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Amneal Reports First Quarter 2024 Financial Results

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Amneal Reports First Quarter 2024 Financial Results




Amneal Reports First Quarter 2024 Financial Results

‒ Q1 2024 Net Revenue of $659 million; GAAP Net Loss of $92 million; Diluted Loss per Share of $0.30 ‒

‒ Adjusted EBITDA of $152 million; Adjusted Diluted EPS of $0.14 ‒

‒ Company has reached settlement in principle on a nationwide opioids settlement, payable over ten years ‒

‒ Affirming 2024 Full Year Guidance ‒

BRIDGEWATER, N.J.–(BUSINESS WIRE)–Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) announced its results today for the first quarter ended March 31, 2024.


“We are extremely pleased with our outstanding start to the year, as Amneal generated record levels of revenues in the first quarter. For the first time, all three segments across our diversified business produced double-digit top-line growth in the same quarter. With perpetual and rising demand for medicines and exacerbated by chronic supply shortages in the U.S. pharmaceutical industry, Amneal is part of the solution. As we become larger, we provide even more patients with access to high-quality, affordable, and essential medicines as we create value for all our stakeholders,” said Chirag and Chintu Patel, Co-Chief Executive Officers.

First Quarter 2024 Results

Net revenue in the first quarter of 2024 was $659 million, an increase of 18% compared to $558 million in the first quarter of 2023. Generics revenues increased 14% due to strong performance in complex generics, our oncology biosimilars and new launches. Specialty revenues increased 15% driven by promoted products in Neurology and Endocrinology. AvKARE revenues increased 33% driven by continued expansion across its channels due to new products.

Net loss attributable to Amneal Pharmaceuticals, Inc. was $92 million in the first quarter of 2024 compared to $7 million in the first quarter of 2023, and included a pre-tax charge of $94 million for settlement in principle on a nationwide opioids settlement.

Adjusted EBITDA in the first quarter of 2024 was $152 million, an increase of 31% compared to the first quarter of 2023, reflective of strong revenue performance and higher gross margins.

Diluted loss per share in the first quarter of 2024 was $0.30 compared to $0.05 for the first quarter of 2023 due to the aforementioned factors. Adjusted diluted earnings per share in the first quarter of 2024 was $0.14 compared to $0.12 for the first quarter of 2023.

The Company presents GAAP and adjusted (non-GAAP) quarterly results. Please refer to the “Non-GAAP Financial Measures” section for more information. In the tables below, GAAP to non-GAAP reconciliations are presented.

Settlement in Principle on a Nationwide Opioids Settlement

Amneal has reached a settlement in principle on the primary financial terms, with no admission of wrongdoing, for a nationwide resolution to the opioids cases that have been filed and that might have been filed against the Company by states, counties, municipalities, and Native American Tribal Nations across the United States. The settlement in principle resolves substantially all opioids litigation and is subject to the negotiation and execution of a definitive settlement agreement between the parties. The settlement would be payable over ten years. Under the settlement, the Company would agree to pay $92.5 million in cash and provide $180.0 million in naloxone nasal spray (valued at $125 per two-pack) to help treat opioid overdoses. In lieu of receiving product, the settling parties can opt to receive 25% of the product value (up to $45.0 million) in cash during the last four years of the ten-year payment term.

In the first quarter of 2024, the Company recorded a charge of $94 million in the consolidated statement of operations based on full participation in the potential settlement, which reflects the value of the cash payments and the supply of naloxone nasal spray over the ten-year period. The settlement in principle is contingent upon a sufficient number of settling parties electing to opt into the final definitive agreement. We remain committed to helping those impacted by the opioid crisis by enhancing access to naloxone nasal spray, which is an emergency treatment for opioid overdose and helps save lives.

Affirming Full Year 2024 Guidance

The Company is affirming its previously provided full year 2024 guidance.

Net revenue

$2.55 billion – $2.65 billion

Adjusted EBITDA (1)

$580 million – $620 million

Adjusted diluted EPS (2)

$0.53 – $0.63

Operating cash flow (3)

$260 million – $300 million

Capital expenditures

$60 million – $70 million

(1)

  

Includes 100% of Adjusted EBITDA from the AvKARE acquisition.

(2)

  

Accounts for 35% non-controlling interest in AvKARE. Assumes weighted-average diluted shares outstanding of approximately 317 million for the year ending December 31, 2024.

(3)

  

Does not contemplate one-time and non-recurring items such as legal settlements and other discrete items.

Amneal’s 2024 estimates are based on management’s current expectations, including with respect to prescription trends, pricing levels, the timing of future product launches, the costs incurred and benefits realized of restructuring activities, and our long-term strategy. The Company’s financial statements are prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”). The Company cannot provide a reconciliation between non-GAAP projections and the most directly comparable measures in accordance with GAAP without unreasonable efforts because it is unable to predict with reasonable certainty the ultimate outcome of certain significant items required for the reconciliation. The items include, but are not limited to, acquisition-related expenses, restructuring expenses and benefits, asset impairments, legal settlements, and other gains and losses. These items are uncertain, depend on various factors, and could have a material impact on GAAP reported results.

Conference Call Information

Amneal will host a conference call and live webcast at 8:30 am Eastern Time today, May 3, 2024, to discuss its results. The live webcast and presentation will be accessible through the Investor Relations section of the Company’s website at https://investors.amneal.com. To access the call through a conference line, dial (833) 470-1428 (in the U.S.) with access code 172198. A replay of the conference call will be posted shortly after the call and will be available for seven days. For a list of toll-free international numbers, visit this website: https://www.netroadshow.com/events/global-numbers?confId=52762.

About Amneal

Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global pharmaceuticals company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 generic and specialty pharmaceuticals, primarily within the United States. In its Generics segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit www.amneal.com.

Cautionary Statement on Forward-Looking Statements

Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements.

The reader is cautioned not to rely on these forward-looking statements. These forward-looking statements are based on current expectations of future events, including with respect to future market conditions, company performance and financial results, operational investments, business prospects, new strategies and growth initiatives, the competitive environment, and other events. If the underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Company.

Such risks and uncertainties include, but are not limited to: our ability to successfully develop, license, acquire and commercialize new products on a timely basis; the competition we face in the pharmaceutical industry from brand and generic drug product companies, and the impact of that competition on our ability to set prices; our ability to obtain exclusive marketing rights for our products; our revenues are derived from the sales of a limited number of products, a substantial portion of which are through a limited number of customers; the impact of a prolonged business interruption within our supply chain; the continuing trend of consolidation of certain customer groups; our dependence on third-party suppliers and distributors for raw materials for our products and certain finished goods; legal, regulatory and legislative efforts by our brand competitors to deter competition from our generic alternatives; our dependence on information technology systems and infrastructure and the potential for cybersecurity incidents; our ability to attract, hire and retain highly skilled personnel; risks related to federal regulation of arrangements between manufacturers of branded and generic products; our reliance on certain licenses to proprietary technologies from time to time; the significant amount of resources we expend on research and development; the risk of claims brought against us by third parties; risks related to changes in the regulatory environment, including U.S. federal and state laws related to healthcare fraud abuse and health information privacy and security and changes in such laws; changes to Food and Drug Administration product approval requirements; the impact of healthcare reform and changes in coverage and reimbursement levels by governmental authorities and other third-party payers; our dependence on third-party agreements for a portion of our product offerings; our substantial amount of indebtedness and our ability to generate sufficient cash to service our indebtedness in the future, and the impact of interest rate fluctuations on such indebtedness; our potential expansion into additional international markets subjecting us to increased regulatory, economic, social and political uncertainties; our ability to identify, make and integrate acquisitions or investments in complementary businesses and products on advantageous terms; the impact of global economic, political or other catastrophic events; our obligations under a tax receivable agreement may be significant; and the high concentration of ownership of our Class A common stock and the fact that we are controlled by the Amneal Group. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Investors are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.

Non-GAAP Financial Measures

This release includes certain non-GAAP financial measures, including EBITDA, adjusted EBITDA, adjusted net income and adjusted diluted EPS, which are intended as supplemental measures of the Company’s performance that are not required by or presented in accordance with GAAP. Adjusted diluted EPS reflects diluted earnings per share based on adjusted net income, which is net loss adjusted to (A) exclude (i) non-cash interest, (ii) GAAP provision for income taxes, (iii) amortization, (iv) stock-based compensation, (v) acquisition, site closure expenses, and idle facility expenses, (vi) restructuring and other charges, (vii) charges related to certain legal matters, including interest, net, (viii) asset impairment charges, (ix) change in fair value of contingent consideration, (x) increase in tax receivable agreement liability, (xi) system implementation expense, (xii) other and (xiii) net income attributable to non-controlling interests not associated with Class B common stock, and (B) include non-GAAP provision for income taxes. Non-GAAP adjusted diluted EPS for the three months ended March 31, 2024 was calculated using the weighted average fully diluted shares outstanding of Class A common stock. Non-GAAP adjusted diluted EPS for the three months ended March 31, 2023 was calculated using the weighted average diluted shares outstanding of Class A common stock and assuming all shares of Class B common stock were converted to shares of Class A common stock as of January 1, 2023.

Management uses these non-GAAP measures internally to evaluate and manage the Company’s operations and to better understand its business because they facilitate a comparative assessment of the Company’s operating performance relative to its performance based on results calculated under GAAP. These non-GAAP measures also isolate the effects of some items that vary from period to period without any correlation to core operating performance and eliminate certain charges that management believes do not reflect the Company’s operations and underlying operational performance. The compensation committee of the Company’s board of directors also uses certain of these measures to evaluate management’s performance and set its compensation. The Company believes that these non-GAAP measures also provide useful information to investors regarding certain financial and business trends relating to the Company’s financial condition and operating results facilitates an evaluation of the financial performance of the Company and its operations on a consistent basis. Providing this information therefore allows investors to make independent assessments of the Company’s financial performance, results of operations and trends while viewing the information through the eyes of management.

These non-GAAP measures are subject to limitations. The non-GAAP measures presented in this release may not be comparable to similarly titled measures used by other companies because other companies may not calculate one or more in the same manner. Additionally, the non-GAAP performance measures exclude significant expenses and income that are required by GAAP to be recorded in the Company’s financial statements; do not reflect changes in, or cash requirements for, working capital needs; and do not reflect interest expense, or the requirements necessary to service interest or principal payments on debt. Further, our historical adjusted results are not intended to project our adjusted results of operations or financial position for any future period. To compensate for these limitations, management presents and considers these non-GAAP measures in conjunction with the Company’s GAAP results; no non-GAAP measure should be considered in isolation from or as alternatives to any measure determined in accordance with GAAP. Readers should review the reconciliations included below, and should not rely on any single financial measure to evaluate the Company’s business.

A reconciliation of each historical non-GAAP measure to the most directly comparable GAAP measure is set forth below.

Amneal Pharmaceuticals, Inc.

Consolidated Statements of Operations

(unaudited; $ in thousands, except per share amounts)

 

Three Months Ended March 31,

 

 

2024

 

 

 

2023

 

Net revenue

$

659,191

 

 

$

557,540

 

Cost of goods sold

 

421,131

 

 

 

379,354

 

Gross profit

 

238,060

 

 

 

178,186

 

Selling, general and administrative

 

112,595

 

 

 

102,096

 

Research and development

 

39,298

 

 

 

38,690

 

Intellectual property legal development expenses

 

984

 

 

 

1,644

 

Restructuring and other charges

 

1,470

 

 

 

510

 

Change in fair value of contingent consideration

 

100

 

 

 

2,457

 

Charges (credit) related to legal matters, net

 

94,359

 

 

 

(436

)

Other operating income

 

—

 

 

 

(1,224

)

Operating (loss) income

 

(10,746

)

 

 

34,449

 

Other (expense) income:

 

 

 

Interest expense, net

 

(65,703

)

 

 

(49,315

)

Foreign exchange (loss) gain, net

 

(1,197

)

 

 

1,901

 

Increase in tax receivable agreement liability

 

(1,948

)

 

 

(826

)

Other income, net

 

4,072

 

 

 

4,365

 

Total other expense, net

 

(64,776

)

 

 

(43,875

)

Loss before income taxes

 

(75,522

)

 

 

(9,426

)

Provision for income taxes

 

6,156

 

 

 

668

 

Net loss

 

(81,678

)

 

 

(10,094

)

Less: Net (income) loss attributable to non-controlling interests

 

(9,965

)

 

 

3,151

 

Net loss attributable to Amneal Pharmaceuticals, Inc.

$

(91,643

)

 

$

(6,943

)

 

 

 

 

Net loss per share attributable to Amneal Pharmaceuticals, Inc.’s Class A common stockholders:

 

 

 

Basic and diluted 

$

(0.30

)

 

$

(0.05

)

Weighted-average common shares outstanding:

 

 

 

Basic and diluted 

 

307,279

 

 

 

152,109

 

Amneal Pharmaceuticals, Inc.

Condensed Consolidated Balance Sheets

(unaudited; $ in thousands)

 

March 31, 2024

 

December 31, 2023

Assets

 

 

 

Current assets:

 

 

 

Cash and cash equivalents

$

46,520

 

 

$

91,542

Restricted cash

 

5,097

 

 

 

7,565

Trade accounts receivable, net

 

668,955

 

 

 

613,732

Inventories

 

570,653

 

 

 

581,384

Prepaid expenses and other current assets

 

87,298

 

 

 

82,685

Related party receivables

 

1,521

 

 

 

955

Total current assets

 

1,380,044

 

 

 

1,377,863

Property, plant and equipment, net

 

439,815

 

 

 

447,574

Goodwill

 

598,549

 

 

 

598,629

Intangible assets, net

 

859,272

 

 

 

890,423

Operating lease right-of-use assets

 

32,970

 

 

 

30,329

Operating lease right-of-use assets – related party

 

12,468

 

 

 

12,954

Financing lease right-of-use assets

 

59,532

 

 

 

59,280

Other assets

 

73,747

 

 

 

55,517

Total assets

$

3,456,397

 

 

$

3,472,569

Liabilities and Stockholders’ (Deficiency) Equity

 

 

 

Current liabilities:

 

 

 

Accounts payable and accrued expenses

$

558,518

 

 

$

534,662

Current portion of liabilities for legal matters

 

30,130

 

 

 

76,988

Revolving credit facility

 

179,000

 

 

 

179,000

Current portion of long-term debt, net

 

33,660

 

 

 

34,125

Current portion of operating lease liabilities

 

9,508

 

 

 

9,207

Current portion of operating lease liabilities – related party

 

3,192

 

 

 

2,825

Current portion of financing lease liabilities

 

3,305

 

 

 

2,467

Related party payables – short term

 

17,075

 

 

 

7,321

Total current liabilities

 

834,388

 

 

 

846,595

Long-term debt, net

 

2,377,707

 

 

 

2,386,004

Note payable – related party

 

41,893

 

 

 

41,447

Operating lease liabilities

 

26,786

 

 

 

24,095

Operating lease liabilities – related party

 

11,969

 

 

 

12,787

Financing lease liabilities

 

58,809

 

 

 

58,566

Related party payables – long term

 

11,394

 

 

 

11,776

Liabilities for legal matters – long term

 

85,479

 

 

 

316

Other long-term liabilities

 

24,579

 

 

 

29,679

Total long-term liabilities

 

2,638,616

 

 

 

2,564,670

Redeemable non-controlling interests

 

47,022

 

 

 

41,293

Total stockholders’ (deficiency) equity

 

(63,629

)

 

 

20,011

Total liabilities and stockholders’ (deficiency) equity

$

3,456,397

 

 

$

3,472,569

Amneal Pharmaceuticals, Inc.

Consolidated Statements of Cash Flows

(unaudited; $ in thousands)

 

Three Months Ended March 31,

 

 

2024

 

 

 

2023

 

Cash flows from operating activities:

 

 

 

Net loss

$

(81,678

)

 

$

(10,094

)

Adjustments to reconcile net loss to net cash (used in) provided by operating activities:

 

 

 

Depreciation and amortization

 

55,528

 

 

 

58,150

 

Unrealized foreign currency loss (gain)

 

1,511

 

 

 

(1,987

)

Amortization of debt issuance costs and discount

 

288

 

 

 

2,058

 

Intangible asset impairment charges

 

920

 

 

 

—

 

Change in fair value of contingent consideration

 

100

 

 

 

2,457

 

Stock-based compensation

 

6,722

 

 

 

7,596

 

Inventory provision

 

22,923

 

 

 

25,204

 

Other operating charges and credits, net

 

1,250

 

 

 

2,047

 

Changes in assets and liabilities:

 

 

 

Trade accounts receivable, net

 

(55,173

)

 

 

195,970

 

Inventories

 

(12,200

)

 

 

(22,508

)

Prepaid expenses, other current assets and other assets

 

(11,708

)

 

 

29,160

 

Related party receivables

 

(562

)

 

 

470

 

Accounts payable, accrued expenses and other liabilities

 

62,174

 

 

 

(150,483

)

Related party payables

 

5,495

 

 

 

1,672

 

Net cash (used in) provided by operating activities

 

(4,410

)

 

 

139,712

 

Cash flows from investing activities:

 

 

 

Purchases of property, plant and equipment

 

(9,198

)

 

 

(9,688

)

Acquisition of intangible assets

 

(9,700

)

 

 

(338

)

Deposits for future acquisition of property, plant and equipment

 

(862

)

 

 

(1,711

)

Net cash used in investing activities

 

(19,760

)

 

 

(11,737

)

Cash flows from financing activities:

 

 

 

Payments of principal on debt, revolving credit facilities, financing leases and other

 

(63,377

)

 

 

(72,659

)

Borrowings on revolving credit facilities

 

48,000

 

 

 

80,000

 

Proceeds from exercise of stock options

 

28

 

 

 

—

 

Employee payroll tax withholding on restricted stock unit vesting

 

(7,212

)

 

 

(2,022

)

Tax distributions to non-controlling interests

 

(594

)

 

 

(18,219

)

Net cash used in financing activities

 

(23,155

)

 

 

(12,900

)

Effect of foreign exchange rate on cash

 

(165

)

 

 

767

 

Net (decrease) increase in cash, cash equivalents, and restricted cash

 

(47,490

)

 

 

115,842

 

Cash, cash equivalents, and restricted cash – beginning of period

 

99,107

 

 

 

35,227

 

Cash, cash equivalents, and restricted cash – end of period

$

51,617

 

 

$

151,069

 

Cash and cash equivalents – end of period

$

46,520

 

 

$

144,674

 

Restricted cash – end of period

 

5,097

 

 

 

6,395

 

Cash, cash equivalents, and restricted cash – end of period

$

51,617

 

 

$

151,069

 

Amneal Pharmaceuticals, Inc.

Non-GAAP Reconciliations

(unaudited, $ in thousands)

Reconciliation of Net Loss to EBITDA and Adjusted EBITDA

 

Three Months Ended March 31,

 

 

2024

 

 

 

2023

 

Net loss

$

(81,678

)

 

$

(10,094

)

Adjusted to add:

 

 

 

Interest expense, net

 

65,703

 

 

 

49,315

 

Provision for income taxes

 

6,156

 

 

 

668

 

Depreciation and amortization

 

55,528

 

 

 

58,150

 

EBITDA (Non-GAAP)

$

45,709

 

 

$

98,039

 

Adjusted to add (deduct):

 

 

 

Stock-based compensation expense

 

6,506

 

 

 

7,596

 

Acquisition, site closure, and idle facility expenses (1)

 

444

 

 

 

2,701

 

Restructuring and other charges

 

1,470

 

 

 

411

 

Charges related to legal matters, net (2)

 

94,359

 

 

 

4,064

 

Asset impairment charges

 

1,015

 

 

 

733

 

Foreign exchange loss (gain)

 

1,197

 

 

 

(1,901

)

Change in fair value of contingent consideration

 

100

 

 

 

2,457

 

Increase in tax receivable agreement liability

 

1,948

 

 

 

826

 

System implementation expense (3)

 

917

 

 

 

771

 

Other

 

(1,314

)

 

 

483

 

Adjusted EBITDA (Non-GAAP)

$

152,351

 

 

$

116,180

 

Contacts

Anthony DiMeo

VP, Investor Relations & Media

anthony.dimeo@amneal.com

Read full story here

PCI Biotech Holding ASA – Notice of Annual General Meeting 2024

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PCI Biotech Holding ASA – Notice of Annual General Meeting 2024




PCI Biotech Holding ASA – Notice of Annual General Meeting 2024

Oslo, Norway 3 May 2024 – The annual general meeting of PCI Biotech Holding ASA will be held at the company’s office at Oslo Cancer Cluster Innovation Park, on 24 May 2024 at 10:00am (CEST).

The notice and proposed resolutions to the annual general meeting are attached. The notice, including all appendices, will be made available at PCI Biotech’s corporate website www.pcibiotech.com.

For further information, please contact:
Ronny Skuggedal, CEO/CFO, E-mail: rs@pcibiotech.no
Office: +47 67 11 54 00 Mobile: +47 94 00 57 57

This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.

Attachments

AAVantgarde announces its innovative clinical study design for its lead program in Usher 1B

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AAVantgarde announces its innovative clinical study design for its lead program in Usher 1B




AAVantgarde announces its innovative clinical study design for its lead program in Usher 1B

MILAN, Italy, May 03, 2024 (GLOBE NEWSWIRE) — AAVantgarde Bio (AAVantgarde), a clinical-stage, Italian-based international biotechnology company with two proprietary Adeno-Associated Viral (AAV) vector platforms for large gene delivery, today announced the presentation of the clinical trial design of the Company’s lead program in Usher 1B by the program’s Principal Investigator, Prof. Francesca Simonelli, at the 9th Annual Retinal Cell and Gene Therapy Innovation Summit, being held today in Seattle.

The LUCE-1 clinical study is a first-in-human Phase 1/2 clinical study designed in collaboration with Prof. Simonelli and other leading experts in the field. Leveraging AAVantgarde’s proprietary Dual Hybrid platform, this study aims to provide robust evidence supporting the effectiveness and safety profile of the Company’s lead program, AAVB-081, that addresses the retinitis pigmentosa derived from MYO7A-related Usher syndrome (USH1B).

“I am delighted to be presenting the pre-clinical and clinical activities that paved the way to the design of this first-in-human Phase 1/2 clinical study at the Summit. Through this innovative design, we aim to revolutionize our approach to understanding and treating Usher 1B patients. We are poised to generate robust evidence that will not only advance scientific knowledge, but also directly impact patient care,” said Prof. Francesca Simonelli, Head of Ophthalmology at the University of Campania Luigi Vanvitelli (Naples).

Dr. Natalia Misciattelli, CEO of AAVantgarde added “We are honoured to have Prof. Simonelli as Principal Investigator for this first in human Phase 1/2 clinical study aimed at providing hope for underserved USH1B patients that have no therapeutic options to prevent them from losing their sight. Prof. Simonelli is a pioneer in gene therapy in ophthalmology and her valuable experience in this space will greatly help us to the successful development of this novel therapy.”

Presentation details:

Title: Design of a Phase 1/2 clinical trial using a dual vector strategy for the treatment of MYOA7-related Usher syndrome (USH1B)

Session Title: Session 2 – Pre-clinical Gene Therapy

Date/Time: May 3, 2024 from 9:35 AM to 9.50 AM PDT

About AAVantgarde Bio
AAVantgarde Bio is a clinical stage, Italian headquartered, international biotechnology company that has developed two proprietary Adeno-Associated Viral (AAV) vector platforms to address the gene therapy cargo capacity limitations of AAV vectors. The AAVantgarde platforms could be used to deliver large genes to ocular and non-ocular tissues. Co-founded by Professor Alberto Auricchio at TIGEM (Telethon Institute of Genetics and Medicine) in Naples, Italy, and Telethon Foundation, AAVantgarde will initially validate the platform in the clinic in two inherited retinal diseases with clear unmet need. For more information, please visit: www.aavantgarde.com

Contact:
Magda Blanco – Head of Corporate Development AAVantgarde
Email: m.blanco@aavantgarde.com

Nexstim, Inc. and Inomed Inc. Enter into Strategic Alliance Agreement for US Market

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Nexstim, Inc. and Inomed Inc. Enter into Strategic Alliance Agreement for US Market




Nexstim, Inc. and Inomed Inc. Enter into Strategic Alliance Agreement for US Market

Press release, Helsinki, 3 May 2024, 10 AM (EEST)

Nexstim, Inc. and Inomed Inc. Enter into Strategic Alliance Agreement for US Market

Nexstim Plc (NXTMH:HEX) (“Nexstim” or “Company”) announces that Nexstim, Inc. has signed a non-exclusive strategic alliance agreement with Inomed Inc. for the purpose of strengthening the collaboration of Marketing, Sales, and Application Support between both companies in the United States.

Both Nexstim and Inomed will attend the American Association of Neurological Surgeons (AANS) Annual Scientific Meeting in Chicago, IL this week, where both companies will present their products and service offerings to leading neurosurgeons from the US and around the world. Nexstim team can be found at booth no. 721 and Inomed at booth no. 914.

In addition, Nexstim invites all those interested in nTMS brain mapping to a Lunch and Learn event held at the AANS Meeting on Saturday May 4, 2024 at 12:30 pm at B1 # 1343. The Lunch and Learn will be covering recent advancements in non-invasive brain mapping with Profs. Hugues Duffau, Sujit Prabhu and Sandro Krieg. Admission is free, but as seats tend to go quickly, we advise attendees to arrive early. Lunch will be provided.

Further information is available on the website www.nexstim.com, or by contacting:

Mikko Karvinen, CEO
+358 50 326 4101
mikko.karvinen@nexstim.com

About Nexstim Plc

Nexstim is a Finnish, globally operating growth-oriented medical technology company. Our mission is to enable personalized and effective diagnostics and therapies for challenging brain diseases and disorders.

Nexstim has developed a world-leading non-invasive brain stimulation technology for navigated transcranial magnetic stimulation (nTMS) with highly sophisticated 3D navigation providing accurate and personalized targeting of the TMS to the specific area of the brain.

Nexstim’s Diagnostics Business focuses on commercialization of the Navigated Brain Stimulation (NBS) system. The NBS System 5 is the only FDA cleared and CE marked navigated TMS system for pre-surgical mapping of the speech and motor cortices of the brain.

Nexstim’s Therapy Business markets and sells the NBS System 6 which is FDA cleared for marketing and commercial distribution for the treatment of major depressive disorder (MDD) in the United States. In Europe, the NBS 6 system is CE marked for the treatment of major depression and chronic neuropathic pain.

Nexstim shares are listed on Nasdaq First North Growth Market Finland.

For more information, please visit www.nexstim.com

About Inomed

Inomed is a leading medical device manufacturer, developing sophisticated products for neuro-diagnostics, neurosurgical interventions and related therapies. The origins of Inomed lay in intraoperative monitoring of neurological function and the company has been recognized by the “Top 100” Society as one of the most innovative medium-sized German companies, engaging in research partnerships with universities and specialized institutes.

Headquartered in Emmendingen, near the city of Freiburg-Breisgau in Germany, Inomed employs more than 400 people worldwide, including a research and development department with subject matter experts from the fields of biology, medicine, informatics, mechanical engineering and the humanities, working together with medical experts from hospitals, clinics and other research partners. Inomed’s ultimate goal is to provide the most effective tools to the clinician, thereby improving outcomes and helping to enhance quality of life for patients.

More information available at https://www.en.inomed.com/.

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Q1 update: Novonesis delivers 4% organic sales growth in line with expectations and reports progress on the integration

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Q1 update: Novonesis delivers 4% organic sales growth in line with expectations and reports progress on the integration




Q1 update: Novonesis delivers 4% organic sales growth in line with expectations and reports progress on the integration

For the first quarter as Novonesis, the company delivers 4% organic sales growth in line with expectations. Novonesis maintains the 2024 outlook of 5-7% organic sales growth with an adjusted EBITDA margin of around 35%.

COPENHAGEN, Denmark – May 3, 2024. In the first three months of the 2024 financial year, Novonesis delivers 4% organic sales growth against a strong comparator. The organic sales growth in the first quarter is driven by both Food & Health Biosolutions and Planetary Health Biosolutions. Overall, volumes increased by around 2% and pricing contributed around 2%.

“We are off to a good start. With 4% organic sales growth, we deliver in line with expectations for the first three months, and we continue to successfully move forward on the integration. Being in a place of comfort, we are already seeing synergies from bringing the two great legacy companies together, and we are fully focused on both short and long-term deliverables and developments. I am proud and thankful to see the determination and focus of the entire organization,” says Ester Baiget, President & CEO, and continues: 

“Following the good start to the year, we are comfortable in maintaining the full-year 2024 outlook for both organic sales growth and profitability. Our biosolutions are more relevant than ever, and now we will further accelerate growth and develop transformative innovations.”

Growth driven by both Food & Health Biosolutions and Planetary Health Biosolutions

In the first three months of the year, Food & Health Biosolutions grew 3% organically, while Planetary Health grew 5% organically. In Food & Health Biosolutions, Food & Beverages grew 6% organically, while Human Health declined 5% in line with expectations. Food & Beverages was driven by strong growth in Dairy and solid growth in Baking. As expected, Human Health had a soft start to the year due to a strong comparator and order timing in both HMO and Dietary supplements. In Planetary Health Biosolutions, Household Care grew 15% organically with growth across all regions. Agriculture, Energy & Tech was flat with double-digit growth in Energy and a demanding comparator in Agriculture.

For Q1 2024, organic growth rates by business area were 6% in Food & Beverages, -5% in Human Health, 15% in Household Care, and 0% in Agriculture, Energy & Tech.

Double-digit growth across all sales areas in emerging markets

In the first quarter, emerging markets grew 14% organically, while developed markets declined 1%. In emerging markets, the organic sales growth was driven by double-digit growth across all sales areas. The decline in organic sales growth in developed markets was driven by a decline in Human Health and soft performance in Agriculture, Energy & Tech and partly offset by growth in Household Care and Food & Beverages.

For Q1 2024, organic growth rates by geography were 2% in Europe, Middle East & Africa, -1% in North America, 13% in Asia Pacific, and 10% in Latin America.

Financial outlook for 2024
Novonesis maintains its sales and profitability outlook for 2024 with pro forma organic sales growth of 5-7% and a pro forma adjusted EBITDA margin at ~35%. Food & Health Biosolutions is indicated to grow organically in the mid-to-high single digits and Planetary Health Biosolutions is indicated to grow mid-single digit. Growth in Food & Beverages is expected to be driven by broad performance across subareas. Growth in Human Health is expected to be driven by sales of Advanced Protein Solutions to the anchor customer as well as by Dietary Supplements. Household Care is expected to be driven by increased penetration across markets. Agriculture, Energy & Tech is expected to be driven by growth across all subareas led by Energy.

All organic sales growths numbers are calculated on a pro forma basis including three months of both legacy Novozymes and legacy Chr. Hansen sales.

Financial calendar 2024

  • June 18, 2024: Capital Markets Day in London
  • August 28, 2024: H1 announcement 2024
  • November 7, 2024: Trading statement 9M 2024

Media Relations   Investor Relations
Lina Danstrup 
Head of External Communication
Phone: +45 30 77 05 52
lind@novonesis.com 		  Tobias Cornelius Björklund
Head of Investor Relations
Phone: +45 30 77 86 82
tobb@novonesis.com

Attachments

Trading statement Q1 2024

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Trading statement Q1 2024




Trading statement Q1 2024

Novonesis realized 4% organic sales growth in line with expectations and maintains 2024 outlook.

Ester Baiget, President & CEO: “I am pleased with the first quarter organic sales growth of 4% with growth in both Food & Health and Planetary Health. We are off to a good start in line with expectations and very well on track to deliver 5-7% organic sales growth for the full year with an adjusted EBITDA margin of around 35%. It’s highly comforting to see our new organization’s focus on both short and long-term deliverables and developments.”

Pro forma sales performance¹ (organic sales growth calculation capped for hyperinflation countries)
Against a strong comparable Novonesis realized 4% pro forma organic sales growth in Q1 2024. Volumes increased by around 2% and pricing also contributed around 2%. Pro forma sales in EUR amounted to 965.5 million, an increase of 1% (organic +4%, currency -2%, M&A -1%). Emerging markets grew 14% organically, while developed markets declined 1%.

  • Food & Health Biosolutions realized pro forma organic sales growth of 3% for Q1 2024. Pro forma sales in EUR were 424.8 million, a decrease of 2% (organic +3%, currency -2%, M&A -3%). The divestment relates to the lactase enzyme business. Food & Beverages grew 6% organically, while Human Health declined 5%, in line with expectations. Food & Beverages was driven by strong growth in Dairy and solid growth in Baking. As expected, Human Health had a soft start to the year due to a strong comparable and order timing in both HMO and Dietary supplements.
  • Planetary Health Biosolutions realized pro forma organic sales growth of 5% for Q1 2024. Pro forma sales in EUR were 540.7 million, an increase of 3% (organic +5%, currency -2%). Household Care grew 15% organically with growth across all regions. Agriculture, Energy & Tech was flat with double-digit growth in Energy and a demanding comparable in Agriculture.

Reported (IFRS) sales performance (Chr. Hansen included as of January 29, 2024)
Novonesis reported 4% organic sales growth according to IFRS reporting. Reported sales in EUR were 853.5 million (Q1 2023: EUR 621.1 million). Please see Appendix 2 for further details.

2024 outlook¹
Novonesis maintains its sales and profitability outlook for 2024 with pro forma organic sales growth of 5-7% and a pro forma adjusted EBITDA margin at ~35%. Food & Health Biosolutions is indicated to grow organically in the mid-to-high single digits and Planetary Health Biosolutions is indicated to grow mid-single digit. Growth in Food & Beverages is expected to be driven by broad performance across subareas. Growth in Human Health is expected to be driven by sales of Advanced Protein Solutions to the anchor customer as well as by Dietary Supplements. Household Care is expected to be driven by increased penetration across markets. Agriculture, Energy & Tech is expected to be driven by growth across all subareas led by Energy.

¹The outlook 2024 is based on 12 months pro forma numbers for the consolidated business. The 2024 IFRS reported numbers are expected to be similar, i.e. same outlook. Refer to Company Announcement no. 11 – March 21, 2024 for further details.

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Sun Nuclear Showcases New Quality Management Solutions for Radiation Therapy Teams and Workflows at ESTRO Annual Meeting

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Sun Nuclear Showcases New Quality Management Solutions for Radiation Therapy Teams and Workflows at ESTRO Annual Meeting




Sun Nuclear Showcases New Quality Management Solutions for Radiation Therapy Teams and Workflows at ESTRO Annual Meeting

SunCHECK® Software Version 5.0, Innovations Across the Portfolio, and Solutions from Mirion

MELBOURNE, Fla.–(BUSINESS WIRE)–Sun Nuclear, a Mirion Medical company, will feature new and enhanced solutions for better Quality Management at the ESTRO Annual Meeting, May 3-6, in Glasgow, Scotland. The Sun Nuclear booth (#930) will highlight demonstrations and insights on the recently announced Version 5.0 of the SunCHECK® Platform, as well as advancements to the comprehensive Sun Nuclear quality management portfolio and products from other Mirion brands supporting the field of cancer care.


This year’s ESTRO Annual Meeting theme, Bridging the Care gap, focuses on how the field can collectively “bridge gaps in provision of providing optimal radiotherapy to all.” To that end, Sun Nuclear will highlight solutions that improve workflow efficiency, deliver earlier critical insights on treatment quality, and enable proactive delivery system quality assessment. Collectively, these expanded solutions will be featured on Sunday, May 5, during a lunch symposium entitled “A Brighter Path to Higher Quality,” with a welcome from Tom Logan, CEO of Mirion and acting Mirion Medical President.

The Debut of SunCHECK v5.0

The recently announced SunCHECK v5.0 solution will be prominently featured, with daily scheduled presentations and in-depth demonstrations at the Sun Nuclear booth. This landmark update delivers functionality to better connect SunCHECK users and radiation treatment workflows, including advanced treatment plan assessment tools, additional integration with linac treatment planning systems (TPS) and oncology information systems (OIS), broader QA device control, and a refreshed, worklist-based user interface. ESTRO attendees are invited to explore these features and discover how the software enhances efficiency and quality in the clinic.

New for Surface-Guided Radiation Therapy QA

Also making its debut at ESTRO, the AVa™ Phantom (Alignment Verification accessory) extends utility of the gold standard StereoPHAN™ and SRS MapCHECK® solutions for end-to-end QA, to encompass surface-guided radiation therapy (SGRT) applications. A rigid accessory that replicates human facial and cranial features, the AVa Phantom enables comprehensive tracking for enhanced confidence in clinical delivery.

Enhancements for Machine QA & Motion Management

Ongoing updates to SunDOSE™ software for commissioning and machine quality, including TPS Dose Comparison and Live Scan QA functionalities, allow users faster understanding of treatment planning system model accuracy and saves time by proactively warning clinical users if scan parameters are incorrect or changes in the delivery machine are detected. This software will be featured during daily SunSCAN™ 3D water scanning system demonstrations. For motion management, the Dynamic Thorax Phantom now offers a deformable-surface accessory for deviceless 4D CT system QA.

“We are excited to present a robust suite of solutions for radiation therapy teams during this year’s ESTRO, including investments we have made in the SunCHECK Platform with version 5.0,” said Luis Rivera, Sun Nuclear Radiation Therapy QA President. “We’re equally pleased to see the great work of our customers represented in the scientific program. Throughout the meeting, we look forward to exchanging ideas on best practices and new innovations that support more efficient clinical workflows and advanced patient care.”

Expanded Offerings for Cancer Care

Featured in the Sun Nuclear booth are Diagnostic Imaging QA solutions from Sun Nuclear, as well as a suite of healthcare-focused solutions from Mirion Technologies. These solutions leverage decades of Mirion leadership in area monitoring and active dosimetry — critical aspects of safety and compliance for facilities using radiation in diagnosis and care.

In addition, the new Instadose®VUE personal wireless dosimeter from Mirion Dosimetry Services offers a revolutionary approach to radiation exposure monitoring, with unmatched flexibility and convenience for workplace safety. Visit the Mirion Medical solutions counter within the Sun Nuclear booth to see these innovations firsthand.

To learn more, visit sunnuclear.com/estro.

About Sun Nuclear

Sun Nuclear is part of Mirion Medical, a group of healthcare-focused brands within Mirion. We provide innovative solutions for Radiation Therapy and Diagnostic Imaging centers. More than 5,000 cancer centers worldwide rely on us for independent, integrated Quality Management. With a focus on ongoing support, Sun Nuclear aims to ease technology adoption, enhance workflows and improve outcomes – so that healthcare providers can achieve real results for Patient Safety. Visit us: sunnuclear.com. Follow us: @sunnuclear.

The AVa phantom is patent-pending and not for sale in all markets. SunCHECK v5.0, Health Physics for Healthcare products, and Dynamic Thorax Phantom are not available for sale in all markets.

Sun Nuclear, SunCHECK, AVa, StereoPHAN, SRS MapCHECK, SunDOSE, SunSCAN 3D, and InstadoseVUE are trademarks or registered trademarks of Mirion Technologies, Inc. and/or its affiliates in the United States and/or other countries.

Contacts

For investor inquiries:
Jerry Estes

ir@mirion.com

For media inquiries:
Erin Schesny

media@mirion.com

Solid Start to the Year: LEO Pharma Delivers 13% Revenue Growth Driven by Strong Performance in Dermatology

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Solid Start to the Year: LEO Pharma Delivers 13% Revenue Growth Driven by Strong Performance in Dermatology




Solid Start to the Year: LEO Pharma Delivers 13% Revenue Growth Driven by Strong Performance in Dermatology

Q1 2024 Trading Update

(Unaudited)




COPENHAGEN–(BUSINESS WIRE)–In Q1 2024, LEO Pharma delivered a revenue growth of 13% in constant exchange rates (CER). The dermatology portfolio saw accelerated growth in revenue of 16%. The acquisition of TMB-001 to the treatment of congenital ichthyosis added a late-stage asset to LEO Pharma’s medical dermatology pipeline, and delgocitinib for chronic hand eczema (CHE) is on track for its planned European launch in Q4 2024. Full-year outlook has been revised slightly upwards.

Q1 2024 financial highlights

  • Revenue grew 13% to DKK 3,064 million (Q1 2023: 2,763 million). Reported growth was 11%.
  • Dermatology revenue grew 16% to DKK 2,444 million (Q1 2023: 2,150 million), driven by growth of Adtralza®/Adbry® for atopic dermatitis (AD) and solid growth in the core portfolio.
  • Adbry®/Adtralza® revenue increased by 90% driven by continued uptake across markets.
  • Core dermatology portfolio delivered growth of 9% across our Affiliate and Alliance markets. Growth largely driven by the Fucidin® Range, Enstilar® and Protopic® across our eczema, psoriasis and skin infection portfolios.
  • Growth across all regions: North America up 42%, Europe up 6%, Rest of the World up 15%. North America continues to be the key growth driver with revenue of DKK 439 million (Q1 2023: 313 million).

Progress on strategic priorities

  • To advance the growth of our U.S. business, LEO Pharma added a late-stage asset to our medical dermatology pipeline by finalizing the strategic acquisition of TMB-001 to the treatment of congenital ichthyosis. In Q1 2024, patient recruitment was completed for the Phase III ASCEND trial.
  • The recent results of the successful DELTA FORCE-trial comparing delgocitinib to current standard of care, further confirms delgocitinib’s potential to become a key growth driver for the company and we will be investing additional resources in accelerating the launch of this potential treatment to patients.
  • Regulatory review of the marketing authorization application is pending in the EU, and based on the positive outcome of the DELTA clinical program, LEO Pharma is assessing ways to bring this potential treatment to other markets as well, including the U.S.
  • Adbry® (tralokinumab-ldrm) data from the ECZTEND trial was shared during the American Academy of Dermatology (AAD) Annual Meeting investigating the stability of long-term therapeutic responses to tralokinumab in adults with moderate-to-severe AD.

“First quarter marks a solid start to 2024 with a 13% revenue growth and continued progress on our strategic priorities. I am pleased with the strong growth track record for our global dermatology portfolio, primarily driven by performance in North America. Furthermore, I am excited about the progress we are making in building evidence and bringing delgocitinib to the market to help patients with chronic hand eczema. The positive results from the recently completed head-to-head trial against current standard of care make us even more motivated to accelerate our efforts,” says CEO Christophe Bourdon.

2024 financial outlook

  • Following our strong Q1 2024 performance, we are revising our full-year revenue growth outlook upwards compared to what was shared in the Annual Report on 29th February 2024. Full-year revenue growth is now projected to be 5-8% in CER (before: 4-8%).
  • Potential changes in key assumptions for market growth and unexpected health care and pricing reforms are risk factors, among others, which could change the outlook for the year.

Sales performance

In Q1 2024, revenue grew 13% (CER) to DKK 3,064 million from DKK 2,763 million in the same period last year, corresponding to a reported growth in DKK of 11%. Dermatology revenue was a significant contributor with 16% in CER. While growth is attributed to the performance of both recently launched dermatology products Adtralza®/Adbry®, as well as core dermatology products, a part of growth was also attributable to timing of shipments especially in rest of world.

LEO Pharma expects to issue a company announcement on the financial performance and progress on strategic priorities in the first half of 2024 on 26 August 2024.

Ballerup, 3 May 2024,

LEO Pharma 

About LEO Pharma

LEO Pharma is a global company dedicated to advancing the standard of care for the benefit of people with skin conditions, their families and society. Founded in 1908 and majority owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, and today, the company offers a wide range of therapies for all disease severities. LEO Pharma is headquartered in Denmark with a global team of approx. 4,200 people, serving millions of patients across the world. In 2023, the company generated net sales of DKK 11.4 billion.

Forward-looking statements

This announcement contains forward-looking statements, including forecasts of future revenue and operating profit, as well as expected business-related events. Such statements are subject to risks and uncertainties, as various factors, some of which are beyond LEO Pharma’s control, may cause actual results and performance to differ materially from the forecasts made in this announcement.

Contacts

Media: Jeppe Ilkjær, mobile +45 3050 2014

Soleno Therapeutics Announces Pricing of Approximately $138 Million Public Offering Of Common Stock

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Soleno Therapeutics Announces Pricing of Approximately $138 Million Public Offering Of Common Stock




Soleno Therapeutics Announces Pricing of Approximately $138 Million Public Offering Of Common Stock

REDWOOD CITY, Calif., May 02, 2024 (GLOBE NEWSWIRE) — Soleno Therapeutics, Inc. (Nasdaq: SLNO), (“Soleno” or the “Company”), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, announced today the pricing of the underwritten public offering of 3,000,000 shares of its common stock at a public offering price of $46.00 per share. The gross proceeds of the public offering are expected to be approximately $138.0 million, before deducting underwriting discounts and commissions and other estimated offering expenses. Soleno has also granted the underwriters a 30-day option to purchase up to 450,000 shares of common stock at the public offering price, less underwriting discounts and commissions. The public offering is expected to close on or about May 7, 2024, subject to market conditions and the satisfaction of customary closing conditions.

Piper Sandler, Guggenheim Securities, Cantor Fitzgerald & Co. and Oppenheimer & Co. are acting as joint book-running managers for the public offering.  Laidlaw & Company (UK) Ltd. is acting as the lead manager for the public offering.

Soleno intends to use the net proceeds from this offering to fund its current research and development efforts primarily focused on advancing its lead candidate, DCCR tablets for the treatment of Prader-Willi Syndrome (PWS), and to provide for general corporate purposes, which may include working capital, capital expenditures, other clinical trials, other corporate expenses and acquisitions of complementary products, technologies or businesses, though the company does not have agreements or commitments for any specific acquisitions at this time.

The securities described above relating to the public offering are being offered by Soleno pursuant to a registration statement on Form S-3ASR (File No. 333-276344) previously filed with, and automatically declared effective by the Securities and Exchange Commission (the “SEC”) on January 2, 2024, and a preliminary prospectus supplement filed with the SEC on May 2, 2024. A final prospectus supplement and an accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at http://www.sec.gov. When available, copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained from Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, Attention: Prospectus Department, by telephone at (800) 747-3924, or by email at prospectus@psc.com; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th floor, New York, NY 10017 by telephone at (212) 518-9544, or by email at GSEquityProspectusDelivery@guggenheimpartners.com. Electronic copies of the final prospectus supplement and accompanying prospectus will also be available on the website of the SEC at www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction. The offering will be made only by means of a prospectus supplement and the accompanying prospectus that forms a part of the registration statement.

About Soleno Therapeutics, Inc.

Soleno is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases. The Company’s lead candidate, DCCR (diazoxide choline) extended-release tablets, a once-daily oral tablet for the treatment of Prader-Willi syndrome (PWS), recently completed its Phase 3 development program to support a planned NDA submission.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward-looking statements, including statements regarding the Company’s expectations on the completion and timing of the public offering and the anticipated use of proceeds therefrom. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including the risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions related to the public offering, as well as risks and uncertainties inherent in Soleno’s business, including those described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, prior press releases and in other filings and reports filed with the SEC. The events and circumstances reflected in the Company’s forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, the Company does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Corporate Contact:

Brian Ritchie
LifeSci Advisors, LLC
212-915-2578 

Epredia and NovaScan Announce Intent to Enter U.S. Distribution Agreement for MarginScan™ Device for Non-Melanoma Skin Cancer Detection

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Avantik to Serve as Primary Distribution Partner

PORTSMOUTH, N.H.–(BUSINESS WIRE)–#CancerDiagnostics–Epredia, a global leader in precision cancer diagnostics and subsidiary of PHC Holdings Corporation (TSE: 6523), and NovaScan, Inc., a company that develops breakthrough technology for cancer detection and stratification, announce that they have signed a letter of intent for a U.S. exclusive commercial distribution agreement for MarginScan™, a medical device that will support physicians in real-time detection of non-melanoma skin cancer. Epredia has engaged Avantik, a company specializing in supporting diagnostic labs with their operations, with getting this new device into the hands of Mohs surgeons.

Skin cancer is the most common group of cancers diagnosed worldwide1, and it is estimated that one in five Americans will develop skin cancer in their lifetime2. Non-melanoma skin cancers (NMSC) are the most common cancers in the United States, affecting more than 3 million Americans a year3. More than 20 percent of Americans are expected to develop NMSC before reaching age 70. Most surgeries for NMSC are simple excisions, which may result in removal of substantial healthy tissue around the suspected cancer.

MarginScan™ is designed to address this challenge by supporting Mohs surgery procedures for skin cancer treatment. Mohs Micrographic Surgery (MMS) is an operative method used to detect the presence or absence of a tumor in the margins of a surgical excision. In an MMS procedure, cancer tissue is excised in stages, then flash-frozen and assessed histologically in an onsite lab until clean margins are obtained. Previously, MMS was the only modality for skin cancer treatment that involved comprehensive margin assessment during a procedure. MarginScan™ is designed to use an electrical assessment to confirm cancer-free margins without the intraoperative histological assessment. This has the potential to allow for faster excisions that spare more healthy tissue, leading to improved outcomes for both patients and clinicians.

With this planned agreement, Epredia will serve as the primary distribution partner of MarginScan™ and will have exclusive distribution rights in the United States. Along with distribution, Epredia will be responsible for all marketing and commercial activities related to the launch and sale of MarginScan™. Epredia will work closely with Avantik to market and sell the new device to Mohs surgeons.

MarginScan™ will be the latest addition to Epredia’s world-class portfolio of precision cancer diagnostics products and services that provide a seamless end-to-end laboratory workflow, including slide scanners and printers, cryostats, tissue processors, and consumables such as slides and reagents. In addition to offering MarginScan™, Epredia will also provide consumable products that are used with the device, such as the MarginScan™ electrode and proprietary electrolytic gel used during excisions.

The two companies anticipate a 2025 U.S. launch for MarginScan™. This distribution agreement builds on a previous partnership between NovaScan and PHC Corporation, another subsidiary of PHC Holdings Corporation that is focused on the development and manufacturing of innovative medical testing devices. PHC Holdings Corporation is referred to collectively with its subsidiaries as PHC Group.

Steven Lynum, President of Epredia, said, “With more than 85 years supporting precision cancer diagnostics, we strive to continuously serve the changing needs of our customers by working with innovative companies like NovaScan to deliver the best solutions. Helping providers make faster, more accurate diagnoses and ultimately improving patient care is what makes this initiative so important.”

Craig Davis, CEO of NovaScan, remarked, “NovaScan is thrilled to be partnering with Epredia to bring MarginScan™ to clinical healthcare providers in the U.S. We are proud for MarginScan™ to join Epredia’s portfolio of market-leading cancer diagnostics products. We believe that MarginScan™ will play an important role in skin cancer detection and treatment.”

Mark Zacur, CEO of Avantik, added, “Our team is continually sourcing the best solutions to expand our portfolio of solutions supporting Mohs clinics with their critical work. We are honored that Epredia selected Avantik as their partner to bring this breakthrough device to our network of providers and their patients.”

About Epredia

Epredia is a global leader in the anatomical pathology field, providing comprehensive solutions for precision cancer diagnostics and tissue diagnostics. Powered by key brands, including Erie Scientific, Menzel-Gläser, Microm, Shandon, and Richard-Allan Scientific, Epredia’s portfolio includes microscope slides, instruments and consumables. Epredia was established following the acquisition of Thermo Fisher Scientific’s Anatomical Pathology business by PHC Holdings in 2019. Epredia has operations in major sites in the United States, the United Kingdom, Germany, Switzerland and China with a total of around 1,200 employees. Epredia is committed to achieving its mission to improve lives by enhancing cancer diagnostics for patients around the world. For further information on Epredia and its products, please visit www.epredia.com.

About PHC Holdings Corporation (PHC Group)

PHC Holdings Corporation (TSE 6523) is a global healthcare company with a mission of contributing to the health of society through healthcare solutions that have a positive impact and improve the lives of people. Its subsidiaries (referred to collectively as PHC Group) include PHC Corporation, Epredia, Ascensia Diabetes Care, LSI Medience Corporation, Mediford, and Wemex. Together, these companies develop, manufacture, sell and service solutions across diabetes management, healthcare solutions, life sciences and diagnostics. PHC Group’s consolidated net sales in FY2022 were JPY 356.4 billion with global distribution of products and services in more than 125 countries and regions. www.phchd.com

About NovaScan

About NovaScan: Based in Chicago, NovaScan (www.novascaninc.com) is a clinical stage oncology diagnostic and stratification company that has developed a low cost, point of care platform for real time cancer detection and stratification. NovaScan’s platform is active in skin, GI, lung and breast.

About Avantik

Founded in 1971, Avantik specializes in supporting diagnostic laboratories with maintaining their critical operations. The company offers a national network of more than 250 engineers, technicians and service personnel that assist diagnostic labs with increasing their productivity, enhancing their products and streamlining their processes. It also manages a comprehensive inventory of high-quality lab equipment and consumables that it continually expands to provide labs with new products that advance their goals for fast and accurate diagnoses. In 2023, Avantik partnered with Water Street Healthcare Partners, an investment firm dedicated to building market leaders in health care, to advance its goals for expansion and building on its legacy as a trusted partner to diagnostic laboratories. To learn more about Avantik, visit www.avantik-us.com.

1 Source: World Health Organization.

2 Source: World Health Organization.

3 Source: American Academy of Dermatology.

Contacts

Julia Cottrill

PHC Group Corporate Communications

julia.cottrill@phchd.com