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Philogen Earnings Release 2023

Sep 28, 2023

4385_rns_2023-09-28_101412e0-10b2-4f05-b186-1a5949b63943.pdf

Earnings Release

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PHILOGEN S.p.A. (COURTESY ENGLISH TRANSLATION)

BOARD OF DIRECTORS APPROVES HALF-YEAR FINANCIAL REPORT AS OF JUNE 30, 2023

  • Revenues from contracts with customers amounting to 21,625 thousand euros (18,085 thousand euros in 2022)
  • Positive EBITDA of Euro 8,632 thousand (positive for Euro 9,049 thousand in 2022)
  • Positive EBIT of 6,928 thousand euros (positive 7,800 thousand euros in 2022)
  • Positive net income of 7,672 thousand Euro (positive net income of 1,980 thousand Euro as of June 30, 2022)
  • Net financial position positive 79,069 thousand Euro (positive 70,438 thousand Euro as of December 31, 2022)

Siena (Italy), Sept. 28, 2023-The Board of Directors of Philogen S.p.A. (the "Company" or "Philogen") and, together with its Swiss subsidiary Philochem, (the "Group"), which met today under the chairmanship of Dr. Duccio Neri, approved the condensed consolidated half-year financial statements as of June 30, 2023, prepared in accordance with IAS/IFRS.

Dario Neri, CEO of Philogen, commented on the results for the year and the evolution of the business:

"The first half of 2023 was marked by several significant events for the Philogen Group.

An Independent Central Review Committee is finalizing the analysis of results for the Phase III trial of Nidlegy™ in locally advanced melanoma. We expect the final results to be available in the next few weeks and then announced immediately in a separate press release. The data from Nidlegy™ in basal cell carcinoma (BCC) continues to be very promising. We are excited about these results, taking into account also the great medical need to address BCC. If the registration trials in skin cancer are successful, Philogen will commercialize Nidlegy™ in Europe, Australia and New Zealand through the multinational company Sun Pharma, sharing postmarketing sales revenues with the latter in a ratio of approximately 50:50. In the rest of the world, Philogen reserves the rights to direct commercialization of this product.

We are also pleased with the progress of Fibromun in recurrent glioblastoma, where the drug is administered in combination with lomustine. We have completed Phase I dose escalation, reporting the excellent results in the journal Science Translational Medicine. The study has begun the Phase II registrational phase, in which we are expanding the number of centers in several European countries.

The new GMP manufacturing plant in Rosia has successfully undergone inspection by the GMP MED office of the Italian Medicines Agency (AIFA). A second inspection by AIFA's GMP API office is scheduled for October 2023.

In addition to the radiopharmaceutical 177Lu-OncoFAP-23, Philogen will also bring the nonradioactive derivative OncoFAP-GlyPro-MMAE into clinical trials. The decision was made based on the excellent results recently obtained in preclinical models. We will soon begin GMP production of OncoFAP-GlyPro-MMAE, which will be contracted to a Contract Research Organization and will take approximately 12 months. OncoFAP is a small molecule that possesses the ability to target more than 28 different tumor types. Since some tumors are more sensitive to radioactivity, and others to the effect of cytotoxic agents, we anticipate that 177Lu-OncoFAP-23 and OncoFAP-GlyPro-MMAE will have complementary market opportunities.

Between 2022 and 2023, we have announced agreements with Bracco, Google, Sun Pharma, Merck Sharp & Dohme, and IBSA. We are very pleased with the balance between proprietary and licensed products , which allows Philogen to minimize cash burn without losing the opportunity to directly commercialize some of the pipeline drugs."

CONSOLIDATED FINANCIAL STATEMENTS AS OF JUNE 30, 2023

Total Group Revenues as of June 30, 2023 amounted to 22,522 thousand Euro, an increase of approximately 11.6% compared to the period ended June 30, 2022. This item consists of (i) Revenues from contracts with customers amounting to Euro 21,625 thousand and (ii) Other Income amounting to Euro 898 thousand. The change is mainly related to revenues generated from contracts with customers and residually from the tax benefits from which the Group benefits by virtue of its research activity such as, by way of example, the research and development tax credit, the technological innovation tax credit and the industry 4.0 tax credit.

PRESS RELEASE

Operating costs mainly include costs for production materials, costs for clinical and preclinical services, personnel costs, and other operating costs, and showed an increase of approximately 24.8% from the previous period, from 11,130 thousand euros as of June 30, 2022 to 13,891 thousand euros as of June 30, 2023. This change is mainly attributable to (i) the increase in costs for materials and services related to the Group's core business activities, and (ii) the increase in personnel costs related to the hiring plan aimed at structuring the workforce of the new GMP facility and strengthening management and staff functions.

As a result of the increase in revenues and operating costs, EBITDA was essentially unchanged from the previous period, showing a slight decrease of approximately 4.6 percent, from a positive value of 9,049 thousand euros as of June 30, 2022, to a positive value of 8,632 thousand euros as of June 30, 2023.

Depreciation and amortization show an increase of approximately 36.5% compared to the period ended June 30, 2022, from € 1,249 thousand as of June 30, 2022 to € 1,704 thousand as of June 30, 2023 due to the entry into operation of investments incurred for the equipment and interconnection of the new GMP facility at the Rosia (Siena) site. It should be noted that, in line with company forecasts, the new facility came into operation during the 2022 financial year in order to carry out the mandatory activities to obtain the AIFA authorization that are necessary for the production of drugs.

EBIT, calculated as the difference between EBITDA and depreciation and amortization, showed a positive balance of 6,928 thousand euros as of June 30, 2023 (positive 7,800 thousand euros as of June 30, 2022).

Net financial management for the period ended June 30, 2023 showed a net positive result of €1,330 thousand, while it was a result of negative €4,359 thousand in the period ended June 30, 2022. The positive result for the period was mainly attributable to (i) net valuation gains of €941 thousand related to changes in the fair value of the securities portfolio, (ii) net realized capital gains of €650 thousand, (iii) net foreign exchange losses of €67 thousand, and (iv) interest expense and other charges of €194 thousand.

The change from the previous period is mainly attributable to valuation items and in particular to the fair value of financial assets, which show an improvement from the period ended June 30, 2022 due to a recovery in financial markets .

Taxes amounting to Euro 585 thousand can be attributed to (i) current taxes, calculated on the result for the period, amounting to Euro 616 thousand net of tax benefits and past losses used , and (ii) deferred taxes in the amount of Euro 33 thousand and relating to the reversal of the tax effects recognized upon transition to IAS/IFRS. It should be noted that the item shows a decrease of approximately 59.9% compared to the period ended June 30, 2022.

As a result of the above, the Group, for the period ended June 30, 2023, shows a net profit of 7,672 thousand euros, an increase of 5,692 thousand euros compared to the result for the period ended June 30, 2022.

As of June 30, 2023, the Group closes with a positive net financial position of 79,069 thousand euros, compared to a positive net financial position of 70,438 thousand euros as of December 31, 2022.

The Group ended the second quarter of 2023 with liquidity of Euro 94,302 thousand compared to Euro 82,121 thousand as of March 31, 2023 and Euro 86,200 thousand as of December 31, 2022, showing an increase of 12.3 percent compared to December 31, 2022.

The following is a table of the Philogen Group's Net Financial Debt as of June 30, 2023, prepared in accordance with ESMA Guideline 32-382-1138 of March 4, 2021 and Consob's Attention Call No. 5/21:

Figures in thousands of euros June 30 March 31, December 31,
Net financial debt 2023 2023 2022
(A) Cash and cash equivalents 20,592 3,663 8,436
(B) Cash equivalents to cash and cash equivalents. 16,000 16,000 16,000
(C) Other current financial assets 57,710 62,458 61,764
(D) Liquidity (A+B+C) 94,302 82,121 86,200
(E) Current financial debt 23 31 29
(F) Current part of non-current financial debt 1,786 1,744 1,726
(G) Net current financial debt (E+F) 1,809 1,775 1,755
(H) NET CURRENT FINANCIAL DEBT (G-D) (92,494) (80,346) (84,445)
(I) Non-current financial debt 13,424 13,615 14,007
(J) Debt instruments - - -
(K) Trade and other current payables. - - -
(L) Non-current financial debt (I+J+K) 13,424 13,615 14,007
(M) NET FINANCIAL DEBT (H+L) (79,069) (66,731) (70,438)

Between the first and second quarters of 2023, the positive net financial position shows a percentage increase of about 18.5%, rising from €66,731 thousand as of March 31, 2023 to €79,069 thousand as of June 30, 2023. During the same period, liquidity increased from Euro 82,121 thousand as of March 31, 2023 to Euro 94,302 thousand as of June 30, 2023, showing an increase of approximately 14.8%. The latter change is mainly attributable to (i) collections from contracts with customers in the amount of Euro 20,470 thousand, (ii) outflows for core operations in the amount of approximately Euro 7,235 thousand, (iii) outflows for investments related to the construction of the new office building at the Rosia (Siena) site in the amount of approximately Euro 1.146 thousand, (iv) outlays for the purchase of treasury shares of Euro 609 thousand, and (v) the positive change in financial operations of approximately Euro 701 thousand given by Euro 394 thousand related to the collection of coupons that occurred in the second quarter of 2023, Euro 299 thousand related to the change in the fair value of the securities portfolio held, and Euro 8 thousand related to the change in the market to market of the hedging derivative on outstanding loans.

Current and non-current financial debt decreased from 15,390 thousand euros as of March 31, 2023, to 15,233 thousand euros as of June 30, 2023, showing a decrease of approximately 0.50% resulting from the progress of existing amortization schedules. It should be noted that the financial debt derives, for approximately 12,010 thousand Euro, from the real estate leases for the three company sites, represented according to international accounting standards (IFRS 16). The remainder, amounting to €3,200 thousand, relates to two outstanding loans entered into to partially finance the expansion project of the Rosia (Siena) production site.

MAJOR EVENTS AFTER THE PERIOD ENDED JUNE 30, 2023

Purchase of own shares

The Group is continuing the share buyback program approved on May 11, 2023 by the Company's Board of Directors, which started on May 16, 2023 and has a duration of 18 months from the shareholders' approval on April 28, 2023.

Since the start of the aforementioned program, Philogen has purchased 66,771 ordinary shares (equal to 0.1644% of the share capital) for a total amount of €1,072,443.79. As of September 25, 2023, Philogen held a total of 294,541 ordinary shares (equal to 0.7253% of the share capital).

Notices pursuant to Buyback regulations are available on the Company's website (https://www.philogen.com), "Investors/Buyback" section.

Purchase of new building

In August 2023, Philogen purchased a building adjacent to its plant located in Montarioso (Siena), at which it conducts production activities according to GMP regulations for the production of experimental drugs for its clinical trials.

The location and size of the aforementioned property make it suitable for meeting the Company's future production needs. The purchased property has a potential cubic capacity of 32 thousand cubic meters and, once renovated, can be used for both the expansion of the current GMP production plant and the construction of new offices/management center.

The purchase of this property is therefore of strategic significance in the business plan that the Company is pursuing, with the aim of increasing and developing its production capacity in order to fulfill the Company's contractual obligations with third parties and related to production in accordance with GMP regulations.

FORESEEABLE DEVELOPMENT OF OPERATIONS

The forecast of various industrial programs during the second half of 2023 can be summarized as follows:

o Nidlegy™ - a biopharmaceutical product designed for the treatment of skin cancers

An Independent Central Review Committee is finalizing the analysis of results for the Phase III trial of Nidlegy ™ in locally advanced melanoma. It is expected that final results will be available in the coming weeks and will be announced immediately in a separate press release.

Patient enrollment in the U.S. Phase III study in stage IIIB/C melanoma continues in line with company expectations. As of the date of this release, 33 centers have been opened. Additional centers will be opened during 2023.

Two Phase II studies are ongoing in "High-Risk" Basal Cell Carcinoma (BCC) and other non -melanoma skin cancers. The Group has accelerated activities in BCC based on the high rate of durable complete remissions (clinical and/or pathological CR) observed in patients treated with Nidlegy™. The company is planning a meeting (so-called Scientific Advise) with the European Medicines Agency in the first half of next year. The two clinical trials also allow Nidlegy™ to be investigated in other non-melanoma skin cancers (e.g., squamous cell carcinoma, Merkel Cell Carcinoma).

As disclosed on May 30, 2023, Nidlegy™ was the subject of an exclusive marketing, licensing and supply agreement with Sun Pharma for Europe, Australia and New Zealand. Philogen retains exclusive rights for all other territories and for all indications other than skin cancer.

o Fibromun - a biopharmaceutical product, proprietary to Philogen, designed for the treatment of soft tissue sarcoma (STS) and Glioblastoma

In the European Phase III study in first-line STS in combination with doxorubicin, 22 clinical centers have opened and enrolled 75 patients of the 118 planned in the protocol. The study continues in Germany, Italy , Spain, Poland and France.

The U.S. Phase IIb study in first-line leiomyosarcoma in combination with doxorubicin is ongoing at 7 clinical centers in the United States. Leiomyosarcoma is the most common subtype of STS.

The randomized phase of the European Phase II trial in the third-line STS in combination with dacarbazine continues. As of today's date, the trial has enrolled 37 patients of the 92 planned in the protocol, and is ongoing at 8 clinical centers. Additional centers are in the process of being activated.

Regarding the Phase I/II trial in second-line Glioblastoma in combination with lomustine, Phase I is completed with 15 patients divided into 3 cohorts, and Phase II is ongoing. The latter involves the treatment of 158 patients. Data from the first Phase 1 cohort have been published in the journal Science Translational Medicine (Look et al., Sci Transl Med 2023 eadf2281). The study is currently ongoing in Switzerland and Germany. Philogen is working with the aim of opening additional centers in major European countries.

The Phase I/II/IIb trial in first-line Glioblastoma in combination with radiotherapy and temozolomide continues at the University Hospital of Zurich. As of today's date, cohort 4 of the 5 foreseen in Phase I, is ongoing.

• OncoFAP - small organic molecule with high affinity for Fibroblast Activation Protein (FAP). FAP is highly expressed in more than 90% of epithelial tumors. The Company is currently developing several pharmaceutical derivatives based on the OncoFAP ligand.

68Ga-OncoFAP (radio-diagnostic derivative) is being studied in a Phase I clinical trial in patients with solid tumors. The study has been approved by AIFA and is conducted in Italy.

PRESS RELEASE

A Philogen-sponsored clinical study of the 177Lu-OncoFAP-23 derivative (radio-therapeutic derivative) is planned to begin in late 2023/early 2024.

Experimental data obtained in several preclinical models with OncoFAP-GlyPro-MMAE (a nonradioactive derivative of OncoFAP conjugated to cytotoxic drugs) has shown excellent ability to block the growth of several tumor types. On this basis, Philogen will begin GMP production in the coming weeks with the aim of bringing this product to the clinic.

o Products in partnerships

Partnerships continue on (i) Dodekin (Confidential Partner), (ii) Dekavil (Pfizer), and (iii) small organic molecules (Janssen and Bracco), and (iv) Nidlegy™ (Sun Pharma and MSD).

o New GMP Plant Rosia (Siena)

The first inspection of the new GMP manufacturing facility in Rosia by AIFA's GMP MED office was successful ly conducted in July 2023. A second inspection by AIFA's GMP API office is scheduled for late October 2023. The latter is aimed at approving the new GMP facility for both experimental and commercial purposes. It should be noted that this facility will complement the existing GMP plant at the Montarioso (Siena) site, which is dedicated to the production of experimental drugs.

The Group is, in addition, consolidating its core business by conducting experimental clinical trials with its proprietary drugs, and at the same time planning industrial activities aimed at the commercialization of its drugs.

* * *

Pursuant to Article 154-bis, paragraph 2, of Legislative Decree No. 58/1998, the Financial Reporting Officer, Laura Baldi, declares that the accounting information contained in this press release corresponds to the documentary results, books and accounting records.

* * *

In line with the recommendations contained in the ESMA/2015/1415 guidelines of October 5, 2015, it should be noted that within the scope of this press release there are some indicators that, although not envisaged by IFRS, are derived from financial quantities envisaged by IFRS. These indicators - which are presented in order to allow a better assessmen t of the Group's operating performance - should not be considered as alternatives to those provided for by IFRS and are homogeneous with those reported in the Report and Financial Statements as of December 31, 2020. It should also be noted that the methods for determining the indicators applied therein may not be homogeneous with those adopted by others since they are not specifically regulated by the relevant accounting standards, and therefore, these indicators may not be adequately comparable. In compliance with Consob Communication No. 9081707 of September 16, 2009, it should be noted that the alternative performance indicators have not been audited by the Auditing Firm, as have the accompanying financial statements.

* * *

Philogen Group Description.

Philogen is an Italian-Swiss company active in the biotechnology sector, specializing in the research and development of pharmaceutical products for the treatment of highly lethal diseases. The Group mainly discovers and develops targeted anticancer drugs by exploiting high-affinity ligands for tumor markers (also called tumor antigens). These ligands - human monoclonal antibodies or small organic molecules - are identified using Antibody Phage Display Libraries and DNA-Encoded Chemical Library technologies.

The Group's main therapeutic strategy for the treatment of such diseases is the so -called tumor targeting. This approach is based on the use of ligands capable of selectively delivering very potent therapeutic active ingredients (such as, for example, pro-inflammatory cytokines) at the tumor mass, sparing healthy tissues. Over the years, Philogen has mainly developed monoclonal antibody-based ligands that are specific for antigens expressed in tumor-associated blood vessels but not expressed in blood vessels associated with healthy tissues. These antigens are usually more abundant and more stable than those expressed directly on the surface of tumor cells. This approach, so -called vascular targeting, is used for most of the projects pursued by the Group.

The Group's goal is to generate, develop, and commercialize innovative products for the treatment of diseases for which medical science has not yet identified satisfactory therapies. This is achieved by leveraging (i) proprietary technologies for the isolation of ligands that react with antigens present in specific diseases, (ii) experience in developing products targeted to the tissues affected by the disease, (iii) experience in drug manufacturing and development, and (iv) the Group's extensive portfolio of patents and intellectual property rights.

Although the Group's drugs are primarily oncology applications, the targeting approach is also potentially applicable to other diseases, such as certain chronic inflammatory diseases.

* * *

FOR MORE INFORMATION:

Philogen - Investor Relations

[email protected] - Emanuele Puca | Investor Relations

Philogen Group

RECLASSIFIED CONSOLIDATED INCOME STATEMENT AS OF JUNE 30, 2023

Figures in thousands of euros and in percent As of June 30 Variations
2023 % 2022 % 2023 vs.
2022
%
Revenue from contracts with customers 21,625 100.0% 18,085 100.0% 3,540 19.6%
Other income 898 4.2% 2,094 11.6% (1,197) (57.1)%
Total Revenues 22,522 104.2% 20,179 111.6% 2,344 11.6%
Operating costs (*) (13,891) (64.2)% (11,130) (61.5)% (2,761) 24.8%
EBITDA (**) 8,632 39.9% 9,049 50.0% (417) (4.6)%
Depreciation (1,704) (7.9)% (1,249) (6.9)% (456) 36.5%
EBIT 6,928 32.0% 7,800 43.1% (873) (11.2)%
Financial income 3,119 14.4% 985 5.4% 2,135 216.8%
Financial charges (1,790) (8.3)% (5,344) (29.5)% 3,554 (66.5)%
Earnings before taxes 8,257 38.2% 3,441 19.0% 4,816 140.0%
Taxes (585) (2.7)% (1,461) (8.1)% 876 (59.9)%
Profit (Loss) for the period 7,672 35.5% 1,980 10.9% 5,692 287.5%

(*) Operating Costs are given by the sum of the following balance sheet items: purchases of raw materials and consumables, costs for services, costs for use of third-party assets, personnel costs, and other operating costs.

(**) EBITDA is earnings before taxes before depreciation, amortization and financial income and expenses. EBITDA is a measure defined and used by the Group to monitor and evaluate the Group's operating performance, but it is not defined in the IFRS framework; therefore, it should not be considered as an alternative measure for evaluating the Group's operating performance. The Company believes that EBITDA is an important metric for measuring the Group's performance because it allows the Group's margins to be analyzed by eliminating the effects arising from nonrecurring economic elements. Since EBITDA is a measure which is not regulated by the relevant accounting standards for the preparation of the Group's consolidated financial statements, the criteria applied to determine EBITDA may not be homogeneous with that adopted by other groups, and therefore may not be comparable.

Philogen Group

RECLASSIFIED CONSOLIDATED BALANCE SHEET AS OF JUNE 30, 2023

Figures in thousands of euros and in percent As of June 30 As of December
31
Variations
2023 2022 2023 vs. 2022 %
Assets
Property, plant and equipment 13,046 12,699 347 2.7%
Intangible assets 1,287 1,218 69 5.7%
Activities by right of use 9,988 9,862 126 1.3%
Other non-current assets 3,424 2,987 437 14.6%
Deferred tax assets 133 98 35 35.2%
Employee benefits (1,032) (960) (72) 7.6%
Other non-current liabilities (1,739) (1,962) 223 (11.4)%
Deferred tax liabilities (168) (191) (23) (11.9)%
Net
fixed assets (*)
24,939 23,751 1,187 5.0%
Inventories 2,533 1,922 610 31.7%
Activities arising from contract 786 2,300 (1,514) (65.8)%
Trade receivables 1,052 885 167 18.9%
Tax credits 7,132 6,796 336 4.9%
Other current assets 1,212 860 352 40.9%
Trade payables (7,969) (6,352) (1,617) 25.5%
Liabilities arising from contract (372) - (372) -
Tax debts (1,157) (669) (487) 72.8%
Other current liabilities (2,381) (2,010) (371) 18.5%
Net
working capital (*)
836 3,732 (2,896) (77.6)%
Net invested capital (*) 25,775 27,483 (1,709) (6.2)%
Sources
Shareholders' Equity 104,844 97,921 6,923 7.1%
Net financial debt (*) (79,069) (70,438) (8,631) 12.3%
Total sources 25,775 27,483 (1,709) (6.3)%

(*) Net fixed assets, net working capital, net invested capital, and net financial debt are alternative performance indicators that are not identified as accounting measures under IFRS and, therefore, should not be considered alternative measures to those provided by the Group's financial statement formats for assessing the Group's financial position.

Philogen Group

CONSOLIDATED CASH FLOW STATEMENT AS OF JUNE 30, 2023

Figures in thousands of Euros
2023 Of which with
related
parties
2022 Of which
with related
parties
Cash flow from operating activities
Result for the period 7,672 (2,707) 1,980 (1,548)
Adjustments for:
Depreciation of tangible and intangible assets 1,704 (798) 1,249 375
Net financial income/(expense) (1,330) (344) 4,359 171
Provisions for funds and employee benefits 113 96
Provisions for group incentive plans. 122 38
Income taxes 585 1,461
Other non-cash adjustments (431) (182)
Variations of:
Inventories (610) (626)
Activities arising from contract 1,514 (612)
Trade receivables 9 (642) 16
Liabilities arising from contract 372 (505)
Trade payables 1,612 (3) 548 (34)
Other assets and liabilities (*) (747) 124 (1,517)
Use of funds and employee benefits (22) (2)
Interest paid (259) (345)
Income taxes paid - -
Cash flow generated/(absorbed) from operations (A) 10,305 (4,369) 5,959 (1,037)
Cash flow from investing activities
Interest collected 733 16
Proceeds from the sale of financial assets 5,162 2,666
Purchase of property, plant and equipment (1,518) (3,259)
Purchase of intangible assets (160) (216)
Purchase of other financial assets (302) -
Cash flow generated/(absorbed) by investing activities (B) 3,935 - (792) -
Cash flows from financing activities
Proceeds from the issuance of shares - -
Receipts from the assumption of financial liabilities - -
Repayment of financial liabilities (409) (628)
Payment of lease liabilities (480) (410) (388) (370)
Purchase of own shares (1,196) (1,594)
Cash flow generated/(absorbed) by financing activities (C) (2,085) (410) (2,610) (370)
Total cash flow (A + B + C + D) 12,155 (4,778) 2,557 (1,407)
Beginning cash and cash equivalents 24,436 8,880
Change in cash and cash equivalents for the period 12,155 2,557
Translation effect on cash and cash equivalents 1 29
Closing cash and cash equivalents 36,592 11,466

(*) Includes: other non-current assets, other current assets, other non-current liabilities, other current liabilities, tax payables and receivables.