On January 10, 2023 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported its 2023 financial guidance and commented on its outlook for the upcoming year (Press release, Halozyme, JAN 10, 2023, View Source [SID1234626165]).

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"In 2022, we project we achieved record revenue of greater than $655 million and we completed the acquisition of Antares Pharma, opening up an expanded set of opportunities for our subcutaneous drug delivery business," said Dr. Helen Torley, president and chief executive officer. "In 2023, we project record revenue of $815 to $845M and greater than 30% growth in EBITDA to $415 to $440 million. As our ENHANZE pipeline advances, we are excited about the future royalty revenue opportunities represented in 2023 by the potential for two new commercial launches, SC efgartigimod and SC atezolizumab."

Anticipated 2023 Key Events:

Projected growth of >20% in the Company’s high-margin, recurring revenue stream from royalties to approximately $445 to $455 million driven by continued strength in Wave 2 products, including DARZALEX SC (daratumumab) and Phesgo (pertuzumab, trastuzumab and hyaluronidase) utilizing ENHANZE technology, as well as full year auto-injector royalty contribution.

Two ENHANZE subcutaneous (SC) approvals and commercial launches by collaboration partners, including SC efgartigimod and SC atezolizumab.

Four Phase 3 study data readouts from products utilizing ENHANZE by the Company’s collaboration partners
SC efgartigimod in CIDP, ITP and Pemphigus (autoimmune disorders of the nervous system, blood and skin)
SC ocrelizumab for certain patients with multiple sclerosis
At least 2 new products utilizing ENHANZE entering Phase 1 development by the Company’s collaboration partners.
At least one new collaboration and licensing agreement for ENHANZE, for a partner to test our developmental large volume auto-injector plus ENHANZE, and for our small volume auto-injector.

Initiation of a clinical study to continue to evaluate the feasibility testing of our large volume auto-injector.
Up to $150 million in share repurchases, dependent on market conditions and other factors, as part of the $750 million three-year share repurchase plan authorized by Halozyme’s board of directors in December 2021 demonstrating the Company’s continued commitment to a balanced capital allocation strategy.

2023 Financial Guidance:

Revenue: Halozyme expects total revenue of $815 million to $845 million, representing growth of >20% over 2022 expected total revenue. The Company expects revenue from royalties to increase >20% over expected revenue from royalties in 2022, to a range of $445 million to $455 million.
EBITDA: Halozyme expects EBITDA of $415 million to $440 million, representing growth of >30% over 2022 expected EBITDA and excludes the impact of amortization costs in 2023 related to the Antares Pharma acquisition.
Earnings per Share: Halozyme expects Non-GAAP diluted earnings per share of $2.50 to $2.65. The Company’s earnings per share guidance does not consider the impact of potential future share repurchases.
Table 1. 2023 Financial Guidance

Guidance Range

Total Revenue

$815 to $845 million

Royalty Revenue

$445 to $455 million

EBITDA

$415 to $440 million

Non-GAAP Diluted EPS

$2.50 to $2.65

On January 10, 2023 Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZS) ("Aeterna" or the "Company"), a specialty biopharmaceutical company developing and commercializing a diversified portfolio of pharmaceutical and diagnostic products, reported that Dr. Klaus Paulini, Chief Executive Officer of Aeterna Zentaris, will present at the Virtual Investor 2023 Companies to Watch Event on Thursday, January 19, 2023 at 3:00 PM ET (Press release, AEterna Zentaris, JAN 10, 2023, View Source;id=251411&p=2254175&I=1206939-c7Z3G6f3m8 [SID1234626164]).

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A live video webcast of the presentation will be available on the Events page of the Company’s website (www.zentaris.com). A webcast replay will be available two hours following the live presentation and will be accessible for 90 days.

On january 10, 2023 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, reported that company management will participate in a fireside chat at B. Riley Securities’ 3rd Annual Oncology Conference, which is taking place virtually from January 18 – 19, 2023 (Press release, Cardiff Oncology, JAN 10, 2023, View Source [SID1234626163]).

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On January 10, 2023 Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, reported the closing of its upsized underwritten public offering of common stock and pre-funded warrants, plus the full exercise of the underwriters’ option to purchase additional shares of common stock for total gross proceeds of $227.8 million (Press release, Geron, JAN 10, 2023, View Source [SID1234626162]). All of the securities in the offering were sold by Geron.

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The estimated net proceeds to Geron from this underwritten public offering, after deducting the underwriting discount and other estimated offering expenses, are approximately $213.3 million. Geron currently intends to use the net proceeds from this public offering, together with its existing cash, cash equivalents, restricted cash and current and noncurrent marketable securities, to fund preparatory activities for the potential U.S. commercial launch of imetelstat in lower risk MDS, and, if approved, to fund the potential U.S. commercial launch of imetelstat. Geron intends to use the remaining proceeds, if any, for working capital and general corporate purposes.

The public offering consisted of 68,007,741 shares of Geron’s common stock at a price to the public of $2.45 per share, including 12,131,444 shares of common stock pursuant to the full exercise of the underwriters’ option to purchase additional shares, and pre-funded warrants to purchase 25,000,000 shares of Geron’s common stock at a price to the public of $2.449 per pre-funded warrant.

Goldman Sachs & Co. LLC and Stifel acted as joint book-running managers for the offering. Wedbush PacGrow and Baird acted as co-lead managers for the offering. B. Riley Securities and Needham & Company acted as co-managers for the offering.

An automatically effective shelf registration statement on Form S-3 relating to the public offering of the shares of common stock and pre-funded warrants described above was filed with the Securities and Exchange Commission (SEC) on January 4, 2023. A final prospectus supplement and accompanying prospectus relating to and describing the terms of the offering has been filed with the SEC and is available on the SEC’s web site at www.sec.gov. When available, copies of the final prospectus supplement and accompanying prospectus relating to the offering may be obtained from: Goldman Sachs & Co. LLC, at Prospectus Department, 200 West Street, New York, New York 10282, by telephone at 1-866-471-2526 or by email at [email protected]; and Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, California 94104, by telephone at 415-364-2720 or by email at [email protected].

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

On January 10, 2023 Agenus (NASDAQ: AGEN), an immuno-oncology company with a broad pipeline targeting cancer and infectious disease, reported that Dr. Garo Armen, Chairman and CEO of Agenus, and Dr. Steven O’Day, Chief Medical Officer, will participate in a virtual fireside chat at the B Riley Securities’ 2023 Virtual Oncology Conference on Wednesday, January 18th at 11:30am ET (Press release, Agenus, JAN 10, 2023, View Source [SID1234626161]).

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Registration for the webcast can be accessed at View Source Following the webcast, an archived version will be available on the Investors section of the Agenus website at View Source