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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): February 15, 2024
HARROW,
INC.
(Exact
name of registrant as specified in its charter)
Delaware |
|
001-35814 |
|
45-0567010 |
(State
or other jurisdiction
of
incorporation) |
|
(Commission
File Number) |
|
(IRS
Employer
Identification No.) |
102
Woodmont Blvd., Suite 610 |
|
|
Nashville,
Tennessee |
|
37205 |
(Address
of principal executive offices) |
|
(Zip
Code) |
Registrant’s
telephone number, including area code: (615)
733-4730
Not
Applicable |
(Former
Name or Former Address, if Changed Since Last Report) |
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
on exchange on which registered |
Common
Stock, $0.001 par value per share |
|
HROW |
|
The
Nasdaq Stock Market LLC |
8.625%
Senior Notes due 2026 |
|
HROWL |
|
The
Nasdaq Stock Market LLC |
11.875%
Senior Notes due 2027 |
|
HROWM |
|
The
Nasdaq Stock Market LLC |
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:
☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
|
☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule
12b-2 of the Securities Act of 1934: Emerging growth company ☐
If
any emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item
8.01 Other Items.
On
February 15, 2024, Harrow, Inc. announced that it and some of its wholly-owned subsidiaries (together, the “Company”) had
entered into a licensing agreement (the “Agreement”) with Apotex Inc. (“Apotex”). Under the terms of the Agreement,
Apotex licensed from the Company exclusive rights and marketing authorizations of the following products in the Canadian market: VERKAZIA
(cyclosporine ophthalmic emulsion) 0.1%; and Cationorm PLUS. In addition, Apotex agreed to pursue regulatory approval in Canada for VEVYE
(cyclosporine ophthalmic solution) 0.1%; IHEEZO (chloroprocaine hydrochloride ophthalmic gel) 3%; and ZERVIATE (cetirizine ophthalmic
solution) 0.24%. In consideration for such rights, the Company will be eligible to receive certain
milestone payments based on manufacturing related events, regulatory approval and commercial activities along with royalties on net sales
of the products.
A
copy of the press release announcing the Agreement is filed as Exhibit 99 to this report.
Item
9.01 Financial Statements and Exhibits.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
|
HARROW,
INC. |
|
|
|
Dated:
February 15, 2024 |
By: |
/s/
Andrew R. Boll |
|
|
Andrew
R. Boll |
|
|
Chief
Financial Officer |
Exhibit
99
Harrow
Licenses Canadian Rights to Apotex
For Five Branded Ophthalmic Pharmaceutical Products
NASHVILLE,
Tenn. and TORONTO, Ontario, Canada (February 15, 2024) – Harrow, Inc. (Nasdaq: HROW), a leading U.S. eyecare pharmaceutical company,
and Apotex Inc. (“Apotex”), Canada’s largest pharmaceutical company, today jointly announced an exclusive out-licensing
agreement under which Apotex will market and distribute VERKAZIA® and over-the-counter (OTC) Cationorm®
PLUS in the Canadian market, and concurrently, pursue market approval in Canada for VEVYE®, IHEEZO®, and
ZERVIATE®.
“We
are pleased to enter the Canadian market through this partnership with Apotex, which has a proven track record of success serving Canadian
eyecare professionals and their patients,” said Mark L. Baum, Chairman and Chief Executive Officer of Harrow. “This exclusive
agreement fulfills our commitment to access and availability of these five important ophthalmic pharmaceutical products, and we look
forward to working closely with our partners at Apotex over the coming years as they seek approval for VEVYE, IHEEZO and ZERVIATE in
the Canadian market.”
“We
are excited to partner with Harrow to provide access to an innovative branded line of ophthalmic products that complement our existing
portfolio,” stated Allan Oberman, President and Chief Executive Officer of Apotex. “This alliance expands Apotex’s
product offering in Canada to include innovative patented pharmaceutical medicines, aligned with our ongoing strategic focus to further
expand our innovative branded pharmaceutical therapeutic areas of focus in becoming a Canadian-based global health company.”
“Adding
these products strengthens our therapeutic line and provides Canadian patients with valuable new treatment options,” adds Mike
Woolcock, Senior Vice President, Biosimilars & Specialty. “We look forward to collaborating with Harrow to expand this line
with VEVYE, IHEEZO, and ZERVIATE upon receiving market approval to improve the overall patient quality of life in this category.”
Under
the terms of the agreement, Apotex licensed exclusive rights and marketing authorizations of the following products in the Canadian market
from Harrow:
| ● | VERKAZIA
(cyclosporine ophthalmic emulsion) 0.1%, a calcineurin inhibitor immunosuppressant indicated
for the treatment of vernal keratoconjunctivitis (VKC) in children from four years of age
through adolescence. |
| ● | Cationorm
PLUS, an OTC, preservative-free emulsion for the treatment of dry eye symptoms and the treatment
of signs and symptoms of ocular allergy. |
And
for products, Apotex will pursue approval for in Canada:
| ● | VEVYE
(cyclosporine ophthalmic solution) 0.1%, a novel water-free vehicle (perfluorobutylpentane)
based on semifluorinated alkanes, indicated to treat the signs and symptoms of dry eye disease. |
| ● | IHEEZO
(chloroprocaine hydrochloride ophthalmic gel) 3%, a single-use, low-viscosity gel indicated
for ocular surface anesthesia. |
| ● | ZERVIATE
(cetirizine ophthalmic solution) 0.24%, a histamine-1 (H1) receptor antagonist indicated
for the treatment of ocular itching associated with allergic conjunctivitis. |
-MORE-
Harrow
Licenses Canadian Rights to Apotex For Five Branded Ophthalmic Pharmaceutical Products
Page
2
February
15, 2024
About
Apotex Inc.
Apotex
Inc. is a Canadian-based global health company that produces high-quality, affordable and complex medicines for patients around the world,
with a strategic focus on becoming a Pan-Canadian Health Champion. Apotex has an integrated portfolio of generic and innovative branded
pharmaceutical products for global markets. Apotex employs almost 7,000 people worldwide in manufacturing, R&D, and commercial operations.
Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, Apotex is comprised of
multiple divisions and affiliates, including Apotex Inc., focused on generic and specialty innovative medicines in Canada and internationally,
Apotex Corp., an affiliate of Apotex Inc. which markets and sells products in the United States, and Apobiologix, a division of Apotex
Inc. focused on biosimilar development. For more information, visit: www.apotex.com
About
Harrow
Harrow,
Inc. (Nasdaq: HROW) is a leading eyecare pharmaceutical company engaged in the discovery, development, and commercialization of innovative
ophthalmic pharmaceutical products for the U.S. market. Harrow helps U.S. eyecare professionals preserve the gift of sight by making
its comprehensive portfolio of prescription and non-prescription pharmaceutical products accessible and affordable to millions of Americans
each year. For more information about Harrow, please visit harrow.com.
Forward-Looking
Statements
This
press release contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act
of 1995. Any statements in this release that are not historical facts may be considered such “forward-looking statements.”
Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties which may
cause results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties
that could cause actual results to differ from those predicted include, among others, risks related to: our ability to successfully implement
our business plan and commercialize our products in a timely manner or at all, obtain necessary approvals for products in Canada, recruit
and retain qualified personnel, manage any growth we may experience and successfully realize the benefits of the licensing arrangements;
physician interest in and market acceptance of our products; competition from other pharmaceutical companies; general economic and business
conditions, including inflation and supply chain challenges; and regulatory and legal risks and uncertainties related to our operations
and the pharmaceutical business in general. These and additional risks and uncertainties are more fully described in Harrow’s filings
with the Securities and Exchange Commission (the “SEC”), including its Annual Report on Form 10-K and its Quarterly Reports
on Form 10-Q. Such documents may be read free of charge on the SEC’s web site at sec.gov. Undue reliance should not be placed
on forward-looking statements, which speak only as of the date they are made. Except as required by law, Harrow undertakes no obligation
to update any forward-looking statements to reflect new information, events, or circumstances after the date they are made, or to reflect
the occurrence of unanticipated events.
Contacts:
For
Harrow:
Investors |
|
Media |
Jamie
Webb |
|
Deb
Holliday |
Director
of Communications and Investor Relations |
|
Holliday
Communications, Inc. |
jwebb@harrowinc.com |
|
deb@hollidaycommunications.net |
615-733-4737 |
|
412-877-4519 |
|
|
|
For
Apotex: |
|
|
Media |
|
|
media@apotex.com |
|
|
-END-
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