Karyopharm to Report Fourth Quarter and Full Year 2021 Financial Results on February 8, 2022

On February 2, 2022 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported it will report fourth quarter and full year 2021 financial results on Tuesday, February 8, 2022 (Press release, Karyopharm, FEB 2, 2022, View Source,-2022 [SID1234607627]). Karyopharm’s management team will host a conference call and audio webcast at 8:30 a.m. ET on Tuesday, February 8, 2022, to discuss the financial results and other company updates.

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To access the conference call, please dial (888) 349-0102 (local) or (412) 902-4299 (international) at least 10 minutes prior to the start time and ask to be joined into the Karyopharm Therapeutics call. A live audio webcast of the call, along with accompanying slides, will be available under "Events & Presentations" in the Investor section of the Company’s website, View Source An archived webcast will be available on the Company’s website approximately two hours after the event.

Boston Scientific Announces Results For Fourth Quarter and Full Year 2021

On February 2, 2022 Boston Scientific Corporation (NYSE: BSX) reported that generated net sales of $3.127 billion during the fourth quarter of 2021, growing 15.4 percent on a reported basis, 16.9 percent on an operational1 basis and 15.1 percent on an organic2 basis, all compared to the prior year period (Press release, Boston Scientific, FEB 2, 2022, View Source [SID1234607626]). The company reported GAAP net income available to common stockholders of $80 million or $0.06 per share (EPS), compared to $196 million or $0.14 per share a year ago and achieved adjusted EPS of $0.45 for the period, compared to $0.23 a year ago.

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For the full year 2021, the company generated net sales of $11.888 billion, growing 19.9 percent on a reported basis, 18.7 percent on an operational basis and 18.9 percent on an organic basis, all compared to the prior year period. The company reported GAAP net income (loss) available to common stockholders of $985 million or $0.69 per share, compared to $(115) million or $(0.08) per share a year ago, and delivered full year adjusted EPS of $1.63, compared to $0.96 a year ago.

"I’m very pleased with our strong fourth quarter and full year results, thanks to our team’s commitment and resilience in a challenging environment," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "I’m excited about the capabilities we’ve built, and I remain confident in our ability to execute in 2022 and against our long-range plans as we continue delivering meaningful innovations for patients around the world."

Fourth quarter financial results and recent developments:

Reported net sales of $3.127 billion, representing an increase of 15.4 percent on a reported basis, compared to the company’s guidance range of 13 to 17 percent; 16.9 percent on an operational basis; and 15.1 percent on an organic basis, compared to the company’s guidance range of 12 to 16 percent, all compared to the prior year period.
Reported GAAP net income available to common stockholders of $0.06 per share, compared to the company’s guidance range of $0.21 to $0.23 per share, and achieved adjusted EPS of $0.45 per share, compared to the guidance range of $0.43 to $0.45 per share.
Achieved net sales growth in each reportable segment4, compared to the prior year period:
MedSurg: 12.1 percent reported, 13.3 percent operational and 9.4 percent organic
Rhythm and Neuro: 11.8 percent reported, 13.2 percent operational and 6.1 percent organic
Cardiovascular: 25.3 percent reported, 27.0 percent operational and organic
Achieved the following regional5 net sales growth, compared to the prior year period:
U.S.: 19.7 percent reported and operational
EMEA (Europe, Middle East and Africa): 12.3 percent reported and 16.0 percent operational
APAC (Asia-Pacific): 14.3 percent reported and 17.4 percent operational
Emerging Markets3: 30.2 percent reported and 31.6 percent operational
Initiated the MODULAR ATP clinical trial to evaluate the safety, performance and effectiveness of the mCRM Modular Therapy System. The mCRM System consists of two cardiac rhythm management devices intended to work together to coordinate therapy: the EMBLEM MRI Subcutaneous Implantable Defibrillator System and the EMPOWER Modular Pacing System, designed to be the first leadless pacemaker capable of delivering both bradycardia pacing support and antitachycardia pacing (ATP).
Presented positive late-breaking clinical trial data on the COMBO randomized control trial at the 2022 North American Neuromodulation Society (NANS) meeting demonstrating the durable effectiveness of the WaveWriter Spinal Cord Stimulator (SCS) System, capable of delivering combination therapy for the treatment of chronic pain, designed to offer more opportunities to customize SCS therapy and optimize outcomes.
Completed acquisition of Devoro Medical Inc., developer of the WOLF Thrombectomy Platform, an innovative non-console and lytic-free technology which rapidly captures and removes blood clots, complementing the company’s full suite of interventional strategies for thromboemboli.
Commenced limited market release of the AXIOS Stent in China. The device gives physicians the ability to endoscopically manage two serious complications from pancreatitis: symptomatic pseudocysts and walled-off pancreatic necrosis.
Secured from the U.S. Centers for Medicare and Medicaid Services (CMS) a higher-paying Ambulatory Payment Classification for Rezūm Water Vapor Therapy, resulting in a national Medicare average payment increase of ~75 percent when performed as a hospital outpatient procedure or in an ambulatory surgical center for the treatment of benign prostatic hyperplasia (enlarged prostate). Data have confirmed the therapy as an effective, long-term solution for the condition, which affects about half of all men by age 60.
The Barcelona Clinic Liver Cancer (BCLC) prognosis and treatment strategy guidelines for hepatocellular carcinoma (HCC) were updated to include transarterial radioembolization (Y-90), which encompasses TheraSphere Y-90 Glass Microspheres, for very early stage (0) and early stage (A) patients. The recommendations–which are commonly cited to guide clinical-decision making–were updated based on the results of the LEGACY study, which also led to FDA approval of TheraSphere for treatment of HCC.
Received multiple recognitions for corporate social responsibility and employee engagement, including number one health care equipment and services company in the JUST 100 rankings of America’s largest public companies by JUST Capital and CNBC; inclusion among Glassdoor’s Best Places to Work in 2022; and the Catalyst award for the company’s Creating Equal Opportunities for Growth initiative, a global effort to accelerate career advancement and address barriers faced by women and multicultural talent.

1. Operational net sales growth excludes the impact of foreign currency fluctuations.

2. Organic net sales growth excludes the impact of foreign currency fluctuations and net sales attributable to acquisitions and divestitures for which there are less than a full period of comparable net sales.

3. We define Emerging Markets as the 20 countries that we believe have strong growth potential based on their economic conditions, healthcare sectors and our global capabilities. Periodically, we assess our list of Emerging Markets countries, and effective January 1, 2021, modified our list to include the following countries: Brazil, Chile, China, Colombia, Czech Republic, India, Indonesia, Malaysia, Mexico, Philippines, Poland, Russia, Saudi Arabia, Slovakia, South Africa, South Korea, Taiwan, Thailand, Turkey and Vietnam. We have revised prior period amounts to conform to the current year’s presentation which had an immaterial impact on previously reported Emerging Markets net sales.

4. We have three historical reportable segments comprised of Medical Surgical (MedSurg), Rhythm and Neuro, and Cardiovascular, which represent an aggregation of our operating segments that generate revenues from the sale of medical devices (Medical Devices).

5. On March 1, 2021, we completed the sale of the Specialty Pharmaceuticals business. Our consolidated net sales include Specialty Pharmaceuticals up to the date of the closing of the transaction. Specialty Pharmaceuticals net sales were substantially U.S. based and presented as a stand-alone operating segment alongside our Medical Device reportable segments.

Amounts may not add due to rounding. Growth rates are based on actual, non-rounded amounts and may not recalculate precisely.

Net sales growth rates that exclude the impact of foreign currency fluctuations and/or the impact of acquisitions / divestitures are not prepared in accordance with U.S. GAAP.

Amounts may not add due to rounding. Growth rates are based on actual, non-rounded amounts and may not recalculate precisely.

Net sales growth rates that exclude the impact of foreign currency fluctuations and/or the impact of acquisitions / divestitures are not prepared in accordance with U.S. GAAP.


Guidance for Full Year and Q1 2022

The company estimates net sales growth for the full year 2022, versus the prior year period, to be in a range of approximately 6 to 8 percent on both a reported basis and organic basis. Full year organic net sales guidance excludes the impact of foreign currency fluctuations and net sales attributable to acquisitions and divestitures for which there are less than a full period of comparable net sales. The company estimates EPS on a GAAP basis in a range of $0.94 to $1.04 and adjusted EPS, excluding certain charges (credits) of $1.73 to $1.79.

The company estimates net sales growth for the first quarter of 2022, versus the prior year period, to be in a range of approximately 5 to 8 percent on both a reported and organic basis. First quarter organic guidance excludes the impact of foreign currency fluctuations and net sales attributable to acquisitions and divestitures for which there are less than a full period of comparable net sales. The company estimates EPS on a GAAP basis in a range of $0.16 to $0.20 and adjusted EPS, excluding certain charges (credits) of $0.38 to $0.40.

Conference Call Information

Boston Scientific management will be discussing these results with analysts on a conference call today at 8:00 a.m. ET. The company will webcast the call to interested parties through its website: www.bostonscientific.com. Please see the website for details on how to access the webcast. The webcast will be available for approximately one year on the Boston Scientific website.

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.

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

Exelixis to Webcast Virtual Fireside Chat as Part of the Guggenheim Healthcare Talks Oncology Day on February 9, 2022

On February 2, 2022 Exelixis, Inc. (Nasdaq: EXEL) reported that company management will participate in a fireside chat at the virtual Guggenheim Healthcare Talks Oncology Day on Wednesday, February 9, 2022 at 1:30pm ET / 10:30am PT (Press release, Exelixis, FEB 2, 2022, View Source [SID1234607623]).

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To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the presentation to ensure adequate time for any software download that may be required to listen to the webcast. A replay will also be available at the same location for at least 30 days.