Arrowhead Pharmaceuticals Reports Fiscal 2022 First Quarter Results

On February 2, 2022 Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) reported financial results for its fiscal year ended December 31, 2021 (Press release, Arrowhead Research Corporation, FEB 2, 2022, View Source [SID1234607624]). The company is hosting a conference call today, February 2, 2022, at 4:30 p.m. ET to discuss the results.

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Conference Call and Webcast Details

Investors may access a live audio webcast on the Company’s website at View Source For analysts that wish to participate in the conference call, please dial 855-215-6159 or 315-625-6887 and provide Conference ID 9844328.

A replay of the webcast will be available on the company’s website approximately two hours after the conclusion of the call and will remain available for 90 days. An audio replay will also be available approximately two hours after the conclusion of the call and will be available for 3 days. To access the audio replay, dial 855-859-2056 or 404-537-3406 and provide Conference ID 9844328.

Selected Recent Events

Initiated the PALISADE Phase 3 clinical study to evaluate the efficacy and safety of ARO-APOC3, Arrowhead’s investigational RNA interference (RNAi) therapeutic designed to inhibit the production of apolipoprotein C-III (APOC3), a key regulator of triglyceride metabolism, in adults with familial chylomicronemia syndrome

Advanced two new investigational candidates that utilize Arrowhead’s pulmonary targeted TRiMTM platform into CTA enabling studies with both on track to file CTAs in the

first half of 2022. Both candidates are designed to treat various muco-obstructive and inflammatory pulmonary conditions

ARO-RAGE, an investigational RNAi therapeutic designed to inhibit the production of Receptor for Advanced Glycation End products (RAGE)

ARO-MUC5AC, an investigational RNAi therapeutic designed to inhibit the production of mucin 5AC (MUC5AC)

Completed a transaction to purchase 13 acres of land in the Verona Technology Park in Verona, WI, which is planned to be the site of an approximately 140,000 square foot drug manufacturing facility and an approximately 115,000 square foot laboratory and office facility to support process development and analytical activities

Entered into an exclusive license agreement with GlaxoSmithKline (GSK) under which GSK will develop and commercialize ARO-HSD, Arrowhead’s investigational RNAi therapeutic in a Phase 1/2 trial that is currently being developed as a treatment for patients with nonalcoholic steatohepatitis (NASH)

Presented additional Phase 1/2 clinical data on ARO-APOC3 at the American Heart Association (AHA) Scientific Sessions 2021

Presented new clinical data at The Liver Meeting, the Annual Meeting of the American Association for the Study of Liver Disease (AASLD), for the following investigational candidates:

JNJ-73763989 (JNJ-3989), formerly called ARO-HBV, being developed by collaborator Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson

ARO-HSD, the investigational RNAi therapeutic being developed as a treatment for patients with NASH and recently licensed to GSK

ARO-AAT, also known as TAK-999, the investigational RNAi therapeutic being co-developed with Takeda Pharmaceutical Company Limited as a treatment for the rare genetic liver disease associated with alpha-1 antitrypsin deficiency

Alvotech Enters Exclusive Global Licensing Agreement with BiosanaPharma for Co-Development of a Proposed Biosimilar (AVT23) to Xolair® (Omalizumab)

On February 2, 2022 Alvotech Holdings S.A. ("Alvotech"), a global biopharmaceutical company focused solely on the development and manufacture of biosimilar medicines for patients worldwide, reported that it has entered into an exclusive global licensing agreement with BiosanaPharma to co-develop AVT23 (also called BP001), a proposed biosimilar to Xolair (omalizumab) (Press release, Alvotech, FEB 2, 2022, View Source [SID1234607641]).

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Global sales of Xolair in 2020 reached $3.3 billion. AVT23 will be produced using BiosanaPharma’s proprietary 3C process technology, a fully continuous operation designed to allow for highly productive, low-cost manufacturing.

"This transaction underscores Alvotech’s comprehensive approach to the biosimilars market," said Mark Levick, CEO of Alvotech. "Our pure-play biosimilars approach allows the Alvotech platform to be highly opportunistic in not only developing products in-house, but also through in-licensing and co-developing attractive products through partnerships with premier companies like BiosanaPharma."

"We are delighted at this collaboration with Alvotech as their platform can enable global distribution of our lead product, if approved," said Ard Tijsterman, CEO of BiosanaPharma. "Our 3C process technology is designed to make products more affordable and to improve patient access, a key goal for both BiosanaPharma and Alvotech."

"The cooperation between our companies demonstrates the ability of our platform to rapidly scale our portfolio," said Anil Okay, Chief Commercial Officer of Alvotech. "This product had been on our wish list for some time and expands the breadth and potential of our future offerings in primary care."

Under terms of the agreement, Alvotech will receive exclusive global rights for AVT23, a proposed biosimilar to Xolair. BiosanaPharma will receive an upfront payment and will be eligible for certain tiered royalties. BiosanaPharma and Alvotech will jointly further the development of AVT23, which is currently in late-stage development. BiosanaPharma has completed a pharmacokinetic (PK) study showing that AVT23’s bioavailability, safety, tolerability and immunogenicity were comparable to those of Xolair.

On December 7, 2021, Alvotech and Oaktree Acquisition Corp. II (NYSE: OACB.U, OACB, OACB WS), a special purpose acquisition company sponsored by an affiliate of Oaktree Capital Management, L.P., announced they had entered into a definitive business combination agreement. Upon completion of the transaction, the combined company’s securities are expected to be traded on NASDAQ under the symbol "ALVO."

About AVT23

AVT23 is a proposed biosimilar to Xolair (omalizumab). Omalizumab is an antibody that targets free IgE; it is used to improve the control of severe persistent allergic asthma, for chronic (long-term) spontaneous urticaria (itchy rash) in patients with elevated IgE who do not respond to treatment with antihistamines and to treat nasal polyps in people 18 years of age and older when medicines to treat nasal polyps called nasal corticosteroids have not worked well enough. Xolair, the only currently approved product containing omalizumab, was first approved in 2003. AVT23 is an investigational compound and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed.

Fate Therapeutics to Present at Upcoming February Investor Conferences

On February 2, 2022 Fate Therapeutics, Inc. (the "Company" or "Fate Therapeutics") (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for patients with cancer, reported that the Company will present at the following upcoming investor conferences (Press release, Fate Therapeutics, FEB 2, 2022, View Source [SID1234607609]):

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4th Annual Guggenheim Oncology Day available on demand on Wednesday, February 9, 2022 at 11:00 AM ET
SVB Leerink 2022 Global Healthcare Conference on demand on Wednesday, February 16, 2022 at 3:00 PM ET
A live webcast, if recorded, of each presentation can be accessed under "Events & Presentations" in the Investors section of the Company’s website at www.fatetherapeutics.com. The archived webcast will be available on the Company’s website shortly after the event.

Thermo Fisher Scientific Reports Fourth Quarter and Full Year 2021 Results

On February 2, 2022 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported its financial results for the fourth quarter and full year ended December 31, 2021 (Press release, Thermo Fisher Scientific, FEB 2, 2022, View Source [SID1234607625]).

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Fourth Quarter and Full Year 2021 Highlights

Fourth quarter revenue was $10.70 billion.
Fourth quarter GAAP diluted earnings per share (EPS) was $4.17.
Fourth quarter adjusted EPS was $6.54.
Full year revenue grew 22% to $39.21 billion.
Full year GAAP diluted EPS increased 22% to $19.46.
Full year adjusted EPS increased 28% to $25.13.
Built on industry leadership throughout the year, supporting our customers, delivering outstanding results, and investing to further strengthen the long-term growth trajectory of the company.
Achieved very strong results in the fourth quarter, with excellent growth in the base business and $2.45 billion of COVID-19 response revenue.
Delivered another year of high-impact innovation, highlighted by the HyPerforma DynaDrive Single-Use Bioreactor, the Thermo Scientific Orbitrap Exploris Gas Chromatography-Mass Spectrometers, and the Thermo Scientific Helios 5EXL Wafer DualBeam scanning electron microscope to support the development of increasingly smaller and more complex semiconductors. During the quarter, we launched the Thermo Scientific Orbitrap Exploris MX mass detector providing high throughput analysis to improve the development and production of biopharmaceuticals and the Applied Biosystems QuantStudio 7 Pro Dx Real-Time PCR system which enables clinical testing laboratories to accelerate molecular diagnostics.
Accelerated investments in capacity and capabilities, investing $2.5 billion in 2021 to meet short- and long-term customer demand. During the year we added capacity for bioproduction, sterile fill-finish services, laboratory products as well as enzymes and nucleotides. We also continued to build our industry-leading scale in high-growth and emerging markets during the year, including an increase in our single-use bioproduction manufacturing in Asia Pacific and opening a Customer Innovation Center in South Korea, focused on the semiconductor industry.
Continued to advance our environmental, social and governance (ESG) priorities throughout the year. Building on our environmental sustainability initiatives, we committed to reach net-zero carbon emissions by 2050. Highlights from our Foundation for Science include supporting more than 100,000 students globally through our STEM education programs and supporting life-science researchers in developing countries. We also published and raised funding through our Sustainable Financing Framework supporting our commitment to doing business the right way and funding projects that align with the United Nations Sustainable Development Goals (UN SDGs). Throughout the year, Thermo Fisher Scientific was recognized as a leader in our industry and in the workplace and, in the fourth quarter, Forbes recognized the company on its list of the World’s Top Female-Friendly Companies.
Very active year of capital deployment, investing $24 billion in strategic acquisitions. This was highlighted by the addition of PPD, Inc., a leading provider of clinical research services for the biopharma industry, and, just before year end, completing the acquisition of PeproTech, a leading provider of recombinant proteins. We also returned $2.4 billion of capital to shareholders through stock buybacks and dividends.
"We had an outstanding 2021, as we continued to execute our proven growth strategy, powered by our PPI Business System, and operated with speed at scale to help our customers and governments around the world advance their important work," said Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher Scientific. "We exceeded the goals we set out to accomplish in 2021 and delivered for all of our stakeholders."

Casper added, "Thanks to our incredible team, we are entering 2022 with great momentum. Our exceptional performance has enabled us to further strengthen our long-term competitive position by significantly accelerating our growth strategy through enhanced customer relationships and significant investments in commercial capabilities, innovation, capacity expansion and acquisitions, to ensure an even brighter future."

Fourth Quarter 2021

Revenue for the quarter grew 1% to $10.70 billion in 2021, versus $10.55 billion in 2020. Organic revenue decreased 4%, acquisitions increased revenue by 6% and currency translation decreased revenue by 1%. Organic growth from the base business was 8%. COVID-19 response revenue was $2.45 billion.

GAAP Earnings Results

GAAP diluted EPS in the fourth quarter of 2021 was $4.17, versus $6.24 in the same quarter last year. GAAP operating income for the fourth quarter of 2021 was $2.54 billion, compared with $3.07 billion in the year-ago quarter. GAAP operating margin was 23.7%, compared with 29.1% in the fourth quarter of 2020.

Non-GAAP Earnings Results

Adjusted EPS in the fourth quarter of 2021 was $6.54, versus $7.09 in the fourth quarter of 2020. Adjusted operating income for the fourth quarter of 2021 was $3.16 billion, compared with $3.51 billion in the year-ago quarter. Adjusted operating margin was 29.5%, compared with 33.3% in the fourth quarter of 2020.

Full Year 2021

Revenue for the full year grew 22% to $39.21 billion in 2021, versus $32.22 billion in 2020. Organic revenue growth was 17%, acquisitions increased revenue by 3%, and currency translation increased revenue by 2%. Organic growth from the base business was 14%. COVID-19 response revenue was $9.23 billion.

GAAP Earnings Results

GAAP diluted EPS for the full year increased 22% to $19.46, versus $15.96 in 2020. GAAP operating income for 2021 grew to $10.03 billion, compared with $7.79 billion a year ago. GAAP operating margin increased to 25.6% in 2021, compared with 24.2% in 2020.

Non-GAAP Earnings Results

Adjusted EPS for the full year rose 28% to $25.13, versus $19.56 in 2020. Adjusted operating income for 2021 grew 27% compared with 2020 and adjusted operating margin increased to 31.0%, compared with 29.7% a year ago.

Annual Guidance for 2022

The company will provide updated 2022 financial guidance during its earnings conference call this morning at 8:30 a.m. Eastern time.

Use of Non-GAAP Financial Measures

Adjusted EPS, adjusted net income, adjusted operating income, adjusted operating margin, free cash flow, organic revenue growth and base business organic revenue growth are non-GAAP measures that exclude certain items detailed after the tables that accompany this press release, under the heading "Supplemental Information Regarding Non-GAAP Financial Measures." The reconciliations of GAAP to non-GAAP financial measures are provided in the tables that accompany this press release.

Conference Call

Thermo Fisher Scientific will hold its earnings conference call today, February 2, at 8:30 a.m. Eastern time. To listen, dial (844) 200-6205 within the U.S. or (929) 526-1599 outside the U.S. The access code is 986581. You may also listen to the call live on our website, www.thermofisher.com, by clicking on "Investors." You will find this press release, including the accompanying reconciliation of non-GAAP financial measures and related information, in that section of our website under "Financials." An audio archive of the call will be available under "News and Events" through Friday, February 11, 2022.

Castle Biosciences Named a Winner of the 2022 Top Workplaces USA Award

On February 2, 2022 Castle Biosciences, Inc. (Nasdaq: CSTL), a leader in transforming disease management and improving patient outcomes through innovative diagnostics, reported that it has received a 2022 Top Workplaces USA award from Energage (Press release, Castle Biosciences, FEB 2, 2022, View Source [SID1234607642]). The Top Workplaces USA award celebrates organizations with 150 or more U.S. employees that have built exceptional workplace cultures. Recipients of the Top Workplaces USA award are chosen solely on employee feedback gathered through an employee engagement survey.

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"From the beginning, we have strived to create something different at Castle – a place where we make decisions based on what is best for people: the patients who benefit from the information that our advanced diagnostic tests provide; the clinicians who use our tests to inform their disease management decisions; and our employees, the valued members of our Castle family," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "We are incredibly honored to have received the Top Workplaces USA award, and credit our fantastic employees, who embody our values of integrity, transparency, collaboration and innovation. At Castle, we understand that the true value of our company comes from our talented employees and believe that our focus on maintaining a positive culture helps us attract top talent, people who are willing to go the extra mile to make a difference in patient care."

Castle has received numerous awards recognizing its strong company culture, innovation, leadership and overall company performance. Recent awards include: Inc.’s Best-Led Companies of 2021; the Houston Chronicle’s 2021 Top Workplaces; the Houston Chronicle’s "CHRON 100" list of the 100 most successful publicly traded companies in Houston in 2020 and 2021; a 2021 MedTech Breakthrough Award for the "Best New Technology Solution for Oncology" recognizing the Company’s DecisionDx-SCC and DecisionDx DiffDx-Melanoma gene expression profile tests; a Healthcare Technology Report Top 100 Healthcare Technology Company in 2021; and a 2019 Technology Innovation in Melanoma Award from the American Skin Association.