geron_10q.htm
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON D.C.
20549
_______________
FORM 10-Q
_______________
(Mark One)
x |
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QUARTERLY REPORT PURSUANT TO SECTION 13
OR 15(d) OF THE SECURITIES EXCHANGE |
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ACT OF 1934 |
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For the quarterly period ended June 30,
2010 |
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OR |
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o |
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TRANSITION REPORT PURSUANT TO SECTION 13
OR 15(d) OF THE SECURITIES EXCHANGE |
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ACT OF
1934 |
For the transition period from _____ to
_____.
Commission File Number:
0-20859
________________
GERON CORPORATION
(Exact name of registrant as specified in its charter)
DELAWARE |
75-2287752 |
(State or other jurisdiction
of |
(I.R.S. Employer |
incorporation or
organization) |
Identification No.) |
|
|
230 CONSTITUTION DRIVE, MENLO PARK,
CA |
94025 |
(Address of principal executive
offices) |
(Zip
Code) |
(650) 473-7700
(Registrant’s telephone number, including area code)
N/A
(Former name, former address and former fiscal year, if changed since
last report)
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 has submitted
electronically and posted on its corporate website, if any, every Interactive
Data File required to be submitted and posted pursuant to Rule 405 of Regulation
S-T (§232.405 of this chapter) during the preceding 12 months (or for such
shorter period that the registrant was required to submit and post such files).
Yes o No o
Indicate by check mark whether the registrant is a large accelerated
filer, an accelerated filer, a non-accelerated filer, or a smaller reporting
company. See the definitions of “large accelerated filer,” “accelerated filer,”
and “smaller reporting company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer |
o |
Accelerated filer |
x |
Non-accelerated filer |
o |
Smaller reporting company |
o |
(Do not check if a smaller reporting
company) |
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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
Indicate the number of shares
outstanding of each of the issuer’s classes of common stock, as of the latest
practicable date.
Class: |
Outstanding at July 26,
2010: |
Common Stock, $0.001 par value |
101,926,643 shares |
GERON CORPORATION
INDEX
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Page |
PART I. FINANCIAL
INFORMATION |
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Item 1: |
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Condensed Consolidated Financial Statements |
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1 |
|
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Condensed Consolidated Balance Sheets as
of June 30, 2010 and December 31, 2009 |
|
1 |
|
|
Condensed Consolidated
Statements of Operations for the three and six months ended June 30, 2010
and 2009 |
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2 |
|
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Condensed
Consolidated Statements of Cash Flows for the six months ended June 30,
2010 and 2009 |
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3 |
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Notes to Condensed Consolidated Financial Statements |
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4 |
Item 2: |
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Management’s Discussion and Analysis of
Financial Condition and Results of Operations |
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18 |
Item 3: |
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Quantitative and Qualitative Disclosures About Market
Risk |
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25 |
Item 4: |
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Controls and Procedures |
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26 |
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PART II. OTHER
INFORMATION |
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Item 1: |
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Legal Proceedings |
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26 |
Item 1A: |
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Risk Factors |
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26 |
Item 2: |
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Unregistered Sales of Equity Securities and Use of
Proceeds |
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42 |
Item 3: |
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Defaults Upon Senior
Securities |
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42 |
Item 4: |
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(Removed and Reserved) |
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42 |
Item 5: |
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Other Information |
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43 |
Item 6: |
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Exhibits |
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43 |
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SIGNATURE |
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43 |
PART I. FINANCIAL INFORMATION
ITEM 1. CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
GERON CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(IN
THOUSANDS)
|
|
JUNE 30, |
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DECEMBER 31, |
|
|
2010 |
|
2009 |
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|
(UNAUDITED) |
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ASSETS |
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Current assets: |
|
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|
|
|
|
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Cash and cash
equivalents
|
|
$ |
37,315 |
|
|
$ |
34,601 |
|
Restricted
cash
|
|
|
792 |
|
|
|
791 |
|
Current portion of marketable
securities |
|
|
83,789 |
|
|
|
77,009 |
|
Interest and other receivables |
|
|
1,390 |
|
|
|
1,318 |
|
Current portion of prepaid
assets |
|
|
7,662 |
|
|
|
4,060 |
|
Total current assets |
|
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130,948 |
|
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|
117,779 |
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Noncurrent portion of marketable
securities |
|
|
34,100 |
|
|
|
54,669 |
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Noncurrent portion of prepaid assets |
|
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1,867 |
|
|
|
2,372 |
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Investments in licensees |
|
|
437 |
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1,328 |
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Property and equipment, net |
|
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3,499 |
|
|
|
3,938 |
|
Deposits and other assets |
|
|
284 |
|
|
|
296 |
|
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$ |
171,135 |
|
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$ |
180,382 |
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LIABILITIES AND STOCKHOLDERS’
EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
1,715 |
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$ |
2,176 |
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Accrued compensation |
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2,246 |
|
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|
1,757 |
|
Accrued liabilities |
|
|
1,485 |
|
|
|
1,925 |
|
Current portion of deferred
revenue |
|
|
700 |
|
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|
700 |
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Fair value of derivatives |
|
|
667 |
|
|
|
897 |
|
Total current
liabilities |
|
|
6,813 |
|
|
|
7,455 |
|
Noncurrent portion of deferred
revenue |
|
|
— |
|
|
|
350 |
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Commitments and contingencies |
|
|
|
|
|
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Stockholders’ equity: |
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|
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Common stock |
|
|
99 |
|
|
|
92 |
|
Additional paid-in capital |
|
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775,432 |
|
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|
750,158 |
|
Accumulated deficit |
|
|
(610,938 |
) |
|
|
(577,267 |
) |
Accumulated other comprehensive
loss |
|
|
(271 |
) |
|
|
(406 |
) |
Total stockholders’
equity |
|
|
164,322 |
|
|
|
172,577 |
|
|
|
$ |
171,135 |
|
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$ |
180,382 |
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|
|
|
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See accompanying
notes.
1
GERON CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS
(IN THOUSANDS, EXCEPT SHARE AND PER SHARE DATA)
(UNAUDITED)
|
|
THREE MONTHS ENDED |
|
SIX MONTHS ENDED |
|
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JUNE 30, |
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JUNE 30, |
|
|
2010 |
|
2009 |
|
2010 |
|
2009 |
Revenues from collaborative
agreements |
|
$
|
225 |
|
|
$
|
— |
|
|
$
|
450 |
|
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$
|
— |
|
License fees and royalties |
|
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776 |
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183 |
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1,469 |
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|
627 |
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Total revenues |
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1,001 |
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|
183 |
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1,919 |
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|
627 |
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Operating expenses: |
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Research and
development (including amounts for
|
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related parties: three months -
2010-$317; 2009- |
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$502; six months – 2010-$644;
2009-$931) |
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13,389 |
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15,112 |
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26,934 |
|
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28,883 |
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General and administrative |
|
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4,488 |
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3,828 |
|
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8,338 |
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|
|
7,206 |
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Total operating expenses |
|
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17,877 |
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|
|
18,940 |
|
|
|
35,272 |
|
|
|
36,089 |
|
Loss from operations |
|
|
(16,876 |
) |
|
|
(18,757 |
) |
|
|
(33,353 |
) |
|
|
(35,462 |
) |
Unrealized gain (loss) on derivatives, net |
|
|
172 |
|
|
|
(1,330 |
) |
|
|
230 |
|
|
|
(1,253 |
) |
Interest and other income |
|
|
194 |
|
|
|
363 |
|
|
|
396 |
|
|
|
888 |
|
Losses recognized under equity method investment |
|
|
(496 |
) |
|
|
— |
|
|
|
(892 |
) |
|
|
(656 |
) |
Interest and other expense |
|
|
(25 |
) |
|
|
(34 |
) |
|
|
(52 |
) |
|
|
(86 |
) |
Net loss |
|
|
(17,031 |
) |
|
|
(19,758 |
) |
|
|
(33,671 |
) |
|
|
(36,569 |
) |
Deemed dividend on derivatives |
|
|
— |
|
|
|
(190 |
) |
|
|
— |
|
|
|
(190 |
) |
Net loss applicable to
common stockholders |
|
$ |
(17,031 |
) |
|
$ |
(19,948 |
) |
|
$ |
(33,671 |
) |
|
$ |
(36,759 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Basic and diluted net loss per share
applicable to |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
common stockholders |
|
$ |
(0.18 |
) |
|
$ |
(0.23 |
) |
|
$ |
(0.35 |
) |
|
$ |
(0.43 |
) |
|
|
|
|
|
|
|
|
|
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|
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|
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Shares used in computing basic and
diluted net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
per share applicable to common
stockholders |
|
|
96,712,059 |
|
|
|
88,547,553 |
|
|
|
95,862,080 |
|
|
|
86,354,221 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
See accompanying
notes.
2
GERON CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CASH
FLOWS
CHANGE IN CASH AND CASH EQUIVALENTS
(IN THOUSANDS)
(UNAUDITED)
|
|
SIX MONTHS ENDED |
|
|
JUNE 30, |
|
|
2010 |
|
2009 |
Cash flows from operating
activities: |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(33,671 |
) |
|
$ |
(36,569 |
) |
Adjustments to reconcile net loss to net
cash used in operating activities: |
|
|
|
|
|
|
|
|
Depreciation and
amortization |
|
|
804 |
|
|
|
884 |
|
Accretion and amortization on investments,
net |
|
|
1,814 |
|
|
|
164 |
|
Loss on retirement/sale of property and
equipment |
|
|
53 |
|
|
|
1 |
|
Issuance of common stock in exchange for
services by non-employees |
|
|
2,193 |
|
|
|
1,388 |
|
Stock-based compensation for employees and
directors |
|
|
6,120 |
|
|
|
5,092 |
|
Amortization related to 401(k)
contributions |
|
|
352 |
|
|
|
299 |
|
Loss on investments in
licensees |
|
|
892 |
|
|
|
676 |
|
Unrealized (gain) loss on derivatives,
net |
|
|
(230 |
) |
|
|
1,253 |
|
Changes in assets and liabilities: |
|
|
|
|
|
|
|
|
Other current and noncurrent
assets |
|
|
2,203 |
|
|
|
3,761 |
|
Other current and noncurrent
liabilities |
|
|
302 |
|
|
|
2,817 |
|
Advance payment from related party for
research |
|
|
|
|
|
|
|
|
and development |
|
|
— |
|
|
|
(313 |
) |
Translation adjustment |
|
|
(3 |
) |
|
|
— |
|
Net cash used in operating
activities |
|
|
(19,171 |
) |
|
|
(20,547 |
) |
|
|
|
|
|
|
|
|
|
Cash flows from investing
activities: |
|
|
|
|
|
|
|
|
Restricted cash transfer |
|
|
(1 |
) |
|
|
25 |
|
Purchases of property and
equipment |
|
|
(420 |
) |
|
|
(1,244 |
) |
Proceeds from sale of property and equipment |
|
|
2 |
|
|
|
— |
|
Purchases of marketable
securities |
|
|
(58,826 |
) |
|
|
(79,367 |
) |
Proceeds from maturities of marketable securities |
|
|
70,940 |
|
|
|
46,130 |
|
Net cash provided by (used in) investing
activities |
|
|
11,695 |
|
|
|
(34,456 |
) |
|
|
|
|
|
|
|
|
|
Cash flows from financing
activities: |
|
|
|
|
|
|
|
|
Proceeds from issuances of common stock and warrants, net of
issuance costs |
|
|
10,190 |
|
|
|
47,026 |
|
Net cash provided by financing
activities |
|
|
10,190 |
|
|
|
47,026 |
|
Net increase (decrease) in cash and cash equivalents |
|
|
2,714 |
|
|
|
(7,977 |
) |
Cash and cash equivalents at the
beginning of the period |
|
|
34,601 |
|
|
|
109,348 |
|
Cash and cash equivalents at the end of the period |
|
$ |
37,315 |
|
|
$ |
101,371 |
|
|
|
|
|
|
|
|
|
|
See accompanying
notes.
3
GERON CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30,
2010
(UNAUDITED)
1. SUMMARY OF SIGNIFICANT ACCOUNTING
POLICIES
Basis of Presentation
The terms “Geron”, the “Company”, “we” and “us” as used in this report
refer to Geron Corporation. The accompanying unaudited condensed consolidated
balance sheet as of June 30, 2010 and condensed consolidated statements of
operations for the three and six months ended June 30, 2010 and 2009 have been
prepared in accordance with generally accepted accounting principles for interim
financial information and with the instructions to Form 10-Q and Article 10 of
Regulation S-X. Accordingly, they do not include all of the information and
footnotes required by U.S. generally accepted accounting principles for complete
financial statements. In the opinion of management of Geron, all adjustments
(consisting only of normal recurring accruals) considered necessary for a fair
presentation have been included. Operating results for the three and six month
periods ended June 30, 2010 are not necessarily indicative of the results that
may be expected for the year ending December 31, 2010 or any other period. These
financial statements and notes should be read in conjunction with the financial
statements for each of the three years ended December 31, 2009, included in the
Company’s Annual Report on Form 10-K. The accompanying condensed consolidated
balance sheet as of December 31, 2009 has been derived from audited financial
statements at that date.
Principles of Consolidation
The consolidated financial statements include the accounts of Geron, our
wholly-owned subsidiary, Geron Bio-Med Ltd. (Geron Bio-Med), a United Kingdom
company, and our majority-owned subsidiary, TA Therapeutics, Ltd. (TAT), a Hong
Kong company. We have eliminated intercompany accounts and transactions. We
prepare the financial statements of Geron Bio-Med using the local currency as
the functional currency. We translate the assets and liabilities of Geron
Bio-Med at rates of exchange at the balance sheet date and translate income and
expense items at average monthly rates of exchange. The resultant translation
adjustments are included in accumulated other comprehensive income (loss), a
separate component of stockholders’ equity. The functional currency for TAT is
U.S. dollars. See Note 8 on Subsequent Event for the current status of
TAT.
Net Loss Per Share
Basic earnings (loss) per share is calculated based on the weighted
average number of shares of common stock outstanding during the period. Diluted
earnings (loss) per share is calculated based on the weighted average number of
shares of common stock and dilutive securities outstanding during the period.
Potential dilutive securities primarily consist of outstanding employee stock
options, restricted stock and warrants to purchase common stock and are
determined using the treasury stock method at an average market price during the
period.
Because we were in a net loss position, diluted earnings per share
excludes the effects of potential dilutive securities. Had we been in a net
income position, diluted earnings per share would have included the shares used
in the computation of basic net loss per share as well as an additional
1,182,957 and 1,011,597 shares for 2010 and 2009, respectively, related to
outstanding options, restricted stock and warrants (as determined using the
treasury stock method at the estimated average market value).
Use of Estimates
The preparation of financial statements in conformity with accounting
principles generally accepted in the United States requires us to make estimates
and assumptions that affect the amounts reported in the financial statements and
accompanying notes. On a regular basis, management evaluates these estimates and
assumptions. Actual results could differ from those estimates.
4
GERON CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30,
2010
(UNAUDITED)
Fair Value of Financial Instruments
Cash Equivalents and Marketable
Securities
We consider all highly liquid investments with an original maturity of
three months or less to be cash equivalents. We are subject to credit risk
related to our cash equivalents and marketable securities. We place our cash and
cash equivalents in money market funds, municipal securities and corporate
notes. Our current investments include U.S. government-sponsored enterprise
securities, commercial paper and corporate notes with original maturities
ranging from four to 24 months.
We classify our marketable securities as available-for-sale. We record
available-for-sale securities at fair value with unrealized gains and losses
reported in accumulated other comprehensive income (loss) in stockholders’
equity. Realized gains and losses are included in interest and other income and
are derived using the specific identification method for determining the cost of
securities sold and have been insignificant to date. Dividend and interest
income are recognized when earned and included in interest and other income in
our condensed consolidated statements of operations. We recognize a charge when
the declines in the fair values below the amortized cost basis of our
available-for-sale securities are judged to be other-than-temporary. We consider
various factors in determining whether to recognize an other-than-temporary
charge, including whether we intend to sell the security or whether it is more
likely than not that we would be required to sell the security. Declines in
market value associated with credit losses judged as other-than-temporary result
in a charge to interest and other income. Other-than-temporary charges not
related to credit losses are included in accumulated other comprehensive income
(loss) in stockholders’ equity. See Note 2 on Fair Value
Measurements.
Marketable and Non-Marketable Investments in
Licensees
Investments in non-marketable nonpublic companies, in which we own less
than 20% of the outstanding voting stock and do not otherwise have the ability
to exert significant influence over the investees, are carried at cost, as
adjusted for other-than-temporary impairments. Investments in marketable equity
securities are carried at fair value as of the balance sheet date with
unrealized gains and losses reported in accumulated other comprehensive income
(loss) in stockholders’ equity. Realized gains or losses are included in
interest and other income and are derived using the specific identification
method.
We apply the equity method of accounting for investments in licensees in
which we own more than 20% of the outstanding voting stock or otherwise have the
ability to exert significant influence over the investees. Under this method, we
increase (decrease) the carrying value of our investment by a proportionate
share of the investee’s earnings (losses). If losses exceed the carrying value
of the investment, losses are then applied against any advances to the investee,
including any commitment to provide financial support, until those amounts are
reduced to zero. The equity method is then suspended until the investee has
earnings. Any proportionate share of investee earnings is first applied to the
share of accumulated losses not recognized during the period the equity method
was suspended.
We monitor our investments in licensees for impairment on a quarterly
basis and make appropriate reductions in carrying values when such impairments
are determined to be other-than-temporary. Other-than-temporary charges are
included in interest and other income. Factors used in determining whether an
other-than-temporary charge should be recognized include, but are not limited
to: the current business environment including competition and uncertainty of
financial condition; going concern considerations such as the rate at which the
investee company utilizes cash, and the investee company’s ability to obtain
additional private financing to fulfill its stated business plan; the need for
changes to the investee company’s existing business model due to changing
business environments and its ability to successfully implement necessary
changes; and the general progress toward product development, including clinical
trial results. See Note 2 on Fair Value Measurements.
5
GERON CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30,
2010
(UNAUDITED)
Fair Value of Derivatives
For warrants and non-employee options classified as assets or
liabilities, the fair value of these instruments is recorded on the condensed
consolidated balance sheet at inception of such classification and adjusted to
fair value at each financial reporting date. The change in fair value of the
warrants and non-employee options is recorded in the condensed consolidated
statements of operations as unrealized gain (loss) on derivatives. Fair value of
warrants and non-employee options is estimated using the Black Scholes
option-pricing model. The warrants and non-employee options continue to be
reported as an asset or liability until such time as the instruments are
exercised or expire or are otherwise modified to remove the provisions which
require this treatment, at which time these instruments are marked to fair value
and reclassified from assets or liabilities to stockholders’ equity. For
warrants and non-employee options classified as permanent equity, the fair value
of the warrants and non-employee options is recorded in stockholders’ equity and
no further adjustments are made. See Note 2 on Fair Value
Measurements.
Revenue Recognition
We have several license agreements with various oncology, diagnostics,
research tools, agriculture and biologics production companies. With certain of
these agreements, we receive nonrefundable license payments in cash or equity
securities, option payments in cash or equity securities, royalties on future
sales of products, milestone payments, or any combination of these items.
Upfront nonrefundable signing, license or non-exclusive option fees are
recognized as revenue when rights to use the intellectual property related to
the license have been delivered and over the term of the agreement if we have
continuing performance obligations. Milestone payments, which are subject to
substantive contingencies, are recognized upon completion of specified
milestones, representing the culmination of the earnings process, according to
contract terms. Royalties are generally recognized upon receipt of the related
royalty payment. Deferred revenue represents the portion of research and license
payments received which has not been earned. When payments are received in
equity securities, we do not recognize any revenue unless such securities are
determined to be realizable in cash.
We recognize revenue under collaborative agreements as the related
research and development costs for services are rendered. We recognize related
party revenue under collaborative agreements as the related research and
development costs for services are rendered and when the source of funds have
not been derived from our contributions to the related party.
Restricted Cash
The components of restricted cash
were as follows:
|
|
June 30, |
|
December 31, |
|
|
2010 |
|
2009 |
|
|
(In thousands) |
Certificate of deposit for unused
equipment line of credit |
|
$
|
530 |
|
$
|
530 |
Certificate of deposit for credit card purchases |
|
|
262 |
|
|
261 |
|
|
$ |
792 |
|
$ |
791 |
|
|
|
|
|
|
|
Research and Development Expenses
All research and development costs are expensed as incurred. The value of
acquired in-process research and development is charged to research and
development expense on the date of acquisition, if not acquired in connection
with a business combination. Research and development expenses include, but are
not limited to, acquired in-process technology deemed to have no alternative
future use, payroll and personnel expense, lab supplies, preclinical studies,
raw materials to manufacture clinical trial drugs, manufacturing costs for
research and clinical trial materials, sponsored research at other labs,
consulting, costs to maintain technology licenses and research-related
overhead.
6
GERON CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30,
2010
(UNAUDITED)
Depreciation and Amortization
We record property and equipment at cost and calculate depreciation using
the straight-line method over the estimated useful lives of the assets,
generally four years. Leasehold improvements are amortized over the shorter of
the estimated useful life or remaining term of the lease.
Stock-Based Compensation
We recognize compensation expense on a straight-line basis for
stock-based awards granted after January 1, 2006, plus unvested awards granted
prior to January 1, 2006 based on the grant-date fair value estimated using
accounting guidance in effect at that time and following the straight-line
attribution method.
The following table summarizes the stock-based compensation expense
related to stock options, restricted stock awards and employee stock purchases
for the three and six months ended June 30, 2010 and 2009 which was allocated as
follows:
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
2010 |
|
2009 |
|
2010 |
|
2009 |
|
|
(In thousands) |
Research and development |
|
$
|
1,096 |
|
$
|
1,111 |
|
$
|
2,743 |
|
$
|
2,337 |
General and administrative |
|
|
1,955 |
|
|
1,461 |
|
|
3,377 |
|
|
2,755 |
Stock-based compensation expense
included in |
|
|
|
|
|
|
|
|
|
|
|
|
operating expenses |
|
$ |
3,051 |
|
$ |
2,572 |
|
$ |
6,120 |
|
$ |
5,092 |
|
|
|
|
|
|
|
|
|
|
|
|
|
In May 2010, the vesting of certain outstanding restricted stock awards
and the exercise periods of certain outstanding stock options were modified in
connection with the retirement of a board member. Stock-based compensation
expense of approximately $494,000 has been included in general and
administrative expense for the modifications.
Stock Options
The fair value of options granted during the six months ended June 30,
2010 and 2009 has been estimated at the date of grant using the Black Scholes
option-pricing model with the following assumptions:
|
|
Six Months Ended June
30, |
|
|
2010 |
|
2009 |
Dividend yield |
|
None |
|
None |
Expected volatility range |
|
0.627 to 0.629 |
|
0.630 to 0.631 |
Risk-free interest rate range |
|
2.13% to 2.65% |
|
1.54% to 2.34% |
Expected term |
|
5 yrs |
|
5
yrs |
Employee Stock Purchase
Plan
The fair value of employees’ purchase rights during the six months ended
June 30, 2010 and 2009 has been estimated using the Black Scholes option-pricing
model with the following assumptions:
|
|
Six Months Ended June
30, |
|
|
2010 |
|
2009 |
Dividend yield |
|
None |
|
None |
Expected volatility range |
|
0.592 to 0.995 |
|
0.536 to 1.016 |
Risk-free interest rate range |
|
0.18% to 0.54% |
|
0.28% to 2.38% |
Expected term range |
|
6 - 12 mos |
|
6 - 12
mos |
7
GERON CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30,
2010
(UNAUDITED)
Dividend yield is based on historical cash dividend payments, which have
been none to date. The expected volatility range is based on historical
volatilities of our stock since traded options on Geron stock do not correspond
to option terms and the trading volume of options is limited. The risk-free
interest rate range is based on the U.S. Zero Coupon Treasury Strip Yields for
the expected term in effect on the date of grant for an award. The expected term
of options is derived from actual historical exercise data and represents the
period of time that options granted are expected to be outstanding. The expected
term of employees’ purchase rights is equal to the purchase period. We grant
options under our equity plans to employees, non-employee directors and
consultants, for whom the vesting period is generally four years.
As stock-based compensation expense recognized in the condensed
consolidated statements of operations for the three and six months ended June
30, 2010 and 2009 is based on awards ultimately expected to vest, it has been
reduced for estimated forfeitures but at a minimum, reflects the grant-date fair
value of those awards that actually vested in the period. Forfeitures have been
estimated at the time of grant based on historical experience and revised, if
necessary, in subsequent periods if actual forfeitures differ from those
estimates.
Restricted Stock Awards
The stock-based compensation expense related to restricted stock awards
is determined using the fair value of our common stock on the date of grant and
reduced for estimated forfeitures as applicable. The fair value is amortized as
compensation expense over the service period of the award on a straight-line
basis.
Non-Employee Stock-Based
Awards
For our non-employee stock-based awards, the measurement date on which
the fair value of the stock-based award is calculated is equal to the earlier of
(i) the date at which a commitment for performance by the counterparty to earn
the equity instrument is reached or (ii) the date at which the counterparty’s
performance is complete. We recognize stock-based compensation expense for the
fair value of the vested portion of non-employee awards in our condensed
consolidated statements of operations.
Comprehensive Loss
Comprehensive loss is comprised of net loss and other comprehensive
income (loss). Other comprehensive income (loss) includes certain changes in
stockholders’ equity which are excluded from net loss. The activity in
comprehensive loss during the three and six months ended June 30, 2010 and 2009
was as follows:
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
|
|
2010 |
|
2009 |
|
2010 |
|
2009 |
|
|
(In thousands) |
Net loss |
|
$
|
(17,031 |
) |
|
$
|
(19,758 |
) |
|
$
|
(33,671 |
) |
|
$
|
(36,569 |
) |
Change in net unrealized loss on available-for-sale |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
securities and marketable
investments in licensees |
|
|
5 |
|
|
|
(73 |
) |
|
|
138 |
|
|
|
(70 |
) |
Change in foreign currency translation adjustments |
|
|
— |
|
|
|
1 |
|
|
|
(3 |
) |
|
|
1 |
|
Comprehensive loss |
|
$ |
(17,026 |
) |
|
$ |
(19,830 |
) |
|
$ |
(33,536 |
) |
|
$ |
(36,638 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The components of accumulated other
comprehensive loss were as follows:
|
|
June 30, 2010 |
|
December 31, 2009 |
|
|
(In thousands) |
Unrealized loss on available-for-sale
securities and |
|
|
|
|
|
|
|
|
marketable investments in licensees, net |
|
$ |
(96 |
) |
|
$
|
(234 |
) |
Foreign currency translation adjustments |
|
|
(175 |
) |
|
|
(172 |
) |
Accumulated other comprehensive
loss |
|
$ |
(271 |
) |
|
$ |
(406 |
) |
|
|
|
|
|
|
|
|
|
8
GERON CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2010
(UNAUDITED)
Recently Issued Accounting Guidance
In April 2010, the Financial Accounting Standards Board (FASB) ratified a
consensus of the FASB Emerging Issues Task Force that recognizes the milestone
method as an acceptable revenue recognition method for substantive milestones in
research or development arrangements. This consensus requires its provisions be
met in order for an entity to recognize consideration that is contingent upon
achievement of a substantive milestone as revenue in its entirety in the period
in which the milestone is achieved. In addition, this consensus would require
disclosure of certain information with respect to arrangements that contain
milestones. This authoritative guidance is effective for interim and annual
reporting periods beginning on or after June 15, 2010. The implementation of
this authoritative guidance is not expected to have a material impact on our
consolidated financial statements.
2. FAIR VALUE MEASUREMENTS
We categorize assets and liabilities recorded at fair value on our
condensed consolidated balance sheet based upon the level of judgment associated
with inputs used to measure their fair value. The categories are as follows:
Level 1 – Inputs are unadjusted, quoted prices in active markets for
identical assets or liabilities at the measurement date. An active market for
the asset or liability is a market in which transactions for the asset or
liability occur with sufficient frequency and volume to provide pricing
information on an ongoing basis.
Level 2 – Inputs (other than quoted market prices included in Level 1)
are either directly or indirectly observable for the asset or liability through
correlation with market data at the measurement date and for the duration of the
instrument’s anticipated life.
Level 3 – Inputs reflect management’s best estimate of what market
participants would use in pricing the asset or liability at the measurement
date. Consideration is given to the risk inherent in the valuation technique and
the risk inherent in the inputs to the model.
A financial instrument’s categorization within the valuation hierarchy is
based upon the lowest level of input that is significant to the fair value
measurement. Following is a description of the valuation methodologies used for
instruments measured at fair value on our condensed consolidated balance sheet,
including the category for such instruments.
Cash Equivalents and Marketable Securities
Available-for-Sale
Where quoted prices are available in an active market, securities are
categorized as Level 1. Examples of such Level 1 securities include U.S.
Treasury securities, U.S. government-sponsored enterprise securities, municipal
securities and money market funds. If quoted market prices are not available for
the specific security, then fair values are estimated by using pricing models,
quoted prices of securities with similar characteristics or discounted cash
flows. Examples of such Level 2 securities include corporate notes, asset-backed
securities and commercial paper.
9
GERON CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2010
(UNAUDITED)
Marketable securities by security
type at June 30, 2010 were as follows:
|
|
|
|
Gross |
|
Gross |
|
Estimated |
|
|
|
|
Unrealized |
|
Unrealized |
|
Fair |
|
Cost |
|
Gains |
|
Losses |
|
Value |
|
(In thousands) |
Included in cash and cash
equivalents: |
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
$ |
17,106 |
|
$ |
— |
|
$ |
— |
|
|
$ |
17,106 |
Municipal securities |
|
13,160 |
|
|
— |
|
|
— |
|
|
|
13,160 |
Corporate notes |
|
5,761 |
|
|
2 |
|
|
(2 |
) |
|
|
5,761 |
|
$ |
36,027 |
|
$ |
2 |
|
$ |
(2 |
) |
|
$ |
36,027 |
Restricted cash: |
|
|
|
|
|
|
|
|
|
|
|
|
Certificates of deposit |
$ |
792 |
|
$ |
— |
|
$ |
— |
|
|
$ |
792 |
Marketable securities: |
|
|
|
|
|
|
|
|
|
|
|
|
Government-sponsored enterprise
securities |
|
|
|
|
|
|
|
|
|
|
|
|
(due in less than 1
year) |
$ |
12,444 |
|
$ |
2 |
|
$ |
(1 |
) |
|
$ |
12,445 |
Government-sponsored enterprise
securities |
|
|
|
|
|
|
|
|
|
|
|
|
(due in 1 to 2 years) |
|
2,000 |
|
|
— |
|
|
— |
|
|
|
2,000 |
Commercial paper (due in less than 1
year) |
|
14,978 |
|
|
14 |
|
|
— |
|
|
|
14,992 |
Corporate notes (due in less than 1
year) |
|
56,439 |
|
|
— |
|
|
(87 |
) |
|
|
56,352 |
Corporate notes (due in 1 to 2
years) |
|
32,124 |
|
|
10 |
|
|
(34 |
) |
|
|
32,100 |
Investments in licensees |
|
1 |
|
|
— |
|
|
— |
|
|
|
1 |
|
$ |
117,986 |
|
$ |
26 |
|
$ |
(122 |
) |
|
$ |
117,890 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Marketable securities by security
type at December 31, 2009 were as follows:
|
|
|
|
Gross |
|
Gross |
|
Estimated |
|
|
|
|
Unrealized |
|
Unrealized |
|
Fair |
|
Cost |
|
Gains |
|
Losses |
|
Value |
|
(In thousands) |
Included in cash and cash
equivalents: |
|
|
|
|
|
|
|
|
|
|
|
|
Money market funds |
$ |
33,395 |
|
$ |
— |
|
$ |
— |
|
|
$ |
33,395 |
Restricted cash: |
|
|
|
|
|
|
|
|
|
|
|
|
Certificates of deposit |
$ |
791 |
|
$ |
— |
|
$ |
— |
|
|
$ |
791 |
Marketable securities: |
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Treasury securities (due in less than 1
year) |
$ |
58,146 |
|
$ |
20 |
|
$ |
(7 |
) |
|
$ |
58,159 |
Government-sponsored enterprise
securities |
|
|
|
|
|
|
|
|
|
|
|
|
(due in 1 to 2 years) |
|
14,058 |
|
|
— |
|
|
(37 |
) |
|
|
14,021 |
Corporate notes (due in less than 1
year) |
|
18,847 |
|
|
11 |
|
|
(8 |
) |
|
|
18,850 |
Corporate notes (due in 1 to 2
years) |
|
40,861 |
|
|
— |
|
|
(213 |
) |
|
|
40,648 |
|
$ |
131,912 |
|
$ |
31 |
|
$ |
(265 |
) |
|
$ |
131,678 |
|
|
|
|
|
|
|
|
|
|
|
|
|
10
GERON CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2010
(UNAUDITED)
Marketable securities with
unrealized losses at June 30, 2010 and December 31, 2009 were as follows:
|
Less Than 12 Months |
|
12 Months or Greater |
|
Total |
|
|
|
|
Gross |
|
|
|
|
Gross |
|
|
|
|
Gross |
|
Estimated |
|
Unrealized |
|
Estimated |
|
Unrealized |
|
Estimated |
|
Unrealized |
|
Fair Value |
|
Losses |
|
Fair Value |
|
Losses |
|
Fair Value |
|
Losses |
|
(In thousands) |
As of June 30, 2010: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Government-sponsored enterprise |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
securities (due in less than 1
year) |
$ |
1,259 |
|
$ |
(1 |
) |
|
$ |
— |
|
$ |
— |
|
$ |
1,259 |
|
$ |
(1 |
) |
Corporate notes (due in less than 1
year) |
|
48,441 |
|
|
(89 |
) |
|
|
— |
|
|
— |
|
|
48,441 |
|
|
(89 |
) |
Corporate notes (due in 1 to 2 years) |
|
11,648 |
|
|
(34 |
) |
|
|
— |
|
|
— |
|
|
11,648 |
|
|
(34 |
) |
|
$ |
61,348 |
|
$ |
(124 |
) |
|
$ |
— |
|
$ |
— |
|
$ |
61,348 |
|
$ |
(124 |
) |
|
As of December 31,
2009: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Treasury securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(due in less than 1 year) |
$ |
18,859 |
|
$ |
(7 |
) |
|
$ |
— |
|
$ |
— |
|
$ |
18,859 |
|
$ |
(7 |
) |
Government-sponsored
enterprise |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
securities (due in 1 to 2
years) |
|
14,021 |
|
|
(37 |
) |
|
|
— |
|
|
— |
|
|
14,021 |
|
|
(37 |
) |
Corporate notes (due in less than 1 year) |
|
7,524 |
|
|
(8 |
) |
|
|
— |
|
|
— |
|
|
7,524 |
|
|
(8 |
) |
Corporate notes (due in 1 to 2
years) |
|
40,648 |
|
|
(213 |
) |
|
|
— |
|
|
— |
|
|
40,648 |
|
|
(213 |
) |
|
$ |
81,052 |
|
$ |
(265 |
) |
|
$ |
— |
|
$ |
— |
|
$ |
81,052 |
|
$ |
(265 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The gross unrealized losses related to U.S. Treasury securities, U.S.
government-sponsored enterprise securities and corporate notes as of June 30,
2010 and December 31, 2009, were due to changes in interest rates. We determined
the gross unrealized losses on our marketable securities as of June 30, 2010 and
December 31, 2009 were temporary in nature. We review our investments quarterly
to identify and evaluate whether any investments have an indication of possible
impairment. Factors considered in determining whether a loss is temporary
include the length of time and extent to which the fair value has been less than
cost basis, the financial condition and near-term prospects of the investee, and
whether we intend to sell the security or whether it is more likely than not
that we would be required to sell the security.
Marketable and Non-Marketable Investments in
Licensees
Where quoted prices are available in an active market, securities are
categorized as Level 1. Level 1 securities include publicly traded equities.
Significant investments in licensees accounted for using the equity method of
accounting or equity securities in non-marketable companies are not measured at
fair value and are not assigned a category level.
As of June 30, 2010 and December 31, 2009, the carrying values of our
investments in non-marketable nonpublic companies were $436,000 and $1,328,000,
respectively. We recognized no charges related to other-than-temporary declines
in fair values of investments in licensees for the three and six months ended
June 30, 2010 and 2009. See Note 3 on Joint Venture and Related Party
Transactions for further discussion of investments in licensees.
Derivatives
Warrants to purchase common stock and non-employee options are normally
traded less actively, have trade activity that is one way, and/or traded in
less-developed markets and are therefore valued based upon models with
significant unobservable market parameters, resulting in Level 3
categorization.
11
GERON CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2010
(UNAUDITED)
The fair value of derivatives has
been calculated at each reporting date using the Black Scholes option-pricing
model with the following assumptions:
|
June 30, 2010 |
|
December 31, 2009 |
Dividend yield |
None |
|
None |
Expected volatility range |
0.627 |
|
0.607 to 0.632 |
Risk-free interest rate range |
1.79% |
|
0.06% to 2.69% |
Expected term range |
5 yrs |
|
4 mos to 5
yrs |
Dividend yield is based on historical cash dividend payments, which have
been none to date. The expected volatility range is based on historical
volatilities of our stock since traded options on Geron stock do not correspond
to derivatives’ terms and trading volume of Geron options is limited. The
risk-free interest rate range is based on the U.S. Zero Coupon Treasury Strip
Yields for the expected term in effect on the reporting date. The expected term
of derivatives is equal to the remaining contractual term of the instrument.
As of June 30, 2010 and December 31, 2009, the following warrants and
non-employee options to purchase common stock were considered derivatives and
classified as current liabilities:
|
|
|
|
|
|
|
|
|
At June 30, 2010 |
|
At December 31, 2009 |
|
|
|
|
|
|
|
|
|
Number |
|
Fair |
|
Number |
|
Fair |
Issuance |
|
Exercise |
|
Exercisable |
|
Expiration |
|
of |
|
Value |
|
of |
|
Value |
Date |
|
Price |
|
Date |
|
Date |
|
Shares |
|
(In thousands) |
|
Shares |
|
(In
thousands) |
April 2005 |
|
$ |
7.95 |
|
April 2005 |
|
April 2010 |
|
— |
|
$ |
— |
|
351,852 |
|
$ |
58 |
March 2005 |
|
$ |
6.39 |
|
January 2007 |
|
March 2015 |
|
284,600 |
|
|
667 |
|
284,600 |
|
|
839 |
|
|
|
|
|
|
|
|
|
284,600 |
|
$ |
667 |
|
636,452 |
|
$ |
897 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
No reclassifications from current liabilities to stockholders’ equity
were made for derivatives during the three and six months ended June 30,
2010.
Fair Value on a Recurring Basis
The following table presents information about our financial assets and
liabilities that are measured at fair value on a recurring basis as of June 30,
2010, and indicates the fair value category assigned.
|
Fair Value Measurements at Reporting
Date Using |
|
|
|
|
Significant |
|
|
|
|
|
|
|
Quoted Prices in |
|
Other |
|
Significant |
|
|
|
|
Active Markets for |
|
Observable |
|
Unobservable |
|
|
|
|
Identical Assets |
|
Inputs |
|
Inputs |
|
|
|
(In thousands) |
Level 1 |
|
Level 2 |
|
Level 3 |
|
Total |
Assets |
|
|
|
|
|
|
|
|
|
|
|
Money market funds (1) |
$ |
17,106 |
|
$ |
— |
|
$ |
— |
|
$ |
17,106 |
Municipal securities (1) |
|
13,160 |
|
|
— |
|
|
— |
|
|
13,160 |
Government-sponsored enterprise securities (2) |
|
14,445 |
|
|
— |
|
|
— |
|
|
14,445 |
Commercial paper (2) |
|
— |
|
|
14,992 |
|
|
— |
|
|
14,992 |
Corporate notes (3) |
|
— |
|
|
94,213 |
|
|
— |
|
|
94,213 |
Marketable investments in licensees
(4) |
|
1 |
|
|
— |
|
|
— |
|
|
1 |
Total |
$ |
44,712 |
|
$ |
109,205 |
|
$ |
— |
|
$ |
153,917 |
|
|
|
|
|
|
|
|
|
|
|
|
12
GERON CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2010
(UNAUDITED)
|
Fair Value Measurements at Reporting
Date Using |
|
|
|
|
Significant |
|
|
|
|
|
|
|
Quoted Prices in |
|
Other |
|
Significant |
|
|
|
|
Active Markets for |
|
Observable |
|
Unobservable |
|
|
|
|
Identical Assets |
|
Inputs |
|
Inputs |
|
|
|
(In thousands) |
Level 1 |
|
Level 2 |
|
Level 3 |
|
Total |
Liabilities |
|
|
|
|
|
|
|
|
|
|
|
Derivatives (5) |
$ |
— |
|
$ |
— |
|
$ |
667 |
|
$ |
667 |
____________________ |
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Included in cash and cash equivalents on our condensed consolidated
balance sheets. |
|
(2) |
|
Included in current and noncurrent marketable securities on our
condensed consolidated balance sheets. |
|
(3) |
|
Included in cash and cash equivalents and current and noncurrent
marketable securities on our condensed consolidated balance
sheets. |
|
(4) |
|
Included in investments in licensees on our condensed consolidated
balance sheets. |
|
(5) |
|
Included in fair value of derivatives on our condensed consolidated
balance sheets. |
|
Changes in Level 3 Recurring Fair Value
Measurements
The table below includes a rollforward of the balance sheet amounts for
the three and six months ended June 30, 2010 (including the change in fair
value), for financial instruments in the Level 3 category. When a determination
is made to classify a financial instrument within Level 3, the determination is
based upon the significance of the unobservable parameters to the overall fair
value measurement. However, Level 3 financial instruments typically include, in
addition to the unobservable components, observable components (that is,
components that are actively quoted and can be validated to external sources).
Accordingly, the gains and losses in the table below include changes in fair
value due in part to observable factors that are part of the
methodology.
|
|
Fair Value Measurements Using
Significant Unobservable Inputs (Level 3) |
|
|
Three Months Ended June 30,
2010 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized Gains |
|
|
|
|
|
Total |
|
|
|
|
|
|
|
|
|
|
Related to |
|
|
|
|
|
Unrealized |
|
Purchases, |
|
|
|
|
|
|
|
Financial |
|
|
|
|
|
Gains Included |
|
Sales, |
|
Transfers |
|
|
|
|
Instruments |
|
|
Fair Value at |
|
In |
|
Issuances, |
|
In and/or |
|
Fair Value
at |
|
Held at |
|
|
March 31, |
|
Earnings, net |
|
Settlements, |
|
Out of |
|
June 30, |
|
June 30, 2010 |
(In thousands) |
|
2010 |
|
(1) |
|
net |
|
Level 3 |
|
2010 |
|
(1) |
Derivative liabilities |
|
$ |
839 |
|
$ |
(172 |
) |
|
$ |
— |
|
$ |
— |
|
$ |
667 |
|
$ |
(172 |
) |
|
|
Fair Value Measurements Using
Significant Unobservable Inputs (Level 3) |
|
|
Six Months Ended June 30,
2010 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized Gains |
|
|
|
|
|
Total |
|
|
|
|
|
|
|
|
|
|
Related to |
|
|
|
|
|
Unrealized |
|
Purchases, |
|
|
|
|
|
|
|
Financial |
|
|
|
|
|
Gains Included |
|
Sales, |
|
Transfers |
|
|
|
|
Instruments |
|
|
Fair Value at |
|
In |
|
Issuances, |
|
In and/or |
|
Fair Value at |
|
Held at |
|
|
December 31, |
|
Earnings, net |
|
Settlements, |
|
Out of |
|
June 30, |
|
June 30, 2010 |
(In thousands) |
|
2009 |
|
(1) |
|
net |
|
Level 3 |
|
2010 |
|
(1) |
Derivative liabilities |
|
$ |
897 |
|
$ |
(230 |
) |
|
$ |
— |
|
$ |
— |
|
$ |
667 |
|
$ |
(172 |
) |
____________________
(1) Reported as unrealized gain on
derivatives in our condensed consolidated statements of operations.
13
GERON CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2010
(UNAUDITED)
3. JOINT VENTURE AND RELATED PARTY
TRANSACTIONS
Start Licensing and ViaGen, Inc.
In April 2005, Geron and Exeter Life Sciences, Inc. (Exeter) established
Start Licensing, Inc. (Start), a joint venture to manage and license a broad
portfolio of intellectual property rights related to animal reproductive
technologies. We and Exeter owned 49.9% and 50.1% of Start, respectively. In
connection with the establishment of Start, we granted a worldwide, exclusive,
non-transferable license to our patent rights to nuclear transfer technology for
use in animal cloning, with the right to sublicense such patent rights. Since
there was no net book value associated with the patent rights at the execution
of the joint venture, no initial value was recognized for our investment in
Start. We suspended the equity method of accounting since our proportionate
share of net losses in Start exceeded our original carrying value of the
investment and we had no commitments to provide financial support or obligations
to perform services or other activities for Start.
In August 2008, Geron and Exeter entered into Contribution Agreements
whereby we and Exeter exchanged our equity interests in Start for equity
interests in ViaGen, Inc. (ViaGen). As a result of the exchange, Start became a
wholly-owned subsidiary of ViaGen. Ownership of ViaGen immediately following the
transaction was as follows: Exeter – 69%; Geron – 27%; and Smithfield Foods –
4%. Since no value had been recorded for our investment in Start, the same zero
carrying value was applied to our investment in ViaGen. Geron’s share of equity
method losses from Start that were not recognized during the period the equity
method was suspended has been carried over to the investment in
ViaGen.
In September 2009, Geron made a net equity investment in ViaGen of
$2,010,000 and simultaneously Exeter converted its outstanding debt with ViaGen
into equity. The new equity purchase did not fund prior ViaGen losses and
represented additional financial support to ViaGen. Ownership of ViaGen upon
consummation of the transactions and at June 30, 2010 was as follows: Exeter –
70%; Geron – 28%; and Smithfield Foods – 2%. We have no commitments to provide
financial support or obligations to perform services or other activities for
ViaGen.
In applying the equity method of accounting to our investment in ViaGen,
we increase (decrease) the carrying value of our investment by our proportionate
share of ViaGen’s earnings (losses). If equity method losses exceed the carrying
value of the investment, losses will be applied against any advances to ViaGen,
including any commitments to provide financial support until those amounts are
reduced to zero. The equity method of accounting shall then be suspended until
income is subsequently reported. If income is reported, Geron’s proportionate
share of income shall first be applied to recognize the equity method losses
accumulated during the time the equity method was suspended.
For the three and six months ended June 30, 2010, we recognized $496,000
and $892,000, respectively, for our proportionate share of ViaGen’s operating
losses compared to none and $656,000 for the comparable 2009 periods. Our share
of losses is recorded in the condensed consolidated statements of operations
under losses recognized under equity method investment. The adjusted basis of
our investment in ViaGen at June 30, 2010 and December 31, 2009 was $436,000 and
$1,328,000, respectively, which is reflected under investments in licensees on
our condensed consolidated balance sheets.
TA Therapeutics, Ltd.
In March 2005, we and the Biotechnology Research Corporation (BRC), a
subsidiary of Hong Kong University of Science and Technology, established a
joint venture company in Hong Kong called TA Therapeutics, Ltd. (TAT). TAT
conducts research and was established to commercially develop products that
utilize telomerase activator drugs to restore the regenerative and functional
capacity of cells in various organ systems that have been impacted by
senescence, injury or chronic disease. On June 15, 2007, we and BRC entered into
an agreement to restructure the TAT joint venture. Under the amended agreements,
we direct the preclinical and drug development activities, own a 75% voting
interest and exercise control over the
company. Upon any winding up of TAT, all intellectual property of TAT is
assigned to us and BRC is entitled to royalties on sales of future products
developed from TAT’s efforts up to a fixed amount based on BRC’s cash
contributions. Upon a winding up of TAT, if the assets available for
distribution, other than the intellectual property, are insufficient to repay
the whole of the paid-up capital, such assets shall be distributed so that the
losses shall be borne by the shareholders in proportion to the cash contributed
by both parties. See Note 8 on Subsequent Event for the current status of TAT.
14
GERON CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2010
(UNAUDITED)
As a result of our obtaining control over TAT, we have included the
results of TAT in our condensed consolidated financial statements beginning June
16, 2007. Based on consideration of the relevant rights described above, we have
determined that BRC’s 25% equity interest in TAT is not substantive. The amended
arrangement represented, in substance, a research and development arrangement
between us and BRC. Therefore, this arrangement was accounted for as a research
and development arrangement. As of December 31, 2009, all of BRC’s contributions
had been fully expended on research and development activities.
For the three and six months ended June 30, 2010, we incurred related
party research and development costs of $317,000 and $644,000, respectively,
compared to $502,000 and $931,000 for the comparable 2009 periods. As the source
of funds used to perform this research activity on behalf of TAT was derived
from our cash contributions to TAT, no related party revenue has been recognized
for research and development services rendered for TAT for the three and six
months ended June 30, 2010 and 2009.
4. STOCKHOLDERS’ EQUITY
Vendor Stock Issuances
In April 2010, we issued to Girindus America, Inc. (Girindus) 293,225
shares of our common stock in a private placement as consideration for a project
order under a manufacturing agreement pursuant to which Girindus is
manufacturing certain materials for us intended for therapeutic use in humans.
The fair value of the common stock of $1,680,000 was recorded as a prepaid asset
and is being amortized to research and development expense on a pro-rata basis
as services are performed and the proper materials are received. As of June 30,
2010, $1,147,000 remained as a prepaid asset which is expected to be expensed
over the next six months.
In April 2010, we issued to ReSearch Pharmaceutical Services, Inc. (RPS)
259,965 shares of our common stock in a private placement as consideration for a
project agreement under a master services agreement pursuant to which RPS is
providing certain services in support of our clinical programs. The fair value
of the common stock of $1,490,000 was recorded as a prepaid asset and is being
amortized to research and development expense on a pro-rata basis as services
are performed. As of June 30, 2010, $1,062,000 remained as a prepaid asset which
is expected to be expensed over the next six months.
In April 2010, we issued to Prime Synthesis, Inc. (Prime Synthesis)
24,536 shares of our common stock in a private placement as consideration for an
addendum agreement under a master supply agreement pursuant to which Prime
Synthesis is manufacturing certain materials for us intended for therapeutic use
in humans. The fair value of the common stock of $141,000 was recorded as a
prepaid asset and as of June 30, 2010, has been fully amortized to research and
development expense in connection with receipt of the proper
materials.
In April 2010, we issued to Exponent, Inc. (Exponent), the lessor of our
premises at 149 Commonwealth Drive, 93,258 shares of our common stock in a
private placement as a final installment payment of rent due under the extended
lease agreement for the period from May 1, 2010 through July 31, 2012. The fair
value of the common stock of $540,000 has been recorded as a prepaid asset and
is being amortized to rent expense on a pro-rata basis over the lease
term.
15
GERON CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2010
(UNAUDITED)
5. COLLABORATIVE AGREEMENT
In June 2009, we entered into a worldwide exclusive license and alliance
agreement with GE Healthcare UK Limited (GEHC) to develop and commercialize
cellular assay products derived from human embryonic stem cells (hESCs) for use
in drug discovery, development and toxicity screening. Under the terms of the
agreement, GEHC has been granted an exclusive license under Geron’s intellectual
property portfolio covering the growth and differentiation of hESCs, as well as
a sublicense under Geron’s rights to the hESC patents held by the Wisconsin
Alumni Research Foundation. We have established a multi-year alliance program
with GEHC under which scientists from both companies are working to develop
hESC-based products for drug discovery.
In connection with the agreement, we received upfront non-refundable
license payments under the exclusive license and sublicense and can receive
milestone payments upon achievement of certain commercial development and
product sales events and royalties on future product sales. Under the alliance
program, GEHC is responsible for all costs incurred by GEHC and all costs
incurred by Geron for activities undertaken at Geron, including the funding of
Geron scientists working on the alliance program. An Alliance Steering
Committee, with representatives from each company, coordinates and manages the
alliance program.
License payments under the GEHC agreement were recorded as deferred
revenue upon receipt and are being recognized ratably as license fee revenue
over the alliance program period as a result of our continuing involvement in
the collaboration. Funding received for Geron’s efforts under the alliance
program is being recognized as revenue from collaborative agreements as costs
are incurred, which approximates our level of effort over the period of the
alliance program. Since the milestone payments are subject to substantive
contingencies, any such payments will be recognized upon completion of the
specified milestones. Royalties received under the agreement will generally be
recognized as revenue upon receipt of the related royalty payment. For the three
and six months ended June 30, 2010, we recognized $225,000 and $450,000 as
revenue from collaborative agreements, respectively, and $175,000 and $350,000
as license fee revenue, respectively, in connection with this
agreement.
6. SEGMENT INFORMATION
Our executive management team represents our chief decision maker. To
date, we have viewed our operations as one segment, the discovery and
development of therapeutic and diagnostic products for oncology and human
embryonic stem cell therapies. As a result, the financial information disclosed
herein materially represents all of the financial information related to our
principal operating segment.
7. CONDENSED CONSOLIDATED STATEMENTS OF CASH
FLOWS DATA
Supplemental schedule of non-cash
operating and investing activities:
|
|
Six Months Ended |
|
|
June 30, |
(In Thousands) |
|
2010 |
|
2009 |
Supplemental Operating
Activities: |
|
|
|
|
|
|
|
Cash in transit from option
exercises |
|
$ |
— |
|
$ |
33 |
|
Net unrealized gain on investments in
licensees |
|
|
— |
|
|
19 |
|
Reclassification of derivative liabilities to
equity |
|
|
— |
|
|
30 |
|
Issuance of common stock for 401(k) matching
contributions |
|
|
993 |
|
|
665 |
|
Issuance of common stock for services rendered
to date or |
|
|
|
|
|
|
|
to be received in future
periods |
|
|
5,433 |
|
|
3,212 |
|
Reclassification of deposits to other current
assets |
|
|
11 |
|
|
350 |
|
Supplemental Investing Activities: |
|
|
|
|
|
|
|
Net unrealized gain (loss) on marketable
securities |
|
|
138 |
|
|
(89 |
) |
16
GERON CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
JUNE 30, 2010
(UNAUDITED)
8. SUBSEQUENT EVENT
In July 2010, the board of directors and shareholders of TAT approved
actions to commence a voluntary winding up of the company. The remaining assets
of TAT will be fully absorbed by Geron. In connection with the winding up of
TAT, all intellectual property of TAT will be assigned to Geron. BRC will be
entitled to receive royalties on future sales of products covered by the TAT
intellectual property up to an amount equal to 150% of its original capital
contributions to TAT. The full wind up of TAT is expected to conclude by
December 31, 2010.
17
ITEM 2. |
|
MANAGEMENT’S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF
OPERATIONS |
FORWARD-LOOKING STATEMENTS
This Form 10-Q contains forward-looking statements that involve risks and
uncertainties. We use words such as “anticipate”, “believe”, “plan”, “expect”,
“future”, “intend” and similar expressions to identify forward-looking
statements. These statements are within the meaning of the “safe harbor”
provisions of the Private Securities Litigation Reform Act of 1995. These
statements appear throughout the Form 10-Q and are statements regarding our
intent, belief, or current expectations, primarily with respect to our
operations and related industry developments. You should not place undue
reliance on these forward-looking statements, which apply only as of the date of
this Form 10-Q. Our actual results could differ materially from those
anticipated in these forward-looking statements for many reasons, including the
risks faced by us and described in Part II, Item 1A, entitled “Risk Factors” and
in “Management’s Discussion and Analysis of Financial Condition and Results of
Operations” in Part I, Item 2 of this Form 10-Q.
OVERVIEW
The following discussion should be read in conjunction with the unaudited
condensed consolidated financial statements and notes thereto included in Part
I, Item 1 of this Form 10-Q and with Management’s Discussion and Analysis of
Financial Condition and Results of Operations contained in the Company’s Annual
Report on Form 10-K for the fiscal year ended December 31, 2009, as filed with
the Securities and Exchange Commission on February 26, 2010.
Geron is developing first-in-class biopharmaceuticals for the treatment
of cancer and chronic degenerative diseases, including spinal cord injury, heart
failure and diabetes. We are advancing an anti-cancer drug and a cancer vaccine
that target the enzyme telomerase through multiple clinical trials in different
cancers.
Our results of operations have fluctuated from period to period and may
continue to fluctuate in the future, as well as the progress of our research and
development efforts and variations in the level of expenses related to
developmental efforts during any given period. Results of operations for any
period may be unrelated to results of operations for any other period. In
addition, historical results should not be viewed as indicative of future
operating results. We are subject to risks common to companies in our industry
and at our stage of development, including risks inherent in our research and
development efforts, reliance upon our collaborative partners, enforcement of
our patent and proprietary rights, need for future capital, potential
competition and uncertainty of clinical trial results or regulatory approvals or
clearances. In order for a product to be commercialized based on our research,
we and our collaborators must conduct preclinical tests and clinical trials,
demonstrate the efficacy and safety of our product candidates, obtain regulatory
approvals or clearances and enter into manufacturing, distribution and marketing
arrangements, as well as obtain market acceptance. We do not expect to receive
revenues or royalties based on therapeutic products for a period of years, if at
all.
CRITICAL ACCOUNTING POLICIES AND ESTIMATES
We believe that there have been no significant changes in our critical
accounting policies and estimates during the six months ended June 30, 2010 as
compared to the critical accounting policies and estimates disclosed in our
Annual Report on Form 10-K for the year ended December 31, 2009, as filed with
the Securities and Exchange Commission on February 26, 2010.
Our condensed consolidated financial statements have been prepared in
accordance with accounting principles generally accepted in the United States.
The preparation of these financial statements requires management to make
estimates and assumptions that affect the reported assets, liabilities, revenues
and expenses. Note 1 of Notes to Condensed Consolidated Financial Statements
describes the significant accounting policies used in the preparation of the
condensed consolidated financial statements.
18
Estimates and assumptions about future events and their effects cannot be
determined with certainty. We base our estimates on historical experience and on
various other assumptions believed to be applicable and reasonable under the
circumstances. These estimates may change as new events occur, as additional
information is obtained and as our operating environment changes. These changes
have historically been minor and have been included in the condensed
consolidated financial statements as soon as they became known. Based on a
critical assessment of our accounting policies and the underlying judgments and
uncertainties affecting the application of those policies, management believes
that our condensed consolidated financial statements are fairly stated in
accordance with accounting principles generally accepted in the United States,
and present a meaningful presentation of our financial condition and results of
operations.
RESULTS OF OPERATIONS
Revenues
We recognized revenues of $225,000 and $450,000, respectively, from
collaborative agreements for the three and six months ended June 30, 2010,
compared to none for the comparable 2009 periods. Revenues in 2010 reflect
revenue recognized under our collaboration with GE Healthcare UK Limited
(GEHC).
We have entered into license and option agreements with companies
involved in oncology, diagnostics, research tools, agriculture and biologics
production. In each of these agreements, we have granted certain rights to our
technologies. In connection with the agreements, we are entitled to receive
license fees, option fees, milestone payments and royalties on future sales, or
any combination thereof. We recognized license fee revenues of $302,000 and
$907,000 for the three and six months ended June 30, 2010, respectively,
compared to $145,000 and $526,000 for the comparable 2009 periods related to our
various agreements. The increase in license fees for the 2010 periods compared
to the 2009 periods primarily reflected revenue recognized from upfront license
fee payments under our worldwide exclusive license agreement with GEHC
effective June 2009. We expect to recognize revenues of $350,000 for the
remainder of 2010, $350,000 in 2011 and no revenues thereafter related to our
existing deferred revenue. Current revenues may not be predictive of future
revenues.
We received royalties of $474,000 and $562,000 for the three and six
months ended June 30, 2010, respectively, compared to $38,000 and $101,000 for
the comparable 2009 periods on product sales of telomerase detection and
telomere measurement kits to the research-use-only market, cell-based research
products and agricultural products. License and royalty revenues are dependent
upon additional agreements being signed and future product sales.
Research and Development
Expenses
Research and development expenses were $13.4 million and $26.9 million
for the three and six months ended June 30, 2010, respectively, compared to
$15.1 million and $28.9 million for the comparable 2009 periods. The decrease in
research and development expenses for the three and six months ended June 30,
2010 compared to the comparable 2009 periods was primarily due to reduced
product manufacturing costs resulting from completion of patient enrollment in
our Phase II trial of GRNVAC1 of $806,000 and $1.5 million, respectively, and
lower preclinical study costs of $612,000 and $497,000, respectively. Overall,
we expect research and development expenses to increase as we incur expenses
related to Phase II clinical trials for imetelstat along with continued
development of our human embryonic stem cell (hESC) programs.
19
Our research and development activities have arisen from our two major
technology platforms, telomerase and hESCs. The oncology programs focus on
treating or diagnosing cancer by targeting or detecting the presence of
telomerase, either inhibiting activity of the telomerase enzyme, diagnosing
cancer by detecting the presence of telomerase, or using telomerase as a target
for therapeutic vaccines. Our core knowledge base in telomerase and telomere
biology supports all these approaches, and our scientists may contribute to any
or all of these programs in a given period. The following table gives the status
of our oncology clinical trials:
|
|
|
|
|
|
|
|
|
Patient |
|
|
|
|
Product |
|
|
|
Development |
|
Enrollment |
|
|
Product |
|
Description |
|
Application |
|
Stage |
|
Status |
|
|
Imetelstat |
|
Telomerase |
|
Chronic Lymphoproliferative |
|
Phase I Trial |
|
Completed |
|
|
(GRN163L) |
|
Inhibitor |
|
Diseases |
|
(single agent) |
|
|
|
|
Imetelstat |
|
Telomerase |
|
Solid Tumors |
|
Phase I Trial |
|
Open |
|
|
(GRN163L) |
|
Inhibitor |
|
|
|
(single
agent) |
|
|
|
|
Imetelstat |
|
Telomerase |
|
Multiple Myeloma* |
|
Phase I Trial |
|
Completed |
|
|
(GRN163L) |
|
Inhibitor |
|
|
|
(single agent) |
|
|
|
|
Imetelstat |
|
Telomerase |
|
Non-Small Cell Lung |
|
Phase I Trial |
|
Completed |
|
|
(GRN163L) |
|
Inhibitor |
|
Cancer* |
|
(combination) |
|
|
|
|
Imetelstat |
|
Telomerase |
|
Breast Cancer* |
|
Phase I/II Trial |
|
Open |
|
|
(GRN163L) |
|
Inhibitor |
|
|
|
(combination) |
|
|
|
|
Imetelstat |
|
Telomerase |
|
Multiple Myeloma |
|
Phase I Trial |
|
Completed |
|
|
(GRN163L) |
|
Inhibitor |
|
|
|
(combination) |
|
|
|
|
GRNVAC1 |
|
Telomerase |
|
Acute Myelogenous |
|
Phase II Trial |
|
Completed |
|
|
|
|
Cancer
Vaccine |
|
Leukemia (AML) |
|
|
|
|
|
|
*
Initiation of Phase II clinical trials in non-small cell lung cancer,
multiple myeloma, breast cancer and essential thrombocythemia is planned
for 2010. |
|
Interim data from the Phase I single agent trial in patients with
relapsed and refractory multiple myeloma has shown that imetelstat inhibits
telomerase both in the bulk myeloma fraction as well as the stem-cell containing
fraction in patients’ bone marrow. Interim data from the trial in patients with
refractory, advanced solid cancers has shown that with a modified dosing
schedule, the exposures to imetelstat exceeded the levels associated with
inhibiting tumor growth from several models of human cancers. From the above
trials, we have obtained data to assess the safety, tolerability,
pharmacokinetics and pharmacodynamics of imetelstat. With this information, we
have established the single agent Phase II dose and dosing schedule and are
planning to advance imetelstat to Phase II clinical trials in four different
malignancies. In July 2010, the first patient was enrolled into Geron’s
randomized Phase II clinical trial of imetelstat as maintenance therapy
following platinum-based induction therapy for patients with non-small cell lung
cancer.
Taking the results from the Duke University clinical studies in prostate
cancer, hematologic malignancies and renal cell carcinoma, we optimized the
vaccine manufacturing process and transferred it to a contract manufacturer. We
are conducting a Phase II clinical trial of our telomerase vaccine using the
prime/boost vaccination protocol in patients with acute myelogenous leukemia in
complete clinical remission. Recent data from the trial showed that GRNVAC1 was
safe and generally well tolerated over multiple vaccinations. Continued
follow-up of patients for an additional six months is required to estimate the
impact of vaccination on disease-free survival.
Our hESC therapy programs focus on treating injuries and degenerative
diseases with cell therapies based on cells derived from hESCs. Core knowledge
of hESC biology, as well as a significant continuing effort in deriving,
growing, maintaining, and differentiating hESCs, underlies all aspects of this
group of programs. Many of our researchers are allocated to more than one hESC
program, and the percentage allocations of time change as the resource needs of
individual programs vary. In our hESC therapy programs, we have concentrated our
resources on several specific cell types, including:
- GRNOPC1, hESC-derived
oligodendrocyte progenitor cells, for the treatment of acute spinal cord
injury;
- GRNCM1, hESC-derived
cardiomyocytes, for toxicology drug testing and the treatment of myocardial
disease;
- GRNIC1, hESC-derived pancreatic
islet ß cells for the treatment of diabetes;
- GRNCHND1, hESC-derived
chondrocytes for the treatment of osteoarthritis;
- hESC-derived hepatocytes for ADME
drug testing;
- hESC-derived dendritic cells for
cancer immunotherapy and to prevent immune rejection of the other cell types
used in therapeutic applications; and
- hESC-derived osteoblasts for the
treatment of osteoporosis and non-union bone fractures.
20
We have developed proprietary methods to grow, maintain, and scale the
culture of undifferentiated hESCs that use feeder cell-free and serum-free media
with chemically defined components. We have also developed scalable processes to
differentiate these cells into therapeutically relevant cells. Recently, the
U.S. Food and Drug Administration (FDA) lifted its clinical hold on the
Investigational New Drug (IND) application for GRNOPC1, our human embryonic stem
cell (hESC)-derived therapy targeted for the treatment of acute spinal cord
injury. We will proceed with initiation of the Phase I multi-center trial that
is designed to establish the safety of GRNOPC1 in patients with “complete”
American Spinal Injury Association (ASIA) grade A subacute thoracic spinal cord
injuries.
Research and development expenses allocated to programs are as follows
(in thousands):
|
Three Months Ended |
|
Six Months Ended |
|
June 30, |
|
June 30, |
|
2010 |
|
2009 |
|
2010 |
|
2009 |
|
(Unaudited) |
Oncology |
$
|
6,618 |
|
$
|
7,691 |
|
$
|
12,789 |
|
$
|
15,020 |
hESC Therapies |
|
6,771 |
|
|
7,421 |
|
|
14,145 |
|
|
13,863 |
Total |
$ |
13,389 |
|
$ |
15,112 |
|
$ |
26,934 |
|
$ |
28,883 |
|
|
|
|
|
|
|
|
|
|
|
|
At this time, we cannot provide reliable estimates of how much time or
investment will be necessary to commercialize products from the programs
currently in progress. Drug development in the United States is a process that
includes multiple steps defined by the FDA under applicable statutes,
regulations and guidance documents. After the preclinical research process of
identifying, selecting and testing in animals a potential pharmaceutical
compound, the clinical development process begins with the filing of an
Investigational New Drug (IND) application. Clinical development typically
involves three phases of trials: Phase I, II and III. The most significant costs
associated with clinical development are incurred in Phase III trials, which
tend to be the longest and largest studies conducted during the drug development
process. After the completion of a successful preclinical and clinical
development program, a New Drug Application (NDA) or Biologics License
Application (BLA) must be filed with the FDA, which includes, among other
things, very large amounts of preclinical and clinical data and results and
manufacturing-related information necessary to support requested approval of the
product. The NDA/BLA must be reviewed and approved by the FDA.
According to industry statistics, it generally takes 10 to 15 years to
research, develop and bring to market a new prescription medicine in the United
States. In light of the steps and complexities involved, the successful
development of our potential products is highly uncertain. Actual timelines and
costs to develop and commercialize a product are subject to enormous variability
and are very difficult to predict. In addition, various statutes and regulations
also govern or influence the manufacturing, safety reporting, labeling, storage,
record keeping and marketing of each product.
The lengthy process of seeking these regulatory reviews and approvals,
and the subsequent compliance with applicable statutes and regulations, require
the expenditure of substantial resources. Any failure by us to obtain, or any
delay in obtaining, regulatory approvals could materially adversely affect our
business. In responding to an NDA/BLA submission, the FDA may grant marketing
approval, may request additional information, may deny the application if it
determines that the application does not provide an adequate basis for approval,
and may also refuse to review an application that has been submitted if it
determines that the application does not provide an adequate basis for filing
and review. We cannot provide assurance that any approval required by the FDA
will be obtained on a timely basis, if at all.
For a more complete discussion of the risks and uncertainties associated
with completing development of potential products, see the sub-section titled
“Delays in the commencement of clinical testing of our current and potential
product candidates could result in increased costs to us and delay our ability
to generate revenues” and
“Obtaining regulatory approvals to market our product candidates in the United
States and other countries is a costly and lengthy process and we cannot predict
whether or when we will be permitted to commercialize our product candidates” in
Part II, Item 1A entitled “Risk Factors” and elsewhere in this quarterly
report.
21
General and Administrative
Expenses
General and administrative expenses were $4.5 million and $8.3 million
for the three and six months ended June 30, 2010, respectively, compared to $3.8
million and $7.2 million for the comparable 2009 periods. The increase in
general and administrative expenses for the three and six months ended June 30,
2010 compared to the comparable 2009 periods was primarily due to higher
non-cash compensation expense associated with equity-based awards of $494,000
and $622,000, respectively, and higher consulting costs of $323,000 and
$434,000, respectively. We currently anticipate general and administrative
expenses to remain consistent with current levels.
Unrealized Gain (Loss) on
Derivatives
Unrealized gain (loss) on derivatives reflects a non-cash adjustment for
changes in fair value of warrants to purchase common stock and options held by
non-employees that are classified as current liabilities. Derivatives classified
as assets or liabilities are marked to fair value at each financial reporting
date with any resulting unrealized gain (loss) recorded in the condensed
consolidated statements of operations. The derivatives continue to be reported
as an asset or liability until such time as the instruments are exercised or
expire or are otherwise modified to remove the provisions which require them to
be recorded as assets or liabilities, at which time these instruments are marked
to fair value and reclassified from assets or liabilities to stockholders’
equity. We incurred unrealized gains on derivatives of $172,000 and $230,000 for
the three and six months ended June 30, 2010, respectively, compared to
unrealized losses of $1.3 million for the comparable 2009 periods. The
unrealized gains on derivatives for 2010 primarily reflected reduced fair values
of derivative liabilities resulting from shortening of their contractual terms
and changes in other inputs factored into the estimate of their fair value such
as the volatility of our common stock. The unrealized losses on derivatives for
2009 primarily reflected increased fair values of derivative liabilities
resulting from higher underlying common stock values.
Interest and Other Income
Interest income was $194,000 and $396,000 for the three and six months
ended June 30, 2010, respectively, compared to $363,000 and $888,000 for the
comparable 2009 periods. The decrease in interest income for the 2010 periods
compared to the 2009 periods was primarily due to lower interest rates and lower
cash and investment balances. Interest earned in future periods will depend on
the size of our securities portfolio and prevailing interest rates.
Losses Recognized Under Equity Method
Investment
We own 28% of ViaGen, Inc. (ViaGen), a licensee with in-house breeding
services and expertise in advanced reproductive technologies for animal cloning.
In accordance with the equity method of accounting, we recognized losses of
$496,000 and $892,000 for the three and six months ended June 30, 2010,
respectively, compared to none and $656,000 for the comparable 2009 periods for
our proportionate share of ViaGen’s losses.
Interest and Other Expense
Interest and other expense was $25,000 and $52,000 for the three and six
months ended June 30, 2010, respectively, compared to $34,000 and $86,000 for
the comparable 2009 periods. The decrease in interest and other expense for the
2010 periods compared to the 2009 periods was primarily due to lower investment
management charges.
22
Deemed Dividend on
Derivatives
In April 2009, we modified the terms of certain outstanding warrants held
by an investor by extending the exercise term and for certain of these warrants,
reducing the exercise price. In connection with the modifications, we recognized
a deemed dividend of approximately $190,000 for the incremental fair value of
the modified warrants, as calculated using the Black Scholes option-pricing
model as of the modification date.
Net Loss Applicable to Common Stockholders
Net loss applicable to common stockholders was $17.0 million and $33.7
million for the three and six months ended June 30, 2010, respectively, compared
to $19.9 million and $36.8 million for the comparable 2009 periods. The decrease
in net loss applicable to common stockholders for the 2010 periods compared to
the 2009 periods was primarily the net result of increased revenues under our
license and collaboration with GEHC, reduced research and development expenses
and unrealized gains on derivatives, partially offset by decreased interest
income due to lower interest rates and lower cash and investment
balances.
LIQUIDITY AND CAPITAL
RESOURCES
Cash, restricted cash, cash equivalents and marketable securities at June
30, 2010 were $156.0 million, compared to $167.1 million at December 31, 2009.
We have an investment policy to invest these funds in liquid, investment grade
securities, such as interest-bearing money market funds, municipal securities,
U.S. government and agency securities, corporate notes, commercial paper and
asset-backed securities. Our investment portfolio does not contain securities
with exposure to sub-prime mortgages, collateralized debt obligations or auction
rate securities and to date we have not recognized an other-than-temporary
impairment on our marketable securities or any significant changes in aggregate
fair value that would impact our cash resources or liquidity. To date, we have
not experienced lack of access to our invested cash and cash equivalents;
however, we cannot provide assurances that access to our invested cash and cash
equivalents will not be impacted by adverse conditions in the financial markets.
The decrease in cash, restricted cash, cash equivalents and marketable
securities in 2010 was the net result of use of cash for operations, partially
offset by the receipt of $10.0 million in gross proceeds from the sale of shares
of common stock and warrants to purchase additional shares of common stock to
institutional investors in January 2010.
We estimate that our existing capital resources, interest income and
equipment financing facility will be sufficient to fund our current level of
operations through at least December 2011. However, our future capital
requirements will be substantial. Changes in our research and development plans
or other changes affecting our operating expenses or cash balances may result in
the expenditure of available resources before such time. Factors that may
require us to use our available capital resources sooner than we anticipate
include:
- continued clinical development of
our product candidates, imetelstat, GRNVAC1 and GRNOPC1;
- our ability to meaningfully reduce
manufacturing costs of current product candidates;
- future clinical trial
results;
- progress of product and
preclinical development of our other product candidates, such as GRNCM1,
GRNIC1 and GRNCHND1;
- cost and timing of regulatory
approvals; and
- filing, maintenance, prosecution,
defense and enforcement of patent claims and other intellectual property
rights.
If our capital resources are insufficient to meet future capital
requirements, we will need to raise additional capital to fund our operations.
We intend to seek additional funding through strategic collaborations, public or
private equity financings, equipment loans or other financing sources that may
be available. However, we may be unable to raise sufficient additional capital
when we need it, on favorable terms or at all. If we are unable to obtain adequate funds on reasonable
terms, we may be required to curtail operations significantly or obtain funds by
entering into financing, supply or collaboration agreements on unattractive
terms or we may be required to relinquish rights to technology or product
candidates or to grant licenses on terms that are unfavorable to
us.
23
Cash Flows from Operating Activities. Net cash used in operations for the six months
ended June 30, 2010 and 2009 was $19.2 million and $20.5 million, respectively.
The decrease in net cash used for operations in 2010 was primarily the result of
increased revenues from our collaboration with GEHC and higher royalty
revenues.
Cash Flows from Investing Activities. Net cash provided by investing activities was
$11.7 million for the six months ended June 30, 2010. Net cash used in investing
activities was $34.5 million for the six months ended June 30, 2009. The
decrease in net cash used in investing activities reflected decreased purchases
of marketable securities and increased maturities of marketable
securities.
As of June 30, 2010 we had approximately $500,000 available for borrowing
under our equipment financing facility. We renewed the commitment for this
equipment financing facility in 2009 to further fund equipment purchases. If we
are unable to renew the commitment in the future, we will use our cash resources
for capital expenditures.
Cash Flows from Financing Activities. Net cash provided by financing activities was
$10.2 million and $47.0 million for the six months ended June 30, 2010 and 2009,
respectively. In January 2010, we exchanged outstanding warrants held by certain
institutional investors for shares of our common stock. In connection with the
warrant exchange, we sold 1,481,481 shares of our common stock and warrants to
purchase an additional 740,741 shares of common stock to the investors for gross
proceeds of $10.0 million. In February 2009, we completed a public offering of
7,250,000 shares of our common stock at a public offering price of $6.60 per
share, resulting in net proceeds of approximately $45.9 million after deducting
underwriting discounts and commissions and offering expenses.
Contractual Obligations
As of June 30, 2010, our contractual obligations for the next five years
and thereafter were as follows:
|
|
Principal Payments Due by
Period |
|
|
|
|
|
Remainder |
|
2011- |
|
2013- |
|
After |
Contractual Obligations
(1) |
|
Total |
|
in 2010 |
|
2012 |
|
2014 |
|
2014 |
|
|
(Amounts in
thousands) |
Equipment leases |
|
$
|
34 |
|
$
|
7 |
|
$
|
25 |
|
$
|
2 |
|
$
|
— |
Operating leases (2) |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
Research funding (3) |
|
|
1,637 |
|
|
329 |
|
|
399 |
|
|
384 |
|
|
525 |
Total contractual cash obligations |
|
$ |
1,671 |
|
$ |
336 |
|
$ |
424 |
|
$ |
386 |
|
$ |
525 |
____________________ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
This
table does not include any milestone payments under research
collaborations or license agreements as the timing and likelihood of such
payments are not known. In addition, this table does not include payments
under our severance plan in the event of a change in control of the
company or severance payments to key employees under involuntary
termination. |
|
(2) |
|
In
March 2008, we issued 742,158 shares of our common stock to the lessor of
our premises at 200 and 230 Constitution Drive in payment of our monthly
rental obligation from August 1, 2008 through July 31, 2012. In May 2007,
we issued 210,569 shares of our common stock to the lessor of our premises
at 149 Commonwealth Drive in payment of our monthly rental obligation from
May 1, 2007 through April 30, 2010. In January 2010, we extended the lease
at our premises at 149 Commonwealth Drive. In January 2010 and April 2010,
we issued an aggregate of 187,999 shares of our common stock to the lessor
of those premises in payment of our monthly rental obligation from May 1,
2010 through July 31, 2012. The fair value of the common stock issuances
has been recorded as a prepaid asset and is being amortized to rent
expense on a straight-line basis over the lease periods. Future minimum
payments under non-cancelable operating leases are zero through July 31,
2012, as a result of the prepayments of rent with our common
stock. |
|
(3) |
|
Research funding is comprised of sponsored research and license
commitments at various laboratories around the
world. |
24
Off-Balance Sheet Arrangements
None.
ITEM 3. QUANTITATIVE AND QUALITATIVE
DISCLOSURES ABOUT MARKET RISK
The following discussion about our market risk disclosures contains
forward-looking statements. Actual results could differ materially from those
projected in the forward-looking statements. We are exposed to market risk
related to changes in interest rates and foreign currency exchange rates. We do
not use derivative financial instruments for speculative or trading
purposes.
Credit Risk. We
place our cash, restricted cash, cash equivalents and marketable securities with
six financial institutions in the United States and Scotland. Deposits with
banks may exceed the amount of insurance provided on such deposits. While we
monitor the cash balances in our operating accounts and adjust the cash balances
as appropriate, these cash balances could be impacted if the underlying
financial institutions fail or could be subject to other adverse conditions in
the financial markets. Financial instruments that potentially subject us to
concentrations of credit risk consist primarily of cash equivalents and
marketable securities. Cash equivalents and marketable securities currently
consist of money market funds, municipal securities, U.S. government-sponsored
enterprise securities, commercial paper and corporate notes. Our investment
policy, approved by our Board of Directors, limits the amount we may invest in
any one type of investment issuer, thereby reducing credit risk concentrations.
We limit our credit and liquidity risks through our investment policy and
through regular reviews of our portfolio against our policy. To date, we have
not experienced any loss or lack of access to cash in our operating accounts or
to our cash equivalents and marketable securities in our investment
portfolios.
Interest Rate Sensitivity. The primary objective of our investment activities is to manage our
marketable securities portfolio to preserve principal and liquidity while
maximizing the return on the investment portfolio through the full investment of
available funds without significantly increasing risk. To achieve this
objective, we invest in widely diversified investments consisting of both fixed
rate and floating rate interest earning instruments, and both carry a degree of
interest rate risk. Fixed rate securities may have their fair value adversely
impacted due to a rise in interest rates, while floating rate securities may
produce less income than expected if interest rates fall. Due in part to these
factors, our future interest income may fall short of expectations due to
changes in market conditions and in interest rates or we may suffer losses in
principal if forced to sell securities which may have declined in fair value due
to changes in interest rates.
The fair value of our cash equivalents and marketable securities at June
30, 2010 was $153.9 million. These investments include $36.0 million of cash
equivalents which are due in less than 90 days, $83.8 million of short-term
investments which are due in less than one year and $34.1 million of long-term
investments which are due in one to two years. We primarily invest our
marketable securities portfolio in securities with at least an investment grade
rating to minimize interest rate and credit risk as well as to provide for an
immediate source of funds. Although changes in interest rates may affect the
fair value of the marketable securities portfolio and cause unrealized gains or
losses, such gains or losses would not be realized unless the investments are
sold. Due to the nature of our investments, which are primarily money market
funds, municipal securities, U.S. government-sponsored enterprise securities,
commercial paper and corporate notes, we have concluded that there is no
material market risk exposure.
Foreign Currency Exchange Risk. Because we translate foreign currencies into
U.S. dollars for reporting purposes, currency fluctuations can have an impact,
though generally immaterial, on our operating results. We believe that our
exposure to currency exchange fluctuation risk is insignificant primarily
because our wholly-owned international subsidiary, Geron Bio-Med Ltd., satisfies
its financial obligations almost exclusively in its local currency. As of June 30, 2010, there was an
immaterial currency exchange impact from our intercompany transactions. As of
June 30, 2010, we did not engage in foreign currency hedging
activities.
25
ITEM 4. CONTROLS AND
PROCEDURES
(a) Evaluation of Disclosure Controls and
Procedures. The Securities
and Exchange Commission defines the term “disclosure controls and procedures” to
mean a company’s controls and other procedures that are designed to ensure that
information required to be disclosed in the reports that it files or submits
under the Securities Exchange Act of 1934, as amended, is recorded, processed,
summarized and reported, within the time periods specified in the Securities and
Exchange Commission’s rules and forms. Our Chief Executive Officer and our Chief
Financial Officer have concluded, based on the evaluation of the effectiveness
of our disclosure controls and procedures by our management, with the
participation of our Chief Executive Officer and our Chief Financial Officer, as
of the end of the period covered by this report, that our disclosure controls
and procedures were effective for this purpose.
(b) Changes in Internal Controls Over Financial
Reporting. There was no
change in our internal control over financial reporting for the three months
ended June 30, 2010 that has materially affected, or is reasonably likely to
materially affect, our internal control over financial reporting.
It should be noted that any system of controls, however well designed and
operated, can provide only reasonable assurance, and not absolute assurance,
that the objectives of the system are met. In addition, the design of any
control system is based in part upon certain assumptions about the likelihood of
future events. Because of these and other inherent limitations of control
systems, there can be no assurance that any design will succeed in achieving its
stated goals in all future circumstances.
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
None.
ITEM 1A. RISK FACTORS
Our business is subject to various risks, including those described
below. You should carefully consider these risk factors, together with all of
the other information included in this Form 10-Q. Any of these risks could
materially adversely affect our business, operating results and financial
condition.
RISKS RELATED TO OUR BUSINESS
Our business is at an early stage of development.
Our business is at an early stage of development, in that we do not yet
have product candidates in late-stage clinical trials or on the market. We have
sponsored six Phase I or I/II trials of our lead anti-cancer drug, imetelstat,
in patients with chronic lymphoproliferative diseases, solid tumor malignancies,
non-small cell lung cancer, breast cancer and multiple myeloma. Four of those
trials have completed patient enrollment and the remaining two are expected to
complete enrollment in 2010. We currently plan to advance imetelstat to Phase II
trials in 2010 in four different malignancies. In July 2010, the first patient
was enrolled into Geron’s randomized Phase II clinical trial of imetelstat
as maintenance therapy following platinum-based induction therapy for patients
with non-small cell lung cancer. Patient enrollment for our telomerase cancer
vaccine, GRNVAC1, trial in patients with acute myelogenous leukemia is now
complete and we are awaiting the results from this Phase II trial. We have no
other product candidates in clinical testing. Recently, the U.S. Food and Drug
Administration (FDA) lifted its clinical hold on the Investigational New Drug
(IND) application for GRNOPC1, our human embryonic stem cell (hESC)-derived
therapy targeted for the treatment of acute spinal cord injury. We will proceed
with initiation of the Phase I multi-center trial that is designed to establish the safety of GRNOPC1 in
patients with “complete” American Spinal Injury Association (ASIA) grade A
subacute thoracic spinal cord injuries.
26
Our ability to develop product candidates that progress to and through
clinical trials is subject to our ability to, among other things:
- succeed in our research and
development efforts;
- select therapeutic compounds or
cell therapies for development;
- obtain required regulatory
approvals;
- manufacture product candidates;
and
- collaborate successfully with
clinical trial sites, academic institutions, physician investigators, clinical
research organizations and other third parties.
Potential lead drug compounds or other product candidates and
technologies require significant preclinical and clinical testing prior to
regulatory approval in the United States and other countries. Our product
candidates may prove to have undesirable and unintended side effects or other
characteristics adversely affecting their safety, efficacy or cost-effectiveness
that could prevent or limit their commercial use. In addition, our product
candidates may not prove to be more effective for treating disease or injury
than current therapies. Accordingly, we may have to delay or abandon efforts to
research, develop or obtain regulatory approvals to market our product
candidates. In addition, we will need to determine whether any of our potential
products can be manufactured in commercial quantities at an acceptable cost. Our
research and development efforts may not result in a product that can be or will
be approved by regulators or marketed successfully. Competitors may have
proprietary rights which prevent us from developing and marketing our products
or they may sell similar, superior or lower-cost products. Because of the
significant scientific, regulatory and commercial milestones that must be
reached for any of our development programs or product candidates to be
successful, any program or product candidate may be abandoned, even after we
have expended significant resources, such as our investments in telomerase
technology, hESCs, imetelstat, GRNVAC1 and GRNOPC1, which could adversely affect
our business and cause a sharp drop in our stock price.
The science and technology of telomere biology and telomerase and hESCs
are relatively new. There is no precedent for the successful commercialization
of therapeutic product candidates based on our technologies. These development
programs are therefore particularly risky. In addition, we, our licensees or our
collaborators must undertake significant research and development activities to
develop product candidates based on our technologies, which will require
additional funding and may take years to accomplish, if ever.
Restrictions on the use of hESCs, political commentary and the ethical
and social implications of research involving hESCs could prevent us from
developing or gaining acceptance for commercially viable products based upon
such stem cells and adversely affect the market price of our common stock.
Some of our most important programs involve the use of stem cells that
are derived from human embryos. The use of hESCs gives rise to ethical and
social issues regarding the appropriate use of these cells. Our research related
to hESCs may become the subject of adverse commentary or publicity, which could
significantly harm the market price for our common stock.
Some political and religious groups have voiced opposition to our
technology and practices. We use stem cells derived from human embryos that had
been created for in vitro fertilization procedures but were no longer
desired or suitable for that use and were donated with appropriate informed
consent. Many research institutions, including some of our scientific
collaborators, have adopted policies regarding the ethical use of human
embryonic tissue. These policies may have the effect of limiting the scope of
research conducted using hESCs, thereby impairing our ability to conduct
research in this field.
27
On March 9, 2009, President Obama issued Executive Order 13505, entitled
“Removing Barriers to Responsible Scientific Research Involving Human Stem
Cells.” As a result, in July 2009 the Secretary of Health and Human Services, through the
Director of the National Institutes of Health (NIH), issued new guidelines
relating to human stem cell research. Under the new guidelines, federal funding
is allowed for research using hESCs derived from embryos created by in vitro
fertilization for reproductive purposes, but are no longer needed for that
purpose. Strict ethics requirements must be followed to qualify new stem cell
lines, including extensive documentation around consent forms and written
policies and procedures. Certain states are considering enacting, or already
have enacted, legislation relating to stem cell research, including California,
whose voters approved Proposition 71 to provide state funds for stem cell
research in November 2004. In the United Kingdom and other countries, the use of
embryonic or fetal tissue in research (including the derivation of hESCs) is
regulated by the government, whether or not the research involves government
funding.
Government-imposed restrictions with respect to use of embryos or hESCs
in research and development could have a material adverse effect on us,
including:
- harming our ability to establish
critical partnerships and collaborations;
- delaying or preventing progress in
our research, product development or clinical testing;
- preventing commercialization of
therapies derived from hESCs; and
- as a result of the potential
adverse effects above, causing a decrease in the price of our common
stock.
RISKS RELATED TO OUR FINANCIAL POSITION AND
NEED FOR ADDITIONAL FINANCING
We have a history of losses and anticipate future losses, and continued
losses could impair our ability to sustain operations.
We have incurred operating losses every year since our operations began
in 1990. As of June 30, 2010, our accumulated deficit was approximately $610.9
million. Losses have resulted principally from costs incurred in connection with
our research and development activities and from general and administrative
costs associated with our operations. We expect to incur additional operating
losses and, as our development efforts and clinical testing activities continue,
our operating losses may increase in size.
Substantially all of our revenues to date have been research support
payments under collaboration agreements and revenues from our licensing
arrangements. We may be unsuccessful in entering into any new corporate
collaboration or license agreement that results in revenues. We do not expect
that the revenues generated from these arrangements will be sufficient alone to
continue or expand our research or development activities and otherwise sustain
our operations.
While we receive royalty revenue from licenses, we do not currently
expect to receive sufficient royalty revenues from these licenses to
independently sustain our operations. Our ability to continue or expand our
research and development activities and otherwise sustain our operations is
dependent on our ability, alone or with others, to, among other things,
manufacture and market therapeutic products.
We also expect to experience negative cash flow for the foreseeable
future as we fund our operating losses and capital expenditures. This will
result in decreases in our working capital, total assets and stockholders’
equity, which may not be offset by future financings. We will need to generate
significant revenues to achieve profitability. We may not be able to generate
these revenues, and we may never achieve profitability. Our failure to achieve
profitability could negatively impact the market price of our common stock. Even
if we do become profitable, we cannot assure you that we would be able to
sustain or increase profitability on a quarterly or annual basis.
28
We will need additional capital to conduct our operations and develop our
product candidates, and our ability to obtain the necessary funding is
uncertain.
We will require substantial capital resources in order to conduct our
operations and develop our product candidates, and we cannot assure you that our
existing capital resources, interest income and equipment financing arrangement
will be sufficient to fund future planned operations. The timing and degree of
any future capital requirements will depend on many factors,
including:
- the accuracy of the assumptions
underlying our estimates for our capital needs for the 2010 fiscal year and
beyond;
- the magnitude and scope of our
research and development programs;
- the progress we make in our
research and development programs, preclinical development and clinical
trials;
- our ability to establish, enforce
and maintain strategic arrangements for research, development, clinical
testing, manufacturing and marketing;
- the number and type of product
candidates that we pursue;
- the time and costs involved in
obtaining regulatory approvals and clearances; and
- the costs involved in preparing,
filing, prosecuting, maintaining, defending and enforcing patent
claims.
We do not have any committed sources of capital. Additional financing
through strategic collaborations, public or private equity financings, capital
lease transactions or other financing sources may not be available on acceptable
terms, or at all. The receptivity of the public and private equity markets to
proposed financings is substantially affected by the general economic, market
and political climate and by other factors which are unpredictable and over
which we have no control. Additional equity financings, if we obtain them, could
result in significant dilution to stockholders. Further, in the event that
additional funds are obtained through arrangements with collaborative partners,
these arrangements may require us to relinquish rights to some of our
technologies, product candidates or proposed products that we would otherwise
seek to develop and commercialize ourselves. If sufficient capital is not
available, we may be required to delay, reduce the scope of or eliminate one or
more of our programs, any of which could have a material adverse effect on our
business.
RISKS RELATED TO CLINICAL AND
COMMERCIALIZATION ACTIVITIES
Delays in the commencement of clinical testing of our current and
potential product candidates could result in increased costs to us and delay our
ability to generate revenues.
The commencement of clinical trials can be delayed for a variety of
reasons, including delays in:
- demonstrating sufficient safety
and efficacy to obtain regulatory clearance to commence a clinical
trial;
- manufacturing sufficient
quantities or producing drugs meeting our quality standards of a product
candidate;
- obtaining approval of an
Investigational New Drug (IND) application or proposed trial design from the
FDA;
- reaching agreement on acceptable
terms with our collaborators on all aspects of the clinical trial, including
the contract research organizations (CROs) and the trial sites;
and
- obtaining institutional review
board approval to conduct a clinical trial at a prospective site.
In addition, clinical trials may be delayed due to insufficient patient
enrollment, which is a function of many factors, including the size and nature
of the patient population, the nature of the protocol, the proximity of patients
to clinical sites, the availability of effective treatments for the relevant
disease, and the eligibility criteria for the clinical trial. Delays in
commencing clinical testing of our product candidates could have a material
adverse effect on our business.
29
We do not have experience as a company in conducting large-scale clinical
trials, or in other areas required for the successful commercialization and
marketing of our product candidates.
We have no experience as a company in conducting large-scale, late stage
clinical trials. We cannot be certain that planned clinical trials will begin or
be completed on time, if at all. Large-scale trials would require either
additional financial and management resources, or reliance on third-party
clinical investigators, CROs or consultants. Relying on third-party clinical
investigators or CROs may force us to encounter delays that are outside of our
control. Any such delays could have a material adverse effect on our
business.
We also do not currently have marketing and distribution capabilities for
our product candidates. Developing an internal sales and distribution capability
would be an expensive and time-consuming process. We may enter into agreements
with third parties that would be responsible for marketing and distribution.
However, these third parties may not be capable of successfully selling any of
our product candidates. The inability to commercialize and market our product
candidates could materially adversely affect our business.
Obtaining regulatory approvals to market our product candidates in the
United States and other countries is a costly and lengthy process and we cannot
predict whether or when we will be permitted to commercialize our product
candidates.
Federal, state and local governments in the United States and governments
in other countries have significant regulations in place that govern many of our
activities and may prevent us from creating commercially viable products from
our discoveries. The regulatory process, particularly for biopharmaceutical
product candidates like ours, is uncertain, can take many years and requires the
expenditure of substantial resources.
Our potential product candidates will require extensive preclinical and
clinical testing prior to submission of any regulatory application to commence
commercial sales. In particular, human pharmaceutical therapeutic product
candidates are subject to rigorous requirements of the FDA in the United States
and similar health authorities in other countries in order to demonstrate safety
and efficacy. Data obtained from preclinical and clinical activities is
susceptible to varying interpretations that could delay, limit or prevent
regulatory agency approvals. In addition, delays or rejections may be
encountered as a result of changes in regulatory agency policy during the period
of product development and/or the period of review of any application for
regulatory agency approval for a product candidate.
Any product candidate that we or our collaborators develop must receive
all relevant regulatory agency approvals before it may be marketed in the United
States or other countries. Obtaining regulatory approval is a lengthy, expensive
and uncertain process. Because certain of our product candidates involve the
application of new technologies or are based upon a new therapeutic approach,
they may be subject to substantial additional review by various government
regulatory authorities, and, as a result, the process of obtaining regulatory
approvals for them may proceed more slowly than for product candidates based
upon more conventional technologies.
Delays in obtaining regulatory
agency approvals could:
- significantly harm the marketing
of any products that we or our collaborators develop;
- impose costly procedures upon our
activities or the activities of our collaborators;
- diminish any competitive
advantages that we or our collaborators may attain; or
- adversely affect our ability to
receive royalties and generate revenues and profits.
Even if we commit the
necessary time and resources, the required regulatory agency approvals may not
be obtained for any product candidates developed by us or in collaboration with
us. If we obtain regulatory agency approval for a new product, this approval may
entail limitations on the indicated uses for which it can be marketed that could
limit the potential commercial use of the product.
30
Failure to achieve continued compliance with government regulation over
approved products could delay or halt commercialization of our
products.
Approved products and their manufacturers are subject to continual
review, and discovery of previously unknown problems with a product or its
manufacturer may result in restrictions on the product or manufacturer,
including withdrawal of the product from the market. The sale by us or our
collaborators of any commercially viable product will be subject to government
regulation from several standpoints, including the processes of:
- manufacturing;
- advertising and
promoting;
- selling and
marketing;
- labeling; and
- distribution.
If, and to the extent
that, we are unable to comply with these regulations, our ability to earn
revenues will be materially and negatively impacted.
Failure to comply with regulatory requirements can result in severe civil
and criminal penalties, including but not limited to:
- recall or seizure of
products;
- injunction against the
manufacture, distribution and sales and marketing of products;
and
- criminal prosecution.
The imposition of any of
these penalties or other commercial limitations could significantly impair our
business, financial condition and results of operations.
RISKS RELATED TO PROTECTING OUR INTELLECTUAL
PROPERTY
Impairment of our intellectual property rights may adversely affect the
value of our technologies and product candidates and limit our ability to pursue
their development.
Protection of our proprietary technology is critically important to our
business. Our success will depend in part on our ability to obtain and enforce
our patents and maintain trade secrets, both in the United States and in other
countries. Further, our patents may be challenged, invalidated or circumvented,
and our patent rights may not provide proprietary protection or competitive
advantages to us. In the event that we are unsuccessful in obtaining and
enforcing patents, our business would be negatively impacted.
The patent positions of pharmaceutical and biopharmaceutical companies,
including ours, are highly uncertain and involve complex legal and technical
questions. In particular, legal principles for biotechnology and pharmaceutical
patents in the United States and in other countries are evolving, and the extent
to which we will be able to obtain patent coverage to protect our technology, or
enforce issued patents, is uncertain. In the United States, recent court
decisions in patent cases as well as proposed legislative changes to the patent
system only exacerbate this uncertainty. Furthermore, significant amendments to
the regulations governing the process of obtaining patents were proposed in a
new rule package by the United States Patent and Trademark Office (the Patent
Office) in 2007. The proposed new rules were widely regarded as detrimental to
the interests of biotechnology and pharmaceutical companies. The implementation
of the rule package was blocked by a court injunction requested by a
pharmaceutical company. The Patent Office challenged the court decision through
an appeal to the U.S. Court of Appeals for the Federal Circuit (CAFC), but the
appeal was dismissed in November 2009, after the Patent Office changed course
and rescinded the proposed new rules. At this point we do not know whether the
Patent Office will attempt to introduce new rules to replace those that were
recently withdrawn or whether any such new rules would also be
challenged.
31
In Europe, the European Patent Convention prohibits the granting of
European patents for inventions that concern “uses of human embryos for
industrial or commercial purposes.” The European Patent Office (EPO) was earlier
interpreting this prohibition broadly, and applying it to reject claims in any
patent application that pertained to hESCs. An early patent application filed by
the Wisconsin Alumni Research Foundation (WARF) with claims covering the
original isolation of hESCs was appealed as a test case, and examination of
other hESC patent applications was suspended while that case was heard. In
November 2008, the EPO Enlarged Board of Appeals held that the claims in the
WARF application were unpatentable. Geron holds a worldwide license under this
patent family, and since the decision is not subject to further appeal, this
WARF patent family will not afford protection to Geron’s hESC-based product
candidates in Europe. However, the reason given by the EPO for the decision was
narrowly focused: the EPO found the claims objectionable on the basis that at
the time that WARF filed the patent application it was necessary to use a human
embryo to obtain hESCs since no cell lines were available. In contrast, the
hESCs that we use, and which we employed in the technologies claimed in our own
European patent applications, were sourced from established hESC lines.
Consequently, the decision in the WARF case does not directly address the
patentability of the subject matter in our filings. The EPO has recently
restarted examination of hESC patent applications, but is being inconsistent in
its application of the WARF decision to these later filed cases. At this time,
we do not know whether or to what extent we will be able to obtain patent
protection for our hESC technologies in Europe. If we are unable to protect our
inventions related to hESCs in Europe, our business would be negatively
impacted.
Challenges to our patent rights can result in costly and time-consuming
legal proceedings that may prevent or limit development of our product
candidates.
Publication of discoveries in scientific or patent literature tends to
lag behind actual discoveries by at least several months and sometimes several
years. Therefore, the persons or entities that we or our licensors name as
inventors in our patents and patent applications may not have been the first to
invent the inventions disclosed in the patent applications or patents, or the
first to file patent applications for these inventions. As a result, we may not
be able to obtain patents for discoveries that we otherwise would consider
patentable and that we consider to be extremely significant to our future
success.
Where several parties seek U.S. patent protection for the same
technology, the Patent Office may declare an interference proceeding in order to
ascertain the party to which the patent should be issued. Patent interferences
are typically complex, highly contested legal proceedings, subject to appeal.
They are usually expensive and prolonged, and can cause significant delay in the
issuance of patents. Moreover, parties that receive an adverse decision in an
interference can lose important patent rights. Our pending patent applications,
or our issued patents, may be drawn into interference proceedings which may
delay or prevent the issuance of patents, or result in the loss of issued patent
rights. By way of example, we are currently a party to an interference
proceeding that involves patent filings for making endoderm cells from hESCs. We
requested that the Patent Office declare this interference after Novocell Inc.
(recently renamed ViaCyte, Inc.) was granted patent claims that conflict with
subject matter we filed in an earlier patent application. The interference
proceeding will determine whether ViaCyte is entitled to such patent claims. A
number of outcomes are possible: the claims may be awarded to ViaCyte; the
claims may be awarded to Geron, or neither party might be found to be entitled
to the claims. The decision from the Patent Office may also be subject to
appeal. Since the interference is still ongoing, we cannot predict what the
outcome will be.
Outside of the United States, certain jurisdictions, such as Europe, New
Zealand and Australia, permit oppositions to be filed against the granting of
patents. Because our intent is to commercialize products internationally,
securing both proprietary protection and freedom to operate outside of the
United States is important to our business. We are involved in both opposing the
grant of patents to others through such opposition proceedings and in defending
our patent applications against oppositions filed by others. For example, we
have been involved in two patent oppositions before the EPO with a Danish
company, Pharmexa. Pharmexa (which acquired the Norwegian company GemVax in
2005) was developing a cancer vaccine that employs a short telomerase peptide to
induce an immune response against telomerase and was conducting a Phase III
clinical trial. Pharmexa obtained a European patent with broad claims to the use
of telomerase vaccines for the treatment of cancer, and Geron opposed that
patent in 2004. In 2005, the Opposition Division (OD) of the EPO revoked the
claims originally granted to Pharmexa, but permitted Pharmexa to add new,
narrower claims limited to five specific small peptide fragments of telomerase.
The decision was appealed to the Technical Board of Appeals (TBA). In August
2007, the TBA ruled, consistent with the decision of the OD, that Pharmexa was
not entitled to the originally granted broad claims but was only entitled to the
narrow claims limited to the five small peptides.
32
In parallel, Pharmexa opposed a European patent held by Geron, the claims
of which cover many facets of human telomerase, including the use of telomerase
peptides in cancer vaccines. In June 2006, the OD of the EPO revoked three of
the granted claims in Geron’s patent, specifically the three claims covering
telomerase peptide cancer vaccines. We have appealed that decision to the TBA,
and that appeal is still pending. Because this appeal is ongoing, the outcome
cannot be determined at this time. In late 2008, Pharmexa reported that it sold
its telomerase vaccine program to a Korean company, KAEL Co. Ltd. We have
recently been awarded a second European patent with claims to telomerase
peptides, and this patent has also been opposed by KAEL-GemVax. We cannot
predict the outcome of this opposition or any subsequent appeal of the decision
in the opposition.
European opposition and appeal proceedings can take several years to
reach final decision. The oppositions discussed above reflect the complexity of
the patent landscape in which we operate, and illustrate the risks and
uncertainties. We are also currently involved in other patent opposition
proceedings in Europe and Australia.
Patent opposition proceedings are not currently available in the U.S.
patent system, but legislation has been proposed to introduce them. However,
issued U.S. patents can be reexamined by the Patent Office at the request of a
third party. Patents owned or licensed by Geron may therefore be subject to
reexamination. As in any legal proceeding, the outcome of patent reexaminations
is uncertain, and a decision adverse to our interests could result in the loss
of valuable patent rights.
In July 2006, requests were filed on behalf of the Foundation for
Taxpayer and Consumer Rights (now renamed as “Consumer Watchdog”) for
reexamination of three issued U.S. patents owned by WARF and relating to hESCs.
These three patents (U.S. Patent Nos. 5,843,780, 6,200,806 and 7,029,913), which
are the U.S. equivalents of the European WARF case discussed above, are licensed
to Geron pursuant to a January 2002 license agreement with WARF. The license
agreement conveys exclusive rights to Geron under the WARF patents for the
development and commercialization of therapeutics based on neural cells,
cardiomyocytes and pancreatic islet cells, derived from hESCs, as well as
non-exclusive rights for other product opportunities. In October 2006, the
Patent Office initiated the reexamination proceedings. After initially rejecting
the patent claims, the Patent Office issued decisions in all three cases
upholding the patentability of the claims. The decisions to uphold the 5,843,780
and 6,200,806 patents are final and not subject to further appeal. Consumer
Watchdog appealed the decision on the 7,029,913 patent. In April 2010, the Board
of Patent Appeals and Interferences reversed the earlier decision of the Patent
Office on the 7,029,913 patent. WARF will now have the opportunity to present
the claims for further examination at the Patent Office. We cooperated with WARF
in these reexamination actions and expect that WARF will continue to vigorously
defend its patent position. The final outcome of these or of any future
reexamination proceedings cannot be determined at this time. Reduction or loss
of claim scope in these WARF embryonic stem cell patents could negatively impact
Geron’s proprietary position in this technology.
As more groups become engaged in scientific research and product
development in the areas of telomerase biology and embryonic stem cells, the
risk of our patents being challenged through patent interferences, oppositions,
reexaminations or other means will likely increase. Challenges to our patents
through these procedures can be extremely expensive and time-consuming, even if
the outcome is favorable to us. An adverse outcome in a patent dispute could
severely harm our business by:
- causing us to lose patent rights
in the relevant jurisdiction(s);
- subjecting us to litigation, or
otherwise preventing us from commercializing potential products in the
relevant jurisdiction(s);
- requiring us to obtain licenses to
the disputed patents;
- forcing us to cease using the
disputed technology; or
- requiring us to develop or obtain
alternative technologies.
Furthermore, if such
challenges to our patent rights are not resolved promptly in our favor, our
existing business relationships may be jeopardized and we could be delayed or
prevented from entering into new collaborations or from commercializing certain
products, which could materially harm our business.
33
If we fail to meet our obligations under license agreements, we may lose
our rights to key technologies on which our business
depends.
Our business depends on several critical technologies that are based in
part on patents licensed from third parties. Those third-party license
agreements impose obligations on us, such as payment obligations and obligations
to diligently pursue development of commercial products under the licensed
patents. If a licensor believes that we have failed to meet our obligations
under a license agreement, the licensor could seek to limit or terminate our
license rights, which could lead to costly and time-consuming litigation and,
potentially, a loss of the licensed rights. During the period of any such
litigation our ability to carry out the development and commercialization of
potential products could be significantly and negatively affected. If our
license rights were restricted or ultimately lost, our ability to continue our
business based on the affected technology would be severely adversely
affected.
We may be subject to litigation that will be costly to defend or pursue
and uncertain in its outcome.
Our business may bring us into conflict with our licensees, licensors, or
others with whom we have contractual or other business relationships, or with
our competitors or others whose interests differ from ours. If we are unable to
resolve those conflicts on terms that are satisfactory to all parties, we may
become involved in litigation brought by or against us. That litigation is
likely to be expensive and may require a significant amount of management’s time
and attention, at the expense of other aspects of our business. The outcome of
litigation is always uncertain, and in some cases could include judgments
against us that require us to pay damages, enjoin us from certain activities, or
otherwise affect our legal or contractual rights, which could have a significant
adverse effect on our business.
We may be subject to infringement claims that are costly to defend, and
which may limit our ability to use disputed technologies and prevent us from
pursuing research and development or commercialization of potential
products.
Our commercial success depends significantly on our ability to operate
without infringing patents and the proprietary rights of others. Our
technologies may infringe the patents or proprietary rights of others. In
addition, we may become aware of discoveries and technology controlled by third
parties that are advantageous to our programs. In the event our technologies
infringe the rights of others or we require the use of discoveries and
technology controlled by third parties, we may be prevented from pursuing
research, development or commercialization of potential products or may be
required to obtain licenses to those patents or other proprietary rights or
develop or obtain alternative technologies. We have obtained licenses from
several universities and companies for technologies that we anticipate
incorporating into our potential products, and we initiate negotiation for
licenses to other technologies as the need or opportunity arises. We may not be
able to obtain a license to patented technology on commercially favorable terms,
or at all. If we do not obtain a necessary license, we may need to redesign our
technologies or obtain rights to alternate technologies, the research and
adoption of which could cause delays in product development. In cases where we
are unable to license necessary technologies, we could be prevented from
developing certain potential products. Our failure to obtain alternative
technologies or a license to any technology that we may require to research,
develop or commercialize our product candidates would significantly and
negatively affect our business.
Much of the information and know-how that is critical to our business is
not patentable and we may not be able to prevent others from obtaining this
information and establishing competitive enterprises.
We sometimes rely on trade secrets to protect our proprietary technology,
especially in circumstances in which we believe patent protection is not
appropriate or available. We attempt to protect our proprietary technology in
part by confidentiality agreements with our employees, consultants,
collaborators and contractors. We cannot assure you that these agreements will
not be breached, that we would have adequate remedies for any breach, or that
our trade secrets will not otherwise become known or be independently discovered
by competitors, any of which would harm our business significantly.
34
RISKS RELATED TO OUR RELATIONSHIPS WITH THIRD
PARTIES
We depend on other parties to help us develop, manufacture and test our
product candidates, and our ability to develop and commercialize potential
products may be impaired or delayed if collaborations are
unsuccessful.
Our strategy for the development, clinical testing and commercialization
of our product candidates requires that we enter into collaborations with
corporate partners, licensors, licensees and others. We are dependent upon the
subsequent success of these other parties in performing their respective
responsibilities and the continued cooperation of our partners. By way of
examples: Merck is developing cancer vaccines targeted to telomerase other than
dendritic cell-based vaccines; Sienna is developing cancer diagnostics using our
telomerase technology; and GE Healthcare UK Limited is developing cell-based
assays using cells derived from our hESCs. Our collaborators may not cooperate
with us or perform their obligations under our agreements with them. We cannot
control the amount and timing of our collaborators’ resources that will be
devoted to activities related to our collaborative agreements with them. Our
collaborators may choose to pursue existing or alternative technologies in
preference to those being developed in collaboration with us.
Under agreements with other parties,
we may rely significantly on them to, among other activities:
- conduct research and development
activities in conjunction with us;
- design and conduct advanced
clinical trials in the event that we reach clinical trials;
- fund research and development
activities with us;
- manage and license certain patent
rights;
- pay us fees upon the achievement
of milestones; and
- market with us any commercial
products that result from our collaborations.
The development and commercialization of potential products will be
delayed if collaborators or other partners fail to conduct these activities in a
timely manner or at all. In addition, our collaborators could terminate their
agreements with us and we may not receive any development or milestone payments.
If we do not achieve milestones set forth in the agreements, or if our
collaborators breach or terminate their collaborative agreements with us, our
business may be materially harmed.
We also rely on other companies for certain process development,
manufacturing or other technical scientific work, especially with respect to our
imetelstat, GRNVAC1, GRNOPC1 and GRNCM1 programs. We have contracts with these
companies that specify the work to be done and results to be achieved, but we do
not have direct control over their personnel or operations. If these companies
do not perform the work which they were assigned, our ability to develop or
manufacture our product candidates could be significantly harmed.
Our reliance on the activities of our non-employee consultants, research
institutions, and scientific contractors, whose activities are not wholly within
our control, may lead to delays in development of our product
candidates.
We rely extensively upon and have relationships with scientific
consultants at academic and other institutions, some of whom conduct research at
our request, and other consultants who assist us in formulating our research and
development and clinical strategy or other matters. These consultants are not
our employees and may have commitments to, or consulting or advisory contracts
with, other entities that may limit their availability to us. We have limited
control over the activities of these consultants and, except as otherwise
required by our collaboration and consulting agreements, can expect only limited
amounts of their time to be dedicated to our activities.
35
In addition, we have formed research collaborations with many academic
and other research institutions throughout the world. These research facilities
may have commitments to other commercial and noncommercial entities. We have
limited control over the operations of these laboratories and can expect only
limited amounts of their time to be dedicated to our research
goals.
If any of these third parties are unable or refuse to contribute to
projects on which we need their help, our ability to generate advances in our
technologies and develop our product candidates could be significantly harmed.
RISKS RELATED TO COMPETITIVE
FACTORS
The loss of key personnel could slow our ability to conduct research and
develop product candidates.
Our future success depends to a significant extent on the skills,
experience and efforts of our executive officers and key members of our
scientific staff. We face intense competition for qualified individuals from
numerous pharmaceutical, biopharmaceutical and biotechnology companies, as well
as academic and other research institutions. We may be unable to retain our
current personnel or attract or assimilate other highly qualified management and
scientific personnel in the future on acceptable terms. The loss of any or all
of these individuals could harm our business and might significantly delay or
prevent the achievement of research, development or business
objectives.
Our product candidates are likely to be expensive to manufacture, and
they may not be profitable if we are unable to significantly reduce the costs to
manufacture them.
Our telomerase inhibitor compound, imetelstat, our telomerase cancer
vaccine, GRNVAC1, and our hESC-based products are likely to be more expensive to
manufacture than most other treatments currently on the market today.
Oligonucleotides are relatively large molecules with complex chemistry, and the
cost of manufacturing an oligonucleotide like imetelstat is greater than the
cost of making most small-molecule drugs. Our present manufacturing processes
are conducted at a modest scale and we hope to substantially reduce
manufacturing costs through process improvements, as well as through scale
increases. If we are not able to do so, however, and, depending on the pricing
of the potential product, the profit margin on the telomerase inhibitor may be
significantly less than that of most drugs on the market today.
GRNVAC1 is an autologous therapy that is produced from a patient’s blood
using a unique process that generates highly activated dendritic cells that
contain RNA coding for the protein component of telomerase. If we are unable to
scalably produce dendritic cells at a lower manufacturing cost, the cost of
GRNVAC1 may reduce the affordability of the therapy for patients and reduce our
potential profitability.
Our manufacturing processes for differentiated cells from hESCs are
conducted at a small scale and at a high cost per unit measure. The cell-based
therapies we are developing based on hESCs will probably require large
quantities of cells. We continue to develop processes to scale up production of
the cells in a cost-effective way. We may not be able to charge a high enough
price for any cell therapy product we develop, even if it is safe and effective,
to make a profit. If we are unable to realize significant profits from our
potential product candidates, our business would be materially
harmed.
Some of our competitors may develop technologies that are superior to or
more cost-effective than ours, which may impact the commercial viability of our
technologies and which may significantly damage our ability to sustain
operations.
The pharmaceutical and biotechnology industries are intensely
competitive. Other pharmaceutical and biotechnology companies and research
organizations currently engage in or have in the past engaged in efforts related
to the biological mechanisms that are the focus of our programs in oncology and
human embryonic stem cell therapies, including the study of telomeres,
telomerase and hESCs. In addition, other products and therapies that could
compete directly with the product candidates that we are seeking to develop and
market currently exist or are being developed by pharmaceutical and
biopharmaceutical companies and by academic and other research
organizations.
36
Many companies are developing alternative therapies to treat cancer and,
in this regard, are competitors of ours. According to public data from the FDA
and NIH, there are more than 200 approved anti-cancer products on the market in
the United States, and several thousand in clinical development.
Many of the pharmaceutical companies developing and marketing these
competing products (including GlaxoSmithKline, Bristol-Myers Squibb Company and
Novartis AG, among others) have significantly greater financial resources and
expertise than we do in:
- research and
development;
- manufacturing;
- preclinical and clinical
testing;
- obtaining regulatory approvals;
and
- marketing and distribution.
Smaller companies may also prove to be significant competitors,
particularly through collaborative arrangements with large and established
companies. Academic institutions, government agencies and other public and
private research organizations may also conduct research, seek patent protection
and establish collaborative arrangements for research, clinical development and
marketing of products similar to ours. These companies and institutions compete
with us in recruiting and retaining qualified scientific and management
personnel as well as in acquiring technologies complementary to our
programs.
In addition to the above factors, we
expect to face competition in the following areas:
- product efficacy and
safety;
- the timing and scope of regulatory
consents;
- availability of
resources;
- reimbursement
coverage;
- price; and
- patent position, including
potentially dominant patent positions of others.
As a result of the
foregoing, our competitors may develop more effective or more affordable
products, or achieve earlier patent protection or product commercialization than
we do. Most significantly, competitive products may render any product
candidates that we develop obsolete, which would negatively impact our business
and ability to sustain operations.
To be successful, our product candidates must be accepted by the health
care community, which can be very slow to adopt or unreceptive to new
technologies and products.
Our product candidates and those developed by our collaborators, if
approved for marketing, may not achieve market acceptance since hospitals,
physicians, patients or the medical community in general may decide not to
accept and utilize these products. The product candidates that we are attempting
to develop represent substantial departures from established treatment methods
and will compete with a number of conventional drugs and therapies manufactured
and marketed by major pharmaceutical companies. The degree of market acceptance
of any of our developed potential products will depend on a number of factors,
including:
- our establishment and
demonstration to the medical community of the clinical efficacy and safety of
our product candidates;
- our ability to create products
that are superior to alternatives currently on the market;
- our ability to establish in the
medical community the potential advantage of our treatments over alternative
treatment methods; and
- reimbursement policies of
government and third-party payors.
If the health care
community does not accept our potential products for any of the foregoing
reasons, or for any other reason, our business would be materially
harmed.
37
If we fail to obtain acceptable prices or adequate reimbursement for our
product candidates, the use of our potential products could be severely
limited.
Our ability to successfully commercialize our product candidates will
depend significantly on our ability to obtain acceptable prices and the
availability of reimbursement to the patient from third-party payors. In March
2010, President Obama signed the Patient Protection and Affordability Care Act,
as amended by the Health Care and Education Affordability Reconciliation Act
(collectively, the PPACA) into law. Focused on expanding healthcare coverage to
millions of uninsured Americans and reducing the rate of increase in healthcare
costs, the PPACA contains numerous initiatives that impact the pharmaceutical
industry. These include, among other things:
- increasing existing price rebates
in federally funded health care programs;
- expanding rebates, or other
pharmaceutical company discounts, into new programs;
- imposing a new non-deductible
excise tax on sales of certain prescription pharmaceutical products by
prescription drug manufacturers and importers;
- reducing incentives for
employer-sponsored health care;
- creating an independent commission
to propose changes to Medicare with a particular focus on the cost of
biopharmaceuticals in Medicare Part D;
- providing a government-run public
option with biopharmaceutical price-setting capabilities;
- allowing the Secretary of Health
and Human Services to negotiate drug prices within Medicare Part D directly
with pharmaceutical manufacturers;
- reducing the number of years of
data exclusivity for innovative biological products potentially leading to
earlier biosimilar competition;
- increasing oversight by the FDA of
pharmaceutical research and development processes and commercialization
tactics; and
- adding a tax credit for qualifying
therapeutic discovery projects (QTDP).
While the PPACA may increase the number of patients who have insurance
coverage for our product candidates, its cost containment measures could also
adversely affect reimbursement for our potential products. Cost control
initiatives could decrease the price that we receive for any product candidate
we may develop in the future. If our potential products are not considered
cost-effective or if we fail to generate adequate third-party reimbursement for
the users of our potential products and treatments, then we may be unable to
maintain price levels sufficient to realize an appropriate return on our
investment for potential products currently in development, which could have an
adverse impact on our business.
The QTDP tax credit is equal to 50% of qualifying expenses incurred or
directly related to the conduct of a qualifying therapeutic discovery project
for taxable years beginning in 2009 and 2010. The credit can be used to either
reduce the federal tax liability for an eligible taxpayer or be received as a
grant for the same amount tax free. Eligible taxpayers must be a single employer
of not more than 250 employees. To qualify for the credit, a project must be
submitted to and certified by the Treasury Department. The deadline for the QTDP
application was July 21, 2010 and final decision on the awardees will be
announced by October 31, 2010. Although our research and development activities
appear to meet the initial criteria to receive a tax credit, we cannot predict
the availability or amount of funds that could be received. If we are
unsuccessful in obtaining the benefits of the QTDP tax credit and our
competitors are successful, our business may be adversely impacted.
38
RISKS RELATED TO ENVIRONMENTAL AND PRODUCT
LIABILITY
Our activities involve hazardous materials, and improper handling of
these materials by our employees or agents could expose us to significant legal
and financial penalties.
Our research and development activities involve the controlled use of
hazardous materials, chemicals and various radioactive compounds. As a
consequence, we are subject to numerous environmental and safety laws and
regulations, including those governing laboratory procedures, exposure to
blood-borne pathogens and the handling of biohazardous materials. We may be
required to incur significant costs to comply with current or future
environmental laws and regulations and may be adversely affected by the cost of
compliance with these laws and regulations.
Although we believe that our safety procedures for using, handling,
storing and disposing of hazardous materials comply with the standards
prescribed by state and federal regulations, the risk of accidental
contamination or injury from these materials cannot be eliminated. In the event
of such an accident, state or federal authorities could curtail our use of these
materials and we could be liable for any civil damages that result, the cost of
which could be substantial. Further, any failure by us to control the use,
disposal, removal or storage, or to adequately restrict the discharge, or assist
in the clean up, of hazardous chemicals or hazardous, infectious or toxic
substances could subject us to significant liabilities, including joint and
several liability under certain statutes. Any such liability could exceed our
resources and could have a material adverse effect on our business, financial
condition and results of operations. Additionally, an accident could damage our
research and manufacturing facilities and operations.
Additional federal, state and local laws and regulations affecting us may
be adopted in the future. We may incur substantial costs to comply with these
laws and regulations and substantial fines or penalties if we violate any of
these laws or regulations, which would adversely affect our business.
We may not be able to obtain or maintain sufficient insurance on
commercially reasonable terms or with adequate coverage against potential
liabilities in order to protect ourselves against product liability
claims.
Our business exposes us to potential product liability risks that are
inherent in the testing, manufacturing and marketing of human therapeutic and
diagnostic products. We may become subject to product liability claims if the
use of our potential products is alleged to have injured subjects or patients.
This risk exists for product candidates tested in human clinical trials as well
as potential products that are sold commercially. We currently have limited
clinical trial liability insurance and we may not be able to maintain this type
of insurance for any of our clinical trials. In addition, product liability
insurance is becoming increasingly expensive. Being unable to obtain or maintain
product liability insurance in the future on acceptable terms or with adequate
coverage against potential liabilities could have a material adverse effect on
our business.
RISKS RELATED TO OUR COMMON STOCK AND
FINANCIAL REPORTING
Our stock price has historically been very
volatile.
Stock prices and trading volumes for many biopharmaceutical companies
fluctuate widely for a number of reasons, including factors which may be
unrelated to their businesses or results of operations such as media coverage,
legislative and regulatory measures and the activities of various interest
groups or organizations. This market volatility, as well as general domestic or
international economic, market and political conditions, could materially and
adversely affect the market price of our common stock and the return on your
investment.
Historically, our stock price has been extremely volatile. Between
January 2000 and June 2010, our stock has traded as high as $75.88 per share and
as low as $1.41 per share. Between January 1, 2007 and June 30, 2010, the price
has ranged between a high of $9.85 per share and a low of $1.95 per share. The
significant market price fluctuations of our common stock are due to a variety
of factors, including:
- the demand in the market for our
common stock;
- the experimental nature of our
product candidates;
39
- fluctuations in our operating
results;
- market conditions relating to the
biopharmaceutical and pharmaceutical industries;
- announcements of technological
innovations, new commercial products, or clinical progress or lack thereof by
us, our collaborative partners or our competitors;
- announcements concerning
regulatory developments, developments with respect to proprietary rights and
our collaborations;
- comments by securities
analysts;
- general market
conditions;
- political developments related to
hESC research;
- public concern with respect to our
product candidates; or
- the issuance of common stock to
partners, vendors or to investors to raise additional capital.
In addition, the stock market is subject to other factors outside our
control that can cause extreme price and volume fluctuations. In the third and
fourth quarters of 2008, as well as during 2009, broad distress in the financial
markets and the economy have resulted in greatly increased market uncertainty
and instability in both U.S. and international capital and credit markets. These
conditions, combined with volatile oil prices, declining business and consumer
confidence and increased unemployment have recently contributed to substantial
market volatility, and if such market conditions persist, the price of our
common stock may fluctuate or decline. Securities class action litigation has
often been brought against companies, including many biotechnology companies,
which experience volatility in the market price of their securities. Litigation
brought against us could result in substantial costs and a diversion of
management’s attention and resources, which could adversely affect our
business.
The sale of a substantial number of shares may adversely affect the
market price for our common stock.
The sale of a substantial number of shares of our common stock in the
public market, or the perception that such sales could occur, could
significantly and negatively affect the market price for our common stock. As of
June 30, 2010, we had 200,000,000 shares of common stock authorized for issuance
and 98,918,938 shares of common stock outstanding. In addition, as of June 30,
2010, we have reserved for future issuance approximately 26,107,429 shares of
common stock for our stock plans, potential milestone payments and outstanding
warrants.
In addition, we have issued common stock to certain parties, such as
vendors and service providers, as payment for products and services. Under these
arrangements, we typically agree to register the shares for resale soon after
their issuance. We may continue to pay for certain goods and services in this
manner, which would dilute your interest in us. Also, sales of the shares issued
in this manner could negatively affect the market price for our common
stock.
Our undesignated preferred stock may inhibit potential acquisition bids;
this may adversely affect the market price for our common stock and the voting
rights of holders of our common stock.
Our certificate of incorporation provides our Board of Directors with the
authority to issue up to 3,000,000 shares of undesignated preferred stock and to
determine or alter the rights, preferences, privileges and restrictions granted
to or imported upon these shares without further vote or action by our
stockholders. As of the date of this Form 10-Q, 50,000 shares of preferred stock
have been designated Series A Junior Participating Preferred Stock and the Board
of Directors still has authority to designate and issue up to 2,950,000 shares
of preferred stock in one or more classes or series. The issuance of shares of
preferred stock may delay or prevent a change in control transaction without
further action by our stockholders. As a result, the market price for our common
stock may be adversely affected.
40
In addition, if we issue preferred stock in the future that has
preference over our common stock with respect to the payment of dividends or
upon our liquidation, dissolution or winding up, or if we issue preferred stock
with voting rights that dilute the voting power of our common stock, the rights
of holders of our common stock or the market price for our common stock could be
adversely affected.
Provisions in our share purchase rights plan, charter and bylaws, and
provisions of Delaware law, may inhibit potential acquisition bids for us, which
may prevent holders of our common stock from benefiting from what they believe
may be the positive aspects of acquisitions and takeovers.
Our Board of Directors has adopted a share purchase rights plan, commonly
referred to as a “poison pill.” This plan entitles existing stockholders to
rights, including the right to purchase shares of common stock, in the event of
an acquisition of 15% or more of our outstanding common stock.
Our share purchase rights plan could prevent stockholders from profiting
from an increase in the market value of their shares as a result of a change of
control of us by delaying or preventing a change of control. In addition, our
Board of Directors has the authority, without further action by our
stockholders, to issue additional shares of common stock, and to fix the rights
and preferences of one or more series of preferred stock.
In addition to our share purchase rights plan and the undesignated
preferred stock, provisions of our charter documents and bylaws may make it
substantially more difficult for a third party to acquire control of us and may
prevent changes in our management, including provisions that:
- prevent stockholders from taking
actions by written consent;
- divide the Board of Directors into
separate classes with terms of office that are structured to prevent all of
the directors from being elected in any one year; and
- set forth procedures for
nominating directors and submitting proposals for consideration at
stockholders’ meetings.
Provisions of Delaware law may also inhibit potential acquisition bids
for us or prevent us from engaging in business combinations. In addition, we
have severance agreements with several employees and a change of control
severance plan which could require an acquiror to pay a higher price. Either
collectively or individually, these provisions may prevent holders of our common
stock from benefiting from what they may believe are the positive aspects of
acquisitions and takeovers, including the potential realization of a higher rate
of return on their investment from these types of transactions.
We do not intend to pay cash dividends on our common stock in the
foreseeable future.
We do not anticipate paying cash dividends on our common stock in the
foreseeable future. Any payment of cash dividends will depend upon our financial
condition, results of operations, capital requirements and other factors and
will be at the discretion of the Board of Directors. Furthermore, we may incur
additional indebtedness that may severely restrict or prohibit the payment of
dividends.
Failure to achieve and maintain effective internal controls in accordance
with Section 404 of the Sarbanes-Oxley Act of 2002 could have a material adverse
effect on our business and stock price.
Section 404 of the Sarbanes-Oxley Act of 2002 (the Sarbanes-Oxley Act)
requires that we establish and maintain an adequate internal control structure
and procedures for financial reporting. Our annual report on Form 10-K must
contain an assessment by management of the effectiveness of our internal control
over financial reporting and must include disclosure of any material weaknesses
in internal control over financial reporting that we have identified. In
addition, our independent registered public accounting firm must annually
provide an opinion on the effectiveness of our internal control over financial
reporting.
The requirements of Section 404 of the Sarbanes-Oxley Act are ongoing and
also apply to future years. We expect that our internal control over financial
reporting will continue to evolve as our business develops. Although we are
committed to continue to improve our internal control processes and we will
continue to diligently and vigorously review our internal control over financial
reporting in order to ensure compliance with Section 404 requirements, any
control system, regardless of how well designed, operated and evaluated, can
provide only reasonable, not absolute, assurance that its objectives will be
met. Therefore, we cannot be certain that in the future material weaknesses or
significant deficiencies will not exist or otherwise be discovered. If material
weaknesses or other significant deficiencies occur, these weaknesses or
deficiencies could result in misstatements of our results of operations,
restatements of our consolidated financial statements, a decline in our stock
price, or other material adverse effects on our business, reputation, results of
operations, financial condition or liquidity.
41
ITEM 2. UNREGISTERED SALES OF EQUITY
SECURITIES AND USE OF PROCEEDS
On April 6, 2010, we issued to Girindus America, Inc. (Girindus) 293,225
shares of our common stock in a private placement as consideration for a project
order under a manufacturing agreement pursuant to which Girindus is
manufacturing certain materials for us intended for therapeutic use in humans.
The fair value of the common stock of $1,680,000 was recorded as a prepaid asset
and is being amortized to research and development expense on a pro-rata basis
as services are performed and the proper materials are received. As of June 30,
2010, $1,147,000 remained as a prepaid asset which is expected to be expensed
over the next six months.
On April 6, 2010, we issued to ReSearch Pharmaceutical Services, Inc.
(RPS) 259,965 shares of our common stock in a private placement as consideration
for a project agreement under a master services agreement pursuant to which RPS
is providing certain services in support of our clinical programs. The fair
value of the common stock of $1,490,000 was recorded as a prepaid asset and is
being amortized to research and development expense on a pro-rata basis as
services are performed. As of June 30, 2010, $1,062,000 remained as a prepaid
asset which is expected to be expensed over the next six months.
On April 6, 2010, we issued to Prime Synthesis, Inc. (Prime Synthesis)
24,536 shares of our common stock in a private placement as consideration for an
addendum agreement under a master supply agreement pursuant to which Prime
Synthesis is manufacturing certain materials for us intended for therapeutic use
in humans. The fair value of the common stock of $141,000 was recorded as a
prepaid asset and as of June 30, 2010, has been fully amortized to research and
development expense in connection with receipt of the proper
materials.
On April 6, 2010, we issued to Exponent, Inc. (Exponent), the lessor of
the premises at 149 Commonwealth Drive, 93,258 shares of our common stock in a
private placement as a final installment payment of rent due under the extended
lease agreement for the period from May 1, 2010 through July 31, 2012. The fair
value of the common stock of $540,000 has been recorded as a prepaid asset and
is being amortized to rent expense on a pro-rata basis over the lease
term.
We issued the above-described shares of common stock in independent
transactions and in reliance upon the exemption from registration provided by
Section 4(2) of the Securities Act of 1933, as amended. Each of Girindus, RPS,
Prime Synthesis and Exponent represented to us that it is an accredited investor
as defined in Rule 501(a) of the Securities Act of 1933, as amended, and that
the securities issued pursuant thereto were being acquired for investment
purposes.
Purchases of Equity Securities by the Issuer
and Affiliated Purchasers
None.
ITEM 3. DEFAULTS UPON SENIOR
SECURITIES
None.
ITEM 4. (REMOVED AND RESERVED)
None.
42
ITEM 5. OTHER INFORMATION
None.
ITEM 6. EXHIBITS
Exhibit |
|
|
Number |
|
Description |
10.1+ |
|
Amended and Restated 2002 Equity
Incentive Plan |
|
|
|
31.1
|
|
Certification of
Chief Executive Officer pursuant to Form of Rule 13a-14(a) and 15d-14(a),
as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002,
dated July 30, 2010.
|
|
|
|
31.2
|
|
Certification of
Chief Financial Officer pursuant to Form of Rule 13a-14(a) and 15d-14(a),
as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002,
dated July 30, 2010.
|
|
|
|
32.1
|
|
Certification of
Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as Adopted
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, dated July 30,
2010.
|
|
|
|
32.2
|
|
Certification of
Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as Adopted
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, dated July 30,
2010.
|
____________________
+ |
|
Incorporated by
reference to Appendix A to the Company’s Definitive Proxy Statement filed
with the Securities and
Exchange Commission on March 29, 2010. |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this Report to be signed on its behalf by the
undersigned, thereunto duly authorized.
|
GERON
CORPORATION
|
|
|
|
|
|
|
By: |
/s/ DAVID L.
GREENWOOD |
|
|
|
David L. Greenwood |
|
|
Executive Vice President
and |
|
|
Chief Financial Officer |
Date: July 30, 2010 |
|
(Duly Authorized
Signatory) |
43
EXHIBIT INDEX
Exhibit |
|
|
Number |
|
Description |
10.1+ |
|
Amended and Restated 2002 Equity
Incentive Plan |
|
|
|
31.1
|
|
Certification of
Chief Executive Officer pursuant to Form of Rule 13a-14(a) and 15d-14(a),
as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002,
dated July 30, 2010.
|
|
|
|
31.2
|
|
Certification of
Chief Financial Officer pursuant to Form of Rule 13a-14(a) and 15d-14(a),
as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002,
dated July 30, 2010.
|
|
|
|
32.1
|
|
Certification of
Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as Adopted
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, dated July 30,
2010.
|
|
|
|
32.2
|
|
Certification of
Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as Adopted
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, dated July 30,
2010.
|
____________________
+ |
|
Incorporated by
reference to Appendix A to the Company’s Definitive Proxy Statement filed
with the Securities and Exchange Commission on March 29,
2010. |