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TABLE OF CONTENTS
TABLE OF CONTENTS
Table of Contents
Filed Pursuant to Rule 424(b)(5)
Registration No. 333-205120
The information contained in this preliminary prospectus supplement and the accompanying prospectus is not complete and may be changed. A registration statement relating to the
securities has been declared effective by the Securities and Exchange Commission. This preliminary prospectus supplement and the accompanying prospectus do not constitute an offer to sell these
securities and we are not soliciting an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.
SUBJECT TO COMPLETION, DATED AUGUST 2, 2017
PRELIMINARY PROSPECTUS SUPPLEMENT
(To Prospectus dated July 1, 2015)
Shares
Common Stock
Agile Therapeutics, Inc. is offering of shares of common
stock.
Our
common stock is listed on The NASDAQ Global Market under the symbol "AGRX". The last reported sale price of our common stock on The NASDAQ Global Market on August 1, 2017 was
$4.60 per share.
We
are an emerging growth company as that term is used in the Jumpstart Our Business Startups Act of 2012 and, as such, have elected to comply with certain reduced public company
reporting requirements for this prospectus supplement and future filings.
Investing in our common stock involves a high degree of risk. See "Risk Factors" beginning on page S-6 and in the documents incorporated by reference in
this prospectus supplement.
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Per Share
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Total
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Public offering price
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$
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$
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Underwriting discounts and commissions(1)
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$
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$
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Offering proceeds to us, before expenses
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$
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$
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(1)
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We
refer you to the section entitled "Underwriting" beginning on page S-18 of this prospectus supplement for additional information regarding total
underwriter compensation.
Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this
prospectus is truthful or complete. Any representation to the contrary is a criminal offense.
We
have granted the underwriters the right to purchase up to of additional shares of common stock. The underwriters can exercise this
right at any time within
30 days after the offering. The underwriters expect to deliver the shares of common stock to investors on or about , 2017.
Joint Book-Running Managers
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William Blair
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RBC Capital Markets
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Cantor Fitzgerald & Co.
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, 2017
Table of Contents
TABLE OF CONTENTS
Neither we nor the underwriters have authorized anyone to provide any information or to make any representations other than those contained or incorporated by
reference in this prospectus supplement, the accompanying prospectus or in any free writing prospectuses we have authorized for use in connection with this offering. We take no responsibility for, and
can provide no assurance as to the reliability of, any other information that others may give you. This prospectus supplement and the accompanying prospectus together constitute an offer to sell only
the securities offered hereby, but only under circumstances and in jurisdictions where it is lawful to do so. The information contained in this prospectus supplement, the accompanying prospectus and
any free writing prospectuses that we have authorized for use in connection with this offering is current only as of its date. Our business, financial condition, results of operations and prospects
may have changed since those dates. You should read this prospectus supplement, the accompanying prospectus, the documents incorporated by reference herein and therein, and any free writing prospectus
that we have authorized for use in connection with this offering when making your investment decision. You should also read and consider the information in the documents we have referred you to in the
section of the accompanying prospectus entitled "Information Incorporated by Reference."
i
Table of Contents
ABOUT THIS PROSPECTUS SUPPLEMENT
This prospectus supplement and the accompanying prospectus form part of a registration statement on Form S-3 that we filed with the
Securities and Exchange Commission, or SEC, utilizing a "shelf" registration process. This document contains two parts. The first part consists of this prospectus supplement, which provides you with
specific information about this offering. The second part, the accompanying prospectus, provides more general information, some of which may not apply to this offering. Generally, when we refer only
to the "prospectus," we are referring to both parts combined. This prospectus supplement may add, update or change information contained in the accompanying prospectus. To the extent that any
statement we make in this prospectus supplement is inconsistent with statements made in the accompanying prospectus or any documents incorporated by reference herein or therein, the statements made in
this prospectus supplement will be deemed to modify or supersede those made in the accompanying prospectus and such documents incorporated by reference herein and therein. You should read this
prospectus supplement and the accompanying
prospectus, including the information incorporated by reference herein and therein, and any related free writing prospectus that we have authorized for use in connection with this offering.
You
should rely only on the information that we have included or incorporated by reference in this prospectus supplement, the accompanying prospectus and any related free writing
prospectus that we may authorize to be provided to you. We have not authorized any dealer, salesman or other person to give any information or to make any representation other than those contained or
incorporated by reference in this prospectus supplement, the accompanying prospectus or any related free writing prospectus that we may authorize to be provided to you. You must not rely upon any
information or representation not contained or incorporated by reference in this prospectus supplement, the accompanying prospectus or any related free writing prospectus. This prospectus supplement,
the accompanying prospectus and any related free writing prospectus do not constitute an offer to sell or the solicitation of an offer to buy any securities other than the registered securities to
which they relate, nor do this prospectus supplement, the accompanying prospectus or any related free writing prospectus constitute an offer to sell or the solicitation of an offer to buy securities
in any jurisdiction to any person to whom it is unlawful to make such offer or solicitation in such jurisdiction.
You
should not assume that the information contained in this prospectus supplement, the accompanying prospectus or any related free writing prospectus is accurate on any date subsequent
to the date set forth on the front of the document or that any information we have incorporated by reference herein or therein is correct on any date subsequent to the date of the document
incorporated by reference, even though this prospectus supplement, accompanying prospectus or any related free writing prospectus is delivered, or securities are sold, on a later date.
This
prospectus supplement contains or incorporates by reference summaries of certain provisions contained in some of the documents described herein, but reference is made to the actual
documents for complete information. All of the summaries are qualified in their entirety by the actual documents. Copies of some of the documents referred to herein have been or will be filed or have
been or will be incorporated by reference as exhibits to the registration statement of which this prospectus supplement forms a part, and you may obtain copies of those documents as described
in this prospectus supplement under the heading "Where You Can Find More Information."
ii
Table of Contents
SUMMARY
This summary highlights information contained in other parts of this prospectus supplement. Because it is only a
summary, it does not contain all of the information that you should consider before investing in shares of our common stock and it is qualified in its entirety by, and should be read in conjunction
with, the more detailed information appearing elsewhere in this prospectus supplement, the accompanying prospectus, any applicable free writing prospectus and the documents incorporated by reference
herein and therein. You should read all such documents carefully, especially the risk factors and our financial statements and the related notes included or incorporated by reference herein or
therein, before deciding to buy shares of our common stock. Unless the context requires otherwise, references in this prospectus to "Agile," "we," "us" and "our" refer to Agile
Therapeutics, Inc.
Company Overview
We are a forward-thinking women's healthcare company dedicated to fulfilling the unmet health needs of today's women. Our current product
candidates are designed to provide women with contraceptive options that offer greater convenience and facilitate compliance. We have developed a proprietary transdermal patch technology, called
Skinfusion®, which is designed to provide advantages over currently available patches and is intended to optimize patch adherence and stability as well as patient comfort. Our lead product
candidate, Twirla®, also known as AG200-15, is a once-weekly prescription contraceptive patch that is at the end of Phase 3 clinical development. Twirla is a combined hormonal
contraceptive, or CHC, patch that contains the active ingredients ethinyl estradiol, or EE, which is a synthetic estrogen, and levonorgestrel, or LNG, which is a type of progestin, a synthetic steroid
hormone, both of which have an established history of efficacy and safety in currently marketed combination low-dose, oral contraceptives.
Prior
to our SECURE clinical trial, as discussed below, we conducted a comprehensive clinical program and completed Phase 1, Phase 2 and Phase 3 trials, which
together enrolled over 2,100 women, over 1,500 of whom received Twirla. We have filed a Section 505(b)(2) New Drug Application, or NDA, for approval of Twirla by the U.S. Food and Drug
Administration, or FDA, which is required before marketing a new drug in the United States. Our 505(b)(2) NDA relies, in part, on clinical trials that we conducted and, in part, on the FDA's findings
of safety and efficacy from investigations for approved products containing the active ingredients and published scientific literature for which we have not obtained a right of reference. In February
2013, the FDA indicated in a Complete Response Letter, or CRL, that our NDA was not sufficient for approval as originally submitted. After multiple communications with the FDA, we received significant
guidance as to what additional clinical development and other activities need to be completed prior to approval.
In
accordance with the FDA's advice and comments, we conducted an additional Phase 3 clinical trial, referred to as the SECURE clinical trial, in which we enrolled over 2,000
women for up to one year of treatment. We announced top-line data in early January 2017. In March 2017, at our request, we met with the FDA to share preliminary data from the SECURE clinical trial,
including key safety data and body mass index-related efficacy findings, and to seek FDA input as to whether the SECURE clinical trial results constitute a basis for addressing the clinical
deficiencies cited in the CRL. We also requested feedback on whether the proposed Twirla NDA content will meet the FDA's requirements for submission. The FDA did not provide us with any guidance on
whether the results of the SECURE clinical trial and the contents of the planned, resubmitted NDA will be sufficient to obtain regulatory approval of Twirla. Based on our feedback from the FDA, we
filed our NDA resubmission, which was received by the FDA on June 26, 2017. On July 27, 2017, we announced that the FDA had acknowledged the resubmitted NDA for Twirla as a complete
response to the CRL, and provided a target Prescription Drug User Fee Act, or PDUFA, goal date of December 26, 2017. Our business plan assumes the FDA will complete its review of our NDA
resubmission by the target PDUFA goal date of December 26, 2017.
S-1
Table of Contents
We
intend to commercialize Twirla in the United States, if approved, through a direct sales force. Obstetricians and gynecologists, or ObGyns, contribute 43% of the U.S. contraception
prescription volume, and Nurse Practitioners and Physician Assistants, or NP/PAs, who are often affiliated with an ObGyn practice, contribute an additional 29% of the U.S. prescriptions. We anticipate
that a targeted sales force focused initially on ObGyns, NPs, PAs and primary care providers, who comprise the top prescribers of contraceptives, will be highly effective. We believe that we can
address this market with a specialty sales force of approximately 70 to 100 representatives. We also intend to augment our sales force through the use of digital marketing and other techniques
designed to market directly to patients. We will require additional capital for the commercial launch of Twirla, if approved.
In
addition to Twirla, we are developing a pipeline of other new transdermal contraceptive product candidates, including AG200-SP, which is a regimen designed to provide shorter, lighter
periods; AG200-ER, which is a regimen designed to allow a woman to extend the length of her cycle; and AG890, which is a progestin-only contraceptive patch intended for use by women who are unable or
unwilling to take estrogen. AG200-SP and AG200-ER are intended to be Twirla line extensions that would expand the use of Twirla beyond its initial, approved use. Substantially all of our resources are
currently dedicated to developing and seeking regulatory approval for Twirla. We will require additional capital for advancing the development of our other product candidates.
Our
current product candidate pipeline is summarized in the graphic below:
Corporate Information
Information concerning our business is contained in the documents that we file with the SEC as a reporting company under the Securities Exchange
Act of 1934, which are accessible at
www.sec.gov
, and on our website at
www.agiletherapeutics.com
. The
public can also obtain copies of these filings by
S-2
Table of Contents
visiting
the SEC's Public Reference Room at 100 F Street NE, Washington D.C. 20549, or by calling the SEC at 1-800-SEC-0330. The information contained on, or that can be accessed through, our
website is not a part of this prospectus. Investors should not rely on any such information in deciding whether to purchase our common stock. We have included our website address in this prospectus
solely as an inactive textual reference.
Our
principal executive offices are located at 101 Poor Farm Road, Princeton, New Jersey 08540, and our telephone number is (609) 683-1880.
Implications of Being an Emerging Growth Company
As a company with less than $1.07 billion in revenue during our last fiscal year, we qualify as an "emerging growth company" as defined
in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. For so long as we remain an emerging growth company, we are permitted and intend to rely on exemptions from specified disclosure
requirements that are applicable to other public companies that are not emerging growth companies. These exemptions include:
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being permitted to provide only two years of audited financial statements, in addition to any required unaudited interim financial statements,
with correspondingly reduced "Management's Discussion and Analysis of Financial Condition and Results of Operations" disclosure;
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not being required to comply with the auditor attestation requirements in the assessment of our internal control over financial reporting;
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not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory
audit firm rotation or a supplement to the auditor's report providing additional information about the audit and the financial statements;
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reduced disclosure obligations regarding executive compensation; and
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exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and shareholder approval of any golden
parachute payments not previously approved.
We
may take advantage of these provisions until December 31, 2019, or until such earlier time that we are no longer an emerging growth company. We would cease to be an emerging
growth company if we have more than $1.07 billion in annual revenues, have more than $700 million in market value of our capital stock held by non-affiliates or issue more than
$1 billion of non-convertible debt over a three-year period. We may choose to take advantage of some, but not all, of the available exemptions. We have taken advantage of some reduced reporting
burdens in this prospectus supplement, the accompanying prospectus and the documents incorporated by reference herein and therein. Accordingly, such information may be different than the information
you receive from other public companies in which you hold stock.
In
addition, the JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. This
provision allows an emerging growth company to delay the adoption of some accounting standards until those standards would otherwise apply to private companies. We have irrevocably elected not to
avail ourselves of this exemption from new or revised accounting standards and, therefore, we will be subject to the same new or revised accounting standards as other public companies that are not
emerging growth companies.
S-3
Table of Contents
THE OFFERING
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Common stock offered by us
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shares
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Total common stock to be outstanding after this offering
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shares, or shares if the underwriters exercise their
option to purchase additional shares in full.
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Option to purchase additional shares
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The underwriters have an option for a period of 30 days to purchase up to additional
shares of our common stock.
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Use of proceeds
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We intend to use the net proceeds of this offering to pursue regulatory approval for Twirla, to fund activities related to
commercial scale-up of our third party manufacturing operations and other activities related to the commercial launch of Twirla, if approved, and for working capital and other general corporate purposes. We may also use a portion of the net proceeds
for research and development activities related to our other product candidates, and to invest in or acquire businesses or technologies that we believe are complementary to our own, although we have no current plans, commitments or agreements with
respect to any acquisitions as of the date of this prospectus supplement. See "Use of Proceeds."
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Risk factors
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You should read the "Risk Factors" section of this prospectus supplement beginning on page S-6 and the documents
referred to therein for a discussion of factors to consider carefully before deciding to invest in shares of our common stock.
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NASDAQ Global Market symbol
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AGRX
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The
number of shares of our common stock to be outstanding after this offering is based on 28,806,398 shares of our common stock outstanding as of June 30, 2017, and
excludes:
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3,779,915 shares of common stock issuable upon the exercise of outstanding options to purchase common stock as of June 30, 2017 at a
weighted average exercise price of $5.83 per share;
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264,361 shares of common stock issuable upon vesting of restricted stock units as of June 30, 2017;
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260,000 shares of common stock issuable upon the vesting of performance restricted stock units as of June 30, 2017;
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283,141 shares of common stock reserved for future issuance under our 2014 Incentive Compensation Plan as of June 30, 2017; and
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242,779 shares of common stock issuable upon the exercise of outstanding warrants as of June 30, 2017 at a weighted average exercise
price of $5.92 per share.
Except
as otherwise indicated herein, all information in this prospectus supplement, including the number of shares of common stock that will be outstanding after this offering, assumes
the following:
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no exercise by the underwriters' of their option to purchase additional shares in this offering; and
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no exercise of outstanding options or warrants and no additional vesting of any outstanding restricted stock unit or performance restricted
stock unit, each after June 30, 2017.
S-4
Table of Contents
SUMMARY FINANCIAL DATA
The following summary financial data for the three years ended December 31, 2016 have been derived from our audited financial statements
incorporated by reference in this prospectus supplement. The following summary financial data for the six months ended June 30, 2016 and 2017 and as of June 30, 2017 have been derived
from our unaudited financial statements incorporated by reference in this prospectus supplement. Our unaudited financial statements have been prepared on the same basis as the audited financial
statements and, in the opinion of our management, include all adjustments, consisting of normal recurring adjustments and accruals, necessary for a fair statement of the information for the interim
periods. Our historical results for any prior periods are not necessarily indicative of results to be expected for a full year or for any future period. You should read this information together with
our financial statements and related notes incorporated by reference in this prospectus supplement and the information under "Management's Discussion and Analysis of Financial Condition and Results of
Operations" appearing in our most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, each as incorporated by reference herein.
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Year Ended December 31,
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Six Months Ended June 30,
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2014
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2015
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2016
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2016
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2017
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(unaudited)
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(in thousands, except share and per share data)
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Statement of Operations Data:
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Operating expenses:
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Research and development
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$
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13,365
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$
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25,622
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$
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20,929
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$
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10,505
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$
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8,519
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General and administrative
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|
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5,150
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7,467
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8,792
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4,316
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5,603
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Total operating expenses
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18,515
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33,089
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29,721
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14,821
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14,122
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Operating loss
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(18,515
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)
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(33,089
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)
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(29,721
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)
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(14,821
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)
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(14,122
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)
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Total other (expense) income
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(1,215
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)
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(3,218
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)
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(2,095
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)
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(915
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)
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|
(839
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)
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Loss before benefit from income taxes
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(19,730
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)
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(36,307
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)
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(31,816
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)
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(15,736
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)
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(14,961
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)
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Benefit from income taxes
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3,653
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|
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5,972
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3,075
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Net loss
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$
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(16,077
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)
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(30,335
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)
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(28,741
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)
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(15,736
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)
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(14,961
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)
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Net Loss per share:
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Basic and diluted
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$
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(1.41
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)
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$
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(1.38
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)
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$
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(1.02
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)
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$
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(0.57
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)
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$
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(0.52
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)
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Weight average shares:
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Basic and diluted
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|
|
11,394,971
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|
|
22,017,229
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|
|
28,273,331
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|
|
27,785,113
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|
|
28,785,827
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|
|
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|
|
|
|
|
|
|
|
|
|
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|
|
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|
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|
|
|
|
|
|
|
|
|
|
|
|
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|
|
As of June 30, 2017
|
|
|
|
Actual
|
|
As Adjusted(1)
|
|
|
|
(unaudited, in thousands)
|
|
Balance Sheet Data
|
|
|
|
|
|
|
|
Cash and cash equivalents
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|
$
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33,938
|
|
|
|
|
Total assets
|
|
|
47,250
|
|
|
|
|
Total current liabilities
|
|
|
10,223
|
|
|
10,223
|
|
Long term debt, less current portion
|
|
|
7,886
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|
|
7,886
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|
Total stockholders' equity
|
|
|
29,141
|
|
|
|
|
-
(1)
-
The
as-adjusted balance sheet data reflects the sale of shares of common stock offered by us in this offering at the public offering price of
$ per share, after deducting the underwriting discounts and commissions and estimated offering expenses payable by us.
S-5
Table of Contents
RISK FACTORS
An investment in our common stock involves a high degree of risk. Before deciding whether to invest in our common stock,
you should carefully consider the risks described below and those discussed under the Section captioned "Risk Factors" contained in our Quarterly Report on Form 10-Q for the quarter ended
June 30, 2017, which is incorporated by reference in this prospectus supplement and the accompanying prospectus, together with other information in this prospectus supplement, the accompanying
prospectus, the information and documents incorporated by reference herein and therein, and in any free writing prospectus that we have authorized for use in connection with this offering. If any of
these risks actually occurs, our business, financial condition, results of operations or cash flow could be seriously harmed. This could cause the trading price of our common stock to decline,
resulting in a loss of all or part of your investment.
Risks Related to This Offering
The price of our common stock may be volatile and fluctuate substantially, and you may not be able to resell
your shares at or above the public offering price.
The public offering price for our shares will be determined by negotiations between us and the representatives of the underwriters and may not
be indicative of prices that actually prevail in the trading market either before or after this offering. The market price for shares of our common stock may be subject to wide fluctuations in
response to many risk factors, including:
-
-
regulatory actions with respect to Twirla, including, for example, the FDA's failure to approve Twirla or the issuance of another complete
response letter in connection with our resubmitted NDA;
-
-
any adverse development or perceived adverse development with respect to the FDA's review of our resubmission of the NDA for Twirla or any
change to or inability by the FDA to meet the target PDUFA goal date of December 26, 2017;
-
-
our failure to commercialize Twirla, if approved, or develop and commercialize additional product candidates;
-
-
unanticipated efficacy, safety or tolerability concerns related to the use of Twirla;
-
-
inability to obtain adequate product supply of Twirla or inability to do so at acceptable prices;
-
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inability for Twirla to receive reimbursement from third party payors or other actions that limit a patient's access to Twirla;
-
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our lack of sufficient funds to commercially launch Twirla, if approved, and need to raise additional capital;
-
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changes in laws or regulations applicable to Twirla or any future product candidates, including but not limited to clinical trial requirements
for approvals;
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actual or anticipated fluctuations in our financial condition and operating results;
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actual or anticipated changes in our growth rate relative to our competitors;
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competition from existing products or new products that may emerge;
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announcements by us, our collaborators or our competitors of significant acquisitions, strategic partnerships, joint ventures, collaborations
or capital commitments;
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failure to meet or exceed financial estimates and projections of the investment community or that we provide to the public;
-
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issuance of new or updated research or reports by securities analysts;
S-6
Table of Contents
-
-
fluctuations in the valuation of companies perceived by investors to be comparable to us;
-
-
share price and volume fluctuations attributable to inconsistent trading volume levels of our shares;
-
-
additions or departures of key management or scientific personnel;
-
-
disputes or other developments related to proprietary rights, including patents, litigation matters and our ability to obtain patent protection
for our technologies;
-
-
announcement or expectation of additional debt or equity financing efforts;
-
-
sales of our common stock by us, our insiders or our other stockholders;
-
-
general economic, industry and market conditions; and
-
-
the other factors described in this "Risk Factors" section and in Part II, Item 1A "Risk Factors" of our Quarterly Report on
Form 10-Q filed with the SEC on July 28, 2017.
In
addition, the stock market has recently experienced significant volatility, particularly with respect to pharmaceutical and other life sciences company stocks. The volatility of such
stocks often does not relate to individual company performance. As we operate in a single industry, we are especially vulnerable to these factors to the extent that they affect our industry or our
product candidates or, to a lesser extent, our markets. In the past, securities class-action litigation has often been instituted against companies following periods of volatility in their stock
price. For example, following the drop in the price of our stock after we announced the top-line results of our Phase 3 SECURE clinical trial, on January 6, 2017, and January 20,
2017, two previously disclosed complaints captioned
Peng v. Agile Therapeutics, Inc., Alfred Altomari, and Elizabeth Garner
,
No. 17-cv-119 (D.N.J.), and
Lichtenthal v. Agile Therapeutics, Inc., Alfred Altomari, and Elizabeth Garner
, No. 17-cv-405
(D.N.J.), respectively, were filed in the United States District Court for the District of New Jersey on behalf of a putative class of investors who purchased shares of our common stock from
March 9, 2016, through January 3, 2017. The complaints alleged violations of the federal securities laws based on public statements made regarding our SECURE clinical trial and sought an
unspecified amount of damages to be determined at trial. We denied all allegations in the complaints. On May 15, 2017, the complaints were consolidated as
In re Agile
Therapeutics, Inc. Securities Litigation
, Master File No. 17-cv-119 (D.N.J.), and Hoyt W. Clark was appointed as class representative for the putative
class. On June 26, 2017, Mr. Clark agreed to dismiss the case voluntarily, without payment by us of any consideration and with each side bearing its own attorneys' fees and costs. The
presiding judge dismissed the consolidated action with prejudice as to all defendants on July 13, 2017. We also may face securities class-action litigation if we cannot obtain regulatory
approvals for, or if we otherwise fail to commercialize, our product candidates, including Twirla. Such litigation, if instituted against us, could cause us to incur substantial costs to defend such
claims and divert management's attention and resources, which could materially harm our financial condition and results of operations.
Management will have broad discretion as to the use of the proceeds from this offering, and we may not use
the proceeds effectively.
Our management will have broad discretion with respect to the use of proceeds of this offering, including for any of the purposes described in
the section of this prospectus supplement entitled "Use of Proceeds." You will be relying on the judgment of our management regarding the application of the proceeds of this offering. The results and
effectiveness of the use of proceeds are uncertain, and we could spend the proceeds in ways that you do not agree with or that do not improve our results of operations or enhance the value of our
common stock. Our failure to apply these funds effectively could have a material adverse effect on our business, delay the development of our product candidates and cause the price of our common stock
to decline.
S-7
Table of Contents
You will experience immediate and substantial dilution in the net tangible book value per share of the common
stock you purchase.
Since the public offering price for our common stock in this offering is substantially higher than the net tangible book value per share of our
common stock outstanding prior to this offering, you will suffer immediate and substantial dilution in the net tangible book value of the common stock you purchase in this offering. Based on the
public offering price of $ per share, if you purchase shares in this offering, you will suffer immediate dilution of
$ per share in the net tangible book value of the
common stock. If the underwriters exercise their option to purchase additional shares, you will experience additional dilution. See the section entitled "Dilution" below for a more detailed discussion
of the dilution you will incur if you purchase shares in this offering.
We will need to obtain additional financing to fund our operations and, if we are unable to obtain such
financing, we may be unable to complete the development and commercialization of our product candidates.
Our operations have consumed substantial amounts of cash since inception. From our inception to June 30, 2017, we have cumulative net
cash flows used by operating activities of $182.0 million. As of June 30, 2017, we had an accumulated deficit of approximately $208.4 million. We will need to obtain additional
financing to fund our future operations, including completing the development and commercialization of Twirla and our other product candidates. We believe that our existing cash and cash equivalents
will not be sufficient to fund our current and planned operations through the next 12 months, which raises substantial doubt about our ability to continue as a going concern. Substantial doubt
about our ability to continue as a going concern may create negative reactions to the price of our common stock and we may have a more difficult time obtaining financing in the future. Substantially
all of our resources are currently dedicated to developing and seeking regulatory approval for Twirla. We will require additional capital for the commercial launch of Twirla, if approved, as well as
advancing the development of our other product candidates. We will need to obtain additional financing to conduct additional trials for the approval of our product candidate, Twirla, if requested by
regulatory authorities, and to complete the development and commercialization of our other product candidates and any additional product candidates we might acquire. We expect to incur increased
expenses and increasing operating losses for the foreseeable future as we (i) seek the approval of our NDA for Twirla, which was supplemented with the results of our SECURE clinical trial and
accepted by the FDA with a target PDUFA goal date of December 26, 2017, to respond to the FDA's February 2013 CRL, (ii) complete the qualification and validation of our commercial
manufacturing process, initiate pre-launch commercial activities, and commercially launch Twirla, (iii) advance our other product candidates and (iv) expand our research and development
programs. Moreover, our fixed expenses such as rent, interest expense and other contractual commitments are substantial and are expected to increase in the future.
Our
future funding requirements will depend on many factors, including, but not limited to:
-
-
Time and cost necessary to obtain regulatory approvals that may be required by regulatory authorities;
-
-
Time and cost necessary to complete the qualification and validation of our manufacturing equipment and processes for Twirla;
-
-
Our ability to successfully commercialize our product candidates, if approved;
-
-
Our ability to have commercial products successfully manufactured consistent with FDA regulations;
-
-
Amount of sales and other revenues from product candidates that we may commercialize, if any, including the selling prices for such potential
products and the availability of adequate third-party coverage and reimbursement;
S-8
Table of Contents
-
-
Sales and marketing costs associated with commercializing our products, if approved, including the cost and timing of expanding our marketing
and sales capabilities;
-
-
Progress, timing, scope and costs of our clinical trials, including the ability to timely enroll subjects in our ongoing, planned and potential
future clinical trials;
-
-
Terms and timing of any potential future collaborations, licensing or other arrangements that we may establish;
-
-
Cash requirements of any future acquisitions or the development of other product candidates;
-
-
Costs of operating as a public company;
-
-
Time and cost necessary to respond to technological and market developments;
-
-
Costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; and
-
-
Costs associated with any potential business or product acquisitions, strategic collaborations, licensing agreements or other arrangements that
we may establish.
Until
we can generate a sufficient amount of revenue, we may finance future cash needs through public or private equity offerings, license agreements, debt financings, collaborations,
strategic alliances and marketing or distribution arrangements. Additional funds may not be available when we need them on terms that are acceptable to us, or at all. If adequate funds are not
available, we may be required to delay or reduce the scope of or eliminate one or more of our research or development programs or our commercialization efforts. We may seek to access the public or
private capital markets whenever conditions are favorable, even if we do not have an immediate need for additional capital at that time. In addition, if we raise additional funds through
collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams or
product candidates or to grant licenses on terms that may not be favorable to us.
Based
on our current business plan, we believe that our cash and cash equivalents as of June 30, 2017 will be sufficient to meet our operating requirements into the second quarter
of 2018. Our current business plan assumes the FDA will complete its review of our NDA resubmission by the target PDUFA goal date, December 26, 2017, initiation of pre-commercial activities and
initiation of validation of our commercial manufacturing process in coordination with the commercialization of Twirla, if approved. We anticipate that the net proceeds from this offering, together
with our existing cash and cash equivalents will be sufficient to enable us to fund our operating expenses and capital expenditure
requirements into the second quarter of 2018 and complete activities related to qualification and validation of our commercial manufacturing process and other activities related to the commercial
launch of Twirla, if approved. We cannot assure you that the FDA will approve Twirla, that the FDA's timeline for review will be within six months, or that we will timely complete the qualification
and validation of our commercial manufacturing process. We expect, however, that these funds will not be sufficient to enable us to complete all necessary development of our product candidates other
than Twirla, or commercially launch Twirla or our other current product candidates, if approved. Accordingly, we will be required to obtain further funding through other public or private offerings,
debt financing, collaboration or licensing arrangements or other sources. Adequate additional funding may not be available to us on acceptable terms, or at all. If we are unable to raise capital when
needed or on attractive terms, we would be forced to delay, reduce or eliminate our research and development programs or future commercialization efforts. Our forecast of the period of time through
which our financial resources will be adequate to support our operating requirements is a forward- looking statement and involves risks and uncertainties, and actual results could vary as a result of
a number of factors, including the factors discussed elsewhere in this "Risk Factors" section and in
S-9
Table of Contents
Part II,
Item 1A "Risk Factors" of our Quarterly Report on Form 10-Q filed with the SEC on July 28, 2017. We have based this estimate on a number of assumptions that may
prove to be wrong, and changing circumstances beyond our control may cause us to consume capital more rapidly than we currently anticipate. Our inability to obtain additional funding when we need it
could seriously harm our business.
A significant portion of our total outstanding shares is restricted from immediate resale but may be sold
into the market in the near future, which could cause the market price of our common stock to decline significantly, even if our business is doing well.
Sales of a substantial number of shares of our common stock in the public market could occur at any time. These sales, or the perception in the
market that the holders of a large number of shares of common stock intend to sell shares, could reduce the market price of our common stock. After this offering, we will
have shares
of common stock outstanding based on the 28,806,398 shares outstanding as of June 30, 2017 and the issuance and sale of shares of our common stock in this offering. Of these
shares, 3,726,048 shares are subject to a contractual lock-up with the underwriters for this offering for a period of 90 days following this offering. These shares can be sold, subject to any
applicable volume limitations under federal securities laws, after the earlier of the expiration of, or release from, the 90-day lock-up period. The balance of our outstanding shares of common stock
may be freely sold in the public market at any time. Moreover, certain holders of our common stock have rights, subject to conditions, to require us to file registration statements covering their
shares or to include their shares in registration statements that we may file for ourselves or other stockholders.
In
addition, as of June 30, 2017, there were 4,304,276 shares subject to outstanding grants under our equity incentive plans, all of which shares we have registered under the
Securities Act of 1933, as amended, which we refer to as the Securities Act, on a registration statement on Form S-8. These shares, once vested and issued upon exercise, will be able to be
freely sold in the public market, subject to volume limits applicable to affiliates and the lock-up agreements described above, to the extent applicable. Furthermore, as of June 30, 2017, there
were 242,779 shares subject to outstanding warrants. These shares will become eligible for sale in the public market to the extent such warrants are exercised and to the extent permitted by
Rule 144 under the Securities Act.
Our ability to use net operating loss and tax credit carryforwards and certain built-in losses to reduce
future tax payments may be limited by provisions of the Internal Revenue Code, and may be subject to further limitation as a result of this offering.
Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, or the Code, contain rules that limit the ability of a company
that undergoes an ownership change, which is generally any change in ownership of more than 50% of its stock over a three-year period, to utilize its net operating loss and tax credit carryforwards
and certain built-in losses recognized in years after the ownership change. These rules generally operate by focusing on ownership changes involving stockholders owning, directly or indirectly, 5% or
more of the stock of a company and any change in ownership arising from a new issuance of stock by the company. Generally, if an ownership change occurs, the yearly taxable income limitation on the
use of net operating loss and tax credit carryforwards and certain built-in losses is equal to the product of the applicable long-term tax exempt rate and the value of the company's stock immediately
before the ownership change. We may be unable to offset future taxable income, if any, with losses, or our tax liability with credits, before such losses and credits expire and therefore would incur
larger federal income tax liability.
In
addition, it is possible that the transactions relating to this offering, either on a standalone basis or when combined with future transactions, have caused or will cause us to
undergo one or more additional ownership changes. In that event, we generally would not be able to use our pre-change loss or credit carryovers or certain built-in losses prior to such ownership
change to offset future taxable income in excess of the annual limitations imposed by Sections 382 and 383. We have not completed a study to assess whether an ownership change has occurred, or
whether there have been multiple ownership changes since our inception.
S-10
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USE OF PROCEEDS
We estimate that the net proceeds from our issuance and sale of shares of common stock in this offering will be
approximately
$ million, or approximately $ million if the underwriters exercise their option to purchase
additional shares in full, based on the public offering price of
$ per share, after deducting the underwriting discounts and commissions and the estimated offering expenses payable by us.
We
intend to use the net proceeds of this offering to pursue regulatory approval for Twirla, to fund activities related to commercial scale-up of our third party manufacturing operations
and other activities related to the commercial launch of Twirla, if approved, and for working capital and other general corporate purposes. We may also use a portion of the net proceeds for research
and
development activities related to our other product candidates and to invest in or acquire businesses or technologies that we believe are complementary to our own, although we have no current plans,
commitments or agreements with respect to any acquisitions as of the date of this prospectus supplement. Pending these uses, we plan to invest these net proceeds in investment-grade, interest bearing
securities.
These
expected uses represent our intentions based upon our current plans and business conditions, which could change in the future as our plans and business conditions evolve. The
amounts and timing of our actual expenditures may vary significantly depending on numerous factors, including the progress of our development, the status of and results from clinical trials, and any
unforeseen cash needs. As a result, our management will have broad discretion in the application of the net proceeds from this offering, and investors will be relying on the judgment of our management
regarding the application of the net proceeds from this offering. The timing and amount of our actual expenditures will be based on many factors, including cash flows from operations and the
anticipated growth of our business.
We
anticipate that the net proceeds from this offering, together with our existing cash and cash equivalents will be sufficient to enable us to fund our operating expenses and capital
expenditure requirements into the second quarter of 2018. We believe that our available funds following this offering will allow us to complete activities related to commercial scale-up of our third
party manufacturing operations and other activities related to the commercial launch of Twirla, if approved. However, depending on the length of time the FDA takes to review our submission, these
funds may not be sufficient to enable us to complete our regulatory approval process for Twirla and, in that case, we do not expect that these funds will be sufficient to enable us to commercially
launch Twirla. We have based these estimates on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect. We have no external sources of
funds other than our loan and security agreement with Hercules Technology Growth Capital, Inc. We expect that we will need to obtain additional funding in order to continue to operate our
business beyond the commercial launch of Twirla, if approved, including continued commercialization activities for Twirla.
S-11
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CAPITALIZATION
The following table sets forth our cash and cash equivalents and our capitalization as of June 30,
2017:
-
-
on an actual basis; and
-
-
on an as adjusted basis to reflect our issuance and sale of shares of common stock in this offering at the
public offering
price of $ per share, after deducting the underwriting discounts and commissions and estimated offering expenses payable by us.
You
should read this table together with our financial statements and the related notes incorporated by reference in this prospectus supplement and the sections entitled "Management's
Discussion and Analysis of Financial Condition and Results of Operations" included in our most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, each as incorporated
by reference herein.
|
|
|
|
|
|
|
|
|
|
As of June 30, 2017,
|
|
|
|
Actual
|
|
As
Adjusted(1)
|
|
|
|
(in thousands, except
share and per share
data)
|
|
|
|
(unaudited)
|
|
Stockholders' equity:
|
|
|
|
|
|
|
|
Preferred stock, $0.0001 par value; 10,000,000 shares authorized, no shares issued and outstanding, actual or as adjusted
|
|
|
|
|
|
|
|
Common stock, $0.0001 par value; 150,000,000 shares authorized, 28,806,398 shares issued and outstanding, actual
or shares issued and outstanding as adjusted
|
|
|
3
|
|
|
|
|
Additional paid-in capital
|
|
|
237,567
|
|
|
|
|
Accumulated deficit
|
|
|
(208,429
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders' equity
|
|
|
29,141
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total capitalization
|
|
$
|
29,141
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
-
(1)
-
The
as adjusted balance sheet data reflects the sale of shares of common stock offered by us in this offering at the public offering price of
$ per share, after deducting the underwriting discounts and commissions and estimated offering expenses payable by us.
The
foregoing table and calculations are based on 28,806,398 shares of our common stock outstanding as of June 30, 2017, and exclude:
-
-
3,779,915 shares of common stock issuable upon the exercise of outstanding options to purchase common stock as of June 30, 2017 at a
weighted average exercise price of $5.83 per share;
-
-
264,361 shares of common stock issuable upon vesting of restricted stock units as of June 30, 2017;
-
-
260,000 shares of common stock issuable upon the vesting of performance restricted stock units as of June 30, 2017;
-
-
283,141 shares of common stock reserved for future issuance under our 2014 Incentive Compensation Plan as of June 30, 2017; and
-
-
242,779 shares of common stock issuable upon the exercise of outstanding warrants as of June 30, 2017 at a weighted average exercise
price of $5.92 per share.
S-12
Table of Contents
DILUTION
If you invest in our common stock, your interest will be diluted immediately to the extent of the difference between the public offering price
per share you will pay in this offering and the as adjusted net tangible book value per share of our common stock after this offering. Net tangible book value per share represents our total tangible
assets less total liabilities, divided by the number of shares of our common stock outstanding.
As
of June 30, 2017, our net tangible book value was $29.1 million, or $1.01 per share of common stock. After giving effect to our issuance and sale of of
shares of common stock in this offering at the public offering price of $ per share, after deducting the underwriting discounts and commissions and the estimated offering expenses
payable by us, the as adjusted net tangible book value as of June 30, 2017 would have been $ , or $ per
share. This represents an immediate increase in as adjusted
net tangible book value to existing stockholders of $ per share and an immediate dilution to new investors purchasing common stock in this offering of
$ per share.
The
following table illustrates this per share dilution to the new investors purchasing shares of common stock in this offering:
|
|
|
|
|
|
|
|
Public offering price per share
|
|
|
|
|
$
|
|
|
Net tangible book value per share at June 30, 2017
|
|
$
|
1.01
|
|
|
|
|
Increase in net tangible book value per share attributable to new investors purchasing shares in this offering
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As adjusted net tangible book value per share after this offering
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dilution per share to new investors in this offering
|
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
If
the underwriters exercise their option to purchase additional shares in full, at the public offering price of $ per share, the as adjusted net tangible book value will
increase to $ per share, representing
an immediate increase in net tangible book value to existing stockholders of $ per share and an immediate dilution in net tangible book value of
$ per share to new
investors.
The
foregoing table and calculations are based on 28,806,398 shares of our common stock outstanding as of June 30, 2017, and exclude:
-
-
3,779,915 shares of common stock issuable upon the exercise of outstanding options to purchase common stock as of June 30, 2017 at a
weighted average exercise price of $5.83 per share;
-
-
264,361 shares of common stock issuable upon vesting of restricted stock units as of June 30, 2017;
-
-
260,000 shares of common stock issuable upon the vesting of performance restricted stock units as of June 30, 2017;
-
-
283,141 shares of common stock reserved for future issuance under our 2014 Incentive Compensation Plan as of June 30, 2017; and
-
-
242,779 shares of common stock issuable upon the exercise of outstanding warrants as of June 30, 2017 at a weighted average exercise
price of $5.92 per share.
S-13
Table of Contents
MATERIAL U.S. FEDERAL INCOME TAX CONSEQUENCES TO NON-U.S. HOLDERS
The following is a general discussion of the material U.S. federal income tax consequences of the acquisition, ownership and disposition of our
common stock by "Non-U.S. Holders" (as defined below). This discussion is a summary for general information purposes only and does not consider all aspects of U.S. federal income taxation that may be
relevant to particular Non-U.S. Holders in light of their individual circumstances or to certain types of Non-U.S. Holders subject to special tax rules under the Internal Revenue Code of 1986, as
amended, or the Code, including partnerships or other pass-through entities for U.S. federal income tax purposes, banks, financial institutions or other financial services entities, broker-dealers,
insurance companies, tax-exempt organizations, regulated investment companies, real estate investment trusts, controlled foreign corporations, passive foreign investment companies, corporations that
accumulate earnings to avoid U.S. federal income tax, persons who use or are required to use mark-to-market accounting, persons that hold our shares as part of a "straddle," a "hedge" or a "conversion
transaction," persons for whom our stock constitutes "qualified small business stock" within the meaning of Section 1202 of the Code, certain former citizens or permanent residents of the U.S.,
or investors in pass-through entities. In addition, this summary does not address the effects of any applicable gift or estate tax, and this summary does not address the potential application of the
alternative minimum tax, Medicare contribution tax or any tax considerations that may apply to Non-U.S. Holders of our common stock under state, local or non-U.S. tax laws or any other U.S. federal
tax laws. This discussion also does not take into account or address changes to U.S. tax law that may result from tax reforms that may be enacted in 2017 or thereafter.
This
summary is based on the Code, and applicable Treasury Regulations, rulings, administrative pronouncements and decisions as of the date of this registration statement, all of which
are subject to change or differing interpretations at any time with possible retroactive effect. We have not sought, and will not seek, any ruling from the Internal Revenue Service, or the IRS, with
respect to the tax consequences discussed herein, and there can be no assurance that the IRS will not take a position contrary to the tax consequences discussed below or that any position taken by the
IRS would not be sustained. This discussion assumes that a Non-U.S. Holder will hold our common stock as a "capital asset" within the meaning of Section 1221 of the Code (generally, property
held for investment).
The
following discussion is for general information only and is not tax advice for any Non-U.S. Holder under its particular circumstances. Persons considering the purchase of our common
stock pursuant to this offering should consult their tax advisors concerning the U.S. federal income, estate and gift tax consequences of acquiring, owning and disposing of our common stock in light
of their particular situations as well as any consequences arising under the laws of any other taxing jurisdiction, including any state, local and non-U.S. tax consequences and the possible
application of tax treaties that might change the general provisions discussed below.
For
purposes of this discussion, the term "Non-U.S. Holder" means a beneficial owner of our shares that is not a partnership (or entity or arrangement treated as a partnership for U.S.
federal income tax purposes) or an entity that is treated as a disregarded entity for U.S. federal income tax purposes and is not:
-
-
an individual who is a citizen or resident of the U.S.;
-
-
a corporation (or other entity treated as a corporation for U.S. federal income tax purposes) created or organized in the U.S. or under the
laws of the U.S. or of any state thereof or the District of Columbia;
-
-
an estate, the income of which is subject to U.S. federal income tax regardless of its source; or
-
-
a trust if (1) a U.S. court can exercise primary supervision over the trust's administration and one or more U.S. persons have the
authority to control all of the trust's substantial decisions or
S-14
Table of Contents
If
a partnership (or entity or arrangement treated as a partnership for U.S. federal income tax purposes) or an entity that is treated as a disregarded entity for U.S. federal income tax
purposes (regardless of its place of organization or formation) is a beneficial owner of our common stock, the tax treatment of a partner in the partnership or the owner of the disregarded entity will
generally depend upon the status of the partner or the owner of the disregarded entity and the activities of the partnership or the disregarded entity. If you are a partner of a partnership holding
our common stock or the owner of a disregarded entity holding our common stock, you should consult your tax advisor regarding the tax consequences of the purchase, ownership, and disposition of our
common stock.
PROSPECTIVE
INVESTORS SHOULD CONSULT THEIR TAX ADVISORS REGARDING THE PARTICULAR U.S. FEDERAL INCOME TAX CONSEQUENCES TO THEM OF ACQUIRING, OWNING AND DISPOSING OF OUR COMMON STOCK, AS
WELL AS ANY TAX CONSEQUENCES ARISING UNDER ANY STATE, LOCAL OR FOREIGN TAX LAWS AND ANY OTHER U.S. FEDERAL TAX LAWS.
Distributions on Our Common Stock
In general, distributions, if any, paid to a Non-U.S. Holder (to the extent paid out of our current or accumulated earnings and profits, as
determined under U.S. federal income tax principles) will constitute dividends and be subject to U.S. withholding tax at a rate equal to 30% of the gross amount of the dividend, or a lower rate
prescribed by an applicable income tax treaty, unless the dividends are effectively connected with a trade or business carried on by the Non-U.S. Holder within the U.S. Any distribution not
constituting a dividend (because such distribution exceeds our current and accumulated earnings and profits) will be treated first as reducing the Non-U.S. Holder's basis in its shares of common
stock, but not below zero, and to the extent it exceeds the Non-U.S. Holder's basis, as capital gain and will be treated as described below under "Gain on Sale, Exchange or Other Disposition of Our
Common Stock".
A
Non-U.S. Holder who claims the benefit of an applicable income tax treaty generally will be required to satisfy certain certification and other requirements prior to the distribution
date. Non-U.S. Holders must generally provide the withholding agent with a properly executed IRS Form W-8BEN, Form W-8BEN-E or other appropriate form claiming an exemption from or
reduction in withholding under an applicable income tax treaty. This certification must be updated periodically. If a Non-U.S. Holder holds our common stock through a financial institution or other
agent acting on the Non-U.S. Holder's behalf, the Non-U.S. Holder will be required to provide appropriate documentation to the agent, who then will be required to provide certification to us or our
paying agent, either directly or through other intermediaries. If tax is withheld in an amount in excess of the amount applicable under an income tax treaty, a refund of the excess amount may
generally be obtained by timely filing an appropriate claim for refund with the IRS. Non-U.S. Holders should consult their tax advisors regarding their entitlement to benefits under an applicable
income tax treaty.
Dividends
that are effectively connected with a Non-U.S. Holder's conduct of a U.S. trade or business (and, if required by an applicable income tax treaty, attributable to a U.S.
permanent establishment or fixed base of the Non-U.S. Holder) generally will not be subject to U.S. withholding tax if the Non-U.S. Holder provides the withholding agent with the required forms,
including IRS Form W-8ECI, but instead generally will be subject to U.S. federal income tax on a net income basis at the regular graduated rates in the same manner as if the Non-U.S. Holder
were a resident of the U.S. A corporate Non-U.S. Holder that receives effectively connected dividends may also be subject to an additional branch profits tax at a rate of 30% (or a lower rate
prescribed by an applicable income tax
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treaty)
of its effectively connected earnings and profits for the taxable year, as adjusted for certain items.
Gain on Sale, Exchange or Other Disposition of Our Common Stock
In general, a Non-U.S. holder will not be subject to any U.S. federal income tax or withholding tax on any gain realized upon such holder's
sale, exchange or other disposition of shares of our common stock unless:
(i) the
gain is effectively connected with a trade or business carried on by the Non-U.S. Holder within the U.S. (and, if required by an applicable income tax treaty,
attributable to a U.S. permanent establishment or fixed base of the Non-U.S. Holder);
(ii) the
Non-U.S. Holder is an individual who is present in the U.S. for 183 days or more in the taxable year of disposition and certain other conditions are met; or
(iii) we
are or have been a "United States real property holding corporation" for U.S. federal income tax purposes at any time during the shorter of the five-year period
ending on the date of disposition or the period that the Non-U.S. Holder held the common stock, and, in the case where shares of our common stock are regularly traded on an established securities
market, the Non-U.S. Holder owns, or is treated as owning, more than five percent of our common stock at any time during the foregoing period.
Net
gain realized by a Non-U.S. Holder described in clause (i) above generally will be subject to U.S. federal income tax in the same manner as if the Non-U.S. Holder were a U.S.
person. Any gains of a corporate Non-U.S. Holder described in clause (i) above may also be subject to an additional branch profits tax at a 30% rate, or such lower rate as may be specified by
an applicable income tax treaty.
Gain
realized by an individual Non-U.S. Holder described in clause (ii) above will be subject to a flat 30% (or such lower rate specified by an applicable income tax treaty) tax,
which gain may be offset by certain U.S. source capital losses, even though the individual is not considered a resident of the U.S., provided that the Non-U.S. Holder has timely filed U.S. federal
income tax returns with respect to such losses.
For
purposes of clause (iii) above, a corporation is a "United States real property holding corporation" if the fair market value of its U.S. real property interests equals or
exceeds 50% of the sum of the fair market value of its worldwide real property interests plus its other assets used or held for use in a trade or business. We believe that we are not, and we do not
anticipate that we will become, a United States real property holding corporation. However, because the determination of whether we are a United States real property holding corporation depends on the
fair market value of our U.S. real property interests relative to the fair market value of our other business assets, there can be no assurance that we will not become a United States real property
holding corporation in the future. If we become a United States real property holding corporation, as long as our common stock is regularly traded on an established securities market, our common stock
will be treated as a U.S. real property interest only with respect to a Non-U.S. Holder that actually or constructively held more than 5% of our common stock at any time during the shorter of the two
periods described in clause (iii), above. If gain on the sale or other taxable disposition of our common stock were subject to taxation under clause (iii) above, the Non-U.S. Holder
would be subject to regular U.S. federal income tax with respect to such gain in generally the same manner as a U.S. person.
Information Reporting and Backup Withholding
Generally, we must report annually to the IRS and to each Non-U.S. Holder the amount of dividends paid, the name and address of the recipient,
and the amount, if any, of tax withheld. These
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information
reporting requirements apply even if withholding was not required because the dividends were effectively connected with the Non-U.S. Holder's conduct of a trade or business within the U.S.
or withholding was reduced by an applicable income tax treaty. Under applicable income tax treaties or other agreements, the IRS may make its reports available to the tax authorities in the Non-U.S.
Holder's country of residence.
Dividends
paid to a Non-U.S. Holder that is not an exempt recipient generally will be subject to backup withholding, currently at a rate of 28%, unless the Non-U.S. Holder certifies to
the withholding agent as to its foreign status, which certification may generally be made on IRS Form W-8BEN, Form W-8BEN-E or other appropriate version of IRS Form W-8.
Notwithstanding the foregoing, backup withholding may apply if either we or our paying agent has actual knowledge, or reason to know, that the holder is a U.S. person that is not an exempt recipient.
Proceeds
from the sale or other disposition of common stock by a Non-U.S. Holder effected by or through a U.S. office of a broker will generally be subject to information reporting and
backup withholding, currently at a rate of 28%, unless the Non-U.S. Holder certifies to the withholding agent under penalties of perjury as to, among other things, its name, address and status as a
Non-U.S. Holder or otherwise establishes an exemption. Payment of disposition proceeds effected outside the U.S. by or through a non-U.S. office of a non-U.S. broker generally will not be subject to
information reporting or backup withholding if the payment is not received in the U.S. Information reporting, but generally not backup withholding (provided the broker does not have actual knowledge
or reason to know that the holder is a U.S. person that is not an exempt recipient), will apply to such a payment if the broker has certain connections with the U.S. unless the broker has documentary
evidence in its records that the beneficial owner thereof is a Non-U.S. Holder and specified conditions are met or an exemption is otherwise established.
Backup
withholding is not an additional tax. Any amount withheld under the backup withholding rules from a payment to a Non-U.S. Holder that results in an overpayment of taxes generally
will be refunded, or credited against the holder's U.S. federal income tax liability, if any, provided that the required information is timely furnished to the IRS.
Foreign Accounts
A U.S. federal withholding tax of 30% may apply to dividends and the gross proceeds of a disposition of our common stock paid to a "foreign
financial institution" (as specially defined under applicable rules) unless such institution enters into an agreement with the U.S.
government to withhold on certain payments and to collect and provide to the U.S. tax authorities substantial information regarding certain U.S. account holders of such institution (which includes
certain equity and debt holders of such institution, as well as certain account holders that are foreign entities with U.S. owners). This U.S. federal withholding tax of 30% will also apply to
payments of dividends and the gross proceeds of a disposition of our common stock paid to a "non-financial foreign entity" (as specially defined under applicable rules) unless such entity either
certifies it does not have any substantial U.S. owners or provides the withholding agent with a certification identifying substantial direct and indirect U.S. owners of the entity. The withholding tax
described above will not apply if the foreign financial institution or non-financial foreign entity otherwise qualifies for an exemption from the rules. Under certain circumstances, a Non-U.S. Holder
might be eligible for refunds or credits of such taxes. The U.S. has entered into agreements with certain countries that modify these general rules for entities located in those countries. Prospective
investors are encouraged to consult with their tax advisors regarding the possible implications of these withholding provisions on their investment in our common stock.
The
withholding provisions described above currently apply to payments of dividends and will generally apply to payments of gross proceeds from a sale or other disposition of our common
stock on or after January 1, 2019.
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UNDERWRITING
Under the terms and subject to the conditions to be set forth in an underwriting agreement, dated as
of , 2017, by and between us
and William Blair & Company, L.L.C. and RBC Capital Markets, LLC, acting as representatives for the underwriters named below, we have agreed to sell to the underwriters, and the
underwriters have agreed to purchase from us, the following respective number of shares of common stock:
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Name
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Number of
Shares
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William Blair & Company, L.L.C.
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RBC Capital Markets, LLC
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Cantor Fitzgerald & Co.
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Total
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|
|
|
|
|
|
|
|
The
underwriting agreement provides that the obligations of the underwriters are subject to certain conditions precedent, such as the receipt by the underwriters of officers'
certificates and legal opinions. The underwriting agreement provides that the underwriters will purchase all of the shares if any of them are purchased. We have agreed to indemnify the underwriters
and certain of their controlling persons against certain liabilities, including liabilities under the Securities Act, and to contribute to payments that the underwriters may be required to make in
respect of those liabilities.
The
underwriters are offering the shares subject to their acceptance of the shares from us and subject to prior sale. The underwriters reserve the right to withdraw, cancel or modify
offers to the public and to reject orders in whole or in part.
Option to Purchase Additional Shares
We have granted the underwriters an option, exercisable no later than 30 calendar days after the date of the underwriting agreement, to purchase
up to an aggregate of additional shares at the public offering price, less the underwriting discounts and commissions set forth on the cover page of this prospectus supplement and as
indicated below. We will be obligated to sell these shares to the underwriters to the extent the option is exercised.
Discount and Expenses
The underwriters have advised us that they propose to offer the shares of common stock directly to the public at the offering price set forth on
the cover page of this prospectus supplement and to certain dealers at that price less a concession not in excess of $ per share. After this offering, the public offering price and the
concession to dealers may be reduced by the underwriters. No such reduction will change the amount of proceeds to be received by us as set forth on the cover page of this prospectus supplement.
The
following table shows the per share and total underwriting discount that we will pay to the underwriters and the proceeds we will receive before expenses. These amounts are shown
assuming both no exercise and full exercise of the underwriters' option to purchase additional shares.
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PER
SHARE
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TOTAL
WITHOUT
EXERCISE
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TOTAL
WITH
EXERCISE
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Public offering price
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$
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$
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$
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|
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Underwriting discounts and commissions
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$
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$
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$
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Proceeds to us, before expenses
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$
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$
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$
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We
have also agreed to reimburse the underwriters for certain of their expenses incurred in connection with the review by the Financial Industry Regulatory Authority, Inc. of the terms
of this offering, in an amount not to exceed $35,000. We estimate the total offering expenses of this offering that will be payable by us, excluding the underwriting discounts and commissions, will be
approximately $500,000, which includes legal costs and various other fees. Additionally, we have agreed to reimburse the underwriters for certain expenses in an amount not to exceed $50,000.
No Sale of Similar Securities
We, our officers, directors and certain holders of our outstanding capital stock have agreed, subject to specified exceptions, not to directly
or indirectly, for a period of 90 days after
the date of this prospectus, without the prior written consent of the representatives:
-
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sell, offer to sell, contract or grant any option to sell, effect any short sale, grant any option, right or warrant to purchase, pledge,
transfer, establish an open "put equivalent position" within the meaning of Rule 16a-l(h) under the Exchange Act, lend or otherwise dispose of, or enter into any swap or other arrangement that
transfers, in whole or in part, the economic consequences of ownership of, any shares of common stock, options or warrants to acquire shares of common stock, or securities exchangeable or exercisable
for or convertible into shares of common stock currently or hereafter owned either of record or beneficially, or publicly announce any intention to do any of the foregoing, or
-
-
make any demand for, or exercise any right to, registration with the SEC of any shares of common stock, options or warrants to acquire shares
of common stock, or securities exchangeable or exercisable for or convertible into shares of common stock.
The
lock-up restrictions terminate after the close of trading of the common stock on and including the 90th day after the date of this prospectus. The representatives may, in
their sole discretion and at any time or from time to time before the termination of the 90-day period release all or any portion of the securities subject to lock-up agreements. These restrictions
apply to shares of our common stock purchased in this offering by certain holders for a period of 90 days after the date of this prospectus.
The
restrictions described above do not apply to:
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awards by us of options to purchase shares of our common stock pursuant to employee benefit plans;
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any issuance by us of shares of our common stock or securities convertible or exercisable or exchangeable for shares of our common stock
pursuant to the exercise or conversion of warrants, options, or other convertible or exchangeable securities, in each case outstanding as of the date of this prospectus;
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the issuance of shares of our common stock to one or more counterparties in connection with the consummation, by us, of a strategic
partnership, joint venture, collaboration or acquisition or license of any business products or technology, provided that the aggregate number of shares of our common stock issuable will not exceed
one percent (1%) of our outstanding shares of common stock immediately following the date the shares offered by this prospectus are delivered to the underwriters;
-
-
transactions relating to shares of our common stock or other securities acquired in open market transactions after the completion of this
offering;
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transfers of shares of our common stock, or any security convertible into, exercisable or exchangeable for our common stock, as a bona fide
gift, by will or intestacy or to a family member or trust, partnership, limited liability company or other entity for the direct benefit of the lock-up signatory or a family member;
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transfers of shares of our common stock, or any security convertible into, exercisable or exchangeable for our common stock to a charity or
educational institution;
-
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transfers of shares of our common stock, or any security convertible into, exercisable or exchangeable for our common stock, to any
shareholder, partner or member of, or owner of similar equity interests in, a holder, if the holder controls, directly or indirectly, any corporation, partnership, limited liability company or other
business entity;
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transfers of shares of our common stock, or any security convertible into, exercisable or exchangeable for our common stock, to affiliates of
or any investment fund or other entity controlled or managed by a holder;
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transfers to us for the purpose of satisfying tax withholding obligations upon the vesting of other equity incentive awards granted under any
existing stock incentive plan or stock purchase plan described in this prospectus;
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transfers to a nominee or custodian of a person or entity to whom a disposition or transfer would be permissible;
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transfers of shares of our common stock, or any securities convertible into, exercisable or exchangeable for our common stock, pursuant to an
order of a court or regulatory agency; or
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transfers, sales, tenders or other dispositions of shares of our common stock, or any securities convertible into, exercisable or exchangeable
for our common stock, occurring after the consummation of this offering, pursuant to a bona fide third-party tender offer for our securities that would result in the disposition of not less than a
majority of the outstanding shares of our voting securities, or pursuant any other transaction, including a merger, consolidation or other business combination, resulting in a disposition of not less
than a majority of the outstanding shares of our voting securities (including entering into any lock-up, voting or similar agreement to transfer, sell, tender or otherwise dispose of any shares of our
common stock, or to vote any shares of our common stock in favor of such a transaction), provided that in the event that such tender offer or other transaction is not completed, our common stock and
any security convertible into or exchangeable for our common stock that are subject to the lock-up agreement shall remain subject to the same restrictions,
provided,
however, that in the case of any transfer or distribution pursuant to the first, second, third, fifth, sixth, seventh, eighth, ninth, tenth and eleventh clauses above, each donee,
distributee recipient or transferee shall sign and deliver a lock-up agreement substantially in the form of the lock-up agreements described above; and in the case of any transfer or distribution
pursuant to the fifth, sixth,
seventh, eighth, ninth and tenth clauses above, (i) such transfer or distribution shall not involve a disposition for value and (ii) no filing under Section 16(a) of the Exchange
Act, reporting a reduction in beneficial ownership of shares of our common stock, shall be required or shall be voluntarily made during the restricted period.
There
are no existing agreements between the underwriters and any of our stockholders who will execute a lock-up agreement, providing consent to the sale of shares prior to the
expiration of the lock-up period.
NASDAQ Global Market Listing
Our common stock is listed for trading on The NASDAQ Global Market under the symbol "AGRX".
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Short Sales, Stabilizing Transactions, and Penalty Bids
Until the distribution of the common stock is completed, SEC rules may limit the underwriters from bidding for and purchasing our common stock.
In
connection with this offering, the underwriters may engage in transactions that stabilize, maintain or otherwise make short sales of our common stock and may purchase shares of our
common stock in the open market to cover positions created by short sales. Short sales involve the sale by the underwriters of a greater number of shares than they are required to purchase in this
offering. The underwriters may close out any short position by purchasing shares of our common stock in the open market or exercising their option to purchase additional shares. A short position is
more likely to be created if the underwriters are concerned that there may be downward pressure on the price of our common stock in the open market after pricing that could adversely affect investors
who purchase in this offering. The underwriters may also engage in "stabilizing bids," which are bids for or the purchase of shares of our
common stock on behalf of the underwriters in the open market prior to the completion of this offering for the purpose of fixing or maintaining the price of our common stock.
The
underwriters' purchases to cover short sales, as well as other purchases by the underwriters for their own account, and stabilizing bids may have the effect of raising or maintaining
the market price of our common stock or preventing or retarding a decline in the market price of our common stock. As a result, the price of our common stock may be higher than the price that might
otherwise exist in the open market.
In
connection with this offering, the underwriters may also engage in passive market making transactions in our common stock on the NASDAQ Global Market in accordance with
Rule 103 of Regulation M during a period before the commencement of offers or sales of shares of our common stock in this offering and extending through the completion of distribution. A
passive market maker must display its bid at a price not in excess of the highest independent bid of that security. However, if all independent bids are lowered below the passive market maker's bid,
that bid must then be lowered when specified purchase limits are exceeded.
Neither
we, nor the underwriters, make any representation or prediction as to the direction or magnitude of any effect that the transactions described above may have on the price of our
common stock. In addition, neither we nor the underwriters makes any representation that the underwriters will engage in these transactions or that any transaction, if commenced, will not be
discontinued without notice.
Affiliations
Certain of the underwriters or their affiliates may in the future provide investment banking, lending, financial advisory and other related
services to us and our affiliates for which they may receive customary fees and commissions.
Selling Restrictions
Canada
The shares of our common stock may be sold only to purchasers purchasing, or deemed to be purchasing, as principal that are accredited
investors, as defined in National Instrument 45-106
Prospectus Exemptions
or subsection 73.3(1) of the
Securities
Act
(Ontario), and are permitted clients, as defined in National Instrument 31-103
Registration Requirements, Exemptions and Ongoing Registrant
Obligations
. Any resale of the shares of our common stock must be made in accordance with an exemption from, or in a transaction not subject to, the prospectus requirements of
applicable securities laws.
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Securities
legislation in certain provinces or territories of Canada may provide a purchaser with remedies for rescission or damages if this prospectus (including any amendment thereto)
contains a misrepresentation, provided that the remedies for rescission or damages are exercised by the purchaser within the time limit prescribed by the securities legislation of the purchaser's
province or territory. The purchaser should refer to any applicable provisions of the securities legislation of the purchaser's province or territory for particulars of these rights or consult with a
legal advisor.
Pursuant
to section 3A.3 (or, in the case of securities issued or guaranteed by the government of a non-Canadian jurisdiction, section 3A.4) of National
Instrument 33-105
Underwriting Conflicts
(NI 33-105), the underwriters are not required to comply with the disclosure requirements of
NI 33-105 regarding underwriter conflicts of interest in connection with this offering.
European Economic Area
In relation to each Member State of the European Economic Area (each, a "Relevant Member State"), no offer of shares may be made to the public
in that Relevant Member State other than:
(a) to
any legal entity which is a qualified investor as defined in the Prospectus Directive;
(b) to
fewer than 100 or, if the Relevant Member State has implemented the relevant provision of the 2010 PD Amending Directive, 150, natural or legal persons (other than
qualified investors as defined in the Prospectus Directive), as permitted under the Prospectus Directive, subject to obtaining the prior consent of the representatives; or
(c) in
any other circumstances falling within Article 3(2) of the Prospectus Directive,
provided
that no such offer of shares shall require the Company or the representatives to publish a prospectus pursuant to Article 3 of the Prospectus Directive or supplement a prospectus
pursuant to Article 16 of the Prospectus Directive.
Each
person in a Relevant Member State who initially acquires any shares or to whom any offer is made will be deemed to have represented, acknowledged and agreed that it is a "qualified
investor" within the meaning of the law in that Relevant Member State implementing Article 2(1)(e) of the Prospectus Directive. In the case of any shares being offered to a financial
intermediary as that term is used in Article 3(2) of the Prospectus Directive, each such financial intermediary will be deemed to have represented, acknowledged and agreed that the shares
acquired by it in the offer have not been acquired on a non-discretionary basis on behalf of, nor have they been acquired with a view to their offer or resale to, persons in circumstances which may
give rise to an offer of any shares to the public other than their offer or resale in a Relevant Member State to qualified investors as so defined or in circumstances in which the prior consent of the
representatives has been obtained to each such proposed offer or resale.
The
Company, the representatives and their affiliates will rely upon the truth and accuracy of the foregoing representations, acknowledgements and agreements. This prospectus has been
prepared on the basis that any offer of shares in any Relevant Member State will be made pursuant to an exemption under the Prospectus Directive from the requirement to publish a prospectus for offers
of shares. Accordingly any person making or intending to make an offer in that Relevant Member State of shares which are the subject of the offering contemplated in this prospectus may only do so in
circumstances in which no obligation arises for the Company or any of the underwriters to publish a prospectus pursuant to Article 3 of the Prospectus Directive in relation to such offer.
Neither the Company nor the underwriters have authorized, nor do they authorize, the making of any offer of shares in circumstances in which an obligation arises for the Company or the underwriters to
publish a prospectus for such offer.
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For
the purpose of the above provisions, the expression "an offer to the public" in relation to any shares in any Relevant Member State means the communication in any form and by any
means of sufficient information on the terms of the offer and the shares to be offered so as to enable an investor to decide to purchase or subscribe the shares, as the same may be varied in the
Relevant Member State by any measure implementing the Prospectus Directive in the Relevant Member State and the expression "Prospectus Directive" means Directive 2003/71/EC (including the 2010 PD
Amending Directive, to the extent implemented in the Relevant Member States) and includes any relevant implementing measure in the Relevant Member State and the expression "2010 PD Amending Directive"
means Directive 2010/73/EU.
Hong Kong
The shares may not be offered or sold by means of any document other than (i) in circumstances which do not constitute an offer to the
public within the meaning of the Companies Ordinance (Cap.32, Laws of Hong Kong), or (ii) to "professional investors" within the meaning of the Securities and Futures Ordinance (Cap.571, Laws
of Hong Kong) and any rules made thereunder, or (iii) in other circumstances which do not result in the document being a "prospectus" within the meaning of the Companies Ordinance (Cap.32, Laws
of Hong Kong), and no advertisement, invitation or document relating to the shares may be issued or may be in the possession of any person for the purpose of issue (in each case whether in Hong Kong
or elsewhere), which is directed at, or the contents of which are likely to be accessed or read by, the public in Hong Kong (except if permitted to do so under the laws of Hong Kong) other than with
respect to shares which are or are intended to be disposed of only to persons outside Hong Kong or only to "professional investors" within the meaning of the Securities and Futures Ordinance (Cap.571
Laws of Hong Kong) and any rules made thereunder.
Israel
The securities offered by this prospectus have not been approved or disapproved by the Israeli Securities Authority, or the ISA, nor have such
securities been registered for sale in Israel. The shares of common stock may not be offered or sold, directly or indirectly, to the public in Israel, absent the publication of a prospectus. The ISA
has not issued permits, approvals or licenses in connection with the Offering or publishing the prospectus; nor has it authenticated the details included herein, confirmed their reliability or
completeness, or rendered an opinion as to the quality of the securities being offered. Any resale in Israel, directly or indirectly, to the public of the securities offered by this prospectus is
subject to restrictions on transferability and must be effected only in compliance with the Israeli securities laws and regulations.
Japan
The securities have not been and will not be registered under the Financial Instruments and Exchange Law of Japan (the Financial Instruments and
Exchange Law) and may not be offered or sold, directly or indirectly, in Japan or to, or for the benefit of, any resident of Japan (which term as used herein means any person resident in Japan,
including any corporation or other entity organized under the laws of Japan), or to others for re-offering or resale, directly or indirectly, in Japan or to a resident of Japan, except pursuant to an
exemption from the registration requirements of, and otherwise in compliance with, the Financial Instruments and Exchange Law and any other applicable laws, regulations and ministerial guidelines of
Japan.
Singapore
This prospectus has not been registered as a prospectus with the Monetary Authority of Singapore. Accordingly, this prospectus and any other
document or material in connection with the offer or sale, or invitation for subscription or purchase, of the shares may not be circulated or distributed, nor may
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the
shares be offered or sold, or be made the subject of an invitation for subscription or purchase, whether directly or indirectly, to persons in Singapore other than (i) to an institutional
investor under Section 274 of the Securities and Futures Act, Chapter 289 of Singapore (SFA), (ii) to a relevant person, or any person pursuant to Section 275(1A), and in
accordance with the conditions, specified in Section 275 of the SFA or (iii) otherwise pursuant to, and in accordance with the conditions of, any other applicable provision of the SFA.
Where
the shares are subscribed or purchased under Section 275 by a relevant person which is: (a) a corporation (which is not an accredited investor) the sole business of
which is to hold investments and the entire share capital of which is owned by one or more individuals, each of whom is an accredited investor; or (b) a trust (where the trustee is not an
accredited investor) whose sole purpose is to hold investments and each beneficiary is an accredited investor, shares, debentures and units of shares and debentures of that corporation or the
beneficiaries' rights and interest in that trust shall not be transferable for six months after that corporation or that trust has acquired the shares under Section 275 except: (1) to an
institutional investor under Section 274 of the SFA or to a relevant person,
or any person pursuant to Section 275(1A), and in accordance with the conditions, specified in Section 275 of the SFA; (2) where no consideration is given for the transfer; or
(3) by operation of law.
United Kingdom
In addition, in the United Kingdom, this document is being distributed only to, and is directed only at, and any offer subsequently made may
only be directed at persons who are "qualified investors" (as defined in the Prospectus Directive) (i) who have professional experience in matters relating to investments falling within
Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended, which we refer to as the Order, or (ii) who are high net worth companies (or
persons to whom it may otherwise be lawfully communicated) falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as "relevant persons"). This
document must not be acted on or relied on in the United Kingdom by persons who are not relevant persons. In the United Kingdom, any investment or investment activity to which this document relates is
only available to, and will be engaged in with, relevant persons.
Switzerland
The Prospectus does not constitute an issue prospectus pursuant to Article 652a or Article 1156 of the Swiss Code of Obligations
("CO") and the shares will not be listed on the SIX Swiss Exchange. Therefore, the Prospectus may not comply with the disclosure standards of the CO or the listing rules (including any prospectus
schemes) of the SIX Swiss Exchange. Accordingly, the shares may not be offered to the public in or from Switzerland, but only to a selected and limited circle of investors, which do not subscribe to
the shares with a view to distribution.
LEGAL MATTERS
The validity of the common stock being offered in this offering will be passed upon for us by Morgan, Lewis & Bockius LLP,
Princeton, New Jersey. Certain legal matters related to this offering will be passed upon for the underwriters by Latham & Watkins LLP.
EXPERTS
The financial statements of Agile Therapeutics, Inc. appearing in Agile Therapeutics, Inc.'s Annual Report (Form 10-K) for
the year ended December 31, 2016 have been audited by Ernst & Young LLP, independent registered public accounting firm, as set forth in their report thereon, included therein, and
incorporated herein by reference. Such financial statements are incorporated herein by reference in reliance upon such report given on the authority of such firm as experts in accounting and auditing.
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WHERE YOU CAN FIND MORE INFORMATION
This prospectus supplement and the accompanying prospectus form part of a registration statement on Form S-3 that we filed with the SEC.
This prospectus supplement and the accompanying prospectus do not contain all of the information set forth in the registration statement and the exhibits to the registration statement or the documents
incorporated by reference herein and therein. For further information with respect to us and the securities that we are offering under this prospectus supplement, we refer you to the registration
statement and the exhibits and schedules filed as a part of the registration statement and the documents incorporated by reference herein and therein. You should rely only on the information contained
in this prospectus supplement or the accompanying prospectus or incorporated by reference herein or therein. We have not authorized anyone else to provide you with different information. We are not
making an offer of these securities in any state where the offer is not permitted. You should not assume that the information in this prospectus is accurate as of any date other than the date on the
front page of this prospectus supplement, regardless of the time of delivery of this prospectus supplement or any sale of the securities offered hereby.We file annual, quarterly and current reports,
proxy statements and other information with the SEC. You may read and copy the registration statement, as well as any other document filed by us with the SEC, at the SEC's Public Reference Room at
100 F Street NE, Washington, D.C. 20549. You can also request copies of these documents by writing to the SEC and paying a fee for the copying cost. You may obtain information on the operation
of the Public Reference Room by calling the SEC at (800) SEC-0330. The SEC maintains a website that contains reports, proxy statements and other information regarding
issuers that file electronically with the SEC, including Agile Therapeutics. The address of the SEC website is www.sec.gov.
We
maintain a website at www.agiletherapeutics.com. Information contained in or accessible through our website does not constitute a part of this prospectus.
INCORPORATION OF CERTAIN INFORMATION BY REFERENCE
The SEC allows us to "incorporate by reference" information into this prospectus supplement, which means that we can disclose important
information to you by referring you to another document filed separately with the SEC. The SEC file number for the documents incorporated by reference in this prospectus is 001-36464. The documents
incorporated by reference into this prospectus supplement contain important information that you should read about us.
The
following documents are incorporated by reference into this document:
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our Annual Report on Form 10-K for the fiscal year ended December 31, 2016 filed with the SEC on March 15, 2017;
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our Quarterly Report on Form 10-Q for the three months ended March 31, 2017 filed with the SEC on May 8, 2017;
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our Quarterly Report on Form 10-Q for the six months ended June 30, 2017 filed with the SEC on July 28, 2017;
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those portions of our Definitive Proxy Statement on Schedule 14A for our 2017 Annual Meeting of Stockholders filed with the SEC on
April 24, 2017 that are incorporated by reference into our Annual Report on Form 10-K for the fiscal year ended December 31, 2016;
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the description of our Current Reports on Form 8-K filed with the SEC on January 3, 2017; March 16, 2017; April 11,
2017; April 17, 2017; May 2, 2017; May 8, 2017 (with respect to Item 8.01 only); June 8, 2017; June 27, 2017; July 28, 2017 (with respect to the
Current Report on Form 8-K reporting under Item 8.01); and August 2, 2017; and
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the description of our common stock, which is registered under Section 12 of the Exchange Act, in our registration statement on
Form 8-A, filed with the SEC on May 20, 2014, including any amendments or reports filed for the purpose of updating such description.
We
also incorporate by reference into this prospectus all documents (other than current reports furnished under Item 2.02 or Item 7.01 of Form 8-K and exhibits filed
on such form that are related to such items) that are filed by us with the SEC pursuant to Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act after the date of this prospectus supplement
but prior to the termination of the offering. These documents include periodic reports, such as Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on
Form 8-K, as well as proxy statements.
We
will provide to each person, including any beneficial owner, to whom a prospectus is delivered, without charge upon written or oral request, a copy of any or all of the documents that
are incorporated by reference into this prospectus but not delivered with the prospectus, including exhibits which are specifically incorporated by reference into such documents. Requests should be
directed to: Agile Therapeutics, Inc., Attn: Investor Relations, 101 Poor Farm Road, Princeton, New Jersey 08540. Our telephone number is (609) 683-1880.
Any
statement contained herein or in a document incorporated or deemed to be incorporated by reference into this document will be deemed to be modified or superseded for purposes of the
document to the extent that a statement contained in this document or any other subsequently filed
document that is deemed to be incorporated by reference into this document modifies or supersedes the statement.
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PROSPECTUS
$150,000,000
AGILE THERAPEUTICS, INC.
Common Stock
Preferred Stock
Warrants
Debt Securities
Rights to Purchase Common Stock, Preferred Stock,
Debt Securities or Units
Units
We may offer and sell from time to time our shares of common stock, shares of preferred stock, warrants, debt securities and rights to purchase
common stock, preferred stock, debt securities or units, as well as units that include any of these securities. We may sell any combination of these securities in one or more offerings with an
aggregate initial offering price of up to $150,000,000.
This
prospectus provides you with a general description of the securities we may offer. Each time we offer securities pursuant to this prospectus, we will provide a prospectus supplement
containing specific terms of the particular offering together with this prospectus. You should read this prospectus and the applicable prospectus supplement carefully before you invest in any
securities. The prospectus supplement also may add, update or change information contained in this prospectus. This prospectus may not be used to offer and sell securities unless accompanied by the
applicable prospectus supplement.
Our
common stock is listed on the NASDAQ Global Market under the symbol "AGRX." On June 18, 2015, the closing price of our common stock was $9.25.
Investing in our securities involves significant risks. We strongly recommend that you read carefully the risks we describe in this prospectus and
in any accompanying prospectus supplement, as well as the risk factors that are incorporated by reference into this prospectus from our filings made with the Securities and Exchange Commission. See
"Risk Factors" on page 3 of this prospectus.
We may sell the securities directly or to or through underwriters or dealers, and also to other purchasers or through agents. The names of any
underwriters or agents that are included in a sale of securities to you, and any applicable commissions or discounts, will be stated in an accompanying prospectus supplement. In addition, the
underwriters, if any, may over-allot a portion of the securities.
Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed upon the adequacy or
accuracy of this prospectus. Any representation to the contrary is a criminal offense.
The
date of this prospectus is July 1, 2015
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ABOUT THIS PROSPECTUS
This prospectus is part of a registration statement that we filed with the Securities and Exchange Commission, (the "SEC"), using a "shelf"
registration process. Under this shelf registration process, we may offer and sell from time to time any combination of the securities described in this prospectus in one or more offerings in amounts,
at prices and on terms that we determine at the time of the offering, with an aggregate initial offering price of up to $150,000,000. This prospectus provides you with a general description of the
securities we may offer. Each time we offer securities under this registration statement we will provide a prospectus supplement that describes the terms of the relevant offering. The prospectus
supplement also may add, update or change information contained in this prospectus. Before making an investment decision, you should read carefully both this prospectus and any prospectus supplement
together with the documents incorporated by reference into this prospectus as described below under the heading "Information Incorporated by Reference."
The
registration statement that contains this prospectus, including the exhibits to the registration statement and the information incorporated by reference, provides additional
information about us and our securities. That registration statement can be read at the SEC website (www.sec.gov) or at the SEC public reference room, as discussed below under the heading "Where You
Can Find More Information."
You
should rely only on the information provided in the registration statement, this prospectus and in any prospectus supplement, including the information incorporated by reference. We
have not authorized anyone to provide you with different information. You should not assume that the information in this prospectus or any supplement to this prospectus is accurate at any date other
than the date indicated on the cover page of these documents or the filing date of any document incorporated by reference, regardless of its time of delivery. We are not making an offer to sell the
securities in any jurisdiction where the offer or sale is not permitted.
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We may sell our securities to or through underwriters, initial purchasers, dealers or agents, directly to purchasers or through a combination of any of these
methods of sale, as designated from time to time. We and our agents reserve the sole right to accept or reject in whole or in part any proposed purchase of our securities. An applicable prospectus
supplement, which we will provide each time we offer the securities, will set forth the names of any underwriters, initial purchasers, dealers or agents involved in the sale of our securities, and any
related fee, commission or discount arrangements. See "Plan of Distribution."
The
terms "Agile," the "Company," "our," "us" and "we," as used in this prospectus, refer to Agile Therapeutics, Inc., unless we state otherwise or the context indicates
otherwise.
AGILE THERAPEUTICS, INC.
We are a women's health specialty pharmaceutical company focused on the development and commercialization of new prescription contraceptive
products. Our product candidates are designed to provide women with contraceptive options that offer greater convenience and facilitate compliance. We have developed a proprietary transdermal patch
technology, called Skinfusion®, which is designed to provide advantages over currently available patches and is intended to optimize patch adherence and stability and patient comfort. Our
lead product candidate, Twirla®, also known as AG200-15, is a once-weekly prescription contraceptive patch currently in Phase 3 clinical development. Twirla is a combined hormonal
contraceptive, or CHC, patch that contains the active ingredients ethinyl estradiol, or EE, which is a synthetic estrogen, and levonorgestrel, or LNG, which is a type of progestin, a synthetic steroid
hormone, both of which have an established history of efficacy and safety in currently marketed combination low-dose, oral contraceptives.
We
have conducted a comprehensive clinical program, with completed Phase 1, Phase 2, and Phase 3 trials enrolling over 2,100 women, over 1,500 of whom received
Twirla. We have filed a Section 505(b)(2) New Drug Application, or NDA, for approval of Twirla by the U.S. Food and Drug Administration, or FDA, which is required before marketing a new drug in
the United States. Our 505(b)(2) NDA relies in part on clinical trials that we conducted and in part on the FDA's findings of safety and efficacy from investigations for approved products containing
the active ingredients and published scientific literature for which we have not obtained a right of reference. The FDA has indicated in a Complete Response Letter, or CRL, that our NDA was not
sufficient for approval as originally submitted. After multiple communications with the FDA, we have received significant guidance as to what additional clinical development and other activities need
to be completed prior to approval. In accordance with the FDA's advice and comments, we are conducting an additional Phase 3 clinical trial which was initiated in 2014 and is currently
enrolling subjects. Based on the guidance that we received from the FDA, we believe that this additional trial will address all of the clinical issues raised in the CRL. Following completion of this
additional Phase 3 clinical trial, we will respond to the CRL and supplement our NDA with the results of the trial.
In
addition to Twirla, we are developing a pipeline of other new transdermal contraceptive products, including AG200-ER, which is a regimen designed to allow a woman to extend the length
of her cycle, AG200-SP, which is a regimen designed to provide a shortened hormone-free interval, and AG890, which is a progestin-only contraceptive patch intended for use by women who are unable or
unwilling to take estrogen.
Our
principal executive offices are located at 101 Poor Farm Road, Princeton, New Jersey 08540, and our telephone number is (609) 683-1880. Our website address is
www.agiletherapeutics.com. The information contained on our website is not incorporated by reference into this prospectus, and you should not consider any information contained on, or that can be
accessed through, our website as part of this prospectus or in deciding whether to purchase our common stock.
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Our
filings with the SEC are posted on our website at www.agiletherapeutics.com. The information found on our website is not part of this or any other report we file with or furnish to
the SEC. The public can also obtain copies of these filings by visiting the SEC's Public Reference Room at 100 F Street NE, Washington DC 20549, or by calling the SEC at
1-800-SEC-0330 or by accessing the SEC's website at www.sec.gov.
FORWARD-LOOKING STATEMENTS
From time to time, in reports filed with the Securities and Exchange Commission (including this registration statement), in press releases and
in other communications to stockholders or the investment community, we may provide forward-looking statements concerning possible or anticipated future results of operations or business developments.
These statements are based on our management's current expectations or predictions of future conditions, events or results based on various assumptions and our management's estimates of trends and
economic factors in the markets in which we are active, as well as our business plans. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates," "projects,"
"forecasts," "may," "should," and variations of such words and similar expressions are intended to identify such forward-looking statements. The forward-looking statements may include, without
limitation, statements regarding product candidate development, product candidate potential, regulatory environment, sales and marketing strategies, capital resources or operating performance. The
forward-looking statements are subject to risks and uncertainties, which may cause results to differ materially from those set forth in the statements. Forward-looking statements in this registration
statement should be evaluated together with the many uncertainties that affect our business and our market, particularly those discussed in the "Risk Factors" section of our Annual Report on
Form 10-K for the year ended December 31, 2014 and our subsequent filings, which are incorporated by reference into this prospectus, to better understand the risks and uncertainties
inherent in our business and underlying any forward-looking statements. Forward-looking statements are not guarantees of future performance, and actual results may differ materially from those
projected. The forward-looking statements are representative only as of the date of this prospectus and except as required by law, we assume no responsibility to update any forward-looking statements,
whether as a result of new information, future events or otherwise.
You
should read this prospectus and the documents that we reference in this prospectus and have been filed as exhibits to the registration statement of which this prospectus is a part
completely and with the understanding that our actual future results may be materially different from what we expect. The information contained in this prospectus is accurate only as of the date of
this prospectus, regardless of the time of delivery of this prospectus or any issuance or sale of our common shares. Except as required by law, we do not assume any obligation to update any
forward-looking statements.
RISK FACTORS
Investing in our securities involves risk. You should carefully consider the specific risks discussed or incorporated by reference into the
applicable prospectus supplement, together with all the other information contained in the prospectus supplement or incorporated by reference into this prospectus and the applicable prospectus
supplement. You should also consider the risks, uncertainties and assumptions discussed under the caption "Risk Factors" included in our Annual Report on Form 10-K for the year ended
December 31, 2014 and in subsequent filings, which are incorporated by reference into this prospectus. These risk factors may be amended, supplemented or superseded from time to time by other
reports we file with the SEC in the future or by a prospectus supplement relating to a particular offering of our securities. These risks and uncertainties are not the only risks and uncertainties we
face. Additional risks and uncertainties not presently known to us, or that we currently view as immaterial, may also impair our business. If any of the risks or uncertainties described in our SEC
filings or any prospectus supplement or any additional risks and uncertainties actually occur, our
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business,
financial condition and results of operations could be materially and adversely affected. In that case, the trading price of our securities could decline and you might lose all or part of
your investment.
RATIO OF EARNINGS TO FIXED CHARGES AND PREFERRED STOCK DIVIDEND
REQUIREMENTS
The following table sets forth our ratio of earnings to fixed charges and our ratio of earnings to combined fixed charges and preferred stock
dividends for each of the periods indicated. You should read this table in conjunction with the financial statements and notes incorporated by reference in this registration statement.
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Three Months
Ended March 31,
2015
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Year Ended
December 31,
2014
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Year Ended
December 31,
2013
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Year Ended
December 31,
2012
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Ratios of earnings to combined fixed charges and preferred stock dividends(1)(2)
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Due
to our losses for the three months ended March 31, 2015 and the years ended December 31, 2014, 2013 and 2012, the coverage ratio was less than 1:1.
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We
would have needed to generate additional earnings of $8.5 million, $19.7 million, $14.3 million and $23.3 million for the three months
ended March 31, 2015 and the years ended December 31, 2014, 2013 and 2012, respectively, to cover our fixed charges and our combined fixed charges and preferred stock dividends in those
periods.
USE OF PROCEEDS
Unless otherwise indicated in the applicable prospectus supplement, we will use the net proceeds from the sale of the securities offered hereby
for general corporate purposes, which include, but are not limited to, providing financing for clinical trials, capital expenditures, additions to working capital, the commercial launch of Twirla, if
and when it receives regulatory approval, scaling and validating our manufacturing process for commercial launch of Twirla, development of our product candidate pipeline including Twirla line
extensions, general and administrative expenses or other corporate obligations. We may use a portion of the net proceeds to pay off outstanding indebtedness, if any, and/or acquire or invest in
businesses, products and technologies.
DESCRIPTION OF CAPITAL STOCK
The following description is a general summary of the terms of the shares of common stock or shares of preferred stock that we may issue. The
description below and in any prospectus supplement does not include all of the terms of the shares of common stock or shares of preferred stock and should be read together with our Amended Restated
Certificate of Incorporation and Amended and Restated Bylaws, copies of which have been filed previously with the SEC. For more information on how you can obtain copies of our Amended and Restated
Certificate of Incorporation and Amended and Restated Bylaws, see "Where You Can Find More Information."
Common Stock
General
Our Amended and Restated Certificate of Incorporation provides the authority to issue 150,000,000 shares of common stock, par value $0.0001 per
share. At June 18, 2015, there were
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22,235,137
shares of common stock outstanding. Each share of our common stock has the same relative rights and is identical in all respects to each other share of our common stock. The rights,
preferences and privileges of holders of our common stock are subject to the rights, preferences and privileges of the holders of shares of any series of preferred stock that we have issued or may
issue in the future.
Voting Rights
The holders of our common stock are entitled to one vote per share on any matter to be voted upon by our stockholders. Our Amended and Restated
Certificate of Incorporation, does not permit cumulative voting in connection with the election of directors.
Dividends
The holders of our common stock are entitled to dividends, if any, as our Board of Directors may declare from time to time from funds legally
available for that purpose, subject to the holders of other classes of stock, if any, at the time outstanding having prior rights as to dividends, if any.
Liquidation Rights
Upon any voluntary or involuntary liquidation, dissolution, or winding up of our affairs, the holders of our common stock are entitled to share
ratably in all assets remaining after the payment of creditors, subject to any prior liquidation distribution rights of holders of other classes of stock, if any, at the time outstanding.
Miscellaneous
Holders of our common stock have no preemptive, conversion, redemption or sinking fund rights. The outstanding shares of our common stock are,
and the shares of common stock to be offered hereby when issued will be, validly issued, fully paid and non-assessable.
NASDAQ Listing
Our common stock is listed on the NASDAQ Global Market under the symbol "AGRX."
Transfer Agent and Registrar
The transfer agent and registrar for our common stock is Broadridge Corporate Issuer Solutions, Inc. whose address is
P.O. Box 1342, Brentwood, NY 11717.
Preferred Stock
General
Our Amended and Restated Certificate of Incorporation authorizes the issuance of up to 10,000,000 shares of preferred stock, par value $0.0001
per share, none of which are issued and outstanding as of the date of this prospectus. We may issue, from time to time in one or more series, the terms of which may be determined at the time of
issuance by our board of directors, without further action by our stockholders, shares of preferred stock and such shares may include voting rights, preferences as to dividends and liquidation,
conversion rights, redemption rights and sinking fund provisions. The shares of each series of preferred stock shall have preferences, limitations and relative rights, including voting rights,
identical with those of other shares of the same series and, except to the extent provided in the description of such series, of those of other series of preferred stock.
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The
issuance of any preferred stock could adversely affect the rights of the holders of common stock and, therefore, reduce the value of the common stock. The ability of our board of
directors to issue preferred stock could discourage, delay or prevent a takeover or change in control.
The
description of the terms of a particular series of preferred stock in the applicable prospectus supplement will not be complete. You should refer to the applicable certificate of
designation for complete information regarding a series of preferred stock. The prospectus supplement will also contain a description of U.S. federal income tax consequences relating to the preferred
stock, if material.
The
terms of any particular series of preferred stock will be described in the prospectus supplement relating to that particular series of preferred stock, including, where
applicable:
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the series designation, stated value and liquidation preference of such preferred stock and the number of shares offered;
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the offering price;
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the dividend rate or rates (or method of calculation), the date or dates from which dividends shall accrue, and whether such dividends shall be
cumulative or noncumulative and, if cumulative, the dates from which dividends shall commence to cumulate;
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any redemption or sinking fund provisions;
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the amount that shares of such series shall be entitled to receive in the event of our liquidation, dissolution or winding-up;
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the terms and conditions, if any, on which shares of such series shall be convertible or exchangeable for shares of our stock of any other
class or classes, or other series of the same class;
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the voting rights, if any, of shares of such series in addition to those set forth under the caption entitled, "Voting Rights" below;
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the status as to reissuance or sale of shares of such series redeemed, purchased or otherwise reacquired, or surrendered to us on conversion or
exchange;
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the conditions and restrictions, if any, on the payment of dividends or on the making of other distributions on, or the purchase, redemption or
other acquisition by us, of our common stock or of any other class of our stock ranking junior to the shares of such series as to dividends or upon liquidation (including, but not limited to, at such
times as there are arrearages in the payment of dividends or sinking fund installments);
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the conditions and restrictions, if any, on the creation of Company indebtedness, or on the issue of any additional stock ranking on a parity
with or prior to the shares of such series as to dividends or upon liquidation; and
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any additional dividend, liquidation, redemption, sinking or retirement fund and other rights, preferences, privileges, limitations and
restrictions of such preferred stock.
If
we issue shares of preferred stock under this prospectus and any related prospectus supplement, the shares will be fully paid and non-assessable and will not have, or be subject to,
any preemptive or similar rights.
Voting Rights
The General Corporation Law of Delaware provides that the holders of preferred stock will have the right to vote separately as a class on any
proposal involving fundamental changes in the rights of
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holders
of that preferred stock. This right is in addition to any voting rights that may be provided for in the applicable certificate of designation.
Transfer Agent and Registrar
The transfer agent and registrar for any series of preferred stock will be set forth in the applicable prospectus supplement.
Other
Our issuance of preferred stock could decrease the amount of earnings and assets available for distribution to the holders of common stock or
could adversely affect the rights and powers, including voting rights, of the holders of common stock. The issuance of preferred stock could have the effect of decreasing the market price of our
common stock.
Delaware Law and Certain Amended and Restated Certificate of Incorporation and Amended and Restated
Bylaws Provisions
Our Amended and Restated Certificate of Incorporation and Amended and Restated Bylaws to be in effect upon completion of this offering contain
provisions that could delay or prevent a change of control of our company or changes in our board of directors that our stockholders might consider favorable. Some of these
provisions:
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Authorize the issuance of preferred stock which can be created and issued by the board of directors without prior stockholder approval, with
rights senior to those of our common stock;
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Provide for a classified board of directors, with each director serving a staggered three-year term;
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Prohibit our stockholders from filling board vacancies, calling special stockholder meetings or taking action by written consent;
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Provide for the removal of a director only with cause and by the affirmative vote of the holders of 75% or more of the shares then entitled to
vote at an election of our directors;
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Require advance written notice of stockholder proposals and director nominations; and
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Require any action instituted against our officers or directors in connection with their service to the Company to be brought in the state of
Delaware.
In
addition, we are subject to the provisions of Section 203 of the Delaware General Corporation Law, which may prohibit certain business combinations with stockholders owning 15%
or more of our outstanding voting stock. These and other provisions in our Amended and Restated Certificate of Incorporation, Amended and Restated Bylaws and Delaware law could make it more difficult
for stockholders or potential acquirors to obtain control of our board of directors or initiate actions that are opposed by our then-current board of directors, including a merger, tender offer or
proxy contest involving our company. This provision could have the effect of delaying or preventing a change of control, whether or not it is desired by or beneficial to our stockholders. Any delay or
prevention of a change of control transaction or changes in our board of directors could cause the market price of our common stock to decline.
Our Amended and Restated Certificate of Incorporation contains provisions permitted under the General Corporation Law of Delaware relating to
the liability of directors. The provisions eliminate, to the extent legally permissible, a director's liability for monetary damages for a breach of fiduciary duty,
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except
in circumstances involving wrongful acts, such as the breach of a director's duty of loyalty or acts or omissions that involve intentional misconduct or a knowing violation of law. The
limitation of liability described above does not alter the liability of our directors and officers under federal securities laws. Furthermore, our Amended and Restated Certificate of Incorporation
contains provisions to indemnify our directors and officers to the fullest extent permitted by the General Corporation Law of Delaware. These provisions do not limit or eliminate our right or the
right of any stockholder of ours to seek non-monetary relief, such as an injunction or rescission in the event of a breach by a director or an officer of his duty of care to us. We believe that these
provisions assist us in attracting and retaining qualified individuals to serve as directors.
DESCRIPTION OF WARRANTS
We may issue warrants for the purchase of shares of our common stock, shares of our preferred stock or debt securities. The following
description sets forth certain general terms and provisions of the warrants that we may offer pursuant to this prospectus. The particular terms of the warrants and the extent, if any, to which the
general terms and provisions may apply to the warrants so offered will be described in the applicable prospectus supplement.
Warrants
may be issued independently or together with other securities and may be attached to or separate from any offered securities. Each series of warrants will be issued under a
separate warrant agreement to be entered into between us and a bank or trust company, as warrant agent. The warrant agent will act solely as our agent in connection with the warrants and will not have
any obligation or relationship of agency or trust for or with any holders or beneficial owners of warrants.
A
copy of the forms of the warrant agreement and the warrant certificate relating to any particular issue of warrants will be filed with the SEC each time we issue warrants, and you
should read those documents for provisions that may be important to you. For more information on how you can obtain copies of the forms of the warrant agreement and the related warrant certificate,
see "Where You Can Find More Information."
Stock Warrants
The prospectus supplement relating to a particular issue of warrants to issue shares of our common stock or shares of our preferred stock will
describe the terms of the common share warrants and preferred share warrants, including the following:
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the title of the warrants;
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the offering price for the warrants, if any;
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the aggregate number of the warrants;
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the designation and terms of the shares of common stock or shares of preferred stock that may be purchased upon exercise of the warrants;
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the terms for changes or adjustments to the exercise price of the warrants;
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if applicable, the designation and terms of the securities that the warrants are issued with and the number of warrants issued with each
security;
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if applicable, the date from and after which the warrants and any securities issued with the warrants will be separately transferable;
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the number of shares of common stock or shares of preferred stock that may be purchased upon exercise of a warrant and the price at which the
shares may be purchased upon exercise;
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the dates on which the right to exercise the warrants commence and expire;
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if applicable, the minimum or maximum amount of the warrants that may be exercised at any one time;
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the currency or currency units in which the offering price, if any, and the exercise price are payable;
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if applicable, a discussion of material United States federal income tax considerations;
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anti-dilution provisions of the warrants, if any;
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redemption or call provisions, if any, applicable to the warrants;
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any additional terms of the warrants, including terms, procedures and limitations relating to the exchange and exercise of the warrants; and
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any other information we think is important about the warrants.
Debt Warrants
The prospectus supplement relating to a particular issue of warrants to issue debt securities will describe the terms of those warrants,
including the following:
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the title of the warrants;
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the offering price for the warrants, if any;
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the aggregate number of the warrants;
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the designation and terms of the debt securities purchasable upon exercise of the warrants;
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the terms for changes or adjustments to the exercise price of the warrants;
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if applicable, the designation and terms of the debt securities that the warrants are issued with and the number of warrants issued with each
debt security;
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if applicable, the date from and after which the warrants and any debt securities issued with them will be separately transferable;
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the principal amount of debt securities that may be purchased upon exercise of a warrant and the price at which the debt securities may be
purchased upon exercise;
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the dates on which the right to exercise the warrants will commence and expire;
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-
if applicable, the minimum or maximum amount of the warrants that may be exercised at any one time;
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whether the warrants represented by the warrant certificates or debt securities that may be issued upon exercise of the warrants will be issued
in registered or bearer form;
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-
information relating to book-entry procedures, if any;
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the currency or currency units in which the offering price, if any, and the exercise price are payable;
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-
if applicable, a discussion of material United States federal income tax considerations;
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anti-dilution provisions of the warrants, if any;
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-
redemption or call provisions, if any, applicable to the warrants;
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any additional terms of the warrants, including terms, procedures and limitations relating to the exchange and exercise of the warrants; and
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any other information we think is important about the warrants.
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Exercise of Warrants
Each warrant will entitle the holder of the warrant to purchase at the exercise price set forth in the applicable prospectus supplement the
number of shares of common stock, shares of preferred stock or the principal amount of debt securities being offered. Holders may exercise warrants at any time up to the close of business on the
expiration date set forth in the applicable prospectus supplement. After the close of business on the expiration date, unexercised warrants are void. Holders may exercise warrants as set forth in the
prospectus supplement relating to the warrants being offered.
Until
a holder exercises the warrants to purchase our shares of common stock, shares of preferred stock or debt securities, the holder will not have any rights as a holder of our shares
of common stock, shares of preferred stock or debt securities, as the case may be, by virtue of ownership of warrants.
DESCRIPTION OF DEBT SECURITIES
The following is a general description of the terms of debt securities we may issue from time to time unless we provide otherwise in the
applicable prospectus supplement. Particular terms of any debt securities we offer will be described in the prospectus supplement relating to such debt securities.
As
required by Federal law for all bonds and notes of companies that are publicly offered, any debt securities we issue will be governed by a document called an "indenture," the form of
which is filed as an exhibit to the registration statement of which this prospectus forms a part. We have summarized the general features of the debt securities to be governed by the indenture.
The summary is not complete. An indenture is a contract between us and a financial institution acting as trustee on behalf of the holders of the debt securities, and is subject to and governed by the
Trust Indenture Act of 1939, as amended. The trustee has two main roles. First, the trustee can enforce holders' rights against us if we
default. There are some limitations on the extent to which the trustee acts on holders' behalf, described in the second paragraph under "Description of Debt SecuritiesEvents of Default."
Second, the trustee performs certain administrative duties, such as sending interest and principal payments to holders.
Because
this section is a summary, it does not describe every aspect of any debt securities we may issue or the indenture governing any such debt securities. Particular terms of any debt
securities we offer will be described in the prospectus supplement relating to such debt securities, and we urge you to read the applicable executed indenture, which will be filed with the SEC at the
time of any offering of debt securities, because it, and not this description, will define the rights of holders of such debt securities.
A
prospectus supplement will describe the particular terms of any series of debt securities we may issue, including some or all of the
following:
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the designation or title of the series of debt securities;
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-
the total principal amount of the series of debt securities, the denominations in which the offered debt securities will be issued and whether
the offering may be reopened for additional securities of that series and on what terms;
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-
the percentage of the principal amount at which the series of debt securities will be offered;
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the date or dates on which principal will be payable;
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the rate or rates (which may be either fixed or variable) and/or the method of determining such rate or rates of interest, if any;
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the date or dates from which any interest will accrue, or the method of determining such date or dates, and the date or dates on which any
interest will be payable;
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the terms for redemption, extension or early repayment, if any;
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the currencies in which the series of debt securities are issued and payable;
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-
whether the amount of payments of principal, interest or premium, if any, on a series of debt securities will be determined with reference to
an index, formula or other method and how these amounts will be determined;
-
-
the place or places of payment, transfer, conversion and/or exchange of the debt securities;
-
-
the provision for any sinking fund;
-
-
any restrictive covenants;
-
-
events of default;
-
-
whether the series of debt securities are issuable in certificated form;
-
-
any provisions for legal defeasance or covenant defeasance;
-
-
whether and under what circumstances we will pay additional amounts in respect of any tax, assessment or governmental charge and, if so,
whether we will have the option to redeem the debt securities rather than pay the additional amounts (and the terms of this option);
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any provisions for convertibility or exchangeability of the debt securities into or for any other securities;
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-
whether the debt securities are subject to subordination and the terms of such subordination;
-
-
any listing of the debt securities on any securities exchange;
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-
if applicable, a discussion of certain U.S. Federal income tax considerations, including those related to original issue discount, if
applicable; and
-
-
any other material terms.
The
debt securities may be secured or unsecured obligations. Unless the prospectus supplement states otherwise, principal, interest and premium, if any, will be paid by us in immediately
available funds.
General
The indenture may provide that any debt securities proposed to be sold under this prospectus and the applicable prospectus supplement relating
to such debt securities ("offered debt securities") and any debt securities issuable upon conversion or exchange of other offered securities ("underlying debt securities") may be issued under the
indenture in one or more series.
For
purposes of this prospectus, any reference to the payment of principal of, or interest or premium, if any, on, debt securities will include additional amounts if required by the
terms of the debt securities.
Debt
securities issued under an indenture, when a single trustee is acting for all debt securities issued under the indenture, are called the "indenture securities." The indenture may
also provide that there may be more than one trustee thereunder, each with respect to one or more different series of securities issued thereunder. See "Description of Debt
SecuritiesResignation of Trustee" below. At a time when two or more trustees are acting under an indenture, each with respect to only certain series, the term "indenture securities" means
the one or more series of debt securities with respect to which each respective trustee is acting. In the event that there is more than one trustee under an indenture, the powers and trust obligations
of each trustee described in this prospectus will extend only to the one or more series of indenture securities for which it is trustee. If two or more trustees are acting under
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an
indenture, then the indenture securities for which each trustee is acting would be treated as if issued under separate indentures.
We
refer you to the applicable prospectus supplement relating to any debt securities we may issue from time to time for information with respect to any deletions from, modifications of
or additions to the Events of Default or covenants that are described below, including any addition of a covenant or other provision providing event risk or similar protection, that will be applicable
with respect to such debt securities.
We
have the ability to issue indenture securities with terms different from those of indenture securities previously issued and, without the consent of the holders thereof, to reopen a
previous issue of a series of indenture securities and issue additional indenture securities of that series unless the reopening was restricted when that series was created.
Conversion and Exchange
If any debt securities are convertible into or exchangeable for other securities, the related prospectus supplement will explain the terms and
conditions of the conversion or exchange, including the conversion price or exchange ratio (or the calculation method), the conversion or exchange period (or how the period will be determined), if
conversion or exchange will be mandatory or at the option of the holder or us, provisions for adjusting the conversion price or the exchange ratio and provisions affecting conversion or exchange in
the event of the redemption of the underlying debt securities. These terms may also include provisions under which the number or amount of other securities to be received by the holders of the debt
securities upon conversion or exchange would be calculated according to the market price of the other securities as of a time stated in the prospectus supplement.
Payment and Paying Agents
We will pay interest to the person listed in the applicable trustee's records as the owner of the debt security at the close of business on a
particular day in advance of each due date for
interest, even if that person no longer owns the debt security on the interest due date. That day, often approximately two weeks in advance of the interest due date, is called the "record date."
Because we will pay all the interest for an interest period to the holders on the record date, holders buying and selling debt securities must work out between themselves the appropriate purchase
price. The most common manner is to adjust the sales price of the debt securities to prorate interest fairly between buyer and seller based on their respective ownership periods within the particular
interest period. This prorated interest amount is called "accrued interest."
Events of Default
Holders of debt securities of any series will have rights if an Event of Default occurs in respect of the debt securities of such series and is
not cured, as described later in this subsection. The term "Event of Default" in respect of the debt securities of any series means any of the following:
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-
we do not pay the principal of, or any premium on, a debt security of the series on its due date;
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we do not pay interest on a debt security of the series within 30 days of its due date;
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we do not deposit any sinking fund payment in respect of debt securities of the series on its due date and we do not cure this default within
five days;
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we remain in breach of a covenant in respect of debt securities of the series for 90 days after we receive a written notice of default
stating we are in breach. The notice must be sent by either the trustee or holders of at least 25% of the principal amount of debt securities of the series;
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we file for bankruptcy or certain other events of bankruptcy, insolvency or reorganization occur; and
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any other Event of Default occurs in respect of debt securities of the series described in the prospectus supplement.
An
Event of Default for a particular series of debt securities does not necessarily constitute an Event of Default for any other series of debt securities issued under the same or any
other indenture. The trustee may withhold notice to the holders of debt securities of any default, except in the payment of principal, premium or interest, if it considers the withholding of notice to
be in the best interests of the holders.
If an Event of Default has occurred and has not been cured or waived, the trustee or the holders of not less than 25% in principal amount of the
debt securities of the affected series may declare the entire principal amount of all the debt securities of that series to be due and immediately payable. This is called a declaration of acceleration
of maturity. A declaration of acceleration of maturity may be canceled by the holders of a majority in principal amount of the debt securities of the affected series if the default is cured or waived
and certain other conditions are satisfied.
Except
in cases of default, where the trustee has some special duties, the trustee typically is not required to take any action under an indenture at the request of any holders unless
the holders offer the trustee reasonable protection from expenses and liability (called an "indemnity"). If reasonable indemnity is provided, the holders of a majority in principal amount of the
outstanding debt securities of the relevant series may direct the time, method and place of conducting any lawsuit or other formal
legal action seeking any remedy available to the trustee. The trustee may refuse to follow those directions in certain circumstances.
Before
a holder is allowed to bypass the trustee and bring its own lawsuit or other formal legal action or take other steps to enforce its rights or protect its interests relating to any
debt securities, the following must occur:
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the holder must give the trustee written notice that an Event of Default has occurred and remains uncured;
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the holders of at least 25% in principal amount of all outstanding debt securities of the relevant series must make a written request that the
trustee take action because of the default and must offer reasonable indemnity to the trustee against the cost and other liabilities of taking that action;
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the trustee must not have taken action for 60 days after receipt of the above notice and offer of indemnity; and
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the holders of a majority in principal amount of the debt securities must not have given the trustee a direction inconsistent with the above
notice during that 60-day period.
However,
a holder is entitled at any time to bring a lawsuit for the payment of money due on its debt securities on or after the due date. Each year, we will furnish to each trustee a
written statement of certain of our officers certifying that to their knowledge we are in compliance with the indenture and the debt securities, or else specifying any default.
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The holders of a majority in principal amount of the relevant series of debt securities may waive a default for all such series of debt
securities. If this happens, the default will be treated as if it had not occurred. No one can waive a payment default on a holder's debt security, however, without the holder's approval.
Merger or Consolidation
Under the terms of an indenture, we may be permitted to consolidate or merge with another entity. We may also be permitted to sell all or
substantially all of our assets to another entity. However, typically we may not take any of these actions unless all the following conditions are met:
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if we do not survive such transaction or we convey, transfer or lease our properties and assets substantially as an entirety, the acquiring
company must be a corporation, limited liability company, partnership or trust, or other corporate form, organized under the laws of any state of the United States or the District of Columbia, and
such company must agree to be legally responsible for our debt securities, and, if not already subject to the jurisdiction of any state of the United States or the District of Columbia, the new
company must submit to such jurisdiction for all purposes with respect to the debt securities and appoint an agent for service of process;
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alternatively, we must be the surviving company;
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immediately after the transaction no Event of Default will exist;
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we must deliver certain certificates and documents to the trustee; and
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we must satisfy any other requirements specified in the prospectus supplement relating to a particular series of debt securities.
Modification or Waiver
There are three types of changes we may make to an indenture and the debt securities issued thereunder.
First, there are changes that we cannot make to debt securities without specific approval of all of the holders. The following is a list of the
types of changes that may require specific approval:
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change the stated maturity of the principal of or rate of interest on a debt security;
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reduce any amounts due on a debt security;
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reduce the amount of principal payable upon acceleration of the maturity of a security following a default;
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at any time after a change of control has occurred, reduce any premium payable upon a change of control;
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change the place or currency of payment on a debt security (except as otherwise described in the prospectus or prospectus supplement);
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impair the right of holders to sue for payment;
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adversely affect any right to convert or exchange a debt security in accordance with its terms;
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reduce the percentage of holders of debt securities whose consent is needed to modify or amend the indenture;
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reduce the percentage of holders of debt securities whose consent is needed to waive compliance with certain provisions of the indenture or to
waive certain defaults;
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modify any other aspect of the provisions of the indenture dealing with supplemental indentures, modification and waiver of past defaults,
changes to the quorum or voting requirements or the waiver of certain covenants; and
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change any obligation we have to pay additional amounts.
The second type of change does not require any vote by the holders of the debt securities. This type is limited to clarifications and certain
other changes that would not adversely affect holders of the outstanding debt securities in any material respect, including the addition of covenants and guarantees. We also do not need any approval
to make any change that affects only debt securities to be issued under the indenture after the change takes effect.
Any other change to the indenture and the debt securities may require the following approval:
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if the change affects only one series of debt securities, it must be approved by the holders of a majority in principal amount of that series;
and
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if the change affects more than one series of debt securities issued under the same indenture, it must be approved by the holders of a majority
in principal amount of all of the series affected by the change, with all affected series voting together as one class for this purpose.
The
holders of a majority in principal amount of all of the series of debt securities issued under an indenture, voting together as one class for this purpose, may waive our compliance
obligations with respect to some of our covenants in that indenture. However, we cannot obtain a waiver of a payment default or of any of the matters covered by the bullet points included above under
"Description of Debt SecuritiesModification or WaiverChanges Requiring Approval."
When taking a vote on proposed changes to the indenture and the debt securities, we expect to use the following rules to decide how much
principal to attribute to a debt security:
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for original issue discount securities, we will use the principal amount that would be due and payable on the voting date if the maturity of
these debt securities were accelerated to that date because of a default;
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for debt securities whose principal amount is not known (for example, because it is based on an index), we will use a special rule for that
debt security described in the related prospectus supplement; and
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for debt securities denominated in one or more foreign currencies, we will use the U.S. dollar equivalent.
Debt
securities will not be considered outstanding, and therefore not eligible to vote, if we have deposited or set aside in trust money for their payment or redemption. Debt securities
will also not be eligible to vote if they have been fully defeased as described later under "Description of Debt SecuritiesDefeasanceLegal Defeasance."
We
generally will be entitled to set any day as a record date for the purpose of determining the holders of outstanding indenture securities that are entitled to vote or take other
action under the
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indenture.
If we set a record date for a vote or other action to be taken by holders of one or more series, that vote or action may be taken only by persons who are holders of outstanding indenture
securities of those series on the record date and must be taken within 11 months following the record date.
Book-entry
and other indirect holders will need to consult their banks or brokers for information on how approval may be granted or denied if we seek to change the indenture or the debt
securities or request a waiver.
Defeasance
The following provisions will be applicable to each series of debt securities unless we state in the applicable prospectus supplement that the
provisions of covenant defeasance and legal defeasance will not be applicable to that series.
We can make the deposit described below and be released from some of the restrictive covenants in the indenture under which the particular
series was issued. This is called "covenant defeasance." In that event, the holders would lose the protection of those restrictive covenants but would gain the protection of having money and
government securities set aside in trust to repay holders' debt securities. If applicable, a holder also would be released from the subordination provisions described under "Description of Debt
SecuritiesIndenture ProvisionsSubordination" below. In order to achieve covenant defeasance, we must do the following:
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If the debt securities of the particular series are denominated in U.S. dollars, we must deposit in trust for the benefit of all holders of
such debt securities a combination of money and U.S. government or U.S. government agency notes or bonds that will generate enough cash to make interest, principal and any other payments on the debt
securities on their various due dates;
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We may be required to deliver to the trustee a legal opinion of our counsel confirming that, under current U.S. Federal income tax law, we may
make the above deposit without causing the holders to be taxed on the debt securities any differently than if we did not make the deposit and just repaid the debt securities ourselves at maturity; and
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We must deliver to the trustee certain documentation stating that all conditions precedent to covenant defeasance have been complied with.
If
we accomplish covenant defeasance, holders can still look to us for repayment of the debt securities if there were a shortfall in the trust deposit or the trustee is prevented from
making payment. In fact, if one of the remaining Events of Default occurred (such as our bankruptcy) and the debt securities became immediately due and payable, there might be a shortfall. Depending
on the event causing the default, holders may not be able to obtain payment of the shortfall.
As described below, we can legally release ourselves from all payment and other obligations on the debt securities of a particular series
(called "legal defeasance"), (1) if there is a change in U.S. Federal tax law that allows us to effect the release without causing the holders to be taxed any differently than if the release
had not occurred, and (2) if we put in place the following other arrangements for holders to be repaid:
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If the debt securities of the particular series are denominated in U.S. dollars, we must deposit in trust for the benefit of all holders of
such debt securities a combination of money and U.S.
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If
we ever did accomplish legal defeasance, as described above, holders would have to rely solely on the trust deposit for repayment of the debt securities. Holders could not look to us
for repayment in the unlikely event of any shortfall. Conversely, the trust deposit would most likely be protected from claims of our lenders and other creditors if we ever became bankrupt or
insolvent. If applicable, holders would also be released from the subordination provisions described later under "Description of Debt SecuritiesIndenture
ProvisionsSubordination."
Resignation of Trustee
Each trustee may resign or be removed with respect to one or more series of indenture securities provided that a successor trustee is appointed
to act with respect to such series. In the event that two or more persons are acting as trustee with respect to different series of indenture securities under the indenture, each of the trustees will
be a trustee of a trust separate and apart from the trust administered by any other trustee.
Indenture ProvisionsSubordination
Upon any distribution of our assets upon our dissolution, winding up, liquidation or reorganization, the payment of the principal of (and
premium, if any) and interest on any indenture securities denominated as subordinated debt securities is to be subordinated to the extent provided in the indenture in right of payment to the prior
payment in full of all Senior Indebtedness (defined below), but our obligation to holders to make payment of the principal of (and premium, if any) and interest on such subordinated debt securities
will not otherwise be affected. In addition, no payment on account of principal (or premium, if any), interest or sinking fund, if any, may be made on such subordinated debt securities at any time
unless full payment of all amounts due in respect of the principal (and premium, if any), interest and sinking fund, if any, on Senior Indebtedness has been made or duly provided for in money or
money's worth.
In
the event that, notwithstanding the foregoing, any payment from us is received by the trustee in respect of subordinated debt securities or by the holders of any of such subordinated
debt securities before all Senior Indebtedness is paid in full, the payment or distribution must be paid over to the holders of the Senior Indebtedness or on their behalf for application to the
payment of all the Senior Indebtedness remaining unpaid until all the Senior Indebtedness has been paid in full, after giving effect to any concurrent payment or distribution to the holders of the
Senior Indebtedness. Subject to the payment in full of all Senior Indebtedness, the holders of such subordinated debt securities will be subrogated to the rights of the holders of the Senior
Indebtedness to the extent of payments made to the holders of the Senior Indebtedness out of the distributive share of such subordinated debt securities.
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By
reason of this subordination, in the event of a distribution of our assets upon our insolvency, certain of our senior creditors may recover more, ratably, than holders of any
subordinated debt securities. The related indenture will provide that these subordination provisions will not apply to money and securities held in trust under the defeasance provisions of the
indenture.
"Senior
Indebtedness" will be defined in an applicable indenture as the principal of (and premium, if any) and unpaid interest on:
-
-
our indebtedness (including indebtedness of others guaranteed by us), whenever created, incurred, assumed or guaranteed, for money borrowed
(other than indenture securities issued under the indenture and denominated as subordinated debt securities), unless in the instrument creating or evidencing the same or under which the same is
outstanding it is provided that this indebtedness is not senior or prior in right of payment to the subordinated debt securities; and
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renewals, extensions, modifications and refinancings of any of such indebtedness.
The
prospectus supplement accompanying any series of indenture securities denominated as subordinated debt securities will set forth the approximate amount of our Senior Indebtedness
outstanding as of a recent date.
Trustee
We intend to name the indenture trustee for each series of indenture securities in the related prospectus supplement.
Certain Considerations Relating to Foreign Currencies
Debt securities denominated or payable in foreign currencies may entail significant risks. These risks include the possibility of significant
fluctuations in the foreign currency markets, the imposition or modification of foreign exchange controls and potential illiquidity in the secondary market. These risks will vary depending upon the
currency or currencies involved and will be more fully described in the applicable prospectus supplement.
DESCRIPTION OF RIGHTS
The following is a general description of the terms of the rights we may issue from time to time unless we provide otherwise in the applicable
prospectus supplement. Particular terms of any rights we offer will be described in the prospectus supplement relating to such rights.
General
We may issue rights to purchase common stock, preferred stock, debt securities or units. Rights may be issued independently or together with
other securities and may or may not be transferable by the person purchasing or receiving the rights. In connection with any rights offering to our stockholders, we may enter into a standby
underwriting, backstop or other arrangement with one or more underwriters or other persons pursuant to which such underwriters or other persons would purchase any offered securities remaining
unsubscribed for after such rights offering. In connection with a rights offering to our stockholders, we would distribute certificates evidencing the rights and a prospectus supplement to our
stockholders on or about the record date that we set for receiving rights in such rights offering.
The
applicable prospectus supplement will describe the following terms of any rights we may issue, including some or all of the following:
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-
the title and aggregate number of the rights;
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-
-
the subscription price or a formula for the determination of the subscription price for the rights and the currency or currencies in which the
subscription price may be payable;
-
-
if applicable, the designation and terms of the securities with which the rights are issued and the number of rights issued with each such
security or each principal amount of such security;
-
-
the number or a formula for the determination of the number of the rights issued to each stockholder;
-
-
the extent to which the rights are transferable;
-
-
in the case of rights to purchase debt securities, the principal amount of debt securities purchasable upon exercise of one right;
-
-
in the case of rights to purchase common stock or preferred stock, the type of stock and number of shares of stock purchasable upon exercise of
one right;
-
-
the date on which the right to exercise the rights will commence, and the date on which the rights will expire (subject to any extension);
-
-
if applicable, the minimum or maximum amount of the rights that may be exercised at any one time;
-
-
the extent to which such rights include an over-subscription privilege with respect to unsubscribed securities;
-
-
if applicable, the procedures for adjusting the subscription price and number of shares of common stock or preferred stock purchasable upon the
exercise of each right upon the occurrence of certain events, including stock splits, reverse stock splits, combinations, subdivisions or reclassifications of common stock or preferred stock;
-
-
the effect on the rights of any merger, consolidation, sale or other disposition of our business;
-
-
the terms of any rights to redeem or call the rights;
-
-
information with respect to book-entry procedures, if any;
-
-
the terms of the securities issuable upon exercise of the rights;
-
-
if applicable, the material terms of any standby underwriting, backstop or other purchase arrangement that we may enter into in connection with
the rights offering;
-
-
if applicable, a discussion of certain U.S. Federal income tax considerations; and
-
-
any other terms of the rights, including terms, procedures and limitations relating to the exchange and exercise of the rights.
Exercise of Rights
Each right will entitle the holder to purchase for cash or other consideration such shares of stock or principal amount of securities at the
subscription price as shall in each case be set forth in, or be determinable as set forth in, the prospectus supplement relating to the rights offered thereby. Rights may be exercised as set forth in
the applicable prospectus supplement beginning on the date specified therein and continuing until the close of business on the expiration date set forth in the prospectus supplement relating to the
rights offered thereby. After the close of business on the expiration date, unexercised rights will become void.
Upon
receipt of payment and a subscription certificate properly completed and duly executed at the corporate trust office of the subscription agent or any other office indicated in the
prospectus supplement, we will, as soon as practicable, forward the securities purchasable upon such exercise. If
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less
than all of the rights represented by such subscription certificate are exercised, a new subscription certificate will be issued for the remaining rights. If we so indicate in the applicable
prospectus supplement, holders of the rights may surrender securities as all or part of the exercise price for rights.
We
may determine to offer any unsubscribed offered securities directly to stockholders, persons other than stockholders, to or through agents, underwriters or dealers or through a
combination of such methods, including pursuant to standby underwriting, backstop or other arrangements, as set forth in the applicable prospectus supplement.
Prior
to exercising their rights, holders of rights will not have any of the rights of holders of the securities purchasable upon subscription, including, in the case of rights to
purchase common stock or preferred stock, the right to receive dividends, if any, or payments upon our liquidation, dissolution or winding up or to exercise any voting rights or, in the case of rights
to purchase debt securities, the right to receive principal, premium, if any, or interest payments, on the debt securities purchasable upon exercise or to enforce covenants in the applicable
indenture.
DESCRIPTION OF UNITS
We may issue units comprising one or more securities described in this prospectus in any combination. The following description sets forth
certain general terms and provisions of the units that we may offer pursuant to this prospectus. The particular terms of the units and the extent, if any, to which the general terms and provisions may
apply to the units so offered will be described in the applicable prospectus supplement.
Each
unit will be issued so that the holder of the unit also is the holder of each security included in the unit. Thus, the unit will have the rights and obligations of a holder of each
included security. Units will be issued pursuant to the terms of a unit agreement, which may provide that the securities included in the unit may not be held or transferred separately at any time or
at any time before a specified date. A copy of the forms of the unit agreement and the unit certificate relating to any particular issue of units will be filed with the SEC each time we issue units,
and you should read those documents for provisions that may be important to you. For more information on how you can obtain copies of the forms of the unit agreement and the related unit certificate,
see "Where You Can Find More Information."
The
prospectus supplement relating to any particular issuance of units will describe the terms of those units, including, to the extent applicable, the
following:
-
-
the designation and terms of the units and the securities comprising the units, including whether and under what circumstances those securities
may be held or transferred separately;
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-
any provision for the issuance, payment, settlement, transfer or exchange of the units or of the securities comprising the units; and
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-
whether the units will be issued in fully registered or global form.
PLAN OF DISTRIBUTION
We may sell the securities offered by this prospectus in any one or more of the following ways from time to
time:
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-
to or through one or more underwriters, initial purchasers, brokers or dealers;
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through agents to investors or the public;
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in short or long transactions;
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through put or call option transactions relating to our common stock;
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directly to agents or other purchasers;
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in "at the market offerings" within the meaning of Rule 415(a)(4) of the Securities Act, to or through a market maker or into an
existing trading market, on an exchange or otherwise;
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-
though a combination of any such methods of sale; or
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-
through any other method described in the applicable prospectus supplement.
The
applicable prospectus supplement will set forth the terms of the offering and the method of distribution and will identify any firms acting as underwriters, initial purchasers,
dealers or agents in connection with the offering, including:
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-
the terms of the offering;
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-
the names of any underwriters, dealers or agents;
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-
the name or names of any managing underwriter or underwriters;
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the purchase price of the securities and the proceeds to us from the sale;
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any over-allotment options under which the underwriters may purchase additional shares of common stock from us;
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any underwriting discounts, concessions, commissions or agency fees and other items constituting compensation to underwriters, dealers or
agents;
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any delayed delivery arrangements;
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any public offering price;
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any discounts or concessions allowed or re-allowed or paid by underwriters or dealers to other dealers; or
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any securities exchange or market on which the common stock offered in the prospectus supplement may be listed.
If
we use underwriters for a sale of securities, the underwriters will acquire the securities for their own account for resale to the public, either on a firm commitment basis or a best
efforts basis. The underwriters may resell the securities in one or more transactions, including negotiated transactions, at a fixed public offering price or at varying prices determined at the time
of sale. Underwriters may offer the securities to the public either through underwriting syndicates represented by one or more managing underwriters or directly by one or more firms acting as
underwriters. If an underwriter or underwriters are used in the sale of securities hereunder, an underwriting agreement will be executed with the underwriter or underwriters at the time an agreement
for sale is reached. Unless we inform you otherwise in the applicable prospectus supplement, the obligations of the underwriters to purchase the securities will be subject to certain conditions. We
may change from time to time any public offering price and any discounts or concessions the underwriters allow or pay to dealers.
During
and after an offering through underwriters, the underwriters may purchase and sell the securities in the open market. These transactions may include overallotment and stabilizing
transactions and purchases to cover syndicate short positions created in connection with the offering. The underwriters may also impose a penalty bid, which means that selling concessions allowed to
syndicate members or other broker-dealers for the offered securities sold for their account may be reclaimed by the syndicate if the offered securities are repurchased by the syndicate in stabilizing
or covering transactions. These activities may stabilize, maintain or otherwise affect the market price of the offered securities, which may be higher than the price that might otherwise prevail in
the open market. If commenced, the underwriters may discontinue these activities at any time.
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Some
or all of the securities that we offer though this prospectus may be new issues of securities with no established trading market. Any underwriters to whom we sell our securities for
public offering and sale may make a market in those securities, but they will not be obligated to do so and they may discontinue any market making at any time without notice. Accordingly, we cannot
assure you of the liquidity of, or continued trading markets for, any securities that we offer.
If
dealers are used for the sale of securities, we, or an underwriter, will sell the securities to them as principals. The dealers may then resell those securities to the public at
varying prices determined by the dealers at the time of resale. We will include in the applicable prospectus supplement the names of the dealers and the terms of the transaction.
We
may also sell the securities through agents designated from time to time. In the applicable prospectus supplement, we will name any agent involved in the offer or sale of the offered
securities, and we will describe any commissions payable to the agent. Unless we inform you otherwise in the applicable prospectus supplement, any agent will agree to use its reasonable best efforts
to solicit purchases for the period of its appointment.
We
may sell the securities directly in transactions not involving underwriters, dealers or agents.
We
may sell the securities directly to institutional investors or others who may be deemed to be underwriters within the meaning of the Securities Act with respect to any sale of those
securities. We will describe the terms of any such sales in the prospectus supplement.
Underwriters,
dealers and agents that participate in the distribution of the securities may be underwriters as defined in the applicable securities laws and any discounts or commissions
they receive from us and any profit on their resale of the securities may be treated as underwriting discounts and commissions under the applicable securities laws. We will identify in the applicable
prospectus supplement any underwriters, dealers or agents and will describe their compensation. We may have agreements with the underwriters, dealers and agents to indemnify them against specified
civil liabilities, including liabilities under the applicable securities laws.
Underwriters,
dealers and agents may engage in transactions with or perform services for us in the ordinary course of their businesses for which they may receive customary fees and
reimbursement of expenses.
We
may use underwriters with whom we have a material relationship. We will describe the nature of such relationship in the applicable prospectus supplement.
Under
the securities laws of some states, the securities offered by this prospectus may be sold in those states only through registered or licensed brokers or dealers.
We
may enter into hedging transactions with broker-dealers and the broker-dealers may engage in short sales of the securities in the course of hedging the positions they assume with us,
including, without limitation, in connection with distributions of the securities by those broker-dealers. We may enter into option or other transactions with broker-dealers that involve the delivery
of the securities offered hereby to the broker-dealers, who may then resell or otherwise transfer those securities. We may also loan or pledge the securities offered hereby to a broker-dealer and the
broker-dealer may sell the securities offered hereby so loaned or upon a default may sell or otherwise transfer the pledged securities offered hereby.
LEGAL MATTERS
The validity of the securities being offered hereby will be passed upon for us by Morgan, Lewis & Bockius LLP, Princeton, New
Jersey.
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EXPERTS
Ernst & Young LLP, independent registered public accounting firm, has audited our financial statements included in our Annual
Report on Form 10-K for the year ended December 31, 2014, as set forth in their report, which is incorporated by reference in this prospectus and elsewhere in the registration statement.
Our financial statements are incorporated by reference in reliance on Ernst & Young LLP's report, given on their authority as experts in accounting and auditing.
WHERE YOU CAN FIND MORE INFORMATION
We file annual, quarterly and other reports, proxy and information statements and other information with the Securities and Exchange Commission.
Copies of these materials may be inspected and copied at the public reference facilities maintained by the SEC at 100 F Street, N.E., Washington, D.C. 20549. Please call the SEC at
1-800-SEC-0330 for further information on the operation of its public reference room. The SEC maintains a website that contains reports, proxy statements and other information regarding us. The
address of the SEC website is http://www.sec.gov. We maintain a website at www.agiletherapeutics.com. Information contained on our website is not incorporated into this prospectus and you should not
consider information contained on our website to be part of this prospectus or any prospectus supplement.
INFORMATION INCORPORATED BY REFERENCE
The SEC allows us to "incorporate by reference" into this prospectus the information contained in documents that we file with them, which means
that we can disclose important information to you by referring you to those documents. The information incorporated by reference is considered to be part of this prospectus. Information in this
prospectus supersedes information incorporated by reference that we filed with the SEC before the date of this prospectus, while information that we file later with the SEC will automatically update
and supersede prior information. Any information so updated and superseded shall not be deemed, except as so updated and superseded, to constitute a part of this prospectus. We incorporate by
reference the documents listed below and any future filings we will make with the SEC under Sections 13(a), 13(c), 14 or 15(d) of the Securities Exchange Act of 1934, as amended, prior to the
termination of the offering. Notwithstanding the foregoing, unless specifically stated to the contrary, none of the information that is not deemed "filed" with the SEC, including information furnished
under Items 2.02 or 7.01 of any Current Report on Form 8-K, will be incorporated by reference into, or otherwise included in, this prospectus:
-
1.
-
our
annual report on Form 10-K for the fiscal year ended December 31, 2014 filed with the SEC on March 16, 2015 (the "Form 10-K");
-
2.
-
the
information contained in our definitive proxy statement on Schedule 14A for our 2015 annual meeting of stockholders filed with the SEC on April 29,
2015, to the extent incorporated by reference in Part III of the Form 10-K;
-
3.
-
our
quarterly report on Form 10-Q for the quarter ended March 31, 2015 filed with the SEC on May 12, 2015;
-
4.
-
our
current reports on Form 8-K filed with the SEC on January 23, 2015, February 24, 2015 and June 10, 2015; and
-
5.
-
our
description of our common stock contained in the registration statement on Form 8-A, filed on May 20, 2014, and all amendments and reports updating
such description..
We
make available, free of charge, through our website our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and amendments to
those reports filed or furnished pursuant to Section 13(a), 13(c), 14 or 15(d) of the Exchange Act as soon as reasonably
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practicable
after we electronically file such material with, or furnish it to, the SEC. You may also obtain, free of charge, a copy of any of these documents (other than exhibits to these documents
unless the exhibits are specifically incorporated by reference into these documents or referred to in this prospectus) by writing or calling us at the following address and telephone number:
Agile
Therapeutics, Inc.
101 Poor Farm Road
Princeton, NJ 08540
(609) 683-1880
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Shares
Common Stock
Preliminary Prospectus Supplement
, 2017
Joint Book-Running Managers
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|
|
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William Blair
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RBC Capital Markets
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Cantor Fitzgerald & Co.
|
Until ,
2017, all dealers that buy, sell or trade the common stock may be required to deliver a prospectus, regardless of whether they are participating in this offering.
This is in addition to the dealers' obligation to deliver a prospectus when acting as underwriters and with respect to their unsold allotments or subscriptions.
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