UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C.  20549

FORM 8-K


CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported):  July 29, 2015


DYAX CORP.
(Exact Name of Registrant as Specified in Charter)

Delaware

000-24537

04-3053198

(State or Other Jurisdiction of

Incorporation)

(Commission File Number)

 

(IRS Employer Identification No.)

 

55 Network Drive
Burlington, MA  01803

(Address of Principal Executive Offices) (Zip Code)


(617) 225-2500
(Registrant’s telephone number, including area code)

Not Applicable
(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))


Item 2.02.

Results of Operations and Financial Condition.

On July 29, 2015, Dyax Corp. issued a press release announcing its financial results for the quarter ended June 30, 2015.  Pursuant to Item 2.02, a copy of the press release is hereby furnished to the Commission as Exhibit 99.1 to this report and is incorporated by reference herein.

Item 9.01.

Financial Statements and Exhibits.

 

(d)

Exhibits.

 

99.1

 

Press release of Dyax Corp. dated July 29, 2015 reporting Dyax’s financial results for the quarter ended June 30, 2015.


SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

DYAX CORP.

 
 

Dated:

July 29, 2015 By:

/s/ Gustav Christensen

Gustav Christensen

Chief Executive Officer and President


EXHIBIT INDEX

Exhibit
No.

 

Description

 

99.1

Press release of Dyax Corp. dated July 29, 2015 reporting Dyax’s financial results for the quarter ended June 30, 2015.



Exhibit 99.1

Dyax Corp. Announces Second Quarter 2015 Financial Results

BURLINGTON, Mass.--(BUSINESS WIRE)--July 29, 2015--Dyax Corp. (NASDAQ: DYAX) today announced financial results for the second quarter ended June 30, 2015. Dyax will host a webcast and conference call at 5:00 p.m. (ET) today to review financial results and provide updates on DX-2930, KALBITOR® (ecallantide) and the Licensing and Funded Research Portfolio (LFRP). The Company will also provide an introductory overview of its internal development candidates.

Recent highlights include:

  • Receipt of Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the investigation of DX-2930 for hereditary angioedema (HAE);
  • Total revenue for the second quarter of 2015 of $26.4 million, including:
    • KALBITOR net sales of $17.8 million and
    • Royalty revenue of $4.4 million, as well as
  • Cash, cash equivalents and investments at June 30, 2015 totaled $394.2 million.

2015 Second Quarter Financial Results

Total revenues for the quarter ended June 30, 2015 were $26.4 million, as compared to $19.6 million for the comparable quarter in 2014. The second quarter 2015 revenues included $17.8 million of KALBITOR net sales, as compared to $16.6 million for the same period in 2014, as well as royalties of approximately $4.4 million based on sales of Eli Lilly and Company’s CYRAMZA® (ramucirumab). For the six months ended June 30, 2015, total revenues were $46.8 million, compared to $33.7 million for the same period in 2014. The six-month 2015 revenues included $33.8 million of KALBITOR net sales, as compared to $29.1 million in the 2014 period, as well as CYRAMZA royalties of approximately $7.8 million. The third quarter of 2014 was the first period in which we recorded royalty revenue.

Dyax expects quarterly and annual revenues to fluctuate. For KALBITOR, revenue fluctuations are primarily due to variability in the rate at which individual patients utilize KALBITOR to treat attacks (particularly among patients who experience and treat frequent attacks), as well as the timing and amount of distributor demand. For the LFRP, revenue fluctuations may be caused by the timing of any future milestone payments, the clinical activities of our licensees, and the timing and completion of contractual commitments.


Cost of product sales for KALBITOR for the second quarter of 2015 were $1.4 million, as compared to $975,000 for the same quarter in 2014. For the six months ended June 30, 2015, cost of product sales were $3.5 million, as compared to $1.8 million for the same period in 2014.

Cost of royalties for the second quarter of 2015 were $2.2 million, consisting of pass-through fees under an LFRP cross-licensing arrangement. For the six months ended June 30, 2015, cost of royalties were $3.9 million.

Research and development expenses at Dyax are primarily related to the following: 1) the DX-2930 development program, together with other research programs; 2) KALBITOR medical support and post-marketing requirements; and 3) pass-through license fees paid by Dyax under the LFRP. Research and development expenses for the second quarter of 2015 were $14.5 million, as compared to $8.5 million for the same quarter in 2014. For the six months ended June 30, 2015, research and development expenses were $24.8 million, as compared to $15.3 million for the same period in 2014. The 2015 increases are primarily related to costs associated with DX-2930 development.

Selling, general and administrative expenses were $14.2 million for the second quarter of 2015, as compared to $10.6 million for the same quarter in 2014. For the six months ended June 30, 2015, selling, general and administrative costs were $25.2 million, as compared to $20.1 million for the same period in 2014. The higher selling, general and administrative costs in 2015 were due to increased charges for non-cash stock compensation expense, as well as increased sales and marketing costs supporting KALBITOR commercial efforts.

For the quarter ended June 30, 2015, Dyax reported a net loss of $8.4 million or $0.06 per share attributable to common stockholders, as compared to a net loss of $3.1 million or $0.02 per share for the same quarter in 2014. For the six months ended June 30, 2015, Dyax reported a net loss of $15.7 million or $0.11 per share attributable to common stockholders, as compared to a net loss of $8.8 million or $0.07 per share for the same period in 2014.

As of June 30, 2015, Dyax had cash, cash equivalents, and investments totaling $394.2 million, exclusive of restricted cash.

Financial Guidance

Dyax has reiterated its revenue guidance for 2015. Revenue guidance includes two components:

  • KALBITOR net sales in the range of $60-70 million.
  • Development and license fees in the range of $7-9 million. These fees exclude all potential royalties which would be earned from licensees' sales of LFRP product.

The Company has revised its operating costs and expenses (cost of product sales, research and development expenses, and selling, general and administrative costs) which are expected to be in the range of $120-125 million, an increase from its previous guidance of $105-110 million. This increase is due to costs associated with the acceleration of the DX-2930 development program and non-cash stock compensation charges.

 

Webcast and Conference Call

Date:

        Wednesday, July 29, 2015

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 (http://investor.dyax.com/events.cfm) and follow instructions for accessing the live webcast. Participants may register in advance. The webcast will be archived on the Dyax website for an indefinite period of time.

 

About Dyax

Dyax is a biopharmaceutical company focused on the development and commercialization of novel biotherapeutics for unmet medical needs. The Company is developing DX-2930, a fully human monoclonal antibody, for the prevention of HAE attacks. In March 2015, the Company reported positive safety, pharmacokinetic, biomarker and proof-of-concept efficacy results from its Phase 1b clinical trial of DX-2930 in HAE patients. DX-2930 has received Fast Track and Breakthrough Therapy designations from the FDA. Additionally, Dyax markets KALBITOR® (ecallantide) for the treatment of acute attacks of HAE in patients 12 years of age and older.

Both DX-2930 and KALBITOR were identified using Dyax's proprietary phage display technology. Dyax has broadly licensed this technology under its Licensing and Funded Research Portfolio (LFRP). The current portfolio includes one FDA approved product, Eli Lilly and Company’s CYRAMZA (ramucirumab), for which Dyax receives royalties, and multiple product candidates in various stages of clinical development for which the Company is eligible to receive future milestones and royalties.

For additional information about Dyax, please visit www.dyax.com.

For additional information about KALBITOR, including full prescribing information, please visit www.KALBITOR.com.


Disclaimer

This press release contains forward-looking statements, including statements regarding the prospects for cash flow from KALBITOR and the LFRP; and financial guidance for projected revenues, KALBITOR net sales and operating costs and expenses for 2015. 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: competition from new and existing treatments for HAE; uncertainty regarding KALBITOR's market share; uncertainty regarding treatment rates for patients on KALBITOR and distributor channel inventory levels; Dyax's dependence on the expertise, effort, priorities and contractual obligations of third parties in the manufacture, quality control and storage of KALBITOR; Dyax's dependence on the expertise, effort, priorities and contractual obligations of licensees and collaborators for development, clinical trials, manufacturing, sales and distribution of product candidates in the LFRP; uncertainties as to whether and when new product candidates in the LFRP will achieve development and regulatory milestones and 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 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 and KALBITOR are registered trademarks of Dyax Corp.

CYRAMZA is a trademark owned by or licensed to Eli Lilly and Company, its subsidiaries, or affiliates.

- financial tables follow -


               
DYAX CORP.
SELECTED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
 
Three Months Ended Six Months Ended
June 30, June 30,
  2015     2014     2015     2014  
(In thousands, except share and per share data)
Revenues:
Product sales, net $ 17,760 $ 16,582 $ 33,773 $ 29,089
Development and license fees 4,228 3,003 5,260 4,613
Royalty revenue 4,385 - 7,758 -
       
Total revenues, net $ 26,373   $ 19,585   $ 46,791   $ 33,702  
 
Costs and expenses:
Cost of product sales 1,423 975 3,519 1,760
Cost of royalty revenues 2,192 - 3,879 -
Research and development 14,510 8,456 24,752 15,325
Selling, general and administrative 14,153 10,565 25,194 20,054
       
Total costs and expenses   32,278     19,996     57,344     37,139  
 
Loss from operations (5,905 ) (411 ) (10,553 ) (3,437 )
 
Other income (expense):
Interest and other income 203 73 291 111
Interest and other expense   (2,709 )   (2,723 )   (5,420 )   (5,446 )
Total other expense (2,506 ) (2,650 ) (5,129 ) (5,335 )
 
Net loss $ (8,411 ) $ (3,061 ) $ (15,682 ) $ (8,772 )
 
Basic and diluted net loss per share $ (0.06 ) $ (0.02 ) $ (0.11 ) $ (0.07 )
 
 
Shares used in computing basic and diluted net loss per share   144,703,202     135,873,613     140,791,906     130,277,157  
 
           

SELECTED CONSOLIDATED CONDENSED BALANCE SHEET INFORMATION
(Unaudited)

 

June 30,

December 31,

2015

2014

(In thousands)

Assets

 
Cash, cash equivalents and investments $ 394,157 $ 184,652
Accounts receivable, net 10,938 12,221
Inventory 11,352 7,228
Fixed assets 5,158 4,631
Restricted cash 1,100 1,100
Other assets 5,035 7,301
   
Total assets $ 427,740   $ 217,133  
 

Liabilities and Stockholders' Equity

 
Accounts payable and other current liabilities $ 18,207 $ 18,532
Deferred revenue 7,398 7,574
Note payable and other long-term debt 82,111 82,165
Other long-term liabilities 2,863 3,059
   
Total liabilities   110,579     111,330  
 
Common and preferred stock and additional paid-in capital 878,660 651,616
Accumulated deficit and other comprehensive income (561,499 ) (545,813 )
   
Total stockholders' equity   317,161     105,803  
   
Total liabilities and stockholders' equity $ 427,740   $ 217,133  
 

CONTACT:
Dyax Corp.
Jennifer Robinson, 617-250-5741
Director, Investor Relations
and Corporate Communications
jrobinson@dyax.com

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