- While investors have long criticized Mylan’s new product yield, a generic Advair and Restasis could finally be coming to market before the end of the year.
- In terms of recently launched drugs, gCopaxone has had a slow start but could be starting to pick up. Fulphila continues to do well, and Yupelri was approved by the FDA earlier this month.
- 3Q outperformance was helped in part by strong margin expansion due to new product launches and continued integration efforts
- Mylan still has issues, including a difficult generic environment and the ongoing Morgantown remediation. However, expectations are low, and the risk/reward could be favorable
Read More- The story around Johnson and Johnson consists of three components: an eroding piece (Zytiga and Remicade), a growing piece (numerous new drug launches and line extensions), and a turnaround effort in its Consumer and Medical Devices segment
- Within the eroding piece, Remicade, Zytiga, Concerta, and Velcade face ongoing competition and loss of exclusivity that could impact sales. Invokana has also struggled.
- However, management is optimistic that an extensive pipeline of new drug launches and line extensions can offset the declines. Stelara, Tremfya, Erleada, and Esketamine are most often discussed by investors.
- Outside of the Pharmaceutical segment, management is focused on turning around the Consumer and Medical Devices segments. Results from 3Q showed that these efforts were beginning to see returns.
Read More- Expectations were low for COAPT due to disappoting results from MITRA-FR. However, some analysts still believed COAPT was different enough to see a more positive outcome
- These analysts were right. COAPT results were overwhelmingly positive; both primary endpoints were met, as hospitalization and mortality saw significant reductions
- Results should provide a boost to ABT stock on Monday and positive read through to other companies pursuing transcatheter mitral valve repair
Read More- Eylea represents a significant portion of revenue and will face upcoming competition, which could slow Regeneron sales growth over the coming years
- Eylea recently received approval for a 12 week dose, but with cautious language on the label, leaving the door open for competitors to potentially take share when they enter the market.
- Dupixent is a promising asset that could drive growth after Eylea, but will need to get past reimbursement issues and execute on indication expansions to stay ahead of competition.
Read More- MITRA-FR results in late August missed primary endpoints and was incrementally negative for MitraClip’s prospects at expanding into the functional mitral valve regurgitation indication
- However, numerous experts and analysts continue to believe that Abbott’s pivotal COAPT trial could still see success on 9/23 as the trial design differs in several key aspects
- Elsewhere, the company continues to see strong organic revenue growth, and its CGM device, Libre, is outperforming expectations
Read More- Initial data points on prescription trends for Aimovig suggest a strong launch for the drug and for the anti-CGRP class.
- Amgen faces upcoming biosimilar competition for Neulasta, but also expects its own portfolio of biosimilars to continue to develop. This includes Amgen's Humira biosimilar, which will launch soon in the EU.
- Amgen recently filed an sNDA for a once-weekly Kyprolis dose in combination with dexamethasone. The drug continues to track towards a $1-2 billion drug by 2022.
Read More- Celgene trades at a discount because its key drug, Revlimid, faces potential generic competition prior to the expiration of its patents in 2023.
- Investors and analysts have studied the patents and see a potential path to generic entry between 2020 and 2023. The case/settlement will likely hinge on dosing patents.
- Separately, Otezla continues to perform well for Celgene and has a number of catalysts for the remainder of the year that could drive further upside.
- Other tidbits include continued advancement of CAR-T programs, fedratinib NDA submission in 2018, and ozanimod filing in 1Q19.
Read More- AbbVie's Humira represents a sizeable portion of revenue, and will see biosimilar competition soon in the EU and in the US
- In the EU, a more biosimilar-friendly environment (net of regional differences) and the launch of at least three biosimilars could lead to more significant declines than expected.
- In the US, competition is not expected until 2023, and biosimilars have not gained much traction to date. However, the environment is changing.
- The pipeline looks promising with numerous label expansions planned that could offset Humira sales declines. Some investors are skeptical over whether it will be enough.
- Ultimately, the lack of visibility on Humira's growth trajectory prevents most of the street from turning more positive. 4Q18 Humira performance will be closely watched.
Read More-With Musk ending his attempt to take Tesla private, focus will shift to potential SEC enforcement, which I believe will consist of a fine but no removal of Elon Musk
-Enforcement could hinge on whether Musk had intent to mislead investors with his tweets, which is a high bar to prove
-This is further supported by BP's oil spill, which involved disclosures that misled investors and a subsequent $525 million fine over three years, but no executive removal
-Despite these considerations, we still cannot rule out that the SEC will pursue a harsher punishment given the unprecedented nature of the disclosures
Read More- GSK's 2-drug regimens are seen as potential threats to Gilead's HIV portfolio given the cost and safety benefits. However, sell-side experts and key opinion leaders remain unconvinced.
- Investors are also concerned about the recent slew of management departures, which could put the stock in near-term limbo and delay turnaround progress
- Other discussions include HIV strength, HCV stabilization, Yescarta's longer-term upside, and potential outcomes from upcoming readouts for filgotinib and NASH trials
Read More- Alkermes has three key catalysts ahead for the company that will significantly alter the perceived value of the company
- For ALKS5461, most investors do not see an approval on first pass, which might present an attractive risk/reward profile ahead of the announcement
- For ALKS4230, phase 1 dose escalation data should provide visibility into the potential of the drug (with many investors viewing it as high)
- For ALKS3831, there is a more balanced debate about what weight gain data might be shown in its phase 3 readout in 4Q18
Read More- Diabetes growth should be driven by Trulicity and Jardiance, although both face upcoming competition from Novo Nordisk's oral semaglutide. Trulicity also faces competition from Ozempic that has shown superior clinical efficacy.
- REWIND readout expected in 4Q18 could alter Trulicity's expected growth trajectory significantly (positively or negatively) and has been a heavy topic of debate among investors. Investors increasingly doubt the likelihood of a CV benefit given trial design concerns.
- Other developments include upcoming pain franchise catalysts and the divestiture of the Animal Health business, which could generate funds for additional M&A.
Read More- Analysts are overwhelmingly bullish on Match with the recent pullback from Facebook's upcoming dating feature. Analysts see a large market with room for multiple players to succeed, and numerous other reasons for optimism.
- Match has a number of growth drivers that should provide upside to the stock. The company remains in the early innings of monetizing its significant user base, and will also grow internationally.
- Several risks exist, including the risk that Facebook's curated approach succeeds and dents Match's growth trajectory. There is also headline risk once Facebook announces more detailed plans in the dating space.
Read More- Reata's bardoxolone molecule holds the potential to impact numerous kidney diseases due to its fundamental mechanism of action in reducing inflammation and enhancing energy production in the cell.
- Reata's trial results studying bardoxolone's impact on Alport Syndrome were a strong counter to the bear thesis on hyperfiltration and safety, which had lingered for some time.
- Upside for the stock lies in the potential for bardoxolone to impact several other rare kidney diseases. Bardoxolone has now been validated by numerous trials.
- Risk lies in the early stage of several studies, small sample sizes, and high investor expectations.
Read More- Allergan announced positive topline results for abicipar, its treatment for wet age-related macular degeneration. However, the stock did not react well to the announcement
- Investors were hoping for a lower inflammation signal but saw a higher-than-expected incident rate. Focus now shifts to the company's phase 2 MAPLE study which looks at a reformulation of the drug.
- Beyond the inflammation signal, abicipar could come up against further competition from a 12-week dose from Eylea and upcoming biosimilars for Lucentis. The revenue opportunity remains potentially significant though if Allergan can reduce inflammation.
Read More- Biogen recently announced positive results from BAN2401's phase 2 trial that showed the potential to be the first disease-modifying drug on the market.
- Our current understanding of the underlying mechanisms of Alzheimer's Disease (AD) suggests that the removal of amyloid beta accumulation could slow the progress of AD. BAN2401 fits within this category.
- Investors and AD experts are debating the interpretation of the results. Study design and magnitude of the effect is in question, but overall results provide further validation of amyloid hypothesis. If successfully approved, the drug could generate $5+ billion in revenue.
- To better assess the odds of success, investors should look for more detailed BAN2401 results at the AAIC and monitor other drug developments for further validation, including aducanumab and crenezumab. Biogen also has another AD drug, elenbecestat that will be presented at the AAIC conference.
Read More- Allergan is under pressure from activist shareholders and other investors to formulate a clear strategic plan and make more drastic changes to the company
- Botox Aesthetics, Botox Migraine, and Restasis will all face upcoming competition which could hamper sales growth
- Critical catalysts are approaching that could materially change whether the company makes more drastic changes or not. Expect important readouts from ubrogepant, abicipar, and rapastinel over the next six to nine months
Read More- The primary debate is whether Pfizer can grow sales at mid-single digit growth rates into the next decade despite a growing number of loss of exclusivity headwinds.
- Notable revenue headwinds include upcoming Lyrica competition, Enbrel declines outside of the US, and sterile injectables (SIP) supply issues.
- Label expansions will be crucial to drive above-consensus growth. Key drugs that are often-cited include Ibrance, Xtandi, and Xeljanz. Biosimilar growth and resolution of SIP issues represent another potential area for outperformance.
- Recent spat with Trump largely seen as a non-issue among investors.
Read More- Fremanezumab Chronic Cluster Trial Failure Seen as Non-Issue, but Cluster Pathway Still Unclear
- Copaxone Has Proven More Resilient than Expected, but Longer-Term Outlook Remains In Question
- ProAir Competition Delayed; Estimates Move Up
Read More- Management set long-term financial targets at their Investor Day in early June, and investors are primarily focused on the 4%+ organic growth rate target. Diabetes is the only segment that management is calling for above-corporate level organic growth rates, and is therefore a key part to the company achieving its targets
- Medtronic recently provided an update to its Diabetes growth plan at the American Diabetes Association conference. The company expects the CGM market to grow rapidly, and provided a plan to fill several gaps in its CGM device
- The 670G continues to be the gem within the company's Diabetes segment and will be the primary driver of growth. While competition is heating up in the race for an artificial pancreas, MDT plans to stay ahead and will begin 690G trials soon.
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