(Mark One) | ||
þ
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934 |
|
For the quarterly period ended June 30, 2009 | ||
OR
|
||
o
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |
For the transition period from to |
Delaware | 03-0491827 | |
(State or other jurisdiction
of
incorporation or organization) |
(I.R.S. Employer
Identification No.) |
|
9605 Medical Center Drive, Suite 300
Rockville, Maryland (Address of principal executive offices) |
20850
(Zip Code) |
Large accelerated filer o | Accelerated filer þ | Non-accelerated filer o | Smaller reporting company o |
2
Item 1.
Financial
Statements (Unaudited).
(A Development Stage Enterprise)
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
3
(A Development Stage Enterprise)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Period from
March 13,
2003
Three Months Ended
Six Months Ended
(Inception) to
June 30,
June 30,
June 30,
June 30,
June 30,
2009
2008
2009
2008
2009
$
$
$
$
$
81,545
229,352
229,352
229,352
7,195,595
5,480,909
9,528,934
16,583,574
159,114,253
4,988,317
8,454,985
9,212,351
17,414,199
95,131,191
12,413,264
13,935,894
18,970,637
33,997,773
254,474,796
(12,413,264
)
(13,935,894
)
(18,970,637
)
(33,997,773
)
(254,393,251
)
21,163
441,012
74,549
1,306,762
10,554,220
(80,485
)
71,947
21,163
441,012
74,549
1,306,762
10,545,682
(12,392,101
)
(13,494,882
)
(18,896,088
)
(32,691,011
)
(243,847,569
)
23,026
(12,392,101
)
(13,494,882
)
(18,896,088
)
(32,691,011
)
(243,870,595
)
(33,486,623
)
$
(12,392,101
)
$
(13,494,882
)
$
(18,896,088
)
$
(32,691,011
)
$
(277,357,218
)
$
(0.46
)
$
(0.51
)
$
(0.71
)
$
(1.23
)
26,900,841
26,649,439
26,777,159
26,648,892
4
(A Development Stage Enterprise)
CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN
STOCKHOLDERS EQUITY (Unaudited)
Accumulated
Deficit
Additional
Other
Accumulated
Common Stock
Paid-In
Comprehensive
During the
Comprehensive
Shares
Par Value
Capital
Income (Loss)
Development Stage
Loss
Total
26,653,478
$
26,653
$
270,988,157
$
(20,029
)
$
(224,974,507
)
$
46,020,274
486,658
487
882,356
882,843
5,057,177
5,057,177
222,189
222,189
(18,896,088
)
$
(18,896,088
)
20,242
20,242
$
(18,875,846
)
(18,875,846
)
27,140,136
$
27,140
$
277,149,879
$
213
$
(243,870,595
)
$
33,306,637
5
(A Development Stage Enterprise)
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
Period from
March 13,
2003
Six Months Ended
(Inception) to
June 30,
June 30,
June 30,
2009
2008
2009
$
(18,896,088
)
$
(32,691,011
)
$
(243,870,595
)
239,669
259,707
2,739,331
5,279,366
9,074,594
49,602,678
211
57,458
96,599
(195,911
)
(2,130,721
)
229,352
229,352
158,206
(247,729
)
(1,129,194
)
(1,272,240
)
(1,272,240
)
1,404,519
2,425,921
1,916,901
1,516,814
(5,979,353
)
4,415,231
2,041
136,734
504,811
(11,241,762
)
(27,216,837
)
(188,936,988
)
(7,000,000
)
(7,000,000
)
(479,581
)
(4,381,391
)
200,179
(8,082,729
)
(2,081,121
)
(275,901,472
)
126,547
4,875,076
97,100,390
10,250,000
39,460,000
175,925,000
(430,230
)
(4,706,182
)
41,774,374
(14,487,524
)
515,147
(91,797
)
(515,147
)
61,795,187
882,843
1,190,352
164,588,801
882,843
227,482,543
16,745
(43,828
)
(15,065,101
)
14,574,282
24,014,203
39,079,304
41,929,533
$
24,014,203
$
56,503,815
$
24,014,203
$
5,000,000
$
5,000,000
6
(A Development Stage Enterprise)
1.
Business
Organization and Presentation
7
(A Development Stage Enterprise)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED) (Continued)
2.
Summary
of Significant Accounting Policies
8
(A Development Stage Enterprise)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED) (Continued)
9
(A Development Stage Enterprise)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED) (Continued)
Period from
Three Months Ended
Six Months Ended
March 13, 2003
June 30,
June 30,
June 30,
June 30,
(Inception) to
2009
2008
2009
2008
June 30, 2009
$
582,558
$
696,937
$
809,678
$
1,852,330
$
8,349,867
2,171,824
3,270,503
4,247,499
7,233,648
40,882,837
$
2,754,382
$
3,967,440
$
5,057,177
$
9,085,978
$
49,232,704
$
0.10
$
0.15
$
0.19
$
0.34
26,900,841
26,649,439
26,777,159
26,648,892
10
(A Development Stage Enterprise)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED) (Continued)
Six Months Ended
June 30,
June 30,
2009
2008
0
%
0
%
68
%
68
%
6.03
6.05
2.96
%
3.28
%
Weighted
Weighted
Average
Average
Number of
Exercise Price
Remaining Term
Aggregate
Shares
at Grant Date
(Years)
Intrinsic Value
1,154,248
$
1.74
(93,184
)
3.48
(26,793
)
2.71
1,034,271
1.53
6.20
$
10,588,389
960,592
1.46
6.18
$
9,926,801
Weighted
Weighted
Average
Average
Number of
Exercise Price
Remaining Term
Aggregate
Shares
at Grant Date
(Years)
Intrinsic Value
2,631,381
$
17.43
875,000
12.57
(102,445
)
6.53
(82,786
)
16.43
(299,901
)
13.70
3,021,249
17.31
8.54
$
5,872,450
1,226,109
21.88
7.87
$
2,020,732
11
(A Development Stage Enterprise)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED) (Continued)
Weighted
Number of
Average
Aggregate
Shares
Price/Share
Intrinsic Value
623,000
0.57
$
311,500
45,000
3.88
(309,000
)
0.57
(35,000
)
0.57
324,000
1.02
$
3,813,480
12
(A Development Stage Enterprise)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED) (Continued)
13
(A Development Stage Enterprise)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED) (Continued)
3.
Earnings
per Share
Three Months Ended
Six Months Ended
June 30,
June 30,
June 30,
June 30,
2009
2008
2009
2008
$
(12,392,101
)
$
(13,494,882
)
$
(18,896,088
)
$
(32,691,011
)
26,900,841
26,652,728
26,777,159
26,652,728
(3,289
)
(3,836
)
26,900,841
26,649,439
26,777,159
26,648,892
$
(0.46
)
$
(0.51
)
$
(0.71
)
$
(1.23
)
4,379,520
3,998,499
4,379,520
3,998,499
14
(A Development Stage Enterprise)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED) (Continued)
4.
Marketable
Securities
Gross
Gross
Amortized
Unrealized
Unrealized
Fair Market
Cost
Gains
Losses
Value
$
4,008,716
$
181
$
(34
)
$
4,008,863
999,694
66
999,760
$
5,008,410
$
247
$
(34
)
$
5,008,623
Gross
Gross
Amortized
Unrealized
Unrealized
Fair Market
Cost
Gains
Losses
Value
$
1,992,452
$
7,408
$
$
1,999,860
5,279,828
2,336
(29,818
)
5,252,346
126,547
45
126,592
$
7,398,827
$
9,789
$
(29,818
)
$
7,378,798
5.
Prepaid
Expenses, Deposits and Other Current Assets
June 30,
December 31,
2009
2008
$
210,000
$
210,000
615,340
282,391
49,343
53,378
254,511
326,201
415,430
$
1,129,194
$
1,287,400
6.
Inventory
June 30,
2009
$
1,272,240
$
1,272,240
15
(A Development Stage Enterprise)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED) (Continued)
7.
Property
and Equipment
Estimated Useful Life
June 30,
December 31,
(Years)
2009
2008
5
$
1,348,098
$
1,348,098
3
776,921
776,921
7
705,784
705,784
10
844,158
844,158
3,674,961
3,674,961
(2,156,519
)
(1,916,850
)
$
1,518,442
$
1,758,111
8.
Intangible
Asset, Net
June 30, 2009
Gross
Net
Carrying
Accumulated
Carrying
Estimated Useful Lives
Amount
Amortization
Amount
8 years
$
12,000,000
$
229,352
$
11,770,648
$
12,000,000
$
229,352
$
11,770,648
16
(A Development Stage Enterprise)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED) (Continued)
9.
Accrued
Liabilities
June 30,
December 31,
2009
2008
$
3,337,632
$
925,124
436,534
233,829
170,169
126,816
470,896
1,612,648
$
4,415,231
$
2,898,417
10.
Commitments
and Contingencies
Six Months Ended June 30, 2009
Beginning
Ending
Balance
Charge
Cash Paid
Balance
$
571,391
$
$
402,828
$
168,563
1,041,257
738,924
302,333
$
1,612,648
$
$
1,141,752
$
470,896
17
(A Development Stage Enterprise)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED) (Continued)
18
(A Development Stage Enterprise)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED) (Continued)
11.
Income
Taxes
19
(A Development Stage Enterprise)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED) (Continued)
12.
Fair
Value Measurements
Level 1 defined as observable inputs such as
quoted prices in active markets
Level 2 defined as inputs other than quoted
prices in active markets that are either directly or indirectly
observable
Level 3 defined as unobservable inputs in which
little or no market data exists, therefore requiring an entity
to develop its own assumptions
Fair Value Measurements at Reporting Date Using
Quoted Prices in
Active Markets for
Significant Other
Significant
June 30,
Identical Assets
Observable Inputs
Unobservable Inputs
2009
(Level 1)
(Level 2)
(Level 3)
$
5,008,623
$
4,008,863
$
999,760
$
$
5,008,623
$
4,008,863
$
999,760
$
20
(A Development Stage Enterprise)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED) (Continued)
Fair Value Measurements at Reporting Date Using
Quoted Prices in
Active Markets for
Significant Other
Significant
December 31,
Identical Assets
Observable Inputs
Unobservable Inputs
2008
(Level 1)
(Level 2)
(Level 3)
$
7,378,798
$
1,999,860
$
5,378,938
$
$
7,378,798
$
1,999,860
$
5,378,938
$
13.
Subsequent
Events
21
Item 2.
Managements
Discussion and Analysis of Financial Condition and Results of
Operations.
delays in the completion of our clinical trials;
a failure of our products to be demonstrably safe and effective;
our failure to obtain regulatory approval for our products or to
comply with ongoing regulatory requirements for our products;
a lack of acceptance of our products in the marketplace, or a
failure to become or remain profitable;
our expectations regarding trends with respect to our costs and
expenses;
our inability to obtain the capital necessary to fund our
commercial, research and development activities;
our failure to identify or obtain rights to new products;
our failure to develop or obtain sales, marketing and
distribution resources and expertise or to otherwise manage our
growth;
a loss of any of our key scientists or management personnel;
losses incurred from product liability claims made against
us; and
a loss of rights to develop and commercialize our products under
our license and sublicense agreements.
Fanapt
tm
(iloperidone), a compound for the treatment of schizophrenia. On
November 27, 2007, the FDA accepted a New Drug Application
(NDA) for
Fanapt
tm
for the treatment of schizophrenia. On May 6, 2009, the FDA
granted U.S. marketing approval of
Fanapt
tm
for the acute treatment of
22
schizophrenia in adults. We expect to commercialize
Fanapt
tm
with our own sales force
and/or
commercial partners in the United States and to seek partners
for commercialization of the compound outside of the United
States. We plan to make
Fanapt
tm
available in pharmacies in the United States prior to the end of
2009. Holders of an NDA have 60 days after approval to file
for patent term restoration under the Hatch-Waxman Act. We
submitted our application for patent term restoration with
respect to
Fanapt
tm
on June 9, 2009. On July 30, 2009, we signed a
Medicaid Rebate Agreement with the Secretary of Health and Human
Services relating to the sale of
Fanapt
tm
to Medicaid patients.
Tasimelteon, a compound for the treatment of sleep and mood
disorders, including Circadian Rhythm Sleep Disorders (CRSD). In
November 2006, we announced positive top-line results from the
Phase III trial of tasimelteon in transient insomnia. In
June 2008, we announced positive top-line results from the
Phase III trial of tasimelteon in chronic primary insomnia.
In addition, we believe that tasimelteon may be effective in the
treatment of insomnia caused by jet lag. We met with the FDA in
June 2009 for an end of Phase II meeting to discuss the
clinical development plan. We will continue to work with the FDA
to characterize the path to a NDA for tasmelteon. Tasimelteon is
also ready for Phase II trials for the treatment of
depression. Given the range of potential indications for
tasimelteon, we intend to pursue one or more partnerships for
the development and commercialization of tasimelteon worldwide.
23
24
Period from
March 13,
2003
Three Months Ended
Six Months Ended
(Inception) to
June 30,
June 30,
June 30,
June 30,
June 30,
2009
2008
2009
2008
2009
$
6,031,000
$
2,090,000
$
7,467,000
$
4,417,000
$
81,996,000
662,000
2,179,000
1,112,000
9,764,000
52,422,000
1,000
281,000
558,000
6,711,000
25,000
465,000
77,000
945,000
6,648,000
6,719,000
5,015,000
8,656,000
15,684,000
147,777,000
141,000
222,000
312,000
369,000
2,574,000
59,000
110,000
122,000
178,000
2,138,000
277,000
134,000
439,000
353,000
6,625,000
477,000
466,000
873,000
900,000
11,337,000
$
7,196,000
$
5,481,000
$
9,529,000
$
16,584,000
$
159,114,000
(1)
Many of our research and development costs are not attributable
to any individual project because we share resources across
several development projects. We record direct costs, including
personnel costs and related benefits and stock-based
compensation, on a
project-by-project
basis. We record indirect costs that support a number of our
research and development activities in the aggregate.
25
26
Three Months Ended
Six Months Ended
June 30,
June 30,
June 30,
June 30,
2009
2008
2009
2008
$
582,000
$
697,000
$
810,000
$
1,852,000
2,172,000
3,270,000
4,247,000
7,234,000
$
2,754,000
$
3,967,000
$
5,057,000
$
9,086,000
27
Three Months Ended
June 30,
June 30,
2009
2008
$
14,000
$
1,034,000
5,594,000
2,181,000
529,000
1,103,000
582,000
697,000
6,719,000
5,015,000
477,000
466,000
$
7,196,000
$
5,481,000
28
Three Months Ended
June 30,
June 30,
2009
2008
$
501,000
$
1,099,000
2,172,000
3,270,000
1,688,000
3,300,000
627,000
786,000
$
4,988,000
$
8,455,000
Six Months Ended
June 30,
June 30,
2009
2008
$
35,000
$
7,198,000
6,782,000
4,420,000
1,029,000
2,214,000
810,000
1,852,000
8,656,000
15,684,000
873,000
900,000
$
9,529,000
$
16,584,000
29
Six Months Ended
June 30,
June 30,
2009
2008
$
967,000
$
2,089,000
4,247,000
7,234,000
2,831,000
6,518,000
1,167,000
1,573,000
$
9,212,000
$
17,414,000
June 30, 2009
Estimated
Gross
Net
Useful
Carrying
Accumulated
Carrying
Lives
Amount
Amortization
Amount
8 years
$
12,000,000
$
229,000
$
11,771,000
$
12,000,000
$
229,000
$
11,771,000
30
June 30,
2009
$
1,272,000
$
1,272,000
June 30,
December 31,
2009
2008
$
24,014,000
$
39,079,000
4,009,000
2,000,000
1,000,000
5,252,000
127,000
5,009,000
7,379,000
$
29,023,000
$
46,458,000
$
430,000
$
430,000
31
Level 1 defined as observable inputs such as
quoted prices in active markets
Level 2 defined as inputs other than quoted
prices in active markets that are either directly or indirectly
observable
Level 3 defined as unobservable inputs in which
little or no market data exists, therefore requiring an entity
to develop its own assumptions
Fair Value Measurements at Reporting Date Using
Quoted Prices in
Active Markets
Significant Other
Significant
for Identical
Observable
Unobservable
Assets
Inputs
Inputs
June 30, 2009
(Level 1)
(Level 2)
(Level 3)
$
5,009,000
$
4,009,000
$
1,000,000
$
$
5,009,000
$
4,009,000
$
1,000,000
$
Fair Value Measurements at Reporting Date Using
Quoted Prices in
Active Markets
Significant Other
Significant
for Identical
Observable
Unobservable
Assets
Inputs
Inputs
December 31, 2008
(Level 1)
(Level 2)
(Level 3)
$
7,379,000
$
2,000,000
$
5,379,000
$
$
7,379,000
$
2,000,000
$
5,379,000
$
32
Six Months Ended
June 30,
June 30,
2009
2008
$
(11,242,000
)
$
(27,217,000
)
(4,706,000
)
41,774,000
883,000
17,000
$
(15,065,000
)
$
14,574,000
Cash Payments Due by Period
July to
December
After
Total
2009
2010
2011
2012
2013
2013
$
471,000
$
458,000
$
13,000
$
$
$
$
5,330,000
343,000
706,000
727,000
749,000
771,000
2,034,000
$
5,801,000
$
801,000
$
719,000
$
727,000
$
749,000
$
771,000
$
2,034,000
33
Six Months Ended June 30, 2009
Beginning Balance
Charge
Cash Paid
Ending Balance
$
571,000
$
$
402,000
$
169,000
1,041,000
739,000
302,000
$
1,612,000
$
$
1,141,000
$
471,000
34
Item 3.
Quantitative
and Qualitative Disclosures about Market Risk.
35
Item 4.
Controls
and Procedures.
36
Item 1.
Legal
Proceedings.
Item 1A.
Risk
Factors
the ability of patients in the current uncertain economic
climate to be able to afford
Fanapt
tm
or obtain health care coverage that covers
Fanapt
tm
acceptance of and ongoing satisfaction with
Fanapt
tm
in the United States and foreign markets by the medical
community, patients receiving therapy and third party payers
a satisfactory efficacy and safety profile as demonstrated in a
broad patient population
successfully expanding and sustaining manufacturing capacity to
meet demand
safety concerns in the marketplace for schizophrenia therapies
the competitive landscape for approved and developing therapies
that will compete with
Fanapt
tm
our ability to expand the indications for which we can market
Fanapt
tm
37
our inability to manufacture or obtain from third parties
materials sufficient for use in pre-clinical studies and
clinical trials
delays in patient enrollment and variability in the number and
types of patients available for clinical trials
difficulty in maintaining contact with patients after treatment,
resulting in incomplete data
poor effectiveness of products during clinical trials
unforeseen safety issues or side effects
governmental or regulatory delays and changes in regulatory
requirements and guidelines
a drug candidate may not be shown to be safe or effective
the FDA may interpret data from pre-clinical and clinical trials
in different ways than we do
the FDA may not approve our manufacturing process
the FDA may change their approval policies or adopt new
regulations
the FDA may not meet, or may extend, the PDUFA date with respect
to a particular NDA
warning letters
fines
civil penalties
38
injunctions
recall or seizure of products
total or partial suspension of production
refusal of the government to grant future approvals
withdrawal of approvals
criminal prosecution
39
regulatory authorities may require the addition of labeling
statements, such as a black box warning or a
contraindication
regulatory authorities may withdraw their approval of the product
we may be required to change the way the product is
administered, conduct additional clinical trials or change the
labeling of the product
our reputation may suffer
40
because most of our third-party manufacturers and formulators
are located outside of the United States, there may be
difficulties in importing our compounds or their components into
the United States as a
41
result of, among other things, FDA import inspections,
incomplete or inaccurate import documentation or defective
packaging
because of the complex nature of our products, our manufacturers
may not be able to successfully manufacture our products in a
cost-effective
and/or
timely manner
developing products
undertaking pre-clinical testing and clinical trials
obtaining FDA and other regulatory approvals of products
manufacturing and marketing products
For
Fanapt
tm
in the treatment of schizophrenia, the atypical antipsychotics
risperidone, including the depot formulation
Risperdal
®
Consta
®
,
and
Invega
®
(paliperidone), each by Ortho-McNeil-Janssen Pharmaceuticals,
Inc.,
Zyprexa
®
(olanzapine) by Eli Lilly and Company,
Seroquel
®
(quetiapine) by AstraZeneca PLC,
Abilify
®
(aripiprazole) by Bristol-Myers Squibb Company/Otsuka
Pharmaceutical Co., Ltd.,
Geodon
®
(ziprasidone) by Pfizer Inc., and generic clozapine, as well as
the typical antipsychotics haloperidol, chlorpromazine,
thioridazine, and sulpiride (all of which are generic). In
addition to the approved products, compounds in Phase III
trials (or for which an NDA has been recently filed) for the
treatment of schizophrenia include bifeprunox (Solvay
S.A./Lundbeck A/S), and asenapine (Schering-Plough Corporation)
and pimavanserin (Acadia Pharmaceuticals).
For tasimelteon in the treatment of insomnia,
Rozerem
tm
(ramelteon)
by Takeda Pharmaceuticals Company Limited, hypnotics such as
Ambien
®
CR (zolpidem) by sanofi-aventis,
Lunesta
®
(eszopiclone) by Sepracor Inc. and
Sonata
®
(zaleplon) by King Pharmaceuticals, Inc., generic compounds such
as zolpidem, trazodone and doxepin, and
over-the-counter
remedies such as
Benadryl
®
and Tylenol
PM
®
.
In addition to the approved products, compounds in
Phase III trials for insomnia (or for which an
42
NDA has been recently filed) include indiplon (Neurocrine
Biosciences, Inc.) low-dose doxepin
(Silenor
tm
)
by Somaxon Pharmaceuticals, Inc. and
Intermezza
®
(zolpidem tartarate sublingual lozenge) by Transcept
Pharmaceuticals, Inc.
For tasimelteon in the treatment of depression, generic
antidepressants such as paroxetine, sertraline, fluoxetine and
buproprion,
Lexapro
®
(escitalopram) by Lundbeck A/S /Forest Pharmaceuticals Inc., and
Effexor
®
(venlafaxine) by Wyeth as well as other compounds such as
Cymbalta
®
(duloxetine) by Eli Lilly and Valdoxan (agomelatine) by Novartis
and Les Laboratories Servier.
our inability to recruit and retain adequate numbers of
effective sales and marketing personnel
the inability of sales personnel to obtain access to or persuade
adequate numbers of physicians to prescribe our products
the lack of complementary products to be offered by our sales
personnel, which may put us at a competitive disadvantage
against companies with broader product lines
unforeseen costs associated with creating our own sales and
marketing team or with entering into a partnering agreement with
an independent sales and marketing organization
manage our clinical trials effectively
manage our internal development efforts effectively
improve our operational, financial, accounting and management
controls, reporting systems and procedures
build marketing and sales organizations in order to
commercialize
Fanapt
tm
attract and retain sufficient numbers of talented employees
43
44
our addition or termination of development programs
variations in the level of expenses related to our products or
future development programs
our execution of collaborative, licensing or other arrangements,
and the timing of payments we may make or receive under these
arrangements
any intellectual property infringement lawsuit in which we may
become involved
regulatory developments affecting our products or those of our
competitors
product sales
cost of product sales
marketing and other expenses
manufacturing or supply issues
45
46
47
publicity regarding actual or potential testing or trial results
relating to products under development by us or our competitors
the outcome of regulatory review relating to products under
development by us or our competitors
regulatory developments in the United States and foreign
countries
developments concerning any collaboration or other strategic
transaction we may undertake
announcements of patent issuances or denials, technological
innovations or new commercial products by us or our competitors
safety issues with our products
our ability to successfully execute our commercialization
strategies
actual or anticipated variations in our quarterly operating
results
changes in estimates of our financial results or recommendations
by securities analysts
48
additions or departures of key personnel or members of our board
of directors
publicity regarding actual or potential transactions involving
the Company
economic and other external factors beyond our control
authorize the issuance of blank check preferred
stock that could be issued by our board of directors to thwart a
takeover attempt
do not provide for cumulative voting in the election of
directors, which would allow holders of less than a majority of
the stock to elect some directors
establish a classified board of directors, as a result of which
the successors to the directors whose terms have expired will be
elected to serve from the time of election and qualification
until the third annual meeting following their election
require that directors only be removed from office for cause
49
provide that vacancies on the board of directors, including
newly-created directorships, may be filled only by a majority
vote of directors then in office
limit who may call special meetings of stockholders
prohibit stockholder action by written consent, requiring all
actions to be taken at a meeting of the stockholders
establish advance notice requirements for nominating candidates
for election to the board of directors or for proposing matters
that can be acted upon by stockholders at stockholder meetings
Item 2.
Unregistered
Sales of Equity Securities and Use of Proceeds.
Item 3.
Defaults
Upon Senior Securities.
Item 4.
Submission
of Matters to a Vote of Security Holders.
Item 5.
Other
Information.
50
Item 6.
Exhibits
Exhibit
10
.33
Amended and Restated Employment Agreement for William D. Clark.
10
.34
Amended and Restated Employment Agreement for Mihael H.
Polymeropoulos.
10
.35
Employment Agreement for Stephanie Irish.
10
.36
Employment Agreement for John Feeney.
31
.1
Certification of the Principal Executive Officer, as required by
Section 302 of the Sarbanes-Oxley Act of 2002.
31
.2
Certification of the Principal Financial Officer, as required by
Section 302 of the Sarbanes-Oxley Act of 2002.
32
.1
Certification of the Chief Executive Officer and Acting Chief
Financial Officer, as required by Section 906 of the
Sarbanes-Oxley Act of 2002.
51
52
Exhibit
31
.1
Certification of the Principal Executive Officer, as required by
Section 302 of the Sarbanes-Oxley Act of 2002.
31
.2
Certification of the Principal Financial Officer, as required by
Section 302 of the Sarbanes-Oxley Act of 2002.
32
.1
Certification of the Chief Executive Officer and Acting Chief
Financial Officer, as required by Section 906 of the
Sarbanes-Oxley Act of 2002.
53
1 | Certain capitalized terms are defined in Section 9. |
2
3
4
5
6
7
/s/ William D. Clark | ||||
William D. Clark | ||||
Vanda Pharmaceuticals Inc.
|
||||
By | /s/ Mihael H. Polymeropoulos | |||
Title: President and Chief Executive Officer | ||||
8
1 | Certain capitalized terms are defined in Section 9. |
2
3
4
5
6
7
/s/ Mihael H. Polymeropoulos | ||||
Mihael H. Polymeropoulos | ||||
Vanda Pharmaceuticals Inc.
|
||||
By | /s/ Stephanie R. Irish | |||
Title: Acting Chief Financial Officer | ||||
8
1 | Certain capitalized terms are defined in Section 9. |
2
3
4
5
6
7
8
/s/ Stephanie R. Irish | ||||
Stephanie R. Irish | ||||
Vanda Pharmaceuticals Inc.
|
||||
By | /s/ Mihael H. Polymeropoulos | |||
Title: President and Chief Executive Officer | ||||
9
1 | Certain capitalized terms are defined in Section 9. |
2
3
4
5
6
7
8
/s/ John Feeney | ||||
John Feeney | ||||
Vanda Pharmaceuticals Inc.
|
||||
By | /s/ Mihael H. Polymeropoulos | |||
Title: President and Chief Executive Officer | ||||
9
Date: August 10, 2009
|
/s/ Mihael H. Polymeropoulos
|
|
Mihael H. Polymeropoulos
Chairman and Chief Executive Officer (Principal Executive Officer) |
Date: August 10, 2009
|
/s/ Stephanie R. Irish
|
|
Stephanie R. Irish
Acting Chief Financial Officer (Principal Financial and Accounting Officer) |
Date: August 10, 2009
|
/s/ Mihael H. Polymeropoulos
|
|
Mihael H. Polymeropoulos
Chairman and Chief Executive Officer (Principal Executive Officer) |
Date: August 10, 2009
|
/s/ Stephanie R. Irish
|
|
Stephanie R. Irish
Acting Chief Financial Officer (Principal Financial and Accounting Officer) |