Nabriva Therapeutics Reports Second Quarter 2022 Financial Results and Provides a Corporate Update
-Net Product Sales of
-SIVEXTRO Prescription Demand Grew 28% versus Q2 2021-
-Conference Call Today at
“We continued to accelerate our commercial growth through improved sales execution in the second quarter of 2022. We are seeing significant early success from our increased focus on SIVEXTRO highlighted by the 28% growth in SIVEXTRO prescription demand versus the second quarter of 2021 and a corresponding 25% growth in net product sales during the same period. Our increased focus on and expansion of the targeted call universe for SIVEXTRO has driven our commercial performance by more than doubling our reach to our called-on prescriber targets. The acceleration of SIVEXTRO revenues continues to have a positive impact on our operating leverage.”
CORPORATE AND DEVELOPMENT UPDATES
- On
April 11, 2022 , we announced that the first patient in our Phase 1 clinical trial of XENLETA for the treatment of resistant bacterial infections in patients with Cystic Fibrosis was randomized and dosed. The Phase 1 trial is an open-label, randomized, crossover study to assess the safety and pharmacokinetics following single doses of oral and intravenous XENLETA in adult patients with cystic fibrosis. - On
May 5, 2022 , we announced that we signed an agreement to officially extend our SIVEXTRO Distribution and Promotion Agreement with Merck through at leastDecember 2026 . - On
July 6, 2022 , we announced that we were granted a six-month extension by NASDAQ untilJanuary 2, 2023 , to gain compliance with the$1.00 minimum bid price requirement. - On
July 18, 2022 , we announced our entry into a distribution agreement for XENLETA withEr-Kim Pharmaceuticals pursuant to which Er-Kim licensed from us the rights to distribute XENLETA in the following countries:Bulgaria ,Croatia , Czechia,Greece ,Hungary ,Poland ,Romania ,Slovakia , andSlovenia . Er-Kim also may distribute XENLETA to an additional five countries through a Named Patient Usage (NPU) program. Nabriva will be the exclusive supplier of XENLETA to Er-Kim.
FINANCIAL RESULTS
Three Months Ended
- Revenues for the three months ended
June 30, 2022 were$9.2 million compared to$8.2 million for the three months endedJune 30, 2021 . The$1.0 million increase was primarily due to a$1.6 million increase in SIVEXTRO product revenue, net and a$0.1 million increase in XENLETA product revenue, net, offset by a$0.7 million decrease in collaboration revenues. - Cost of revenues for the three months ended
June 30, 2022 was$4.5 million compared to$3.6 million for the three months endedJune 30, 2021 . The$0.8 million increase was primarily due to SIVEXTRO inventory purchases. Cost of revenues for XENLETA primarily represents direct and indirect manufacturing costs, while cost of revenues for SIVEXTRO represent the actual purchase cost for the finished product from Merck. For the three months endedJune 30, 2022 and 2021, cost of revenues include$37 thousand and$0.2 million , respectively, of a non-cash reserve adjustment for excess and obsolete XENLETA inventory due to timing of expiring inventory. - Research and development expenses for the three months ended
June 30, 2022 were$4.1 million compared to$3.2 million for the three months endedJune 30, 2021 , which represented a 30% increase. The$0.9 million increase was primarily due to a$0.1 million increase in travel expenses, a$0.1 million increase in staff costs, and a$0.7 million increase in research materials and purchased services driven by our Phase 1 cystic fibrosis trial of XENLETA. - Selling, general and administrative expenses for the three months ended
June 30, 2022 were$11.0 million compared to$12.9 million for the three months endedJune 30, 2021 , which represented a 14% decrease. The$1.8 million decrease was primarily due to a$2.1 million decrease in advisory and external consultancy expenses primarily related to commercialization activities, offset by a$0.1 million increase in travel expenses, and a$0.2 million increase in infrastructure costs. - Net loss decreased by
$0.7 million from a$11.8 million net loss for the three months endedJune 30, 2021 to a$11.1 million net loss for the three months endedJune 30, 2022 .
Six Months Ended
- Revenues for the six months ended
June 30, 2022 were$17.2 million compared to$10.8 million for the six months endedJune 30, 2021 . The$6.4 million increase was primarily due to a$8.8 million increase in SIVEXTRO product revenue, net for the six months endedJune 30, 2022 , partly offset by a$2.1 million decrease in collaboration revenues and a$0.2 million decrease in XENLETA product revenue, net. - Cost of revenues for the six months ended
June 30, 2022 was$7.8 million compared to$3.7 million for the six months endedJune 30, 2021 . The$4.1 million increase was primarily due to SIVEXTRO cost, which were not incurred prior to the launch of our own SIVEXTRO National Drug Code onApril 12, 2021 . Cost of revenues for XENLETA primarily represents direct and indirect manufacturing costs, while cost of revenues for SIVEXTRO represent the actual purchase cost for the finished product from Merck. For the six months endedJune 30, 2022 and 2021, cost of revenues include$0.1 million and$0.2 million , respectively, of a non-cash reserve adjustment for excess and obsolete XENLETA inventory due to timing of expiring inventory. - Research and development expenses for the six months ended
June 30, 2022 were$7.6 million compared to$7.0 million for the six months endedJune 30, 2021 , which represented an 8% increase. The$0.6 million increase was primarily due to a$0.5 million increase in research materials driven by our Phase 1 cystic fibrosis trial of XENLETA and purchased services, and a$0.1 million increase in travel expenses. - Selling, general and administrative expenses for the six months ended
June 30, 2022 were$23.7 million compared to$24.9 million for the six months endedJune 30, 2021 , which represented a 5% decrease. The$1.2 million decrease was primarily due to a$2.1 million decrease in advisory and external consultancy expenses primarily related to commercialization activities, a$0.8 million increase in staff costs, and a$0.1 million increase in travel expenses. - Net loss decreased by
$2.8 million from a$25.7 million net loss for the six months endedJune 30, 2021 , to a$22.9 million net loss for the six months endedJune 30, 2022 . - As of
June 30, 2022 , Nabriva had$20.2 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 substantially through the fourth quarter of 2022.
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 SIVEXTRO
SIVEXTRO (tedizolid phosphate) was approved by the
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
CONTACT:
For Investors and Media
Nabriva Therapeutics plc
ir@nabriva.com
Consolidated Balance Sheets (unaudited)
As of | As of | |||||||
(in thousands, except share data) | ||||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 20,041 | $ | 47,659 | ||||
Restricted cash | 122 | 175 | ||||||
Short-term investments | — | 16 | ||||||
Accounts receivable, net and other receivables | 12,361 | 12,751 | ||||||
Inventory | 15,535 | 14,509 | ||||||
Prepaid expenses | 6,237 | 5,155 | ||||||
Total current assets | 54,296 | 80,265 | ||||||
Property and equipment, net | 206 | 233 | ||||||
Intangible assets, net | 13 | 31 | ||||||
Other non-current assets | 378 | 380 | ||||||
Total assets | $ | 54,893 | $ | 80,909 | ||||
Liabilities and stockholders´ equity | ||||||||
Current liabilities: | ||||||||
Current portion of long-term debt | $ | 6,624 | $ | 3,765 | ||||
Accounts payable | 1,073 | 4,372 | ||||||
Accrued expense and other current liabilities | 11,635 | 13,829 | ||||||
Deferred revenue | — | 374 | ||||||
Total current liabilities | 19,332 | 22,340 | ||||||
Non-current liabilities: | ||||||||
Long-term debt | 512 | 4,265 | ||||||
Other non-current liabilities | 444 | 954 | ||||||
Total non-current liabilities | 956 | 5,219 | ||||||
Total liabilities | 20,288 | 27,559 | ||||||
Stockholders’ Equity: | ||||||||
Ordinary shares, nominal value |
646 | 567 | ||||||
Preferred shares, par value |
— | — | ||||||
Additional paid in capital | 652,501 | 648,432 | ||||||
Accumulated other comprehensive income | 27 | 27 | ||||||
Accumulated deficit | (618,569 | ) | (595,676 | ) | ||||
Total stockholders’ equity | 34,605 | 53,350 | ||||||
Total liabilities and stockholders’ equity | $ | 54,893 | $ | 80,909 |
Consolidated Statements of Operations (unaudited)
Three Months Ended | Six Months Ended | |||||||||||||||
(in thousands, except share and per share data) | 2022 | 2021 | 2022 | 2021 | ||||||||||||
Revenues: | ||||||||||||||||
Product revenue, net | $ | 8,680 | $ | 6,940 | $ | 15,720 | $ | 7,070 | ||||||||
Collaboration revenue | 96 | 813 | 725 | 2,815 | ||||||||||||
Research premium and grant revenue | 415 | 490 | 766 | 887 | ||||||||||||
Total revenues | 9,191 | 8,243 | 17,211 | 10,772 | ||||||||||||
Operating expenses: | ||||||||||||||||
Cost of revenues | (4,455 | ) | (3,621 | ) | (7,816 | ) | (3,683 | ) | ||||||||
Research and development expenses | (4,088 | ) | (3,150 | ) | (7,605 | ) | (7,018 | ) | ||||||||
Selling, general and administrative expenses | (11,047 | ) | (12,854 | ) | (23,747 | ) | (24,901 | ) | ||||||||
Total operating expenses | (19,590 | ) | (19,625 | ) | (39,168 | ) | (35,602 | ) | ||||||||
Loss from operations | (10,399 | ) | (11,382 | ) | (21,957 | ) | (24,830 | ) | ||||||||
Other income (expense): | ||||||||||||||||
Other income (expense), net | (92 | ) | 470 | 216 | 348 | |||||||||||
Interest income (expense), net | (198 | ) | (236 | ) | (413 | ) | (457 | ) | ||||||||
Loss before income taxes | (10,689 | ) | (11,148 | ) | (22,154 | ) | (24,939 | ) | ||||||||
Income tax expense | (385 | ) | (606 | ) | (739 | ) | (796 | ) | ||||||||
Net loss | $ | (11,074 | ) | $ | (11,754 | ) | $ | (22,893 | ) | $ | (25,735 | ) | ||||
Loss per share | ||||||||||||||||
Basic and diluted ($ per share) | $ | (0.18 | ) | $ | (0.29 | ) | $ | (0.38 | ) | $ | (0.77 | ) | ||||
Weighted average number of shares: | ||||||||||||||||
Basic and diluted | 63,238,080 | 40,573,848 | 61,028,388 | 33,532,837 |
Condensed Consolidated Statements of Cash Flows (unaudited)
Six Months Ended | ||||||||
(in thousands) | 2022 | 2021 | ||||||
Net cash provided by (used in): | ||||||||
Operating activities | $ | (28,909 | ) | $ | (40,200 | ) | ||
Investing activities | (152 | ) | (69 | ) | ||||
Financing activities | 1,402 | 60,156 | ||||||
Effects of exchange rate changes on the balance of cash held in foreign currencies | (12 | ) | (157 | ) | ||||
Net increase (decrease) in cash and cash equivalents and restricted cash | (27,671 | ) | 19,730 | |||||
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 | $ | 20,163 | $ | 61,320 |

Source: Nabriva Therapeutics US, Inc