SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K/A
CURRENT REPORT
Current Report Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
February 27, 2004
(Amending report originally dated November 12, 2003
and amended January 12, 2004)
GUILFORD PHARMACEUTICALS INC.
(Exact name of registrant as specified in its
charter)
| | | | |
Delaware | | 0-23736 | | 52-1841960 |
|
(State or other jurisdiction of | | (Commission File Number) | | (I.R.S. Employer |
incorporation or organization) | | | | Identification No.) |
| | |
6611 Tributary Street | | |
Baltimore, Maryland | | 21224 |
|
(Address of principal executive offices) | | (Zip Code) |
Registrant’s telephone number, including area code: (410) 631-6300
(Former name or former address, if changed since last report)
Exhibit Index is on page 10.
INFORMATION TO BE INCLUDED IN THE REPORT
Item 7.Financial Statements, Pro Forma Financial Information and Exhibits
On November 12, 2003, the Company filed a current report on Form 8-K (the “Original Report”) regarding its October 28, 2003, acquisition of the rights to AGGRASTAT® Injection (“AGGRASTAT®”), from Merck and Co., Inc., in the United States and its territories and possessions which include Puerto Rico, the U.S. Virgin Islands and Guam. On January 12, 2004, the Company filed a report on Form 8-K/A (the “First Amendment”) to amend and supplement Item 7 of the Original Report to include certain financial information required by Items 7(a) and (b) of Form 8-K. The Company is filing this report amending Item 7(b) of Form 8-K/A to eliminate the liability for the net present value of royalties owed to Merck and Co., Inc. on future sales of AGGRASTAT® and associated interest expense contained in the pro forma financial information.
| | |
(b) | | Pro forma financial information, as amended |
| | |
| | Unaudited Pro Forma Condensed Balance Sheet as of September 30, 2003 of Guilford Pharmaceuticals Inc. |
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| | Unaudited Pro Forma Condensed Statement of Operations for the Nine Months Ended September 30, 2003 of Guilford Pharmaceuticals Inc. |
| | |
| | Unaudited Pro Forma Condensed Statement of Operations for the Year Ended December 31, 2002 of Guilford Pharmaceuticals Inc. |
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(c) | | Exhibits |
| | |
| | 23.01 Consent of Eisner LLP |
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GUILFORD PHARMACEUTICALS INC.
AND SUBSIDIARIES
PRO FORMA FINANCIAL INFORMATION (UNAUDITED)
The following unaudited pro forma condensed statements of operations for the nine months ended September 30, 2003 and for the year ended December 31, 2002, give the effect to the acquisition of AGGRASTAT® Injection (“AGGRASTAT®”) product rights as if such acquisition had occurred at the beginning of the respective periods. The following unaudited pro forma condensed balance sheet as of September 30, 2003, gives effect to the AGGRASTAT® product rights acquisition as if it had occurred on September 30, 2003.
The pro forma adjustments are based upon available information and certain assumptions that management believes are reasonable under the circumstances. The pro forma adjustments were applied to the respective historical financial statements to reflect and account for the acquisition using the purchase method of accounting. The pro forma statement of operations excludes material non-recurring charges of $8.1 million related to acquired in-process research and development. The pro forma financial information is not necessarily indicative of the operating results or financial position that would have been achieved had the acquisition been consummated on the dates indicated and should not be construed as representative of future operating results or financial position. Specifically, Guilford Pharmaceuticals Inc. (“the Company”) expects to incur additional selling expenses related to its promotional efforts for the acquisition on an ongoing basis, in addition to up-front costs expected to be incurred related to the initial launch of this product. The purchase price was allocated to intangible assets acquired based on their respective fair values as determined in a valuation study performed by a third party and management’s evaluation of the assets and liabilities. The purchase price allocation among the intangible assets acquired and the assignment of lives of these intangible assets are subject to change based upon further evaluation.
The unaudited pro forma condensed financial statements should be read in conjunction with the Company’s Consolidated Financial Statements and related Notes thereto, Management’s Discussion and Analysis of Financial Condition and Results of Operations included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2002 and the Quarterly Report on form 10-Q for the quarter ended September 30, 2003.
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GUILFORD PHARMACEUTICALS INC.
AND SUBSIDIARIES
Unaudited Pro Forma Condensed Balance Sheet
As of September 30, 2003
(in thousands)
| | | | | | | | | | | | | | | | | | | | | | | |
| | | | |
| | | | | | | | | | | | | |
| | | | | Guilford | | | | | | Pro Forma | | |
| | | | | Pharmaceuticals Inc. | | | | | | Adjustments | | Pro Forma |
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|
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Current assets: | | | | | | | | | | | | | | | | | | | | |
| Cash, cash equivalents and investments, net | | | | | | $ | 110,834 | | | | | | | $ | (45,990 | ) (a) | | $ | 64,844 | |
| Accounts receivable, net | | | | | | | 771 | | | | | | | | — | | | | 771 | |
| Inventories, net | | | | | | | 2,166 | | | | | | | | — | | | | 2,166 | |
| Prepaid expenses and other current assets | | | | | | | 2,154 | | | | | | | | — | | | | 2,154 | |
| | | | | | | |
| | | | | | | |
| | | |
| |
| | | Total current assets | | | | | | | 115,925 | | | | | | | | (45,990 | ) | | | 69,935 | |
Investments – restricted | | | | | | | 22,021 | | | | | | | | — | | | | 22,021 | |
Property and equipment, net | | | | | | | 23,216 | | | | | | | | — | | | | 23,216 | |
Intangible assets and other assets, net | | | | | | | 10,514 | | | | | | | | 79,896 | (b) | | | 90,410 | |
| | | | | | | |
| | | | | | | |
| | | |
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| | | | | | $ | 171,676 | | | | | | | $ | 33,906 | | | $ | 205,582 | |
| | | | | | | |
| | | | | | | |
| | | |
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| | LIABILITIES AND STOCKHOLDERS’ EQUITY | | | | |
Current liabilities: | | | | | | | | | | | | | | | | | | | | |
| Accounts payable | | | | | | $ | 4,947 | | | | | | | $ | — | | | $ | 4,947 | |
| Current portion of long-term debt | | | | | | | 3,651 | | | | | | | | — | | | | 3,651 | |
| Accrued expenses and other current liabilities | | | | | | | 8,081 | | | | | | | | — | | | | 8,081 | |
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| | | | | | | |
| | | |
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| Total current liabilities | | | | | | | 16,679 | | | | | | | | — | | | | 16,679 | |
Long-term debt, net of current portion | | | | | | | 89,352 | | | | | | | | — | | | | 89,352 | |
Other liabilities | | | | | | | 1,386 | | | | | | | | — | | | | 1,386 | |
Revenue interest obligation | | | | | | | — | | | | | | | | 40,774 | (c) | | | 40,774 | |
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| | | | | | | |
| | | |
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| | | Total liabilities | | | | | | | 107,417 | | | | | | | | 40,774 | | | | 148,191 | |
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| | | Stockholders’ equity | | | | | | | 64,259 | | | | | | | | (6,868 | ) (d) | | | 57,391 | |
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| | | | | | $ | 171,676 | | | | | | | $ | 33,906 | | | $ | 205,582 | |
| | | | | | | |
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The accompanying notes are an integral part of this unaudited pro forma condensed balance sheet.
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GUILFORD PHARMACEUTICALS INC.
AND SUBSIDIARIES
Unaudited Pro Forma Condensed Statement of Operations
For the Nine Months Ended September 30, 2003
(in thousands, except per share data)
| | | | | | | | | | | | | | | | | | | | | | |
| | | | Guilford | | Aggrastat | | Pro Forma | | |
| | | | Pharmaceuticals Inc. | | Product Line | | Adjustments | | Pro Forma |
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Revenues: | | | | | | | | | | | | | | | | | | | | |
| Net product sales | | $ | 13,708 | | | $ | 18,392 | | | | — | | | | | | | $ | 32,100 | |
| Revenues from license fees and milestones | | | 5,777 | | | | — | | | | — | | | | | | | | 5,777 | |
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| | Total revenues | | | 19,485 | | | | 18,392 | | | | — | | | | | | | | 37,877 | |
Costs and Expenses: | | | | | | | | | | | | | | | | | | | | |
| Cost of sales | | | 2,899 | | | | 857 | | | | — | | | | | | | | 3,756 | |
| Research and development | | | 24,253 | | | | — | | | | — | | | | | | | | 24,253 | |
| Selling, general and administrative | | | 22,250 | | | | 142 | | | | — | | | | | | | | 22,392 | |
| Intangible amortization | | | 630 | | | | — | | | | 4,509 | (e) | | | | | | | 5,139 | |
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| | | | | | | |
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| | Total costs and expenses | | | 50,032 | | | | 999 | | | | 4,509 | | | | | | | | 55,540 | |
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Operating income (loss) | | | (30,547 | ) | | | 17,393 | | | | (4,509 | ) | | | | | | | (17,663 | ) |
Other income (expense): | | | | | | | | | | | | | | | | | | | | |
| Investment income | | | 2,361 | | | | — | | | | — | | | | | | | | 2,361 | |
| Revenue interest expense | | | — | | | | — | | | | (7,126 | )(f) | | | | | | (7,126 | ) |
| Interest expense | | | (1,643 | ) | | | — | | | | — | | | | | | | (1,643 | ) |
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Net income (loss) | | $ | (29,829 | ) | | $ | 17,393 | | | $ | (11,635 | ) | | | | | | $ | (24,071 | ) |
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Basic and diluted loss per common share: | | $ | (1.01 | ) | | | — | | | | — | | | | | | | $ | (0.81 | ) |
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Weighted-average shares outstanding to compute basic and diluted loss per share | | | 29,541 | | | | — | | | | — | (g) | | | | | | | 29,541 | |
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The above unaudited pro forma condensed statement of operations excludes the impact of non-recurring charges of $8.1 million for Acquired in-process research and development.
The accompanying notes are an integral part of this unaudited pro forma condensed statement of operations.
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GUILFORD PHARMACEUTICALS INC.
AND SUBSIDIARIES
Unaudited Pro Forma Condensed Statement of Operations
For the Year Ended December 31, 2002
(in thousands, except per share data)
| | | | | | | | | | | | | | | | | | | | |
| | | | Guilford | | Aggrastat | | Pro Forma | | | | |
| | | | Pharmaceuticals Inc. | | Product Line | | Adjustments | | | | Pro Forma |
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Revenues: | | | | | | | | | | | | | | | | | | |
| Net product sales | | $ | 14,538 | | | $ | 54,764 | | | $ | — | | | | | $ | 69,302 | |
| Revenues from license fees and milestones | | | 127 | | | | — | | | | — | | | | | | 127 | |
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| | Total revenues | | | 14,665 | | | | 54,764 | | | | — | | | | | | 69,429 | |
Costs and Expenses: | | | | | | | | | | | | | | | | | | |
| Cost of sales | | | 2,836 | | | | 2,133 | | | | — | | | | | | 4,969 | |
| Research and development | | | 46,103 | | | | — | | | | — | | | | | | 46,103 | |
| Selling, general and administrative | | | 29,005 | | | | 16,636 | | | | — | | | | | | 45,641 | |
| Intangible amortization | | | 840 | | | | — | | | | 6,012 | | (e | ) | | | 6,852 | |
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| | Total costs and expenses | | | 78,784 | | | | 18,769 | | | | 6,012 | | | | | | 103,565 | |
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Operating income (loss) | | | (64,119 | ) | | | 35,995 | | | | (6,012 | ) | | | | | (34,136 | ) |
Other income (expense): | | | | | | | | | | | | | | | | | | |
| Investment income | | | 5,350 | | | | — | | | | — | | | | | | 5,350 | |
| Revenue interest expense | | | — | | | | — | | | | (9,501 | ) | (f | ) | | | (9,501 | ) |
| Interest expense | | | (501 | ) | | | — | | | | — | | | | | | (501 | ) |
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Net income (loss) | | $ | (59,270 | ) | | $ | 35,995 | | | $ | (15,513 | ) | | | | $ | (38,788 | ) |
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Basic and diluted loss per common share: | | $ | (1.99 | ) | | | — | | | | — | | | | | $ | (1.30 | ) |
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Weighted-average shares outstanding to compute basic and diluted loss per share | | | 29,805 | | | | — | | | | — | | (g | ) | | | 29,805 | |
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The above unaudited pro forma condensed statement of operations excludes the impact of non-recurring charges of $8.1 million for Acquired in-process research and development.
The accompanying notes are an integral part of this unaudited pro forma condensed statement of operations.
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GUILFORD PHARMACEUTICALS INC.
AND SUBSIDIARIES
Notes to Unaudited Pro Forma Condensed Balance Sheet and Statements of Operations
Following is a summary of the purchase price in millions:
| | | | |
Cash consideration, including $42.0 million received from a revenue | | | | |
interest financing arrangement entered into with Paul Royalty Fund, L.P. | | | | |
and certain of its affiliated entities, collectively known as “PRF” | | $ | 84.0 | |
Estimated transaction fees | | | 2.2 | |
| | |
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| | $ | 86.2 | |
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The allocation of the purchase price of the AGGRASTAT® Injection (“AGGRASTAT®”) acquisition is as follows:
| | | | |
Intangible assets | | $ | 78.1 | |
Acquired in-process research and development | | | 8.1 | |
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| | $ | 86.2 | |
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At the date of acquisition, the development of AGGRASTAT® for use in Percutaneous Coronary Intervention (“PCI”) was not complete, had not reached technological feasibility and had no known alternative future uses. Consequently, there is considerable uncertainty as to the technological feasibility of the product for this indication at the date of acquisition. The Company does not foresee any alternative future benefit from the acquired research and development other than specifically related to the PCI indication under development. Significant technological and regulatory approval risk are associated with the development of the product for a PCI indication. Achieving such an indication will require significant amounts of future time, effort, and substantial development costs, which will be incurred by the Company. The efforts required to develop the acquired research and development into commercially viable products include the completion of the clinical-trial testing, regulatory approval and commercialization. The principal risks relating to achieving the indication under development are the outcomes of clinical studies and regulatory filings. Since pharmaceutical products cannot be marketed without regulatory approvals, the Company will not receive any benefits unless regulatory approval is obtained. Accordingly, the portion of the purchase price related to these products under development was allocated to acquired in-process research and development and was expensed at the date of acquisition.
(a) | | Represents Guilford’s use of $42.0 million cash to finance the acquisition of the AGGRASTAT® product rights as well as approximately $4.0 million of costs related to the PRF financing of approximately $1.8 million and acquisition costs of $2.2 million noted above. |
(b) | | Represents the intangible assets acquired as part of the AGGRASTAT® acquisition ($78.1 million) plus deferred financing costs associated with the PRF revenue interest obligation ($1.8 million). |
(c) | | Represents the revenue interest sold to PRF ($42.0 million) net of the value allocated to the five year warrants to purchase 300,000 shares of the Company’s common stock at $9.15 per share. The allocation was determined based upon the relative fair values of the two financial instruments at the time of issuance. While the Company has minimum payments within one year of the balance sheet presented, the accretion of interest will exceed such payments and the revenue interest will increase during the earlier years of the relationship. |
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GUILFORD PHARMACEUTICALS INC.
AND SUBSIDIARIES
Notes to Unaudited Pro Forma Condensed Balance Sheet and Statements of Operations
| | |
(d) | | Represents the write-off of acquired in-process research and development ($8.1 million) net of the allocated value assigned to the warrants ($1.2 million) included as part of the PRF revenue interest obligation transaction. |
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(e) | | Represents the amortization of intangible assets acquired in connection with the acquisition based on the preliminary purchase price allocation over their estimated useful lives. |
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| | | | | | | | | | | For the nine months ended | | For the year ended |
| | | Fair Value of | | | | | | September 30, 2003 | | December 31, 2002 |
Intangible | | Intangibles | | Estimated Life | | Amortization | | Amortization |
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| | | | | | (in years) | | (dollars in millions) | | | | |
Patents (1) | | $ | 53.4 | | | | 13 | | | $ | 3.1 | | | $ | 4.1 | |
Trademarks (2) | | | 9.7 | | | | 13 | | | | 0.6 | | | | 0.8 | |
Customer contracts and related relationships (2) | | | 14.7 | | | | 13 | | | | 0.8 | | | | 1.1 | |
Other | | | 0.3 | | | | 11 | | | | 0.0 | | | | 0.0 | |
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| Total | | $ | 78.1 | | | | | | | $ | 4.5 | | | $ | 6.0 | |
(1) | | Certain core formulation patents that cover the product expire in 2016. |
(2) | | The expected lives of the intangible assets relate to the lives of the patents, and therefore have a consistent estimated life. |
(f) | | Represents effective interest expense related to the PRF revenue interest obligation and amortization of deferred financing costs associated with the acquisition. |
(g) | | The transaction was financed by cash, the long-term revenue interest obligation and associated warrants. As no common stock was issued and the Company has a pro forma loss, there is no pro forma impact on the weighted average shares outstanding or loss per share. |
Certain prior year amounts of Guilford Pharmaceuticals Inc. have been reclassified to conform with the current year presentation.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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| | | GUILFORD PHARMACEUTICALS INC. |
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Dated: | February 27, 2004 | By: | /s/ Andrew R. Jordan |
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| | | | Andrew R. Jordan Executive Vice President, Chief Financial Officer and Treasurer |
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INDEX TO EXHIBITS
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Exhibit | | |
Number | | Exhibit Description |
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23.01 | | Consent of Eisner LLP |
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