Theravance Biopharma, Inc. Stories 2d Quarter 2023 Monetary Effects and Supplies Industry Replace

• Q2 2023 YUPELRI^® (revefenacin) internet gross sales of $55.0 million, known by means of Viatris, up 12% from Q2 2022¹
• Q2 2023 YUPELRI general retail TRx and new to product TRx once more reached all-time highs, up 26% and 53%, Y/Y, respectively²
• PIFR-2 enrollment nearing finishing touch; top-line knowledge in past due This fall 2023, with disclosure expected in January 2024
• Corporate expects to finish $325 million capital go back program by means of year-end, having returned $80.5 million by way of percentage repurchases throughout Q2 2023 and $263.8 million since inception via quarter finish

DUBLIN, Aug. 7, 2023 /PRNewswire/ — Theravance Biopharma, Inc. (“Theravance Biopharma” or the “Corporate”) (NASDAQ: TBPH) these days introduced monetary and operational effects for the second one quarter of 2023.

“We’re very inspired by means of our workforce’s efficiency in Q2, with YUPELRI reaching excellent enlargement in each the sanatorium and group settings over the prior 12 months,” mentioned Rick E Winningham, Leader Govt Officer.  “We’re excited to capitalize at the business alternative for YUPELRI, probably enhanced near-term by means of PIFR-2, and understand the numerous alternative for ampreloxetine to dramatically enhance the lives of MSA sufferers with symptomatic nOH.”

Quarterly Highlights

• YUPELRI^® (revefenacin) inhalation answer, the primary and best once-daily, nebulized bronchodilator authorised within the US for the upkeep remedy of sufferers with power obstructive pulmonary illness (COPD). YUPELRI completed $55.0 million Q2 2023 gross sales, expanding 12% year-over-year (Q2 2023 vs Q2 2022)¹.  YUPELRI’s percentage of the long-acting nebulized COPD marketplace once more reached all-time highs, with sanatorium percentage at 15.2% (vs. 11.6% in Q2 ’22) and group percentage at 29.0% (vs. 25.3% in Q2 ’22)³.

  Theravance expects to finish enrollment within the YUPELRI PIFR-2 learn about in a while, with top-line knowledge to be to be had past due within the fourth quarter of 2023.  The Corporate expects to reveal height line ends up in January 2024. PIFR-2 evaluates revefenacin delivered by way of jet nebulizer in comparison to tiotropium delivered by way of dry powder inhaler in serious to very serious COPD sufferers with suboptimal top inspiratory float price.

• Ampreloxetine, an investigational, once-daily norepinephrine reuptake inhibitor in building for the remedy of symptomatic neurogenic orthostatic hypotension (nOH) in sufferers with a couple of device atrophy (MSA). All through the second one quarter, Theravance persevered to concentrate on website activation and recruitment for the CYPRESS Section 3 learn about. The workforce submitted a medical trial utility for a couple of EU international locations in the course of the area’s centralized procedure, in addition to in the United Kingdom and different international locations around the globe; key approvals are anticipated within the coming months.  As well as, Theravance’s medical workforce submitted abstracts to be offered at scientific conferences throughout the second one part of the 12 months.

• Monetary Replace:

  $80.5 million of percentage buybacks finished in Q2 2023 and $263.8 million from program inception via June 30, 2023.  As of June 30, 2023, the Corporate had $61.2 million final in this system, which is predicted to be finished by means of the tip of 2023. The Corporate stays on course to reach non-GAAP profitability in H2 ’23, matter to YUPELRI’s higher internet gross sales enlargement⁴.

• TRELEGY ELLIPTA (first once-daily unmarried inhaler triple remedy for COPD and bronchial asthma) GSK posted 2nd quarter 2023 world internet gross sales of $760 million (up 29% from $591 million reported in the second one quarter of 2022).⁵ 12 months thus far, via the second one quarter, GSK has posted TRELEGY world internet gross sales of $1.3 billion. Theravance Biopharma is entitled to a milestone fee from Royalty Pharma of $50 million if TRELEGY world internet gross sales are equivalent to or exceed $2.9 billion⁶ in 2023, the primary of $250 million of possible milestones that may be completed between 2023 and 2026.

2d Quarter Monetary Effects  

• Analysis and Building (R&D) Bills: R&D bills for the second one quarter of 2023 had been $9.4 million, in comparison to $14.9 million in the similar duration in 2022. 2d quarter R&D bills incorporated general non-cash share-based reimbursement of $1.9 million.

• Promoting, Common and Administrative (SG&A) Bills: SG&A bills for the second one quarter of 2023 had been $19.3 million, in comparison to $16.2 million in the similar duration in 2022. 2d quarter SG&A bills incorporated general non-cash share-based reimbursement of $4.4 million.

• Inventory Based totally Repayment: Proportion-based reimbursement bills for the second one quarter of 2023 had been $6.3 million, in comparison to $9.7 million in the similar duration in 2022. Except restructuring-related bills, share-based reimbursement bills had been $6.3 million and $7.9 million for the second one quarter of 2023 and 2022, respectively. Proportion-based reimbursement bills consisted of $1.9 million for R&D and $4.4 million for SG&A in the second one quarter of 2023, in comparison to $2.9 million and $5.0 million, respectively, in the similar duration in 2022. The numerous relief in general share-based reimbursement bills was once basically pushed by means of our 2021 restructuring, which was once considerably finished in early 2022 and our 2023 strategic movements, which was once considerably finished by means of the tip of March 2023.

• Restructuring and Similar Bills: Restructuring and connected bills for the second one quarter of 2023 had been $1.2 million in comparison to $3.0 million in the similar duration in 2022. The restructuring bills in the second one quarter of 2023 had been categorized as non-cash bills and was once associated with the loss from the sale of lab apparatus that generated internet coins proceeds of $1.5 million. We don’t be expecting any further employee-related restructuring bills, together with share-based reimbursement bills, associated with the 2023 strategic movements.

• Internet Loss from Operations and Non-GAAP Internet Loss (from proceeding operations)⁴ : Internet loss from proceeding operations was once $15.6 million in the second one quarter of 2023 in comparison to $22.8 million in the similar duration in 2022, and non-GAAP internet loss from proceeding operations was once $7.4 million in the second one quarter of 2023 in comparison to $13.1 million in the similar duration in 2022. Non-GAAP internet loss from proceeding operations is composed of GAAP internet source of revenue (loss) from operations, except share-based reimbursement expense, non-cash passion expense, and source of revenue tax expense (receive advantages). See the segment titled “Non-GAAP Monetary Measures” for more info.

• Money Place: Money, coins equivalents and marketable securities totaled $167.5 million as of June 30, 2023.

2023 Monetary Steering

• Working Bills (except share-based reimbursement and one-time restructuring prices): The Corporate continues to be expecting complete 12 months 2023 R&D expense of $35 million to $45 million and SG&A expense of $45 million to $55 million.

• The Corporate reaffirms its expectation that it is going to generate non-GAAP benefit in 2H 2023, matter to YUPELRI’s higher internet gross sales enlargement.⁴

Convention Name and Are living Webcast As of late at 5:00 pm ET

Theravance Biopharma will dangle a convention name and reside webcast accompanied by means of slides these days at 5:00 pm ET / 2:00 pm PT / 10:00 pm IST. To take part within the reside name by means of phone, please sign up right here. The ones focused on paying attention to the convention name reside by way of the web would possibly achieve this by means of visiting Theravance Biopharma’s site at www.theravance.com, below the Buyers segment, Shows and Occasions.

A replay of the webcast might be to be had on Theravance Biopharma’s site for 30 days via September 6, 2023.

Concerning the PIFR-2 Learn about

This learn about is a randomized, double-blind, parallel-group learn about, evaluating enhancements in lung serve as in adults with serious to very serious COPD and suboptimal inspiratory float price following once-daily remedy over 12 weeks with both YUPELRI (revefenacin) inhalation answer delivered by way of usual jet nebulizer or SPIRIVA^® (tiotropium) delivered by way of a dry powder inhaler (Spiriva^® HandiHaler^®).

About Theravance Biopharma

Theravance Biopharma, Inc.’s focal point is to ship Drugs that Make a Distinction^® in other people’s lives. In pursuit of its function, Theravance Biopharma leverages many years of experience, which has resulted in the advance of FDA-approved YUPELRI^® (revefenacin) inhalation answer indicated for the upkeep remedy of sufferers with power obstructive pulmonary illness (COPD). Ampreloxetine, its late-stage investigational norepinephrine reuptake inhibitor in building for symptomatic neurogenic orthostatic hypotension, has the prospective to be a primary in school remedy efficient in treating a constellation of cardinal signs in a couple of device atrophy sufferers. The Corporate is dedicated to making/using shareholder price.

For more info, please talk over with www.theravance.com.

THERAVANCE BIOPHARMA^®, THERAVANCE^®, and the Go/Famous person brand are registered logos of the Theravance Biopharma organization of businesses (within the U.S. and likely different international locations).

YUPELRI^® is a registered trademark of Mylan Uniqueness L.P., a Viatris corporate. Emblems, business names or provider marks of different corporations showing in this press unlock are the valuables in their respective homeowners.

Ahead-Having a look Statements

This press unlock and the convention name will include positive “forward-looking” statements as that time period is outlined within the Non-public Securities Litigation Reform Act of 1995 relating to, amongst different issues, statements when it comes to targets, plans, targets, expectancies and long run occasions. Theravance Biopharma intends such forward-looking statements to be lined by means of the secure harbor provisions for forward-looking statements contained in Segment 21E of the Securities Trade Act of 1934, as amended, and the Non-public Securities Litigation Reform Act of 1995. Examples of such statements come with statements when it comes to: the Corporate’s repurchase of its extraordinary stocks by means of an open marketplace percentage repurchase program, the have an effect on of latest headcount discounts in reference to focusing investments in analysis, the Corporate’s governance insurance policies and plans, the Corporate’s expectancies relating to its allocation of sources and upkeep of expenditures, the Corporate’s targets, designs, methods, plans and targets, long run YUPELRI gross sales, the power to supply price to shareholders, the Corporate’s regulatory methods and timing of medical research, imaginable protection, efficacy or differentiation of our investigational remedy, and contingent bills because of the Corporate from the sale of the Corporate’s TRELEGY ELLIPTA royalty pursuits to Royalty Pharma. Those statements are in line with the present estimates and assumptions of the control of Theravance Biopharma as of the date of this press unlock and the convention name and are matter to dangers, uncertainties, adjustments in cases, assumptions and different components that can purpose the real result of Theravance Biopharma to be materially other from the ones mirrored within the forward-looking statements. Essential components that might purpose exact effects to vary materially from the ones indicated by means of such forward-looking statements come with, amongst others, dangers associated with: whether or not the milestone thresholds can also be completed, delays or difficulties in starting up, enrolling or finishing medical research, the prospective that effects from medical or non-clinical research point out the Corporate’s product applicants or product are unsafe, useless or no longer differentiated, dangers of selections from regulatory government which might be damaging to the Corporate, dependence on 3rd events to behavior medical research, delays or failure to reach and care for regulatory approvals for product applicants, dangers of participating with or depending on 3rd events to find, expand, manufacture and commercialize merchandise, and dangers related to organising and keeping up gross sales, advertising and marketing and distribution functions with suitable technical experience and supporting infrastructure, talent to retain key workforce, the have an effect on of the Corporate’s contemporary restructuring movements on its workers, companions and others, the power of the Corporate to offer protection to and to put into effect its highbrow belongings rights, volatility and fluctuations within the buying and selling worth and quantity of the Corporate’s stocks, and normal financial and marketplace stipulations. Different dangers affecting Theravance Biopharma are within the Corporate’s Shape 10-Q filed with the SEC on Would possibly 10, 2023, and different periodic reviews filed with the SEC. Along with the dangers described above and in Theravance Biopharma’s filings with the SEC, different unknown or unpredictable components additionally may have an effect on Theravance Biopharma’s effects. No forward-looking statements can also be assured, and exact effects would possibly vary materially from such statements. Given those uncertainties, you must no longer position undue reliance on those forward-looking statements. Theravance Biopharma assumes no legal responsibility to replace its forward-looking statements as a result of new data, long run occasions or another way, with the exception of as required by means of regulation.

Non-GAAP Monetary Measures

Theravance Biopharma supplies a non-GAAP profitability goal and a non-GAAP metric on this press unlock. Theravance Biopharma believes that the non-GAAP profitability goal and non-GAAP internet loss from operations supply significant data to lend a hand traders in assessing potentialities for long run efficiency and exact efficiency as they supply higher metrics for examining the efficiency of its industry by means of except pieces that might not be indicative of core running effects and the Corporate’s coins place. As a result of non-GAAP monetary goals and metrics, similar to non-GAAP profitability and non-GAAP internet loss from operations, aren’t standardized, it might not be imaginable to match those measures with different corporations’ non-GAAP goals or measures having the similar or a equivalent identify. Thus, Theravance Biopharma’s non-GAAP measures must be thought to be along with, no longer as an alternative choice to, or in isolation from, the Corporate’s exact GAAP effects and different goals.

Touch:
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650-808-4045

¹ In the USA, Viatris is main the commercialization of YUPELRI, and the Corporate co-promotes the product below a benefit and loss sharing association (65% to Viatris; 35% to the Corporate).
² Symphony Well being METYS Prescription Dashboard. Retail knowledge serves as a proxy for the entire group (Retail + DME).
³ Clinic LA-NEB Marketplace Proportion – IQVIA DDD via 6/30/2023. Neighborhood LA-NEB Marketplace Proportion contains Retail + DME / Med B FFS via Would possibly ’23.
⁴ Non-GAAP benefit (loss) is composed of GAAP internet source of revenue (loss) sooner than taxes much less share-based reimbursement expense and non-cash passion expense. See the segment titled “Non-GAAP Monetary Measures” for more info.
⁵ Supply: GSK-reported Internet Gross sales in USD.
⁶ The primary milestone fee of $50.0 million might be precipitated if Royalty Pharma receives $240.0 million or extra in royalty bills from GSK with appreciate to 2023 TRELEGY world internet gross sales, which we’d be expecting to happen within the tournament TRELEGY world internet gross sales achieve roughly $2.863 billion. Royalties payable from GSK to Royalty Pharma are upward tiering from 6.5% to ten%.

SOURCE Theravance Biopharma, Inc.