Tarsus Reports First Quarter 2022 Financial Results and Recent Business Achievements
May 10 2022 - 4:05PM
Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS), whose mission is to
focus on unmet needs and apply proven science and new technology to
revolutionize treatment for eye diseases, today announced financial
results for the first quarter ended March 31, 2022, and recent
business achievements.
“In the first quarter, we took important steps towards becoming
a leading eye care pharmaceutical company. We reported strong and
consistent Saturn-2 data, further validating the safety and
efficacy of TP-03 and positioning it as the definitive standard of
care for millions of patients who suffer from Demodex blepharitis,”
said Bobak Azamian, M.D., Ph.D., President and Chief Executive
Officer of Tarsus. “We also further strengthened our balance sheet
by completing a $76 million public offering earlier this month.
These proceeds, along with our other cash resources and expected
commercialization of TP-03, are anticipated to bridge our company
into profitability.”
Recent Business Highlights and Corporate
Update
- TP-03 met the primary and all secondary endpoints, resolved
Demodex blepharitis (DB) and was safe and well-tolerated in
Saturn-2 Phase 3, the second and final pivotal trial
- Primary endpoint: Demodex complete collarette cure was achieved
by 56% of patients on TP-03, compared to 13% on vehicle
(p<0.0001) on day 43
- Additionally, 89% of patients achieved a significant,
clinically meaningful collarette cure compared to 33% of those on
vehicle (p<0.0001)
- Secondary endpoints:
- Mite eradication was achieved by 52% of patients on TP-03,
compared to 14% on vehicle (p<0.0001) on day 43
- Complete lid erythema (redness) cure in 31.1% of patients on
TP-03, compared to 9.0% of patients on vehicle (p<0.0001) on day
43
- Complete composite cure in 19.2% of patients on TP-03, based on
achieving both collarette cure and erythema cure, compared to 4.0%
on vehicle (p<0.0001) on day 43
- Safety Profile: TP-03 was well-tolerated with no serious
treatment-related adverse events and a safety profile similar to
Saturn-1
- Presented data from Atlas Continuation and Pandora studies at
multiple medical meetings demonstrating the negative impact and
clinical burden of DB on patients
- Atlas Continuation Study: consistent results with original
Atlas study showing nearly 80% of DB patients reporting a negative
impact on daily life
- Pandora preliminary findings show that DB patients have more
bacterial strains on their eyelids which can lead to sub-optimal
outcomes for surgical patients and contact lens users
- Advanced TP-05, a novel, oral, non-vaccine potential
therapeutic for the prevention of Lyme disease, in the Callisto
Phase 1b trial, with data expected in the second half of 2022
- Callisto is a single and multiple ascending dose trial to
evaluate safety, tolerability and pharmacokinetics of TP-05 in
healthy volunteers
- There are approximately 80 million people in the U.S. at risk
for Lyme disease exposure, more than 30 million of which are at
moderate-to-high risk, which can result in severe neurological and
other debilitating symptoms
- Cash runway expected into at least 2026
- $175 million of cash as of March 31, 2022, and $71 million net
follow-on equity raise completed in May 2022
- $30 million in expected milestones in 2022 and $15 million
expected in 2024 from China out-license
- $80 million of credit facility availability through the
potential FDA approval of TP-03, $50 million upon achievement of
certain quarterly revenue thresholds and $25 million available with
lender approval
Anticipated 2022 Milestones
Program |
Milestone |
Anticipated Indication |
H1 2022 |
H2 2022 |
TP-03 |
Topline Pivotal Data (Saturn-2) |
Demodex blepharitis |
✓ |
|
TP-03 |
Initiate Phase 2 (Ersa) |
Meibomian Gland Disease |
● |
|
TP-05 |
Initiate Ph2a |
Lyme disease prevention |
● |
|
TP-03 |
NDA Submission |
Demodex blepharitis |
|
● |
TP-04 |
Initiate Phase 2 (Galatea) |
Rosacea |
|
● |
TP-05 |
Phase 1b Data (Callisto) |
Lyme disease prevention |
|
● |
TP-03 |
Initiate Phase 3 trial in China |
Demodex blepharitis |
|
● |
First Quarter 2022 Financial Results
- First quarter net loss for 2022 was $20.2 million, compared to
net income of $10.4 million for the same period in 2021
- First quarter 2022 license fee and collaboration revenue, as
part of the strategic partnership with LianBio, was $0.5 million,
compared to $33.4 million for the same period in 2021
- First quarter research and development expenses for 2022 were
$12.1 million (inclusive of stock-based compensation of $0.7
million), compared to $16.3 million for the same period in
2021
- First quarter general and administrative expenses for 2022 were
$7.9 million (inclusive of stock-based compensation of $2.0
million), compared to $5.2 million for the same period in 2021
- As of March 31, 2022, cash, cash equivalents and
marketable securities were $175.3 million
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. Tarsus is studying two investigational medicines in
clinical trials. Its lead product candidate, TP-03, is a novel
therapeutic which has demonstrated positive results in two pivotal
trials for the treatment of Demodex blepharitis. TP-03 is also
being developed for the treatment of Meibomian Gland Disease. In
addition, Tarsus is developing TP-05, an oral, non-vaccine
therapeutic for the prevention of Lyme disease, which is currently
being studied in a Phase 1b clinical trial.
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 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, TP-04 and TP-05, the
timing, objectives and results of the clinical trials, 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 healthcare professionals 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, 2021 filed on March 14, 2022 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) INCOME (In thousands, except
share and per share
amounts)(unaudited)
|
Three Months EndedMarch 31, |
|
|
2022 |
|
|
|
2021 |
|
Revenues: |
|
|
|
License fees |
$ |
— |
|
|
$ |
33,311 |
|
Collaboration revenue |
|
539 |
|
|
|
121 |
|
Total revenues |
|
539 |
|
|
|
33,432 |
|
Operating
expenses: |
|
|
|
Cost of license fees and collaboration revenue |
|
33 |
|
|
|
1,297 |
|
Research and development |
|
12,081 |
|
|
|
16,261 |
|
General and administrative |
|
7,946 |
|
|
|
5,160 |
|
Total operating expenses |
|
20,060 |
|
|
|
22,718 |
|
(Loss) income from operations
before other (expense) income and income taxes |
|
(19,521 |
) |
|
|
10,714 |
|
Other (expense) income: |
|
|
|
Interest (expense) income |
|
(316 |
) |
|
|
9 |
|
Other income (expense), net |
|
37 |
|
|
|
(34 |
) |
Unrealized loss on equity securities |
|
(192 |
) |
|
|
— |
|
Change in fair value of equity warrants |
|
(245 |
) |
|
|
— |
|
Total other expense, net |
|
(716 |
) |
|
|
(25 |
) |
Provision (benefit) for income
taxes |
|
(1 |
) |
|
|
(313 |
) |
Net (loss) income and
comprehensive (loss) income |
$ |
(20,238 |
) |
|
$ |
10,376 |
|
|
|
|
|
Net (loss) income per share,
basic |
$ |
(0.98 |
) |
|
$ |
(0.51 |
) |
Net (loss) income per share,
diluted |
$ |
(0.98 |
) |
|
$ |
0.47 |
|
|
|
|
|
Weighted-average shares
outstanding, basic |
|
20,710,224 |
|
|
|
20,336,022 |
|
Weighted-average shares
outstanding, diluted |
|
20,710,224 |
|
|
|
21,824,574 |
|
TARSUS PHARMACEUTICALS, INC.
BALANCE SHEETS(In
thousands, except share and par value amounts)
|
March 31, 2022 |
|
December 31, 2021 |
|
(unaudited) |
|
|
ASSETS |
|
|
|
Current
assets: |
|
|
|
Cash and cash equivalents |
$ |
175,010 |
|
|
$ |
171,332 |
|
Marketable securities |
|
291 |
|
|
|
483 |
|
Other receivables |
|
306 |
|
|
|
92 |
|
Prepaid expenses and other
current assets |
|
3,131 |
|
|
|
4,045 |
|
Total current assets |
|
178,755 |
|
|
|
175,952 |
|
Property and equipment,
net |
|
915 |
|
|
|
755 |
|
Operating lease right-of-use
assets |
|
926 |
|
|
|
1,074 |
|
Other assets |
|
887 |
|
|
|
1,126 |
|
Total
assets |
$ |
181,483 |
|
|
$ |
178,907 |
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
|
|
Current
liabilities: |
|
|
|
Accounts payable and other
accrued liabilities |
$ |
10,805 |
|
|
$ |
8,680 |
|
Accrued payroll and
benefits |
|
1,805 |
|
|
|
2,798 |
|
Total current liabilities |
|
12,610 |
|
|
|
11,478 |
|
Debt |
|
19,180 |
|
|
|
— |
|
Other long-term
liabilities |
|
496 |
|
|
|
699 |
|
Total
liabilities |
|
32,286 |
|
|
|
12,177 |
|
Commitments and
contingencies (Note
8) |
|
|
|
Stockholders’
equity: |
|
|
|
Preferred stock, $0.0001 par
value; 10,000,000 authorized; no shares issued and outstanding at
March 31, 2022 and December 31, 2021 |
|
— |
|
|
|
— |
|
Common stock, $0.0001 par value;
200,000,000 shares authorized; 20,731,062 shares issued and
20,718,528 outstanding, which excludes 12,534 shares subject to
repurchase at March 31, 2022 (unaudited); 20,726,580 shares
issued and 20,698,737 outstanding, which excludes 27,840 shares
subject to repurchase at December 31, 2021 |
|
4 |
|
|
|
4 |
|
Additional paid-in
capital |
|
216,103 |
|
|
|
213,398 |
|
Accumulated deficit |
|
(66,910 |
) |
|
|
(46,672 |
) |
Total stockholders’
equity |
|
149,197 |
|
|
|
166,730 |
|
Total liabilities and
stockholders’ equity |
$ |
181,483 |
|
|
$ |
178,907 |
|
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