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Ardelyx Reports Third Quarter 2024 Financial Results and Provides Business Update

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Ardelyx (ARDX) reported strong Q3 2024 financial results, with IBSRELA generating $40.6 million in net product sales (15% quarter-over-quarter growth) and XPHOZAH achieving $51.5 million (39% quarter-over-quarter growth). Total revenue reached $98.2 million, compared to $56.4 million in Q3 2023. The company ended Q3 with $190.4 million in cash and investments. Ardelyx expects full-year 2024 IBSRELA net sales to be between $145-150 million. The company secured additional financing through an amended loan agreement with SLR Capital Partners, drawing $50 million with the option for an additional $50 million.

Ardelyx (ARDX) ha riportato risultati finanziari solidi per il terzo trimestre del 2024, con IBSRELA che ha generato 40,6 milioni di dollari di vendite nette di prodotto (crescita del 15% rispetto al trimestre precedente) e XPHOZAH che ha raggiunto 51,5 milioni di dollari (crescita del 39% rispetto al trimestre precedente). I ricavi totali sono stati di 98,2 milioni di dollari, rispetto ai 56,4 milioni di dollari del terzo trimestre del 2023. La società ha concluso il terzo trimestre con 190,4 milioni di dollari in contante e investimenti. Ardelyx prevede che le vendite nette di IBSRELA per l'intero anno 2024 siano comprese tra 145 e 150 milioni di dollari. La società ha ottenuto ulteriore finanziamento attraverso un accordo di prestito modificato con SLR Capital Partners, attingendo 50 milioni di dollari con l'opzione di ulteriori 50 milioni di dollari.

Ardelyx (ARDX) reportó sólidos resultados financieros en el tercer trimestre de 2024, con IBSRELA generando 40.6 millones de dólares en ventas netas de productos (un crecimiento del 15% en comparación con el trimestre anterior) y XPHOZAH alcanzando 51.5 millones de dólares (un crecimiento del 39% en comparación con el trimestre anterior). Los ingresos totales alcanzaron 98.2 millones de dólares, en comparación con 56.4 millones de dólares en el tercer trimestre de 2023. La empresa cerró el tercer trimestre con 190.4 millones de dólares en efectivo e inversiones. Ardelyx espera que las ventas netas de IBSRELA para todo el año 2024 sean de entre 145 y 150 millones de dólares. La compañía aseguró financiamiento adicional a través de un acuerdo de préstamo enmendado con SLR Capital Partners, retirando 50 millones de dólares con la opción de otros 50 millones.

Ardelyx (ARDX)는 2024년 3분기 강력한 재무 결과를 보고했으며, IBSRELA는 4060만 달러의 순 제품 판매를 기록했고(전분기 대비 15% 성장), XPHOZAH는 5150만 달러를 달성했습니다(전분기 대비 39% 성장). 총 수익은 9820만 달러에 달했으며, 2023년 3분기의 5640만 달러와 비교됩니다. 회사는 3분기를 1억 9040만 달러의 현금 및 투자 자산으로 마감했습니다. Ardelyx는 2024년 전체 IBSRELA 순 매출이 1억 4500만 달러에서 1억 5000만 달러 사이가 될 것으로 예상하고 있습니다. 회사는 SLR Capital Partners와 수정된 대출 계약을 통해 추가 자금을 확보했으며, 5000만 달러를 인출하고 추가 5000만 달러에 대한 옵션을 가지고 있습니다.

Ardelyx (ARDX) a annoncé de solides résultats financiers pour le troisième trimestre 2024, avec IBSRELA générant 40,6 millions de dollars de ventes nettes de produits (une croissance de 15 % par rapport au trimestre précédent) et XPHOZAH atteignant 51,5 millions de dollars (une croissance de 39 % par rapport au trimestre précédent). Le chiffre d'affaires total a atteint 98,2 millions de dollars, contre 56,4 millions de dollars au troisième trimestre 2023. L'entreprise a terminé le troisième trimestre avec 190,4 millions de dollars en liquidités et investissements. Ardelyx s'attend à ce que les ventes nettes d'IBSRELA pour l'année entière 2024 soient comprises entre 145 et 150 millions de dollars. La société a sécurisé un financement supplémentaire par le biais d'un amendement au contrat de prêt avec SLR Capital Partners, tirant 50 millions de dollars avec l'option de 50 millions de dollars supplémentaires.

Ardelyx (ARDX) hat starke Finanzberichte für das 3. Quartal 2024 veröffentlicht, wobei IBSRELA 40,6 Millionen Dollar an Nettoproduktverkäufen (15 % Wachstum im Vergleich zum Vorquartal) und XPHOZAH 51,5 Millionen Dollar (39 % Wachstum im Vergleich zum Vorquartal) erwirtschaftete. Der Gesamtumsatz erreichte 98,2 Millionen Dollar, verglichen mit 56,4 Millionen Dollar im 3. Quartal 2023. Das Unternehmen schloss das 3. Quartal mit 190,4 Millionen Dollar in Bar und Investitionen ab. Ardelyx erwartet, dass die Nettoumsätze von IBSRELA im gesamten Jahr 2024 zwischen 145 und 150 Millionen Dollar liegen werden. Das Unternehmen sicherte sich zusätzliche Finanzierungen durch eine geänderte Kreditvereinbarung mit SLR Capital Partners, wobei 50 Millionen Dollar abgerufen wurden und die Option besteht, weitere 50 Millionen Dollar abzurufen.

Positive
  • Strong revenue growth with total Q3 revenue of $98.2M, up from $56.4M in Q3 2023
  • IBSRELA sales grew 15% quarter-over-quarter to $40.6M
  • XPHOZAH sales increased 39% quarter-over-quarter to $51.5M
  • Healthy cash position of $190.4M as of Q3 2024
  • Secured additional $50M financing with option for another $50M
Negative
  • Net loss of $0.8M in Q3 2024 compared to net income of $6.6M in Q3 2023
  • SG&A expenses increased significantly to $65.0M from $32.7M year-over-year
  • R&D expenses increased to $15.3M from $8.6M year-over-year

Insights

Q3 2024 shows remarkable financial performance with $98.2M total revenue, driven by strong product sales growth. IBSRELA revenue reached $40.6M (15% QoQ growth) while XPHOZAH delivered $51.5M (39% QoQ growth). The company maintains a healthy balance sheet with $190.4M in cash and investments, further strengthened by a $50M loan draw at favorable terms. The minimal net loss of $0.8M despite increased operational expenses demonstrates effective cost management and scaling operations. Full-year IBSRELA guidance of $145-150M suggests continued momentum.

Both flagship products are showing strong market adoption, indicating effective clinical positioning. IBSRELA's growth reflects successful penetration in the IBS-C market, supported by positive patient experiences and expanding prescriber base. XPHOZAH's rapid uptake demonstrates significant unmet need in dialysis patients with hyperphosphatemia. The planned CMS reimbursement changes in 2025 pose a challenge, but management's proactive approach to maintain patient access suggests strategic preparedness. Multiple scientific presentations and publications strengthen the clinical evidence base, potentially supporting further market expansion.

IBSRELA generates $40.6 million in net product sales revenue; Company expects full year 2024 IBSRELA net sales revenue to be between $145 and $150 million

XPHOZAH generates $51.5 million in net product sales revenue

Company ends Q3 with approximately $190 million in cash, cash equivalents and investments

Conference call scheduled for 4:30 PM Eastern Time

WALTHAM, Mass., Oct. 31, 2024 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today reported financial results for the third quarter ended September 30, 2024 and provided a business update.

“The continued strong performance of Ardelyx reported during the third quarter demonstrates our ability to execute and deliver on our goals, to focus on serving the patient and to build towards the future,” said Mike Raab, president and chief executive officer of Ardelyx. “IBSRELA continues to deliver consistent quarter-over-quarter growth driven by strong fundamentals: an attractive safety and efficacy profile, expanding awareness among healthcare prescribers, a streamlined path to access and, importantly, positive experiences among treated patients. In addition, the unmet need among dialysis patients for another option to help achieve and maintain target phosphorus levels is clear, demonstrated by the continued strong demand and growth for XPHOZAH. We remain committed to ensuring that this well-tolerated, effective and differentiated medicine remains available to patients, despite CMS’ planned change in Medicare Part D reimbursement in early-January 2025, and we are confident that we have made decisions that will best support our efforts to protect patient access to XPHOZAH. Finally, we continue to thoughtfully strengthen our balance sheet, providing us with capital to invest as we look to expand our business.”

IBSRELA® (tenapanor) records $40.6 million in net product sales revenue in Q3 2024
U.S. net product sales revenue for IBSRELA during the third quarter of 2024 was $40.6 million, showing approximately 15% quarter-over-quarter growth compared to the second quarter of 2024, and significant growth compared to the $22.3 million in net product sales revenue the company reported during the third quarter of 2023. The strong Q3 2024 performance reflects the continued growing demand for IBSRELA, demonstrated by increases in new and refill prescriptions as well as growth in new and repeat writing healthcare providers.

Ardelyx currently expects full-year 2024 U.S. net product sales revenue for IBSRELA to be between $145.0 and $150.0 million.

XPHOZAH® (tenapanor) launch progresses, records $51.5 million net product sales revenue during Q3 2024
A strong XPHOZAH launch continues, with the company reporting $51.5 million in net product sales revenue during the third quarter of 2024, approximately 39% quarter-over-quarter growth compared to the second quarter of 2024. The Q3 2024 performance reinforces the significant unmet need among dialysis patients with hyperphosphatemia.

Other Corporate Developments

  • Today, the company announced that it amended its February 2022 loan agreement with investment affiliates managed by SLR Capital Partners (SLR). The company drew $50 million at SOFR plus 4.02% in October 2024, added the opportunity to draw an additional $50 million at the same interest rate, and extended the interest-only period for existing and new tranches funded under the instrument to July 1, 2028.
  • The company had a significant presence at the 2024 Annual Scientific Meeting for the American College of Gastroenterology (ACG 2024) in Philadelphia from October 25-30, 2024. The company presented two posters featuring data from the 2024 IBS in America supplemental survey, sponsored by the company in collaboration with Health Union, which was conducted to better understand the symptoms and impact of IBS-C on the overall health and quality of life among patients.
  • The company had a significant presence at the 2024 Annual American Society of Nephrology Kidney Week in San Diego from October 23-27, 2024. The company presented two posters covering additional data for XPHOZAH.
  • In October, the company announced the publication of a review article exploring the patient burden and therapeutic landscape of IBS-C in the U.S. in Clinical and Experimental Gastroenterology. The article is available online and can be found here.
  • In August, the company announced the appointment of experienced biopharma executive, Eric Foster, as Chief Commercial Officer.
  • In July, the company announced the publication of two plain language summaries from XPHOZAH clinical trials in Current Medical Research and Opinion.

Third Quarter 2024 Financial Results

  • Cash Position: As of September 30, 2024, the company had total cash, cash equivalents and short-term investments of $190.4 million, as compared to total cash, cash equivalents and short-term investments of $184.3 million as of December 31, 2023. In October, the company drew $49.7 million in net proceeds under its term loan with SLR Investment Corp.

  • Revenue: Total revenue for the quarter ended September 30, 2024 was $98.2 million, compared to $56.4 million in total revenue during the quarter ended September 30, 2023, driven by increases in net product sales.
    • IBSRELA U.S. net product sales revenue was $40.6 million, compared to $22.3 million during the same period of 2023.
    • XPHOZAH U.S. net product sales revenue was $51.5 million, with no comparable revenue during the same period of 2023.
    • Product supply revenue was $5.3 million, compared to $2.1 million during the same period of 2023.
    • Licensing revenue was $20 thousand, compared to $32 million during the same period of 2023 related to $30 million milestone and license agreement amendment payments from Kyowa Kirin following the approval of tenapanor for hyperphosphatemia in Japan, as well as a $2.0 million milestone payment from Fosun Pharma following the acceptance of the NDA for tenapanor for hyperphosphatemia in China.
    • Non-cash royalty revenue related to the sale of future royalties was $0.8 million, with no comparable revenue during the same period of 2023.

  • R&D Expenses: Research and development expenses were $15.3 million for the quarter ended September 30, 2024, compared to $8.6 million for the quarter ended September 30, 2023, primarily related to increased medical engagement with the scientific communities in the areas of gastroenterology and nephrology and pediatric clinical trials.

  • SG&A Expenses: Selling, general and administrative expenses were $65.0 million for the quarter ended September 30, 2024, an increase of $32.3 million compared to $32.7 million for the quarter ended September 30, 2023. The increase in selling, general and administrative expenses was related to increased costs associated with the ongoing commercialization of IBSRELA and XPHOZAH, primarily the expansion of the IBSRELA field-based team which was completed during the third quarter of 2024.

  • Net Loss: Net loss for the quarter ended September 30, 2024 was $0.8 million, or $(0.00) per share, compared to net income of $6.6 million, or $0.03 per share, for the quarter ended September 30, 2023. The $0.8 million net loss for the third quarter of 2024 included share-based compensation expense of $9.1 million and non-cash interest expense related to the sale of future royalties of $1.9 million.

Conference Call Details
The company will host a conference call today, October 31, 2024, at 4:30 PM ET to discuss today’s announcement. To participate in the conference call, please dial (877) 346-6112 (domestic) or (848) 280-6350 (international) and ask to be joined into the Ardelyx call. A webcast of the call can also be accessed by visiting the Investor page of the company's website, https://ir.ardelyx.com/ and will be available on the website for 30 days following the call.

IMPORTANT SAFETY INFORMATION (IBSRELA)

WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS 
  
IBSRELA is contraindicated in patients less than 6 years of age; in nonclinical studies in young juvenile rats administration of tenapanor caused deaths presumed to be due to dehydration. Avoid use of IBSRELA in patients 6 years to less than 12 years of age. The safety and effectiveness of IBSRELA have not been established in patients less than 18 years of age. 
  

CONTRAINDICATIONS

  • IBSRELA is contraindicated in patients less than 6 years of age due to the risk of serious dehydration.
  • IBSRELA is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.

WARNINGS AND PRECAUTIONS
Risk of Serious Dehydration in Pediatric Patients

  • IBSRELA is contraindicated in patients below 6 years of age. The safety and effectiveness of IBSRELA in patients less than 18 years of age have not been established. In young juvenile rats (less than 1 week old; approximate human age equivalent of less than 2 years of age), decreased body weight and deaths occurred, presumed to be due to dehydration, following oral administration of tenapanor. There are no data available in older juvenile rats (human age equivalent 2 years to less than 12 years).
  • Avoid the use of IBSRELA in patients 6 years to less than 12 years of age. Although there are no data in older juvenile rats, given the deaths in younger rats and the lack of clinical safety and efficacy data in pediatric patients, avoid the use of IBSRELA in patients 6 years to less than 12 years of age.

Diarrhea
Diarrhea was the most common adverse reaction in two randomized, double-blind, placebo-controlled trials of IBS-C. Severe diarrhea was reported in 2.5% of IBSRELA-treated patients. If severe diarrhea occurs, suspend dosing and rehydrate patient.

MOST COMMON ADVERSE REACTIONS
The most common adverse reactions in IBSRELA-treated patients (incidence ≥2% and greater than placebo) were: diarrhea (16% vs 4% placebo), abdominal distension (3% vs <1%), flatulence (3% vs 1%) and dizziness (2% vs <1%).

INDICATION
IBSRELA (tenapanor) is indicated for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adults.

Please see full Prescribing Information, including Boxed Warning, for additional risk information.

IMPORTANT SAFETY INFORMATION (XPHOZAH)

CONTRAINDICATIONS
XPHOZAH is contraindicated in:

  • Pediatric patients under 6 years of age
  • Patients with known or suspected mechanical gastrointestinal obstruction

WARNINGS AND PRECAUTIONS
Diarrhea
Patients may experience severe diarrhea. Treatment with XPHOZAH should be discontinued in patients who develop severe diarrhea.

MOST COMMON ADVERSE REACTIONS
Diarrhea, which occurred in 43-53% of patients, was the only adverse reaction reported in at least 5% of XPHOZAH-treated patients with CKD on dialysis across trials. The majority of diarrhea events in the XPHOZAH-treated patients were reported to be mild-to-moderate in severity and resolved over time, or with dose reduction. Diarrhea was typically reported soon after initiation but could occur at any time during treatment with XPHOZAH. Severe diarrhea was reported in 5% of XPHOZAH-treated patients in these trials.

INDICATION
XPHOZAH (tenapanor), 30 mg BID, is indicated to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy.

For additional safety information, please see full Prescribing Information.

About Ardelyx
Ardelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA® (tenapanor) and XPHOZAH® (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL® (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been submitted in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada. For more information, please visit https://ardelyx.com/ and connect with us on X (formerly known as Twitter)LinkedIn and Facebook.

Forward Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding Ardelyx, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor of the Private Securities Reform Act of 1995, including Ardelyx’s current expectation regarding opportunities for continued IBSRELA and XPHOZAH adoption; projected U.S. net product sales revenue for IBSRELA for full year 2024; the company’s ability to execute and deliver on its goals and expand its business; and the company’s ability to protect patient access to XPHOZAH. Such forward-looking statements involve substantial risks and uncertainties that could cause Ardelyx's future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, uncertainties associated with the development of, regulatory process for, and commercialization of drugs in the U.S. and internationally. Ardelyx undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ardelyx's business in general, please refer to Ardelyx's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on October 31, 2024, and its future current and periodic reports to be filed with the Securities and Exchange Commission.

Investor and Media Contacts:
Caitlin Lowie
clowie@ardelyx.com


Ardelyx, Inc.
Condensed Balance Sheets
(In thousands)
 
 September 30, 2024 December 31, 2023
 (Unaudited)  (1) 
Assets   
Cash and cash equivalents$47,429 $21,470 
Investments 142,973  162,829 
Accounts receivable 53,195  22,031 
Prepaid commercial manufacturing 16,663  18,925 
Prepaid commercial manufacturing, non-current   4,235 
Inventory, current 11,378  12,448 
Inventory, non-current 73,780  37,039 
Property and equipment, net 1,028  1,009 
Right-of-use assets 3,625  5,589 
Prepaid and other assets 17,792  12,004 
Total assets$367,863 $297,579 
    
Liabilities and stockholders' equity   
Accounts payable$15,824 $11,138 
Accrued compensation and benefits 11,541  12,597 
Current portion of operating lease liability 2,567  4,435 
Deferred revenue 20,042  15,826 
Accrued expenses and other liabilities 33,295  15,041 
Operating lease liability, net of current portion 1,218  1,725 
Long-term debt 100,707  49,822 
Deferred royalty obligation related to the sale of future royalties 24,372  20,179 
Stockholders' equity 158,297  166,816 
Total liabilities and stockholders' equity$367,863 $297,579 

(1) Derived from the audited financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023.


Ardelyx, Inc.
Condensed Statements of Operations
(Unaudited)
(In thousands, except share and per share amounts)
 
 Three Months Ended
September 30,
 Nine Months Ended
September 30,
  2024   2023   2024   2023 
Revenues:       
Product sales, net:       
IBSRELA$40,638  $22,285  $104,444  $51,949 
XPHOZAH 51,452      103,749    
Total product sales, net 92,090   22,285   208,193   51,949 
Product supply revenue 5,322   2,092   7,461   5,354 
Licensing revenue 20   32,014   56   32,790 
Non-cash royalty revenue related to the sale of future royalties 809      1,776    
Total revenues 98,241   56,391   217,486   90,093 
Cost of goods sold:       
Cost of product sales 1,715   644   4,133   1,508 
Other cost of revenue 14,013   7,048   28,159   11,210 
Total cost of goods sold 15,728   7,692   32,292   12,718 
Operating expenses:       
Research and development 15,310   8,637   38,651   26,012 
Selling, general and administrative 64,970   32,664   182,618   86,653 
Total operating expenses 80,280   41,301   221,269   112,665 
Income (loss) from operations 2,233   7,398   (36,075)  (35,290)
Interest expense (3,357)  (1,107)  (9,039)  (3,210)
Non-cash interest expense related to the sale of future royalties (1,924)  (922)  (5,202)  (2,859)
Other income, net 2,282   1,460   6,766   4,308 
Income (loss) before provision for income taxes (766)  6,829   (43,550)  (37,051)
Provision for income taxes 43   200   231   214 
Net income (loss)$(809) $6,629  $(43,781) $(37,265)
Net income (loss) per share of common stock - basic and diluted$(0.00) $0.03  $(0.19) $(0.17)
Shares used in computing net income (loss) per share - basic 235,911,399   222,782,229   234,516,305   214,976,555 
Shares used in computing net (loss) income per share - diluted 235,911,399   227,894,335   234,516,305   214,976,555 

FAQ

What was Ardelyx (ARDX) revenue in Q3 2024?

Ardelyx reported total revenue of $98.2 million in Q3 2024, with IBSRELA generating $40.6 million and XPHOZAH generating $51.5 million in net product sales.

What is Ardelyx's (ARDX) full-year 2024 revenue guidance for IBSRELA?

Ardelyx expects IBSRELA's full-year 2024 U.S. net product sales revenue to be between $145.0 and $150.0 million.

How much cash does Ardelyx (ARDX) have as of Q3 2024?

Ardelyx had total cash, cash equivalents and short-term investments of $190.4 million as of September 30, 2024.

Ardelyx, Inc.

NASDAQ:ARDX

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Biotechnology
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