UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 19, 2009
OMEROS CORPORATION
(Exact name of registrant as specified in its charter)
| Washington | 001-34475 | 91-1663741 | ||
| (State or other jurisdiction of | (Commission File Number) | (IRS Employer | ||
| incorporation) | Identification No.) |
1420 Fifth Avenue, Suite 2600
Seattle, Washington 98101
(Address of principal executive offices, including zip code)
Seattle, Washington 98101
(Address of principal executive offices, including zip code)
(206) 676-5000
(Registrant’s telephone number, including area code)
(Former name or former address, if changed since last report)
(Registrant’s telephone number, including area code)
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the
filing obligation of the registrant under any of the following provisions (see General Instruction
A.2. below):
| o | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |
| o | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |
| o | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |
| o | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 2.02 Results of Operation and Financial Condition.
On November 19, 2009, Omeros Corporation issued a press release announcing financial results
for the three and nine months ended September 30, 2009. A copy of such press release is furnished
herewith as Exhibit 99.1 and is incorporated herein by reference.
The information in this Current Report on Form 8-K, including the exhibit hereto, shall not be
deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended,
or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the
Securities Act of 1933, as amended. The information contained herein and in the accompanying
exhibit shall not be incorporated by reference into any filing with the United States Securities
and Exchange Commission made by Omeros, whether made before or after the date hereof, regardless of
any general incorporation language in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit | ||
| Number | Description | |
99.1
|
Press release dated November 19, 2009 relating to Omeros’ financial results for the three and nine months ended September 30, 2009. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| OMEROS CORPORATION |
||||
| By: | /s/ Gregory A. Demopulos | |||
| Gregory A. Demopulos, M.D. | ||||
| President, Chief Executive Officer and Chairman of the Board of Directors |
||||
Date: November 19, 2009
EXHIBIT INDEX
| Exhibit | ||
| Number | Description | |
99.1
|
Press release dated November 19, 2009 relating to Omeros’ financial results for the three and nine months ended September 30, 2009. |
Exhibit 99.1
Omeros Corporation Reports Third Quarter 2009 Financial Results and Development Highlights
Seattle, WA — November 19, 2009 — Omeros Corporation (NASDAQ: OMER) today announced unaudited
financial results for the third quarter ended September 30, 2009. For the three months ended
September 30, 2009, Omeros reported a net loss of $3.9 million, or $1.34 per share, as compared to
a net loss of $7.4 million, or $2.54 per share, for the same period in 2008. For the nine months
ended September 30, 2009, the Company reported a net loss of $15.5 million, or $5.29 per share, as
compared to a net loss of $17.4 million, or $6.07 per share, for the same period in 2008.
On
October 7, 2009, Omeros priced its initial public offering (IPO), which generated net proceeds to the
Company of approximately $61.8 million from the sale of 6,820,000 shares of its common stock at a
price of $10.00 per share.
“Our IPO afforded Omeros the resources to advance aggressively our
pipeline of clinical and preclinical programs. We expect that the proceeds will allow us to
complete our ongoing Phase 3 clinical trials for our lead PharmacoSurgery™ product, OMS103HP, and
fund its commercial launch into the arthroscopy market. We also recently amended a key agreement
for our GPCR program, providing us with additional opportunities to realize the value of the
program while limiting our expenditures,” said Gregory A. Demopulos, M.D., Chairman and CEO of
Omeros. “Throughout the course of next year, we look forward to releasing data from our Phase 3
arthroscopic program as well as meeting additional clinical milestones for our ophthalmologic and
urologic programs.”
Financial Results
Total operating expenses for the three months ended September 30, 2009 were $5.0 million compared
to $8.2 million for the same period in 2008. The decrease in operating expenses in the third
quarter of 2009 as compared to the same period of 2008 was primarily a result of the 2008 write-off
of $1.9 million of deferred offering costs related to a delay in
the Company’s IPO. Also, in the 2009 period there were decreases in contract service costs associated with
several of Omeros’ clinical and preclinical programs and in clinical trial expenses due to the
prior completion of enrollment in the Company’s Phase 2 clinical study of OMS103HP for arthroscopic
meniscectomy surgery.
Total operating expenses for the nine months ended September 30, 2009 were $16.5 million, compared
to $19.1 million for the same period in 2008. The decrease in operating expenses in the
nine months ended September 30, 2009 as compared to the same period of 2008 was primarily a result
of items noted above.
Recent Highlights
| • | Priced the Company’s IPO on October 7, 2009, receiving net proceeds of approximately $61.8 million, and began trading on The NASDAQ Global Market under the ticker symbol “OMER” on October 8, 2009. | ||
| • | Announced positive results from the Phase 1/Phase 2 clinical trial of OMS302, Omeros’ PharmacoSurgery product candidate being developed for use during ophthalmological procedures. OMS302 is a proprietary combination of an anti-inflammatory agent and an agent that causes pupil dilation (mydriasis), each with well-known safety and pharmacologic profiles. |
| The Phase 1/Phase 2 trial enrolled 61 patients undergoing age-related cataract extraction with lens replacement, and was designed to evaluate efficacy and safety of OMS302 added to a standard surgical irrigation solution. Data from this study showed that patients treated with OMS302 reported less postoperative pain and demonstrated statistically significant improvement in maintenance of mydriasis during the surgical procedure compared to patients treated with vehicle control. | |||
| • | Amended its agreement with Patobios Limited by which Omeros has the exclusive right to acquire all intellectual property rights to an assay for use in the Company’s GPCR program. As a result of the amendment, Omeros now has the right to de-orphanize at least three orphan GPCRs using the assay without having to immediately purchase the associated intellectual property from Patobios for the $10.8 million CAD purchase price, and Omeros can also grant to third parties development and/or commercialization rights to those de-orphanized GPCRs. Under the amendment, Omeros will be required to pay Patobios a one-time $500,000 CAD de-orphanization milestone payment instead of the $10.8 million CAD purchase price, with the $500,000 CAD milestone payment credited in full against the purchase price if Omeros acquires the assets. |
Conference Call and Webcast Today at 5:00 p.m. Eastern Time
The Omeros management team will host a conference call today, November 19, at 5:00 p.m. Eastern
Time (2:00 p.m. Pacific Time), to discuss the Company’s third quarter 2009 financial results and
development highlights. Interested parties may participate in the conference call by dialing
877-795-3638 (Domestic) or 719-325-4891 (International). To access the webcast, please go to the
Company’s website at www.omeros.com and go to the “Events” section of the “Investors” page to log
on.
A replay of the webcast will be available on the website for one week following the call. A
telephone replay will also be available from 7:00 p.m. Eastern Time on November 19 through 11:59
p.m. Eastern Time on November 22 by dialing 888-203-1112 (Domestic) or 719-457-0820 (International)
and entering conference ID number 4396920.
About Omeros Corporation
Omeros Corporation is a clinical-stage biopharmaceutical company committed to discovering,
developing and commercializing products focused on inflammation and disorders of the central
nervous system. Omeros’ most clinically advanced product
candidates are derived from its proprietary PharmacoSurgery(TM) platform designed to improve
clinical outcomes of patients undergoing arthroscopic, ophthalmological, urological and other
surgical and medical procedures. Omeros has four ongoing
PharmacoSurgery(TM) clinical development
programs, and its lead product candidate, OMS103HP, is being evaluated in Phase 3 clinical trials
for use during arthroscopic surgery to improve postoperative joint function and reduce
postoperative pain. Omeros is also building a diverse pipeline of preclinical programs targeting
inflammation and central nervous system disorders.
Forward-Looking Statements
This press release contains forward-looking statements as defined within the Private Securities
Litigation Reform Act of 1995, which are subject to the “safe harbor” created by those sections.
These statements include, but are not limited to, statements regarding the Company’s ability to
advance its clinical and preclinical pipeline, including completing its ongoing Phase 3 clinical
trials of OMS103HP and funding the commercial launch of OMS103HP with the proceeds from its initial
public offering; to realize the value of its GPCR program while limiting the Company’s expenditures
as a result of changes to its agreement with Patobios Limited; to release data from its Phase 3
arthroscopic program as well as meet additional clinical milestones for its ophthalmologic and
urologic programs over the course of next year; and to de-orphanize orphan GPCRs and grant related
development and/or commercialization rights to third parties. Forward-looking statements are based
on management’s beliefs and assumptions and on information available to management only as of the
date of this press release. Omeros’ actual results could differ materially from those anticipated
in these forward-looking statements for many reasons, including, without limitation, the risks,
uncertainties and other factors described under the heading “Risk Factors” in the Company’s
Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 19,
2009. Given these risks, uncertainties and other factors, you should not place undue reliance on
these forward-looking statements, and the Company assumes no obligation to update these
forward-looking statements publicly, even if new information becomes available in the future.
Contact:
Carney Noensie
Burns McClellan
Investor & Media Relations
212-213-0006
cnoensie@burnsmc.com
Carney Noensie
Burns McClellan
Investor & Media Relations
212-213-0006
cnoensie@burnsmc.com
OMEROS CORPORATION
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share data)
(unaudited)
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except share and per share data)
(unaudited)
| Period from | ||||||||||||||||||||
| June 16, | ||||||||||||||||||||
| 1994 | ||||||||||||||||||||
| (Inception) | ||||||||||||||||||||
| Three Months Ended | Nine Months Ended | through | ||||||||||||||||||
| September 30, | September 30, | September 30, | ||||||||||||||||||
| 2009 | 2008 | 2009 | 2008 | 2009 | ||||||||||||||||
Grant revenue |
$ | 442 | $ | 501 | $ | 1,010 | $ | 989 | $ | 4,403 | ||||||||||
Operating expenses: |
||||||||||||||||||||
Research and development |
3,692 | 4,737 | 12,291 | 12,755 | 74,525 | |||||||||||||||
Acquired in-process research and development |
— | — | — | — | 10,891 | |||||||||||||||
General and administrative |
1,277 | 3,428 | 4,162 | 6,327 | 36,645 | |||||||||||||||
Total operating expenses |
4,969 | 8,165 | 16,453 | 19,082 | 122,061 | |||||||||||||||
Loss from operations |
(4,527 | ) | (7,664 | ) | (15,443 | ) | (18,093 | ) | (117,658 | ) | ||||||||||
Investment income |
47 | 114 | 189 | 574 | 5,352 | |||||||||||||||
Interest expense |
(540 | ) | (52 | ) | (1,705 | ) | (90 | ) | (2,334 | ) | ||||||||||
Other income (expense) |
1,104 | 222 | 1,452 | 165 | 1,886 | |||||||||||||||
Net loss |
$ | (3,916 | ) | $ | (7,380 | ) | $ | (15,507 | ) | $ | (17,444 | ) | $ | (112,754 | ) | |||||
Basic and diluted net loss per common share |
$ | (1.34 | ) | $ | (2.54 | ) | $ | (5.29 | ) | $ | (6.07 | ) | ||||||||
Weighted-average shares used to compute
basic and diluted net loss per common share |
2,930,391 | 2,909,688 | 2,929,728 | 2,871,704 | ||||||||||||||||
Pro forma basic and diluted net loss per common share
|
$ | (0.33 | ) | $ | (0.52 | ) | $ | (1.14 | ) | $ | (1.21 | ) | ||||||||
Weighted-average pro forma shares used to compute
pro forma basic and diluted net loss per share |
14,444,897 | 14,301,745 | 14,422,465 | 14,263,761 | ||||||||||||||||
OMEROS CORPORATION
(A Development Stage Company)
CONSOLIDATED BALANCE SHEETS
(In thousands)
(A Development Stage Company)
CONSOLIDATED BALANCE SHEETS
(In thousands)
| September 30, | December 31, | |||||||
| 2009 | 2008 | |||||||
| (unaudited) | ||||||||
Assets |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 1,367 | $ | 12,726 | ||||
Short-term investments |
3,125 | 7,256 | ||||||
Grant and other receivables |
320 | 207 | ||||||
Prepaid expenses and other current assets |
128 | 289 | ||||||
Total current assets |
4,940 | 20,478 | ||||||
Deferred offering costs |
1,034 | — | ||||||
Property and equipment, net |
681 | 918 | ||||||
Intangible assets, net |
— | 60 | ||||||
Restricted cash |
193 | 193 | ||||||
Other assets |
62 | 32 | ||||||
Total assets |
$ | 6,910 | $ | 21,681 | ||||
Liabilities, convertible preferred stock and shareholders’ equity (deficit) |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 1,530 | $ | 1,229 | ||||
Accrued expenses |
3,739 | 3,764 | ||||||
Preferred stock warrant liability |
902 | 1,780 | ||||||
Deferred revenue |
1,019 | 232 | ||||||
Current portion of notes payable |
4,750 | 16,556 | ||||||
Total current liabilities |
11,940 | 23,561 | ||||||
Notes payable, less current portion |
9,244 | 118 | ||||||
Commitments and contingencies |
||||||||
Convertible preferred stock: |
||||||||
Issued and outstanding shares—11,514,506 at September 30, 2009 (unaudited) and
11,392,057 at December 31, 2008; |
||||||||
Liquidation preference of $93,284 at September 30, 2009 (unaudited) and $92,084
at December 31, 2008 |
91,019 | 89,168 | ||||||
Shareholders’ equity (deficit): |
||||||||
Preferred stock, par value $0.01 per share: |
||||||||
Authorized shares — 13,425,919 at September 30, 2009 (unaudited) and
December 31, 2008 |
||||||||
Designated convertible — 13,425,919 at September 30, 2009 (unaudited) and
December 31, 2008 |
— | — | ||||||
Common stock, par value $0.01 per share: |
||||||||
Authorized shares — 20,410,000 at September 30, 2009 (unaudited) and
December 31, 2008; |
||||||||
Issued and outstanding shares—2,930,167 and 2,951,406 at September 30, 2009
(unaudited) and December 31, 2008, respectively |
30 | 30 | ||||||
Additional paid-in capital |
7,408 | 6,150 | ||||||
Accumulated other comprehensive loss |
23 | (99 | ) | |||||
Deficit accumulated during the development stage |
(112,754 | ) | (97,247 | ) | ||||
Total shareholders’ deficit |
(105,293 | ) | (91,166 | ) | ||||
Total liabilities, convertible preferred stock, and shareholders’ equity (deficit) |
$ | 6,910 | $ | 21,681 | ||||