Fosaprepitant Dimeglumine

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.