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| 8-K - DYAX CORP. 8-K - DYAX CORP | a6699365.htm |
Exhibit 99.1
Dyax Corp. Announces First Quarter 2011 Financial Results
CAMBRIDGE, Mass.--(BUSINESS WIRE)--April 27, 2011--Dyax Corp. (NASDAQ: DYAX) today announced financial results for the first quarter ended March 31, 2011. Dyax will host a webcast and conference call at 5 p.m. (ET) today to review financial results. Senior management will also share updates regarding the company’s three major business franchises and key value drivers - KALBITOR® (ecallantide), the Licensing and Funded Research Program (LFRP) and the internal pipeline, including expansion efforts for KALBITOR.
Highlights of the first quarter 2011 include:
- Patients with KALBITOR start forms reached 742
- Patients with KALBITOR placed at a treatment site reached 435, up 27% from year end
- Patients treating with KALBITOR reached 164, up 64% from year end
- Revenues increased to $8.2 million, including KALBITOR net sales of $4.1 million
- Cash, cash equivalents and investments at March 31, 2011 totaled $66.0 million
“2011 is a year of execution and proving our strategies, and in this first quarter we delivered strong results in all key metrics,” stated Gustav Christensen, President and Chief Executive Officer of Dyax Corp. “KALBITOR sales grew by 35% over the fourth quarter of 2010 and the number of treating patients increased 64% since year end. Furthermore, KALBITOR has shown important commercial progress, and we believe it is changing the treatment paradigm for hereditary angioedema patients.” Mr. Christensen added, “We also expanded our LFRP franchise by adding a funded research partnership with Five Prime Therapeutics.”
First Quarter 2011 Financial Results
Total revenues for the first quarter ended March 31, 2011 were $8.2 million, as compared to $20.0 million for the same quarter in 2010. Included in these revenues were $4.1 million and $1.2 million of net product sales of KALBITOR in 2011 and 2010, respectively. KALBITOR became commercially available during the first quarter of 2010 for treatment of acute attacks of hereditary angioedema (HAE) in patients 16 years of age and older. The 2011 decrease in overall revenue was due to $13.8 million of development and license fee revenue recognized in the first quarter of 2010 following Cubist Pharmaceuticals’ termination of its development of ecallantide for blood loss during cardiac surgery. Quarterly revenues are expected to fluctuate due to the timing and amount of future milestone payments, the clinical activities of our collaborators and licensees, and the timing and completion of contractual commitments.
Cost of product sales for KALBITOR for the first quarter of 2011 were $239,000 as compared to $36,000 for the comparable quarter in 2010. Costs associated with manufacturing KALBITOR drug substance, which were incurred prior to FDA approval, were expensed as research and development costs and, accordingly, are not included in the cost of product sales during the 2011 and 2010 periods reported.
Research and development expenses for the first quarter of 2011 were $7.5 million, as compared to $7.8 million for the same quarter in 2010. The 2011 research and development expenses primarily relate to key Dyax research and development initiatives, which include the following:
- KALBITOR post-marketing requirements;
- Development of a higher strength formulation of KALBITOR;
- Exploring the use of ecallantide for the treatment of ACE inhibitor-induced angioedema; and
- Conducting research on our preclinical pipeline.
Selling, general and administrative expenses for the first quarter of 2011 increased to $9.2 million, as compared to $8.6 million for the same quarter in 2010, primarily due to the expansion of infrastructure to support KALBITOR commercial efforts.
For the quarter ended March 31, 2011, Dyax reported a net loss of $11.3 million or $0.11 per share, as compared to net income of $1.0 million or $0.01 per share for the comparable quarter in 2010. The net income for 2010 was due to the timing of recognition of the $13.8 million of previously deferred revenue under the Cubist agreement.
As of March 31, 2011, Dyax had cash, cash equivalents, and investments totaling $66.0 million, exclusive of restricted cash.
2011 and Long-Term Financial Guidance
Dyax is reiterating its financial guidance for 2011 and beyond, including the following projections:
- 2011 top-line total revenue of $38-44 million, including KALBITOR U.S. sales of $20-24 million
- Cash flow break-even in 2013
- GAAP earnings positive in 2014
- 2016 total revenues of $180-210 million with KALBITOR sales of $110-125 million and LFRP revenue of $70-85 million
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Webcast and Conference Call |
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Date: |
Wednesday, April 27, 2011 | ||
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Time: |
5:00 p.m. ET | ||
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Telephone Access: |
Domestic callers, dial 877-674-2415; reference the Dyax conference call |
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International callers, dial 708-290-1364 |
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| No passcode required. | |||
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Online Access: |
Go to the Investor Relations section of the Dyax website (www.dyax.com) and follow instructions for accessing the live webcast. |
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| Participants may register in advance. | |||
A replay of the conference call will be available through May 27, 2011 and may be accessed by dialing 800-642-1687. International callers should dial 706-645-9291. The replay passcode for all callers is 60664208. The webcast will be archived on the Dyax website for an indefinite period of time.
About KALBITOR® (ecallantide)
KALBITOR is a plasma kallikrein inhibitor indicated for the treatment of acute attacks of hereditary angioedema (HAE) in patients 16 years of age and older. KALBITOR, which was discovered and developed by Dyax, is the first subcutaneous treatment available in the U.S. for treating acute HAE attacks.
Important KALBITOR® Safety Information
Anaphylaxis has been reported after administration of KALBITOR. Because of the risk of anaphylaxis, KALBITOR should only be administered by a healthcare professional with appropriate medical support to manage anaphylaxis and hereditary angioedema. Healthcare professionals should be aware of the similarity of symptoms between hypersensitivity reactions and hereditary angioedema and patients should be monitored closely. KALBITOR should not be administered to patients with known clinical hypersensitivity to KALBITOR.
For more information about KALBITOR, including full prescribing information, visit www.KALBITOR.com.
About HAE
Hereditary angioedema (HAE) is a rare acute inflammatory condition characterized by episodes of severe, often painful swelling affecting the extremities, gastrointestinal tract, genitalia, and larynx. HAE is caused by low or dysfunctional levels of C1 esterase inhibitor (C1-INH), a naturally occurring molecule that inhibits plasma kallikrein, a key mediator of inflammation, and other serine proteases in the blood. HAE is estimated to affect 1 in 10,000 to 1 in 50,000 individuals. Learn more at www.HAEHope.com.
About Dyax
Dyax is a fully integrated biopharmaceutical company focused on discovering, developing and commercializing novel biotherapeutics for unmet medical needs. The Company’s lead product, ecallantide, has been approved under the brand name KALBITOR® in the United States for the treatment of acute attacks of hereditary angioedema (HAE) in patients 16 years of age and older. Dyax is commercializing KALBITOR in the United States independently, and establishing strategic partnerships to develop and commercialize ecallantide for the treatment of HAE in key regions worldwide. Currently, Dyax has partnership agreements for regions including Europe, Japan, Russia, the Middle East, Israel, North Africa, Australia and New Zealand. The company is also exploring other potential indications for ecallantide, either alone or through partnerships, including drug-induced angioedema and retinal vein occlusion-induced macular edema.
Ecallantide 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 as part of its Licensing and Funded Research Program (LFRP), which has 75 revenue generating licenses and collaborations for therapeutic discovery, as well as for affinity separations, diagnostic imaging, and research reagents. The success of the Company’s LFRP royalty portfolio is illustrated by the program’s advanced licensee pipeline that includes 17 candidates in clinical development. Of those candidates, four are in Phase 3 clinical trials, four are in Phase 2 and nine are in Phase 1.
Disclaimer
This press release contains forward-looking statements, including statements regarding achievement of milestones, the prospects for therapeutic benefits and treatment advantages of KALBITOR for HAE and increases in the KALBITOR patient base and treatment rates, revenues for 2011 and 2016, cash flow breakeven in 2013, GAAP earnings in 2014 and LFRP revenues in 2016. 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 and its licensees compete. 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 involved in any future projections, as well as uncertainties associated with various activities and aspects of Dyax’s business, including risks and uncertainties associated with the following: others may develop technologies or products superior to KALBITOR; KALBITOR may not gain market acceptance; uncertainties regarding treatment rates for patients on KALBITOR; Dyax’s dependence on the expertise, effort, priorities and contractual obligations of third parties in the manufacture of KALBITOR worldwide and in the marketing, sales and distribution of KALBITOR outside of the United States; Dyax’s dependence on licensees and collaborators for development, clinical trials, manufacturing, sales and distribution of products; the uncertainty of negotiations with potential partners and collaborators; uncertainty as to whether one or more of Dyax’s licensees’ new product candidates will be generating royalties on commercial sales; 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 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, the Dyax logo, KALBITOR and KALBITOR Access are registered trademarks of Dyax Corp.
- financial tables follow -
| DYAX CORP. | ||||||||||
| SELECTED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||
| (Unaudited) | ||||||||||
| Three Months Ended | ||||||||||
| March 31, | ||||||||||
| 2011 | 2010 | |||||||||
| (In thousands, except share and per share data) | ||||||||||
| Revenues: | ||||||||||
| Product sales, net | $ | 4,107 | $ | 1,243 | ||||||
| Development and license fee revenues | 4,107 | 18,805 | ||||||||
| Total revenues, net | $ | 8,214 | $ | 20,048 | ||||||
| Costs and expenses: | ||||||||||
| Cost of product sales | $ | 239 | $ | 36 | ||||||
| Research and development | 7,495 | 7,769 | ||||||||
| Selling, general and administrative | 9,249 | 8,579 | ||||||||
| Total costs and expenses | 16,983 | 16,384 | ||||||||
| Income (loss) from operations | (8,769 | ) | 3,664 | |||||||
| Other expense, net | (2,496 | ) | (2,710 | ) | ||||||
| Net income (loss) | $ | (11,265 | ) | $ | 954 | |||||
| Basic and diluted net income (loss) per share | $ | (0.11 | ) | $ | 0.01 | |||||
| Shares used in computing basic net income (loss) per share | 98,689,795 | 78,315,589 | ||||||||
| Shares used in computing diluted net income (loss) per share | 98,689,795 | 79,690,854 | ||||||||
| SELECTED CONSOLIDATED CONDENSED BALANCE SHEET INFORMATION | ||||||||||
| (Unaudited) | ||||||||||
| March 31, | December 31, | |||||||||
| 2011 | 2010 | |||||||||
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Assets |
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| Cash, cash equivalents and short-term investments | $ | 65,995 | $ | 77,384 | ||||||
| Accounts receivable, net | 5,006 | 5,315 | ||||||||
| Inventory | 1,930 | 1,696 | ||||||||
| Other current assets | 3,264 | 3,248 | ||||||||
| Restricted cash | 1,471 | 922 | ||||||||
| Total current assets | 77,666 | 88,565 | ||||||||
| Fixed assets and other non-current assets | 2,288 | 2,600 | ||||||||
| Restricted cash | - | 1,266 | ||||||||
| Total assets | $ | 79,954 | $ | 92,431 | ||||||
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Liabilities and Stockholders' Equity (Deficit) |
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| Accounts payable and other current liabilities | $ | 10,106 | $ | 11,958 | ||||||
| Deferred revenue | 20,867 | 21,336 | ||||||||
| Note payable and other long-term debt | 56,178 | 56,504 | ||||||||
| Total liabilities | 87,151 | 89,798 | ||||||||
| Common stock and additional paid-in capital | 446,338 | 444,911 | ||||||||
| Accumulated deficit and other comprehensive income | (453,535 | ) | (442,278 | ) | ||||||
| Total stockholders' equity (deficit) | (7,197 | ) | 2,633 | |||||||
| Total liabilities and stockholders' equity (deficit) | $ | 79,954 | $ | 92,431 | ||||||
CONTACT:
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