liabilities (600,043) (645,542) Other long-term liabilities (293,942) 156,728 Net cash provided by (used in) operating activities 3,898,517 (2,136,647) Cash flows from investing activities: Additions to property and equipment (47,630) (41,621) Net investment in manufacturing facility (1,162,357) — Additions to intangible assets (18,199) (16,565) Net cash used in investing activities (1,228,186) (58,186) Cash flows from financing activities: Proceeds from ATM offering, net 5,266,334 — Borrowings on line of credit — 11,000,000 Payments on line of credit (10,035,437) (7,700,000) Cash settlement of contingent consideration (511,131) (630,701) Payments made in connection with repurchase of common shares (245,868) (247,605) Net cash provided by (used in) financing activities (5,526,102) 2,421,694 Net increase (decrease) in cash and cash equivalents (2,855,771) 226,861 Cash and cash equivalents at beginning of period $ 17,964,184 $ 18,321,624 Cash and cash equivalents at end of period $ 15,108,413 $ 18,548,485 CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIESReconciliation of Net Income (loss) Attributable to Common Shareholders to Adjusted Earnings (loss) andAdjusted Diluted Earnings (loss) Per Share(Unaudited) Three months ended March 31 , Three months ended March 31 , 2025 2025 2024 2024 Earningsimpact Earnings per share impact Earningsimpact Earnings pershare impact Net income (loss) attributable to commonshareholders $ 1,257,068 $ 0.08 $ (1,946,263) $ (0.14) Less: Net (income) loss at subsidiary attributable tononcontrolling interests 8,884 — (43,791) — Net income (loss) 1,248,184 0.08 (1,902,472) (0.13) Adjustments to net income (loss) Income tax expense 5,670 — 11,442 — Depreciation and amortization 1,031,584 0.07 1,150,685 0.08 Share-based compensation (a) 74,212 — 78,754 0.01 Interest income (125,709) (0.01) (96,746) (0.01) Interest expense 163,802 0.01 118,526 0.01 Adjusted earnings (loss) and adjusted diluted earnings (loss) per share $ 2,397,743 $ 0.16 $ (639,811) $ (0.05) Diluted weighted-average common shares outstanding: 15,259,824 14,098,022 The Company provided the above adjusted supplemental financial performance measures, which are considered "non-GAAP" financial measures under applicable SEC rules and regulations. These financial measures should be considered supplemental to, and not as a substitute for, financial information prepared in accordance with Generally Accepted Accounting Principles ("GAAP"). The definition of these supplemental measures may differ from similarly titled measures used by others. Because these supplemental financial measures exclude the effect of items that will increase or decrease the Company's reported results of operations, management encourages investors to review the Company's consolidated financial statements and publicly filed reports in their entirety. A reconciliation of the supplemental financial measures to the most directly comparable GAAP financial measures is included in the tables accompanying this release. Cumberland's management believes these supplemental financial performance measures are important as they are used by management, along with financial measures in accordance with GAAP, to evaluate the Company's operating performance. In addition, Cumberland believes that they will be used by certain investors to measure the Company's operating results. Management believes that presenting these supplemental measures provides useful information about the Company's underlying performance across reporting periods on a consistent basis by excluding items that Cumberland does not believe are indicative of its core business performance or reflect long-term strategic activities. Certain of these items are not settled through cash payments and include: depreciation, amortization, share-based compensation expense and income taxes. Cumberland utilizes its net operating loss carryforwards to pay minimal income taxes. In addition, the use of these financial measures provides greater transparency to investors of supplemental information used by management in its financial and operational decision-making, including the evaluation of the Company's operating performance. The Company defines these supplemental financial measures as follows: Adjusted Earnings (loss): net income (loss) adjusted for the impact of income taxes, depreciation and amortization expense, share-based compensation, interest income and interest expense. (a) Represents the share-based compensation of Cumberland. Adjusted Diluted Earnings (loss) Per Share: Adjusted Earnings (loss) divided by diluted weighted-average common shares outstanding. View original content to download multimedia:https://www.prnewswire.com/news-releases/cumberland-pharmaceuticals-reports-38-revenue-growth-in-q1-2025-302447518.html SOURCE Cumberland Pharmaceuticals Inc. Investor Contact: Shayla Simpson, Cumberland Pharmaceuticals Inc., (615) 255-0068; Media Contact: Molly Aggas, Dalton Agency, (704) 641-6641

Generated Q1 2025 Net Revenue of $38.9 million Delivered record Q1 2025 Adjusted EBITDA of $6.2 million Reached settlement with Mylan Pharmaceuticals, Inc. , regarding the parties' CINVANTI® and APONVIE® patent litigations, including an agreed market entry date of June 1, 2032 Adjusted EBITDA guidance raised to a range of $4 - $12M for full year 2025 CARY, N.C. , May 6, 2025 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX) ("Heron" or the "Company"), a commercial-stage biotechnology company, today announced financial results for the three months ended March 31, 2025 , and highlighted recent corporate updates. "We are off to a strong start in 2025, achieving record adjusted EBITDA for the first quarter. Building on our efforts to strengthen our financial foundation, we are well positioned for future growth, with strong tailwinds for our lead product, ZYNRELEF. These include the expanded label indications, the approval of the NOPAIN Act, the launch of the VAN, and the partnership with Crosslink Network, LLC ," said Craig Collard , Chief Executive Officer. Financial Guidance for 2025 Item 2025 Full-Year Guidance for Net Revenue and Adjusted EBITDA(in millions) Original Q1 Updated Guidance Net Revenue $153.0 to $163 .0 Adjusted EBITDA $0.0 to $8.0 $4.0 to $12 .0 Business Highlights Net Revenue growth of 12.2% Q1 2025 over Q1 2024, primarily driven by the acute care franchise which increased revenue by 89.4%; ZYNRELEF grew 60.4%. Settlement reached with Mylan Pharmaceuticals, Inc. ("Mylan"), wherein the Company has granted Mylan a license to market generic versions of CINVANTI and APONVIE in the United States beginning June 1, 2032 , or earlier under certain customary circumstances. Non-Opioid Policy for Pain Relief took effect April 1 , providing separate payment for non-opioids like ZYNRELEF by the Centers for Medicare & Medicaid Services with significant awareness among health care providers being recognized. Successful launch of the VAN for ZYNRELEF continues to progress, offering a more efficient aseptic preparation, streamlining operations within the surgical setting. Cash, cash equivalents, and short-term investments were $50.7 million as of March 31, 2025 . ZYNRELEF device transition for product preparation for use from the Vented Vial Spike ("VVS") to the Vial Access Needle ("VAN") proceeds smoothly with an orderly and efficient draw down of the VVS inventory. ZYNRELEF development of the ready to use Prefilled Syringe ("PFS") continues with a projected early 2027 launch. Net Revenue Performance - Quarter Ended March 31 2025 2024 Dollar Change Percentage Change Acute Care $10,302 $5,438 $4,864 89.4 % APONVIE $2,260 $425 $1,835 431.8 % ZYNRELEF $8,042 $5,013 $3,029 60.4 % Oncology $28,601 $29,232 ( $631 ) (2.2 %) CINVANTI $25,742 $25,617 $125 0.5 % SUSTOL $2,859 $3,615 ( $756 ) (20.9 %) Total Net Revenue $38,903 $34,670 $4,233 12.2 % Conference Call and Webcast Heron will host a conference call and live webcast on Tuesday, May 6, 2025 , at 8:00 a.m. ET . The conference call can be accessed by phone by utilizing the following registration link which will provide participants with dial-in details. To avoid delays, we encourage participants to dial into the conference call fifteen minutes ahead of the scheduled start time. The conference call will also be available via webcast under the Investor Relations section of Heron's website at www.herontx.com. An archive of the teleconference and webcast will also be made available on Heron's website for sixty days following the call. About ZYNRELEF® for Postoperative Pain ZYNRELEF is the first and only extended-release dual-acting local anesthetic that delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of nonsteroidal anti-inflammatory drug meloxicam. ZYNRELEF is the first and only extended-release local anesthetic to demonstrate 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. ZYNRELEF was initially approved by the FDA in May 2021 for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty. In December 2021 , the FDA approved an expansion of ZYNRELEF's indication to include foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures. On January 23, 2024 , the FDA approved ZYNRELEF for soft tissue and orthopedic surgical procedures including foot and ankle, and other procedures in which direct exposure to articular cartilage is avoided. Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures. Please see full prescribing information, including Boxed Warning, at www.ZYNRELEF.com. About APONVIE® for Prevention of Postoperative Nausea and Vomiting (PONV) Prevention APONVIE is a substance P/neurokinin 1 (NK1) Receptor Antagonist (RA), indicated for the prevention of post operative nausea and vomiting (PONV) in adults. Delivered via a 30-second IV push, APONVIE 32 mg was demonstrated to be bioequivalent to oral aprepitant 40 mg with rapid achievement of therapeutic drug levels. APONVIE is the same formulation as Heron's approved drug product CINVANTI. APONVIE is supplied in a single-dose vial that delivers the full 32 mg dose for PONV. APONVIE was approved by the FDA in September 2022 and became commercially available in the U.S. on March 6, 2023 . Please see full prescribing information at www.APONVIE.com. About CINVANTI® for Chemotherapy Induced Nausea and Vomiting (CINV) Prevention CINVANTI, in combination with other antiemetic agents, is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin as a single-dose regimen, delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) as a single-dose regimen, and nausea and vomiting associated with initial and repeat courses of MEC as a 3-day regimen. CINVANTI is an IV formulation of aprepitant, an NK1 RA. CINVANTI is the first IV formulation to directly deliver aprepitant, the active ingredient in EMEND® capsules. Aprepitant (including its prodrug, fosaprepitant) is a single-agent NK1 RA to significantly reduce nausea and vomiting in both the acute phase (0–24 hours after chemotherapy) and the delayed phase (24–120 hours after chemotherapy). The FDA-approved dosing administration included in the U.S. prescribing information for CINVANTI include 100 mg or 130 mg administered as a 30-minute IV infusion or a 2-minute IV injection. Please see full prescribing information at www.CINVANTI.com. About SUSTOL® for CINV Prevention SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. SUSTOL is an extended-release, injectable 5-hydroxytryptamine type 3 RA that utilizes Heron's Biochronomer® drug delivery technology to maintain therapeutic levels of granisetron for ≥5 days. The SUSTOL global Phase 3 development program was comprised of two, large, guideline-based clinical studies that evaluated SUSTOL's efficacy and safety in more than 2,000 patients with cancer. SUSTOL's efficacy in preventing nausea and vomiting was evaluated in both the acute phase (0–24 hours after chemotherapy) and delayed phase (24–120 hours after chemotherapy). Please see full prescribing information at www.SUSTOL.com. About Heron Therapeutics, Inc. Heron Therapeutics , Inc. is 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. For more information, visit www.herontx.com. Non-GAAP Financial Measures To supplement our financial results presented on a GAAP basis, we have included information about certain non-GAAP financial measures. We believe the presentation of these non-GAAP financial measures, when viewed with our results under GAAP, provide analysts, investors, lenders, and other third parties with insights into how we evaluate normal operational activities, including our ability to generate cash from operations, on a comparable year-over-year basis and manage our budgeting and forecasting. In our quarterly and annual reports, earnings press releases and conference calls, we may discuss the following financial measures that are not calculated in accordance with GAAP, to supplement our consolidated financial statements presented on a GAAP basis. Adjusted EBITDA Adjusted EBITDA is a non-GAAP financial measure that represents GAAP net income or loss adjusted to exclude interest expense, interest income, the benefit from or provision for income taxes, depreciation, amortization, stock-based compensation, and other adjustments to reflect changes that occur in our business but that we do not believe are indicative of ongoing operations. Adjusted EBITDA, as used by us, may be calculated differently from, and therefore may not be comparable to, similarly titled measures used by other companies. There are several limitations related to the use of adjusted EBITDA rather than net income or loss, which is the nearest GAAP equivalent, such as: adjusted EBITDA excludes depreciation and amortization and, although these are non-cash expenses, the assets being depreciated or amortized may have to be replaced in the future, the cash requirements for which are not reflected in adjusted EBITDA; we exclude stock-based compensation expense from adjusted EBITDA although: (i) it has been, and will continue to be for the foreseeable future, a significant recurring expense for our business and an important part of our compensation strategy; and (ii) if we did not pay out a portion of our compensation in the form of stock-based compensation, the cash salary expense included in operating expenses would be higher, which would affect our cash position; adjusted EBITDA does not reflect changes in, or cash requirements for, working capital needs; adjusted EBITDA does not reflect the benefit from or provision for income taxes or the cash requirements to pay taxes; and adjusted EBITDA does not reflect historical cash expenditures or future requirements for capital expenditures or contractual commitments Adjusted Operating Expenses Adjusted operating expenses is a non-GAAP financial measure that represents GAAP operating expenses adjusted to exclude stock-based compensation expense, depreciation and amortization, and other adjustments to reflect changes that occur in our business but do not represent ongoing operations. For more information on these non-GAAP financial measures, see the below table captioned "YTD Adjusted EBITDA." The Company has not provided a reconciliation of its guidance for adjusted EBITDA to the most directly comparable forward-looking GAAP measures, in reliance on the unreasonable efforts exception provided under Item 10(e)(1)(i)(B) of Regulation S-K, because the Company is unable to predict, without unreasonable efforts, the timing and amount of items that would be included in such a reconciliation, including, but not limited to, stock-based compensation expense, and inventory reserve and asset write-offs. These items are uncertain and depend on various factors that are outside of the Company's control or cannot be reasonably predicted. While the Company is unable to address the probable significance of these items, they could have a material impact on GAAP net income and operating expenses for the guidance period. Forward-looking Statements This news release contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. Heron cautions readers that forward-looking statements are based on management's expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially. Therefore, you should not place undue reliance on forward-looking statements. Examples of forward-looking statements include, among others, statements we make regarding the potential market opportunities for ZYNRELEF, APONVIE, CINVANTI and SUSTOL; revenue, adjusted EBITDA and other financial guidance provided by the Company; the potential additional market opportunity for the expanded U.S. label for ZYNRELEF or inclusion of ZYNRELEF under the OPPS and the ASC payment system or launch of the ZYNRELEF VAN; our ability to establish and maintain successful commercial arrangements like our co-promotion agreement with Crosslink Network, LLC ; the outcome of the Company's pending patent litigations, including potential appeals of any verdicts and the settlement described herein; whether the Company is required to write-off any additional inventory in the future; the expected future balances of Heron's cash, cash equivalents and short-term investments; the expected duration over which Heron's cash, cash equivalents and short-term investments balances will fund its operations and the risk that future equity financings may be needed; any inability or delay in achieving profitability, including as a result of regulatory developments and policy changes in the U.S. and other jurisdictions. Important factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, and in our other reports filed with the Securities and Exchange Commission , including under the caption "Risk Factors." Forward-looking statements reflect our analysis only on their stated date, and Heron takes no obligation to update or revise these statements except as may be required by law. Heron Therapeutics, Inc. Consolidated Statements of Operations (Unaudited) (In thousands, except per share amounts) Three Months Ended March 31 , 2025 2024 Revenues: Net product sales $ 38,903 $ 34,670 Cost of product sales 8,457 8,444 Gross profit 30,446 26,226 Operating expenses: Research and development 2,279 4,608 General and administrative 12,702 14,974 Sales and marketing 12,311 11,442 Total operating expenses 27,292 31,024 Income (loss) from operations 3,154 (4,798) Other (expense) income, net (519) 1,638 Net income (loss) 2,635 (3,160) Other comprehensive loss: Unrealized losses on short-term investments (12) (19) Comprehensive income (loss) $ 2,623 $ (3,179) Basic net income (loss) per share $ 0.02 $ (0.02) Diluted net income (loss) per share $ 0.01 $ (0.02) Weighted average common shares outstanding, basic 153,490 151,199 Weighted average common shares outstanding, diluted 196,921 151,199 Heron Therapeutics, Inc. Consolidated Balance Sheets (in thousands) March 31 , 2025 December 31 , 2024 (Unaudited) ASSETS Current assets: Cash and cash equivalents $ 19,269 $ 25,802 Short-term investments 31,410 33,481 Accounts receivable, net 78,736 78,881 Inventory, net 56,932 53,160 Prepaid expenses and other current assets 26,494 17,690 Total current assets 212,841 209,014 Property and equipment, net 14,537 14,863 Right-of-use lease assets 2,091 2,787 Other assets 6,283 6,483 Total assets $ 235,752 $ 233,147 LIABILITIES AND STOCKHOLDERS' DEFICIT Current liabilities: Accounts payable $ 12,333 $ 11,709 Accrued clinical and manufacturing liabilities 20,060 25,402 Accrued payroll and employee liabilities 6,451 9,554 Other accrued liabilities 47,423 41,755 Current lease liabilities 2,290 3,037 Total current liabilities 88,557 91,457 Non-current notes payable, net 25,213 25,026 Non-current convertible notes payable, net 149,753 149,700 Other non-current liabilities 682 615 Total liabilities 264,205 266,798 Stockholders' deficit: Common stock 1,524 1,521 Additional paid-in capital 1,886,981 1,884,409 Accumulated other comprehensive income 1 13 Accumulated deficit (1,916,959) (1,919,594) Total stockholders' deficit (28,453) (33,651) Total liabilities and stockholders' deficit $ 235,752 $ 233,147 Heron Therapeutics, Inc. U.S. GAAP to Non-GAAP Reconciliation Adjusted EBITDA (Unaudited) (in thousands) Three Months Ended March 31 , 2025 2024 Net Income (loss) $ 2,635 $ (3,160) Other expense (income), net 519 (1,638) Depreciation 551 689 Stock-based compensation 2,511 3,375 Adjusted EBITDA $ 6,216 $ (734) Investor Relations and Media Contact: Ira Duarte Executive Vice President, Chief Financial Officer Heron Therapeutics, Inc. iduarte@herontx.com858-251-4400 View original content to download multimedia:https://www.prnewswire.com/news-releases/heron-therapeutics-announces-first-quarter-2025-financial-results-and-highlights-recent-corporate-updates-302446762.html SOURCE Heron Therapeutics, Inc.