Masimo: 2022 Outlook; to Acquire Sound United

 2022 Financial Guidance

The Company provided the following estimates for its full-year 2022 guidance:

		2022 Guidance(1)
(in millions, except percentages and earnings per share)		GAAP				Non-GAAP
Product revenue		$	1,350.0			$	1,350.0
Percentage growth - as reported			8.9	%			N/A
Percentage growth - constant currency			N/A				9.5	%
Gross margin			66.2	%			66.5	%
Operating margin			23.0	%			24.8	%
Earnings per diluted share		$	4.27			$	4.34
Estimated tax rate			19.4	%			24.0	%
______________ (1) Consistent with prior guidance provided on January 11, 2022.

• Product revenue increasing to $1,350.0 million, which reflects reported growth of 8.9% and constant currency growth of 9.5%;

• GAAP earnings per diluted share increasing to $4.27;

• Non-GAAP earnings per diluted share increasing to $4.34; and

• Included in our full-year 2022 revenue guidance is approximately $7.0 million of year-over-year currency headwinds.

Sound United Transaction

The Company has entered into a definitive merger agreement to acquire Viper Holdings Corporation, which owns Sound United ("Sound United"), a consumer technology company that owns a portfolio of premium brands, including Bowers & Wilkins, Denon, Polk Audio and Marantz. Pursuant to the merger agreement, Masimo will pay approximately $1.025 billion, subject to adjustments, for the acquisition. Masimo intends to finance the acquisition through a combination of cash on hand and borrowings under a new credit facility, and expects the transaction to close in the middle of 2022, subject to customary closing conditions. The transaction is expected to be immediately accretive to Masimo’s non-GAAP earnings per share upon closing. Please refer to the "Masimo Q4 2021 Supplemental Presentation to the Earnings Press Release" for more information about the transaction.

Joe Kiani, Chairman and Chief Executive Officer of Masimo, said "Sound United is a company with a premium consumer technology platform and iconic, universally-recognized brands like Bowers and Wilkins, Denon, Polk Audio and Marantz, as well as an integrated wireless software platform, HEOS, connecting devices and networks in the home. The Sound United transaction aligns with Masimo’s priorities, objectives and vision by advancing our strategy of enabling connected monitoring across both the hospital and home. We see significant opportunities to cross-leverage technologies, bringing Masimo’s clinically superior solutions into the home and on-the-go as well as bringing Sound United’s premium technologies into the hospital to advance our hospital automation connectivity and cloud-based technologies. The technology and expertise within Sound United will serve us well as we aim to augment our Masimo SafetyNet strategy. Their well-established reputation and presence in the home can help us accelerate adoption of our wearables, and integrated, home-based telemedicine solutions."

Following completion of the transaction, the current CEO and President of Sound United, Kevin Duffy, and his leadership team are expected to continue to lead the Sound United business under Masimo, as well as support Masimo’s consumer health business.

Citi is serving as the exclusive financial advisor to Masimo and Paul Hastings LLP is serving as legal counsel.

https://finance.yahoo.com/news/masimo-reports-fourth-quarter-full-210500008.html

Avenue: FDA Advisory Committee Meeting Rejects IV Tramadol

 Avenue Therapeutics, Inc. (NASDAQ: ATXI) (“Avenue”), a company focused on the development of intravenous (“IV”) tramadol for the U.S. market, today announced the outcome of the U.S. Food and Drug Administration (“FDA”) joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee on IV tramadol.

In the final part of the public meeting, the Advisory Committee voted yes or no on the following question: “Has the Applicant submitted adequate information to support the position that the benefits of their product outweigh the risks for the management of acute pain severe enough to require an opioid analgesic in an inpatient setting?” The results are 8 yes votes and 14 no votes.

FDA Advisory Committees provide the FDA with independent advice and non-binding recommendations. The FDA has previously stated that input from an Advisory Committee is needed for the Office of New Drugs (“OND”) to reach a decision on Avenue’s formal dispute resolution request (“FDRR”) and that the OND will respond to Avenue’s FDRR within 30 calendar days after the Advisory Committee meeting.

https://finance.yahoo.com/news/avenue-therapeutics-announces-outcome-fda-030000367.html

Alkermes Reports 2021, Provides Financial Expectations for 2022

 Financial Expectations for 2022

The following financial expectations for 2022 assume improvement in COVID-19 pandemic-related disruptions, beginning in the second quarter. If current disruptions do not decrease as anticipated, or if new COVID-19-related disruptions emerge, the company's ability to meet these expectations could be negatively impacted. These financial expectations also reflect removal of all royalties from worldwide sales of the long-acting INVEGA products beginning in 2022. Alkermes has, to date, only received notice of partial termination relating to royalties from the long-acting INVEGA products in the U.S., after January 2022. Alkermes has not received a notice of termination from Janssen in respect of any markets outside the U.S. However, for financial planning purposes only, the company has decided to remove all royalties related to sales in markets outside the U.S. after May 2022. Alkermes continues to disagree with the position taken by Janssen and is prepared to pursue all options at its disposal to enforce its contractual rights and address any unauthorized use of its intellectual property.

All line items are according to GAAP, except as otherwise noted.

In millions (except per share amounts)		2022 Expectations
Total Revenue		$1,000 – $1,090
VIVITROL Net Sales		$355 – $385
ARISTADA Net Sales		$290 – $320
LYBALVI Net Sales		$55 – $75
INVEGA Franchise Royalties*		$45 – $50
Cost of Goods Sold		$215 – $225
R&D Expenses		$385 – $415
SG&A Expenses		$575 – $605
Amortization of Intangible Assets		~$35
Other Expense, Net		$5 – $10
Income Tax Benefit		($10) – ($15)
GAAP Net Loss		($180) – ($210)
GAAP Net Loss per Share+		($1.10) – ($1.29)
Non-GAAP Net Loss		($30) – $0
Non-GAAP Loss Per Share+		($0.18) – $0.00
Capital Expenditures		$35 – $40

*Reflects royalties related to sales of INVEGA SUSTENNA/INVEGA TRINZA/INVEGA HAFYERA in the U.S. through January 2022 and royalties related to sales of XEPLION/TREVICTA through May 2022.

+2022 per share expectations are calculated based on a weighted average basic share count of approximately 163.0 million shares outstanding and a weighted average diluted share count of approximately 166.5 million shares outstanding.

Mr. Brown continued, "Over the last several years, we have worked to position the business such that our topline performance will be fueled primarily by the growth of our proprietary products. We estimate that the early termination of the Janssen license agreement in the United States and the impact of its potential termination outside the United States would together reduce our total revenues by approximately $260 million in 2022. From an operational perspective, we have adapted our budget, recognizing that even if we are able to favorably resolve our situation with Janssen, that resolution could take time. Today we are updating our long-term profitability targets to reflect exclusion of worldwide royalties from the long-acting INVEGA products. In the event that the situation with Janssen resolves in a manner favorable to Alkermes, or Janssen does not terminate our license agreement in markets outside the U.S., we would be positioned to accelerate the achievement of these targets. The revised profitability targets that we are announcing today reflect feedback from many of our institutional shareholders, our commitment to continued expense management and our focus on driving long-term profitability."

Profitability Targets

The company today updated its long-term profitability targets to reflect the removal of all royalty revenues related to sales of the long-acting INVEGA products in the U.S. after January 2022 and outside the U.S. after May 2022. The company is not providing reconciliations of, or comparable GAAP measures for, the following updated non-GAAP profitability targets, as they are not determinable without unreasonable efforts.*

The company is committed to achieving:

• FY 2025 non-GAAP net income equal to 25% of the company's total revenues and EBITDAii margin of 20% of total revenues

• FY 2026 non-GAAP net income equal to 30% of the company's total revenues and EBITDA margin of 25% of total revenues

As a bridge to these long-term profitability targets, the company expects to achieve non-GAAP net income in the range of 15% to 20% of the company's total revenues in FY 2024.

https://finance.yahoo.com/news/alkermes-plc-reports-financial-results-120000646.html

Equillium Acquires Bioniz Therapeutics Significantly Expanding Immunomodulatory Pipeline

 Acquisition includes two first-in-class clinical-stage assets and proprietary product discovery platform

Creates a robust immunology pipeline with significant value-creating milestones, and provides a strong clinical and research team with complementary expertise in immuno-inflammatory diseases

Closing consideration of 5,699,492 shares of common stock of Equillium

Equillium to host a conference call and webcast today at 8:00 a.m. Eastern Time

Webcast and Conference Call

Management will host a conference call accompanied by a slide presentation to discuss the acquisition of Bioniz for analysts and institutional investors, at 8:00 am ET today, February 16, 2022. To access the call, please dial (888) 350-3846 or (646) 960-0251 and, if needed, provide confirmation number 8770084. A live webcast of the call will also be available on the company’s Investor Relations page at https://ir.equilliumbio.com/events-and-presentations. The webcast will be archived for 180 days.

https://finance.yahoo.com/news/equillium-acquires-bioniz-therapeutics-significantly-120000412.html

FDA Accepts Mirati New Drug Application for Non-Small Cell Lung Cancer Treatment

  Mirati Therapeutics, Inc. (Nasdaq: MRTX), a clinical-stage targeted oncology company today announced that the U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for adagrasib for the treatment of patients with non-small cell lung cancer (NSCLC) harboring the KRASG12C mutation who have received at least one prior systemic therapy. The Prescription Drug User Fee Action (PDUFA) date for adagrasib is December 14, 2022.

The adagrasib NDA is being reviewed by the FDA for Accelerated Approval (Subpart H), which allows for the approval of drugs that treat serious conditions, and that fill an unmet medical need based on a surrogate endpoint. In addition, the application is being reviewed under the FDA Real-Time Oncology Review (RTOR) pilot program, which aims to explore a more efficient review process that ensures safe and effective treatments are made available to patients as early as possible. Adagrasib has also achieved Breakthrough Therapy Designation in the U.S. as a potential treatment for patients with NSCLC harboring the KRASG12C mutation who have received at least one prior systemic therapy.

https://finance.yahoo.com/news/u-food-drug-administration-fda-211500083.html

BioNTech says it won't challenge vaccine copying in Africa

 CEO comments echo Moderna pledge in 2020

* Says assembly kit factory best bet for African self-reliance

BioNTech's co-founder and top executive said the vaccine maker has no plans to enforce its intellectual property rights should organisations in Africa strike out on their own to produce unauthorised versions of the company's shot.

"Our goal is not to keep others from using our technology. Our goal is rather to actively see to it that our technology is available on all continents as safely and as widely as possible," CEO Ugur Sahin told Reuters TV on Wednesday when asked whether he would pursue breaches of patents or patents pending in Africa.

The remarks come after the company, which developed the western world's most widely used COVID-19 shot with U.S. drugmaker Pfizer, mapped out a plan to enable African countries to produce its Comirnaty-branded shot under BioNTech's supervision.

Sahin said the proprietary offshore production venture, dubbed Biontainer, was superior to hands-off data sharing because of the many pitfalls in quality maintenance.

At an earlier news conference Sahin said that novel cancer therapies BioNTech is working on will in future be made available on the continent at affordable prices.

Sahin's pledge on property rights echoes a similar statement by Moderna, which in 2020 said it would not enforce patents related to COVID-19 vaccines during the pandemic.

Different efforts are afoot to ease Africa's reliance on vaccine imports amid heated debate over whether Western vaccine pioneers are doing enough to support that cause.

Afrigen Biologics of South Africa, working with the World Health Organization, has set out to produce a version of Moderna's COVID-19 shot, even though it has not managed to win the U.S. vaccine developer's assistance.

Separately, South African-American businessman Patrick Soon-Shiong opened a vaccine plant in Cape Town in January, intended to help his NantSA company make COVID-19 shots in future.

https://finance.yahoo.com/news/1-biontech-says-wont-challenge-133000825.html

Bristol Myers: Positive Topline Results from Phase 3 Evaluating Mavacamten in Obstructive Hypertrophic Cardiomyopathy

 Bristol Myers Squibb (NYSE: BMY) today announced that VALOR-HCM, the Phase 3 randomized, double-blind, placebo-controlled study evaluating mavacamten in adults with symptomatic obstructive hypertrophic cardiomyopathy (obstructive HCM) who are eligible for septal reduction therapy (SRT), met its primary endpoint at Week 16. The safety of mavacamten was consistent with previous studies.

"We are encouraged by the findings from this important study, which add to the growing body of clinical evidence that supports the promise of mavacamten for patients living with obstructive HCM," said Roland Chen, M.D., Senior Vice President, Cardiovascular Development at Bristol Myers Squibb. "We look forward to sharing the results from VALOR-HCM at the American College of Cardiology 71st Annual Scientific Session & Expo taking place in April."

The company plans to share these data with regulatory authorities. Bristol Myers Squibb thanks the patients and investigators participating in the VALOR-HCM clinical trial.

https://finance.yahoo.com/news/bristol-myers-squibb-announces-positive-115900894.html