Last close As at 05/08/2026
NZD4.75
▲ −0.03 (−0.63%)
Market capitalisation
NZD499m
Research: Healthcare
AFT Pharma recently made announcements affecting several of its marketed products. Importantly, the Australian Therapeutic Goods Administration (TGA) has made an interim decision that all products containing codeine (a key competitor to AFT’s Maxigesic) are to be rescheduled to prescription-only as of 1 February 2018. Also, AFT has licensed its cold/flu product Maxiclear to Angelini in 16 European countries. Additionally, due to continued Metoprolol shortages, the New Zealand government pharmaceutical buying agency, PHARMAC, has requested proposals from alternative providers, potentially affecting AFT’s sales of the product.
Written by
AFT Pharmaceuticals |
Updates on several products |
Product update |
Pharma & biotech |
20 January 2017 |
Share price performance
Business description
Next events
Analysts
AFT Pharmaceuticals is a research client of Edison Investment Research Limited |
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AFT Pharma recently made announcements affecting several of its marketed products. Importantly, the Australian Therapeutic Goods Administration (TGA) has made an interim decision that all products containing codeine (a key competitor to AFT’s Maxigesic) are to be rescheduled to prescription-only as of 1 February 2018. Also, AFT has licensed its cold/flu product Maxiclear to Angelini in 16 European countries. Additionally, due to continued Metoprolol shortages, the New Zealand government pharmaceutical buying agency, PHARMAC, has requested proposals from alternative providers, potentially affecting AFT’s sales of the product.
Year end |
Revenue (NZ$m) |
PBT* |
EPS* |
DPS |
P/E |
Yield |
03/15 |
56.2 |
(11.4) |
(9.46) |
0.0 |
N/A |
N/A |
03/16 |
64.0 |
(10.8) |
(0.11) |
0.0 |
N/A |
N/A |
03/17e |
70.4 |
(14.3) |
(0.15) |
0.0 |
N/A |
N/A |
03/18e |
99.1 |
0.3 |
0.00 |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
Codeine to require a prescription in Australia
With the TGA decision, all codeine-containing products, which are mostly combination painkillers and cough medicines, will require a prescription and will no longer be available over the counter (OTC) after 1 February 2018. With a key OTC competitor now re-scheduled, Maxigesic may increase its market share (currently <1%) in the Australian market for OTC ibuprofen and paracetamol/acetaminophen containing products, which is estimated by IMS Health to be ~NZ$400m.
Maxiclear licensed in 16 European countries
AFT has licensed the combination cold/flu product Maxiclear (500mg paracetamol/acetaminophen and 5mg phenylephrine hydrochloride) to Angelini in 16 mostly southern and eastern European countries for undisclosed upfronts, milestones and royalties. The total addressable market in estimated to be approximately NZ$420m in the licensed areas by IMS Health.
Further Metoprolol downside possible
Due to an ongoing global shortage of Metoprolol, PHARMAC has requested proposals for either a dual listing or sole supply of the beta blocker. As AFT is currently the sole provider of Metoprolol, it is possible it may lose the entire contract for the product, which accounts for ~4% of sales. Timing of a PHARMAC decision is unclear but proposals are due by 27 January 2017.
Valuation: NZ$461m or NZ$4.76 per share
We are maintaining our valuation of NZ$461m or NZ$4.76 per share as we await further clarity on the financial impact of the recent announcements. We expect to update our valuation following clinical results from the NasoSURF and Maxigesic IV clinical studies.
Product updates
AFT has recently announced updates that affect several products, most notably Maxigesic, Maxiclear and Metoprolol. With regards to Maxigesic, the TGA has confirmed an interim decision that all products containing codeine will require a prescription from 1 February 2018. These products were up-scheduled due to the risk of dependence and adverse events associated with their use. In total, market research conducted by the company suggests that 40-47% of current consumers who buy 750 million OTC codeine analgesics each year in Australia would switch to another OTC analgesic rather than get a doctor’s prescription. Maxigesic currently has less than 1% of the Australian market for OTC ibuprofen and paracetamol/acetaminophen containing products, which is estimated by IMS Health to be ~NZ$400m, and with this decision could start increasing its share. Maxigesic reaching the 6.5% market share in Australia, which it has attained in the New Zealand market, would equate to NZ$26m in sales for the product compared to less than 1% currently.
AFT has also announced that it has been able to develop a new Maxigesic oral formulation, which would enable greater clinical benefits and improve the intellectual property position. It is also working on a formulation that can be taken without water, which would be suitable for countries where clean water is not readily available. The IV version is on track with a pivotal Phase III underway in the United States.
Maxiclear licensed by Angelini in Europe
AFT has licensed the combination cold/flu product Maxiclear (500mg paracetamol/acetaminophen and 5mg phenylephrine hydrochloride) to Angelini in 16 mostly southern and eastern European countries (Italy, Spain, Portugal, Russia, Turkey, Czech Republic, Slovakia, Romania, Poland, Hungary, Austria, San Marino, Vatican City, Greece, Bulgaria and Croatia). The total addressable market is estimated by IMS Health to be approximately NZ$420m in the licensed areas. Angelini is a private Italy-based healthcare company with over €1.5bn in annual sales and is currently partnered with AFT on Maxigesic in Italy, Turkey, San Marino and Vatican City. Per the agreement, AFT will receive undisclosed upfront, commercial and regulatory milestones and royalties.
Metoprolol at risk
Metoprolol is a beta blocker used to treat angina, high blood pressure and heart failure. Since November 2015, there has been an ongoing global shortage of the active ingredient, metoprolol succinate, due to a manufacturing issue. In an effort to alleviate the shortage, PHARMAC has requested proposals for either a dual or sole supplier of the product. AFT is currently the sole supplier and will be submitting a proposal to PHARMAC but clearly its contract is at risk. The company announced at its H1 FY17 results that Metoprolol issues hurt sales by NZ$0.6m and estimates it currently accounts for 4% of sales (putting the total at risk between NZ$2m and NZ$3m). Proposals are due by 27 January 2017 but it is unclear when the new supplier would take over. Also, PHARMAC will only consider proposals from companies with existing registrations for metoprolol, which limits the pool of candidates to AFT, AstraZeneca (the originator) and Mylan. On the positive side, AFT announced the company has NZ$7m in PHARMAC tenders outstanding and it recently won hospital prescription contracts totalling A$3.5m per year. So any downside coming from a loss in the Metoprolol contract will likely be replaced by other areas.
NasoSURF and Pascomer
NasoSURF is a proprietary nebuliser for the intranasal delivery of medication with an initial application in conscious sedation, which the company estimates to be a $1.2bn opportunity in the US. An IND is expected this year with pharmacokinetic and efficacy studies likely to be concluded in the next 12-15 months. Licensing discussions are expected to commence around that time as well.
Pascomer (aka Pascaderm in certain markets) is a topical dermatology drug to treat a hereditary skin condition that is being developed as part of a 50/50 joint venture with Medicas Group. The IND is expected in 2017, which will enable a pivotal study to begin. The company estimates potential peak sales for the initial indication to be $600-800m in the US and EU.
Valuation
We are maintaining our valuation of NZ$461m or NZ$4.76 per share as we await further clarity on the financial impact of the recent announcements. We expect to update our valuation following clinical results from the NasoSURF and Maxigesic IV clinical studies.
Exhibit 1: DCF sensitivity table (NZ$)
Terminal EBIT margin |
|||||
Terminal revenue growth |
15% |
25% |
34% |
38% |
42% |
-2% |
2.28 |
3.00 |
3.65 |
3.93 |
4.22 |
-1% |
2.36 |
3.15 |
3.85 |
4.16 |
4.48 |
0% |
2.46 |
3.32 |
4.09 |
4.44 |
4.78 |
1% |
2.57 |
3.53 |
4.39 |
4.78 |
5.16 |
2% |
2.72 |
3.80 |
4.76 |
5.20 |
5.63 |
3% |
2.91 |
4.14 |
5.24 |
5.73 |
6.23 |
4% |
3.16 |
4.59 |
5.88 |
6.45 |
7.03 |
5% |
3.51 |
5.22 |
6.77 |
7.46 |
8.14 |
Source: Edison Investment Research
Financials
We are maintaining our forecasts for the time being. We currently forecast NZ$70.4m in FY17 sales and with a March 2017 fiscal year end do not expect the recent announcements to have much of an impact. We forecast FY18 sales of NZ$99.1m and believe the growth attributable to overseas Maxigesic sales will far outpace any recent issues.
Exhibit 2: Financial summary
NZ$000 |
2014 |
2015 |
2016 |
2017e |
2018e |
2019e |
2020e |
||
March |
NZ GAAP |
NZ GAAP |
NZ GAAP |
NZ GAAP |
NZ GAAP |
NZ GAAP |
NZ GAAP |
||
PROFIT & LOSS |
|||||||||
Revenue |
|
|
48,939 |
56,241 |
64,014 |
70,415 |
99,113 |
126,219 |
151,885 |
Cost of Sales |
(28,609) |
(35,083) |
(40,435) |
(41,926) |
(50,261) |
(58,052) |
(65,367) |
||
Gross Profit |
20,330 |
21,158 |
23,579 |
28,490 |
48,852 |
68,168 |
86,518 |
||
EBITDA |
|
|
(341) |
(9,659) |
(7,821) |
(11,588) |
2,134 |
17,241 |
30,372 |
Operating Profit (before amort. and except.) |
(201) |
(9,530) |
(7,667) |
(11,434) |
2,288 |
17,395 |
30,526 |
||
Intangible Amortisation |
82 |
99 |
114 |
114 |
114 |
114 |
114 |
||
Exceptionals |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Other |
1,594 |
(546) |
(618) |
834 |
2,199 |
2,310 |
2,427 |
||
Operating Profit |
1,475 |
(9,977) |
(8,171) |
(10,487) |
4,601 |
19,820 |
33,067 |
||
Net Interest |
(963) |
(1,908) |
(3,145) |
(2,829) |
(2,000) |
(2,000) |
0 |
||
Profit Before Tax (norm) |
|
|
(1,164) |
(11,438) |
(10,812) |
(14,263) |
288 |
15,395 |
30,526 |
Profit Before Tax (reported) |
|
|
512 |
(11,885) |
(11,316) |
(13,316) |
2,601 |
17,820 |
33,067 |
Tax |
59 |
282 |
42 |
(100) |
(112) |
(4,343) |
(8,579) |
||
Profit After Tax (norm) |
(1,105) |
(11,156) |
(10,770) |
(14,362) |
177 |
11,056 |
21,951 |
||
Profit After Tax (reported) |
571 |
(11,603) |
(11,274) |
(13,416) |
2,488 |
13,477 |
24,488 |
||
Average Number of Shares Outstanding (m) |
1.2 |
1.2 |
96.8 |
96.8 |
96.8 |
96.8 |
96.8 |
||
EPS - normalised (NZ$) |
|
|
(0.94) |
(9.46) |
(0.11) |
(0.15) |
0.00 |
0.11 |
0.23 |
EPS - normalised fully diluted (NZ$) |
|
(0.94) |
(9.46) |
(0.11) |
(0.15) |
0.00 |
0.11 |
0.23 |
|
EPS - (reported) (NZ$) |
|
|
0.48 |
(9.84) |
(0.12) |
(0.14) |
0.03 |
0.14 |
0.25 |
Dividend per share (NZ$) |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
0.00 |
||
Gross Margin (%) |
41.5 |
37.6 |
36.8 |
40.5 |
49.3 |
54.0 |
57.0 |
||
EBITDA Margin (%) |
N/A |
N/A |
N/A |
N/A |
2.2 |
13.7 |
20.0 |
||
Operating Margin (before GW and except.) (%) |
N/A |
N/A |
N/A |
N/A |
2.3 |
13.8 |
20.1 |
||
BALANCE SHEET |
|||||||||
Fixed Assets |
|
|
1,824 |
2,488 |
3,249 |
3,681 |
4,167 |
4,708 |
5,299 |
Intangible Assets |
1,419 |
1,669 |
2,111 |
2,399 |
2,687 |
2,975 |
3,263 |
||
Tangible Assets |
405 |
411 |
407 |
551 |
749 |
1,002 |
1,305 |
||
Investments |
0 |
408 |
731 |
731 |
731 |
731 |
731 |
||
Current Assets |
|
|
23,569 |
30,725 |
62,055 |
46,445 |
48,387 |
61,013 |
72,779 |
Stocks |
12,654 |
14,686 |
17,686 |
18,248 |
21,876 |
25,267 |
28,451 |
||
Debtors |
9,558 |
11,251 |
16,288 |
16,806 |
20,147 |
23,270 |
26,202 |
||
Cash |
1,248 |
4,700 |
28,055 |
11,366 |
6,338 |
12,450 |
18,100 |
||
Other |
109 |
88 |
26 |
26 |
26 |
26 |
26 |
||
Current Liabilities |
|
|
(9,208) |
(10,148) |
(13,511) |
(13,842) |
(15,981) |
(17,981) |
(19,858) |
Creditors |
(9,208) |
(10,148) |
(13,511) |
(13,842) |
(15,981) |
(17,981) |
(19,858) |
||
Short term borrowings |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Long Term Liabilities |
|
|
(13,137) |
(20,739) |
(23,161) |
(23,161) |
(23,161) |
(23,161) |
(11,581) |
Long term borrowings |
(13,137) |
(20,739) |
(23,161) |
(23,161) |
(23,161) |
(23,161) |
(11,581) |
||
Other long term liabilities |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Net Assets |
|
|
3,048 |
2,326 |
28,632 |
13,123 |
13,412 |
24,579 |
46,640 |
CASH FLOW |
|||||||||
Operating Cash Flow |
|
|
614 |
(11,479) |
(11,326) |
(13,060) |
(2,160) |
13,263 |
26,670 |
Net Interest |
(963) |
(1,908) |
(3,145) |
(2,829) |
(2,000) |
(2,000) |
0 |
||
Tax |
59 |
282 |
42 |
(100) |
(112) |
(4,343) |
(8,579) |
||
Capex |
(502) |
(483) |
(694) |
(700) |
(754) |
(808) |
(860) |
||
Acquisitions/disposals |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Financing |
(8) |
12,859 |
38,357 |
0 |
0 |
0 |
0 |
||
Dividends |
0 |
(763) |
(1,652) |
0 |
0 |
0 |
0 |
||
Net Cash Flow |
(800) |
(1,492) |
21,582 |
(16,689) |
(5,027) |
6,112 |
17,231 |
||
Opening net debt/(cash) |
|
|
11,426 |
11,889 |
16,039 |
(4,894) |
11,795 |
16,823 |
10,711 |
HP finance leases initiated |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Other |
337 |
(2,658) |
(649) |
0 |
0 |
0 |
0 |
||
Closing net debt/(cash) |
|
|
11,889 |
16,039 |
(4,894) |
11,795 |
16,823 |
10,711 |
(6,520) |
Source: Edison Investment Research, company reports
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