BIO TECHNOLOGY GENERAL CORP
10-Q, 1996-05-02
MEDICINAL CHEMICALS & BOTANICAL PRODUCTS
Previous: TERRA INDUSTRIES INC, 8-K, 1996-05-02
Next: NORTECH SYSTEMS INC, ARS, 1996-05-02




                                    FORM 10-Q

                       SECURITIES AND EXCHANGE COMMISSION
                             Washington, D.C. 20549

[X]         QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
                         SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 1996

Commission File Number 0-15313

                          BIO-TECHNOLOGY GENERAL CORP.
             (Exact name of registrant as specified in its charter)

Delaware                                                      13-3033811
(State or other jurisdiction of                         (I.R.S. Employer
incorporation or organization)                          Identification No.)

                 70 Wood Avenue South, Iselin, New Jersey 08830
                    (Address of principal executive offices)

                                 (908) 632-8800
              (Registrant's telephone number, including area code)

                         Former address: Not Applicable

- --------------------------------------------------------------------------------

              (Former name, former address and former fiscal year,
                          if changed since last report)

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, par value $.01 per share,
outstanding as of April 22, 1996                    43,699,000
                                                    ----------




<PAGE>


                                      INDEX

                                                                          Page
                                                                          ----
Part I.   Financial Information                       

  Item 1.   Financial Statements:

            Consolidated Balance Sheets at
               March 31, 1996 and December 31, 1995.....................   3

            Consolidated Statements of Operations
               for the three months ended
               March 31, 1996 and 1995..................................   4

            Consolidated Statement of Changes in
               Stockholders' Equity for the three
               months ended March 31, 1996..............................   5

            Consolidated Statements of Cash Flows
               for the three months ended
               March 31, 1996 and 1995..................................   6

            Notes to Consolidated Financial
               Statements...............................................   7

  Item 2.   Management's Discussion and Analysis
               of Financial Condition and Results
               of Operations............................................   8

Part II.  Other Information

  Item 6.   Exhibits and Reports on Form 8-K............................  13

                                       -2-

<PAGE>

                                   BIO-TECHNOLOGY GENERAL CORP. AND SUBSIDIARIES

PART I. FINANCIAL INFORMATION

                           CONSOLIDATED BALANCE SHEETS
                                 (In thousands)

<TABLE>
<CAPTION>

                                                            March 31, 1996    December 31, 1995
                                                              (Unaudited)
- ------------------------------------------------------------------------------------------------
<S>                                                             <C>              <C> 

ASSETS                                             
Current Assets:
 Cash and cash equivalents...................................   $ 14,314         $   6,886
 Short-term investments......................................      3,464             3,989
 Accounts receivable.........................................      3,335             6,347
 Inventories.................................................      2,613             2,118
 Prepaid expenses and other current assets...................        966             1,247
                                                                --------           -------
  Total current assets.......................................     24,692            20,587

Property and equipment, net..................................      4,919             4,922
Intangibles, net.............................................      3,995             5,078
Patents, net.................................................        438               457
Other assets.................................................        550               693
                                                                --------           -------
  Total assets...............................................   $ 34,594           $31,737
                                                                ========           =======

LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities:
 Current portion of long-term debt...........................   $     27         $      27
 Accounts payable............................................      1,422             1,123
 Other current liabilities...................................      5,057             4,237
                                                                 -------           -------
  Total current liabilities..................................      6,506             5,387
                                                                 -------           -------

Long-term liabilities........................................        655               661
                                                                 -------           -------
Stockholders' equity:
 Preferred stock - $.01 par value; 4,000,000
  shares authorized; no shares issued........................       --                --
 Common stock - $.01 par value; 150,000,000 shares
  authorized; issued: 43,685,000 (43,275,000 at
  December 31, 1995).........................................        437               433
 Capital in excess of par value..............................    118,156           117,390
 Deficit.....................................................    (90,602)          (91,528)
 Less - treasury stock at cost, 83,000 shares................       (340)             (340)
      - deferred compensation................................       (218)             (266)
                                                                --------          --------
  Total stockholders' equity.................................     27,433            25,689
                                                                --------          --------

  Total liabilities and stockholders' equity.................   $ 34,594          $ 31,737
                                                                ========          ========
</TABLE>


The accompanying notes are an integral part of these consolidated balance
sheets.

                                       -3-


<PAGE>


                                   BIO-TECHNOLOGY GENERAL CORP. AND SUBSIDIARIES

                      CONSOLIDATED STATEMENTS OF OPERATIONS

                                   (Unaudited)
                      (in thousands except per share data)

<TABLE>
<CAPTION>

                                                                         Three Months Ended
                                                                              March 31,
                                                                       ----------------------
                                                                       1996              1995
- ---------------------------------------------------------------------------------------------
<S>                                                                  <C>             <C>  

Revenues:
 Product sales......................................                 $ 7,695         $ 5,183
 Contract fees......................................                   2,725              95
 Research and development revenues
  under collaborative agreements....................                      --             188
 Other revenues.....................................                     100              57
 Interest income....................................                     191             226
                                                                     -------         -------
                                                                      10,711           5,749
                                                                     -------         -------
Expenses:
 Research and development...........................                   3,104           2,845
 Cost of product sales .............................                   1,166             652
 General and administrative.........................                   1,920           1,660
 Marketing and sales................................                   1,209              --
 Commissions and royalties..........................                     968             150
 Interest and finance...............................                      35              40
 Write-off in connection with
   litigation.......................................                   1,383              --
                                                                     -------         -------
                                                                       9,785           5,347

Net income (loss) ..................................                 $   926         $   402
                                                                     =======         =======
Earnings (loss) per share...........................                 $  0.02         $  0.01
                                                                     =======         =======
Weighted average number of shares outstanding ......                  47,147          43,397
                                                                     =======         =======

</TABLE>






The accompanying notes are an integral part of these consolidated statements.

                                       -4-



<PAGE>


                                   BIO-TECHNOLOGY GENERAL CORP. AND SUBSIDIARIES

            CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS' EQUITY
                                   (Unaudited)
                                 (in thousands)

<TABLE>
<CAPTION>

                                       Common Stock     
                                      --------------    Capital in
                                               Par       Excess of               Treasury   Deferred    Stockholders'
                                      Shares   Value     Par Value     Deficit     Stock  Compensation     Equity
- ----------------------------------------------------------------------------------------------------------------------
<S>                                    <C>        <C>      <C>         <C>          <C>         <C>         <C>

Balance, December 31, 1995.........    43,275     $433     $117,390    $(91,528)    $(340)      $(266)      $25,689


Issuance of common stock. .........         3                    20                                              20
Exercise of stock options..........       405        4          740                                             744
Issuance of common stock on
  Series B note conversions
  (including capitalized
  interest)........................         2                     6                                               6
Amortization of deferred
 compensation......................                                                                48            48
Net income for three months
 ended March 31, 1996. . ..........                                         926                                 926
                                       ------     ----     --------    ---------    ------      ------      -------
Balance, March 31, 1996............    43,685     $437     $118,156    $(90,602)    $(340)      $(218)      $27,433
                                       ======     ====     ========    =========    ======      ======      =======

</TABLE>

The accompanying notes are an integral part of this consolidated statement.

                                       -5-


<PAGE>


                                 BIO-TECHNOLOGY GENERAL CORP. AND SUBSIDIARIES

                      CONSOLIDATED STATEMENTS OF CASH FLOWS
                                   (Unaudited)
                                 (in thousands)

                                                              Three Months
                                                             Ended March 31,
                                                         ----------------------
                                                           1996        1995
- -------------------------------------------------------------------------------
Cash flows from operating activities:
 Net income .........................................    $   926     $   402
 Adjustments to reconcile net income to net
  cash provided by operating activities:
  Write-off in connection with litigation ...........      1,383        --
  Depreciation and amortization .....................        771         782
  Gain on disposal of fixed assets ..................       --            (7)
  Gain on sales of short-term investments ...........        (12)       --
  Common stock as payment for services ..............         20          22
  Change in: receivables ............................      3,012        (458)
             inventories ............................       (495)       (201)
             prepaid expenses and other current 
              assets ................................       (276)       (299)
             accounts payable .......................        299        (371)
             other assets ...........................         (8)         25
             other current liabilities ..............      1,020       1,258
                                                         -------     -------
 Net cash provided by operating activities ..........      6,640       1,153
                                                         -------     -------
Cash flows from investing activities:
 Short-term investments .............................       (964)       --
 Capital expenditures ...............................       (438)       (327)
 Intangibles ........................................        (55)       --
 Proceeds from sales of short-term investments ......      1,501        --
 Change in patents ..................................       --           (22)
 Proceeds from sales of fixed assets and investment .       --            25
                                                         -------     ------- 
 Net cash used in investing activities ..............         44        (324)
                                                         -------     -------
Cash flows from financing activities:
 Proceeds from issuance of common stock .............        744          43
 Repayment of common stock subscriptions ............       --            75
 Interest on Series A and Series B Notes ............       --            (8)
 Purchase of treasury stock .........................       --           (37)
 Repayment of Series A Notes ........................       --           (31)
                                                         -------     -------
Net cash provided by financing activities ...........        744          42
                                                         -------     -------
Net increase in cash and cash equivalents ...........      7,428         871
                                                         -------     ------- 
Cash and cash equivalents at beginning of year ......      6,886      16,891
                                                         -------     -------
Cash and cash equivalents at end of period ..........    $14,314     $17,762
                                                         =======     =======
Supplementary Information
Non-cash investing and financing activities:
 Series A and Series B note conversions .............    $     6     $   185
Other information:
 Interest paid ......................................    $     5     $    13



The accompanying notes are an integral part of these consolidated statements.


                                       -6-


<PAGE>


                                   BIO-TECHNOLOGY GENERAL CORP. AND SUBSIDIARIES

                   NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

Note 1: Statement on Adjustments

In the opinion of management, the condensed consolidated financial statements
include all adjustments, consisting of only normal recurring accruals,
considered necessary for a fair presentation. Due to fluctuations in quarterly
revenues earned, operating results for interim periods are not necessarily
indicative of the results that may be expected for the full year. The accounting
policies continue unchanged from December 31, 1995. For further information,
refer to the Consolidated Financial Statements and footnotes thereto included in
the Company's Annual Report on Form 10-K for the fiscal year ended December 31,
1995.

Note 2: Income Taxes

The Company has not provided any income taxes for the three months ended March
31, 1996 and 1995 as any interim tax provision would be offset by available net
operating loss carryforwards.

Note 3: Write-Off in connection with Litigation

On December 1, 1994, Genentech, Inc. filed a lawsuit against BTG in the United
States District Court for the District of Delaware alleging that BTG's
importation of human growth hormone ("hGH") infringed two Genentech process
patents. In January 1995, BTG commenced an action against Genentech in the
United States District Court for the Southern District of New York seeking,
among other things, declaratory judgment as to the non-infringement, invalidity
and unenforceability of such Genentech patents. The Delaware action was
consolidated with the New York action, and in August 1995 the United States
District Court for the Southern District of New York granted a preliminary
injunction prohibiting the commercial introduction in the U.S. of BTG's hGH. BTG
appealed to the United States Court of Appeals for the Federal Circuit ("CAFC"),
which in April 1996 affirmed the preliminary injunction obtained by Genentech,
finding that Genentech had established before the District Court a reasonable
likelihood of success on the merits of its patent infringement claim. The case
now returns to the Federal District Court in New York for further proceedings
and trial. During 1995, the Company incurred total legal fees relating to this
litigation of $824,000, which amount was capitalized but subsequently
written-off in the first quarter of 1996. In addition, the Company wrote-off
previously capitalized expenses incurred in connection with the preparation for
launch of hGH in the United States. The Company is currently evaluating its
options in light of the CAFC decision. If the Company continues to pursue the
litigation with Genentech, it will incur substantial legal fees in defending and
prosecuting these lawsuits.

                                       -7-


<PAGE>


                                  BIO-TECHNOLOGY GENERAL CORP. AND SUBSIDIARIES

           MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION
                            AND RESULTS OF OPERATIONS

                        Three months ended March 31, 1996
                 compared with three months ended March 31, 1995

  This Report contains forward-looking statements which involve risks and
uncertainties. The Company's actual results may differ significantly from the
results discussed in the forward-looking statements. Factors that might cause
such a difference include, but are not limited to, those discussed below and in
the Company's Annual Report on Form 10-K for the year ended December 31, 1995.

Results of Operations:

The Company has been principally engaged in research and product development
activities since it commenced operation in October 1980 and has incurred
substantial net losses from inception.

The Company reported net income of approximately $0.9 million or $0.02 per share
in the three months ended March 31, 1996 compared to a net income of $0.4
million or $0.01 per share in the three months ended March 31, 1995. The Company
had approximately 0.2 million additional shares outstanding for the three months
ended March 31, 1996 as compared to the same period in 1995.

Revenues from product sales, derived primarily from the Company's human growth
hormone ("hGH"), pharmaceutical grade hyaluronic acid ("BioLon(R)") and
Oxandrolone ("Oxandrin(R)") products, amounted to $7,695,000 and $5,183,000, or
73% and 94% of revenues (exclusive of interest income), for the three month
periods ended March 31, 1996 and 1995, respectively. Sales of hGH were
$5,207,000 and $3,840,000 in the three months ended March 31, 1996 and 1995, or
68% and 75% of product sales, respectively. The increase in sales of hGH was
primarily the result of increased sales to JCR Pharmaceuticals Co., Ltd., the
Company's exclusive distributor in Japan. Sales of BioLon were $873,000 and
$726,000, or 11% and 14% of product sales, in the three month period ended March
31, 1996 and 1995, respectively. The increase in sales of BioLon was mainly due
to new product launches during the first quarter of 1996. In December 1995 the
Company launched Oxandrin in the United States and revenues from Oxandrin
product sales were $502,000, or 7% of total product sales, in the three months
ended March 31, 1996. This amount, together with the approximately $2,992,000
sold to Quantum Health Resources, BTG's exclusive distributor, in December 1995
in connection with the product launch, represented Quantum's product inventory
needs for the first several months following the product's introduction. In
aggregate, $1,113,000 and $617,000 were earned from sales of other products for
the three month periods ended March 31, 1996 and 1995, respectively.

For the three month periods ended March 31, 1996 and 1995 contract fees of
$2,725,000 and $95,000, or 26% and 2%, respectively, of revenues (exclusive of
interest income), were earned. Of the contract fees earned in the three months
ended March 31, 1996, $2,500,000, or 92% of total contract fees, was earned in
respect of vitamin D, of which $2,000,000 was earned in respect of a fee paid to
its European licensee in connection with termination of a sublicense and
$500,000 was earned in connection with the license of distribution rights in the
United States, and $75,000 was earned in respect of BioLon. For the three months
ended March 31, 1995, $85,000, or 89% of total contract fees, was earned in
respect of the license of the marketing rights for the Company's hGH in South
America.

                                       -8-


<PAGE>


                                 BIO-TECHNOLOGY GENERAL CORP. AND SUBSIDIARIES

For the three month periods ended March 31, 1995 research and development
revenues under collaborative agreements of $188,000, or 3% of revenues
(exclusive of interest income), was earned, all of which was earned with respect
to AIDS research for the National Institutes of Health ("NIH").

During the three months ended March 31, 1996 and 1995, other revenues, which
consist primarily of partial funding of several of the Company's research and
development projects by the Chief Scientist of the Israeli government ("Chief
Scientist"), were $100,000 and $50,000, respectively, or 1% of revenues
(exclusive of interest income) for each period. For the three months ended March
31, 1996, Chief Scientist funding represented 100% of other revenues as compared
with 88% in the same period in 1995.

Interest income on the Company's investment portfolio amounted to $191,000 and
$226,000 for the three month periods ended March 31, 1996 and 1995,
respectively. The decrease in interest income derived primarily from lower
average cash balances in the three months ended March 31, 1996 as compared to
the same period in 1995.

The Company conducts research on potential products for which it has retained
future rights for its own account and on behalf of its partners for which it
receives certain current revenues and, if successful, future revenues in the
form of royalties or manufacturing rights. Expenditures for research and
development in the three month periods ended March 31, 1996 and 1995 were
$3,104,000 and $2,845,000, respectively. The increase in these expenditures
resulted primarily from an increase in expenses and headcount associated with
the clinical studies conducted by the Company. Expenditures for research and
development in the three months ended March 31, 1995 include $673,000 on behalf
of Bio-Cardia Corporation, which were not reimbursed to the Company. See
"-Liquidity and Capital Resources."

Cost of product sales, primarily related to commercial sales of hGH, BioLon and
Oxandrin, were $1,166,000 and $652,000 in the three month periods ended March
31, 1996 and 1995, respectively. Cost of product sales as a percentage of
product sales varies from year to year and quarter to quarter depending on the
quantity and mix of products sold. Cost of product sales as a percentage of
product sales is expected to decrease as the quantity sold increases due to
economies of scale. In addition, certain products, such as hGH, have a lower
cost of sales than other products.

General and administrative expenses for the three month periods ended March 31,
1996 and 1995 were $1,920,000 and $1,660,000, respectively. The increase
primarily resulted from an increase in salaries, mainly in respect of business
development, public relations and professional fees.

Marketing and sales expenses for the three months ended March 31, 1996 were
$1,209,000. These expenses relate primarily to the sales and marketing force in
the United States which the Company established during 1995 to promote
distribution of Oxandrin and the Company's other products in the United States.

Commissions and royalties expenses for the three months ended March 31, 1996 and
1995 were approximately $968,000 and $150,000, respectively. These expenses
consist primarily of royalties to entities from which the Company licensed
certain of its products and to the Chief Scientist.

For the three month periods ended March 31, 1996 and 1995 the Company recorded
interest and finance expenses of $35,000 and $40,000, respectively.

In the three months ended March 31, 1996, the Company wrote-off $1,383,000 of
capitalized expenses relating to human growth hormone as a result of the
affirmation by the United States Court Appeal for the Federal Circuit of a
preliminary injunction obtained by Genentech, Inc. prohibiting the Company from
marketing its human growth hormone in the United States. The write-off consists
of legal costs related

                                                     -9-



<PAGE>


                                  BIO-TECHNOLOGY GENERAL CORP. AND SUBSIDIARIES

to the litigation with Genentech and U.S. hGH launch preparation costs. See "-
Liquidity and Capital Resources."

LIQUIDITY AND CAPITAL RESOURCES

The Company's working capital at March 31, 1995 was $18,186,000 as compared to
$15,200,000 at December 31, 1995.

The Company's cash requirements have been and continue to be satisfied primarily
through (i) product sales, (ii) funding of projects through collaborative
research and development arrangements, (iii) contract fees, (iv) government of
Israel funding of a portion of certain research and development projects, and
(v) equity and debt financings. There can be no assurance that these financing
alternatives will be available in the future to satisfy the Company's cash
requirements.

The major portion of the Company's revenues is derived from product sales and
the Company's collaborative arrangements, under which the Company may earn
up-front contract fees, may receive funding for additional research, is
reimbursed for producing certain experimental materials, may be entitled to
certain milestone payments, may sell product at specified prices and may receive
royalties on sales of product. Revenues have in the past displayed and will in
the immediate future continue to display significant variations due to the
obtaining of new research and development contracts and licensing arrangements,
the completion or termination of such contracts and arrangements, the timing and
amounts of milestone payments and the timing of regulatory approvals of
products.

The Company manages its Israeli operations with the object of protecting against
any material net financial loss in U.S. dollars from the impact of Israeli
inflation and currency devaluation on its non-U.S. dollar assets and
liabilities. The Bank of Israel's monetary policy is to manage the exchange rate
while allowing the Consumer Price Index to rise by approximately 14% in 1994, 8%
in 1995 and at a 4% annual rate in the three month period ended March 31, 1996.
For those expenses linked to the Israeli Shekel, such as salaries and rent, this
resulted in corresponding increases in these costs in U.S. dollars. In 1994 and
1995 the Shekel was devalued by approximately 1% and 4%, respectively, against
the U.S. dollar. To the extent that expenses in Shekels exceed the Company's
income in Shekels (which to date have consisted primarily of research and
development funding from the Chief Scientist and sales of Bio-Tropin(TM), the
Company's human growth hormone product in Israel, and BioLon in Israel), the
devaluations of Israeli currency have been and will continue to be a benefit to
the Company's financial condition. However, should the Company's income in
Shekels exceed its expenses in Shekels in any material respect, the devaluation
of the Shekel will adversely affect the Company's financial condition. Further,
to the extent the devaluation of the Shekel with respect to the U.S. dollar does
not substantially offset the increase in the costs of local goods and services
in Israel, the Company's financial results will be adversely affected as local
expenses expressed in U.S. dollar terms will increase. There can be no assurance
that the government of Israel will continue to devalue the Shekel from time to
time to offset the effects of inflation in Israel.

The Company maintains its funds in money market funds, commercial paper and
other liquid short-term debt instruments. The Company's investment policy is to
preserve principal and to avoid risk.

The cash flows of the Company have fluctuated significantly due to the impact of
net income and losses, capital spending, working capital requirements and
issuance of common stock and other financings. The Company expects that cash
flow in the near future will be primarily determined by the levels of net income
(loss) plus depreciation and amortization, and financings, if any, undertaken by
the Company. Net cash provided by operations was $6,640,000 and $1,153,000 in
the three months ended March 3, 1996 and

                                      -10-


<PAGE>


                                   BIO-TECHNOLOGY GENERAL CORP. AND SUBSIDIARIES

1995, respectively. The increase in net cash provided by operating activities in
the first quarter of 1996 was primarily the result of higher net income, a
write-off of legal costs related to the litigation with Genentech and U.S. hGH
launch preparation costs, a decrease in accounts receivable and an increase in
other current liabilities, partially offset by an increase in inventories and in
prepaid expenses and other current assets.

The Company does not currently have any material commitments for capital
expenditures.

At March 31, 1996, intangibles, net consist of (i) $2,389,000 (net of
amortization) relating to the repurchase of all rights to hGH previously
licensed to The DuPont Merck Pharmaceutical Company, together with all rights to
all data generated in pharmacological, toxicological and clinical studies and
encompassed in the Investigational New Drug Application and New Drug Application
files then pending with the U.S. Food and Drug Administration for the treatment
of human growth hormone-deficient children and (ii) $1,606,000 (net of
amortization) relating to the reacquisition of all rights to human growth
hormone licensed to Smithkline Beecham.

The Company is party to several proceedings relating to patents owned by it or
others. The Company cannot predict the costs of such proceedings, and there can
be no assurance that such costs will not be significant. Should the Company be
unsuccessful in any of these proceedings, it may be unable to commercialize the
products which are the subject of such proceedings in certain countries, and may
be unable to produce the products in Israel, which could have a material adverse
effect on the Company's revenues and results of operations.

On March 16, 1993, Genentech filed a complaint with the U.S. International Trade
Commission (the "ITC") alleging, among other things, that BTG's importation of
hGH into the United States violates Section 337 of the Tariff Act of 1930
because of the existence of certain claims in U.S. patents of Genentech.
Genentech sought an immediate investigation and an order that BTG cease and
desist from importing hGH into the United States. The trial on the Genentech
complaint was held in April 1994. In January 1995 the ITC issued a final
decision dismissing the complaint with prejudice as a sanction for Genentech's
conduct which resulted in an incomplete record and violated the due process
rights of BTG and NovoNordisk A/S, another respondent in the proceeding. The ITC
also found no violation by BTG of Section 337 of the Tariff Act of 1930.
Genentech appealed the ITC decision to the United States Court of Appeals for
the Federal Circuit (the "CAFC"). The appeal was heard on December 4, 1995, and
a decision is pending. During 1993 and 1994, BTG incurred total legal fees of
approximately $4.2 million relating to the ITC proceeding.

On December 1, 1994, Genentech filed a lawsuit against BTG in the United States
District Court for the District of Delaware alleging that BTG's importation of
hGH infringed two Genentech process patents. In January 1995, BTG commenced an
action against Genentech in the United States District Court for the Southern
District of New York seeking, among other things, declaratory judgment as to the
noninfringement, invalidity and unenforceability of such Genentech patents. The
Delaware action was consolidated with the New York action, and in August 1995
the United States District Court for the Southern District of New York granted a
preliminary injunction prohibiting the commercial introduction in the U.S. of
BTG's hGH. BTG appealed to the CAFC, and the appeal was heard on December 4,
1995 (during the same session as the ITC appeal discussed above). In April 1996,
the CAFC affirmed the preliminary injunction obtained by Genentech, finding that
Genentech had established before the District Court a reasonable likelihood of
success on the merits of its patent infringement claim. The case now returns to
the Federal District Court in New York for further proceedings and trial. During
1995, the Company incurred total legal fees relating to this litigation of
approximately $824,000, which amount was capitalized but subsequently
written-off in the first quarter of 1996. The Company is currently evaluating

                                      -11-


<PAGE>


                                   BIO-TECHNOLOGY GENERAL CORP. AND SUBSIDIARIES

its options in light of the CAFC decision. If the Company continues to pursue
the litigation with Genentech, it will incur substantial legal fees in defending
and prosecuting these lawsuits.

The Company believes that its remaining cash resources as of March 31, 1996,
together with anticipated product sales, scheduled payments to be made to BTG
under its current agreements with pharmaceutical partners and third parties, the
proceeds from sales of equity and continued funding from the Chief Scientist at
current levels, will be sufficient to fund the Company's ongoing operations for
the foreseeable future. There can, however, be no assurance that product sales
will occur as anticipated, that scheduled payments will be made by third
parties, that current agreements will not be canceled, that the Chief Scientist
will continue to provide funding at current levels, or that unanticipated events
requiring the expenditure of funds will not occur. The satisfaction of the
Company's future cash requirements will depend in large part on the status of
commercialization of the Company's products, the Company's ability to enter into
additional research and development and licensing arrangements, and the
Company's ability to obtain additional equity investments, if necessary. There
can be no assurance that the Company will be able to obtain additional funds if
needed or, if such funds are available, that such funding will be on favorable
terms. In addition, the indentures under which the Company's debt securities
were issued limit the ability of the Company to satisfy its cash requirements
through borrowings or the issuance of debt securities, and prohibit the sale of
equity securities at a price per share of less than $1.00 (as adjusted under
certain circumstances). The Company continues to seek additional collaborative
research and development and licensing arrangements, in order to provide revenue
from sales of certain products and funding for a portion of the research and
development expenses relating to the products covered, although there can be no
assurance that the Company will be able to obtain such agreements.

                                      -12-


<PAGE>


                                  BIO-TECHNOLOGY GENERAL CORP. AND SUBSIDIARIES

Part II. OTHER INFORMATION

Item 6.  Exhibits and Reports on Form 8-K

         (b) Reports on Form 8-K:

             Current Report on Form 8-K dated April 8, 1996, relating to
             the decision of the United States Court of Appeals for the
             Federal Circuit to affirm the district court's grant of a
             preliminary injunction prohibiting the importation of the
             Company's human growth hormone into the United States.

                                      -13-


<PAGE>


                                   BIO-TECHNOLOGY GENERAL CORP. AND SUBSIDIARIES

                                   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.


                                BIO-TECHNOLOGY GENERAL CORP.
                                    (Registrant)


                                By:  /s/ SIM FASS
                                     -----------------------------
                                     Sim Fass
                                     President and
                                     Chief Executive Officer,
                                     Principal Executive Officer


                                     /s/ YEHUDA STERNLICHT
                                     -----------------------------
                                     Yehuda Sternlicht
                                     Vice President-Finance and
                                     Chief Financial Officer,
                                     Principal Financial and Accounting Officer


Dated: April 30, 1996

                                      -14-


<TABLE> <S> <C>

<ARTICLE>                     5
<LEGEND>
THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM THE
CONSOLIDATED BALANCE SHEET AND THE CONSOLIDATED STATEMENT OF OPERATIONS AND IS
QUALIFIED IN ITS ENTIRETY BY REFERENCE TO SUCH FINANCIAL STATEMENTS.
</LEGEND>
<MULTIPLIER>                  1,000
       
<S>                                      <C>
<PERIOD-TYPE>                            3-MOS
<FISCAL-YEAR-END>                        DEC-31-1996
<PERIOD-END>                             MAR-31-1996
<CASH>                                        14,314
<SECURITIES>                                   3,464
<RECEIVABLES>                                  3,335
<ALLOWANCES>                                       0
<INVENTORY>                                    2,613
<CURRENT-ASSETS>                              24,692
<PP&E>                                         4,919
<DEPRECIATION>                                     0
<TOTAL-ASSETS>                                34,594
<CURRENT-LIABILITIES>                          6,506
<BONDS>                                          655
                              0
                                        0
<COMMON>                                         437
<OTHER-SE>                                    34,157
<TOTAL-LIABILITY-AND-EQUITY>                  34,594
<SALES>                                        7,695
<TOTAL-REVENUES>                              10,711
<CGS>                                          1,166
<TOTAL-COSTS>                                  9,750
<OTHER-EXPENSES>                                   0
<LOSS-PROVISION>                                   0
<INTEREST-EXPENSE>                                35
<INCOME-PRETAX>                                  926
<INCOME-TAX>                                       0
<INCOME-CONTINUING>                              926
<DISCONTINUED>                                     0
<EXTRAORDINARY>                                    0
<CHANGES>                                          0 
<NET-INCOME>                                     926
<EPS-PRIMARY>                                   0.02
<EPS-DILUTED>                                      0
        







</TABLE>


© 2022 IncJournal is not affiliated with or endorsed by the U.S. Securities and Exchange Commission