Last close As at 05/08/2026
—
— 0.00 (0.00%)
Market capitalisation
—
Research: Healthcare
The US FDA has approved BYFAVO (remimazolam) for injection, a very rapid onset/offset intravenous benzodiazepine sedative for use during invasive medical procedures in adult patients lasting 30 minutes or less. This is Acacia’s second asset approval this year following the US approval on 26 February of its lead asset, BARHEMSYS (amisulpride injection) for the management of PONV. 2020 is a transformative year for Acacia marking its evolution into an integrated hospital pharmaceutical company with strong development and commercialisation capabilities. BYFAVO broadens Acacia’s US commercial pipeline and will enable significant leverage of its commercial infrastructure in the US on launch. Timely launches and effective sales execution of both products is critical. Our revised valuation is €1.03bn.
Written by
Acacia Pharma |
BYFAVO receives FDA approval |
FDA approval |
Pharma & biotech |
6 July 2020 |
Share price performance
Business description
Next events
Analysts
Acacia Pharma is a research client of Edison Investment Research Limited |
||||||||||||||||||||||||||||||||||||||||||||||||||
The US FDA has approved BYFAVO (remimazolam) for injection, a very rapid onset/offset intravenous benzodiazepine sedative for use during invasive medical procedures in adult patients lasting 30 minutes or less. This is Acacia’s second asset approval this year following the US approval on 26 February of its lead asset, BARHEMSYS (amisulpride injection) for the management of PONV. 2020 is a transformative year for Acacia marking its evolution into an integrated hospital pharmaceutical company with strong development and commercialisation capabilities. BYFAVO broadens Acacia’s US commercial pipeline and will enable significant leverage of its commercial infrastructure in the US on launch. Timely launches and effective sales execution of both products is critical. Our revised valuation is €1.03bn.
Year end |
Revenue ($m) |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/18 |
0.0 |
(21.6) |
(0.45) |
0.00 |
N/A |
N/A |
12/19 |
0.0 |
(23.5) |
(0.37) |
0.00 |
N/A |
N/A |
12/20e |
2.1 |
(34.3) |
(0.50) |
0.00 |
N/A |
N/A |
12/21e |
28.8 |
(40.2) |
(0.58) |
0.00 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
BARHEMSYS and BYFAVO US launches ahead
In January, Acacia in-licensed BYFAVO from Cosmo, in a multi-faceted and complex deal that involves two-way cash transfers. In terms of strategic fit for Acacia, like lead product BARHEMSYS, BYFAVO is a product where detailing is directed to anaesthesia providers. Our forecast for peak BYFAVO sales of $126m is unchanged. We note that BYFAVO may not be marketed in the US until the Drug Enforcement Administration (DEA) has determined its scheduling under the Controlled Substances Act, which is expected to take place within the next few months. Restrictions by the DEA may lead us to revise our peak sales assumptions.
Near-term funding secured
With two de novo product launches expected this year, the near-term focus for Acacia’s management is on expanding its marketing capabilities and obtaining access to US hospital pharmacy formulary lists to support its successful sales execution. Management is closely monitoring timing for the recruitment of key commercial personnel. The approval of BYFAVO triggers access to a €25m loan facility from Cosmo. Acacia Pharma will make a €30m upfront payment to Cosmo for the license of BYFAVO (triggered by the approval), consisting of €15m in cash and €15m in ordinary shares of Acacia Pharma stock. This means Acacia will receive €10m in net cash to help fund the US launch of BYFAVO.
Valuation: €1.03bn or €15.1/share
We increase our valuation to €1.03bn vs €992.1m previously. We apply 100% probability of success to BYFAVO vs the 90% risk adjustment prior to its FDA approval. Our forecasts are unchanged, but we have rolled our model forward.
Acacia Pharma is a research client of Edison Investment Research Limited
Exhibit 1: Financial summary
US$m |
|
|
2018 |
2019 |
2020e |
2021e |
PROFIT & LOSS |
||||||
Revenue |
|
|
0.0 |
0.0 |
2.1 |
28.8 |
Operating revenues |
|
|
0.0 |
0.0 |
2.1 |
28.8 |
Cost of sales |
|
|
0.0 |
0.0 |
(0.2) |
(2.6) |
Gross profit |
|
|
0.0 |
0.0 |
1.9 |
26.2 |
Gross margin % |
|
|
N/A |
N/A |
0.9 |
0.9 |
SG&A (expenses) |
|
|
(15.0) |
(18.5) |
(31.2) |
(54.3) |
R&D costs |
|
|
(5.0) |
(3.9) |
(2.8) |
(10.0) |
Other income/(expense) |
|
|
0.0 |
0.0 |
0.0 |
0.0 |
EBITDA (reported) |
|
|
(20.0) |
(22.4) |
(32.1) |
(38.0) |
Depreciation and amortisation |
|
|
0.0 |
0.0 |
0.0 |
0.0 |
Reported Operating Income |
|
|
(20.0) |
(22.4) |
(32.1) |
(38.0) |
Operating Margin % |
|
|
N/A |
N/A |
N/A |
N/A |
Finance income/(expense) |
|
|
(1.5) |
(1.1) |
(2.3) |
(2.1) |
Exceptionals and adjustments |
|
|
0.0 |
0.0 |
0.0 |
0.0 |
Reported PBT |
|
|
(21.6) |
(23.5) |
(34.3) |
(40.2) |
Income tax expense (includes exceptionals) |
|
|
0.9 |
0.7 |
0.7 |
0.7 |
Reported net income |
|
|
(20.7) |
(22.8) |
(33.7) |
(39.5) |
Basic average number of shares, m |
|
|
44.1 |
53.7 |
67.9 |
67.9 |
Year-end number of shares, m |
|
|
53.3 |
54.9 |
67.9 |
67.9 |
Basic EPS ($) |
|
|
(0.47) |
(0.43) |
(0.50) |
(0.58) |
Adjusted EPS ($) |
|
|
(0.45) |
(0.37) |
(0.50) |
(0.58) |
Dividend per share ($) |
|
|
0.00 |
0.00 |
0.00 |
0.00 |
BALANCE SHEET |
|
|
|
|
|
|
Property, plant and equipment |
|
|
0.0 |
0.0 |
2.1 |
3.2 |
Goodwill |
|
|
0.0 |
0.0 |
0.0 |
0.0 |
Intangible assets |
|
|
0.0 |
0.0 |
0.0 |
0.0 |
Other non-current assets |
|
|
0.0 |
0.4 |
47.4 |
47.4 |
Total non-current assets |
|
|
0.0 |
0.4 |
49.5 |
50.5 |
Cash and equivalents |
|
|
37.4 |
17.0 |
14.7 |
12.5 |
Inventories |
|
|
0.0 |
0.0 |
0.0 |
0.5 |
Trade and other receivables |
|
|
0.4 |
0.6 |
0.3 |
4.7 |
Other current assets |
|
|
0.9 |
0.7 |
0.7 |
0.7 |
Total current assets |
|
|
38.7 |
18.3 |
15.7 |
18.3 |
Non-current loans and borrowings |
|
|
8.9 |
4.7 |
47.5 |
87.5 |
Other non-current liabilities |
|
|
0.0 |
0.0 |
0.0 |
0.0 |
Total non-current liabilities |
|
|
8.9 |
4.7 |
47.5 |
87.5 |
Trade and other payables |
|
|
4.7 |
4.2 |
4.3 |
7.4 |
Current loans and borrowings |
|
|
0.5 |
5.5 |
0.0 |
0.0 |
Other current liabilities |
|
|
0.0 |
0.0 |
0.0 |
0.0 |
Total current liabilities |
|
|
5.2 |
9.6 |
4.3 |
7.4 |
Equity attributable to company |
|
|
24.7 |
4.3 |
13.4 |
(26.1) |
CASH FLOW STATEMENT |
|
|
|
|
|
|
Operating Profit |
|
|
(21.6) |
(23.5) |
(34.3) |
(40.2) |
Depreciation and amortisation |
|
|
0.0 |
0.0 |
0.0 |
0.0 |
Share based payments |
|
|
0.0 |
0.0 |
0.0 |
0.0 |
Other adjustments |
|
|
1.6 |
1.1 |
2.3 |
2.1 |
Movements in working capital |
|
|
(3.9) |
(0.8) |
0.3 |
(1.6) |
Interest paid/received |
|
|
0.2 |
0.4 |
(2.3) |
(2.1) |
Income taxes paid |
|
|
0.4 |
0.8 |
0.7 |
0.7 |
Cash from operations (CFO) |
|
|
(15.4) |
(19.8) |
(33.6) |
(41.1) |
Capex |
|
|
0.0 |
0.0 |
(2.2) |
(1.4) |
Acquisitions & disposals net |
|
|
0.0 |
0.0 |
0.0 |
0.0 |
Other investing activities |
|
|
0.2 |
0.4 |
0.4 |
0.3 |
Cash used in investing activities (CFIA) |
|
|
0.2 |
0.4 |
(14.6) |
(1.1) |
Net proceeds from issue of shares |
|
|
47.1 |
0.2 |
8.5 |
0.0 |
Movements in debt |
|
|
1.8 |
(1.0) |
37.4 |
40.0 |
Other financing activities |
|
|
0.0 |
(0.1) |
0.0 |
0.0 |
Cash from financing activities (CFF) |
|
|
48.9 |
(0.9) |
45.9 |
40.0 |
Cash and equivalents at beginning of period |
|
|
4.1 |
37.4 |
17.0 |
14.7 |
Increase/(decrease) in cash and equivalents |
|
|
33.3 |
(20.4) |
(2.3) |
(2.2) |
Cash and equivalents at end of period |
|
|
37.4 |
17.0 |
14.7 |
12.5 |
Net (debt)/cash |
|
|
28.1 |
6.9 |
(32.9) |
(75.1) |
Source: Acacia Pharma, Edison Investment Research
|
||||||||||||
|
||||||||||||
Research: Consumer
Bragg’s Q120 results demonstrated strong revenue growth (44% y-o-y), adjusted EBITDA margin expansion (to 8.7%) and improved free cash flow generation. Operationally, it continues to win new customers in new geographies and enhance product functionality, which should continue to improve the customer offer, drive growth and de-risk the business. Management has reiterated FY20 guidance for revenue and EBITDA growth of at least c 32% and 349%, respectively, vs FY19. The key drivers of share price performance will be continued strong operating performance and financing the Oryx deferred consideration, part due in September 2020.