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 March 31, 1997
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
CLOSURE MEDICAL CORPORATION
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(Exact name of registrant as specified in its charter)
Delaware 56-1959623
- ---------------------------- ----------------
(State or other jurisdiction (I.R.S. Employer
of incorporation or Identification No.)
organization)
5265 Capital Boulevard, Raleigh, North Carolina 27616
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(Address of principal executive offices) (Zip Code)
(919) 876-7800
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(Registrant's telephone number, including area code)
Indicate by check mark whether the registrant (1) has filed all reports
required to be filed by Section 13 or 15(d) of the Securities Exchange Act of
1934 during the preceding 12 months (or for such shorter period that the
registrant was required to file such reports), and (2) has been subject to such
filing requirements for the past 90 days.
Yes |X| No |_|
Indicate the number of shares outstanding of each of the issuer's classes
of common stock, as of the latest practicable date.
Class Outstanding at May 8, 1997
----- --------------------------
Common Stock, par value $0.01 per share 13,185,387
CLOSURE MEDICAL CORPORATION
INDEX
Page Number
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PART I: FINANCIAL INFORMATION
Item 1. Financial Statements
Balance Sheet as of March 31, 1997 (unaudited) and
December 31, 1996............................................. 3
Statement of Operations (unaudited) for the three months
ended March 31, 1997 and 1996................................. 4
Statement of Cash Flows (unaudited) for the three months ended
March 31, 1997 and 1996....................................... 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
2
PART 1. FINANCIAL INFORMATION
Item 1. Financial Statements
Closure Medical Corporation
Balance Sheet
(In thousands, except for share data)
March 31, December 31,
1997 1996
-------- --------
Assets (Unaudited)
Current assets:
Cash and cash equivalents $ 10,918 $ 13,024
Short-term investments 5,101 4,627
Accounts receivable 135 67
Inventories 150 112
Prepaid expenses 466 388
-------- --------
Total current assets 16,770 18,218
-------- --------
Furniture, fixtures and equipment 1,255 851
Less - accumulated depreciation and amortization (210) (179)
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1,045 672
-------- --------
Long-term investments -- 409
-------- --------
Intangible assets, net of accumulated amortization 233 213
-------- --------
Total assets $ 18,048 $ 19,512
======== ========
Liabilities and Stockholders' Equity
Accounts payable $ 691 $ 566
Accrued expenses 219 396
Deferred revenue 2,054 2,069
Capital lease obligations 9 12
-------- --------
Total current liabilities 2,973 3,043
Capital lease obligations 14 14
-------- --------
Total liabilities 2,987 3,057
-------- --------
Stockholders' Equity
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 12,155,029 shares. 122 122
Additional paid-in capital 33,605 33,579
Accumulated deficit (17,742) (16,246)
Deferred compensation on stock options (924) (1,000)
-------- --------
Total stockholders' equity 15,061 16,455
-------- --------
Total liabilities and stockholders' equity $ 18,048 $ 19,512
======== ========
The accompanying notes are an integral part of these financial statements.
3
Closure Medical Corporation
Statement of Operations
(Unaudited)
(In thousands, except per share data)
Three Months
Ended March 31,
1997 1996
-------- --------
Product sales $ 208 $ 162
License and product development revenues -- 3,500
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Total revenues 208 3,662
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Cost of products sold 151 136
-------- --------
Gross profit and license and product development
revenues 57 3,526
-------- --------
Research, development and regulatory affairs expenses 750 651
Selling and administrative expenses 1,062 626
Payments to Caratec, L.L.C -- 287
-------- --------
Total operating expenses 1,812 1,564
-------- --------
Income (loss) from operations (1,755) 1,962
Interest expense to Sharpoint Development
Corporation (1) (134)
Investment and interest income 260 --
-------- --------
Net income (loss) $ (1,496) $ 1,828
======== ========
Shares used in computation of net income
(loss) per common share 12,210 10,150
======== ========
Net income (loss) per common share $ (0.12) $ 0.18
======== ========
The accompanying notes are an integral part of these financial statements.
4
Closure Medical Corporation
Statement of Cash Flows
(Unaudited)
(In thousands)
Three Months Ended March 31,
1997 1996
-------- -------
Cash flows from operating activities:
Net income (loss) $ (1,496) $ 1,828
Adjustments to reconcile net income (loss) to
net cash provided (used) by
operating activities:
Amortization expense 2 3
Depreciation expense 32 11
Amortization of deferred compensation on stock options 76 --
Net loss on disposals of fixed assets 5 11
Change in accounts receivable (68) 154
Change in inventories (38) 35
Change in prepaid expenses (78) (45)
Change in accounts payable and accrued expenses (52) 440
Change in deferred revenue (15) 992
Change in accrued payable to Caratec, L.L.C -- 92
Change in accrued interest due to Sharpoint
Development Corporation -- 138
-------- -------
Net cash provided (used) by operating activities (1,632) 3,659
-------- -------
Cash flows from investing activities:
Additions to furniture, fixtures and equipment (409) (23)
Additions to intangible assets (23) (2)
Purchases of investments (1,746) --
Proceeds from the sale of investments 1,681 --
-------- -------
Net cash used by investing activities (497) (25)
-------- -------
Cash flows from financing activities:
Proceeds from notes payable to Sharpoint
Development Corporation -- 440
Net proceeds from sale of common stock 26 --
Change in capital lease obligation (3) (3)
-------- -------
Net cash provided by financing activities 23 437
-------- -------
Increase (decrease) in cash and cash equivalents (2,106) 4,071
Cash and cash equivalents at beginning of period 13,024 20
-------- -------
Cash and cash equivalents at end of period $ 10,918 $ 4,091
======== =======
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
Closure Medical Corporation
Notes to Financial Statements
(Unaudited)
1. Organization and Operations
Closure Medical Corporation ("Closure" or the "Company"), formerly named
Tri-Point Medical Corporation, develops, commercializes and manufactures medical
tissue cohesive products based on its proprietary cyanoacrylate technology
utilized primarily for human and veterinary wound closure. The Company was
incorporated in Delaware on February 20, 1996. From May 10, 1990 to February 29,
1996, the business of the Company was conducted by Tri-Point Medical L. P. (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, 1996
included in the Company's Annual Report on Form 10-K for the year ended December
31, 1996.
The results of operations for the three month period ended March 31, 1997 are
not necessarily indicative of the results to be expected for the full year ended
December 31, 1997.
Statement of Financial Accounting Standards No. 128, "Accounting for Earnings
Per Share" ("EPS") ("SFAS 128"), was issued in February 1997. SFAS 128
establishes and simplifies the standards for computing earnings per share
previously found in APB Opinion No. 15, "Earnings Per Share," and makes them
comparable to international EPS standards. SFAS 128 is effective for financial
statements for fiscal years ending after December 15, 1997, including interim
periods. Closure believes that the adoption of SFAS 128 will not have a material
impact on the Company's financial position or results of operations.
3. Inventories
Inventories included the following:
March 31, December 31,
1997 1996
(In thousands)
Packaging $ 34 $ 25
Raw materials 15 23
Work-in-process 63 25
Finished goods 38 39
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$150 $112
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6
Closure Medical Corporation
Notes to Financial Statements
(Unaudited)
4. Loss Per Share
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, common and common equivalent shares issued
from January 1, 1995 through the effective date of the Company's initial public
offering on September 25, 1996 (see Note 1 above) have been included in the
computation using the treasury stock method as if they were outstanding for all
periods prior to June 30, 1996.
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, 1997. 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 likely.
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 equaled 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. Contingencies
In March 1997, the Company was served with a complaint filed in the Superior
Court Department of the Trial Court of the Commonwealth of Massachusetts
alleging personal injury as a result of negligence by the Company in the design,
testing and distribution of Avacryl, an n-butyl cyanoacrylate used in a medical
procedure in 1993 as part of a clinical trial conducted by the Company pursuant
to an Investigational Device Exemption. The Company's insurer has assumed the
defense of this lawsuit. The Company has provided certain information in
response to the discovery process but has not yet answered the complaint.
Accordingly, the Company is not yet able to assess its potential exposure in
this case. However, based on the limited information available to it, the
Company intends to vigorously defend the lawsuit and management believes the
outcome of this case will not have a material adverse effect on the Company's
financial position or results of operations.
8. Subsequent Event
In April 1997, the Company completed a follow-on public offering. An aggregate
of 1,725,000 shares (including the over-allotment option) were sold at $12.875
per share, of which 1,025,000 shares were sold by the Company and 700,000 shares
were sold by a shareholder. Aggregate proceeds to the Company, before offering
expenses, were approximately $12,377,000.
7
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, 1996 contained in the Company's Annual Report on Form
10-K for the year ended December 31, 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, the early stage of
commercialization of the Company's products, the need for regulatory approval
and effects of governmental regulation, technological uncertainties, dependence
on marketing partners and dependence on patents and trade secrets, as well as
those described under "Factors Affecting the Company's Business, Operating
Results and Financial Condition" in the Company's Annual Report on Form 10-K for
the year ended December 31, 1996 filed with the Securities and Exchange
Commission.
Overview
Since its inception in May 1990, the Company has been developing,
commercializing and manufacturing medical tissue cohesive products for use in
wound closure in 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 had 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. On September 30, 1996, the Company completed
its initial public offering, issuing 2,550,000 shares of Common Stock and
generating net proceeds of approximately $17,926,000. On April 2, 1997, the
Company completed a follow-on public offering, issuing 1,025,000 shares of
Common Stock and generating proceeds, before offering expenses, of approximately
$12,377,000.
The Company has been unprofitable since its inception and has incurred net
losses in each year, including a net loss of approximately $16,814,000 for the
year ended December 31, 1996, or $2,604,000 excluding a one-time non-cash charge
of $14,210,000 (see Note 6 to Notes to Financial Statements in Item 1 of this
Form 10-Q). The Company anticipates that its recurring operating expenses will
increase for the next several years, as it expects its research and development
expenses to increase in order to develop new products and fund additional
clinical trials. The Company also expects to incur additional capital
expenditures to expand its manufacturing capabilities. The Company expects to
continue to incur a loss in 1997 and may incur losses in subsequent years,
although 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 on 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 $208,000 for the three months ended March 31, 1997, compared
to $3,662,000 for the three months ended March 31, 1996. Revenues from product
sales for the three months ended March 31, 1997 were $208,000, compared to
$162,000 for the same period in 1996. License and product development revenues
were $0 for the three months ended March 31, 1997, compared to $3,500,000 for
8
Item 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
the same period in 1996. In March 1996, the Company received $3,500,000 in
license and product development revenues under the supply and distribution
agreement for TraumaSeal(TM) entered into with Ethicon, Inc. ("Ethicon"). The
increase in product sales was primarily a result of increased sales volume of
Octyldent(R) .
Cost of products sold were $151,000 for the three months ended March 31, 1997,
compared to $136,000 for the three months ended March 31, 1996, an increase of
11%. Cost of products sold as a percentage of product sales decreased to 73% in
the three months ended March 31, 1997, compared to 84% during the same period of
1996. The increase in cost of product sold was primarily a result of increased
sales volume of Octyldent(R). The decrease in cost of products sold as a
percentage of product sales was also primarily a result of the increased sales
volume of Octyldent(R), resulting in the fixed portion of cost of products sold
being allocated over higher sales.
Operating expenses were $1,812,000 for the three months ended March 31, 1997,
compared to $1,564,000 for the three months ended March 31, 1996, an increase of
16%. This increase was primarily due to increased staffing, as well as the
additional administrative costs associated with supporting a public company,
such as directors' and officers' liability insurance, investor relations and
amortization of deferred compensation related to employee and director stock
options.
Interest expense was $1,000 for the three months ended March 31, 1997, compared
to $134,000 for the three months ended March 31, 1996. This decrease in interest
expense was primarily a result of the long-term debt, including accrued
interest, of the Partnership held by Sharpoint being contributed to the
Partnership as $11,483,000 of partners' capital as of March 29, 1996. On
September 25, 1996, this partners' capital was exchanged for shares of Common
Stock of the Company.
Investment and interest income was $260,000 for the three months ended March 31,
1997, compared to $0 for the same period of 1996. This increase resulted from
interest earned from higher average cash and investment balances resulting from
the Company's receipt of net proceeds of its initial public offering in
September 1996.
Liquidity and Capital Resources
The Company's cash and cash equivalents and short-term investments totaled
$16,019,000 at March 31, 1997, compared to $17,651,000 at December 31, 1996. 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 net proceeds of approximately $17,926,000. In March 1996,
the Company received $4,500,000 related to the supply and distribution agreement
for TraumaSeal(TM) entered into with Ethicon. Since September 1996, Ethicon has
advanced the Company approximately $1,000,000 for direct costs incurred in
connection with clinical studies of TraumaSeal(TM) , which have been classified
as deferred revenue and will be credited against future royalties expected to be
paid by Ethicon.
Cash used by operating activities was $1,632,000 for the three months ended
March 31, 1997, compared to cash provided by operating activities of $3,659,000
during the same period of 1996, primarily due to the receipt of $4,500,000 under
the supply and distribution agreement for TraumaSeal(TM) in 1996.
Cash used for investing activities was $497,000 and $25,000 for the three months
ended March 31, 1997 and 1996, respectively. For the three months ended March
31, 1997, cash was used to purchase short-term investments, acquire capital
equipment and to obtain and establish patents. During the same period of 1996,
cash was used primarily to acquire capital equipment.
Cash provided by financing activities was $23,000 and $437,000 for the three
months ended March 31, 1997 and 1996, respectively. The Company's financing
activities during the three months ended March 31, 1997 were sales of Common
Stock resulting from employee stock option exercises. During the three months
ended March 31, 1996, the Company's only financing activities were borrowings
from Sharpoint.
9
Item 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
In January 1997, the Company entered into a five-year capital lease covering
laboratory and scientific equipment and computers. Monthly rent obligation under
the lease is equal to 2.19 percent of the total equipment cost outstanding up to
$1,500,000. As of March 31, 1997, the Company had not borrowed under this
capital lease.
The Company believes that existing cash and cash equivalents, including the
proceeds from the initial public offering and its follow-on offering in April
1997 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, (v) the effect of
competing technological and market developments and (vi) general economic
conditions. 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. Other than the Company's
equipment financing lines of credit, 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, if at all.
10
PART II. OTHER INFORMATION
Item 6. Exhibits and Reports on Form 8-K
(a) Exhibits.
11 Computation of pro forma net income (loss) per share (see Note
4 to Notes to Financial Statements in Item 1 of this Form
10-Q).
27 Financial Data Schedule.
(b) Reports on Form 8-K.
Form 8-K dated January 13, 1997 relating to the change of the
Company's name to Closure Medical Corporation (effective as of
January 13, 1997) from Tri-Point Medical Corporation, as well as the
change in the Company's trading symbol for the Common Stock on the
Nasdaq National Market to "CLSR" (effective as of January 13, 1997)
from "TPMC."
11
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.
CLOSURE MEDICAL CORPORATION
Date: May 14, 1997 By: /s/Robert V. Toni
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Robert V. Toni
President and Chief Executive Officer
Date: May 14, 1997 By: /s/J. Blount Swain
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J. Blount Swain
Vice President and Chief Financial Officer
(Principal Financial and Accounting Officer)