Nabriva Therapeutics Reports Fourth Quarter and Year End 2020 Financial Results and Provides Corporate Updates
-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
March 10, 2021, Nabriva’s Board of Directors elected Steven Gelone, Pharm D, as a member of its Board of Directors, effective immediately. Dr. Gelonehas served as Nabriva’s President and Chief Operating Officer since July 24, 2018.
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.
February 26, 2021, Nabriva announced the appointment of Daniel Dolanas Chief Financial Officer (CFO), effective at the close of business on March 12, 2021. Mr. Dolanwill replace current CFO, Gary Sender, who is retiring from Nabriva. Mr. Senderhas 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.
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.
December 7, 2020, Nabriva announced the restructuring of its license agreement with Sinovant Sciences, Ltd.to develop and commercialize XENLETA in the greater Chinaregion. 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 greater China. The restructured agreement also accelerates components of the $5.0 millionmilestone payment to Nabriva that was previously payable upon regulatory approval of XENLETA in China, including a payment of $1.0 millionwhich was received in the fourth quarter of 2020.
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.
October 30, 2020, Nabriva participated in a Type A meeting with the U.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 in June 2020cannot 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.
Three Months Ended
- Revenues increased by
$2.2 millionfrom $0.3 millionfor the three months ended December 31, 2019to $2.5 millionfor the three months ended December 31, 2020, primarily due to a $1.8 millionincrease in collaboration revenue and a $0.3 millionincrease in research premiums and government grants provided by the Austrian government, offset by a $46 thousanddecrease in product revenues, net. Collaboration revenues for the three months ended December 31, 2020include $1.8 millionfor 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 ended December 31, 2020, Nabriva recorded $47 thousandof product revenue, net of gross-to-net accruals.
- Research and development expenses decreased by
$2.4 millionfrom $5.2 millionfor the three months ended December 31, 2019to $2.8 millionfor the three months ended December 31, 2020. The decrease was primarily due to a $0.7 milliondecrease in staff costs, a $1.1 milliondecrease in research materials and purchased services, a $0.2 milliondecrease in stock-based compensation expense, a $0.1 milliondecrease in consulting fees, and a $0.3 milliondecrease in travel and other costs.
- Selling, general and administrative expense increased by
$0.4 millionfrom $17.1 millionfor the three months ended December 31, 2019to $17.5 millionfor the three months ended December 31, 2020. The increase was primarily due to a $5.3 millionincrease in commercial consultancy and a reserve for annual manufacturing purchase commitments, a $1.0 millionincrease in professional fees, a $0.3 millionincrease in insurance costs, and a $0.3 millionincrease in infrastructure expenses, partly offset by a $4.8 milliondecrease in staff costs due to the reduction of headcount, a $0.8 milliondecrease in stock-based compensation expense and a $0.8 milliondecrease in travel costs.
- Revenues decreased by
$4.5 millionfrom $9.5 millionfor the year ended December 30, 2019to $5.0 millionfor the year ended December 31, 2020, primarily due to a $3.5 milliondecrease in collaboration revenue and a $1.4 milliondecrease in product revenue, net, partially offset by a $0.4 millionincrease in research premiums and government grants provided by the Austrian government. The decrease in collaboration revenues was primarily due to the $5.0 millionrecognized in 2019 under the Sinovant license agreement, partially offset by $1.8 millionrecognized in 2020 under the SIVEXTRO distribution agreement with Merck & Co., Inc.
- Research and development expenses decreased by
$11.3 millionfrom $26.4 millionfor the year ended December 31, 2019to $15.1 millionfor the year ended December 31, 2020. The decrease was primarily due to a $7.2 milliondecrease in research materials and purchased services related to the development of lefamulin, a $2.9 milliondecrease in staff costs due to the reduction of employees, a $2.0 milliondecrease in research consulting fees, a $0.9 milliondecrease in stock-based compensation expense and $0.4 milliondecrease in travel expenses, partly offset by a $2.0 millionincrease in other fees due to a $2.6 millionNDA filing fee refund for CONTEPO in 2019.
- Selling, general and administrative expense decreased by
$7.2 millionfrom $62.5 millionfor the year ended December 31, 2019to $55.3 millionfor the year ended December 31, 2020. The decrease was primarily due to a $4.2 milliondecrease in staffing expense related to the termination of Nabriva´s sales force in early 2020, $3.7 milliondecrease in stock-based compensation expense, a $1.6 milliondecrease in travel expenses, a $0.7 milliondecrease in advisory and external consultancy expenses primarily related to commercialization activities and professional service fees, and a $0.1 milliondecrease in other corporate costs, partly offset by a $1.2 millionincrease in insurance costs and a $1.5 millionincrease 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 millionin cash and cash equivalents, compared to $86.0 millionas of December 31, 2019. In addition, Nabriva raised aggregate net proceeds of $23.4 millionfrom its March 2021financing and from sales under its at-the-market offering program after December 31, 2020. Based on its current operating plans, Nabriva expects that its existing cash resources, will be sufficient to enable it to fund its operating expenses, debt service obligations and capital expenditure requirements into the fourth quarter of 2021.
- Nabriva expects to begin selling its own brand of SIVEXTRO early in the second quarter of 2021. At that time, Nabriva will begin to report 100% of SIVEXTRO’s net sales in product revenue, net instead of reporting a percentage of Merck’s gross sales in collaboration revenue.
- Nabriva intends to commence a Phase 1 clinical trial to evaluate the pharmacokinetics, safety and tolerability of XENLETA in individuals with cystic fibrosis. Results from this trial are expected to inform further development of XENLETA as a treatment for staphylococcal lung infections in this population.
Please refer to our Annual Report on Forms 10-K for the fiscal year ended
Company to Host Conference Call
Nabriva’s management will host a conference call today at
About Nabriva Therapeutics plc
XENLETA (lefamulin) is a first-in-class semi-synthetic pleuromutilin antibiotic for systemic administration in humans discovered and developed by the
Any statements in this press release about future expectations, plans and prospects for
Nabriva Therapeutics plc
Consolidated Balance Sheets
|As of||As of|
|(in thousands, except share data)|
|Cash and cash equivalents||$||86,019||$||41,359|
|Accounts receivable, net and other receivables||2,744||3,909|
|Total current assets||91,170||57,218|
|Property, plant and equipment, net||2,474||768|
|Intangible assets, net||91||80|
|Liabilities and stockholders´ equity|
|Current portion of long-term debt||$||—||$||2,041|
|Accrued expense and other current liabilities||11,966||12,844|
|Total current liabilities||16,639||18,524|
|Other non-current liabilities||1,698||1,091|
|Total non-current liabilities||36,200||6,777|
|Ordinary shares, nominal value
|Preferred shares, par value
|Additional paid in capital||517,894||579,123|
|Accumulated other comprehensive income||27||27|
|Total stockholders’ equity||41,274||33,135|
|Total liabilities and stockholders’ equity||$||94,113||$||58,436|
Consolidated Statements of Operations
|Three Months Ended
|(in thousands, except share and per share data)||2019||2020||2019||2020|
|Product revenue, net||$||93||$||47||$||1,538||$||108|
|Research premium and grant revenue||81||425||1,733||2,163|
|Cost of product sales||(55||)||(365||)||(70||)||(766||)|
|Research and development expenses||(5,202||)||(2,841||)||(26,415||)||(15,102||)|
|Selling, general and administrative expenses||(17,146||)||(17,522||)||(62,485||)||(55,285||)|
|Total operating expenses||(22,403||)||(20,728||)||(88,970||)||(71,153||)|
|Loss from operations||(22,070||)||(18,268||)||(79,489||)||(66,126||)|
|Other income (expense):|
|Other income (expense), net||99||573||215||1,187|
|Loss on extinguishment of debt||—||—||—||(2,757||)|
|Loss before income taxes||(23,024||)||(17,893||)||(82,663||)||(69,345||)|
|Income tax benefit (expense)||(21||)||60||(101||)||(139||)|
|Loss per share|
|Basic and Diluted ($ 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
|Net cash provided by (used in):|
|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