Alvotech and Oaktree Acquisition Corp. II Announce Merger Agreement to Create a Leading Publicly-Traded Global Biopharmaceutical Company

On December 7, 2021 Alvotech Holdings S.A. ("Alvotech"), a leading global biopharmaceutical company focused solely on the development and manufacture of biosimilar medicines for patients worldwide, and Oaktree Acquisition Corp. II (NYSE: OACB.U, OACB, OACB WS), a special purpose acquisition company sponsored by an affiliate of Oaktree Capital Management, L.P. ("Oaktree"), reported that they have entered into a definitive merger agreement. Upon completion of the transaction, the combined company’s securities are expected to be traded on NASDAQ under the symbol "ALVO (Press release, Alvotech, DEC 7, 2021, View Source [SID1234596548])."

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Company Overview

Alvotech, founded in 2013 in Reykjavik, Iceland, is a vertically integrated platform company focused exclusively on developing and manufacturing biosimilar medicines for the global market. Alvotech has a world class management team of proven and highly experienced pharmaceuticals executives with deep expertise in biologics and biosimilars, led by a visionary founder, Robert Wessman, who has a track record of building global biopharmaceutical companies.

Alvotech is dedicated to transforming patients’ lives by improving access to affordable biosimilar medicines and enhancing the sustainability of healthcare systems. A biosimilar medicine, offered at lower costs, is a biological product that is highly similar to and has no clinically meaningful difference from an existing approved biologic. Biologics are large complex molecules that have become the standard of care for many difficult-to-treat conditions. The global markets for biologic and biosimilar medicines have been rapidly growing over the last decade and are forecasted to grow at a 10%+ CAGR, reaching approximately $555 billion and approximately $80 billion by 2026, respectively1. By establishing the critical infrastructure needed to navigate the complexities inherent in developing biosimilar medicines at a global scale, Alvotech is uniquely positioned to succeed in the rapidly growing biosimilars market and to enable the global healthcare system to reduce the high cost of biologic medicines.

Alvotech aims to become a leading supplier of biosimilar medicines in all major markets around the world. To accomplish this objective, Alvotech has built a distinctive and comprehensive platform for developing and manufacturing biosimilars at scale over the past nine years with approximately $1 billion invested into the business to build critical elements of product development, including cell line development, process development and characterization, in addition to manufacturing, clinical development and conducting regulatory affairs, in-house to ensure the highest standards of product quality.

Alvotech currently has seven products in its pipeline across multiple therapeutic areas. Alvotech’s pipeline addresses originator products treating a diverse set of conditions across autoimmunity, ophthalmology, osteoporosis, and oncology, with total estimated peak originator sales of more than $80 billion combined.

Alvotech’s most advanced product is AVT02, the company’s biosimilar candidate to Humira. Humira is the world’s top selling pharmaceutical product with over $20 billion in global revenue in 2020. Alvotech was the first company to both file with the FDA for approval of its high-concentration adalimumab product and to have successfully conducted a switching study in support of an FDA designation of interchangeability. Alvotech’s other differentiated pipeline programs include biosimilar candidates to Stelara (ustekinumab), Eylea (aflibercept), Prolia/Xgeva (denosumab) and Simponi/Simponi ARIA (golimumab). In addition to its existing pipeline, Alvotech is also constantly evaluating new pipeline programs, both internally and through business development.

In order to give its products global reach, Alvotech has formed strategic commercialization partnerships covering 60+ countries with leading pharmaceutical companies. Alvotech’s partners, including Teva in the US and Stada in the EU, have licensed products in exchange for milestone payments and royalties. As of June 30, 2021, Alvotech had received license fee commitments of up to $1.15 billion under these partnerships, approximately 80% of which are still to be collected.

Management Comments

"We are delighted with this business combination and the long-term opportunities it will unlock for Alvotech," said Robert Wessman, Chairman and founder of Alvotech. "Through this important milestone, we believe that we are perfectly positioned to rapidly scale our portfolio with a like-minded partner who understands the intricacies of our business and our industry."

Howard Marks, Co-Chair of Oaktree, added, "Oaktree Acquisition Corp.’s strategy is guided by the same principles that are core to Oaktree’s broader investment philosophy, with a focus on long-term partnership and value creation. The Oaktree Acquisition Corp. franchise was formed to identify and partner with high-quality, growing companies that are making pivotal strides in their respective industries, and Alvotech is a clear fit with its meaningful contributions to sustainability within the healthcare ecosystem."

"Alvotech has built a highly attractive platform with a long-term view to lead the biosimilars market," said Zaid Pardesi, Managing Director at Oaktree and CFO & Head of M&A of Oaktree Acquisition Corp II. "The Company’s diverse pipeline and unique capabilities, in combination with its world-class distribution partners, set the stage for meaningful value creation and accelerated growth going forward."

Mark Levick, CEO of Alvotech, added, "Alvotech is in a unique position to impact the global healthcare ecosystem in a positive way and transform patient’s lives. Biosimilar medicines can increase access for patients whilst lowering cost for healthcare systems, and that helps to align our mission with all of our stakeholders. We believe this transaction will accelerate our ability to achieve our vision, and we could not be more excited about what the future holds for Alvotech."

Key Transaction Terms

The business combination is expected to deliver gross proceeds to Alvotech in excess of $450 million (assuming no redemptions). This includes cash proceeds of approximately $250 million from Oaktree Acquisition Corp. II’s trust account (assuming no redemptions); in excess of $150 million from private placement (PIPE) investors (the "PIPE Transaction"), including among others, funds managed by Suvretta Capital, Athos (the Strüngmann Family Office), CVC Capital Partners, Temasek, Farallon Capital Management, Sculptor Capital Management and premier Icelandic investors including Arctica Finance, Arion Bank, and Landsbankinn; and a $50 million equity commitment from existing shareholders to be funded prior to the end of 2021. The combined company will have an implied initial enterprise value of approximately $2.25 billion and will be well-positioned to continue investing in the growth of its biosimilar pipeline.

As part of the transaction, Alvotech’s existing equity holders have committed to roll 100% of their equity into the combined company. Leading existing institutional backers of Alvotech, including among others, Aztiq Pharma Partners, led by founder and Chairman Mr. Robert Wessman, Alvogen with CVC Capital Partners and Temasek as lead investors, Fuji Pharma from Japan, YAS Holdings from Abu Dhabi, Shinhan from Korea, Baxter Healthcare SA from the US, and Athos (the Strüngmann Family Office) from Germany intend to roll 100% of their shares into the combined company. Assuming no public shareholders of Oaktree Acquisition Corp. II exercise their redemption rights, current Alvotech equity holders will own approximately 80%, Oaktree Acquisition Corp. II shareholders will own approximately 11%, and PIPE investors will own approximately 7% of the issued and outstanding ordinary shares, respectively, of the combined company at closing.

The transaction also includes earn-out provisions tied to the trading price of the combined company’s shares, reflecting an alignment of interest with shareholders. Oaktree Acquisition Corp. II’s sponsor is deferring 1.25 million founder shares into an earn-out at share price hurdles of $12.50 and $15.00. The transaction also includes an earn-out to existing shareholders of Alvotech, consisting of 38.3 million shares, which will vest evenly at share price hurdles of $15.00 and $20.00.

The transaction, which has been unanimously approved by the boards of directors of each Alvotech and Oaktree Acquisition Corp. II, is subject to, among other customary closing conditions, approval by shareholders of Oaktree Acquisition Corp. II, and shareholders of Alvotech, with the holders of a majority of the votes required to approve the transaction having provided commitments to approve the transaction. The transaction is expected to close in the first half of 2022.

A more detailed description of the transaction terms and a copy of the Business Combination Agreement will be included in a current report on Form 8-K to be filed by Oaktree Acquisition Corp. II with the United States Securities and Exchange Commission (the "SEC"). Oaktree Acquisition Corp. II will file a registration statement (which will contain a proxy statement/ prospectus) with the SEC in connection with the transaction.

Advisors

Morgan Stanley & Co. LLC and Credit Suisse served as financial advisors to Alvotech. Deutsche Bank Securities served as financial advisor and capital markets advisor to Oaktree Acquisition Corp. II. Deutsche Bank Securities and Morgan Stanley & Co. LLC served as lead private placement agents, and Citigroup Global Markets Inc. and Credit Suisse also served as private placement agents, for Oaktree Acquisition Corp. II in connection with the PIPE Transaction. Cooley (UK) LLP served as lead legal counsel to Alvotech. Kirkland and Ellis LLP and King & Spalding served as legal counsel to Oaktree Acquisition Corp. II. Shearman & Sterling LLP served as legal counsel to the placement agents.

Management Presentation

A presentation made by the management teams each of Alvotech and Oaktree Acquisition Corp. II regarding the transaction will be available on the websites of Oaktree Acquisition Corp. II at View Source and Alvotech at View Source Oaktree Acquisition Corp. II will also file the presentation and transcript of related remarks with the SEC as an exhibit to a Current Report on Form 8-K, which can be viewed on the SEC’s website at www.sec.gov.

Privo Technologies, Inc. To Attend Biotech Showcase 2022

On December 7, 2021 Privo Technologies, Inc. ("Privo"), a biopharmaceutical company focused on optimizing state-of-the-art chemotherapies to be "Tough on cancer, Easy on patients", reported that the Company will be attending the virtual Biotech Showcase from January 17 to January 19, 2022 (Press release, Privo Technologies, DEC 7, 2021, View Source;utm_medium=rss&utm_campaign=privo-technologies-inc-to-attend-biotech-showcase-2022 [SID1234596547]). Members of Privo’s management team will be available for 1×1 meetings with interested parties. Those registered for the event can request a meeting with Privo through the partneringOne portal.

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Privo Technologies, Inc. To Attend 2022 Bio Partnering at JPM

On December 7, 2021 Privo Technologies, Inc. ("Privo"), a clinical-stage biopharmaceutical company focused on optimizing state-of-the-art chemotherapies to be "Tough on cancer, Easy on patients", reported that senior management will be virtually attending BIO Partnering at JPM from January 10 to January 14, 2022 (Press release, Privo Technologies, DEC 7, 2021, View Source;utm_medium=rss&utm_campaign=privo-technologies-inc-to-attend-2022-bio-partnering-at-jpm [SID1234596546]). Those looking to meet with Privo can schedule a 1×1 meeting through the BIO One-on-One Partnering portal.

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Iovance Biotherapeutics to Present at Upcoming Conferences

On December 7, 2021 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported participation in the following conferences in December (Press release, Iovance Biotherapeutics, DEC 7, 2021, View Source [SID1234596545]):

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The JMP Securities Hematology and Oncology Summit
Fireside Chat: Tuesday, December 7 at 1:40 p.m. ET
Live and archived webcast available at View Source
ESMO Immuno-Oncology Annual Meeting, December 8-11, 2021, Geneva, Switzerland
AKT inhibition during ex vivo TIL expansion enhances cytokine production and function while increasing the population of less differentiated (CD39-CD69-) CD8+ T-Cells
On-Demand Poster
The poster is available at View Source." target="_blank" title="View Source." rel="nofollow">View Source
American Society of Hematology Annual Meeting, December 11-14, Atlanta, Georgia
Trial in Progress: Phase 1/2 Study Evaluating the Safety and Efficacy of IOV-2001, an Autologous, Non-Genetically Modified, Polyclonal T-Cell Product, in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) (IOV-CLL-01)
Poster Presentation: Monday, December 13 at 6:00 p.m. ET
The poster will be available at View Source at the start of the session.

Pacira BioSciences Reports Preliminary Net Product Sales for EXPAREL® and iovera° of $48.0 Million for November 2021

On December 7, 2021 Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, reported preliminary unaudited net product sales for EXPAREL (bupivacaine liposome injectable suspension) and iovera° for the month of November 2021 (Press release, Pacira Pharmaceuticals, DEC 7, 2021, View Source [SID1234596543]). EXPAREL net product sales were $46.5 million, compared with $38.1 million for November 2020. EXPAREL average daily sales for the month of November 2021 were 122 percent of November 2020. The company reports average daily growth rates for EXPAREL to account for differences in the number of selling days per reporting period. The number of EXPAREL selling days were 20 in both November 2021 and November 2020. Net product sales of iovera° were $1.5 million for the month of November 2021, compared with $0.8 million for November 2020.

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"We are encouraged by EXPAREL’s robust growth in November with product utilization continuing to significantly outpace the recovery of the elective surgery market," said Dave Stack, chairman and chief executive officer of Pacira BioSciences. "Our team is driving strong results while at the same time advancing integration activities from the Flexion acquisition. We look forward to the significant opportunity and synergies we believe ZILRETTA will add to our commercial offering in 2022 and beyond. As we close out 2021, we look forward to delivering strong top- and bottom-line growth as we build upon our mounting momentum and leadership in non-opioid pain management to improve patient care along the neural pain pathway."

On November 19, 2021, Pacira completed its acquisition of Flexion Therapeutics, which added ZILRETTA (triamcinolone acetonide extended-release injectable suspension) to its commercial offering. Pacira is currently not reporting preliminary monthly ZILRETTA net product sales as the required adjustments for certain product rebate programs are calculated after the end of the quarter and, as a result, ZILRETTA net product sales for the months of November 2021 and 2020 are not included in the amounts above. In addition to pandemic-related challenges, Flexion previously reported that its sales were negatively impacted in the third quarter of 2021 by rebate program modifications and several unanticipated manufacturing batch failures that led to short-dated ZILRETTA inventory resulting in smaller order sizes and product returns. Pacira expects to exit 2021 with ZILRETTA quarterly sales tracking more in line with ZILRETTA second quarter of 2021 sales with sales trends improving thereafter as Pacira extends inventory dating, simplifies the rebate program, and completes integration activities in 2022.

The company’s net product sales were negatively impacted by the COVID-19 pandemic in 2020 due to the significant postponement or suspension in the scheduling of elective surgical procedures resulting from public health guidance and government directives. Elective surgery restrictions began to lift on a state-by-state basis in April 2020, allowing EXPAREL sales to return to year-over-year growth in June 2020. However, while many restrictions have since eased and COVID-19 vaccines have become more widely available and administered to the general public, it is still unclear how long it will take the elective surgery market to normalize, or if restrictions on elective procedures will recur due to COVID-19 variant strains or otherwise.

The company has not provided 2021 financial guidance given the continued uncertainty around COVID-19 and the pace of recovery for the elective surgery market. To provide greater transparency, Pacira is reporting monthly intra-quarter unaudited net product sales for EXPAREL and iovera° and will continue to do so until it has gained enough visibility around the impacts of COVID-19. The company is also providing weekly EXPAREL utilization and elective surgery data within its investor presentation, which is accessible at investor.pacira.com.

The financial information included in this press release is preliminary, unaudited, and subject to adjustment. It does not present all information necessary for an understanding of the company’s financial results for the fourth quarter or full year 2021.