2019 First Quarter Business Highlights and Financial Results

Discussion in 'OPKO Renal' started by anonymous, Jun 11, 2019 at 10:42 PM.

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  1. anonymous

    anonymous Guest

    May 7, 2019

    OPKO Health Reports 2019 First Quarter Business Highlights and Financial Results Conference call begins today at 4:30 p.m.

    Eastern time MIAMI, May 07, 2019 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) reports business highlights and financial results for the three months ended March 31, 2019.

    Business Highlights

    RAYALDEE total prescriptions reported by IQVIA increased 121% in 1Q 2019 compared with 1Q 2018: Total prescriptions for the first three months of 2019 increased to over 10,400, compared with approximately 4,700 during the comparable period of 2018.

    RAYALDEE Marketing Authorization Applications filed by Vifor Fresenius accepted for review in several European countries: These applications request approval to market

    RAYALDEE for the treatment of secondary hyperparathyroidism (SHPT) in adult non-dialysis patients with chronic kidney disease (CKD).

    American Journal of Nephrology published article and editorial: A post hoc analysis of RAYALDEE pivotal trials was published in the March edition of the American Journal of Nephrology and provides the first prospective data demonstrating that the current clinical practice guideline target for serum total 25- hydroxyvitamin D (30 ng/ml) is too low to decrease elevated serum PTH levels in CKD patients. These data show that the correct target is at least 51 ng/mL, and possibly as high as 93 ng/mL, levels no competitive therapy can reliably attain. This analysis received a favorable review in a co-published editorial by prominent nephrology KOLs.

    OPK88003 topline results reported from Phase 2 diabetes and obesity trial: In the mITT patient population, which included all patients who had a single dose of drug and one post-baseline efficacy value, HbA1c decreased by -1.3% (p-value <0.0001) and body weight decreased by -4.4 Kg (p-value <0.0001) from baseline. In the Per Protocol patient population, which included patients who were treated for at least 26 weeks and were compliant with the protocol for the duration of the trial, HbA1c decreased by -1.47% (p-value <0.0001) and body weight decreased by -5.5 Kg (p-value <0.0001) from baseline. The safety profile was similar to that expected for the incretin class of drugs, with GI side effects such as nausea, vomiting and diarrhea mostly mild and occurring during the dose-escalation phase.

    4Kscore® utilization remained strong during 1Q 2019 with approximately 19,400 tests performed: With all required documentation nearly complete, the company plans to make a submission shortly to the FDA for approval or clearance. In addition, OPKO has submitted a request for Medicare coverage reconsideration to its Medicare Administrative Contractor.

    BioReference and its GeneDx subsidiary expand access to commercially insured lives: BioReference and GeneDx have been selected for inclusion in the UnitedHealthcare Preferred Lab Network beginning July 1, 2019. This was a comprehensive process that evaluated service standards, turnaround time, quality and accreditation. More than 300 laboratories were invited to apply; only 100 submitted applications due to the complexity of the requirements, and BioReference and GeneDx, along with five other laboratories, earned a place in the Preferred Lab Network. In addition, effective April 1, 2019, BioReference and GeneDx are now innetwork providers with Humana, which provides access to 11 million additional lives.

    Financial Highlights

    Consistent with financial guidance issued in February 2019, the net loss for the first quarter of 2019 was $80.8 million, compared with a net loss of $43.1 million for the comparable period of 2018.

    Consolidated revenues for the first quarter of 2019 were $222.5 million, compared with $254.9 million for the comparable period of 2018. During the 2019 quarter, revenue from services was $178.9 million, revenue from products was $25.3 million, including RAYALDEE net revenue of $5.8 million, and revenue from licensing and intellectual property was $18.3 million. The decrease in revenue from services principally reflect reimbursement headwinds from higher denial rates in the company’s esoteric testing lines of business.

    Operating expenses for the first quarter of 2019 of $297.8 million included continued investment in the company’s pharmaceutical pipeline, with R&D expense of $36.5 million, principally for pediatric trials with the hGH-CTP long-acting human growth hormone product.

    In February 2019 OPKO completed the sale of $200 million aggregate principal amount of 4.5% Convertible Senior Notes due 2025, as well as retired and repaid $28.8 million of its 2033 Convertible Notes.

    Cash

    Cash equivalents and marketable securities were $207.3 million as of March 31, 2019.
     

  2. anonymous

    anonymous Guest

    2018
    Q1 $ 3.7 million
    Q2 $ 4.8 million
    Q3 $ 5.5 million
    Q4 $ 6.0 million

    64 reps to make $6M in Q4.

    2019
    Q1 $5.8 million

    64 reps to make $5.8 in Q1...downward trend?? I wonder if the new comp plan is the reason?
     
  3. anonymous

    anonymous Guest

    2017 Earnings call
    • Consolidated revenues for the three months ended December 31, 2017 were $193.7 million compared to $275.5 million for the comparable period of 2016. During the three months ended December 31, 2017, revenue from services were negatively impacted by non-recurring reimbursement adjustments from commercial and federal payor programs of $73.3 million and by reduced sample volume of $9.3 million.Revenue from products included $9.1 million of revenue from RAYALDEE, including $6.2 million related to revenue previously deferred through September 30, 2017.
    2017 YTD Rayaldee revenue = $9.3 million for the year.

    2017 Q4 $2.9 million
     
  4. anonymous

    anonymous Guest

    2017
    Q4 $2.9 million with 34 reps

    2018

    Q1 $ 3.7 million
    Q2 $ 4.8 million
    Q3 $ 5.5 million
    Q4 $ 6.0 million with 64 reps

    2019
    Q1 $5.8 million with 64 reps
     
  5. anonymous

    anonymous Guest


    https://d1io3yog0oux5.cloudfront.net/_c8ed7dd4a5087a8c07ab550140fcda7f/opko/db/332/2603/pdf/OPK+Health+Investor+Presentation_March+2019.pdf

    Read page 11 - "No good options"
    Read page 14 - 80??

    "Total RAYALDEE prescriptions increased approximately 141% in 4Q18 compared to 4Q17, and 17% compared to 3Q18"


    More lies and not ONE word about NBRXS.
     
  6. anonymous

    anonymous Guest

    Very sad.
     
  7. anonymous

    anonymous Guest

    And these numbers include not one but TWO PRICE INCREASES. Pathetically sad!
     
  8. anonymous

    anonymous Guest

    Classic example of smoke and mirrors
     
  9. anonymous

    anonymous Guest

    Sales force expansion was and is a failed experiment. What did the new reps bring to this company?
     
  10. anonymous

    anonymous Guest

    STDs and Butt Plugs
     
  11. anonymous

    anonymous Guest

    Inexperience in nephrology
     
  12. anonymous

    anonymous Guest

    Major factors is Rayaldee is a new drug treating an unmet need. Combined with building a sales force from scratch. Now that Rayaldee is in almost all insurance formularies, the sales department is maturing and over 2,000 providers have issued scripts, we should start seeing good growth.
     
  13. anonymous

    anonymous Guest

    Dream on little kool aid drinker, dream on
     
  14. anonymous

    anonymous Guest

    Rayaldee is a drug for a need that doesn’t exist led by a boiled peanut stand operator.
     
  15. anonymous

    anonymous Guest


    no way jose.....the only growth you will see is on your palm
     
  16. anonymous

    anonymous Guest

    "Almost all insurance formularies"....what MMIT / Formulary app are you looking at? Are you confusing it with the generics?

    https://formularylookup.com/?__hssc=214756936.1.1561506433246&__hstc=214756936.ed9fd6549f07ca90034de832ff0f9d6a.1561506433245.1561506433245.1561506433245.1&__hsfp=770081927&hsCtaTracking=c7b712cc-d34a-4166-a670-86d831e903c1%7Cb83bef8b-3af8-43db-8018-4d9ddaf2d754

    https://formularylookup.com/?__hssc=214756936.1.1561506433246&__hstc=214756936.ed9fd6549f07ca90034de832ff0f9d6a.1561506433245.1561506433245.1561506433245.1&__hsfp=770081927&hsCtaTracking=c7b712cc-d34a-4166-a670-86d831e903c1%7Cb83bef8b-3af8-43db-8018-4d9ddaf2d754
     
  17. anonymous

    anonymous Guest

    Coverage and affordability are two separate concepts. Sure, your Medicare plan may indeed cover Rayaldee—after a labor intensive appeal, and at a $300 co-pay. The only way these pts get the drug is through 501c3’s like the Healthwell foundation ( that Dr. Cheapskate refuses to fund). It is disgusting that this $1300 month drug is dependent on funding from a non-profit to make it affordable to patients. Frost is a 80 something billionaire. Does he think he’s going to take every last penny to the grave?
     
  18. anonymous

    anonymous Guest

    Here is a “What if”

    What if Amgen and some of the other big phatmrma companies decided NOT to fund the foundations that opko milks? Bye, bye rayaldee