Interim report for
Enzymatica AB (publ)
JANUARY- DECEMBER 2017
Strong growth and international breakthrough in 2017
Q4
-
Net sales reached SEK 19.1 (11.3) million.
-
Net profit after tax came in at SEK -5.6 (-17.6)
million.
-
Earnings per share, basic and diluted, were SEK
-0.06 (-0.19).
-
Cash and cash equivalents were SEK 10.9 (35.6)
million.
Significant events in Q4
-
Enzymatica presented the results of an in vitro
study demonstrating the ability of ColdZyme Mouth Spray to
deactivate four of our most common cold viruses.
-
Enzymatica published the results of a study of
preschool personnel showing that use of ColdZyme® reduced the
average absence due to illness by almost half, (45%), from 7.4 to
4.1 days.
-
Enzymatica published a complete article
reporting the results of the COLDPREV I study, in which the data
demonstrated a 99% reduction in viral load and a reduction in the
number of days absent due to sickness by more than half, 54%, from
6.5 to 3 days.
-
A new market survey presented that ColdZyme is
the most recommended cold product at Swedish pharmacies.
Full
year
-
Net sales increased to SEK 59.4 (36.5)
million.
-
Net profit after tax came in at SEK -31.4
(-45.0) million.
-
Earnings per share, basic and diluted, were SEK
-0.35 (-0.69).
-
International breakthrough for Enzymatica by the
agreement with the German pharmaceutical company STADA for sales of
ColdZyme® Mouth Spray in Germany, Belgium and Austria.
-
In a customer survey, 40% of customers stated
that they use ColdZyme preventively, and that if they should catch
a cold anyway, almost 80% state that they experience milder cold
symptoms or a shorter duration.
-
An extraordinary general meeting resolved on
October 25 to authorize the Board of Directors to implement
Employee Warrant Plan II and to carry out a directed issue of
warrants, as well as to approve the transfer of warrants.
Key figures for the Group |
|
|
|
|
(SEK million) |
Oct-Dec
2017 |
Oct-Dec
2016 |
Full year
2017 |
Full year
2016 |
Net
sales |
19.1 |
11.3 |
59.4 |
36.5 |
Gross
margin % |
72 |
56 |
61 |
61 |
Operating
profit/loss |
-4.7 |
-18.5 |
-30.2 |
-46.2 |
Cash flow
from operating activities |
1.9 |
-4.2 |
-22.5
|
-38.4 |
Average
number of employees |
21 |
22 |
21 |
22 |
CEO statement: We achieved several important
milestones in 2017
Enzymatica achieved several
important milestones in 2017. Our major international breakthrough
came from the agreement with the pharmaceutical company STADA, a
market leader in the cold segment in a number of major markets,
including Germany and the UK. Our sales growth was strong at 63%
during the year and ended at SEK 59.4 million, which can be
compared with SEK 36.5 million for 2016. In addition, we
substantially reduced the loss to SEK 30.2 million (loss: SEK 46.1
million). The fourth quarter was the 16th consecutive quarter that
we demonstrated sales growth compared with the previous years.
Sales in the Swedish market shows uninterrupted double-digit growth
over the full year, with a rolling 12-month market share in value
for ColdZyme of more than 5% in the cold segment. Enzymatica also
presented a number of clinical studies and market studies with
exciting results, and we filled several key positions following
strategic hiring campaigns.
Sales in Sweden, Denmark and Germany in particular
contributed to the increased sales during the quarter and the full
year. The continuous sales growth of ColdZyme on our home markets
indicates that our consumers experience clear benefit from the
product. ColdZyme was the brand, among the top ten products in the
cold segment in the Swedish market, that had the fastest growth in
value over the past year. ColdZyme passed Nezeril in sales value as
a brand. Sales in Denmark also surged after our advertising
campaigns and efforts of our own sales force.
Our agreement with the German pharmaceutical
company STADA is the result of years of work aimed at becoming an
attractive partner for international pharmaceutical
companies. We have upgraded our internal processes such as
our quality management and regulatory systems, and production. In
addition, enzyme production at our Icelandic subsidiary Zymetech
was upgraded during the year to be able to meet the demands of
continued sales growth and quality demand. Zymetech was acquired in
2016 to gain control of the enzyme patents and production, as well
as to strengthen our research expertise. In summary, we have become
a much more attractive partner that can offer patent protection for
enzyme-based products, and therefore exclusivity for our partners,
at the same time that advanced enzyme production and unique
know-how have created a technical platform that allows expansion
within new product areas. Signing a distribution
agreement with a major international pharmaceutical company is a
stamp of quality for our product and business, acknowledging
the results of our strategic efforts.
STADA's market investments during the second half
of the year produced results and the company is extremely satisfied
with the sales trend for ViruProtect®, which is STADA's co-brand
for ColdZyme. Since its launch last fall, ViruProtect has achieved
a market share on a level with Esberitox - a known cold product
that has been on the German market for many years. The sales trend
was also positive in Belgium and Austria, which are also covered by
our agreement with STADA.
We strengthened the documentation about ColdZyme
during the year. We published several clinical studies on preschool
staff and elite athletes. We announced several market and customer
surveys, and also presented the complete article for the COLDPREV I
study as well as an in-vitro study of ColdZyme. The results of
these studies show an unequivocal picture of ColdZyme's beneficial
effect on colds. The in-vitro study in particular was important
since it demonstrates ColdZyme's capacity to deactivate four of our
most common cold viruses by reducing the ability of the virus to
invade the cells.
In 2017 we also filled several key positions
including our Chief Commercial Officer, Chief Operating Officer and
Chief Financial Officer. The significant international experience
that they contribute is valuable and crucial for both our continued
expansion and in negotiations with international partners.
The trend in the fourth quarter followed the
pattern from previous quarters with continued growth at a very
strong 70%. STADA's follow-up order contributed to the robust
growth during the quarter. I am also satisfied that we had a
positive cash flow for the fourth quarter.
As I summarize the year, I would also like to
thank all of our employees and partners for their outstanding
efforts, which have taken our business to a new level.
I have great expectations for 2018. We will
continue to focus on sales, strengthened documentation of ColdZyme
and geographic expansion. Our goal is to increase sales and to
enter into at least one new distribution agreement for a key market
and continue our growth in "mature" markets like Sweden and
Denmark.
Fredrik Lindberg, CEO
Enzymatica at a glance
Enzymatica AB is a life science company whose business concept is
to develop medical devices based on barrier technology and marine
enzymes for self-care in major market segments. The Company
developed ColdZyme®, a unique mouth spray for fighting colds,
launched the product on about ten markets and since the launch in
2013 reached a position over the past winter as one of the
most-sold brands in Swedish pharmacies measured in SEK. Enzymatica
has its own sales organization in Scandinavia and collaborates with
a contract sales organization in the UK. Enzymatica also sells via
distributers in Spain, Greece, Finland, Iceland, Belgium, Germany
and Austria.
Our development focuses on products for upper
respiratory infections, dermatology and oral health. An enzyme
extracted from deep-sea cod is a key sub-component in product
development.
Enzymatica was founded in 2007, has its head
office in Lund and has been listed on the Nasdaq First North since
June 15, 2015.
ColdZyme is sold both in-house
and via distributors and partners in Sweden, Denmark, Norway,
Finland, the UK, Greece and Spain, and from fall 2017 under the
ViruProtect® brand in Belgium, Germany and Austria. An equivalent
product under the PreCold brand is sold in Iceland by the acquired
company Zymetech.
Q4 performance
During the fourth quarter the total cold category slipped -4.0% in
volume, while ColdZyme (20 and 7ml) increased sales in terms of
volume to consumers in the Swedish market by 4.4%, which was the
best performance in the top ten list of cold product brands during
the fourth quarter according to recent statistics from market
research firm Nielsen. In terms of sales volume, the 7 ml and 20 ml
packages are about equal. In 2017 sales of ColdZyme increased by
13.5% in value - the largest increase among the top ten cold
products in the market. This figure should also be compared with
growth for the entire cold segment in Sweden, which totaled 1.3%.
ColdZyme passed Nezeril in sales value as a brand in 2017. ColdZyme
increased its market share from 4.5% to 5.1% on a rolling 12-month
basis. During the fourth quarter Enzymatica carried out an
extensive marketing communication campaign that included television
advertising, cooperation with TV4's Idol, sponsorship of athletes
and "influencer marketing" aimed at various ColdZyme target
groups.
Robust sales growth in the Danish market also
continued during the fourth quarter. ColdZyme had a market share in
value of 3.75% during the fourth quarter and on an annual basis the
market share is 2.5%, which follows the trend previously seen in
Sweden. For 2017 ColdZyme sales increased by about 9% compared with
growth in the cold segment as a whole, which essentially stood
still at +0.5% for the full year in Denmark. Sales to consumers in
the Spanish market have begun to move, demonstrating strong growth
at +90% during the fourth quarter, albeit from previously modest
levels. Contacts with pharmacists and a digital and social media
campaign targeting consumers are important factors underlying the
increase in sales. Sales on other markets progressed according to
plan.
Sales, earnings and investments
Q4
Consolidated net sales for Q4 2017 came in at SEK 19.1 (11.3)
million - a 70% year-on-year increase. The majority of the
increase is attributable to STADA and to Swedish pharmacies.
The gross margin during the quarter was 72% (56%).
Enzymatica has experienced fluctuations in its gross margins
between individual quarters as a result of the distribution of
sales via its own organization or distributors, the product mix and
exchange rates.
Total operating expenses for the quarter amounted
to SEK 21.4 (25.2) million. The decrease in operating expenses
compared with Q4 2016 is primarily due to lower research and
development costs, consultant fees and marketing costs. No expenses
for development projects were capitalized during the year SEK 0
(0.8) million.
The consolidated operating loss was SEK -4.7
(-18.5) million.
Seasonal
variations
Cold products have a seasonal peak in the winter, while sales level
out in the summer months.
Year-end report
2017
Consolidated net sales in 2017 came in at SEK 59.4 (36.5) million -
a 63% year-on-year increase.
The gross margin for the period was 61% (61%).
Total operating expenses for the period were SEK
71 (69.7) million. Beginning with the Q3 report the entry for
capitalized development projects is included as part of research
and development costs. All comparative figures have been restated
in accordance with the above.
Enzymatica had no capitalized expenses for
development projects during the quarter - SEK 0 (7.6) million.
The consolidated operating loss was SEK -30.2
(-46.2) million.
Research and development
Strengthening the documentation for the ColdZyme cold spray is a
key part of Enzymatica's R&D activities. Total consolidated
research and development expenses amounted to SEK 14.5 (12.3)
million for the period January-December 2017.
In addition, work is progressing according to plan
to certify the company to ISO standard 13485, the quality
management system standard for medical devices.
Barrier technology with enzyme
from deep-sea fish
An enzyme from a deep-sea cod is a key sub-component in
Enzymatica's product development efforts for creating effective
products with barriers against viruses and bacteria. The enzyme,
which is called cold-adapted trypsin, is formed in the cod's
pancreas and becomes hyperactive when it comes into contact with
the warm skin and sinuses of humans. Together with glycerol, the
enzyme forms a temporary barrier on the skin or sinuses. The
barrier makes it more difficult for viruses and bacteria to locally
infect cells and cause diseases.
Significant events during the quarter
Enzymatica presented the results of an in vitro study showing the
ability of ColdZyme to deactivate four of our common cold
viruses.
Enzymatica published the results of a study of
preschool personnel showing that use of ColdZyme reduced the
average absence due to illness by almost half, (45%), from 7.4 to
4.1 days.
Enzymatica published a complete article reporting
the results of the COLDPREV I study, which showed a 99% reduction
in viral load and a reduction in the number of days absent due to
sickness by more than half, 54%.
A new market survey showed that ColdZyme Mouth
Spray is the most recommended cold product at Swedish
pharmacies.
In a customer survey, 40% of customers stated that
they use ColdZyme preventively, and if they should catch a cold
anyway, almost 80% state that they experience milder cold symptoms
or shorter duration.
An extraordinary general meeting resolved on
October 25 to authorize the Board of Directors to implement
Employee Warrant Plan II and to carry out a directed issue of
warrants, as well as to approve the transfer of warrants.
Funding
The Group's available funds at the end of the period totaled SEK
11.8 (37.2) million, of which SEK 10.9 (35.6) million were in cash
and cash equivalents and SEK 0.9 (1.6) million in unutilized credit
facilities. In addition to the above available funds, there is an
unutilized credit facility with a maximum amount of SEK 9.8 million
via factoring in the parent company.
In conjunction with Enzymatica's 2016 acquisition
of Zymetech, a partial payment in the form of the issuance of
options for Zymetech's principal shareholders to acquire 4,000,000
shares in Enzymatica at a subscription price of SEK 5 was included
in the agreement. The options mature on April 1, 2018. If the
option is exercised Enzymatica will have an injection of capital of
approximately SEK 20 million.
If the financial development will require capital
in excess of the above the company's management and board have
planned measures, which will ensure the financing for the coming 12
months.
Cash flow from operating activities for the year
totaled SEK -22.7 (-38.4) million. Cash flow from operating
activities for Q4 came in at SEK 1.7 (-4.2) million.
Total cash flow for the year amounted to SEK -24.7
(27.2) million.
Parent company
The parent company's sales for the full year reached SEK 55.8
(33.1) million. Profit/loss before tax came in at SEK -95.7 (-36.3)
million.
Parent company sales for Q4 came in at SEK 19.5
(9.7) million. Profit/loss before tax came in at SEK -72.7 (-14.7)
million.
The parent company's investments in property,
plant & equipment and intangible assets for the period totaled
SEK 0 (10.7) million and cash flow was SEK -21.3 (24.1)
million.
In the parent company, there is a write-down of
shares in subsidiaries of SEK 60 million. This is the result of
transfer of intellectual properties (patent and capitalized
development costs) from the subsidiary Zymetech to the parent
company Enzymatica. Since it is an internal transaction it has no
effect on the Group's balance sheet or income statement nor cash
flow.
Please see the consolidated figures for more
information.
Staff
The number of people employed by the group, converted to full-time
positions, was 21 (22) at the end of the period. The employees
included 10 (10) men and 11 (12) women.
Employee Warrant Plan and directed issue of
warrants
An Extraordinary General Meeting resolved on October 25 to
authorize the Board of Directors to implement an employee warrant
plan and adopted a resolution on the directed issue of warrants and
approval of the transfer of warrants. As a result of this decision
to implement a second plan, the 2017/2023 Employee Warrant Plan II,
the plan will be offered to certain employees of the company, other
key individuals, or other individuals who are affiliated with the
Company by contractual agreement and are engaged in the development
of the Company (referred to below as "employees"). The 2017/2023
Employee Warrant Plan II is essentially based on the 2017/2023
Employee Warrant Plan approved by the Annual General Meeting on
April 20, 2017 and the purpose for implementing the 2017/2023
Employee Warrant Plan II is to provide additional employees with
the opportunity to participate in the incentive plan on the same
terms. The Employee Warrant Plan has been offered on one or
more occasions to employees selected by the Board of Directors
between October 25 and December 25, 2017. Warrant holders will be
able to exercise allocated warrants for the period from May 1, 2021
through July 31, 2023. The 2017/2023 Employee Warrant Plan II also
includes information about vesting period and profit
requirements.
The 2017/2023 Employee Warrant Plan II includes
1,390,000 employee warrants. Each warrant entitles the holder to
acquire a new share in the company at an exercise price of SEK
4.22. In order to enable the Company to deliver shares under the
proposal for issuance of warrants to Company employees and to
ensure coverage of costs associated with the warrants, primarily
social security contributions, the Extraordinary General Meeting
resolved to carry out a directed issue of a maximum of 1,826,738
warrants to Enzymatica's wholly owned subsidiary Enzymatica Care
AB.
If all warrants related to the two outstanding
personnel option programs that have been issued are exercised, a
total of 4,915,108 shares will be issued, corresponding to a
dilution of approximately 5 percent of the Company's share capital
and votes after full dilution calculated on the number of shares
that will be added upon full exercise of all outstanding and
proposed warrants. Upon full exercise of the warrants for
subscription of new shares in Program 2017/2023 II, the share
capital will increase by SEK 73,069.55, and upon full exercise of
the warrants for subscription of new shares in Program 2017/2023 I,
the share capital will increase by SEK 123,534,85. If all warrants
are utilized for subscription in both Personnel Option Program
2017/2023 I & II, the share capital will increase by a total of
SEK 196 604,40. A total of 3,088,370 warrants have been issued in
connection with Personnel Option Program 2017/2023 I and a total of
1,826,738 warrants have been issued in connection with Personnel
Option Program 2017/2023 II.
The total number of personnel options allocated in
Personnel Option Program 2017/2023 I is 2,350,000. In Personnel
Option Program 2017/2023 II the total number of personnel options
amounts to 1,390,000. This means that a total of 3,740,000 of
personnel options have been granted in the two personnel option
programs. All personnel options granted in programs 2017/2023 I
& II have been allocated and accepted by employees as of
December 31, 2017.
For more information about the Employee Warrant
Plan and issuance and transfer of warrants, please see Enzymatica's
website under Investors/Corporate Governance/Annual General
Meeting/Extraordinary General Meeting.
Issuance of new shares
The Extraordinary General Meeting resolved as of October 25 to
expand the Board's existing authorization to issue new shares as
resolved at the 2017 Annual General Meeting of shareholders. In
addition to allowing the Company to acquire working capital and to
take advantage of future opportunities for obtaining long-term
strong owners and to further fund the Company's growth strategy,
the reason for deviating from shareholders' preferential rights is
also to enable the Company to acquire outstanding minority shares
in the subsidiary Zymetech ehf. through a non-cash issue.
Otherwise, the Annual General Meeting's authorization shall remain
unchanged.
Significant events after the end of the
period
No significant events occurred after the end of the period.
Nomination Committee appointed
In accordance with the principles for the Nomination Committee
adopted at the Annual General Meeting 2016, the Nomination
Committee for the next Annual General Meeting shall consist of
representatives of the four largest shareholders registered in the
register of shareholders held by Euroclear Sweden AB as of October
31 each year, together with the Chairman of the Board, who shall
also convene the Nomination Committee until its first meeting.
The four largest owners (appointed representative
in the Nomination Committee in parentheses) as of October 31, 2017,
were Abanico Invest AB (Håkan Roos), Protenus Ltd (Gudmundur
Palmason), Gadice ehf. (Ágústa Gudmundsdottir) and Roosgruppen AB
(Björn Algkvist), who together with the chairman of the board,
Bengt Baron, constitute the nomination committee for the 2018
Annual General Meeting. Håkan Roos has been appointed Chairman of
the Nomination Committee.
Other information
Group
Enzymatica AB (publ) (corporate identity no. 556719-9244), with its
head office in Lund, Sweden, is the parent company of the following
subsidiaries: Zymetech ehf (corporate identity no. 6406830589),
with its head office in Reykjavik, Iceland, Enzymatica Care AB
(corporate identity no. 556701-7495), with its head office in Lund,
Sweden, and Enzymatica North America Inc, (corporate identity no.
47-1030502), with its head office in Delaware, USA.
In December 2017 intellectual properties, mainly
patent and capitalized development costs, were transferred from the
subsidiary Zymetech to the parent company Enzymatica.
Accounting
policies
This interim report has been prepared in compliance with IAS 34
Interim Financial Reporting. The consolidated financial statements
have been prepared in compliance with the International Financial
Reporting Standards (IFRS) as adopted by the EU and the Swedish
Annual Accounts Act. The parent company's financial statements have
been prepared in compliance with the Swedish Annual Accounts Act
and the Swedish Financial Reporting Board's recommendation RFR 2
Accounting for Legal Entities. The recognition and measurement
policies as well as the bases of estimates and judgements applied
in the 2016 Annual Report have been applied in this interim report
as well. New or revised IFRS standards that came into force in 2017
did not have any material impact on the group.
New and amended standards applied from January 1,
2018
As of January 1, 2018, Enzymatica applies IFRS 9
Financial Instruments and IFRS 15 Revenue from Contracts with
Customers.
IFRS 9 regulates classification, measurement and
recognition of financial assets and liabilities. This standard
replaces IAS 39 Financial Instruments that regulates the
classification and measurement of financial instruments. A project
was conducted within Enzymatica on the basis of the parts of IFRS 9
deemed to be able to have an impact: classification, measurement
and documentation of financial liabilities and assets, as well as
analysis of the effects of the transition to a new model for
recognition of anticipated credit losses, known as the "expected
loss model." Based on this evaluation, the new standard will not
have any material impact on the Enzymatica Group's reporting. Given
the immaterial effects of the new standard, previous periods will
not be restated.
As of January 1, 2018, Enzymatica will apply IFRS
15 Revenue from Contracts with Customers, which comes into force
from that date. Enzymatica has elected to use the full
retrospective approach as transition method for implementation of
IFRS 15. The new standard includes a principle-based five-step
model for revenue recognition relating to customer contracts. The
basic principle is that revenue recognition should reflect
anticipated compensation in connection with performance of the
various promises in the contract with the customer. Revenue must
therefore reflect fulfillment of contractual obligations and
correspond with the compensation to which Enzymatica is entitled at
the time that control of goods and services is transferred to the
counterparty.
In 2017 Enzymatica evaluated the effects of the
new standard by identifying and analyzing the most significant
revenue streams within the Group. The outcome of the analysis is
that revenues will essentially be recognized at the same time as
under the current standard and application. Enzymatica has
therefore concluded that implementation of the IFRS will not have
any material impact on the Group's financial statements.
Segment
reporting
Enzymatica's business currently only spans a single operating
segment, Medical devices. Please see the income statement and
balance sheet for reporting on this operating segment.
Information
about risks and uncertainties
Enzymatica's business is exposed to several risks, both operational
and financial risks. The operational risks mainly comprise
uncertainty concerning product development, supplier agreements,
product liability and distribution. The financial risks primarily
consist of currency, interest, price, credit and liquidity risks.
For a more detailed description of the risks and uncertainties
Enzymatica faces, please see the risk and sensitivity analysis in
the 2016 Annual Report, pages 47-48.
Audit
This report was not reviewed by the Company's auditors.
2018 AGM
Enzymatica's 2018 Annual General Meeting will be held in Lund at
1:00 p.m. on April 26, at the Elite Hotel Ideon in Lund.
Shareholders who wish to have an item added to the agenda of the
AGM may submit a written request by email to:
louise.forssell@enzymatica.com or by regular mail to the following
address: Styrelsen, Enzymatica AB, Ideon Science Park, 223 70 Lund.
Requests must be received no later than seven weeks prior to the
AGM to be eligible for inclusion in the meeting notice and thus the
AGM agenda.
Upcoming financial
information
Interim report, Jan-March
2018 April 26,
2018
Annual General Meeting
2018
April 26, 2018
Interim report, Jan-June
2018 July 17,
2018
Interim report, Jan-Sep
2018
October 31, 2018
The interim reports and annual report are
available on Enzymatica's website www.enzymatica.se.
The Board of Directors and CEO hereby confirm that
this interim report provides a true and fair view of the parent
company's and group's business, financial position and results of
operations, and describes material risks and uncertainties faced by
the parent company and group companies.
Lund, Wednesday, February 14, 2018
Bengt
Baron
Board Chair |
Marianne
Dicander Alexandersson
Board Member |
Guðmundur
Pálmason
Board Member
|
|
|
|
Sigurgeir
Guðlaugsson
Board Member |
Mats
Andersson
Board Member |
Louise
Nicolin
Board Member
|
|
|
|
Fredrik Lindberg, CEO
For questions about this report, please
contact:
Fredrik Lindberg, CEO, Enzymatica AB
Tel: +46 (0)708-86 53 70 | Email:
fredrik.lindberg@enzymatica.com
Therese Filmersson, CFO, Enzymatica AB
Tel: +46 (0)708-40 72 24 | Email:
therese.filmersson@enzymatica.com
Publication
This information is information that Enzymatica is obliged to
make public pursuant to the EU Market Abuse Regulation. The
information was submitted for publication, through the agency of
the contact person set out above, at 08:00 CET on Wednesday,
February 14, 2018.
Street address
Enzymatica AB (publ) Corporate identity no.: 556719-9244
Mailing address: Ideon Science Park, 223 70 LUND Street address:
Scheelevägen 19, Ideon, Lund
Tel: +46 (0)46-286 31 00 | info@enzymatica.se |
www.enzymatica.se
Enzymatica is listed on the Nasdaq First North.
The Company is traded under the ticker symbol ENZY and ISIN code
SE0003943620.
Enzymatica's certified advisor is Erik Penser Bank.
Enzymatica Year-End Report
2017
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Enzymatica AB via Globenewswire
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