Components of Our Results of Operations
Sales Revenue
Grant Revenue
We expect that a portion of our revenue for the next few years will continue to be derived from payments under our government awards that we have currently entered into and that we may enter into in the future.
Collaboration Revenue
Collaboration revenue relates to our agreements with Everest, Pfizer and GSK.
Operating Expenses
Research and Development Expenses
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employee-related expenses, including salaries, related benefits, travel and share-based compensation expense for employees engaged in research and development functions;
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expenses incurred in connection with the preclinical and clinical development of our product candidates, including under agreements with contract research organizations (“CROs”);
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costs incurred in connection with our government awards;
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the cost of consultants and contract manufacturing organizations (“CMOs”) that manufacture drug products for use in our preclinical studies and clinical trials;
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facilities, depreciation and other expenses, which include direct and allocated expenses for rent and maintenance of facilities, insurance and supplies; and
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payments made under third-party licensing agreements.
Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials.
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receipt of marketing approvals from applicable regulatory authorities;
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establishment of arrangements with third-party manufacturers to obtain manufacturing supply;
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protection of our rights in our intellectual property portfolio;
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launch of commercial sales our product candidates, if approved, whether alone or in collaboration with others;
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acceptance of our product candidates, if approved, by patients, the medical community and third-party payors;
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competition with other therapies; and
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a continued acceptable safety profile of tebipenem HBr and our other product candidates, if approved.
A change in the outcome of any of these variables with respect to the development of any of our product candidates would significantly change the costs and timing associated with the development of that product candidate. We may never succeed in obtaining regulatory approval for any of our product candidates.
General and Administrative Expenses
Restructuring
Other Income (Expense), Net
Income Taxes
Critical Accounting Policies and Significant Judgments and Estimates
We believe that the following accounting policies are those most critical to the judgments and estimates used in the preparation of our financial statements.
Funding Received from Government Contracts and Collaborations
Government Contracts
Collaboration Agreements
Revenue Recognition – GSK License Agreement
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vendors in connection with the preclinical development activities;
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CMOs in connection with the production of preclinical and clinical trial materials;
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CROs in connection with preclinical and clinical studies; and
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investigative sites in connection with clinical trials.
Share-Based Compensation
Restructuring
Results of Operations
Comparison of the Years Ended
Collaboration Revenue
Research and Development Expenses
Total research and development expenses
Facility-related and other costs primarily reflect costs related to supporting our research and development staff.
General and Administrative Expenses
Total general and administrative expenses
The decrease in professional and consultant fees of
Facility-related and other costs primarily reflect costs related to supporting our general and administrative staff.
Restructuring
Other Income (Expense), Net
Liquidity and Capital Resources
Below is a summary of some of the items impacting our liquidity and capital resources in 2022:
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Cash Flows
7,672
84,050
Net increase (decrease) in cash and cash equivalents
Investing Activities
Financing Activities
Net cash used in financing activities for the year ended
Funding Requirements
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the timing and costs of our ongoing and planned clinical trials;
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the initiation, progress, timing, costs and results of preclinical studies and clinical trials of our product candidates and potential new product candidates;
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the amount of funding that we receive under government contracts that we have applied for;
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the number and characteristics of product candidates that we pursue;
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the outcome, timing and costs of seeking regulatory approvals;
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the costs of commercialization activities for our product candidates if we receive marketing approval, including the costs and timing of establishing product sales, marketing, distribution and manufacturing capabilities;
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the terms and timing of any future collaborations, licensing or other arrangements that we may establish;
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the costs of preparing, filing and prosecuting patent applications, maintaining and protecting our intellectual property rights and defending against any intellectual property related claims;
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the costs of operating as a public company; and
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the extent to which we in-license or acquire other products and technologies.
financings or other arrangements when needed, we may be required to delay, limit, reduce or terminate our research, product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
Contractual Obligations and Commitments
thousands)
Reflects payments due for our lease of office space under an operating lease agreement that expires in 2027.
Under our agreement with Vertex, we are obligated to make future milestone payments of up to
Recently Adopted Accounting Pronouncements
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