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‘Much Ado About Dying’ film as IDFA-winning doc, bought for US by First Run Features

“Much Ado About Dying,” Scott Chamber’s documentary about elderly care that won the best directing award at IDFA in 2022, has been acquired by First Run Features for the U.S. and Canada.

 

The feature, produced by Soilsiú Films and Tiffin Films, will have its U.S. festival premiere at the Santa Barbara International Film Festival ahead of a national theatrical release set to launch at New York’s Film Forum on March 15.

 

Chambers’ third feature-length documentary, “Much Ado About Dying” deals with the issue of caring for elderly and dying relatives. Producers describe the film as “poignant and moving, but also hilariously funny,” following Chambers as he get very close to his dying uncle, a retired gay actor who still wants to perform “King Lear” before it’s too late. The director’s previous films, “Every Good Marriage Begins With Tears” and “Cowboys in India,” both toured the festival circuit extensively before broadcast outings in the U.K. on BBC Storyville and Channel 4 respectively.

 

“We are delighted to be working with Marc Mauceri and his team at First Run Features,” said Soilsiú Films’ David Rane, who distributed Soilsiú’s previous title, “Young Plato,” directed by Neasa Ní Chianáin and Declan McGrath.

 

“It’s a challenge these days to get an arthouse documentary out into U.S. cinemas, even one as charming and funny as ‘Much Ado About Dying,’ and we appreciate the motivation and commitment of the teams at First Run Features and Film Forum in releasing Simon’s beautifully directed film. This film deserves to be seen on the big screen, and there’s no better team to put it there.”

 

New York-based First Run, well-known for its 45-year history in the indie distribution world, has previously released four editions of Michael Apted’s “Up” Series (“28 Up,” “42 Up,” “49 Up” and “56 Up”) as well as the “Quiet Epidemic,” “Before Stonewall,” “Scrap” and “The Life and Times of Allen Ginsberg.”

 

“’Much Ado About Dying’ is a moving and hilarious cinema documentary about growing old unapologetically and the often-invisible family members who care for us in our twilight years,” said First Run’s Mauceri. “We are honoured to be entrusted by director Simon Chambers to share his uncle’s story with audiences here in the USA. Soilsiú Films are becoming more prolific by the year in producing world class documentaries for cinema and we are delighted to be working with them after the success they had in the U.S. with ‘Young Plato.’”

 

See the trailer for “Much Ado About Dying” below.

 

 

 

Read More

 

 

 

— Variety

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Business Culture Digital - AI & Apps Regulations & Security Sports & Gaming Technology

Computer programmer, Gary Bowser, faces up to 40 months prison time in 2022 for pirating games, ordered to pay $14.5M to Nintendo

Patricia Hernandez / The Guardian:

 

 

—  The hacker whose involvement with anti-piracy software ended in a jail sentence has emerged from prison struggling to make rent as he starts paying his fine. ‘It could be worse,’ he says.

‘The sentence was like a message to other people’ … Gary Bowser in Toronto in August 2023.Photograph: Andrew Francis Wallace/Toronto Star/Getty Images

 

 

In April 2023, a 54-year-old programmer named Gary Bowser was released from prison having served 14 months of a 40-month sentence. Good behaviour reduced his time behind bars, but now his options are limited. For a while he was crashing on a friend’s couch in Toronto. The weekly physical therapy sessions, which he needs to ease chronic pain, were costing hundreds of dollars every week, and he didn’t have a job. And soon, he would need to start sending cheques to Nintendo. Bowser owes the makers of Super Mario $14.5m (£11.5m), and he’s probably going to spend the rest of his life paying it back.

 

Since he was a child, Bowser’s life has revolved around tinkering with electronics. His dad was a mechanical engineer, and he learned from him how to wire up model trains and mod calculators. As a teenager he already had a computer business: his mother died when he was 15, his father had retired and Bowser supported him.

Gary Bowser, left, in his 20s demonstrating projects for the TI-99 home computer event at the Chicago TI fair in the early 90s. Photograph: Courtesy of Gary Bowser

Bowser would go on to run an internet cafe, where patrons played Counter-Strike and Dance Dance Revolution, and repair hardware for a living. He got briefly caught up with the law during a stint fixing games consoles at flea markets, which nearly implicated him alongside vendors who sold pirated movies. Eventually he moved to the Dominican Republic in 2010. He spoke no Spanish for years, but he loved the place anyway: you could drive from one end to the other in just 12 hours, he recalls. It was here that Bowser – who, in a case of nominative determinism that feels almost too trite to acknowledge, shares a name with Super Mario’s in-game antagonist – started becoming the face of Nintendo piracy.

 

 

In the late 00s he made contact with Team Xecuter, a group that produces dongles used to bypass anti-piracy measures on Nintendo Switch and other consoles, letting them illegally download, modify and play games. While he says he was only paid a few hundred dollars a month to update their websites, Bowser says the people he worked with weren’t very social and he helped “testers” troubleshoot devices.

 

“I started becoming a middleman in between the people doing the development work, and the people actually owning the mod chips, playing the games,” he says. “I would get feedback from the testers, and then I would send it to the developers … I can handle people, and that’s why I ended up getting more involved.”

 

In September 2020, he was arrested in a sting so unusual that the US Department of Justice released a press release boasting about the indictment, in which acting assistant attorney general Brian C Rabbitt called Bowser and his co-defendants “leaders of a notorious international criminal group that reaped illegal profits for years by pirating video game technology of US companies.”

 

“The day that it happened, I was sleeping in my bed, it was four in the morning, I’d been drinking all night,” Bowser says. “And suddenly I wake up and see three people surrounding my bed with rifles aimed at my head … they dragged me out of the place, put me in the back of a pickup truck and drove me to the Interpol office.”

 

Bowser was arrested at the height of the pandemic, which complicated everything. He was imprisoned in a series of jails, and each transfer had Covid safety precautions that required him to spend time in isolation. Despite this, Bowser still caught the coronavirus and spent two weeks so sick that, he says, a priest would come over once a day to read him a prayer.

 

Bowser was charged with fraud over his connection to Team Xecuter. While in custody, he was also hit with a civil suit from Nintendo. Between the civil and criminal cases, he was ordered to pay $14.5m.

 

In transcripts from the court, Nintendo’s lawyer Ajay Singh outlined the company’s case against piracy. “It’s the purchase of video games that sustains Nintendo, and it is the games that make the people smile … It’s for that reason that we do all we can to prevent games on Nintendo systems from being stolen,” he told the judge.

 

Pirates are usually fined in court, but Bowser’s case was meant to draw attention. “The sentence was like a message to other people that [are] still out there, that if they get caught … [they’ll] serve hard time,” he says. As he tells it, Bowser didn’t make or develop the products that sent him to prison; he “just” updated the websites that told people what they could buy, and kept them informed about what was coming next.

 

Bowser maintains that he could have fought the allegations, and that other members of the hacking group remain at large. But fighting against 13 charges would have cost time and money. It was easier, he claims, to plead guilty and only deal with a couple of the charges. As a part of that agreement, Bowser now has to send Nintendo 20-30% of any money left over after he pays for necessities such as rent.

 

 

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— Techmeme

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Business Economics Lifestyle Perspectives Regulations & Security

AM Best revises outlooks to negative for Amica Mutual Insurance Company and subsidiaries

OLDWICK, N.J. — (BUSINESS WIRE) — #insurance — AM Best has revised the outlooks to negative from stable and affirmed the Financial Strength Rating (FSR) of A+ (Superior) and the Long-Term Issuer Credit Rating (Long-Term ICR) of “aa-” (Superior) of Amica Mutual Insurance Company (Amica Mutual) and its wholly owned subsidiary, Amica Property and Casualty Insurance Company (together known as Amica Mutual Group).

 

At the same time, AM Best has revised the outlooks to negative from stable and affirmed the FSR of A+ (Superior) and the Long-Term ICR of “aa-” (Superior) of Amica Life Insurance Company (Amica Life), a wholly owned subsidiary of Amica Mutual. All companies are domiciled in Lincoln, RI.

The Credit Ratings (ratings) reflect Amica Mutual Group’s balance sheet strength, which AM Best assesses as strongest, as well as its adequate operating performance, favorable business profile and appropriate enterprise risk management (ERM).

 

The ratings of Amica Life reflect its balance sheet strength, which AM Best assesses as strongest, as well as its adequate operating performance, neutral business profile and appropriate ERM.

 

The negative outlooks for Amica Mutual Group reflect the decline in its balance sheet strength, specifically a deterioration in risk-adjusted capitalization in recent years. Increased loss costs in both the auto and homeowner’s line of business have driven substantial underwriting losses in 2022 and 2023, which has significantly impacted the group’s surplus position and overall liquidity. Nonetheless, the group’s liquidity profile remains supported by Federal Home Loan Bank borrowing capacity, reinsurance and portfolio cash flow. Additionally, Amica Mutual Group’s results rely heavily on net investment income and realized capital gains, which have contributed collectively to positive net earnings in most years. However, this benefit was muted in 2022 and 2023 due to the turbulent investment markets and rapid increases in interest rates, which caused underwriting losses to outpace investment earnings.

 

AM Best notes that Amica has implemented multiple strategic initiatives, which are expected to correct performance gradually. These include substantial rate increases in both the auto and homeowners’ line of business, as well as a renewed focus on profitable geographic areas and reducing dividends. While this is expected to improve the group’s operating performance in the more near term, it is not expected to replenish its loss of surplus within that same time frame. Additionally, the negative outlooks further reflect the potential for continued capital erosion as management’s strategic action plan comes to fruition.

 

The negative outlooks for Amica Life follow that of Amica Mutual and reflect the potential removal of rating enhancement provided by the property/casualty parent. Given the strong parental support that includes continuous capital contributions, ample liquidity access and the sharing of brand names and consumer base, Amica Life benefits from its relationship with its parent.

 

This press release relates to Credit Ratings that have been published on AM Best’s website. For all rating information relating to the release and pertinent disclosures, including details of the office responsible for issuing each of the individual ratings referenced in this release, please see AM Best’s Recent Rating Activity web page. For additional information regarding the use and limitations of Credit Rating opinions, please view Guide to Best’s Credit Ratings. For information on the proper use of Best’s Credit Ratings, Best’s Performance Assessments, Best’s Preliminary Credit Assessments and AM Best press releases, please view Guide to Proper Use of Best’s Ratings & Assessments.

 

AM Best is a global credit rating agency, news publisher and data analytics provider specializing in the insurance industry. Headquartered in the United States, the company does business in over 100 countries with regional offices in London, Amsterdam, Dubai, Hong Kong, Singapore and Mexico City. For more information, visit www.ambest.com.

 

Copyright © 2024 by A.M. Best Rating Services, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

Contacts

Cristian Sieira
Financial Analyst
+1 908 882 2315
cristian.sieira@ambest.com

Christopher Sharkey
Associate Director, Public Relations
+1 908 882 2310
christopher.sharkey@ambest.com

Erik Miller
Director
+1 908 882 2120
erik.miller@ambest.com

Al Slavin
Senior Public Relations Specialist
+1 908 882 2318
al.slavin@ambest.com

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Fork & Good hosts first ever tasting of hybrid cultivated meat at Davos

The food startup shared its product with thought leaders and local residents at its first large-scale tasting since the launch of its pilot facility last year

 

 

DAVOS, Sz. — (BUSINESS WIRE) — On Jan. 16, heads of state, industry experts and business leaders gathered for the annual World Economic Forum conference at Davos.

 

At the same time, a smaller, though no less consequential, event took place just 10 minutes away at Sonas Irish Pub. Food startup Fork & Good conducted the city’s first blind tasting of hybrid cultivated meat to gather feedback from an eclectic group of 40 people.

 

Participants each received two small dishes distinguished by blue and yellow stickers. One contained 100% conventional pork and the other a blend of 30% cultivated and 70% conventional pork. (Willing vegetarians also had a chance to enjoy dumplings made with a blend of plant and cultivated pork).

 

“Mixing cultivated meat with conventional meat has many advantages,” said Fork & Good Chief Scientific Officer Gabor Forgacs.

 

“It helps alleviate the rising supply chain and environmental challenges meat producers face. It also allows for the gradual introduction of cultured meat through products consumers are already used to.”

 

Perhaps most importantly, it tastes just like meat — because it is 100% meat. As Fork & Good co-founders expected, participants at the blind tasting found no major difference between the two samples. An informal poll after the tasting showed more than half of the group preferred the 30/70 blend over conventional meat on its own. The group was equally split when asked to guess which dish contained cultivated meat.

 

The tasting was led by Fork & Good CEO Niya Gupta, who said, “We are aiming to serve everyone everywhere with affordable meat so it’s exciting to get input in this open and democratic way. We had everyone, from an American professor to a Swedish nonprofit worker to a Chinese student — even a regular Swiss person walking in off the street looking for a beer. Their feedback has been critical to us as we continue our product development journey.”

 

One of the participants, global data science leader Dr. Richard Kerr, said, “I wasn’t able to tell the difference between the samples, to the point that I thought it was going to be revealed that all the samples were 100% cultured. I love the idea, and will continue to follow [Fork & Good’s] progress with interest.”

 

The lunchtime tasting was a part of UnDavos, an informal entrepreneurship-focused gathering that takes place the same week as the WEF conference. Mark Turrell, founder of UnDavos and CTO of Fresh Solutions AI, invited Fork & Good to present their product at a “meal for the future” event.

 

“It was amazing to physically experience technology being integrated into our food — the food in our mouths,” Turrell said.

 

In addition to the blind tasting, Fork & Good was invited to the main WEF conference as a Technology Pioneer, one of just 100 early-stage startups developing innovative technologies to address global challenges. Gupta participated in back-to-back meetings and roundtables, including a bilateral meeting with one of the world’s largest meat producers who couldn’t tell the difference between conventional meat and Fork & Good’s hybrid cultivated meat.

 

Founded in 2018, Fork & Good launched its pilot facility in Jersey City, New Jersey. The facility is already capable of producing six to ten times more meat per square foot than is currently possible by conventional means. Fork & Good’s cultivated meat is ready for market, pending regulatory approval by the FDA and USDA.

 

ABOUT FORK AND GOOD

From its facility in Jersey City, Fork & Good is on a mission to grow the best of meat for everyone, everywhere. The company takes a novel approach to cultivating meat by growing muscle cells directly in proprietary bioreactors for maximum flavor and nutritional value—while drastically reducing the amount of land and water used in conventional livestock production. The team has 150+ years of combined experience that spans food, agriculture, and science, and is committed to helping build the industry in a safe, transparent way. Learn more at: www.forkandgood.com.

 

Contacts

Emily Bogan, Business Operations Manager

Email: hello@forkandgood.com
Phone: (201) 201-1392

Categories
Business Economics Healthcare Lifestyle Local News Science

Bristol Myers Squibb reports fourth quarter and full-year financial results for 2023

Results Reflect Continued Strength of In-Line and New Products, Pipeline Execution and Business Development Activity, Supporting Growth Momentum into 2024

 

  • Reports Fourth Quarter Revenues of $11.5 Billion; GAAP EPS of $0.87 and Non-GAAP EPS of $1.70
    • In-Line and New Product Portfolio Revenues Increased 9% to $9.8 Billion
  • Reports Full-Year Revenues of $45.0 Billion; GAAP EPS of $3.86 and Non-GAAP EPS of $7.51
    • In-Line and New Product Portfolio Revenues Increased 7% to $37.9 Billion
  • Strengthens Long-Term Growth Profile Through Multiple Transactions, Including Planned Acquisitions of Karuna Therapeutics and RayzeBio and Strategic Collaboration with SystImmune; Completes Purchase of Mirati Therapeutics
  • Advances Research Pipeline Including U.S. Approval of Augtyro and FDA Acceptance of sBLAs for Breyanzi in Follicular Lymphoma and Mantle Cell Lymphoma for Priority Review
  • Provides 2024 Guidance with Revenues Increasing by Low Single-Digits; Non-GAAP EPS Range $7.10 to $7.40, Excludes Impact of Pending Transactions

 

 

PRINCETON, N.J. — (BUSINESS WIRE) — Bristol Myers Squibb (NYSE: BMY) today reports results for the fourth quarter and full year of 2023, which reflect strong pipeline acceleration, continued portfolio diversification, and momentum in our business.

“We saw good performance in the fourth quarter from our in-line and new products and took several actions to strengthen the company and build a foundation for sustainable growth,” said Christopher Boerner, Ph.D., chief executive officer, Bristol Myers Squibb.

 

“In 2024, our focus is on delivering strong commercial execution and accelerating opportunities that enhance our growth profile in the middle of the decade and beyond.”

 

 

Fourth Quarter

Full Year

$ in millions, except per share amounts

2023

2022

Change

Change Excl.

F/X**

2023

2022

Change

Change Excl.

F/X**

Total Revenues

$11,477

$11,406

1%

1%

$45,006

$46,159

(2)%

(2)%

EPS — GAAP*

0.87

0.95

(8)%

N/A

3.86

2.95

31%

N/A

EPS — Non-GAAP*

1.70

1.82

(7)%

N/A

7.51

7.70

(2)%

N/A

Acquired IPRD charge and Licensing Income Net Impact (Decrease)/Increase

(0.20)

(0.01)

N/A

N/A

(0.28)

(0.24)

N/A

N/A

* GAAP and Non-GAAP earnings per share include the net impact of Acquired IPRD charges and licensing income.

** See “Use of Non-GAAP Financial Information”.

 

 

FOURTH QUARTER RESULTS

All comparisons are made versus the same period in 2022 unless otherwise stated.

  • Bristol Myers Squibb posted fourth quarter revenues of $11.5 billion, an increase of 1% both on a reported and when adjusted for foreign exchange basis, primarily due to higher sales of new product portfolio, as well as Eliquis and Opdivo, partially offset by lower sales of Revlimid.
  • U.S. revenues increased 1% to $8.0 billion primarily due to higher sales of new product portfolio, Eliquis and Opdivo, partially offset by lower sales of Revlimid.
  • International revenues remained relatively flat at $3.5 billion, primarily due to lower sales of Revlimid, offset by higher sales ofnew product portfolio and Opdivo.
  • On a GAAP basis, gross margin decreased from 77.3% to 76.1% and on a non-GAAP basis, gross margin decreased from 77.9% to 76.4% primarily due to product mix and lower hedge settlement gains.
  • On a GAAP and non-GAAP basis, marketing, selling and administrative expenses decreased 9% to $2.1 billion primarily due to timing of spend.
  • On a GAAP and non-GAAP basis, research and development expenses remained relatively flat at $2.5 billion.
  • On a GAAP and non-GAAP basis, Acquired IPRD increased to $600 million from $52 million primarily due to the reacquired mavacamten rights of $445 million in China and certain other Asian territories. On a GAAP and non-GAAP basis, licensing income was $67 million compared to $16 million during the same period a year ago.
  • On a GAAP basis, amortization of acquired intangible assets decreased 3% to $2.3 billion primarily due to the Abraxane marketed product right being fully amortized in the fourth quarter of 2022.
  • On a GAAP basis, income tax benefit was $88 million despite pre-tax earnings of $1.7 billion primarily due to a valuation allowance reversal related to unrealized equity investment losses and foreign currency. In 2022, the income tax benefit was $166 million despite pre-tax earnings of $1.9 billion primarily due to the release of income tax reserves. On a non-GAAP basis, the effective tax rate changed from 10.9% to 14.9%, primarily due to release of income tax reserves in 2022.
  • The company reported on a GAAP basis net earnings attributable to Bristol Myers Squibb of $1.8 billion, or $0.87 per share, compared to $2.0 billion, or $0.95 per share, for the same period a year ago. In addition to the items above, the decrease in GAAP EPS was driven by lower losses in equity investments. The company reported on a non-GAAP basis net earnings attributable to Bristol Myers Squibb of $3.5 billion, or $1.70 per share, compared to $3.9 billion, or $1.82 per share, for the same period a year ago. The EPS results in the fourth quarter of 2023 also include the impact of lower weighted-average common shares outstanding.

 

 

FOURTH QUARTER PRODUCT REVENUE HIGHLIGHTS

($ amounts in millions)

Quarter Ended December

31, 2023

% Change from Quarter

Ended December 31,

2022

% Change from

Quarter Ended

December 31,

2022 Ex-F/X**

U.S.(c)

Int’l

WW(d)

U.S.(c)

Int’l

WW(d)

Int’l

WW(d)

In-Line Products

Eliquis

$

1,899

$

975

$

2,874

11%

1%

7%

(3)%

6%

Opdivo

1,411

976

2,387

12%

3%

8%

4%

8%

Orencia

766

219

985

8%

8%

8%

11%

9%

Pomalyst/Imnovid

632

258

890

1%

2%

1%

—%

1%

Yervoy

343

223

566

(1)%

—%

— %

1%

—%

Sprycel

417

109

526

—%

(32)%

(9)%

(31)%

(9)%

Mature and other products (a)

202

278

480

9%

(6)%

—%

(5)%

1%

Total In-Line Products

5,670

3,038

8,708

8%

(1) %

5 %

(1)%

5%

New Product Portfolio

Reblozyl

274

46

320

75%

10%

61%

5%

60%

Opdualag

187

3

190

80%

N/A

83%

N/A

83%

Abecma

56

44

100

(40)%

42%

(20)%

39%

(21)%

Zeposia

101

32

133

74%

52%

68%

43%

66%

Breyanzi

85

16

101

*

23%

84%

23%

84%

Camzyos

84

4

88

*

N/A

*

N/A

*

Sotyktu

56

7

63

*

N/A

*

N/A

*

Onureg

31

16

47

15%

60%

27%

50%

24%

Inrebic

19

10

29

12%

67%

26%

67%

26%

Augtyro

1

—

1

N/A

N/A

N/A

N/A

N/A

Total New Product Portfolio

894

178

1,072

71%

45%

66%

39%

65%

Total In-Line and New Product Portfolio

6,564

3,216

9,780

13%

1%

9%

1%

9%

Recent LOE Products (b)

Revlimid

1,262

188

1,450

(38)%

(21)%

(36)%

(20)%

(36)%

Abraxane

177

70

247

53%

11%

38%

22%

42%

Total Recent LOE Products

1,439

258

1,697

(33)%

(15)%

(30)%

(11)%

(30)%

Total Revenues

$

8,003

$

3,474

$

11,477

1%

—%

1%

—%

1%

*

In excess of +100%

**

See “Use of Non-GAAP Financial Information”.

(a)

Includes over-the-counter (OTC) products, royalty revenue and mature products.

(b)

Recent LOE Products includes products with significant expected decline in revenue from a prior reporting period as a result of a loss of exclusivity.

(c)

Includes Puerto Rico.

(d)

Worldwide (WW) includes U.S. and International (Int’l).

 

 

FOURTH QUARTER PRODUCT REVENUE HIGHLIGHTS

In-Line Products

Revenues for in-line products in the fourth quarter were $8.7 billion compared to $8.3 billion in the prior year period. In-line products revenue was largely driven by:

  • Eliquis worldwide revenues increased 7%, or 6% when adjusted for foreign exchange impacts. U.S. revenues were $1.9 billion compared to $1.7 billion in the prior year period, representing an increase of 11% primarily due to higher demand, partially offset by GTN adjustments in 2023. International revenues were $975 million compared to $970 million in the prior year period, representing an increase of 1%, or a decrease of 3% when adjusted for foreign exchange impacts, primarily driven by lower average net selling prices and generic erosion in several European countries.
  • Opdivo worldwide revenues increased 8% both on a reported and when adjusted for foreign exchange basis. U.S. revenues increased 12% to $1.4 billion compared to $1.3 billion in the prior year period primarily due to higher demand. International revenues were $976 million compared to $951 million in the prior year period, representing an increase of 3%, or 4% when adjusted for foreign exchange impacts, primarily due to higher demand as a result of launches for new indications and core indications.

New Product Portfolio

  • New product portfolio worldwide revenues increased to $1.1 billion compared to $645 million in the prior year period, representing a growth of 66%, or 65% when adjusted for foreign exchange impacts, primarily driven by higher demand across the portfolio, including for Reblozyl, Opdualag, Camzyos, Sotyktu, Zeposia and Breyanzi.

Recent LOE Products

  • Revlimid worldwide revenues declined to $1.5 billion compared to $2.3 billion in the prior year period, representing a decline of 36%, both on a reported and when adjusted for foreign exchange basis, primarily due to generic erosion.

PRODUCT AND PIPELINE UPDATE

The company recently achieved several important regulatory and clinical milestones. In November 2023, Augtyro received U.S. regulatory approval in non-small cell lung cancer. The U.S. Food and Drug Administration (FDA) also accepted supplemental Biologics License Applications (sBLAs) for Breyanzi to expand into follicular lymphoma and mantle cell lymphoma.

Oncology

Category

Asset

Milestone

Regulatory

KRAZATI®

(adagrasib)

The European Commission (EC) granted conditional marketing authorization for KRAZATI as a targeted treatment option for adult patients with KRASG12C -mutated advanced non-small cell lung cancer (NSCLC) and disease progression after at least one prior systemic therapy.

repotrectinib

The European Medicines Agency (EMA) validated the marketing authorization application for repotrectinib as a treatment for ROS1 tyrosine kinase inhibitor (TKI)-naïve and -pretreated adult patients with ROS1-positive locally advanced or metastatic NSCLC and TKI naïve- and -pretreated adult and pediatric patients 12 years and older with NTRK-positive locally advanced or metastatic solid tumors. The application was based on the registrational Phase 1/2 TRIDENT-1 trial and CARE study. Application validation confirms the submission is complete and begins the EMA’s centralized review procedure.

Opdivo®

(nivolumab)

The FDA accepted the sBLA for Opdivo in combination with cisplatin-based chemotherapy as a first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma. The FDA granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of April 5, 2024.

In addition, the EMA validated the type II variation application for Opdivo in combination with cisplatin-based chemotherapy as a first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma. Application validation confirms the submission is complete and begins the EMA’s centralized review procedure.

The FDA’s sBLA acceptance and the EMA’s application validation are based on results from the Phase 3 CheckMate -901 trial.

AugtyroTM

(repotrectinib)

The FDA approved Augtyro, a TKI, for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC. The approval is based on results from the pivotal TRIDENT-1 study.

Clinical &

Research

Subcutaneous

nivolumab

Data from the Phase 3 CheckMate -67T trial, evaluating the subcutaneous formulation of Opdivo (nivolumab) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase compared to intravenous Opdivo in patients with advanced or metastatic clear cell renal cell carcinoma who have received prior systemic therapy, demonstrated noninferiority for the co-primary endpoints of Cavgd28 (time-averaged Opdivo serum concentration over 28 days) and Cminss (trough serum concentration at steady state) compared to intravenous Opdivo. In addition, subcutaneous nivolumab displayed noninferior objective response rate as assessed by Blinded Independent Central Review (BICR) versus intravenous Opdivo.

Opdivo

Four-year follow-up results from the CheckMate -9ER trial evaluating Opdivo in combination with CABOMETYX® (cabozantinib) vs. sunitinib in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC) continued to show superior progression-free survival (PFS) and objective response rates in patients treated with Opdivo plus CABOMETYX over sunitinib, regardless of risk classification based on International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) scores. Superior overall survival (OS) was also observed in patients treated with the combination.

Opdivo+Yervoy

Eight-year data from the Phase 3 CheckMate -214 trial evaluating Opdivo plus Yervoy versus sunitinib continued to demonstrate long-term survival results, reducing the risk of death by 28% in patients with previously untreated advanced or metastatic RCC, regardless of IMDC risk group. Patients treated with Opdivo plus Yervoy maintained superior survival and more durable response benefits compared to those who received sunitinib in both patients with intermediate- and poor-risk prognostic factors and across all randomized patients.

The Phase 3 CheckMate -8HW trial evaluating Opdivo plus Yervoy compared to investigator’s choice of chemotherapy as a first-line treatment for patients with microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer (MSI-H/dMMR mCRC) met the dual primary endpoint of PFS as assessed by BICR at a pre-specified interim analysis. The study is ongoing to assess the other dual primary endpoint of PFS per BICR in patients receiving Opdivo plus Yervoy compared to Opdivo alone, as well as secondary endpoints, including overall survival.

In addition, data from the Phase 3 CheckMate -8HW trial showed that the combination of Opdivo plus Yervoy reduced the risk of disease progression or death by 79% versus chemotherapy as a first-line treatment for patients with MSI-H/dMMR mCRC compared to chemotherapy. Opdivo plus Yervoy is the first dual immunotherapy regimen to demonstrate significant efficacy benefit compared to chemotherapy in MSI-H/dMMR mCRC.

OpdualagTM

(nivolumab and

relatlimab)

The Phase 3 RELATIVITY-123 trial evaluating the fixed-dose combination of nivolumab and relatlimab for the treatment of microsatellite stable metastatic colorectal cancer patients whose disease has progressed following at least one, but no more than four, prior lines of therapy for metastatic disease will be discontinued due to futility based on a planned analysis conducted by an independent data monitoring committee. It was determined that the trial was unlikely to meet its primary endpoints upon completion. The recommendation to stop the study was not based on safety concerns.

Hematology

Category

Asset

Milestone

Regulatory

Abecma®

(idecabtagene

vicleucel)

The Committee for Medicinal Products for Human Use (CHMP) of the EMA has recommended marketing authorization approval of Abecma for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. The CHMP recommendation will now be reviewed by the EC, which has the authority to approve medicines for the European Union.

Reblozyl®

(luspatercept-

aamt)

Japan’s Ministry of Health, Labour and Welfare (MHLW) granted manufacturing and marketing approval for Reblozyl 25 mg/75 mg injection for subcutaneous use indicated for myelodysplastic syndrome (MDS)-related anemia. The approval is based on the results of the global Phase 3 COMMANDS trial and the Phase 3 MEDALIST study, as well as a Japanese Phase 2 study (Study MDS-003) in red blood cell transfusion-independent low-risk MDS patients.

Breyanzi®

(lisocabtagene

maraleucel)

The FDA accepted sBLAs for Breyanzi to expand into new indications to include the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) and relapsed or refractory mantle cell lymphoma (MCL) after a Bruton tyrosine kinase inhibitor. The FDA granted both applications Priority Review and assigned a PDUFA goal date of May 23, 2024, for Breyanzi in relapsed or refractory FL and May 31, 2024, for Breyanzi in relapsed or refractory MCL.

In addition, Japan’s MHLW has also accepted the company’s supplemental New Drug Application (sNDA) for Breyanzi for the treatment of relapsed or refractory FL.

In relapsed or refractory FL, the applications for Breyanzi in the U.S. and Japan are based on results from the TRANSCEND FL study. In relapsed or refractory MCL, the application for Breyanzi in the U.S. is based on results from the MCL cohort of the TRANSCEND NHL 001 study.

Abecma

Japan’s MHLW granted manufacturing and marketing approval of the sNDA for an additional indication for Abecma for patients with relapsed or refractory multiple myeloma who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody. The approval is based on the interim analysis from the KarMMa-3 trial.

Breyanzi

The FDA accepted the sBLA for Breyanzi to expand its current indication to include the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who received a prior Bruton tyrosine kinase inhibitor and B-cell lymphoma 2 inhibitor. The FDA granted the application Priority Review and assigned a PDUFA goal date of March 14, 2024.

Clinical &

Research

Abecma

Results from the preplanned final progression-free survival (PFS) analysis of the pivotal Phase 3, open-label, global, randomized controlled KarMMa-3 trial demonstrated a significantly improved PFS maintained with Abecma compared to standard regimens, with a 51% reduction in the risk of disease progression or death.

Breyanzi

First disclosure of primary analysis results from the high-risk, second-line cohort of the Phase 2 TRANSCEND FL trial evaluating Breyanzi in patients with relapsed or refractory FL demonstrated 95.7% complete response for patients with high-risk relapsed or refractory FL treated in a second-line setting.

Reblozyl

Updated results from the primary analysis of the Phase 3 COMMANDS trial, comparing Reblozyl versus epoetin alfa for the treatment of anemia in erythropoiesis stimulating agent (ESA)-naïve patients with lower-risk myelodysplastic syndromes who may require red blood cell transfusions, confirmed positive outcome of the interim analysis with superior efficacy and durability compared to ESAs.

 

 

FULL YEAR FINANCIAL RESULTS

All comparisons are made versus the same period in 2022 unless otherwise stated.

  • Bristol Myers Squibb posted revenues of $45.0 billion, a decrease of 2%, both on a reported and when adjusted for foreign exchange basis, primarily due to lower sales of Revlimid, partially offset by higher sales of our new product portfolio and Opdivo.
  • U.S. revenues decreased 1%to$31.6 billion due to lower sales of Revlimid resulting from generic erosion and, as previously disclosed, an increase in the number of patients receiving free drug product for Revlimid, and to a lesser extent Pomalyst, from the Bristol Myers Squibb Patient Assistance Foundation, a separate and independent 501(c)(3) entity to which BMS donates products. This was partially offset by an increase in demand for Opdivo, Eliquis and new product portfolio.
  • International revenues decreased 6% to $13.5 billion, or 5% when adjusted for foreign exchange impacts, primarily due to lower sales of Revlimid and Eliquis, partially offset by an increase in demand for Opdivo and new product portfolio.
  • On a GAAP basis, gross margin decreased from 78.0% to 76.2% and on a non-GAAP basis, gross margin decreased from 78.8% to 76.6%, primarily due to product mix and lower hedge settlement gains.
  • On a GAAP and non-GAAP basis, marketing, selling and administrative expenses decreased 1% to $7.8 billion and $7.7 billion, respectively.
  • On a GAAP basis, research and development expenses decreased 2% to $9.3 billion. On a non-GAAP basis, research and development expenses decreased 1% to $9.1 billion.
  • On a GAAP and non-GAAP basis, Acquired IPRD increased 12% to $913 million. On a GAAP and non-GAAP basis, licensing income was $142 million during the year compared to $103 million in 2022.
  • On a GAAP basis, amortization of acquired intangible assets decreased 6% to $9.0 billion. The decrease was primarily due to the Abraxane marketed product right being fully amortized in the fourth quarter of 2022.
  • On a GAAP basis, effective tax rate changed from 17.7% to 4.7% primarily due to the receipt of a non-U.S. tax ruling regarding the deductibility of a statutory impairment and changes in income tax reserves, valuation allowances and IRS guidance regarding deductibility of certain non-U.S. research and development expenses. On a non-GAAP basis, the effective tax rate changed from 15.3% to 14.7%.
  • The company reported on a GAAP basis net earnings attributable to Bristol Myers Squibb of $8.0 billion, or $3.86 per share, compared to $6.3 billion, or $2.95 per share. In addition to the items above, the GAAP EPS was impacted by lower losses on equity investments as well as litigation and other settlement income in 2023. On a non-GAAP basis, net earnings attributable to Bristol Myers Squibb were $15.6 billion, or $7.51 per share, compared to $16.5 billion, or $7.70 per share. In addition to the non-GAAP drivers noted above, the non-GAAP EPS was impacted by higher royalty and investment income, as well as lower weighted-average common shares outstanding.

 

 

FULL YEAR PRODUCT REVENUE HIGHLIGHTS

($ amounts in millions)

Year Ended December 31,

2023

% Change from Year

Ended December 31,

2022

% Change from

Year Ended

December 31,

2022 Ex-F/X**

U.S.(c)

Int’l

WW(d)

U.S.(c)

Int’l

WW(d)

Int’l

WW(d)

In-Line Products

Eliquis

$

8,592

$

3,614

$

12,206

10%

(10)%

4%

(10)%

3%

Opdivo

5,283

3,726

9,009

10%

8%

9%

11%

10%

Orencia

2,754

847

3,601

4%

3%

4%

6%

5%

Pomalyst/Imnovid

2,357

1,084

3,441

(3)%

2%

(2)%

3%

(1)%

Yervoy

1,388

850

2,238

6%

3%

5%

5%

6%

Sprycel

1,446

484

1,930

(3)%

(28)%

(11)%

(25)%

(10)%

Mature and other products (a)

772

1,123

1,895

3%

(13)%

(7)%

(11)%

(6)%

Total In-Line Products

22,592

11,728

34,320

6%

(3)%

3%

(2)%

4%

New Product Portfolio

Reblozyl

811

197

1,008

37%

56%

41%

54%

40%

Opdualag

617

10

627

*

N/A

*

N/A

*

Abecma

358

114

472

21%

25%

22%

24%

21%

Zeposia

324

110

434

83%

51%

74%

47%

72%

Breyanzi

303

61

364

*

97%

100%

*

*

Camzyos

226

5

231

*

N/A

*

N/A

*

Sotyktu

157

13

170

*

N/A

*

N/A

*

Onureg

117

51

168

23%

76%

35%

72%

35%

Inrebic

74

36

110

7%

*

29%

*

29%

Augtyro

1

—

1

N/A

N/A

N/A

N/A

N/A

Total New Product Portfolio

2,988

597

3,585

80%

63%

77%

61%

76%

Total In-Line and New Product Portfolio

25,580

12,325

37,905

12%

(1)%

7%

—%

8%

Recent LOE Products (b)

Revlimid

5,266

831

6,097

(37)%

(49)%

(39)%

(47)%

(39)%

Abraxane

709

295

1,004

22%

28%

24%

39%

27%

Total Recent LOE Products

5,975

1,126

7,101

(33)%

(39)%

(34)%

(36)%

(34)%

Total Revenues

$

31,555

$

13,451

$

45,006

(1)%

(6)%

(2)%

(5)%

(2)%

 

Contacts

For more information, contact:
Media: media@bms.com
Investor Relations: investor.relations@bms.com

Read full story here

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Joby to install first electric air taxi charger in greater New York City region

SANTA CRUZ, Calif. — (BUSINESS WIRE) — Joby Aviation, Inc. (NYSE: JOBY), a company developing electric vertical take-off and landing (eVTOL) aircraft for commercial passenger service, on Sunday announced it has signed a definitive agreement with Helo Holdings, Inc. (“HHI”), to install the first air taxi charger in the greater New York City region at the company’s heliport in Kearny, New Jersey, located just a two minute flight from Manhattan.

 

The agreement, which provides Joby with an operational base for its electric air taxi in the NYC region, builds on the partnership already established between Joby and HHI in November 2023, when Kearny served as a temporary home base for Joby’s aircraft. Joby completed several flights at Kearny in preparation for the Company’s exhibition flight in New York City at an event hosted by the New York City Economic Development Corporation and Mayor Eric Adams. The city has committed to electrify the Downtown Manhattan Heliport to enable electric air taxi operations.

 

First opened in 2011, the Kearny heliport is the largest vertical-lift facility on the east coast with 27 parking spots for helicopters and plans to expand to 32. The heliport provides ground services as well as hangar space for maintenance operations to helicopter operators in the NYC region, one of the busiest low-altitude corridors in the world.

 

As part of the agreement, HHI will upgrade its electrical infrastructure to support the installation of Joby’s Global Electric Aviation Charging System (“GEACS”), designed to support the safe and efficient operation of all electric aircraft under development today, including Joby’s quiet, emissions-free air taxi.

 

“We’re pleased to expand our partnership with HHI as we prepare to install our GEACS charging system at Kearny Heliport. Kearny is expected to become the first heliport with an air taxi charger in the tri-state area and enable the launch of our quiet, emissions-free air taxi service in the greater New York City region,” said JoeBen Bevirt, Founder and CEO of Joby.

 

The GEACS charging interface is already in use at Joby’s flight test center in Marina, California and at Edwards Air Force Base. Joby recently announced a definitive agreement with Clay Lacy Aviation to install a charging system at John Wayne Airport (SNA) in Orange County, Calif.

 

Jeff Hyman, Founder and CEO of HHI, commented, “We continue to expand our footprint in Kearny in support of one of the busiest low-altitude corridors in the world, and we’re thrilled to partner with Joby, one of the leading developers of electric air taxis, to bring the next wave of quiet aircraft to residents of the tri-state area.”

 

In 2022, Joby announced a multi-year, multi-city commercial and operational partnership with Delta Air Lines to deliver seamless airport trips for its customers across several locations, including Los Angeles and New York City.

 

Joby’s air taxi is designed to carry a pilot and four passengers at speeds of up to 200 mph, offering high-speed mobility with a fraction of the noise produced by helicopters and no in-flight emissions.

 

About Joby

Joby Aviation, Inc. (NYSE: JOBY) is a California-based transportation company developing an all-electric, vertical take-off and landing air taxi which it intends to operate as part of a fast, quiet, and convenient service in cities around the world. To learn more, visit www.jobyaviation.com.

 

About HHI

Helo Holdings, Inc. has over twelve years of experience in heliport operations in the Northeast Corridor. In 2010, HHI opened the Kearny Heliport, located in Kearny, New Jersey, just two minutes’ flying time from Manhattan. Situated in the busiest helicopter corridor in the world, the facility offers tarmac parking spaces for 28 helicopters, 63,500 square feet of hangar space as well as office space, maintenance services, a pilot-friendly amenities lounge, and a 24,000-gallon fuel facility. HHI has owned, expanded and operated this vibrant heliport since its inception, carrying out day-to-day heliport operations, flight tracking, aviation facilities management, management of helicopter service providers, and aviation property management. Kearny Heliport has been awarded Heliport of the Year in 2013, 2019, 2022 & 2023 by ERHC.

 

Forward Looking Statements

This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including but not limited to, statements regarding the development and performance of our aircraft, the growth of our manufacturing capabilities, our regulatory outlook, progress and timing; our business plan, objectives, goals and market opportunity; plans for, and potential benefits of, our strategic partnerships; and the planned locations for our services. You can identify forward-looking statements by the fact that they do not relate strictly to historical or current facts. These statements may include words such as “anticipate”, “estimate”, “expect”, “project”, “plan”, “intend”, “believe”, “may”, “will”, “should”, “can have”, “likely” and other words and terms of similar meaning in connection with any discussion of the timing or nature of future operating or financial performance or other events. All forward looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including: our ability to launch our aerial ridesharing service and the growth of the urban air mobility market generally; our ability to produce aircraft that meet our performance expectations in the volumes and on the timelines that we project, and our ability to launch our service; the competitive environment in which we operate; our future capital needs; our ability to adequately protect and enforce our intellectual property rights; our ability to effectively respond to evolving regulations and standards relating to our aircraft; our reliance on third-party suppliers and service partners; uncertainties related to our estimates of the size of the market for our service and future revenue opportunities; and other important factors discussed in the section titled “Risk Factors” in our Annual Report on Form 10-K, filed with the Securities and Exchange Commission (the “SEC”) on March 1, 2023, and in future filings and other reports we file with or furnish to the SEC. Any such forward-looking statements represent management’s estimates and beliefs as of the date of this presentation. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.

Contacts

Joby Aviation

Investors:

investors@jobyaviation.com

Media:

press@jobyaviation.com

Categories
Business Digital - AI & Apps Government Lifestyle Perspectives Regulations & Security Technology

US Copyright Office in spotlight as it plans to release three key reports in 2024 about its  copyright law and AI positions

—  The office is reviewing how centuries-old laws should apply to artificial intelligence technology, with both content creators and tech giants arguing their cases.

 

 

Cecilia Kang / New York Times:

 

For decades, the Copyright Office has been a small and sleepy office within the Library of Congress. Each year, the agency’s 450 employees register roughly half a million copyrights, the ownership rights for creative works, based on a two-centuries-old law.

 

In recent months, however, the office has suddenly found itself in the spotlight. Lobbyists for Microsoft, Google, and the music and news industries have asked to meet with Shira Perlmutter, the register of copyrights, and her staff. Thousands of artists, musicians and tech executives have written to the agency, and hundreds have asked to speak at listening sessions hosted by the office.

“We are now finding ourselves the subject of a lot of attention from the broader general public,” said Shira Perlmutter, the director of the Copyright Office. Credit — Jared Soares for The New York Times

 

The attention stems from a first-of-its-kind review of copyright law that the Copyright Office is conducting in the age of artificial intelligence. The technology — which feeds off creative content — has upended traditional norms around copyright, which gives owners of books, movies and music the exclusive ability to distribute and copy their works.

 

The agency plans to put out three reports this year revealing its position on copyright law in relation to A.I. The reports are set to be hugely consequential, weighing heavily in courts as well as with lawmakers and regulators.

 

“We are now finding ourselves the subject of a lot of attention from the broader general public, so it is a very exciting and challenging time,” Ms. Perlmutter said.

 

The Copyright Office’s review has thrust it into the middle of a high-stakes clash between the tech and media industries over the value of intellectual property to train new A.I. models that are likely to ingest copyrighted books, news articles, songs, art and essays to generate writing or images. Since the 1790s, copyright law has protected works so an author or artist “may reap the fruits of his or her intellectual creativity,” the Copyright Office declares on its website.

 

That law is now a topic of hot debate. Authors, artists, media companies and others say the A.I. models are infringing on their copyrights. Tech companies say that they aren’t replicating the materials and that they consume data that is publicly available on the internet, practices that are fair use and within the bounds of the law. The fight has led to lawsuits, including one by The New York Times against the ChatGPT creator OpenAI and Microsoft. And copyright owners are pushing for officials to rein in the tech companies.

 

“What the Copyright Office is doing is a big deal because there are important principles of law and lots and lots of money involved,” said Rebecca Tushnet, a professor of copyright and intellectual property law at Harvard Law School. “At the end of the day, the issue is not whether these models will exist. It’s who will get paid.”

The Copyright Office, part of the Library of Congress, has in the past weighed in on how copyright would apply to technological innovations like records, the internet and streaming music.  Credit — Jared Soares for The New York Times

 

Congress created the Copyright Office in 1870 to register licenses for books, maps, essays and other creative works and store those works for the use of lawmakers at the Library of Congress. The first registration was given to the “Philadelphia Spelling Book,” a children’s language book.

When Ms. Perlmutter, a veteran copyright official and former intellectual property lawyer for Time Warner, was appointed to lead the Copyright Office in late 2020, she promised to bring the office into the modern era by focusing on big tech trends. She took inspiration from previous leaders, who dealt with technological innovations including the camera, records, Xerox machines, the internet and streaming music, all of which required the office to weigh in on how copyright would apply and advise Congress on proposed updates to the law.

 

Right away, A.I. became a hot topic. Stephen Thaler, a computer scientist, tried to register an A.I.-generated art piece for a copyright by submitting an application on the Copyright Office’s website. In 2019, the office rejected his first attempt to register the piece, a pixelated scene of train tracks running through a tunnel overgrown with brush and flowers called “A Recent Entrance to Paradise.” In February 2022, Ms. Perlmutter declined his second attempt to register the piece on the same grounds: Copyrights were given only to original works created by humans.

 

The decision — a first on an A.I.-produced work — set an important precedent. Artists and lawmakers flooded Ms. Perlmutter’s office with emails and phone calls asking her to also intervene in the way A.I. companies were using copyrighted material to train their systems.

 

In August, she opened the formal review of A.I. and copyright law. The office said it would examine whether the use of intellectual property to train A.I. models violated the law and would look more deeply into whether machine-generated works could be eligible for copyright protections. The office said it would also review how A.I. tools were creating content that used the names, images and likenesses of individuals without their consent or compensation.

 

“The attention on A.I. is intense,” Ms. Perlmutter said in an interview. “The current generative A.I. systems raise a lot of complicated copyright issues — some have called them existential — that really require us to start grappling with fundamental questions about the nature and value of human creativity.”

 

The interest in the office’s review was overwhelming. The office solicited public comments on the topic and received more than 10,000 responses on a form on its website. A typical policy review gets no more than 20 comments, the office said.

 

Tech companies argued in comments on the website that the way their models ingested creative content was innovative and legal. The venture capital firm Andreessen Horowitz, which has several investments in A.I. start-ups, warned in its comments that any slowdown for A.I. companies in consuming content “would upset at least a decade’s worth of investment-backed expectations that were premised on the current understanding of the scope of copyright protection in this country.”

 

OpenAI, Microsoft, Meta (Facebook’s parent) and Google are currently relying on a 2015 court decision in a case filed by the Authors Guild.

 

The guild sued Google in 2005 for scanning books to use in excerpts in its search engine results and to share with libraries. A court ruled that Google had not violated copyright law. It said that the scanning of entire books was permissible because Google didn’t make the full book available and that it was “transformative” use of copyrighted material. Google relied on an exemption to copyright law known as “fair use” that allows limited replication of copyrighted material for things like criticism, parody or other transformational uses.

 

Google, Meta and the A.I. start-up Anthropic all echoed arguments from that case in their comments to the Copyright Office, including that A.I. copies the information to analyze data, not repurpose it for creative works.

 

Authors, musicians and the media industry argued that by taking their content without permission or licensing payments, the A.I. companies were robbing them of their livelihoods.

 

“The absence of consent and compensation in this process is theft,” Justine Bateman, the “Family Ties” actress and author, wrote in comments to the Copyright Office.

 

News Corp, which publishes The Wall Street Journal and The New York Post, implored the office to “not lose sight of this simple truth: Protecting content creators is one of copyright law’s core missions.” (The Times also submitted a comment).

 

Ms. Perlmutter said she and a staff of about two dozen copyright lawyers were going through each comment filed to the office.

 

Still, the office may not offer clear-cut views that will satisfy either the tech companies or creative people.

 

“As technology gets more and more sophisticated, the challenges are exponentially more difficult and the risks and rewards are exponentially greater,” Ms. Perlmutter said.

 

 

 

Read more

 

 

— Techmeme

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Align appoints Vinod Paul as president of Align Managed Services

Vinod Paul to Lead Strategic Direction and Expansion of Align’s Managed Services Portfolio

NEW YORK — (BUSINESS WIRE) — #ITservices — Align, the leading global provider of technology infrastructure solutions and Managed IT Services, announces the appointment of Vinod Paul as President of Align Managed Services, effective immediately.

 

In his new role, Vinod will continue to drive the strategic direction, expansion, and profitability of Align’s managed services portfolio, including cloud solutions, cybersecurity, and tailored products designed for the financial services community. Vinod’s vision and leadership will be instrumental in shaping the company’s growth strategy, while overseeing client services, technology and thought leadership in both the financial services and Managed Services industries.

 

Vinod joined Align in 2017 and has since served as Chief Operating Officer, before being appointed as President. Under his leadership, Align has expanded its global customer base and broadened its managed services offerings in the financial services sector. In 2023, Align was named MSP of the Year by Channel Futures and was ranked 60th in the global MSP 501 list. Other accolades include Best Cloud Services Provider by Hedgeweek, CRN’s Triple Crown Award by Channel Co. and more – click here to view our full list of awards.

 

Vinod has more than 20 years of experience in the Managed Services industry, with a proven track record of delivering innovative and customer-centric solutions. Prior to Align, he held senior leadership roles at several global IT firms, including ECI, IBM Global Services, Lucent Technologies, and Tyco Submarine Systems. In 2022, he received the honor of being included in Channel Futures’ Most Influential MSP leaders of 2022 List. Vinod was also recognized as a 2023 Honoree by Help for Children (HFC). Founded with a mission to make a profound difference in the lives of children in need, HFC is a renowned charitable organization dedicated to the prevention and treatment of child abuse for youth across the globe.

 

“Vinod is a visionary leader who has transformed our managed services business and delivered exceptional results for our customers and the broader financial services industry,” said Jim Dooling, CEO and President of Align Communications.

 

“He has a deep understanding of the market dynamics, customer needs, and technology trends that impact our industry. I am confident he will continue to drive growth and innovation for our managed services division and for Align.”

 

“I am honored and excited to take on this new role and lead our talented and dedicated team of managed services professionals,” said Vinod.

 

“Align is renowned for delivering top-notch and cost-efficient IT solutions and managed services to clients within the financial services sector. I am enthusiastic about actively contributing to our continued success, enhancing value for our customers, partners, and team members alike. Our dedication is to cultivate enduring partnerships with our clients, and I am excited to collaborate with our leaders to ensure an unparalleled client experience as a leading managed services provider.”

 

About Align

Align is a premier global provider of technology infrastructure solutions. For over 36 years, leading firms worldwide have relied on Align to guide them through IT challenges, delivering complete, secure solutions for business change and growth. Align is headquartered in Dallas, Texas and has offices in New York City, London, Chicago, San Francisco, Arizona, New Jersey, Texas and Virginia.

 

To learn more about Align Managed Services, visit our website here: https://www.align.com/managed-services and follow Align on LinkedIn and at @AlignITAdvisor on Twitter.

Contacts

Media
Ashley Holbrook
Director of Marketing, Align

aholbrook@align.com

Categories
Business Digital - AI & Apps International & World Regulations & Security Technology

Apple’s proposed App Store, iOS changes seek to retain some iOS control but still regard the  EU’s DMA letter

John Gruber / Daring Fireball:

 

 

—  On Saturday, Apple announced a broad, wide-ranging, and complex set of new policies establishing their intended compliance with the European Union’s Digital Markets Act, which comes into effect March 7.

 

There is a lot to remark upon and numerous remaining questions, but my favorite take was from Sebastiaan de With on Twitter/X, the day before any of this was announced.

 

After quipping “Oh god please no” to a screenshot of the phrase “Spotify also wants to roll out alternate app stores”, de With had this conversation:

de With:

The EU is once again solving absolutely no problems and making everything worse in tech. I gotta say, they are if anything highly consistent.

“Anton”:

Overly powerful, rent-seeking gatekeepers seem like a problem.

de With:

I love that I can’t tell if you are talking about the EU or Apple in this case.

My second-favorite take, from that same thread, was this from Max Rovensky:

DMA is not pro-consumer.

It’s anti-big-business.

Those tend to coincide sometimes, which makes it an easy sell for the general public, but do actually read the DMA, it’s quite interesting.

 

I’d go slightly further and describe the DMA as anti-U.S.-big-business, because as far as I can tell, nothing in the DMA adversely affects or even annoys any European tech companies. There are aspects of it that seem written specifically for Spotify, in fact.

 

But Rovensky’s framing captures the dichotomy. Anti-big-business regulation and pro-consumer results often do go hand-in-hand, but the DMA exposes the fissures. I do not think the DMA is going to change much, if anything at all, for the better for iOS users in the E.U. (Or for non-iOS users in the EU, for that matter.) And much like the GDPR’s website cookie regulations, I think if it has any practical effect, it’ll be to make things worse for users. Whether these options are better for developers seems less clear.

 

I’ve often said that Apple’s priorities are consistent: Apple’s own needs first, users second, developers third. The European Commission’s priorities put developers first, users second, and “gatekeepers” a distant third. The DMA prescribes not a win-win-win framework, but a win-win-lose one.

 

Apple is proud, stubborn, arrogant, controlling, and convinced it has the best interests of its customers in mind.

 

The European Commission is proud, stubborn, arrogant, controlling, and convinced it has the best interests of its citizens in mind.

 

Ever since this collision over the DMA seemed inevitable, starting about two years ago, I’ve been trying to imagine how it would turn out. And each time, I start by asking: Which side is smarter? My money has been on Apple. Yesterday’s announcements, I think, show why.

APPLE’S PROPOSED CHANGES

 

It’s really hard to summarize everything Apple announced yesterday, but I’ll try. Start with the main Apple Newsroom press release, “Apple Announces Changes to iOS, Safari, and the App Store in the European Union”:

“The changes we’re announcing today comply with the Digital Markets Act’s requirements in the European Union, while helping to protect EU users from the unavoidable increased privacy and security threats this regulation brings. Our priority remains creating the best, most secure possible experience for our users in the EU and around the world,” said Phil Schiller, Apple Fellow. “Developers can now learn about the new tools and terms available for alternative app distribution and alternative payment processing, new capabilities for alternative browser engines and contactless payments, and more. Importantly, developers can choose to remain on the same business terms in place today if they prefer.”

 

Schiller is the only Apple executive quoted in the press release, and to my ear, his writing hand is all over the entire announcement. Apple was quite clear before the DMA was put into law that they considered mandatory sideloading on iOS a bad idea for users, and their announcement yesterday doesn’t back down an inch from still declaring it a bad idea.

 

Apple has also argued, consistently, that they seek to monetize third-party development for the iOS platform, and that being forced to change from their current system — (a) all apps must come from the App Store; (b) developers never pay anything for the distribution of free apps; (c) paid apps and in-app-purchases for digital content consumed in-app must go through Apple’s In-App Payments system that automates Apple’s 30/15 percent commissions — would greatly complicate how they monetize the platform. And now Apple has revealed a greatly complicated set of rules and policies for iPhone apps in the EU.

 

MG Siegler has a great — and fun — post dissecting Apple’s press release line-by-line. Siegler concludes:

I’m honestly not sure I can recall a press release dripping with such disdain. Apple may even have a point in many of the points above, but the framing of it would just seem to ensure that Apple is going to continue to be at war with the EU over all of this and now undoubtedly more. Typically, if you’re going to make some changes and consider the matter closed, you don’t do so while emphatically shoving your middle fingers in the air.

 

Some of these changes do seem good and useful, but most simply seem like convoluted changes to ensure the status quo actually doesn’t change much, if at all. Just remember that, “importantly, developers can choose to remain on the same business terms in place today if they prefer.” What do you think Apple prefers?

The puzzle Apple attempted to solve was creating a framework of new policies — and over 600 new developer APIs to enable those policies — to comply with the DMA, while keeping the path of least resistance and risk for developers the status quo: Apple’s own App Store as it is.

 

So the first option for developers is to do nothing — to stay in Apple’s App Store, exclusively, under the existing terms. (Apple made a few announcements yesterday that are effective worldwide, not merely in the EU, such as changes regarding the rules for streaming game services, mini-games, and mini-apps. For the sake of brevity — well, attempted brevity — I’m focusing on E.U.-specific changes related to DMA compliance.)

 

One point of confusion is that some aspects of Apple’s proposed DMA compliance apply to the App Store across all platforms (iPhone, iPad, Mac, TV, Watch, and soon, Vision), but other aspects are specific to the iOS platform — which is to say, only the iPhone. Third-party app marketplaces1 and web browsers using non-WebKit rendering engines are only available on iOS specifically, meaning they are iPhone-only,2 and not available for iPadOS. Apple’s main press release yesterday breaks out iOS changes and App Store changes separately, but on my first read did not make clear that the iOS changes did not apply to iPadOS.3

 

 

Here’s my summary of the options available to developers in the EU, under Apple’s proposal:

  1. Stay in App Store under the current (pre-DMA) rules, exclusively. Developers that take this option:
    • Are not permitted to use any of the new business termsavailable in the EU, but new iOS platform options for the EU, such as alternate browser engines, are allowed. (Because they are required to be allowed.)
    • Because nothing business-related changes under this option, the existing worldwide rules apply for paid apps, subscriptions, and in-app purchases (IAP), including the 30/15 percent commission to Apple and a requirement that apps exclusively use Apple’s App Store payments system.
    • The Core Technology Fee (CTF) is not collected, because the business terms haven’t changed. (See below re: the CTF.)
  2. Opt in to the new EU rules (all sub-options available under this choice require paying the Core Technology Fee for each app with over 1 million downloads in the EU):
    • After opting in to the new EU rules, developers can choose to remain in the App Store, and:
      • Use Apple’s App Store payments system: 20/13 percent commission + CTF paid to Apple automatically.
      • Use a custom in-app payments system (e.g. Stripe): 17/10 percent commission + CTF paid to Apple.
      • Use external links from inside apps to the web for payments and subscriptions: 17/10 percent + CTF paid to Apple.
      • The latter two options — using custom payment processing and/or external links to the web — are similar to the announced-last-week External Payment Link entitlement policy, regarding the developer’s obligation to track these payments, report sales to Apple monthly, and submit to audits by Apple to ensure compliance.
    • Distribute apps in one or more third-party marketplaces:
      • No option to use Apple’s App Store payment processing, because the apps aren’t coming from the App Store.
      • The only money due to Apple is the Core Technology Fee — there is no commission percentage on in-app transactions or links to the web.

 

Under option (2) — the catch-all for opting in to the new rules available in the EU — the sub-options are not mutually exclusive. Developers that opt in to the new EU rules can have (or keep) apps in the App Store and distribute those same apps, or different apps, via third-party app marketplaces. Or they can stay in the App Store exclusively (under the new business terms, with lower commissions but also the CTF), or they can distribute exclusively via app marketplaces.

 

Only options (1) and (2) are exclusive. However, once a developer opts in to the new EU rules, that decision is irrevocable. Quoting from the Q&A section of Apple’s “Update on Apps Distributed in the European Union” document:

Developers who adopt the new business terms at any time will not be able to switch back to Apple’s existing business terms for their EU apps. Apple will continue to give developers advance notice of changes to our terms, so they can make informed choices about their businesses moving forward.

(That entire FAQ section is a good summary and worth reading.)

 

THE CORE TECHNOLOGY FEE

Apple’s description of the CTF:

The Core Technology Fee (CTF) reflects Apple’s investment in the tools, technology, and services that enable developers to build and share their apps with Apple users. That includes more than 250,000 APIs, TestFlight, Xcode, and so much more. These tools create a lot of value for developers, whether or not they share their apps on the App Store.

 

The CTF only applies to developers who adopt the new terms for alternative distribution and payment processing — and whose apps reach exceptional scale. With membership in the Apple Developer Program, eligible developers on the new business terms get a free one million first annual installs per year for each of their apps in the EU. See terms for more details. Under the new business terms for EU apps, Apple estimates that less than 1% of developers would pay a Core Technology Fee.

 

Apple’s description is clear on the following point, but it’s worth reiterating: the CTF only applies to downloads above 1 million, like a marginal tax rate. So a developer whose app goes from 1,000,000 EU user downloads to 1,000,001 will only owe Apple €0.50 in Core Technology Fees. The CTF is recurring each year however, and updates count as downloads. Installing the same app on multiple devices does not count as multiple installations though.4 The CTF is calculated per user, per app, per year. (Apple has a CTF calculatordevelopers can use to game scenarios of prices, distribution method, and download counts.)

 

In plain language, the DMA demands that Apple unbundle its monetization for the App Store from its monetization of the iOS platform. Apple’s existing, purely commission-based, monetization for iOS apps implicitly bundles together the value provided from the App Store and iOS.

 

So under option (1) — where developers choose the existing rules for App Store distribution, including App Store exclusivity — nothing changes and Apple collects its 30/15 percent commissions from App Store transactions.

 

But under option (2) — where developers opt in to the new EU rules — Apple’s monetization for the App Store is severed from its monetization for the iOS platform itself. That’s why the commission fees under the new EU rules are reduced to 20/13 percent for apps distributed through the App Store that use the App Store payment system, and 17/10 percent for apps distributed through the App Store that use custom payment processing. Effectively, Apple is saying that their fair share of App Store distribution is 17/10 percent, and that Apple’s own App Store payment processing is worth an additional 3 percent. (3 percent is almost indisputably a fair estimate for the cost of payment processing alone.)

 

And, that’s why apps distributed outside the App Store will only pay Apple the CTF, with no commission on sales. The commissions under the new EU rules are only for the App Store, so apps from marketplaces don’t pay them. The Core Technology Fee is how Apple proposes monetizing the value provided by iOS itself.

 

All developers who opt in to the new EU rules are subject to the CTF. No developers who remain in the App Store under existing policies are subject to the CTF.

 

MARKETPLACE APPS ARE THE ONLY DISTRIBUTION OUTSIDE THE APP STORE

Third-party marketplace apps are the only way for developers to distribute apps in the EU outside the App Store. Apple’s proposal has no option for direct downloads of apps from developer websites. Apple has rules for who can become an app marketplace. You have to be a company, not an individual. You must “provide Apple a stand-by letter of credit from an A-rated (or equivalent by S&P, Fitch, or Moody’s) financial Institution of €1,000,000 to establish adequate financial means in order to guarantee support for your developers and users.” And more. In short, the qualifications aren’t trivial, but nor are they overly complicated.

 

But marketplace apps must be real “stores”. A marketplace can decide to exclusively distribute apps from a certain category — like games — but must be open to submissions from any developer in that same category. Company XYZ can’t create a marketplace that only distributes XYZ’s own apps. That’s not a proper category. Nor would Apple consider to be a proper category something like, say, “Apps from companies founded by Harvard dropouts whose origins were depicted in fun movies by Aaron Sorkin.”

 

One key restriction for developers who wish to distribute through multiple stores (including Apple’s App Store): an installation from one store cannot overwrite an existing installation of the same app from another store. The user must manually delete the installation from the old store first, then re-install the app from the other store. Apple claims — reasonably, perhaps — that this restriction is because they don’t know whether a fresh installation from a different store will preserve the data from the app installed via the previous store.

 

But this also means that if, say, Meta starts distributing their apps through a third-party marketplace (perhaps their own Meta Store), and wishes to encourage iOS users to switch from App Store installations to installations from the Meta Store, each user who does so must delete their existing installations of Meta’s apps before installing the new ones.

 

Third-party marketplace apps — the actual app store apps — will not be permitted in Apple’s App Store. To install a marketplace app — and third-party app marketplaces will be apps themselves — users must go to the marketplace app’s website. Safari (and other web browsers that adopt new APIs) will offer to install marketplace apps after confirmation from the user that they really want to install it. That confirmation scaresheet and the subsequent installation is provided by the system.

 

Part of what makes the DMA a terrible law (in this writer’s estimation) is its ambiguity and inscrutable language. It’s completely unclear whether Apple’s proposal to only allow distribution of apps outside the App Store through marketplace apps is compliant. Many proponents of the DMA have been under the conviction that the DMA mandates gatekeeper platforms like iOS to permit direct downloads of apps from the web (like on PCs and Macs). Here’s Article 6, Section 4 of the DMA, boldface all-caps emphasis added:

4. The gatekeeper shall allow and technically enable the installation and effective use of third-party software applications OR software application stores using, or interoperating with, its operating system and allow those software applications OR software application stores to be accessed by means other than the relevant core platform services of that gatekeeper. The gatekeeper shall, where applicable, not prevent the downloaded third-party software applications OR software application stores from prompting end users to decide whether they want to set that downloaded software application OR software application store as their default. The gatekeeper shall technically enable end users who decide to set that downloaded software application OR software application store as their default to carry out that change easily.

 

By Apple’s interpretation, all of those or’s would be and/or’s or and’s if the DMA demanded that iOS support both third-party marketplaces and direct installation of individual apps and games. See below regarding the uncertainty of this interpretation.

 

 

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— Techmeme

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Flipkart’s co-founder Binny Bansal resigns after selling his entire stake in the company

—  Flipkart co-founder Binny Bansal has resigned from the e-commerce group’s board

 

 

Manish Singh / TechCrunch:

 

 

Binny Bansal, Flipkart co-founder, and Sachin Bansal, the Bengaluru-headquartered startup’s other co-founder, experienced a scuffle with the investors, and Binny has resigned from the e-commerce group’s board, the two said Saturday.

 

Binny Bansal, who reserved the rights to stay on Flipkart’s board, (which was acquired by Walmart in 2018), as long as he preferred, instead opted to leave. He cited conflict of interest with his new venture as the reason for the move.

 

Bansal launched OppDoor, a cross-border e-commerce startup, late last year. OppDoor offers end-to-end solutions — including market entry analysis, demand mapping, inventory management, cross-border logistics and taxation assistance — to businesses, according to its website.

 

The move also follows Bansal selling his entire stake in Flipkart, which was acquired by Walmart in 2018 for $16 billion, in recent years ahead of the e-commerce group’s much-awaited IPO, which is now slated for 2025. Bansal — who is also on the board of PhonePe, a position he is maintaining — has become a prolific investor in recent years, backing a number of startups including PhonePe.

 

“I am proud of the Flipkart Group’s achievements over the past 16 years. Flipkart is in a robust position, with a strong leadership team and a clear path forward, and with this confidence, I have decided to step aside, knowing the company is in capable hands,” Bansal said in a statement.

 

After leaving Flipkart, Sachin Bansal founded Navi, a financial services firm that is looking to go public. In 2022, Navi filed the paperworks for its initial public offering, but deterred the plan after the market conditions worsened.

 

“Flipkart is the outcome of a great idea and a lot of hard work, built by teams committed to transforming how India shops,” Flipkart Group chief executive Kalyan Krishnamurthy said in a statement Saturday. “We wish Binny the best as he embarks on his next venture and thank him for the deep impact he has enabled for the Indian retail ecosystem.”

 

 

 

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— Techmeme