Rx and market share trends for key US products: IIFL Capital Services

16 Sep 2022 , 03:45 PM

Key takeaways include
·         Dr. Reddy’s launched generic Revlimid in early September 2022 with 180-day exclusivity in 2.5mg and 20mg strengths. Aizant Drug Research Solutions is Dr. Reddy’s manufacturing partner.
·         Dr. Reddy’s continues to maintain the highest market share (MS) of ~16% among generic players in Vascepa market
·         Lupin’s MS in Albuterol market in Q2FY23 till date remained flat QoQ at 15.8%, while competition from Hikma led to Cipla’s MS in Albuterol declining from 18.4% in Q1 to 16.5% in Q2 till date.
·         In Brovana, Cipla/Teva gained 2.5%/3.6% MS in Q2 so far, while innovator/Slate Run/Lupin lost 3.3%/1.9%/1.5% MS, respectively.
·         Cipla captured ~9% MS within 7 months of launch in complex peptide injectable Lanreotide through its 505(b)(2) product.
·         Sun Pharma’s Ilumya is clocking 8% QoQ/48% YoY growth in monthly IU volumes run-rate in Q2 till date, while Cequa’s monthly IU volumes run-rate is up 7% QoQ/60% YoY in Q2.
·         Winlevi clocked annualized TRx run-rate of 489K in August 2022 — the highest since its launch.
·         Alembic captured 9-10% MS in Perforomist market within 5 months of the launch.
·         Biocon’s MS in Insulin Glargine has ramped-up to ~11% currently versus ~10% in Q1FY23.
 
Revlimid — Teva/Natco’s MS continues to remain in mid-to-high teens; Dr. Reddy’s launched with 180-day exclusivity in 2 strengths

After launching 5/10/15/25mg strengths of Revlimid in March 2022, Natco/Teva have maintained their MS at mid-to-high-teens. Per latest weekly Symphony TRx data ending September 2, Natco/Teva have ~15% MS in Revlimid, which will likely moderate going forward as BMS (innovator) has indicated Teva/Natco’s MS to be in mid-single-digit during the first year of launch due to volume limit per the settlement agreement.

Dr. Reddy’s launched generic Revlimid in early September 2022 with 180-day exclusivity in 2 of the 6 strengths, namely 2.5mg and 20mg, which accounted for 6-7% of Revlimid’s overall TRx volumes prior to generic launch from Natco/Teva. Analysts at IIFL Capital Services expect Dr. Reddy’s to generate ~USD100m/210m revenue from Revlimid in FY23/24 (10%/17% of FY23/24 US revenue). Hyderabad-based Aizant Drug Research Solutions is Dr. Reddy’s manufacturing partner for Revlimid.

In addition to Natco/Teva and Dr. Reddy’s, Lotus, Apotex, Mylan, Cipla and Zydus also have USFDA approval for generic Revlimid. Analysts at IIFL Capital Services expect these players to launch their products in the near term.
 
Albuterol — Lupin’s MS remained flat QoQ in Q2FY23 till date, while Cipla’s MS declined ~2%

Per latest weekly TRx data, Lupin’s MS in overall Albuterol market stood at 15.8% in Q2FY23 quarter till date (versus 15.7% in Q1FY23). Hikma’s MS in overall Albuterol market improved from ~1% in Q1 to ~3% in Q2FY23 till date (up 2.2%), largely at the expense of Cipla (down ~2%) whose MS declined from 18.4% in Q1FY23 to 16.5% in Q2FY23 quarter till date (till September 2).
During Q2FY23 so far, Lupin’s MS in Proair market remained flat sequentially at 30.5%. Hikma’s MS in Proventil improved ~10% from ~4% to ~14% at the expense of Cipla, as Cipla’s MS in the Proventil market declined ~11% from ~86% in Q1FY23 to ~75% in Q2FY23 till date.

Brovana — Cipla, Teva, and Sun (new launch) gained MS at the expense of innovator, Slate Run Pharma and Lupin; TRx volumes for Alembic not reflecting in latest TRx data

During Q2FY23 till date, Cipla/Teva gained 2.5%/3.6% MS versus Q1FY23, while innovator/Slate Run Pharma/Lupin lost 3.3%/1.9%/1.5% MS, respectively. Innovator’s MS in Brovana market has declined by 10% over the last 5 months, from ~23% as of Q4FY22 to ~13% during Q2FY23 till September 2.

Sun Pharma launched generic Brovana in end-July and has captured 2.4% MS in 5^th week of the launch. While Sun and Alembic Pharma had received USFDA approvals in May 2022, analysts at IIFL Capital Services believe Alembic has not yet launched the product as its prescription volumes are not reflecting in latest weekly TRx data. Germany-based CMO Holopack is Alembic’s manufacturing partner for Brovana.

Advair — Analysts at IIFL Capital Services believe Cipla will launch its generic product in this highly competitive market during H2FY23

Per latest weekly TRx data, GSK (innovator) has gained ~1% MS during FY23 till date – largely at the expense of Mylan – it now has ~55% MS in Advair market, while MS for Prasco (AG), Hikma and Teva remained largely flat during FY23 so far. Potential clearance of USFDA’s ‘483 with 2 observations for Indore facility (issued after the PAI) will pave the way for Cipla’s generic Advair launch. Analysts at IIFL Capital Services believe Cipla remains on track to launch the product in H2FY23, in-line with management guidance. They estimate that Cipla will generate USD65m/80m in FY24/25 revenue from Advair (7%/8% of FY24/25 US revenue).

Symbicort — Cipla’s P-3 clinical trials ongoing

While Mylan has received USFDA approval for Breyna (generic Symbicort), it has not yet launched the product supposedly owing to ongoing patent litigation now also involving AstraZeneca’s new patent (11,311,558). Per latest weekly TRx data, AstraZeneca (innovator)/Prasco (AG) have 77%/23% MS in Symbicort, resp. Currently, Cipla’s P-3 clinical trials are ongoing for Symbicort (clinicaltrials); analysts at IIFL Capital Services expect Cipla to launch Symbicort in FY25. They also expect competition from Teva and Vectura (UK-based CDMO developing Symbicort and Spiriva).

Perforomist — Alembic captured 9-10% MS in 5 months; Lupin received USFDA approval in August 2022

Alembic has captured 9-10% MS in Perforomist market within 5 months of the launch. While Mylan has been able to maintain ~46% MS through brand and AG versions, it has lost ~7% MS during FY23 so far, and Teva’s MS has declined ~2.5% during FY23 so far to ~45%. Lupin received USFDA approval in August 2022; analysts at IIFL Capital Services believe Lupin has not yet launched the product as the latest weekly TRx data ending September 2 is not reflecting Lupin’s prescription volumes.

Lanreotide — Cipla captured ~9% MS within 7 months of launch; robust execution in peptide injectables will likely continue

Cipla’s complex peptide injectable Lanreotide [505(b)(2) product] captured ~9% MS in the 7^th month of the launch. As highlighted in IIFL Capital Services’ recent report (Robust execution in complex generics portfolio), unlocking of Cipla’s peptide injectables pipeline has commenced through launch of Lanreotide and other 5 products pending for USFDA approvals. Of these 5 products, analysts at IIFL Capital Services believe 3 could be for generic versions of Vasostrict, Forteo & Saxenda. They believe these products could get launched in the US by FY24/25, with Cipla’s revenue potential being USD30-50m per product.

Vasostrict — Eagle’s MS improved sharply at the expense of innovator, Dr. Reddy’s and American Regent; Aurobindo, Amneal and hastar launched during Q2FY23

Per latest IU volumes, Eagle’s MS improved ~7% to ~32% in Q2FY23 till August 2022) versus ~25% in Q1, while innovator/Dr. Reddy’s/American Regent lost 3.5%/3.5%/1% MS, respectively, over the same period. In Vasostrict, there are already 5 generic players (including AG) and one 505(b)(2) product (by American Regent). Therefore, analysts at IIFL Capital Services believe Vasostrict will likely contribute revenue of only USD20m to Cipla upon launch. Cipla’s patent litigation is pending in district court and 30-month stay expires in September 2024.

Vascepa — Hikma gaining MS at the expense of innovator and Apotex; Dr. Reddy’s MS improved marginally

Hikma’s MS in generic Vascepa increased ~4% to ~14% in Q2FY23 till September 2 from ~10% in Q1FY23, at the expense of innovator/Apotex who lost ~3%/2% MS over the same period. Dr. Reddy’s continues to maintain the highest MS (~16%) among generic players in Vascepa market. While Teva has USFDA approval for generic Vascepa, it has not launched 1gm strength and the same is classified as ‘Discontinued’ in USFDA database. Though Teva has 180-day exclusivity for 500mg strength in Vascepa, the 500mg strength accounts only for ~2% of Vascepa’s overall volumes.

With innovator still having ~62.5% MS in the Vascepa market as of Q2FY23 till date (versus 65% in Q1) and Teva not competing in 1gm strength, generic players have a meaningful headroom for garnering incremental MS in the Vascepa market; analysts at IIFL Capital Services believe Vascepa continues to remain a material opportunity for Dr. Reddy’s.

Suboxone — MS for all players largely stable in Q2FY23 till date with Dr. Reddy’s maintaining its ~19% MS; however, potential launch from Apotex remains a threat

Per latest weekly TRx data, innovator/Alvogen/Dr. Reddy’s/Mylan have ~35%/34%/19%/12% MS as of Q2 till date (largely stable vis-à-vis Q1FY23) in Suboxone market.

Though Dr. Reddy’s MS – after declining ~1.5% during H1CY22 to 19% – has been stable in Q2FY23 till date, there remains a risk of MS loss for all players incl. Dr. Reddy’s from Apotex’ generic launch. Analysts at IIFL Capital Services believe Apotex has not launched the product as prescription volumes are not reflecting in the latest weekly TRx data ending September 2.

Sun Pharma’s Ilumya is clocking strong 8% QoQ/48% YoY growth in monthly IU volumes run-rate

While Ilumya’s average weekly TRx volumes in Q2FY23 till date are up only 1% QoQ, Ilumya’s average monthly IU volumes in July and August 2022 are up 8% QoQ/48% YoY, compared to average monthly IUs in Q1FY23/Q2FY22. Analysts at IIFL Capital Services expect sustained traction for Ilumya to continue owing to its dosing convenience, better compliance with treatment and cost competitiveness. Analysts at IIFL Capital Services expect Ilumya’s global revenue to increase at ~24% CAGR from USD315m in FY22 to USD600m in FY25.

Cequa’s monthly IU volumes run-rate is up 7% QoQ/60% YoY
Cequa’s average monthly IU volumes in July and August 2022 increased 7% QoQ/60% YoY vs. avg. monthly IUs in Q1FY23/Q2FY22. Per latest weekly TRx data, Cequa’s average weekly TRx volumes in Q2FY23 till date are up 3% QoQ. Despite the competition from generic Restasis, Cequa’s MS has in overall dry eye market remained in ~4% range during FY23 till date. Per latest weekly TRx data, generic/AG in Restasis, viz. Apotex/Mylan/KVK/Lupin, have captured 22% MS in overall Restasis and 15% MS in the overall dry eye ophthalmic market.

Despite the generic competition in Restasis, Sun’s Cequa market share has continued to ramp-up; however, risk of price erosion continues to linger over the dry eye ophthalmic market. Hence analysts at IIFL Capital Services expect Cequa’s growth to be lower than Ilumya. They expect Cequa to grow at ~19% CAGR (versus 24% for Ilumya) from USD54m in FY22 to USD90m in FY25.

Winlevi clocked annualized TRx run-rate of 489K in August 2022 (the highest since launch)

Per latest monthly TRx data (till August 2022), Winlevi’s average monthly TRx volumes in Q2FY23 till date increased 5% QoQ compared to average monthly TRX volumes in Q1FY23. Annualized monthly TRx volumes for Winlevi in August 2022 at 489K were the highest since its launch and it is meaningfully higher than 100-370K TRx in the 1^st year of launch for other acne products like Aczone, Epiduo Forte, Acanya and Onexton.

Analysts at IIFL Capital Services expect Winlevi’s revenue to ramp-up from USD10m in FY22 to USD70/80m in FY24/25, on the back of its novel mechanism of action (MOA), field force expansion (fresh hiring of field staff and transfer of field force from Absorica), and robust traction from dermatologists (~10,000 out of ~15,000 dermatologists prescribing acne products in the US have prescribed Winlevi so far).

After a sharp decline in Absorica MS during H2FY22, Sun’s MS in FY23 till date has now stabilized at 41%

This has happened through its brand, AG and LD versions. As of August 2022, Upsher-Smith/Mayne and Teva have ~54% and ~5% MS in the overall Absorica market, respectively. Analysts at IIFL Capital Services expect Sun’s revenue from Absorica to decline from USD70m in FY22 to USD30m in FY25 as Sun has lost significant MS in Absorica.

Sun’s old specialty products continue to exhibit declining trends

Average monthly IU volumes for Yonsa/Odomzo/Levulan in Q2FY23 till date declined 1%/5%/12% QoQ and 4%/23%/14% YoY compared to monthly average IU volumes in Q1FY23 and Q2FY22, respectively.

Growth in Sun’s US generics business will be aided by MS ramp-up in generic Brovana, Ambisome and Pentasa

Sun launched generic Brovana in end-July and has been able to capture 2.4% MS in the 5^th week of the launch. In Ambisome, Sun has captured ~18% MS within 6 months of the launch aided by 180-day exclusivity which analysts at IIFL Capital Services believe will expire during September 2022. Sun manufactures Brovana and Ambisome at its Baska facility.

In Pentasa, Sun targets only 500mg strength that accounts for 88-89% of overall volumes, and Sun has captured ~47% MS in the overall Pentasa market within 15 weeks of launch. Given that there are difficulties in assessing bioequivalence for Pentasa and there are no generic players in Pentasa in the US except Sun, analysts at IIFL Capital Services believe Pentasa will remain a limited competition market and Sun’s US generic business will be aided by Pentasa, Brovana and Ambisome.

Biocon’s steady MS ramp-up in Insulin Glargine continues; unbranded Lantus remains a risk for revenue ramp-up

Biocon’s MS in Insulin Glargine has ramped-up to ~11% versus ~10% in Q1FY23 per latest weekly TRx data ending September 2. Given that Sanofi launched unbranded version of Lantus, and also reduced out-of-pocket costs for uninsured patients by ~65% in the US, analysts at IIFL Capital Services believe that going forward, Biocon’s revenue ramp-up could be lower than the ramp-up in volume MS.

Trastuzumab — Though Biocon’s MS is improving during Q2, it is still below H1CY22 levels

Per latest monthly IU data (till August 2022), during Q2FY23 till date, Biocon, Merck and Pfizer gained 1-1.3% MS largely at the expense of Roche (Genentech) and Teva. Biocon’s MS in Trastuzumab during Q2FY23 till date stood at 8.2% versus 6.9% in Q1FY23; however, still marginally below 8.8% MS during H1CY22.

Pegfilgrastim — Biocon’s MS improves in Q2; increasing competitive intensity a key risk

Per latest monthly IU data (till August 2022), Biocon’s MS in Pegfilgrastim at 9.8% in Q2 till date increased from 8.5% in Q1 and 8.3% during H1CY22. Fresenius Kabi recently received USFDA approval for biosimilar Pegfilgrastim which it had in-licensed from Dr. Reddy’s. With this approval, an already competitive market will see incremental competition from a new player, posing risk to revenue ramp-up for existing players.

Bevacizumab and Aspart — ‘483 from USFDA can further delay the launch of Biocon’s biosimilars

USFDA inspected Biocon’s Bangalore and Malaysia plants recently. Biocon disclosed that it was a pre-approval inspection (PAI) for Bevacizumab, rh-Insulin and Insulin Aspart as well as capacity expansion inspection for Trastuzumab. USFDA issued ‘483s with 11 observations for Bangalore and 6 observations for Malaysia. One of the observations pertains to microbial control, and analysts at IIFL Capital Services believe obtaining USFDA clearance for this observation could be difficult for Biocon. While the approvals for Bevacizumab and Insulin Aspart were pending due to USFDA inspection, the ‘483s will further delay the launch of Biocon’s biosimilars. Currently, Amgen and Pfizer have already captured 83% of Bevacizumab market; hence, Bevacizumab is unlikely to be a meaningful opportunity for Biocon upon launch.

Aczone — Innovator and Mylan gaining MS from Torrent and Taro

Per latest monthly IU data (till August 2022), innovator’s MS in Aczone gel improved from 24% in Q1FY23 to 31% in Q2FY23 till date at the expense of Torrent/Mayne Pharma (MS declined to 41% from 50%) and Taro (MS declined to 25% from 26%), while Mylan captured 3% MS within 4 months of the launch.