Nabriva Therapeutics Reports Fourth Quarter and Year End 2019 Financial Results and Recent Corporate Highlights
-Prioritizing community opportunity for oral XENLETA given broad reimbursement coverage-
-Reducing balance sheet risk through early paydown of a substantial portion of Hercules loan-
-Pursuing options to provide lefamulin to patients with coronavirus with secondary bacterial infections-
-Conference call today at
“The approval and launch of XENLETA™ (lefamulin) for the treatment of community-acquired bacterial pneumonia (CABP) in
Our focus in 2020 will be guided by disciplined execution as we prioritize our marketing plans in parallel with thoughtful management of our corporate balance sheet and resources. In light of the strong positioning on managed care formularies, considerable breadth of coverage, and the high unmet medical need, we have made the strategic decision to shift the vast majority of our sales team’s efforts to the community. We have aligned our team’s efforts to the geographies with the greatest managed care coverage, and based on initial results, expect our targeted community outreach will drive new prescription growth and revenue. We remain committed to increasing awareness of XENLETA and preparing for the potential launch of CONTEPO in the hospital setting, recognizing that navigating the formulary review process takes time.”
RECENT CORPORATE AND DEVELOPMENT HIGHLIGHTS
- Nabriva resubmitted the New Drug Application (NDA) for CONTEPO to the
U.S. Food and Drug Administration(FDA) on December 20, 2019. CONTEPO or fosfomycin for injection is a novel, potentially first-in-class intravenous antibiotic in the U.S.for the treatment of complicated urinary tract infections. Nabriva received FDA acknowledgement of the NDA resubmission on January 8, 2020with a Prescription Drug User Fee Act (PDUFA) action date set for June 19, 2020.
December 20, 2019, Nabriva Therapeutics announced it had entered into a definitive agreement with certain institutional investors for the purchase and sale in a registered direct offering of (i) an aggregate of 13,793,106 ordinary shares and (ii) warrants to purchase up to an aggregate of 13,793,106 ordinary shares. Each ordinary share and accompanying warrant were sold together at a combined purchase price of $1.45. The warrants have an exercise price of $1.90per share, are initially exercisable six months following issuance (the “Initial Exercise Date”) and will expire on the 3-year anniversary of the Initial Exercise Date. The gross proceeds from the offering, before deducting the placement agent’s fees and other estimated offering expenses, were $20.1 million.
- The recent coronavirus outbreak is the most recent example of the impact infectious diseases have on public health. Similar to influenza virus infection, patients infected with the coronavirus are at increased risk for secondary bacterial pneumonia. Based on the information available from
China, up to 15% of COVID-19 infected patients have also developed secondary bacterial pneumonia. Given high mortality in the setting of concomitant viral and bacterial infection, timely and appropriate empiric antibacterial therapy should be considered and promptly administered to patients with suspected or documented bacterial superinfection in the setting of COVID-19, particularly in patients with risk factors for increased mortality such as older age, diabetes, and immunosuppressive conditions. Nabriva is working closely with the Biotechnology Innovation Organization(BIO), a biotechnology trade association, in organizing an industry response. Nabriva is also monitoring efforts by the U.S. Biomedical Advanced Research and Development Authority(BARDA) in its preparation for the potential need for widespread CABP treatment and has proactively submitted a brief via https://www.medicalcountermeasures.gov/ to make XENLETA available as a potential treatment option in patients infected with the coronavirus with suspected or documented secondary bacterial pneumonia. In addition, Nabriva is supporting Sinovant – its development and commercialization partner in greater Chinafor lefamulin – who is working closely with the National Medical Products Administrationin Chinato be prepared to offer lefamulin, should it be needed for the treatment of suspected or documented secondary bacterial pneumonia.
March 11, 2020, Nabriva entered into an amendment (the Amendment) to its Loan and Security Agreement (Loan Agreement) with Hercules Capital, Inc. (Hercules). Pursuant to the Amendment, Nabriva agreed to repay to Hercules between April 1, 2020and April 3, 2020, $30.0 millionof the $35.0 millionin aggregate principal amount of debt outstanding under the Loan Agreement (the Prepayment). Under the Amendment, Nabriva and Hercules agreed to defer the end of term loan charge payment in the amount of approximately $2.3 millionthat would have otherwise become payable on the date of the Prepayment and to reduce the charge with respect to the Prepayment from $600,000to $300,000and to defer its payment until June 1, 2023or such earlier date on which all loans under the Loan Agreement are repaid or become due and payable. The Amendment also reset the revenue performance covenant to 70% of targeted revenue based on a revised net product revenue forecast and lowered Nabriva’s minimum liquidity requirement to $3.0 millionin cash and cash equivalents (previously $40 million), in each case, following the Prepayment. The new minimum liquidity requirement will not apply if CONTEPO receives regulatory approval from the U.S. Food and Drug Administrationand Nabriva achieves at least 70% of its revised net product revenue targets under the Loan Agreement. Following the Prepayment, the Company may request to borrow an additional $5.0 millionsubject to Hercules’ sole discretion.
Three Months Ended
- For the three months ended
December 31, 2019, Nabriva Therapeutics recorded revenues of $0.3 million, a $0.5 million decrease compared to the three months ended December 31, 2018. The decrease was primarily a result of a $0.7 millionreduction in research premium and grant revenue, partly offset by $0.2 millionof collaboration revenue and $0.1 millionof net product revenues for the three months ended December 31, 2019. Nabriva reported a net loss of $23.0 million, or $0.29per share, for the three months ended December 31, 2019, compared to a net loss of $30.8 million, or $0.46per share, for the three months ended December 31, 2018.
- Research and development expenses decreased by
$16.3 million from $21.5 million for the three months ended December 31, 2018to $5.2 million for the three months ended December 31, 2019. The decrease was primarily due to a $6.5 millionpayment of new drug application fees to the FDA in the fourth quarter of 2018, $4.9 millionreduction in research study costs, $2.2 millionreduction in research consulting fees, $1.7 millionreduction in staff costs and $1.1 millionreduction in stock-based compensation costs.
- Selling, general and administrative expenses increased by
$6.9 million from $10.2 million for the three months ended December 31, 2018to $17.1 million for the three months ended December 31, 2019. The increase was primarily due to costs associated with the launch of XENLETA in 2019, $3.6 millionhigher personnel costs due to an increase in the number of employees in our sales force to support the launch of XENLETA, $1.9 millionhigher advisory and consulting costs and $1.2 millionhigher costs associated with stock-based compensation.
As previously disclosed, Nabriva’s initial sales of XENLETA in the third quarter of 2019 exceeded its expectations for product availability at its distributors. Nabriva’s distribution partners continue to primarily utilize their existing inventory to satisfy product demand which in turn impacted sales in the fourth quarter of 2019 and is expected to similarly impact sales during the first quarter of 2020.
- For the year ended
December 31, 2019, Nabriva Therapeutics recorded revenues of $9.5 million, a $0.2 milliondecrease compared to the year ended December 31, 2018. The decrease was primarily a result of a $1.4 millionreduction in research premiums and grant revenue and $0.3 millionreduction in collaboration revenue, partly offset by $1.5 millionof net product revenues for the year ended December 31, 2019. Nabriva reported a net loss of $82.8 million, or $1.12per share, for the year ended December 31, 2019compared to a net loss of $114.8 million, or $2.26per share, for the year ended December 31, 2018.
- Research and development expenses decreased by
$55.9 million from $82.3 million for the year ended December 31, 2018to $26.4 million for the year ended December 31, 2019. The decrease was primarily due to a $32.0 millionin-process research and development charge associated with the acquisition of Zavante in 2018, $10.6 millionreduction in research materials and purchased services for development of XENLETA due to wind down of activities, $8.1 millionreduction due to payment of the new drug application fees to the FDA in 2018, inclusive of a $2.6 millionNDA filing refund for CONTEPO, $4.6 millionreduction in research consulting fees and $1.2 millionreduction in staff costs, partly offset by $0.7 millionincrease in stock-based compensation costs for the year ended December 31, 2019.
- Selling, general and administrative expense increased by
$20.7 million from $41.7 million for the year ended December 31, 2018to $62.5 million for the year ended December 31, 2019. The increase was due to $8.6 millionincrease in staff costs mainly for our commercial sales force supporting XENLETA’s product launch in 2019, $5.9 millionincrease in advisory and external consultancy expenses related to pre-commercialization activities and professional service fees, $3.9 millionincrease in stock-based compensation costs and $2.4 millionincrease in other corporate costs for the year ended December 31, 2019.
- As of
December 31, 2019, Nabriva Therapeutics had $86.0 millionin cash and cash equivalents, compared to $102.0 millionas of December 31, 2018.
- Based on its current operating plans, immediately following the Prepayment, the Company expects that its existing cash resources and anticipated net product sales revenues, will be sufficient to enable Nabriva to fund its operating expenses, debt service obligations and capital expenditure requirements into the third quarter of 2020. This estimate assumes that Nabriva’s NDA for CONTEPO is approved on the PDUFA action date and that it remains in compliance with the covenants under its Loan Agreement.
Please refer to the Annual Report on Form 10-K of Nabriva Therapeutics for the fiscal year ended
Company to Host Conference Call
Nabriva’s management will host a conference call today at
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 Therapeutics received
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.
INDICATION AND IMPORTANT SAFETY INFORMATION
XENLETA is a pleuromutilin antibacterial indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of XENLETA and other antibacterial drugs, XENLETA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
IMPORTANT SAFETY INFORMATION
XENLETA is contraindicated in patients with known hypersensitivity to XENLETA or pleuromutilins.
XENLETA tablets are contraindicated for use with CYP3A4 substrates that prolong the QT interval.
WARNINGS AND PRECAUTIONS
XENLETA has the potential to prolong the QT interval. Avoid XENLETA in patients with known QT prolongation, ventricular arrhythmias, and patients receiving drugs that may prolong the QT interval.
Based on animal studies, XENLETA may cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception.
Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including XENLETA, with severity ranging from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs.
The most common adverse reactions (≥2%) for (a) XENLETA Injection are administration site reactions, hepatic enzyme elevation, nausea, hypokalemia, insomnia, and headache and (b) XENLETA Tablets are diarrhea, nausea, vomiting, and hepatic enzyme elevation.
USE IN SPECIFIC POPULATIONS
In patients with severe hepatic impairment, reduce the dosage of XENLETA Injection to 150 mg infused over 60 minutes every 24 hours. XENLETA Tablets are not recommended in patients with moderate or severe hepatic impairment due to insufficient information to provide dosing recommendations.
Avoid XENLETA Injection and Tablets with concomitant strong or moderate CYP3A or P-gp inducers. Monitor for reduced efficacy of XENLETA.
Avoid XENLETA Tablets with strong CYP3A or P-gp inhibitors.
Monitor for adverse reactions of sensitive CYP3A substrates administered with XENLETA Tablets.
XENLETA has not been studied in pregnant women. Verify pregnancy status in females prior to initiating XENLETA and advise females to use contraception during treatment and for 2 days after the final dose. Lactating women should pump and discard milk for the duration of treatment with XENLETA and for 2 days after the final dose.
To report SUSPECTED ADVERSE REACTIONS, or administration during pregnancy, contact
Please see Full Prescribing Information for XENLETA.
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 launch and commercialize XENLETA for the treatment of CABP, including the availability of and ease of access to XENLETA through major
Nabriva Therapeutics plc
Consolidated Balance Sheets
|(in thousands, except share data)||As of
|Cash and cash equivalents||$||102,003||$||86,019|
|Accounts receivable, net and other receivables||3,871||2,744|
|Total current assets||108,753||91,170|
|Property, plant and equipment, net||1,139||2,474|
|Intangible assets, net||98||91|
|Liabilities and equity|
|Accrued expense and other current liabilities||14,502||11,966|
|Total current liabilities||17,806||16,639|
|Other non-current liabilities||264||1,698|
|Total non-current liabilities||23,982||36,200|
|Ordinary shares, nominal value
|Preferred shares, par value
|Additional paid in capital||461,911||517,044|
|Accumulated other comprehensive income||27||27|
|Total stockholders’ equity||68,630||41,274|
|Total liabilities and stockholders’ equity||$||110,418||$||94,113|
Consolidated Statements of Operations
|Three Months Ended
|(in thousands, except share and per share data)||2018||2019||2018||2019|
|Product revenue, net||$||—||$||93||$||—||$||1,538|
|Research premium and grant revenue||797||81||3,156||1,733|
|Cost of product sales||—||(55||)||—||(70||)|
|Research and development expenses||(21,488||)||(5,202||)||(82,288||)||(26,415||)|
|Selling, general and administrative expenses||(10,188||)||(17,146||)||(41,743||)||(62,485||)|
|Total operating expenses (1)||(31,676||)||(22,403||)||(124,031||)||(88,970||)|
|Loss from operations||(30,879||)||(22,070||)||(114,375||)||(79,489||)|
|Other income (expense):|
|Other income (expense), net||(100||)||99||)||(272||)||215|
|Loss before income taxes||(31,083||)||(23,024||)||(114,731||)||(82,663||)|
|Income tax benefit (expense)||258||(21||)||(49||)||(101||)|
|Loss per share|
|Basic and Diluted ($ per share)||$||(0.46||)||$||(0.29||)||$||(2.26||)||$||(1.12||)|
|Weighted average number of shares:|
|Basic and Diluted||66,995,218||80,271,001||50,795,768||74,199,482|
(1) Total operating expenses include non-cash stock-based compensation expense of
| Condensed Consolidated Statements of Cash Flows
|Net cash provided by (used in):|
|Effects of foreign currency translation on cash and cash equivalents||(362||)||(106||)|
|Net increase/(decrease) in cash, cash equivalents and restricted cash||15,234||(15,592||)|
|Cash, cash equivalents and restricted cash at beginning of year||86,769||102,003|
|Cash, cash equivalents and restricted cash at end of year||$||102,003||$||86,411|
Source: Nabriva Therapeutics US, Inc