TARGETED GENETICS CORP /WA/
10-Q, 1998-08-07
BIOLOGICAL PRODUCTS, (NO DIAGNOSTIC SUBSTANCES)
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<PAGE>
 
                       SECURITIES AND EXCHANGE COMMISSION
                              Washington, DC 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, 1998
                                      or
          [   ] Transition report pursuant to Section 13 or 15(d) of the
                        Securities Exchange Act of 1934

            For the transition period from _________ to __________


                        Commission File Number: 0-23930
                                                -----------------------


                         TARGETED GENETICS CORPORATION
 -------------------------------------------------------------------------------
            (Exact name of registrant as specified in its charter)

           Washington                                     91-1549568
 ---------------------------------       ---------------------------------------
  (State or other jurisdiction of           (I.R.S. Employer Identification No.)
  incorporation or organization)


             1100 Olive Way, Suite 100, Seattle, Washington 98101
 -------------------------------------------------------------------------------
              (Address of principal executive offices) (Zip Code)


                                (206) 623-7612
 -------------------------------------------------------------------------------
             (Registrant's telephone number, including area code)


     Indicate by 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.

             Yes   [ x ]           No    [    ]

                 Indicate the number of shares outstanding of each of the
         issuer's classes of common stock, as of the latest practicable date.

   Common Stock, $.01 par value                         28,974,741
- ----------------------------------       --------------------------------------
              (Class)                        (Outstanding at July 31, 1998)
<PAGE>
 
                          TARGETED GENETICS CORPORATION

                          Quarterly Report on Form 10-Q
                       For the quarter ended June 30, 1998

TABLE OF CONTENTS

<TABLE> 
<CAPTION> 
                                                                                                       Page No.
                                                                                                       --------
<S>                                                                                                    <C> 
PART I     FINANCIAL INFORMATION

Item 1.    Financial Statements

        a) Condensed Balance Sheets - June 30, 1998 and December 31, 1997                                 3

        b) Condensed Statements of Operations - for the three and six months ended
                 June 30, 1998 and 1997                                                                   4

        c) Condensed Statements of Cash Flows - for the six months ended
                 June 30, 1998 and 1997                                                                   5

        d) Notes to Condensed Financial Statements                                                        6

 Item 2.   Management's Discussion and Analysis of Financial Condition
                 and Results of Operations                                                                6

 Item 3.   Quantitative and Qualitative Disclosure About Market Risk                                      *


PART II    OTHER INFORMATION

 Item 1.   Legal Proceedings                                                                              *

 Item 2.   Changes in Securities                                                                          *

 Item 3.   Defaults Upon Senior Securities                                                                *

 Item 4.   Submission of Matters to a Vote of Security Holders                                            9

 Item 5.   Other Information                                                                              9

 Item 6.   Exhibits and Reports on Form 8-K                                                               9


SIGNATURES                                                                                                10
</TABLE> 


* No information is provided due to inapplicability of the item.

                                       2
<PAGE>
 
PART I      FINANCIAL INFORMATION     
                                      
Item 1.  Financial Statements         

<TABLE> 
<CAPTION> 
                                             TARGETED GENETICS CORPORATION                                          
                                             (a development stage company)                                          
                                               CONDENSED BALANCE SHEETS                                             
                                                                                                                    
                                                                                                                    
                                                                 June 30,             December 31,                      
                                                                   1998                   1997                          
                                                             -----------------       --------------
ASSETS                                                          (Unaudited)                                           
- ------                                                       <C>                     <C>   
<S>                                                        
Current assets:                                                                                                     
       Cash and cash equivalents                                $  1,689,877           $  1,011,845                 
       Securities available for sale                               9,546,936              4,025,976                 
       Prepaid expenses and other                                    296,304                248,278                 
                                                                ------------           ------------ 
              Total current assets                                11,533,117              5,286,099                 
                                                                                                                    
Property, plant and equipment, net                                 3,824,965              3,927,533                 
                                                                                                                    
Other assets                                                         467,167                553,452                 
                                                                ------------           ------------ 
                                                                                                                    
                                                                $ 15,825,249           $  9,767,084                    
                                                                ============           ============
                                                                                                                    
LIABILITIES AND SHAREHOLDERS' EQUITY                                                                                
                                                                                                                    
Current liabilities:                                                                                                
       Accounts payable                                         $  1,495,866           $  1,352,297                 
       Accrued payroll and other liabilities                         278,230                275,876                 
       Current portion of long-term obligations                    1,172,590              1,030,562                 
                                                                ------------           ------------ 
              Total current liabilities                            2,946,686              2,658,735                 
                                                                                                                    
Long-term obligations                                              1,432,116              1,516,762                 
                                                                                                                    
Shareholders' equity:                                                                                               
       Preferred stock                                                     0                      0                 
       Common stock (28,974,741 and 20,211,114 shares                                                               
       outstanding at June 30, 1998 and December 31,                                                                
        1997, respectively)                                       86,191,709             73,401,141                 
       Deficit accumulated during development stage              (74,745,444)           (67,814,735)                
       Accumulated other comprehensive loss                              182                  5,181                
                                                                ------------           ------------   
              Total shareholders' equity                          11,446,447              5,591,587                 
                                                                ------------           ------------ 

                                                                $ 15,825,249           $  9,767,084                    
                                                                ============           ============
</TABLE> 


                            See accompanying notes.

                                       3
<PAGE>
 
Item 1.  Financial Statements (continued)

<TABLE> 
<CAPTION> 
                                                                              TARGETED GENETICS CORPORATION
                                                                              (a development stage company)
                                                                            CONDENSED STATEMENTS OF OPERATIONS
                                                                                       (Unaudited)


                                                                                                                            
                                                             Three months ended                         Six months ended          
                                                                  June 30,                                  June 30,              
                                                    ----------------------------------        ----------------------------------
                                                         1998                 1997                1998                  1997 
                                                    -------------         ------------        ------------          ------------  
<S>                                                 <C>                   <C>                 <C>                   <C> 
 Revenues:                                                                                                                        
     Collaborative agreements                       $          0          $      3,048        $      8,339          $     80,430  
     Investment income                                   135,020               180,478             177,324               410,814  
     Other                                                78,187                98,254             303,731               196,509  
                                                    -------------         ------------        ------------          ------------ 
               Total revenues                            213,207               281,780             489,394               687,753  
                                                    -------------         ------------        ------------          ------------  
 Expenses:                                                                                                                        
     Research and development                          2,628,305             3,316,897           5,834,879             6,368,435  
     In-process research and development                       0                     0                   0                     0  
     General and administrative                          663,768               644,762           1,440,560             1,387,332  
     Interest                                             71,822                94,627             144,664               181,520  
                                                    -------------         ------------        ------------          ------------
               Total expenses                          3,363,895             4,056,286           7,420,103             7,937,287  
                                                    -------------         ------------        ------------          ------------ 
                                                                                                                                  
 Net loss                                           $ (3,150,688)         $ (3,774,506)       $ (6,930,709)         $ (7,249,534)
                                                    ============          ============        ============          ============  
                                                                                                                                 
 Basic and diluted net loss per share               $      (0.12)         $      (0.19)       $      (0.29)         $      (0.36)
                                                    ============          ============        ============          ============
                                                                                                                                 
 Shares used in computation of                                                                                                   
   basic and diluted net loss per share               27,305,728            20,205,624          23,778,020            20,183,954 
                                                    ============          ============        ============          ============  
</TABLE> 

<TABLE> 
<CAPTION> 

                                                          Period from 
                                                          March 9, 1989 
                                                       (date of inception)
                                                            through    
                                                         June 30, 1998
                                                       ----------------
<S>                                                    <C> 
Revenues:                                                               
    Collaborative agreements                              $   2,174,639         
    Investment income                                         3,829,218 
    Other                                                       970,099 
                                                          ------------- 
              Total revenues                                  6,973,956 
                                                          ------------- 
Expenses:                                                               
    Research and development                                            
    In-process research and development                      53,151,871 
    General and administrative                               13,517,911 
    Interest                                                 13,674,402 
                                                              1,375,216 
                                                          -------------  
              Total expenses                                 81,719,400    
                                                          -------------    
Net loss                                                  $ (74,745,444)        
                                                          =============         
</TABLE> 

                            See accompanying notes.

                                       4
<PAGE>
 
Item 1.  Financial Statements (continued)

                         TARGETED GENETICS CORPORATION
                         (A DEVELOPMENT STAGE COMPANY)
                      CONDENSED STATEMENTS OF CASH FLOWS
                                  (Unaudited)

<TABLE> 
<CAPTION> 
                                                                                                                               
                                                                                                                Period from     
                                                                          Six months ended                      March 9, 1989    
                                                                               June 30,                      (date of inception) 
                                                                  -----------------------------------             through       
                                                                      1998                   1997              June 30, 1998
                                                                  -----------            ------------        -----------------
<S>                                                               <C>                    <C>                 <C> 
Operating activities:
Net Loss                                                          $ (6,930,709)          $ (7,249,534)        $ (74,745,444)
Adjustments to reconcile net loss to net cash                                                                                      
    used in operating activities:                                                                                                  
    In-process research and development                                      0                      0            12,867,986        
    Depreciation and amortization                                      851,251                828,138             7,574,793        
    Expenses paid with common stock                                          0                      0                78,500        
    Changes in operating assets and liabilities:                                                                                   
        Increase in other assets                                       (46,775)               (30,342)             (504,851)
        (Increase) decrease in accrued interest on                                                                                 
            securities available for sale                              (24,516)                48,707               (17,517)
        Increase (decrease) in accounts payable                                                                                    
            and accrued liabilities                                     73,721               (211,046)            1,793,991        
                                                                  ------------           ------------         -------------         

                                                                                                                                   
    Net cash used in operating activities                           (6,077,028)            (6,614,077)          (52,952,542)
                                                                                                                                   
Investing activities:                                                                                                              
Purchases of property, plant and equipment                             (81,782)              (528,271)           (9,499,869)
Purchases of securities available for sale                         (12,578,407)                     0           (92,057,303)
Sales of securities available for sale                               7,076,964              3,759,715            82,528,065        
Net cash acquired in RGene acquisition                                       0                      0             1,594,386        
Increase in other assets                                               (15,000)                     0              (784,179)
                                                                  ------------           ------------         -------------         

                                                                                                                                   
    Net cash (used in) provided by investing activities             (5,598,225)             3,231,444           (18,218,900)
                                                                                                                                   
Financing activities:                                                                                                              
Net proceeds from sale of capital stock                             12,890,886                283,007            68,551,665        
Advances from Immunex                                                        0                      0             2,807,316        
Proceeds from equipment financing                                            0                326,287             5,412,245        
Payments under capital leases and installment loans                   (537,601)              (593,276)           (3,909,907)
                                                                  ------------           ------------         -------------         

                                                                                                                                   
    Net cash provided by financing activities                       12,353,285                 16,018            72,861,319        
                                                                  ------------           ------------         -------------         

                                                                                                                                   
Net increase (decrease) in cash and cash equivalents                   678,032             (3,366,615)            1,689,877        
                                                                                                                                   
Cash and cash equivalents, beginning of period                       1,011,845              3,532,568                     0        
                                                                  ------------           ------------         -------------         

                                                                                                                                   
Cash and cash equivalents, end of period                          $  1,689,877           $    165,953         $   1,689,877   
                                                                  ============           ============         =============
</TABLE> 

                            See accompanying notes.

                                       5
<PAGE>
 
ITEM 1.  FINANCIAL STATEMENTS (CONTINUED)

                         TARGETED GENETICS CORPORATION
                         (A DEVELOPMENT STAGE COMPANY)
                    NOTES TO CONDENSED FINANCIAL STATEMENTS
                                  (Unaudited)

Note 1.  Basis of Presentation
- ------------------------------
     The condensed financial statements included herein have been prepared by
Targeted Genetics Corporation (the "Company"), without audit, according to the
rules and regulations of the Securities and Exchange Commission.  Certain
information and footnote disclosures normally included in financial statements
prepared in accordance with generally accepted accounting principles have been
omitted pursuant to such rules and regulations.  The financial statements
reflect, in the opinion of management, all adjustments (which consist solely of
normal recurring adjustments) necessary to present fairly the financial position
and results of operations as of and for the periods indicated.

     The results of operations for the three and six months ended June 30, 1998
are not necessarily indicative of the results to be expected for the full year.

Note 2.  Comprehensive Income
- -----------------------------
     In June 1997, the Financial Accounting Standards Board issued Statement
130, Reporting Comprehensive Income.  Statement 130 established new rules for
the reporting and display of comprehensive income and its components; however,
adoption in 1998 will have no impact on the Company's net loss or shareholders'
equity.  Statement 130 requires unrealized gains or losses on the Company's
available-for-sale securities, which currently are reported in shareholders'
equity, to be included in other comprehensive income and the disclosure of total
comprehensive income.  The total of other comprehensive income was immaterial
during the first  and second quarters of 1998 and 1997.


ITEM 2.  MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS

Risks and Uncertainties
- -----------------------
  This discussion contains forward-looking statements that are subject to
certain risks and uncertainties that could cause actual results to differ
materially from those projected.  The Company's future cash requirements and
expense levels will depend on numerous factors, including continued scientific
progress in the Company's research and development programs; the results of
research and development activities; preclinical studies and clinical trials;
acquisition of products or technology, if any; relationships with existing and
future corporate collaborators, if any; competing technological and market
developments; the time and costs involved in obtaining regulatory approvals; the
costs involved in filing, prosecuting and enforcing patent claims; the time and
costs of manufacturing scale-up and commercialization activities; and other
factors.  Reference is made to the Company's Annual Report on Form 10-K for a
more detailed description of such factors.  Readers are cautioned not to place
undue

                                       6
<PAGE>
 
ITEM 2.  MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS (CONTINUED)

Risks and Uncertainties (continued)
- -----------------------------------
reliance on these forward-looking statements, which speak only as of the date of
this report.  The Company undertakes no obligation to publicly release the
results of any revisions to these forward-looking statements that may be made to
reflect events or circumstances after the date of this report or to reflect the
occurrence of unanticipated events.

Financial Condition
- -------------------
  The Company had $11.2 million in cash, cash equivalents and securities
available for sale as of June 30, 1998, compared to $5.0 million at December 31,
1997. The increase was primarily attributable to the completion of a private
placement of common stock and warrants in April 1998, which resulted in net
proceeds to the Company of approximately $12.7 million, offset by the use of
$6.1 million to fund operations and $538,000 of principal payments on capital
equipment leases and installment loans during the first six months of 1998.

  The Company is a development stage company conducting gene and cell therapy
research and development.  Income earned from investments and, to a lesser
degree, revenues under collaborative agreements have been its only sources of
revenue, covering less than ten percent of expenses.  Gene and cell therapy
products are subject to the risks of failure inherent in the development of
products based on innovative technologies.  Although the Company's technology
appears promising, it is unknown whether any commercially viable products will
result from the Company's research and development.  It is not anticipated that
the Company will have any product-related revenues for a number of years.
Accordingly, the Company expects to incur substantial additional losses over the
next several years and to use its capital resources to fund preclinical and
clinical research programs, development of manufacturing capabilities and the
preparation for commercialization of its products under development.

  The Company currently estimates that, assuming no new revenue sources and its
planned rate of spending, its existing cash, cash equivalents and securities
available for sale will be sufficient to meet its operating and capital
requirements through the second quarter of 1999.  There can be no assurance that
the underlying assumed levels of revenue and expense will prove to be accurate.
Whether or not these assumptions prove to be accurate, the Company will need to
raise substantial additional capital.  The Company intends to seek additional
funding through public or private financing, including equity financing and
through collaborative relationships with other companies.  There can be no
assurance, however, that adequate funds will be available when needed or will be
available on terms favorable to the Company, if at all.

Results of Operations
- ---------------------
  Over the past several years, the Company's net loss has grown, consistent with
the growth in the Company's scope and size of operations.  In February 1998 the
Company announced a reorganization and restructuring plan designed to reduce
operating expenses.  The plan focused the Company's resources on the advancement
of its three lead product opportunities: tgAAV-CFTR, a gene

                                       7
<PAGE>
 
ITEM 2.  MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS (CONTINUED)

Results of Operations (continued)
- ---------------------------------
therapy to treat cystic fibrosis; tgDCC-E1A, a gene therapy product for cancer;
and cytotoxic T lymphocytes (CTLs), a cellular therapy for infectious diseases.
The reorganization plan called for reductions in operating costs throughout the
organization, including positions that were largely associated with programs in
very early stage development.  As a result of the reorganization, the Company
recorded a restructuring charge during the first quarter of 1998 of
approximately $300,000.

  Revenue under collaborative agreements for the periods presented primarily
consisted of amounts earned from Laboratoires Fournier S.C.A. related to tgDCC-
E1A manufacturing and development.
 
  Investment income for the three and six months ended June 30, 1998 decreased
to $135,000 and $177,000, respectively, compared to $180,000 and $411,000 during
the three and six months ended June 30, 1997, respectively.  The decreases were
largely attributable to lower average cash balances for investment in 1998
compared to the same periods in 1997.

  Other revenue for the three and six months ended June 30, 1998 and 1997
represented proceeds from research grants awarded by the National Institutes of
Health.

  Research and development expenses decreased to $2,628,000 and $5,835,000 for
the three and six months ended June 30, 1998, respectively, compared to
$3,317,000 and $6,368,000 in the same 1997 quarters.  The decreases were a
result of the Company's reorganization and restructuring plan which was
implemented in February 1998.  The Company expects to see continued modest year-
to-year decreases in research and development expenses during the remainder of
1998.

 

                                       8
<PAGE>
 
PART II   OTHER INFORMATION

ITEM 4.  SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS

  An annual meeting of the Company's shareholders ("Shareholders") was held on
May 5, 1998 (the "Annual Meeting").  Of the 20,216,714 shares outstanding as of
the record date, March 6, 1998,  16,751,893 shares, or 83% of the total shares
eligible to vote at the Annual Meeting, were represented in person or by proxy.

  Two matters were submitted to a vote of the Shareholders at the Annual
Meeting.  First, an amendment to the 1992 Stock Option Plan providing for an
increase in the number of shares available for grant from 2,000,000 to 2,500,000
was approved by 91% of the votes represented at the meeting.  Second, Jack L.
Bowman and Jeremy Curnock Cook were elected as Directors of the Company, each
receiving greater than 99% of the votes cast at the meeting.

  No other matters were submitted to a vote of the Shareholders.


ITEM 5.  OTHER INFORMATION

  In accordance with the Company's Bylaws, a shareholder proposing to transact
business at the Company's annual meeting must provide written notice of such
proposal, in the manner provided by the Company's Bylaws, not fewer than 60 nor
more than 90 days prior to the date of such annual meeting (or, if the Company
provides less than 60 days notice of such meeting, no later than 10 days after
the date of the Company's notice). In addition, if the Company receives notice
of a shareholder proposal after February 12, 1999, the persons named as proxies
in such proxy statement and proxy will have discretionary authority to vote on
such shareholder proposal.


ITEM 6.  EXHIBITS AND REPORTS ON FORM 8-K

(a)  The following exhibits are filed as part of this report.

<TABLE> 
<CAPTION> 
  Exhibit No.            Description
  -----------            -----------
  <S>              <C> 
     27.1          Financial Data Schedule
</TABLE> 

(b)  A Current Report on Form 8-K, dated April 17, 1998, was filed with the 
Securities and Exchange Commission reporting that Targeted Genetics Corporation 
had completed a private placement of common stock and warrants to four 
institutional investors, raising an aggregate of $13,000,000 based on a per 
share price of $1.50.

     A Current Report on Form 8-K, dated May 20, 1998, was filed with the 
Securities and Exchange Commission containing the Company's April 30, 1998 
unaudited balance sheet, showing the effect of the completed private placement 
referred to above.

                                       9
<PAGE>
 
                                   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 thereunto duly authorized.



                                          TARGETED GENETICS CORPORATION
                                 -----------------------------------------------
                                                  (Registrant)



Date      August 7, 1998            /s/ H. STEWART PARKER
      -----------------------    -----------------------------------------------
                                    H. Stewart Parker, Chief Executive Officer
                                    (Principal Executive Officer)



Date      August 7, 1998            /s/ JAMES A. JOHNSON
      -----------------------    -----------------------------------------------
                                    James A. Johnson, Vice President, Finance
                                    (Principal Financial and Accounting Officer)

                                       10

<TABLE> <S> <C>

<PAGE>
 
<ARTICLE> 5
       
<S>                             <C>
<PERIOD-TYPE>                   6-MOS
<FISCAL-YEAR-END>                          DEC-31-1998
<PERIOD-START>                             JAN-01-1998
<PERIOD-END>                               JUN-30-1998
<CASH>                                       1,689,877
<SECURITIES>                                 9,546,936
<RECEIVABLES>                                        0
<ALLOWANCES>                                         0
<INVENTORY>                                          0
<CURRENT-ASSETS>                            11,533,117
<PP&E>                                      10,788,451
<DEPRECIATION>                             (6,963,486)
<TOTAL-ASSETS>                              15,825,249
<CURRENT-LIABILITIES>                        2,946,686
<BONDS>                                              0
                                0
                                          0
<COMMON>                                    86,191,709
<OTHER-SE>                                (74,745,262)
<TOTAL-LIABILITY-AND-EQUITY>                15,825,249
<SALES>                                              0
<TOTAL-REVENUES>                               489,394
<CGS>                                                0
<TOTAL-COSTS>                                        0
<OTHER-EXPENSES>                             7,420,103
<LOSS-PROVISION>                                     0
<INTEREST-EXPENSE>                             144,664
<INCOME-PRETAX>                                      0
<INCOME-TAX>                                         0
<INCOME-CONTINUING>                                  0
<DISCONTINUED>                                       0
<EXTRAORDINARY>                                      0
<CHANGES>                                            0
<NET-INCOME>                               (6,930,709)
<EPS-PRIMARY>                                    (.34)
<EPS-DILUTED>                                    (.34)
        

</TABLE>


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