Nabriva Therapeutics Reports 2018 Financial Results and Recent Corporate Highlights
- Two PDUFA dates in 2019:
- Company preparing for potential commercialization of two first-in-class antibiotics,
Lefamulin (IV and Oral) and CONTEPO (IV) in
“2018 was a year of tremendous progress for Nabriva. We acquired Zavante, submitted New Drug Applications (NDAs) for CONTEPO for the treatment of complicated-urinary tract infections (cUTIs), including acute pyelonephritis (AP), and for both intravenous and oral formulations of lefamulin for the treatment of community-acquired bacterial pneumonia (CABP),” said
RECENT CORPORATE AND DEVELOPMENT HIGHLIGHTS
RESEARCH AND DEVELOPMENT
- Submitted NDAs to the
FDAin the forth quarter of 2018 for:
° Intravenous (IV) CONTEPO for the treatment of cUTIs, including AP. CONTEPO has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by the
FDAfor the treatment of several serious infections, including cUTI, which enables Priority Review of the NDA. In January 2019, Nabriva Therapeuticsannounced that the FDAaccepted the NDA and granted a Priority Review for CONTEPO, with a Prescription Drug User Fee Act (PDUFA) action date for completion of the FDA’s review of April 30, 2019.
° Oral and IV formulations of lefamulin, a potentially first-in-class, pleuromutilin antibiotic, for the treatment of CABP. Both formulations of lefamulin were granted QIDP and Fast Track designation by the
FDA, enabling potential Priority Review of the NDAs by the FDA. In February 2019, Nabriva Therapeuticsannounced the FDAaccepted the NDAs and granted Priority Review for lefamulin with a PDUFA action date for completion of the FDA’s review of August 19, 2019.
- Announced positive topline results from the Lefamulin Evaluation Against Pneumonia (LEAP) 2 clinical trial, the second of two global, pivotal Phase 3 clinical trials evaluating the safety and efficacy of oral lefamulin for the treatment of CABP. In this trial, lefamulin met the
FDAand EMA primary endpoints and was shown to be generally well-tolerated.
- In January, 2019, hosted an Investor/Analyst Event featuring discussions with leading clinicians and researchers who addressed current and potential new treatments for CABP and cUTIs. Nabriva management also discussed the commercial strategy for the Company’s investigational antibiotics, lefamulin and CONTEPO. Presentations from the event can be found under the "Events and Presentations" tab http://investors.nabriva.com until
April 15, 2019.
- Business Development
° Completed the acquisition of
Zavante Therapeutics Inc.(“Zavante”) in July 2018for upfront consideration of approximately 8.2 million of Nabriva Therapeutics’ ordinary shares (which includes an indemnity holdback) to Zavante’s former stockholders.
° In addition, Zavante’s former stockholders are eligible to receive up to
$97.5 millionupon the achievement of specified regulatory and commercial milestones, which subject to specified limitations, may be settled in Nabriva Therapeutics’ ordinary shares.
- Bolstered our Management Team
° Appointed Ted Schroeder, former Chief Executive Officer of Zavante, as Chief Executive Officer of
Nabriva Therapeuticswho succeeded Dr. Colin Broom. Dr. Broom, remains on the Board of Directors of Nabriva Therapeutics.
° Appointed Jennifer Schranz, M.D., as Chief Medical Officer to lead clinical development and medical affairs.
° Named Dr.
Steven Gelone Presidentand Chief Operating Officer of Nabriva Therapeutics.
- Strengthened our Balance Sheet
° Closed up to a
$75.0 millionterm loan with Hercules Capital, Inc.in December 2018, $25.0 millionof which was funded on the day of closing with up to an additional $45.0 millionthat is available at Nabriva Therapeuticsoption, subject to the achievement of certain regulatory and commercial milestones.
° Completed a public offering of ordinary shares in
July 2018. The gross proceeds from the offering were $50.0 millionand net proceeds to the Company were $46.1 million, after deducting underwriting discounts and commissions and offering expenses.
March 2018, announced the initiation of a license agreement with Sinovant Sciences, an affiliate of Roivant Sciences, pursuant to which it granted Sinovant Sciences a license to develop and commercialize lefamulin in greater China.
$6.5million to date from Sinovant Sciences and will be eligible for up to approximately $90.0 million in additional milestone payments tied to the successful completion of certain regulatory and commercial milestones related to lefamulin for CABP, plus an additional $4.0 millionin milestone payments if lefamulin is approved for a second indication in China.
° In addition,
Nabriva Therapeuticswill be eligible to receive low double-digit royalties on sales upon approval in the covered territories. Sinovant Sciences is solely responsible for all clinical development and regulatory filings necessary to secure approval in the covered territories, as well as commercialization activities.
FULL YEAR 2018 FINANCIAL RESULTS
- For the year ended
December 31, 2018, Nabriva Therapeuticsreported a net loss of $114.8 million, or $2.26per share, which includes a $32.0 millionin-process research and development charge associated with the acquisition of Zavante, compared to a net loss of $74.4 million, or $2.49per share, for the year ended December 31, 2017.
- Research and development expenses increased by
$32.7 millionfrom $49.6 million for the year ended December 31, 2017to $82.3 million for the year ended December 31, 2018. The increase was primarily due to a $32.0 millionin-process research and development charge associated with the acquisition of Zavante, a $6.5 millionincrease in research consulting fees, a $6.5 millionincrease associated with the payment of the new drug application fees to the FDAand a $1.9 millionincrease in staff costs due to the addition of employees, partly offset by a $13.9 milliondecrease in research materials and purchased services related to the development of lefamulin.
- General and administrative expense increased by
$12.3 millionfrom $29.5 millionfor the year ended December 31, 2017to $41.7 million for the year ended December 31, 2018. The increase was primarily due to a $9.6 millionincrease in staff costs due to the addition of employees, a $2.6 millionincrease of advisory and external consultancy expenses primarily related to pre-commercialization activities and professional service fees and a $1.0 millionincrease in other corporate costs, partly offset by a $2.2 milliondecrease in legal fees.
- As of
December 31, 2018, Nabriva Therapeuticshad $102.2 millionin cash, cash equivalents and short-term investments compared to $86.9 millionas of December 31, 2017. Existing cash resources are expected to fund operations into the second quarter of 2020.
Please refer to the Annual Report on Form 10-K of
Any statements in this press release about future expectations, plans and prospects for
Sam Brown Inc.
Consolidated Balance Sheets
|(in thousands, except share data)||As of
|Cash and cash equivalents||$||86,769||$||102,003|
|Total current assets||93,839||108,753|
|Property, plant and equipment, net||1,327||1,139|
|Intangible assets, net||172||98|
|Liabilities and Stockholders’ equity|
|Accrued expense and other current liabilities||8,124||14,502|
|Total current liabilities||13,260||17,806|
|Other non-current liabilities||203||264|
|Total non-current liabilities||435||23,982|
|Ordinary shares, nominal value $0.01, 1,000,000,000 ordinary shares authorized at December 31, 2018; 36,707,685 and 67,019,094 issued and outstanding at December 31, 2017 and 2018, respectively||367||670|
|Preferred shares, par value $0.01, 100,000,000 shares authorized at December 31, 2018; None issued and outstanding||—||—|
|Additional paid in capital||360,872||461,911|
|Accumulated other comprehensive income||27||27|
|Total stockholders’ equity||82,068||68,630|
|Total liabilities and stockholders’ equity||$||95,763||$||110,418|
Consolidated Statements of Operations
|Year Ended December 31,|
|(in thousands, except share and per share data)||2017
|Research premium and grant revenue||5,319||3,156|
|Research and development||(49,615||)||(82,288||)|
|General and administrative||(29,472||)||(41,743||)|
|Total operating expenses||(79,087||)||(124,031||)|
|Loss from operations||(73,768||)
|Other income (expense):|
|Other income (expense), net||492||(272||)|
|Loss before income taxes||(73,001||)||(114,731||)|
|Income tax expense||(1,355||)||(49||)|
|Loss per share|
|Basic and diluted||$||(2.49||)
|Weighted average number of shares:|
|Basic and diluted||29,830,669||50,795,768|
Condensed Consolidated Statements of Cash Flows
|Net cash provided by (used in):|
|Effects of foreign currency translation on cash and cash equivalents||1,371||(362||)|
|Net increase in cash and cash equivalents||53,991||15,234|
|Cash and cash equivalents at beginning of year||32,778||86,769|
|Cash and cash equivalents at end of year||$||86,769||$||102,003|
Source: Nabriva Therapeutics US, Inc