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 third quarter ended September
30, 2021.
“We had a productive Type A meeting with the U.S.
Food and Drug Administration (FDA) in the third quarter in which
various potential paths forward to support potential resubmission
of our New Drug Application (NDA) for oral sulopenem for the
treatment of uncomplicated urinary tract infections (uUTI) were
discussed. We have since requested a Type B meeting with the FDA
with the goal of reaching agreement on the design of a Phase 3
trial for oral sulopenem for the treatment of uUTI that, if
successful, could lead to a resubmission of our NDA,” said Corey
Fishman, Chief Executive Officer.
Highlights and Recent Events
- Held Type A Meeting with FDA in Q3; Type B Meeting with
FDA Requested: In September 2021, we had a Type A meeting
with the FDA to discuss the steps required for potential
resubmission of the NDA for oral sulopenem following receipt of the
Complete Response Letter (CRL) in July 2021. We have requested a
Type B meeting with the FDA to discuss the design of a potential
new clinical trial to support such potential resubmission.
- Cash runway into 2024: 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 oral sulopenem, we believe that we are well
positioned financially to fund operations into 2024 with our
existing cash resources, which includes completing the proposed
additional development of oral sulopenem to support, if successful,
the resubmission of our NDA to the FDA. As of September 30, 2021,
we had approximately 182.8 million ordinary shares
outstanding.
Third Quarter 2021 Financial
Results
As of September 30, 2021, Iterum had cash, cash
equivalents and short-term investments of $85.7 million. 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.
Research and development expenses for the third
quarter of 2021 were $1.8 million compared to $3.9 million for the
same period in 2020. The decrease for the period was primarily due
to the completion of Iterum’s Phase 3 clinical trials in 2020.
General and administrative (G&A) expenses for
the third quarter of 2021 were $3.0 million compared to $2.4
million for the same period in 2020. The increase for the period
was primarily due to an increase in share-based compensation for
employees and directors.
Adjustments to the fair value of derivatives for
the third quarter of 2021 were $9.8 million compared to ($0.6)
million for the same period in 2020. The non-cash adjustment in the
third 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, partially
offset by an increase in the fair value of Iterum’s Limited
Recourse Royalty-Linked Subordinated Notes (the Royalty-Linked
Notes).
For the third quarter of 2021, Iterum reported net
income of $3.7 million compared to a net loss of $12.2 million for
the same period in 2020 due largely to the non-cash adjustment of
the derivative liabilities in the third quarter of 2021. Iterum
reported a non-GAAP1 net loss of $5.2 million for the third quarter
of 2021 compared to a non-GAAP net loss of $7.0 million for the
same period in 2020.
1 Reconciliations of applicable GAAP reported to
non-GAAP adjusted information are included at the end of this press
release
Upcoming Investor
Presentation
- Corporate presentation at H.C. Wainwright BIOCONNECT Virtual
Conference to be held January 10-13, 2022.
Conference Call Details
- Iterum will host a conference call today, Friday,
November 12, 2021 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: 442364
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 adjusted net loss and non-GAAP
net loss per share to exclude from reported GAAP net income/(loss)
and GAAP net income/(loss) per share, 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 $0.9 million); the non-cash amortization of the
Exchangeable Notes and Royalty-Linked Notes ($0.6 million and $3.5
million); and the non-cash adjustments to the fair value of
derivatives ($9.8 million and $64.5 million) for the three and nine
months ended September 30, 2021, respectively, and 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 ($0.9
million and $2.3 million); the non-cash amortization of the
Exchangeable Notes and Royalty-Linked Notes ($3.0 million and $7.5
million); one-time, non-capitalized financing transaction costs
($0.7 million and $2.8 million); and the non-cash adjustments to
the fair value of derivatives ($0.6 million and $1.0 million) for
the three and nine months ended September 30, 2020,
respectively.
Iterum believes that the presentation of non-GAAP
adjusted 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
income/(loss) or other financial measures calculated in accordance
with GAAP. Non-GAAP adjusted net loss and non-GAAP net loss per
share are not based on any standardized methodology prescribed by
GAAP and represents GAAP net income/(loss), which is the most
directly comparable GAAP measure, adjusted to exclude 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 nine months ended September 30, 2021 and September 30,
2020. Because of the non-standardized definitions of non-GAAP
financial measures, non-GAAP adjusted net loss and non-GAAP net
loss per share used by Iterum Therapeutics in the accompanying
press release and tables therein 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 adjusted net loss to
GAAP net income/(loss) and non-GAAP net loss per share to GAAP net
income/(loss) per share have been provided in the tables included
in the accompanying 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 CRL received by
Iterum in July 2021 and obtain approval for oral sulopenem, the
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, 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
Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission (the “SEC”) on November 12, 2021, 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 September 30, |
|
Nine months
ended September 30, |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research and
development |
|
|
(1,845 |
) |
|
|
(3,937 |
) |
|
|
(7,010 |
) |
|
|
(18,723 |
) |
General and
administrative |
|
|
(3,029 |
) |
|
|
(2,398 |
) |
|
|
(10,698 |
) |
|
|
(8,759 |
) |
Total
operating expenses |
|
|
(4,874 |
) |
|
|
(6,335 |
) |
|
|
(17,708 |
) |
|
|
(27,482 |
) |
Operating
loss |
|
|
(4,874 |
) |
|
|
(6,335 |
) |
|
|
(17,708 |
) |
|
|
(27,482 |
) |
Interest
expense, net |
|
|
(849 |
) |
|
|
(4,183 |
) |
|
|
(4,781 |
) |
|
|
(10,854 |
) |
Financing
transaction costs |
|
|
— |
|
|
|
(685 |
) |
|
|
— |
|
|
|
(2,815 |
) |
Adjustments
to fair value of derivatives |
|
|
9,783 |
|
|
|
(644 |
) |
|
|
(64,526 |
) |
|
|
1,023 |
|
Other
income, net |
|
|
33 |
|
|
|
68 |
|
|
|
167 |
|
|
|
27 |
|
Income tax
expense |
|
|
(352 |
) |
|
|
(420 |
) |
|
|
(534 |
) |
|
|
(719 |
) |
Net income/
(loss) attributable to ordinary shareholders |
|
$ |
3,741 |
|
|
$ |
(12,199 |
) |
|
$ |
(87,382 |
) |
|
$ |
(40,820 |
) |
Net income /
(loss) per share attributable to ordinary shareholders – basic |
|
$ |
0.02 |
|
|
$ |
(0.60 |
) |
|
$ |
(0.56 |
) |
|
$ |
(2.39 |
) |
Net income /
(loss) per share attributable to ordinary shareholders –
diluted |
|
$ |
0.02 |
|
|
$ |
(0.60 |
) |
|
$ |
(0.56 |
) |
|
$ |
(2.39 |
) |
Weighted
average ordinary shares outstanding – basic |
|
|
182,730,032 |
|
|
|
20,392,357 |
|
|
|
156,058,343 |
|
|
|
17,078,326 |
|
Weighted
average ordinary shares outstanding – diluted |
|
|
202,257,112 |
|
|
|
20,392,357 |
|
|
|
156,058,343 |
|
|
|
17,078,326 |
|
|
|
|
|
|
|
|
|
|
Reconciliation of non-GAAP net income / (loss) to GAAP net
loss |
|
|
|
|
|
|
Net income /
(loss) - GAAP |
|
$ |
3,741 |
|
|
$ |
(12,199 |
) |
|
$ |
(87,382 |
) |
|
$ |
(40,820 |
) |
Interest
expense - accrued interest and amortization on Exchangeable Notes
and Royalty-Linked Notes |
|
|
796 |
|
|
|
3,859 |
|
|
|
4,379 |
|
|
|
9,829 |
|
Financing
transaction costs - not capitalized |
|
|
— |
|
|
|
685 |
|
|
|
— |
|
|
|
2,815 |
|
Adjustments
to fair value of derivatives |
|
|
(9,783 |
) |
|
|
644 |
|
|
|
64,526 |
|
|
|
(1,023 |
) |
Non-GAAP net
loss |
|
$ |
(5,246 |
) |
|
$ |
(7,011 |
) |
|
$ |
(18,477 |
) |
|
$ |
(29,199 |
) |
Net income /
(loss) per share attributable to ordinary shareholders – basic |
|
$ |
0.02 |
|
|
$ |
(0.60 |
) |
|
$ |
(0.56 |
) |
|
$ |
(2.39 |
) |
Net income /
(loss) per share attributable to ordinary shareholders –
diluted |
|
$ |
0.02 |
|
|
$ |
(0.60 |
) |
|
$ |
(0.56 |
) |
|
$ |
(2.39 |
) |
Non-GAAP net
loss per share attributable to ordinary shareholders – basic and
diluted |
|
$ |
(0.03 |
) |
|
$ |
(0.34 |
) |
|
$ |
(0.12 |
) |
|
$ |
(1.71 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ITERUM
THERAPEUTICS PLC |
Condensed
Consolidated Balance Sheet
Data |
(In
thousands) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
As
of |
|
As
of |
|
|
|
|
|
|
September
30, |
|
December
31, |
|
|
|
|
|
|
|
2021 |
|
|
|
2020 |
|
|
|
|
|
Cash, cash
equivalents and short-term investments |
|
$ |
85,711 |
|
|
$ |
14,508 |
|
|
|
|
|
Other
assets |
|
|
12,711 |
|
|
|
18,284 |
|
|
|
|
|
Total assets |
|
$ |
98,422 |
|
|
$ |
32,792 |
|
|
|
|
|
Long-term
debt, less current portion |
|
$ |
6,134 |
|
|
|
22,462 |
|
|
|
|
|
Royalty-linked notes, less current portion |
|
|
18,403 |
|
|
|
13,389 |
|
|
|
|
|
Derivative
liabilities |
|
|
9,183 |
|
|
|
28,865 |
|
|
|
|
|
Other
liabilities |
|
|
12,254 |
|
|
|
18,635 |
|
|
|
|
|
Total
liabilities |
|
|
45,974 |
|
|
|
83,351 |
|
|
|
|
|
Total
shareholders' equity / (deficit ) |
|
|
52,448 |
|
|
|
(50,559 |
) |
|
|
|
|
Total liabilities and shareholders' equity /
(deficit) |
|
$ |
98,422 |
|
|
$ |
32,792 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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