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UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT
OF 1934.
For the quarterly period ended June 30, 1999
Commission File Number 0-20945
MEDI-JECT CORPORATION
161 Cheshire Lane, Suite 100
Minneapolis, Minnesota 55441
(612) 475-7700
A Minnesota Corporation IRS Employer ID No. 41-1350192
----------------
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
------ ------
The number of shares outstanding of the Registrant's Common Stock, $.01 par
value, as of August 11, 1999, was 1,424,729.
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1
MEDI-JECT CORPORATION
INDEX
PAGE
----
PART I. FINANCIAL INFORMATION
ITEM 1. Financial Statements (Unaudited)
Balance Sheets, as of December 31, 1998 and
June 30, 1999................................................ 3
Statements of Operations for the six and three months ended
June 30, 1998 and 1999....................................... 4
Statements of Cash Flows for the six months ended
June 30, 1998 and 1999....................................... 5
Notes to Financial Statements................................ 6
ITEM 2. Management's Discussion and Analysis of Financial Condition
and Results of Operations.................................... 7
ITEM 3. Quantitative and Qualitative Disclosures About Market Risk... 10
PART II. OTHER INFORMATION
ITEM 6. Exhibits and Reports on Form 8-K............................. 11
SIGNATURES............................................................. 15
2
MEDI-JECT CORPORATION
BALANCE SHEETS
(UNAUDITED)
December 31, June 30,
1998 1999
----------- -------------
ASSETS
Current assets:
Cash and cash equivalents..................................... $2,852,285 $ 1,645,947
Accounts receivable, less allowance for doubtful accounts of
$25,000 and $25,000, respectively............................ 275,694 211,449
Inventories................................................... 592,185 374,336
Prepaid expenses and other assets............................. 52,006 56,846
---------- ------------
3,772,170 2,288,578
---------- ------------
Equipment, furniture and fixtures, net............................. 1,278,456 1,199,171
---------- ------------
Patent rights, net................................................. 283,805 278,624
---------- ------------
$5,334,431 $ 3,766,373
========== ============
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities:
Accounts payable............................................. $ 250,512 $ 250,586
Accrued expenses and other liabilities....................... 236,191 183,874
Deferred Revenue............................................. 216,000 --
Capital lease obligations - current maturities............... 1,721 593
---------- ------------
704,424 435,053
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Shareholders' equity:
Series A Convertible Preferred Stock: $0.01 par; authorized
10,000 shares; 1,000 issued and outstanding at
December 31,1998, and June 30, 1999, respectively;
aggregate liquidation preference of $1 million............. 10 10
Common Stock: $0.01 par; authorized 3,400,000 shares;
1,424,752 and 1,424,729 issued and outstanding at
December 31, 1998 and June 30, 1999, respectively.......... 14,247 14,247
Additional paid-in capital................................... 24,911,694 24,926,137
Accumulated deficit.......................................... (20,295,944) (21,609,074)
------------ ------------
4,630,007 3,331,320
------------ ------------
$ 5,334,431 $ 3,766,373
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See accompanying notes to financial statements.
3
MEDI-JECT CORPORATION
STATEMENTS OF OPERATIONS
(UNAUDITED)
For Three Months Ended For Six Months Ended
------------------------------------------ ------------------------------------------
June 30, 1998 June 30, 1999 June 30, 1998 June 30, 1999
------------------------------------------ ------------------------------------------
Revenues:
Product Sales........................ $ 624,670 $ 391,604 $ 1,233,865 $ 959,275
Licensing & product development...... 130,847 185,291 434,625 1,209,608
----------- ----------- ----------- -----------
755,517 576,895 1,668,490 2,168,883
----------- ----------- ----------- -----------
Operating Expenses:
Cost of sales........................ 536,778 348,092 1,004,601 820,839
Research and development............. 601,170 525,063 1,193,656 1,185,585
General and administrative........... 566,815 488,526 1,111,627 974,209
Sales and marketing.................. 198,869 224,030 445,712 488,235
----------- ----------- ----------- -----------
1,903,632 1,585,711 3,755,596 3,468,868
----------- ----------- ----------- -----------
Net operating loss.................... (1,148,115) (1,008,816) (2,087,106) (1,299,985)
----------- ----------- ----------- -----------
Other income (expense):
Interest and other income............ 83,460 23,347 178,053 49,446
Interest and other expense........... (10,233) (12,538) (11,391) (12,589)
----------- ----------- ----------- -----------
73,227 10,809 166,662 36,857
----------- ----------- ----------- -----------
Net loss.............................. $(1,074,888) $ (998,007) $(1,920,444) $(1,263,128)
=========== =========== =========== ===========
Preferred stock dividends............. -- (25,000) -- (50,000)
----------- ----------- ----------- -----------
Net loss applicable to common shares.. $(1,074,888) $(1,023,007) $(1,920,444) $(1,313,128)
=========== =========== =========== ===========
Basic and diluted net loss
per common share.................... $ (.76) $ (.72) $ (1.35) $ (.92)
=========== =========== =========== ===========
Basic and diluted weighted average
common shares outstanding 1,420,287 1,424,729 1,417,319 1,424,733
See accompanying notes to financial statements.
4
MEDI-JECT CORPORATION
STATEMENTS OF CASH FLOWS
(UNAUDITED)
For Six Months Ended
----------------------------------------------
June 30, 1998 June 30, 1999
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Cash flows from operating activities:
Net loss................................................. $(1,920,444) $(1,263,128)
Adjustments to reconcile net loss to net
cash used in operating activities:
Depreciation and amortization....................... 215,682 211,655
Loss from disposal of assets........................ 9,445 35,444
Interest on marketable debt securities.............. (93,147) --
Non-cash compensation -- 14,443
Other............................................... 3,816 --
Changes in operating assets and liabilities:
Accounts receivable................................. 409,516 64,245
Inventories......................................... (194,588) 217,849
Prepaid expenses and other assets................... 3,295 (4,840)
Accounts payable.................................... (74,105) 74
Accrued expenses and other liabilities.............. (11,843) (102,317)
Deferred revenue.................................... -- (216,000)
----------- -----------
Net cash used in operating activities............................. (1,652,373) (1,042,575)
----------- -----------
Cash flows from investing activities:
Purchases of marketable securities....................... (2,729,831) --
Proceeds from sales of mature marketable securities...... 2,600,195 --
Purchases of equipment, furniture and fixtures........... (393,561) (144,755)
Proceeds from sale of equipment, furniture and fixtures.. 2,200 --
Purchases of patent rights............................... (50,341) (17,879)
----------- -----------
Net cash used in investing activities............................. (571,338) (162,634)
----------- -----------
Cash flows from financing activities:
Principal payments on capital lease obligations.......... (6,028) (1,129)
Proceeds from issuance of common stock................... 64,580 --
----------- -----------
Net cash provided by (used in) financing activities............... 58,552 (1,129)
----------- -----------
Net decrease in cash and cash equivalents......................... (2,165,159) (1,206,338)
Cash and cash equivalents:
Beginning of period...................................... 3,745,851 2,852,285
----------- -----------
End of period............................................ $ 1,580,692 $ 1,645,947
=========== ===========
See accompanying notes to financial statements.
5
MEDI-JECT CORPORATION
NOTES TO FINANCIAL STATEMENTS
(UNAUDITED)
1. BASIS OF PRESENTATION
The accompanying unaudited financial statements have been prepared in
accordance with generally accepted accounting principles for interim
financial information and with the instructions to Form 10-Q and Article 10
of Regulation S-X. Accordingly, they do not include all of the information
and footnotes required by generally accepted accounting principles for
complete financial statements. In the opinion of management, all
adjustments (consisting of normal recurring accruals) considered necessary
for a fair presentation have been included. The accompanying financial
statements and notes should be read in conjunction with the Company's 1998
audited financial statements and notes thereto.
2. INTERIM FINANCIAL STATEMENTS
Operating results for the three month and six month periods ended June 30,
1999, are not necessarily indicative of the results that may be expected
for the year ending December 31, 1999.
3. INVENTORIES
Inventories consist of the following:
December 31, 1998 June 30, 1999
----------------- -------------
Raw Material $132,884 $149,828
Work in-process 95,157 99,933
Finished goods 364,144 124,575
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$592,185 $374,336
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4. SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION
Cash paid for interest during the six month periods ended June 30, 1998
and 1999 was $1,063 and $84, respectively.
Cash paid for taxes during the six month periods ended June 30, 1998 and
1999 was $849 and $250, respectively.
5. REVERSE STOCK SPLIT
On January 28, 1999, the Company declared a one-for-five reverse stock
split. All common shares and per share amounts in the financial statements
have been retroactively restated to give effect to this reverse split.
6
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
Results of Operations
Three and Six Months Ended June 30, 1999 and 1998
Total revenues for the three and six months ended June 30, 1999 were $576,895
and $2,168,883, respectively. These figures reflect a decrease of $178,622, or
24% for the same three month period in 1998 and an increase of $500,393, or 30%
compared to the same six month period in 1998. Product sales decreased $233,066
or 37% in the three month period and $274,590 or 22% in the six month period
ended June 30, 1999, compared to the same periods in the prior year. The
decrease is primarily attributable to a 40% decrease in revenue from product
sales used with human growth hormone in international markets that had strong
sales early in 1998 due to initial market entry. These strong 1998 sales
returned to a more normal level after the first half.
Licensing and product development fee income increased by $54,444 or 42% in the
three month period and $774,983 or 178% in the six month period ended June 30,
1999, as compared to the prior year periods. This increase reflects the funds
received from Schering-Plough Corporation to settle mutual obligations of the
parties under a contract dated January 20, 1998. The Company received a one-
time payment of $783,317 from Schering-Plough in exchange for cancellation of a
product purchase order and as reimbursement for certain non-cancelable
manufacturing expenses. The Company expects that licensing and product
development fee income will fluctuate on a quarterly basis, depending on a
variety of factors; including the timing of execution of potential development
and licensing agreements and the timing, nature and size of fee payments to be
made under existing and new agreements. In addition, since the Company does
not, in general, recognize project-based fee income until related development
work has been performed, quarterly results will fluctuate with the timing of the
Company's research and development efforts.
Cost of sales in the three months and six months ended June 30, 1999 reflect
decreases of $188,686 or 35% and $183,762 or 18% respectively when compared to
prior year periods. The decreases are the result of lower product sales,
primarily products used with human growth hormone applications.
Research and development expenses totaled $525,063 and $ 1,185,585 in the three
and six month periods ended June 30, 1999, respectively. Theses figures reflect
decreases from the prior year periods of $76,107 or 13% and $8,071 or 1%,
respectively due primarily to managed reductions in employee headcount and
overhead spending.
General and administrative expenses totaled $488,526 and $974,209 in the three
and six month periods ended June 30, 1999, respectively. These figures
represent a decrease of $78,289 or 14% and $137,418 or 12% when compared to the
same periods in 1998. The largest component of the decrease is attributable to
staffing reductions which were completed in October 1998.
7
Sales and marketing expenses totaled $224,030 and $488,235 in the three and six
month periods ended June 30, 1999, respectively. These figures reflect an
increase in the three month period of $25,161 or 13% and an increase in the six
month period of $42,523 or 10%. The main components of these increases are
expenses related to a new web site and new sales literature related to the
change to OTC status for our domestic insulin product.
Net other income for the three and six months ended June 30, 1999 decreased by
$62,418 or 85% and $129,805 or 78% relative to the prior year three-month and
six-month periods ending June 30. This decrease primarily reflects a decrease in
interest income attributable to lower average cash balances.
New Product Research and Development
The Company continues to dedicate much of its financial resources and personnel
toward developing new products and technology. The newest injector, the Medi-
Jector VISION, will be released to the market in the fourth quarter of this
year. Beta testing of this new product produced numerous favorable comments
regarding ease of use, light weight and small size.
Development activities on two additional product platforms, the MJ-8 Injector
and the AJ-1 Injector, remain on schedule with prototypes due later this year
and commercialization planned for 2001.
Liquidity and Capital Resources
Cash and cash equivalents totaled $1,645,947 on June 30, 1999, compared to
$2,852,285 on December 31, 1998. This decrease of $1,206,338 results primarily
from a net loss of $1,263,128 adjusted for charges of depreciation and
amortization and changes in operating assets and liabilities. Significant
components were a management-planned decline in inventory of $217,849 in an
effort to reduce working capital offset by a decline in deferred revenue of
$216,000 due to income recognition as development was completed, and a decline
in accrued expenses and other liabilities of $102,317. Purchases of fixed
assets in the amount of $144,755 further lowered the cash balance.
The Company's long term capital requirements will depend on numerous factors,
including the status of the Company's collaborative arrangements, the progress
of the Company's research and development programs and the receipt of revenues
from sales of the Company's products. The Company believes that cash on hand,
interest expected to be earned thereon and anticipated revenues, will meet its
needs through December 1999. In order to meet its capital needs beyond this
period, the Company may be required to raise additional capital through public
or private debt or equity offerings. The Company can provide no assurance,
however, that cash available will be sufficient to meet the Company's needs
during the next six months or beyond due to fluctuations in product development
expenses and receipt of estimated license fees, that the Company will ever
become profitable, or that the Company will be able to raise additional capital
when and if needed, on terms acceptable to the Company, or at all.
8
Impact of the Year 2000
The Company is addressing the issue associated with the programming code in
existing computer systems as the millennium (Year 2000) approaches.
The Company had all internal systems analyzed, reprogrammed and tested by June
30, 1999. To date, confirmations have been received from virtually all of the
Company's vendors indicating that plans are being developed to address
processing of transactions in the Year 2000. There can be no assurance that the
Company will not experience serious unanticipated negative consequences and/or
material costs caused by undetected errors or defects in the technology used in
its internal operating systems, which are composed predominantly of third party
software and hardware technology, or by the failure of vendors to correct their
Year 2000 issues. The majority of the Company's current standard product lines
and manufacturing equipment are not date sensitive and therefore are not
affected by the Year 2000 issues.
The Company has incurred only minimal expense to address the Year 2000 problem
to date and expects that it will incur only minimal expenses in total. The
volume of transactions and operations, processed by the Company's automated
systems, that could potentially be affected can be handled manually or by
outside vendors, if need be, to prevent any interruptions in Company operations.
To mitigate any risk associated with receiving materials from sole source
suppliers, the Company will be purchasing additional reserve inventory related
to selected critical items. Currently, management does not foresee any negative
impact from Year 2000 issues upon the Company's operations.
Reverse Stock Split
On January 28, 1999, the Company declared a one-for-five reverse stock split of
its outstanding common stock, applicable to shareholders of record at close of
trading on January 28, 1999. The reverse split was affected in response to the
Nasdaq National Market listing requirements which require that the Company
maintain a minimum value of public float of $5,000,000 and a minimum bid price
of $1.00 per share. After the reverse split, the Company met the requirements
for continued listing on the Nasdaq Small Cap Market, which require the Company
to maintain a minimum bid price of $1.00 per share and to maintain a minimum
value of public float of $1,000,000. After the reverse split, the Company had
1,424,729 shares of common stock outstanding as fractional shares were paid out
in cash to respective shareholders. All common share and per share amounts in
this report have been retroactively restated to give effect to this reverse
stock split.
Forward Looking Statements
Certain statements included in this Form 10-Q are "forward looking statements"
as defined in the Private Securities Litigation Reform Act of 1995 and are
subject to risks and uncertainties. The words "may," "should," "expect,"
"plan," "anticipate," "believe," "estimate," predict," "intend," "potential," or
"continue" and similar expressions are generally intended to identify forward
looking statements. Factors that may affect future results and performance are
set forth on Exhibit 99, "Cautionary Statements," which was filed with the
United States Securities and Exchange Commission as an Exhibit to Form 10-K,
December 31, 1996.
9
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Market Risk Disclosure
There have been no material changes in reported market risks faced by the
Company since December 31, 1998.
10
PART II - OTHER INFORMATION
Item 1. Legal Proceedings.
None.
Item 2. Changes in Securities
None.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Submission of Matters to a Vote of Securities Holders.
On May 14, 1999, an annual meeting of the shareholders was held at the
offices of the Company. The first item submitted to the shareholders at
the meeting was the election of two directors, Franklin Pass, M.D. and
Stanley Goldberg. Dr. Pass was reelected to the Board of Directors with
votes cast in favor totaling 1,173,667 and votes withheld totaling 35,085.
Mr. Goldberg was reelected to the Board of Directors with votes cast in
favor totaling 1,173,467 and votes withheld totaling 35,285. Continuing
directors of the Company who did not stand for reelection at this meeting
were Kenneth Evenstad, Karl E. Groth, Geoffrey Guy, M.D., and Fred L.
Shapiro, M.D. The second item submitted to the shareholders at the meeting
was the ratification of the Company's independent auditors for the year
ending December 31, 1999. This item was approved with votes cast for
totaling 1,200,103, votes cast against totaling 3,745, abstentions totaling
4,904, and broker non-votes of 0.
Item 5. Other Information.
None
Item 6. Exhibits and Reports on Form 8-K.
(a) Exhibits
3.1 Second Amended and Restated Articles of Incorporation of the
Company.(a)
11
3.2 Second Amended and Restated Bylaws of the Company.(a)
3.3 Certificates of Designations for Series A Preferred Stock.(e)
3.4 Amendment to Second Amended and Related Articles of
Incorporation.(f)
4.1 Form of Certificate for Common Stock.(a)
4.2 Stock Warrant, dated January 25, 1996, issued to Becton
Dickinson and Company.(a)
4.3 Stock Option, dated January 25, 1996, issued to Becton
Dickinson and Company.(a)
4.4 Warrant, dated March 24,1995, issued to Robert Fullerton.(a)
4.5 Warrant, dated March 24,1995, issued to Michael Trautner.(a)
4.6 Preferred Stock, Option and Warrant Purchase Agreement, dated
January 25, 1996, between the Company and Becton Dickinson and
Company (filed herewith as Exhibit 10.7).(a)
4.7 Warrant issued to Elan International Services, Ltd. on November
10, 1998.(e)
10.1 Reserved.
10.3 Security Agreement, dated September 30, 1994, by and between
the Company and Kelsey Lake Limited Partnership and Kerry Lake
Company, a Limited Partnership.(a)
10.4 Reserved.
10.5 Reserved.
10.6 Loan Agreement, dated as of December 22, 1995, by and between
Ethical Holdings plc and the Company, including the related
Promissory Note, dated December 22, 1995, issued to Ethical
Holdings plc.(a)
10.7 Preferred Stock, Option and Warrant Purchase Agreement, dated
January 25, 1996, between the Company and Becton Dickinson and
Company.(a)
10.8* Employment Agreement, dated as of January 1, 1997, between the
Company and Franklin Pass, MD.(c)
10.9* Reserved
10.10* Reserved.
12
10.11* Employment Agreement, dated as of January 3, 1995, between
the Company and Peter Sadowski.(a)
10.12* 1993 Stock Option Plan.(a)
10.13* Form of incentive stock option agreement for use with 1993
Stock Option Plan.(a)
10.14* Form of non-qualified stock option agreement for use with
1993 Stock Option Plan.(a)
10.15* 1996 Stock Option Plan, with form of stock option
agreement.(a)
10.20+ Development and License Agreement between Becton Dickinson
and Company and the Company, effective January 1, 1996
(terminated January 1, 1999). See Exhibit 10.24 (a)
10.21 Office-Warehouse lease with Carlson Real Estate Company, dated
February 11, 1997.(b)
10.22* 1998 Stock Option Plan for Non-Employee Directors.(d)
10.23* Letter consulting agreement dated February 20, 1998 between
the Company and Geoffrey W. Guy.(d)
10.24# Agreement with Becton Dickinson and Company dated January 1,
1999.(e)
10.25 Securities Purchase Agreement with Elan International Services,
Ltd. dated November 10, 1998.(e)
10.26# License & Development Agreement with Elan Corporation, plc,
dated November 10, 1998.(e)
27 Financial Data Schedule
99 Cautionary Statement.(b)
* Indicates management contract or compensatory plan or arrangement.
+ Pursuant to Rule 406 of the Securities Act of 1933, as amended,
confidential portions of Exhibit 10.20 were deleted and filed separately
with the Securities and Exchange Commission pursuant to a request for
confidential treatment, which was subsequently granted by the Securities
and Exchange Commission.
# Pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended,
confidential portions of Exhibits 10.24 and 10.26 were deleted and filed
separately with the Securities and Exchange Commission pursuant to a
request for confidential treatment, which was subsequently granted by the
Securities and Exchange Commission.
(a) Incorporated by reference to the Company's Registration Statement on Form
S-1 (File No. 333-6661), filed with the Securities and Exchange Commission
on October 1, 1996.
(b) Incorporated by reference to the Company's Form 10-K for the year ended
December 31, 1996.
13
(c) Incorporated by reference to the Company's Form 10-Q for the quarter ended
March 31, 1997.
(d) Incorporated by reference to the Company's Form 10-K for the year ended
December 31, 1997.
(e) Incorporated by reference to the Company's Form 10-K for the year ended
December 31,1998.
(f) Filed herewith.
(b) Reports on Form 8-K
No reports on Form 8-K were filed during the quarter ended June 30,
1999.
14
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.
MEDI-JECT CORPORATION
August 11, 1999 /s/ Franklin Pass
- ---------------------------------------- -----------------------------------
Date Franklin Pass, MD, Chairman/CEO
August 11, 1999 /s/ Lawrence M. Christian
- ---------------------------------------- -----------------------------------
Date Lawrence M. Christian, Vice
President- Finance & Administration
/CFO
(principal financial & accounting
officer)
15