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 second quarter ended June 30,
2021.
“Despite our disappointment with the FDA’s
Complete Response Letter (“CRL”), we’ve begun preparations for the
Type A meeting with the FDA expected later this quarter and we hope
to receive adequate guidance and agreement with the FDA on a path
forward that will lead to resubmission of our New Drug Application
(“NDA”) as quickly as possible,” said Corey Fishman, Chief
Executive Officer.
Highlights and Recent Events
- FDA completes review of NDA: On July 23, 2021,
we received a CRL from the U.S. Food and Drug Administration
(“FDA”) with respect to our NDA for oral sulopenem for the
treatment of uncomplicated urinary tract infections in patients
with a quinolone non-susceptible organism, stating that the FDA
could not approve the NDA in its present form. The CRL provided
that additional data are necessary to support approval of oral
sulopenem and recommended that we conduct at least one additional
adequate and well-controlled clinical trial, potentially using a
different comparator drug. Additionally, the FDA recommended that
we conduct further non-clinical investigation to determine the
optimal dosing regimen, although the FDA stated that this
recommendation does not raise an approvability issue. We plan to
have a Type A meeting with the FDA to identify the next steps as to
the potential additional clinical and non-clinical work to support
a potential resubmission of the NDA for approval of oral sulopenem.
The meeting is expected to take place near the end of the third
quarter.
- Cash runway into second half of 2023: 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 for sulopenem, we believe that we are well
positioned financially to fund operations into the second half of
2023. Following receipt of the CRL, in order to reduce operating
expenses and conserve cash resources, we halted any remaining
pre-commercial activities for oral sulopenem and plan to limit
spending to essential costs required in connection with the
potential resubmission of the NDA. If and when we believe
regulatory approval of oral sulopenem appears likely, we plan to
resume pre-commercialization activities and negotiations on a
definitive agreement for commercialization services. As of June 30,
2021, we had approximately 182.6 million ordinary shares
outstanding.
Second Quarter 2021 Financial
Results
As of June 30, 2021, Iterum had cash, cash
equivalents and short-term investments of $91.4 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 for sulopenem, Iterum expects that its
current cash, cash equivalents and short-term investments will be
sufficient to fund its operations into the second half of 2023.
Research and development expenses for the second
quarter of 2021 were $2.7 million compared to $5.0 million for the
same period in 2020. The decrease for the period was primarily due
to the completion of our Phase 3 clinical trials in 2020.
General and administrative (G&A) expenses for
the second quarter of 2021 were $4.3 million compared to $3.2
million for the same period in 2020. The increase for the period
was primarily due to higher spending on pre-commercialization
activities and consultants to support our G&A function,
partially offset by lower G&A headcount.
Adjustments to the fair value of derivatives for
the second quarter 2021 were $15.8 million compared to $0.0 million
for the same period in 2020. This non-cash adjustment in the second
quarter of 2021 primarily related to a decrease in the fair value
of Iterum’s Limited Recourse Royalty-Linked Subordinated Notes (the
Royalty-Linked Notes), which were issued in 2020.
For the second quarter of 2021, Iterum reported
net income of $7.8 million compared to a net loss of $12.5 million
for the same period in 2020 due largely to the non-cash adjustment
associated with Iterum’s Royalty-Linked Notes in the second quarter
of 2021. On a non-GAAP basis, Iterum reported a non-GAAP1 net loss
of $7.2 million for the second quarter of 2021 compared to a
non-GAAP net loss of $8.8 million for the same period in 2020.
Upcoming Investor
Presentation
- Corporate presentation at the H.C. Wainwright 23rd Annual
Global Investment Conference in New York, NY on September 13, 2021
at 12:00pm ET
Conference Call Details
- Iterum will host a conference call today, Friday,
August 13, 2021 at 8:30 a.m. Eastern Time. The dial-in
information for the call is as follows: United States: 1 844 200
6205 (Toll Free); United States (Local): 1 646 904 5544 (Local);
All Other Locations: + 44 208 0682 558; Access code: 096194
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 Therapeutics is advancing its first compound, sulopenem, a
novel penem anti-infective compound, in Phase 3 clinical
development with oral and IV formulations. Sulopenem has
demonstrated potent in vitro activity against a wide variety of
gram-negative, gram-positive and anaerobic bacteria resistant to
other antibiotics. Iterum Therapeutics 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 Therapeutics’ financial
results presented in accordance with U.S. generally accepted
accounting principles (“GAAP”), Iterum Therapeutics 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 (“ ENs”), 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 $0.7 million); the non-cash amortization of the
ENs 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, and the interest expense associated with
accrued interest on the ENs payable in cash, shares or a
combination of both upon exchange, redemption or at the Maturity
Date, whichever is earlier ($0.8 million and $1.5 million); the
non-cash amortization of the ENs and Royalty-Linked Notes ($2.9
million and $4.5 million); one-time, non-capitalized financing
transaction costs ($0.0 million and $2.1 million) and the
offsetting non-cash adjustments to the fair value of derivatives
($0.0 million and $1.7 million) for the three and six months ended
June 30, 2020, respectively.
Iterum Therapeutics 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
Therapeutics’ management in assessing Iterum Therapeutics’
performance and results from period to period. These non-GAAP
financial measures closely align with the way management measures
and evaluates Iterum Therapeutics’ 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 ENs 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 ENs
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 six months ended June 30, 2021 and
June 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 the Company’s plans, strategies
and prospects for its business, including with respect to planned
interactions and communications with the FDA, the Company’s
expectations with regard to its ability to resolve the matters set
forth in the CRL and obtain approval for oral sulopenem, the
conduct of potential future clinical and non-clinical development
of sulopenem, the potential timing for resuming
pre-commercialization activities, and the sufficiency of the
Company’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 the Company’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 the Company’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 the Company’s expectations regarding how far into the future the
Company’s cash on hand will fund the Company’s ongoing operations,
the impact of COVID-19 and related responsive measures thereto,
risks and uncertainties concerning the outcome, impact, effects and
results of the Company’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 the Company’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 13, 2021,
and other documents filed with the SEC from time to time.
Forward-looking statements represent the Company’s beliefs and
assumptions only as of the date of this press release. Except as
required by law, the Company 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, |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research and
development |
|
(2,714 |
) |
|
|
(5,043 |
) |
|
|
(5,165 |
) |
|
|
(14,786 |
) |
|
General and
administrative |
|
(4,273 |
) |
|
|
(3,210 |
) |
|
|
(7,669 |
) |
|
|
(6,361 |
) |
|
Total
operating expenses |
|
(6,987 |
) |
|
|
(8,253 |
) |
|
|
(12,834 |
) |
|
|
(21,147 |
) |
|
Operating
loss |
|
(6,987 |
) |
|
|
(8,253 |
) |
|
|
(12,834 |
) |
|
|
(21,147 |
) |
|
Interest
expense, net |
|
(980 |
) |
|
|
(4,075 |
) |
|
|
(3,932 |
) |
|
|
(6,671 |
) |
|
Financing
transaction costs |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(2,130 |
) |
|
Adjustments
to fair value of derivatives |
|
15,794 |
|
|
|
(12 |
) |
|
|
(74,309 |
) |
|
|
1,667 |
|
|
Other income
/ (expense), net |
|
93 |
|
|
|
(3 |
) |
|
|
134 |
|
|
|
(41 |
) |
|
Income tax
expense |
|
(122 |
) |
|
|
(178 |
) |
|
|
(182 |
) |
|
|
(299 |
) |
|
Net income/
(loss) attributable to ordinary shareholders |
$ |
7,798 |
|
|
$ |
(12,521 |
) |
|
$ |
(91,123 |
) |
|
$ |
(28,621 |
) |
|
Net income /
(loss) per share attributable to ordinary shareholders – basic |
$ |
0.04 |
|
|
$ |
(0.80 |
) |
|
$ |
(0.63 |
) |
|
$ |
(1.87 |
) |
|
Net income /
(loss) per share attributable to ordinary shareholders –
diluted |
$ |
0.04 |
|
|
$ |
(0.80 |
) |
|
$ |
(0.63 |
) |
|
$ |
(1.87 |
) |
|
Weighted
average ordinary shares outstanding – basic |
|
180,017,313 |
|
|
|
15,614,767 |
|
|
|
144,608,227 |
|
|
|
15,295,141 |
|
|
Weighted
average ordinary shares outstanding – diluted |
|
204,600,645 |
|
|
|
15,614,767 |
|
|
|
144,608,227 |
|
|
|
15,295,141 |
|
|
|
|
|
|
|
|
|
|
|
Reconciliation of non-GAAP net income / (loss) to GAAP net
loss |
|
|
|
|
|
|
|
Net income /
(loss) - GAAP |
$ |
7,798 |
|
|
$ |
(12,521 |
) |
|
$ |
(91,123 |
) |
|
$ |
(28,621 |
) |
|
Interest
expense - accrued interest and amortization on Exchangeable Notes
and Royalty-Linked Notes |
|
835 |
|
|
|
3,704 |
|
|
|
3,583 |
|
|
|
5,970 |
|
|
Financing
transaction costs - not capitalized |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
2,130 |
|
|
Adjustments
to fair value of derivatives |
|
(15,794 |
) |
|
|
12 |
|
|
|
74,309 |
|
|
|
(1,667 |
) |
|
Non-GAAP net
loss |
$ |
(7,161 |
) |
|
$ |
(8,805 |
) |
|
$ |
(13,231 |
) |
|
$ |
(22,188 |
) |
|
Net income /
(loss) per share attributable to ordinary shareholders – basic |
$ |
0.04 |
|
|
$ |
(0.80 |
) |
|
$ |
(0.63 |
) |
|
$ |
(1.87 |
) |
|
Net income /
(loss) per share attributable to ordinary shareholders –
diluted |
$ |
0.04 |
|
|
$ |
(0.80 |
) |
|
$ |
(0.63 |
) |
|
$ |
(1.87 |
) |
|
Non-GAAP net
loss per share attributable to ordinary shareholders – basic and
diluted |
$ |
(0.04 |
) |
|
$ |
(0.56 |
) |
|
$ |
(0.09 |
) |
|
$ |
(1.45 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ITERUM
THERAPEUTICS PLC |
Condensed
Consolidated Balance Sheet Data |
(In
thousands) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
As
of |
|
As
of |
|
|
|
|
|
|
June
30, |
|
December
31, |
|
|
|
|
|
|
|
2021 |
|
|
|
2020 |
|
|
|
|
|
|
Cash, cash
equivalents and short-term investments |
$ |
91,440 |
|
|
$ |
14,508 |
|
|
|
|
|
|
Other
assets |
|
14,605 |
|
|
|
18,284 |
|
|
|
|
|
|
Total assets |
$ |
106,045 |
|
|
$ |
32,792 |
|
|
|
|
|
|
Long-term
debt, less current portion |
$ |
5,339 |
|
|
|
22,462 |
|
|
|
|
|
|
Royalty-linked notes, less current portion |
|
15,315 |
|
|
|
13,389 |
|
|
|
|
|
|
Derivative
liabilities |
|
21,864 |
|
|
|
28,865 |
|
|
|
|
|
|
Other
liabilities |
|
16,332 |
|
|
|
18,635 |
|
|
|
|
|
|
Total
liabilities |
$ |
58,850 |
|
|
$ |
83,351 |
|
|
|
|
|
|
Total
shareholders' equity / (deficit ) |
$ |
47,195 |
|
|
$ |
(50,559 |
) |
|
|
|
|
|
Total liabilities and shareholders' equity /
(deficit) |
$ |
106,045 |
|
|
$ |
32,792 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1 Reconciliations of applicable GAAP reported to non-GAAP
adjusted information are included at the end of this press
release
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