- 12-month duration of response data from ENVISION study of
UGN-102 to be discussed during company sponsored virtual event on
June 13, 2024
- ENVISION data expected to support completion of UGN-102 NDA in
Q3 2024
- Post-hoc analysis of OLYMPUS study for JELMYTO shows
disease-free periods more than 47.8 months in LG-UTUC
- JELMYTO® demonstrated continued growth with net product sales
of $18.8 million in Q1, compared with $17.2 million in Q1
2023 representing ~10% YoY growth
- IND accepted for UGN-103, next-generation novel mitomycin-based
formulation of UGN-102 to treat LG-IR-NMIBC
- Conference call and webcast to be held today at 10:00 AM
ET
UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated
to developing and commercializing innovative solutions that treat
urothelial and specialty cancers, today announced financial results
for the first quarter ended March 31, 2024, and provided an
overview of recent developments.
“In 2024 to date, UroGen has made excellent progress in both our
commercial business and pipeline of innovative products designed to
treat urothelial and specialty cancers,” said Liz Barrett,
President, and Chief Executive Officer of UroGen. “The upcoming
announcement of 12-month duration of response results from ENVISION
will be a key clinical milestone and we expect the data to support
completion of our NDA for UGN-102. Pre-launch activities are
underway and we estimate that UGN-102 will address a more than $3
billion market opportunity. If approved, we believe this product
will become the major growth driver for UroGen and could establish
a new standard of care in LG-IR-NMIBC.”
Q1 2024 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 company plans
to complete the submission in Q3 2024 with a potential FDA decision
as early as the first quarter of 2025.
- In May 2024, a subgroup analysis from the UGN-102 ATLAS trial
was featured in a podium presentation at the American Urological
Association (AUA) 2024 Annual Meeting in San Antonio, Texas. The
analysis showed that patients with new and recurrent LG-IR-NMIBC
treated with UGN-102 ± TURBT (trans urethral resection of bladder
tumor) had high probabilities of remaining event-free for disease
free survival (DFS) and high probabilities of remaining in complete
response.
JELMYTO (mitomycin) for pyelocalyceal solution in low-grade
upper tract urothelial cancer (LG-UTUC):
- A soon-to-be-published post-hoc analysis of the OLYMPUS trial
assessed the long-term effects in treating LG-UTUC with JELMYTO. Of
the 71 patients who enrolled in OLYMPUS, 41 achieved a
complete-response and their health outcomes were tracked for up to
12 months. 20 of these patients remaining in CR enrolled in a
5-year rollover study. All 41 patients with an initial CR indicated
a promising median duration of response of 47.8 months, based on a
median follow-up of 28.1 months. In the 5-year rollover trial, 75%
(N=15) showed no disease recurrence, indicating potential for
extended disease-free periods.
- JELMYTO was featured in three presentations at the AUA 2024
Annual Meeting. Independent long-term real-world analyses explored
use of the product in broad patient types and with different
methods of administration. The results show that JELMYTO treatment
demonstrated favorable recurrence free survival rates for patients
with LG-UTUC who respond to initial induction. The results were
consistent regardless of JELMYTO administration, original tumor
size, multifocality or tumor location.
- Continued strong demand for Jelmyto with record patient
enrollments forms. Generated net product revenue of $18.8 million
in the first quarter of 2024, compared with $17.2 million in the
first quarter of 2023, representing ~10% annual growth.
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 offer both manufacturing efficiencies and IP protection
for the Company’s next-generation urothelial cancer franchise.
- In April 2024, the FDA accepted the Company’s Investigational
New Drug (IND) application for UGN-103. If approved, UGN-103 is
expected to provide several advantages related to production, cost,
supply, and product convenience.
- UroGen plans to initiate Phase 3 studies to explore the safety
and efficacy of UGN-103 in LG-IR-NMIBC in 2024 and UGN-104 in
LG-UTUC shortly thereafter.
First Quarter 2024 Financial Results
JELMYTO Revenue: JELMYTO net product revenues were $18.8
million and $17.2 million for the three months ended March 31, 2024
and 2023, respectively.
R&D Expense: Research and development expenses for
the first quarter of 2024 were $15.5 million, including non-cash
share-based compensation expense of $0.5 million as compared to
$12.5 million, including non-cash share-based compensation expense
of $0.5 million, for the same period in 2023.
SG&A Expense: Selling, general and administrative
expenses for the first quarter of 2024 were $27.3 million,
including non-cash share-based compensation expense of $2.2
million. This compares to $24.5 million, including non-cash
share-based compensation expense of $1.8 million, for the same
period in 2023.
Financing on Prepaid Forward Obligation: UroGen reported
non-cash financing expense related to the prepaid forward
obligation to RTW Investments of $5.7 million in the first quarter
of 2024, compared to $5.2 million in the same period in 2023.
Interest Expense on Long-Term Debt: Interest expense
related to the $100 million term loan facility with funds managed
by Pharmakon Advisors was $2.4 million in the first quarter of
2024, compared to $3.6 million in the same period in 2023.
Net Loss: UroGen reported a net loss of $32.3 million or
($0.97) per basic and diluted share in the first quarter of 2024
compared with a net loss of $30.2 million or ($1.30) per basic and
diluted share in the same period in 2023.
Cash & Cash Equivalents: As of March 31, 2024, cash,
cash equivalents and marketable securities totaled $164.5
million.
2024 Revenue, Operating Expense and RTW Expense Guidance:
The Company is reiterating full year 2024 net product revenues
guidance from JELMYTO in the range of $95 to $102 million.
Increased discounts related to Medicare refunds for discarded drugs
and 340B purchases will further impact net revenues in 2024. The
Company also expects full year 2024 operating expenses in the range
of $175 to $185 million, including non-cash share-based
compensation expense of $6 to $11 million, subject to market
conditions. The Company also reiterates the anticipated full year
2024 non-cash financing expense related to the prepaid obligation
to RTW Investments in the range of $21 to $26 million. Of this
amount approximately $12.4 to $13.3 million is expected to be in
cash.
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.
SELECTED CONSOLIDATED BALANCE
SHEETS
(U.S. dollars in thousands)
(Unaudited)
March 31, 2024
December 31, 2023
Cash and cash equivalents and marketable
securities
$
164,525
$
141,470
Total assets
$
200,574
$
178,311
Total liabilities
$
240,708
$
243,523
Total shareholders' deficit
$
(40,134
)
$
(65,212
)
UROGEN PHARMA LTD.
CONDENSED CONSOLIDATED STATEMENTS
OF OPERATIONS AND COMPREHENSIVE LOSS
(U.S. dollars in thousands,
except share and per share data)
(Unaudited)
Three months ended March 31,
2024
2023
Revenue
$
18,781
$
17,192
Cost of revenue
1,728
2,265
Gross profit
17,053
14,927
Operating expenses:
Research and development expenses
15,494
12,498
Selling, general and administrative
expenses
27,299
24,474
Total operating expenses
42,793
36,972
Operating loss
(25,740
)
(22,045
)
Financing on prepaid forward
obligation
(5,660
)
(5,224
)
Interest expense on long-term debt
(2,447
)
(3,553
)
Interest and other income, net
1,615
630
Loss before income taxes
$
(32,232
)
$
(30,192
)
Income tax expense
(54
)
(21
)
Net loss
$
(32,286
)
$
(30,213
)
Net loss per ordinary share, basic and
diluted
$
(0.97
)
$
(1.30
)
Weighted average shares outstanding, basic
and diluted
33,379,786
23,279,951
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. 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 U.S. Between five
percent and ten percent of primary urothelial cancers originate in
the ureter or renal pelvis and are collectively referred to as
upper tract urothelial cancers (UTUC). In the U.S., there are
approximately 6,000 - 7,000 new or recurrent low-grade UTUC
patients annually. Most cases are diagnosed in patients over 70
years old, and these older patients often face comorbidities. There
are limited treatment options for UTUC, with the most common being
endoscopic surgery or nephroureterectomy (removal of the entire
kidney and ureter). These treatments can lead to a high rate of
recurrence and relapse.
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 Princeton, NJ with operations in Israel. Visit
www.UroGen.com to learn more or follow us on X (Twitter),
@UroGenPharma.
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
Phase 3 ENVISION trial, including the expected release of data in
June 2024; the estimated addressable patient population and market
and revenue opportunity for UGN-102; the expectation UGN-102 will
be a significant driver of UroGen’s future growth; potential for
UGN-102 to establish a new standard of care in LG-IR-NMIBC;
UroGen’s plans to complete its NDA submission for UGN-102 in the
third quarter of 2024, with a potential FDA decision as early as
the first quarter of 2025; the potential advantages of treatment
with UGN-102 ± TURBT over TURBT alone; publication of the post-hoc
analysis of the OLYMPUS trial that assessed the long-term effects
in treating LG-UTUC with JELMYTO; the interpretation and summary of
results of ENVISION, OLYMPUS, and ATLAS trials; potential for the
license and supply agreement with medac to offer both manufacturing
efficiencies and IP protection; the timing for the planned Phase 3
trial of UGN-103 and the potential approval of UGN-103; the timing
of the planned Phase 3 trial of UGN-104;; 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,” “could,”
“may,” “plan,” “potential,” “soon-to-be,” “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: preliminary results may not be indicative of results
that may be observed in the future; 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; findings from the
durability of response endpoint from the ENVISION Phase 3 study may
not be sufficient to support UroGen’s NDA; even if an NDA for
UGN-102 is 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 ability to obtain regulatory approval
within the timeframe expected, or at all; the ability to obtain and
maintain adequate intellectual property rights and adequately
protect and enforce such rights; the ability to maintain regulatory
approval; 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) for UroGen’s product and product candidates
and the rate and degree of market acceptance thereof vis-à-vis
alternative therapies; UroGen’s ability to attract or retain key
management, members of the board of directors and 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 Annual Report on Form 10-K for the year ended December 31,
2023, filed with the SEC on March 14, 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, 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/20240513271801/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
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