Veracyte ups 2022 forecast

 The company is raising full-year 2022 total revenue expectations to $288 million to $293 million, representing year-over-year growth of 31% to 33%, assuming currency rates as of November 2, 2022. This represents an improved outlook compared to our prior guidance of $272 million to $280 million.

Conference Call and Webcast Details

Veracyte will host a conference call and webcast today at 4:30 p.m. Eastern Time to discuss the company's financial results and provide a general business update. The conference call will be webcast live from the company’s website and will be available via the following link: https://edge.media-server.com/mmc/p/iigzqcix. The webcast should be accessed 10 minutes prior to the conference call start time. A replay of the webcast will be available for one year following the conclusion of the live broadcast and will be accessible on the company’s website at https://investor.veracyte.com/events-presentations.

The conference call dial-in can be accessed by registering at the following link: https://register.vevent.com/register/BIdd8a25033ce74acb8bf03d2ed76733f0

https://finance.yahoo.com/news/veracyte-announces-third-quarter-2022-200500651.html

Kura: Transactions with Bristol Myers Squibb, Hercules Capital, Providing up to $150 M

  $25 million equity investment from Bristol Myers Squibb at $18.25 per share –

– Term loan facility from Hercules Capital provides up to $125 million –

– Proceeds extend Kura’s cash runway into 2026, if term loan is fully drawn –

https://finance.yahoo.com/news/kura-oncology-announces-financing-transactions-110000421.html

Neurocrine: Additional Phase 3 Data for Huntington Disease

 Neurocrine Biosciences, Inc. (NASDAQ: NBIX), a leading neuroscience-focused biopharmaceutical company, today reported additional results from the Phase 3 KINECT-HD study investigating valbenazine for the treatment of chorea associated with Huntington Disease (HD). In December 2021, Neurocrine previously reported that once-daily administration of valbenazine was well tolerated with a statistically significant improvement in chorea associated with HD compared with placebo, along with substantial clinician- and patient-rated global improvement. The additional data includes an exploratory analysis of valbenazine effects over time, dosages at the end of the study, and detailed information about treatment-emergent adverse events (TEAEs) and safety parameters, such as electrocardiogram (ECG) and laboratory tests. These data (Poster #2: Valbenazine for the Treatment of Chorea Associated with Huntington Disease: Results from a Phase 3 Trial) will be shared at the 29^th annual meeting of the Huntington Study Group in Tampa, Florida on November 3–5.

https://www.biospace.com/article/releases/neurocrine-biosciences-presents-additional-phase-3-data-for-kinect-hd-study-evaluating-valbenazine-for-chorea-associated-with-huntington-disease-at-hsg-2022/

Aurinia cuts revenue guidance

 Net revenue of $55.8 million for Q3 2022; including $30.0 million milestone from Otsuka related to European Approval of LUPKYNIS® (voclosporin)

Adjusts net product revenue guidance to $100-105 million from sales of LUPKYNIS for 2022

Issues preliminary net product revenue guidance for 2023 in the range of $120-140 million from sales of LUPKYNIS

Approximately $400 million of cash, cash equivalents, restricted cash and investments as of October 31, 2022

Conference call to be hosted today at 8:30 a.m. ET

Aurinia will host a conference call and webcast to discuss the quarter ended September 30, 2022 financial results today, Thursday, November 3, 2022 at 8:30 a.m. ET. The audio webcast can be accessed under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. In order to participate in the conference call, please dial +1 (877) 407-9170 (Toll-free U.S. & Canada). An audio webcast can be accessed under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia’s website.

https://finance.yahoo.com/news/aurinia-reports-third-quarter-nine-100000805.html

Amryt reaffirms guidance

 8.2% YoY revenue growth in Q3 to $61.1M - 12.5% on a constant currency basis

11th consecutive quarter of positive EBITDA generation; $12.5M in Q3 2022

Operating cash flows of $14.3M for Q3 2022

Cash of $83.4M at September 30, 2022

Mycapssa® revenues increased 26.9% QoQ to $5.7M and 292.8% YoY

CHMP positive opinion for Mycapssa® for the treatment of acromegaly in the EU

Pathway agreed with the FDA to initiate a Phase 3 study for NET - expected in Q1 2023

Filsuvez® European launch progressing well

Significant metreleptin LATAM $8.3M tender won - revenue expected to be recognized in Q4

Reaffirming FY 2022 revenue guidance to $260M - $270M, representing 17-21% YoY growth

Conference call and webcast today at 0830 ET / 1230 GMT

Amryt will host a conference call and webcast for analysts and investors today at 0830 ET/1230 GMT.

Webcast Player URL: https://edge.media-server.com/mmc/p/6nxxorrj

Telephone Dial in details:

Standard International Number	+ 39 (0) 02 802 0911
United States	+1 718 705 8796
United Kingdom	+44 (0) 1212 818004
Ireland	+353 (1) 526 9444

A playback facility will be available from November 3, 2022 - November 10, 2022. Access details for the playback facility are as follows: Dial +39 02 802 0987 then press 700723# and 723#.

https://finance.yahoo.com/news/amryt-reports-q3-2022-financial-110000743.html

Orthofix cash update, outlook cut

 Liquidity

As of September 30, 2022, cash totaled $51.7 million, compared to $87.8 million as of December 31, 2021. As of September 30, 2022, the Company had no borrowings under its five year $300 million secured revolving credit facility. For the first nine months of 2022, cash flow from operations decreased $20.6 million to $(13.9) million, while free cash flow decreased $25.1 million to $(31.1) million.

Business Outlook

As of the date hereof, the Company expects the following net sales results for the year ended December 31, 2022. These expectations are based on the current foreign currency exchange rates and do not include any additional exchange rate changes that may occur this year.

		Current 2022 Outlook		Previous 2022 Outlook
(Unaudited, U.S. Dollars, in millions, except per share data)		Range		Range
Full year net sales		$457 - $463		$455 - $465
Full year net sales growth rates – reported		(2%) - 0%		(2%) - 0%
Full year net sales growth rates – constant currency		1% - 2%		0% - 2%
Full year adjusted EBITDA		$52 - $54		$53 - $57
Full year adjusted EBITDA as percentage of net sales 1		12%		12%
Full year adjusted EPS		$0.40-$0.50		$0.45-$0.55
1 Calculated using the midpoint of estimated full year net sales

The Company is not able to provide expectations of GAAP operating income or GAAP EPS, the closest comparable U.S. GAAP measures to Adjusted EBITDA and Adjusted EPS, respectively (each of which are non-GAAP measures), on a forward-looking basis because the Company is unable to predict without unreasonable efforts the ultimate outcome of matters (including legal proceedings, acquisition-related expenses, accounting fair value adjustments, and other such items) that will determine the quantitative amount of the items excluded from the applicable non-GAAP measure, which items are further described in the reconciliation tables and related descriptions below. These items are uncertain, depend on various factors, and could be material to the Company’s results computed in accordance with U.S. GAAP.

Conference Call

Orthofix will host a conference call today at 8:30 AM Eastern time to discuss the Company's financial results for the third quarter of 2022. Interested parties may access the conference call by dialing (888) 330-2508 in the U.S. and Canada, and (240) 789-2735 in all other locations, and referencing the access code 9556380. A replay of the call will be available for three weeks by dialing (800) 770-2030 in the U.S. and Canada, and (647) 362-9199 in all other locations, and entering the access code 9556380. A webcast of the conference call may be accessed at ir.Orthofix.com.

https://finance.yahoo.com/news/orthofix-reports-third-quarter-2022-110000032.html

Moderna cuts COVID vaccine sales forecast on supply woes, shares tumble

 Moderna Inc cut its annual sales forecast for COVID-19 vaccine on Thursday, citing short-term supply constraints that would push some deliveries to next year, sending its shares down nearly 11% before the bell.

It now expects vaccine sales of $18 billion to $19 billion this year compared to a prior forecast of $21 billion due to delays at its contract manufacturing partner.

Demand for original coronavirus vaccines too has taken a hit in international markets as countries complete primary vaccine campaigns, while the roll out of updated Omicron-tailored boosters has been slow in the United States and Europe.

Some U.S. pharmacies in September had reported that government supply of Moderna's updated shot remains limited, causing appointments for the product to vary across the country.

Moderna's weak forecast comes just two days after rival Pfizer Inc's quarterly sales of its COVID-19 vaccine exceeded market expectations and the drugmaker raised the full-year sales view for its shots.

Jefferies analyst Michael Yee said Wall Street's expectations for the shot were too high and Moderna's forecast was "a stretch".

Its sales of $3.36 billion in the third quarter missed Wall Street estimates of $3.53 billion. The company said the lower sales was due to the timing of market authorization for bivalent booster shots and the related manufacturing ramp-up.

It also reported a $333 million charge on vaccines that had expired or were about to expire before being used and $209 million in expenses for unutilized manufacturing capacity.

Moderna expects $4.5 billion to $5.5 billion in sales from signed contracts for its COVID-19 shots in 2023.

https://finance.yahoo.com/news/moderna-shares-tumble-cutting-sales-110905985.html