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Edited Transcript of GERN income convention name or presentation 7-Nov-19 1:00pm GMT

MENLO PARK Nov 17, 2019 (Thomson StreetEvents) — Edited Transcript of Geron Corp income convention name or presentation Thursday, November 7, 2019 at 1:00:00pm GMT

* John A. Scarlett

Women and gents, thanks for status via, and welcome to the 3rd Quarter 2019 Geron Income Convention Name. (Operator Directions)

I’d now like handy the convention over for your speaker these days, Suzanne Messere. Please pass forward.

Thanks, Lisa, and excellent morning, everybody. Thanks for becoming a member of us for our 3rd quarter convention name. I’m joined these days via Dr. John Scarlett, Geron’s Chairman and Leader Govt Officer; Olivia Bloom, the corporate’s CFO; and Dr. Aleksandra Rizo, our Leader Clinical Officer.

After the marketplace closed the previous day, we introduced our 3rd quarter 2019 monetary effects by means of press liberate. It’s to be had on our web site beneath www.geron.com/traders. This morning, control will speak about the ideas from the previous day’s press liberate. A reside webcast of the decision is to be had on our web site and might be archived for 30 days.

Sooner than we start, please be aware that, apart from for statements of historic truth, this presentation and question-and-answer consultation include forward-looking statements made pursuant to the protected harbor provisions of the Non-public Securities Litigation Reform Act of 1995. Traders are cautioned that such forward-looking statements come with any of the corporate’s plans, expectancies, time traces, ideals, statements of potentiality and projections and with out limitation the ones relating to to — the ones relating to that the highest line effects from the Segment III portion of IMerge are anticipated to be to be had via midyear 2022, that there might be an end-of-Segment II assembly with the FDA via the tip of first quarter 2020, that Geron might probably broaden imetelstat for relapsed/refractory MF sufferers and that Geron’s 2019 working bills might be $80 million to $85 million. All of those forward-looking statements contain dangers and uncertainties that may purpose precise effects to vary materially from the ones in such forward-looking statements. Those dangers and uncertainties come with with out obstacles the ones relating to that the corporate is also not able to conquer all of the scientific protection, efficacy, technical, clinical, operational, production and regulatory demanding situations to allow the highest line effects from the Segment III portion of IMerge to be to be had via midyear 2022, that regulatory government would possibly not allow the additional construction of imetelstat on a well timed foundation or in any respect, that the corporate might come to a decision to not broaden imetelstat for relapsed/refractory MF sufferers and that there is also sudden working bills or occasions that purpose the $80 million to $85 million 2019 monetary steerage to be revised.

Detailed knowledge at the above dangers and uncertainties and extra dangers, uncertainties and components that might purpose precise effects to vary materially from the ones within the forward-looking statements are beneath the heading Chance components in Geron’s quarterly file on Shape 10-Q for the quarter ended September 30, 2019, filed with the SEC. Undue reliance must no longer be put on forward-looking statements, which discuss handiest as of the date they’re made, and the information and assumptions underlying the forward-looking statements might alternate. Aside from as required via legislation, Geron disclaims any legal responsibility to replace those forward-looking statements to replicate long run knowledge, occasions or instances.

With that, I might like to show the decision over to Dr. John Scarlett, Geron’s Chairman and CEO. Chip?

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John A. Scarlett, Geron Company – CEO, President & Chairman of the Board [3]

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Thank you, Suzanne, and excellent morning, everybody.

Geron continues to execute on its key 2019 imetelstat construction plans with the success of a number of essential milestones this previous quarter. We assumed complete keep an eye on of all construction for imetelstat via finishing the transition of this system again to Geron from Janssen on the finish of the 3rd quarter. Which means along with the U.S., we are now accountable for each IMerge and IMbark in all international locations the place the rigors are being carried out.

In August, we opened the Segment III IMerge trial for screening and enrollment. And in October, we introduced the primary affected person were dosed.

Extra just lately, in September, we introduced that the FDA granted Speedy Monitor designation to imetelstat for the remedy of grownup sufferers with intermediate-2 or high-risk myelofibrosis whose illness has relapsed after or is refractory to JAK inhibitor remedy. This is similar affected person inhabitants that we studied in Geron’s IMbark Segment II scientific trial.

With out a advertised drug particularly licensed for relapsed/refractory MF, there is a important unmet clinical want for this indication. The FDA’s Speedy Monitor program is designed to facilitate the advance and expedite the evaluate of recent medication which might be supposed to regard critical stipulations and which might be supported via information that display the prospective to deal with an unmet clinical want. We view the Speedy Monitor designation definitely because it supplies alternatives for extra widespread interactions with the FDA, the power to post sections of a New Drug Software on a rolling foundation and the eligibility to request precedence evaluate of an NDA.

At the name these days, Olivia will evaluate our 3rd quarter monetary effects and expectancies round long run construction prices. Subsequent, Aleksandra will remark at the abstracts that had been printed the previous day morning for the approaching American Society of Hematology Annual Assembly that might be held in December and the present standing of the Segment III IMerge trial. After that, I’m going to sum up the decision with you.

So I might like to show the decision over to Olivia, our CFO, who will evaluate monetary effects for the 3rd quarter. Olivia?

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Olivia Kyusuk Bloom, Geron Company – Govt VP of Finance, CFO & Treasurer [4]

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Thanks, Chip, and excellent morning, everybody. For the 3rd quarter of 2019, we reported a web lack of $15.2 million, or $0.08 in keeping with proportion, in comparison to $5.6 million or $0.03 in keeping with proportion for the 3rd quarter in 2018.

Web loss for the primary nine months of 2019 was once $39.Five million, or $0.21 in keeping with proportion, in comparison to $19.7 million, or $0.11 in keeping with proportion, for the primary nine months of 2018. Revenues for the three and nine months ended September 30, 2019, had been $131,000 and $289,000, respectively, in comparison to $165,000 and $691,000 for a similar sessions in 2018. Revenues for the three and nine months ended September 30, 2019 and 2018 incorporated royalty and license rate revenues beneath more than a few non-imetelstat license agreements. The decline in income displays a discount within the selection of energetic analysis license agreements in 2019 associated with the corporate’s telomerase opposite transcriptase, or hTERT, era on account of patent expiration at the underlying era.

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General working bills for the three and nine months ended September 30, 2019 had been $16.1 million and $42.Eight million, respectively, in comparison to $7 million and $22.2 million for the related 2018 duration.

Analysis and construction bills for the three and nine months ended September 30, 2019 had been $11.1 million and $27.1 million, respectively, in comparison to $2.7 million and $8.Four million for a similar sessions in 2018. The rise in analysis and construction bills in comparison to the similar sessions in 2018 essentially displays prices for the transition of the imetelstat program, together with resuming sponsorship on the ongoing imetelstat scientific trials, bills for start-up actions for the Segment III IMerge trial and better personnel-related prices for the increasing construction crew.

Basic and administrative bills for the three and nine months ended September 30, 2019 had been $Five million and $15.6 million, respectively, in comparison to $4.Three million and $13.Eight million for a similar sessions in 2018. The rise on the whole and administrative bills in comparison to the similar sessions in 2018 essentially displays upper company and patent felony prices and higher personnel-related bills for added head depend to beef up the advance group.

Hobby and different source of revenue for the three and nine months ended September 30, 2019 had been $1 million and $3.Three million, respectively, in comparison to $1.1 million and $2.2 million for the related 2018 sessions. The total build up in pastime and different source of revenue in 2019 in comparison to the similar sessions in 2018 essentially displays upper yields on our higher marketable securities portfolio.

We ended the 3rd quarter of 2019 with $159.Three million in money and marketable securities. Since Would possibly 2019, we now have raised cumulative web money proceeds of roughly $19.Three million from the gross sales of an mixture of 13,214,867 stocks of not unusual inventory beneath an at-market issuance gross sales settlement after deducting gross sales commissions and different providing bills payable via us. We think those web money proceeds to offer further monetary flexibility as we advance the imetelstat construction program. The budget will beef up long run construction prices, together with the IMerge Segment III trial.

As Chip discussed, we finished the transition of the imetelstat program from Janssen on the finish of the 3rd quarter of 2019. Final quarter, in June, we signed a scientific provide settlement with Janssen to buy sure inventories of drug product, drug substance and uncooked fabrics for imetelstat production. Below the availability settlement, we will be able to pay Janssen roughly $7.Five million for drug product upon cargo of the product to our specified drug garage and distribution facilities. We’ve additionally agreed to pay as much as roughly $6.7 million for drug substance and uncooked fabrics upon trying out and affirmation such fabrics meet sure specs. We aren’t obligated to buy fabrics that do not need trying out and comply with our high quality specs. We think supply of fabrics beneath the availability settlement and any trying out to be finished via the tip of December 2019, upon which we will be able to acknowledge the related bills in line with the accrual approach of accounting. We think money bills to Janssen for the fabrics to happen within the first quarter of 2020.

As such, we’re reaffirming our 2019 steerage and proceed to be expecting general working bills to vary from $80 million to $85 million, of which roughly $20 million to $25 million represents onetime prices that comes with imetelstat program transition process from Janssen to Geron and purchases of fabrics to offer the IMErge Segment III trial and get ready for brand new drug production.

As you realize, we started the 12 months with roughly $183 million in money and marketable securities. We estimate our year-end money and marketable securities to be roughly $145 million to $150 million. This projection comprises our 2019 working expense steerage, including again sure liabilities that might be paid in 2020, such because the purchases of Janssen fabrics, pastime source of revenue to be earned in 2019 and the $19.Three million in web money proceeds raised beneath the ATM program.

As of October 31, Geron has 42 workers and plans to develop to a complete of roughly 45 to 50 workers via year-end 2019, of whom part might be analysis and construction group of workers.

With that, I can flip the dialogue to Aleksandra.

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Aleksandra Rizo, Geron Company – Govt VP & Leader Clinical Officer [5]

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Thank you, Olivia. I can remark at the 2 abstracts authorized as poster shows on the ASH Annual Assembly to be held in December. The abstracts may also be discovered at the ASH web site at www.hematology.org.

Let me birth with the abstracts reporting information from nonclinical laboratory experiments at the doable results of mixing imetelstat and ruxolitinib on malignant myelofibrosis or MF cells. Ruxolitinib is the primary drug licensed for the remedy of myelofibrosis and till just lately was once the one drug. The two units of nonclinical experiments described on this summary discover the speculation that the combo of imetelstat and ruxolitinib would possibly create a remedy routine structure that may be extra efficacious than the use of both drug by myself.

Within the first set of experiments, spleen cells from MF sufferers and wire blood cells from wholesome folks, each and every containing hematopoietic stem and progenitor cells, had been grown in a tissue tradition lab and had been handled with 1 of four regimens: imetelstat by myself, ruxolitinib by myself, a mixture of ruxolitinib and imetelstat given concurrently and a mixture of ruxolitinib and imetelstat given sequentially.

In the second one set of experiments, mice had been transplanted with both MF spleen cells or commonplace wire blood cells after which handled with 1 of the Four regimens as used within the first set of experiments.

In each set of experiments, the sequential remedy of ruxolitinib adopted via imetelstat ended in important discounts within the numbers and the purposes of the malignant hematopoietic stem and progenitor cells originating from the MF spleen in comparison to both remedy by myself or the simultaneous remedy routine. Moreover, in each set of experiments, the sequential remedy routine didn’t impact the hematopoietic stem and progenitor cells originating from the standard wire blood cells.

The consequences from those experiments supply a possible further software of imetelstat in treating MF. Since the complexities concerned with combining 2 remedies with overlapping toxicities have no longer been explored, additional analysis could be had to decide the precise dose and agenda of the combo remedy sooner than lets come to a decision to pursue this as a possible remedy routine for MF. Within the intervening time, since imetelstat has proven single-agent process in more than a few hematologic malignancies, we intend to prioritize our efforts on advancing imetelstat as a person remedy routine.

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The second one summary authorized for ASH was once in a brand new class referred to as trials in development. Abstracts for this class describe leading edge scientific trials that experience no longer reached their number one endpoint to offer alternatives for early engagement and collaboration among translational, scientific and business investigators, statisticians and regulators. As well as, abstracts on this class strengthen the visibility of ongoing scientific trials to pursue a affected person recruitment.

We’re happy that the Segment III IMerge trial has been incorporated on this new class, and main points of the trial design might be offered in a poster. Many facets of the Segment III trial design, together with the principle and secondary endpoints, the objective affected person inhabitants and the dose and agenda of imetelstat management, stay in keeping with the Segment II portion of the trial.

Along with the shows of the two abstracts, we additionally look ahead to the approaching ASH Annual Assembly and we’re sponsoring Three further tutorial symposia. And we will give you the option to hook up with the investigators (inaudible) might be actively focused on affected person recruitment and enrollment.

In regards to the segment III IMerge trial start-up actions, we now have just lately hosted 2 conferences, one in U.S. and one in Europe, for investigators and taking part website group of workers. The reception at those conferences has been very high-quality. The primary affected person was once dosed in October, and roughly 30% of the website are open for enrollment. At this level of the trial, it’s too early to decide what the enrollment dynamics might be since lower than 50% of the websites are open and most of the websites which might be anticipated to be excessive enrollers, in particular in Europe, haven’t begun to be opened. We think to have a greater sense of enrollment dynamics via the tip of the primary quarter of 2020.

Going ahead, we plan to offer qualitative updates on enrollment right through our quarterly convention calls. We will be able to be expecting to announce when part of the sufferers were concerned within the trial and when the trial is absolutely enrolled. Based totally upon our present making plans assumptions, we proceed to be expecting best line effects via midyear 2022.

And now I can flip the dialogue again to Chip.

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John A. Scarlett, Geron Company – CEO, President & Chairman of the Board [6]

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Thank you, Aleksandra. Shifting directly to MF. As mentioned in the past, we are lately within the technique of making ready to behavior an end-of-Segment II assembly with the FDA via the tip of the primary quarter of 2020 and can due to this fact announce our choice relating to any doable long run late-stage construction plans for relapsed/refractory MF. This choice might be influenced via, amongst different issues, the character of our discussions with the FDA, via our review of what could be required to reach scientific and regulatory luck on this indication, together with the price and period of any doable scientific trials required for regulatory approvals in america and Eu Union.

So in abstract, we are a far other corporate these days than we had been a 12 months in the past. We proceed to make nice development in 2019, from development a forged basis of in-house experience in hematology/oncology and in late-stage construction to dosing the primary affected person within the Segment III IMerge scientific trial. We are taken with opening websites to allow affected person recruitment and enrollment for the Segment III and on making ready for the end-of-Segment II assembly with the FDA on — in relapsed/refractory MF. All the construction actions finished up to now and deliberate for the long run beef up the advance of imetelstat as a possible remedy to deal with unmet clinical wishes in hemalogic (sic) [hematologic] myeloid malignancies. We look ahead to the rest of this pivotal 12 months. As we proceed to execute on our 2019 construction plans, we imagine our accomplishments will translate into shareholder price over the longer term.

So with that, we are now satisfied to respond to your questions, and we will flip the decision again to the operator.

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Questions and Solutions

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Operator [1]

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(Operator Directions) And our first query comes from the road of Charles Duncan from Cantor Fitzgerald.

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Pete George Stavropoulos, Cantor Fitzgerald & Co., Analysis Department – Affiliate Analyst [2]

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That is Pete Stavropoulos on for Charles. One query relating to — so that you — we now have a possible approval of luspatercept. And I used to be questioning whether or not you suppose you could have problem enrolling RS-positive sufferers into the find out about, for the reason that the physicians might steer them in opposition to an licensed drug. If that is so, how do you suppose that can impact the total find out about time line? And would you believe enrolling sufferers that relapse or refractory to luspatercept into the IMerge find out about?

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Aleksandra Rizo, Geron Company – Govt VP & Leader Clinical Officer [3]

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I am satisfied to — it is Aleksandra right here, I’m going to take that query. So I imply as we simply discussed, proper, we’re open for screening and enrollment. And we think to be beautiful some distance alongside within the enrollment procedure by the point of the PDUFA date for luspatercept. And that can fall in all probability with the approval in Europe right through the second one part of the 2020. So we’d be expecting to be with reference to finishing enrollment via that point. And simply primarily based upon what we all know these days, we imagine that it’s not likely that the prospective approval of luspatercept will affect our enrollment time line.

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Pete George Stavropoulos, Cantor Fitzgerald & Co., Analysis Department – Affiliate Analyst [4]

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Ok. And for the abstracts for ASH, you’ll provide nonclinical information for the routine of sequential remedy of a JAK inhibitor with imetelstat. So is there an opportunity of including an MF — an arm into the MF find out about for this remedy routine? And do you suppose it will be probably the most checklist of subjects with the FDA on the end-of-Segment II assembly?

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Aleksandra Rizo, Geron Company – Govt VP & Leader Clinical Officer [5]

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[I think –] as I discussed, proper, extra paintings would want to be executed to pursue a scientific find out about with the combo, in order that would come with cautious exploration of the overlapping toxicities between the two medication. In this day and age, our assets and bandwidth are taken with advancing imetelstat as a single-agent remedy such because the IMerge Segment III scientific trial, and likewise, we paintings arduous on figuring out the prospective regulatory trail for relapsed/refractory MF. So I — we imagine nowadays, it must keep our center of attention.

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Pete George Stavropoulos, Cantor Fitzgerald & Co., Analysis Department – Affiliate Analyst [6]

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Ok. And are you able to speculate as to why sequential dosing relatively than simultaneous dosing can have a better aid in MF hematopoietic cells and progenitor cells?

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Aleksandra Rizo, Geron Company – Govt VP & Leader Clinical Officer [7]

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Proper, proper. Sure, so we — sure, I will come up with some taste of that. And as it’s possible you’ll know, ruxolitinib has been reported to be a DNA-damaging agent and no longer an antiapoptotic agent. So with the experiments with the sequential remedy, what occurs is that you just first induce DNA harm into those MF malignant cells. And after that, you induce an antiapoptotic agent like imetelstat. Subsequently, the combo has an angle or impact or synergistic impact, if you’ll, at the malignant cells. That is the speculation.

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Operator [8]

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Our subsequent query comes from the road of Tom Shrader from BTIG.

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Kaveri Pohlman;BTIG, [9]

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That is Kaveri for Tom. I simply have one on IMerge. May just there be any incremental information from the Segment II trial between now and once we first be expecting information from the Segment III find out about?

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John A. Scarlett, Geron Company – CEO, President & Chairman of the Board [10]

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In different phrases, any more or less period in-between research or any more or less different information, is that the query? Or did I leave out that?

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Kaveri Pohlman;BTIG, [11]

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Sure.

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John A. Scarlett, Geron Company – CEO, President & Chairman of the Board [12]

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Oh, I am sorry.

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Olivia Kyusuk Bloom, Geron Company – Govt VP of Finance, CFO & Treasurer [13]

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I feel she’s asking whether or not we will have any follow-up information from the Segment II portion of IMerge sooner or later.

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John A. Scarlett, Geron Company – CEO, President & Chairman of the Board [14]

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Ok.

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Aleksandra Rizo, Geron Company – Govt VP & Leader Clinical Officer [15]

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In this day and age, we don’t plan to have that, a minimum of no longer on the subsequent ASH or EHA convention. We will be able to have a look at the knowledge because it evolves and can allow you to know if that is modified.

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Operator [16]

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And our subsequent query comes from the road of Gil Blum from Needham & Corporate.

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Gil Joseph Blum, Needham & Corporate, LLC, Analysis Department – Analyst [17]

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Only a fast one about modeling. I simply need to be certain that I understood. So we think a gorgeous important pickup on This fall R&D bills. Is that an effective way to take a look at this?

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Olivia Kyusuk Bloom, Geron Company – Govt VP of Finance, CFO & Treasurer [18]

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Sure, Gil. As in case you have observed throughout the 12 months, there was a gradual build up within the — pickup in each R&D and G&A expense, particularly R&D clearly for the start-up actions for the Segment III in addition to the hiring of people into the advance crew.

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Gil Joseph Blum, Needham & Corporate, LLC, Analysis Department – Analyst [19]

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All proper. And — however my query is extra of, am I anticipating an overly important build up, most commonly within the fourth quarter to be nearly like a one-off in that sense?

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Olivia Kyusuk Bloom, Geron Company – Govt VP of Finance, CFO & Treasurer [20]

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Sure. And that is the reason consequently, as I discussed concerning the purchases of the availability fabrics which might be coming from Janssen. However when you upload the two in combination, that is nearly $14 million. And since we think the supply and the trying out actions to be finished via the tip of the 12 months, I want to accrue them for accounting functions. And the ones bills might hit in 2019, even if the money would possibly not hit — the money outlay won’t hit till the next quarter.

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Gil Joseph Blum, Needham & Corporate, LLC, Analysis Department – Analyst [21]

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Were given you. That is helping.

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Olivia Kyusuk Bloom, Geron Company – Govt VP of Finance, CFO & Treasurer [22]

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Ok.

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Gil Joseph Blum, Needham & Corporate, LLC, Analysis Department – Analyst [23]

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And only one extra about ASH. It sort of feels like we are going to get a gorgeous thrilling ASH for myelofibrosis. We are getting some information from Constellation, I perceive, and there may be extra information popping out of fedratinib. However do you guys suppose possibly relapsed/refractory myelofibrosis is getting more or less highlighted on this upcoming ASH?

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Aleksandra Rizo, Geron Company – Govt VP & Leader Clinical Officer [24]

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I feel it is all the time a excellent information for sufferers to have new and — information for probably new medication to be had for them. I imply the Eastern information — you might be proper, proper? There are a couple of abstracts which might be each in frontline and relapsed/refractory MF. Fedratinib obviously continues to turn scientific receive advantages then again you analyze the knowledge. Once more, imetelstat has a special mechanism of motion than fedratinib, in order that’s the place we keep centered and differentiate.

In relation to the Constellation information this is being reported, as you discussed, once more, each information on frontline and relapsed/refractory MF, simply as an statement, proper, that the knowledge is intriguing and it is early and it continues to be observed how the knowledge will mature. So sure, I imply it is a excellent ASH for myelofibrosis, as you assert.

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Gil Joseph Blum, Needham & Corporate, LLC, Analysis Department – Analyst [25]

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Superb. Congratulations at the development on this quarter.

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Aleksandra Rizo, Geron Company – Govt VP & Leader Clinical Officer [26]

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Thanks.

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Olivia Kyusuk Bloom, Geron Company – Govt VP of Finance, CFO & Treasurer [27]

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Thanks.

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John A. Scarlett, Geron Company – CEO, President & Chairman of the Board [28]

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Thank you very a lot.

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Operator [29]

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(Operator Directions) And this ends the Q&A consultation. I can flip the decision over to Dr. John Scarlett for last remarks.

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John A. Scarlett, Geron Company – CEO, President & Chairman of the Board [30]

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Thank you, everyone, for becoming a member of us these days. Sit up for reporting endured development as we pass ahead right here. Have a excellent day.

Bye.

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Operator [31]

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Women and gents, this concludes these days’s convention name. Thanks for taking part.

You might now disconnect.


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