On April 13, 2022 Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") and Antares Pharma, Inc. (NASDAQ: ATRS) ("Antares") reported that the companies have entered into a definitive agreement pursuant to which Halozyme will acquire Antares for $5.60 per share in cash (Press release, Halozyme, APR 13, 2022, View Source [SID1234612146]). The transaction, which values Antares at approximately $960 million, was unanimously approved by both the Halozyme and Antares Boards of Directors.

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The transaction is expected to be immediately accretive to Halozyme’s 2022 revenue and non-GAAP earnings and to accelerate top- and bottom-line growth through 2027, with multiple growth drivers beyond 2027. The combination of Halozyme and Antares will create a leading drug delivery and specialty product company. The Antares business consists of a best-in-class, differentiated, royalty revenue generating auto injector platform business that offers broad licensing opportunity, and a commercial business, with three proprietary commercial products.

"The addition of Antares, particularly with its best-in-class auto injector platform and specialty commercial business, augments Halozyme’s strategy, further strengthens our position as a leading drug delivery company and extends our strategy to include specialty products," said Dr. Helen Torley, president and chief executive officer of Halozyme. "The acquisition of Antares fits well with our previously discussed strategic priorities and provides substantial financial growth potential and disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme is well-positioned to leverage Antares’ value proposition, driven by a strong balance sheet, established industry relationships and business development experience. We look forward to welcoming Antares’ talented team as we embark on our next chapter of accelerating financial growth, maximizing patient benefit, and enhancing value."

Robert F. Apple, president and chief executive officer of Antares, commented, "We are pleased to have reached this agreement with Halozyme, as this transaction showcases the value of Antares’ highly complementary business, provides our shareholders with attractive and certain value, and brings together industry-leading expertise and drug delivery platforms to accelerate growth and create new opportunities. As we remain committed to continuing to serve our partners, I would like to thank our

employees for their hard work and dedication to this mission. We look forward to working with the Halozyme team to complete the transaction and deliver best-in-class therapies and drug delivery solutions."

Compelling Financial and Strategic Benefits

Immediate Revenue and Non-GAAP Earnings Accretion and Long-Term Financial Upside: The transaction is expected to be immediately accretive to Halozyme’s 2022 revenue and non-GAAP earnings, supported by Antares’ proprietary product revenues, royalty revenues and profitability. The addition of Antares is also expected to accelerate top- and bottom-line growth and enhance cash flow generation through 2027, increasing Halozyme’s flexibility to pursue further growth drivers in the forms of new product and therapy launches, and partnerships.

Business Development to Augment Long-Term Growth, Consistent with Strategic Priorities: The addition of Antares’ commercial products and existing auto injector capabilities accelerate Halozyme’s strategy to drive long-term, durable revenue growth and value creation through focused external growth. Halozyme expects to build on Antares’ core platform technology and capabilities to drive incremental, durable revenue opportunities with additional intellectual property protections for Antares technology in place beyond 2030.

Substantial Market Expansion Opportunity in High Revenue Segments: Antares’ successful development and partnership of its technology platforms offers a widely licensable product suite that can be broadly applied across a spectrum of market segments representing multiple tens of billions of dollars1 in estimated peak sales. This includes the potential for conversion to both high-viscosity and high-volume auto injector devices, supported by Halozyme’s extensive infrastructure and commercially validated ENHANZE platform technology.

High Growth, Durable Commercial Franchise with Proven Track Record: Antares’ suite of FDA-approved, high quality commercial products and partner products utilizing the Antares auto injector technology have already demonstrated commercial success and are positioned for long-term growth. Launch of Tlando will leverage existing testosterone commercial infrastructure and capabilities in a growing therapeutic category, building on momentum created by Xyosted’s success.

Two Highly Complementary Platforms, Each with Meaningful Pipelines: Antares’ broadly applicable, differentiated auto injector platform is suitable for use with a broad range of medications. The versatility of this platform enables a highly licensable business with significant revenue upside. The combined entity will be able to leverage its deep industry expertise and existing commercial infrastructure in the U.S. to expand delivery capabilities and pursue growth opportunities within multiple small- and large-molecule products.

Transaction Terms, Financing and Time to Closing

Under the terms of the merger agreement, Halozyme will commence a cash tender offer to acquire all

of the outstanding shares of Antares for $5.60 per share in cash. The transaction is not subject to a financing condition. Halozyme intends to finance the transaction using existing cash on hand and new sources of debt. Following completion of the transaction, Halozyme expects to maintain a strong balance sheet with less than 3.5x net debt-to-EBITDA ratio at the time of transaction close. Net debt-to-EBITDA ratio is expected to decline significantly in the quarters post transaction close. The closing of the tender offer will be subject to certain conditions, including the tender of shares representing at least a majority of the total number of Antares’ outstanding shares of common stock, the expiration or termination of the HSR waiting period, and other customary conditions. Following the successful completion of the tender offer, Halozyme will acquire all remaining shares not tendered in the tender offer through a second-step merger at the same price. This transaction is expected to close in the first half of 2022.

BofA Securities and Wells Fargo Securities LLC are acting as financial advisors to Halozyme and Weil, Gotshal & Manges LLP is acting as legal advisor. Jefferies LLC is acting as financial advisor to Antares and Skadden, Arps, Slate, Meagher & Flom LLP is acting as legal advisor.

Business Update

Halozyme reaffirms its 2022 guidance and its commitment to the three year $750 million share repurchase program.

Conference Call

Halozyme will host a conference call and a simultaneous webcast to discuss the transaction today, Wednesday, April 13, 2022 at 8:00 a.m. ET/5:00 a.m. PT. Dr. Torley will lead the call, which will be webcast live through the "Investors" section of Halozyme’s corporate website and a webcast replay will be available following the close of the call. To register for this conference call, please use this link: View Source After registering, you will receive an email confirmation that includes dial in details and unique conference call codes for entry. Registration is open through the live call.

On April 13, 2022 Oncocyte Corporation (Nasdaq: OCX), ("Oncocyte" or the "Company"), a precision diagnostics company with the mission to improve patient outcomes by providing personalized insights that inform critical decisions throughout the patient cancer care journey, reported the pricing of a registered direct offering of 11,765 shares of its Series A Convertible Preferred Stock (the "Preferred Stock") with institutional investors (Press release, Oncocyte, APR 13, 2022, View Source [SID1234612145]). The shares of Preferred Stock are convertible into a total of 7,689,542 shares of our common stock, at a conversion price of $1.53. The Preferred Stock will bear a dividend of 6% per annum and is required to be redeemed by the Company, if not converted, on April 8, 2024. Gross proceeds from the offering are expected to be approximately $10 million, before deducting offering expenses. There is no established public trading market for the Preferred Stock and we do not intend to apply for listing of the Preferred Stock on any national securities exchange or expect a market to development.

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Oncocyte intends to use the net proceeds from the offering primarily to promote commercialization of DetermaRx, including sales and marketing efforts and by conducting additional clinical studies to support clinical adoption of the test; to complete development of DetermaIO; for development of other future tests in our pipeline, including DetermaCNI, DetermaTx and DetermaMx. We expect to use net proceeds to pay for development costs associated with our activities under our Collaboration Agreement with Life Technologies Corporation, or LTC, a subsidiary of Thermo Fisher Scientific, pursuant to which we have agreed to undertake certain development efforts with LTC and to collaborate with LTC in the commercialization of Thermo Fisher Scientific’s existing Oncomine Comprehensive Assay Plus, and our DetermaIO assay for use with LTC’s Ion TorrentTM Genexus Integrated Sequencer and LTC’s Ion Torrent Genexus Purification System, in order to obtain in vitro diagnostic regulatory approval of those tests. We may also use net proceeds to make certain future milestone and other payments to former shareholders of companies that we have acquired, including Chronix Biomedical, Inc. and Insight Genetics, Inc. if the applicable milestones requiring such payments are met.

A shelf registration statement on Form S-3 (Registration No. 333-256650) relating to the securities being offered was filed with the Securities and Exchange Commission ("SEC") and was declared effective on June 8, 2021. The offering will be made only by means of a prospectus supplement and accompanying prospectus. A prospectus supplement relating to the offering will be filed with the SEC and will be available for free on the SEC’s website located at View Source

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. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement.

On April 13, 2022 Autigen, a biotechnology portfolio company of the pharmaceutical accelerator, Ascend BioVentures, developing novel treatments for hearing loss, reported that it has signed a research collaboration and license agreement with Boehringer Ingelheim to discover, develop, and commercialize transformative therapies for patients with SNHL (Press release, Boehringer Ingelheim, APR 13, 2022, View Source [SID1234612144]).

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About 430 million people suffer from moderate to complete hearing loss worldwide, a number expected to rise to about 700 million by 2050. Hearing loss can significantly impact multiple aspects of life, including the loss of the ability to follow spoken conversations. Hearing loss contributes to increased risk of dementia and cognitive decline. Deafness in early life, if left unaddressed, is associated with poor development of spoken language and higher unemployment rates in later life. In addition, hearing loss represents a significant psychological burden such as loneliness, isolation, depression, and anxiety.

SNHL, which can eventually lead to deafness, accounts for about 90% of reported hearing loss cases and is related to a degeneration of sensory hair cells (HC) in the inner ear.

"We are excited to enter this collaboration with Boehringer-Ingelheim, an innovation-led company with a strong commitment to developing breakthrough regenerative and hearing loss therapies." said Elaine Hamm, Ph.D., President, Autigen and CEO of Ascend BioVentures. "This collaboration advances our leadership position in novel therapies for sensorineural hearing loss (SHNL), an approach that Autigen and our collaborators at the Hough Ear Institute, have pioneered. It marks the first major licensing partnership out of our pharmaceutical accelerator, Ascend BioVentures and will enable Autigen to advance its novel therapy approach to restore SHNL for patients, who currently have no approved pharmacological or biological treatment options."

Under the terms of the agreement, Autigen will receive an undisclosed upfront payment and research funding support. The company is also eligible to receive future success-based milestone payments of a total potential value of more than $100M if all milestones are achieved over the course of the partnership. Autigen is also eligible for royalties on products derived from the partnership. After a joint research collaboration phase, Boehringer Ingelheim will be responsible for further preclinical and clinical development, and commercialization.

On April 13, 2022 Microba Life Sciences (ASX:MAP), a precision microbiome science company, reported that trading on the Australian Securities Exchange (ASX) on April 4th following the completion of an initial public offering (IPO) (Press release, Biosortia Pharmaceuticals, APR 13, 2022, View Source [SID1234612143]).

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The IPO raised $30.0 million and was supported by institutional, professional and retail investors. Bell Potter Securities Limited and Canaccord Genuity (Australia) Limited were Joint Lead Managers and Underwriters to the IPO.

NYSE listed synthetic biology company Ginkgo Bioworks (NYSE: DNA) invested USD $3.5m into Microba IPO, becoming a ~4% shareholder of the Company with which Microba also signed a therapeutic development agreement to identify single-strain, live biotherapeutics product (LBP) candidates against autoimmune diseases. The collaboration aims to build on Microba’s precision approach to LBP development with an in-depth evaluation of the company’s strains using Ginkgo’s high throughput, automated screening capabilities.

The Company’s strategy is to partner or license therapeutic assets with large pharmaceutical companies early in clinical development in return for upfront, milestone and royalty payments. The Offer will enable Microba to accelerate the growth of its Services and Therapeutics business and further develop its platform technology:

• Microbiome Services – Microba is an established leader in microbiome testing with over 20,000 test reports sold to date. New major distribution partnerships including SYNLAB (EU), Genova Diagnostics (US), and G42 (Middle East) accelerate growth with multiple products scheduled for launch.

• Proprietary Databank – a large, unique, proprietary microbiome Databank comprising of over 1.2 million microbial genomes. Microba’s Databank has enabled the Company to identify novel therapeutic leads not identified by others.

• Microbiome Therapeutics – Microba leverages its growing Databank through a repeatable Therapeutics Platform to develop novel microbiome therapeutics. Microba has established multiple therapeutic programs, including for Inflammatory Bowel Disease with a Phase 1 clinical trial planned to commence in late 2022.

"We believe the human microbiome currently represents a missing piece in the treatment of major chronic diseases, and as a result a number of microbiome-based therapeutics are progressing through clinical development globally"

said Luke Reid, CEO at Microba.

"Ginkgo’s high throughput screening automation combined with our novel data-driven approach to therapeutic discovery from the microbiome can potentially accelerate development of breakthrough new drugs for autoimmune diseases."

Through this partnership, Ginkgo will provide high-throughput screening for Microba’s proprietary library of human microbiome-isolated strains, with the goal of improving treatment for autoimmune diseases such as lupus, psoriatic arthritis and certain autoimmune liver diseases. Microba plans to leverage Ginkgo’s high-throughput anaerobic culturing, multi-omics data collection and analysis, functional bioassay screening, and media and fermentation optimization capabilities to generate data sets that may help characterize potential therapeutic and non-therapeutic uses of the strains. The initial partnership combining Microba’s biobank and Ginkgo’s anaerobic development capabilities is expected to run approximately two years.

"Microba is doing truly innovative work during an exciting time for the field of microbiome science,"

said Jennifer Wipf, Senior Vice President, Commercial Cell Engineering of Ginkgo.

"We’re happy to welcome new partners like Microba as we apply our platform to more applications in the living therapeutics and microbiome space."

On April 13, 2022 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported its Annual Report on Form 10-K and reported final audited financial results for the fourth quarter and full year ended December 31, 2021 (Press release, Supernus, APR 13, 2022, View Source;2022.htm [SID1234612142]).

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On February 28, 2022, the Company announced preliminary unaudited results for the fourth quarter and full year ended December 31, 2021. This press release updates and supersedes the press release issued on February 28, 2022 as a result of the filing of the Company’s audited year-end financial statements.

In completing its year-end financial statements, one change relating to non-recurring acquisition-related costs associated with the acquisition of Adamas Pharmaceuticals, Inc. (Adamas) was made to the preliminary unaudited results. This change and the resulting final audited results are in the table below:

As compared to the preliminary unaudited results, combined R&D and SG&A expenses increased by approximately $15.6 million and final operating earnings was reduced by that amount, in each case, for the three and twelve months ended December 31, 2021. The final audited results do not include any other changes from the 2021 preliminary unaudited information included in the February 28, 2022 press release. Detailed final audited results for the period ended December 31, 2021, can be found at the end of this release.

Non-GAAP operating earnings adjust for non-cash items including share-based compensation expense, depreciation and amortization, and accretion of contingent consideration, and for non-recurring costs. Acquisition-related costs reflect non-recurring acquisition-related costs related to the Adamas acquisition. Other R&D reflects a non-cash expense related to the equity investment in Navitor due to the accounting impact of the March 2021 Navitor corporate restructuring. Included in the amortization of intangible assets is amortization of acquired intangible assets from the Adamas acquisition in November 2021.

Full Year 2022 Financial Guidance — GAAP to Non-GAAP Adjustments

An itemized reconciliation between projected operating earnings on a GAAP basis and projected operating earnings on a non-GAAP basis is as follows:

Non-GAAP Financial Information

This press release contains a financial measure, non-GAAP operating earnings, which does not comply with United States generally accepted accounting principles (GAAP). The non-GAAP financial measure should be considered in addition to, not as a substitute for or in isolation from, or superior to measures prepared in accordance with GAAP. Non-GAAP operating earnings adjust for non-cash share-based compensation expense, depreciation and amortization, and accretion of contingent consideration, and for factors that are unusual, non-recurring or unpredictable, and exclude those costs, expenses, and other specified items presented in the reconciliation tables in this press release. We believe the use of non-GAAP operating earnings measure is useful supplemental information to investors regarding the Company’s results of operations and assist management, analysts, and investors in evaluating the performance of the business. There are limitations associated with the use of non-GAAP financial measure. Including such measure may not be entirely comparable to similarly titled measures used by other companies, may not reflect all items of income and expense, as applicable, that affect our operations, potential differences among calculation methodologies, may differ from the non-GAAP information used by other companies, including peer companies, and therefore comparability may be limited. We mitigate these limitations by reconciling the non-GAAP financial measures to the most comparable GAAP financial measures. Investors are encouraged to review the reconciliation. The Company’s 2022 financial guidance is also being provided on both a reported and a non-GAAP basis.