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	<title>Symptom Advice .com &#187; second quarter</title>
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		<title>Regeneron Reports Second Quarter 2010 Financial and Operating Results</title>
		<link>http://symptomadvice.com/regeneron-reports-second-quarter-2010-financial-and-operating-results/</link>
		<comments>http://symptomadvice.com/regeneron-reports-second-quarter-2010-financial-and-operating-results/#comments</comments>
		<pubDate>Thu, 26 Aug 2010 17:03:26 +0000</pubDate>
		<dc:creator>Symptom Advice</dc:creator>
				<category><![CDATA[pancreatitis symptoms]]></category>
		<category><![CDATA[december 31]]></category>
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		<category><![CDATA[second quarter]]></category>

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		<description><![CDATA[Posted on: Wednesday, 28 July 2010, 02:00 CDT TARRYTOWN, N.Y., July 28 /PRNewswire-FirstCall/ &#8212; Regeneron Pharmaceuticals, &#105;&#110;&#099;. (Nasdaq: REGN) today announced financial and operating results for &#116;&#104;&#101; second quarter of 2010. &#116;&#104;&#101; Company reported a net loss of $25.5 million, or $0.31 per share (basic and diluted), for &#116;&#104;&#101; second quarter of 2010 compared with [...]]]></description>
			<content:encoded><![CDATA[<p></p><p><img src="http://symptomadvice.com/wp-content/uploads/2010/08/1282842206-78.jpg" style="float:left;clear:both;margin:0 15px 15px 0" />
<p>Posted on: Wednesday, 28 July 2010, 02:00 CDT </p>
<p>TARRYTOWN, N.Y., July 28 /PRNewswire-FirstCall/ &#8212; Regeneron Pharmaceuticals, &#105;&#110;&#099;. (Nasdaq: REGN) today announced financial and operating results for &#116;&#104;&#101; second quarter of 2010. &#116;&#104;&#101; Company reported a net loss of $25.5 million, or $0.31 per share (basic and diluted), for &#116;&#104;&#101; second quarter of 2010 compared with a net loss of $14.9 million, or $0.19 per share (basic and diluted), for &#116;&#104;&#101; second quarter of 2009. &#116;&#104;&#101; Company reported a net loss of $56.0 million, or $0.69 per share (basic and diluted), for &#116;&#104;&#101; six months &#101;&#110;&#100;&#101;&#100; June 30, 2010 compared with a net loss of $30.3 million, or $0.38 per share (basic and diluted), for &#116;&#104;&#101; &#115;&#097;&#109;&#101; period &#105;&#110; 2009.</p>
<p>Regeneron and Astellas Pharma &#105;&#110;&#099;. announced today that Astellas has extended through 2023 &#116;&#104;&#101; non-exclusive license agreement that &#097;&#108;&#108;&#111;&#119;&#115; Astellas &#116;&#111; utilize Regeneron&#8217;s VelocImmune® technology &#105;&#110; &#105;&#116;&#115; internal research programs &#116;&#111; discover fully human monoclonal antibody product candidates. Astellas will pay $165.0 million up-front and another $130.0 million &#105;&#110; June 2018 &#117;&#110;&#108;&#101;&#115;&#115; &#105;&#116; terminates &#116;&#104;&#101; agreement prior &#116;&#111; that date. Upon commercialization of &#097;&#110;&#121; antibody products discovered utilizing VelocImmune®, Astellas will pay &#116;&#104;&#101; Company a mid-single-digit royalty on product sales.</p>
<p>At June 30, 2010, cash, restricted cash, and marketable securities totaled $380.2 million compared with $390.0 million &#097;&#116; December 31, 2009. &#116;&#104;&#101; Company currently estimates that year-end 2010 cash, restricted cash, and marketable securities, including &#116;&#104;&#101; $165.0 million payment &#102;&#114;&#111;&#109; Astellas, will total $425 &#8211; $445 million.</p>
<p><b>Current Business Highlights</b></p>
<p><u>ARCALYST® (rilonacept) &#8211; CAPS</u></p>
<p>Net product sales of ARCALYST® Injection for Subcutaneous Use &#105;&#110; &#116;&#104;&#101; second quarter of 2010 were $5.2 million, compared &#116;&#111; $4.5 million during &#116;&#104;&#101; &#115;&#097;&#109;&#101; period of 2009. &#116;&#104;&#101; Company recognized $15.0 million of net product sales during &#116;&#104;&#101; &#102;&#105;&#114;&#115;&#116; six months of 2010, &#119;&#104;&#105;&#099;&#104; included $10.2 million of ARCALYST® net product sales made during &#116;&#104;&#101; &#102;&#105;&#114;&#115;&#116; &#104;&#097;&#108;&#102; of 2010 and $4.8 million of previously deferred net product sales, &#097;&#115; described &#098;&#101;&#108;&#111;&#119; under &#8220;Financial Results.&#8221; &#105;&#110; &#116;&#104;&#101; &#102;&#105;&#114;&#115;&#116; six months of 2009, &#116;&#104;&#101; Company recognized $8.4 million of ARCALYST® net product sales. </p>
<p>ARCALYST® is available for prescription &#105;&#110; &#116;&#104;&#101; United States for &#116;&#104;&#101; treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial &#099;&#111;&#108;&#100; Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) &#105;&#110; adults and children 12 and older. ARCALYST® is a fusion protein that blocks &#116;&#104;&#101; cytokine interleukin-1 (IL-1). CAPS is a group of rare, inherited, auto-inflammatory conditions characterized &#098;&#121; life-long, recurrent symptoms of rash, fever/chills, joint pain, eye redness/pain, and fatigue. </p>
<p><u>ARCALYST® (rilonacept) &#8211; Gout</u></p>
<p>ARCALYST® is &#105;&#110; a Phase 3 clinical development program for &#116;&#104;&#101; prevention of gout flares &#105;&#110; patients initiating uric acid-lowering therapy. &#105;&#110; June 2010, &#116;&#104;&#101; Company announced that a Phase 3 study (called PRE-SURGE 1) &#105;&#110; gout patients initiating allopurinol therapy &#116;&#111; &#108;&#111;&#119;&#101;&#114; their uric acid levels &#115;&#104;&#111;&#119;&#101;&#100; that ARCALYST® prevented gout attacks, &#097;&#115; measured &#098;&#121; &#116;&#104;&#101; primary study endpoint of &#116;&#104;&#101; number of gout flares per patient &#111;&#118;&#101;&#114; &#116;&#104;&#101; 16 week treatment period. Patients &#119;&#104;&#111; received ARCALYST® &#097;&#116; a weekly, self-administered, subcutaneous dose of 160 milligrams (mg) had &#097;&#110; 80% decrease &#105;&#110; mean number of gout flares compared &#116;&#111; &#116;&#104;&#101; placebo group &#111;&#118;&#101;&#114; &#116;&#104;&#101; 16 week treatment period (0.21 flares vs. 1.06 flares, p&lt;0.0001). Patients &#119;&#104;&#111; received ARCALYST® &#097;&#116; a weekly dose of 80 mg had a 73% decrease compared &#116;&#111; &#116;&#104;&#101; placebo group (0.29 flares vs. 1.06 flares, p&lt;0.0001). </p>
<p>All secondary endpoints of &#116;&#104;&#101; study were highly positive (p&lt;0.001 vs. placebo). &#097;&#109;&#111;&#110;&#103; these secondary endpoints, treatment with ARCALYST® reduced &#116;&#104;&#101; proportion of patients &#119;&#104;&#111; experienced two or &#109;&#111;&#114;&#101; flares during &#116;&#104;&#101; study period &#098;&#121; up &#116;&#111; 88% (3.7% with ARCALYST® 160 mg, 5.0% with ARCALYST® 80 mg, and 31.6% with placebo, p&lt;0.0001). &#105;&#110; addition, treatment with ARCALYST® reduced &#116;&#104;&#101; proportion of patients &#119;&#104;&#111; experienced &#097;&#116; &#108;&#101;&#097;&#115;&#116; one gout flare during &#116;&#104;&#101; study period &#098;&#121; up &#116;&#111; 65% (16.3% with ARCALYST® 160 mg, 18.8% with, ARCALYST® 80 mg, and 46.8% with placebo, p&lt;0.001). </p>
<p>A total of 241 patients were randomized &#105;&#110; PRE-SURGE 1, a North America-based double-blind, placebo-controlled study. ARCALYST® &#119;&#097;&#115; generally well tolerated with &#110;&#111; reported drug-related &#115;&#101;&#114;&#105;&#111;&#117;&#115; adverse events. Injection site reaction, generally considered mild, &#119;&#097;&#115; &#116;&#104;&#101; &#109;&#111;&#115;&#116; commonly reported adverse event with ARCALYST®.</p>
<p>In addition, &#105;&#110; June 2010, &#116;&#104;&#101; Company reported results &#102;&#114;&#111;&#109; a placebo-controlled, Phase 3 study (called SURGE) &#105;&#110; patients presenting with &#097;&#110; acute gout flare. &#116;&#104;&#101; results of &#116;&#104;&#105;&#115; study &#115;&#104;&#111;&#119;&#101;&#100; that &#116;&#104;&#101;&#114;&#101; &#119;&#097;&#115; &#110;&#111; significant benefit &#102;&#114;&#111;&#109; combining ARCALYST® with indomethacin (a non-sterodial anti-inflammatory drug considered &#116;&#104;&#101; standard of care), &#097;&#115; measured &#098;&#121; &#116;&#104;&#101; primary study endpoint of &#116;&#104;&#101; average intensity of gout pain &#102;&#114;&#111;&#109; 24 &#116;&#111; 72 hours &#097;&#102;&#116;&#101;&#114; initiation of treatment. Patients treated with indomethacin &#097;&#108;&#111;&#110;&#101; experienced &#097;&#110; average reduction &#105;&#110; patient-reported pain scores (0 &#116;&#111; 4 Likert scale &#119;&#104;&#101;&#114;&#101; 0 represents &#110;&#111; pain and 4 represents extreme pain) of 1.40 points &#102;&#114;&#111;&#109; baseline compared &#116;&#111; &#097;&#110; average reduction of 1.55 points &#102;&#114;&#111;&#109; baseline &#105;&#110; patients treated with &#098;&#111;&#116;&#104; indomethacin and ARCALYST® (p=0.33). Patients &#119;&#104;&#111; received ARCALYST® &#097;&#108;&#111;&#110;&#101; experienced &#097;&#110; average pain reduction of 0.69 points. Treatment with ARCALYST® &#119;&#097;&#115; generally well tolerated with &#110;&#111; reported drug-related &#115;&#101;&#114;&#105;&#111;&#117;&#115; adverse events. &#116;&#104;&#101; &#109;&#111;&#115;&#116; commonly reported adverse event with ARCALYST® &#119;&#097;&#115; headache.</p>
<p>There &#097;&#114;&#101; two ongoing studies &#105;&#110; &#116;&#104;&#101; Phase 3 program with ARCALYST® &#105;&#110; &#116;&#104;&#101; prevention of gout flares &#105;&#110; patients initiating uric acid-lowering therapy. &#116;&#104;&#101; global PRE-SURGE 2 study, &#119;&#104;&#105;&#099;&#104; has a similar trial design &#097;&#115; PRE-SURGE 1, is evaluating &#116;&#104;&#101; number of gout flares per patient &#111;&#118;&#101;&#114; &#116;&#104;&#101; &#102;&#105;&#114;&#115;&#116; 16 weeks of initiation of allopurinol therapy. &#116;&#104;&#101; global RE-SURGE study is evaluating &#116;&#104;&#101; safety of ARCALYST® &#118;&#101;&#114;&#115;&#117;&#115; placebo &#111;&#118;&#101;&#114; 16 weeks &#105;&#110; patients &#119;&#104;&#111; &#097;&#114;&#101; &#097;&#116; risk for gout flares &#098;&#101;&#099;&#097;&#117;&#115;&#101; &#116;&#104;&#101;&#121; &#097;&#114;&#101; &#116;&#097;&#107;&#105;&#110;&#103; uric acid-lowering drug treatment. PRE-SURGE 2 is fully enrolled and RE-SURGE is &#111;&#118;&#101;&#114; 90% enrolled. Data &#102;&#114;&#111;&#109; &#098;&#111;&#116;&#104; studies &#097;&#114;&#101; expected &#105;&#110; early 2011. Regeneron owns worldwide rights &#116;&#111; ARCALYST®. </p>
<p><u>VEGF Trap-Eye</u><u> </u><u>- Ophthalmologic Diseases</u></p>
<p>VEGF Trap-Eye is a specially purified and formulated form of VEGF Trap, &#119;&#104;&#105;&#099;&#104; is &#098;&#101;&#105;&#110;&#103; developed for use &#105;&#110; &#116;&#104;&#101; intraocular treatment of retinal diseases. VEGF Trap-Eye blocks vascular endothelial growth factor A (VEGF-A), a secreted protein &#119;&#104;&#105;&#099;&#104; promotes &#116;&#104;&#101; growth of blood vessels. &#105;&#116; also binds other mediators of angiogenesis, including VEGF-B and Placental Growth Factor (PlGF). VEGF Trap-Eye is &#098;&#101;&#105;&#110;&#103; developed &#098;&#121; Regeneron &#105;&#110; collaboration with Bayer HealthCare. Bayer HealthCare has rights &#116;&#111; market VEGF Trap-Eye outside &#116;&#104;&#101; United States, &#119;&#104;&#101;&#114;&#101; &#116;&#104;&#101; companies will share equally &#105;&#110; profits &#102;&#114;&#111;&#109; &#097;&#110;&#121; future sales of VEGF Trap-Eye. Regeneron maintains exclusive rights &#116;&#111; VEGF Trap-Eye &#105;&#110; &#116;&#104;&#101; United States. </p>
<p>Two Phase 3 studies (VIEW 1 and VIEW 2) evaluating VEGF Trap-Eye (aflibercept iso-osmotic ophthalmic) &#105;&#110; patients with &#116;&#104;&#101; neovascular form of age-related macular degeneration (wet AMD) &#097;&#114;&#101; fully enrolled, and initial data &#102;&#114;&#111;&#109; these studies &#097;&#114;&#101; expected &#105;&#110; &#116;&#104;&#101; fourth quarter of 2010. &#105;&#110; addition, Regeneron and Bayer HealthCare &#097;&#114;&#101; conducting two Phase 3 studies (COPERNICUS and GALILEO) &#105;&#110; central retinal vein occlusion (CRVO). COPERNICUS is fully enrolled and GALILEO is &#111;&#118;&#101;&#114; 90% enrolled. Initial data &#097;&#114;&#101; anticipated &#102;&#114;&#111;&#109; &#098;&#111;&#116;&#104; studies &#105;&#110; early 2011. </p>
<p>In February 2010, Regeneron and Bayer HealthCare announced results of a Phase 2 study (called DA VINCI) &#105;&#110; patients with clinically significant diabetic macular edema (DME). &#105;&#110; &#116;&#104;&#101; study, VEGF Trap-Eye achieved &#116;&#104;&#101; primary study endpoint of a statistically significant improvement &#105;&#110; visual acuity &#111;&#118;&#101;&#114; 24 weeks compared &#116;&#111; focal laser therapy, &#116;&#104;&#101; standard of care &#105;&#110; DME. VEGF Trap-Eye &#119;&#097;&#115; generally well-tolerated, and &#110;&#111; ocular or non-ocular drug-related &#115;&#101;&#114;&#105;&#111;&#117;&#115; adverse events were reported. Following &#116;&#104;&#101; initial 24 weeks of treatment, patients continue &#116;&#111; be treated for another 24 weeks on &#116;&#104;&#101; &#115;&#097;&#109;&#101; dosing regimens. Initial one-year results will be available later &#105;&#110; 2010.</p>
<p><u>Aflibercept (VEGF Trap) &#8211; Oncology</u></p>
<p>Aflibercept (VEGF Trap) is &#098;&#101;&#105;&#110;&#103; developed worldwide &#098;&#121; Regeneron and &#105;&#116;&#115; collaborator, sanofi-aventis, for &#116;&#104;&#101; potential treatment of solid tumors. &#116;&#104;&#114;&#101;&#101; randomized, double-blind, Phase 3 trials, &#097;&#108;&#108; of &#119;&#104;&#105;&#099;&#104; &#097;&#114;&#101; fully enrolled, &#097;&#114;&#101; evaluating combinations of standard chemotherapy regimens with &#101;&#105;&#116;&#104;&#101;&#114; aflibercept or placebo for &#116;&#104;&#101; treatment of cancer. One trial (called VELOUR) is evaluating aflibercept &#097;&#115; a 2nd-line treatment for metastatic colorectal cancer &#105;&#110; combination with FOLFIRI (folinic acid [leucovorin], 5-fluorouracil, and irinotecan). A second trial (VITAL) is evaluating aflibercept &#097;&#115; a 2nd-line treatment for locally advanced or metastatic non-small cell lung cancer &#105;&#110; combination with docetaxel. &#116;&#104;&#101; third trial (VENICE) is evaluating aflibercept &#097;&#115; a 1st-line treatment for metastatic castration-resistant prostate cancer &#105;&#110; combination with docetaxel/prednisone. Based on projected event rates, &#097;&#110; interim analysis of VELOUR is expected &#116;&#111; be conducted &#098;&#121; &#097;&#110; independent statistician and reviewed &#098;&#121; &#097;&#110; Independent Data Monitoring Committee (IDMC) &#105;&#110; &#116;&#104;&#101; second &#104;&#097;&#108;&#102; of 2010. &#097;&#110; IDMC is a body of independent clinical and statistical experts that meets periodically &#116;&#111; evaluate data &#102;&#114;&#111;&#109; &#116;&#104;&#101; studies. Final results &#102;&#114;&#111;&#109; &#116;&#104;&#101; VITAL study &#097;&#114;&#101; anticipated &#105;&#110; &#116;&#104;&#101; &#102;&#105;&#114;&#115;&#116; &#104;&#097;&#108;&#102; of 2011 and &#102;&#114;&#111;&#109; &#116;&#104;&#101; VELOUR study &#105;&#110; &#116;&#104;&#101; second &#104;&#097;&#108;&#102; of 2011. Based on projected event rates, &#097;&#110; interim analysis of VENICE is expected &#116;&#111; be reviewed &#098;&#121; &#097;&#110; IDMC &#105;&#110; mid-2011, with final results anticipated &#105;&#110; 2012. </p>
<p>In addition, a randomized Phase 2 study (AFFIRM) is evaluating aflibercept &#097;&#115; a 1st-line treatment for metastatic colorectal cancer &#105;&#110; combination with FOLFOX (folinic acid [leucovorin], 5-fluorouracil, and oxaliplatin). &#116;&#104;&#101; AFFIRM study is fully enrolled, and initial data &#097;&#114;&#101; anticipated &#105;&#110; &#116;&#104;&#101; second &#104;&#097;&#108;&#102; of 2011. </p>
<p><u>Monoclonal Antibodies</u></p>
<p>Since 2007, Regeneron and sanofi-aventis &#104;&#097;&#118;&#101; collaborated on &#116;&#104;&#101; discovery, development, and commercialization of fully human monoclonal antibodies generated &#098;&#121; Regeneron using &#105;&#116;&#115; VelocImmune® technology. During &#116;&#104;&#101; fourth quarter of 2009, Regeneron and sanofi-aventis expanded and extended their collaboration with &#116;&#104;&#101; objective &#116;&#111; advance &#097;&#110; average of four &#116;&#111; &#102;&#105;&#118;&#101; antibodies into clinical development each year between 2010 and 2017. &#116;&#104;&#101;&#114;&#101; &#097;&#114;&#101; &#102;&#105;&#118;&#101; antibody candidates currently &#105;&#110; clinical development under &#116;&#104;&#101; collaboration: </p>
<p><u>REGN727</u>, &#097;&#110; antibody &#116;&#111; PCSK9, a &#110;&#111;&#118;&#101;&#108; target for LDL cholesterol reduction, is &#105;&#110; Phase 1 studies using &#098;&#111;&#116;&#104; intravenous and subcutaneous routes of administration. &#105;&#110; &#109;&#097;&#121; 2010, &#116;&#104;&#101; Company announced that &#105;&#110; &#097;&#110; interim efficacy analysis of a dose-escalating, randomized, double-blind, placebo-controlled, Phase 1 trial &#105;&#110; healthy volunteers, REGN727 achieved substantial, dose dependent decreases of LDL (bad) cholesterol. Each dosing cohort consisted of six treated and two placebo patients. &#105;&#110; July 2010, &#116;&#104;&#101; Company presented additional data &#102;&#114;&#111;&#109; &#116;&#104;&#101; Phase 1 program. &#097;&#116; &#116;&#104;&#101; highest intravenous doses tested, a single dose of REGN727 achieved a greater &#116;&#104;&#097;&#110; 60% maximum mean reduction of LDL cholesterol &#102;&#114;&#111;&#109; baseline that lasted for &#109;&#111;&#114;&#101; &#116;&#104;&#097;&#110; one month. &#097;&#116; &#116;&#104;&#101; highest subcutaneous doses tested, a single dose of REGN727 achieved a greater &#116;&#104;&#097;&#110; 60% maximum mean reduction of LDL cholesterol &#102;&#114;&#111;&#109; baseline that lasted for &#109;&#111;&#114;&#101; &#116;&#104;&#097;&#110; two weeks. &#110;&#111; &#115;&#101;&#114;&#105;&#111;&#117;&#115; adverse events and &#110;&#111; dose limiting toxicities &#104;&#097;&#118;&#101; been reported. Dose escalation is ongoing &#105;&#110; &#098;&#111;&#116;&#104; studies. </p>
<p>In July 2010, &#116;&#104;&#101; Company also presented &#116;&#104;&#101; results of &#097;&#110; interim efficacy analysis of a dose escalating, randomized, double-blind, placebo-controlled Phase 1 trial of subcutaneously delivered REGN727 &#105;&#110; hyperlipidemic patients (familial hypercholesterolemia and non-familial hypercholesterolemia) on stable doses of statins whose LDL levels were greater &#116;&#104;&#097;&#110; 100 milligrams per deciliter (mg/dL). &#097;&#116; &#116;&#104;&#101; highest dose tested to-date, &#105;&#110; &#101;&#108;&#101;&#118;&#101;&#110; patients, a single dose of REGN727 achieved &#097;&#110; approximately 40% maximum mean reduction of LDL cholesterol &#102;&#114;&#111;&#109; baseline. &#110;&#111; &#115;&#101;&#114;&#105;&#111;&#117;&#115; adverse events and &#110;&#111; dose limiting toxicities &#104;&#097;&#118;&#101; been reported. Dose escalation &#105;&#110; &#116;&#104;&#105;&#115; study is ongoing.</p>
<p><u>REGN88</u>, &#097;&#110; antibody &#116;&#111; &#116;&#104;&#101; interleukin-6 receptor (IL-6R), has completed Phase 1 studies, &#116;&#104;&#101; results of &#119;&#104;&#105;&#099;&#104; were presented &#097;&#116; &#116;&#104;&#101; annual meeting of &#116;&#104;&#101; European League &#097;&#103;&#097;&#105;&#110;&#115;&#116; Rheumatism (EULAR) &#105;&#110; June 2010. REGN88 &#119;&#097;&#115; well tolerated &#098;&#121; patients with rheumatoid arthritis, and &#110;&#111; dose limiting toxicities were reported. Treatment with REGN88 resulted &#105;&#110; dose-related reductions &#105;&#110; biomarkers of inflammation. A Phase 2/3 study of REGN88 &#105;&#110; rheumatoid arthritis and a Phase 2 study &#105;&#110; ankylosing spondylitis, a form of arthritis that primarily affects &#116;&#104;&#101; spine, &#097;&#114;&#101; enrolling patients.</p>
<p><u>REGN421</u>, &#097;&#110; antibody &#116;&#111; Delta-like ligand-4 (Dll4), a &#110;&#111;&#118;&#101;&#108; anti-angiogenesis target, is &#105;&#110; a Phase 1 study &#105;&#110; patients with advanced malignancies. </p>
<p><u>REGN668</u>, &#097;&#110; antibody &#116;&#111; &#116;&#104;&#101; interleukin-4 receptor (IL-4R), a target for allergic and immune conditions, has completed Phase 1 testing &#105;&#110; healthy volunteers and will be entering a Phase 2 study &#105;&#110; patients with atopic dermatitis &#105;&#110; &#116;&#104;&#101; second &#104;&#097;&#108;&#102; of 2010.</p>
<p><u>REGN475</u>, &#097;&#110; antibody &#116;&#111; nerve growth factor (NGF), is &#098;&#101;&#105;&#110;&#103; evaluated &#105;&#110; Phase 2 studies &#105;&#110; osteoarthritis of &#116;&#104;&#101; knee and other pain indications. &#105;&#110; &#109;&#097;&#121; 2010, &#116;&#104;&#101; Company announced &#097;&#110; interim efficacy analysis of a randomized, double-blind, four-arm, placebo-controlled Phase 2 trial &#105;&#110; 217 patients with osteoarthritis of &#116;&#104;&#101; knee. &#105;&#110; July 2010, &#116;&#104;&#101; Company presented additional results &#102;&#114;&#111;&#109; &#116;&#104;&#105;&#115; trial through 16 weeks. &#116;&#104;&#101; primary endpoint of &#116;&#104;&#105;&#115; study is safety, and REGN475 &#119;&#097;&#115; generally well tolerated. &#115;&#101;&#114;&#105;&#111;&#117;&#115; treatment emergent adverse events were rare. &#116;&#104;&#101; &#109;&#111;&#115;&#116; frequent adverse events reported &#097;&#109;&#111;&#110;&#103; patients receiving REGN475 included sensory abnormalities, arthralgias, hyper/hypo-reflexia, peripheral edema, and injection site reactions. </p>
<p>In &#116;&#104;&#101; &#102;&#105;&#114;&#115;&#116; interim efficacy analysis, REGN475 demonstrated significant improvements &#097;&#116; &#116;&#104;&#101; two highest doses tested &#097;&#115; compared &#116;&#111; placebo &#105;&#110; average walking pain scores &#111;&#118;&#101;&#114; 8 weeks following a single intravenous infusion (p&lt;0.01). &#105;&#110; July 2010, &#116;&#104;&#101; Company reported that REGN475 demonstrated significant improvements &#097;&#116; &#116;&#104;&#101; two highest doses tested &#097;&#115; compared &#116;&#111; placebo &#105;&#110; average walking pain scores &#111;&#118;&#101;&#114; 16 weeks following a second intravenous infusion &#097;&#116; week 8 (p&lt;0.01). Pain &#119;&#097;&#115; measured &#098;&#121; &#116;&#104;&#101; Numeric Rating Scale (NRS), &#097;&#115; well &#097;&#115; &#116;&#104;&#101; Western Ontario and McMaster Osteoarthritis Index (WOMAC) pain and function subscales. </p>
<p>At &#116;&#104;&#101; request of &#116;&#104;&#101; FDA, another pharmaceutical company has suspended &#105;&#116;&#115; anti-NGF antibody clinical program &#105;&#110; osteoarthritis and certain other chronic pain indications. Regeneron has responded &#116;&#111; FDA requests for information &#097;&#098;&#111;&#117;&#116; patients &#105;&#110; &#116;&#104;&#101; Company&#8217;s REGN475 clinical trials. REGN475 is currently &#110;&#111;&#116; on clinical hold, and &#116;&#104;&#101; Company&#8217;s Phase 2 trials &#105;&#110; patients with vertebral &#102;&#114;&#097;&#099;&#116;&#117;&#114;&#101; pain and chronic pancreatitis pain &#097;&#114;&#101; ongoing. &#116;&#104;&#101; Company&#8217;s Phase 2 trial &#105;&#110; osteoarthritis of &#116;&#104;&#101; knee has been completed. &#116;&#104;&#101; Company will update &#105;&#116;&#115; plans for REGN475 following feedback &#102;&#114;&#111;&#109; &#116;&#104;&#101; FDA.</p>
<p><u>REGN910:</u> Regeneron plans &#116;&#111; file &#097;&#110; Investigational New Drug Application for a sixth antibody candidate, REGN910, &#097;&#110; antibody &#116;&#111; Angiopoietin-2, a &#110;&#111;&#118;&#101;&#108; anti-angiogenesis target, &#098;&#121; &#116;&#104;&#101; &#101;&#110;&#100; of 2010. </p>
<p><b>Financial Results</b></p>
<p><u>Cash and Marketable Securities</u></p>
<p>At June 30, 2010, cash, restricted cash, and marketable securities totaled $380.2 million compared with $390.0 million &#097;&#116; December 31, 2009. During &#116;&#104;&#101; &#102;&#105;&#114;&#115;&#116; &#104;&#097;&#108;&#102; of 2010, &#116;&#104;&#101; Company received $47.5 million &#102;&#114;&#111;&#109; &#105;&#116;&#115; landlord &#105;&#110; connection with tenant improvement costs for new laboratory and office facilities that &#116;&#104;&#101; Company leases &#105;&#110; Tarrytown, New York. &#105;&#110; addition, &#116;&#104;&#101; Company received $20.0 million annual technology licensing payments &#102;&#114;&#111;&#109; each of AstraZeneca and Astellas during &#116;&#104;&#101; &#102;&#105;&#114;&#115;&#116; six months of 2010, &#097;&#115; described &#098;&#101;&#108;&#111;&#119;.</p>
<p><u>Revenues</u></p>
<p>Total revenues increased &#116;&#111; $115.9 million &#105;&#110; &#116;&#104;&#101; second quarter of 2010 &#102;&#114;&#111;&#109; $90.0 million &#105;&#110; &#116;&#104;&#101; &#115;&#097;&#109;&#101; quarter of 2009 and increased &#116;&#111; $219.4 million for &#116;&#104;&#101; &#102;&#105;&#114;&#115;&#116; &#104;&#097;&#108;&#102; of 2010 &#102;&#114;&#111;&#109; $165.0 million for &#116;&#104;&#101; &#115;&#097;&#109;&#101; period of 2009. &#116;&#104;&#101; Company&#8217;s revenue &#119;&#097;&#115; comprised of collaboration revenue, technology licensing revenue, net product sales, and contract research and other revenue. </p>
<p>Collaboration Revenue</p>
<p>Collaboration revenue relates &#116;&#111; &#116;&#104;&#101; Company&#8217;s aflibercept and antibody collaborations with sanofi-aventis and &#116;&#104;&#101; Company&#8217;s VEGF Trap-Eye collaboration with Bayer HealthCare. Collaboration revenue for &#116;&#104;&#101; &#116;&#104;&#114;&#101;&#101; and six months &#101;&#110;&#100;&#101;&#100; June 30, 2010 and 2009 consisted of &#116;&#104;&#101; following:</p>
<p> &#116;&#104;&#114;&#101;&#101; months &#101;&#110;&#100;&#101;&#100; Six months &#101;&#110;&#100;&#101;&#100; June 30, June 30, &#8212;&#8212;&#8211; &#8212;&#8212;&#8211; (In millions) 2010 2009 2010 2009 &#8212;- &#8212;- &#8212;- &#8212;- Collaboration revenue Sanofi-aventis $84.9 $60.7 $153.6 $110.4 Bayer HealthCare 13.7 12.8 26.7 22.8 &#8212; &#8211; &#8212; &#8211; Total collaboration revenue $98.6 $73.5 $180.3 $133.2 ===== ===== ====== ======
<p>For &#116;&#104;&#101; &#116;&#104;&#114;&#101;&#101; and six months &#101;&#110;&#100;&#101;&#100; June 30, 2010 and 2009, collaboration revenue &#102;&#114;&#111;&#109; sanofi-aventis consisted of &#116;&#104;&#101; following:</p>
<p> &#116;&#104;&#114;&#101;&#101; months &#101;&#110;&#100;&#101;&#100; Six months &#101;&#110;&#100;&#101;&#100; June 30, June 30, &#8212;&#8212;&#8211; &#8212;&#8212;&#8211; (In millions) 2010 2009 2010 2009 &#8212;- &#8212;- &#8212;- &#8212;- Aflibercept: Regeneron expense reimbursement $3.8 $9.2 $8.7 $14.6 Recognition of deferred revenue related &#116;&#111; up-front payments 2.5 2.5 5.0 5.0 &#8212; &#8212; &#8212; &#8212; Total aflibercept 6.3 11.7 13.7 19.6 &#8212; &#8212;- &#8212;- &#8212;- Antibody: Regeneron expense reimbursement 76.4 45.7 135.8 84.1 Recognition of deferred revenue related &#116;&#111; up-front and other payments 1.8 2.6 3.3 5.3 Recognition of revenue related &#116;&#111; VelociGene(R) agreement 0.4 0.7 0.8 1.4 &#8212; &#8212; &#8212; &#8212; Total antibody 78.6 49.0 139.9 90.8 &#8212;- &#8212;- &#8212;&#8211; &#8212;- Total sanofi-aventis collaboration revenue $84.9 $60.7 $153.6 $110.4 ===== ===== ====== ======
<p>Sanofi-aventis&#8217; reimbursement of Regeneron&#8217;s aflibercept expenses decreased for &#116;&#104;&#101; &#116;&#104;&#114;&#101;&#101; and six months &#101;&#110;&#100;&#101;&#100; June 30, 2010, compared &#116;&#111; 2009, due &#116;&#111; &#108;&#111;&#119;&#101;&#114; costs related &#116;&#111; manufacturing aflibercept clinical supplies &#097;&#115; well &#097;&#115; a decrease &#105;&#110; internal research activities. Sanofi-aventis also incurs aflibercept development expenses &#100;&#105;&#114;&#101;&#099;&#116;&#108;&#121;, including costs related &#116;&#111; &#116;&#104;&#101; Phase 3 clinical trials sanofi-aventis is overseeing. </p>
<p>Sanofi-aventis&#8217; reimbursement of Regeneron&#8217;s expenses under &#116;&#104;&#101; antibody collaboration increased for &#116;&#104;&#101; &#116;&#104;&#114;&#101;&#101; and six months &#101;&#110;&#100;&#101;&#100; June 30, 2010, compared &#116;&#111; &#116;&#104;&#101; &#115;&#097;&#109;&#101; periods &#105;&#110; 2009, due &#116;&#111; &#097;&#110; increase &#105;&#110; research activities under &#116;&#104;&#101; companies&#8217; expanded collaboration, &#097;&#115; described &#097;&#098;&#111;&#118;&#101;, and increases &#105;&#110; development activities for antibody candidates &#105;&#110; clinical development. </p>
<p>For &#116;&#104;&#101; &#116;&#104;&#114;&#101;&#101; and six months &#101;&#110;&#100;&#101;&#100; June 30, 2010 and 2009, collaboration revenue &#102;&#114;&#111;&#109; Bayer HealthCare consisted of &#116;&#104;&#101; following:</p>
<p> &#116;&#104;&#114;&#101;&#101; months &#101;&#110;&#100;&#101;&#100; Six months &#101;&#110;&#100;&#101;&#100; June 30, June 30, &#8212;&#8212;&#8211; &#8212;&#8212;&#8211; (In millions) 2010 2009 2010 2009 &#8212;- &#8212;- &#8212;- &#8212;- Cost-sharing of Regeneron VEGF Trap-Eye development expenses $11.2 $10.4 $21.8 $17.9 Recognition of deferred revenue related &#116;&#111; up-front and milestone payments 2.5 2.4 4.9 4.9 &#8212; &#8212; &#8212; &#8212; Total Bayer HealthCare collaboration revenue $13.7 $12.8 $26.7 $22.8 ===== ===== ===== =====
<p>In periods when &#116;&#104;&#101; Company recognizes VEGF Trap-Eye development expenses that &#116;&#104;&#101; Company incurs under &#116;&#104;&#101; collaboration with Bayer HealthCare, &#116;&#104;&#101; Company also recognizes, &#097;&#115; collaboration revenue, &#116;&#104;&#101; portion of those VEGF Trap-Eye development expenses that is reimbursable &#098;&#121; Bayer HealthCare. Cost-sharing of &#116;&#104;&#101; Company&#8217;s VEGF Trap-Eye development expenses with Bayer HealthCare increased for &#116;&#104;&#101; &#116;&#104;&#114;&#101;&#101; and six months &#101;&#110;&#100;&#101;&#100; June 30, 2010, compared &#116;&#111; &#116;&#104;&#101; &#115;&#097;&#109;&#101; period &#105;&#110; 2009, due &#116;&#111; higher costs incurred &#098;&#121; &#116;&#104;&#101; Company &#105;&#110; connection with &#116;&#104;&#101; collaboration&#8217;s clinical development programs &#105;&#110; wet AMD, DME, and CRVO. &#105;&#110; 2010 and 2009, development expenses incurred &#098;&#121; Regeneron and Bayer HealthCare under &#116;&#104;&#101; VEGF Trap-Eye global development plan were shared equally. </p>
<p>Technology Licensing Revenue</p>
<p>Regeneron has entered into non-exclusive license agreements with AstraZeneca and Astellas that &#097;&#108;&#108;&#111;&#119; those companies &#116;&#111; utilize VelocImmune® technology &#105;&#110; their internal research programs &#116;&#111; discover human monoclonal antibodies. &#116;&#111; date, &#116;&#104;&#101; Company has received four $20.0 million annual, non-refundable payments &#102;&#114;&#111;&#109; each of AstraZeneca and Astellas under these agreements. Upon receipt, these payments &#097;&#114;&#101; deferred and recognized &#097;&#115; revenue ratably &#111;&#118;&#101;&#114; &#116;&#104;&#101; ensuing year of each agreement. </p>
<p>Revenue and deferred revenue &#102;&#114;&#111;&#109; product sales &#097;&#114;&#101; 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. &#116;&#104;&#101; Company had limited historical return experience for ARCALYST® (rilonacept) beginning with initial sales &#105;&#110; 2008 through &#116;&#104;&#101; &#101;&#110;&#100; of 2009; therefore, ARCALYST® net product sales were deferred &#117;&#110;&#116;&#105;&#108; &#116;&#104;&#101; right of return &#110;&#111; longer existed and rebates could be reasonably estimated. Effective &#105;&#110; &#116;&#104;&#101; &#102;&#105;&#114;&#115;&#116; quarter of 2010, &#116;&#104;&#101; Company determined that &#105;&#116; had accumulated sufficient historical data &#116;&#111; reasonably estimate &#098;&#111;&#116;&#104; product returns and rebates of ARCALYST®. &#097;&#115; a result, $4.8 million of previously deferred ARCALYST® net product sales were recognized &#097;&#115; revenue &#105;&#110; &#116;&#104;&#101; &#102;&#105;&#114;&#115;&#116; quarter of 2010. </p>
<p>ARCALYST® net product sales totaled $5.2 million and $4.5 million for &#116;&#104;&#101; &#116;&#104;&#114;&#101;&#101; months &#101;&#110;&#100;&#101;&#100; June 30, 2010 and 2009, respectively, and $15.0 million and $8.4 million for &#116;&#104;&#101; six months &#101;&#110;&#100;&#101;&#100; June 30, 2010 and 2009, respectively. ARCALYST® net product sales during &#116;&#104;&#101; &#102;&#105;&#114;&#115;&#116; six months of 2010 included $10.2 million of net product sales made during &#116;&#104;&#105;&#115; period and $4.8 million of previously deferred net product sales, &#097;&#115; described &#097;&#098;&#111;&#118;&#101;. &#116;&#104;&#101;&#114;&#101; &#119;&#097;&#115; &#110;&#111; deferred ARCALYST® net product sales revenue &#097;&#116; June 30, 2010. &#097;&#116; June 30, 2009, deferred ARCALYST® net product sales revenue &#119;&#097;&#115; $4.9 million. </p>
<p><u>Expenses</u></p>
<p>Total operating expenses for &#116;&#104;&#101; second quarter of 2010 were $139.6 million, 31 percent higher &#116;&#104;&#097;&#110; &#116;&#104;&#101; &#115;&#097;&#109;&#101; period &#105;&#110; 2009, and $272.0 million for &#116;&#104;&#101; &#102;&#105;&#114;&#115;&#116; six months of 2010, 37 percent higher &#116;&#104;&#097;&#110; &#116;&#104;&#101; &#115;&#097;&#109;&#101; period &#105;&#110; 2009. Average headcount increased &#116;&#111; 1,214 &#105;&#110; &#116;&#104;&#101; second quarter of 2010 &#102;&#114;&#111;&#109; 966 &#105;&#110; &#116;&#104;&#101; &#115;&#097;&#109;&#101; period of 2009 and increased &#116;&#111; 1,151 for &#116;&#104;&#101; &#102;&#105;&#114;&#115;&#116; &#104;&#097;&#108;&#102; of 2010 &#102;&#114;&#111;&#109; 952 &#105;&#110; &#116;&#104;&#101; &#115;&#097;&#109;&#101; period of 2009, due primarily &#116;&#111; &#116;&#104;&#101; Company&#8217;s expanding research and development activities, principally &#105;&#110; connection with &#116;&#104;&#101; sanofi-aventis antibody collaboration. Operating expenses included non-cash compensation expense related &#116;&#111; employee stock option and restricted stock awards of $8.7 million &#105;&#110; &#116;&#104;&#101; second quarter of 2010 and $17.5 million for &#116;&#104;&#101; &#102;&#105;&#114;&#115;&#116; six months of 2010, compared with $7.4 million and $15.1 million, respectively, for &#116;&#104;&#101; &#115;&#097;&#109;&#101; periods of 2009. </p>
<p>Research and development (R&amp;D) expenses increased &#116;&#111; $124.5 million &#105;&#110; &#116;&#104;&#101; second quarter of 2010 &#102;&#114;&#111;&#109; $94.2 million &#105;&#110; &#116;&#104;&#101; comparable quarter of 2009 and &#116;&#111; $242.0 million &#105;&#110; &#116;&#104;&#101; &#102;&#105;&#114;&#115;&#116; six months of 2010 &#102;&#114;&#111;&#109; $174.5 million &#105;&#110; &#116;&#104;&#101; &#115;&#097;&#109;&#101; period of 2009. &#105;&#110; &#116;&#104;&#101; second quarter and &#102;&#105;&#114;&#115;&#116; &#104;&#097;&#108;&#102; of 2010, &#116;&#104;&#101; Company incurred higher R&amp;D costs, primarily related &#116;&#111; additional R&amp;D headcount and clinical development costs, manufacturing clinical supplies, and research and other development activities &#097;&#115;&#115;&#111;&#099;&#105;&#097;&#116;&#101;&#100; with &#116;&#104;&#101; Company&#8217;s monoclonal antibody programs. &#105;&#110; addition, R&amp;D expenses include cost-sharing of Bayer HealthCare&#8217;s VEGF Trap-Eye development expenses, &#119;&#104;&#105;&#099;&#104; increased &#105;&#110; &#116;&#104;&#101; second quarter and &#102;&#105;&#114;&#115;&#116; &#104;&#097;&#108;&#102; of 2010 compared &#116;&#111; &#116;&#104;&#101; &#115;&#097;&#109;&#101; periods &#105;&#110; 2009, primarily due &#116;&#111; higher costs &#105;&#110; connection with &#116;&#104;&#101; Phase 3 VEGF Trap-Eye studies &#098;&#101;&#105;&#110;&#103; conducted &#098;&#121; Bayer HealthCare. </p>
<p>Selling, general, and administrative (SG&amp;A) expenses increased &#116;&#111; $14.7 million &#105;&#110; &#116;&#104;&#101; second quarter of 2010 &#102;&#114;&#111;&#109; $11.7 million &#105;&#110; &#116;&#104;&#101; comparable quarter of 2009, and &#116;&#111; $28.9 million &#105;&#110; &#116;&#104;&#101; &#102;&#105;&#114;&#115;&#116; six months of 2010 &#102;&#114;&#111;&#109; $23.1 million &#105;&#110; &#116;&#104;&#101; &#115;&#097;&#109;&#101; period of 2009. &#105;&#110; &#116;&#104;&#101; second quarter and &#102;&#105;&#114;&#115;&#116; &#104;&#097;&#108;&#102; of 2010, &#116;&#104;&#101; Company incurred higher SG&amp;A compensation expense due primarily &#116;&#111; additional headcount, higher Non-cash Compensation Expense, and higher recruitment costs. </p>
<p><u>Other Income and Expense </u></p>
<p>Investment income decreased &#116;&#111; $0.6 million &#105;&#110; &#116;&#104;&#101; second quarter of 2010 &#102;&#114;&#111;&#109; $1.3 million &#105;&#110; &#116;&#104;&#101; comparable quarter of 2009 and &#116;&#111; $1.0 million &#105;&#110; &#116;&#104;&#101; &#102;&#105;&#114;&#115;&#116; six months of 2010 compared &#116;&#111; $3.1 million &#105;&#110; &#116;&#104;&#101; &#115;&#097;&#109;&#101; period of 2009. &#116;&#104;&#101; decrease &#105;&#110; investment income &#119;&#097;&#115; primarily due &#116;&#111; &#108;&#111;&#119;&#101;&#114; balances of, and &#108;&#111;&#119;&#101;&#114; yields on, cash and marketable securities &#105;&#110; 2010 compared &#116;&#111; 2009. </p>
<p>Interest expense of $2.3 million &#105;&#110; &#116;&#104;&#101; second quarter of 2010 and $4.4 million &#105;&#110; &#116;&#104;&#101; &#102;&#105;&#114;&#115;&#116; six months of 2010 &#119;&#097;&#115; attributable &#116;&#111; &#116;&#104;&#101; imputed interest portion of &#116;&#104;&#101; Company&#8217;s payments &#116;&#111; &#105;&#116;&#115; landlord &#116;&#111; lease newly constructed laboratory and office facilities &#105;&#110; Tarrytown, New York. These payments commenced &#105;&#110; &#116;&#104;&#101; third quarter of 2009. </p>
<p><b>About Regeneron Pharmaceuticals</b></p>
<p>Regeneron is a fully integrated biopharmaceutical company that discovers, develops, and commercializes medicines for &#116;&#104;&#101; treatment of &#115;&#101;&#114;&#105;&#111;&#117;&#115; medical conditions. &#105;&#110; addition &#116;&#111; ARCALYST® (rilonacept) Injection for Subcutaneous Use, &#105;&#116;&#115; &#102;&#105;&#114;&#115;&#116; commercialized product, Regeneron has therapeutic candidates &#105;&#110; Phase 3 clinical trials for &#116;&#104;&#101; potential treatment of gout, diseases of &#116;&#104;&#101; eye (wet age-related macular degeneration and central retinal vein occlusion), and certain cancers. Additional therapeutic candidates developed &#102;&#114;&#111;&#109; proprietary Regeneron technologies for &#099;&#114;&#101;&#097;&#116;&#105;&#110;&#103; fully human monoclonal antibodies &#097;&#114;&#101; &#105;&#110; earlier stage development programs &#105;&#110; rheumatoid arthritis and other inflammatory conditions, pain, cholesterol reduction, allergic and immune conditions, and cancer. Additional information &#097;&#098;&#111;&#117;&#116; Regeneron and recent news releases &#097;&#114;&#101; available on Regeneron&#8217;s web site &#097;&#116; <u>regeneron.com</u>.</p>
<p>This news release discusses historical information and includes forward-looking statements &#097;&#098;&#111;&#117;&#116; Regeneron and &#105;&#116;&#115; products, development programs, finances, and business, &#097;&#108;&#108; of &#119;&#104;&#105;&#099;&#104; involve a number of risks and uncertainties. These include, &#097;&#109;&#111;&#110;&#103; others, risks and timing &#097;&#115;&#115;&#111;&#099;&#105;&#097;&#116;&#101;&#100; with preclinical and clinical development of Regeneron&#8217;s drug candidates, determinations &#098;&#121; regulatory and administrative governmental authorities &#119;&#104;&#105;&#099;&#104; &#109;&#097;&#121; delay or restrict Regeneron&#8217;s ability &#116;&#111; continue &#116;&#111; develop or commercialize &#105;&#116;&#115; product and drug candidates, competing drugs that &#097;&#114;&#101; superior &#116;&#111; Regeneron&#8217;s product and drug candidates, uncertainty of market acceptance of Regeneron&#8217;s product and drug candidates, unanticipated expenses, &#116;&#104;&#101; availability and cost of capital, &#116;&#104;&#101; costs of developing, producing, and selling products, &#116;&#104;&#101; potential for &#097;&#110;&#121; collaboration agreement, including Regeneron&#8217;s agreements with &#116;&#104;&#101; sanofi-aventis Group and Bayer HealthCare, &#116;&#111; be canceled or terminated &#119;&#105;&#116;&#104;&#111;&#117;&#116; &#097;&#110;&#121; product success, and risks &#097;&#115;&#115;&#111;&#099;&#105;&#097;&#116;&#101;&#100; with third party intellectual property. A &#109;&#111;&#114;&#101; complete description of these and other material risks &#099;&#097;&#110; be found &#105;&#110; Regeneron&#8217;s filings with &#116;&#104;&#101; United States Securities and Exchange Commission (SEC), including &#105;&#116;&#115; Form 10-K for &#116;&#104;&#101; year &#101;&#110;&#100;&#101;&#100; December 31, 2009 and Form 10-Q for &#116;&#104;&#101; quarter &#101;&#110;&#100;&#101;&#100; June 30, 2010. Regeneron does &#110;&#111;&#116; undertake &#097;&#110;&#121; obligation &#116;&#111; update publicly &#097;&#110;&#121; forward-looking statement, &#119;&#104;&#101;&#116;&#104;&#101;&#114; &#097;&#115; a result of new information, future events, or otherwise, &#117;&#110;&#108;&#101;&#115;&#115; required &#098;&#121; law.</p>
<p> Contacts Information: Michael Aberman, M.D. Peter Dworkin Investor Relations Corporate Communications 914.345.7799 914.345.7640 michael.aberman@regeneron.&#099;&#111;&#109; peter.dworkin@regeneron.&#099;&#111;&#109; &#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8212;&#8211; REGENERON PHARMACEUTICALS, INC. CONDENSED BALANCE SHEETS (Unaudited) (In thousands) December June 30, 31, 2010 2009 &#8212;- &#8212;- ASSETS Cash, restricted cash, and marketable securities $380,202 $390,010 Receivables 95,196 65,568 Property, plant, and equipment, net 292,329 259,676 Other assets 22,914 25,948 &#8212;&#8212; &#8212;&#8212; Total assets $790,641 $741,202 ======== ======== LIABILITIES AND STOCKHOLDERS&#8217; EQUITY Accounts payable, accrued expenses, and other liabilities $62,574 $52,990 Deferred revenue 199,044 182,428 Facility lease obligations 157,807 109,022 Stockholders&#8217; equity 371,216 396,762 &#8212;&#8212;- &#8212;&#8212;- Total liabilities and stockholders&#8217; equity $790,641 $741,202 ======== ======== REGENERON PHARMACEUTICALS, INC. CONDENSED STATEMENTS OF OPERATIONS (Unaudited) (In thousands, except per share data) For &#116;&#104;&#101; &#116;&#104;&#114;&#101;&#101; months For &#116;&#104;&#101; six months &#101;&#110;&#100;&#101;&#100; June 30, &#101;&#110;&#100;&#101;&#100; June 30, 2010 2009 2010 2009 &#8212;- &#8212;- &#8212;- &#8212;- Revenues Collaboration revenue $98,576 $73,578 $180,334 $133,186 Technology licensing 10,037 10,000 20,075 20,000 Net product sales 5,197 4,500 15,049 8,391 Contract research and other 2,076 1,954 3,962 3,436 &#8212;&#8211; &#8212;&#8211; &#8212;&#8211; &#8212;&#8211; 115,886 90,032 219,420 165,013 &#8212;&#8212;- &#8212;&#8212; &#8212;&#8212;- &#8212;&#8212;- Expenses Research and development 124,526 94,231 241,997 174,538 Selling, general, and administrative 14,679 11,632 28,902 23,052 Cost of goods sold 405 435 1,122 827 &#8212; &#8212; &#8212;&#8211; &#8212; 139,610 106,298 272,021 198,417 &#8212;&#8212;- &#8212;&#8212;- &#8212;&#8212;- &#8212;&#8212;- Loss &#102;&#114;&#111;&#109; operations (23,724) (16,266) (52,601) (33,404) &#8212;&#8212;- &#8212;&#8212;- &#8212;&#8212;- &#8212;&#8212;- Other income (expense) Investment income 592 1,328 1,031 3,078 Interest expense (2,342) (4,426) &#8212;&#8212; (1,750) 1,328 (3,395) 3,078 &#8212;&#8212; &#8212;&#8211; &#8212;&#8212; &#8212;&#8211; Net loss $(25,474) $(14,938) $(55,996) $(30,326) ======== ======== ======== ======== Net loss per share amounts, basic and diluted $(0.31) $(0.19) $(0.69) $(0.38) Weighted average shares outstanding, basic and diluted 81,492 79,626 81,330 79,562
<p>SOURCE Regeneron Pharmaceuticals, &#105;&#110;&#099;.</p>
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