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OPKO Health's RAYALDEE Gets Approval in Canada to Treat CKD

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OPKO Health's RAYALDEE Gets Approval in Canada to Treat CKD

OPKO Health's (OPK) partner VFMCRP gets regulatory nod from Health Canada to market flagship RAYALDEE; benefits patients diagnosed with chronic kidney disease.

OPKO Health, Inc.’s OPK partner Vifor Fresenius Medical Care Renal Pharma (“VFMCRP”) recently received approval from Health Canada to market RAYALDEE in the country.

Following the announcement, the company’s shares climbed 4% to close at $6.29. In the past six months, shares of OPKO Health have rallied 40.7% against the industry’s decline of 19.2%.

The stock carries a Zacks Rank #3 (Hold).

Coming back to the news, this development will enable treatment of secondary hyperparathyroidism (“SHPT”) in adults with stage 3 or 4 chronic kidney disease (“CKD”) in Canada.

The Kidney Foundation of Canada states that about 4 million Canadians live with CKD, of which 3,000 Canadians succumb to it each year.

Thus, the latest regulatory approval will ensure that more patients have access to the benefits of OPKO Health’s flagship RAYALDEE.

RAYALDEE at a Glance

RAYALDEE is OPKO Health’s leading renal product in the U.S. market. Launched in 2016, it is the first and only product which received approval from the FDA for treating SHPT.

In the last reported quarter, the company recognized $3.7 million of revenues from the sale of RAYALDEE. Total RAYALDEE prescriptions skyrocketed 730% on a year-over-year basis and improved 38% from the sequential quarter’s tally.

Furthermore, OPKO Health invested $7.3 million in the RAYALDEE commercial organization in the first quarter.

Market Prospects

According to a Global Info Research study, the worldwide market for CKD is expected to see a CAGR of roughly 4.1% over the next five years, reaching $15800 million in 2023, from $12400 million in 2017.

Per an article by Mordor Intelligence, the global renal medical devices and services market is expected to see a CAGR of about 6% between 2018 and 2023. Increasing prevalence of diabetes and a growing aging population worldwide are driving the market.

The study further states that North America and Europe are likely to account for the largest share of the market. Hence, the latest development has been a timely and strategic one for OPKO Health.

Want More From the Industry?

Some top-ranked stocks from the Medical Instruments space are Integer Holdings Corporation ITGR, Abiomed, Inc. ABMD and Masimo Corporation MASI.

Integer Holdings has projected long-term earnings growth rate of 15%. The stock flaunts a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Abiomed has a long-term expected earnings growth rate of 27%. The stock carries a Zacks Rank #2 (Buy).

Masimo’s expected long-term earnings growth rate is 14.6%. The stock carries a Zacks Rank #2.

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