OSE Immunotherapeutics — Strong momentum in deal flow

OSE Immunotherapeutics (PAR: OSE)

Last close As at 19/07/2024

EUR6.83

0.20 (3.02%)

Market capitalisation

EUR150m

More on this equity

Research: Healthcare

OSE Immunotherapeutics — Strong momentum in deal flow

OSE Immunotherapeutics’ FY24 has started off with a series of major wins, significantly bolstering the company’s clinical pipeline and liquidity. We believe the partnership with AbbVie (announced in February) for OSE-230, targeting chronic inflammation, the €8.4m public funding for Tedopi secured in April and the recent expansion of its R&D agreement with Boehringer Ingelheim (BI) are all positive endorsements of OSE’s discovery platform. Moreover, we expect the c €91m in non-dilutive inflows from these announced deals to extend OSE’s cash runway into 2027 (previously 2026), an important consideration given the still tight biotech funding environment. While some optimism from these announcements is already reflected in the share price (up 88% ytd), our revised valuation for OSE (€19/share) indicates potential for further upside with the upcoming milestones, including the Phase III initiation for lead asset Tedopi and Phase II readouts for Lusvertikimab, both anticipated imminently.

Soo Romanoff

Written by

Soo Romanoff

Managing Director - Head of Content, Healthcare

Healthcare

OSE Immunotherapeutics

Strong momentum in deal flow

Business update

Pharma and biotech

6 June 2024

Price

€7.72

Market cap

€168m

€0.93/US$

Pro-forma net cash (€m) at 31 May 2024 (including the upfront payments from AbbVie and Boehringer Ingelheim)

68

Shares in issue

21.8m

Free float

65%

Code

OSE

Primary exchange

Euronext Paris

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

20.6

52.7

100.0

Rel (local)

19.7

50.5

80.8

52-week high/low

€8.36

€2.73

Business description

OSE Immunotherapeutics is based in Nantes and Paris in France and is listed on the Euronext Paris exchange. It is developing immunotherapies for the treatment of solid tumours and autoimmune diseases and has established several partnerships with large pharma companies.

Next events

Tedopi Phase III trial commencement

Q224

Lusvertikimab UC Phase II readout

Mid-2024

Analysts

Soo Romanoff

+44 (0)20 3077 5700

Jyoti Prakash, CFA

+44 (0)20 3077 5700

Dr Arron Aatkar

+44 (0)20 3077 5700

OSE Immunotherapeutics is a research client of Edison Investment Research Limited

OSE Immunotherapeutics’ FY24 has started off with a series of major wins, significantly bolstering the company’s clinical pipeline and liquidity. We believe the partnership with AbbVie (announced in February) for OSE-230, targeting chronic inflammation, the €8.4m public funding for Tedopi secured in April and the recent expansion of its R&D agreement with Boehringer Ingelheim (BI) are all positive endorsements of OSE’s discovery platform. Moreover, we expect the c €91m in non-dilutive inflows from these announced deals to extend OSE’s cash runway into 2027 (previously 2026), an important consideration given the still tight biotech funding environment. While some optimism from these announcements is already reflected in the share price (up 88% ytd), our revised valuation for OSE (€19/share) indicates potential for further upside with the upcoming milestones, including the Phase III initiation for lead asset Tedopi and Phase II readouts for Lusvertikimab, both anticipated imminently.

Year
end

Revenue
(€m)

PBT*
(€m)

EPS*
(€)

DPS
(€)

P/E
(x)

Yield
(%)

12/22

18.3

(18.0)

(0.96)

0.0

N/A

N/A

12/23

2.2

(23.2)

(1.18)

0.0

N/A

N/A

12/24e

103.7

72.1

3.32

0.0

2.4

N/A

12/25e

82.7

51.1

2.35

0.0

3.4

N/A

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

H124 uptick driven by new partnerships

The latest company release summarises the key milestones in H124 to date, led by new partnering deals with AbbVie and BI and capped by €8.4m in public-sector funding to support the accelerated development of its clinical programme for lead cancer vaccine Tedopi. Partnered programmes have been an integral part of OSE’s development pipeline (existing deals with Veloxis and BI prior to FY24), and we believe the recent deals further validate OSE’s capabilities in immuno-oncology and immuno-inflammation. We estimate that the combined inflows from the upfront payments from AbbVie (US$48m) and BI (€38.8m), as well as the public grant, will support runway extension into 2027, in line with management guidance.

New appointments to support the next growth phase

The next few months are likely to be critical for OSE’s internal development programmes with the expected initiation of the pivotal Phase III trial for Tedopi and the anticipated Phase II results for Lusvertikimab in ulcerative colitis (UC). OSE reiterated its plans to appoint four new independent directors (pharma and corporate experts, to be proposed at the shareholder meeting on 19 June 2024) to support its positioning and strategy for the upcoming period. These include Markus Goebel, MD; Martine George, MD; Cécile Nguyen-Cluzel and Marc Dechamps.

Valuation: Upgrades to €413m or €19.0 per share

Our valuation upgrades to €413m or €19.0/share (from €317m or €14.6/share), as we adjust our FY24 and FY25 estimates as well as pro-forma net cash for the upfront payments from the new deals with AbbVie and BI. Our FY25 estimates also benefit from the €17.5m milestone payment from the new BI deal, which we expect to be received in 2025.

Riding on strong H124 growth momentum

Partnered programmes have been a key component of OSE’s development plan and we believe that the two deals in H124 will provide further impetus to this growth strategy by not only expanding the company’s product pipeline but also providing nondilutive capital, which could be deployed to advance its in-house assets. We present a summary of the recent partnership deals below.

AbbVie: For OSE-230, a preclinical novel monoclonal antibody

In February 2024, OSE announced a global licence and collaboration agreement with AbbVie to develop OSE-230, a novel monoclonal antibody, for the treatment of chronic inflammation. OSE-230 is a product from the company’s myeloid platform and has been designed to activate ChemR23, a G-protein coupled receptor target. It is understood that ChemR23 activation may offer a novel mechanism of action for the treatment of inflammation by modulating the function of macrophages and neutrophils. Previously (October 2020), OSE shared encouraging preclinical data showing that OSE-230 successfully targeted receptors associated with restoring tissue homeostasis. The antibody therapy demonstrated inflammation resolution in vivo in models for acute inflammation, chronic colitis, type 1 diabetes and multiple sclerosis. AbbVie has now assumed full development of the asset, against which OSE received upfront payment of US$48m (c €44m) with the potential to earn up to US$665m further in milestone payments. OSE is also eligible to receive potential tiered royalty payments based on global net sales of the treatment. In April 2024, the licensing agreement cleared the required review of US regulatory bodies.

Boehringer Ingelheim: Two new projects

OSE’s previous partnership with BI has focused on the evaluation and development of BI 765063 and BI 770371, two immuno-oncology anti-SIRPα monoclonal antibodies. These candidates are designed to inhibit the checkpoints between tumour cells and myeloid cells. BI 765063 is being explored in a Phase Ib study in various combinations for the treatment of head and neck squamous cell carcinoma and hepatocellular carcinoma. For BI 7770371, the first clinical results were presented in October 2023 for the ongoing open-label, dose escalation/dose expansion Phase I study in patients with solid tumours. Updates on this programme (including plans for a potential Phase II programme) are anticipated within 2024. As of March 2024, OSE had received €65m from a possible €1.1bn in development, regulatory and sales-related milestone payments.

More recently, in May 2024, OSE announced a considerable expansion of the initial collaboration and licence agreement, with two new projects planned. The first project aims to expand the utility of BI 765063 and BI 770371 to the potential application of addressing cardiovascular-renal-metabolic diseases; BI intends to launch an investigatory Phase II trial by end-2024. The second project will form a new preclinical programme to develop immune-cell activating treatments based on OSE’s cis-targeting anti-PD1/cytokine platform. Under the new collaboration terms, BI will make a one-time payment of €25.3m to OSE as a partial royalty buyout to expand the deal terms for BI 765063 and BI 770371. Furthermore, BI has the option for an additional buyout on further development, potentially triggering another one-time payment to OSE and an additional sales milestone. For the new programme for immune-cell activating treatments based on the cis-targeting anti-PD1/cytokine platform, BI will pay €13.5m upfront and a further potential €17.5m in near-term milestone payments for the purchase of the novel, cis-targeting anti-PD-1/cytokine asset in preclinical stage. We note that for the previous agreement, the original terms for up to €1.1bn in development, regulatory and sales milestone payments remain in place.

Encouraging data from Veloxis-partnered programme

In addition to its partnering deals with AbbVie and BI, OSE also has an ongoing partnership with transplant medicine specialist Veloxis Pharmaceuticals (an Asahi Kasei company) for FR104/VEL101. The compound, which is under development, is an anti-CD28 monoclonal antibody with a dual mechanism of action, directly blocking CD28-mediated T cell activation and at the same time indirectly allowing for CTLA-4 mediated immunosuppressive functions. Adequate immunosuppression is central to successful organ transplants and FR104’s dual action may provide differentiation to other available immunosuppressants. The deal with Veloxis was signed in April 2021, transferring global development, manufacturing and commercial rights to Veloxis for FR104 in all transplant indications. The deal terms included €7m in upfront payment, up to €308m in milestones and tiered royalties on sales. Of this, OSE has already received €13.9m in milestones to March 2024. Note that OSE continues to hold the right to develop FR104 in autoimmune indications. Veloxis is preparing for a Phase II study evaluating FR104 for prophylaxis of organ rejection in organ transplant patients.

FR104 is also being tested in a Phase I/II trial (FIRsT study) as a maintenance therapy for patients following kidney transplant, in collaboration with the University Hospital of Nantes, the trial sponsor. OSE recently reported positive top-line data from the study at the Annual American Transplant Congress held in Philadelphia. The study included a total of 10 kidney transplant patients at low risk of rejection, of which eight evaluable patients were treated with FR104 over a one-year treatment protocol after transplantation. Notably, Tacrolimus (a calcineurin inhibitor), the standard of care immunosuppressant to prevent organ rejection, was discontinued for these patients six-months post transplantation. The final results demonstrated a desirable safety for the treatment with no cases of acute rejection in the eight evaluable patients over the one-year treatment period, even after the discontinuation of Tacrolimus. Calcineurin inhibitors, while effective immunosuppressants, come with significant side-effects (including renal failure and neurotoxic effects) and a safer alternative such as FR104 could present an effective treatment alternative, in our opinion. OSE expects the study results to guide dose selection for a subsequent Phase II trial.

Financials and valuation

We have updated our FY24 revenue estimates for the €38.8m in upfront payments from the updated BI deal as well as €8.4m in non-dilutive public funding from Bpifrance (a French public sector financing institution). Note that our estimates already reflected the €44m payment received earlier from AbbVie. We also expect the company to receive the €17.5m in near-term milestone payments (for the purchase of the cis-targeting anti-PD-1/cytokine asset) in 2025 and we have therefore adjusted our FY25 top-line estimates to reflect this. Our revised revenue estimates for FY24 and FY25 are €103.7m and €82.7m, respectively. We have kept our operating expense estimates unchanged as we expect the partners to shoulder the expenses related to further development activities for the partnered programmes. We now estimate OSE to bring in €74.2m and €52.9m in operating profit for FY24 and FY25, respectively (€27.4m and €35.7m previously).

OSE had gross cash of €18.7m at the end of FY23 (net debt of €23.2m including €41.9m in interest-bearing liabilities), which has been bolstered by the upfront payments from AbbVie and BI as well as the non-dilutive funding received for Tedopi. We expect the c €91m in additional funds to extend the company’s cash runway into 2027, in line with management guidance. This does not consider further licensing or milestone-related inflows from partners, which should widen the runway further.

Reflecting these adjustments, our valuation for OSE upgrades to €413m or €19/share, from €317m or €14.6/share previously. Exhibit 1 presents a breakdown our valuation for the company.

Exhibit 1: Sum-of-the-parts OSE valuation

Product

Launch

Peak sales (€m)

NPV
(€m)

NPV/share (€)

Probability

rNPV
(€m)

rNPV/share (€)

Tedopi – NSCLC

2028

549

421.8

19.4

48%

190.7

8.8

OSE-127 – ulcerative colitis

2028

833

306.5

14.1

17%

55.3

2.5

BI 765063 – multiple cancer indications (MSS CRC)

2029

521

192.0

8.8

14%

38.4

1.8

FR-104 – Veloxis deal milestones (kidney transplantation)

2029

93

142.0

6.5

17%

26.3

1.2

OSE-279 solid tumours (SCLC)

2029

422

199.3

9.2

14%

34.9

1.6

Pro-forma net cash at 31 May 2024

68.0

3.1

100%

68.0

3.1

Valuation

 

 

1,329.6

61.1

 

413.5

19.0

Source: Edison Investment Research

Exhibit 2: Financial summary

€000s

2021

2022

2023

2024e

2025e

Year end 31 December

IFRS

IFRS

IFRS

IFRS

IFRS

PROFIT & LOSS

Revenue

 

26,306

18,302

2,227

103,686

82,718

Cost of Sales

0

0

0

0

0

Gross Profit

26,306

18,302

2,227

103,686

82,718

Research and development

(30,550)

(26,893)

(17,158)

(23,177)

(23,291)

Overhead expenses

(8,608)

(6,673)

(6,015)

(6,316)

(6,505)

EBITDA

 

(13,601)

(14,992)

(19,566)

75,349

54,125

Operating Profit (before amort. and excepts.)

 

(16,625)

(18,478)

(22,986)

74,194

52,922

Intangible Amortisation

0

0

0

0

0

Exceptionals

0

0

0

0

0

Other

0

0

0

0

0

Operating Profit

(16,625)

(18,478)

(22,986)

74,194

52,922

Net Interest

(589)

455

(235)

(2,052)

(1,854)

Profit Before Tax (norm)

 

(17,214)

(18,023)

(23,221)

72,141

51,068

Profit Before Tax (reported)

 

(17,214)

(18,023)

(23,221)

72,141

51,068

Tax

364

263

218

0

0

Profit After Tax (norm)

(17,214)

(18,023)

(23,221)

72,141

51,068

Profit After Tax (reported)

(16,850)

(17,760)

(23,003)

72,141

51,068

Average Number of Shares Outstanding (m)

18.2

18.5

19.6

21.7

21.8

EPS - normalised (c)

 

(94.82)

(97.28)

(118.70)

332.30

234.60

EPS - reported (€)

 

(0.93)

(0.96)

(1.18)

3.32

2.35

Dividend per share (€)

0.0

0.0

0.0

0.0

0.0

Gross Margin (%)

100.0

100.0

100.0

100.0

100.0

EBITDA Margin (%)

N/A

N/A

N/A

72.7

65.4

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

N/A

N/A

N/A

71.6

64.0

BALANCE SHEET

Fixed Assets

 

57,670

54,580

51,576

50,771

50,017

Intangible Assets

51,122

48,784

46,401

45,591

44,780

Tangible Assets

926

743

464

469

526

Investments

5,622

5,053

4,711

4,711

4,711

Current Assets

 

44,205

37,200

30,478

103,127

151,190

Stocks

0

0

0

1

1

Debtors

772

403

982

1,031

1,083

Cash

33,579

25,620

18,672

91,271

139,283

Other

9,854

11,177

10,824

10,824

10,824

Current Liabilities

 

16,762

16,268

18,799

19,264

19,752

Creditors

9,607

8,539

9,299

9,764

10,252

Short term borrowings

1,611

3,093

6,403

6,403

6,403

Other

5,544

4,636

3,097

3,097

3,097

Long Term Liabilities

 

37,224

42,855

40,280

36,874

32,628

Long term borrowings

30,801

37,231

35,508

32,647

28,924

Deferred tax liabilities

1,748

1,514

1,311

1,311

1,311

Other long term liabilities

4,675

4,110

3,461

2,916

2,393

Net Assets

 

47,889

32,657

22,975

97,759

148,827

CASH FLOW

Net income

 

(16,850)

(17,760)

(23,003)

72,141

51,068

Movements in working capital

 

1,025

(3,142)

(835)

416

437

Depreciation and other

3,024

3,486

3,420

1,155

1,203

Net Interest

634

(3,066)

(657)

0

0

Tax

(696)

(499)

(435)

0

0

Others

2,944

2,728

1,746

0

0

Net Cash Flows from Operations

 

(9,919)

(18,253)

(19,764)

73,712

52,708

Capex

(472)

(274)

(232)

(350)

(450)

Acquisitions/disposals

0

0

0

0

0

Others

(355)

300

(275)

0

0

Net Cash Flow from Investing Activities

 

(827)

26

(507)

(350)

(450)

Equity Financing

265

6

11,357

2,643

0

Debt financing

15,241

11,046

2,304

(2,861)

(3,723)

Other

(549)

(785)

(337)

(545)

(523)

Dividends

0

0

0

0

0

Net Cash Flow from Financing Activities

 

14,957

10,267

13,324

(763)

(4,246)

Effect of FX

0

0

0

0

0

Net Cash Flow

 

4,211

(7,960)

(6,947)

72,599

48,012

Opening net debt/(cash)

 

(12,766)

(1,167)

14,704

23,239

(52,221)

Change in debt

15,810

7,912

1,587

(2,861)

(3,723)

Change in cash

(4,211)

7,960

6,947

(72,599)

(48,012)

Closing net debt/(cash)

 

(1,167)

14,704

23,239

(52,221)

(103,956)

Source: Company reports, Edison Investment Research

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This report has been commissioned by OSE Immunotherapeutics and prepared and issued by Edison, in consideration of a fee payable by OSE Immunotherapeutics. Edison Investment Research standard fees are £60,000 pa for the production and broad dissemination of a detailed note (Outlook) following by regular (typically quarterly) update notes. Fees are paid upfront in cash without recourse. Edison may seek additional fees for the provision of roadshows and related IR services for the client but does not get remunerated for any investment banking services. We never take payment in stock, options or warrants for any of our services.

Accuracy of content: All information used in the publication of this report has been compiled from publicly available sources that are believed to be reliable, however we do not guarantee the accuracy or completeness of this report and have not sought for this information to be independently verified. Opinions contained in this report represent those of the research department of Edison at the time of publication. Forward-looking information or statements in this report contain information that is based on assumptions, forecasts of future results, estimates of amounts not yet determinable, and therefore involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of their subject matter to be materially different from current expectations.

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General disclaimer and copyright

This report has been commissioned by OSE Immunotherapeutics and prepared and issued by Edison, in consideration of a fee payable by OSE Immunotherapeutics. Edison Investment Research standard fees are £60,000 pa for the production and broad dissemination of a detailed note (Outlook) following by regular (typically quarterly) update notes. Fees are paid upfront in cash without recourse. Edison may seek additional fees for the provision of roadshows and related IR services for the client but does not get remunerated for any investment banking services. We never take payment in stock, options or warrants for any of our services.

Accuracy of content: All information used in the publication of this report has been compiled from publicly available sources that are believed to be reliable, however we do not guarantee the accuracy or completeness of this report and have not sought for this information to be independently verified. Opinions contained in this report represent those of the research department of Edison at the time of publication. Forward-looking information or statements in this report contain information that is based on assumptions, forecasts of future results, estimates of amounts not yet determinable, and therefore involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of their subject matter to be materially different from current expectations.

Exclusion of Liability: To the fullest extent allowed by law, Edison shall not be liable for any direct, indirect or consequential losses, loss of profits, damages, costs or expenses incurred or suffered by you arising out or in connection with the access to, use of or reliance on any information contained on this note.

No personalised advice: The information that we provide should not be construed in any manner whatsoever as, personalised advice. Also, the information provided by us should not be construed by any subscriber or prospective subscriber as Edison’s solicitation to effect, or attempt to effect, any transaction in a security. The securities described in the report may not be eligible for sale in all jurisdictions or to certain categories of investors.

Investment in securities mentioned: Edison has a restrictive policy relating to personal dealing and conflicts of interest. Edison Group does not conduct any investment business and, accordingly, does not itself hold any positions in the securities mentioned in this report. However, the respective directors, officers, employees and contractors of Edison may have a position in any or related securities mentioned in this report, subject to Edison's policies on personal dealing and conflicts of interest.

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AUSTRIACARD — Outlook points to H2-weighted growth

AUSTRIACARD reported adjusted revenue growth of 1.4% for Q124, reflecting comparison to a particularly strong Q123. Better sales mix and good control over the cost base resulted in expansion of the adjusted EBITDA margin to 15.2% (+0.1pp y-o-y). Contracts signed in all three business areas should drive revenue acceleration from Q2, providing support for management’s target of 10% growth in adjusted revenue in FY24. We revise our forecasts to reflect management guidance, higher working capital and the recent LSTech acquisition, resulting in small reductions in our EPS forecasts.

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