On February 22, 2023 – Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported it will report its financial results for the fourth quarter of 2022 on Tuesday, February 28, 2023, before market open and subsequently host a webcast presentation at 4 p.m. CET / 10 a.m. ET (Press release, Nykode Therapeutics, FEB 22, 2023, View Source [SID1234627522]).

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A live and archived webcast of the presentation can be accessed in the Investors section of the Company’s website: View Source

On February 22, 2023 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies to replace and restore specific cell types of the human body, reported that it has entered into an exclusive option and license agreement (the "Agreement") with Eterna Therapeutics Inc. ("Eterna") for the development of novel beta 2 microglobulin (B2M)-deficient induced pluripotent stem cell (iPSC) lines, which Lineage will evaluate for development into differentiated cell transplant therapies (Press release, Lineage Cell Therapeutics, FEB 22, 2023, View Source [SID1234627521]). The new cell lines to be developed by Eterna will support the potential creation of additional product candidates at Lineage, specifically for the treatment of certain central nervous system (CNS) disorders and other neurology indications. Eterna is the exclusive licensee of the key intellectual property underlying this collaboration from its discovery partner Factor Bioscience.

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This press release features multimedia. View the full release here: View Source

"This agreement provides the opportunity to combine insights obtained from our dry age-related macular degeneration program with new tools, to broaden the scope of our technology and may help deliver solutions for a wider range of diseases. The engineering of desirable properties into cell lines can also lead to treatments that are highly differentiated from our competitors," stated Brian M. Culley, Lineage’s CEO. "The initial cell lines we envision bringing into the clinic through this agreement will utilize proprietary mRNA-based gene-editing technology developed by Eterna’s CEO, Dr. Matt Angel. It is natural that we would look to introduce aspects of gene editing, hypoimmunity, and additional pluripotent cell lines alongside our existing directed differentiation capabilities in the furtherance of our overall goal of becoming a comprehensive leader in cell therapy."

Under the Agreement, Eterna plans to conduct certain gene-editing activities and provide materials to Lineage for evaluation. The Agreement provides Lineage an option to obtain an exclusive license to utilize and sublicense the novel gene-edited cell lines for preclinical, clinical, and commercial purposes in the field of CNS diseases. A feature of the starting cell line is the targeted deletion of the B2M gene, which is designed to reduce the immunogenicity of product candidates derived from the lines by inhibiting rejection by CD8+ T cells. Lineage expects this attribute will expand the edited cell lines’ overall utility, including for non-immune privileged or non-human leukocyte antigen (HLA) matched indications. Additional planned gene edits may further differentiate the cell line from others currently in use by competitors. Financial terms were not disclosed.

"The cell therapy expertise demonstrated by Lineage makes them an attractive partner to deploy our mRNA cell engineering platform for the generation of novel gene-edited iPSC lines for neurological applications," said Matt Angel, Ph.D., CEO of Eterna. "At Eterna, we have expertise in creating gene-edited iPSC lines using our extensively patented mRNA cell engineering technologies. We look forward to collaborating with the Lineage team on this project and working with them to develop these powerful tools for the generation of new, intelligently-engineered cell therapy product candidates in the CNS space."

On February 22, 2023 Isofol Medical AB (publ), (Nasdaq Stockholm: ISOFOL), reported that the company’s year-end report for January – December 2022 is now available on the company’s website, www.isofolmedical.com (Press release, Isofol Medical, FEB 22, 2023, View Source [SID1234627519]).

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The information in the press release is intended for investors.

Fourth quarter, October – December 2022
Net revenue amounted to TSEK 1,857 (4,704) and other revenue to TSEK 57 (0)
The result for the period amounted to TSEK -25,335 (-61,170)
Earnings per share amounted to SEK -0.16 (-0.38)
Cash and cash equivalents on December 31 amounted to TSEK 190,583 (379,448)
January – December 2022
Net revenue amounted to TSEK 12,797 TSEK (22,407) and other revenue to TSEK 59 (0)
The result for the period amounted to TSEK -159,755 (-200,251)
Earnings per share amounted to SEK -0.99 (-1.59)
The Board of Directors proposes that no dividend will be paid for the 2022 financial year
Significant events during the fourth quarter 2022
On November 3 Isofol appointed its nomination committee ahead of the Annual General Meeting 2023 in accordance with the principles adopted at the Annual General Meeting on May 19, 2022.
On November 25 Isofol announced that the analysis of the AGENT study’s final data confirmed the negative topline results that were presented in August 2022. In addition, no predictive biomarkers for gene expression were identified for clinical response.
On November 28 Isofol announced that CEO Dr. Ulf Jungnelius MD would step down on June 1, 2023.
On December 21 Isofol announced that CFO and deputy CEO Gustaf Albèrt would leave the company during 2023.
Significant events after the event of the period
An extraordinary general meeting was held on February 13, 2023 to, in accordance with the board’s proposal, decide on an extra dividend and voluntary liquidation. However, the board’s proposal failed to reach the required voting majority and the resolution was therefore not adopted. As a consequence of the decision all members of the board of directors makes their postitions available and will not stand for re-election.
A written request for convening an extraordinary general meeting was received in January 2023 from shareholders with a total shareholding corresponding to more than 10 percent of the shares in the company to elect a new board. Notice of the extraordinary general meeting was sent out on February 3, 2023, and will be held on February 28, 2023.
CEO comment:
"During the quarter, we received final data that confirmed previous topline results, implicating that the objectives set together with the regulatory authorities for a market application for a new drug were not reached. In parallel, efforts to complete the closure of the AGENT study and measures to reduce costs have continued with high intensity. During January, the board proposed the company to be liquidated, however the proposal did not achieve the required majority. Given this, Isofol’s future will be decided in the first quarter of 2023," says CEO Ulf Jungnelius.

For more information, please contact
Isofol Medical AB (publ)
Ulf Jungnelius, M.D., CEO
E-mail: [email protected]
Telephone: +46 709-16 89 55

Gustaf Albèrt, CFO
E-mail: [email protected]
Telephone: +46 709-16 83 02

The information was submitted for publication, through the agency of the contact person set out above, at 08:00 CET, on February 22, 2023.

On February 22, 2023 Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) (the "Company"), a genetic medicines company,reported financial results for the fourth quarter and full year ended December 31, 2022 (Press release, Ionis Pharmaceuticals, FEB 22, 2023, View Source [SID1234627518]). Financial results are summarized below:

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Three months
ended
December 31,

Year ended
December 31,

2022

2021

2022

2021

(amounts in millions)

Total revenue

$
152

$
440

$
587

$
810

Operating expenses

$
360

$
219

$
998

$
840

Operating expenses on a non-GAAP basis

$
335

$
196

$
898

$
695

Net (loss) income

$
(52
)

$
225

$
(270
)

$
(29
)
Net (loss) income on a non-GAAP basis

$
(168
)

$
248

$
(311
)

$
116

Cash, cash equivalents and short-term investments1

$
1,987

$
2,115

1
Balance at December 31, 2022 does not include $500 million received in January 2023 under royalty monetization transaction.

Financial Highlights

•
2022 revenue was in line with expectations, reflecting revenue from numerous diverse sources. The prior year fourth quarter and full year benefited from the $200 million earned from AstraZeneca to jointly develop and commercialize eplontersen

•
2022 operating expenses increased as planned compared to the prior year, reflecting investments in pipeline, technology and go-to-market activities for eplontersen, olezarsen and donidalorsen

•
Further strengthened financial position with royalty monetization and sale and leaseback transactions worth up to $1.5 billion, including more than $700 million already received

•
Initiated construction of a new manufacturing facility to support Ionis’ goal to sustainably deliver genetic medicines to the market

1
Recent Late-Stage Pipeline Highlights

•
Submitted the eplontersen NDA in the U.S. for patients with polyneuropathy caused by hereditary TTR amyloidosis

•
FDA Advisory Committee meeting planned for March 22, 2023 to review Biogen’s NDA for tofersen for patients with SOD1-ALS (PDUFA date of April 25, 2023); EMA accepted MAA for review

•
FDA granted olezarsen Fast Track designation for the treatment of patients with FCS

•
Reported positive Phase 2 data from the open label extension study of donidalorsen in patients with hereditary angioedema treated for one year, including new data showing clinically meaningful improvement in angioedema quality of life score; Phase 3 study expected to complete enrollment in 2023

•
GSK advanced bepirovirsen into Phase 3 development in patients with chronic hepatitis B

Recent Additional Pipeline Highlights

•
Biogen initiated a Phase 2 study of IONIS-MAPTRx (BIIB080) in patients with mild cognitive impairment or mild dementia due to Alzheimer’s disease

•
Roche initiated a Phase 2 study of tominersen in patients with prodromal or early manifest Huntington’s disease

•
Biogen initiated a Phase 1 study of ION306 (BIIB115) for the treatment of spinal muscular atrophy with the potential for long interval dosing

Recent Technology Advancement Highlights

•
Partnered with Metagenomi to add gene editing capabilities to Ionis’ technology platform

•
Advanced programs incorporating muscle LICA technology and MsPA backbone chemistry into preclinical development

"We made substantial progress in 2022, marked by important achievements, including the December submission of the eplontersen NDA for people with ATTRv-PN. We also delivered multiple positive data readouts, enabling us to advance and expand our rich late- and mid-stage pipeline. And we took important steps to expand and diversify our technology, including our Metagenomi collaboration to add DNA editing to our platform," said Brett P. Monia, Ph.D., chief executive officer of Ionis. "As we start 2023, we are positioned to build upon our achievements by bringing our first near-term commercial opportunities to the market. We look forward to reporting the 66-week results from the eplontersen NEURO-TTRansform study in the first half of this year. Importantly, we are prepared to co-commercialization eplontersen with our partner, AstraZeneca. We also look forward to Phase 3 data from olezarsen in FCS patients, positioning us for our first independent launch. With the talent and resources we have today, we anticipate a highly productive year that will enable us to drive increasing value for all stakeholders."

2
Fourth Quarter and Full Year 2022 Financial Results

Revenue

Ionis’ revenue was comprised of the following:

Three months ended
December 31,

Year ended
December 31,

2022

2021

2022

2021

Revenue:

(amounts in millions)

Commercial revenue:

SPINRAZA royalties

$
67

$
69

$
242

$
268

TEGSEDI and WAYLIVRA revenue, net

7

9

30

56

Licensing and royalty revenue

6

9

31

18

Total commercial revenue

80

87

303

342

Research and development revenue:

Amortization from upfront payments

15

21

69

78

Milestone payments

14

40

74

88

License fees

–

290

37

291

Other services

22

2

27

11

Collaborative agreement revenue

51

353

207

468

Eplontersen joint development revenue

21

–

77

–

Total research and development revenue

72

353

284

468

Total revenue

$
152

$
440

$
587

$
810

Ionis’ 2022 revenue continued to be derived from diverse sources, with just over half coming from commercial products and the balance from numerous partnered programs. SPINRAZA royalties, the largest contributor to the Company’s commercial revenue, increased each quarter in 2022. Total SPINRAZA product sales increased six percent in the fourth quarter of 2022 compared to the prior quarter and also increased four percent compared to the same quarter in 2021. The increases were driven by stabilization in the U.S. and growth in Asian markets partially offset by competition in Europe. Total SPINRAZA product sales decreased six percent year-over-year due to foreign currency exchange and competition in Europe. TEGSEDI and WAYLIVRA revenue in 2022 reflected the shift to distribution fees.

R&D revenue for 2022 included $112 million from Biogen for advancing several neurology disease programs, $77 million from AstraZeneca for its share of the global Phase 3 development costs for eplontersen and $64 million from Roche for licensing and advancing IONIS-FB-LRx, among other partner payments. R&D revenue was higher in 2021 compared to 2022 primarily due to the $200 million Ionis earned in the fourth quarter of 2021 from AstraZeneca to jointly develop and commercialize eplontersen.

Operating Expenses

Ionis’ operating expenses increased for the three months and year ended December 31, 2022 compared to the same periods in 2021, in line with expectations. For both periods, higher R&D expenses were driven by the increased number of Phase 3 studies the Company is conducting, which doubled from three to six studies in 2021, and the $80 million upfront payment for Ionis’ collaboration with Metagenomi. SG&A expenses increased for the three months ended December 31, 2022 compared to the same period in 2021 driven by Ionis’ go-to-market activities for eplontersen, olezarsen and donidalorsen. SG&A expenses were lower for 2022 compared to 2021 largely due to the substantial savings the Company achieved from integrating Akcea and restructuring the Company’s commercial operations in 2021.

3
Gain on Sale of Property and Related Tax Impact

In October 2022, Ionis entered into a sale and leaseback transaction for several of its real estate assets. Under the agreement, Ionis received net proceeds of $200 million, with the potential to receive additional payments of up to $40 million plus funding to expand the Company’s R&D campus. As a result, the Company recognized a $150 million gain on sale of property and $9 million in related income tax expense in the fourth quarter of 2022. In conjunction with the sale and leaseback transaction, the Company extinguished its mortgage debt for the related properties and recorded a new right of lease asset and liability on its balance sheet.

Balance Sheet

As of December 31, 2022, Ionis had cash, cash equivalents and short-term investments of $2.0 billion compared to $2.1 billion at December 31, 2021. Ionis’ year-end cash balance does not include the $500 million the Company received from Royalty Pharma in January 2023. From December 31, 2021 to December 31, 2022, Ionis’ debt obligations decreased by $50 million because the Company repaid its mortgage debt and Ionis’ working capital decreased modestly driven by the Company’s slightly lower cash and short-term investments balance.

2023 Financial Guidance

The Company’s 2023 guidance reflects its ability to earn substantial revenue from its commercial portfolio and partnered programs. It also reflects the Company’s commitment to investing in advancing its rich late-stage pipeline and preparing to commercialize its near-term commercial opportunities, eplontersen, olezarsen and donidalorsen, while maintaining a healthy balance sheet to continue investing for future growth.

Full Year 2023 Guidance

Revenue
>$575 million
Operating expenses on a non-GAAP basis
~$970 – $995 million
Net operating loss on a non-GAAP basis
<$425 million
Cash, cash equivalents and short-term investments
~$2.0 billion

"Our solid 2022 financial results reflected our ability to earn substantial revenues while investing in key programs with the potential to drive substantial future growth, including our near-term commercial opportunities," said Elizabeth L. Hougen, chief financial officer of Ionis. "Additionally, we recently bolstered our balance sheet with more than $700 million from our royalty monetization and sale and leaseback transactions. With approximately $2.5 billion in pro forma cash, we have the resources to continue to advance our innovative pipeline and achieve commercial readiness for eplontersen, olezarsen and donidalorsen."

4
Webcast

Management will host a conference call and webcast to discuss Ionis’ fourth quarter and full year 2022 results at 11:30 a.m. Eastern time on Wednesday, February 22, 2022. Interested parties may access the webcast here. A webcast replay will be available for a limited time at the same address. To access the Company’s fourth quarter and full year 2022 earnings slides click here.

On February 22, 2023 Integra LifeSciences Holdings Corporation (NASDAQ: IART) reported financial results for the fourth quarter and full year ended December 31, 2022, consistent with its preliminary financial results reported on January 10, 2023 and January 25, 2023 (Press release, Integra LifeSciences, FEB 22, 2023, View Source [SID1234627517]).

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Fourth Quarter 2022

•Reported revenues were $398.0 million, representing a decrease of 1.8% on a reported basis and an increase of 2.9% on an organic basis compared to the fourth quarter 2021.

•GAAP earnings per diluted share were $0.63, compared to $0.53 in the fourth quarter 2021.

•Adjusted earnings per diluted share were $0.94, compared to $0.84 in the fourth quarter of 2021.

Full-Year 2022

•Reported revenues were 1,557.7 million representing an increase of 1.0% on a reported basis and an increase of 4.2% on an organic basis compared to full-year 2021.

•GAAP earnings per diluted share were $2.16, compared to $1.98 in 2021.

•Adjusted earnings per diluted share were $3.36, compared to $3.18 in 2021.

Key Accomplishments in 2022

•Advancing our portfolio:
▪Extended the CUSA Clarity portfolio with the launch of the laparoscopic and bone tips
▪Launched Aurora Evacuator plus coagulation in the U.S.
▪U.S. launch of NeuraGen 3D
▪Launched disposable instrument offering
▪International extension of Certas Plus valve line and entered into distribution agreement for Neutus external ventricular drain (EVD) in China

•Completed the ACell portfolio integration and executed the commercial capacity build-out

•Further refined the portfolio by divesting non-core traditional wound care business (TWC)

•Completed the acquisition of Surgical Innovation Associates, which develops, markets and sells DuraSorb, a resorbable mesh technology

•Completed strategic roadmap and M&A gameboard, including plans for international expansion

•Outsourced select global transactional back-office activities

•Closed a high-cost manufacturing facility in France

•Further strengthened executive leadership team with the appointment of the first chief digital officer and first executive vice president located outside the U.S.

•Developed sustainability baseline and strategy and published inaugural ESG report

• Named to Best Places to Work in NJ and Awarded Great Place to Work – Certified Organization in China

"We made key advances in strengthening our strategic path. We met our organic growth and exceeded our adjusted EPS guidance for the year. I am proud of our colleagues for being responsible stewards of our business in a challenging macro and supply environment. We remained focused on doing right by our customers and patients, while delivering on our financial commitments to our shareholders," said Jan De Witte, president and chief executive officer. "Looking to 2023, our efforts have positioned us well to further accelerate our growth and investments in our strategic priorities as we move beyond the impacts of COVID-19 and supply challenges."

Fourth Quarter 2022 Financial Summary

Total reported revenues for the fourth quarter were $398.0 million, a decrease of 1.8% from the fourth quarter of 2021. Fourth quarter organic revenues increased 2.9% over the prior year.

The Company reported GAAP net income of $52.9 million, or $0.63 per diluted share, in the fourth quarter of 2022, compared to GAAP net income of $45.4 million, or $0.53 per diluted share, in the prior year.

Adjusted EBITDA for the fourth quarter of 2022 was $109.7 million, compared to $105.4 million in the fourth quarter of the prior year. As a percentage of revenue, adjusted EBITDA was 27.6%, an increase of 160 basis points from the prior year period driven by careful OPEX management.

Adjusted net income for the fourth quarter of 2022 was $78.8 million, or $0.94 per diluted share, compared to adjusted net income of $72.2 million, or $0.84 per diluted share, in the fourth quarter of 2021.

Cash flows from operations totaled $85.3 million in the fourth quarter and capital expenditures were $14.5 million.

Fourth Quarter 2022 Segment Performance

•Codman Specialty Surgical (66% of Revenues)
◦Total revenues were $264.6 million, representing reported decrease of 2.2% and organic growth of 1.8% compared to the fourth quarter of 2021. Sales in Neurosurgery grew 1.7% on an organic basis driven by solid growth in CUSA capital and disposables in the US and global small capital sales offset by the recall impact of the CereLink monitors. Sales in Instruments grew 2.2% on an organic basis.

•Tissue Technologies (34% of Revenue)
◦Total revenues were $133.4 million, representing a decrease of 1.1% on a reported basis and organic growth of 5.0% compared to the fourth quarter of 2021. Organic growth in the segment was led by sales in Wound Reconstruction and Care, with broad strength from Integra Skin, amniotics, Primatrix MicroMatrix and Cytal, partially offset by an expected decline in private label.

Full-Year 2022 Financial Summary

Total reported revenues for the full-year 2022 were $1,557.7 million, an increase of 1.0%, from the prior year. Organic sales for the full-year 2022 increased 4.2% compared to 2021.

The Company reported GAAP net income of $180.6 million, or $2.16 per diluted share, for the full-year 2022, compared to GAAP net income of $169.1 million, or $1.98 per diluted share in 2021.

Adjusted EBITDA for the full-year 2022 was $411.3 million, an increase of $11.3 million over the prior year. Full year EBITDA margins were 26.4% an increase of 40 basis points from the prior year.

Adjusted net income for the full-year 2022 was $280.9 million, or $3.36 per diluted share, compared to $271.7 million, or $3.18 per diluted share.

2022 Balance Sheet, Cash Flow and Capital Allocation

The Company generated cash flow from operations of $264.5 million for the full-year 2022. Full-year capital expenditures were $42.3 million. Net debt at the end of the year was $1.0 billion, and the consolidated total leverage ratio was 2.2x. As of year-end, the Company had total liquidity of approximately $1.76 billion, including approximately $457 million in cash and the remainder available under its revolving credit facility.

2023 Revenue and Adjusted Earnings Per Share Guidance

The Company’s guidance for 2023 revenue and adjusted earnings per share reflects the recovery of our markets back to pre-COVID levels, a gradual improvement in supply over the year, the relaunch of CereLink in the first half, and the impact of our commercial capability build-out and new products. Our guidance also reflects the recent acquisition of DuraSorb as well as the divestiture of the TWC business.

For the full-year 2023, the Company expects revenues to be in a range of $1,602 million to $1,620 million, representing reported growth of approximately 2.9% to 4.0% and organic growth in the range of 4.0% to 5.2%. Adjusted earnings per diluted share are expected to be between $3.43 and $3.51.

Our guidance reflects a sequential improvement from first to second half growth primarily driven by the gradual recovery of supply throughout the year, 2022 normalization from our private label business, the recovery of our China business post-COVID lockdowns, and the timing of the CereLink relaunch. The acquisition of DuraSorb and divestiture of the TWC business also contributed to the sequential step-up in growth.

For the first quarter 2023, the Company expects reported revenues in the range of $370 million to $376 million, representing reported growth of approximately -1.5% to flat and organic growth of approximately 2.0% to 3.5%. Adjusted earnings per diluted share are expected to be in a range of $0.72 to $0.76.

Organic sales growth excludes acquisitions and divestitures as well as the effects of foreign currency and the year- over-year change in revenue from discontinued products.

The Company is providing forward-looking guidance regarding adjusted earnings per diluted share but is not providing a reconciliation to GAAP earnings per share, because certain GAAP expense items are highly variable, and management is unable to predict them with reasonable certainty and without unreasonable effort. Specifically, the financial impact and timing of divestitures, acquisitions, integrations, structural optimization and efforts to comply with the EU Medical Device Regulation are uncertain, depend on various dynamic factors and are not reasonably ascertainable at this time. These expense items could have a material impact on GAAP results. Adjusted earnings per diluted share also excludes the impact of intangible asset amortization associated with prior business acquisitions, which we expect to be approximately $0.80 per diluted share for the full-year 2023.

2023 Share Repurchase

On January 26, 2023, the Company entered into an accelerated share repurchase agreement with Goldman Sachs & Co. LLC to repurchase $150 million in the aggregate of the Company’s outstanding shares of common stock, par value $0.01 per share. The repurchase transactions are expected to be completed in the first half of 2023. The impact of the share repurchase is reflected in the 2023 adjusted earning per diluted share guidance range provided.

Conference Call and Presentation Available Online

Integra has scheduled a conference call for 8:30 a.m. ET on Wednesday, February 22, 2023, to discuss fourth quarter and full-year 2022 financial results, and forward-looking financial guidance. The conference call will be hosted by Integra’s senior management team and will be open to all listeners. Additional forward-looking information may be discussed in a question-and-answer session following the call. Integra’s management team will reference a presentation during the conference call, which can be found on the Investor Relations section of the website at investor.integralife.com.

A live webcast will be available on the Investors section of the Company’s website at investor.integralife.com. For those planning to participate on the call, please register here to receive dial-in details and a unique pin. While not required, it is recommended to join 10 minutes prior to the start of the event. A webcast replay of the conference call will be available on the Investor Relations section of the Company’s website following the call.