AbbVie: Modeling the Post-Humira Slump to 2030 (ABBV) (2023)

investment overview

Since its split from Abbott Laboratories (AB) in 2012 AbbVie (NYSE:ABBV) delivered strong returns for investors: the share price rose from $30 to $149 per share at the time of theWrite - Trading slightly below its all-time high of >$160 set in early December last year.

In addition to the stock gains, AbbVie has always paid a good dividend, which is up 270% since Pharma's inception and currently pays $1.48 per quarter for a current yield of 4%, the highest ever in the big pharma industry was recorded.

AbbVie's success, as its shareholders no doubt know, is due to the huge success of its immune drug Humira, which is indicated for a variety of autoimmune diseases, including rheumatoid arthritis, psoriatic arthritis, psoriasis, Crohn's disease, ulcerative colitis, hidradenitis suppurativa, and spondylitis ankylosing .

Sales of the drug reached $19.9 billion in 2018 and totaled $19.2 billion, $19.8 billion, and $20.6 billion in 2019, 2020, and 2021, respectively. By 2022, Humira's sales are expected to top $21 billion, taking the drug past cholesterol-lowering Lipitor to become the best-selling drug of all time.

AbbVie is led by CEO and President Rick Gonzalez, arguably AbbVie's sole pharmaceutical CEOdo not have a university degree- who successfully defended Humira against generic competition by pursuing a controversial strategy of constantly filing new patents related to minor changes in manufacturing or delivery methods, often referred to as a "patent maze".

Without the additional patents (>130 total), the Humira would have lost its market exclusivity in 2016, but ultimately lost protection in Europe, causing sales to drop from $6.3 billion in 2018 to ~$2.7 billion Dollars in 2018 would have led to generic competition in the US since earlier this year.

Any company is likely to struggle when sales of its top-selling asset are declining at about 20% per year, which is traditionally the rate at which sales of expired patent drugs are being phased out, but when the drug in question accounts for >35% of a company's sales, such as Humira does, the situation becomes even more serious.

Luckily for AbbVie shareholders, González and his management team had many more years than expected to prepare for Humira's loss of exclusivity ("LOE"), and Pharma never had any ambitions to build its business on a single moment, but it did defeats everything. - limited medication.

Today's AbbVie has 5 thriving businesses: Immunology, Oncology, Neuroscience, Aesthetics and Ophthalmology, the last 3 of which were acquired from Allergan as part of AbbVie's $63 billion acquisition of that company.

By 2022, the company is likely to have 12 blockbuster sales facilities (>$1bn/year) that will collectively generate ~$48bn in sales, with Humira being the only drug with its patent expiring soon, while AbbVie at least 6-7 promises major new product launches by 2026.

While the company acknowledged that 2023 earnings are likely to decline in 2022 (last year's guidance is for earnings per share ("EPS") of $13.84 to $13.88 on an adjusted diluted basis, versus 12, $7 in 2021), González and his team made some bold promises to investors at this year's JP Morgan Healthcare conference. The CEO commented in a chat during the conference:

We remain well positioned to absorb the impact of Humira LOE and quickly return to strong growth from 2025 onwards. We continue to expect a clearer path to strong revenue growth in 2025 with a single digit CAGR by the end of this decade.

Investors don't seem to be taking the bait, however, as AbbVie's stock price has fallen more than 7% over the past month and more than 5% in the past 5 days.

However, with detailed guidance and management feedback on sales performance of key assets and new product launches, I've completed AbbVie's 2030 sales projections that I'll be sharing in this post, highlighting areas of strength and potential weaknesses.

I will also present a forward-looking income statement and discounted cash flow analysis that suggest AbbVie stock's current value should be trading at just $176, meaning the stock is currently up as much as 18% of its current value true value is discounted.

AbbVie's post-Humira LOE plans aren't risk-free, and their goals are ambitious, but still, I see no harm in buying pharma stocks at current prices, accepting a generous 4% dividend, and likely from the share buyback and that Stock price growth to benefit through 2030.

Below, I summarize how I believe AbbVie is strongly supporting Humira's LOE and driving the high-single-digit annual growth that management has promised.

AbbVie by 2030 - Surpasses Humira LOE - Department of Immunology

Let's start our discussion with the Department of Immunology.

As we can see, the Immunology business consists of only 3 assets, but by my calculations it will probably account for 50% of AbbVie's sales in 2022 (to calculate 2022 sales by product as we don't have the numbers yet) . I used 9 million numbers from 2022 and assumed fourth quarter sales will be in line with the average of the previous three quarters.)

After 2022, the Humira line is shaded yellow to indicate patent expiration. My estimate is that Humira's 2023 revenue will be 80% of its 2022 value, or $16.7 billion. AbbVie CEO González told the audience at the JPM Healthcare conference:

We now have just over 90% access over the next year for Humira at face value. That means you're essentially fine with biosimilars, but there won't be any difference between the biosimilar and the Humira in terms of co-payment or any processing steps.

Most Humira biosimilar knockoffs (high-end generic versions) that will compete with the original for market share will hit the market in mid-2023, includingdeveloped versionsby Pfizer (PFE), Boehringer Ingelheim, Organon (OGN), Biocon, Coherus Biowissenschaften (CHRS) and Sandoz, while Amgen (AMGN) Amjevita is allowed to appear in January.

The important point here is that physicians will not necessarily be under pressure to switch patients from Humira to a biosimilar because, as González says:

There will be no difference between the biosimilar and the Humira in terms of co-payment or any processing steps.

However, AbbVie will have to lower its price to compete with generics, and it won't capture 10% of the market, so an overall 20% sales decline in 2023 seems about right. In my model, I reduced sales by 20% between 2024 and 2026, and then by 10% per year between 2027 and 2030.

In short, Humira may lose its patent, but it is more than capable of generating double-digit billions of dollars in revenue for another 3-4 years, and even by 2030 it could be among the top 20 selling drugs worldwide. .

However, AbbVie is clearly under a lot of pressure to defend its dominance in the immunology markets, and there are signs it has succeeded thanks to the launch of two new drugs: Skyrizi and Rinvoq.

Of course, if a more effective and safer drug than Humira is available for the same indication, doctors will likely prescribe it instead of Humira or a biosimilar to Humira. Skyrizi, which inhibits the activities of IL-23, a natural cytokine involved in inflammatory and immune responses, and Rinvoq, a member of the Janus kinase inhibitor class of drugs, fit this profile.

As we can see above, both Skyrizi and Rinvoq have already been approved for all Humira indications with the exception of hidradenitis suppurativa, although Rinvoq is being investigated in this indication.

The development of these two drugs was very rapid by drug development standards, and to date both have performed exceptionally well. Combined sales are expected to reach $7.5 billion in 2022 and González told the audience at JPM:

Skyrizi and Rinvoq are now on track to achieve combined risk-adjusted revenue of more than $17.5 billion in 2025, well ahead of our previous expectations. We now project Skyrizi's global sales to exceed $10 billion by 2025, an increase of $2.5 billion from our previous guidance, reflecting stronger performance across virtually all indications.

Looking beyond 2025, we expect combined revenue from Skyrizi and Rinvoq to exceed Humira's peak revenue of over $21 billion. We assume that this will happen in 2027 and that further significant growth is expected in the years to come.

So without Humira no problem! Skyrizi and Rinvoq together will generate higher peak sales than Humira could ever match, although Humira continues to be a significant contributor and still accounts for 7% of AbbVie's total sales in 2030.

Skyrizi-Temdemonstrated superioritycompared to Humira in areas such as plaque psoriasis at a statistically significant level with a comparable safety profile, while Rinvoq, for example, was superior in psoriatic arthritis at a lower dose with a similar safety profile and was also approved in an area where Humira does not, namely atopic dermatitis.

It should be noted that the stiff competition AbbVie faces from other drugmakers keen to capture a larger share of the immunology markets after Humira's LOE is fierce: from Eli Lilly (LLY) Olumiant, Pfizer (PFE) Zeljanz, Otezla de Amgen, Bristol Myers Squibb (BMY) Zeposia, Johnson & Johnsons (JNJ) Tremfya, Novartis (NVS) Cosentyx und Regeneron (REGEN) / by Sanofi (CUT) Dupixent, just to name a few.

However, it's hard to argue against Skyrizi and Rinvoq's past performance, and with the total addressable market for all immunology indications projected to exceed $100 billion, I'm pretty confident that AbbVie can grow sales in this division, even if it does it is the largest in sales in the world. Damn leaves the stage on the left.

Oncology - Strengthening a declining hematology division and entering solid tumor markets

AbbVie probably doesn't just want to be recognized as an immunology giant; however, it plans to become significantly more diversified and, like all big pharma, has a strong long-term focus on oncology.

One of the few pain points AbbVie experienced in a year of broad-based portfolio growth in 2022 was the decline in sales contribution from Imbruvica, which is approved to treat multiple types of lymphoma. Management originally blamed slow post-pandemic uptake for the drug's sales decline, but Gonzalez also told attendees at the JPM conference that "competitive new entrants have significantly lowered our sales expectations for Imbruvica."

As a result, I've pared Imbruvica's revenue to just over $3.5 billion in 2022 and calculated it's CAGR growth of just 1.5% through 2030. That certainly won't derail the oncology division, though. Venclexta, a "first-in-class BCL-2 inhibitor for multiple hematologic malignancies," is forecast for strong growth, according to González, while González has name-reviewed 3 new drugs that he expects to be approved by 2026.

The first is epcoritamab, a CD3xCD20 bispecific for B-cell malignancies including DLBCL and follicular lymphoma, which AbbVie expects to receive approval this year. Analysts have suggested that the drug will reachsales peakof $2.75 billion, and while the emergence of CAR-T therapies and some safety concerns remain, particularly cases of cytokine release syndrome ("CRS"), I believe that sales number is achievable.

The next two government approvals for Navitoclax in myelofibrosis and Teliso V in non-small cell non-squamous cell lung cancer ("NSCLC") are planned for 2024.

Myelofibrosis has proven to be a difficult indication for drug developers and there are currently no fully satisfactory solutions on the market; As such, I expect Navitoclax, a drug AbbVie has been working on for some time, to generate a few billion dollars in peak sales if approved.

Telisa V is an antibody-drug conjugate and c-Met inhibitor. Other approved ADCs targeting the c-Met protein, a validated target in the NSCLC, include Novartis Tabrecta, which has been set for peak sales of around $1.5 billion, a realistic target given the size of the lung market Teliso seems to be Cancer: the biggest. all oncology markets.

Since AbbVie seems very confident in the approval of these 3 drugs and González suggests that they could form the basis of a "$6 billion franchise type", I have modeled such an outcome by 2030. But AbbVie is also interested in studying tumors. solid, and so I'm adding another $1.5 billion in revenue from this source through 2030. That number could end up being much higher, according to González:

We're starting to see some very interesting data from multiple solid tumor programs, including our anti-GARP antibody, ABBV-151, and our PTK7-ADC, ABBV-647. We anticipate proof-of-concept data from approximately a dozen additional early-stage oncology opportunities over the next two years.

In summary, while AbbVie doesn't have the same impact in oncology and immunology as Imbruvica's sales decline may indicate, it is clearly an area of ​​focus for management. Traditionally, drug development has not been one of AbbVie's strengths, nor has it had to be, but we should see positive results from the heavy investment in the oncology channel over the next 5-7 years and by 2030 I think this business could be represented >17 % of AbbVie's total revenue.

In line with management guidance, I'm projecting sales of $5.7 billion in 2023, with growth accelerating significantly from 2025-26.

Aesthetics and Neuroscience: Realize the benefits of the Allergan acquisition

AbbVie made the bold decision to take on massive debt and bid on Allergan, with the transaction closing in 2020. Allergan was a struggling company in many ways, but the strength of its products and portfolio is unquestionable. According to CEO Gonzalez:

In the longer term, aesthetics remains an extremely attractive, under-penetrated market with significant potential for growth. And we remain confident that we can achieve more than $9 billion in combined sales by 2029.

So I modeled it similarly, although I included an additional revenue stream for new products, which I expect will be smaller but will ultimately contribute an additional $1.5 billion in sales. Risks associated with aesthetics are that the industry can be severely affected by economic headwinds as these products are more consumer-centric and are often viewed as wasteful spending during tough times.

Neuroscience is one of the most fascinating departments at AbbVie and perhaps the most difficult to model. Management is very optimistic about Vraylar, with Gonzalez describing it as "now the only antipsychotic that is a dopamine and serotonin partial agonist approved for the treatment of the most common forms of depression, bipolar 1 and MDD," and high Aiming for sales in excess of $5 billion. The Ubrelvy migraine therapy is a future success, González believes, as does Qulipta in the same indication.

Duodopa is approved for Parkinson's disease, but Gonzalez believes the non-surgical subcutaneous delivery system for candidate ABBV951 "could significantly expand the patient population that Duopa is currently targeting" and sees the drug as another future blockbuster. Targeting Alzheimer's disease, ABBV-916 is an anti-amyloid antibody with a similar mechanism of action ("MoA") to the recently approved Leqembi developed by Biogen (BIB) / Eisai and donanemab, developed by Eli Lilly, are likely to be approved soon.

Both Leqembi and donanemab have potential sales assets of $5 billion to $10 billion, but both drugs still have safety questions to be answered and there is no certainty that they will qualify for reimbursement. ABBV-916 is therefore a real opportunity for AbbVie to develop a more effective and safer drug in the same class and capture a significant market share of 6 million patients. I have speculatively credited peak sales of $2 billion, noting that success is far from guaranteed here, although if AbbVie were successful with the ABBV916, sales could be 2-3 times higher than my prediction.

Eye care, other products, and a dwindling women's health department

Finally, eye care, another business acquired from Allergan, has done well for AbbVie, although I don't expect to see particularly strong growth from the current product portfolio. What's intriguing here is the possibility of RGX-314, an anti-VEGF gene therapy that González believes has "the potential to be a unique treatment for wet AMD, diabetic retinopathy, and other chronic retinal diseases."

Gene therapies have been around for a long time and became popular in the early 1990s. There are still very few approved therapies, although that could change with Crispr Therapeutics (CRSP) / vertex (VRTX) Sickle cell disease therapy will take the lead in 2023. The obvious benefits of a permanent "instantaneous" cure make these therapies potentially very profitable.

The eye disease markets are very large: Regeneron's Eylea is a drug that sells over $7 billion a year, and AMD's markets are over $20 billion. The launch of the RGX314 would be a blow to AbbVie, although I'm forecasting a sales spike of just $2 billion in 2030 as a hedge against the risk that this candidate doesn't make it to market for security reasons.

Other products like Mavyret and Creon appear to have many years of box office sales ahead of them, although it's interesting to note that AbbVie no longer reports earnings from its women's health division and rarely mentions it. Perhaps this is an example of how adamant management can be in the face of declining sales, and a warning that not all areas of the company are guaranteed to be successful.

P&L modeling and DCF/EBITDA multiple analysis

First, we can take a quick look at what AbbVie's future earnings statement would look like through 2030. I have included my revenue expectations in this table, knowing that they reflect AbbVie management's own expectations based on public statements.

My EPS number will increase slightly between 2022 and 2023, while AbbVie has indicated it will decline slightly before starting to increase towards the end of the decade as earnings pick up sharply after Humira's worst LOE.

I expect AbbVie to grow revenue at a ~5% CAGR through 2030, with accelerating growth in the second half of the decade. That's significantly higher than the 12% CAGR achieved between 2018 and 2022, even though that period includes Allergan's incremental revenue. AbbVie doesn't have the resources to pursue large M&A deals, but given the strength of its portfolio and products, it doesn't need to.

Finally, I can provide a price target for AbbVie stock in 2023 using DCF/EBITDA analysis. I use a weighted average cost of capital of about 10%, which is broadly consistent with the value I use when modeling for the other 7 members of what I call the "Big 8" US pharmaceutical companies: Johnson & Johnson, Eli Lilly , Pfizer , Merck & Co (MRK), Bristol Myers Squibb, Amgen und Gilead Sciences (BRAUN) - which helps to test the accuracy of the calculation.

With AbbVie having over $80 billion in revenue by 2030 (by my calculations) and generating >$25 billion in cash flow that year, I have a price target of $176 each year after applying discount factors achieved - average DCF - $162 per share - and EBITDA - $189 per share - calculations.

Some risks to consider

The big pharma sector has performed remarkably well in 2022, with the "Big 8" posting an average gain of ~15%, while the S&P 500 index fell and the biotech sector was in turmoil. Not only do these companies pay good dividends, but each year they typically grow their sales and generate large profit margins, which causes their stock price to rise.

This makes companies like AbbVie generally very attractive to investors, although it should be noted that AbbVie has very high levels of debt, which totaled over $60 billion in Q3 '22, which is roughly the amount the company has for paid for the acquisition of Allergan.

AbbVie says it will repay $4 billion of debt in 2023, which "will reduce accumulated debt payments by about $34 billion," but the company relies heavily on an investment-grade rating to maintain. The company is currently in a “stable” situationclassification, but this must be maintained or investors will find the company unsafe to invest in, which will quickly drag the stock price down.

Medicines are often valued according to the philosophy of 'morning jam' rather than today's jam, ie according to their future portfolio rather than the present. That comes with some risk, as clinical trial failures are common even at a giant like AbbVie, and even CEO Gonzalez could be forced to retract some of his blockbuster sales forecasts. As with debt, missing approval and revenue targets can quickly lead to a loss of trust in the company.

Drug prices are another concern: There is bipartisan and international pressure on US drug companies to reduce drug prices, particularly outside the US. González vigorously defended AbbVie against allegations of fraud. their powerful lobbyists will weaken in the face of external pressure, and the industry will once again appear unattractive to investors.

Bottom Line: Humira's LOE won't stand in the way of this company's strong progress: I predict steady stock growth through 2030

I'll conclude this review by stating that based on all available information, market headwinds, market headwinds, competitors and opportunities through their products and portfolio, I continue to believe that AbbVie is a great investment opportunity.

The company may not garner as much attention as some of the other "Big 8" members, most notably Eli Lilly and its weight-loss franchise, but the path to revenue growth, margin expansion, and stock price appreciation is clear. .

Investing in AbbVie isn't risk-free, but I believe this pharma industry is in good hands (CEO González has made few mistakes during his nearly 10-year tenure) and Humira LOE will emerge as a stronger and more diversified company.

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I write about biotech, pharmaceutical and healthcare stocks and share investment advice. Find me on my marketplace channel Haggerston BioHealth: Model Portfolio + 4 exclusive stock picks each week. I'm on Twitter @edmundingham