-Relaunched XENLETA® (lefamulin) and SIVEXTRO® (tedizolid phosphate) in the community with 60 sales representatives-
-Nabriva plans to initiate a Phase 1 clinical trial of XENLETA in patients with cystic fibrosis-
-Conference call today at
“The perseverance and commitment of our team has allowed us to enter 2021 with a clear vision and positive momentum in spite of continued headwinds that COVID-19 has had on the market and our business. In 2020, we shifted our commercial strategy to the community while concurrently obtaining the
CORPORATE AND DEVELOPMENT UPDATES
- On
March 10, 2021 , Nabriva’s Board of Directors electedSteven Gelone , Pharm D, as a member of its Board of Directors, effective immediately.Dr. Gelone has served as Nabriva’s President and Chief Operating Officer sinceJuly 24, 2018 . - On
March 1, 2021 , Nabriva announced that it had entered into a definitive agreement with certain healthcare-focused and institutional investors for the purchase and sale of ordinary shares (or pre-funded warrants in lieu thereof) and warrants in a registered direct offering priced at-the-market under Nasdaq rules for aggregate net proceeds of$23 .4 million, after deducting the placement agent fees and estimated offering expenses. - On
February 26, 2021 , Nabriva announced the appointment ofDaniel Dolan as Chief Financial Officer (CFO), effective at the close of business onMarch 12, 2021 .Mr. Dolan will replace current CFO,Gary Sender , who is retiring from Nabriva.Mr. Sender has agreed to serve as a consultant for Nabriva at least through the remainder of 2021 to support Mr. Dolan’s transition into the CFO role. - On
December 10, 2020 , Nabriva completed a registered public offering in which it sold 6,000,000 ordinary shares. Each share was issued and sold at a public offering price of$2.50 . The net proceeds to Nabriva from the offering, after deducting the placement agent’s fees and offering expenses payable by Nabriva, were$13.3 million . - On
December 7, 2020 , Nabriva announced the restructuring of its license agreement withSinovant Sciences, Ltd. to develop and commercialize XENLETA in the greaterChina region. The restructured agreement provides for additional manufacturing collaboration and regulatory support to be provided to Sinovant by Nabriva that is expected to help expedite the delivery of XENLETA to patients in greaterChina . The restructured agreement also accelerates components of the$5.0 million milestone payment to Nabriva that was previously payable upon regulatory approval of XENLETA inChina , including a payment of$1.0 million which was received in the fourth quarter of 2020. - On
December 2, 2020 , Nabriva filed an Amended and Restated Memorandum and Articles of Association with the Irish Companies Registration Office and effected a one-for-ten reverse stock split of Nabriva’s ordinary shares. As a result of the reverse stock split, every ten ordinary shares in the authorized and unissued and authorized and issued share capital of Nabriva were consolidated into one ordinary share. - On
October 30, 2020 , Nabriva participated in a Type A meeting with theU.S. Food and Drug Administration (FDA) related to the FDA’s pending conduct of inspections of foreign manufacturers during the COVID-19 pandemic that has negatively impacted a number of FDA product reviews, including the CONTEPO™ (fosfomycin for injection) New Drug Application (NDA). The FDA informed Nabriva that it has not yet determined how it will conduct international inspections during the COVID-19 pandemic. As a result, the next steps and specific timing of the CONTEPO NDA resubmission following the complete response letter from the FDA inJune 2020 cannot be finalized until the agency issues industry guidance. Nabriva and others impacted in the industry await future communication from the FDA as it continues to assess the options available under existing regulations and laws to conduct these foreign facility inspections. It is noteworthy that the FDA has not requested any new non-clinical or clinical data and did not raise any other concerns with regard to the safety or efficacy of CONTEPO.
FINANCIAL RESULTS
Three Months Ended
- Revenues increased by
$2.2 million from$0.3 million for the three months endedDecember 31, 2019 to$2.5 million for the three months endedDecember 31, 2020 , primarily due to a$1.8 million increase in collaboration revenue and a$0.3 million increase in research premiums and government grants provided by the Austrian government, offset by a$46 thousand decrease in product revenues, net. Collaboration revenues for the three months endedDecember 31, 2020 include$1.8 million for Nabriva´s share of revenues associated with the SIVEXTRO distribution agreement with Merck & Co., Inc., as well as collaboration revenues associated with the restructuring of the license agreement with Sinovant. For the three months endedDecember 31, 2020 , Nabriva recorded$47 thousand of product revenue, net of gross-to-net accruals. - Research and development expenses decreased by
$2.4 million from$5.2 million for the three months endedDecember 31, 2019 to$2.8 million for the three months endedDecember 31, 2020 . The decrease was primarily due to a$0.7 million decrease in staff costs, a$1.1 million decrease in research materials and purchased services, a$0.2 million decrease in stock-based compensation expense, a$0.1 million decrease in consulting fees, and a$0.3 million decrease in travel and other costs. - Selling, general and administrative expense increased by
$0.4 million from$17.1 million for the three months endedDecember 31, 2019 to$17.5 million for the three months endedDecember 31, 2020 . The increase was primarily due to a$5.3 million increase in commercial consultancy and a reserve for annual manufacturing purchase commitments, a$1.0 million increase in professional fees, a$0.3 million increase in insurance costs, and a$0.3 million increase in infrastructure expenses, partly offset by a$4.8 million decrease in staff costs due to the reduction of headcount, a$0.8 million decrease in stock-based compensation expense and a$0.8 million decrease in travel costs.
Year Ended
- Revenues decreased by
$4.5 million from$9.5 million for the year endedDecember 30, 2019 to$5.0 million for the year endedDecember 31, 2020 , primarily due to a$3.5 million decrease in collaboration revenue and a$1.4 million decrease in product revenue, net, partially offset by a$0.4 million increase in research premiums and government grants provided by the Austrian government. The decrease in collaboration revenues was primarily due to the$5.0 million recognized in 2019 under the Sinovant license agreement, partially offset by$1.8 million recognized in 2020 under the SIVEXTRO distribution agreement with Merck & Co., Inc. - Research and development expenses decreased by
$11.3 million from$26.4 million for the year endedDecember 31, 2019 to$15.1 million for the year endedDecember 31, 2020 . The decrease was primarily due to a$7.2 million decrease in research materials and purchased services related to the development of lefamulin, a$2.9 million decrease in staff costs due to the reduction of employees, a$2.0 million decrease in research consulting fees, a$0.9 million decrease in stock-based compensation expense and$0.4 million decrease in travel expenses, partly offset by a$2.0 million increase in other fees due to a$2.6 million NDA filing fee refund for CONTEPO in 2019. - Selling, general and administrative expense decreased by
$7.2 million from$62.5 million for the year endedDecember 31, 2019 to$55.3 million for the year endedDecember 31, 2020 . The decrease was primarily due to a$4.2 million decrease in staffing expense related to the termination of Nabriva´s sales force in early 2020,$3.7 million decrease in stock-based compensation expense, a$1.6 million decrease in travel expenses, a$0.7 million decrease in advisory and external consultancy expenses primarily related to commercialization activities and professional service fees, and a$0.1 million decrease in other corporate costs, partly offset by a$1.2 million increase in insurance costs and a$1.5 million increase in professional fees. - As previously disclosed, Nabriva’s distribution partners continue to primarily utilize their existing inventory to satisfy product demand for XENLETA, which in turn impacted sales in 2020. In light of the COVID-19 pandemic and the associated disruption to the healthcare industry, future sales amounts in 2021 are uncertain.
- As of
December 31, 2020 , Nabriva had$41.4 million in cash and cash equivalents, compared to$86.0 million as ofDecember 31, 2019 . In addition, Nabriva raised aggregate net proceeds of$23.4 million from itsMarch 2021 financing and from sales under its at-the-market offering program afterDecember 31, 2020 . 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 fourth quarter of 2021. - Nabriva expects to begin selling its own brand of SIVEXTRO early in the second quarter of 2021. At that time, Nabriva will begin to report 100% of SIVEXTRO’s net sales in product revenue, net instead of reporting a percentage of Merck’s gross sales in collaboration revenue.
- Nabriva intends to commence a Phase 1 clinical trial to evaluate the pharmacokinetics, safety and tolerability of XENLETA in individuals with cystic fibrosis. Results from this trial are expected to inform further development of XENLETA as a treatment for staphylococcal lung infections in this population.
Please refer to our Annual Report on Forms 10-K for the fiscal year ended
Company to Host Conference Call
Nabriva’s management will host a conference call today at
About Nabriva Therapeutics plc
About XENLETA
XENLETA (lefamulin) is a first-in-class semi-synthetic pleuromutilin antibiotic for systemic administration in humans discovered and developed by the
Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for
CONTACTS:
For Investors
ir@nabriva.com
For Media
mikebeyer@sambrown.com
312-961-2502
Consolidated Balance Sheets
As of | As of | |||||||
(in thousands, except share data) | ||||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 86,019 | $ | 41,359 | ||||
Restricted cash | 392 | 231 | ||||||
Short-term investments | 175 | 16 | ||||||
Accounts receivable, net and other receivables | 2,744 | 3,909 | ||||||
Inventory | 682 | 5,823 | ||||||
Prepaid expenses | 1,158 | 5,880 | ||||||
Total current assets | 91,170 | 57,218 | ||||||
Property, plant and equipment, net | 2,474 | 768 | ||||||
Intangible assets, net | 91 | 80 | ||||||
Long-term receivables | 378 | 370 | ||||||
Total assets | $ | 94,113 | $ | 58,436 | ||||
Liabilities and stockholders´ equity | ||||||||
Current liabilities: | ||||||||
Current portion of long-term debt | $ | — | $ | 2,041 | ||||
Accounts payable | 4,673 | 2,889 | ||||||
Accrued expense and other current liabilities | 11,966 | 12,844 | ||||||
Deferred revenue | — | 750 | ||||||
Total current liabilities | 16,639 | 18,524 | ||||||
Non-current liabilities | ||||||||
Long-term debt | 34,502 | 5,686 | ||||||
Other non-current liabilities | 1,698 | 1,091 | ||||||
Total non-current liabilities | 36,200 | 6,777 | ||||||
Total liabilities | $ | 52,839 | $ | 25,301 | ||||
Stockholders’ Equity: | ||||||||
Ordinary shares, nominal value |
95 | 211 | ||||||
Preferred shares, par value |
— | — | ||||||
Additional paid in capital | 517,894 | 579,123 | ||||||
Accumulated other comprehensive income | 27 | 27 | ||||||
Accumulated deficit | (476,742 | ) | (546,226 | ) | ||||
Total stockholders’ equity | 41,274 | 33,135 | ||||||
Total liabilities and stockholders’ equity | $ | 94,113 | $ | 58,436 |
Consolidated Statements of Operations
Three Months Ended |
Year Ended |
||||||||||||||||||||||||||||||||
(in thousands, except share and per share data) | 2019 | 2020 | 2019 | 2020 | |||||||||||||||||||||||||||||
Revenues: | |||||||||||||||||||||||||||||||||
Product revenue, net | $ | 93 | $ | 47 | $ | 1,538 | $ | 108 | |||||||||||||||||||||||||
Collaboration revenue | 159 | 1,988 | 6,210 | 2,756 | |||||||||||||||||||||||||||||
Research premium and grant revenue | 81 | 425 | 1,733 | 2,163 | |||||||||||||||||||||||||||||
Total revenue | 333 | 2,460 | 9,481 | 5,027 | |||||||||||||||||||||||||||||
Operating expenses: | |||||||||||||||||||||||||||||||||
Cost of product sales | (55 | ) | (365 | ) | (70 | ) | (766 | ) | |||||||||||||||||||||||||
Research and development expenses | (5,202 | ) | (2,841 | ) | (26,415 | ) | (15,102 | ) | |||||||||||||||||||||||||
Selling, general and administrative expenses | (17,146 | ) | (17,522 | ) | (62,485 | ) | (55,285 | ) | |||||||||||||||||||||||||
Total operating expenses | (22,403 | ) | (20,728 | ) | (88,970 | ) | (71,153 | ) | |||||||||||||||||||||||||
Loss from operations | (22,070 | ) | (18,268 | ) | (79,489 | ) | (66,126 | ) | |||||||||||||||||||||||||
Other income (expense): | |||||||||||||||||||||||||||||||||
Other income (expense), net | 99 | 573 | 215 | 1,187 | |||||||||||||||||||||||||||||
Interest income | 79 | 1 | 255 | 86 | |||||||||||||||||||||||||||||
Interest expense | (1,132 | ) | (199 | ) | (3,644 | ) | (1,735 | ) | |||||||||||||||||||||||||
Loss on extinguishment of debt | — | — | — | (2,757 | ) | ||||||||||||||||||||||||||||
Loss before income taxes | (23,024 | ) | (17,893 | ) | (82,663 | ) | (69,345 | ) | |||||||||||||||||||||||||
Income tax benefit (expense) | (21 | ) | 60 | (101 | ) | (139 | ) | ||||||||||||||||||||||||||
Net loss | $ | (23,045 | ) | $ | (17,833 | ) | $ | (82,764 | ) | $ | (69,484 | ) | |||||||||||||||||||||
Loss per share | |||||||||||||||||||||||||||||||||
Basic and Diluted ($ per share) | $ | (2.87 | ) | $ | (1.11 | ) | $ | (11.15 | ) | $ | (5.41 | ) | |||||||||||||||||||||
Weighted average number of shares: | |||||||||||||||||||||||||||||||||
Basic and Diluted | 8,027,100 | 16,120,089 | 7,419,948 | 12,845,089 |
Condensed Consolidated Statements of Cash Flows
Year Ended |
|||||||||||||
(in thousands) | 2019 | 2020 | |||||||||||
Net cash provided by (used in): | |||||||||||||
Operating activities | $ | (71,892 | ) | $ | (71,331 | ) | |||||||
Investing activities | 331 | (274 | ) | ||||||||||
Financing activities | 56,075 | 26,924 | |||||||||||
Effects of foreign currency translation on cash and cash equivalents | (106 | ) | (140 | ) | |||||||||
Net decrease in cash and cash equivalents | (15,592 | ) | (44,821 | ) | |||||||||
Cash and cash equivalents and restricted cash at beginning of year | 102,003 | 86,411 | |||||||||||
Cash and cash equivalents and restricted cash at end of year | $ | 86,411 | $ | 41,590 |
Source: Nabriva Therapeutics US, Inc