Inbakicept

Q1 2024 revenue of $54.6 million 9% year-over-year increase in Commercial Cell & Gene Therapy revenue 9% year-over-year increase in BioStorage/BioServices revenue A total of 675 global clinical trials supported as of March 31, 2024 $242 - $252 million full year 2024 revenue guidance reiterated NASHVILLE, Tenn., May 7, 2024 /PRNewswire/ -- Cryoport, Inc. (NASDAQ: CYRX) (Cryoport), a global leader in supply chain solutions for the life sciences, today announced financial results for the three months ended March 31 (Q1), 2024. Jerrell Shelton, CEO of Cryoport, commented, "For the first quarter, we continued to experience a difficult environment globally. Our quarterly results were disappointing, particularly for our Life Sciences Products. However, as stated when we initially provided our annual guidance, we anticipate our revenue will progressively improve throughout the year and we maintain our full year revenue guidance of $242 to $252 million. Continue Reading Growing Cell & Gene Therapy Pipeline "Our Life Sciences Services revenue growth for the first quarter was softer than anticipated, increasing 3% year-over-year. We believe there is a bright spot however, as the Cell & Gene Therapy market seems to be gaining some momentum again: three (3) new therapies have been approved this year to date; three (3) existing commercial therapies were approved to move to an earlier line of treatment; and two (2) therapies were approved to expand their label or geographic territory. With the expected revenue ramps of existing and new commercial therapies, we should see revenue acceleration from our Cell & Gene Therapy clients over the remainder of the year. Our outlook regarding regulatory approvals for the rest of the year is positive as we believe there are potentially five (5) new therapy approvals and three (3) additional label or geographic expansions for other currently approved therapies. "First quarter Life Sciences Products revenue was lower than in prior years, largely due to decreased demand for MVE Biological Solutions' (MVE) cryogenic systems. This was attributable to a continued slowdown in capital equipment investment that began last year. Although global in nature, the most severe pullback in demand continues to be in China. While we expect MVE's cryogenic system sales to be challenged throughout the remainder of the year as biotech funding, government budgets, and academic budgets are constrained, we want to remind investors that even in this difficult climate, MVE continues to produce positive cash flow for our company. MVE is the leading manufacturer of cryogenic systems worldwide and we are confident in the long-term prospects of our Life Sciences Products business. When demand normalizes, as we anticipate it will, we believe that we will benefit from our position as the global leader in this space. "Based on our clients' forecasts and fueled by the aforementioned industry indicators for Cell & Gene Therapies, we continue to invest to expand our support of these life-saving treatments at scale. However, in light of the current macroeconomic challenges and the impact on our financial results, we are implementing a number of initiatives to drive toward positive adjusted EBITDA and cash flow in the near term. These include improved alignment of our global organization, reduction in our work force, leveraging lower cost shared services centers, refining and reprioritizing planned initiatives, and delays in capital spending as a result of reprioritization, all of which we expect should positively impact our results of operations for the second half of 2024," concluded Mr. Shelton. In tabular form, Q1 2024 revenue compared to Q1 2023 was as follows: Revenue from the support of commercial Cell & Gene Therapies increased 9% year-over-year with two new therapies receiving approval during Q1 2024, bringing our current total commercial count to fourteen (14) as of March 31, 2024. Subsequent to quarter-end, in April the United States Food and Drug Administration (FDA) approved ImmunityBio's Anktiva for BCG-unresponsive non-muscle invasive bladder cancer, which is a Cryoport-supported therapy. This brings our number of commercial therapies supported to fifteen (15) as of May 7, 2024. As of March 31, 2024, Cryoport supported a total of 675 global clinical trials, a net increase of 23 clinical trials over March 31, 2023 with 77 of these clinical trials in Phase 3 . The number of trials by phase and region are as follows: During the remainder of 2024, we anticipate up to an additional sixteen (16) application filings, and as stated earlier, five (5) new therapy approvals and an additional three (3) label/geographic expansions. Financial Highlights Revenue Total revenue for Q1 2024 was $54.6 million compared to $62.8 million for Q1 2023, a year-over-year decrease of 13% or $8.2 million. Life Sciences Services revenue for Q1 2024 was $36.8 million, up 3% year-over-year, including BioStorage/BioServices revenue of $3.5 million, up 9% year-over-year. Life Sciences Products revenue for Q1 2024 was $17.8 million, down 34% year-over-year. Gross Margin Total gross margin was 39.9% for Q1 2024 compared to 43.1% for Q1 2023. Gross margin for Life Sciences Services was 41.3% for Q1 2024 compared to 46.8% for Q1 2023. Gross margin for Life Sciences Products was 37.0% for Q1 2024 compared to 38.2% for Q1 2023. Operating Costs and Expenses Operating costs and expenses were $43.1 million for Q1 2024 compared to operating costs and expenses of $37.1 million for Q1 2023. The increase is primarily attributable to personnel and other expenses related to our recent acquisitions and investment in growth initiatives, including our Integricell™ cryo-processing platform and BioServices offerings. Net Loss Net loss for Q1 2024 was $18.9 million compared to a net loss of $5.6 million for Q1 2023. Net loss attributable to common stockholders was $20.9 million, or $0.43 per share for Q1 2024. This compares to a net loss attributable to common stockholders of $7.6 million, or $0.16 per share for Q1 2023. Adjusted EBITDA Adjusted EBITDA was a negative $7.7 million for Q1 2024, compared to $2.9 million for Q1 2023. Cash, Cash equivalents, and Short-Term Investments Cryoport held $448.5 million in cash, cash equivalents, and short-term investments as of March 31, 2024. Note: All reconciliations of GAAP to adjusted (non-GAAP) figures above are detailed in the reconciliation tables included later in the press release. Outlook The Company is reiterating its full year 2024 revenue guidance of $242 - $252 million and continues to expect revenue to improve progressively throughout the year. The Company's 2024 guidance is dependent on its current business and expectations, which may be further impacted by, among other things, factors that are outside of our control, such as the global macroeconomic and geopolitical environment, supply chain constraints, inflationary pressures, and the effects of foreign currency fluctuations, as well as the other factors described in the Company's filings with the Securities and Exchange Commission ("SEC"), including in the "Risk Factors" section of its most recently filed periodic reports on Form 10-K and Form 10-Q, as well as in its subsequent filings with the SEC. Additional Information Further information on Cryoport's financial results is included in the attached condensed consolidated balance sheets and statements of operations, and additional explanations of Cryoport's financial performance are provided in the Company's Quarterly Report on Form 10-Q for the three months ended March 31, 2024, which is expected to be filed with the SEC on May 7, 2024. Additionally, the full report will be available in the SEC Filings section of the Investor Relations section of Cryoport's website at . Earnings Conference Call Information IMPORTANT INFORMATION: In addition to the earnings release, a document titled "Cryoport First Quarter 2024 in Review", providing a review of Cryoport's financial and operational performance and a general business update, will be issued at 4:05 p.m. ET on Tuesday, May 7, 2024. The document is designed to be read in advance of the questions and answers conference call and will be accessible at . Cryoport management will host a conference call at 5:00 p.m. ET on May 7, 2024. The conference call will be in the format of a questions and answers session and will address any queries investors have regarding the Company's reported results. A slide deck will accompany the call. Conference Call Information The questions and answers call will be recorded and available approximately three hours after completion of the live event in the Investor Relations section of the Company's website at for a limited time. To access the replay of the questions and answers click here. A dial-in replay of the call will also be available to those interested, until May 14, 2024. To access the replay, dial 1-844-512-2921 (United States) or 1-412-317-6671 (International) and enter replay entry code: 15315763#. About Cryoport, Inc. Cryoport, Inc. (Nasdaq: CYRX), is a global leader in supply chain solutions for cell & gene therapies that enable manufacturers, contract manufacturers (CDMO's), contract research organizations (CRO's), developers, and researchers to carry out their respective business with certainty. We provide a broad array of supply chain solutions for the life sciences industry. Through our platform of critical products and solutions including advanced temperature-controlled packaging, informatics, specialized bio-logistics services, bio-storage, bio-services, and cryogenic systems, we are "Enabling the Future of MedicineTM" worldwide, through our innovative systems, compliant procedures, and agile approach to superior supply chain management. Our corporate headquarters, located in Nashville, Tennessee, is complimented by over 50 global locations in 17 countries, with key sites in the United States, United Kingdom, France, the Netherlands, Portugal, Germany, Japan, Australia, India, and China. For more information, visit or follow via LinkedIn at or @cryoport on X, formerly known as Twitter at for live updates. Forward-Looking Statements Statements in this press release which are not purely historical, including statements regarding the Company's intentions, hopes, beliefs, expectations, representations, projections, plans or predictions of the future, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, those related to the Company's industry, business, long-term growth prospects, plans, strategies, acquisitions, future financial results and financial condition, such as the Company's outlook and guidance for full year 2024 revenue and the related assumptions and factors expected to drive revenue, projected growth trends in the markets in which the Company operates, the Company's plans and expectations regarding the launch of new products and services, such as the expected timing and benefits of such products and services launches, the Company's expectations about future benefits of its acquisitions, and anticipated regulatory filings, approvals, label/geographic expansions or moves to earlier lines of treatment approved with respect to the products of the Company's clients. Forward-looking statements also include those related to the Company's anticipation that its revenue will progressively improve throughout the year, including anticipated acceleration of revenue from the Company's Cell & Gene Therapy clients, the Company's expectations that MVE's cryogenic system sales will be challenged throughout the remainder of the year, the Company's expectations of the long-term prospects of its Life Sciences Products business, including the anticipation of demand normalizing, which would allow the Company to benefit from its position as the global leader in this space, and the Company's planned initiatives to drive toward positive adjusted EBITDA and cash flow in the near term, which it expects should positively impact its results of operations for the second half of 2024. It is important to note that the Company's actual results could differ materially from those in any such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, risks and uncertainties associated with the effect of changing economic and geopolitical conditions, supply chain constraints, inflationary pressures, the effects of foreign currency fluctuations, trends in the products markets, variations in the Company's cash flow, market acceptance risks, and technical development risks. The Company's business could be affected by other factors discussed in the Company's SEC reports, including in the "Risk Factors" section of its most recently filed periodic reports on Form 10-K and Form 10-Q, as well as in its subsequent filings with the SEC. The forward-looking statements contained in this press release speak only as of the date hereof and the Company cautions investors not to place undue reliance on these forward-looking statements. Except as required by law, the Company disclaims any obligation, and does not undertake to update or revise any forward-looking statements in this press release. Note Regarding Use of Non-GAAP Financial Measures To supplement our financial statements, which are presented on the basis of U.S. generally accepted accounting principles (GAAP), the following non-GAAP measures of financial performance as defined in Regulation G of the Securities Exchange Act of 1934 are included in this release: revenue at constant currency, revenue growth rate at constant currency and adjusted EBITDA. Non-GAAP financial measures are not calculated in accordance with GAAP, are not based on any comprehensive set of accounting rules or principles and may be different from non-GAAP financial measures presented by other companies. Non-GAAP financial measures, including revenue at constant currency, revenue growth rate at constant currency and adjusted EBITDA, should not be considered as a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP. We believe that revenue growth is a key indicator of how Cryoport is progressing from period to period and we believe that the non-GAAP financial measures, revenue at constant currency and revenue growth rate at constant currency, are useful to investors in analyzing the underlying trends in revenue. Under GAAP, revenue received in local (non-U.S. dollar) currency is translated into U.S. dollars at the average exchange rate for the period presented. As a result, fluctuations in foreign currency exchange rates affect the results of our operations and the value of our foreign assets and liabilities, which in turn may adversely affect results of operations and cash flows and the comparability of period-to-period results of operations. When we use the term "constant currency," it means that we have translated local currency revenue for the current reporting period into U.S. dollars using the same average foreign currency exchange rates for the conversion of revenue into U.S. dollars that we used to translate local currency revenue for the comparable reporting period of the prior year. Revenue growth rate at constant currency refers to the measure of comparing the current reporting period revenue at constant currency with the reported GAAP revenue for the comparable reporting period of the prior year. However, we also believe that data on constant currency period-over-period changes have limitations, particularly as the currency effects that are eliminated could constitute a significant element of our revenue and could significantly impact our performance. We therefore limit our use of constant currency period-over-period changes to a measure for the impact of currency fluctuations on the translation of local currency revenue into U.S. dollars. We do not evaluate our results and performance without considering both period-over-period changes in non-GAAP constant currency revenue on the one hand and changes in revenue prepared in accordance with GAAP on the other. We caution the readers of this press release to follow a similar approach by considering revenue on constant currency period-over-period changes only in addition to, and not as a substitute for, or superior to, changes in revenue prepared in accordance with GAAP. Adjusted EBITDA is defined as net loss adjusted for interest expense, income taxes, depreciation and amortization expense, stock-based compensation expense, acquisition and integration costs, investment income, unrealized (gain)/loss on investments, foreign currency (gain)/loss, gain on insurance claim, changes in fair value of contingent consideration and charges or gains resulting from non-recurring events. Management believes that adjusted EBITDA provides a useful measure of Cryoport's operating results, a meaningful comparison with historical results and with the results of other companies, and insight into Cryoport's ongoing operating performance. Further, management and the Company's board of directors utilize adjusted EBITDA to gain a better understanding of Cryoport's comparative operating performance from period to period and as a basis for planning and forecasting future periods. Adjusted EBITDA is also a significant performance measure used by Cryoport in connection with its incentive compensation programs. Management believes adjusted EBITDA, when read in conjunction with Cryoport's GAAP financials, is useful to investors because it provides a basis for meaningful period-to-period comparisons of Cryoport's ongoing operating results, including results of operations, against investor and analyst financial models, helps identify trends in Cryoport's underlying business and in performing related trend analyses, and it provides a better understanding of how management plans and measures Cryoport's underlying business. SOURCE Cryoport, Inc.

ANKTIVA® Drug Substance completed and released with two-year storage stability data sufficient for 170,000 doses of ANKTIVA product ImmunityBio’s 400,000 square foot GMP fill-finish facility in Dunkirk, New York on track to be completed in 12-18 months with capacity to produce a million vials annually Coupled with a recent announcement of BCG availability in partnership with the Serum Institute of India (SII), ImmunityBio has large-scale inventory and capacity for BCG CULVER CITY, Calif.--(BUSINESS WIRE)-- ImmunityBio, Inc. (NASDAQ: IBRX) announced today that the drug substance (DS) has been completed and successfully qualified for “fill finish” (filling vials and finishing packaging), sufficient for 170,000 doses of 400mcg ANKTIVA (nogapendekin alfa inbakicept-pmln). Coupled with the recent announcement of a partnership with the Serum Institute of India (SII) for BCG availability, this provides the Company with a significant initial supply of ANKTIVA for commercial and clinical trial use in advance of the full operation of the Company’s own drug substance and fill-finish manufacturing plants in California and New York. This press release features multimedia. View the full release here: ImmunityBio’s state-of-the-art GMP biological manufacturing facility in Dunkirk, New York (Photo: Business Wire) Since the Company’s merger with NantKwest in 2021, ImmunityBio has made significant capital investments in personnel, plants, and equipment to ensure global capacity of ANKTIVA drug product for both the commercial launch, as well as clinical trials in bladder cancer and other tumor types in its pipeline. Both drug substance (DS) and drug product (DP) facilities are nearing completion to ensure sufficient capacity and multiple GMP manufacturing sites for ANKTIVA in its approved indication, as well as for clinical trials and future indications. “When we began the development of ANKTIVA and enlisted our contract manufacturer, we believed that the manufacture of a biologic as complicated as ANKTIVA was best served by having multiple sites of manufacturing, including in-house capacity and external partners,” said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio. “Our investment since 2021 in our facilities, together with the agreement entered into with the Serum Institute of India (SII) ensures that both ANKTIVA and BCG could be available at scale on a global basis.” In 2020, the company began construction of a state-of-the-art biological manufacturing plant in California with large-scale bioreactors for ANKTIVA drug substance and it is anticipated to be completed in the next 12-18 months. The large-scale equipment needed for GMP biological manufacture, with long-lead times, are on site and will be installed in the next 12 months. Upon completion, this 100,000 square foot manufacturing site will have the capacity to manufacture drug substance sufficient for a million doses of ANKTIVA a year. The drug product will be filled at the Dunkirk, New York facility, a 400,000 square foot state-of-the-art GMP facility in which the fill-finish equipment has been purchased and is in the process of being installed. These infrastructure capacity plans were initiated in anticipation of the approval of ANKTIVA in combination with BCG for non-muscle invasive bladder cancer, carcinoma in situ (CIS), to ensure that ImmunityBio has sufficient drug product supply, not only for the first commercial launch of ANKTIVA but for other clinical trials and indications. “Our belief in the importance of this molecule and its potential to evolve immunotherapy to the next level, guided our strategic plan to invest for the future with anticipation of ANKTIVA’s approval,” said Rich Adcock, CEO & President ImmunityBio. “I’m grateful for our employees and our investors who have supported and believed in our commitment to invest for our long-term vision and future.” About ImmunityBio ImmunityBio is a vertically-integrated biotechnology company developing next-generation therapies and vaccines that bolster the natural immune system to defeat cancers and infectious diseases. The company’s range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA® is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer that activates natural killer cells, T cells, and memory T cells for a long duration response. The company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases. For more information, please visit: Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements regarding the scale of production capacity for the manufacturing facilities referenced herein, the anticipated uses of such facilities, anticipated timelines for completion of such facilities and operational status of such facilities, the collaboration between ImmunityBio and the Serum Institute of India and expected results therefrom, clinical trials and potential implications therefrom, commercialization plans and timelines, the regulatory review process and timing thereof, potential future uses and applications of ANKTIVA in additional indications, and ImmunityBio’s approved product and investigational agents as compared to existing treatment options, among others. Statements in this press release that are not statements of historical fact are considered forward-looking statements, which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “goal,” “could,” “estimates,” “scheduled,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “indicate,” “projects,” “seeks,” “should,” “will,” “strategy,” and variations of such words or similar expressions. Statements of past performance, efforts, or results of our preclinical and clinical trials, about which inferences or assumptions may be made, can also be forward-looking statements and are not indicative of future performance or results. Forward-looking statements are neither forecasts, promises nor guarantees, and are based on the current beliefs of ImmunityBio’s management as well as assumptions made by and information currently available to ImmunityBio. Such information may be limited or incomplete, and ImmunityBio’s statements should not be read to indicate that it has conducted a thorough inquiry into, or review of, all potentially available relevant information. Such statements reflect the current views of ImmunityBio with respect to future events and are subject to known and unknown risks, including business, regulatory, economic and competitive risks, uncertainties, contingencies and assumptions about ImmunityBio, including, without limitation, (i) potential delays in product availability and regulatory approvals, (ii) whether the BCG manufactured by Serum will receive regulatory approval in the U.S. and/or other regions, (iii) the risks and uncertainties associated with commercial launch execution, success and timing, (v) additional risks and uncertainties related to the regulatory submission and review process, (vi) the ability of ImmunityBio to continue its planned preclinical and clinical development of its development programs through itself and/or its investigators, and the timing and success of any such continued preclinical and clinical development, patient enrollment and planned regulatory submissions, (vii) the ability of ImmunityBio and/or its contractors to complete the construction or address construction needs at ImmunityBio’s manufacturing facilities on the anticipated timelines, or at all, (viii) ImmunityBio’s ability to comply with the covenants and obligations under the Dunkirk facility lease agreement and related agreements and potential implications thereof, (ix) the risks and uncertainties associated with third party collaborations and agreements, (x) ImmunityBio’s ability to obtain additional financing to fund its operations and complete the development and commercialization of its various product candidates, (xi) potential product shortages or manufacturing disruptions that may impact the availability and timing of product, (xii) ImmunityBio’s ability to scale its manufacturing and commercial supply operations for its product candidates and future approved products, and (xiii) ImmunityBio’s ability to obtain, maintain, protect and enforce patent protection and other proprietary rights for its product candidates and technologies. More details about these and other risks that may impact ImmunityBio’s business are described under the heading “Risk Factors” in the Company’s Form 10-K filed with the U.S. Securities and Exchange Commission (“SEC”) on March 19, 2024 and in subsequent filings made by ImmunityBio with the SEC, which are available on the SEC’s website at . ImmunityBio cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof. ImmunityBio does not undertake any duty to update any forward-looking statement or other information in this press release, except to the extent required by law. View source version on businesswire.com: Contacts Investors Hemanth Ramaprakash, PhD, MBA ImmunityBio, Inc. +1 858-746-9289 Hemanth.Ramaprakash@ImmunityBio.com Media Greg Tenor Salutem +1 717-919-6794 Gregory.Tenor@Salutemcomms.com Source: ImmunityBio, Inc. Smart Multimedia Gallery Photo ImmunityBio’s state-of-the-art GMP biological manufacturing facility in Dunkirk, New York (Photo: Business Wire) Logo View this news release and multimedia online at: