Dyax (NASDAQ: DYAX), a developer of the phage display technology, is focused on discovering innovative therapies for unmet medical needs. At the same time, the company is also focused on enhancing value for stockholders. Given the company's product portfolio and the performance of its shares so far this year, it is certainly delivering on both fronts.
Shares up more than 100%
Dyax shares have gained more than 100% so far this year. The gains have come as Dyax continues to make strong progress on the operating front. Most recently, Dyax announced the dosing of the first subject in a phase 1 trial of DX-2930 for prevention of hereditary angioedema, or HAE, a rare complex disease affecting an estimated one in 10,000 to one in 50,000 people worldwide.
Kalbitor, the company's lead product candidate, has already been approved by the Food and Drug Administration for the treatment of acute attacks of HAE in patients 16 and older. While the company has been selling Kalbitor in the U.S. since February 2010, it has established several partnerships outside the U.S. to commercialize the product.
This year, the company announced a strategic partnership with CVie Therapeutics for the development and commercialization of Kalbitor for the treatment of HAE and other angioedema indications in China, Hong Kong, and Macau. In January, the company entered into a strategic partnership with Novellus Biopharma to develop and commercialize Kalbitor in Latin America. The progress that Dyax is making with commercializing Kalbitor is one of the major reasons for this year's rally. Another reason is the significant potential in the HAE treatment market.
HAE treatment market
There is an urgent need for therapies to treat HAE. There are currently only five approved drugs for the treatment of HAE. This market was valued at $113.8 million in 2011, according to Global Data. However, it is expected to grow at a compound annual growth rate of 16.5% over the next few years to reach $385 million by 2019.
Apart from Kalbitor, the other approved drugs to treat HAE are Firazyr from Shire (NASDAQ: SHPG), Cineryze from ViroPharma (NASDAQ: VPHM), Berinert IV injection from CSL Limited, and Ruconest.
Shire's Firazyr is used as a treatment for acute attacks of HAE in patients 18 and older. The SC injection can be used as and when symptoms of HAE arise. Firazyr sales totaled $49.5 million in the second quarter of 2013, representing an increase of 56% over the same period the previous year. The increase was driven by continued growth in global treatment market for HAE.
ViroPharma's Cineryze has been developed in collaboration with Halozyme. It has been approved for the prevention and treatment of HAE in the U.S. and Europe. In the second quarter of 2013, Cineryze net sales totaled $91 million, representing an increase of 22% over the second quarter of 2012.
Normalizing Kalbitor sales
Dyax's Kalbitor registered sales of $8.3 million in the second quarter of 2013. CEO Gustav Christensen noted that in the second quarter, the Kalbitor business returned to more normalized treatment rates, as confirmed by a rebound in patient demand unit growth. Kalbitor patient demand units rose by an estimated 17% in the second quarter. Some of the recent gains in Dyax shares can be attributed to normalizing sales for Kalbitor. More importantly, Christensen noted that the Kalbitor business remains cash flow positive and continues to support the growth of the company's evolving internal pipeline. For 2013, Kalbitor sales are expected to be between $40 million and $44 million.
Additional clinical programs
Indeed, Kalbitor is helping Dyax expand its angioedema portfolio. The company is currently developing treatments for patients who experience plasma kallikrein (bradykinin) mediated angioedema.
In addition, under the Licensing and Funded Research Program, the company has entered into a number of licensing agreements and collaborations. Through the LFRP, the company provides access to its phage display technology. Currently, the company has more than 70 licensing agreements and collaborations with different research, biotechnology, and pharmaceutical companies.
Why Dyax is a compelling investment
Dyax is continuing to advance its clinical programs. Kalbitor has been doing reasonably well, and given the expected growth in the HAE treatment market, the lead product has significant potential going forward.
Dyax also has a robust cash position, which will help the company in advancing its product portfolio. But, most importantly, the company has a unique technology in phage display.
While Dyax shares have posted significant gains so far this year, the above factors suggest that the stock still has room to grow.