Nabriva Therapeutics plc

2023 Q3 Form 10-Q Financial Statement

#000155837023016524 Filed on October 19, 2023

View on sec.gov

Income Statement

Concept 2023 Q3 2023 Q2

Balance Sheet

Concept 2023 Q3 2023 Q2
SHORT-TERM ASSETS
Cash & Short-Term Investments $2.200M
YoY Change -89.02%
Cash & Equivalents $2.182M
Short-Term Investments
Other Short-Term Assets $3.400M
YoY Change -46.53%
Inventory $0.00
Prepaid Expenses $3.258M
Receivables $4.400M
Other Receivables $0.00
Total Short-Term Assets $9.952M
YoY Change -81.67%
LONG-TERM ASSETS
Property, Plant & Equipment $246.0K
YoY Change 19.42%
Goodwill
YoY Change
Intangibles $1.000K
YoY Change -92.31%
Long-Term Investments
YoY Change
Other Assets $379.0K
YoY Change 0.26%
Total Long-Term Assets $626.0K
YoY Change 4.86%
TOTAL ASSETS
Total Short-Term Assets $9.952M
Total Long-Term Assets $626.0K
Total Assets $10.58M
YoY Change -80.73%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $14.03M
YoY Change 1207.18%
Accrued Expenses $11.98M
YoY Change 2.97%
Deferred Revenue
YoY Change
Short-Term Debt $0.00
YoY Change
Long-Term Debt Due $196.0K
YoY Change -97.04%
Total Short-Term Liabilities $26.20M
YoY Change 35.54%
LONG-TERM LIABILITIES
Long-Term Debt $344.0K
YoY Change -32.81%
Other Long-Term Liabilities $352.0K
YoY Change -20.72%
Total Long-Term Liabilities $696.0K
YoY Change -27.2%
TOTAL LIABILITIES
Total Short-Term Liabilities $26.20M
Total Long-Term Liabilities $696.0K
Total Liabilities $26.90M
YoY Change 32.59%
SHAREHOLDERS EQUITY
Retained Earnings -$673.6M
YoY Change 8.9%
Common Stock $657.3M
YoY Change 0.63%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity -$16.32M
YoY Change
Total Liabilities & Shareholders Equity $10.58M
YoY Change -80.73%

Cashflow Statement

Concept 2023 Q3 2023 Q2

Facts In Submission

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us-gaap Nature Of Operations
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<p style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-weight:bold;margin:0pt 0pt 12pt 0pt;">1.           Organization and Business Activities</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:0pt;">Nabriva Therapeutics plc, or Nabriva Ireland, together with its wholly owned and consolidated subsidiaries, Nabriva Therapeutics GmbH, or Nabriva Austria, Nabriva Therapeutics US, Inc., Zavante Therapeutics, Inc., or Zavante, and Nabriva Therapeutics Ireland DAC, collectively, Nabriva, or the Company, is a biopharmaceutical company that historically engaged in the commercialization and research and development of novel anti-infective agents to treat serious infections. The Company has the commercial rights to an approved product, XENLETA, as well as a development product candidate, CONTEPO. The Company’s headquarters are located at Alexandra House, Office 225/227, The Sweepstakes, Dublin 4, Ireland.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:0pt;"><span style="visibility:hidden;">​</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:0pt;">As part of a plan approved by its board of directors on January 4, 2023 to preserve its cash to adequately fund an orderly wind down of its operations, or the Cash Preservation Plan, the Company previously reduced its operations to those necessary to: (i) make SIVEXTRO and XENLETA commercially available to wholesale customers; (ii) identify and explore strategic options, including the sale, license or other disposition of one or more of its assets, technologies or products; and (iii) wind down its business. The Company has no intention of resuming any active sales promotion or research and development activities. As part of the Cash Preservation Plan, the Company terminated all of its employees<span style="white-space:pre-wrap;">. </span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:0pt;"><span style="visibility:hidden;">​</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:0pt;">The total cost of severance associated with the wind down of our operations is approximately $5.4 million, of which $1.3 million was recorded in research and development expenses and $4.1 million was recorded in selling, general and administrative expenses in the statement of operations for the six months ended June 30, 2023. As of June 30, 2023, the remaining unpaid balance of severance costs is $2.7 million, which is recorded in accrued expenses and other current liabilities in the consolidated balance sheet and which is expected to be paid prior to the end of 2023.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:0pt;"><span style="visibility:hidden;">​</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:0pt;"><span style="white-space:pre-wrap;">In January 2023, the Company settled all outstanding balances due to Hercules Capital, Inc., or Hercules, and removed all secured liens on all of its assets. The Company also terminated its agreement with Amplity Health, the contract sales organization responsible for promoting SIVEXTRO and XENLETA and, on January 31, 2023, entered into a letter agreement, or the Letter Agreement, relating to the Company’s Sales Promotion and Distribution Agreement, or the Distribution Agreement, with MSD International GmbH, or MSD, and Merck Sharp &amp; Dohme Corp., or the Supplier, to begin transition responsibility for the promotion and distribution of SIVEXTRO back to Merck &amp; Co. Inc., or Merck. The Company stopped selling SIVEXTRO</span><span style="white-space:pre-wrap;"> when its Distribution Agreement with Merck expired on June 30, 2023. </span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:0pt;"><span style="visibility:hidden;">​</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:0pt;"><span style="white-space:pre-wrap;">On July 30, 2023, the Company entered into an Asset Purchase Agreement with Sumitomo Pharma Co., Ltd., or Sumitomo, pursuant to which Sumitomo agreed to (i) purchase, among other things, the Company’s assets and rights related to the development, manufacture, marketing and commercialization of XENLETA in the People’s Republic of China, Hong Kong, Macau and Taiwan, or collectively the Territory, and (ii) assume certain liabilities related to the acquired assets. The transactions contemplated by the Asset Purchase Agreement closed on July 30, 2023. At the closing, Sumitomo made an upfront cash payment of </span>$15.0 million, of which (i) $1.8 million was held back as security for potential indemnification claims, (ii) $10.4 million was paid by Sumitomo, on behalf of the Company, to certain of the Company’s contract manufacturing organizations to settle and discharge the remaining obligations under such agreements and (iii) $2.8<span style="white-space:pre-wrap;"> million was paid to the Company in cash. The cash received by the Company is not reflected on the balance sheet at June 30, 2023. </span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:0pt;"><span style="visibility:hidden;">​</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:0pt;">As part of the transactions contemplated by the Asset Purchase Agreement, the Company terminated <span style="background:#ffffff;">its license agreement and certain related agreements with certain affiliates of Sumitomo, including Sumitomo Pharmaceuticals (Suzhou), pursuant to which the Company previously had granted an exclusive license to develop and commercialize, and a non-exclusive license to manufacture, certain products containing lefamulin in the Territory.</span><span style="white-space:pre-wrap;"> During a period of time that may extend to March 31, 2024, the Company has agreed to provide certain post-closing services to Sumitomo, including to continue and maintain the application for marketing approval for XENLETA filed by Nabriva Ireland with the National Medical Products Administration, or NMPA, of the People’s Republic of China, the import drug license for </span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="white-space:pre-wrap;">lefamulin filed with the NMPA and the existing market approval for lefamulin in the United States. In exchange for these obligations, Sumitomo has agreed to fully reimburse the Company for expenses incurred with respect to the post-closing activities. </span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">​</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:0pt;">Following the closing of the transactions with Sumitomo, the Company is currently focused on the sale of its remaining assets, including CONTEPO. </p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">​</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-style:italic;margin:0pt 0pt 12pt 0pt;">Liquidity</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:0pt;">Since adopting the Cash Preservation Plan in January 2023, the Company has significantly reduced its expenses. As of June 30, 2023, the Company had cash, cash equivalents and restricted cash of $2.3 million.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:0pt;"><span style="font-style:italic;visibility:hidden;">​</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:0pt 0pt 12pt 0pt;">The Company follows the provisions of Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or ASC, Topic 205-40<i style="font-style:italic;">,</i> <i style="font-style:italic;">Presentation of Financial Statements- Going Concern,</i><span style="white-space:pre-wrap;"> which requires management to assess the Company’s ability to continue as a going concern for one year after the date the consolidated financial statements are issued. As a result, the Company’s liquidity condition and its existing financial obligations raise substantial doubt about the Company’s ability to continue as a going concern one year from the date that these financial statements are filed. The consolidated financial statements have been prepared assuming the Company will continue as a going concern, which contemplates the continuity of operations, the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. Management has concluded that substantial doubt exists about the Company’s ability to continue as a going concern for one year from the date these consolidated financial statements are issued. The financial statements do not include any adjustments relating to the recovery of the recorded assets or the classification of the liabilities that might be necessary should the Company be unable to continue as a going concern.</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:0pt;">The Company previously had sources of liquidity under an “at-the-market” equity financing facility with Jefferies LLC and an equity line of credit facility with Lincoln Park Capital Fund, LLC. The Company has not raised any proceeds under such facilities during 2023 and has no plans to raise any proceeds prior to the wind down of its business.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="font-size:12pt;visibility:hidden;">​</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:36pt;margin:0pt 0pt 12pt 0pt;">Based on its current operating plans, the Company expects that its existing cash, cash equivalents and restricted cash as of the filing date of this Quarterly Report on Form 10-Q will be sufficient to enable the Company to fund its operating expenses and debt service obligations through the end of October 2023. The Company has based this estimate on assumptions that may prove to be wrong, and the Company could use its capital resources sooner than expected. This estimate assumes, among other things, that the Company does not obtain any additional funding from the sale of its assets. <span style="white-space:pre-wrap;"> </span></p>
us-gaap Restructuring Costs
RestructuringCosts
5400000
CY2023Q2 us-gaap Restructuring Costs
RestructuringCosts
5400000
CY2023Q2 us-gaap Restructuring Reserve Current
RestructuringReserveCurrent
2700000
CY2023Q2 us-gaap Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalents
2300000
CY2022Q3 nbrv Shares Issued During Period Fractional Shares
SharesIssuedDuringPeriodFractionalShares
0
CY2022Q4 us-gaap Inventory Net
InventoryNet
9676000
CY2023Q2 us-gaap Long Term Debt Current
LongTermDebtCurrent
196000
CY2022Q4 us-gaap Long Term Debt Current
LongTermDebtCurrent
4833000
CY2023Q2 nbrv Research And Development Related Liabilities Current
ResearchAndDevelopmentRelatedLiabilitiesCurrent
247000
CY2022Q4 nbrv Research And Development Related Liabilities Current
ResearchAndDevelopmentRelatedLiabilitiesCurrent
707000
CY2023Q2 us-gaap Employee Related Liabilities Current
EmployeeRelatedLiabilitiesCurrent
3042000
CY2022Q4 us-gaap Employee Related Liabilities Current
EmployeeRelatedLiabilitiesCurrent
1737000
CY2023Q2 us-gaap Accrued Professional Fees Current
AccruedProfessionalFeesCurrent
281000
CY2022Q4 us-gaap Accrued Professional Fees Current
AccruedProfessionalFeesCurrent
552000
CY2023Q2 nbrv Manufacturing And Inventory Related Expenses Current
ManufacturingAndInventoryRelatedExpensesCurrent
2566000
CY2022Q4 nbrv Manufacturing And Inventory Related Expenses Current
ManufacturingAndInventoryRelatedExpensesCurrent
8113000
CY2023Q2 nbrv Reserve For Product Returns
ReserveForProductReturns
568000
CY2022Q4 nbrv Reserve For Product Returns
ReserveForProductReturns
784000
CY2023Q2 nbrv Accrual For Government Rebates
AccrualForGovernmentRebates
2102000
CY2022Q4 nbrv Accrual For Government Rebates
AccrualForGovernmentRebates
2028000
CY2023Q2 nbrv Accrued Liabilities Gross To Net
AccruedLiabilitiesGrossToNet
2231000
CY2022Q4 nbrv Accrued Liabilities Gross To Net
AccruedLiabilitiesGrossToNet
2129000
CY2023Q2 us-gaap Other Accrued Liabilities Current
OtherAccruedLiabilitiesCurrent
944000
CY2022Q4 us-gaap Other Accrued Liabilities Current
OtherAccruedLiabilitiesCurrent
1291000
CY2023Q2 us-gaap Accrued Liabilities Current
AccruedLiabilitiesCurrent
11981000
CY2022Q4 us-gaap Accrued Liabilities Current
AccruedLiabilitiesCurrent
17341000
CY2023Q2 us-gaap Long Term Debt Noncurrent
LongTermDebtNoncurrent
344000
CY2022Q4 us-gaap Long Term Debt Noncurrent
LongTermDebtNoncurrent
388000
CY2023Q2 us-gaap Long Term Debt Maturities Repayments Of Principal Remainder Of Fiscal Year
LongTermDebtMaturitiesRepaymentsOfPrincipalRemainderOfFiscalYear
148000
CY2023Q2 us-gaap Long Term Debt Maturities Repayments Of Principal In Next Twelve Months
LongTermDebtMaturitiesRepaymentsOfPrincipalInNextTwelveMonths
196000
CY2023Q2 us-gaap Long Term Debt Maturities Repayments Of Principal In Year Two
LongTermDebtMaturitiesRepaymentsOfPrincipalInYearTwo
196000
CY2023Q2 us-gaap Revenue From Contract With Customer Excluding Assessed Tax
RevenueFromContractWithCustomerExcludingAssessedTax
2243000
CY2022Q2 us-gaap Revenue From Contract With Customer Excluding Assessed Tax
RevenueFromContractWithCustomerExcludingAssessedTax
9191000
us-gaap Revenue From Contract With Customer Excluding Assessed Tax
RevenueFromContractWithCustomerExcludingAssessedTax
9833000
us-gaap Revenue From Contract With Customer Excluding Assessed Tax
RevenueFromContractWithCustomerExcludingAssessedTax
17211000
CY2023Q2 us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
98000
CY2022Q2 us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
334000
us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
1097000
us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
1334000
CY2023Q2 us-gaap Income Tax Expense Benefit
IncomeTaxExpenseBenefit
0
CY2022Q2 us-gaap Income Tax Expense Benefit
IncomeTaxExpenseBenefit
400000
us-gaap Income Tax Expense Benefit
IncomeTaxExpenseBenefit
700000
CY2023Q2 us-gaap Net Income Loss
NetIncomeLoss
-12062000
CY2022Q2 us-gaap Net Income Loss
NetIncomeLoss
-11074000
us-gaap Net Income Loss
NetIncomeLoss
-20762000
us-gaap Net Income Loss
NetIncomeLoss
-22893000
CY2023Q2 us-gaap Weighted Average Number Of Shares Outstanding Basic
WeightedAverageNumberOfSharesOutstandingBasic
3230827
CY2022Q2 us-gaap Weighted Average Number Of Shares Outstanding Basic
WeightedAverageNumberOfSharesOutstandingBasic
2529523
us-gaap Weighted Average Number Of Shares Outstanding Basic
WeightedAverageNumberOfSharesOutstandingBasic
3227629
us-gaap Weighted Average Number Of Shares Outstanding Basic
WeightedAverageNumberOfSharesOutstandingBasic
2441136
CY2023Q2 us-gaap Earnings Per Share Basic
EarningsPerShareBasic
-3.73
CY2022Q2 us-gaap Earnings Per Share Basic
EarningsPerShareBasic
-4.38
us-gaap Earnings Per Share Basic
EarningsPerShareBasic
-6.43
us-gaap Earnings Per Share Basic
EarningsPerShareBasic
-9.38
CY2022Q3 nbrv Number Of Countries Exclusive Rights Are Distributed
NumberOfCountriesExclusiveRightsAreDistributed
9
CY2022Q3 nbrv Number Of Additional Countries Rights Are Distributed Through Named Patient Usage Program
NumberOfAdditionalCountriesRightsAreDistributedThroughNamedPatientUsageProgram
5
us-gaap Loss Contingency Loss In Period
LossContingencyLossInPeriod
400000

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