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OPKO Health (OPK) and Nicoya Sign RAYALDEE Deal

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OPKO Health, Inc. (OPK - Free Report) recently announced that its subsidiary EirGen Pharma has inked a deal with Nicoya Macau Limited, an affiliate of Nicoya Therapeutics (Nicoya), for the development and commercialization of RAYALDEE in Greater China. RAYALDEE is used to treat secondary hyperparathyroidism (SHPT) in stage 3 or 4 chronic kidney disease (CKD) patients. This agreement is expected to bring the innovative solution to patients across mainland China, Hong Kong, Macau and Taiwan.

The collaboration is intended to utilize Nicoya’s expertise and established network to enable RAYALDEE to penetrate the growing market in China with significant unmet medical need related to kidney health. Per the company data, China is said to have an estimated 19 million people suffering from stage 3 or 4 CKD.

Financial Terms of the Deal

Under the agreement, OPKO Health is set to receive an upfront payment of $5 million from Nicoya. An additional $5-million payment will be made in the first 12 months of the agreement or upon Nicoya achieving a certain predetermined development milestone. OPKO Health is also entitled to tiered, double-digit royalties on product sales and up to $115 million upon attainment of certain milestones. Regulatory approvals and commercial activities relating to RAYALDEE in Greater China will be handled by Nicoya.

Few Words on RAYALDEE

RAYALDEE is an extended-release formulation of calcifediol, a prohormone of calcitriol, the active form of vitamin D3. It is the only drug to get FDA approval for sufficiently raising serum total 25-hydroxyvitamin D to effectively lower blood levels of intact parathyroid hormone.

Industry Prospects

Per a report published in Research and Markets, the global Chronic Kidney Disease Drugs market is expected to see a CAGR of 3.9% from 2017 to 2025. Factors like increasing prevalence of CKD, greater incidence of cardiovascular disorders and diabetes, growing geriatric population, promising pipeline molecule, favorable reimbursement policies in some countries and increased R&D activity in the development of CKD drugs given high unmet needs are fueling market growth globally.

 

Zacks Investment Research

Image Source: Zacks Investment Research

 

Given the market prospects, OPKO Health’s recent agreement with Nicoya seems well-timed.

Notable Developments

In June 2021, BioReference Laboratories, Inc., an OPKO Health company, partnered with Royal Caribbean Group to provide COVID-19 testing for their U.S.-based crew and guests. Under the agreement, unvaccinated guests will be required to undergo rapid, point-of-care PCR COVID-19 tests before embarking on the cruise, at the end of their travel and also during the cruise depending on voyage length. The crew members on board will undergo routine laboratory-based PCR tests at regular intervals.

In the same month, OPKO Health’s subsidiary EirGen Pharma, Ltd. entered into a definitive agreement with Horizon Therapeutics plc to divest one of its facilities in Waterford, Ireland, which houses EirGen’s sterile-fill-finish business. This sell-off is expected to expand focus on EirGen’s oral solid dose products business while strengthening OPKO Health’s balance sheet, reducing expenses and improving efficiency.

In May 2021, the company announced the transfer of licensed rights to RAYALDEE from Japan Tobacco Inc. (JT) to Vifor Fresenius Medical Care Renal Pharma (VFMCRP) following JT’s decision to terminate its exclusive agreement with EirGen Pharma concerning the development and commercialization of RAYALDEE in Japan. This transfer to VFMCRP will facilitate the development and commercialization of the drug in Europe and other international markets.

Share Price Performance

The stock has outperformed its industry over the past year. It has grown 30.8% compared to the industry’s growth of 25.2%.

Zacks Rank and Key Picks

Currently, OPKO Health carries a Zacks Rank #3 (Hold).

A few better-ranked stocks from the broader medical space include PetIQ, Inc. (PETQ - Free Report) , National Vision Holdings, Inc. (EYE - Free Report) and Envista Holdings Corporation (NVST - Free Report) .

PetIQ, currently sporting a Zacks Rank #1 (Strong Buy), has a long-term earnings growth rate of 25.00%. You can see the complete list of today’s Zacks #1 Rank stocks here.

National Vision Holdings, which carries a Zacks Rank #1, has a long-term earnings growth rate of 23.00%.

Envista Holdings, which carries a Zacks Rank #2 (Buy), has a long-term earnings growth rate of 26.40%.

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