Item 9A. Controls and Procedures
ITEM
9A. CONTROLS AND PROCEDURES.
Disclosure
Controls and Procedures
Our
management, including our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls
and procedures as of August 31, 2020. Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer concluded
that our disclosure controls and procedures are effective.
31
Management’s
Annual Report on Internal Control over Financial Reporting
Our
management, under the supervision of our Chief Executive Officer and Chief Financial Officer, is responsible for establishing
and maintaining adequate internal control over our financial reporting, as defined in Rules 13a-15(f) and 15d-15(f) promulgated
under the Exchange Act. The Company’s internal control over financial reporting is defined as a process designed to provide
reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external
purposes in accordance with GAAP. Internal control over financial reporting includes policies and procedures that:
● pertain
to the maintenance of records that in reasonable detail accurately and fairly reflect
our transactions and asset dispositions;
● provide
reasonable assurance that transactions are recorded as necessary to permit the preparation
of our financial statements in accordance with GAAP, and that our receipts and expenditures
are being made only in accordance with authorizations of our management and directors;
and
● provide
reasonable assurance regarding the prevention or timely detection of unauthorized acquisition,
use or disposition of assets that could have a material effect on our financial statements.
Under
the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer,
we evaluated the effectiveness of our internal control over financial reporting as of August 31, 2020 based on the current framework
for Internal Control-Integrated Framework (2013) set forth by The Committee of Sponsoring Organizations of the Treadway Commission.
Based
on this evaluation, our management concluded that the Company’s internal control over financial reporting was effective
as of August 31, 2020 at a reasonable assurance level.
Changes
in Internal Control over Financial Reporting
There
were no changes in our internal control over financial reporting that occurred during the quarter ended August 31, 2020 that have
materially affected, or are reasonable likely to materially affect, our internal control over financial reporting.
ITEM
9B. OTHER INFORMATION.
Not
applicable.
32
PART
III
ITEM
10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE.
Set
forth below is certain information with respect to the individuals who are our directors and executive officers.
Name
Age
Position
Nadav Kidron
46
President, Chief Executive Officer and Director
Miriam Kidron
80
Chief Scientific Officer and Director
Avraham Gabay
35
Chief Financial Officer, Treasurer and Secretary
Joshua Hexter
50
Chief Operating & Business Officer
Aviad Friedman
49
Director
Arie Mayer
64
Director
Kevin Rakin
60
Chairman, Director
Leonard Sank
55
Director
Gao Xiaoming
58
Director
Dr.
Miriam Kidron is Mr. Nadav Kidron’s mother. There are no other directors or officers of the Company who are related by blood
or marriage.
33
Business
Experience
The
following is a brief account of the education and business experience during at least the past five years of each director and
our executive officers who are not also directors, indicating the principal occupation during that period, and the name and principal
business of the organization in which such occupation and employment were carried out.
Mr.
Nadav Kidron was appointed President, Chief Executive Officer and a director in March 2006.
He is also a director of Israel Advanced Technology Industries organization, and until 2016 was a director of Entera Bio Ltd.
In 2009, he was a fellow at the Merage Foundation for U.S.-Israel Trade Programs for executives in the life sciences field. From
2003 to 2006, he was the managing director of the Institute of Advanced Jewish Studies at Bar Ilan University. From 2001 to 2003,
he was a legal intern at Wine, Mishaiker & Ernstoff Law Offices in Jerusalem, Israel. Mr. Kidron holds an LL.B. and an International
MBA from Bar Ilan University, Israel, and is a member of the Israel Bar Association.
We
believe that Mr. Kidron’s qualifications to serve on our Board include his familiarity with the Company as its founder,
his experience in capital markets, as well as his knowledge and familiarity with corporate management.
Dr.
Miriam Kidron was appointed Chief Scientific Officer and a director in March 2006. Dr. Kidron
is a pharmacologist and a biochemist with a Ph.D. in biochemistry. From 1990 to 2007, Dr. Kidron was a senior researcher in the
Diabetes Unit at Hadassah University Hospital in Jerusalem, Israel. During 2003 and 2004, Dr. Kidron served as a consultant to
Emisphere Technologies Inc., a company that specializes in developing broad-based proprietary drug delivery platforms. Dr. Kidron
was formerly a visiting professor at the Medical School at the University of Toronto (Canada), and is a member of the American,
European and Israeli Diabetes Associations. Dr. Kidron is a recipient of the Bern Schlanger Award.
We
believe that Dr. Kidron’s qualifications to serve on our Board include her expertise in the Company’s technology,
as it is based on her research, as well as her experience and relevant education in the fields of pharmacology and diabetes.
Mr.
Avraham Gabay was appointed Chief Financial Officer, Treasurer and Secretary effective June 2019. Prior
to his appointment, from 2015 until 2019, Mr. Gabay served as a corporate controller at Orcam Technologies Ltd., a company which
develops, manufactures and sells a wearable assistive technology device for people who are blind, visually impaired or have reading
or other disabilities. From 2014 to 2015, Mr. Gabay provided economic services in the advisory department of KPMG Israel, a certified
public accounting firm. From 2013 until 2014, Mr. Gabay worked in the tax department of the law firm, Gornitzky & Co. Mr.
Gabay holds a bachelor’s degree in law and accounting from Tel-Aviv University and is a certified public accountant in Israel
and a member of the Israeli Bar Association.
Mr.
Joshua Hexter was appointed Chief Operating & Business Officer , effective September 2019. Prior to his
appointment, Mr. Hexter served as Chief Business Officer at BrainsWay Ltd. (Nasdaq/TASE: BWAY) from 2018 to 2019, commercial stage
medical device company focused on the development and sale of non-invasive neuromodulation products. From 2013 to 2018, Mr. Hexter
served as Chief Operating Officer and VP Business Development of the Company and from 2007 to 2013, Mr. Hexter was a Director
or Executive Director of BioLineRx Ltd. (Nasdaq/TASE: BLRX), a biopharmaceutical development company dedicated to identifying,
in-licensing and developing innovative therapeutic candidates. Prior to his employment with BioLineRx, Mr. Hexter was a member
of the board of directors and Chief Executive Officer of Biosensor Systems Design, Inc., a company developing market-driven biosensors.
Mr. Hexter holds a bachelor’s degree from the University of Wisconsin and a master’s degree in management from Boston
University.
34
Mr.
Aviad Friedman became a director in August 2016. Mr. Friedman is an international businessman. Since 2007,
he has been Chief Executive Officer of Most Properties 1998 Ltd. Mr. Friedman was the first Director General of Israel’s
Ministry of Diaspora Affairs and served as personal advisor to Prime Minister Ariel Sharon from 2001 to 2005. Mr. Friedman served
as Chief Operating Officer of one of Israel’s premier newspapers, Ma’ariv from 2003 to 2007, and has more than 18
years of experience serving on boards of public and private companies including Maayan Ventures, Capital Point, Rosetta Green
Ltd. and Aerodrome Groupe Ltd. Mr. Friedman additionally served as an investor and consultant at Rhythmia Medical Inc. from 2007,
and was actively involved in the sale of the company to Boston Scientific in 2012. Mr. Friedman holds a bachelor’s degree
and master’s degree with honors in Public Administration from Bar-Ilan University.
We
believe that Mr. Friedman’s qualifications to serve on our Board include his experience in serving as a director of public
and private companies as well as his knowledge and familiarity with corporate finance.
Dr.
Arie Mayer became a director in December 2019. Dr. Mayer is currently the Managing Director and Chairman
of the Board of Merck Life Science Israel (formerly Sigma-Aldrich Israel Ltd.) and has held that position since January 2010.
Dr. Mayer has held various roles with Sigma-Aldrich Israel Ltd. since 1995 and was instrumental in introducing and developing
the Cell Culture and Molecular Biology business for Sigma Aldrich Israel Ltd. Dr. Mayer holds a Bachelor of Science degree in
chemistry from Hebrew University and a Ph.D. in biochemistry from Israel Institute of Technology.
We
believe that Dr. Mayer’s qualifications to serve on our Board include his experience as an executive in the biotechnology
industry, as well as his experience and relevant education in the fields of chemistry and biochemistry.
Mr.
Kevin Rakin became a director in August 2016 and Chairman of the Board in July 2017. Mr. Rakin is a co-founder
and partner at HighCape Partners, a growth equity life sciences fund where he has served since 2013. From June 2011 to November
2012, Mr. Rakin was the President of Regenerative Medicine at Shire plc, or Shire, a leading specialty biopharmaceutical company.
Prior to joining Shire, Mr. Rakin served as the Chairman and Chief Executive Officer of Advanced BioHealing, Inc. from 2007 until
its acquisition by Shire for $750 million in June 2011. Mr. Rakin currently serves on the boards of Nyxoah SA, HighCape Capital
Acquisition Corp., Aziyo Biologics, Inc. and on the boards of number of private companies. Mr. Rakin holds an MBA from Columbia
University and received his graduate and undergraduate degrees in Commerce from the University of Cape Town, South Africa.
We
believe that Mr. Rakin’s qualifications to serve on our Board include his extensive experience as an executive in the biotechnology
industry, as well as his service in positions in various companies as a chief executive officer, chief financial officer and president
and his involvement in public and private financings and mergers and acquisitions in the biotechnology industry.
Mr.
Leonard Sank became a director in October 2007. Mr. Sank is a South African entrepreneur and businessman,
whose interests lie in entrepreneurial endeavors and initiatives, with over 20 years’ experience of playing significant
leadership roles in developing businesses. For the past nineteen years, Mr. Sank has served on the boards of a few national businesses
and local non-profit charity organizations in Cape Town and South Africa, where he resides.
We
believe that Mr. Sank’s qualifications to serve on our Board include his years of experience in development stage businesses,
as well as his experience serving as a director of many entities.
Mr.
Gao Xiaoming became a director in July 2019. Mr. Gao has more than 25 years’ experience in the bio-pharmaceutical
field. Mr. Gao has experience in the registration, license-in, sales and promotion of pharmaceuticals and was involved in the
introduction of Novo Nordisk (Denmark)’s insulin into China. Mr. Gao is proficient in the insulin industry. From 2005 to
2009, Mr. Gao led a team for the registration of imported Insulin-SciLin in China and obtained an Imported Drug License. Since
2007, Mr. Gao founded Hefei Tianmai Biotechnology Development Co., Ltd. and HTIT, which are committed to the research, development
and commercialization of high-tech bio-pharmaceutical products. Mr. Gao is the Chairman and chief executive officer of HTIT.
We
believe that Mr. Gao’s qualifications to serve on our Board include his years of experience in the bio-pharmaceutical industry
as well as his experience and familiarity with the Eastern market.
35
Board
of Directors
There
are no agreements with respect to the election of directors. Each director is elected for a period of one year at our annual meeting
of stockholders and serves until the next such meeting and until his or her successor is duly elected or until his or her earlier
resignation or removal. The Board may also appoint additional directors. A director so chosen or appointed will hold office until
the next annual meeting of stockholders and until his or her successor is duly elected and qualified or until his or her earlier
resignation or removal. The Board has determined that Aviad Friedman, Arie Mayer, Kevin Rakin, Leonard Sank and Gao Xiaoming are
independent as defined under the rules promulgated by the Nasdaq. Mr. Gao is the chief executive officer of HTIT, a stockholder
holding more than 5% of our common stock and was initially appointed to serve on our Board pursuant to the terms of the securities
purchase agreement with HTIT dated November 30, 2015, but does not otherwise have any relationship with us. The Board considered
this relationship and determined that they would not interfere with Mr. Gao’s exercise of independent judgment in carrying
out the responsibilities of a director.
We
have determined that each of the directors is qualified to serve as a director of the Company based on a review of the experience,
qualifications, attributes and skills of each director. In reaching this determination, we have considered a variety of criteria,
including, among other things: character and integrity; ability to review critically, evaluate, question and discuss information
provided, to exercise effective business judgment and to interact effectively with the other directors; and willingness and ability
to commit the time necessary to perform the duties of a director.
Board
Meeting Attendance
During
fiscal 2020, our Board held 7 meetings and took actions by written consent on 8 occasions. Board members are encouraged to attend
our annual meetings of stockholders.
All
of our directors, except Mr. Gao Xiaoming, attended at least 75% of the aggregate number of meetings of the Board and the committees
that were held during the period such director served on the Board.
Committees
Audit
Committee and Audit Committee Financial Expert
The
members of our Audit Committee are Aviad Friedman, Arie Mayer and Kevin Rakin. Our Board has determined that Aviad Friedman is
an “audit committee financial expert” as set forth in Item 407(d)(5) of Regulation S-K and that all members of the
Audit Committee are “independent” as defined by the rules of the SEC and the Nasdaq rules and regulations. The Audit
Committee operates under a written charter that is posted on the “Investors” section of our website, www.oramed.com.
The primary responsibilities of our Audit Committee include:
● Overseeing
the accounting and financial reporting processes of the Company and the audits of the
financial statements of the Company;
● Appointing,
compensating and retaining our registered independent public accounting firm;
● Overseeing
the work performed by any outside accounting firm;
● Assisting
the Board in fulfilling its responsibilities by reviewing: (i) the financial reports
provided by us to the SEC, our stockholders or to the general public and (ii) our internal
financial and accounting controls; and
● Recommending,
establishing and monitoring procedures designed to improve the quality and reliability
of the disclosure of our financial condition and results of operations.
Compensation
Committee
The
members of our Compensation Committee are Aviad Friedman, Kevin Rakin and Leonard Sank. The Board has determined that all of the
members of the Compensation Committee are “independent” as defined by the rules of the SEC and Nasdaq rules and regulations.
The Compensation Committee operates under a written charter that is posted on the “Investors” section of our website,
www.oramed.com. The primary responsibilities of our Compensation Committee include:
36
● Reviewing,
negotiating and approving, or recommending for approval by our Board the salaries and
incentive compensation of our executive officers;
● Administering
our equity based plans and making recommendations to our Board with respect to our incentive-compensation
plans and equity-based plans; and
● Making
recommendations to our Board with respect to director compensation.
Nominating
Committee
The
members of our Nominating Committee are Aviad Friedman and Leonard Sank. The Board has determined that all of the members of the
Nominating Committee are “independent” as defined by the rules of the SEC and Nasdaq rules and regulations. The Nominating
Committee operates under a written charter that is posted on the “Investors” section of our website, www.oramed.com.
The primary responsibilities of our Nominating Committee include:
● Overseeing
the composition and size of the Board, developing qualification criteria for Board members
and actively seeking, interviewing and screening individuals qualified to become Board
members for recommendation to the Board;
● Recommending
the composition of the Board for each annual meeting of stockholders; and
● Reviewing
periodically with the Chairman of the Board and the Chief Executive Officer the succession
plans relating to positions held by directors, and making recommendations to the Board
with respect to the selection and development of individuals to occupy those positions.
Delinquent
Section 16(a) Reports
Based
solely upon a review of Forms 3, 4 and 5, and amendments thereto, furnished to us during fiscal 2020, we believe that during fiscal
2020, our executive officers, directors and all persons who own more than ten percent of a registered class of our equity securities
complied with all Section 16(a) filing requirements, except: (a) Aviad Friedman, one of our directors, failed to timely file a
Form 4 reporting his January 8, 2020 acquisition of options to purchase 20,000 shares of our common stock. Mr. Friedman filed
a Form 4 reporting this transaction on January 14, 2020, (b) Gao Xiaoming, one of our directors, failed to timely file a Form
4 reporting his January 8, 2020 acquisition of options to purchase 20,000 shares of our common stock. Mr. Gao filed a Form 4 reporting
this transaction on January 14, 2020, (c) Miriam Kidron, our Chief Scientific Officer and one of our directors, failed to timely
file a Form 4 reporting her January 8, 2020 acquisition of options to purchase 100,000 shares of our common stock. Ms. Kidron
filed a Form 4 reporting this transaction on January 14, 2020, (d) Nadav Kidron, our President, Chief Executive Officer and one
of our directors, failed to timely file a Form 4 reporting his January 8, 2020 acquisition of options to purchase 190,000 shares
of our common stock. Mr. Kidron filed a Form 4 reporting this transaction on January 14, 2020, (d) Arie Mayer, one of our directors,
failed to timely file a Form 4 reporting his January 8, 2020 acquisition of options to purchase 20,000 shares of our common stock.
Mr. Mayer filed a Form 4 reporting this transaction on January 14, 2020, (e) Kevin Rakin, one of our directors, failed to timely
file a Form 4 reporting his January 8, 2020 acquisition of options to purchase 20,000 shares of our common stock. Mr. Rakin filed
a Form 4 reporting this transaction on January 14, 2020, and (f) Leonard Sank, one of our directors, failed to timely file a Form
4 reporting his January 8, 2020 acquisition of options to purchase 20,000 shares of our common stock. Mr. Sank filed a Form 4
reporting this transaction on January 14, 2020.
Code
of Ethics
We
have adopted a Code of Ethics and Business Conduct for our senior officers, directors and employees. A copy of the Code of Ethics
and Business Conduct is located at our website at www.oramed.com. We intend to satisfy the disclosure requirement regarding any
amendment to, or a waiver from, a provision of the Code of Ethics that applies to our Chief Executive Officer, or CEO, Chief Financial
Officer or controller, or persons performing similar functions and that relates to the Code of Ethics by posting such information
on our website, www.oramed.com.
37
ITEM
11. EXECUTIVE COMPENSATION.
Compensation
Discussion and Analysis
This
section explains the policies and decisions that shape our executive compensation program, including its specific objectives and
elements, as it relates to our “named executive officers,” or NEOs. Our NEOs for fiscal 2020 are those four individuals
listed in the “Summary Compensation Table” below. The Compensation Committee believes that our executive compensation
is appropriately designed to incentivize our named executive officers to work for our long-term prosperity, is reasonable in comparison
with the levels of compensation provided by comparable companies and reflects a reasonable cost. We believe our named executive
officers are critical to the achievement of our corporate goals, through which we can drive stockholder value.
The
Compensation Committee of our Board is comprised solely of independent directors as defined by Nasdaq and non-employee directors
as defined by Rule 16b-3 under the Exchange Act. The Compensation Committee has the authority and responsibility to review and
approve the compensation of our CEO and other executive officers. Other information concerning the structure, roles and responsibilities
of our Compensation Committee is set forth in “Board Meetings and Committees—Compensation Committee” section.
Our
executive compensation program and our NEOs’ compensation packages are designed around the following objectives:
●
attract, hire, and retain
talented and experienced executives;
●
motivate,
reward and retain executives whose knowledge, skills and performance are critical to our success;
●
ensure fairness among the executive management
team via recognizing the contributions of each executive to our success;
●
focus executive behavior
on achievement of our corporate objectives and strategy; and
●
align the interests of management
and stockholders by providing management with longer-term incentives through equity ownership.
The
Compensation Committee reviews the allocation of compensation components regularly to ensure alignment with strategic and operating
goals, competitive market practices and legislative changes. The Compensation Committee does not apply a specific formula to determine
the allocation between cash and non-cash forms of compensation. Certain compensation components, such as base salaries, benefits
and perquisites, are intended primarily to attract, hire, and retain well-qualified executives. Other compensation elements, such
as long-term incentive opportunities, are designed to motivate and reward performance. Long-term incentives are intended to reward
NEOs for our long-term performance and executing our business strategy, and to strongly align NEOs’ interests with those
of stockholders.
With
respect to equity compensation, the Compensation Committee makes awards to executives under our 2019 Stock Incentive Plan, as
amended and restated, or the 2019 Plan. Executive compensation is paid or granted based on such matters as the Compensation Committee
deems appropriate, including our financial and operating performance and the alignment of the interests of the executive officers
and our stockholders.
38
Elements
of Compensation
Our
executive officer compensation program is comprised of: (i) base salary or monthly compensation; (ii) discretionary bonus; (iii)
long-term equity incentive compensation in the form of stock option grants; and (iv) benefits and perquisites.
In
establishing overall executive compensation levels and making specific compensation decisions for our NEOs in fiscal 2020, the
Compensation Committee considered a number of criteria, including the executive’s position, scope of responsibilities, prior
base salary and annual incentive awards and expected contribution.
Generally,
our Compensation Committee reviews and, as appropriate, approves compensation arrangements for the NEOs from time to time but
not less than once each year. The Compensation Committee also takes into consideration the CEO’s recommendations for executive
compensation of the other NEOs. The CEO generally presents these recommendations at the time of our Compensation Committee’s
review of executive compensation arrangements.
Base
Salary
The
Compensation Committee performs a review of base salaries and monthly compensation for our NEOs from time to time as appropriate.
In determining salaries, the Compensation Committee members also take into consideration the scope of the NEOs’ responsibilities
and independent third-party market data, such as compensation surveys to industry, individual experience and performance and contribution
to our clinical, regulatory, commercial and operational performance. None of the factors above has a dominant weight in determining
the compensation of our named executive officers, and our Compensation Committee considers the factors as a whole when considering
such compensation. In addition, our Compensation Committee uses comparative data regarding compensation paid by peer companies
in order to obtain a general understanding of current trends in compensation practices and ranges of amounts being awarded by
other public companies, and not as part of an analysis or a formula.
We
believe that a competitive base salary and monthly compensation is a necessary element of any compensation program that is designed
to attract and retain talented and experienced executives. We also believe that attractive base salaries can motivate and reward
executives for their overall performance. Base salary and monthly compensation are established in part based on the individual
experience, skills and expected contributions to our performance, as well as such executive’s performance during the prior
year. Generally, we believe that executives’ base salaries should be targeted near the median of the range of salaries for
executives in similar positions with similar responsibilities, experience and performance at comparable companies. Compensation
adjustments are made occasionally based on changes in an executive’s level of responsibility, company progress or on changed
local and specific executive employment market conditions.
In
fiscal 2020, our Compensation Committee increased the base salaries of two of our NEOs by 10% and 15% as it deemed this to be
a reasonable rate based on, among other factors, such NEO’s increased responsibilities and time passed since the last salary
increase.
Performance
Based Bonus
Our
NEOs are eligible to receive discretionary annual bonuses based upon performance. The amount of annual bonus to our NEOs is based
on various factors, including, among others, the achievement of scientific and business goals and our financial and operational
performance. The Compensation Committee takes into account the overall performance of the individuals, as well as the overall
performance of the Company over the period being reviewed and the recommendation of management. For any given year, the compensation
objectives vary, but relate generally to strategic factors such as developments in our clinical path, the execution of a license
agreement for the commercialization of product candidates, the establishment of key strategic collaborations, the build-up of
our pipeline and financial factors such as capital raising. Bonuses are awarded generally based on corporate performance, with
adjustments made within a range for individual performance, at the discretion of the Compensation Committee. The Compensation
Committee determines, on a discretionary basis, the size of the entire bonus pool and the amount of the actual award to each NEO.
The overall payment is also based on historic compensation of the NEOs.
39
We
believe that annual bonuses payable based on the achievement of short-term corporate goals incentivize our NEOs to create stockholder
value and attain short-term performance objectives.
Long-Term
Equity Incentive Compensation
Long-term
incentive compensation allows the NEOs to share in any appreciation in the value of our common stock. The Compensation Committee
believes that stock participation aligns executive officers’ interests with those of our stockholders. Equity incentive
awards are generally made at the commencement of employment and following a significant change in job responsibilities, or to
meet other special retention or performance objectives. The amounts of the awards are designed to reward past performance and
create incentives to meet long-term objectives. Awards are made at a level expected to be competitive within the biotechnology
industry, as well as with Israeli-based companies. Awards are made on a discretionary basis and not pursuant to specific criteria
set out in advance. In determining the amount of each grant, the Compensation Committee also takes into account the number of
shares held by the executive prior to the grant. The vesting schedule for NEOs generally provides for annual installments for
new grants, though the Compensation Committee also utilizes quarterly vesting from time to time, as well as performance-based
vesting. The Compensation Committee believes that time-based vesting encourages recipients to build stockholder value over a long
period of time and that performance-based vesting encourages recipients to achieve goals that benefit the Company.
Benefits
and Perquisites
Generally,
benefits available to NEOs are available to all employees on similar terms and include welfare benefits, paid time-off, life and
disability insurance and other customary or mandatory social benefits in Israel. We provide our NEOs with a phone and a company
car, which are customary benefits in Israel to managers and officers.
We
do not believe that the benefits and perquisites described above deviate materially from the customary practice for compensation
of executive officers by other companies similar in size and stage of development in Israel. These benefits represent a relatively
small portion of the executive officers’ total compensation.
The Company pays for
certain direct costs, related taxes and expenses incurred in connection with the relocation of our CEO to United States. During
fiscal 2020, such relocation expenses totaled approximately $515,693, and included mainly payments intended to reflect the difference
in the cost of living between Israel and the United States, relocation expenses, accommodation allowances, education allowances,
health insurance and related taxes.
Say-on-Pay
Vote
Our
stockholders approved, on an advisory basis, our executive compensation program at our annual meeting of stockholders held on
August 3, 2020. We did not seek or receive any specific feedback from our stockholders concerning our executive compensation program
during the past fiscal year. The Compensation Committee did not specifically rely on the results of the prior vote in making any
compensation-related decisions during fiscal 2020.
REPORT
OF THE COMPENSATION COMMITTEE
The
Compensation Committee has reviewed and discussed the foregoing Compensation Discussion and Analysis required by Item 402(b) of
Regulation S-K with our management and, based on such review and discussions, the Compensation Committee recommended to our Board
that the Compensation Discussion and Analysis be included in this Annual Report on Form 10-K and in our proxy statement relating
to our next annual meeting of stockholders.
Compensation
Committee Members:
Aviad
Friedman
Kevin
Rakin
Leonard
Sank
40
SUMMARY
COMPENSATION TABLE
The
following table sets forth the compensation earned by our NEOs for fiscals 2020, 2019 and 2018.
Name and Principal Position
Year
(1)
Salary
($)
(2)
Bonus
($)
(2)(3)
Option
Awards
($)
(4)(5)
All Other
Compensation
($)
(2)(6)
Total
($)
Nadav Kidron
2020
439,076
220,582
569,062
539,131
1,767,851
President and CEO and director (7)
2019
419,460
224,975
398,910
507,750
1,551,095
2018
436,310
148,795
522,569
442,326
1,550,000
Miriam Kidron
2020
305,840
70,000
299,506
13,354
688,700
Chief Scientific Officer and director (8)
2019
267,386
123,149
211,128
14,503
616,166
2018
273,595
46,614
253,204
13,643
587,056
Avraham Gabay
2020
130,554
15,591
-
44,912
191,418
Chief Financial Officer (9)
2019
32,122
-
73,928
9,441
115,491
Joshua Hexter
2020
190,801
12,169
351,128
54,735
608,833
Chief Operating & Business Officer(10)
2019
52,848
-
-
9,022
61,870
2018
161,002
26,895
269,196
50,505
507,598
(1) The
information is provided for each fiscal year, which begins on September 1 and ends on
August 31.
(2) Amounts
paid for Salary, Bonus and All Other Compensation were originally denominated in NIS
and were translated into U.S. Dollars at the then current exchange rate for each payment.
(3) Bonuses
were granted at the discretion of the Compensation Committee.
(4) The
amounts reflect the grant date fair value, as calculated pursuant to FASB ASC Topic 718,
of these option awards. The assumptions used to determine the fair value of the option
awards are set forth in Note 8 to our audited consolidated financial statements included
in this Annual Report on Form 10-K. Our NEOs will not realize the value of these awards
in cash unless and until these awards are exercised and the underlying shares subsequently
sold.
(5) Amounts
exclude the fair market value of the options that were re-granted on September 11, 2020,
as it was offset by the negative amount created by the cancelled options (that is, it
was accounted for as a modification under FASB ASC Topic 718, and no incremental compensation
expense was recorded). For more information about the regrant see Note 7(a) to our audited
consolidated financial statements included in this Annual Report on Form 10-K. For more
information about the regrant fair market value see “Grants of Plan-Based Awards”
below.
(6) See
“All Other Compensation Table” below.
(7) Mr.
Kidron receives certain compensation from Oramed Ltd. through KNRY, Ltd., an Israeli
entity owned by Dr. Miriam Kidron, or KNRY. See “—Employment and Consulting
Agreements” below.
(8) Dr.
Kidron receives compensation from Oramed Ltd. through KNRY. See “—Employment
and Consulting Agreements” below.
(9) Mr.
Gabay was appointed as Chief Financial Officer, effective June 1, 2019.
(10) Mr.
Hexter was appointed Chief Operating & Business Officer, effective September 19,
2019. From 2013 to 2018, Mr. Hexter served as Chief Operating Officer and VP Business
Development of the Company.
41
All
Other Compensation Table
The
“All Other Compensation” amounts set forth in the Summary Compensation Table above consist of the following:
Name
Year
Automobile-
Related Expenses
($)
Manager’s
Insurance*
($)
Education
Fund*
($)
Relocation Expenses**
($)
Total
($)
Nadav Kidron
2020
23,438
--
--
515,693
539,131
2019
21,090
--
--
486,660
507,750
2018
12,596
--
--
429,730
442,326
Miriam Kidron
2020
13,354
--
--
--
13,354
2019
14,503
--
--
--
14,503
2018
13,643
--
--
--
13,643
Avraham Gabay
2020
16,625
18,606
9,681
--
44,912
2019
2,808
4,405
2,228
--
9,441
Joshua Hexter
2020
13,685
26,820
14,230
--
54,735
2019
4,409
1,985
2,628
--
9,022
2018
13,909
24,623
11,973
--
50,505
* Manager’s
insurance and education funds are customary benefits provided to employees based in Israel.
Manager’s insurance is a combination of severance savings (in accordance with Israeli
law), defined contribution tax-qualified pension savings and disability insurance premiums.
An education fund is a savings fund of pre-tax contributions to be used after a specified
period of time for educational or other permitted purposes.
** Relocation
expenses represents additional compensation for the period during which Mr. Kidron was
in the United States. These expenses mainly include relocation expenses, supplemental
living expenses, accommodation allowances, education allowances, health insurance and
related costs.
Employment
and Consulting Agreements
On
July 1, 2008, Oramed Ltd. entered into a consulting agreement with KNRY, whereby Mr. Nadav Kidron, through KNRY, provides services
as President and Chief Executive Officer of both the Company and Oramed Ltd., or the Nadav Kidron Consulting Agreement. Additionally,
on July 1, 2008, Oramed Ltd. entered into a consulting agreement with KNRY whereby Dr. Miriam Kidron, through KNRY, provides services
as Chief Scientific Officer of both the Company and Oramed Ltd., or the Miriam Kidron Consulting Agreement. We refer to the Miriam
Kidron Consulting Agreement and Nadav Kidron Consulting Agreement collectively as the Consulting Agreements.
The
Consulting Agreements are both terminable by either party upon 140 days prior written notice. The Consulting Agreements, as amended,
provide that KNRY will be reimbursed for reasonable expenses incurred in connection with performance of the Consulting Agreements
and that Nadav Kidron receives a monthly consulting fee of NIS 127,570 and Miriam Kidron receives a monthly consulting fee of
NIS 92,522. Pursuant to the Consulting Agreements, KNRY, Nadav Kidron and Miriam Kidron each agree that during the term of the
Consulting Agreements and for a 12-month period thereafter, none of them will compete with Oramed Ltd. nor solicit employees of
Oramed Ltd.
42
We,
through Oramed Ltd., have entered into an employment agreement with Avraham Gabay as of May 16, 2019, pursuant to which Mr. Gabay
was appointed as Chief Financial Officer, Treasurer and Secretary of the Company and Oramed Ltd., effective June 1, 2019. In accordance
with the employment agreement, as amended, Mr. Gabay’s current gross monthly salary is NIS 38,500. In addition, Mr. Gabay
is provided with a cellular phone and a company car pursuant to the terms of his agreement.
We,
through Oramed Ltd., have entered into an employment agreement with Joshua Hexter as of August 5, 2019, pursuant to which Mr.
Hexter was appointed as Chief Operating & Business Officer of the Company and Oramed Ltd., effective September 19, 2019. In
accordance with the employment agreement, as amended, Mr. Hexter’s current gross monthly salary is NIS 56,000. In addition,
Mr. Hexter is provided with a cellular phone and a company car pursuant to the terms of his agreement.
We
have entered into indemnification agreements with our directors and officers pursuant to which we agreed to indemnify each director
and officer for any liability he or she may incur by reason of the fact that he or she serves as our director or officer, to the
maximum extent permitted by law.
Potential
Payments upon Termination or Change-in-Control
We
have no plans or arrangements in respect of remuneration received or that may be received by our named executive officers to compensate
such officers in the event of termination of employment (as a result of resignation, retirement, change-in- control) or a change
of responsibilities following a change-in-control.
Pension,
Retirement or Similar Benefit Plans
We
have no arrangements or plans under which we provide pension, retirement or similar benefits for directors or executive officers.
Our directors and executive officers may receive stock options, RSUs or restricted shares at the discretion of our Compensation
Committee in the future.
43
GRANTS
OF PLAN-BASED AWARDS
The
following table shows grants of plan-based equity awards made to our NEOs during fiscal 2020:
Name
Grant Date
Options Awards:
Number of
Securities
Underlying
Options
(#)
Grant Date
Fair Value of
Stock Awards
($)
Avraham
Gabay (1)
9/11/2019
33,146
61,893
Joshua
Hexter (2)
9/11/2019
100,000
224,123
Joshua
Hexter (3)
9/11/2019
100,000
127,005
Miriam
Kidron (4)
9/11/2019
104,000
211,128
Nadav
Kidron (5)
9/11/2019
196,500
398,910
Miriam
Kidron (6)
1/8/2020
100,000
299,506
Nadav
Kidron (7)
1/8/2020
190,000
569,062
(1)
These options were canceled
and re-granted under our 2019 Plan, in the same amounts and under the same terms as the original grants. These options were
originally granted on June 17, 2019. 5,396 vested on December 31, 2019, and the balance vests in 3 equal installments of 9,250
on each of December 31, 2020, December 31, 2021 and December 31, 2022.
(2)
These options were granted under our 2019 Plan
and vest in 16 equal installments of 6,250 on the first day of each three months period beginning November 1, 2019. 25,000
of the options vested as of August 31, 2020.
(3)
These options were granted under the 2019 Plan
and vest upon achievement of certain performance conditions, such as consummating licensing agreements and entering into R&D
collaboration agreements.
(4)
These options were canceled and re-granted under
the 2019 Plan in the same amounts and under the same terms as the original grants. These options were originally granted on
February 26, 2019. 26,000 vested on December 31, 2019, and the balance vests in 3 equal installments of 26,000 on each of
December 31, 2020, December 31, 2021 and December 31, 2022.
(5)
These options were canceled and re-granted under
the 2019 Plan in the same amounts and under the same terms as the original grants. These options were originally granted on
February 26, 2019. 49,125 vested on December 31, 2019, and the balance vests in 3 equal installments of 49,125 on each of
December 31, 2020, December 31, 2021 and December 31, 2022.
(6)
These options were granted under our 2019 Plan
and vest in 4 equal installments of 25,000 on each of December 31, 2020, December 31, 2021, December 31, 2022 and December
31, 2023.
(7)
These options were granted under our 2019 Plan
and vest in 4 equal installments of 47,500 on each of December 31, 2020, December 31, 2021, December 31, 2022 and December
31, 2023.
44
OUTSTANDING
EQUITY AWARDS AT FISCAL YEAR-END
The
following table sets forth information concerning stock options and stock awards held by the NEOs as of August 31, 2020.
Option
Awards
Stock
Awards
Name
Number
of
Securities
Underlying
Unexercised
Options (#)
Exercisable
Number
of
Securities
Underlying
Unexercised
Options (#)
Unexercisable
Option
Exercise
Price
($)
Option
Expiration
Date
Number
of
shares that
have not
vested
(#)
Market
value of
shares that
have not
vested
($)
Nadav
Kidron
72,000
(1)
-
4.08
8/8/22
47,134
(2)
-
12.45
4/9/24
49,000
(3)
-
7.77
6/30/27
48,500
(4)
48,500
(4)
8.14
1/31/28
0
(7)(8)
0
49,125
(10)
147,375
(10)(13)
3.16
2/26/29
190,000
(15)
4.80
1/8/30
Miriam Kidron
72,000
(1)
-
4.08
8/8/22
47,134
(2)
-
12.45
4/9/24
69,999
(5)
-
7.77
6/30/27
23,500
(6)
23,500
(6)
8.14
1/31/28
0
(9)
0
26,000
(11)
78,000
(11)(13)
3.16
2/26/29
100,000
(16)
4.80
1/8/30
Avraham Gabay
5,396
(12)
27,750
(12)(13)
3.55
6/17/29
Joshua Hexter
25,000
(14)
175,000
(14)
3.69
9/11/29
(1) On
August 8, 2012, 72,000 options were granted to each of Nadav Kidron and Miriam Kidron
under the Second Amended and Restated 2008 Stock Incentive Plan, or the 2008 Plan, at
an exercise price of $4.08 per share; 21,000 of such options vested immediately on the
date of grant and the remainder vested in seventeen equal monthly installments, commencing
on August 31, 2012. The options have an expiration date of August 8, 2022.
(2) On
April 9, 2014, 47,134 options were granted to each of Nadav Kidron and Miriam Kidron
under the 2008 Plan at an exercise price of $12.45 per share; 15,710 of such options
vested on April 30, 2014 and the remainder vested in eight equal monthly installments,
commencing on May 31, 2014. The options have an expiration date of April 9, 2024.
(3) On
June 30, 2017, 147,000 options were granted to Nadav Kidron under the 2008 Plan at an
exercise price of $7.77 per share; 49,000 of such options vested on December 31, 2017
and the remainder vest in two equal installments of 49,000 on each of December 31, 2018
and December 31, 2019, subject to the Company share price reaching the target of $9.50
and $12.50 per share, respectively. The options expire on June 30, 2027. As of August
31, 2020, 98,000 options were forfeited.
45
(4) On
January 31, 2018, 97,000 options were granted to Nadav Kidron under the 2008 Plan at
an exercise price of $8.14 per share; 48,500 of such options vested on each of January
1, 2019 and January 1, 2020 and the reminder vest in two equal installments of 24,250
on each of January 1, 2021 and January 1, 2022. The options expire on January 31, 2028.
(5) On
June 30, 2017, 69,999 options were granted to Miriam Kidron under the 2008 Plan at an
exercise price of $7.77 per share; Such options vested in 3 equal installments of 23,333
on each of December 31, 2017, December 31, 2018 and December 31, 2019. The options have
an expiration date of June 30, 2027.
(6) On
January 31, 2018, 47,000 options were granted to Miriam Kidron under the 2008 Plan at
an exercise price of $8.14 per share; 23,500 of such options vested in 2 equal installments
of 11,750 on each of January 1, 2019 and January 1, 2020 and the reminder shall vest
in 2 equal installments of 11,750 on each of January 1, 2021 and January 1, 2022. The
options expire on January 31, 2028.
(7) On
November 13, 2014, 9,788 RSUs, representing a right to receive shares of the Company’s
common stock, were granted to Nadav Kidron. The RSUs vested in two equal installments,
each of 4,894 shares, on November 30 and December 31, 2014. The shares of common stock
underlying the RSUs will be issued upon request of the grantee.
(8) On
February 23, 2015, 79,848 RSUs, representing a right to receive shares of the Company’s
common stock, were granted to Nadav Kidron. The RSUs vested in 23 installments consisting
of one installment of 6,654 shares on February 28, 2015 and 22 equal monthly installments
of 3,327 shares each, commencing March 31, 2015. The shares of common stock underlying
the RSUs will be issued upon request of the grantee.
(9) On
June 30, 2017, 75,000 RSUs, representing a right to receive shares of the Company’s
common stock, were granted to Miriam Kidron. The RSUs vested immediately, have an exercise
price of $0.012 per share of common stock and expire on June 30, 2027.
(10) On
February 26, 2019, 196,500 options were granted to Nadav Kidron under the 2008 Plan at
an exercise price of $3.16 per share; 49,125 of such option vested on December 31, 2019
and the reminder shall vest in three equal installments of 49,125 on each of December
31, 2020, December 31, 2021 and December 31, 2022. The options expire on February 26,
2029. For additional information please see note 13 below.
(11) On
February 26, 2019, 104,000 options were granted to Miriam Kidron under the 2008 Plan
at an exercise price of $3.16 per share; 26,000 of such option vested on December 31,
2019 and the reminder shall vest in three equal installments of 26,000 on each of December
31, 2020, December 31, 2021 and December 31, 2022. The options expire on February 26,
2029. For additional information please see note 13 below.
(12) On
June 17, 2019, 33,146 options were granted to Avraham Gabay under the 2008 Plan at an
exercise price of $3.55 per share; 5,396 of the options vested on December 31, 2019 and
the remining options shall vest in 3 equal installments of 9,250 on each of December
31, 2020, December 31, 2021 and December 31, 2022. The options expire on June 17, 2029.
For additional information please see note 13 below.
(13) On
September 11, 2019, the options in this table were canceled and re-granted under the
2019 Plan in the same amounts and under the same terms as the original grants.
(14) On
September 11, 2019, 200,000 options were granted to Joshua Hexter under the 2019 Plan
at an exercise price of $3.69 per share; 100,000 of such options shall vest in 16 equal
installments of 6,250 on the first day of every three month period beginning November
1, 2019 and the remaining 100,000 shall vest upon achievement of certain performance
conditions, such as consummating licensing agreements and entering into R&D collaboration
agreements. The options expire on November 9, 2029.
(15) On
January 8, 2020, 190,000 options were granted to Nadav Kidron under the 2019 Plan at
an exercise price of $4.80 per share. Such options will vest in 4 equal installments
of 47,500 on each of December 31, 2020, December 31, 2021, December 31, 2022 and December
31, 2023. The options expire on January 8, 2030.
(16) On
January 8, 2020, 100,000 options were granted to Miriam Kidron under the 2019 Plan at
an exercise price of $4.80 per share. Such options will vest in 4 equal installments
of 25,000 on each of December 31, 2020, December 31, 2021, December 31, 2022 and December
31, 2023. The options expire on January 8, 2030.
Compensation
Committee Interlocks and Insider Participation
During
fiscal 2020, Mr. Aviad Friedman, Mr. Kevin Rakin and Mr. Leonard Sank served as the members of our Compensation Committee. None
of the members of our Compensation Committee is, or has been, an officer or employee of ours.
During
the last year, none of our NEOs served as: (1) a member of the compensation committee (or other committee of the Board performing
equivalent functions or, in the absence of any such committee, the entire board of directors) of another entity, one of whose
executive officers served on the compensation committee; (2) a director of another entity, one of whose executive officers served
on the compensation committee; or (3) a member of the compensation committee (or other committee of the board of directors performing
equivalent functions or, in the absence of any such committee, the entire board of directors) of another entity, one of whose
executive officers served as a director on our Board.
46
DIRECTOR
COMPENSATION
The
following table provides information regarding compensation earned by, awarded or paid to each person for serving as a director
who is not an executive officer during fiscal 2020:
Name of Director
Fees
Earned or
Paid in
Cash
($)
Stock
Awards
(2)
($)
Option
Awards
(3) ($)
All Other
Compensation
($)
Total
($)
Nadav Kidron (1)
-
-
-
-
-
Miriam Kidron (1)
-
-
-
-
-
Aviad Friedman
20,000
-
55,505
-
75,505
Arie
Mayer (4)
15,000
-
55,505
-
70,505
Kevin Rakin
20,000
-
55,505
-
75,505
Leonard Sank
20,000
-
55,505
-
75,505
Gao Xiaoming
20,000
-
55,505
-
75,505
(1) Please
refer to the Summary Compensation Table for executive compensation with respect to the named individual.
(2) As
of August 31, 2020, our non-employee directors then in office held options to purchase shares of our common stock as follows:
Name of Director
Aggregate Number
of Shares
Underlying
Stock
Awards
Aviad Friedman
40,857
Arie Mayer
20,000
Kevin Rakin
92,470
Leonard Sank
69,867
Gao Xiaoming
20,000
(3) The
amounts reflect the grant date fair value, as calculated pursuant to FASB ASC Topic 718, of these option awards. The assumptions
used to determine the fair value of the option awards are set forth in Note 8 to our audited consolidated financial statements
included in this Annual Report on Form 10-K. Our directors will not realize the value of these awards in cash unless and until
these awards are exercised and the underlying shares subsequently sold.
(4) Mr.
Mayer joined the Board as of December 5, 2019.
Our
directors are entitled to reimbursement for reasonable travel and other out-of-pocket expenses incurred in connection with attendance
at meetings of our Board. Each independent director is entitled to receive as remuneration for his or her service as a member
of the Board a sum equal to $20,000 per annum, to be paid quarterly after the close of each quarter. Our executive officers did
not receive additional compensation for service as directors. The Board may award special remuneration to any director undertaking
any special services on behalf of us other than services ordinarily required of a director.
Other
than as described above, we have no present formal plan for compensating our directors for their service in their capacity as
directors. Other than indicated above, no director received and/or accrued any compensation for his services as a director, including
committee participation and/or special assignments during fiscal 2020.
47
ITEM
12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS.
Stock
Option Plans
Our
Board adopted the 2008 Plan and the 2019 Plan in order to attract and retain quality personnel.
The
2008 Plan, which is no longer utilized for new grants, provided for the grant of stock options, restricted stock, RSUs, and stock
appreciation rights, collectively referred to as “awards.” Under the 2008 Plan, as amended, 2,400,000 shares were
reserved for the grant of awards. As of August 31, 2020, options with respect to 2,287,989 shares had been granted, of which 563,804
had been forfeited, 182,227 had been exercised and 841,303 have expired. As of August 31, 2020, 525,824 RSUs had been granted,
of which 164,636 have vested and the shares of common stock underlying those RSUs have been issued and 33,248 have been forfeited.
In
August 2019, the Company became aware of a shareholder derivative claim and putative class action alleging, among other things,
that the 2008 Plan may have terminated in 2018. However, the Company disputes these claims and believes that the 2008 Plan does
not terminate until 2026, and any suggestion to the contrary is not well-founded. For the sake of clarity and out of an abundance
of caution, the Company adopted the 2019 Plan, which was approved on August 29, 2019, at the Company’s 2019 shareholders
meeting.
The
2019 Plan provides for the grant of stock options, restricted stock, RSUs, and stock appreciation rights, collectively referred
to as “awards.” Under the 2019 Plan, 1,000,000 shares were initially reserved for the grant of awards. On June 29,
2020, and August 3, 2020, respectively, our Board and stockholders approved to amend and restate the 2019 Plan, the principal
change being an increase in the number of shares of common stock available under the 2019 Plan from 1,000,000 shares to 3,000,000
shares. Stock options granted under the 2019 Plan may be either incentive stock options under the provisions of Section 422 of
the Code, or non-qualified stock options. Under the 2019 Plan, as amended, 3,000,000 shares are reserved for the grant of awards,
which may be issued at the discretion of our Board from time to time. As of August 31, 2020, options with respect to 999,646 shares
have been granted, of which 20,000 have expired and none of them were exercised or forfeited. No RSUs have been granted under
the 2019 Plan. Since the Company had granted options during the time after the 2008 Plan allegedly terminated, and out of an abundance
of caution, the Company canceled these grants and re-granted certain of the options under 2019 Plan in the same amounts and under
the same terms as the original grants.
The
following table sets forth additional information with respect to our equity compensation plans as of August 31, 2020:
Plan category
Number of
securities to
be issued
upon
exercise of
outstanding
options, RSUs
and rights
(a)
Weight-
average
exercise
price of
outstanding
options, RSUs
and rights
(b)
Number of
securities
remaining
available for
future
issuance
under equity
compensation
plans
(excluding
securities
reflected in
column (a))
(c)
Equity compensation plans approved by security holders
1,864,664
$ 4.97
2,000,354
Equity compensation plans not approved by security holders
--
--
--
Total
1,864,664
$ 4.97
2,000,354
48
Security
Ownership of Certain Beneficial Owners and Management
The
following table sets forth certain information regarding the beneficial ownership of our common stock as of November 24, 2020
by: (1) each person who is known by us to own beneficially more than 5% of our common stock; (2) each director; (3) each of our
NEOs listed above under “Summary Compensation Table”; and (4) all of our directors and current executive officers
as a group. On such date, we had 23,675,530 shares of common stock outstanding.
As
used in the table below and elsewhere in this form, the term “beneficial ownership” with respect to a security consists
of sole or shared voting power, including the power to vote or direct the vote, and/or sole or shared investment power, including
the power to dispose or direct the disposition, with respect to the security through any contract, arrangement, understanding,
relationship, or otherwise, including a right to acquire such power(s) during the next 60 days following November 24, 2020. Inclusion
of shares in the table does not, however, constitute an admission that the named stockholder is a direct or indirect beneficial
owner of those shares. Unless otherwise indicated, (1) each person or entity named in the table has sole voting power and investment
power (or shares that power with that person’s spouse) with respect to all shares of common stock listed as owned by that
person or entity and (2) the address of each of the individuals named below is: c/o Oramed Pharmaceuticals Inc., 1185 Avenue of
the Americas, Third Floor, New York, NY 10036.
Name and Address of Beneficial Owner
Number of
Shares
Percentage
of Shares
Beneficially
Owned
Regals Fund LP
152 West 57th Street, 9th Floor
New York, NY 10019
1,317,123 (1)
5.6 %
Nadav Kidron #+
2,718,813 (2)
11.4 %
Miriam Kidron #+
376,383 (3)
1.6 %
Aviad Friedman #
49,714 (4)
*
Avraham Gabay+
14,646 (5)
*
Joshua Hexter+
101,250 (6)
*
Arie Mayer #
9,666 (7)
*
Kevin Rakin #
79,136 (8)
*
Leonard Sank #
628,546 (9)
2.7 %
Gao Xiaoming #
1,162,033 (10)
4.9 %
All current executive officers and directors, as a group (nine persons)
3,999,881 (11)
16.7 %
* Less
than 1%
# Director
+ NEO
(1) Regals
Management is the investment manager of Regals Fund LP, the owner of record of these
shares of common stock. David Slager is the managing member of the general partner of
Regals Management. All investment decisions are made by Mr. Slager, and thus the power
to vote or direct the votes of these shares of common stock, as well as the power to
dispose or direct the disposition of such shares of common stock is held by Mr. Slager
through Regals Management.
(2) Includes
386,634 shares of common stock issuable upon the exercise of outstanding stock options
and 89,636 shares of Common Stock underlying vested RSUs that are issuable upon request.
On November 30, 2015, we entered into a securities purchase agreement with HTIT pursuant
to which, among other things, Nadav Kidron will serve as proxy and attorney in fact of
HTIT, with full power of substitution, to cast on behalf of HTIT all votes that HTIT
is entitled to cast with respect to 1,155,367 shares of common stock, or the Purchased
Shares, at any and all meetings of our stockholders, to consent or dissent to any action
taken without a meeting and to vote all the Purchased Shares held by HTIT in any manner
Mr. Kidron deems appropriate except for matters related to our activities in the People’s
Republic of China, on which Mr. Kidron will consult with HTIT before taking any action
as proxy. Mr. Nadav’s beneficial ownership includes the 1,155,367 shares of common
stock held by HTIT, as well as 218,603 shares of common stock held by Xiaopeng Li, a
former director of the Company, over which he holds a similar proxy.
49
(3) Includes
301,383 shares of common stock issuable upon the exercise of outstanding stock options
and 75,000 shares of Common Stock underlying vested RSUs that are issuable upon request.
(4) Includes
27,523 shares of common stock issuable upon the exercise of outstanding stock options
and 12,191 shares of common stock owned by Shikma, of which Mr. Friedman is the sole
owner and chief executive officer. All investment decisions are made by Mr. Friedman,
and thus the power to vote or direct the votes of these shares of common stock, as well
as the power to dispose or direct the disposition of such shares of common stock is held
by Mr. Friedman through Shikma.
(5) Includes
14,646 shares of common stock issuable upon the exercise of outstanding stock options.
(6) Includes
31,250 shares of common stock issuable upon the exercise of outstanding stock options.
(7) Includes
6,666 shares of common stock issuable upon the exercise of outstanding stock options.
(8) Includes
79,136 shares of common stock issuable upon the exercise of outstanding stock options
(9) Includes:
(a) 374,999 shares of common stock held by Mr. Sank; (b) 78,125 shares of common stock
held by Mr. Sank’s wife; (c) 36,533 shares of common stock issuable to Mr. Sank
upon the exercise of outstanding stock options; and (d) 138,889 shares of common stock
owned by a company wholly owned by a trust of which Mr. Sank is a trustee. Mr. Sank disclaims
beneficial ownership of the securities referenced in (b) and (d) above.
(10) Includes
6,666 shares of common stock issuable upon the exercise of outstanding stock options
and 1,155,367 shares of Common Stock held by HTIT. Mr. Gao is the chairman of HTIT.
(11) Includes
890,467 shares of Common Stock issuable upon the exercise of options beneficially owned
by the referenced persons and 164,636 shares of Common Stock underlying vested RSUs that
are issuable upon request.
ITEM
13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE.
During
fiscals 2020 and 2019, except for compensation arrangements described elsewhere herein, we did not participate in any transaction,
and we are not currently participating in any proposed transaction, or series of transactions, in which the amount involved exceeded
the lesser of $120,000 or one percent of the average of our total assets at year end for the last two completed fiscal years,
and in which, to our knowledge, any of our directors, officers, five percent beneficial security holders, or any member of the
immediate family of the foregoing persons had, or will have, a direct or indirect material interest.
Our
policy is to enter into transactions with related persons on terms that, on the whole, are no less favorable than those available
from unaffiliated third parties. Based on our experience in the business sectors in which we operate and the terms of our transactions
with unaffiliated third parties, we believe that all of the transactions described below met this policy standard at the time
they occurred. All related person transactions are approved by our Board.
On
November 30, 2015, we, our Israeli subsidiary and HTIT entered into a Technology License Agreement, which was further amended,
according to which we granted HTIT an exclusive commercialization license in the Territory related to our oral insulin capsule,
ORMD-0801. Pursuant to this license agreement, HTIT will conduct certain pre-commercialization and regulatory activities with
respect to our subsidiary’s technology related to the ORMD-0801 capsule, and will pay certain royalties and an aggregate
of approximately $37.5 million. On November 30, 2015, we also entered into a securities purchase agreement with HTIT, pursuant
to which, among other things, Mr. Kidron will serve as proxy and attorney in fact of HTIT, with full power of substitution, to
cast on behalf of HTIT all votes that HTIT is entitled to cast with respect to the Purchased Shares at any and all meetings of
our stockholders to consent or dissent to any action taken without a meeting and to vote all the Purchased Shares held by HTIT
in any manner Mr. Kidron deems appropriate except for matters related to our activities in the People’s Republic of China,
on which Mr. Kidron will consult with HTIT before taking any action as proxy.
The
Board has determined that Aviad Friedman, Arie Mayer, Kevin Rakin, Leonard Sank and Gao Xiaoming are independent as defined under
the rules promulgated by Nasdaq.
50
ITEM
14. PRINCIPAL ACCOUNTANT FEES AND SERVICES.
The
aggregate fees billed by Kesselman & Kesselman, independent registered public accounting firm, and member firm of PricewaterhouseCoopers
International Limited, for services rendered to us during fiscals 2020 and 2019:
2020
2019
Audit
Fees (1)
$ 95,000
$ 96,000
Audit-Related
Fees (2)
101,000
-
Tax
Fees (3)
2,000
1,000
All Other Fees
-
-
Total Fees
$ 198,000
$ 97,000
(1) Amount
represents fees paid for professional services for the audit of our consolidated annual
financial statements, review of our interim condensed consolidated financial statements
included in quarterly reports and services that are normally provided by our independent
registered public accounting firm in connection with statutory and regulatory filings
or engagements.
(2) Represents
fees paid for services rendered in connection with our Offering.
(3) Represents
fees paid for tax consulting services.
SEC
rules require that before the independent registered public accounting firm are engaged by us to render any auditing or permitted
non-audit related service, the engagement be: (1) pre-approved by our Audit Committee; or (2) entered into pursuant to pre-approval
policies and procedures established by the Audit Committee, provided the policies and procedures are detailed as to the particular
service, the Audit Committee is informed of each service, and such policies and procedures do not include delegation of the Audit
Committee’s responsibilities to management.
The
Audit Committee pre-approves all services provided by our independent registered public accounting firm. All of the above services
and fees were reviewed and approved by the Audit Committee before the services were rendered.
51
PART
IV
ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES.
(a) Index
to Financial Statements
The
following consolidated financial statements are filed as part of this Annual Report on Form 10-K:
Page
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
F-1
CONSOLIDATED
FINANCIAL STATEMENTS:
Balance sheets
F-2
Statements of comprehensive loss
F-3
Statements of changes in stockholders’ equity
F-4
Statements of cash flows
F-5
Notes to financial statements
F-6 - F-28
________________
_____________________________
________________
52
Report
of Independent Registered Public Accounting Firm
To
the Board of Directors and Stockholders of Oramed Pharmaceuticals Inc.
Opinion
on the Financial Statements
We
have audited the accompanying consolidated balance sheets of Oramed Pharmaceuticals Inc. and its subsidiaries (the “Company”)
as of August 31, 2020 and 2019, and the related consolidated statements of comprehensive loss, changes in stockholders’
equity and cash flows for the years then ended, including the related notes (collectively referred to as the “consolidated
financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects,
the financial position of the Company as of August 31, 2020 and 2019, and the results of their operations and its cash flows for
the years then ended in conformity with accounting principles generally accepted in the United States of America.
Change
in Accounting Principle
As
discussed in Note 1(k) to the audited consolidated financial statements, the Company changed the manner in which it accounts for
revenues from contracts with customers during the year ended August 31, 2019.
Basis
for Opinion
These
consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an
opinion on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered
with the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with
respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities
and Exchange Commission and the PCAOB.
We
conducted our audits of these consolidated financial statements in accordance with the standards of the PCAOB. Those standards
require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements
are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to
perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding
of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s
internal control over financial reporting. Accordingly, we express no such opinion.
Our
audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether
due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis,
evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the
accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the
consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.
/s/ Kesselman & Kesselman
Kesselman & Kesselman
Certified Public Accountants (Isr.)
A member firm of PricewaterhouseCoopers International Limited
Tel Aviv, Israel
November 24, 2020
We have served as the Company’s auditor since 2008.
Kesselman &
Kesselman, Trade Tower, 25 Hamered Street, Tel-Aviv 6812508, Israel,
P.O Box 50005 Tel-Aviv 6150001 Telephone: +972 -3- 7954555,
Fax:+972 -3- 7954556, www.pwc.com/il
F- 1
ORAMED
PHARMACEUTICALS INC.
CONSOLIDATED BALANCE SHEETS
In thousands (except share and per share
data)
August 31,
2020
2019
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$ 19,296
$ 3,329
Short-term deposits (note 2)
11,060
25,252
Marketable securities (note 3)
9,544
3,701
Prepaid expenses and other current assets
611
1,042
Total current assets
40,511
33,324
LONG-TERM ASSETS:
Long-term deposits and investment (note 4)
2
1
Marketable securities (note 3)
3,928
1,295
Amounts funded in respect of employee rights upon retirement
18
19
Property and equipment, net
99
24
Operating lease right of use assets
75
-
Total long-term assets
4,122
1,339
Total assets
$ 44,633
$ 34,663
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES:
Accounts payable and accrued expenses (note 5)
$ 1,699
$ 2,541
Deferred revenues
2,703
2,703
Payable to related parties (note 11c)
90
64
Operating lease liabilities
44
-
Total current liabilities
4,536
5,308
LONG-TERM LIABILITIES:
Deferred revenues
6,947
9,658
Employee rights upon retirement
18
22
Provision for uncertain tax position (note 10f)
11
11
Operating lease liabilities
31
-
Other liabilities
211
271
Total long-term liabilities
7,218
9,962
COMMITMENTS (note 6)
STOCKHOLDERS’ EQUITY:
Common stock, $ 0.012 par value (60,000,000 authorized shares as of August 31, 2020 and 30,000,000 authorized shares as of August 31, 2019; 23,675,530 and 17,383,359 shares issued and outstanding as of August 31, 2020 and 2019, respectively)
284
208
Additional paid-in capital
125,209
100,288
Accumulated deficit
(92,614 )
(81,103 )
Total stockholders’ equity
32,879
19,393
Total liabilities and stockholders’ equity
$ 44,633
$ 34,663
The
accompanying notes are an integral part of the financial statements.
F- 2
ORAMED
PHARMACEUTICALS INC.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
In
thousands (except share and per share data)
Year ended
August 31,
2020
2019
REVENUES
$ 2,710
$ 2,703
COST OF REVENUES (INCOME) (note 6f)
-
90
RESEARCH AND DEVELOPMENT EXPENSES
10,235
13,522
GENERAL AND ADMINISTRATIVE EXPENSES
4,232
3,722
OPERATING LOSS
11,757
14,631
FINANCIAL INCOME (note 9a)
690
1,061
FINANCIAL EXPENSES
(note 9b)
444
485
LOSS BEFORE TAXES ON INCOME
11,511
14,055
TAXES ON INCOME (note
10d)
-
300
NET LOSS FOR THE YEAR
$ 11,511
$ 14,355
UNREALIZED INCOME ON AVAILABLE FOR SALE SECURITIES
-
-
TOTAL OTHER COMPREHENSIVE INCOME
-
-
TOTAL
COMPREHENSIVE LOSS FOR THE PERIOD
$ 11,511
$ 14,355
LOSS PER SHARE OF COMMON STOCK:
BASIC AND DILUTED LOSS PER SHARE OF COMMON STOCK
$ 0.56
$ 0.82
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING BASIC AND DILUTED LOSS PER SHARE OF COMMON STOCK
20,532,347
17,454,489
The
accompanying notes are an integral part of the financial statements.
F- 3
ORAMED
PHARMACEUTICALS INC.
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
in
thousands
Common Stock
Additional
paid-in
Accumulated
other
comprehensive
Accumulated
Total stockholders’
Shares
$
capital
income
deficit
equity
In thousands
BALANCE AS OF SEPTEMBER 1, 2018
17,369
$ 207
$ 99,426
$ 702
$ (69,223 )
$ 31,112
INITIAL ADOPTION OF ASU 2016-01
(702 )
702
0
INITIAL ADOPTION OF ASC 606
1,773
1,773
SHARES ISSUED FOR SERVICES
14
1
54
55
STOCK-BASED COMPENSATION
808
808
NET LOSS
(14,355 )
(14,355 )
BALANCE AS OF AUGUST 31, 2019
17,383
208
100,288
-
(81,103 )
19,393
SHARES ISSUED FOR SERVICES
10
*
38
38
ISSUANCE OF COMMON STOCK, NET
6,270
75
23,698
23,773
EXERCISE OF WARRANTS AND OPTIONS
12
1
12
13
STOCK-BASED COMPENSATION
-
-
1,173
1,173
NET LOSS
(11,511 )
(11,511 )
BALANCE AS OF AUGUST 31, 2020
23,675
284
125,209
-
(92,614 )
32,879
*
Represents an amount of less than $1.
The
accompanying notes are an integral part of the financial statements
F- 4
ORAMED
PHARMACEUTICALS INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
In thousands
Year ended
August 31,
2020
2019
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss
$ (11,511 )
$ (14,355 )
Adjustments required to reconcile net loss to net cash provided by (used in) operating activities:
Depreciation
7
8
Exchange differences and interest on deposits and held to maturity bonds
546
(183 )
Stock-based compensation
1,173
808
Change at fair value of investments
465
437
Shares issued for services
38
55
Changes in operating assets and liabilities:
Prepaid expenses and other current assets
431
(468 )
Accounts payable, accrued expenses and related parties
(816 )
501
Deferred revenue
(2,710 )
297
Liability for employee rights upon retirement
(4 )
2
Other liabilities
(59 )
(42 )
Total net cash used in operating activities
(12,440 )
(12,940 )
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of property and equipment
(82 )
(15 )
Purchase of short-term deposits
(27,204 )
(24,990 )
Purchase of mutual funds
(3,750 )
-
Purchase of long-term deposits
-
(4,237 )
Purchase of held to maturity securities
(8,428 )
(1,357 )
Proceeds from sale of short-term deposits
40,891
38,611
Proceeds from maturity of held to maturity securities
3,200
3,250
Funds in respect of employee rights upon retirement
(1 )
(3 )
Total net cash provided by (used in) investing activities
4,626
11,259
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of common stock and warrants, net of issuance costs
23,773
-
Proceeds from exercise of warrants and options
13
-
Total net cash provided by financing activities
23,786
-
EFFECT OF EXCHANGE RATE CHANGES ON CASH
(5 )
14
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
15,967
(1,667 )
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD
3,329
4,996
CASH AND CASH EQUIVALENTS AT END OF PERIOD
$ 19,296
$ 3,329
SUPPLEMENTARY DISCLOSURE ON CASH FLOWS
Taxes paid
-
300
Interest received
$ 1,313
$ 929
The
accompanying notes are an integral part of the financial statements
F- 5
ORAMED PHARMACEUTICALS
INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
In thousands (except share and per share
data)
NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES:
a. General
1) Incorporation and operations
Oramed Pharmaceuticals Inc. (collectively
with its subsidiaries, the “Company”, unless the context indicates otherwise) was incorporated on April 12, 2002, under
the laws of the State of Nevada. From incorporation until March 3, 2006, the Company was an exploration stage company engaged in
the acquisition and exploration of mineral properties. On February 17, 2006, the Company entered into an agreement with Hadasit
Medical Services and Development Ltd. to acquire the provisional patent related to orally ingestible insulin capsule to be used
for the treatment of individuals with diabetes.
On May 14, 2007, the Company incorporated
a wholly-owned subsidiary in Israel, Oramed Ltd. (the “Subsidiary”), which is engaged in research and development.
On March 11, 2011, the Company was reincorporated
from the State of Nevada to the State of Delaware.
On July 30, 2019, the Company’s subsidiary
incorporated a wholly-owned subsidiary in Hong Kong, Oramed HK Limited (the “Hong Kong Subsidiary”). As of August 31,
2020, the Hong Kong Subsidiary has no operation.
On November 30, 2015, the Company entered
into a Technology License Agreement (the “TLA”), with Hefei Tianhui Incubation of Technologies Co. Ltd. (“HTIT”)
and on December 21, 2015, the parties entered into an Amended and Restated Technology License Agreement that was further amended
by the parties on June 3, 2016 and July 24, 2016 (the “License Agreement”). According to the License Agreement, the
Company granted HTIT an exclusive commercialization license in the territory of the People’s Republic of China, Macau and
Hong Kong (the “Territory”), related to the Company’s oral insulin capsule, ORMD-0801 (the “Product”).
Pursuant to the License Agreement, HTIT will conduct, at its own expense, certain pre-commercialization and regulatory activities
with respect to the Subsidiary’s technology and ORMD-0801 capsule, and will pay to the Subsidiary (i) royalties of 10% on
net sales of the related commercialized products to be sold by HTIT in the Territory (“Royalties”), and (ii) an aggregate
of $37,500, of which $3,000 was payable immediately, $8,000 will be paid subject to the Company entering into certain agreements
with certain third parties, and $26,500 will be paid upon achievement of certain milestones and conditions. In the event that the
Company does not meet certain conditions, the Royalties rate may be reduced to a minimum of 8%. Following the final expiration
of the Company’s patents covering the technology in the Territory in 2033, the Royalties rate may be reduced, under certain
circumstances, to 5%.
The royalty payment obligation shall apply
during the period of time beginning upon the first commercial sale of the Product in the Territory, and ending upon the later of
(i) the expiration of the last-to-expire licensed patents in the Territory; and (ii) 15 years after the first commercial sale of
the Product in the Territory (the “Royalty Term”).
The License Agreement shall remain in effect
until the expiration of the Royalty Term. The License Agreement contains customary termination provisions.
Among others, the Company’s involvement
through the product submission date will include consultancy for the pre-commercialization activities in the Territory, as well
as advisory services to HTIT on an ongoing basis.
F- 6
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share
data)
NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES
(continued):
As of August 31, 2020, the Company has
received milestone payments in an aggregate amount of $20,500 as follows: the initial payment of $3,000 was received in January
2016. Following the achievement of certain milestones, the second and third payments of $6,500 and $4,000, respectively, were received
in July 2016, the fourth milestone payment of $4,000 was received in October 2016 and the fifth milestone payment of $3,000 was
received in January 2019.
On August 21, 2020, the Company
received a letter from HTIT, disputing certain pending payment obligations of HTIT under the TLA. The payment obligation being
disputed is $4,000, out of which only an amount of $2,000 has been received and has been included in Deferred revenue in each of
the consolidated balance sheets as of the fiscal years ended August 31, 2020, and 2019. In addition, the dispute includes a payment
obligation of $2,000 for certain milestones that the Company asserts it met under the TLA subsequent to the fiscal year ended August
31, 2020. The Company wholly disputes the claims made by HTIT and has been engaged in discussions and exchanges with HTIT in an
attempt to clarify and resolve disagreements between the parties regarding milestone payments and work plan implementation.
In addition, on November 30, 2015, the
Company entered into a Stock Purchase Agreement with HTIT (the “SPA”). According to the SPA, the Company issued 1,155,367
shares of common stock to HTIT for $12,000. The transaction closed on December 28, 2015.
The License Agreement and the SPA were
considered a single arrangement with multiple deliverables. The Company allocated the total consideration of $49,500 between the
License Agreement and the SPA according to their fair value, as follows: $10,617 was allocated to the issuance of common stock
(less issuance expenses of $23), based on the quoted price of the Company’s shares on the closing date of the SPA on December
28, 2015, and $38,883 was allocated to the License Agreement. Given the Company’s continuing involvement through the expected
product submission (June 2023), amounts received relating to the License Agreement are recognized over the period from which the
Company is entitled to the respective payment, and the expected product submission date using a time-based model approach over
the periods that the fees are earned.
In July 2015, according to the letter of
intent signed between the parties or their affiliates, HTIT’s affiliate paid the Subsidiary a non-refundable amount of $500
as a no-shop fee. The no-shop fee was deferred and the related revenue is recognized over the estimated term of the License Agreement.
For the Company’s revenue recognition policy see note 1k.
F- 7
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share
data)
NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES
(continued):
2) Development and liquidity risks
The Company is engaged in research and
development in the biotechnology field for innovative pharmaceutical solutions, including an orally ingestible insulin capsule
to be used for the treatment of individuals with diabetes, and the use of orally ingestible capsules for delivery of other polypeptides,
and has not generated significant revenues from its operations. Based on the Company’s current cash resources and commitments,
the Company believes it will be able to maintain its current planned development activities and the corresponding level of expenditures
for at least the next 12 months, although no assurance can be given that the Company will not need additional funds prior to such
time. If there are unexpected increases in its operating expenses, the Company may need to seek additional financing during the
next 12 months. Successful completion of the Company’s development programs and its transition to normal operations is dependent
upon obtaining necessary regulatory approvals from the U.S. Food and Drug Administration prior to selling its products within the
United States, obtaining foreign regulatory approvals to sell its products internationally, or entering into licensing agreements
with third parties. There can be no assurance that the Company will receive regulatory approval of any of its product candidates,
and a substantial amount of time may pass before the Company achieves a level of revenues adequate to support its operations, if
at all. The Company also expects to incur substantial expenditures in connection with the regulatory approval process for each
of its product candidates during their respective developmental periods. Obtaining marketing approval will be directly dependent
on the Company’s ability to implement the necessary regulatory steps required to obtain marketing approval in the United
States and in other countries. The Company cannot predict the outcome of these activities.
In addition to the foregoing, based on
the Company’s current assessment, the Company does not expect any material impact on its development timeline and its liquidity
due to the worldwide spread of the COVID-19 virus. However, the Company is continuing to assess the effect on its operation by
monitoring the spread of COVID-19 and the actions implemented by the governments to combat the virus throughout the world.
b. Basis of presentation
The consolidated financial statements have
been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”).
c. Use of estimates in the preparation of financial
statements
The preparation of the consolidated financial
statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts
of assets and liabilities and disclosure of contingent assets and liabilities at the financial statements date and the reported
expenses during the reporting periods. Actual results could differ from those estimates.
As applicable to these consolidated financial
statements, the most significant estimates and assumptions relate to stock-based compensation, expectation of milestone payments
and to the expected product submission date for revenue recognition purposes.
F- 8
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share
data)
NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES
(continued):
d. Functional currency
The currency of the primary economic environment
in which the operations of the Company and its Subsidiaries are conducted is the U.S. dollar (“$” or “dollar”).
Therefore, the functional currency of the Company and its Subsidiaries is the dollar.
Transactions and balances originally denominated
in dollars are presented at their original amounts. Balances in foreign currencies are translated into dollars using historical
and current exchange rates for non-monetary and monetary balances, respectively. For foreign transactions and other items reflected
in the statements of operations, the following exchange rates are used: (1) for transactions - exchange rates at transaction dates
or average rates and (2) for other items (derived from non-monetary balance sheet items such as depreciation) - historical exchange
rates. The resulting transaction gains or losses are carried to financial income or expenses, as appropriate.
e. Principles of consolidation
The consolidated financial statements include
the accounts of the Company and its Subsidiaries. All inter-company transactions and balances have been eliminated in consolidation.
f. Cash equivalents
The Company considers all short-term, highly
liquid investments, which include short-term deposits with original maturities of three months or less from the date of purchase
that are not restricted as to withdrawal or use and are readily convertible to known amounts of cash, to be cash equivalents.
g. Fair value measurement:
The Company measures fair value and discloses
fair value measurements for financial assets. Fair value is based on the price that would be received to sell an asset in an orderly
transaction between market participants at the measurement date. In order to increase consistency and comparability in fair value
measurements, the guidance establishes a fair value hierarchy that prioritizes observable and unobservable inputs used to measure
fair value into three broad levels, which are described as follows:
Level 1: Quoted prices (unadjusted) in active markets that
are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level
1 inputs.
Level 2: Observable prices that are based on inputs other than
quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly.
Level 3: Unobservable inputs are used when little or no market
data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs.
As of August 31, 2020, the assets measured
at fair value are comprised of equity securities (Level 1). The fair value of held to maturity bonds as presented in note 3 was
based on a Level 2 measurement.
As of August 31, 2020, the carrying amounts
of cash equivalents, short-term deposits and accounts payable approximate their fair values due to the short-term maturities of
these instruments.
As of August 31, 2020, the carrying amounts
of long-term deposits approximate their fair values due to the stated interest rates which approximate market rates.
The amounts funded in respect of employee
rights are stated at cash surrender value which approximates its fair value.
There were no Level 3 items for the years
ended August 31, 2020 and 2019.
F- 9
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share
data)
NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES
(continued):
h. Marketable securities
1) Equity securities
In January 2016,
the Financial Accounting Standards Board (“FASB”) issued guidance which updates certain aspects of recognition, measurement,
presentation and disclosure of financial assets and financial liabilities (“ASU 2016-01”). The guidance requires entities
to recognize changes in fair value in net income rather than in accumulated other comprehensive income. The Company adopted the
provisions of this update in the first quarter of fiscal year 2019. Following the adoption, as of September 1, 2018, the Company
classified the available for sale securities (investments in equity securities of D.N.A Biomedical Solutions Ltd. (“D.N.A”),
Entera Bio Ltd. (“Entera”) and other mutual funds) to financial assets measured at fair value through profit or loss.
The Company adopted the standard using the modified retrospective method and, accordingly, reclassified the cumulative unrealized
gain from accumulated other comprehensive income to a reduction of its accumulated deficit in an amount of $702.
2) Held to maturity securities
All debt securities are classified as held-to-maturity
because the Company has the positive intent and ability to hold the securities to maturity. Held-to-maturity securities are stated
at amortized cost, adjusted for amortization of premiums and accretion of discounts to maturity. On a continuous basis, management
assesses whether there are any indicators that the value of the Company’s marketable securities may be impaired, which includes
reviewing the underlying cause of any decline in value and the estimated recovery period, as well as the severity and duration
of the decline. In the Company’s evaluation, the Company considers its ability and intent to hold these investments for a
reasonable period of time sufficient for the Company to recover its cost basis. A marketable security is impaired if the fair value
of the security is less than the carrying value of the security and such difference is deemed to be other-than temporary. To the
extent impairment has occurred, the loss shall be measured as the excess of the carrying amount of the security over the estimated
fair value of the security.
i. Concentration of credit risks
Financial instruments that subject the
Company to credit risk consist primarily of cash and cash equivalents, short and long-term deposits and marketable securities which
are deposited in major financial institutions. The Company is of the opinion that the credit risk in respect of these balances
is remote.
As of the date of
issuing these financial statements, all amounts due from HTIT with regard to the License Agreement have been received, as described
in note 1 above. However, the balance of prepaid expenses and other current assets composed of $290 was due as an expenses reimbursement
from HTIT.
F- 10
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share
data)
NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES
(continued):
j. Income taxes
1. Deferred taxes
Deferred taxes are determined utilizing
the asset and liability method based on the estimated future tax effects of differences between the financial accounting and tax
bases of assets and liabilities under the applicable tax laws. Deferred tax balances are computed using the tax rates expected
to be in effect when those differences reverse. A valuation allowance in respect of deferred tax assets is provided if, based upon
the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized.
The Company has provided a full valuation allowance with respect to its deferred tax assets. See note 10.
Regarding the Subsidiary, the recognition
is prohibited for deferred tax liabilities or assets that arise from differences between the financial reporting and tax bases
of assets and liabilities that are measured from the local currency into dollars using historical exchange rates, and that result
from changes in exchange rates or indexing for tax purposes. Consequently, the abovementioned differences were not reflected in
the computation of deferred tax assets and liabilities.
Taxes that would apply in the event of
disposal of investments in the Subsidiary have not been taken into account in computing deferred taxes, as it is the Company’s
intention to hold this investment, not to realize it.
2. Uncertainty in income tax
The Company follows a two-step approach
to recognizing and measuring uncertain tax positions. The first step is to evaluate the tax position for recognition by determining
if the weight of available evidence indicates that it is more likely than not that the position will be sustained on audit. The
second step is to measure the tax benefit as the largest amount that is more than 50% likely of being realized upon ultimate settlement.
Such liabilities are classified as long-term, unless the liability is expected to be resolved within twelve months from the balance
sheet date. The Company’s policy is to include interest and penalties related to unrecognized tax benefits within income
tax expenses.
k. Revenue recognition
The License Agreement and the SPA were
considered a single arrangement with multiple deliverables. The Company allocated the total consideration of $49,500 between the
License Agreement and the SPA according to their fair value, as follows: $10,617 was allocated to the issuance of common stock
(less issuance expenses of $23), based on the quoted price of the Company’s shares on the closing date of the SPA on December
28, 2015, and $38,883 was allocated to the License Agreement.
Under Accounting Standards Codification
(“ASC”) 605 (which was the authoritative revenue recognition guidance applied for all periods prior to September 1,
2018) given the Company’s continuing involvement through the expected product submission in June 2023, amounts received relating
to the License Agreement were recognized over the period from which the Company was entitled to the respective payment, and the
expected product submission date using a time-based model approach over the periods that the fees were earned.
F- 11
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share
data)
NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES
(continued):
On September 1, 2018, the Company adopted
Accounting Standards Update (“ASU”) 2014-09 “Revenue from Contracts with Customers (Topic 606)” (“ASC
606”), using the modified retrospective method of adoption. Under this method, the Company applied ASC 606 to the License
Agreement at the adoption date and was required to make an adjustment to the September 1, 2018 opening accumulated deficit balance.
All prior periods continue to be presented under ASC 605. The most significant impact from adopting ASC 606 was the impact of the
timing of recognition of revenue associated with the milestone payment. Under ASC 605, which was the authoritative revenue recognition
guidance applied for all periods prior to September 1, 2018, given the Company’s continuing involvement through the expected
product submission in June 2023, amounts received relating to the License Agreement were recognized over the period from which
the Company was entitled to the respective payment and the expected product submission date using a time-based model approach over
the periods that the fees were earned. However, under ASC 606, the Company is required to recognize the total transaction price
(which includes consideration related to milestones once the criteria for recognition have been satisfied) using the input method
over the period the performance obligation is fulfilled. Accordingly, once the consideration associated with a milestone is included
in the transaction price, incremental revenue is recognized immediately based on the period of time that has elapsed towards complete
satisfaction of the performance obligation. This method results in the recognition of revenue earlier than under ASC 605, and the
resulting impact was recorded as a reduction of the opening balance of accumulated deficit at September 1, 2018, as further described
below.
Under ASC 606, the Company identified a
single performance obligation in the agreement and determined that the license and services are not distinct as the license and
services are highly dependent on each other. In other words, HTIT cannot benefit from the license without the related services,
and vice versa.
Since the customer benefits from the services
as the entity performs, revenue is recognized over time through the expected product submission date in June 2023, using the input
method. The Company used the input method to measure the process for the purpose of recognizing revenue, which approximates the
straight-line attribution. The Company used significant judgment when it determined the product submission date.
Under ASC 606, the consideration that the
Company would be entitled to upon the achievement of contractual milestones, which are contingent upon the occurrence of future
events, are a form of variable consideration. When assessing the portion, if any, of such milestones-related consideration to be
included in the transaction price, the Company first assesses the most likely outcome for each milestone and excludes the consideration
related to milestones of which the occurrence is not considered the most likely outcome.
F- 12
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share
data)
NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES
(continued):
The Company then evaluates if any of the
variable consideration determined in the first step is constrained by including in the transaction price variable consideration
to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when
the uncertainty associated with the variable consideration is subsequently resolved. The Company used significant judgment
when it determined the first step of variable consideration.
The potential future royalty consideration
is also considered a form of variable consideration under ASC 606 as it is based on a percentage of potential future sales of the
Company’s products. However, the Company applies the sales-based royalty exception and accordingly will recognize the sales-based
royalty amounts at the earlier of the time (a) when the related sale has occurred and (b) the Company has fulfilled the related
performance obligation. To date, the Company has not recognized any royalty-related revenue.
As of the adoption date, the Company adjusted
its accumulated deficit by $1,773 against contract liabilities due to the effect of variable consideration.
Amounts that were allocated to the License
Agreement as of August 31, 2020 aggregated $22,383, all of which was received through the balance sheet date. Through August 31,
2020, the Company recognized revenue associated with this agreement in the aggregate amount of $12,732 (of which $2,710 was recognized
in the twelve-months period ended August 31, 2020), and deferred the remaining amount of $9,650, which is presented as a contract
liability on the condensed consolidated balance sheet.
l. Cost of revenues
Cost of revenues consists of royalties
to the IIA related to the License Agreement with HTIT. The royalties are recognized when proceeds related to the License Agreement
are received.
m. Research and development
Research and development expenses include
costs directly attributable to the conduct of research and development programs, including the cost of salaries, employee benefits,
the cost of supplies, the cost of services provided by outside contractors, including services related to the Company’s clinical
trials, clinical trial expenses and the full cost of manufacturing drug for use in research and preclinical development. All costs
associated with research and development are expensed as incurred.
Clinical trial costs are a significant
component of research and development expenses and include costs associated with third-party contractors. The Company outsources
a substantial portion of its clinical trial activities, utilizing external entities such as Clinical Research Organizations (“CROs”),
independent clinical investigators, and other third-party service providers to assist the Company with the execution of its clinical
studies. For each clinical trial that the Company conducts, clinical trial costs are expensed immediately.
F- 13
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share
data)
NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES
(continued):
n. Stock-based compensation
Equity awards granted to employees are
accounted for using the grant date fair value method. The grant date fair value is determined as follows: for stock options and
restricted stock units (“RSUs”) with an exercise price using the Black Scholes pricing model, for stock options with
market conditions using a Monte Carlo model and for RSUs with service conditions based on the grant date share price. The fair
value of share based payment awards is recognized as an expense over the requisite service period. The expected term is the length
of time until the expected dates of exercising the award and is estimated using the simplified method due to insufficient specific
historical information of employees’ exercise behavior, unless the award includes a market condition, in which case the contractual
term is used. The volatility is based on a historical volatility, by statistical analysis of the weekly share price for past periods.
The Company elected to recognize compensation cost for awards granted to employees that have a graded vesting schedule using the
accelerated method based on the multiple-option award approach. For awards with only market conditions, compensation expense is
not reversed if the market conditions are not satisfied.
When stock options are granted as consideration
for services provided by consultants and other non-employees, the transaction is accounted for based on the fair value of the consideration
received or the fair value of the stock options issued, whichever is more reliably measurable. The fair value of the options granted
to consultants and other non-employees is measured on a final basis at the end of the related service period using the Black Scholes
pricing model and is recognized over the related service period using the straight-line method.
The Company elects to account for forfeitures
as they occur.
On
September 1, 2019 the Company adopted the FASB issued ASU No. 2018-07, Compensation-Stock Compensation (Topic 718) Improvements
to Nonemployee Share-based Payments. This ASU was issued to simplify the accounting for share-based transactions by expanding the
scope of Topic 718 from only being applicable to share-based payments to employees to also include share-based payment transactions
for acquiring goods and services from nonemployees. As a result, nonemployee share-based transactions are being measured by estimating
the fair value of the equity instruments at the grant date, taking into consideration the probability of satisfying performance
conditions.
o. Loss per common share
Basic and diluted net loss per common share
are computed by dividing the net loss for the period by the weighted average number of shares of common stock outstanding for each
period. Outstanding stock options, warrants and RSUs have been excluded from the calculation of the diluted loss per share because
all such securities are anti-dilutive for all periods presented. The weighted average number of stock options, warrants and RSUs
excluded from the calculation of diluted net loss was 5,025,723 and 4,423,325 for the years ended August 31, 2020 and 2019, respectively.
F- 14
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share
data)
NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES
(continued):
p. Newly issued and recently adopted Accounting Pronouncements
1. In February 2016, the FASB issued ASU No. 2016-02,
“Leases (Topic 842)”, which supersedes the existing guidance for lease accounting, Leases (Topic 840). The new standard
requires a lessee to record assets and liabilities on its balance sheet for all leases with terms longer than 12 months. Leases
will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the lessee’s
income statement. The Company adopted this standard as of September 1, 2019 on a modified retrospective basis and will not
restate comparative periods. The Company elected the package of practical expedients permitted under the transition guidance within
the new standard which, among other things, allows the Company to carryforward the historical lease classification. The Company
made an accounting policy election to keep leases with an initial term of 12 months or less off of its balance sheet. The Company
recognized those lease payments in its statements of operations on a straight-line basis over the lease period. As of the adoption
date, the Company recognized an operating lease asset and liability of $168 and $168, respectively, as of September 1, 2019 on
its balance sheet.
2. On September 1,
2019 the Company adopted the FASB issued ASU No. 2018-07, Compensation-Stock Compensation (Topic 718) Improvements to Nonemployee
Share-based Payments. This ASU was issued to simplify the accounting for share-based transactions by expanding the scope of Topic
718 from only being applicable to share-based payments to employees to also include share-based payment transactions for acquiring
goods and services from nonemployees. As a result, nonemployee share-based transactions are being measured by estimating the fair
value of the equity instruments at the grant date, taking into consideration the probability of satisfying performance conditions.
The adoption of this slandered had no material impact on the Company’s consolidated financial statements.
q. Recently issued Accounting Pronouncements, not
yet adopted
In
June 2016, the FASB issued ASU 2016-13 “Financial Instruments—Credit
Losses—Measurement of Credit Losses on Financial Instruments.” This guidance replaces the current incurred loss impairment
methodology with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable
and supportable information to inform credit loss estimates. The guidance will be effective for the fiscal year beginning after
December 15, 2022, including interim periods within that year. The adoption of this guidance will not have a significant impact
on the Company’s consolidated financial statements.
F- 15
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share
data)
NOTE 2 - SHORT-TERM DEPOSITS:
Composition :
August 31,
2020
2019
Annual interest rate
Amount
Annual
interest rate
Amount
Dollar deposits
0.85-1.60
%
$ 11,060
1.80-3.44
%
$ 25,252
NOTE 3 - MARKETABLE SECURITIES:
a. Composition:
The Company’s marketable securities
include investments in equity securities of D.N.A, Entera, mutual funds and in held to maturity bonds.
Composition :
August 31,
2020
2019
Short-term:
D.N.A (see b below)
$ 246
$ 557
Entera (see c below)
150
304
Held to maturity bonds (see d below)
5,369
2,840
Preferred equity
481
-
Mutual funds*
3,298
-
$ 9,544
$ 3,701
Long-term:
Held to maturity bonds (see d below)
$ 3,928
$ 1,295
$ 13,472
$ 4,996
* Mutual funds include equity funds only
b. D.N.A
The D.N.A ordinary shares are traded on the Tel Aviv Stock Exchange. The fair value of those securities is measured at the
quoted prices of the securities on the measurement date.
During the years ended August 31, 2020
and 2019, the Company did not sell any of the D.N.A ordinary shares. As of August 31, 2020, the Company owns approximately 5.6%
of D.N.A’s outstanding ordinary shares.
The cost of the securities as of August
31, 2020 and 2019 is $595.
c. Entera
Entera ordinary shares have been traded
on The Nasdaq Capital Market since June 28, 2018. The Company measures the investment at fair value from such date, since it has
a readily determinable fair value (prior to such date the investment was accounted for as a cost method investment (amounting to
$1)).
F- 16
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share
data)
NOTE 3 - MARKETABLE SECURITIES (continued):
d. Held to maturity bonds
The amortized cost and estimated fair value
of held-to-maturity securities at August 31, 2020, are as follows:
August 31, 2020
Amortized cost
Gross unrealized gains (losses)
Estimated fair value
Average
yield to maturity rate
Short-term:
Commercial bonds
$ 5,295
$ (29 )
$ 5,266
2.26 %
Accrued interest
74
-
74
Long-term
3,928
56
3,984
2.20 %
$ 9,297
$ 27
$ 9,324
The amortized cost and estimated fair value
of held-to-maturity securities at August 31, 2019, are as follows:
August 31, 2019
Amortized cost
Gross unrealized gains (losses)
Estimated fair value
Average
yield to maturity rate
Short-term:
Commercial bonds
$ 2,808
$ 6
$ 2,814
2.90 %
Accrued interest
32
-
32
Long-term
1,295
4
1,299
2.47 %
$ 4,135
$ 10
$ 4,145
Held to maturity securities which will
mature during the 12 months from the balance sheet date are included in short-term marketable securities. Held to maturity securities
with maturity dates of more than one year are considered long-term marketable securities.
F- 17
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share
data)
NOTE 4 - LONG-TERM DEPOSITS AND INVESTMENT:
Composition:
August 31,
2020
2019
Lease car deposits
2
1
$ 2
$ 1
NOTE
5 - ACCOUNTS PAYABLE AND ACCRUED EXPENSES:
Composition:
August 31,
2020
2019
Accounts payable
$ 594
$ 1,337
Payroll and related accruals
54
25
Institutions
19
33
Accrued liabilities
1,032
1,146
$ 1,699
$ 2,541
NOTE 6 - COMMITMENTS:
a. In March 2011, the Subsidiary sold shares of its investee
company, Entera, to D.N.A, retaining 117,000 ordinary shares (after giving effect to a stock split by Entera in July 2018). In
consideration for the shares sold to D.N.A, the Company received, among other payments, ordinary shares of D.N.A (see also note
3).
As part of this agreement, the Subsidiary
entered into a patent transfer agreement (the “Patent Transfer Agreement”) according to which the Subsidiary assigned
to Entera all of its right, title and interest in and to a certain patent application related to the oral administration of proteins
that it has licensed to Entera since August 2010. Under this agreement, the Subsidiary is entitled to receive from Entera royalties
of 3% of Entera’s net revenues (as defined in the agreement) and a license back of that patent application for use in respect
of diabetes and influenza. As of August 31, 2020, Entera had not yet realized any revenues and had not paid any royalties to the
Subsidiary. On December 11, 2018, Entera announced that it had entered into a research collaboration and license agreement (the
“Amgen License”) with Amgen related to research of inflammatory disease and other serious illnesses. As reported by
Entera, under the terms of the Amgen License, Entera will receive a modest initial technology access fee from Amgen and will be
responsible for preclinical development at Amgen’s expense. Entera will be eligible to receive up to $270,000 in aggregate
payments, as well as tiered royalties up to mid-single digits, upon achievement of various clinical and commercial milestones if
Amgen decides to move all of these programs forward. Amgen is responsible for clinical development, manufacturing and commercialization
of any of the resulting programs. To the extent the Amgen License results in net revenues as defined in the Patent Transfer Agreement,
the Subsidiary will be entitled to the aforementioned royalties.
In addition, as part of a consulting agreement
with a third party, dated February 15, 2011, the Subsidiary is obliged to pay this third party royalties of 8% of the net royalties
received in respect of the patent that was sold to Entera in March 2011.
F- 18
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share
data)
NOTE 6 - COMMITMENTS (continued) :
b. On January 3, 2017, the Subsidiary entered into a
lease agreement for its office facilities in Israel. The lease agreement is for a period of 60 months commencing October 1, 2016.
The annual lease payment was New Israeli
Shekel (“NIS”) 119,000 ($35) from October 2016 through September 2018 and NIS 132,000 ($39) from October 2018 through
September 2021, and is linked to the increase in the Israeli consumer price index (“CPI”).
On August 2, 2020, the Subsidiary entered
into a new lease agreement for its facilities in Israel. The new lease agreement is for a period of 60 months commencing September
1, 2020. The Company has the option to extend the period in another 60 months. The annual lease payment, including management fees,
is NIS 435,000 ($130). The Company intends to terminate its current lease agreement before moving to the new office.
As security for its obligation under these
lease agreements, the Company provided a bank guarantee in an amount equal to three monthly lease payments.
c. On December 18, 2017, the Subsidiary entered into
an agreement with a vendor for the process development and production of one of its oral capsule ingredients in the amount of
$2,905 that will be paid over the term of the engagement and based on the achievement of certain development milestones, of which
$1,542 was recognized in research and development expenses through August 31, 2020.
d. On September 2, 2020 (effective as of January 15,
2020), the Subsidiary entered into a CRO Services Agreement with a third party to retain it as a CRO for the Subsidiary’s
phase 3 clinical trial for its oral insulin. As consideration for its services, the Subsidiary will pay the CRO a total amount
of $21,589 during the term of the engagement and based on achievement of certain milestones, of which $178 was recognized in research
and development expenses through August 31, 2020.
e. On September 16, 2020 (effective as of January 15,
2020), the Subsidiary entered into a CRO Services Agreement with a third party to retain it as a CRO for the Subsidiary’s
phase 3 clinical trial for its oral insulin. As consideration for its services, the Subsidiary will pay the CRO a total amount
of $12,343 during the term of the engagement and based on achievement of certain milestones, of which $400 was recognized in research
and development expenses through August 31, 2020.
f. Grants from the Israel Innovation Authority (“IIA”)
Under the terms of the Company’s
funding from the IIA, royalties of 3% are payable on sales of products developed from a project so funded, up to a maximum amount
equaling 100%-150% of the grants received (dollar linked) with the addition of interest at an annual rate based on LIBOR.
At the time the grants were received, successful
development of the related projects was not assured. The total amount that was received through August 31, 2020 was $2,207. All
grants were received before fiscal year 2020 and recorded as a reduction of Research and development expenses at that time.
The royalty expenses which are related
to the funded project were recognized in cost of revenues in the year ended August 31, 2020 and in prior periods.
g. Grants from the European Commission (“EC”)
During fiscal year 2020, the Company received
an aggregate payment of €50 from the EC under The European Innovation Council Accelerator (previously known as SME Instrument)
of the European Innovation Programme Horizon 2020.
As part of the grant terms, the Company
is required to use the proceeds from the grant in Europe. The Company intends on using the grant to explore the possibility of
running clinical trials in Europe.
F- 19
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share
data)
NOTE 7 - STOCKHOLDERS’ EQUITY:
The following are the significant capital
stock transactions that took place during the years ended August 31, 2020 and 2019:
a. In August 2019, the Company became aware of a shareholder
derivative claim and putative class action alleging, among other things, that the Second Amended and Restated 2008 Stock Incentive
Plan (the “2008 Plan”) may have terminated in 2018. However, the Company disputed these claims and believes that
the 2008 Plan does not terminate until 2026 and any suggestion to the contrary is not well-founded. For the sake of clarity and
out of an abundance of caution, the Company adopted a new option plan, which was approved at its 2019 shareholder meeting. Such
2019 Stock Incentive Plan, as amended and restated (the “2019 Plan”) originally allowed the Company to grant up to
1,000,000 options. Since the Company had granted options during the time after the old plan allegedly terminated, and out of an
abundance of caution, the Company canceled these grants and reissued the options under the new option plan in the same amounts
and under the same terms as the original grants. The cancelation and grants were approved by the Company’s board on September
11, 2019. Out of the available options under the 2019 Plan, the Company have been granted 563,646 to replace the options under
dispute as mentioned above. The cancellation of the award accompanied by the concurrent grant of a replacement award was accounted
for as modification of the terms of the cancelled award. Since the replacement award was given under the same terms as the cancelled
award, no incremental compensation cost was recognized. On August 3, 2020, the stockholders of the Company adopted the amended
and restated 2019 Plan which increased the shares available to grant under the plan by an additional 2,000,000 to 3,000,000 options.
b. On September 5, 2019, the Company entered into an
Equity Distribution Agreement (the “Sales Agreement”), pursuant to which the Company may, from time to time and at
the Company’s option, issue and sell shares of Company common stock having an aggregate offering price of up to $15,000,
through a sales agent, subject to certain terms and conditions. Any shares sold will be sold pursuant to the Company’s effective
shelf registration statement on Form S-3 including a prospectus and prospectus supplement, each dated February 10, 2020 (which
superseded a prior registration statement, prospectus and prospectus supplement that related to shares sold under the Sales Agreement).
The Company will pay the sales agent a cash commission of 3.0% of the gross proceeds of the sale of any shares sold through the
sales agent under the Sales Agreement. As of August 31, 2020, 839,357 shares were issued under the Sales Agreement for aggregate
net proceeds of $3,879.
c. On February 27, 2020, the Company entered into an
underwriting agreement (“Agreement”) with National Securities Corporation (“Underwriter”), in connection
with a public offering (“Offering”) of 5,250,000 shares of the Company’s common stock, at an offering price
of $4.00 per share. Under the terms of the Agreement, the Company granted the Underwriter a 45-day option to purchase from the
Company up to an additional 787,500 shares of common stock at the public offering price (“Over-Allotment Option”).
In connection with the Offering, the Company also agreed to issue to the Underwriter, or its designees, warrants (“Underwriter’s
Warrants”), to purchase up to an aggregate of 7% of the shares of common stock sold in the Offering (including any additional
shares sold during the 45-day option period), at an exercise price of $4.80 per share. The Underwriter’s Warrants issued
in the Offering will be exercisable at any time and from time to time, in whole or in part, commencing six months from issuance
for a period of three years from the date of issuance. The closing of the sale of the Offering occurred on March 2, 2020. On April
9, 2020, the Company issued 180,561 shares of Common Stock and 12,640 Underwriter’s Warrants pursuant to a partial exercise
by the Underwriter of the Over-Allotment Option (“Partial Over-Allotment Option Exercise”). The net proceeds to the
Company from the Offering, including from the Partial Over-Allotment Option Exercise, after deducting the underwriting discount
and the Company’s estimated Offering expenses were $19,894.
d. As of August 31, 2020, the Company had outstanding
warrants exercisable commencing January 6, 2019 for 3,407,820 shares of common stock at exercise prices ranging from $4.80 to
$7.8125 per share and expiring from January 6, 2022 to April 10, 2029.
The following table presents the warrant
activity for the years ended August 31, 2020 and 2019:
Year ended
August 31,
2020
2019
Warrants
Weighted-
Average Exercise Price
Warrants
Weighted-
Average Exercise Price
Warrants outstanding at beginning of year
3,007,680
$ 7.27
3,007,680
$ 7.27
Issued
400,140
$ 4.77
-
$ -
Exercised
-
$ -
-
$ -
Expired
-
$ -
-
$ -
Warrants outstanding at end of year
3,407,820
$ 6.98
3,007,680
$ 7.27
Warrants exercisable at end of year
3,407,820
$ 6.98
3,007,680
$ 7.27
F- 20
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share
data)
NOTE 8 - STOCK-BASED COMPENSATION:
The Company makes awards only under the
2019 Plan, under which, the Company had reserved a pool of 3,000,000 shares of the Company’s common stock which may be issued
at the discretion of the Company’s Board of Directors from time to time. Under this 2019 Plan, each option is exercisable
into one share of common stock of the Company. The options may be exercised after vesting and in accordance with vesting schedules
which will be determined by the Board of Directors for each grant. The maximum term of the options is 10 years.
The following are the significant stock
options transactions with employees, board members and non-employees made during the years ended August 31, 2020 and 2019:
a. On February 26, 2019, the Company granted options
to purchase an aggregate of 360,000 shares of common stock of the Company at an exercise price of $3.16 per share (equivalent
to the closing price of the Company’s common stock on the date of grant) as follows: 196,500 to the CEO; 104,000 to the
CSO; and 59,500 to employees of the Subsidiary. 49,125, 26,000 and 14,875 options of the CEO, CSO and the employees, respectively,
were vested and the remainder will vest in three equal annual installments on each of December 31, 2020, 2021 and 2022. These
options expire on February 26, 2029. The fair value of all these options on the date of grant was $731, using the Black Scholes
option-pricing model and was based on the following assumptions: stock price of $3.16; dividend yield of 0% for all years; expected
volatility of 69.05%; risk-free interest rates of 2.54%; and expected term of 6.25 years.
b.
On April 10, 2019 and April 15, 2019, the Company granted options to its directors to purchase an aggregate of 30,000 shares of common stock of the Company at an exercise price of $4.17 and $4.13 per share, respectively (equivalent to the closing price of the Company’s common stock on the date of grant). 20,000 of such options vested immediately and the remaining 10,000 options vested on December 31, 2019. The fair value of all these options on the date of grant was $64, using the Black Scholes option-pricing model and was based on the following assumptions: stock price of $4.13 and $4.17, respectively; dividend yield of 0% for all years; expected volatility of 54.64% and 66.40%, respectively; risk-free interest rates of 2.37% and 2.28%, respectively; and expected term of 5 and 5.5 years, respectively.
c. On June 17, 2019, the Company granted options to its
chief financial officer to purchase an aggregate of 33,146 shares of common stock of the Company at an exercise price of $3.55
per share (equivalent to the closing price of the Company’s common stock on the date of grant). 5,396 of such options vested
will vest on December 31, 2019 and the remaining 27,750 will vest in 3 equal installments on each of December 31, 2020, December
31, 2021 and December 31, 2022. The fair value of all these options on the date of grant was $74, using the Black Scholes option-pricing
model and was based on the following assumptions: stock price of $3.55; dividend yield of 0% for all years; expected volatility
of 67.79%; risk-free interest rates of 2.03%; and expected term of 6.25 years.
d.
On September 11, 2019, the Company granted options to its chief business and operation officer to purchase an aggregate of 100,000 shares of common stock of the Company at an exercise price of $3.69 per share (equivalent to the closing price of the Company’s common stock on the date of grant). The options shall vest in 16 equal installments of 6,250 on the first day of every three months period beginning November 1, 2019. As of August 31, 2020, 25,000 of such options are vested. The options expire on September 11, 2029. The fair value of all these options on the date of grant was $224, using the Black Scholes option-pricing model and was based on the following assumptions: stock price of $3.69; dividend yield of 0% for all years; expected volatility of 65.60%; risk-free interest rates of 1.89%; and expected term of 6.14 years.
e.
On September 11, 2019, the Company granted options to its chief business and operation officer to purchase an aggregate of 100,000 shares of common stock of the Company at an exercise price of $3.69 per share (equivalent to the closing price of the Company’s common stock on the date of grant). The options shall vest in 4 installments upon achievement of certain performance conditions. As of August 31, 2020, no such options are vested. The options expire on September 11, 2029. The fair value of all these options on the date of grant was $127, using the Black Scholes option-pricing model and was based on the following assumptions: stock price of $3.69; dividend yield of 0% for all years; expected volatility of 67.96%; risk-free interest rates of 1.68%; expected term of 6.91 years; and the probability that such performance conditions will occur.
f. On January 8, 2020, the Company granted options to
its directors to purchase an aggregate of 100,000 shares of common stock of the Company at an exercise price of $4.80 per share
(equivalent to the closing price of the Company’s common stock on the date of grant). The options shall vest in three equal
installments on each of December 31, 2020, December 31, 2021 and December 31, 2022. The options expire on January 8, 2030. The
fair value of all these options on the date of grant was $278, using the Black Scholes option-pricing model and was based on the
following assumptions: stock price of $4.80; dividend yield of 0% for all years; expected volatility of 62.55%; risk-free interest
rates of 1.67%; and expected term of 5.99.
F- 21
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share
data)
NOTE 8 - STOCK-BASED COMPENSATION (continued):
g. On January 8, 2020, the Company granted options to
purchase an aggregate of 290,000 shares of common stock of the Company at an exercise price of $4.80 per share (equivalent to
the closing price of the Company’s common stock on the date of grant) as follows: 190,000 to the CEO and 100,000 to the
CSO. The options will vest in four equal annual installments, on each of December 31, 2020, 2021, 2022 and 2023. These options
expire on January 8, 2030. The fair value of all these options on the date of grant was $868, using the Black Scholes option-pricing
model and was based on the following assumptions: stock price of $4.80; dividend yield of 0% for all years; expected volatility
of 67.87%; risk-free interest rates of 1.67%; and expected term of 6.24 years.
h. Options to employees, directors and non-employees
The fair value of each option grant is
estimated on the date of grant using the Black Scholes option-pricing model or Monte Carlo model with the following range of assumptions:
For options granted
in the year ended
August 31,
2020
2019
Expected option life (years)
5.74-6.24
5-6.25
Expected stock price volatility (%)
57.77-68.14
54.64-69.05
Risk free interest rate (%)
1.67-1.89
2.03-2.54
Expected dividend yield (%)
0.0
0.0
A summary of the status of the stock options
granted to employees and directors as of August 31, 2020, and 2019, and changes during the years ended on those dates, is presented
below:
Year ended
August 31,
2020
2019
Number
of
options
Weighted
average
exercise
price
Number
of
options
Weighted
average
exercise
price
$
$
Options outstanding at beginning of year
1,264,645
6.11
1,208,634
7.25
Changes during the year:
Granted
943,646
3.98
423,146
3.26
Forfeited
(392,646 )
3.79
(136,084 )
5.79
Expired
(206,243 )
6.02
(231,051 )
7.07
Exercised
(12,253 )
1.00
-
Options outstanding at end of year
1,597,149
5.47
1,264,645
6.11
Options exercisable at end of year
687,024
709,383
Weighted average fair value of options granted during the year
$ 2.79
$ 2.06
Expenses recognized in respect of stock
options granted to employees and directors, for the years ended August 31, 2020 and 2019 were $1,086 and $791, respectively.
The total intrinsic value of employees’
options exercised during the year ended August 31, 2020 was $27. None of the options were exercised by employees during the year
ended August 31, 2019.
F- 22
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share
data)
NOTE 8 - STOCK-BASED COMPENSATION (continued):
The following table
presents summary information concerning the options granted to employees and directors outstanding as of August 31, 2020:
Exercise
prices
Number outstanding
Weighted
Average
Remaining
Contractual
Life
Weighted
average
exercise
price
$
Years
$
1.00 to 6.00
1,117,980
8.06
3.98
6.23 to 7.88
225,251
6.82
7.73
8.14 to 12.45
253,918
5.77
10.01
1,597,149
7.52
5.47
687,024 of options granted to employees
and directors that were outstanding as of August 31, 2020, were also exercisable as of August 31, 2020.
As of August 31, 2020, there were $1,167
of unrecognized compensation costs related to non-vested options previously granted to employees and directors. The unrecognized
compensation costs are expected to be recognized over a weighted average period of 2.1 years.
A summary of the status of the stock options
granted to non-employees outstanding as of August 31, 2020 and 2019, and changes during the years ended on those dates, is presented
below:
Year ended
August 31,
2020
2019
Number
of
options
Weighted
average
exercise
price
Number
of
options
Weighted
average
exercise
price
$
$
Options outstanding at beginning of year
47,152
9.51
55,486
6.71
Changes during the year:
Granted
56,000
4.21
-
-
Exercised
-
-
-
-
Forfeited
-
-
-
-
Expired
-
-
(8,334 )
9.12
Options outstanding at end of year
103,152
6.64
47,152
9.51
Options exercisable at end of year
65,152
5.58
41,992
6.32
Weighted average fair value of options granted during the year
$ 2.47
-
The Company recorded stock-based compensation
of $87 and $22 during the years ended August 31, 2020 and 2019, respectively, related to non-employees’ awards.
None of the options were exercised by non-employees
during the years ended August 31, 2020 and 2019.
F- 23
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share
data)
NOTE 8 - STOCK-BASED COMPENSATION (continued):
The following table
presents summary information concerning the options granted to non-employees outstanding as of August 31, 2020:
Range of
exercise
prices
Number outstanding
Weighted
Average
Remaining
Contractual
Life
Weighted
Average
Exercise
Price
$
Years
$
3.74-5.08
56,000
9.30
4.22
6.00-7.36
47,152
5.21
6.29
103,152
7.43
5.16
65,152 options granted to non-employees
that were outstanding as of August 31, 2020, were also exercisable as of August 31, 2019.
As of August 31, 2020, there were $51 of
unrecognized compensation costs related to non-vested options previously granted to non-employees. The unrecognized compensation
costs are expected to be recognized over a weighted average period of 1.5 years.
i. Restricted stock units
The following table summarizes the activities
for unvested RSUs granted to employees and directors for the years ended August 31, 2020 and 2019:
Year ended
August 31,
2020
2019
Number of RSUs
Unvested at the beginning of period
164,636
165,796
Vested and issued
-
(290 )
Forfeited
-
(870 )
Outstanding at the end of the period
164,636
164,636
Vested and unissued
164,636
164,636
The Company recorded compensation income
related to RSUs of $5 for the year ended August 31, 2019, related to RSU awards. During the year ended August 31, 2020, the Company
did not record expense or income related to RSU.
As of August 31, 2020, there are no unrecognized
compensation costs related to RSUs.
F- 24
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share
data)
NOTE 9 - FINANCIAL INCOME AND EXPENSES
a. Financial income
Year ended
August 31,
2020
2019
Income from interest on deposits
$ 552
$ 909
Income from interest on corporate bonds
138
152
$ 690
$ 1,061
b. Financial expenses
Year ended
August 31,
2020
2019
Exchange rate differences
$ 6
$ 14
Bank and broker commissions
6
4
Loss (gain) from securities, net
432
436
Other
-
31
$ 444
$ 485
NOTE 10 - TAXES
ON INCOME:
Taxes on income included in the consolidated
statements of operations represent current taxes due to taxable income of the Company and its Subsidiary.
a. Corporate taxation in the U.S.
The applicable corporate tax rate for the
Company is 21% following the U.S. Tax Cuts and Jobs Act (the “TCJA”), excluding state tax and local tax. On December
22, 2017, the TCJA was signed into law, which among other changes reduced the federal corporate income tax rate from 35% to 21%,
effective January 1, 2018.
As
of August 31, 2020, the Company has an accumulated tax loss carryforward of approximately $15,880 (as of August 31, 2019, $13,013).
Under U.S. tax laws, subject to certain limitations, carryforward tax losses originating in tax years beginning after January
1, 2018 , have no expiration date, but they are limited to 80% of the company's taxable income
in any given tax year. carryforward tax losses originating in tax years beginning prior to January 1, 2018 , expire
20 years after the year in which incurred. In the case of the Company, subject to potential limitations in accordance with the
relevant law, the net loss carryforward will expire in the years 2027 through 2039.
b. Corporate taxation in Israel:
The Subsidiary is taxed in accordance with
Israeli tax laws. The corporate tax rates applicable to 2020 and 2019 is 23%.
As of August 31, 2020, the Subsidiary has
an accumulated tax loss carryforward of approximately $57,900 (as of August 31, 2019, approximately $44,469). Under the Israeli
tax laws, carryforward tax losses have no expiration date.
F- 25
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share
data)
NOTE 10 - TAXES ON INCOME (continued):
c. Deferred income taxes:
August 31,
2020
2019
In respect of:
Net operating loss carryforward
$ 16,652
$ 13,239
Research and development expenses
2,740
2,999
Less - valuation allowance
(19,392 )
(16,238 )
Net deferred tax assets
$ -
$ -
Deferred taxes are determined based on
temporary differences between financial reporting and tax bases of assets and liabilities and are measured using the enacted tax
rates and laws that will be in effect when the differences are expected to reverse.
Realization of deferred tax assets is dependent
upon sufficient future taxable income during the period that deductible temporary differences and carryforwards are expected to
be available to reduce taxable income. As the achievement of required future taxable income is uncertain, the Company recorded
a full valuation allowance.
The reduction of the tax rate and TCJA
had no impact on the net deferred taxes of the Company.
d. Loss before taxes on income and income taxes included
in the income statements of operations:
Year ended
August 31,
2020
2019
Loss before taxes on income:
U.S.
$ 2,868
$ 2,283
Outside U.S.
8,643
11,772
$ 11,511
$ 14,055
Taxes on income (tax benefit):
Current:
U.S.
-
-
Outside U.S.
-
300
$ -
$ 300
Taxes on income
of $300 in the year ended August 31, 2019 resulted from withholding tax deducted from HTIT milestones payments, which were received
during the year ended August 31, 2019, according to the License Agreement. As of August 31, 2020, the Company did not expect to
reach taxable income in the 5 years following the balance sheet date, and therefore recognized this amount as taxes on income.
F- 26
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share
data)
NOTE 10 - TAXES ON INCOME (continued):
e. Reconciliation of the statutory tax benefit to
effective tax expense
Following is a reconciliation of the theoretical
tax expense, assuming all income is taxed at the regular tax rates applicable to companies in the United States, and the actual
tax expense:
Year ended
August 31,
2020
2019
Loss before income taxes as reported in the consolidated statement of comprehensive loss
$ (11,511 )
$ (14,055 )
Statutory tax benefit
(2,417 )
(2,952 )
Increase in income taxes resulting from:
Change in the balance of the valuation allowance for deferred tax
3,154
3,356
Disallowable deductions
135
86
Influence of different tax rate applicable to the Subsidiary and changes in tax rates from previous years
(872 )
(490 )
Withholding tax, see note 10d above
-
300
Uncertain tax position
-
-
Taxes on income for the reported year
$ -
$ 300
f. Uncertainty in Income Taxes
ASC Topic 740, “Income Taxes”
requires significant judgment in determining what constitutes an individual tax position as well as assessing the outcome of each
tax position. Changes in judgment as to recognition or measurement of tax positions can materially affect the estimate of the effective
tax rate and consequently, affect the operating results of the Company. The Company recognizes interest and penalties related to
its tax contingencies as income tax expense.
The following table summarizes the activity
of the Company unrecognized tax benefits:
Year ended
August 31,
2020
2019
Balance at Beginning of Year
$ 11
$ 11
Decrease in uncertain tax positions for the current year
-
-
Balance at End of Year
$ 11
$ 11
The Company does not expect unrecognized
tax expenses to change significantly over the next 12 months.
The Company is subject to U.S. Federal
income tax examinations for the tax years of 2016 through 2018.
The Subsidiary is subject to Israeli income
tax examinations for the tax years of 2014 through 2019.
F- 27
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share
data)
NOTE 10 - TAXES ON INCOME (continued):
g. Valuation Allowance Rollforward
Year ended
August 31,
Balance at beginning of period
Additions
Balance at end of period
Allowance in respect of carryforward tax losses:
Year ended August 31, 2020
$ 16,238
$ 3,154
$ 19,392
Year ended August 31, 2019
12,882
3,356
16,238
NOTE
11 - RELATED PARTIES - TRANSACTIONS:
a. During each of the fiscal years of 2020 and 2019,
the Company paid to directors $95 and $100, respectively, as directors’ fees.
b. On July 1, 2008, the Subsidiary entered into two consulting
agreements with KNRY Ltd. (“KNRY”), an Israeli company owned by the CSO, whereby the CEO and the CSO, through KNRY,
provide services to the Company (the “Consulting Agreements”). The Consulting Agreements are both terminable by either
party upon 140 days, prior written notice. The Consulting Agreements, as amended, provide that KNRY will be reimbursed for reasonable
expenses incurred in connection with performance of the Consulting Agreements and that the monthly consulting fee paid to the
CEO and the CSO is NIS 127,570 ($38) and NIS 92,522 ($28), respectively.
In addition to the Consulting Agreements,
based on a relocation cost analysis prepared by consulting company ORI - Organizational Resources International Ltd., the Company
pays for certain direct costs, related taxes and expenses incurred in connection with the relocation of the CEO to New York. During
fiscal 2020 and 2019 such relocation expenses totaled $516 and $486, respectively.
c. Balances with related parties:
August 31,
2020
2019
Accounts payable and accrued expenses - KNRY
$ 90
$ 64
d. Expenses to related parties:
Year ended
August 31,
2020
2019
KNRY
$ 766
$ 730
Nadav Kidron (CEO)
$ 801
785
F- 28
All other schedules for which provision
is made in the applicable accounting regulations of the SEC are not required under the related instructions, or are inapplicable,
and therefore have been omitted.
(b) Exhibits
3.1*
Composite Copy of Certificate of Incorporation, as amended as
of January 22, 2013, corrected February 8, 2013, as amended as of July 25, 2014, corrected September 5, 2017 and as further
amended as of August 3, 2020.
3.2*
Composite Copy of Certificate of Incorporation, as amended as
of January 22, 2013, corrected February 8, 2013, as amended as of July 25, 2014, corrected September 5, 2017 and as further
amended as of August 3, 2020 (marked copy).
3.3
Amended and Restated By-laws (incorporated by reference from our current report on Form 8-K filed February 1, 2013).
4.1
Specimen Common Stock Certificate (incorporated by reference from our registration statement on Form S-1 filed February 1, 2013).
4.2
Form of Common Stock Purchase Warrant (incorporated by reference from our current report on Form 8-K filed July 5, 2018).
4.3
Form of Underwriter’s Warrant (incorporated by reference from our current report on Form 8-K filed February 28, 2020).
4.4*
Description of Securities.
10.1+
Consulting Agreement by and between Oramed Ltd. and KNRY, Ltd., entered into as of July 1, 2008, for the services of Nadav Kidron (incorporated by reference from our current report on Form 8-K filed July 2, 2008).
10.2+
Amendment, dated July 13, 2013, to Consulting Agreement by and between Oramed Ltd. and KNRY, Ltd., entered into as of July 1, 2008 for the services of Nadav Kidron (incorporated by reference from our annual report on Form 10-K filed November 14, 2014).
10.3+
Amendment, dated November 13, 2014, to Consulting Agreements by and between Oramed Ltd. and KNRY, Ltd., entered into as of July 1, 2008, for the services of Nadav Kidron and Miriam Kidron (incorporated by reference from our annual report on Form 10-K filed November 14, 2014).
53
10.4+
Amendment, dated July 21, 2015, to Consulting Agreements by and between Oramed Ltd. and KNRY, Ltd., entered into as of July 1, 2008, for the services of Nadav Kidron (incorporated by reference from our annual report on Form 10-K filed November 25, 2015).
10.5+
Amendment, dated June 27, 2016, to Consulting Agreements by and between Oramed Ltd. and KNRY, Ltd., entered into as of July 1, 2008, for the services of Nadav Kidron (incorporated by reference from our annual report on Form 10-K filed November 25, 2016).
10.6+
Amendment,
dated November 28, 2016, to Consulting Agreements by and between Oramed Ltd. and KNRY, Ltd., entered into as of July 1, 2008,
for the services of Nadav Kidron (incorporated by reference from our quarterly report on Form 10-Q filed January 11, 2017).
10.7+
Consulting Agreement by and between Oramed Ltd. and KNRY, Ltd., entered into as of July 1, 2008, for the services of Miriam Kidron (incorporated by reference from our current report on Form 8-K filed July 2, 2008).
10.8+
Amendment, dated July 13, 2013, to Consulting Agreement by and between Oramed Ltd. and KNRY, Ltd., entered into as of July 1, 2008 for the services of Miriam Kidron (incorporated by reference from our annual report on Form 10-K filed November 14, 2014).
10.9+
Amendment, dated July 21, 2015, to Consulting Agreements by and between Oramed Ltd. and KNRY, Ltd., entered into as of July 1, 2008, for the services of Miriam Kidron (incorporated by reference from our annual report on Form 10-K filed November 25, 2015).
10.10+
Amendment, dated June 27, 2016, to Consulting Agreements by and between Oramed Ltd. and KNRY, Ltd., entered into as of July 1, 2008, for the services of Miriam Kidron (incorporated by reference from our annual report on Form 10-K filed November 25, 2016).
10.11+
Amendment, dated June 30, 2017, to Consulting Agreements by and between Oramed Ltd. and KNRY, Ltd., entered into as of July 1, 2008, for the services of Miriam Kidron (incorporated by reference from our annual report on Form 10-K filed November 29, 2017).
10.12+
Amendment, dated January 10, 2020, to Consulting Agreements by and between Oramed Ltd. and KNRY, Ltd., entered into as of July 1, 2008, for the services of Miriam Kidron (incorporated by reference from our quarterly report on Form 10-Q filed April 6, 2020).
10.13+
Oramed Pharmaceuticals Inc. Second Amended and Restated 2008 Stock Incentive Plan (incorporated by reference from our definitive proxy statement on Schedule 14A filed August 4, 2016).
10.14+
Form of Restricted Stock Unit Notice and Restricted Stock Unit Agreement (incorporated by reference from our annual report on Form 10-K filed November 14, 2014).
54
10.15+
Form of Restricted Stock Unit Notice and Restricted Stock Unit Agreement between the Company and the CSO or CEO (incorporated by reference from our annual report on Form 10-K filed November 29, 2017).
10.16+
Form of Notice of Stock Option Award and Stock Option Award Agreement (incorporated by reference from our current report on Form 8-K filed July 2, 2008).
10.17+
Oramed Pharmaceuticals Inc. 2019 Stock Incentive Plan (incorporated by reference from our definitive proxy statement on Schedule 14A filed August 6, 2019).
10.18+
Oramed Pharmaceuticals Inc. Amended and Restated 2019 Stock Incentive Plan (incorporated by reference from our definitive proxy statement on Schedule 14A filed June 30, 2020).
10.19+
Form of Notice of Stock Option Award and Stock Option Award Agreement (incorporated by reference from our annual report on Form 10-K filed November 27, 2019).
10.20+
Employment Agreement, dated May 16, 2019, by and between Oramed Ltd. and Avraham Gabay (incorporated by reference from our current report on Form 8-K filed May 16, 2019).
10.21+
First Amendment, dated December 19, 2019, to Employment Agreement, entered into as of May 16, 2019, by and between Oramed Ltd. and Avraham Gabay (incorporated by reference from our quarterly report on Form 10-Q filed January 9, 2020).
10.22+
Clinical Trial Agreement, dated September 11, 2011, between Oramed Ltd., Hadasit Medical Research Services and Development Ltd., Miriam Kidron and Daniel Schurr (incorporated by reference from our annual report on Form 10-K/A filed December 21, 2012).
10.23+
Clinical Trial Agreement, dated July 8, 2009, between Oramed Ltd., Hadasit Medical Research Services and Development Ltd., Miriam Kidron and Itamar Raz (incorporated by reference from our current report on Form 8-K filed July 9, 2009).
10.24
Agreement, dated January 7, 2009, between Oramed Pharmaceuticals Inc. and Hadasit Medical Research Services and Development Ltd. (incorporated by reference from our current report on Form 8-K filed January 7, 2009).
10.25
Patent Transfer Agreement, dated February 22, 2011, between Oramed Ltd. and Entera Bio Ltd. (incorporated by reference from our registration statement on Form S-1 filed March 25, 2011).
55
10.26+
Representative Form of Indemnification Agreements between Oramed Pharmaceuticals Inc. and each of our directors and officers (incorporated by reference from our quarterly report on Form 10-Q filed January 9, 2020).
10.27+
Employment Agreement, dated August 18, 2019, between Oramed
Ltd. and Joshua Hexter (incorporated by reference from our annual report on Form 10-K filed November 27, 2019).
10.28
Securities Purchase Agreement, dated November 30, 2015, between Oramed Pharmaceuticals, Inc. and Hefei Tianhui Incubator of Technologies Co., Ltd. (incorporated by reference from Schedule 13D/A filed by Nadav Kidron on December 29, 2015).
10.29
Amended and Restated Technology License Agreement, dated December 21, 2015, between Hefei Tianhui Incubator of Technologies Co., Ltd., Oramed Pharmaceuticals, Inc. and Oramed Ltd. (Confidential treatment has been granted for portions of this document. Incorporated by reference from our quarterly report on Form 10-Q filed January 13, 2016).
10.30
Amendment
to the Amended and Restated Technology License Agreement, dated June 3, 2016, between Hefei Tianhui Incubator of Technologies
Co., Ltd., Oramed Pharmaceuticals, Inc. and Oramed Ltd. (Confidential treatment has been requested for portions of this
document. The confidential portions will be omitted and filed separately, on a confidential basis, with the Securities and
Exchange Commission) (incorporated by reference from our annual report on Form 10-K filed November 25, 2016).
10.31
Amendment
to the Amended and Restated Technology License Agreement, dated July 24, 2016, between Hefei Tianhui Incubator of
Technologies Co., Ltd., Oramed Pharmaceuticals, Inc. and Oramed Ltd. (Confidential treatment has been requested for portions
of this document. The confidential portions will be omitted and filed separately, on a confidential basis, with the
Securities and Exchange Commission) (incorporated by reference from our annual report on Form 10-K filed November 25,
2016).
10.32
Service Agreement, dated as of June 3, 2016, between Oramed Ltd. and XERTECS GmbH (Confidential treatment has been granted for portions of this document. The confidential portions have been omitted and filed separately, on a confidential basis, with the Securities and Exchange Commission) (incorporated by reference from our annual report on Form 10-K filed November 25, 2016).
10.33
General Technical Agreement between Oramed Ltd. and Premas Biotech Pvt. Ltd., dated July 24, 2016 (Confidential treatment has been granted for portions of this document. The confidential portions have been omitted and filed separately, on a confidential basis, with the Securities and Exchange Commission) (incorporated by reference from our annual report on Form 10-K filed November 25, 2016).
56
10.34
Equity Distribution Agreement, dated September 5, 2019, between Oramed Pharmaceuticals Inc. and Canaccord Genuity LLC (incorporated by reference from our current report on Form 8-K filed September 5, 2019).
10.35
Amendment to the Equity Distribution Agreement, dated February 10, 2020, by and between the Company and Canaccord Genuity LLC (incorporated by reference from our quarterly report on Form 10-Q filed April 6, 2020).
10.36
Clinical Research Organization Services Agreement, dated February 14, 2018 and effective as of November 1, 2017, between Oramed Ltd. and Integrium, LLC (Confidential treatment has been granted for portions of this document. The confidential portions have been omitted and filed separately, on a confidential basis, with the Securities and Exchange Commission.) (incorporated by reference from our quarterly report on Form 10-Q filed April 9, 2018).
10.37
Amendment #1 to Clinical Research Organization Services Agreement Protocol # ORA-D-015 between Oramed, Inc. and Integrium, LLC (incorporated by reference from our quarterly report on Form 10-Q filed July 10, 2019).
10.38
Amendment #2 to Clinical Research Organization Services Agreement Protocol # ORA-D-015 between Oramed, Inc. and Integrium, LLC (incorporated by reference from our quarterly report on Form 10-Q filed July 10, 2019).
10.39
Clinical Research Organization Services Agreement, dated September 2, 2020 and effective as of January 15, 2020, between Oramed Ltd. and Integrium, LLC (incorporated by reference from our Form 8-K filed September 9, 2020).
10.40
Clinical Research Organization Services Agreement, dated September 16, 2020 and effective as of January 15, 2020, between Oramed Ltd. and Integrium, LLC (incorporated by reference from our Form 8-K filed September 18, 2020).
21.1
Subsidiaries (incorporated by reference from our annual report on Form 10-K filed November 27, 2019).
23.1*
Consent of Kesselman & Kesselman, Independent Registered Public Accounting Firm.
31.1*
Certification Statement of the Chief Executive Officer pursuant to Rule 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as amended.
31.2*
Certification Statement of the Chief Financial Officer pursuant to Rule 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as amended.
57
32.1**
Certification Statement of the Principal Executive Officer pursuant to 18 U.S.C. Section 1350.
32.2**
Certification Statement of the Principal Financial Officer pursuant to 18 U.S.C. Section 1350.
101.1*
The following financial statements from the Company’s annual report on Form 10-K for the year ended August 31, 2020, formatted in XBRL (eXtensible Business Reporting Language): (i) Consolidated Balance Sheets, (ii) Consolidated Statements of Comprehensive Loss, (iii) Consolidated Statements of Changes in Stockholders’ Equity, (iv) Consolidated Statements of Cash Flows and (v) the Notes to Consolidated Financial Statements, tagged as blocks of text and in detail.
* Filed herewith.
** Furnished herewith.
+ Management contract or compensation plan.
ITEM 16. FORM 10-K SUMMARY.
None.
58
SIGNATURES
Pursuant to the requirements of Section
13 or 15 (d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
ORAMED PHARMACEUTICALS INC.
/s/ NADAV KIDRON
Nadav Kidron,
President and Chief Executive Officer
Date: November 24, 2020
59
Pursuant to the requirements of the Securities
and Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities
and on the dates indicated.
/s/
NADAV KIDRON
November
24, 2020
Nadav
Kidron,
President
and Chief Executive Officer and Director
(principal
executive officer)
/s/
AVRAHAM GABAY
November
24, 2020
Avraham
Gabay,
Chief
Financial Officer
(principal
financial and accounting officer)
/s/
AVIAD FRIEDMAN
November
24, 2020
Aviad
Friedman,
Director
/s/
MIRIAM KIDRON
November
24, 2020
Miriam
Kidron,
Director
/s/
ARIE MAYER
November
24, 2020
Arie
Mayer,
Director
/s/
KEVIN RAKIN
November
24, 2020
Kevin
Rakin,
Director
/s/
LEONARD SANK
November
24, 2020
Leonard
Sank,
Director
/s/
GAO XIAOMING
November
24, 2020
Gao
Xiaoming,
Director
60