Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS), whose mission is to
focus on unmet needs and apply proven science and new technology to
revolutionize treatment for patients, starting with eye care, today
announced financial results for the second quarter ended
June 30, 2023, and recent business achievements.
“The FDA approval of XDEMVY for the treatment of Demodex
blepharitis is a seminal milestone for Tarsus, the eye care
community and most importantly for patients, many of whom have
struggled for years without an approved, effective treatment
option,” said Bobak Azamian, MD, PhD, Chief Executive Officer and
Chairman of Tarsus. “We are well-positioned and well-funded, expect
to launch XDEMVY later this month to capture the potentially very
significant patient demand, and anticipate rapid adoption among eye
care providers and meaningful prescription volume in the early days
following XDEMVY’s entrance into the market.”
Recent Business Highlights and Corporate
Update
- On July 24, 2023, the FDA approved XDEMVY (lotilaner ophthalmic
solution) 0.25% for the treatment of Demodex blepharitis (DB)
- First and only approved therapeutic for DB, a highly prevalent
eyelid disease that impacts approximately 25 million eye care
patients in the U.S.
- XDEMVY targets the root cause of DB and in pivotal trials
demonstrated significant improvement in eyelids (reduction of
collarettes, the pathognomonic sign of the disease, to no more than
2 collarettes per upper lid), mite eradication (mite density of 0
mites per lash) and erythema cure (Grade 0)
- Actively engaging in contracting discussions with all the top
commercial and Medicare accounts and expect to secure commercial
coverage sequentially throughout 2024 and Medicare coverage in
2025
- Completed recruitment of our 85-person sales force targeting
~15K optometrists and ophthalmologists, which represents >80% of
the projected market; expect sales force to be deployed by the end
of August when we anticipate product to be available
- Established unique distribution model leveraging high touch
retail and digital pharmacies to offer broad patient access with a
potential 2x fill rate compared to traditional approaches
- Active disease education continuing to drive awareness and
encouraging eye care providers (ECPs) to proactively diagnose DB
- Consistently > 90% of ~250 optometrists and ophthalmologists
surveyed indicated they would prescribe an FDA-approved therapeutic
for DB
- “Look at the Lids” disease education campaign has generated
nearly 300K unique website visits, up from 200K last quarter and
nearly 3M digital/media impressions, an increase of 700K
impressions since last quarter
- Saturn-2 pivotal trial results were published in the American
Academy of Ophthalmology journal
- XDEMVY met the primary, all secondary endpoints and was
generally well tolerated
Achieved and Anticipated 2023 Milestones
Program |
Milestone |
Anticipated Indication |
H1 2023 |
H2 2023 |
TP-04 |
Initiated Phase 2a (Galatea) |
Rosacea |
X |
|
XDEMVY |
FDA Approval |
Demodex blepharitis |
|
X |
TP-03 |
Topline Phase 2a (Ersa) |
Meibomian Gland Disease |
|
● |
TP-05 |
Topline Phase 2a (Carpo) |
Lyme disease prevention |
|
● |
Second Quarter 2023 Financial Results
- Second quarter net loss for 2023 was $31.4 million, compared to
a net loss of $5.7 million for the same period in 2022, which was
primarily due to: (i) a decrease of $15.3 million of license fee
and collaboration revenue, (ii) an increase of $9.9 million of
general and administrative expenses, and (iii) an increase of $2.9
million of research and development expenses
- Second quarter 2023 there were no amounts reported within
license fee and collaboration revenue related to the strategic
partnership with LianBio, compared to $15.3 million for the same
period in 2022
- Second quarter research and development expenses for 2023 were
$12.5 million (inclusive of stock-based compensation of $1.5
million), compared to $9.6 million for the same period in 2022
- Second quarter general and administrative expenses for 2023
were $20.3 million (inclusive of stock-based compensation of $3.7
million), compared to $10.4 million for the same period in 2022,
which was primarily due to a $5.3 million increase of payroll and
personnel-related costs; and a $3.5 million increase of commercial
and market research costs related to our commercial expansion as we
prepare to launch our recently approved product, XDEMVY
- As of June 30, 2023, cash, cash equivalents and marketable
securities were $178.2 million, not including the recent equity
public offering of $100 million in gross proceeds, completed in
August 2023
About Demodex
BlepharitisBlepharitis is a common lid margin
disease that is characterized by eyelid margin inflammation,
redness and ocular irritation. Demodex blepharitis is caused by an
infestation of Demodex mites, the most common ectoparasite found on
humans and accounts for over two-thirds of all blepharitis cases.
Demodex blepharitis may affect as many as 25 million Americans
based on an extrapolation from the Titan study indicating 58% of
patients presenting to U.S. eye care clinics have collarettes, a
pathognomonic sign of Demodex infestation, and that at least 45
million people annually visit an eye care clinic. Demodex
blepharitis can have a significant clinical burden and negative
impact on patients’ daily lives. The Titan study also showed that
current management tools, such as tea tree oil and lid wipes, are
ineffective at targeting the root cause of Demodex blepharitis.
About XDEMVY™XDEMVY (lotilaner ophthalmic
solution) 0.25%, formerly known as TP-03, is a novel prescription
eye drop designed to treat Demodex blepharitis by targeting and
eradicating the root cause of the disease – Demodex mite
infestation. XDEMVY was evaluated in two pivotal trials
collectively involving more than 800 patients. Both trials met the
primary endpoint and all secondary endpoints, with statistical
significance and no serious treatment-related adverse events. Most
patients found the XDEMVY eye drop to be neutral to very
comfortable. The most common ocular adverse reactions observed in
the studies were instillation site stinging and burning which was
reported in 10% of patients. Other ocular adverse reactions
reported by less than 2% of patients were chalazion/hordeolum
(stye) and punctate keratitis.
XDEMVY Indication and Important Safety
Information
INDICATIONS AND USAGEXDEMVY is indicated for
the treatment of Demodex blepharitis.
Most common side effects: The most common side
effect in clinical trials was stinging and burning in 10% of
patients. Other side effects in less than 2% of patients were
chalazion/hordeolum and punctate keratitis.
For additional information, please see full prescribing
information available at: www.xdemvy.com.
About Tarsus Pharmaceuticals,
Inc.
Tarsus Pharmaceuticals, Inc. applies proven science and new
technology to revolutionize treatment for patients, starting with
eye care. Tarsus is advancing its pipeline to address several
diseases with high unmet need across a range of therapeutic
categories, including eye care, dermatology, and infectious disease
prevention. XDEMVY (lotilaner ophthalmic solution) 0.25% is FDA
approved in the United States for the treatment of Demodex
blepharitis. Tarsus is also developing TP-03 for the treatment of
Meibomian Gland Disease, which is currently being studied in a
Phase 2a clinical trial. In addition, Tarsus is developing TP-04
for the potential treatment of Rosacea and TP-05, an oral tablet
for the prevention of Lyme disease. TP-04 and TP-05 are both
currently being studied in Phase 2a clinical trials to evaluate
safety, tolerability, and proof-of activity.
Forward-Looking Statements
Statements in this press release about future expectations,
plans and prospects, as well as any other statements regarding
matters that are not historical facts, may constitute
“forward-looking statements.” These statements include statements
regarding the timing and availability of XDEMVY for prescription,
the market size, acceptance, demand, prescription fill rate and
adoption rate for XDEMVY; our ability to achieve distribution and
patient access for XDEMVY and timing and breadth of payer coverage;
our sales force size and hiring plans; our ability to continue to
educate the market about Demodex blepharitis, the market size for
TP-03, TP-04, and TP-05, the timing, objectives, and results of the
clinical trials, anticipated regulatory and development milestones,
our ability to continue investing in our business, future events
and Tarsus’ plans for and the anticipated benefits of its product
candidates including TP-03, TP-04 and TP-05, and the quotations of
Tarsus’ management. The words, without limitation, “believe,”
“contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,”
“may,” “might,” “plan,” “potential,” “predict,” “project,”
“should,” “target,” “will,” or “would,” or the negative of these
terms or other similar expressions are intended to identify
forward-looking statements, although not all forward-looking
statements contain these or similar identifying words. Actual
results may differ materially from those indicated by such forward-
looking statements as a result of various important factors.
Important factors that could cause actual results to differ
materially from those in the forward-looking statements include:
Tarsus’ ability to maintain regulatory approval for and
successfully commercialize XDEMVY for the treatment of Demodex
blepharitis, Tarsus has incurred significant losses and negative
cash flows from operations since inception and anticipates that it
will continue to incur significant expenses and losses for the
foreseeable future; Tarsus may need to obtain additional funding to
complete the development and commercialization of its product
candidates, if approved; Tarsus is heavily dependent on the success
of its lead product, XDEMVY for the treatment of Demodex
blepharitis; the COVID-19 pandemic may affect Tarsus’ ability to
initiate and complete preclinical studies and clinical trials,
disrupt regulatory activities, disrupt manufacturing and supply
chain or have other adverse effects on Tarsus’ business and
operations; even if TP-03, TP-04, TP-05, or any other product
candidate that Tarsus develops receives marketing approval, Tarsus
may not be successful in educating healthcare professionals and the
market about the need for treatments specifically for Demodex
blepharitis, MGD, rosacea, Lyme disease prevention, and/or other
diseases or conditions targeted by Tarsus’ products; the
development and commercialization of Tarsus products is dependent
on intellectual property it licenses from Elanco Tiergesundheit AG;
Tarsus will need to develop and expand the company and Tarsus may
encounter difficulties in managing its growth, which could disrupt
its operations; the sizes of the market opportunity for Tarsus’
product candidates, particularly XDEMVY for the treatment of
Demodex blepharitis, TP-03 for the treatment of MGD, TP-04 for the
treatment of Rosacea, as well as TP-05 for the prevention of Lyme
disease, have not been established with precision and may be
smaller than estimated; the results of Tarsus’ earlier studies and
trials may not be predictive of future results; any termination or
suspension of, or delays in the commencement or completion of,
Tarsus’ planned clinical trials could result in increased costs,
delay or limit its ability to generate revenue and adversely affect
its commercial prospects; if Tarsus is unable to obtain and
maintain sufficient intellectual property protection for its
product candidates, or if the scope of the intellectual property
protection is not sufficiently broad, Tarsus’ competitors could
develop and commercialize products similar or identical to Tarsus’
products; and if Tarsus is unable to access capital (including but
not limited to cash, cash equivalents, and credit facilities)
and/or loses capital, as a result of potential failure of any
financial institutions that Tarsus does business with directly or
indirectly. Further, there are other risks and uncertainties that
could cause actual results to differ from those set forth in the
forward-looking statement and they are detailed from time to time
in the reports Tarsus files with the Securities and Exchange
Commission, including Tarsus’ Form 10-K for the year ended
December 31, 2022 filed on March 17, 2023 and the most
recent Form 10-Q quarterly filing filed with the SEC, which Tarsus
incorporates by reference into this press release, copies of which
are posted on its website and are available from Tarsus without
charge. However, new risk factors and uncertainties may emerge from
time to time, and it is not possible to predict all risk factors
and uncertainties. Accordingly, readers are cautioned not to place
undue reliance on these forward-looking statements. Any
forward-looking statements contained in this press release are
based on the current expectations of Tarsus’ management team and
speak only as of the date hereof, and Tarsus specifically disclaims
any obligation to update any forward-looking statement, whether as
a result of new information, future events or otherwise.
Media
Contact: |
|
Adrienne Kemp |
|
Sr. Director, Corporate
Communications |
|
(949) 922-0801 |
|
AKemp@tarsusrx.com |
|
|
|
Investor
Contact: |
|
David Nakasone |
|
Head of Investor
Relations |
|
(949) 620-3223 |
|
DNakasone@tarsusrx.com |
|
|
|
TARSUS PHARMACEUTICALS, INC.
STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS(In thousands, except share and
per share amounts)(unaudited)
|
Three Months EndedJune 30, |
|
Six Months EndedJune 30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Revenues: |
|
|
|
|
|
|
|
License fees and collaboration revenue |
$ |
— |
|
|
$ |
15,277 |
|
|
$ |
2,500 |
|
|
$ |
15,816 |
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
Cost of license fees and collaboration revenue |
|
— |
|
|
|
522 |
|
|
|
— |
|
|
|
555 |
|
Research and development |
|
12,546 |
|
|
|
9,603 |
|
|
|
24,902 |
|
|
|
21,684 |
|
General and administrative |
|
20,275 |
|
|
|
10,376 |
|
|
|
35,371 |
|
|
|
18,322 |
|
Total operating expenses |
|
32,821 |
|
|
|
20,501 |
|
|
|
60,273 |
|
|
|
40,561 |
|
Loss from operations before other
income (expense) and income taxes |
|
(32,821 |
) |
|
|
(5,224 |
) |
|
|
(57,773 |
) |
|
|
(24,745 |
) |
Other income (expense): |
|
|
|
|
|
|
|
Interest income |
|
2,226 |
|
|
|
297 |
|
|
|
4,519 |
|
|
|
311 |
|
Interest expense |
|
(815 |
) |
|
|
(544 |
) |
|
|
(1,499 |
) |
|
|
(874 |
) |
Other (expense) income, net |
|
(47 |
) |
|
|
106 |
|
|
|
(41 |
) |
|
|
143 |
|
Unrealized gain (loss) on equity investments |
|
15 |
|
|
|
(121 |
) |
|
|
(50 |
) |
|
|
(313 |
) |
Change in fair value of equity warrants issued by licensee |
|
18 |
|
|
|
(257 |
) |
|
|
1 |
|
|
|
(502 |
) |
Total other income (expense), net |
|
1,397 |
|
|
|
(519 |
) |
|
|
2,930 |
|
|
|
(1,235 |
) |
Provision for income taxes |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(1 |
) |
Net loss |
$ |
(31,424 |
) |
|
$ |
(5,743 |
) |
|
$ |
(54,843 |
) |
|
$ |
(25,981 |
) |
|
|
|
|
|
|
|
|
Other comprehensive loss: |
|
|
|
|
|
|
|
Unrealized gain on marketable
securities and cash equivalents |
|
47 |
|
|
|
— |
|
|
|
51 |
|
|
|
— |
|
Comprehensive loss |
$ |
(31,377 |
) |
|
$ |
(5,743 |
) |
|
$ |
(54,792 |
) |
|
$ |
(25,981 |
) |
|
|
|
|
|
|
|
|
Net loss per share, basic |
$ |
(1.17 |
) |
|
$ |
(0.24 |
) |
|
$ |
(2.05 |
) |
|
$ |
(1.15 |
) |
Net loss per share, diluted |
$ |
(1.17 |
) |
|
$ |
(0.24 |
) |
|
$ |
(2.05 |
) |
|
$ |
(1.15 |
) |
|
|
|
|
|
|
|
|
Weighted-average shares
outstanding, basic |
|
26,815,733 |
|
|
|
24,332,531 |
|
|
|
26,779,203 |
|
|
|
22,531,384 |
|
Weighted-average shares
outstanding, diluted |
|
26,815,733 |
|
|
|
24,332,531 |
|
|
|
26,779,203 |
|
|
|
22,531,384 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TARSUS PHARMACEUTICALS, INC.
BALANCE SHEETS(In
thousands, except share and par value amounts)
|
|
|
June 30, 2023 |
|
December 31, 2022 |
|
(unaudited) |
|
|
ASSETS |
|
|
|
Current
assets: |
|
|
|
Cash and cash equivalents |
$ |
106,773 |
|
|
$ |
71,660 |
|
Marketable securities |
|
71,455 |
|
|
|
145,366 |
|
Other receivables |
|
246 |
|
|
|
3,582 |
|
Prepaid expenses |
|
5,002 |
|
|
|
4,767 |
|
Total current assets |
|
183,476 |
|
|
|
225,375 |
|
Property and equipment,
net |
|
1,541 |
|
|
|
957 |
|
Operating lease right-of-use
assets |
|
2,137 |
|
|
|
575 |
|
Long-term investments |
|
322 |
|
|
|
371 |
|
Other assets |
|
1,451 |
|
|
|
585 |
|
Total
assets |
$ |
188,927 |
|
|
$ |
227,863 |
|
LIABILITIES AND
STOCKHOLDERS' EQUITY |
|
|
|
Current
liabilities: |
|
|
|
Accounts payable and other
accrued liabilities |
$ |
9,459 |
|
|
$ |
9,910 |
|
Accrued payroll and
benefits |
|
5,306 |
|
|
|
5,519 |
|
Total current liabilities |
|
14,765 |
|
|
|
15,429 |
|
Term loan, net |
|
24,607 |
|
|
|
19,434 |
|
Other long-term
liabilities |
|
1,826 |
|
|
|
100 |
|
Total
liabilities |
|
41,198 |
|
|
|
34,963 |
|
Commitments and
contingencies |
|
|
|
Stockholders’
equity: |
|
|
|
Preferred stock, $0.0001 par
value; 10,000,000 authorized; no shares issued and outstanding |
|
— |
|
|
|
— |
|
Common stock, $0.0001 par value;
200,000,000 shares authorized; 26,899,572 shares issued and
outstanding at June 30, 2023 (unaudited); 26,727,458 shares
issued and outstanding at December 31, 2022 |
|
5 |
|
|
|
5 |
|
Additional paid-in
capital |
|
311,353 |
|
|
|
301,732 |
|
Accumulated other comprehensive
loss |
|
(23 |
) |
|
|
(74 |
) |
Accumulated deficit |
|
(163,606 |
) |
|
|
(108,763 |
) |
Total stockholders’
equity |
|
147,729 |
|
|
|
192,900 |
|
Total liabilities and
stockholders’ equity |
$ |
188,927 |
|
|
$ |
227,863 |
|
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