<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 March 31, 1999
--------------
Commission file number 000-20699
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DataTRAK INTERNATIONAL, INC.
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(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
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(Address of principal executive offices) (Zip Code)
(216) 921-6505
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(Registrants telephone number, including area code)
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(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 April 30, 1999
was 6,465,872.
<PAGE> 2
PART I. FINANCIAL INFORMATION
ITEM 1 - FINANCIAL STATEMENTS
DataTRAK INTERNATIONAL, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATION BALANCE SHEETS
<TABLE>
<CAPTION>
(Note A) (Unaudited)
December 31, March 31,
1998 1999
-------------- ---------------
<S> <C> <C>
ASSETS
Current assets:
Cash and cash equivalents $ 4,072,586 $ 3,201,649
Short-term investments 22,620,667 20,583,713
Accounts receivable, less allowances 2,731,567 4,230,879
Prepaid expenses and other current assets 366,352 212,176
------------ ------------
Total current assets 29,791,172 28,228,417
Property and equipment, at cost
net of accumulated depreciation and amortization 2,393,266 2,249,339
Goodwill, less accumulated amortization 1,335,193 1,315,919
Other assets 20,168 20,168
------------ ------------
Total assets $ 33,539,799 $ 31,813,843
============ ============
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 1,012,454 $ 1,055,730
Accrued expenses 3,664,577 3,216,717
Deferred revenue 625,068 386,454
------------ ------------
Total current liabilities 5,302,099 4,658,901
Shareholders' equity:
Foreign currency translation (44,041) (18,995)
Serial preferred shares, without par value, 1,000,000 shares
authorized, none issued ----- -----
Common shares, without par value, authorized 15,000,000
shares; issued and outstanding 6,422,872 shares as of
December 31, 1998 and 6,430,872 as of March 31,1999 49,704,742 49,705,942
Retained earnings (accumulated deficit) (21,423,001) (22,532,005)
------------ ------------
Total shareholders' equity 28,237,700 27,154,942
------------ ------------
Total liabilities and shareholders' equity $ 33,539,799 $ 31,813,843
============ ============
</TABLE>
Note A: The balance sheet at December 31, 1998 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
DataTRAK INTERNATIONAL, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATION STATEMENTS OF OPERATIONS
(UNAUDITED)
<TABLE>
<CAPTION>
Three Months Ended
March 31,
-------------------------------
1998 1999
----------- -----------
<S> <C> <C>
Revenue $ 2,364,283 $ 4,179,648
Direct costs 2,025,077 2,649,177
----------- -----------
Gross profit 339,206 1,530,471
Selling, general and administrative expenses 2,657,311 2,517,527
Special items 1,439,762 -----
Depreciation and amortization 270,590 249,314
----------- -----------
Loss from operations (4,028,457) (1,236,370)
Other income (expense):
Interest income 465,132 322,753
Other expense ----- (155,387)
----------- -----------
Loss before income taxes (3,563,325) (1,069,004)
Income tax expense 55,000 40,000
----------- -----------
Net loss $(3,618,325) $(1,109,004)
=========== ===========
Basic and diluted net loss per share $ (0.56) $ (0.17)
=========== ===========
Weighted average common shares outstanding 6,418,794 6,428,028
=========== ===========
</TABLE>
See notes to condensed consolidated financial statements.
3
<PAGE> 4
DataTRAK INTERNATIONAL, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATION STATEMENTS OF CASH FLOWS
(UNAUDITED)
<TABLE>
<CAPTION>
Three Months Ended March 31,
-------------------------------------
1998 1999
---------------- ----------------
<S> <C> <C>
OPERATING ACTIVITIES
Net income (loss) $ (3,618,325) $ (1,109,004)
Adjustments to reconcile net income (loss) to net cash
provided by (used in) operating activities:
Depreciation and amortization 270,590 249,314
Other (368,119) (111,766)
Changes in operating assets and liabilities:
Accounts receivable 2,835,364 (1,518,801)
Accounts payable and accrued expenses 673,829 (557,090)
Other 173,776 (81,442)
---------------- ----------------
Net cash provided by (used in) operating activities (32,885) (3,128,789)
INVESTING ACTIVITIES
Purchases of property and equipment (884,949) (150,793)
Maturities of short term investments 15,970,008 18,289,128
Purchases of short term investments (15,885,321) (15,967,021)
Investment in HRI 6,800 -----
---------------- ----------------
Net cash provided by (used in) investing activities (793,462) 2,171,314
FINANCING ACTIVITIES
Repayment of note receivable-officer 165,000 -----
Net proceeds from issuance of common shares 1,950 1,200
---------------- ----------------
Net cash provided by (used in) financing activities 166,950 1,200
Effect of exchange rate on cash 858 85,338
---------------- ----------------
Increase (decrease) in cash and cash equivalents (658,539) (870,937)
Cash and cash equivalents at beginning of period 6,381,512 4,072,586
---------------- ----------------
CASH AND CASH EQUIVALENTS AT END OF PERIOD $ 5,722,973 $ 3,201,649
================ ================
</TABLE>
See notes to condensed consolidated financial statements.
4
<PAGE> 5
DataTRAK INTERNATIONAL, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 1999
(UNAUDITED)
1. BASIS OF PRESENTATION
The accompanying unaudited condensed consolidated financial statements of
DataTRAK International Inc. (formerly collaborative Clinical Research,
Inc.) and subsidiaries (the "Company") 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 month period ended
March 31, 1999 are not necessarily indicative of the results that may be
expected for the year ended December 31, 1999. 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, 1998
(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. NET LOSS PER SHARE
The following table sets forth the computation of basic and diluted loss per
share.
<TABLE>
<CAPTION>
THREE MONTHS ENDED MARCH 31,
-------------------------------
1998 1999
---- ----
<S> <C> <C>
Net loss used in the calculation of basic and
diluted earnings per share $(3,618,325) $(1,109,004)
=========== ===========
Denominator for basic net loss per share -
weighted average Common Shares
outstanding 6,418,794 6,428,028
Effect of dilutive Common Share options and
warrants --- ---
----------- -----------
Denominator for diluted net loss per share 6,418,794 6,428,028
=========== ===========
Basic net loss per share $ (0.56) $ (0.17)
=========== ===========
Diluted net loss per share $ (0.56) $ (0.17)
=========== ===========
Common Share options excluded from the
computation of diluted net loss per share
because they would have an antidilutive
effect on net loss per share 530,850 432,450
=========== ===========
</TABLE>
5
<PAGE> 6
DataTRAK INTERNATIONAL, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 1999
(UNAUDITED)
3. SPECIAL ITEMS
The Company recorded a special items charge of $1,439,762 in the first
quarter of 1998. Included in this charge was $1,194,762 to recognize costs
associated with employee severance related to the March 24, 1998
termination of 29 employees pursuant to a reorganization plan announced in
March 1998. An additional $245,000 was recorded related to other exit
costs. As of March 31, 1999, $790,709 related to employee termination
benefits and $188,012 related to other items had been paid out related to
the first quarter of 1998 special items.
4. SEGMENT DISCLOSURES AND RELATED INFORMATION
The Company operates in two principal business segments: the Clinical Business
and DataTRAK. The Clinical Business provides Phase I through IV clinical
research services and over the counter product services. DataTRAK provides
technology and other services to assist in the timely completion of clinical
trials.
The Company evaluates performance and allocates resources based on profit or
loss from operations before other income and expense and income taxes. The
accounting policies of the reportable segments are the same as those described
in the summary of significant accounting policies. There have been no
intersegment sales.
The Company's reportable segments are business units that offer different
services utilized in the performance of clinical trials. The reportable segments
are managed separately because they offer separate and distinct services to
customers in the clinical research industry.
Information on the Company's business segments is as follows:
<TABLE>
<CAPTION>
CLINICAL OTHER
THREE MONTHS YEAR ENDED MARCH 31, BUSINESS DATATRAK CORPORATE TOTAL
--------------------------------- -------- -------- --------- -----
<S> <C> <C> <C> <C>
Revenue:
1998 $ 2,353,224 $ 11,059 $ --- $ 2,364,283
1999 4,146,039 33,609 --- 4,179,648
Income (loss) from operations:
1998 (2,013,200) (624,789) (1,390,468) (4,028,457)
1999 304,871 (1,009,233) (532,008) (1,236,370)
Assets at December 31, 1998 5,175,149 1,170,105 27,194,545 33,539,799
Assets at March 31, 1999 6,477,141 1,270,345 24,066,357 31,813,843
</TABLE>
6
<PAGE> 7
DataTRAK INTERNATIONAL, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 1999
(UNAUDITED)
5. SALE OF CLINICAL BUSINESS
On December 21, 1998, the Company entered into a definitive agreement, subject
to shareholder approval, to sell its Clinical Business to The West Company,
Incorporated ("West") for $15.0 million, less applicable transaction costs, and
adjustments for working capital and the collection of net accounts receivable.
The sale of the Clinical Business was approved by the Company's shareholders on
April 14, 1999, and the Clinical Business was sold to West on April 20, 1999.
Unaudited pro forma data as though the Company had completed this sale at the
beginning of 1998 are set forth below. The pro forma operating results are not
necessarily indicative of what would have occurred had the transaction taken
place on January 1, 1998.
<TABLE>
<CAPTION>
YEAR ENDED THREE MONTHS ENDED
DECEMBER 31, 1998 MARCH 31, 1999
----------------- --------------
<S> <C> <C>
Pro forma revenue $ 131,752 $ 33,609
Pro forma net loss (3,946,468) (1,268,779)
Pro forma basic loss per share (0.61) (0.20)
Pro forma diluted loss per share (0.61) (0.20)
</TABLE>
7
<PAGE> 8
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF RESULTS OF OPERATIONS AND
FINANCIAL CONDITION
The information set forth and discussed below for the three months ended March
3l, 1999 is derived from the Condensed Consolidated Financial Statements
included elsewhere herein. The financial information set forth and discussed
below is unaudited, but in the opinion of management, reflects all adjustments
(consisting of normal recurring accruals) necessary for a fair presentation of
such information. The Company's results of operations for a particular quarter
may not be indicative of results expected during the other quarters or for the
entire year.
GENERAL
DataTRAK International, Inc. (the "Company") operates two separate businesses
within the clinical research industry. Through its Clinical Business, the
Company operates a multi-specialty site management organization that provides
clinical research services to companies in the clinical pharmaceutical,
biotechnology, contract research organization and medical device research
industries. Through DataTRAK, the Company provides EDC and other services to
assist Sponsors in accelerating the completion of clinical trials.
On December 21, 1998, the Company entered into a definitive agreement, subject
to shareholder approval, to sell its Clinical Business to The West Company,
Incorporated ("West") for $15.0 million, less applicable transaction costs, and
adjustments for working capital and the collection of net accounts receivable.
The sale of the Clinical Business was approved by the Company's shareholders on
April 14, 1999, and the Clinical Business was sold to West on April 20, 1999.
The sale of the Clinical Business has transfered substantially all of the
Company's backlog to West, and the Company will no longer generate revenue from
the operation of the Clinical Business. Consequently, the DataTRAK business is
the sole source of the Company's revenue, and approximately 95% of the Company's
assets, or approximately $39.0 million, are held in cash, cash equivalents and
short-term investments. The Company is currently developing the DataTRAK
business, has recognized minimal revenue to date, and has experienced
significant losses and negative cash flow from operations since the start of
this business in 1997. The Company anticipates that DataTRAK's operating results
will fluctuate significantly from period to period. There can be no assurance of
DataTRAK's long-term future prospects.
The discussion that follows highlights the business conditions and certain
financial information specific to each of the Company's two business segments.
Clinical Business. The Clinical Business provides services to three segments of
the pharmaceutical and biotechnology industries. Through WCE, it provides
clinical research services relating to the reclassification of prescription
drugs into drugs available for over the counter ("OTC") purchase and other OTC
services. In addition, the Clinical Business provides Phase I research services
from its 80-bed clinic at GFI. Finally, through its Affiliated Site Network
which is comprised of six therapeutically focused sub-networks drawn from over
450 affiliated research sites ("Affiliated Sites"), it provides Phase II, III,
and IV research services.
The Company has no ownership interest in any of its Affiliated Sites.
The Clinical Business 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 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
8
<PAGE> 9
entitled to payment for all work performed through the date of notice of
termination and all costs associated with termination of a study.
Contracts in the Clinical Business may generally be terminated by the Sponsor
with or without cause. Some of the reasons clinical trials may be terminated
include unexpected results or adverse patient reactions to the drug, inadequate
patient enrollment or investigator recruitment, manufacturing problems resulting
in shortages of the drug or decisions by the Sponsor to de-emphasize or
terminate a particular trial or development efforts on a particular drug.
Depending on the size of the trial, a Sponsor's decision to terminate or delay
the trial could have a material adverse effect on the Company's backlog, future
revenue and profitability.
The net loss of the Clinical Business was $2.1 million, including a special
items charge of $810,000, for the three months ended March 31, 1998. For the
three months ended March 31, 1999 the Clinical Business had net income of
$160,000.
The Company's backlog at March 31, 1999, substantially all of which related to
the Clinical Business, was $16.0 million, as compared to backlog of $15.8
million at December 31, 1998. The Company believes that its backlog as of any
date is not necessarily a meaningful predictor of future results. There can be
no assurance that the Clinical Business will be able to realize revenue included
in backlog. Delayed contracts remain in the Company's backlog pending
determination of whether to continue, modify or cancel the contract. Concurrent
with the April 20, 1999 sale of the Clinical Business, the Company assigned the
Clinical Business's backlog at that date, estimated to be approximately $15.8
million, to West.
DataTRAK Business. DataTRAK, uses the software known as DataTRAK EDC(TM) to
provide EDC and technology services to Sponsors in order to assist in the more
timely completion of clinical trials. The Company is currently developing this
business, has recognized minimal revenue to date, and has experienced
significant losses and negative cash flow from operations since beginning
operations in 1997. During the three months ended March 31, 1998, DataTRAK had
revenue of $11,000 and a net loss of $620,000, including a special items charge
of $35,000. For the three months ended March 31, 1999, DataTRAK had revenue of
$34,000 and a net loss of $1.0 million. There can be no assurance that the
Company will be successful in achieving commercial acceptance of the DataTRAK(R)
process.
DataTRAK contracts provide a fixed price for each component or service to be
delivered. Services provided by DataTRAK that are in addition to those provided
for in its contracts are billed on a fee for service basis for services
completed. Generally, these contracts range in duration from twelve to eighteen
months. The ultimate contract value is dependent upon the length of the
customers use of DataTRAK EDC(TM) and the services provided by DataTRAK. As
services are performed over the life of the contract, revenue and direct costs
of revenue are recognized under the percentage of completion method utilizing
units of delivery. Costs associated with contract revenues are recognized as
incurred. These contracts can be terminated by the Sponsor with or without
cause. DataTRAK is entitled to payment for all work performed through the date
of notice of termination and for recovery of some or all costs incurred to
terminate a contract. The termination of a contract will not result in a
material adjustment to revenue or costs previously recognized.
DataTRAK is also a seller and licenser of software. Generally, revenue is
recognized upon delivery of sold software. Licensing revenue is recognized
ratably over the life of the license. To date DataTRAK has not recognized any
revenue from software sales.
Since its purchase of the DataTRAK EDC(TM) software, in January 1998, DataTRAK
has recorded revenue related to two fixed unit price clinical trial contracts
and revenue related to Sponsor training on the DataTRAK EDC(TM) software. At
March 31, 1999, DataTRAK's backlog, related to three contracts was $90,000, all
of which the Company expects to convert to revenue during 1999. In the future
DataTRAK may also record revenue related to the sales of software. Due to
DataTRAK's early stage of development and its low level of backlog, there can be
no assurance as to its future levels of revenue.
9
<PAGE> 10
RESULTS OF OPERATIONS
The following tables set forth, for the periods indicated, certain items from
the Company's Consolidated Statements of Operations, expressed in thousands by
line of business.
<TABLE>
<CAPTION>
THREE MONTHS ENDED MARCH 31, 1999
OTHER
CLINICAL DATATRAK CORPORATE
BUSINESS BUSINESS ITEMS TOTAL
---------- ---------- --------- ---------
<S> <C> <C> <C> <C>
Revenue $ 4,146 $ 34 $ ---- $ 4,180
Direct costs 2,498 152 ---- 2,650
------- ------- ------- -------
Gross profit (loss) 1,648 (118) ---- 1,530
Selling, general and
administrative expenses 1,233 776 508 2,517
Depreciation and amortization 110 115 24 249
------- ------- ------- -------
Income (loss) from operations 305 (1,009) (532) (1,236)
Other income (expense) (105) ---- 272 167
------- ------- ------- -------
Income (loss) before income taxes 200 (1,009) (260) (1,069)
Income tax expense 40 ---- ---- 40
------- ------- ------- -------
Net income (loss) $ 160 $(1,009) $ (260) $(1,109)
======= ======= ======= =======
</TABLE>
<TABLE>
<CAPTION>
THREE MONTHS ENDED MARCH 31, 1998
OTHER
CLINICAL DATATRAK CORPORATE
BUSINESS BUSINESS ITEMS TOTAL
---------- ---------- --------- ---------
<S> <C> <C> <C> <C>
Revenue $ 2,353 $ 11 $ ---- $ 2,364
Direct costs 1,929 96 ---- 2,025
------- ------- ------- -------
Gross profit (loss) 424 (85) ---- 339
Selling, general and
administrative expenses 1,437 448 772 2,657
Special items 813 35 592 1,440
Depreciation and amortization 187 57 26 270
------- ------- ------- -------
Loss from operations (2,013) (625) (1,390) (4,028)
Other income (expense) ---- ---- 465 465
------- ------- ------- -------
Loss before income taxes (2,013) (625) (925) (3,563)
Income tax expense (benefit) 55 ---- ---- 55
------- ------- ------- -------
Net loss $(2,068) $ (625) $ (925) $(3,618)
======= ======= ======= =======
</TABLE>
RESULTS OF OPERATIONS
Three months ended March 31, 1999 compared with three months ended
March 31, 1998
Clinical Business. Revenue for the three months ended March 31, 1999 increased
70.8% to $4.1 million as compared to $2.4 million for the three months ended
March 31, 1998. The increase was primarily the result of the growth in revenue
at the Clinical Business's GFI facility. During both three month periods ended
March 31, 1998 and 1999, the Clinical Business performed services on
approximately 100 contracts. The size, duration and difficulty of each contact
varies, therefore the amount of backlog converted into revenue and revenue
earned in any period is independent of the number of contracts on which services
are performed. During 1998, $19.0 million of new contracts was added to backlog,
however, due to the duration of many of these contacts, much of this new backlog
was not converted into revenue in 1998, and there can be no assurance as to the
Clinical Business's level of revenue for the remainder of 1999 and beyond.
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<PAGE> 11
Direct costs include compensation and related fringe benefits for
non-administrative employees (including those 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 $600,000, or 31.6%, from $1.9 million to $2.5 million for the three months
ended March 31, 1998 and 1999, respectively. As a percentage of revenue, direct
costs decreased from 79.2% during the three months ended March 31, 1998 to 61.0%
during the three months ended March 31, 1999. The Clinical Business incurs a
high level of fixed direct costs at its owned research sites, due to the number
of clinical and support personnel required in order to offer clinical services
at these sites. The decrease in direct costs as a percentage of revenue was the
result of GFI's increased level of revenue and its ability to leverage its fixed
personnel costs.
Selling, general and administrative ("SG&A") expenses include all administrative
personnel costs, business development costs, and costs associated with the
growth and quality maintenance of the Affiliated Site Network, and all other
expenses not directly chargeable to a specific contract. Approximately 12% of
the Clinical Business's SG&A expenses were for costs associated with the growth
and quality maintenance of the Affiliated Site Network during the three months
ended March 31, 1999. These Affiliated Site Network costs, which include among
other things expenses related to personnel, travel, advertising, database
management and regulatory compliance, are expensed as incurred. SG&A costs for
the three months ended March 31, 1999 decreased $200,000 to $1.2 million as
compared to $1.4 million during the three months ended March 31, 1998. Of this
decrease, $160,000 was the result of the Company's exiting of its European
operations. The remainder of the decrease was the result of the Company's
reorganization in the first quarter of 1998. As a percentage of revenue,
selling, general and administrative expenses decreased from 58.3% to 29.3% for
the three months ended March 31, 1998 and 1999, respectively. The decrease in
SG&A expenses as a percentage of revenue was partly the result of the Clinical
Business's increased level of revenue being able to absorb its fixed operating
costs.
During the three months ended March 31, 1998, the Clinical Business incurred
special items charges of $810,000 as part of the Company's reorganization plan.
These charges included severance costs for 19 employees who were terminated in
March of 1998, costs associated with the relocation of certain Clinical Business
employees and costs related to a lawsuit settlement with two former Clinical
Business executive officers.
Depreciation and amortization expense decreased from $190,000 for the three
months ended March 31, 1998 to $110,000 during the three months ended March 31,
1999. This decrease was caused by a the decrease in goodwill amortization
resulting from the September 1998 goodwill write-down.
Other expenses for the three months ended March 31, 1999 of $110,000 were
recorded as a result of costs incurred relating to the sale of the Clinical
Business.
Income tax expense for the Clinical Business was $55,000 for the three months
ended March 31, 1998 and $40,000 for the three months ended March 31, 1999.
These taxes were the result of state taxes incurred during both three month
periods.
DataTRAK Business. Revenue for the three months ended March 31, 1999 increased
to $30,000 as compared to $10,000 for the three months ended March 31, 1998. The
increase was the result of $10,000 associated with Sponsor training on the
DataTRAK EDC(TM) software, and an increase of $10,000 in revenue associated of
EDC services preformed on two European clinical trials. Direct costs of revenue,
mainly personnel costs at DataTRAK's German subsidiary ("DataTRAK GmbH"), were
$100,000 and $150,000 during the three months ended March 31, 1998 and 1999,
respectively
SG&A expenses increased from $450,000 to $780,000 for the three months ended
March 31, 1998 and 1999, respectively. This increase was due to a one time
expense of $350,000 associated for services provided by an outside consultant to
assess the market potential of the DataTRAK EDC(TM) software. This
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<PAGE> 12
expense was offset by a deduction of SG&A expenses resulting from the
Company's reorganization in the first quarter of 1998.
During the three months ended March 31, 1998, DataTRAK incurred special items
charges of $30,000 resulting from the Company's first quarter 1998
reorganization and included severance costs for one employee who was terminated.
Depreciation and amortization expense increased from $60,000 during the three
months ended March 31, 1998 to $120,000 during the three months ended March 31,
1999. The increase was the result of the purchase of the DataTRAK EDC(TM)
software, and other assets, as well as capitalized software development costs.
Other Corporate Items. The Company recorded SG&A expenses of $770,000 and
$510,000 during the three months ended March 31, 1998 and 1999, respectively
that were not allocated to either of the Company's operating divisions. The
decrease was due to reduced personnel and other costs resulting from the
Company's reorganization in the first quarter of 1998.
Corporate special items charges relating to the Company's first quarter 1998
reorganization totaled $590,000. These charges included severance costs for nine
employees who were terminated in March of 1998.
Other income decreased $190,000 for the three months ended March 31, 1999
compared to the three months ended March 31, 1998. The decrease was the result
of a $140,000 decrease in interest income caused by the Company's use of cash to
fund its operating losses and other working capital needs, and $50,000 of
expense related to the disposal of obsolete equipment.
LIQUIDITY AND CAPITAL RESOURCES
Since its inception, the Company's principal sources of cash have been cash flow
from operations and proceeds from the sale of equity securities. The Company's
investing activities primarily reflect capital expenditures, acquisitions and
net purchases of short-term investments.
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
received upon completion of negotiated performance milestones throughout the
life of the contract. All amounts received are recorded as a liability (deferred
revenue) until work has been completed and revenue is recognized. Cash receipts
do not necessarily correspond to costs incurred or revenue recognized. 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 $4.2 million at March
31, 1999 and $2.7 million at December 31, 1998. Deferred revenue was $390,000 at
March 31, 1999 and $630,000 at December 31, 1998.
Cash and cash equivalents decreased $870,000 during the three months ended March
31, 1999. This was the result of $2.2 million provided by investing and
financing activities, offset by $3.1 million used in operating activities.
Investing activities included net proceeds of $2.3 million from purchases and
maturities of short-term investments offset by $150,000 used to purchase
property and equipment.
Cash used for operating activities, of $3.1 million, resulted primarily from the
Company's net loss and other cash uses. Cash used in operating activities
includes the Company's net loss, exclusive of non-cash operating items, of
$970,000, a $1.5 million increase in accounts receivable and $210,000 related to
1998 special items charges. Changes in other current assets and liabilities
resulted in a net $420,000 use of cash.
At March 31, 1999, the Company had working capital of $23.6 million, and its
cash, cash equivalents and short-term investments totaled $23.8 million. The
Clinical Business had working capital of $1.8 million at
12
<PAGE> 13
March 31, 1999. The Company's working capital decreased by $900,000 from
December 31, 1998. The decrease was primarily the result of a $2.9 million
decrease in cash, cash equivalents and short-term investments. The decrease in
cash, cash equivalents and short-term investments was offset by the $1.5 million
increase in receivables and a $500,000 decrease in accounts payable in accrued
expenses.
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 were outstanding as of March 31, 1999). 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.
In connection with the sale of the Clinical Business, the Company received $16.8
million on April 20, 1999. These proceeds are subject to certain transaction
costs, and adjustments based on the Clinical Business's working capital at April
20, 1999 and the collection of net accounts receivable during the 180 days
following April 20, 1999. The Company's Board of Directors has determined that
it will distribute a significant portion of the Company's cash to its
shareholders. The amount that will be set aside for this purpose is currently
being determined, and will depend upon the Board's assessment of the amount of
cash that is appropriate to devote to the continued development of DataTRAK. The
Company has not yet determined whether this distribution will be effected
through a share repurchase or a dividend. The Company expects to resolve these
issues in the near future. The Board is also considering a possible sale or
merger of the Company. However, the Company is not currently engaged in any
discussions or negotiations concerning a sale or merger of the Company.
As a result of the sale of the Clinical Business, the Company may be required to
voluntarily delist its Common Shares from quotation and trading on The Nasdaq
National Market ("Nasdaq"), which may impair the liquidity of the trading market
for the Common Shares. However, if the Common Shares are delisted, the Company
may list its Common Shares for trading over-the-counter or may apply for listing
of the Common Shares on the Nasdaq SmallCap Market, subject to Nasdaq's
approval. The Company's liquidity and capital resources would not be materially
effected if it were required to voluntarily delist its Common Shares from
quotation and trading on Nasdaq. However, a delisting of the Common Shares could
have a long-term impact on the Company's ability to raise future capital through
a sale of its Common Shares.
In January 1998, DataTRAK purchased the EDC software now known as DataTRAK
EDC(TM) from EDS for $610,000. The Company is responsible for funding the future
development and testing of this software. The Company will also continue to
invest in the development of the DataTRAK(R) process. DataTRAK's primary source
of cash has been cash generated by the Clinical Business and the maturities of
corporate short-term investments. DataTRAK has had a negative cash flow of
approximately $10.0 million since it began operations in 1997. The Company
anticipates that it's cash needs for operations for the remainder of 1999 will
be approximately $3.5 million, including $800,000 related to the payment of
special items charges recorded in 1998. In addition, the Company anticipates
software development expenditures of $1.5 to $2.0 million over the next two
years for continued commercialization and product development of DataTRAK
EDC(TM). The Company expects such activities will be funded from existing cash
and cash equivalents, maturities of short-term investments, cash flow from
operations, borrowings under its line of credit, as needed, and the proceeds
from the sale of its Clinical Business.
YEAR 2000 READINESS DISCLOSURE
Many existing computer systems and software programs currently in use are coded
to accept only two digit entries in the date code field. These systems and
programs were designed and developed without considering the impact of the
upcoming change in the century. If not corrected, many computer applications
could fail or create erroneous results by or at the Year 2000.
13
<PAGE> 14
The Company understands that as the new millennium approaches it is vital to all
of its Sponsors, Affiliated Sites and suppliers that the Company's internal
information technology ("IT") and non-IT systems are Year 2000 compliant. In
addition, just as important a priority is the compliance of external IT and
non-IT systems and services provided by others to the Company. To meet the above
compliance requirements, the Company has utilized the following methodology
since mid-1997. It has: (1) developed a three-year plan (1997-1999) with Year
2000 IT issues as a priority, (2) established a corporate Year 2000 program, (3)
performed a physical inventory of all IT and non-IT systems and software, (4)
delegated internal Year 2000 evaluation and testing responsibilities within the
Company, (5) assessed its compliance with the above plans on an on-going basis,
(6) identified and categorized any "mission critical" items, (7) repaired or
replaced all non-compliant IT and non-IT systems and services, (8) internally
tested all systems and services for compliance, (9) compiled appropriate
documentation of all testing and vendor compliance statements, (10) queried its
utilities, Sponsors, Affiliated Sites and suppliers as to their readiness and
status, (11) developed a business contingency plan in the event of Year 2000
malfunctions and (12) issued a public Year 2000 disclosure statement on the
Company's web site.
The Company has also established internal policies that have actively informed
its employees of the Year 2000 problem and that assist in procurement of only
new equipment that is Year 2000 compliant.
At this point in the Company's Year 2000 effort, substantially all of the
Company's internal IT and non-IT hardware and software systems have been tested
and either replaced or repaired. The Company expects that all other
non-compliant IT and non-IT systems will either be Year 2000 ready or replaced
by June 30, 1999. There can be no assurance that additional coding errors or
other defects will not be discovered in the future though management believes
the possibility of such discoveries is quite low due to the recent vintage and
uniformity of IT and non-IT systems throughout the Company.
The Company is in the process of determining how it may be impacted by any third
parties' failure to remedy their own Year 2000 issues. The Company has initiated
formal communications with significant Sponsors, suppliers and other third
parties to determine the extent, if any, to which the Company's interface
systems could be impacted by those third-parties' failure to remedy their own
Year 2000 issues. The Company will continue these communications through
mid-1999. Management currently does not anticipate any material adverse impact
on its operations as a result of Year 2000 issues of third parties. However, at
this stage of the review no assurance can be given that the failure by one or
more third parties to become Year 2000 compliant will not have a material
adverse impact on the Company's financial position or results of operations.
Management of the Company believes an effective program for resolving Year 2000
issues in a timely manner is in place. Since it is not possible to anticipate
all possible future outcomes, especially when third parties are involved, there
could be circumstances in which the Company's operations could be interrupted.
In addition, disruptions in the economy in general resulting from Year 2000
issues could also adversely impact the Company. The most significant Year 2000
issue and worst case scenario of concern to the Company has been identified as
being a long-term electrical power disruption. The Company's contingency plans
for large-scale Year 2000 disruptions focuses on two critical high-level
operational issues: (1) The preservation and availability of critical company
data as of December 31, 1999 and (2) the use of manual transaction processing
until all disruptions are eliminated.
To date, the total cost of the Year 2000 systems review has been immaterial to
the Company's financial position and results of operations. Management does not
anticipate incurring any additional costs that would be material to the
Company's financial position and results of operations. As of March 1999, the
Company has not utilized any outside consultants or technical staff to meet its
Year 2000 goals and has no current plans to do so.
14
<PAGE> 15
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 that are based on management's current beliefs, estimates and
assumptions concerning the operations, future results and prospects of the
Company and the clinical pharmaceutical research industry in general. All
statements that address operating performance, events or developments that
management anticipates will occur in the future, including statements related to
future revenue, profits, expenses, income and earnings per share or statements
expressing general optimism about future results, are forward-looking statements
within the meaning of Section 21E of the Securities Exchange Act of 1934
("Exchange Act"). In addition, words such as "expects," "anticipates,"
"intends," "plans," "believes," "estimates," variations of such words, and
similar expressions are intended to identify forward-looking statements. Forward
looking statements are subject to the safe harbors created in the Exchange Act.
Factors that may cause actual results to differ materially from those in the
forward looking statements include the ability of the Company to absorb
corporate overhead and other fixed costs in order to successfully market the
DataTRAK EDC(TM) software; the development and fluctuations in the market for
electronic data capture technology; the degree of the Company's success in
obtaining new contracts; the timing of payments from sponsors and the timing of
sponsor decisions to conduct new clinical trials or cancel or delay ongoing
trials; dependence on key personnel; governmental regulation; the early stage of
the Company's DatatTRAK business and operations; and general economic
conditions. In addition, the Company's success depends on the outcome of various
strategic initiatives 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.
15
<PAGE> 16
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
At a special meeting of shareholders held on April 14, 1999,
the Company's shareholders voted to approve the sale of the
Clinical Business, to change the Company's name from
Collaborative Clinical Research, Inc. to DataTRAK
International, Inc. and to amend the Company's Amended and
Restated 1996 Outside Directors' Stock Option Plan.
The following is a summary of the voting:
<TABLE>
<CAPTION>
Sale of Clinical Change of Amendment of
Votes Business Company's name stock option plan
----- -------- -------------- -----------------
<S> <C> <C> <C>
For 4,835,549 4,833,899 4,209,628
Against 12,675 14,675 549,753
Withheld 1,607 1,257 753,326
</TABLE>
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 March 31, 1999.
16
<PAGE> 17
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.
DataTRAK International, Inc.
----------------------------------------------------
Registrant
Date: 5/14/99 /s/ Jeffrey A. Green
---------------- ----------------------------------------------------
Jeffrey A. Green,
President and Chief Executive Officer and a Director
(Principal Executive Officer)
Date: 5/14/99 /s/ Terry C. Black
---------------- ----------------------------------------------------
Terry C. Black,
Vice President of Finance, Chief Financial Officer,
Treasurer and Assistant Secretary
(Principal Financial Officer)
17
<PAGE> 18
EXHIBIT INDEX
<TABLE>
<CAPTION>
EXHIBIT NO. DESCRIPTION PAGE
- ----------- ----------- ----
<S> <C> <C>
2.1 Asset Purchase Agreement, dated December 21, 1998 among Collaborative
Clinical Research, Inc., GFI Pharmaceutical Services, Inc., Collaborative
Holdings, Inc., DataTRAK, Inc. and The West Company, Incorporated (D)
3.1 Fifth Amended and Restated Articles of Incorporation (B)
3.2 Form of Certificate of Amendment to the Fifth Amended and Restated
Articles of Incorporation (D)
3.3 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 Amendment to the Credit Agreement between the Company and Key
Bank, dated February 5, 1999 (E)
4.4 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).
(D) Incorporated herein by reference to the appropriate exhibit to the
Company's Schedule 14A, dated March 17, 1999 (Commission File No.
000-20699)
(E) Incorporated herein by reference to the appropriate exhibit to the
Company's Form 10-K for the year ended December 31, 1998 (Commission
file No. 000-20699).
E-1
<PAGE> 1
EXHIBIT 15.1
INDEPENDENT ACCOUNTANTS' REVIEW REPORT
The Board of Directors and Shareholders
DataTRAK International, Inc.
We have reviewed the accompanying condensed consolidated balance sheet of
DataTRAK International (formerly Collaborative Clinical Research, Inc.),
Inc. and subsidiaries (the "Company") as of March 31, 1999, and the related
condensed consolidated statements of operations and cash flows for the
three-month periods ended March 31, 1998 and 1999. 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 DataTRAK International, Inc. and
subsidiaries as of December 31, 1998, 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 February 5, 1999, 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, 1998 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
April 23, 1999
<TABLE> <S> <C>
<ARTICLE> 5
<LEGEND>
THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM MARCH 31,
1999 CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED) AND IS QUALIFIED IN
ITS ENTIRETY BY REFERENCE TO SUCH FINANCIAL STATEMENTS.
</LEGEND>
<S> <C>
<PERIOD-TYPE> 3-MOS
<FISCAL-YEAR-END> DEC-31-1999
<PERIOD-START> JAN-01-1999
<PERIOD-END> MAR-31-1999
<CASH> 23,785,362
<SECURITIES> 0
<RECEIVABLES> 4,407,221
<ALLOWANCES> 176,342
<INVENTORY> 0
<CURRENT-ASSETS> 28,228,417
<PP&E> 3,875,506
<DEPRECIATION> 1,626,167
<TOTAL-ASSETS> 31,813,843
<CURRENT-LIABILITIES> 4,658,901
<BONDS> 0
0
0
<COMMON> 49,705,942
<OTHER-SE> (22,551,000)
<TOTAL-LIABILITY-AND-EQUITY> 31,813,843
<SALES> 0
<TOTAL-REVENUES> 4,179,648
<CGS> 0
<TOTAL-COSTS> 2,649,177
<OTHER-EXPENSES> 2,904,228
<LOSS-PROVISION> 18,000
<INTEREST-EXPENSE> 0
<INCOME-PRETAX> (1,069,004)
<INCOME-TAX> 40,000
<INCOME-CONTINUING> (1,109,004)
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> (1,109,004)
<EPS-PRIMARY> (0.173)
<EPS-DILUTED> (0.173)
</TABLE>
