As filed with the Securities and Exchange Commission on February 12, 1998
Registration Statement No. 333-
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_________________________
FORM S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
_________________________
Anika Therapeutics, Inc.
(Exact name of Registrant as specified in its charter)
Massachusetts 04-3145961
(State of incorporation) (I.R.S. Employer Identification Number)
236 West Cummings Park
Woburn, Massachusetts 01801
(781) 932-6616
(Address, including zip code, and telephone number, including area code, of
Registrant's principal executive offices)
_______________________________
J. Melville Engle
President
Anika Therapeutics, Inc.
236 West Cummings Park
Woburn, Massachusetts 01801
(781) 932-6616
(Name, address, including zip code, and telephone number, including area code,
of agent for service)
____________________________
With copies to:
H. DAVID HENKEN, ESQ.
Goodwin, Procter & Hoar LLP
Exchange Place
53 State Street
Boston, Massachusetts 02109-2881
(617) 570-1000
Approximate date of commencement of proposed sale to the public: From time to
time after this Registration Statement becomes effective.
If the only securities being registered on this form are being offered pursuant
to dividend or interest reinvestment plans, please check the following box. o
If any of the securities being registered on this form are to be offered on a
delayed or continuous basis pursuant to Rule 415 under the Securities Act of
1933, other than securities offered only in connection with dividend or interest
reinvestment plans, check the following box. x
If this Form is filed to register additional securities for an offering
pursuant to Rule 462(b) under the Securities Act, please check the following box
and list the Securities Act registration statement number of the earlier
effective registration statement for the same offering. ______________
If this Form is a post-effective amendment filed pursuant to Rule 462(c) under
the Securities Act, check the following box and list the Securities Act
registration statement number of the earlier effective registration statement
for the same offering. o ______________
If delivery of the prospectus is expected to be made pursuant to Rule 434,
please check the following box. o ____________________________
<PAGE>
CALCULATION OF REGISTRATION FEE
<TABLE>
<CAPTION>
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<S> <C> <C> <C> <C>
Title of Amount Proposed Proposed
Shares to be Maximum Offering Maxumum Aggregate Amount of
to be Registered Offering Price Offering Registration
Registered Per Share (1)(2) Price (1)(2) Fee
- ----------------------------------------------------------------------------
Common Stock,
$.01 par 203,700 $7.969 $1,623,285 $478.87
value per shares
share
============================================================================
(1) Estimated solely for the purpose of calculating the registration fee
pursuant to Rule 457 of the Securities Act of 1933, as amended.
(2) Pursuant to Rule 457(c) under the Securities Act of 1933, the registration
fee has been calculated based upon the average of the bid and ask prices per
share of Common Stock on the NASDAQ National Market System on February 10, 1998.
</TABLE>
The registrant hereby amends this registration statement on such date or dates
as may be necessary to delay its effective date until the registrant shall file
a further amendment which specifically states that this registration statement
shall thereafter become effective in accordance with Section 8(a) of the
Securities Act of 1933 or until the registration statement shall become
effective on such date as the Commission, acting pursuant to said Section 8(a),
may determine.
<PAGE>
PROSPECTUS
203,700 Shares
anika therapeutics, inc.
[LOGO]
Common Stock
_______________
This prospectus relates to the offer and sale of 203,700 shares of common
stock, $.01 par value per share ("Common Stock"), of Anika Therapeutics, Inc.
("Anika" or the "Company") issued upon the exercise of warrants to purchase
Common Stock by a warrantholder of the Company (the "Selling Stockholder").
See "Selling Stockholders" and "Plan of Distribution."
The Common Stock is quoted on NASDAQ Automated Quotation National Market
system ("NASDAQ") under the trading symbol "ANIK."
_______________
See "Risk Factors" beginning on page 4 for a discussion of certain risk
factors which should be considered by prospective investors in purchasing shares
of Common Stock offered hereby.
_______________
THESE SECURITIES HAVE NOT BEEN APPROVED OR DISAPPROVED BY THE
SECURITIES AND EXCHANGE COMMISSION OR ANY STATE SECURITIES
COMMISSION NOR HAS THE SECURITIES AND EXCHANGE COMMISSION OR
ANY STATE SECURITIES COMMISSION PASSED UPON THE ACCURACY OR
ADEQUACY OF THIS PROSPECTUS. ANY REPRESENTATION TO THE
CONTRARY IS A CRIMINAL OFFENSE.
_______________
The 203,700 shares of Common Stock offered hereby (the "Shares") may be sold
from time to time by the Selling Stockholder on NASDAQ on terms to be determined
at the times of such sales. The Selling Stockholder may also make private sales
directly or through a broker or brokers. Alternatively, the Selling Stockholder
may from time to time offer Shares offered hereby to or through underwriters,
dealers or agents, who may receive consideration in the form of discounts and
commissions; such compensation, which may be in excess of ordinary brokerage
commissions, may be paid by the Selling Stockholder and/or the purchasers of the
Shares offered hereby for whom such underwriters, dealers or agents may act.
The Company is registering the Shares to satisfy the Company's contractual
obligations to the Selling Stockholder to use reasonable efforts to register
such Shares, but the registration of the Shares does not necessarily mean
that any of the Shares will be offered or sold hereunder. See "Selling
Stockholders" and "Plan of Distribution."
The Selling Stockholder and any dealers or agents that participate in the
distribution of the Securities offered hereby may be deemed to be "underwriters"
as defined in the Securities Act of 1933, as amended (the "Securities Act"),
and any profit on the sale of such Shares offered hereby by them and any
discounts, commissions or concessions received by any such dealers or agents
might be deemed to be underwriting discounts and commissions under the
Securities Act.
The Company received proceeds in the amount of $668,136 upon exercise of the
Warrants (as defined herein). Such proceeds will be added to the Company's
working capital and used for general corporate purposes. The Company will not
otherwise receive any of the proceeds from the sale of Common Stock offered
hereby. The Company has agreed to bear all of the expenses in connection with
the registration and sale of the Shares (other than underwriting discounts
and selling commissions, any applicable transfer taxes and the fees and expenses
of counsel or other advisors to the Selling Stockholder).
_______________
ORTHOVISC , HYVISC and INCERT are registered trademarks of the Company.
All other trademarks, servicemarks or tradenames referred to in this Prospectus,
including AMVISC , AMVISC Plus and OSSIGEL , are the property of their
respective owners.
The date of this Prospectus is February 12, 1998
<PAGE>
AVAILABLE INFORMATION
The Company is subject to the informational requirements of the Securities
Exchange Act of 1934, as amended (the "Exchange Act"), and in accordance
therewith files reports, proxy statements and other information with the
Securities and Exchange Commission (the "SEC" or the "Commission"). Such
reports, proxy statements and other information can be inspected and copied
at the public reference facilities maintained by the Commission at 450 Fifth
Street, N.W., Room 1024, Washington, D.C. 20549, and at the Commission's
Regional Offices at 7 World Trade Center, 13th Floor, New York, New York 10048,
and Northwestern Atrium Center, 500 W. Madison Street, Suite 1400, Chicago,
Illinois 60661-2511. Copies of such materials can be obtained upon written
request from the Public Reference Section of the Commission at 450 Fifth
Street, N.W., Room 1024, Washington, D.C. 20549, at prescribed rates. The
Company is required to file electronic versions of these reports, proxy
statements and other information with the Commission via the Commission's
Electronic Data Gathering, Analysis and Retrieval ("EDGAR") System. The
Commission maintains a site on the World Wide Web (http://www.sec.gov) that
contains all EDGAR filings. In addition, the Common Stock is listed on
NASDAQ under the symbol "ANIK" and the aforementioned materials may also be
inspected at the offices of the National Association of Securities Dealers,
Inc., 1735 K Street, N.W., Washington, D.C. 20006.
The Company has filed with the Commission a Registration Statement on Form
S-3 (the "Registration Statement") under the Securities Act with respect to the
Common Stock. This Prospectus, which constitutes a part of the Registration
Statement, does not contain all of the information set forth in the Registration
Statement, certain parts of which are omitted in accordance with the rules
and regulations of the Commission. The Registration Statement, including
exhibits thereto, may be inspected and copied at the locations described above.
Statements contained in this Prospectus as to the contents of any contract,
agreement or other document referred to are not necessarily complete. With
respect to each such contract, agreement or other document filed as an exhibit
to the Registration Statement, reference is made to the exhibit for a more
complete description of the matter involved, and each such statement shall be
deemed qualified in its entirety by such reference.
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
The following documents previously filed by the Company with the Commission
pursuant to the Exchange Act are incorporated by reference in this Prospectus:
(i) the Company's Annual Report on Form 10-KSB for the fiscal year ended August
31, 1996, (ii) the Company's Quarterly Reports on Form 10-QSB for the fiscal
quarters ended November 30, 1996, March 31, 1997, June 30, 1997 and September
30, 1997, (iii) the Company's Transition Report on Form 10-QSB for the
transition period from September 1, 1996 to December 31, 1996, (iv) the
Company's Current Report on Form 8-K dated December 4, 1996, and (v) the
description of the Common Stock of the Company contained in the Company's
Registration Statement on Form 10, filed on March 5, 1993, as amended and
updated by the description of the Common Stock contained in the Company's
Registration Statement on Form SB-2, filed on October 29, 1997, including all
amendments and reports updating such description.
All documents filed by the Company pursuant to Section 13(a), 13(c), 14 or
15(d) of the Exchange Act subsequent to the date of this Prospectus and prior to
the termination of this offering shall be deemed to be incorporated by reference
in this Prospectus and to be a part hereof from the date of filing of such
documents.
The Company will provide, without charge, to each person, including any
beneficial owner, to whom a copy of this Prospectus is delivered, at the written
or oral request of such person, a copy of any or all of the documents
incorporated herein by reference (other than exhibits thereto, unless such
exhibits are specifically incorporated by reference into such documents).
Written requests for such copies should be directed to Chief Financial Officer,
Anika Therapeutics, Inc., 236 West Cummings Park, Woburn, Massachusetts 01801
(Telephone: 781-932-6616).
Any statement contained herein or in a document incorporated or deemed to be
incorporated herein by reference shall be deemed to be modified or superseded
for purposes of this Prospectus to the extent that a statement contained herein
or in any subsequently filed document that is incorporated by reference herein
modifies or supersedes such statement. Any such statement so modified or
superseded shall not be deemed, except as so modified or superseded, to
constitute a part of this Prospectus.
<PAGE>
THE COMPANY
Anika Therapeutics, Inc. develops, manufactures and commercializes
therapeutic products and devices intended to promote the protection and healing
of bone, cartilage and soft tissue. These products are based on hyaluronic
acid ("HA"), a naturally-occurring, biocompatible polymer found throughout
the body. Due to its unique biophysical and biochemical properties, HA plays
an important role in a number of physiological functions such as the protection
and lubrication of soft tissues and joints, the maintenance of the structural
integrity of tissues, and the transport of molecules to and within cells. The
Company has been developing HA and HA based products since 1983. The
Company's currently marketed products consist of ORTHOVISC , which is an HA
product used in the treatment of some forms of osteoarthritis ("OA") in
humans and HYVISC , which is an HA product used in the treatment of equine
osteoarthritis. ORTHOVISC is currently approved for marketing in Canada and
Europe; in the U.S. ORTHOVISC is currently limited to investigational use only.
The Company manufactures AMVISC and AMVISC Plus , which are HA products used as
viscoelastic supplements in ophthalmic surgery, for Chiron Vision, a
subsidiary of Chiron Corporation. The Company is currently developing INCERT ,
which is an HA based product designed for use in the prevention of
post-surgical adhesions. In addition, the Company is collaborating with
Orquest, Inc. to develop OSSIGELTM, an injectable formulation of basic
fibroblast growth factor combined with HA designed to accelerate the healing of
bone fractures.
The Company was a division of MedChem Products, Inc. ("MedChem") until
1993. The Company was incorporated under the laws of Massachusetts and became
an independent publicly-traded entity in May 1993 when MedChem distributed
all of the then outstanding shares of Common Stock of the Company to MedChem
stockholders as a dividend. The Company's principal executive offices are
located at 236 West Cummings Park, Woburn, Massachusetts 01801, and its
telephone number is (781) 932-6616.
As used in this Prospectus, the terms "Anika" and the "Company" refer to
Anika Therapeutics, Inc. and its predecessor unless the context otherwise
requires.
<PAGE>
This Prospectus, including the information incorporated herein by
reference, contains forward-looking statements within the meaning of Section 27A
of the Securities Act and Section 21E of the Exchange Act. The Company's actual
results could differ materially from those projected in the forward-looking
statements set forth in this Prospectus including the information
incorporated herein by reference. Investors should carefully consider the
discussion of risk factors below, in addition to the other information
contained in this Prospectus, in connection with an investment in the Shares
offered hereby.
RISK FACTORS
In addition to the other information contained or incorporated by reference
in this Prospectus, the following factors should be considered carefully in
evaluating an investment in the shares of Common Stock offered by this
Prospectus.
History of Losses; Uncertainty of Future Profitability
The Company incurred annual operating losses since its inception in May 1993
until the year ended December 31, 1997. The continued development of the
Company's products will require the commitment of substantial resources to
conduct research and preclinical and clinical development programs, and to
establish sales and marketing capabilities. The Company incurred substantial
and increasing operating losses through December 31, 1996 and, although the
Company had net income of $285,916 for the nine-month period ended December
31, 1997, the ability of the Company to reach sustained profitability is highly
uncertain. To achieve sustained profitability the Company must, among other
things, successfully complete development of certain of its products, obtain
regulatory approvals and establish sales and marketing capabilities for certain
of its products. There can be no assurance that the Company will be able to
achieve sustained profitability.
Competition
The Company competes with many companies, including large pharmaceutical
companies and specialized medical products companies. Many of these companies
have substantially greater financial and other resources, larger research and
development staffs, more extensive marketing and manufacturing organizations
and more experience in the regulatory process than the Company. The Company
also competes with academic institutions, governmental agencies and other
research organizations which may be involved in research, development and
commercialization of products. Because a number of companies are developing HA
products for similar applications, the successful commercialization of a
particular product will depend in part upon the ability of the Company to
complete clinical studies and obtain marketing and foreign regulatory approvals
from the United States Food and Drug Administration ("FDA") prior to its
competitors. There can be no assurance that the Company will be able to
compete against current or future competitors or that competition will not have
a material adverse effect on the Company's business, financial condition and
results of operations.
Fluctuations in Quarterly Operating Results
The Company's quarterly operating results may fluctuate as a result of a
number of factors, including timing of approvals of new products of the
Company, its competitors or its customers, slower-than-anticipated market
penetration rates of current products, temporary delays in obtaining certain
product components from suppliers and the ability of the Company to establish
marketing and distribution arrangements with strategic partners. A significant
portion of the Company's expenses is relatively fixed in nature and the Company
may not be able to reduce spending in response to shortfalls or delays in
revenues. Such shortfalls or delays may result in a material adverse effect on
the Company's business, financial condition and results of operations. As a
result, the Company believes that period-to-period comparisonsof its results
of operations are not necessarily meaningful and should not be relied upon as
indicators of future performance. Due to the foregoing factors, it is likely
that in one or more future fiscal quarters the Company's operating results may
be below the expectations of equity research analysts and investors. Such an
occurrence could have a material adverse effect on the market price of the
Common Stock.
<PAGE>
Comprehensive Government Regulation; No Assurance of FDA Approval
The Company's products, product development activities, manufacturing
processes, and current and future sales and marketing are subject to extensive
and rigorous regulation by the FDA and comparable agencies in foreign countries.
In the United States, the FDA regulates the marketing, advertising, promotion,
and distribution of medical devices, drugs, and biologics, as well as
testing, manufacturing, labeling, recordkeeping, and reporting activities
for such products.
Medical products regulated by the FDA are generally classified as devices
and/or drugs and/or biologics. Product development and approval within the FDA
framework takes a number of years and involves the expenditure of substantial
resources. There can be no assurance that the FDA will grant approval for the
Company's new products on a timely basis if at all, or that FDA review will not
involve delays that will adversely affect the Company's ability to
commercialize additional products or expand permitted uses of existing products,
or that the regulatory framework will not change, or that additional
regulation will not arise at any stage of the Company's product development
process which may adversely affect approval of or delay an application or
require additional expenditures by the Company. In the event the Company's
future products are regulated as human drugs or biologics, the FDA's review
process typically would be substantially longer and more expensive than the
review process for devices.
The Company's ORTHOVISC product is currently regulated as a Class III device
by the FDA. Class III devices are those that generally must receive pre-market
approval by the FDA to ensure their safety and effectiveness (e.g.
life-sustaining, life-supporting and implantable or new devices which have
not been found to be substantially equivalent to legally marketed devices)
and require clinical testing to ensure safety and effectiveness and FDA approval
prior to marketing and distribution. In order for the Company to commercially
distribute ORTHOVISC in the U.S., it must obtain FDA approval of a Pre-Market
Approval Application ("PMA"). The Company submitted a PMA for ORTHOVISC to the
FDA for approval on December 31, 1997. The PMA approval process can be
expensive, uncertain and lengthy. A number of devices for which pre-market
approval has been sought have never been approved for marketing. The review
of an application often occurs over a protracted time period and may take
two years or more from the filing date to complete. There can be no assurance
that the FDA will approve a PMA application for ORTHOVISC on a timely basis, if
at all, or that the FDA review will not involve delays that will affect the
Company's ability to commercialize additional products or expand permitted uses
of existing products. Furthermore, even if granted, the approval may include
significant limitations on the indications for use for which the product may
be marketed.
The Company's developmental HA products, including INCERT and HA
oligosaccharides, have not obtained regulatory approval in the U.S. for
investigational use and/or commercial marketing and sale. The Company believes
that INCERT will be regulated as a Class III medical device and HA
oligosaccharides will be regulated as a drug, although there can be no
assurance that such products will not be otherwise classified. Before
undertaking clinical trials in the U.S. to support a PMA, the Company must
apply for and obtain FDA and/or institutional review board ("IRB") approval of
an investigation device exemption ("IDE"). There can be no assurance that the
Company will be permitted to undertake clinical trials of these or other
future products in the U.S. or that clinical trials will demonstrate that the
products are safe and effective or otherwise satisfy the FDA's pre-market
approval requirements. Orquest has not received regulatory approval in the U.S.
for the investigational use and/or commercial marketing and sale of OSSIGEL.
OSSIGEL may be regulated as a Class III medical device, a biologic, a drug or a
combination thereof. There can be no assurance that Orquest will be permitted
to undertake clinical trials of OSSIGEL or, if clinical trials are permitted,
that such clinical trials will demonstrate that OSSIGEL is safe and
effective or otherwise satisfy FDA requirements.
Once obtained, marketing clearance can be withdrawn by the FDA due to failure
to comply with regulatory standards or the occurrence of unforeseen problems
following initial clearance. The Company may be required to make further
filings with the FDA under certain circumstances. The FDA's regulations require
agency approval of a PMA supplement for certain changes if they affect the
safety and effectiveness of an approved device, including, but not limited to,
new indications for use, labeling changes, the use of a different facility to
manufacture, process or package the device, changes in manufacturing methods
or quality control systems and changes in performance or design specifications.
Failure by the Company to receive approval of a PMA supplement regarding the
use of a different manufacturing facility or any other change affecting the
safety or effectiveness of an approved device on a timely basis, or at all,
would have a material adverse effect on the Company's business, financial
condition and results of operations. The FDA could also limit or prevent the
manufacture or distribution of the Company's products and has the power to
require the recall of such products. Significant delay or cost in obtaining, or
failure to obtain FDA clearance to market products, any FDA limitations on the
use of the Company's products, or any withdrawal or suspension of clearance by
the FDA could have a material adverse effect on the Company's business,
financial condition and results of operations.
<PAGE>
In addition, all FDA-approved products manufactured by the Company must be
manufactured in compliance with FDA's Good Manufacturing Practices ("GMP")
regulations or, for medical devices, FDA's Quality System Regulations ("QSR").
Ongoing compliance with GMP, QSR and other applicable regulatory requirements
is monitored through periodic inspection by state and federal agencies,
including the FDA. The FDA may inspect the Company and its facilities from
time to time to determine whether the Company is in compliance with
regulations relating to medical device and manufacturing companies,
including regulations concerning manufacturing, testing, quality control and
product labeling practices. There can be no assurance that the Company will be
able to comply with current or future FDA requirements applicable to the
manufacture of products.
FDA regulations depend heavily on administrative interpretation and there can
be no assurance that the future interpretations made by the FDA or other
regulatory bodies, with possible retroactive effect, will not adversely affect
the Company. In addition, changes in the existing regulations or adoption of
new governmental regulations or policies could prevent or delay regulatory
approval of the Company's products.
Failure to comply with applicable regulatory requirements could result in,
among other things, warning letters, fines, injunctions, civil penalties, recall
or seizure of products, total or partial suspension of production, refusal of
the FDA to grant pre-market clearance or pre-market approval for devices,
withdrawal of approvals and criminal prosecution.
In addition to regulations enforced by the FDA, the Company is subject to
other existing and potential future federal, state, local and foreign
regulations. International regulatory bodies often establish regulations
governing product standards, packing requirements, labeling requirements,
import restrictions, tariff regulations, duties and tax requirements. To enable
the Company to market its products in Europe, the Company was required to
receive a "CE" marking certification, an international symbol of quality and
compliance with the applicable European medical device directive. In October
1996, the Company received an EC Design Examination and an EC Quality System
Certificate from a European Notified Body, which entitles the Company to affix
a CE marking on ORTHOVISC for the treatment of osteoarthritis in synovial
joints. There can be no assurance that the Company will be able to achieve
and/or maintain compliance required for CE marking or other foreign regulatory
approvals for any or all of its products or that it will be able to produce
its products in a timely and profitable manner while complying with applicable
requirements. Federal, state, local and foreign regulations regarding the
manufacture and sale of medical products are subject to change. The Company
cannot predict what impact, if any, such changes might have on its business.
The requirements relating to the conduct of clinical trials, product
licensing, pricing and reimbursement also vary widely from country to country.
The process of obtaining approvals from the FDA and other regulatory
authorities can be costly, time consuming, and subject to unanticipated delays.
There can be no assurance that approvals of the Company's products will be
granted or that the Company will have the necessary funds to develop certain of
such products. Any failure to obtain, or delay in obtaining, such approvals
could adversely affect the ability of the Company to market its products.
Uncertainty Regarding Success of Clinical Trials
Several of the Company's products, including INCERT and HA oligosaccharides,
as well as the products of the Company's collaborative partners, including
OSSIGEL, will require clinical trials to determine their safety and efficacy in
humans for various conditions. There can be no assurance that the Company or
its collaborative partners will not encounter problems that will cause it to
delay or suspend clinical trials of any of these products. In addition, there
can be no assurance that such clinical trials, if completed, will ultimately
demonstrate these products to be safe and efficacious.
<PAGE>
Dependence Upon Marketing Partners
The Company does not plan to directly market and sell its current products to
customers. Therefore, the Company's success will be dependent upon the efforts
of its marketing partners and the terms and conditions of the Company's
relationships with such marketing partners. The Company currently
manufactures AMVISC and AMVISC Plus for Chiron Vision under a non-exclusive
fixed price, five-year supply agreement which contains stated minimum
annual purchase obligations and terminates on December 31, 2001. Since
January 1, 1997, Chiron Vision has purchased AMVISC and AMVISC Plus in amounts
substantially in excess of the minimum purchase obligations set forth in the
AMVISC supply contract. There can be no assurance that the acquisitions will
be consummated or if consummated, that Bausch & Lomb, Inc. will continue to
purchase AMVISC and AMVISC Plus at levels beyond the stated minimum annual
purchase obligations. Any such decrease in orders under the AMVISC supply
contract could have a material adverse effect on the Company's business,
financial condition and results of operations. For the nine months ended
September 30, 1997 and 1996, AMVISC and AMVISC Plus sales through Chiron Vision
accounted for 84% and 90% of net sales, respectively.
On November 7, 1997, the Company entered into a distribution agreement with
Zimmer, Inc., a subsidiary of Bristol-Myers Squibb Company ("Zimmer") for the
exclusive marketing and distribution of ORTHOVISC in the United States, Canada
and selected countries in the Asia-Pacific region. While the agreement
provides for future payments to the Company of up to $20.5 million (which
includes the right upon attaining certain milestones, at Zimmer's election,
to make an equity investment in the Company equal to the greater of $2.5 million
or 9.9% of the then outstanding Common Stock (but not to exceed 19.9% of the
then outstanding Common Stock) at a premium to the then current market price),
such payments are contingent upon the achievement of certain enumerated
regulatory approval and sales milestones. There can be no assurance that such
milestones will be met on a timely basis or at all and, accordingly, that any
such payments will be received by the Company. In addition, Zimmer has the
right to terminate the agreement on August 1, 1998 if certain specified events
occur prior to that date and upon payment to Anika of $1.0 million in cash.
These circumstances include (i) the failure of Zimmer to sell a stated minimum
number of units of ORTHOVISC during the second quarter of 1998 or the failure
of a competitor of the Company to report enumerated sales minimums during the
first two quarters of 1998, (ii) an FDA requirement of additional clinical
trials for ORTHOVISC or the FDA's acceptance for filing by a party other than
Anika or its primary competitors of a PMA for an injectable HA product for the
treatment of OA in humans without requiring submission of an IDE clinical
study to support the application, (iii) both Synvisc and Hyalgan are either
voluntarily or involuntarily withdrawn from the U.S. market, or (iv) if Zimmer
undergoes a company-wide restructuring prior to June 30, 1998 which results in
Zimmer's determination that the knee implant product line is not a core
product. There can be no assurance that any of these events will not occur or,
if any such event does occur, that Zimmer will not elect to terminate the
agreement. Any such termination would have a material adverse effect on the
Company's ability to market ORTHOVISC, which may have a material adverse effect
on the Company's future operating results.
The Company will need to obtain the assistance of additional marketing
partners for new products which are brought to market and existing products
brought to new markets. There can be no assurance that such additional partners
will be available or that such partners will agree to market the Company's
products on acceptable terms. The failure to establish strategic partnerships
for the marketing and distribution of the Company's products on acceptable
terms would have a material adverse effect on the Company's business, financial
condition and results of operations.
Uncertainty of Market Acceptance of New Products
The Company's success will depend in part upon the acceptance of the Company's
new products by the medical community, hospitals and physicians and other
health care providers, and third-party payors. Such acceptance may depend upon
the extent to which the medical community perceives the Company's products as
safer, more effective or cost-competitive than other similar products.
Ultimately, for the Company's new products to gain general market acceptance,
it will also be necessary for the Company to develop marketing partners for the
distribution of its products. There can be no assurance that the Company's new
products will achieve significant market acceptance on a timely basis, or at
all. Failure of some or all of the Company's new products to achieve
significant market acceptance could have a material adverse effect on the
Company's business, financial condition and results of operations.
<PAGE>
Dependence on Patents and Proprietary Technology
The Company's success will depend, in part, on its ability to obtain and
enforce patents, protect trade secrets, obtain licenses to technology owned
by third parties when necessary, and conduct its business without infringing
the proprietary rights of others. The patent positions of pharmaceutical,
medical products and biotechnology firms, including the Company, can be
uncertain and involve complex legal and factual questions. There can be no
assurance that any patent applications will result in the issuance of patents
or, if any patents are issued, whether they will provide significant
proprietary protection or commercial advantage, or will not be circumvented
by others. In the event a third party has also filed one or more patent
applications for any of its inventions, the Company may have to participate
in interference proceedings declared by the U.S. Patent and Trademark Office
("PTO") to determine priority of invention (see below), which could result in
failure to obtain or the loss of patent protection for the inventions and the
loss of any right to use the inventions. Even if the eventual outcome is
favorable to the Company, such interference proceedings could result in
substantial cost to the Company. Filing and prosecution of patent applications,
litigation to establish the validity and scope of patents, assertion of patent
infringement claims against others and the defense of patent infringement claims
by others can be expensive and time consuming. There can be no assurance that in
the event that any claims with respect to any of the Company's patents, if
issued, are challenged by one or more third parties, that any court
or patent authority ruling on such challenge will determine that such patent
claims are valid and enforceable. An adverse outcome in such litigation could
cause the Company to lose exclus ivity covered by the disputed rights. If a
third party is found to have rights covering products or processes used by the
Company, the Company could be forced to cease using the technologies or
marketing the products covered by such rights, could be subject to significant
liabilities to such third party, and could be required to license technologies
from such third party. Furthermore, even if the Company's patents are
determined to be valid, enforceable, and broad in scope, there can be no
assurance that competitors will not be able to design around such patents and
compete with the Company using the resulting alternative technology.
The Company has a policy of seeking patent protection for patentable aspects
of its proprietary technology. The Company co-owns certain United States patents
and a patent application which claim certain adhesion prevention uses and
certain drug delivery uses of HA, and solely owns patents directed to certain
manufacturing processes. The Company also holds an exclusive license from Tufts
University to use technologies claimed in a United States patent application
which relate to the anti-metastasis applications of HA oligosaccharides. The
Company's issued patents expire between 2007 and 2015 and the license
expires upon expiration of all related patents. The Company intends to seek
patent protection with respect to products and processes developed in the
course of its activities when it believes such protection is in its best
interest and when the cost of seeking such protection is not inordinate.
However, no assurance can be given that any patent application will be filed,
that any filed applications will result in issued patents or that any issued
patents will provide the Company with a competitive advantage or will not be
successfully challenged by third parties. The protections afforded by patents
will depend upon their scope and validity, and others may be able to design
around the Company's patents. The Company's issued patents and any patents
which arise from the Company's licensed application would provide
competitive protection, if at all, only in the United States. The Company has
not, to date, pursued foreign patents equivalent to those issued or applied
for in the United States.
Other entities have filed patent applications for or have been issued patents
concerning various aspects of HA-related products or processes. There can be no
assurance that the products or processes developed by the Company will not
infringe the patent rights of others in the future. Any such infringement may
have a material adverse effect on the Company's business, financial
condition and results of operations. In particular, the Company has received
notice from the PTO that a third party is attempting to provoke a patent
interference with respect to one of the Company's co-owned patents covering the
use of INCERT for post-surgical adhesion prevention. Although the Company
believes that an interference will be declared by the PTO, it is too early to
determine the merits of the interference or the effect, if any, the
interference will have on the Company's marketing of INCERT for this use. The
existence of the interference proceeding may have a negative impact on the
marketing of the INCERT product, and no assurance can be given that the Company
would be successful in any such interference proceeding. If the third-party
interference were to be decided adversely to the Company, involved claims of
the Company's patent would be cancelled, the Company's marketing of the
INCERT product may be materially and adversely affected and the third party
may enforce patent rights against the Company which could prohibit the sale and
use of the INCERT products, which could have a material adverse effect on the
Company's future operating results.
<PAGE>
The Company also relies upon trade secrets and proprietary know-how for
certain unpatented aspects of its technology. To protect such information, the
Company requires all employees, consultants and licensees to enter into
confidentiality agreements limiting the disclosure and use of such
information. There can be no assurance that these agreements provide
meaningful protection or that they will not be breached, that the Company would
have adequate remedies for any such breach, or that the Company's trade secrets,
proprietary know-how, and technological advances will not otherwise become
known to others. In addition, there can be no assurance that, despite
precautions taken by the Company, others have not and will not obtain access to
the Company's proprietary technology. Further, there can be no assurance that
third parties will not independently develop substantially equivalent
or better technology.
Pursuant to the AMVISC supply contract the Company has agreed to grant Chiron
Vision a royalty-free, worldwide, exclusive license to the Company's
manufacturing and product inventions which relate to AMVISC products,
effective on December 31, 2001, the termination date of the AMVISC supply
contract which became effective on January 1, 1997. Upon expiration of the
AMVISC supply contract, there can be no assurance that Chiron Vision will
continue to use the Company to manufacture AMVISC and AMVISC Plus. If Chiron
Vision discontinues the use of the Company as a manufacturer after such time,
the Company's business, financial condition and results of operations could be
materially and adversely affected.
Risks Associated with Manufacturing
The Company's results of operations are dependent upon the continued operation
of its manufacturing facility in Woburn, Massachusetts. The operation of
biomedical manufacturing plants involves many risks, including the breakdown,
failure or substandard performance of equipment, natural and other disasters,
and the need to comply with the requirements of directives of government
agencies, including the FDA. In addition, the Company relies on a single
supplier for syringes and a small number of suppliers for a number of other
materials required for the manufacturing and delivery of its HA products.
Furthermore, manufacturing processes and research and development efforts of
the Company involve animals and products derived from animals. The utilization
of animals in research and development and product commercialization is
subject to increasing focus by animal rights activists. The activities of
animal rights groups and other organizations that have protested animal based
research and development programs or boycotted the products resulting from such
programs could cause an interruption in the Company's manufacturing processes
and research and development efforts. The occurrence of material operational
problems, including but not limited to the events described above, could
have a material adverse effect on the Company's business, financial
condition and results of operations during the period of such operational
difficulties.
No Assurance of Ability to Manage Growth
The Company's future success depends on substantial growth in product sales.
There can be no assurance that such growth can be achieved or, if achieved, can
be sustained. There can be no assurance that if substantial growth in product
sales and the demand for the Company's products is achieved, the Company
will be able to (i) develop the necessary manufacturing capabilities,
(ii) obtain the assistance of additional marketing partners, (iii) attract,
retain and integrate the required key personnel, or (iv) implement the
financial, accounting and management systems needed to manage growing demand
for its products, should it occur. Failure of the Company to successfully
manage future growth could have a material adverse effect on the Company's
business, financial condition and results of operations.
<PAGE>
Third Party Reimbursement and Health Care Cost Containment Initiatives
In the U.S. and other markets, health care providers, such as hospitals and
physicians, that purchase health care products, such as the Company's products,
generally rely on third party payors, including Medicare, Medicaid and other
health insurance and managed care plans, to reimburse all or part of the cost
of the health care product. Reimbursement by a third party payor may depend
on a number of factors, including the payor's determination that the use of
the Company's products are clinically useful and cost-effective, medically
necessary and not experimental or investigational. Since reimbursement approval
is required from each payor individually, seeking such approvals can be a time
consuming and costly process which, in the future, could require the Company
or its marketing partners to provide supporting scientific, clinical and
cost-effectiveness data for the use of the Company's products to each payor
separately. Significant uncertainty exists as to the reimbursement status of
newly approved health care products, and third party payors are increasingly
attempting to contain the costs of health care products and services by
limiting both coverage and the level of reimbursement for new therapeutic
products and by refusing in some cases to provide coverage for uses of
approved products for disease indications for which the FDA has not granted
marketing approval. In addition, Congress and certain state legislatures have
considered reforms that may affect current reimbursement practices, including
controls on health care spending through limitations on the growth of Medicare
and Medicaid spending. There can be no assurance that third party
reimbursement coverage will be available or adequate for any products or
services developed by the Company. Outside the U.S., the success of the
Company's products is also dependent in part upon the availability of
reimbursement and health care payment systems. Lack of adequate coverage and
reimbursement provided by government and other third party payors for the
Company's products and services could have a material adverse effect on the
Company's business, financial condition and results of operations.
Need for Additional Funds; Liquidity
The Company's future capital requirements and the adequacy of available
funds will depend on numerous factors, including market acceptance of its
existing and future products, the successful commercialization of products
in development, progress in its product development efforts, the magnitude
and scope of such efforts, progress with preclinical studies, clinical
trials and product clearances by the FDA and other agencies, the cost and
timing of its efforts to expand its manufacturing capabilities, the cost of
filing, prosecuting, defending and enforcing patent claims and other
intellectual property rights, competing technological and market
developments, and the development of strategic alliances for the marketing
of certain of its products. To the extent that funds generated from the
Company's operations, together with the Company's existing capital resources
and the net proceeds of this offering are insufficient to meet future
requirements, the Company will be required to obtain additional funds
through equity or debt financings, strategic alliances with corporate partners
and others, or through other sources. The terms of any future equity
financings may be dilutive to the Company's stockholders and the terms of
any debt financings may contain restrictive covenants which limit the
Company's ability to pursue certain courses of action. The ability of
the Company to obtain financing is dependent on the status of the Company's
future business prospects as well as conditions prevailing in the relevant
capital markets. No assurance can be given that any additional financing
will be made available to the Company or will be available on acceptable
terms should such a need arise.
Exposure to Product Liability Claims
The testing, marketing and sale of human health care products entail an
inherent risk of allegations of product liability, and there can be no
assurance that substantial product liability claims will not be asserted
against the Company. Although the Company has not received any material
product liability claims to date and has a $1 million insurance policy to
cover such claims should they arise, there can be no assurance that material
claims will not arise in the future or that the Company's insurance will be
adequate to cover all situations. Moreover, there can be no assurance that
such insurance, or additional insurance, if required, will be available in
the future or, if available, will be available on commercially reasonable
terms. Any product liability claim, if successful, could have a material
adverse effect on the Company's business, financial condition and results of
operations.
Dependence Upon Key Personnel
The Company is highly dependent on the members of its management and
scientific staff, the loss of one or more of whom could have a material
adverse effect on the Company. In addition, the Company believes that its
future success will depend in large part upon its ability to attract and
retain highly skilled, scientific, managerial and manufacturing personnel.
The Company faces significant competition for such personnel from other
companies, research and academic institutions, government entities and other
organizations. There can be no assurance that the Company will be successful
in hiring or retaining the personnel it requires. The failure to hire and
retain such personnel could have a material adverse effect on the Company's
business, financial condition and results of operations.
<PAGE>
Uncertainty of Estimates
To assist investors in evaluating the Company, this Prospectus (including
the documents incorporated herein by reference) contains certain estimates of
market size and market share for the Company's and its competitors' HA
products. These estimates have been derived by the Company on the basis of
its analysis of industry reports, press releases and market research
reports compiled by independent third-party sources which the Company
believes to be reliable. However, all such estimates are inherently subject
to uncertainties, and the Company is unable to determine with a degree of
certainty the size of the market for certain HA based products and the market
share held by its products.
This Prospectus also reflects the Company's estimates regarding future
regulatory submission dates. Regulatory submissions can be delayed, or plans
to submit applications for product approvals can be canceled, for a number
of reasons, including the receipt of unfavorable preclinical or clinical
study results, changes in regulations, adoption of new or unanticipated
enforcement of existing regulations, technological developments and
competitive developments. Accordingly, no assurances can be given that the
Company's anticipated submissions will be made on their target dates, or
at all. Delays in such submissions could have a material adverse effect on
the Company's business, financial condition and results of operations.
Environmental Regulation
The Company is subject to a variety of local, state and federal government
regulations relating to the storage, discharge, handling, emission, generation,
manufacture and disposal of toxic, or other hazardous substances used in the
manufacture of the Company's products. Any failure by the Company to control
the use, disposal, removal or storage of hazardous chemicals or toxic
substances could subject the Company to significant liabilities, which could
have a material adverse effect on the Company's business, financial
condition and results of operations.
Risks Relating to International Operations
Approximately 10% of the Company's product sales during 1997 were generated
in international markets through marketing partners. The Company's
representatives, agents and distributors which sell products in international
markets are subject to the laws and regulations of the foreign jurisdictions
in which they operate and in which the Company's products are sold. A number
of risks are inherent in international sales and operations. For example,
the volume of international sales may be limited by the imposition of
government controls, export license requirements, political instability,
trade restrictions, changes in tariffs, difficulties in managing
international operations, import restrictions and fluctuations in foreign
currency exchange rates. Such changes in the volume of sales may have an
adverse effect on the Company's business, financial condition and results of
operations.
Potential Volatility of Stock Price; No Control Over Market Making
The market price of shares of the Company's Common Stock may be highly
volatile. Factors such as announcements of new commercial products or
technological innovations by the Company or its competitors, disclosure of
results of clinical testing or regulatory proceedings, governmental
regulation and approvals, developments in patent or other proprietary rights,
public concern as to the safety of products developed by the Company and
general market conditions may have a significant effect on the market price
of the Company's Common Stock. The trading price of the Company's Common
Stock could be subject to wide fluctuations in response to quarter-to-quarter
variations in the Company's operating results, material announcements by the
Company or its competitors, governmental regulatory action, conditions in
the health care industry generally or in the medical products industry
specifically, or other events or factors, many of which are beyond the
Company's control. In addition, the stock market has experienced extreme
price and volume fluctuations which have particularly affected the market
prices of many medical products companies and which often have been
unrelated to the operating performance of such companies. The Company's
operating results in future quarters may be below the expectations of
equity research analysts and investors. In such event, the price of the
Common Stock would likely decline, perhaps substantially.
<PAGE>
No person is under any obligation to make a market in the Common Stock or
publish research reports on the Company, and any person making a market in
the Common Stock or publishing research reports on the Company may
discontinue market making or publishing such reports at any time without
notice. There can be no assurance that an active public market in the
Common Stock will develop or, if developed, will be sustained.
Lack of Payment of Dividends on Common Stock
The Company has never paid cash dividends on its Common Stock and does
not anticipate paying such dividends in the foreseeable future. The Company
currently intends to retain any future earnings for use in the Company's
business.
Possible Adverse Effect of Certain Anti-Takeover Provisions
Certain provisions of the Company's Restated Articles of Organization and
Amended and Restated By-laws could have the effect of discouraging a third
party from pursuing a non-negotiated takeover of the Company and preventing
certain changes in control. These provisions include a classified Board of
Directors, advance notice to the Board of Directors of stockholder proposals,
limitations on the ability of stockholders to remove directors and to call
stockholder meetings, the provision that vacancies on the Board of
Directors be filled by a majority of the remaining directors, the ability
of the Board of Directors to issue, without further stockholder approval,
preferred stock with rights and privileges which could be senior to the
Common Stock and the ability of the Board of Directors to adopt a
shareholder rights plan without seeking stockholder approval. The
Company also is subject to Chapter 110F of the Massachusetts General Laws
which, subject to certain exceptions, prohibits a Massachusetts corporation
from engaging in any of a broad range of business combinations with any
"interested stockholder" for a period of three years following the date
that such stockholder became an interested stockholder. These provisions
could discourage a third party from pursuing a takeover of the Company at
a price considered attractive by many stockholders, since such provisions
could have the effect of preventing or delaying a potential acquiror from
acquiring control of the Company and its Board of Directors.
<PAGE>
USE OF PROCEEDS
The Company received proceeds in the amount of $668,136 upon exercise of the
Warrants. Such proceeds will be added to the Company's working capital and
used for general corporate purposes. The Company will not otherwise receive
any of the proceeds from the sale of Common Stock offered hereby.
SELLING STOCKHOLDERS
The following table provides the name of and the number of Shares offered
for sale by the Selling Stockholder in the Offering. Since the Selling
Stockholder may sell all, some or none of their Shares, no estimate can be
made of the number or percentage of Shares that the Selling Stockholder will
own upon completion of the Offering. Assuming that all of the Shares
offered hereby are sold, the Selling Stockholder will not own more than 1%
of the outstanding shares of the Company's Common Stock after the Offering.
The Shares offered by this Prospectus may be offered from time to time
by the Selling Stockholder named below.
<TABLE>
<CAPTION>
Shares Owned as of Shares Offered
Name February 4, 1998 Hereby
<S> <C> <C>
Leerink, Swann, Garrity,
Sollami Yaffe & Wynn, Inc. 203,700 203,700
______________________
</TABLE>
Leerink, Swann, Garrity, Sollami, Yaffe & Wynn, Inc. (the "Placement
Agent" or "Selling Stockholder") acted as placement agent in connection with
a private placement transaction to accredited investors. In consideration
of its services, the Company paid the Placement Agent a fee of 8% of the
gross purchase price for the shares and, in addition, granted to the
Placement Agent warrants to purchase 146,664 shares of the Company's
Common Stock exercisable at $3.00 per share and warrants to purchase
57,036 shares of Common Stock exercisable at $4.00 per share (collectively,
the "Warrants"). Eric Swann, a principal of the Placement Agent, is the
adult son of the Chairman of the Board of Anika.
The Shares which are offered for sale by the Selling Stockholder were
acquired upon the exercise of the Warrants. In connection with the issuance
of the Warrants, the Company agreed to register the Shares to be received
upon exercise of the Warrants and to use its reasonable efforts to file a
registration statement with the Commission registering such Shares. See
"Plan of Distribution."
The Selling Stockholder represented in the Warrant Agreement pursuant to
which it was granted the right to purchase shares of the Company's Common
Stock, that it was purchasing the Shares from the Company without any present
intention of affecting a distribution of the Shares. In recognition of
the fact, however, that investors may want to be able to sell their
Shares when they consider appropriate, and in accordance with its agreement
in the Stock Purchase Agreement dated February 29, 1996, and that certain
Letter Agreement dated August 27, 1997, the Company has filed with the
Commission a registration statement on Form S-3 (of which this Prospectus
is a part) with respect to the sale of the Shares by the Selling Stockholder
from time to time. The Company will prepare and file such amendments
and supplements to the registration statement as may be necessary to keep
it effective for a period of (90) days.
<PAGE>
PLAN OF DISTRIBUTION
The Shares offered hereby may be sold from time to time by the Selling
Stockholder on NASDAQ on terms to be determined at the times of such sales.
The Selling Stockholder may also make private sales directly or through a
broker or brokers. Alternatively, the Selling Stockholder may from time to
time offer Shares offered hereby to or through underwriters, dealers or
agents, who may receive consideration in the form of discounts and commissions;
such compensation, which may be in excess of ordinary brokerage commissions,
may be paid by the Selling Stockholder and/or the purchasers of the Shares
offered hereby for whom such underwriters, dealers or agents may act. The
Selling Stockholder and any dealers or agents that participate in the
distribution of the Shares offered hereby may be deemed to be
"underwriters" as defined in the Securities Act and any profit on the sale
of such Shares offered hereby by them and any discounts, commissions or
concessions received by any such dealers or agents might be deemed to be
underwriting discounts and commissions under the Securities Act. The
aggregate proceeds to the Selling Stockholder from sales of the Shares
offered by the Selling Stockholder hereby will be the purchase price of
such Shares less any broker's commissions required to be paid by such
Selling Stockholder.
The Shares offered hereby may be sold from time to time in one or more
transactions at a fixed offering price, which may be changed, or at varying
prices determined at the time of sale or at negotiated prices.
In order to comply with the securities laws of certain states, if
applicable, the Shares offered hereby will be sold by the Selling Stockholder
in such jurisdictions only through registered or licensed brokers or dealers.
In addition, in certain states Shares may not be sold unless they have been
registered or qualified for sale in the applicable state or an exemption
from the registration or qualification requirement is available and is
complied with.
Under applicable rules and regulations under the Exchange Act, any person
engaged in the distribution of the Shares offered hereby may not
simultaneously engage in market making activities with respect to the
Shares for a period beginning on the later of five business days prior to
the determination of the offering price for the Shares or such time that
such person becomes a participant in the distribution. In addition, and
without limiting the foregoing, the Selling Stockholder will be subject to
applicable provisions of the Exchange Act and the rules and regulations
thereunder, including, without limitation, Regulation M, the provisions of
which may limit the timing of purchases and sales of Shares by the Selling
Stockholder.
The Company will pay the expenses incurred by the Company in connection
with the registration with the Commission of the Shares offered hereby (other
than underwriting discounts and selling commissions, any applicable transfer
taxes and the fees and expenses of counsel or other advisors to the
Selling Stockholder).
LEGAL MATTERS
The validity of the issuance of the Shares offered hereby will be passed
upon for the Company by Goodwin, Procter & Hoar LLP, Boston, Massachusetts.
As of February 6, 1998, Richard E. Floor, whose professional corporation is a
partner in the firm of Goodwin, Procter & Hoar LLP, beneficially owned
28,390 shares of Common Stock.
EXPERTS
The financial statements and schedules of Anika Therapeutics, Inc. as of
and for the years ended August 31, 1996 and August 31, 1995, have been
incorporated by reference herein and in the registration statement in
reliance upon the report of KPMG Peat Marwick LLP, independent certified
public accountants, incorporated by reference herein, and upon the authority
of said firm as experts in auditing and accounting.
<PAGE>
No person has been authorized in connection with
the offering made hereby to give any information or to
make any representation not contained in this
Prospectus and, if given or made, such information or
representation must not be relied upon as having been
authorized by the Company, the Selling Stockholder or
any other person. This Prospectus does not constitute
an offer to sell or a solicitation of an offer to buy any
of the Shares offered hereby to any person or by
anyone in any jurisdiction in which it is unlawful to
make such offer or solicitation. Neither the delivery
of this Prospectus nor any sale made hereunder shall,
under any circumstances, create any implication that
the information contained herein is correct as of any
date subsequent to the date hereof.
<TABLE>
<CAPTION>
TABLE OF CONTENTS
Page
<S> <C>
Available Information. . . 2
Incorporation of Certain
Documents by Reference . . 2
Risk Factors . . 4-12
The Company. . . 3
Use of Proceeds. . . 13
Selling Stockholders . . 13
Plan of Distribution . . 13-14
Legal Matters. . . 14
Experts. . . 14
____________________
<PAGE>
203,700 Shares
Anika Therapeutics,
Inc.
Common Stock
PROSPECTUS
February 12, 1998
<PAGE>
PART II. INFORMATION NOT REQUIRED IN PROSPECTUS
Item 14. Other Expenses of Issuance and Distribution.
The expenses in connection with the issuance and distribution of the
Shares being registered are set forth in the following table (all amounts
except the registration fee are estimated):
</TABLE>
<TABLE>
<CAPTION>
<S> <C>
Registration fee $ 479
Legal fees and expenses 12,000
Miscellaneous 3,000
-------
Total $15,479
=======
</TABLE>
All expenses referenced above will be borne by the Company.
Item 15. Indemnification of Directors and Officers.
The Company is a Massachusetts corporation. Reference is made to Chapter
156B, Section 13 of the Massachusetts Business Corporation Law (the "MBCL"),
which enables a corporation in its original articles of organization or an
amendment thereto to eliminate or limit the personal liability of a director
for monetary damages for violations of the director's fiduciary duty, except
(i) for any breach of the director's duty of loyalty to the corporation or
its stockholders, (ii) for acts or omissions not in good faith or which
involve intentional misconduct or a knowing violation of law, (iii) pursuant
to Sections 61 and 62 of the MBCL (providing for liability of directors for
authorizing illegal distributions and for making loans to directors, officers
and certain shareholders) or (iv) for any transaction from which a director
derived an improper personal benefit.
Reference also is made to Chapter 156B, Section 67 of the MBCL, which
provides that a corporation may indemnify directors, officers, employees
and other agents and persons who serve at its request as directors, officers,
employees or other agents of another organization or who serve at its request
in any capacity with respect to any employee benefit plan, to the extent
specified or authorized by the articles of organization, a by-law adopted
by the stockholders or a vote adopted by the holders of a majority of the
shares of stock entitled to vote on the election of directors. Such
indemnification may include payment by the corporation of expenses incurred
in defending a civil or criminal action or proceeding in advance of the final
disposition of such action or proceeding, upon receipt of an undertaking by
the person indemnified to repay such payment if he shall be adjudicated to be
not entitled to indemnification under Section 67 which undertaking may be
accepted without reference to the financial ability of such person to make
repayment. Any such indemnification may be provided although the person to be
indemnified is no longer an officer, director, employee or agent of the
corporation or of such other organization or no longer serves with respect to
any such employee benefit plan. No indemnification shall be provided, however,
for any person with respect to any matter as to which he shall have been
adjudicated in any proceeding not to have acted in good faith in the
reasonable belief that his action was in the best interest of the
corporation or to the extent that such matter relates to service with respect
to any employee benefit plan, in the best interests of the participants or
beneficiaries of such employee benefit plan.
The Articles of Organization of the Company (see Exhibit 4.1) provide for
indemnification of the officers and directors of the Company to the full
extent permitted by applicable law.
The Company and its directors and officers currently carry liability
insurance.
<PAGE>
Item 16. Exhibits.
<TABLE>
<CAPTION>
Exhibit No. Description
<S> <C>
4.1 Restated Articles of Organization.(1)
4.2 Certificate of Vote of Directors Establishing a Series of a
Class of Stock.(2)
4.3 Form of Stock Purchase Agreement dated as of February 29, 1996
containing undertaking by the Company to register shares of
Common Stock.(3)
4.4 Warrant Agreement dated as of April 1, 1996 relating to 146,664
shares of Common Stock.(3)
4.5 Warrant Agreement dated as of April 1, 1996 relating to 57,036
shares of Common Stock.(3)
4.6 Letter Agreement dated as of August 27, 1997 between the Company
and Leerink, Swann, Garrity, Sollami, Yaffe & Wynn, Inc.(4)
5.1 Opinion of Goodwin, Procter & Hoar LLP as to the legality of the
Shares being registered.
23.1 Consent of Accountants.
23.2 Consent of Goodwin, Procter & Hoar LLP (included in Exhibit 5.1
hereto).
24.1 Powers of Attorney (included on signature page of Registration
Statement as filed).
___________________
(1) Incorporated by reference to Exhibit 3.1 to the Company's Registration
Statement on Form 10 as filed with the Commission on March 5, 1993.
(2) Incorporated by reference to Exhibit 3.1 to the Company's Form 10-Q/A
for the quarterly period ended May 31, 1995 as filed with the Commission on
July 29, 1995.
(3) Incrporated by reference to Exhibits to the Company's Registration
Statement on Form S-3 as filed with the Commission on April 18, 1996.
(4) Incorporated by reference to Exhibits to the Company's Registration
Statement on Form SB-2 as filed with the Commission on October 29, 1997.
</TABLE>
Item 17. Undertakings.
(a) The undersigned registrant hereby undertakes:
(1) To file, during any period in which offers or sales are
being made, a post-effective amendment to this registration
statement:
(i) To include any prospectus required by Section
10(a)(3) of the Securities Act;
(ii) To reflect in the prospectus any facts or events
arising after the effective date of the registration statement
(or the most recent post-effective amendment thereof) which,
individually or in the aggregate, represent a fundamental
change in the information set forth in the registration
statement; and
(iii) To include any material information with respect to
the plan of distribution not previously disclosed in the
registration statement or any material change to such
information in the registration statement;
provided, however, that paragraphs (a)(1)(i) and (a)(1)(ii) herein
do not apply if the information required to be included in a
post-effective amendment by those paragraphs is contained in
periodic reports filed by the undersigned registrant pursuant to
Section 13 or Section 15(d) of the Exchange Act that are
incorporated by reference in the registration statement;
(2) That, for the purpose of determining any liability under
the Securities Act, each such post-effective amendment shall be
deemed to be a new registration statement relating to the Shares
offered therein, and the offering of such Shares at that time
shall be deemed to be the initial bona fide offering thereof; and
(3) To remove from registration by means of a post-effective
amendment any of the Shares being registered which remain unsold at
the termination of the offering.
<PAGE>
(b) The registrant hereby undertakes that, for purposes of determining
any liability under the Securities Act of 1933, each filing of the
registrant's annual report pursuant to Section 13(a) or 15(d) of the
Securities Exchange Act of 1934 that is incorporated by reference in
the Registration Statement shall be deemed to be a new registration
statement relating to the Shares offered therein, and the offering of
such Shares at that time shall be deemed to be the initial bona fide
offering thereof.
(c) Insofar as indemnification for liabilities arising under the
Securities Act of 1933 may be permitted to directors, officers and
controlling persons of the registrant pursuant to the provisions
described under Item 15 above, or otherwise, the registrant has
been advised that in the opinion of the Securities and Exchange
Commission such indemnification is against public policy as
expressed in the Securities Act of 1933 and is, therefore, unenforceable.
In the event that a claim for indemnification against such liabilities
(other than the payment by the registrant of expenses incurred or paid
by a director, officer, or controlling person of the registrant in
the successful defense of any action, suit or proceeding) is asserted
by such director, officer or controlling person in connection with
the Shares being registered, the registrant will, unless in the opinion
of its counsel the matter has been settled by controlling precedent,
submit to a court of appropriate jurisdiction the question whether
such indemnification by it is against public policy as expressed in
the Securities Act of 1933 and will be governed by the final
adjudication of such issue.
<PAGE>
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, Anika
Therapeutics, Inc. certifies that it has reasonable grounds to believe that
it meets all of the requirements for filing on Form S-3 and has duly caused
this Registration Statement to be signed on its behalf by the undersigned,
thereunto duly authorized, in Boston, Massachusetts, on the 12th day of
February, 1998.
Anika Therapeutics, Inc.
By:/s/ J. Melville Engle
---------------------
J. Melville Engle
President (Principal Executive Officer)
and Director
POWER OF ATTORNEY
KNOW ALL MEN BY THESE PRESENTS, that we, the undersigned officers and
directors of Anika Therapeutics, Inc. hereby constitute and appoint
J. Melville Engle and Sean F. Moran, and each of them singly, as our true
and lawful attorney-in-fact and agent, with full power to them, and each
of them singly, to sign for us and in our names in the capacities indicated
below, the Registration Statement filed herewith and any and all amendments
to said Registration Statement, and generally to do all such things in our
names and in our capacities as officers and directors to enable Anika
Therapeutics, Inc. to comply with the provisions of the Securities Act of
1933, as amended, and all requirements of the Securities and Exchange
Commission, hereby ratifying and confirming our signatures as they may
be signed by our said attorneys, or any of them, to said Registration
Statement and any and all amendments thereto.
Pursuant to the requirements of the Securities Act of 1933, as amended,
this Registration Statement has been signed by the following persons in
the capacities and on the dates indicated.
<TABLE>
<CAPTION>
Signature Capacity Date
<S> <C> <C>
/s/ David A. Swann Chairman of the Board February 12, 1998
--------------
David A. Swann
/s/ Joseph L. Bower Director February 12, 1998
---------------
Joseph L. Bower
/s/ Eugene A. Davidson Director February 12, 1998
------------------
Eugene A. Davidson
/s/ Jonathan D. Donaldson Director February 12, 1998
---------------------
Jonathan D. Donaldson
/s/ Samuel McKay Director February 12, 1998
------------
Samuel McKay
/s/ Harvey Sadow Director February 12, 1998
------------
Harvey Sadow
/s/ Steven E. Wheeler Director February 12, 1998
-----------------
Steven E. Wheeler
President (Principal Executive February 12, 1998
/s/J. Melville Engle Officer) and Director
-----------------
J. Melville Engle
Vice President of Finance and February 12, 1998
/s/ Sean F. Moran Treasurer (Principal Financial
------------- and Accounting Officer)
Sean F. Moran
<PAGE>
EXHIBIT INDEX
</TABLE>
<TABLE>
<CAPTION>
Exhibit No. Description
<S> <C>
4.1 Restated Articles of Organization.(1)
4.2 Certificate of Vote of Directors Establishing a Series of a Class
of Stock.(2)
4.3 Form of Stock Purchase Agreement dated as of February 29, 1996
containing undertaking by the Company to register shares of
Common Stock.(3)
4.4 Warrant Agreement dated as of April 1, 1996 relating to 146,664
shares of Common Stock.(3)
4.5 Warrant Agreement dated as of April 1, 1996 relating to 57,036
shares of Common Stock.(3)
4.6 Letter Agreement dated as of August 27, 1997 between the Company
and Leerink, Swann, Garrity, Sollami, Yaffe & Wynn, Inc.(4)
5.1 Opinion of Goodwin, Procter & Hoar LLP as to the legality of the
Shares being registered.
23.1 Consent of Accountants.
23.2 Consent of Goodwin, Procter & Hoar LLP (included in Exhibit
5.1 hereto).
24.1 Powers of Attorney (included on signature page of Registration
Statement as filed).
_______________________
(1) Incorporated by reference to Exhibit 3.1 to the Company's
Registration Statement on Form 10 as filed with the Commission on
March 5, 1993.
(2) Incorporated by reference to Exhibit 3.1 to the Company's Form
10-Q/A for the quarterly period ended May 31, 1995 as filed with
the Commission on July 29, 1995.
(3) Incorporated by reference to Exhibits to the Company's Registration
Statement on Form S-3 as filed with the Commission on April 18, 1996.
(4) Incorporated by reference to Exhibits to the Company's Registration
Statement on Form SB-2 as filed with the Commission on October 29,
1997.
</TABLE>
<PAGE>
Exhibit 5.1
February 12, 1998
Anika Therapeutics, Inc.
236 West Cummings Park
Woburn, MA 01801
Ladies and Gentlemen:
This opinion is delivered in our capacity as counsel to Anika Therapeutics,
Inc. (the "Company") in connection with the preparation and filing with the
Securities and Exchange Commission under the Securities Act of 1933, as
amended, of a Registration Statement on Form S-3 (the "Registration
Statement") relating to 203,700 shares of common stock, par value $.01 per
share, of the Company (the "Shares"), sold by the Company upon the exercise
of certain outstanding warrants (the "Warrants"). The Warrants were granted
by the Company pursuant to two Warrant Agreements (the "Warrant Agreements")
each dated as of April 1, 1996 between the Company and the warrantholder
named therein (the "Warrantholder").
As counsel for the Company, we have examined the Warrant Agreements, the
Company's Amended and Restated Articles of Organization and By-laws, each as
presently in effect, the Registration Statement and the exhibits thereto and
such records, certificates and other documents of the Company as we have
deemed necessary or appropriate for the purposes of this opinion. We have
also relied upon representations from the Company as to certain factual
matters relevant to this opinion.
We are attorneys admitted to practice in the Commonwealth of Massachusetts.
We express no opinion concerning the laws of any jurisdictions other than
the laws of the United States of America and the Commonwealth of
Massachusetts.
Based on the foregoing, we are of the opinion that the Shares are duly
authorized, legally issued, fully paid and non-assessable by the Company.
We hereby consent to being named as counsel to the Company in the
Registration Statement, to the references therein to our firm under the
caption "Legal Matters," and to the inclusion of this opinion as an
exhibit to the Registration Statement.
Very truly yours,
GOODWIN, PROCTER & HOAR LLP
<PAGE>
Exhibit 23.1
Independent Auditors' Consent
The Board of Directors
Anika Therapeutics, Inc.:
We consent to the use of our reports incorporated herein by reference and to
the reference to our firm under the heading "Experts" in the Prospectus.
KPMG Peat Marwick LLP
Boston, Massachusetts
February 12, 1998
