(Mark One) | ||
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE
ACT OF 1934 |
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For the fiscal year ended December 31, 2009 | ||
or
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES
EXCHANGE ACT OF 1934 |
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For the transition period from to |
Washington
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91-1663741 | |
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification Number) |
1420 Fifth Avenue, Suite 2600
Seattle, Washington |
98101
(Zip Code) |
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(Address of principal executive
offices)
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Common Stock, $0.01 par value per share
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1
ITEM 1.
BUSINESS
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Product
Targeted
Expected Near-Term
Worldwide
Candidate/Program
Procedure/Disease
Development Status
Milestone (1)
Rights
Arthroscopic ACL reconstruction
Phase 3
Complete Phase 3 trials
Omeros
Arthroscopic meniscectomy
Phase 2 completed
Design Phase 3 clinical program
Omeros
Cataract surgery
Phase 2
Begin enrollment in
second Phase 2 trial
Omeros
Ureteroscopy
Phase 1/2
Complete Phase 1/2 trial
Omeros
Addiction and other compulsive behaviors
Phase 2
Begin enrollment in
Phase 2 trial
Omeros
Macular degeneration, ischemia-reperfusion injury, transplant
surgery
Preclinical
Select clinical candidate
In-licensed (2)
Schizophrenia
Preclinical
Select clinical candidate
Omeros
Parkinsons disease, Restless Legs Syndrome
Preclinical
Select clinical candidate
Omeros
Multiple disorders
Platform
Surrogate de-
orphanization of orphan
GPCRs
Omeros
(1)
Following selection of a clinical candidate, we must conduct
additional studies, including in vivo toxicity studies of the
clinical candidate. We must submit the results of these studies,
together with manufacturing information and analytical results
related to the clinical candidate, to the FDA as part of an IND,
which must become effective before we may commence clinical
trials. Submission of an IND does not always result in the FDA
allowing clinical trials to commence. Depending on the nature of
information that we must obtain and include in an IND, it may
take from 12 to 24 months from selection of the clinical
candidate to IND submission, if it occurs at all. All of these
expected near-term milestones are subject to a number of risks,
uncertainties and assumptions, including those described in
Risk Factors, and may not occur in the timelines set
forth above or at all.
(2)
We hold worldwide exclusive licenses to rights in connection
with MASP-2, the antibodies targeting MASP-2 and the therapeutic
applications for those antibodies from the University of
Leicester and from its collaborator, Medical Research Council at
Oxford University.
Obtain regulatory approval for our late-stage PharmacoSurgery
product candidates
.
Maximize commercial opportunity for our PharmacoSurgery
product candidates.
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Mitigate risk by combining our multiple late-stage
PharmacoSurgery product candidates with our deep and diverse
pipeline of clinical and preclinical development programs as
well as our GPCR program.
Further expand our broad patent portfolio.
Manage our business with continued efficiency and
discipline
.
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alterations in vascular caliber, or vasodilation, that lead to
an increase in blood flow;
structural changes in the microvasculature that permit plasma
proteins to leave the circulation, or plasma
extravasation; and
white cell migration from the microcirculation to the site of
tissue injury.
Ketoprofen
, a non-steroidal anti-inflammatory drug, or
NSAID, is a non-selective inhibitor of the
pro-inflammatory
mediators COX-1 and COX-2, with potent anti-inflammatory and
analgesic actions that result from inhibiting the synthesis of
the pro-inflammatory mediator PGE2, and antagonizing the effects
of bradykinin, another inflammatory mediator;
Amitriptyline
is a compound with analgesic activity that
inhibits the pro-inflammatory actions of histamine and serotonin
released locally at the site of tissue trauma; and
Oxymetazoline
is a vasoconstrictor and also activates
serotonin receptors, located on a group of nerve fibers called
primary afferents, that can inhibit the release of
proinflammatory mediators such as substance P and calcitonin
gene-related peptide, or CGRP.
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If approved, OMS103HP will be the first commercially available
drug delivered directly to the surgical site to improve function
following arthroscopic surgery.
OMS103HP will provide additional postoperative clinical
benefits, including improved range of motion, reduced pain and
earlier return to work.
OMS103HP selectively targets multiple and discrete
pro-inflammatory mediators and pathways within the inflammatory
and pain cascade.
By delivering OMS103HP to the joint at the initiation of
surgical trauma, the inflammatory and pain cascade will be
preemptively inhibited.
Intra-operative delivery to the joint creates a constant
concentration of OMS103HP, bathing and replenishing the joint
with drug throughout the duration of the surgical procedure.
Because OMS103HP is delivered locally to, and acts directly at,
the site of tissue injury, it can be delivered in low
concentration, and will not be subject to the substantial
interpatient variability in metabolism that is associated with
systemic delivery.
By delivering low-concentration OMS103HP locally and only during
the arthroscopic procedure, systemic absorption of the APIs will
be minimized or avoided, thereby reducing the risk of adverse
side effects.
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Figure 2: Median Last Day of Continuous Passive Motion
Machine Use was Earlier for OMS103HP-Treated Patients
*p = 0.007, log rank
Figure 1 depicts the median number
of days to maximum passive flexion
³
90° without pain, which
is a knee range of motion test, as measured in the clinic.
Figure 2 depicts the number of days
until the continuous passive motion, or CPM, machine was
discontinued. CPM machines are often used postoperatively to
move the knee through a range of motion. CPM usage, recorded in
the patient diary, was discontinued at the direction of either
the surgeon or rehabilitation therapist based on the
patients progress, usually at the time the patient
reproducibly attained at least 90° of flexion of the
operated knee. CPM machine usage was significantly less for
OMS103HP.
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Figure 6: A Greater Percentage of OMS103HP-Treated
Patients Demonstrated Very Good
and Good Ratings on the Knee Function
CompositeStraight-Leg Raise
*p = 0.009, Wilcoxon rank sum test
Figure 5 depicts the studys
primary endpoint, the Knee Function Composite, or KFC. The KFC
is composed of the straight-leg raise, one-leg stance, shuttle
press, and two-leg squat. Each test is a direct measure of knee
function, and all four are routinely used by orthopedic surgeons
and rehabilitation therapists to measure improvement in knee
function during the early postoperative period following ACL
reconstruction surgery. Success on the KFC requires success on
all four of the component tests by the end of the
30-day
evaluation period.
Very
Good
: Achievement
of the KFC by the end of the 30-day evaluation period and
achievement of the highest level of straight-leg raise, or SLR,
by the 13th day after surgery
Good:
Achievement of the KFC by the end of the
30-day evaluation period without achievement of the highest
level of SLR by the 13th day after surgery
Poor
: Failure to achieve the KFC by the end of the
30-day evaluation period
Figure 6 depicts the Knee Function
Composite Straight-Leg Raise, or KFC-SLR, which
combines the successful achievement of the KFC with a second key
rehabilitation milestone, the ability to perform the highest
level of the straight-leg raise by the 13th day after
surgery following ACL reconstruction surgery. While the KFC
accurately assesses knee function throughout the first 30-day
period of postoperative rehabilitation therapy, an evaluation of
postoperative function within the first two weeks also is
important because early functional return is considered a key
driver in successful post-arthroscopy outcomes. Of the four
tests comprising the KFC, the straight-leg raise is the most
important in the first two weeks following ACL reconstruction
because it is used to determine the pace to progress
exercises.(
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*p = 0.031, FET
*p = 0.048; log-rank test
Figure 7 depicts the percentage of
patients achieving Successful Pain Management, or SPM, which is
a composite of pain assessment and narcotic usage based on data
from clinic visits and the patient diary. The SPM composite sets
two criteria that the patient must meet in order to be
considered a responder. During the first postoperative week, at
all clinic visits, the VAS pain score must be not greater than
20 mm with the operated knee at rest. A maximum of two narcotic
tablets could be self-administered on each day during the first
postoperative week. VAS pain scores of 20 mm or less are
considered to be indicative of good to excellent pain control
not requiring analgesic medication. The SPM allows pain
assessments and narcotic use to be evaluated together, and
provides a more complete evaluation of pain management than
either VAS pain scores or narcotic usage considered individually
because a low VAS pain score recorded by a patient taking high
doses of opioid pain medications does not reflect the same level
of pain management as that same low VAS pain score recorded in
the absence of narcotic pain medications.
Figure 8 depicts results related to
patients ability to return to work following ACL
reconstruction surgery. Patients were considered to have
returned to work if they reported in the patient diary that they
had gone to work outside of the home on two consecutive work
days excluding weekends and holidays. Return to work was
considered to have begun on the first of the two consecutive
days. Patients who were unemployed or not working for pay were
excluded from the analysis.
As published in
Arthroscopy: The
Journal of Arthroscopic and Related Surgery, Vol. 24, No. 6
(June), 2008: pp. 625-636.
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The anti-inflammatory API in OMS302 inhibits miosis by blocking
the synthesis of prostaglandins caused by surgical trauma.
By delivering OMS302 intra-operatively, inflammation and
discomfort will be reduced during the first 24 hours
following surgery, the time during which anti-inflammatory
topical drops are not commonly administered, as well as after
this initial postoperative period.
Intra-operative delivery of the mydriatic API in OMS302 will
maintain pupil dilation throughout the surgical procedure,
decreasing the risk of surgical damage to structures within the
eye.
Because the mydriatic API in OMS302 maintains pupil dilation,
OMS302 will increase the ease of the surgical procedure, thereby
increasing patient throughput for both the surgeon and the
surgical facility.
The mydriatic API in OMS302 prevents intra-operative floppy iris
syndrome in many patients taking alpha adrenergic antagonists,
such as
FLOMAX
®
.
Because OMS302 is delivered intracamerally in standard
irrigation solution at a constant, defined concentration,
maintaining a more consistent local tissue exposure during the
surgical procedure, it will provide superior efficacy relative
to topical drug products containing either API.
OMS302 is delivered locally to, and acts directly at, the site
of tissue injury and, therefore, can be delivered in low
concentrations, and will not be subject to the substantial
interpatient variability in pharmacokinetics that is associated
with systemic delivery.
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By delivering OMS201 intra-operatively, it will reduce
inflammation, pain, smooth muscle spasm and lower urinary tract
symptoms including frequency, urgency and painful urination, and
improve patient outcomes.
OMS201 will save health care costs and increase patient comfort
by reducing the incidence of ureteral occlusion and the routine
need for ureteral stents.
By targeting inflammation and smooth muscle spasm, OMS201 will
permit surgeons to more frequently place a standard larger-sized
UAS, decreasing intra-operative trauma and shortening operative
time, thereby saving costs.
OMS201 is delivered locally to, and acts directly at, the site
of tissue injury and, therefore, can be delivered in low
concentrations, and will not be subject to the substantial
interpatient variability in pharmacokinetics that is associated
with systemic delivery.
By delivering OMS201 locally and only during the uroendoscopic
procedure, systemic absorption of the APIs will be minimized or
avoided, thereby reducing the risk of adverse side effects.
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Ischemia-Reperfusion Injury
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We will be required to pay Patobios a $500,000 CAD
de-orphanization milestone payment, which will be credited in
full against the cash portion of the asset purchase price should
we exercise our option to purchase Patobios assets related
to the CRA;
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We may license, partner or assign therapeutic development
and/or
commercialization rights associated with up to three
de-orphanized orphan GPCRs to third parties, or the Third-Party
Licenses, subject to Patobios approval of the scope of
such Third Party Licenses (Third Party Licenses for any
additional de-orphanized orphan GPCRs would require prior
approval from Patobios);
If we grant any Third-Party Licenses, then until the agreement
with Patobios is terminated or we purchase the assets, whichever
occurs first, we are required to pay Patobios 60% of any license
proceeds that we receive from such Third-Party Licenses, subject
to certain exceptions, which amounts would be credited in full
against the purchase price of the assets related to the CRA;
If our agreement with Patobios is terminated before we purchase
the CRA assets, thereafter we will share equally with Patobios
any proceeds from Third-Party Licenses;
Patobios may require us to purchase the CRA assets for the
approximately $10.8 million CAD purchase price, provided
that we will not be required to purchase the assets until the
sum of the following items is at least equal to
$5.135 million CAD: (a) the amount we have paid to
Patobios from the Third-Party Licenses, (b) the amount of
any government or non-profit funding that we have received and
that is specifically allocated for the purchase of the assets
and (c) the $500,000 CAD de-orphanization milestone payment;
We may not terminate the agreement for convenience during an
option period for which we have elected to pay an option fee and
none of the option fees paid will be refundable to us except in
case of a breach of the agreement by Patobios; and
If by June 4, 2010 we have de-orphanized at least one
orphan GPCR but have not purchased the CRA assets, we will be
required to extend the option period until December 4, 2010
at a cost of $500,000 CAD.
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develop and market products that are less expensive, more
effective or safer than our future products;
commercialize competing products before we can launch any
products developed from our product candidates;
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operate larger research and development programs, possess
greater manufacturing capabilities or have substantially greater
financial resources than we do;
initiate or withstand substantial price competition more
successfully than we can;
have greater success in recruiting skilled technical and
scientific workers from the limited pool of available talent;
more effectively negotiate third-party licenses and strategic
relationships; and
take advantage of acquisition or other opportunities more
readily than we can.
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OMS103HPArthroscopy.
OMS103HP is encompassed
by our PharmacoSurgery patent portfolio. The relevant patents
and patent applications in this portfolio cover combinations of
agents, generic
and/or
proprietary to us or others, drawn from therapeutic classes such
as pain and inflammation inhibitory agents and vasoconstrictive
agents, delivered locally and intra-operatively to the site of
medical or surgical procedures, including arthroscopy. As of
March 1, 2010, we owned four issued U.S. Patents, two
pending U.S. Patent Applications, and 12 issued patents and
8 pending patent applications in foreign markets (Australia,
Brazil, Canada, China, Europe, Hong Kong, Japan, Mexico, Norway,
Russia, Singapore and South Korea) that cover OMS103HP.
OMS302Ophthalmology.
OMS302 is encompassed by
our PharmacoSurgery patent portfolio. The relevant patents and
patent applications in this portfolio cover combinations of
agents, generic
and/or
proprietary to us or others, drawn from therapeutic classes such
as pain and inflammation inhibitory agents, mydriatic agents and
agents that reduce intraocular pressure, delivered locally and
intra-operatively to the site of ophthalmological procedures,
including cataract and lens replacement surgery. As of
March 1, 2010, we owned two pending U.S. Patent
Applications and two issued patents and 10 pending patent
applications in foreign markets (Australia, Canada, China,
Europe, Hong Kong and Japan) that cover OMS302.
OMS201Urology.
OMS201 is encompassed by our
PharmacoSurgery patent portfolio. The relevant patents and
patent applications in this portfolio cover combinations of
agents, generic
and/or
proprietary to us or others, drawn from therapeutic classes such
as pain and inflammation inhibitory agents and spasm inhibitory
agents, delivered locally and intra-operatively to the site of
medical or surgical procedures, including uroendoscopy. As of
March 1, 2010, we owned three issued U.S. Patents, two
pending U.S. Patent Applications, and an additional 10
issued patents and 15 pending patent applications in foreign
markets (Australia, Brazil, Canada, China, Europe, Hong Kong,
India, Japan, Mexico, Norway, Russia, Singapore and South Korea)
that cover OMS201.
MASP-2 Program.
We hold worldwide exclusive licenses
to rights in connection with MASP-2, the antibodies targeting
MASP-2 and the therapeutic applications for those antibodies
from the University of Leicester and from its collaborator,
Medical Research Council at Oxford University. These licenses
include what we believe to be each institutions joint
ownership rights in patent applications and patents related to
MASP-2 antibodies initially filed by researchers at Aarhus
Universitet, Denmark. As of March 1, 2010, we exclusively
controlled five pending U.S. Patent Applications and 21
pending patent applications in foreign markets (Australia,
Brazil, Canada, China, Hong Kong, Europe, India, Indonesia,
Japan, Mexico, New Zealand, Russia and South Korea) related to
our MASP-2 program.
Addiction Program.
As of March 1, 2010, we
owned three pending U.S. Patent Applications and 11 pending
patent applications in foreign markets (Australia, Brazil,
Canada, China, Europe, India, Japan, Mexico, New Zealand, Russia
and South Korea) directed to the recently discovered link
between PPARγ and addictive disorders.
PDE10 Program.
Medicinal chemistry developments in
our PDE10 program have resulted in two pending U.S., one pending
European and two pending PCT Patent Applications as of
March 1, 2010 that claim what we believe to be novel
chemical structures, as well as claiming the use of a broader
set, or genus, of chemical structures as inhibitors of PDE10 for
the treatment of schizophrenia and other psychotic disorders.
PDE7 Program.
As of March 1, 2010, we owned two
pending U.S. Patent Applications and ten pending patent
applications in foreign markets (Australia, Brazil, Canada,
China, Europe, India,
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Japan, Mexico, New Zealand and Russia) directed to the
previously unknown link between PDE7 and movement disorders.
GPCR Program.
As of March 1, 2010, we owned one
issued U.S. Patent, three pending U.S. Patent
Applications, and two issued patents and two pending patent
applications in foreign markets (Australia, Europe and Japan),
which are directed to previously unknown links between specific
molecular targets in the brain and a series of CNS disorders,
and to research tools that are used in our GPCR program.
PharmacoSurgery Platform.
Our scientific
co-founders, Gregory A. Demopulos, M.D. and Pamela Pierce
Palmer, M.D., Ph.D., conceived the initial invention
underlying our PharmacoSurgery platform and transferred all of
their related intellectual property rights to us in 1994. Other
than their rights as shareholders, our co-founders have not
retained any rights to our PharmacoSurgery platform, except that
if we file for liquidation under Chapter 7 of the
U.S. Bankruptcy Act or voluntarily liquidate or dissolve,
other than in connection with a merger, reorganization,
consolidation or sale of assets, our co-founders have the right
to repurchase the initial PharmacoSurgery intellectual property
at the then-current fair market value. Subsequent developments
of the PharmacoSurgery intellectual property were assigned to us
by Dr. Demopulos, Dr. Palmer and other of our
employees and consultants, without restriction.
MASP-2 Program.
We hold worldwide exclusive licenses
to rights related to MASP-2, the antibodies targeting MASP-2 and
the therapeutic applications for the antibodies from the
University of Leicester and from its collaborator, Medical
Research Council at Oxford University, or MRC. Concurrent with
execution of the license agreement with the University of
Leicester, two provisional US Patent Applications directed to
methods of treating conditions associated with complement
activation by inhibiting MASP-2 or a related protein, and a
British application directed to MASP-2 knock-out mice, were
filed. Exclusive licenses to these three initial patent
applications were conveyed to us by
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the University of Leicester license agreement. For a more
detailed description of these licenses, see
BusinessOur Product Candidates and Development
ProgramsMASP-2 Program.
Addiction Program.
We acquired the patent
applications and related intellectual property rights for our
Addiction program in 2009 from Roberto Ciccocioppo, Ph.D.
of the Università di Camerino, Italy, pursuant to a Patent
Assignment Agreement. We have agreed to pay Dr. Ciccocioppo
royalties and milestone payments related to any products that
are covered by the patents we acquired from him. For a more
detailed description of this agreement, see
BusinessOur Product Candidates and Development
ProgramsAddiction Program.
PDE10, PDE7 and GPCR Programs.
We acquired our
PDE10, PDE7 and GPCR programs and some of our related patents
and other intellectual property rights as a result of our
acquisition of nura, inc. in August 2006 for an aggregate
purchase price of $14.4 million. We hold an exclusive
license to certain PDE7 inhibitors claimed in patents and
pending patent applications owned by Asubio Pharma Co., Ltd. for
use in the treatment of movement disorders and other specified
indications. We also hold an exclusive option to purchase the
CRA for our GPCR program from Patobios Limited for approximately
$10.8 million CAD. For a more detailed description of our
agreement with Asubio, see BusinessOur Product
Candidates and Development ProgramsPDE7 Program, and
for a more detailed description of our agreement with Patobios,
see BusinessOur Product Candidates and Development
ProgramsGPCR Program.
The steps required before a drug product may be approved by the
FDA generally include the following:
preclinical laboratory and animal tests, and formulation studies;
submission to the FDA of an Investigational New Drug
Application, or IND, for human clinical testing, which must
become effective before human clinical trials may begin in the
United States;
adequate and well-controlled human clinical trials to establish
the efficacy and safety of the product candidate for each
indication for which approval is sought;
submission to the FDA of a New Drug Application, or NDA;
satisfactory completion of an FDA inspection of the
manufacturing facility or facilities at which the drug is
produced to assess compliance with cGMP; and
FDA review and approval of an NDA.
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Phase 1 usually involves the initial administration of the
investigational drug product to human subjects to evaluate its
safety, dosage tolerance, pharmacodynamics and, if possible, to
gain an early indication of its effectiveness.
Phase 2 usually involves trials in a limited patient population,
with the disease or condition for which the product candidate is
being developed, to evaluate dosage tolerance and appropriate
dosage, identify possible adverse side effects and safety risks,
and preliminarily evaluate the effectiveness of the drug for
specific indications.
Phase 3 trials usually further evaluate effectiveness and test
further for safety by administering the drug in its final form
in an expanded patient population.
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Name
Position(s)
51
President, Chief Executive Officer and Chairman of the Board of
Directors
50
Vice President, Patent and General Counsel and Secretary
49
Vice President, Business Development
53
Vice President, Science
50
Vice President, Pharmaceutical Operations
65
Vice President, Regulatory Affairs and Quality Systems
51
Vice President, Research
42
Director of Finance and Controller
54
Vice President, Clinical Development and Chief Medical Officer
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our ability to release the results from our ongoing Phase 3
clinical trials of OMS103HP during the second half of 2010;
our ability to market OMS103HP by 2011, at the earliest;
our ability to initiate a second Phase 2 clinical trial for
OMS302 in patients undergoing cataract surgery in mid-2010;
our ability to complete the Phase 1/Phase 2 clinical trial of
OMS201 in patients undergoing ureteroscopic removal or ureteral
or renal stones in the second quarter of 2010;
our expectation that enrollment in a Phase 2 clinical study in
our Addiction program will begin in the first half of 2010;
our expectations regarding the clinical benefits of our product
candidates, including whether OMS103HP will be the first
commercially available drug delivered directly to the surgical
site to improve function following arthroscopic surgery;
our expectations regarding the growth in the number of
arthroscopic, cataract and uroendoscopic operations, the rates
at which each of our PharmacoSurgery product candidates will be
reimbursed to the surgical facility for its utilization and to
the surgeon for its use, the size of the markets for our
PharmacoSurgery product candidates and the rate and degree of
adoption and market penetration of our PharmacoSurgery product
candidates;
our ability to obtain commercial supplies of our PharmacoSurgery
product candidates, our competition and, if approved, our
ability to successfully commercialize our PharmacoSurgery
product candidates with a limited, hospital-based marketing and
sales force;
the extent of protection that our patents provide and our
pending patent applications may provide, if patents issue from
such applications, to our technologies and programs;
our estimate regarding how long our existing cash, cash
equivalents and short-term investments will be sufficient to
fund our anticipated operating expenses, capital expenditures
and note payments;
our expected financial position, performance, growth, expenses,
the magnitude of our net losses and the availability of
resources;
our involvement in potential claims and legal proceedings, the
expected course and costs of existing claims and legal
proceedings, and the potential outcomes and effects of both
existing and potential claims and legal proceedings on our
business, prospects, financial condition and results of
operations;
our plans to file additional patent applications to enhance and
protect our existing intellectual property portfolio; and
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our estimates regarding our future net losses, revenues,
research and development expenses and general and administrative
expenses.
ITEM 1A.
RISK
FACTORS
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discussions with the FDA or comparable foreign authorities
regarding the scope or design of our clinical trials;
delays or the inability to obtain required approvals from IRBs
or other governing entities at clinical sites selected for
participation in our clinical trials;
delays in enrolling patients into clinical trials;
lower than anticipated retention rates of patients in clinical
trials;
the need to repeat or conduct additional clinical trials as a
result of problems such as inconclusive or negative results,
poorly executed testing or unacceptable design;
an insufficient supply of product candidate materials or other
materials necessary to conduct our clinical trials;
the need to qualify new suppliers of product candidate materials
for FDA and foreign regulatory approval;
an unfavorable FDA inspection or review of a clinical trial site
or records of any clinical investigation;
the occurrence of drug-related side effects or adverse events
experienced by participants in our clinical trials; or
the placement of a clinical hold on a trial.
failure to conduct the clinical trial in accordance with
regulatory requirements or our clinical protocols;
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inspection of the clinical trial operations or trial sites by
the FDA or other regulatory authorities resulting in the
imposition of a clinical hold;
unforeseen safety issues or any determination that a trial
presents unacceptable health risks; or
lack of adequate funding to continue the clinical trial,
including the incurrence of unforeseen costs due to enrollment
delays, requirements to conduct additional trials and studies
and increased expenses associated with the services of our
contract research organizations, or CROs, and other third
parties.
complete the Phase 3 clinical trials of OMS103HP for use in
arthroscopic ACL reconstruction surgery and begin related
commercialization activities;
initiate, conduct and complete the Phase 3 clinical trials of
OMS103HP for use in arthroscopic meniscectomy surgery, should we
elect to proceed with these Phase 3 clinical trials;
conduct and complete the clinical trials of OMS302 for use
during lens replacement surgery;
conduct and complete the clinical trials of OMS201 for use in
endoscopic surgery of the urological tract;
continue our research and development;
make milestone payments to our collaborators;
make principal and interest payments due under our debt facility
with BlueCrest Venture Finance Master Fund Limited, or
BlueCrest;
initiate and conduct clinical trials for other product
candidates; and
launch and commercialize any product candidates for which we
receive regulatory approval.
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our ability to provide acceptable evidence of safety and
efficacy;
availability, relative cost and relative efficacy of alternative
and competing treatments;
the effectiveness of our marketing and distribution strategy to,
among others, hospitals, surgery centers, physicians
and/or
pharmacists;
prevalence of the surgical procedure or condition for which the
product is approved;
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acceptance by physicians of each product as a safe and effective
treatment;
perceived advantages over alternative treatments;
relative convenience and ease of administration;
the availability of adequate reimbursement by third parties;
the prevalence and severity of adverse side effects;
publicity concerning our products or competing products and
treatments; and
our ability to obtain sufficient third-party insurance coverage.
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 hospitals, surgery centers, physicians
and/or
pharmacists to purchase, use or prescribe our approved product
candidates;
the lack of complementary products to be offered by sales
personnel, which may put us at a competitive disadvantage
relative to companies with more extensive product lines; and
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unforeseen costs and expenses associated with creating an
independent sales and marketing organization.
47
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48
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49
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50
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we might not have been the first to make the inventions covered
by any of our patents, if issued, or our pending patent
applications;
we might not have been the first to file patent applications for
these inventions;
others may independently develop similar or alternative
technologies or products or duplicate any of our technologies or
products;
it is possible that none of our pending patent applications will
result in issued patents or, if issued, these patents may not be
sufficient to protect our technology or provide us with a basis
for commercially viable products and may not provide us with any
competitive advantages;
if our pending applications issue as patents, they may be
challenged by third parties as not infringed, invalid or
unenforceable under U.S. or foreign laws;
if issued, the patents under which we hold rights may not be
valid or enforceable; or
we may develop additional proprietary technologies or products
that are not patentable and which are unlikely to be adequately
protected through trade secrets if, for example, a competitor
were to independently develop duplicative, similar or
alternative technologies or products.
51
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52
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53
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54
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develop and market products that are less expensive or more
effective than any future products developed from our product
candidates;
commercialize competing products before we can launch any
products developed from our product candidates;
operate larger research and development programs, possess
commercial-scale manufacturing operations or have substantially
greater financial resources than we do;
initiate or withstand substantial price competition more
successfully than we can;
have greater success in recruiting skilled technical and
scientific workers from the limited pool of available talent;
more effectively negotiate third-party licenses and strategic
relationships; and
take advantage of acquisition or other opportunities more
readily than we can.
55
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restrictions on such product candidates or manufacturing
processes;
withdrawal of the product candidates from the market;
voluntary or mandatory recalls;
fines;
suspension of regulatory approvals;
product seizures; or
injunctions or the imposition of civil or criminal penalties.
a covered benefit under its health plan;
safe, effective and medically necessary;
appropriate for the specific patient;
cost-effective; and
neither experimental nor investigational.
56
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results from our clinical trial programs, including our ongoing
Phase 3 clinical trials for OMS103HP for use in ACL
reconstruction surgery, our ongoing Phase 2 clinical trial for
OMS302, our ongoing Phase 1/Phase 2 clinical trial for OMS201,
and our ongoing Phase 2 clinical trial for our Addiction program;
FDA or international regulatory actions, including failure to
receive regulatory approval for any of our product candidates;
failure of any of our product candidates, if approved, to
achieve commercial success;
quarterly variations in our results of operations or those of
our competitors;
our ability to develop and market new and enhanced product
candidates on a timely basis;
announcements by us or our competitors of acquisitions,
regulatory approvals, clinical milestones, new products,
significant contracts, commercial relationships or capital
commitments;
57
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third-party coverage and reimbursement policies;
additions or departures of key personnel;
commencement of, or our involvement in, litigation;
our ability to meet our repayment and other obligations under
our debt facility with BlueCrest, pursuant to which we have
borrowed $17.0 million;
changes in governmental regulations or in the status of our
regulatory approvals;
changes in earnings estimates or recommendations by securities
analysts;
any major change in our board or management;
general economic conditions and slow or negative growth of our
markets; and
political instability, natural disasters, war
and/or
events of terrorism.
58
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ITEM 1B.
UNRESOLVED
STAFF COMMENTS
ITEM 2.
PROPERTIES
ITEM 3.
LEGAL
PROCEEDINGS
59
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ITEM 4.
RESERVED
60
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F-18
ITEM 5.
MARKET
FOR REGISTRANTS COMMON EQUITY, RELATED SHAREHOLDER MATTERS
AND ISSUER PURCHASES OF EQUITY SECURITIES
High
Low
$
9.49
$
5.27
61
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Total Number of Shares
Maximum Number of Shares
Total Number of
Average Price
Purchased as Part of Publicly
that May Yet Be Purchased
Period
Shares Purchased
Paid per Share
Announced Plans or Program
Under the Plans or Programs
2,134
(1)
$
7.03
(1)
NA
NA
0
0
NA
NA
0
0
NA
NA
(1)
Represents shares of common stock surrendered to us as payment
for the exercise price of option awards. The average price paid
per share is the closing price of our common stock on the date
these shares of common stock were surrendered.
62
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Period
from June
16, 1994
(Inception)
to
Year Ended December 31,
December 31,
2009
2008
2007
2006
2005
2009
(in thousands, except share data)
$
1,444
$
1,170
$
1,923
$
200
$
$
4,837
16,929
17,850
15,922
9,637
5,803
79,163
10,891
10,981
5,273
7,845
10,398
3,625
1,904
37,756
22,202
25,695
26,320
24,153
7,707
127,810
(20,758
)
(24,525
)
(24,397
)
(23,953
)
(7,707
)
(122,973
)
214
661
1,582
1,088
333
5,377
(2,202
)
(335
)
(151
)
(91
)
(2,831
)
1,657
372
(125
)
179
8
(2,091
)
$
(21,089
)
$
(23,827
)
$
(23,091
)
$
(22,777
)
$
(7,366
)
$
(118,336
)
$
(2.92
)
$
(8.26
)
$
(10.65
)
$
(12.08
)
$
(4.16
)
7,218,915
2,883,522
2,167,500
1,884,925
1,769,830
As of December 31,
2009
2008
2007
2006
2005
60,305
19,982
24,082
35,885
12,372
49,574
(3,083
)
16,526
32,277
10,672
62,062
21,681
27,162
38,432
13,109
12,758
16,674
1,010
2,015
0
1,780
1,562
1,037
483
89,168
89,168
85,742
40,888
(118,336
)
(97,247
)
(73,420
)
(50,329
)
(27,553
)
43,145
(91,166
)
(69,941
)
(53,363
)
(29,743
)
63
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ITEM 7.
MANAGEMENTS
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
64
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employee and consultant-related expenses, which include salaries
and benefits;
external research and development expenses incurred pursuant to
agreements with third-party manufacturing organizations,
contract research organizations and clinical trial sites;
facilities, depreciation and other allocated expenses, which
include direct and allocated expenses for rent and maintenance
of facilities and depreciation of leasehold improvements and
equipment; and
third-party supplier expenses including laboratory and other
supplies.
65
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Years Ended December 31,
2009
2008
2007
(in thousands)
$
3,666
$
3,521
$
2,944
2,270
3,525
3,630
3,043
2,080
1,943
1,106
1,049
633
502
590
280
10,587
10,765
9,430
2,506
2,572
2,315
1,974
2,774
2,566
1,485
1,346
1,412
377
393
199
6,342
7,085
6,492
$
16,929
$
17,850
$
15,922
66
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revenue recognition;
research and development expenses, primarily clinical trial
expenses;
stock-based compensation;
preferred stock warrant liability; and
fair value measurement of financial instruments.
67
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December 31,
2009
2008
2007
71%-78%
60%
60%
6.08
6.08
6.00-6.08
2.13%-2.72%
2.8%-3.40%
3.78%-4.78%
0%
0%
0%
68
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69
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70
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71
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72
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the progress and results of our clinical trials for OMS103HP,
OMS302 and OMS201;
costs related to manufacturing services;
whether the hiring of a number of new employees to support our
continued growth during this period will occur at salary levels
consistent with our estimates;
the scope, rate of progress, results and costs of our
preclinical testing, clinical trials and other research and
development activities for additional product candidates;
the terms and timing of payments of any collaborative or
licensing agreements that we have or may establish, including
pursuant to our agreements with Asubio Pharma and North Coast
Biologics;
market acceptance of our approved products;
the cost, timing and outcomes of the regulatory processes for
our product candidates;
the costs of commercialization activities, including product
manufacturing, marketing, sales and distribution;
the number and characteristics of product candidates that we
pursue;
the cost of establishing clinical and commercial supplies of our
product candidates;
the cost of preparing, filing, prosecuting, defending and
enforcing patent claims and other intellectual property rights;
the extent to which we acquire or invest in businesses, products
or technologies, although we currently have no commitments or
agreements relating to any of these types of transactions other
than our right to acquire assets for our GPCR program from
Patobios Limited for $10.8 million CAD in cash and stock;
whether we receive grant funding for our programs; and
our degree of success in commercializing OMS103HP and other
product candidates.
73
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Payments Due Within
More than
1 Year
2-3 Years
4-5 Years
5 Years
Total
(in thousands)
$
1,563
$
1,157
$
15
$
$
2,735
5
10
10
40
65
6,408
8,588
14,996
$
7,976
$
9,755
$
25
$
40
$
17,796
(1)
We are contracted to receive sublease income of
$1.6 million, $1.1 million, $23,000, and $15,000 in
2010, 2011, 2012 and 2013, respectively, which is excluded from
operating lease payment amounts.
Pursuant to our agreement with SMRI, beginning the first
calendar year after commencement of commercial sales of a
product candidate from our PDE10 program, we will be obligated
to pay royalties to SMRI based on net income, as defined in the
agreement, not to exceed a set multiple of total grant funding
received. Based on the amount of grant funding that we have
received as of December 31, 2009, the maximum amount of
royalties payable to SMRI is $12.8 million.
Under our antibody discovery and development agreement with
North Coast Biologics, LLC, we may be required to pay a low
single-digit percentage royalty on any net sales of a product
containing an antibody developed by North Coast under the
agreement. Upon the achievement of certain development events,
such as the filing of an IND, initiation of clinical trials and
the receipt of marketing approval, we also may be required to
make additional milestone payments to North Coast of up to
$4.0 million for a MASP-2 antibody and $4.1 million
per additional target antibody that we may select under the
agreement.
Pursuant to our patent assignment agreement with Roberto
Ciccocioppo, Ph.D. under which we acquired assets for our
Addiction program, we may be required to pay a low single-digit
percentage royalty on any net sales of a product from our
Addiction program that is covered by any patents that issue from
the patent application we acquired from Dr. Ciccocioppo. In
addition, if we grant any third parties rights to manufacture,
sell or distribute any such products, we must pay to
Dr. Ciccocioppo a percentage of any associated fees we
receive from such third parties in the range of low
single-digits to low double-digits depending on stage of
development at which such rights are granted. We also may be
required to make milestone payments of up to $2.3 million
upon the achievement of certain development events, such as the
initiation of clinical trials and receipt of marketing approval.
Under our PDE7 inhibitor license agreement with Asubio Pharma
Co., Ltd., we have agreed to make milestone payments to Asubio
of up to $23.5 million upon the achievement of certain
events, such as successful completion of preclinical toxicology
studies; dosing of human subjects in Phase 1, 2 and 3 clinical
trials; receipt of marketing approval of a PDE7 inhibitor
product; and reaching specified sales milestones. In addition,
Asubio is entitled to receive from us a low single-digit
percentage
74
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royalty of any net sales of a PDE7 inhibitor licensed under the
agreement by us
and/or
our
sublicensee(s), provided that if the sales are made by a
sublicensee, then the amount payable by us to Asubio is capped
at an amount equal to a low double-digit percentage of all
royalty and specified milestone payments received by us from the
sublicensee.
75
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ITEM 9.
CHANGES
IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND
FINANCIAL DISCLOSURE
76
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ITEM 12.
SECURITY
OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND
RELATED SHAREHOLDER MATTERS
77
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Number of Securities
Number of Securities to be
Weighted-average
Remaining Available for
Issued Upon Exercise of
Exercise Price of
Future Issuance Under
Outstanding Options,
Outstanding Options,
Equity Compensation
Warrants and Rights
Warrants and Rights
Plans
201,129
$
10.85
1,013,256
2,613,438
$
1.27
0
2,981
$
10.63
0
1,542
$
0.52
0
28,459
$
0.52
0
2,847,549
$
1.94
1,013,256
(1)
Upon adoption of the 2008 Equity Incentive Plan, we reserved a
total of 892,857 shares of our common stock for issuance
thereunder plus any shares returned to the Second Amended and
Restated 1998 Stock Option Plan as a result of termination of
options or repurchase of shares issued pursuant to such plan,
with the maximum number of shares returned equal to
3,084,848 shares. In addition, our 2008 Equity Incentive
Plan provides for annual increases in the number of shares
available for issuance thereunder on the first day of each
fiscal year equal to the least of: (1) five percent of the
outstanding shares of our common stock on the last day of the
immediately preceding fiscal year;
(2) 1,785,714 shares; and (3) such other amount
as our board of directors may determine. On January 1,
2010, an additional 1,064,279 shares became available for
future issuance under out 2008 Equity Incentive Plan in
accordance with the annual increase. These additional shares
from the annual increase are not included in the table above.
(2)
On December 11, 2001 we granted individual option awards to
two of our founders to purchase shares of our common stock.
These option awards were fully vested upon grant and are
exercisable until December 11, 2011.
ITEM 13.
CERTAIN
RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR
INDEPENDENCE
78
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79
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OMEROS CORPORATION
President, Chief Executive Officer
and Chairman of the Board of Directors
President, Chief Executive Officer and Chairman of the Board of
Directors (Principal Executive Officer,
Principal Accounting Officer and
Principal Financial Officer)
March 31, 2010
Director
March 31, 2010
Director
March 31, 2010
Director
March 31, 2010
Director
March 31, 2010
Director
March 31, 2010
Director
March 31, 2010
80
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Page
F-2
F-3
F-4
F-5
F-10
F-11
F-1
Table of Contents
F-2
Table of Contents
(A Development Stage Company)
CONSOLIDATED BALANCE SHEETS
(In thousands except share and per share data)
December 31,
2009
2008
$
820
$
12,726
59,485
7,256
248
207
111
289
60,664
20,478
1,086
918
60
193
193
119
32
$
62,062
$
21,681
$
2,620
$
1,229
2,837
3,764
1,780
702
232
4,931
16,556
11,090
23,561
7,827
118
89,168
213
30
161,227
6,150
41
(99
)
(118,336
)
(97,247
)
43,145
(91,166
)
$
62,062
$
21,681
F-3
Table of Contents
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF
OPERATIONS
(In thousands, except share and per share data)
Period from
June 16,
1994
(Inception)
through
Year Ended December 31,
December 31,
2009
2008
2007
2009
$
1,444
$
1,170
$
1,923
$
4,837
16,929
17,850
15,922
79,163
10,891
5,273
7,845
10,398
37,756
22,202
25,695
26,320
127,810
(20,758
)
(24,525
)
(24,397
)
(122,973
)
214
661
1,582
5,377
(2,202
)
(335
)
(151
)
(2,831
)
1,657
372
(125
)
2,091
$
(21,089
)
$
(23,827
)
$
(23,091
)
$
(118,336
)
$
(2.92
)
$
(8.26
)
$
(10.65
)
7,218,915
2,883,522
2,167,500
F-4
Table of Contents
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF
CONVERTIBLE PREFERRED STOCK AND
SHAREHOLDERS EQUITY (DEFICIT)
(In thousands, except share and per share data)
Deficit
Accumulated
Notes
Accumulated
Convertible
Additional
Other
Deferred
Receivable
During the
Total
Preferred Stock
Common Stock
Paid-in
Comprehensive
Stock-Based
from Related
Development
Shareholders
Shares
Amount
Shares
Amount
Capital
Income (Loss)
Compensation
Party
Stage
Deficit
$
$
$
$
$
$
$
$
1,785,725
18
17
35
446,446
875
(7
)
(7
)
(140
)
(140
)
446,446
875
1,785,725
18
10
(140
)
(112
)
(327
)
(327
)
446,446
875
1,785,725
18
10
(467
)
(439
)
(495
)
(495
)
446,446
875
1,785,725
18
10
(962
)
(934
)
(787
)
(787
)
446,446
875
1,785,725
18
10
(1,749
)
(1,721
)
1,358,840
4,661
(302
)
(302
)
6
6
(22
)
(22
)
(930
)
(930
)
(952
)
1,805,286
5,536
1,785,725
18
(286
)
(22
)
(2,679
)
(2,969
)
(189,733
)
(2
)
(63
)
(65
)
613
8,948
3
3
4
4
3
3
(1,801
)
(1,801
)
(1,798
)
1,805,286
$
5,536
1,605,553
$
16
$
(342
)
$
(19
)
$
$
$
(4,480
)
$
(4,825
)
F-5
Table of Contents
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED
STOCK AND
SHAREHOLDERS EQUITY (DEFICIT) Continued
(In thousands, except share and per share data)
Deficit
Accumulated
Notes
Accumulated
Convertible
Additional
Other
Deferred
Receivable
During the
Total
Preferred Stock
Common Stock
Paid-in
Comprehensive
Stock-Based
from Related
Development
Shareholders
Shares
Amount
Shares
Amount
Capital
Income (Loss)
Compensation
Party
Stage
Deficit
1,805,286
$
5,536
1,605,553
$
16
$
(342
)
$
(19
)
$
$
$
(4,480
)
$
(4,825
)
1,441,539
7,487
(262
)
(262
)
12
4,813
25
25,827
10
10
4,728
2
2
8
8
18
18
(1,363
)
(1,363
)
(1,345
)
3,251,638
13,060
1,636,108
16
(584
)
(1
)
(5,843
)
(6,412
)
24,554
1
8
9
6,260
3
3
20
20
33
33
(2,554
)
(2,554
)
(2,521
)
3,251,638
13,060
1,666,922
17
(553
)
32
(8,397
)
(8,901
)
496,258
3,861
(124
)
(124
)
216,157
2
86
88
9
(9
)
2
2
121
(65
)
56
16
16
(3,152
)
(3,152
)
(3,136
)
3,747,896
$
16,921
1,883,079
$
19
$
(461
)
$
48
$
(7
)
$
(65
)
$
(11,549
)
$
(12,015
)
F-6
Table of Contents
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED
STOCK AND
SHAREHOLDERS EQUITY (DEFICIT) Continued
(In thousands, except share and per share data)
Deficit
Accumulated
Notes
Accumulated
Convertible
Additional
Other
Deferred
Receivable
During the
Total
Preferred Stock
Common Stock
Paid-in
Comprehensive
Stock-Based
from Related
Development
Shareholders
Shares
Amount
Shares
Amount
Capital
Income (Loss)
Compensation
Party
Stage
Deficit
3,747,896
$
16,921
1,883,079
$
19
$
(461
)
$
48
$
(7
)
$
(65
)
$
(11,549
)
$
(12,015
)
6,038
21
(51,021
)
(100
)
178,096
2
93
95
4
4
406
(9
)
(86
)
311
(37
)
(37
)
(4,060
)
(4,060
)
(4,097
)
3,702,913
16,842
2,061,175
21
38
11
(12
)
(151
)
(15,609
)
(15,702
)
1,873,764
18,361
(1,119
)
(1,119
)
28,413
10
11
77
(77
)
263
10
273
1
1
(4,578
)
(4,578
)
(4,577
)
5,576,677
$
35,203
2,089,588
$
21
$
(731
)
$
12
$
(79
)
$
(151
)
$
(20,187
)
$
(21,114
)
F-7
Table of Contents
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED
STOCK AND
SHAREHOLDERS EQUITY (DEFICIT) Continued
(In thousands, except share and per share data)
Deficit
Accumulated
Notes
Accumulated
Convertible
Additional
Other
Deferred
Receivable
During the
Total
Preferred Stock
Common Stock
Paid-in
Comprehensive
Stock-Based
from Related
Development
Shareholders
Shares
Amount
Shares
Amount
Capital
Income (Loss)
Compensation
Party
Stage
Deficit
5,576,677
$
35,203
2,089,588
$
21
$
(731
)
$
12
$
(79
)
$
(151
)
$
(20,187
)
$
(21,114
)
571,581
5,601
(278
)
(278
)
197,503
2
104
106
16,329
84
23
23
(530
)
(88
)
(618
)
(490
)
(490
)
(6
)
(6
)
(7,366
)
(7,366
)
(7,372
)
6,164,587
40,888
2,287,091
23
(1,925
)
6
(56
)
(239
)
(27,553
)
(29,743
)
3,141,304
30,784
(1,821
)
(1,821
)
(607
)
(607
)
1,733,914
14,070
18,498
1
231,493
2
123
126
23
23
1,416
1,416
20
20
(22,777
)
(22,777
)
(22,757
)
11,039,805
85,742
2,537,082
26
(2,814
)
26
(33
)
(239
)
(50,329
)
(53,363
)
12,445
96
339,807
3,330
(90
)
(90
)
(22
)
(22
)
54,666
1
186
187
208,611
2
171
173
81,156
1
154
155
(1
)
(154
)
(155
)
(4
)
21
17
336
6,039
6,039
239
239
(30
)
(30
)
(23,091
)
(23,091
)
(23,121
)
11,392,057
$
89,168
2,881,851
$
29
$
3,466
$
(4
)
$
(12
)
$
$
(73,420
)
$
(69,941
)
F-8
Table of Contents
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED
STOCK AND
SHAREHOLDERS EQUITY (DEFICIT) Continued
(In thousands, except share and per share data)
Deficit
Accumulated
Accumulated
Convertible
Additional
Other
Deferred
During the
Total
Preferred Stock
Common Stock
Paid-in
Comprehensive
Stock-Based
Development
Shareholders
Shares
Amount
Shares
Amount
Capital
Income (Loss)
Compensation
Stage
Deficit
11,392,057
$
89,168
2,881,851
$
29
$
3,466
$
(4
)
$
(12
)
$
(73,420
)
$
(69,941
)
69,555
1
39
40
241
241
101
101
2,303
2,303
12
12
(95
)
(95
)
(23,827
)
(23,827
)
(23,922
)
11,392,057
89,168
2,951,406
30
6,150
(99
)
(97,247
)
(91,166
)
122,451
1,851
6,820,000
68
61,744
61,812
(11,514,508
)
(91,019
)
11,514,508
115
90,904
91,019
902
902
25,633
28
28
5
5
(25,970
)
1,494
1,494
140
140
(21,089
)
(21,089
)
(20,949
)
$
21,285,577
$
213
$
161,227
$
41
$
$
(118,336
)
$
43,145
F-9
Table of Contents
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF CASH
FLOWS
(In thousands)
Period from
June 16,
1994
(Inception)
through
Year Ended December 31,
December 31,
2009
2008
2007
2009
$
(21,089
)
$
(23,827
)
$
(23,091
)
$
(118,336
)
451
434
375
2,002
1,494
2,315
6,056
11,652
(848
)
218
503
(253
)
253
55
308
34
76
(145
)
79
1,948
1,948
10,891
163
(41
)
(17
)
1,110
1,052
42
19
(22
)
(130
)
(486
)
(1,462
)
(1,948
)
207
(140
)
3,162
4,865
470
(268
)
(800
)
(598
)
(19,027
)
(19,673
)
(14,314
)
(88,305
)
(279
)
(164
)
(534
)
(2,072
)
(64,207
)
(30,562
)
(148,104
)
11,045
5,572
11,450
43,716
1,039
5,158
13,555
44,703
(212
)
(52,402
)
10,566
(6,091
)
(61,969
)
61,812
61,812
16,878
16,928
(4,120
)
(1,010
)
(1,005
)
(6,576
)
28
40
360
670
239
239
1,851
3,336
78,234
(48
)
(213
)
59,523
15,908
2,930
151,094
(11,906
)
6,801
(17,475
)
820
12,726
5,925
23,400
$
820
$
12,726
$
5,925
$
820
$
1,947
$
222
$
151
$
2,463
$
280
$
52
$
$
332
$
$
193
$
$
193
$
5
$
101
$
$
106
$
$
241
$
$
241
$
$
$
$
239
$
$
$
$
14,070
F-10
Table of Contents
Note 1
Organization
and Significant Accounting Policies
F-11
Table of Contents
(A Development Stage Company)
NOTES TO THE CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
F-12
Table of Contents
(A Development Stage Company)
NOTES TO THE CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
F-13
Table of Contents
(A Development Stage Company)
NOTES TO THE CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Year Ended December 31,
2009
2008
2007
(in thousands)
$
(21,089
)
$
(23,827
)
$
(23,091
)
140
(95
)
(30
)
$
(20,949
)
$
(23,922
)
$
(23,121
)
F-14
Table of Contents
(A Development Stage Company)
NOTES TO THE CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Note 2
Net Loss
Per Common Share
F-15
Table of Contents
(A Development Stage Company)
NOTES TO THE CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Year Ended December 31,
2009
2008
2007
$
(21,089
)
$
(23,827
)
$
(23,091
)
7,233,109
2,937,789
2,684,162
(14,194
)
(54,267
)
(43,228
)
(473,434
)
7,218,915
2,883,522
2,167,500
$
(2.92
)
$
(8.26
)
$
(10.65
)
December 31,
2009
2008
2007
11,392,057
11,392,057
2,847,549
2,839,851
3,014,309
473,434
209,017
234,230
209,017
28,762
80,882
3,056,566
14,494,900
15,169,699
F-16
Table of Contents
(A Development Stage Company)
NOTES TO THE CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Note 3
Cash,
Cash Equivalents and Investments
December 31, 2009
Gross
Gross
Amortized
Unrealized
Unrealized
Cost
Gains
Losses
Fair Value
(in thousands)
$
1,013
$
$
$
1,013
56,506
56,506
2,938
41
2,979
$
60,457
$
41
$
$
60,498
$
820
193
59,485
$
60,498
December 31, 2008
Gross
Gross
Amortized
Unrealized
Unrealized
Cost
Gains
Losses
Fair Value
(in thousands)
$
12,919
$
$
$
12,919
7,355
3
(102
)
7,256
$
20,274
$
3
$
(102
)
$
20,175
$
12,726
193
7,256
$
20,175
December 31, 2009
Less than 12 Months
12 Months or Greater
Total
Unrealized
Unrealized
Unrealized
Fair Value
Losses
Fair Value
Losses
Fair Value
Losses
(in thousands)
$
116
$
$
26
$
$
142
$
F-17
Table of Contents
(A Development Stage Company)
NOTES TO THE CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
December 31, 2008
Less than 12 Months
12 Months or Greater
Total
Unrealized
Unrealized
Unrealized
Fair Value
Losses
Fair Value
Losses
Fair Value
Losses
(in thousands)
$
4,512
$
(59
)
$
2,123
$
(43
)
$
6,635
$
(102
)
Year Ended December 31,
2009
2008
2007
(in thousands)
$
249
$
737
$
1,437
7
16
310
(42
)
(92
)
(165
)
$
214
$
661
$
1,582
Table of Contents
(A Development Stage Company)
NOTES TO THE CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Note 4
Fair
Value Measurements
December 31, 2009
Level 1
Level 2
Level 3
Total
(in thousands)
$
57,073
$
$
$
57,073
2,979
2,979
$
57,073
$
2,979
$
$
60,052
December 31, 2008
Level 1
Level 2
Level 3
Total
(in thousands)
$
12,783
$
$
$
12,783
7,256
7,256
$
12,783
$
7,256
$
$
20,039
$
$
$
1,780
$
1,780
310
310
$
$
$
2,090
$
2,090
F-19
Table of Contents
(A Development Stage Company)
NOTES TO THE CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Preferred Stock
Notes Payable
Warrant
Success Fee
Liability
Liability
(in thousands)
$
1,780
$
310
(878
)
30
$
(340
)
(902
)
$
$
Note 5
Certain
Balance Sheet Accounts
December 31,
2009
2008
(in thousands)
$
143
$
180
105
27
$
248
$
207
December 31,
2009
2008
(in thousands)
$
279
$
266
379
319
284
284
278
278
1,503
1,016
2,723
2,163
(1,637
)
(1,245
)
$
1,086
$
918
F-20
Table of Contents
(A Development Stage Company)
NOTES TO THE CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
December 31,
2009
2008
(in thousands)
$
1,868
$
1,644
324
319
60
423
310
345
585
723
$
2,837
$
3,764
Note 6
Notes
Payable
F-21
Table of Contents
(A Development Stage Company)
NOTES TO THE CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
F-22
Table of Contents
(A Development Stage Company)
NOTES TO THE CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Loan and
Software
Security
Financing
Agreement
Arrangement
Total
5,029
78
5,107
6,182
54
6,236
1,730
1,730
12,941
132
13,073
(5,029
)
(78
)
(5,107
)
$
7,912
$
54
$
7,966
Note 7
Revenue
F-23
Table of Contents
(A Development Stage Company)
NOTES TO THE CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Note 8
Acquisition
of nura
$
87
233
5,200
182
(2,535
)
3,167
310
10,891
$
14,368
F-24
Table of Contents
(A Development Stage Company)
NOTES TO THE CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Note 9
Commitments
and Contingencies
Lease
Sublease
Net Lease
Payments
Income
Payments
(in thousands)
1,563
554
1,009
1,134
1
1,133
23
23
15
15
$
2,735
$
555
$
3,452
F-25
Table of Contents
(A Development Stage Company)
NOTES TO THE CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
F-26
Table of Contents
(A Development Stage Company)
NOTES TO THE CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Note 10
Warrants
F-27
Table of Contents
(A Development Stage Company)
NOTES TO THE CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
December 31, 2009
December 31, 2008
Weighted-
Weighted-
Warrants
Fair
Average
Warrants
Fair
Average
Outstanding
Value
Exercise Price
Outstanding
Value
Exercise Price
209,017
$
$
12.08
25,246
$
$
13.47
208,983
1,780
12.08
209,017
$
$
12.08
234,229
$
1,780
$
12.23
December 31,
2008
2.3
%
3.25-5.00
71
%
Note 11
Shareholders Equity
F-28
Table of Contents
(A Development Stage Company)
NOTES TO THE CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
December 31,
2009
2008
201,129
25,611
1,013,256
1,020,728
2,613,438
2,781,152
30,001
30,001
2,981
3,086
11,392,057
208,983
209,017
25,247
4,069,822
15,486,865
F-29
Table of Contents
(A Development Stage Company)
NOTES TO THE CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Note 12
Stock-Based
Compensation
five percent of the outstanding shares of the Companys
common stock on the last day of the immediately preceding fiscal
year;
1,785,714 shares; or
such other amount as the Companys board of directors may
determine.
F-30
Table of Contents
(A Development Stage Company)
NOTES TO THE CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Weighted-
Average
Aggregate
Shares
Exercise
Remaining
Intrinsic
Available for
Options
Price per
Contractual Life
Value
Grant
Outstanding
Share
(in years)
(in thousands)
1,020,728
2,839,850
$
1.40
168,049
(166,020
)
1.75
25,968
1.86
(177,496
)
177,496
10.59
(27,767
)
1.53
142,030
(142,030
)
1.90
1,013,259
2,847,549
$
1.94
6.83
$
15,276
2,785,595
$
1.82
6.79
$
15,173
2,391,784
$
1.19
6.53
$
14,019
December 31, 2009
Options Outstanding
Weighted-
Average
Options Exercisable
Remaining
Weighted-
Weighted-
Number of
Contractual
Average
Number of
Average
Options
Life (Years)
Exercise Price
Options
Exercise Price
73,111
1.43
$
0.50
73,111
$
0.50
2,076,224
6.58
0.98
2,018,444
0.98
481,349
7.62
2.33
286,539
2.31
216,865
9.24
10.79
13,690
12.32
2,847,549
6.83
$
1.94
2,391,784
$
1.19
December 31,
2009
2008
2007
71%-78%
60%
60%
6.08
6.08
6.00-6.08
2.13%-2.72%
2.8%-3.40%
3.78%-4.78%
0%
0%
0%
F-31
Table of Contents
(A Development Stage Company)
NOTES TO THE CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Year Ended December 31,
2009
2008
2007
(in thousands)
$879
$983
$482
615
1,332
5,574
$ 1,494
$ 2,315
$ 6,056
Note 13
Income
Taxes
F-32
Table of Contents
(A Development Stage Company)
NOTES TO THE CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
December 31,
2009
2008
(in thousands)
$
30,925
$
24,658
239
79
130
120
2,634
2,281
117
133
34,045
27,271
(34,045)
(27,271)
$
$
December 31,
2009
2008
2007
(in thousands)
(34)
%
(34)
%
(34)
%
4
6
9
20
21
20
10
7
5
F-33
Table of Contents
(A Development Stage Company)
NOTES TO THE CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Note 14
Related-Party
Transactions
Note 15
401(k)
Retirement Plan
F-34
Table of Contents
(A Development Stage Company)
NOTES TO THE CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Note 16
Quarterly
Information (Unaudited)
March 31,
June 30,
September 30,
December 31,
2009
$
197
$
371
$
442
$
434
5,432
6,052
4,969
5,749
(5,235
)
(5,681
)
(4,527
)
(5,315
)
(5,482
)
(6,109
)
(3,916
)
(5,582
)
$
(1.87
)
$
(2.09
)
$
(1.34
)
$
(0.28
)
2008
$
234
$
254
$
501
$
181
5,766
5,151
8,165
6,613
(5,532
)
(4,897
)
(7,664
)
(6,432
)
(5,103
)
(4,961
)
(7,380
)
(6,383
)
$
(1.81
)
$
(1.72
)
$
(2.54
)
$
(2.19
)
F-35
Table of Contents
Exhibit
Footnote
Description
2
.1
(1)
Agreement and Plan of Reorganization among the registrant,
Epsilon Acquisition Corporation, nura, inc. and ARCH Venture
Corporation dated August 4, 2006
3
.1
Amended and Restated Articles of Incorporation of Omeros
Corporation
3
.2
Amended and Restated Bylaws of Omeros Corporation
4
.1
(2)
Form of Omeros Corporation common stock certificate
4
.2
(1)
Stock Purchase Warrant issued by nura, inc. to Oxford Finance
Corporation dated April 26, 2005 (assumed by Omeros
Corporation on August 11, 2006)
4
.3
(1)
Amended and Restated Investors Rights Agreement among
Omeros Corporation and holders of capital stock dated
October 15, 2004
4
.4
(3)
Form of Omeros Corporation Stock Purchase Warrant (as of
December 31, 2009, warrants in this form permitted the
purchase up to a total of 167,885 shares of common stock)
4
.5
(3)
Form of Omeros Corporation Stock Purchase Warrant (as of
December 31, 2009, warrants in this form permitted the
purchase up to a total of 29,593 shares of common stock)
4
.6
(3)
Form of Notice of Waiver of Warrant Termination (applicable to
Stock Purchase Warrants filed as Exhibits 4.4 and 4.5)
10
.1
(1)
*
Form of Indemnification Agreement entered into between Omeros
Corporation and its directors and officers
10
.2
(1)
*
Second Amended and Restated 1998 Stock Option Plan
10
.3
(1)
*
Form of Stock Option Agreement under the Second Amended and
Restated 1998 Stock Option Plan (that does not permit early
exercise)
10
.4
(1)
*
Form of Amendment to Stock Option Agreement under the Second
Amended and Restated 1998 Stock Option Plan (to permit early
exercise)
10
.5
(1)
*
Form of Stock Option Agreement under the Second Amended and
Restated 1998 Stock Option Plan (that permits early exercise)
10
.6
(1)
*
nura, inc. 2003 Stock Plan
10
.7
(1)
*
Form of Stock Option Agreement under the nura, inc. 2003 Stock
Plan
10
.8
(4)
*
2008 Equity Incentive Plan
10
.9
(4)
*
Form of Stock Option Award Agreement under the 2008 Equity
Incentive Plan (used for option awards granted after
October 7, 2009)
10
.10
(4)
*
Form of Stock Option Award Agreement under the 2008 Equity
Incentive Plan (used for option awards granted on or before
October 7, 2009 )
10
.11
(1)
*
Second Amended and Restated Employment Agreement between Omeros
Corporation and Gregory A. Demopulos, M.D. dated
December 30, 2007
10
.12
(1)
*
Non-Plan Stock Option Agreement between Omeros Corporation and
Gregory A. Demopulos, M.D. dated December 11, 2001
10
.13
(1)
*
Offer Letter between Omeros Corporation and Marcia S.
Kelbon, Esq. dated August 16, 2001
10
.14
(1)
*
Offer Letter between Omeros Corporation and Richard J. Klein
dated May 11, 2007
10
.15
(1)
*
Technology Transfer Agreement between Omeros Corporation and
Gregory A. Demopulos, M.D. dated June 16, 1994
10
.16
(1)
Technology Transfer Agreement between Omeros Corporation and
Pamela Pierce, M.D., Ph.D. dated June 16, 1994
10
.17
(1)
*
Second Technology Transfer Agreement between Omeros Corporation
and Gregory A. Demopulos, M.D. dated December 11, 2001
10
.18
(1)
Second Technology Transfer Agreement between Omeros Corporation
and Pamela Pierce, M.D., Ph.D. dated March 22,
2002
10
.19
(1)
*
Technology Transfer Agreement between Omeros Corporation and
Gregory A. Demopulos, M.D. dated June 16, 1994
(related to tendon splice technology)
10
.20
(1)
U.S. Bank Centre Office Lease Agreement between Bentall City
Centre LLC and Scope International, Inc. dated
September 28, 1998
Table of Contents
10
.21
(1)
Assignment and Amendment of Lease among Omeros Corporation, City
Centre Associates and Navigant Consulting, Inc. dated
August 1, 2002
10
.22
(1)
Second Amendment to Office Lease Agreement between Omeros
Corporation and City Centre Associates dated January 4, 2006
10
.23
(1)
Lease Agreement between Alexandria Real Estate Equities, Inc.
and Primal, Inc. dated April 6, 2000
10
.24
(1)
Lease Agreement between Alexandria Real Estate Equities, Inc.
and Primal, Inc. dated September 28, 2001
10
.25
(1)
Assignment and Assumption and Modification of Lease Documents
among Alexandria Real Estate Equities, Inc., Primal, Inc., and
nura, inc. dated October 23, 2003
10
.26
(1)
Assignment and Assumption and Modification of Lease Documents
among Alexandria Real Estate Equities, Inc., nura, inc., and
Omeros Corporation dated September 26, 2007
10
.27
(3)
Commercial Supply Agreement between Omeros Corporation and
Hospira Worldwide, Inc. dated October 9, 2007
10
.28
(3)
Exclusive License and Sponsored Research Agreement between
Omeros Corporation and the University of Leicester dated
June 10, 2004
10
.29
(1)
Research and Development Agreement First Amendment between
Omeros Corporation and the University of Leicester dated
October 1, 2005
10
.30
(3)
Exclusive License and Sponsored Research Agreement between
Omeros Corporation and the Medical Research Council dated
October 31, 2005
10
.31
(1)
Amendment dated May 8, 2007 to Exclusive License and
Sponsored Research Agreement between Omeros Corporation and the
Medical Research Council dated October 31, 2005
10
.32
(5)
Funding Agreement between Omeros Corporation and The Stanley
Medical Research Institute dated December 18, 2006
10
.33
(5)
Drug Product Development and Clinical Supply Agreement between
Omeros Corporation and Althea Technologies, Inc. dated
January 20, 2006
10
.34
(3)
Project Plan for Non-GMP and cGMP Fill and Finish of OMS302
between Omeros Corporation and Althea Technologies, Inc. dated
May 31, 2007
10
.35
(4)
Landlord Consent to Sublease among Christensen OConnor
Johnson Kindness PLLC, City Centre Associates and Omeros
Corporation dated January 29, 2008
10
.36
(3)
Agreement for Antibody Discovery and Development between Omeros
Corporation and Affitech AS dated July 25, 2008
10
.37
(5)
Exclusive Technology Option Agreement between Omeros
Corporation, Patobios Limited, Susan R. George, M.D., Brian
F. ODowd, Ph.D. and U.S. Bank National Association as
escrow agent dated September 4, 2008
10
.38
(6)
First Amendment of Exclusive Technology Option Agreement between
Omeros Corporation, Patobios Limited, Susan R.
George, M.D., Brian F. ODowd, Ph.D. and U.S.
Bank National Association as escrow agent dated
November 10, 2009
10
.39
(5)
Loan and Security Agreement between Omeros Corporation and
BlueCrest Capital Finance, L.P. dated September 12, 2008
10
.40
(5)
Promissory Note issued by Omeros Corporation to BlueCrest
Capital Finance, L.P. dated September 12, 2008
10
.41
(5)
Promissory Note issued by Omeros Corporation to BlueCrest
Capital Finance, L.P. dated December 23, 2008
10
.42
(3)
Agreement for Antibody Development between Omeros Corporation
and North Coast Biologics LLC dated October 31, 2008
10
.43
(3)
Patent Assignment Agreement between Omeros Corporation and
Roberto Ciccocioppo, Ph.D. dated February 23, 2009
10
.44
(5)
*
Amendment to Exercise Notice and Restricted Stock Purchase
Agreements between the registrant and Richard J. Klein dated
April 29, 2009
10
.45
(3)
*
Second Amendment to Exercise Notice and Restricted Stock
Purchase Agreements between the registrant and Richard J. Klein
dated July 28, 2009.
10
.46
(3)
*
Omeros Corporation Non-Employee Director Compensation Policy.
Table of Contents
21
.1
(1)
List of significant subsidiaries of Omeros Corporation
23
.1
Consent of Independent Registered Public Accounting Firm
31
.1
Certification of Principal Executive Officer Pursuant to
Rule 13-14(a)
or
Rule 15d-14(a)
of the Securities Exchange Act of 1934 as Adopted Pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002
31
.2
Certification of Principal Financial Officer Pursuant to
Rule 13-14(a)
or
Rule 15d-14(a)
of the Securities Exchange Act of 1934 as Adopted Pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002
32
.1
Certification of Principal Executive Officer Pursuant to
18 U.S.C. Section 1350, as Adopted Pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002
32
.2
Certification of Principal Financial Officer Pursuant to
18 U.S.C. Section 1350, as Adopted Pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002
(1)
Incorporated by reference from the Registration Statement on
Form S-1
filed by Omeros Corporation on January 9, 2008 (File
No. 333-148572).
(2)
Incorporated by reference from the Registration Statement on
Form S-1/A
filed by Omeros Corporation on October 2, 2009 (File
No. 333-148572).
(3)
Incorporated by reference from the Registration Statement on
Form S-1/A
filed by Omeros Corporation on September 16, 2009 (File
No. 333-148572).
(4)
Incorporated by reference from the Registration Statement on
Form S-1/A
filed by Omeros Corporation on April 1, 2008 (File
No. 333-148572).
(5)
Incorporated by reference from the Registration Statement on
Form S-1/A
filed by Omeros Corporation on May 15, 2009 (File
No. 333-148572).
(6)
Incorporated by reference from the Current Report on
Form 8-K
filed by Omeros Corporation on November 12, 2009 (File
No. 001-34475).
*
Indicates management contract or compensatory plan or
arrangement.
Portions of this exhibit are redacted in accordance with a grant
of confidential treatment.
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By: | /s/ Gregory A. Demopulos | |||
Gregory A. Demopulos, M.D. | ||||
Chairman of the Board, President and
Chief Executive Officer |
||||
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Page | ||||
ARTICLE I CORPORATE OFFICES
|
1 | |||
|
||||
1.1 REGISTERED OFFICE
|
1 | |||
1.2 OTHER OFFICES
|
1 | |||
|
||||
ARTICLE II MEETINGS OF SHAREHOLDERS
|
1 | |||
|
||||
2.1 ANNUAL MEETINGS
|
1 | |||
2.2 SPECIAL MEETINGS
|
1 | |||
2.3 MEETINGS BY COMMUNICATION EQUIPMENT
|
1 | |||
2.4 DATE, TIME AND PLACE OF MEETINGS
|
1 | |||
2.5 NOTICE OF MEETINGS
|
2 | |||
2.6 BUSINESS FOR SHAREHOLDERS MEETING
|
3 | |||
2.7 WAIVER OF NOTICE
|
4 | |||
2.8 FIXING OF RECORD DATE FOR DETERMINING SHAREHOLDERS
|
4 | |||
2.9 VOTING RECORD
|
5 | |||
2.10 QUORUM
|
5 | |||
2.11 MANNER OF ACTING
|
5 | |||
2.12 PROXIES
|
5 | |||
2.13 VOTING OF SHARES
|
6 | |||
2.14 ACTION BY SHAREHOLDERS WITHOUT A MEETING
|
6 | |||
2.15 INSPECTORS OF ELECTION
|
6 | |||
|
||||
ARTICLE III DIRECTORS
|
7 | |||
|
||||
3.1 POWERS
|
7 | |||
3.2 NUMBER AND TENURE OF DIRECTORS
|
7 | |||
3.3 NOMINATION AND ELECTION
|
7 | |||
3.4 ANNUAL AND REGULAR MEETINGS
|
8 | |||
3.5 SPECIAL MEETINGS
|
8 | |||
3.6 MEETINGS BY COMMUNICATIONS EQUIPMENT
|
8 | |||
3.7 NOTICE OF SPECIAL MEETINGS
|
9 | |||
3.8 WAIVER OF NOTICE
|
10 | |||
3.9 QUORUM
|
10 | |||
3.10 MANNER OF ACTING
|
10 | |||
3.11 PRESUMPTION OF ASSENT
|
10 | |||
3.12 ACTION BY BOARD OR COMMITTEES WITHOUT A MEETING
|
10 | |||
3.13 RESIGNATION
|
11 | |||
3.14 REMOVAL
|
11 | |||
3.15 VACANCIES
|
11 | |||
3.16 COMMITTEES
|
11 | |||
3.17 COMPENSATION
|
12 | |||
|
||||
ARTICLE IV OFFICERS
|
12 | |||
|
||||
4.1 OFFICERS
|
12 |
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Page | ||||
4.2 APPOINTMENT OF OFFICERS
|
13 | |||
4.3 SUBORDINATE OFFICERS
|
13 | |||
4.4 REMOVAL AND RESIGNATION OF OFFICERS
|
13 | |||
4.5 VACANCIES IN OFFICES
|
13 | |||
4.6 REPRESENTATION OF SHARES OF OTHER CORPORATIONS
|
13 | |||
4.7 AUTHORITY AND DUTIES OF OFFICERS
|
13 | |||
|
||||
ARTICLE V SHARES
|
14 | |||
|
||||
5.1 ISSUANCE OF SHARES
|
14 | |||
5.2 CERTIFICATES FOR SHARES
|
14 | |||
5.3 STOCK RECORDS
|
14 | |||
5.4 RESTRICTIONS ON TRANSFER
|
14 | |||
5.5 TRANSFER OF SHARES
|
15 | |||
5.6 LOST OR DESTROYED CERTIFICATES
|
15 | |||
|
||||
ARTICLE VI RECORDS AND REPORTS
|
15 | |||
|
||||
6.1 CORPORATE RECORDS
|
15 | |||
6.2 INSPECTION OF RECORDS BY SHAREHOLDERS
|
16 | |||
|
||||
ARTICLE VII INDEMNIFICATION
|
16 | |||
|
||||
7.1 INDEMNIFICATION OF DIRECTORS AND OFFICERS
|
16 | |||
7.2 INDEMNIFICATION OF OTHERS
|
17 | |||
7.3 ADVANCEMENT OF EXPENSES
|
17 | |||
7.4 RIGHT OF INDEMNITEE TO BRING SUIT
|
17 | |||
7.5 PROCEDURES EXCLUSIVE
|
18 | |||
7.6 NONEXCLUSIVITY OF RIGHTS
|
18 | |||
7.7 INSURANCE, CONTRACTS AND FUNDING
|
18 | |||
7.8 AMENDMENT OR REPEAL
|
18 | |||
|
||||
ARTICLE VIII GENERAL MATTERS
|
18 | |||
|
||||
8.1 EXECUTION OF CORPORATE CONTRACTS AND INSTRUMENTS
|
18 | |||
8.2 FISCAL YEAR
|
18 | |||
8.3 SEAL
|
19 | |||
8.4 CONSTRUCTION; DEFINITIONS
|
19 | |||
|
||||
ARTICLE IX AMENDMENTS
|
19 |
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1. | I have reviewed this annual report on Form 10-K of Omeros Corporation; | ||
2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; | ||
3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; | ||
4. | The registrants other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have: |
a. | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; | ||
b. | Evaluated the effectiveness of the registrants disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and | ||
c. | Disclosed in this report any change in the registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and |
5. | The registrants other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of the registrants board of directors (or persons performing the equivalent functions): |
a. | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrants ability to record, process, summarize, and report financial information; and | ||
b. | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal control over financial reporting. |
/s/ Gregory A. Demopulos, M.D. | ||||
Gregory A. Demopulos, M.D. | ||||
Chairman and Chief Executive Officer |
1. | I have reviewed this annual report on Form 10-K of Omeros Corporation; | ||
2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; | ||
3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; | ||
4. | The registrants other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have: |
a. | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; | ||
b. | Evaluated the effectiveness of the registrants disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and | ||
c. | Disclosed in this report any change in the registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and |
5. | The registrants other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of the registrants board of directors (or persons performing the equivalent functions): |
a. | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrants ability to record, process, summarize, and report financial information; and | ||
b. | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal control over financial reporting. |
/s/ Gregory A. Demopulos | ||||
Gregory A. Demopulos, M.D. | ||||
Principal Financial Officer | ||||
(1) | The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and | ||
(2) | The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
/s/ Gregory A. Demopulos, M.D. | ||||
Gregory A. Demopulos, M.D. | ||||
Chairman and Chief Executive Officer |
(1) | The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and | ||
(2) | The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
/s/ Gregory A. Demopulos | ||||
Gregory A. Demopulos, M.D. | ||||
Principal Financial Officer | ||||