0001558370-23-010302 | 10-Q | XBRL Viewer

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Inventory (Details) - USD ($) $ in Thousands	Mar. 31, 2023	Dec. 31, 2022
Inventory
Total inventory	$ 9,027	$ 9,676
XENLETA
Inventory
Raw materials	916	916
Work in process	6,003	4,658
Finished goods	632	640
Total inventory	7,551	6,214
Obsolete inventory non-cash reserve		5,600
SIVEXTRO
Inventory
Finished goods	$ 1,476	$ 3,462

Consolidated Statements of Changes in Stockholders' Equity (Deficit) - USD ($) $ in Thousands	Ordinary shares	Additional paid in capital	Accumulated other comprehensive income	Accumulated deficit	Total
Stockholders' equity, beginning balance at Dec. 31, 2021	$ 23	$ 648,976	$ 27	$ (595,676)	$ 53,350
Stockholders' equity, beginning balance (in shares) at Dec. 31, 2021	2,269
Consolidated Statements of Changes in Stockholders' Equity (Deficit)
Issuance of ordinary shares	$ 2	2,219			2,221
Issuance of ordinary shares (in shares)	198
Shares issued in connection with the vesting of restricted stock units (in shares)	3
Equity transaction costs		(127)			(127)
Stock-based compensation expense		1,000			1,000
Net loss				(11,819)	(11,819)
Stockholders' equity, ending balance at Mar. 31, 2022	$ 25	652,068	27	(607,495)	44,625
Stockholders' equity, ending balance (in shares) at Mar. 31, 2022	2,470
Stockholders' equity, beginning balance at Dec. 31, 2022	$ 32	656,095	27	(652,861)	3,293
Stockholders' equity, beginning balance (in shares) at Dec. 31, 2022	3,201
Consolidated Statements of Changes in Stockholders' Equity (Deficit)
Equity transaction costs		1			1
Stock-based compensation expense		1,049			1,049
Net loss				(8,700)	(8,700)
Stockholders' equity, ending balance at Mar. 31, 2023	$ 32	$ 657,145	$ 27	$ (661,561)	$ (4,357)
Stockholders' equity, ending balance (in shares) at Mar. 31, 2023	3,201

Significant Arrangements and License Agreements (Details) $ in Thousands			1 Months Ended		3 Months Ended						12 Months Ended
	Apr. 12, 2021	Jul. 10, 2020 USD ($)	Dec. 31, 2020 USD ($)	Mar. 31, 2019 USD ($)	Mar. 31, 2023 USD ($)	Mar. 31, 2022 USD ($)	Mar. 31, 2021 USD ($)	Dec. 31, 2020 USD ($)	Sep. 30, 2019 USD ($)	Mar. 31, 2019 USD ($)	Dec. 31, 2021 USD ($)	Jul. 13, 2022 country	May 31, 2021 USD ($)
License Agreement
Number of countries, exclusive rights are distributed. \| country												9
Number of additional countries rights are distributed \| country												5
Revenue accounted for under Topic 606					$ 7,590	$ 8,020
SIVEXTRO
License Agreement
Percentage of net product sales recognized	100.00%
Sunovion Pharmaceutics Canada, Inc. \| Collaboration revenue - Upfront payment
License Agreement
Revenue accounted for under Topic 606				$ 1,000
Sumitomo Pharmaceuticals (Suzhou) \| Collaboration revenue - Upfront payment \| Approval of XENLETA
License Agreement
Revenue accounted for under Topic 606			$ 5,000
Additional revenue recognized					$ 3,000
License Agreement \| Sunovion Pharmaceutics Canada, Inc. \| NDS Approval
License Agreement
Revenue accounted for under Topic 606		$ 500
License Agreement \| Sumitomo Pharmaceuticals (Suzhou)
License Agreement
Upfront payment													$ 5,000
Notice period for termination of agreement					180 days
License Agreement \| Sumitomo Pharmaceuticals (Suzhou) \| Achievement of certain regulatory and commercial milestones
License Agreement
Maximum contingent milestone payment													91,500
License Agreement \| Sumitomo Pharmaceuticals (Suzhou) \| Subsequent regulatory approval
License Agreement
Maximum contingent milestone payment													$ 4,000
License Agreement \| Sumitomo Pharmaceuticals (Suzhou) \| Clinical trial application submission
License Agreement
Proceeds from license agreement, milestone										$ 1,500
License Agreement \| Sumitomo Pharmaceuticals (Suzhou) \| FDA approval
License Agreement
Revenue accounted for under Topic 606									$ 5,000
License Agreement \| Sumitomo Pharmaceuticals (Suzhou) \| Approval of XENLETA
License Agreement
Remaining probable of achieving											$ 1,000
License Agreement \| Sumitomo Pharmaceuticals (Suzhou) \| Additional regulatory approvals and annual sales targets
License Agreement
Remaining milestone payments					$ 86,000
License Agreement \| Sumitomo Pharmaceuticals (Suzhou) \| Collaboration revenue - Upfront payment
License Agreement
Revenue accounted for under Topic 606			$ 3,000					$ 1,000		$ 5,000
Milestone achieved							$ 1,000

Debt (Tables)

3 Months Ended

Mar. 31, 2023

Debt

Schedule of long-term debt


		As of		As of
		March 31,		December 31,
(in thousands)		2023		2022
Term loan payable	$	—	$	2,079
End of term fee		—		2,615
Unamortized debt issuance costs		—		(55)
Carrying value of term loan		—		4,639
Other debt		542		582
Less: Amounts due within one year		(197)		(4,833)
Total long-term debt	$	345	$	388

Schedule of maturities of long-term debt


(in thousands)
2023	$	148
2024	$	197
2025	$	197

- Definition

Tabular disclosure of long-debt instruments or arrangements, including identification, terms, features, collateral requirements and other information necessary to a fair presentation. These are debt arrangements that originally required repayment more than twelve months after issuance or greater than the normal operating cycle of the entity, if longer.

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+ Details

Revenues (Tables)

3 Months Ended

Mar. 31, 2023

Revenues

Summary of revenue by type


	Three Months Ended
	March 31,
(in thousands)	2023		2022
Product revenue, net	$	7,561	$	7,040
Collaboration revenues		29		629
Research premium and grant revenue		—		351
Total revenues	$	7,590	$	8,020

Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands	Mar. 31, 2023	Dec. 31, 2022
Accrued expenses and other liabilities
Research and development related costs	$ 363	$ 707
Payroll and related costs	5,123	1,737
Accounting, tax and audit services	568	552
Manufacturing and inventory	8,628	8,113
Product returns	774	784
Government rebates	2,234	2,028
Other accrued gross to net	2,194	2,129
Other	939	1,291
Total accrued expenses and other current liabilities	20,823	$ 17,341
Other contractual commitments	$ 6,064

Revenues - Summary of Gross-To-Net ("GTN") Adjustments (Details) - USD ($) $ in Millions	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
SIVEXTRO
Disaggregation of Revenue [Line Items]
GTN accrual adjustments	$ 7.6	$ 7.0

Revenues (Details) - USD ($) $ in Thousands	3 Months Ended
Revenues (Details) - USD ($) $ in Thousands	Mar. 31, 2023	Mar. 31, 2022
Revenue
Revenue accounted for under Topic 606	$ 7,590	$ 8,020
Product revenue, net
Revenue
Revenue accounted for under Topic 606	7,561	7,040
Collaboration revenue
Revenue
Revenue accounted for under Topic 606	29	629
Collaboration revenue \| Sumitomo Pharmaceuticals (Suzhou) \| License Agreement
Revenue
Revenue accounted for under Topic 606	$ 100	600
Research premium and grant revenue
Revenue
Revenue accounted for under Topic 606		$ 351

- Definition

Amount, excluding tax collected from customer, of revenue from satisfaction of performance obligation by transferring promised good or service to customer. Tax collected from customer is tax assessed by governmental authority that is both imposed on and concurrent with specific revenue-producing transaction, including, but not limited to, sales, use, value added and excise.

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+ Details

Commitments and Contingencies (Tables)

3 Months Ended

Mar. 31, 2023

Commitments and Contingencies

Schedule of future minimum contractual obligations and commitments


	Year Ending December 31,
(in thousands)	Total		Remainder of 2023		2024		2025		2026		2027		Thereafter
Operating lease obligations	$	498		498		—		—		—		—	$	—
XENLETA API purchase		39,746		3,368		3,368		4,776		4,776		4,776		18,682
Other contractual commitments		6,064		3,790		1,385		889		—		—		—
Total contractual commitments and contingencies	$	46,308	$	7,656	$	4,753	$	5,665	$	4,776	$	4,776	$	18,682

Commitments and Contingencies (Details) € in Millions, $ in Millions		3 Months Ended
	Aug. 04, 2021 EUR (€)	Mar. 31, 2023	Jul. 31, 2018 USD ($)
Zavante Therapeutics
Acquisition of Zavante
Milestone payment receivable prior acquisition			$ 3.0
Threshold milestone payment that may be settled in ordinary shares			26.0
Zavante Therapeutics \| Maximum
Acquisition of Zavante
Contingent consideration			97.5
Hovione Supply Agreement
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
Cash payments made for amendment of agreement \| €	€ 3.2
Threshold aggregate royalty payments \| €	4.0
Acquisition of Zavante
Percentage of annual minimum purchase requirement reduction in 2021		0.00%
Percentage of annual minimum purchase requirement reduction 2022 to 2024		50.00%
Percentage of annual minimum purchase requirement reduction in 2025		25.00%
Hovione Supply Agreement \| Maximum
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items]
Royalty payment \| €	€ 10.0
Approval Milestone Payment \| Zavante Therapeutics
Acquisition of Zavante
Contingent consideration			25.0
Net Sales Milestone Payments \| Zavante Therapeutics
Acquisition of Zavante
Contingent consideration			$ 72.5

Inventory - Prepaid Inventory (Details) $ in Millions	Dec. 31, 2022 USD ($)
Prepaid expense
Inventory [Line Items]
Prepaid inventory	$ 0.9

Earnings (Loss) per Share - Basic and Diluted (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Basic and Diluted Loss per Share
Net loss for the period	$ (8,700)	$ (11,819)
Weighted average number of shares outstanding, Basic	3,201,495	2,351,766
Weighted average number of shares outstanding, Diluted	3,201,495	2,351,766
Basic loss ($ per share)	$ (2.72)	$ (5.03)
Diluted loss ($ per share)	$ (2.72)	$ (5.03)

- Definition

The amount of net income (loss) for the period per each share of common stock or unit outstanding during the reporting period.

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- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

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+ Details

Share-Based Payments - Restricted Stock Units (Details) - Restricted Share Units ("RSUs") $ / shares in Units, $ in Millions	3 Months Ended
	Mar. 31, 2023 USD ($) $ / shares shares
Restricted Stock Units
Number of shares outstanding \| shares	38,635
Vested and issued \| shares	(63)
Forfeited \| shares	(1,314)
Number of shares outstanding \| shares	37,258
Weighted average grant date fair value per share
Weighted average grant date fair value per share at the beginning \| $ / shares	$ 41.89
Vested and issued \| $ / shares	383.33
Forfeited \| $ / shares	92.34
Weighted average grant date fair value per share at the end \| $ / shares	$ 39.54
Additional disclosures
Total unrecognized compensation related to unvested RSUs \| $	$ 0.1
Recognition period	2 years 4 months 24 days

Summary of Significant Accounting Policies (Policies)	3 Months Ended
Summary of Significant Accounting Policies (Policies)	Mar. 31, 2023
Summary of Significant Accounting Policies
Basis of Preparation	Basis of Preparation The unaudited consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America, or US GAAP, for interim financial information, and US Securities and Exchange Commission, or SEC, regulations for quarterly reporting. The unaudited consolidated financial statements include the accounts of Nabriva Therapeutics plc and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. The accompanying consolidated financial information as of March 31, 2023 and for the three months ended March 31, 2023 and 2022 are unaudited. The December 31, 2022 balance sheet was derived from audited consolidated financial statements but does not include all disclosures required by US GAAP. The interim unaudited consolidated financial statements have been prepared on the same basis as the annual audited consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of March 31, 2023 and results of operations for the three months ended March 31, 2023 and 2022. The financial data and other information disclosed in these notes related to the three ended March 31, 2023 and 2022 are not necessarily indicative of the results to be expected for the year ending December 31, 2023, any other interim periods or any future year or period. These unaudited consolidated financial statements should be read in conjunction with the audited consolidated financial statements and the notes thereto for the year ended December 31, 2022 contained in the Company’s Annual Report on Form 10-K, as filed with the SEC on April 17, 2023. The Company’s significant accounting policies are described in Note 2 of the notes to the consolidated financial statements included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, as filed with the SEC on April 17, 2023. Since the date of those financial statements, there have been no changes to the Company’s significant accounting policies.
Fair Value Measurement	Fair Value Measurement As of March 31, 2023, and December 31, 2021, the Company did not hold any financial instruments as liabilities that were held at fair value. The Company believes that the carrying value of its long-term debt approximates fair value based on current interest rates. Receivables and accounts payable are carried at their historical cost which approximates fair value due to their short-term nature.
Reverse Stock Split	Reverse Stock Split On September 16, 2022, the Company filed an Amended and Restated Memorandum and Articles of Association of the Company with the Irish Companies Registration Office and effected, a one-for-twenty five reverse stock split, or the Reverse Stock Split, of the Company’s ordinary shares. As a result of the Reverse Stock Split, every twenty five ordinary shares in the authorized and unissued and authorized and issued share capital of the Company were consolidated into one ordinary share. No fractional shares were issued in connection with the Reverse Stock Split. Shareholders who would otherwise be entitled to a fractional ordinary share were instead entitled to receive a proportional cash payment. All ordinary share, per share and related information presented in the consolidated financial statements and notes has been retroactively adjusted to reflect the Reverse Stock Split.
Recently Adopted Accounting Pronouncements	Recently Adopted Accounting Pronouncements In June 2016, the Financial Accounting Standards Board issued Accounting Standards Update (ASU) No. 2016-13, Financial Instruments-Credit Losses: Measurement of Credit Losses on Financial Instruments, or ASU 2016-13, which replaces the incurred loss impairment methodology under current U.S. GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. ASU 2016-13 was subsequently updated by ASU No. 2019-04, Codification Improvements to Topic 326, Financial Instruments—Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments, to clarify that entities should include recoveries when estimating the allowance for credit losses. This guidance was effective for the Company starting in fiscal year 2023. The Company adopted ASU 2016-13 as of January 1, 2023, which did not have a material impact on its financial statements.

Consolidated Balance Sheets - USD ($) $ in Thousands	Mar. 31, 2023	Dec. 31, 2022
Current assets:
Cash and cash equivalents	$ 1,798	$ 12,414
Restricted cash	123	123
Accounts receivable, net and other receivables	10,510	6,742
Inventory	9,027	9,676
Prepaid expenses	2,236	2,149
Total current assets	23,694	31,104
Property and equipment, net	263	280
Intangible assets, net	2	3
Other non-current assets	379	378
Total assets	24,338	31,765
Current liabilities:
Current portion of long-term debt	197	4,833
Accounts payable	6,978	5,431
Accrued expense and other current liabilities	20,823	17,341
Total current liabilities	27,998	27,605
Non-current liabilities:
Long-term debt	345	388
Other non-current liabilities	352	479
Total non-current liabilities	697	867
Total liabilities	28,695	28,472
Commitments and contingencies (Note 11)
Stockholders' equity (deficit):
Ordinary shares, nominal value $0.01, 12,000,000 ordinary shares authorized at March 31, 2023; 3,201,495 and 3,201,417 issued and outstanding at March 31, 2023 and December 31, 2022, respectively	32	32
Preferred shares, nominal value $0.01, 100,000,000 shares authorized at March 31, 2023; None issued and outstanding
Additional paid in capital	657,145	656,095
Accumulated other comprehensive income	27	27
Accumulated deficit	(661,561)	(652,861)
Total stockholders' equity (deficit)	(4,357)	3,293
Total liabilities and stockholders' equity (deficit)	$ 24,338	$ 31,765

Summary of Significant Accounting Policies - Reverse Stock Split (Details)	Sep. 16, 2022 shares
Summary of Significant Accounting Policies
Conversion ratio of common stock to ordinary shares	0.04%
Fractional shares	0

Consolidated Statements of Cash Flows - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Cash flows from operating activities
Net loss	$ (8,700)	$ (11,819)
Adjustments to reconcile net loss to net cash used in operating activities:
Non-cash other income, net	(2)	164
Non-cash interest income		(1)
Non-cash interest expense	55	93
Depreciation and amortization expense	21	78
Stock-based compensation	999	1,000
Other	314	10
Changes in operating assets and liabilities:
(Increase) decrease in other non-current assets	(1)	1
(Increase) decrease in accounts receivable, net and other receivables and prepaid expenses	(3,855)	2,297
Decrease (increase) in inventory	649	(1,123)
Increase (decrease) in accounts payable	1,547	(2,781)
Increase (decrease) in accrued expenses and other liabilities	3,482	(3,616)
Decrease in deferred revenue		(374)
(Increase) decrease in other non-current liabilities	(127)	14
Increase in income tax liabilities		187
Net cash used in operating activities	(5,618)	(15,870)
Cash flows from investing activities
Purchases of equipment	(3)	(35)
Other		(1)
Net cash used in investing activities	(3)	(36)
Cash flows from financing activities
Proceeds from issuance of ordinary shares and warrants		1,643
Proceeds from at-the-market facility		595
Repayments of long-term borrowings	(4,853)
Equity transaction costs	1
Equity transaction costs		(44)
Net cash (used in) provided by financing activities	(4,852)	2,194
Effects of exchange rate changes on the balance of cash held in foreign currencies	(143)	(164)
Net decrease in cash, cash equivalents and restricted cash	(10,616)	(13,876)
Cash, cash equivalents, and restricted cash at beginning of period	12,537	47,834
Cash, cash equivalents and restricted cash at end of period	1,921	33,958
Supplemental disclosure of cash flow information:
Interest paid	162	123
Taxes paid		1
Equity transaction costs included in accounts payable and accrued expenses	$ 640	$ 795

Accrued Expenses and Other Current Liabilities

3 Months Ended

Mar. 31, 2023

Accrued Expenses and Other Current Liabilities

Accrued Expenses and Other Current Liabilities

4. Accrued Expenses and Other Current Liabilities

Accrued expenses and other current liabilities include the following:


		As of March 31,		As of December 31,
(in thousands)		2023		2022
Research and development related costs	$	363	$	707
Payroll and related costs		5,123		1,737
Accounting, tax and audit services		568		552
Manufacturing and inventory		8,628		8,113
Product returns		774		784
Government rebates		2,234		2,028
Other accrued gross to net		2,194		2,129
Other		939		1,291
Total accrued expenses and other current liabilities	$	20,823	$	17,341

Share-Based Payments - Stock-based Compensation Expense (Details) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Share-Based Payments
Share-based compensation expense	$ 999	$ 1,000
Research and development
Share-Based Payments
Share-based compensation expense	164	94
Selling, general and administrative
Share-Based Payments
Share-based compensation expense	$ 835	$ 906

Document and Entity Information - shares	3 Months Ended
Document and Entity Information - shares	Mar. 31, 2023	Apr. 30, 2023
Document And Entity Information
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Mar. 31, 2023
Document Transition Report	false
Entity File Number	001-37558
Entity Registrant Name	Nabriva Therapeutics plc
Entity Incorporation, State or Country Code	L2
Entity Address, Address Line One	25-28 North Wall Quay
Entity Address, Address Line Two	IFSC
Entity Address, City or Town	Dublin 1
Entity Address, Country	IE
Entity Tax Identification Number	00-0000000
Entity Address, Postal Zip Code	00000
City Area Code	353 1
Local Phone Number	649 2000
Title of 12(b) Security	Ordinary Shares, nominal value $0.01 per share
Trading Symbol	NBRV
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Shares Outstanding		3,201,456
Entity Central Index Key	0001641640
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2023
Document Fiscal Period Focus	Q1
Amendment Flag	false

Significant Arrangements and License Agreements

3 Months Ended

Mar. 31, 2023

Significant Arrangements and License Agreements

Significant Arrangements and License Agreements

10. Significant Arrangements and License Agreements

Er-Kim License Agreement

On July 13, 2022, the Company entered into an exclusive Distribution Agreement with Er-Kim Pharmaceuticals, or Er-Kim, for the oral and intravenous formulations of XENLETA. Under the terms of the agreement, Er-Kim gains exclusive rights to distribute XENLETA in nine countries, including Bulgaria, Croatia, Czechia, Greece, Hungary, Poland, Romania, Slovakia and Slovenia. Er-Kim also may distribute XENLETA to an additional five countries through a NPU program. The Company will be the exclusive supplier of XENLETA to Er-Kim.

Sales Promotion and Distribution Agreement with Merck & Co.

On July 15, 2020, the Company entered into a Distribution Agreement, with MSD and Supplier, each a subsidiary of Merck. Under the Distribution Agreement and subject to the satisfaction of certain conditions, MSD appointed the Company as its sole and exclusive distributor of certain products containing tedizolid phosphate as the active ingredient previously marketed and sold by Supplier and MSD under the trademark SIVEXTRO® for injection, intravenous use and oral use, or the Products, in the United States and its territories, or the SIVEXTRO Territory. SIVEXTRO is an oxazolidinone-class antibacterial indicated in adults and pediatric patients 12 years of age and older for the treatment of acute bacterial skin and skin structure infections caused by certain susceptible Gram-positive microorganisms.

On April 12, 2021, in accordance with the terms of the Distribution Agreement, the Company began exclusive distribution of SIVEXTRO under its own National Drug Code, or NDC, and the Company recognizes 100% of net product sales of SIVEXTRO in its results of operations. Subject to applicable law, the Company is entitled to determine the final selling prices of the Products charged by it to its customers at its sole discretion, subject to an overall annual limit on price increases, and will be solely responsible for sales contracting and all market access activities, including bidding, hospital listing and reimbursement. The Company is responsible for all costs related to the promotion, sale and distribution of the Products by it, as well as all costs required to meet its staffing obligations under the Distribution Agreement. Prior to the execution of the Letter Agreement, the Company was obligated to use commercially reasonable

efforts to promote and distribute the Products and to maximize the sales of the Products throughout the SIVEXTRO Territory and utilized a combination of its employees and assistance from Amplity Health, a contract sales organization, to comply with this obligation.

On January 31, 2023, the Company entered into the Letter Agreement which, among other things, converted its exclusive license to promote, distribute and commercialize SIVEXTRO to a non-exclusive license and provided for the termination of the Distribution Agreement, effective June 30, 2023.

China Region License Agreement

In March 2018, the Company entered into the China Region License Agreement, with Sinovant Sciences, Ltd., or Sinovant, an affiliate of Roivant Sciences, Ltd., to develop and commercialize lefamulin in the greater China region. As part of the China Region License Agreement, Nabriva Therapeutics Ireland DAC and Nabriva Therapeutics GmbH, the Company’s wholly owned subsidiaries, granted Sinovant an exclusive license to develop and commercialize, and a non-exclusive license to manufacture, certain products containing lefamulin, or the China Region Licensed Products, in the People’s Republic of China, Hong Kong, Macau, and Taiwan, together the Extended China Territory. In May 2021, the Company entered into an assignment, assumption and novation agreement, or the Assignment Agreement, pursuant to which the Company consented to the assignment by Sinovant, an affiliate of Roivant Sciences, Ltd., of the China Region License Agreement to develop and commercialize lefamulin in the greater China region to Sumitomo Pharmaceuticals (Suzhou), a wholly-owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd., or Sumitomo. Pursuant to the Assignment Agreement, the Company agreed to release Sinovant and its affiliates from their obligations under the China Region License Agreement and consented to Sumitomo Pharmaceuticals (Suzhou)’s assumption of such obligations. In addition, Sumitomo has agreed to guarantee all of the obligations of Sumitomo Pharmaceuticals (Suzhou) under the China Region License Agreement.

Under the China Region License Agreement, Sumitomo Pharmaceuticals (Suzhou) and the Company’s subsidiaries have established a joint development committee, or the JDC, to review and oversee development and commercialization plans in the Extended China Territory. The China Region License Agreement includes milestone events consisting of a non-refundable $5.0 million upfront payment, an additional $91.5 million in milestone payments upon the achievement of certain regulatory and commercial milestone events related to lefamulin for CABP, plus an additional $4.0 million in milestone payments if any China Region Licensed Product receives a second or any subsequent regulatory approval in the People’s Republic of China. The Company has received the $5.0 million upfront payment, a $1.5 million payment for the submission of a clinical trial application, or CTA, by Sinovant to the Chinese Food and Drug Administration, which was received in the first quarter of 2019 and a $5.0 million milestone payment in the third quarter of 2019 in connection with the FDA approval for lefamulin. The Company will also be eligible to receive low double-digit royalties on sales, if any, of China Region Licensed Products in the Extended China Territory. In December 2020, the Company announced the restructuring of its China Region License Agreement. The restructured agreement provided for additional manufacturing collaboration and regulatory support to be provided to the contract counterparty by the Company that is expected to help expedite the delivery of XENLETA to patients in greater China. The restructured agreement also accelerated $3.0 million of the $5.0 million milestone payment to the Company that was previously payable upon regulatory approval of XENLETA in China, including a non-refundable upfront payment of $1.0 million which was received in the fourth quarter of 2020 and a $1.0 million milestone achieved during the first quarter of 2021. During 2021, management determined that the remaining $1.0 million milestone payment was probable of achievement and therefore the Company is recognizing the $3.0 million of accelerated payments under the restructured agreement as collaboration revenue in the consolidated statements of operations over the estimated period the manufacturing collaboration and regulatory support will be provided to the contract counterparty based on the proportional performance of the underlying performance obligation. The remaining milestones of $86.0 million are tied to additional regulatory approvals and annual sales targets. The future regulatory and commercial milestone payments under the China Region License Agreement will be recorded during the period the milestones become probable of achievement.

Except for the manufacturing collaboration and regulatory support discussed above, Sumitomo Pharmaceuticals (Suzhou) will be solely responsible for all costs related to developing, obtaining regulatory approval of and commercializing China Region Licensed Products in the Extended China Territory and is obligated to use commercially

reasonable efforts to develop, obtain regulatory approval for and commercialize China Region Licensed Products in the Extended China Territory. The Company is obligated to use commercially reasonable efforts to supply, pursuant to supply agreements to be negotiated by the parties, to Sumitomo Pharmaceuticals (Suzhou) a sufficient supply of lefamulin for Sumitomo Pharmaceuticals (Suzhou) to manufacture finished drug products for development and commercialization of the China Region Licensed Products in the Extended China Territory.

Unless earlier terminated, the China Region License Agreement will expire upon the expiration of the last royalty term for the last China Region Licensed Product in the Extended China Territory, which the Company expects will occur in 2033. Following the expiration of the last royalty term, the license granted to Sumitomo Pharmaceuticals (Suzhou) will become non-exclusive, fully-paid, royalty-free and irrevocable. The China Region License Agreement may be terminated in its entirety by Sumitomo Pharmaceuticals (Suzhou) upon 180 days’ prior written notice at any time. Either party may, subject to specified cure periods, terminate the China Region License Agreement in the event of the other party’s uncured material breach. Either party may also terminate the China Region License Agreement under specified circumstances relating to the other party’s insolvency. The Company has the right to terminate the China Region License Agreement immediately if Sumitomo Pharmaceuticals (Suzhou) does not reach certain development milestones by certain specified dates (subject to specified cure periods). The China Region License Agreement contemplates that the Company will enter into ancillary agreements with Sumitomo Pharmaceuticals (Suzhou), including clinical and commercial supply agreements and a pharmacovigilance agreement.

Sunovion License Agreement

In March 2019, the Company entered into the Sunovion License Agreement with Sunovion. As part of the Sunovion License Agreement, Nabriva Therapeutics Ireland DAC, the Company’s wholly owned subsidiary, granted Sunovion an exclusive license under certain patent rights, trademark rights and know-how to commercialize certain products containing XENLETA in the forms clinically developed by the Company or any of its affiliates, or the Sunovion Licensed Products, in Canada in all uses in humans in CABP and in any other indication for which the Sunovion Licensed Products have received regulatory approval in Canada. Under the Sunovion License Agreement, Sunovion and DAC established a joint development committee, or the Sunovion JDC, to review and oversee regulatory approval and commercialization plans in Canada. Sunovion will be solely responsible for all costs related to obtaining regulatory approval of and commercializing Sunovion Licensed Products in Canada and is obligated to use commercially reasonable efforts to develop, obtain regulatory approval for, and commercialize Sunovion Licensed Product in Canada.

On November 7, 2019, the Company, through Sunovion, submitted a New Drug Submission, or NDS. Health Canada determined there was a screening deficiency in December 2019 and a response from the Company/Sunovion was provided on December 18, 2019 and acknowledged by Health Canada on January 13, 2020. The NDS approval occurred on July 10, 2020.

The Company identified two performance obligations at inception: (1) the delivery of the exclusive license to Sunovion, which the Company has determined is a distinct license of functional intellectual property that Sunovion has obtained control of; and, (2) the participation in the Sunovion JDC. The $1.0 million non-refundable upfront payment was allocated entirely to the delivery of the license as the Sunovion JDC deliverable was deemed to be de minimis. With the NDS approval that occurred on July 10, 2020, the Company received a regulatory milestone payment of $0.5 million. Any future regulatory and commercial milestone payments under the Sunovion License Agreement will be recorded during the period the milestones become probable of achievement.

Named Patient Program Agreement with WE Pharma Ltd.

On June 30, 2020 the Company announced that WE Pharma Ltd., or WEP Clinical, a specialist pharmaceutical services company, had signed an exclusive agreement with the Company to supply XENLETA on a named patient or expanded access basis in certain countries outside of the US, China, Canada, Bulgaria, Croatia, Czechia, Greece, Hungary, Poland, Romania, Slovakia and Slovenia. The Named Patient Program, or NPP, is designed to ensure that physicians, contingent on meeting the necessary eligibility criteria and receiving approval, can request IV or oral XENLETA on behalf of patients who live in certain countries where it is not yet available and have an unmet medical

need. On January 9, 2023, the Company provided WEP Clinical with notice of its intent to terminate the agreement in connection with the orderly wind down of its operations.

Commitments and Contingencies

3 Months Ended

Mar. 31, 2023

Commitments and Contingencies

Commitments and Contingencies

11. Commitments and Contingencies

Future minimum contractual obligations and commitments are as follows:


	Year Ending December 31,
(in thousands)	Total		Remainder of 2023		2024		2025		2026		2027		Thereafter
Operating lease obligations	$	498		498		—		—		—		—	$	—
XENLETA API purchase		39,746		3,368		3,368		4,776		4,776		4,776		18,682
Other contractual commitments		6,064		3,790		1,385		889		—		—		—
Total contractual commitments and contingencies	$	46,308	$	7,656	$	4,753	$	5,665	$	4,776	$	4,776	$	18,682

The Company has contractual commitments related primarily to contracts entered into with contract manufacturing organizations and contract research organizations in connection with the commercial manufacturing of XENLETA. The amounts included in the above table are based on the existing contractual terms included within the agreements. Also, some of these contracts are subject to early termination clauses exercisable at the discretion of the Company.

Due to the Company’s intention to wind down operations and pursue the asset sales of XENLETA and CONTEPO, some amounts have been accrued for at March 31, 2023 and December 31, 2022 to comply with ASC 330-10-35-17, Inventory Purchase Commitments, regarding potential losses that a reporting entity may sustain as a result of firm purchase commitments. As of March 31, 2023, the Company had $4.3 million accrued within accrued expenses and other current liabilities, relating to the estimated losses under the XENLETA purchase commitments. Some of these future contractual commitments and contingencies include contractual language that may mitigate the payments for the commitments and contingencies. Additionally, as part of the asset sale process some of the other contractual commitments may be transferred as part of any potential transactions, possibly releasing the Company from any future commitments. There cannot, however, be any assurance that the Company will be able to identify, negotiate or complete a sale of any of the Company’s assets or, if such an asset sale transaction does occur, that any such transaction will include release of, or otherwise mitigate, the Company’s contractual commitments under its agreements on favorable terms or at all.

XENLETA API Supply

On August 4, 2021, our wholly-owned subsidiary, Nabriva Therapeutics Ireland DAC, entered into an amendment, or the First Amendment, to its API Supply Agreement, or the Hovione Supply Agreement, with Hovione Limited, or Hovione, which provides for the long-term commercial supply of the active pharmaceutical ingredients, or API, for XENLETA. Under the First Amendment, Hovione agreed to cancel the Company’s May 2021 purchase order for XENLETA API, which represented the Company’s minimum purchase requirement under the Hovione Supply Agreement. In addition, pursuant to the First Amendment, Hovione agreed to reduce the Company’s annual minimum purchase requirements for XENLETA API to no minimum purchase requirement in 2021, by 50% from 2022 to 2024 and by 25% in 2025, in consideration for cash payments totaling €3.2 million and the right to a low single-digit royalty on total net sales of XENLETA in the United States for a period commencing on August 4, 2021 and ending on November 22, 2030, or the Royalty Term, which royalty payments shall be no greater than an aggregate of €10.0 million. If the aggregate amount of royalties payments received by Hovione under the First Amendment is less than an aggregate of €4.0 million, the Company is obligated to pay Hovione the difference in a lump sum payment at the end of the Royalty Term. In addition, pursuant to the First Amendment, Hovione agreed to extend the duration of the Hovione Supply Agreement from November 22, 2025 to November 22, 2030 with annual minimum purchase requirements for 2026 to 2030 at the newly agreed annual minimum purchase amount for 2025. Pursuant to the First Amendment, upon the occurrence of certain events of insolvency for us, any unpaid minimum annual commitment amounts and royalty amounts under the agreement will become immediately due and payable.

On November 11, 2022, the Company’s wholly-owned subsidiary, Nabriva Therapeutics Ireland DAC, entered into an amendment, or the Third Amendment, to the Hovione Supply Agreement. Under the Third Amendment, Hovione agreed to reduce the Company’s annual minimum purchase requirements for XENLETA API for certain geographies. In consideration for the reduced minimum purchase requirements, the Company granted Hovione the right to a low single-digit royalty on total net sales of XENLETA by the Company’s licensees outside of the United States to the extent that the commercial product of XENLETA sold by such licensees is manufactured with API obtained from a third party (or any finished commercial product containing API obtained from a third party) other than Hovione during the terms of the agreement.

Zavante Obligations

In connection with the acquisition of Zavante in July 2018, the Company is obligated to pay up to $97.5 million in contingent consideration to the former Zavante shareholders, of which $25.0 million would become payable upon the first approval of a NDA from the FDA for CONTEPO for any indication, or the Approval Milestone Payment, and an aggregate of up to $72.5 million would become payable upon the achievement of specified sales milestones, or the Net Sales Milestone Payments. The Company’s shareholders have approved the issuance of the Company’s ordinary shares in settlement of potential milestone payment obligations that may become payable in the future to former Zavante stockholders, including the Approval Milestone Payment which will be settled in Company ordinary shares. The Company also has the right to settle the Net Sales Milestone Payments in Company ordinary shares, except as otherwise provided in the Agreement and Plan of Merger, dated July 23, 2018, by and among Nabriva Therapeutics plc and certain of its subsidiaries and Zavante Therapeutics, Inc. and Cam Gallagher, solely in his capacity as representative of the former Zavante stockholders, or the “Merger Agreement”.

The Company is obligated to pay $3.0 million in cash upon marketing approval by the FDA with respect to any oral, intravenous or other form of fosfomycin, or the Zavante Products, and milestone payments of up to $26.0 million that may be settled in ordinary shares in the aggregate upon the occurrence of various specified levels of net sales with respect to the Zavante Products. In addition, Zavante is obligated to make annual royalty payments of a mid-single-digit percentage of net sales of Zavante Products, subject to adjustment based on net sales thresholds and with such percentage reduced to low single-digits if generic fosfomycin products account for half of the applicable market on a product-by-product and country-by-country basis. Zavante will also pay a mid-single-digit percentage of transaction revenue in connection with the consummation of the grant, sale, license or transfer of market exclusivity rights for a qualified infectious disease product (within the meaning of the 21^st Century Cures Act) related to a Zavante Product.

Litigation

As of the date of the filing this Quarterly Report on Form 10-Q, there are no material outstanding legal proceedings against the Company or its current officers or directors.

Consolidated Balance Sheets (Parenthetical) - $ / shares	Mar. 31, 2023	Dec. 31, 2022
Consolidated Balance Sheets
Ordinary stock, nominal value (in dollars per share)	$ 0.01	$ 0.01
Ordinary stock, authorized shares	12,000,000	12,000,000
Ordinary stock, issued shares	3,201,495	3,201,417
Ordinary stock, outstanding shares	3,201,495	3,201,417
Preferred stock, par value (in dollars per share)	$ 0.01	$ 0.01
Preferred stock, authorized shares	100,000,000	100,000,000
Preferred stock, issued shares	0	0
Preferred stock, outstanding shares	0	0

Revenues

3 Months Ended

Mar. 31, 2023

Revenues

Revenues

6. Revenues


	Three Months Ended
	March 31,
(in thousands)	2023		2022
Product revenue, net	$	7,561	$	7,040
Collaboration revenues		29		629
Research premium and grant revenue		—		351
Total revenues	$	7,590	$	8,020

For the three months ended March 31, 2023 and 2022, SIVEXTRO product revenues, net of gross-to-net accruals and adjustments for returns were $7.6 million and $7.0 million, respectively. The Company´s gross-to-net, or GTN, estimates are based upon information received from external sources (such as written or oral information obtained from the Company´s customers with respect to their period-end inventory levels and sales to end-users during the period), in combination with management’s informed judgments. Due to the inherent uncertainty of these estimates, the

actual amount incurred may be materially above or below the amount initially estimated when product revenues are originally recorded, then requiring prospective adjustments to the Company’s reported product revenues, net.

The Company sells its products to pharmaceutical wholesalers/distributors (i.e., the Company’s customers). The Company’s wholesalers/distributors in turn sell the Company’s products directly to clinics, hospitals, and private practices. Revenue from the Company’s product sales is recognized as physical delivery of product occurs (when the Company’s customer obtains control of the product), in return for agreed-upon consideration.

Collaboration revenues for the three months ended March 31, 2023 were less than $0.1 million. Collaboration revenues for the three months ended March 31, 2022 included $0.6 million related to the restructured China Region License Agreement, a portion of which is recognized over the estimated period the manufacturing collaboration and regulatory support will be provided to Sumitomo Pharmaceuticals (Suzhou).

- Definition

The entire disclosure of revenue from contract with customer to transfer good or service and to transfer nonfinancial asset. Includes, but is not limited to, disaggregation of revenue, credit loss recognized from contract with customer, judgment and change in judgment related to contract with customer, and asset recognized from cost incurred to obtain or fulfill contract with customer. Excludes insurance and lease contracts.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-URI https://asc.fasb.org/topic&trid=49130388

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 10
-URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130551-203045

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 13
-Subparagraph (b)(2)
-URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130556-203045

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 12
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130554-203045

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 9
-URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130550-203045

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 12
-Subparagraph (e)
-URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130554-203045

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 12
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130554-203045

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 12
-Subparagraph (d)
-URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130554-203045

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 15
-URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130558-203045

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 606
-SubTopic 10
-Section 50
-Paragraph 12
-Subparagraph (c)
-URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130554-203045

+ Details

Earnings (Loss) per Share

3 Months Ended

Mar. 31, 2023

Earnings (Loss) per Share

Earnings (Loss) per Share

9. Earnings (Loss) per Share

Basic and Diluted Loss per Share

For the three months ended March 31, 2023 and 2022, basic and diluted net loss per share was determined by dividing net loss by the weighted average number of shares outstanding during the period. Diluted net loss per share is the same as basic net loss per share during the periods presented as the effects of the Company’s potential ordinary share equivalents are antidilutive since the Company had net losses for each period presented below.


	Three Months Ended
	March 31,
(in thousands, except share and per share data)	2023		2022
Net loss for the period	$	(8,700)	$	(11,819)
Weighted average number of shares outstanding		3,201,495		2,351,766
Basic and diluted loss per share	$	(2.72)	$	(5.03)

The following ordinary share equivalents were excluded from the calculations of diluted loss per share as their effect would be anti-dilutive since the Company had net losses for each period presented below:


	Three Months Ended
	March 31,
	2023	2022
Stock option awards	74,526	78,082
Restricted share units	37,258	46,555
Warrants	262,384	424,774

Commitments and Contingencies - Additional Lease Disclosures and Other Commitments and Contingencies (Details) $ in Thousands	Mar. 31, 2023 USD ($)
Operating lease obligations
Total	$ 498
2023	498
XENLETA API purchase
Total	39,746
2023	3,368
2024	3,368
2025	4,776
2026	4,776
2027	4,776
Thereafter	18,682
Other contractual commitments
Total	6,064
2023	3,790
2024	1,385
2025	889
Future minimum contractual obligations and commitments
Total contractual commitments and contingencies	46,308
2023	7,656
2024	4,753
2025	5,665
2026	4,776
2027	4,776
Thereafter	18,682
Accrued expense and other current liabilities
Future minimum contractual obligations and commitments
Total contractual commitments and contingencies	$ 4,300

Share-Based Payments - Stock Options (Details) - Stock Options - USD ($) $ / shares in Units, $ in Millions	3 Months Ended	12 Months Ended
	Mar. 31, 2023	Dec. 31, 2022
Options
Outstanding at beginning of year (in shares)	75,873
Cancelled and forfeited (in shares)	(1,347)
Outstanding at end of year (in shares)	74,526	75,873
Vested and exercisable at end of year (in shares)	65,364
Weighted average exercise price in $ per share
Outstanding balance at beginning of year (in dollars per share)	$ 351.24
Cancelled and forfeited (in dollars per share)	341.84
Outstanding balance at end of year (in dollars per share)	347.06	$ 351.24
Vested and exercisable balance at end of year (in dollars per share)	$ 391.51
Weighted Average Remaining Contractual Term (in years)
Weighted average remaining contractual term, outstanding	7 years 6 months	7 years 8 months 12 days
Weighted average remaining contractual term, vested and exercisable	6 years 10 months 24 days
Additional disclosures
Total unrecognized compensation related to unvested options	$ 0.2
Recognition period	1 year 6 months
Exercise Price Range From 11.25 To 2,750.00
Additional disclosures
Exercise price maximum range	$ 2,750.00
Exercise price minimum range	$ 11.25

Organization and Business Activities

3 Months Ended

Mar. 31, 2023

Organization and Business Activities

Organization and Business Activities

1. Organization and Business Activities

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 two approved products, SIVEXTRO and XENLETA, as well as one development product candidate, CONTEPO. The Company’s headquarters are located at Alexandra House, Office 225/227, The Sweepstakes, Dublin 4, Ireland.

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 has reduced its operations to those necessary to: (i) make SIVEXTRO and XENLETA commercially available to wholesale customers; (ii) identify and explore, with the assistance of Torreya Capital, a range of strategic options, including the sale, license or other disposition of one or more of its assets, technologies or products, including XENLETA and CONTEPO; and (iii) wind down its business. The Company has no intention of resuming any active sales promotion or research and development activities. Also as part of the Cash Preservation Plan, the Company’s board of directors determined to terminate all of the Company’s employees not deemed necessary to execute an orderly wind down of the Company’s operations, including Theodore Schroeder, the Company’s former chief executive officer, and Steven Gelone, the Company’s former president and chief operating officer, each of whom was terminated effective January 15, 2023. 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 the selling, general and administrative expenses in the statement of operations for the three months ended March 31, 2023. As of March 31, 2023 the remaining balance of severance costs associated with the wind down of our operations is approximately $3.8 million which is recorded in accrued expenses and other current liabilities in the consolidated balance sheet.

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 & Dohme Corp., or the Supplier, to begin transition responsibility for the promotion and distribution of SIVEXTRO back to Merck & Co. Inc., or Merck, as of June 30, 2023. Although the Company has ceased its active commercialization efforts, the Company expects to continue to make XENLETA and, for the remaining term of the Distribution Agreement, SIVEXTRO commercially available to wholesale customers.

As previously disclosed, the Company has retained Torreya Capital to advise on its exploration of a range of strategic options. While the Company continues to work with Torreya Capital on identifying and evaluating potential strategic options with the goal of maximizing value, the Company is currently focused, as part of its Cash Preservation Plan, on the sale of its existing assets, including XENLETA and CONTEPO. In the event that the Company’s board of directors determines that a liquidation and dissolution of the Company’s business approved by shareholders is the best method to maximize shareholder value, the Company would file proxy materials with the Securities and Exchange Commission and schedule an extraordinary meeting of its shareholders to seek approval of such a plan as required.

Liquidity

Since its inception, the Company has incurred net losses and generated negative cash flows from its operations which has resulted in a significant accumulated deficit to date, as well as total stockholders’ deficit. The Company has financed its operations through the sale of equity securities, convertible and term debt financings and research and development

support from governmental grants and proceeds from its licensing agreements and XENLETA and SIVEXTRO product sales. As of March 31, 2023, the Company had cash, cash equivalents and restricted cash of $1.9 million.

The Company follows the provisions of Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or ASC, Topic 205-40, Presentation of Financial Statements- Going Concern, 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, if it does not monetize at least one of the Company’s assets. These 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. The Company aims to complete an asset monetization deal; however, completing an asset monetization is not entirely within the Company’s control. Therefore, the Company may not have sufficient cash flows to fund its operations for the next twelve months after the date the consolidated financial statements are issued and therefore, 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.

While the Company has raised capital in the past, the ability to raise capital in future periods is not considered probable, as defined under the accounting standards. As such, under the requirements of ASC 205-40, management may not consider the potential for future capital raises in their assessment of the Company’s ability to meet its obligations for the next twelve months.

In May 2021, the Company entered into an Open Market Sale Agreement, or the Sale Agreement, with Jefferies, LLC, or Jefferies as agent, pursuant to which the Company may offer and sell ordinary shares, for aggregate gross sale proceeds of up to $50.0 million, from time to time through Jefferies, by any method permitted that is deemed an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended. As of

March 31, 2023, the Company has issued and sold an aggregate of 1,429,729 ordinary shares pursuant to the Sale Agreement and received gross proceeds of $33.9 million and net proceeds of $32.5 million, after deducting commissions to Jefferies and other offering expenses. From April 1, 2023 and through the date of this filing, the Company did not sell any shares under the Sale Agreement.

In September 2021, the Company entered into a purchase agreement, or Purchase Agreement, with Lincoln Park Capital Fund, LLC, or Lincoln Park, which, subject to the terms and conditions, provides that the Company has the right to sell to Lincoln Park and Lincoln Park is obligated to purchase up to $23.0 million of its ordinary shares. In addition, under the Purchase Agreement, the Company agreed to issue a commitment fee of 25,298 ordinary shares, or the Commitment Shares, as consideration for Lincoln Park entering into the Purchase Agreement and for the payment of $0.01 per Commitment Share. Under the Purchase Agreement, the Company may from time to time, at its discretion, direct Lincoln Park to purchase on any single business day, or a Regular Purchase, up to (i) 16,000 ordinary shares if the closing sale price of its ordinary shares is not below $0.25 per share on Nasdaq, (ii) 24,000 ordinary shares if the closing sale price of its ordinary shares is not below $50.00 per share on Nasdaq or (iii) 32,000 ordinary shares if the closing sale price of its ordinary shares is not below $75.00 per share on Nasdaq. Notwithstanding the foregoing, the Company may direct Lincoln Park to purchase on any single business day ordinary shares with a purchase price equal to or greater than $200,000 irrespective of the number of ordinary shares required to approximate that amount. In addition to Regular Purchases, the Company may also direct Lincoln Park to purchase other amounts as accelerated purchases or as additional accelerated purchases on the terms and subject to the conditions set forth in the Purchase Agreement. In any case, Lincoln Park’s commitment in any single Regular Purchase may not exceed $2.5 million absent a mutual agreement to increase such amount. As of March 31, 2023, the Company has issued and sold an aggregate of 320,000 ordinary shares pursuant to the Purchase Agreement and received net proceeds of $4.6 million. From April 1, 2023 and through the date of this filing, the Company did not sell any shares under the Purchase Agreement.

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 together with its anticipated SIVEXTRO and XENLETA commercial sales receipts will be sufficient to enable the Company to fund its operating expenses, debt service obligations and capital expenditure requirements through the end of June 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 through grants and clinical trial support, collaboration agreements or from the monetization of one or more of its assets. 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.

Income Tax Expense (Details) $ in Thousands	3 Months Ended
Income Tax Expense (Details) $ in Thousands	Mar. 31, 2022 USD ($)
Income Tax Expense
Income tax expense (benefit)	$ 354

- Definition

Amount of current income tax expense (benefit) and deferred income tax expense (benefit) pertaining to continuing operations.

+ References + Details

Income Tax Expense

3 Months Ended

Mar. 31, 2023

Income Tax Expense

Income Tax Expense

8. Income Tax Expense

For the three months ended March 31, 2023, the Company did not record a tax expense. For the three months ended March 31, 2022, the Company recorded a tax expense of $0.4 million.

Deferred tax assets and deferred tax liabilities are recognized based on temporary differences between the financial reporting and tax bases of assets and liabilities using statutory rates. Management of the Company has evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets, including the Company’s history of losses and concluded that it is more likely than not that the Company will not recognize the benefits of its deferred tax assets. On the basis of this evaluation the Company has recorded a valuation allowance against all of its deferred tax assets at March 31, 2023 and December 31, 2022.

- Definition

The entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section 50
-Paragraph 21
-URI https://asc.fasb.org/extlink&oid=121826272&loc=d3e32857-109319

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section S99
-Paragraph 2
-Subparagraph (SAB Topic 11.C)
-URI https://asc.fasb.org/extlink&oid=122134291&loc=d3e330215-122817

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section 50
-Paragraph 17
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=121826272&loc=d3e32809-109319

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SAB TOPIC 6.I.5.Q1)
-URI https://asc.fasb.org/extlink&oid=122134291&loc=d3e330036-122817

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 10
-Section 50
-Paragraph 14
-URI https://asc.fasb.org/extlink&oid=121826272&loc=d3e32705-109319

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 270
-Section 50
-Paragraph 1
-URI https://asc.fasb.org/extlink&oid=6424409&loc=d3e44925-109338

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-URI https://asc.fasb.org/topic&trid=2144680

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 740
-SubTopic 30
-Section 50
-Paragraph 2
-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=6424122&loc=d3e41874-109331

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 235
-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(h)(2))
-URI https://asc.fasb.org/extlink&oid=120395691&loc=d3e23780-122690

+ Details

Organization and Business Activities (Details) - USD ($)	1 Months Ended			3 Months Ended
	Jan. 31, 2023	Sep. 30, 2021	May 31, 2021	Mar. 31, 2023	Mar. 31, 2022	Dec. 31, 2022	Dec. 31, 2021
Liquidity
Severance costs	$ 5,400,000			$ 3,800,000
Cash and cash equivalents and restricted cash				$ 1,921,000	$ 33,958,000	$ 12,537,000	$ 47,834,000
Shares issued					$ 2,221,000
Research and development
Liquidity
Severance costs	1,300,000
Selling, general and administrative
Liquidity
Severance costs	$ 4,100,000
Lincoln Park Capital Fund, LLC \| Purchase agreement \| Ordinary shares
Liquidity
Number of shares issued				320,000
Net proceeds from sale of stock				$ 4,600,000
Commitment shares		25,298
Commitment share price		$ 0.01
Regular purchase		$ 2,500,000
Lincoln Park Capital Fund, LLC \| Purchase agreement \| Ordinary shares \| Minimum
Liquidity
Shares issued		200,000
Lincoln Park Capital Fund, LLC \| Purchase agreement \| Ordinary shares \| Maximum
Liquidity
Shares issued		$ 23,000,000.0
Lincoln Park Capital Fund, LLC \| Purchase agreement \| Ordinary shares \| Share Price Not Below $0.25 Per Share
Liquidity
Share price		$ 0.25
Lincoln Park Capital Fund, LLC \| Purchase agreement \| Ordinary shares \| Share Price Not Below $0.25 Per Share \| Maximum
Liquidity
Number of shares issued		16,000
Lincoln Park Capital Fund, LLC \| Purchase agreement \| Ordinary shares \| Share Price Not Below $2.00 Per Share
Liquidity
Share price		$ 50.00
Lincoln Park Capital Fund, LLC \| Purchase agreement \| Ordinary shares \| Share Price Not Below $2.00 Per Share \| Maximum
Liquidity
Number of shares issued		24,000
Lincoln Park Capital Fund, LLC \| Purchase agreement \| Ordinary shares \| Share Price Not Below $3.00 Per Share
Liquidity
Share price		$ 75.00
Lincoln Park Capital Fund, LLC \| Purchase agreement \| Ordinary shares \| Share Price Not Below $3.00 Per Share \| Maximum
Liquidity
Number of shares issued		32,000
Open Market Sale Agreement \| Jefferies LLC \| Ordinary shares
Liquidity
Number of shares issued				1,429,729
Proceeds from at-the-market facility				$ 32,500,000
Aggregate gross sale proceeds for ordinary shares				$ 33,900,000
Open Market Sale Agreement \| Jefferies LLC \| Ordinary shares \| Maximum
Liquidity
Aggregate gross sale proceeds for ordinary shares			$ 50,000,000.0

Share-Based Payments - Employee Stock Purchase Plan (Details) - Employee Stock Purchase Plan - shares	1 Months Ended	3 Months Ended
	Aug. 31, 2018	Mar. 31, 2023
Share-Based Payments
Maximum number of shares authorized under plan (in shares)	2,000
Purchase discount as a percentage of current market price		15.00%

Consolidated Statements of Operations - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Revenues:
Total revenues	$ 7,590	$ 8,020
Operating expenses:
Cost of revenues	(4,438)	(3,361)
Research and development expenses	(2,625)	(3,517)
Selling, general and administrative expenses	(9,002)	(12,700)
Total operating expenses	(16,065)	(19,578)
Loss from operations	(8,475)	(11,558)
Other income (expense):
Other income (expense), net	(31)	308
Interest expense, net	(194)	(215)
Loss before income taxes	(8,700)	(11,465)
Income tax expense		(354)
Net loss	$ (8,700)	$ (11,819)
Loss per share
Basic loss ($ per share)	$ (2.72)	$ (5.03)
Diluted loss ($ per share)	$ (2.72)	$ (5.03)
Weighted average number of shares:
Basic (in shares)	3,201,495	2,351,766
Diluted (in shares)	3,201,495	2,351,766
Product revenue, net
Revenues:
Total revenues	$ 7,561	$ 7,040
Collaboration revenue
Revenues:
Total revenues	$ 29	629
Research premium and grant revenue
Revenues:
Total revenues		$ 351