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Mike Havrilla submits:The BioMedReports.com FDA Calendar service includes a database with over 400 entries of (1) pending new drug, biological agent,
Dyax Corp. (DYAX)Q3 2009 Earnings CallOctober 28, 2009 10:00 am ETComplete
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Nov 04, 2009 (Close-Up Media via COMTEX) --
Dyax announced financial results for the third quarter ended September 30.
In an October 28 release, Dyax reported that total revenues for the third quarter ended September 30, were $4.5 million, as compared to $5.5 million for the comparable quarter in 2008. Total revenues for the nine months ended September 30, increased to $15.3 million from $12.0 million for the comparable period in 2008. For the nine month 2009 period, the increase in revenues was primarily due to additional revenue recognized under the company's Licensing and Funded Research Program (LFRP), as well as $1.6 million of revenue recognized under a collaboration agreement entered into during 2008. Quarterly revenues are expected to fluctuate due to the timing and amount of future milestone payments, the clinical activities of collaborators and licensees, and the timing and completion of contractual commitments.
Research and development expenses for the third quarter of 2009 decreased to $7.1 million, as compared to $16.5 million for the comparable quarter in 2008. For the nine months ended September 30, research and development expenses decreased to $37.8 million, as compared to $51.6 million for the comparable period in 2008. For the nine month 2009 period, the decrease in expenses was primarily due to cost savings resulting from the restructuring in March 2009, the closure of the company's Liege, Belgium research facility in mid-2008, and lower clinical trials costs. These decreases were offset by an increase of approximately $7.5 million in 2009 costs associated with the manufacture of DX-88.
General and administrative expenses for the third quarter of 2009 increased to $5.9 million, as compared to $4.9 million for the comparable quarter in 2008. For the nine months ended September 30, general and administrative costs increased to $18.9 million, as compared to $15.6 million for the comparable period in 2008. The higher general and administrative costs in 2009 were primarily due to increased infrastructure to support plans for commercialization of DX-88 for hereditary angioedema (HAE) and charges for share-based compensation expense.
For the quarter ended September 30, Dyax reported a net loss of $12.2 million or $0.17 per share, as compared to a net loss of $26.6 million or $0.43 per share for the comparable quarter in 2008. For the nine months ended September 30, the net loss was $51.5 million or $0.78 per share, as compared to $72.9 million or $1.19 per share for the comparable period in 2008.
As of September 30, Dyax had cash, cash equivalents, and short-term investments totaling $41.1 million, exclusive of restricted cash. Inclusive of the $20.5 million of net proceeds from the equity offering completed on October 5, Dyax would have had cash, cash equivalents, and short-term investments totaling $61.6 million, as of September 30.
((Comments on this story may be sent to newsdesk@closeupmedia.com))
Tags: belgium clinical financial results research research and development revenue
Companies: Dyax Corp. (DYAX)
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Companies: Dyax Corp. (DYAX)
CAMBRIDGE, Mass., Nov 07, 2009 (BUSINESS WIRE) --
An analysis demonstrating the ability of DX-88 (ecallantide) to resolve symptoms of acute hereditary angioedema (HAE) attacks in all anatomic locations and to sustain effect will be presented in an oral presentation this week at the American College of Allergy, Asthma and Immunology (ACAAI) 2009 Annual Meeting in Miami Beach. This evaluation, and two others to be presented, highlight efficacy and safety analyses from the integrated analysis of the two Phase 3 placebo-controlled trials, EDEMA3(R) and EDEMA4(R), of DX-88, the lead product candidate of Dyax Corp. (NASDAQ:DYAX), for the treatment of acute attacks of HAE.
In the time to response to treatment analysis, a statistically significant effect over placebo was achieved with DX-88 for two key endpoints: time to sustained improvement (improvement that endured for at least 45 minutes within 4 hours of dosing) (p=0.005) and time to significant improvement (defined as the first time within 4 hours of dosing that a patient reported feeling "a little better" or "a lot better or resolved;" indicates complete or near complete resolution) (p=0.015).
The time of response of the clinical effect appeared to vary with location of the angioedema attack. Abdominal attacks, typically the most painful, and laryngeal attacks, which can be potentially life-threatening, improved more rapidly than peripheral attacks, demonstrating a significant benefit of DX-88 over placebo within 4 hours. The therapeutic effect of DX-88 in peripheral attacks was apparent by 24 hours.
"Positive findings from the clinically stringent hurdle of complete or near complete resolution of an HAE attack provide encouraging evidence that treatment with DX-88 can potentially offer patients a quick and durable treatment for what is often a debilitating attack that can last for several days if untreated," commented Marc Riedl, MD, MS, Assistant Professor of Clinical Immunology and Allergy at the David Geffen School of Medicine at UCLA in Los Angeles. "Of even greater importance is that a rapid response was seen for laryngeal attacks, which can be life-threatening."
A second oral presentation provides data on the pediatric experience of DX-88 for treating acute attacks of HAE. A total of 40 acute HAE attacks were treated with subcutaneously-administered DX-88 in 17 pediatric patients. For these patients, individual attack data were compared to the outcomes for the population receiving the corresponding DX-88 dose in the same study (called the reference group).
Symptom improvement, as measured by change in two patient-reported outcomes measures -- Mean Symptom Complex Severity (MSCS) score and Treatment Outcome Score (TOS) -- were better than or equal to that for the reference group in 75% and 78%, respectively, of acute attacks in pediatric patients four hours after treatment with DX-88. Time to onset of improvement (median: 37 minutes) and time to near complete resolution (median: 82.5 minutes) were shorter than or equal to that for the reference group in 58% and 63%, respectively, of acute attacks. There was a low rate of treatment-related adverse events in pediatric patients treated with 30 mg subcutaneous DX-88. Although hypersensitivity was observed in two pediatric patients treated with intravenous DX-88, no hypersensitivity was observed in the pediatric population following subcutaneous dosing. The efficacy and safety profiles for pediatric patients appeared similar to that of the overall treatment group.
Complete List of Presentations on DX-88 at ACAAI 2009
Oral Presentations
-- Time to Response with Ecallantide for the Treatment of Acute Attacks of Hereditary Angioedema: Results from the EDEMA Development Program -- Marc Riedl, MD, MS, David Geffen School of Medicine at UCLA -- Monday, November 9, 2009, 1:00 PM
-- Ecallantide for the Treatment of Acute Attacks of Hereditary Angioedema in Pediatric Patients: Experience in the EDEMA Development Program -- Andrew J. MacGinnitie, MD, PhD, Children's Hospital of Pittsburgh of UPMC -- Monday, November 9, 2009, 1:45 PM
Poster Presentations
-- Time of Intervention with Ecallantide for the Treatment of Acute Attacks of Hereditary Angioedema: Results from the EDEMA Development Program -- Erin Banta, MD, Milton S. Hershey Medical Center, Hershey, PA -- Saturday, November 7, 2009 and Sunday, November 8, 2009
-- Successful Use of Ecallantide After an Anaphylactoid Reaction -- Henry Li, MD, PhD, FAAAAI, Institute for Asthma and Allergy at Wheaton and Chevy Chase, MD -- Saturday, November 7, 2009 and Sunday, November 8, 2009
About DX-88 for HAE
DX-88, a recombinant, small protein, was discovered utilizing Dyax's proprietary phage display technology and is being evaluated as a subcutaneous therapy for treating acute HAE attacks. DX-88 is a potent and selective plasma kallikrein inhibitor, a key mediator of inflammation in angioedema, and has demonstrated effectiveness in all attack locations, including life-threatening laryngeal attacks. DX-88 has been evaluated in five clinical trials for HAE, including two Phase 3 placebo-controlled trials (EDEMA3 and EDEMA4), which represent the largest placebo-controlled evaluation for this indication. A continuation trial is ongoing.
About HAE
Hereditary angioedema (HAE) is an acute inflammatory condition characterized by episodes of severe, often painful swelling affecting the extremities, the gastrointestinal tract, the genitalia, and in potentially life-threatening cases, the larynx. HAE is caused by low or dysfunctional levels of C1 esterase inhibitor (C1-INH), a naturally occurring molecule that inhibits plasma kallikrein and other serine proteases in the blood.
About Dyax
Dyax is focused on advancing novel biotherapeutics for unmet medical needs, with an emphasis on inflammatory and oncology indications. Dyax utilizes its proprietary drug discovery technology to identify antibody, small protein and peptide compounds for clinical development. Dyax's lead product candidate is DX-88, a recombinant, small protein that is currently being evaluated for its therapeutic potential in three separate indications. On June 1, 2009, Dyax submitted a response to the FDA's Complete Response letter regarding the review of Dyax's Biologics License Application (BLA) of DX-88 for the treatment of hereditary angioedema (HAE). The FDA accepted the submission and assigned Dyax's BLA a new Prescription Drug User Fee Act (PDUFA) action date of December 1, 2009. DX-88 has orphan drug designation in the U.S. and E.U., as well as Fast Track designation in the U.S., for this indication. Additionally, DX-88 is being evaluated in two Phase 2 trials for the reduction of blood loss during on-pump cardiothoracic surgery (CTS), which are being conducted by Dyax's partner, Cubist Pharmaceuticals. Dyax licensed to Cubist the intravenous formulation of DX-88 for surgical indications in North America and Europe. DX-88 is also being evaluated in a Phase 1 trial for retinal vein occlusion-induced macular edema by Dyax's partner, Fovea Pharmaceuticals, which has recently entered into an agreement to be acquired by sanofi-aventis. Dyax licensed to Fovea the ocular formulation of DX-88 for the treatment of retinal diseases in the EU but retains all rights outside of the EU.
DX-88 and other compounds in Dyax's pipeline were identified using its patented phage display technology, which rapidly selects compounds that bind with high affinity and specificity to therapeutic targets. Dyax leverages this technology broadly with over 70 revenue generating licenses and collaborations for therapeutic discovery, as well as in non-core areas such as affinity separations, diagnostic imaging, and research reagents. Dyax is headquartered in Cambridge, Massachusetts. For online information about Dyax Corp., please visit www.dyax.com.
Dyax Disclaimer
This press release contains forward-looking statements, including statements regarding the prospects for therapeutic benefits and treatment advantages of DX-88 for HAE. Statements that are not historical facts are based on Dyax's current expectations, beliefs, assumptions, estimates, forecasts and projections about the industry and markets in which Dyax competes. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors which may affect the prospects for therapeutic benefits and treatment advantages of DX-88 for HAE and include the risks that: DX-88 could take a significantly longer time to gain regulatory approval than Dyax expects or may never gain approval; others may develop technologies or products superior to DX-88 or that are on the market before DX-88; DX-88 may not gain market acceptance; Dyax is dependent on the expertise, effort, priorities and contractual obligations of third parties in the manufacture, marketing, sales and distribution of DX-88 ; and other risk factors described or referred to Item 1A, "Risk Factors" in Dyax's most recent Annual Report on Form 10-K and other periodic reports filed with the Securities and Exchange Commission. Dyax cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Dyax undertakes no obligations to update or revise these statements, except as may be required by law.
Dyax and the Dyax logo are registered trademarks of Dyax Corp. EDEMA3 and EDEMA4 are registered service marks of Dyax.
SOURCE: Dyax Corp.
Dyax Corp. Ivana Magovcevic-Liebisch, 617-250-5759 Executive Vice President Corporate Development and General Counsel imagovcevic@dyax.com or Nicole Jones, 617-250-5744 Director, Investor Relations and Corporate Communications njones@dyax.com
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Companies: Dyax Corp. (DYAX)
CAMBRIDGE, Mass., Oct 28, 2009 (BUSINESS WIRE) --
Dyax Corp. (NASDAQ: DYAX) today announced financial results for the third quarter ended September 30, 2009. Dyax will host a webcast and conference call at 10 a.m. (ET) this morning to review the financial results and corporate progress for the quarter.
Financial Results
Total revenues for the third quarter ended September 30, 2009 were $4.5 million, as compared to $5.5 million for the comparable quarter in 2008. Total revenues for the nine months ended September 30, 2009 increased to $15.3 million from $12.0 million for the comparable period in 2008. For the nine month 2009 period, the increase in revenues was primarily due to additional revenue recognized under the Company's Licensing and Funded Research Program (LFRP), as well as $1.6 million of revenue recognized under a collaboration agreement entered into during 2008. Quarterly revenues are expected to fluctuate due to the timing and amount of future milestone payments, the clinical activities of collaborators and licensees, and the timing and completion of contractual commitments.
Research and development expenses for the third quarter of 2009 decreased to $7.1 million, as compared to $16.5 million for the comparable quarter in 2008. For the nine months ended September 30, 2009, research and development expenses decreased to $37.8 million, as compared to $51.6 million for the comparable period in 2008. For the nine month 2009 period, the decrease in expenses was primarily due to cost savings resulting from the restructuring in March 2009, the closure of the Company's Liege, Belgium research facility in mid-2008, and lower clinical trials costs. These decreases were offset by an increase of approximately $7.5 million in 2009 costs associated with the manufacture of DX-88.
General and administrative expenses for the third quarter of 2009 increased to $5.9 million, as compared to $4.9 million for the comparable quarter in 2008. For the nine months ended September 30, 2009, general and administrative costs increased to $18.9 million, as compared to $15.6 million for the comparable period in 2008. The higher general and administrative costs in 2009 were primarily due to increased infrastructure to support plans for commercialization of DX-88 for hereditary angioedema (HAE) and charges for share-based compensation expense.
For the quarter ended September 30, 2009, Dyax reported a net loss of $12.2 million or $0.17 per share, as compared to a net loss of $26.6 million or $0.43 per share for the comparable quarter in 2008. For the nine months ended September 30, 2009, the net loss was $51.5 million or $0.78 per share, as compared to $72.9 million or $1.19 per share for the comparable period in 2008.
As of September 30, 2009, Dyax had cash, cash equivalents, and short-term investments totaling $41.1 million, exclusive of restricted cash. Inclusive of the $20.5 million of net proceeds from the equity offering completed on October 5, 2009, Dyax would have had cash, cash equivalents, and short-term investments totaling $61.6 million, as of September 30, 2009.
Corporate Progress and Guidance
"Throughout the quarter, we have been diligently advancing the commercial plans for DX-88 for HAE as we approach the Prescription Drug User Fee Act action date of December 1, 2009," stated Gustav Christensen, President and Chief Executive Officer of Dyax. "At the same time, our medical and regulatory teams have continued to respond to inquiries from the FDA as the Agency finalizes its review of our Biologic License Application for DX-88. As a result of these contacts, we recently received clarification from the FDA on the requirements of the Risk Evaluation and Mitigation Strategy (REMS) for the approval of DX-88 for acute attacks of HAE. The Agency has informed us that certain elements of our proposed REMS to assure safe use, particularly the concept of a closed distribution system, will not be required. Our understanding is that an approvable REMS will consist primarily of two components: a medication guide and a communication plan."
Mr. Christensen commented further, "We also saw during the quarter a number of positive developments with our DX-88 partner programs and licensee programs under our LFRP. With respect to our LFRP, three licensees, ImClone, MedImmune and BioInvent each advanced a new product candidate into Phase 1 development. Thus, the expansion and maturation of our licensing program continues to move forward as the LFRP pipeline currently has one marketed drug and 16 product candidates in various stages of clinical development."
2009 Guidance
George Migausky, Executive Vice President and Chief Financial Officer of Dyax, stated, "Over the last two years, we have added capital from multiple sources to support our long-term business strategy. We have added or expanded our partnerships, implemented disciplined cost management and closed significant financial transactions. These actions have strengthened our balance sheet and allowed us to focus the necessary resources on commercial activities for DX-88. At this time, we believe we have the cash and resources to support ongoing operations through 2010."
Webcast and Conference Call
Dyax Corp. will host a webcast and conference call, including an open question and answer session.
Date: Wednesday, October 28, 2009
Time: 10:00 a.m. ET
Telephone Access: Domestic callers, dial 866-383-8119
International callers, dial 617-597-5344
Passcode 61799435
Online Access: Go to the Investor Relations section of the Dyax website
(www.dyax.com)
and follow instructions for accessing the live webcast.
Participants
may register in advance.
A replay of the conference call will be available through November 28, 2009 and may be accessed by dialing 888-286-8010. International callers should dial 617-801-6888. The replay passcode for all callers is 19564625. The webcast will be archived on the Dyax website for an indefinite period of time.
About Dyax
Dyax is focused on advancing novel biotherapeutics for unmet medical needs, with an emphasis on inflammatory and oncology indications. Dyax utilizes its proprietary drug discovery technology to identify antibody, small protein and peptide compounds for clinical development. Dyax's lead product candidate is DX-88 (ecallantide), a recombinant small protein that is currently being developed for its therapeutic potential in two separate indications. On June 1, 2009, Dyax submitted a response to the FDA's Complete Response letter regarding the review of Dyax's Biologics License Application (BLA) of DX-88 for the treatment of hereditary angioedema (HAE). The FDA accepted the submission and assigned Dyax's BLA a new Prescription Drug User Fee Act (PDUFA) action date of December 1, 2009. DX-88 has orphan drug designation in the U.S. and E.U., as well as Fast Track designation in the U.S., for this indication. Additionally, DX-88 is being evaluated in two Phase 2 trials for the reduction of blood loss during on-pump cardiac surgery (CTS), which are being conducted by Dyax's partner in this indication, Cubist Pharmaceuticals. Dyax licensed to Cubist the intravenous formulation of DX-88 for surgical indications in North America and Europe. DX-88 and other compounds in Dyax's pipeline were identified using its patented phage display technology, which rapidly selects compounds that bind with high affinity and specificity to therapeutic targets. Dyax leverages this technology broadly with over 70 revenue generating licenses and collaborations for therapeutic discovery, as well as in non-core areas such as affinity separations, diagnostic imaging, and research reagents. Dyax is headquartered in Cambridge, Massachusetts. For online information about Dyax Corp., please visit www.dyax.com.
Disclaimer
This press release contains forward-looking statements regarding Dyax Corp. These statements include statements regarding Dyax's future cash resources, its projected use of cash and savings from recent cost reductions and its timing and prospects for review and FDA approval of the BLA for DX-88 for HAE. Statements that are not historical facts are based on Dyax's current expectations, beliefs, assumptions, estimates, forecasts and projections for Dyax and the industry and markets in which Dyax competes. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements because of uncertainties associated with various activities and aspects of Dyax's business, including risks and uncertainties associated with the following: DX-88 could take a significantly longer time to gain regulatory approval than Dyax expects or may never gain approval; others may develop technologies or products superior to DX-88; other products are or will be on the market in Europe and the U.S. before DX-88; DX-88 may not achieve market acceptance; Dyax's dependence on collaborators for development, clinical trials, manufacturing, sales and distribution of products; the uncertainty of negotiations with potential partners and collaborators; Dyax's changing requirements and costs associated with planned research and development activities; the uncertainty of patent and intellectual property protection; Dyax's dependence on key management and key suppliers; the impact of future alliances or transactions involving Dyax or others; and other risk factors described or referred to in Item 1A, "Risk Factors" in Dyax's most recent Annual Report on Form 10-K and other periodic reports filed subsequently with the Securities and Exchange Commission. Dyax cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Dyax undertakes no obligation to update or revise these statements, except as may be required by law.
Dyax and the Dyax logo are registered trademarks of Dyax Corp.
DYAX CORP.
SELECTED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Three Months Ended Nine Months Ended
September 30, September 30,
2009 2008 2009 2008
(In thousands, except share and per share data)
Product development and license fee revenues $ 4,508 $ 5,490 $ 15,305 $ 11,964
Operating expenses:
Research and development 7,095 16,502 37,787 51,641
Restructuring costs 395 876 2,331 4,631
Impairment of fixed assets 955 - 955 352
General and administrative 5,923 4,878 18,916 15,645
Total operating expenses 14,368 22,256 59,989 72,269
Loss from operations (9,860 ) (16,766 ) (44,684 ) (60,305 )
Other expense, net (2,333 ) (1,609 ) (6,819 ) (4,317 )
Loss on extinguishment of debt - (8,264 ) - (8,264 )
Net loss $ (12,193 ) $ (26,639 ) $ (51,503 ) $ (72,886 )
Basic and diluted net loss per share $ (0.17 ) $ (0.43 ) $ (0.78 ) $ (1.19 )
Shares used in computing basic and diluted net loss per share 72,485,047 62,439,236 66,452,507 61,173,457
SELECTED CONSOLIDATED CONSENSED BALANCE SHEET INFORMATION
(Unaudited)
September 30, December 31,
2009 2008
(In thousands)
Cash, cash equivalents and investments $ 41,110 $ 58,460
Total assets $ 51,589 $ 75,075
Deferred revenue $ 30,442 $ 31,386
Note payable and other long-term obligations $ 58,901 $ 48,499
Total liabilities $ 100,793 $ 95,119
Total liabilities and stockholders' deficit $ 51,589 $ 75,075
SOURCE: Dyax Corp.
Dyax Corp. George Migausky, 617-250-5733 Executive Vice President and Chief Financial Officer gmigausky@dyax.com or Nicole Jones, 617-250-5744 Director, Investor Relations and Corporate Communications njones@dyax.com
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Companies: Dyax Corp. (DYAX)
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Clinical Trials Introduction Learn More About Dyax's Clinical Trials Hereditary Angioedema On-Pump Heart Surgery (DX-88) Cystic Fibrosis (DX-890) New Clinical Press Releases Patient Resources How Trials Work How Do I Enroll? Helpful Links Glossary
Mr. Frank previously served as a Director of Lehman Brothers. Before joining Lehman Brothers as a Partner in October 1969, Mr. Frank was co-director of research, as well as Vice President and Director, of Smith, Barney & Co. Inc.
The current Phase 2 trial for CTS is a 160-patient, randomized, placebo-controlled trial that will be conducted at ten major U.S. cardiac surgery centers.
http://www.pharmacychoice.com/News/article.cfm?Article_ID=56724
FierceBiotech is the biotech industry daily monitor, with a special focus on drug discovery and clinical trials. Keep up to speed with the latest biotechnology trends, breakthroughs and fda approval news.
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Dyax Corporation financial and business news, updates, and information from The New York Times and other leading providers.
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