SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934
For Quarter Ended September 30, 1996 Commission File Number 0-8672
ST. JUDE MEDICAL, INC.
(Exact name of registrant as specified in its charter)
MINNESOTA 41-1276891
(State or other jurisdiction (I.R.S. Employer Identification No.)
of incorporation or organization)
One Lillehei Plaza, St. Paul, Minnesota 55117
(Address of principal executive offices)
(612) 483-2000
(Registrant's telephone number, including area code)
Not Applicable
(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, and (2) has been subject to such filing
requirements for the past 90 days.
YES __X__ NO _____
The number of shares of common stock, par value $.10 per share, outstanding at
November 4, 1996 was 80,985,671.
This Form 10-Q consists of 11 pages consecutively numbered.
The Exhibit Index to this Form 10-Q is set forth on page 11.
PART I FINANCIAL INFORMATION
ST. JUDE MEDICAL, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Dollars in thousands, except per share amounts)
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 Rule 10-01 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 months ended September
30, 1996 are not necessarily indicative of the results that may be expected for
the full year ended December 31, 1996. 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, 1995.
NOTE 2 - ACQUISITIONS
Effective May 31, 1996, the Company acquired Daig Corporation, a Minnetonka,
Minnesota based manufacturer of specialized cardiovascular devices for the
electrophysiology and interventional cardiology markets.
Each share of Daig common stock was converted into approximately .652 shares of
St. Jude Medical common stock. The Company issued 9,929,897 shares to Daig
shareholders. The transaction was accounted for as a pooling of interests. The
accompanying financial statements, for all periods presented, are presented on a
pooled basis.
The results of Daig's operations have been included in the condensed
consolidated results of operations as if the acquisition had occurred at the
beginning of 1995. These results are not necessarily indicative of the results
that would have occurred had the acquisition actually taken place at the
beginning of 1995, or of the expected future results of operations.
On January 5, 1996, the Company acquired The Heart Valve Company, previously a
50% owned joint venture with Hancock Jaffee Laboratories (HJL), as well as
certain assets of HJL. Under the agreement, the Company paid $1,000 and issued
149,153 shares of its common stock to HJL shareholders. The acquisition was
accounted for as a purchase and the resulting purchased research and development
charge of $5,000 was recorded in the first quarter 1996.
On September 23, 1996, the Company acquired the business of Biocor(R) Industria
E Pesquisas Ltd., a manufacturer of tissue heart valves for $4,000 in cash and
an earn-out which could result in additional cash payments of up to $4,000 over
the next three years. The acquisition will be accounted for as a purchase and a
purchased research and development charge will be taken in the fourth quarter.
NOTE 3 - CONTINGENCIES
The Company is involved in various products liability lawsuits, claims and
proceedings of a nature considered normal to its business. The Company's
products liability insurance carrier has denied coverage for two pacemaker lead
models and has filed suit against the Company seeking rescission of a products
liability policy covering Pacesetter's business from October 1, 1994 through
December 31, 1995. The Company was a codefendant in a 1995 class action suit
with respect to these leads. This case was settled in November 1995 and the
Company's share of the settlement is estimated to be approximately $5 million.
This case is more fully described in Item I Part II of this Quarterly Report on
Form 10-Q. Additional claims could be filed by patients with these leads who
were not class members. Further, claims may be filed in the future relative to
events currently unknown to management. Management believes any losses that
might be sustained from such actions would not have a material adverse effect on
the Company's liquidity or financial position, but could potentially be material
to the net income of a particular future period if resolved unfavorably.
The Internal Revenue Service ("IRS") is currently examining the Company's
1992-1994 federal income tax returns. In addition, the IRS has completed an
audit examination of the Company's 1990-1991 federal income tax returns and has
proposed an adjustment of approximately $16,600 in additional taxes. The
proposed adjustment relates primarily to the Company's Puerto Rican operations.
It is likely that similar adjustments will be proposed for subsequent years. The
Company is vigorously contesting the proposed adjustments and expects that the
ultimate resolution will not have a material adverse effect on its financial
position, liquidity or net income.
NOTE 4 - SUBSEQUENT EVENTS
On October 23, 1996, St. Jude Medical, Inc. ("St. Jude") entered into definitive
agreements to acquire substantially all of the assets of Telectronics Pacing
Systems, Inc. and Medtel, a distribution company, both wholly owned subsidiaries
of Pacific Dunlop, Ltd. ("Pacific Dunlop"). Also on October 23, 1996, the
Company entered into a definitive agreement with Intermedics, Inc.
("Intermedics") to acquire certain intellectual property rights. The Intermedics
agreement also provided for settlement of intellectual property and other legal
disputes between Intermedics and Ventritex, as well as between Intermedics and
Pacesetter.
In addition, on October 23, 1996, St. Jude entered into a definitive agreement
providing for the merger of Ventritex, Inc. ("Ventritex") into Pacesetter, Inc.
("Pacesetter"), a wholly owned subsidiary of St. Jude. Each outstanding share of
Ventritex common stock will be converted into .6 share of St. Jude common stock.
The Ventritex transaction remains subject to expiration of the applicable
Hart-Scott-Rodino waiting period and is expected to close in the first quarter
1997. The Pacific Dunlop transaction is expected to close in the fourth quarter
1996.
The Pacific Dunlop transactions will be accounted for under purchase accounting.
The Ventritex transaction will be accounted for under pooling of interest
accounting. The Company expects to incur significant charges in connection with
these acquisitions.
ST. JUDE MEDICAL, INC.
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
(Amounts in thousands, except per share amounts)
(Unaudited)
THREE MONTHS NINE MONTHS
ENDED ENDED
SEPTEMBER 30 SEPTEMBER 30
----------------------- -----------------------
1996 1995 1996 1995
-------- --------- -------- ---------
Net sales $193,846 $ 186,176 $596,091 $ 570,386
Cost of sales 59,053 56,401 182,931 177,322
-------- --------- -------- ---------
Gross profit 134,793 129,775 413,160 393,064
Selling, general & administrative 62,610 61,043 195,740 185,220
Research & development 17,365 17,907 53,507 53,590
Purchased research & development -- -- 5,000 --
-------- --------- -------- ---------
Operating profit 54,818 50,825 158,913 154,254
Other income (expense) 1,021 (897) 12,367 (5,546)
-------- --------- -------- ---------
Income before taxes 55,839 49,928 171,280 148,708
Income tax provision 19,544 15,528 59,948 46,060
-------- --------- -------- ---------
Net income $ 36,295 $ 34,400 $111,332 $ 102,648
======== ========= ======== =========
Earnings per share:
Primary $ .44 $ .42 $ 1.36 $ 1.27
======== ========= ======== =========
Fully diluted $ .44 $ .42 $ 1.36 $ 1.27
======== ========= ======== =========
Shares outstanding
Primary 81,967 81,358 81,754 80,846
Fully diluted 82,360 81,546 82,010 81,049
See notes to condensed consolidated financial statements.
ST. JUDE MEDICAL, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Dollars in thousands, except per share amounts)
SEPTEMBER 30 DECEMBER 31
1996 1995
(Unaudited) (See Note)
------------ -----------
ASSETS
Current assets:
Cash and cash equivalents $ 22,442 $ 34,767
Marketable securities 143,480 152,615
Accounts receivable, less allowance
(1996 - $6,642; 1995 - $9,328) 179,286 169,690
Inventories
Finished goods 93,078 82,176
Work in process 23,670 27,544
Raw materials 43,484 53,583
----------- -----------
Total inventories 160,232 163,303
Other current assets 35,210 31,839
----------- -----------
Total current assets 540,650 552,214
Property, plant and equipment 271,345 217,589
Less accumulated depreciation (70,790) (55,519)
----------- -----------
Net property, plant and equipment 200,555 162,070
Other assets 318,060 339,532
----------- -----------
TOTAL ASSETS $ 1,059,265 $ 1,053,816
=========== ===========
LIABILITIES & SHAREHOLDERS' EQUITY
Accounts payable and accrued expenses $ 191,977 $ 197,443
Long-term debt 0 120,000
Contingencies
Shareholders' equity:
Preferred stock, par value $1.00 per share -
25,000,000 shares authorized; no shares issued
Common stock, par value $.10 per share -
250,000,000 shares authorized; issued and
outstanding 1996 - 80,976,337 shares; 1995 -
79,921,597 shares 8,098 7,992
Additional paid-in capital 61,888 34,769
Retained earnings 791,372 680,042
Cumulative translation adjustment 4,758 4,319
Unrealized gain on available-for-sale securities 1,612 9,691
Receivable - stock issued (440) (440)
----------- -----------
Total shareholders' equity 867,288 736,373
----------- -----------
TOTAL LIABILITIES & SHAREHOLDERS' EQUITY $ 1,059,265 $ 1,053,816
=========== ===========
NOTE: The balance sheet at December 31, 1995 has been derived from the audited
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.
ST. JUDE MEDICAL, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Dollars in thousands)
(Unaudited)
NINE MONTHS ENDED
SEPTEMBER 30
-------------------------
1996 1995
--------- ---------
Operating Activities:
Net income $ 111,332 $ 102,648
Depreciation and amortization 32,281 31,500
Purchased research and development 5,000 --
Gain on sale of business (10,486) --
Working capital change (16,560) 4,973
--------- ---------
Net cash provided by operating activities 121,567 139,121
--------- ---------
Investment Activities:
Purchases of property, plant and equipment (58,237) (24,311)
Sales of available-for-sale securities, net 9,000 5,623
Acquisitions, net of cash acquired (7,430) 13,000
Proceeds from sale of business 24,204 --
Other investing activities (2,503) (10,950)
--------- ---------
Net cash used in investing activities (34,966) (16,638)
--------- ---------
Financing Activities:
Proceeds from exercise of stock options 21,225 5,133
Repayment of long-term debt (120,000) (115,000)
--------- ---------
Net cash used in financing activities (98,775) (109,867)
--------- ---------
Effect of currency exchange rate changes on cash (151) 907
--------- ---------
Increase (decrease) in cash and cash equivalents (12,325) 13,523
Cash and cash equivalents at beginning of year 34,767 20,086
--------- ---------
Cash and cash equivalents at end of period $ 22,442 $ 33,609
========= =========
See notes to condensed consolidated financial statements.
MANAGEMENT DISCUSSION AND ANALYSIS
OF RESULTS OF OPERATIONS AND FINANCIAL CONDITION
(Dollars in thousands, except per share amounts)
RESULTS OF OPERATIONS:
NET SALES. Net sales for the third quarter 1996 totalled $193,846, a $7,670 or
4.1% increase over net sales in the third quarter 1995. Excluding net sales from
the cardiac assist division which was sold in January 1996, third quarter net
sales increased 5.6% over the prior year comparable period. For the first nine
months of 1996, net sales totalled $596,091, a $25,705 or 4.5% increase over net
sales in the first nine months of 1995. Unfavorable foreign currency effects due
to the stronger U.S. dollar reduced 1996 net sales compared to 1995 by
approximately $1,100 and $2,200 for the quarter and first nine months,
respectively.
Third quarter 1996 heart valve net sales were slightly higher than the third
quarter 1995 which had included a significant sale into Iran. The U.S. embargo
on goods sold to Iran continues to preclude further sales into that market.
Exclusive of the Iranian sale, third quarter 1996 net sales increased 5.6% from
third quarter 1995 levels. For the first nine months, 1996 heart valve net sales
increased $6,698, or 3.4% over 1995 levels. The net sales increases were mainly
attributable to higher mechanical heart valve unit sales into developing markets
and more tissue heart valve sales due to expanded product offerings.
Pacesetter third quarter 1996 net sales increased 7.4% compared to the third
quarter 1995. For the first nine months, 1996 net sales increased by $21,926, or
6.5%. The increases over 1995 resulted principally from higher unit sales in all
major geographic regions, which were partially offset by lower average selling
prices.
GROSS PROFIT. Third quarter 1996 gross profit totalled $134,793 or 69.5% of net
sales, as compared to $129,775, or 69.7% of net sales during the comparable 1995
period. For the first nine months of 1996 and 1995, gross profit was $413,160 or
69.3% of net sales, and $393,064 or 68.9% of net sales, respectively. The lower
quarterly gross profit margin resulted mainly from the negative foreign currency
impact on net sales, average selling price decreases due to increasing sales in
developing markets and pricing pressure in the cardiac rhythm business. On a
year-to-date basis, the 1996 gross profit margin improved over 1995 because of
the elimination of a 2% mechanical heart valve royalty payment and continuing
manufacturing efficiencies, which were partially offset by the items noted above
for the quarter.
SELLING, GENERAL & ADMINISTRATIVE. Selling, general and administrative (SG&A)
expenses increased in the third quarter 1996 to $62,610, a $1,567 or 2.6%
increase over the third quarter 1995. As a percentage of net sales, 1996 SG&A
decreased to 32.3% from 32.8% in 1995. On a year-to-date basis, 1996 SG&A
expenses totalled $195,740, a $10,520, or 5.7% increase over 1995. The increases
resulted primarily from the establishment of a direct sales organization in
Canada, infrastructure investments in the European and Asia Pacific markets and
enhancements to information technology systems.
RESEARCH AND DEVELOPMENT. Third quarter 1996 research and development (R&D)
expenses were $17,365, a $542 decrease from the third quarter 1995. The first
nine months of 1996 R&D expenses totalled $53,507, an $83 decrease from the 1995
comparable period. The quarter and year-to-date decreases were due to the
completion of certain Pacesetter projects; however, Pacesetter continues to
invest in major ongoing bradycardia, tachycardia and programmer R&D projects.
PURCHASED RESEARCH AND DEVELOPMENT. The $5,000 non-cash purchased R&D charge,
representing the appraised value of in-process R&D which must be expensed under
generally accepted accounting principles for purchase accounting, related to the
acquisition of The Heart Valve Company (see Note 2 - Acquisitions).
OTHER INCOME/EXPENSE. Other income in the third quarter 1996 totalled $1,021
compared to other expense of $897 in the third quarter 1995. For the first nine
months of 1996 other income totalled $12,367 versus other expense of $5,546 in
the comparable 1995 period.
Interest expense in third quarter 1996 decreased to $358 from $2,933 in the
third quarter 1995 due to a substantial reduction in Pacesetter acquisition
related debt which was totally repaid during the third quarter 1996. On a
year-to-date basis, several non-recurring 1996 transactions increased other
income over 1995, including a gain on sale of the Company's cardiac assist
business and the successful completion of litigation related to the terminated
Electromedics' acquisition which were partially offset by transaction costs
associated with the Daig acquisition.
INCOME TAX PROVISION. The Company's 1996 effective income tax rate was 35%
compared to 31% in 1995. The increase was attributable to changes to Internal
Revenue Code (IRC) regulations which were finalized in the second quarter 1996
and which were retroactive to the beginning of 1996, as well as to
non-deductible expenses associated with the Daig acquisition and to separate
previously legislated changes relating to taxation of Puerto Rican related
income. The IRC regulation changes significantly reduce tax benefits derived
from the Company's Puerto Rican operations.
OUTLOOK. As provided for under the Private Securities Litigation Reform Act of
1995, the Company cautions investors that a number of factors could cause actual
future results of operations to vary from those anticipated in previously made
forward-looking statements and any other forward-looking statements made in this
document and elsewhere by or on behalf of the Company. Net sales could be
materially affected by legislative or administrative reforms to the U.S.
Medicare and Medicaid systems in a manner that would significantly reduce
reimbursement for procedures using the Company's medical devices, the
acquisition of key patents by competitors that would have the effect of
excluding the Company from new market segments, health care industry
consolidation resulting in customer demands for price concessions, products
introduced by competitors with advanced technology and better features and
benefits or lower prices, and fewer procedures performed in a cost conscious
environment. Cost of sales could be materially affected by unfavorable
developments in the area of products liability and price increases from the
Company's suppliers of critical components. Operations could be affected by the
Company's ability to execute its diversification strategy or to integrate
acquired companies, a serious earthquake affecting the Company's Pacesetter
facility in Los Angeles California and attempts by competitors to gain market
share through aggressive marketing programs. In addition, the elimination of
Internal Revenue Code Section 936 will result in the Company's effective income
tax rate increasing over time. The Company expects to incur significant charges
in connection with its acquisitions of Ventritex and Teletronics.
FINANCIAL CONDITION:
The Company's financial condition at September 30, 1996, continues to be strong.
Long-term debt was fully repaid during the third quarter. In addition, the
Company had $165,922 of cash and marketable securities. The ratio of current
assets to current liabilities was 2.8 to 1 at September 30, 1996.
Total assets decreased $7,916 during the third quarter 1996. Cash and marketable
securities decreased $32,376 because cash flow from operations and cash on hand
were used to reduce debt and to acquire the business of Biocor(R) Industria E
Pesquisas Ltd. Accounts receivable decreased $4,987 principally due to third
quarter net sales that were lower than the second quarter. Inventories increased
$391. Net property, plant and equipment increased $16,980 primarily as a result
of capital investments in pacemaker manufacturing facilities and information
systems.
Shareholders' equity increased $38,507 during the quarter to $867,288. The
increase resulted from net income of $36,295, the exercise of stock options of
$2,630 and a foreign currency translation adjustment of $1,315 which were
partially offset by a net unrealized loss on investments of $1,733.
PART II OTHER INFORMATION
Item 1. LEGAL PROCEEDINGS
From 1987 to 1991, Siemens AG through its Pacesetter and other
affiliates ("Siemens") manufactured and sold approximately 32,000
model 1016T and 1026T pacemaker leads of which approximately 25,000
were sold in the U.S. In March 1993 Siemens was sued in federal court
in Cincinnati, Ohio ("the Wilson case"). The suit alleged that the
model 1016T leads were negligently designed and manufactured. Class
action status was granted by the court in September 1993.
When St. Jude acquired from Siemens substantially all of its worldwide
cardiac rhythm management business ("Pacesetter") on September 30,
1994, the purchase agreement specifically provided that Siemens retain
all liability for the Wilson case, as well as all other litigation
that was pending or threatened before October 1, 1994. The purchase
agreement also provided that St. Jude would assume liability for other
products liability claims which arose after September 30, 1994.
Siemens and St. Jude were named defendants in a class action suit
filed in March 1995 in Houston, Texas for alleged defects in models
1016T and 1026T pacemaker leads (the "Hann case"). The suit sought
class action status for patients who had inner insulation failures of
these leads after March 22, 1993 and who were not members of the
Wilson class. Siemens and St. Jude settled the Wilson and Hann cases
in November 1995. Management currently estimates the Company's share
of the settlement to be approximately $5 million; however, the precise
number of class members, and the corresponding financial liability,
could increase or decrease as the process for filing claims is
completed. The settlement agreement has an "opt out" provision for
class members. Apart from this class action settlement, additional
claims could be made or lawsuits brought by patients with these leads
whose leads fail at a later date or whose leads fail for reasons
outside the class definition.
St. Jude's products liability insurance carrier, Steadfast, a wholly
owned subsidiary of Zurich Insurance Company ("Zurich"), has denied
coverage for this case and has filed suit against St. Jude in federal
district court in Minneapolis seeking rescission of the policy
covering Pacesetter business retroactive to the date St. Jude acquired
Pacesetter. Zurich alleges that St. Jude made material negligent
misrepresentations to Zurich including failure to disclose the Wilson
case in order to procure the insurance policy. St. Jude has filed an
answer denying Zurich's claim and has alleged that Zurich specifically
had knowledge of the Wilson case.
The terms of the products liability insurance policy which Zurich is
seeking to rescind provide that St. Jude would be entitled to $10
million in coverage for the 1016T and 1026T pacemaker lead claims
after payment by St. Jude of a self insured retention. St. Jude is
investigating whether it may have claims against any entities, in
addition to Zurich, arising from this situation, and has brought suit
against its former insurance broker, Johnson & Higgins.
The Company is unaware of any other pending legal proceeding which it
regards as likely to have a material adverse effect on its business.
Item 6. EXHIBITS and REPORTS ON FORM 8-K
(a) Exhibits
Exhibit
Number Exhibit
------ -------
2 Not applicable
4 Amended and Restated Rights Agreement
dated as of June 26, 1990 between the
Company and Norwest Bank Minneapolis,
N.A., as Rights Agent including the
Certificate of Designation, Preferences
and Rights of Series A Junior
Participating Preferred Stock is
incorporated by reference to Exhibit 1
of the Registrant's Form 8 Amendment 2
to Form 8-A dated July 6, 1990.
10 Not applicable
22 Not applicable
23 Not applicable
24 Not applicable
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed in its behalf by the
undersigned thereunto duly authorized.
ST. JUDE MEDICAL, INC.
November 8, 1996 /s /STEPHEN L. WILSON
- --------------------- -------------------------------------
DATE STEPHEN L. WILSON
Vice President - Finance
and Chief Financial Officer
(Principal Financial and
Accounting Officer)