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Exelixis, Inc. (EXEL)

NasdaqGS - NasdaqGS Real Time Price. Currency in USD
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17.32+0.29 (+1.70%)
At close: 04:00PM EST
17.32 0.00 (0.00%)
After hours: 07:59PM EST
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  • J
    J
    Exelixis has generated $0.51 earnings per share over the last year ($0.51 diluted earnings per share) and currently has a price-to-earnings ratio of 33.9. Earnings for Exelixis are expected to grow by 46.00% in the coming year, from $0.50 to $0.73 per share.
  • R
    RJ
    Data was good in the Cosmic-021 cohort. The disease control rate (DCR; complete response + partial response + stable disease) was 71%. Median progression-free survival (PFS) was 3.0 months (95% confidence interval [CI]: 2.7-5.4), and median overall survival (OS) was 14.0 months (95% CI: 5.5-16.7). Median duration of response was 7.6 months (95% CI: 4.2-not estimable [NE]).

    CAMILLA trial data was also good. The primary outcome of investigator-assessed ORR per modified RECIST version 1.1 was 27.6%. The confirmed partial response rate was 20.7%, and the DCR was 86.2%. Median PFS was 3.8 months (95% CI: 3.4-6.3), with a 6-month PFS of 34.5% (95% CI: 17.9-54.3). Median OS was 9.1 months (95% CI: 5.8-21.8). In a subgroup analysis of those with wild-type RAS (n=12), ORR was 50.0%, and DCR was 83.3%. Median PFS was 6.3 months (95% CI: 1.8-NE), and median OS was 21.8 months (95% CI: 4.5-NE).
  • J
    J
    Piper Sandler Raises Exelixis FY2022 Earnings Estimates to $0.91 EPS (Previously $0.62).
  • E
    Expert
    Exelixis is 1 negative study away from being in low teens . This study that will be reported in the 2nd quarter of this year is Cosmic -313 - triplet of nivo/ipi/ Cabo vas nivo/ipi in 1st line RCC. This study needs to show overall survival advantage to move the needle in RCC since triplet toxicity and cost is very high . In my opinion chance of hitting OS is extremely low , 10-% at most . It will no doubt improve PFS but with multiple options for 2nd , 3rd and even later lines of active therapy that the control group will have access to It is a very high bar . Also design focuses on intermediate and poor risk category patients where nivo/ ipi doublet already shines so it’s going to be very difficult for concurrent Cabo to add OS benefit . So don’t hold your breath folks and enjoy 17 $ PPS, it won’t last too long since I believe few $s is baked into the idea this study will be positive and will expand 1st line RCC Cabo penetration . Sorry to say it but it’s extremely unlikely
  • J
    J
    Volume today 3,632,978
    Avg. Volume 1,939,027
    Since when is this not significantly higher volume than average?
  • J
    J
    Michael King from H.C. Wainwright reiterated a Buy rating on Exelixis with a price target of $52.00.
  • M
    Mitchell
    I thought the results were good but not great. I have been a nurse for 35 years and have been investing in biotech stocks for 25. I can read and understand clinical data.

    The results are good enough to continue onto to phase 3. I think approval can be expected but these results are not compelling enough for oncologists to prescribe the combo enough to improve our bottom line much.

    Phase 3 needs to be a bit better. We need a survival rate of 18 months.

    This is a competitive space and I'm proud of this company working hard to meet these needs and help buy these patients time. We have a solid scientific team with MMM, Lamb and Goodman.
    Bullish
  • T
    Tam
    Thank you JBWIN for sharing.

    Key takeaways:

    1) First full Qtr after the approval of "Clear" Pem/Len. with TRx increased of +4% Q/Q for the total of 36% market share. Given continued market share growth, the fear of competition was overblown. Toxicity for "Clear" might scare away some physicians

    2) Price increased of 7.5% eff. Jan 1, 22. (~$97.5M to the bottom line)

    3) Could be an attractive takeout target due to (1) having several approved products; (2) offering tremendous growth prospects; (3) fully scaled out infrastructure; (4) with sustainable profitability; and (5) trading at attractive valuation.

    Cowen - EXEL: Q4 CABO REVS INLINE, GUIDANCE SHOWS OPTIMISM FOR CONTINUED SHARE GAIN IN 1L RCC (Outperform PT 24)

    Prelim Q4 report shows in-line product revs ($300M vs Cons $296M/Cowen $282M) and FY22 sales guidance of +23-32% y/y growth shows optimism for market share gains in 1L RCC. FY22 guidance is in line with consensus expectations (Cowen $1.38B and Cons $1.35B), and stock performance will pivot on data updates from COSMIC-313 and early pipeline, and outcome of ANDA court case in May.

    Our Take: Cabo Continues To Gain Share On Back of 9ER Momentum — Q4 Provided Key Read As First Full Quarter After Lenvima Approval

    Based on the preliminary Q4 earnings, cabo market share built on the momentum that
    has been ongoing since Q4:20 as physicians began adoption of 9ER in 1L RCC ahead of approval (approved Jan. ’21). According to IQVIA, Q4 Cabo TRx volume was +4% q/q, which represents 36% TRx market share for cabo (up from 33% in Q3). Of note, the +13% q/q growth in Q4 for Cabo is on back of more modest +4% TRx q/q growth, suggesting potential inventory stocking ahead of the new year (especially given the 7.5% price increase for Cabo effective 1/1/22) and bounce back after sluggish oral RCC drug market Q3.

    We believe Q4 was an important barometer for cabo sales into FY22 as it represents the first full quarter after the approval for Merck’s Lenvima (approved in combination with Keytruda in 1L RCC in Aug. ’21). Thus, given the continued market share growth for Cabo in Q4, we believe concerns about Lenvima competition may have been overdone. Our KOLs have been impressed by the data for Lenvima + Keytruda in the CLEAR study and expected it to be a tough competitor in 1L, though they noted that toxicity concerns could hamper adoption.

    The outlook ahead will very much be determined by key data updates (both Cabo and early stage pipeline) and outcome of ANDA litigation now that the trial has been scheduled for May ’22.

    Exelixis Will Have Key Data Updates in FY22

    We believe the next leg of where the 1L RCC market can go will depend on whether triple therapy has the best chance of optimizing survival. The COSMIC-313 trial is testing cabo/ Opdivo/Yervoy in 1L RCC and enrollment (n=840) was completed in March ‘21 with data expected in H1:22. The final Phase 1 expansion results for the triplet combo at ASCO GU ‘21 confirmed the activity seen in the dose escalation portion of the study and demonstrate a safety profile that was similar to the doublet combo of cabo/Opdivo. The lack of significant added toxicity with the addition of Yervoy in Phase 1 bodes well for COSMIC-313 as it will be key for the triplet to be tolerable enough to be used in community settings without significant dropouts.

    Our consultants expect the triplet to surpass the doublet on PFS, but key question is whether the magnitude of the difference will be sufficient to also drive an OS benefit (which is admittedly hard in 1L setting). This is important to justify moving all 3 drugs to be used together in 1L instead of sequencing the regimens to maximize outcomes.


    Our Investment Thesis

    After strong growth, Cabometyx (cabozantinib) is facing intense competition that may pressure sales. Positive Phase 3 data from CHECKMATE-9ER (Opdivo/cabo) in 1L RCC has re-accelerated growth. Over the long term, we see cabo being used across all RCC patients, thereby maintaining its value. We expect the pipeline to provide long-term growth and are optimistic for success. We think Exelixis could be an attractive takeout target due to (1) having several approved products; (2) offering tremendous growth prospects; (3) fully scaled out infrastructure; (4) with sustainable profitability; and (5) trading at attractive valuation.

    Forthcoming Catalysts

    ■ Potential sNDA filing for cabo in 1L HCC (Early '22)

    ■ Cabo data from COSMIC-313 in 1L RCC (H1:22)

    ■ Initiate Ph1 for XL114 in non-Hodgkin's lymphoma (H1:22)

    ■ Initial Ph1 data for XL102 in advanced solid tumors (2022)

    ■ Initial Ph1 data for XB002 in advanced solid tumors (2022)
  • J
    J
    Oppenheimer, RBC, Cowan, William Blair etc. all have verifiable credentials and are on financial programs, they are companies that are trusted and paid a lot of money for guidance.
    There is no way to verify people such as Expert etc..
  • t
    tim
    Any green today is a victory...nice relative strength!
    Bullish
  • J
    J
    RBC - EXEL: Cabo Q4 pre-report & 2022 guide adds commercial confidence ahead of pipeline advancements in '22 (Outperform PT 31)
  • T
    Tam
    3 Biotech Stocks Wall Street Thinks Could Soar 50% or More in 2022 (Motley Fool)

    Speights: Analysts also think Exelixis (NASDAQ:EXEL) could jump 50 percent or more. What do you think?

    Orelli: Yeah, Exelixis is a really weird company because it has Cabometyx that's approved for a couple of different types of cancer, and it's trying to increase its sales. That will obviously increase its valuation. Then it's got a whole bunch of early stage pipeline candidates, they are all in Phase I or pre-clinical.

    You know early stage pipelines are really hard to value. Maybe some solid Phase I data from one or more of them could move the needle because there's probably not much valuation factored in right now. If they do get data then that could increase the valuation. But I think most of the value right now is Cabometyx.

    The big growth came from the approval of Cabometyx with the Bristol Myers Squibb's Opdivo in combination. That happened in January of 2021. All the easy year-over-year comparisons are now done if for 2022.

    That leaves further expansion of Carbometrics through new clinical trial data. We'll get some data for a clinical trial for Carbo plus Opdivo plus Bristol-Myers Squibb's Yervoy in renal cell cancer that's expected this year. There's a lot of potential to increase 50 percent, but it's based on clinical trial data, which is probably going to be hard to predict.
  • R
    Roop
    Fact: 1/23/2017 Stock closed $18.57, Fast forward today 1/12/22 closing price: $18.27

    While most of the top management has received over $100M in stock based compensation every year or over $500M in total stock option compensation while has done nothing...........something is really wrong the way stock based compensation is being dolled out at Exelixis while stock holder are getting nothing to hold their shares. In order to align the interest of the management with stock holders, stock based compensation must be tied to the stock price. Love to hear your feedback.
  • N
    Neil
    Amazing that we were green all day despite everything being down including all the biotech index's. If volume were up significantly above the average I would think that something is cooking, but it wasn't so perhaps its just being its contrary self today.

    GLTALs

    Neil
  • D
    Duck
    So...50% YoY growth in the quarter for US Cabo sales (net product revs) and 46% full year growth for US Cabo sales (net product revenues) and most of the posters here think it's a head fake. The sad part is of course the shareholders aren't getting any love for all this growth, but is this a real valuation today....or is this one of the most undervalued revenue stage biotechs in the market? Strong buy perhaps?
    Bullish
  • W
    William
    Breaking EXEL news... {from Reuters at 1600 Eastern time} --> Exelixis just announced preliminary results & provided 2022 guidance. Thoughts from the old-timers here?
    Neutral
  • M
    Mitchell
    Just doubled down on my position with the dip today.
    People understand that biotech is down in the last 12 months right?
    Fidelity biotech FBIOX is down 22% in the last 12 months.
    HQL's distribution is now over 9%.

    I think the market is under valuing EXEL's research pipeline. 11 different compounds and products. There are companies with market caps over a billion with less potential in the pipeline and management has not proven to bring a product to market like this one.

    What they are doing with Vicki Goodman and building the company nationally and internationally is exciting.

    The stock is not for everybody. It's not a CD that yields 1%.
    Bullish
  • M
    Mitchell
    I would love to hear company commentary(MMM or Lamb) about the results for Colorectal cancer. There are no media events scheduled on their web site.

    All of these patient's cancers were metastasized so we are talking bout very sick people. It would be wonderful to give them hope with an alternative treatment.
    Bullish
  • M
    Mitchell
    Let's remember that when I bought this stock 2 1/2 years ago Cobimetinib was supposed to be our next big product. The partnership with Genentech. It was in late stage trials and the hope is that by now we would be getting a few hundred million in revenues from this.

    It did not work out and did not deliver the clinical results needed. So that was a blow. Nobody's fault. It is a reality of the business but that was one of the things that weighed on our stock price.

    Now I would like to know the status of MINNEBRO(Esaxerenone) the blood pressure med sold in Japan through Sankyo. We had stellar results indicating it reduces kidney failure in diabetic patients. It has potential other uses as well. I would like to know if there is any plan to roll that out in North America or Europe. Have not heard much about that lately.
    Bullish
  • J
    J
    Dr. Vicki Goodman
    Company: Bristol-Myers Squibb
    Title: VP and Development Lead, Opdivo/Yervoy Melanoma/GU

    Take a look at Dr. Vicki Goodman’s R&D resume and you’ll see several of the boldest-face brand names in oncology these days. The melanoma duo Tafinlar and Mekinist, for example, which she worked on during a stint at GlaxoSmithKline.

    But the boldest name of all is Opdivo, Bristol-Myers Squibb’s breakthrough immuno-oncology treatment, now approved in a variety of cancers--and in development for more.

    Opdivo is one of the most closely watched products on the pharma scene, but Goodman isn’t one to be intimidated by its place in the spotlight. She’s been expecting big advances in cancer treatment for years. Working in a lab during her medical training, she quickly realized that new insights into the molecular basis of cancer “would fundamentally change how cancer is treated,” she said. And she wanted to be a part of that.

    Plus, Goodman is too busy to be dazzled. In her charge is not only Opdivo, but Opdivo in combination with Yervoy, a complementary cancer immunotherapy first approved in 2011. With a new development team she launched just over a year ago, she’s ushered Opdivo and Yervoy through U.S. and E.U. approval as the first immuno-oncology combination therapy in melanoma, and saw Opdivo to an FDA nod in kidney cancer, too.

    “It’s been a great experience to be a part of the development of these drugs,” Goodman said.
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