OSIRIS THERAPEUTICS,INC. (OTCMKTS:OSIR) Files An 8-K Results of Operations and Financial Condition
Item 2.02. Results of Operations and Financial Condition.
On March27, 2017, Osiris Therapeutics,Inc. (the Company) filed an
amendment (the Form10-K/A) to its Annual Report on Form10-K for
the year ended December31, 2014. The Form10-K/A includes restated
financial statements as of and for the year ended December31,
2014. As a result of the filing of the Form10-K/A, the Company
intends to formally engage Ernst Young LLP as its new independent
registered public accounting firm, subject to completion of its
standard client acceptance procedures which are ongoing.
On November7, 2016, the Company issued a press release announcing
its preliminary revenue expectations of approximately $46 million
to $50 million and $85 million to $90 million for the years ended
December31, 2014 (restated) and December31, 2015, respectively,
and also that it expected revenue for the year ended December31,
2016 to be between $100 million and $110 million. In the
Form10-K/A, the Company reported revenue of $50.8 million for
2014. On March27, 2017, the Company issued a press release
announcing, among other things, that it currently expects to
report revenue of approximately $89 million to $92 million for
2015 and approximately $110 million to $114 million for 2016.
Item 7.01. Regulation FD.
On March1, 2017, the Company, together with Peter Friedli, Jay M.
Moyes, Thomas M. Brandt and Yves Huwyler (the Directors and
together with the Company, the Defendants) entered into a
Settlement Agreement (the Settlement Agreement) with Brian C. Lee
(the Plaintiff) regarding the settlement of a shareholder
complaint filed in the Circuit Court for Howard County Maryland
(the Court) against the Defendants captioned Brian C. Lee v.
Osiris Therapeutics,Inc., et al., No.13-C-16108356. The
Plaintiff alleged that the Defendants failed to schedule or hold
an annual meeting within the time period allegedly required by
the Companys bylaws and Maryland law. The Company was not able to
hold its annual meeting in 2016 due to the pending restatement of
its financial statements.
to the terms of the Settlement Agreement, without agreeing that
any of the claims in the lawsuit have merit or that any
disclosure is required under any applicable statute, rule,
regulation or law, the Company has agreed to make available
certain additional information to the Companys shareholders, as
disclosed in this Current Report on Form8-K, and the Plaintiff
has agreed to settle the lawsuit and release the Defendants from
all related claims. The Settlement Agreement further provides for
the voluntary dismissal of the outstanding litigation with
prejudice.
Without admitting in any way that the disclosures below are
material or otherwise required by law, the Company makes the
following disclosures:
Updated Revenue Estimates
(Unaudited)
As noted above, the Company currently expects to report revenue
of approximately $89 million to $92 million for 2015 and
approximately $110 million to $114 million for
2016.
Total Assets, Total Debt, and Cash Information
(Unaudited)
As of December31, 2016, the Company had between $72 million and
$75 million in total assets and $27 million in cash and cash
equivalents. The Company has no debt other than a capital lease
obligation of approximately $20,000 which expires in 2017.
Security Ownership of Certain Beneficial Owners
and Management
The following table sets forth certain information with respect
to the beneficial ownership of the Companys common stock as of
March27, 2017 for (a)each of the Companys directors and each
person currently serving as Chief Executive Officer or Chief
Financial Officer and the other most highly compensated executive
officers (the named executive officers), (b)all of the Companys
current directors and named executive officers as a group, and
(c)each stockholder that it knows to be the beneficial owner of
more than 5% of the Companys
common stock. Beneficial ownership is determined in accordance
with the rulesof the SEC and includes voting or investment
power with respect to the securities. The Company deems shares
of common stock that may be acquired by an individual or group
within 60 days of March27, 2017 to the exercise of options to
be outstanding for the purpose of computing the percentage
ownership of such individual or group, but those shares are not
deemed to be outstanding for the purpose of computing the
percentage ownership of any other person shown in the table.
Except as indicated in footnotes to this table, the Company
believes that the stockholders named in this table have sole
voting and investment power with respect to all shares of
common stock shown to be beneficially owned by them based on
information provided to the Company by these stockholders.
Percentage of ownership is based on 34,525,886 shares of common
stock outstanding on March27, 2017.
NameandAddressofBeneficialOwners |
|
Amountand Natureof Beneficial Ownership |
|
Percentof Class(2) |
|
Named Executive Officers and |
|||||
Thomas M. Brandt |
|
||||
Alla Danilkovitch |
78,450 |
(3) |
|||
David A. Dresner |
25,000 |
||||
Peter Friedli |
14,810,455 |
(4) |
42.9 |
% |
|
Yves Huwyler |
51,072 |
(5) |
|||
Thomas J. Knapp |
|
||||
Gregory I. Law |
10,100 |
(6) |
|||
Adrian P. Mollo |
12,500 |
(7) |
|||
Jay M. Moyes |
13,250 |
||||
Uwe Sommer |
108,500 |
||||
All directors and executive officers as a group |
15,109,327 |
43.8 |
% |
||
Other 5% Stockholders |
|||||
Venturetec,Inc. c/o Osiris Therapeutics,Inc. 7015 Albert |
4,103,301 |
11.9 |
% |
||
Thomas Schmidheiny Zurcherstrasse 156 8645 Jona |
3,060,767 |
(8) |
8.9 |
% |
|
BIHSA 3 Fauboug deHopital 2000 Neuchatel, Switzerland |
2,658,113 |
7.7 |
% |
(1) Mailing address for all directors and officers is c/o
Osiris Therapeutics,Inc., 7015 Albert Einstein Drive, Columbia,
Maryland 21046.
(2) Percentage not provided if less than 1%.
(3) Represents 66,500 shares issuable upon exercise of options.
Mr.Danilkovitch separately has 22,500 options that have not yet
vested.
(4) Consists of 10,204,404 shares owned directly by Peter
FriedliCo.,Inc., 4,103,301 shares held by Venturetec,Inc.,
500,000 shares held by Mr.Friedlis minor daughter and 2,750
shares held by his spouse. Mr.Friedli is the sole owner of
Peter FriedliCo.,Inc. and serves as its president. Mr.Friedli
holds approximately a 2% interest in the parent of
Venturetec,Inc. and through ownership of a convertible note
holds another 19% interest in Venturetec,Inc., for which he
serves as president. Mr.Friedli has disclaimed beneficial
ownership in the shares held by his daughter and spouse and has
disclaimed beneficial interest in the shares held by
Venturetec,Inc., beyond the extent of his pecuniary interest
therein.
(5) Includes 400 shares held by Mr.Huwylers minor children.
(6) Represents 10,000 shares issuable upon exercise of options.
Mr.Law separately has 10,000 options that have not yet vested.
(7) Represents 12,500 shares issuable upon exercise of options.
Mr.Mollo separately has 12,500 options that have not yet
vested.
(8) Consists of 402,654 shares owned directly by Mr.Schmidheiny
and 2,658,113 shares owned by BIH SA. Mr.Schmidheiny is the
Chairman and controlling shareholder of BIH SA.
Related Person Transactions
As required by the Companys Corporate Governance Principles,
the Audit Committee (the Audit Committee) of the Companys Board
of Directors (the Board) reviews and approves in advance all
related person transactions, as defined by SEC rules. The
Companys policy with respect to related person transactions is
incorporated within the Audit Committee Charter, a copy of
which is available on the Companys website at
http://investor.osiris.com/documents.cfm.
The Audit Committee may approve only those related party
transactions that are in, or are not inconsistent with, the
best interests of the Company and its stockholders, as the
Audit Committee determines in good faith. In making such a
determination, the Audit Committee is required to consider all
of the relevant facts and circumstances relating to the
transaction including, but not limited to, the following:
the benefits to the Company;
if the transaction involves a director, a member of the
directors immediate family or entity affiliated with the
director, the impact on the directors independence;
the availability of other sources for comparable products or
services;
the terms of the transaction; and
the terms available to unrelated third parties.
The following were the related person transactions of the
Company during 2015:
Prolexys Pharmaceuticals,Inc.During the third quarter
of fiscal 2011 the Company entered into a contract research
agreement with Prolexys Pharmaceuticals,Inc. (Prolexys) under
which the Company is conducting for Prolexys an early stage
clinical trial investigating a novel compound as a product
candidate for cancer therapeutics. This contract was filed as
an exhibit to and discussed in a Current Report on Form8-K
filed by the Company with the SEC on September14, 2011
primarily because of the related nature of the management and
ownership of Prolexys with the Company and is management and
with certain of its significant stockholders, and not because
the Companys rights or obligations under the contract research
agreement with Prolexys are otherwise material to the Company.
The Company did not incur any third party costs related to its
work with Prolexys and it was primarily contributing only the
efforts of employees. All third party costs associated with the
Prolexys clinical trial and related work were paid directly by
Prolexys. The amount of internal resources the Company
contributed to Prolexys was not material. During 2015, the
clinical trial ended and the Company ceased contributing
efforts of its employees to Prolexys and the agreement with
Prolexys was terminated during 2016. This arrangement was part
of the Companys efforts to expand is portfolio of product
candidates, but it never considered this arrangement to be
material to the Company.
Prolexys is 35.7% owned by BIHSA, which owns 7.7% of the
Companys outstanding common stock; 24.3% owned by Peter Friedli
who is the Chairman of the Board and direct owner of 29.6% of
the Companys common stock; and 13.8% owned by Venturetec,Inc.,
which holds 11.9% of the Companys common stock. Peter Friedli
is the President and an approximately 2% owner of
Venturetec,Inc. YvesHuwyler, who serves on the Companys Board,
owns less than 1% of Prolexys and serves on its board of
directors.
The Board and Audit Committee, including all of the Companys
independent directors, but with Mr.Friedli abstaining,
unanimously approved this transaction.
BioForceRX LLC. The Company paid BioForceRX LLC, a
professional recruiting and consulting firm, approximately
$129,500 in 2015 for various recruiting services, primarily
involving the Companys sales force. The owner of BioForceRX LLC
is Kathleen Czworka, the spouse ofFrank Czworka, the Companys
former Vice President and General Manager of Wound Care from
August2011 to February2016. Mr.Czworka was also served as the
Companys Chief Operating Officer from February2, 2016 until
March6, 2016 when the Chief Operating Officer position was
eliminated.
Ongoing Search for Permanent Chief Executive
Officer
As previously reported, the Company is conducting a search to
identify a permanent Chief Executive Officer. On June10, 2016,
the Company announced that the Board had appointed David A.
Dresner to serve as Interim President and Chief Executive
Officer.
SEC and U.S. Attorneys Office
Investigations
As disclosed in the Companys Current Report on Form8-K filed on
March15, 2016, the Company has received a subpoena from the SEC
relating to a non-public investigation relating to its historic
accounting practices, which have been under independent review
(the Independent Review) by the Audit Committee with the
assistance of outside professionals. Counsel to the Audit
Committee also has voluntarily advised the SEC about the
Independent Review. The Company is cooperating fully with the
SEC in this matter.
As disclosed in the Companys Current Report on Form8-K filed on
May27, 2016, the Company has been advised by the United States
Attorneys Office for the Southern District of New York (the
U.S. Attorney) that a criminal investigation has been opened by
that office into what the Company understands to be the matters
of the SEC Investigation. The Company is cooperating fully with
the U.S. Attorney in this matter.
Forward Looking Statements
Certain matters discussed in this Current Report on
Form8-Kconstitute forward-looking statements within the meaning
of the Private Securities Litigation Reform Act of
1995.Theseforward-looking statements are based on managements
current beliefs, assumptions and expectations regarding future
events, which in turn are based on information currently
available to management.Such forward-looking statements include
statements regarding the timing or outcome of pending legal
proceedings and government investigations, the Companys
estimated range of revenues for 2015 and 2016, the timing or
outcome of the Companys search for a permanent Chief Executive
Officer and the timing or outcome of the restatements,
including the materiality, significance, nature, subject
matter, timing or quantitative effects of the Companys restated
financial statements. The Company cautions you not to place
undue reliance on any such forward-looking statements.Several
factors could cause actual results to differ materially from
those expressed in or contemplated by the forward-looking
statements.Such factors include, but are not limited to, the
identification of additional errors in the restatement process,
changes in the scope or focus of the accounting adjustments,
the risk that additional information may arise prior to the
expected filing with the SEC of the restated financial
statements and the 2015 and 2016 financial statements, the
outcome of the presently pending investigations by SEC and U.S.
Department of Justice, or subsequent events that would require
us to make adjustment. Other risk factors affecting the Company
are discussed in detail in the Companys filings with the SEC,
including its Annual Reports on Form10-K.The Company undertakes
no obligation to publicly update or revise any forward-looking
statement, whether as a result of new information, future
events or otherwise, except as required by law.
About OSIRIS THERAPEUTICS, INC. (OTCMKTS:OSIR)
Osiris Therapeutics, Inc. is a cellular and regenerative medicine company. The Company is focused on researching, developing and marketing products in the wound, orthopedic, and sports medicine markets. The Company operates through Biosurgery business segment, which focuses on products for wound care, orthopedics, and sports medicine to harness the ability of cells and novel constructs to promote the body’s natural healing. The Company’s products include Grafix, Stravix, TruSkin, Cartiform and BIO4. The Company produces and distributes Grafix for acute and chronic wounds; Stravix for tendon repair; TruSkin for wound closure; Cartiform, a viable cartilage mesh for cartilage repair, and BIO4 for bone growth. The Company’s BioSmart cryopreservation process retains the native characteristics and inherent functionality of tissue. Its BioSmart process includes preservation of the three dimensional (3D) matrix, endogenous growth factors, and tissue-resident cells. OSIRIS THERAPEUTICS, INC. (OTCMKTS:OSIR) Recent Trading Information
OSIRIS THERAPEUTICS, INC. (OTCMKTS:OSIR) closed its last trading session up +0.02 at 3.95 with 2,921,453 shares trading hands.