Gilead ups forecasts as new HIV drug boosts sales

Gilead has become the latest pharma company to raise its full year sales forecasts following stronger than expected Q2 results.

AstraZeneca and Sanofi have already upped their forecasts for this year following their Q2 results, and the US pharma is also on the front foot following higher sales of HIV treatments.

Gilead said it now expects 2019 sales of $21.6 billion to rise to $22.1 billion in 2019, up from its previous forecast of $21.3 billion to $21.8 billion.

Sales of HIV drugs accounted for 71% of total sales and rose to $4.04 billion from $3.67 billion last year.

This was driven by Biktarvy, a three-drug cocktail in a single pill that keeps HIV, designed to be more tolerable and convenient than its older combinations typically based around the “backbone” of Truvada plus another pill.

Biktarvy was only approved in the US in February last year, but is already a blockbuster with sales of almost $1.2 billion.

Hepatitis C drug sales continued their decline, caused by tough competition in a shrinking market where many patients have been cured over the last few years, thanks to drugs from Gilead and its competitors including AbbVie.

Sales fell to $842 million from $1 billion, but this was still better than the $714 million predicted by analysts.

Total revenue was up slightly to $5.69 billion, from $5.65 billion, ahead of analysts’ estimates of $5.53 billion. Net income was almost $1.9 billion, up 3.5% from last year’s Q2.

Gilead’s CAR-T cancer cell therapy Yescarta is also gathering momentum, with sales of $120 million in Q2, compared with $68 million in last year’s Q2.

The results come as new CEO Daniel O’Day is making his mark on the business by taking it in new directions.

O’Day has already made several changes to the company’s senior management team, last month poaching Christi Shaw from Eli Lilly to run its cancer immunotherapy unit, Kite.

Gilead has also invested $5.1 billion in the Belgian biotech Galapagos to develop inflammatory disease and rheumatoid arthritis drugs.

Gilead ups forecasts as new HIV drug boosts sales

Alexandria Real Estate Equities Plans Another Boston Life Sciences Lab Facility

Alexandria Real Estate Equities is planning another life sciences development in Boston. The firm has 250 properties, about 25% of which are in the Boston area, with the rest in San Francisco, New York and San Diego.

Alexandria indicates that it could develop a site of up to 650,000 square feet at 5, 10 and 15 Necco Street in Boston’s Fort Point neighborhood. At the company’s recent second-quarter earnings call, Peter Moglia, co-chief executive officer and co-chief investment officer of Alexandria, discussed the plans for a laboratory facility to be built next to the future site of General Electric’s future world headquarters.

The site “represents a strategic opportunity to expand Alexandria’s unparalleled, world-class” life science development in the Boston area, Moglia stated.

In May, Alexandria and National Development, based in Newton, Massachusetts, bought a 2.7-acre plot of land fronting the Fort Point Channel. The price was $252 million. There is a renovated 95,000-square-foot warehouse on the property that GE has leased for 12 years. Zoning allows for a 12-story commercial building.

Aside from that investment, the two firms recently spent $81.1 million in March to buy a multi-level parking garage at 10 Necco Street. Alexandria also partnered with Anchor Line Partners to develop a nine-story laboratory facility in South Boston at 99 A Street.

According to Alexandria’s 10Q filing for the quarter, it invested $12.872 billion in real estate as of June 30, up from the same period the year before of $11.913 billion. Its total assets for the half-year period total $16.039 billion. Total liabilities, noncontrolling interests and equity hit $16.039 billion.

Revenues for the quarter totaled $373.9 million, and for the six-month period, $723.7 million. Total expenses for the quarter were $309.4 million and for the half-year mark, $616.2 million.

The firm also notes that in addition to its U.S. properties, it has three operating properties in Canada and one in China.

Of the Necco site, Moglia said Alexandria is planning an “iconic … world-class life-science building with a robust and vibrant set of ground-floor amenities. At this point, the company believes it will break ground in early 2020.

Other recent projects have included: in April, the launch of Phase 1 of the Alexandria Center for AgTech – Research Triangle, the first and only fully integrated, multi-tenant agtech R&D and greenhouse camps in Research Triangle; in June, a partnership with Columbia University to open its second Alexandria LaunchLabs in New York City, planned for the spring of 2020; and also in June, opened the first facilities with a tech-focused opioid rehabilitation campus in Dayton, Ohio in partnership with Verily Life Sciences.

Earlier this month Alexandria and TMG Partners won full project approval to develop the 88 Bluxome campus in the San Francisco area.

“88 Bluxome will bring an exceptional mix of much-needed community benefits and retail amenities to SoMa while it provides a dynamic campus environment to spur innovation,” stated Terezia Nemeth, senior vice president of real estate development and community relations at Alexandra. “We have worked closely with the City of San Francisco and our community partners to effect a new model for urban development, one that supports the world’s leading innovators, embraces excellence in sustainability and takes a holistic approach to engaging and activating the community. Alexandria is committed to making a meaningful and lasting impact in all of the communities where we develop and operate, and beyond.”

https://www.biospace.com/article/alexandria-real-estate-equities-plans-another-boston-lab-facility/

Fitbit cuts 2019 revenue view, Versa Lite sales lag; shares tank

Wearable device maker Fitbit Inc cut its 2019 revenue forecast on Wednesday, blaming disappointing sales of its newly launched cheapest smartwatch Versa Lite, sending its shares tumbling as much as 16% to a record low.

Fitbit in March launched Versa Lite, priced at $160, compared with the $200 the full version sells for. The watch, which can track workouts and heart rate, lack features such as the ability to store music directly.

“While Versa Lite received good present consumer reviews, we saw that consumers were willing to pay more for a smartwatch with additional features or look for discounting versus everyday value,” Chief Executive Officer James Park said during a post earnings call with analysts.

The company had moved into the smartwatch market to cushion the hit from slowing growth of its popular colorful fitness trackers, but has faced tough competition from deeper-pocket companies such as Apple Inc and Samsung Electronics.

Smartwatch revenue decreased 27% year-over-year in the second quarter.

On the call, Chief Financial Officer Ron Kisling also said the company anticipates burning cash in the first three quarters before generating cash in the fourth.

Fitbit lowered its 2019 revenue forecast to between $1.43 billion and $1.48 billion, compared with its prior expectations of $1.52 billion to $1.58 billion.

The disappointing performance of Versa Lite suggests the overall health of the business is not as strong as we had thought, DA Davidson analyst Thomas Forte said.

Versa Lite also weighed on average selling price, which fell 19% to $86 per device and missed Wall Street expectations of $91, according to research firm FactSet.

Some analysts also pointed to the weak performance of the company’s health business – widely seen as a growth driver – that connects users with doctors, hospitals and lifestyle coaches.

Fitbit has been partnering with health insurers and making tuck-in acquisitions in the healthcare market as part of efforts to diversify its revenue stream.

Wedbush Securities analyst Alicia Reese said the 16% growth in the business during the second quarter was underwhelming and investors would want to see more if the segment is the major growth driver for Fitbit.

The business reported a 70% growth in the preceding quarter to post revenue of $30.5 million.

Fitbit estimated revenue of between $335 million and $355 million for the third quarter, below analysts’ a
verage estimate of $399.4 million, according to IBES data from Refinitiv. (https://reut.rs/2ynoknd)

The company also forecast an adjusted loss of between 9 cents and 11 cents per share. Analysts were expecting a profit of 2 cents per share.

Excluding items, the company lost 14 cents per share in the second quarter ended June 30, smaller than estimates of 18 cents loss.

Revenue rose about 5% to $313.6 million, beating analysts’ average estimates of $312 million.

The company’s shares have fallen 15.5% this year to Wednesday’s close.

https://www.marketscreener.com/news/Fitbit-cuts-2019-revenue-view-Versa-Lite-sales-lag-shares-tank–28990725/

Theravance Biopharma EPS beats by $0.50, beats on revenue

Theravance Biopharma (NASDAQ:TBPH): Q2 GAAP EPS of -$0.72 beats by $0.50.

Revenue of $26.15M (+11.4% Y/Y) beats by $14.22M.

Press Release

https://seekingalpha.com/news/3484128-theravance-biopharma-eps-beats-0_50-beats-revenue

Translate Bio’s MRT5005 encouraging in early-stage CF study

Preliminary results from a Phase 1/2 clinical trial, RESTORE-CF, evaluating single and ascending doses of Translate Bio’s (NASDAQ:TBIO) inhaled mRNA therapeutic MRT5005 in cystic fibrosis (CF) patients showed a positive effect at certain doses.

Data from the single ascending dose (SAD) portion in 12 CF patients (participants received either 8 mg, 16 mg, 24 mg or placebo) showed that the 16 mg dose was the most effective in terms of improved lung function (ppFEV1) with a mean maximum increase from baseline of 15.7%. All three subjects in this arm experienced maximum increases of 11.1 – 22.2%. The treatment effect in the 8 mg arm was not much better than placebo while the 24 mg arm was better than placebo but not as significant as the 16 mg arm.

On the safety front, the number of treatment-related adverse events in the three arms were 28, 25 and 33, respectively, compared to 11 in the control arm. All were mild or moderate. The most common were cough and headache.

The company plans to add a 20 mg dose cohort to the SAD portion. Preliminary data from this arm and the multiple ascending dose portion should be available in 2020.

Additional results from this initial dataset will be presented at the North American Cystic Fibrosis Conference in Nashville, TN, October 31 – November 2.

Orphan Drug-tagged MRT5005 is designed to address the underlying cause of CF by delivering mRNA encoding fully functional cystic fibrosis transmembrane conductance regulator (CFTR) protein to the lung epithelial cells through nebulization.

Management will host a conference call today at 8:00 am ET to discuss the results.

https://seekingalpha.com/news/3484147-translate-bios-mrt5005-shows-encouraging-action-early-stage-cf-study

Translate Bio misses on revenue

Translate Bio (NASDAQ:TBIO): Q2 GAAP EPS of -$0.57.

Revenue of $1.17M misses by $0.13M.

Press Release

https://seekingalpha.com/news/3484174-translate-bio-misses-revenue

Regenxbio out-licenses gene therapy vector to Pfizer

REGENXBIO (NASDAQ:RGNX) inks an agreement with Pfizer (NYSE:PFE) granting it a non-exclusive global license, with sublicense rights, to its NAV AAV9 vector for the development and commercialization of gene therapies for the treatment of a rare inherited neurodegenerative movement disorder called Friedreich’s ataxia.

Under the terms of the deal, RGNX will receive an upfront payment, milestones and royalties on net sales. Specific financial terms are not disclosed.

https://seekingalpha.com/news/3484198-regenxbio-licenses-gene-therapy-vector-pfizer