TMDI = Titan Medical Inc. (“Titan” or the “Company”) (TSX: TMD) (Nasdaq: TMDI), a medical device company focused on the design, development and commercialization of a robotic surgical system for application in minimally invasive surgery (“MIS”), announced today that it has determined not to proceed with the public offering of units of the Company for which it filed a final short form prospectus on October 31, 2019. The Company has made this decision based on its assessment of market conditions, and intends to pursue alternative financing options. Titan was planning to issue Units at a price of US $0.45 per Unit for total gross proceeds of a minimum of US $15,000,000 and a maximum of US $25,000,000.
RL = Reports Q2 revenue $1.7B, consensus $1.69B. “We delivered second quarter results slightly ahead of our overall expectations, including better than expected revenues, operating margin, and double-digit EPS growth, amid a more challenging operating environment,” said Patrice Louvet, President and CEO. “Our progress was driven by a continued focus on brand elevation and creating immersive lifestyle experiences that are amplified across our stores and digital marketing and commerce channels around the world, while also maintaining expense discipline.” North America revenue in the second quarter decreased 1% to $881 million. In retail, comparable store sales in North America were up 2%, driven by a 2% comp increase in brick and mortar stores and 2% increase at ralphlauren.com. North America wholesale revenue decreased 6%. North America revenue in the second quarter decreased 1% to $881 million. In retail, comparable store sales in North America were up 2%, driven by a 2% comp increase in brick and mortar stores and 2% increase at ralphlauren.com. North America wholesale revenue decreased 6%. Asia revenue in the second quarter increased 4% to $255 million on a reported basis and 5% in constant currency, driven by solid growth in retail. Comparable store sales in Asia increased 1%, reflecting growth in both brick and mortar and digital commerce operations, partly offset by declines in Hong Kong.
DISH = Reports Q3 revenue $3.17B, consensus $3.15B. The company closed the third quarter with 12.18 million total Pay-TV subscribers, including 9.49 million DISH TV subscribers and 2.69 million Sling TV subscribers. Net pay-TV subscribers increased approximately 148,000 subscribers in the third quarter, compared to a decline of approximately 341,000 in the third quarter 2018. DISH Network announced that its Board of Directors has approved a proposed rights offering to raise proceeds of approximately $1B. All DISH stockholders will be granted the right to participate in the offering and subscribe for newly-issued shares on a pro rata basis. The proceeds from the rights offering are intended to be used for general corporate purposes, including investments in the wireless business. DISH intends to distribute transferable subscription rights pro rata to holders of record of DISH’s Class A and B common stock, and outstanding convertible notes (based on the number of Class A shares into which those notes are convertible as of the record date) on November 17, 2019. The subscription rights will entitle the holder to acquire newly-issued shares of DISH’s Class A common stock. The subscription price will be $33.52 per share of Class A common stock. The rights offering will not provide for over-subscription rights. Charles Ergen, who beneficially owns approximately 51.6% of DISH’s Class A and Class B common stock (calculated assuming conversion of all outstanding Class B common stock into Class A common stock) as of October 31, 2019, has informed DISH that he intends to fully exercise all subscription rights allocated in respect of the shares he beneficially owns. DISH had 254,623,280 shares of Class A common stock and 238,435,208 shares of Class B common stock outstanding as of October 31, 2019. All outstanding shares of Class B common stock are beneficially owned by Ergen. To the extent any subscription rights would expire unexercised following the expiration of the rights offering, Ergen also intends to purchase all shares of Class A common stock that are not subscribed for by stockholders in connection with the rights offering. DISH expects to enter into a commitment letter with Ergen memorializing this intention.
CLVS = Clovis Oncology, Inc. (NASDAQ:CLVS) reported financial results for the quarter ended September 30, 2019, and provided an update on Clovis’ clinical development programs and regulatory and commercial outlook for the remainder of 2019.
- $37.6M in Rubraca® (rucaparib) net product revenue for Q3 2019, up 65% year over year
- Net product revenue increased 14% sequentially in Q3 2019 compared to Q2 2019, including sequential U.S. sales increase of 12%
- Increased FY2019 global net product revenue guidance to $141M-$147M
- Q3 2019 operating cash burn reduced from Q2 2019 by 42%; net cash burn reduced to $45M
- $354.1M in cash, cash equivalents and available for sale securities at September 30, 2019; anticipated cash runway into 2H 2021
- Supplemental NDA for Rubraca in patients with BRCA1/2-mutant advanced prostate cancer to be filed before year-end
- Lucitanib combination studies enrolling; initial data anticipated at medical meetings beginning mid-2020
- Acquired rights to FAP-2286, radiopharmaceutical targeting FAP; Clovis currently planning to file IND in 2H 2020
“We are extremely pleased with our progress made on all fronts during the third quarter. We reported encouraging quarter-over-quarter revenue growth in the U.S. and in October launched in England with reimbursement now provided via the Cancer Drugs Fund,” said Patrick J. Mahaffy, CEO and President of Clovis Oncology. “The TRITON2 prostate data presented at ESMO were very encouraging, and we remain on track to file the supplemental New Drug Application for patients with a BRCA1/2 mutation in advanced prostate cancer before year-end. We are pleased that the lucitanib combination studies are now enrolling patients, in particular the combination with nivolumab. And finally, we look forward to providing updates for FAP-2286, our recently-licensed FAP-targeted radiopharmaceutical compound, as we move this preclinical candidate forward.”
Third Quarter 2019 Financial Results
Clovis reported net product revenue for Rubraca of $37.6 million for Q3 2019, which included U.S. net product revenue of $36.5 million and ex-U.S. net product revenue of $1.1 million, compared to net product revenue for Q3 2018 of $22.8 million. Total revenue increased 14 percent sequentially from Q2 2019 to Q3 2019, including a 12 percent increase in U.S. revenues.
Clovis now expects global net product revenue to be in the range of $141 million to $147 million for the full year 2019.
The supply of free drug distributed to eligible patients through the Rubraca patient assistance program for Q3 2019 was lower at 20 percent of the overall commercial supply, compared to 22 percent in Q2 2019 and 30 percent reported in Q3 2018. This represented $9.0 million in commercial value for Q3 2019 compared to $9.6 million in Q3 2018.
Net product revenue for the first nine months of 2019 was $103.7 million, as compared to net product revenue of $65.0 million for the first nine months of 2018. For the nine-month period ended September 30, 2019 the supply of free drug distributed to eligible patients was an additional approximately 21 percent of the overall commercial supply compared to 26 percent in the first nine months of 2018. This represented $26.7 million in commercial value for the nine months ended September 30, 2019, compared to $23.0 million in the comparable period in 2018.
Clovis had $354.1 million in cash, cash equivalents and available-for-sale securities as of September 30, 2019. In August 2019, Clovis completed a private placement sale of $263.0 million aggregate principal amount of 4.50 percent convertible senior notes due 2024. The net proceeds from the offering were $255.0 million, after deducting underwriting discounts and commissions, and offering expenses. A portion of the proceeds, totaling $171.8 million, were used to repurchase $190.3 million of par value of convertible senior notes due 2021, with the remainder of $83.2 million to be used for general corporate purposes. As of September 30, 2019, the Company also had up to $154 million remaining to draw under the TPG ATHENA clinical trial financing agreement to fund the expenses of the ATHENA trial through Q3 2022.
Based on the Company’s anticipated revenues, spending, available financing sources and existing cash, cash equivalents and available-for-sale securities, the Company believes it has sufficient cash, cash equivalents and available-for-sale securities to fund its operating plan into the second half of 2021. This does not include any cash repayment that may be required to pay off (unless refinanced earlier) the remaining $97 million principal amount of convertible notes at their maturity due September 2021.
BNGO = Bionano Genomics, Inc. (Nasdaq: BNGO) announced today that Novogene has adopted the Saphyr system for genome imaging and incorporated it into their expansive repertoire of genome analysis technology services. Novogene is one of the premier genome analysis technology providers in the world. We believe the addition of Bionano technology could enable Novogene’s global customers to achieve comprehensive analysis of platinum genome assembly, and genome structure, including highly accurate detection of genomic structural variations that remain unresolved by current next-generation sequencing (NGS) technology and other methods.
Novogene’s capacity for genome analysis is among the largest and most advanced in the world. With service facilities spanning the globe, and headquarters in Beijing, China, Novogene offers access to cutting edge technologies and bioinformatics expertise to the largest genomics markets in the world. Their customers include academic and industrial scientists and clinicians from the most prestigious universities and pharmaceutical companies around the world. We believe that Novogene’s adoption of Bionano’s Saphyr system for ultra-sensitive and ultra-specific genome-wide detection of structural variation reflects the ability of the technology to serve as a powerful tool in the genome analysis toolbox.
Novogene will offer Saphyr services globally throughout the research and clinical communities for human, plant and animal research, including, but not limited to, basic human research, translational research for variant discovery and clinical research in cancer and genetic diseases. In addition, data generated with the Saphyr system can be integrated with the extensive array of Novogene’s offerings, including NGS, gene expression analysis, and single-cell sequencing, enabling a multi-omics approach to reveal more answers than any one technology can on its own.
“The world will now have greater access to experience the genomic structural resolution only achieved by Saphyr, which could enable groundbreaking discoveries for a wide array of biological research. Having Saphyr become part of the Novogene offering is a significant milestone for Bionano and for Saphyr. Novogene is known by us to adopt only technologies with significant demand in the market. We are grateful to our partners there and look forward to a productive relationship that could result in the proliferation of Bionano data throughout the genomics community. With more and more genome analysis scientists and clinicians becoming familiar with the capabilities of Saphyr, we expect its adoption and utilization will expand,” said Erik Holmlin, Ph.D., CEO of Bionano Genomics.
“The Saphyr system is a stable platform with significant utility. We have observed the growth and development of Bionano for some time and now our customers are seeking the kind of data that Saphyr provides. We look forward to this partnership being very successful for both companies and our customers,” said Dr. Ruiqiang Li, CEO of Novogene.
BIDU = Baidu, Inc. (NASDAQ: BIDU) the leading Chinese-language Internet search provider, today announced its unaudited financial results for the third quarter ended September 30, 2019.
“Baidu App traffic continues to grow robustly with DAUs reaching 189 million, up 25% year over year, in September and Baidu’s in-app search continues to gain market share. Our focus to combine search and feed and expand Baidu App’s content and services offerings is improving user experience and drawing publishers and service providers to place more content and services on Baidu’s hosted platform, which in turn draws more users. This positive reinforcing cycle has been a contributing factor to Baidu Core’s operating margin rising 1,400 basis points from the prior quarter,” said Robin Li, Chairman and CEO of Baidu. “On Baidu’s new AI businesses, DuerOS voice assistant continues to experience strong momentum with monthly voice queries surpassing 4.2 billion in September, up over 4.5 fold year over year. On Apollo, we are excited about our progress in early-stage commercialization of smart transportation with the release of Apollo-powered robotaxi pilot program to the public in Changsha, Hunan in September.”
“Baidu delivered a solid third quarter with total revenues reaching RMB 28.1 billion, up 7% sequentially on top of the 9% sequential growth from the prior quarter, in spite of the softening macro environment, industry-specific policy changes and self-directed healthcare initiative,” said Herman Yu, CFO of Baidu. “Our disciplined approach to spending, focusing on investment returns across the board, sheds light on the strong and improving margin contribution from in-app search and feed.”
Morgan Stanley upgraded Baidu to Overweight from Equal Weight.
DXCM = DexCom, Inc. (Nasdaq: DXCM) today reported its financial results as of and for the quarter ended September 30, 2019.
Third Quarter 2019 Highlights:
- Revenue grew 49% versus the same quarter of the prior year to $396.3 million
- U.S. revenue growth of 53% and international revenue growth of 36%
- GAAP operating income of $56.0 million or 14% of revenue, an increase of 890 basis points compared to the third quarter of 2018. Non-GAAP operating income* of $59.1 million or 15% of revenue, an increase of 940 basis points over the third quarter of 2018.
- 3-Year COMISAIR1 study results continued to demonstrate the value proposition of Dexcom’s real-time CGM:
- Significant improvements to A1C and time in range for Dexcom CGM subgroups regardless of one’s method of insulin delivery
- Time in range increased by more than 20% for CGM use in conjunction with both MDI and pump cohorts, nearly 5 hours per day of additional glycemic control
- “Dexcom maintained its robust revenue growth momentum in the third quarter, leading to another significant increase to our full year revenue outlook,” said Kevin Sayer, Dexcom’s Chairman, President and CEO. “Our team is working hard to meet demand and ensure an exceptional experience for our customers, and we look forward to a strong close to 2019.”
2019 Annual Guidance
Dexcom updated its revenue, operating margin, and adjusted EBITDA expectations and brought gross profit guidance slightly below the previous range for full fiscal year 2019:
Revenue of $1.425 billion to $1.450 billion (38% – 41% growth) compared to previous expectations of $1.325 billion to $1.375 billion (28% – 33% growth)
Gross profit margin of approximately 63% compared to previous expectations of 64% to 65%
Non-GAAP operating margin of approximately 9% versus previous expectations of 7%
Non-GAAP adjusted EBITDA margin of approximately 19.5% versus previous expectations of 18.5%
Third Quarter 2019 Financial Results
Revenue: In the third quarter of 2019, worldwide revenue grew 49% to $396.3 million, up from $266.7 million in the third quarter of 2018. Volume growth in conjunction with strong new patient additions continues to be the primary driver of revenue growth as awareness of real-time CGM increases.
Gross Profit: Gross profit totaled $246.9 million or 62.3% of sales for the third quarter of 2019, compared to $168.6 million or 63.2% of sales in the third quarter of 2018.
Operating Income: GAAP operating income for the third quarter of 2019 was $56.0 million, compared to a GAAP operating income of $13.9 million for the third quarter of 2018.
Raymond James analyst Jayson Bedford raised his price target for DexCom to $189 from $172 following the company’s Q3 results. In a research note to investors, Bedford says that while there will always be competitive “noise,” Dexcom remains one of the best growth stories in MedTech, supporting his Outperform rating.
Baird analyst Jeff Johnson raised his price target on DexCom to $240 from $195 following strong Q3 results. The analyst noted revenues easily beat the Street and management raised guidance which he believes could drive sustainable upward momentum for the stock as Libre concerns have faded, G7’s launch is creeping closer, and the power of pharmacy access is increasingly being felt. Johnson reiterated his Outperform rating on DexCom shares.
Jefferies analyst Raj Denhoy raised his price target for DexCom to $200 from $180 saying the company posted another “blowout” quarter as continuous glucose monitoring adoption trends “show no signs of abating.” The company’s U.S. growth was 53% and outside U.S. growth 39%, Denhoy tells investors in a research note. He keeps a Buy rating on the shares.
Oppenheimer analyst Steven Lichtman raised his price target for $205 from $180 and maintained an Outperform rating following the company’s Q3 results which significantly exceeded the Street’s expectations, led by outperformance in both U.S. and International. While competition remains high, overall market acceleration continues and DexCom has numerous drivers ahead including continuing pharmacy channel expansion, pump partner launches, recent G6 launch for Medicare patients, international expansion and G7, Steven Lichtman tells investors in a research note.
JPMorgan analyst Robbie Marcus raised his price target for DexCom to $215 from $190 saying the company “posted another outstanding quarter.” While management raised sales guidance by a little less than twice the Q3 beat, the implied Q4 guide is “readily achievable/beatable,” Marcus tells investors in a post-earnings research note. He sees “clear momentum” setting up a “bullish” 2020 for DexCom and reiterates an Overweight rating on the shares.