- Pharmaceuticals constitute 69% of the Trefis price estimate for Johnson & Johnson's stock.
- Medical Devices constitute 25% of the Trefis price estimate for Johnson & Johnson's stock.
WHAT HAS CHANGED?
- J&J Covid-19 Vaccine
- The rollout of J&J's Covid-19 vaccine has been off to a rocky start amid concerns of extremely rare but potentially deadly side-effects of blood clots and manufacturing and quality issues at a plant run by a contractor in Baltimore. Demand for the shot has also been tepid in the United States, where Pfizer and Moderna have come to dominate the Covid-19 vaccine market. The manufacturing issues, coupled with low uptake have meant that no new doses of the shot have been distributed to states since the week of May 17, 2021. Moreover, about half of the 21 million doses produced for the United States are apparently unused, per a report from Reuters.
However, J&J is making some progress with its international rollout. The single-dose vaccine was authorized for emergency use by the U.K. regulator in late May and the U.K has ordered 20 million doses of the shot that is likely to be available later this year. J&J will also be supplying the doses to Japan by 2022. Japan has made little progress with its vaccination drive so far, with only 22% of its population fully vaccinated. The company is also looking to expand the vaccine’s availability to India, working with manufacturer Biological E. to produce its shot locally.
Overall, we still think the J&J shot has room for growth globally, as it could do much of the heavy lifting in getting the global population inoculated against Covid-19, considering its single-dose requirement and relatively easy storage.
Now while J&J’s vaccine has dominated the headlines for the company, there is not much upside from a stock price appreciation point of view, given that it is a not-for-profit product, at least for the period of the pandemic.
- Q2 2021 Performance
- Johnson & Johnson reported a solid 27% top line growth in Q2 2021, driven by a large 63% growth in medical devices sales, 17% jump in pharmaceutical sales, and a 13% growth seen in consumer healthcare business. The Medical Devices business in particular has seen a rebound over the recent months after taking a hit in 2020, especially Q2 2020, due to the pandemic. Adjusted EPS grew 48% from $2.48 in Q2 2021 from $1.67 in the prior year quarter.
- Impact of Coronavirus On Johnson & Johnson
- The current coronavirus crisis has impacted pharmaceutical companies on two fronts, 1. impact from hospitals deferring non-emergency and non-Covid cases, resulting in lower number of prescriptions issued, and 2. on direct sales of Medical Devices due to postponement of elective surgeries. Johnson & Johnson has also secured the U.S. FDA's emergency use authorization for its vaccine for Covid-19, which the company intends to sell on a no-profit basis.
- Loss of Patent Exclusivity
- Over the last few years, several of J&J's drugs including Levaquin, Concerta, Invega, and Aciphex lost their patent protection. Its blockbuster drug Remicade, which generated revenues of close to $7 billion in 2016 lost its patent exclusivity, and now faces competition from Pfizer's biosimilar drug - Inflectra. Remicade sales declined to $3.7 billion in 2020. We forecast a mid-teens decline in the near term, as Inflectra hasn't seen significant uptick since its launch. Over the next few years, about 3-4 drugs are expected to lose their patent and this will impact J&J's overall revenues.
- Oncology Drugs Driving The Growth
- J&J has made some great strides in the pharmaceutical sector over the last few years. The company, traditionally known for medical devices and diagnostics, has now becoming more centered around pharmaceutical business. Within pharmaceuticals, Oncology has led the company's growth in the recent past, and this trend will likely continue. Its key drugs includes Darzalex, Imbruvica, and Zytiga, with combined sales of $12.4 billion in 2020.
- Late Stage Pipeline
- J&J has a robust pharmaceutical pipeline, which will contribute meaningfully to its top line over the next 3-5 years. The top drugs in the phase 3 pipeline include oncology drugs such as Amivantamab, Lazertinib and Niraparib, anti-infective drugs such as Pimodivir, and neuroscience drugs such as Ponesimod and Seltorexant. Peak sales of these drugs is estimated to be north of $8 billion. After a strong run up in the past few years, J&J’s fast growing pharma business has started to slow down, partly due to patent losses. Therefore, the company is banking on these phase 3 pipeline drugs to drive growth going forward.
POTENTIAL UPSIDE & DOWNSIDE TO TREFIS PRICE
Below are key factors that present opportunities for upside or downside to the current Trefis price estimate for J&J:
Phase 3 Pipeline Fires
- J&J's Oncology Drugs Revenue and J&J's Anti-Infective Drugs Revenue: Despite the fall of J&J's hepatitis C drug Olysio, there still exists some potential in its pharma business that can be unlocked. Its immunology and oncology drugs can do well although Remicade is facing competitive challenge from biosimilar Inflectra. Other immunology drugs such as Simponi and Stelara are growing fast. Stelara has grown at average annual growth rate of 25% over the last 3 years. J&J's new immunology drug Tremfya was approved in 2017, and is expected to garner over $2.5 billion in peak sales. J&J’s oncology division is likely to do very well, primarily led by Imbruvica and Darzalex. Both these drugs combined should generate sales of over $9.5 billion in 2021. We have factored in these expectations in our price estimate. However, positive data pipeline drug trials could lead to our forecasts being conservative. For instance, there are additional clinical data that could potentially strengthen Imbruvica's sales going forward. Also, the company is likely to file multiple phase 3 drugs for FDA review in the coming years. Our valuation reflects probability adjusted revenues assuming 50% chance of phase 3 drugs reaching commercial stage launch. There are more than 10 drugs in phase 3 pipeline with total estimated peak sales of over $8 billion. If all phase 3 drugs are approved within next 3-4 years, it could add additional $4 billion in total revenues by the end of our forecast period. This could lead to an upswing of over 5% in J&J's stock price.
Phase 3 Pipeline Fails
- J&J's Immunology Drugs Revenue, J&J's Oncology Drugs Revenue and J&J's Anti-Infective Drugs Revenue: Our valuation of phase 3 drugs incorporates 50% probability of phase 3 drugs reaching commercial launch stage and therefore, our revenue forecast includes probability-adjusted revenue for these drugs. Neuroscience, immunology, anti-infective and oncology drugs together account for 40% of our price estimate for Johnson & Johnson. If any issues plague JNJ's phase 3 drugs and the company is unable to achieve FDA approval for them, it could imply 10% downside to our price estimate.
Medical Devices Business Crumbles Under Competitive Pressure
- J&J's Orthopedics Devices Revenue and J&J's Surgical Devices Revenue: The revenues from J&J's medical devices & diagnostics segment have declined in low-single-digits on average over the last 5 years. It remains to be seen if J&J can sustain the revival that initiated in 2016 after falling from peak in 2013. Competition from new players has led to pricing pressure, which has brought down incremental growth despite increased shipments. We currently expect low growth in medical devices and diagnostics business. However, if the competition intensifies and J&J fails to find new growth drivers, its revenues can dip further by $5-$6 billion leading to approximately 10% downside.
Johnson & Johnson (NYSE:JNJ) is an American multinational pharmaceutical, medical devices and consumer packaged goods manufacturer founded in 1886. The company (also called J&J) and its subsidiaries are engaged in the research and development, manufacture and sale of a range of products in the health care field. It has more than 250 operating companies conducting business worldwide.
J&J is an industry bellwether and therefore its shares generally reflect the overall performance in healthcare products at any given point in time. It also reflects investor appeal for “defensive” securities, as during periods of economic or market uncertainty investors have generally sought haven in J&J shares as its earnings are less cyclical.
SOURCES OF VALUE
We believe that both pharmaceuticals and medical devices business are important to J&J's value.
Pharmaceuticals Business Has Grown Significantly In The Past Few Years
J&J's pharmaceutical business accounted for nearly 55% of its revenues in 2020. The contribution of pharmaceuticals has increased over the last few years, thanks to the growth in immunology, anti-infective and oncology drugs. Besides, the division has significantly higher EBITDA margin (~ 50%) as compared to consumer business, and medical devices segment. J&J also acquired a Swiss Pharma company - Actelion - in 2017 for $30 billion. This has further improved its top and bottom line.
Strong Market Position In Medical Devices Industry
J&J has leading market position in several sub-segments of the medical devices market due to its diversified product offerings, established brand, R&D focus, and strong sales and marketing capabilities. Medical devices business constituted roughly 28% of total revenues and 21% of total EBITDA in 2020. Furthermore, J&J acquired Synthes in 2012, which is a global manufacturer of medical devices for orthopedics market including trauma and spine. The combined DePuy/Synthes orthopedic division has the broadest orthopedic portfolio globally and will help J&J expand its leadership.
Pharmaceutical Business Becoming Increasingly Important
J&J has made some great strides in the pharmaceutical sector in the last few years. The company, traditionally known for medical devices and diagnostics, is now becoming more centered around pharmaceutical business. The segment saw strong growth driven by increasing sales of Remicade, Zytiga, Simponi, and Stelara. However, there are near term challenges as Remicade faces competition from Inflectra and Invokana and Xarelto face pricing pressure. Much of the future growth is likely to come from oncology drugs such as Imbruvica and Darzalex. In addition to this, J&J's pipeline will contribute meaningfully in the next 5 years.
Loss of Patents Impacting Sales
Over the last few years, several of J&J's drugs including Levaquin, Concerta, Invega & Aciphex lost their patent protection. Over the next few years, about 3-4 drugs are expected to lose their patent and J&J will need to develop new drugs to offset these losses.
Growing Threat of Generic Products
The fast growing pharma market in emerging economies or referred to as the 'Pharmerging' economies have the capability and technical prowess to manufacture generic versions of blockbuster drugs. These generic drugs are often sold at prices that substantially cheaper than their branded counterparts, thereby severely affecting big pharma's ability to generate profits in the long run. Remicade faces potential threat from biosimilars, which are generic versions of biologics. The drug is already witnessing significant sales decline in Europe where its biosimilar versions have been approved. However, J&J holds marketing rights for Americas, Japan and other regions. If a biosimilar version of Remicade is approved in the U.S., Remicade's sales, attributable to J&J, will suffer.
Globalization of Healthcare Reforms
Governments around the world are trying to rein in fiscal spending in order to manage their budget deficits
Since healthcare costs are one of the biggest components of any national budget, increased healthcare legislation and reforms around the world will hurt revenues for the entire pharmaceutical sector.
Piling Lawsuits Against Consumer Healthcare Products
Johnson & Johnson was recently ordered by a jury in Missouri to pay $550 million in compensation and an additional $4.14 billion in punitive damages, in a case related to its talc products. The company was previously able to get a relief in a similar case last year, where a woman alleged that she developed ovarian cancer after using J&J’s talc products, and the company's management in its Q2 2018 earnings conference call stated that it is positive to get the verdict reversed. However, the amount of $4.7 billion set by the jury is very high, and pertains only to this case of 22 women. There are over 9,000 lawsuits against J&J for its talc products, including the baby products. The company on an average has spent $1.5 billion dollar on litigation expenses between 2015 and 2018. The company spent $4.3 billion in litigation expenses in 2019, primarily to settle opioid lawsuits. In 2020, the company spent $5.1 billion in litigation expenses. If these expenses were to increase, it could hurt the company's earnings growth.