UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C.
20549
FORM 8-K
CURRENT
REPORT
Pursuant to Section 13 or 15(d) of
the
Securities Exchange Act of 1934
| Date of Report (Date of earliest event reported): August 4, 2009 |
| REGENERON PHARMACEUTICALS, INC. | ||
| (Exact Name of Registrant as Specified in Charter) |
| New York | 000-19034 | 13-3444607 | ||
| (State or other jurisdiction of | (Commission File No.) | (IRS Employer Identification No.) | ||
| Incorporation) |
| 777 Old Saw Mill River Road, Tarrytown, New York 10591-6707 |
| (Address of principal executive offices, including zip code) |
| (914) 347-7000 |
| (Registrant's telephone number, including area code) |
| 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: | ||
| 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 Operations and Financial Condition.
On August 4, 2009, Regeneron Pharmaceuticals, Inc. issued a press release announcing its financial and operating results for the quarter ended June 30, 2009. The press release is being furnished to the Securities and Exchange Commission pursuant to Item 2.02 of Form 8-K and is attached as Exhibit 99.1 to this Form 8-K.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
99.1 Press Release dated August 4, 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.
| Date: August 4, 2009 | REGENERON PHARMACEUTICALS, INC. | ||
| By: | /s/ Stuart Kolinski | ||
| Name: | Stuart Kolinski | ||
| Title: | Senior Vice President and General Counsel | ||
Exhibit Index
| Number | Description | ||
| 99.1 | Press Release dated August 4, 2009. | ||
 |
Exhibit 99.1 |
For Immediate Release
Press Release
Regeneron Reports Second Quarter 2009 Financial and Operating Results
Tarrytown, New York (August 4, 2009) -- Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) today announced financial and operating results for the second quarter of 2009. The Company reported a net loss of $14.9 million, or $0.19 per share (basic and diluted), for the second quarter of 2009 compared with a net loss of $18.7 million, or $0.24 per share (basic and diluted), for the second quarter of 2008. The Company reported a net loss of $30.3 million, or $0.38 per share (basic and diluted), for the six months ended June 30, 2009 compared with a net loss of $30.5 million, or $0.39 per share (basic and diluted), for the same period in 2008.
At June 30, 2009, cash, restricted cash, and marketable securities totaled $466.4 million compared with $527.5 million at December 31, 2008.
Current Business Highlights
ARCALYST® (rilonacept) – Inflammatory
Diseases
The Company shipped $5.4 million of
ARCALYST® (rilonacept) Injection for
Subcutaneous Use to its U.S. distributors during
the second quarter of 2009, compared to $1.6 million during the same period of
2008. Shipments during the first six months of 2009 were $9.8 million compared
to $2.4 million in the prior year period. ARCALYST, an interleukin-1 (IL-1)
blocker, was approved in February 2008 for the treatment of Cryopyrin-Associated
Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome
(FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 12 and older. The
Company currently projects shipments of ARCALYST to its U.S. distributors to
total approximately $15-20 million in 2009. In July 2009, the Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMEA) issued a positive opinion for the marketing
authorization in the European Union of rilonacept for the treatment of CAPS with
severe symptoms in adults and children aged 12 years and older.
ARCALYST is in a Phase 3 clinical development program for the treatment of gout. The program includes four clinical trials, three of which are currently enrolling patients. Two Phase 3 clinical trials (called PRE-SURGE 1 and PRE-SURGE 2) are evaluating ARCALYST versus placebo for the prevention of gout flares in patients initiating urate-lowering drug therapy. A third Phase 3 trial in acute gout (SURGE) is evaluating treatment with ARCALYST alone versus ARCALYST in combination with a non-steroidal anti-inflammatory drug (NSAID) versus an NSAID alone. The Phase 3 clinical development program also includes a separate placebo-controlled safety study (RESURGE). The Company expects to report initial data from the Phase 3 program in 2010. Regeneron owns worldwide rights to ARCALYST.
Additional data from the previously reported Phase 2 study of ARCALYST for the prevention of gout flares induced by the initiation of urate-lowering drug therapy were presented at the annual meeting of the European League Against Rheumatism (EULAR) in June 2009. Through 16 weeks of treatment, patients treated with ARCALYST® (rilonacept) on average experienced significantly fewer gout flares per patient than did patients treated with placebo. The mean number of flares per patient was 0.93 with placebo and 0.22 with ARCALYST (p=0.0036). These data are consistent with the previously reported results through 12 weeks of treatment, in which the mean number of flares per patient was 0.79 with placebo and 0.15 with ARCALYST (p=0.0011). Adverse events after 16 weeks of treatment were similar to those reported after 12 weeks. Reported adverse events were similar between treatment groups, with the most common categories being infections and musculoskeletal system disorders.
Aflibercept (VEGF Trap) –
Oncology
Aflibercept, an anti-angiogenic
protein product candidate designed to bind all forms of vascular endothelial
growth factor A (VEGF-A), is being developed worldwide by Regeneron and its
collaborator, sanofi-aventis. At the end of the second quarter of 2009, more
than 60 percent of the planned number of patients were enrolled in four Phase 3
trials that are evaluating combinations of aflibercept with standard
chemotherapy regimens for the treatment of cancer. One trial (called
VELOUR) is
evaluating aflibercept as a 2nd line
treatment for metastatic colorectal cancer in combination with FOLFIRI (folinic
acid (leucovorin), 5-fluorouracil, and irinotecan). A second trial (VANILLA) is
evaluating aflibercept as a 1st line
treatment for metastatic pancreatic cancer in combination with gemcitabine. A
third trial (VITAL) is evaluating aflibercept as a 2nd line treatment for metastatic non-small cell lung cancer in
combination with docetaxel. The fourth trial (VENICE) is evaluating aflibercept
as a 1st line treatment for metastatic
androgen-independent prostate cancer in combination with docetaxel/prednisone.
All four trials are studying the current standard of chemotherapy care for the
cancer being studied with and without aflibercept. Initial data from the Phase 3
program are expected in 2010. In addition, a Phase 2 study (AFFIRM) of
aflibercept in 1st line metastatic
colorectal cancer in combination with folinic acid (leucovorin), 5-fluorouracil,
and oxaliplatin began recruiting patients in January 2009.
Results of a Phase 2 single-agent study of aflibercept in advanced ovarian cancer (AOC) patients with symptomatic malignant ascites (SMA) were reported in a press release issued on June 11, 2009. Symptomatic malignant ascites is an abnormal build-up of fluid in the abdominal cavity in patients with advanced cancer. Patients treated with aflibercept experienced a statistically significant improvement in the primary study endpoint, mean time to first repeat paracentesis (removal of fluid from the abdominal cavity), versus placebo control. The types and frequencies of adverse events reported with aflibercept in this study were generally consistent with those reported in clinical studies with other anti-VEGF therapies in advanced ovarian cancer patients. Regeneron and sanofi-aventis decided that because it is difficult, based on this study, to definitively assess the overall clinical benefit that might be derived from treatment in a clinical practice setting, they will not submit these Phase 2 data to regulatory authorities for accelerated approval in symptomatic malignant ascites.
VEGF Trap-Eye – Ophthalmologic
Diseases
VEGF Trap-Eye, a specially purified and
formulated form of VEGF Trap for use in intraocular treatment of retinal
disease, is being developed by Regeneron and its collaborator, Bayer HealthCare.
Full enrollment in the Phase 3 program (consisting of the VIEW 1 and VIEW 2
studies) evaluating VEGF Trap-Eye in patients with the neovascular form of
Age-related Macular Degeneration (wet AMD) is expected later in 2009, and
initial data from this program are expected to be reported in late 2010. A Phase
2 study (called DA VINCI) of VEGF Trap-Eye for the treatment of the Diabetic
Macular Edema (DME) completed enrollment in July 2009, and initial data are
expected during the first half of 2010. Regeneron and Bayer HealthCare also
initiated a Phase 3 program in Central Retinal Vein Occlusion (CRVO) in July
2009. In connection with dosing the first patient in a Phase 3 study in CRVO,
Regeneron received a $20.0 million milestone payment.
Bayer HealthCare has rights to market VEGF Trap-Eye outside the United States, where the companies will share equally in profits from any future sales of VEGF Trap-Eye. Regeneron maintains exclusive rights to VEGF Trap-Eye in the United States.
Monoclonal Antibodies
Phase 1 clinical studies are underway with three human
monoclonal antibodies generated by Regeneron using its VelocImmune® technology.
REGN88 is an antibody to the interleukin-6 receptor (IL-6R) that is being
evaluated in rheumatoid arthritis. REGN475, an antibody to Nerve Growth Factor (NGF)
that binds NGF selectively without cross-reacting with other members of the
neurotrophin family, is being developed for the treatment of pain. REGN421, an
antibody to Delta-like ligand-4 (Dll4), is being studied in patients with
advanced malignancies. These antibodies are being developed within the Company’s
human antibody collaboration with sanofi-aventis. Over the course of the next
several years, the Company and sanofi-aventis plan to advance an average of two
to three new fully human monoclonal antibodies into clinical development each
year.
Other
In June
2009, the Company announced that it had entered into two royalty agreements with
Novartis Pharma AG that replaced a previous collaboration and license agreement.
Under the first royalty agreement, Regeneron is entitled to receive royalties on
worldwide sales of Novartis’ canakinumab (ACZ885), a
fully human anti-interleukin-IL1ß antibody approved to treat CAPS and in
development for a number of other inflammatory diseases. On the basis of the
same agreement, Regeneron waived its rights to opt-in to the development and
commercialization of canakinumab. Under the second royalty agreement, Novartis
is entitled to receive royalties on worldwide sales of a second-generation
interleukin-1 Trap, should Regeneron decide to proceed in the development of
this Trap. The financial terms of both agreements are identical in relation to
stepped royalties to be paid on the basis of future sales, which start at 4
percent and reach 15 percent when annual sales exceed $1.5 billion. The
agreements do not include any upfront or milestone payments or any sharing of
development expenses.
Financial Results
Revenues
Total
revenues increased to $90.0 million in the second quarter of 2009 from $60.7
million in the same quarter of 2008 and increased to $165.0 million for the
first half of 2009 from $117.0 million for the same period of 2008. The
Company’s revenue was comprised of contract research and development revenue,
technology licensing revenue, and net product sales.
Contract Research and Development
Revenue
Contract research and development revenue
relates primarily to the Company’s aflibercept and antibody collaborations with
sanofi-aventis and the Company’s VEGF Trap-Eye collaboration with Bayer
HealthCare. Contract research and development revenue for the three and six
months ended June 30, 2009 and 2008 consisted of the following:
| Three months ended | Six months ended | |||||||||||
| June 30, | June 30, | |||||||||||
| (In millions) | 2009 | 2008 | 2009 | 2008 | ||||||||
| Contract research & development revenue | ||||||||||||
| Sanofi-aventis | $ | 60.7 | $ | 38.6 | $ | 110.4 | $ | 74.3 | ||||
| Bayer HealthCare | 12.8 | 10.2 | 22.8 | 19.2 | ||||||||
| Other | 2.0 | 1.9 | 3.4 | 3.5 | ||||||||
| Total contract research & development revenue | $ | 75.5 | $ | 50.7 | $ | 136.6 | $ | 97.0 | ||||
For the three and six months ended June 30, 2009 and 2008, contract research and development revenue from sanofi-aventis consisted of the following:
| Three months ended | Six months ended | |||||||||||
| June 30, | June 30, | |||||||||||
| (In millions) | 2009 | 2008 | 2009 | 2008 | ||||||||
| Aflibercept: | ||||||||||||
| Regeneron expense reimbursement | $ | 9.2 | $ | 10.3 | $ | 14.6 | $ | 22.0 | ||||
| Recognition of deferred revenue related to up-front payments | 2.5 | 2.1 | 5.0 | 4.2 | ||||||||
| Total aflibercept | 11.7 | 12.4 | 19.6 | 26.2 | ||||||||
| Antibody: | ||||||||||||
| Regeneron expense reimbursement | 45.7 | 23.6 | 84.1 | 42.9 | ||||||||
| Recognition of deferred revenue related to up-front payment | 2.6 | 2.6 | 5.3 | 5.2 | ||||||||
| Recognition of revenue related to VelociGene® agreement | 0.7 | 1.4 | ||||||||||
| Total antibody | 49.0 | 26.2 | 90.8 | 48.1 | ||||||||
| Total sanofi-aventis contract research & development revenue | $ | 60.7 | $ | 38.6 | $ | 110.4 | $ | 74.3 | ||||
Sanofi-aventis’ reimbursement of Regeneron’s aflibercept expenses decreased for the three and six months ended June 30, 2009, compared to the same periods in 2008, primarily due to lower Company costs associated with internal research activities and manufacturing clinical drug supplies. Sanofi-aventis also incurs aflibercept development expenses directly, including costs related to the Phase 3 clinical trials sanofi-aventis is overseeing in the oncology program.
Sanofi-aventis’ reimbursement of Regeneron’s expenses under the antibody collaboration increased for the three and six months ended June 30, 2009, compared to the same periods in 2008, due to an increase in research activities conducted under the collaboration’s discovery agreement and increases in development activities for REGN88, REGN421, and REGN475 under the collaboration’s license agreement.
For the three and six months ended June 30, 2009 and 2008, contract research and development revenue from Bayer HealthCare consisted of the following:
| Three months ended | Six months ended | |||||||||||
| June 30, | June 30, | |||||||||||
| (In millions) | 2009 | 2008 | 2009 | 2008 | ||||||||
| Cost-sharing of Regeneron VEGF Trap-Eye development | ||||||||||||
| expenses | $ | 10.4 | $ | 6.9 | $ | 17.9 | $ | 12.6 | ||||
| Recognition of deferred revenue related to up-front and | ||||||||||||
| milestone payments | 2.4 | 3.3 | 4.9 | 6.6 | ||||||||
| Total Bayer HealthCare contract research & development | ||||||||||||
| revenue | $ | 12.8 | $ | 10.2 | $ | 22.8 | $ | 19.2 | ||||
In periods when the Company recognizes VEGF Trap-Eye development expenses that the Company incurs under the collaboration with Bayer HealthCare, the Company also recognizes, as contract research and development revenue, the portion of those VEGF Trap-Eye development expenses that is reimbursable by Bayer HealthCare. The Company incurred higher VEGF Trap-Eye development expenses under the collaboration for the three and six months ended June 30, 2009, compared to the same period in 2008, primarily in connection with the collaboration’s clinical development programs in wet AMD, DME, and CRVO.
Technology Licensing
Revenue
Regeneron has entered into non-exclusive
license agreements with AstraZeneca and Astellas that allow those companies to
utilize VelocImmune® technology in their internal
research programs to discover human monoclonal antibodies. Each company is
required to make six $20.0 million annual, non-refundable payments, subject to
the ability to terminate their agreements after making a total of four such
payments. To date, the Company has received $60.0 million in payments from each
of AstraZeneca and Astellas under these agreements. Upon receipt, these payments
are deferred and recognized as revenue ratably over the ensuing year of each
agreement. Regeneron will also receive a mid-single-digit royalty on sales of
any antibodies discovered utilizing VelocImmune.
Net Product Sales
Revenue and deferred revenue from product sales are recorded net of
applicable provisions for prompt pay discounts, product returns, estimated
rebates payable under governmental programs (including Medicaid), distributor
fees, and other sales-related costs. For the three and six months ended June 30,
2009, the Company recognized as revenue $4.5 million and $8.4 million of
ARCALYST® (rilonacept) net product sales,
respectively, for which the right of return no longer exists and rebates can be
reasonably estimated. At June 30, 2009 and 2008, deferred revenue related to
ARCALYST net product sales totaled $4.9 million and $2.3 million,
respectively.
Expenses
Total
operating expenses for the second quarter of 2009 were $106.3 million, 32
percent higher than the same period in 2008, and $198.4 million for the first
six months of 2009, 30 percent higher than the same period in 2008. Average
headcount increased to 966 in the second quarter of 2009 from 771 in the same
period of 2008 and increased to 952 for the first half of 2009 from 742 in the
same period of 2008, due primarily to the Company’s expanding research and
development activities principally in connection with the sanofi-aventis
antibody collaboration. Operating expenses included non-cash compensation
expense related to employee stock option and restricted stock awards of $7.4
million in the second quarter of 2009 and $15.1 million for the first six months
of 2009, compared with $8.2 million and $16.5 million, respectively, for the
same periods of 2008.
Research and development (R&D) expenses increased to $94.2 million in the second quarter of 2009 from $66.8 million in the comparable quarter of 2008, and to $174.5 million in the first six months of 2009 from $128.2 million in the same period of 2008. In the second quarter and first half of 2009, the Company incurred higher R&D costs primarily related to additional R&D headcount, clinical development costs for ARCALYST, VEGF Trap-Eye, and REGN88, research and preclinical development costs associated with the antibody programs, and facility-related costs to support expanded R&D activities.
Selling, general, and administrative (SG&A) expenses decreased to $11.6 million in the second quarter of 2009 from $13.5 million in the comparable quarter of 2008, and to $23.1 million in the first six months of 2009 from $24.5 million in the same period of 2008. In the second quarter and first half of 2009, the Company incurred lower selling expenses related to ARCALYST, lower SG&A recruitment costs, lower market research costs related to various development programs, and lower legal and professional fees related to various corporate matters, which were partly offset by higher compensation expense associated with additional SG&A headcount.
Other Income and Expense
Investment income decreased to $1.3 million in the second quarter of
2009 from $4.5 million in the comparable quarter of 2008 and to $3.1 million in
the first half of 2009 compared to $11.8 million in the first half of 2008. The
decrease in investment income was due to lower yields on, and lower balances of,
cash and marketable securities in 2009 compared to 2008.
Interest expense in the second quarter and first half of 2008 was attributable to the Company’s 5.5 percent Convertible Senior Subordinated Notes; no Notes were outstanding in 2009. In the second quarter of 2008, the Company repurchased $81.3 million in principal amount of these convertible notes, which were due in October 2008, and recognized a $0.9 million loss on early extinguishment of debt.
Revision of Previously Issued Financial
Statements
The Company has revised its financial
statements at December 31, 2008 and for the three and six months ended June 30,
2008, in connection with the application of Emerging Issues Task Force Statement
No. 97-10, The Effect of Lessee Involvement in Asset
Construction (EITF 97-10), to the Company’s December
2006 lease, as amended, of laboratory and office facilities in Tarrytown, New
York. The revisions consisted entirely of non-cash adjustments, primarily to the
Company’s balance sheet at December 31, 2008, and had no impact to the Company’s
business operations, existing capital resources, or the Company’s ability to
fund its operating needs, including the development of its product candidates.
The revisions, and a description of the basis for the revisions, are more fully
described in the Company’s Quarterly Report on Form 10-Q for the quarter ended
June 30, 2009.
About Regeneron
Pharmaceuticals
Regeneron is a fully
integrated biopharmaceutical company that discovers, develops, and
commercializes medicines for the treatment of serious medical conditions. In
addition to ARCALYST® (rilonacept)
Injection for Subcutaneous Use, its first commercialized product, Regeneron has
therapeutic candidates in clinical trials for the potential treatment of cancer,
eye diseases, inflammatory diseases, and pain, and has preclinical programs in
other diseases and disorders. Additional information about Regeneron and recent
news releases are available on Regeneron’s web site at
www.regeneron.com.
This news release discusses historical information and includes forward-looking statements about Regeneron and its products, development programs, finances, and business, all of which involve a number of risks and uncertainties, such as risks associated with preclinical and clinical development of Regeneron’s drug candidates, determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize its product and drug candidates, competing drugs that are superior to Regeneron’s product and drug candidates, uncertainty of market acceptance of Regeneron’s product and drug candidates, unanticipated expenses, the availability and cost of capital, the costs of developing, producing, and selling products, the potential for any collaboration agreement, including Regeneron’s agreements with the sanofi-aventis Group and Bayer HealthCare, to be canceled or to terminate without any product success, risks associated with third party intellectual property, and other material risks. A more complete description of these and other material risks can be found in Regeneron’s filings with the United States Securities and Exchange Commission (SEC), including its Form 10-K for the year ended December 31, 2008 and Form 10-Q for the quarter ended June 30, 2009. Regeneron does not undertake any obligation to update publicly any forward-looking statement, whether as a result of new information, future events, or otherwise unless required by law.
###
| Contacts Information: | |
| Peter Dworkin | Laura Lindsay |
| Investor Relations | Media Relations |
| 914.345.7640 | 914.345.7800 |
| peter.dworkin@regeneron.com | laura.lindsay@regeneron.com |
REGENERON PHARMACEUTICALS, INC.
CONDENSED
BALANCE SHEETS (Unaudited)
(In
thousands)
| June 30, | December 31, | |||||
| 2009 | 2008 | |||||
| (Revised)* | ||||||
| ASSETS | ||||||
| Cash, restricted cash, and marketable securities | $ | 466,363 | $ | 527,461 | ||
| Receivables | 60,046 | 35,212 | ||||
| Property, plant, and equipment, net | 195,408 | 142,035 | ||||
| Other assets | 20,528 | 19,512 | ||||
| Total assets | $ | 742,345 | $ | 724,220 | ||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||
| Accounts payable and accrued expenses | $ | 51,881 | $ | 36,168 | ||
| Deferred revenue | 215,798 | 209,925 | ||||
| Facility lease obligation | 62,925 | 56,019 | ||||
| Other long term liabilities | 1,235 | 594 | ||||
| Stockholders' equity | 410,506 | 421,514 | ||||
| Total liabilities and stockholders' equity | $ | 742,345 | $ | 724,220 | ||
* Revised as described in the paragraph of this press release titled "Revision of Previously Issued Financial Statements."
REGENERON PHARMACEUTICALS,
INC.
CONDENSED STATEMENTS OF OPERATIONS
(Unaudited)
(In thousands, except
per share data)
| For the three months | For the six months | |||||||||||||||
| ended June 30, | ended June 30, | |||||||||||||||
| 2009 | 2008 | 2009 | 2008 | |||||||||||||
| (Revised)* | (Revised)* | |||||||||||||||
| Revenues | ||||||||||||||||
| Contract research and development | $ | 75,532 | $ | 50,653 | $ | 136,622 | $ | 97,036 | ||||||||
| Technology licensing | 10,000 | 10,000 | 20,000 | 20,000 | ||||||||||||
| Net product sales | 4,500 | 8,391 | ||||||||||||||
| 90,032 | 60,653 | 165,013 | 117,036 | |||||||||||||
| Expenses | ||||||||||||||||
| Research and development | 94,231 | 66,777 | 174,538 | 128,246 | ||||||||||||
| Selling, general, and administrative | 11,632 | 13,495 | 23,052 | 24,549 | ||||||||||||
| Cost of goods sold | 435 | 827 | ||||||||||||||
| 106,298 | 80,272 | 198,417 | 152,795 | |||||||||||||
| Loss from operations | (16,266 | ) | (19,619 | ) | (33,404 | ) | (35,759 | ) | ||||||||
| Other income (expense) | ||||||||||||||||
| Investment income | 1,328 | 4,535 | 3,078 | 11,839 | ||||||||||||
| Interest expense | (2,674 | ) | (5,685 | ) | ||||||||||||
| Loss on early extinguishment of debt | (931 | ) | (931 | ) | ||||||||||||
| 1,328 | 930 | 3,078 | 5,223 | |||||||||||||
| Net loss | $ | (14,938 | ) | $ | (18,689 | ) | $ | (30,326 | ) | $ | (30,536 | ) | ||||
| Net loss per share amounts, basic and diluted | $ | (0.19 | ) | $ | (0.24 | ) | $ | (0.38 | ) | $ | (0.39 | ) | ||||
| Weighted average shares outstanding, basic and diluted | 79,626 | 78,689 | 79,562 | 78,591 | ||||||||||||
* Revised as described in the paragraph of this press release titled "Revision of Previously Issued Financial Statements."