Allium has announced FDA approval of its subsidiary Gardia’s Wirion, which has become the only embolic protection system approved for all atherectomy procedures. Allium has reported FY17 results, with revenues up 5% y-o-y to NIS7.7m, and announced its first order in Mexico for NIS300k and approval of some of its stents in Russia. However, registration of the remaining stents and IBI Medical (EndoFast soft tissue fixation) in Mexico and Russia and stents in China has been delayed; we believe approval is possible in 2018. Mexico, Russia and China are the bulk of the distribution deals (NIS132m) and delays are the major reason for the slight decline in our valuation to NIS1.64/share (NIS1.68/share previously).
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Allium Medical Solutions |
Wirion approved by FDA; new stents in Europe |
FY17 results; business update |
Medical devices |
26 April 2018 |
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Allium has announced FDA approval of its subsidiary Gardia’s Wirion, which has become the only embolic protection system approved for all atherectomy procedures. Allium has reported FY17 results, with revenues up 5% y-o-y to NIS7.7m, and announced its first order in Mexico for NIS300k and approval of some of its stents in Russia. However, registration of the remaining stents and IBI Medical (EndoFast soft tissue fixation) in Mexico and Russia and stents in China has been delayed; we believe approval is possible in 2018. Mexico, Russia and China are the bulk of the distribution deals (NIS132m) and delays are the major reason for the slight decline in our valuation to NIS1.64/share (NIS1.68/share previously).
Year |
Revenue (NISm) |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/16 |
7.4 |
(22.0) |
(0.49) |
0.0 |
N/A |
N/A |
12/17 |
7.7 |
(21.4) |
(0.37) |
0.0 |
N/A |
N/A |
12/18e |
14.0 |
(13.7) |
(0.19) |
0.0 |
N/A |
N/A |
12/19e |
21.0 |
(9.6) |
(0.13) |
0.0 |
N/A |
N/A |
Note: *Normalised, excluding amortisation of acquired intangibles and exceptionals.
FDA approves Wirion; chances of transaction higher
Gardia Medical’s Wirion system has received FDA approval for leg artery catheterisation on the back of strong clinical data from the WISE-LE trial, which met its primary and secondary endpoints at interim analysis. Wirion captured a significant amount of debris in all clinical cases and across all atherectomy devices and is now the only embolic protection system cleared by the FDA for all atherectomy procedures. Allium is looking for a strategic transaction, preferably M&A; we believe the FDA approval could make Gardia more attractive to potential partners. We model Wirion as part of Allium’s overall business and valuation and project revenue of NIS2.4m after full launch in 2018, rising to NIS8.6m in 2020 as we adjust our price forecast based on the most recent FY17 data.
Mexico, Russia and China: Approvals and delays
Allium has received the first order for its urological stent products in Mexico for NIS300k, which was paid upfront in Q417. We now expect EndoFast (soft tissue fixation) and the remaining stents to be approved in Mexico and Russia during H118 vs YE17 before. Allium has also received approval in Russia for its stent products and EndoFast could be approved in 2018, as it could in China after it sent a full package to the Chinese FDA in Q417. We reduce our revenue forecast to c NIS14m in FY18 (from NIS16.6m) to reflect these delays, partially offset by a new deal worth NIS6.3m signed in 15 countries in Central and Eastern Europe.
Launch of new stents; Allevetix starts clinical trial
Allium has launched two new CE-marked products in Europe: the Triangular Prostate Stent (TPS) Plus which is a new approach to treat benign prostate hyperplasia; and Ureteral Stent (URS) 200, which self-expands to 200mm length and 9mm diameter. Allium has started a clinical trial with the Allevetix indwelling gastroduodenal sleeve in 10 patients with obesity and diabetes for three months; Allium expects to complete the study by the YE and start a pivotal trial in 2019.
Valuation: DCF of c NIS117m or NIS1.64/share
Our DCF valuation of Allium is NIS1.64/share (vs NIS1.68/share) as a result of updating the launch delays in Mexico, Russia and China and net cash.
FY17 results overview and valuation update
Allium reported sales of NIS7.7m in FY17, up 5% vs NIS7.4m in FY16, but lower than our forecast of NIS9.7m. Allium has received the first order for its ureteral stent products in Mexico for NIS300k, fully paid in Q417. We now expect EndoFast (soft tissue fixation) and the remaining stents to be approved in Mexico and Russia during 2018 vs YE17 previously. The distribution deals are worth a total of NIS74m over five years. Separately, Allium has received approval in Russia for its stent products. Next is approval of EndoFast, potentially in 2018 (deal is NIS48m over five years). Approval in China could be possible in 2018; the company sent a full package to the CFDA in Q417 (deal is NIS58m over eight years). Additionally, Allium has been strengthening the distribution network and has replaced the distributor of stents in the Czech Republic and Slovakia and EndoFast with a new deal in 15 Central and Eastern European countries. The deal involves a minimum purchase of NIS6.3m over five years. Therefore, we reduce our near-term revenue forecast to reflect these delays, partially offset by the new commercial agreement to c NIS14m in FY18 (from NIS16.6m) and c NIS21m in FY19 (from NIS24.9m).
We expect R&D expenses to decrease in 2018 (NIS10m in FY18 vs NIS5m previously) due to public grants from the Israeli government. R&D expenses in 2018 are mainly associated with the continued clinical development of Allevetix and the preclinical study with TruLeaf. From 2019 onwards we expect a decrease in R&D expenses as the company completes clinical development of Allevetix. General and administrative expenses were NIS8.5m in FY17 vs NIS8.1m in FY16. This is above our estimate of NIS7.3m and is mainly related to non-cash, stock-based compensation.
EBITDA loss in FY17 was NIS20.8m vs NIS20.4m in FY16. This is slightly higher than our FY17 estimate of NIS19.5m. We forecast an EBITDA loss of NIS13.2m in FY18, from a loss of NIS6.8m previously. Net loss was NIS22.7m vs our forecast of a NIS21.9m loss. We now forecast a net loss of NIS15.2m in FY18 (vs NIS8.8m before). As a consequence of our revised forecast, we now expect Allium to reach EBITDA break-even in 2020, one year later than before.
Exhibit 1: Key changes to our financial forecasts
NIS000s |
FY16 |
FY17 |
FY18e |
||||
Act. |
Est. |
Act. |
Change (%) |
Old |
New |
Change (%) |
|
Revenue |
7,353 |
9,735 |
7,703 |
-21% |
16,612 |
13,972 |
-16% |
R&D expenses |
(13,494) |
(14,000) |
(13,914) |
-1% |
(5,000) |
(10,000) |
100% |
S&M expenses |
(2,895) |
(2,531) |
(2,458) |
-3% |
(3,322) |
(3,493) |
5% |
G&A expenses |
(8,129) |
(7,250) |
(8,527) |
18% |
(7,000) |
(7,000) |
0% |
Operating profit/loss |
(22,633) |
(21,548) |
(22,842) |
6% |
(8,624) |
(15,100) |
75% |
Profit/loss before tax |
(23,917) |
(21,909) |
(22,679) |
4% |
(8,770) |
(15,236) |
74% |
Profit/loss after tax |
(23,917) |
(21,909) |
(22,679) |
4% |
(8,770) |
(15,236) |
74% |
EPS (NIS) |
(0.53) |
(0.38) |
(0.39) |
3% |
(0.12) |
(0.21) |
75% |
Source: Allium Medical accounts, Edison Investment Research.
During 2017 Allium consumed NIS18.9m in cash vs NIS17.5m in FY16. This is lower than our FY17 estimate of NIS20.1m. Over the year, Allium raised total net proceeds of NIS19.1m. We estimate that net cash, cash equivalents and short-term deposits of c NIS23m provide runway until 2019 when we project a cash shortfall that for illustrative purposes we cover with long-term debt of NIS20m. Cash will be spent on the first-in-man study with Allevetix’s gastroduodenal sleeve (recently started) and the ongoing animal study with TruLeaf.
Research: Investment Companies
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