UroGen Pharma Delivers Double Digit JELMYTO® Growth and Prepares for the Next Phase of the Company with on Track Rolling Submission of UGN-102
- Initiation of NDA submission for UGN-102 with promising ENVISION trial data
- JELMYTO achieved $82.7 million in net product revenues in 2023, a 28% increase from 2022
- New agreement with Pharmakon Advisors for up to $100 million credit facility
- Positive growth in JELMYTO revenue but impacted by higher expenses
- Higher than forecast 340B chargebacks and Medicare refunds impacting net revenues
- Increased operating expenses and financing expenses affecting the financials
Insights
The reported increase in net product revenues for JELMYTO, amounting to $82.7 million, represents a significant 28% growth year-over-year. This growth is indicative of successful market penetration and increasing adoption by healthcare providers. However, the disclosure of higher than anticipated 340B chargebacks and Medicare refunds for discarded drug suggests a pressure on margins that could affect profitability. Investors should monitor the company's ability to manage these cost pressures while sustaining revenue growth.
Furthermore, the restructured loan agreement with Pharmakon Advisors, providing an additional credit facility of up to $100 million, may offer the company a financial cushion to support its operations. This is critical as it extends the runway for UroGen to reach key milestones without immediate dilution to shareholders. Nevertheless, the long-term impact of the increased debt burden, including interest expenses, on the company's financial health warrants careful scrutiny.
The initiation of a rolling New Drug Application (NDA) for UGN-102 is a pivotal step for UroGen, with the potential to tap into a $3 billion market opportunity. The emphasis on the drug's duration of response, as evidenced by the ENVISION trial, is a critical factor for FDA approval and could establish UGN-102 as a non-surgical treatment option for LG-IR-NMIBC. The medical community will be closely watching the 12-month duration of response data, which could significantly influence treatment paradigms.
Moreover, the next-generation mitomycin-based RTGel formulations, UGN-103 and UGN-104, present an opportunity for UroGen to solidify its position in the urothelial cancer market. The potential extension of patent protection until December 2041 could provide a long-term competitive advantage. However, the success of these formulations hinges on the outcomes of the upcoming Phase 3 studies.
The projected revenue guidance for JELMYTO in 2024, ranging from $95 to $102 million, suggests a continued trajectory of growth. Yet, it's important to note that this forecast also accounts for increased discounts and rebates, which could dampen net revenue figures. The market's response to these financial projections will likely reflect both the optimism for growth and the caution due to potential margin compressions.
Additionally, the company's strategic licensing agreement with medac GmbH for novel mitomycin formulations could be a game-changer, offering a diversified product pipeline with extended intellectual property protection. This move could be interpreted as a proactive approach to sustaining long-term growth and market presence, potentially influencing investor confidence positively.
- Initiated submission of a rolling NDA to the FDA for UGN-102; 12-month duration of response data from ENVISION expected to support completion of NDA submission
- Announced next-generation novel mitomycin-based RTGel formulations for LG-IR-NMIBC and LG-UTUC programs from medac GmbH licensing agreement with potential IP protection until December 2041
-
JELMYTO® achieved net product revenues of
$82.7 million 28% compared with 2022 -
Announced signing of a restructured agreement with Pharmakon Advisors that provides more favorable terms and provides UroGen up to an additional
$100 million - Conference call and webcast to be held today at 10:00 AM ET
“In 2023, UroGen achieved important operational and clinical milestones, setting us up for further success in the coming years,” said Liz Barrett, President and Chief Executive Officer of UroGen. “The Phase 3 ATLAS and ENVISION trials both produced meaningful and unprecedented results underscoring the potential of UGN-102 to fundamentally change the way patients with low-grade intermediate-risk non-muscle invasive bladder cancer are treated. We look forward to reporting the 12-month duration of response data from ENVISION in the second quarter of 2024 and to completing submission of an NDA in September of this year. UGN-102 has the potential to address a more than
2023 and Recent Business Highlights:
UGN-102 (mitomycin) for intravesical solution:
-
In January 2024, UroGen initiated submission of a rolling New Drug Application (NDA) to the
U.S. Food and Drug Administration (FDA) for UGN-102 as a treatment of low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The first part of the submission was the Chemistry, Manufacturing and Controls (CMC) sections. The FDA indicated that evaluation of duration of complete response at 12-months from the pivotal ENVISION trial will be sufficient to support submission of the NDA. The company plans to complete the submission in September 2024 with a potential FDA decision as early as the first quarter of 2025. - Positive top-line data from ATLAS Phase 3 clinical trial highlighting UGN-102 as non-surgical treatment option for LG-IR-NMIBC published in The Journal of Urology.
JELMYTO (mitomycin) for pyelocalyceal solution in low-grade upper tract urothelial cancer (LG-UTUC):
-
Generated annual net product revenue of
$82.7 million $64.4 million 28% annual growth. -
Patient enrollment forms, new patient starts, and total doses each grew approximately
25% year-over-year. First-time writers, activated sites and repeat accounts also continue to grow. -
A retrospective study investigated whether patients with higher-volume low-grade disease could achieve disease-free status using partial ablation or biopsy before JELMYTO treatment during initial ureteroscopy. The study found no significant difference in disease-free rates between complete ablation (
78.6% ), partial ablation (57.6% ), or biopsy-only (66.7% ) groups during initial ureteroscopy. Tumor size prior to JELMYTO induction also showed no significant impact on disease-free rates. The study aimed to find alternatives to nephroureterectomy for preserving kidney function and to assess JELMYTO's efficacy in managing larger volume disease. Findings from the study were published online in Urologic Oncology: Seminars and Original Investigations online.
Next-generation novel mitomycin-based formulation for urothelial cancers
-
In January 2024, UroGen announced a license and supply agreement with medac GmbH to develop a next-generation novel mitomycin-based formulation for urothelial cancers. UGN-103 and UGN-104 combine UroGen’s RTGel® technology with medac’s licensed mitomycin formulation. The agreement and development program potentially allow UroGen to extend the patent protection on its urothelial cancer franchise. medac has intellectual property protection for its mitomycin formulation expected to last until June 2035 and UroGen has pending
U.S. patent applications which may provide protection until December 2041. - UroGen plans to initiate Phase 3 studies to explore the safety and efficacy of UGN-103 and UGN-104 in LG-IR-NMIBC and LG-UTUC, respectively, in 2024.
Up to
-
Announced signing of a restructured loan agreement with Pharmakon Advisors providing UroGen additional funding of up to
$100 million $100 million $100 million $25 million $75 million
Fourth Quarter and Full Year 2023 Financial Results
JELMYTO Revenue: UroGen reported JELMYTO net product revenues of
R&D Expense: Research and development expenses for the fourth quarter of 2023 were
SG&A Expense: Selling, general and administrative expenses for the fourth quarter of 2023 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
Net Loss: UroGen reported a net loss of
Cash & Cash Equivalents: As of December 31, 2023, cash, cash equivalents and marketable securities totaled
2024 Revenue, Operating Expense and RTW Expense Guidance: The Company anticipates full year 2024 net product revenues from JELMYTO to be in the range 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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December 31,
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December 31,
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Cash and cash equivalents and marketable securities |
|
$ |
141,469 |
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$ |
99,963 |
|
Total assets |
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$ |
178,311 |
|
|
$ |
135,619 |
|
Total liabilities |
|
$ |
243,523 |
|
|
$ |
224,980 |
|
Total shareholders' deficit |
|
$ |
(65,212 |
) |
|
$ |
(89,361 |
) |
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UROGEN PHARMA LTD. |
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CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS |
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(Unaudited) |
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Three months ended
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Year ended December 31, |
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2023 |
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2022 |
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2023 |
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2022 |
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Revenue1 |
$ |
23,530 |
|
|
$ |
18,092 |
|
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$ |
82,713 |
|
|
$ |
64,357 |
|
|
Cost of revenue |
|
2,286 |
|
|
|
2,263 |
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|
|
9,361 |
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|
|
7,654 |
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|
Gross profit |
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21,244 |
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15,829 |
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73,352 |
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|
56,703 |
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Operating expenses: |
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Research and development expenses |
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11,302 |
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|
|
14,477 |
|
|
|
45,614 |
|
|
|
52,906 |
|
|
Selling, general and administrative expenses |
|
24,551 |
|
|
|
21,634 |
|
|
|
93,274 |
|
|
|
82,838 |
|
|
Total operating expenses |
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35,853 |
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|
|
36,111 |
|
|
|
138,888 |
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|
|
135,744 |
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Operating loss |
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(14,609 |
) |
|
|
(20,282 |
) |
|
|
(65,536 |
) |
|
|
(79,041 |
) |
|
Financing on prepaid forward obligation |
|
(5,505 |
) |
|
|
(5,081 |
) |
|
|
(21,552 |
) |
|
|
(21,559 |
) |
|
Interest expense on long-term debt |
|
(3,586 |
) |
|
|
(3,223 |
) |
|
|
(14,715 |
) |
|
|
(8,438 |
) |
|
Interest and other income, net |
|
1,538 |
|
|
|
406 |
|
|
|
3,479 |
|
|
|
1,010 |
|
|
Loss before income taxes |
$ |
(22,162 |
) |
|
$ |
(28,180 |
) |
|
$ |
(98,324 |
) |
|
$ |
(108,028 |
) |
|
Income tax expense |
|
(3,854 |
) |
|
|
(689 |
) |
|
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(3,920 |
) |
|
|
(1,775 |
) |
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Net loss |
$ |
(26,016 |
) |
|
$ |
(28,869 |
) |
|
$ |
(102,244 |
) |
|
$ |
(109,783 |
) |
|
Net loss per ordinary share basic and diluted |
$ |
(0.72 |
) |
|
$ |
(1.25 |
) |
|
$ |
(3.55 |
) |
|
$ |
(4.81 |
) |
|
Weighted average shares outstanding, basic and diluted |
|
36,153,634 |
|
|
|
23,088,891 |
|
|
|
28,834,303 |
|
|
|
22,806,812 |
|
|
1. |
2023 full-year JELMYTO net revenues include gross-to-net unfavorability driven by higher 340B chargebacks and estimated Medicare refunds for discarded drugs, offset by |
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 in Phase 3 development for the treatment of low-grade, intermediate-risk, non-muscle invasive bladder cancer (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. Assuming positive findings from the durability of response endpoint from the ENVISION Phase 3 study, UroGen anticipates completing its NDA submission for UGN-102 in September with a potential FDA decision as early as the first quarter of 2025.
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 low-grade non-muscle invasive bladder cancer 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: operational and clinical milestones achieved in 2023 will set the Company up for further success in the coming years; the potential of UGN-102 to fundamentally change the way patients with LG-IR-NMIBC are treated; the expected timing for the release of 12-month duration of response data from ENVISION in the second quarter of 2024 and that such data will be sufficient to support the submission of an NDA for UGN-102; the expected timing for completing a submission of an NDA to the FDA for UGN-102 and the potential FDA decision; the potential of UGN-102 to address more than
View source version on businesswire.com: https://www.businesswire.com/news/home/20240314112098/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
What is the net product revenue achieved by JELMYTO in 2023?
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