Iterum Therapeutics plc (Nasdaq: ITRM) (“Iterum”), 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 second quarter ended June 30,
2022.
“We are excited to start our planned Phase 3
clinical trial in uncomplicated urinary tract infections (“uUTI”)
in the coming months,” said Corey Fishman, Chief Executive Officer.
“As previously announced, we reached an agreement with the U.S.
Food and Drug Administration (“FDA”) on the key elements of the
trial design for oral sulopenem etzadroxil-probenecid (“oral
sulopenem”) for the treatment of uUTI under the special protocol
assessment (“SPA”) process. If successful, we believe oral
sulopenem would be a viable treatment option to combat the
increasing crisis of bacterial resistance in the community.”
Highlights and Recent Events
- Received SPA in July 2022:
Reached an agreement with the FDA under the SPA process on the
design, endpoints and statistical analysis of a Phase 3 clinical
trial for oral sulopenem for the treatment of uUTI. The SPA
agreement provides that the design and planned analysis of the
trial, as set out in the protocol submitted to the FDA, adequately
addresses the objectives necessary to support the potential
resubmission of the Company’s new drug application (“NDA”) for oral
sulopenem.
Second Quarter 2022 Financial
Results
Cash, cash equivalents and short-term investments
was $68.9 million at June 30, 2022. Based on the current operating
plan, Iterum expects that its current cash, cash equivalents and
short-term investments will be sufficient to fund its operations
into 2024. As of July 31, 2022, Iterum had approximately 183.5
million ordinary shares outstanding.
Research and development (“R&D”) expenses for
the second quarter of 2022 were $4.0 million compared to $2.7
million for the same period in 2021. The increase was primarily due
to higher personnel costs due to an increase in headcount to
support additional clinical trial efforts and higher share-based
compensation, trial start-up costs associated with the uUTI trial
expected to begin enrollment in the fourth quarter of 2022, and the
non-cash amortization of an intangible asset in 2022, partially
offset by lower consulting spend.
General and administrative (G&A) expenses for
the second quarter of 2022 were $4.1 million compared to $4.3
million for the same period in 2021. The decrease was primarily due
to lower consulting spend used to support pre-commercialization
activities versus the prior year, partially offset by an increase
in headcount and share-based compensation expense.
Adjustments to the fair value of derivatives for
the second quarter of 2022 were $2.2 million compared to $15.8
million for the same period in 2021. The non-cash adjustment in the
second quarter of 2022 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, partially offset by an increase
in the liability associated with the Limited Recourse
Royalty-Linked Subordinated Notes (the “Royalty-Linked Notes”) due
to timing of expected payments. The non-cash adjustment in the
second quarter of 2021 was largely associated with a decrease in
the value of the Royalty-Linked Notes during the period.
Net loss for the second quarter of 2022 was $6.7
million compared to net income of $7.8 million for the same period
in 2021. Non-GAAP1 net loss was $5.7 million in the second quarter
of 2022 compared to the non-GAAP1 net loss of $6.6 million for the
same period in 2021.
Upcoming Presentations
- Corporate presentation at the H.C. Wainwright 24th Annual
Global Investment Conference to be held September 12-14, 2022
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) / income and
GAAP net (loss) / income per share, intangible asset amortization
($0.4 million and $0.9 million); share-based compensation expense
($2.0 million and $3.9 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 $0.4 million); the non-cash amortization of the
Exchangeable Notes and Royalty-Linked Notes ($0.6 million and $1.2
million); and the non-cash adjustments to the fair value of
derivatives ($2.2 million and $7.3 million) for the three and six
months ended June 30, 2022, respectively, and share-based
compensation expense ($0.6 million and $0.8 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 ($0.2
million and $0.7 million); the non-cash amortization of the
Exchangeable Notes and Royalty-Linked Notes ($0.6 million and $2.9
million); and the non-cash adjustments to the fair value of
derivatives ($15.8 million and $74.3 million) for the three and six
months ended June 30, 2021, 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) / income 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) / income, 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; and the non-cash
adjustments to the fair value of derivatives for the three and six
months ended June 30, 2022 and June 30, 2021. 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) / income and non-GAAP net
loss per share to GAAP net (loss) / income 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 the timing and conduct of a
planned Phase 3 clinical trial and non-clincial development of
sulopenem to support a potential resubmission of the NDA for oral
sulopenem and 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, 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 design,
initiation and conduct of clinical and non-clinical development,
including the planned clinical trial and non-clinical development
to be conducted in response to the CRL, availability and timing of
data from the planned 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, the impact of
COVID-19 and related responsive measures thereto, Iterum’s ability
to maintain its listing on the Nasdaq Capital 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
Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission (the “SEC”) on August 12, 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 Matthews
Chief Financial Officer 312-778-6073 IR@iterumtx.com
ITERUM
THERAPEUTICS PLC |
Condensed
Consolidated Statement of Operations |
(In
thousands except share and per share data) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended June 30, |
|
Six Months
Ended June 30, |
|
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research and
development |
|
|
(3,984 |
) |
|
|
(2,714 |
) |
|
|
(7,424 |
) |
|
|
(5,165 |
) |
General and
administrative |
|
|
(4,066 |
) |
|
|
(4,273 |
) |
|
|
(7,999 |
) |
|
|
(7,669 |
) |
Total
operating expenses |
|
|
(8,050 |
) |
|
|
(6,987 |
) |
|
|
(15,423 |
) |
|
|
(12,834 |
) |
Operating
loss |
|
|
(8,050 |
) |
|
|
(6,987 |
) |
|
|
(15,423 |
) |
|
|
(12,834 |
) |
Interest
expense, net |
|
|
(766 |
) |
|
|
(980 |
) |
|
|
(1,805 |
) |
|
|
(3,932 |
) |
Adjustments
to fair value of derivatives |
|
|
2,155 |
|
|
|
15,794 |
|
|
|
7,332 |
|
|
|
(74,309 |
) |
Other
income, net |
|
|
269 |
|
|
|
93 |
|
|
|
431 |
|
|
|
134 |
|
Income tax
expense |
|
|
(343 |
) |
|
|
(122 |
) |
|
|
(770 |
) |
|
|
(182 |
) |
Net (loss) /
income attributable to ordinary shareholders |
|
$ |
(6,735 |
) |
|
$ |
7,798 |
|
|
$ |
(10,235 |
) |
|
$ |
(91,123 |
) |
Net (loss) /
income per share attributable to ordinary shareholders – basic |
|
$ |
(0.04 |
) |
|
$ |
0.04 |
|
|
$ |
(0.06 |
) |
|
$ |
(0.63 |
) |
Net (loss) /
income per share attributable to ordinary shareholders –
diluted |
|
$ |
(0.04 |
) |
|
$ |
0.04 |
|
|
$ |
(0.06 |
) |
|
$ |
(0.63 |
) |
Weighted
average ordinary shares outstanding – basic |
|
|
183,364,740 |
|
|
|
180,017,313 |
|
|
|
183,134,415 |
|
|
|
144,608,227 |
|
Weighted
average ordinary shares outstanding – diluted |
|
|
183,364,740 |
|
|
|
204,600,645 |
|
|
|
183,134,415 |
|
|
|
144,608,227 |
|
|
|
|
|
|
|
|
|
|
Reconciliation of GAAP net (loss) / income to non-GAAP net
loss |
|
|
|
|
|
|
|
|
Net (loss) /
income - GAAP |
|
$ |
(6,735 |
) |
|
$ |
7,798 |
|
|
$ |
(10,235 |
) |
|
$ |
(91,123 |
) |
Intangible
asset amortization |
|
|
429 |
|
|
|
— |
|
|
|
858 |
|
|
|
— |
|
Share based
compensation |
|
|
1,984 |
|
|
|
559 |
|
|
|
3,879 |
|
|
|
840 |
|
Interest
expense - accrued interest and amortization on Exchangeable Notes
and Royalty-Linked Notes |
|
|
789 |
|
|
|
835 |
|
|
|
1,572 |
|
|
|
3,583 |
|
Adjustments
to fair value of derivatives |
|
|
(2,155 |
) |
|
|
(15,794 |
) |
|
|
(7,332 |
) |
|
|
74,309 |
|
Non-GAAP net
loss |
|
$ |
(5,688 |
) |
|
$ |
(6,602 |
) |
|
$ |
(11,258 |
) |
|
$ |
(12,391 |
) |
Net (loss) /
income per share attributable to ordinary shareholders – basic |
|
$ |
(0.04 |
) |
|
$ |
0.04 |
|
|
$ |
(0.06 |
) |
|
$ |
(0.63 |
) |
Net (loss) /
income per share attributable to ordinary shareholders –
diluted |
|
$ |
(0.04 |
) |
|
$ |
0.04 |
|
|
$ |
(0.06 |
) |
|
$ |
(0.63 |
) |
Non-GAAP Net
loss per share attributable to ordinary shareholders – basic and
diluted |
|
$ |
(0.03 |
) |
|
$ |
(0.04 |
) |
|
$ |
(0.06 |
) |
|
$ |
(0.09 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ITERUM
THERAPEUTICS PLC |
|
|
|
|
Condensed
Consolidated Balance Sheet Data |
|
|
|
|
(In
thousands) |
|
|
|
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As
of |
|
As
of |
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
|
|
|
|
|
2022 |
|
|
|
2021 |
|
|
|
|
|
Cash, cash
equivalents, restricted cash and short-term investments |
|
$ |
68,939 |
|
|
$ |
81,408 |
|
|
|
|
|
Other
assets |
|
|
7,748 |
|
|
|
10,101 |
|
|
|
|
|
Total assets |
|
$ |
76,687 |
|
|
$ |
91,509 |
|
|
|
|
|
Long-term
debt, less current portion |
|
$ |
8,502 |
|
|
$ |
6,930 |
|
|
|
|
|
Royalty-linked notes |
|
|
15,071 |
|
|
|
17,968 |
|
|
|
|
|
Derivative
liabilities |
|
|
1,622 |
|
|
|
6,058 |
|
|
|
|
|
Other
liabilities |
|
|
7,606 |
|
|
|
10,319 |
|
|
|
|
|
Total
liabilities |
|
|
32,801 |
|
|
|
41,275 |
|
|
|
|
|
Total
shareholders' equity |
|
|
43,886 |
|
|
|
50,234 |
|
|
|
|
|
Total liabilities and shareholders' equity |
|
$ |
76,687 |
|
|
$ |
91,509 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1 Reconciliations of applicable GAAP reported to non-GAAP
adjusted information are included at the end of this press
release
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