TG Therapeutics voluntarily withdraws its UKONIQ approval for applications in marginal zone lymphoma (MZL) and follicular lymphoma (FL) that it had received from US FDA in February 2021. This is based on recent data for Unity Phase 3 trials. Although, the product never accounted for large part of Alembic’s revenues as it was in build up phase, its a little sad as this was the first NDA approval for a drug developed by Indian scientists. The detailed press release is below.
Disclosure: Invested (position size here, bought few shares in last 30 days)
Updates: As I read through the press release, it seems that the initial Phase 3 study had passed the primary endpoint. However, there was a secondary endpoint which wasn’t met initially, company claims that this was because the trials were not designed to collect that data properly. FDA wanted to be sure that the secondary end point was also met and they called a committee to judge the scientific appropriatness of the same while judging a subsequent BLA/sNDA application by TG Therapeutics. For this new application, there was another trial which was organized where the secondary data point was properly collected. As results of the secondary data point was analyzed, company realized that the therapy doesn’t do what its supposed to do. Thus, they withdrew their new application and along with retracting their older approval. Note: I might have oversimplified this explanation, this is what the press release kind of says. Although, I am not a biology/drug expert, so please read the press release for yourself at the link above.
The updated numbers are below. Some of the major highlights for me were:
ANDA filing rate has been maintained. US revenue per launch reduced drastically from 23.5 cr. in FY21 to 15.87 cr. in FY22
Gross margins were at ~73%, with all the pricing pressure they were able to maintain good gross margins
Domestic market is doing very well which is a reflection of change in strategy (MR productivity increased from 30 lakh in FY21 to 35 lakhs in FY22 + 500 new MRs were added).
Alembic Pharma was able to get one new brand in top 300. Domesti market share has increased slightly from 1.4% in FY21 to 1.5% in FY22 (mostly because of very strong growth in azithral which crossed 450 cr. sales in 2021)
Changed 3PL distributor in USA
In domestic markets, company doesn’t focus on new to market launches. The approach is to gain market share gradually in already existing molecules
US growth has been due to increase in market share in some products + few shortages
Indian brands are currently valued very highly, not ready to acquire at these multiples
High R&D is because of accelerated amortization of R&D costs from Aleor
FY16
FY17
FY18
FY19
FY20
FY21
FY22
Cumulative ANDA filed
76.00
96.00
132.00
161.00
183.00
212.00
230.00
Cumulative ANDA approved (tentative excluded)
42.00
46.00
61.00
77.00
107.00
123.00
138.00
Products commercialized
34.00
37.00
44.00
53.00
76.00
92.00
105.00
Products commercialized (own frontend)
86.00
DMF filing
81.00
90.00
94.00
100.00
109.00
117.00
125.00
Consolidated revenue
3’181.20
3’134.00
3’131.00
3’935.00
4’606.00
5’393.00
5’306.00
US revenues (mn $)
130.38
177.56
India
1’103.60
1’254.00
1’274.00
1’382.00
1’425.00
1’497.00
1’926.00
International formulations
1’461.50
1’236.00
1’206.00
1’782.00
2’473.00
2’942.00
2’441.00
International generics
International branded
US
1’227.66
919.00
920.00
1’288.00
1’976.00
2’163.00
1’666.00
Non-US
233.84
317.00
286.00
494.00
497.00
779.00
775.00
Export incentives
APIs
524.90
643.00
651.00
771.00
708.00
955.00
939.00
R&D expense
10.88%
13.72%
13.09%
12.66%
14.00%
12.42%
15.80%
R&D (cr.)
346.00
430.00
410.00
498.00
645.00
670.00
838.35
CAPEX
320.00
480.00
600.00
626.00
697.00
687.00
467.00
EBITDA margin
31.62%
19.56%
20.50%
22.24%
26.34%
30.24%
18.00%
PAT margin
22.61%
12.73%
13.06%
14.84%
18.00%
21.84%
10.29%
Debt
ROCE (excluding new projects)
53.00%
27.00%
25.00%
30.00%
32.00%
41.00%
19.00%
Indian MR count
5’000.00
5’000.00
5’000.00
5’000.00
5’000.00
5’000.00
5’500.00
India acute share
37.00%
33.00%
34.00%
33.00%
36.11%
India specialty share
54.00%
58.00%
56.00%
57.00%
52.78%
India vet share
9.00%
9.00%
10.00%
10.00%
11.11%
India market share
1.73%
1.50%
1.57%
1.50%
1.40%
1.50%
India (brands in top 100)
India (brands in top 300)
5.00
5.00
5.00
5.00
3.00
2.00
3.00
India revenue per MR (lakh / year)
22.07
25.08
25.48
27.64
28.50
29.94
35.02
US revenue (mn $) per launch
2.96
3.35
US revenue (cr) per launch
36.11
24.84
20.91
24.30
26.00
23.51
15.87
US revenue (cr) per accepted
29.23
19.98
15.08
16.73
18.47
17.59
12.07
Disclosure: Invested (position size here, no transactions in last 30-days)
F3 (Karkhadi): General injectables (10 observations pushes back commercialization by few months; filed 15 ANDAs) + Ophthalmic (awaiting regulatory approval)
Launched 13 products (vs 16 in FY21), filed 23 ANDAs (vs 29 in FY21), got 15 final approvals (vs 16 in FY21), filed 8 DMFs (same in FY21)
Top-5 suppliers in 62 products (vs 47 in FY21)
Witnessed steep pricing pressure in FY22
FY22 is the new base and company will grow by launching new products. Plan to file 25 ANDAs annually and launch 15 products (OSD, injectables, ophthalmic, derma)
Pipeline of 131 ANDAs
Filling rates have stayed at 97-98% in last 3-years leading to high reliability. Refused few customers where back end supply chain was fully occupied
Aleor became wholly owned subsidiary (paid 76 cr. for 40% stake; FY22 sales: 38.9 cr.). Expensed out 188 cr. in intangible assets
Competitive pressure in derma space has increased significantly. Aleor is positioned as a low cost manufacturer
Non-US generic (sales: 775 cr., de-growth @(-1%))
149 filings
Have presence in 20+ countries in Europe. Mostly tender driven market
Australia: Few distributors control entire market. Currently have 23 dossiers commercialized or approved
South Africa: Ventured in 2014, have witnessed success recently. Currently have 23 dossiers commercialized or approved
Looking to venture in LATAM, filing aggressively in South-east Asian markets
Domestic business (sales: 1’926 cr., growth @29% vs 18% for industry)
10 therapeutic areas (vs 10 in FY21), 18 (vs 17 in FY21) marketing divisions, 5500+ MRs (vs 5’000 in FY21) catering to 2.22 lakh doctors (vs 1.75 lakh in FY21)
Launched 5 new products
1.51% market share (vs 1.4% in FY21), 3 brands in top-300 (vs 2 in FY21). 9-10 brands generating 50 cr.+ sales
Gained due to COVID and black fungus (azithral, amphotericin)
21.5% (vs 19% in FY21) product in NLEM, 64% (vs 69% in FY21) of sales came from chronic and 36% (vs 31% in FY21) from acute
Have revamped complete Indian MR team and infused young talent directly from colleges. 66% of field force is under 30
Migrated stockist to lower inventory model which led to higher demand-pull thereby improving MR attrition
Registered strong growth in women healthcare portfolio
API (sales: 939 cr., de-growth @(-2%))
Ex-azithromycin portfolio grew well
Manufactures 100 APIs, 38% captive consumption (vs 33% in FY21)
R&D (15.8% of sales vs 12.4% in FY21)
838 cr. (vs 694 cr. in FY21), 90% of R&D spends are targeted towards US market
Created a dedicated technology transfer team to facilitate seamless DMF/ANDA filing
Three R&D segments – formulations, API and peptides
Company has created a peptide R&D unit a few years back to develop peptide APIs for complex injectables. Company has built 100% in-house capability in doing characterization of peptide-based injectables
Intensified efforts to maximize solvent recovery, reducing consumption of fresh solvent in manufacturing process. Residue generated in the solvent recovery process, which used to be incinerated earlier, is now sent to cement factories in vicinity
1200+ R&D employee strength (same as last year)
Facilities in Vadodara, Hyderabad and New Jersey
o Vadodara unit is the mainstay innovation center developing non-oncology molecules
o Hyderabad unit develops oncology and non-oncology molecules
o US unit is focused on developing and filing oral solids and liquid products. It adds complimentary skill sets in soft gelatin based oral solids and oral liquids
Capex (482 cr. vs 687 cr. in FY21)
Have cumulatively invested 3’000+ cr. over last 5-years
Financials
Revenues de-grew by (-2%) to 5’306 cr., EBITDA margins: 18% (vs 30% in FY21), PAT margins: 10% (vs 22% in FY21), R&D: 15.8% of sales (vs 12% in FY21), ROCE (excluding new projects): 19% (vs 41% in FY21), ROE: 11% (vs 23% in FY21), Debt to equity: 0.12 (vs 0.1 in FY21)
Miscellaneous
Hedge 35-40% of net exposure
Employees: 11’974 (vs 12’160 in FY21)
KMP remuneration (including close members to KMP): 86 cr. (vs 88 cr. in FY21)
Related party purchases from Shreno Publications: 31.96 cr. (vs 26.16 cr. in FY21)
CSR: Spent 22 cr. (vs 17.6 cr. in FY21) (no outstanding obligations)
Shareholders: 108’622 (vs 101’950 in FY21)
Auditor remuneration: 1.51 cr. (vs 1.4 cr. in FY21)
Contingent liability: No major liability except corporate guarantee of 61.35 cr. (vs 96.04 cr. in FY21)
Disclosure: Invested (position size here, bought shares in last-30 days)
APL CWIP is more than “net asset”. Many of the projects have started 3 years back.
3000 Cr CAPEX in last 5 Years, went into:
following theoretic areas/delivery mechanism:
a) Dermatology,
b) Ophthalmology,
c) Oncology
d) Injectable Formulations
which have reasonably less competition
3 facilities are waiting for approval
a) F2 - oral solids - already approved
but, waiting for patent expiry
My interpretation: meaningful revenue 2-3 years away
b) F3 - injectable unit
USFDA observation setback
remediation - 1 year
validation batches - 1-1.5 years
commercialization ramp up - 1-1.5 years
My interpretation: meaningful revenue 3-4 years away
c) F4 - manufacturing oral solid dosages
My interpretation: meaningful revenue 3-4 years away
Current plants in Gujarat (6) are running in full capacity.
AP is turning away new customers.
Above average topline growth (15% or above) seems to be
3 to 5 years away. As these CAPEX are funded from internal
accrual, no worries about interest payment. However, aggressive
depreciation policy, if adopted, might reduce profit in
the next few years.
Another bad set of numbers, revenues de-grew by (5%) and company reported net losses (largely due to Aleor R&D expensing). Ex-of that, margins have been hit and came at around 10% vs 18-20% in last year. Price erosion is mid double digits in US. Concall notes below.
FY23Q1 concall
US generics sales was flat despite gain in market share in existing products + launch of 5 new products. Will launch 5-6 in Q2 and 15-18 products in FY23
US base business is $50-55mn. Next quarter it will be close to $50mn as company is seeing lot more price erosion (low double digits) right now vs what they were seeing at end of Q4
In domestic business, branded business (ex-covid) grew @20%
R&D write-offs in Aleor worth 115 cr. – 100 cr. was booked in other expenses + 15 cr. in depreciation (40 cr. is residual value)
Total Aleor R&D spends were ~350 cr. in last 3-4 years. Alembic itself expenses out its R&D
R&D costs will stay at 650-700 cr. annually
Of the operational expenses in CWIP, 180-200 cr. will be cash expenses and 150 cr. of depreciation (once the plants are operationalized)
Disclosure: Invested (position size here, bought shares in last-30 days)
Sales growth look a bit higher than they actually are due to one-time opportunities in US. The good news is they have finally started getting approvals for injectables. Concall notes below.
FY23Q2 concall
US base business is $45-50m, quarterly revenues were higher at $52mn due to certain one time opportunities
US price erosion was in high teens. In some products, it was as high as 30%
Normalized API business growth is 10%, it was higher this quarter
F2 & F3 plants have 50 filings of which 7-8 are oral solids and rest are injectables
gBrovana: Market share increased to 10% (commercialized through CMO)
Ex of covid (amphotericin-B) sales, Indian business growth was 11% YOY
15% of domestic portfolio is under NLEM
Disclosure: Invested (position size here, no transactions in last-30 days)
