scPharmaceuticals Inc. Reports Second Quarter 2024 Financial Results and Provides Business Update
scPharmaceuticals Inc. (Nasdaq: SCPH) reported strong Q2 2024 financial results and business updates. Key highlights include:
- Net FUROSCIX revenue of $8.1 million, up 33% sequentially from Q1
- Approximately 9,300 FUROSCIX doses filled, a 15% increase from Q1
- Completed financings of up to $175 million, extending cash runway through expected profitability
- FDA approval to expand FUROSCIX indication for NYHA Class IV chronic heart failure patients
- Positive topline PK/PD data for FUROSCIX autoinjector
- FDA acceptance of sNDA for FUROSCIX label expansion to include CKD patients
The company's focus on commercial growth and lifecycle management initiatives positions FUROSCIX as a key part of a new heart failure treatment paradigm.
scPharmaceuticals Inc. (Nasdaq: SCPH) ha riportato risultati finanziari solidi per il secondo trimestre del 2024 e aggiornamenti aziendali. I principali punti salienti includono:
- Ricavi netti da FUROSCIX di 8,1 milioni di dollari, in aumento del 33% rispetto al primo trimestre
- Circa 9.300 dosi di FUROSCIX somministrate, un aumento del 15% rispetto al primo trimestre
- Completamenti di finanziamenti fino a 175 milioni di dollari, estendendo la liquidità fino alla redditività prevista
- Approvazione della FDA per espandere l'indicazione di FUROSCIX per pazienti con insufficienza cardiaca cronica di classe NYHA IV
- Dati positivi iniziali di PK/PD per l'autoiniettore FUROSCIX
- Accettazione da parte della FDA della sNDA per l'espansione dell'etichetta FUROSCIX per includere pazienti con CKD
Il focus dell'azienda sulla crescita commerciale e sulle iniziative di gestione del ciclo di vita posizione FUROSCIX come parte fondamentale di un nuovo paradigma di trattamento dell'insufficienza cardiaca.
scPharmaceuticals Inc. (Nasdaq: SCPH) reportó resultados financieros sólidos para el segundo trimestre de 2024 y actualizaciones empresariales. Los puntos destacados incluyen:
- Ingresos netos de FUROSCIX de 8.1 millones de dólares, un aumento del 33% en comparación con el primer trimestre
- Aproximadamente 9,300 dosis de FUROSCIX administradas, un incremento del 15% respecto al primer trimestre
- Finalización de financiamientos de hasta 175 millones de dólares, extendiendo la liquidez hasta la rentabilidad esperada
- Aprobación de la FDA para expandir la indicación de FUROSCIX para pacientes con insuficiencia cardíaca crónica de clase NYHA IV
- Datos positivos preliminares de PK/PD para el autoinyector FUROSCIX
- Aceptación de la FDA de la sNDA para la expansión de la etiqueta de FUROSCIX para incluir a pacientes con CKD
El enfoque de la empresa en el crecimiento comercial y las iniciativas de gestión del ciclo de vida posiciona a FUROSCIX como una parte clave de un nuevo paradigma en el tratamiento de la insuficiencia cardíaca.
scPharmaceuticals Inc. (Nasdaq: SCPH)는 2024년 2분기 재무 결과와 사업 업데이트를 보고했습니다. 주요 하이라이트는 다음과 같습니다:
- FUROSCIX의 순수익 $8.1 백만, 1분기 대비 33% 증가
- 약 9,300 FUROSCIX 용량이 채워졌으며, 1분기 대비 15% 증가
- 최대 $175 백만의 자금 조달 완료, 예상 수익성까지 현금 확보 연장
- NYHA Class IV 만성 심부전 환자를 위한 FUROSCIX의 적응증 확대에 대한 FDA 승인
- FUROSCIX 자가 주입기의 긍정적인 초기 PK/PD 데이터
- CKD 환자를 포함한 FUROSCIX 라벨 확장을 위한 sNDA의 FDA 수락
회사의 상업적 성장 및 생애주기 관리 이니셔티브에 대한 집중은 FUROSCIX를 새로운 심부전 치료 패러다임의 핵심으로 자리매김하게 합니다.
scPharmaceuticals Inc. (Nasdaq: SCPH) a annoncé de solides résultats financiers pour le deuxième trimestre de 2024 ainsi que des mises à jour sur ses activités. Les principaux points forts incluent :
- Revenu net de FUROSCIX de 8,1 millions de dollars, en hausse de 33 % par rapport au premier trimestre
- Environ 9 300 doses de FUROSCIX remplies, soit une augmentation de 15 % par rapport au premier trimestre
- Financements complétés jusqu'à 175 millions de dollars, prolongant la liquidité jusqu'à la rentabilité attendue
- Approbation de la FDA pour élargir l'indication de FUROSCIX pour les patients atteints d'insuffisance cardiaque chronique de classe NYHA IV
- Données préliminaires positives de PK/PD pour l'autoinjecteur FUROSCIX
- Acceptation par la FDA de la sNDA pour l'élargissement de l'étiquetage de FUROSCIX pour inclure les patients atteints de CKD
L'accent mis par l'entreprise sur la croissance commerciale et les initiatives de gestion du cycle de vie positionne FUROSCIX comme un élément clé d'un nouveau paradigme de traitement de l'insuffisance cardiaque.
scPharmaceuticals Inc. (Nasdaq: SCPH) hat starke Finanzzahlen für das zweite Quartal 2024 und Geschäftsupdates berichtet. Wichtige Höhepunkte sind:
- Netto-Umsatz von FUROSCIX in Höhe von 8,1 Millionen Dollar, ein Anstieg von 33 % im Vergleich zum ersten Quartal
- Etwa 9.300 FUROSCIX-Dosen gefüllt, ein Anstieg von 15 % gegenüber dem ersten Quartal
- Abgeschlossene Finanzierungen von bis zu 175 Millionen Dollar, die die Liquidität bis zur erwarteten Rentabilität verlängern
- FDA-Zulassung zur Erweiterung der FUROSCIX-Indikation für Patienten mit chronischer Herzinsuffizienz der NYHA-Klasse IV
- Positive vorläufige PK/PD-Daten für den FUROSCIX-Autoinjektor
- FDA-Akzeptanz des sNDA zur Erweiterung des FUROSCIX-Labels, um CKD-Patienten einzuschließen
Der Fokus des Unternehmens auf kommerzielles Wachstum und Initiativen zur Lebenszyklusverwaltung positioniert FUROSCIX als einen zentralen Bestandteil eines neuen Behandlungsschemas für Herzinsuffizienz.
- Net FUROSCIX revenue increased 33% sequentially to $8.1 million in Q2 2024
- FUROSCIX doses filled grew 15% sequentially to 9,300 in Q2 2024
- Unique prescribers of FUROSCIX increased 24% to 2,713 from Q1 to Q2 2024
- Gross-to-net discount improved from 19% in Q1 to 8% in Q2 2024
- Completed financings of up to $175 million, extending cash runway through expected profitability
- FDA approved FUROSCIX indication expansion for NYHA Class IV chronic heart failure patients
- Positive topline PK/PD data for FUROSCIX autoinjector achieved primary and secondary endpoints
- FDA accepted sNDA for FUROSCIX label expansion to include CKD patients
- Net loss increased to $17.1 million in Q2 2024 compared to $14.2 million in Q2 2023
- Cash, cash equivalents, and short-term investments decreased to $38.5 million from $76.0 million at the end of 2023
- Selling, general and administrative expenses increased to $17.5 million in Q2 2024 from $12.1 million in Q2 2023
Insights
scPharmaceuticals' Q2 2024 results show promising growth for FUROSCIX. Net revenue of
The company's recent
The FDA approval to expand FUROSCIX indication to NYHA Class IV chronic heart failure patients is a significant milestone. This opens up a new market segment for the most severe cases, potentially driving future revenue growth. The positive PK/PD data for the autoinjector and the FDA acceptance of the sNDA for chronic kidney disease (CKD) indication are also promising developments.
These regulatory advancements demonstrate FUROSCIX's potential to address unmet needs in heart failure and CKD management. The planned sNDA submission for the autoinjector by year-end could further enhance the product's appeal, potentially improving patient compliance and expanding its market reach.
The growth metrics for FUROSCIX are encouraging. The 24% increase in unique prescribers to 2,713 and the rise in doses per prescription to 6.3 indicate growing physician acceptance and patient adherence. The 15% sequential growth in filled doses to 9,300 suggests strong demand.
However, the company's plan for "measured investments" in commercial infrastructure might limit near-term growth potential. While this approach aligns with the goal of reaching profitability, it could potentially slow market penetration. The company needs to balance fiscal prudence with the need for aggressive market expansion, especially given the new indications and upcoming product improvements.
Generated 2Q 2024 net FUROSCIX® revenue of
Completed financing that extends our cash runway through expected profitability
Advanced multiple FUROSCIX growth initiatives including label expansion for heart failure, sNDA submission for CKD, and positive topline pivotal PK data for our Autoinjector
Company to host investor conference call and webcast today, Wednesday, August 14th, at 4:30pm ET
BURLINGTON, Mass., Aug. 14, 2024 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced financial results for the second quarter ended June 30, 2024, and provided a business update.
Business Update
- For the second quarter ended June 30, 2024, scPharmaceuticals reports:
- Net FUROSCIX revenue of
$8.1 million - Approximately 9,300 FUROSCIX doses filled, up
15% sequentially from approximately 8,100 in the first quarter of 2024 - 6.3 doses per prescription, up from 6.1 in the first quarter of 2024
- 2,713 unique prescribers of FUROSCIX from launch through end of the second quarter of 2024, up
24% from 2,183 from launch through the end of the first quarter of 2024 - Gross-to-net discount of
8% during the second quarter, as compared to19% in Q1 2024 - Inventory levels at specialty pharmacy partners remained consistent with March 31, 2024, levels
- Net FUROSCIX revenue of
- Completed financings of up to
$175 million , comprised of up to$75 million in senior debt and up to$50 million in a synthetic royalty, both with Perceptive Advisors, as well as approximately$50 million in equity led by leading life science investors. The Company used part of the proceeds from this new financing with Perceptive Advisors to repay$50 million of existing debt with Oaktree. - Announced FDA approval to expand the FUROSCIX indication to include patients with New York Heart Association Class IV chronic heart failure who represent the most symptomatic patients.
- Announced positive topline Pharmacokinetic/Pharmacodynamic (PK/PD) data demonstrating that the FUROSCIX autoinjector achieved primary pharmacokinetic and secondary pharmacodynamic endpoints. The Company is continuing to work towards its targeted submission of a Supplemental New Drug Application (sNDA) to the FDA by the end of the year.
- Announced that the FDA has accepted for filing the Company’s sNDA seeking to expand the FUROSCIX indication to include treatment of edema due to fluid overload in patients with chronic kidney disease (CKD). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of March 6, 2025.
“We continued to see growth during the second quarter, with net FUROSCIX revenue of
“We also achieved meaningful progress across our life cycle management and long-term growth initiatives for FUROSCIX that we previously announced. We received FDA approval to expand the FUROSCIX indication to include the sickest heart failure patients, including those classified as NYHA Class IV. We also announced positive PK/PD data from a study of our low volume autoinjector, and we are targeting to submit an sNDA by the end of this year. We also announced that the FDA has accepted our sNDA seeking to further expand the FUROSCIX label into chronic kidney disease. We plan to make measured investments in our commercial and sales infrastructure so that we are right sized to take maximum advantage of these opportunities.”
“Finally, earlier this week, we announced what we believe to be a transformational financing with leading healthcare-focused institutional investors which, based on our current operating plan, allows us to expand our commercial presence and extends our cash runway through profitability, a very significant milestone in our continued evolution,” Mr. Tucker concluded.
Second Quarter 2024 Financial Results and Financial Guidance
Product revenues were
Research and development expenses were
Selling, general and administrative expenses were
scPharmaceuticals reported a net loss of
scPharmaceuticals ended the second quarter of 2024 with
As of June 30, 2024, scPharmaceuticals’ total shares outstanding was 36,139,802.
Conference call and webcast information
scPharmaceuticals’ management will host a conference call and webcast to review the Company’s second quarter 2024 results today, Wednesday, August 14th, at 4:30 p.m. EDT. Participants should dial 1-877-407-9208 (domestic) or 1-201-493-6784 (international) with the conference code 13747259.
To access the Call me™ feature, which avoids having to wait for an operator, click here.
The live webcast and replay of the conference call can be accessed here or under “News & Events” in the Investor Relations section of the Company’s website, www.scpharmaceuticals.com.
FUROSCIX® (furosemide injection) 80 mg/10mL for subcutaneous use
FUROSCIX® is indicated for the treatment of congestion due to fluid overload in adult patients with chronic heart failure.
IMPORTANT SAFETY INFORMATION
FUROSCIX is contraindicated in patients with anuria, patients with a history of hypersensitivity to furosemide, any component of the FUROSCIX formulation or medical adhesives and in patients with hepatic cirrhosis.
Furosemide may cause fluid, electrolyte, and metabolic abnormalities, particularly in patients receiving higher doses, patients with inadequate oral electrolyte intake, and in elderly patients. Serum electrolytes, CO2, BUN, creatinine, glucose, and uric acid should be monitored frequently during furosemide therapy.
Excessive diuresis may cause dehydration and blood volume reduction with circulatory collapse and possibly vascular thrombosis and embolism, particularly in elderly patients.
Furosemide can cause dehydration and azotemia. If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, discontinue furosemide.
Cases of tinnitus and reversible or irreversible hearing impairment and deafness have been reported with furosemide. Reports usually indicate that furosemide ototoxicity is associated with rapid injection, severe renal impairment, the use of higher than recommended doses, hypoproteinemia or concomitant therapy with aminoglycoside antibiotics, ethacrynic acid, or other ototoxic drugs.
In patients with severe symptoms of urinary retention (because of bladder emptying disorders, prostatic hyperplasia, urethral narrowing), the administration of furosemide can cause acute urinary retention related to increased production and retention of urine. These patients require careful monitoring, especially during the initial stages of treatment.
Contact with water or other fluids and certain patient movements during treatment may cause the On-body Infusor to prematurely terminate infusion. Ensure patients can detect and respond to alarms.
The most common adverse reactions with FUROSCIX administration in clinical trials were site and skin reactions including erythema, bruising, edema, and injection site pain.
For more details, please read the full Prescribing Information at FUROSCIX.com/prescribing-information.pdf and Instructions for Use at FUROSCIX.com/instructions-for-use.pdf.
About scPharmaceuticals
scPharmaceuticals is a pharmaceutical company focused on developing and commercializing products that are designed to reduce healthcare costs and improve health outcomes. The Company develops, internally and through strategic partnerships, innovative products and solutions that aim to expand and advance the outpatient care of select acute conditions. The Company’s lead programs focus on the subcutaneous, self-administration of IV-strength treatments in heart failure and infectious disease. scPharmaceuticals is headquartered in Burlington, MA. For more information, please visit www.scPharmaceuticals.com.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding our ability to reach profitability and the timing thereof, the potential market impact and benefits of FUROSCIX and the success of the commercialization of FUROSCIX, the trial initiation, anticipated results, clinical design, potential regulatory submissions, approvals and timing thereof of the PK study, the expansion of the FUROSCIX indication to include NYHA Class IV heart failure patients, the expansion of the FUROSCIX indication to include treatment of edema in patients with chronic kidney disease, the clinical development and regulatory progress of SCP-111, including the results from the PK study and planned sNDA submission, and the timing thereof; the potential benefits of and the use of proceeds from the Perceptive and equity financings, and participation in upcoming events and presentations. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include but are not limited to, our dependence on the commercial success of FUROSCIX and, if approved, our other product candidates; risks related to the receipt of regulatory approval for our product candidates; risks related to our ability to manufacture, or the ability of third parties to deliver, sufficient product for commercialization of FUROSCIX or any of our product candidates, if approved; risks related to our history of operating losses, we have a history of significant operating losses and expect to incur significant and increasing losses for the foreseeable future; we may never achieve or maintain profitability; we may need additional funding and may be unable to raise capital when needed, which would force us to delay, reduce or eliminate our product development programs or commercialization efforts; the terms of our credit facility place restrictions on our operating and financial flexibility, and we may not have cash available to us in an amount sufficient to enable us to make interest or principal payments on our indebtedness when due; clinical and preclinical development involves a lengthy and expensive process with an uncertain outcome, and any difficulties or delays in the commencement or completion, or the termination or the potential for the results from any clinical trials to support submission of sNDAs or comparable regulatory applications; and the risk that global economic factors and uncertainties will impact the Company’s operations. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the sections entitled “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, on file with the Securities and Exchange Commission, available at the Securities and Exchange Commission’s website at www.sec.gov, as well as discussions of potential risks, uncertainties and other important factors in the Company’s subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information unless required by law.
Katherine Miranda
scPharmaceuticals Inc., 781-301-6869
kmiranda@scpharma.com
Investors:
PJ Kelleher
LifeSci Advisors, 617-430-7579
pkelleher@lifesciadvisors.com
| scPharmaceuticals Inc. | |||||||||||||||
| Unaudited Consolidated Statements of Operations | |||||||||||||||
| (in thousands, except share and per share data) | |||||||||||||||
| THREE MONTHS ENDED JUNE 30, | SIX MONTHS ENDED JUNE 30, | ||||||||||||||
| 2023 | 2024 | 2023 | 2024 | ||||||||||||
| Product revenues, net | $ | 1,638 | $ | 8,054 | $ | 3,701 | $ | 14,156 | |||||||
| Operating expenses: | |||||||||||||||
| Cost of product revenues | $ | 354 | $ | 2,300 | $ | 959 | $ | 4,085 | |||||||
| Research and development | 2,934 | 2,677 | 5,050 | 5,403 | |||||||||||
| Selling, general and administrative | 12,096 | 17,508 | 22,992 | 34,955 | |||||||||||
| Total operating expenses | 15,384 | 22,485 | 29,001 | 44,443 | |||||||||||
| Loss from operations | (13,746 | ) | (14,431 | ) | (25,300 | ) | (30,287 | ) | |||||||
| Other income (loss) | 239 | (1,189 | ) | 1,229 | 1,783 | ||||||||||
| Interest income | 1,363 | 664 | 2,678 | 1,541 | |||||||||||
| Interest expense | (2,010 | ) | (2,134 | ) | (3,971 | ) | (4,235 | ) | |||||||
| Net loss | $ | (14,154 | ) | $ | (17,090 | ) | $ | (25,364 | ) | $ | (31,198 | ) | |||
| Net loss per share, basic and diluted | $ | (0.36 | ) | $ | (0.44 | ) | $ | (0.66 | ) | $ | (0.80 | ) | |||
| Weighted—average common shares outstanding, basic and diluted | 38,692,624 | 38,984,745 | 38,249,255 | 38,968,438 | |||||||||||
| scPharmaceuticals Inc. | |||||||
| Unaudited Consolidated Balance Sheet Data | |||||||
| (in thousands) | DECEMBER 31, | JUNE 30, | |||||
| 2023 | 2024 | ||||||
| Cash, cash equivalents and investments | $ | 76,013 | $ | 38,504 | |||
| Working capital | 79,804 | 49,701 | |||||
| Total assets | 94,479 | 65,458 | |||||
| Term loan | 38,811 | 39,990 | |||||
| Accumulated deficit | (281,346 | ) | (312,544 | ) | |||
| Total stockholders’ equity | 37,218 | 9,250 | |||||
FAQ
What was scPharmaceuticals' (SCPH) net FUROSCIX revenue in Q2 2024?
How many FUROSCIX doses were filled in Q2 2024 for SCPH?
What financing did scPharmaceuticals (SCPH) complete in Q2 2024?
What new FDA approvals did SCPH receive for FUROSCIX in Q2 2024?
When is the PDUFA date for SCPH's sNDA to expand FUROSCIX indication for CKD patients?
