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FORM 10-Q
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
[ 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 33-69586
CLINTRIALS RESEARCH INC.
(Exact name of registrant as specified in its charter)
Delaware 62-140601
(State or other jurisdiction (I.R.S. Employer
of incorporation or organization) Identification Number)
20 Burton Hills Boulevard
Suite 500
Nashville, Tennessee 37215
(Address of principal executive offices)
(Zip Code)
(615) 665-9665
(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
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As of April 24, 1997, there were 17,879,408 shares of ClinTrials Research Inc.
common stock outstanding.
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CLINTRIALS RESEARCH INC.
TABLE OF CONTENTS
PART I. FINANCIAL INFORMATION.............................................................1
Item 1. Financial Statements (Unaudited).......................................1
Condensed Consolidated Balance Sheets...........................................1
Condensed Consolidated Statements of Operations.................................2
Condensed Consolidated Statements of Cash Flows.................................3
Notes to Condensed Consolidated Financial Statements............................4
Item 2. Management's Discussion and Analysis of Financial Conditions and
Results of Operations........................................................5
PART II. OTHER INFORMATION..............................................................12
Item 5. Other Information.....................................................12
Item 6. Exhibits and Reports on Form 8-K......................................12
SIGNATURES...............................................................................13
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PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS (UNAUDITED)
ClinTrials Research Inc.
Condensed Consolidated Balance Sheets
(in thousands, except for share data)
December 31, March 31,
1996 1997
Assets (Note) (Unaudited)
------------ ----------
Current assets:
Cash and cash equivalents $ 38,087 $ 27,726
Accounts receivable 37,270 40,809
Advanced payments to investigators 549 263
Deferred income taxes 2,361 2,211
Other current assets 3,028 2,907
-------- --------
Total current assets 81,295 73,916
Property, Plant and Equipment:
Land, buildings and leasehold improvements 17,448 17,476
Equipment 20,493 22,018
Furniture and fixtures 4,415 4,635
-------- --------
42,356 44,129
Less accumulated depreciation and amortization 8,265 9,408
-------- --------
34,091 34,721
Other assets:
Excess of purchase price over net assets acquired 41,493 40,773
Other assets 74 99
-------- --------
41,567 40,872
-------- --------
$156,953 $149,509
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Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable $ 6,133 $ 4,237
Advance billings 14,797 9,074
Payables to investigators 1,336 3,475
Accrued expenses 4,397 3,567
Income Taxes Payable 2,286 1,595
-------- --------
Total current liabilities 28,949 21,948
Deferred income taxes 2,602 2,398
Commitments and contingencies -- --
Stockholders' equity
Preferred Stock, $.01 par value - 1,000,000 shares
authorized; no shares issued or outstanding -- --
Common Stock, $.01 par value - 30,000,000 shares
authorized; issued and outstanding 17,864,258
and 17,871,369 in 1996 and 1997, respectively 179 179
Additional paid-in capital 126,775 126,819
Retained earnings (deficit) (2,535) (1,787)
Cumulative foreign currency translation adjustments 983 (48)
-------- --------
Total stockholders' equity 125,402 125,163
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$156,953 $149,509
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See notes to condensed consolidated financial statements
Note: The balance sheet at December 31, 1996 has been derived from the
audited financial statements at that date.
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ClinTrials Research Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
(in thousands)
Three Months
Ended March 31,
-----------------------
1996 1997
-------- --------
Revenues:
Service revenue $ 26,397 $ 37,277
Less subcontract costs 8,727 8,674
-------- --------
Net service revenue 17,670 28,603
Operating costs:
Direct costs 10,526 17,884
Selling, general and administrative costs 4,750 8,896
Depreciation and amortization 700 1,294
-------- --------
Income from operations 1,694 529
Other income (expense):
Interest income 215 353
Interest expense (14) (11)
-------- --------
Income before income taxes 1,895 871
Provision for income taxes 782 123
-------- --------
Net income $ 1,113 $ 748
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Earnings per common and common equivalent share:
Net income $ 0.08 $ 0.04
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Weighted average shares outstanding (see exhibit 11) 13,778 18,272
See notes to condensed consolidated financial statements
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ClinTrials Research Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
(in thousands, except for share data)
Three Months
Ended March 31,
-----------------------
1996 1997
-------- --------
Net income $ 1,113 $ 748
Adjustments to reconcile net income
to net cash provided by (used in) operating activities:
Depreciation and amortization 700 1,533
Change in operating assets and liabilities (728) (10,187)
Other operating activities (34) (400)
-------- --------
Net cash provided by (used in) operating activities 1,051 (8,306)
Cash flows from investing activities:
Purchasing of property, plant and equipment (net) (1,331) (2,099)
-------- --------
Net cash used in investing activities (1,331) (2,099)
Cash flows from financing activities:
Proceeds from issuance of common stock 80 44
-------- --------
Net cash provided by (used in) financing activities 80 44
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Net increase (decrease) in cash and cash equivalents (200) (10,361)
Cash, cash equivalents, and held-to-maturity securities at
beginning of period 17,031 38,087
-------- --------
Cash, cash equivalents, and held-to-maturity securities at
end of period $ 16,831 $ 27,726
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CLINTRIALS RESEARCH INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Note 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 fair presentation have
been included. Operating results for the three-month period ended March 31, 1997
are not necessarily indicative of the results that may be expected for the year
ended December 31, 1997. For further information, refer to the consolidated
financial statements and footnotes thereto included in the Company's annual
report on Form 10-K for the year ended December 31, 1996.
Note 2 - Earnings per Share
The earnings per share calculations for the three-month period ending March
31, 1997 are based on 17,867,450 weighted average shares outstanding plus
404,562 common stock equivalent shares related to the 1989 Stock Option Plan.
The Company's stock is currently traded in the Nasdaq Stock Market and sale
information is included on Nasdaq National Market Issues System under the symbol
"CCRO".
Note 3 - Acquisition
On July 31, 1996, the Company purchased for $65 million in cash all of the
assets and assumed certain liabilities (the "Acquisition") of Bio-Research
Laboratories Ltd. of Montreal, Quebec ("Bio-Research"). The Acquisition was
financed with the proceeds of a public offering of 4,485,000 shares of the
Company's common stock at $20 per share on July 24, 1996 (as adjusted for the
Company's 3-for-2 stock split). Net proceeds to the Company from the offering
were approximately $84.9 million, $65 million of which was used to fund the
Acquisition. The operations of Bio-Research are included in the Company's
results of operations from the date of Acquisition.
The Acquisition was accounted for under the purchase method of accounting.
The purchase price was allocated to the tangible and intangible assets
acquired and liabilities assumed based upon their fair values. The purchase
price allocation was as follows (in thousands):
Current assets $16,468
Current liabilities assumed (9,635)
Property, Plant and Equipment 23,141
Excess purchase price over net assets acquired 35,026
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$65,000
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The following represents the unaudited pro forma results of operations with
increased amortization of intangible assets as if the Acquisition had occurred
as of January 1, 1996, as compared to actual results for the period ended March
31, 1997 (in thousands, except for per share data):
Three Months
Ended March 31,
1996 1997
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Net service revenue $23,994 $28,603
Income before tax 2,017 871
Net income 1,411 748
Earnings per common and common equivalent
share $ 0.08 $ 0.04
Weighted average shares outstanding 17,028 18,272
The pro forma information given above does not purport to be indicative of
the results that actually would have been obtained if the operations were
combined during the pro forma period actually presented, and is not intended
to be a projection of future results or trends.
Note 4 - Stock Split
On October 25, 1996, the Board of Directors declared a 3-for-2 stock split
to be effected in the form of a stock dividend of one-half share for each share
of Company common stock outstanding as of the record date, November 11, 1996.
The dividend was distributed to shareholders on November 25, 1996. Earnings per
common and common equivalent share referred to in the financial statements and
notes hereto have been adjusted retroactively to give effect to the stock split.
Note 5 - FAS 128
In February 1997, the Financial Accounting Standards Board issued STATEMENT
No. 128, Earnings per Share, which is required to be adopted on December 31,
1997. At that time, the Company will be required to change the method currently
used to compute earnings per share and to restate all prior periods. Under the
new requirements for calculating primary earnings per share, the dilutive effect
of stock options will be excluded. The impact is expected to result in no
increase in primary earnings per share for the first quarter ended March 31,
1997 and March 31, 1996. The impact of Statement 128 on the calculation of fully
diluted earnings per share for these quarters is not expected to be material.
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
The following discussion should be read in conjunction with "Management's
Discussion and Analysis of Financial Condition and Results of Operations"
included in the Company's annual report on Form 10-K for the year ended December
31, 1996.
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The information set forth and discussed below for the three-month period
ended March 31, 1997 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) considered necessary for a
fair presentation of such information. The Company's results of operations for a
particular quarter may not be indicative of the results expected during other
quarters or for the entire year.
OVERVIEW
The Company is a full-service contract research organization ("CRO")
serving the pharmaceutical, biotechnology and medical device industries. The
Company designs, monitors and manages preclinical and clinical trials, provides
clinical data management and biostatistical services and offers product
registration services throughout the United States, Canada and Europe. The
Company generates substantially all of its revenue from the preclinical and
clinical testing of new pharmaceutical and biotechnology products.
The Company's contracts are typically fixed priced, multi-year contracts
that usually require a portion of the contract amount to be paid at or near the
time the trial is initiated. The Company generally bills its clients upon the
completion of negotiated performance requirements and, to a lesser extent, on a
date certain basis. The Company's contracts generally may be terminated with or
without cause. In the event of termination, the Company is typically entitled to
all sums owed for work performed through the notice of termination and all costs
associated with termination of the study. In addition, some of the Company's
contracts provide for an early termination fee, the amount of which usually
declines as the trial progresses. Termination or delay in the performance of a
contract occurs for various reasons, including, but not limited to, unexpected
or undesired results, inadequate patient enrollment or investigator recruitment,
production problems resulting in shortages of the drug, adverse patient
reactions to the drug, or the client's decision to deemphasize a particular
trial.
Revenue for contracts is recognized on a percentage of completion basis as
work is performed. Revenue is affected by the mix of trials conducted and the
degree to which labor and facilities are utilized. The Company routinely
subcontracts with third party investigators in connection with multi-site
clinical trials and with other third party service providers for laboratory
analysis and other specialized services. These costs are passed through to
clients and, in accordance with industry practice, are included in service
revenue. Subcontractor services may vary significantly from contract to
contract; therefore, changes in service revenue may not be indicative of trends
in revenue growth. Accordingly, the Company views net service revenue, which
consists of service revenue less subcontractor costs, as its primary measure of
revenue growth. The Company has had, and will continue to have, certain clients
from which at least 10 percent of the Company's overall revenue is generated
over multiple contracts. Such concentrations of business are not uncommon within
the CRO industry.
The Company's quarterly operating results may fluctuate as a result of
factors such as delays experienced in implementing or completing particular
clinical trials and termination of clinical trials, the costs associated with
integrating acquired operations, foreign exchange fluctuations, as well as the
costs associated with opening new offices. Since a high percentage of the
Company's operating costs are relatively fixed while revenue is subject to
fluctuation, minor variations in the timing of
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contracts or the progress of clinical trials (both delays and accelerations) may
cause significant variations in quarterly operating results. Results of one
quarter are not necessarily indicative of results for the next quarter.
Since it is common for clients to authorize projects and the Company to
commence providing services before a contract is signed, the Company believes
reported backlog should consist of anticipated net revenue from uncompleted
projects which have been authorized by the client, through a written contract or
otherwise. At March 31, 1997, backlog was approximately $102.1 million, as
compared to approximately $98.8 million at March 31, 1996. The Company believes
that backlog is not a consistent indicator of future results because backlog can
be affected by a number of factors, including the variable size and duration of
projects, many of which are performed over several years. Additionally, projects
may be terminated by the client or delayed by regulatory authorities for many
reasons, including unexpected test results. Moreover, the scope of a project can
change during the course of a study.
The Company's core business in the United States has experienced
considerable growth, reflecting both an expansion of the Company's client base
and an increase in the number of projects under management. During 1996, the
Company expanded its ability to perform international clinical trials by
opening offices in Australia, Chile, France, and Israel. The Company plans to
continue to develop these and other operations abroad. This will require
additional investments in marketing and infrastructure and may include the
establishment of other new offices. Currently, the Company anticipates each new
office will incur losses through its first twelve months of operations.
Contracts between the Company's subsidiaries (primarily in Canada and to a
lesser extent in the United Kingdom) and their clients may be denominated in a
currency other than the local currency of the subsidiary. Because substantially
all of the subsidiaries' expenses are paid in the local currency of the
subsidiary, such subsidiaries' earnings related to these contracts could be
affected by fluctuations in exchange rates. Generally, the Company attempts to
contractually limit its future foreign exchange risks with its clients. In
addition, the Company may use future foreign exchange contracts to hedge the
risk of changes in foreign currency exchange rates associated with contracts in
which the expenses for providing services are incurred in one currency and paid
for by the client in another currency. The Company expects its subsidiaries
located outside the United States to generate over 40% of its net revenue
beginning in 1997, at least half of which will be generated by the Company's
Canadian subsidiary. Therefore, fluctuations in exchange rates may have a
material affect on the earnings of the Company.
The Company's consolidated financial statements are denominated in U.S.
dollars and, accordingly, changes in the exchange rates between the Company's
subsidiaries' local currency and the U.S. dollar will affect the translation of
such subsidiaries' financial results into U.S. dollars for purposes of reporting
the Company's consolidated financial results. Translation adjustments are
reported as a separate section of stockholders' equity. Such adjustments may in
the future be material to the Company's financial statements.
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RESULTS OF OPERATIONS
Quarter Ended March 31, 1997 Compared to Quarter Ended March 31, 1996
Net service revenue increased 61.9% to $28.6 million in the first quarter
of 1997 from $17.7 million in the same period of 1996. Excluding $8.9 million of
revenue recognized in the first quarter of 1997 related to Bio-Research
(acquired July 31, 1996) net service revenue increased 11.5%. This increase
resulted primarily from an increase in the number of contracts under management
and in the number of clients served. The backlog at March 31, 1997 was $102.1
million, representing 407
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contracts from 113 clients, as compared to $98.8 million at March 31, 1996,
representing 217 contracts from 58 clients. In February, the Company
experienced the cancellation of three projects with total backlog of
approximately $27 million which followed similar project cancellations of $10
million in the fourth quarter of 1996. None of the cancellations were related
to service or quality problems.
Direct costs increased 69.9% to $17.9 million in the first quarter of 1997
from $10.5 million in the same period of 1996, and increased as a percentage of
net service revenue to 62.5% from 59.6%. Direct costs, as a percentage of net
revenue, may fluctuate from one period to the next based on the mix of contracts
in the backlog as of any given date. In addition, direct costs may fluctuate due
to changes in labor and facility utilization resulting from the growth the
Company has experienced.
Selling, general and administrative costs increased 87.3% to $8.9 million
in the first quarter of 1997 from $4.8 million in the same period of 1996, and
increased as a percentage of net service revenue to 31.1% from 26.9%. The
increase as a percentage of net revenue is primarily attributable to the
inclusion of Bio-Research and the relatively lower levels of revenue resulting
from the project cancellations discussed above. Selling, general and
administrative costs, which primarily includes compensation for administrative
employees, facilities costs, and marketing costs, are relatively fixed in the
near term while revenue is subject to fluctuation, therefore, minor variations
in the timing of contracts or the progress of clinical trials (both delays and
accelerations) may cause significant variations in quarterly operating results.
In addition, the Company has incurred and will continue to incur costs related
to expanded infrastructure required to open new offices as described
previously.
Depreciation and amortization expense increased 84.9% to $1.3 million in
the first quarter of 1997 compared to $700,000 in the same period of 1996.
Interest income, net of interest expense, increased to $342,000 in the
first quarter of 1997 from $201,000 in the same period of 1996.
Consolidated income before income taxes decreased to $871,000 in the first
quarter of 1997 from $1.9 million in the same period of 1996. The provision for
income taxes was $123,000 in the first quarter of 1997 as compared to $782,000
in the same period of 1996 resulting in effective tax rates of 14% and 41%,
respectively. The significant items that create the difference between the
Company's federal statutory and effective tax rates are state and local taxes,
research and development tax credits generated by the Company's Canadian
subsidiary, tax-exempt interest income, nondeductible amortization of goodwill,
and foreign net operating losses not previously recognized. The Company, in
general, will not record a tax asset for losses incurred in its foreign
operations until such time, if any, that it has three years of profits in the
applicable jurisdiction. However, the Company will recognize a tax benefit for
losses incurred in its foreign operations as the subsidiary generates taxable
income to the extent of the cumulative losses.
LIQUIDITY AND CAPITAL RESOURCES
The Company's primary operating cash needs on both a short-term and
long-term basis are the payment of salaries, office rent and travel expenses, as
well as capital expenditures. Capital expenditures have primarily been made for
computer system additions and upgrades and computer equipment for new employees.
Capital expenditures were $2.0 million in 1994, $3.8 million in 1995, $7.3
million in 1996, and are estimated to be $11.0 million in 1997. The Company has
historically
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financed these expenditures, as well as acquisitions, with cash flow from
operations, issuances of equity securities and borrowings under its Credit
Facility as defined below. The Company utilizes its working capital to finance
these expenditures pending receipt of its receivables. Contract payments by the
Company's clients vary according to the terms of each contract.
The Company's contracts usually require a portion of the contract amount to
be paid at or near the time the trial is initiated. Payments are generally made
upon the completion of negotiated performance requirements and, to a lesser
extent, on a date certain basis throughout the life of the contract. Cash
receipts do not correspond to costs incurred and revenue recognition (which is
based on cost-to-cost type of percentage of completion accounting). Therefore,
the Company's cash flow is influenced by the interaction of changes in
receivables and advance billings. The Company typically receives a low volume of
large-dollar cash receipts, and historically has received significant cash
receipts from its clients in the fourth quarter.
The Company has experienced a trend, which it expects will continue, in
which clients place less emphasis on prepayments and greater emphasis on
negotiated performance requirements. This has increased and, may continue to
increase, days sales outstanding in accounts receivable. However, the Company
does not expect this trend to have a significant impact on its ability to
maintain its overall working capital. The number of days sales outstanding in
accounts receivable was 86 days at March 31, 1997, 90 days at December 31, 1996,
and 77 days at March 31, 1996. The number of days sales outstanding in accounts
receivable net of advanced billings was 61 days at March 31, 1997, 52 days at
December 31, 1996, and 6 days at March 31, 1996. The Company believes its days
sales outstanding in accounts receivable to be comparable to the average for the
CRO industry.
During the three months ended March 31, 1997, net cash used by operating
activities totaled $8.3 million, primarily due to an increase in accounts
receivable of $3.5 million, a decrease in advance billings of $5.7 million, a
decrease in accounts payable of $1.9 million and a decrease in other current
liabilities of $1.5 million, which was partially offset by net income, net of
non-cash expenses, of $2.2 million and an increase in net payables to
investigators of $2.4 million.
Cash used in investing activities of $2.1 million during the three months
ended March 31, 1997 consisted principally of capital expenditures.
The Company had cash, cash equivalents and held-to-maturity securities of
$27.7 million at March 31, 1997 as compared to $16.8 million at March 31, 1996.
The Company has domestic and foreign lines of credit ("Credit Facility")
with banks totaling approximately $13.7 million. The lines are collateralized by
the Company's assets and bear interest at the respective banks' prime interest
rates. There were no borrowings outstanding under the lines of credit at March
31, 1997. Borrowings available under the lines of credit are subject to certain
financial and operating covenants.
The Company expects to continue expanding its operations through internal
growth and strategic acquisitions. The Company expects such activities will be
funded from existing cash, cash equivalents, held-to-maturity securities, cash
flow from operations, and available borrowings under its Credit Facility. The
Company estimates that such sources of cash will be sufficient to fund the
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Company's current operations, including expansions of its foreign operations, at
least through 1997, although some pressure on cash reserves is expected over the
course of the year resulting from project cancellations discussed previously.
There may be acquisition or other growth opportunities which require additional
external financing, and the Company may from time to time seek to obtain
additional funds from public or private issuances of equity or debt securities.
There can be no assurances that such financings will be available on terms
acceptable to the Company.
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PART II. OTHER INFORMATION
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
(a) Exhibits
The exhibits furnished with this report are listed in
the Exhibit Index located elsewhere.
(b) Reports on Form 8-K
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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.
CLINTRIALS RESEARCH INC.
Date: May 14, 1997 By: /s/ William C. O'Neil, Jr.
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William C. O'Neil, Jr.
Chairman of the Board, President,
and Chief Executive Officer
Date: May 14, 1997 By: /s/ Mary A. Chaput
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Mary A. Chaput
Chief Financial Officer
(Principal Financial and Accounting Officer)
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EXHIBIT INDEX
Exhibit No. Page
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11 Computation of Earnings Per Common and E-1
Common Equivalent Share
27 Financial Data Schedule (for SEC use only) E-3
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