- Continued strong growth with JELMYTO® net product revenues of
$20.9 million in Q3 2023; an increase of ~30% from the same period
last year
- Agreement with United States Food & Drug Administration
(FDA) to proceed with rolling New Drug Application (NDA) for
UGN-102 beginning in January 2024
- 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 third quarter ended September 30, 2023, and provided an
overview of recent developments.
“During the third quarter, UroGen achieved several notable
milestones, including announcement of unprecedented positive
results from our ENVISION and ATLAS Phase 3 trials of UGN-102 in
LG-IR-NMIBC,” said Liz Barrett, President, and Chief Executive
Officer of UroGen. “Those seminal events paved the way for our
recent pre-NDA meeting with the FDA where we aligned with the
Agency on an efficient, rolling NDA review for UGN-102 starting in
2024. If approved, UGN-102 will be the first medicine approved for
this patient population. The NDA will leverage the full strength of
our clinical data with ENVISION as the pivotal trial and
underscores our unwavering commitment to transforming the
LG-IR-NMIBC treatment landscape, as we strive to reduce recurrence
rates and minimize the need for multiple surgeries in this highly
underserved patient population.”
Business Highlights:
UGN-102 (mitomycin) for intravesical solution:
- Announced agreement with the FDA that the current development
plan evaluating duration of response at 12 months from the pivotal
ENVISION trial will support submission of an NDA for the treatment
of LG-IR-NMIBC. The FDA also agreed to a rolling review, allowing
for early submission of the Chemistry, Manufacturing and Controls
(CMC) sections of the NDA, presently slated for January 2024.
- Both ENVISION and ATLAS Phase 3 clinical trials met their
primary endpoints in treating LG-IR-NMIBC.
- ENVISION demonstrated an unprecedented 79.2% complete response
rate (CRR) among 242 patients at three months after first
instillation of UGN-102. Additional data evaluating the key
secondary endpoint of duration of response is expected in Q2
2024.
- The ATLAS trial met its primary endpoint of disease-free
survival, with topline results demonstrating a reduced risk of
recurrence, progression, or death by 55% for UGN-102 ± TURBT. ATLAS
also demonstrated a 64.8% CRR at three months for patients who only
received UGN-102, compared to 63.6% for those patients who only
received TURBT. The estimated probability of remaining disease free
15-months after randomization was 72% for UGN-102 ± TURBT and 50%
for TURBT monotherapy (hazard ratio 0.45).
- Accepted abstracts at the 2023 Society of Urologic Oncology
Annual Meeting
- Late-Breaking Podium Presentation Urothelial Cancer Session
I: Primary chemoablation for recurrent low grade intermediate
risk (LG IR) NMIBC: The ENVISION trial Speaker: Sandip
Prasad, M.D., M.Phil., Director of Genitourinary Surgical Oncology,
Morristown Hospital/Atlantic Health System, NJ Date and
Time: November 30, 2023 at 12:04-12:09 PM ET
- Digital Poster #: 132 Session: Treatment of
low-grade intermediate-risk non muscle invasive bladder cancer with
UGN-102 ± transurethral resection of bladder cancer tumor (TURBT)
monotherapy: the Phase 3 ATLAS trial Date and Time: November
30, 2023 at 2:15-3:15 PM ET
JELMYTO (mitomycin) for pyelocalyceal solution in low-grade
upper tract urothelial cancer (LG-UTUC):
- Generated quarterly net product revenue of $20.9 million for
the third quarter of 2023, representing ~30% growth over the third
quarter of 2022.
- Activated sites on November 1, 2023 were 1,088, compared to
1,058 on August 1, 2023, while repeat accounts on November 1, 2023
were 296, compared to 267 on August 1, 2023.
- A retrospective study titled, The Ablative Effect of Mitomycin
Reverse Thermal Gel: Expanding the Role for Nephron Preservation
Therapy in Low Grade Upper Tract Urothelial Carcinoma, published in
Urologic Oncology: Seminars and Original Investigations online
aimed to explore alternatives to nephroureterectomy for kidney
function preservation and assess JELMYTO's effectiveness in
treating larger volume disease. Findings indicated that there were
no significant differences in disease-free rates between complete
ablation (78.6%), partial ablation (57.6%), or biopsy-only (66.7%)
groups during the initial URS (p=0.15). Additionally, tumor size
before JELMYTO induction did not significantly impact disease-free
rates (p=0.09).
Third Quarter 2023 Financial Results:
JELMYTO Revenue: UroGen reported net product revenue of
JELMYTO for the third quarter 2023 of $20.9 million, compared to
$16.1 million in the third quarter of 2022.
R&D Expense: Research and development expenses for
the third quarter 2023 were $10.2 million, including non-cash
share-based compensation expense of $0.4 million as compared to
$13.1 million, including non-cash share-based compensation expense
of $0.6 million, for the same period in 2022.
SG&A Expense: Selling, general and administrative
expenses for the third quarter 2023 were $21.8 million, including
non-cash share-based compensation expense of $1.8 million. This
compares to $19.1 million, including non-cash share-based
compensation expense of $1.8 million, for the same period in
2022.
Financing on Prepaid Forward Obligation: UroGen reported
non-cash financing expense related to the prepaid forward
obligation to RTW Investments of $5.5 million for the third quarter
2023, compared to $4.8 million for the same period in 2022.
Interest Expense on Long-Term Debt: Interest expense
related to the $100 million term loan facility with funds managed
by Pharmakon Advisors was $3.8 million for the third quarter of
2023, compared to $2.7 million for the same period last year.
Net Loss: UroGen reported a net loss of $21.9 million, or
basic and diluted net loss per ordinary share of $0.68, for the
third quarter 2023 as compared to $25.8 million, or basic and
diluted net loss per ordinary share of $1.13, for the same period
in 2022.
Cash & Cash Equivalents: As of September 30, 2023,
cash, cash equivalents and marketable securities totaled $153.9
million.
2023 Revenue, Operating Expense and RTW Expense Guidance:
The Company reiterates anticipated full year 2023 net product
revenues from JELMYTO to be in the range of $76 to $86 million. The
Company also reiterates anticipated full year 2023 operating
expenses in the range of $135 to $145 million, including non-cash
share-based compensation expense of $6.0 to $11.0 million, subject
to market conditions. The Company also reiterates anticipated full
year 2023 non-cash financing expense related to the prepaid
obligation to RTW Investments in the range of $21.0 to $26.0
million. Of this amount approximately $9.9 to $11.2 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)
September 30, 2023
December 31, 2022
Cash and cash equivalents and marketable
securities
$
153,926
$
99,963
Total assets
$
193,633
$
135,619
Total liabilities
$
235,626
$
224,980
Total shareholders' deficit
$
(41,993
)
$
(89,361
)
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 September
30,
Nine months ended September
30,
2023
2022
2023
2022
Revenue
$
20,852
$
16,097
$
59,183
$
46,265
Cost of revenue
2,367
2,020
7,075
5,391
Gross profit
18,485
14,077
52,108
40,874
Operating expenses:
Research and development expenses
10,230
13,093
34,312
38,429
Selling, general and administrative
expenses
21,755
19,071
68,723
61,204
Total operating expenses
31,985
32,164
103,035
99,633
Operating loss
(13,500
)
(18,087
)
(50,927
)
(58,759
)
Financing on prepaid forward
obligation
(5,479
)
(4,819
)
(16,047
)
(16,478
)
Interest expense on long-term debt
(3,815
)
(2,694
)
(11,129
)
(5,215
)
Interest and other income, net
906
478
1,941
604
Loss before income taxes
$
(21,888
)
$
(25,122
)
$
(76,162
)
$
(79,848
)
Income tax expense
9
(709
)
(66
)
(1,066
)
Net loss
$
(21,879
)
$
(25,831
)
$
(76,228
)
$
(80,914
)
Statements of Comprehensive Loss
Net Loss
$
(21,879
)
$
(25,831
)
$
(76,228
)
$
(80,914
)
Other Comprehensive Income (Loss)
Unrealized gain (loss) on investments
20
(99
)
(27
)
(130
)
Comprehensive Loss
$
(21,859
)
$
(25,930
)
$
(76,255
)
$
(81,044
)
Net loss per ordinary share basic and
diluted
$
(0.68
)
$
(1.13
)
$
(2.89
)
$
(3.56
)
Weighted average shares outstanding, basic
and diluted
32,298,182
22,798,263
26,358,719
22,711,686
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 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
investigational drug formulation of mitomycin in Phase 3
development for the treatment of low-grade intermediate risk NMIBC.
Utilizing the RTGel® Technology Platform, UroGen’s proprietary
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. The
Company presented positive results from the ENVISION and ATLAS
Phase 3 trials with UGN-102 for the treatment of low-grade,
intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC)
in July 2023 and assuming positive secondary endpoint data from the
ENVISION study, is advancing a rolling NDA review anticipated to
commence in January 2024.
About the Phase 3 ENVISION Trial
The Phase 3 ENVISION trial is a single-arm, multinational,
multicenter study evaluating the efficacy and safety of UGN-102
(mitomycin) for intravesical solution as primary chemoablative
therapy in patients with low-grade, intermediate-risk NMIBC. The
Phase 3 ENVISION trial completed target enrollment with
approximately 240 patients across 56 sites. Study participants
received six once-weekly intravesical instillations of UGN-102. The
primary endpoint evaluated the complete response rate at the
3-month assessment after the first instillation, and the key
secondary endpoint will evaluate durability over time in patients
who achieved a complete response at the three-month assessment.
Based on discussions with the FDA, and assuming positive secondary
endpoint findings, UroGen anticipates submitting an NDA for UGN-102
in 2024. Learn more about the Phase 3 ENVISION trial at
www.clinicaltrials.gov (NCT05243550)
About the Phase 3 ATLAS Trial
ATLAS was a global, open-label, randomized controlled Phase 3
trial designed to assess the efficacy and safety of UGN-102, with
or without TURBT, vs. TURBT alone in patients diagnosed with
LG-IR-NMIBC. The trial enrolled 282 patients in clinical sites in
the U.S., Europe and Israel. Patients were randomized 1:1 to either
UGN-102 + / - TURBT or TURBT. Patients in the UGN-102 arm were
treated with six weekly intravesical instillations of UGN-102. At
the 3-month time point, patients were assessed for response.
Patients who demonstrated a complete response to either UGN-102 or
TURBT, were assessed for long-term follow-up for evidence of
recurrence. Patients who demonstrated presence of persistent
disease at 3-months, in either arm, underwent a TURBT and continued
for long-term follow-up for evidence of recurrence. The primary
endpoint of the study is disease-free survival. Learn more about
the ATLAS trial at www.clinicaltrials.gov (NCT04688931)
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 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. JELMYTO®
(mitomycin) for pyelocalyceal solution 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 Twitter,
@UroGenPharma.
Forward-Looking Statements
the Private Securities Litigation Reform Act of 1995, including,
without limitation, statements regarding: our plans for reporting
the secondary endpoint of duration of response data from ENVISION
and the timing thereof; the anticipated commencement of a rolling
NDA for UGN-102 in January 2024; the potential approval of UGN-102;
financial guidance for 2023; the potential of UroGen’s proprietary
RTGel technology to improve therapeutic profiles of existing drugs
and UroGen’s sustained release technology making local delivery
potentially more effective as compared to other treatment options.
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; there is no guarantee that the current clinical development
plan for UGN-102 will ultimately support submission of an NDA,
notwithstanding the current agreement with the FDA; the ability to
obtain regulatory approval within the timeframe expected, or at
all; 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) therefor
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; 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, 2023, filed with the SEC (available at http://www.sec.gov) on
August 10, 2023, as well as in the Risk Factors section of UroGen’s
Quarterly Report on Form 10-Q for the quarter ended September 30,
2023, 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.
JELMYTO®, RTGel® and UroGen® are registered trademarks of UroGen
Pharma Ltd.
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version on businesswire.com: https://www.businesswire.com/news/home/20231114806402/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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