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FORM 10-Q
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
(Mark One)
[ X ] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended June 30, 2000
...........................................
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 0-23776
.................................................
HemaSure Inc.
.............................................................
(Exact name of registrant as specified in its charter)
Delaware 04-3216862
................................. ..........................
(State or other jurisdiction of incorporation (I.R.S. Employer
or organization ) Identification No.)
140 Locke Drive, Marlborough, Massachusetts 01752
.......................................................
(Address of principal executive offices)
(Zip Code)
(508) 490-9500
.......................................................
(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 (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
----- ------
Indicate the number of shares outstanding of each of the issuer's classes
of common stock, as of the latest practicable date.
Common Stock, par value $.01 per share 19,706,003
-------------------------------------- -----------------------------
Class Outstanding at August 3, 2000
293675.2
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HemaSure Inc.
INDEX
<TABLE>
<CAPTION>
Page
<S> <C>
PART I Financial Information
Item 1. Financial Statements............................................................................1
Consolidated Balance Sheets as of June 30, 2000 and December 31, 1999..............................1
Consolidated Statements of Operations for the Three and Six Month Periods Ended
June 30, 2000 and 1999.............................................................................2
Consolidated Statements of Cash Flows for the six month Periods Ended
June 30, 2000 and 1999.............................................................................3
Notes to Consolidated Financial Statements.........................................................4
Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations............6
Item 3. Quantitative and Qualitative Disclosures About Market Risk........................................9
PART II Other Information
Item 1. Legal Proceedings................................................................................9
Item 2. Changes in Securities and use of Proceeds........................................................10
Item 3. Defaults Upon Senior Securities..................................................................10
Item 4. Submission of Matters to a Vote of Security Holders..............................................11
Item 5. Other Information................................................................................11
Item 6. Exhibits and Reports on Form 8-K.................................................................11
Signatures................................................................................................S-1
</TABLE>
293675.2
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Part I - FINANCIAL INFORMATION
Item 1. Financial Statements.
HemaSure Inc.
Consolidated Balance Sheets
(Unaudited)
( In thousands ) June 30, December 31,
2000 1999
------- -----------
ASSETS
Current assets:
Cash and cash equivalents $7,535 $5,243
Marketable securities 14,846 -
Accounts receivable 228 443
Inventories 3,357 806
Deferred financing costs 213 725
Prepaid expenses 430 276
--- ---
Total current assets 26,609 7,493
Property and equipment, net 2,197 1,547
Other assets 50 50
-- --
Total assets $28,856 $9,090
======= ======
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $1,590 $1,199
Accrued expenses 1,464 1,520
Notes payable - current portion 5,032 5,030
Capital lease obligations - current portion 7 71
- --
Total current liabilities 8,093 7,820
Note payable 27 43
-- --
Total liabilities 8,120 7,863
----- -----
Stockholders' equity:
Common stock 197 158
Additional paid-in capital 112,376 86,241
Accumulated deficit (91,837) (85,172)
-------- --------
Total stockholders' equity 20,736 1,227
Total liabilities and stockholders' equity $28,856 $9,090
======== ========
The accompanying notes are an integral part of the financial statements.
293675.2
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HemaSure Inc.
Consolidated Statements of Operations
For The Three- and Six-Month Periods Ended
June 30, 2000 and 1999
( Unaudited )
(In thousands, except
per share amounts)
<TABLE>
<CAPTION>
Three-month periods Six-month periods
Ended June 30, Ended June 30,
2000 1999 2000 1999
---- ---- ---- ----
<S> <C> <C> <C> <C>
Revenues $643 $9 $2,459 $13
Costs and expenses:
Cost of products sold 1,217 448 3,401 783
Research & development 1,342 526 2,804 1,050
Legal expense related to patents 257 352 409 1,192
Selling, general and administrative 1,120 856 2,229 1,705
----- --- ----- -----
Total costs and expenses 3,936 2,182 8,843 4,730
----- ----- ----- -----
Loss from operations (3,293) (2,173) (6,384) (4,717)
Interest income 327 48 460 59
Interest expense (380) (348) (754) (733)
Other Income - - 13 -
-------- -------- ------- -------
Net loss $ (3,346) $ (2,473) $ (6,665) $ (5,391)
======== ======== ======== ========
Net loss per share - basic and
diluted $ (0.17) $ (0.17) $ (0.36) $ (0.45)
======== ======== ======== ========
Weighted average number of shares of
common stock outstanding - basic and
diluted 19,652 14,830 18,346 12,041
</TABLE>
The accompanying notes are an integral part of the financial statements.
293675.2
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HemaSure Inc.
Consolidated Statements of Cash Flows
( Unaudited )
(In thousands) Six-month periods
Ended June 30,
2000 1999
---- ----
Cash flows from operating activities:
Net loss $ (6,665) $(5,391)
Adjustments to reconcile net loss to net cash
used in operating activities
Financing costs related to warrants 512 512
Depreciation and amortization 308 228
Accretion of marketable securities discount (57) -
Provision for Inventories 480 -
Changes in operating assets and liabilities:
Accounts receivable 215 (6)
Inventories (3,031) (49)
Prepaid expenses (154) (32)
Accounts payable and accrued expenses 335 (453)
------ ------
Net cash used in operating activities (8,057) (5,191)
======= =======
Cash flows from investing activities:
Purchase of available-for-sale marketable securities (14,789) -
Additions to property and equipment (958) (111)
Increase in other assets - (8)
-------- ------
Net cash used in investing activities (15,747) (119)
-------- ------
Cash flows from financing activities:
Proceeds from issuance of common stock 26,174 10,974
Repayments of notes payable (14) 11
Repayments of capital lease obligations (64) (104)
------- ------
Net cash provided from financing activities 26,096 10,881
------- ------
Net increase in cash and cash equivalents 2,292 5,571
Cash and cash equivalents at beginning of period 5,243 1,827
------- ------
Cash and cash equivalents at end of period $ 7,535 $ 7,398
======= =======
The accompanying notes are an integral part of the financial statements.
293675.2
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HemaSure Inc.
Notes To Consolidated Financial Statements
1. Basis of Presentation
The accompanying financial statements are unaudited and have been
prepared on a basis substantially consistent with the audited financial
statements.
Certain information and footnote disclosures normally included in the
Company's annual statements have been condensed or omitted. The condensed
interim financial statements, in the opinion of management, reflect all
adjustments (including normal recurring accruals) necessary for a fair
statement of the results for the interim periods ended June 30, 2000 and
1999.
The results of operations for the interim periods are not necessarily
indicative of the results of operations to be expected for the fiscal
year. These interim financial statements should be read in conjunction
with the audited financial statements for the year ended December 31,
1999, which are contained in the Company's Form 10K (File No. 0-23776),
filed with the Securities and Exchange Commission on March 30, 2000.
2. Inventories
Inventories consist of the following:
<TABLE>
<CAPTION>
(In thousands) June 30, 2000 December 31, 1999
------------- -----------------
<S> <C> <C>
Raw materials $1,682 $393
Work in progress 1,073 401
Finished goods 602 12
------ ----
$3,357 $806
------ ----
3. Property and Equipment
Property and equipment consists of the following:
(In thousands) June 30, 2000 December 31, 1999
------------- -----------------
Property and equipment $4,051 $3,614
Less accumulated depreciation and amortization (2,632) (2,324)
------- -------
1,419 1,290
Construction in progress 778 257
------- -------
$ 2,197 $1,547
======= ======
</TABLE>
293675.2
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<PAGE>
4. Equity Financing
In March 2000, the Company completed a private placement yielding gross proceeds
of $27,975,000 in which institutional investors purchased 3,730,000 shares of
its common stock at a purchase price of $7.50 per share. The Company has
registered 2,551,320 of such shares for resale. The Company intends to use the
net proceeds of $25,960,000 from the private placement for working capital,
capital equipment and general corporate purposes.
5. Net loss per share
The net loss per share is based on the weighted average number of common stock
outstanding during the period. Common Share equivalents are not included in the
per share calculation where the effect of their inclusion would be antidilutive.
Common Share equivalents of the Company consist of common stock warrants and
stock options. The Company had 4,978,303 and 5,050,028 Common Share equivalents
at June 30, 2000 and 1999, respectively.
6. Litigation
The Company is a defendant in a lawsuit brought by Pall Corporation ("Pall")
regarding the Company's LeukoNet System, which is no longer made or sold by the
Company. In a complaint filed in November 1996, Pall alleged that the
manufacture, use and/or sale of the LeukoNet System infringed upon two patents
held by Pall. Pall dropped its allegations concerning infringement of one of the
patents and alleges only that the LeukoNet System infringed Pall's U.S. Patent
No. 4,952,572 (the "'572 Patent").
With respect to the allegations concerning the '572 Patent, the Company answered
the complaint stating that the LeukoNet System does not infringe any claim of
the asserted patents. Further, the Company counterclaimed for declaratory
judgment of invalidity, noninfringement and unenforceability of the '572 Patent.
Pall amended its complaint to add Lydall, Inc., whose subsidiary supplied the
filter media for the LeukoNet System, as a co-defendant. The Company filed for
summary judgment of non-infringement, and Pall cross-filed for summary judgement
of infringement at the same time. Lydall, Inc. supported the Company's motion
for summary judgment of non-infringement, and filed a motion for summary
judgment that the asserted claims of the '572 patent are invalid as a matter of
law. Discovery has been completed in the action. The Court held a hearing on the
summary judgment motions on April 18, 2000. No decision has been made on the
motions.
The Company and Gambro BCT filed a complaint for declaratory relief against Pall
in the United States District Court of Colorado. The Company and Gambro BCT seek
declaratory relief that the '572 Patent, Pall's U.S. Patent No. 5,451,321 (the
"'321 Patent") and Pall's U.S. Patent No.'s 5,229,012, 5,344,561, 5,501,795 and
5,863,436 are invalid and not infringed by the Company's r\LS System and methods
of using the r\LS System. Pall moved to dismiss or transfer to the Eastern
District of New York or, in the alternative, to stay this action. The Company
and Gambro BCT opposed Pall's motion. On July 16, 1999, the United States
District Court of Colorado denied Pall's motion to transfer or, in the
alternative, to stay the action, and the action is proceeding. On September 30,
1999, the Court denied Pall's motion to dismiss the action and the case is
proceeding. On October 20, 1999, Pall submitted a counterclaim alleging that the
Company's r\LS System infringes its patents that are the subject of the lawsuit
and that the Company and Gambro BCT tortiously interfered and unfairly competed
with Pall's business. The Company and Gambro BCT replied to Pall's counterclaim
and denied Pall's allegations of tortious interference, unfair competition and
patent infringement.
On July 13, 2000 Pall filed a Complaint in the United States District Court for
the District of Colorado alleging that The Company, Gambro, Inc. and Gambro AB
are infringing Pall's U.S. Patent No. 6,086,770. The Company will submit its
reply to the complaint denying the allegations of infringement.
293675.2
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On April 23, 1999, Pall filed a complaint against the Company and Gambro BCT in
the Eastern District of New York alleging that the Company's r\LS System
infringes Pall's '572 Patent and that the Company and Gambro BCT tortiously
interfered and unfairly competed with Pall's business. On May 19, 1999, Pall
amended its complaint and added Gambro Inc., Gambro A.B. and Sepracor as
defendants. The Company and Gambro BCT have moved to dismiss, transfer or stay
the action and Pall has opposed the motion. On April 18, 2000, Pall moved,
without opposition from the defendants, to dismiss the action and the Court
granted Pall's motion.
A prior lawsuit brought by Pall in February 1996 has concluded. In June 1999,
the United States Court of Appeals for the Federal Circuit determined that the
LeukoNet System did not infringe claim 39 of the '321 Patent and Pall has not
appealed that decision.
The Company has engaged patent counsel to investigate the pending litigations.
The Company believes, based upon its review of these matters, that a properly
informed court should conclude that the manufacture, use and/or sale by the
Company or its customers of the LeukoNet System and the r\LS System do not
infringe any valid enforceable claim of the Pall patents. However, there can be
no assurance that the Company will prevail in the pending litigations, and an
adverse outcome in a patent infringement action would have a material and
adverse effect on the Company's financial condition and future business and
operations, including the possibility of significant damages in the litigations
and an injunction against the sale of the r\LS System if the Company does not
prevail in the litigations.
Item 2. Management's Discussion and Analysis of
Financial Condition and Results of Operations.
Results of Operations
Overview
The Company was established in December 1993 as a wholly owned subsidiary of
Sepracor. Effective as of January 1, 1994, in exchange for 3,000,000 shares of
common stock, Sepracor transferred to the Company its technology relating to the
manufacture, use and sale of medical devices for the separation and purification
of blood, blood products and blood components and its membrane filter design
technologies.
HemaSure develops and supplies innovative blood filtration technologies designed
to help meet today's increasing demand for a safer, more reliable blood supply.
The Company's blood filtration technologies are designed to reduce
virus-carrying white blood cells (leukocytes) in donated blood to nominal levels
(a process known as "leukoreduction").
In June 1995, the Company received clearance from the United States Food and
Drug Administration (the "FDA") for the LeukoNet System, a medical device
designed for the removal of contaminating leukocytes from donated blood. Fiscal
1996 was the first full year of commercial sale of its LeukoNet System. In
February 1998, the Company determined to discontinue manufacturing the LeukoNet
System and focus on the completion of development and market introduction of its
next generation red cell filtration product, the r\LS System.
In May 1999, the Company received 510(k) clearance from the FDA to market its
r\LS System in the United States. The Company initiated sales of the r\LS System
in the United States in the third quarter of 1999.
In April 2000, the Company was notified that the American Red Cross, the
Company's largest customer, was suspending use of the r/LS System pending the
outcome of an investigation of a small number of non-critical adverse
293675.2
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<PAGE>
reactions in patients who have received a transfusion of blood filtered with the
r/LS System. See "-Liquidity and Capital Resources" below.
All of the Company's other planned blood-related products are in the research
and development stage, and certain of these products may require pre-clinical
and clinical testing prior to submission of any regulatory application for
commercial use. The Company's success will depend on the commercial acceptance
of the r\LS System and development and commercial acceptance of the other
blood-related products.
Three and six months ended June 30, 2000 and 1999
The Company recorded revenues of $643,000 for the quarter ended June 30, 2000
compared to $9,000 in the same period in 1999. Revenues were $2,459,000 for the
first six months of 2000 compared to $13,000 for the first six months of 1999.
In 1999, revenues represented a small number of leukoreduction systems sold
outside of the United States. In May 1999, the Company received 510(k) clearance
from the FDA to market its r\LS System in the United States, which accounts for
the significant increase in revenues for the three and six month periods ended
June 30, 2000. Revenues for all periods presented represent sales of the
Company's leukocyte filtration products.
Total cost of products sold exceeded total product sales in all periods due to
the high costs associated with new product manufacturing start up and low volume
production.
Research and development expenses were $1,342,000 in the second quarter of 2000
compared to $526,000 in the second quarter of 1999, and were $2,804,000 in the
six months ended June 30, 2000 compared to $1,050,000 in the six months ended
June 30, 1999. The increase in both the three and six month periods is primarily
attributable to costs associated with production capacity expansion efforts to
support then expected increased demand for the Company's r\LS System.
Legal expenses related to patents were $257,000 in the second quarter of 2000
compared to $352,000 in the second quarter of 1999, and were $409,000 in the six
months ended June 30, 2000 compared to $1,192,000 in the six months ended June
30, 1999. The expenses in both the three and six month periods are related to
costs associated with defending the Company's patent position in its outstanding
litigation with Pall Corporation. The decrease in 2000 from those expended in
1999 is due to a reduction in these costs as well as from cooperation with
Gambro BCT in connection with such costs consistent with the Company's
distribution and development agreement with Gambro.
Selling, general and administrative expenses were $1,120,000 in the three months
ended June 30, 2000 compared to $856,000 in the three months ended June 30,
1999, and were $2,229,000 in the first six months of 2000 compared to $1,705,000
in the first six months of 1999. The increase in the three and six month periods
is primarily attributable to higher sales and marketing costs associated with
the Company's increasing level of sales of its r\LS System.
Interest income for the three and six month periods ended June 30, 2000
increased compared to the three and six month periods ended June 30, 1999 due to
higher average cash and marketable securities balances available for investment.
Interest expense for the three and six month periods ended June 30, 2000
increased compared to the three and six month periods ended June 30, 1999 due to
interest related to a note payable offset, in part, by a lower average capital
lease obligation balance.
293675.2
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New Accounting Standards
In March 2000, the Financial Accounting Standard Board issued FASB
Interpretation No. 44, "Accounting for Certain Transactions Involving Stock
Compensation - an interpretation of APB Opinion No. 25" ("FIN 44"). FIN 44
clarifies the application of APB Opinion No. 25 and among other issues clarifies
the following: the definition of an employee for purposes of applying APB
Opinion No. 25; the criteria for determining whether a plan qualifies as a
noncompensatory plan; the accounting consequence of various modifications to the
terms of previously fixed stock options or awards; and the accounting for an
exchange of stock compensation awards in a business combination. FIN 44 is
effective July 1, 2000, but certain conclusions in FIN 44 cover specific events
that occurred after either December 15, 1998 or January 12, 2000. The Company
does not expect the application of FIN 44 to have a material impact on the
Company's financial position or results of operations.
In June 2000, the commission issued SAB 101B which delayed the implementation of
SAB 101 until no later than the quarter ended December 31, 2000. The Company
does not expect the application of SAB 101 to have a significant impact on its
financial position or results of operations.
Liquidity and Capital Resources
The net increase in cash and cash equivalents for the six months ended June 30,
2000 was $2,292,000. This increase is attributable primarily to net cash
provided from financing activities of $26,096,000, offset in part by net cash
used in operating activities of $8,057,000 and net cash used in investing
activities of $15,747,000.
Net cash provided from financing activities relates primarily to the net
proceeds from the issuance of common stock of $26,174,000 in the period, the
majority of which is due to the Company's March 2000 private placement. Net cash
used in operating activities is primarily attributable to the net loss of
$6,665,000, inventory of $3,031,000 and prepaid expenses of $154,000. This was
offset in part by an increase in accounts payable and accrued expense balances
of $335,000 and a decrease in accounts receivable of $215,000 and non-cash
operating charges for financing costs related to warrants of $512,000,
depreciation and amortization of $308,000 and provision for inventories of
$480,000. Net cash used in investing activities is due to purchases of
available-for-sale marketable securities of $14,789,000 and the acquisition of
property and equipment of $958,000 in the period.
In March 2000, the Company completed a private placement yielding gross proceeds
of $27,975,000 in which institutional investors purchased 3,730,000 shares of
its common stock at a purchase price of $7.50 per share. The Company has
registered 2,551,320 of such shares for resale. The Company intends to use the
net proceeds of $25,960,000 from the private placement for working capital,
capital equipment and general corporate purposes.
In April 2000, the Company was notified that the American Red Cross ("ARC"), the
Company's largest customer, was suspending use of the Company's r\LS System
pending the outcome of an investigation of a small number of non-critical
adverse reactions in patients who have received a transfusion of blood filtered
with the r\LS. There have been approximately 25 reactions reported to the
Company from about 14 patients out of approximately 150,000 units of blood
transfused utilizing the Company's r\LS product. The patients involved with
these reactions are primarily hematology or oncology patients who have received
multiple transfusions. The reaction rate is less than .02 percent, and involves
pain in the back, head or neck area. These reactions are not permanent and are
treatable using standard practices. It is uncertain at this time when and if the
American Red Cross will resume the purchase and use of the Company's filter
system. The outcome of this evaluation and the resulting decision by the
American Red Cross could materially and adversely affect the future operations
of the Company.
Due to the suspension of use announced by the ARC in April, there are
approximately 160,000 r\LS units that are either held in quarantine at the ARC
or in the Company's inventory as of June 30, 2000. Depending on the outcome of
the evaluation being conducted by the Company and the ARC related to the
reported transfusion reactions, the Company may need to repair, replace or give
the ARC credit for units in its inventory and repair or discard the r\LS units
in the Company's inventory.
293675.2
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<PAGE>
The Company believes, based on its current operating plan, that its existing
cash and marketable securities balances will be sufficient to fund the Company's
operations beyond the second quarter of 2001. If the Company's plans or
assumptions change, if the Company's assumptions prove to be inaccurate or if
the Company experiences unanticipated costs or competitive pressures, it may
seek to raise additional capital by pursuing strategic partnerships, public or
private equity and/or debt financing. If the Company fails to generate such cash
flow or obtain any such financing on terms favorable to it or if other
unforeseen circumstances occur, the Company may be unable to continue to
commercialize and market the r\LS System or complete the development of the
Company's proposed products and/or market such products successfully, or to
continue the Company's current operations as presently conducted, if at all,
beyond the second quarter of 2001. The Company's cash requirements may vary
materially from those now planned because of factors such as successful
development of products, results of product testing, approval process at the FDA
and similar foreign agencies, commercial acceptance of its products, patent
developments and the introduction of competitive products.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Not applicable.
PART II - OTHER INFORMATION
Item 1. Legal Proceedings.
The Company is a defendant in a lawsuit brought by Pall Corporation ("Pall")
regarding the Company's LeukoNet System, which is no longer made or sold by the
Company. In a complaint filed in November 1996, Pall alleged that the
manufacture, use and/or sale of the LeukoNet System infringed upon two patents
held by Pall. Pall dropped its allegations concerning infringement of one of the
patents and alleges only that the LeukoNet System infringed Pall's U.S. Patent
No. 4,952,572 (the "'572 Patent").
With respect to the allegations concerning the '572 Patent, the Company answered
the complaint stating that the LeukoNet System does not infringe any claim of
the asserted patents. Further, the Company counterclaimed for declaratory
judgment of invalidity, noninfringement and unenforceability of the '572 Patent.
Pall amended its complaint to add Lydall, Inc., whose subsidiary supplied the
filter media for the LeukoNet System, as a co-defendant. The Company filed for
summary judgment of non-infringement, and Pall cross-filed for summary judgement
of infringement at the same time. Lydall, Inc. supported the Company's motion
for summary judgment of non-infringement, and filed a motion for summary
judgment that the asserted claims of the '572 patent are invalid as a matter of
law. Discovery has been completed in the action. The Court held a hearing on the
summary judgment motions on April 18, 2000. No decision has been made on the
motions.
The Company and Gambro BCT filed a complaint for declaratory relief against Pall
in the United States District Court of Colorado. The Company and Gambro BCT seek
declaratory relief that the '572 Patent, Pall's U.S. Patent No. 5,451,321 (the
"'321 Patent") and Pall's U.S. Patent No.'s 5,229,012, 5,344,561, 5,501,795 and
5,863,436 are invalid and not infringed by the Company's r\LS System and methods
of using the r\LS System. Pall moved to dismiss or transfer to the Eastern
District of New York or, in the alternative, to stay this action. The Company
and Gambro BCT opposed Pall's motion. On July 16, 1999, the United States
District Court of Colorado denied Pall's motion to transfer or, in the
alternative, to stay the action, and the action is proceeding. On September 30,
1999, the Court denied Pall's motion to dismiss the action and the case is
proceeding. On October 20, 1999, Pall submitted a counterclaim alleging that the
Company's r\LS System infringes its patents that are the subject of the lawsuit
and that the Company and Gambro BCT tortiously interfered and unfairly competed
293675.2
9
<PAGE>
with Pall's business. The Company and Gambro BCT replied to Pall's counterclaim
and denied Pall's allegations of tortious interference, unfair competition and
patent infringement.
On July 13, 2000 Pall filed a Complaint in the United States District Court for
the District of Colorado alleging that The Company, Gambro, Inc. and Gambro AB
are infringing Pall's U.S. Patent No. 6,086,770. The Company will submit its
reply to the complaint denying the allegations of infringement.
On April 23, 1999, Pall filed a complaint against the Company and Gambro BCT in
the Eastern District of New York alleging that the Company's r\LS System
infringes Pall's '572 Patent and that the Company and Gambro BCT tortiously
interfered and unfairly competed with Pall's business. On May 19, 1999, Pall
amended its complaint and added Gambro Inc., Gambro A.B. and Sepracor as
defendants. The Company and Gambro BCT have moved to dismiss, transfer or stay
the action and Pall has opposed the motion. On April 18, 2000, Pall moved,
without opposition from the defendants, to dismiss the action and the Court
granted Pall's motion.
A prior lawsuit brought by Pall in February 1996 has concluded. In June 1999,
the United States Court of Appeals for the Federal Circuit determined that the
LeukoNet System did not infringe claim 39 of the '321 Patent and Pall has not
appealed that decision.
The Company has engaged patent counsel to investigate the pending litigations.
The Company believes, based upon its review of these matters, that a properly
informed court should conclude that the manufacture, use and/or sale by the
Company or its customers of the LeukoNet System and the r\LS System do not
infringe any valid enforceable claim of the Pall patents. However, there can be
no assurance that the Company will prevail in the pending litigations, and an
adverse outcome in a patent infringement action would have a material and
adverse effect on the Company's financial condition and future business and
operations, including the possibility of significant damages in the litigations
and an injunction against the sale of the r\LS System if the Company does not
prevail in the litigations.
Item 2. Changes in Securities and Use of Proceeds
None.
Item 3. Defaults Upon Senior Securities
None.
293675.2
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Item 4. Submission of Matters to a Vote of Security Holders
At the Company's Annual Meeting of Stockholders held on June 7, 2000, the
following proposals were adopted by the vote specified below.
Proposal For Withheld
-------- --- --------
Election of Directors
Timothy J. Barberich 15,793,144 19,580
John F. McGuire, III 15,793,144 19,580
David Perez 15,793,144 19,580
David S. Barlow 15,793,144 19,580
Justin E. Doheny 15,793,144 19,580
Edward C. Wood 15,793,144 19,580
Frank Corbin 15,793,144 19,580
Item 5. Other Information
None.
Item 6. Exhibits and Reports on Form 8-K
EXHIBIT INDEX
a) The following exhibits are filed as part of this Quarterly Report on
Form 10-Q:
Exhibit No. Description
----------- -----------
2.1(6) Heads of Agreement, dated as of January 31, 1996,
between the Company and Novo Nordisk A/S.
3.1(1) Certificate of Incorporation of the Company.
3.2(1) By-Laws of the Company.
4.1(1) Specimen Certificate for shares of Common Stock, $.01
par value, of the Company.
4.2(9) Registration Rights Agreement, dated January 23,
1997, by and among the Company and Novo Nordisk A/S
4.3(10) Registration Rights Agreement, dated as of September
15, 1998, between the Company and Sepracor.
293675.2
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<PAGE>
Exhibit No. Description
----------- -----------
4.4(11) Warrant Agreement, dated as of September 15, 1998,
between the Company and Sepracor.
4.5(11) Warrant Certificate, dated as of September 15, 1998,
between the Company and Sepracor.
4.6(13) Registration Rights Agreement, dated as of March 23,
1999, between the Company and Sepracor.
4.7(13) Warrant Agreement, dated as of March 23, 1999,
between the Company and Sepracor.
4.8(13) Warrant Certificate, dated as of March 23, 1999,
between the Company and Sepracor.
4.9(14) Stock Subscription Agreement, dated as of May 3,
1999, between the Company and COBE.
4.10(14) Stockholder's Agreement, dated as of May 3, 1999,
between the Company and COBE.
10.1(9) 1994 Stock Option Plan, as amended.
10.2(9) 1994 Director Option Plan.
10.3(1) Form of Technology Transfer and License Agreement
between the Company and Sepracor Inc.
10.4(6) Lease Agreement for 140 Locke Drive, Marlborough, MA,
dated as of November 1995, between the Company and
First Marlboro Development Trust.
10.5(4) Employment Agreement between the Company and Dr. Hans
Heiniger, dated January 10, 1994.
10.6(7) Asset Purchase Agreement dated as of May 2, 1996
between the Company, HemaPharm Inc., HemaSure A/S and
Novo Nordisk A/S.
10.7(8) Restructuring Agreement, dated January 23, 1997,
between the Company, HemaPharm Inc., HemaSure A/S and
Novo Nordisk A/S.
10.8(9) Convertible Subordinated Note Due December 31, 2001
in the amount of U.S. $11,721,989, issued by the
Company to Novo Nordisk A/S, dated January 23, 1997.
10.9(9) Amendment to the Company's 1994 Director Option Plan,
dated June 25, 1996.
10.10(9) Amendment to the Company's 1994 Director Option Plan,
effective as of May 16, 1996.
10.11(9) Amendment to the Company's 1994 Stock Option Plan,
dated June 25, 1996.
293675.2
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Exhibit No. Description
----------- -----------
10.12(9) Amendment to the Company's 1994 Stock Option Plan,
effective as of May 16, 1996.
10.13(9) Sublease Agreement, between the Company and Novo
Nordisk A/S, dated May 2, 1996, for the Premises
(Denmark), as amended.
10.14(9) Sublease Agreement between the Company and Novo
Nordisk A/S, dated May 2, 1996, for the Warehouse
(Denmark), as amended.
10.15(12) Employment Agreement between the Company and John F.
McGuire, dated April 1, 1997.
10.16(12) Settlement Agreement, dated September 1997, by and
among the Company, HemaSure AB, HemaPharm Inc.,
Pharmacia & Upjohn Inc. and Pharmacia & Upjohn AB.
10.17(10) 1995 Employee Stock Purchase Plan, as amended.
10.18(11) Revolving Credit and Security Agreement, dated as of
September 15, 1998, between the Company and Fleet
National Bank.
10.19(11) Intellectual Property Security Agreement, dated as of
September 15, 1998, between the Company and Fleet
National Bank.
10.20(11) Promissory Note, dated as of September 15, 1998, made
by the Company in favor of Fleet National Bank.
10.21(11) Amended and Restated Master Strategic Alliance
Agreement between the Company and the American Red
Cross.
10.22(14) Senior Management Retention Agreement, dated as of
December 7, 1998, between the Company and John F.
McGuire.
10.23(14) Senior Management Retention Agreement, dated as of
December 15, 1998, between the Company and James B.
Murphy.
10.24(14) Senior Management Retention Agreement, dated as of
December 22, 1998, between the Company and Peter C.
Sutcliffe.
10.25(13) Securities Purchase Agreement, dated as of March 23,
1999, between the Company and Sepracor.
10.26(14) Amended and Restated Exclusive Distribution
Agreement, dated as of May 3, 1999, between the
Company and COBE.
10.27(15) Master Purchase Agreement, dated as of July 1, 1999,
between the Company and The American National Red
Cross.
10.28(16) Manufacturing and Supply Agreement, dated as of
December 22, 1999, between the Company and Filtertek
Inc.
10.29(16) Supply and Assembly Agreement, dated as of January
31, 2000, between the Company and Command Medical
Products Inc.
293675.2
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Exhibit No. Description
----------- -----------
10.30(16) Placement Agency Agreement, dated February 3, 2000,
between the Company and Warburg Dillon Read LLC.
10.31(16) Form of Purchase Agreement, dated March 2, 2000.
10.32(16) Schedule of purchasers which purchased shares of
common stock pursuant to the Form of Purchase
Agreement set forth in 10.31.
10.33 Indemnification Agreement, dated as of July 13, 2000,
between the Company and Ahlstrom Technical
Specialties LLC.
21.1(12) Subsidiaries of the Company.
27.1 Financial Data Schedule.
----------------------------------------
(1) Incorporated herein by reference to the Company's
Registration Statement on Form S-1, as amended (File No.
33-75930).
(2) Incorporated herein by reference to the Company's Annual
Report on Form 10-K for the year ended December 31, 1994.
(3) Incorporated herein by reference to the Company's Quarterly
Report on Form 10-Q for the quarter ended March 31, 1995.
(4) Incorporated herein by reference to the Company's
Registration Statement on Form S-1, as amended (File No.
33-95540).
(5) Incorporated herein by reference to the Company's Quarterly
Report on Form 10-Q for the quarter ended September 30, 1994.
(6) Incorporated herein by reference to the Company's Annual
Report on Form 10-K for the year ended December 31, 1995.
(7) Incorporated by reference to the Company's Quarterly Report
on Form 10-Q for the quarter ended March 31, 1996.
(8) Incorporated by reference to the Company's Current Report on
Form 8-K filed with the Securities and Exchange Commission on
February 27, 1997.
(9) Incorporated by reference to the Company's Annual Report on
Form 10-K for the year ended December 31, 1996.
(10) Incorporated by reference to the Company's Quarterly Report
on Form 10-Q for the quarter ended June 30, 1998.
(11) Incorporated by reference to the Company's Quarterly Report
on Form 10-Q for the quarter ended September 30, 1998.
293675.2
14
<PAGE>
(12) Incorporated by reference to the Company's Annual Report on
Form 10-K for the year ended December 31, 1997.
(13) Incorporated by reference to the Company's Annual Report on
Form 10-K for the year ended December 31, 1998.
(14) Incorporated by reference to the Company's Quarterly Report
on Form 10-Q for the quarter ended March 31, 1999.
(15) Incorporated by reference to the Company's Quarterly Report
on Form 10-Q for the quarter ended June 30, 1999.
(16) Incorporated by reference to the Company's Annual Report on
Form 10-K for the year ended December 31, 1999.
b) Reports on Form 8-K
None.
293675.2
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<PAGE>
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.
HemaSure Inc.
Date: August 11, 2000 /s/ John F. McGuire, III
-------------------------
John F. McGuire, III
President and Chief Executive Officer
(Principal Executive Officer)
Date: August 11, 2000 /s/ James B. Murphy
-------------------------
James B. Murphy
Senior Vice President and
Chief Financial Officer
(Principal Financial Officer)
293675.2
