Verona Pharma Share Discussion Threads

[tradertrev] 07/1/2025 14:05

Q4 sales pre-announced this morning:
Jefferies thought street estimates for Q4 sales were $17m with "whisper numbers" a little over $20m. Pre-announced net sales reported as $36m. Completely knocked it out of the park!
Shares currently up 5% in the pre-market.

“2024 was another transformational year for Verona with the approval and US launch of Ohtuvayre (ensifentrine) for the maintenance treatment of chronic obstructive pulmonary disease (“COPD”),” said David Zaccardelli, Pharm. D., President and Chief Executive Officer. “We are very pleased to report the exceptionally strong start to the launch of Ohtuvayre continues with more than 3,500 unique healthcare professionals (“HCPs”) prescribing Ohtuvayre and over 16,000 prescriptions filled of which approximately one-third were patient refills in 2024. During these initial 20 weeks, key metrics showed month over month growth including number of unique prescribers, new patient prescriptions, refill prescriptions, and net sales while maintaining approximately two weeks of inventory at the specialty pharmacies. Specifically, filled prescriptions increased by over 35% each month in the fourth quarter and physicians continued to prescribe Ohtuvayre across a broad COPD population including those receiving background single, dual and triple therapy.

“We recorded net product sales of approximately $36 million in the fourth quarter and $42 million for full year 2024. While it is still early in the launch, feedback from HCPs and patients is consistently positive including robust refill rates, and increasing prescriber depth with over 150 HCPs prescribing Ohtuvayre to more than 20 patients in their practice. These trends reinforce our belief that Ohtuvayre’s bronchodilator and non-steroidal anti-inflammatory activity can re-define the COPD treatment paradigm. We are excited by the initial impact of Ohtuvayre and look forward to building on this momentum in 2025.”

[haroldthegreat] 02/1/2025 20:03

Waited a long time for this ! Was going to sell when it delisted from London but luckily decided against it . Looking forward to further increases before I die of old age .

[tradertrev] 02/1/2025 15:55

Short interest still 8.1% - ouch!

[tradertrev] 02/1/2025 15:31

Jefferies, who have a TP of $50, put out a note just before Christmas detailing feedback from pulmonologists they had surveyed about their prescribing experience with Ohtuvayre. Jefferies said this feedback suggested a peak US market share of 18% compared to their working assumpation of $1.5bn peak sales being less than 1.5% market share. Caveat to my considerable excitement about this is that the feedback sample is very small - only 8 doctors.
The note also mentions the company's plan to pre-announce Q4 sales in January. I've now had that from two sources.

[tradertrev] 02/12/2024 14:58

Interesting podcast interview of our CEO in connection with the upcoming SCRIP awards, where Ohtuvayre is up for best new drug of the year. He sounds quite excited (by his usual standards!)

[tradertrev] 04/11/2024 17:27

Shares currently up 10% at $38.5. Brokers are going to have to adjust their TPs.

[haroldthegreat] 04/11/2024 13:59

Verona Pharma plc
Mon, November 4, 2024 at 7:00 AM GMT 8 min read


In This Article:
VRNA
+3.09%
Ohtuvayre™ (ensifentrine) launch recorded Q3 net sales of $5.6 million and October net sales exceeded Q3

Through October more than 2,200 unique prescribers and more than 5,000 prescriptions filled across a broad COPD population

Pipeline expansion continues: Phase 2 programs enrolling

Conference call today at 9:00 a.m. ET / 2:00 p.m. GMT

LONDON and RALEIGH, N.C., Nov. 04, 2024 (GLOBE NEWSWIRE) -- Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”;), a biopharmaceutical company focused on respiratory diseases, announces its financial results for the third quarter ended September 30, 2024, and provides a corporate update.

“We are pleased to report an exceptionally strong start to the US launch of Ohtuvayre (ensifentrine) with healthcare professionals (HCPs) prescribing treatment across a broad range of chronic obstructive pulmonary disease (“COPD”) patients including background single, dual and nearly 50% on triple therapy,” said David Zaccardelli, Pharm. D., President and Chief Executive Officer. “While it is still very early in the launch, we are extremely encouraged from the initial patient and HCP reports about Ohtuvayre’s potential to improve COPD symptoms regardless of COPD severity. This broad utilization across all patient types is consistent with market research and supports our belief that Ohtuvayre’s bronchodilator and non-steroidal anti-inflammatory activity is a significant advancement for COPD patients and can re-define the treatment paradigm.

“In the third quarter, through the first seven weeks of launch, we recorded $5.6 million of net sales. We are excited by the continued acceleration as net sales for October exceeded the third quarter. More than 5,000 Ohtuvayre prescriptions were filled and more than 2,200 unique HCPs prescribed Ohtuvayre in just 12 weeks.

“Alongside our successful Ohtuvayre launch, in the third quarter we initiated two Phase 2 clinical trials: a dose-ranging trial with glycopyrrolate, a long-acting muscarinic antagonist (“LAMA”), supporting a nebulized fixed-dose combination program with ensifentrine for the maintenance treatment of COPD, and a trial assessing the efficacy and safety of nebulized ensifentrine in patients with non-cystic fibrosis bronchiectasis (“NCFBE”).”

Third Quarter and Recent Highlights

In August 2024, the Company launched Ohtuvayre for the maintenance treatment of COPD in the US.

During the third quarter of 2024, the Company began enrollment in two new clinical programs:

Phase 2 dose-ranging trial with glycopyrrolate, a LAMA, supporting a fixed-dose combination program for the maintenance treatment of COPD via a nebulizer.

Phase 2 trial to assess the efficacy and safety of nebulized ensifentrine in patients with NCFBE.

Following the end of the third quarter, the Company received notification from the Centers for Medicare & Medicaid Services that its permanent, product-specific J-code for Ohtuvayre, J7601, has been accepted and will be effective January 1, 2025.

The Company recently presented additional analyses of data from the Phase 3 ENHANCE trials with ensifentrine for the maintenance treatment of COPD at the European Respiratory Society International Congress 2024 and at CHEST Annual Meeting 2024 (“CHEST”). Approximately 1,500 HCPs visited Verona Pharma’s medical and commercial booths for Ohtuvayre at CHEST.

In September 2024, the Company’s development partner in Greater China, Nuance Pharma, completed enrollment in its pivotal Phase 3 clinical trial evaluating ensifentrine for the maintenance treatment of COPD in China. Results from the trial are expected in 2025.

Third Quarter 2024 Financial Results

Cash position: Cash and cash equivalents at September 30, 2024 were $336.0 million (December 31, 2023: $271.8 million). The Company believes cash and cash equivalents at September 30, 2024, along with product sales and funding expected to become available under the $650 million strategic financings completed in May 2024, will enable Verona Pharma to fund planned operating expenses and capital expenditure requirements through at least the end of 2026.

Product sales: Net sales were $5.6 million for the third quarter ended September 30, 2024 (Q3 2023: $0 million) related to product sales of Ohtuvayre. The Company received FDA approval on June 26, 2024 and the product was commercially available beginning in August 2024.

Cost of sales: Cost of sales was $0.5 million for the third quarter ended September 30, 2024 (Q3 2023: $0 million), which included Ohtuvayre manufacturing costs incurred after US approval, inventory overhead costs and sales-based royalties due to Ligand.

R&D Expenses: Research and development (“R&D̶1;) expenses were $10.6 million for the third quarter ended September 30, 2024 (Q3 2023: $3.0 million). This increase of $7.6 million was primarily due to an $7.8 million increase in clinical trial and other development costs as we initiated two Phase 2 trials in the quarter.

SG&A Expenses: Selling general and administrative expenses (“SG&AR21;) were $35.2 million for the third quarter ended September 30, 2024 (Q3 2023: $13.4 million). This increase of $21.8 million was driven primarily by a $9.7 million increase in people-related costs and $2.8 million in share-based compensation primarily related to our field sales team, which was hired in the lead up to the launch of Ohtuvayre. Additionally, marketing and other commercial related activities, including travel, increased by $7.5 million due to the launch. We also had an increase of $1.6 million related to professional and consulting fees, information technology costs and other support costs due to the continued build-out of our commercial organization.

Net loss: Net loss was $43.0 million for the third quarter ended September 30, 2024 (Q3 2023: $14.7 million).

[tradertrev] 04/11/2024 10:26

Happy enough with that Q3 report. Ohtuvayre sales have got off to a good start.

[tradertrev] 01/11/2024 09:37

Fingers crossed for good news on Monday

[haroldthegreat] 21/10/2024 11:56

This is worth a read.

[haroldthegreat] 21/10/2024 11:49

In the United States, nearly 16 million adults have chronic obstructive pulmonary disease (COPD), but many more people have it and don't know it:

[haroldthegreat] 21/10/2024 11:48

Ohtuvayre, a COPD maintenance treatment, costs $2,950 per month, or $35,400 per year:
This price is almost three times higher than the Institute for Clinical Economic Review's (ICER) recommended valuation range of $7,500 to $12,700 per year. ICER is a non-profit that evaluates drug prices based on their health benefits and risks.

I wonder what the co-pay is ?
When was the drug launched in USA ?

[tradertrev] 21/10/2024 11:04

Q3 results and presentation on 4th Nov. Should be the first proper read on the initial uptake of Ohtuvayre (Ensifentrine).
Hoping for some (early) fireworks!

[approach3] 18/10/2024 09:42

Hurrah ! bought £1000 of these in 2010 recommended by a fraud tipster.At one stage they were worth less than £100.I am at last in profit.Perserverence has paid off.

[tradertrev] 18/10/2024 07:07

Wells Fargo recently initiated with $50 TP. Another broker recently increased target. All very encouraging.

[timbo003] 14/8/2024 08:09

It's lookin' good tradertrev

Plenty more in the pipeline too 🙂

[tradertrev] 13/8/2024 20:41

Shares at the highest ever since Nasdaq listing. The number of subscribing physicians in the first few days since launch is being seen as very encouraging.

[tradertrev] 12/7/2024 10:53

US broker TPs seen at $34-38 although these are probably relatively short term (guessing about 6 months) before a single scrip has been written.

[haff1] 12/7/2024 10:26

Yes...but what will it be worth at the end of the day?

[tradertrev] 17/6/2024 18:51

FDA delayed decision on Sanofi's Dupixent for COPD by 3 months. This happened on 31 May since when Verona's shares have been rallying strongly.
Verona's Ensifentrine meanwhile has its PDUFA date in 9 days' time. The long, long wait could finally be ending!

[tradertrev] 02/2/2024 09:32

Short interest down to 12.09%

[tradertrev] 02/1/2024 08:47

This should be a very exciting year for the company

[haroldthegreat] 01/1/2024 22:50

thank you Tim for the share chart.

[tradertrev] 15/12/2023 14:54

Bear squeeze?

[tradertrev] 11/12/2023 12:47

Latest short interest gone up to 11.1% (!) according to Seeking Alpha. Will be interesting to see if this moves given yesterday's move up (and today pre-market looking perky again - last print up another 6% to $15.48