Vernalis
Written by
Vernalis |
Advancing towards a commercial portfolio |
CCP-008 NDA acceptance |
Pharma & biotech |
5 January 2017 |
Share price performance
Business description
Next events
Analysts
Vernalis is a research client of Edison Investment Research Limited |
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FDA acceptance of the CCP-08 NDA (setting a 4 August 2017 PDUFA date) advances Vernalis towards its goal of building a speciality US franchise of extended release (ER) prescription-only (Rx) cough cold products. Potential 2017 approval of CCP-08 and CCP-07 (PDUFA date 20 April 2017) would enable launch into the 2017/18 cough cold season. Last reported cash of £78.6m (unaudited at end October) supports ongoing investment in operational initiatives to enhance Tuzistra XR sales growth this season and beyond. Successful execution will lay important foundations for the launches of CCP-07 and CCP-08.
Year end |
Revenue (£m) |
PBT* |
EPS* |
DPS |
P/E |
Yield |
06/15** |
19.9 |
(6.9) |
(1.0) |
0.0 |
N/A |
N/A |
06/16 |
12.0 |
(16.2) |
(3.4) |
0.0 |
N/A |
N/A |
06/17e |
12.9 |
(37.6) |
(6.8) |
0.0 |
N/A |
N/A |
06/18e |
40.7 |
(18.4) |
(3.0) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding intangible amortisation, exceptional items and share-based payments. **18-month reporting period, 12 months thereafter.
Third cough cold programme under FDA review
CCP-08 is the third of Vernalis’s cough cold products to be accepted for NDA review; this triggers a milestone payment from Vernalis to partner Tris (we assume $3m). Potential CCP-07 and CCP-08 launches into the 2017/18 cough cold season will leverage the existing Tuzistra XR salesforce and coupled to higher revenue will drive Vernalis to profitability in FY19 on our forecasts. Two other pipeline assets (CCP-05 and CCP-06) are on track for achieving proof of concept in FY17.
Progress in line with management expectations
Over Q416 Vernalis made progress with all operational priorities including improving: (1) patient access (unrestricted insurance coverage of Tuzistra XR is now c 75% of US commercial lives up from c 60%); (2) physician/brand awareness (samples shipped from October); (3) pharmacy stocking (ongoing discussions with numerous national and regional chains); and (4) territory alignment (following the 25% salesforce expansion). These activities have accelerated Tuzistra XR Rx growth, particularly over December, into a cough cold season that, like 2015/16, has started mildly (according to CDC surveillance data). Ongoing investment will underpin future sales growth, but decrease Tuzistra Rx’s net price ($/Rx) for FY17.
Valuation: DCF valuation of £377m (72p per share)
CCP-08 NDA acceptance prompts us to raise its probability of success to 90% from 75%, increasing the rNPV of CCP-08 by £11.8m (13.4p/share) to £70.7m. However, this uplift is largely offset by a lower last reported cash position (£78.6m [unaudited] at end-October vs £84m at end-June reflecting cash burn) resulting in a modestly higher company valuation of £377m or 72p/share (previously £371m or 71p/share). Our valuation consists of US cough cold and NCE pipeline rNPV, explicit cost modelling and inclusion of cash; we assume zero NPV for the research business. Upside would come from portfolio progress, launches and sales upgrades.
Exhibit 1: Financial summary
£000s |
2013 |
2015 |
2016 |
2017e |
2018e |
|||
Year end 30 June (from 2015) previously December |
IFRS |
IFRS |
IFRS |
IFRS |
IFRS |
|||
PROFIT & LOSS |
||||||||
Revenue |
|
|
14,084 |
19,882 |
12,034 |
12,912 |
40,724 |
|
of which: Cough/cold portfolio & Moxatag |
0 |
0 |
1,100 |
4,112 |
31,035 |
|||
Frova royalties |
6,684 |
6,648 |
2,894 |
2,500 |
1,389 |
|||
Collaborative income (R&D funding and milestones) |
7,150 |
13,022 |
8,035 |
6,000 |
8,000 |
|||
Other |
250 |
212 |
5 |
300 |
300 |
|||
Cost of Sales |
(2,244) |
(1,373) |
(2,004) |
(2,492) |
(11,215) |
|||
Gross Profit |
11,840 |
18,509 |
10,030 |
10,420 |
29,509 |
|||
Sales, General & Admin |
(3,299) |
(8,635) |
(25,717) |
(38,673) |
(38,943) |
|||
Research & Development |
(14,416) |
(22,563) |
(10,932) |
(10,995) |
(11,105) |
|||
Other |
180 |
611 |
396 |
0 |
0 |
|||
Operating Profit reported |
|
|
(5,695) |
(11,835) |
(23,572) |
(39,249) |
(20,539) |
|
Intangible Amortisation |
(1,349) |
(571) |
(713) |
(1,009) |
(1,765) |
|||
Exceptionals |
1,608 |
243 |
2,651 |
0 |
0 |
|||
Share-based payment |
(876) |
(1,855) |
(984) |
(247) |
(247) |
|||
EBITDA |
|
|
(4,652) |
(8,855) |
(23,919) |
(37,692) |
(18,233) |
|
Operating Profit (norm) |
|
|
(5,078) |
(9,652) |
(24,526) |
(37,994) |
(18,527) |
|
Net Interest |
420 |
2,733 |
8,315 |
420 |
175 |
|||
Other financial income |
(999) |
(157) |
(42) |
0 |
0 |
|||
Profit Before Tax (norm) |
|
|
(4,658) |
(6,919) |
(16,211) |
(37,573) |
(18,351) |
|
Profit Before Tax (as reported) |
|
|
(6,274) |
(9,259) |
(15,299) |
(38,829) |
(20,363) |
|
Tax |
2,273 |
2,858 |
804 |
2,013 |
2,654 |
|||
Profit from discontinued operations |
0 |
0 |
0 |
0 |
0 |
|||
Profit After Tax (norm) |
(2,385) |
(4,061) |
(15,407) |
(35,561) |
(15,698) |
|||
Profit After Tax (as reported) |
(4,001) |
(6,401) |
(14,495) |
(36,816) |
(17,710) |
|||
Average Number of Shares Outstanding (m) |
442.1 |
442.3 |
449.9 |
526.4 |
526.4 |
|||
EPS - normalised (p) |
|
|
(0.8) |
(1.0) |
(3.4) |
(6.8) |
(3.0) |
|
Dividend (p) |
|
|
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
|
Gross Margin (%) |
84.1% |
93.1% |
83.3% |
80.7% |
72.5% |
|||
EBITDA Margin (%) |
-33.0% |
-44.5% |
-198.8% |
-291.9% |
-44.8% |
|||
Operating Margin (before GW and except.) (%) |
-36.1% |
-48.5% |
-203.8% |
-294.3% |
-45.5% |
|||
BALANCE SHEET |
||||||||
Fixed Assets |
|
|
7,730 |
15,066 |
19,949 |
33,639 |
37,623 |
|
Intangible Assets |
6,292 |
12,895 |
17,645 |
31,378 |
35,044 |
|||
Tangible Assets |
1,438 |
1,637 |
1,673 |
1,630 |
1,948 |
|||
Other |
0 |
534 |
631 |
631 |
631 |
|||
Current Assets |
|
|
83,298 |
71,509 |
92,541 |
41,352 |
22,355 |
|
Stocks |
130 |
0 |
233 |
1,366 |
3,072 |
|||
Debtors |
4,443 |
7,017 |
7,225 |
2,830 |
8,926 |
|||
Cash |
76,918 |
61,258 |
84,018 |
35,091 |
8,291 |
|||
Other (tax and derivatives) |
1,807 |
3,234 |
1,065 |
2,065 |
2,065 |
|||
Current Liabilities |
|
|
(4,501) |
(5,215) |
(7,711) |
(6,781) |
(9,230) |
|
Creditors |
(3,384) |
(3,373) |
(5,175) |
(4,245) |
(6,694) |
|||
Other creditors |
0 |
(5) |
(80) |
0 |
0 |
|||
Short term borrowings |
0 |
0 |
0 |
0 |
0 |
|||
Deferred income |
(962) |
(1,688) |
(922) |
(922) |
(922) |
|||
Provisions and other current liabilities |
(155) |
(154) |
(1,614) |
(1,614) |
(1,614) |
|||
Long Term Liabilities |
|
|
(4,283) |
(4,254) |
(2,048) |
(2,048) |
(2,048) |
|
Long term borrowings |
0 |
0 |
0 |
0 |
0 |
|||
Deferred income |
(156) |
(744) |
(1,459) |
(1,459) |
(1,459) |
|||
Provisions and other long-term liabilities |
(4,127) |
(3,510) |
(589) |
(589) |
(589) |
|||
Net Assets |
|
|
82,244 |
77,106 |
102,731 |
66,162 |
48,699 |
|
CASH FLOW |
||||||||
Operating Cash Flow |
|
|
(3,486) |
(12,135) |
(23,682) |
(35,360) |
(23,587) |
|
Net Interest |
446 |
353 |
230 |
420 |
175 |
|||
Tax |
1,929 |
1,887 |
2,912 |
1,013 |
2,654 |
|||
Capex |
(646) |
(1,005) |
(212) |
(258) |
(611) |
|||
Purchase of intangibles |
(1,976) |
(7,474) |
(71) |
(14,742) |
(5,431) |
|||
Acquisitions/disposals |
0 |
0 |
(3,677) |
0 |
0 |
|||
Financing |
0 |
13 |
39,236 |
0 |
0 |
|||
Dividends |
0 |
0 |
0 |
0 |
0 |
|||
Other |
0 |
1,644 |
0 |
0 |
0 |
|||
Net Cash Flow |
(3,733) |
(16,717) |
14,736 |
(48,927) |
(26,800) |
|||
Opening net debt/(cash) |
|
|
(81,555) |
(76,918) |
(61,258) |
(84,018) |
(35,091) |
|
HP finance leases initiated |
0 |
0 |
0 |
0 |
0 |
|||
Exchange rate movements |
(904) |
1,057 |
8,024 |
0 |
0 |
|||
Other |
0 |
0 |
0 |
0 |
0 |
|||
Closing net debt/(cash) |
|
|
(76,918) |
(61,258) |
(84,018) |
(35,091) |
(8,291) |
|
Source: Edison Investment Research, Vernalis accounts. Note: 2015 was an 18-month reporting period, thereafter 12-month reporting.
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Research: Investment Companies
Schroder AsiaPacific Fund