- Second quarter 2024 total
revenues increased by 35% to US$74.1 million, compared to the
second quarter 2023, driven by strong RUCONEST® and Joenja® revenue
growth
- RUCONEST® second quarter
revenue increased by 23% to US$63.0 million, compared to the second
quarter 2023
- Joenja® (leniolisib) second
quarter revenue increased by 16% to US$11.1 million, compared to
the first quarter 2024
- First half total revenues
increased by 33% to US$129.7 million, compared to the first half
2023
- On track for 2024 total
revenue guidance of US$280 million - US$295 million (14 - 20%
growth)
- Overall cash and marketable
securities declined to US$161.8 million at the end of the second
quarter 2024 from US$203.5 million at the end of the first quarter
2024, primarily due to convertible bond refinancing
- Pharming to host a
conference call today at 13:30 CEST (7:30 am EDT)
Leiden, the Netherlands, August 1,
2024: Pharming Group N.V. (“Pharming” or “the Company”)
(Euronext Amsterdam: PHARM/Nasdaq: PHAR) presents its preliminary
(unaudited) financial report for the second quarter and first half
year ended June 30, 2024.
Chief Executive Officer, Sijmen de
Vries, commented:“Pharming has delivered another strong
quarter of revenue growth, increasing quarterly revenues by 35% to
US$74.1 million. We are firmly on track to meet our 2024 total
revenue guidance of US$280 million - US$295 million. We also
narrowed our operating loss on a like for like basis compared to
the second quarter of the prior year.
RUCONEST® performed particularly strongly, with
second quarter revenue increasing by 23% compared to 2Q 2023, and
we have seen continued strength in underlying demand as well as a
growing number of new patient enrollments.
A year after the U.S. launch of Joenja®, the
number of new patients on therapy is increasing quarter-on-quarter,
with an increase of eight patients this quarter compared to two in
the first quarter, and we are seeing high adherence rates for
patients on paid therapy. Our patient finding and family testing
efforts are continuing to help get new patients diagnosed, and we
have seen positive early results on Variant of Uncertain
Significance (VUS) reclassifications which suggest a significant
increase in the identified APDS patient population in the US. We
continue to work with regulatory authorities worldwide to make
Joenja® (leniolisib) available to as many patients as possible, and
expect a decision on the Marketing Authorisation Application from
the UK MHRA in the fourth quarter. While we were disappointed by
the delay to the European marketing authorisation, we are
continuing to work closely with the EMA and CHMP, and are pleased
that the CHMP determined the clinical benefit of leniolisib to be
positive.
As we work to expand the leniolisib market
opportunity to other primary immunodeficiency (PID) disorders, we
will initiate the Phase II proof-of-concept clinical trial in PIDs
with immune dysregulation linked to PI3Kẟ signaling in the third
quarter. We are also continuing to prepare a clinical development
plan for a third PID indication.
We expect this positive momentum to continue for
the rest of the year, and I would like to thank all our employees
for their significant achievements in the first half.”
Second quarter and first half highlights
Commercialized assetsRUCONEST® marketed
for the treatment of acute HAE attacks
RUCONEST® continued to perform well in the
second quarter of 2024, with revenue of US$63.0 million, a 23%
increase compared to the second quarter of 2023. Revenue for the
first half of 2024 was US$109.0 million, a 16% increase compared to
the same period in 2023.
The U.S. market contributed 96% of second
quarter revenues, while the EU and Rest of World contributed
4%.
In the U.S. market, we saw continued strength in
the second quarter in underlying in-market demand for RUCONEST®,
including over 100 new patient enrollments. We achieved strong
overall performance in the second quarter in other leading key
revenue indicators including new physicians prescribing RUCONEST®
and the total number of patients on therapy. Increasing enrollments
helped to drive a sharp increase in unique patient shipments in the
second quarter.
Joenja® (leniolisib) marketed in the U.S. - the first
and only approved disease modifying treatment for APDS
Joenja® revenues increased to US$11.1 million in
the second quarter of 2024, a 16% increase compared to the first
quarter of 2024 and a 192% increase compared to the second quarter
of 2023. This increase was mostly driven by higher volume from the
continued increase in patients on paid therapy in the U.S., higher
adherence rates for patients on paid therapy, and revenues from EU
and Rest of World. Revenue for the first half of 2024 was US$20.7
million, compared to US$3.8 million for the same period in
2023.
As of June 30, 2024, we have 91 patients on paid
therapy in the U.S. and an additional two patients enrolled and
pending authorization, representing an increase of eight patients
on paid therapy during the second quarter as compared to an
increase of two patients during the first quarter.
EU and Rest of World revenues are from product
provided on a named patient basis. Pharming has named patient and
other funded early access programs in certain countries where
leniolisib is not commercially available: physicians can request
leniolisib on behalf of individual patients living with APDS who
meet the eligibility criteria and receive local health authority
approval.
APDS patient finding
As of June 30, 2024, Pharming had identified
over 870 diagnosed APDS patients of all ages in global markets,
including over 230 patients in the U.S. Of the identified patients
in the U.S., over 150 patients are 12 years of age or older and
eligible for treatment with Joenja®. Over 780 of these globally
identified patients are in target markets for Pharming in the U.S.,
Europe, the U.K., Japan, Asia Pacific, Middle East, Latin America
and Canada, with estimated total prevalence of approximately 2,400
APDS patients.
Pharming continues to advance several
initiatives to diagnose additional APDS patients, including a
sponsored genetic testing program in the U.S. and Canada,
partnerships with several genetic testing companies who undertake
their own testing efforts, and family testing programs.
Pharming’s Variant of Uncertain Significance
(VUS) resolution efforts are ongoing, including validation studies
with various laboratories to confirm which VUSs can be classified
as APDS. As results become available, patients with validated
variants could be diagnosed with APDS and, therefore, potentially
be eligible for Joenja® treatment. Completion of the in vitro high
throughput screening study is expected during the fourth quarter of
2024.
In the U.S. market, the number of diagnosed APDS
patients increased by 10 during the second quarter 2024.
APDS patient finding - VUS resolution
Pharming has identified approximately 1,200
patients in the U.S. with a VUS in the PIK3CD or PIK3R1 genes and
is performing validation studies with various laboratories to
confirm which of these variants are pathogenic for APDS. Patients
with disease-associated variants would receive a molecular
diagnosis of APDS and, therefore, potentially be eligible for
Joenja® treatment. Based on data from Pharming’s navigateAPDS
sponsored genetic testing program, PIK3CD and PIK3R1 VUSs are found
at four times the frequency of pathogenic / likely pathogenic
variants classified as APDS.
A literature review, which includes more than
1.5 million patients, showed that 20% of reclassified VUSs are
upgraded to likely pathogenic / pathogenic. Pharming also recently
completed a pilot study with 25 patients with a VUS who then
underwent further testing of the PI3K-AkT-mTOR pathway, and results
were consistent, with VUS reclassifications to APDS for five of
these patients.
Together, these data suggest that there could be
a significant increase in the number of APDS patients in the US
once those patients with a VUS are reclassified.
Pharming is expanding the pilot study to allow
additional patients with a VUS to be tested, and the data generated
are being shared with central databases (ClinVar) and genetic
testing labs so that the same variants found in the future may be
classified correctly without need for further testing.
Additionally, Pharming is working with
researchers to be able to evaluate large numbers of VUSs without
the need for additional patient testing. VUS resolution via high
throughput screening methods is a common approach and is accepted
as strong evidence by various expert organizations including the
American College of Medical Genetics (ACMG) and ClinGen (a National
Institutes of Health-funded resource). An initial evaluation of
this approach has recently been published and confirmed the ability
to differentiate benign vs. pathogenic variants, and identified new
pathogenic variants. Full results from this study are on track to
be available by the end of 2024.
Joenja® (leniolisib) strategic highlights - regulatory,
clinical and commercial strategy updates
Leniolisib for APDS
Pharming made continued progress in the second
quarter of 2024 on leniolisib regulatory filings for APDS patients
12 years of age and older in key global markets. In addition,
Pharming progressed ongoing clinical trials to support regulatory
filings for approval in Japan and pediatric label expansion.
Pharming’s strategy is to expand the commercial
availability of leniolisib for APDS patients to key markets in
Europe, U.K., Japan, Asia Pacific, Middle East, Latin America and
Canada. Pharming intends to market leniolisib directly in most of
these markets following regulatory approval.
In total, there are currently 150 patients in a
leniolisib Expanded Access Program (compassionate use), an ongoing
clinical study, or a named patient program.
European Economic Area (EEA)
As announced on May 30, 2024, the European
Medicines Agency’s (EMA) Committee for Human Medicinal Products
(CHMP) issued an updated List of Outstanding Issues (LoOI)
regarding the leniolisib Marketing Authorisation Application (MAA).
The LoOI affirmed the positive clinical benefit and safety of
leniolisib, in agreement with the assessment by the Ad Hoc Expert
Group (AEG), and included one remaining chemistry, manufacturing
and controls (CMC) request. The CMC request relates to the
definition of regulatory starting materials used in the
manufacturing process for leniolisib. The CHMP requested that this
work be completed pre-approval and granted Pharming an extension to
January 2026 to submit a response. Pharming plans to complete the
manufacturing activities requested by the CHMP and submit a
response prior to this deadline.
United Kingdom
On March 12, 2024, Pharming submitted an MAA for
leniolisib with the U.K. Medicines and Healthcare products
Regulatory Agency (MHRA), through the International Recognition
Procedure (IRP) on the basis of the U.S. FDA approval. The MAA for
leniolisib was validated on April 17, 2024. Pharming received the
MHRA Day 70 Request for Further Information on July 3, 2024. There
were no major objections. Upon Pharming’s satisfactory response to
MHRA requests, it is expected that the MHRA will issue its decision
in the fourth quarter of 2024.
Additional markets - Canada
Pharming filed a regulatory submission in Canada
for leniolisib for APDS in the third quarter of 2023. Pharming
recently submitted a response to a Health Canada Notice of
Deficiency in July 2024. Pharming is awaiting feedback on next
steps but no longer anticipates regulatory approval in 2024.
Leniolisib for additional indications (PI3Kδ platform) -
Primary immunodeficiencies (PIDs) beyond APDS
Pharming is planning a Phase II, proof of
concept, clinical trial in targeted PID genetic disorders with
immune dysregulation linked to PI3Kẟ signaling in lymphocytes, with
similar clinical phenotypes to APDS. These PID disorders include
ALPS-FAS, CTLA4 haploinsufficiency and PTEN deficiency. The
epidemiology of these targeted PID genetic disorders suggests a
prevalence of approximately five patients per million.
The Phase II clinical trial is a single arm,
open-label, dose range-finding study to be conducted in
approximately 12 patients. The objectives for the trial will be to
assess safety and tolerability, pharmacokinetics, pharmacodynamics,
and explore clinical efficacy of leniolisib in the targeted PID
population. The trial has been designed to inform a subsequent
Phase III program. Pharming is in the final stages of preparation
for the start of the trial, which it expects to initiate
shortly.
Pharming has also prioritized development of
leniolisib for an additional PID indication. Pharming will provide
further updates and details on our plans after obtaining regulatory
feedback on the proposed clinical development plan.
Financial Summary
Consolidated Statement of Income |
2Q 2024 |
2Q 2023 |
1H 2024 |
1H 2023 |
Amounts in US$m except per share data |
|
|
|
|
Total Revenues |
74.1 |
54.9 |
129.7 |
97.4 |
Cost of sales |
(8.0) |
(5.7) |
(16.4) |
(9.8) |
Gross profit |
66.1 |
49.2 |
113.3 |
87.6 |
Other income |
0.9 |
21.9 |
1.3 |
22.5 |
Research and development |
(21.6) |
(20.9) |
(40.1) |
(36.5) |
General and administrative |
(15.6) |
(11.0) |
(30.7) |
(21.0) |
Marketing and sales |
(32.9) |
(33.9) |
(63.2) |
(61.0) |
Other Operating Costs |
(70.1) |
(65.8) |
(134.0) |
(118.5) |
Operating profit (loss) |
(3.1) |
5.3 |
(19.4) |
(8.4) |
Fair value gain (loss) on revaluation |
5.1 |
— |
5.1 |
— |
Other finance income |
1.2 |
0.7 |
2.9 |
0.8 |
Other finance expenses |
(2.9) |
(2.5) |
(4.5) |
(5.2) |
Share of net profits in associates using the equity method |
(0.4) |
(0.1) |
(0.8) |
(0.5) |
Profit (loss) before tax |
(0.1) |
3.4 |
(16.7) |
(13.3) |
Income tax credit (expense) |
(1.1) |
(2.1) |
3.0 |
2.4 |
Profit (loss) for the period |
(1.2) |
1.3 |
(13.7) |
(10.9) |
Share Information |
|
|
|
|
Basic earnings per share (US$) |
(0.002) |
0.002 |
(0.020) |
(0.017) |
Diluted earnings per share (US$) |
(0.002) |
0.002 |
(0.020) |
(0.017) |
Segment information - Revenues |
2Q 2024 |
2Q 2023 |
1H 2024 |
1H 2023 |
Amounts in US$m |
|
|
|
|
Revenue - RUCONEST® (US) |
61.6 |
50.2 |
106.4 |
90.9 |
Revenue - RUCONEST® (EU and RoW) |
1.4 |
0.9 |
2.6 |
2.7 |
Total Revenues - RUCONEST® |
63.0 |
51.1 |
109.0 |
93.6 |
Revenue - Joenja® (US) |
10.2 |
3.8 |
18.7 |
3.8 |
Revenue - Joenja® (EU and RoW) |
0.9 |
— |
2.0 |
— |
Total Revenues - Joenja® |
11.1 |
3.8 |
20.7 |
3.8 |
|
|
|
|
|
Total Revenues - US |
71.8 |
54.0 |
125.1 |
94.7 |
Total Revenues - EU and RoW |
2.3 |
0.9 |
4.6 |
2.7 |
|
|
|
|
|
Total Revenues |
74.1 |
54.9 |
129.7 |
97.4 |
Consolidated Balance Sheet |
June 30, 2024 |
December 31, 2023 |
Amounts in US$m |
|
|
Cash and cash equivalents, restricted cash and marketable
securities |
161.8 |
215.0 |
Current assets |
270.6 |
316.3 |
Total assets |
415.9 |
462.9 |
Current liabilities |
79.9 |
78.0 |
Equity |
220.9 |
218.8 |
Financial highlightsSecond quarter
2024
For the second quarter of 2024, revenues
increased by US$19.2 million, or 35%, to US$74.1 million, compared
to US$54.9 million in the second quarter of 2023. RUCONEST®
revenues amounted to US$63.0 million, a 23% increase compared to
the second quarter of 2023. The volume increase in the U.S., and a
U.S. price increase in line with CPI, were the primary factors
behind this increase in RUCONEST® revenues. Joenja® revenues
amounted to US$11.1 million in the second quarter of 2024, a 16%
increase compared to the first quarter of 2024 and a 192% increase
compared to the second quarter of 2023. This increase in Joenja®
revenues was primarily driven by an increase in volume.
Gross profit increased by US$16.9 million or 34%
to US$66.1 million (2Q 2023: US$49.2 million), mainly due to the
increase in revenues.
Other income decreased to US$0.9 million
compared to US$21.9 million in the second quarter of 2023. Other
income in the second quarter of 2023 was supported by the sale of
the Rare Pediatric Disease Priority Review Voucher (PRV) to
Novartis for a pre-agreed, one-time payment of US$21.1 million.
The operating loss amounted to US$3.1 million
compared to an operating profit of US$5.3 million in the second
quarter of 2023. In addition to the support in gross profit and
other income mentioned above, this change was mainly due to an
expected increase in operating expenses from US$65.8 million in the
second quarter of 2023 to US$70.1 million in the second quarter of
this year. The second quarter 2023 operating expenses included
milestone payments for Joenja® amounting to US$10.5 million. The
increase in operating expenses was caused by a combination of
continuing investments in Joenja® in the U.S., launch preparation
for leniolisib outside of the U.S., increasing R&D investments
to expand the leniolisib franchise and increased payroll expenses
due to business growth. Excluding the proceeds from the PRV sale
and the milestone payment expenses for Joenja® in the second
quarter of 2023, the operating loss decreased from US$5.3 million
to US$3.1 million in the second quarter of the current year.
The net finance result amounted to a gain of
US$3.4 million compared to a loss of US$1.8 million in the second
quarter of 2023. This was primarily driven by a fair value gain of
US$5.1 million upon the reclassification of the convertible
bond-related derivative to equity. This fair value gain was a
result of the decrease in value of the option component classified
as a derivative from issuance until the physical settlement date of
the newly issued convertible bond. For more information on the
matter, reference is made to Note 18. Convertible bonds of the
Notes to the condensed consolidated interim financial statements of
this press release. This fair value gain is tax exempt, resulting
in a favorable income tax credit.
The Company had a net loss of US$1.2 million,
compared to a net profit of US$1.3 million in the second quarter of
2023. In addition to the support in other income from the PRV sale
and the milestone payments for Joenja® in the second quarter of
2023, the change was mainly due to an increase in operating
expenses, offset by an increase in revenues and the fair value gain
upon the reclassification of the convertible bond-related
derivative to equity.
Cash and cash equivalents, including restricted
cash and marketable securities, decreased from US$203.5 million at
the end of first quarter of 2024 to US$161.8 million at the end of
the second quarter of 2024. This decrease was primarily driven by
the repurchase of the outstanding convertible bonds amounting to
US$134.9 million, offset by net proceeds of US$104.8 million for
newly issued convertible bonds. In addition, the decrease was
accompanied by a US$12.4 million increase in receivables in the
second quarter of 2024, resulting from higher revenues.
First half year 2024
Total revenues increased 33% during the first
half of 2024 to US$129.7 million, versus US$97.4 million during the
first half of 2023. For the first half of 2024, total RUCONEST®
revenues were 16% higher at US$109.0 million, compared to revenues
of US$93.6 million for the first half of 2023. Joenja® revenues
amounted to US$20.7 million in the first half of 2024, a 44%
increase compared to the second half of 2023. This increase in
Joenja® revenues was primarily driven by an increase in volume.
Gross profit increased by US$25.7 million or 29%
to US$113.3 million (1H 2023: US$87.6 million), mainly due to the
increase in revenues.
Further details on revenue and gross profit
segmentation is provided in Note 7. Segment information in the
Notes to the condensed consolidated interim financial statements of
this press release.
Other income decreased to US$1.3 million
compared to US$22.5 million in the first half of 2023. Other income
in the first half of 2023 was supported by the sale of the Rare
Pediatric Disease Priority Review Voucher (PRV) to Novartis for a
pre-agreed, one-time payment of US$21.1 million.
The operating loss amounted to US$19.4 million
compared to an operating loss of US$8.4 million in the first half
of 2023. In addition to the support in gross profit and other
income mentioned above, this change was mainly due to an expected
increase in operating expenses from US$118.5 million in the first
half of 2023 to US$134.0 million in the first half of this year.
The second quarter 2023 operating expenses included milestone
payments for Joenja® amounting to US$10.5 million. The increase in
operating expenses was caused by a combination of continuing
investments in Joenja® in the U.S., launch preparation for
leniolisib outside of the U.S., increasing R&D investments to
expand the leniolisib franchise and increased payroll expenses due
to business growth. Excluding the proceeds from the PRV sale and
the milestone payment expenses for Joenja® in the first half of
2023, the operating loss increased from US$19.0 million to US$19.4
million in the first half of the current year.
The net finance result amounted to a gain of
US$3.6 million compared to a loss of US$4.5 million in the first
half of 2023. This was primarily driven by a fair value gain of
US$5.1 million upon the reclassification of the convertible
bond-related derivative to equity. This fair value gain was a
result of the decrease in value of the option component classified
as a derivative from issuance until the physical settlement date of
the newly issued convertible bond. For more information on the
matter, reference is made to Note 18. Convertible bonds of the
Notes to the condensed consolidated interim financial statements of
this press release. In addition, EUR/USD exchange rate developments
led to a foreign currency gain of US$0.2 million compared to a loss
of US$2.3 million in the first half of 2023.
The Company had a net loss of US$13.7 million,
compared to a net loss of US$10.9 million in the first half of
2023. In addition to the support in other income from the PRV and
the milestone payments for Joenja® in the first half of 2023, the
change was mainly due to an increase in revenues, favorable EUR/USD
exchange rate developments and the fair value gain upon the
reclassification of the convertible bond-related derivative to
equity, offset by an increase in operating expenses.
Cash and cash equivalents, including restricted
cash and marketable securities, decreased from US$215.0 million at
the end of 2023 to US$161.8 million at the end of the first half of
2024. This decrease was primarily driven by the repurchase of the
outstanding convertible bonds amounting to US$134.9 million, offset
by net proceeds of US$104.8 million for newly issued convertible
bonds, and negative cash flows from operations amounting to US$20.9
million.
On 5 October 2023, Orchard Therapeutics Plc.
(Orchard) announced it had entered into a definitive agreement with
Japanese company Kyowa Kirin Co. LTD for the acquisition of
Orchard. During the first half of 2024, Pharming received
US$2.0 million in cash for its shares held in Orchard.
Pharming has terminated the research collaboration & licensing
agreement with Orchard Therapeutics and discontinued the OTL-105
program.
Outlook/SummaryFor 2024, the Company
anticipates:
- Total revenues between US$280
million and US$295 million (14% to 20% growth), with quarterly
fluctuations expected.
- Continued progress finding
additional APDS patients in the U.S., supported by family testing
and VUS validation efforts, and subsequently converting patients to
paid Joenja® (leniolisib) therapy.
- Increasing ex-U.S. revenues
leniolisib - from commercial availability or through our Named
Patient Program and other funded early access programs in key
global markets.
- Completion of leniolisib clinical
trials to support regulatory filings for approval in Japan and
pediatric label expansion in key global markets.
- Progress towards regulatory
approvals for leniolisib in the EEA, the U.K., Canada and
Australia.
- Initiate and advance a Phase II
clinical trial for leniolisib in PIDs with immune dysregulation
linked to PI3Kδ signaling to significantly expand the long-term
commercial potential of leniolisib.
- Continued operating cost
investments to accelerate future revenue growth. Our current cash
on hand and the continued cash flow from product revenues are
expected to be sufficient to fund these investments. No material
cash burn is expected prior to the impact of potential acquisition
or in-licensing transactions.
- Continued focus on potential
acquisitions and in-licensing of clinical stage opportunities in
rare diseases. Financing, if required, would come via a combination
of our strong balance sheet and access to capital markets.
No further specific financial guidance for 2024
is provided.
Additional
informationPresentation
The conference call presentation is available on
the Pharming.com website from 07:30 CEST today.
Conference Call
The conference call will begin at 13:30
CEST/07:30 EDT on Thursday, August 1. A transcript will be made
available on the Pharming.com website in the days following the
call.
Please note, the Company will only take
questions from dial-in attendees.
Webcast Link:
https://edge.media-server.com/mmc/p/awvi6h6a
Conference call dial-in details:
https://register.vevent.com/register/BI92328f52b76d43d394cacc1c2ba94ac4
Additional information on how to register for
the conference call/webcast can be found on thePharming.com
website.
Financial Calendar 2024
3Q 2024 financial
results October
24
For further public information, contact:
Pharming Group N.V., Leiden, the
NetherlandsMichael Levitan, VP Investor Relations & Corporate
CommunicationsT: +1 (908) 705 1696E: investor@pharming.com
FTI Consulting, London, UKVictoria Foster
Mitchell/Alex ShawT: +44 203 727 1000
LifeSpring Life Sciences Communication,
Amsterdam, the NetherlandsLeon MelensT: +31 6 53 81 64 27E:
pharming@lifespring.nl
About Pharming Group N.V.
Pharming Group N.V. (EURONEXT Amsterdam:
PHARM/Nasdaq: PHAR) is a global biopharmaceutical company dedicated
to transforming the lives of patients with rare, debilitating, and
life-threatening diseases. Pharming is commercializing and
developing an innovative portfolio of protein replacement therapies
and precision medicines, including small molecules and biologics.
Pharming is headquartered in Leiden, the Netherlands, and has
employees around the globe who serve patients in over 30 markets in
North America, Europe, the Middle East, Africa, and
Asia-Pacific.
For more information, visit
www.pharming.com and find us on LinkedIn.
Auditor’s involvement
The Condensed Consolidated Interim Financial
Statements have not been audited by the Company’s statutory
auditor.
Responsibility Statement
The Board of Directors of the Company (the
“Board”) hereby declares that to the best of its knowledge, the
condensed consolidated interim financial statements, which have
been prepared in accordance with IAS 34 (interim financial
reporting), give a true and fair view of the assets, liabilities,
financial position and profit or loss of the Company, and this
interim Board report includes a fair review of the information
required pursuant to section 5:25d(8) and (9) of the Dutch
Financial Supervision Act (Wet op het financieel toezicht).
Leiden, August 1, 2024Sijmen de Vries, Executive
Director and Chief Executive OfficerRichard Peters, Non-Executive
Director and Chairman of the Board of DirectorsDeborah Jorn,
Non-Executive DirectorSteven Baert, Non-Executive DirectorLeonard
Kruimer, Non-Executive DirectorJabine van der Meijs, Non-Executive
DirectorBarbara Yanni, Non-Executive DirectorMark Pykett,
Non-Executive Director
Forward-looking Statements
This press release may contain forward-looking
statements. Forward-looking statements are statements of future
expectations that are based on management’s current expectations
and assumptions and involve known and unknown risks and
uncertainties that could cause actual results, performance, or
events to differ materially from those expressed or implied in
these statements. These forward-looking statements are identified
by their use of terms and phrases such as “aim”, “ambition”,
‘‘anticipate’’, ‘‘believe’’, ‘‘could’’, ‘‘estimate’’, ‘‘expect’’,
‘‘goals’’, ‘‘intend’’, ‘‘may’’, “milestones”, ‘‘objectives’’,
‘‘outlook’’, ‘‘plan’’, ‘‘probably’’, ‘‘project’’, ‘‘risks’’,
“schedule”, ‘‘seek’’, ‘‘should’’, ‘‘target’’, ‘‘will’’ and similar
terms and phrases. Examples of forward-looking statements may
include statements with respect to timing and progress of
Pharming's preclinical studies and clinical trials of its product
candidates, Pharming's clinical and commercial prospects, and
Pharming's expectations regarding its projected working capital
requirements and cash resources, which statements are subject to a
number of risks, uncertainties and assumptions, including, but not
limited to the scope, progress and expansion of Pharming's clinical
trials and ramifications for the cost thereof; and clinical,
scientific, regulatory, commercial, competitive and technical
developments. In light of these risks and uncertainties, and other
risks and uncertainties that are described in Pharming's 2023
Annual Report and the Annual Report on Form 20-F for the year ended
December 31, 2023, filed with the U.S. Securities and Exchange
Commission, the events and circumstances discussed in such
forward-looking statements may not occur, and Pharming's actual
results could differ materially and adversely from those
anticipated or implied thereby. All forward-looking statements
contained in this press release are expressly qualified in their
entirety by the cautionary statements contained or referred to in
this section. Readers should not place undue reliance on
forward-looking statements. Any forward-looking statements speak
only as of the date of this press release and are based on
information available to Pharming as of the date of this release.
Pharming does not undertake any obligation to publicly update or
revise any forward-looking statement as a result of new
information, future events or other information.
Inside Information
This press release relates to the disclosure of
information that qualifies, or may have qualified, as inside
information within the meaning of Article 7(1) of the EU Market
Abuse Regulation.
Pharming Group N.V.
Condensed Consolidated Interim Financial
Statements in US Dollars (unaudited)
For the period ended June 30, 2024
- Condensed
consolidated interim statement of income
- Condensed
consolidated interim statement of comprehensive income
- Condensed
consolidated interim balance sheet
- Condensed
consolidated interim statement of changes in equity
- Condensed
consolidated interim statement of cash flow
CONDENSED CONSOLIDATED INTERIM STATEMENT OF
INCOME |
|
For the period ended
June 30 |
|
|
|
|
|
|
|
Amounts in US$ ‘000 |
notes |
1H 2024 |
1H 2023 |
Revenues |
7 |
129,679 |
97,438 |
Costs of sales |
9 |
(16,367) |
(9,799) |
Gross profit |
7 |
113,312 |
87,639 |
Other income |
8 |
1,257 |
22,507 |
Research and development |
|
(40,118) |
(36,534) |
General and administrative |
|
(30,707) |
(20,963) |
Marketing and sales |
|
(63,177) |
(61,013) |
Other Operating Costs |
9 |
(134,002) |
(118,510) |
Operating profit (loss) |
|
(19,433) |
(8,364) |
Fair value gain (loss) on revaluation |
18 |
5,138 |
— |
Other finance income |
10 |
2,935 |
799 |
Other finance expenses |
10 |
(4,490) |
(5,254) |
Finance result, net |
|
3,583 |
(4,455) |
Share of net profits (loss) in associates using the equity
method |
12 |
(834) |
(469) |
Profit (loss) before tax |
|
(16,684) |
(13,288) |
Income tax credit (expense) |
11 |
3,018 |
2,399 |
Profit (loss) for the period |
|
(13,666) |
(10,889) |
Basic earnings per share (US$) |
19 |
(0.020) |
(0.017) |
Diluted earnings per share (US$) |
19 |
(0.020) |
(0.017) |
CONDENSED CONSOLIDATED
INTERIM STATEMENT OF COMPREHENSIVE INCOME |
For the period ended
June 30 |
|
|
|
|
|
Amounts in US$ ‘000 |
1H 2024 |
1H 2023 |
Profit (loss) for the period |
(13,666) |
(10,889) |
Currency translation differences |
(4,235) |
3,079 |
Items that may be subsequently reclassified to profit or
loss |
(4,235) |
3,079 |
Fair value remeasurement investments |
78 |
138 |
Items that shall not be subsequently reclassified to profit
or loss |
78 |
138 |
Other comprehensive income (loss), net of tax |
(4,157) |
3,217 |
Total comprehensive income (loss) for the
period |
(17,823) |
(7,672) |
CONDENSED
CONSOLIDATED INTERIM BALANCE SHEET |
|
|
|
|
|
|
|
Amounts in US$ ‘000 |
notes |
June 30, 2024 |
December 31, 2023 |
Non-current assets |
|
|
|
Intangible assets |
|
66,572 |
71,267 |
Property, plant and equipment |
|
8,617 |
9,689 |
Right-of-use assets |
|
22,107 |
23,777 |
Long-term prepayments |
|
90 |
92 |
Deferred tax assets |
13 |
39,049 |
29,761 |
Investment accounted for using the equity method |
12 |
1,404 |
2,285 |
Investments in equity instruments designated as at FVTOCI |
12 |
— |
2,020 |
Investment in debt instruments designated as at FVTPL |
12 |
5,959 |
6,093 |
Restricted cash |
16 |
1,498 |
1,528 |
Total non-current assets |
|
145,296 |
146,512 |
Current assets |
|
|
|
Inventories |
14 |
59,190 |
56,760 |
Trade and other receivables |
|
51,119 |
46,158 |
Marketable securities |
15 |
113,181 |
151,683 |
Cash and cash equivalents |
16 |
47,142 |
61,741 |
Total current assets |
|
270,632 |
316,342 |
Total assets |
|
415,928 |
462,854 |
Equity |
|
|
|
Share capital |
|
7,748 |
7,669 |
Share premium |
|
486,850 |
478,431 |
Other reserves |
|
6,390 |
(2,057) |
Accumulated deficit |
|
(280,051) |
(265,262) |
Shareholders’ equity |
17 |
220,937 |
218,781 |
Non-current liabilities |
|
|
|
Convertible bonds |
18 |
87,323 |
136,598 |
Lease liabilities |
|
27,731 |
29,507 |
Total non-current liabilities |
|
115,054 |
166,105 |
Current liabilities |
|
|
|
Convertible bonds |
18 |
3,147 |
1,824 |
Trade and other payables |
|
72,967 |
72,528 |
Lease liabilities |
|
3,823 |
3,616 |
Total current liabilities |
|
79,937 |
77,968 |
Total equity and liabilities |
|
415,928 |
462,854 |
CONDENSED CONSOLIDATED INTERIM STATEMENT OF CHANGES IN
EQUITY |
For the
period ended June 30 |
Attributable to owners of the parent |
|
|
|
|
|
|
|
Amounts in US$ ‘000 |
notes |
Share capital |
Share premium |
Other reserves |
Accumulated deficit |
Total equity |
Balance at January 1, 2023 |
|
7,509 |
462,297 |
(8,737) |
(256,431) |
204,638 |
Profit (loss) for the period |
|
— |
— |
— |
(10,889) |
(10,889) |
Reserves |
|
— |
— |
— |
— |
— |
Other comprehensive income (loss) for the period |
|
— |
— |
3,217 |
— |
3,217 |
Total comprehensive income (loss) for the
period |
|
— |
— |
3,217 |
(10,889) |
(7,672) |
Other reserves |
17 |
— |
— |
(517) |
517 |
— |
Income tax benefit from excess tax deductions related to
share-based payments |
|
— |
— |
— |
102 |
102 |
Share-based compensation |
|
— |
— |
— |
3,970 |
3,970 |
Options exercised / LTIP shares issued |
|
31 |
2,066 |
— |
(2,763) |
(666) |
Value of conversion rights of convertible bonds |
|
— |
— |
— |
— |
— |
Total transactions with owners, recognized directly in
equity |
19 |
31 |
2,066 |
(517) |
1,826 |
3,406 |
Balance at June 30, 2023 |
|
7,540 |
464,363 |
(6,037) |
(265,494) |
200,372 |
|
|
|
|
|
|
|
Balance at January 1, 2024 |
|
7,669 |
478,431 |
(2,057) |
(265,262) |
218,781 |
Profit (loss) for the period |
|
— |
— |
— |
(13,666) |
(13,666) |
Reserves |
|
— |
— |
1,544 |
(1,544) |
— |
Other comprehensive income (loss) for the period |
|
— |
— |
(4,157) |
— |
(4,157) |
Total comprehensive income (loss) for the
period |
|
— |
— |
(2,613) |
(15,210) |
(17,823) |
Other reserves |
17 |
— |
— |
(31) |
31 |
— |
Income tax benefit from excess tax deductions related to
share-based payments |
|
— |
— |
— |
(261) |
(261) |
Share-based compensation |
|
— |
— |
— |
5,687 |
5,687 |
Options exercised / LTIP shares issued |
|
79 |
8,419 |
— |
(5,036) |
3,462 |
Value of conversion rights of convertible bonds |
|
— |
— |
11,091 |
— |
11,091 |
Total transactions with owners, recognized directly in
equity |
19 |
79 |
8,419 |
11,060 |
421 |
19,979 |
Balance at June 30, 2024 |
|
7,748 |
486,850 |
6,390 |
(280,051) |
220,937 |
CONDENSED CONSOLIDATED INTERIM STATEMENT OF CASH
FLOWS |
|
For the period
ended June 30 |
|
|
|
|
|
Amounts in $’000 |
1H 2024 |
1H 2023 |
Profit (loss) before tax |
(16,684) |
(13,288) |
Adjustments to reconcile net profit (loss) to net cash used
in operating activities: |
|
|
Depreciation, amortization, impairment of non-current assets |
5,628 |
5,468 |
Equity settled share based payments |
5,687 |
3,970 |
Fair value loss (gain) on revaluation |
(5,138) |
— |
Gain on disposal from PRV sale |
— |
(21,080) |
Other finance income |
(2,935) |
(799) |
Other finance expenses |
4,450 |
5,254 |
Share of net profits in associates using the equity method |
834 |
469 |
Other |
— |
(1,743) |
Operating cash flows before changes in working
capital |
(8,158) |
(21,749) |
Changes in working capital: |
|
|
Inventories |
(3,115) |
(10,717) |
Trade and other receivables |
(4,963) |
(5,539) |
Payables and other current liabilities |
(2,255) |
4,833 |
Restricted cash |
— |
410 |
Total changes in working capital |
(10,333) |
(11,014) |
|
|
|
Interest received |
2,370 |
799 |
Income taxes received (paid) |
(4,747) |
(442) |
Net cash flows generated from (used in) operating
activities |
(20,868) |
(32,406) |
|
|
|
Capital expenditure for property, plant and equipment |
(294) |
(986) |
Proceeds on PRV sale |
— |
21,080 |
Disposal of investment designated as at FVOCI |
1,964 |
— |
Purchases of marketable securities |
(112,453) |
(87,347) |
Proceeds from sale of marketable securities |
147,841 |
— |
Net cash flows generated from (used in) investing
activities |
37,058 |
(67,253) |
|
|
|
Payment of lease liabilities |
(2,093) |
(2,570) |
Net proceeds of issued convertible bonds |
104,802 |
— |
Repurchase of convertible bonds |
(134,922) |
— |
Interests on convertible bonds |
(2,024) |
(2,023) |
Settlement of share based compensation awards |
3,462 |
(666) |
Net cash flows generated from (used in) financing
activities |
(30,775) |
(5,259) |
|
|
|
Increase (decrease) of cash |
(14,585) |
(104,918) |
Exchange rate effects |
(14) |
2,601 |
Cash and cash equivalents at the beginning of the period |
61,741 |
207,342 |
|
|
|
Total cash and cash equivalents at June 30 |
47,142 |
105,026 |
Notes to the condensed consolidated
interim financial statementsFor the period ended
June 30, 2024
1. Company information
Pharming Group N.V. is a limited liability
public company which is listed on Euronext Amsterdam (PHARM) and on
the NASDAQ (PHAR), with its headquarters and registered office
located at:
Darwinweg 24
2333 CR Leiden
The Netherlands
2. Statement of compliance
The consolidated interim financial statements
for the six-month period ended June 30, 2024, have been
prepared in accordance with International Accounting Standard IAS
34, Interim financial reporting. The condensed consolidated interim
financial statements should be read in conjunction with the annual
financial statements for the year ended December 31, 2023,
which have been prepared in accordance with International Financial
Reporting Standards (EU-IFRS) and IFRS interpretations committee
(IFRS IC) interpretations applicable to companies reporting under
IFRS as issued by the International Accounting Standards Board
(IASB) and valid as of the balance sheet date.
These condensed consolidated interim financial
statements were authorized for issue by the Board of Directors on
July 31, 2024.
The published figures in these condensed
consolidated interim financial statements are unaudited.
3. Accounting policies
Accounting policies are consistent with those of
the financial statements for the year ended December 31, 2023.
The following EUR/USD exchange rates have been applied:
EUR/USD exchange rate |
1H 2024 |
2023 |
1H 2023 |
Period-end |
1.0760 |
1.1002 |
1.0843 |
Average |
1.0795 |
1.0790 |
1.0790 |
4. Estimates and judgements
The preparation of interim financial statements
in conformity with IAS 34 and Book 2 Title 9 of the Dutch Civil
Code requires the use of certain critical accounting estimates. It
also requires management to exercise its judgement in the process
of applying the Company’s accounting policies. In preparing these
condensed consolidated interim financial statements, the
significant judgements made by management in applying the Company’s
accounting policies were the same as those applied to the
consolidated financial statements for the year ended
December 31, 2023.
5. Going concern
In preparing and finishing the interim financial
statements the Board of Directors of Pharming have assessed the
Company’s ability to fund its operations for a period of at least
twelve months after the date the interim financial statements are
issued. Based upon the assessment on a going concern basis, the
Company has concluded that funding of its operations for a period
of twelve months, after the date the interim financial statements
are issued, is realistic and achievable. Overall, based on the
outcome of this assessment, the interim financial statements have
been prepared on a going concern basis.
6. Seasonality of
operations
Seasonality has no material impact on Company’s
interim financial statements.
7. Segment information
Operating segments are components of the Company
that engage in business activities from which it may incur
expenses, for which discrete financial information is available and
whose operating results are evaluated regularly by the Company’s
Chief Operating Decision Maker (“CODM”) to make decisions about
resources to be allocated to the segment and assess its
performance. The Executive Members of the Board of Directors are
considered the CODM.
CODM reviews the Company’s results under four
operating segments based on a combination of the products that the
Company has launched - RUCONEST® and Joenja®, and the main
geographies where sales are consummated - focused on the US and
reporting, in aggregate, EU and Rest of the World (“RoW”). The four
operating segments correspond to each of its four reportable
segments for financial reporting purposes.
The CODM reviews revenues and gross profit to
assess the performance of their operating segments. The CODM does
not review financial information on a segmental basis below gross
margin, and balance sheet information is not allocated to the
company's reportable segments. There are no intersegment sales.
Total revenues and gross profit per each
operating and reportable segment for the period ended June 30
are:
Amounts in US$ ‘000 |
1H 2024 |
1H 2023 |
|
RUCONEST® |
Joenja® |
Total |
RUCONEST® |
Joenja® |
Total |
Revenues: |
|
|
|
|
|
|
US |
106,354 |
18,657 |
125,011 |
91,032 |
3,792 |
94,824 |
EU and RoW |
2,619 |
2,049 |
4,668 |
2,614 |
— |
2,614 |
Total revenues |
108,973 |
20,706 |
129,679 |
93,646 |
3,792 |
97,438 |
|
|
|
|
|
|
|
Gross profit: |
|
|
|
|
|
|
US |
94,445 |
16,203 |
110,648 |
83,547 |
3,317 |
86,864 |
EU and RoW |
865 |
1,799 |
2,664 |
775 |
— |
775 |
Total gross profit |
95,310 |
18,002 |
113,312 |
84,322 |
3,317 |
87,639 |
8. Other income
Other income decreased by US$21.3 million in the
first half of 2024 to US$1.3 million as compared to US$22.5 million
the first half of 2023. The main reason was the gain on the sale of
a Priority Review Voucher (PRV) to Novartis as part of the license
agreement (US$21.3 million) in 2023.
9. Expenses by nature
Costs of sales
Amounts in US$ ‘000 |
1H 2024 |
1H 2023 |
Cost of inventories recognized as expenses |
(10,738) |
(8,425) |
Royalty fees |
(2,502) |
(455) |
Obsolete inventory impairments |
(3,127) |
(919) |
Total |
(16,367) |
(9,799) |
Costs of inventories recognized as expenses in
the first half year of 2024 were US$10.7 million versus US$8.4
million for the first half of 2023 and relates to actual product
sales of RUCONEST® and Joenja®.
Pharming expensed royalty fees to Novartis on
Joenja® sales, amounting to US$2.5 million in the first half of
2024 (first half of 2023: US$0.5 million).
Obsolete inventory impairments amounted to
US$3.1 million (1H 2023: US$0.9 million) and stems from the
valuation of the inventories against lower net realizable value and
mainly relates to products no longer eligible for commercial
sales.
Other operating costs
Other operating costs increased to US$134.0
million in the first half of 2024 compared to US$118.5 million in
the first half year of 2023.
Employee benefits are charged to research and
development costs, general and administrative costs, or marketing
and sales costs based on the nature of the services provided.
Employee benefits of production related employees have been
included in the value of inventories.
Depreciation and amortization charges amounted
to US$5.6 million in the first half of 2024 compared to US$5.5
million the first half year of 2023, and related to the
following:
Amounts in US$ ‘000 |
1H 2024 |
1H 2023 |
Property, plant and equipment |
(763) |
(713) |
Right-of-use assets |
(1,728) |
(1,809) |
Intangible assets |
(3,137) |
(2,946) |
Total |
(5,628) |
(5,468) |
10. Finance income
(expenses)
Amounts in US$ ‘000 |
1H 2024 |
1H 2023 |
Foreign currency results |
236 |
— |
Interest income |
2,699 |
799 |
Other finance income |
2,935 |
799 |
Foreign currency results |
— |
(2,271) |
Fees and expenses on repayment and issuance convertible bonds |
(920) |
— |
Amortization and interest on convertible bonds |
(3,005) |
(2,414) |
Interest leases |
(525) |
(555) |
Other finance expenses |
(40) |
(14) |
Other finance expenses |
(4,490) |
(5,254) |
Total other finance income and expenses |
(1,555) |
(4,455) |
Foreign currency results mainly stem from
fluctuations in the EUR/USD exchange rate. The euro got stronger
during the first half of 2024 where it weakened during the first
half of 2023. This impacts the revaluation of the bank balances in
US dollars incorporated in euro functional currency entities and
the receivables and payables in euro incorporated in our USD
functional currency entity.
Since the second quarter of 2023, the Company
has used excess cash to invest in euro denominated readily
convertible S&P AAA-rated government treasury certificates with
a maturity of six months or less from the date of acquisition. As a
result of these purchases, the interest income has increased
significantly compared to 2023.
11. Income tax (expenses)
Income tax expenses are recognized in each
interim period based on the best estimate of the weighted average
annual income tax rate expected for the full financial year.
12. Investments
Investments accounted for using the equity
method
The asset relates to an investment in the
ordinary shares of BioConnection Investments B.V. In the Board of
Directors’ judgement, the investment in BioConnection constitutes
an investment in an associated company and is therefore not
consolidated. Pharming has significant influence but does not have
control of BioConnection and is embargoed by a shareholder’s
agreement between the shareholders of BioConnection from
influencing any activity between the two parties which is in any
significant way different from the relationship which existed
between the two prior to the investment.
The carrying amount of this investment has
changed as follows:
Amounts in US $ ‘000 |
Period toJune 30, 2024 |
Period toDecember 31, 2023 |
Balance at January 1 |
2,285 |
2,501 |
Share in net profit (loss) for the period |
(834) |
(289) |
Currency translation |
(47) |
73 |
Balance at end of period |
1,404 |
2,285 |
Investment in debt instruments designated as at
FVTPL
The asset relates to the preference share in
BioConnection Investments B.V. The Board of Directors made an
assessment on the accounting treatment of the preference share
obtained. The Board concluded that the asset should be recognized
as a financial asset (debt instrument) measured at initial
recognition at fair value, subsequently measured at fair value
through profit and loss. The fair value is calculated on a yearly
basis using the forward-looking Black-Scholes-Merton (“BSM”)
financial instrument pricing framework. No events or matters are
known as of the date of this report which would lead to a
significant impact in the fair value of the asset, compared to
December 31, 2023.
The carrying amount of this investment has
changed as follows:
Amounts in US $ ‘000 |
Period toJune 30, 2024 |
Period toDecember 31, 2023 |
Balance at January 1 |
6,093 |
6,827 |
Fair value changes |
— |
(930) |
Currency translation |
(134) |
196 |
Balance at end of period |
5,959 |
6,093 |
Investment in equity instruments designated as
at FVTOCI
The Group held 0.54 per cent of the ordinary
share capital of Orchard Therapeutics, a global gene therapy leader
per December 31, 2023.
On 5 October 2023, Orchard announced it had
entered into a definitive agreement with Japanese company Kyowa
Kirin Co. LTD for the acquisition of Orchard for US$16.00 per
American Depositary Share (ADS) in cash plus an additional
contingent value right (CVR) of US$1.00 per ADS (a total of
US$17.00 per ADS). The transaction was successfully completed on 24
January 2024. Based on the offer price per ADS of US$16.00, the
Company has received US$2.0 million for its shares held in Orchard
Therapeutics in 2024. In addition, the Company has been notified it
will receive the full value of the CVR (US$1.00 per ADS), amounting
to US$0.1 million.
The carrying amount of this investment has
changed as follows:
Amounts in US $ ‘000 |
Period toJune 30, 2024 |
Period toDecember 31, 2023 |
Balance at January 1 |
2,020 |
403 |
Fair value adjustments through OCI |
78 |
1,573 |
Disposal |
(2,087) |
— |
Currency translation |
(11) |
44 |
Balance at end of period |
— |
2,020 |
13. Deferred tax assets
The deferred tax asset increased mainly due to
the addition of the current year loss to the DTA for Net operating
losses.
14. Inventories
Inventories include batches of Joenja® and
RUCONEST® and relating work in progress which are available for
production.
Amounts in US$ ‘000 |
June 30, 2024 |
December 31, 2023 |
Finished goods |
17,526 |
18,349 |
Work in progress |
41,111 |
37,706 |
Raw materials |
553 |
705 |
Balance at end of period |
59,190 |
56,760 |
Changes in the adjustment to net realizable
value:
Amounts in US $ ‘000 |
Period toJune
30,2024 |
Period to December
31,2023 |
Balance at January 1 |
(4,276) |
(1,971) |
Addition to impairment |
(6,840) |
(3,878) |
Usage of impairment |
2,230 |
1,673 |
Currency translation |
109 |
(100) |
Balance at end of period |
(8,777) |
(4,276) |
The inventory valuation at June 30, 2024,
of US$59.2 million (December 31, 2023: US$56.8 million) is
stated net of an impairment of US$8.8 million (December 31,
2023: US$4.3 million). The impairment includes impairment for
obsolescence and impairment to write inventories down to their net
realizable value.
Inventories are available for use in commercial,
preclinical and clinical activities. Estimates have been made with
respect to the ultimate use or sale of product, taking into account
current and expected sales as well as preclinical and clinical
programs. These estimates are reflected in the additions to the
impairment. The costs of vials used in preclinical and clinical
programs are presented under the research and development
costs.
The main portion of inventories at June 30,
2024, have expiration dates starting beyond 2024 and are all
expected to be sold and/or used before expiration.
15. Marketable securities
Marketable securities consist of
euro-denominated readily convertible S&P AAA-rated government
treasury certificates with a maturity of six months or less from
the date of acquisition and are classified as held-to-maturity. The
marketable securities are measured at amortized costs and amount to
US$113.2 million as of June 30, 2024 (December 31, 2023:
US$151.7 million). This includes accrued interest of US$0.9 million
as of June 30, 2024 (December 31, 2023: US$0.7
million).
16. Restricted cash, cash and
cash equivalents
Amounts in US$ ‘000 |
June 30, 2024 |
December 31, 2023 |
Restricted cash (non-current) |
1,498 |
1,528 |
Cash and cash equivalents |
47,142 |
61,741 |
Total restricted cash, cash and cash
equivalents |
48,640 |
63,269 |
Cash is free at disposal of the Company, except
for restricted cash. Restricted cash (non-current) includes a
deposit for rent which is considered long-term.
For purposes of the cash flow statement,
restricted cash is not considered as ''cash and cash
equivalents''.
17. Equity
The Company’s authorized share capital amounts
to €10.6 million (US$11.4 million) and is divided into
1,056,000,000 ordinary shares with a nominal value of €0.01 each.
All 678,354,325 shares outstanding at June 30, 2024, have been
fully paid-up. Other reserves include those reserves related to
currency translation, share-based compensation expenses and other
equity-settled transactions.
Please refer to the Condensed consolidated
interim statement changes in Equity.
The other reserves are made up as shown in the
below table.
Amounts in $ ‘000 |
Legal reserve Currency translation reserve
(CTA) |
Legal Reserve Capitalized development cost |
Legal Reserve participating interest |
Reserve Fair value revaluation |
Reserve Convertible bond |
Total |
Balance at January 1, 2023 |
(6,384) |
402 |
233 |
(2,988) |
— |
(8,737) |
Movement in the period |
3,198 |
(402) |
(233) |
138 |
— |
2,701 |
Balance at June 30, 2023 |
(3,186) |
— |
— |
(2,850) |
— |
(6,036) |
|
|
|
|
|
|
|
Balance at January 1, 2024 |
(343) |
106 |
— |
(1,821) |
— |
(2,058) |
Movement in the period |
(4,433) |
(31) |
— |
1,821 |
11,091 |
8,448 |
Balance at June 30, 2024 |
(4,776) |
75 |
— |
— |
11,091 |
6,390 |
18. Convertible bonds
In April 2024, the Company offered €100 million
(US$108 million) of senior unsecured convertible bonds due 2029
(the “New Bonds”) convertible into new and/or existing ordinary
shares in the capital of the Company. The offer was fully
subscribed. The net proceeds of the issue of the bonds were used
for the repurchase of the outstanding €125 million (US$135 million)
3.00% senior unsecured convertible bonds due 2025 issued on 21
January 2020 (ISIN: XS2105716554), which has been launched
concurrently to the offering of the New Bonds to strengthen its
financial position while enhancing flexibility for the continued
execution of its business strategy over the next several years.
The New Bonds have a principal amount of
€100,000 each. The New Bonds are issued at par and carry a coupon
of 4.50% per annum payable semi-annually in arrears in equal
installments on 25th April and 25th October of each year,
commencing on 25th October 2024. Unless previously converted,
redeemed or purchased and cancelled, the New Bonds will be redeemed
at par on 25th April 2029.
The initial conversion price has been set at
€1.2271 (US$1.3204), representing a premium of 37.5% above the
volume weighted average price (VWAP) of a Share on Euronext
Amsterdam between opening of trading on the launch date and the
pricing of the offering (i.e. €0.8924 (US$0.9602)). The initial
conversion price of the New Bonds will be subject to customary
adjustment provisions as set out in the terms and conditions. The
number of ordinary shares initially underlying the New Bonds is
81,492,951, representing 12% of the Company’s current issued share
capital. The New Bonds are listed on the Frankfurt Exchange (ISIN:
XS2763018889).
The New Bonds are classified as hybrid financial
instruments under IAS 32 and pursuant to it the debt host contract
and the embedded derivative for the fair value of the conversion
rights into Pharming shares (the “conversion option”) are
recognized separately. Initial recognition values for the
individual components were determined as follows:
- the conversion
option at recognition was measured using a pricing model. As the
Company did not have sufficient placement capacity to fulfil
conversion of the New Bonds into ordinary shares at the date of
issue, the conversion option was recognized as a financial
liability derivative. During the shareholder’s meeting on May 21,
2024, the Company received shareholder approval to increase share
capital to support the potential conversion. At the Physical
settlement notice date of June 11, 2024, when the New Bond
holders were notified that the cash settlement alternative would no
longer be available, the conversion option was reclassified to
equity at fair value, which resulted in a fair value gain of US$5.1
million immediately prior to the reclassification. Subsequently,
the value of this equity component is not remeasured and amounts to
US$11.1 million at June 30, 2024.
- the debt host
contract component was measured as the difference between the
proceeds from the bond and the value of the conversion option at
initial recognition. This debt host contract is subsequently
measured at amortized cost, which amounts to US$90.5 million at
June 30, 2024.
Direct costs associated with the issue of the
New Bonds were allocated to the debt host contract (US$2.4 million)
and the conversion option (US$0.4 million) in amounts proportional
to the above mentioned initial value. They were accounted for
respectively in the amortized cost (debt host contract) and in the
income statement (conversion option).
The movements of the convertible bonds were as
follows:
Amounts in US$ ‘000 |
Period toJune
30,2024 |
Period to December
31,2023 |
Balance at January 1 |
138,422 |
133,386 |
Carrying value initial recognition |
88,823 |
— |
Interest paid (cash flow) |
(2,024) |
(4,046) |
Amortization |
1,796 |
830 |
Accrued interest |
1,957 |
4,046 |
Carrying value repurchase |
(134,922) |
— |
Currency translation |
(3,582) |
4,206 |
Carrying value at end of period |
90,470 |
138,422 |
19. Earnings per share and
diluted shares
Basic earnings per share is calculated based on
the weighted average number of ordinary shares outstanding during
the period. Diluted earnings per share in the case of a profit is
computed based on the weighted average number of ordinary shares
outstanding including the dilutive effect of shares to be issued in
the future under certain arrangements such as option plans.
However, as the net result represents a loss, the diluted earnings
per share are equal to the basic earnings per share. For 1H 2024
and 1H 2023, the basic and diluted earnings per share are:
|
1H 2024 |
1H 2023 |
Net profit (loss) attributable to equity owners of the parent (in
US $ '000) |
(13,666) |
(10,889) |
Weighted average shares outstanding (in '000) |
672,068 |
657,270 |
Basic profit (loss) per share (in US$) |
(0.020) |
(0.017) |
Weighted average fully-diluted shares outstanding (in
'000) |
785,511 |
724,060 |
Fully-diluted profit per share (in US$) |
(0.020) |
(0.017) |
Diluted shares
The composition of the number of shares and
share rights outstanding as well as authorized share capital as per
June 30, 2024 is provided in the table below:
Amounts in '000 |
December 31, 2023 |
Shares issued |
Other |
June 30, 2024 |
Issued shares |
671,073 |
7,281 |
— |
678,354 |
RSU |
11,187 |
(65) |
(145) |
10,977 |
Options |
34,482 |
(5,806) |
(3,851) |
24,825 |
Convertible bonds |
62,413 |
|
19,080 |
81,493 |
LTIP |
17,534 |
(1,235) |
3,353 |
19,652 |
Fully-diluted shares |
796,690 |
174 |
18,437 |
815,300 |
Available for issue |
259,310 |
(174) |
(18,437) |
240,700 |
Authorized share capital |
1,056,000 |
— |
— |
1,056,000 |
20. Financial risk management
and fair value
Financial risk management
Pharming is exposed to several financial risks:
market risks (being currency risk and interest rate risk), credit
risks and liquidity risks. The Board of Directors and the Executive
Committee are responsible for the management of currency, interest,
credit and liquidity risks and as such ultimately responsible for
decisions taken in this field. The Group’s exposure to financial
risks has not materially changed during the period.
Fair value
For the convertible bond, lease liabilities
trade payables and other liabilities, the carrying amount is a
reasonable approximation of fair value. During the six-month period
ended June 30, 2024, there have been no changes related to the
fair value hierarchy.
20. Related party transactions
There are no material changes in the nature,
scope, and scale in this reporting period compared to last year.
More information is included in note 24 to the consolidated
financial statements as at and for the year ended December 31,
2023.
21. Events since the end of the reporting
period
There were no significant events since the end
of the reporting period.
- Pharming reports 2Q_1H 2024 financial results_EN_01AUG24
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