|
x
|
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
o
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
Delaware
|
|
77-0579396
|
(State or other jurisdiction of
incorporation or organization)
|
|
(I.R.S. Employer
Identification Number)
|
|
|
|
Title of Each Class
|
|
Name of Each Exchange on Which Registered
|
Common stock, par value $0.001 per share
|
|
Over The Counter (OTC)
|
Large accelerated filer
o
|
|
Accelerated filer
o
|
|
|
|
Non-accelerated filer
x
(Do not check if a smaller reporting company)
|
|
Smaller reporting company
o
|
|
|
|
Page
|
|
|
|
|
|
|
|
PART II
.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
•
|
preclinical laboratory tests and animal tests conducted in compliance with FDA's good laboratory practice requirements;
|
•
|
development, manufacture and testing of API and dosage forms suitable for human use in compliance with current good manufacturing practices, or GMP;
|
•
|
the submission to the FDA of an IND for human clinical testing, which must become effective before human clinical trials may begin;
|
•
|
adequate and well-controlled human clinical trials to establish the safety and efficacy of the product for its specific intended use(s);
|
•
|
the submission to the FDA of a NDA; and
|
•
|
FDA review and approval of the NDA.
|
•
|
discontinue operations;
|
•
|
abandon or relinquish some or all of our existing rights to OMONTYS milestones, royalties or other existing rights; or
|
•
|
pursue alternatives such as a sale of the Company or its assets, a corporate merger, wind-down of operations or even bankruptcy proceedings.
|
•
|
create market demand for OMONTYS through education, marketing and sales activities, including the ability to establish or demonstrate the safety of the product;
|
•
|
build a qualified commercial and medical affairs organization and field force;
|
•
|
achieve market acceptance and generate product sales through Takeda's execution of agreements with the major operators of dialysis clinics on commercially reasonable terms;
|
•
|
support the efforts of dialysis clinics to safely and effectively administer OMONTYS to dialysis patients on a different treatment plan than for the other approved erythropoiesis stimulating agents, or ESAs;
|
•
|
receive adequate levels of reimbursement from third-party payors, including government healthcare programs such as Medicare and Medicaid and private insurance programs;
|
•
|
comply with the post-marketing requirements established by the FDA, including the Risk Evaluation and Mitigation Strategy, or REMS, and any other requirements established by the FDA in the future;
|
•
|
comply with other healthcare regulatory requirements;
|
•
|
ensure that the Active Pharmaceutical Ingredient, or API, for OMONTYS and the finished product are manufactured in sufficient quantities and in compliance with requirements of the FDA and similar foreign regulatory agencies and with an acceptable quality and pricing level in order to meet commercial demand; and
|
•
|
ensure that the entire supply chain for OMONTYS - from API to finished product - efficiently and consistently delivers OMONTYS to customers.
|
•
|
In 2007, as a result of concerns associated with administering ESAs to target higher hemoglobin levels, the FDA required that revised warnings, including boxed warnings, be added to the labels of currently marketed ESAs advising physicians to monitor hemoglobin levels and to use the lowest dose of ESA to increase the hemoglobin concentration to the lowest level sufficient to avoid the need for red blood cell transfusions.
|
•
|
In late 2009, Amgen announced the results from the Trial to Reduce Cardiovascular Endpoints with Aranesp Therapy, or TREAT, its large, randomized, double-blind, placebo-controlled Phase 3 study of patients with chronic kidney disease (not requiring dialysis), anemia and type-2 diabetes. In this study, Aranesp was used to treat anemia to a target hemoglobin of 13 g/dL, which was higher than the 10 g/dL - 12 g/dL range previously approved by the FDA in the label. Study results reportedly failed to show benefit compared to the control group with regard to composite of time to all-cause mortality or cardiovascular morbidity (including heart failure, heart attack, stroke, or hospitalization for myocardial ischemia) and a composite of time to all-cause mortality or chronic renal replacement. In addition, higher rates of stroke were reported among patients treated with Aranesp compared to the control group. Finally, among a subgroup of patients with a history of cancer at baseline, a statistically significant increase in deaths from cancer was observed in the Aranesp-treated patients compared to placebo-treated patients.
|
•
|
In January 2010, FDA officials published an editorial in the New England Journal of Medicine noting that a number of randomized trials, including TREAT, had attempted to show that using ESAs to raise hemoglobin concentrations to higher targets improves clinical outcomes but rather suggested the opposite. Accordingly, the article indicated that more conservative hemoglobin targets (well below 12 g/dL), more frequent hemoglobin monitoring, and more cautious dosing, should be evaluated.
|
•
|
In February 2010, the FDA announced that ESAs must be prescribed and used under a REMS to ensure the safe use of the drugs. As part of the REMS, a medication guide explaining the risks and benefits of ESAs must be provided to all patients receiving ESAs for all indications, and the manufacturer has reporting and monitoring obligations to ensure compliance.
|
•
|
In June 2011, the FDA cited increased risks of cardiovascular events as a basis for more conservative dosing guidelines for use of ESAs in chronic kidney disease and announced related changes to ESA labeling. The FDA removed the prior target range of 10-12 g/dL and while separately issuing guidance for non-dialysis patients, the FDA recommended that dialysis patients initiate treatment when the hemoglobin is less than 10 g/dL and to reduce or interrupt dosing if hemoglobin level approaches or exceeds 11 g/dL. The FDA also required Amgen to conduct additional clinical trials to explore dosing strategies, including in dialysis patients to minimize hemoglobin variability, rates of change and excursions.
|
•
|
In February 2013, in connection with the recall, the FDA announced that due to the severity of the public health risk, the FDA wanted to be certain that health care providers stop using OMONTYS and that it would investigate products and facilities associated with the recall and would provide updates.
|
•
|
product quality issues;
|
•
|
cost overruns, process scale-up, process reproducibility;
|
•
|
changes in demand forecasts that result in inventory write-offs;
|
•
|
difficulties in maintaining or upgrading equipment and manufacturing facilities on a timely basis; and
|
•
|
regulatory issues or changes that may cause significant modifications in the manufacturing process or facilities or otherwise impact our ability to offer competitive product presentations or formulations.
|
•
|
others may be able to make similar compounds but that are not covered by the claims of our patents, or for which we are not licensed under our license agreements;
|
•
|
we or our licensors or collaborators might not have been the first to make the inventions covered by our pending patent applications or the pending patent applications and issued patents of our licensors;
|
•
|
we or our licensors or collaborators might not have been the first to file patent applications for these inventions;
|
•
|
others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights;
|
•
|
it is possible that our pending patent applications will not result in issued patents;
|
•
|
our issued patents and the issued patents of our licensors or collaborators may not provide us with any competitive advantages, or may be held invalid or unenforceable as a result of legal challenges by third parties;
|
•
|
we may not develop additional proprietary technologies that are patentable; or
|
•
|
the patents of others may have an adverse effect on our business.
|
•
|
federal “sunshine” laws that require transparency regarding financial arrangements with healthcare providers, such as the reporting and disclosure requirements imposed on drug manufacturers by the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Affordability Reconciliation Act, or collectively, PPACA, regarding any “transfer of value” made or distributed to prescribers and other health care providers;
|
•
|
the federal healthcare programs' Anti-Kickback Law, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under federal healthcare programs such as the Medicare and Medicaid programs;
|
•
|
federal false claims laws which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payors that are false or fraudulent; the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created federal criminal laws that prohibit executing a scheme to defraud any health care benefit program or making false statements relating to health care matters;
|
•
|
the Federal Food, Drug and Cosmetic Act, which prohibits, among other things, individuals or entities from introducing into interstate commerce any food, drug, device or cosmetic that has been adulterated or misbranded; and
|
•
|
state law equivalents of certain of the above federal laws, such as anti-kickback and false claims laws which may apply to items or services reimbursed by any third-party payor, including commercial insurers.
|
•
|
Takeda's ability to rapidly identify and address the cause of the safety concerns related to OMONTYS;
|
•
|
Takeda's ability to demonstrate safety of OMONTYS to the satisfaction of the FDA and reintroduce the product;
|
•
|
our ability to fund our operations and continue as a going concern;
|
•
|
litigation, including the securities class action lawsuits and derivative lawsuits pending against us and certain of our officers;
|
•
|
changes in the market valuations of similar companies;
|
•
|
actual or anticipated results from, and any delays in, commercialization of OMONTYS should Takeda reintroduce the product;
|
•
|
actual or anticipated contractual arrangements for OMONTYS should Takeda reintroduce OMONTYS or competing products;
|
•
|
actual or anticipated changes in our funding requirements, capital resources and our ability to obtain financing and the terms thereof;
|
•
|
actual or anticipated actions taken by regulatory agencies including the FDA and CMS with respect to ESAs generally or OMONTYS specifically;
|
•
|
new products or services introduced or announced by Takeda or our competitors, including Roche's Mircera or biosimilars, and the timing of these introductions or announcements;
|
•
|
actions taken by regulatory agencies with respect to clinical trials, manufacturing process or sales and marketing activities for OMONTYS;
|
•
|
changes in laws or regulations applicable to OMONTYS;
|
•
|
developments concerning our amended collaboration arrangement with Takeda;
|
•
|
actual or anticipated variations in our quarterly operating results due to our restructuring efforts;
|
•
|
conditions or trends in the biotechnology and biopharmaceutical industries;
|
•
|
announcements by us or our competitors of significant acquisitions, strategic partnerships, joint ventures or capital commitments;
|
•
|
general economic and market conditions and other factors that may be unrelated to our operating performance or the operating performance of our competitors;
|
•
|
sales of common stock or other securities by us or our stockholders in the future;
|
•
|
the loss of services of substantially all of our personnel, including all of our executive officers;
|
•
|
developments relating to proprietary rights held by us or our competitors;
|
•
|
disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies; and
|
•
|
trading volume of our common stock.
|
•
|
authorizing the issuance of “blank check” preferred stock, the terms of which may be established and shares of which may be issued without stockholder approval;
|
•
|
limiting the removal of directors by the stockholders;
|
•
|
prohibiting stockholder action by written consent, thereby requiring all stockholder actions to be taken at a meeting of our stockholders;
|
•
|
eliminating the ability of stockholders to call a special meeting of stockholders;
|
•
|
establishing advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted upon at stockholder meetings; and
|
•
|
our board of directors is classified, consisting of three classes of directors with staggered three-year terms, with each class consisting as nearly as possible of one third of the total number of directors.
|
|
High
|
|
Low
|
2013
|
|
|
|
4th Quarter
|
$1.33
|
|
$0.76
|
3rd Quarter
|
$1.99
|
|
$0.96
|
2nd Quarter
|
$2.08
|
|
$0.80
|
1st Quarter
|
$21.56
|
|
$1.05
|
|
High
|
|
Low
|
2012
|
|
|
|
4th Quarter
|
$27.74
|
|
$18.28
|
3rd Quarter
|
$22.00
|
|
$11.73
|
2nd Quarter
|
$14.95
|
|
$10.86
|
1st Quarter
|
$16.25
|
|
$6.35
|
(1)
|
This Section is not "soliciting material," is not deemed "filed" with the Commission and is not to be incorporated by reference into any filing of Affymax, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date hereof and irrespective of any general incorporation language in any such filing.
|
|
Year ended December 31,
|
||||||||||||||||||
|
2013
|
|
2012
|
|
2011
|
|
2010
|
|
2009
|
||||||||||
|
(in thousands, except per share data)
|
||||||||||||||||||
Statements of Operations Data:
|
|
|
|
|
|
|
|
|
|
||||||||||
Revenue:
|
|
|
|
|
|
|
|
|
|
||||||||||
Collaboration revenue
|
$
|
1,364
|
|
|
$
|
94,358
|
|
|
$
|
47,703
|
|
|
$
|
112,503
|
|
|
$
|
114,883
|
|
License and royalty revenue
|
5
|
|
|
12
|
|
|
17
|
|
|
18
|
|
|
16
|
|
|||||
Total revenue
|
1,369
|
|
|
94,370
|
|
|
47,720
|
|
|
112,521
|
|
|
114,899
|
|
|||||
Operating expenses:
|
|
|
|
|
|
|
|
|
|
||||||||||
Impairment of inventory and losses under firm purchase commitments
|
—
|
|
|
44,957
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Research and development
|
11,857
|
|
|
51,738
|
|
|
76,308
|
|
|
93,638
|
|
|
157,125
|
|
|||||
Selling, general and administrative
|
27,529
|
|
|
89,714
|
|
|
32,818
|
|
|
33,331
|
|
|
36,716
|
|
|||||
Collaboration cost reimbursement
|
(43,451
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Impairment (gain on disposal) of prepaid expenses, fixed assets and intangible assets
|
4,414
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
2013 Restructuring charge
|
16,066
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Total operating expenses
|
16,415
|
|
|
186,409
|
|
|
109,126
|
|
|
126,969
|
|
|
193,841
|
|
|||||
Loss from operations
|
(15,046
|
)
|
|
(92,039
|
)
|
|
(61,406
|
)
|
|
(14,448
|
)
|
|
(78,942
|
)
|
|||||
Interest income
|
21
|
|
|
77
|
|
|
169
|
|
|
275
|
|
|
934
|
|
|||||
Interest expense
|
(1,565
|
)
|
|
(1,442
|
)
|
|
(144
|
)
|
|
(140
|
)
|
|
(105
|
)
|
|||||
Other income (expense), net
|
8
|
|
|
(34
|
)
|
|
15
|
|
|
239
|
|
|
171
|
|
|||||
Loss before provision (benefit) for income taxes
|
(16,582
|
)
|
|
(93,438
|
)
|
|
(61,366
|
)
|
|
(14,074
|
)
|
|
(77,942
|
)
|
|||||
Provision (benefit) for income taxes
|
(2,158
|
)
|
|
(26
|
)
|
|
1
|
|
|
1
|
|
|
(1,411
|
)
|
|||||
Net loss
|
$
|
(14,424
|
)
|
|
$
|
(93,412
|
)
|
|
$
|
(61,367
|
)
|
|
$
|
(14,075
|
)
|
|
$
|
(76,531
|
)
|
Net loss per common share:
|
|
|
|
|
|
|
|
|
|
||||||||||
Basic and diluted (1)
|
$
|
(0.39
|
)
|
|
$
|
(2.57
|
)
|
|
$
|
(1.84
|
)
|
|
$
|
(0.57
|
)
|
|
$
|
(4.06
|
)
|
Weighted-average number of common shares used in computing basic and diluted net loss per loss common share
|
37,448
|
|
|
36,342
|
|
|
33,288
|
|
|
24,488
|
|
|
18,865
|
|
|
December 31,
|
||||||||||||||||||
|
2013
|
|
2012
|
|
2011
|
|
2010
|
|
2009
|
||||||||||
|
(in thousands)
|
||||||||||||||||||
Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
||||||||||
Cash, cash equivalents and short-term investments
|
$
|
5,597
|
|
|
$
|
77,982
|
|
|
$
|
98,504
|
|
|
$
|
97,081
|
|
|
$
|
160,588
|
|
Receivable from Takeda
|
—
|
|
|
18,365
|
|
|
6,937
|
|
|
—
|
|
|
18,561
|
|
|||||
Long-term investments
|
—
|
|
|
2,323
|
|
|
—
|
|
|
19,876
|
|
|
7,978
|
|
|||||
Total assets
|
7,443
|
|
|
118,217
|
|
|
118,995
|
|
|
131,387
|
|
|
211,510
|
|
|||||
Payable to Takeda
|
—
|
|
|
—
|
|
|
—
|
|
|
5,958
|
|
|
—
|
|
|||||
Deposit from Takeda
|
—
|
|
|
559
|
|
|
1,998
|
|
|
—
|
|
|
—
|
|
|||||
Advance from Takeda
|
8,189
|
|
|
27,715
|
|
|
6,121
|
|
|
—
|
|
|
—
|
|
|||||
Notes payable
|
—
|
|
|
8,844
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Accumulated deficit
|
(558,137
|
)
|
|
(543,713
|
)
|
|
(450,301
|
)
|
|
(388,934
|
)
|
|
(374,859
|
)
|
|||||
Total stockholders' equity (deficit)
|
$
|
(1,428
|
)
|
|
$
|
8,281
|
|
|
$
|
75,997
|
|
|
$
|
72,547
|
|
|
$
|
66,905
|
|
(1)
|
Please see Note 2 of Notes to Financial Statements for an explanation of the method used to calculate the net loss per common share and the number of shares used in the computation of the per share amounts.
|
|
Year ended December 31,
|
|
Percent Change
|
||||||||||||||
|
2013
|
|
2012
|
|
2011
|
|
2013/2012
|
|
2012/2011
|
||||||||
Collaboration revenue
|
$
|
1,364
|
|
|
$
|
94,358
|
|
|
$
|
47,703
|
|
|
(99
|
)%
|
|
98
|
%
|
License and royalty revenue
|
5
|
|
|
12
|
|
|
17
|
|
|
(58
|
)%
|
|
(29
|
)%
|
|||
Total revenue
|
$
|
1,369
|
|
|
$
|
94,370
|
|
|
$
|
47,720
|
|
|
(99
|
)%
|
|
98
|
%
|
|
Year ended December 31,
|
||||||||||
|
2013
|
|
2012
|
|
2011
|
||||||
Profit equalization revenue
(1)
|
$
|
5
|
|
|
$
|
26,544
|
|
|
$
|
—
|
|
Milestone payments
|
—
|
|
|
60,250
|
|
|
10,000
|
|
|||
Revenue previously deferred related to API
|
—
|
|
|
936
|
|
|
—
|
|
|||
Revenue recognized under CAPM
|
—
|
|
|
—
|
|
|
26,606
|
|
|||
Net expense reimbursement after CAPM
|
1,364
|
|
|
6,628
|
|
|
11,097
|
|
|||
Total collaboration revenue
|
$
|
1,369
|
|
|
$
|
94,358
|
|
|
$
|
47,703
|
|
|
Year ended December 31,
|
||||||||||
|
2013
|
|
2012
|
|
2011
|
||||||
Research & development
|
$
|
525
|
|
|
$
|
15,480
|
|
|
$
|
22,412
|
|
Selling, general & administrative
|
—
|
|
|
43,748
|
|
|
8,471
|
|
|||
Total
|
$
|
525
|
|
|
$
|
59,228
|
|
|
$
|
30,883
|
|
|
Year ended December 31,
|
|
Percent Change
|
||||||||||||
|
2013
|
|
2012
|
|
2011
|
|
2012/2011
|
|
2011/2010
|
||||||
Impairment of inventory and losses on firm purchase commitments
|
$
|
—
|
|
|
$
|
44,957
|
|
|
$
|
—
|
|
|
N/A
|
|
N/A
|
|
Year ended December 31,
|
|
Percent Change
|
||||||||||
|
2013
|
|
2012
|
|
2011
|
|
2013/2012
|
|
2012/2011
|
||||
Collaboration cost reimbursement
|
$(43,451)
|
|
$
|
—
|
|
|
$
|
—
|
|
|
N/A
|
|
N/A
|
|
Year ended December 31,
|
|
Percent Change
|
||||||||||||||
|
2013
|
|
2012
|
|
2011
|
|
2013/2012
|
|
2012/2011
|
||||||||
Research and development expenses
|
$
|
11,857
|
|
|
$
|
51,738
|
|
|
$
|
76,308
|
|
|
(77
|
)%
|
|
(32
|
)%
|
|
Year ended December 31,
|
|
Percent Change
|
||||||||||||||
|
2013
|
|
2012
|
|
2011
|
|
2013/2012
|
|
2012/2011
|
||||||||
Selling, general and administrative expenses
|
$
|
27,529
|
|
|
$
|
89,714
|
|
|
$
|
32,818
|
|
|
(69
|
)%
|
|
173
|
%
|
|
Year ended December 31,
|
|
Percent Change
|
||||||||||||
|
2013
|
|
2012
|
|
2011
|
|
2013/2012
|
|
2012/2011
|
||||||
Impairment (gain on disposal) of prepaid expenses, fixed assets and intangible assets
|
$
|
4,414
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
N/A
|
|
N/A
|
|
Year ended December 31,
|
|
Percent Change
|
||||||||||||
|
2013
|
|
2012
|
|
2011
|
|
2013/2012
|
|
2012/2011
|
||||||
Restructuring charges
|
$
|
16,066
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
N/A
|
|
N/A
|
|
Year ended December 31,
|
|
Percent Change
|
||||||||||||||
|
2013
|
|
2012
|
|
2011
|
|
2013/2012
|
|
2012/2011
|
||||||||
Interest income
|
$
|
21
|
|
|
$
|
77
|
|
|
$
|
169
|
|
|
(73
|
)%
|
|
(54
|
)%
|
Interest expense
|
$
|
(1,565
|
)
|
|
$
|
(1,442
|
)
|
|
$
|
(144
|
)
|
|
9
|
%
|
|
901
|
%
|
Interest income (expense), net
|
$
|
(1,544
|
)
|
|
$
|
(1,365
|
)
|
|
$
|
25
|
|
|
13
|
%
|
|
(5,560
|
)%
|
|
Year ended December 31,
|
|
Percent Change
|
||||||||||||||
|
2013
|
|
2012
|
|
2011
|
|
2013/2012
|
|
2012/2011
|
||||||||
Other income (expense), net
|
$
|
8
|
|
|
$
|
(34
|
)
|
|
$
|
15
|
|
|
(124
|
)%
|
|
(327
|
)%
|
|
December 31,
|
||||
|
2013
|
|
2012
|
||
Cash and cash equivalents
|
$5,597
|
|
$68,265
|
||
Short-term investments
|
—
|
|
|
9,717
|
|
Long-term investments
|
—
|
|
|
2,323
|
|
|
December 31,
|
||||||||||
|
2013
|
|
2012
|
|
2011
|
||||||
Net cash used in operating activities
|
$
|
(67,339
|
)
|
|
$
|
(37,180
|
)
|
|
$
|
(71,966
|
)
|
Net cash provided by (used in) investing activities
|
14,400
|
|
|
27,995
|
|
|
8,001
|
|
|||
Net cash provided by (used in) financing activities
|
(9,729
|
)
|
|
23,111
|
|
|
54,805
|
|
|
Payments Due by Period
|
||||||||||||||||||
Contractual Obligations
|
Total
|
|
2014
|
|
2015 -2016
|
|
2017 -2018
|
|
Thereafter
|
||||||||||
Operating lease obligations
|
$
|
23
|
|
|
$
|
23
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Total fixed contractual obligations
|
$
|
23
|
|
|
$
|
23
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
|
|
Page
|
Report of Independent Registered Public Accounting Firm
|
|
Balance Sheets as of December 31, 2013 and 2012
|
|
Statements of Operations for the years ended December 31, 2013, 2012, and 2011
|
|
Statements of Comprehensive Loss for the years ended December 31, December 31, 2013, 2012, and 2011
|
|
Statements of Stockholders' Equity (Deficit) for the years ended December 31, 2013, 2012, and 2011
|
|
Statements of Cash Flows for the years ended December 31, December 31, 2013, 2012, and 2011
|
|
Notes to Financial Statements
|
|
|
|
|
|
/s/ Ernst & Young LLP
|
|
December 31,
|
||||||
|
2013
|
|
2012
|
||||
Assets
|
|
|
|
|
|
||
Current assets
|
|
|
|
|
|
||
Cash and cash equivalents
|
$
|
5,597
|
|
|
$
|
68,265
|
|
Short-term investments
|
—
|
|
|
9,717
|
|
||
Receivable from Takeda
|
—
|
|
|
18,365
|
|
||
Deferred tax assets
|
—
|
|
|
363
|
|
||
Prepaid expenses
|
725
|
|
|
2,731
|
|
||
Other current assets
|
—
|
|
|
3,069
|
|
||
Total current assets
|
6,322
|
|
|
102,510
|
|
||
Property and equipment, net
|
—
|
|
|
2,981
|
|
||
Restricted cash
|
—
|
|
|
1,135
|
|
||
Long-term investments
|
—
|
|
|
2,323
|
|
||
Deferred tax assets, net of current
|
—
|
|
|
6,876
|
|
||
Other assets
|
1,121
|
|
|
2,392
|
|
||
Total assets
|
$
|
7,443
|
|
|
$
|
118,217
|
|
Liabilities and Stockholders’ Equity (Deficit)
|
|
|
|
|
|
||
Current liabilities
|
|
|
|
|
|
||
Accounts payable
|
$
|
101
|
|
|
$
|
6,591
|
|
Accrued liabilities
|
581
|
|
|
52,522
|
|
||
Accrued clinical trial expenses
|
—
|
|
|
2,844
|
|
||
Deposit from Takeda
|
—
|
|
|
559
|
|
||
Advance from Takeda
|
8,189
|
|
|
27,715
|
|
||
Notes payable, current
|
—
|
|
|
8,844
|
|
||
Total current liabilities
|
8,871
|
|
|
99,075
|
|
||
Long-term income tax liability
|
—
|
|
|
10,062
|
|
||
Other long-term liabilities
|
—
|
|
|
799
|
|
||
Total liabilities
|
8,871
|
|
|
109,936
|
|
||
Commitments and contingencies
(Note 9)
|
|
|
|
||||
Stockholders’ equity (deficit)
|
|
|
|
|
|
||
Preferred stock, $0.001 par value, 10,000,000 shares authorized, none issued and outstanding
|
—
|
|
|
—
|
|
||
Common stock: $0.001 par value, 100,000,000 shares authorized, 37,490,095 and 37,396,717 shares issued and outstanding at December 31, 2013 and 2012, respectively
|
37
|
|
|
37
|
|
||
Additional paid-in capital
|
556,672
|
|
|
551,959
|
|
||
Accumulated deficit
|
(558,137
|
)
|
|
(543,713
|
)
|
||
Accumulated other comprehensive income
|
—
|
|
|
(2
|
)
|
||
Total stockholders’ equity (deficit)
|
(1,428
|
)
|
|
8,281
|
|
||
Total liabilities and stockholders’ equity (deficit)
|
$
|
7,443
|
|
|
$
|
118,217
|
|
|
Year Ended December 31,
|
||||||||||
|
2013
|
|
2012
|
|
2011
|
||||||
Revenue:
|
|
|
|
|
|
|
|
||||
Collaboration revenue
|
$
|
1,364
|
|
|
$
|
94,358
|
|
|
$
|
47,703
|
|
License and royalty revenue
|
5
|
|
|
12
|
|
|
17
|
|
|||
Total revenue
|
1,369
|
|
|
94,370
|
|
|
47,720
|
|
|||
Operating expenses:
|
|
|
|
|
|
|
|
||||
Impairment of inventory and losses on firm purchase commitments
|
—
|
|
|
44,957
|
|
|
—
|
|
|||
Research and development
|
11,857
|
|
|
51,738
|
|
|
76,308
|
|
|||
Selling, general and administrative
|
27,529
|
|
|
89,714
|
|
|
32,818
|
|
|||
Collaboration cost reimbursement
|
(43,451
|
)
|
|
—
|
|
|
—
|
|
|||
Impairment (gain on disposal) of prepaid expenses, fixed assets and intangible assets
|
4,414
|
|
|
—
|
|
|
—
|
|
|||
2013 Restructuring charge
|
16,066
|
|
|
—
|
|
|
—
|
|
|||
Total operating expenses
|
16,415
|
|
|
186,409
|
|
|
109,126
|
|
|||
Loss from operations
|
(15,046
|
)
|
|
(92,039
|
)
|
|
(61,406
|
)
|
|||
Interest income
|
21
|
|
|
77
|
|
|
169
|
|
|||
Interest expense
|
(1,565
|
)
|
|
(1,442
|
)
|
|
(144
|
)
|
|||
Other income (expense), net
|
8
|
|
|
(34
|
)
|
|
15
|
|
|||
Loss before provision (benefit) for income taxes
|
(16,582
|
)
|
|
(93,438
|
)
|
|
(61,366
|
)
|
|||
Provision (benefit) for income taxes
|
(2,158
|
)
|
|
(26
|
)
|
|
1
|
|
|||
Net loss
|
$
|
(14,424
|
)
|
|
$
|
(93,412
|
)
|
|
$
|
(61,367
|
)
|
Net loss per share:
|
|
|
|
|
|
||||||
Basic and diluted
|
$
|
(0.39
|
)
|
|
$
|
(2.57
|
)
|
|
$
|
(1.84
|
)
|
Weighted-average number of shares used in computing basic and diluted net loss per share
|
37,448
|
|
|
36,342
|
|
|
33,288
|
|
|
Year Ended December 31,
|
||||||||||
|
2013
|
|
2012
|
|
2011
|
||||||
Net loss
|
$
|
(14,424
|
)
|
|
$
|
(93,412
|
)
|
|
$
|
(61,367
|
)
|
Other comprehensive loss:
|
|
|
|
|
|
||||||
Change in unrealized gains (losses) on investments
|
2
|
|
|
(20
|
)
|
|
(13
|
)
|
|||
Other comprehensive loss
|
2
|
|
(20)
|
|
(13)
|
||||||
Comprehensive loss
|
$
|
(14,422
|
)
|
|
$
|
(93,432
|
)
|
|
$
|
(61,380
|
)
|
|
|
|
Additional
Paid-In
Capital
|
|
Deferred
Stock-Based
Compensation
|
|
Accumulated
Deficit
|
|
Accumulated Other Comprehensive Income (Loss)
|
|
Total Stockholder's Equity
|
|||||||||||||||
|
Shares
|
|
Amount
|
|
||||||||||||||||||||||
Balance at December 31, 2010
|
25,451,338
|
|
|
$
|
25
|
|
|
$
|
461,425
|
|
|
$
|
—
|
|
|
$
|
(388,934
|
)
|
|
$
|
31
|
|
|
$
|
72,547
|
|
Issuance of common stock upon exercise of stock options
|
95,917
|
|
|
—
|
|
|
371
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
371
|
|
||||||
Issuance of common stock upon vesting of restricted stock units
|
255,782
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Proceeds from common stock issued upon public offering, net of issuance costs
|
9,745,762
|
|
|
10
|
|
|
53,615
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
53,625
|
|
||||||
Issuance of common stock related to the employee stock purchase plan
|
184,382
|
|
|
1
|
|
|
807
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
808
|
|
||||||
Deferred stock-based compensation
|
—
|
|
|
—
|
|
|
(5
|
)
|
|
5
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Amortization of deferred stock-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
(5
|
)
|
|
—
|
|
|
—
|
|
|
(5
|
)
|
||||||
Employee stock-based compensation
|
—
|
|
|
—
|
|
|
9,773
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
9,773
|
|
||||||
Nonemployee stock-based compensation related to consultants
|
—
|
|
|
—
|
|
|
(10
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(10
|
)
|
||||||
Nonemployee stock-based compensation related to former CEO
|
—
|
|
|
—
|
|
|
268
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
268
|
|
||||||
Change in unrealized loss on marketable securities
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(13
|
)
|
|
(13
|
)
|
||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(61,367
|
)
|
|
—
|
|
|
(61,367
|
)
|
||||||
Balance at December 31, 2011
|
35,733,181
|
|
|
36
|
|
|
526,244
|
|
|
—
|
|
|
(450,301
|
)
|
|
18
|
|
|
75,997
|
|
||||||
Issuance of common stock upon exercise of stock options
|
1,129,422
|
|
|
1
|
|
|
12,028
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
12,029
|
|
||||||
Issuance of common stock upon vesting of restricted stock units
|
222,093
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Issuance of common stock related to the employee stock purchase plan
|
224,908
|
|
|
—
|
|
|
1,082
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,082
|
|
||||||
Issuance of warrants related to Loan and Security Agreement
|
—
|
|
|
—
|
|
|
1,394
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,394
|
|
||||||
Issuance of common stock upon net exercise of warrants
|
60,113
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Deferred stock-based compensation
|
—
|
|
|
—
|
|
|
87
|
|
|
(87
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Amortization of deferred stock-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
87
|
|
|
—
|
|
|
—
|
|
|
87
|
|
||||||
Employee stock-based compensation
|
—
|
|
|
—
|
|
|
11,055
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
11,055
|
|
||||||
Nonemployee stock-based compensation
|
—
|
|
|
—
|
|
|
69
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
69
|
|
||||||
Change in unrealized loss on marketable securities
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(20
|
)
|
|
(20
|
)
|
||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(93,412
|
)
|
|
—
|
|
|
(93,412
|
)
|
||||||
Balance at December 31, 2012
|
37,369,717
|
|
|
37
|
|
|
551,959
|
|
|
—
|
|
|
(543,713
|
)
|
|
(2
|
)
|
|
8,281
|
|
||||||
Issuance of common stock upon exercise of stock options
|
30,918
|
|
|
—
|
|
|
271
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
271
|
|
||||||
Issuance of common stock upon vesting of restricted stock units
|
89,460
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Deferred stock-based compensation
|
—
|
|
|
—
|
|
|
(3
|
)
|
|
3
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||
Amortization of deferred stock-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
(3
|
)
|
|
—
|
|
|
—
|
|
|
(3
|
)
|
||||||
Employee stock-based compensation
|
—
|
|
|
—
|
|
|
4,445
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
4,445
|
|
||||||
Change in unrealized loss on marketable securities
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2
|
|
|
2
|
|
||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(14,424
|
)
|
|
—
|
|
|
(14,424
|
)
|
||||||
Balance at December 31, 2013
|
37,490,095
|
|
|
$
|
37
|
|
|
$
|
556,672
|
|
|
$
|
—
|
|
|
$
|
(558,137
|
)
|
|
$
|
—
|
|
|
$
|
(1,428
|
)
|
|
Year ended December 31,
|
||||||||||
|
2013
|
|
2012
|
|
2011
|
||||||
Cash flows from operating activities
|
|
|
|
|
|
|
|
||||
Net loss
|
$
|
(14,424
|
)
|
|
$
|
(93,412
|
)
|
|
$
|
(61,367
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
|
|
||||
Collaboration cost reimbursement
|
(43,451
|
)
|
|
—
|
|
|
—
|
|
|||
Impairment of prepaid expenses, fixed assets and intangible assets
|
5,118
|
|
|
—
|
|
|
—
|
|
|||
Noncash restructuring charge
|
307
|
|
|
—
|
|
|
—
|
|
|||
Impairment of inventory and losses on firm purchase commitments
|
—
|
|
|
44,957
|
|
|
—
|
|
|||
Depreciation and amortization
|
722
|
|
|
1,987
|
|
|
2,182
|
|
|||
Amortization of premium on investments
|
1
|
|
|
75
|
|
|
55
|
|
|||
Stock-based compensation expense
|
4,442
|
|
|
11,211
|
|
|
10,025
|
|
|||
Loss on (gain) on disposal of property and equipment
|
(704
|
)
|
|
30
|
|
|
11
|
|
|||
Noncash interest expense
|
811
|
|
|
827
|
|
|
144
|
|
|||
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
||||
Receivable from Takeda
|
18,365
|
|
|
(9,600
|
)
|
|
(6,937
|
)
|
|||
Inventory
|
—
|
|
|
(4,515
|
)
|
|
—
|
|
|||
Prepaid expenses
|
(441
|
)
|
|
(5,085
|
)
|
|
272
|
|
|||
Other current assets
|
3,028
|
|
|
(2,732
|
)
|
|
(77
|
)
|
|||
Other noncurrent assets
|
73
|
|
|
(2
|
)
|
|
(289
|
)
|
|||
Accounts payable
|
(6,490
|
)
|
|
5,650
|
|
|
620
|
|
|||
Accrued liabilities
|
(28,335
|
)
|
|
3,849
|
|
|
2,405
|
|
|||
Accrued clinical trial expenses
|
(2,844
|
)
|
|
(521
|
)
|
|
(7,882
|
)
|
|||
Payable to Takeda
|
—
|
|
|
—
|
|
|
(5,958
|
)
|
|||
Deferred revenue
|
—
|
|
|
(5,174
|
)
|
|
(13,322
|
)
|
|||
Deposit from Takeda
|
(559
|
)
|
|
(1,438
|
)
|
|
1,998
|
|
|||
Long-term income tax liability
|
(2,159
|
)
|
|
(27
|
)
|
|
18
|
|
|||
Advance from Takeda
|
—
|
|
|
17,767
|
|
|
6,121
|
|
|||
Other long-term liabilities
|
(799
|
)
|
|
(1,027
|
)
|
|
15
|
|
|||
Net cash used in operating activities
|
(67,339
|
)
|
|
(37,180
|
)
|
|
(71,966
|
)
|
|||
Cash flows from investing activities
|
|
|
|
|
|
|
|
||||
Purchases of property and equipment
|
—
|
|
|
(1,562
|
)
|
|
(1,265
|
)
|
|||
Payments for of intellectual property license
|
—
|
|
|
(2,500
|
)
|
|
—
|
|
|||
Purchases of investments
|
—
|
|
|
(13,233
|
)
|
|
(35,799
|
)
|
|||
Proceeds from sale of investments
|
13,175
|
|
|
—
|
|
|
—
|
|
|||
Proceeds from maturities of investments and restricted cash
|
—
|
|
|
45,265
|
|
|
45,024
|
|
|||
Proceeds from sale of property and equipment
|
1,225
|
|
|
25
|
|
|
41
|
|
|||
Net cash provided by investing activities
|
14,400
|
|
|
27,995
|
|
|
8,001
|
|
|||
Cash flows from financing activities
|
|
|
|
|
|
|
|
||||
Proceeds from issuance of common stock upon exercise of stock options
|
271
|
|
|
12,029
|
|
|
371
|
|
|||
Proceeds from issuance of common stock under employee stock purchase plan
|
—
|
|
|
1,082
|
|
|
809
|
|
|||
Proceeds from common stock issued upon private placement, net of issuance costs
|
—
|
|
|
—
|
|
|
—
|
|
|||
Proceeds from common stock issued upon public offering, net of issuance costs
|
—
|
|
|
—
|
|
|
53,625
|
|
|||
Repayment of notes payable
|
(10,000
|
)
|
|
—
|
|
|
—
|
|
|||
Proceeds from notes payable
|
—
|
|
|
10,000
|
|
|
—
|
|
|||
Net cash provided by (used in) financing activities
|
(9,729
|
)
|
|
23,111
|
|
|
54,805
|
|
|||
Net increase (decrease) in cash and cash equivalents
|
(62,668
|
)
|
|
13,926
|
|
|
(9,160
|
)
|
|||
Cash and cash equivalents at beginning of the period
|
68,265
|
|
|
54,339
|
|
|
63,499
|
|
|||
Cash and cash equivalents at end of the period
|
$
|
5,597
|
|
|
$
|
68,265
|
|
|
$
|
54,339
|
|
Supplemental disclosures of cash flow information:
|
|
|
|
|
|
||||||
Income taxes paid
|
$
|
1
|
|
|
$
|
1
|
|
|
$
|
1
|
|
Interest paid
|
$
|
792
|
|
|
$
|
615
|
|
|
$
|
—
|
|
Supplemental schedule of non-cash financing activities:
|
|
|
|
|
|
|
|
||||
Advance from Takeda
|
$
|
—
|
|
|
$
|
1,828
|
|
|
$
|
—
|
|
Change in unrealized gain (loss) on investments
|
$
|
2
|
|
|
$
|
(20
|
)
|
|
$
|
(13
|
)
|
Deferred stock-based compensation, net of cancellations
|
$
|
3
|
|
|
$
|
87
|
|
|
$
|
(5
|
)
|
Warrants issued in connection with notes payable
|
$
|
—
|
|
|
$
|
1,394
|
|
|
$
|
—
|
|
•
|
Expense reimbursement revenue.
Revenues related to reimbursements by Takeda of third-party development expenses (70/30 split per the Arrangement) and commercialization expenses (shared 50/50 according to the Arrangement) are recognized as revenue in the period the related costs are incurred. Revenues related to reimbursement of costs of full-time equivalents, or FTEs, engaged in development related activities such as post-
|
•
|
Profit equalization revenue/loss.
Subsequent to the launch of OMONTYS and prior to the Amendment, as to the recognition of product revenue by Takeda, Takeda allocates the quarterly profit equalization revenue/loss to us in order to effect the 50/50 profit/loss split from the sale of OMONTYS, as called for by the Arrangement. Profit equalization revenue/loss is calculated as the amount required so that the profit or loss realized by both us and Takeda on the product equates to
50%
of the total product profit or loss. Total product profit or loss on OMONTYS is calculated on a quarterly basis as gross product sales recorded by Takeda less the following deductions also recorded by Takeda: rebates and discounts, cost of goods, and other gross-to-net adjustments incurred by Takeda; royalty expenses incurred by us, commercialization expenses (FTE related and out of pocket costs) incurred by both Takeda and us, and certain development costs associated with post-marketing development activities (FTE related and out of pocket costs) incurred by both Takeda and us. Profit equalization revenue is recognized as revenue in the period product revenue is recognized by Takeda. As a result of the voluntary recall of OMONTYS in February 2013, all marketing activities were suspended. As part of the Amendment with Takeda, the profit equalization revenue for the three months ended March 31, 2013 will be the final profit equalization payment under the Arrangement. Upon signing the Amendment with Takeda, the economics of the collaboration changed from a profit sharing arrangement to a milestone and royalty-based compensation structure to us, effective April 1, 2013.
|
•
|
Milestone revenue.
We account for milestones under ASU No. 2010-17,
Milestone Method of Revenue Recognition
. Under the milestone method, contingent consideration received from the achievement of a substantive milestone is recognized in its entirety in the period in which the milestone is achieved, which we believe is more consistent with the substance of our performance under the collaboration. A milestone is defined as an event (i) that can only be achieved based in whole or in part on either the entity’s performance or on the occurrence of a specific outcome resulting from the entity’s performance, (ii) for which there is substantive uncertainty at the date the arrangement is entered into that the event will be achieved, and (iii) that would result in additional payments being due to the entity. A milestone is substantive if the consideration earned from the achievement of the milestone is consistent with our performance required to achieve the milestone or the increase in value to the collaboration resulting from our performance, relates solely to our past performance, and is reasonable relative to all of the other deliverables and payments within the collaboration. Although we are eligible to receive future milestones from Takeda, timing and amounts of future milestone payments, if any are extremely uncertain due to the recall.
|
|
Year ended December 31,
|
||||||||||
|
2013
|
|
2012
|
|
2011
|
||||||
Profit equalization revenue
|
$
|
5
|
|
|
$
|
26,544
|
|
|
$
|
—
|
|
Milestone payments
|
—
|
|
|
60,250
|
|
|
10,000
|
|
|||
Revenue previously deferred related to API
|
—
|
|
|
936
|
|
|
—
|
|
|||
Revenue recognized under CAPM
|
—
|
|
|
—
|
|
|
26,606
|
|
|||
Net expense reimbursement after CAPM
|
1,364
|
|
|
6,628
|
|
|
11,097
|
|
|||
Total collaboration revenue
|
$
|
1,369
|
|
|
$
|
94,358
|
|
|
$
|
47,703
|
|
|
Year ended December 31,
|
||||||||||
|
2013
|
|
2012
|
|
2011
|
||||||
Numerator:
|
|
|
|
|
|
||||||
Net loss
|
$
|
(14,424
|
)
|
|
$
|
(93,412
|
)
|
|
$
|
(61,367
|
)
|
Denominator:
|
|
|
|
|
|
||||||
Weighted-average number of common shares used in computing basic and diluted net loss per common share
|
37,448
|
|
|
36,342
|
|
|
33,288
|
|
|||
Basic and diluted net loss per common share
|
$
|
(0.39
|
)
|
|
$
|
(2.57
|
)
|
|
$
|
(1.84
|
)
|
|
Year ended December 31,
|
|||||||
|
2013
|
|
2012
|
|
2011
|
|||
Options to purchase common stock
|
1,840
|
|
|
4,858
|
|
|
4,262
|
|
Common stock issuable pursuant to the 2006 Employee Stock Purchase Plan
|
—
|
|
|
40
|
|
|
41
|
|
Restricted stock units
|
—
|
|
|
297
|
|
|
362
|
|
Warrant to purchase common stock
|
424
|
|
|
424
|
|
|
426
|
|
|
December 31,
|
||||||
|
2013
|
|
2012
|
||||
Leasehold improvements
|
$
|
—
|
|
|
$
|
2,501
|
|
Equipment
|
—
|
|
|
9,794
|
|
||
Software
|
—
|
|
|
3,064
|
|
||
Construction in progress
|
—
|
|
|
9
|
|
||
|
—
|
|
|
15,368
|
|
||
Less: Accumulated depreciation and amortization
|
—
|
|
|
(12,387
|
)
|
||
|
$
|
—
|
|
|
$
|
2,981
|
|
|
December 31,
|
||||||
|
2013
|
|
2012
|
||||
Accrued potential losses related to firm purchase commitments
|
$
|
—
|
|
|
$
|
34,599
|
|
Restructuring accrual
|
315
|
|
|
—
|
|
||
Compensation-related expenses
|
—
|
|
|
12,837
|
|
||
SG&A related costs
|
266
|
|
|
3,633
|
|
||
R&D related costs
|
—
|
|
|
830
|
|
||
Other
|
—
|
|
|
623
|
|
||
|
$
|
581
|
|
|
$
|
52,522
|
|
|
As of December 31, 2012
|
||||||||||||||
|
Cost
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
Losses
|
|
Fair Value
|
||||||||
Short-term investments:
|
|
|
|
|
|
|
|
|
|
|
|
||||
Certificates of deposit
|
$
|
1,300
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,300
|
|
Corporate debt securities
|
8,416
|
|
|
1
|
|
|
—
|
|
|
8,417
|
|
||||
Total short-term investments
|
$
|
9,716
|
|
|
$
|
1
|
|
|
$
|
—
|
|
|
$
|
9,717
|
|
|
|
|
|
|
|
|
|
||||||||
Long-term investments:
|
|
|
|
|
|
|
|
||||||||
Corporate debt securities
|
$
|
2,326
|
|
|
$
|
—
|
|
|
$
|
(3
|
)
|
|
$
|
2,323
|
|
Total long-term investments
|
$
|
2,326
|
|
|
$
|
—
|
|
|
$
|
(3
|
)
|
|
$
|
2,323
|
|
|
|
•
|
Level 1 — observable inputs such as quoted prices in active markets.
|
•
|
Level 2 — inputs other than quoted prices in active markets that are observable either directly or indirectly through corroboration with observable market data.
|
•
|
Level 3 — unobservable inputs in which there is little or no market data, which would require us to develop our own assumptions.
|
|
As of December 31, 2012
|
||||||||||||||
|
|
|
Fair Value Measurements Using
|
||||||||||||
|
Total
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||||
Money market funds
|
$
|
45,999
|
|
|
$
|
45,999
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Short-term investments:
|
|
|
|
|
|
|
|
|
|
|
|
||||
Certificates of deposit
|
$
|
1,300
|
|
|
$
|
—
|
|
|
$
|
1,300
|
|
|
$
|
—
|
|
Corporate debt securities
|
8,417
|
|
|
—
|
|
|
8,417
|
|
|
—
|
|
||||
Total short-term investments
|
$
|
9,717
|
|
|
$
|
—
|
|
|
$
|
9,717
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
||||||||
Long term investments:
|
|
|
|
|
|
|
|
||||||||
Corporate debt securities
|
$
|
2,323
|
|
|
$
|
—
|
|
|
$
|
2,323
|
|
|
$
|
—
|
|
Total long-term investments
|
$
|
2,323
|
|
|
$
|
—
|
|
|
$
|
2,323
|
|
|
$
|
—
|
|
2014
|
23
|
|
|
Total minimum lease payments
|
$
|
23
|
|
|
Year ended December 31,
|
||||||||||
|
2013
|
|
2012
|
|
2011
|
||||||
Research and development
|
$
|
878
|
|
|
$
|
4,324
|
|
|
$
|
4,632
|
|
Selling, general and administrative
|
3,564
|
|
|
6,887
|
|
|
5,393
|
|
|||
Total
|
$
|
4,442
|
|
|
$
|
11,211
|
|
|
$
|
10,025
|
|
|
Year ended December 31,
|
|||||||||||||||||||
|
2013
|
|
2012
|
|
2011
|
|||||||||||||||
|
Number of
Shares
|
|
Weighted-
Average Grant
Date Fair Value
Per Share
|
|
Number of
Shares
|
|
Weighted-
Average Grant
Date Fair Value
Per Share
|
|
Number of
Shares
|
|
Weighted-
Average Grant
Date Fair Value
Per Share
|
|||||||||
Stock options
|
888,778
|
|
|
$
|
15.79
|
|
|
2,142,286
|
|
|
$
|
8.26
|
|
|
1,110,924
|
|
|
$
|
4.41
|
|
Restricted stock units
|
393,195
|
|
|
$
|
16.36
|
|
|
184,963
|
|
|
$
|
7.99
|
|
|
220,856
|
|
|
$
|
6.96
|
|
|
Year ended December 31,
|
|||||||
|
2013
|
|
2012
|
|
2011
|
|||
Expected volatility
|
120
|
%
|
|
81
|
%
|
|
80
|
%
|
Risk-free interest rate
|
0.77
|
%
|
|
0.89
|
%
|
|
1.86
|
%
|
Dividend yield
|
0.00
|
%
|
|
0.00
|
%
|
|
0.00
|
%
|
Expected term (in years)
|
5.4
|
|
|
5.5
|
|
|
5.6
|
|
|
Year ended December 31,
|
||||
|
2013
|
|
2012
|
|
2011
|
Expected volatility
|
—%
|
|
50%-106%
|
|
50%-157%
|
Risk-free interest rate
|
—%
|
|
0.04%-0.57%
|
|
0.04%-1.00%
|
Dividend yield
|
—%
|
|
—%
|
|
—%
|
Expected term (in months)
|
—
|
|
6-24
|
|
6-24
|
|
Number of
Shares
|
|
Weighted-
Average Exercise Price
(Per Share)(1)
|
|
Weighted-
Average
Remaining
Contractual
Term
(in years)
|
|
Aggregate
Intrinsic Value
(in thousands)(2)
|
|||||
Stock Options:
|
|
|
|
|
|
|
|
|||||
Balances at December 31, 2012
|
4,857,536
|
|
|
$
|
13.49
|
|
|
|
|
|
|
|
Granted
|
888,778
|
|
|
18.83
|
|
|
|
|
|
|
||
Exercised (3)
|
(30,918
|
)
|
|
8.77
|
|
|
|
|
|
|
||
Forfeited
|
(2,889,025
|
)
|
|
13.35
|
|
|
|
|
|
|
||
Cancelled
|
(986,514
|
)
|
|
13.74
|
|
|
|
|
|
|
||
Balances at December 31, 2013
|
1,839,857
|
|
|
$
|
16.24
|
|
|
3.56
|
|
$
|
—
|
|
Options exercisable at
December 31, 2013 |
1,551,929
|
|
|
$
|
17.06
|
|
|
2.76
|
|
$
|
—
|
|
Options vested and expected to vest at December 31, 2013
|
1,834,691
|
|
|
$
|
16.24
|
|
|
3.55
|
|
$
|
—
|
|
|
Number of
Shares
|
|
Weighted-
Average Grant Date Fair Value
(Per Share)(1)
|
|
Weighted-
Average
Remaining
Contractual
Term
(in years)
|
|
Aggregate
Intrinsic Value
(in thousands)(2)
|
||||||
Restricted Stock Units:
|
|
|
|
|
|
|
|
||||||
Balances at December 31, 2012
|
296,723
|
|
|
$
|
7.54
|
|
|
|
|
|
|
|
|
Granted (time-based)
|
393,195
|
|
|
16.36
|
|
|
|
|
|
|
|
||
Vested
|
(89,460
|
)
|
|
7.58
|
|
|
|
|
|
|
|
||
Forfeited
|
(600,458
|
)
|
|
—
|
|
|
|
|
|
|
|
||
Balances at December 31, 2013
|
—
|
|
|
$
|
—
|
|
|
—
|
|
|
$
|
—
|
|
(1)
|
The weighted average price per share is determined using exercise price per share for stock options and fair value per share on grant date for restricted stock units.
|
(2)
|
The aggregate intrinsic value is calculated as:
|
•
|
For options: the difference between the exercise price of the option and the fair value of our common stock for in-the-money options at
December 31, 2013
.
|
•
|
For restricted stock units: the difference between the grant date fair value of the unit and the fair value of our common stock for in-the-money units at
December 31, 2013
.
|
(3)
|
The total intrinsic value of stock options exercised was $
0.3 million
, $
10.6 million
, and $
0.3 million
during the years ended
December 31, 2013
,
2012
, and
2011
, respectively, and was determined at the date of each exercise.
|
|
Stock Options Outstanding
|
|
Stock Options Exercisable
|
||||||||
Range of Exercise Prices
|
Number of
Shares
|
|
Weighted-
Average
Remaining
Contractual
Life in Years
|
|
Weighted-
Average
Exercise
Price Per Share
|
|
Number of
Shares
|
|
Weighted-
Average
Exercise
Price Per Share
|
||
$0.80 - 10.99
|
728,358
|
|
|
8.21
|
|
$7.31
|
|
542,799
|
|
|
$7.32
|
$11.00 - 20.22
|
417,558
|
|
|
8.12
|
|
$16.87
|
|
333,921
|
|
|
$16.23
|
$20.23 - 32.89
|
583,246
|
|
|
6.81
|
|
$23.56
|
|
564,509
|
|
|
$23.59
|
$32.90 - 33.97
|
110,700
|
|
|
3.78
|
|
$33.97
|
|
110,700
|
|
|
$33.97
|
$0.80 - 33.97
|
1,839,862
|
|
|
7.73
|
|
$16.23
|
|
1,551,929
|
|
|
$17.06
|
|
Facilities
Related
|
|
Employee
Related
|
|
Total
|
||||||
Balance as of January 1, 2011
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Restructuring charge accrued
|
869
|
|
|
975
|
|
|
1,844
|
|
|||
Cash payments
|
(431)
|
|
|
(710)
|
|
|
(1,141)
|
|
|||
Accretion
|
72
|
|
|
—
|
|
|
72
|
|
|||
Balance as of January 1, 2012
|
510
|
|
|
265
|
|
|
775
|
|
|||
Restructuring charge accrued
|
77
|
|
|
6
|
|
|
83
|
|
|||
Adjustments
|
(413
|
)
|
|
(62
|
)
|
|
(475
|
)
|
|||
Cash payments
|
(214
|
)
|
|
(209
|
)
|
|
(423
|
)
|
|||
Accretion
|
11
|
|
|
—
|
|
|
11
|
|
|||
Balance as of December 31, 2012
|
(29
|
)
|
|
—
|
|
|
(29
|
)
|
|||
Adjustments
|
29
|
|
|
—
|
|
|
29
|
|
|||
Balance at December 31, 2013
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
Facilities
Related
|
|
Employee
Related
|
|
Total
|
||||||
Balance as of December 31, 2012
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Restructuring charges accrued
|
2,500
|
|
|
14,766
|
|
|
17,266
|
|
|||
Adjustments
|
—
|
|
|
(1,200
|
)
|
|
(1,200
|
)
|
|||
Cash payments
|
(2,500
|
)
|
|
(13,251
|
)
|
|
(15,751
|
)
|
|||
Balance at December 31, 2013
|
$
|
—
|
|
|
$
|
315
|
|
|
$
|
315
|
|
|
Year ended December 31,
|
||||||||||
|
2013
|
|
2012
|
|
2011
|
||||||
Provision (benefit) for income taxes:
|
|
|
|
|
|
||||||
Current provision (benefit) for income taxes:
|
|
|
|
|
|
||||||
Federal
|
$
|
(26
|
)
|
|
$
|
(27
|
)
|
|
$
|
—
|
|
State
|
(2,132
|
)
|
|
1
|
|
|
1
|
|
|||
Total current provision (benefit) for income taxes
|
(2,158
|
)
|
|
(26
|
)
|
|
1
|
|
|||
Deferred tax benefit:
|
|
|
|
|
|
||||||
Federal
|
—
|
|
|
—
|
|
|
—
|
|
|||
State
|
—
|
|
|
—
|
|
|
—
|
|
|||
Total deferred tax benefit
|
—
|
|
|
—
|
|
|
—
|
|
|||
Provision (benefit) for income taxes
|
$
|
(2,158
|
)
|
|
$
|
(26
|
)
|
|
$
|
1
|
|
|
Year ended December 31,
|
|||||||
|
2013
|
|
2012
|
|
2011
|
|||
Federal statutory income tax rate
|
(35.00
|
)%
|
|
(35.00
|
)%
|
|
(35.00
|
)%
|
State income taxes, net of federal benefit
|
(12.85
|
)
|
|
—
|
|
|
—
|
|
Stock-based compensation expense
|
9.76
|
|
|
3.04
|
|
|
4.15
|
|
Change in valuation allowance
|
(7.89
|
)
|
|
32.52
|
|
|
(56.26
|
)
|
Change in federal rates and prior year true ups
|
32.81
|
|
|
(0.64
|
)
|
|
0.70
|
|
Permanent differences
|
0.32
|
|
|
0.08
|
|
|
0.08
|
|
Tax credits
|
—
|
|
|
—
|
|
|
2.66
|
|
Changes in tax reserves
|
(0.15
|
)
|
|
(0.03
|
)
|
|
—
|
|
Impairment of tax attributes due to ownership change
|
—
|
|
|
—
|
|
|
83.67
|
|
Provision (benefit) for income taxes
|
(13.00
|
)%
|
|
(0.03
|
)%
|
|
0.00
|
%
|
|
December 31,
|
||||||
|
2013
|
|
2012
|
||||
Net operating loss carryforwards
|
$
|
138,165
|
|
|
$
|
113,956
|
|
Federal and State credit carryforwards
|
4,263
|
|
|
4,249
|
|
||
Depreciation and amortization
|
8,174
|
|
|
11,866
|
|
||
Capitalized start-up costs
|
1,037
|
|
|
1,185
|
|
||
Accrued liabilities and allowances
|
6,694
|
|
|
35,955
|
|
||
Gross deferred tax assets
|
158,333
|
|
|
167,211
|
|
||
Deferred tax liability
|
—
|
|
|
—
|
|
||
Net deferred tax asset
|
158,333
|
|
|
167,211
|
|
||
Less: Valuation allowance
|
(158,333
|
)
|
|
(159,971
|
)
|
||
Net deferred tax assets
|
$
|
—
|
|
|
$
|
7,240
|
|
|
December 31,
|
||||||||||
|
2013
|
|
2012
|
|
2011
|
||||||
Balance at beginning of year
|
$
|
73,017
|
|
|
$
|
70,613
|
|
|
$
|
13,100
|
|
Additions for current year tax positions
|
—
|
|
|
—
|
|
|
59,419
|
|
|||
Additions for prior year tax positions
|
—
|
|
|
2,437
|
|
|
—
|
|
|||
Reductions for statute of limitations
|
(1,825
|
)
|
|
(27
|
)
|
|
—
|
|
|||
Reductions for prior year tax positions
|
(338
|
)
|
|
(6
|
)
|
|
(1,906
|
)
|
|||
Balance at end of year
|
$
|
70,854
|
|
|
$
|
73,017
|
|
|
$
|
70,613
|
|
|
2013 Quarter Ended
|
||||||||||||||||||||||
|
|
|
March 31,
|
|
|
|
|
|
|
|
|
||||||||||||
Unaudited quarterly financial data
|
As reported
|
|
Revisions (a)
|
|
As Revised (a)
|
|
June 30,
|
|
September 30,
|
|
December 31,
|
||||||||||||
Collaboration revenue
|
$
|
839
|
|
|
$
|
—
|
|
|
$
|
839
|
|
|
$
|
525
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Total revenue
|
844
|
|
|
—
|
|
|
844
|
|
|
525
|
|
|
—
|
|
|
—
|
|
||||||
Research and development
|
9,736
|
|
|
53
|
|
|
9,789
|
|
|
2,235
|
|
|
(166
|
)
|
|
(1
|
)
|
||||||
Selling, general and administrative
|
24,346
|
|
|
318
|
|
|
24,664
|
|
|
528
|
|
|
1,886
|
|
|
451
|
|
||||||
Income (loss) from operations
|
(26,196
|
)
|
|
(371
|
)
|
|
(26,567
|
)
|
|
14,271
|
|
|
(1,692
|
)
|
|
(1,058
|
)
|
||||||
Net income (loss)
|
(26,674
|
)
|
|
(371
|
)
|
|
(27,045
|
)
|
|
15,372
|
|
|
(1,692
|
)
|
|
(1,059
|
)
|
||||||
Basic net income (loss) per common share
|
$
|
(0.71
|
)
|
|
$
|
(0.01
|
)
|
|
$
|
(0.72
|
)
|
|
$
|
0.41
|
|
|
$
|
(0.05
|
)
|
|
$
|
(0.03
|
)
|
Weighted-average number of common shares used in computing basic net income (loss) per common share calculation
|
37,469
|
|
|
—
|
|
|
37,469
|
|
|
37,490
|
|
|
37,490
|
|
|
37,490
|
|
||||||
Diluted net income (loss) per common share
|
$
|
(0.71
|
)
|
|
$
|
(0.01
|
)
|
|
$
|
(0.72
|
)
|
|
$
|
0.41
|
|
|
$
|
(0.05
|
)
|
|
$
|
(0.03
|
)
|
Weighted-average number of common shares used in computing diluted net income (loss) per common share calculation
|
37,469
|
|
|
—
|
|
|
37,469
|
|
|
37,495
|
|
|
37,490
|
|
|
37,490
|
|
||||||
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||
Unaudited balance sheet data
|
|
|
|
|
March 31, 2013
|
|
June 30, 2013
|
|
September 30, 2013
|
|
|
||||||||||||
Additional paid in capital (revised) (Note a)
|
|
|
|
|
$
|
555,947
|
|
|
$
|
554,509
|
|
|
$
|
555,007
|
|
|
|
||||||
Accumulated deficit (revised) (Note a)
|
|
|
|
|
$
|
(570,387
|
)
|
|
$
|
(554,219
|
)
|
|
$
|
(555,911
|
)
|
|
|
|
2012 Quarter Ended
|
||||||||||||||
|
March 31,
|
|
June 30,
|
|
September 30,
|
|
December 31,
|
||||||||
Collaboration revenue
|
$
|
63,205
|
|
|
$
|
2,754
|
|
|
$
|
13,603
|
|
|
$
|
14,796
|
|
Total revenue
|
63,209
|
|
|
2,755
|
|
|
13,607
|
|
|
14,799
|
|
||||
Loss from operations
|
31,520
|
|
|
(31,381
|
)
|
|
(23,990
|
)
|
|
(68,188
|
)
|
||||
Net loss
|
31,453
|
|
|
(31,956
|
)
|
|
(24,638
|
)
|
|
(68,271
|
)
|
||||
Basic net income (loss) per common share
|
$
|
0.88
|
|
|
$
|
(0.89
|
)
|
|
$
|
(0.68
|
)
|
|
$
|
(1.85
|
)
|
Weighted-average number of common shares used in computing basic net income (loss) per common share calculation
|
35,772
|
|
|
36,075
|
|
|
36,350
|
|
|
36,846
|
|
||||
Diluted net income (loss) per common share
|
$
|
0.87
|
|
|
$
|
(0.89
|
)
|
|
$
|
(0.68
|
)
|
|
(1.85
|
)
|
|
Weighted-average number of common shares used in computing diluted net income (loss) per common share calculation
|
36,338
|
|
|
36,075
|
|
|
36,350
|
|
|
36,846
|
|
•
|
Report Independent Registered Public Accounting Firm
|
•
|
Balance Sheets
|
•
|
Statements of Operations
|
•
|
Statements of Comprehensive Loss
|
•
|
Statements of Stockholders' Equity
|
•
|
Statements of Cash Flows
|
•
|
Notes to Financial Statements
|
Exhibit number
|
|
|
|
Description
|
3.3
|
|
|
|
Amended and Restated Certificate of Incorporation(1)
|
3.5
|
|
|
|
Amended and Restated Bylaws(2)
|
4.1
|
|
|
|
Reference is made to exhibits 3.3 and 3.5
|
4.2
|
|
|
|
Specimen Common Stock Certificate(1)
|
4.4
|
|
|
|
Amended and Restated Investor Rights Agreement, dated September 7, 2006, by and between the Registrant and certain of its stockholders(3)
|
4.5
|
|
|
|
Form of Warrant to Oxford Finance Corporation to Purchase shares of Common Stock(4)
|
4.6
|
|
|
|
Form of Warrant to Silicon Valley Bank to Purchase shares of Common Stock(4)
|
4.7
|
|
|
|
Form of Warrant to Purchase shares of Common Stock(5)
|
10.1
|
|
+
|
|
Form of Indemnity Agreement for Directors and Executive Officers(3)
|
10.2
|
|
+
|
|
2001 Stock Option/Stock Issuance Plan(1)
|
10.3
|
|
+
|
|
Form of Notice of Grant of Stock Option, Form of Stock Option Agreement and Form of Stock Purchase Agreement under 2001 Stock Option/Stock Issuance Plan(6)
|
10.4
|
|
+
|
|
Form of Stock Issuance Agreement under 2001 Stock Option/Stock Issuance Agreement(7)
|
10.5
|
|
+
|
|
Amended and Restated 2006 Equity Incentive Plan, as amended March 2, 2011(8)
|
10.6
|
|
+
|
|
Amended and Restated 2006 Equity Incentive Plan, as amended June 13, 2012(9)
|
10.7
|
|
+
|
|
Form of Option Grant Notice and Form of Option Agreement under 2006 Equity Incentive Plan(10)
|
10.8
|
|
+
|
|
2006 Employee Stock Purchase Plan(11)
|
10.9
|
|
+
|
|
Form of Offering Document under 2006 Employee Stock Purchase Plan(12)
|
10.10
|
|
+
|
|
Form of Restricted Stock Unit Notice and Form of Restricted Stock Unit under 2006 Equity Incentive Plan(13)
|
10.11
|
|
+
|
|
Summary of Non-Employee Director Compensation Program(14)
|
10.12
|
|
+
|
|
Reserved
|
10.13
|
|
|
|
Research and Development/Office Lease, dated May 30, 1990, by and between Miranda Associates and Affymax Research Institute(15)
|
10.14
|
|
|
|
First Amendment to Lease, dated November 16, 1999, by and between Spieker Properties, L.P., successor in interest to Miranda Associates, and Affymax Research Institute(16)
|
10.15
|
|
|
|
Second Amendment to Lease, dated December 20, 1999, by and between Spieker Properties, L.P. and Affymax Research Institute(17)
|
10.16
|
|
|
|
Third Amendment, dated December 31, 2001, by and between EOP-Foothill Research Center, L.L.C., successor by merger to Spieker Properties L.P., and the Registrant(18)
|
10.17
|
|
*
|
|
EPO Receptor License Agreement, dated September 5, 1996, by and between the Registrant and Genetics Institute, Inc.(19)
|
10.18
|
|
*
|
|
License Agreement, dated July 27, 2001, by and between the Registrant, Glaxo Group Limited, SmithKline Beecham Corporation, Affymax N.V., Affymax Research Institute and Affymax Technologies N.V.(20)
|
10.19
|
|
*
|
|
License, Manufacturing, and Supply Agreement, dated April 8, 2004, by and between the Registrant and Nektar Therapeutics AL, Corporation(21)
|
10.20
|
|
*
|
|
Collaboration and License Agreement, dated February 13, 2006, by and between the Registrant and Takeda Pharmaceutical Company Limited(22)
|
10.21
|
|
*
|
|
Collaboration and License Agreement, dated June 27, 2006, by and between the Registrant and Takeda Pharmaceutical Company Limited(23)
|
10.22
|
|
|
|
Research and Development Agreement, dated April 2, 1992, by and between the Registrant and The R.W. Johnson Pharmaceutical Research Institute(24)
|
10.23
|
|
|
|
Sublease Agreement, dated September 1, 2006, by and between the Registrant and TIBCO Software Inc.(25)
|
10.24
|
|
|
|
First Amendment to Collaboration and License Agreement, dated April 1, 2007, by and between Registrant and Takeda Pharmaceutical Company Limited(26)
|
10.25
|
|
|
|
Fourth Amendment to Lease, dated November 30, 2006, by and between Registrant and CA-Foothill Research Center L.P.(27)
|
10.26
|
|
|
|
Second Amendment to Collaboration and License Agreements between Registrant and Takeda Pharmaceutical Company Limited effective January 1, 2008(28)
|
10.27
|
|
|
|
Securities Purchase Agreement to purchase shares of Common Stock dated February 13, 2009 by and among Registrant and the purchasers identified on the signature pages thereto(29)
|
10.28
|
|
|
|
Securities Purchase Agreement to purchase shares of Common Stock and Warrants to purchase shares of Common Stock dated February 13, 2009 by and among Registrant and the purchasers identified on the signature pages thereto(30)
|
10.29
|
|
+
|
|
Executive Employment Agreement, as amended January 31, 2013, by and between the Registrant and Anne-Marie Duliege
|
10.30
|
|
+
|
|
Executive Employment Agreement, as amended January 31, 2013, by and between the Registrant and Robert Venteicher
|
10.31
|
|
|
|
Common Stock Purchase Agreement, dated September 25, 2009 by and between the Registrant and Azimuth Opportunity Ltd.(31)
|
10.32
|
|
|
|
Form of Credit Line and related documentation effective as of December 8, 2009 by and between the Registrant and UBS Financial Services, Inc.(32)
|
10.33
|
|
+
|
|
Executive Employment Agreement, dated February 19, 2010, by and between the Registrant and John A. Orwin.(33)
|
10.34
|
|
|
|
Fifth Amendment, dated May 20, 2010, by and between the Registrant and EOP-Foothill Research Center, L.L.C.(34)
|
10.35
|
|
|
|
Amendment No. 1 to Common Stock Purchase Agreement, dated September 17, 2010, between the Registrant and Azimuth Opportunity Ltd.(35)
|
10.36
|
|
+
|
|
Amendment to Employment Agreement between the Registrant and John A. Orwin effective as of September 23, 2010.(36)
|
10.37
|
|
+
|
|
Amendment to Employment Agreement between the Registrant and Anne-Marie Duliege effective as of September 23, 2010.(37)
|
10.38
|
|
+
|
|
Amendment to Employment Agreement between the Registrant and Robert F. Venteicher effective as of September 23, 2010.(38)
|
10.39
|
|
+
|
|
Amended and Restated Executive Employment Agreement, dated February 1, 2011, by and between the Registrant and John A. Orwin.(39)
|
10.40
|
|
+
|
|
Executive Employment Agreement, dated March 4, 2011, by and between the Registrant and Herb Cross.(40)
|
10.41
|
|
|
|
Sixth Amendment to Lease, dated December 21, 2010 by and between Registrant and CA-Foothill Research Center L.P.(41)
|
10.42
|
|
|
|
Amendment No. 2 to Common Stock Purchase Agreement, dated as of May 2, 2011 by and between the Registrant and Azimuth Opportunity Ltd.(42)
|
10.43
|
|
|
|
Settlement and License Agreement, dated as of November 7, 2011, by and between the Registrant and Janssen Biotech, Inc. (43)
|
10.44
|
|
|
|
Third Amendment to Collaboration and License Agreements, effective as of November 7, 2011, by and between the Registrant and Takeda Pharmaceutical Company Limited (44)
|
10.45
|
|
*
|
|
U.S. Co-Promotion Agreement, dated February 24, 2012, by and between the Registrant and Takeda Pharmaceuticals U.S.A., Inc.(45)
|
10.46
|
|
|
|
Loan and Security Agreement, dated March 26, 2012, by and between the Registrant, Oxford Finance Corporation and Silicon Valley Bank(46)
|
10.47
|
|
+
|
|
Executive Employment Agreement, effective as of October 1, 2012, by and between the Registrant and Karin L. Walker(47)
|
10.48
|
|
+
|
|
Executive Employment Agreement, dated January 31, 2013, by and between the Registrant and Jeffrey H. Knapp.
|
23.1
|
|
|
|
Consent of Independent Registered Public Accounting Firm
|
24.1
|
|
|
|
Power of Attorney. Reference is made to the signature page
|
31.1
|
|
|
|
Certification required by Rule 13a-14(a) or Rule 15d-14(a)
|
31.2
|
|
|
|
Certification required by Rule 13a-14(a) or Rule 15d-14(a)
|
32.1
|
|
†
|
|
Certification required by Rule 13a-14(b) or Rule 15d-14(b) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. 1350)
|
101.INS
|
|
#
|
|
XBRL Instance
|
101.SCH
|
|
#
|
|
XBRL Taxonomy Extension Schema
|
101.CAL
|
|
#
|
|
XBRL Taxonomy Extension Calculation
|
101.LAB
|
|
#
|
|
XBRL Taxonomy Extension Labels
|
101.PRE
|
|
#
|
|
XBRL Taxonomy Extension Presentation
|
101.DEF
|
|
#
|
|
XBRL Taxonomy Extension Definition
|
(1)
|
Incorporated by reference to the indicated exhibit in our registration statement on Form S-1/A, registration no. 333-136125, filed with the Securities and Exchange Commission on November 30, 2006.
|
(2)
|
Incorporated by reference to the indicated exhibit in our Form 8-K as filed with the Securities and Exchange Commission on September 10, 2007.
|
(3)
|
Incorporated by reference to the indicated exhibit in our registration statement on Form S-1/A, registration no. 333-136125, filed with the Securities and Exchange Commission on October 2, 2006.
|
(4)
|
Incorporated by reference to the indicated exhibit in our Form 10-Q as filed with the Securities and Exchange Commission on May 9, 2012.
|
(5)
|
Incorporated by reference to Exhibit 4.5 in our Form 8-K as filed with the Securities and Exchange Commission on February 19, 2009.
|
(6)
|
Incorporated by reference to Exhibit 10.3 in our registration statement on Form S-1, registration no. 333-136125, filed with the Securities and Exchange Commission on July 28, 2006.
|
(7)
|
Incorporated by reference to Exhibit 10.4 in our registration statement on Form S-1, registration no. 333-136125, filed with the Securities and Exchange Commission on July 28, 2006.
|
(8)
|
Incorporated by reference to Exhibit 10.5 in our Form 10-Q as filed with the Securities and Exchange Commission on May 9, 2011.
|
(9)
|
Incorporated by reference to Exhibit 10.6 in our Form 10-Q as filed with the Securities and Exchange Commission on August 8, 2012.
|
(10)
|
Incorporated by reference to Exhibit 10.6 in our registration statement on Form S-1, registration no. 333-136125, filed with the Securities and Exchange Commission on July 28, 2006..
|
(11)
|
Incorporated by reference to Exhibit 10.7 in our registration statement on Form S-1, registration no. 333-136125, filed with the Securities and Exchange Commission on July 28, 2006.
|
(12)
|
Incorporated by reference to Exhibit 10.8 in our registration statement on Form S-1/A, registration no. 333-136125, filed with the Securities and Exchange Commission on December 11, 2006.
|
(13)
|
Incorporated by reference to Exhibit 10.9 in our Form 10-K as filed with the Securities and Exchange Commission on March 13, 2008.
|
(14)
|
Incorporated by reference to Exhibit 10.13 in our Form 10-K as filed with the Securities and Exchange Commission on March 12, 2009.
|
(15)
|
Incorporated by reference to Exhibit 10.14 in our registration statement on Form S-1, registration no. 333-136125, filed with the Securities and Exchange Commission on July 28, 2006.
|
(16)
|
Incorporated by reference to Exhibit 10.15 in our registration statement on Form S-1, registration no. 333-136125, filed with the Securities and Exchange Commission on July 28, 2006.
|
(17)
|
Incorporated by reference to Exhibit 10.16 in our registration statement on Form S-1, registration no. 333-136125, filed with the Securities and Exchange Commission on July 28, 2006.
|
(18)
|
Incorporated by reference to Exhibit 10.17 in our registration statement on Form S-1, registration no. 333-136125, filed with the Securities and Exchange Commission on July 28, 2006.
|
(19)
|
Incorporated by reference to Exhibit 10.18 in our registration statement on Form S-1/A, registration no. 333-136125, filed with the Securities and Exchange Commission on December 11, 2006.
|
(20)
|
Incorporated by reference to Exhibit 10.21 in our registration statement on Form S-1, registration no. 333-136125, filed with the Securities and Exchange Commission on July 28, 2006.
|
(21)
|
Incorporated by reference to Exhibit 10.23 in our registration statement on Form S-1/A, registration no. 333-136125, filed with the Securities and Exchange Commission on December 11, 2006.
|
(22)
|
Incorporated by reference to Exhibit 10.24 in our Form 10-Q as filed with the Securities and Exchange Commission on August 5, 2009.
|
(23)
|
Incorporated by reference to Exhibit 10.25 in our Form 10-Q as filed with the Securities and Exchange Commission on August 5, 2009.
|
(24)
|
Incorporated by reference to Exhibit 10.34 in our registration statement on Form S-1, registration no. 333-136125, filed with the Securities and Exchange Commission on July 28, 2006.
|
(25)
|
Incorporated by reference to Exhibit 10.32 in our registration statement on Form S-1/A, registration no. 333-136125, filed with the Securities and Exchange Commission on November 30, 2006.
|
(26)
|
Incorporated by reference to Exhibit 10.28 in our Form 10-Q as filed with the Securities and Exchange Commission on August 5, 2009.
|
(27)
|
Incorporated by reference to Exhibit 10.35 in our Form 10-K as filed with the Securities and Exchange Commission on April 2, 2007.
|
(28)
|
Incorporated by reference to Exhibit 10.30 in our Form 10-K as filed with the Securities and Exchange Commission on March 13, 2008.
|
(29)
|
Incorporated by reference to Exhibit 10.31 in our Form 8-K as filed with the Securities and Exchange Commission on February 19, 2009.
|
(30)
|
Incorporated by reference to Exhibit 10.32 in our Form 8-K as filed with the Securities and Exchange Commission on February 19, 2009.
|
(31)
|
Incorporated by reference to Exhibit 10.35 in our Form 8-K as filed with the Securities and Exchange Commission on September 25, 2009.
|
(32)
|
Incorporated by reference to Exhibit 10.33 in our Form 10-K as filed with the Securities and Exchange Commission on March 4, 2010.
|
(33)
|
Incorporated by reference to Exhibit 10.34 in our Form 10-Q as filed with the Securities and Exchange Commission on May 6, 2010.
|
(34)
|
Incorporated by reference to Exhibit 10.35 in our Form 10-Q as filed with the Securities and Exchange Commission on August 5, 2010.
|
(35)
|
Incorporated by reference to Exhibit 10.36 in our Form 8-K as filed with the Securities and Exchange Commission on September 20, 2010.
|
(36)
|
Incorporated by reference to Exhibit 10.38 in our Form 10-Q as filed with the Securities and Exchange Commission on November 5, 2010.
|
(37)
|
Incorporated by reference to Exhibit10.40 in our Form 10-Q as filed with the Securities and Exchange Commission on November 5, 2010.
|
(38)
|
Incorporated by reference to Exhibit 10.41 in our Form 10-Q as filed with the Securities and Exchange Commission on November 5, 2010.
|
(39)
|
Incorporated by reference to Exhibit 10.41 in our Form 10-Q as filed with the Securities and Exchange Commission on May 9, 2011.
|
(40)
|
Incorporated by reference to Exhibit 10.42 in our Form 10-K as filed with the Securities and Exchange Commission on March 11, 2011.
|
(41)
|
Incorporated by reference to Exhibit 10.43 in our Form 10-K as filed with the Securities and Exchange Commission on March 11, 2011.
|
(42)
|
Incorporated by reference to Exhibit 10.45 in our Form 10-Q as filed with the Securities and Exchange Commission on August 8, 2011
|
(43)
|
Incorporated by reference to Exhibit 10.47 in our Form 10-K as filed with the Securities and Exchange Commission on March 14, 2012.
|
(44)
|
Incorporated by reference to Exhibit 10.48 in our Form 10-K as filed with the Securities and Exchange Commission on March 14, 2012.
|
(45)
|
Incorporated by reference to Exhibit 10.49 in our Form 10-Q/A as filed with the Securities and Exchange Commission on July 2, 2012.
|
(46)
|
Incorporated by reference to Exhibit 10.50 in our Form 10-Q as filed with the Securities and Exchange Commission on May 9, 2012.
|
(47)
|
Incorporated by reference to Exhibit 10.51 in our Form 10-Q as filed with the Securities and Exchange Commission on November 9, 2012.
|
(48)
|
Incorporated by reference to Exhibit 10.52 in our Form 10-K as filed with the Securities and Exchange Commission on April 2, 2013.
|
(49)
|
Incorporated by reference to Exhibit 10.53 in our Form 10-Q/A as filed with the Securities and Exchange Commission on May 9, 2013
|
(50)
|
Incorporated by reference to Exhibit 10.54 in our Form 10-Q as filed with the Securities and Exchange Commission on August 5, 2013
|
(51)
|
Incorporated by reference to Exhibit 10.55 in our Form 10-Q as filed with the Securities and Exchange Commission on November 5, 2013
|
|
|
|
|
|
|
|
AFFYMAX, INC.
|
||
|
|
By:
|
|
/s/ RICHARD M. BRENNER
|
|
|
|
|
Richard M. Brenner
Chief Executive Officer and
Member of the Board of Directors
|
|
|
|
|
|
Signature
|
|
Title
|
|
Date
|
|
|
|
|
|
/s/ RICHARD M. BRENNER
|
|
Chief Executive Officer and
|
|
|
Richard M. Brenner
|
|
Member of the Board of Directors
(Principal Executive Officer)
|
|
March 31, 2014
|
/s/ MARK G. THOMPSON
|
|
Chief Financial Officer
|
|
|
Mark G. Thompson
|
|
(Principal Financial Officer)
|
|
March 31, 2014
|
/s/ HOLLINGS C. RENTON
|
|
Member of the Board of Directors
|
|
March 31, 2014
|
Hollings C. Renton
|
|
|
|
|
/s/ JOHN A. ORWIN
|
|
Member of the Board of Directors
|
|
March 31, 2014
|
John A. Orwin
|
|
|
|
|
/s/ CHRISTI VAN HEEK
|
|
Member of the Board of Directors
|
|
March 31, 2014
|
Christi van Heek
|
|
|
|
|
/s/ JOHN P. WALKER
|
|
Member of the Board of Directors
|
|
March 31, 2014
|
John P. Walker
|
|
|
|
|
Exhibit number
|
|
|
|
Description
|
3.3
|
|
|
|
Amended and Restated Certificate of Incorporation(1)
|
3.5
|
|
|
|
Amended and Restated Bylaws(2)
|
4.1
|
|
|
|
Reference is made to exhibits 3.3 and 3.5
|
4.2
|
|
|
|
Specimen Common Stock Certificate(1)
|
4.4
|
|
|
|
Amended and Restated Investor Rights Agreement, dated September 7, 2006, by and between the Registrant and certain of its stockholders(3)
|
4.5
|
|
|
|
Form of Warrant to Oxford Finance Corporation to Purchase shares of Common Stock(4)
|
4.6
|
|
|
|
Form of Warrant to Silicon Valley Bank to Purchase shares of Common Stock(4)
|
4.7
|
|
|
|
Form of Warrant to Purchase shares of Common Stock(5)
|
10.1
|
|
+
|
|
Form of Indemnity Agreement for Directors and Executive Officers(3)
|
10.2
|
|
+
|
|
2001 Stock Option/Stock Issuance Plan(1)
|
10.3
|
|
+
|
|
Form of Notice of Grant of Stock Option, Form of Stock Option Agreement and Form of Stock Purchase Agreement under 2001 Stock Option/Stock Issuance Plan(6)
|
10.4
|
|
+
|
|
Form of Stock Issuance Agreement under 2001 Stock Option/Stock Issuance Agreement(7)
|
10.5
|
|
+
|
|
Amended and Restated 2006 Equity Incentive Plan, as amended March 2, 2011(8)
|
10.6
|
|
+
|
|
Amended and Restated 2006 Equity Incentive Plan, as amended June 13, 2012(9)
|
10.7
|
|
+
|
|
Form of Option Grant Notice and Form of Option Agreement under 2006 Equity Incentive Plan(10)
|
10.8
|
|
+
|
|
2006 Employee Stock Purchase Plan(11)
|
10.9
|
|
+
|
|
Form of Offering Document under 2006 Employee Stock Purchase Plan(12)
|
10.10
|
|
+
|
|
Form of Restricted Stock Unit Notice and Form of Restricted Stock Unit under 2006 Equity Incentive Plan(13)
|
10.11
|
|
+
|
|
Summary of Non-Employee Director Compensation Program(14)
|
10.12
|
|
+
|
|
Reserved
|
10.13
|
|
|
|
Research and Development/Office Lease, dated May 30, 1990, by and between Miranda Associates and Affymax Research Institute(15)
|
10.14
|
|
|
|
First Amendment to Lease, dated November 16, 1999, by and between Spieker Properties, L.P., successor in interest to Miranda Associates, and Affymax Research Institute(16)
|
10.15
|
|
|
|
Second Amendment to Lease, dated December 20, 1999, by and between Spieker Properties, L.P. and Affymax Research Institute(17)
|
10.16
|
|
|
|
Third Amendment, dated December 31, 2001, by and between EOP-Foothill Research Center, L.L.C., successor by merger to Spieker Properties L.P., and the Registrant(18)
|
10.17
|
|
*
|
|
EPO Receptor License Agreement, dated September 5, 1996, by and between the Registrant and Genetics Institute, Inc.(19)
|
10.18
|
|
*
|
|
License Agreement, dated July 27, 2001, by and between the Registrant, Glaxo Group Limited, SmithKline Beecham Corporation, Affymax N.V., Affymax Research Institute and Affymax Technologies N.V.(20)
|
10.19
|
|
*
|
|
License, Manufacturing, and Supply Agreement, dated April 8, 2004, by and between the Registrant and Nektar Therapeutics AL, Corporation(21)
|
10.20
|
|
*
|
|
Collaboration and License Agreement, dated February 13, 2006, by and between the Registrant and Takeda Pharmaceutical Company Limited(22)
|
10.21
|
|
*
|
|
Collaboration and License Agreement, dated June 27, 2006, by and between the Registrant and Takeda Pharmaceutical Company Limited(23)
|
10.22
|
|
|
|
Research and Development Agreement, dated April 2, 1992, by and between the Registrant and The R.W. Johnson Pharmaceutical Research Institute(24)
|
10.23
|
|
|
|
Sublease Agreement, dated September 1, 2006, by and between the Registrant and TIBCO Software Inc.(25)
|
10.24
|
|
|
|
First Amendment to Collaboration and License Agreement, dated April 1, 2007, by and between Registrant and Takeda Pharmaceutical Company Limited(26)
|
10.25
|
|
|
|
Fourth Amendment to Lease, dated November 30, 2006, by and between Registrant and CA-Foothill Research Center L.P.(27)
|
10.26
|
|
|
|
Second Amendment to Collaboration and License Agreements between Registrant and Takeda Pharmaceutical Company Limited effective January 1, 2008(28)
|
10.27
|
|
|
|
Securities Purchase Agreement to purchase shares of Common Stock dated February 13, 2009 by and among Registrant and the purchasers identified on the signature pages thereto(29)
|
10.28
|
|
|
|
Securities Purchase Agreement to purchase shares of Common Stock and Warrants to purchase shares of Common Stock dated February 13, 2009 by and among Registrant and the purchasers identified on the signature pages thereto(30)
|
10.29
|
|
+
|
|
Executive Employment Agreement, as amended January 31, 2013, by and between the Registrant and Anne-Marie Duliege
|
10.30
|
|
+
|
|
Executive Employment Agreement, as amended January 31, 2013, by and between the Registrant and Robert Venteicher
|
10.31
|
|
|
|
Common Stock Purchase Agreement, dated September 25, 2009 by and between the Registrant and Azimuth Opportunity Ltd.(31)
|
10.32
|
|
|
|
Form of Credit Line and related documentation effective as of December 8, 2009 by and between the Registrant and UBS Financial Services, Inc.(32)
|
10.33
|
|
+
|
|
Executive Employment Agreement, dated February 19, 2010, by and between the Registrant and John A. Orwin.(33)
|
10.34
|
|
|
|
Fifth Amendment, dated May 20, 2010, by and between the Registrant and EOP-Foothill Research Center, L.L.C.(34)
|
10.35
|
|
|
|
Amendment No. 1 to Common Stock Purchase Agreement, dated September 17, 2010, between the Registrant and Azimuth Opportunity Ltd.(35)
|
10.36
|
|
+
|
|
Amendment to Employment Agreement between the Registrant and John A. Orwin effective as of September 23, 2010.(36)
|
10.37
|
|
+
|
|
Amendment to Employment Agreement between the Registrant and Anne-Marie Duliege effective as of September 23, 2010.(37)
|
10.38
|
|
+
|
|
Amendment to Employment Agreement between the Registrant and Robert F. Venteicher effective as of September 23, 2010.(38)
|
10.39
|
|
+
|
|
Amended and Restated Executive Employment Agreement, dated February 1, 2011, by and between the Registrant and John A. Orwin.(39)
|
10.40
|
|
+
|
|
Executive Employment Agreement, dated March 4, 2011, by and between the Registrant and Herb Cross.(40)
|
10.41
|
|
|
|
Sixth Amendment to Lease, dated December 21, 2010 by and between Registrant and CA-Foothill Research Center L.P.(41)
|
10.42
|
|
|
|
Amendment No. 2 to Common Stock Purchase Agreement, dated as of May 2, 2011 by and between the Registrant and Azimuth Opportunity Ltd.(42)
|
10.43
|
|
|
|
Settlement and License Agreement, dated as of November 7, 2011, by and between the Registrant and Janssen Biotech, Inc. (43)
|
10.44
|
|
|
|
Third Amendment to Collaboration and License Agreements, effective as of November 7, 2011, by and between the Registrant and Takeda Pharmaceutical Company Limited (44)
|
10.45
|
|
*
|
|
U.S. Co-Promotion Agreement, dated February 24, 2012, by and between the Registrant and Takeda Pharmaceuticals U.S.A., Inc.(45)
|
10.46
|
|
|
|
Loan and Security Agreement, dated March 26, 2012, by and between the Registrant, Oxford Finance Corporation and Silicon Valley Bank(46)
|
10.47+
|
|
|
|
Executive Employment Agreement, effective as of October 1, 2012, by and between the Registrant and Karin L. Walker(47)
|
10.48+
|
|
|
|
Executive Employment Agreement, dated January 31, 2013, by and between the Registrant and Jeffrey H. Knapp.
|
10.49
|
|
|
|
Consulting Engagement Agreement, date April 19, 2013 between Registrant and The Brenner Group
|
23.1
|
|
|
|
Consent of Independent Registered Public Accounting Firm
|
24.1
|
|
|
|
Power of Attorney. Reference is made to the signature page
|
31.1
|
|
|
|
Certification required by Rule 13a-14(a) or Rule 15d-14(a)
|
31.2
|
|
|
|
Certification required by Rule 13a-14(a) or Rule 15d-14(a)
|
32.1
|
|
†
|
|
Certification required by Rule 13a-14(b) or Rule 15d-14(b) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. 1350)
|
101.INS
|
|
#
|
|
XBRL Instance
|
101.SCH
|
|
#
|
|
XBRL Taxonomy Extension Schema
|
101.CAL
|
|
#
|
|
XBRL Taxonomy Extension Calculation
|
101.LAB
|
|
#
|
|
XBRL Taxonomy Extension Labels
|
101.PRE
|
|
#
|
|
XBRL Taxonomy Extension Presentation
|
101.DEF
|
|
#
|
|
XBRL Taxonomy Extension Definition
|
(1)
|
Incorporated by reference to the indicated exhibit in our registration statement on Form S-1/A, registration no. 333-136125, filed with the Securities and Exchange Commission on November 30, 2006.
|
(2)
|
Incorporated by reference to the indicated exhibit in our Form 8-K as filed with the Securities and Exchange Commission on September 10, 2007.
|
(3)
|
Incorporated by reference to the indicated exhibit in our registration statement on Form S-1/A, registration no. 333-136125, filed with the Securities and Exchange Commission on October 2, 2006.
|
(4)
|
Incorporated by reference to the indicated exhibit in our Form 10-Q as filed with the Securities and Exchange Commission on May 9, 2012.
|
(5)
|
Incorporated by reference to Exhibit 4.5 in our Form 8-K as filed with the Securities and Exchange Commission on February 19, 2009.
|
(6)
|
Incorporated by reference to Exhibit 10.3 in our registration statement on Form S-1, registration no. 333-136125, filed with the Securities and Exchange Commission on July 28, 2006.
|
(7)
|
Incorporated by reference to Exhibit 10.4 in our registration statement on Form S-1, registration no. 333-136125, filed with the Securities and Exchange Commission on July 28, 2006.
|
(8)
|
Incorporated by reference to Exhibit 10.5 in our Form 10-Q as filed with the Securities and Exchange Commission on May 9, 2011.
|
(9)
|
Incorporated by reference to Exhibit 10.6 in our Form 10-Q as filed with the Securities and Exchange Commission on August 8, 2012.
|
(10)
|
Incorporated by reference to Exhibit 10.6 in our registration statement on Form S-1, registration no. 333-136125, filed with the Securities and Exchange Commission on July 28, 2006..
|
(11)
|
Incorporated by reference to Exhibit 10.7 in our registration statement on Form S-1, registration no. 333-136125, filed with the Securities and Exchange Commission on July 28, 2006.
|
(12)
|
Incorporated by reference to Exhibit 10.8 in our registration statement on Form S-1/A, registration no. 333-136125, filed with the Securities and Exchange Commission on December 11, 2006.
|
(13)
|
Incorporated by reference to Exhibit 10.9 in our Form 10-K as filed with the Securities and Exchange Commission on March 13, 2008.
|
(14)
|
Incorporated by reference to Exhibit 10.13 in our Form 10-K as filed with the Securities and Exchange Commission on March 12, 2009.
|
(15)
|
Incorporated by reference to Exhibit 10.14 in our registration statement on Form S-1, registration no. 333-136125, filed with the Securities and Exchange Commission on July 28, 2006.
|
(16)
|
Incorporated by reference to Exhibit 10.15 in our registration statement on Form S-1, registration no. 333-136125, filed with the Securities and Exchange Commission on July 28, 2006.
|
(17)
|
Incorporated by reference to Exhibit 10.16 in our registration statement on Form S-1, registration no. 333-136125, filed with the Securities and Exchange Commission on July 28, 2006.
|
(18)
|
Incorporated by reference to Exhibit 10.17 in our registration statement on Form S-1, registration no. 333-136125, filed with the Securities and Exchange Commission on July 28, 2006.
|
(19)
|
Incorporated by reference to Exhibit 10.18 in our registration statement on Form S-1/A, registration no. 333-136125, filed with the Securities and Exchange Commission on December 11, 2006.
|
(20)
|
Incorporated by reference to Exhibit 10.21 in our registration statement on Form S-1, registration no. 333-136125, filed with the Securities and Exchange Commission on July 28, 2006.
|
(21)
|
Incorporated by reference to Exhibit 10.23 in our registration statement on Form S-1/A, registration no. 333-136125, filed with the Securities and Exchange Commission on December 11, 2006.
|
(22)
|
Incorporated by reference to Exhibit 10.24 in our Form 10-Q as filed with the Securities and Exchange Commission on August 5, 2009.
|
(23)
|
Incorporated by reference to Exhibit 10.25 in our Form 10-Q as filed with the Securities and Exchange Commission on August 5, 2009.
|
(24)
|
Incorporated by reference to Exhibit 10.34 in our registration statement on Form S-1, registration no. 333-136125, filed with the Securities and Exchange Commission on July 28, 2006.
|
(25)
|
Incorporated by reference to Exhibit 10.32 in our registration statement on Form S-1/A, registration no. 333-136125, filed with the Securities and Exchange Commission on November 30, 2006.
|
(26)
|
Incorporated by reference to Exhibit 10.28 in our Form 10-Q as filed with the Securities and Exchange Commission on August 5, 2009.
|
(27)
|
Incorporated by reference to Exhibit 10.35 in our Form 10-K as filed with the Securities and Exchange Commission on April 2, 2007.
|
(28)
|
Incorporated by reference to Exhibit 10.30 in our Form 10-K as filed with the Securities and Exchange Commission on March 13, 2008.
|
(29)
|
Incorporated by reference to Exhibit 10.31 in our Form 8-K as filed with the Securities and Exchange Commission on February 19, 2009.
|
(30)
|
Incorporated by reference to Exhibit 10.32 in our Form 8-K as filed with the Securities and Exchange Commission on February 19, 2009.
|
(31)
|
Incorporated by reference to Exhibit 10.35 in our Form 8-K as filed with the Securities and Exchange Commission on September 25, 2009.
|
(32)
|
Incorporated by reference to Exhibit 10.33 in our Form 10-K as filed with the Securities and Exchange Commission on March 4, 2010.
|
(33)
|
Incorporated by reference to Exhibit 10.34 in our Form 10-Q as filed with the Securities and Exchange Commission on May 6, 2010.
|
(34)
|
Incorporated by reference to Exhibit 10.35 in our Form 10-Q as filed with the Securities and Exchange Commission on August 5, 2010.
|
(35)
|
Incorporated by reference to Exhibit 10.36 in our Form 8-K as filed with the Securities and Exchange Commission on September 20, 2010.
|
(36)
|
Incorporated by reference to Exhibit 10.38 in our Form 10-Q as filed with the Securities and Exchange Commission on November 5, 2010.
|
(37)
|
Incorporated by reference to Exhibit10.40 in our Form 10-Q as filed with the Securities and Exchange Commission on November 5, 2010.
|
(38)
|
Incorporated by reference to Exhibit 10.41 in our Form 10-Q as filed with the Securities and Exchange Commission on November 5, 2010.
|
(39)
|
Incorporated by reference to Exhibit 10.41 in our Form 10-Q as filed with the Securities and Exchange Commission on May 9, 2011.
|
(40)
|
Incorporated by reference to Exhibit 10.42 in our Form 10-K as filed with the Securities and Exchange Commission on March 11, 2011.
|
(41)
|
Incorporated by reference to Exhibit 10.43 in our Form 10-K as filed with the Securities and Exchange Commission on March 11, 2011.
|
(42)
|
Incorporated by reference to Exhibit 10.45 in our Form 10-Q as filed with the Securities and Exchange Commission on August 8, 2011
|
(43)
|
Incorporated by reference to Exhibit 10.47 in our Form 10-K as filed with the Securities and Exchange Commission on March 14, 2012.
|
(44)
|
Incorporated by reference to Exhibit 10.48 in our Form 10-K as filed with the Securities and Exchange Commission on March 14, 2012.
|
(45)
|
Incorporated by reference to Exhibit 10.49 in our Form 10-Q/A as filed with the Securities and Exchange Commission on July 2, 2012.
|
(46)
|
Incorporated by reference to Exhibit 10.50 in our Form 10-Q as filed with the Securities and Exchange Commission on May 9, 2012.
|
(47)
|
Incorporated by reference to Exhibit 10.51 in our Form 10-Q as filed with the Securities and Exchange Commission on November 9, 2012.
|
2.
|
COMPENSATION.
|
3.
|
PROPRIETARY INFORMATION OBLIGATIONS.
|
4.
|
OUTSIDE ACTIVITIES DURING EMPLOYMENT.
|
5.
|
TERMINATION OF EMPLOYMENT.
|
2.
|
COMPENSATION.
|
3.
|
PROPRIETARY INFORMATION OBLIGATIONS.
|
4.
|
OUTSIDE ACTIVITIES DURING EMPLOYMENT.
|
5.
|
TERMINATION OF EMPLOYMENT.
|
2.
|
COMPENSATION.
|
3.
|
PROPRIETARY INFORMATION OBLIGATIONS.
|
4.
|
OUTSIDE ACTIVITIES DURING EMPLOYMENT.
|
5.
|
TERMINATION OF EMPLOYMENT.
|
A.
|
Consultant is in the business of providing management services to client companies in all areas of business operations.
|
C.
|
Consultant and Client desire to enter into a consulting arrangement upon the terms and conditions set forth herein.
|
1.
|
ENGAGEMENT:
Client agrees to engage Consultant under the terms of this Agreement, and Consultant agrees to accept such engagement. Consultant, or its representative shall be available to Client according to the time or the projects specified in Exhibit A, attached hereto and made a part of this Agreement by reference herein.
|
2.
|
TERM AND TERMINATION:
Consultant's engagement pursuant to this Agreement shall commence on April 19, 2013 and continue until April 30, 2014, unless terminated earlier, as provided herein (the "Term"). At the end of the Term, this Agreement shall automatically be extended for periods of three months each, unless one party gives the other party 30 days’ notice of their intent to not extend the Agreement. Other than for the reasons described in Section 4, below, either party may terminate this Agreement during the Term, or any extensions thereof, by giving the other party two months written notice of termination.
|
3.
|
COMPENSATION:
As compensation for services rendered by Consultant pursuant to this Agreement, Client shall pay Consultant the sum(s) as shown on Exhibit A, plus reimbursement for any expenses incurred on Client's behalf. If Consultant uses an automobile on Client's behalf, Client shall reimburse Consultant for actual miles traveled at the rate of $0.58 per mile. For on-site engagements of less than four (4) hours, Consultant shall invoice Client for travel time to and from Client’s premises (or other designated meeting site as defined by Client). Client and Consultant agree that Exhibit A may
|
5.
|
INVOICING AND PAYMENT:
Consultant shall provide an invoice reasonably detailed to Client as of the fifteenth and last day of each month for services performed pursuant to this Agreement. Consultant shall apply the invoice against the Retainer.
|
6.
|
RETAINER:
Upon execution of this Agreement, Clients agrees to pay Consultant a retainer (“Retainer”) of $50,000, and to replenish Retainer whenever the Retainer balance is $15,000 or less. Any amounts remaining at the termination of the Assignment will be refunded to Client.
|
8.
|
NON DISCLOSURE:
Client and Consultant acknowledge that they have entered into a non-disclosure agreement which was effective as of April 2, 2013, and that such non-disclosure agreement is incorporated herein by reference.
|
9.
|
INDEMNITY:
Client shall have its insurance in effect during the term of this Agreement, including its Directors and Officers Liability insurance, and add The Brenner Group, Inc., Richard M. Brenner, J. Weston Rose, and Mark Thompson as named insureds under the policy. Client will furnish Consultant a certificate of insurance indicating the coverage above within two business days after the Commencement Date of this Agreement.
|
A.
|
ASSIGNMENT:
This Agreement may not be assigned by either party hereto without the prior written consent of the other.
|
B.
|
ADDITIONAL PERSONNEL:
Consultant may use additional personnel to support the requirements of Client under this Agreement. The additional personnel will only be used after Client has agreed in writing to: (a) such addition; (b) the compensation for such addition; (c) the term of such addition, and (d) such addition is made a part of this Agreement by an amendment to Exhibit A and executed by both parties.
|
E.
|
AMENDMENT; ENTIRE AGREEMENT: This Agreement may be amended only in writing, and signed by both parties. This Agreement sets forth the entire understanding of the parties with respect to the subject matter hereof, and expressly terminates and supersedes any and all
|
G.
|
PARTIAL INVALIDITY: If any provision of this Agreement is found to be invalid by any court or other authority, the invalidity of such provision shall not affect the validity of the
|
|
|
By:
|
/s/ RICHARD M. BRENNER
|
|
|
|
Chief Executive Officer and Member of the Board of Directors
|
Date:
|
March 31, 2014
|
|
(Principal Executive Officer)
|
|
|
By:
|
/s/ MARK G. THOMPSON
|
|
|
|
Chief Financial Officer
|
Date:
|
March 31, 2014
|
|
(Principal Financial Officer)
|
|
|
By:
|
/s/ RICHARD M. BRENNER
|
|
|
|
Chief Executive Officer and Director
(Principal Executive Officer)
|
|
|
By:
|
/s/ MARK G. THOMPSON
|
|
|
|
Chief Financial Officer
|
Date:
|
March 31, 2014
|
|
(Principal Financial Officer)
|