Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader,
today announced several business accomplishments along with its
financial results for the quarter ended September 30, 2023.
“With strong execution across our key
commercial, regulatory and clinical priorities, 2023 has been a
transformational year for Orchard Therapeutics, culminating with
the announcement of the planned acquisition by Kyowa Kirin,” said
Bobby Gaspar, M.D., Ph.D., chief executive officer. “As we enter
this next phase in the company’s evolution, we look forward to
collaborating with our new colleagues after closing to fully unlock
the curative potential of HSC gene therapy for the benefit of
patients and society.”
Dr. Gaspar continued, “With our BLA file for
OTL-200 in MLD accepted by the FDA under Priority Review, we are
one step closer to potentially bringing this important therapy to
families in the U.S. Due to the nature of the disease and the
urgency to treat children affected by MLD, we are working
diligently in parallel to prepare for a potential launch in 2024
and ensure OTL-200 will be available to patients in the U.S. as
quickly as possible. In addition, we remain well-positioned to
continue investing in initiatives aimed at accelerating commercial
growth in Europe and advancing our next-in-line neurometabolic
programs in MPS disorders. The next 12 months have the potential to
provide Orchard Therapeutics with several breakout opportunities
that we believe would cement our leadership position in the HSC
gene therapy field.”
Planned Acquisition of Orchard
Therapeutics by Kyowa Kirin
Last month, the company entered into a
definitive agreement under which Kyowa Kirin will acquire Orchard
Therapeutics, subject to certain closing conditions. Under the
terms of the agreement, Kyowa Kirin will initiate a scheme of
arrangement to acquire all outstanding shares of Orchard
Therapeutics at a price of $16.00 per American Depositary Share
(ADS) in cash (or an aggregated value of approximately $387.4
million) at closing, which represented a premium of 144% to Orchard
Therapeutics’ volume-weighted average price per ADS over the 30
days ended October 4, 2023, the day before the transaction was
announced.
In connection with the transaction, an
additional contingent value right (CVR) of $1.00 per ADS is payable
for a total of $17.00 per ADS, or an aggregated total transaction
value of approximately $477.6 million, which includes certain
warrants to purchase Orchard shares. The CVR payments are
contingent and payable only on U.S. approval of OTL-200 in 2024 per
the terms of the CVR agreement.
The transaction has been unanimously approved by
both company’s Boards of Directors and is expected to close in the
first quarter of 2024 subject to Orchard Therapeutics’ shareholder
approval, receipt of applicable regulatory approvals and other
customary closing conditions. A preliminary proxy statement has
been filed with the U.S. Securities and Exchange Commission.
Following the completion of the acquisition,
Orchard Therapeutics will become a wholly-owned subsidiary of Kyowa
Kirin.
BLA for OTL-200 in MLD Accepted by FDA
Under Priority Review
In September, the U.S. Food and Drug
Administration (FDA) accepted the filing of the company’s Biologics
License Application (BLA) for OTL-200 in metachromatic
leukodystrophy (MLD) under Priority Review. The agency has set a
Prescription Drug User Fee Act (PDUFA) goal date of March 18,
2024.
OTL-200 previously received both Rare Pediatric
Disease (RPD) and Regenerative Medicine Advanced Therapy (RMAT)
designations from the FDA and is approved as Libmeldy®
(atidarsagene autotemcel) by the European Commission (EC) and UK
Medicines and Healthcare products Regulatory Agency (MHRA).
Commercial Updates and Newborn Screening
Progress
- In October, the Institute for
Clinical and Economic Review (ICER), an independent non-profit
research organization that analyzes the evidence on the
effectiveness and value of medical treatments and services,
published its Final Evidence Report on OTL-200.
- ICER has determined an estimated
value-based price benchmark for OTL-200 to be between $2.3 to $3.9
million. The upper end of the range is the highest for any therapy
ICER has ever assessed and is based on a cost-effectiveness
calculation at the threshold of $150,000 per equal-value life-year
gained.
- Moreover, ICER gave OTL-200 the
highest possible evidence rating with high certainty of a
substantial net health benefit (“A”) for the pre-symptomatic late
infantile and pre-symptomatic early juvenile populations and better
than average with moderate certainty of a substantial net health
benefit versus usual care (“B+”) for the early-symptomatic early
juvenile subgroup.
- In its totality, the Final Evidence
Report provides additional support for the company’s payer and
reimbursement discussions in the U.S. and around the world.
- As the company continues to prepare
for the potential launch of OTL-200, it is building out its
regional team beginning with the appointment of Bennett Smith as
senior vice president and general manager of North America.
- Mr. Smith brings more than two
decades of biopharmaceutical experience to Orchard Therapeutics,
having served in leadership roles encompassing all commercial
functions, including marketing, sales, market access and patient
services. Prior to joining Orchard, Mr. Smith was senior vice
president of commercial at Akebia Therapeutics. In this role, he
served as an accomplished launch leader who simultaneously drove
revenue growth for Akebia’s in-line asset following the integration
with Keryx Biopharmaceuticals.
- Ten prospective newborn screening
studies are active throughout Europe, the U.S. and the Middle East,
with approximately 200,000 babies screened.
- To date, four confirmed cases of
MLD have been identified through these studies. Eligible patients
identified through newborn screening in Europe will continue to be
treated commercially with Libmeldy in 2023 and beyond, adding to
the referrals being generated through early symptomatic diagnosis
and family screening.
- The data from these studies will
provide critical evidence to support applications for universal
screening of MLD in the U.S. and around the world.
- Furthering those efforts, the
Illinois state legislature passed the Newborn Metabolic Screening
Act, also known as SB67, which requires the state Department of
Public Health to screen all newborns for MLD. The bill was signed
by the governor in August, and it is expected Illinois will start
the process of implementing statewide screening for MLD this
year.
Recent Data Presentations
Eight presentations highlighting the
differentiated profile and potential broad applicability of the
company’s hematopoietic stem cell (HSC) gene therapy platform were
featured last month at the European Society of Gene and Cell
Therapy (ESGCT) 30th Annual Congress in Brussels.
Data highlights included:
- A range of interim clinical
outcomes in addition to the biochemical, neurological and skeletal
results previously reported from the company’s proof-of-concept
study of OTL-203 in the Hurler subtype of mucopolysaccharidosis
type I (MPS-IH). These new data demonstrate favorable outcomes for
disease manifestations not effectively addressed by the current
standard of care.
- A presentation supporting
pre-clinical efficacy of OTL-204 which showed the ability of HSC
gene therapy to restore microglial function, modulate
neuroinflammation, and normalize predictive biomarkers in the
progranulin form of frontotemporal dementia (GRN-FTD).
- A first look at pre-clinical data
demonstrating the use of vectorized HSCs as a delivery vehicle for
monoclonal antibodies.
- Additional abstracts from the
company’s pre-clinical research programs showing the therapeutic
potential of HSC gene therapy to address larger indications,
including a genetic sub-type of Crohn’s disease and chronic
autoimmune disorders.
In August, the company also presented data
comprising the clinical package for the OTL-200 BLA in MLD at the
Society for the Study of Inborn Errors of Metabolism (SSIEM) Annual
Symposium in Jerusalem. Results showed that the administration of
one-time gene therapy resulted in statistically significant
improvement in severe motor impairment-free survival with up to 12
years of follow-up (median 6.76 years).
Remaining 2023 Expected
Milestones
Orchard Therapeutics has outlined the following
key milestones expected for the remainder of 2023:
- Libmeldy for MLD: Continue to
establish additional qualified treatment centers and expand newborn
screening activities throughout Europe and the Middle East.
- OTL-200 for MLD: Prepare for
potential U.S. launch, including establishing qualified treatment
centers and expanding newborn screening activities in the country,
in the first half of 2024 following an anticipated FDA decision on
March 18, 2024.
- OTL-203 for MPS-IH: Initiate a
global, multi-center registrational trial by year end.
- OTL-104 for NOD2-Crohn’s disease:
Commence IND- and CTA-enabling studies by year end, ahead of a
potential filing in 2025.
- Advance the company’s other
pre-clinical programs, which includes OTL-204 in the progranulin
form of FTD and OTL-105 partnered with and funded by Pharming Group
N.V. in hereditary angioedema (HAE).
Third Quarter 2023 Financial
Results
Total revenue was $6.3 million for the three
months ended September 30, 2023, comprising $5.6 million in
Libmeldy revenue and $0.7 million in collaboration revenue. This
compares to total revenue of $5.8 million in the same period in
2022, comprising $5.4 million in Libmeldy revenue and $0.4 million
in collaboration revenue. The cost of product sales, which includes
the cost of manufacturing, royalties to third parties and non-cash
amortization, was $1.7 million during the third quarter of 2023
compared to $1.6 million in the same period in 2022. The company
reported gross margins of approximately 72% for the three months
ended September 30, 2023, consistent with previous quarters.
For the three months ended September 30, 2023,
the company reported research and development (R&D) expenses of
$14.6 million, compared to $18.1 million in the same period in
2022, a decrease of 19%. The decline was primarily the result of
the release of the Strimvelis loss provision ($2.9 million)
following the previously announced European marketing authorization
transfer to the therapy’s originator.
For the three months ended September 30, 2023,
the company reported selling, general and administrative (SG&A)
expenses of $11.6 million consistent with the $11.5 million
reported in the same period in 2022.
Loss from operations was $21.6 million in the
three months ended September 30, 2023, compared to a loss from
operations of $25.5 million in the corresponding period of 2022, a
decrease of 15%. The decline was primarily the result of a $3.5
million decrease in R&D expenses.
Total other income (loss) was $12.7 million for
the three months ended September 30, 2023. The company reported an
$8.8 million loss relating to the fair value remeasurement of
warrants that were issued in connection with the first and second
closings of the strategic financing entered into in March 2023. The
outstanding warrants will continue to be remeasured in future
periods resulting in non-cash gains or losses based on a number of
valuation assumptions on the underlying financial instruments. In
addition, the U.S. dollar has strengthened against the British
pound and Euro throughout the third quarter of 2023, resulting in
unrealized losses on certain intercompany balances denominated in
currencies other than the U.S. dollar.
Net loss was $35.3 million for the three months
ended September 30, 2023, compared to $47.6 million in the same
period in 2022, a reduction of 26%. The company had approximately
227.3 million ordinary shares, equivalent to 22.7 million American
Depositary Shares, outstanding as of September 30, 2023.
As of September 30, 2023, the company reported
cash, cash equivalents and investments of approximately $125.4
million, with $25.6 million of debt outstanding, compared to $148.0
million and $32.4 million of debt outstanding as of December 31,
2022. As a result of the anticipated acquisition by Kyowa Kirin,
Orchard Therapeutics has removed its financial guidance around
Libmeldy revenue and anticipated cash runway. The company expects
that its existing cash, cash equivalents and investments will fund
its anticipated operating, debt service and capital expenditure
requirements for at least twelve months from the date of the filing
of its Form 10-Q for the quarter ended September 30, 2023.
About Libmeldy /
OTL-200Libmeldy® (atidarsagene autotemcel), also known as
OTL-200, has been approved by the European Commission for the
treatment of MLD in eligible early-onset patients characterized by
biallelic mutations in the ARSA gene leading to a reduction of the
ARSA enzymatic activity in children with i) late infantile or early
juvenile forms, without clinical manifestations of the disease, or
ii) the early juvenile form, with early clinical manifestations of
the disease, who still have the ability to walk independently and
before the onset of cognitive decline. Libmeldy is the first
therapy approved for eligible patients with early-onset MLD.
The most common adverse reaction attributed to
treatment with Libmeldy was the occurrence of anti-ARSA antibodies.
In addition to the risks associated with the gene therapy,
treatment with Libmeldy is preceded by other medical interventions,
namely peripheral blood mobilization and apheresis, followed by
myeloablative conditioning, which carry their own risks. During the
clinical studies of Libmeldy, the safety profiles of these
interventions were consistent with their known safety and
tolerability.
For more information about Libmeldy, please see
the Summary of Product Characteristics (SmPC) available on the
European Medicines Agency (EMA) website.
Libmeldy is approved in the European Union, UK,
Iceland, Liechtenstein and Norway. OTL-200 is an investigational
therapy in the U.S.
Libmeldy was developed in partnership with the
San Raffaele-Telethon Institute for Gene Therapy (SR-Tiget) in
Milan, Italy.
About Orchard TherapeuticsAt
Orchard Therapeutics, our vision is to end the devastation caused
by genetic and other severe diseases. We aim to do this by
discovering, developing and commercializing new treatments that tap
into the curative potential of hematopoietic stem cell (HSC) gene
therapy. In this approach, a patient’s own blood stem cells are
genetically modified outside of the body and then reinserted, with
the goal of correcting the underlying cause of disease in a single
treatment.
In 2018, the company acquired GSK’s rare disease
gene therapy portfolio, which originated from a pioneering
collaboration between GSK and the San Raffaele Telethon Institute
for Gene Therapy in Milan, Italy. Today, Orchard is advancing a
pipeline spanning pre-clinical, clinical and commercial stage HSC
gene therapies designed to address serious diseases where the
burden is immense for patients, families and society and current
treatment options are limited or do not exist.
Orchard has its global headquarters
in London and U.S. headquarters in Boston. For
more information, please visit www.orchard-tx.com, and follow
us on Twitter and LinkedIn.
Availability of Other Information About
OrchardInvestors and others should note that Orchard
communicates with its investors and the public using the company’s
website (www.orchard-tx.com), the investor relations website
(ir.orchard-tx.com), and on social media
(Twitter and LinkedIn), including but not limited to
investor presentations and investor fact sheets, U.S.
Securities and Exchange Commission (SEC) filings, press
releases, public conference calls and webcasts. The information
that Orchard posts on these channels and websites could be deemed
to be material information. As a result, Orchard encourages
investors, the media, and others interested in Orchard to review
the information that is posted on these channels, including the
investor relations website, on a regular basis. This list of
channels may be updated from time to time on Orchard’s investor
relations website and may include additional social media channels.
The contents of Orchard’s website or these channels, or any other
website that may be accessed from its website or these channels,
shall not be deemed incorporated by reference in any filing under
the Securities Act of 1933.
Additional Information and Where to Find
It In connection with the proposed transaction between
Kyowa Kirin Co., Ltd. (“Kyowa Kirin”) and Orchard
Therapeutics plc (“Orchard”), Orchard has filed
with the Securities and Exchange Commission (the
“SEC”) a Proxy Statement, the definitive version
of which (if and when available) will be mailed to Orchard security
holders. Orchard may also file other documents with the SEC
regarding the proposed transaction. This document is not a
substitute for the Proxy Statement or any other document which
Orchard may file with the SEC. INVESTORS AND SECURITY HOLDERS ARE
URGED TO READ THE PROXY STATEMENT (WHICH WILL INCLUDE AN
EXPLANATORY STATEMENT IN RESPECT OF THE SCHEME OF ARRANGEMENT OF
ORCHARD, IN ACCORDANCE WITH THE REQUIREMENTS OF THE U.K. COMPANIES
ACT 2006) AND ANY OTHER RELEVANT DOCUMENTS THAT ARE FILED OR WILL
BE FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO
THESE DOCUMENTS, CAREFULLY AND IN THEIR ENTIRETY IF AND WHEN THEY
BECOME AVAILABLE BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT
INFORMATION ABOUT THE PROPOSED TRANSACTION AND RELATED MATTERS.
Investors and security holders may obtain a free copy of the Proxy
Statement and other relevant documents containing important
information about Kyowa Kirin, Orchard and the proposed transaction
(if and when they become available) once such documents are filed
with the SEC at the SEC’s website at www.sec.gov. Copies of the
documents filed with the SEC by Orchard will be available free of
charge on Orchard’s website at ir.orchard-tx.com or by contacting
Orchard’s Investor Relations Department at
investors@orchard-tx.com.
Participants in the
Solicitation Orchard and certain of its directors and
executive officers may be deemed to be participants in the
solicitation of proxies in respect of the proposed transaction.
Information regarding Orchard’s directors and executive officers,
including a description of their direct interests, by security
holdings or otherwise, is contained in Orchard’s proxy statement
for its 2023 annual general meeting of shareholders, which was
filed with the SEC on April 27, 2023, and subsequent statements of
beneficial ownership on file with the SEC. Orchard shareholders may
obtain additional information regarding the direct and indirect
interests of the participants in the solicitation of proxies in
connection with the proposed transaction, including the interests
of Orchard directors and executive officers in the transaction,
which may be different than those of Orchard shareholders
generally, by reading the Proxy Statement if and when it is filed
with the SEC and any other relevant documents that are filed or
will be filed with the SEC relating to the transaction. You may
obtain free copies of these documents using the sources indicated
above.
Cautionary Statement Regarding
Forward-Looking Statements This communication contains
“forward-looking statements” within the meaning of the federal
securities laws, including Section 27A of the Securities Act of
1933, as amended, and Section 21E of the Exchange Act. These
forward-looking statements are based on Orchard’s current
expectations, estimates and projections about the expected date of
closing of the proposed transaction and the potential benefits
thereof, its business and industry, management’s beliefs and
certain assumptions made by Orchard and Kyowa Kirin, all of which
are subject to change. In this context, forward-looking statements
often address expected future business and financial performance
and financial condition, and often contain words such as “expect,”
“anticipate,” “intend,” “plan,” “believe,” “could,” “seek,” “see,”
“will,” “may,” “would,” “might,” “potentially,” “estimate,”
“continue,” “expect,” “target,” “explore,” “evaluate,” “predict,”
“project,” similar expressions or the negatives of these words or
other comparable terminology that convey uncertainty of future
events or outcomes. All forward-looking statements by their nature
address matters that involve risks and uncertainties, many of which
are beyond Orchard’s or Kyowa Kirin’s control, and are not
guarantees of future results, such as statements about the
consummation of the proposed transaction and the anticipated
benefits thereof. These and other forward-looking statements, are
not guarantees of future results and are inherently subject to
risks, uncertainties and assumptions that could cause actual
results to differ materially from those expressed in any
forward-looking statements. Accordingly, there are or will be
important factors that could cause actual results to differ
materially from those indicated in such statements and, therefore,
you should not place undue reliance on any such statements and
caution must be exercised in relying on forward-looking statements.
Important risk factors and uncertainties that may cause such a
difference include, but are not limited to, risks and uncertainties
surrounding: (i) the completion of the proposed transaction on
anticipated terms and timing, including in connection with
obtaining shareholder and regulatory approvals, the sanction of the
High Court of Justice of England and Wales, satisfaction of other
closing conditions to consummate the acquisition, anticipated tax
treatment, unforeseen liabilities, future capital expenditures,
revenues, expenses, earnings, synergies, economic performance,
indebtedness, financial condition, losses, future prospects,
business and management strategies for the management, expansion
and growth of Orchard’s business and other conditions to the
completion of the transaction; (ii) the occurrence of any event,
change or other circumstance that could give rise to the
termination of the definitive transaction agreement relating to the
proposed transaction; (iii) Orchard’s ability to implement its
business model and strategic plans for its product, product
candidates and pipeline, and challenges inherent in developing,
commercializing, manufacturing, launching, marketing and selling
existing and new products; (iv) significant transaction costs
associated with the proposed transaction; (v) potential litigation
relating to the proposed transaction; (vi) the risk that
disruptions from the proposed transaction will harm Orchard’s
business, including current plans, operations and collaborations,
and including as a result of diverting the attention of Orchard’s
and Kyowa Kirin’s management from ongoing business operations;
(vii) the ability of Orchard to retain and hire key personnel;
(viii) potential adverse reactions or changes to business
relationships resulting from the announcement or completion of the
proposed transaction; (ix) legislative, regulatory and economic
developments affecting Orchard’s business; (x) general economic and
market developments and conditions; (xi) the evolving legal,
regulatory and tax regimes under which Orchard operates; (xii)
potential business uncertainty, including changes to existing
business relationships, during the pendency of the transaction that
could affect Orchard’s financial performance; (xiii) restrictions
during the pendency of the proposed transaction that may impact
Orchard’s ability to pursue certain business opportunities or
strategic transactions; (xiv) the risk that Orchard may be unable
to obtain governmental and regulatory approvals required for the
proposed transaction, or that required governmental and regulatory
approvals may delay the consummation of the proposed transaction or
result in the imposition of conditions that could reduce the
anticipated benefits from the proposed transaction or cause the
parties to abandon the proposed transaction; (xv) unpredictability
and severity of catastrophic events, including, but not limited to,
global pandemic, acts of terrorism or outbreak of war or
hostilities, as well as Orchard’s response to any of the
aforementioned factors; (xvi) potential delays or failures related
to research, clinical trials and/or development of Orchard’s
programs or product candidates, which are based on novel gene
therapy and (xvii) the risks related to non-achievement of the CVR
milestone and that holders of the CVRs will not receive payments in
respect of the CVRs. Additional factors that may affect the future
results of Orchard are set forth in Orchard’s filings with the SEC,
including Orchard’s most recently filed Annual Report on Form 10-K,
subsequent Quarterly Reports on Form 10-Q, Current Reports on Form
8-K and other filings with the SEC, which are available on the
SEC’s website at www.sec.gov. See in particular Item 1A of
Orchard’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2022 and Quarterly Report on Form 10-Q for the
quarterly period ended September 30, 2023 under the headings “Risk
Factors.” The risks and uncertainties described above and in the
SEC filings cited above are not exclusive and further information
concerning Orchard and its business, including factors that
potentially could materially affect Orchard’s business, financial
conditions or operating results, may emerge from time to time.
Moreover, other risks and uncertainties of which Orchard is not
currently aware may also affect Orchard’s forward-looking
statements and may cause actual results and the timing of events to
differ materially from those anticipated. Readers are urged to
consider these factors carefully in evaluating these
forward-looking statements, and not to place undue reliance on any
forward-looking statements, which speak only as of the date hereof
and reflect the views stated therein with respect to future events
as at such dates, even if they are subsequently made available by
Orchard on its website or otherwise. Readers should also carefully
review the risk factors described in other documents that Orchard
files from time to time with the SEC. Except as required by law,
Orchard assumes no obligation to update or revise these
forward-looking statements for any reason, even if new information
becomes available in the future.
No Offer or Solicitation
This communication is not intended to and shall
not constitute an offer to buy or sell or the solicitation of an
offer to buy or sell any securities, or a solicitation of any vote
or approval, nor shall there be any offer, solicitation or sale of
securities in any jurisdiction in which such offer, solicitation or
sale would be unlawful prior to registration or qualification under
the securities laws of any such jurisdiction. No offer of
securities shall be made in the United States absent registration
under the U.S. Securities Act of 1933, as amended, or pursuant to
an exemption from, or in a transaction not subject to, such
registration requirements.
Condensed Consolidated Statements of Operations Data(In
thousands, except share and per share
data)(Unaudited) |
|
|
|
Three Months Ended September 30, |
|
|
|
2023 |
|
|
2022 |
|
Product revenue, net |
|
$ |
5,559 |
|
|
$ |
5,377 |
|
Collaboration revenue |
|
|
743 |
|
|
|
400 |
|
Total revenue |
|
|
6,302 |
|
|
|
5,777 |
|
Costs and operating
expenses: |
|
|
|
|
|
|
Cost of product revenue |
|
|
1,745 |
|
|
|
1,645 |
|
Research and development |
|
|
14,553 |
|
|
|
18,103 |
|
Selling, general and administrative |
|
|
11,609 |
|
|
|
11,496 |
|
Total costs and operating expenses |
|
|
27,907 |
|
|
|
31,244 |
|
Loss from operations |
|
|
(21,605 |
) |
|
|
(25,467 |
) |
Other income (expense): |
|
|
|
|
|
|
Interest income |
|
|
1,505 |
|
|
|
404 |
|
Interest expense |
|
|
(932 |
) |
|
|
(799 |
) |
Changes in fair value of PIPE warrant and PIPE unit
liabilities |
|
|
(8,801 |
) |
|
|
— |
|
Other income (expense), net |
|
|
(4,510 |
) |
|
|
(22,787 |
) |
Total other income (expense), net |
|
|
(12,738 |
) |
|
|
(23,182 |
) |
Net loss before income
taxes |
|
|
(34,343 |
) |
|
|
(48,649 |
) |
Income tax benefit (expense) |
|
|
(976 |
) |
|
|
1,084 |
|
Net loss attributable to
ordinary shareholders |
|
$ |
(35,319 |
) |
|
$ |
(47,565 |
) |
Net loss per ordinary share,
basic and diluted |
|
$ |
(0.15 |
) |
|
$ |
(0.37 |
) |
Weighted average ordinary
shares outstanding, basic and diluted |
|
|
228,388,561 |
|
|
|
128,132,092 |
|
Condensed Consolidated Balance Sheet Data(In
thousands)(Unaudited) |
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2023 |
|
|
2022 |
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
23,469 |
|
|
$ |
68,424 |
|
Marketable securities |
|
|
101,944 |
|
|
|
75,326 |
|
Accounts receivable |
|
|
6,187 |
|
|
|
8,467 |
|
Inventory |
|
|
6,638 |
|
|
|
3,400 |
|
Prepaid expenses and other current assets |
|
|
7,451 |
|
|
|
6,586 |
|
Research and development tax credit receivable |
|
|
8,234 |
|
|
|
5,942 |
|
Total current assets |
|
|
153,923 |
|
|
|
168,145 |
|
Non-current assets: |
|
|
|
|
|
|
Operating lease right-of-use-assets |
|
|
20,001 |
|
|
|
22,774 |
|
Property and equipment, net |
|
|
7,131 |
|
|
|
8,138 |
|
Research and development tax credit receivable, net of current
portion |
|
|
3,372 |
|
|
|
— |
|
Restricted cash |
|
|
4,215 |
|
|
|
4,215 |
|
Intangible assets, net |
|
|
3,321 |
|
|
|
3,560 |
|
Other assets |
|
|
10,303 |
|
|
|
12,075 |
|
Total non-current assets |
|
|
48,343 |
|
|
|
50,762 |
|
Total assets |
|
$ |
202,266 |
|
|
$ |
218,907 |
|
Liabilities and
Shareholders’ Equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
3,661 |
|
|
$ |
9,318 |
|
Accrued expenses and other current liabilities |
|
|
29,995 |
|
|
|
34,437 |
|
Deferred revenue |
|
|
742 |
|
|
|
959 |
|
Operating lease liabilities |
|
|
5,548 |
|
|
|
6,424 |
|
Notes payable |
|
|
9,429 |
|
|
|
9,429 |
|
Total current liabilities |
|
|
49,375 |
|
|
|
60,567 |
|
Notes payable, long-term |
|
|
16,162 |
|
|
|
22,991 |
|
Deferred revenue, net of
current portion |
|
|
10,345 |
|
|
|
10,315 |
|
Operating lease liabilities,
net of current portion |
|
|
16,681 |
|
|
|
19,246 |
|
PIPE warrant liabilities |
|
|
21,068 |
|
|
|
— |
|
Other long-term
liabilities |
|
|
8,377 |
|
|
|
7,524 |
|
Total liabilities |
|
|
122,008 |
|
|
|
120,643 |
|
Total shareholders’
equity |
|
|
80,258 |
|
|
|
98,264 |
|
Total liabilities and shareholders’ equity |
|
$ |
202,266 |
|
|
$ |
218,907 |
|
Contact
Benjamin Navon
+1 857-248-9454
Benjamin.Navon@orchard-tx.com
Orchard Therapeutics (NASDAQ:ORTX)
過去 株価チャート
から 5 2024 まで 6 2024
Orchard Therapeutics (NASDAQ:ORTX)
過去 株価チャート
から 6 2023 まで 6 2024