Iterum Therapeutics plc (Nasdaq: ITRM), a clinical-stage
pharmaceutical company focused on developing next generation oral
and IV antibiotics to treat infections caused by multi-drug
resistant pathogens in both community and hospital settings, today
reported financial results for the fourth quarter and year ended
December 31, 2021.
“Based on several recent interactions with the FDA, we believe
that we have made progress towards an agreement on the additional
Phase 3 trial design required to support the resubmission of our
NDA for oral sulopenem in uUTI. Subject to finalization of the
clinical program, we expect to start the study in the second half
of 2022,” said Corey Fishman, Iterum’s Chief Executive Officer.
“Based on the current operating plan, which includes an additional
Phase 3 study, we believe that we are well positioned financially
to fund operations into 2024 with our existing cash resources.”
Highlights and Recent Events
- Reduced outstanding
debt: We completed the repayment of our term loan with
Silicon Valley Bank in March 2022.
- Received 180-day extension
of Nasdaq listing deficiency: On March 9, 2022, we
received written notification from Nasdaq that a 180-day extension
to regain compliance with Nasdaq's minimum bid price requirement
was granted. We now have until September 5, 2022 to meet this
requirement.
- Published two articles in
scientific journals: In February 2022, we published two
articles highlighting anti-bacterial resistance and the unmet
medical need for new oral agents for urinary tract infections. The
articles can be accessed under “Scientific Publications” in the Our
Science section of the Company’s website at www.iterumtx.com.
Fourth Quarter and Full Year 2021 Financial
Results
Cash, cash equivalents and short-term investments was $81.3
million at December 31, 2021. Based on the current operating plan
and subject to final determination of the design and planned
conduct of potential additional clinical and non-clinical
development of sulopenem, Iterum expects that its current cash,
cash equivalents and short-term investments will be sufficient to
fund its operations into 2024. As of February 28, 2022, we had
approximately 182.8 million ordinary shares outstanding.
Research and development (R&D) expenses for the fourth
quarter and full year 2021 were $3.7 million and $10.7 million,
respectively, compared to $2.4 million and $21.1 million for
the same periods in 2020. The increase for the three-month
period was primarily due to the non-cash amortization of an
intangible asset in 2021. The decrease in R&D expenses for the
full year was primarily due to the completion of Iterum’s Phase 3
trials in 2020.
General and administrative (G&A) expenses for the fourth
quarter and full year 2021 were $3.1 million and $13.8 million,
respectively, compared to $2.3 million and $11.1 million for
the same periods in 2020. The increase for three-month period
was primarily due to an increase in share-based compensation, and
the increase in G&A expense for the full year was primarily due
to higher spend on pre-commercialization activities in the first
half of 2021 and higher share-based compensation expense, partially
offset by lower G&A headcount.
Adjustments to the fair value of derivatives for the fourth
quarter and full year 2021 were $3.6 million and ($61.0) million,
compared to ($2.7) million and ($1.7) million for the same periods
in 2020. The non-cash adjustment in the fourth quarter of 2021
primarily related to a decrease in the value of the derivative
components associated with Iterum’s 6.500% Exchangeable Senior
Subordinated Notes due 2025 (the Exchangeable Notes) as a result of
a decrease in the price of its ordinary shares and market
capitalization during the period. The non-cash adjustment for the
full year was largely due to the fair value adjustments recorded at
the time of conversion of $39.2 million of the Exchangeable Notes
in 2021.
Net loss for the fourth quarter and full year 2021 was $4.2
million and $91.6 million, respectively, compared to a net loss of
$11.2 million and $52.0 million for the same periods in 2020.
Non-GAAP1 net loss for the fourth quarter and full year 2021 of
$3.3 million and $19.4 million, respectively, compared to a
non-GAAP1 net loss of $4.4 million and $30.9 million for the same
periods in 2020.
Upcoming Investor Presentations
- Corporate presentation at the 2022 H.C. Wainwright Global
Investment Conference to be held May 23-25, 2022
Conference Call Details
- Iterum will host a conference call today, Monday,
March 28, 2022 at 8:30 a.m. Eastern Time. The dial-in
information for the call is as follows: United States: 1 844 200
6205; International: 1 929 526 1599; Access code: 096194
1 Reconciliations of applicable GAAP reported to non-GAAP
adjusted information are included at the end of this press
release
About Iterum Therapeutics plc
Iterum Therapeutics plc is a clinical-stage pharmaceutical
company dedicated to developing differentiated anti-infectives
aimed at combatting the global crisis of multi-drug resistant
pathogens to significantly improve the lives of people affected by
serious and life-threatening diseases around the world. Iterum is
currently advancing its first compound, sulopenem, a novel penem
anti-infective compound, in Phase 3 clinical development with an
oral formulation. Sulopenem also has an IV formulation. Sulopenem
has demonstrated potent in vitro activity against a wide variety of
gram-negative, gram-positive and anaerobic bacteria resistant to
other antibiotics. Iterum has received Qualified Infectious Disease
Product (QIDP) and Fast Track designations for its oral and IV
formulations of sulopenem in seven indications. For more
information, please visit http://www.iterumtx.com.
Non-GAAP Financial Measures
To supplement Iterum’s financial results presented in accordance
with U.S. generally accepted accounting principles (“GAAP”), Iterum
presents non-GAAP net loss and non-GAAP net loss per share to
exclude from reported GAAP net loss and GAAP net loss per share,
intangible asset amortization ($1.7 million and $1.7 million);
share-based compensation expense ($2.0 million and $4.3 million);
the interest expense associated with accrued interest on the
Exchangeable Notes, payable in cash, shares or a combination of
both upon exchange, redemption or at January 31, 2025 (“the
Maturity Date”), whichever is earlier ($0.2 million and $1.1
million); the non-cash amortization of the Exchangeable Notes and
Royalty-Linked Notes ($0.6 million and $4.1 million); and the
non-cash adjustments to the fair value of derivatives ($3.6 million
and $61.0 million) for the three and twelve months ended December
31, 2021, respectively, and share-based compensation expense ($0.1
million and $2.8 million); the interest expense associated with
accrued interest on the Exchangeable Notes payable in cash, shares
or a combination of both upon exchange, redemption or at the
Maturity Date, whichever is earlier ($0.8 million and $3.2
million); the non-cash amortization of the Exchangeable Notes and
Royalty-Linked Notes ($3.1 million and $10.5 million); one-time,
non-capitalized financing transaction costs ($0.0 million and $2.8
million); and the non-cash adjustments to the fair value of
derivatives ($2.8 million and $1.7 million) for the three and
twelve months ended December 31, 2020, respectively.
Iterum believes that the presentation of non-GAAP net loss and
non-GAAP net loss per share, when viewed with its results under
GAAP and the accompanying reconciliation, provides useful
supplementary information to, and facilitates additional analysis
by, investors, analysts, and Iterum’s management in assessing
Iterum’s performance and results from period to period. These
non-GAAP financial measures closely align with the way management
measures and evaluates Iterum’s performance. These non-GAAP
financial measures should be considered in addition to, and not a
substitute for, or superior to, net loss or other financial
measures calculated in accordance with GAAP. Non-GAAP net loss and
non-GAAP net loss per share are not based on any standardized
methodology prescribed by GAAP and represents GAAP net loss, which
is the most directly comparable GAAP measure, adjusted to exclude
intangible asset amortization; share-based compensation expense;
the interest expense associated with accrued interest on the
Exchangeable Notes payable in cash, shares or a combination of both
upon exchange, redemption or at the Maturity Date, whichever is
earlier; the non-cash amortization of the Exchangeable Notes and
Royalty-Linked Notes; one-time, non-capitalized financing
transaction costs and the non-cash adjustments to the fair value of
derivatives for the three and twelve months ended December 31, 2021
and December 31, 2020. Because of the non-standardized definitions
of non-GAAP financial measures, non-GAAP net loss and non-GAAP net
loss per share used by Iterum Therapeutics in this press release
and accompanying tables has limits in its usefulness to investors
and may be calculated differently from, and therefore may not be
directly comparable to, similarly titled measures used by other
companies. A reconciliation of non-GAAP net loss to GAAP net loss
and non-GAAP net loss per share to GAAP net loss per share have
been provided in the tables included in this press release.
Forward Looking Statements
This press release contains forward-looking statements. These
forward-looking statements include, without limitation, statements
regarding Iterum’s plans, strategies and prospects for its
business, including with respect to planned interactions and
communications with the FDA and Iterum’s ability to reach agreement
with the FDA on the design of any potential future clinical trials,
Iterum’s expectations with regard to its ability to resolve the
matters set forth in the complete response letter (CRL) received by
Iterum in July 2021 and obtain approval for oral sulopenem, the
timing and conduct of potential future clinical and non-clinical
development of sulopenem, and the sufficiency of Iterum’s cash
resources. In some cases, forward-looking statements can be
identified by words such as “may,” “believes,” “intends,” “seeks,”
“anticipates,” “plans,” “estimates,” “expects,” “should,”
“assumes,” “continues,” “could,” “would,” “will,” “future,”
“potential” or the negative of these or similar terms and phrases.
Forward-looking statements involve known and unknown risks,
uncertainties and other factors that may cause Iterum’s actual
results, performance or achievements to be materially different
from any future results, performance or achievements expressed or
implied by the forward-looking statements. Forward-looking
statements include all matters that are not historical facts.
Actual future results may be materially different from what is
expected due to factors largely outside Iterum’s control, including
uncertainties inherent in the initiation and conduct of clinical
and non-clinical development, including any potential additional
clinical trials and non-clinical development that may be conducted
in response to the CRL, availability and timing of data from such
potential clinical and non-clinical development, changes in
regulatory requirements or decisions of regulatory authorities, the
timing or likelihood of regulatory filings and approvals, including
any potential resubmission of the NDA for oral sulopenem, changes
in public policy or legislation, commercialization plans and
timelines, if oral sulopenem is approved, the actions of
third-party clinical research organizations, suppliers and
manufacturers, the accuracy of Iterum’s expectations regarding how
far into the future Iterum’s cash on hand will fund Iterum’s
ongoing operations including completing potential additional
clinical and non-clinical development of oral sulopenem, the impact
of COVID-19 and related responsive measures thereto, Iterum’s
ability to maintain its listing on the Nasdaq Stock Market, risks
and uncertainties concerning the outcome, impact, effects and
results of Iterum’s evaluation of corporate, strategic, financial
and financing alternatives, including the terms, timing, structure,
value, benefits and costs of any corporate, strategic, financial or
financing alternative and Iterum’s ability to complete one at all
and other factors discussed under the caption “Risk Factors” in its
Annual Report on Form 10-K filed with the Securities and Exchange
Commission (the “SEC”) on March 28, 2022, and other documents filed
with the SEC from time to time. Forward-looking statements
represent Iterum’s beliefs and assumptions only as of the date of
this press release. Except as required by law, Iterum assumes no
obligation to update these forward-looking statements publicly, or
to update the reasons actual results could differ materially from
those anticipated in the forward-looking statements, even if new
information becomes available in the future.
Investor Contact:Judy MatthewsChief Financial
Officer312-778-6073IR@iterumtx.com
ITERUM
THERAPEUTICS PLC |
Consolidated
Statement of Operations |
(In
thousands except share and per share data) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
Three months
endedDecember 31, |
|
Year
endedDecember 31, |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research and
development |
|
$ |
(3,702 |
) |
|
$ |
(2,351 |
) |
|
$ |
(10,712 |
) |
|
$ |
(21,074 |
) |
General and
administrative |
|
|
(3,127 |
) |
|
|
(2,293 |
) |
|
|
(13,825 |
) |
|
|
(11,052 |
) |
Total
operating expenses |
|
|
(6,829 |
) |
|
|
(4,644 |
) |
|
|
(24,537 |
) |
|
|
(32,126 |
) |
Operating
loss |
|
|
(6,829 |
) |
|
|
(4,644 |
) |
|
|
(24,537 |
) |
|
|
(32,126 |
) |
Interest
expense, net |
|
|
(772 |
) |
|
|
(4,243 |
) |
|
|
(5,553 |
) |
|
|
(15,097 |
) |
Financing
transaction costs |
|
|
— |
|
|
|
(33 |
) |
|
|
— |
|
|
|
(2,848 |
) |
Adjustments
to fair value of derivatives |
|
|
3,562 |
|
|
|
(2,768 |
) |
|
|
(60,964 |
) |
|
|
(1,745 |
) |
Extinguishment of debt |
|
|
— |
|
|
|
340 |
|
|
|
— |
|
|
|
340 |
|
Other
income, net |
|
|
28 |
|
|
|
186 |
|
|
|
195 |
|
|
|
213 |
|
Income tax
expense |
|
|
(171 |
) |
|
|
(24 |
) |
|
|
(705 |
) |
|
|
(743 |
) |
Net loss
attributable to ordinary shareholders |
|
$ |
(4,182 |
) |
|
$ |
(11,186 |
) |
|
$ |
(91,564 |
) |
|
$ |
(52,006 |
) |
Net loss per
share attributable to ordinary shareholders – basic |
|
$ |
(0.02 |
) |
|
$ |
(0.28 |
) |
|
$ |
(0.56 |
) |
|
$ |
(2.17 |
) |
Weighted
average ordinary shares outstanding – basic |
|
|
182,775,282 |
|
|
|
40,645,864 |
|
|
|
163,367,681 |
|
|
|
24,009,818 |
|
|
|
|
|
|
|
|
|
|
Reconciliation of non-GAAP net loss to GAAP net loss |
|
|
|
|
|
|
|
|
Net loss -
GAAP |
|
$ |
(4,182 |
) |
|
$ |
(11,186 |
) |
|
$ |
(91,564 |
) |
|
$ |
(52,006 |
) |
Intangible
asset amortization |
|
|
1,713 |
|
|
|
— |
|
|
|
1,713 |
|
|
|
— |
|
Share-based
compensation expense |
|
|
1,967 |
|
|
|
126 |
|
|
|
4,319 |
|
|
|
2,759 |
|
Interest
expense - accrued interest and amortization on Exchangeable Notes
and Royalty-Linked Notes |
|
|
796 |
|
|
|
3,877 |
|
|
|
5,175 |
|
|
|
13,706 |
|
Financing
transaction costs - not capitalized |
|
|
— |
|
|
|
(33 |
) |
|
|
— |
|
|
|
2,848 |
|
Adjustments
to fair value of derivatives |
|
|
(3,562 |
) |
|
|
2,768 |
|
|
|
60,964 |
|
|
|
1,745 |
|
Non-GAAP net
loss |
|
$ |
(3,268 |
) |
|
$ |
(4,448 |
) |
|
$ |
(19,393 |
) |
|
$ |
(30,948 |
) |
Net loss per
share attributable to ordinary shareholders – basic and
diluted |
|
$ |
(0.02 |
) |
|
$ |
(0.28 |
) |
|
$ |
(0.56 |
) |
|
$ |
(2.17 |
) |
Non-GAAP net
loss per share attributable to ordinary shareholders – basic and
diluted |
|
$ |
(0.02 |
) |
|
$ |
(0.11 |
) |
|
$ |
(0.12 |
) |
|
$ |
(1.29 |
) |
|
|
|
|
|
|
|
|
|
ITERUM
THERAPEUTICS PLC |
|
|
|
|
Consolidated
Balance Sheet Data |
|
|
|
|
(In
thousands) |
|
|
|
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As
of |
|
As
of |
|
|
|
|
|
|
December
31, |
|
December
31, |
|
|
|
|
|
|
|
2021 |
|
|
|
2020 |
|
|
|
|
|
Cash, cash
equivalents and short-term investments |
|
$ |
81,344 |
|
|
$ |
14,508 |
|
|
|
|
|
Other
assets |
|
|
10,165 |
|
|
|
18,284 |
|
|
|
|
|
Total assets |
|
$ |
91,509 |
|
|
$ |
32,792 |
|
|
|
|
|
Long-term
debt, less current portion |
|
$ |
6,930 |
|
|
$ |
22,462 |
|
|
|
|
|
Royalty-linked notes, less current portion |
|
|
17,968 |
|
|
|
13,389 |
|
|
|
|
|
Derivative
liabilities |
|
|
6,058 |
|
|
|
28,865 |
|
|
|
|
|
Other
liabilities |
|
|
10,319 |
|
|
|
18,635 |
|
|
|
|
|
Total
liabilities |
|
|
41,275 |
|
|
|
83,351 |
|
|
|
|
|
Total
shareholders' equity / (deficit ) |
|
|
50,234 |
|
|
|
(50,559 |
) |
|
|
|
|
Total liabilities and shareholders' equity /
(deficit) |
|
$ |
91,509 |
|
|
$ |
32,792 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Iterum Therapeutics (NASDAQ:ITRM)
Historical Stock Chart
From Mar 2024 to Apr 2024
Iterum Therapeutics (NASDAQ:ITRM)
Historical Stock Chart
From Apr 2023 to Apr 2024