Delaware | 94-3171943 | |
(State or Other Jurisdiction of Incorporation) | (I.R.S. Employer Identification Number) | |
2600 Kelly Road | ||
Warrington, Pennsylvania 18976 |
Title of Securities to be Registered | Amount to be Registered(1) | Proposed Maximum Offering Price Per Share(1)(2) | Proposed Maximum Aggregate Offering Price(2) | Amount of Registration Fee(1)(2) |
common stock, $.001 par value | 850,000 | $8.49 | $7,212,250 | $848.88 |
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TABLE OF CONTENTS | ii |
ABOUT THIS PROSPECTUS | 1 |
COMPANY SUMMARY | 1 |
CORPORATE INFORMATION | 10 |
RISK FACTORS | 10 |
FORWARD-LOOKING STATEMENTS | 27 |
USE OF PROCEEDS | 28 |
SELLING STOCKHOLDER | 28 |
PLAN OF DISTRIBUTION | 29 |
INTERESTS OF NAMED EXPERTS AND COUNSEL | 31 |
WHERE YOU CAN FIND MORE INFORMATION | 31 |
INFORMATION INCORPORATED BY REFERENCE | 32 |
EXPERTS | 33 |
LEGAL MATTERS | 33 |
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— | full retention of the surface-tension lowering properties of a functioning surfactant necessary to restore lung function and maintain patency of the conducting airways; |
— | full retention of the surfactant composition upon aerosolization; |
— | drug particle size suitable for deposition in the deep-lungs; |
— | delivery rates to achieve therapeutic dosages in a reasonable time period; and |
— | reproducible aerosol output and minimal waste of surfactant dose. |
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— | the number of clinical sites; |
— | the size of the patient population; |
— | the proximity of patients to the clinical sites; |
— | the eligibility criteria for the study; |
— | the existence of competing clinical trials; and |
— | the existence of alternative available products. |
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— | defend our patents and otherwise prevent others from infringing on our proprietary rights; |
— | protect trade secrets; and |
— | operate without infringing upon the proprietary rights of others, both in the United States and in other countries. |
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— | they will breach these agreements; |
— | any agreements we obtain will not provide adequate remedies for the applicable type of breach or that our trade secrets or proprietary know-how will otherwise become known or competitors will independently develop similar technology; and |
— | our competitors will independently discover our proprietary information and trade secrets. |
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— | we may be required to relinquish important rights to our products or product candidates; |
— | we may not be able to control the amount and timing of resources that our distributors or collaborators may devote to the commercialization of our product candidates; |
— | our distributors or collaborators may experience financial difficulties; |
— | our distributors or collaborators may not devote sufficient time to the marketing and sales of our products thereby exposing us to potential expenses in terminating such distribution agreements; and |
— | business combinations or significant changes in a collaborator’s business strategy may also adversely affect a collaborator’s willingness or ability to complete its obligations under any arrangement. |
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— | developing products; |
— | undertaking preclinical testing and human clinical trials; |
— | obtaining FDA and other regulatory approvals or products; and |
— | manufacturing and marketing products. |
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— | announcements of the results of clinical trials by us or our competitors; |
— | adverse reactions to products; |
— | governmental approvals, delays in expected governmental approvals or withdrawals of any prior governmental approvals or public or regulatory agency concerns regarding the safety or effectiveness of our products; |
— | changes in the United States or foreign regulatory policy during the period of product development; |
— | developments in patent or other proprietary rights, including any third party challenge of our intellectual property rights; |
— | announcements of technological innovations by us or our competitors; |
— | announcements of new products or new contracts by us or our competitors; |
— | actual or anticipated variations in our operating results due to the level of development expenses and other factors; |
— | changes in financial estimates by securities analysts and whether our earnings meet or exceed the estimates; |
— | conditions and trends in the pharmaceutical and other industries; |
— | new accounting standards; and |
— | the occurrence of any of the risks described in these Risk Factors. |
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Name | Number of Shares of Common Stock, not including shares represented by Warrants, Beneficially Owned | Number of Shares Represented by Warrants Beneficially Owned | Total Number of Shares of Common Stock Beneficially Owned(1) | Percentage Beneficially Owned Before Offering(1) | Number of Shares to be Offered for the Account of the Selling Stockholder | Number of Shares to be Owned after this Offering, including shares represented by Warrants(1) | Percentage to be Beneficially Owned after this Offering(1) | |||||||||||||||
QFinance, Inc. | 1,567,741 | 893,612 | 2,461,353 | 5.08 | % | 850,000 | 1,611,353 | 3.33 | % | |||||||||||||
* Less than 1%. |
(1) | The number of shares of common stock beneficially owned by the selling stockholder prior to the offering is deemed to include the 893,612 shares of common stock issuable upon the exercise of warrants held by such selling stockholder, 850,000 of which are being registered hereunder. The 850,000 shares of common stock are issuable upon exercise of a warrant which has a 10-year term and is exercisable upon the earlier to occur of FDA approval of Surfaxin for RDS or Meconium Aspiration Syndrome, on the one hand and May 2, 2005, on the other hand. The number of shares of common stock beneficially owned by the selling stockholder after the offering is deemed to include the 43,612 shares of common stock issuable upon the exercise of a warrant held by such selling stockholder, none of which are being registered hereunder. |
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-- | in a block trade in which a broker-dealer will attempt to sell a block of shares as agent but may position and resell a portion of the block as principal to facilitate the transaction; |
-- | purchases by a broker-dealer as principal and resale by that broker-dealer for its account pursuant to this prospectus; |
-- | on markets where our common stock is traded or in an exchange distribution in accordance with the rules of the exchange; |
-- | through broker-dealers, that may act as agents or principals; |
-- | directly to one or more purchasers; |
-- | through agents; |
-- | in connection with the loan or pledge of shares to a broker-dealer, and the sale of the shares so loaned or the sale of the shares so pledged upon a default; |
-- | in connection with put or call option transactions, in hedge transactions and in settlement of other transactions in standardized or over-the-counter options; |
-- | through short sales of the shares by the selling stockholder or counterparties to those transactions, in privately negotiated transactions; or |
-- | in any combination of the above. In addition, any of the shares that qualify for sale pursuant to Rule 144 under the Securities Act of 1933 may be sold under Rule 144 rather than pursuant to this prospectus provided they meet the criteria and conform to the requirements of such Rule. |
-- | purchases of the shares by a broker-dealer as principal and resales of the shares by the broker-dealer for its account pursuant to this prospectus; |
-- | ordinary brokerage transactions; or |
-- | transactions in which the broker-dealer solicits purchasers. |
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1. | Our Annual Report on Form 10-K for the fiscal year ended December 31, 2003; |
2. | Our Quarterly Reports on Form 10-Q for the fiscal quarters ended March 31, 2004, June 30, 2004, and September 30, 2004; |
3. | Our Current Reports on Form 8-K filed with the Securities and Exchange Commission on February 6, 2004, February 19, 2004, March 30, 2004, May 10, 2004, June 15, 2004, June 30, 2004, July 9, 2004, August 5, 2004, September 20, 2004, October 28, 2004, November 4, 2004 and December 9, 2004; and |
4. | The description of our capital stock contained in our Registration Statements on Form 8-A filed with the Securities and Exchange Commission on July 13, 1995, and February 6, 2004. |
5. | All documents we have filed with the Securities and Exchange Commission pursuant to Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act after the date of the initial registration statement and prior to the effectiveness of the registration statement, as well as subsequent to the date of this prospectus and prior to the termination of this offering, shall be deemed to be incorporated by reference into this prospectus and to be a part of this prospectus from the date of the filing of the documents. |
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Amount | ||||
Securities and Exchange Commission registration fee | $ | 848.88 | ||
Accounting fees and expenses | $ | 7,500.00 | ||
Legal fees and expenses | $ | 25,000.00 | ||
Miscellaneous fees and expenses | $ | 1,651.12 | ||
Total | $ | 35,000.00 | ||
3.1 | Restated Certificate of Incorporation of Discovery, dated September 18, 2002. |
3.2 | Certificate of Amendment to the Certificate of Incorporation, dated May 28, 2004. |
3.3 | Amended and Restated Bylaws of Discovery, dated December 12, 2003. |
3.4 | Shareholder Rights Agreement, dated as of February 6, 2004, by and between Discovery and Continental Stock Transfer & Trust Company. |
5.1 | Opinion of Dickstein Shapiro Morin & Oshinsky LLP, legal counsel. |
23.1 | Consent of Ernst & Young LLP, independent registered public accounting firm. |
23.2 | Consent of Dickstein Shapiro Morin & Oshinsky LLP, legal counsel (included in Exhibit 5.1). |
24.1 | Powers of Attorney (included in Signature Pages to this Registration Statement on Form S-3). |
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DISCOVERY LABORATORIES, INC. (Registrant) | ||
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By: | /s/ Robert J. Capetola | |
Robert J. Capetola, Ph.D. President and Chief Executive Officer |
II-4 | ||
Signature | Name & Title | Date |
/s/ Robert J. Capetola | Robert J. Capetola, Ph.D. | December 15, 2004 |
President, Chief Executive Officer and Director | ||
/s/ John G. Cooper | John G. Cooper | December 15, 2004 |
Executive Vice President and Chief Financial Officer | ||
/s/ Cynthia Davis | Cynthia Davis | December 15, 2004 |
Controller and Principal Accounting Officer | ||
/s/ Herbert McDade | Herbert McDade, Jr. | December 15, 2004 |
Chairman of the Board of Directors | ||
/s/ W. Thomas Amick | W. Thomas Amick | December 15, 2004 |
Director | ||
/s/ Antonio Esteve | Antonio Esteve, Ph.D. | December 15, 2004 |
Director | ||
/s/ Max Link | Max Link, Ph.D. | December 15, 2004 |
Director | ||
/s/ Marvin E. Rosenthale | Marvin E. Rosenthale, Ph.D. | December 15, 2004 |
Director |
II-5 | ||
Exhibit No. | Description |
3.1(1) | Restated Certificate of Incorporation of Discovery, dated September 18, 2002. |
3.2(2) | Certificate of Amendment to the Certificate of Incorporation, dated May 28, 2004. |
3.3(3) | Amended and Restated Bylaws of Discovery, dated December 12, 2003. |
3.4(4) | Shareholder Rights Agreement, dated as of February 6, 2004, by and between Discovery and Continental Stock Transfer & Trust Company. |
5.1 | Opinion of Dickstein Shapiro Morin & Oshinsky LLP, legal counsel.* |
23.1 | Consent of Ernst & Young LLP, independent registered public accounting firm.* |
23.2 | Consent of Dickstein Shapiro Morin & Oshinsky LLP, legal counsel (included in Exhibit 5.1).* |
24.1 | Powers of Attorney (included in Signatures Page to this Registration Statement on Form S-3).* |
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