Heron Therapeutics Announces Third Quarter 2024 Financial Results and Narrows Financial Guidance
Heron Therapeutics reported positive YTD 2024 Adjusted EBITDA of $1.4 million and narrowed its financial guidance for Q4 2024. The company expects Q4 2024 Net Revenue between $37-43 million. Key developments include FDA approval of ZYNRELEF's Vial Access Needle in September and its inclusion in CMS Final Rule Non-Opioid Policy for Pain Relief. For Q3 2024, acute care franchise sales reached $7.4 million, while oncology care franchise reported $25.4 million. The company's cash position stood at $70.9 million as of September 30, 2024.
Heron Therapeutics ha riportato un EBITDA rettificato positivo di $1,4 milioni nel 2024 fino a oggi e ha ristretto le sue previsioni finanziarie per il Q4 2024. L'azienda prevede un fatturato netto per il Q4 2024 compreso tra $37-43 milioni. Tra i principali sviluppi si annoverano l'approvazione della FDA per l'ago di accesso al flaconcino di ZYNRELEF nel mese di settembre e la sua inclusione nella Politica per il sollievo dal dolore non oppioide della Regola Finale CMS. Per il Q3 2024, le vendite del franchising di assistenza acuta hanno raggiunto $7,4 milioni, mentre il franchising di assistenza oncologica ha riportato $25,4 milioni. La posizione di liquidità dell'azienda ammontava a $70,9 milioni al 30 settembre 2024.
Heron Therapeutics reportó un EBITDA ajustado positivo de $1.4 millones hasta la fecha en 2024 y estrechó su guía financiera para el cuarto trimestre de 2024. La compañía espera que los ingresos netos del Q4 2024 se encuentren entre $37-43 millones. Entre los desarrollos clave se incluye la aprobación de la FDA de la aguja de acceso al vial de ZYNRELEF en septiembre y su inclusión en la Política de No Opioides para el Alivio del Dolor de la Regla Final de CMS. Para el Q3 2024, las ventas de la franquicia de atención aguda alcanzaron $7.4 millones, mientras que la franquicia de atención oncológica reportó $25.4 millones. La posición de efectivo de la empresa era de $70.9 millones al 30 de septiembre de 2024.
헤론 테라퓨틱스는 2024년 기준으로 조정된 EBITDA가 140만 달러의 긍정적인 결과를 보고했으며, 2024년 4분기 재무 가이드를 축소했습니다. 이 회사는 2024년 4분기 순수익을 3,700만-4,300만 달러로 예상하고 있습니다. 주요 개발 사항으로는 9월에 ZYNRELEF의 바이알 접근 바늘에 대한 FDA 승인과 CMS 최종 규칙 비-opioid 통증 완화 정책에 대한 포함이 있습니다. 2024년 3분기 동안 급성 치료 프랜차이즈 판매는 740만 달러에 도달했고, 종양학 치료 프랜차이즈는 2,540만 달러를 보고했습니다. 2024년 9월 30일 기준으로 회사의 현금 보유액은 7,090만 달러였습니다.
Heron Therapeutics a rapporté un EBITDA ajusté positif de 1,4 million de dollars pour l'année 2024 jusqu'à présent et a affiné ses prévisions financières pour le quatrième trimestre 2024. L'entreprise s'attend à un chiffre d'affaires net pour le quatrième trimestre 2024 compris entre 37-43 millions de dollars. Parmi les développements clés, on note l'approbation par la FDA de l'aiguille d'accès au flacon de ZYNRELEF en septembre et son inclusion dans la politique de soulagement de la douleur non opioïde de la règle finale de la CMS. Pour le troisième trimestre 2024, les ventes de la franchise de soins aigus ont atteint 7,4 millions de dollars, tandis que celle des soins oncologiques a rapporté 25,4 millions de dollars. La position de liquidité de l'entreprise s'élevait à 70,9 millions de dollars au 30 septembre 2024.
Heron Therapeutics berichtete über ein positives bereinigtes EBITDA von 1,4 Millionen US-Dollar im Jahr 2024 bis heute und schränkte seine Finanzprognose für das vierte Quartal 2024 ein. Das Unternehmen erwartet für das vierte Quartal 2024 einen Nettoumsatz zwischen 37-43 Millionen US-Dollar. Zu den wichtigsten Entwicklungen gehört die FDA-Zulassung für die Access-Nadel des ZYNRELEF-Fläschchens im September sowie deren Einbeziehung in die CMS-Endregel-Politik zu nicht-opioiden Schmerzmitteln. Im dritten Quartal 2024 erreichten die Verkäufe der akuten Pflegefranchise 7,4 Millionen US-Dollar, während die Onkologie-Pflegefranchise 25,4 Millionen US-Dollar meldete. Die Liquiditätsposition des Unternehmens belief sich zum 30. September 2024 auf 70,9 Millionen US-Dollar.
- Achieved positive YTD 2024 Adjusted EBITDA of $1.4 million
- ZYNRELEF sales increased to $6.3 million in Q3 2024, up from $4.4 million in Q3 2023
- Acute care franchise sales grew to $7.4 million in Q3 2024, up from $4.7 million in Q3 2023
- APONVIE sales increased to $1.1 million in Q3 2024 from $0.3 million in Q3 2023
- Secured CMS separate payment status for ZYNRELEF until at least end of 2027
- Oncology care franchise sales declined to $25.4 million in Q3 2024 from $26.7 million in Q3 2023
- Cash position decreased to $70.9 million from $80.4 million at end of 2023
- CINVANTI sales decreased to $22.6 million in Q3 2024 from $23.3 million in Q3 2023
Insights
The Q3 results demonstrate significant operational improvements and financial stability. Key positives include positive YTD Adjusted EBITDA of
The acute care franchise shows strong growth with Net Product Sales up
Q4 revenue guidance of
The regulatory and commercial developments for ZYNRELEF are particularly significant. The CMS Final Rule inclusion validates the product's clinical value in reducing opioid use, while meeting strict efficacy criteria. This designation removes financial barriers to adoption and sets a precedent for private insurers.
The VAN approval addresses a key practical limitation by reducing preparation time to 20-45 seconds, which should improve workflow efficiency in surgical settings. Combined with the CrossLink partnership expansion and separate payment status, these developments position ZYNRELEF for accelerated market penetration in both hospital outpatient and ambulatory surgical centers.
- Reported positive YTD 2024 Adjusted EBITDA of
$1.4 million - Company expects Q4 2024 Net Revenue in the range of
$37 million $43 million - ZYNRELEF® (bupivacaine and meloxicam) extended-release solution Vial Access Needle ("VAN") approved in September and on track for Q4 2024 launch
- CMS Final Rule Non-Opioid Policy for Pain Relief includes ZYNRELEF as a qualifying product for separate payment in both the hospital outpatient department and ambulatory surgical center settings of care
"We are pleased to report that with our prudent financial management and continued revenue growth we were able to achieve positive Adjusted EBITDA for the quarter," said Craig Collard, Chief Executive Officer. "The future looks bright as we continue to grow all product revenue. The CrossLink partnership roll out, FDA approval of the VAN in September, and inclusion in the CMS Final Rule Non-Opioid Policy for Pain Relief, positions ZYNRELEF for significant growth within the surgical setting."
"We continue to deliver on our commitment to financial efficiency while growing revenue. The team has made great strides in the transformation of Heron over the past year. We are looking forward to a strong fourth quarter which is off to a great start. As such, we are narrowing guidance for full-year 2024."
Financial Guidance for 2024
The Company narrows its full-year 2024 guidance for Product Revenues, Net, Adjusted Operating Expenses and Adjusted EBITDA:
Original | Q2 Updated Guidance | Q3 Updated Guidance | |
Product Revenues, Net | |||
Adjusted Operating Expenses | |||
Adjusted EBITDA | |||
Business Highlights
- The ZYNRELEF VAN will be available for initial use in the fourth quarter following approval by the
U.S. Food and Drug Administration ("FDA") on September 24, 2024. The VAN will replace the current vented vial spike and has the potential to simplify aseptic preparation, while also significantly reducing ZYNRELEF's withdrawal time down to between twenty and forty-five seconds. - ZYNRELEF will continue to receive separate payment from April 1, 2025, until at least the end of 2027 as the result of inclusion in the "CMS OPPS and ASC Final Rule CY 2025 Non-Opioid Policy for Pain Relief" by the Centers for Medicare & Medicaid Services ("CMS"). The payment limitation for ZYNRELEF is set at
$2,267.26 - Cash and Cash Equivalents were
$70.9 million $80.4 million
Acute Care Franchise
- Acute Care Franchise Net Product Sales: For the three and nine months ended September 30, 2024, acute care franchise Net Product Sales were
$7.4 million $19.7 million $4.7 million $12.9 million - ZYNRELEF Net Product Sales: Net Product Sales of ZYNRELEF for the three and nine months ended September 30, 2024 were
$6.3 million $17.1 million $4.4 million $12.0 million - APONVIE® Net Product Sales: Net Product Sales of APONVIE for the three and nine months ended September 30, 2024 were
$1.1 million $2.6 million $0.3 million $0.9 million
Oncology Care Franchise
- Oncology Care Franchise Net Product Sales: For the three and nine months ended September 30, 2024, oncology care franchise Net Product Sales were
$25.4 million $83.8 million $26.7 million $79.9 million - CINVANTI® Net Product Sales: Net Product Sales of CINVANTI (aprepitant) injectable emulsion for the three and nine months ended September 30, 2024 were
$22.6 million $73.2 million $23.3 million $70.6 million - SUSTOL® Net Product Sales: Net Product Sales of SUSTOL (granisetron) extended-release injection for the three and nine months ended September 30, 2024 were
$2.8 million $10.6 million $3.4 million $9.3 million
Conference Call and Webcast
Heron will host a conference call and live webcast on Tuesday, November 12, 2024, 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 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 Postoperative Nausea and Vomiting (PONV)
APONVIE is a substance NK1 Receptor Antagonist (RA), indicated for the prevention of 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
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 do not represent 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;
- we exclude impairment of long-lived assets, the amount and/or frequency of which are not part of our underlying business.
- we exclude inventory write-downs (and write-ups should they occur), the amount and/or frequency of which are not part of our underlying business.
- 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;
- adjusted EBITDA does not reflect historical cash expenditures or future requirements for capital expenditures or contractual commitments; and
- we exclude restructuring expenses from adjusted EBITDA. Restructuring expenses primarily include employee severance and contract termination costs that are not related to acquisitions. The amount and/or frequency of these restructuring expenses are not part of our underlying business.
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.
The Company has not provided a reconciliation of its full-year 2024 guidance for adjusted EBITDA or adjusted operating expenses 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, acquisition related expense and litigation settlements. 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 results of the commercial launch of APONVIE; the potential additional market opportunity for the expanded
Heron Therapeutics, Inc. | ||||||||
Consolidated Statements of Operations | ||||||||
(In thousands, except per share amounts) | ||||||||
Three months ended | Nine months ended | |||||||
2024 | 2023 | 2024 | 2023 | |||||
Revenues: | (unaudited) | |||||||
Net product sales | ||||||||
Cost of product sales | 9,458 | 18,208 | 28,420 | 55,220 | ||||
Gross Profit | 23,352 | 13,226 | 75,084 | 37,591 | ||||
Operating expenses: | ||||||||
Research and development | 4,465 | 9,285 | 13,505 | 31,331 | ||||
General and administrative | 12,373 | 15,914 | 41,252 | 51,340 | ||||
Sales and marketing | 10,972 | 12,956 | 36,028 | 55,315 | ||||
Total operating expenses | 27,810 | 38,155 | 90,785 | 137,986 | ||||
Loss from operations | (4,458) | (24,929) | (15,701) | (100,395) | ||||
Other (expense) income, net | (390) | (79) | (1,542) | 560 | ||||
Net loss | ||||||||
Basic and diluted net loss per share | ||||||||
Weighted average common shares outstanding, basic and diluted | 152,830 | 144,990 | 152,213 | 133,747 | ||||
Heron Therapeutics, Inc. | |||
Consolidated Balance Sheets | |||
(in thousands) | |||
September 30, | December 31, | ||
(Unaudited) | |||
ASSETS | |||
Current assets: | |||
Cash and cash equivalents | |||
Short-term investments | 45,149 | 51,732 | |
Accounts receivable, net | 67,039 | 60,137 | |
Inventory | 45,950 | 42,110 | |
Prepaid expenses and other current assets | 11,308 | 6,118 | |
Total current assets | 195,187 | 188,774 | |
Property and equipment, net | 15,414 | 20,166 | |
Right-of-use lease assets | 3,469 | 5,438 | |
Other assets | 6,707 | 8,128 | |
Total assets | |||
LIABILITIES AND STOCKHOLDERS' DEFICIT | |||
Current liabilities: | |||
Accounts payable | |||
Accrued clinical and manufacturing liabilities | 22,859 | 22,291 | |
Accrued payroll and employee liabilities | 8,531 | 9,224 | |
Other accrued liabilities | 40,717 | 41,855 | |
Current lease liabilities | 3,249 | 3,075 | |
Total current liabilities | 85,544 | 79,685 | |
Non-current lease liabilities | 522 | 2,800 | |
Non-current notes payable, net | 24,828 | 24,263 | |
Non-current convertible notes payable, net | 149,647 | 149,490 | |
Other non-current liabilities | 241 | 241 | |
Total liabilities | 260,782 | 256,479 | |
Stockholders' deficit: | |||
Common stock | 1,517 | 1,503 | |
Additional paid-in capital | 1,881,695 | 1,870,525 | |
Accumulated other comprehensive (loss) income | 40 | 13 | |
Accumulated deficit | (1,923,257) | (1,906,014) | |
Total stockholders' deficit | (40,005) | (33,973) | |
Total liabilities and stockholders' deficit | |||
Investor Relations and Media Contact:
Ira Duarte
Executive Vice President, Chief Financial Officer
Heron Therapeutics, Inc.
iduarte@herontx.com
858-251-4400
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SOURCE Heron Therapeutics, Inc.
FAQ
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