SEC Company Response from Galmed Pharmaceuticals Ltd. (GLMD) (CIK 0001595353) (EOCN) — Feb 28, 2014
Galmed Pharmaceuticals Ltd. (GLMD) (CIK 0001595353)
Date: Feb. 28, 2014 · CIK: 0001595353 · Accession: 0001144204-14-012617
AI Filing Summary & Sentiment
File numbers found in text: 333-193792
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GALMED
PHARMACEUTICALS LTD.
8 Shaul Hamelech Blvd.
Amot Hamishpat Bldg.
Tel Aviv, Israel 64733
February 28, 2014
VIA EDGAR AND FEDERAL EXPRESS
Securities and Exchange Commission
100 F. Street, N.E.
Washington, DC 20549
Attn: Jeffrey P. Riedler, Assistant Director
Re: Galmed Pharmaceuticals Ltd.
Registration Statement on Form F-1
Filed February 6, 2014
File No. 333-193792
Dear Mr. Riedler:
On behalf of Galmed Pharmaceuticals
Ltd., an Israeli limited company (the “Company”), I am writing to respond to the comments of the staff (the
“Staff”) of the United States Securities and Exchange Commission (the “SEC”) contained in
its letter to the Company, dated February 24, 2014, regarding the Company’s Registration Statement on Form F-1, filed with
the SEC on February 6, 2014 (File No. 333-193792) (the “Registration Statement”).
Concurrently with this
response, the Company is also publicly filing Amendment No. 1 to the Registration Statement (the “Amendment No. 1”),
which reflects the revisions to the Registration Statement described herein. To expedite your review, we have enclosed with this
letter a clean copy of Amendment No. 1, as well as a marked copy of the Amendment No. 1 showing all changes from the Registration
Statement.
For your convenience,
we have set forth the text of each of the Staff’s comments in bold, followed in each case by the Company’s response
thereto.
1
Critical Accounting Policies and Estimates
Stock-Based Compensation and Fair Value of Ordinary Shares, page 59
1. Please refer
to prior comment 13 and address the following additional comments:
• Please
separately tell us the estimated fair value per share of your common stock and the estimated fair value of each option at each
grant date.
• Please
separately provide us a description and quantification of the transactions that serve as a basis for your valuations, as “based
on the purchase price paid by new external and independent investors with pharmaceutical or financial expertise in our convertible
notes or around the time of our equity issuances” is vague.
• Please
separately provide us a more informative explanation of the specific factors that caused the fair value of your common stock to
change from each grant date, such as the “progress in the clinical development of our product candidates, submissions of
new families of patent applications, new formulations of our product candidate and an investment round.”
• Please
revise your disclosure to specifically highlight that the estimates of fair value you have made are highly complex and subjective.\
• Please
revise your disclosure to specifically highlight that the estimates of the fair value of your common stock will not be necessary
to estimate the fair value of new awards once the underlying shares begin trading.
Please note that we are deferring
a final evaluation of stock compensation and other costs recognized until the amendment containing the estimated offering price
is filed.
Company’s
Response:
The Company has revised
its disclosure to specifically highlight that the estimates of fair value that the Company has made are highly complex and subjective.
The Company has also revised its disclosure to specifically highlight that the estimates of the fair value of the Company’s
ordinary shares will not be necessary to estimate the fair value of new awards once the underlying shares begin trading. See page
59 of Amendment No. 1.
In addition to the
revised disclosure addressing the Staff’s comments above, with respect to each of the bullet points reproduced below, the
Company separately advises the Staff as follows:
• Please
separately tell us the estimated fair value per share of your common stock and the estimated fair value of each option at each
grant date.
The estimated fair
value per share of the Company’s ordinary shares and the estimated fair value of each option at each grant date are as follows:
2
Grant date
Number of options granted
Estimated fair value per share at grant date
Estimated fair value of each option at grant date
Notes
February 2002
53
$ 1,075.47
$ 832.00
January 2012
110
2,601.41
962.00
January 2012
110
2,601.41
1,066.00
January 2012
111
2,601.41
1,159.00
January 2012
331
2,601.41
831.00
1
December 2013
202
7,244.41
5,531.00
December 2013
12
7,244.41
6,465.00
December 2013
120
7,244.41
6,819.00
December 2013
120
7,244.41
6,879.00
December 2013
120
7,244.41
6,879.00
December 2013
321
7,244.41
6,979.00
December 2013
778
7,244.41
7,244.00
1
The warrants were issued with several performance conditions. The Company estimated that the conditional performances set forth in the agreement would not be met and accordingly did not record expenses attributable to those warrants. The warrants expired in May 2013.
• Please
separately provide us a description and quantification of the transactions that serve as a basis for your valuations, as “based
on the purchase price paid by new external and independent investors with pharmaceutical or financial expertise in our convertible
notes or around the time of our equity issuances” is vague.
The following sets
forth a description and quantification of the transactions that serve as a basis for the Company’s valuations:
Grant date
Number of options granted
Notes
February 2002
53
1
January 2012
331
2
January 2012
331
3
December 2013
1,673
4
1
The Company determined the estimated fair value per share at the grant date on the basis of the initial issuance of ordinary shares in September 2000, which reflected a valuation of the Company of $4,500,000 (or $1,075.47 per share).
3
2
The warrants were issued with several performance conditions. The Company estimated that the conditional performances set forth in the agreement would not be met and accordingly did not record expenses attributable to those warrants. The warrants expired in May 2013.
3
The Company determined the estimated fair value per share at the grant date on the basis of capital notes issued, which occurred on the same date and which reflected a valuation of the Company of $25,000,000 (or $2,601.41 per share).
4
The Company determined the estimated fair value per share at the grant date, which reflected a valuation of the Company of $80,000,000 (or $7,244.41 per share), on the basis of its agreement with the underwriters for purposes of the engagement letter with the underwriters, which was executed in November 2013.
• Please
separately provide us a more informative explanation of the specific factors that caused the fair value of your common stock to
change from each grant date, such as the “progress in the clinical development of our product candidates, submissions of
new families of patent applications, new formulations of our product candidate and an investment round.”
The following sets
forth a more informative explanation of the specific factors that caused the fair value of the Company’s ordinary shares
to change from each grant date:
The Company believes
that the following events, which occurred between October 2000 and February 18, 2002, were among the factors that caused the fair
value of the Company’s ordinary shares to increase during such period from $1,000 per share (at the time of the execution
of the Company’s founders agreement) to $1,075 per share (at the time of a certain option grant on February 18, 2002).
Event
Date
Research agreement with Ichiliv Hospital and Prof. Zamir Halperin - preclinical studies of FABACs
December 27, 2000
Research agreement with CJ Conciel - Laboratory examinations of FABACs
January 8, 2001
Research agreement with Daren Laboratories Stage I of scaled up synthesis of FABACs
November 5, 2001
The Company believes
that the following events, which occurred between February 18, 2002 and January 2012, were among the factors that caused the fair
value of the Company’s ordinary shares to increase during such period from $1,075 per share (at the time of a certain option
grant on February 18, 2002) to $2,061.41 per share (at the time of the initial grant of the Warrant (as defined in the Registration
Statement)).
4
Event
Date
Filing of patent application in the United States, Europe and other countries
April 15, 2002
Grant of patent in the United States
May 7, 2002
Grant of patent in the United States
May 28, 2002
Grant of patent in Europe
August 28, 2002
Settlement Agreement between Galmed International Limited and Aventis Pharma Deutschland GmbH
October 10, 2002
Grant of patent in the United States
July 8, 2003
Grant of patent in Europe
June 20, 2007
Pre-IND meeting with the FDA
November 26, 2007
Following the Helsinki Committee approval, an approval of the Central Committee for Clinical Trials in Human Subjects (Phase I)
July 2, 2008
Filing of patent in the United States
January 28, 2009
Grant of patent in the United States
March 10, 2009
Grant of patent in Europe
June 3, 2009
Aramchol was selected as one of the top 10 most interesting projects to be presented at Windhover Partnerships meeting
September 15, 2009
Successful Completion of Initial Phase I Study of Aramchol
October 2009
Filing of patent application in the United States, Europe and other countries
February 1, 2010
Following the Helsinki Committee approval, an approval of the Central Committee for Clinical Trials in Human Subjects (Phase II)
April 28, 2010
Bridge Loans ($1.8 million)
2009-2011
The Company believes
that the following events, which occurred between January 2012 and December 22, 2013, were among the factors that caused the fair
value of the Company’s ordinary shares to increase during such period from $2,601.41 per share (at the time of the initial
grant of the Warrant (as defined in the Registration Statement)) to $7,244.41 per share (at the time of certain option grants to
members of senior management).
5
Event
Date
Convertible Loan Agreement ($3.7 million)
January 2012
Grant of patent in the United States
February 7, 2012
Completion of the Phase IIa study – aramchol protocol no. 003
March 2012
Invitation to present the study results as late-breaker news at the International Liver Congress EASL 2012 in Barcelona, Spain
April 18, 2012 - April 22, 2012
Memorandum of Understanding between Enterome Bioscience and Galmed Medical Research Ltd.
October 30, 2012
Filing of patent application in the United States - Submission of new pending patents for salts which are new composition of matter are also important as they prolong the patents life of the company by 20 years
December 4, 2013
Convertible Security Notes ($1.8 million)
August-September 2013
Conversion of all outstanding amount under the Bridge Loans ($1.8 million) and the Convertible Loan Agreement ($3.7 million)
December 22, 2013
Share Purchase Agreement with Shirat HaChaim Ltd. ($120,000)
December 31, 2013
2. Please provide
us a calculation supporting your stock-based compensation expense recognized in the fourth quarter of 2013 of $10.9 million.
Company’s
Response:
The Company’s
stock-based compensation expense recognized in the fourth quarter of 2013 of $10.9 million was calculated as follows:
6
Grant date
Number of options granted
Exercise price
Vesting period
Estimated fair value per share at grant date
Fair value of each option at grant date
Compensation expense recognized in fiscal year ended December 31, 2013
Compensation expense recognized in the nine months ended September 30, 2013
Compensation expense recognized in the three months ended December 31, 2013
Notes
February 2002
53
$ 1,075.47
Fully vested
$ 1,075.47
$ 832
$ -
$ -
$ -
January 2012
110
2,601.41
Over one year
2,601.41
962
-
-
-
January 2012
110
2,601.41
Over two years
2,601.41
1,066
58,478
44,125
14,353
January 2012
111
2,601.41
Over three years
2,601.41
1,159
43,127
31,959
11,168
January 2012
331
2,601.41
Performance-based conditions
2,601.41
831
-
-
-
1
December 2013
202
2,601.41
Fully vested
7,244.41
5,628
1,136,955
-
1,136,955
December 2013
12
923.20
Fully vested
7,244.41
6,465
78,232
-
78,232
December 2013
120
461.60
Fully vested
7,244.41
6,851
822,073
-
822,073
December 2013
120
390.00
Fully vested
7,244.41
6,907
828,861
-
828,861
December 2013
120
390.00
Over two years
7,244.41
6,907
-
-
-
December 2013
321
276.96
Fully vested
7,244.41
7,000
2,246,930
-
2,246,930
December 2013
778
0.01
Fully vested
7,244.41
7,244
5,636,146
-
5,636,146
10,850,802
76,084
10,774,718
1
The warrants were issued with several performance conditions. The Company estimated that the conditional performances set forth in the agreement would not be met and accordingly did not record expenses attributable to those warrants. The warrants expired in May 2013.
7
Business
Historical Background and Corporate Structure, page 109
3. The Reorganization,
completed on February 2, 2014, transferred the ownership of the biopharmaceutical business and subsidiary holdings of Galmed Holdings,
Inc. to Galmed Pharmaceuticals, Ltd. Your disclosure on page 129, which states that options were issued “to purchase 1,463
shares of GHI (or 1,066,527 of our ordinary shares),” appears to indicate the existence of a share exchange ratio in the
Reorganization. Please describe and quantify this share exchange ratio and the related impact on all share and per share amounts
as disclosed in your filing. Please tell us how you intend to reflect the Reorganization in the historical financial statements
you present in your filing and reference for us the authoritative literature you rely upon to support your presentation. In your
response, at a minimum, please specifically tell us how you intend to present your historical earnings per share and equity information
as well as your capitalization table and dilution disclosures.
Company’s
Response:
The Staff is respectfully
advised that as part of the Reorganization (as defined in the Registration Statement) and in preparation for the upcoming offering,
the Company was capitalized based on an identical share and ownership structure and holdings as Galmed Holdings Inc. (“GHI”),
and contemporaneously the Company effected a stock split of 729:1. See pages 7, 109 and 129 of Amendment No. 1. On February 2,
2014, the Company succeeded to all of GHI’s operations. The Reorganization is considered a restructuring under common control
to be accounted for using historical carrying amounts. The Staff is advised that the Company (which is also the successor to GHI)
is the entity that effected the 729:1 stock split, and such split should be reflected in the Company’s books retroactively.
Because, as of the balance sheet date (i.e., December 31, 2013), the Company had not yet suc