UroGen Pharma Reports 2024 Third Quarter Financial Results and Business Highlights, Including the Potential Launch of UGN-102 in 2025
UroGen Pharma reported Q3 2024 financial results, highlighting FDA acceptance of UGN-102's New Drug Application with a PDUFA date of June 13, 2025. JELMYTO achieved net product sales of $25.2 million in Q3 2024, up from $20.9 million in Q3 2023. The company reported a net loss of $23.7 million ($0.55 per share) and maintained a strong cash position of $254.2 million. The Phase 3 ENVISION trial for UGN-102 showed a 79.6% complete response rate and 82.3% 12-month duration of response in treating low-grade intermediate-risk non-muscle invasive bladder cancer.
UroGen Pharma ha riportato i risultati finanziari del terzo trimestre 2024, evidenziando l'accettazione da parte della FDA della Domanda di Nuovo Farmaco per UGN-102, con una data PDUFA fissata per il 13 giugno 2025. JELMYTO ha raggiunto vendite nette di prodotto di 25,2 milioni di dollari nel terzo trimestre 2024, rispetto ai 20,9 milioni di dollari nel terzo trimestre 2023. L'azienda ha registrato una perdita netta di 23,7 milioni di dollari (0,55 dollari per azione) e ha mantenuto una solida posizione di liquidità di 254,2 milioni di dollari. Lo studio di Fase 3 ENVISION per UGN-102 ha mostrato un tasso di risposta completa del 79,6% e una durata di risposta di 12 mesi dell'82,3% nel trattamento del cancro alla vescica non muscolari invasivo a basso grado e rischio intermedio.
UroGen Pharma reportó los resultados financieros del tercer trimestre de 2024, destacando la aceptación por parte de la FDA de la Solicitud de Nuevo Medicamento de UGN-102, con una fecha PDUFA estipulada para el 13 de junio de 2025. JELMYTO logró ventas netas de productos por 25,2 millones de dólares en el tercer trimestre de 2024, un incremento respecto a los 20,9 millones de dólares en el tercer trimestre de 2023. La compañía reportó una pérdida neta de 23,7 millones de dólares (0,55 dólares por acción) y mantuvo una sólida posición de efectivo de 254,2 millones de dólares. El ensayo de Fase 3 ENVISION para UGN-102 mostró una tasa de respuesta completa del 79,6% y una duración de respuesta de 12 meses del 82,3% en el tratamiento del cáncer de vejiga no muscular invasivo de bajo grado y riesgo intermedio.
UroGen Pharma는 2024년 3분기 재무 결과를 보고하며, UGN-102의 새로운 의약품 신청이 FDA에 의해 수락되었고, PDUFA 날짜가 2025년 6월 13일로 설정되었음을 강조했습니다. JELMYTO는 2024년 3분기에 제품 순판매액으로 2520만 달러를 달성했으며, 이는 2023년 3분기에 비해 2090만 달러에서 증가한 수치입니다. 이 회사는 2370만 달러의 순손실(주당 0.55달러)을 보고했으며, 2억 5420만 달러의 강력한 현금 보유액을 유지하고 있습니다. UGN-102에 대한 3상 ENVISION 시험은 저급 중간위험 비근육 침습성 방광암 치료에서 79.6%의 완전 반응률과 82.3%의 12개월 반응 지속 시간을 보였습니다.
UroGen Pharma a publié les résultats financiers du troisième trimestre 2024, mettant en avant l'acceptation par la FDA de la demande de nouveau médicament pour UGN-102, avec une date PDUFA fixée au 13 juin 2025. JELMYTO a réalisé des ventes nettes de produits de 25,2 millions de dollars au troisième trimestre 2024, en hausse par rapport à 20,9 millions de dollars au troisième trimestre 2023. La société a enregistré une perte nette de 23,7 millions de dollars (0,55 dollar par action) et a maintenu une solide position de liquidités de 254,2 millions de dollars. L'essai de Phase 3 ENVISION pour UGN-102 a montré un taux de réponse complet de 79,6 % et une durée de réponse de 12 mois de 82,3 % dans le traitement du cancer de la vessie non musculaire invasif à faible grade et à risque intermédiaire.
UroGen Pharma hat die finanziellen Ergebnisse des dritten Quartals 2024 veröffentlicht und die Akzeptanz des Antrags auf Neuzulassung von UGN-102 durch die FDA hervorgehoben, mit einem PDUFA-Datum am 13. Juni 2025. JELMYTO erzielte im dritten Quartal 2024 Nettoumsätze von 25,2 Millionen US-Dollar, ein Anstieg von 20,9 Millionen US-Dollar im dritten Quartal 2023. Das Unternehmen berichtete über einen Nettoverlust von 23,7 Millionen US-Dollar (0,55 US-Dollar pro Aktie) und hielt eine starke Zahlungsmittelposition von 254,2 Millionen US-Dollar aufrecht. Die Phase-3-Studie ENVISION für UGN-102 zeigte eine vollständige Ansprechrate von 79,6 % und eine Ansprechdauer von 12 Monaten von 82,3 % bei der Behandlung von nicht muskelinvasivem Blasenkarzinom mit niedrigem Grad und mittlerem Risiko.
- JELMYTO revenue increased 20.6% YoY to $25.2 million in Q3 2024
- Strong cash position of $254.2 million as of September 30, 2024
- FDA acceptance of UGN-102 NDA with PDUFA date set for June 13, 2025
- Phase 3 ENVISION trial met primary endpoint with 79.6% complete response rate
- Net loss increased to $23.7 million in Q3 2024 from $21.9 million in Q3 2023
- Operating expenses increased to $40.3 million from $32.0 million YoY
- Company expects full-year JELMYTO revenues to be below previous guidance
- SG&A expenses increased 32.7% YoY to $28.9 million
Insights
The Q3 results present a mixed financial picture. While
Key concerns include widening operating losses of
The FDA acceptance of UGN-102's NDA represents significant clinical validation. The Phase 3 ENVISION trial data is particularly impressive, with a
The new patent allowance extending to 2041 for UGN-103 provides important IP protection. The technology platform shows promise in addressing both upper and lower tract urothelial cancers, potentially establishing UroGen as a leader in this therapeutic area.
- New Drug Application for UGN-102 accepted by US FDA; PDUFA target action date set for June 13, 2025
-
JELMYTO® achieved net product sales of
$25.2 million $20.9 million -
$254.2 million - Conference call and webcast to be held today at 10:00 AM ET
“The recent FDA acceptance of our New Drug Application for UGN-102 marks a significant milestone in our mission to deliver breakthrough treatments to patients,” said Liz Barrett, President and Chief Executive Officer of UroGen. “Supported by robust clinical evidence, we believe UGN-102 has the potential to redefine the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer and provide longer treatment-free intervals for patients that currently face the burden of repetitive surgeries under general anesthesia. We look forward to a potential FDA approval by the PDUFA target action date of June 13, 2025. If approved, we believe UGN-102 will represent a paradigm shift in care, addressing a total market opportunity of over
Q3 2024 and Recent Business Highlights:
UGN-102 (mitomycin) for intravesical solution:
-
In October 2024, the
U.S. Food and Drug Administration (FDA) accepted UroGen’s New Drug Application (NDA) for investigational drug UGN-102 (mitomycin) for intravesical solution as a treatment for low-grade intermediate risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The FDA granted a Prescription Drug User Fee Act (PDUFA) target action date of June 13, 2025. -
The NDA for UGN-102 is supported by a comprehensive development program which demonstrated a clinically meaningful complete response rate and a strong duration of response across three late phase clinical trials and an acceptable safety profile. The Phase 3 ENVISION trial successfully met its primary endpoint by demonstrating that patients treated with UGN-102 had a
79.6% (95% CI,73.9% ,84.5% ) complete response (CR) rate at three months following the first instillation of UGN-102. More recently, durability data from ENVISION showed that UGN-102 demonstrated an82.3% (95% CI,75.9% ,87.1% ) 12-month duration of response (DOR) by Kaplan-Meier estimate in patients who had achieved a complete response at three months after the first instillation of UGN-102. This is the highest DOR ever reported in this patient population. The ENVISION trial demonstrated that UGN-102 has an acceptable safety profile that is consistent with the side effect profile observed in previous clinical trials.
JELMYTO (mitomycin) for pyelocalyceal solution in low-grade upper tract urothelial cancer (LG-UTUC):
-
Generated net product revenue of
$25.2 million $20.9 million
Next-generation novel mitomycin-based formulation for urothelial cancers
- In October 2024, the first patient was dosed in the Phase 3 UTOPIA clinical trial of investigational drug UGN-103 (mitomycin) for intravesical solution in patients with LG-IR-NMIBC. UGN-103 is a next generation product that combines UroGen’s RTGel® technology with a novel mitomycin formulation licensed from medac GmbH. UGN-103 is planned to follow the potential FDA approval and launch of UGN-102 for LG-IR-NMIBC. UroGen plans to initiate a Phase 3 study early next year to explore the safety and efficacy of UGN-104, its next generation product for the treatment of LG-UTUC. To learn more about the UTOPIA trial, refer to clinicaltrials.gov/NCT06331299.
-
In September 2024, UroGen received a Notice of Allowance from the United States Patent and Trademark Office for a patent application covering, among other things, the use of UGN-103 in the treatment of LG-IR-NMIBC. The
U.S. patent, once issued, will have an expiration date in December 2041.
Corporate
- In October 2024, UroGen appointed Chris Degnan as Chief Financial Officer. Mr. Degnan brings broad expertise in financial strategy, investor relations, SEC reporting, accounting and compliance, having previously held CFO roles at Galera Therapeutics and Verrica Pharmaceuticals. He replaced Don Kim who left the Company to pursue other opportunities.
Third Quarter 2024 Financial Results
JELMYTO Revenue: JELMYTO net product revenues were
R&D Expense: Research and development expenses for the third quarter of 2024 were
SG&A Expense: Selling, general and administrative expenses for the third quarter of 2024 were
Financing on Prepaid Forward Obligation: UroGen reported non-cash financing expense related to the prepaid forward obligation to RTW Investments of
Interest Expense on Long-Term Debt: Interest expense related to the outstanding
Net Loss: UroGen reported a net loss of
Cash & Cash Equivalents: As of September 30, 2024, cash, cash equivalents and marketable securities totaled
For further details on the Company’s financials, including results for the 9-month period ended September 30, 2024, refer to Form 10-Q, filed with the SEC.
2024 Revenue, Operating Expense, and RTW Expense Guidance: With respect to the Company’s previously provided full-year 2024 JELMYTO revenue guidance, the Company expects full-year revenues to be below the low end of the guidance range. The Company does expect JELMYTO to achieve low double-digit year-over-year revenue growth for the full year 2024. With respect to the Company’s previously provided full-year 2024 operating expenses guidance, the Company expects to be toward the midpoint of the guidance range, including non-cash share-based compensation expense of
Conference Call & Webcast Information: Members of UroGen’s management team will host a live conference call and webcast today at 10:00 AM Eastern Time to review UroGen’s financial results and provide a general business update.
The live webcast can be accessed by visiting the Investors section of the Company’s website at http://investors.UroGen.com. Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast.
UROGEN PHARMA LTD. |
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SELECTED CONSOLIDATED BALANCE SHEETS |
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(Unaudited) |
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September 30, 2024 |
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December 31, 2023 |
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Cash and cash equivalents and marketable securities |
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$ |
254,217 |
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$ |
141,470 |
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Total assets |
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$ |
301,943 |
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$ |
178,311 |
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Total liabilities |
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$ |
276,428 |
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$ |
243,523 |
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Total shareholders' equity (deficit) |
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$ |
25,515 |
|
$ |
(65,212 |
) |
UROGEN PHARMA LTD. |
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS |
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(Unaudited) |
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Three months ended September 30, |
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Nine months ended September 30, |
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2024 |
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2023 |
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2024 |
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2023 |
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Revenue1 |
$ |
25,204 |
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$ |
20,852 |
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$ |
65,833 |
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|
$ |
59,183 |
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|
Cost of revenue |
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2,543 |
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|
|
2,367 |
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|
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6,410 |
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|
|
7,075 |
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Gross profit |
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22,751 |
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18,485 |
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59,423 |
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52,108 |
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Operating expenses: |
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Research and development expenses |
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11,355 |
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|
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10,230 |
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|
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42,251 |
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|
|
34,312 |
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|
Selling, general and administrative expenses |
|
28,941 |
|
|
|
21,755 |
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|
|
86,296 |
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|
|
68,723 |
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Total operating expenses |
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40,296 |
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|
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31,985 |
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|
|
128,547 |
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|
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103,035 |
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Operating loss |
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(17,545 |
) |
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(13,500 |
) |
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(69,124 |
) |
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(50,927 |
) |
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Financing on prepaid forward obligation |
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(5,915 |
) |
|
|
(5,479 |
) |
|
|
(17,348 |
) |
|
|
(16,047 |
) |
|
Interest expense on long-term debt |
|
(2,721 |
) |
|
|
(3,815 |
) |
|
|
(8,629 |
) |
|
|
(11,129 |
) |
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Interest and other income, net |
|
2,599 |
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|
|
906 |
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|
|
5,922 |
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|
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1,941 |
|
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Loss before income taxes |
$ |
(23,582 |
) |
|
$ |
(21,888 |
) |
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$ |
(89,179 |
) |
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$ |
(76,162 |
) |
|
Income tax expense |
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(91 |
) |
|
|
9 |
|
|
|
(183 |
) |
|
|
(66 |
) |
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Net loss |
$ |
(23,673 |
) |
|
$ |
(21,879 |
) |
|
$ |
(89,362 |
) |
|
$ |
(76,228 |
) |
|
Net loss per ordinary share basic and diluted |
$ |
(0.55 |
) |
|
$ |
(0.68 |
) |
|
$ |
(2.36 |
) |
|
$ |
(2.89 |
) |
|
Weighted average shares outstanding, basic and diluted |
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43,100,237 |
|
|
|
32,298,182 |
|
|
|
37,797,492 |
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|
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26,358,719 |
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1. |
JELMYTO net revenues include |
About JELMYTO
JELMYTO® (mitomycin) for pyelocalyceal solution is a mitomycin-containing reverse thermal gel containing 4 mg mitomycin per mL gel indicated for the treatment of adult patients with LG-UTUC. It is recommended for primary treatment of biopsy-proven LG-UTUC in patients deemed appropriate candidates for renal-sparing therapy. JELMYTO is a viscous liquid when cooled and becomes a semi-solid gel at body temperature. The drug slowly dissolves over four to six hours after instillation and is removed from the urinary tract by normal urine flow and voiding. It is approved for administration in a retrograde manner via ureteral catheter or antegrade through nephrostomy tube. The delivery system allows the initial liquid to coat and conform to the upper urinary tract anatomy. The eventual semisolid gel allows for chemoablative therapy to remain in the collecting system for four to six hours without immediately being diluted or washed away by urine flow.
APPROVED USE FOR JELMYTO
JELMYTO® is a prescription medicine used to treat adults with a type of cancer of the lining of the upper urinary tract including the kidney called low-grade Upper Tract Urothelial Cancer (LG-UTUC).
IMPORTANT SAFETY INFORMATION
You should not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract.
Before receiving JELMYTO, tell your healthcare provider about all your medical conditions, including if you:
- are pregnant or plan to become pregnant. JELMYTO can harm your unborn baby. You should not become pregnant during treatment with JELMYTO. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with JELMYTO. Females who are able to become pregnant: You should use effective birth control (contraception) during treatment with JELMYTO and for 6 months after the last dose. Males being treated with JELMYTO: If you have a female partner who is able to become pregnant, you should use effective birth control (contraception) during treatment with JELMYTO and for 3 months after the last dose.
- are breastfeeding or plan to breastfeed. It is not known if JELMYTO passes into your breast milk. Do not breastfeed during treatment with JELMYTO and for 1 week after the last dose.
- Tell your healthcare provider if you take water pills (diuretic).
How will I receive JELMYTO?
- Your healthcare provider will tell you to take a medicine called sodium bicarbonate before each JELMYTO treatment.
- You will receive your JELMYTO dose from your healthcare provider 1 time a week for 6 weeks. It is important that you receive all 6 doses of JELMYTO according to your healthcare provider’s instructions. If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment. Your healthcare provider may recommend up to an additional 11 monthly doses.
- JELMYTO is given to your kidney through a tube called a catheter.
- During treatment with JELMYTO, your healthcare provider may tell you to take additional medicines or change how you take your current medicines.
After receiving JELMYTO:
- JELMYTO may cause your urine color to change to a violet to blue color. Avoid contact between your skin and urine for at least 6 hours.
- To urinate, males and females should sit on a toilet and flush the toilet several times after you use it. After going to the bathroom, wash your hands, your inner thighs, and genital area well with soap and water.
- Clothing that comes in contact with urine should be washed right away and washed separately from other clothing.
JELMYTO may cause serious side effects, including:
- Swelling and narrowing of the tube that carries urine from the kidney to the bladder (ureteric obstruction). If you develop swelling and narrowing, and to protect your kidney from damage, your healthcare provider may recommend the placement of a small plastic tube (stent) in the ureter to help the kidney drain. Tell your healthcare provider right away if you develop side pain or fever during treatment with JELMYTO.
- Bone marrow problems. JELMYTO can affect your bone marrow and can cause a decrease in your white blood cell, red blood cell, and platelet counts. Your healthcare provider will do blood tests prior to each treatment to check your blood cell counts during treatment with JELMYTO. Your healthcare provider may need to temporarily or permanently stop JELMYTO if you develop bone marrow problems during treatment with JELMYTO.
- The most common side effects of JELMYTO include: urinary tract infection, blood in your urine, side pain, nausea, trouble with urination, kidney problems, vomiting, tiredness, stomach (abdomen) pain.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088. You may also report side effects to UroGen Pharma at 1-855-987-6436.
Please see JELMYTO Full Prescribing Information, including the Patient Information, for additional information.
About Upper Tract Urothelial Cancer (UTUC)
Urothelial cancer is the ninth most common cancer globally and the eighth most lethal neoplasm in men in the
About UGN-102
UGN-102 (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin, currently under regulatory review for approval in the treatment of LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel® technology, a sustained release, hydrogel-based formulation, UGN-102 is designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. UGN-102 is delivered to patients using a standard urinary catheter in an outpatient setting by a trained healthcare professional. An NDA for UGN-102 is currently under review by the FDA with a potential decision expected by June 13, 2025. The U.S. market for LG-IR-NMIBC that UGN-102 can address, if approved, is valued at approximately
About UroGen Pharma Ltd.
UroGen is a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers because patients deserve better options. UroGen has developed RTGel reverse-thermal hydrogel, a proprietary sustained-release, hydrogel-based platform technology that has the potential to improve the therapeutic profiles of existing drugs. UroGen’s sustained release technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option. Our first product to treat low-grade upper tract urothelial cancer and investigational treatment UGN-102 (mitomycin) for intravesical solution for patients with LG-IR-NMIBC are designed to ablate tumors by non-surgical means. UroGen is headquartered in
Forward-Looking Statements
This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, statements regarding: the potential timing for a decision from the FDA on the UGN-102 NDA; the potential launch timing for UGN-102, if approved; the potential patient benefits and opportunities for UGN-102, if approved; the estimated size of the U.S. market that could be addressed by UGN-102, if approved; the plans for UGN-103 to follow the potential FDA approval and launch of UGN-102; the timing for the planned Phase 3 trial of UGN-103 and UGN-104 and the potential approval of both product candidates; the anticipated intellectual property protection for UGN-103; 2024 financial guidance; the estimated patient population and demographics for UTUC; the potential of UroGen’s proprietary RTGel technology to improve therapeutic profiles of existing drugs; and the potential of UroGen’s sustained release technology to make local delivery more effective as compared to other treatment options. Words such as “anticipate,” “believe,” “expect,” “if,” “plan,” “potential,” “will,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to: the timing and success of clinical trials and potential safety and other complications thereof; unforeseen delays that may impact the timing of progressing clinical trials and reporting data; results from the ENVISION Phase 3 trial may not be sufficient to support an NDA submission for UGN-102; even though the NDA for UGN-102 has been accepted by the FDA, there is no guarantee that such NDA will be sufficient to support approval of UGN-102 on the timeframe expected, or at all; the PDUFA target action date may be delayed due to various factors outside UroGen’s control; the FDA may schedule an advisory committee meeting for UGN-102, and the impact of any such advisory committee meeting or recommendation on the approval decision by the FDA is uncertain; the ability to obtain and maintain adequate intellectual property rights and adequately protect and enforce such rights; past results are not necessarily indicative of results that may be seen in the future, including in larger patient populations; the ability to obtain and maintain regulatory approval within the timeframe expected, or at all; complications associated with commercialization activities; the labeling for any approved product; competition in UroGen’s industry; the scope, progress and expansion of developing and commercializing UroGen’s product candidates; the size and growth of the market(s) therefor and the rate and degree of market acceptance thereof vis-à-vis alternative therapies or procedures, such as surgery; UroGen’s ability to attract or retain key management, members of the board of directors and other personnel; UroGen’s RTGel technology may not perform as expected; UroGen may not successfully develop and receive regulatory approval of any other product that incorporates RTGel technology; and UroGen’s financial condition and need for additional capital in the future. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section of UroGen’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, filed with the SEC on August 13, 2024, as well as in the Risk Factors section of UroGen’s Quarterly Report on Form 10-Q being filed with the SEC later today (which is available at www.sec.gov), the events and circumstances discussed in such forward-looking statements may not occur, and UroGen’s actual results could differ materially and adversely from those anticipated or implied thereby. Any forward-looking statements speak only as of the date of this press release and are based on information available to UroGen as of the date of this release.
View source version on businesswire.com: https://www.businesswire.com/news/home/20241106678091/en/
INVESTOR CONTACT:
Vincent Perrone
Senior Director, Investor Relations
vincent.perrone@UroGen.com
609-460-3588 ext. 1093
MEDIA CONTACT:
Cindy Romano
Director, Corporate Communications
cindy.romano@UroGen.com
609-460-3583 ext. 1083
Source: UroGen Pharma Ltd.
FAQ
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