10-22-13 4:01 PM EDT | Email Article

Dyax Corp. (NASDAQ: DYAX) today announced financial results for the third quarter ended September 30, 2013. Dyax will host a webcast and conference call at 5:00 p.m. (ET) today to review financial results and provide updates regarding its key value drivers – the Hereditary Angioedema (HAE) business, including KALBITOR® (ecallantide) and DX-2930, and the Licensing and Funded Research Program (LFRP).

Recent highlights include:

  • Initiation of a Phase 1 study of DX-2930 to evaluate the safety and tolerability of a single subcutaneous administration of DX-2930, Dyax’s fully human monoclonal antibody inhibitor of plasma kallikrein, which is being developed for potential prophylactic use in HAE;
  • KALBITOR® net sales for the third quarter 2013, all of which were to distributors, increased over the second quarter 2013 to $10.8 million, after an estimated 14% reduction in KALBITOR units in the distributor channel inventory;
  • KALBITOR patient demand units (units sold by distributors to hospitals or patients) increased in the third quarter by an estimated 8% over the second quarter of 2013 and an estimated 11% over the third quarter of 2012;
  • Eli Lilly’s completion of a rolling Biologics License Application (BLA) in the U.S. and a marketing authorization application (MAA) in Europe in second-line advanced gastric cancer using ramucirumab, a monoclonal antibody in Dyax’s LFRP portfolio;
  • Completion of an equity financing in October 2013 which provided net proceeds of approximately $64.7 million;
  • Cash, cash equivalents and investments at September 30, 2013 totaled approximately $47.1 million; the pro-forma balance, inclusive of the net proceeds of the October equity financing, totaled approximately $111.8 million.

“Dyax saw a number of important milestones in the third quarter, including growth in the KALBITOR business and successful initiation of the clinical program for DX-2930, a wholly-owned product candidate currently in development for potential prophylactic use in HAE,” said Gustav Christensen, President and Chief Executive Officer of Dyax. “Additionally, there were a number of positive Phase 3 data readouts from LFRP candidates, as well as the completion of marketing applications in the U.S. and Europe for one of these candidates, ramucirumab, for second-line advanced gastric cancer.”

Mr. Christensen added: “Dyax is well positioned for growth and value creation with our KALBITOR business remaining profitable and cash flow positive, DX-2930 moving through the clinic, a maturing portfolio of LFRP candidates, and a stronger balance sheet after our recently completed equity financing.”

2013 Third Quarter Financial Results

Total revenues for the third quarter ended September 30, 2013 were $13.7 million, as compared to $13.1 million for the comparable quarter in 2012. These include KALBITOR net sales of $10.8 million for both the third quarter of 2013 and the third quarter of 2012.

Total revenues for the nine months ended September 30, 2013 were $37.1 million, compared to $38.6 million for the comparable period in 2012, and included $27.9 million and $28.0 million of KALBITOR net sales for the comparable periods in 2013 and 2012, respectively.

Dyax expects quarterly and annual revenues to continue to fluctuate due to the timing and amount of distributor demand, future milestone payments, the clinical activities of collaborators and licensees, and the timing and completion of contractual commitments.

Cost of product sales for KALBITOR for the third quarter of 2013 were $720,000, as compared to $493,000 for the comparable quarter in 2012. For the nine months ended September 30, 2013, cost of product sales were $2.0 million, as compared to $1.4 million for the comparable period in 2012. For the third quarter of 2013, KALBITOR net sales were from product manufactured following the FDA’s approval of KALBITOR for sale in the United States and, therefore, cost of product sales reflects the full manufacturing cost. Costs associated with manufacturing KALBITOR prior to FDA approval were expensed as research and development costs and, accordingly, are not included in cost of product sales during the 2012 and earlier 2013 quarters.

Research and development expenses at Dyax are primarily related to the following research and development initiatives: 1) development costs associated with DX-2930, a fully human monoclonal antibody inhibitor of plasma kallikrein; 2) KALBITOR medical support and post-marketing requirements; and 3) pass-through license fees paid by Dyax licensees under the LFRP.

Research and development expenses for the third quarter of 2013 were $8.1 million, as compared to $6.2 million for the comparable quarter in 2012. Increases in 2013 were primarily due to pass-through license fees paid by Dyax licensees under the LFRP. For the nine months ended September 30, 2013, research and development expenses were $23.2 million, as compared to $22.7 million for the same period in 2012.

Selling, general and administrative expenses were $8.5 million for the third quarter of 2013, as compared to $9.1 million for the comparable quarter in 2012. For the nine months ended September 30, 2013, selling, general and administrative costs were $29.8 million, as compared to $29.9 million for the same period in 2012.

For the quarter ended September 30, 2013, Dyax reported a net loss of $6.2 million or $0.06 per share attributable to common stockholders, as compared to a net loss of $5.2 million or $0.05 per share for the comparable quarter in 2012. For the nine months ended September 30, 2013, Dyax reported a net loss of $25.8 million or $0.25 per share attributable to common stockholders, as compared to a net loss of $24.4 million or $0.25 per share for the comparable period in 2012.

As of September 30, 2013, Dyax had cash, cash equivalents, and investments totaling $47.1 million, exclusive of restricted cash. Inclusive of the $64.7 million of net proceeds from the equity offering completed in October 2013, Dyax would have had cash, cash equivalents, and investments totaling $111.8 million, as of September 30, 2013.

Financial Guidance

Dyax has reiterated its previously disclosed financial guidance for 2013:

  • Top-line total revenue to be in the range of $53-58 million, including
    KALBITOR net sales of $40-44 million.

All revenue guidance is expected to be at the low end of these ranges.

Webcast and Conference Call

Date:

      Tuesday, October 22, 2013

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 October 27, 2013 and may be accessed by dialing 855-859-2056. International callers should dial 404-537-3406. The replay passcode for all callers is 74956940. The webcast will be archived on the Dyax website for an indefinite period of time.

About Dyax

Dyax is a fully integrated biopharmaceutical company focused on the discovery, development and commercialization of novel biotherapeutics for unmet medical needs. The Company's key value drivers are the KALBITOR® (ecallantide) business, DX-2930 and the Licensing and Funded Research Program (LFRP).

Dyax developed KALBITOR on its own and, since February 2010, has been selling it in the United States for the treatment of acute attacks of HAE in patients 16 years of age and older. Outside the United States, the Company has established partnerships to obtain regulatory approval and commercialize KALBITOR in certain markets and is evaluating opportunities in others.

The Company is developing products to expand its angioedema portfolio, including a therapeutic candidate, DX-2930, for the prophylactic treatment of HAE and a biomarker assay to identify plasma- kallikrein-mediated disorders. In August 2013, Dyax began a Phase 1 clinical study evaluating the safety and tolerability of single subcutaneous administration of DX-2930 in healthy subjects.

KALBITOR and DX-2930 were identified using Dyax's 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 LFRP. This program has provided the Company a portfolio of product candidates being developed by its licensees, which currently includes 13 revenue eligible product candidates in various stages of clinical development, including three in Phase 3 trials.

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 ramucirumab and other candidates in the LFRP portfolio, the prospects for continued clinical development of DX-2930 and projected revenues and KALBITOR net sales for 2013. 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 new and existing treatments for HAE; uncertainty whether KALBITOR will gain broader market acceptance; 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 of KALBITOR worldwide and in the development and any resulting 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 LFRP candidates and other licensed products; uncertainties 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 and KALBITOR are registered trademarks of Dyax Corp.

DYAX CORP.
SELECTED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
                   
Three Months Ended Nine Months Ended
September 30, September 30,
2013 2012 2013 2012
(In thousands, except share and per share data)
Revenues:
Product sales, net $ 10,772 $ 10,814 $ 27,927 $ 27,988
Development and license fee revenues $ 2,919   $ 2,287   $ 9,140   $ 10,632  
Total revenues, net $ 13,691   $ 13,101   $ 37,067   $ 38,620  
 
Costs and expenses:
Cost of product sales 720 493 1,991 1,447
Research and development expenses 8,105 6,158 23,226 22,664
Selling, general and administrative expenses 8,507 9,117 29,804 29,872
Restructuring costs - - - 1,440
       
Total costs and expenses   17,332     15,768     55,021     55,423  
 
Loss from operations (3,641 ) (2,667 ) (17,954 ) (16,803 )
 
Other income (expense):
Interest and other income 199 5 206 22
Interest and other expense   (2,746 )   (2,548 )   (8,065 )   (7,650 )
Total other expense (2,547 ) (2,543 ) (7,859 ) (7,628 )
 
Net loss $ (6,188 ) $ (5,210 ) $ (25,813 ) $ (24,431 )
 
Net loss attributable to common stockholders $ (6,188 ) $ (5,210 ) $ (25,813 ) $ (24,431 )
 
Net loss per share attributable to
common stockholders, basic and diluted $ (0.06 ) $ (0.05 ) $ (0.25 ) $ (0.25 )
 
Shares used in computing basic and diluted net loss
per share for common stockholders   109,731,276     99,069,928     104,821,199     98,896,984  
 

SELECTED CONSOLIDATED CONDENSED BALANCE SHEET INFORMATION

(Unaudited)

       

September 30,

December 31,

2013

2012

(In thousands)

Assets

 
Cash, cash equivalents and investments $ 47,143 $ 29,046
Accounts receivable, net 6,215 7,507
Inventory 8,664 9,989
Fixed assets 5,139 5,329
Restricted cash 1,100 1,100
Other assets 2,378 2,515
   
Total assets $ 70,639   $ 55,486  
 

Liabilities and Stockholders' Deficit

 
Accounts payable and other current liabilities $ 13,866 $ 13,146
Deferred revenue 10,470 11,851
Note payable and other long-term debt 81,933 78,992
Other long-term liabilities 3,172 3,057
   
Total liabilities   109,441     107,046  
 
Common and preferred stock and additional paid-in capital 493,194 454,620
Accumulated deficit and other comprehensive income (531,996 ) (506,180 )
   
Total stockholders' deficit   (38,802 )   (51,560 )
   
Total liabilities and stockholders' deficit $ 70,639   $ 55,486  
 

Add a Comment

News   More...

Start Premium Trial Register For Free

P F Fund Financial Data (13,000+ funds)
P F Stock Financial Data (7,000+ stocks)
P F Stock and Fund Screeners (basic)
P F Investing Articles and Market Commentary
P F Articles Archive (>30 days)
P F Discuss (dozens of stock, fund, bond, and general bulletin boards)
P F Portfolio Manager (basic)
P F Morningstar Investment Classroom
P F Access Your Portfolio Anytime, Anywhere via Your Mobile Device
P   Morningstar Fund Analyst Reports (full research on 1,700 funds, ETFs, and CEFs)
P   Morningstar Stock Analyst Reports (full research on more than 1,100 stocks)
P   Portfolio Manager (advanced with 10 X-Ray analyses, including recommendations)
P   Portfolio Monitor (monthly and on-demand personalized portfolio statements)
P   Morningstar Proprietary Stock Information (stock star ratings, buy/sell prices, economic moat ratings, and more)
P   Morningstar 5-Star Stock and Fund Favorites & Red Flags eNewsletters
P   Premium Stock and Fund Screeners (advanced with nearly infinite ways to find the best securities for you)
P   Discounts on Morningstar newsletters, books, seminars, and more

Sign-up to Morningstar


Basic Access

Articles and Videos
Morningstar video reports, articles, data, and tools. Dig into our lineup of e-newsletters and investing classroom courses outlining sensible strategies for maximizing your investments.
Morningstar Discuss
Follow the buzz on individual stocks or fund families. Plus, read the latest posts from Morningstar members and analysts.
Portfolio Manager
Track your investments and watch lists with our Portfolio Manager. Customize your view with our comprehensive stock, fund, and ETF data.

Access these features and more when you sign up for Free Membership.
Join Morningstar today. It's Free.

Unlimited Access

Analyst Research
Gather in-depth, actionable insight on over 3,700 stock and mutual funds covered by Morningstar analysts. View our mutual fund Analyst Reports favored by professionals, savvy experienced investors, and new investors researching options for retirement savings, college plans, or other investment needs.
Portfolio X-Ray®
Ensure your portfolio is positioned exactly how you want with Morningstar's X-Ray Interpreter and Stock Intersection tools. A Barron's "Best of the Web" award winner for five years running, X-Ray Interpreter goes under the hood of your portfolio to provide a useful allocation, sector, and geographic analysis. And you can discover how much of a stock you really own, individually and through mutual funds, with Stock Intersection.
Investment Picks
Find new 5-star stocks (greatly undervalued companies) to consider daily. Our 5-star stock rating is a proven winner, consistently beating benchmarks like the S&P 500. Plus, browse our Fund Analyst Picks and Stewardship Grades to find shareholder-friendly mutual funds that are poised for outperformance.
Portfolio Monitor
Get a clear view of your investments with personalized reports about your portfolio. Receive monthly statements and generate reports on-demand to help you stay on track to meet your investment goals.

Access these features and more when you sign up for Premium Membership.
Start your free 14-day trial today online
Your subscription may be tax deductible. Please contact your tax advisor.

Content Partners
Morningstar - - Dyax Corp. Announces Third Quarter 2013 Financial Results
Name |  Ticker |  Star Rating |  Market Cap |  Stock Type |  Sector |  Industry Star Rating |  Investment Style |  Total Assets |  Category |  Top Holdings |  Top Sectors |  Symbol |  Title Star Rating |  Category |  Total Assets |  Top Holdings |  Top Sectors |  Symbol |  Name Topic |  Sector |  Key Indicators |  User Interest |  Market Cap |  Industry Name |  Ticker |  Star Rating |  Market Cap |  Stock Type |  Sector |  Industry Star Rating |  Investment Style |  Total Assets |  Category |  Top Holdings |  Top Sectors |  Symbol / Ticker |  Title Star Rating |  Category |  Total Assets |  Symbol / Ticker |  Name Title |  Date |  Author |  Collection |  Popularity |  Interest Title |  Date |  Company |  Symbol |  Interest |  Popularity Title |  Date |  Company |  Symbol |  Interest |  Popularity Title |  Date |  Author |  Collection |  Interest |  Popularity

Previous: Dyax Corp. Announces Fourth Quarter and Full Year 2013 Financial Results  |  Next: Dyax Corp. to Host Fourth Quarter and Year End 2013 Earnings Call and Webcast