-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, MmIE9AnprcolKovGpq4VeB7jadZ+so8fNBLFzyNkimG4E9zkyR0sU40LNEpf8bSu NUFOs92Ze22Vy+DTc6JghQ== 0000892569-97-002292.txt : 19970815 0000892569-97-002292.hdr.sgml : 19970815 ACCESSION NUMBER: 0000892569-97-002292 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 19970630 FILED AS OF DATE: 19970814 SROS: NYSE FILER: COMPANY DATA: COMPANY CONFORMED NAME: ALLERGAN LIGAND RETINOID THERAPEUTICS INC CENTRAL INDEX KEY: 0000934592 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 330642614 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 000-25962 FILM NUMBER: 97662468 BUSINESS ADDRESS: STREET 1: 9393 TOWNE CENTER DR CITY: SAN DIEGO STATE: CA ZIP: 92121 BUSINESS PHONE: 6195353900 MAIL ADDRESS: STREET 1: 2525 DUPONT DR CITY: IRVINE STATE: CA ZIP: 92715 10-Q 1 FORM 10-Q FOR THE QUARTER ENDED JUNE 30, 1997 1 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q - -------------------------------------------------------------------------------- (Mark One) [X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 1997......................... OR [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. - -------------------------------------------------------------------------------- COMMISSION FILE NUMBER 0-25970 ALLERGAN LIGAND RETINOID THERAPEUTICS, INC. A DELAWARE CORPORATION IRS EMPLOYER IDENTIFICATION 33-0642614 2525 DUPONT DRIVE, IRVINE, CALIFORNIA 92612 TELEPHONE NUMBER 714/246-4500 Indicate by a check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. (1) X yes no ------ ------ (2) X yes no ------ ------ Indicate the number of shares outstanding of each of the issuer's classes of common stock as of the latest practicable date. As of July 31, 1997 there were 3,250,000 shares of callable common stock outstanding, and 200 shares of special common stock outstanding. Panretin(TM) is a trademark of ALRT. 1 2 ALLERGAN LIGAND RETINOID THERAPEUTICS, INC. FORM 10-Q FOR THE QUARTER ENDED JUNE 30, 1997 INDEX
Page PART I - FINANCIAL INFORMATION ITEM 1 - FINANCIAL STATEMENTS Statements of Operations - 3 Three and Six Months Ended June 30, 1997 and 1996 Condensed Balance Sheets at June 30, 1997 4 and December 31, 1996 Statements of Cash Flows - 5 Six Months Ended June 30, 1997 and 1996 Notes to Financial Statements 6-7 ITEM 2 - MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 8-20 PART II - OTHER INFORMATION ITEM 2 - CHANGES IN SECURITIES 21 ITEM 4 - SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS 21 ITEM 6 - EXHIBITS AND REPORTS ON FORM 8-K 21 Signature 22
2 3 PART I - FINANCIAL INFORMATION Allergan Ligand Retinoid Therapeutics, Inc. Statements of Operations (In thousands, except per share amounts)
Three Months Six Months Ended Ended ----- ----- June 30, June 30, 1997 1996 1997 1996 ---- ---- ---- ---- Revenues: Interest income $ 493 $ 1,133 $ 1,112 $ 2,088 Costs and expenses: Research and development 9,579 6,832 19,095 12,710 General and administrative expenses 466 435 770 788 -------- -------- -------- -------- Total costs and expenses 10,045 7,267 19,865 13,498 -------- -------- -------- -------- Net loss $(9,552) $ (6,134) $(18,753) $(11,410) ======== ======== ======== ======== Net loss per callable common share $ (2.94) $ (1.89) $ (5.77) $ (3.51) ======== ======== ======== ======== Weighted average callable common shares outstanding 3,250 3,250 3,250 3,250
See accompanying notes. 3 4 Allergan Ligand Retinoid Therapeutics, Inc. Condensed Balance Sheets (In thousands, except share data)
June 30, December 31, 1997 1996 -------- ------------ ASSETS Cash and cash equivalents $ 14,260 $ 29,897 Marketable securities 17,442 20,394 Other assets 616 720 -------- -------- $ 32,318 $ 51,011 ======== ======== LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Payable to Allergan, Inc. and Ligand Pharmaceuticals Incorporated $ 3,859 $ 3,889 Accounts payable and accrued liabilities 361 261 -------- -------- Total current liabilities 4,220 4,150 Stockholders' equity: Callable Common stock, $.001 par value; 3,250,000 shares authorized, issued and outstanding 3 3 Additional paid-in capital 94,256 94,256 Accumulated deficit (65,981) (47,228) Unrealized holding loss on marketable securities (180) (170) -------- -------- Total stockholders' equity 28,098 46,861 -------- -------- $ 32,318 $ 51,011 ======== ========
See accompanying notes. 4 5 Allergan Ligand Retinoid Therapeutics, Inc. Statements of Cash Flows (In thousands)
Six Months Ended ----- June 30, June 30, 1997 1996 ---- ---- OPERATING ACTIVITIES: Net loss $(18,753) $(11,410) Changes in operating assets and liabilities: Other assets 104 (770) Payable to Allergan, Inc. and Ligand Pharmaceuticals Incorporated (30) (416) Accounts payable and accrued liabilities 100 (533) -------- -------- Net cash used in operating activities (18,579) (13,129) INVESTING ACTIVITIES: Sale(purchase) of marketable securities 2,942 (24,064) -------- -------- Net decrease in cash and equivalents (15,637) (37,193) Cash and equivalents at beginning of period 29,897 79,793 -------- -------- Cash and equivalents at end of period $ 14,260 $ 42,600 ======== ========
See accompanying notes. 5 6 Allergan Ligand Retinoid Therapeutics, Inc. Notes to Financial Statements 1. Allergan Ligand Retinoid Therapeutics, Inc. (the Company) was incorporated in Delaware in 1994 and commenced operations on June 3, 1995 to continue the efforts of the Allergan Ligand Joint Venture (Joint Venture), established by Allergan, Inc. (Allergan) and Ligand Pharmaceuticals Incorporated (Ligand) in June 1992, to discover, develop and commercialize drugs based on retinoids. On June 3, 1995, the Company and Ligand completed a public offering (the Offering) of 3.25 million units (the Units), each Unit consisting of one share of the Company's callable common stock (Callable Common Stock) and two warrants (the Warrants), each to purchase one share of Ligand common stock. The Offering raised net proceeds for the Company of $26.8 million. At the completion of the Offering, Ligand contributed $17.5 million in cash, as well as warrants in exchange for (i) a right to acquire all of the Callable Common Stock at specified future dates and amounts and (ii) a right to acquire all rights to the Panretin (ALRT1057) product, jointly with Allergan, currently under development by the Company. At the same time, Allergan contributed $50.0 million in cash to the Company in exchange for (i) the right to acquire one-half of technologies and other assets in the event Ligand exercises its right to acquire all of the Callable Common Stock, (ii) a similar right to acquire all of the Callable Common Stock if Ligand does not exercise its right and (iii) a right to acquire all rights to the Panretin (ALRT1057) product, jointly with Ligand. On June 3, 1997, the Units separated and the Callable Common Stock and Warrants currently trade separately. ALRT's Board of Directors approved a research and development plan for the year ending December 31, 1997 which represents an acceleration in spending on ALRT's retinoid programs. The accelerated spending is the result of more rapid discovery and development of a significantly larger library of viable retinoid compounds than anticipated at the time of formation of ALRT. ALRT anticipates the acceleration in spending could result in the use of substantially all of the funds available for research and development remaining in ALRT in late 1997 or early 1998. Ligand and Allergan have certain purchase options over the Callable Common Stock and the assets of ALRT, the exercise of which could be triggered by the use of substantially all of ALRT's funds. There can be no assurance that Ligand or Allergan will exercise these options. 2. In the opinion of management, the accompanying unaudited financial statements contain all adjustments (consisting only of normal recurring accruals) necessary to present fairly the financial information contained therein. These statements do not include all disclosures required by generally accepted accounting principles. The results of operations for the quarter and six months ended June 30, 1997 are not necessarily indicative of the results to be expected for the year ending December 31, 1997. Net loss per callable common share is computed by dividing the net loss by the number of callable common shares outstanding, which was 3,250,000 at all times during the periods reported. 3. The Company invests its excess cash in money market funds and debt instruments of financial institutions and corporations with strong credit ratings. The Company has established guidelines with respect to the diversification and maturities in order to maintain safety and liquidity. 6 7 Allergan Ligand Retinoid Therapeutics, Inc. Notes to Financial Statements (continued) The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents. The Company's investments are classified as available-for-sale and are carried at fair value, with unrealized gains and losses reported as a separate component of stockholders' equity. The investments are adjusted for amortization of premiums and discounts to maturity and such amortization is included in interest income. 7 8 ALLERGAN LIGAND RETINOID THERAPEUTICS, INC. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE QUARTER ENDED JUNE 30, 1997 This Quarterly Report on Form 10-Q may contain certain projections, estimates and other forward-looking statements that involve a number of risks and uncertainties. While this outlook represents management's current judgment on the future direction of the business, such risks and uncertainties could cause actual results to differ materially from any future performance suggested below. The Company undertakes no obligation to release publicly the results of any revisions to these forward-looking statements to reflect events or circumstances arising after the date hereof. The following should be read in conjunction with "--Risks and Uncertainties" below and the Company's Financial Statements and notes thereto in Item 1 above. Allergan Ligand Retinoid Therapeutics, Inc. (ALRT) commenced operations in June 1995 and received net proceeds of approximately $26.8 million upon issuance of 3.25 million Units (the Offering), each of which consisted of one share of Callable Common Stock and two Warrants, each to purchase one share of Ligand Pharmaceuticals Incorporated (Ligand) common stock. At that time, ALRT also received cash contributions of $50.0 million from Allergan, Inc. (Allergan) and $17.5 million from Ligand (the Contributions). ALRT is utilizing substantially all of the net proceeds of the Offering and the Contributions to continue the efforts of the Allergan Ligand Joint Venture (the Joint Venture), established by Allergan and Ligand in June 1992, to discover, develop and commercialize drugs based on retinoids. On June 3, 1997, the Units separated and the Callable Common Stock and Warrants currently trade separately. The shares of Callable Common Stock are subject to a stock purchase option (the Stock Purchase Option), pursuant to which Ligand, and in the event not exercised by Ligand, Allergan, has an irrevocable option to purchase all, but not less than all, of the Callable Common Stock outstanding at the time such option is exercised at stated exercise prices from June 3, 1997 until the expiration of the Stock Purchase Option on the earlier of June 3, 2000 or a limited period of time after the use of substantially all of the funds available for research and development or the termination of a major agreement among ALRT, Ligand and Allergan due to an event of default. Ligand and Allergan also have the option, which must be exercised together, to acquire assets related to the development of Panretin(TM) (ALRT1057). RESULTS OF OPERATIONS - --------------------- The Company incurred net losses of $9.6 million for the second quarter and $18.8 million for the six months ended June 30, 1997 compared to net losses of $6.1 million and $11.4 million for the comparable periods in 1996. Interest income was $0.5 million for the second quarter and $1.1 million for the first six months of 1997 compared to $1.1 million and $2.1 million for the comparable periods in 1996. Interest income was earned as a result of investment of the remaining unexpended cash held by ALRT. The decrease in interest income in 1997 compared to 1996 was the result of the decrease in unexpended funds as ALRT funds its operating activities. Interest income will decrease in future periods as funds are used in performance of 8 9 MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE QUARTER ENDED JUNE 30, 1997 (Continued) RESULTS OF OPERATIONS (Continued) - --------------------------------- research and development activities, subject to general interest rate trends. Research and development expenses were $9.6 million in the second quarter and $19.1 million for the six months ended June 30, 1997 compared to $6.8 million and $12.7 million for the comparable periods in 1996. Research and development activities were performed primarily by Ligand and Allergan under contracts with ALRT since June 1995. The Company expects research and development spending to continue to increase in 1997 compared to 1996. The increases in spending in 1997 are the result of more rapid discovery and development of a significantly larger library of viable retinoid compounds than anticipated at the time of formation of ALRT. The Company anticipates the increase in spending could result in the use of substantially all of the funds available for research and development remaining in ALRT in late 1997 or early 1998. General and administrative expenses were $466,000 in the second quarter and $770,000 for the six months ended June 30, 1997 compared to $435,000 and $788,000 for the comparable periods in 1996. The Company's activities will be limited to conducting research and development under the agreements with Ligand and Allergan during the terms of such agreements. The Company does not expect to generate any revenues other than interest income during subsequent periods. Consequently, it expects to continue to incur net losses in subsequent periods. LIQUIDITY AND CAPITAL RESOURCES - ------------------------------- As of June 30, 1997, ALRT had cash and cash equivalents and marketable securities of $31.7 million. The proceeds of the Offering together with the Contributions will not be sufficient to enable ALRT to successfully develop and commercialize any products (Products), and ALRT will need to obtain significant additional funds to continue to develop its compounds. Until the expiration of the Stock Purchase Option, which will occur on the earlier of June 3, 2000 or a limited period of time after the use of substantially all the funds available for research and development (which date is currently anticipated to occur in late 1997 or early 1998) or the termination of a major agreement among ALRT, Ligand and Allergan due to an event of default, ALRT is significantly restricted from raising additional funds without Allergan's and Ligand's consent and there can be no assurance that ALRT will have sufficient funds to successfully develop any Products. Such funds will be advanced to ALRT, if at all, at the option of Ligand and Allergan and the decision to make such advances must be a joint decision. As a result, ALRT does not anticipate any future cash inflows other than earnings on unexpended cash balances. Substantial funding will be necessary to complete the development of and to commercialize the Products, if any. ALRT's Board of Directors recently approved a research and development plan for the year ending December 31, 1997 which represents an acceleration in spending on ALRT's retinoid programs. The accelerated spending is the result of more rapid discovery and development of a significantly larger 9 10 MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE QUARTER ENDED JUNE 30, 1997 (Continued) LIQUIDITY AND CAPITAL RESOURCES (Continued) - ------------------------------------------- library of viable retinoid compounds than anticipated at the time of formation of ALRT. ALRT anticipates the acceleration in spending could result in the use of substantially all of the funds available for research and development remaining in ALRT in late 1997 or early 1998. Ligand and Allergan have certain purchase options over the Callable Common Stock and the assets of ALRT, the exercise which could be triggered by the use of substantially all of ALRT's funds. There can be no assurance that Ligand or Allergan will exercise these options. If the Stock Purchase Option is not exercised, ALRT would have to raise substantial funding from third parties through the sale of securities or the licensing of Product or technology rights or both. There can be no assurance that such funds will be available or, if available, will be on commercially reasonable terms. In addition, until the termination of the Stock Purchase Option, ALRT is not able to issue additional capital stock, borrow more than $1 million in the aggregate, declare or pay dividends or make other distributions to stockholders, merge, consolidate or reorganize or liquidate or sell all or substantially all of its assets without the prior written approval of Allergan and Ligand. If ALRT does not use the available funds as provided in the development agreement or otherwise breaches any of its material obligations under any of the major agreements, Allergan and Ligand may have the right to terminate the technology license agreement, and thereby reacquire rights to all technology licensed to ALRT thereunder, including improvements made to such technology using funds provided by ALRT. In the event of such a termination by Allergan and Ligand, ALRT will not receive any royalty or other compensation therefor and it is unlikely that Ligand or Allergan would exercise either their option to acquire all assets related to the Panretin (ALRT1057) development program (the Panretin (ALRT1057) Purchase Option) or the Stock Purchase Option. During the first six months of 1997, ALRT invested its excess cash in money market funds and debt instruments of financial institutions and corporations with strong credit ratings. ALRT has established guidelines relative to diversification and maturities designed to maintain safety and liquidity. The guidelines are periodically reviewed and modified to take advantage of trends in yields and interest rates. The net proceeds from the Offering, combined with income on unexpended cash balances, are anticipated to provide funding for research and development and related administrative activities through the end of 1997, or early 1998. The Company does not currently maintain any line of credit agreements. The Company believes the impact of inflation on its business activities has not been significant to date. RISKS AND UNCERTAINTIES - ----------------------- Early Stage of Development; No Assurance of Successful Development of Technologies or Related Products. ALRT has acquired from each of Ligand and Allergan a license to the retinoid technologies developed and utilized by the 10 11 MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE QUARTER ENDED JUNE 30, 1997 (Continued) RISKS AND UNCERTAINTIES (Continued) - ----------------------------------- Joint Venture (the Core Technologies) for the purpose of accelerating the development and commercialization of retinoid drugs for therapeutic uses. ALRT has agreed with Allergan and Ligand that Allergan and Ligand will conduct research and development on Products in accordance with the development agreement executed by ALRT, Allergan and Ligand (the Development Agreement) for the purpose of identifying and developing Products for commercialization. While some research and development on the Core Technologies and certain Products has been conducted to date, significant product development, including extensive human clinical testing, is still to be undertaken. There can be no assurance that ALRT will be able to complete the development of any marketable products or that such products can be introduced in a timely manner. The successful development of any such products will require, in addition to technical advances, demonstration through human clinical studies that such products are safe and efficacious. Requirement for Additional Funds. The net proceeds of the Offering together with the Contributions will not be sufficient to enable ALRT to successfully develop and commercialize any Products and ALRT will need to obtain significant additional funds to continue the development of its compounds. Until the expiration of the Stock Purchase Option, which will occur on the earlier of June 3, 2000 or a limited period of time after the use of substantially all the funds available for research and development (which date is currently anticipated to occur in late 1997 or early 1998) or the termination of a major agreement among ALRT, Ligand and Allergan due to an event of default, ALRT is significantly restricted from raising additional funds without Allergan's and Ligand's consent and there can be no assurance that ALRT will have sufficient funds to successfully develop any Products. If the Stock Purchase Option is not exercised, ALRT would have to raise substantial additional funding while hiring, or otherwise obtaining access to, research, development and management personnel. See "--Dependence on Ligand and Allergan." ALRT's Board of Directors recently approved a research and development plan for the year ending December 31, 1997 which represents an acceleration in spending on ALRT's retinoid programs. The accelerated spending is the result of more rapid discovery and development of a significantly larger library of viable retinoid compounds than anticipated at the time of formation of ALRT. ALRT anticipates the acceleration in spending could result in the use of substantially all of the funds available for research and development remaining in ALRT in late 1997 or early 1998. Ligand and Allergan have certain purchase options over the Callable Common Stock and the assets of ALRT, the exercise of which could be triggered by the use of substantially all of ALRT's funds. There can be no assurance that Ligand or Allergan will exercise these options. See "--No Assurance of Exercise of Ligand's and Allergan's Options." No Assurance of Exercise of Ligand's and Allergan's Options. Neither Ligand nor Allergan is obligated to exercise either the Stock Purchase Option to acquire the shares of Callable Common Stock or the Panretin (ALRT1057) Purchase Option to acquire the Panretin (ALRT1057) Program Assets, and such options will be exercised only if, in the opinion of their respective Boards of Directors, it is in their respective best interests to do so. There can be no assurance that either Ligand or Allergan will conclude that exercise of either or both options is in their respective best interests. In addition, 11 12 MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE QUARTER ENDED JUNE 30, 1997 (Continued) RISKS AND UNCERTAINTIES (Continued) - ----------------------------------- the exercise of the Panretin (ALRT1057) Purchase Option requires both Allergan and Ligand to conclude that a mutual decision to exercise the Panretin (ALRT1057) Purchase Option is in both of their best interests. If Ligand or Allergan exercises the Stock Purchase Option and pays all or a portion of the exercise price thereof with Ligand common stock or Allergan common stock, rather than with cash, the holders of Callable Common Stock who receive Ligand common stock or Allergan common stock will bear the investment risks associated with the ownership of such stock. Additionally, if Ligand and Allergan exercise the Panretin (ALRT1057) Purchase Option, ALRT will be unable to use the proceeds therefrom until the Stock Purchase Option is exercised or expires unexercised, and, to the extent such exercise price is paid in Ligand common stock or Allergan common stock, ALRT will bear the investment risks associated with the ownership of such stock. If the Stock Purchase Option lapses without exercise, the Core Technologies together with improvements made during the term of the Development Agreement will continue to be exclusively licensed to ALRT, the commercialization agreement executed by ALRT, Allergan and Ligand (the Commercialization Agreement) will remain in effect (subject to termination on 12-months' notice by ALRT, Ligand or Allergan) and each of ALRT, Ligand and Allergan will be free to pursue their own respective business strategies. In such an event, however, ALRT will require substantial additional funds. In such circumstances it is unlikely that such funds will be available on attractive terms, if at all. Furthermore, Allergan or Ligand or a third party could make an offer to acquire ALRT or the Callable Common Stock at a price lower than that set forth in the Stock Purchase Option. Dependence on Ligand and Allergan. Substantially all of the net proceeds of the Offering and the Contributions will be paid by ALRT to Allergan and Ligand under the Development Agreement and, under the Commercialization Agreement, Allergan and Ligand will be primarily responsible for the marketing and manufacturing of the Products, if any are commercialized during its term. ALRT is not expected to have its own research, development, clinical licensing, administration, manufacturing or marketing employees or facilities and thus will be entirely dependent on Allergan and Ligand in all these areas. Subject to their respective obligations under the Development Agreement, consistent with commercially reasonable practices, Allergan and Ligand will have sole discretion to determine the allocation of their respective research, development, clinical, licensing, administration, manufacturing and marketing employees and facilities. Allergan's and Ligand's proprietary and collaborative development, licensing, manufacturing and marketing projects may compete for time and resources with projects undertaken for ALRT pursuant to the Development Agreement and the Commercialization Agreement, thereby delaying development, manufacture and marketing of the Products. Any material adverse change in the business or financial condition of Ligand or Allergan would have a material adverse effect upon ALRT. The Development Agreement and Commercialization Agreement. Allergan and Ligand are the contractors under the Development Agreement and will perform, or cause to be performed, all development activities thereunder. Additionally, Allergan and Ligand will be primarily responsible for the manufacture and marketing of Products under the Commercialization Agreement. ALRT will be responsible for and will pay the development costs that are incurred by Allergan and Ligand under the Development Agreement and the 12 13 MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE QUARTER ENDED JUNE 30, 1997 (Continued) RISKS AND UNCERTAINTIES (Continued) - ----------------------------------- manufacturing and marketing costs incurred by Allergan and Ligand under the Commercialization Agreement. Ligand and Allergan will determine certain activities to be undertaken under the Development Agreement and in all events Ligand and Allergan will have substantial influence over all activities and procedures (including the timing and priorities thereof) to be undertaken under such agreements, subject to the approval of the Board of Directors of ALRT. Neither Ligand nor Allergan has any obligation to complete any development activity after all funds have been expended under the Development Agreement. Ligand's and Allergan's own projects and other third-party projects may compete for time and resources with projects undertaken pursuant to the Development Agreement and with the manufacture and marketing of Products under the Commercialization Agreement and the resources that Allergan and Ligand expend under such agreements may therefore be limited. No Assurance of Successful Manufacturing or Marketing. ALRT has no manufacturing or marketing capability. ALRT will be required to rely on Allergan, Ligand and other third parties approved by Allergan and Ligand to manufacture, sell and otherwise market Products. If ALRT is required to rely on third-party manufacturing and marketing, there can be no assurance that, prior to the expiration of the Commercialization Agreement, Allergan and Ligand will approve such third-party arrangements, that such third-party arrangements can be successfully negotiated or that any such arrangements will be available on commercially reasonable terms. Even if acceptable and timely manufacturing and marketing are available, including manufacturing and marketing of Products by Allergan and Ligand pursuant to the Commercialization Agreement, there can be no assurance that Products developed in accordance with the Development Agreement will be accepted in the marketplace. Losses; No Assurance of Profitability; Lack of Dividends. ALRT was recently formed and has incurred significant operating losses to date. ALRT anticipates that substantially all of the net proceeds of the Offering and the Contributions will be expended prior to the receipt of any revenues by ALRT, resulting in additional significant losses. Further, even if ALRT is able to obtain the funds necessary to successfully develop any Products, there can be no assurance that they can be marketed profitably. Even if such Products are commercialized profitably, the initial losses incurred by ALRT may never be recovered. ALRT is prevented from paying dividends on the Callable Common Stock without the approval of Allergan and Ligand, and accordingly, does not expect to pay any dividends. See "-- Requirement for Additional Funds." Limitation on Certain ALRT Activities. Under its Amended and Restated Certificate of Incorporation, ALRT and its stockholders are prohibited from taking any action or permitting any action to be taken which is inconsistent with Allergan's and Ligand's rights under the Stock Purchase Option. Until the termination of the Stock Purchase Option, ALRT is not be able to issue additional capital stock, borrow more than $1 million in the aggregate, declare or pay dividends or make other distributions to stockholders, merge, consolidate or reorganize, or liquidate or sell all or substantially all of its assets without the prior written approval of Allergan and Ligand. Potential Competition from Allergan or Ligand. Both Allergan and Ligand are engaged in ongoing in-licensing and development of new products. While 13 14 MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE QUARTER ENDED JUNE 30, 1997 (Continued) RISKS AND UNCERTAINTIES (Continued) - ----------------------------------- Allergan and Ligand have licensed all their rights with respect to the Core Technologies, each is allowed under the technology license agreement executed by ALRT, Allergan and Ligand (the Technology License Agreement) to pursue the development of retinoid compounds under certain circumstances which may, in some circumstances, lead to the development of products competitive with the Products, including, in the case of the exercise of the Panretin (ALRT1057) Purchase Option, products based on Panretin (ALRT1057). In addition, following termination of the Stock Purchase Option, Allergan and Ligand will be free to develop products that may compete with the Products. It is possible that the existence of any such competitive products could reduce Allergan's or Ligand's incentive to exercise either the Panretin (ALRT1057) Purchase Option or the Stock Purchase Option. See "--Competition; Technological Change." Potential Loss of Technology by ALRT. Under the Development Agreement and the Commercialization Agreement, ALRT is obligated to make payments to Ligand and Allergan equal in the aggregate to substantially all of the available funds. If ALRT does not use such available funds as provided in the Development Agreement or otherwise breaches any of its material obligations under any of the major agreements with Allergan and Ligand (the Major Agreements), Allergan and Ligand may have the right to terminate the Technology License Agreement, and thereby reacquire rights to all technology licensed to ALRT thereunder, including improvements made to such technology using funds provided by ALRT. In the event of such a termination by Allergan and Ligand, ALRT will not receive any royalty or other compensation therefor and it is unlikely that Ligand or Allergan would exercise either the Panretin (ALRT1057) Purchase Option or the Stock Purchase Option. Acceleration of Stock Purchase Option. If ALRT terminates a Major Agreement due to an event of default by either Allergan or Ligand, the Stock Purchase Option will be exercisable for a period of 30 days by the non-breaching party if the non-breaching party, despite its best efforts, is unable to continue all or a substantial majority of the obligations of the breaching party under such Major Agreement. There can be no assurance that, at that time, the development of the Products will have progressed to a point where Allergan or Ligand will have sufficient information to determine whether to exercise the Stock Purchase Option. As a result, Allergan and Ligand may determine not to exercise the Stock Purchase Option. There can be no assurance that, upon termination of the Development Agreement by ALRT as described above, alternative arrangements for the development of some or all of the Products could be made or that such development of the Products by ALRT would be successful. No Assurance of Market for Warrants or Callable Common Stock. Since June 3, 1997 (the "Separation Date"), the Warrants and the Callable Common Stock have been separately transferable. There can be no assurance that factors related to Ligand, Allergan, their relationship or otherwise will not depress the value of the Warrants, or that factors related to Ligand, Allergan, ALRT or otherwise will not depress the value of Callable Common Stock, in either case reducing the liquidity of an investment in the Callable Common Stock. The existence of the Stock Purchase Option and the Panretin (ALRT1057) Purchase Option may also place a cap on the upside potential of the trading price of the Warrants and/or Callable Common Stock. In addition, while the Panretin (ALRT1057) Purchase Option remains outstanding, the possibility of exercise 14 15 MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE QUARTER ENDED JUNE 30, 1997 (Continued) RISKS AND UNCERTAINTIES (Continued) - ----------------------------------- of such option by Allergan and Ligand may cause the Callable Common Stock to trade at a price which reflects the maximum consideration to be received by ALRT upon exercise of the Panretin (ALRT1057) Purchase Option and the progress made by ALRT in the development of other retinoid compounds. Furthermore, the value of the Callable Common Stock or the Warrants on the public market may be further affected by the uncertainties associated with the exercise of both the Panretin (ALRT1057) Purchase Option and the Stock Purchase Option, factors related to Ligand's business or factors unrelated to either ALRT or Ligand. In the event of the exercise of the Panretin (ALRT1057) Purchase Option, the value of the Callable Common Stock on the public market will be affected by the progress made by ALRT in the development of other retinoid compounds. There can be no assurance that there will be an active trading market for the Warrants or the Callable Common Stock. Attraction and Retention of Key Employees. ALRT is highly dependent on the principal members of Ligand's and Allergan's scientific and management staff, the loss of whose services might impede the achievement of development objectives. Furthermore, Ligand is currently experiencing a period of rapid growth which will require the hiring of significant numbers of scientific, management and operational personnel. Accordingly, the success of Allergan and Ligand in recruiting and retaining management and operational personnel and qualified scientific personnel to perform research and development work in the future will also be critical to ALRT's success. There can be no assurance that Ligand or Allergan will be able to attract and retain personnel required to support ALRT projects on acceptable terms given the competition among numerous pharmaceutical and biotechnology companies, universities and other research institutions for such personnel. No Assurance that Exclusive Relationships will Continue. Ligand has entered into exclusive relationships relating to the in-licensing of technology with certain companies, academic institutions and scientists, including Dr. Ronald Evans of The Salk Institute. The agreements with these companies, institutions and scientists expire at various times, including the consulting agreement with Dr. Evans which expires in July 1998. There can be no assurance that Ligand will desire or be able to continue these relationships upon the expiration of the current agreements. ALRT is unable to ascertain what impact the loss of the services, or relationship, with any of these companies, institutions or scientists would have on its operations or financial position. Patents and Proprietary Technology. The patent positions of pharmaceutical and biopharmaceutical firms, including ALRT, are uncertain and involve complex legal and technical questions for which important legal principles are largely unresolved. In addition, the coverage sought in a patent application can be significantly reduced before or after a patent is issued. This uncertain situation is also affected by revisions to the United States patent law adopted in recent years to give effect to international accords to which the United States has become a party. The extent to which such changes in law will affect the operations of ALRT cannot be ascertained. In addition, there is currently pending before Congress legislation providing for other changes to the patent law which may adversely affect pharmaceutical and biopharmaceutical firms. If such pending legislation is adopted, the 15 16 MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE QUARTER ENDED JUNE 30, 1997 (Continued) RISKS AND UNCERTAINTIES (Continued) - ----------------------------------- extent to which such changes would affect the operations of ALRT cannot be ascertained. ALRT's success will depend in part upon the ability of Ligand, Allergan or ALRT, as the case may be, to obtain strong patent protection both in the United States and other countries. A number of pharmaceutical and biotechnology companies and research and academic institutions have developed technologies, filed patent applications or received patents on various technologies that may be related to the Core Technologies. Some of these patent applications, patents or technologies may conflict with the Core Technologies or patent applications of Ligand, Allergan or ALRT. Any such conflict could limit the scope of the patents, if any, that Ligand, Allergan or ALRT, as the case may be, may be able to obtain or result in the denial of the patent applications of Ligand, Allergan or ALRT, as the case may be. In addition, if patents that cover ALRT's activities are issued to other companies, there can be no assurance that ALRT would be able to obtain licenses to these patents at a reasonable cost or be able to develop or obtain alternative technology. The commercial success of ALRT will also depend in part on ALRT not infringing patents issued to competitors and not breaching the technology licenses that might cover technology used in ALRT's products. It is uncertain whether any third-party patents will require ALRT to alter its products or processes, obtain licenses or cease certain activities. If any licenses are required, there can be no assurance that ALRT will be able to obtain any such license on commercially favorable terms, if at all. Failure by ALRT to obtain a license to any technology that it may require to commercialize its products may have a material adverse impact on ALRT. Litigation, which could result in substantial cost to ALRT, may also be necessary to enforce any patents issued to ALRT or to determine the scope and validity of third-party proprietary rights. Should any of its competitors have prepared and filed patent applications in the United States which claim technology also invented by ALRT, ALRT may have to participate in interference proceedings declared by the United States Patent and Trademark Office (the PTO) in order to determine priority of invention and, thus, the right to a patent for the technology, all of which could result in substantial cost to ALRT to determine its rights. ALRT acquired rights to Panretin (ALRT1057) under an exclusive license from Ligand of a pending patent application. Ligand has informed ALRT that a United States patent has issued to, and foreign counterparts have been filed by, Hoffman-La Roche (Roche) that include claims to a formulation of 9-cis-Retinoic acid (Panretin (ALRT1057)) and use of that compound to treat epithelial cancers. Ligand, on behalf of ALRT, had previously filed an application which has an earlier filing date than the Roche patent and which has claims that Ligand believes are broader than but overlap in part with claims under the Roche patent. Ligand and ALRT are currently investigating the scope and validity of this patent to determine its impact upon the Oral and Topical Panretin (ALRT1057) products. The PTO has informed Ligand that the overlapping claims are patentable to Ligand and has initiated an interference proceeding to determine whether Ligand or Roche is entitled to a patent by having been first to invent the common subject matter. ALRT cannot be assured that Ligand will obtain a favorable outcome in the interference proceeding because of factors not known at this time upon which the outcome 16 17 MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE QUARTER ENDED JUNE 30, 1997 (Continued) RISKS AND UNCERTAINTIES (Continued) - ----------------------------------- may depend. In addition, the interference proceeding may delay the decision of the PTO regarding the Ligand's application, on behalf of ALRT, with claims covering the Oral and Topical Panretin (ALRT1057) products. While the Company believes that the Roche patent does not cover the use of Oral and Topical Panretin (ALRT1057) to treat leukemias such as APL and sarcomas such as KS, or the treatment of skin diseases such as psoriasis, if Ligand, on behalf of ALRT, does not prevail in the interference proceeding, the Roche patent might block the use of Oral and Topical Panretin (ALRT1057) in certain cancers, and Ligand, on behalf of ALRT, may not be able to obtain patent protection for the Oral and Topical Panretin (ALRT1057) products. Competition; Technological Change. Other products and therapies currently exist on the market that would compete directly with the products that ALRT is seeking to develop and market. There can be no assurance that ALRT's products, even if successfully tested and developed, will have sufficient advantages over existing products to cause physicians to adopt them over such other products, or that ALRT's products will offer an economically feasible alternative to such existing products. ALRT is engaged in a rapidly developing field. A number of companies are currently seeking to develop new products and therapies to address many of the diseases addressed by ALRT's IR technology. A number of companies are also pursuing IR-related or STAT-related approaches to drug discovery and development, including Ligand and Allergan. It is expected that the number of companies seeking to develop products and therapies for these markets and the future markets which ALRT may address will increase. There can be no assurance that alternative products and therapies will not be developed that will either render ALRT's proposed products obsolete or that will have advantages that will significantly outweigh those of the products and therapies that ALRT is seeking to develop. Many of ALRT's existing or potential competitors, particularly large pharmaceutical companies, have substantially greater financial, technical and human resources than ALRT. In addition, many of these competitors have significantly greater experience than ALRT in undertaking preclinical testing and human clinical trials of new pharmaceutical products and obtaining regulatory approvals for therapeutic products. Accordingly, ALRT's competitors may succeed in obtaining FDA approval for products more rapidly than ALRT. Furthermore, if ALRT is permitted to commence commercial sales of products, they may also be competing with respect to marketing capabilities, an area in which ALRT does not have substantial experience. In addition to the activities to be performed by each of Ligand and Allergan under the Development Agreement, it is anticipated that Ligand and Allergan will perform research and development work on products other than the retinoid Products being developed by ALRT. Such other products may utilize certain aspects of the Core Technologies or related or similar technologies in other or related areas. Allergan and Ligand, either jointly or alone, are entitled to develop and commercialize using their own funds compounds that ALRT elects not to continue to develop after the compound enters clinical trials or after sufficient data to file an Investigational New Drug Application for the compound has been gathered, so long as (i) the Board of Directors of ALRT shall have first made a reasonable determination that continued work on such compound would not materially conflict or interfere 17 18 MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE QUARTER ENDED JUNE 30, 1997 (Continued) RISKS AND UNCERTAINTIES (Continued) - ----------------------------------- with the interests of the ALRT retinoid program or impair a party's ability to perform its obligations under the Major Agreements and (ii) at least $1 million per year is committed to development of such compound during each of the first two years of development of such compound. In addition, retinoid products acquired by Ligand or Allergan may be commercialized by Ligand or Allergan, as the case may be, so long as such product was being commercially sold or is a product for which an application to market has been filed in the United States or other major market country at the time of its licensing or acquisition. See "-- Potential Competition from Allergan and Ligand." Government Regulation. The manufacturing and marketing of ALRT's products and its ongoing research and development activities are subject to regulation by numerous governmental authorities in the United States and other countries. Prior to marketing, any drug developed by ALRT must undergo rigorous preclinical and clinical testing and an extensive regulatory approval process mandated by the United States Food and Drug Administration (the FDA) and equivalent foreign authorities. These processes can take a number of years and require the expenditure of substantial resources. The time required for completing such testing and obtaining such approvals is uncertain, and approval itself may not be obtained. ALRT may decide to replace its compounds in testing with modified or optimized compounds, thus extending the testing process. In addition, delays or rejections may be encountered based upon changes in FDA policy during the period of product development and FDA regulatory review of each submitted new drug application or product license application. Similar delays may also be encountered in other countries. There can be no assurance that even after such time and expenditures, regulatory approval will be obtained for any products developed by ALRT. Moreover, prior to receiving FDA approval to market its products, ALRT may have to demonstrate that its products represent improved forms of treatment over existing therapies. If regulatory approval of a product is granted, such approval may entail limitations on the indicated uses for which the product may be marketed. Further, even if such regulatory approval is obtained, a marketed product, its manufacturer and its manufacturing facilities are subject to continual review and periodic inspections, and later discovery of previously unknown problems with a product, manufacturer or facility may result in restrictions on such product or manufacturer, including withdrawal of the product from the market. Third Party Reimbursement and Health Care Reform. ALRT's commercial success will be heavily dependent upon the reimburseability of the use of its products. There can be no assurance that Medicare and third-party payors will authorize or otherwise budget reimbursement for such usage at the current authorized levels. Furthermore, federal and state regulations govern or influence the reimbursement to health care providers of fees and capital equipment costs in connection with medical treatment of certain patients. There can be no assurance that action taken by the federal government, if any, with regard to health care reform will not have a material adverse effect on ALRT. If any actions are taken by the federal government, such actions could adversely affect the prospects for future sales of ALRT's products. 18 19 MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE QUARTER ENDED JUNE 30, 1997 (Continued) RISKS AND UNCERTAINTIES (Continued) - ----------------------------------- Product Liability and Insurance. ALRT is subject to the potential product liability risks which are inherent in the testing, manufacturing and marketing of human therapeutic products. ALRT currently does not have product liability insurance, but Allergan and Ligand have added ALRT as an additional named insured on their respective product liability insurance policies. There can be no assurance that Ligand and/or Allergan, as the case may be, will be able to maintain such insurance, that ALRT will be able to obtain product liability insurance at commercially reasonable rates or at all if Ligand and/or Allergan are not able to maintain such insurance on acceptable terms, that any insurance ALRT may obtain can be maintained on acceptable terms, or that insurance will provide adequate coverage against potential liabilities. Hazardous Materials. ALRT's research and development is conducted by Ligand and Allergan on ALRT's behalf and involves the controlled use of hazardous materials, chemicals and various radioactive compounds. Although ALRT believes that Ligand's and Allergan's safety procedures for handling and disposing of such materials comply with the standards prescribed by state and federal regulations, the risk of accidental contamination or injury from these materials cannot be completely eliminated. In the event of an accident, ALRT could be held liable for any damages that result and any such liability could exceed the resources of ALRT. ALRT may be required to reimburse Ligand and/or Allergan for substantial costs they incur to comply with environmental regulations. Conflicts of Interest. ALRT, Allergan and Ligand are separate companies. The best interests of the stockholders of the three companies may not be the same, and decisions made by Ligand or Allergan may adversely affect the interests of the holders of Callable Common Stock and/or the Warrants. Common Management. The Technology License Agreement, Development Agreement, Commercialization Agreement and other agreements executed by ALRT, Allergan and Ligand in connection with the Offering were approved by Allergan and Ligand, as the controlling stockholders of ALRT at the time of such approvals, which may have influenced the Board of Directors of ALRT to enter into such agreements. The current Board of Directors of ALRT is comprised of two persons who are directors and officers of Allergan or Ligand and three persons who are unaffiliated with Allergan or Ligand. Terms of Agreements and Special Stock. The terms of the Technology License Agreement, the Development Agreement, the Commercialization Agreement and other agreements executed by ALRT, Allergan and Ligand in connection with the Offering were determined by Allergan, Ligand and ALRT with the financial advisor to ALRT, Ligand and Allergan in connection with the Offering. The terms of these agreements were not negotiated at arm's-length. The Stock Purchase Option Exercise Price; Panretin (ALRT1057) Purchase Option Exercise Price; Warrant Exercise Price. The exercise prices for the Stock Purchase Option and the Panretin (ALRT1057) Purchase Option and the exercise price of the Warrants were each determined by ALRT, Ligand and Allergan giving consideration to the stage of development of the Core Technologies, the agreements among ALRT, Allergan and Ligand, such other factors as ALRT, 19 20 MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FOR THE QUARTER ENDED JUNE 30, 1997 (Continued) RISKS AND UNCERTAINTIES (Continued) - ----------------------------------- Allergan and Ligand deemed appropriate, and other advice given by their financial advisor. Such prices were not determined on an arms'-length basis. 20 21 Allergan Ligand Retinoid Therapeutics, Inc. PART II - OTHER INFORMATION Item 2. Changes in Securities On June 3, 1997, the Units separated and the Callable Common Stock and Warrants currently trade separately. Item 4. Submission of Matters to a Vote of Security Holders The Company's Annual Meeting of Stockholders was held on June 2, 1997. The following elections and proposals were approved at the Company's Annual Meeting:
Votes Votes Votes Votes Votes For Against Withheld Abstaining Non-Vote --------- ------- -------- ---------- -------- 1. Election of Directors CALLABLE COMMON STOCK --------------------- Harry F. Hixson 2,477,125 0 862 0 772,875 Glenn F. Kiplinger 2,477,197 0 790 0 772,803 Gary L. Neil 2,477,125 0 862 0 772,875 SPECIAL STOCK ------------- David E. Robinson 100 0 0 0 0 William C. Shepherd 100 0 0 0 0 2. Ratification of Independent Auditors 2,477,520 318 0 149 772,013
Item 6. Exhibits and Reports on Form 8-K - Exhibits (numbered in accordance with Item 601 of Regulation S-K) Exhibit 27. Financial Data Schedule - Reports on Form 8-K. None. 21 22 SIGNATURE 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 thereunto duly authorized. Date: August 14, 1997 ALLERGAN LIGAND RETINOID THERAPEUTICS, INC. -------------------- /s/ Dwight J. Yoder -------------------------------------- Dwight J. Yoder Chief Financial Officer and Duly Authorized Officer 22 23 EXHIBIT INDEX Exhibits -------- Exhibit 27. Financial Data Schedule EX-27 2 FINANCIAL DATA SCHEDULE
5 1,000 6-MOS DEC-31-1997 JAN-01-1997 JUN-30-1997 14,260 17,442 0 0 0 32,318 0 0 32,318 4,220 0 0 0 3 28,095 32,318 0 1,112 0 0 19,095 0 0 (18,753) 0 (18,753) 0 0 0 (18,753) (5.77) (5.77)
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