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8-K - DYAX CORP. 8-K - DYAX CORPa50046393.htm

Exhibit 99.1

Dyax Corp. Announces Third Quarter 2011 Financial Results

CAMBRIDGE, Mass.--(BUSINESS WIRE)--October 27, 2011--Dyax Corp. (NASDAQ: DYAX) today announced financial results for the third quarter ended September 30, 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 third quarter 2011 include:

  • Revenues of $10.1 million, including KALBITOR net sales of $6.6 million, a 27% increase over Q2 2011
  • Patients with KALBITOR placed reached 644, up 18% from Q2 2011
  • Patients treating with KALBITOR reached 307, up 25% from Q2 2011

“Execution on building our business continued in the third quarter,” stated Gustav Christensen, President and Chief Executive Officer of Dyax Corp. “KALBITOR sales grew by 27% over the second quarter of 2011 and we continued double-digit growth of our patient base. Additionally, we established a program to support home administration of KALBITOR, a step that provides patients with additional flexibility and control, giving them the ability to manage an attack in the home environment with the support and attention of a trained healthcare professional.”

Third Quarter 2011 Financial Results

Total revenues for the third quarter ended September 30, 2011 were $10.1 million, as compared to $7.0 million for the same quarter in 2010. Revenues for the 2011 quarter increased due to KALBITOR net sales of $6.6 million, as compared to $2.6 million for the comparable period in 2010. Total revenues for the nine months ended September 30, 2011 were $40.2 million compared to $42.1 million for the comparable period in 2010, and included $15.9 million and $5.8 million of KALBITOR net sales in 2011 and 2010, respectively. The nine month 2011 revenues also included $12.2 million of revenue associated with the expanded Sigma-Tau partnership; and the 2010 revenues included $13.8 million of development and license fee revenue associated with Dyax’s agreement with Cubist Pharmaceuticals, and $9.8 million of revenue from the sale of rights to royalties and other payments related to the commercialization of Xyntha® by licensee Pfizer, Inc. Quarterly revenues are expected to fluctuate due to the timing and amounts of future milestone payments, the clinical activities of our collaborators and licensees, and the timing and completion of contractual commitments.


Cost of KALBITOR product sales for the third quarter of 2011 were $260,000, as compared to $119,000 for the comparable quarter in 2010. For the nine months ended September 30, 2011, cost of product sales were $781,000, as compared to $247,000 for the comparable period 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.

Research and development expenses for the third quarter of 2011 were $8.7 million, as compared to $7.9 million for the same quarter in 2010. For the nine months ended September 30, 2011, research and development expenses were $26.2 million, as compared to $23.7 million for the same period 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;
  • Clinical study for the use of ecallantide for the treatment of ACE inhibitor-induced angioedema;
  • Conducting research on Dyax's preclinical pipeline; and
  • Pass-through license fees paid by Dyax licensees under the Licensing and Funded Research Program.

Selling, general and administrative expenses for the third quarter of 2011 were $8.8 million, as compared to $7.7 million for the same quarter in 2010. For the nine months ended September 30, 2011, selling, general and administrative costs were $27.1 million, as compared to $24.6 million for the same period in 2010. The higher selling, general and administrative costs in 2011 were primarily due to expanded infrastructure to support KALBITOR commercial efforts.

For the quarter ended September 30, 2011, Dyax reported a net loss of $9.7 million or $0.10 per share, as compared to a net loss of $11.3 million or $0.11 per share for the comparable quarter in 2010. For the nine months ended September 30, 2011, Dyax reported a net loss of $21.1 million or $0.21 per share, as compared to $15.6 million or $0.17 per share for the comparable period in 2010.

As of September 30, 2011, Dyax had cash, cash equivalents, and investments totaling $48.4 million, exclusive of restricted cash and not including $3.0 million of cash proceeds due during 2011 from the expanded partnership with Sigma-Tau.


2011 and Long-Term Financial Guidance

Dyax is increasing its financial guidance for 2011, including the following projections:

  • 2011 top-line total revenue to be in the range of $50-52 million
  • 2011 top-line KALBITOR net sales in the range of $20-24 million are included in the total revenue projection and are now expected to be at the upper end of this range

Other financial guidance remains unchanged, including the following projections:

  • 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

This guidance excludes potential revenue from the treatment of ACE inhibitor-induced angioedema and ex-U.S. KALBITOR sales.

Webcast and Conference Call

       

Date:

      Thursday, October 27, 2011

Time:

5:00 p.m. ET

Telephone

Access: Domestic callers, dial 877-674-2415; reference the Dyax conference call

International callers, dial 708-290-1364

No passcode required.

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 27, 2011 and may be accessed by dialing 855-859-2056. International callers should dial 404-537-3406. The replay passcode for all callers is 16922683. 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, New Zealand, Latin America (excluding Mexico), the Caribbean, Taiwan, Singapore and South Korea. The Company is also exploring other potential indications for ecallantide, either alone or through partnerships, including drug-induced angioedema.

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 through the Licensing and Funded Research Program (LFRP), which has approximately 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 the prospects for 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: competition from now and existing treatments for HAE; KALBITOR may not gain broad 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 commercialized and generate royalties; changing requirements and costs associated with Dyax's 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 Nine Months Ended
September 30, September 30,
  2011     2010     2011     2010  
(In thousands, except share and per share data)
Revenues:
Product sales, net $ 6,597 $ 2,622 $ 15,888 $ 5,796
Development and license fee revenues $ 3,535   $ 4,329   $ 24,333   $ 36,345  
Total revenues, net $ 10,132   $ 6,951   $ 40,221   $ 42,141  
 
Costs and expenses:
Cost of product sales 260 119 781 247
Research and development expenses 8,659 7,940 26,238 23,743
Selling, general and administrative expenses 8,790 7,668 27,120 24,619
       
Total costs and expenses   17,709     15,727     54,139     48,609  
 
Loss from operations (7,577 ) (8,776 ) (13,918 ) (6,468 )
 
Other income (expense):
Interest and other income 382 123 544 198
Interest and other expense   (2,528 )   (2,601 )   (7,690 )   (9,291 )
Total other expense (2,146 ) (2,478 ) (7,146 ) (9,093 )
 
Net loss $ (9,723 ) $ (11,254 ) $ (21,064 ) $ (15,561 )
 
Basic and diluted net loss per share $ (0.10 ) $ (0.11 ) $ (0.21 ) $ (0.17 )
 
Shares used in computing basic and diluted net loss per share   98,748,086     98,401,835     98,720,137     91,502,187  
 
 
SELECTED CONSOLIDATED CONDENSED BALANCE SHEET INFORMATION
(Unaudited)
 
September 30, December 31,
  2011     2010  
(In thousands)

Assets

 
Cash, cash equivalents and short-term investments $ 48,374 $ 77,384
Accounts receivable, net 6,790 5,315
Inventory 6,859 1,696
Other current assets 2,977 3,248
Restricted cash 1,266 922
   
Total current assets   66,266     88,565  
 
Fixed assets and other non-current assets 2,626 2,600
Restricted cash 1,100 1,266
   
Total assets $ 69,992   $ 92,431  
 

Liabilities and Stockholders' Equity (Deficit)

 
Accounts payable and other current liabilities $ 12,044 $ 11,958
Deferred revenue 17,326 21,336
Note payable and other long-term debt 55,461 56,504
   
Total liabilities   84,831     89,798  
 
Common stock and additional paid-in capital 448,521 444,911
Accumulated deficit and other comprehensive income (463,360 ) (442,278 )
   
Total stockholders' equity (deficit)   (14,839 )   2,633  
   
Total liabilities and stockholders' equity (deficit) $ 69,992   $ 92,431  

CONTACT:
Dyax Corp.
George Migausky, 617-250-5733
Executive Vice President
and Chief Financial Officer
gmigausky@dyax.com