UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

 

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): March 12, 2020

 

Iterum Therapeutics plc

(Exact name of registrant as specified in its charter)

Ireland

001-38503

98-1283148

(State or other jurisdiction

(Commission File Number)

(IRS Employer Identification No.)

of incorporation)

 

 

 

 

 

 

Block 2 Floor 3, Harcourt Centre,

Harcourt Street,

Dublin 2, Ireland


 

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: +353 1 903 8920

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

☐ 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 

☐ 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Securities registered pursuant to Section 12 (b) of the Act:

 

Title of Each Class

Trading Symbol

Name of Each Exchange on Which Registered

Ordinary Shares, par value $0.01 per share

ITRM

The Nasdaq Stock Market LLC

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.


 

Item 2.02. Results of Operations and Financial Condition.

On March 12, 2020, Iterum Therapeutics plc (“Iterum Therapeutics”) issued a press release announcing its financial results for the fourth quarter and year ended December 31, 2019. A copy of the press release is furnished herewith as Exhibit 99.1.

The information in this current report on Form 8-K, including the press release attached as Exhibit 99.1 hereto, is being furnished, but shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained herein and in the accompanying exhibit shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by Iterum Therapeutics, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

 

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 the related per share measure) to exclude from reported GAAP net loss (and the related per share measure) for the fourth quarter and year ended December 31, 2018 the $7.5 million clinical milestone payment made to Pfizer on first patient dosing with sulopenem IV and $15.0 million in clinical milestone payments made to Pfizer on first patient dosing with oral sulopenem ($7.5 million) and on first patient dosing with sulopenem IV ($7.5 million), respectively. Iterum Therapeutics believes that the presentation of non-GAAP adjusted net loss, 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. This non-GAAP measure closely aligns with the way management measures and evaluates Iterum Therapeutics’ performance. This non-GAAP financial measure 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 is 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 $7.5 million clinical milestone payment and $15.0 million in clinical milestone payments to Pfizer for the fourth quarter and year ended December 31, 2018, respectively. Because of the non-standardized definitions of non-GAAP financial measures, Non-GAAP adjusted net loss 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 has been provided in the tables included in the accompanying press release.

 

Item 9.01Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit No.    Description

99.1  Press Release of Iterum Therapeutics plc, dated March 12, 2020


SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

Iterum Therapeutics plc

 

 

 

Dated: March 12, 2020

 

 

 

 

By:

  /s/ Corey Fishman

 

 

 

 

Corey N. Fishman

 

 

 

Chief Executive Officer

 

 

Iterum Therapeutics (NASDAQ:ITRM)
Historical Stock Chart
From Jun 2020 to Jul 2020 Click Here for more Iterum Therapeutics Charts.
Iterum Therapeutics (NASDAQ:ITRM)
Historical Stock Chart
From Jul 2019 to Jul 2020 Click Here for more Iterum Therapeutics Charts.