A deep dive into the unmet need, competitive landscape and future of treatment:
Obesity primer:
• Defined as BMI >30kg/m^2
• >750M patients globally, including ~40% of US adults --> expected to increase to 1B people / ~50% of US adults by 2030
• Linked to 1/5 US adult deaths
However, just ~2% of people (15M) are on anti-obesity medications (AOM)
Obesity is the leading risk factor for diabetes & other metabolic diseases
For years, bariatric surgery was the primary interventional treatment (25-30% weight loss) as opposed to 1st gen drugs (5-8% weight loss)
Emerging therapies have closed this efficacy gap
Beginning with Wegovy's approval ($NVO) in June 2021, the AOM market has taken off
The TAM is estimated to be >$30B, with new launches expanding the market rather than cannibalizing share
Below chart shows consensus sales est. for Wegovy & Mounjaro to 2027
A key driver of growth has been viral social media videos
Stats across notable platforms: #Mounjaro: >1B views #Wegovy: >200M views
This has driven off-label usage for Mounjaro, which is not yet approved for obesity ($LLY stated ~33% of scripts are diabetes-naive patients)
Also driving off-label use has been an ongoing supply shortage of Wegovy due to manufacturing issues
$NVO said they have enough supply to re-launch all doses & meet 2023 demand, but there are concerns about a FDA warning letter & shutdown of their CMO Catalent's Brussels site
Looking at the landscape, $LLY and $NVO are the market leaders, but a few next-gen agents are in early-stage trials, including $AMGN's AMG-133
Given the disease complexity & patient heterogeneity, it's likely this market gets stratified by severity, comorbidities and biomarkers
As the space gets increasingly crowded, differentiation beyond efficacy & safety will be important:
• Dosing convenience (i.e. less frequent injections or oral)
• Weight loss kinetics (slope of weight loss)
• Data in sub-populations
Payors have not said much about coverage decisions, which have historically been a challenge in this market, albeit with less effective drugs
With so many eligible patients, payor budgets could be stretched in the near-term
We will likely see restrictions & step-throughs
The CDC estimates the annual medical cost of obesity for US adults to be >$170B, excluding indirect costs
$LLY and $NVO have argued AOMs can reduce long-term costs & improve outcomes by preventing downstream metabolic & CV disease
Critical to this argument will be the 2023 trial readouts measuring CV outcomes benefits:
• $NVO SELECT trial
• $LLY SUMMIT trial
~60% of payors polled felt positive readouts would improve coverage meaningfully, although not overnight
Source for catalysts: GS
The reimbursement dynamic here is similar to curative modalities such as cell & gene therapy
With patients switching insurance every few years, paying for preventative care does not mean reaping the benefits of future health
This analysis has been focused on general (polygenic) obesity, but there is a separate pipeline for various genetically-driven obesities (monogenetic obesity)
One player in this space is $RYTM which launched Imcivree for patients with 3 genetic deficiencies (POMC, PCSK1, LEPR)
Overall, this market will be one to watch in 2023 & beyond as a driver of an industry rebound
That's all - if you enjoyed this, follow me @andrewpannu for more biotech charts, musings and breakdowns and consider sharing the below with your audience
Public market performance of AI-enabled drug developers (a subset of the #TechBio space)
How they've performed (and why they've struggled):
Following several high-profile IPOs, shares of AI-enabled drug developers (AIDD) briefly peaked in Q1'21, before underperforming every quarter thereafter
Collective underperformance of this group:
vs. XBI: (~52%)
vs. NBI (~69%)
vs. S&P (~74%)
What happened?
Given the entire subsector has moved downwards in tandem, we can first look at macro factors:
(1) Generalist and retail investors fled the space: if we use the ARK Genomic Revolution ETF as a proxy for retail sentiment, we see a strong correlation with AIDD performance
My view on the top acquirers for $MDGL after yesterday's stellar data announcement in NASH
+ key late-stage pipeline assets in NASH & catalysts through 2023 & beyond:
I pulled together the initial list above based on big pharma exposure to the NASH / metabolic space and then gave each a score based on these criteria:
(1) Current NASH pipeline (2) Past BD and M&A activity in NASH (3) Mgmt. commentary on M&A preferences (4) Gut feeling
More context on (1): given the emerging belief that combining multiple MoAs is the best way to address the complex pathophysiology of NASH, resmetirom could become a critical combo agent, and thus even companies with their own late-stage pipelines would be interested
I pulled together 44 companies with a range of approaches & segmented assets by development phase
Let's take a deeper look
Keep in mind, this is not the entire cell therapy landscape, but a good snapshot of clinical progress & key assets
With 6 approved products, >$5B in aggregate sales & a shift into earlier treatment lines, cell therapy awareness and adoption has hit a commercial inflection point
Outstanding data and heightened patient awareness have caused demand to outstrip supply, most notably for anti-BCMA CAR-Ts in myeloma
This has amplified the logistical & manufacturing concerns long associated with CAR-T and limited treatment to the specialized hospital setting