Cost would be my guess. Who in their right mind would write a patient a prescription for Otezla at approximately $2,048.00/month and $24,576.00/year, when they could send them down to Wal-Mart for an OTC topical treatment for approximately $20? Unless you have a medically severe case of the "I'm a dumbass" or a life-threatening bowl blockage and can't take a crap, Otezla probably isn't the best option for that patient. But hey, what do I know? Let's wait and hear from Celgene's spokesperson Mr. "I will just post some investor village BS and call everyone a bitter little fella" to chime in and give us the most accurate answer to your question.
Rating: BUY Target Price: $105.00 OTEZLA Approved in Psoriasis; Maintain BUY Rating and $105 PT n OTEZLA Approved in Psoriasis. As we expected, FDA approved OTEZLA in moderate-to-severe plaque psoriasis. This indication has a significantly larger market size than psoriatic arthritis, for which the drug is currently marketed. Because of OTEZLA's profile—improvements in moderate-to-severe plaque psoriasis in its Phase III program and its relatively benign side effect profile relative to biological agents—we expect that OTEZLA will become an important revenue generator for Celgene. n Timing is Everything. Because psoriasis represents a much larger patient population than psoriatic arthritis, and is easily diagnosed, we expect the drug to become a leading contender in the psoriasis market. We believe this in spite of its modest initial sales in psoriatic arthritis, which is more a function of self-imposed limited distribution (small number of special pharmacies) and establishing formulary positioning, than it is a testament to OTEZLA's reception, in our view. OTEZLA is also being tested in a variety of other indications such as Behcet's disease, rheumatoid arthritis, atopic dermatitis, and others, which we believe all offer additional upside potential to this franchise that we have not yet accounted for in our estimates. n We Like the Pipeline. We continue to like Celgene's product portfolio and believe that incremental growth from REVLIMID, ABRAXANE and POMALYST, are near-term drivers of valuation expansion, with additional indications expected over the next 24 months. Also, data from newly acquired GD-0301 in Crohn's disease are due out shortly, and REVLIMID data that could lead to new indications are also possible before year-end. n REVLIMID Patent Overhang an Opportunity. To some extent, we believe an overhang on Celgene shares continues to exist from the U.S. patent challenge for REVLIMID. A Markman hearing was held this past spring, and visibility on a trial could be forthcoming in early 2015. We think this patent challenge has created an overhang that could be an opportunity for investors. n Valuation. We continue to like shares of Celgene for the revenue and EPS growth opportunities and portfolio diversification. Our price target is $105, which is based on a P/E multiple of 21x our 2015 EPS forecast of $4.91. Summary Celgene’s portfolio diversification story is in full swing, with the approvals and launches of POMALYST and ABRAXANE in pancreatic cancer rather recent, and OTEZLA (apremilast) in the early stages of its launch in psoriatic arthritis, and its approval in psoriasis, the much larger indication. The company’s flagship product, REVLIMID, should maintain growth from new indications and increasing duration of treatment, but we believe it is the combination of EPS upside from new products and indications and a strong milestone calendar that should drive P/E multiple expansion. REVLIMID is the most significant component of the company’s top and bottom lines and the focus of great scrutiny, but revenue and earnings acceleration should come from new products and indications, and this is spread over multiple products, hence diminishing risk from any one single product. We have held the view that new sources of revenue, in their totality, could be meaningful to the company, and this has included the launch of POMALYST, new indications for ABRAXANE, and the approval for OTEZLA. With ABRAXANE moving to become a foundation of treatment for pancreatic cancer and POMALYST hitting the market globally, we are forecasting accelerating sales and EPS growth. Add to this mix OTEZLA, which is still in the process of being rolled out in psoriatic arthritis (went on the market in 2Q:14), and will now launch in psoriasis, and the future looks bright, in our view. Additionally, there is a high degree of operating leverage in the P&L, suggesting multiple levers to earnings growth.
Celgene (CELG-NASDAQ) Stock Rating: Outperform Industry Rating: Outperform September 24, 2014 OTEZLA Approval for PsO Should Support Upside to Estimates Event Celgene announced late yesterday that FDA has approved the company’s oral PDE4 inhibitor OTEZLA (apremilast) for the treatment of patients with moderate to severe plaque psoriasis for whom phototherapy or systemic therapy is appropriate. The approval was based on safety and efficacy data from ESTEEM 1 and 2, two large, randomized, placebo-controlled phase 3 studies (n=1250) conducted in adult patients with a diagnosis of moderate to severe plaque psoriasis for at least 12 months prior to screening, and who were also candidates for phototherapy and/or systemic therapy. In the ESTEEM studies, OTEZLA demonstrated significant and clinically meaningful improvements in plaque psoriasis as measured by PASI-75 response rate at week 16 (29%-33% vs. 5%-6% placebo), as well as clinical improvement as measured by sPGA scores of clear to almost clear. Recall that OTEZLA was approved in March 2014 by FDA for the treatment of adults with active psoriatic arthritis. A combined psoriatic arthritis/psoriasis Marketing Authorization Application (MAA) was filed in Europe in 4Q13. Impact & Analysis We are maintaining our Outperform rating on the shares of CELG following OTEZLA approval for psoriasis (PsO). Approval was expected although we continue to expect an upside surprise to commercial performance and ultimate peak sales. With an estimated 1.5M patients with moderate-severe plaque psoriasis in the US alone, we believe that oral administration and unparalleled safety will differentiate from anti-TNFs, like AMGNs ENBREL, and support broad adoption. We estimate OTEZLA peak sales at $2.14B and would ascribe an incremental NPV of ~$4/share to approval for PsO. Valuation & Recommendation Our $115 price target is based on 25x our 2016 non-GAAP EPS estimate of $6.00, discounted 20%. We maintain an Outperform rating on CELG.
UBS - clean label approval, safety differentiates....we see upside to 2015-2017 consensus First Read Celgene Corporation Thoughts on the Otezla Label in Psoriasis Conclusion: Otezla approved in psoriasis; updated label remains clean The FDA approved Otezla for moderate to severe plaque psoriasis, which was widely expected by today's PDUFA date given the positive data in the phase-3 ESTEEM 1 and 2 trials. Recall that Otezla was approved in psoriatic arthritis on March 21. The revised label, with front-line use in psoriasis added to the indications, is still clean and lacks warnings for infection and malignancy as seen with anti-TNF agents. Our long term bull thesis is that Otezla will take share from methotrexate (MTX) as a first choice agent. Safety is the differentiating factor, but physician feedback had been mixed Recall that earlier this year, we wrote about expert feedback on Otezla (see HERE for the note with our conference call slides). We heard mixed feedback from doctors, with some specialists thinking it doesn't fit between mild treatments and biologics while others see it as a good option pre-biologic, post-biologic, with the possibility to expand the specialty drug prescriber base in dermatology. Given the favorable tolerability and efficacy relative to MTX, which is still widely used as a first choice agent for treating psoriasis despite liver toxicity and other side effects, we expect increasing use of Otezla in place of MTX, as well as post-MTX and in biologic failures. Because it is an oral regimen and does not increase the risk of infection or malignancy, Otezla could be the preferred agent for patients who cannot be treated with biologics. Furthermore, we expect some plans to require patients fail Otezla prior to treatment with a biologic. Impact to our thesis: Supportive; we see upside to 2015-2017 consensus Today's approval was largely expected by investors. However, given the long duration and positioning in the treatment paradigm of Otezla, we believe there is real upside to consensus 2015-2018 sales. We model WW Otezla sales of $1.8bn in 2017, growing to $4.2bn by 2025. Valuation: Buy, $112 PT based on 21x 2015e EPS We see upside on the patent challenge resolution, pipeline, and upward revisions.
Citi comments on Otezla Novartis’ Secukinumab May Pose Some Degree of Risk To Celgene’s Otezla in Psoriatic Arthritis What’s New ─ This morning Novartis announced that secukinumab (AIN457) met the primary endpoint in two ph3 studies (FUTURE 1 and FUTURE 2) in psoriatic arthritis (PsA). Efficacy data not provided in the press release. Secukinumab Ph3 Design and Timelines ─ The FUTURE 1 and FUTURE 2 ph3 studies tested secukinumab vs placebo in nearly 4k moderate to severe PsA patients with inadequate response to NSAIDs, DMARDs and / or TNF therapy. Overall, this is a more severe patient population than the Otezla ph3 PsA studies in our view. Patients could have had up to 3 prior TNF therapies. The dosing was once weekly for the first 4 weeks followed by once monthly dosing starting at week 4. The primary endpoint of ACR20 response criteria and secondary endpoints included PASI75. Novartis plans to submit global regulatory applications in ’15 and we note approval for psoriasis is expected in late ’14/early ’15. Secukinumab is the first IL-17 inhibitor to have positive ph3 data for PsA. Our Take ─ We estimate that ~80% of Otezla patients come onto the drug from methotrexate, steroids, or are treatment naïve, however we estimate ~20% of patients are TNF failures. However, we note that Otezla demand/access metrics continue to be encouraging and this week’s label expansion into PsO bodes well for demand. We continue to have high conviction on Celgene and believe that the stock is undervalued and the stock remains one of our top picks in lg-cap given the several key value creating catalysts in the next 12 mos and >20% revs/EPS growth ’14-’17. Otezla Demand Metrics Favorable ─ Based on our recent discussions with Celgene, following the April launch of Otezla in PsA the duration of therapy was initially short as the drug was used in very advanced patients who failed several biologics, but as the drug moves up the duration of therapy should improve. For Q3:14 we model sales of $33.6m vs cons $29m. Otezla Doing Better Than Xeljanz and Stelara ─ Based on initial Rx data, Otezla is doing better than Xeljanz and Stelara (see fig 1 on page 2) and this is meaningful give the drug only has sales in PsA -a much smaller indication then PsO or RA. We currently estimate that 85% of Otezla prescriptions are written by rheumatologists and with the recent approval in psoriasis, the market should expand considerably into the larger dermatology segment. However the strong uptake as shown by TRx is very encouraging as access has been good. The approval in PsO should lead to a meaningful uptick in Rx over time
but, but, but…that can't be possible…I was not hired…and I am a biologics PRO!….this is not possible…a plan did not hit the pentagon, it was a missile….nothing landed in that PA field….we faked the moon landings….not possible!!!!…..signed, Mr. Little Fella
Celgene drug a winner ? yeah & folks in hell are praying for snow !! Novartis going to kick tail , now HEAR THIS .......Mark These Words . Celgene will be outta derm in 18 months or less . They will sell O or have contract sales force . Then Celgene will admit mistake & return to doing cancer , something it can be good at .
"mark your words?" We already did and you were wrong. When you didn't get a call back to be a DM, you said, "mark my words, Celgene will be out of the I&I business for next summer." You said that in November 2013. Come on little fella, come up with something more oblique, something less easy to track with your predictions and then maybe someone will follow you, other than mommy bringing your sandwich down to the basement.
"Some" may require failure of a biologic? Which major plan doesn't require failure? Tricare? That's not a formulary win, "little stock copy and paste penis". That's a given. Does Tricare allow a 90-day supply of Oshitzla?
the oncology reps laugh at the Otesla reps pretending they have anything to do with "outperform or neutral " buy recs or anything to do with its reputation otesla is a mediocre little pill with mild efficacy and it costs a boatload of money, who in their right mind would brag about it like it carries a company
