SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange
Act of 1934
Date of Report: February 26, 1997
PLC SYSTEMS INC.
----------------
(Exact Name of Registrant as Specified in Charter)
British Columbia, Canada 0-19561 04-3153858
------------------------ ------- ----------
(State or Other Jurisdiction (Commission (I.R.S. Employer
of Incorporation) File Number) Identification Number)
10 Forge Park, Franklin, Massachusetts 02038
--------------------------------------------
(Address of Principal Executive Offices) (Zip Code)
(508) 541-8800
--------------
(Registrant's Telephone Number, Including Area Code)
TABLE OF CONTENTS
FORM 8-K
February 26, 1997
Item Page
---- ----
Item 5. Other Events 1
Item 7. Exhibits 1
Signature 2
i
ITEM 5. OTHER EVENTS.
The press release of the Registrant dated February 26, 1997, a copy of
which is annexed hereto as Exhibit Number 99a, is incorporated by reference
herein. The press release describes the notification from the Food and Drug
Administration ("FDA") to the Registrant that the Registrant's application for
its proprietary 1000 watt, carbon dioxide (CO2) Heart Laser(TM) has been filed
with the FDA.
The press release of the Registrant dated February 27, 1997, a copy of
which is annexed hereto as Exhibit Number 99b, is incorporated by reference
herein. The press release contains the Registrant's financial results for the
fourth quarter and year ended December 31, 1996.
ITEM 7. EXHIBITS
The following exhibits are filed herewith:
Exhibit
No. Title
--- -----
99a Press Release of the Registrant dated February 26, 1997.
99b Press Release of the Registrant dated February 27, 1997.
1
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 hereunto duly authorized.
PLC SYSTEMS INC.
By: /s/ Patricia L. Murphy
--------------------------
Patricia L. Murphy
Chief Financial Officer
Date: March 5, 1997
2
EXHIBIT INDEX
Exhibit
No. Title
--- -----
99a Press Release of the Registrant dated February 26, 1997.
99b Press Release of the Registrant dated February 27, 1997.
3
NEWS RELEASE PLC
MEDICAL
SYSTEMS, INC.
FOR IMMEDIATE RELEASE:
CONTACTS: MICHELE FASANO
DIRECTOR OF CORPORATE COMMUNICATIONS
800-211-7327
FOOD AND DRUG ADMINISTRATION FILES PLC SYSTEMS'
PREMARKET APPROVAL APPLICATION
FOR THE HEART LASERTM
- A MILESTONE ACHIEVEMENT IN THE FDA REVIEW PROCESS -
FRANKLIN, MA, FEBRUARY 26, 1997 -- PLC SYSTEMS INC. (AMEX SYMBOL: PLC) today
announced that the Company's expedited PreMarket Approval (PMA) application for
its proprietary 1000 watt CO2 Heart Laser has been filed by the Food and Drug
Administration (FDA). The filing of this expedited PMA application indicates
that the FDA is prepared to prioritize and commit its resources to this
application through the remaining review process
M. Lee Hibbs, President and CEO of PLC Systems Inc., stated, "The filing of our
application is a major milestone achievement in the FDA review process. The fact
that expedited review has been granted should intensify the FDA'a activity and
may compress the remaining process time." Mr. Hibbs continued, "After seven
years of development and clinical testing of The Heart LaserTM in the treatment
of coronary artery disease, PLC Systems has entered what we believe is the final
stage of a definitive process toward FDA approval. We believe the recent filing
of the PMA application for the Company's CO2 Heart Laser allows PLC Systems to
remain on track for an FDA approval this year, establishing a long, solid U.S.
lead time for The Heart LaserTM over any competing technologies."
Mr. Hibbs concluded, "The clinical results of TMR using The Heart LaserTM in
late stage coronary artery disease patients have been published in major
cardiovascular journals worldwide as well as presented at several scientific
meetings. The results have demonstrated statistically significant reductions in
chest pain, increases in myocardial perfusion and improvements in patient
quality of life. We believe The Heart LaserTM has the potential to be a leading
device in the treatment of heart disease. It is the Company's expectations that
TMR using The Heart LaserTM will be rapidly accepted as a standard of care for
end-stage coronary artery disease patients as well as evaluated and used as an
adjunct to the approximate 675,000 cardiac bypass surgeries performed
worldwide."
- OVER -
PLC SYSTEMS INC. is a cardiac revascularization company whose mission is to be
the global leader in Transmyocardial Revascularization (TMR) by pioneering,
developing and supplying TMR systems and their components. TMR has the potential
to provide patients suffering from coronary artery disease a third alternative
or adjunct to angioplasty and cardiac bypass surgery. PLC Medical Systems, Inc.,
a wholly owned subsidiary of PLC Systems Inc., has developed the CO2 Heart Laser
which employs the Company's patented heart-synchronized pulsed laser system
technology for TMR. PLC Systems has been granted expedited review of its
PreMarket Approval (PMA) application for TMR using The Heart LaserTM to treat
cardiac patients with medically refractory angina who are not candidates for
angioplasty or bypass surgery.
# # #
Note: Certain of the above statements may be forward-looking statements that
involve risks and uncertainties. In such instances, actual results could differ
materially as a result of a variety of factors including competitive
developments, no guarantee of FDA approval and other risk factors listed from
time to time in the Company's SEC reports.
NEWS RELEASE PLC
MEDICAL
SYSTEMS, INC.
FOR IMMEDIATE RELEASE
CONTACT: MICHELE FASANO
DIRECTOR OF CORPORATE COMMUNICATIONS
800-211-7327
PLC SYSTEMS REPORTS FOURTH QUARTER
AND YEAR END FINANCIAL RESULTS
- COMPANY SHIPS 31 HEART LASERS IN 1996, UP 35% OVER LAST YEAR -
- THE FDA FILES THE PMA APPLICATIONS FOR THE HEART LASERTM -
FRANKLIN, MA, FEBRUARY 27, 1997 -- PLC SYSTEMS INC. (AMEX SYMBOL: PLC) today
announced financial results for the fourth quarter and year ended December 31,
1996.
Total revenues for the fourth quarter ended December 31, 1996 were $3,120,000 as
compared to revenues of $7,399,000 for the corresponding quarter in 1995. The
net loss for the fourth quarter ended December 31, 1996 was $1,351,000, or $0.08
per share, compared to net income of $3,208,000 or $0.19 per share for the
fourth quarter of 1995.
Total revenues for the year ended December 31, 1996 were $11,872,000, compared
to revenues of $13,345,000 for the year ended December 31, 1995. The net loss
for the year ended December 31, 1996 was $1,540,000, or $0.09 per share,
compared to net income of $2,004,000, or $0.12 per share for the year ended
December 31, 1995.
The Company shipped a record 13 Heart Lasers in the fourth quarter ended
December 31, 1996. Of these shipments, nine were placements and four were sales.
For the full year 1996 the Company shipped 31 Heart Lasers, of which 17 were
placements and 13 were sales (one Heart Laser was shipped for research testing
only). This compares to 23 Heart Laser shipments for the full year 1995, of
which nine were placements and 14 were sales.
"We are pleased to report that the Company reached its goal of shipping 30 Heart
Lasers in 1996," stated M. Lee Hibbs, President and CEO of PLC Systems Inc. "The
13 Heart Laser shipments in the fourth quarter of 1996 is a record best for PLC
Systems. The majority of Heart Laser shipments were placement contracts, and we
believe this will benefit the Company over time. In fact, the placement/service
fees in 1996 doubled the fees collected in the prior year." Mr. Hibbs continued,
"More importantly, the Food and Drug Administration has notified the Company
that its PMA application for The Heart LaserTM has been officially filed at the
Agency.
- MORE -
PLC Systems Inc.
Fourth Quarter/Year End Earnings
Page 2
We are very excited about the filing of the Company's PMA by the FDA. It is an
important step toward full approval and is necessary before an advisory panel
meeting can be scheduled. TMR has been granted expedited review by the FDA and
therefore, The Heart Laser PMA application is given priority in review at the
Agency. We have high hopes that the PMA application will progress rapidly
through the final stages of approval."
PLC Systems has implemented both a placement strategy and a direct/distributor
sales strategy for Heart Laser purchases. The placement program allows the
Company to receive recurring revenues based on usage of The Heart Laser rather
than one-time revenues for the sale of each Heart Laser. Under the placement
model, an installation fee of up to $25,000 is recorded when The Heart Laser TMR
system is installed and the Company then receives a fee per contractual
agreements.
Commenting on the Company's financial results, Patricia Murphy, Chief Financial
Officer of PLC Systems Inc., stated, "Nineteen ninety-six is the first year in
the Company's history in which the number of Heart Lasers shipped under the
placement model exceeded the number of lasers sold. In 1996, 17 Heart Lasers
were shipped under the placement model (nine in the fourth quarter) and 13
lasers were shipped as sales. In the prior year, the Company shipped 23 Heart
Lasers but the majority of those shipments were sales. Included in the 1995
sales were six fourth quarter shipments to the Company's exclusive distributor
in Japan, a contract valued at over $5 million. PLC Systems is pleased to have
achieved roughly the same revenue as last year without any similar agreements.
In addition, the Company made the transition to a higher level of placement
contracts versus sales. PLC Systems will continue to emphasize shipments under
the placement contract as we believe this will benefit the Company long term by
providing more revenue over an extended period of time."
Ms. Murphy continued, "As we move forward in the FDA review process, PLC Systems
has begun to prepare for the expected launch of The Heart Laser. Selling,
general and administrative expenses increased significantly over last year as
the Company established three new international subsidiaries in the fourth
quarter and increased its sales, marketing and clinical service presence both
domestically and abroad. Additionally, PLC moved to a new 37,000 square foot
facility, increased staffing in all departments and expanded its presence at the
various medical/scientific meetings." She continued, "Research and development
costs increased as PLC Systems began the development of a second generation
Heart Laser and its fiber based percutaneous TMR program. We have also
undertaken additional clinical studies (i.e., TMR in combination with cardiac
bypass surgery). These new projects are important in building upon the potential
markets for TMR. Management estimates the initial U.S. market for TMR using The
Heart Laser to be approximately 150,000 patients and growing. Yet, we believe
the greatest market potential for TMR with The Heart Laser is as an adjunct
therapy to the approximate 675,000 bypass surgeries performed each year
worldwide."
Updating investors on the progress of TMR using the Company's CO2 Heart Laser,
M. Lee Hibbs, President and CEO of PLC Systems Inc. stated, "To date, nearly
3,000 patients in 29 countries have received treatment with The Heart Laser. In
1996, we succeeded in doubling the number of patients treated as well as the
number of countries in which TMR is available. TMR using the Company's
proprietary CO2 Heart Laser is on the agenda of nearly every major medical
meeting worldwide and
- MORE -
PLC Systems Inc.
Fourth Quarter/Year End Earnings
Page 3
the U.S. clinical results continue to be outstanding. The annual U.S. TMR
Symposia will be sponsored this year by the Washington Heart Institute and is
scheduled for May 1997. In addition, new data will be presented at both the
American College of Cardiology and the American Association of Thoracic
Surgeons. Nineteen ninety-seven promises to be a very exciting year for PLC
Systems. We plan to introduce, for the first time, TMR using The Heart Laser
into several countries and expect to exceed the 31 shipments made in 1996."
PLC SYSTEMS INC. is a cardiac revascularization company developing medical
systems and technology with the potential to provide patients suffering from
coronary artery disease a third alternative to angioplasty and cardiac bypass
surgery. PLC Medical Systems, Inc., a wholly owned subsidiary of PLC Systems
Inc., has developed The Heart Laser which uses patented technology for a new
cardiosurgical procedure known as transmyocardial revascularization (TMR). The
Company has been granted expedited review of its premarket approval (PMA)
application for TMR using the 1000 watt CO2 Heart Laser to treat cardiac
patients with medically refractory angina who are not candidates for angioplasty
or bypass surgery.
Note: Certain of the above statements may be forward-looking statements that
involve risks and uncertainties. In such instances, actual results could differ
materially as a result of a variety of factors including competitive
developments, no guarantee of FDA approval and other risk factors listed from
time to time in the Company's SEC reports.
- MORE -
PLC Systems Inc.
Fourth Quarter/Year End Earnings
Page 4
PLC SYSTEMS INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Dollars in thousands, except per share)
<TABLE>
<CAPTION>
Three Months Ended Year Ended
December 31, December 31,
---------------------- ------------------
1996 1995 1996 1995
---- ---- ---- ----
<S> <C> <C> <C> <C>
Revenues:
Product Sales............................ $2,314 $6,886 $9,082 $11,938
Placements/Service....................... 806 513 2,790 1,407
------ ------ ------- -------
Total Revenues......................... 3,120 7,399 11,872 13,345
Cost of Revenues:
Product.................................. 976 1,703 2,911 4,177
Placements/Service....................... 416 192 1,155 386
------- ------- ------- -------
Total Cost of Revenues................. 1,392 1,895 4,066 4,563
Gross profit .............................. 1,728 5,504 7,806 8,782
Operating expenses:
Selling, general and administrative...... 2,426 1,794 7,023 5,035
Research costs........................... 791 530 2,835 2,246
------ ------- -------- -------
Total operating expenses............... 3,217 2,324 9,858 7,281
Income/(loss) from operations.............. (1,489) 3,180 (2,052) 1,501
Other Income............................... 134 113 512 588
--------- ------ -------- -------
Income/(loss) before taxes................. (1,355) 3,293 (1,540) 2,089
Provision for income taxes................. (4) 85 0 85
----------- ------- --------- -------
Net income/(loss).......................... ($1,351) $3,208 ($1,540) $2,004
======== ======= ======== ========
Net income/(loss) per share................ ($0.08) $0.19 ($0.09) $0.12
Shares used to compute
net income/(loss) per share............. 16,511,000 17,114,000 16,376,000 16,590,000
</TABLE>
BALANCE SHEET HIGHLIGHTS
<TABLE>
<CAPTION>
December 31, December 31,
1996 1995
---- ----
<S> <C> <C>
Cash and short term investments...................... $8,509 $7,204
Total current assets................................. 14,168 16,230
Total Assets......................................... 19,417 18,290
Total current liabilities............................ 2,923 2,689
Stockholders' equity................................. 16,467 15,508
</TABLE>
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