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Monday, January 10, 2022

BioNTech, Crescendo Biologics to Collaborate on Precision Immunotherapies

 

  • Collaboration leverages BioNTech’s proprietary multimodal immunotherapy expertise with Crescendo’s proprietary Humabody® VH platform to develop precision immunotherapies, including mRNA-based antibodies and engineered cell therapies against targets selected by BioNTech

  • BioNTech will hold exclusive worldwide development and commercialization rights to all immunotherapies arising from the collaboration

  • Crescendo will receive $40 million upfront, including a cash payment and an equity investment from BioNTech, as well as research funding, and will be eligible to receive development, regulatory and commercial milestone payments up to a total of more than $750 million, plus tiered royalties on global net sales

HALOZYME PROVIDES 2022 FINANCIAL GUIDANCE AND OUTLOOK

 2022 Revenue Guidance of $530 to $560 Million Representing 23-26% Growth over Expected 2021 Revenue -

- 2022 Recurring Revenue from Royalties Projected to Grow by Approximately 50% over Record Royalties in 2021 to Approximately $300 Million -

- 2022 GAAP Operating Income Guidance of $350 to $380 Million Representing 32-36% Growth over Expected 2021 GAAP Operating Income -

- 2022 GAAP Diluted EPS Guidance of $1.90 to $2.05 and 2022 Non-GAAP Diluted EPS Guidance of $2.05 to $2.20 -

"Halozyme had another strong year of financial performance in 2021 with record revenues and profitability driven by strong growth of our wave 2 partner products including the subcutaneous forms of DARZALEX® and Phesgo®," said Dr. Helen Torley, president and chief executive officer. "Also in 2021, we made substantial progress expanding the future opportunity set for our ENHANZE® technology. We signed an exciting new collaboration agreement with ViiV Healthcare to advance the use of our technology in infectious disease and small molecule applications. In 2022, we project at least four new products utilizing ENHANZE® will enter Phase 1 development, resulting in at least twenty partner programs in our pipeline. We look forward to strong continued total and royalty revenue growth, advancement of at least five ENHANZE® partner programs into Phase 2 and 3 development, and potential new ENHANZE® collaborations and new target nominations. We are also making strategic investments to further drive revenue growth and extend revenue durability. These include investments to expand robust API supply of high yield ENHANZE® and development of a new rHuPH20, with extended room temperature stability, and with patent protection to 2032 in Europe and 2034 in the US."

Anticipated 2022 Key Events:

  • Projected growth of approximately 50% in the Company's high-margin, recurring revenue stream from royalties to approximately $300 million driven by continued uptake of wave 2 launch products, subcutaneous DARZALEX® (daratumumab) and Phesgo® (pertuzumab, trastuzumab and hyaluronidase) utilizing ENHANZE® technology;

  • At least five new Phase 2/3 starts for existing ENHANZE® programs;

  • At least four new products utilizing ENHANZE® entering Phase 1 development by the Company's collaboration partners resulting in at least 20 products in development by end of 2022, compared to 16 at the end of 2021;

  • Data from ENHANZE® collaboration partner argenx SE for Phase 3 study of efgartigimod SC utilizing ENHANZE® technology in myasthenia gravis expected in the first half of 2022;

  • Investments to further drive revenue growth and extend revenue durability, including:

  • At least one new global collaboration and license agreement for ENHANZE®, which is included in Company revenue guidance;

  • Up to $250 million in share repurchases, inclusive of $150 million accelerated share repurchase announced in December 2021, as part of the $750 million three-year share repurchase plan authorized by Halozyme's board of directors in December 2021 demonstrating the Company's continued commitment to a balanced capital allocation strategy.

2022 Financial Guidance:

Revenue

For 2022, Halozyme expects total revenue of $530 million to $560 million, representing growth of 23-26% over 2021 expected total revenue. The Company expects revenue from royalties to increase approximately 50% over expected revenue from royalties in 2021, to approximately $300 million. Product sales related to API and revenue under collaborative agreements are expected to be overall similar to 2021.

Operating Income

For 2022, Halozyme expects GAAP operating income of $350 million to $380 million, representing growth of 32-36% over 2021 expected GAAP operating income, resulting in operating margins greater than 65%. This strong growth is anticipated despite higher projected operating expenses excluding cost of product sales resulting from the Company investing in new initiatives to drive revenue growth and extend revenue durability.

Net Income and Earnings per Share

The Company notes that 2022 will be the first full fiscal year in which Halozyme will record income tax expense as part of its income statement, reflecting Halozyme's strong profitability.

Net Income

For 2022, Halozyme expects GAAP net income of $270 million to $295 million and Non-GAAP net income of $290 million to $315 million.1

Earnings per Share

For 2022, Halozyme expects GAAP diluted earnings per share of $1.90 to $2.05. In 2021 the Company recorded a one-time, non-cash income tax benefit of $142 million or $0.97 per share, related to the reversal of its tax valuation allowance in the third quarter.

Non-GAAP diluted earnings per share are expected to be $2.05 to $2.20.1 The company notes that 2022 will be the first full fiscal year in which the company will record income tax expense, projected to be $0.55-$0.60 per share.

The Company's earnings per share guidance does not consider the impact of potential future share repurchases.

Table 1. 2022 Financial Guidance


Guidance Range

Net Revenue

$530 to $560 million

GAAP Operating Income

$350 to $380 million

GAAP Net Income

$270 to $295 million

Non-GAAP Net Income

$290 to $315 million1

GAAP Diluted EPS

$1.90 to $2.05

Non-GAAP Diluted EPS

$2.05 to $2.201

Footnotes:
1. Reconciliations between GAAP reported and non-GAAP financial information and adjusted guidance measures are provided at the end.

https://finance.yahoo.com/news/halozyme-provides-2022-financial-guidance-130000339.html

CareDx Reports Prelim Revenue Results for Fourth Quarter and Full Year 2021

 Fourth Quarter Highlights

  • Revenue expected to be between $78.6 million to $79.0 million, representing year-over-year growth of 34% to 35%

  • Testing volume greater than 41,900, including approximately 700 tests for AlloSure® Lung

  • Achieved CLIA validation of AlloMap® Kidney

  • Acquired MedActionPlan and The Transplant Pharmacy

  • Record testing volume and revenues despite lower sequential transplant procedure volumes

Full Year 2021 Highlights

  • Revenue expected to be in the range of $295.7 million to $296.1 million, representing year-over-growth of 54%

Preliminary revenue for the three months ended December 31, 2021, is expected to be between $78.6 million and $79.0 million, an increase of approximately 34% to 35% compared with $58.6 million in the fourth quarter of 2020. Testing services revenue for the quarter is expected to be between $68.2 million to $68.6 million, compared with $50.3 million in the same period in 2020. Total AlloSure and AlloMap patient results provided in the quarter were greater than 41,900, which includes approximately 700 AlloSure Lung patient results. Product revenue in the three months ended December 31, 2021, is expected to be $7.7 million, compared to $5.9 million in the same period in 2020. Digital and other revenue in the fourth quarter of 2021 is expected to be $2.7 million, compared to $2.4 million in the same period in 2020. Digital revenues include approximately $0.3 million revenue contribution from newly acquired businesses, MedActionPlan and The Transplant Pharmacy.

Preliminary revenue for the full year ended December 31, 2021, is expected to be between $295.7 million and $296.1 million, an increase of approximately 54% compared with $192.2 million in 2020. Testing services revenue for the year ended December 31, 2021, is expected to be between $258.9 million to $259.3 million, compared with $163.6 million in 2020. Product revenue for the full year 2021 is expected to be $26.8 million, compared to $19.3 million in 2020. Digital and other revenue for the full year 2021 is expected to be $10.0 million, compared to $9.3 million in 2020.

Allogene: FDA removes clinical hold

 

  • Investigation Confirmed the Chromosomal Abnormality in a Single Patient was Not Observed in Any AlloCAR T Product and Not Related to Allogene Manufacturing Process or TALEN® Gene Editing

  • Clinical Trials Across the AlloCAR T Platform to Resume

  • Pivotal Phase 2 Trial of ALLO-501A in Relapsed/Refractory Large B Cell Lymphoma Expected to Commence in Mid-Year 2022 Pending FDA Discussions

  • Company to Host Conference Call Today at 8:30 am PT/11:30 am ET

Conference Call and Webcast Details
Allogene will host a live conference call and webcast today at 8:30 a.m. Pacific Time / 11:30 a.m. Eastern Time to provide a business update. To access the live conference call by telephone, please dial 1 (866) 940-5062 (U.S.) or 1 (409) 216-0618 (International). The conference ID number for the live call is 8598466. The webcast will be made available on the Company's website at www.allogene.com under the Investors tab in the News and Events section. Following the live audio webcast, a replay will be available on the Company's website for approximately 30 days.

Veru gets fast track in metastatic breast cancer

 FDA Fast Track Designation is Intended to Expedite the Development and Review of New Drugs to Treat Serious Medical Conditions that Fill Unmet Medical Need --

-- Phase 3 ARTEST Registration Study of Enobosarm in Patients with AR+ ER+ HER2- Metastatic Breast Cancer Who Have Shown Previous Disease Progression on a Nonsteroidal AI, Fulvestrant, and a CDK 4/6 Inhibitor is Currently Enrolling --

https://finance.yahoo.com/news/veru-announces-fda-grant-fast-133000315.html

Adaptive Biotechnologies Announces Preliminary, Unaudited 2021 Revenue

 Adaptive Biotechnologies Corporation (Nasdaq: ADPT) today reported preliminary, unaudited revenue for the year ended December 31, 2021. Total revenue for the year ended December 31, 2021 is estimated to be in the range of $153 million to $154 million, representing an approximate increase of 56% at the mid-point of the range compared to $98.4 million for the year ended December 31, 2020.

“The Adaptive team delivered strong results in 2021, setting the stage to accelerate our immune medicine and MRD business areas,” said Chad Robins, chief executive officer and co-founder of Adaptive Biotechnologies. “Our goal is to transform the genetics of the adaptive immune system into novel diagnostics and therapeutics. We are in a strong position and poised for sustainable future growth.”

These preliminary, unaudited results are based on management’s initial analysis of operations for the year ended December 31, 2021 and are subject to change. Adaptive Biotechnologies expects to issue full financial results for the year ended December 31, 2021 on or around February 15, 2022.

https://finance.yahoo.com/news/adaptive-biotechnologies-announces-preliminary-unaudited-133000614.html

Jazz Pharma Announces $5 billion revenue target for 2025

 Confirms 2021 revenue expected to be within previously announced guidance range, exceeding $3 billion

Company to present at 40th Annual J.P. Morgan Healthcare Conference today, January 10, 2022, at 2:15 - 2:55 p.m. ET / 7:15 - 7:55 p.m. GMT

Presentation and Webcast
Bruce Cozadd will provide a corporate overview and discuss the Company's Vision 2025 during the virtual presentation at the 40th Annual J.P. Morgan Healthcare Conference from 2:15 – 2:55 p.m. ET / 7:15 – 7:55 p.m. GMT on Monday, January 10, 2022.

A live audio webcast of the presentation may be accessed from the Investors section of the Jazz Pharmaceuticals website at www.jazzpharma.com. Please connect to the website prior to the start of the presentation to ensure adequate time for any software downloads that may be necessary to listen to the webcast. A replay of the webcast will be available on the website for 30 days.

https://finance.yahoo.com/news/jazz-pharmaceuticals-announces-vision-2025-123000381.html