Tarsus Pharmaceuticals, Inc. Reports First Quarter 2021 Financial Results and Provides Business and Clinical Updates
May 11 2021 - 4:05PM
Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS), a late clinical-stage
biopharmaceutical company 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 and certain business and clinical updates for the
quarter ended March 31, 2021.
“During the quarter, the company continued to execute on our
pipeline goals for our most advanced program, TP-03 in Demodex
blepharitis, as well as for our second asset, TP-05 for Lyme
disease prevention,” said Bobak Azamian, M.D., Ph.D., President and
Chief Executive Officer of Tarsus. “Initiating the second pivotal
Phase 3 trial for TP-03, Saturn-2, while planning for the topline
data read-out from Saturn-1, now expected this July, moves us
closer towards potential commercialization of a treatment for
Demodex blepharitis. We have increased confidence in the market
opportunity and need for a therapeutic option for the 25 million
Americans that may be affected by this common ocular disease with
no currently FDA-approved therapies.”
Recent Business Highlights and Corporate
Update:
- Announced commencement of Saturn-2 enrollment, Tarsus’ second
pivotal Phase 3 trial evaluating the company’s novel
investigational treatment, TP-03, in patients with Demodex
blepharitis. Up to 25 million Americans may be affected by Demodex
blepharitis, which is caused by an infestation of Demodex mites.
TP-03 is a topical ophthalmic formulation of lotilaner, a
well-characterized anti-parasitic agent designed to target and
eradicate Demodex mites. Tarsus also recently completed enrollment
for the Phase 2b/3 Saturn-1 pivotal trial, with 421 patients.
Topline results of the trial are expected to be announced this
July.
- Announced that the U.S. Food and Drug Administration (FDA) has
accepted the Company’s Investigational New Drug (IND) application
for TP-05, an oral, non-vaccine therapeutic for the prevention of
Lyme disease. With this IND acceptance, Tarsus plans to initiate a
Phase 1 single ascending dose and multiple ascending dose (SAD/MAD)
study to evaluate the safety, tolerability, and pharmacokinetics
(PK) of TP-05 in healthy volunteers. Study initiation is
anticipated in July.
- Presented data from its Atlas study at the virtual Association
for Research in Vision and Ophthalmology (ARVO) 2021 Annual
Meeting. The Atlas study is the first multi-center observational
study to evaluate the functional and psychosocial impact of Demodex
blepharitis, along with clinical manifestations, in adult patients.
Overall, the study showed that Demodex blepharitis is associated
with a significant symptomatic and psychosocial burden, negatively
affecting daily life in the majority (80%) of patients with the
disease.
- Also at ARVO, Tarsus presented the complete findings of the
Europa study, a prospective, randomized, vehicle-controlled Phase
2b trial that evaluated the safety and efficacy of twice-daily
TP-03, topical lotilaner ophthalmic solution 0.25%, in adult
patients with Demodex blepharitis. In the trial, TP-03 demonstrated
statistically significant results for the primary endpoint,
collarette cure over vehicle, which was achieved in 80% of patients
versus 16%, respectively, at 42 days (p<0.001) and the secondary
endpoint of mite eradication, which was achieved in 73% of patients
treated with TP-03 versus 21% of the vehicle group (p=0.003). There
were no serious adverse events and no discontinuations due to
adverse events.
- In March 2021, Tarsus announced its strategic partnership with
LianBio Ophthalmology Limited (LianBio) to develop and
commercialize TP-03 in Greater China (PRC, Hong Kong, Taiwan, and
Macau) for the treatment of Demodex blepharitis and Meibomian Gland
Disease (MGD), eye conditions with significant unmet treatment
needs. In this arrangement, LianBio obtained exclusive TP-03
development and commercialization rights to Greater China for the
treatment of Demodex blepharitis and MGD. As initial time-based
consideration, LianBio paid Tarsus $15 million in April 2021 and
$10 million in May 2021. LianBio remains contractually obligated
to: (i) pay Tarsus up to $175 million in clinical, regulatory, and
sales milestones upon achievement, (ii) pay Tarsus tiered low
double-digit royalties on its sales of TP-03 in Greater China, and
(iii) grant Tarsus equity warrants in LianBio, subject to vesting
provisions. Assuming Tarsus achieves remaining U.S. clinical
milestones for TP-03, as expected by March 2022, cumulative
proceeds from LianBio will total $70 million within the first 12
months following agreement execution.
First Quarter 2021 Financial Results
- First quarter net income for 2021 was $10.4 million, compared
to a net loss of $(2.0) million for the same period in 2020.
- First quarter 2021 license fee and collaboration revenue, as
part of strategic partnership with LianBio, was $33.4 million; and
$1.3 million in associated expense in proportion to this
revenue.
- First quarter research and development expenses for 2021 were
$16.3 million (inclusive of non-cash stock-based charges of $5.8
million), compared to $1.5 million for the same period in
2020.
- First quarter general and administrative expenses for 2021
increased to $5.2 million (inclusive of non-cash stock-based
charges of $1.0 million), compared to $0.6 million for the same
period in 2020.
- As of March 31, 2021, cash and cash equivalents were $156.2
million.
About Tarsus Pharmaceuticals,
Inc.Tarsus Pharmaceuticals, Inc. is a late clinical-stage
biopharmaceutical company that applies proven science and new
technology to revolutionize treatment for patients, starting with
eye care. It 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.
Its lead product candidate, TP-03, is a novel therapeutic being
studied in two pivotal trials for the treatment of Demodex
blepharitis. TP-03 is also being developed for the treatment of
Meibomian Gland Disease.
Forward-Looking
StatementsStatements 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 receipt by Tarsus of future payments and achievement
and timing of milestones under the terms of the collaboration with
LianBio, the ability of LianBio to commercialize TP-03 in the
Greater China territory, the market size for TP-03 and TP-05,
future events and Tarsus’ plans for and the anticipated benefits of
its product candidates including TP-03 and TP-05, the timing,
objectives and results of the clinical studies, anticipated
regulatory and development milestones 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 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 any commercialization of its product
candidates, if approved; Tarsus is heavily dependent on the success
of its lead product candidate, TP-03 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-05, or any other product candidate
that Tarsus develops receives marketing approval, Tarsus may not be
successful in educating eye care physicians and the market about
the need for treatments specifically for Demodex blepharitis, Lyme
disease, 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 TP-03 for
the treatment of Demodex blepharitis and MGD, as well as TP-05 for
the treatment 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; and 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. 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, 2020 filed with the SEC on March 31, 2021, 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: |
|
SuJin Oh |
|
Shop PR |
|
(917) 841-5213 |
|
sujin@shop-pr.com |
|
|
|
Investor
Contact: |
|
Patti Bank |
|
Westwicke Partners, an ICR
company |
|
(415) 513-1284 |
|
IR@tarsusrx.com |
|
TARSUS PHARMACEUTICALS, INC.
STATEMENTS OF OPERATIONS AND
COMPREHENSIVE INCOME (LOSS)(In thousands, except
share and per share amounts)
|
Three Months EndedMarch 31, |
|
2021 |
|
2020 |
Revenues: |
|
|
|
License fees |
$ |
33,311 |
|
|
$ |
— |
|
Collaboration revenue |
121 |
|
|
— |
|
Total revenues |
33,432 |
|
|
— |
|
Operating expenses: |
|
|
|
Cost of license fees and collaboration revenue |
1,297 |
|
|
— |
|
Research and development |
16,261 |
|
|
1,512 |
|
General and administrative |
5,160 |
|
|
606 |
|
Total operating expenses |
22,718 |
|
|
2,118 |
|
Income
(loss) from operations before other (expense) income and income
taxes |
10,714 |
|
|
(2,118 |
) |
Other
(expense) income: |
|
|
|
Interest income (expense), net |
9 |
|
|
161 |
|
Other (expense) income, net |
(34 |
) |
|
— |
|
Total other (expense) income |
(25 |
) |
|
161 |
|
Provision for income taxes |
(313 |
) |
|
— |
|
Net
income (loss) and comprehensive income (loss) |
$ |
10,376 |
|
|
$ |
(1,957 |
) |
Net
income (loss) per share |
|
|
|
Basic |
$ |
0.51 |
|
|
$ |
(0.74 |
) |
Diluted |
$ |
0.47 |
|
|
$ |
(0.74 |
) |
Weighted-average shares outstanding |
|
|
|
Basic |
20,336,022 |
|
|
2,650,363 |
|
Diluted |
21,824,574 |
|
|
2,650,363 |
|
TARSUS PHARMACEUTICALS, INC.
BALANCE SHEETS(In
thousands, except share and par value amounts)
|
March 31, 2021 |
|
December 31, 2020 |
|
(unaudited) |
|
|
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
156,179 |
|
|
$ |
168,129 |
|
Restricted cash |
20 |
|
|
20 |
|
Accounts
receivable |
25,000 |
|
|
— |
|
Contract
asset |
7,199 |
|
|
— |
|
Other
receivables |
247 |
|
|
20 |
|
Prepaid
expenses and other current assets |
2,806 |
|
|
2,486 |
|
Total current assets |
191,451 |
|
|
170,655 |
|
Property and equipment, net of
accumulated depreciation |
589 |
|
|
548 |
|
Operating lease right-of-use
asset |
584 |
|
|
688 |
|
Other assets |
1,330 |
|
|
81 |
|
Total assets |
$ |
193,954 |
|
|
$ |
171,972 |
|
LIABILITIES, PREFERRED STOCK AND STOCKHOLDERS’
EQUITY |
|
|
|
Current liabilities: |
|
|
|
Accounts payable and other
accrued liabilities |
$ |
9,433 |
|
|
$ |
4,347 |
|
Accrued payroll and
benefits |
685 |
|
|
1,040 |
|
Total current liabilities |
10,118 |
|
|
5,387 |
|
Other long-term
liabilities |
604 |
|
|
605 |
|
Total liabilities |
10,722 |
|
|
5,992 |
|
Commitments and contingencies (Note 9) |
|
|
|
Stockholders’ equity: |
|
|
|
Preferred stock, $0.0001 par value; 10,000,000 authorized at
March 31, 2021 andDecember 31, 2020; no shares issued and
outstanding at March 31, 2021 andDecember 31, 2020 |
— |
|
|
— |
|
Common
stock, $0.0001 par value; 200,000,000 shares authorized; 20,703,849
sharesissued and 20,524,474 outstanding, which excludes 179,375
shares subject torepurchase at March 31, 2021 (unaudited);
20,502,576 shares issued and 20,323,301outstanding, which excludes
179,375 shares subject to repurchase at December 31, 2020 |
4 |
|
|
4 |
|
Additional paid-in
capital |
205,697 |
|
|
198,821 |
|
Accumulated deficit |
(22,469 |
) |
|
(32,845 |
) |
Total stockholders’ equity |
183,232 |
|
|
165,980 |
|
Total liabilities, preferred stock and stockholders’
equity |
$ |
193,954 |
|
|
$ |
171,972 |
|
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