Avid Bioservices Reports Financial Results for Fourth Quarter and Fiscal Year Ended April 30, 2021 and Recent Developments

On June 29, 2021 Avid Bioservices, Inc. (NASDAQ:CDMO), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, reported financial results for the fourth quarter and full fiscal year 2021, ended April 30, 2021 (Press release, Avid Bioservices, JUN 29, 2021, View Source [SID1234584455]).

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Highlights Since January 31, 2021

"Fiscal 2021 was a very strong year for Avid. During the year, revenues increased by 61% as compared to fiscal 2020 and gross margins were significantly improved from 7% to more than 30%. During fiscal 2021 we signed eight new customers, and during the fourth quarter we successfully completed FDA inspections for two product approvals with zero 483 observations. During fiscal 2021, we generated more than $31 million in cash from operations, and for the first time, we achieved four consecutive quarters of operational profitability. Beyond our operational successes, Avid’s financial position was significantly strengthened during the year by both new and existing investors who demonstrated support for Avid’s strategy through two separate offerings which were completed in the third and fourth quarters of fiscal 2021, raising combined net proceeds of $170.6 million. Further, as a sign of the momentum we have moving into the next year, we ended fiscal 2021 with a backlog of $118 million, the majority of which we expect to recognize during fiscal 2022. Given this backdrop, I am pleased to report that we expect to record revenue of between $115 million and $117 million in fiscal 2022, representing growth of approximately 20% – 22% as compared to fiscal 2021," stated Nicholas Green, president and chief executive officer of Avid Bioservices.

"The growth experienced during fiscal 2021 made it increasingly evident that an expansion of our capacity is required not only to best service our existing customers who are advancing products through the clinical development process toward commercialization, but to also maintain our competitive advantage in attracting new customers seeking capacity today. As discussed previously, Avid has initiated a two-phased expansion plan which was designed to bring incremental capacity online by the end of calendar 2021, and significantly more capacity in calendar 2022. I am very pleased to report that both phases are underway and advancing according to plan, and we look forward to reporting progress on this effort in the coming quarters. Given this work, it is important to note that our annual maintenance shutdowns that are usually conducted back-to-back in Q2, will be amended slightly this year with the Myford shutdown taking place in Q3 to accommodate our expansion schedule.

"Looking ahead into fiscal 2022, we expect these expansion investments, combined with ongoing investments in the recruitment, training and retention of our workforce, to result in a continued strengthening of our core business, opening doors to new opportunities for growth. Given the expectation of increasing demand, our additional planned capacity and a strong balance sheet, we will not only be able to best support additional customers working to develop mammalian drug products, but we look forward to strategically evaluating adjacent and/or strategic business expansions that may create value for Avid and our customers.

"The exceptional execution of our team during fiscal 2021 was transformative, bringing Avid to a position of operational and financial strength. We look forward to the many opportunities that lie ahead."

Financial Highlights and Guidance

The company is providing revenue guidance for the full fiscal year 2022 of $115 million to $117 million.

Revenues for the fourth quarter of fiscal 2021 were $27.6 million, more than double the revenues of $12.6 million recorded during the fourth quarter of fiscal 2020. For the full fiscal year 2021, revenues were $95.9 million, a 61% increase as compared to revenues of $59.7 million in the prior year period. The increases in revenue for both the fourth quarter and full fiscal year 2021 were primarily due to the growth in the number and scope of in-process and completed manufacturing runs, as well as an increase in the number of process development projects during the periods. Additionally, as previously disclosed, fourth quarter and full fiscal year 2020 manufacturing revenue was impacted by a production interruption.

As of April 30, 2021, revenue backlog was $118 million, an increase of 82% compared to $65 million at the end of last fiscal year. The company expects to recognize the majority of this backlog during fiscal 2022.

Gross margin for the fourth quarter of fiscal 2021 was 29% compared to a gross margin of negative 10% for the fourth quarter of fiscal 2020. Gross margin for the full fiscal year 2021 was 31% compared to 7% in the prior year period. The increases in gross margin during both the fourth quarter and full fiscal year 2021 were primarily from higher plant utilization resulting from higher manufacturing and process development revenues during the periods. Additionally, full fiscal year 2020 gross profit was impacted by certain costs associated with the production interruption noted above, which costs which did not recur during fiscal 2021.

Selling, general and administrative expenses ("SG&A") for the fourth quarter of fiscal 2021 were $5.1 million, an increase of 43% compared to $3.5 million recorded for the fourth quarter of fiscal 2020. For the full fiscal year 2021, SG&A expenses were $17.1 million, an 18% increase compared to $14.5 million for the prior year. The increases in SG&A during both the fourth quarter and full fiscal year 2021 were primarily due to increases in payroll related costs, including stock-based compensation.

During the fourth quarter of fiscal 2021, Avid redeemed its outstanding 10.5% Series E Convertible Preferred Stock. This redemption resulted in a one-time charge of $3.4 million, which was unrelated to operations, and recorded as a reduction to net income attributable to common stockholders. As a result, for the fourth quarter of fiscal 2021, the company recorded a net loss attributable to common stockholders of approximately $2.7 million or $0.04 per basic and diluted share, as compared to a net loss attributable to common stockholders of $6.2 million or $0.11 per basic and diluted share, for the fourth quarter of fiscal 2020. However, when adjusting for the one-time redemption charge, Avid would have recorded net income attributable to common stockholders of approximately $0.8 million, or $0.01 per basic and diluted share, during the fourth quarter of fiscal 2021, marking the company’s fourth consecutive quarter of net income attributable to common stockholders. For the full fiscal year 2021, the company recorded net income attributable to common stockholders of $3.3 million or $0.06 per basic and diluted share, compared to net loss attributable to common stockholders of $15.2 million or $0.27 per share, for fiscal 2020. Excluding the one-time redemption charge, Avid would have recorded net income attributable to common stockholders of approximately $6.8 million or $0.12 and $0.11 per basic and diluted share, respectively, for the full fiscal year 2021.

Avid reported $169.9 million in cash and cash equivalents as of April 30, 2021, an increase of $133.7 million from the end of the prior fiscal year. The increase in cash and cash equivalents as compared to fiscal 2020, is primarily due to $31.2 million generated from operations during the 2021 fiscal year, of which $17.9 million was generated during the fourth quarter. The fiscal 2021 balance also includes approximately $32.1 million in net proceeds which were raised during the third quarter in a follow-on underwritten equity financing, as well as approximately $138.5 million in net proceeds raised during the fourth quarter in an offering of 1.25% convertible senior notes.
More detailed financial information and analysis may be found in Avid Bioservices’ Annual Report on Form 10-K, which will be filed with the Securities and Exchange Commission today.

Recent Corporate Developments

Signed multiple new orders during the fourth quarter, totaling approximately $26 million. These projects span all areas of the business, from process development to commercial manufacturing. During fiscal 2021, the company signed new business orders for approximately $148 million as compared to $80 million during fiscal 2020. Additionally, the company signed eight new customers in fiscal 2021, a significant increase over fiscal 2020.

Completed an offering of 1.25% convertible senior notes during the fourth quarter, raising net proceeds of $138.5 million, after deducting initial purchaser discounts and other debt issuance related expenses. The company used approximately $12.8 million to purchase capped call transactions with certain financial institution counterparties in connection with the issuance of the convertible senior notes and approximately $40.5 million in April 2021 to redeem all of the company’s previously outstanding 10.5% Series E Convertible Preferred Stock. The company plans to use the remaining net proceeds for working capital and other general corporate purposes. The company may also use a portion of these funds for the acquisition of, or investment in, technologies, solutions or businesses that complement our existing capabilities, although it has no commitments to enter into any such acquisitions or investments at this time.

Two-part expansion of the Myford facility continues to progress according to plan. The first phase of the expansion, which was initiated during the second quarter of fiscal 2021, expands the production capacity of the company’s existing Myford North facility by adding a second downstream processing suite. The second phase, which was initiated during the fourth quarter of fiscal 2021, is designed to further expand capacity through the build out of a second manufacturing train, including both upstream and downstream processing suites within Myford South.

Combined, the company estimates that the first and second phases of this expansion will result in a total revenue generating capacity of up to $270 million annually. While the company believes that this expansion is critical to its ability to service the future needs of its customers, Avid presently has adequate capacity to accommodate current demand.
Conference Call

Avid will host a conference call and webcast this afternoon, June 29, 2021, at 4:30 PM EDT (1:30 PM PDT).

To listen to the conference call, please dial (877) 312-5443 or (253) 237-1126 and request the Avid Bioservices conference call. To listen to the live webcast, or access the archived webcast, please visit: View Source

MediciNova to Present at the Ladenburg Thalmann 2021 Virtual Healthcare Conference

On June 29, 2021 MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), reported that Yuichi Iwaki, MD, PhD, President and Chief Executive Officer, and Geoffrey O’Brien, JD/MBA, Vice President and Executive Officer, will present a corporate overview at the Ladenburg Thalmann 2021 Virtual Healthcare Conference on Tuesday, July 13, 2021 at 4:30 pm ET. MediciNova will be available for one-on-one meetings at this conference and investors may request a one-on-one meeting through Ladenburg Thalmann.

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Foundation Medicine and Flatiron Health Announce First-of-its-Kind Integration of Genomic Profiling Into OncoEMR®

On June 29, 2021 Foundation Medicine, Inc. reported it’s comprehensive genomic profiling (CGP) tests for their patients without leaving Flatiron Health’s OncoEMR platform (Press release, Foundation Medicine, JUN 29, 2021, View Source [SID1234584491]).

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This integration, the first of a series planned by Flatiron, will support more efficient clinical decision making by allowing electronic ordering, order tracking and receipt of Foundation Medicine’s CGP test results all within the OncoEMR platform. Almost all oncology practices use an electronic medical record (EMR) system to input, view and manage the full patient medical record in a single location, replacing a traditional paper chart with a digital one.1 EMR platforms also support clinical teams by enabling them to more efficiently order and track tests, view results, communicate treatment plans to patients and enable the completion of charting, documentation, and billing.

"With the number of targeted treatments growing exponentially, the opportunity for cancer care transformation has never been greater. Clinicians increasingly rely on genomic insights to guide clinical decision-making, and Foundation Medicine is committed to implementing new solutions that enable widespread access to CGP," said Kathleen Kaa, Interim Chief Commercial Officer at Foundation Medicine. "The integration of Foundation Medicine tests into OncoEMR, and other leading EMR systems to follow, is just one way we’re improving our offerings to fuel precision medicine for cancer patients. The integrations will create efficiencies for oncology healthcare teams to deliver precision treatment plans based on individual genomic insights to their patients."

"We are excited to welcome Foundation Medicine in the first of our planned CGP integrations with OncoEMR," said James Hamrick, MD, MPH, Vice President, Clinical Oncology at Flatiron Health. "This kind of integration marks an important milestone in advancing precision medicine, helping oncologists have access to the information they need to select therapies."

The two companies are planning similar integrations with other CGP platforms and EMRs, respectively, in the oncology space, with the goal of helping every patient to realize the benefit of precision cancer care. These workflow-streamlining integrations are being designed by clinical and product experts in partnership with oncology practices.

Trillium Therapeutics Announces Dosing of First Patient in Phase 1b/2 Study of TTI-621 in Combination With Doxorubicin in Leiomyosarcoma

On June 29, 2021 Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported that it has dosed the first patient with TTI-621 (SIRPα-IgG1 Fc), an investigational checkpoint inhibitor of the innate immune system, in combination with doxorubicin in a Phase 1b/2 study in leiomyosarcoma (LMS) (Press release, Trillium Therapeutics, JUN 29, 2021, View Source [SID1234584474]).

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TTI-621 binds CD47, an innate immune checkpoint that binds SIRPα and delivers a "don’t eat me" signal to suppress macrophage phagocytosis. Overexpression of CD47 can allow tumor cells to escape immune surveillance. TTI-621 is a fusion protein consisting of the CD47 binding domain of SIRPα linked to the Fc region of human IgG1. It is designed to enhance phagocytosis and tumor cell destruction by blocking the CD47-SIRPα interaction and delivering an activating ("eat me") signal to macrophages. The IgG1 backbone can also activate NK cell-mediated anti-tumor activity. Published preclinical studies suggest that anti-CD47 agents may exhibit anti-tumor activity against LMS cells.

"The dosing of this patient marks the beginning of the first Phase 1b/2 solid tumor clinical trial for Trillium," commented Dr. Ingmar Bruns, Trillium’s Chief Medical Officer. "We’re committed to exploring solid tumors and build upon our potentially best-in-class initial hematologic malignancy datasets."

For newly diagnosed LMS patients, doxorubicin is considered part of standard of care. In this open-label Phase 1b/2 study, Trillium is adding TTI-621 to frontline doxorubicin and enrolling approximately 60 newly diagnosed LMS patients. The primary endpoints are safety and overall response rate.

"Metastisized LMS, the most common form of soft tissue sarcoma, is a serious disease with significant unmet need. We believe that the combination of TTI-621 and doxorubicin has the potential to provide benefit for these patients where few therapeutic options exist," added Dr. Bruns.

Ixaka and SomaLogic Enter Research Collaboration to Develop Bispecific Agents for Oncology

On June 29, 2021 Ixaka Ltd and SomaLogic reported a research collaboration to support the development of aptamer-based bispecific therapeutics (Press release, Ixaka, JUN 29, 2021, View Source [SID1234584492]).

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The collaboration will evaluate the safety and efficacy of antigen-specific SOMAmer reagents (modified aptamers that bind tightly and specifically to protein targets) previously identified and screened by SomaLogic as potential candidates for combination with Ixaka’s anti-CD3 aptamers.

Ixaka is currently developing in vivo CAR-T therapies using its in vivo gene delivery technology, which facilitates in vivo targeting and transduction of patient T cells. The universal in vivo gene modification approach relies on proprietary anti-CD3 aptamers selected by Ixaka as targeting agents, which have been applied to engineer aptamer-based BiTEs (Bi-specific T-cell engagers).

SomaLogic’s antigen-specific SOMAmer reagents will now be evaluated with the intention of improving both the safety and efficacy of antibody-based bispecifics. This follows a recent in vitro proof-of-concept study that successfully highlighted the potential of Ixaka’s cancer specific antigenxCD3 bispecific aptamers as new anticancer agents that can recruit cytotoxic T cells and induce killing of tumor cells.

Cecile Bauche, Vice President and Chief Scientific Officer at Ixaka, commented: "We have made great progress with our anti-CD3 aptamer candidate, with recent positive data demonstrating in vitro proof of concept when combined with a cancer-specific antigenic aptamer. SOMAmer molecules are a promising new class of drug entities with the potential to accelerate development of our aptamer-based BiTEs as anti-cancer agents and help us in our mission to offer new and effective treatments for cancer."

Renaud Vaillant, Vice President, Business Development at Ixaka, commented: "We have been working with aptamers as potential immunotherapies since the inception of the company. We first engaged in discussion with SomaLogic 4 years ago, when the project was just an idea as part of a presentation. I am proud and excited to finally start this collaboration, which is a result of the tremendous work achieved by our team."

In the collaboration, SomaLogic will provide SOMAmers for screening and subsequent evaluation of in vitro cytotoxic properties. Ixaka will lead the experiments to identify and evaluate SOMAmer candidates with high affinity and specificity. Further work will determine functional in vitro properties of bispecific aptamers in human cell cultures and evaluate in vivo anticancer efficacy in murine models.

Nebojsa Janjic, Chief Science Officer of SomaLogic, commented: "The ability of SOMAmer reagents to bind with high specificity and affinity to any target protein makes them ideal for the development of novel therapies for oncology. We hope to expand this collaboration with Ixaka in the future to support new treatments for other therapeutic areas."

SomaLogic’s anti-tumoral SOMAmers demonstrate potential utility as the chemical addition of ‘protein-like’ side chains to the nucleic acid bases that comprise a SOMAmer can be used to develop molecules with high specificity and affinity for any targeted protein, making SOMAmer candidates attractive for novel therapeutic development.

The first application of Ixaka’s TNP technology is the generation of CAR T-cell therapies for haematological malignancies. However, modification of the components offers the potential to target a broad range of therapeutic cells for the treatment of many serious diseases, including cancers, genetic disorders, neurological and ocular diseases.