EXELIXIS
Exelixis’ (EXEL) shareholders know well how good are the firm’s announced financial results for the second quarter of 2017. They also know well how good is the update presented by the firm about the progress made towards fulfilling its commercial and clinical development milestones.
Exelixis report left no reason for complaining, criticizing or downgrading the firm’s stock. As a matter of fact, the presentation looked as if an ideal strategy from a textbook addressed to small biotech firms so they can adopt following their transition from development-stage firms to revenues’ generating firms. Shockingly, some market gurus and traders were still capable of creating ways to put pressure on EXEL following the firm’s successful presentation of its financial results and guidance.
A stock downgrade, and unintelligible selloff occurred before, during, and after the presentation. Adding harm to the injuries caused by the downgrade was traders selling the stocks as they always do following what has become a pattern during the season of the quarterly financial results. During this season, professional players and daily traders sell the biotech stock even without reading the firms’ press releases, or hearing what the firms announce during the conference calls.
Earlier in the week, a selloff has nailed Incyte’s (INCY) stock because the firm missed analysts’ expectations of Incyte’s EPS by one sent. For the critics and unfair assessors, all the positive news reported from clinical trials about firms’ products are never worth considering. For us, though, the science, technology, products’ promises and their mid- and final clinical trial results are what we consider most in the evaluation of the biotech stocks.
* * * *
It is obvious that Exelixis has never lost its focus on getting the best out of its approved and marketed drugs cabozantinib and cobimetinib. Getting the best out of these drugs means testing the drugs on various cancers alone and in combination with other targeted products and with approved or investigational immunotherapy products.
The good news is that while testing its products on a variety of cancers, in addition to testing them for earlier use in their approved indications, Exelixis never lost focus on its priority duty during the past approval period, i.e., putting a lot of effort on commercializing the newly approved drugs.
Highlights of Q2 Financial Results and Other Accomplishments
During the second quarter of 2017, Exelixis’ drug Cabometyx® generated $80.9 million in net product revenue, while Cometriq® (cabozantinib) capsules for progressive, metastatic medullary thyroid cancer generated an additional $7.1 million in net product revenue. The combined net revenues for the cabozantinib franchise was $88.0 million.
Cabozantinib $88 million net revenues during the second quarter of 2017, represent an increase of 28% over the first quarter of 2017. It represents an increase of 178 % year-over-year. The year-over-year increase was driven primarily by the FDA approval in April 2016 of the drug as a treatment for patients with advanced RCC who have received prior anti-angiogenic therapy.
Great Meaningful Accomplishments
– Several new trials are recently initiated for cabozantinib combination therapy with leading immunotherapies for genitourinary cancer indications.
Exelixis and Bristol-Myers Squibb (BMS) announced the initiation of the phase 3 trial evaluating cabozantinib in combination with two of BMS’ immunotherapies, nivolumab and ipilimumab, compared to sunitinib. The trial is planned to enroll 1,014 treatment-naïve patients, and the primary endpoint is PFS.
– Launch of Phase 1b Trial of cabozantinib with atezolizumab in Patients with locally advanced or metastatic urothelial carcinoma (UC).
– The management has retired the final portion of its remaining corporate debt.
– Exelixis’ announced a favorable settlement of its dispute with Genentech concerning cobimetinib, which Exelixis initiated in June 2016.
Exelixis announced a settlement of its arbitration with Genentech concerning claims related to the development and commercialization of cobimetinib, the Exelixis-discovered drug marketed as COTELLIC®. The revised revenue and cost-sharing arrangement resolves the companies’ dispute pursuant to the arbitration demand filed on June 3, 2016, and aligns both companies’ interests in advancing cobimetinib as a promising therapy for patients with multiple forms of cancer.
– Continued progress on filing related to previously untreated advanced RCC. Exelixis remains on track to file its sNDA for cabozantinib in the third quarter of 2017.
CATALISTS
– CELESTIAL data anticipated in the second half of 2017.
CELESTIAL, the ongoing phase 3 pivotal trial of cabozantinib in patients with ADVANCED HEPATOCELLULAR CARCINOMA (HCC), continues to progress. Exelixis anticipates that the second interim analysis at 75 percent of the required events will be completed in the second half of 2017.
– Cabozantinib and cobimetinib data presentations at the ESMO 2017 Congress.
Exelixis compounds will be the subject of 10 presentations at the ESMO 2017 Congress, which is being held September 8-12, 2017 in Madrid, Spain. Data from CABOSUN, the randomized phase 2 trial of cabozantinib versus sunitinib in patients with previously untreated advanced RCC, have been accepted as a late-breaking abstract at the meeting and will be the subject of a poster discussion on Sunday, September 10th.
– Cobimetinib Now the Subject of Three Phase 3 Pivotal Trials. Roche recently confirmed it anticipates enrolling the first patient in IMspire170, the phase 3 pivotal trial of cobimetinib and atezolizumab versus pembrolizumab in first-line BRAF wild-type metastatic or unresectable locally advanced melanoma, in the third quarter of 2017.
Alongside the fully enrolled IMblaze370 trial (third-line advanced metastatic colorectal cancer) and the currently recruiting IMspire150 TRILOGY (first-line BRAF V600 mutation-positive metastatic or unresectable locally advanced melanoma), cobimetinib is now the subject of three phase 3 pivotal trials where it is being evaluated in combination with other anticancer therapies.
Prohost Observations
Commenting on downgrade Exelixis’ stock after the firm revealed its financial numbers, strategy and accomplishments, a blogger wrote: “Would it be the significant beat on earnings? Maybe the blowout numbers on revenues? Or maybe the likely significant increase in future revenues when the all but certain label expansion comes? Or maybe they are just trying to help their clients get a better entry point.”
It doesn’t matter, the man wrote, adding, “This is how Wall Street works. You just have to see it as an opportunity.”
We certainly did.
That’s enough for today. The next article will tackle another small cancer drug developing firm and very important news.
Prohost Forward-Looking: Material presented here is for informational purposes only. Nothing in this article should be taken as a solicitation to purchase or sell securities. Before buying or selling any stock you should do your own research and reach your own conclusion. Further, these are our ‘opinions’ and we may be wrong. We may have positions in securities mentioned in this article. You should take this into consideration before acting on any advice given in this article. If this makes you uncomfortable, then do not listen to our thoughts and opinions. The contents of this article do not take into consideration your individual investment objectives so consult with your own financial adviser before making an investment decision. Investing includes certain risks including loss of principal.
News & Comments
August 8, 2017
About Exelixis’ Transition
EXELIXIS
Exelixis’ (EXEL) shareholders know well how good are the firm’s announced financial results for the second quarter of 2017. They also know well how good is the update presented by the firm about the progress made towards fulfilling its commercial and clinical development milestones.
Exelixis report left no reason for complaining, criticizing or downgrading the firm’s stock. As a matter of fact, the presentation looked as if an ideal strategy from a textbook addressed to small biotech firms so they can adopt following their transition from development-stage firms to revenues’ generating firms. Shockingly, some market gurus and traders were still capable of creating ways to put pressure on EXEL following the firm’s successful presentation of its financial results and guidance.
A stock downgrade, and unintelligible selloff occurred before, during, and after the presentation. Adding harm to the injuries caused by the downgrade was traders selling the stocks as they always do following what has become a pattern during the season of the quarterly financial results. During this season, professional players and daily traders sell the biotech stock even without reading the firms’ press releases, or hearing what the firms announce during the conference calls.
Earlier in the week, a selloff has nailed Incyte’s (INCY) stock because the firm missed analysts’ expectations of Incyte’s EPS by one sent. For the critics and unfair assessors, all the positive news reported from clinical trials about firms’ products are never worth considering. For us, though, the science, technology, products’ promises and their mid- and final clinical trial results are what we consider most in the evaluation of the biotech stocks.
* * * *
It is obvious that Exelixis has never lost its focus on getting the best out of its approved and marketed drugs cabozantinib and cobimetinib. Getting the best out of these drugs means testing the drugs on various cancers alone and in combination with other targeted products and with approved or investigational immunotherapy products.
The good news is that while testing its products on a variety of cancers, in addition to testing them for earlier use in their approved indications, Exelixis never lost focus on its priority duty during the past approval period, i.e., putting a lot of effort on commercializing the newly approved drugs.
Highlights of Q2 Financial Results and Other Accomplishments
During the second quarter of 2017, Exelixis’ drug Cabometyx® generated $80.9 million in net product revenue, while Cometriq® (cabozantinib) capsules for progressive, metastatic medullary thyroid cancer generated an additional $7.1 million in net product revenue. The combined net revenues for the cabozantinib franchise was $88.0 million.
Cabozantinib $88 million net revenues during the second quarter of 2017, represent an increase of 28% over the first quarter of 2017. It represents an increase of 178 % year-over-year. The year-over-year increase was driven primarily by the FDA approval in April 2016 of the drug as a treatment for patients with advanced RCC who have received prior anti-angiogenic therapy.
Great Meaningful Accomplishments
– Several new trials are recently initiated for cabozantinib combination therapy with leading immunotherapies for genitourinary cancer indications.
Exelixis and Bristol-Myers Squibb (BMS) announced the initiation of the phase 3 trial evaluating cabozantinib in combination with two of BMS’ immunotherapies, nivolumab and ipilimumab, compared to sunitinib. The trial is planned to enroll 1,014 treatment-naïve patients, and the primary endpoint is PFS.
– Launch of Phase 1b Trial of cabozantinib with atezolizumab in Patients with locally advanced or metastatic urothelial carcinoma (UC).
– The management has retired the final portion of its remaining corporate debt.
– Exelixis’ announced a favorable settlement of its dispute with Genentech concerning cobimetinib, which Exelixis initiated in June 2016.
Exelixis announced a settlement of its arbitration with Genentech concerning claims related to the development and commercialization of cobimetinib, the Exelixis-discovered drug marketed as COTELLIC®. The revised revenue and cost-sharing arrangement resolves the companies’ dispute pursuant to the arbitration demand filed on June 3, 2016, and aligns both companies’ interests in advancing cobimetinib as a promising therapy for patients with multiple forms of cancer.
– Continued progress on filing related to previously untreated advanced RCC. Exelixis remains on track to file its sNDA for cabozantinib in the third quarter of 2017.
CATALISTS
– CELESTIAL data anticipated in the second half of 2017.
CELESTIAL, the ongoing phase 3 pivotal trial of cabozantinib in patients with ADVANCED HEPATOCELLULAR CARCINOMA (HCC), continues to progress. Exelixis anticipates that the second interim analysis at 75 percent of the required events will be completed in the second half of 2017.
– Cabozantinib and cobimetinib data presentations at the ESMO 2017 Congress.
Exelixis compounds will be the subject of 10 presentations at the ESMO 2017 Congress, which is being held September 8-12, 2017 in Madrid, Spain. Data from CABOSUN, the randomized phase 2 trial of cabozantinib versus sunitinib in patients with previously untreated advanced RCC, have been accepted as a late-breaking abstract at the meeting and will be the subject of a poster discussion on Sunday, September 10th.
– Cobimetinib Now the Subject of Three Phase 3 Pivotal Trials. Roche recently confirmed it anticipates enrolling the first patient in IMspire170, the phase 3 pivotal trial of cobimetinib and atezolizumab versus pembrolizumab in first-line BRAF wild-type metastatic or unresectable locally advanced melanoma, in the third quarter of 2017.
Alongside the fully enrolled IMblaze370 trial (third-line advanced metastatic colorectal cancer) and the currently recruiting IMspire150 TRILOGY (first-line BRAF V600 mutation-positive metastatic or unresectable locally advanced melanoma), cobimetinib is now the subject of three phase 3 pivotal trials where it is being evaluated in combination with other anticancer therapies.
Prohost Observations
Commenting on downgrade Exelixis’ stock after the firm revealed its financial numbers, strategy and accomplishments, a blogger wrote: “Would it be the significant beat on earnings? Maybe the blowout numbers on revenues? Or maybe the likely significant increase in future revenues when the all but certain label expansion comes? Or maybe they are just trying to help their clients get a better entry point.”
It doesn’t matter, the man wrote, adding, “This is how Wall Street works. You just have to see it as an opportunity.”
We certainly did.
That’s enough for today. The next article will tackle another small cancer drug developing firm and very important news.
Prohost Forward-Looking: Material presented here is for informational purposes only. Nothing in this article should be taken as a solicitation to purchase or sell securities. Before buying or selling any stock you should do your own research and reach your own conclusion. Further, these are our ‘opinions’ and we may be wrong. We may have positions in securities mentioned in this article. You should take this into consideration before acting on any advice given in this article. If this makes you uncomfortable, then do not listen to our thoughts and opinions. The contents of this article do not take into consideration your individual investment objectives so consult with your own financial adviser before making an investment decision. Investing includes certain risks including loss of principal.
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