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0001641640false00-00000000000000016416402022-11-102022-11-10

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): November 10, 2022

NABRIVA THERAPEUTICS PLC

(Exact name of registrant as specified in its charter)

Ireland

001-37558

Not Applicable

(State or other jurisdiction of incorporation)

(Commission File Number)

(I.R.S. Employer Identification No.)

25-28 North Wall Quay,

IFSC, Dublin 1, Ireland

Not Applicable

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (610) 816-6640

Not Applicable

(Former name or former address, if changed since last report.)

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))

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

Title of each class

Trading Symbol(s)

Name of each exchange on which
registered

Ordinary Shares, nominal value $0.01 per share

    

NBRV

    

The Nasdaq Capital Market

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 Conditions.

On November 10, 2022, Nabriva Therapeutics plc issued a press release announcing its consolidated financial results for the quarter ended September 30, 2022. The full text of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The information in this Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01. Financial Statements and Exhibits.

(d)     Exhibits

The following exhibit relating to Item 2.02 shall be deemed to be furnished and not filed:

Exhibit 99.1

    

Press release issued by Nabriva Therapeutics plc, dated November 10, 2022

Exhibit 104

Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101)

SIGNATURES

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

NABRIVA THERAPEUTICS PLC

Date: November 10, 2022

By:

/s/ Daniel Dolan

Daniel Dolan

Chief Financial Officer

Exhibit 99.1

Graphic

Nabriva Therapeutics Pivoting Strategic Focus

Reports Third Quarter Financial Results and Provides Corporate Update

-Shifted Focus to SIVEXTRO to Enable Cost Cutting-

-Cash Runway Extended into Q1 2023-

-Q3 2022 Total Revenue of $9.2 Million-

-Engaged Torreya Capital As Strategic Advisor-

-Conference call today at 4:30 p.m. Eastern Time-

Dublin Ireland, November 10, 2022Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, today announced it has pivoted its strategic focus towards commercialization efforts, primarily focused on SIVEXTRO, to extend its cash runway, while exploring strategic options. Nabriva also issued financial results for the three months ended September 30, 2022.

“Given the pressures of the macro environment, we believe building on our commercial success with SIVEXTRO, as demonstrated by the continued prescription demand growth, is the most efficient and effective way to extend our cash runway and preserve optionality and value for our shareholders” said Ted Schroeder, Nabriva’s CEO.

Mr. Schroeder continued, “Aligned with the shift in our strategic focus, we have suspended early-stage research and development activities and reduced global headcount by approximately 40% as part of the broader initiative to extend our cash runway and maximize the value of the products in our portfolio. As such, we have engaged Torreya Capital to help us explore strategic options.”

Torreya Capital will advise Nabriva on its exploration of a range of strategic options, which could include the potential in-licensing or out-licensing of commercial stage assets. This process may not result in any transaction, and the Company does not intend to disclose additional details unless and until it has entered into a specific transaction.

Corporate and Development Updates

On August 11, 2022, we announced the completion of enrollment in our Phase 1 clinical trial of XENLETA as potential treatment of resistant bacterial infections in patients with Cystic Fibrosis. The Phase 1 trial is an open label, randomized, crossover study to assess the safety and pharmacokinetics following singled doses of oral and intravenous XENLETA in adult patients with Cystic Fibrosis.


On September 15, 2022, we announced a 1-for-25 reverse stock split which was necessary for us to regain compliance with the minimum $1.00 per share requirement pursuant to Nasdaq Listing Rule 5450(a)(1) (Bid Price Rule). We were notified by Nasdaq on September 30, 2022 that we had regained compliance with the Bid Price Rule.

Financial results

Three Months Ended September 30, 2022 and 2021

Revenues for the three months ended September 30, 2022 were $9.2 million compared to $8.9 million for the three months ended September 30, 2021. The $0.3 million increase was driven by an increase in product revenue, net, offset by a decrease in collaboration revenues.

Cost of revenues for the three months ended September 30, 2022 was $4.4 million compared to $4.2 million for the three months ended September 30, 2021. The $0.2 million increase was primarily due to SIVEXTRO costs, which were not incurred prior to the launch of our own SIVEXTRO New Drug Code (NDC) in April 2021.

Research and development expenses for the three months ended September 30, 2022 were $4.0 million compared to $3.2 million for the three months ended September 30, 2021. The $0.8 million increase was primarily due to a $0.5 million increase in consulting fees and a $0.4 million increase in research materials and purchased services driven by our Phase 1 trial to assess the safety and pharmacokinetics of oral and intravenous XENLETA for the treatment of resistant bacterial infections in adult patients with cystic fibrosis.

Selling, general and administrative expenses for the three months ended September 30, 2022 were $11.9 million compared to $12.3 million for the three months ended September 30, 2021. The $0.3 million decrease was driven by a decrease in personnel costs and a decrease in stock-based compensation expenses.

Net loss increased by $0.9 million from a $10.7 million net loss for the three months ended September 30, 2021 to a $11.5 million net loss for the three months ended September 30, 2022.

Nine Months Ended September 30, 2022 and 2021

Revenues for the nine months ended September 30, 2022 were $26.4 million compared to $19.6 million for the nine months ended September 30, 2021. The $6.7 million increase was primarily due to a $8.6 million increase in SIVEXTRO product revenue, net, partly offset by a $2.5 million decrease in collaboration revenues.

Cost of revenues for the nine months ended September 30, 2022 was $12.2 million compared to $7.9 million for the nine months ended September 30, 2021. The $4.3 million increase was primarily due to SIVEXTRO costs, which were not incurred prior to the launch of our own SIVEXTRO NDC on April 12, 2021.

Research and development expenses for the nine months ended September 30, 2022 were $11.6 million compared to $10.2 million for the nine months ended September 30, 2021. The $1.4 million

increase was primarily due to a $0.9 million increase in research materials and purchased services driven by our Phase 1 trial to assess the safety and pharmacokinetics of oral and intravenous XENLETA for the treatment of resistant bacterial infections in adult patients with cystic fibrosis, and a $0.4 million increase in advisory and external consultancy expenses.

Selling, general and administrative expenses for the nine months ended September 30, 2022 were $35.7 million compared to $37.2 million for the nine months ended September 30, 2021. The $1.5 million decrease was primarily due to a decrease in advisory and external consultancy expenses.

Net loss decreased by $2.0 million from a $36.4 million net loss for the nine months ended September 30, 2021 to a $34.4 million net loss for the nine months ended September 30, 2022.

As of September 30, 2022, Nabriva had $14.8 million in cash, cash equivalents and restricted cash. Based on its current operating plans, Nabriva expects that its existing cash resources will be sufficient to enable it to fund its operating expenses, debt service obligations and capital expenditure requirements into the first quarter of 2023.

Please refer to our Annual Report on Forms 10-K for the fiscal year ended December 31, 2021 and our Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2022 filed with the U.S. Securities and Exchange Commission, for additional information regarding the Company’s business and financial results.  

Company to Host Conference Call

Nabriva’s management will host a conference call today at 4:30 p.m. ET to discuss the financial results and recent corporate highlights. The dial-in number for the conference call is (833) 634-2311 for domestic participants and (412) 902-4177 for international participants and ask to join the “Nabriva Therapeutics Conference Call.” A live webcast of the conference call can be accessed through the “Investors” tab on the Nabriva Therapeutics website at www.nabriva.com. A replay will be available on this website shortly after conclusion of the event for 90 days.

About Nabriva Therapeutics plc

Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections. Nabriva entered into an exclusive agreement with subsidiaries of Merck & Co. Inc., Kenilworth, N.J., USA to market, sell and distribute SIVEXTRO® (tedizolid phosphate) in the United States and certain of its territories. Nabriva Therapeutics received U.S. Food and Drug Administration approval for XENLETA® (lefamulin injection, lefamulin tablets), the first systemic pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP). Nabriva Therapeutics is also developing CONTEPO™ (fosfomycin) for injection, a potential first-in-class epoxide antibiotic for complicated urinary tract infections (cUTI), including acute pyelonephritis.

About SIVEXTRO

SIVEXTRO (tedizolid phosphate) was approved by the U.S. Food and Drug Administration in 2014. It is indicated in adults and pediatric patients 12 years of age and older for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-resistant (MRSA) and methicillin-


susceptible (MSSA) isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus group (including Streptococcus anginosus, Streptococcus intermedius and Streptococcus constellatus), and Enterococcus faecalis. To reduce the development of drug-resistant bacteria and maintain the effectiveness of SIVEXTRO and other antibacterial drugs, SIVEXTRO should be used only to treat ABSSSI that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

About XENLETA

XENLETA (lefamulin) is a first-in-class semi-synthetic pleuromutilin antibiotic for systemic administration in humans discovered and developed by the Nabriva Therapeutics team. It is designed to inhibit the synthesis of bacterial protein, which is required for bacteria to grow. XENLETA’s binding occurs with high affinity, high specificity and at molecular sites that are different than other antibiotic classes. Efficacy of XENLETA was demonstrated in two multicenter, multinational, double-blind, double-dummy, non-inferiority trials assessing a total of 1,289 patients with CABP. In these trials, XENLETA was compared with moxifloxacin and in one trial, moxifloxacin with and without linezolid. Patients who received XENLETA had similar rates of efficacy as those taking moxifloxacin alone or moxifloxacin plus linezolid. The most common adverse reactions associated with XENLETA included diarrhea, nausea, reactions at the injection site, elevated liver enzymes, and vomiting. For more information, please visit www.XENLETA.com.

Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for Nabriva Therapeutics, including but not limited to statements about its ability to successfully commercialize XENLETA for the treatment of CABP, including the managed care coverage for XENLETA, the distribution and promotion of SIVEXTRO for the treatment of ABSSSI, the development of CONTEPO for Complicated Urinary Tract Infections (cUTI), the clinical utility of XENLETA for CABP and Cystic Fibrosis, SIVEXTRO for ABSSSI and of CONTEPO for cUTI, the impact of macro events on sales of SIVEXTRO and XENLETA, plans for and timing of the review of regulatory filings for XENLETA and CONTEPO, efforts to bring CONTEPO to market, the market opportunity for and the potential market acceptance of XENLETA for CABP, SIVEXTRO for ABSSSI and CONTEPO for cUTI, the prospects for future sales of SIVEXTRO, the development of XENLETA and CONTEPO for additional indications, plans to pursue research and development of other product candidates, plans to pursue business development initiatives, expectations regarding the impact of the interruptions resulting from COVID-19 on its business, the sufficiency of Nabriva Therapeutics’ existing cash resources and its expectations regarding anticipated revenues from product sales and how far into the future its existing cash resources will fund its ongoing operations and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “likely,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: Nabriva Therapeutics’ ability to successfully execute its commercialization plans for SIVEXTRO and whether market demand for SIVEXTRO is consistent with its expectations, Nabriva Therapeutics’ ability to build and maintain a sales force for SIVEXTRO, the content and timing of decisions made by the U.S. Food and Drug Administration and other regulatory authorities, the uncertainties inherent in the initiation and conduct of clinical trials,


availability and timing of data from clinical trials, whether results of early clinical trials or studies in different disease indications will be indicative of the results of ongoing or future trials, uncertainties associated with regulatory review of clinical trials and applications for marketing approvals, the availability or commercial potential of CONTEPO for the treatment of cUTI, the extent of business interruptions resulting from the infection causing the COVID-19 outbreak or similar public health crises, the ability to retain and hire key personnel, the availability of adequate additional financing on acceptable terms or at all and such other important factors as are set forth in Nabriva Therapeutics’ annual and quarterly reports and other filings on file with the U.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Nabriva Therapeutics’ views as of the date of this press release. Nabriva Therapeutics anticipates that subsequent events and developments will cause its views to change. However, while Nabriva Therapeutics may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Nabriva Therapeutics’ views as of any date subsequent to the date of this press release.

CONTACT:

For Investors and Media

Kim Anderson

Nabriva Therapeutics plc

ir@nabriva.com


Consolidated Balance Sheets (unaudited)

As of

As of

(in thousands, except share data)

    

September 30, 2022

    

December 31, 2021

Assets

 

  

 

  

Current assets:

 

  

 

  

Cash and cash equivalents

$

14,647

$

47,659

Restricted cash

121

175

Short-term investments

 

 

16

Accounts receivable, net and other receivables

12,388

12,751

Inventory

17,333

14,509

Prepaid expenses

 

3,074

 

5,155

Total current assets

 

47,563

 

80,265

Property and equipment, net

 

293

 

233

Intangible assets, net

 

7

 

31

Other non-current assets

 

377

 

380

Total assets

$

48,240

$

80,909

Liabilities and stockholders´ equity

 

 

Current liabilities:

 

 

Current portion of long-term debt

$

5,733

$

3,765

Accounts payable

3,895

4,372

Accrued expense and other current liabilities

 

12,012

 

13,829

Deferred revenue

374

Total current liabilities

 

21,640

 

22,340

Non-current liabilities:

Long-term debt

399

4,265

Other non-current liabilities

 

578

 

954

Total non-current liabilities

977

5,219

Total liabilities

22,617

27,559

Stockholders’ Equity:

 

 

Ordinary shares, nominal value $0.01, 12,000,000 ordinary shares authorized at September 30, 2022; 3,021,368 and 2,268,612 issued and outstanding at September 30, 2022, and December 31, 2021, respectively

30

23

Preferred shares, par value $0.01, 100,000,000 shares authorized at September 30, 2022; None issued and outstanding

Additional paid in capital

 

655,649

 

648,976

Accumulated other comprehensive income

 

27

 

27

Accumulated deficit

 

(630,083)

 

(595,676)

Total stockholders’ equity

25,623

 

53,350

Total liabilities and stockholders’ equity

$

48,240

$

80,909


Consolidated Statements of Operations (unaudited)

Three Months Ended

Nine Months Ended

September 30,

September 30,

(in thousands, except share and per share data)

    

2022

    

2021

    

2022

    

2021

Revenues:

 

  

 

  

 

Product revenue, net

$

8,643

$

7,858

$

24,363

$

14,928

Collaboration revenue

141

562

866

3,377

Research premium and grant revenue

369

442

1,135

1,329

Total revenues

9,153

8,862

26,364

19,634

Operating expenses:

 

 

 

 

Cost of revenues

(4,416)

(4,199)

(12,232)

(7,882)

Research and development expenses

(4,032)

(3,221)

(11,637)

(10,239)

Selling, general and administrative expenses

 

(11,907)

 

(12,256)

 

(35,654)

 

(37,157)

Total operating expenses

(20,355)

(19,676)

(59,523)

(55,278)

Loss from operations

(11,202)

(10,814)

(33,159)

(35,644)

Other income (expense):

 

 

 

 

Other income, net

 

354

 

131

 

570

 

479

Interest expense, net

 

(146)

 

(221)

 

(559)

 

(678)

Loss before income taxes

(10,994)

(10,904)

(33,148)

(35,843)

Income tax benefit (expense)

 

(520)

 

252

 

(1,259)

 

(544)

Net loss

$

(11,514)

$

(10,652)

$

(34,407)

$

(36,387)

Loss per share

Basic and diluted ($ per share)

$

(4.21)

$

(5.27)

$

(13.55)

$

(23.17)

Weighted average number of shares:

 

 

Basic and diluted

2,732,749

2,021,070

 

2,539,408

 

1,570,389


Condensed Consolidated Statements of Cash Flows (unaudited)

Nine Months Ended

September 30,

(in thousands)

    

2022

    

2021

 

Net cash provided by (used in):

Operating activities

$

(35,086)

$

(53,439)

Investing activities

(256)

(69)

Financing activities

2,510

64,228

Effects of exchange rate changes on the balance of cash held in foreign currencies

(234)

(136)

Net increase (decrease) in cash and cash equivalents and restricted cash

(33,066)

10,584

Cash and cash equivalents and restricted cash at beginning of period

47,834

41,590

Cash and cash equivalents and restricted cash at end of period

$

14,768

$

52,174