On February 1, 2024 Celularity Inc. (Nasdaq: CELU) (the "Company") a biotechnology company developing allogeneic cell therapies and advanced biomaterial products, reported expected net sales of its biomaterial products and biobanking businesses for the first quarter 2024 and the full year 2024, respectively, and reiterated its previously disclosed advanced biomaterial product commercial and development pipeline (Press release, Celularity, FEB 1, 2024, https://celularity.com/celularity-announces-net-sales-expectations-for-first-quarter-2024-and-full-year-2024-reiterates-advanced-biomaterial-product-commercial-and-development-pipeline/ [SID1234639770]). As used here, "net sales" refers exclusively to revenue from the sale of advanced biomaterial products and biobanking services, respectively, and does not include any revenue from other sources such as license fees and royalties or revenue earned under research collaboration agreements.

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For the first quarter 2024, the Company expects combined net sales of its advanced biomaterial product and biobanking businesses to be in the range of $10.25 million to $11.5 million, consisting of expected net sales for its advanced biomaterial product business in the range of $9.0 million to $10.0 million and expected net sales for its biobanking business in the range of $1.37 million to $1.50 million. For the first quarter 2024, the Company expects net sales percentage growth for its advanced biomaterial product business to be in the range of 249% to 287% and net sales percentage growth of its biobanking business to be in the low single to low double-digit range, both compared to the first quarter 2023.

For the full year 2024, the Company expects combined net sales of its advanced biomaterial product and biobanking businesses to be in the range of $50 million to $56 million, consisting of expected net sales of its advanced biomaterial product business in the range of $45.0 million to $50.0 million and expected net sales of its biobanking business in the range of $5.5 million to $6.0 million. For the full year 2024, the Company expects net sales percentage growth of its advanced biomaterial product business to be in the range of 165% to 194% and net sales percentage growth of its biobanking business to be in the in the single digit range, both compared to full year 2023.

"Our sales of advanced biomaterial products grew dramatically in the fourth quarter of 2023 as our newest Biovance 3L product gained traction. We hope to build on the net sales growth we observed in the fourth quarter 2023 and continue to grow net sales of our advanced biomaterial products in 2024, which if achieved would meaningfully increase cash provided by operations and move us toward our goal of becoming a cashflow positive enterprise," said Robert J. Hariri, M.D., Ph.D., Chairman, Chief Executive Officer, and founder. "We believe Celularity is a novel pairing of commercial-stage, cashflow generating advanced biomaterial product and biobanking businesses and a clinical-stage cell therapy business, all enabled by a unique technology platform that combines cellular and regenerative medicine technologies," Hariri noted. "We are optimistic about our unique business model and encouraged by the organic growth in revenues, which we intend to complement through expanding into new markets," said Dr. Hariri, who added, "So far, we see January sales of our advanced biomaterial products trending above our expected net sales for the first quarter 2024. We are continuing to explore ways to leverage our unique technology platform, GMP manufacturing infrastructure, and intellectual property portfolio to attract even more commercial and development relationships that are accretive in the near and long-term."

The Company in 2024 expects to continue to improve the operational effectiveness of its advanced biomaterial product business and to prepare for a possible second half 2024 commercial launch of a new product for wound care and surgical applications. In addition, the Company expects to pursue additional advanced biomaterial product contract manufacturing opportunities under which it provides product development and manufacturing services for a third party which then sells the product(s) under its own brand name(s). For example, in December 2023, the Company entered into a contract manufacturing arrangement with BioCellgraft Inc. ("BioCellgraft") under which it agreed to manufacture multiple advanced biomaterial products for BioCellgraft that BioCellgraft will sell in the United States under its own brand names for use in various oral health applications. The Company expects in 2024 to continue to assess opportunities to sell its advanced biomaterial products outside the United States but has, at this time, not included any amount attributable to ex-US sales in expected first quarter 2024 or expected full year 2024 net sales.

The Company expects in future to update expected full year 2024 net sales of its advanced biomaterial product and biobanking businesses. Additionally, the Company expects later this year to initiate 2024 operating earnings guidance ranges.

The Company’s advanced biomaterial product pipeline consists of four commercial-stage products and three development-stage product candidates. The commercial-stage products are off-the-shelf placental-derived allogeneic allografts and connective tissue matrices that it markets primarily under its own brands in the U.S. for use in soft tissue repair and reconstructive procedures including acute and chronic non-healing wounds and burns:

Biovance, a human amniotic membrane allograft designed to cover or offer protection from the surrounding environment in soft tissue repair and reconstructive procedure.
Biovance3L, a Tri-Layer Biovance human amniotic membrane allograft designed for use as a covering, barrier, or wrap to surgical sites and to support the treatment of ocular surface disease and ocular surgical applications.
Interfyl, a decellularized human placental connective tissue matrix designed for use to replace or supplement damaged or inadequate integumental tissue.
CentaFlex, a decellularized human placental matrix allograft derived from human umbilical cord designed for use as a surgical covering, wrap, or barrier to protect and support the repair of damaged tissues.
The Company currently is developing three advanced biomaterial product candidates for indications that include aging-associated and other degenerative diseases and disorders characterized by the progressive loss of function and/or structure of the affected tissues:

SPARK Celularity Tendon Wrap, a high strength scaffold composed of collagen and other native proteins derived from decellularized human placental tissue that the Company is developing for use in the management and protection of tendon injuries.
FUSE Celularity Bone Void Filler, an easy to handle, moldable bone void filler composed of collagen and other native proteins derived from decellularized human placental tissue that the Company is developing for use as a passive osteoconductive bone filler in the pelvis, extremities, and posterior-lateral spinal fusion settings as well as other skeletal defects.
ORCHID Celularity Placental Matrix, a fully resorbable device composed of extracellular matrix derived from decellularized human placental tissue that the Company is developing for use as a passive temporary wound covering and in aesthetics.

The Company’s advanced biomaterial product developmental pipeline includes human placental tissue derived scaffolds that it expects to be regulated in the United States as a device under Section 510(k) of the Food, Drug and Cosmetic Act. Both the Company’s SPARK Celularity Tendon Wrap and FUSE Celularity Bone Void Filler completed preliminary non-binding product classifications and jurisdictional assessments by the U.S. Food and Drug Administration ("FDA") Office of Combination Products ("OCP") to be regulated as a device by the FDA Center for Devices and Radiologic Health. Based on the OCP’s preliminary assessment, the Company intends to submit a 510(k) notification for its SPARK Celularity Tendon Wrap in the second half of 2024 and for its FUSE Celularity Bone Void Filler in the second half of 2025. The Company is developing its ORCHID Celularity Placental Matrix as a Class III medical device for which it would be required to submit a premarket approval application ("PMA") to the FDA. In addition, the Company has a discovery phase program to investigate a human placenta-derived exosome which consists of cytokines, chemokines, and growth factors that have been reported to have regenerative and immuno-regulatory activities for a potential indication, alone or in combination with extracellular matrix derived from decellularized human placental tissue, in mild to moderate knee osteoarthritis, a degenerative joint disease of the knee that is the most prevalent form of osteoarthritis and a leading source of chronic pain and disability in the U.S.

On February 1, 2024 Cardinal Health (NYSE: CAH) reported second quarter fiscal 2024 revenue of $57.4 billion, an increase of 12% from the second quarter of last year (Press release, Cardinal Health, FEB 1, 2024, View Source [SID1234639769]). Second quarter GAAP operating earnings were $482 million and GAAP diluted earnings per share (EPS) were $1.43. Second quarter non-GAAP operating earnings increased 20% to $562 million, driven by strong growth in both Pharmaceutical segment profit and Medical segment profit. Non-GAAP diluted earnings per share (EPS) increased 38% to $1.82, driven by four factors: the increase in non-GAAP operating earnings, a lower share count following incremental share repurchase activity, lower interest and other expense and a lower non-GAAP effective tax rate.

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"We delivered strong second quarter results across the enterprise, demonstrating continued momentum against our strategic priorities," said Jason Hollar, CEO of Cardinal Health. "With strong growth in Pharmaceutical segment profit and continued progress against our Medical Improvement Plan, we are continuing to drive operational execution in our core business. Along with our recent announcements of a tech-enabled specialty acquisition and growth portfolio prioritization, we remain focused on best serving our customers and creating value for our shareholders."

"With our first half performance including positive operating leverage, incremental return of capital to shareholders beyond our baseline plans, and confidence in our efforts as we look ahead, we are pleased to again raise our FY24 non-GAAP EPS guidance, which reflects 26% growth at the mid-point compared to our FY23 results," said Aaron Alt, CFO of Cardinal Health.

Q2 FY24 summary

Q2 FY24

Q2 FY23

Y/Y

Revenue

$57.4 billion

$51.5 billion

12 %

Operating earnings/(loss)

$482 million

$(119) million

N.M.

Non-GAAP operating earnings

$562 million

$467 million

20 %

Net earnings/(loss) attributable to Cardinal Health, Inc.

$353 million

$(130) million

N.M.

Non-GAAP net earnings attributable to Cardinal Health, Inc.

$447 million

$346 million

29 %

Effective Tax Rate

27.7 %

5.4 %4

Non-GAAP Effective Tax Rate

21.3 %

23.0 %

Diluted EPS attributable to Cardinal Health, Inc.

$1.43

$(0.50)

N.M.

Non-GAAP diluted EPS attributable to Cardinal Health, Inc.

$1.82

$1.32

38 %

Segment results

Pharmaceutical segment

Q2 FY24

Q2 FY23

Y/Y

Revenue

$53.5 billion

$47.7 billion

12 %

Segment profit

$518 million

$464 million

12 %

Second quarter revenue for the Pharmaceutical segment increased 12% to $53.5 billion, driven by brand and specialty pharmaceutical sales growth from existing customers.

Pharmaceutical segment profit increased 12% to $518 million in the second quarter, driven by positive generics program performance and a higher contribution from brand and specialty products, including distribution of COVID-19 vaccines. This increase was partially offset by higher costs to support sales growth.

Medical segment

Q2 FY24

Q2 FY23

Y/Y

Revenue

$3.9 billion

$3.8 billion

3 %

Segment profit

$71 million

$17 million

N.M.

Second quarter revenue for the Medical segment increased 3% to $3.9 billion, driven by growth in at-Home Solutions and Global Medical Products and Distribution, which primarily reflects higher Cardinal Health Brand volumes.

Medical segment profit increased by $54 million to $71 million in the second quarter, driven by an improvement in net inflationary impacts, including mitigation initiatives.

Fiscal 2024 outlook2

The company raised its fiscal 2024 guidance range for non-GAAP diluted earnings per share attributable to Cardinal Health, Inc. to $7.20 to $7.35, from $6.75 to $7.003.

The company reiterated its expectations for segment profit growth for the former Pharmaceutical Segment of 7% to 9% and updated its fiscal 2024 segment profit outlook for the former Medical Segment to approximately $380 million, from approximately $400 million.

Additionally, the company now expects interest and other in the range of $50 million to $65 million, diluted weighted average shares outstanding of approximately 247 million, a non-GAAP effective tax rate of 23% to 24% and non-GAAP adjusted free cash of approximately $2.5 billion.

Pro-forma fiscal 2024 outlook, updated segment structure

As announced on January 9, 2024, the company updated its enterprise operating and segment reporting structure, effective January 1, 2024, to be reflected in the company’s financial reporting beginning third quarter fiscal 2024. Therefore, the company provided preliminary guidance for fiscal 2024 according to its updated segment reporting structure.

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FY23 Actuals5

FY24 Outlook

Long-term Target

Businesses

Pharmaceutical and
Specialty Solutions

Revenue:

~$188.8B

Segment Profit:

~1.87B

Revenue:

10% to 12% growth

Segment Profit:

7% to 9% growth

4-6%

Segment Profit CAGR6

Former Pharmaceutical Segment,
excluding Nuclear and Precision
Health Solutions

GMPD

Revenue:

~$12.1B

Segment Profit:

~$(165)M

Revenue:

~2% growth

Segment Profit:

~$65M

~$300 million

in Segment Profit by FY267

Former Medical Segment,
excluding at-Home Solutions and OptiFreight
Logistics

Other

Revenue:

~$4.1B

Segment Profit:

~$410M

Revenue:

~10% growth

Segment Profit:

6% to 8% growth

8-10%

Segment Profit CAGR6

at-Home Solutions, Nuclear and
Precision Health Solutions and
OptiFreight Logistics

The company does not provide forward-looking guidance on a GAAP basis as certain financial information, the probable significance of which cannot be determined, is not available and cannot be reasonably estimated. See "Use of Non-GAAP Measures" following the attached schedules for additional explanation.

Recent highlights

Cardinal Health announced progress on the company’s business and portfolio review on January 9, 2024. The company completed its review of the growth businesses within the former Medical Segment, determining to invest in and further develop at-Home Solutions and OptiFreight Logistics as part of the company’s portfolio for long-term growth and value creation. The company’s review of the Global Medical Products and Distribution business continues, with a focus on driving operational performance through the Medical Improvement Plan.
Cardinal Health completed a $250 million accelerated share repurchase program in the second quarter, resulting in a total of $750 million year-to-date share repurchases in fiscal 2024.
Cardinal Health announced plans to build a new at-Home Solutions distribution center in Texas, with increased capacity, advanced automation and robotics within the facility.
Upcoming webcasted investor events

Barclays 26th Annual Global Healthcare Conference at 8:30 a.m. EST, March 13, 2024.
Webcast
Cardinal Health will host a webcast today at 8:30 a.m. Eastern to discuss second-quarter results. To access the webcast and corresponding slide presentation, go to the Investor Relations page at ir.cardinalhealth.com. No access code is required.

Presentation slides and a webcast replay will be available on the Investor Relations page for 12 months.

On February 1, 2024 BullFrog AI Holdings, Inc. (NASDAQ:BFRG; BFRGW) ("Bullfrog AI" or the "Company"), a technology-enabled drug development company using artificial intelligence (AI) and machine learning to enable the successful development of pharmaceuticals and biologics, reported the pricing of an underwritten public offering of an aggregate of 1,507,139 shares of common stock (or pre-funded warrants ("Pre-Funded Warrants") in lieu thereof) and accompanying warrants to purchase 1,507,139 shares of common stock at a public offering price of $3.782 per share (inclusive of the Pre-Funded Warrant exercise price) for gross proceeds of approximately $5,700,000, prior to deducting underwriting discounts and offering expenses (Press release, Bullfrog AI, FEB 1, 2024, View Source [SID1234639768]). In addition, the Company has granted the underwriters a 45-day option to purchase an additional 226,071 shares of common stock (and/or Pre-Funded Warrants in lieu thereof) and/or warrants to purchase 226,071 shares of common stock to cover over-allotments at the public offering price, less the underwriting discount.

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The Company intends to use the net proceeds from the offering for working capital and other general corporate purposes. The offering is expected to close on February 5, 2024, subject to satisfaction of customary closing conditions.

WallachBeth Capital, LLC is acting as sole book-running manager for the offering.

A registration statement on Form S-1 (File No. 333-276740) relating to the securities was filed with the Securities and Exchange Commission ("SEC") and became effective on January 31, 2024. This offering is being made only by means of a prospectus. Copies of the final prospectus related to the offering may be obtained, when available, from WallachBeth Capital, LLC, via email: [email protected], or by calling +1 (646) 237-8585, or by standard mail at WallachBeth Capital, LLC, Attn: Capital Markets, 185 Hudson St, Jersey City, NJ 07311, USA. In addition, a copy of the final prospectus, when available, relating to the offering may be obtained via the SEC’s website at www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On February 1, 2024 Abeona Therapeutics Inc. (Nasdaq: ABEO) reported that it has granted equity awards to new non-executive employees who joined the Company (Press release, Abeona Therapeutics, FEB 1, 2024, View Source [SID1234639767]). The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4).

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On January 31, 2024, the Compensation Committee of Abeona’s Board of Directors granted restricted stock equity awards as a material inducement to employment to three individuals hired by Abeona, which equity awards relate to, in the aggregate, up to 81,000 restricted shares of Abeona common stock. One-third of the shares subject to such restricted stock awards will vest yearly on each anniversary of the Grant Date, such that the shares subject to such restricted stock awards granted to each employee will be fully vested on the third anniversary of the Grant Date, in each case, subject to each employee’s continued employment with Abeona on the applicable vesting dates.