Sales Snapshot • Q3 Exports so far: $18.27M USD (vs. $40M last Qtr – leaner but promising)
Bempedoic Buzz Returns! • New direct exports of synthetic intermediate (1,15-DIETHYL-2,2,14,14-TETRAMETHYL-8-OXOP) to US’s Corden Pharma for Bempedoic mfg • Bypassing France route – started Sep 11! Fresh agreement? More shipments ahead? • Tariff-proof: Raw chem, skips Trump’s 100% pharma hit
Fresh Wins • 1st-ever Semaglutide injectable samples shipped to US – historic! • Contrast media exports: >2x growth!
Experion announced it reached a settlement agreement with Dr. Reddy’s Laboratories to resolve patent litigation over generic versions of cholesterol medications NEXLETOL and NEXLIZET.
Under the agreement, Dr. Reddy’s Laboratories agreed not to market generic versions of either drug in the United States before April 19, 2040, unless certain limited circumstances occur. The settlement resolves litigation that began after Dr. Reddy’s filed an Abbreviated New Drug Application seeking approval to market generic versions of both medications.
The settlement represents the fourth such agreement Esperion has reached this year regarding generic versions of NEXLETOL. The company previously settled with Micro Labs USA, Hetero USA and Accord Healthcare.
Bempedoic acid, the active ingredient in NEXLETOL, is protected by Esperion’s U.S. Patent No. 7,335,799, scheduled to expire in December 2030. With the Dr. Reddy’s settlement, no remaining challenges exist regarding the validity or infringement of this patent in pending litigation.
Patent litigation continues against five other companies: Alkem Laboratories, Aurobindo Pharma Limited, MSN Pharmaceuticals, Renata Limited and Sandoz. Esperion stated there is no assurance whether the ongoing litigation will prevent generic versions from entering the market before April 19, 2040.
Some of Esperion’s patents subject to the continuing litigation expire in March 2036, while others are scheduled to expire in June 2040.
Blue Jet supplies bempedoic intermediates to/for Esperion → Esperion partners with Otsuka in Japan → therefore Blue Jet might indirectly feed Otsuka. That’s a reasonable hypothesis, but it is not documented publicly.
Regarding recent 60% discount on Repatha, asked Perplexity about impact on Nexletol revenue. See below :
A large discount on Repatha, one of the leading PCSK9 inhibitors, is likely to negatively impact Nexletol’s revenue by intensifying market competition and reducing the price advantage that Nexletol currently enjoys as an oral option. Many payers and providers may preferentially shift to Repatha, especially if the cost difference narrows or disappears, reducing Nexletol’s market share and putting downward pressure on both prescription volume and net sales.
Competitive Dynamics
Repatha is a leading injectable cholesterol-lowering drug with proven efficacy, generating over $2 billion in annual sales and recently offered at a 60% direct-to-consumer discount in the US.
Nexletol, while oral and more convenient, historically benefited from being a more affordable non-statin alternative for patients intolerant to statins and high-priced injectables.
Past price cuts on PCSK9 inhibitors, including Repatha, have already prompted payer resistance to higher-priced therapies, affecting Nexletol’s adoption and diminishing its pricing leverage.
Impact on Nexletol Revenue
Esperion (Nexletol’s manufacturer) has faced anemic sales growth even after positive clinical data, partly due to intense competition from injectables like Repatha and payer preference for lower-cost alternatives.
If Repatha becomes significantly cheaper, payers may respond by preferring it over Nexletol for eligible patients, putting further pressure on Nexletol’s prescription volume.
Nexletol’s forecasted peak sales were based on the assumption that many patients cannot tolerate statins or injections; a discounted Repatha potentially narrows Nexletol’s addressable population, especially if new insurance or payer mandates favor the less costly injectable.
Strategic Considerations
Nexletol remains a preferred option for patients unable or unwilling to use injectables or statins, which insulates part of its market from the impact of Repatha’s discount.
Esperion has expanded indications and is pushing for broader adoption, but further price competition may require Nexletol to either lower prices or enhance value through additional outcomes data and patient support.
Ongoing expansions into new geographies and populations (primary prevention, ex-U.S. launches) may offset some domestic revenue loss.
Summary Table
Product
2022 Sales
Main Route
List Price Trend
Recent Developments
Market Impact on Nexletol
Repatha
$2.2B
Injectable
Discounted 60%
DTC sales, $239/mo cash, broad insurance
Revenue likely down
Nexletol
$56M
Oral
Usually lower
New indications, targeting non-statin users
Pressure to cut price
Nexletol’s revenue will likely decline following deep discounts for Repatha, unless Esperion finds new ways to differentiate, reduce costs, or expand into less direct competition segments. The overall risk is substantial, but mitigated somewhat by population differences in statin and injectable tolerance.
I love how market everytime fails to understand the lumpy nature of CDMO business. Neuland faced the same a few quarters back and within few months now nearing all time high.
Based on the concall, one of the major reasons attributed by the management is due to longer transit time (geopolitical issues) and numbers will reflect in Q3. Only 55% of their produced goods were shown under revenue in Q2. They expect this to normalise in subsequent quarters.
One thing stood out - 3 molecules they are working on which will go into commercial production from FY27 onwards are all blockbusters individually i.e. 1bn +
However, the overall tone of the management felt really low and no clear answers on variation of gross margins.
Few things which i think were important from concall
Initial scale-up of Cardio Blockbuster molecule from initial few Qtrs of almost 100% was mostly for launch volumes which seems to be stabilised now, Additional Volume will be seen in new combination too
They have managed to get some very Big pharma innovator as client
Peptides they spoke about multi Billion dollars opportunity size, needs to see what they capture
To myself, they may see steady compounding growth in FY26/27 with a probability of much better results from FY28 onwards once Vizag facility scale-up starts after Phase 1 capex for same
Generic Settlement: Reached settlements with four generic filers, including Dr. Reddy’s Laboratories, securing market exclusivity for bempedoic acid until 2040.
US Commercial Performance & Access
Strong Coverage: Achieved greater than 90% commercial life coverage and more than 80% Medicare coverage for NEXLETOL and NEXLIZET, with all national commercial and Medicare payers covering all indications.
Prescription Growth: Total retail prescription equivalents increased by approximately 9% and the number of prescribing healthcare practitioners grew to over 30,000.
Global Guidelines & Development
ESC/EAS Inclusion: Bempedoic acid received a Class I, Level A recommendation in the 2025 ESC/EAS guidelines, supporting expanded use across the European Union.
New Drug Development: DSE announced the development of oral triple combination lipid-lowering tablets with simulations showing improved LDL-C goal attainment aligned with the 2025 ESC/EAS guidelines.
International Milestones
Japan Approval: Partner Otsuka received approval for NEXLETOL for hypercholesterolemia in September 2025
Europe Launch: NILEMDO was launched in Denmark, Sweden, and Finland.
Canada Filing: Partner HLS Therapeutics filed New Drug Submissions and expects market approval by year-end 2025.
Upcoming Approvals: Regulatory approval expected in Israel in the first half of 2026 and a marketing application filed in Australia/New Zealand with approval expected in Q4 2026.
Clinical Data & Economic Value
Gout Risk Analysis: Post-hoc analysis of CLEAR Outcomes indicated gout incidence with bempedoic acid was comparable to placebo in patients without a history of gout and normal baseline uric acid. The risk in patients with elevated uric acid may be mitigated with clinically indicated monitoring and use of uric acid-lowering medications.
Favorable Economics (ICER): An economic model demonstrated that bempedoic acid treatment provides a substantial net benefit over standard of care, resulting in:
The ICER for bempedoic acid was well below the US threshold (<$150,000 per QALY), and the fixed-dose combination had a very favorable ICER (<$50,000 per QALY).
Tomorrow Neuland results and concall are scheduled… Innovator has diversified their CDMO base for blockbuster molecule and most probably it has gone to Neuland…
Listening to concall, management seems perplexed with drop in revenues in context of high promises they have made earlier
A very surprising statement (shocking, in fact) in the Blue Jet concall – they don’t know segment wise profitability! It is one thing to say we don’t share, but are they saying they don’t even know?
Even if the production facilities are fungible across segments, each machine would be getting used for only one thing at a time. So, it should be possible to allocate costs accordingly. The management needs to know, simply saying we don’t know how the segments are doing doesn’t look good.
Yes, they are not required by SEBI to disclose segment wise gross margins in their earnings calls or filings unless those segments are reportable under Ind AS 108 (Operating Segments).
I guess which is why such statement has been presented in concall.
Sales Snapshot • Q3 Exports so far: $18.27M USD (vs. $40M last Qtr – leaner but promising)
Bempedoic Buzz Returns! • New direct exports of synthetic intermediate (1,15-DIETHYL-2,2,14,14-TETRAMETHYL-8-OXOP) to US’s Corden Pharma for Bempedoic mfg • Bypassing France route – started Sep 11! Fresh agreement? More shipments ahead? • Tariff-proof: Raw chem, skips Trump’s 100% pharma hit
Fresh Wins • 1st-ever Semaglutide injectable samples shipped to US – historic! • Contrast media exports: >2x growth!
Cost Edge • Low raw imports = slimmer costs, juicier margins incoming
Upcoming: Bempedoic to Japan’s Otsuka Pharma – anytime now!
