Tarsus Pharmaceuticals, Inc. Reports Full-Year 2020 Financial Results and Business and Clinical Updates
March 31 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
year ended December 31, 2020.
“Since completing our successful IPO in October of last year, we
continue to make important clinical progress with our lead program,
TP-03, which is currently being evaluated in the Saturn-1 pivotal
Phase 2b/3 trial for Demodex blepharitis, a disease for which there
are currently no FDA-approved treatments,” said Bobak Azamian, MD,
PhD, CEO, Tarsus Pharmaceuticals, Inc. “Our recent strategic
partnership with LianBio for TP-03 in Greater China also expands
our global reach to the second largest healthcare market in the
world, while also providing significant non-dilutive funding. This
will further allow for our advancement of pipeline, including TP-04
and TP-05, each focused on areas of high unmet medical need in MGD,
rosacea, Lyme disease, and malaria.”
Recent Business Highlights and Corporate
Update:
- In March 2021, Tarsus announced its strategic partnership 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. In return, LianBio will (i) pay Tarsus $25 million by June
30, 2021 and up to $175 million in clinical, regulatory, and sales
milestones, (ii) pay Tarsus tiered low double-digit royalties on
sales of TP-03 in Greater China, and (iii) grant Tarsus a minority
equity stake in LianBio Ophthalmology.Tarsus expects to receive $70
million from these contractual milestones during the next 12
months.
- In December 2020, Tarsus had a Type C meeting with the United
States Food and Drug Administration (FDA) for TP-03 in the
treatment of Demodex blepharitis. This meeting confirmed the
planned new drug application (NDA) pathway with respect to the data
and information required in the NDA filing.
- In December 2020, Tarsus announced that it was added to the
broad-market Russell 3000® Index and the small-cap Russell 2000®
Index as part of its periodic rebalancing.
- Appointed Bryan Wahl, M.D., J.D. as General Counsel. Dr. Wahl
has over 15 years of broad legal experience, including significant
intellectual property (IP), corporate, and transactional
expertise.
- Appointed Dianne Whitfield as Chief Human Resources Officer.
Ms. Whitfield has more than 20 years of experience in human
resources, including over a decade of management and leadership
experience in the life sciences industry.
- Appointed Wendy L. Yarno to the Board of Directors and its
Audit Committee. Ms. Yarno has more than 30 years of experience in
the biopharmaceutical industry, both as a public company director
and product commercialization leader, including 26 years at Merck
& Co. Inc.Beginning in the fourth quarter of 2020, Tarsus
further expanded its management team and expertise of its Board of
Directors:
Full-Year 2020 Financial
Results:
- Full year net loss
for 2020 was $26.8 million, compared to $4.7 million in 2019.
- Full year research and development
expenses for 2020 were $18.8 million, compared to $3.2 million in
2019.
- Full year general and
administrative expenses for 2020 were $8.2 million, compared to
$1.1 million in 2019.
- As of December 31, 2020, cash and
cash equivalents were $168.1 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 in Phase
2b/3 that is being developed for the treatment of Demodex
blepharitis and 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 payments and achievement and
timing of milestones under the terms of the collaboration, the
ability of LianBio to commercialize TP-03 in the Greater China
territory, the market size for TP-03, future events and Tarsus’
plans for and the anticipated benefits of its product candidates
including TP-03, the timing, objectives and results of the clinical
studies and 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 or any other product candidate that
Tarsus develops receives marketing approval, Tarsus may not be
successful in educating eye care physician and the market about the
need for treatments specifically for Demodex blepharitis 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, 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
Tarsus’ product. 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: |
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SuJin Oh |
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Shop PR |
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(917) 841-5213 |
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soh@shop-pr.com |
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Investor
Contact: |
|
Patti Bank |
|
Westwicke Partners, an ICR
company |
|
(415) 513-1284 |
|
IR@tarsusrx.com |
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TARSUS PHARMACEUTICALS, INC.
STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS(In thousands, except share and
per share amounts)
|
Year Ended December 31, |
|
2020 |
|
2019 |
Operating
expenses: |
|
|
|
Research and development |
$ |
18,826 |
|
|
|
$ |
3,162 |
|
|
General and administrative |
8,172 |
|
|
|
1,136 |
|
|
Total operating expenses |
26,998 |
|
|
|
4,298 |
|
|
Loss from operations before
other income (expense) and income taxes |
(26,998 |
) |
|
|
(4,298 |
) |
|
Other income (expense): |
|
|
|
Interest income (expense), net |
188 |
|
|
|
(40 |
) |
|
Loss on extinguishment of convertible notes |
— |
|
|
|
(255 |
) |
|
Change in fair value of derivative liabilities |
— |
|
|
|
(76 |
) |
|
Total other income (expense) |
188 |
|
|
|
(371 |
) |
|
Provision for income
taxes |
(1 |
) |
|
|
(1 |
) |
|
Net loss and comprehensive
loss |
$ |
(26,811 |
) |
|
|
$ |
(4,670 |
) |
|
Net loss per share
attributable to common stockholders, basic and diluted |
$ |
(4.32 |
) |
|
|
$ |
(1.98 |
) |
|
Weighted-average shares
outstanding used in computing net loss per share attributable to
common stockholders, basic and diluted |
6,207,367 |
|
|
|
2,362,768 |
|
|
|
|
|
|
|
|
|
|
TARSUS PHARMACEUTICALS, INC.
BALANCE SHEETS(In
thousands, except share and par value amounts)
|
December 31, |
|
2020 |
|
2019 |
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
168,129 |
|
|
|
$ |
57,952 |
|
|
Restricted cash |
20 |
|
|
|
20 |
|
|
Other receivables |
20 |
|
|
|
36 |
|
|
Prepaid expenses |
2,486 |
|
|
|
22 |
|
|
Total current assets |
170,655 |
|
|
|
58,030 |
|
|
Property and equipment,
net |
548 |
|
|
|
154 |
|
|
Operating lease right-of-use
assets |
688 |
|
|
|
126 |
|
|
Other assets |
81 |
|
|
|
6 |
|
|
Total assets |
$ |
171,972 |
|
|
|
$ |
58,316 |
|
|
LIABILITIES, PREFERRED STOCK AND STOCKHOLDERS’ EQUITY
(DEFICIT) |
|
|
|
Current liabilities: |
|
|
|
Accounts payable and other accrued liabilities |
$ |
4,347 |
|
|
|
$ |
520 |
|
|
Accrued payroll and benefits |
1,040 |
|
|
|
299 |
|
|
Total current liabilities |
5,387 |
|
|
|
819 |
|
|
Other long-term
liabilities |
605 |
|
|
|
100 |
|
|
Total liabilities |
5,992 |
|
|
|
919 |
|
|
Commitments and contingencies |
|
|
|
Series A
Preferred Stock, $0.0001 par value; no shares authorized, issued
and outstanding at December 31, 2020; 1,575,030 shares authorized,
issued and outstanding at December 31, 2019; liquidation
preference of $3,650 at December 31, 2019 |
— |
|
|
|
3,564 |
|
|
Series B
Preferred Stock, $0.0001 par value; no shares authorized, issued
and outstanding at December 31, 2020; 6,731,649 shares authorized
and 6,674,909 shares issued and outstanding at December 31,
2019; liquidation preference of $60,010 at December 31,
2019 |
— |
|
|
|
59,838 |
|
|
Stockholders’ equity (deficit): |
|
|
|
Preferred stock, $0.0001 par value; 10,000,000 and no shares
authorized at December 31, 2020 and December 31, 2019,
respectively; no shares issued and outstanding at December 31, 2020
and December 31, 2019 |
— |
|
|
|
— |
|
|
Common
stock, $0.0001 par value; 200,000,000 shares authorized; 20,502,576
shares issued and 20,323,201 outstanding, which excludes 179,375
shares subject to repurchase at December 31, 2020; 2,650,919
shares issued and 2,646,619 outstanding, which excludes 4,300
shares subject to repurchase at December 31, 2019 |
4 |
|
|
|
2 |
|
|
Additional paid-in
capital |
198,821 |
|
|
|
27 |
|
|
Accumulated deficit |
(32,845 |
) |
|
|
(6,034 |
) |
|
Total stockholders’ equity (deficit) |
165,980 |
|
|
|
(6,005 |
) |
|
Total liabilities, preferred stock and stockholders’ equity
(deficit) |
$ |
171,972 |
|
|
|
$ |
58,316 |
|
|
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