-First quarter of full complement of 60 sales representatives further expanding the reach of XENLETA® (lefamulin) and SIVEXTRO® (tedizolid phosphate) in the community-
-Commenced exclusive distribution of SIVEXTRO in the
-Conference call today at
“Our commercial efforts continue to accelerate, strengthening awareness and laying the groundwork for prescription growth for both SIVEXTRO and XENLETA in the community. In spite of a dramatic reduction in influenza-like illnesses to historical lows as a result of the impact of COVID-19 hygienic protocols, we are especially encouraged by the trends we have recently seen in our ability to increase call frequency, especially the significant increase in face-to-face interactions with health care providers which has increased 14% in the last 2 months to 64%,” said
CORPORATE AND DEVELOPMENT UPDATES
- On
April 12, 2021 , Nabriva began exclusive distribution of SIVEXTRO under the Nabriva National Drug Code and will recognize 100% of net product sales and related cost of product sales of SIVEXTRO in its results of operations beginning onApril 12, 2021 . Going forward, the company expects an improvement in profitability as a result of launching its own NDC. Nabriva expects to record gross sales that are approximately a mid to high single digit multiple of the previously recorded collaboration revenue. These gross sales would then be subject to the standard gross-to-net deductions to arrive at a reported net sales number. - On
April 5, 2021 , theFood and Drug Administration (FDA) granted Nabriva an extension for the re-submission of the New Drug Application for CONTEPO with the FDA toJune 19, 2022 . The extension of the re-submission timeline was granted due to the ongoing COVID-related travel restrictions that have impacted the Agency’s ability to conduct onsite inspections of foreign manufacturing facilities. The extension provides the Agency adequate time to assess the application of the recently issued guidance entitled “Remote Interactive Evaluations for Oversight of Drug Facilities During COVID-19” to the CONTEPO re-submission. - On
March 10, 2021 , Nabriva’s Board of Directors electedSteven Gelone , Pharm D, as a member of its Board of Directors.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 offering expenses. - On
February 26, 2021 , Nabriva announced the appointment ofDaniel Dolan as Chief Financial Officer (CFO), effective as of the close of business onMarch 12, 2021 .Mr. Dolan replacedGary Sender who retired from Nabriva.Mr. Sender has agreed to serve as a consultant to Nabriva at least through the remainder of 2021 to support Mr. Dolan’s transition into the CFO role.
FINANCIAL RESULTS
Three Months Ended
- Revenues increased by
$1.7 million from$0.8 million for the three months endedMarch 31, 2020 to$2.5 million for the three months endedMarch 31, 2021 , primarily due to an increase of$1.9 million of collaboration revenues for the three months endedMarch 31, 2021 which includes$0.7 million related to the restructured license agreement with Sinovant, which is being recognized over the estimated period the manufacturing collaboration and regulatory support will be provided to Sinovant, as well as$1.0 million of our share of revenues associated with the SIVEXTRO distribution agreement. - Research and development expenses decreased by
$1.1 million from$4.9 million for the three months endedMarch 31, 2020 to$3.9 million for the three months endedMarch 31, 2021 . The decrease was primarily due to a$0.3 million decrease in stock-based compensation expense, a$0.6 million decrease in staff costs, a$0.2 million decrease in research materials and purchased services, and a$0.1 million decrease in travel costs. - Selling, general and administrative expense decreased by
$4.0 million from$16.0 million for the three months endedMarch 31, 2020 to$12.0 million for the three months endedMarch 31, 2021 . The decrease was primarily due to a$4.8 million decrease in staff costs due to the reduction of headcount, a$0.6 million decrease in stock-based compensation expense, a$0.7 million decrease in travel costs, a$0.5 million decrease in professional fees partly offset by a$2.5 million increase in advisory and external consultancy expenses primarily related to commercialization activities and professional service fees. - Interest expense decreased
$0.8 million from$1.0 million for the three months endedMarch 31, 2020 to$0.2 million for the three months endedMarch 31, 2021 , driven by the repayment of$30.0 million of debt to Hercules during the three months endedMarch 31, 2020 . Nabriva also recorded a one-time non-cash$2.7 million loss during the three months endedMarch 31, 2020 on the extinguishment resulting from the prepayment. - Net operating loss decreased
$9.3 million from a$23.3 million loss for the three months endedMarch 31, 2020 , compared to a$14.0 million loss for the three months endedMarch 31, 2021 . - As of
March 31, 2021 , Nabriva had$54.8 million in cash and cash equivalents. 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.
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
About SIVEXTRO
SIVEXTRO (tedizolid phosphate) was approved 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
andrea.greif@ogilvy.com
914-772-3027
Consolidated Balance Sheets
As of | As of | |||||||
(in thousands, except share data) | ||||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 41,359 | $ | 54,788 | ||||
Restricted cash | 231 | 230 | ||||||
Short-term investments | 16 | 16 | ||||||
Accounts receivable, net and other receivables | 3,909 | 4,206 | ||||||
Inventory | 5,823 | 8,974 | ||||||
Prepaid expenses | 5,880 | 10,225 | ||||||
Total current assets | 57,218 | 78,439 | ||||||
Property, plant and equipment, net | 768 | 521 | ||||||
Intangible assets, net | 80 | 65 | ||||||
Other non-current assets | 370 | 383 | ||||||
Total assets | $ | 58,436 | $ | 79,408 | ||||
Liabilities and stockholders´ equity | ||||||||
Current liabilities: | ||||||||
Current portion of long-term debt | $ | 2,041 | $ | 2,621 | ||||
Accounts payable | 2,889 | 3,636 | ||||||
Accrued expense and other current liabilities | 12,844 | 11,292 | ||||||
Deferred revenue | 750 | 750 | ||||||
Total current liabilities | 18,524 | 18,299 | ||||||
Non-current liabilities | ||||||||
Long-term debt | 5,686 | 5,177 | ||||||
Other non-current liabilities | 1,091 | 941 | ||||||
Total non-current liabilities | 6,777 | 6,118 | ||||||
Total liabilities | $ | 25,301 | $ | 24,417 | ||||
Stockholders’ Equity: | ||||||||
Ordinary shares, nominal value |
211 | 354 | ||||||
Preferred shares, par value |
— | — | ||||||
Additional paid in capital | 579,123 | 614,817 | ||||||
Accumulated other comprehensive income | 27 | 27 | ||||||
Accumulated deficit | (546,226 | ) | (560,207 | ) | ||||
Total stockholders’ equity | 33,135 | 54,991 | ||||||
Total liabilities and stockholders’ equity | $ | 58,436 | $ | 79,408 | ||||
Consolidated Statements of Operations
Three Months Ended |
||||||||||
(in thousands, except share and per share data) | 2020 | 2021 | ||||||||
Revenues: | ||||||||||
Product revenue, net | $ | 156 | $ | 130 | ||||||
Collaboration revenue | 145 | 2,002 | ||||||||
Research premium and grant revenue | 488 | 397 | ||||||||
Total revenue | 789 | 2,529 | ||||||||
Operating expenses: | ||||||||||
Cost of product sales | (8 | ) | (62 | ) | ||||||
Research and development expenses | (4,944 | ) | (3,868 | ) | ||||||
Selling, general and administrative expenses | (16,025 | ) | (12,047 | ) | ||||||
Total operating expenses | (20,977 | ) | (15,977 | ) | ||||||
Loss from operations | (20,188 | ) | (13,448 | ) | ||||||
Other income (expense): | ||||||||||
Other income (expense), net | 798 | (122 | ) | |||||||
Interest income | 64 | 1 | ||||||||
Interest expense | (1,024 | ) | (222 | ) | ||||||
Loss on extinguishment of debt | (2,757 | ) | — | |||||||
Loss before income taxes | (23,107 | ) | (13,791 | ) | ||||||
Income tax expense | (152 | ) | (190 | ) | ||||||
Net loss | $ | (23,259 | ) | $ | (13,981 | ) | ||||
Loss per share | ||||||||||
Basic and Diluted ($ per share) | $ | (2.46 | ) | $ | (0.53 | ) | ||||
Weighted average number of shares: | ||||||||||
Basic and Diluted | 9,459,515 | 26,413,590 | ||||||||
Condensed Consolidated Statements of Cash Flows
Three Months Ended |
||||||||
(in thousands) | 2020 | 2021 | ||||||
Net cash provided by (used in): | ||||||||
Operating activities | $ | (28,108 | ) | $ | (21,626 | ) | ||
Investing activities | (20 | ) | (120 | ) | ||||
Financing activities | (30,219 | ) | 34,930 | |||||
Effects of exchange rate changes on the balance of cash held in foreign currencies | (682 | ) | 244 | |||||
Net decrease (increase) in cash and cash equivalents and restricted cash | (59,029 | ) | 13,428 | |||||
Cash and cash equivalents and restricted cash at beginning of quarter | 86,411 | 41,590 | ||||||
Cash and cash equivalents and restricted cash at end of quarter | $ | 27,382 | $ | 55,018 |
Source: Nabriva Therapeutics US, Inc