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Technology

Catalent, Inc. reports second quarter fiscal 2021 results

  • Q2’21 net revenue of $910.8 million increased 26% as-reported, or 24% in constant currency, compared to Q2’20. Organic, constant currency net revenue grew 17%, compared to Q2’20.
  • Q2’21 net earnings of $88.4 million increased 94%, or 88% in constant currency, compared to Q2’20.
  • Q2’21 Adjusted EBITDA of $223.5 million increased 31% as-reported, or 28% in constant currency, compared to Q2’20.
  • Q2’21 Biologics segment net revenue of $403.9 million increased more than 75%, compared to Q2’20.
  • Increasing guidance to reflect projected net revenue growth of 23-28% and Adjusted EBITDA growth of 26-33%, compared to projected net revenue growth in previous guidance of 16-22% and Adjusted EBITDA growth of 17-26%.

SOMERSET, N.J. — (BUSINESS WIRE) — Catalent, Inc. (NYSE: CTLT), the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, today announced financial results for the second quarter of fiscal 2021, which ended December 31, 2020.

“Our second quarter results reflect robust organic growth in our Biologics segment, and our increased guidance reflects our expectation of continued strong results for these offerings for the remainder of our fiscal year. Additional capacity in our drug product and drug substance offerings will come on line in the second half of our fiscal year to help fight the pandemic and serve other critical patient needs,” said John Chiminski, Chair and Chief Executive Officer of Catalent, Inc.

Second Quarter 2021 Consolidated Results

Net revenue of $910.8 million increased 26% as reported, or 24% in constant currency, from the $721.4 million reported for the second quarter a year ago. Overall organic revenue growth (i.e., excluding the effect of acquisitions) was 17%.

Net earnings were $88.4 million. Accounting for the net earnings attributable to holders of Catalent’s Series A convertible preferred stock, net earnings attributable to common shareholders were $76.6 million, or $0.46 per basic share, compared to net earnings attributable to common shareholders of $34.3 million, or $0.23 per basic share, in the second quarter a year ago.

EBITDA from operations, as referenced in the GAAP to non-GAAP reconciliation provided later in this release, was $205.9 million, an increase of $50.6 million from $155.3 million in the second quarter a year ago. Second quarter fiscal 2021 Adjusted EBITDA (see the GAAP to non-GAAP reconciliation provided later in this release) was $223.5 million, or 24.5% of net revenue, compared to $171.0 million, or 23.7% of net revenue, in the second quarter a year ago. This represents an increase of 30.7% as reported, and an increase of 27.8% on a constant-currency basis.

Adjusted Net Income (see the GAAP to non-GAAP reconciliation) was $114.4 million, or $0.63 per diluted share, compared to Adjusted Net Income of $72.0 million, or $0.45 per diluted share, in the second quarter a year ago.

Second Quarter 2021 Segment Review

Biologics

Net revenue from the Biologics segment was $403.9 million for the second quarter of fiscal 2021, an increase of 79% as reported and 76% in constant currency, compared to the second quarter a year ago. Segment EBITDA (see the GAAP to non-GAAP reconciliation provided later in this release) in the second quarter of fiscal 2021 was $135.5 million, an increase of 115% as reported and 109% in constant currency compared to the second quarter a year ago. Segment EBITDA margin was 33.5% in the second quarter of fiscal 2021 compared to 28.0% in the second quarter of the prior year.

Excluding the effect of acquisitions, net revenue increased 65% and segment EBITDA increased 104% compared to the three months ended December 31, 2019.

The Biologics segment represented 44% of Catalent’s total net revenue in the second quarter of fiscal 2021.

Softgel and Oral Technologies

Net revenue from the Softgel and Oral Technologies segment was $246.6 million for the second quarter of fiscal 2021, a decrease of 8% as reported or 10% in constant currency, compared to the second quarter a year ago. Segment EBITDA was $45.6 million in the second quarter of fiscal 2021, a decrease of 29% as reported, or 31% in constant currency, compared to the second quarter a year ago. Segment EBITDA margin was 18.5% in the second quarter of fiscal 2021 compared to 24.1% in the second quarter of the prior year.

The Softgel and Oral Technologies segment represented 27% of Catalent’s total net revenue in the second quarter of fiscal 2021.

Oral and Specialty Delivery

Net revenue from the Oral and Specialty Delivery segment was $169.9 million for the second quarter of fiscal 2021, an increase of 19% as reported and 17% in constant currency, over the second quarter a year ago. Segment EBITDA in the second quarter of fiscal 2021 was $44.2 million, an increase of 34% as reported, or 31% in constant currency, compared to the second quarter a year ago. Segment EBITDA margin was 26.0% in the second quarter of fiscal 2021 compared to 23.1% in the second quarter of the prior year.

Excluding the effect of acquisitions, net revenue increased 2% and segment EBITDA increased 9% compared to the three months ended December 31, 2019.

The Oral and Specialty Delivery segment represented 19% of Catalent’s total net revenue in the second quarter of fiscal 2021.

Clinical Supply Services

Net revenue from the Clinical Supply Services segment was $93.5 million for the second quarter of fiscal 2021, an increase of 6% as reported and 4% in constant currency, compared to the second quarter a year ago. Segment EBITDA in the second quarter of fiscal 2021 was $25.3 million, an increase of 5% as reported, or 2% in constant currency, compared to the second quarter a year ago. Segment EBITDA margin was 27.1% in the second quarter of fiscal 2021 compared to 27.3% in the second quarter of the prior year.

The Clinical Supply Services segment represented 10% of Catalent’s total net revenue in the second quarter of fiscal 2021.

Balance Sheet and Liquidity

As of December 31, 2020, Catalent had $3.1 billion in total debt, and $2.2 billion in total debt net of cash and short-term investments, compared to $2.1 billion in total net debt as of September 30, 2020. The current debt structure does not include any significant maturity until 2026.

Catalent’s net leverage ratio (see the GAAP to non-GAAP reconciliation provided later in this release) as of December 31, 2020 was 2.6x, compared to 2.6x at September 30, 2020 and 4.2x at December 31, 2019.

Fiscal Year 2021 Outlook

Catalent is raising its previously issued guidance to reflect second quarter performance and to account for higher net underlying demand, including increased demand related to COVID-19 treatments and vaccines, partially offset by lower demand in some offerings attributable to the effects of the pandemic.

The revised guidance assumes no major unforeseen change to either the current status of the COVID-19 pandemic generally or its effect on Catalent’s operations and business. The revised guidance does not assume the receipt of any vaccine or treatment order from any of our customers beyond what either has been received to date or is deemed required under executed take-or-pay arrangements. The revised guidance ranges are wider than the ranges we have forecasted in the previous few fiscal years due to the continuing uncertainty in both revenues and costs across our businesses engendered by the COVID-19 pandemic. The revised guidance projects:

  • Net revenue for fiscal 2021 in the range of $3.80 billion to $3.95 billion, compared to the previous range of $3.58 billion to $3.78 billion;
  • Adjusted EBITDA for fiscal 2021 in the range of $950 million to $1,000 million, compared to the previous range of $880 million to $950 million;
  • Adjusted Net Income for fiscal 2021 in the range of $475 million to $525 million, compared to the previous range of $410 million to $470 million; and
  • A fully diluted share count in the range of 180 million to 182 million shares on a weighted-average basis, which includes the outstanding Series A Convertible Preferred Stock as-if converted, compared to the previous range of 178 million to 180 million shares.

Earnings Webcast

The Company’s management will host a webcast to discuss the results at 8:15 a.m. ET today. Catalent invites all interested parties to listen to the webcast, which will be accessible through Catalent’s website at http://investor.catalent.com. A supplemental slide presentation will also be available in the “Investors” section of Catalent’s website prior to the start of the webcast. The webcast replay, along with the supplemental slides, will be available for 90 days in the “Investors” section of Catalent’s website at www.catalent.com.

About Catalent, Inc.

Catalent, Inc. (NYSE: CTLT), an S&P 500® company, is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs more than 14,000 people, including approximately 2,500 scientists, at more than 45 facilities across four continents and in fiscal year 2020 generated over $3 billion in annual revenue. Catalent is headquartered in Somerset, N.J. For more information, please visit www.catalent.com.

Non-GAAP Financial Measures

Use of EBITDA from operations, Adjusted EBITDA, Adjusted Net Income and Segment EBITDA

Management measures operating performance based on consolidated earnings from operations before interest expense, expense (benefit) for income taxes, and depreciation and amortization, adjusted for the income or loss attributable to non-controlling interests (“EBITDA from operations”). EBITDA from operations is not defined under U.S. GAAP, is not a measure of operating income, operating performance, or liquidity presented in accordance with U.S. GAAP, and is subject to important limitations.

Catalent believes that the presentation of EBITDA from operations enhances an investor’s understanding of its financial performance. Catalent believes this measure is a useful financial metric to assess its operating performance across periods by excluding certain items that it believes are not representative of its core business and uses this measure for business planning purposes.

In addition, given the significant investments that Catalent has made in the past in property, plant and equipment, depreciation and amortization expenses represent a meaningful portion of its cost structure. Catalent believes that EBITDA from operations will provide investors with a useful tool for assessing the comparability between periods of its ability to generate cash from operations sufficient to pay taxes, to service debt and to undertake capital expenditures because it eliminates depreciation and amortization expense. Catalent presents EBITDA from operations in order to provide supplemental information that it considers relevant for the readers of its consolidated financial statements, and such information is not meant to replace or supersede U.S. GAAP measures. Catalent’s definition of EBITDA from operations may not be the same as similarly titled measures used by other companies.

Catalent evaluates the performance of its segments based on segment earnings before non-controlling interest, other (income) expense, impairments, restructuring costs, interest expense, income tax expense (benefit), and depreciation and amortization (“segment EBITDA”). Moreover, under Catalent’s credit agreement, its ability to engage in certain activities, such as incurring certain additional indebtedness, making certain investments and paying certain dividends, is tied to ratios based on Adjusted EBITDA, which is not defined under U.S. GAAP, is not a measure of operating income, operating performance, or liquidity presented in accordance with U.S. GAAP, and is subject to important limitations. Adjusted EBITDA is the covenant compliance measure used in the credit agreement governing debt incurrence and restricted payments. Because not all companies use identical calculations, Catalent’s presentation of Adjusted EBITDA may not be comparable to other similarly titled measures of other companies.

Management also measures operating performance based on Adjusted Net Income (Loss) and Adjusted Net Income (Loss) per share. Adjusted Net Income (Loss) is not defined under U.S. GAAP, is not a measure of operating income, operating performance, or liquidity presented in accordance with U.S. GAAP and is subject to important limitations. Catalent believes that the presentation of Adjusted Net Income (Loss) and Adjusted Net Income (Loss) per share enhances an investor’s understanding of its financial performance. Catalent believes these measures are a useful financial metric to assess its operating performance across periods by excluding certain items that it believes are not representative of its core business and Catalent uses these measures for business planning purposes. Catalent defines Adjusted Net Income (Loss) as net earnings (loss) adjusted for amortization attributable to purchase accounting and adjustments for other cash and non-cash items included in the table below, partially offset by its estimate of the tax effects of such cash and non-cash items. Catalent believes that Adjusted Net Income (Loss) and Adjusted Net Income (Loss) per share provides investors with a useful tool for assessing the comparability between periods of its ability to generate cash from operations available to its stockholders. Catalent’s definition of Adjusted Net Income (Loss) may not be the same as similarly titled measures used by other companies.

The most directly comparable U.S. GAAP measure to EBITDA from operations, Adjusted EBITDA and Adjusted Net Income (Loss) is net earnings (loss). Included in this release is a reconciliation of net earnings (loss) to EBITDA from operations, Adjusted EBITDA and Adjusted Net Income.

Catalent does not provide a reconciliation of forward-looking non-GAAP financial measures to their comparable U.S. GAAP financial measures because it could not do so without unreasonable effort due to the unavailability of the information needed to calculate reconciling items and due to the variability, complexity and limited visibility of the adjusting items that would be excluded from the non-GAAP financial measures in future periods. When planning, forecasting, and analyzing future periods, Catalent does so primarily on a non-GAAP basis without preparing a U.S. GAAP analysis as that would require estimates for various cash and non-cash reconciling items that would be difficult to predict with reasonable accuracy. For example, equity compensation expense would be difficult to estimate because it depends on Catalent’s future hiring and retention needs, as well as the future fair market value of its common stock, all of which are difficult to predict and subject to constant change. It is equally difficult to anticipate the need for or magnitude of a presently unforeseen one-time restructuring expense or the values of end-of-period foreign currency exchange rates. As a result, Catalent does not believe that a U.S. GAAP reconciliation would provide meaningful supplemental information about its outlook.

Use of Constant Currency

As changes in exchange rates are an important factor in understanding period-to-period comparisons, Catalent believes the presentation of results on a constant-currency basis in addition to reported results helps improve investors’ ability to understand its operating results and evaluate its performance in comparison to prior periods. Constant-currency information compares results between periods as if exchange rates had remained constant period over period. Catalent uses results on a constant-currency basis as one measure to evaluate its performance. Catalent calculates constant currency by calculating current-year results using prior-year foreign currency exchange rates. Catalent generally refers to such amounts calculated on a constant-currency basis as excluding the impact of foreign exchange or being on a constant-currency basis. These results should be considered in addition to, not as a substitute for, results reported in accordance with U.S. GAAP. Results on a constant-currency basis, as Catalent presents them, may not be comparable to similarly titled measures used by other companies and are not measures of performance presented in accordance with U.S. GAAP.

Forward-Looking Statements

This release contains both historical and forward-looking statements. All statements other than statements of historical fact, are, or may be deemed to be, forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements generally can be identified by the use of statements that include phrases such as “believe,” “expect,” “anticipate,” “intend,” “estimate,” “plan,” “project,” “foresee,” “likely,” “may,” “will,” “would,” or other words or phrases with similar meanings. Similarly, statements that describe Catalent’s objectives, plans, or goals are, or may be, forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Catalent’s expectations and projections. Some of the factors that could cause actual results to differ include, but are not limited to, the following: the current or future effects of the COVID-19 pandemic on Catalent’s and its clients’ businesses; participation in a highly competitive market and increased competition that may adversely affect Catalent’s business; demand for its offerings, which depends in part on its customers’ research and development and the clinical and market success of their products; product and other liability risks that could adversely affect Catalent’s results of operations, financial condition, liquidity and cash flows; failure to comply with existing and future regulatory requirements; failure to provide quality offerings to customers could have an adverse effect on Catalent’s business and subject it to regulatory actions and costly litigation; problems providing the highly exacting and complex services or support required; global economic, political and regulatory risks to Catalent’s operations; inability to enhance existing or introduce new technology or service offerings in a timely manner; inadequate patents, copyrights, trademarks and other forms of intellectual property protections; fluctuations in the costs, availability, and suitability of the components of the products Catalent manufactures, including active pharmaceutical ingredients, excipients, purchased components and raw materials; changes in market access or healthcare reimbursement in the United States or internationally; fluctuations in the exchange rate of the U.S. dollar against other currencies, including as a result of the U.K.’s exit from the European Union; adverse tax legislative or regulatory initiatives or challenges or adjustments to Catalent’s tax positions; loss of key personnel; risks generally associated with information systems; inability to complete any future acquisitions or other transactions that may complement or expand its business or divest of non-strategic businesses or assets and difficulties in successfully integrating acquired businesses and realizing anticipated benefits of such acquisitions; risks associated with timely and successfully completing, and correctly anticipating the future demand predicted for, capital expansion projects at existing facilities, offerings and customers’ products that may infringe on the intellectual property rights of third parties; environmental, health and safety laws and regulations, which could increase costs and restrict operations; labor and employment laws and regulations or labor difficulties, which could increase costs or result in operational disruptions; additional cash contributions required to fund Catalent’s existing pension plans; substantial leverage that may limit its ability to raise additional capital to fund operations and react to changes in the economy or in the industry; and exposure to interest-rate risk to the extent of its variable-rate debt preventing it from meeting its obligations under its indebtedness. For a more detailed discussion of these and other factors, see the information under the caption “Risk Factors” in Catalent’s Annual Report on Form 10-K for the fiscal year ended June 30, 2020, filed August 31, 2020. All forward-looking statements speak only as of the date of this release or as of the date they are made, and Catalent does not undertake to update any forward-looking statement as a result of new information or future events or developments except to the extent required by law.

More products. Better treatments. Reliably supplied.™

Catalent, Inc. and Subsidiaries

Consolidated Statements of Operations

(Unaudited; dollars and shares in millions, except per share data)

Three Months Ended
December 31,

FX Impact

Constant Currency

Increase/(Decrease)

2020

2019

Change $

Change %

Net revenue

$

910.8

$

721.4

$

17.9

$

171.5

24

%

Cost of sales

612.6

489.2

10.9

112.5

23

%

Gross margin

298.2

232.2

7.0

59.0

25

%

Selling, general, and administrative expenses

165.5

141.0

1.4

23.1

16

%

Impairment charges and (gain) loss on sale of assets

0.6

1.7

(1.1)

(65)

%

Restructuring and other

5.5

0.5

0.1

4.9

980

%

Operating earnings

126.6

89.0

5.5

32.1

36

%

Interest expense, net

25.9

34.9

0.2

(9.2)

(26)

%

Other (income) expense, net

(8.3)

(4.4)

1.8

(5.7)

130

%

Earnings before income taxes

109.0

58.5

3.5

47.0

80

%

Income tax expense

20.6

13.0

0.7

6.9

53

%

Net earnings

$

88.4

$

45.5

$

2.8

$

40.1

88

%

Less: Net earnings attributable to preferred shareholders

(11.8)

(11.2)

%

Net earnings attributable to common shareholders

$

76.6

$

34.3

$

$

%

Weighted average shares outstanding – basic

167.1

146.1

Weighted average diluted shares outstanding – diluted

169.3

147.7

Earnings per share:

Basic

Net earnings

$

0.46

$

0.23

Diluted

Net earnings

$

0.45

$

0.23

Catalent, Inc. and Subsidiaries

Selected Segment Financial Data

(Unaudited; dollars in millions)

Three Months Ended
December 31,

FX Impact

Constant Currency

Increase/(Decrease)

2020

2019

Change $

Change %

Biologics

Net revenue

$

403.9

$

225.2

$

7.9

$

170.8

76

%

Segment EBITDA

135.5

63.0

3.9

68.6

109

%

Softgel and Oral Technologies

Net revenue

246.6

267.9

5.2

(26.5)

(10)

%

Segment EBITDA

45.6

64.5

1.0

(19.9)

(31)

%

Oral and Specialty Delivery

Net revenue

169.9

143.2

2.7

24.0

17

%

Segment EBITDA

44.2

33.1

0.9

10.2

31

%

Clinical Supply Services

Net revenue

93.5

87.9

2.0

3.6

4

%

Segment EBITDA

25.3

24.0

0.9

0.4

2

%

Inter-segment revenue elimination

(3.1)

(2.8)

0.1

(0.4)

(14)

%

Unallocated costs

(44.7)

(29.3)

(2.1)

(13.3)

(45)

%

Combined totals

Net revenue

$

910.8

$

721.4

$

17.9

$

171.5

24

%

EBITDA from operations

$

205.9

$

155.3

$

4.6

$

46.0

30

%

Contacts

Investor Contact:

Catalent, Inc.

Paul Surdez

732-537-6325

investors@catalent.com

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Categories
Healthcare

Exelixis and Catalent enter into collaboration, license, and exclusive option agreement to develop antibody-drug conjugates leveraging SMARTag® bioconjugation technology

  • Companies will partner to develop novel antibody-drug conjugates using Catalent’s SMARTag bioconjugation platform and monoclonal antibodies from Exelixis’ growing preclinical pipeline
  • Agreement includes exclusive options on multiple targets over three-year term, with potential to extend time and scope of the collaboration
  • Deal is the fifth pipeline-enhancing agreement signed by Exelixis since 2018

ALAMEDA, Calif. & SOMERSET, N.J.–(BUSINESS WIRE)–Exelixis, Inc. (Nasdaq: EXEL) and Catalent today announced a partnership under which Catalent’s Redwood Bioscience subsidiary will develop multiple antibody-drug conjugates (ADCs) for Exelixis using Catalent’s proprietary SMARTag® site-specific bioconjugation technology.

Under the terms of the agreement, Catalent will use its SMARTag® bioconjugation platform to build ADCs using monoclonal antibodies (mAbs) from Exelixis’ growing preclinical pipeline. In exchange for an upfront payment to Catalent of $10 million, Exelixis received an exclusive option to nominate up to a fixed number of targets using the SMARTag® ADC platform over a three-year period. The companies plan to advance the ADCs into preclinical development, and, prior to filing an Investigational New Drug application, Exelixis may exercise its exclusive option to a worldwide license of the related ADC program and continue clinical development and commercialization. Exelixis will provide research & development funding, and Catalent will be eligible for development and commercial milestones and royalties on net sales of any product commercialized as part of the collaboration.

Developed by Catalent’s Redwood Bioscience subsidiary, the SMARTag® technology platform provides optimized site-specific protein-modification and linker technologies for ADCs and other bioconjugates. The SMARTag® platform overcomes the limitations associated with traditional protein chemistries that produce heterogeneous products with variable conjugate potency, toxicity, and stability and enables the development of ADCs with a wider therapeutic window and improved manufacturability.

“With our lead product CABOMETYX now a global oncology franchise, over the past several years Exelixis has moved beyond our small molecule medicinal chemistry roots to build out a pipeline that encompasses a variety of promising therapeutic modalities,” said Peter Lamb, Ph.D., Executive Vice President, Scientific Strategy and Chief Scientific Officer of Exelixis. “Our collaboration with Catalent – the fifth pipeline-enhancing agreement we’ve signed since 2018 – provides an attractive framework for identifying and advancing differentiated ADC product candidates with the potential to improve upon current ADC therapies. We are looking forward to working with Catalent as we rapidly advance our mission to help cancer patients recover stronger and live longer.”

The SMARTag® platform has recently demonstrated promising results in the clinic, highlighting the potential to create ADCs with significantly expanded therapeutic indices,” commented Mike Riley, Region President, Catalent Biologics, North America. “We are excited to partner with Exelixis, a leading oncology biotechnology company, and leverage our experienced team, unique SMARTag® technology platform, and deep analytical expertise to develop ADCs targeting various oncology indications.”

About Catalent Biologics

Catalent Biologics is a global leader in development, manufacturing and analytical services for new biological entities, cell and gene therapies, biosimilars, sterile injectables, and antibody-drug conjugates. With over 20 years of proven expertise, Catalent Biologics has worked with 600+ mAbs and 80+ proteins, produced 13 biopharmaceutical drugs using GPEx® cell line development technology, and manufactured 35+ commercially approved products. Catalent Cell & Gene Therapy, a unit of Catalent Biologics, is a full-service partner for adeno-associated virus (AAV) vectors and CAR-T immunotherapies, with deep experience in viral vector scale-up and production. Catalent recently acquired MaSTherCell, adding expertise in autologous and allogeneic cell therapy development and manufacturing. Catalent Cell & Gene Therapy has produced 100+ cGMP batches across 70+ clinical and commercial programs. For more information, visit biologics.catalent.com.

About Catalent

Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs over 13,900 people, including approximately 2,400 scientists and technicians, at more than 45 facilities, and in fiscal year 2020 generated over $3 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com

More products. Better treatments. Reliably supplied.™

About Exelixis

Founded in 1994, Exelixis, Inc. is a commercially successful, oncology-focused biotechnology company that strives to accelerate the discovery, development and commercialization of new medicines for difficult-to-treat cancers. Following early work in model system genetics, we established a broad drug discovery and development platform that has served as the foundation for our continued efforts to bring new cancer therapies to patients in need. Our discovery efforts have resulted in four commercially available products, CABOMETYX® (cabozantinib), COMETRIQ® (cabozantinib), COTELLIC® (cobimetinib) and MINNEBRO® (esaxerenone), and we have entered into partnerships with leading pharmaceutical companies to bring these important medicines to patients worldwide. Supported by revenues from our marketed products and collaborations, we are committed to prudently reinvesting in our business to maximize the potential of our pipeline. We are supplementing our existing therapeutic assets with targeted business development activities and internal drug discovery — all to deliver the next generation of Exelixis medicines and help patients recover stronger and live longer. Exelixis is a member of the Standard & Poor’s (S&P) MidCap 400 index, which measures the performance of profitable mid-sized companies. For more information about Exelixis, please visit www.exelixis.com, follow @ExelixisInc on Twitter or like Exelixis, Inc. on Facebook.

Exelixis Forward-Looking Statements

This press release contains forward-looking statements, including, without limitation, statements related to: Exelixis’ immediate and potential future financial and other obligations under the collaboration, option and exclusive license agreement with Catalent; the potential for the collaboration with Catalent to result in the advancement of differentiated ADC product candidates with the potential to improve upon current ADC therapies and advance Exelixis’ mission to help cancer patients recover stronger and live longer; and Exelixis’ plans to reinvest in its business to maximize the potential of the company’s pipeline, including through targeted business development activities and internal drug discovery. Any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements and are based upon Exelixis’ current plans, assumptions, beliefs, expectations, estimates and projections. Forward-looking statements involve risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result of these risks and uncertainties, which include, without limitation: the level of costs associated with Exelixis’ commercialization, research and development, in-licensing or acquisition of product candidates, and other activities; uncertainties inherent in the drug discovery and product development process; Exelixis’ dependence on its relationship with Catalent, including Catalent’s adherence to its obligations under the collaboration, option and exclusive license agreement and the level of Catalent’s assistance to Exelixis in completing clinical trials, pursuing regulatory approvals or successfully commercializing partnered compounds in the territories where they may be approved; the continuing COVID-19 pandemic and its impact on Exelixis’ research and development and commercial activities; risks and uncertainties related to regulatory review and approval processes and Exelixis’ compliance with applicable legal and regulatory requirements; Exelixis’ and Catalent’s ability to protect their respective intellectual property rights; market competition; changes in economic and business conditions; and other factors discussed under the caption “Risk Factors” in Exelixis’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 6, 2020, and in Exelixis’ future filings with the SEC. All forward-looking statements in this press release are based on information available to Exelixis as of the date of this press release, and Exelixis undertakes no obligation to update or revise any forward-looking statements contained herein, except as required by law.

Exelixis, the Exelixis logo, CABOMETYX, COMETRIQ and COTELLIC are registered U.S. trademarks.

MINNEBRO is a Japanese trademark.

Catalent and SMARTag are registered trademarks of Catalent Pharma Solutions, Inc. or its affiliates or subsidiaries in the United States and other countries.

Contacts

Exelixis
Investors Contact:

Susan Hubbard

Executive Vice President,

Public Affairs & Investor Relations

(650) 837-8194

shubbard@exelixis.com

Media Contact:
Hal Mackins

For Exelixis, Inc.

(415) 994-0040

hal@torchcommunications.com

Catalent

Media Contact:
Chris Halling

+44 (0)7580 041073

chris.halling@catalent.com

Richard Kerns

+44 (0) 161 728 5880

richard@nepr.agency

Categories
Healthcare

Humanigen expands partnership with Catalent biologics to manufacture investigational COVID-19 therapeutic candidate lenzilumab

  • Humanigen’s investigational monoclonal antibody, lenzilumab, was developed using Catalent’s proprietary GPEx® cell line development technology
  • Expanded partnership established product supply for lenzilumab, an investigational Phase 3 product for COVID-19
  • Catalent’s OneBio® integrated biologics suite expected to accelerate development, manufacturing and supply of lenzilumab for clinical trial use in COVID-19 patients and potential commercialization

SOMERSET, N.J. & BURLINGAME, Calif.–(BUSINESS WIRE)–Catalent and Humanigen, Inc. (HGEN) (“Humanigen”) today announced the expansion of their relationship, under which Catalent will provide development, manufacturing and commercialization services for lenzilumab, Humanigen’s proprietary Humaneered® anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody.

Catalent is the leading global provider of advanced delivery technologies, development, manufacturing and clinical supply solutions for drugs, biologics, cell and gene therapies and consumer health products. Humanigen is a clinical stage biopharmaceutical company focused on preventing and treating cytokine storm with lenzilumab, the company’s lead therapeutic candidate.

Mayo Clinic recently announced data on the first clinical use of lenzilumab in 12 patients with severe and critical COVID-19 pneumonia, the majority of whom showed rapid recovery and hospital discharge. A Phase 3 study is currently underway evaluating hospitalized COVID-19 patients.

“Based on lenzilumab’s promising clinical data, we are pleased to expand our relationship with Catalent to solidify our ability to manufacture and supply lenzilumab,” commented Cameron Durrant, MD, MBA, Chief Executive Officer of Humanigen. “If we are able to secure FDA approvals or Emergency Use Authorization, Catalent Biologics’ deep expertise and integrated OneBio solution will accelerate our ability to get this therapy to patients that need it most.”

Catalent has partnered closely with Humanigen to develop and supply lenzilumab for clinical trials,” commented Karen Flynn, President of Catalent Biologics and Chief Commercial Officer. “The experience we already have with lenzilumab, and our OneBio integrated offering from development to supply, make Catalent uniquely suited to support Humanigen in the journey to make this promising therapy available to COVID-19 patients as soon as possible following receipt of regulatory approvals.”

To date, Catalent Biologics has provided early-stage development and clinical cGMP drug substance manufacturing for lenzilumab at its facility in Madison, Wisconsin to support Humanigen’s ongoing clinical trials across various disease categories. Under the expanded partnership, Catalent is also providing clinical supply support for Humanigen’s Phase 3 potential registration study in COVID-19 from its Philadelphia facility.

Lenzilumab was originally manufactured in Catalent’s Madison facility using Catalent Biologics’ proprietary GPEx® cell line development technology. As part of the expanded partnership, Catalent intends to provide additional drug substance clinical supply for Humanigen’s clinical trials, Expanded Access Program (EAP), as well as additional late-stage development and clinical and potential commercial drug substance manufacturing and vial filling at its Madison and Bloomington, Indiana, sites.

Catalent Biologics’ Madison facility provides development and drug substance manufacturing, including GPEx cell line development, process development, process validation, formulation development, and clinical and commercial cGMP manufacturing. Its Bloomington facility has deep expertise in sterile formulation, with drug substance development and manufacturing and drug product fill/finish capacity across liquid and lyophilized vials, prefilled syringes, and cartridges as well as primary and secondary packaging.

Catalent’s OneBio Suite is an integrated solution for the development, manufacturing, and supply of biologic drugs. Launched in May 2019, the suite of offerings is designed to integrate activities and accelerate timelines, reduce risk and simplify development with a single contract, program manager, and development timeline from cell line development to supply, with harmonized quality systems.

About Humanigen, Inc.

Humanigen, Inc. is developing its portfolio of clinical and pre-clinical therapies for the treatment of cancers and infectious diseases via its novel, cutting-edge GM-CSF neutralization and gene-knockout platforms. We believe that our GM-CSF neutralization and gene-editing platform technologies have the potential to reduce the inflammatory cascade associated with coronavirus infection. The company’s immediate focus is to prevent or minimize the cytokine release syndrome that precedes severe lung dysfunction and ARDS in serious cases of SARS-CoV-2 infection. The company is also focused on creating next-generation combinatory gene-edited CAR-T therapies using strategies to improve efficacy while employing GM-CSF gene knockout technologies to control toxicity. In addition, the company is developing its own portfolio of proprietary first-in-class EphA3-CAR-T for various solid cancers and EMR1-CAR-T for various eosinophilic disorders. The company is also exploring the effectiveness of its GM-CSF neutralization technologies (either through the use of lenzilumab as a neutralizing antibody or through GM-CSF gene knockout) in combination with other CAR-T, bispecific or natural killer (NK) T cell engaging immunotherapy treatments to break the efficacy/toxicity linkage, including to prevent and/or treat graft-versus-host disease (GvHD) in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). Additionally, Humanigen and Kite, a Gilead Company, are evaluating lenzilumab in combination with Yescarta® (axicabtagene ciloleucel) in patients with relapsed or refractory large B-cell lymphoma in a clinical collaboration. For more information, visit www.humanigen.com.

About Catalent Biologics

Catalent Biologics is a global leader in development, manufacturing and analytical services for new biological entities, cell and gene therapies, biosimilars, sterile injectables, and antibody-drug conjugates. With over 20 years of proven expertise, Catalent Biologics has worked with 600+ mAbs and 80+ proteins, produced 13 biopharmaceutical drugs using GPEx® cell line development technology, and manufactured 35+ commercially approved products. Catalent Cell & Gene Therapy, a unit of Catalent Biologics, is a full-service partner for adeno-associated virus (AAV) vectors and CAR-T immunotherapies, with deep experience in viral vector scale-up and production. Catalent recently acquired MaSTherCell, adding expertise in autologous and allogeneic cell therapy development and manufacturing. Catalent Cell & Gene Therapy has produced 100+ cGMP batches across 70+ clinical and commercial programs. For more information, visit biologics.catalent.com.

About Catalent

Catalent is the leading global provider of advanced delivery technologies, development, manufacturing, and clinical supply solutions for drugs, biologics, cell and gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs over 13,500 people, including over 2,400 scientists and technicians, at more than 40 facilities, and in fiscal year 2019 generated over $2.5 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com.

More products. Better treatments. Reliably supplied.™

Humanigen’s Forward-Looking Statements

This release contains forward-looking statements. Forward-looking statements reflect management’s current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct and you should be aware that actual events or results may differ materially from those contained in the forward-looking statements. Words such as “will,” “expect,” “intend,” “plan,” “potential,” “possible,” “goals,” “accelerate,” “continue,” and similar expressions identify forward-looking statements, including, without limitation, statements regarding our expectations for the Phase III study and the potential future development of lenzilumab to minimize or reduce the severity of lung dysfunction associated with severe and critical COVID-19 infections or to be approved by FDA for such use or to help CAR-T reach its full potential or to deliver benefit in preventing GvHD. Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in our lack of profitability and need for additional capital to conduct the Phase III study and grow our business; our dependence on partners to further the development of our product candidates; the uncertainties inherent in the development and launch of any new pharmaceutical product; the outcome of pending or future litigation; and the various risks and uncertainties described in the “Risk Factors” sections and elsewhere in the Company’s periodic and other filings with the Securities and Exchange Commission.

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should not place undue reliance on any forward-looking statements, which speak only as of the date of this release. We undertake no obligation to revise or update any forward-looking statements made in this press release to reflect events or circumstances after the date hereof or to reflect new information or the occurrence of unanticipated events, except as required by law.

Contacts

Chris Halling

+44 (0)7580 041073

chris.halling@catalent.com

Richard Kerns

+44 (0) 161 728 5880

richard@nepr.agency