OPKO Health, Inc.
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(Mark One)
x QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended June 30, 2007.
OR
o TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from ________ to ________.
Commission file number 000-27748
OPKO Health, Inc.
(Exact Name of Registrant as Specified in Its Charter)
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Delaware
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75-2402409 |
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer Identification No.) |
4400 Biscayne Blvd., Suite 1100
Miami, FL 33137
(Address of Principal Executive Offices)
(305) 575-6015
(Registrants Telephone Number, Including Area Code)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. YES x NO o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated
filer, or a nonaccelerated filer (as defined in Rule 12b-2 of the Exchange Act). Check one:
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Large accelerated filer o
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Accelerated filer o
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Nonaccelerated filer x |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act):
YES o NO x
As of
August 6, 2007, the registrant had 161,020,191 shares of common stock outstanding.
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Exhibit 31.1
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Certification by Phillip Frost, MD, Chief Executive Officer, pursuant
to Rule 13a-14(a) or 15d-14(a) of the Securities and Exchange Act of
1934 as adopted pursuant to Section 302 of the Sarbanes-Oxley Act
of 2002 for the quarterly period ended June 30, 2007. |
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Exhibit 31.2
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Certification by Rao Uppaluri, Chief Financial Officer, pursuant
to Rule 13a-14(a) or 15d-14(a) of the Securities and Exchange Act of
1934 as adopted pursuant to Section 302 of the Sarbanes-Oxley Act
of 2002 for the quarterly period ended June 30, 2007. |
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Exhibit 32.1
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Certification by Phillip Frost, MD, Chief Executive Officer, pursuant to
18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002 for the quarterly period ended June 30, 2007. |
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Exhibit 32.2
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Certification by Rao Uppaluri, Chief Financial Officer, pursuant to
18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002 for the quarterly period ended June 30, 2007. |
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Exhibit 99.1
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Financials of Ophthalmic
Technologies, Inc. |
3
PART I. FINANCIAL INFORMATION
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
The statements set forth under the captions Managements Discussion and Analysis of Financial
Condition and Results of Operations, and Risk Factors, and other statements included elsewhere
in this Quarterly Report on Form 10-Q, which are not historical, constitute Forward Looking
Statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding the
expectations, beliefs, intentions or strategies for the future. When used in this report, the terms
anticipate, believe, estimate, expect and intend and words or phrases of similar import,
as they relate to our or our subsidiaries or our management, are intended to identify
forward-looking statements. We intend that all forward-looking statements be subject to the
safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. These
forward-looking statements are only predictions and reflect our views as of the date they are made
with respect to future events and financial performance. Forward-looking statements are subject to
many risks and uncertainties that could cause our actual results to differ materially from any
future results expressed or implied by the forward-looking statements.
Examples of the risks and uncertainties include, but are not limited to the following:
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the inherent risks and uncertainties in developing drugs and products of the type we are developing; |
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we are highly dependent on the success of our lead product candidate, bevasiranib, and we cannot
give any assurance that it will receive regulatory approval or be successfully commercialized; |
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the results of previous clinical trials may not be predictive of future results, and our current
and planned clinical trials may not satisfy the requirements of the FDA or other non-U.S.
regulatory authorities; |
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delays in our preparation and filing of applications for regulatory approval; |
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delays in the approval or potential rejection of any applications we file with the FDA, or other
health regulatory authorities; |
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any lack of progress of our research and development (including the results of clinical trials
being conducted by us); |
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obtaining on a timely basis sufficient patient enrollment in our clinical trials; |
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the impact of development of competing therapies and/or technologies by other companies; |
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our ability to obtain additional financings required to fund our research programs; |
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the risk that we will not be able to develop a successful sales and marketing organization in a
timely manner, if at all; |
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our ability to establish and maintain strategic license, collaboration and distribution
arrangements and to manage our relationships with collaborators, distributors and partners; |
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as we evolve from a company primarily involved in development to a company also involved in
commercialization, we may encounter difficulties in managing our growth and expanding our
operations successfully; |
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potential product liability risks and risks of securing adequate levels of product liability and
clinical trial insurance coverage; |
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the availability of reimbursement to patients from healthcare payors for procedures in which our
products are used; |
4
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the possibility of infringing a third partys patents or other intellectual property rights; and |
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the uncertainty of obtaining patents covering our products and processes and in successfully
enforcing them against third parties. |
In addition, companies in the pharmaceutical and biotechnology industries have suffered significant
setbacks in advanced clinical trials, even after obtaining promising earlier trial results. These
and other risks and uncertainties are detailed in our Current Report on Form 8-K dated March 27,
2007 and described from time to time in our future reports filed with the Securities and Exchange
Commission. We undertake no obligation to update, and we do not have a policy of updating or
revising, these forward-looking statements.
5
Item 1. Financial Statements:
The results of operations for the first six months of 2007 include Froptix operating results for
the full six month period and Acuitys operating results subsequent to March 27, 2007. As a result
of the reverse merger, historical comparative results are those of Froptix. Froptix was
incorporated on June 23, 2006 and did not have significant operations for most of the first six
months of 2006.
OPKO Health, Inc.
CONDENSED CONSOLIDATED BALANCE SHEETS
(A Development-Stage Company)
(in thousands except share data)
|
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June 30, |
|
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December 31, |
|
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2007 |
|
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2006 |
|
|
|
(unaudited) |
|
ASSETS |
|
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|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
6,183 |
|
|
$ |
116 |
|
Prepaid expenses and other current assets |
|
|
501 |
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
6,684 |
|
|
|
116 |
|
Property and equipment, net |
|
|
98 |
|
|
|
|
|
Investment in Ophthalmic Technologies, Inc. (OTI) |
|
|
4,965 |
|
|
|
|
|
Other assets |
|
|
6 |
|
|
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
11,752 |
|
|
$ |
116 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS EQUITY |
|
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Current liabilities: |
|
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|
|
|
|
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|
Current
portion of notes payable, net unamortized discount of $89 |
|
$ |
3,560 |
|
|
$ |
|
|
Accounts payable |
|
|
1,447 |
|
|
|
95 |
|
Accrued expenses |
|
|
1,191 |
|
|
|
|
|
|
|
|
|
|
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|
Total current liabilities |
|
|
6,198 |
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|
|
95 |
|
|
|
|
|
|
|
|
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Line of credit with a related party, net of unamortized discount of $423 |
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3,577 |
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|
|
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|
Notes payable |
|
|
351 |
|
|
|
|
|
|
|
|
|
|
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Total liabilities |
|
|
10,126 |
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|
|
95 |
|
|
|
|
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|
Commitments and contingencies |
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Shareholders equity: |
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Series A Preferred stock $0.01 par value, 4,000,000 shares
authorized; 977,400 and 0 shares issued and outstanding (liquidation
value of $2,566) at June 30, 2007 and December 31, 2006, respectively |
|
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10 |
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Series C Preferred Stock $0.01 par value, 500,000 shares authorized; no
shares issued or outstanding |
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Common stock $0.01 par value, 500,000,000 shares authorized;
159,320,800 and 61,775,000 shares issued and outstanding, respectively |
|
|
1,593 |
|
|
|
618 |
|
Additional paid-in capital |
|
|
261,930 |
|
|
|
279 |
|
Deficit accumulated during development stage |
|
|
(261,907 |
) |
|
|
(876 |
) |
|
|
|
|
|
|
|
Total shareholders equity |
|
|
1,626 |
|
|
|
21 |
|
|
|
|
|
|
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|
Total liabilities and shareholders equity |
|
$ |
11,752 |
|
|
$ |
116 |
|
|
|
|
|
|
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|
The accompanying Notes to Consolidated Financial Statements are an integral part of these statements.
6
OPKO Health, Inc.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(A Development-Stage Company)
(in thousands, except per share data)
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Eight Days Ended |
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Eight Days Ended |
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Period from June |
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Three Months |
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(June 23, 2006 |
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|
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|
(June 23, 2006 |
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23, 2006 |
|
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|
Ended |
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|
inception) |
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Six Months Ended |
|
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inception) |
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(inception) to |
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June 30, |
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June 30, |
|
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June 30, |
|
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June 30, |
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June 30, |
|
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|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
|
(unaudited) |
|
|
(unaudited) |
|
|
(unaudited) |
|
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Revenue |
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$ |
|
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|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Operating expenses: |
|
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|
|
|
|
|
|
|
|
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|
|
|
|
|
|
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|
Selling, general and
administrative |
|
|
5,339 |
|
|
|
|
|
|
|
5,428 |
|
|
|
|
|
|
|
5,804 |
|
Research and development |
|
|
5,434 |
|
|
|
250 |
|
|
|
11,507 |
|
|
|
250 |
|
|
|
12,015 |
|
Write-off of acquired in-
process research and
development |
|
|
|
|
|
|
|
|
|
|
243,761 |
|
|
|
|
|
|
|
243,761 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Operating Expenses |
|
|
(10,773 |
) |
|
|
(250 |
) |
|
|
(260,696 |
) |
|
|
(250 |
) |
|
|
(261,580 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(10,773 |
) |
|
|
(250 |
) |
|
|
(260,696 |
) |
|
|
(250 |
) |
|
|
(261,580 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other expense, net |
|
|
(165 |
) |
|
|
|
|
|
|
(178 |
) |
|
|
|
|
|
|
(170 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income taxes |
|
|
(10,938 |
) |
|
|
(250 |
) |
|
|
(260,874 |
) |
|
|
(250 |
) |
|
|
(261,750 |
) |
Income taxes |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss before investment
in OTI |
|
|
(10,938 |
) |
|
|
(250 |
) |
|
|
(260,874 |
) |
|
|
(250 |
) |
|
|
(261,750 |
) |
Loss from investment in OTI |
|
|
(35 |
) |
|
|
|
|
|
|
(35 |
) |
|
|
|
|
|
|
(35 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
(10,973 |
) |
|
|
(250 |
) |
|
|
(260,909 |
) |
|
|
(250 |
) |
|
|
(261,785 |
) |
Preferred stock dividend |
|
|
(113 |
) |
|
|
|
|
|
|
(122 |
) |
|
|
|
|
|
|
(122 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable
to common shareholders |
|
$ |
(11,086 |
) |
|
$ |
(250 |
) |
|
$ |
(261,031 |
) |
|
$ |
(250 |
) |
|
$ |
(261,907 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per share, basic and
diluted |
|
$ |
(0.09 |
) |
|
$ |
(3.68 |
) |
|
$ |
(2.86 |
) |
|
$ |
(3.68 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of
shares outstanding -
basic and diluted |
|
|
117,871,000 |
|
|
|
68,000 |
|
|
|
91,399,000 |
|
|
|
68,000 |
|
|
|
|
|
The accompanying Notes to Consolidated Financial Statements are an integral part of these statements.
7
OPKO Health, Inc.
CONDENSED CONSOLIDATED STATEMENTS SHAREHOLDERS EQUITY
(A Development-Stage Company)
(in thousands except share data)
For the Cumulative period from inception (June 23, 2006) to June 30, 2007 (unaudited)
|
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|
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|
Additional |
|
|
|
|
|
|
|
|
|
Series A Preferred Stock |
|
|
Series C Preferred Stock |
|
|
Common Stock |
|
|
Paid-In- |
|
|
Accumulated |
|
|
|
|
|
|
Shares |
|
|
Dollars |
|
|
Shares |
|
|
Dollars |
|
|
Shares |
|
|
Dollars |
|
|
Capital |
|
|
Deficit |
|
|
Total |
|
Issuance of capital
stock
to founders of
Froptix |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
$ |
|
|
|
|
61,775,000 |
|
|
$ |
618 |
|
|
$ |
20 |
|
|
$ |
|
|
|
$ |
638 |
|
Stock-based
compensation expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
259 |
|
|
|
|
|
|
|
259 |
|
Net Loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(876 |
) |
|
|
(876 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December
31, 2006, adjusted to
reflect reverse
merger
on March 27, 2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
61,775,000 |
|
|
|
618 |
|
|
|
279 |
|
|
|
(876 |
) |
|
|
21 |
|
Stock based
compensation expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11,947 |
|
|
|
|
|
|
|
11,947 |
|
Issuance of common and
preferred stock and
options and warrants
for net monetary
assets |
|
|
1,081,800 |
|
|
|
11 |
|
|
|
|
|
|
|
|
|
|
|
36,606,000 |
|
|
|
366 |
|
|
|
15,626 |
|
|
|
|
|
|
|
16,003 |
|
Acquisition of Acuity
Pharmaceuticals, Inc. |
|
|
|
|
|
|
|
|
|
|
457,584 |
|
|
|
5 |
|
|
|
14,837,000 |
|
|
|
148 |
|
|
|
234,470 |
|
|
|
|
|
|
|
234,623 |
|
Issuance of common
stock upon automatic
conversion of Series
C
preferred stock |
|
|
|
|
|
|
|
|
|
|
(457,584 |
) |
|
|
(5 |
) |
|
|
45,758,400 |
|
|
|
458 |
|
|
|
(453 |
) |
|
|
|
|
|
|
|
|
Exercise of stock
options |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
79,000 |
|
|
|
1 |
|
|
|
62 |
|
|
|
|
|
|
|
63 |
|
Exercise of common
warrants |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
161,000 |
|
|
|
1 |
|
|
|
(1 |
) |
|
|
|
|
|
|
|
|
Conversion of Series A
preferred stock |
|
|
(104,400 |
) |
|
|
(1 |
) |
|
|
|
|
|
|
|
|
|
|
104,400 |
|
|
|
1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred Stock
Dividend |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(122 |
) |
|
|
(122 |
) |
Net Loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(260,909 |
) |
|
|
(260,909 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30,
2007 |
|
|
977,400 |
|
|
$ |
10 |
|
|
|
|
|
|
$ |
|
|
|
|
159,320,800 |
|
|
$ |
1,593 |
|
|
$ |
261,930 |
|
|
$ |
(261,907 |
) |
|
$ |
1,626 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying Notes to Consolidated Financial Statements are an integral part of these statements.
8
OPKO Health, Inc.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(A Development-Stage Company)
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eight Days Ended |
|
|
Period from June |
|
|
|
|
|
|
|
(June 23, 2006 |
|
|
23, 2006 |
|
|
|
Six Months Ended |
|
|
inception) |
|
|
(inception) to |
|
|
|
June 30, |
|
|
June 30, |
|
|
June 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
|
(unaudited) |
|
|
(unaudited) |
|
|
(unaudited) |
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(260,909 |
) |
|
$ |
(250 |
) |
|
$ |
(261,785 |
) |
Adjustments to reconcile net loss to net cash used in
operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation |
|
|
8 |
|
|
|
|
|
|
|
8 |
|
Write-off of in-process research and development |
|
|
243,761 |
|
|
|
|
|
|
|
243,761 |
|
Amortization of debt discount related to notes payable |
|
|
69 |
|
|
|
|
|
|
|
69 |
|
Loss from investment in OTI |
|
|
35 |
|
|
|
|
|
|
|
35 |
|
Stock compensation employees and vendors |
|
|
11,947 |
|
|
|
|
|
|
|
12,206 |
|
Changes in: |
|
|
|
|
|
|
|
|
|
|
|
|
Prepaid expenses and other current assets |
|
|
86 |
|
|
|
|
|
|
|
86 |
|
Other assets |
|
|
(7 |
) |
|
|
|
|
|
|
(7 |
) |
Accounts payable |
|
|
(577 |
) |
|
|
250 |
|
|
|
(483 |
) |
Accrued expenses |
|
|
(744 |
) |
|
|
|
|
|
|
(744 |
) |
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(6,331 |
) |
|
|
|
|
|
|
(6,854 |
) |
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Acquisition of Ophthalmic Technologies, Inc. |
|
|
(5,000 |
) |
|
|
|
|
|
|
(5,000 |
) |
Acquisition of a business, net of cash |
|
|
1,135 |
|
|
|
|
|
|
|
1,135 |
|
Capital expenditures |
|
|
(21 |
) |
|
|
|
|
|
|
(21 |
) |
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities |
|
|
(3,886 |
) |
|
|
|
|
|
|
(3,886 |
) |
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common and preferred stock and
options and warrants for cash |
|
|
|
|
|
|
|
|
|
|
639 |
|
Proceeds from sale of common stock, net |
|
|
16,284 |
|
|
|
|
|
|
|
16,284 |
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activity |
|
|
16,284 |
|
|
|
|
|
|
|
16,923 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net change in cash |
|
|
6,067 |
|
|
|
|
|
|
|
6,183 |
|
Cash and cash equivalents at beginning of period |
|
|
116 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
6,183 |
|
|
$ |
|
|
|
$ |
6,183 |
|
|
|
|
|
|
|
|
|
|
|
The accompanying Notes to Consolidated Financial Statements are an integral part of these statements.
9
OPKO Health, Inc.
NOTES TO FINANCIAL STATEMENTS
(A Development-Stage Company)
Note 1 Business and Organization
On June 8, 2007, we changed our name to OPKO Health, Inc., from eXegenics, Inc. Through March 26,
2007, eXegenics was a public shell company whose assets consisted of cash and nominal other assets.
On February 9, 2007, eXegenics completed the sale of 19,440,491 shares of its common stock for $8.0
million, constituting 51% of its issued and outstanding shares of capital stock on a fully diluted
basis, to a small group of investors led by The Frost Group, LLC, or the Frost Group, a related
party.
On March 27, 2007, pursuant to the terms of a Merger Agreement and Plan of Reorganization, Froptix
Corporation, or Froptix, a development stage research and development company, controlled by the
Frost Group, and Acuity Pharmaceuticals, Inc., or Acuity, a development stage research and
development company and eXegenics were part of a three-way merger. Per that agreement, eXegenics
issued new capital stock to acquire all of the issued and outstanding capital stock of Froptix and
Acuity. Froptix was incorporated on June 23, 2006.
After the merger, eXegenics began doing business as OPKO Health, Inc., or OPKO. OPKO and its
wholly-owned subsidiaries (including Froptix and Acuity) are referred to as We or the Company.
We are engaged through our wholly-owned subsidiaries, in the development of innovative therapies
for the treatment and prevention of ophthalmic disease. Our lead pharmaceutical product candidate
in clinical development is bevasiranib for the treatment of wet age-related macular degeneration
(Wet AMD). We are a Delaware corporation, headquartered in Miami, Florida with clinical
operations in Morristown, New Jersey.
Froptix was the accounting acquirer in the three-way merger. The three-way merger has been
accounted for as:
|
|
|
a reverse merger between Froptix and eXegenics (a public shell company). For accounting
purposes Froptix has been treated as the continuing registrant. As a result, all post
merger comparative historical financials statements filed by us will be those of Froptix.
Further, Froptix historical shareholders equity prior to the merger has been
retroactively restated (recapitalized) for the equivalent number of shares received in the
reverse merger. Loss per share calculations have also been retroactively restated to give
effect to the recapitalization for all periods presented. Lastly, the merger between
Froptix and eXegenics has been accounted for as a capital transaction equivalent to the
issuance of capital stock by Froptix for the net monetary assets of eXegenics. |
|
|
|
|
an asset acquisition of Acuity by Froptix. |
The Merger Agreement provided for the merger of Froptix with and into e-Acquisition Company I-A,
LLC, with e-Acquisition Company I-A, LLC surviving as our wholly-owned subsidiary (referred to as
the Froptix Merger) and the merger of Acuity with and into e-Acquisition Company II-B, LLC, with
e-Acquisition Company II-B, LLC surviving as our wholly-owned subsidiary (referred to as the
Acuity Merger and, with the Froptix Merger, the Mergers). In connection with the consummation
of the Mergers (1) e-Acquisition Company I-A, LLC changed its name to Froptix, LLC, (2)
e-Acquisition Company II-B, LLC changed its name to Acuity Pharmaceuticals, LLC and (3) OPKO
became the parent company of these two wholly-owned operating subsidiaries. At the closing of the
Mergers, the former shareholders of Froptix and Acuity received shares of our common stock and
preferred stock as well as warrants to purchase our common stock in exchange for all of their
shares of Froptix and Acuity.
As a result, at the closing of the Mergers, we issued (a) an aggregate of 61,775,000 shares of our
common stock to the former holders of Froptix common stock, (b) an aggregate of 14,837,000 shares
of our common stock to the former holders of Acuity common stock and Acuity Series A preferred
stock, and (c) an aggregate of 457,584 shares of our Series C preferred stock, convertible into
45,758,400 shares of our common stock, to the former holders of Acuity Series B preferred stock. We
also granted 21,144,128 warrants to purchase shares of our common stock to former shareholders of
Froptix and Acuity. We also granted 15,810,063 options to purchase our common stock to former
option holders of Froptix and Acuity.
10
Acuity Asset Acquisition. On March 27, 2007, the Company purchased Acuitys assets in a stock for
stock transaction. We valued our common stock issued to Acuity shareholders at the average closing
price of the common stock on the date of acquisition and the two days prior to the transaction.
The following table summarizes the estimated fair value of the net assets acquired at the date of
acquisition:
|
|
|
|
|
(in thousands) |
|
|
|
|
Current assets (including cash of $1,135) |
|
$ |
1,350 |
|
Property and equipment |
|
|
85 |
|
In-process research and development |
|
|
243,761 |
|
Accounts payable and accrued expenses |
|
|
(3,154 |
) |
Line of credit and term loan |
|
|
(7,419 |
) |
|
|
|
|
Total purchase price |
|
$ |
234,623 |
|
|
|
|
|
The portion of the purchase price allocated to in-process research and development of $243.8
million was immediately expensed. The purchase price includes $1.5 million of costs incurred by
eXegenics to acquire Acuity including $1.3 million of costs associated with the issuance of
warrants to the Frost Group. Refer to Note 4. The purchase consideration issued and the purchase
price allocation are preliminary pending completion and review of related valuation procedures. As
a result the amounts above are subject to change.
Treatment of Warrants and Options. In connection with the Mergers, we assumed the obligations under
outstanding warrants previously granted by Acuity to purchase 1,247,271 shares of Acuity common
stock and 325,000 shares of Acuity Series B preferred stock and, in connection therewith, we issued
warrants to purchase 7,214,730 shares of our common stock and warrants to purchase 16,866 shares of
Series C preferred stock to such Acuity warrant holders, convertible into 1,686,600 shares of our
common stock.
Immediately before the closing of the Mergers, Froptix had outstanding options to purchase 65
shares of Froptix common stock and Acuity had outstanding options to purchase 2,191,619 shares of
Acuity common stock and options to purchase 141,000 shares of Acuity Series B preferred stock.
Pursuant to the terms of the Merger Agreement, the Company assumed all of the outstanding
obligations under such options and, accordingly, the Company anticipates issuing 15,810,063 shares
of its common stock and 7,317 shares of its Series C preferred stock, convertible into 731,700
shares of our common stock, upon the exercise of such options in lieu of shares of common stock of
Froptix or common stock and/or preferred shares of Acuity.
The following table includes the pro forma results for the eight days ended June 30, 2006 of the
combined companies as though the Mergers had been completed as of June 23, 2006.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma |
|
|
|
|
(in
thousands, except per share amounts) |
|
As reported |
|
|
adjustments |
|
|
Pro forma |
|
Revenue |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Net loss |
|
$ |
(250 |
) |
|
$ |
(243 |
) |
|
$ |
(493 |
) |
Basic and diluted
loss per share |
|
$ |
(3.68 |
) |
|
$ |
(0.02 |
) |
|
$ |
(0.03 |
) |
The basic
and diluted loss per share in the pro forma columns assume the shares
issued to Acuity in the Mergers were issued and outstanding for the
entire period, resulting in 14,905,000 basic and diluted shares
outstanding.
The
following table includes the pro forma results for the six months
ended June 30, 2007 of the
combined companies as though the Mergers had been completed as of January 1, 2007.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma |
|
|
|
|
(in
thousands, except per share amounts) |
|
As reported |
|
|
adjustments |
|
|
Pro forma |
|
Revenue |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Net loss |
|
$ |
(260,909 |
) |
|
$ |
(6,792 |
) |
|
$ |
(267,701 |
) |
Basic and diluted
loss per share |
|
$ |
(2.86 |
) |
|
$ |
(0.07 |
) |
|
$ |
(2.72 |
) |
On January 11, 2007, the Frost Group extended a $7.0 million line of credit to Acuity. As part of
the merger transaction on March 27, 2007, the Frost Group increased its line of credit to Acuity to
$12 million and consented to the transfer of Acuitys repayment obligation to OPKO.
Note 2 Development Stage Risks and Liquidity
We have been in the development stage since inception and have not generated any revenues. We have
not achieved profitable operations and we expect to incur substantial losses in future periods.
Accordingly, the accompanying financial statements have been prepared using the accounting formats
prescribed by SFAS No. 7 Accounting and
Reporting by Development Stage Enterprises. The successful completion of our
11
development program
and our transition to commercial operations, if at all, is dependent upon obtaining necessary
regulatory approvals from the United States Food and Drug Administration (FDA) prior to selling
our products within the United States, and foreign regulatory approvals must be obtained to sell
our products internationally. There can be no assurance that our products will receive regulatory
approvals, and a substantial amount of time may pass before we achieve a level of sales adequate to
support our operations, if at all. We will also incur substantial expenditures in connection with
the development and regulatory approval process for our products and we will need to raise
significant additional capital during the developmental period. Obtaining marketing approval will
be directly dependent on our ability to implement the necessary regulatory steps required to obtain
marketing approval in the United States and other countries and the success of our clinical trials.
We cannot predict the outcome of these activities. Additionally, there is no assurance that
profitable operations, if ever achieved, could be sustained on a continuing basis. In addition,
development activities and clinical and preclinical testing and commercialization of our
proprietary technology will require significant additional financing. Our deficit accumulated
during the development stage through June 30, 2007 was $261.9 million, and we expect to
incur substantial and increasing losses in future periods.
Our future operations are dependent on the timely and successful completion of our ongoing research
and development, the development of competitive therapies by other biotechnology and pharmaceutical
companies, other treatment modalities for our targeted diseases, and ultimately, regulatory
approval and market acceptance of our proposed future products.
We anticipate that we will require additional funding before the end of 2008. We plan to finance
future operations with a combination of private placements; payments from potential strategic
research and development, licensing and/or marketing arrangements; public offerings; debt
financing; and revenues from future product sales, if any. We have not generated positive cash
flows from operations, and there are no assurances that we will be successful in obtaining an
adequate level of financing for the development and commercialization of our planned products. Our
ability to continue as a going concern is dependent upon the infusion of addition capital in the
future.
Note 3 Summary of Significant Accounting Policies
Basis of Presentation. The accompanying unaudited interim condensed consolidated financial
statements have been prepared in accordance with accounting principles generally accepted in the
United States and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly,
they do not include all information and footnotes required by accounting principles generally
accepted in the United States for complete financial statements. However, in the opinion of
management, all adjustments (consisting of only normal recurring adjustments) considered necessary
to present fairly the Companys results of operations, financial position and cash flows have been
made. The results of operations for the three and six months ended June 30, 2007 and cash flows for
the six months ended June 30, 2007, are not necessarily indicative of the results of operations and
cash flows that may be reported for the remainder of 2007 or for future periods. The interim
consolidated financial statements should be read in conjunction with the consolidated financial
statements and the Notes to Consolidated Financial Statements included in our Current Report on
Form 8-K filed as a result of the Merger on March 27, 2007. Refer to Note 1.
Use of Estimates. The preparation of financial statements in conformity with accounting principles
generally accepted in the United States of America 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 date of the financial statements and the reported amounts of revenues
and expenses during the reporting period. Actual results could differ from those estimates.
Cash and Cash Equivalents. We consider all non-restrictive, highly liquid short-term investments
purchased with an original maturity of three months or less to be cash equivalents.
Property and Equipment. Property and equipment are recorded at cost. Depreciation is provided using
the straight-line method over the estimated useful lives of the assets, generally five to ten
years. Expenditures for repairs and maintenance are charged to expense as incurred, while
betterments are capitalized.
12
Impairment of Long-Lived Assets. In accordance with Statement of Financial Accounting Standards
(SFAS) No. 144, Accounting for Impairment or Disposal of Long-Lived Assets , long-lived assets,
such as property and equipment, are reviewed for impairment whenever events or changes in
circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability
of assets to be held and used is measured by a comparison of the carrying amount of an asset to
estimated undiscounted future cash flows expected to be generated by the asset. If the carrying
amount of an asset exceeds its estimated future cash flows, then an impairment charge is recognized
by the amount by which the carrying amount of the asset exceeds the fair value of the asset. As of
June 30, 2007, we believe that no revision of the remaining useful lives or write-down of
long-lived assets is required.
Research and Development. Research and product development costs are charged to expense as
incurred. We record expense for in-process research and development as those that had not reached
technological feasibility and which had no alternative use.
Income Taxes. Income taxes are accounted for under the asset-and-liability method. Deferred tax
assets and liabilities are recognized for the future tax consequences attributable to differences
between the financial statement carrying amounts of existing assets and liabilities and the
respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and
liabilities are measured using enacted tax rates expected to apply to taxable income in the years
in which those temporary differences are expected to be recovered or settled. The effect on
deferred tax assets and liabilities of a change in tax rates is recognized in operations in the
period that includes the enactment date.
Loss Per Common Share. Basic and diluted loss per common share is based on the net loss increased
by dividends on preferred stock divided by the weighted average number of common shares outstanding
during the period. No effect has been given to outstanding options, warrants or convertible
preferred stock in the diluted computation, as their effect would be antidilutive. As of June 30,
2007, we have 159,320,800 common shares outstanding, in addition, we have options, warrants and
convertible preferred stock outstanding at June 30, 2007 that, if converted/exercised would result
in 55,120,200 incremental shares of common stock being outstanding
resulting in 214,441,000
potential common shares outstanding. The diluted loss per share does not include the weighted
average impact of these securities of 50,487,000 for the three and six months ended June 30, 2007,
respectively.
Share-Based Compensation. We follow the provisions of Financial Accounting Standards Board (FASB)
Statement of Financial Accounting Standards (Statement) No. 123 (revised 2004), Share-Based
Payment (SFAS 123R), which requires that a company measure the cost of employee services received
in exchange for an award of equity instruments based on the grant-date fair value of the award.
That cost is recognized in the statement of operations over the period during which an employee is
required to provide service in exchange for the award. SFAS 123R also requires that excess tax
benefits, as defined, realized from the exercise of stock options be reported as a financing cash
inflow rather than as a reduction of taxes paid in cash flow from operations. Refer to Note 5.
Stock-based compensation arrangements to non-employees are accounted for in accordance with SFAS
No. 123 and Emerging Issues Task Force Issue No. 96-18 (EITF 96-18), Accounting for Equity
Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling,
Goods or Services, which requires that these equity instruments are recorded at their fair value
on the measurement date. The measurement of stock-based compensation is subject to periodic
adjustment as the underlying equity instruments vest.
Comprehensive Loss. Our comprehensive loss has no components other than net loss for all periods
presented.
New accounting pronouncements: In July 2006, the Financial Accounting Standards Board, or FASB,
issued Interpretation Number, or FIN, No. 48, Accounting for Uncertainty in Income Taxes , or FIN
48. FIN 48 applies to all tax positions within the scope of SFAS No. 109, applies a more likely
than not threshold for tax benefit recognition, identifies a defined methodology for measuring
benefits and increases the disclosure requirements for companies. FIN 48 is mandatory for years
beginning after December 15, 2006; accordingly, we have adopted FIN 48 effective January 1, 2007.
Refer to Note 6.
In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements , or SFAS No. 157. SFAS
No. 157 defines fair value, establishes a framework for measuring fair value under generally
accepted accounting principles and expands disclosures about fair value measurements. This
Statement applies to other accounting pronouncements
that require or permit fair value measurements, the FASB having previously concluded in those
accounting pronouncements that fair value is the relevant measurement attribute. Accordingly, this
Statement does not require
13
any new fair value measurements. SFAS No. 157 is effective for fiscal
years beginning after December 15, 2007. We plan to adopt SFAS No. 157 beginning in the first
quarter of our 2008 fiscal year. We are currently evaluating the impact the adoption of SFAS No.
157 may have on our financial position and results of operations.
In February 2007, the FASB issued SFAS No. 159, The Fair Value Option for Financial Assets and
Financial Liabilities , or SFAS No. 159, which gives companies the option to measure eligible
financial assets, financial liabilities and firm commitments at fair value (i.e., the fair value
option), on an instrument-by-instrument basis, that are otherwise not permitted to be accounted for
at fair value under other accounting standards. The election to use the fair value option is
available when an entity first recognizes a financial asset or financial liability or upon entering
into a firm commitment. Subsequent changes in fair value must be recorded in earnings. SFAS No. 159
is effective for financial statements issued for fiscal years beginning after November 15, 2007. We
are in the process of evaluating the impact, if any, of adopting this pronouncement.
In June 2007, the Emerging Issues Task Force, or EITF, issued EITF 07-3 Accounting for Advance
Payments for Goods or Services to be Received for Use in Future Research and Development
Activities. This EITF establishes that prepayments made related to research and development goods
and services should be capitalized and recognized as expense when the goods are received or the
services have been preformed. The prepaid assets must be assessed for recoverability to ensure the
prepaid goods or services will continue to be used. EITF 07-3 is effective for new contracts
entered into in fiscal years beginning after December 15, 2007, including interim periods within
those fiscal years. We are in the process of evaluating the impact, if any, of adopting this
pronouncement.
Note 4 Debt
On January 11, 2007, Acuity entered into an agreement with the Frost Group whereby the Frost Group
provided a subordinated secured line of credit of up to $7.0 million to Acuity. The Frost Group
members include a trust controlled by Dr. Phillip Frost, who is the Companys Chief Executive
Officer and Chairman of the board of directors, Dr. Jane H. Hsiao, who is the Vice Chairman of the
board of directors and Chief Technical Officer, Steven D. Rubin who is Executive Vice President and
a director of the Company and Rao Uppaluri who is the Chief Financial Officer of the Company. In
exchange for entering into this agreement, Acuity agreed to grant to the Frost Group a warrant to
purchase up to 125,000 shares of Acuity Series B Preferred Stock, par value $0.01 per share, for an
exercise price of $2.00 per share, which upon consummation of the Merger converted into 6,478
shares of our Series C Preferred stock and a warrant to purchase up to 15,625 shares of Acuity
Common Stock, for an exercise price of $0.01 per share, which converted upon the Merger to 81,085
warrants to purchase shares of our Common Stock. On June 22, 2007, the Series C preferred stock
automatically converted to 647,800 shares of our common stock.
In connection with the consummation of the Mergers, we assumed the rights and obligations of Acuity
under this line of credit. We also amended and restated this line of credit to provide additional
available borrowing capacity. Under this amended and restated line of credit, the line of credit
was increased to $12.0 million and we assumed Acuitys existing obligation to repay $4.0 million
outstanding under the prior line of credit. We are obligated to pay interest upon maturity,
compounded quarterly on borrowings under the line of credit at a 10% annual rate, which is due on
July 11, 2009. The line of credit is collateralized by all of
our personal property, except intellectual property. In connection with the assumption and amendment of the line of credit, we granted
warrants to purchase 4,000,000 shares of our common stock to the Frost Group. The fair value of the
warrants was determined to be $12.4 million using the Black-Scholes option valuation model. Because
the issuance of the warrants and the increase in the line of credit were conditioned upon the
completion of the Mergers, the value of the warrants has been allocated on a relative fair value
basis to the cost of the Acuity acquisition ($1.3 million), the cost of the reverse merger between
Froptix and eXegenics ($11.0 million) and debt commitment fee ($0.1 million).
We assumed the rights and obligations of Acuitys $4.0 million term loan with Horizon Financial,
Inc., in connection with the Mergers. The term loan bears interest at 12.23%, which is payable
monthly commencing September 15, 2005. The principal is payable in 12 equal monthly installments
commencing August 2007. Principal on the term loan matures as follows: $1.7 million during 2007 and
$2.3 million during 2008. The term loan is collateralized by
all personal property of Acuity, except intellectual property, and contains certain negative
covenants that limit the payment of cash dividends, redemption of equity securities, changes in
ownership, and the creation or extinguishment of debt. In connection with the issuance of the term
note, Acuity issued warrants to purchase
14
200,000 shares of Series B preferred stock at $2.00 per
share, which upon the Merger converted to 10,379 shares of our Series C preferred stock and
warrants to purchase 25,000 shares of common stock at $0.01 per share, which converted to 129,736
shares of our common stock upon consummation of the Merger. On June 22, 2007, the Series C
preferred stock automatically converted to 1,037,900 shares of our common stock.
Note 5 Stock Based Compensation
As of June 30, 2007, we had three stock-based compensation plans, our 1996 Stock Option Plan, our
2000 Stock Option Plan and our 2007 Equity Incentive Plan. We also assumed the option plans of
Acuity and Froptix in the merger discussed in Note 1 (collectively the Plans). Options granted
under the 1996 Stock Option Plan, 2000 Stock Option Plan and the plans assumed from Froptix and
Acuity are exercisable for a period of up to 10 years from date of grant. The 2007 Equity
Incentive Plan is exercisable for a period up to 7 years. Vesting periods range from immediate to 4
years. The compensation expense recognized in the statements of operations for the three and six
months ended June 30, 2007 for our stock-based compensation plans was $5.9 million and $11.9
million, respectively, of which [$2.6 million and $2.7 million] was a component of general and
administrative expenses, respectively, and $3.3 million and $9.2 million was a component of
research and development expenses, respectively.
The fair value of the unvested Acuity option awards was determined at the merger date and will be
expensed over the remaining requisite service period of the options. Unvested options granted to
non-employees are marked to market each reporting period in accordance with EITF 96-18. The fair
value of stock option awards was estimated using the Black-Scholes option valuation model and the
assumptions noted in the following table:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, 2007 |
|
June 30, 2007 |
Expected life
|
|
3.23 to 9.47 years
|
|
3.48 to 9.72 years
|
Expected volatility
|
|
|
73 |
% |
|
73% to 76%
|
Risk-free interest rate
|
|
4.54% to 5.16%
|
|
4.48% to 5.16%
|
Dividend yield
|
|
|
0 |
% |
|
|
0 |
% |
The expected life of the stock options was calculated using the shortcut method allowed by the
provisions of SFAS No. 123R and interpreted by Staff Accounting Bulletin No. 107 (SAB 107). The
expected volatility was based on a peer group of publicly-traded stock which we believe will be
representative of the volatility over the expected term of the options. The risk-free interest rate
is based on the rates paid on securities issued by the U.S. Treasury with a term approximating the
expected life of the option. The dividend yield is based on the projected annual dividend payment
per share, divided by the stock price at the date of grant; however, we have not, and do not expect
to declare such dividends.
15
A summary of the stock option activity under our Plans during the six months ended June 30, 2007 is
presented below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise price per |
|
|
Weighted average |
|
|
|
Shares |
|
|
share |
|
|
exercise price |
|
Outstanding at December 31, 2006 |
|
|
4,436,878 |
|
|
$ |
0.01 |
|
|
$ |
0.01 |
|
Assumed from eXegenics at merger |
|
|
240,000 |
|
|
|
0.32 0.89 |
|
|
|
0.64 |
|
Assumed from Acuity at merger |
|
|
11,373,253 |
|
|
|
0.04 0.56 |
|
|
|
0.14 |
|
Cancelled/Forfeited |
|
|
(20,109 |
) |
|
|
0.05 0.06 |
|
|
|
0.05 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at March 31, 2007 |
|
|
16,030,022 |
|
|
|
0.01 0.89 |
|
|
|
0.11 |
|
Granted |
|
|
3,845,000 |
|
|
|
3.54 4.88 |
|
|
|
4.81 |
|
Exercised |
|
|
(79,215 |
) |
|
|
0.05 0.84 |
|
|
|
0.80 |
|
Canceled/Forfeited |
|
|
(555,110 |
) |
|
|
0.04 0.06 |
|
|
|
0.05 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at June 30, 2007 |
|
|
19,240,697 |
|
|
$ |
0.01 $4.88 |
|
|
$ |
1.04 |
|
|
|
|
|
|
|
|
|
|
|
|
|
As of June 30, 2007 there was approximately $25.8 million of total unrecognized compensation cost
related to unvested stock options, which is expected to be recognized over a remaining
weighted-average vesting period of 3.3 years. As of June 30, 2007, approximately 8.9 million
options to purchase our common stock were exercisable. In addition, at June 30, 2007, 15.6 million
outstanding options were in the money with an aggregate intrinsic value of approximately $61.8
million.
In addition to the common stock options there were 7,317 options to purchase Series C preferred
stock at an exercise price of $32.00 issued as replacement options to an Acuity employee at the
merger, which, upon conversion of the Series C Preferred stock on June 22, 2007 converted to
731,700 options to purchase our common stock. The common stock options were 100% vested and exercisable as of
June 30, 2007. The intrinsic value of the options on June 30, 2007 was $2.4 million.
On May 11, 2007, we entered into a Settlement Agreement with our former President. Under the terms
of the Settlement Agreement, our former President will receive a severance payment equivalent to
one years salary of $325,000, paid monthly, and reimbursement of up to $65,000 in relocation
expenses. In addition, all outstanding equity awards which would have vested by May 31, 2008, were
automatically vested. As a result of this acceleration, during the second quarter of 2007 we
recorded $1.5 million of additional compensation expense that would have been recognized over the
period from June 1, 2007 through May 31, 2008.
In July 2007, we terminated a consulting agreement prior to the vesting of approximately 4.4
million options to purchase our common stock. As a result, during the third quarter of 2007, we
will reverse compensation expense which was accrued during the previous 12 months of approximately
$8.1 million.
Note 6 Income Taxes
Prior to January 1, 2007, we recognized income taxes with respect to uncertain tax positions based
upon SFAS No. 5, Accounting for Contingencies , or SFAS No. 5. Under SFAS No. 5, we would record
a liability associated with an uncertain tax position if the liability was both probable and
estimable. Prior to January 1, 2007, the liabilities recorded under SFAS No. 5 including interest
and penalties related to income tax exposures, would have been recognized as incurred within
income taxes in our condensed consolidated statements of operations. We recorded no such
liabilities in 2006.
Effective January 1, 2007, we adopted FIN 48, Accounting for Uncertainty in Income Taxes . FIN
48 clarifies the accounting for uncertainty in income taxes recognized in financial statements in
accordance with SFAS No. 109, Accounting for Income Taxes . FIN 48 prescribes a recognition
threshold and measurement attribute for the
16
financial statement recognition and measurement of a
tax position taken or expected to be taken in a tax return. FIN
48 requires that we determine whether the benefit of our tax positions are more likely than not to
be sustained upon audit, based on the technical merits of the tax position. For tax positions that
are more likely than not to be sustained upon audit, we recognize the greatest amount of the
benefit that is more likely than not to be sustained in our condensed consolidated financial
statements. For tax positions that are not more likely than not to be sustained upon audit, we do
not recognize any portion of the benefit in our condensed consolidated financial statements. The
provisions of FIN 48 also provide guidance on derecognition, classification, interest and
penalties, accounting in interim periods, and disclosure.
Our policy for interest and penalties under FIN 48, related to income tax exposures, was not
impacted as a result of the adoption of the recognition and measurement provisions of FIN 48.
Therefore, we continue to recognize interest and penalties as incurred within income taxes in
our condensed consolidated statements of operations, when applicable.
There was no change to our accumulated deficit as of January 1, 2007 as a result of the adoption of
the recognition and measurement provisions of FIN 48.
Uncertain Income Tax Positions
We file income tax returns in the U.S. federal jurisdiction and with various states. We are subject
to tax audits in all jurisdictions for which we file tax returns. Tax audits by their very nature
are often complex and can require several years to complete. There are currently no tax audits that
have commenced with respect to income returns in any jurisdiction.
Federal: Under the tax statute of limitations applicable to the Internal Revenue Code, we are no
longer subject to U.S. federal income tax examinations by the Internal Revenue Service for years
before 2003. However, because we are carrying forward income tax attributes, such as net operating
losses and tax credits from 2002 and earlier tax years, these attributes can still be audited when
utilized on returns filed in the future.
State: Under the statutes of limitation applicable to most state income tax laws, we are no longer
subject to state income tax examinations by tax authorities for years before 2003 in states in
which we have filed income tax returns. Certain states may take the position that we are subject to
income tax in such states even though we have not filed income tax returns in such states and,
depending on the varying state income tax statutes and administrative practices, the statute of
limitations in such states may extend to years before 2003.
As a result of our January 1, 2007 implementation of FIN 48, the total amount of gross tax
benefits, excluding the offsetting full valuation allowance, that became unrecognized, was $0.
There were no accrued interest and penalties resulting from such unrecognized tax benefits. As of
June 30, 2007, the total amount of gross unrecognized tax benefits was $0, and accrued interest and
penalties on such unrecognized tax benefits was $0.
The net unrecognized tax benefits that, if recognized, would impact the effective tax rate as of
June 30, 2007 and December 31, 2006, were $0 and $0, respectively.
We do not anticipate that any significant increase or decrease to the gross unrecognized tax
benefits will be recorded during the remainder of 2007.
Other Income Tax Disclosures
Consistent with 2006, we anticipate recording a full valuation allowance against all of our
deferred tax assets during 2007. As a result of this valuation allowance, we expect our full year
effective tax rate to be at or about zero.
Under Section 382 of the Internal Revenue Code, certain significant changes in ownership may
restrict the future utilization of our tax loss carryforwards. The annual limitation is equal to
the value of our stock immediately before the ownership change, multiplied by the long-term
tax-exempt rate (i.e., the highest of the adjusted federal long-term rates in effect for any month
in the three-calendar-month period ending with the calendar month in which the change
17
date occurs). We are undergoing a study to determine whether we or any of our predecessors have
undergone an ownership change under Section 382. It is possible that such a study could conclude
that some or all of our net operating loss and credit carryforwards will be limited to utilization.
Because we currently have recorded full valuation allowances against such tax attributes, we do not
expect the results of such a study to have a material impact on our financial statements.
Note 7 Supplemental Cash Flow Information
Supplemental cash flow information is summarized as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from |
|
|
|
|
|
|
|
June 23, 2006 |
|
|
|
Six Months Ended |
|
|
(inception) to |
|
|
|
June 30, |
|
|
June 30, |
|
(in thousands) |
|
2007 |
|
|
2007 |
|
Interest paid |
|
$ |
163 |
|
|
$ |
163 |
|
Note 8 Related Party Transactions
In June 2007, we paid the $125,000 filing fee payable to the Federal Trade Commission in connection
with filings to be made by us and Dr. Frost, our Chairman and Chief Executive Officer, under the
Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR). The filings would permit Dr. Frost
and his affiliates to acquire additional voting securities upon expiration of the HSR waiting
period. On July 12, 2007, that waiting period expired.
On a month-to-month basis we are leasing office space from Frost Real Estate Holdings, LLC, an
entity affiliated with Dr. Phillip Frost, our Chairman, Chief Executive Officer and a principal
shareholder. We are negotiating a long-term lease for this space and expect to execute a long-term
lease during 2007. The lease is for approximately 5,000 square feet of space in an office building
in Miami, Florida, where our principal executive offices are located. The lease provides for
payments of approximately $15,000 per month while we negotiate the long-term lease, plus applicable
sales tax. The rent is inclusive of operating expenses, property taxes and parking.
As part of the Mergers, we assumed a line of credit with the Frost Group from Acuity. Refer to
Note 4.
Note 9 Description of Equity Securities
Our authorized capital stock consists of 500,000,000 shares of common stock, par value $.01 per
share, and 10,000,000 shares of preferred stock, par value $.01 per share.
Common Stock
Of the
authorized common stock, 161,020,191 shares were outstanding as of
August 6, 2007 and are held by
approximately 399 record holders. Subject to the prior rights of the holders of any shares of
preferred stock currently outstanding or which may be issued in the future, the holders of the
common stock are entitled to receive dividends from our funds legally available therefore when, as
and if declared by our board of directors, and are entitled to share ratably in all of our assets
available for distribution to holders of common stock upon the liquidation, dissolution or
winding-up of our affairs subject to the liquidation preference, if any, of any then outstanding
shares of preferred stock. Holders of our common stock do not have any preemptive, subscription,
redemption or conversion rights. Holders of our common stock are entitled to one vote per share on
all matters which they are entitled to vote upon at meetings of stockholders or upon actions taken
by written consent pursuant to Delaware corporate law. The holders of our common stock do not have
cumulative voting rights, which means that the holders of a plurality of the outstanding shares can
elect all of our directors. All of the shares of our common stock currently issued and outstanding
are fully-paid and nonassessable. No dividends have been paid to holders of our common stock since
our incorporation, and no cash dividends are anticipated to be declared or paid in the reasonably
foreseeable future.
18
Preferred Stock
Our board of directors has the authority, without further action by the holders of the outstanding
common stock, to issue preferred stock from time to time in one or more classes or series, to fix
the number of shares constituting any class or series and the stated value thereof, if different
from the par value, as to fix the terms of any such series or class, including dividend rights,
dividend rates, conversion or exchange rights, voting rights, rights and terms of redemption
(including sinking fund provisions), the redemption price and the liquidation preference of such
class or series. We presently have one series of preferred stock outstanding, designated as Series
A convertible preferred stock (the Series A preferred stock). We have no present plans to issue
any other series or class of preferred stock. The designations, rights and preferences of the
Series A preferred stock are set forth in the certificate of designations of Series A convertible
preferred stock, which has been filed with the Secretary of State of the State of Delaware.
Series A Preferred Stock
Of the authorized preferred stock, 4,000,000 shares have been designated Series A preferred stock,
977,400 of which are currently issued and outstanding and held by 66 stockholders. Dividends are
payable on the Series A preferred stock in the amount of $.25 per share, payable annually in
arrears. At the option of our board of directors, dividends will be paid either (i) wholly or
partially in cash or (ii) in newly issued shares of Series A preferred stock valued at $2.50 per
share to the extent cash dividend is not paid.
Holders of Series A preferred stock have the right to convert their shares, at their option
exercisable at any time, into shares of our common stock on a one-for-one basis subject to
anti-dilution adjustments. These anti-dilution adjustments are triggered in the event of any
subdivision or combination of our outstanding common stock, any payment by us of a stock dividend
to holders of our common stock or other occurrences specified in the certificate of designations
relating to the Series A preferred stock. We may elect to convert the Series A preferred stock into
common stock or a substantially equivalent preferred stock in the case of a merger or consolidation
in which we do not survive, a sale of all or substantially all of our assets or a substantial
reorganization of us.
Each share of Series A preferred stock is entitled to one vote on all matters on which the common
stock has the right to vote. Holders of Series A preferred stock are also entitled to vote as a
separate class on any proposed adverse change in the rights, preferences or privileges of the
Series A preferred stock and any increase in the number of authorized shares of Series A preferred
stock. In the event of any liquidation or winding up of the Company, the holders of the Series A
preferred stock will be entitled to receive $2.50 per share plus any accrued and unpaid dividends
before any distribution to the holders of the common stock and any other class of series of
preferred stock ranking junior to it.
We may redeem the outstanding shares of Series A preferred stock for $2.50 per share (plus accrued
and unpaid dividends), at any time.
Series C Preferred Stock
Of the authorized preferred stock, 500,000 shares were designated Series C preferred stock. On
June 22, 2007, 457,584 Series C preferred stock were issued and outstanding and held by 30
stockholders. Cumulative dividends were payable on the Series C preferred stock in the amount of
$1.54 per share when declared by the board of directors. On June 22, 2007, all of the shares of
Series C preferred stock automatically converted into shares of common stock, on a
one-hundred-for-one basis (subject to adjustment as noted above), as our common stock traded above
the $3.83 conversion per share price on the American Stock Exchange for ten consecutive days.
19
Anti-Takeover Effects of Certain Provisions of our Certificate of Incorporation, our By-Laws and
Delaware Law
Delaware Statute.
We are subject to Section 203 of the Delaware General Corporation law, which prohibits a publicly
held Delaware corporation from engaging in a business combination with an interested
stockholder for a period of three years after the date of the transaction in which the person
became an interested stockholder, unless:
|
|
|
prior to such date, our board of directors approves either the business combination or
the transaction that resulted in the stockholders becoming an interested stockholder; |
|
|
|
|
upon consummation of the transaction that resulted in the stockholder becoming an
interested stockholder, the interested stockholder owns at least 85% of our outstanding
voting stock, excluding shares held by directors, officers and certain employee stock
plans; or |
|
|
|
|
on or after the consummation date, the business combination is approved by our board of
directors and by the affirmative vote at an annual or special meeting of stockholders
holding of at least two-thirds of our outstanding voting stock that is not owned by the
interested stockholder. |
For purposes of Section 203, a business combination includes, among other things, a merger, asset
sale or other transaction resulting in a financial benefit to the interested stockholder, and an
interested stockholder is generally a person who, together with affiliates and associates of such
person:
|
|
|
owns 15% or more of outstanding voting stock; or |
|
|
|
|
is an affiliate or associate of ours and was the owner of 15% or more of our outstanding
voting stock at any time within the prior three years. |
Certificate of Incorporation and Bylaw Provisions.
Our amended and restated certificate of incorporation and amended and restated bylaws include
provisions that, among others, could have the effect of delaying, deferring, or discouraging
potential acquisition proposals and could delay or prevent a change of control of us. The
provisions in our certificate of incorporation and bylaws that may have such effect include:
|
|
|
Preferred Stock. As noted above, our board of directors, without stockholder approval,
has the authority under our certificate of incorporation to issue preferred stock with
rights superior to the rights of the holders of common stock. As a result, we could issue
preferred stock quickly and easily, which could adversely affect the rights of holders of
our common stock and could be issued with terms calculated to delay or prevent a change of
control or make removal of management more difficult. |
|
|
|
|
Election and Removal of Directors. Directors may be removed by the affirmative vote of
the holders of at least a majority of the voting power of all of the outstanding shares of
capital stock of the corporation entitled to vote thereon, voting together as a single
class. |
|
|
|
|
Stockholder Meetings. Under our certificate of incorporation and bylaws, special
meetings of our stockholders may be called only by the vote of a majority of the entire
board. Our stockholders may not call a special meeting of the stockholders. |
|
|
|
|
Requirements for Advance Notification of Stockholder Nominations and Proposals. Our
bylaws establish advance notice procedures with respect to stockholder proposals and the
nomination of candidates for election as directors, other than nominations made by or at
the direction of our board of directors or a committee thereof. |
20
Note 10 Acquisition
On April 13, 2007, pursuant to a definitive Share Purchase Agreement (the Purchase Agreement)
with OTI and its shareholders, we invested $5.0 million in Ophthalmic Technologies, Inc., or OTI,
an Ontario corporation. In exchange for the $5.0 million investment, OTI issued common shares of
OTI to us to cause us to hold one-third of OTIs share capital on a fully diluted basis and we
received an exclusive option to purchase the remaining shares of OTI in exchange for the issuance
of between 3.13 million and 2.82 million shares of our common stock, depending upon the average per
share closing price of our common stock for the ten (10) trading dates ended on the second business
day prior to the exercise of the option. The $5.0 million will be used by OTI for working capital.
The aforesaid option shall extend for the greater of a period of (i) six (6) months from the date
of the agreement and (ii) three (3) months from completion of OTIs fiscal years ended April 30,
2006 and April 30, 2007 financial statement audits.
We have accounted for the investment in OTI under Accounting Principles Board Opinion 18, under the
equity method of accounting. The initial $5 million investment was allocated between the
investment in OTI and the option to purchase OTI. The option was valued based on the estimated
exercise price of the option and the estimated market value of the outstanding shares of OTI. The
investment was accounted for as the gross investment less the loss incurred by OTI during the
period in which we held the interest in them. The table below reconciles the investment in OTI:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase (decrease) |
|
|
|
|
|
|
|
|
|
|
during the |
|
|
Balance at June 30, |
|
(in thousands) |
|
Initial investment |
|
|
investment period |
|
|
2007 |
|
Option to purchase remaining shares of OTI |
|
$ |
618 |
|
|
$ |
|
|
|
$ |
618 |
|
Investment in OTI |
|
|
4,382 |
|
|
|
(35 |
) |
|
|
4,347 |
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
5,000 |
|
|
$ |
(35 |
) |
|
$ |
4,965 |
|
21
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
OVERVIEW
You should read this discussion together with the Financial Statements, related Notes and other
financial information included elsewhere in our Current Report on Form 8-K dated March 27, 2007
(the Form 8-K). The following discussion contains assumptions, estimates and other
forward-looking statements that involve a number of risks and uncertainties, including those
discussed under Risk Factors, in the Form 8-K . These risks could cause our actual results to
differ materially from those anticipated in these forward-looking statements.
We are a development stage company that has generated significant losses since our inception in
June 2006. We expect to incur substantial losses as we plan to continue the development of our
product candidates, particularly bevasiranib, continue our other research and development
activities and establish a sales and marketing infrastructure in anticipation of the
commercialization of our product candidates. We currently have limited commercialization
capabilities, however we plan to build our commercialization infrastructure as we prepare to launch
our development products, and it is possible that we may never successfully commercialize any of
our product candidates. To date, we have devoted substantially all of our efforts towards research
and development of our product candidates. As of June 30, 2007, we had an accumulated deficit of
$261.9 million. Since we do not generate revenue from any of our product candidates, we expect to
continue to generate losses in connection with the continued clinical development of bevasiranib
and the research and development activities relating to our technology and other drug candidates.
Such research and development activities are budgeted to expand over time and will require further
resources if we are to be successful. As a result, we believe that our operating losses are likely
to be substantial over the next several years. We will need to obtain additional funds to further
develop our research and development programs.
On June 8, 2007, we changed our name to OPKO Health, Inc., or OPKO, from eXegenics, Inc., or
eXegenics. On March 27, 2007, we were part of a three-way merger between Froptix Corporation, or
Froptix, a research and development company, eXegenics, a shell public company, and Acuity
Pharmaceuticals, Inc., or Acuity, a research and development company. This transaction was
accounted for as a reverse merger between Froptix and eXegenics, with the combined company then
acquiring Acuity. eXegenics, Inc., formerly known as Cytoclonal Pharmaceuticals Inc., was
previously involved in the research, creation, and development of drugs for the treatment and/or
prevention of cancer and infectious diseases. Previously, eXegenics operated as a drug discovery
company, exploiting new enabling technologies to advance and shorten the new drug development
cycle. However, eXegenics had been a public shell company without any operations since 2003.
On April 13, 2007, we invested $5.0 million in Ophthalmic Technologies, Inc., or OTI, an Ontario
corporation pursuant to a definitive Share Purchase Agreement (the Purchase Agreement) with OTI
and its shareholders. In exchange for the $5.0 million investment, OTI issued common shares of OTI
to us to cause us to hold one-third OTIs share capital on a fully diluted basis and we received an
exclusive option to purchase the remaining shares of OTI in exchange for the issuance of between
3.13 million and 2.82 million shares of our common stock, depending upon the average per share
closing price of our common stock for the ten (10) trading dates ended on the second business day
prior to the exercise of the option. The $5.0 million will be used by OTI for working capital.
RESULTS OF OPERATIONS
FOR THE THREE MONTHS ENDED JUNE 30, 2007 AND 2006
The results of operations for the three months ended June 30, 2007 include the operating results
for the full three month period. The results for the period ended June 30, 2006 only include
Froptixs result from its inception on June 23, 2006 through June 30, 2006. As a result of the
reverse merger, historical comparative results are those of Froptix only.
Selling, General and Administrative Expense. General and administrative expense for the three
months ended June 30, 2007 was $5.3 million compared to no expenses for the comparable period of
2006. General and administrative expense primarily included personnel costs, including stock-based
compensation and professional fees. During 2007,
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we anticipate general and administrative expense to increase to reflect the costs of being an
operating public company. We incurred costs related to building a commercial infrastructure during
the three months ended June 30, 2007 in preparation of the acquisition of OTI. We were formed on
June 23, 2006 and as a result, did not incur significant expenses during the comparable period of
2006.
Research and Development Expense. Research and development expense for the three months ended June
30, 2007 was $5.4 million compared to no expense for the comparable period of 2006. Research and
development expense primarily related to personnel costs, including stock-based compensation as
well as costs related to the initiation in July 2007 of the Phase III clinical trial for
bevasiranib. For the comparable period of 2006, we incurred $250,000 of expenses relating to the
execution of a research agreement.
Other Income and Expenses. Other expense was $0.2 million, net of $0.1 million of interest income.
Other income primarily consists of interest earned on our cash and cash equivalents and interest
expense reflects the interest incurred on the debt we assumed from Acuity as part of the merger.
FOR THE SIX MONTHS ENDED JUNE 30, 2007 AND FROM JUNE 23, 2006 (INCEPTION) THROUGH JUNE 30, 2006
The results of operations for the first six months of 2007 include Froptix operating results for
the full six month period, and Acuitys operating results subsequent to March 27, 2007. As a result
of the reverse merger, historical comparative results are those of Froptix only. Froptix was
incorporated on June 23, 2006 and as a result, did not have significant operations for most of the
first six months of 2006.
Selling, General and Administrative Expense. General and administrative expense for the first six
months of 2007 was $5.4 million. General and administrative expense primarily included personnel
costs, including stock-based compensation and professional fees. During 2007, we anticipate general
and administrative expense to increase to reflect the costs of being an operating public company.
We incurred costs related to building a commercial infrastructure during the thee months ended June
30, 2007 in preparation of the acquisition of OTI.
Research and Development Expense. Research and development expense for the first six months of 2007
was $11.5 million. Research and development expense primarily related to personnel costs, including
stock-based compensation as well as costs related to the initiation of the Phase III clinical trial
for bevasiranib.
Research and development expense during 2007 will primarily relate to our bevasiranib program
including costs to prepare for our Phase III clinical study for bevasiranib. We initiated
enrollment of our Phase III clinical trial for bevasiranib in July 2007. We expect the total cost
of this trial to be approximately $25 million, although this estimate could vary significantly as
the Phase III clinical trial progresses.
Write-off of Acquired In-Process Research and Development. On March 27, 2007, we acquired Acuity in
a stock for stock transaction. We valued our common stock issued to Acuity shareholders at the
average closing price of the common stock on the date of the transaction and two days prior to the
transaction. We recorded the assets and liabilities at fair value, and as a result, we recorded
acquired in-process research and development expense and recorded a charge of $243.8 million.
Other Income and Expenses. Other expense was $0.2 million, net of $0.1 million of interest income.
Other income primarily consists of interest earned on our cash and cash equivalents and interest
expense reflects the interest incurred during the period from March 27, 2007 through March 31, 2007
on the debt we assumed from Acuity as part of the Mergers.
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LIQUIDITY AND CAPITAL RESOURCES
At June 30, 2007, we had cash and cash equivalents of approximately $6.2 million. Cash used in
operations primarily related to payments of liabilities assumed and or incurred as part of the
Mergers. Since our inception, we have not generated revenue and our primary source of cash has been
from the private placement of stock and through credit facilities available to us.
On April 13, 2007, we invested $5.0 million in Ophthalmic Technologies, Inc., or OTI, an Ontario
corporation pursuant to a definitive Share Purchase Agreement (the Purchase Agreement) with OTI
and its shareholders. In exchange for the $5.0 million investment, OTI issued common shares of OTI
to us to cause us to hold one-third of the equity in OTI on a fully diluted basis. The $5.0 million
will be used by OTI for working capital. In addition to the one-third interest, we also received
an exclusive right to purchase the remaining outstanding shares of OTI for $10 million, payable by
issuance of our common stock subject to a collar limiting the number of shares to be issued to be
between 2.8 and 3.1 million shares of our common stock.
We assumed the rights and obligations of Acuitys $4.0 million term loan with Horizon Financial,
Inc., in connection with the Mergers. The term loan bears interest at 12.23%, which is payable
monthly commencing September 15, 2005. The principal is payable in 12 equal monthly installments
commencing August 2007. Principal on the term loan matures as follows: $1.7 million during 2007 and
$2.3 million during 2008. The term loan is collateralized by all personal property of the Acuity,
except intellectual property, and contains certain negative covenants that limit the payment of
cash dividends, redemption of equity securities, change in ownership, and the creation or
extinguishment of debt. In connection with the issuance of the term note, Acuity issued warrants to
purchase 200,000 shares of Series B at $2.00 per share which converted to 1,037,900 shares and 235,932 shares,
respectively; of our common stock upon consummation of the Mergers in
addition to warrants to purchase 25,000 shares of
common stock at $0.01 per share, which converted to 129,736 warrants
to purchase our common stock upon consummation of the Mergers.
In connection with the consummation of the Mergers, we assumed the rights and obligations of Acuity
under the line of credit Acuity had with the Frost Group. We also amended and restated the Frost
Group line of credit to provide additional available borrowing capacity. Under this amended and
restated line of credit, we gained access to $8.0 million in available borrowings and we assumed
Acuitys existing obligation to repay $4.0 million outstanding under the line of credit. We are
obligated to pay interest upon maturity, capitalized quarterly on outstanding borrowings under the
line of credit at a 10% annual rate. In connection with the assumption and amendment of the line of
credit, we granted warrants to purchase 4,000,000 shares of our common stock to the Frost Group.
The fair value of the warrants was determined to be $12.4 million using the Black-Scholes option
valuation model. Because the issuance of the warrants and the increase in the line of credit were
conditioned upon the completion of the Mergers, the value of the warrants has been allocated on a
relative fair value basis to the cost of the Acuity acquisition ($1.3 million), the cost of the
reverse merger between Froptix and OPKO ($11.0 million) and debt commitment fee ($0.1 million).
We expect to incur losses from operations for the foreseeable future. We expect to incur increasing
research and development expenses, including expenses related to the hiring of personnel and
additional clinical trials. We expect that general and administrative expenses will also increase
as we expand our finance and administrative staff, add infrastructure, and incur additional costs
related to being a public company, including the costs of directors and officers insurance,
investor relations programs, and increased professional fees.
We believe cash and cash equivalents on hand and our available credit line at June 30, 2007 will be
sufficient to meet our anticipated cash requirements for operations and debt service for at least
the next 12 months.
We will need to finance our future cash needs through public or private equity offerings, debt
financings, or corporate collaboration and licensing arrangements. We currently do not have any
commitments for future external funding.
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CRITICAL ACCOUNTING POLICIES
We believe the following critical accounting policies affect managements more significant
judgments and estimates used in the preparation of our financial statements.
Impairment of Long-Lived Assets. In accordance with Statement of Financial Accounting Standards
(SFAS) No. 144, Accounting for Impairment or Disposal of Long-Lived Assets , long-lived assets,
such as property and equipment, are reviewed for impairment whenever events or changes in
circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability
of assets to be held and used is measured by a comparison of the carrying amount of an asset to
estimated undiscounted future cash flows expected to be generated by the asset. If the carrying
amount of an asset exceeds its estimated future cash flows, then an impairment charge is recognized
by the amount by which the carrying amount of the asset exceeds the fair value of the asset. As of
June 30, 2007, management believes that no revision of the remaining useful lives or write-down of
long-lived assets is required.
Stock-Based Compensation. As of June 23, 2006 (the date of inception) we, adopted SFAS No. 123(R),
Share-Based Payments SFAS No. 123(R) replaces SFAS No. 123, Accounting for Stock-Based Compensation, and supersedes APB No. 25. SFAS No. 123(R) requires that all stock-based compensation be
recognized as an expense in the financial statements and that such cost be measured at the fair
value of the award. We adopted the modified prospective transition method provided for under SFAS
No. 123(R). Under this transition method, compensation cost recognized in 2006 associated with
stock options includes (i) amortization related to all stock option awards granted/modified on or
subsequent to January 1, 2006, based on the estimated grant date fair value using the Black-Scholes
option-pricing model, and (ii) amortization of the intrinsic value recorded as deferred
compensation for options granted prior to January 1, 2006 being accounted for under APB Opinion No.
25. Option awards granted prior to adoption of SFAS No. 123(R) continue to follow the provisions of
APB Opinion No. 25 and FIN 44 until modified and or settled.
Prior to the adoption of SFAS No. 123(R), we presented all tax benefits resulting from the exercise
of stock options as operating cash flows in the statements of cash flows. SFAS No. 123(R) requires
that cash flows resulting from tax deductions in excess of the cumulative compensation cost
recognized for options exercised (excess tax benefits) be classified as financing cash flows. We
have sufficient net operating loss carryforwards to generally eliminate cash payments for income
taxes. Therefore, no cash has been retained as a result of excess tax benefits relating to share
based payments made to directors and employees.
NEW ACCOUNTING PRONOUNCEMENTS
In July 2006, the Financial Accounting Standards Board, or FASB, issued Interpretation Number, or
FIN, No. 48, Accounting for Uncertainty in Income Taxes , or FIN 48. FIN 48 applies to all tax
positions within the scope of SFAS No. 109, applies a more likely than not threshold for tax
benefit recognition, identifies a defined methodology for measuring benefits and increases the
disclosure requirements for companies. FIN 48 is mandatory for years beginning after December 15,
2006; accordingly, we have adopted FIN 48 effective January 1, 2007. Refer to Note 6.
In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements , or SFAS No. 157. SFAS
No. 157 defines fair value, establishes a framework for measuring fair value under generally
accepted accounting principles and expands disclosures about fair value measurements. This
Statement applies to other accounting pronouncements that require or permit fair value
measurements, the FASB having previously concluded in those accounting pronouncements that fair
value is the relevant measurement attribute. Accordingly, this Statement does not require any new
fair value measurements. SFAS No. 157 is effective for fiscal years beginning after December 15,
2007. We plan to adopt SFAS No. 157 beginning in the first quarter of our 2008 fiscal year. We are
currently evaluating the impact the adoption of SFAS No. 157 may have on our financial position and
results of operations.
In February 2007, the FASB issued SFAS No. 159, The Fair Value Option for Financial Assets and
Financial Liabilities , or SFAS No. 159, which gives companies the option to measure eligible
financial assets, financial
liabilities and firm commitments at fair value (i.e., the fair value option), on an
instrument-by-instrument basis, that
25
are otherwise not permitted to be accounted for at fair value
under other accounting standards. The election to use the fair value option is available when an
entity first recognizes a financial asset or financial liability or upon entering into a firm
commitment. Subsequent changes in fair value must be recorded in earnings. SFAS No. 159 is
effective for financial statements issued for fiscal years beginning after November 15, 2007. We
are in the process of evaluating the impacts, if any, of adopting this pronouncement.
In June 2007, the Emerging Issues Task Force, or EITF, issued EITF 07-3 Accounting for Advance
Payments for Goods or Services to be Received for Use in Future Research and Development
Activities. This EITF establishes that prepayments made related to research and development goods
and services should be capitalized and recognized as expense when the goods are received or the
services have been preformed. The prepaid assets must be assessed for recoverability to ensure the
prepaid goods or services will continue to be used. EITF 07-3 is effective for new contracts
entered into in fiscal years beginning after December 15, 2007, including interim periods within
those fiscal years. We are in the process of evaluating the impact, if any, of adopting this
pronouncement.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
In the normal course of doing business we are exposed to the risks associated with foreign currency
exchange rates and changes in interest rates. We do not engage in trading market risk sensitive
instruments or purchasing hedging instruments or other than trading instruments that are likely
to expose us to significant market risk, whether interest rate, foreign currency exchange,
commodity price or equity price risk.
Our exposure to market risk relates to our cash and investments and to our borrowings. We maintain
an investment portfolio of money market funds and qualified purchaser funds. The securities in our
investment portfolio are not leveraged, and are, due to their very short-term nature, subject to
minimal interest rate risk. We currently do not hedge interest rate exposure. Because of the
short-term maturities of our investments, we do not believe that a change in market interest rates
would have a significant negative impact on the value of our investment portfolio.
The primary objective of our investment activities is to preserve principal while at the same time
maximizing yields without significantly increasing risk. To achieve this objective, we invest our
excess cash in debt instruments of the U.S. Government and its agencies, bank obligations,
repurchase agreements and high-quality corporate issuers, and, by policy, restrict our exposure to
any single corporate issuer by imposing concentration limits. To minimize the exposure due to
adverse shifts in interest rates, we maintain investments at an average maturity of generally less
than one month.
Item 4.
Controls and Procedures
An evaluation was carried out under the supervision and with the participation of the Companys
Chief Executive Officer and Chief Financial Officer, of the effectiveness of the Companys
Disclosure Controls and Procedures as of June 30, 2007. They have concluded as of June 30, 2007,
that our Disclosure Controls and Procedures were effective at providing reasonable assurance that
information required to be disclosed by the Company in the reports that it files or submits under
the Securities Exchange Act of 1934 are recorded, processed, summarized and reported, within the
time periods specified in the Securities and Exchange Commissions rules and forms. Disclosure
Controls and Procedures include, without limitation, controls and procedures designed to ensure
that information required to be disclosed by the Company in such reports is accumulated and
communicated to the Companys management, as appropriate to allow timely decisions regarding
required disclosure.
During the quarter ended June 30, 2007, we began performing the finance functions of our
wholly-owned subsidiaries, Froptix Corporation and Acuity Pharmaceuticals, Inc., in-house. These
functions were previously outsourced. Based on the evaluation of the Companys disclosure controls
and procedures as of June 30, 2007, we are not aware of any material adverse impacts on our
internal control over financial reporting as a result of this change.
No other significant changes in our internal control over financial reporting (as defined in Rule 13a-15(f)
under the Securities Exchange Act of 1934) occurred during the quarter ended June 30, 2007 that has
materially affected, or is reasonably likely to materially affect, our internal control over
financial reporting.
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PART II. OTHER INFORMATION
Item 1.
Legal Proceedings
We are a party to litigation in the ordinary course of business. We do not believe that any such
litigation will have a material adverse effect on our business, financial condition or results of
operations.
Item 1A. Risk Factors
There are no material changes from the risk factors previously disclosed in the Companys Form
8-K form as of March 27, 2007 in response to Item 1A. to Part 1 of Form 10-K.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
On June 22, 2007, we issued 45,758,900 shares of our common stock in exchange for 457,589 shares of
our Series C preferred stock which automatically converted on a one-hundred-for-one basis (subject
to certain adjustments), as our common stock traded above the $3.83 per share conversion price on
the American Stock Exchange for ten consecutive trading days. The sale of such shares was deemed
to be exempt from registration under Section 3(a)(9) of the 1933 Act. The purchasers of such common
stock acquired these securities for their own accounts.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Submission of Matters to a Vote of Security Holders
On May 16, 2007, we filed with the SEC a definitive Information Statement on Schedule 14C, whereby
the Company acted by written consent of a majority of its shareholders, in approving (i) the
ratification of the appointment of Ernst & Young LLP as our independent registered public
accounting firm for 2007, (ii) our 2007 Equity Incentive Plan, (iii) the change of our name to OPKO
Health, Inc. and (iv) the Amendment and Restatement of our Certificate of Incorporation to increase
the authorized number of common shares from 225,000,000 to 500,000,000 and to effect the change of
our name to OPKO Health, Inc. The Information Statement indicated that these actions shall not
become effective until at least twenty (20) days after the Information Statement was sent to
shareholders. The actions contemplated by the Information Statement were effected on or about the
close of business on June 5, 2007.
Item 5. Other Information
None.
Item 6. Exhibits.
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Exhibit 10.1*
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Merger Agreement and Plan of Reorganization, dated March 27, 2007, by
and among eXegenics Inc. a Delaware corporation (eXegenics), Acuity
Pharmaceuticals, Inc., a Delaware corporation, Froptix Corporation, a Florida
corporation e-Acquisition Company I-A, LLC, a Delaware limited liability
company, which is a wholly owned subsidiary of eXegenics and e-Acquisition
Company II-B, LLC, a Delaware limited liability company which is a wholly owned
subsidiary of eXegenics. |
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Exhibit 10.2*
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Credit Agreement, dated as of March 27, 2007, by and among eXegenics
Inc., The Frost Group, LLC, and Acuity Pharmaceuticals, LLC. |
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Exhibit 10.3*
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Amended and Restated Venture Loan and Security Agreement, dated as
March 27, 2007, by and among Horizon Technology Funding Company LLC, Acuity
Pharmaceuticals, LLC and eXegenics, Inc. |
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Exhibit 10.4*
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Amended and Restated Subordination Agreement, dated as of March 27,
2007, by and among The Frost Group, LLC, Horizon Technology Funding Company
LLC, Acuity Pharmaceuticals, LLC, and eXegenics Inc. |
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Exhibit 31.1
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Certification by Phillip Frost, Chief Executive Officer, pursuant to
Rule 13a-14(a) and 15d-14(a) of the Securities and Exchange Act of 1934 as
adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 for the
quarterly period ended June 30, 2007. |
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Exhibit 31.2
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Certification by Rao Uppaluri, Chief Financial Officer, pursuant to
Rule 13a-14(a) and 15d-14(a) of the Securities and Exchange Act of 1934 as
adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 for the
quarterly period ended June 30, 2007. |
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Exhibit 32.1
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Certification by Phillip Frost, Chief Executive Officer pursuant to 18
U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002 for the quarterly period ended June 30, 2007. |
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Exhibit 32.2
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Certification by Rao Uppaluri, Chief Financial Officer pursuant to 18
U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002 for the quarterly period ended June 30, 2007. |
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Exhibit 99.1
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Financials of Ophthalmic
Technologies, Inc. |
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(*) |
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Incorporated by reference to Current Report on Form 8-K filed on April
2, 2007. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant
has caused this Report on Form 10-Q to be signed on its behalf by the undersigned
thereunto duly authorized.
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Date: August 13, 2007 |
OPKO Health, Inc.
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/s/
Rao Uppaluri |
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Rao Uppaluri |
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Senior Vice President and
Chief Financial Officer |
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