SPECIALIZED HEALTH PRODUCTS INTERNATIONAL INC
10KSB/A, 2000-04-25
SURGICAL & MEDICAL INSTRUMENTS & APPARATUS
Previous: NML VARIABLE ANNUITY ACCT C OF NORTHWESTERN MUT LIFE INS CO, 485BPOS, 2000-04-25
Next: GE CAPITAL MORTGAGE SERVICES INC, 8-K, 2000-04-25





                       SECURITIES AND EXCHANGE COMMISSION
                             Washington, D.C. 20549

                             ----------------------

                                 FORM 10-KSB/A
                                (Amendment No. 1)

                             Annual Report Pursuant
                          to Section 13 or 15(d) of the
                         Securities Exchange Act of 1934

                            For the fiscal year ended
                                December 31, 1999

                             Commission file number
                                     0-26694

                 SPECIALIZED HEALTH PRODUCTS INTERNATIONAL, INC.
             (Exact name of registrant as specified in its charter)


                 Delaware                             93-0945003
      (State or other jurisdiction of       (IRS Employer Identification No.)
              incorporation)

   585 West 500 South, Bountiful, Utah 84010           (801) 298-3360
   (Address of principal executive offices)     (Registrant's telephone number,
                                                     including area code)

           Securities registered pursuant to Section 12(g) of the Act:

          Title of each class         Name of each exchange on which registered
          -------------------         -----------------------------------------
     Common Stock, $.02 Par Value                     None


         Check whether the issuer (1) 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 | |

         Check if there is no  disclosure  of  delinquent  filers in response to
Item 405 of Regulation S-B is contained  herein,  and will not be contained,  to
the  best  of  registrant's   knowledge,  in  definitive  proxy  or  information
statements  incorporated  by  reference  in Part III of this Form  10-KSB or any
amendment to this Form 10-KSB. | |

         The issuer's revenues for its most recent fiscal year were $4,850,947.

         The aggregate  market value of the voting stock held by  non-affiliates
(i.e.,  does  not  include   directors,   executive   officers  or  ten  percent
stockholders  identified  in Item 11 hereof) of the issuer as of April 12,  2000
was approximately $8,029,262.


<PAGE>

Item 6. Management's Discussion and Analysis or Plan of Operation

         The  following  discussion  and  analysis  provides  information  which
management  believes is  relevant  to an  assessment  and  understanding  of the
Company's  consolidated  results of  operations  and  financial  condition.  The
discussion  should  be read  in  conjunction  with  the  consolidated  financial
statements and notes thereto.  Wherever in this discussion the term "Company" is
used,   it  should  be  understood  to  refer  to  SHPI  and  its  wholly  owned
subsidiaries,   SHP,  Safety  Syringe   Corporation,   Specialized   Cooperative
Corporation and  Iontophoretics  Corporation,  on a consolidated  basis,  except
where the context clearly indicates otherwise.

Overview

         From its inception, the Company has incurred losses from operations. As
of December 31, 1999, the Company had cumulative net losses applicable to common
shares totaling $16,063,783. To date, the Company's principal focus has been the
design,  development,  testing and evaluation of its sharps  containers,  safety
lancets,  safety needle  technologies,  intravenous flow gauge, blood collection
devices,  and other safety medical  products,  and the design and development of
various molds and production processes.

Financial Position

         The Company had  $180,425 in cash and cash  equivalents  as of December
31, 1999.  This  represented  a decrease of  $2,299,658  from December 31, 1998.
Working  capital as of December 31,  1999,  decreased to $230,138 as compared to
$2,877,205 at December 31, 1998.  These  decreases  were largely due to the fact
that during 1999 the Company  received  only $74,400 from  financing  activities
compared to receipt of $3,813,159 from financing activities during 1998.

Years Ended December 31, 1999 and 1998

         During  the year  ended  December  31,  1999,  the  Company  had  total
operating  revenues of  $4,850,947,  compared with total  operating  revenues of
$1,039,136 for the year ended December 31, 1998.  Prior to 1999, the Company had
$3,750,000 in deferred royalty revenue  relating to the BDIT License  Agreement.
In June 1999,  BDIT and the Company  amended  the BDIT  License  Agreement.  The
amendment  provides that the $3,750,000  previously  paid by BDIT to the Company
will not be credited  against future earned  royalties and the Company will have
no  further  obligation  of any kind to BDIT  with  respect  to these  payments.
Accordingly,  the  $3,750,000  of deferred  royalty  revenue was  recognized  as
revenue during 1999. During 1999, the Company also had $1,100,947 in development
fee revenues from JJM under the JJM Agreement.  Costs incurred to generate these
development  fees  totaled  $890,222.  During  1998,  $10,202  of the  Company's
revenues were from product sales of the Company's sharps container  products and
the remaining  $1,028,934  were  development fee revenues from JJM under the JJM
Agreement.  Costs incurred to generate these  development fees totaled $823,146.
As discussed  below, the Company will look to several other products and devices
for future sales revenues.

         In November 1999, the Company and Kendall Healthcare  Products Company,
a division of Tyco  Healthcare  Group LP ("Kendall")  entered into a Development
and License Agreement (the "Kendall  Agreement")  relating to one application of
the Company's  needle  technology in the  production of a line of safety medical
needle  products,  including  six syringe  products and five other safety needle
products.  The  effective  date of the Kendall  Agreement was subject to certain
approvals  that were obtained on March 29, 2000. On April 12, 2000,  the Company
received a $1,500,000  payment less $35,044  representing the Company's share of
certain  patent  filing  costs.  The  Company  will also  receive an  additional
$1,000,000  upon the sale of  commercial  quantities of products in exchange for
the Company assigning to Kendall the FlexLoc(R) and ReLoc(TM) trademarks and two
related patents.  The assignment of the patent rights to Kendall is subject to a
preexisting  license agreement and the retention by the Company of an exclusive,
royalty free  worldwide  license in a number of  strategic  product  areas.  The
Kendall Agreement also provides for the

                                       2
<PAGE>

Company to receive development fees and ongoing royalties,  including a $500,000
advance royalty payment upon the sale of commercial  quantities of products.  It
is anticipated  that Kendall will  manufacture  all products that are subject to
the Kendall Agreement.  There can be no assurance that products will be launched
as  anticipated  or that the Company  will  realize  revenues  under the Kendall
Agreement.

         In December  1997,  the Company  entered into the JJM  Agreement  under
which the parties are seeking to  commercialize  two  applications of the safety
needle technology. The JJM Agreement provides that the Company and JJM will seek
to commercialize  two products using safety medical needle  technology.  The JJM
Agreement  provides for monthly  development  payments by JJM,  sharing of field
related patent costs,  the  possibility  of payments for initial  periods of low
volume  manufacturing,  an ongoing royalty stream and a JJM investment in molds,
assembly equipment and other capital costs related to  commercialization of each
product.  The JJM  Agreement  also  provides  for an ongoing  joint  cooperative
program  between the Company and JJM which derives future funding  directly from
sales of Company created products,  the possibility of low volume  manufacturing
revenue for the  Company and an ongoing  royalty  stream for  additional  safety
products which are jointly  approved for  development.  The Company  anticipates
that JJM will  perform  substantially  all of the  manufacturing  under  the JJM
Agreement  during  2000.  The Company  and JJM also  entered  into  arrangements
whereby they are pursuing  development and  commercialization of four additional
products.  The Company  anticipates  that the sale of one product  under the JJM
Agreement  will begin in the year 2000 with  additional  products  scheduled for
introduction  into the market in 2001.  There is no  assurance  that the Company
will realize revenues under the JJM Agreement or that any of these products will
be  launched  as  anticipated.  All  product  introductions  are  scheduled  and
controlled by JJM.

         In May  1997,  the  Company  entered  into the BDIT  License  Agreement
relating to a single  application  of the Company's  ExtreSafe(R)  safety needle
technology.  BDIT  previously told the Company that it expected to begin selling
the product that is the subject of the BDIT License  Agreement at various times.
BDIT has indicated  that it is unsure if or when product will be introduced  and
sold in the market under the BDIT License  Agreement.  BDIT has not provided the
Company with information regarding the market introduction of the product.

         The Company has an ongoing  program for  developing  products using its
fourteen medical needle  technologies and expects to develop  additional  safety
medical needle technologies.

         License and distribution  arrangements,  such as those discussed above,
create  certain  risks for the  Company,  including  (i)  reliance  for sales of
products  on  other  parties,  and  therefore  reliance  on the  other  parties'
marketing ability, marketing plans and credit-worthiness;  (ii) if the Company's
products are marketed under other parties' labels,  goodwill associated with use
of the  products may inure to the benefit of the other  parties  rather than the
Company;  (iii) the Company may have only  limited  protection  from  changes in
manufacturing  costs and raw materials costs; and (iv) if the Company is reliant
on other parties for all or  substantially  all of its sales, the Company may be
limited in its ability to negotiate with such other parties upon any renewals of
their agreements.  Further,  because such arrangements are generally expected to
provide the Company's  marketing  partners with certain  elements of exclusivity
with respect to the  products to be marketed by those  partners,  the  Company's
success will be highly dependent on the results obtained by its partners.

         Research and  development  ("R&D")  expenses were $780,425 for the year
ended December 31, 1999,  compared with $909,048 for the year ended December 31,
1998.  The  Company's  efforts  during 1999  focused on  development  of several
additional products utilizing the Company's medical safety needle  technologies.
The Company's  efforts during 1998 focused on development of several  additional
products utilizing the ExtreSafe(R) and FlexLoc(R) safety needle technology, the
safety single lancet  technology  and continued  development  work on a filmless
digitized imaging  technology (which was performed by QIC, but was funded by the
Company).  The 1998 R&D effort was expanded  beyond  development of ExtreSafe(R)
products to manually  actuated safety  sheathing  devices.  The decreases in R&D
expenses resulted  primarily from (i) a reduction in the development  activities
with respect to the filmless digitized imaging technology,

                                       3
<PAGE>

(ii) the termination of two development employees,  and (iii) a reduction in the
use of outside consultants for development activities.

         Selling,  general and  administrative  expenses were $2,776,669 for the
year ended December 31, 1999, compared to $2,946,722 for the year ended December
31,  1998.  The  decrease  resulted  mainly from (i) the officers of the Company
taking  a  combined   thirty-three  percent  reduction  in  compensation,   (ii)
downsizing  which resulted in the termination of two  administrative  employees,
and (iii) reduction in financial advisory fees.

         The Company  wrote off $105,762 in  operating  assets in 1999 that were
comprised  primarily of the write down of certain  automation  equipment and the
write off of certain obsolete computer  equipment  abandoned or sold for nominal
amounts.  In 1998, the Company wrote off $754,803 in operating  assets that were
comprised primarily of molds,  production equipment and other assets relating to
the ExtreSafe(R)  Lancet Strip. These assets were written-off in connection with
the Company's  decision to abandon the further  manufacture and  distribution of
the ExtreSafe(R) Lancet Strip.

         Net other  income was  $61,362  for the year ended  December  31,  1999
compared with $205,064 for the year ended December 31, 1998. The decrease in net
other  income is  attributable  to interest  earned on lower  levels of funds on
deposit and short-term  interest  bearing  investments.  As funds on deposit and
interest  bearing  short-term  investments  have decreased,  so has the interest
income.

Liquidity and Capital Resources

         To date,  the Company has financed its operations  principally  through
private placements of equity securities,  advanced  royalties,  development fees
and proceeds from the exercise of common stock  options.  The Company  generated
$16,200,285 and $74,400 in net proceeds through private placements of equity and
exercise of common stock options from inception through December 31, 1999 and in
1999,  respectively.  The  Company  used net cash for  operating  activities  of
$2,340,118 during the year ended December 31, 1999. As of December 31, 1999, the
Company's  liabilities  totaled $125,675.  The Company had working capital as of
December 31, 1999 of $230,138.

         The Company's  working capital and other capital  requirements  for the
foreseeable future will vary based upon a number of factors, including the costs
to complete development and bring the safety medical needle technologies,  blood
collection devices and other products to commercial viability,  and the level of
sales of the new phlebotomy product due to launch in the fourth quarter of 2000.
At  December  31,  1999,  the Company  had not  committed  to spend any funds on
capital  expenditures.  The Company believes that existing funds,  including the
$1,500,000  received from Kendall,  development  fees from JJM and Kendall under
the  respective   agreements,   license   revenues  and  funds   generated  from
commencement of product royalties under current  agreements,  will be sufficient
to maintain operations through December 31, 2000. The Company has no contractual
arrangements  that guarantee that the Company will have adequate  funding during
2000 and there can be no assurance that additional  funding,  if needed, will be
available on  commercially  reasonable  terms or at all. Any inability to obtain
additional funding if needed will have a material adverse effect on the Company,
including possibly  requiring the Company to significantly  curtail or cease its
operations.

         From time to time the Company is presented  with new  opportunities  to
design,  develop,  acquire or manufacture  safety medical devices.  In the event
such opportunities arise,  management and the Board of Directors could determine
that the pursuit of such  opportunities  is in the best  interest of the Company
and its stockholders and may decide to raise additional funding through the sale
of securities.  The Company will also continue to pursue new  arrangements  with
strategic  partners  which could  generate  additional  development or licensing
fees.  There are no  contractual  arrangements  in place that would  provide for
additional  funding and there can be no assurance  that the Company will be able
to obtain additional funding if appropriate on commercially  reasonable terms or
at all.

                                       4
<PAGE>

         At April 12,  2000,  the Company had  3,609,787  Series D Warrants  and
775,000 other warrants (the "SHPI Warrants")  outstanding  which are exercisable
for the same number of shares of Common Stock of the Company at $2.00 per share.
The  Series D Warrants  expire on the  earlier of (a) two years from the date of
effectiveness of a registration statement under the Act covering the sale of the
shares of Common Stock underlying such warrants,  which period shall be extended
day-for-day for any time that a prospectus  meeting the  requirements of the Act
is not  available,  or (b) the  redemption  date if such  warrants  are redeemed
(subject to the right of the holder to exercise the  warrants  within 20 days of
notice of such  redemption).  The SHPI Warrants expire on December 31, 2002. The
exercise of all the Warrants  would result in an equity  infusion to the Company
of $8,769,574.  As of the date hereof,  all of the warrants are out of the money
and there can be no assurance that any warrants will ever be exercised.

         The Company has granted stock  options that are  currently  exercisable
for 1,964,500 shares of Common Stock at exercise prices ranging between $.39 and
$2.625 per share.  The exercise of all of such stock  options would result in an
equity  infusion  to the  Company  of  $4,054,514.  All but  18,000 of the stock
options are out of the money and there can be no assurance that any of the stock
options will be exercised.

         In June 1998, the Company entered into an Option to Purchase  Agreement
(the "Option Agreement") with the University of Texas System to purchase certain
patents and related  technology,  research and  development for a total purchase
price of  $2,400,000.  In  accordance  with the  Option  Agreement,  a  $240,000
non-refundable  payment was made in July 1998 with the balance of  $2,160,000 to
be paid  within 30 days of the  exercise  of the  purchase  option.  The Company
retained the exclusive  right to exercise the option and acquire the patents and
related  technology  for a period of one year from the date of the  execution of
the Option Agreement or within 14 days of notification of successful  completion
of animal toxicity studies. The Company received notice of successful completion
of the  toxicity  studies in February  1999 and  subsequently  entered into four
amendments  to the Option  Agreement  resulting  in  extensions  of the exercise
period through May 2000. The Company paid a total of $265,000 in extension fees.
The Company was reimbursed for the majority of these fees from a third party who
expressed an interest in acquiring the technology from the Company upon exercise
of the option.  Subsequent to December 31, 1999, the third party determined that
it would not complete the  acquisition.  As the Company was not in a position to
exercise  the  option,  the option was allowed to expire  effective  January 23,
2000.  The Company has no  obligation  to make  additional  cash payments to the
University of Texas System.

Inflation

         The Company does not expect the impact of inflation on operations to be
significant.

Year 2000

         The  Company had  developed  plans to address  the  possible  exposures
related to the impact on its computer  systems of the Year 2000.  Since entering
the Year 2000,  the Company has not  experienced  any major  disruptions  to its
business  nor is it  aware  of any  significant  Year  2000-related  disruptions
impacting  its  customers  and  suppliers.  Furthermore,  the  Company  did  not
experience  any  material  impact on business at calendar  year end. The Company
will continue to monitor its critical  systems over the next several  months but
does not anticipate any significant  impacts due to Year 2000 exposures from its
internal systems as well as from the activities of its suppliers and customers.

Forward-Looking Statements

         When used in this Form 10-KSB,  in filings by the Company with the SEC,
in the Company's  press releases or other public or stockholder  communications,
or in oral statements made with the approval of an authorized  executive officer
of the Company,  the words or phrases  "would be," "will  allow,"  "intends to,"
"will likely  result,"  "are expected to," "will  continue,"  "is  anticipated,"
"estimate,"   "project,"  or  similar   expressions  are  intended  to  identify
"forward-looking  statements"  within  the  meaning  of the  Private  Securities
Litigation Reform Act of 1995.  Forward-looking statements specifically include,
but are not

                                       5
<PAGE>

limited to, the dates disclosed  herein upon which sales of or royalty  payments
from the Company's various products are anticipated to commence.

         The  Company  cautions  readers  not to  place  undue  reliance  on any
forward-looking  statements,  which speak only as of the date made, are based on
certain  assumptions and expectations  which may or may not be valid or actually
occur,  and which  involve  various risks and  uncertainties,  including but not
limited to risk of  product  demand,  market  acceptance,  economic  conditions,
competitive   products  and  pricing,   difficulties  in  product   development,
commercialization,   and  technology,   changes  in  the  regulation  of  safety
healthcare  products,  the  level of  marketing,  development  and  distribution
efforts of the Company's  partners and other risks.  Furthermore,  manufacturing
delays may result from  additional  mold redesigns or delays may result from the
failure to timely  obtain FDA  approval to sell future  products.  In  addition,
sales  and other  revenues  may not  commence  as  anticipated  due to delays or
otherwise.  If and when product sales  commence,  sales may not reach the levels
anticipated.  As a result, the Company's actual results for future periods could
differ materially from those anticipated or projected.

         Unless  otherwise  required by  applicable  law,  the Company  does not
undertake,   and   specifically   disclaims  any   obligation,   to  update  any
forward-looking statements to reflect occurrences,  developments,  unanticipated
events or circumstances after the date of such statement.

Risk Factors

         In  addition  to the risks set forth  above,  the Company is subject to
certain other risk factors due to its development stage status,  the industry in
which it competes and the nature of its  operations.  These risk factors include
the following.

         History  of  Losses/Profitability  Uncertain.  The  Company  is in  the
development  stage and,  except for 1999,  has  reported  losses each year since
1993. At December 31, 1999, it had an accumulated  deficit of  $16,063,783.  The
Company's  products  are  in  various  stages  of  production,   pre-production,
development and research.  The Company has made only limited sales of its sharps
container products, the only product it was selling as of December 31, 1999. The
Company does not have  marketing or  distribution  agreements  in place for this
product.  There is no assurance that the Company's products will be commercially
viable and no assurance can be given that the Company will become profitable. In
addition,  prospects  for  the  Company's  profitability  will  be  affected  by
expenses,  operational  difficulties and other factors frequently encountered in
the development of a business enterprise in a competitive  environment,  many of
which factors may be unforeseen and beyond the Company's control.

         Need for Additional  Funds. Due to the development  stage status of the
Company and the uncertainty of future profits,  the Report of Independent Public
Accountants  relating to the Company's 1999 consolidated  financial  statements,
attached  hereto,   contains  a  "going  concern"  explanatory  paragraph.   See
Consolidated  Financial  Statements and related Notes. The Company believes that
existing funds, including the $1,500,000 received from Kendall, development fees
from JJM and Kendall under the respective agreements, license revenues and funds
generated from commencement of product royalties under current agreements,  will
be sufficient to maintain  operations through December 31, 2000. The Company has
no contractual  arrangements  that guarantee that the Company will have adequate
funding during 2000 and there can be no assurance that  additional  funding,  if
needed,  will be  available  on  commercially  reasonable  terms or at all.  Any
inability to obtain additional  funding when needed will have a material adverse
effect on the Company, including possibly requiring the Company to significantly
curtail or cease its operations.

         Negative Pricing Pressures on the Company's Safety Products. Prices for
the  Company's  safety  products may be higher than for  competing  conventional
products which are not designed to provide the safety protection afforded by the
Company's  products.   The  Company's  prices,   however,  are  expected  to  be
competitive with those of competing safety  products.  Continuing  pressure from
third-party  payers  to  reduce  costs  in the  healthcare  industry  as well as
increasing  competition  from safety  products  made by other  companies,  could
adversely  affect the Company's  selling  prices.  Reductions in selling  prices
could  adversely  affect  operating   margins  if  the  Company  cannot  achieve
corresponding reductions in manufacturing costs.

                                       6
<PAGE>

         Rapidly  Changing  Technology.  The  Company  is in  various  stages of
production, pre-production,  development and research with respect to its sharps
containers, safety lancets, medical safety needle technologies, blood collection
devices and other products.  There is no assurance that  development of superior
products by competitors or changes in technology will not eliminate the need for
the Company's  products.  The introduction of competing products using different
technology could adversely  affect the Company's  attempts to develop and market
its products.

         Potential  Lack  of  Market  Acceptance.  The  use  of  safety  medical
products,  including the Company's  products,  is relatively  new. The Company's
products may not be accepted by the market and their  acceptance  will depend in
large part on (i) the  Company's  ability  (directly  or through  its  marketing
partners) to demonstrate  the  operational  advantages,  safety,  efficacy,  and
cost-effectiveness  of its products in comparison  with  competing  products and
(ii) its ability to  distribute  its products  through  major  medical  products
companies.  There can be no assurance  that the Company's  products will achieve
market  acceptance  or that  major  medical  products  companies  will  sell the
Company's products.

         Dependence on Continued  Research and  Development.  The safety medical
needle  technologies,  intravenous  flow gauge and safety  lancets  are still in
various  stages  of  development.  The  Company  is  also  exploring  additional
applications for all of its products.  The continued development of its products
and development of additional  applications and new products is important to the
long-term  success  of  the  Company.  There  can  be  no  assurance  that  such
applications  or products will be developed or, if developed,  that they will be
successful.

         Dependence on Patents and  Proprietary  Rights.  The  Company's  future
success depends in part on its ability to protect its intellectual  property and
maintain the  proprietary  nature of its  technology  through a  combination  of
patents and other intellectual property arrangements.  There can be no assurance
that the  protection  provided by patents,  if issued,  will be broad  enough to
prevent  competitors from introducing  similar products or that such patents, if
challenged,   will  be  upheld  by  the  courts  of  any  jurisdiction.   Patent
infringement  litigation,  either to enforce the Company's patents or defend the
Company from  infringement  suits,  would be expensive and, if it occurs,  could
divert Company  resources  from other planned uses. Any adverse  outcome in such
litigation  could  have  a  material  adverse  effect  on  the  Company.  Patent
applications  filed in  foreign  countries  and  patents in such  countries  are
subject to laws and  procedures  that  differ  from those in the United  States.
Patent  protection  in such  countries may be different  from patent  protection
under U.S. laws and may not be as favorable to the Company.  Certain portions of
the  Company's  international  patent  prosecution  efforts  are funded by third
parties.  The failure of the funding parties to pay for the international patent
prosecution  costs would  materially  effect the Company's  ability to prosecute
these patents. The Company also attempts to protect its proprietary  information
through the use of  confidentiality  agreements  and by  limiting  access to its
facilities.  There can be no assurance  that the  Company's  program of patents,
confidentiality  agreements  and  restricted  access to its  facilities  will be
sufficient to protect the Company's proprietary technology.

         Ability to Manage Expanding Operations. The Company intends to pursue a
strategy of rapid growth although there can be no assurance that any growth will
be achieved.  The Company plans to significantly expand its product lines and to
devote substantial  resources to support  operations,  research and development,
marketing  and  administrative  functions.  There can be no  assurance  that the
Company  will  obtain  sufficient  manufacturing  capacity on  favorable  terms,
arrange for the marketing and  distribution of its products,  attract  qualified
personnel or effectively  manage  expanded  operations.  The failure to properly
manage growth could have a material adverse effect on the Company.

         Competition/Potential Inability to Compete. The Company is engaged in a
highly  competitive  business  and will  compete  directly  with firms that have
longer operating  histories,  more experience,  substantially  greater financial
resources, greater size, more substantial research and development and marketing
organizations, and established distribution channels that are better situated in
the market than the Company. The Company's competitors and potential competitors
include Baxter  International,  Inc.,  Becton  Dickinson and Company,  Johnson &
Johnson, Sage Products, Inc., Surgicutt, Inc., Miles, Inc., B. Braun, Diagnostic
Corporation,  Boehringer  Mannheim,  Inc., Kendall Healthcare  Products Company,
Terumo Medical Corporation,  Med-Design  Corporation,  Bio-Plexus,  Inc., Maxon,
Inc.,  Retractable   Technologies,   Inc.  and  Univec,  Inc.  See  "Business  -
Competition."  Such competitors may use their economic strength to influence the
market to continue to buy their existing products. These competitors may also be
potential

                                       7
<PAGE>

strategic partners with respect to various products as are, for example, Kendall
and JJM. The Company does not have an established customer base and is likely to
encounter a high degree of  competition  in developing a customer  base.  One or
more of these  competitors  could use their  resources to improve  their current
products or develop new  products  that may compete  more  effectively  with the
Company's  products.  New competitors may emerge and may develop  products which
compete with the Company's products.  No assurance can be given that the Company
will be successful in competing in this industry.

         Product Liability. The sale of medical devices entails an inherent risk
of liability in the event of product  failure or claim of harm caused by product
operation.  There can be no  assurance  that the Company  will not be subject to
such claims, that any claim will be successfully  defended or, if the Company is
found  liable,  that the claim  will not  exceed  the  limits  of the  Company's
insurance.  The  Company's  current  insurance  coverage  is in the amount of $1
million per  occurrence  and $2 million in  aggregate.  The Company  also has an
umbrella  policy in the amount of $5 million.  In certain  cases the Company has
indemnification  arrangements  in place with its strategic  partners who will be
selling  Company  developed  products  under the  partner's  label.  There is no
assurance  that  the  Company  will  maintain  product  liability  insurance  on
acceptable terms in the future or that such insurance will be available. Product
liability claims could have a material adverse effect on the Company.

         Uncertainty in the  Healthcare  Industry.  The  healthcare  industry is
subject to changing  political,  economic  and  regulatory  influences  that may
affect the procurement practices and operations of healthcare facilities. During
the past several years,  the  healthcare  industry has been subject to increased
government  regulation of reimbursement  rates and capital  expenditures.  Among
other  things,   third-party  payers  are  increasingly  attempting  to  contain
healthcare  costs  by  limiting  both  coverage  and  reimbursement  levels  for
healthcare products and procedures. Because prices of the Company's products may
exceed  the  price of  conventional  products,  the  cost  control  policies  of
third-party payers,  including government agencies,  may adversely affect use of
the Company's  products.  The Company  believes that the costs  associated  with
accidental  needlesticks,  however,  exceed  the  procurement  costs  of  safety
products such as those of the Company.

         There are numerous  proposals to reform the U.S.  healthcare system and
the healthcare  systems of various states including the safety  initiatives that
have been passed in five states and are under  consideration in other states and
on a national  level.  OSHA also issued a national  directive  in November  1999
requiring  use of  safety  medical  devices.  Many of  these  proposals  seek to
increase  government  involvement  in  healthcare,  lower  reimbursement  rates,
contain costs and otherwise  change the operating  environment for the Company's
prospective customers. Healthcare providers may react to these proposals and the
uncertainty surrounding such proposals by curtailing or deferring investments in
new technology  and new products,  including  those of the Company.  The Company
cannot predict what impact,  if any, such proposals or healthcare  reforms might
have on the Company's financial condition and results of operations.

         Management/Dependence  on  Key  Personnel/Board.  The  success  of  the
Company  depends upon the skills,  experience  and efforts of its management and
other key  personnel.  Should the services of one or more members of its present
management  or other key  personnel  become  unavailable  to the Company for any
reason,  the business of the Company  could be adversely  affected.  There is no
assurance that the Company will be able to retain existing  employees or attract
new  employees of the caliber  needed to achieve the Company's  objectives.  The
Board  currently  consists  of five  members,  two of whom are  employed  by the
Company.

         Market  Volatility.  Market prices of securities of medical  technology
companies  are  highly  volatile  from time to time.  The  trading  price of the
Company's  securities  may be  significantly  affected  by  factors  such as the
announcement  of new  product or  technical  innovations  by the  Company or its
competitors, proposed changes in the regulatory environment, or by other factors
that may or may not relate directly to the Company. Sales of substantial amounts
of Common Stock  (including  stock which may be issued upon exercise of warrants
or stock options),  or the perception that such sales may occur, could adversely
affect the trading price of the Common Stock.

         No Assurance of Dividends.  The Company has never paid dividends on its
Common  Stock.  The payment of  dividends,  if any,  on the Common  Stock in the
future is at the  discretion  of the Board and will  depend  upon the  Company's
earnings, if any, capital  requirements,  financial condition and other relevant

                                       8
<PAGE>

factors.  The Board does not intend to declare any dividends on the Common Stock
in the foreseeable future.

         Limitations  on  Director  Liability.   The  Company's  Certificate  of
Incorporation  provides,  as permitted by Delaware  law,  that a director of the
Company shall not be personally  liable to the Company or its  stockholders  for
monetary  damages  for any action or failure to take any  action,  with  certain
exceptions.  These  provisions  may discourage  stockholders  from bringing suit
against  a  director  for  breach  of duty  and may  reduce  the  likelihood  of
derivative litigation brought by stockholders on behalf of the Company against a
director.   In  addition,   the  Company  has  agreed  and  its  Certificate  of
Incorporation and Bylaws provide, for mandatory indemnification of directors and
officers to the fullest extent permitted by Delaware law and it has entered into
contracts with its directors and officers providing for such indemnification.

         Anti-Takeover  Provisions of Certificate and Bylaws. The Certificate of
Incorporation  of the Company  provides for the division of the Board into three
classes  substantially  equal in number.  At each annual meeting of stockholders
one class of  directors is to be elected for a three-year  term.  Amendments  to
this  provision  must be approved by a  two-thirds  vote of all the  outstanding
stock  entitled to vote; the number of directors may be changed by a majority of
the entire Board or by a two-thirds  vote of the  outstanding  stock entitled to
vote.  Meetings  of  stockholders  may be called  only by the  Board,  the Chief
Executive  Officer or the President of the Company,  and stockholder  action may
not be taken by written  consent.  These provisions could have the effect of (i)
discouraging  attempts at  non-negotiated  takeovers  of the  Company  which may
provide  for  stockholders  to receive a premium  price for their  stock or (ii)
delaying  or   preventing  a  change  of  control  of  the  Company  which  some
stockholders may believe is in their interest.

         Effect  of  the  Issuance  of  Preferred  Stock.  The  Company  has  an
authorized  class of  preferred  stock,  shares of which may be issued  with the
approval  of its  Board on such  terms  and with such  rights,  preferences  and
designations  as the Board  may  determine.  Issuance  of  additional  series of
preferred  stock,  depending  upon  the  rights,  preferences  and  designations
thereof,  may have the effect of delaying,  deterring or  preventing a change in
control of the Company. In addition,  certain "anti-takeover"  provisions of the
Delaware General  Corporation Law, among other things,  may restrict the ability
of stockholders to effect a merger or business  combination or obtain control of
the  Company  and  may  be  considered  disadvantageous  by  some  stockholders.
Management  of the  Company  presently  does not  intend to issue any  shares of
preferred  stock.  Preferred stock may,  however,  be issued at some future date
which  stock  might  have  substantially  more  than one vote per share or other
provisions designed to deter a change in control of the Company. The issuance of
such  stock to a  limited  group  of  management  stockholders  may vest in such
persons absolute voting control of the Company,  including,  among other things,
the ability to elect all of the directors,  control certain matters submitted to
a vote of  stockholders  and  prevent  any change in  management  despite  their
performance.  Also,  preferred  stock may have the  right to vote  upon  certain
matters as a separate class.

                                       9
<PAGE>

                                   SIGNATURES

         In  accordance  with  Section  13 or 15(d)  of the  Exchange  Act,  the
registrant  caused  this  report to be signed on its behalf by the  undersigned,
thereunto duly authorized.

                                             SPECIALIZED HEALTH PRODUCTS
                                             INTERNATIONAL, INC.
                                             (Registrant)

Date: April 25, 2000                         By  /s/ David A. Robinson
                                                ----------------------
                                             David A. Robinson
                                             President, Chief Executive Officer
                                             and Director

         In accordance  with the Exchange Act, this report has been signed below
by the following  persons on behalf of the  registrant and in the capacities and
on the dates indicated.

     Signature                          Title                           Date

/s/ David A. Robinson        President, Chief Executive Officer   April 25, 2000
- -------------------------    and Director (Principal
David A. Robinson            Executive Officer)


/s/ Charles D. Roe           Vice President, Chief Financial      April 25, 2000
- -------------------------    Officer, Secretary and Treasurer
Charles D. Roe               (Principal Financial and Accounting
                             Officer)


/s/ Gale H. Thorne           Director and Vice President          April 25, 2000
- -------------------------
Gale H. Thorne


/s/ David G. Hurley          Director                             April 25, 2000
- -------------------------
David G. Hurley


/s/ David T. Rovee           Director                             April 25, 2000
- -------------------------
David T. Rovee


/s/ Robert R. Walker         Director                             April 25, 2000
- -------------------------
Robert R. Walker

                                       10


© 2022 IncJournal is not affiliated with or endorsed by the U.S. Securities and Exchange Commission