March 25, 2020
Joseph Moscato
President and Chief Executive Officer
GENEREX BIOTECHNOLOGY CORP
10102 USA Today Way
Miramar, FL 33025
Re: GENEREX BIOTECHNOLOGY CORP
Form 10-K for the Fiscal Year Ended July 31, 2019
Filed November 12, 2019
File No. 000-25169
Dear Mr. Moscato:
We have limited our review of your filing to the financial statements
and related
disclosures and have the following comments. In some of our comments, we may
ask you to
provide us with information so we may better understand your disclosure.
Please respond to these comments within ten business days by providing
the requested
information or advise us as soon as possible when you will respond. If you do
not believe our
comments apply to your facts and circumstances, please tell us why in your
response.
After reviewing your response to these comments, we may have additional
comments.
Form 10-K for the Fiscal Year Ended July 31, 2019
Management's Discussion and Analysis
Financial Condition, Liquidity and Resources
Sources of Liquidity, page 70
1. You state that your July 31, 2019 cash position was not sufficient for 12
months of
operations and that anticipated revenues associated with the Veneto
acquisition are
expected to dramatically alter the cash flow landscape. Given the
litigation with Veneto
and the uncertainty relating to the assets acquired, tell us the basis
for the company's
assertions.
Management's Discussion and Analysis
Results of Operations, page 70
2. For each significant key research and development project, provide the
following to be
included in future filings:
Joseph Moscato
FirstName LastNameJoseph Moscato
GENEREX BIOTECHNOLOGY CORP
Comapany2020
March 25, NameGENEREX BIOTECHNOLOGY CORP
Page 2
March 25, 2020 Page 2
FirstName LastName
the costs incurred during each period presented, reconciled to
your research and
development on your Statements of Operations
the nature of efforts and steps necessary to complete the
project,
reasons for significant increases or decreases in research and
development from
period to period,
expected future increases or decreases in research and
development,
the risks and uncertainties associated with completing
development,
the extent and nature of additional resources that need to be
obtained if current
liquidity is not expected to be sufficient to complete the
project, and
your estimate of the date of completion of any future milestone
such as completion of
a development phase, date of filing an NDA with a regulatory
agency, or approval
from a regulatory agency.
Consolidated Statements of Operations and Comprehensive (Loss) Income, page 82
3. The changes in fair value of contingent purchase consideration were
$18,587,782 and
$39,027,901 and $0 in the years ended July 31, 2019 and 2018 and three
months ended
October 31, 2019, respectively. Please tell us the amount of
contingent consideration at
each balance sheet date and the components thereof. Also tell us your
consideration of
separately presenting the contingent consideration on the face of the
balance sheet.
Clarify to us why there was no change in the fair value in the three
months ended October
31, 2019 either to the contingent consideration outstanding at July
31, 2019 or the
additional contingent consideration recorded in connection with the
MediSource and
Pantheon acquisitions as disclosed on page 22 of your October 31, 2019
10-Q.
Consolidated Statements of Changes in Stockholders' Equity, page 83
4. You state on pages 95 and 109 that in May 2019 you issued 4 million
shares of common
stock in exchange for 592,682 shares of Series A preferred stock of
Olaregen. You also
state on page 104 that in connection with the Amendment Agreement for
the Veneto
acquisition you delivered 8,400,000 shares on May 23, 2019. Please
tell us where the
issuance of shares is presented in the Statements of Changes in
Stockholders' Equity.
You issued 1,953,257 common stock for the issuance of common stock for
conversion of
debt and recorded $18,404,731 of additional paid-in-capital. Please
provide us an analysis
of the transactions, including how the amount recorded to additional
paid-in capital was
determined in light of your stock price at the time of the
transactions. Also, please
reconcile the transactions to the disclosure presented on page 83 and
elsewhere in the
filing, as applicable.
Revenue Recognition, page 86
5. You disclose several different types of revenue streams such as
product sales, pharmacy
prescriptions, laboratory services, and management services. Please
revise to provide the
following or tell us why additional disclosure is not required:
Joseph Moscato
FirstName LastNameJoseph Moscato
GENEREX BIOTECHNOLOGY CORP
Comapany2020
March 25, NameGENEREX BIOTECHNOLOGY CORP
Page 3
March 25, 2020 Page 3
FirstName LastName
disaggregated revenue recognized pursuant to ASC 606-10-50-5 and
ASC 606-10-55-
89 through 55-91, including disclosure relating to geographical
regions if applicable,
significant judgments and changes in judgments pursuant to ASC
606-10-50-17,
including how variable consideration was determined for each
significant revenue
stream,
contract balances pursuant to ASC 606-10-50-6 through
606-10-50-11, and
additional disclosure in Management's Discussion and Analysis
quantifying each
significant factor that resulted in significant changes in
revenue and the extent to
which the change relates to price vs. volume. Refer to item
303(a)(3) of Regulation
S-K.
Notes to the Consolidated Financial Statements
Note 2 - Summary of Significant Accounting Policies
Research and Development Costs, page 88
6. You state on page 11 that you have entered into agreements with Merck
and NSABP to
conduct a Phase II trial to evaluate the safety and efficacy of AE37
in combination with
KEYTRUDA. You also state that you are advancing AE37 for the treatment
of prostate
cancer through a licensing and research agreement with Shenzhen. For
these agreements
and any other agreements entered into subsequent to July 31, 2019,
tell us the date of
the agreements, the nature and significant terms of those agreements,
including the rights
and obligations of each party and any commitments and contingencies
with respect to the
agreements. Tell us your consideration of providing additional
disclosure in the filing in
accordance with ASC 450, 730, and 808; Items 101, 303, and 601 of
Regulation S-K; and
any other applicable guidance.
7. With respect to your historical business discussed on page 42 and
elsewhere in your filing,
clarify the dates in which you completed significant research and
development
milestones. Tell us your consideration of providing additional
disclosure in the filing. For
example, tell us when you completed the Phase IIb clinical trial of
AE37
immunotherapeutic peptide vaccine with the Ii-Key technology in over
300 women with
breast cancer.
Note 12- Goodwill and Intangible Assets, page 100
8. With respect to your acquisition of Veneto on October 3, 2018 we note
the following:
You state on page 66 that you are currently in litigation with
Veneto regarding the
assets and business transferred, many of the contractual
arrangements you assumed
have been terminated, and you have had to rebuild the business
relationships and the
structure of the contractual relationships you took over from
Veneto. You also state
on page 45 that the MSO was built through relationships between
physicians and the
previous Veneto administration.
Joseph Moscato
FirstName LastNameJoseph Moscato
GENEREX BIOTECHNOLOGY CORP
Comapany2020
March 25, NameGENEREX BIOTECHNOLOGY CORP
Page 4
March 25, 2020 Page 4
FirstName LastName
You state on page 69 that the arbitration action alleges that
Veneto never transferred
the ownership rights in at least one pharmacy to NDS and that
pharmacy was a
necessary element in the operation of other assets transferred by
Veneto.
You state on page 94 that certain assets were never transferred due
to regulatory
impositions and that NuGenerex is not responsible for repayment
of a loan on assets
not transferred.
You state on page 85 that in March 2019 you changed your business
model to no
longer utilize their existing pharmacies which resulted in you
breaking your existing
lease agreements with your pharmacies. In this respect we note
your disclosure on
page 95 which states that $292,681 of disposals pertain to Veneto
and was mostly the
result of your shift in business operations during March 2019.
You disclose on page 105 that you revalued the assets during the
measurement period in
accordance with ASC 805-10-25-14 and reduced goodwill accordingly.
However your
disclosure, as noted above, appears to imply that the assets recorded
may need further
consideration, including potentially an impairment for events
occurring after the
acquisition date such as the change in your business model. Please
provide us your
analysis regarding the valuation of the assets recorded in connection
with the Veneto
acquisition, including goodwill. Your analysis should at a minimum
include the
following:
the nature of each significant asset acquired in the acquisition,
the status of ownership and rights for each significant asset at the
time of the
acquisition and at your balance sheet date,
how each asset was affected by your change in business model,
how each asset was affected by any terminated contractual
arrangements,
the extent to which you have had to rebuild business relationships,
including the
network of physician partners in the MSO acquired from Veneto,
and
the effect of the ongoing litigation with Veneto
Note 13 - Acquisitions
Veneto, page 104
9. You appear to consolidate the assets acquired of Veneto. You state on
page 45 the MSO
acquired from Veneto is named Rapport Services, LLC ("Rapport"), which
is a physician-
owned limited liability company (or LLC) requiring an at-risk equity
investment from
physicians or physician groups that wish to participate in the
network. The Rapport
physician investors own 99% of Rapport, and Generex (through your
wholly-owned
subsidiary NuGenerex Distribution Solutions 2) owns 1% and serves as
the managing
director of the LLC. Please provide us with your analysis as to why
consolidation is
consistent with ASC 810. If Veneto is not considered a variable
interest entity, please
provide your assessment of consolidation under the entities controlled
by contract in ASC
810-10-25-60.
Regentys and Olaregen, page 106
Joseph Moscato
FirstName LastNameJoseph Moscato
GENEREX BIOTECHNOLOGY CORP
Comapany2020
March 25, NameGENEREX BIOTECHNOLOGY CORP
Page 5
March 25, 2020 Page 5
FirstName LastName
10. Please provide us the following with respect to the $2,459,000 of
in-process research and
development recorded in the Olaregen acquisition and $3,391,050
acquired in the
Regentys acquisition:
the specific nature and fair value of each significant in-process
research and
development project acquired.
the completeness, complexity and uniqueness of the projects at the
acquisition date.
the nature, timing and estimated costs of the efforts necessary to
complete the
projects, and the anticipated completion dates.
the risks and uncertainties associated with completing development
on schedule, and
consequences if it is not completed timely.
what appraisal method was used to value the projects.
the significant appraisal assumptions, such as:
o the period in which material net cash inflows from
significant projects are
expected to commence;
o material anticipated changes from historical pricing, margins
and expense
levels; and
o the risk adjusted discount rate applied to the project's cash
flows.
In periods subsequent to the purchase of significant in-process
research and
development, tell us the status of efforts to complete all of your
significant in-process
research and development projects, including those other than the
assets acquired in
the Olaregen and Regentys acquisitions, and the impact of any
delays on your
expected investment return, results of operations and financial
condition.
Regentys, page 107
11. You state that you acquired a 51% interest in Regentys for total
consideration of
$15,000,000, which consisted of a $400,000 cash payment and a
promissory note of
$14,600,000. Please provide us the following:
a calculation of how the non-controlling interest of $9,870,762 was
determined,
an analysis of the methodology and assumptions used as described on
page 108 to
determine the redeemable non-controlling interest of $4,073,898
were determined,
and
how the fair value of the assets acquired of $907,833 equates to the
amount of the
assets disclosed in the table on page 107.
Olaregen, page 108
12. You state on pages 5 and 109 that in January 2019 you acquired a 51%
interest in
Olaregen for total consideration of $400,000 of cash and a note
receivable of
$11,472,664. You state on page 113 that your interest was increased to
62% in May 2019
upon acquisition of the Series A preferred stock in Olaregen in
exchange for 4 million
shares of your common stock plus the issuance of a $2 million
promissory note. In
August 2019, subsequent to your balance sheet date, your interest
increased to 76%.
Joseph Moscato
GENEREX BIOTECHNOLOGY CORP
March 25, 2020
Page 6
Please provide us the following:
a calculation of how the non-controlling interest was determined,
how the fair value of the assets acquired of $2,461,400 equates to
the amount of the
assets disclosed in the table on page 109, and
how you are accounting for the additional interest purchased in May
and August
2019.
Item 9A. Controls and Procedures, page 114
13. You state in your Management's Report on Internal Control Over
Financial Reporting on
page 115 that you have evaluated the effectiveness of your disclosure
controls and
procedures and concluded that your disclosure controls and procedures
were not
effective. Please present your assessment of the effectiveness of the
disclosure controls
and procedures under the subheading for "Evaluation of Disclosure
Controls and
Procedures" and a separate assessment relating to your assessment of
internal controls
over financial reporting under the Management's Report on Internal
Control over
Financial Reporting subheading. Refer to Items 307 and 308 of
Regulation S-K. Please
also revise your Risk Factor on page 42 to address your determination
of effectiveness
of the disclosure controls and procedures and internal control over
financial reporting
separately.
14. You refer to a restatement which was included in your Form 10-Q/A for
the period ended
January 31, 2019. In this respect, please tell us the basis for
eliminating the intercompany
revenue of $1,406,529 against the general and administrative expenses
as noted on page
12 of the 10-Q/A.
In closing, we remind you that the company and its management are
responsible for the
accuracy and adequacy of their disclosures, notwithstanding any review,
comments, action or
absence of action by the staff.
You may contact Mary Mast 202-551-3613 or Dan Gordon at 202-551-3486
with any
questions.
FirstName LastNameJoseph Moscato Sincerely,
Comapany NameGENEREX BIOTECHNOLOGY CORP
Division of Corporation Finance
March 25, 2020 Page 6 Office of Life Sciences
FirstName LastName