AGILE THERAPEUTICS, INC. The following discussion and analysis of financial condition and results of operations is provided to enhance the understanding of, and should be read in conjunction with, Part I, Item 1, "Business" and Item 8, "Financial Statements and Supplementary Data." For information on risks and uncertainties related to our business that may make past performance not indicative of future results or cause actual results to differ materially from any forward-looking statements, see "Special Note Regarding Forward-Looking Statements," and Part I, Item 1A, "Risk Factors." Dollars in tabular format are presented in thousands, except per share data, or as otherwise indicated.
Overview
We are a women's healthcare company dedicated to fulfilling the unmet health needs of today's women. Twirla® and our potential product candidates are designed to provide women with contraceptive options that offer greater convenience and facilitate compliance. Twirla, our first and only approved product, is a once-weekly prescription combination hormonal contraceptive patch. Twirla is designed using our proprietary transdermal patch technology, called Skinfusion®, designed with properties to optimize patch adhesion and patient wearability, which may help support compliance while, for the first time, delivering a dose of estrogen consistent with commonly prescribed combined hormonal contraceptives, or CHCs. We believe there is an unmet market need for a contraceptive patch that is designed to delivers approximately 30 mcg of estrogen and 120 mcg of progestin in a convenient dosage form that may support compliance in a non-invasive fashion.
Twirla was approved for sale in
As part of Twirla's approval, the FDA is requiring us to conduct a long-term
prospective, observational post-marketing study comparing the risks for VTE and
ATE in new users of Twirla to new users of other CHCs. The
With the approval of Twirla we now plan to focus on our transition from a clinical development stage company to a commercial company. During 2020, we plan to begin the implementation of our
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commercialization plan for Twirla and to manage the growth of our company. Our near term plan for the commercialization of Twirla includes:
Activity Expected Timing
Initiate coverage and reimbursement First Quarter 2020
activities in the United States from
third-party payors.
Initiate hiring of contract sales Second Quarter 2020
force
Complete pre-validation and validation Second Half 2020 with first shipment of the commercial manufacturing
of product in the Fourth Quarter 2020.
process consistent with our approved
marketing application
Our short-term goal is to establish an initial franchise in the
multi-billion-dollar
Our current priorities are as follows:
º •
º Successfully complete the pre-validation and validation process for
the commercial manufacturing of Twirla;
º •
º Obtain coverage and reimbursement for Twirla in the United States from
third-party payors;
º •
º Implement our commercialization plans for Twirla to ensure a
successful launch in the United States , including building a sales and
marketing team and implementing a healthcare compliance program;
º •
º Establish a supply chain for Twirla that will support
commercialization across the United States at launch;
º •
º Complete the design and protocol of the FDA-required post-marketing
long-term observational study comparing risks for VTE and ATE in new
users of Twirla to new users of other CHCs;
º •
º Explore the advancement of our existing pipeline and its possible
expansion through business development activities.
For more information about the regulatory history of Twirla, please see Part 1, Item 1, "Business"
Financial Overview
Since our inception in 1997, we have devoted substantial resources to
developing and seeking regulatory approval for Twirla, building our intellectual
property portfolio, business planning, raising capital and providing general and
administrative support for these operations. We incurred research and
development expenses of
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substantial amount of our resources are currently dedicated to completing manufacturing validation and commercializing Twirla.
We have funded our operations primarily through sales of common stock,
convertible preferred stock, convertible promissory notes and term loans. As of
In
In
In
In
In
We have not generated any revenue and have never been profitable for any
year. Our net loss was
Going Concern
As of
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operating needs beyond 2020, which we expect primarily will consist of commercializing Twirla, and exploring the advancement of our existing pipeline and its possible expansion through business development activities.
Our future success depends on our ability to raise additional capital and/or implement various strategic alternatives. Our ability to continue operations beyond 2020 will depend on our ability to obtain additional funding, as to which no assurances can be given. Based upon the foregoing, management has concluded that there is substantial doubt about our ability to continue as a going concern for twelve months from the date of filing of this Annual Report on Form 10-K. There can be no assurance that any financing by us can be realized, or if realized, what the terms of any such financing may be, or that any amount that we are able to raise will be adequate.
We continue to analyze strategic and financing alternatives, potential asset sales as well as mergers and acquisitions. We cannot be certain that these initiatives or raising additional capital, whether through selling additional debt or equity securities or obtaining a line of credit or other loan, will be available to us or, if available, will be on terms acceptable to us. If we issue additional securities to raise funds, whether through the issuance of equity or convertible debt securities, or any combination thereof, these securities may have rights, preferences, or privileges senior to those of our common stock, and our current stockholders will experience dilution. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through collaborations, strategic alliances or licensing arrangements with pharmaceutical partners, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates, including Twirla, or grant licenses on terms that may not be favorable to us. If we are unable to obtain funds when needed or on acceptable terms, we then may be unable to complete the commercialization of Twirla and may also be required to further cut operating costs, forego future development and other opportunities and may need to seek bankruptcy protection.
The financial statements as of
We do not own any manufacturing facilities and rely on our contract
manufacturer, Corium, for all aspects of the manufacturing of Twirla. We will
need to continue to invest in the manufacturing process for Twirla, and incur
significant expenses, in order to complete the validation of Corium's commercial
manufacturing line for Twirla and be capable of supplying projected commercial
quantities of Twirla. In
We have incurred and will continue to incur additional costs associated with operating as a public company. Accordingly, we will need additional capital to support our continuing operations and other potential product candidates in our pipeline in addition to the commercial activities required for the pre-launch and launch of Twirla. We will seek to fund our operations through public or private equity or debt financings or other sources, which may include collaborations with third parties. Adequate additional capital may not be available to us on acceptable terms, or at all. Our failure to raise additional capital as and when needed would have a negative impact on our financial condition and our
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ability to pursue our business strategy. We will need to generate significant revenue to achieve profitability, and we may never do so.
Financial Operations Overview
Revenue
To date, we have not generated any revenue. In the future, we may generate revenue from product sales, license fees, milestone payments and royalties from the sale of products developed using our intellectual property. Our ability to generate revenue and become profitable depends on our ability to successfully commercialize Twirla and any product candidates that we may advance in the future. If we fail to successfully commercialize Twirla, or any other product candidates we advance in a timely manner or obtain regulatory approval for them, our ability to generate future revenue, and our results of operations and financial position, will be adversely affected.
Research and Development Expenses
Since our inception, we have focused our resources on our research and development activities. Research and development expenses consist primarily of costs incurred for the development of Twirla and other current and future potential product candidates, and include:
º •
º expenses incurred under agreements with contract research
organizations, or CROs, and investigative sites that conduct our
clinical trials and preclinical studies;
º •
º employee-related expenses, including salaries, benefits, travel and
stock-based compensation expenses;
º •
º the cost of acquiring, developing and manufacturing clinical trial
materials, including the supply of our potential product candidates;
º •
º costs associated with research, development and regulatory activities;
and
º •
º costs associated with equipment scale-up required for commercial
manufacturing.
Research and development costs are expensed as incurred. Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using data such as subject enrollment, clinical site activations or information provided to us by our third-party vendors.
Research and development activities are central to our business model and to date, our research and development expenses have been related primarily to the development of Twirla. 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. We do not currently utilize a formal time allocation system to capture expenses on a project-by-project basis, as the majority of our past and planned expenses have been and will be in support of Twirla.
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For the years ended
Year ended December 31,
2019 2018 2017
(In thousands)
Clinical development $ 1,781 $ 1,318 $ 2,386
Regulatory 2,990 562 1,348
Personnel related 1,669 2,162 2,440
Manufacturing-commercialization 2,876 4,306 5,917
Manufacturing 20 155 1,153
Stock-based compensation 522 1,274 1,184
Total research and development expenses $ 9,858 $ 9,777 $ 14,428 It is difficult to determine with any certainty the exact duration and completion costs of any of our future clinical trials of Twirla or our current and future potential product candidates we may advance. It is also difficult to determine if, when or to what extent we will generate revenue from the commercialization and sale of Twirla our potential product candidates that obtain regulatory approval.
The duration, costs and timing of clinical trials and development of our other potential product candidates in addition to conducting required post-marketing studies for Twirla will depend on a variety of factors, including the uncertainties of future clinical trials and preclinical studies, the rate of subject enrollment, obtaining additional capital, and significant and changing government regulation. In addition, the probability of success for each product candidate will depend on numerous factors, including competition, manufacturing capability and commercial viability. A change in the outcome of any of these variables with respect to the development of a product candidate could mean a significant change in the costs and timing associated with the development of that product candidate. For example, if the FDA, or another regulatory authority were to require us to conduct clinical trials beyond those that we currently anticipate will be required for the completion of clinical development of a product candidate, or if we experience significant delays in enrollment in any of our clinical trials, or experience issues with our manufacturing capabilities we could be required to expend significant additional financial resources and time with respect to the development of that product candidate. We will determine which programs to pursue and how much to fund each program in response to the scientific and clinical success of each product candidate, as well as an assessment of each product candidate's commercial potential. Substantially all of our resources are currently dedicated to commercializing Twirla. We will require additional capital to fund our operating needs beyond 2020, which we expect primarily will consist of commercializing Twirla, and exploring the advancement of our existing pipeline and its possible expansion through business development activities.
General and Administrative Expenses
General and administrative expenses consist principally of salaries and related costs for personnel in executive, finance and administrative functions including payroll taxes and health insurance, stock-based compensation and travel expenses. Other general and administrative expenses include facility-related costs, insurance and professional fees for legal, patent review, consulting and accounting services. General and administrative expenses are expensed as incurred.
For the years ended
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the 2017 CRL and receive approval of Twirla. With the recent approval of Twirla,
we intend to commercialize Twirla in
Critical Accounting Policies and Significant Judgments and Estimates
Our discussion and analysis of our financial condition and results of
operations are based on our financial statements, which have been prepared in
accordance with
Our significant accounting policies are described in more detail in the notes to our financial statements appearing elsewhere in this Annual Report on Form 10-K. We believe the following accounting policies to be most critical to the judgments and estimates used in the preparation of our financial statements.
As part of the process of preparing our financial statements, we are required to estimate our accrued expenses, particularly for product development costs. This process involves reviewing open contracts and purchase orders, communicating with our personnel to identify services that have been performed on our behalf and estimating the level of services performed and the associated costs incurred for the services when we have not yet been invoiced or otherwise notified of the actual costs. The majority of our service providers invoice us monthly in arrears for services performed or when contractual milestones are met. We make estimates of our accrued expenses as of each balance sheet date in our financial statements based on facts and circumstances known to us at that time. We periodically confirm the accuracy of our estimates with service providers and make adjustments as necessary. Examples of estimated accrued research and development expenses include:
º •
º fees paid to CROs in connection with clinical studies;
º •
º fees paid to investigative sites in connection with clinical studies;
º •
º fees paid to vendors in connection with preclinical development
activities;
º •
º fees paid to vendors related to product manufacturing, development and
distribution of clinical supplies; and
º •
º fees paid to a third-party manufacturer in connection with the
development of our commercial manufacturing process.
We base our expenses related to clinical studies on our estimates of the services received and efforts expended pursuant to contracts with multiple CROs that conduct and manage clinical studies on our behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. There may be instances in which payments made to our vendors will exceed the level of services provided and result in a prepayment of the clinical expense. Payments under some of these contracts depend on factors such as the successful enrollment of subjects and the completion of clinical trial milestones. In accruing service fees, we estimate the time period over which services will be performed, enrollment of subjects, number of sites activated and the level of effort to be expended in each period. If the actual timing of the performance of services or the
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level of effort varies from our estimate, we adjust the accrued liability or
prepaid expense accordingly. Although we do not expect our estimates to be
materially different from amounts actually incurred, our understanding of the
status and timing of services performed relative to the actual status and timing
of services performed may vary and may result in our reporting amounts that are
too high or too low in any particular period. Based on historical experience,
actual results have not been materially different from our estimates. As of
Warrant Liability
We account for warrants to purchase common stock in accordance with Accounting Standards Codification, or ASC, 480, Distinguishing Liabilities from Equity. ASC 480 requires that a financial instrument, other than an outstanding share, that, at inception, is indexed to an obligation to repurchase the issuer's equity shares, regardless of the timing or the probability of the redemption feature and may require the issuer to settle the obligation by transferring assets classified as a liability. We measure the fair value of our warrant liability using the Black-Scholes option-pricing model with changes in fair value recognized as increases or reductions to other income (expense) in the statement of operations.
In connection with the completion of our initial public offering in
The warrants issued in connection with our debt financing completed in
As part of the
Stock-Based Compensation
We account for stock-based compensation under ASC 718, Accounting for Stock Based Compensation, under which compensation expense is generally recognized over the vesting period of the award. Determining the amount of stock-based compensation to be required requires us to develop estimates of fair values of stock options as of the grant date.
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We account for stock-based compensation by measuring and recognizing expense
for all stock-based payments made to employees and directors based on estimated
grant date fair values. We use the straight-line method to allocate compensation
cost to reporting periods over each optionee's requisite service period, which
is generally the vesting period. We estimate the fair value of our stock-based
awards to employees and directors using the Black-Scholes option valuation
model, or Black-Scholes model. The Black-Scholes model requires the input of
subjective assumptions, including the expected stock price volatility, the
calculation of expected term and the fair value of the underlying common stock
on the date of grant, among other inputs. The risk-free interest rate was
determined with the implied yield currently available for zero-coupon
We also award restricted stock units ("RSUs") to employees and our board of directors (the "Board"). RSUs are generally subject to forfeiture if employment terminates prior to the completion of the vesting restrictions. We expense the cost of the RSUs, which is determined to be the fair market value of the shares of common stock underlying the RSUs at the date of grant, ratably over the period during which the vesting restrictions lapse. Cost associated with performance-based restricted stock units with a performance condition which affects the vesting is recognized only if the performance condition is probable of being satisfied.
Comparison of Years Ended
Year ended December 31,
2019 2018 Change
(In thousands)
Operating expenses:
Research and development $ 9,858 $ 9,777 $ 81
General and administrative 9,000 8,739 261
Restructuring costs - 1,019 (1,019 )
Total operating expenses 18,858 19,535 (677 )
Other income (expense)
Interest income 252 366 (114 )
Interest expense - (1,116 ) 1,116
Change in fair value of warrants - 29 (29 )
Total other income (expense), net 252 (721 ) 973
Loss before benefit from income taxes (18,606 ) (20,256 ) 1,650
Benefit from income taxes - 477 (477 )
Net loss $ (18,606 ) $ (19,779 ) $ 1,173 Research and development expenses. Research and development expenses
increased by
º •
º an increase in regulatory expense of $2.4 million for the year ended
December 31, 2019 as compared to the year ended December 31, 2018 .
This increase is primarily related to consulting fees incurred in
connection with the resubmission of our NDA for Twirla as well as
costs associated with the preparation for and attendance at the FDA
advisory committee meeting;
º •
º an increase in clinical development expenses of $0.5 million for the
year ended December 31, 2019 as compared to the year ended
December 31, 2018 . This increase primarily relates to the
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costs associated with the comparative wear study of Twirla and Xulane
which was initiated and completed during the first quarter of 2019;
º •
º a decrease in manufacturing commercialization expenses of $1.5 million
for the year ended December 31, 2019 as compared to the year ended
December 31, 2018 . This decrease from 2019 to 2018 reflects reduced
activity associated with the scale-up and on-going qualification of
the commercial manufacturing equipment primarily as a result of the
receipt of the 2017 CRL. Costs related to the qualification,
validation and manufacture of Twirla were recorded as research and
development expenses until we received approval for the Twirla NDA;
º •
º a decrease in stock compensation expense of $0.8 million for the year
ended December 31, 2019 as compared to the year ended December 31,
2018 . This decrease is primarily the result of a lower stock price
associated with the January 2019 stock option grants as compared to
the January 2018 stock option grants; and
º •
º a decrease in personnel-related expenses of $0.5 million for the year
ended December 31, 2019 as compared to the year ended December 31,
2018 . This decrease is primarily the result of the reduction in
workforce that was announced in June 2018 as part of our restructuring
efforts.
General and administrative expenses. General and administrative expenses
increased by
º •
º an increase in professional fee expense of $0.8 million for the year
ended December 31, 2019 as compared to the year ended December 31,
2018 . This increase primarily relates to the use of financial
consultants and recruiting and search fees;
º •
º an increase in advertising and promotion costs of $0.4 million for the
year ended December 31, 2019 compared to the year ended December 31,
2018 . This increase relates to additional promotional activities as we
prepared for the commercialization of Twirla;
º •
º an increase in insurance costs of $0.2 million for the year ended
December 31, 2019 compared to the year ended December 31, 2018 ; and
º •
º a decrease in stock compensation expense of $1.1 million for the year
ended December 31, 2019 compared to the year ended December 31, 2018 .
This decrease is primarily the result of a lower stock price
associated with the January 2019 stock option grants as compared to
the January 2018 stock option grants.
Restructuring costs. In
Interest income. Interest income comprises interest income earned on cash and cash equivalents.
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Interest expense. Interest expense was primarily attributable to our term
loan with Hercules for the year ended
Change in fair value of warrants. Prior to our adoption of Accounting
Standards Update, or ASU 2017-1, on
Benefit from income taxes. For the years ended
Comparison of Years Ended
Year ended December 31,
2018 2017 Change
(In thousands)
Operating expenses:
Research and development $ 9,777 $ 14,428 $ (4,651 )
General and administrative 8,739 12,383 (3,644 )
Restructuring costs 1,019 - 1,019
Total operating expenses 19,535 26,811 (7,276 )
Other income (expense)
Interest income 366 282 84
Interest expense (1,116 ) (1,918 ) 802
Change in fair value of warrants 29 143 (114 )
Total other income (expense), net (721 ) (1,493 ) 772
Loss before benefit from income taxes (20,256 ) (28,304 ) 8,048
Benefit from income taxes 477 - 477
Net loss $ (19,779 ) $ (28,304 ) $ 8,525
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Research and development expenses. Research and development expenses
decreased by
º •
º a decrease in manufacturing commercialization expenses of $2.4 million
for the year ended December 31, 2018 as compared to the year ended
December 31, 2017 . This decrease reflects reduced activity associated
with the scale-up process and the on-going qualification process of
the commercial manufacturing equipment primarily as a result of the
receipt of the 2017 CRL. Costs related to the qualification,
validation and manufacture of Twirla were recorded as research and
development expenses until we received approval for the Twirla NDA;
º •
º a decrease in clinical development expenses of $1.1 million for the
year ended December 31, 2018 as compared to the year ended
December 31, 2017 . This decrease primarily relates to the completion
of the close-out activities associated with our SECURE clinical trial
during 2017. There were no external costs related to the SECURE
clinical trial incurred during the year ended December 31, 2018 ; and
º •
º a decrease in regulatory expenses of $0.8 million for the year ended
December 31, 2017 as compared to the year ended December 31, 2018 .
This decrease primarily relates to reduction of regulatory activity
during the year ended December 31, 2018 as compared the year ended
December 31, 2017 . Regulatory expenses for the year ended December 31,
2017 included external costs associated with the preparation of our
NDA resubmission and response to the FDA's CRL received by us in
February 2013 .
General and administrative expenses. General and administrative expenses
decreased by 3.7 million, or 29%, from
º •
º a decrease in commercial development expense of $3.2 million for the
year ended December 31, 2018 as compared to the year ended
December 31, 2017 . This decrease relates to the suspension of our
pre-commercialization activities such as brand building, advocacy and
consulting as a result of the receipt of the 2017 CRL;
º •
º a decrease in professional fees expense of $0.8 million for the year
ended December 31, 2018 compared to the year ended December 31, 2017 .
This decrease is primarily the result of a reduction in the use of
consultants and lower legal and patent-related costs; and
º •
º an increase in personnel costs of $0.7 million for the year ended
December 31, 2018 compared to the year ended December 31, 2017 , which
partially offsets the decreases discussed above. This increase relates
to the addition of personnel during the second half of 2017 to help
prepare for launch of Twirla, if approved.
Restructuring costs. In
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represent
Interest income. Interest income comprises interest income earned on cash and cash equivalents.
Interest expense. Interest expense is primarily attributable to our term
loan with Hercules for the years ended
Change in fair value of warrants. Certain of our warrants to purchase
shares of our common stock are recorded at fair value and are subject to
re-measurement at each balance sheet date. These liabilities are re-measured at
each balance sheet date with the corresponding charge to earnings recorded
within change in fair value of warrant liability. The fair value of the common
stock warrants with non-standard anti-dilution provisions are determined using
the Black-Scholes option pricing model which incorporates a number of
assumptions and judgments to estimate the fair value of these warrants including
the fair value per share of the underlying stock, the remaining contractual term
of the warrants, risk-free interest rate, expected dividend yield, credit spread
and expected volatility of the price of the underlying stock. During the year
ended
Benefit from income taxes. For the year ended
Net Operating Losses and Tax Carryforwards
As of
On
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effective
Liquidity and Capital Resources
In
In
In
In
At
The following table sets forth the primary sources and uses of cash for the
periods indicated:
Year Ended December 31,
2019 2018 2017
(In thousands)
Net cash used in operating activities
(98 ) (318 ) (1,313 )
Net cash provided by (used in) financing
activities 42,415 (10,888 ) 13,075
Net increase (decrease) in cash and cash
equivalents $ 26,628 $ (28,101 ) $ (12,798 )
Operating Activities
We have incurred significant costs in the area of research and development,
including CRO fees, manufacturing, regulatory and other clinical trial costs, as
Twirla was being developed. Net cash used in operating activities was
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was offset, in part, by non-cash stock-based compensation expense of
Investing Activities
Net cash used in investing activities for the years ended
Financing Activities
Net cash provided by financing activities for the year ended
Funding Requirements and Other Liquidity Matters
We believe that our cash and cash equivalents as of
We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future. We anticipate that our expenses will increase substantially as we:
º •
º establish a sales and marketing infrastructure to commercialize Twirla
in the United States ;
º •
º continue the equipment qualification and validation related to
Corium's manufacturing facility in preparation for commercial
operations;
º •
º continue to evaluate additional line extensions for Twirla and
initiate development of potential product candidates in addition to
Twirla;
º •
º maintain, leverage and expand our intellectual property portfolio; and
º •
º add operational, financial and management information systems and
personnel, including personnel to support our product development and
future commercialization efforts.
We may also need to raise additional funds sooner if we choose to accelerate components of our commercial plan or we encounter any unforeseen events that affect our current business plan, or we may choose to raise additional funds to provide us with additional working capital. Adequate additional
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funding may not be available to us on acceptable terms, or at all. If we are unable to raise additional capital when needed or on attractive terms or are unable to enter into strategic collaborations, we then may be unable to successfully commercialize Twirla and may also be required to further cut operating costs, forgo future development and other opportunities or even terminate our operations, which may involve seeking bankruptcy protection. Because of the numerous risks and uncertainties associated with such developments, including, among other things, manufacturing scale up, we are unable to estimate the amounts of increased capital outlays and operating expenses associated with completing the commercialization of Twirla. Our future capital requirements will depend on many factors, including:
º •
º the costs of the equipment qualification and validation related to the
expansion of Corium's manufacturing facility in preparation for
commercial operations;
º •
º the costs of future commercialization activities, including the
commercial launch, product sales, marketing, manufacturing and
distribution, for Twirla;
º •
º the revenue, if any, received from commercial sales of Twirla;
º •
º the costs of preparing, filing and prosecuting patent applications,
maintaining and enforcing our intellectual property rights and
defending intellectual property-related claims; and
º •
º the costs associated with any potential business or product
acquisitions, strategic collaborations, licensing agreements or other
arrangements that we may establish.
Except for the remaining tranche under the Perceptive Credit Agreement, which is contingent upon achieving certain revenue milestones, we do not have any committed external source of funds. Until such time, if ever, as we can generate substantial cash flows from product revenues, we expect to finance our cash needs through a combination of equity offerings, debt financings, collaborations, strategic alliances and licensing arrangements.
Going Concern
As of
Our future success depends on our ability to raise additional capital and/or implement various strategic alternatives. We continue to analyze strategic and financing alternatives, potential asset sales as well as mergers and acquisitions. We cannot be certain that these initiatives or raising additional capital, whether through selling additional debt or equity securities or obtaining a line of credit or other loan, will be available to us or, if available, will be on terms acceptable to us. If we issue additional securities to raise funds, whether through the issuance of equity or convertible debt securities, or any combination thereof, these securities may have rights, preferences, or privileges senior to those of our common stock, and our current shareholders may experience dilution. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through collaborations, strategic alliances or licensing arrangements with pharmaceutical partners, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates, including Twirla, or grant licenses on terms that may not be favorable to us. If we are unable to obtain funds when needed or on acceptable terms, we may
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be required to curtail our current development programs, cut operating costs, forego future development and other opportunities and may need to seek bankruptcy protection.
The financial statements as of
Contractual Obligations and Commitments
The following table summarizes our contractual obligations and commitments
as of
Less than More than
Total 1 year 1 - 3 years 3 - 5 years 5 years
(In thousands)
Operating lease 191 191 - - -
Total $ 191 $ 191 $ - $ - $ -
Our operating lease commitment relates to our lease of office space in
Shelf Registration Statements
On
On
In
On
Recent Accounting Pronouncements
See Note 2 to our financial statements that discusses new accounting pronouncements.
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Off-Balance Sheet Arrangements
We did not have during the periods presented, and we do not currently have,
any off-balance sheet arrangements, as defined under
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