Down syndrome treatments – Nova Scotia Down Syndrome Society Fri, 03 Jun 2022 01:43:27 +0000 en-US hourly 1 Down syndrome treatments – Nova Scotia Down Syndrome Society 32 32 How to get a Covid vaccine if you’re 16 or 17 Fri, 06 Aug 2021 11:12:03 +0000 More than one million children and young people can now receive the Covid vaccine in the final stage of the NHS vaccination program. The NHS has worked to quickly expand the program to 16 and 17 year olds, the country’s most vulnerable children and those living with vulnerable adults following changes to the Joint Committee’s […]]]>

More than one million children and young people can now receive the Covid vaccine in the final stage of the NHS vaccination program.

The NHS has worked to quickly expand the program to 16 and 17 year olds, the country’s most vulnerable children and those living with vulnerable adults following changes to the Joint Committee’s guidelines on immunization and vaccination (JCVI).

All 16 and 17 year olds will be offered a jab dose of the vaccine, according to new guidelines released by the JCVI earlier this week.

As a first step, they must wait to be contacted by their GP to arrange an appointment, although walk-in services will soon be available for anyone aged 16 and over.

While children and young people can contract the coronavirus, there are fewer cases compared to adults and the symptoms are usually mild.

Dr Nikki Kanani, NHS Medical Director for Primary Care and Assistant ORS for Immunization Program, said: ‘NHS staff have delivered 70 million Covid-19 vaccines across England in just over seven months, providing protection against the coronavirus to more than 39 million people and saving thousands of lives.

‘The NHS has also been working hard to implement the JCVI guidelines as quickly as possible and I am happy to say that a million children and young people will now be able to get vaccinated, protecting themselves and their family and friends .

“The Covid-19 vaccine is safe and effective and I urge any eligible person of any age to come forward and accept the offer. ”

Children between the ages of 12 and 15 who are clinically vulnerable to Covid, or who live with adults who are at increased risk of serious illness from the virus, will also be contacted by the NHS and asked for their vaccine in the coming weeks.

Eligible individuals include people with Down syndrome or who are undergoing multiple cancer treatments, who have had an organ or bone marrow transplant, or who are on the Learning Disabilities Registry.

The Covid-19 vaccine will also be offered to children 12 years and older who live with an immunocompromised person, such as those who are receiving chemotherapy or who have had a transplant.

Children and youth now eligible will be offered the Pfizer Covid-19 vaccine.

More than 70 million vaccines have been issued since the NHS in England made history when Margaret Keenan received the first vaccine outside of a clinical trial in Coventry in December 2020.

Anyone aged 18 or over is eligible for a Covid-19 jab via or by visiting the nearest walk-in center, which in Cornwall includes Stithians Showground and the Royal Cornwall Showground near Wadebridge.

Second doses are available for people who received their first dose eight weeks ago, as directed by JCVI.

Anyone who cannot connect can call the service on 119 to reserve their jab.

He is the chiropractor of the Olympic athletics stars Tue, 03 Aug 2021 10:44:22 +0000 For his part, Ball doesn’t seem to have much trouble keeping a step back. “It’s always funny to me because they tell me ‘Ugh, my Achilles hurts’,” Ball said. “OK, well, they cut off part of my eye last week. Everyone has their problems. Gravity is the enemy Ball grew up in Davenport, Iowa, where […]]]>

For his part, Ball doesn’t seem to have much trouble keeping a step back.

“It’s always funny to me because they tell me ‘Ugh, my Achilles hurts’,” Ball said. “OK, well, they cut off part of my eye last week. Everyone has their problems.

Ball grew up in Davenport, Iowa, where his father was a football coach and his mother, Jan, was a chiropractor. Tim O’Neill, one of his closest friends, recalled that Ball was smart and athletic – the fastest kid in the neighborhood. Ball thought he would play college basketball, until his 3-point shot evaporated when he was in high school.

“I couldn’t see the hoop,” he said.

Diagnosed with keratoconus, gradual thinning and bulging of the cornea, Ball gave up his wayward jump shot to arizona state race track, where he learned the hard way what it’s like to run with nagging injuries. Before his final year, he left school due to a family emergency and ended up studying for his chiropractic degree in his hometown.

“I wanted to be really good at something,” Ball said, “and when I found out about that I probably got a little bit obsessive.”

He returned to Arizona and opened his own practice, seeing ordinary people with regular problems. His favorite patient, he said, was an elderly woman with carpal tunnel syndrome who knitted a blanket for her.

His career changed as the 2004 Olympics approached, when he met Patrick Nduwimana, an NCAA champion within half a mile while at the University of Arizona. Nduwimana, who was recovering from ankle surgery, said a friend recommended Ball as a practitioner of “active release therapy,” a form of manual chiropractic treatment. For about an hour, Ball applied pressure using his hands on Nduwimana’s ankle to release the tension.

Gilead Sciences (GILD) Q2 2021 Earnings Call Transcript Fri, 30 Jul 2021 15:22:08 +0000 Image source: The Motley Fool. Gilead Sciences (NASDAQ:GILD)Q2 2021 Earnings CallJul 29, 2021, 4:30 p.m. ET Contents: Prepared Remarks Questions and Answers Call Participants Prepared Remarks: Operator Good day, and thank you for standing by. Welcome to the Gilead Sciences second-quarter 2021 earnings conference call. [Operator instructions] Please be advised that today’s conference is being recorded. [Operator […]]]>

Image source: The Motley Fool.

Gilead Sciences (NASDAQ:GILD)
Q2 2021 Earnings Call
Jul 29, 2021, 4:30 p.m. ET


  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:


Good day, and thank you for standing by. Welcome to the Gilead Sciences second-quarter 2021 earnings conference call. [Operator instructions] Please be advised that today’s conference is being recorded. [Operator instructions] I would now like to hand the conference over to your speaker today, Jacquie Ross, VP, investor relations.

Please go ahead.

Jacquie RossVice President, Investor Relations

Thank you, Joelle, and good afternoon, everyone. Just after market close today, we issued a press release with earnings results for the second quarter of 2021. The press release, slides and supplementary data are available on the Investors section of our website at The speakers on today’s call will be our chairman and chief executive officer, Daniel O’Day, our chief commercial officer, Johanna Mercier; our chief medical officer, Merdad Parsey; and our chief financial officer, Andrew Dickinson.

After that, we’ll open up the call to Q&A, where the team will be joined by Christi Shaw, the chief executive officer of Kite. Before we get started, let me remind you that we will be making forward-looking statements, including those related to the impact of the COVID-19 pandemic on Gilead’s business; financial condition and results of operations; plans and expectations with respect to products; product candidates; corporate strategy; financial projections and the use of capital; and 2021 financial guidance, all of which involve certain assumptions, risks and uncertainties that are beyond our control and could cause actual results to differ materially from these statements. A description of these risks can be found in the earnings press release and our latest SEC disclosure documents. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

Non-GAAP financial measures will be used to help you understand the company’s underlying business performance. The GAAP to non-GAAP reconciliations are provided in the earnings press release, in our supplementary data sheet, as well as on the Gilead website. I will now turn the call over to Dan.

Daniel O’DayChairman and Chief Executive Officer

Thank you, Jacquie, and good afternoon, everyone. Thanks for taking the time to join us here today. We’re pleased to provide you with an update on our second quarter, where we delivered solid financial performance and significant progress on our increasingly diverse pipeline. 2021 is an important year for our pipeline, and we’re very encouraged by the milestones we’ve achieved for therapies that are potentially transformative for Gilead and for patients.

All of this reinforces our confidence in our strategic direction. I want to take this opportunity to thank our global community of Gilead and Kite employees, who consistently go above and beyond to drive progress with resilience and dedication. Different parts of the world are riding the ebb and flow of COVID-19 cases at various times. And while the vaccines give us hope and optimism, we are still very much living with the pandemic.

Remdesivir continues to play an important role in fighting the virus and has now been used to treat an estimated seven million hospitalized patients worldwide. Turning to the main highlights of the quarter on Slide 4, the second quarter was a solid quarter overall. Veklury sales of $829 million were once again higher than anticipated, offsetting the lingering impact of the pandemic, particularly on HIV treatment. In light of this pandemic impact, Biktarvy’s performance is quite encouraging, revenue for the quarter was USD 2 billion, up 24% or $390 million from the same quarter last year.

This more than offset the $322 million headwind associated with the impact of the Truvada and Atripla LOEs. Much of that headwind is now, of course, behind us. Overall, our share of the HIV treatment market held steady quarter over quarter, and our PrEP share remains steady even with generic entries. These dynamics give us confidence that the underlying demand for our HIV products remains strong and positions us well for growth as the overall HIV market recovery gains momentum.

Moving to our clinical pipeline, 2021 is a catalyst-heavy year for Gilead, and we’ve delivered all of our key first-half pipeline commitments. Among other milestones, we shared top-line data from the highly anticipated ZUMA-7 trial, where Yescarta improved event-free survival for second-line large B-cell lymphoma or LBCL patients by 60% compared to the standard of care. This is truly a landmark trial, the first and largest reported Phase 3 trial readout that demonstrates the efficacy and safety of cell therapy, and we are excited by the opportunity to bring the potential benefits of cell therapy to patients in earlier lines. We shared positive Phase 3 data from MYR301, which will help support our anticipated BLA filing for Hepcludex for HDV in the U.S.

later this year, and we submitted our NDA for use of lenacapavir in the heavily treatment-experienced population with multidrug resistance. This filing was based on data from the Phase 1/2 CAPELLA study presented earlier this month. We also shared strong lenacapavir data from the Phase 2 CALIBRATE study in HIV treatment, which will be used to inform our broader lenacapavir efforts. Our partner, Arcus provided an interim update from ARC-7 that supports the continuation of both ARC-7 and ARC-10 trials for their anti-TIGIT candidate, domvanalimab.

Lastly, on Slide 4, we’re beginning to see the positive impact of our strategy, which we introduced early last year. The business is diversified across indications and therapies. In particular, we are seeing Cell Therapy and Trodelvy contribute to growth and expect they will be key growth drivers for Gilead. While we build out the oncology business, we remain focused and committed on ensuring the long-term competitive positioning of our virology portfolio.

Next, on Slide 5, we highlighted our pipeline execution so far this year. And I’d like to thank all those who helped us to deliver on this ambitious agenda, including our employees, the people who participated in the studies, our partners and the study investigators. As we look ahead to the rest of the year, our target milestones include a progression-free survival or PFS readout in our event-driven Phase 3 TROPiCS-02 study evaluating Trodelvy in hormone receptor HER2-negative metastatic breast cancer. A Phase Ib readout for magrolimab and myelodysplastic syndrome or MDS.

Depending on the data, timing and results, this could result in a BLA submission for accelerated approval and initiation of the potential Phase 3 lenacapavir and islatravir long-acting oral combination. As you know, this is in collaboration with Merck and the development and formulation work remains on track. We look forward to updating you next quarter about the additional milestone progress. We understand the continued strong and consistent pipeline execution is critical to the extending the virology business and expanding further into oncology.

We believe our current and pipeline therapies can address significant unmet medical needs. We are very encouraged by the progress Gilead and Kite are making. We are well on our way in our journey to expand and diversify into new therapeutic areas and we are already seeing the evolution of both our pipeline and commercial portfolio. With that, I’ll hand over to Johanna, who will share an update on our commercial performance for the second quarter.

Johanna MercierChief Commercial Officer

Thanks, Dan, and good afternoon, everyone. Starting on Slide 7, total product sales of $6.2 billion were up 21% year over year, primarily reflecting Veklury, which was not a contributor to revenue in the second quarter of 2020. On Slide 8, Veklury second-quarter revenues of $829 million declined sequentially, reflecting the impact of higher vaccination rates and lower infection and hospitalization in many regions. While hospitalizations trended lower in the second quarter, Veklury remains the therapy of choice in three out of five patients hospitalized with COVID-19.

We estimate that since the launch in May 2020, roughly 7 million patients globally have been treated with remdesivir. It’s truly remarkable and encouraging to see how remdesivir continues to play such a key role in fighting this global pandemic. Excluding Veklury, total product sales of $5.3 billion were up 5% year over year. We saw growth in Cell Therapy and HCV in addition to new revenue contributions from Trodelvy and more modestly Hepcludex for HDV.

Additionally, other product revenues of $291 million grew 20% year over year, driven by increased demand for AmBisome outside of the U.S. to treat mucormycosis, which has seen a rise in incidents in patients hospitalized with COVID-19. Sequentially, we saw 9% growth for total product sales, excluding Veklury, primarily driven by growth in Biktarvy. Moving to Slide 9, HIV product sales were $3.9 billion, up 8% sequentially and down 2% year over year.

Compared to the second quarter of 2020, total HIV revenue reflected strong Biktarvy growth that more than offset the $322 million lower revenue from Truvada and Atripla following their loss of exclusivity. Compared to last quarter, HIV grew $288 million, reflecting customary seasonal inventory dynamics and growing demand for treatment. Biktarvy revenue of $2 billion was up 24% year over year and 9% sequentially, with quarter-over-quarter growth, primarily driven by increased demand. Biktarvy remains the #1 prescribed therapy in the U.S.

across naive, switch and continuing patients and remains #1 in naive across all EU5 countries. Approximately 70% of switches from both Gilead and non-Gilead regimens, result in incremental revenue. Overall, and despite the ongoing impact of the pandemic, Biktarvy continues to gain market share with 1% share growth versus last quarter in both the U.S., as well as the EU5. Descovy revenues of $435 million grew 21% sequentially due to a modest improvement in the demand for prep and more favorable inventory and pricing dynamics that we typically see in the second quarter relative to the first.

As we highlighted in prior quarters, we’ve been working with payers to ensure patients’ community to have access to Descovy in light of entry of generic alternatives for Truvada. We’re really pleased to see the strong sequential growth in Descovy, and we continue to maintain mid-40% share despite generic impacts. Year over year, Descovy grew 4%, largely due to higher demand for PrEP. And overall, PrEP demand is showing signs of recovery and is expected to continue to improve as pandemic restrictions phase out.

Earlier this month, federal FAQs for the U.S. Preventative Services Task Force were released. It provided greater clarity as to the importance of PrEP in ending the epidemic, and we’re really encouraged by this recent development. We hope it will help to minimize the barriers of PrEP use going forward.

Before I transition to other products, I just wanted to take a moment to share some perspective on the HIV treatment market, given the longer-than-expected pandemic impact. In regions outside of the U.S., such as Europe, we’re beginning to see signs of recovery in the dynamic market with second-quarter trends generally in line with our expectations. In the U.S., however, the pace of the pandemic recovery was slower than we expected in this last quarter. And while we’re seeing signs of recovery in PrEP and some sequential growth in the treatment market, it’s clear that it will take several quarters for treatment to return to pre-pandemic levels.

In treatment, there are really two pandemic-related headwinds that we observed. First, lower HIV screening and diagnosis resulting in lower treatment initiation; and second, due to the limited support services available during the pandemic, we’ve seen a higher number of patients discontinue their HIV treatments. Taken together, these two factors have reduced the number of active patients on HIV therapy entering 2021, thereby reducing the overall volume of new and refill prescriptions we would expect to see in 2021. We did, however, see growth resume from this lower base in the second quarter.

After prior quarter-over-quarter decline, second-quarter U.S. HIV treatment prescriptions grew 2% and we expect the market to grow at historical rates once screening and diagnosis rates return to pre-pandemic levels. To continue our efforts to advance progress against the HIV epidemic, we are partnering with healthcare professionals, advocacy groups and policymakers to raise awareness of the unique challenges COVID-19 poses to HIV screening, diagnosis and adherence . Our goal is to help healthcare providers ensure that patients continue to be diagnosed and treated.

Given the strength of the demand fundamentals for Biktarvy, Descovy for PrEP and other Gilead HIV products, we remain confident in our competitive positioning now that many communities aren’t using social distancing requirements. In the meantime, we continue to see strength in underlying treatment demand with no material changes in the competitive landscape, with our total Gilead treatment market share holding steady at 75% in the U.S. and just under 50% in Europe despite competition and the entry of new generics. Next, on Slide 10, HCV product sales in the second quarter were $549 million, up 23% compared to last year, but patient starts remain well below pre-pandemic levels.

The growth reflects a modest sequential recovery in HCV patient starts in the U.S. in Q2 ’21, in addition to an artificially low Q2 of ’20 that was impacted by unfavorable government rebate adjustments. We’ll be watching for further signs of recovery in the third quarter. Both U.S.

and EU Gilead market shares remain steady at around 60% and 50%, respectively. Moving to Slide 11, HBV and HDV product sales were $237 million, up 8% year over year with improving patient starts on Vemlidy, particularly in ex U.S. markets. In its first full quarter as part of Gilead Hepcludex contributed $7 million and is currently available in France, Germany and Austria.

We’re excited to be working with the various reimbursement authorities to increase patient access and expect to secure full reimbursement in the major European markets in 2022. Moving to Trodelvy on Slide 12, product sales in the second quarter were $89 million, up 24% quarter over quarter, driven by demand for the two new indications approved in April, namely second-line plus metastatic triple-negative breast cancer and urothelial cancer. We continue to be encouraged by the positive feedback from physicians on the Phase 3 ASCENT data, which demonstrated a one-year medium overall survival benefit for second-line metastatic TNBC patients treated with Trodelvy. To build on this growing interest, we’re increasing community awareness, especially the expanded indication to second line in TNBC.

And we expect to see growing demand as breast cancer screening ramps back up to pre-pandemic levels. IQVIA data suggests that breast cancer screening volumes were about 20% lower in the U.S. in 2020 compared to 2019. This suggests as many as 41,500 breast cancer patients have not been diagnosed during the pandemic.

On behalf of Christi and the Kite team, I’m pleased to share a Cell Therapy commercial update on Slide 13. Total cell therapy product sales totaled $219 million in the second quarter, representing 39% growth year over year, driven by both Yescarta and Tecartus. Yescarta growth was driven by strong demand in Europe, as well as successful follicular lymphoma launch in the U.S. Increased competition, particularly in third-line LBCL, continues to raise the profile of cell therapy and is positive to Kite overall.

We remain confident in Yescarta’s competitive profile and positioning, and are particularly proud of Kite’s industry-leading manufacturing turnaround time and reliability. Our results also reflected strong momentum from the Tecartus mantle cell lymphoma launch, highlighting the unmet medical need for MCL patients. We continue to add new indications and geographies for our cell therapy products. For example, the Fosun-Kite joint venture recently received approval in China for Yescarta as the first cell therapy to treat third-line LBCL.

And we’re excited to see the top-line data for ZUMA-7, getting us a step closer to second-line LBCL cell therapy. Even as we prepare for discussions with regulatory agencies later this year, commercial and manufacturing preparations are ramping up to ensure sufficient capacity and support for second-line LBCL demand in both the U.S. and in Europe. Christi is here with the team to take your questions on cell therapy later in the call.

But for now, I’ll hand it over to Merdad to walk us through the pipeline updates.

Merdad ParseyChief Medical Officer

Thank you, Johanna. As Dan mentioned, it’s been a gratifying year so far, delivering on all our key pipeline commitments, supporting Gilead’s ambitions to extend our leadership in HIV and creating a broader portfolio spanning virology and oncology and building our portfolio in inflammation. I’ll spend our time today on the highlights of the quarter and pointed to the appendix of the earnings presentation for a more complete view of our pipeline activities. First, in HIV, as you can see on Slide 15, programs for our investigational lenacapavir agent continued to progress.

At the recent International Aid Society Meeting, we shared data from the Phase 1/2 CAPELLA study that evaluated heavily treatment experienced individuals who’ve already developed resistance to multiple antiretroviral drugs. CAPELLA demonstrated lenacapavir’s potency in this difficult-to-treat population. Despite significant prior resistance, antiviral activity was observed starting at day 15. By week 26, 81% of individuals had viral suppression when lenacapavir was combined with an optimized background regimen.

Based on these data, we filed a new drug application. If approved, this would become the first six-month long-acting subcutaneous injection regimen available and deliver a welcome new option for people living with HIV, who have developed multidrug resistance to other antiretrovirals. Also with IAS, we presented strong interim results from the Phase 2 CALIBRATE study, evaluating lenacapavir in a treatment-naive population. In CALIBRATE, participants receive lenacapavir either as a subcutaneous injection or as a daily oral pill in combination with Descovy.

At week 28, 94% of subjects achieved HIV-1 RNA loads of less than 50 copies per ml. These findings will be used to help inform our broader efforts establishing lenacapavir as a foundational agent for our long-acting franchise. Late last month, we screened the first patient for the Phase 3 PURPOSE-II trial, studying lenacapavir for HIV prevention in cisgender men, transgender women, transgender men and gender nonbinary people who have sex with men and are at risk of HIV infection. We expect to initiate the Phase 3 PURPOSE-I study of lenacapavir for HIV prevention in adolescent girls and young women later this year.

Finally, we’re actively working on the co-formulation for the long-acting investigational oral and injectable combination of lenacapavir and islatravir and expect to initiate the oral Phase 2 trial by the end of the year. Moving on to HDV on Slide 16. Last month at the International Liver Congress, we presented data from the MYR301 and MYR204 programs. MYR301 is a Phase 3 registrational study evaluating bulevirtide as monotherapy for the treatment of HDV.

Interim results demonstrated that bulevirtide was well tolerated in both cirrhotic and noncirrhotic patients, with compensated chronic HDV infections. At week 24, bulevirtide treatment was associated with significantly greater HDV RNA declines and improvements in biochemical measures of disease activity compared to no treatment. Moreover, there were no treatment-related serious adverse events leading to discontinuation. These results continue to support the effectiveness of the two-milligram dose, which has received conditional approval from the EMA and will form the basis of the BLA filing plan for later this year in the U.S.

As part of our HDV cure efforts, we also presented interim data from the MYR204 Phase IIb study, investigating finite regimens of bulevirtide, both as monotherapy and in combination with PEG interferon alpha. Both monotherapy and combination treatments of bulevirtide were found to be generally well tolerated and more effective than PEG interferon alone through 24 weeks of therapy. The primary endpoint analysis occurs at 24 weeks after completion of therapy and includes virologic and biochemical response data. We look forward to sharing those data when available.

Moving to Slide 17 and on behalf of Christi and the Kite team, as you know, we shared earlier the strong positive top-line data from ZUMA-7, the landmark 359-patient Phase 3 study evaluating Yescarta in second-line LBCL. The study met the primary endpoint for event-free survival with a hazard ratio of 0.398, representing a 60% improvement in event-free survival compared to standard-of-care stem cell transplant. Yescarta had a safety profile comparable to or better than what we have seen in the third-line setting. This is a clinically and statistically meaningful improvement in outcomes that, if approved in the U.S., could extend Yescarta’s reach to a total unique population of 14,000 patients annually in the second and third-line LBCL setting.

ZUMA-7 also met the key secondary endpoint of objective response rate. As expected, data for overall survival is immature at this time, but the interim analysis suggests a favorable trend in this critical milestone. In summary, we’re very excited about the potential benefit to patients demonstrated in ZUMA-7 and look forward to beginning discussions with regulatory agencies later this year as we work toward potential SBLA and MAA filings for Yescarta in second-line LBCL. And separately, we’re on track for the Phase 2 readout for our first-line LBCL study before the end of the year.

Beyond LBCL, we’ve completed filing Yescarta with the EMA for patients with follicular lymphoma after three or more lines of systemic therapy. We also have a PDUFA date of October 1 under accelerated review with the FDA for Yescarta’s MALL. And of course, while our internal focus remains on ontologist cell therapies, we continue our engagement in alternative approaches. Most recently partnering with Shoreline Biosciences to develop novel off the shelf allogeneic cell therapies based on natural killer targets for hematologic cancers.

Slide 18 is a recap of our pipeline execution so far this year. In addition to the items we have discussed already, our partner Arcus has provided an early interim update of their Phase 2 ARC-7 trial in late June, demonstrating clinical activity in the anti-TIGIT domvanalimab-based doublet and triplet combinations. Zimberelimab, our anti-PD-1 antibody, saw similar levels of activity in the monotherapy arm compared to marketed anti-PD-1s. Based on the interim analysis, we’re pleased that ARC-7 and the confirmatory Phase 3 ARC-10 trial will continue to enroll as planned.

We look forward to seeing how the data mature with additional patients and duration of follow-up to inform our opt-in decision. Separately, our partner, Galapagos, also shared data readouts from their Toledo SIK2/3 programs across psoriasis, ulcerative colitis and rheumatoid arthritis and the plaque psoriasis data from their TYK2 program. Both studies were early and had small samples, and we look forward to additional data. We also remain focused on the following upcoming milestones.

For Trodelvy, we continue to target a TROPiCS-02 PFS readout this year. The study is an event-driven Phase 3 trial in patients with hormone receptor positive HER2-negative metastatic breast cancer. Pending data, we will evaluate and then determine the appropriate regulatory next steps. We estimate there are roughly 17,000 patients in the U.S.

who could benefit from Trodelvy in this setting. We continue to expect the Phase 3 non-small cell lung cancer for Trodelvy to initiate in the second half of this year. We plan to share an update from the TROPiCS-03 basket study on lung cancer later this year and will separately provide updates on head and neck squamous cell carcinoma and endometrial cancer as those data mature. We anticipate a Phase Ib readout from magrolimab in MDS later this year, and pending data will engage with regulators as we explore potential BLA filing for accelerated approval.

If approved, magrolimab will be the first-in-class checkpoint inhibitor targeting CD47 and Gilead’s first frontline oncology indication. There’s a significant unmet need for MDS, with no new treatments approved in 14 years despite 15,000 new patients being diagnosed each year in the U.S. alone. We continue our development efforts in AML and have enrolled our first patient in the Phase 3 frontline AML magrolimab study.

Before I wrap up the pipeline discussion, I wanted to share an update on remdesivir. We’ve decided not to move forward with an inhaled formulation of remdesivir based on the results of our initial proof-of-concept study, suggesting suboptimal lung deposition. To address patient needs in the evolving pandemic, we are continuing our efforts on advancing multiple novel antivirals. We expect to submit IND filings later this year or early next year for these agents.

We remain committed to supporting patients through this pandemic and continuing our legacy of developing antiviral therapeutics for the treatment of emerging diseases. Finally, on Slide 19, I want to recognize the teams at Gilead and Kite. Compared to just two years ago, our pipeline has grown from 30 clinical stage programs to over 50 today, and resulted in a considerably more diverse set of assets that can be transformative, not only for patients but for Gilead. The Gilead and Kite teams have worked tirelessly to deliver on our pipeline programs during this time of dramatic growth despite the pandemic.

It’s a thrilling time to be part of the team, with tireless dedication and commitment to helping patients. I look forward to updating you on our progress in the quarters ahead. With that, I’ll hand the call over to Andy to walk us through the financial results of the quarter.

Andrew DickinsonChief Financial Officer

Thank you, Merdad, and good afternoon, everyone. Moving to Slide 21, our financial results in the second quarter were solid overall, with total product sales up 21% year over year, given the important role Veklury continues to play in this pandemic. Excluding Veklury, total product sales grew 5% year over year, with strong Biktarvy growth more than offsetting lower Truvada and Atripla revenues. In addition to impressive growth in cell therapy and, of course, the new revenue contribution associated with Trodelvy, which was not part of our portfolio in the second quarter of last year.

Moving down the P&L, non-GAAP product gross margin was 86.4% in the second quarter, 210 basis points higher year over year and primarily associated with a lower royalty expense. Non-GAAP R&D was $1.1 billion, down 9% year over year with lower remdesivir-related investments as compared to the same period last year, partly offset by higher investments across our pipeline, notably Trodelvy and magrolimab. Non-GAAP SG&A expense was $1.1 billion, down 4% year over year, primarily due to lower legal expenses, offset in part by continued commercial investment in Trodelvy and Veklury outside the United States. Moving to tax, we realized a lower effective tax rate of 19.6% for the quarter or down 320 basis points year over year due to a shift in geographic earnings mix.

Overall, our non-GAAP diluted earnings per share was $1.87 per share in the second quarter of 2021, compared to $1.11 for the same period last year. The year-over-year improvement primarily reflects higher product sales due to Veklury, higher gross margin, as well as lower operating expenses and a lower effective tax rate, offset by lower interest income. Overall, we’re encouraged by our first-half results shown on Slide 22. Moving to Slide 23, you can see that we are updating our guidance for 2021.

As always, the duration and magnitude of the COVID-19 pandemic continue to be uncertain and the rate and degree of these pandemic impacts, as well as the corresponding recovery from the pandemic may vary across our business. With that said, we now expect full-year total product sales in the range of $24.4 billion to $25 billion, compared to our previous range of $23.7 billion to $25.1 billion. The new range increases the midpoint from $24.4 billion to $24.7 billion, and reflects our solid results year to date, as well as our updated expectations for the second half of the year. With first-half Veklury revenue of $2.3 billion, we now expect full-year Veklury revenue in the range of $2.7 billion to $3.1 billion, compared to our previous $2 billion to $3 billion range.

Our updated range reflects the ongoing role of Veklury in this pandemic and assumes we’ll continue to see regional outbreaks. The situation continues to be dynamic, and we’ll likely update our thinking again when we report our earnings after the third quarter. Back to our guidance, we now expect total product sales, excluding Veklury, for the year to be in the range of USD 21.7 billion to $21.9 billion, compared to our previous range of $21.7 billion to $22.1 billion. This tightening of the range reflects the longer-than-expected pandemic impact on our business, including the latest increase in COVID-19 cases.

As Johanna discussed, the pandemic has most notably impacted our HIV treatment business, where we saw substantially fewer treatment initiations and a greater number of discontinuations than expected in 2020. It’s taking longer than we expected for treated patient volumes to ramp back up to more normal levels, particularly in the United States. That said, we saw encouraging signs of recovery in the HIV market in the second quarter, and our guidance assumes recovery will continue through the remainder of the year. Based on market share dynamics, we remain very confident in our competitive positioning, and we believe we’re well-positioned as the recovery continues.

Looking at the rest of our P&L. We now expect non-GAAP product gross margin in the range of 86% to 87%, reflecting the lower mix of HIV revenue. We now expect non-GAAP R&D to decline low to mid-single-digit percentage compared to 2020 levels. This primarily reflects the timing of investments, and we remind you that the expenses in both R&D and SG&A are back-end loaded this year, increasing sequentially from Q2 into Q3 and then even more from Q3 into Q4.

Our non-GAAP SG&A guidance remains unchanged at flat to low single-digit percentage decline over 2020. In R&D, we’ll be ramping up additional studies with magrolimab, Trodelvy, long-acting combination work with lenacapavir for the treatment of HIV and other pipeline activities. And in SG&A, we will be ramping up marketing activities to support our growing portfolio of indications, such as with Trodelvy and Tecartus. Finally, reflecting the updates to our revenue, gross margin and operating expense guidance, we now project non-GAAP diluted EPS between $6.90 per share and $7.25 per share for the year, and GAAP diluted EPS between $4.70 and $5.05.

Additionally, our capital allocation priorities have not changed, and we remain committed to our dividend. Year to date, we’ve paid down $1 billion — $1.25 billion in debt, and we’re on track to repay at least $4 billion in debt by the end of the year. With that, I’ll invite the operator to begin the question-and-answer session.

Questions & Answers:


[Operator instructions] Our first question comes from Cory Kasimov with J.P. Morgan. Your line is now open.

Gavin ScottJ.P. Morgan — Analyst

Hi. this is Gavin on for Cory. Just wanted to go back to the U.S. HIV business.

Can you provide additional color, particularly in the context of why this is so much different from the ex U.S. markets? And what is the most important factor you’ll be watching for to have confidence in the U.S. market normalizing? Thank you.

Daniel O’DayChairman and Chief Executive Officer

Yeah. Thanks a lot, Gavin, for joining. I’m obviously going to turn that over to Johanna. I’d just point out that we continue to do really well in our share and certainly, Biktarvy growth and are well-positioned as the market rebounds.

And with that, I’ll turn it over to Johanna for some specifics.

Johanna MercierChief Commercial Officer

Thanks. Gavin, thanks for your question. I think from a market dynamic standpoint, what we’re seeing is we saw a little bit last year in Q2, most of the industry was actually slowing down pretty quickly in Q2. HIV took a little bit longer, and it’s kind of that playing out in ’21.

It’s taking a little bit longer to come back and bounce back. One of the major reasons for that has to do with your dynamic market being much smaller in this market. You have a very large pool of patients that are just continuing patients. And you’re really playing in the dynamic market with your naive patients coming in and your switches and your restarts, really around 5% or so.

And so that’s why it’s taking a little bit longer as we’re going through this. From a different standpoint between U.S. and Europe, I think it has more to do with the fact that in Europe, there’s diversity across some of the different countries as to the pandemics and the timing of kind of the recoveries or even some of the surges that happened. So it’s a little bit more blended than what we’ve seen in the U.S.

thus far. And so I think that’s just what’s playing out here. Obviously, the bigger impact being in the U.S. because that’s where most of our business lies in HIV.

And just to close out on that, the — that’s from a market standpoint, and it’s very different than kind of the fundamentals of our HIV business. I think what we’ve seen with Biktarvy, we’re really quite pleased with in light of the fact that not only it’s grown quarter over quarter by 1 point, both in the U.S., as well as in the EU5. But also, if you think about it over the last 12 months, it’s grown 6-point share over a very strong base. We’re just under 40%, we’re at 39% share at this point in time.

So we’re very pleased with the continued growth of Biktarvy, and you can appreciate that because it’s such a larger base, that’s going to get more challenging as we move forward. And that’s why I think we’re excited about the market coming back a little bit. We’ve seen it come back in Q2. Where the market goes, obviously, our HIV business goes because we own 75% of the market.

And so therefore, we’re watching that very closely, but we would expect that recovery to continue, although at a slower pace than we had originally expected.

Daniel O’DayChairman and Chief Executive Officer

That’s great, Johanna. Anything on the indicators. I think you’ve mentioned but anything more on the indicators that you’ll be looking for.

Johanna MercierChief Commercial Officer

Yes. So we’ve been looking, of course, at the HIV screening and the diagnosis and how that’s playing out. And we’re still under by about 13% to — below pre-COVID levels. So I think once those come back up, I think that would be something that we’re watching very closely and also the drop-off rates.

We talked a little bit in — earlier about the adherence piece of the puzzle, because you have less patient support groups around, you have less surround sound around those HIV patients. You have a lot of those case managers and physicians that have moved over to treat COVID-19 and so for impacting HIV, a little bit disproportionately. And so we’re also looking at those drop-offs. And we’ve seen those drop-offs come back to normal to pre-COVID levels just most recently.

And so that’s another positive sign to that recovery of the market.

Daniel O’DayChairman and Chief Executive Officer

And Gavin, obviously, just from a patient perspective, we have been and will continue to be dedicated to helping patients, particularly in underserved communities get back into the care system. I think that’s something that Gilead prides itself on. And it’s exceptionally important as a leader in HIV medicines to make sure we are always on the side of the patients as we emerge from this pandemic. So thanks for the question, Gavin.


Thank you. Our next question comes from Terence Flynn with Goldman Sachs. Your line is now open.

Terence FlynnGoldman Sachs — Analyst

Great. Thanks so much for taking the question. Maybe a two-part for me. First for Johanna, just wondering if you can provide any more insight on the Trodelvy launch, specifically the split of sales by either setting or indication.

And then for Merdad, can you remind us of the size of the lung cancer cohort in TROPiCS-03 and then how are you thinking about the potential risk of ILD in that population? Thank you.

Daniel O’DayChairman and Chief Executive Officer

Thanks, Terence. Yes, go ahead, Johanna.

Johanna MercierChief Commercial Officer

Sure. Thanks for the question. So yes, so we’re really pleased with the Trodelvy sales. I had 24% growth quarter over quarter.

I think, is a very strong quarter, and I think that really has to do with the approval, the second line plus approval that we got in metastatic triple negative breast cancer early April. It’s also related to the fact that because now we have the full approval, we have the opportunity to promote the incredible overall survival data that we have with the ASCENT data. And so that’s been a big piece of the puzzle. If you’re asking me to split the sales per line of therapy, that’s very challenging in light of the claims data that we have.

But what I would say if it’s more about bladder cancer versus triple-negative breast cancer, I would say most of that is triple-negative breast cancer, probably about a 90-10 ratio as our bladder cancer is much smaller. Although we’ve done some nice inroads there already and are looking at about just under 10% share in bladder right now with Trodelvy. So we’re excited about that as well. Merdad?

Merdad ParseyChief Medical Officer

And then with TROPiCS-03, it’s a basket study. So the ends per arm are not hard and fast. We’ll probably be looking at data once we get to the 20, 30 range in there. But it’s not predetermined.

So I wouldn’t want to overstate it. Regarding ILD, we are definitely very sensitive to and watching for it, as you can imagine. To date, we haven’t had any reports of that, but we’re ever vigilant. So…

Daniel O’DayChairman and Chief Executive Officer

Great. Thank you both. Thanks Terence. We’ll get the next question now, please.


Thank you. Our next question comes from Brian Abrahams with RBC Capital Markets. Your line is now open.

Brian AbrahamsRBC Capital Markets — Analyst

Hey, good afternoon. Thanks for taking my question. A question regarding HIV life cycle. You recently reported data for subcu lenacapavir-based combo with treatment-naive HIV.

I’m curious, how do the learnings there with respect to the resistance profile you’re observing, shape how you think about the future development steps vis-a-vis potentially exploring higher doses, more frequently — more frequent than every six-month injections and/or combining with agents that might have a higher intrinsic barrier resistance versus F/TAF. And then, I guess, along the lines of HIV life cycle, I’m also curious your level of confidence as to the potential of F/TAF to have exclusivity beyond 2025? Thanks. 

Daniel O’DayChairman and Chief Executive Officer

Great. Why don’t we have you start, Merdad, and perhaps Andy can comment a little bit on the second piece, too.

Merdad ParseyChief Medical Officer

Yeah, thanks. It’s a very good question. And I think if you think about the patients in that trial, these are highly treatment-experienced patients who often develop resistance because of noncompliance. And when these subjects are getting a subcu injection of lenacapavir, remember that these patients are going to potentially continue to go off and on their oral regimens.

As we think about the future, as you know, we are — for treatment going outside the highly treatment-experienced population, we’re really thinking about how we’re going to combine lenacapavir with other long-acting agents like islatravir. And as we do so, I think the concerns about patients potentially having effective monotherapy with lenacapavir go away in some regards, right, ensuring that patients are taking multiple agents at the same time is going to be really important for us.

Daniel O’DayChairman and Chief Executive Officer

Thanks, Merdad. And perhaps, Andy, you want to comment on the exclusivity question for Brian?

Andrew DickinsonChief Financial Officer

Sure. I’d be happy to. Brian, thanks for the question. As you know, there’s litigation that’s underway.

There are some recent developments that the number of analysts wrote about. Our base case continues to be that there will be generics arriving in 2025 and 2026 in the U.S. and EU respectively, but we think we have a strong case and that there — we look forward to continuing to prosecute the case and we’ll see where it plays out. We should have an additional update later this year.

So that’s really where it stands.

Daniel O’DayChairman and Chief Executive Officer

Thanks, Andy. Can we have the next question, please?


Thank you. [Operator instructions] Our next question comes from Geoffrey Porges with SVB Leerink. Your line is now open.

Geoffrey PorgesSVB Leerink — Analyst

Thanks very much for taking my question. So just a couple of parts in my question. Could you clarify a couple of your partnerships? There’s been some news from Galapagos, you’ve invested over $5 billion there. Are you going to take on any of those drugs from the Toledo portfolio that the company recently highlighted? And then related to that, your Arcus partnership.

Does your guidance include the mild upfront cost of opting in for any of those programs? And what’s the trigger and the window for when you can opt in to any of those three programs? Because they sort of appear on your pipeline slide, but it’s not completely clear whether they’re in or out. So could you clarify where you’re going with those two partnerships?

Daniel O’DayChairman and Chief Executive Officer

Sure, Geoff. Thank you very much for the question. And I’ll start a little bit and then ask Merdad and Andy, if he wants to add anything as well. So I think, first and foremost, I think we’re — we believe deeply in partnerships.

We have a robust internal portfolio. And we also, as you know, have designed these opt-ins as a way to expand our portfolio in, different therapeutic areas. Starting with Galapagos, as you know, which was predominantly focused on inflammation. At this stage, we don’t have any opt-in milestones right now with Galapagos.

We’re working closely with them on their science and their discovery platform and some of their preclinical to clinical molecules to support them in their efforts. But at this stage, we don’t have anything more to report other than like Galapagos has reported on the, for instance, Geoff, to your question on the Toledo program. But rest assured that as those programs evolve and mature and develop, we’ll keep you informed. Perhaps, Merdad, if you want to say anything else in Galapagos and bridge to Arcus?

Merdad ParseyChief Medical Officer

Yes. I think the stories are similar. We like to keep you apprised of what could potentially come into our portfolio, and we have the opt-in rights too for Arcus. I mean I think Dan laid out Galapagos well.

For Arcus, we continue to wait for data to mature. And once the data get to a level of maturity where we can really make the call, that’s when we’ll have our opt-in. We have not included, and Andy will confirm for me, but we have not included the financials of a potential opt-in in our guidance at this point.

Daniel O’DayChairman and Chief Executive Officer

Andy, you want to [inaudible]

Andrew DickinsonChief Financial Officer

That’s correct. Yes. No, I’m happy to follow up here, Geoff, good question. And nothing has changed from the guidance at the beginning of the year.

So our R&D spend and all of our expense guidance does not include the opt-ins on any of the programs that we have options to, including the three programs that you mentioned at Arcus. You also asked about the opt-in windows. The opt-in window for the first TIGIT antibody should be coming most likely at the end of this year. It could be early next year, but it’s most likely at the end of this year, we’ll have enough patient data to trigger the opt-in or our desire to opt in potentially early.

On the other two programs, the adenosine programs at Arcus, that’s most likely next year. And again, there may be additional data that comes this year that if it looks really strong. We want to move as quickly as we can, and we can opt in early, Geoff, on those programs. And then on Toledo, it’s relatively simple.

And all of the Galapagos programs that opt-in comes after Phase 2 enabling studies. So the Toledo programs are a long ways away from a potential opt-in decision.

Merdad ParseyChief Medical Officer

Phase 3 enabling.

Andrew DickinsonChief Financial Officer

Yes, I’m sorry, Phase 3 enabling. Thank you.

Daniel O’DayChairman and Chief Executive Officer

Geoff, and I’d just kind of round out to your question. I mean, there’s obviously many other partnerships we have that we’re working closely with at different phases, but those are the specific ones you asked about. Thank you very much for the question. Can we have the next question please?


Thank you. Our next question comes from Geoff Meacham with Bank of America. Your line is now open.

Geoff MeachamBank of America Merrill Lynch — Analyst

Great. Afternoon, guys. Thanks for taking my question. A question for Dan or Merdad on COVID.

There’s a high expectation that vaccines are here for a while now that the Delta variant has really changed the dynamic. The question is, has the strategic value of Veklury change for you guys as new cases have ticked up? I know you decided not to pursue inhale, but is there a life cycle here worth investing in over the long term? Thank you.

Daniel O’DayChairman and Chief Executive Officer

Thanks, Geoff. I’ll start, and then Merdad will either correct me or add important information to it. But I think — I mean, just to emphasize, the importance of Gilead’s legacy in antivirals and frankly, our strength in that too, to us as well. So being, of course, the first company to have — and the only company to have an approved antiviral for COVID is no accident.

Obviously, it’s decades of experience, decades of investments in a variety of emerging viruses, including COVID, and we haven’t stopped. So to your point, Geoff, I think we’re all learning about this pandemic as it rolls out. And it’s certainly going through different phases, and we think will continue to go through different phases. And therefore, we are, if you like, kind of doubling down on an ability to think about antivirals outside the hospital setting, where remdesivir plays such an important role.

And maybe with that, I’ll hand it over to Merdad, as a clinician, how you might also see the future [inaudible] and also our role in it.

Merdad ParseyChief Medical Officer

Yes, thanks. I think we have, I think, been pretty consistently of the mindset that the vaccines will make a tremendous impact in the case numbers and those sorts of things. Even though I think even when we get to some sort of equilibrium, unfortunately, they’ll continue to be, we believe, infections. People will continue to get infected and some proportion of those patients will end up in the hospital.

So we do believe that Veklury in the hospitalized setting is going to be — continue to be really important for treating those patients. And as Dan alluded to, we continue to believe and are committed to treatments — making treatments available in the outpatient setting. So I wouldn’t — the inhaled nebulized approach didn’t give us the results we were hoping for, the consistency we were looking for. But because we have other agents in our pipeline based on our virology expertise, we will be bringing those forward and really focusing on the outpatient setting there.

So we continue to believe that having a treatment available for people, whether they’re vaccinated or not, is going to be important for the foreseeable future.

Daniel O’DayChairman and Chief Executive Officer

And Geoff, what I might add is that our preclinical folks continue to study remdesivir against a variety of variants. In fact, all four major variants of concerns, so the Alpha from the U.K., the Beta from South Africa, the Gamma from Brazil and the Delta from India, and all are fully sensitive against — or remdesivir is as sensitive against all those strains. Which would make sense because we’re not seeing any mutations in the polymerase remdesivir binding site. And so I think it’s important as we think about next-generation products to also think about medicines that will be effective against these ongoing variants like remdesivir.

It’s an important bar for us as we move forward. Thanks, Geoff, for the question.


Thank you. Our next question comes from Umer Raffat with Evercore. Your line is now open.

Umer RaffatEvercore ISI — Analyst

Hi, guys. Thank you for taking my question. I had two quick ones as well. First, have you had an interim PFS on the HR positive study of Trodelvy? And secondly, congrats on Bill Grossman’s hire from Arcus.

And I was wondering to what extent was the decision of Bill bring onboard driven exclusively by Bill’s familiarity with Arcus programs? Thank you very much.

Daniel O’DayChairman and Chief Executive Officer

Yeah. Why don’t you start, Merdad?

Merdad ParseyChief Medical Officer

Yeah. Thanks, Umer. Great questions. Yes, we have not done the interim PFS analysis as we’ve talked about, that will happen certainly before the end of the year, we hope.

And we’re — that’s still what we’re tracking to. But we have not done the analysis yet. So we remain blinded to those data. And then in terms of Bill, I think I wouldn’t necessarily tie it as you’re suggesting to Arcus, it’s certainly an advantage for us that should we opt into Arcus programs, Bill will bring familiarity.

But for us, Bill’s experience and leadership and his excitement about being here and overseeing the overall portfolio were the drivers for Bill coming onboard.

Daniel O’DayChairman and Chief Executive Officer

Yeah. And I would just add, Umer, I mean, look, many of us know Bill, you know him as well. Our relationship with Arcus is extremely important and continues to be. And this was an example of Bill seeing a career opportunity and seeing an evolution for his career that made sense for him.

We certainly want to make sure that Arcus continues to have the skill set that it needs to be successful. We have the skill set that we need to be successful. I think it’s just a good example of how partners collaborate at times. And so I just wanted to emphasize, our relationship with Arcus is unchanged and as strong as ever.

Umer RaffatEvercore ISI — Analyst

Thank you.


Thank you. Our next question comes from Michael Yee with Jefferies. Your line is now open.

Michael YeeJefferies — Analyst

Hey, thanks for the question. Appreciate it. maybe a question for Merdad on Trodelvy a couple of parts. In the TROPiCS-02 study, you had the smart decision to take a look at that, enlarge it, powered for PFS, etc.

Did you have any information that could help give you confidence around the powering? And any information that would help you give confidence in the overall study, such as the number of events that have passed or anything like that? Or even knowing that it had passed a futility, if you could even comment on that. And then on the lung data that’s coming up, can you just comment around your belief in the profile versus the competitor? Is it similar efficacy, better safety? Or how should we interpret that data when it comes later this year? Thank you.

Daniel O’DayChairman and Chief Executive Officer

Nice to hear your voice, Michael. Over to you, Merdad.

Merdad ParseyChief Medical Officer

Yeah. Thanks, Michael. On the TROPiCS-02 study, we have not done a futility analysis. We are — we continue to look to those data maturing and getting the number of events that we need for the PFS analysis that we have planned.

We’re pretty confident in our powering. And in particular, since we expanded the sample size to make sure that we are able to hit the PFS endpoint. Of course, the relevant issue is more the duration of PFS that we get. But from a powering standpoint, we’re comfortable.

And it’s just a matter of seeing those data. From an ongoing event standpoint, I think we are where we thought we would be at this point, and it’s really around just letting the events come in, make sure they get adjudicated, we clean the data in time to do the analysis properly. So that’s where we are with that. And then in terms of the lung data on efficacy, yes, I mean, I think — as I think we’ve said before, we’re really proceeding somewhat at risk and pretty aggressively, partly based on our belief in the drug, partly because of what we’ve seen with other agents in lung and partly based on our early data that you’re familiar with in lung that we’ve seen.

Of course, we want to make those data more robust while we go into the Phase 3 world. So we are going to augment our existing data to make sure that we are mitigating our risk somewhat. But thus far, I think what we are hoping for is efficacy that certainly is comparable to what the benchmark might be, even though I think it’s too early to say what that benchmark is with the direct competitor. But we are, again, I think, confident about our ability to bring safety profile that hopefully, will be better for patients.

Daniel O’DayChairman and Chief Executive Officer

Excellent. Thank you, Michael. Can we have the next question, please?


Thank you. Our next question comes from Alethia Young with Cantor. Your line is now open.

Alethia YoungCantor Fitzgerald — Analyst

Hey, guys. Thanks for taking my questions. I’m just curious about, again, going back to the Arcus collaboration with ARC-7. How do you think about what the hurdle is for a triple? Do you think that it has to be more than like some of the competitors like Roche happen in doublets do you think?

Daniel O’DayChairman and Chief Executive Officer

Thanks, Alethia. Merdad?

Merdad ParseyChief Medical Officer

I think we have the luxury of being able to look at a singlet, a doublet and a triple here. We would be, of course, excited if the triplet differentiates from the doublet and provides better efficacy. I think that’s what we’d be looking for. And so as the data mature, looking for some signals, some — a reason to believe that the triplet is performing more robustly than the doublet is probably going to be our focus.

We’d be very excited if that plays out. It gives us, I think, a pretty unique position.

Daniel O’DayChairman and Chief Executive Officer

Thanks, Alethia. So I think we have time for one more question, and thanks, everybody, for your involvement. Can I have the last question, please?


Thank you. And the last question comes from Ronny Gal with Bernstein. Your line is now open.

Ronny GalSanford C. Bernstein — Analyst

Hi, everybody, and thanks for squeezing me in. Question about the projections for HIV for the next couple of years. Part one, I guess, is you changed your reimbursement policy on 340B clinics next year. How big essentially is that difference in terms of what it creates for you? And where on P&L will it appear on revenue on SG&A? And the second one, you already mentioned the PrEP barriers are dropping with preventative treatment designation for PrEP.

I can’t figure if this is good or bad for you from the perspective of branded drug adoption, given that they don’t have to cover branded drugs.

Daniel O’DayChairman and Chief Executive Officer

Thanks, Ronny. So over to you, Johanna.

Johanna MercierChief Commercial Officer

Sure. Ronny, I’m assuming you’re talking about the patient assistance program changes?

Ronny GalSanford C. Bernstein — Analyst

Correct. Yeah.

Johanna MercierChief Commercial Officer

OK. So I want to differentiate that. Those aren’t 340B changes. That’s actually a program that’s really in line with our commitment to help end the HIV epidemic.

To date, the program has actually provided free drug to more than 250,000 individuals. And really, that’s what it is. It’s a free program that was always intended and will continue to provide free Gilead medication to eligible individuals to treat and prevent HIV. Unfortunately, it was not intended to be a source of funding for organizations to deliver services, and that’s what we’re trying to reset a little bit.

So the changes to our program model will protect our ability to be able to do this in the longer term and make it a sustainable program for us and more importantly, for patients. So that’s the patient assistance program on that front. The question you’re asking me about PrEP, we’re actually quite encouraged with the FAQs that came out from the U.S. PSTF.

The — and here’s why. In the FAQ, they provide a lot more clarity than they had in the past, right? This isn’t new. The recommendation actually came out, the Affordable Care Act recommendation came out two years ago. But what this provided was actually more details to it and clarity on the importance of PrEP in ending the epidemic and minimizing the barriers of use.

And there’s a couple of things in the FAQ that pop out for me. One is it truly supports physician and patient choice. And that’s the piece where generics or nongenerics, right? So Truvada generics or Descovy would then need to be really — the physicians and the patients get to decide together what is the right medicine for which patient. And of course, with the bone and renal safety benefits that Descovy brings, I think this is a great addition to the FAQs.

In addition to that, there’s also some guidance around timely management of the request for this by payers, so to turn it around within 24 hours, which is quite different. than what’s happening today. And then the last piece is $0 of out-of-pocket costs. So I think for patients, this is great news.

And I also think for patient choice and physician choice, this is quite promising as well.

Daniel O’DayChairman and Chief Executive Officer

Ronny, I wanted to make sure we covered your question. Did we understand you correctly? I assume so, Ronny. Great. Well, thank you all very much.

Jacquie RossVice President, Investor Relations

So thank you all for joining us today. We appreciate your continued interest in Gilead and look forward to updating you on our progress.


[Operator signoff]

Duration: 63 minutes

Call participants:

Jacquie RossVice President, Investor Relations

Daniel O’DayChairman and Chief Executive Officer

Johanna MercierChief Commercial Officer

Merdad ParseyChief Medical Officer

Andrew DickinsonChief Financial Officer

Gavin ScottJ.P. Morgan — Analyst

Terence FlynnGoldman Sachs — Analyst

Brian AbrahamsRBC Capital Markets — Analyst

Geoffrey PorgesSVB Leerink — Analyst

Geoff MeachamBank of America Merrill Lynch — Analyst

Umer RaffatEvercore ISI — Analyst

Michael YeeJefferies — Analyst

Alethia YoungCantor Fitzgerald — Analyst

Ronny GalSanford C. Bernstein — Analyst

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A small lender sorts through the rubble of American finances Thu, 11 Mar 2021 08:02:37 +0000 When Andy Posner visited Brandeis University on March 9 to give a talk, professors and students bumped their arms instead of shaking hands. Having previously ignored the coronavirus, he now worried about all the ways the pandemic could upend the world and the shaky finances of his borrowers. Within weeks, Mr. Posner stood right in […]]]>

When Andy Posner visited Brandeis University on March 9 to give a talk, professors and students bumped their arms instead of shaking hands.

Having previously ignored the coronavirus, he now worried about all the ways the pandemic could upend the world and the shaky finances of his borrowers.

Within weeks, Mr. Posner stood right in the middle of the great decimation of American household finances. His small non-profit lender was inundated with loan requests from jobless and cashless people. Hundreds of other borrowers had stopped paying their monthly payments.

“Emotionally,” he said, “it was very devastating.”

Many Americans have spent years barely getting by, going deep into debt to pay for their homes, cars, and other necessities. Nearly a quarter of Americans had no money saved for a rainy day before the coronavirus pandemic, and less than half had more emergency savings than credit card debt, according to surveys.

For those on the fringes of the financial system, lenders like Posner’s Capital Good Fund are a safety net — a place to get an affordable loan to buy a house or car or to cover an unexpected expense. But these community development financial institutions are only a tiny part of the banking system; In total, they have about $222 billion in assets, roughly the size of a regional bank.

Foundations, governments and banks have poured hundreds of millions of dollars into community lenders in recent months to help keep cash-strapped Americans afloat. It is not enough; millions of Americans have lost their jobs and fallen behind on their bills since the country went dark to fight the coronavirus.

Mr. Posner and his 30-odd Capital Good Fund staff watched America try to make ends meet in real time. Since mid-March, lender Providence, RI has given hundreds of borrowers a break on their monthly payments. He’s given loans to hundreds more — $300 here, $1,000 there — the money needed to keep the lights on in the absence of a paycheck.

For Mr. Posner, the crisis revealed a weakness in the American financial system: the overwhelmed American consumer. A debt burden that seemed manageable when everyone had a job became unbearable within weeks. Many of these obligations are suspended for the time being. Meanwhile, unemployed Americans are falling further behind.

“Americans don’t want to admit how precarious their financial situation is,” he said.

Mr. Posner founded Capital Good Fund in 2009, when he was 24 years old. In its 11 years, the company has granted nearly $11 million in loans and nearly went bankrupt three times in the process.

At the start of the crisis, Capital Good Fund had a year’s worth of cash, which put it in a good position to weather the pandemic. A recession, Posner said, is when companies like his prove their strength to donors and customers.

On March 19, the company launched a program to provide crisis loans to cash-strapped people. A day later, he told his nearly 2,000 borrowers they could defer payments for up to three months, no questions asked.

Mr. Posner works from his home office in Dedham, Mass. “Americans don’t want to admit how precarious their financial situation is,” he said.


Kayana Szymczak for The Wall Street Journal

Kevin Smith saw the payment deferral email and called to request a break on his Capital Good Fund car loan. His consulting business in Miramar, Florida, was struggling during the shutdown. Her son lost his job as a personal trainer and her daughter lost her part-time job at a game room.

Mr. Smith has opted to pay interest only for the time being, bringing his monthly payments down to $76 from $298. He plans to catch up on missed payments at the end of the loan.

The crisis was a rude awakening for Mr Smith’s family of seven, who moved to the US from Africa in 2016. In good times, his steady income helped cover loans on three cars, including a BMW X5, and the occasional Friday dinner.

Now groceries should come from Target or Walmart instead of Whole Foods. Mr Smith has listed some of his cycling gear on eBay and listed his son’s leather jackets on Poshmark to raise funds. He maxed out his credit card to cover bills, dropping his credit score to around 590 from 640.

“I said, ‘This is where we are,'” he said. “You build a lifestyle around an income.”

Capital Good Fund aims to build a loan portfolio of $100 million by 2024; it currently has about $5.3 million. The crisis loan program would be one way to achieve this. The small loans, offered for amounts between $300 and $1,500 at an interest rate of 5%, could be used for almost anything. Reimbursement does not begin for three billing cycles.

Applications poured in. Homebound employees struggled to balance work and childcare. An employee was cursed by a woman who was rejected for a loan. Appellants confused Capital Good Fund with Capital One Financial Corp.

the for-profit bank.

In March, Mr Posner’s Capital Good Fund announced to its roughly 2,000 borrowers that they could defer payments for up to three months. He had a lot of takers.


Kayana Szymczak for The Wall Street Journal

Leonor Tavarez had been a loan officer at the fund for barely a month when she started working from her home in Providence. Her mother, who lives downstairs, has moved up one floor to help care for Ms Tavarez’s seven-year-old daughter. Ms. Tavarez homeschooled her daughter while communicating with clients about their loan applications.

“There was a lot of concern in their voices, not knowing if they would be approved for the loan,” Ms Tavarez said. “I brought a client to tears because she was so upset and worried about her health and future income.”

Michele Hamed contacted the company in early April after her adult son found out about the online loan scheme. Her income dried up in March when the restaurant where she served closed its dining room. His son, a cook in the same restaurant, did not work either.

With two young children also living in their home in Jacksonville, Florida, their finances immediately took a turn for the worse. They ate ramen noodles and bought canned food and cereal from food banks. They drove as little as possible. They loaded toilet paper from the restaurant. “We’re not even middle class,” Ms. Hamed said. “We basically check live to check.”

She received a loan of $1,500 from the Capital Good Fund and her son received $500. They used the money to pay their rent and car loan and buy groceries while they waited for unemployment and stimulus checks to arrive.

On April 7, Capital Good Fund sent another reminder email regarding payment deferrals. The company had already halted payments on nearly 10% of its $5 million in outstanding loans. Mr. Posner predicted that this share could climb to around 15%.

Grant money was pouring in from foundations and banks, but Posner was worried. Many of its donors appeared to be advancing funds that had been earmarked for next year. That likely means less funding in 2021, and it’s not sure the crisis will be over by then. “I think it’s going to be terrible,” he said.

Low-cost loans are another way for nonprofit lenders to fund themselves. With interest rates close to zero, Mr. Posner and his board decided in mid-April that it was time to borrow more. “We want to suck in as much money as possible,” Posner said.

The Capital Good Fund granted 168 loans in April, surpassing its previous monthly record of 143. Most were crisis loans.

Mr. Posner continued to receive more and more requests for help, some from local governments. Could he set up a loan program to help people at risk of losing their health insurance? Could it help people threatened with eviction from social housing?

He had always thought of the Capital Good Fund as a place where people could come and improve their finances. But lately, it’s been like a food bank, handing out small loans that, like a bag of groceries, wouldn’t go very far in a crisis whose effects could linger for years.

“The nonprofit system has never been able to solve all the problems we have,” he said. “But at this point it starts to seem almost futile.”

As of Friday, the company had issued 273 crisis loans. Additionally, 240 borrowers had deferred payments on approximately $792,000 of loans, or 15% of the company’s portfolio.

The company had decided not to send a third notice to remind its borrowers that they could defer payments. Mr. Posner did not want to advertise the option to people who did not need it.

In the coming weeks, many of its borrowers will have to start repaying their loans or ask to extend the deferral. The hope is that they will be on a more stable footing. But companies have continued to lay off millions of workers and much of the economy remains shut down. Many jobs may disappear forever.

Capital Good Fund has increased its reserves against potential losses to 7% of the portfolio, compared to 4% before the pandemic.

Mr Posner is informally budgeting for borrowers to default on 15% of the company’s crisis loans. The company will suffer no loss as long as two-thirds of its borrowers get out.

“It all depends on whether people can go back to work, and I just don’t know,” he said.


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Uncertainty and change focus the norm for theaters as pandemic lingers Thu, 11 Mar 2021 08:02:37 +0000 Des Moines Performing Arts, which is based at the Des Moines Civic Center, has cut staff, moved some programming to virtual platforms and suspended live shows due to the coronavirus pandemic. File photo Seven months after closing due to the coronavirus pandemic, venues such as Des Moines Performing Arts and Hoyt Sherman Place remain closed […]]]>

Des Moines Performing Arts, which is based at the Des Moines Civic Center, has cut staff, moved some programming to virtual platforms and suspended live shows due to the coronavirus pandemic. File photo

Seven months after closing due to the coronavirus pandemic, venues such as Des Moines Performing Arts and Hoyt Sherman Place remain closed for live performances, prompting cost-cutting measures and temporary changes to their mission.

However, the Des Moines Playhouse is moving forward with plans to reopen for live shows this weekend to capacity-limited audiences.

The Des Moines Playhouse relies primarily on volunteer performers and staff to put on a show, while Des Moines Performing Arts and Hoyt Sherman must generate revenue to pay full-time performers and support staff to put on a show, whether it’s a concert or a Broadway show. Show, which can cost between $300,000 and $400,000 per week so far.

The Playhouse held four cinema-style performances in its parking lot over the summer. Now, with that experience under their belt, Playhouse reps are moving forward with two shows starting this weekend, taking place on alternate weekends, with limited seating following COVID-19 protocols listed on their website.

The opening night of each production will be broadcast live for those who do not wish to attend in person.

The opening night of “Weekend Comedy” will air live on October 9, and “I and You” will air live on Friday, October 16. Links to purchase the live streams are available on the Playhouse website and Facebook page.

David Kilpatrick, executive director of the Des Moines Playhouse, said lessons learned at summer drive-ins and audiences’ need to be entertained inspired his staff to begin production on the two fall shows.

But it’s been hard to get there, said Kilpatrick, who acknowledged the Playhouse doesn’t face the same financial challenges that big, for-profit venues face.

“Unlike professional theaters, we only pay a very small handful of people, so we don’t need to earn a specific amount of money to pay our salaries and make the show profitable, he said. “We can keep our costs pretty low, so if our audience is smaller, we’re doing well.”

Even if only a fraction of the seats are occupied, it allows an audience to gather to enjoy the experience together, Kilpatrick said.

Prior to COVID-19, the Playhouse had 63 paid staff and a budget of $2.1 million. Today, its projected budget for the current year is around $800,000 with only 11 employees.

Of this budget, approximately $250,000 is dedicated to ticket sales.

“And that’s if we convince enough people to come to the theater,” Kilpatrick said. “So, you know, it’s basically about 30% of what it was before.”

The Playhouse was forced to cancel all of its spring and summer programming. She received a loan of $187,000 through the Payroll Protection Program, which allowed her to create the driving shows of the summer.

At the start of the pandemic, all Playhouse staff were furloughed. Staff members returned at the end of March when the PPP loan arrived. Meanwhile, all benefits continued to be paid, Kilpatrick said.

“During the summer, because we were doing shows but we didn’t need the teachers, for example, or the director of teachers, we couldn’t use all the technicians we had, we put them on again furloughed, but we maintained their benefits for them,” he said.

Plans are underway for summer and fall productions in 2021, but nothing will be announced until specific times can be assured, Kilpatrick said.

“We don’t want to offer something and then have to cancel or withdraw it, he said.

Unlike the Playhouse, Hoyt Sherman Place and Des Moines Performing Arts have not resumed live performances, leaving the two heavily reliant on donors — and shifting priorities.

Robert Warren, executive director of Hoyt Sherman Place, said the theater lost 80% of its revenue due to its inability to hold live events.

He said that under current social distancing requirements, only 310 of the theatre’s 1,252 seats could be filled, and that’s not enough to be profitable, either for the theater or for the artists it brings in. . Often these artists have a guarantee of $30,000 for $50,000, Warren said.

“That’s not possible for new shows, but also anyone we had on our books that didn’t want to cancel and wanted to get new dates and move on,” Warren said. “How do you cancel the sale of 500 tickets? If we do reopen we will have to uninvite more than half of the public, and it’s a decision our board and staff have thought, when we can safely reopen at greater capacity, we will be ready to do so.

He said membership renewals have remained steady during the pandemic and the theater has received some small loans through the Small Business Administration, as well as emergency funding through the Business Department. cultures of Iowa. Hoyt Sherman also received a $165,000 PPP loan.

Since July 1, continuous furlough has been in place for all staff, he said.

“We decided that we would all like to share in the difficulties rather than eliminating or firing people,” Warren said.

Staff take a day a week or a week off each month to “soften the blow”, he said.

“Right now we kind of plan after the first of the year to be able to start hosting events again.” But the board and staff have decided “that until December, it’s just not really safe to come together with the spikes (in COVID -19) that are still happening,” Warren said.

In the absence of live events, Hoyt Sherman staff focused on the mansion restoration and renovation projectwho received $350,000 in historic state tax credits and a $100,000 donation from the Dahl Trust.

“We realized we had about half the money. We had time out. We could do the demolition work, and we don’t do that around big events in theater, so we just decided to move forward as quickly as possible,” Warren said.

According to a press release, this work should be completed by the end of 2020.

For Des Moines Performing Arts, uncertainty about when shows will be able to resume has resulted in the layoff of 300 part-time employees and full-time staff reductions, said Jeff Chelesvig, president and chief executive officer.

Those cuts will leave the performing arts center with about 25 people, about half of what it was, with everyone else also taking pay cuts, he said.

The venue is now focusing on virtual programming, Chelesvig said.

All summer programming for young people was done virtually this year. Work is also underway to create virtual programs for the center’s Applause program, an educational program for K-12 students that is based on the curriculum and takes place during the school year. The program typically serves about 50,000 in-person students, Chelesvig said.

Des Moines Performing Arts will also continue its involvement with the Iowa High School Musical Theater Awards program, some of which will transition to virtual experiences, he said.

“We will also be running many workshops for students and teachers on topics such as staging and stage design, stage design, all the elements that go into creating a musical, and so on. is something we can also do virtually,” says Chelesvig.

Then there are things to explore, like using the space for weddings and other events, he said.

“The main thing is to try to make sure that everything we do is safe, not only for the participants, but also for our team members,” Chelesvig said.

He said Des Moines Performing Arts was tapping into reserve funds and relying on donors to make ends meet. He also received paycheck protection funds, which ran out in July.

“But in the absence of any state or federal support, we are relying on reserves and donors, and reducing spending as much as possible,” he said.

Chelesvig and Warren said they’re closely monitoring what’s happening not just across the country, but around the world to see what works and what doesn’t when theaters reopen.

“There have been a few attempts to do in-person performances in the UK, which I think hasn’t worked out as well as they had hoped, and nationally we’re just trying to ‘get a sense of how things are going,’ says Chelesvig.

Des Moines Performing Arts has two shows on hold from its 2019-20 season, with single performance tickets and season tickets sold out. There are seven performances for the 2021 season, with only season pass tickets being sold.

“These dates we keep moving,” Chelesvig said. “We don’t think it’s beneficial for anyone to announce dates until we’re absolutely sure they’ll be firm.

“We are planning things, but it’s an ever-changing target.”

With uncertainty dominating Des Moines Performing Arts and Hoyt Sherman, the Playhouse is moving forward with its fall shows and taking precautions to keep its limited audience safe.

Only 120 seats of the 412-seat theater will be sold. Two seats on either side of a group will be empty, with every other row remaining empty. The theater is open an hour earlier to keep people from congregating in the lobby. Concessions are kept to a minimum and intermissions have been eliminated. Masks will be required and temperature checks will be available. Between performances, the theater will be fogged and sanitized, Kilpatrick said.

“All of these practices are all from our summer experience,” he said. “And they worked so well over the summer that we said, ‘That was a success, so let’s continue that process. So we consider summer as our experiment on how to do fall.

Hoyt Sherman Place has implemented rolling holidays and refocused its efforts on restoring the historic mansion that adjoins the theater while waiting for live shows to return. File photo

Can fintech fill the Asian SME lending gap? – Bank Thu, 11 Mar 2021 08:02:37 +0000 October 20, 2016 By Sean Crehan Perhaps no sector has more to gain from fintech innovations than the financing of small and medium-sized enterprises (SMEs), particularly in Asia. SMEs accounted for 42% of Asia’s GDP in 2014, but received only 18.7% of bank loans according to the Asian Development Bank. In particular, Fintech can take […]]]>

By Sean Crehan

Perhaps no sector has more to gain from fintech innovations than the financing of small and medium-sized enterprises (SMEs), particularly in Asia. SMEs accounted for 42% of Asia’s GDP in 2014, but received only 18.7% of bank loans according to the Asian Development Bank. In particular, Fintech can take advantage of the rapid growth of e-commerce and regional trade in Asia, trends that complement the development of SMEs.

SME financing gaps persist around the world, in both developed and developing economies. Among the many factors limiting lending to the SME sector are the limited availability of small business credit ratings, the lack of tangible assets as collateral, and the high costs of providing small loans for lenders.

Alternative Data Fills Gaps in SMB Credit History

A typical constraint for small business financing is the lack of traditional indicators used to inform a credit score or, in some cases, the absence of comprehensive national databases with sufficient history to accurately measure credit risk. . A small business may simply not have a borrowing and loan repayment history. Fintech-facilitated lending may have greater potential for small businesses in Asia, as data sources captured by non-financial businesses can support credit risk analysis even when domestic credit bureaus are still limited, like in countries like China and India.

For example, lenders could use data on a potential borrower’s sales and payment activity from e-commerce companies like Alibaba in China or Rakuten in Japan to assess the borrower’s ability to repay a loan. Indeed, Alibaba directly uses payment data from Alipay to support the activities of its subsidiary Ant Financial. Lenders also use data from service providers such as utilities and telecommunications companies to confirm whether a borrower has a history of paying bills on time. A lender can also substantiate the basics of a loan application more quickly and cost-effectively, for example by verifying the location of a small business using geolocation data obtained from the lender’s telecommunications company. ‘entrepreneur.

If the use of these alternative data sources accelerates, Asia may be able to leverage fintech to move beyond the requirement for a strong bank-led national credit bureau, at least for small businesses and consumers. Indeed, Ant Financial’s Sesame Credit is a new rating agency trying to do just that.

Regulatory Implications of Alternative Data

There are a number of regulatory and legal concerns regarding the use of alternative data sources by lenders. Among the most important considerations are customer protection and privacy: laws, regulations and oversight must ensure that data is used with customer consent and, just as importantly, does not promote improper processing. discrimination in funding decisions. Even a well-meaning fintech lender can use alternative data in ways that have disparate and negative impacts on certain populations like low-income households.

The use of alternative data from non-financial firms, especially those with market power, could also raise competition and antitrust issues. Traditionally, national credit bureaus share credit scores with other financial institutions, but the development of alternative sources of scoring could encourage dominant players to create closed networks with data access limited to their own fintech affiliates. which would undermine the network effects needed to boost SME financing. The best approach will invite all stakeholders to share and collaborate in a more robust national credit scoring system that incorporates both traditional and alternative data.

Even though lenders can use fintech to improve credit risk management, in much of Asia they will still have limited recourse to seize assets if loans go bad, a challenge facing confronted even traditional financial institutions. The dynamic has encouraged some unscrupulous fintech companies to use alternative forms of collateral. For example, loan sharks operating on Jiedaibao, a popular Chinese P2P platform, used embarrassing photos of some borrowers to secure loan repayments, with the right to share the photos publicly if the borrower defaulted.

Technology can enable trade finance for SMEs

Fintech can also provide trade finance services to small businesses, which have historically had more limited access. Trade is extremely important for the growth of small businesses in Asia, where substantial regional trade combined with the digitalization of trade greatly expands their potential market. The Bank for International Settlements estimates that around a third of global trade, or $6 trillion, is supported by trade finance. In Asia in particular, this activity is dominated by banks, which tend to serve large corporations given the cost and complexity of the existing processes for granting international letters of credit, providing liquidity in foreign currencies and verifying that a transaction has been completed in accordance with the contract.

Yet much of this complexity stems from the simple fact that trade finance remains remarkably old-fashioned. For example, the continued use of paper letters of credit can lead to significant delays in the settlement of cross-border trade. Digitizing these processes doesn’t require fintech companies, but they can be more nimble, with reduced overhead, streamlined online processes without legacy paper-based systems, and alternative data sources that allow them to serve smaller businesses more efficiently at lower cost than traditional financial service providers.

Instead of simply digitizing old processes, the use of blockchain technology, for example, could dramatically streamline trade finance, eliminating middlemen who previously verified that a shipment was delivered to a given destination. Instead, the shipment’s arrival could be verified with geolocation data, which would automatically execute a smart blockchain contract, transmitting payment to the seller. The entire process could take place in a fraction of the time currently required. For small businesses with significant liquidity constraints, reducing the time between sale and payment can be the difference between growth and bankruptcy.

A virtuous circle for SME financing

Fintech can improve the accessibility, convenience and cost of financing for SMEs around the world. Small Asian businesses could particularly benefit from the growth of regional trade and e-commerce, areas where fintech has the potential to have a major impact. Over time, SMEs could begin to receive a share of loans commensurate with their contribution to the economy.

In the long term, improvements in SME financing could even transform regulators’ views on the risks of the sector. Regulations can affect SME loans both in terms of accessibility and cost. If fintech can increase the sophistication of SME credit analysis and thereby reduce the expected risk of associated loans, regulators might feel more comfortable relaxing rules related to SME financing, thus magnifying the benefits of innovation.

Opinions expressed in Asia Program publications do not necessarily reflect the views of the Federal Reserve Bank of San Francisco or the Board of Governors of the Federal Reserve System. All Asia Program content (audio, text, photographs, graphics and videos) is copyrighted. Permission to reprint or reuse content must be obtained in writing.

RBI to fine tune bank loans for rooftop solar panels in India – Quartz India Thu, 11 Mar 2021 08:02:37 +0000 India’s target to increase solar capacity by 100 gigawatts (GW) is set to face serious challenges if the current slow growth in rooftop solar is not addressed. Of the overall target, it is proposed that 40 GW come from the rooftop solar segment. However, capacity to date remains at 4 GW. To meet the 2022 […]]]>

India’s target to increase solar capacity by 100 gigawatts (GW) is set to face serious challenges if the current slow growth in rooftop solar is not addressed. Of the overall target, it is proposed that 40 GW come from the rooftop solar segment. However, capacity to date remains at 4 GW. To meet the 2022 target, there must be a capacity addition of 9 GW each year from now.

This is a big ask for an industry plagued by limited consumer awareness and challenges related to intra-governmental coordination, institutional priorities and cumbersome processes. Also, the lack of customized financing options is a major impediment to the integration of rooftop solar in India.

Good loans, bad terms

In 2015, to encourage the adoption of lending in renewable energy, including solar rooftops, the Reserve Bank of India (RBI) included the sector in the Priority Sector Lending (PSL) standards. In line with the standards, renewable energy loans of up to Rs10 lakh ($14,497) for individuals, and up to Rs15 crore for other categories (such as small and medium-scale commercial and industrial categories), have made available to facilitate the adoption of small and medium enterprises. valued loans. This move was aimed at creating a market and facilitating renewable energy projects for residential and non-residential users in India.

In this scenario, when a residential consumer approaches a bank for a rooftop solar loan, it is provided as a “stand-alone” loan or as an “add-on” to an existing loan for the improvement of the habitat. However, an analysis of the loan programs offered by major Indian banks revealed three issues related to the interest rates and collateral they needed for approval.

First, the interest rates offered to customers were higher in the stand-alone and complementary loan cases. If a customer applies for a stand-alone solar loan, the interest rate can vary between 9.3% (for Punjab National Bank) and 16% (for IDBI Bank), which is usually higher than add-on loans. The top-up loan itself is often renegotiated at higher interest rates compared to existing home improvement loan rates. Thus, in both cases, loans for a solar project often turned out to be more expensive than other loans.

Second, loan terms for solar rooftops are largely uniform across the country and do not take into account relevant regional variations – for example, in electricity tariffs, net metering rates or financial settlement mechanisms – which creates different cost structures and reimbursements. periods.

These universal standards for assessing loan applications could make them unattractive to some customers, as they tend to peg their calculations back to electricity tariffs, to arrive at the net savings they will enjoy (in the future) after the installation of solar energy, which forms the basis for the decision to install solar panels on the roofs. Tailoring loans appropriately, based on electricity tariffs and the monetized value of savings from exporting excess units of electricity to the grid, could make this a more viable option.

Finally, most banks require loan seekers to mortgage their home as collateral, which often proves counterproductive as interested customers see this as a disproportionate demand. The loan for renewable energy projects is usually a few hundred thousand rupees, while the value of their house could be several times higher.

A step back

Recently, RK Singh, the Minister of State (Independent Charge) for Electricity and New and Renewable Energy, called for the removal of the PSL limit for the renewable energy sector. This means that the limits that facilitated small loans for renewable energy under the PSL standards would end, opening the sector to larger loans. This decision could potentially dry up lending to the residential segment for renewable energy.

When the RBI included renewable energy in the PSL scheme, its main objective was to ensure financial inclusion, so that small-scale renewable energy projects, hitherto considered an unattractive lending option, obtain adequate funding to achieve the national goal. In the specific context of the residential solar sector, small loans had the potential to boost the sector, provided the process was not cumbersome and the interest rates were attractive.

To achieve the target of 40 GW of residential rooftop solar power by 2022, the government should try to promote rooftop solar power to as many potential households in the country as possible. An accessible financing model is an important prerequisite for the successful adoption of large-scale rooftop solar. The RBI’s policy on PSL could have been an important first step towards this goal.

Go forward

Under current policy, the existing central government subsidy and customized financial options based on electricity tariff and net metering benefits could help determine a modest interest rate for rooftop solar loans.

As the residential rooftop solar segment is a diverse market, lending to this sector needs to be redesigned with the unique characteristics of the product in mind. An inclusive and well-designed lending program, along with ease of access, simple and innovative assessment processes, and the maintenance of PSLs could attract interest from residential energy consumers and go a long way in accelerating demand. renewable energy in India.

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The Football Referees Corps grants small loans to its members Thu, 11 Mar 2021 08:02:37 +0000 Referee (Photo credit: ISL) The Bombay Referees Association has given loans of Rs 5,000 each to its seven members to help them cope with the coronavirus crisis. PTI Last update:April 16, 2020, 6:46 p.m. HST FOLLOW US ON: With referees’ earnings stopped in the absence of football matches in the city, the Bombay Referees Association […]]]>

Referee (Photo credit: ISL)

The Bombay Referees Association has given loans of Rs 5,000 each to its seven members to help them cope with the coronavirus crisis.

  • PTI
  • Last update:April 16, 2020, 6:46 p.m. HST
With referees’ earnings stopped in the absence of football matches in the city, the Bombay Referees Association has granted loans of Rs 5,000 each to its seven members to help them cope with the crisis, triggered by COVID-19.

A referee usually earns an average of 300 to 500 rupees per game in an organized league tournament and in private league games the amount is around 1500 rupees per day.

Shirzad Bhatena, the charity’s treasurer, told PTI, “We were able to help seven members and donated 5,000 rupees per person.”

According to Bhatena, the amount that was distributed is the amount of interest they receive on the charity fund they have.

Explaining the decision to give the money as a loan, Bhatena said: “If you don’t say it as a loan, anyone and everyone will show up. So we wanted to help people who are really in need. Nine people had applied but we selected seven.

The private body, formed in 1947, has approximately 100 members.

Bhatena, who is also a match commissioner at the Football Association of India, said the referees had given them in writing that they would refund the amount when matches resumed after the lockdown period ended.

What China’s crackdown on online microcredit means for fintech giant Ant Group Thu, 11 Mar 2021 08:02:37 +0000 Chinese financial regulators have drafted rules that clamp down on a booming microcredit market in the world’s second-largest economy, a move that could dampen the profits of the country’s fintech giants and stem the flow of funds to small businesses. The release of the consultation paper on Monday coincided with a meeting between China’s financial […]]]>

Chinese financial regulators have drafted rules that clamp down on a booming microcredit market in the world’s second-largest economy, a move that could dampen the profits of the country’s fintech giants and stem the flow of funds to small businesses.

The release of the consultation paper on Monday coincided with a meeting between China’s financial regulators, led by the relatively conservative People’s Bank of China (PBOC), and senior executives from Ant Group, the largest online banking service provider. microfinance in China.

“This is a strong signal of regulatory tightening,” Shujin Chen and Alfred He, equity analysts at Jefferies, said in an investor report.

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The proposed rules could block the flow of cash to the parts of the economy that need it most. China is recovering from the economic pain inflicted by coronavirus-related lockdowns this year, but small business owners and individuals are still struggling to get loans from traditional banks.

As regulators seek to reduce debt in the financial system, the draft rules could also reduce profits for microlenders by increasing compliance costs, reducing the size of individual loans and requiring online platforms to contribute. a larger share of lending instead of relying on traditional lenders. ‘ balance sheets, according to analysts.

Jack Ma at the Bund Summit 2020 in Shanghai on October 24. Photo: Weibo

True, regulators could still revise the rules. Smaller competitors might not be able to afford the higher compliance costs and could be left behind. There were 7,227 microfinance companies in China with 902 billion yuan ($135 billion) in loans outstanding as of September 30, according to PBOC data.

Jack Ma, the Chinese billionaire who co-founded Ant and controls 50.5% of its voting rights, said on October 24 that traditional lenders were run like “pawnbrokers” because banks always require collateral before lend. Going forward, he said, lending decisions should be decided by big data analytics.

A central part of Ant’s strategy is to earn fees by providing a digital platform for banks to reach small borrowers and more accurately price credit risk. It is set to make its commercial debut in Shanghai and Hong Kong in the world’s largest initial public offering, after winning approval from regulators last month. He flagged changing regulations as a risk for potential shareholders.

The PBOC's Yi Gang pays attention to commercial banks’  reliance on technology companies' risk management systems.  Photo: Bloomberg

PBOC’s Yi Gang pays attention to commercial banks’ reliance on tech companies’ risk management systems. Photo: Bloomberg

Yi Gang, the PBOC governor, said in a panel discussion at a financial technology summit in Hong Kong on Monday that innovation from big tech companies has made microloans possible in the Chinese hinterland. . “It’s a huge improvement,” he said. Yi also said that the PBOC has noticed that commercial banks use the services of Big Tech companies to find customers and depend on them for risk management.

Regulators met with Ma, Ant executive chairman Eric Jing and chief executive Simon Hu on Monday, according to the securities regulator. The meeting also included representatives from the China Banking and Insurance Regulatory Commission (CBIRC), the China Securities Regulatory Commission and the State Administration of Foreign Exchange, the foreign exchange regulator.

They discussed the health and stability of the financial sector, and Ant will implement the meeting’s advice in depth, according to a company spokesperson.

Ant’s management compares China’s banks to the arteries of the economy, and Ant to the capillaries that send funds to its ends – small businesses and individuals. The company’s personal and small business lending division generated 39.4% of its revenue in the six months ended June 30.

Ant issues loans, 98% of which are then guaranteed by financial institutions or securitized. As of June 30, he was working with around 100 banks.

Loans granted by banks via online platforms reached 1.43 trillion yuan on June 30, according to the PBOC, or 22 percent of personal consumer loans excluding mortgages and credit card loans.

Lufax made its trading debut on Wall Street on Friday.  Photo: Reuters

Lufax made its trading debut on Wall Street on Friday. Photo: Reuters

The draft rules state that large online microcredit companies will be overseen by central regulators, including the PBOC and CBIRC, instead of local offices, suggesting more frequent reporting and monitoring of loans, analysts said.

The rules also prohibit regional banks from lending outside their provinces through online platforms. These banks are likely the biggest users of online microcredit companies and have been keen to use digital platforms to find borrowers outside their region, analysts said.

The draft rules also cap loan amounts at 300,000 yuan for each person and 1 million yuan for businesses. This rule could have less impact on companies in Ant, Huabei and Jiebei, which provide small loans. Smaller rivals that provide larger loans, such as New York-listed Yiren Digital, could be hit harder. Yiren Digital did not immediately respond to a request for comment.

Lufax, Ant’s smaller rival, began trading in New York on Friday. Loans funded by microcredit affiliates represented less than 1% of the total loans Lufax facilitated in the nine months ended September 30. All microloans funded during this period were funded without any co-lending or loan-facilitating funding partners. He said he did not expect the draft rules to have a significant impact on his business operations.

The rules also require online platforms to contribute at least 30% of loans, rising from 1% to 20%, and loans cannot be used to invest in financial markets, real estate or to pay off mortgages.

Online platforms will have at least a year to comply with the new rules.

Ma said Beijing’s emphasis on “preventing systemic financial risks” was wrong. “Innovation always involves risk. There will be no innovation without risk… the biggest risk is that you try to minimize the risk to zero,” he said.

A third of the shares of Ant Group are held by South China Morning Post parent Alibaba Group Holding.

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San Francisco crowdfunder Kiva creates credit database in Sierra Leone Thu, 11 Mar 2021 08:02:37 +0000 (This August 21 story corrects to make it clear that Kiva is a nonprofit, not a charity, paragraph 1.) (Reuters) – Kiva, a San Francisco-based nonprofit tech organization, is using blockchain to create an online ID database in Sierra Leone that allows people struggling to get loans to prove their credentials credit. Kiva and President […]]]>

(This August 21 story corrects to make it clear that Kiva is a nonprofit, not a charity, paragraph 1.)

(Reuters) – Kiva, a San Francisco-based nonprofit tech organization, is using blockchain to create an online ID database in Sierra Leone that allows people struggling to get loans to prove their credentials credit.

Kiva and President Julius Maada Bio officially launched the system in the capital Freetown on Wednesday. Bio hopes this will draw more Sierra Leoneans into the financial system.

Kiva facilitates small loans in 80 countries, but Sierra Leone is the first country to implement an online credit system designed by the organization.

“This visionary step here today ensures that Sierra Leoneans are not excluded from…the global digital economy,” Bio said at the launch.

More than three-quarters of Sierra Leone’s population live outside the formal banking sector, according to central bank data. Informal institutions such as community banks and microfinance lenders are more common, but they rarely share credit information and often charge exorbitant interest rates.

The platform will allow lenders to view citizens’ credit history using fingerprints and other biometric data collected a few years ago by the government of Sierra Leone to print voter ID cards .

Ordinary Sierra Leoneans seem excited by the prospect, including Safiatu Mariama Bangura who, together with her mother, runs a rice restaurant in an aluminum shack with tarpaulin walls in the capital Freetown.

“It’s very difficult to do business because we don’t have a bank account or any way to get loans,” Bangura said. “[The program] would help us, because my mother can’t even sign her name – she only knows how to use her fingerprint.

Each potential borrower will be assigned a digital wallet, with transactions recorded on the blockchain to secure user information and prevent slight tampering.

“A national identity program here would provide the foundation for growing a robust financial services ecosystem,” said Schan Duff, Kiva’s vice president of strategy.

Borrowers will access the wallet through an app. This poses a problem for many in Sierra Leone, where the Ministry of Information says less than 15% have internet access.

Duff said its partners on the ground, including banks, are overcoming this problem by using mi-fi devices that can connect to the internet through telephone networks.

The government of Sierra Leone aims to have the system in use by all banks and microfinance institutions in the country by the end of this year, Bio said.

“Lack of identification, or the inability to verify that identification for credit purposes, increases the cost of doing business for everyone,” David Sengeh, who heads the Science Directorate, told Reuters by phone. technology and innovation from Sierra Leone.

“A national platform…means that businesses, institutions and anyone can verify that what I say about my loan history is (true). Anyone can fake a driver’s license, but not a system like this.

Editing by Tim Cocks and Alexandra Hudson