<PAGE> 1
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 September 30, 1998
------------------
Commission file number 000-20699
---------
COLLABORATIVE CLINICAL RESEARCH, INC.
- --------------------------------------------------------------------------------
(Exact name of registrant as specified in its charter)
Ohio 34-1685364
- ---------------------------------------- ----------------------------
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
20600 Chagrin Boulevard
Cleveland, Ohio 44122
- ---------------------------------------- ----------------------------
(Address of principal executive offices) (Zip Code)
(216) 491-9930
- --------------------------------------------------------------------------------
(Registrants telephone number, including area code)
N/A
- --------------------------------------------------------------------------------
(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. X Yes No
--- ---
Indicate the number of shares outstanding of each of the issuers classes of
common stock, as of the latest practical date.
The number of Common Shares, without par value, outstanding as of October 31,
1998 was 6,422,872.
<PAGE> 2
PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
COLLABORATIVE CLINICAL RESEARCH, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
<TABLE>
<CAPTION>
(Note A) (Unaudited)
December 31, September 30,
1997 1998
------------ -------------
<S> <C> <C>
ASSETS
Current assets:
Cash and cash equivalents $ 6,381,512 $ 3,331,224
Short-term investments 27,231,976 24,627,527
Accounts receivable, less allowances 4,497,255 2,177,007
Prepaid expenses and other current assets 880,500 248,495
------------ ------------
Total current assets 38,991,243 30,384,253
Property and equipment, at cost
net of accumulated depreciation and amortization 1,560,851 2,640,343
Goodwill, less accumulated amortization 7,727,014 1,354,467
Other assets 41,530 25,984
============ ============
Total assets $ 48,320,638 $ 34,405,047
============ ============
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 779,542 $ 876,769
Accrued expenses 4,338,686 3,872,820
Deferred revenue 852,132 846,850
------------ ------------
Total current liabilities 5,970,360 5,596,439
Shareholders' equity:
Foreign currency translation ---- (7,976)
Serial preferred shares, without par value,
authorized 1,000,000 shares; none issued ---- ----
Common shares, without par value, authorized
15,000,000 shares; issued and outstanding
6,412,872 shares as of December 31, 1997
and 6,422,872 as of September 30, 1998 49,697,057 49,704,742
Retained earnings (accumulated deficit) (7,346,779) (20,888,158)
------------ ------------
Total shareholders' equity 42,350,278 28,808,608
============ ============
Total liabilities and shareholders' equity $ 48,320,638 $ 34,405,047
============ ============
</TABLE>
Note A: The balance sheet at December 31, 1997 has been derived from the
audited consolidated financial statements at that date, but does not
include all of the information and footnotes required by generally
accepted accounting principles for complete financial statements.
See notes to condensed consolidated financial statements.
2
<PAGE> 3
COLLABORATIVE CLINICAL RESEARCH, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
<TABLE>
<CAPTION>
Three Months Ended Nine Months Ended
September 30, September 30,
----------------------------- -----------------------------
1997 1998 1997 1998
------------ ------------ ------------ -------------
<S> <C> <C> <C> <C>
Revenue $ 3,647,445 $ 3,689,719 $12,684,598 $ 8,707,550
Direct costs 2,809,942 3,002,101 9,199,230 7,381,022
----------- ----------- ----------- ------------
Gross profit 837,503 687,618 3,485,368 1,326,528
Selling, general and administrative expenses 2,500,303 2,118,220 6,555,579 7,155,757
Special items ----- 6,343,019 ----- 8,054,206
Depreciation and amortization 294,871 339,007 763,276 895,813
----------- ----------- ----------- ------------
Loss from operations (1,957,671) (8,112,628) (3,833,487) (14,779,248)
Other income (expense):
Interest income 480,954 405,485 1,470,890 1,317,869
Loss from joint venture ----- ----- (47,788) -----
----------- ----------- ------------
Loss before income taxes (1,476,717) (7,707,143) (2,410,385) (13,461,379)
Income tax expense (benefit) (14,392) ----- (43,178) 80,000
----------- ----------- ----------- ------------
Net loss $(1,462,325) $(7,707,143) $(2,367,207) $(13,541,379)
=========== =========== =========== ============
Net loss per share $ (0.23) $ (1.20) $ (0.37) $ (2.11)
=========== =========== =========== ============
Weighted average common shares outstanding 6,402,343 6,422,872 6,376,568 6,421,465
=========== =========== =========== ============
</TABLE>
See notes to condensed consolidated financial statements.
3
<PAGE> 4
COLLABORATIVE CLINICAL RESEARCH, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
<TABLE>
<CAPTION>
Nine Months Ended September 30,
-------------------------------------
1997 1998
---------------- ----------------
<S> <C> <C>
OPERATING ACTIVITIES
Net loss $ (2,367,207) $ (13,541,379)
Adjustments to reconcile net loss to net cash
used in operating activities:
Depreciation and amortization 763,276 895,813
Special items ----- 8,054,206
Other (726,677) (1,059,182)
Changes in operating assets and liabilities:
Accounts receivable 1,877,548 2,249,598
Accounts payable and accrued expenses (466,283) (2,311,960)
Other (723,243) 469,467
------------- -------------
Net cash used in operating activities (1,642,586) (5,243,437)
INVESTING ACTIVITIES
Purchases of property and equipment (1,326,790) (1,646,246)
Purchase of businesses (net of cash acquired) (7,868) -----
Maturities of short term investments 46,309,484 53,777,886
Purchases of short term investments (43,548,411) (50,030,054)
Investment in HRI (33,660) 7,802
------------- -------------
Net cash provided by investing activities 1,392,755 2,109,388
FINANCING ACTIVITIES
(Issuance) repayment of notes receivable-officer (165,000) 165,000
Net proceeds from issuance of common shares 169,150 2,100
------------- -------------
Net cash provided by financing activities 4,150 167,100
Effect of exchange rate on cash ----- (83,339)
------------- -------------
Decrease in cash and cash equivalents (245,681) (3,050,288)
Cash and cash equivalents at beginning of period 5,509,460 6,381,512
------------- -------------
CASH AND CASH EQUIVALENTS AT END OF PERIOD $ 5,263,779 $ 3,331,224
============= =============
</TABLE>
See notes to condensed consolidated financial statements.
4
<PAGE> 5
COLLABORATIVE CLINICAL RESEARCH, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September 30, 1998
(Unaudited)
1. BASIS OF PRESENTATION
The accompanying unaudited condensed consolidated 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. Operating results for the three and nine month periods ended
September 30, 1998 are not necessarily indicative of the results that may be
expected for the year ended December 31, 1998. For further information, refer to
the consolidated financial statements and footnotes thereto included in the
Company's Form 10-K for the year ended December 31, 1997 (File No. 000-20699).
The preparation of financial statements in conformity with generally accepted
accounting principles requires management to make estimates and assumptions that
might affect the amounts reported in the financial statements and accompanying
notes. Actual results could differ from those estimates.
2. FOREIGN CURRENCY TRANSLATION
The assets and liabilities of the Company's foreign subsidiaries are translated
into U.S. dollars at current exchange rates. Revenue and expense accounts of
these operations are translated at average rates prevailing during the period.
These translation adjustments are accumulated in a separate component of
shareholders' equity. Foreign currency transaction gains and losses are included
in determining net income (loss) for the period in which the exchange rate
changes.
3. NET LOSS PER SHARE
The following table sets forth the computation of basic and diluted earnings per
share.
<TABLE>
<CAPTION>
Three Months Ended September 30, Nine Months Ended September 30,
--------------------------------- ------------------------------
1997 1998 (A) 1997 1998 (A)
<S> <C> <C> <C> <C>
Net loss used in the calculation of basic and
diluted loss per share $ (1,462,325) $ (7,707,143) $ (2,367,207) $ (13,541,379)
============ ============ ============ =============
Denominator for basic net loss per share -
weighted average Common Shares 6,402,343 6,422,872 6,376,568 6,421,465
outstanding
Effect of dilutive Common Share options and
warrants --- --- --- ---
------------ ------------ ------------ -------------
Denominator for diluted net loss per share 6,402,343 6,422,872 6,376,568 6,421,465
============ ============ ============ =============
Basic net loss per share $ (0.23) $ (1.20) $ (0.37) $ (2.11)
============ ============ ============ =============
Diluted net loss per share $ (0.23) $ (1.20) $ (0.37) $ (2.11)
============ ============ ============ =============
</TABLE>
(A) Includes special items charges of $6,343,019 and $8,054,206, or $0.99 and
$1.25 per share, for the three and nine months ended September 30, 1998,
respectively.
Common Share options were excluded from the computation of diluted earnings per
share due to the Company's net loss. Inclusion of these options in the
computation of diluted earnings per share would have an antidilutive effect on
net loss per share.
5
<PAGE> 6
COLLABORATIVE CLINICAL RESEARCH, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS - CONTINUED
September 30, 1998
(Unaudited)
4. IMPAIRMENT OF LONG-LIVED ASSETS
During 1996, the Company adopted Statement of Financial Accounting Standards No.
121, "Accounting for the Impairment of Long-Lived Assets and for Long-Lived
Assets to be Disposed Of" ("SFAS No. 121"). This requires impairment losses to
be recorded on long-lived assets used in operations when indicators of
impairment are present and the undiscounted cash flows estimated to be generated
by those assets are less than the assets' carrying amounts. As a result of the
Company's review process, $6,056,019 (or $0.94 per share) of goodwil was
written down during the three-month period ended September 30, 1998.
5. SPECIAL ITEMS
In March 1998, the Company announced a reorganization plan including a reduction
of 29 employees. In connection with this plan, the Company recorded a charge of
$1,439,762 in the first quarter of 1998 to recognize costs associated with
employee severance and other special items. In June 1998, an additional special
items charge of $271,425 was recorded related to the closing of the Company's
United Kingdom operations (including the termination of two employees), the
termination of a joint venture in the United Kingdom and other activities.
In September 1998, a special items charge of $6,343,019 was recorded. This
charge included the $6,056,019 related to the impairment of goodwill, and
$287,000 of other costs associated with the closure of two of the Company's
clinical sites, which were acquired in October 1996, and severance related
costs for two employees at these locations.
Details of the special items, of which asset impairments represent non-cash
charges, are as follows:
<TABLE>
<CAPTION>
ASSET TERMINATION OTHER EXIT
IMPAIRMENTS BENEFITS COSTS
-------------------------------------------
<S> <C> <C> <C>
Provision in fourth quarter of 1997 $ 894,597 $ --- $2,100,000
------------ ----------
Reserve at December 31, 1997 --- 2,100,000
Charges in 1998 6,154,042 1,227,762 672,402
Payments in 1998 567,062 2,319,506
------------ ----------
Reserve at September 30, 1998 $ 660,700 $ 452,896
============ ==========
</TABLE>
6. SEGMENT DISCLOSURES AND RELATED INFORMATION
In June 1997, the Financial Accounting Standards Board issued Statement No. 131,
"Disclosures about Segments of an Enterprise and Related Information" ("SFAS No.
131"), which is effective for years beginning after December 15, 1997. SFAS 131
establishes standards for the way that public business enterprises report
information about operating segments in annual financial statements and requires
that those enterprises report selected information about operating segments in
interim financial reports. It also establishes standards for related disclosures
about products and services, geographic areas and major customers. Management
has not completed its review of SFAS 131, but anticipates reporting information
for two segments (Clinical division and DataTRAK, Inc.) for the year ended
December 31, 1998.
7. RECLASSIFICATION
Certain prior year amounts have been reclassified to conform to the current year
reporting presentation.
6
<PAGE> 7
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF RESULTS OF OPERATIONS AND
FINANCIAL CONDITION
GENERAL
Collaborative Clinical Research, Inc. ("Collaborative" or the "Company") is a
multi-specialty Site Management Organization ("SMO"). Collaborative's customers
("Sponsors") are primarily pharmaceutical and biotechnology companies and, to a
lesser extent, contract research organizations ("CRO's"). The Company's Clinical
division provides services to three segments of the pharmaceutical and
biotechnology industries. Through WCE Clinical Evaluations ("WCE"), it provides
prescription drug to over the counter ("OTC") switch and other OTC services. In
addition, the Clinical division provides phase I research service from its
80-bed clinic at GFI Pharmaceutical Services, Inc ("GFI"). Finally, through the
division's six therapeutically focused sub-networks, which are drawn from over
450 affiliated research sites ("Affiliated Sites"), phase II, III, and IV
research is performed. DataTRAK, Inc., Collaborative's wholly owned electronic
data capture subsidiary, provides technology and other services to assist
Sponsors in accelerating the completion of clinical trials.
Through the Clinical division, the Company enters into contracts that provide a
fixed price for each component or service delivered. The ultimate contract value
depends on such variables as the number of research sites selected, patients
enrolled and other services required by the Sponsor. Generally, these contracts
range in duration from several months to several years. As services are
performed over the life of the contract, revenue is earned under the percentage
of completion method utilizing units of delivery. Costs associated with contract
revenue are recognized as incurred. Pass-through costs that are paid directly by
the Company's Sponsors, and for which the Company does not bear the risk of
economic loss, are excluded from revenue. These clinical trial costs can include
investigator meeting fees, IRB fees and travel costs. The termination of a
contract results in no material adjustments to revenue or direct costs
previously recognized, and the Company is entitled to payment for all work
performed through the date of notice of termination and all costs associated
with termination of a study.
The Company's backlog at October 22, 1998 was $17.2 million, as compared to
backlog of $25.9 million at December 31, 1997. The current backlog reflects the
addition of $17.0 million of new backlog during 1998. The amount of backlog is
not necessarily indicative of the Company's future quarterly or annual revenues.
The Company has taken several steps to reorganize its sales and operating
structure and expects to show continued operating improvement in the fourth
quarter of 1998, however, it does not expect to reach a breakeven.
RESULTS OF OPERATIONS
Three months ended September 30, 1998 compared with three months ended
September 30, 1997
Revenue for the three months ended September 30, 1998 increased 2.8% to $3.7
million as compared to $3.6 million in the three-month period ended September
30, 1997. The increase was the result of a slight rise in revenue from clinical
trials conducted within the Company's Clinical division and the revenue
generated by the DataTRAK division during the three months ended September 30,
1998. Management has taken actions that it believes will result in growth in the
Company's level of backlog and the conversion of backlog into revenue during the
remainder of 1998. The Company's DataTRAK division, which began operations in
the second half of 1997, contributed $33,000 of revenue for the three months
ended September 30,1998.
Direct costs include compensation and related fringe benefits for
non-administrative employees (including employees at company-owned research
facilities) and other expenses directly related to contracts, which can be
subcontracted to the Affiliated Sites and other vendors. These costs increased
by $200,000, or 7.1%, from $2.8 million to $3.0 million for the three months
ended September 30, 1997 and 1998, respectively. As a percentage of revenue,
direct costs increased from 77.8% during the three months ended September 30,
1997 to 81.1% during the three months ended September 30, 1998. The reduction in
gross profit
7
<PAGE> 8
percentage was the result of additional direct costs for DataTRAK and the
Clinical division's inability to leverage fixed costs at its company-owned
research facilities.
Selling, general and administrative ("SG&A") expenses include all administrative
personnel costs, business and Affiliated Site development costs, and all other
expenses not directly chargeable to a specific contract. These costs for the
three-month period ended September 30, 1998 decreased 16.0% to $2.1 million as
compared to $2.5 million during the three months ended September 30, 1997. The
decrease consists of a reduction of approximately $500,000 of the Company's
Clinical division expenses and corporate overhead costs, resulting from the
reorganization of the Company during 1998. This decrease was offset by a
$100,000 increase in SG&A expenses incurred for the development of DataTRAK. As
a percentage of revenue, selling, general and administrative expenses decreased
from 69.4% to 56.8% for the three months ended September 30, 1997 and 1998,
respectively. Part of the decrease in selling, general and administrative
expenses as a percentage of revenue was the result of the Company's slight
increase in revenue.
Special items for the three months ended September 30, 1998 were $6.3 million.
The write down associated with the impairment of goodwill at the Company's
wholly owned subsidiaries accounted for $6.1 million of this expense. The
remainder of these costs resulted from the closing of two of the Company's owned
clinical research locations.
Depreciation and amortization expense increased from $295,000 in the three month
period ended September 30, 1997 to $339,000 during the three months ended
September 30, 1998. The increase was a result of the Company's increased capital
expenditures, primarily incurred by its DataTRAK division, including the cost to
acquire the software now known as DataTRAK EDC(TM).
Other income decreased $76,000 from $481,000 in the three month period ended
September 30, 1997 to $405,000 in the three month period ended September 30,
1998. This was primarily the result of a decrease in interest income caused by
the Company's use of cash to fund its operating losses and other working capital
needs.
Nine months ended September 30, 1998 compared with nine months ended
September 30, 1997
Revenue for the nine months ended September 30, 1998 decreased 31.5% to $8.7
million as compared to $12.7 million in the nine-month period ended September
30, 1997. The decrease was the result of a decline in revenue from clinical
trials conducted within the Company's Clinical division, caused by the Clinical
division's inability to attract sufficient new business and convert existing
backlog into revenue during the nine months ended September 30, 1998. The
Company's DataTRAK division, which began operations in the second half of 1997,
contributed $111,000 of revenue for the nine months ended September 30, 1998.
Direct costs decreased by $1.8 million, or 19.6%, from $9.2 million to $7.4
million for the nine months ended September 30, 1997 and 1998, respectively. As
a percentage of revenue, direct costs increased from 72.4% during the nine
months ended September 30, 1997 to 85.1% during the nine months ended
September 30, 1998. The reduction in gross profit percentage was the result of
the Company's low level of revenue and its inability to leverage its fixed costs
at its company-owned research facilities.
Selling, general and administrative costs for the nine-month period ended
September 30, 1998 increased 9.1% to $7.2 million as compared to $6.6 million
during the nine months ended September 30, 1997. The increase consisted of $1.0
million incurred for the development of the DataTRAK division, which was offset
by a $100,000 decrease in the SG&A expenses incurred by the Clinical division as
a result of the reorganization of that division's sales and operating structure.
The increase was also offset by the absence of $300,000 of expenses that were
incurred during the nine months ended September 30, 1997, as a result of the
Company's terminated negotiations to acquire U-Gene Research BV. As a percentage
of revenue, selling, general and administrative expenses increased from 52.0% to
82.8% for the nine months ended September 30, 1997 and 1998, respectively. Part
of the increase in selling, general and administrative
8
<PAGE> 9
expenses as a percentage of revenue was the result of the Company's low level of
revenue being unable to absorb its fixed operating costs.
Special items for the nine months ended September 30, 1998 were $8.0 million. Of
this total, $1.4 million was incurred as part of the Company's reorganization
plan, announced during the first quarter of 1998, and include costs for employee
severance and other special items. An additional $6.1 million resulted from the
write down of impaired goodwill. The remaining $500,000 was incurred as a result
of the Company exiting its United Kingdom activities, and the closing of two of
its owned clinical sites.
Depreciation and amortization expense increased from $763,000 in the nine month
period ended September 30, 1997 to $896,000 during the nine months ended
September 30, 1998. The increase was a result of the Company's increased capital
expenditures, including the cost to acquire the software now known as DataTRAK
EDC(TM).
Other income decreased $100,000 for the nine month period ended September 30,
1998 compared to the nine months ended September 30, 1997. The decrease was
primarily the result of a decrease in interest income caused by the Company's
use of cash to fund its operating losses and other working capital needs. This
decrease was partially offset by the termination of the Company's HRI joint
venture during 1997. During the nine month period ended September 30, 1997, the
Company's share of the loss from this joint venture was $48,000.
LIQUIDITY AND CAPITAL RESOURCES
The Company's contracts usually require a portion of the contract amount to be
paid at the time the contract is initiated. Additional payments are generally
made upon completion of negotiated performance requirements throughout the life
of the contract. Cash receipts do not necessarily correspond to costs incurred
and revenue recognized (revenue recognition is based on the units of delivery
method of percentage of completion accounting). The Company typically receives a
low volume of large-dollar receipts. Accounts receivable will fluctuate due to
the timing and size of cash receipts. Accounts receivable (net of allowance for
doubtful accounts) was $2.2 million at September 30, 1998 and $4.5 million at
December 31, 1997. Deferred revenue was $850,000 at both September 30, 1998 and
December 31, 1997.
Cash and cash equivalents decreased by $3.1 million during the nine months ended
September 30, 1998. This was the result of $5.3 million being used for operating
activities, offset by $2.2 million being provided by investing and financing
activities. Cash used for operating activities resulted from the funding of net
operating losses and other working capital needs, which were partially offset by
accounts receivable collections. Cash used for investing activities resulted
from $1.7 million being used for capital expenditures, primarily software and
its associated development for DataTRAK, offset by $3.8 million provided by net
maturities of short-term investments. Cash provided by financing activities was
due to the collection of a note receivable from an officer of the Company.
In January 1998, the Company announced the termination of its technology
alliance agreement with ISSC, a unit of IBM Global Services. The alliance was
formed in June 1996 to develop and market an electronic data collection and
project management system for use in clinical trials. The Company and IBM Global
Services disagreed on a number of issues concerning the parties' financial
responsibilities in connection with the termination of the alliance, and in 1997
the Company recorded a provision for its best estimate of its financial
obligations associated with the resolution of these disagreements. In June 1998,
Collaborative and IBM Global Services resolved these issues, and the provision
was adjusted accordingly.
In January 1998, DataTRAK purchased the EDC software known as OpusTWO from EDS
Germany. The Company will be responsible for funding the market introduction and
future development and testing of this software, which has been renamed DataTRAK
EDC(TM).
9
<PAGE> 10
The Company anticipates that its capital expenditures for the remainder of 1998
will be approximately $100,000 for its DataTRAK subsidiary and Clinical
division. The Company's principal cash needs on both a short-term and long-term
basis are for the funding of its operations and capital expenditure
requirements. The Company will continue its efforts to expand its operations
through internal growth, joint ventures and alliances, and upon successful
completion of its turn-around, through strategic acquisitions. The Company
expects such activities will be funded from existing cash and cash equivalents,
maturities of short-term investments, cash flow from operations and borrowings
under its line of credit.
The Company has a line of credit agreement with a bank, which provides for
borrowings up to $2.0 million and bears interest at rates not to exceed prime
(no amounts are outstanding at September 30, 1998). The line of credit agreement
requires that the Company maintain investments of $2.0 million with the bank.
This line of credit is considered to be committed and is subject to renewal at
January 31, 2000.
The Company is currently assessing all of its computer systems and related
equipment, which may rely on computer technologies to ensure that they are Year
2000 compliant. As a result of this assessment, The Company does not believe it
has any Year 2000 issues that will affect it directly. The Company does not
anticipate incurring any material operating expenses or significant computer
system investments to be Year 2000 compliant. However, Year 2000 issues incurred
by the Company's Affiliated Sites, Sponsors or other vendors and customers could
indirectly affect the Company.
The Company believes that cash generated from operations, maturities of
short-term investments and amounts available under its line of credit will be
sufficient to fund its working capital and capital expenditure requirements for
the foreseeable future. However, selective acquisitions and joint ventures may
play a role in the Company's growth strategy. To the extent that the Company
were to acquire additional research organizations, it may require additional
capital. There can be no assurance as to the Company's ability to obtain
additional financing.
INFORMATION ABOUT FORWARD-LOOKING STATEMENTS
Certain statements made in this Form 10-Q, other SEC filings or written
materials or orally by the Company or its representatives may constitute
forward-looking statements. These forward-looking statements are subject to the
safe harbor provided by the Securities Litigation Reform Act of 1995. Without
limitation, factors that may cause actual results to differ from these
forward-looking statements include the Company's success in attracting new
business, the size and duration of clinical trials in which the Company and
members of its network of Affiliated Sites participate, the timing of payments
from Sponsors, the timing of Sponsor decisions to conduct new clinical trials or
cancel or delay ongoing trials, and other factors many of which are beyond the
Company's control. The Company's success also depends on the various strategic
initiatives that it has undertaken, all of which are based on assumptions made
by the Company concerning trends in the clinical research market and the health
care industry. In addition, actual results and performance could differ
materially from those expressed or implied in these forward-looking statements
as a result of a number of known and unknown risks which are discussed in the
Company's Annual Report on Form 10-K for the year ended December 31, 1997.
10
<PAGE> 11
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
None.
Item 2. Changes in Securities and Use of Proceeds
None.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Submission of Matters to a Vote of Security Holders
None.
Item 5. Other Information
None.
Item 6. Exhibits and Reports on Form 8-K
(a) Exhibits
See the Exhibit Index at page E-1 of this Form 10-Q.
(b) Reports on Form 8-K
No reports were filed on form 8-K during the three months ended
September 30, 1998.
11
<PAGE> 12
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.
Collaborative Clinical Research, Inc.
----------------------------------------------------
Registrant
Date: 11/13/98 /s/ Jeffrey A. Green
---------------- ----------------------------------------------------
Jeffrey A. Green,
President and Chief Executive Officer and a Director
(Principal Executive Officer)
Date: 11/13/98 /s/ Terry C. Black
---------------- ----------------------------------------------------
Terry C. Black,
Vice President of Finance, Chief Financial Officer,
Treasurer and Assistant Secretary
(Principal Financial Officer)
12
<PAGE> 13
EXHIBIT INDEX
<TABLE>
<CAPTION>
EXHIBIT NO. DESCRIPTION PAGE
- ----------- ----------- ----
<S> <C> <C>
3.1 Fifth Amended and Restated Articles of Incorporation (B)
3.2 Third Amended and Restated Code of Regulations (B)
4.1 Specimen Certificate of the Company's Common Shares,
without par value (A)
4.2 Credit Agreement between the Company and Key Bank,
dated October 1, 1997 (C)
4.3 Second Amended and Restated Registration Agreement,
dated July 15,1994, as amended on June 1, 1995 and
February 5, 1996 (A)
15.1 Independent Accountants' Review Report
27.1 Financial Data Schedule
</TABLE>
- --------------------------------------------------------------------------------
(A) Incorporated herein by reference to the appropriate exhibit to the Company's
Registration Statement on Form S-1 (Registration statement No. 333-2140).
(B) Incorporated herein by reference to the appropriate exhibit to the Company's
Form 10-Q for the quarterly period ended June 30, 1996 (Commission file No.
000-20699).
(C) Incorporated herein by reference to the appropriate exhibit to the Company's
Form 10-K for the year ended December 31, 1997 (Commission file
No. 000-20699).
E-1
<PAGE> 1
EXHIBIT 15.1
INDEPENDENT ACCOUNTANTS' REVIEW REPORT
The Board of Directors and Shareholders
Collaborative Clinical Research, Inc.
We have reviewed the accompanying condensed consolidated balance sheet of
Collaborative Clinical Research, Inc. and subsidiaries (the "Company") as of
September 30, 1998, and the related condensed consolidated statements of
operations for the three-month and nine-month periods ended September 30, 1997
and 1998, and the condensed consolidated statements of cash flows for the
nine-month periods ended September 30, 1997 and 1998. These financial statements
are the responsibility of the Company's management.
We conducted our reviews in accordance with standards established by the
American Institute of Certified Public Accountants. A review of interim
financial information consists principally of applying analytical review
procedures to financial data, and making inquiries of persons responsible for
financial and accounting matters. It is substantially less in scope than an
audit conducted in accordance with generally accepted auditing standards, which
will be performed for the full year with the objective of expressing an opinion
regarding the financial statements taken as a whole. Accordingly, we do not
express such an opinion.
Based on our reviews, we are not aware of any material modifications that should
be made to the accompanying condensed consolidated financial statements referred
to above for them to be in conformity with generally accepted accounting
principles.
We have previously audited, in accordance with generally accepted auditing
standards, the consolidated balance sheet of Collaborative Clinical Research,
Inc. and subsidiaries as of December 31, 1997, and the related consolidated
statements of operations, shareholders' equity and cash flows for the year then
ended, not presented herein, and in our report dated January 30, 1998, we
expressed an unqualified opinion on those consolidated financial statements. In
our opinion, the information set forth in the accompanying condensed
consolidated balance sheet as of December 31, 1997 is fairly stated, in all
material respects, in relation to the consolidated balance sheet from which it
has been derived.
Cleveland, Ohio ERNST & YOUNG LLP
October 19, 1998
<TABLE> <S> <C>
<ARTICLE> 5
<LEGEND>
THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM SEPTEMBER
30, 1998 CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) AND IS
QUALIFIED IN ITS ENTIRETY BY REFERENCE TO SUCH FINANCIAL STATEMENTS.
</LEGEND>
<MULTIPLIER> 1
<S> <C>
<PERIOD-TYPE> 9-MOS
<FISCAL-YEAR-END> DEC-31-1998
<PERIOD-START> JAN-01-1998
<PERIOD-END> SEP-30-1998
<CASH> 27,958,751
<SECURITIES> 0
<RECEIVABLES> 2,557,614
<ALLOWANCES> 380,607
<INVENTORY> 0
<CURRENT-ASSETS> 30,384,253
<PP&E> 3,980,830
<DEPRECIATION> 1,340,487
<TOTAL-ASSETS> 34,405,047
<CURRENT-LIABILITIES> 5,596,439
<BONDS> 0
0
0
<COMMON> 49,704,742
<OTHER-SE> (20,888,158)
<TOTAL-LIABILITY-AND-EQUITY> 34,405,047
<SALES> 0
<TOTAL-REVENUES> 8,707,550
<CGS> 0
<TOTAL-COSTS> 7,381,022
<OTHER-EXPENSES> 16,035,126
<LOSS-PROVISION> 70,650
<INTEREST-EXPENSE> 0
<INCOME-PRETAX> (13,461,379)
<INCOME-TAX> 80,000
<INCOME-CONTINUING> (13,541,379)
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> (13,541,379)
<EPS-PRIMARY> (2.109)
<EPS-DILUTED> (2.109)
</TABLE>
