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

Iovance Biotherapeutics Announces Clinical Data for LN-145 in Non-Small Cell Lung Cancer

On June 29, 2021 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported clinical data for its tumor infiltrating lymphocyte (TIL) therapy LN-145 in patients with metastatic non-small cell lung cancer (mNSCLC) who enrolled in Cohort 3B of the ongoing basket study IOV-COM-202 (Press release, Iovance Biotherapeutics, JUN 29, 2021, View Source [SID1234584453]). Cohort 3B enrolled patients that had progressed on prior immune checkpoint inhibitor (ICI) therapy, including patients with oncogene-driven tumors who received prior tyrosine kinase inhibitor therapy. The initial clinical results are available in a slide presentation on the Iovance website here.

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The overall response rate (ORR) by investigator per RECIST 1.1 was 21.4% (n=28, one complete response and five partial responses) and the disease control rate (DCR) was 64.3% following one-time treatment with LN-145 monotherapy, including two responders with PD-L1 negative tumors. Median duration of response was not reached at a median study follow up of 8.2 months. The treatment-emergent adverse event profile was consistent with the underlying disease and known adverse event profiles of non-myeloablative lymphodepletion and IL-2. All patients treated in Cohort 3B received prior anti-PD-1/L1 therapy and all six responding patients also received prior chemotherapy. Historically, ORRs of approximately 20% were reported with ICIs as second-line therapy in ICI-naïve patients who progressed on front-line chemotherapy. Iovance anticipates presenting additional Cohort 3B data at a medical meeting in the second half of 2021.

Friedrich Graf Finckenstein, M.D., Chief Medical Officer of Iovance, stated, "There remains a very significant unmet need to increase response rates and prolong survival in the second line non-small cell lung cancer treatment setting. The initial data for LN-145 in this difficult to treat patient population is very promising."

The Cohort 3B data using Iovance’s TIL cell therapy are the first reported clinical data on TIL administered as a one-time monotherapy in mNSCLC from a prospective, multi-center study, and add significantly to the existing scientific data previously reported by Iovance’s collaborator H. Lee Moffitt Cancer Center.

Iovance also announced today that it dosed the first patient in IOV-LUN-202. Iovance previously opened the IOV-LUN-202 trial to investigate LN-145 in second-line mNSCLC where patients have progressed on one prior ICI and chemotherapy. This trial is designed to be supportive of registration.

Dr. Graf Finckenstein also stated: "We are excited to share our initial results for LN-145 in non-small cell lung cancer, a new potential indication for Iovance TIL cell therapy, which show positive outcomes in patients with high unmet medical need. We see a substantial opportunity to advance LN-145 in the post-ICI setting for patients with lung cancer. These data also have the potential to drive momentum with enrollment in our registration supporting study, IOV-LUN-202, as well as in two additional non-small cell lung cancer cohorts in IOV-COM-202, and we move ahead with great enthusiasm."

Carmot to receive royalty payments upon sales of Amgen’s FDA approved first-in-class KRAS G12C Inhibitor, LUMAKRAS™ (sotorasib); Further demonstrates the value of Carmot’s therapeutic platform

On June 29, 2021 Carmot Therapeutics, Inc. (Berkeley, CA), a clinical-stage biotechnology company applying its proprietary therapeutic platform, Chemotype Evolution (CE), to discover and develop disease-modifying therapies in metabolic disease and cancer, reported that in connection with the recent U.S. Food and Drug Administration (FDA) approval and commercial launch of Amgen’s LUMAKRAS (sotorasib), Carmot is eligible to receive royalty payments from future sales (Press release, Carmot, JUN 29, 2021, View Source [SID1234584452]).

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FDA recently approved LUMAKRAS for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy. LUMAKRAS has received accelerated approval based on overall response rate (ORR) and duration of response (DoR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Amgen and Carmot Therapeutics entered into a research collaboration and license agreement announced in 2014 with objectives that included identification of KRASG12C targeted therapeutics. Within this collaboration, Carmot and Amgen successfully applied Chemotype Evolution to identify novel binding sites and covalent inhibitors of KRASG12C. Amgen then built on those findings to develop LUMAKRAS. Under the terms of the agreement Carmot is entitled to research funding, milestone payments and a royalty on commercial sales of products emerging from the collaboration.

"The rapid development of LUMAKRAS illustrates the value of Chemotype Evolution and its ability to complement structure-based drug design and medicinal chemistry," commented Stig K. Hansen, PhD, Carmot’s co-founder and Chief Executive Officer. "Chemotype Evolution is a transformative technology that can accelerate the discovery of drugs for challenging targets. KRAS was deemed an undruggable target for decades, but Chemotype Evolution combined with published findings, enabled Carmot and Amgen to rapidly gain novel insights that aided Amgen in the discovery of AMG 510, now LUMAKRAS.

More broadly, we have greatly expanded the capabilities of Chemotype Evolution and used it to develop a portfolio of programs in metabolic disease and cancer. Just as Chemotype Evolution provided critical new insights into KRAS function, Carmot has used the technology to generate deep insights in other disease areas".

Boston Scientific Announces Conference Call Discussing Second Quarter 2021 Results

On June 29, 2021 Boston Scientific Corporation (NYSE: BSX) reported that it will webcast its conference call discussing financial results and business highlights for the second quarter ended June 30, 2021 on Tuesday, July 27, 2021 at 8:00 a.m. EDT (Press release, Boston Scientific, JUN 29, 2021, View Source [SID1234584451]). The call will be hosted by Mike Mahoney, chairman and chief executive officer, and Dan Brennan, executive vice president and chief financial officer. The company will issue a news release announcing financial results for the first quarter on July 27 prior to the conference call.

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A live webcast and replay of the webcast will be accessible at investors.bostonscientific.com. The replay will be available beginning approximately one hour following the completion of each event.

Vivoryon Therapeutics Provides Update on Financial Guidance

On June 29, 2021 Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) (Vivoryon), a clinical-stage biotechnology company focused on developing innovative small molecule-based medicines, reported an update on its financial guidance (Press release, Vivoryon Therapeutics, JUN 29, 2021, View Source [SID1234584443]). According to current estimates, the Company expects the recently signed regional licensing agreement with Simcere Pharmaceutical Group Ltd. to have an impact on Vivoryon’s previously communicated cash-reach of Q3 2022, which is anticipated to be extended for at least three quarters until Q2 2023. A detailed update on anticipated working capital requirements and resulting timelines will be given in the context of the Company’s regular filings.

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Vivoryon and Simcere have entered into a strategic regional licensing partnership to develop and commercialize medicines targeting the neurotoxic amyloid species N3pE (pGlu-Abeta) to treat Alzheimer’s disease (AD) in Greater China. Under the terms of the agreement, Vivoryon will receive an undisclosed upfront payment and will also be eligible for payments upon achievement of certain development and sales milestones, with all components amounting to a total of over US$565 M. In addition, Vivoryon will receive double-digit royalties on sales. Further financial details were not disclosed.