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Theravance Biopharma, Inc. Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Business Update

On February 23, 2022 Theravance Biopharma, Inc. ("Theravance Biopharma" or the "Company") (NASDAQ: TBPH) reported financial results for the fourth quarter and full year ended December 31, 2021 (Press release, Theravance, FEB 23, 2022, View Source [SID1234608916]).

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"While COVID continues to impact communities around the country and health systems are strained, YUPELRI saw the highest quarter of net sales since its launch," said Rick E Winningham, Chief Executive Officer. "I am proud of our team and their ability to find a way to service the COPD community during this challenging time. YUPELRI once a day dosing is proving increasingly important in helping over-burdened healthcare professionals provide relief to their COPD patients. In addition, GSK’s TRELEGY sales reached their highest levels since launch driven by growth in the asthma indication."

"Strong performance by YUPELRI in Q4 and into 2022 will enable us to invest in our inhaled JAK inhibitor respiratory pipeline," continued Winningham. "Through an active business development program, we will continue to unlock value from our non-core asset portfolio throughout 2022. We remain on target to become sustainably cash-flow positive beginning the second half of this year."

Year-end Highlights

YUPELRI (revefenacin) inhalation solution, the first and only once-daily, nebulized bronchodilator approved in the US for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), continued to increase market share and achieved year-over-year net sales growth of 13%; its share of the long-acting nebulized COPD market increased to 23.2% through October 2021 (up from 18.2% in October 2020).
On January 10, 2022, the Company announced the enrollment of the first patient in a Phase 4 study of YUPELRI (read more about the announcement here).
Economic Interest

TRELEGY (first once-daily single inhaler triple therapy for COPD and asthma), in which the Company holds an economic interest, posted fourth quarter 2021 global net sales of $479 million (up from $315 million, in fourth quarter of 2020) achieving quarterly year-over-year sales growth of 52%, and full year 2021 global net sales of $1,674 million (up from $1,058 million, in 2020), achieving year-over-year sales growth of 58%; Theravance Biopharma is entitled to tiered payments equal to approximately 5.5% to 8.5% of TRELEGY global net sales.3
Fourth Quarter and Full Year Financial Results

Revenue: Total revenue for the fourth quarter of 2021 was $14.9 million, comprised of non-cash collaboration revenue of $2.8 million primarily attributed to our global collaboration with Janssen and $12.1 million in Viatris collaboration revenue. Total revenue for the fourth quarter represents a $3.8 million decrease over the same period in 2020. Full year 2021 revenue was $55.3 million, comprised of non-cash collaboration revenue of $11.5 million primarily attributed to our global collaboration with Janssen and $43.8 million in Viatris collaboration revenue.
YUPELRI: The Viatris collaboration revenue of $12.1 million for the fourth quarter represents amounts receivable from Viatris and is comprised of the Company’s 35% share of net sales of YUPELRI as well as its proportionate amount of the total shared costs incurred by the two companies. The non-shared YUPELRI costs incurred by Theravance Biopharma are recorded within operating expenses. While Viatris records the total net sales of YUPELRI within its financial statements, our implied 35% share of net sales of YUPELRI for the fourth quarter of 2021 was $15.3 million.
Research and Development (R&D) Expenses: R&D expenses for the fourth quarter of 2021 were $31.2 million, compared to $65.2 million in the same period in 2020. Fourth quarter R&D expenses included total non-cash share-based compensation of $3.4 million. In terms of Financial Guidance, full-year 2021 R&D expenses excluding non-cash share-based compensation and one-time restructuring costs were $168.0 million vs. Guidance of $170 million to $180 million.
Selling, General and Administrative (SG&A) Expenses: SG&A expenses for the fourth quarter of 2021 were $21.5 million, compared to $30.1 million in the same period in 2020. Fourth quarter SG&A expenses included total non-cash share-based compensation of $5.1 million. In terms of Financial Guidance, full-year 2021 SG&A expenses excluding non-cash share-based compensation and one-time restructuring costs were $71.2 million vs. Guidance of $65 million to $75 million.
Restructuring and Related Expenses: Restructuring expenses for the fourth quarter of 2021 were $18.4 million and primarily comprised of severance costs, termination-related benefits, one-time retention costs, and share-based compensation expense. Full year 2021 restructuring and related expenses were $20.1 million. Cash restructuring expenses were $9.8 million for the fourth quarter of 2021 and $11.5 million for full-year 2021; non-cash restructuring expenses were $8.6 million for the fourth quarter of 2021 and for the full-year 2021.
Operating Loss: Operating loss for the fourth quarter of 2021 was $56.2 million compared to $76.5 million in the same period of 2020. Full year 2021 operating loss was $257.8 million, or $195.7 million excluding share-based compensation expense compared to $297.8 million, or $234.8 million excluding share-based compensation expense in 2020.
Cash Position: Cash, cash equivalents and marketable securities totaled $173.5 million as of December 31, 2021.
2022 Financial Guidance

Operating Expenses (excluding share-based compensation and one-time restructuring costs): The Company expects full year 2022 R&D expense of $45 million to $55 million and SG&A expense of $35 million to $45 million.
The Company expects to be sustainably cash-flow positive beginning 2H 2022.
Conference Call and Live Webcast Today at 5:00 pm ET

Theravance Biopharma will hold a conference call and live webcast accompanied by slides today at 5:00 pm ET / 2:00 pm PT / 10:00 pm GMT. To participate in the live call by telephone, please dial (855) 296-9648 from the US or (920) 663-6266 for international callers, using the confirmation code 7456139. Those interested in listening to the conference call live via the internet may do so by visiting Theravance Biopharma’s website at www.theravance.com, under the Investors section, Presentations and Events.

A replay of the conference call will be available on Theravance Biopharma’s website for 30 days through March 25, 2022. An audio replay will also be available through 8:00 pm ET on March 2, 2022 by dialing (855) 859-2056 from the US, or (404) 537-3406 for international callers, and then entering confirmation code 7456139.

Innovent Announces First Patient Dosed with CD73 Antibody in Phase 1a/1b Clinical Trial for Advanced Solid Tumor

On February 23, 2022 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, reported that the first patient has been successfully dosed in the phase 1, first-in-human clinical trial of its proprietary CD73 antibody (development code: IBI325) in patients with advanced solid tumor (Press release, Innovent Biologics, FEB 23, 2022, View Source [SID1234608915]).

The open-label, dose escalation phase 1a/1b study (NCT05119998) will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of IBI325 as a single agent and in combination with sintilimab in patients with advanced solid tumors. The recommended dose for further clinical studies will also be determined.

CD73 is an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine. Adenosine binds adenosine A2A andA2B receptors on immune cells and inhibits immune responses directed against tumors. IBI325, as a differentiated, humanized antibody against CD73, is expected to relief the immunosuppressive tumor micro-environment and to work in combination with other cancer therapies such as PD-1 or PD-L1 antibodies. A complete inhibition to CD73 both soluble and on cell surface has been well demonstrated in preclinical studies. And the anti-tumor activities of IBI325 were observed in various tumor models.

Professor Jinming Yu, member of the Chinese Academy of Engineering and president of Shandong Cancer Hospital & Institute, stated, "CD73 is one of the most important targets in the adenosine pathway. Preclinical studies and preliminary clinical data from drugs in the same class has demonstrated the modulation effect of anti-CD73 in immune microenvironment. This new clinical trial will further evaluate the efficacy and safety profile of IBI325 alone and in combination with anti-PD-1 antibody and other immune checkpoint inhibitors in advanced tumors."

"Our preclinical data suggested that IBI325 could completely inhibit the activity of CD73 molecule with no ‘hook effect’ compared with the other candidates in the same class. An outstanding synergistic effect of combination with IBI325 and sintilimab was also demonstrated," said Dr. Zhou hui, senior VP of Innovent, "IBI325 has the potential to become the best-in-class molecule. The new combination therapy of IBI325 and sintilimab would potentially address the existing unmet medical needs left by current immunotherapies. We are excited that IBI325 has come to the clinical development stage, and are committed to develop new safe and efficacious treatment option for patients with advanced tumor."

About IBI325

IBI325 is a differentiated, humanized antibody against CD73, an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine. Adenosine binds adenosine A2A andA2B receptors on immune cells and inhibits immune responses directed against tumors. IBI325 is expected to relief the immunosuppressive tumor micro-environment and to work in combination with other cancer therapies such as PD-1 or PD-L1 antibodies. A complete inhibition to CD73 both soluble and on cell surface has been well demonstrated in preclinical studies. And the anti-tumor activities of IBI325 were observed in various tumor models.

Personalis to Present at the Cowen 42nd Annual Health Care Conference

On February 23, 2022 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported that its management team will present at the Cowen 42nd Annual Health Care Conference on Monday, March 7, 2022 at 2:10 p.m. Eastern Time (Press release, Personalis, FEB 23, 2022, View Source [SID1234608914]).

Quanterix Corporation to Release Fourth Quarter and Full Year 2021 Financial Results on March 1, 2022

On February 23, 2022 Quanterix Corporation (NASDAQ: QTRX), a company digitizing biomarker analysis with the goal of advancing the science of precision health, reported that it will release its financial results for fourth quarter 2021 before the start of trading on Tuesday, March 1, 2022 (Press release, Quanterix, FEB 23, 2022, View Source [SID1234608913]). Company management will host a conference call at 8:30 a.m. EST to discuss Quanterix’ financial results and provide a business update. The call will be hosted by Kevin Hrusovsky, Chairman and Chief Executive Officer, Quanterix.

Individuals interested in listening to the conference call may do so by dialing (833) 686-9351 for domestic callers, or (612) 979-9890 for international callers. Please reference the following Conference ID: 5230769. A live webcast will also be available at: View Source You may also access the live webcast by visiting the News & Events page within the Investors section of the Quanterix website at www.quanterix.com. The webcast will be available on the Company’s website for one year following completion of the call.

Alvotech and Fuji Pharma Expand Partnership for Additional Biosimilar Candidate in Japan

On February 23, 2022 Alvotech Holdings S.A. ("Alvotech"), a global biopharmaceutical company focused solely on the development and manufacture of biosimilar medicines for patients worldwide, and Japanese pharmaceutical company Fuji Pharma ("Fuji," Tokyo Stock Exchange: 4554) reported that they have agreed to add to their strategic partnership for the development and commercialization of biosimilar medicines in Japan (Press release, Alvotech, FEB 23, 2022, View Source [SID1234608912]).

Under terms of the agreement, Fuji will be granted exclusive commercial rights to an undisclosed biosimilar currently in early phase development. Alvotech will receive an upfront payment and be eligible for subsequent milestone payments tied to development progression, as well as a share of the in-market sales. The new agreement adds another biosimilar candidate to the partnership between Alvotech and Fuji, first announced in 2018, bringing the total number of proposed biosimilar products that the companies are partnering on to six. The Japanese market ranks third in overall pharmaceutical spending globally (source: IQVIA Institute).

"Fuji has a been a pioneer in biosimilars in the Japanese market," said Takayuki Iwai, Fuji’s President & CEO. "This expansion in our partnership with Alvotech demonstrates our commitment to patients and our focus on healthcare sustainability."

"A global approach to biosimilars is fundamental to our story," said Robert Wessman, Founder and Chairman of Alvotech. "We believe the dynamics in the Japanese market will favor biosimilars in the long-term as the health care system balances cost and patient access."

On December 7, 2021, Alvotech and Oaktree Acquisition Corp. II (NYSE: OACB.U, OACB, OACB WS) ("OACB"), 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."