Align Expands with Invisalign

In line with its strategy to expand in international arena, Align Technology, Inc. (ALGN - Analyst Report) recently obtained a Product Registration Certificate from the Federal Service of Health Care and Social Development Control of the Russian Federation for commercialization of its Invisalign system in Russia. With this approval, Align can sell its key products Invisalign Full, Invisalign Lite, Invisalign Teen, and Vivera Retainers in Russia.

Align intends to commence the commercial launch of the product with Dental Couture, Ltd., its distribution partner for Europe, Middle East, and Africa (EMEA). The company will launch the product in Russia as well as the Middle East.

Align had already gone ahead with the commercialization activities for Invisalign in Turkey. Presently, Dental Couture has trained over 30 orthodontists in Russia and 200 doctors in Turkey, Dubai and Saudi Arabia.

The company is extremely optimistic about the long-term potential of the Invisalign system in key countries like Russia, Saudi Arabia and other untapped markets in the Middle East. Commercial launch is expected by the first quarter of 2012.

Align has undertaken several strategies to improve the adoption of Invisalign including product/technology development, extending clinical effectiveness, extension of the Invisalign brand and expansion in international markets. During the third quarter of fiscal 2011, cases shipped to international markets were 18,170 (representing 22.9% of total worldwide volume), an increase of 12% year over year and 8% sequentially.

Align has already made significant progress in Germany, France, Spain and Italy. The Asia-Pacific (APAC) and Latin American regions also continued to deliver strong volume growth. However, the widespread austerity measures in both public and private sectors led to a softer performance in the UK.

In the last reported quarter, the company successfully launched its Invisalign G3 in international markets including Europe, Asia Pacific, China and Japan. The company believes that the new features and functionality delivered with Invisalign G3 and G4 are even more effective outside North America, especially in Asia, due to the higher complexity of cases among the Asian population.

Over a long term, we expect G4 and similar other innovations to act as major catalysts for the continued growth momentum of Align in new as well as existing markets.The company also strengthened its sales force and added territory managers in targeted international markets.

In separate news, Align introduced its new Invisalign Express 5 which will provide low cost treatment options for minor dental problems like crowding, spacing and orthodontic relapse which require five or fewer stages of Invisalign aligners. January 30, 2012 onwards, Invisalign Express 5 will be available to Invisalign doctors in North America.

Banking on Invisalign, Align has established itself as a strong player in the malocclusion market across the globe. The company has also widened its portfolio to cater to a wider base of patients which is encouraging. We remain hopeful based on the company’s key new generation product Invisalign G4. Align currently retains a Zacks #2 Rank (short-term Buy rating).

However, current economic uncertainty continues to cast a negative impact on dental procedures because of its elective nature. Moreover, the company faces significant competition from players such as 3M (MMM - Analyst Report), Danaher Corporation (DHR - Analyst Report) and Dentsply International (XRAY - Analyst Report).

argins are under pressure due to Align’s strategic investments in the international market, portfolio expansion, purchase of a new manufacturing facility in Juarez, Mexico and higher operating costs associated with the acquisition of Cadent.

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