<PAGE>
SECURITIES AND EXCHANGE COMMISSION
Washington, DC
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 September 30, 1996
------------------
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: 0-28748
--------
TRI-POINT MEDICAL CORPORATION
---------------------------------------
(Exact name of registrant as specified in its charter)
Delaware 56-1959623
---------------- ---------------------
(State or other (I.R.S. Employer
jurisdiction Identification No.)
of incorporation or
organization)
5265 Capital Boulevard, Raleigh, North Carolina 27616
------------------------------------------------------
(Address of principal executive offices) (Zip Code)
(919) 876-7800
------------------------------------------------
(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 No X
----- -----
Indicate the number of shares outstanding of each of the issuer's classes
of common stock, as of the latest practicable date.
Class Outstanding at November 8, 1996
----- -------------------------------
Common Stock, par value $0.01 per share 12,150,000
<PAGE>
TRI-POINT MEDICAL CORPORATION
INDEX
<TABLE>
<CAPTION>
Page Number
-----------
<S> <C> <C>
PART I: FINANCIAL INFORMATION
Item 1. Financial Statements
Balance Sheet as of September 30, 1996
(unaudited) and December 31, 1995............................ 3
Statement of Operations (unaudited) for
the three months ended September 30,
1996 and 1995 and for the nine months
ended September 30, 1996 and 1995............................ 4
Statement of Cash Flows (unaudited) for
the nine months ended September 30,
1996 and 1995................................................ 5
Notes to Financial Statements................................. 6
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........................11
</TABLE>
2
<PAGE>
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
Tri-Point Medical Corporation
Balance Sheet
(In thousands, except for share data)
<TABLE>
<CAPTION>
September 30, December 31,
1996 1995
---- ----
Assets (Unaudited)
<S> <C> <C>
Current assets:
Cash and cash equivalents $ 19,392 $ 20
Accounts receivable 34 266
Inventories 155 119
Prepaid expenses 427 27
------------- ---------------
Total current assets 20,008 432
------------- ---------------
Furniture, fixtures and equipment 726 418
Less - accumulated depreciation and amortization (170) (142)
------------- ---------------
556 276
------------- ---------------
Intangible assets, net of accumulated amortization 233 200
------------- ---------------
Total assets $ 20,797 $ 908
============= ===============
Liabilities, Stockholders' Equity and Partners' Capital (Deficit)
Accounts payable $ 769 $ 514
Accrued expenses 395 28
Deferred revenue 1,575 78
Payable to Caratec, L.L.C. 5 195
Capital lease obligations 3 12
------------- ---------------
Total current liabilities 2,747 827
Notes payable to Sharpoint Development Corporation - 10,062
Accrued interest payable to Sharpoint Development Corporation - 843
Capital lease obligations 26 26
------------- ---------------
Total liabilities 2,773 11,758
------------- ---------------
Stockholders' Equity and Partners' Capital (Deficit)
Preferred Stock, $.01 par value. Authorized 2,000,000
shares; none issued or outstanding. - -
Common Stock, $.01 par value. Authorized 35,000,000 shares;
issued and outstanding 12,150,000 shares. 121 -
Additional paid-in capital 33,612
Partners' capital (deficit) - (10,850)
Accumulated deficit (14,633) -
Deferred compensation on stock options (1,076) -
------------- ---------------
Total stockholders' equity and partners' capital (deficit) 18,024 (10,850)
------------- ---------------
Total liabilities, stockholders' equity and partners' capital
(deficit) $ 20,797 $ 908
============= ===============
</TABLE>
The accompanying notes are an integral part of these financial statements.
3
<PAGE>
Tri-Point Medical Corporation
Statement of Operations
(Unaudited)
(In thousands, except per share data)
<TABLE>
<CAPTION>
Three Months Nine Months
Ended September 30, Ended September 30,
1996 1995 1996 1995
---- ---- ---- ----
<S> <C> <C> <C> <C>
Product sales $ 106 $ 221 $ 298 $ 839
License and product development revenues - - 3,500 -
-------- -------- -------- --------
Total revenues 106 221 3,798 839
-------- -------- -------- --------
Cost of products sold 119 128 292 389
-------- -------- -------- --------
Gross profit (13) 93 3,506 450
-------- -------- -------- --------
Research, development and regulatory affairs expenses 817 365 2,156 1,113
Selling and administrative expenses 965 302 1,980 930
Exchange of rights with Caratec, L.L.C. 14,210 - 14,210 -
Payments to Caratec, L.L.C. 5 113 293 288
-------- -------- -------- --------
Total operating expenses 15,997 780 18,639 2,331
-------- -------- -------- --------
Loss from operations (16,010) (687) (15,133) (1,881)
Interest expense to Sharpoint Development
Corporation, net of interest income (24) 215 69 611
-------- -------- -------- --------
Net loss $ (15,986) $ (902) $ (15,202) $ (2,492)
======== ======== ======== ========
Shares used in computation of net
loss per share 9,739 10,150 10,012 10,150
======== ======== ======== ========
Net loss per share $ (1.64) $ (0.09) $ (1.52) $ (0.25)
==== ==== ==== ====
</TABLE>
The accompanying notes are an integral part of these financial statements.
4
<PAGE>
Tri-Point Medical Corporation
Statement of Cash Flows
(Unaudited)
(In thousands)
<TABLE>
<CAPTION>
Nine Months Ended September 30,
1996 1995
---- ----
<S> <C> <C>
Cash flows from operating activities:
Net loss $ (15,202) $ (2,492)
Adjustments to reconcile net loss to net cash
provided (used) by operating activities:
Amortization expense 8 50
Depreciation expense 41 35
Amortization of deferred compensation on stock options 424 -
Exchange of rights with Caratec, L.L.C. 14,210 -
Net loss on disposals of fixed assets 12 -
Change in accounts receivable 232 70
Change in inventories (36) 25
Change in prepaid expenses (400) 11
Change in accounts payable and accrued expenses 622 (66)
Change in deferred revenue 1,497 159
Change in accrued payable to Caratec, L.L.C. (190) 176
Change in accrued interest due to Sharpoint
Development Corporation 138 611
------------ ------------
Net cash provided (used) by operating activities 1,356 (1,421)
------------ ------------
Cash flows from investing activities:
Additions to furniture, fixtures and equipment (332) (76)
Additions to intangible assets (41) (32)
------------ ------------
Net cash used by investing activities (373) (108)
------------ ------------
Cash flows from financing activities:
Proceeds from notes payable to Sharpoint
Development Corporation 440 1,470
Net proceeds from sale of common stock 17,958 -
Change in capital lease obligation (9) 35
------------ ------------
Net cash provided by financing activities 18,389 1,505
------------ ------------
Increase (decrease) in cash 19,372 (24)
Cash at beginning of period 20 30
------------ ------------
Cash at end of period $ 19,392 $ 6
============ ============
</TABLE>
Non-Cash Transactions:
On March 29, 1996, notes payable of $10,502 and related accrued interest of
$980 was converted to partners' capital.
The accompanying notes are an integral part of these financial statements.
5
<PAGE>
Tri-Point Medical Corporation
Notes to Financial Statements
(Unaudited)
1. Organization and Operations
Tri-Point Medical Corporation (the "Company") develops, commercializes and
manufactures medical adhesive products based on its proprietary cyanoacrylate
technology. The Company was incorporated as a wholly-owned subsidiary of Tri-
Point Medical L.P.(the "Partnership") on February 20, 1996. From May 10, 1990 to
February 29, 1996, the business of the Company was conducted by the Partnership.
On March 1, 1996, substantially all of the assets and liabilities of the
Partnership, except for the indebtedness to Sharpoint Development Corporation
("Sharpoint"), the Partnership's general partner, were transferred to the
Company in exchange for one share of Common Stock. On the effective date of the
Company's initial public offering, September 25, 1996, obligations of and
interests in the Partnership were contributed to the Company in exchange for an
aggregate of 9,600,000 shares of Common Stock.
2. Significant Accounting Policies
The significant accounting policies followed by the Company for interim
financial reporting are consistent with the accounting policies followed for
annual financial reporting. These unaudited financial statements have been
prepared in accordance with Rule 10-01 of Regulation S-X, and in management's
opinion, all adjustments of a normal recurring nature necessary for a fair
presentation have been included. Accordingly, they do not include all of the
information and footnotes required by generally accepted accounting principles
for complete financial statements and should be read in conjunction with the
financial statements and notes thereto for the year ended December 31, 1995
included in the Company's Registration Statement on Form S-1 (Registration
Statement File No. 333-5425) and related prospectus for the Company's initial
public offering of its Common Stock dated September 25, 1996.
The results of operations for the three and nine month periods ended September
30, 1996 are not necessarily indicative of the results to be expected for the
full year ended December 31, 1996.
3. Inventories
Inventories include the following:
<TABLE>
<CAPTION>
September 30, December 31,
1996 1995
(In thousands)
<S> <C> <C>
Packaging $ 38 $ 35
Raw materials 29 23
Work-in-process 64 45
Finished goods 24 16
--------- --------
$ 155 $ 119
--------- --------
</TABLE>
4. Net Loss Per Share
Net loss per share is computed using the weighted average number of common and
common equivalent shares outstanding during the periods. Common equivalent
shares consist of stock options using the treasury stock method. Common
equivalent shares from stock options are excluded from the computation if their
effect is antidilutive, except that pursuant to the requirements of the
Securities and Exchange Commission, pro forma common and common equivalent
shares deemed outstanding immediately prior to the issuance of common shares in
the initial public offering have been included as if they were outstanding for
all periods prior to June 30, 1996.
6
<PAGE>
Tri-Point Medical Corporation
Notes to Financial Statements
(Unaudited)
5. Taxes
No federal or state income tax provision has been provided for income tax
purposes, as the Company does not expect to have a tax liability for the year
ending December 31, 1996. Additionally, the deferred tax asset that might be
recorded as a result of net operating losses under Statement of Financial
Accounting Standards No. 109, "Accounting for Income Taxes," would be offset by
a related valuation allowance because realization of the asset is not probable.
Accordingly, no benefit has been recorded.
6. Stockholders' Equity
On March 29, 1996, the Partnership's long-term debt and accrued interest held by
Sharpoint was contributed to the Partnership as $11,483,000 of partners'
capital. On September 25, 1996, the effective date of the Company's initial
public offering, obligations of and interests in the Partnership were
contributed to the Company in exchange for an aggregate of 9,600,000 shares of
Common Stock. Included in this exchange was the contribution by Caratec, L.L.C.
("Caratec"), a limited partner of the Partnership, of its right to receive
various payments from the Partnership and its limited partnership interest for
1,776,250 shares of Common Stock. The transaction with Caratec resulted in a
non-cash expense of $14,210,000, which equals the difference between the value
of Common Stock issued to Caratec and its basis in the Partnership. The
resulting charge to accumulated deficit was offset by a credit to additional
paid-in capital.
7
<PAGE>
Item 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
The following discussion should be read in conjunction with the unaudited
financial statements and notes thereto included in Part I--Item 1 of this Form
10-Q and the audited financial statements and notes thereto and Management's
Discussion and Analysis of Financial Condition and Results of Operations for the
year ended December 31, 1995 contained in the Company's Registration Statement
on Form S-1 (Registration Statement No. 333-5425) and related prospectus for the
Company's initial public offering of its Common Stock dated September 25, 1996.
This report contains, in addition to historical information, forward-looking
statements that involve risks and uncertainties. These forward-looking
statements include statements regarding the Company's development, growth and
expansion plans and the sufficiency of the Company's liquidity and capital.
Such statements are based on management's current expectations and are subject
to a number of uncertainties and risks that could cause actual results to differ
materially from those described in the forward-looking statements. Factors that
may cause such a difference include, but are not limited to, those described
under "Risk Factors" in the Company's prospectus dated September 25, 1996.
Overview
Since its inception in May 1990, the Company has been developing,
commercializing and manufacturing medical adhesive products for use in wound
closure on humans and animals. The Company's products are based on its
proprietary cyanoacrylate technology and a substantial portion of the Company's
historical expenses has consisted of research and development and clinical trial
expenses. Through September 25, 1996, the effective date of the Company's
initial public offering, the Company has funded its operations with cash
borrowed from Sharpoint Development Corporation ("Sharpoint"), sales of
Octyldent(R) and Nexaband(R) products, and license and product development
revenues from marketing partners.
The Company has been unprofitable since its inception and has incurred net
losses in each year, including net losses of approximately $6,972,000 for the
year ended December 31, 1995. These losses have resulted in accumulated net
losses of approximately $15,692,000 as of September 30, 1996. These accumulated
losses do not include a one-time non-cash charge of $14,210,000 during the three
months ended September 30, 1996 which was offset by a credit to additional paid-
in capital. The Company anticipates that it will incur increased losses for the
next several years, as it expects its research and development expenses to
increase in order to fund additional clinical trials and develop new products.
The Company also expects to incur additional capital expenditures to expand its
manufacturing capabilities. The amount of future net losses and time required by
the Company to reach profitability are highly uncertain. The Company's ability
to generate significant revenue and become profitable will depend on its success
in commercializing TraumaSeal(TM), including the receipt of all regulatory
clearances and approvals, expanding its manufacturing capabilities, developing
new products and entering into additional marketing agreements and the ability
of its marketing partners to commercialize successfully products incorporating
the Company's technologies. No assurance can be given that the Company will
generate significant revenue or become profitable on a sustained basis, if at
all.
Results of Operations
Total revenues were $106,000 for the three months ended September 30, 1996
compared to $221,000 for the three months ended September 30, 1995. For the nine
months ended September 30, 1996, total revenues were $3,798,000 compared to
$839,000 for the same period in 1995. Revenues from product sales for the nine
months ended September 30, 1996 were $298,000 compared to $839,000 for the same
period in 1995. License and product development revenues were $3,500,000 for the
nine months ended September 30, 1996 compared to $0 for the same period in 1995.
This increase was the result of the receipt of $3,500,000 in license and product
development revenues under the supply and distribution agreement for
TraumaSeal(TM) entered into with Ethicon, Inc. ("Ethicon") in March 1996. The
decreases in product sales were primarily a result of decreased sales volume of
Octyldent(R) as a result of the inventory build-up by the Company's marketing
partner during 1995.
8
<PAGE>
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
Cost of products sold were $119,000 for the three months ended September 30,
1996 compared to $128,000 for the three months ended September 30, 1995, a
decrease of 7%. Cost of products sold as a percentage of product sales increased
to 112% in the three months ended September 30, 1996 compared to 58% during the
same period of 1995. For the nine months ended September 30, 1996, cost of
products sold was $292,000 compared to $389,000 for the same period in 1995.
Cost of products sold as a percentage of product sales increased to 98% for the
nine months ended September 30, 1996 compared to 46% during the same period of
1995. These decreases in costs of products sold were primarily a result of
decreased sales volume of Octyldent(R). The increases in costs of products sold
as a percentage of product sales were primarily a result of the decreased sales
volume of Octyldent(R), resulting in the fixed portion of cost of products sold
being allocated over lower sales, and decreased manufacturing efficiencies and
additional costs associated with the expansion of the Company's manufacturing
capabilities.
Operating expenses were $15,997,000 for the three months ended September 30,
1996 compared to $780,000 for the three months ended September 30, 1995. For the
nine months ended September 30, 1996, operating expenses were $18,639,000
compared to $2,331,000 for the same period in 1995. Included in operating
expenses during the three months ended September 30, 1996 was a one-time non-
cash charge of $14,210,000 related to the exchange by Caratec, L.L.C.
("Caratec"), a former limited partner of the Company's predecessor, Tri-Point
Medical L.P. (the "Partnership"), of its right to receive various payments from
the Partnership and its limited partnership interest for Common Stock of the
Company. Excluding the exchange with Caratec, total operating expenses increased
by $1,007,000 and $2,098,000 for the three months and nine months ended
September 30, 1996, respectively. These increases related to costs associated
with the conduct of clinical trials for TraumaSeal(TM), as well as amortization
of deferred compensation related to employee and director stock options.
Net interest income was $24,000 for the three months ended September 30, 1996
compared to net interest expense of $215,000 for the three months ended
September 30, 1995. For the nine months ended September 30, 1996, net interest
expense was $69,000 compared to $611,000 for the same period in 1995. This
decrease in net interest expense was primarily a result of an agreement to cease
accruing interest as of March 1, 1996 on long-term debt in connection with the
incorporation of the Company on February 20, 1996 and the subsequent transfer on
March 1, 1996 of all assets and liabilities of the Partnership to the Company,
except for the indebtedness to Sharpoint, the Partnership's general partner. In
addition, during the three months and nine months ended September 30, 1996, the
Company had interest income from cash equivalents.
Liquidity and Capital Resources
The Company's cash and cash equivalents totaled $19,392,000 at September 30,
1996, an increase of $19,372,000 from December 31, 1995. On September 30, 1996,
the Company completed its initial public offering of 3,000,000 shares of Common
Stock, of which 2,550,000 shares were sold by the Company, generating proceeds
of approximately $18,972,000 (after deducting underwriting discounts). In April
1996, the Company received an additional $4,500,000 related to the supply and
distribution agreement for the TraumaSeal(TM) product entered into with Ethicon
on March 20, 1996. In September 1996, Ethicon advanced the Company approximately
$506,000 for direct costs incurred in connection with clinical studies of the
TraumaSeal(TM) product, which have been classified as deferred revenue and will
be credited against future royalties to be paid by Ethicon.
Cash provided by operating activities was $1,356,000 for the nine months ended
September 30, 1996. The Company used cash of $1,421,000 for operating
activities during the same period of 1995. This decrease in cash used in
operations was due primarily to the receipt of $4,500,000 under the supply and
distribution agreement for TraumaSeal(TM).
Cash used for investing activities was $373,000 and $108,000 for the nine months
ended September 30, 1996 and 1995, respectively. The cash was used to acquire
capital equipment, as well as to obtain and establish patents.
9
<PAGE>
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
Cash provided by financing activities was $18,389,000 and $1,505,000 for the
nine months ended September 30, 1996 and 1995, respectively. The Company's
financing activities during the nine months ended September 30, 1996 were its
initial public offering and borrowings from Sharpoint. During the nine months
ended September 30, 1995, the Company's only financing activities were
borrowings from Sharpoint.
The Company believes that existing cash and cash equivalents, including the
proceeds from the initial public offering, will be sufficient to finance its
capital requirements for at least 24 months. The Company's future capital
requirements, however, will depend on numerous factors, including (i) the
progress of its research and product development programs, including clinical
studies, (ii) the effectiveness of product commercialization activities and
marketing agreements, including the development and progress of sales and
marketing efforts and manufacturing operations, (iii) the ability of the Company
to maintain existing marketing agreements and establish and maintain new
marketing agreements, (iv) the costs involved in preparing, filing, prosecuting,
defending and enforcing intellectual property rights and complying with
regulatory requirements and (v) the effect of competing technological and market
developments. If the Company's currently available funds and internally
generated cash flow are not sufficient to satisfy its financing needs, the
Company will be required to seek additional funding through bank borrowings and
additional public or private sales of its securities, including equity
securities, or through other arrangements with marketing partners. The Company
has no credit facility or other committed sources of capital. There can be no
assurance that additional funds, if required, will be available to the Company
on favorable terms.
10
<PAGE>
PART II. OTHER INFORMATION
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
(a) Exhibits.
11 Computation of pro forma net loss per share (see Note
4 to Notes to Financial Statements in Item I of this
Form 10-Q).
27 Financial Data Schedule.
(b) Reports on Form 8-K.
None.
11
<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.
TRI-POINT MEDICAL CORPORATION
Date: November 13, 1996 By: /s/ Robert V. Toni
-------------------------------------------
Robert V. Toni
President and Chief Executive Officer
Date: November 13, 1996 By: /s/ J. Blount Swain
-------------------------------------------
J. Blount Swain
Vice President and Chief Financial Officer
(Principal Financial and Accounting Officer)
<PAGE>
EXHIBIT 11
TRI-POINT MEDICAL CORPORATION
COMPUTATION OF PRO FORMA NET LOSS PER SHARE
(UNAUDITED)
(in thousands, except per share data)
<TABLE>
<CAPTION>
Three Months Ended Nine Months Ended
September 30, September 30, September 30, September 30,
1996 1995 1996 1995
---- ---- ---- ----
<S> <C> <C> <C> <C>
Weighted average common shares
outstanding for the period 9,739 9,600 10,012 9,600
Common equivalent shares pursuant to
Staff Accounting Bulletin #83(1) - 550 - 550
------------ ------------ ------------ ------------
Shares used in computing net loss per share 9,739 10,150 10,012 10,150
============ ============ ============ ============
Net loss $ (15,986) $ (902) $ (15,202) $ (2,492)
============ ============ ============ ============
Net loss per share $ (1.64) $ (0.09) $ (1.52) $ (0.25)
============ ============ ============ ============
</TABLE>
(1) Issuance of common stock options at prices below the expected public
offering price within 12 months of the effective date of the offering, have been
included as common stock equivalents as if they had been issued as common stock
for all periods prior to June 30, 1996.
<TABLE> <S> <C>
<PAGE>
<ARTICLE> 5
<S> <C>
<PERIOD-TYPE> 9-MOS
<FISCAL-YEAR-END> DEC-31-1996
<PERIOD-END> SEP-30-1996
<CASH> 19,392,125
<SECURITIES> 0
<RECEIVABLES> 34,200
<ALLOWANCES> 0
<INVENTORY> 154,788
<CURRENT-ASSETS> 20,008,334
<PP&E> 726,311
<DEPRECIATION> (169,918)
<TOTAL-ASSETS> 20,797,789
<CURRENT-LIABILITIES> 2,747,838
<BONDS> 0
0
0
<COMMON> 121,500
<OTHER-SE> 17,902,552
<TOTAL-LIABILITY-AND-EQUITY> 20,797,789
<SALES> 298,391
<TOTAL-REVENUES> 3,798,391
<CGS> 292,427
<TOTAL-COSTS> 292,427
<OTHER-EXPENSES> 18,707,242
<LOSS-PROVISION> 0
<INTEREST-EXPENSE> 0
<INCOME-PRETAX> (15,201,278)
<INCOME-TAX> 0
<INCOME-CONTINUING> (15,201,278)
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> (15,201,278)
<EPS-PRIMARY> (1.52)
<EPS-DILUTED> (1.52)
</TABLE>
