Dyax Corp. Announces First Quarter Financial Results.CAMBRIDGE, Mass. -- Dyax Corp. (Nasdaq: DYAX) today announced financial results for the first quarter ended March 31, 2006. The Company will host a webcast and conference call at 10 a.m. (ET) this morning to report financial results and corporate progress for the quarter, and to provide an update on the Company's lead DX-88 program in hereditary angioedema Hereditary angioedema A complement deficiency characterized by lymphatic vessel blockages that cause temporary swelling (edema) of areas of the skin, mucous membranes, and, sometimes, internal organs. Mentioned in: Complement Deficiencies (HAE). Financial Results: For the quarter ended March 31, 2006, the Company reported a net loss of $10.0 million or $0.26 per share, as compared to a net loss of $8.4 million or $0.27 per share for the comparable quarter of 2005. On January 1, 2006, the Company adopted Statement of Financial Accounting Standards No. 123 (revised 2004), "Accounting for Stock-Based Compensation". For the quarter ended March 31, 2006, we recorded an expense for stock-based compensation of $499,000, which is included in research and development and general and administrative expenses in our Selected Consolidated Statement of Operations See Income statement. . Revenues for the first quarter ended March 31, 2006 decreased to $2.7 million as compared to $3.7 million for the same quarter in 2005. This decrease primarily relates to a significant clinical milestone payment received and recognized in the first quarter of 2005; the decrease in revenues associated with our DX-890 product collaboration Working together on a project. See collaborative software. with Debiopharm and the conclusion, in late 2005, of a patent license arrangement for the use of phage display phage display n. A technique using recombinant DNA technology to create bacteriophages with a desired peptide embedded in the surface of their protein shells. in the separations field of use. The receipt and recognition of clinical milestones received from our collaborators and licensees may vary substantially from quarter-to-quarter due to the timing of their clinical activities. Under our amended a·mend v. a·mend·ed, a·mend·ing, a·mends v.tr. 1. To change for the better; improve: amended the earlier proposal so as to make it more comprehensive. 2. agreement with Debiopharm, signed in December 2005, we are no longer responsible for manufacturing DX-890 for Debiopharm. This change is also reflected in a comparable decrease in research and development expenses. During 2006, we will be reimbursed for the completion of our DX-890 activities including the transfer of technology to Debiopharm. Year over year quarterly research and development expenses remained consistent at $10.6 million, but there were changes in the type of expenses incurred. During the first quarter of 2006, our development and personnel costs increased. These increases were offset by decreased manufacturing costs associated with the restructuring restructuring - The transformation from one representation form to another at the same relative abstraction level, while preserving the subject system's external behaviour (functionality and semantics). of the DX-890 product collaboration with Debiopharm, and decreased license expenses. As of March 31, 2006, Dyax had a total of $73.8 million in cash, cash equivalents, and short term investments, exclusive of restricted cash, an increase of $23.1 million from December 31, 2005. This increase resulted primarily from our $30.1 million in net cash proceeds from our underwritten common stock offering in March 2006, less our operating cash requirements for the quarter. The main reason for raising these funds was to allow us to proceed with a Phase IIb trial in on-pump CABG CABG coronary artery bypass graft. CABG abbr. coronary artery bypass graft CABG Coronary artery bypass graft, see there surgery as well as move forward our other clinical leads. Corporate Progress: Henry E. Blair, Chairman and Chief Executive Officer of Dyax, remarked, "We continued to make positive clinical progress during the first quarter, especially in our lead indication for DX-88 in hereditary angioedema. In our Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA (EDEMA edema (ĭdē`mə), abnormal accumulation of fluid in the body tissues or in the body cavities causing swelling or distention of the affected parts. 3) placebo-controlled and ongoing, open-label trial open-label trial Clinical research A trial in which doctors and participants know which therapy is being administered. See Blinding. , patients are being treated ahead of schedule. To date, over 50% of our clinical trial sites have received IRB IRB See: Industrial Revenue Bond approval and are enrolling patients and over a third of the 62 patients have been treated. Contingent upon Adj. 1. contingent upon - determined by conditions or circumstances that follow; "arms sales contingent on the approval of congress" contingent on, dependant on, dependant upon, dependent on, dependent upon, depending on, contingent the successful and timely completion of the EDEMA3 trial and other developmental activities, we anticipate being in a position to receive U.S. regulatory approval by the end of 2007, closely followed by E.U. approval. The Dyax-Genzyme team remains firmly committed to bringing this product to the market for the HAE community." With regard to our Phase II (EDEMA2) trial, Mr. Blair commented, "At the end of January, we completed our EDEMA2 trial in which we treated 240 attacks, with the last 66 attacks being treated through subcutaneous subcutaneous /sub·cu·ta·ne·ous/ (sub?ku-ta´ne-us) beneath the skin. sub·cu·ta·ne·ous adj. Abbr. s.c., SQ Located, found, or placed just beneath the skin; hypodermic. administration. In addition, we presented topline results from the EDEMA2 trial at the AAAAI AAAAI American Academy of Allergy Asthma and Immunology conference in March, which included positive data on both the intravenous intravenous /in·tra·ve·nous/ (-ve´nus) within a vein or veins.intrave´nously in·tra·ve·nous adj. Abbr. IV Within or administered into a vein. and subcutaneous routes of administration. All types of attacks were successfully treated, including life-threatening laryngeal laryngeal /lar·yn·ge·al/ (lah-rin´je-al) pertaining to the larynx. la·ryn·geal or la·ryn·gal adj. Of, relating to, affecting, or near the larynx. attacks, and the overall median time to onset of improvement was 28 minutes, with the subcutaneous administration being slightly lower at 20 minutes. Furthermore, we are currently designing a Phase IIb study for DX-88 in on-pump CABG surgery to be started in the second half of 2006." Mr. Blair continued, "During the quarter, particularly in the area of drug discovery, we continued to work on our DX-2240 antibody for oncology oncology /on·col·o·gy/ (ong-kol´ah-je) the sum of knowledge regarding tumors; the study of tumors. on·col·o·gy n. indications and also advanced our DX-2300 antibody for inflammatory indications into formal development. We look forward to filing an IND in 2007 for DX-2240, with DX-2300 planned to follow shortly thereafter. A presentation on DX-2240 data will be given on April 28, 2006 at the 3rd Annual Cambridge Healthtech Institute Monoclonal Antibodies This is a list of monoclonal antibodies, antibodies which are clones of a single parent cell. When used as medications, the generic names end in -mab (see "Nomenclature of monoclonal antibodies"). Conference in Boston." 2006 Guidance: Regarding Dyax's financial outlook for the year 2006, Stephen S Stephen, 1097?–1154, king of England (1135–54). The son of Stephen, count of Blois and Chartres, and Adela, daughter of William I of England, he was brought up by his uncle, Henry I of England, who presented him with estates in England and France and . Galliker, Executive Vice President of Finance & Administration and Chief Financial Officer of Dyax, commented, "We believe that existing cash and cash equivalents plus anticipated cash flow from product revenues and collaborations will be sufficient to support our current operating plans into 2008. Currently, we expect our net cash consumption for the year 2006 to be approximately $40 million. This increase from our year end 2005 cash consumption estimate results from our decision to initiate a Phase IIb trial in on-pump CABG surgery." Webcast and Conference Call Dyax Corp. will host a webcast and conference call, including an open question and answer session to discuss first quarter 2006 financial results and company progress. Date: Wednesday, April 26, 2006 Time: 10:00 a.m. ET Telephone Access: Domestic callers, dial 866-356-4441 International callers, dial 617-597-5396 Passcode I.D. 64393435 Online Access: Go to the Investor Relations Investor relations The process by which the corporation communicates with its investors. section of the Dyax website (www.dyax.com) and follow instructions for live webcast. Participants may register in advance. A replay of the conference call will be available through May 26, 2006 and can be accessed by dialing 888-286-8010. International callers should dial 617-801-6888. The replay passcode I.D. for all callers is 44277519. The webcast will be archived on the Dyax website for an indefinite INDEFINITE. That which is undefined; uncertain. INDEFINITE, NUMBER. A number which may be increased or diminished at pleasure. 2. When a corporation is composed of an indefinite number of persons, any number of them consisting of a majority of those period of time. About Dyax Dyax Corp. is focused on advancing novel biotherapeutics for unmet un·met adj. Not satisfied or fulfilled: unmet demands. medical needs, with an emphasis on cancer and inflammatory indications. Dyax utilizes its proprietary drug discovery technology to identify antibody, small protein and peptide peptide, organic compound composed of amino acids linked together chemically by peptide bonds. The peptide bond always involves a single covalent link between the α-carboxyl (oxygen-bearing carbon) of one amino acid and the amino nitrogen of a second amino acid. compounds for clinical development. Dyax's lead product candidate is DX-88, a recombinant recombinant /re·com·bi·nant/ (re-kom´bi-nant) 1. the new entity (e.g., gene, protein, cell, individual) that results from genetic recombination. 2. pertaining or relating to such an entity. See also under DNA. small protein that is currently in clinical trials for its therapeutic potential in two separate indications. In its joint venture with Genzyme Corporation, Dyax has successfully completed three Phase II trials of DX-88 for the treatment of hereditary angioedema (HAE). A pivotal Phase III trial is ongoing. Independently, Dyax has successfully completed a Phase I/II trial of DX-88 for the prevention of blood loss during heart surgery (CABG procedures) and is planning a Phase IIb trial while it continues partnering discussions for further development of DX-88 in this indication. DX-88 has orphan drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the designation in the U.S. and E.U., as well as Fast Track designation in the U.S., for the treatment of HAE. Dyax identified DX-88 and other compounds in its pipeline using Dyax's patented phage display technology, which rapidly selects compounds that bind with high affinity and specificity to therapeutic targets. Dyax leverages its technology broadly with over 75 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 This article is about the city of Cambridge in Massachusetts. For the English university town, see Cambridge, England. For other places, see Cambridge (disambiguation). Cambridge, Massachusetts is a city in the Greater Boston area of Massachusetts, United States. , and has antibody discovery facilities in Liege liege In European feudal society, an unconditional bond between a man and his overlord. Thus, if a tenant held estates from various overlords, his obligations to his liege lord, to whom he had paid “liege homage,” were greater than his obligations to the other , Belgium. For online information about Dyax Corp., please visit www.dyax.com. Disclaimer (networking) disclaimer - Statement ritually appended to many Usenet postings (sometimes automatically, by the posting software) reiterating the fact (which should be obvious, but is easily forgotten) that the article reflects its author's opinions and not necessarily those of the This press release contains forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. regarding Dyax Corp., including statements regarding its future cash resources, projected use of cash, antibody discovery technology, clinical trials of DX-88 and plans for clinical development of other compounds, and ongoing and future collaborations and licenses. 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 timing and results of clinical trials, regulatory review of Dyax's products and related trials for approval, Dyax's efforts to develop and commercialize novel products, its dependence on collaborators for development, clinical trials, manufacturing, sales and distribution of products developed by or licensed to collaborators, its changing requirements and costs associated with planned research and development activities, intense competition, 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 Dyax's most recent Annual Report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 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 obligation to update or revise these statements, except as may be required by law. Dyax and the Dyax logo are the registered trademarks of Dyax Corp. EDEMA2 and EDEMA3 are service marks of Dyax Corp.
DYAX CORP.
SELECTED CONSOLIDATED STATEMENT OF OPERATIONS
(Unaudited)
Three Months Ended
March 31,
---------------------------
2006 2005
------------- -------------
(In thousands, except share
and per share data)
Product development and license fee
revenues $ 2,674 $ 3,707
Operating expenses:
Research and development (1) 10,592 10,562
less: Research and development expenses
reimbursed
by joint venture (3,907) (4,028)
Equity loss in joint venture 2,445 2,194
General and administrative(2) 3,854 3,437
------------- -------------
Total operating expenses 12,984 12,165
------------- -------------
Loss from operations (10,310) (8,458)
Other income, net of expense 313 11
------------- -------------
Net loss $ (9,997) $ (8,447)
============= =============
Basic and diluted net loss per share $ (0.26) $ (0.27)
============= =============
Shares used in computing basic and diluted
net loss per share 39,106,230 31,581,465
============= =============
(1) Includes $286 of stock-based compensation expense for the three
months ended March 31, 2006.
(2) Includes $213 of stock-based compensation expense for the three
months ended March 31, 2006.
SELECTED CONSOLIDATED BALANCE SHEET INFORMATION
(Unaudited)
March 31, December 31,
2006 2005
------------- -------------
(In thousands)
Cash and cash equivalents $ 35,620 $ 8,640
Short term investments 38,183 42,024
Restricted cash 4,410 4,408
Working capital 61,165 41,756
Total assets 96,310 75,917
Stockholders' equity 61,789 40,938
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