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Abzena — Update 14 December 2015

Abzena — Update 14 December 2015

Abzena

Analyst avatar placeholder

Written by

Abzena

Rapid M&A and pipeline progress

M&A/portfolio update

Pharma & biotech

15 December 2015

Price

63.50p

Market cap

£86m

Net cash (£m) at 30 September 2015 (excludes £20m raise)

7.4

Shares in issue

136.1m

Free float

39%

Code

ABZA

Primary exchange

AIM

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

(3.8)

(8.0)

(19.1)

Rel (local)

(0.6)

(5.1)

(15.8)

52-week high/low

86.50p

63.50p

Business description

Abzena is a UK group that offers a range of services and technologies for biopharmaceutical development. Antitope (immunogenicity tests, protein engineering), PolyTherics (bioconjugation, polymer/synthetic chemistry), PacificGMP (biomanufacturing) and TCRS (ADC chemistry) are the operating businesses units.

Next events

Further Abzena inside products into the clinic

H116

Potential Roche update on SDP051 clinical plans

H116

Simtuzumab Phase IIb data in PSC

Mid-2016

Analysts

Tim Franklin

+44 (0)20 3077 5734

Christian Glennie

+44 (0)20 3077 5727

Abzena is a research client of Edison Investment Research Limited

Abzena’s acquisition of PacificGMP in September for £5.5m and recent purchase of TCRS for £10m significantly enhances its technology and services offering, particularly GMP manufacturing capacity. The deals are immediately accretive to the group on an EBITDA basis, with full impact on revenues and EBIT margins expected in FY17. To fund the TCRS acquisition, the company completed a £20m (net) share placement. The Abzena inside antibody clinical pipeline has increased to 10, with two new products in Phase I studies. Our fair value increases from £105m to £130m, although due to the increased share count (+38.6m shares for placing and TCRS deal) our per share value is lowered from 108p to 95p.

Year end

Revenue (£m)

PBT*
(£m)

EPS*
(p)

DPS
(p)

P/E
(x)

Yield
(%)

03/14

5.3

(3.4)

N/A

0.0

N/A

N/A

03/15

5.7

(4.7)

(5.89)

0.0

N/A

N/A

03/16e

9.1

(5.9)

(4.28)

0.0

N/A

N/A

03/17e

16.5

(2.4)

(1.53)

0.0

N/A

N/A

Note: *PBT and EPS are normalised, excluding intangible amortisation, exceptional items and share-based payments.

Synergies from PacificGMP and TCRS deals

The PacificGMP acquisition boosts the service offering and should help Abzena capture more business. It provides access to existing PacificGMP businesses in US/Asia and, more importantly, it will expand Abzena’s core contracts globally by offering greater integrated services. The proposed acquisition of TCRS will allow GMP manufacturing capability for candidates emerging from Abzena’s existing antibody-drug-conjugate (ADC) technology. Both strategic moves create a more encompassing and integrated protein development and manufacturing service that should lead to an increase in contract volumes and value.

Abzena inside – a rapidly-growing clinical pipeline

The number of composite human antibodies in clinical development, created using Abzena’s protein engineering technology for its partners, has increased from eight to 10 candidates. Two further products have been revealed (we assume Phase I), being conducted by undisclosed US pharma and US biotech companies. SDP051 will soon advance into Phase II following Roche’s $105m upfront acquisition of Adheron Therapeutics. Abzena stands to receive low single-digit royalties on the successful development and commercialisation of antibodies being fully funded by its partners. Earliest product launches from partner Gilead are slated for 2019.

Valuation: Increased to £130m

Our fair value is increased to £130m (from £105m), although reduced on a per-share basis to 95p (vs 108p) due to the 35m share placement (to raise £20m net) and 3.6m shares issued to TCRS. The key driver of our increased valuation is the higher rNPV of Services (+£20m), due to the PacificGMP and TCRS deals, and value enhancements of £5m for Abzena inside (two new antibodies in the clinic and SDP051 moving to Phase II), offset by a double-digit increase in operating costs.

Operational update and H116 results

In H116 (six months to September 2015), the company reported revenue of £3.5m, gross profit of £1.6m and operating loss of £4.0m. Adjusted for one-off costs associated with the acquisition of PacificGMP, operating loss came in at £3.5m. Revenues in the services business grew by 47% overall and 39% on a like-for-like basis. The key driver behind the revenue growth was immunology and cell line development. At the end of September, the company had £7.4m in cash.

Licensing portfolio update

There are now 10 Abzena inside antibody products in clinical development (Exhibit 4). Four of these products are being developed by three leading global biopharmaceutical companies: Gilead, Roche and one undisclosed. This is a strong endorsement of Abzena’s Composite Human Antibody technology platform and expertise in the field. Although there are inherent risks with the development of biopharma products across the industry, the development expertise and previous record of these companies in their respective disease areas should bode well for the likelihood of success of the Abzena inside portfolio.

Exhibit 4: Abzena inside – composite human antibodies in clinical development

Product

Antibody target

Company

Potential indications

Status

Notes

GS5745

MMP-9

Gilead Sciences

Gastric cancer

Phase III

430-pt Phase III initiated in November 2015, estimated to complete H218.
April 2015: Gilead announces plans to initiate a Phase III trial in gastric cancer based on highly encouraging Phase I data.

Ulcerative colitis (UC)

Phase II/III

1,600-pt Phase II/III study initiated in December 2015 in moderate-to-severe active UC; initial results estimated by mid-2018. April 2015: Gilead announces plans to initiate a Phase II/III trial based on encouraging 74-pt Phase Ib data.

Crohn's disease (CD)

Phase II

175-pt Phase II study initiated (Apr 2015) in moderate-to-severe CD; eight-week treatment period; primary endpoint = % clinical response + endoscopic response at week eight; data in H117.

Pancreatic cancer

Phase Ib

Trial ongoing (other Phase I studies also ongoing for COPD and RA).

Simtuzumab (GS-6624)

LOXL2

Gilead Sciences

Non-alcoholic steatohepatitis (NASH)

Phase IIb

2x Phase II studies initiated in 2012, with IV (n=259) and SC (n=222) formulations; enrolment complete; treatment for up to 240 weeks; primary endpoints = event-free survival (EFS); mean change in hepatic venous pressure gradient (HVPG) + morphometric collagen on liver biopsy. 70-pt Phase II trial initiated June 2015, in combination with GS-4997 (ASK-1 inhibitor); data in H216.

Primary sclerosing cholangitis (PSC)

Phase IIb

235-pt study initiated in 2013, with SC formulation; enrolment complete; 96-week treatment; primary endpoint = collagen reduction in liver biopsy.

Idiopathic pulmonary fibrosis (IPF)

Phase II

500-pt study (RAINIER) initiated in 2013 with SC formulation; 80% enrolled; treatment for up to 254 weeks; primary endpoint = progression free survival (PFS).

OPN-305

TLR2

Opsona Therapeutics

Delayed renal graft function (DGF)

Phase II

278-pt study initiated in 2012; primary endpoint = incidence of DGF/need for dialysis within first seven days following renal transplantation; data mid-2016.

Myelodysplastic syndrome (MDS)

Phase I/II

40-pt Phase I/II study initiated in Jan 2015, in 2nd-line lower risk MDS; primary endpoint = dose and frequency based on DLT toxicity; data mid-2016.

VPI-2690B

αVβ3 receptor

Vascular Pharma

Diabetic nephropathy

Phase II

Mar 2015: $9m series A extension; J&J has option to acquire on Phase II completion. 300-pt study initiated in 2014 for diabetic nephropathy in type I and II diabetic patients; 48-wk treatment period; primary endpoint = change from baseline in albuminuria; data H217.

SDP051

Cadherin-11

Roche
(Adheron Therapeutics)

Rheumatoid arthritis, fibrotic conditions (NASH), cancer

Phase II-ready

Oct 2015: Roche acquires Adheron for SDP015. We assume Phase II will begin in 2016. Jan 2014 Phase I complete; safe and well-tolerated up to 10mg/kg per day. Preclinical studies demonstrate activity across cancer, rheumatoid arthritis and fibrotic conditions including NASH.

NKTT120

iNKT cells

NKT Therapeutics

Sickle cell disease

Phase Ib

21-pt Phase I dosing/safety study ongoing; encouraging data from first 18 patients at ASH 2014; awaiting final data (H115); possible Phase II start in H215.

TBI 304H

CD163

Therapure Innovations

Chemotherapy-induced anaemia

Phase I

Mar 2015: FDA approval for a Phase I study, single-centre, open-label, dose-escalation, to evaluate safety, tolerability and pharmacokinetics of TBI 304H.

Undisclosed

N/A

US major pharma

Neurodegenerative conditions

Phase I

Undisclosed

N/A

US major pharma

Neurodegenerative conditions

Phase I

Undisclosed

N/A

US major biotech

Immune system and inflammatory disorders

Phase I

Sources: Abzena presentation (Dec 2014), press release (Apr 2015), Edison Investment Research, clinicaltrials.gov

Valuation

Our fair value is adjusted to £130m (from £105m) or 95p per share (vs 108p). The value of the services business has increased by £20m due to the acquisition of PacificGMP and TCRS as well as to an upgrade in revenues in Biomanufacturing. However, we have also factored in additional costs that will be associated with expanding the business by increasing our assumptions on group SG&A and capex.

Exhibit 5: Abzena valuation metrics and key assumptions

rNPV (£m)

rNPV per share (p)

Key assumptions

Services business

55.9

41.1

3-phase DCF: 2016-2020 (6-10% growth), 2021-2025 (2-5% growth), 2% TV on 2025 FCF (steady-state); 10% WACC; 12-15% effective tax rate; 45% COGS; 75% of Group admin expense

Licensed biological product royalties

59.3

43.5

Risked-adjusted royalties (1-5%) on partner's product sales; 12.5% WACC; 12% effective tax rate; 50% of Group R&D expense (risk-adjusted); no milestones included

Portfolio sub-total

115

85

Cash (FY16e)

14.4

10.6

FY16e (31 March 2016)

Overall valuation

130

95

136.1m shares outstanding (basic); post 35m equity issue and 3.6m issue to TCRS

Source: Edison Investment Research

Our rNPV for product royalties has increased to £59m (vs £54m) as we now include the two products with leading US companies in Phase I, and the movement of SDP051 from Phase I to Phase II in 2016. The combined effect of these changes is to add a further £5m to our licensed biological royalty line. The probability of success of the two Phase I programmes has changed to 15% (vs 5% previously for preclinical) and launch dates have been brought forwards to 2022 (vs 2023 and 2024 previously). SDP051 moves from Phase I to Phase II-ready, which increases the probability from 15% to 25%, while the estimated launch date of 2023 has been brought forwards one year to 2022 (Exhibit 6). We await further announcements from Roche on next clinical development steps with this programme before reviewing our probabilities of success and estimates for clinical timelines and peak sales.

Exhibit 6: Abzena inside – valuation assumptions by product

Product/partner

Status

Peak sales ($m)

Probability of success

Launch date

GS5745 – Gilead Sciences

Phase III

2,500

50%

2019

Simtuzumab – Gilead Sciences

Phase II

3,000

35%

2019

OPN-305 – Opsona Therapeutics

Phase II

750

35%

2020

VPI-2690B – Vascular Pharmaceuticals

Phase II

1,000

35%

2021

SDP051 – Roche/Adheron Therapeutics

Phase II-ready

1,000

25%

2022

NKT120 – NKT Therapeutics

Phase Ib

250

25%

2021

TBI 304H – Therapure Innovations

Phase I

1,000

15%

2021

US major pharma partner

Phase I

1,000

15%

2022

US Pharma

Phase I

750

15%

2022

US Biotech

Phase I

750

15%

2022

TRX-318 – Therapix Biosciences

Preclinical

1,000

10%

2023

ANX005 – Annexon Biosciences

Preclinical

750

5%

2023

New Product 1 (ADC)

Preclinical

1,000

5%

2024

New Product 2 (ADC)

Preclinical

1,000

5%

2025

New Product 3 (ADC)

Preclinical

1,000

5%

2026

Source: Edison Investment Research, Abzena

A summary of the changes to our valuation model since we initiated coverage in March 2015 is summarised in Exhibit 7, showing the rapid creation of value, which supports the overall investment case (growing and advancing partnered pipeline) and strategic rationale behind the recent deals.

Exhibit 7: Breakdown of fair value progression since March 2015

Source: Edison Investment Research

We note our valuation and financial models do not currently include the potential dilution effect from the exercise of warrants, or the issue of new shares under the performance-based incentive scheme, related to the PacificGMP and TCRS acquisitions.

For the PacificGMP acquisition the warrants cover 564,762 Abzena shares (0.58% of current issued share capital), which are valued at approximately £0.5m and valid for three years with an exercise price of 80p. Under the performance-based incentive scheme, PacificGMP's executives and key managers are eligible to receive up to 5,129,939 Abzena ordinary shares (5.3% of current issued share capital), dependant on the business's performance over the next two years.

On completion of the TCRS acquisition, Abzena will grant further restricted stock units over 901,697 ordinary shares to key employees of TCRS as part of an incentive plan, and depending on pre-agreed business targets and retention of specific employees.

Earnings revision

The main changes to our financial forecasts (Exhibit 8) are related to the recent acquisition of PacificGMP and imminent acquisition of TCRS. In the 12 months to July 2015, PacificGMP generated $3m in revenues. TCRS annualised revenue was $5.3m ($4m in 9M15) with an EBITDA margin around 23% ($0.9m 9M15).

Future revenue potential is expected to increase, given Abzena’s stronger business drive and the enhanced service offering that has resulted from the complementary integration of technology with manufacturing scale-up. We have assumed an immediate additional revenue benefit. In FY17, the first full year reflecting PacificGMP, we assume revenues of £3.4m (Pacific’s previous £2m run rate plus £0.8m additional revenues). The balance of revenues relates to expected growth in the pre-existing cell line development contract business. The addition of TCRS adds a further £5.1m to our FY17 revenues forecasts.

Exhibit 8: Changes to financial forecasts

£000s

2015

2016e

2017e

2018e

Old

New

% change

Old

New

% change

Old

New

% change

Revenues

5,667

6,688

9,071

+36%

7,462

16,530

+122%

8,161

22,467

+175%

Gross profit

3,135

3,881

4,231

+9%

4,374

8,565

+96%

4,826

11,826

+145%

Gross margin

55%

58%

47%

(20%)

59%

52%

(12%)

59%

53%

(11%)

R&D

(2,989)

(3,138)

(3,993)

+27%

(3,295)

(3,394)

+3%

(3,460)

(3,563)

+3%

SG&A

(5,634)

(5,775)

(6,956)

+20%

(5,919)

(8,347)

+41%

(6,038)

(9,599)

+59%

Op profit (before GW/Excep)

(4,795)

(4,424)

(5,987)

+35%

(4,260)

(2,506)

(41%)

(4,128)

(718)

(83%)

Net cash

15,799

12,128

14,374

+19%

8,451

9,995

+18%

4,963

8,371

+69%

Source: Edison Investment Research

Exhibit 9: Financial summary

£'000s

2014

2015

2016e

2017e

2018e

Year end 31 March

IFRS

IFRS

IFRS

IFRS

IFRS

PROFIT & LOSS

 

 

Revenue

 

 

5,261

5,667

9,071

16,530

22,467

of which: Immunology

2,196

2,940

4,238

4,662

5,035

Protein engineering

932

1,218

1,290

1,380

1,463

Bioconjugation

165

657

639

703

738

Cell line development

419

594

651

703

738

Biomanufacturing (PacificGMP)

1,091

3,382

5,073

TCRS

900

5,100

8,670

Total Service revenues

3,712

5,409

8,809

15,930

21,717

Licenses/milestones/royalties

1,549

258

262

600

750

Cost of Sales

(1,697)

(2,532)

(4,840)

(7,965)

(10,641)

Gross Profit

3,564

3,135

4,231

8,565

11,826

R&D expenses

(2,601)

(2,989)

(3,993)

(3,394)

(3,563)

SG&A expenses

(4,787)

(5,634)

(6,956)

(8,347)

(9,599)

EBITDA

 

 

(3,116)

(4,510)

(4,953)

(1,891)

474

Operating Profit (before GW and except)

 

(3,394)

(4,795)

(5,987)

(2,506)

(718)

Intangible Amortisation

(304)

(504)

(514)

(569)

(518)

Depreciation

(278)

(285)

(1,034)

(615)

(1,192)

Exceptionals

(426)

0

(2,000)

0

0

Operating Profit

(4,124)

(5,299)

(8,501)

(3,075)

(1,236)

Other

0

0

0

0

0

Net Interest

27

79

38

62

40

Profit Before Tax (norm)

 

 

(3,367)

(4,716)

(5,949)

(2,444)

(678)

Profit Before Tax (FRS 3)

 

 

(4,097)

(5,220)

(8,464)

(3,013)

(1,196)

Tax

548

498

951

362

144

Profit After Tax (norm)

(2,819)

(4,218)

(4,998)

(2,083)

(535)

Profit After Tax (FRS 3)

(3,549)

(4,722)

(7,513)

(2,652)

(1,053)

Average Number of Shares Outstanding (m)

1.4

71.6

116.8

136.1

136.1

EPS - normalised (p)

 

 

N/A

(5.89)

(4.28)

(1.53)

(0.39)

EPS - FRS 3 (p)

 

 

N/A

(6.59)

(6.43)

(1.95)

(0.77)

Dividend per share (p)

0.0

0.0

0.0

0.0

0.0

BALANCE SHEET

Fixed Assets

 

 

10,139

10,432

25,670

27,985

28,775

Intangible Assets

9,446

8,942

22,595

22,025

21,507

Tangible Assets

693

1,490

3,075

5,960

7,268

Other

0

0

0

0

0

Current Assets

 

 

5,856

20,924

20,328

15,360

13,517

Stocks

295

817

933

933

933

Debtors

2,263

3,161

4,070

4,070

4,070

Cash

2,757

15,799

14,374

9,995

8,371

Other

541

1,147

951

362

144

Current Liabilities

 

 

(1,278)

(2,354)

(4,550)

(4,550)

(4,550)

Creditors

(1,160)

(2,354)

(3,976)

(3,976)

(3,976)

Short term borrowings

0

0

0

0

0

Short term leases

0

0

0

0

0

Other

(118)

0

(574)

(574)

(574)

Long Term Liabilities

 

 

(1,183)

(1,153)

(1,088)

(1,088)

(1,088)

Long term borrowings

0

0

0

0

0

Long term leases

0

0

0

0

0

Other long term liabilities

(1,183)

(1,153)

(1,088)

(1,088)

(1,088)

Net Assets

 

 

13,534

27,849

40,359

37,707

36,655

CASH FLOW

Operating Cash Flow

 

 

(4,328)

(4,859)

(8,200)

(1,921)

444

Net Interest

0

0

0

0

0

Tax

251

(133)

982

951

362

Capex

(264)

(1,082)

(2,558)

(3,500)

(2,500)

Acquisitions/disposals

(6,133)

0

(11,712)

0

0

Financing

10,670

19,037

20,000

0

0

Dividends

0

0

0

0

0

Other

(6)

79

63

92

70

Net Cash Flow

190

13,042

(1,425)

(4,378)

(1,625)

Opening net debt/(cash)

 

 

(2,754)

(2,757)

(15,799)

(14,374)

(9,995)

HP finance leases initiated

0

0

0

0

0

Other

(187)

0

0

0

(0)

Closing net debt/(cash)

 

 

(2,757)

(15,799)

(14,374)

(9,995)

(8,371)

Source: Company accounts, Edison Investment Research

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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

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

Athersys — Update 13 December 2015

Athersys

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