On January 10, 2022 Apollo Endosurgery, Inc. ("Apollo" or the "Company") (NASDAQ: APEN), a global leader in less invasive medical devices for gastrointestinal and bariatric procedures, reported preliminary unaudited revenue results for the fourth quarter and full year ended December 31, 2021 (Press release, Apollo Endosurgery, JAN 10, 2022, View Source [SID1234598557]).

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Preliminary, Unaudited 2021 Revenue

Preliminary, unaudited full year 2021 revenue increased approximately 50% compared to 2020. In addition, preliminary, unaudited fourth quarter 2021 revenue grew approximately 25% year-over year, despite the impact of the recent surge in COVID-19 cases, which pressured procedural volumes in several key geographies, both domestic and international.
"Our 2021 performance gives me great confidence in our ability to capitalize on momentum in our business. Even with the recent pandemic-related procedure volume variability that returned in the fourth quarter, we continue to see strong adoption of our products for gastrointestinal and weight loss procedures in markets around the world," said Chas McKhann, president and CEO. "2021 was a transformational year for Apollo. We have revitalized our organization and built a strong foundation to positively impact patient care and address enormous unmet clinical needs in gastrointestinal and weight loss applications."
Anticipated revenue growth for 2021 was led by the company’s endoscopic suturing (ESS) portfolio, which grew between 37% and 38% in the fourth quarter and between 55% and 56% for the full year compared to 2020, highlighting continued demand for Apollo’s OverStitch and X-Tack products across a range of patient indications. Anticipated intragastric balloon (IGB) revenue grew between 19% and 20% in the fourth quarter and between 49% and 50% for the full year compared to 2020, reflecting recovery in elective procedures for the ORBERA balloon from lower volumes experienced at the outset of the global COVID pandemic in 2020.
The Company expects to announce its fourth quarter and full-year 2021 financial and operating results and full year 2022 revenue guidance on February 22, 2022, after market close.
Financial Disclosure Advisory
The Company reports its financial results in accordance with U.S. generally accepted accounting principles. The expected financial results discussed in this press release are preliminary and represent the most current information available to the Company’s management, as financial closing procedures for the quarter and year ended December 31, 2021 are not yet complete. These estimates are not a comprehensive statement of the Company’s financial results for the quarter and year ended December 31, 2021, and actual results may differ materially from these estimates as a result of the completion of normal quarter-end accounting procedures and adjustments, including the execution of the Company’s internal control over financial reporting, the completion of the preparation and review of the Company’s financial statements for the year ended December 31, 2021 and the subsequent occurrence or identification of events prior to the formal issuance of such financial results. In addition, Moss Adams LLP, our independent registered public accounting firm, has not audited, reviewed, compiled or performed any procedures with respect to these preliminary financial results. Accordingly, Moss Adams LLP does not express an opinion or any other form of assurance with respect thereto.

On January 10, 2022 Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, reported its preliminary* fourth quarter and full year 2021 global net product revenues for ONPATTRO, GIVLAARI and OXLUMO and provided additional updates on the products’ commercial launches (Press release, Alnylam, JAN 10, 2022, View Source [SID1234598556]).

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2021 Preliminary Commercial and Financial Performance*

ONPATTRO (patisiran), a commercial-stage RNAi therapeutic targeting transthyretin (TTR) for the treatment of polyneuropathy in adult patients with hATTR amyloidosis.

Preliminary global net product revenues for the fourth quarter and full year 2021 were approximately $139 million and $475 million, respectively, representing quarterly and annual growth of 15% and 55% compared to Q3 2021 and full year 2020, respectively.

As of year-end 2021, over 2,050 patients worldwide were receiving commercial ONPATTRO.

GIVLAARI (givosiran), a commercial-stage RNAi therapeutic for the treatment of adults with acute hepatic porphyria (AHP).

Preliminary global net product revenues for the fourth quarter and full year 2021 were approximately $41 million and $128 million, respectively, representing quarterly and annual growth of 28% and 132% compared to Q3 2021 and full year 2020, respectively.

As of year-end 2021, over 350 patients worldwide were receiving commercial GIVLAARI.

OXLUMO (lumasiran), a commercial-stage RNAi therapeutic for the treatment of primary hyperoxaluria type 1 to lower urinary oxalate levels in pediatric and adult patients.

Preliminary global net product revenues for the fourth quarter and full year 2021 were approximately $19 million and $60 million, respectively, representing quarterly growth of 29% compared to Q3 2021.

As of year-end 2021, over 140 patients worldwide were receiving commercial OXLUMO.

Finally, the Company today reported that it expects its full year 2021 non-GAAP operating loss to be substantially improved relative to the prior year, as the Company continues to transition toward a self-sustainable financial profile.

Further, at December 31, 2021, Alnylam had preliminary cash, cash equivalents, and marketable securities of approximately $2.4 billion, as compared to $1.9 billion at December 31, 2020.

"We are pleased to have closed out 2021 on a very strong note with continued execution across our commercial portfolio, delivering top-line revenue at the upper end of our guidance range. These preliminary results reflect the dedication of our teams to deliver these important medicines to patients in need around the world, despite the variable dynamics posed by the ongoing pandemic. We’re also excited to have ended the year with Leqvio, partnered with Novartis, becoming the fourth RNAi therapeutic approved in the U.S., and the first indicated to treat a major risk factor for a highly prevalent disease," said Yvonne Greenstreet, MBChB, Chief Executive Officer of Alnylam. "Furthermore, as we reflect upon the one year anniversary of the announcement of our Alnylam P5x25 strategy, we believe we are well on our way to achieving or potentially exceeding these ambitious goals, positioning Alnylam as a top-tier, global, multi-product commercial company with a broad pipeline and organic platform poised to deliver sustainable innovation well into the future, a profile rarely seen in our industry."

Alnylam management will discuss these preliminary selected financial results and commercial updates during a webcast presentation at the 40th Annual J.P. Morgan Healthcare Conference, being held virtually, tomorrow, Monday, January 10, 2022 at 9:45 am ET.

About RNAi Therapeutics

RNAi (RNA interference) is a natural cellular process of gene silencing that represents one of the most promising and rapidly advancing frontiers in biology and drug development today. Its discovery has been heralded as "a major scientific breakthrough that happens once every decade or so," and was recognized with the award of the 2006 Nobel Prize for Physiology or Medicine. By harnessing the natural biological process of RNAi occurring in our cells, a new class of medicines known as RNAi therapeutics is now a reality. Small interfering RNA (siRNA), the molecules that mediate RNAi and comprise Alnylam’s RNAi therapeutic platform, function upstream of today’s medicines by potently silencing messenger RNA (mRNA) – the genetic precursors – that encode for disease-causing or disease pathway proteins, thus preventing them from being made. This is a revolutionary approach with the potential to transform the care of patients with genetic and other diseases.

On January 10, 2022 Medivir AB (Nasdaq Stockholm: MVIR) reported that the company will present at the virtual meeting H.C. Wainwright BioConnect Virtual Conference, January 10-13 (Press release, Medivir, JAN 10, 2022, View Source [SID1234598554]).

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The presentation will be available via Medivirs website; www.medivir.com.

More information about the event is available at the organizer’s website: View Source

On January 10, 2022 IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported corporate and portfolio updates in connection with its participation in the J.P. Morgan Annual Healthcare Conference (Press release, Ideaya Biosciences, JAN 10, 2022, View Source [SID1234598553]).

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Yujiro Hata, President and Chief Executive Officer of IDEAYA, will present at the J.P. Morgan 40th Annual Healthcare Conference on Tuesday, January 11, 2022 at 9:45 am ET. The presentation will be followed by an analyst-hosted Q&A session with Anupam Rama, Managing Director, US SMID Biotechnology Equity Research, J.P. Morgan.

Key corporate and portfolio updates, which the company is planning to discuss in its J.P. Morgan presentation, include:

Strong balance sheet of ~$386 million cash, cash equivalents and marketable securities as of September 30, 2021, is anticipated to fund planned operations into 2025
Completed enrollment into dose escalation Cohort 5 of the Phase 1 clinical trial evaluating IDE397, a potential best-in-class MAT2A inhibitor, in patients with MTAP-deletion tumors; Cohort 5 is an estimated clinically active dose based on the preclinical PDx data
Targeting IDE397 protocol amendment to FDA in Q1 2022 to enable monotherapy cohort expansions, and combination initiation in first half of 2022
Targeting delivery of GSK option data package for IDE397 in first half of 2022 to trigger a review period for potential $50 million opt-in decision
Demonstrated preclinical in vivo efficacy of IDE397 plus standard-of-care combination agents, including with paclitaxel in head and neck cancer
Targeting PARG inhibitor IND submission in fourth quarter of 2022, subject to satisfactory completion of ongoing preclinical and IND-enabling studies
Targeting initiation of IND-enabling studies for Pol Theta Helicase program in first half of 2022; potential $20 million aggregate GSK milestone payments for preclinical to early Phase 1
Observed Werner Helicase inhibitor in vivo efficacy with approximately 100% tumor growth inhibition; targeting Werner Helicase development candidate nomination in 2023
Enrolling into Phase 2 clinical trial evaluating darovasertib and crizotinib clinical combination in Metastatic Uveal Melanoma; targeting update of clinical data and regulatory guidance on potential registrational clinical trial in first half 2022
Evaluating potential indication expansion for darovasertib into additional MET-driven tumors, such as hepatocellular carcinoma (HCC) and non-small cell lung cancer (NSCLC)
A live audio webcast of IDEAYA’s J.P. Morgan presentation will be available, as permitted by conference host, at the "Investors/News and Events/Investor Calendar" section of the IDEAYA website at View Source A replay of available webcasts will be accessible for 30 days following the live event.

On January 10, 2022 Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, reported a corporate update and highlighted key 2022 milestones in anticipation of its presentation at the 40th Annual J.P. Morgan Healthcare Conference being held virtually January 10 – 13, 2022 (Press release, Nuvation Bio, JAN 10, 2022, View Source [SID1234598552]).

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"We are proud of the significant strides Nuvation Bio made in 2021, including the ongoing progress of our Phase 1/2 study of NUV-422 in patients with high-grade glioma, hormone receptor-positive metastatic breast cancer, and metastatic castration-resistant prostate cancer. Since the trial initiated, the FDA has cleared three INDs for NUV-422 and granted it Fast Track Designation for the treatment of high-grade glioma, demonstrating the therapy’s broad potential to address the significant unmet needs of patients with a variety of cancer types," said David Hung, M.D., founder, president, and chief executive officer of Nuvation Bio. "We look forward to building upon this momentum in 2022 with advancements across our deep pipeline of treatments for the most difficult-to-treat cancers."

In 2022, Nuvation Bio seeks to achieve the following milestones across its broad pipeline of potential product candidates:

NUV-422, CDK 2/4/6: High-grade glioma, aBC, mCRPC

Identify a recommended Phase 2 dose and initiate Phase 2 monotherapy dose expansion cohorts for NUV-422 in glioblastoma multiforme, advanced breast cancer (aBC), and metastatic castration-resistant prostate cancer (mCRPC)
Initiate Phase 1b combination studies for NUV-422 in aBC and mCRPC
Present safety data from NUV-422 Phase 1 dose escalation study
NUV-868, BD2 Selective BETi: Solid tumors

Receive clearance from U.S. Food and Drug Administration (FDA) on an Investigational New Drug (IND) application for NUV-868 and initiate a Phase 1 study in patients with advanced solid tumors
NUV-569, Wee1i: Solid tumors

File an IND for NUV-569 with the FDA for the treatment of patients with solid tumors
A2A and DDC Programs

Select clinical candidates
Presentation at J.P. Morgan Healthcare Conference

David Hung, M.D., founder, president, and chief executive officer, will present virtually at the 40th Annual J.P. Morgan Healthcare Conference on Tuesday, January 11, 2022 at 7:30 a.m. ET. The presentation will be webcast live and can be accessed under "Events & Presentations" in the "Investors" section of Nuvation Bio’s website at www.nuvationbio.com.