Genticel — Update 28 June 2016

Genticel — Update 28 June 2016

Genticel

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Genticel

Further Phase II data announced

18-month Phase II results

Pharma & biotech

28 June 2016

Price

€1.71

Market cap

€27m

US$1.10/€

Cash and equivalents (€m) at 31 March 2016

18.8

Shares in issue

15.5m

Free float

45%

Code

GTCL

Primary exchange

Euronext

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

(62.0)

(56.8)

(78.2)

Rel (local)

(56.9)

(52.9)

(72.5)

52-week high/low

€7.8

€1.7

Business description

Genticel is developing a therapeutic vaccine, GTL001, to treat early-stage, high-risk HPV 16 and 18 infections. Further 24-month Phase II data due in Q117 will provide more information for next steps. A multivalent therapeutic vaccine, GTL002, is in late preclinical development.

Next events

In-licensing activities

H217

SIIL milestones

H216

24-month Phase II data

Q117

Analysts

Juan Pedro Serrate

+44 (0)20 3681 2534

Lala Gregorek

+44 (0)20 3681 2527

Genticel is a research client of Edison Investment Research Limited

Genticel has announced 18-month data from the Phase II trial of the GTL001 vaccine to treat early-stage human papillomavirus 16 and 18 infections (HPV16/18). In this update, GTL001 showed no statistically significant difference in any subgroup. Safety remains positive. Genticel will present 24-month data in Q117, which will include the full data set and inform next steps. The company continues leveraging its Vaxiclase platform in collaboration with the Serum Institute of India (SIIL) and plans to expand its pipeline. We have revised our valuation down to €2.31/share (€5.75/sh previously) as we have cut the probability of success for GTL001.

Year end

Revenue
(€m)

PBT*
(€m)

EPS*
(c)

DPS
(c)

P/E
(x)

Yield
(%)

12/14

0.00

(10.81)

(78.1)

0.0

N/A

N/A

12/15

0.18

(11.19)

(72.1)

0.0

N/A

N/A

12/16e

0.00

(8.66)

(55.8)

0.0

N/A

N/A

12/17e

0.00

(8.30)

(53.4)

0.0

N/A

N/A

Note: *PBT and EPS are normalised, excluding intangible amortisation, exceptional items and share-based payments. 2014 restated due to IFRS adjustments.

18-month Phase II data released

Genticel has announced further data from its Phase II trial in HPV16/18 positive women. After 18 months, neither the predefined nor the post-hoc groups showed a statistically significant viral clearance rate vs placebo. Although GTL001 has shown biological activity, it has missed significance due in part to the small number of patients. In consequence, the company will wait until the full data set is available at 24 months, which is expected in Q117. Notably, no safety issues have arisen.

Rethinking the steps ahead

While a partnership focused on advancing the candidate into pivotal Phase III trials is now less likely, the lessons learnt from the fully completed trial could allow a partnership to assess GTL001 in a new Phase II trial focused on a specific subgroup of patients that have shown a sufficiently robust signal. A partnership could also be focused on preparing the next-generation candidate GTL002 for Phase I.

Vaxiclase platform provides potential upside

Genticel also has the Vaxiclase antigen delivery platform, which will continue to develop in collaboration with SIIL for multivalent vaccine applications. The company will engage in business development activities and announce the addition of new products to its pipeline in the next six months.

Valuation: New rNPV of €2.31 vs previous €5.75

We lower the Phase II probability for women with normal cytology from 40% to 20% and the partnering probability from 55% to 20%. Hence, we adjust our valuation to €2.31/share vs previous €5.75/share before dilution (€2.11 vs €5.26 including dilution). Our financials remain unchanged. Assuming the same cash burn rate as Q116, the estimated net cash and equivalents at end Q216 are €15.8m, which provides enough runway until mid-2018.

Exhibit 1: Financial summary

€000

2014

2015

2016e

2017e

Year End December

IFRS

IFRS

IFRS

IFRS

PROFIT & LOSS

Revenue

 

 

0

178

0

0

Cost of Sales

0

0

0

0

Gross Profit

0

178

0

0

EBITDA

 

 

(10,885)

(11,361)

(8,760)

(8,300)

Operating Profit (before amort. and except.)

 

(10,912)

(11,412)

(8,810)

(8,350)

Intangible Amortisation

(8)

(4)

(5)

(5)

Exceptionals

0

0

0

0

Other

0

0

0

0

Operating Profit

(10,920)

(11,417)

(8,815)

(8,355)

Net Interest

105

223

150

50

Profit Before Tax (norm)

 

 

(10,808)

(11,189)

(8,660)

(8,300)

Profit Before Tax (FRS 3)

 

 

(10,815)

(11,193)

(8,665)

(8,305)

Tax

0

0

0

0

Profit After Tax (norm)

(10,780)

(11,137)

(8,610)

(8,250)

Profit After Tax (FRS 3)

(10,815)

(11,193)

(8,665)

(8,305)

Average Number of Shares Outstanding (m)

13.8

15.4

15.4

15.4

EPS - normalised (c)

 

 

(78.1)

(72.1)

(55.8)

(53.4)

EPS - (IFRS) (c)

 

 

(78.4)

(72.5)

(56.1)

(53.8)

Dividend per share (p)

0.0

0.0

0.0

0.0

Gross Margin (%)

NA

NA

NA

NA

EBITDA Margin (%)

NA

NA

NA

NA

Operating Margin (before GW and except.) (%)

NA

NA

NA

NA

BALANCE SHEET

Fixed Assets

 

 

228

457

457

457

Intangible Assets

19

52

52

52

Tangible Assets

95

156

156

156

Fixed term investments

10,076

5,043

5,043

0

Other

114

249

249

249

Current Assets

 

 

25,899

20,388

11,176

7,319

Stocks

31

53

53

53

Debtors

236

714

714

714

Cash

22,727

16,682

7,470

3,853

Other

2,904

2,940

2,940

2,700

Current Liabilities

 

 

(3,960)

(3,331)

(3,308)

(3,308)

Creditors

(3,448)

(2,710)

(2,708)

(2,708)

Short term borrowings

(512)

(621)

(600)

(600)

Long Term Liabilities

 

 

(2,026)

(2,223)

(1,623)

(1,023)

Long term borrowings

(1,646)

(1,901)

(1,301)

(701)

Other long term liabilities

(380)

(322)

(322)

(322)

Net Assets

 

 

20,141

15,291

6,703

3,446

CASH FLOW

Operating Cash Flow

 

 

(9,952)

(11,968)

(8,962)

(8,160)

Net Interest

105

223

150

50

Tax

0

0

0

0

Capex

(73)

(152)

(55)

(55)

Acquisitions/disposals

0

0

0

0

Equity Financing

41,353

318

0

0

Other items

(2,602)

568

(345)

(495)

Net Cash Flow

28,831

(11,010)

(9,212)

(8,660)

Opening net debt/(cash)

 

 

(2,125)

(30,645)

(19,203)

(10,612)

HP finance leases initiated

0

0

0

0

Other

(311)

(433)

621

600

Closing net debt/(cash)

 

 

(30,645)

(19,203)

(10,612)

(2,552)

Source: Edison Investment Research, Genticel accounts

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Germany

London +44 (0)20 3077 5700

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London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

245 Park Avenue, 39th Floor

10167, New York

US

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Level 25, Aurora Place

88 Phillip St, Sydney

NSW 2000, Australia

Wellington +64 (0)48 948 555

Level 15, 171 Featherston St

Wellington 6011

New Zealand

Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

245 Park Avenue, 39th Floor

10167, New York

US

Sydney +61 (0)2 9258 1161

Level 25, Aurora Place

88 Phillip St, Sydney

NSW 2000, Australia

Wellington +64 (0)48 948 555

Level 15, 171 Featherston St

Wellington 6011

New Zealand

Ceres Power Holdings — Update 28 June 2016

Ceres Power Holdings

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