- Switzerland-based pharmaceutical company Roche Holding Limited (RHHBY) has had a topsy-turvy year so far.
- During the first half of 2014, Roche’s net incomes fell almost 7% as compared to the first six months of 2014.
- Over the course of the year, Roche has expanded its portfolio and has branched out towards newer markets in order to seek further avenues for growth.
- Roche faced failures in the clinical trial stages for not one but two of its drugs. The company was seeking treatments for Alzheimer’s as well as breast cancer.
- It will be in the investors’ best interests to currently steer clear from buying into Roche’s stock as future revenue generation and earnings growth is not visible at the moment.
- The Phase III MARIANNE study of Kadcyla delivered a major disappointment as this would-be successor to Herceptin failed to show superior efficacy alone or in combination with Perjeta.
- Roche also announced the end of another Alzheimer's program, casting further doubt on the company's ability to develop new drugs outside of its oncology franchise.
- Loss of Kadcyla upside suggests Roche is fairly valued today; a decent hold for investors looking for long-term exposure to oncology, but perhaps not as compelling for new investments.
Roche's Avastin Should Get The Nod From The FDA On November 19
- Avastin in combination with chemotherapy is approved in Europe for treating platinum-sensitive, platinum-resistant, as well as newly-diagnosed ovarian cancer, but is only used off-label in the U.S.
- FDA approval will be based on the AURELIA trial, where Avastin showed a significant improvement in the primary endpoint, progression-free survival (PFS), but no marked difference in overall survival.
- Avastin showed lower incidence of serious adverse effects than in previous trials; similarly, patients were significantly more satisfied, according to quality-of-life surveys, which supports the PFS benefits.
- Barring some serious safety information that hasn't become public, Avastin should be granted approval based on comments and recommendations formulated by the FDA workshop panel on cancer endpoints.
- If approved, Avastin can capture much of a $2 billion market of patients who relapse after first-line chemotherapy in ovarian cancer.
Roche's Cancer Drug Sales Continue To Grow, May Face Competition In The Medium TermLucrative Advice • Oct. 29, 2014
- Roche showed impressive performance as sales grew on the back of their growth in cancer drug sales. Revenue was spread across pharmaceuticals division as well as its diagnostics division.
- Growth in Roche’s pharmaceutical division was broad based as it wasn’t only the breast cancer treatment drugs that performed well.
- There are expectations of future competition in the market but Roche has strategized smartly in order to deal with the market saturation.
- Roche is aiming to grow its portfolio beyond oncology to immunology and ophthalmology.
- Investment in Roche is definitely rewarding and safe, and any future drop in prices should be considered an ideal entry point.
- Roche has seen Art Levinson, former CEO of Genentech, leave the board as his company Calico signs a major partnership with AbbVie.
- Roche has been making some odd M&A decisions of late (including a seeming lack of conviction about abandoning or doubling down in sequencing) and has seen top-notch talent go elsewhere.
- In a generally expensive sector, Roche screens as a decent investment option but the company needs to add more pharma experience to its board and strengthen its non-oncology business.
With An Iffy Non-Oncology Pipeline, Roche Pays Up For InterMune
- Roche comes out on top in what was rumored to be a multi-party bidding process for InterMune, agreeing to pay over $8 billion for the developer of Esbriet (for IPF).
- Even with incremental free cash flow margins above 50%, Roche has to generate more than $2 billion/year in U.S. sales to justify the price paid for InterMune.
- Roche's past failures in developing drugs outside of oncology likely pushed management toward this deal, but the shares still look modestly undervalued on mid-single digit growth expectations.
- The company is hopeful that by leveraging Genia's technology, it will be able to bring the cost of DNA sequencing down and at the same time improve its speed and sensitivity.
- If DNA sequencing helps Roche in developing 1-2 targeted drugs for cancer and other serious illnesses, the incremental sales could be significant.
- The broader attempt appears to be toward strengthening the diagnostics business and gain share as Johnson & Johnson falters in this market.
Roche Hikes Dividend By 6%, Remains A Safe Yield Play
Roche: Impact Of Rituxan Patent Expiration In EuropePharma Reports • Oct. 21, 2013
Will Lost Patents Force Roche Into Acquisition Mode?
Roche Holdings: New Drugs Drive Oncology Unit's GrowthTrefis • Mar. 15, 2013
Feb. 3, 2014, 11:59 AM
- PDL BioPharma (PDLI -1.9%) says it reached agreement with Genentech and Roche (RHHBF, RHHBY) which resolves all outstanding legal disputes between the parties, including Nevada litigation and arbitration proceedings related to the audit of royalties on sales.
- Genentech will pay a fixed royalty rate of 2.125% on worldwide sales of Avastin, Herceptin, Lucentis Xolair, Kadcyla and Perjeta, rather than the previous tiered royalty rate in the U.S and the fixed rate on all ex-U.S. based manufactured and sold licensed products.
Jan. 30, 2014, 2:17 AM
- Roche's (RHHBF) 2013 net profit rose 18% to 11.4B Swiss francs ($12.7B), missing expectations of 11.62B francs.
- Core EPS +10% to 14.27 francs, falling short of consensus of 14.78 francs.
- Sales +3% to 46.8B francs topping estimates of 46.7B francs.
- Earnings were boosted by sales of Roche's oncology, immunology and ophthalmology products, as well as of its diagnostic offerings.
- Roche plans to increase its dividend by 6% to 7.80 francs a share.
- Roche forecasts that 2014 revenue will rise by a low- to mid-single-digit percentage at constant currencies and that core EPS will grow at a faster rate, with earnings boosted by sales of its biggest cancer drugs and new products. Kadcyla (breast cancer) and Gazyva (leukemia) were authorized in the U.S. last year. (PR)
Jan. 21, 2014, 7:00 AM
- Roche's (RHHBY) Bitopertin treatment for schizophrenia fell short of its main targets in two Phase III studies
- In combination with antipsychotic therapy, Bitopertin didn't significantly improve the negative symptoms of schizophrenia after 24 weeks of treatment compared with a placebo.
- Roche is continuing to carry out another Phase III study of Bitopertin for schizophrenia, and late-stage trials to assess its effect on symptoms such as hallucinations and delusions.
- The results are a particular blow, as Roche has increased its investment in neuroscience in recent years as it looks to expand beyond it core expertise of oncology.
- Shares are +0.1% in Zurich. (PR)
Dec. 23, 2013, 6:05 PM
- Carlyle Group (CG) appears to be the leader to acquire Johnson & Johnson's (JNJ) clinical diagnostics unit, beating out P-E peer Blackstone (BX) and its partner Danaher (DHR), Reuters reports.
- The exact price of CG's offer is not known, but a deal likely would fetch ~$4B and could be completed within the next two weeks.
- JNJ's ortho clinical diagnostics unit makes blood-screening equipment and laboratory blood tests; it's a small player in a market led by Roche (RHHBY, RHHBF), Siemens (SI), Abbott Labs (ABT) and DHR.
Dec. 9, 2013, 12:22 PM
- Roche (RHHBY -0.8%) says Phase 3 data from a study of GA101 in CLL show patients "experienced nearly a year of extra remission time when treated with GA101 in combination with chlorambucil, compared with MabThera and chlorambucil."
- Median PFS: 26.7 months versus 15.2 months; HR=0.39.
- CR rate: 21% for GA101/chlorambucil versus 7% for MabThera/chlorambucil.
- The company calls the results "unprecedented": "For the first time in a first-line Phase 3 CLL study, we have seen a therapy that shows superior efficacy over MabThera," Roche says. (PR)
Dec. 6, 2013, 4:34 AM
- The annual American Society of Hematology meeting is due to start today in New Orleans, where new treatments for chronic lymphocytic leukemia from Gilead Sciences (GILD), Pharmacyclics Inc. (PCYC), Infinity Pharmaceuticals (INFI), Roche (RHHBY) and others will be a focus.
- Analysts forecast that the drugs will collectively generate up to $9B a year in annual revenue by 2020.
Nov. 27, 2013, 9:38 AM
- Alimera Sciences (ALIM +4.1%) adds to Tuesday's gains as investors cheer final guidance from NICE on Iluvien.
- The move represents a change of heart for NICE — the cost gatekeeper did not recommend NHS support for the DME treatment at its tech appraisal in January.
- In other NICE news, Lucentis (RHHBY, NVS, PDLI) gets a positive recommendation for the treatment of choroidal neovascularisation in people who also have pathological myopia.
- Alimera Sciences (ALIM +4.1%) adds to Tuesday's gains as investors cheer final guidance from NICE on Iluvien.
Nov. 25, 2013, 3:15 AM
- Voters in Switzerland - home to at least five of Europe's 20 best-paid CEOs - have rejected a proposal by a margin of around 2-1 to cap the salary of company bosses at 12 times that of their lowest-paid staff.
- Firms that would have been affected by a yes vote include UBS (UBS), Credit Suisse (CS), Roche (RHHBY), Novartis (NVS), ABB (ABB), Glencore Xstrata (GLCNF) and Nestle (NSRGY).
- The referendum came after the Swiss electorate approved a proposal in March to give shareholders a binding vote on the pay of senior managers.
- ETFs: EWL, FSZ
Nov. 22, 2013, 7:07 AM
- Sanofi's (SNY) and Regeneron's (REGN) Sarilumab injectable antibody for treating rheumatoid arthritis performed well in a Phase III trial of 1,200 patients when combined with the standard oral treatment methotrexate.
- The combo eased symptoms, including pain, improved physical function, and slowed the progression of the disease.
- The study is one of two Phase III trials planned for Sarilumab.
- Analysts estimate that the drug could generate revenue of €579M ($780M) by 2020. It would compete with Roche's (RHHBY) Actemra and potentially with treatments being developed by AbbVie (ABBV), Johnson & Johnson (JNJ) and Bristol-Myers Squibb Co. (BMY). (PR)
- Meanwhile, Regeneron's Eylea has received approval in Japan for the treatment of macular edema following central retinal vein occlusion, a common vascular disease among the elderly caused by a blockage of one of the small veins that carry blood away from the retina. Regeneron is working with Bayer (BAYZF) on non-U.S. sales of Eylea. (PR)
Nov. 20, 2013, 11:33 AM
- Roche (RHHBY -0.4%) and ImmunoGen's (IMGN +1.8%) Kadcyla gets European marketing approval, triggering a $5M milestone payment to IMGN.
- The drug is approved for adults with "HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received Herceptin and a taxane, separately or in combination." (PR)
- The news was expected after the CHMP gave the drug a positive opinion back in September.
Nov. 13, 2013, 8:38 AM
- Roche (RHHBY) signs an R&D collaboration agreement with immatics for cancer vaccines and immunotherapies "targeting primarily gastric, prostate, and non-small cell lung cancer."
- One vaccine candidate covered under the deal, IMA942, is ready for Phase 1 studies.
- immatics gets an upfront payment of $17M and is eligible for milestone payments up to and above $1B. immatics will also receive royalties on any marketed drugs. (PR)
Nov. 7, 2013, 11:48 AM
- Patients taking Roche's (RHHBY) recently approved CLL drug Gazyva lived 26.7 months (median) without disease progression versus 15.2 months for patients taking Rituxan, data from a Phase 3 study show.
- "Given how much benefit Rituxan has provided to patients, it was a high bar to imagine that you could actually improve upon that,” the company's head of hematology tells Bloomberg.
- Here's Adam Feuerstein: "The positive study results will benefit Roche because they validate the development plan for Gazyva, which was to engineer a more potent version of Rituxan [sales of which] could start to fade in 2016 when a biosimilar version of the drug is expected to enter the market."
- 2012 Rituxan sales: $7.16B.
Nov. 6, 2013, 7:20 AM
- The FDA has placed a partial clinical hold on the Phase I trial of Curis' (CRIS) CUDC-427 treatment for advanced and refractory solid tumors or lymphomas.
- The FDA ordered the halt following the death a patient who suffered liver failure a month after discontinuing treatment with CUDC-427.
- Curis won't be able to enroll new patients for the study until it has met various FDA requirements; all the subjects in the trial have stopped taking the drug due to disease progression, or patient or physician discretion
- The company licensed CUDC-427 from Roche's (RHHBY) Genentech.
- Curis' shares sink 10.5%.
- Curis' Q3 results. (PR)
Nov. 1, 2013, 9:32 AM
Oct. 28, 2013, 3:22 PM
Oct. 23, 2013, 11:47 AM
- Is Roche (RHHBY +0.4%) really interested in Alexion (ALXN -0.4%) or BioMarin (BMRN +0.1%)? CEO Severin Schwan isn't telling, but he did say at a Paris conference that the company will "go where the science takes it, wherever it is, independent from the size of the patient population," suggesting a move into rare and orphan diseases.
- Regarding the company's attempt to expand beyond core cancer treatments, Schwan mentioned autoimmune, inflammatory diseases, and neuroscience, noting that in these "three areas naturally [Roche] is a partner of choice for many companies [and] if there was an interesting opportunity outside of those established areas, I would be very open to look at it."
- More on Roche/ALXN speculation here, and on BMRN chatter here
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Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and... More
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