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 first quarter ended March 31,
2021.
“We continue to prepare for a U.S. Food and Drug
Administration (FDA) advisory committee meeting and look forward to
clarity from the FDA on timing. In the meantime, the FDA continues
its review of our new drug application (NDA) for oral sulopenem for
the treatment of uncomplicated urinary tract infections (uUTI) in
patients with a quinolone non-susceptible organism and has not
advised us of any change to the current PDUFA goal date of July 25,
2021,” said Corey Fishman, Chief Executive Officer. “With an FDA
decision on oral sulopenem expected in the second half of 2021 and
a strong cash position, we are preparing for a launch of oral
sulopenem into the community in the fourth quarter of 2021, if
approved.”
Highlights and Recent Events
- NDA priority review by the FDA is ongoing with current
PDUFA goal date of July 25, 2021: In January 2021, the FDA
accepted for review our NDA for uUTI in patients with a quinolone
non-susceptible organism. The FDA has designated our application as
a priority review and consequently assigned a PDUFA goal date for
completion of the review of oral sulopenem of July 25, 2021. The
FDA previously planned to hold an advisory committee meeting for
oral sulopenem on June 2, 2021 but this meeting was postponed to
allow the FDA more time to review material provided by the Company
in support of the NDA. A new date for such meeting, if
required by the FDA, has not yet been confirmed.
- Extended cash runway into first half of 2023:
In February 2021, we received total net proceeds of $74.3 million
from an underwritten public offering and a registered direct
offering. Based on our current operating plans, we believe our
cash, cash equivalents and short-term investments of $100.5 million
as of March 31, 2021 allows us to operate into the first half of
2023. As of March 31, 2021, we had approximately 179.1 million
ordinary shares outstanding.
- Ongoing collaboration with a third-party provider of
commercialization services: In February 2021, we engaged
EVERSANA™, a leading provider of commercial services to the life
science industry, and we have initiated pre-launch activities. We
are in the process of finalizing an agreement with EVERSANA™ to
provide commercialization services to launch oral sulopenem, if
approved.
First Quarter 2021 Financial
Results
As of March 31, 2021, Iterum had cash, cash
equivalents and short-term investments of $100.5 million. Based on
its current operating plan, Iterum expects that its current cash,
cash equivalents and short-term investments will be sufficient to
fund its operations into the first half of 2023.
Research and development expenses for the first
quarter of 2021 were $2.5 million compared to $9.7 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 first quarter of 2021 were $3.4 million compared to $3.2
million for the same period in 2020. The increase for the period
was primarily due to higher spend 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 first quarter 2021 were $90.1 million compared to $1.7 million
for the same period in 2020. This non-cash adjustment in the first
quarter of 2021 related to an increase in the value of the
derivative components associated with Iterum’s 6.500% Exchangeable
Senior Subordinated Notes due 2025 (the Exchangeable Notes) and
Limited Recourse Royalty-Linked Subordinated Notes (the
Royalty-Linked Notes) issued in 2020 primarily as a result of an
increase in the price of Iterum’s ordinary shares and an increase
in Iterum’s market capitalization during the period.
For the first quarter of 2021, Iterum reported a
net loss of $98.9 million compared to a net loss of $16.1 million
for the same period in 2020 due largely to non-cash adjustments to
the derivative liabilities associated with Iterum’s Exchangeable
Notes and Royalty-Linked Notes. Iterum reported non-GAAP net loss1
of $6.1 million for the first quarter of 2021 compared to non-GAAP
net loss of $13.4 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
Presentations
- Fireside chat at the RBC Capital Markets Global Healthcare
Virtual Conference on Wednesday, May 19, 2021 at 4:15pm ET
- Corporate presentation at the Jefferies Virtual Healthcare
Conference on Tuesday, June 1, 2021 at 1:00pm ET
- Corporate presentation at the JMP Securities Life Sciences
Conference on Thursday, June 17, 2021 at 12:00pm ET
Conference Call and Webcast
Details
- Iterum will host a conference call and webcast
today, Friday, May 14, 2021 at 8:30 a.m. Eastern Time.
To register for this conference call, please use this link:
https://www.incommglobalevents.com/registration/client/7304/iterum-therapeutics-1st-quarter-2021-financial-results-conference-call/
About Sulopenem
Sulopenem, a novel penem anti-infective compound
with oral and IV formulations, has demonstrated potent in
vitro activity against a wide variety of gram-negative,
gram-positive and anaerobic bacteria resistant to other
antibiotics. We believe that sulopenem and oral sulopenem have the
potential to be important new treatment alternatives to address the
growing concerns related to antibacterial resistance without the
known toxicities of some of the most widely used antibiotics,
specifically fluoroquinolones. Our NDA for oral sulopenem for the
treatment of uUTI in patients with a quinolone non-susceptible
pathogen is under FDA review and has a current PDUFA goal date of
July 25, 2021.
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, or GAAP, Iterum Therapeutics presents
non-GAAP adjusted net loss and non-GAAP net loss per share to
exclude from reported GAAP net loss and GAAP net loss per share for
the three months ended March 31, 2021 and March 31, 2020, the
interest expense associated with accrued interest on the
Exchangeable Notes, or ENs, payable in cash, shares or a
combination of both upon exchange, redemption or at January 31,
2025, or the Maturity Date, whichever is earlier ($0.436 million);
the non-cash amortization of the ENs and Royalty-Linked Notes
($2.312 million); and the non-cash adjustments to the fair value of
derivatives ($90.103 million) for the three months ended March 31,
2021, the interest expense associated with accrued interest on the
Exchangeable Notes, or ENs, payable in cash, shares or a
combination of both upon exchange, redemption or at January 31,
2025, or the Maturity Date, whichever is earlier ($0.652 million);
the non-cash amortization of the ENs and Royalty-Linked Notes
($1.613 million); one-time, non-capitalized financing transaction
costs ($2.130 million); and the offsetting non-cash adjustments to
the fair value of derivatives ($1.679 million) for the three months
ended March 31, 2020.
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 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
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
months ended March 31, 2021 and March 31, 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 loss and
non-GAAP net loss per share to GAAP net 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 the
timing of review by the FDA of the Company’s NDA for oral sulopenem
and the related PDUFA date, the holding of an FDA advisory
committee meeting to discuss the NDA, and the Company’s
expectations for potential approval of the NDA on the PDUFA date,
the market potential for sulopenem, commercialization activities
including the ability to enter into a definitive agreement with
respect to commercialization services and to successfully launch
oral sulopenem, if approved, and the sufficiency of the Company’s
cash resources to execute its strategy. 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 the uncertainties inherent in the
initiation and conduct of clinical trials, availability and timing
of data from clinical trials, changes in regulatory requirements or
decisions of regulatory authorities, the timing or likelihood of
regulatory filings and approvals, 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 May 14, 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 March 31, |
|
|
2021 |
|
2020 |
Operating
expenses: |
|
|
|
|
Research and development |
|
|
(2,451 |
) |
|
|
(9,743 |
) |
General and
administrative |
|
|
(3,396 |
) |
|
|
(3,151 |
) |
Total
operating expenses |
|
|
(5,847 |
) |
|
|
(12,894 |
) |
Operating
loss |
|
|
(5,847 |
) |
|
|
(12,894 |
) |
Interest
expense, net |
|
|
(2,952 |
) |
|
|
(2,596 |
) |
Financing
transaction costs |
|
|
- |
|
|
|
(2,130 |
) |
Adjustments
to fair value of derivatives |
|
|
(90,103 |
) |
|
|
1,679 |
|
Other income
/ (expense), net |
|
|
41 |
|
|
|
(38 |
) |
Income tax
expense |
|
|
(60 |
) |
|
|
(121 |
) |
Net loss
attributable to ordinary shareholders |
|
$ |
(98,921 |
) |
|
$ |
(16,100 |
) |
Net loss per
share attributable to ordinary shareholders – basic and
diluted |
|
$ |
(0.81 |
) |
|
$ |
(1.08 |
) |
Weighted
average ordinary shares outstanding – basic and diluted |
|
|
121,549,083 |
|
|
|
14,868,973 |
|
|
|
|
|
|
Reconciliation of non-GAAP net loss to GAAP net loss |
|
|
|
|
Net loss -
GAAP |
|
$ |
(98,921 |
) |
|
$ |
(16,100 |
) |
Interest
expense - accrued interest and amortization on Exchangeable Notes
and Royalty-Linked Notes |
|
|
2,748 |
|
|
|
2,267 |
|
Financing
transaction costs - not capitalized |
|
|
- |
|
|
|
2,130 |
|
Adjustments
to fair value of derivatives |
|
|
90,103 |
|
|
|
(1,679 |
) |
Non-GAAP net
loss |
|
$ |
(6,070 |
) |
|
$ |
(13,382 |
) |
Net loss per
share attributable to ordinary shareholders – basic and
diluted |
|
$ |
(0.81 |
) |
|
$ |
(1.08 |
) |
Non-GAAP net
loss per share attributable to ordinary shareholders – basic and
diluted |
|
$ |
(0.05 |
) |
|
$ |
(0.90 |
) |
|
|
|
|
|
|
ITERUM
THERAPEUTICS PLC |
Condensed
Consolidated Balance Sheet Data |
(In
thousands) |
(Unaudited) |
|
|
|
|
|
|
|
As of |
|
As of |
|
|
March 31, |
|
December 31, |
|
|
2021 |
|
2020 |
Cash, cash
equivalents and short-term investments |
|
$ |
100,508 |
|
|
$ |
14,508 |
|
Other
assets |
|
|
14,657 |
|
|
|
18,284 |
|
Total assets |
|
$ |
115,165 |
|
|
$ |
32,792 |
|
Long-term
debt, less current portion |
|
$ |
6,094 |
|
|
|
22,462 |
|
Royalty-linked notes, less current portion |
|
|
28,798 |
|
|
|
13,389 |
|
Derivative
liabilities |
|
|
28,868 |
|
|
|
28,865 |
|
Other
liabilities |
|
|
19,888 |
|
|
|
18,635 |
|
Total
liabilities |
|
$ |
83,648 |
|
|
$ |
83,351 |
|
Total
shareholders' equity / (deficit ) |
|
$ |
31,517 |
|
|
$ |
(50,559 |
) |
Total liabilities and shareholders' equity /
(deficit) |
|
$ |
115,165 |
|
|
$ |
32,792 |
|
|
|
|
|
|
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