The JP Morgan Healthcare Conference reconvened for its final full day today in San Francisco – while the weather was not quite as balmy, Union Square still teemed with investors in pinstriped suits, Blue Bottle (and Starbucks) cups and iGadgets in hand. People clearly LOVE sitting outside in Union Square in these temps – this was great to be among them. Along with a fascinating keynote address by Dr. Condoleezza Rice (how often does one have the chance to learn about terrorism and geopolitics at a healthcare conference?), day #3 featured more packed presentations from some of the biggest names in diabetes. See below for our top ten highlights from the day, including Insulet’s take on the best marketing strategy, regulatory updates from BD and AZ, and resounding appreciation for MannKind’s Mr. Al Mann. Don’t forget to check out our days #1 and #2 reports for highlights from the first two days of the conference, which wraps up Thursday morning with presentations from Vivus and Neurocrine.
1. Insulet’s new CEO Mr. Patrick Sullivan emphasized the need to spend much more on sales/marketing (especially to doctors/payers), the huge upside of the drug delivery business, and a goal to make Insulet a $1 billion company by 2019.
2. BD CEO Mr. Vince Forlenza provided an updated timeline for the FDA clearance of the company’s first-generation insulin infusion set (“late 2015”) – however, it remains unclear whether the device has yet been submitted to the Agency.
3. AstraZeneca confirmed that its saxagliptin/dapagliflozin fixed-dose combination (FDC) has been submitted to regulatory authorities, consistent with guidance for a submission by the end of 2014.
4. Arena provided more details on Eisai’s new marketing initiatives for Belviq (lorcaserin) and offered a more concrete timeline for the drug’s once-daily extended-release formulation.
5. Resverlogix highlighted the striking 77% reduction in MACE (p=0.01) in diabetes patients seen in a post-hoc phase 2b analysis of its epigenetics-based RVX-208; real results are almost certainly more modest, but the compound is worth watching.
6. An absolutely packed standing-room-only audience gave MannKind’s Mr. Al Mann multiple rounds of applause in recognition of his storied career and triumph with Afrezza; MannKind believes Afrezza’s post launch trajectory will start modestly but pick up speed after a few quarters.
7. With the SGLT-1/2 dual inhibitor sotagliflozin (LX4211) about to enter phase 3 for type 1 diabetes, Lexicon management discussed how competition in diabetes and FDA policy hindered the past two years of partnership discussions.
8. A panel discussion on the emergence of mobile Apps as Drugs highlighted Welldoc’s BlueStar as a “canary in the coal mine” for how payers are going to view medical mobile technology in coming years.
9. ChemoCentryx’s presentation provided further insight into the company’s plans for its diabetic nephropathy candidate CCX140; a partnership agreement is expected by the end of 2015.
10. NeuroMetrix Senior Vice President Mr. Frank McGillin discussed distribution plans and potential new label indications for Quell, the company’s over-the-counter wearable device for chronic pain.
Top Ten Highlights
1. Insulet’s new CEO Mr. Patrick Sullivan emphasized the need to spend much more on sales/marketing (especially to doctors/payers), the huge upside of the drug delivery business, and a goal to make Insulet a $1 billion company by 2019. A very tense Q&A with investors mostly focused on Insulet’s lower-than-expected 4Q14 numbers: revenue of $71-73 million (vs. an expected $76-81 million), with modest ~15% year-over-year growth in the US business and ~100% YOY growth in the international business. The shortfall was 80% attributed to a delay in the Drug Delivery business (3% of sales), and 20% attributed to US distributors destocking their inventory. Still, it became clear in Q&A that the US business has not been performing as well as previous earnings calls have implied, since patient-add numbers were apparently reported on a consolidated worldwide basis. Indeed, 4Q14 was flat year-over-year for patient-adds, and 15% US growth is quite low for Insulet. On the bright side, US patient adds were up sequentially 5-10% quarter-over-quarter over the course of 2014, meaning the trajectory is positive. Mr. Sullivan reported that Insulet has ~75,000 worldwide customers (up 25% from ~60,000 this time last year), with an estimated ~15% share of the US insulin pump market. Looking to 2015, Insulet expects to add an additional 20 sales reps and to spend an additional $15 million on sales/marketing. There were no major new updates on the pipeline front, though Mr. Sullivan did say Insulet needs to occupy a “meaningful position in the artificial pancreas, where the field is going.” Much more detail and the transcript from Q&A are below.
2. BD CEO Mr. Vince Forlenza (Franklin Lakes, NJ) commented that the company is expecting FDA clearance of its first-generation insulin infusion set in “late 2015.” This is the most specific guidance we have heard to date and suggests that clearance will come at the back end of the timeline provided at F4Q14 (March-September 2015). Indeed, Mr. Forlenza was unclear on whether the device had yet been filed with the Agency. Development of the infusion set has moved significantly faster than the company guided for in early 2014 – F2Q14 put development at “two to four years,” though this was updated in F3Q14 to 24-36 months. Mr. Forlenza now expects commercialization in 2016, when BD will take the product to market both directly and through partnerships. Notably, Mr. Forlenza did not comment on BD’s new pen needle product, the AutoShield Duo (US launch in August 2014), and we hope more granularity on penetration and expectations emerges over time.
- The majority of Mr. Forlenza’s prepared remarks focused on BD’s $12.2 billion acquisition of CareFusion in October 2014. Though it has not yet been finalized, the deal should close by the end of 1Q15. Mr. Forlenza spoke about the acquisition in broad terms, emphasizing that it would allow the companies to align their highly complementary technologies, improve the quality of patient care, and reduce healthcare costs. The implications for BD’s Diabetes Care business remain unclear as CareFusion does not appear to have products that can contribute directly to the segment – the company specializes in technologies designed to reduce medication errors and prevent healthcare-associated infections. That said, we imagine the additional sales force, growing distribution network, and improved economies of scale can only augment the segment’s outlook.
3. AstraZeneca confirmed that its saxagliptin/dapagliflozin fixed-dose combination (FDC) has been submitted to regulatory authorities. This is consistent with guidance from the company’s November Investor Day indicating that “saxa/dapa” would be filed (presumably in both the US and the EU) by the end of 2014, but we had not previously heard official confirmation of a submission. Assuming a standard review cycle, regulatory decisions would likely arrive in late 2015/early 2016. If approved, saxa/dapa would be the first SGLT-2 inhibitor/ DPP-4 inhibitor to reach the European market; Lilly/BI’s empagliflozin/linagliptin FDC should be first in the US with an FDA decision expected as early as next month. We are excited to see these combinations finally close to reaching patients, as they appear to offer unprecedented efficacy for an oral medication (though not the additive or synergistic efficacy that some had predicted, sadly) along with minimal risk of hypoglycemia and the potential for weight loss. We will be most keen to see how the products are priced and whether the companies will offer copay assistance programs comparable to those for the three SGLT-2 inhibitors currently on the market.
- In a “fireside chat” following the presentation, CEO Mr. Pascal Soriot expressed confidence that AZ will weather the storm of increased payer pressure in diabetes and other areas. Mr. Soriot acknowledged that payers have become “more and more demanding” but assured investors that the company has “built that pressure into our plans.” He also noted that the entire market, not just the primary care sector, is being affected by pricing pressure and argued that the key factor is whether companies produce products that are sufficiently differentiated. The competition for formulary contracts certainly is heating up big time in diabetes – see our JPM Day #2 report for more commentary on this issue from Lilly.
4. Arena CEO Mr. Jack Lief provided more details on Eisai’s new marketing initiatives for Belviq (lorcaserin) (regarding the sales force and savings cards) and also highlighted a more concrete timeline for the drug’s once-daily extended-release formulation. During the breakout session, management elaborated on the changes in Eisai’s marketing for Belviq, explaining that the sales force will be reduced from 600 reps to 450 reps (reversing the recent expansion in 2Q14) to solely focus on active prescribers of anti-obesity medications (rather than the previous focus on both active prescribers and non-prescribers). These resources will then be utilized more toward direct response television (DRTV) campaigns, as management explained that more of Belviq’s growth has been driven by patient awareness rather than by the targeting of providers. Notably, while not much detail was disclosed, Arena stated that Eisai will also adjust the savings card offered to uninsured patients to help reduce out-of-pocket payments – this is something we are especially excited to hear as we have heard concerns about the high costs of branded obesity medications (see our coverage of Obesity Week and Cleveland Clinic Obesity Summit). We expect to learn more details later this week from Eisai as reported by Arena’s recent press release. In addition, Mr. Lief highlighted during the company presentation that the results of Belviq’s once-daily extended release formulation studies will be announced in 1Q15 (this is slightly earlier than the company’s estimate of early 2Q15 as reported in 1Q14) and that Arena plans to file an NDA in 2Q15. We are additionally enthusiastic about this new formulation as it could improve patient adherence, although we do wonder how the pricing would be changed.
5. Canadian biotech Resverlogix is looking to bust out on the diabetes scene in a big way, given early evidence of a marked reduction of cardiovascular disease with its BET bromodomain inhibitor RVX-208. CEO Mr. Donald McCaffrey’s presentation at Biotech Showcase focused on the 77% reduction in the incidence of MACE (p=0.01) seen in a post-hoc analysis of diabetes patients in phase 2b. Other smaller clinical trials found MACE reductions on the order of 50%-70%. The findings from these trials are highly intriguing but it is hard to believe that the effect, if it exists, could be that large. Indeed, a cause for caution in interpreting the results is the fact that the 77% statistic was drawn from a post-hoc analysis rather than a prospectively defined endpoint. Although nothing is certain just yet, BET inhibition is an emerging field (related to epigenetics) and some degree of cardiovascular benefit is plausible given that RVX-208 leads to multiple positive effects on lipids, glucose, and inflammation. Over the past year we have been excited to see Resverlogix’s focus swing towards diabetes. RVX-208 will move to a large phase 3 trial called BETonMACE, enrolling a pool of type 2 diabetes patients and with a primary endpoint of a 30% reduction in MACE. Resverlogix may have entered diabetes from left field but based on the clinical results so far, as well as the dire need for any means of cardiovascular risk reduction in diabetes, they strike us as well worth watching.
6. In an upbeat and packed presentation, MannKind’s Mr. Al Mann and new CEO Mr. Hakan Edstrom celebrated Afrezza’s progress and future potential, as well as MannKind’s future beyond Afrezza. For reasons unknown, MannKind was relegated to one of the smaller presentation rooms. It quickly became evident that this was a poor choice, as behind the 40 attendees lucky enough to find seats, another 40 to 50 were crammed into the standing-room-only space by the door. Mr. Al Mann received not one, but four hearty rounds of applause in recognition of his storied career and triumph on Afrezza. We noticed former Sanofi CEO Mr. Chris Viehbacher in attendance. Management assured attendees that the turbulence in Sanofi’s leadership and diabetes portfolio have not damaged Sanofi’s commitment to Afrezza. Mr. Edstrom suggested that Afrezza’s high degree of differentiation could allow Sanofi to pursue a reasonably aggressive pricing strategy even amidst the immense pricing pressure elsewhere in the insulin market. MannKind expects Afrezza’s uptake during the first couple of quarters post-launch to be modest due to the need to familiarize and educate physicians (initially focusing on endocrinologists) about Afrezza; the company expects uptake to pick up speed after the initial education phase. Looking beyond Afrezza, an advisory panel investigating new compounds and disease areas (including GLP-1, pain, and respiratory diseases) is wrapping up its work; findings may be discussed at a MannKind’s analyst day in March.
7. At long last, Lexicon’s SGLT-1/SGLT-2 dual inhibitor sotagliflozin (LX4211) is entering phase 3, though not in the way that was originally planned. CEO Mr. Lonnel Coats proudly announced that phase 3 has begun for sotagliflozin in type 1 diabetes, although the first patient has not yet been randomized (that will happen some time during 1H15). That program will involve two pivotal studies with 750 patients each along with a ~1,400-patient safety exposure study. The meaty discussion during the breakout session focused as much on sotagliflozin’s complicated development path as its current status. Mr. Coats forthrightly suggested that FDA policy is one of the biggest factors keeping sotagliflozin from achieving its maximum potential because it makes phase 3 – especially CVOTs – cost-prohibitive without a partner; he did, however, theorize that policies may become more favorable in the future. He suggested that partnership discussions were also challenging because of increased competition in diabetes, which caused potential partners to take a step back and wait for challenging pressures and trends to stabilize.
- Big-picture, management remains highly confident in sotagliflozin’s potential in type 1 diabetes, suggesting than peak sales of $1 billion may even be a conservative estimate. Mr. Coats asserted that the drug’s appealing clinical profile should merit and earn some degree of a pricing premium. He also suggested that a sales force of roughly 100-120 should be sufficient to market sotagliflozin for type 1 diabetes. We believe Lexicon’s compound could be a huge boon for type 1 diabetes patients, as much through reduced glycemic variability and less weight gain as through A1c improvements. It could have a major impact on the insulin market, as phase 2 results found a ~26% placebo-adjusted reduction in insulin dose with sotagliflozin in type 1 diabetes alongside improvements in A1c. Especially now that the market has proven receptive to selective SGLT-2 inhibitors, we view a bucketed type 1 and type 2 diabetes partnership to be as compelling as ever, though clearly there’s fear out there on multiple fronts (reimbursement, proving economic system benefits, etc).
8. A panel discussion on the emergence of mobile Apps as Drugs highlighted Welldoc’s BlueStar as a “canary in the coal mine” for how payers are going to view medical mobile technology in coming years. Ms. Julie Papanek (Canaan Partners, Westport, CT) acknowledged that Welldoc has established relevance via solid clinical data – a factor seen as critical in achieving app penetration among the panelists – but noted that it is still having some trouble reaching formularies. We would point out that BlueStar initially launched with impressive reimbursement similar to other prescription products from payers such as Ford, Rite Aid, and Dexcom. That said, Ms. Papanek’s implication seemed to be that FDA approval has not provided BlueStar with a “golden ticket” and that obstacles remains despite solid clinical data. Discouragingly, we continue to hear that payer understanding of the value of mobile technology remains low in spite of growing receptivity in the healthcare community. How Welldoc – and other companies looking to enter the digital health space – bridge this gap will be key moving forward.
9. ChemoCentryx’s presentation provided further insight into the company’s plans for its diabetic nephropathy candidate CCX140. The vast majority of the presentation was devoted to the positive topline results from a recent 52-week phase 2 trial of the compound. That study found that treatment with 5 mg CCX140 led to significant reductions in urinary albumin/creatinine ratio (UACR) and an attenuated rate of decline in estimated glomerular filtration rate (eGFR) vs. placebo, both in addition to standard of care. ChemoCentryx President and CEO Dr. Thomas Schall expressed particular excitement about the eGFR results, noting that the improvement appears to be more robust than what is typically seen with currently approved drugs and that measuring eGFR is important in assessing long-term kidney function and provides a basis for phase 3 trial endpoints. ChemoCentryx plans to seek a partner, ideally one with “deep pockets” and “deep expertise in the renal space,” before initiating phase 3 trials; that decision is expected in 2015. Dr. Schall indicated that ChemoCentryx is not looking for a “garden-variety licensing proposition” but hopes to retain control over the compound at least in some geographies. Dr. Schall expressed optimism that a number of qualified companies will be interested given the enormous unmet need in this area – we imagine that several companies in our diabetic nephropathy competitive landscape could be potential candidates.
10. NeuroMetrix Senior Vice President Mr. Frank McGillin (Waltham, MA) provided an overview of Quell, the company’s over-the-counter (OTC) wearable device for chronic pain. Quell uses the same transcutaneous electrical nerve stimulation (TENS) technology as the company’s prescription/reimbursed Sensus device. As we learned at CES 2015, NeuroMetrix intends to launch the device in 2Q15 at a retail price of $249 plus $29.99 for a one-month supply of electrodes. The device will initially be distributed through two channels: physicians offices (“we think professional recommendation is an important part of educating consumers about this new technology”) and NeuroMetrix’s online website. The device pairs with a smartphone app via Bluetooth and will launch with iOS compatibility (Android functionality is in development). Mr. McGillin also highlighted that while Quell currently has an indication for chronic pain management, the company is pursuing a new indication for “balance” in patients with peripheral diabetic neuropathy. NeuroMetrix has completed clinical trials in this population documenting improvements in balance associated with TENS therapy and is hoping to leverage that data into an updated label in the near future.
Detailed Discussion and Commentary
Patrick Sullivan (CEO, Insulet)
Insulet’s new CEO Mr. Patrick Sullivan (90 days into the job) emphasized the need to spend much more on sales/marketing (especially to doctors/payers), the huge upside of the drug delivery business, and a goal to make Insulet a $1 billion company by 2019. A very tense Q&A with investors mostly focused on Insulet’s lower-than-expected 4Q14 numbers: revenue of $71-73 million (vs. an expected $76-81 million), with modest ~15% year-over-year growth in the US business (83% of sales) and ~100% YOY growth in the international business (15% of sales). The ~$6 million shortfall was 80% attributed to a delay in the Drug Delivery business (3% of sales), and 20% attributed to US distributors destocking their inventory. Still, it became clear in Q&A that the US business has not been performing as well as previous earnings calls have implied, since patient-add numbers were apparently reported on a consolidated worldwide basis. Indeed, 4Q14 was flat year-over-year for patient-adds, and 15% US growth is quite low for Insulet. On the bright side, US patient adds were up sequentially 5-10% quarter-over-quarter over the course of 2014, meaning the trajectory is positive. Mr. Sullivan reported that Insulet has ~75,000 worldwide customers (up 25% from ~60,000 this time last year), with an estimated ~15% share of the US insulin pump market. Looking to 2015, Insulet expects to add an additional 20 sales reps and to spend an additional $15 million on sales/marketing. Mr. Sullivan is optimistic for 20-30% growth in 2H15 once the new commercial team gets up to speed; he expressed high confidence in their ability to execute, as they previously worked with him at Cytyc/Hologic and know “what an S.O.B.” he is. There were no major new updates on the pipeline front, though Mr. Sullivan did say Insulet needs to occupy a “meaningful position in the artificial pancreas, where the field is going” – we certainly were excited to hear this.
- Mr. Sullivan was fairly critical of Insulet’s previous leadership, citing an overemphasis on patient marketing to the exclusion of HCPs and payers. He expressed major concern, reviewing the company’s go-to market strategy, especially given the lack of compelling data to share with doctors. We know more data is possible to create now that sensors are better (time in zone data is more possible to put together etc).
- Insulet will add an additional 20 commercial team resources in 2015 (total = 150 field sales reps + managers). The company will also undertake more medically focused peer-to-peer marketing efforts, such as dinner events. To date, Insulet has not implemented such outreach, which proved quite successful at Mr. Sullivan’s previous company, Cytyc. Of course, Medtronic is very strong on the physician marketing front, and we think this is smart direction for Insulet to head in. In 2015, the sales force expansion + medical marketing to physicians will add $15 million of incremental spending.
- Mr. Sullivan’s slide, “retooling for growth,” outlined other components of the near-term strategy: A newly announced commercial sales team (who previously worked with him at Cytyc) will help drive sales and marketing, particularly to managed care. Mr. Sullivan now has four Vice Presidents in the Commercial Team that will report to him directly: Sales; Marketing; Managed Care; and International. These businesses will have revenue broken out and reported publicly. Mr. Sullivan also plans to increase clinical studies and publications, develop an economic model for payers, secure Medicare reimbursement, focus on sales force execution, and develop/implement the product roadmap.
- By contrast, Mr. Sullivan seemed highly pleased with the company’s engineering and manufacturing capabilities, noting the “exquisite product design,” reliable high volume manufacturing (12 million pods per year), and high product quality.
- Insulet currently has ~75,000 worldwide customers and ~15% of the US insulin pump market. The former was a 25% rise from ~60,000 patients in January 2014. Mr. Sullivan believes there is significant future growth potential, as the company holds less than 4% of the overall US type 1 market (assuming ~27% of type 1s are on pumps). Consistent with previous metrics, 70% of Insulet’s patients are new to pumping, 35% of prescribers are new since the launch of the second-gen pod, ~30% of the customer base is <18 years, and approximately 60% of the customer base is <40 years. Insulet has seen “strong growth” in children <10 years since launch of the second-gen pod; Mr. Sullivan was particularly excited about the OmniPod’s potential in pediatrics.
- “We have very little data to demonstrate the product performs.” We assume this will change over time, as noted.Mr. Sullivan recounted the story of joining Insulet and asking for clinical data, where only one study was presented to him – a 59-patient trial from 2009 (Kane et al., Infusystems) demonstrating an A1c reduction of 0.49%. Said Mr. Sullivan in Q&A, “I’m never going to show that slide to you again. From my perspective, that doesn’t cut it.” Along with the help of the receptionist, Mr. Sullivan personally mined Insulet’s in-house data to better understand the clinical utility of the product. In a population of 1,350 new OmniPod users, he found that A1c declined by 1.1% after getting on the pod, with an average reduction in insulin use of 15 units per day. He made two things clear in his remarks: (i) clear frustration and outrage with the go-to market strategy and the paltry data used to defend the product’s value; and (ii) a staunch desire to invest much more time and resources in proving the clinical value of the OmniPod. Again, given the way healthcare is going, this is absolutely a prudent play, and certainly aligns with Dexcom’s recent remarks on this front.
- The OmniPod is currently available in 11 countries, and there is potential to expand to 22 countries. Current countries include US; Canada (GSK); Austria, Netherlands, Switzerland, UK, Norway, Sweden, Italy, and Germany (Ypsomed); and Israel (Geffen). The 2015 portion of the slide listed France and Finland as potential Ypsomed launches. (In France specifically, Insulet is still waiting for government approval.) Potential future launches with partner Ypsomed could include China, Saudi Arabia, Australia, Poland, Spain, UAE, and Qatar.
- Encouragingly, Mr. Sullivan plans to give specific sales figures for the US, international, Neighborhood Diabetes, and drug delivery businesses, a level of granularity that should help better manage expectations. Under previous CEO Mr. Duane DeSisto and CFO Brian Roberts, this level of specificity was never given.
- Mr. Sullivan outlined four pipeline project areas that will leverage the company’s current technology: the type 2 diabetes project with Lilly (~1.7 million patients), the new PDM, CGM integration & AP, and other drug delivery. He did not given any timing on any of the programs, and spent the most time discussing other drug delivery (“one of areas “ am most excited about” and a “tremendous growth opportunity”), the new PDM (touchscreen/modern looking, Bluetooth), and the CGM partnership with Dexcom (integrating the PDM with the Gen 5 mobile system). Though the slide noted the CGM-integrated OmniPod and “AP”, Mr. Sullivan did not address either, which was slightly disappointing. The presentation also did not discuss the LifeScan Verio-integrated PDM, which secured approval in November. Regarding pipeline product timing, the last updates came in the 3Q14 call: U500 OmniPod with Lilly (mid-2015 clinical study); Next-gen PDM (on display at ADA 2015, FDA filing in early 2016); OmniPod with integrated CGM fFirst in-human trial in early/mid-2015); Dexcom integration (following Gen 5 approval and next-gen PDM clearance).
- Mr. Sullivan expressed very significant excitement for Insulet’s opportunities in non-insulin drug delivery. He asserted that the OmniPOd is the only intelligent delivery system that can offer time dependent dosing, occlusion, alarm sensing, and communication. “The way in which drug delivery will be focused in the future.” Mr. Sullivan cited that 84% of patients use auto-injectors improperly, and there is a 30% discontinuation rate for the arthritis drug etanercept. Future opportunities include diabetes, infertility, oncology, pulmonary arterial hypertension, PTH, and more.
- Mr. Sullivan showed a picture of the Amgen Neulasta on-body delivery system, which has been in the works for five years. Basically, patients receive an injection of Neulasta in the clinic, at which time an OmniPod is put on with additional medication in it. Twenty-four hours after leaving the office, the OmniPod activates and delivers the drug. The product was designed with Amgen specifically for use with Neulasta; it will be packaged in the Neulasta delivery kit.
- Insulet estimates that there are ~1.7 million Americans with type 1 diabetes, with 15,000+ children and 15,000 adults diagnosed annually in the US (80 people per day). Mr. Sullivan cited JDRF’s estimate that 85% of type 1s are adults and 15% are children. The slide noted that type 1 diabetes is on the rise among the young – there was a 23% increase in the prevalence of type 1 in Americans under age 20 between 2001 and 2009. Type 1 diabetes reportedly accounts for $14.9 billion in annual healthcare costs in the US – there was no citation aside from JDRF.org on the slide.
- Insulet expects the pump market to reach ~50% penetration by 2019 in >1.7 million type 1s in the US. The slide noted 27% penetration as of 2012 on a base of 1.5 million patients. Citations were numerous: William Blair, Analyst Reports, IMS, WHO. This strikes us as a pretty aggressive projection for four years from now, though perhaps it is possible given the flurry of products and influx of companies.
-- by Melissa An, Adam Brown, Varun Iyengar, Emily Regier, Manu Venkat, and Kelly Close