Crossject: 2022 Annual Results
20/03/2023 19:34
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Press release
2022 annual results
A year of major developments
Substantial increase in operating income
Dijon, 20 March 2023, 8.00 p.m.
CROSSJECT (ISIN: FR0011716265; Ticker: ALCJ), a specialty pharma company that
is developing and will soon be marketing a portfolio of drugs for use in
emergency situations (epilepsy, allergic shock, overdose, asthma attack,
adrenal insufficiency, etc.), presents its annual results for 2022.
“In 2022, Crossject experienced a truly unprecedented year in its history.
The growth embedded in contracts signed to date offers unique visibility and
marks the turning point we have been waiting for. Optimising our resources to
support Crossject’s ramp-up is now our priority, along the lines of the
non-dilutive financing we have implemented. Thanks to the efforts of all our
teams and the support of our shareholders, especially Gemmes Venture, a major
shareholder from the early days, the Crossject story is only just beginning.
The momentum for success is there and our teams are more motivated than ever
to make us a key player in the pharma sector. Lastly, I would like to thank
our investor and shareholder Vester Finance, which hs managed its bonds with
great care in a long-term perspective.”
Patrick Alexandre – Chairman of the Management Board
With its patented needle-free self-injection system, Crossject aims to become
the world leader in self-administered emergency medication. Crossject is a
human-sized company working out of two sites (Dijon and Gray) and covering a
wide range of activities, from the design/development of medicines to the
preparation of their marketing and their manufacture.
After 20 years of research and development, Crossject has achieved major
clinical, industrial and commercial milestones in the last two years, laying
solid foundations for its future.
Emergency situations
Crossject specialises in pre-hospital emergencies. Patients diagnosed at risk
of life-threatening seizures can get a prescription for their emergency dose
from their doctor, fill the prescription in a pharmacy and then carry it with
them at all times.
People are generally not in a medical environment when they have seizures, so
they either have to inject the emergency dose themselves or have it done by a
member of their family, who is not a health professional. That is where our
ZENEO® needle-free injector comes in. ZENEO® is pre-filled and single-use,
very easy to understand and extremely safe to use. The ergonomics of our
system owe much to cooperation with patient associations for several
indications, and has been validated by more than 1,000 people in total on
countless occasions. In most cases, an injection can be performed in under a
minute, even in stressful situations or by someone unfamiliar with ZENEO®. In
the latest “human factors” study in the United States (see press release
of 12 September 2022), an exceptional proportion of 99.6% of people
successfully completed the injection.
In addition, thanks to its ability to inject the dose in less than a tenth of
a second (compared with several seconds for most conventional systems),
ZENEO® eliminates most of the risks of misuse.
Efficacy of ZENEO®
ZENEO® has a long history of proven efficacy and flexibility, with more than
10 clinical studies under its belt, including a 2014 bioequivalence study in
combination with subcutaneous methotrexate.
However, in most emergency situations, such as epilepsy or allergic shock, it
is preferable to administer the drug by intramuscular injection, potentially
through clothing. ZENEO® has recently demonstrated its ability to perform
such injections (see our press release of 2 November 2022 announcing the
positive readout of the ZENEO® Midazolam clinical study, developed for
epileptic seizures). This makes Crossject the only company worldwide to offer
a means of intramuscular injection (on bare skin or through clothing) in a
fraction of a second.
Crossject, developer of therapeutic solutions
Crossject is a developer of therapeutic solutions, working both on the ZENEO®
medical device and on the combination of ZENEO® with a drug adapted to each
therapeutic indication.
As a company with ISO 13485 certification for the design, development,
production and manufacture of a sterile single-use auto-injector (see our
press release of 15 August 2022) and as a pharmaceutical company (see our
press release of 16 November 2021), Crossject is ideally positioned to develop
innovative solutions.
Marketing authorisation applications for the three priority indications
(epilepsy, acute adrenal insufficiency, allergic shock) are scheduled to be
submitted in 2024. However, the goal is still to file an Emergency Use
Authorization application under the BARDA contract in 2023 (see below).
It is important to note that Crossject used advanced reliability
quantification techniques to develop ZENEO® in order to meet the FDA’s very
demanding standards (at least 99.999% compliant injections, which is
equivalent to less than ten mechanical failures per million injections).
Crossject, manufacturer
Crossject has a three-stage industrial chain for the manufacture of its
medical devices. Upstream, the company subcontracts the manufacture of
components to partners with the necessary expertise in plastic or metal
injection, glass forming, elastomer moulding, etc. Crossject generally owns
the specific tools, which are integrated into the partner’s industrial
facilities.
Downstream, Crossject sources its active ingredients from specialised chemical
manufacturers and delivers them to a manufacturer specialised in the mixing
and filling of sterile injectable liquid products (fill/finish). Crossject
also supplies the manufacturer with a ready-to-fill kit consisting of two
sub-assemblies: a sterile pharmaceutical sub-assembly, intended to receive the
drug, prepared and shipped from Crossject’s Dijon site, and an actuator (the
injector’s mechanical part), assembled and shipped from Crossject’s Gray
site.
Crossject already has highly efficient industrial facilities; each piece of
equipment has its own capacity, so the maximum capacity of the whole is
determined by the slowest workstation; Crossject accordingly has production
capacity of more than 500,000 ready-to-fill kits per year – capacity that is
about to increase with the ongoing installation of new equipment recently
delivered with the support of France Relance (press release of 10 March 2021).
Crossject’s medium-term strategy is to grow its industrial capacity by
removing bottlenecks as business needs change. The renovation of a 1000 sq.m.
building on the Gray site (delivery scheduled before this summer) will allow
Crossject to lift its capacity to more than 6 million units per year.
Marketing
Crossject initially chose to entrust the distribution of its products to
pharmaceutical companies already established in the relevant geographies and
therapeutic indications.
The priority geographies are North America and Western Europe.
Of the seven therapeutic indications in its portfolio, two are already covered
by licensing agreements, namely acute adrenal insufficiency for North America
(press release of 16 June 2021) and epilepsy for Germany (press release of 18
June 2019), for which several milestones have been successfully achieved.
A new indication could also be developed in partnership with an American
laboratory (press release of 15 September 2022).
Crossject’s epilepsy product is also the subject of a contract with BARDA
(the US government agency that supports the research, development and
manufacture of medical products for public health emergencies) (press release
of 18 June 2022, contract no. 75A50122C00031). The total value of the contract
– if all options are exercised – is $155 million and includes advanced
regulatory development in the United States and the supply of products to the
US Strategic National Stockpile, upon approval from the US Food and Drug
Administration (FDA). The aim is to start deliveries by the end of 2023,
subject to obtaining Emergency Use Authorisation (EUA) from the Food Drug
Administration (FDA).
Crossject, a committed company
In recent years, Crossject has demonstrated its commitment on CSR questions,
with a gender equality index reading above 90 for two consecutive years and a
significant increase in its GAIA index from 15 to 60 in just three years. The
company has also received a Responsible Care® award, demonstrating its
commitment to transforming itself into a major player in the field of
life-saving emergency medicines.
Financial information as of 31 December 2022
In line with the business plan, the strengthening of our financial base to
support the very substantial acceleration of our development was a real
success in 2022. The €22 million financial reinforcement came from several
sources;
* BARDA invoicing: $1.8 million invoiced in 2022
* Free allocation of equity warrants to all shareholders: €2.8 million
* Capital increase with preferential subscription rights: €4.09 million
* Exercise of warrants: €0.2 million
* New borrowings: at the end of the year we completed a major non-dilutive
financial transaction of €14 million, with €4 million in loans granted in
2022. The transaction includes various loans granted by long-standing banks
(Caisse d’Epargne and BNP), Société Générale and BPI, with amortisation
periods ranging from 5 to 10 years, and nearly 85% of the total available
immediately.
All OC1223 convertible bonds were converted during the year and 95.7% of the
OC1224 convertible bonds were converted during the year, the balance being
converted this day.
In the year ended 31 December 2022, we recorded a very substantial increase in
operating income to €9.7 million, an increase of 43%.
It includes €0.95 million in revenue relating to milestones achieved during
the year.
€ thousand, as of 31 December 2022 2021
Operating income 9,718 6,772
Operating expenses -23,005 -18,594
Purchases of raw materials and supplies -498 -954
Other purchases and external expenses -8,116 -5,901
Personnel expenses -7,424 -6,183
Taxes and duties -176 -202
Depreciation, amortisation and provisions -6,358 -5,013
Other expenses -433 -342
Operating profit/(loss) -13,288 -11,823
Financial income/(expense) -319 -774
Exceptional income/(expense) 228 81
Corporate tax 2,222 1,818
Net profit/(loss) -11,157 -10,698
The financial statements for the six months to 31 December 2022 were approved by the members of the Management Board on 20 March 2023 and presented at the Supervisory Board meeting of 20 March 2023. They have been audited.
In addition, capitalised production increased by 13% to €6.1 million as a
result of ongoing research and development activities.
During the year, Crossject maintained its focus on cost control. Operating
expenses increased by just 24%, a very moderate rise in relation to that of
operating income.
Other purchases and external expenses amounted to €8.1 million, compared
with €5.9 million in 2021, attributable notably to the progress of
production work linked to the BARDA contract, the completion of various
clinical studies and batches on several drugs in the portfolio and the costs
inherent to the industrial ramp-up in the broad sense.
At the end of 2022, Crossject had approximately 100 employees, a slight
increase compared with the end of 2021. Personnel expenses amounted to €7.4
million in 2022, compared with €6.2 million in 2021, taking into account
recruitments in 2022 aimed at obtaining more qualified skills better suited to
our stage of development.
The overall operating loss was €13.3 million, compared with a loss of
€11.8 million in 2021.
The Group recorded net financial expense of 0.3 million for 2022, compared
with an expense of €0.9 million for 2021.
After taking into account exceptional income of €0.2 million and a Research
Tax Credit of €2.2 million, an increase of €0.4 million on 2021, the net
loss for 2022 was €11.2 million.
As of 31 December 2022, Crossject had cash of €8 million (€10 million at
the end of 2021), plus €6.2 million in non-dilutive financing announced at
the end of the year and €3.8 million from the same plan, yet to be received,
of which €2.0 million is conditional on obtaining Emergency Use
Authorisation (EUA) from the Food Drug Administration (FDA).
In view of current contracts (and in particular monthly invoicing to BARDA)
and the very clear visibility Crossject has acquired in recent months, the
company is confident in its ability to find the necessary financing to
continue its development.
Contacts:
Crossject Patrick Alexandre info@crossject.com Investor relations AELIUM Jérôme Gacoin +33 (0) 1 75 77 54 67 crossject@aelium.fr
Press relations Buzz & Compagnie Mélanie Voisard +33 (0)6 12 52 53 15 melanie.voisard@buzzetcompagnie.com Christelle Distinguin +33 (0)6 09 96 51 70 christelle.distinguin@buzzetcompagnie.com
About CROSSJECT • www.crossject.com
Crossject (ISIN: FR0011716265; Ticker: ALCJ; LEI: 969500W1VTFNL2D85A65) is
developing and is soon to market a portfolio of drugs dedicated to emergency
situations: epilepsy, overdose, allergic shock, severe migraine and asthma
attack. Thanks to its patented needle-free self-injection system, Crossject
aims to become the world leader in self-administered emergency drugs. The
company has been listed on the Euronext Growth market in Paris since 2014, and
benefits from Bpifrance funding.
APPENDICES
Income statement (in €k) 44561 44561 Change
Revenue 954 912 42
Stored production 348 170 178
Capitalised production 6 5,383 -5,377
Subsidies 5 185 -180
Reversals of provisions and transfers of expenses 445 98 347
Other income 1,861 24 1,837
Operating income 3,619 6,772 -3,153
Purchases of raw materials and other supplies 1,002 1,143 -141
Change in inventory (raw materials and other supplies) -505 -189 -316
Other purchases and external expenses 8,115 5,901 2,214
Taxes and duties 177 202 -25
Personnel expenses 7,425 6,183 1,242
Depreciation, amortisation 5,263 4,490 773
Other provisions 1,095 523 572
Other expenses 433 342 91
Operating expenses 23,005 18,595 4,410
Operating profit/( loss ) -19 , 386 -11 , 823 -7 , 563
Financial income /( expense ) -319 -882 563
Exceptional income /( expense ) 228 81 147
Research Tax Credit 2,222 1,818 404
NET PROFIT/(LOSS) -17 , 255 -10 , 806 -6 , 449
BALANCE SHEET – ASSETS (in €k) 31/12/2022 31/12/2021 CHANGE
FIXED ASSETS
R&D 10,691 9123 1,568
Patents and trademarks 6 -6
Other intangible assets 11 -11
Land 89 89 0
Property, plant and equipment 5,085 4,631 454
Assets under construction 2,492 2,426 66
Financial assets 672 516 156
TOTAL FIXED ASSETS 19 , 029 16 , 802 2 , 227
CURRENT ASSETS
Raw materials, other supplies 1,416 863 553
Work in process 588 503 85
Advances and prepayments received on orders in progress 345 294 51
Trade and related receivables 726 44 682
State and other receivables 2,450 1,931 519
Marketable securities 154 -154
Available cash 7,769 9,830 -2,061
Prepaid/deferred expenses 536 923 -387
TOTAL CURRENT ASSETS 13 , 830 14 , 542 -712
TOTAL ASSETS 32 , 859 31 , 344 1 , 515
BALANCE SHEET – LIABILITIES (in €k) 31/12/2022 31/12/2021 CHANGE
SHAREHOLDERS’ EQUITY
Capital 3652 2604 1048
Share premium 18312 6036 12276
Regulated reserve 0 0 0
Retained earnings -8786 -3980 -4806
Profit/(loss) for the year -11157 -10698 -459
Investment subsidies 665 665 0
TOTAL SHAREHOLDERS’ EQUITY 2686 -5373 8059
Conditional advances 7476 7476 0
Provisions for contingencies and charges 1420 810 610
BORROWINGS AND DEBT
Bonds 355 12587 -12232
Loans 11048 7946 3102
Miscellaneous 2722 2794 -72
Debts – Trade payables 3523 1961 1562
Total tax and social security liabilities 1833 1183 650
Debts on fixed assets 1764 2247 -483
Deferred income 32 0 32
TOTAL DEBT 21277 28718 -7441
TOTAL EQUITY AND LIABILITIES 32859 31631 1228
HEADINGS
31/12/2022 31/12/2021
Net profit/( loss ) - 11 , 157 . 00 - 10 , 806 . 00
Depreciation, amortisation and provisions 5,705.00 5,078.00
Capital gains on disposal, net of tax 1,00
Other income and expenses calculated - 28.39 - 28.39
Cancellation of exceptional income on cancellation of debt
Cash flow from operations -5,479.39 - 5 756,39
Change in working capital requirements 399.03 - 327,32
(1) Net cash generated by (used in) operating activities -5 , 080 . 36 - 6 , 083 . 71
Acquisition of fixed assets -6,778.69 - 6,732.62
(2) Net cash generated by (used in) investing activities -6 , 778 . 69 - 6 , 732,62
Capital increase 4,088.86
Exercise of warrants 3,003.17
Bonds - 13 066.09
Loans 4,000,00 - 6,123.84
Repayment of borrowings - 969.15 7,826.09
Subsidies - 716,13
Debts on fixed assets - 483.21 - 962,18
Repayable advances -
(3) Net cash generated by (used in) financing activities 9 , 639 . 67 14 , 522 . 30
Change in cash and cash equivalents ( 1)+( 2)+(3) -2 , 219 . 38 1 , 705 . 97
Opening cash position 9 , 983 . 07 8 , 277 . 11
Closing cash position 7 , 769 . 58 9 , 983 . 07
Attachment
* Crossject_CP_RA2022 VD ENG
(https://ml-eu.globenewswire.com/Resource/Download/95f836fa-59f8-410f-bb0c-21a27cc38e48)
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