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, 2021. Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and
procedures are effective.
27
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, 2021 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, 2021 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, 2021 that have materially affected, or are
reasonable likely to materially affect, our internal control over financial reporting.
ITEM 9B. OTHER INFORMATION.
Not applicable.
ITEM 9C. DISCLOSURE REGARDING FOREIGN
JURISDICTIONS THAT PREVENT INSPECTIONS.
Not applicable.
28
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
47
President, Chief Executive Officer and Director
Miriam Kidron
81
Chief Scientific Officer and Director
David Silberman
38
Chief Financial Officer, Treasurer and Secretary
Joshua Hexter
51
Chief Operating & Business Officer
Michael Rabinowitz
56
Chief Commercial Officer
Aviad Friedman
50
Director
Arie Mayer
66
Director
Kevin Rakin
61
Chairman, Director
Leonard Sank
57
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.
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.
29
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. David Silberman
was appointed Chief Financial Officer, Treasurer and Secretary effective July 2021. Prior to his appointment, from April
2018 until May 2021, Mr. Silberman served as a Corporate Financial Planning and Analysis associate director and director at Teva Pharmaceutical
Industries Ltd., a global pharmaceutical company, committed to helping patients around the world to access affordable medicines and benefit
from innovations to improve their health. From 2014 to 2018, Mr. Silberman served as Global Internal Audit Senior Manager at Teva Pharmaceutical
Industries Ltd.. From 2009 to 2014, Mr. Silberman provided internal audit and risk management services in the advisory department of Grant
Thornton Fahn Kanne Control Management. From January 2009 until June 2009, Mr. Silberman worked in the audit department of KPMG, a certified
public accounting firm. Mr. Silberman holds a DCG and a DSCG degrees from the French Ministry of higher study and research and is a certified
public accountant in Israel.
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, a 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.
Mr. Michael Rabinowitz
was appointed Chief Commercial Officer , effective August 1, 2021. Prior to his appointment, from June 1993 until
February 2021, Mr. Rabinowitz served in various marketing, sales, business development, and financial leadership roles at the global biopharmaceutical
company Merck & Co., where he launched and marketed products in over 30 countries across several disease areas, including launching
billion-dollar oral agents in diabetes and managing a global business. Mr. Rabinowitz holds a Masters’ Degree from The Carlson School
of Management, University of Minnesota. He has also participated in executive health care programs at the Harvard Business School.
Mr. Aviad Friedman
became a director in August 2016. Mr. Friedman is an international businessman and since July 2021, he has been acting as
Director General of Israel’s Housing Ministry. From 2007 to 2021, he was 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 15 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 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.
30
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 Quantum
Si Incorporated (formerly 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 Quantum-Si Inc. (Nasdaq: QSI), Aziyo Biologics Inc.
(Nasdaq: AZYO) and Nyxoah SA (Nasdaq: NYXH) as well as a 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 25 years’ experience of playing significant leadership roles in developing businesses. Mr.
Sank serves on the boards of a few national businesses and local non-profit charity organizations in Cape Town, 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.
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 and Leonard Sank are independent as defined under the rules promulgated by Nasdaq.
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 2021, our
Board held 15 meetings and took actions by written consent on 13 occasions. Board members are encouraged to attend our annual
meetings of stockholders.
All of our directors, except
Mr. Gao Xiaoming, whose term as a director expired on August 30, 2021, 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.
31
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:
●
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 Arie Mayer and Kevin Rakin.
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 2021, we believe that during fiscal 2021, 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) Avraham Gabay, our former Chief Financial Officer, failed to timely file a Form 4 reporting his February
3, 2021 acquisition of options to purchase 40,000 shares of our common stock. Mr. Gabay filed a Form 4 reporting this transaction on February
8, 2021, (b) Joshua Hexter, our Chief Operating & Business Officer, failed to timely file a Form 4 reporting his February 3, 2021
acquisition of options to purchase 50,000 shares of our common stock. Mr. Hexter filed a Form 4 reporting this transaction on February
8, 2021, (c) Nadav Kidron, our President, Chief Executive Officer and one of our directors, failed to timely file a Form 4 reporting his
February 3, 2021 acquisition of options to purchase 150,000 shares of our common stock. Mr. Kidron filed a Form 4 reporting this transaction
on February 8, 2021 and (d) Miriam Kidron, our Chief Scientific Officer and one of our directors, failed to timely file a Form 4 reporting
her February 3, 2021 acquisition of options to purchase 100,000 shares of our common stock. Ms. Kidron filed a Form 4 reporting this transaction
on February 8, 2021.
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.
32
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 2021 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.
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 2021, 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.
33
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 2021, our Compensation
Committee increased the base salary of one of our NEOs by 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.
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.
34
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 2021, such
relocation expenses totaled approximately $377,000, and included mainly payments intended to reflect the difference in the cost of living
between Israel and the United States, relocation expenses, accommodation allowances, education allowances, health insurance and related
taxes.
Say-on-Pay Vote
Our stockholders
approved, on an advisory basis, our executive compensation program at our annual meeting of stockholders held on August 3, 2020. We did
not seek or receive any specific feedback from our stockholders concerning our executive compensation program during the past fiscal year.
The Compensation Committee did not specifically rely on the results of the prior vote in making any compensation-related decisions during
fiscal 2021.
REPORT OF THE COMPENSATION COMMITTEE
The Compensation Committee
has reviewed and discussed the foregoing Compensation Discussion and Analysis required by Item 402(b) of Regulation S-K with our management
and, based on such review and discussions, the Compensation Committee recommended to our Board that the Compensation Discussion and Analysis
be included in this Annual Report on Form 10-K and in our proxy statement relating to our next annual meeting of stockholders.
Compensation Committee Members:
Aviad Friedman
Kevin Rakin
Leonard Sank
SUMMARY COMPENSATION TABLE
The following table sets forth the compensation
earned by our NEOs for fiscals 2021, 2020 and 2019.
Name and Principal Position
Year
(1)
Salary
($)
(2)
Bonus
($)
(2)(3)
RSUs Awards
($)
(4)
Option Awards
($)
(4)(5)
All Other
Compensation
($)
(2)(6)
Total
($)
Nadav Kidron
2021
465,982
300,000
1,995,666
876,693
382,240
4,020,581
President and CEO and director (7)
2020
439,076
220,582
-
569,062
539,131
1,767,851
2019
419,460
224,975
-
398,910
507,750
1,551,095
Miriam Kidron
2021
319,868
86,000
1,330,451
584,462
14,193
2,334,974
Chief Scientific Officer and director (8)
2020
305,840
70,000
-
299,506
13,354
688,700
2019
267,386
123,149
-
211,128
14,503
616,166
Avraham Gabay
2021
156,113
60,000
532,174
233,785
43,616
1,025,688
Former Chief Financial Officer (9)
2020
130,554
15,951
-
-
44,912
191,418
2019
32,122
-
-
73,928
9,441
115,491
David Silberman
2021
27,762
-
-
-
4,376
32,138
Chief Financial Officer (10)
Joshua Hexter
2021
206,223
60,000
665,215
292,231
60,720
1,284,389
Chief Operating & Business Officer (11)
2020
190,801
12,169
-
351,128
54,735
608,833
2019
52,848
-
-
-
9,022
61,870
Michael Rabinowitz
2021
30,015
-
986,352
860,416
-
1,876,783
Chief Commercial Officer (12)
35
(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)
For RSU awards, the amounts reflect the grant date fair value, as calculated pursuant to FASB ASC Topic 718. The assumptions used to determine the fair value of the RSU 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 the awards vest and the underlying shares are issued and subsequently sold.
(5)
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.
(6)
Amounts exclude the fair market value of the options that were re-granted on September 11, 2019, 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 resigned from his positions, effective July 4, 2021.
(10)
Mr. Silberman was appointed as Chief Financial Officer, effective July 5, 2021.
(11)
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.
(12)
Mr. Rabinowitz was appointed as Chief Commercial Officer, effective August 1, 2021.
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
2021
4,926
-
-
377,314
382,240
2020
23,438
-
-
515,693
539,131
2019
21,090
-
-
486,660
507,750
Miriam Kidron
2021
14,193
-
-
-
14,193
2020
13,354
-
-
-
13,354
2019
14,503
-
-
-
14,503
Avraham Gabay
2021
14,223
19,222
10,171
-
43,616
2020
16,625
18,606
9,681
-
44,912
2019
2,808
4,405
2,228
-
9,441
David Silberman
2021
-
3,527
849
-
4,376
Joshua Hexter
2021
18,163
28,327
14,230
-
60,720
2020
13,685
26,820
14,230
-
54,735
2019
4,409
1,985
2,628
-
9,022
Michael Rabinowitz
2021
-
-
-
-
-
36
*
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. Starting September 1, 2021, Nadav Kidron receives
a monthly consulting fee of NIS 146,705 and Miriam Kidron receives a monthly consulting fee of NIS 106,400.
We, through Oramed Ltd., have
entered into an employment agreement with David Silberman as of May 23, 2021, pursuant to which Mr. Silberman was appointed as Chief Financial
Officer, Treasurer and Secretary of the Company and Oramed Ltd., effective July 5, 2021. In accordance with the employment agreement,
as amended, Mr. Silberman’s current gross monthly salary is NIS 37,500. In addition, Mr. Silberman is provided with a cellular phone
and a company car allowance pursuant to the terms of his agreement. Starting September 1, 2021, Mr. Silberman’s gross monthly salary
is NIS 43,125.
We, through Oramed Ltd.,
have entered into an employment agreement with Joshua Hexter as of August 18, 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. Starting September 1, 2021, Mr. Hexter’s gross monthly salary is NIS 64,400.
We, through Oramed Inc., have
entered into an employment agreement with Michael Rabinowitz as of July 25, 2021, pursuant to which Mr. Rabinowitz was appointed as Chief
Commercial Officer of the Company, effective August 1, 2021. In accordance with the employment agreement, as amended, Mr. Rabinowitz’s
current gross monthly salary is $27,500. In addition, Mr. Rabinowitz is entitled to a monthly reimbursement of his cell phones expenses
and medical and dental benefits up to a certain amount per year.
We have entered into indemnification
agreements with our directors and officers pursuant to which we agreed to indemnify each director and officer for any liability he or
she may incur by reason of the fact that he or she serves as our director or officer, to the maximum extent permitted by law.
37
Potential Payments upon
Termination or Change-in-Control
We have no plans or arrangements
in respect of remuneration received or that may be received by our named executive officers to compensate such officers in the event of
termination of employment (as a result of resignation, retirement, change-in- control) or a change of responsibilities following a change-in-control.
Pension, Retirement or Similar Benefit Plans
We have no arrangements or
plans under which we provide pension, retirement or similar benefits for directors or executive officers. Our directors and executive
officers may receive stock options, RSUs or restricted shares at the discretion of our Compensation Committee in the future.
GRANTS OF PLAN-BASED AWARDS
The following table shows grants of plan-based
equity awards made to our NEOs during fiscal 2021. Mr. Silberman received no awards during fiscal 2021.
Name
Grant Date
Options Awards:
Number of
Securities
Underlying
Options
(#)
All Other
Stock Awards:
Number of
Securities
Underlying
RSUs
(#)
Grant Date
Fair Value of
Stock Awards
($)
Nadav Kidron (1)
02/03/2021
150,000
-
876,693
Nadav Kidron (2)
02/03/2021
-
300,000
1,995,666
Miriam Kidron (3)
02/03/2021
100,000
-
584,462
Miriam Kidron (4)
02/03/2021
-
200,000
1,330,451
Avraham Gabay (5)
02/03/2021
40,000
-
233,785
Avraham Gabay (6)
02/03/2021
-
80,000
532,174
Joshua Hexter (7)
02/03/2021
50,000
-
292,231
Joshua Hexter (8)
02/03/2021
-
100,000
665,215
Michael Rabinowitz (9)
08/04/2021
100,000
-
860,416
Michael Rabinowitz (10)
08/04/2021
-
100,000
986,352
(1)
These options were granted under our 2019 Plan and shall vest in four equal installments of 37,500 on each of December 31, 2021, December 31, 2022, December 31, 2023 and December 31, 2024.
(2)
These RSUs were granted under our 2019 Plan and shall vest as follows: 100,000 shall vest upon our common stock achieving a price per share of $15 during 20 days out of any 30-day trading period, 100,000 shall vest upon our common stock achieving a price per share of $25 during 20 days out of any 30-day trading period and 100,000 upon achievement of a certain licensing agreement as specified by the Board of Directors.
(3)
These options were granted under our 2019 Plan and shall vest in four equal installments of 25,000 on each of December 31, 2021, December 31, 2022, December 31, 2023 and December 31, 2024.
(4)
These RSUs were granted under our 2019 Plan and shall vest as follows: 66,667 shall vest upon our common stock achieving a price per share of $15 during 20 days out of any 30-day trading period, 66,667 shall vest upon our common stock achieving a price per share of $25 during 20 days out of any 30-day trading period, and 66,666 upon achievement of a certain licensing agreement as specified by the Board of Directors.
(5)
These options were granted under our 2019 Plan and shall vest in four equal installments of 10,000 on each of December 31, 2021, December 31, 2022, December 31, 2023 and December 31, 2024.
(6)
These RSUs were granted under our 2019 Plan and shall vest as follows: 26,666 shall vest upon our common stock achieving a price per share of $15 during 20 days out of any 30-day trading period, 26,667 shall vest upon our common stock achieving a price per share of $25 during 20 days out of any 30-day trading period, and 26,667 upon achievement of a certain licensing agreement as specified by the Board of Directors.
38
(7)
These options were granted under our 2019 Plan and shall vest in four equal installments of 12,500 on each of December 31, 2021, December 31, 2022, December 31, 2023 and December 31, 2024.
(8)
These RSUs were granted under our 2019 Plan and shall vest as follows: 33,333 shall vest upon our common stock achieving a price per share of $15 during 20 days out of any 30-day trading period, 33,333 shall vest upon our common stock achieving a price per share of $25 during 20 days out of any 30-day trading period, and 33,334 upon achievement of a certain licensing agreement as specified by the Board of Directors.
(9)
These options were granted under our 2019 Plan. 12,500 shall vest on December 31, 2021, 25,000 on each of December 31, 2022, December 31, 2023 and December 31, 2024 and 12,500 on August 4, 2025.
(10)
These RSUs were granted under our 2019 Plan and shall vest as follows: 33,333 shall vest upon our common stock achieving a price per share of $15 during 20 days out of any 30-day trading period, 33,333 shall vest upon our common stock achieving a price per share of $25 during 20 days out of any 30-day trading period, and 33,334 upon achievement of a certain licensing agreement as specified by the Board of Directors.
OUTSTANDING EQUITY AWARDS AT FISCAL YEAR-END
The following table sets forth
information concerning stock options and stock awards held by the NEOs as of August 31, 2021.
Option Awards
Stock Awards
Name
Number of
Securities
Underlying
Unexercised
Options (#)
Exercisable
Number of
Securities
Underlying
Unexercised
Options (#)
Unexercisable
Option
Exercise
Price
($)
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
72,750
(4)
24,250
(4)
8.14
1/31/28
98,250
(10)
98,250
(10)(13)
3.16
2/26/29
47,500
(15)
142,500
(15)
4.80
1/8/30
150,000
(17)
10.40
2/3/31
200,000
(7)(8)(21)
3,936,000
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
35,250
(6)
11,750
(6)
8.14
1/31/28
52,000
(11)
52,000
(11)(13)
3.16
2/26/29
25,000
(16)
75,000
(16)
4.80
1/8/30
100,000
(18)
10.40
2/3/31
133,334
(9)(22)
2,624,013
Avraham Gabay
-
(12)
18,500
(12)(13)
3.55
6/17/29
40,000
(19)
10.40
2/3/31
(26)
Joshua Hexter
50,000
(14)
150,000
(14)
3.69
9/11/29
66,667
(23)
1,312,007
50,000
(20)
10.40
2/3/31
Michael Rabinowitz
100,000
(24)
100,000
(24)
15.10
8/4/31
100,000
(25)
1,968,000
39
(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, 2021, 98,000 options were forfeited.
(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; 72,250 of such options
vested on each of January 1, 2019, January 1, 2020 and January 1, 2021 and the remainder of 24,250 shall vest on 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; 35,250 of such options vested in three equal installments of 11,750 on each of January 1, 2019, January 1, 2020 and January 1, 2021 and the remainder of 11,750 shall vest on 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; 98,250 of such option vested on December 31, 2019 and December 31, 2020 and the remainder shall vest in two equal installments of 49,125 on each of 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; 52,000 of such option vested on December 31, 2019 and December 31, 2020 and the remainder shall vest in two equal installments of 26,000 on each of 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.
40
(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 September 11, 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. 47,500 of the options vested on December 31, 2020 and the remainder shall vest in three equal installments of 47,500 on each of 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. 25,000 of the options vested on December 31, 2020 and the remainder shall vest in three equal installments of 25,000 on each of December 31, 2021, December 31, 2022 and December 31, 2023. The options expire on January 8, 2030.
(17)
On February 3, 2021, 150,000 options were granted to Nadav Kidron under the 2019 Plan at an exercise price of $10.40 per share. Such options shall vest in four equal installments of 37,500 on each of December 31, 2021, December 31, 2022, December 31, 2023 and December 31, 2024. The options expire on February 3, 2031.
(18)
On February 3, 2021, 100,000 options were granted to Miriam Kidron under the 2019 Plan at an exercise price of $10.40 per share. Such options shall vest in four equal installments of 25,000 on each of December 31, 2021, December 31, 2022, December 31, 2023 and December 31, 2024. The options expire on February 3, 2031.
(19)
On February 3, 2021, 40,000 options were granted to Avraham Gabay under the 2019 Plan at an exercise price of $10.40 per share. Such options shall vest in four equal installments of 10,000 on each of December 31, 2021, December 31, 2022, December 31, 2023 and December 31, 2024. The options expire on February 3, 2031.
(20)
On February 3, 2021, 50,000 options were granted to Joshua Hexter under the 2019 Plan at an exercise price of $10.40 per share. Such options shall vest in four equal installments of 12,500 on each of December 31, 2021, December 31, 2022, December 31, 2023 and December 31, 2024. The options expire on February 3, 2031.
(21)
On February 3, 2021, 300,000 RSUs, representing a right to receive shares of the Company’s common stock, were granted to Nadav Kidron. 100,000 RSUs vested in one installment on August 31, 2021 and the remainder shall vest per the following: 100,000 shares shall vest upon our common stock achieving a specified price per share, and 100,000 shall vest upon our achievement of certain business objectives. The shares of common stock underlying the RSUs will be issued upon request of the grantee.
(22)
On February 3, 2021, 200,000 RSUs, representing a right to receive shares of the Company’s common stock, were granted to Miriam Kidron. 66,666 RSUs vested in one installment on August 31, 2021 and the remainder shall vest per the following: 66,667 shares shall vest upon our common stock achieving a specified price per share, and 66,667 shall vest upon our achievement of certain business objectives. The shares of common stock underlying the RSUs will be issued upon request of the grantee.
(23)
On February 3, 2021, 100,000 RSUs, representing a right to receive shares of the Company’s common stock, were granted to Joshua Hexter. 33,333 RSUs vested in one installment on August 31, 2021 and the remainder shall vest per the following: 33,333 shares shall vest upon our common stock achieving a specified price per share, and 33,334 shall vest upon our achievement of certain business objectives. The shares of common stock underlying the RSUs will be issued upon request of the grantee.
(24)
On August 4, 2021, 100,000 options were granted to Michael Rabinowitz under the 2019 Plan at an exercise price of $15.10 per share. The options shall vest as follows: 12,500 on December 31, 2021, three equal annual installments of 25,000 on each of December 31, 2022, 2023 and 2024 and 12,500 on August 4, 2025. The options expire on August 4, 2031.
(25)
On August 4, 2021, 100,000 RSUs, representing a right to receive shares of the Company’s common stock, were granted to Michael Rabinowitz. 66,666 shares shall vest upon our common stock achieving a specified price per share, and 33,334 shall vest upon our achievement of certain business objectives.
(26)
Mr. Gabay resigned from his positions, effective July 4, 2021. Following his resignation, 39,250 options and 53,334 RSUs were forfeited.
Compensation Committee Interlocks and Insider Participation
During fiscal 2021, Mr. Aviad Friedman, Mr. Kevin
Rakin and Mr. Leonard Sank served as the members of our Compensation Committee. None of the members of our Compensation Committee is,
or has been, an officer or employee of ours.
41
During the last year, none
of our NEOs served as: (1) a member of the compensation committee (or other committee of the Board performing equivalent functions or,
in the absence of any such committee, the entire board of directors) of another entity, one of whose executive officers served on the
compensation committee; (2) a director of another entity, one of whose executive officers served on the compensation committee; or (3)
a member of the compensation committee (or other committee of the board of directors performing equivalent functions or, in the absence
of any such committee, the entire board of directors) of another entity, one of whose executive officers served as a director on our Board.
DIRECTOR COMPENSATION
The following table provides
information regarding compensation earned by, awarded or paid to each person for serving as a director who is not an executive officer
during fiscal 2021:
Name of Director
Fees
Earned or
Paid in
Cash
($)
Stock
Awards
(2) (3)
($)
Option
Awards
(2)
(3) ($)
All Other
Compensation
($)
Total
($)
Nadav Kidron (1)
-
-
-
-
-
Miriam Kidron (1)
-
-
-
-
-
Aviad Friedman
20,000
-
-
-
20,000
Arie Mayer
20,000
-
-
-
20,000
Kevin Rakin
20,000
217,764
98,048
-
335,812
Leonard Sank
20,000
-
-
-
20,000
Gao Xiaoming (4)
20,000
-
-
-
20,000
(1)
Please refer to the Summary Compensation Table for executive compensation with respect to the named individual.
(2)
As of August 31, 2021, our
non-employee directors then in office held options to purchase shares of our common stock and RSUs as follows:
Name of Director
Aggregate Number
of Shares
Underlying
Stock
Awards
Aggregate Number
of Shares
Underlying
Option
Awards
Aviad Friedman
-
40,857
Arie Mayer
-
20,000
Kevin Rakin
30,000
28,334
Leonard Sank
-
69,867
Gao Xiaoming
-
6,666
(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)
Gao Xiaoming’s term as a director expired on August 30, 2021.
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 2021.
42
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, 2021, options with respect to 2,287,989 shares had been granted, of which 275,673 had been forfeited, 254,697 had been exercised and
1,166,586 have expired. As of August 31, 2021, 525,824 RSUs had been granted, of which 164,636 have vested and the shares of common stock
underlying those RSUs have not been issued and 34,118 have been forfeited.
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, 2021, options with respect to 1,454,646 shares have been granted, of which 52,584 had been forfeited, 31,312 had been
exercised and none of them were expired. As of August 31, 2021, 810,000 RSUs had been granted, of which 236,665 have vested and the shares
of common stock underlying those RSUs have not been issued and 53,334 have been forfeited. 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, 2021:
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
2,883,085
$ 4.57
841,272
Equity compensation plans not approved by security holders
--
--
--
Total
2,883,085
$ 4.57
841,272
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, 2021 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 38,086,020 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, 2021. 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.
43
Name and Address of Beneficial Owner
Number of
Shares
Percentage
of Shares
Beneficially
Owned
Nadav Kidron #+
1,601,821 (1)
4.1 %
Miriam Kidron #+
530,799 (2)
1.4 %
Aviad Friedman #
34,190 (3)
*
Avraham Gabay+
- (4)
*
David Silberman+
-
*
Joshua Hexter+
172,083 (5)
*
Michael Rabinowitz+
66,666 (6)
*
Arie Mayer #
16,333 (7)
*
Kevin Rakin #
68,671 (8)
*
Leonard Sank #
202,089 (9)
*
All current executive officers and directors, as a group (nine persons)
2,692,652 (10)
7.0 %
*
Less than 1%
#
Director
+
NEO
(1)
Includes 545,009 shares of common stock issuable upon the exercise of outstanding stock options and 189,636 shares of Common Stock underlying vested RSUs that are issuable upon request. Mr. Nadav’s beneficial ownership includes the 218,603 shares of common stock held by Xiaopeng Li, a former director of the Company, over which he holds a proxy.
(2)
Includes 389,133 shares of common stock issuable upon the exercise of outstanding stock options and 141,666 shares of Common Stock underlying vested RSUs that are issuable upon request.
(3)
Includes 34,190 shares of common stock issuable upon the exercise of outstanding stock options.
(4)
Mr. Gabay resigned from his positions, effective July 4, 2021.
(5)
Includes 68,750 shares of common stock issuable upon the exercise of outstanding stock options.
(6)
Includes 33,333 shares of common stock issuable upon the exercise of outstanding stock options and 33,333 shares of Common Stock underlying vested RSUs that are issuable upon request.
(7)
Includes 13,333 shares of common stock issuable upon the exercise of outstanding stock options.
(8)
Includes 11,667 shares of common stock issuable upon the exercise of outstanding stock options
(9)
Includes 63,200 shares of common stock issuable upon the exercise of outstanding stock.
(10)
Includes 1,158,615 shares of Common Stock issuable upon the exercise of options beneficially owned by the referenced persons and 364,635 shares of Common Stock underlying vested RSUs that are issuable upon request.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR
INDEPENDENCE.
During fiscals 2021 and 2020,
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.
44
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 would 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 deemed appropriate except for matters related to our activities
in the People’s Republic of China, on which Mr. Kidron would consult with HTIT before taking any action as proxy. On August 19,
2021, the proxy was revoked in accordance with its terms by HTIT.
The Board has determined that
Aviad Friedman, Arie Mayer, Kevin Rakin and Leonard Sank are independent as defined under the rules promulgated by Nasdaq.
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 2021 and 2020:
2021
2020
Audit Fees (1)
$ 90,000
$ 95,000
Audit-Related Fees (2)
47,500
101,000
Tax Fees (3)
1,400
2,000
All Other Fees
-
-
Total Fees
$ 138,900
$ 198,000
(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 February 2020 public offering of common stock for fiscal 2020 and at-the-market offering related fees.
(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.
45
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 loss
F-3
Statements of changes in equity
F-4
Statements of cash flows
F-5
Notes to financial statements
F-6
- F-26
________________
46
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, 2021 and 2020, and the related
consolidated statements of 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, 2021 and 2020, and the results of its
operations and its cash flows for the years then ended in conformity with accounting principles generally accepted in the United States
of America.
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.
Critical Audit Matters
Critical audit matters are
matters arising from the current period audit of the consolidated financial statements that
were communicated or required to be communicated to the audit committee and that (i) relate to accounts or disclosures that are material
to the consolidated financial statements and (ii) involved our especially challenging, subjective,
or complex judgments. We determined there are no critical audit matters.
/s/ Kesselman & Kesselman
Certified Public Accountants (Isr.)
A member firm of PricewaterhouseCoopers International
Limited
Tel Aviv, Israel
November 24, 2021
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,
2021
2020
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$ 77,245
$ 19,296
Short-term deposits (note 2)
11,044
11,060
Marketable securities (note 3)
5,851
9,544
Prepaid expenses and other current assets
1,197
611
Total current assets
95,337
40,511
LONG-TERM ASSETS:
Long-term deposits (note 4)
25,016
2
Marketable securities (note 3)
6,692
3,928
Amounts funded in respect of employee rights upon retirement
24
18
Property and equipment, net
397
99
Operating lease right of use assets
533
75
Total long-term assets
32,662
4,122
Total assets
$ 127,999
$ 44,633
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES:
Accounts payable and accrued expenses (note 5)
$ 3,792
$ 1,699
Deferred revenues
2,703
2,703
Payable to related parties (note 11c)
54
90
Operating lease liabilities
130
44
Total current liabilities
6,679
4,536
LONG-TERM LIABILITIES:
Long-term deferred revenues
4,244
6,947
Employee rights upon retirement
21
18
Provision for uncertain tax position (note 10f)
11
11
Operating lease liabilities
403
31
Other liabilities
124
211
Total long-term liabilities
4,803
7,218
COMMITMENTS
(note 6)
EQUITY
EQUITY ATTRIBUTABLE TO COMPANY’S STOCKHOLDERS’ :
Common stock, $ 0.012 par value ( 60,000,000 authorized shares as of August 31, 2021 and August 31, 2020; 35,293,889 and 23,675,530 shares issued and outstanding as of August 31, 2021 and 2020, respectively)
424
284
Additional paid-in capital
230,201
125,209
Accumulated deficit
( 114,852 )
( 92,614 )
Total stockholders’ equity
115,773
32,879
Non-controlling interests
744
-
Total
equity
116,517
32,879
Total
liabilities and equity
$ 127,999
$ 44,633
The accompanying notes are an integral part
of the financial statements.
F- 2
ORAMED PHARMACEUTICALS
INC.
CONSOLIDATED STATEMENTS OF LOSS
In thousands (except share and per share data)
Year ended
August 31,
2021
2020
REVENUES
$ 2,703
$ 2,710
RESEARCH AND DEVELOPMENT EXPENSES
20,989
10,235
GENERAL AND ADMINISTRATIVE EXPENSES
5,937
4,232
OPERATING LOSS
24,223
11,757
FINANCIAL
INCOME (note 9a)
1,242
690
FINANCIAL
EXPENSES (note 9b)
8
444
NET LOSS
$ 22,989
$ 11,511
NET LOSS ATTRIBUTABLE TO:
COMPANY’S SHAREHOLDERS
22,238
11,511
NON-CONTROLLING INTERESTS
751
-
NET LOSS
22,989
11,511
BASIC AND DILUTED LOSS PER SHARE OF COMMON STOCK
$ 0.78
$ 0.56
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING BASIC AND DILUTED LOSS PER SHARE OF COMMON STOCK
28,469,068
20,532,347
The accompanying notes are an integral part
of the financial statements.
F- 3
ORAMED PHARMACEUTICALS INC.
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
in thousands
Attributable to Company’s Shareholders
Additional
Total
Non-
Common Stock
paid-in
Accumulated
stockholders’
controlling
Total
Shares
$
capital
deficit
equity
interests
Equity
In thousands
BALANCE AS OF SEPTEMBER 1, 2019
17,383
208
100,288
( 81,103 )
19,393
-
19,393
SHARES ISSUED FOR SERVICES
10
*
38
38
38
ISSUANCE OF COMMON STOCK, NET
6,270
75
23,698
23,773
23,773
EXERCISE OF WARRANTS AND OPTIONS
12
1
12
13
13
STOCK-BASED COMPENSATION
-
-
1,173
1,173
1,173
NET LOSS
( 11,511 )
( 11,511 )
( 11,511 )
BALANCE AS OF AUGUST 31, 2020
23,675
284
125,209
( 92,614 )
32,879
32,879
ISSUANCE OF COMMON STOCK, NET
8,467
102
79,881
79,983
79,983
EXERCISE OF WARRANTS AND OPTIONS
3,151
38
21,371
21,409
21,409
STOCK-BASED COMPENSATION
-
-
2,695
2,695
2,695
ASSET ACQUISITION TRANSACTION
1,045
1,045
( 751 )
294
NET LOSS
( 22,238 )
( 22,238 )
1,495
( 20,743 )
BALANCE AS OF AUGUST 31, 2021
35,293
424
230,201
( 114,852 )
115,773
744
116,517
* 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,
2021
2020
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss
$ ( 22,989 )
$ ( 11,511 )
Adjustments required to reconcile net loss to net cash used in operating activities:
Depreciation
77
7
Non-cash expense for acquired In-Process Research & Development (or IPR&D)
1,040
-
Exchange differences and interest on deposits and held to maturity bonds
187
546
Changes in fair value of investments
( 876 )
1,173
Stock-based compensation
2,695
465
Shares issued for services
-
38
Changes in operating assets and liabilities:
Prepaid expenses and other current assets
( 586 )
431
Accounts payable, accrued expenses and related parties
2,060
( 816 )
Deferred revenues
( 2,703 )
( 2,710 )
Liability for employee rights upon retirement
3
( 4 )
Other liabilities
( 89 )
( 59 )
Total net cash used in operating activities
( 21,181 )
( 12,440 )
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of property and equipment
( 375 )
( 82 )
Investment in short-term deposits
( 18,460 )
( 27,204 )
Purchase of mutual funds
-
( 3,750 )
Investment in long-term deposits
( 25,000 )
-
Proceeds from sale of mutual funds
3,765
-
Purchase of held to maturity securities
( 10,362 )
( 8,428 )
Proceeds from redemption of short-term deposits
18,460
40,891
Proceeds from maturity of held to maturity securities
8,209
3,200
Funds in respect of employee rights upon retirement
( 1 )
( 1 )
Total net cash provided by (used in) investing activities
( 23,764 )
4,626
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of common stock, net of issuance costs
79,983
23,773
Proceeds from exercise of warrants and options
21,409
13
Transaction with non-controlling interests
1,500
Total net cash provided by financing activities
102,892
23,786
EFFECT OF EXCHANGE RATE CHANGES ON CASH
2
( 5 )
INCREASE IN CASH AND CASH EQUIVALENTS
57,949
15,967
CASH AND CASH EQUIVALENTS AT BEGINNING OF YEAR
19,296
3,329
CASH AND CASH EQUIVALENTS AT END OF YEAR
$ 77,245
$ 19,296
(A) SUPPLEMENTARY DISCLOSURE ON CASH FLOWS:
Interest received
$ 563
$ 1,313
(B) SUPPLEMENTAL DISCLOSURE OF NON-CASH ACTIVITIES:
Recognition of operating lease right of use assets and liabilities
582
-
(C) ASSET ACQUISITION TRANSACTION (see note 12):
IPR&D
1,040
-
Transaction with non-controlling interests
1,500
-
Additional paid in capital
( 1,045 )
-
Non-controlling interests
( 1,495 )
-
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, 2021, 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”). See note 6b.
On March 18, 2021, the Company entered
into a license agreement (the “Oravax License Agreement”) and into the Stockholders Agreement (as defined below) with Oravax
Medical Inc. (“Oravax”). According to the Stockholders Agreement, Oravax issued 1,890,000 shares of its capital stock to the
Company, representing 63 % of the issued and outstanding share capital of Oravax, on a fully diluted basis, as of the date of issuance.
See note 12.
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”).
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):
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.
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.
August 31, 2021
Level 1
Level 2
Level 3
Fair Value
Assets:
Marketable Securities
D.N.A
701
-
-
701
Entera
571
-
-
571
1,272
-
-
1,272
August 31,
2020
Level 1
Level 2
Level 3
Fair Value
Assets:
Marketable Securities
D.N.A
246
-
-
246
Entera
150
-
-
150
Mutual Funds
3,298
-
-
3,298
3,694
-
-
3,694
As of August 31, 2021, 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.
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):
As of August 31, 2021, 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, 2021, 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.
Other than items related to the asset
acquisition transaction of Oravax (see note 12), there were no Level 3 items measured at fair value for the fiscal 2021.
h. Marketable securities
1)
Equity securities
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.
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.
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 Israeli 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.
Until fiscal 2019, the Israeli subsidiary
has measured its results for tax purposes in nominal terms in NIS. In order to avoid unfavorable tax implications derived from the fluctuations
in the exchange rate, the Israeli subsidiary's results for tax purposes are measured is U.S. dollars starting from fiscal 2020.
Taxes that would apply in the event
of disposal of investments in the Israeli 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.
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):
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 (as
defined below) 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 Standard Codification,
or 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.
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
when the related sale has occurred. To date, the Company has not recognized any royalty-related revenue.
Amounts that were allocated to the License
Agreement as of August 31, 2021 aggregated $ 22,382 , all of which was received through the balance sheet date. Through August 31, 2021,
the Company recognized revenue associated with this agreement in the aggregate amount of $ 15,435 (of which $ 2,703 was recognized in the
twelve-months period ended August 31, 2021), and deferred the remaining amount of $ 6,947 , which is presented as a contract liability on
the condensed consolidated balance sheet.
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):
l. 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.
m. 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 and RSUs
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.
The Company elects to account for forfeitures
as they occur.
n. 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 5,042,299 and 5,025,723 for the years ended August 31, 2021 and 2020, respectively.
o. Asset acquisition
When determining whether a transaction gives rise to an acquisition
of a business or asset group, the Company applies a screening test to determine whether substantially all of the fair value of the gross
assets acquired in the transaction is concentrated in a single identifiable asset or group of similar identifiable assets. If so, then
the assets are not considered a business and the transaction is accounted for as an asset acquisition.
When a transaction is accounted for as an asset acquisition,
an IPR&D asset is only capitalized if it has an alternative future use other than in a particular research and development project.
Otherwise, amounts allocated to IPR&D that have no alternative use are expensed.
The Company has elected an accounting
policy to measure non-controlling interests in an asset acquisition at fair value on the date of acquisition.
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):
p. Leases
The Company leases real estate and cars
for use in its operations, which are classified as operating leases. In addition to rent, the leases may require the Company to pay directly
for fees, insurance, maintenance and other operating expenses.
The Company determines if an arrangement
is a lease at inception. Operating leases are included in operating lease right of use assets and operating lease liabilities in the consolidated
balance sheets. Right of use (“ROU”) assets represent the Company’s right to use an underlying asset for the lease term and
lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities
are recognized at the commencement date based on the present value of lease payments over the lease term. The Company uses its incremental
borrowing rate based on the information available at the commencement date to determine the present value of the lease payments. Lease
expenses are recognized on a straight-line basis over the lease term.
The Company elected the short-term lease
recognition exemption for all leases with a term shorter than 12 months. This means that for those leases, the Company does not recognize
ROU assets or lease liabilities but recognizes lease expenses over the lease term on a straight line basis. The Company also elected the
practical expedient to not separate lease and non-lease components for all of its leases.
Lease terms will include options to extend
or terminate the lease when it is reasonably certain that the Company will either exercise or not exercise the option to renew or terminate
the lease.
The Company’s lease agreements have
remaining lease terms ranging from 1 year to 4 years. Some of these agreements include options to extend the leases for up to an additional
5 years and some include options to terminate the leases immediately. See also note 6h.
q. Recently issued Accounting Pronouncements, not yet adopted
In
June 2016, the Financial Accounting Standards Board 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 is not
expected to have a significant impact on the Company’s consolidated financial statements.
NOTE 2 - SHORT-TERM DEPOSITS:
Composition :
August 31,
2021
2020
Annual interest rate
Amount
Annual
interest rate
Amount
Dollar deposits
0.73 - 0.82 %
$ 11,044
0.85 - 1.60 %
$ 11,060
F- 11
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
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,
2021
2020
Short-term:
D.N.A (see b below)
$ 701
$ 246
Entera (see c below)
571
150
Held to maturity bonds (see d below)
4,579
5,369
Preferred equity
-
481
Mutual funds*
-
3,298
$ 5,851
$ 9,544
Long-term:
Held to maturity bonds (see d below)
$ 6,692
$ 3,928
$ 12,543
$ 13,472
*
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, 2021
and 2020, the Company did not sell any of the D.N.A ordinary shares. As of August 31, 2021, the Company owns approximately 1.7 % of D.N.A’s
outstanding ordinary shares.
The cost of the securities as of August
31, 2021 and 2020 was $ 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. The cost of the securities
as of August 31, 2021 and 2020 was $ 1 .
d.
Held to maturity bonds
The amortized cost and estimated fair
value of held-to-maturity securities at August 31, 2021, are as follows:
August 31, 2021
Amortized
cost
Gross
unrealized
gains (losses)
Estimated
fair value
Average
yield to
maturity
rate
Short-term:
Commercial bonds
$ 4,463
$ ( 98 )
$ 4,365
1.73 %
Accrued interest
116
-
116
Long-term
6,692
610
7,302
1.08 %
$ 11,271
$ 512
$ 11,783
F- 12
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 3 - MARKETABLE
SECURITIES (continued):
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
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.
NOTE 4 - LONG-TERM DEPOSITS:
August 31,
2021
2020
Composition:
Long-term deposits*
$ 25,014
-
Lease car deposits
$ 2
2
$ 25,016
$ 2
* Long term deposits include one deposit of $ 25,000 with an
annual interest rate of 0.93 % and a maturity date of August 10, 2023 .
NOTE 5 - ACCOUNTS PAYABLE AND ACCRUED EXPENSES:
Composition:
August 31,
2021
2020
Accounts payable
$ 2,606
$ 594
Payroll and related accruals
324
54
Institutions
39
19
Accrued liabilities
823
1,032
$ 3,792
$ 1,699
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, 2021, 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- 13
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 6 - COMMITMENTS (continued) :
b. 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.
As of August 31, 2021, 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 $ 6,000 , 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, 2021, and 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. The Company determined that revenues are recognized over time through the expected product submission date in June 2023.
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- 14
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 6 - COMMITMENTS (continued):
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 $ 1,592 was recognized in research and development expenses through August 31, 2021.
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 III 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 $ 7,663 was recognized in research and development expenses
through August 31, 2021.
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 III 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 $ 2,935 was recognized in research and development expenses through August 31, 2021.
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, 2021 was $ 2,207
($ 2,505 including LIBOR). All grants were received before fiscal 2020 and recorded as a reduction of Research and development expenses
at that time. As of August 31, 2021, the liability to the IIA was $ 243 .
The royalty expenses which are related
to the funded project were recognized in cost of revenues in the relevant periods.
g.
Grants from the European Commission (“EC”)
During fiscal 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 of August 31, 2021, all amounts were
recognized in the Company’s profit and loss statement.
F- 15
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 6 - COMMITMENTS (continued):
h.
Leases
On August 2, 2020, the Subsidiary entered
into a lease agreement for its facilities in Israel. The lease agreement is for a period of 60 months commencing September 1, 2020. The
Subsidiary has the option to extend the period for another 60 months. The annual lease payment, including management fees, as of August
31, 2021 is approximately NIS 435,000 ($136). As security for its obligation under this lease agreement, the Company provided a bank guarantee
in an amount equal to three monthly lease payments.
The total expenses related to leases were
$ 124 and $ 56 as of August 31, 2021 and 2020 respectively.
The right-of-use asset and lease liability
are initially measured at the present value of the lease payments, discounted using the interest rate implicit in the lease or, if that
rate cannot be readily determined, the Company’s incremental borrowing rate based on the information available at the date of adoption
in determining the present value of the lease payments. The Company’s incremental borrowing rate is estimated to approximate the
interest rate on similar terms and payments and in economic environments where the leased asset is located.
The Company has various operating leases
for office space and vehicles that expire through 2025 . Below is a summary of the Company’s operating right-of-use assets and operating
lease liabilities as of August 31, 2021 and 2020:
August 31,
2021
August 31,
2020
Operating right-of-use assets
$ 533
$ 75
Operating lease liabilities, current
130
44
Operating lease liabilities long-term
403
31
Total operating lease liabilities
$ 533
$ 75
Weighted Average of Remaining Lease Term
Operating leases
3.88
1.74
Weighted Average Discount Rate
Operating leases
3.00 %
3.00 %
Minimum lease payments for the Company’s right-of-use assets
over the remaining lease periods as of August 31, 2021 are as follows:
August 31,
2021
2022
$ 156
2023
138
2024
136
2025
136
Total undiscounted lease payments
565
Less: Interest*
( 32 )
Present value of lease liabilities
$ 533
* Future lease payments were discounted by 3 % interest rate.
F- 16
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, 2021 and 2020:
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 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 could, 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 were to 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 paid 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, 2021, 3,212,621 shares were issued under the Sales Agreement for aggregate net proceeds of $ 14,397 .
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. On December 1, 2020, the Company entered into a new equity distribution
agreement (the “New Sales Agreement”), pursuant to which the Company could, 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 $ 40,000 , 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 dated February 10, 2020 as supplemented by a prospectus supplement dated December 1, 2020. The Company paid 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 New Sales
Agreement. As of August 31, 2021, 4,061,956 shares were issued under the New Sales Agreement for aggregate net proceeds of $ 38,799 .
F- 17
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 7 - STOCKHOLDERS’ EQUITY (continued):
e. On June 16, 2021, the Company entered into an equity distribution agreement (the “Equity Distribution Agreement”) with Canaccord Genuity LLC, as agent (“Canaccord Genuity”), pursuant to which the Company could issue and sell shares of its common stock having an aggregate offering price of up to $ 28,000 from time to time through Canaccord Genuity. The Equity Distribution Agreement replaced the New Sales Agreement, once it had been exhausted. Any shares sold will be sold pursuant to the Company’s effective shelf registration statement on Form S-3 including a prospectus dated February 10, 2020 and prospectus supplement dated June 16, 2021. The Company paid 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 Equity Distribution Agreement. As of August 31, 2021, 1,823,287 shares were issued under the Equity Distribution Agreement for aggregate net proceeds of $ 27,119 .
f. On July 15, 2021, the Company entered into a new equity distribution
agreement (the “New Equity Distribution Agreement”) with Canaccord Genuity, pursuant to which the Company may issue and sell
shares of its common stock having an aggregate offering price of up to $ 100,000 from time to time through Canaccord Genuity. The New Equity
Distribution Agreement replaced the Equity Distribution Agreement, once it had been exhausted. Any shares sold will be sold pursuant to
the Company’s effective shelf registration statement on Form S-3 including a prospectus dated July 15, 2021. The Company paid 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 New Equity
Distribution Agreement. As of August 31, 2021 and through November 24, 2021, 208,451 and 273,997 shares were respectively issued under
the New Equity Distribution Agreement for aggregate net proceeds of $ 3,884 .
g. As of August 31, 2021, the Company had outstanding warrants exercisable commencing January 6, 2019 for 232,175 shares of common stock at exercise prices ranging from $ 4.13 to $ 7.8125 per share and expiring from January 6, 2022 to April 15, 2029.
The following table presents the warrant
activity for the years ended August 31, 2021 and 2020:
Year ended
August 31,
2021
2020
Warrants
Weighted-
Average
Exercise
Price
Warrants
Weighted-
Average
Exercise
Price
Warrants outstanding at beginning of year
3,407,820
$ 6.98
3,007,680
$ 7.27
Issued
-
$ -
400,140
$ 4.77
Exercised
3,175,645
$ 7.07
-
$ -
Expired
-
$ -
-
$ -
Warrants outstanding at end of year
232,175
$ 5.57
3,407,820
$ 6.98
Warrants exercisable at end of year
232,175
$ 5.57
3,407,820
$ 6.98
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 or RSU 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 and RSUs is 10 years.
The following are the significant stock
options and RSUs transactions with employees, board members and non-employees made during the years ended August 31, 2021 and 2020:
a. On September 11, 2019, the Company granted options to its Chief Operating
and Business 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, 2021, 50,000 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.
F- 18
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 8 - STOCK-BASED COMPENSATION (continued):
b. On September 11, 2019, the Company granted options to its Chief Operating
and Business 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 four installments
upon achievement of certain performance conditions. As of August 31, 2021, 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.
c. 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. As of August 31, 2021, 33,330 of such options are vested. 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 .
d.
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 Company’s Chief Executive Officer, or
CEO, and 100,000 to the Company’s Chief Scientific Officer, or CSO. The options shall vest in four equal annual installments, on
each of December 31, 2020, 2021, 2022 and 2023. As of August 31, 2021, 72,500 of such options are vested. 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.
e.
On February 3, 2021, the Company granted options
to purchase an aggregate of 340,000 shares of common stock of the Company at an exercise price of $ 10.40 per share (equivalent to the
closing price of the Company’s common stock on the date of grant) as follows: 150,000 to the CEO, 100,000 to the CSO, 40,000 to
the Company’s former Chief Financial Officer and 50,000 to the Company’s Chief Operating & Business Officer. The options
shall vest in four equal annual installments, on each of December 31, 2021, 2022, 2023 and 2024. These options expire on February 3, 2031.
The fair value of all these options on the date of grant was $ 1,987 , using the Black Scholes option-pricing model and was based on the
following assumptions: stock price of $ 10.40 ; dividend yield of 0 % for all years; expected volatility of 61.07 %; risk-free interest rates
of 0.64 %; and expected term of 6.21 years.
On February 3, 2021, the Company granted a total of 680,000 RSUs as
follows: 300,000 to the CEO, 200,000 to the CSO, 80,000 to the Company’s former Chief Financial Officer and 100,000 to the Company’s
Chief Operating and Business Officer. These RSUs were granted under the Company’s 2019 Plan and shall vest as follows: 226,666 shall
vest upon the Company’s common stock achieving a price per share of $ 15 during 20 days out of any 30-day trading period, 226,667
shall vest upon the Company’s common stock achieving a price per share of $ 25 during 20 days out of any 30-day trading period, and
226,667 upon achievement of a certain licensing agreement as specified by the Board of Directors. The total fair value of these RSUs on
the date of the grant was $ 4,511 , using the Monte-Carlo model.
f.
On February 17, 2021, the Company granted options
to purchase an aggregate of 15,000 shares of common stock of the Company at an exercise price of $ 11.33 per share (equivalent to the closing
price of the Company’s common stock on the date of grant) to the chairman of the Board of Directors. The options shall vest in three
equal annual installments, on each of December 31, 2021, 2022 and 2023. These options expire on February 17, 2031. The fair value of all
these options on the date of grant was $ 98 , using the Black Scholes option-pricing model and was based on the following assumptions: stock
price of $ 11.33 ; dividend yield of 0 % for all years; expected volatility of 64.39 %; risk-free interest rates of 0.76 %; and expected term
of 5.94 years.
On February 17, 2021, the Company granted a total of 30,000 RSUs to
the chairman of the Board of Directors. These RSUs were granted under the Company’s 2019 Plan and shall vest as follows: 10,000
shall vest upon the Company’s common stock achieving a price per share of $ 15 during 20 days out of any 30-day trading period, 10,000
shall vest upon the Company’s common stock achieving a price per share of $ 25 during 20 days out of any 30-day trading period, and
10,000 upon achievement of a certain licensing agreement as specified by the Board of Directors. The total fair value of these RSUs on
the date of the grant was $ 217 , using the Monte-Carlo model.
F- 19
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 August 4, 2021, the Company granted options to purchase an aggregate of 100,000 shares of common stock of the Company at an exercise price of $ 15.10 per share (equivalent to the closing price of the Company’s common stock on the date of grant) to the Chief Commercial Officer. The options shall vest as follows: 12,500 on December 31, 2021, three equal annual installments of 25,000 on each of December 31, 2022, 2023 and 2024 and 12,500 on August 4, 2025. These options expire on August 4, 2031. The fair value of all these options on the date of grant was $ 860 , using the Black Scholes option-pricing model and was based on the following assumptions: stock price of $ 15.10 ; dividend yield of 0 % for all years; expected volatility of 61.98 %; risk-free interest rates of 0.82 %; and expected term of 6.17 years.
On August 4, 2021, the Company granted a total of 100,000 RSUs to the Chief Commercial Officer. These RSUs were granted under the Company’s 2019 Plan and shall vest as follows: 33,333 shall vest upon the Company’s common stock achieving a price per share of $ 15 during 20 days out of any 30-day trading period, 33,333 shall vest upon the Company’s common stock achieving a price per share of $ 25 during 20 days out of any 30-day trading period, and 33,334 upon achievement of a certain licensing agreement as specified by the Board of Directors. The total fair value of these RSUs on the date of the grant was $ 985 , using the Monte-Carlo model.
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,
2021
2020
Expected option life (years)
5.94 - 6.21
5.74 - 6.24
Expected stock price volatility (%)
61.07 - 64.39
57.77 - 68.14
Risk free interest rate (%)
0.64 - 0.82
1.67 - 1.89
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, 2021 and 2020, and changes during the years ended on those dates, is presented below:
Year ended
August 31,
2021
2020
Number
of
options
Weighted
average
exercise
price
Number
of
options
Weighted
average
exercise
price
$
$
Options outstanding at beginning of year
1,597,149
5.47
1,264,645
6.11
Changes during the year:
Granted
455,000
11.46
943,646
3.98
Forfeited
( 52,584
)
7.78
( 392,646
)
3.79
Expired
-
-
( 206,243
)
6.02
Exercised
( 93,782
)
6.42
( 12,253
1.00
Options outstanding at end of year
1,905,783
6.79
1,597,149
5.47
Options exercisable at end of year
859,447
687,024
Weighted average fair value of options granted during the year
$
6.47
$
2.79
Expenses recognized in respect of stock
options granted to employees and directors, for the years ended August 31, 2021 and 2020 were $ 1,409 and $ 1,086 , respectively.
The total intrinsic value of employees’
options exercised during the year ended August 31, 2021 was $ 1,287 and $ 27 during the year ended August 31, 2020.
F- 20
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, 2021:
Exercise
prices
Number outstanding
Weighted
Average
Remaining
Contractual
Life
Weighted
average
exercise
price
$
Years
$
1.00 to 6.00
1,064,084
7.01
3.98
6.23 to 9.12
306,781
6.11
7.94
10.40 to 15.10
534,918
8.12
11.73
1,905,783
7.18
6.79
859,447 options granted to employees and
directors that were outstanding as of August 31, 2021 were also exercisable as of August 31, 2021, compared to 687,024 as of August 31,
2020.
As of August 31, 2021, there were $ 2,598
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 1.3 years.
A summary of the status of the stock options
granted to non-employees outstanding as of August 31, 2021 and 2020, and changes during the years ended on those dates, is presented below:
Year ended
August 31,
2021
2020
Number
of
options
Weighted
average
exercise
price
Number
of
options
Weighted
average
exercise
price
$
$
Options outstanding at beginning of year
103,152
6.64
47,152
9.51
Changes during the year:
Granted
-
-
56,000
4.21
Exercised
( 10,000 )
7.36
-
-
Forfeited
-
-
-
-
Expired
( 37,152 )
6.00
-
-
Options outstanding at end of year
56,000
4.22
103,152
6.64
Options exercisable at end of year
46,000
4.03
65,152
5.58
Weighted average fair value of options granted during the year
$ -
$ 2.47
The Company recorded stock-based compensation
of $ 22 and $ 87 during the years ended August 31, 2021 and 2020, respectively, related to non-employees’ awards.
10,000 options were exercised by non-employees
during the year ended August 31, 2021 for a total intrinsic value of $ 100 while no options were exercised by non-employees during the
year ended August 31, 2020.
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):
The following table presents summary information
concerning the options granted to non-employees outstanding as of August 31, 2021:
Range of
exercise
prices
Number outstanding
Weighted
Average
Remaining
Contractual
Life
Weighted
Average
Exercise
Price
$
Years
$
3.74-5.08
56,000
8.30
4.22
46,000 options granted to non-employees
that were outstanding as of August 31, 2021, were also exercisable as of August 31, 2021.
As of August 31, 2021, there were $ 2 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 0.17 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, 2021 and 2020:
Year ended
August 31,
2021
2020
Number of RSUs
Vested and unissued at the beginning of period
164,636
164,636
Granted
810,000
-
Forfeited
( 53,334 )
-
Outstanding at the end of the period
921,302
164,636
Vested
236,665
-
Vested and unissued
401,301
164,636
The Company recorded compensation expenses
related to RSUs of $ 1,265 for the year ended August 31, 2021. During the year ended August 31, 2020, the Company did not record expense
or income related to RSUs.
As of August 31, 2021, there were unrecognized compensation costs of $ 4,201 related to RSUs. The unrecognized compensation costs are expected
to be recognized over a weighted average period of 1.06 years.
F- 22
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,
2021
2020
Income from interest on deposits
$ 130
$ 552
Income from interest on corporate bonds
217
138
Gain from securities, net
6
-
Revaluation of securities, net
889
-
$ 1,242
$ 690
b.
Financial expenses
Year ended
August 31,
2021
2020
Exchange rate differences, net
$
2
$
6
Bank and broker commissions
5
6
Loss from securities, net
-
432
Other
1
-
$
8
$
444
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 Israeli subsidiary.
a.
Corporate taxation in the U.S.
The applicable corporate tax rate for
the Company is 21 %.
As of August 31, 2021, the Company has
an accumulated tax loss carryforward of approximately $ 19,159 (as of August 31, 2020, $ 15,880 ). 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 rate applicable to 2021 and 2020 is 23 %.
As of August 31, 2021, the Subsidiary
has an accumulated tax loss carryforward of approximately $ 73,762 (as of August 31, 2020, approximately $ 57,900 ). Under the Israeli tax
laws, carryforward tax losses have no expiration date.
F- 23
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,
2021
2020
In respect of:
Net operating loss carryforward
$ 21,196
$ 16,652
Research and development expenses
3,877
2,740
Less - valuation allowance
( 25,073 )
( 19,392 )
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.
d.
Loss before taxes on income and income taxes included in the income statements of operations:
Year ended
August 31,
2021
2020
Loss before taxes on income:
U.S.
$ 5,307
$ 2,868
Outside U.S.
17,682
8,643
$ 22,989
$ 11,511
Taxes on income (tax benefit):
Current:
U.S.
-
-
Outside U.S.
-
-
$ -
$ -
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,
2021
2020
Loss before income taxes as reported in the consolidated statement of comprehensive loss
$ ( 22,989 )
$ ( 11,511 )
Statutory tax benefit
( 4,828 )
( 2,417 )
Increase in income taxes resulting from:
Change in the balance of the valuation allowance for deferred tax
4,872
3,154
Disallowable deductions
310
135
Influence of different tax rate applicable to the Subsidiary and changes in tax rates from previous years
( 354 )
( 872 )
Withholding tax, see note 10d above
-
-
Uncertain tax position
-
-
Taxes on income for the reported year
$ -
$ -
F- 24
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 10 - TAXES ON INCOME (continued):
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,
2021
2020
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.
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, 2021
$ 19,392
$ 5,681
$ 25,073
Year ended August 31, 2020
16,238
3,154
19,392
NOTE 11 - RELATED PARTIES - TRANSACTIONS:
a. During each of the fiscal years of 2021 and 2020, the Company paid to directors $ 100 and $ 95 , 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 ($40) and NIS 92,522 ($29), respectively.
Starting September 1, 2021, the CEO receives a monthly consulting fee of NIS 146,705 ($46) and the CSO receives a monthly consulting fee of NIS 106,400 ($33)
F- 25
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE
11 - RELATED PARTIES - TRANSACTIONS (continued):
In addition to the Consulting Agreements,
based on a relocation cost analysis, 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 2021 and 2020, such relocation expenses totaled $ 377 and $ 516 , respectively.
c.
Balances with related parties:
August 31,
2021
2020
Accounts payable and accrued expenses - KNRY
$ 54
$ 90
d.
Expenses to related parties:
Year ended
August 31,
2021
2020
KNRY
$ 872
$ 766
Nadav Kidron (CEO)
$ 687
801
NOTE 12 - ASSET ACQUISITION TRANSACTION
On March 18, 2021, the Company entered into the
Oravax License Agreement and into the Stockholders Agreement (as defined below) with Oravax. On that date, Oravax’s assets were
(1) in process research and development of COVID-19 vaccine technology; and (2) $1,500 received in cash. According to the Stockholders
Agreement, Oravax issued 1,890,000 shares of its capital stock to the Company, representing 63% of the issued and outstanding share capital
of Oravax, on a fully diluted basis, as of the date of issuance. Consequently, the Company is consolidating Oravax in its consolidated
financial statements as from the inception of Oravax. In addition, under the terms of the Oravax License Agreement, the Company has licensed
out to Oravax certain patent rights, know-how and information related to the Company’s oral drug delivery technology with respect
to the combination with the COVID-19 vaccine technology (the “Licensed IP”).
In consideration for the grant of the License,
the Oravax License Agreement provides that the Company will receive (i) royalties equal to 7.5 % on net sales, as defined in the Oravax
License Agreement, of each product commercialized by Oravax, its affiliates and permitted sublicensees related to the License during the
term specified in the Oravax License Agreement, (ii) sublicensing fees equal to 15 % of any non-sales-based consideration received by Oravax
from a permitted sublicensee and (iii) other payments ranging between $ 25,000 to $ 100,000 , based on certain sales milestones being achieved
by Oravax. The parties further agreed to establish a development and steering committee, which will consist of three members, of which
two members will be appointed by the Company, that will oversee the ongoing research, development, clinical and regulatory activity with
respect to the Oravax Product. Akers Biosciences Inc. (“Akers”) contributed Oravax $ 1,500 in cash and a license agreement
to the Oravax Product which includes a maximum of 2.5 % royalties of all net sales.
Concurrently with the execution and delivery of
the Oravax License Agreement, the Company entered into a Stockholders Agreement (the “Stockholders Agreement”), with Akers,
Premas Biotech Pvt. Ltd. (“Premas”), Cutter Mill Capital LLC (“Cutter Mill”), and Run Ridge LLC (“Run Ridge”),
entities controlled by Michael Vasinikovich and Craig Schwabe, former members of Cystron, and collectively with Akers, Premas, Cutter
Mill and Run Ridge, the Stockholders Parties. Pursuant to the Stockholders Agreement, among other things, the Company will have the right
to appoint two out of the three members to the board of directors of Oravax (the “Oravax Board”), one of which is the Company’s
Chief Executive Officer who will serve as the chairman of the Oravax Board, conditioned upon the Company maintaining certain ownership
thresholds. Akers will have the right, until the third anniversary of the Stockholders Agreement effective date, to appoint one member
to the Oravax Board. Oravax’s common stock held by the Stockholders Parties will be subject to certain transfer restrictions. In
addition, the Stockholders Parties will have certain rights of participation in future financings as well as rights of first refusal and
co-sale related to future potential transactions.
F- 26
ORAMED PHARMACEUTICALS INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (continued)
In thousands (except share and per share data)
NOTE 12 - ASSET ACQUISITION TRANSACTION
(continued):
According to ASC 805, the transaction was accounted
for as an asset acquisition. No gain or loss was recognized on the transfer of the cash or the Licensed IP to Oravax while the Company
retained control of those assets. The Company has recognized an increase in non-controlling interests of $ 1,495 based on the carrying
amount of the contributed assets and, according to the Company’s accounting policy, the fair value of Oravax excluding the contributed
assets. Any difference between the fair value of consideration paid and the increase in the non-controlling interests’ carrying
amount was recognized in equity. As a result of the acquisition, the Company recognized IPR&D expense in the amount of $ 1,040 .
NOTE 13 - SUBSEQUENT EVENTS
a. On September 1, 2021, the Company granted options
to its Chief Financial Officer to purchase an aggregate of 50,000 shares of common stock of the Company at an exercise price of $ 20.19
per share. The options shall vest in four equal installments of 12,500 options on each of June 27, 2022, June 27, 2023, June 27, 2024
and June 27, 2025. In addition, The Company granted 50,000 RSUs that shall vest as follows:
33,333 if the closing price per share of the Company’s common
stock will be at least $25 for at least 20 days out of any 30-trading day period; and
1. If the first condition is met anytime before June 27, 2022, then the RSUs will vest in three equal installments (on June 27, 2022,
June 27, 2023 and June 27, 2024).
2. If the first condition is met anytime between June 27, 2022 and June 27, 2023, then 1/3 of the RSUs will vest immediately, and the
remainder will vest in two equal installments (on June 27, 2023 and June 27, 2024).
3. If the first condition is met anytime between June 27, 2023 and June 27, 2024, then 2/3 of the RSUs will vest immediately, and the
remaining 1/3 will vest on June 27, 2024).
4. If the first condition is met anytime after June 27, 2024, then the RSUs will vest immediately.
16,667 upon achievement of a certain licensing agreement as specified by the Board of Directors; and
1.
If the first condition is met anytime before June 27, 2022, then the RSUs will vest in three equal installments (on June 27, 2022, June 27, 2023 and June 27, 2024).
2.
If the first condition is met anytime between June 27, 2022 and June 27, 2023, then 1/3 of the RSUs will vest immediately, and the remainder will vest in two equal installments (on June 27, 2023 and June 27, 2024).
3.
If the first condition is met anytime between June 27, 2023 and June 27, 2024, then 2/3 of the RSUs will vest immediately, and the remaining 1/3 will vest on June 27, 2024).
4. If the first condition is met anytime after June 27, 2024, then the RSUs will vest immediately.
These options and RSUs expire on September 1, 2031 .
The total value of the options and RSUs is $ 1,572 .
b. On September 1, 2021, the Company entered into a controlled equity offering agreement, or the Cantor Equity Distribution Agreement,
with Cantor Fitzgerald & Co., as agent (“Cantor Fitzgerald”), pursuant to which the Company may issue and sell shares
of its common stock having an aggregate offering price of up to $ 100,000 from time to time through Cantor Fitzgerald. As of November 24,
2021, 565,120 shares issued under the Cantor Equity Distribution Agreement for aggregate net proceeds of $ 12,298 .
c. On November 3, 2021, the Company entered into a securities purchase
agreement with several institutional and accredited investors, or the Purchasers, pursuant to which the Company agreed to sell, in a registered
direct offering, or the Offering, an aggregate of 2,000,000 shares of the Company’s common stock, or the Shares, to the Purchasers
for an offering price of $ 25 per Share. The closing of the sale of the Shares occurred on November 5, 2021. The net proceeds to the Company
from the Offering, after deducting the placement agent’s fees and expenses and the Company’s estimated Offering expenses,
were approximately $ 46,375 .
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.
F- 27
(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 (incorporated by reference from our annual report on Form 10-K filed November 24, 2020)
3.3
Second Amended and Restated By-laws (incorporated by reference from our current report on Form 8-K filed July 15, 2021).
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 (incorporated by reference from our annual report on Form 10-K filed November 24, 2020).
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).
47
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+*
Amendment, dated September 19, 2021, to Consulting Agreements by and between Oramed Ltd. and KNRY, Ltd., entered into as of July 1, 2008, for the services of Nadav Kidron.
10.8+
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).
10.9+
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).
10.10+
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).
10.11+
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).
10.12+
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).
10.13+
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).
10.14+*
Amendment, dated September 19, 2021, to Consulting Agreements by and between Oramed Ltd. and KNRY, Ltd., entered into as of July 1, 2008, for the services of Miriam Kidron .
10.15+
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).
10.16+
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).
48
10.17+
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).
10.18+
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).
10.19+
Oramed Pharmaceuticals Inc. 2019 Stock Incentive Plan (incorporated by reference from our definitive proxy statement on Schedule 14A filed August 6, 2019).
10.20+
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).
10.21+
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).
10.22+
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).
10.23+
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).
10.24+*
Employment Agreement, dated July 25, 2021, by and between the Company and Michael Rabinowitz.
10.25+
Employment Agreement, dated May 23, 2021, by and between Oramed Ltd. and David Silberman (incorporated by reference from our quarterly report on Form 10-Q filed July 14, 2021).
10.26+*
First Amendment, dated September 19, 2021, to Employment Agreement, by and between Oramed Ltd. and David Silberman.
10.27+
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).
10.28+
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).
10.29
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).
10.30
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).
49
10.31+*
Representative Form of Indemnification Agreements between Oramed Pharmaceuticals Inc. and each of our directors and officers.
10.32+
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).
10.33+*
First Amendment, dated September 19, 2021, to Employment Agreement, by and between Oramed Ltd. and Joshua Hexter.
10.34
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).
10.35
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).
10.36
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).
10.37
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).
10.38
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).
10.39
Equity Distribution Agreement, dated July 15, 2021, by and between the Company and Canaccord Genuity LLC (incorporated by reference from our current report on Form 8-K filed July 15, 2021).
10.40
Equity Distribution Agreement, dated September 1, 2021, by and between the Company and Cantor Fitzgerald & Co. (incorporated by reference from our current report on Form 8-K filed September 1, 2021).
10.41
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).
50
10.42
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).
10.43
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).
10.44
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).
10.45
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).
10.46
License Agreement, dated as of March 18, 2021, between the Company, Oramed Ltd. and Oravax Medical Inc. (incorporated by reference from our Form 8-K filed March 19, 2021).
10.47
Stockholders Agreement, dated as of March 18, 2021, between Oramed Pharmaceuticals Inc., Akers Biosciences Inc., Premas Biotech PVT Ltd., Cutter Mill Capital LLC, and Run Ridge LLC. (incorporated by reference from our Form 8-K filed March 19, 2021).
21.1*
Subsidiaries.
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.
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, 2021, formatted in XBRL (eXtensible
Business Reporting Language): (i) Consolidated Balance Sheets, (ii) Consolidated Statements of 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.
104.1*
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).
* Filed
herewith.
** Furnished
herewith.
+ Management
contract or compensation plan.
ITEM 16. FORM 10-K SUMMARY.
None.
51
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, 2021
52
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, 2021
Nadav Kidron,
President and Chief Executive Officer and Director
(principal executive officer)
/s/ DAVID SILBERMAN
November 24, 2021
David Silberman,
Chief Financial Officer
(principal financial and accounting officer)
/s/ AVIAD FRIEDMAN
November 24, 2021
Aviad Friedman,
Director
/s/ MIRIAM KIDRON
November 24, 2021
Miriam Kidron,
Director
/s/ ARIE MAYER
November 24, 2021
Arie Mayer,
Director
/s/ KEVIN RAKIN
November 24, 2021
Kevin Rakin,
Director
/s/ LEONARD SANK
November 24, 2021
Leonard Sank,
Director
53