I've been in and out of $EXEL. Don't know enough about their science to recommend but they are on my due diligence list For now I am trading the stock conservatively, buying at support and selling covered calls once the price justifies it. Took an entry level today after it showed broke over $24
www.exelixis.com/ Founded in 1994, Exelixis, Inc. (Nasdaq: EXEL) is a commercially successful, oncology-focused biotechnology company that strives to accelerate the discovery, development and commercialization of new medicines for difficult-to-treat cancers. Following early work in model genetic systems, we established a broad drug discovery and development platform that has served as the foundation for our continued efforts to bring new cancer therapies to patients in need. We discovered our lead compounds, cabozantinib and cobimetinib, and advanced them into clinical development before entering into partnerships with leading biopharmaceutical companies in our efforts to bring them to patients globally. With growing revenues from the three resulting commercialized products – CABOMETYX®, COMETRIQ®, and COTELLIC® – we are reinvesting in our business to maximize the potential of our pipeline, which we intend to supplement with targeted business development activities and internal drug discovery, all to deliver the next generation of Exelixis medicines and help patients recover stronger and live longer.
1H 2017 $180m
Cash 6/30/17 $350m ST $26m LT Debt none
Cometriq (cobazontinib) FDA approved Nov 2012 thyroid carcinoma "MTC"
Cotellic (cobimetinib) FDA approved Nov 2015 metastatic melanoma
Cabometyx 4/26/16 FDA approved treatment for renal cell carcinoma "RCC"
Exelixis, Inc. (EXEL) (NASDAQ:EXEL) today announced that it has earned a $10 million milestone payment from Bristol-Myers Squibb under the terms of the two companies’ worldwide collaboration for compounds targeting retinoic acid-related orphan receptor (ROR), a family of nuclear hormone receptors implicated in inflammatory conditions. The milestone payment was triggered by Bristol-Myers Squibb’s filing of a Clinical Trial Authorization in Europe for a first-in-human study of a RORγt inverse agonist.
“Exelixis is closely focused on oncology today, but our legacy of drug discovery across diverse therapeutic areas lives on through our collaborations with our partners, including the RORγt inverse agonist program now advanced by Bristol-Myers Squibb,” said Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis. “We congratulate Bristol-Myers Squibb on its plans for a first-in-human study and look forward to future updates.”
From October 2010 to July 2013, Exelixis and Bristol-Myers Squibb undertook collaborative research around RORγt, with Exelixis and Bristol-Myers Squibb responsible for the discovery, optimization, and characterization of RORγt inverse agonists that could subsequently be developed and commercialized by Bristol-Myers Squibb. Since the end of the collaborative research period, Bristol-Myers Squibb has been solely responsible for all further research, development, manufacture, and potential commercialization of compounds developed under the collaboration, as well as all related costs and expenses. Exelixis received an upfront payment at the start of the collaboration in 2010, as well as a $2.5 million development milestone related to preclinical progress in February 2017. Exelixis could potentially receive additional development and regulatory milestones of up to $240 million, commercialization milestones of up to $150 million, and royalties on net sales depending on the advancement of the product candidate and eventual product.
While cabozantinib is approved in two indications, digging a moat will be tough for Exelixis. by Kelsey Tsai Equity Analyst Authors can be reached at Analyst Feedback Morningstar's Editorial Policies Analyst Note After 2Q Results, Increasing Exelixis' FVE to $20 on More Optimistic Cabometyx Outlook by Kelsey Tsai, 08/09/2017 Discuss Analyst Note 08/09/2017 We are increasing our fair value estimate for Exelixis to $20 per share from $17.20 to account for our more optimistic outlook for Cabometyx (cabozantinib) in advanced kidney cancer in the relapsed and front-line settings. In the second quarter, Exelixis reported a nice ramp in Cabometyx sales driven by strong growth in new patient starts. Our full-year operating expense forecast is in line with management’s reiterated guidance of $290 million-$310 million. While we believe it is too early to award the company an economic moat, we may consider upgrading our moat trend rating to positive from stable if Cabometyx is established as a major player in the treatment-naive kidney cancer patient population.
Revenue from Exelixis’ lead drug, Cabometyx, increased 30% quarter over quarter, driven primarily by robust patient volume growth (up 25% quarter over quarter), especially among community prescribers. We believe this year marks a turning point for the company, which has historically operated in the red, to sustainable profitability. Cometriq, which is the same molecule as Cabometyx under different branding for the medullary thyroid cancer population, showed declining revenue from the year prior, as patients who previously used the drug off-label switched to Cabometyx. We expect little to no growth in this indication; our valuation rests on increased Cabometyx market share in kidney cancer and eventual approval in liver cancer.
Investment Thesis 08/09/2017 Exelixis is best known for its prowess in discovering targeted cancer drugs, which left a legacy of oncology drug partnerships with multiple Big Pharma players. Its priorities have evolved to focus on its lead drug cabozantinib, which gained approval in the small medullary thyroid cancer market in 2012 and the larger renal cell carcinoma market in 2016. We are optimistic for the future of the cabozantinib franchise but believe the firm’s long-term outlook remains highly uncertain, given the competitive oncology market and Exelixis’ prioritization of its lead drug at the expense of its early-stage pipeline.
Cabozantinib--marketed as Cometriq in MTC and Cabometyx in RCC--has shown remarkable efficacy and the potential to play a key role in oncologic combo regimens. However, the launch of Cometriq introduced a limited stream of sales, and Cabometyx, while off to a good start, faces a highly competitive market. Exelixis does not have the capital to invest in multiple pivotal trials at once, which limits the pace of label expansion. The company is currently focused on expansion into liver cancer and first-line RCC. A plethora of investigator-sponsored trials are evaluating cabozantinib in other indications, which require minimal up-front cost from Exelixis, but the direction and timing are largely out of the firm’s control.
After Bristol returned its rights to cabozantinib to Exelixis in 2010, Exelixis shifted its resources to bring the drug to market. While necessary, we believe this strategy limited the company’s early-stage pipeline. The firm’s partnered drug with Roche, Cotellic (in combo with Zelboraf) for the treatment of melanoma, launched in 2015 with favorable revenue-sharing terms but has struggled to gain traction in the crowded indication. Larger opportunities lie in the colorectal cancer and melanoma markets, in combination with Roche’s immuno-oncology drug Tecentriq. Exelixis has other midstage partnerships with Daiichi Sankyo and Sanofi, in addition to several very early-stage candidates with Merck and Bristol. Partnerships limit the cost of development for Exelixis, but the firm generally cedes a large portion of the profit and control.
Economic Moat 08/09/2017 While Exelixis has generated some notable wins with the launch of Cabometyx and partner drug Cotellic, we are hesitant to award a moat, given the company’s high level of product concentration and steep competition in the oncology market.
The company has yet to achieve sustainable profitability. Cometriq in medullary thyroid carcinoma targets a limited patient population and historically could not offset the heavy research and development costs incurred by the firm. Continued uptake in Cabometyx sales, as well as anticipated Cotellic royalties from Exelixis’ partner Roche, should help lead the company toward a path out of the red, based on our estimates. However, we would like to see significant label expansion or more evidence of strong efficacy and safety in combination regimens before upgrading Exelixis’ rating from no moat. Cabozantinib and cobimetinib hold strong patent protection until at least 2024 and 2026, respectively, but increased competition from immuno-oncology drugs and the growing pipeline of combination therapies adds uncertainty to the commercial success of these potential franchises.
The recent expansion of cabozantinib into the larger second- and third-line kidney cancer populations is encouraging, but its side effect profile leaves room for competition. Cabometyx’s pivotal Meteor trial demonstrated the drug’s strong efficacy across three major endpoints--overall survival, progression free survival, and objective response rate--which provides an edge over other second-line therapies on the market. However, 60% of patients on the treatment in clinical trials had to lower their dosage due to intolerable side effects. While we believe cabozantinib’s strong efficacy profile has allowed Exelixis to gain market share at the expense of other monotherapy tyrosine kinase inhibitors, we are wary that the flurry of combination drug trials may provide better efficacy with similar safety profiles. Cabozantinib could also prove to be a successful agent in a combination regimen, but as a small biotech firm, Exelixis has limited capital to deploy across multiple clinical trials. The company is currently focusing its resources to expand the cabozantinib label into other cancer indications, specifically liver cancer.
Expansion across different indications could provide a larger patient base and more diverse revenue streams. However, we would need to see a more robust late-stage pipeline to merit a moat. The company’s failed 2014 bid into prostate cancer highlights the need to have multiple shots on net. However, Exelixis is still in a cash-burning stage and has limited capital to internally run a suite of trials. We anticipate Exelixis will be able to position cabozantinib in the first-line progressive renal cell carcinoma market, given the positive top-line results from the pivotal, investigator-sponsored Cabosun trial, and the firm remains on track to expand to second-line liver cancer (data expected in the second half of 2017). The firm could also benefit from successful results from other investigator- or partner-sponsored trials. This strategy could prove lucrative--Cabosun, for example, was an investigator-sponsored trial and required minimal up-front development cost--but the lack of direct control over the pace and design of the trials prevents us from assigning a moat advantage on this basis. Save for Roche’s trials to expand Cotellic into colorectal cancer and BRAF-mutated melanoma, as well as Daiichi Sankyo’s hypertension candidate for the Japanese market, the rest of Exelixis’ partnered pipeline is early stage.
Valuation 08/09/2017 We are increasing our fair value estimate to $20 per share from $17.20 to account for our more optimistic outlook for Cabometyx (cabozantinib) in advanced kidney cancer in the relapsed and front-line settings. Our fair value estimate rests on the success of Exelixis’ cabozantinib franchise. For its ongoing phase 3 trial in advanced hepatocellular carcinoma, we assign a probability of 60%. Overall, this results in global probability-adjusted peak sales over $1 billion and assumes the drug becomes a key contender in the renal cell carcinoma market. For Cotellic, which was approved for advanced BRAF-positive melanoma patients, we expect peak sales of less than $200 million in melanoma in the U.S. and Europe and total sales of more than $200 million including probability-adjusted sales in potential colorectal cancer and triple-negative breast cancer indications. Exelixis receives a 30%-50% royalty in the U.S. and low-double-digit royalties elsewhere due to its partnership agreement with Roche. For the remaining candidates, we assign a 10%-60% probability of approval based on their early-stage development status, save for Daiichi Sankyo’s phase 3 candidate for the treatment of hypertension in Japanese patients, where we assign a 60% probability of approval. We assume low-double-digit royalties on sales for partnered products. Our probability-weighted sales projections, coupled with our expectations of robust license and milestone payments, yield over 40% compound annual revenue growth during the next five years. While Exelixis can rely on partners to shoulder development costs and its restructuring efforts have limited its burn rate, we expect R&D expenses will remain significant as cabozantinib is evaluated in other indications.
Risk 08/09/2017 Although Exelixis has several partnered compounds in clinical development, it remains highly dependent on the success of its cabozantinib franchise. Cometriq has limited revenue potential in the small MTC market. While the opportunity is larger in the kidney and liver cancer markets, the company faces significant threats from new immuno-oncology drugs and combination regimens in development by competitors. Expansion beyond these markets into other oncologic indications will probably face similar competition, which could limit the potential of Exelixis’ lead drug. Since nearly all of Exelixis’ product revenue comes from the United States, the firm is exposed to pricing pressure on its high-cost oncology drugs. In particular, the shift toward double and triple combo drug treatments in cancer may result in lower individual drug costs to make the regimen palatable to payers.
Furthermore, there is no guarantee that other partnered pipeline drugs will be viable, as the development of several formerly attractive early-stage candidates has been discontinued in the past. Exelixis’ development of cabozantinib in liver cancer and other indications could also fail to gain approval. The company has not yet reached a sustainable level of profitability, which heightens the risk from such a high product and development focus on cabozantinib. Failure to translate cabozantinib development into ongoing monetary success may force Exelixis to restructure and reduce head count to weather the loss, as it has resorted to in the past, or risk going out of business.
Management 05/02/2017 We award Exelixis a Standard stewardship rating. In 2010, Michael Morrissey, formerly the president of R&D at Exelixis, replaced longtime CEO George Scangos, who left the company to lead Biogen. The CEO transition coincided with the return of cabozantinib rights to Exelixis from its partner, Bristol, due to competing priorities. Without the support of a developmental partner, Morrissey restructured the company away from its discovery platform model to focus primarily on progressing cabozantinib. We think this decision was reasonable, given the unsustainably high cost of R&D that this approach entailed and the challenging financing environment that the company faced at that time.
We approve of the board's decision to pay Morrissey less lavishly than his predecessor (Scangos made well above $4 million in his last full year as CEO), especially given the company's steep accumulated deficit and still-distant prospects for profitability. We also like the company’s experienced board of directors, whose ranks include several prominent healthcare academics. We are comforted by the fact that Scangos remains on the board and cofounder Stelios Papadopoulos is chairman.
Exelixis’ Phase 3 CELESTIAL Trial of Cabozantinib Meets Primary Endpoint of Overall Survival in Patients with Advanced Hepatocellular Carcinoma
Mon October 16, 2017 6:58 AM|Business Wire|About: EXEL – Exelixis (EXEL) to submit a supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) in the first quarter of 2018; cabozantinib previously granted orphan drug designation by FDA –
– Data to be submitted for presentation at an upcoming medical meeting –
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Exelixis, Inc. (NASDAQ:EXEL) today announced that its global phase 3 CELESTIAL trial met its primary endpoint of overall survival (OS), with cabozantinib providing a statistically significant and clinically meaningful improvement in median OS compared to placebo in patients with advanced hepatocellular carcinoma (HCC). The independent data monitoring committee for the study recommended that the trial should be stopped for efficacy following review of the second planned interim analysis. CELESTIAL is a randomized, global phase 3 trial of cabozantinib versus placebo in patients with advanced HCC who have been previously treated with sorafenib. The safety data in the study were consistent with the established profile of cabozantinib. Based on these results, Exelixis plans to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) in the first quarter of 2018. Detailed results from CELESTIAL will be submitted for presentation at a future medical conference.
“We are excited that these positive results from the phase 3 CELESTIAL trial bring us one step closer to the potential of offering previously treated patients with this aggressive form of advanced liver cancer a much-needed new treatment option,” said Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis. “This is an important milestone for the cabozantinib development program; we are committed to studying cabozantinib in a range of tumor types as part of our mission to deliver medicines that improve treatment outcomes and give patients hope for the future.”
Exelixis will discuss the trial results with regulatory authorities and determine next steps for the trial, including offering patients currently receiving placebo the opportunity to cross over to cabozantinib.
In March 2017, the FDA granted orphan drug designation to cabozantinib for the treatment of advanced HCC. Orphan drug designation is granted to treatments for diseases that affect fewer than 200,000 people in the U.S. and provides certain incentives for medications intended for the treatment, diagnosis or prevention of rare diseases. At present, these incentives include seven years of marketing exclusivity for the orphan indication, certain federal grants, tax credits, and waiver of certain FDA fees.
About the CELESTIAL Study CELESTIAL is a randomized, double-blind, placebo-controlled study of cabozantinib in patients with advanced HCC conducted at more than 100 sites globally in 19 countries. The trial was designed to enroll 760 patients with advanced HCC who received prior sorafenib and may have received up to two prior systemic cancer therapies for HCC and had adequate liver function. Enrollment of the trial was completed in September 2017. Patients were randomized 2:1 to receive 60 mg of cabozantinib once daily or placebo and were stratified based on etiology of the disease (hepatitis C, hepatitis B or other), geographic region (Asia versus other regions) and presence of extrahepatic spread and/or macrovascular invasion (yes or no). No cross-over was allowed between the study arms.
The primary endpoint for the trial is OS, and secondary endpoints include objective response rate and progression-free survival. Exploratory endpoints include patient-reported outcomes, biomarkers and safety.
Based on available clinical trial data from various published trials conducted in the second-line setting of advanced HCC, the CELESTIAL trial statistics for the primary endpoint of OS assumed a median OS of 8.2 months for the placebo arm. A total of 621 events provide the study with 90 percent power to detect a 32 percent increase in median OS (HR = 0.76) at the final analysis. Two interim analyses were planned and conducted at 50 percent and 75 percent of the planned 621 events.
Exelixis Announces U.S. FDA Grants Priority Review for CABOMETYX® (Cabozantinib) as a Treatment for Previously Untreated Advanced Renal Cell Carcinoma
Mon October 16, 2017 6:59 AM|Business Wire|About: EXEL – FDA assigns Prescription Drug User Fee Act action date of February 15, 2018 –
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Exelixis, Inc. (EXEL) (NASDAQ:EXEL) today announced that the U.S. Food and Drug Administration (FDA) has determined the company’s supplemental New Drug Application (sNDA) for CABOMETYX® (cabozantinib) for patients with previously untreated advanced renal cell carcinoma (RCC) to be sufficiently complete to permit a substantive review. The FDA granted Priority Review of the filing and assigned a Prescription Drug User Fee Act (PDUFA) action date of February 15, 2018.
“The acceptance of the sNDA filing with a Priority Review is an important regulatory milestone for CABOMETYX and for our mission to improve treatment outcomes for patients with cancer,” said Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis. “We look forward to working with the FDA as they review the application in our effort to offer CABOMETYX to patients with previously untreated metastatic RCC who are in need of new treatment options.”
The sNDA is based on data from CABOSUN, a randomized phase 2 trial conducted by The Alliance for Clinical Trials in Oncology as part of Exelixis’ collaboration with the National Cancer Institute’s Cancer Therapy Evaluation Program (NCI-CTEP).
An sNDA is an application to the FDA that, if approved, will allow a drug sponsor to make changes to a previously approved product label, including modifications to the indication. CABOMETYX was previously approved by the FDA on April 25, 2016 for the treatment of patients with advanced RCC who have received prior anti-angiogenic therapy. The approval was based on results from the phase 3 METEOR trial, which demonstrated that CABOMETYX provided a statistically significant and clinically meaningful improvement in overall survival, progression-free survival (PFS), and objective response rate as compared with everolimus in this patient population.
On May 23, 2016, Exelixis announced that CABOSUN met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in PFS compared with sunitinib in patients with advanced intermediate- or poor-risk RCC as determined by investigator assessment. CABOSUN was conducted by The Alliance for Clinical Trials in Oncology as part of Exelixis’ collaboration with the NCI-CTEP. These results were first presented by Dr. Toni Choueiri at the European Society for Medical Oncology (ESMO) 2016 Congress (CACOX), and published in the Journal of Clinical Oncology (Choueiri, JCO, 2016).1 In June 2017, a blinded independent radiology review committee (IRC) confirmed that cabozantinib provided a clinically meaningful and statistically significant improvement in the primary efficacy endpoint of investigator-assessed PFS. Results from the IRC review were presented by Dr. Toni Choueiri at the ESMO 2017 Congress.
CABOSUN was a randomized, open-label, active-controlled phase 2 trial that enrolled 157 patients with advanced RCC determined to be intermediate- or poor-risk by the IMDC criteria. Patients were randomized 1:1 to receive cabozantinib (60 mg once daily) or sunitinib (50 mg once daily, 4 weeks on followed by 2 weeks off). The primary endpoint was PFS. Secondary endpoints included overall survival and objective response rate. Eligible patients were required to have locally advanced or metastatic clear-cell RCC, ECOG performance status 0-2 and had to be intermediate or poor risk per the IMDC criteria (Heng, JCO, 2009).2 Prior systemic treatment for RCC was not permitted.
Morningstar bull/bear Bulls Say • Cabozantinib has shown activity in a variety of cancers, and label expansion could significantly expand the drug’s market opportunity. • Its partnerships allow Exelixis to reap benefits from drug candidate progression with limited development cost obligations. • Exelixis' partnerships with larger players such as Roche/Genentech, Bristol, and Merck help fund drug development and lend credibility to the firm's potential.
Bears Say • Exelixis has yet to hit sustainable levels of profitability, and its future hinges on the success of its cabozantinib franchise, which competes in crowded oncologic indications. • The failure of cabozantinib in the prostate cancer indication highlights the risks associated with Exelixis' key oncology program. • Exelixis has prioritized cabozantinib's label expansion at the expense of its early-stage pipeline, which could curb the company’s long-term potential.
Under: Been on the sidelines for a bit holding (building) cash. Now that "BIGLEY" has rolled out the tax plan its time to jump in.
Dec 21, 2017 19:06:02 GMT -6
martyc: Looks like you are buying Msft again!
Dec 15, 2017 11:23:29 GMT -6
martyc: The news that Trump called Rupert to congratulate him sure seems to indicate that this is heading to approval
Dec 15, 2017 11:22:23 GMT -6
Under: DIS finally getting some traction.?
Dec 14, 2017 17:08:45 GMT -6
martyc: I took an entry level position in DIS. Will add eventually to overweight when it becomes clearer that the deal will go thru. Can't believe how well positioned they will be. 60% Hulu. 20% of content watched on NFLX they can pull. More in thread
Dec 14, 2017 11:05:16 GMT -6
Under: Great posts on $DIS
Dec 13, 2017 17:50:49 GMT -6
Under: $ROKU Citron on a war path.
Nov 28, 2017 15:11:20 GMT -6
Under: $HAS takeover bid for $MAT?
Nov 10, 2017 16:16:07 GMT -6
martyc: Not looking like the market will provide any discounted opp for SGMO. Call was just too professional and all signs indicate they are on a great path for commercialization. Happy with core but wish I had some trading shs
Nov 10, 2017 9:04:05 GMT -6
martyc: For anyone looking to find an entry point into SGMO, I'm almost hoping is sells off in next few days so I can add more. They are really clicking but the fact they haven't signed new deals might cause some to exit. Watching as I have room for trading shs
Nov 9, 2017 18:28:09 GMT -6
martyc: Been an interesting ride so far. I figured the Bears would be about this good but hoped the O wouldn't look so lame. Another building yr but still possible to get to 8-8 IMO
Nov 9, 2017 18:26:08 GMT -6
Under: whats up with your Bears this year Marty?
Nov 9, 2017 17:35:25 GMT -6
martyc: Hope you were long ROKU. I wanted to see Q first so missed out
Nov 9, 2017 7:08:53 GMT -6