- $49.1 million of cash, cash
equivalents and investment securities as of December 31,
2017
- Successfully executed two funded collaborations in 2017 and
signed three new collaborations in 2018
- Early data generated from our research programs are showing
encouraging results for C1 technology
- Settlement with the last remaining defendant in
professional liability litigation lawsuit
- Successfully completed our $15 million share repurchase
program in February 2017 and announced a new $5 million program in
August 2017
- Fulfilled transitional services required under the DuPont
Transaction and received the escrowed funds of $7.4 million in July
2017
- Barry Buckland, Ph.D, a recognized industry thought leader
joined our board of directors
JUPITER, Fla., March 27, 2018 (GLOBE NEWSWIRE)
-- Dyadic International, Inc. (“Dyadic”) (OTCQX:DYAI), a global
biotechnology company focused on further improving and applying our
proprietary C1 gene expression platform to help speed up the
development and production of biologic vaccines and drugs at
flexible commercial scales, today announced its financial results
for the year ended December 31, 2017, and recent company
developments.
“We are pleased to report a strong finish for
2017, with the successful execution of two funded research
collaborations with big pharmaceutical companies and three new
research collaboration agreements already signed in 2018, including
the Israel Institute for Biological Research and Mitsubishi Tanabe
Pharma which we recently announced. These results demonstrate that
our business development efforts are bearing fruit. After we sold
our industrial enzyme business to DuPont for $75 million two years
ago, we developed a strategy to focus on applying our C1 gene
expression platform for use in the biopharmaceutical industry. Our
2017 accomplishments confirm that we are making good progress in
our transformational journey, delivering more promising scientific
data and ultimately driving shareholder value,” said Mark Emalfarb,
Chief Executive Officer.
BUSINESS HIGHLIGHTS OF 2017 AND RECENT
DEVELOPMENTS
- Successfully executed two funded confidential research
collaborations with two top tier pharmaceutical companies, and we
are in discussions with them about the next phases of
research.
- Early data generated from our research programs are showing
encouraging results for C1 technology.
- Fulfilled transitional services required under the DuPont
Transaction and received the escrowed funds of $7.4 million in July
2017.
- Continued our R&D efforts to engineer the C1 gene
expression platform for biopharmaceutical application. In this
regard, we:
- developed a new C1 base strain and expanded our molecular tool
box
- established an initial data set to demonstrate C1’s potential
to express monoclonal antibodies that are secreted, folded and bind
in similar manner as other commonly used cell host
technologies
- improved yields of biologically active antibodies and further
enhanced protein stability
- began glycoengineering of the C1 cell line to produce
non-immunogenic human-like glycoforms
- In June 2017, the Company entered into a multi-year strategic
research and development arrangement, including a potential
commercialization agreement, with Biotechnology Development for
Industry (“BDI”), a Spanish biotech company, to further advance
Dyadic’s proprietary C1 technology in the development of next
generation biological vaccines and drugs.
- Presented and hosted one-on-one meetings at numerous industry
conferences, including PEGS, BIO, Bioprocess International, and
many others.
- In early 2018, the Company entered into three research
collaborations, including Mitsubishi Tanabe Pharma Corp. and the
Israel Institute for Biological Research.
- Added Barry Buckland, Ph.D. a recognized industry thought
leader to our board in January 2018.
- Thomas Dubinski, the Company’s Chief Financial Officer, will
not be returning from his previously announced medical leave of
absence. Ping Rawson, the Company’s Director of Financial
Reporting, was promoted to Chief Accounting Officer on March 14,
2018 and will serve as the Company’s principal financial officer
and assume responsibility for finance, tax and treasury.
FINANCIAL RESULTS FOR THE YEAR ENDED
DECEMBER 31, 2017
At December 31, 2017, cash, cash equivalents and
restricted cash were $5.8 million compared to $14.3 million at
December 31, 2016. The carrying value of investment grade
securities, including accrued interest as of December 31, 2017
was $43.3 million compared to $43.6 million at December 31,
2016.
In April 2017, the Company settled its
professional liability litigation and received from the last
remaining defendant law firm Greenberg Traurig, LLP, and Greenberg
Traurig, P.A., a settlement payment in the amount of $4.4 million,
net of legal fees and other expenses.
In July 2017, the Company received $7.4 million
of cash held in escrow in connection with the previously announced
DuPont Transaction.
In February 2017, the Company successfully
completed its 2016 Stock Repurchase Program. In August 2017, the
Board of Directors authorized a new 2017 Stock Repurchase Program
to repurchase up to $5 million of Dyadic’s common stock.
As of December 31, 2017, the Company had
28.3 million common shares outstanding, after purchased 381,607
shares at a weighted average price of $1.41 per share in open
market transactions under this new stock repurchase program.
Subsequent to December 31, 2017, the Company purchased 267,000
additional shares at a weighted average price of $1.40 per
share.
Net loss for the year ended December 31,
2017 was $2.1 million, or $(0.07) per basic and diluted share,
compared to a net loss of $3.6 million, or $(0.10) per basic and
diluted share for the prior year.
Research and development revenue for the year
ended December 31, 2017 increased to $758,000 compared to
$593,000 for the prior year. The cost of research and development
revenue for the year ended December 31, 2017 increased to
$680,000 compared to $516,000 for the prior year. The increase in
research and development revenue, and costs of research and
development revenue reflect the activities of the ZAPI project and
two confidential biopharmaceutical research collaborations started
in December 2016, and June 2017, respectively.
For the year ended December 31, 2017, the
Company recorded a $221,000 provision for contract losses compared
to $437,000 for the prior year. The additional loss recorded in
2017 reflects the increase in total estimated research costs due to
the Company’s extended involvement in the ZAPI program. The
reported loss will be charged to the statement of operations and
offset the cost of research revenue over the term of the
contract.
Research and development expenses for the year
ended December 31, 2017, increased to $1,765,000 compared to
$886,000 for the year ended December 31, 2016. The increase
principally reflects the costs associated with ongoing internally
funded research and previously announced research projects with
third-party contract research organizations.
Research and development expenses - related
party, for the year ended December 31, 2017, increased to
$438,000 compared to $0 for the year ended December 31, 2016.
The increase reflects the research and development costs related to
the Company’s R&D agreements with BDI.
General and administrative expenses for the year
ended December 31, 2017 increased to $5,030,000 compared to
$4,562,000 for the prior year. The change principally reflects
increase in new employment agreements for executives of $312,000,
business development costs of $228,000, financial reporting costs
of $93,000, and other of $8,000, offset by a reduction in legal and
litigation costs of $118,000 and board compensation costs of
$55,000.
The Company’s foreign currency exchange gain,
for the year ended December 31, 2017 was $249,000 compared to a
loss of $147,000 for the prior year. The change represents the
strengthening of the Euro in comparison to U.S.
dollar.
Interest income for the year ended December 31,
2017 increased to $566,000 compared to $485,000 for the prior year.
The increase in interest income reflects returns earned on the
Company’s investment grade debt securities, which are classified as
held-to-maturity.
CONFERENCE CALL INFORMATION
Dyadic management will host a conference call
today, Tuesday, March 27, 2018 at 5:00 p.m.
to discuss the financial results for the year ended
December 31, 2017. In order to participate in the conference
call, please dial 888-437-9445 for U.S./Canada callers and +
719-325-4857 for International callers, using access code
5790217.
A replay of the conference call will be
available on Dyadic’s website (www.dyadic.com) within 24 hours
after the live event.
About Dyadic International,
Inc.
Dyadic International, Inc. is a global
biotechnology company which is developing what it believes will be
a potentially significant biopharmaceutical protein production
system based on the fungus Myceliophthora thermophila,
named C1. The C1 microorganism, which enables the development and
large scale manufacture of low cost proteins, has the potential to
be further developed into a safe and efficient expression system
that may help speed up the development, production and performance
of biologic vaccines and drugs at flexible commercial scales.
Dyadic is using the C1 technology and other technologies to conduct
research, development and commercial activities for the development
and manufacturing of human and animal vaccines, monoclonal
antibodies, biosimilars and/or biobetters, and other therapeutic
proteins. Dyadic pursues research and development collaborations,
licensing arrangements and other commercial opportunities with its
partners and collaborators to leverage the value and benefits of
these technologies in developing and manufacturing
biopharmaceuticals which these technologies help produce. In
particular, as the aging population grows in developed and
undeveloped countries, Dyadic believes the C1 technology may help
bring biologic drugs to market faster, in greater volumes, at lower
cost, and with new properties to drug developers and manufacturers
and, hopefully, improve access and cost to patients and the
healthcare system, but most importantly saving lives.
Please visit Dyadic’s website at
www.dyadic.com for additional information, including details
regarding Dyadic’s plans for its biopharmaceutical business.
Dyadic trades on the OTCQX tier of the OTC
marketplace. Investors can find real-time quotes, market
information and financial reports for Dyadic in the Company’s
annual and quarterly reports which are filed with the OTC markets.
Please visit the OTC markets website at
www.otcmarkets.com/stock/DYAI/quote.
Safe Harbor Regarding Forward-Looking
Statements
This press release contains forward-looking
statements. All statements other than statements of historical fact
are forward-looking statements, which are often indicated by terms
such as “anticipate,” “believe,” “could,” “estimate,” “expect,”
“goal,” “intend,” “look forward to,” “may,” “plan,” “potential,”
“predict,” “project,” “should,” “will,” “would” and similar
expressions. Forward-looking statements are based on management’s
beliefs and assumptions and on information available to management
only as of the date of this press release. These forward-looking
statements involve risks, uncertainties and other factors that
could cause Dyadic’s actual results, performance or achievements to
be materially different from any future results, performance or
achievements expressed or implied by such forward-looking
statements. Investors are urged to consider these factors carefully
in evaluating the forward-looking statements and are cautioned not
to place undue reliance on such forward-looking statements. Dyadic
expressly disclaims any intent or obligation to update or revise
any forward-looking statements to reflect actual results, any
changes in expectations or any change in events. Factors that could
cause results to differ materially include, but are not limited to:
(1) general economic, political and market conditions; (2) our
ability to carry out and implement our biopharmaceutical research
and business plans and strategic initiatives; (3) Dyadic’s ability
to retain and attract employees, consultants, directors and
advisors; (4) our ability to implement and successfully carry out
Dyadic’s and third parties research and development efforts; (5)
our ability to obtain new license and research agreements; (6) our
ability to maintain our existing access to, and/or expand access to
third party contract research organizations in order to carry out
our research projects for ourselves and third parties; (7)
competitive pressures and reliance on key customers and
collaborators; and (8) other factors discussed in Dyadic’s publicly
available filings, including information set forth under the
caption “Risk Factors” in our December 31, 2017 Annual Report filed
with OTC Markets on March 27, 2018. New risks
and uncertainties arise from time to time, and it is impossible for
us to predict these events or how they may affect us.
Contact:
Dyadic International, Inc.
Mark A. Emalfarb
Chief Executive Officer
Phone: 561-743-8333
Email: memalfarb@dyadic.com
DYADIC INTERNATIONAL, INC. AND
SUBSIDIARIES
CONSOLIDATED STATEMENTS OF
OPERATIONS
|
Years Ended December 31, |
|
2017 |
|
2016 |
Revenues: |
|
|
|
Research
and development revenue |
$ |
758,420
|
|
$ |
592,886
|
|
|
|
|
Costs and
expenses: |
|
|
|
Costs of
research and development revenue |
680,197
|
|
516,162
|
Provision
for contract losses |
220,715
|
|
436,916
|
Research
and development |
1,765,474
|
|
885,602
|
Research
and development - related party |
437,621
|
|
—
|
General
and administrative |
5,030,354
|
|
4,562,115
|
Foreign
currency exchange (gain) loss, net |
(249,059) |
|
147,338
|
Total costs and
expenses |
7,885,302
|
|
6,548,133
|
|
|
|
|
Loss from
operations |
(7,126,882) |
|
(5,955,247) |
|
|
|
|
Other
income: |
|
|
|
Settlement of litigation, net |
4,358,223
|
|
2,100,000
|
Interest
income, net |
566,146
|
|
484,581
|
Total other
income |
4,924,369
|
|
2,584,581
|
|
|
|
|
Loss before
income taxes |
(2,202,513) |
|
(3,370,666) |
|
|
|
|
(Benefit) provision for
income taxes |
(66,694) |
|
238,073
|
|
|
|
|
Net
loss |
$ |
(2,135,819) |
|
$ |
(3,608,739) |
|
|
|
|
Basic and diluted net
loss per common share |
$ |
(0.07) |
|
$ |
(0.10) |
|
|
|
|
Basic and diluted
weighted-average common shares outstanding |
28,917,961
|
|
36,538,444
|
|
|
|
|
|
|
Balance sheet
information: |
December 31, |
|
2017 |
|
2016 |
|
|
|
|
Cash and
cash equivalents |
$ |
5,786,348 |
|
$ |
6,889,357 |
Escrowed
funds from sale of assets |
— |
|
7,364,859 |
Investment securities, short-term and long-term and interest
receivable |
43,311,243 |
|
43,609,849 |
Prepaid
research and development (current and non-current) |
1,167,439 |
|
— |
Total
assets |
50,744,159 |
|
58,700,420 |
Accumulated deficit |
(27,351,357) |
|
(25,204,314) |
Stockholders’ equity |
$ |
49,975,264 |
|
$ |
57,690,183 |
|
|
|
|
*Condensed from audited
financial statements |
|
|
|
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