Amphastar Pharmaceuticals,Inc。(AMPH) 2019年 第二季度业绩 - 盈利电话会议记录

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Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) Q2 2019 Earnings Conference Call August 7, 2019 5:00 PM ET

Amphastar Pharmaceuticals,Inc。(纳斯达克股票代码:[AMPH])2019年第二季度收益电话会议2019年8月7日美国东部时间下午5:00

公司参与者

Jason Shandell - President
Bill Peters - Chief Financial Officer

  • 杰森桑德尔 - 总统
  • Bill Peters - 首席财务官

电话会议参与者

David Maris - Wells Fargo
Gary Nachman - BMO Capital Markets
David Steinberg - Jefferies
David Amsellem - Piper Jaffray
Serge Belanger - Needham

  • 大卫马里斯 - 富国银行
  • Gary Nachman - BMO资本市场
  • 大卫斯坦伯格 - 杰弗里斯
  • David Amsellem - Piper Jaffray
  • Serge Belanger - Needham

会议主持员

Good day, ladies and gentlemen, and welcome to the Amphastar Second Quarter Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we'll conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] As a reminder, this call may be recorded.
This conference call may contain forward-looking statements, including statements relating to Amphastar Pharmaceuticals. These statements are not historical facts but rather based on Amphastar Pharmaceuticals' current expectations, estimates and projections regarding Amphastar Pharmaceuticals' business, operations and other similar or related factors. Words such as may, might, will, could, would, should, anticipate, predict, potential, continue, expects, intends, plans, projects, believes, estimates, and other similar or related expressions are used to identify these forward-looking statements.
These statements are only predictions and are -- such are not guarantees of future performance and they involve risks, uncertainties and assumptions that are difficult or impossible to predict. Actual results may differ materially from those and the forward-looking statements as a result of a number of factors, including these described from time-to-time in Amphastar Pharmaceuticals' filings with the SEC.
I would now like to introduce your host for today's conference, Mr. Jason Shandell. You may begin.

女士们,先生们,美好的一天,欢迎参加Amphastar第二季度收益电话会议。此时,所有参与者都处于只听模式。之后,我们将进行问答环节,并在当时进行说明。 [操作员说明]提醒一下,可能会记录此呼叫。

本次电话会议可能包含前瞻性陈述,包括与Amphastar Pharmaceuticals有关的陈述。这些陈述不是历史事实,而是基于Amphastar Pharmaceuticals目前对Amphastar Pharmaceuticals的业务,运营和其他类似或相关因素的预期,估计和预测。诸如可能,可能,将,可能,将,应该,预期,预测,潜在,继续,预期,打算,计划,项目,信念,估计和其他类似或相关表达的词语用于识别这些前瞻性陈述。

这些陈述仅是预测,并且 - 不是对未来业绩的保证,而是涉及难以或无法预测的风险,不确定性和假设。由于许多因素,实际结果可能与那些以及前瞻性陈述产生重大差异,包括Amphastar Pharmaceuticals向美国证券交易委员会提交的文件中不时描述的因素。

我现在想向大家介绍今天的会议,Jason Shandell先生。你可以开始吧。

Jason Shandell

Thank you, operator. Good afternoon and welcome to Amphastar Pharmaceuticals second quarter earnings call. My name is Jason Shandell, President of Amphastar. I'm joined today with my colleague, Bill Peters, CFO of Amphastar. We appreciate you joining us on the call today and look forward to speaking with you and answering any questions you may have.
The Company had a great second quarter with sales increasing 11% and gross profit increasing from 37% to 41% as compared to the second quarter in 2018. Additionally, on June 27, we received $59.9 million from Sandoz and Momenta to settle all outstanding litigation between the parties. This significantly strengthened our balance sheet with total net cash and short-term investments of $127.4 million as of June 30. We plan to use the settlement funds to continue to invest in research and development, including clinical trials for our inhalation and insulin pipeline and also to expand our capacity at Amphastar for future pipeline products.
Furthermore, our legal expenses will be dramatically reduced going forward, allowing our management team to focus on growing our core business and further advancing our robust pipeline of product candidates, including complex peptides, complex proteins and combination inhalation products.
Our pipeline continues to make good progress. We currently have four ANDAs on file, targeting products with the market size of over $800 million, three biosimilar products in development, targeting products with the market size of approximately $14 billion and 11 generic products in development, targeting products with the market size of approximately $14 billion.
With respect to our proprietary pipeline, we have one NDA on file and three other NDAs in development, targeting significant markets. It should be noted that four of our ANDAs on file with the agency were granted competitive generic therapy designations, which could help speed the time to approval. Two of the four ANDAs have been previously disclosed. One is vasopressin, which has a 30-month stay due to the Paragraph IV litigation and the second is epinephrine in a 30-ml vial. We have PDUFA dates in the second half of this year for our epinephrine ANDA and another undisclosed complex injectable product. We remain on track to file two to two ANDAs this year, which are all injectable products.
With respect to our first inhalation ANDA, we have had continued discussions with the agency, which have helped us enhance our robust development strategy. As a result of these interactions, we have increased the number of subjects in our ongoing clinical trial in order to provide more confidence in meeting our endpoints. Therefore, that filing is now planned for 2020. As you may be aware, there has been no previously approved HFA metered dose inhalers under an ANDA. However, we believe that our discussions with the agency will lead to a successful trial for our first inhalation ANDA.
We are also making good progress on our insulin programs and are having active communications with the agency regarding the IND that we filed in the first quarter. These information exchanges have been positive as we further focus our development program and establish a relationship with the BLA team at the agency. This is particularly important as the agency transitions from considering insulin as a drug to a biologic.

谢谢运营商。下午好,欢迎来到Amphastar Pharmaceuticals第二季度财报电话会议。我的名字是Amphastar总裁Jason Shandell。我今天和我的同事,Amphastar首席财务官Bill Peters一起参加了会议。感谢您今天加入我们的电话会议,期待与您交谈并回答您的任何问题。

公司第二季度表现良好,销售额增长11%,毛利率从2018年第二季度的37%增加到41%。此外,6月27日,我们从Sandoz和Momenta获得了5990万美元以解决所有未决诉讼各方之间。截至6月30日,这显着增强了我们的资产负债表,总净现金和短期投资为1.274亿美元。我们计划使用结算资金继续投资研发,包括吸入和胰岛素管道的临床试验以及扩大我们在Amphastar的未来管道产品的产能。

此外,我们的法律费用将在未来大幅减少,使我们的管理团队能够专注于发展我们的核心业务,并进一步推进我们强大的候选产品系列,包括复合肽,复合蛋白和复合吸入产品。

我们的管道继续取得良好进展。我们目前有4个ANDA,目标是市场规模超过8亿美元的产品,三个生物仿制药产品正在开发中,目标市场规模约为140亿美元,11个通用产品正在开发中,目标产品的市场规模约为140亿美元。

关于我们的专有管道,我们有一个NDA存档和三个其他NDAs正在开发中,针对重要市场。应该注意的是,我们向该机构提交的四份ANDA被授予竞争性通用治疗指定,这有助于加快批准时间。先前已经公开了四个ANDA中的两个。一种是加压素,由于第四段诉讼而停留30个月,第二种是30毫升小瓶中的肾上腺素。今年下半年我们的肾上腺素ANDA和另一种未公开的复合注射产品的PDUFA日期。我们仍然有望在今年提交两到两个ANDA,这些都是注射产品。

关于我们第一次吸入ANDA,我们继续与该机构进行讨论,这有助于我们加强我们强有力的发展战略。由于这些相互作用,我们增加了正在进行的临床试验中的受试者数量,以便更有信心地满足我们的终点。因此,该备案现在计划在2020年进行。您可能已经知道,在ANDA下没有先前批准的HFA计量吸入器。但是,我们相信,我们与该机构的讨论将导致我们第一次吸入ANDA的成功试验。

我们在胰岛素计划方面也取得了良好进展,并且正在与该机构就第一季度提交的IND进行积极沟通。这些信息交流是积极的,因为我们进一步关注我们的发展计划,并与该机构的BLA团队建立关系。随着该机构从考虑胰岛素作为药物转变为生物制剂,这一点尤为重要。

With respect to our intranasal naloxone NDA, we had previously received general advice letters from the agency and are continuing to improve the product based on the agency's advice. There continues to be strong interest by the agency in this product and we believe that our improved product will address all of their concerns. We anticipate resubmitting the NDA in 2020.
With respect to Primatene Mist, we continue to see a positive trend in the retail store level with a 50% increase in unit sales from the first quarter to the second quarter. In July, we began running national television and radio commercials and also launched the product on walmart.com. We believe that our online presence on walmart.com will provide a smooth transition for a successful launch into Walmart stores in the fourth quarter.
In addition to focusing on increasing consumer awareness and selling to the large retailers and pharmacies, we are also beginning to expand distribution of the product to more independent pharmacies and small retail chains. We remain very excited with the prospects for Primatene Mist and we continue to forecast return to peak sales of $65 million in the next two to three years.
Finally, we continue to believe in our disciplined management strategy and vertically integrated business model that has enabled us to rise above the risks posed by the current trade and political tensions while focusing on complex, hard to produce quality products. We strive to achieve long-term sales and profit growth from [indiscernible] pipeline, which should help insulate us from legal and compliance risk stemming from the pursuit of short-term gains.
With that, I will turn the call over to Bill Peters, our CFO, to go through the second quarter financial results.

关于我们的鼻内纳洛酮NDA,我们之前收到了该机构的一般建议书,并根据该机构的建议继续改进产品。该机构对该产品的兴趣仍然很强烈,我们相信我们改进的产品将解决他们所有的顾虑。我们预计2020年将重新提交保密协议。

就Primatene Mist而言,我们继续看到零售店层面的积极趋势,第一季度至第二季度的单位销售额增长了50%。 7月,我们开始运营国家电视和广播广告,并在walmart.com上推出该产品。我们相信,我们在walmart.com上的在线业务将为第四季度成功进入沃尔玛商店提供平稳过渡。

除了专注于提高消费者意识和向大型零售商和药店销售外,我们还开始将产品的分销范围扩大到更多的独立药房和小型零售连锁店。我们对Primatene Mist的前景感到非常兴奋,我们将继续预测未来两到三年内销售额将达到6500万美元。

最后,我们继续相信我们严谨的管理战略和垂直整合的业务模式,使我们能够超越当前贸易和政治紧张局势所带来的风险,同时专注于复杂,难以生产的优质产品。我们努力通过[音频不清晰]管道实现长期销售和利润增长,这有助于我们避免因追求短期收益而产生的法律和合规风险。

有了这个,我将把这个电话转交给我们的首席财务官比尔·彼得斯,以完成第二季度的财务业绩。

比尔彼得斯

Thank you, Jason. Sales for the second quarter increased 11% to $79 million from $71 million in the previous year's period. Phytonadione was our biggest selling product in the quarter, with sales of $12.4 million, up from $10.8 million, primarily due to higher average selling prices. Lidocaine had a small sales increase to $10.1 million from $10 million. Enoxaparin saw sales increase to $9.8 million from $8.7 million in the year prior, as higher average selling prices more than offset unit declines. Naloxone sales declined to $7.8 million from $11.1 million on lower unit volumes at lower average selling prices.
Medroxyprogesterone sales increased to $6.7 million from $6.4 million. Sales from Primatene Mist totaled $2.5 million as we began loading the product into wholesalers as part of our marketing plan to target independent drug stores and smaller chains. Higher sales of Cortrosyn, dextrose, calcium chloride, sodium bicarbonate and other products due to market shortages and higher sales of isoproterenol, which was launched in the third quarter of 2018, also contributed to increased sales for our other finished pharmaceutical products.
Our insulin API business had sales of $5.3 million, down from $7.8 million in the prior year, primarily due to the timing of shipments. Gross margins increased to 41% of sales from 37% of sales as we had increased sales of high margin products like medroxyprogesterone, Primatene Mist, Cortrosyn, and isoproterenol.
Selling, distribution and marketing expenses increased to $3 million from $1.9 million, primarily due to marketing costs associated with the launch of Primatene Mist. These expenditures were for our digital marketing campaign and the development of our television ads, which begin airing in July. General and administrative spending increased slightly to $12.4 million from $11.7 million, primarily because of higher legal expenses related to the antitrust case against Momenta and Sandoz.
However, this amount was significantly lower than the first quarter spending of $16.4 million as we settled the case in the quarter and were able to decrease spending. Research and development expenditures increased to $16 million from $15.5 million for two reasons. One, the expansion of our R&D team at our China subsidiary, Amphastar Nanjing Pharmaceuticals due to the expansion of both pipeline projects and establish finished products for the Chinese market. Two, to increase clinical trial expenses for our first planned inhalation ANDA. These increases were partially offset by lower expenses related to pre-launch inventory.
We usually don't mention other income on our earnings call, because it is usually not material. However, this quarter, we settled our long-standing case with Momenta and Sandoz and received a $59.9 million settlement, which was booked to other income. I want to note that while this -- while the book taxes for this payment will be at our normal rate for US federal and state taxes of about 25% or an amount close to $15 million. We are planning to use a significant portion of our deferred tax assets, including a small amount of net operating loss carryforwards and larger amount of research and development tax credits, both at the federal level and for the State of California. This will bring the actual cash tax paid for the settlement to an amount closer to $2 million. So, we will net about $58 million in cash from the settlement.

谢谢你,杰森。第二季度的销售额从去年同期的7100万美元增长了11%,达到7900万美元。 Phytonadione是本季度最畅销的产品,销售额为1,040万美元,高于1,080万美元,主要原因是平均销售价格上涨。利多卡因的销售额从1000万美元增加到1010万美元。依诺肝素的销售额从去年同期的870万美元增加到980万美元,因为平均销售价格高于抵消单位的下降。由于平均销售价格较低,纳洛酮的销售额从1110万美元下降至780万美元。

Medroxyprogesterone的销售额从640万美元增加到670万美元。当我们开始将产品装入批发商时,Primatene Mist的销售总额为250万美元,作为我们针对独立药店和小型连锁店的营销计划的一部分。由于市场短缺以及2018年第三季度推出的异丙肾上腺素销售额增加,Cortrosyn,葡萄糖,氯化钙,碳酸氢钠和其他产品的销售额增加,也促进了我们其他成品药品的销售增长。

我们的胰岛素原料药业务销售额为530万美元,低于去年同期的780万美元,主要原因是出货时间。毛利率从销售额的37%增加到销售额的41%,因为我们增加了高利润产品的销售额,如甲羟孕酮,灵长类喷雾剂,Cortrosyn和异丙肾上腺素。

销售,分销和营销费用从190万美元增加到300万美元,这主要是由于与Primatene Mist推出相关的营销成本。这些支出用于我​​们的数字营销活动和电视广告的开发,这些广告将于7月开播。一般和行政支出从1170万美元略微增加至1240万美元,主要是因为与针对Momenta和Sandoz的反托拉斯案相关的法律费用增加。

然而,由于我们在本季度结算并且能够减少支出,这一数额显着低于第一季度的1640万美元支出。由于两个原因,研发支出从1550万美元增加到1600万美元。一,由于两个管道项目的扩展和为中国市场建立成品,我们在中国子公司Amphastar南京制药的研发团队的扩张。二,增加我们第一次计划吸入ANDA的临床试验费用。这些增长部分被与发射前库存相关的较低费用所抵消。

我们通常不会在我们的财报电话中提及其他收入,因为它通常不重要。然而,本季度,我们与Momenta和Sandoz解决了长期存在的案件,并获得了5990万美元的和解,这笔款项被记入其他收入。我想要指出的是,虽然这一点 - 这笔付款的账面税将按照美国联邦税和州税的正常税率约为25%或接近1500万美元。我们计划在联邦和加利福尼亚州使用我们的递延税项资产的很大一部分,包括少量的净经营亏损结转和更大量的研发税收抵免。这将使结算所支付的实际现金税额接近200万美元。因此,我们将从和解中获得约5800万美元现金。

The Company reported net income attributable to Amphastar shareholders of $47.8 million or $0.96 per share in the second quarter, compared to a loss of $2.9 million or $0.06 per share in the second quarter of 2019. The Company reported an adjusted net income of $4.1 million or $0.08 per share, compared to an adjusted net income of $1.2 million or $0.02 per share in the second quarter of last year. Adjusted earnings exclude amortization, equity compensation, impairments of long-lived assets and legal settlements.
In the second quarter, cash flow provided by operations was approximately $51.7 million. Total equity increased to $364 million at the end -- from $364 million at the end of 2018 to $432 million at the end of June 30, 2019, an increase of 18.6%. And during the quarter, we repurchased $1.1 million of stock, which completed the buyback program authorized in 2018. As we mentioned on the last call, the Board authorized an additional $20 million buyback program, which we plan to utilize in the future.
I will now turn the call back over to the operator to begin Q&A.

公司报告第二季度Amphastar股东应占净收入为4780万美元或每股0.96美元,而2019年第二季度为亏损290万美元或每股0.06美元。公司报告调整后净收入为410万美元或每股0.08美元,而去年第二季度的调整后净收入为120万美元或每股0.02美元。调整后的收益不包括摊销,股权补偿,长期资产减值和法律和解。

在第二季度,运营提供的现金流约为5170万美元。最终总股本增加至3.64亿美元 - 从2018年底的3.64亿美元增加到2019年6月30日的4.32亿美元,增长18.6%。在本季度,我们回购了110万美元的股票,完成了2018年授权的回购计划。正如我们在上次电话会议中提到的那样,董事会批准了另外2000万美元的回购计划,我们计划在未来使用该计划。

我现在将回拨给操作员以开始问答。

问答环节

[Operator Instructions] Our first question comes from David Maris with Wells Fargo. Your line is now open.

[操作员说明]我们的第一个问题来自David Maris和Wells Fargo。 你的生产线现已开放。

大卫马里斯

Good afternoon. First, I noticed that you filed the DMF for teriparatide during the quarter. So, a few questions. When would you expect to file FORTEO? Secondly, will this be a product for the US and international markets since FORTEO sells a lot outside the US or is it just intended for the US? And then I have another question.

下午好。 首先,我注意到你在本季度提交了用于teriparatide的DMF。 那么,几个问题。 您何时可以申请FORTEO? 其次,这是否是美国和国际市场的产品,因为FORTEO在美国境外销售很多,或者它只是针对美国? 然后我有另一个问题。

Jason Shandell

Sure. Yes. Definitely always good to look at our DMF filings. Our Chinese subsidiary has been very active, currently have 12 Drug Master Files and we're developing six additional. And with respect to your question, we do ultimately intend to sell both US and internationally.

当然。 是。 绝对总能看到我们的DMF文件。 我们的中国子公司非常活跃,目前有12个药物主文件,我们正在开发另外六个。 关于你的问题,我们最终打算出售美国和国际。

大卫马里斯

And then just as a follow-up, what's the usual timeline from filing a DMF to filing a product? Is there a good rule of thumb?

然后,作为后续行动,从提交DMF到提交产品的通常时间表是什么? 有一个很好的经验法则吗?

Jason Shandell

I don't think there is a good rule of thumb. It really depends on the complexity of the product and discussions with the agency. We definitely focus on the more difficult to produce. So, I wouldn't say there is a rule of thumb. It's going to be several years until we launch.

我认为没有一个好的经验法则。 这实际上取决于产品的复杂性和与代理商的讨论。 我们绝对专注于更难生产。 所以,我不会说有一个经验法则。 我们推出将需要几年时间。

大卫马里斯

And then Bill, you mentioned the other finished pharmaceutical products that did very well, but you ran through kind of the components of what that benefit was at least too quickly for my typing. Can you just describe those again and whether or not those are -- if you had to characterize them, are those more one-time in nature or is that something like shortages that should continue for a while? Or is it a large enough number of products where maybe some do and some don't but this level of sales should be expected going forward since it was a big step-up sequentially?

然后比尔,你提到其他成品药品做得非常好,但你经历了那种好处的组成部分至少对我的打字来说太快了。 您能再次描述一下这些是否 - 如果您必须对它们进行描述,是那些更具有一次性质的还是那些应该持续一段时间的短缺? 或者它是一个足够多的产品,可能有些人做了,有些做不到,但这个销售水平应该是预期的,因为它是一个大的升序顺序?

比尔彼得斯

So, specifically, I mentioned the four products that had the highest sales increases due to shortages and those were Cortrosyn, dextrose, calcium chloride and sodium bicarbonate, but there was also a few other products that also had some shortages, including one of the SKUs of lidocaine and I'm trying to [Indecipherable] right now. Some of those products are still experiencing market shortages. However, we are shipping out as much as we can due to the capacity constraints that we have where most of those products because they're sold out of our IMS facility in South El Monte. The Cortrosyn sold out. At the Amphastar, we do have some capacity here. So, we are fully able to satisfy that. But on things like the sodium bicarbonate, we can't really even meet up -- keep up with the demand of that product still.
But these products have had a history of having a shortage for a few quarters and then coming back and then a different mix of products. It just happened that this quarter was a little bit different in that Cortrosyn, which is at a higher price level and the higher margin level, is also experiencing shortages while the critical care products are -- were also experiencing shortages.
And just another word on that is that as we've been telling people we've built extra capacity at that factory recently and we're still in the process of validating that. We hope to have that factory online by the end of the year.

因此,具体而言,我提到由于短缺导致销量增长最快的四种产品,包括Cortrosyn,葡萄糖,氯化钙和碳酸氢钠,但也有一些其他产品也有一些短缺,包括其中一个SKU利多卡因和我现在正试图[难以理解]。其中一些产品仍然存在市场短缺。但是,由于我们在大多数产品中的产能限制因为它们已经从我们位于南埃尔蒙特的IMS设施中销售,我们正在尽可能多地出货。 Cortrosyn卖光了。在Amphastar,我们确实有一些容量。所以,我们完全能够满足这一要求。但是在碳酸氢钠等方面,我们甚至无法满足 - 仍然能够满足该产品的需求。

但是这些产品有过几个季度短缺的历史,然后又回来了,然后是不同的产品组合。事实恰恰相反,本季度有点不同,因为价格较高且利润率较高的Cortrosyn也出现短缺,而重症护理产品也出现短缺。

而另一个消息是,正如我们一直在告诉人们我们最近在该工厂建立了额外的容量,我们仍然在验证这一点。我们希望在今年年底之前在网上建立这家工厂。

大卫马里斯

Great. Thank you very much.

非常好。 非常感谢你。

会议主持员

[Operator Instructions] Our next question comes from Gary Nachman with BMO Capital Markets. Your line is now open.

[操作员说明]我们的下一个问题来自BMO Capital Markets的Gary Nachman。 你的生产线现已开放。

加里·纳赫曼

Hi. Primatene sales stalled a bit in 2Q relative to 1Q and 4Q. So, how much was additional stocking in the quarter versus reorders that are coming through? And are you still expecting to get into Walmart? When will that be? Did you say that would be in the four quarter? And then what sort of impact do you expect that TV and radio ads will have? You just started them in July. I know it's early, but just give us a sense of the magnitude and when we could see an impact from that. And then I have a follow-up after.

你好。 相对于第一季度和第四季度,Primatene销售额在第二季度停滞不前。 那么,本季度增加的库存量与正在进行的重新订购量相比多少? 你还想进入沃尔玛吗? 那会是什么时候? 你说那会是四季吗? 那么你期望电视和广播广告会产生什么样的影响呢? 你刚刚在七月开始了。 我知道这是早期的,但只是让我们了解它的重要性,以及何时可以看到它的影响。 然后我跟进了。

Jason Shandell

Sure. So, let me begin, this is Jason. So, I'll start with the Walmart question and the advertising question, then I'll turn over the stocking question to Bill. So with respect to Walmart, yes, we're set to launch in the fourth quarter. So yes, we're very excited about that. They intend to place the product in all Walmart stores and we think that's going to be a really good increase in sales for the Company. I've said in the previous call that historically the CFC version of Primatene, Walmart made up 35% of sales.
So we're excited, they seem excited by the product and there should be some good promotion both in-store and we may even ramp up some of our ads, because we are -- it is early to your point, but we're seeing very good indication that the ads are working. We saw very big surge in sales with that. So we get lagging data from the major retailers and one of the major retailers, we saw the highest weekly sales since launching at the major retailer following the advertisement. We've also seen a significant increase in traffic to our websites. So, we do believe that the ads are working and we're getting more consumer awareness.

当然。所以,让我开始吧,这是杰森。所以,我将从沃尔玛问题和广告问题开始,然后我将库存问题交给比尔。所以关于沃尔玛,是的,我们将在第四季度推出。是的,我们对此感到非常兴奋。他们打算将产品放在所有沃尔玛商店中,我们认为这将是公司销售额的一个非常好的增长。我在之前的电话会议上说,历史上,CFC版本的Primatene,沃尔玛占销售额的35%。

所以我们很兴奋,他们似乎对产品感到兴奋,店内应该有一些好的促销,我们甚至可能会增加我们的一些广告,因为我们是 - 这是你的早期,但我们是看到广告正在发挥作用的非常好的迹象。我们看到销售额大幅增长。因此,我们从主要零售商和主要零售商之一获得了滞后的数据,我们看到自广告发布后在主要零售商推出以来的最高每周销售额。我们也看到我们网站的流量大幅增加。因此,我们确实相信这些广告正在发挥作用,我们正在获得更多的消费者意识。

比尔彼得斯

And to your question on stocking, if I had to characterize, the fourth quarter sales were entirely stocking. First quarter sales were primarily stocking with a little bit of reorders and this quarter was a little bit of stocking, but it was primarily reorders.

对于你关于放养的问题,如果我不得不描述,第四季度的销售完全是库存。 第一季度的销售主要是库存,只有一点点重新订购,而本季度只是一些库存,但它主要是重新订购。

加里·纳赫曼

Okay. And then for Enox, so, is this a normalized run rate now going forward? It was down significantly from 1Q. So, did you lose share or the price contract? And then G&A was a lot lighter like you said than 1Q. So, I just want to get a sense if that's a new run rate now that you have some of the litigation spend out of the way? Thank you.

好的。 然后对于Enox来说,这是一个现在正常化的运行率吗? 它从第一季度开始显着下降。 那么,你失去了份额还是价格合同? 然后G&A比你说的要轻得多,比第一季还要轻。 所以,我只是想了解一下,如果这是一个新的运行率,那么你现在有一些诉讼费用吗? 谢谢。

比尔彼得斯

So first of all on the enoxaparin, we did -- there is increased competition in the market now. So that took a toll and will continue to take a toll on both the number of units we sell and the pricing. So that did come down over the course of the quarter. So, there is that. On the G&A, our legal expenses will come down pretty significantly from where they were, especially in the first quarter, where they were very high, but we do have some increased spending on some compliance costs as well and that will ramp up a little bit more and offset part of that in the second.

首先关于依诺肝素,我们做了 - 现在市场上的竞争越来越激烈。 因此造成了损失并将继续对我们销售的单位数量和定价产生影响。 所以这一季度确实下降了。 所以,就是这样。 在G&A上,我们的法律费用将从相当大的水平下降,特别是在第一季度,它们非常高,但我们确实在一些合规成本方面有一些增加的支出,而且会增加一点点 更多,并抵消了第二部分。

会议主持员

Our next question comes from David Steinberg with Jefferies. Your line is now open.

我们的下一个问题来自David Steinberg和Jefferies。 你的生产线现已开放。

大卫斯坦伯格

Great. Thanks. I have a couple of questions. First on business development. I know that you have been an acquirer in the past but you typically had not used debt thankfully and equity but instead you've used cash. So, now you just got I think $50 million in cash and most of your transactions have been relatively small. So does this increase the likelihood of something near term? Does it increase your appetite? And if you are in fact looking for assets, what sort of pricing have you been saying the valuation is still high? And then just to clarify what Gary had asked before on Primatene and regarding Walmart, you said the launch would be in Q4, does that mean the load will also be in Q4 or the pipeline still be in Q3 for the Walmart Primatene? Thanks.

非常好。 谢谢。 我有一些问题。 首先是业务发展。 我知道你过去一直是收购者,但你通常没有使用债务,谢天谢地和股权,而是你用现金。 所以,现在你只需要5000万美元的现金,而且你的大部分交易都相对较小。 那么这会增加近期某些事情的可能性吗? 它会增加你的胃口吗? 如果您实际上正在寻找资产,那么您所说的估价仍然很高? 然后,为了澄清Gary之前在Primatene和沃尔玛问过的问题,你说发布将在第四季度,这是否意味着负载也将在第四季度或者管道仍然在第三季度为Walmart Primatene? 谢谢。

Jason Shandell

Sure. Yes. So, with respect to business development, we do have a strong balance sheet now and it does increase our appetite. We are seeing better valuations. We're very disciplined. When we do an acquisition, it has to be very synergistic. There are some opportunities out there. It's just the matter of valuation. So we're continuing to look and we'll provide updates as we go. For now though, obviously our core competency is organic growth and we do have some expensive clinical trials. So we'll put some of the money toward that. But yes, we definitely have increased our appetite for some business development at the right price and the right products that would be synergistic.

当然。 是。 因此,就业务发展而言,我们现在确实拥有强大的资产负债表,确实增加了我们的胃口。 我们看到更好的估值。 我们非常自律。 当我们进行收购时,它必须非常协同。 那里有一些机会。 这只是估值问题。 所以我们继续看,我们会随时提供更新。 目前,显然我们的核心竞争力是有机增长,我们确实有一些昂贵的临床试验。 所以我们会把一些钱用于此。 但是,是的,我们肯定已经增加了对合适价格的一些业务开发的兴趣以及合适的产品。

比尔彼得斯

And just to clarify, it was really closer to $60 million because we are utilizing the tax credit. We really did have a nice -- we'll have a nice cash flow in from that settlements. And as far as the load into Walmart goes, it's probably going to be a fourth quarter event.

而且只是为了澄清,它实际上接近6000万美元,因为我们正在利用税收抵免。 我们确实做得很好 - 我们从这些定居点获得了很好的现金流。 就沃尔玛的负荷而言,这可能是第四季度的事件。

大卫斯坦伯格

Okay. Just a couple of quick follow-ups. So on your gross margin, it looks like it was a decent clip weaker than perhaps one would expect. Any reasons for that? And secondly, you mentioned the PDUFA for -- in the second half of the year for that large undisclosed product. So just to ask you about that. Could you clarify the timing in the second half of the year? It's a big window. And secondly, in the past, you've described it I think is close to a $300 million product, off patent for a while, no generics. Has anything changed either in terms of, has there been a generic approved or is the sales size still about $300 million?

好的。 只需几次快速跟进。 所以在你的毛利率上,它看起来像是一个比人们预期的更弱的合适剪辑。 有什么理由吗? 其次,你提到了PDUFA - 在今年下半年,这个大型未公开的产品。 所以只是问你这个问题。 你能澄清一下下半年的时间吗? 这是一个很大的窗口。 其次,在过去,你已经描述过它,我认为它接近3亿美元的产品,暂时没有专利,没有仿制药。 是否有任何改变,是否有通用批准或销售规模仍然约3亿美元?

Jason Shandell

So. Sure. Yes. So that we have two PDUFAs in the second half of this year. The one is for the epinephrine. The other is for this large undisclosed product. We'd rather just keep a general since -- yes, at this point it's August. So, we have four months remaining. But in the next four months, we will have two PDUFA dates and we're excited by the possibility and perhaps the probability of getting both of these approved. So, those could be drivers. We are confident in the approvals. So we're trying to see if we could launch soon thereafter and then we can get sales for the fourth quarter, which would be great. And then with respect to the next question, I'll turn back to Bill.

所以。 当然。 是。 所以今年下半年我们有两个PDUFA。 一个是肾上腺素。 另一种是这种大型未公开的产品。 我们宁愿只留一个将军 - 是的,此时它是8月。 所以,我们还有四个月的时间。 但在接下来的四个月里,我们将有两个PDUFA日期,我们很高兴有可能,也许是获得这两个批准的可能性。 所以,那些可能是司机。 我们对批准信心十足。 因此,我们试图看看我们是否可以很快推出,然后我们可以获得第四季度的销售,这将是很好的。 然后关于下一个问题,我将回到比尔。

比尔彼得斯

Gross margins, yes. So, on the gross margin, it is higher than we had been experiencing. So we did have higher sales of products that were higher margin products like the Primatene and the [Indecipherable] medroxyprogesterone. But then we did have a little more weakness on enoxaparin this quarter with that price coming down and also the naloxone price coming down a little bit. So, there was definitely some offset there. But just take a look at the drivers of growth for the rest of this year and the quarters to come, we expect Primatene Mist to keep ramping up and that's very high gross margin product. And we expect that the new products that we hope to launch the two products that have PDUFA dates later this year, we would expect to have both of those have very high gross margins as well. So, we think that that gross margin trend continues to go up as we go on.

毛利率,是的。 因此,在毛利率方面,它高于我们的体验。 因此,我们确实拥有更高产量的产品销售,这些产品是Primatene和[Indecipherable] medroxyprogesterone等高利润产品。 但是,本季度我们确实对依诺肝素有了更多的弱点,这个价格下降,纳洛酮的价格也有所下降。 所以,肯定有一些抵消。 但是,只要看看今年剩余时间和未来几个季度的增长动力,我们预计Primatene Mist将继续增长并且这是非常高的毛利率产品。 我们希望我们希望在今年晚些时候推出具有PDUFA的两种产品的新产品,我们预计这两种产品的毛利率也会非常高。 因此,我们认为随着我们的继续,毛利率趋势继续上升。

会议主持员

Our next question comes from David Amsellem from Piper Jaffray. Your line is now open.

我们的下一个问题来自Piper Jaffray的David Amsellem。 你的生产线现已开放。

David Amsellem

Thanks. So I joined late, so you might have addressed this already, but just an update on the specific inhalation products in the pipeline and the -- and your thoughts on filings for later this year? And just thinking higher level, this is more beyond this year is how we should think about the pace of filings or the advancement of inhalation products? I mean, you have Primatene but how should we think about the longer term expansion of the inhalation portfolio? Last question on Depo-Provera, the generic, just any color on the competitive dynamics there and where you think that product will trend back half of the year and into next year. Thanks.

谢谢。 所以我很晚才加入,所以你可能已经解决了这个问题,但只是对管道中特定吸入产品的更新和 - 以及你对今年晚些时候申请的想法? 只是想到更高的水平,今年更多的是我们应该如何考虑申请的速度或吸入产品的进步? 我的意思是,你有Primatene,但我们应该怎样考虑吸入组合的长期扩张? 关于Depo-Provera的最后一个问题,通用,只是竞争动态的任何颜色,你认为该产品将在今年的一半和明年的趋势。 谢谢。

Jason Shandell

Sure. Yes. I was wondering if anyone would pick up on actually what was a new disclosure related to our first inhalation ANDA. For competitive reasons, we've always been pretty close to the vest on that and have never disclosed whether it's dry powder or a metered dose inhalers. So, today in my prepared remarks, I did say that it will be an HFA metered dose inhaler. So that's, as everyone knows, that's an area of expertise for Amphastar. We've got a lot of expertise in -- with Primatene in terms of reformulating the CFC to HFA. And so that is something new that we've disclosed that it is an HFA MDI.
Now on the last call, we had discussed filing it late this year, but in my prepared remarks, I was discussing that we have an ongoing clinical trial, and after further discussions with the FDA, we decided to increase the number of subjects in order to provide more confidence in meeting the endpoints. So now we're making good progress, but we are now forecasting to file that ANDA in 2020 as opposed to the end of 2019.
And then, let's see -- in terms of the sort of the future of the pipeline, we want to keep a similar cadence to what we've had over the last couple of years. So what we're seeing is about three approvals, our hope is to get to two to three approvals on an annual basis and then we're looking to file on an annual basis approximately three products every year. And we think for a company of our size, given the complexity and the large markets that these products are focusing on, it will be very large opportunities for a company with our market cap. And then finally...

当然。是。我想知道是否有人会接受与我们第一次吸入ANDA有关的新披露。出于竞争原因,我们一直非常接近背心,并且从未透露它是干粉还是计量吸入器。所以,今天在我准备好的评论中,我确实说它将是一种HFA计量吸入器。所以,众所周知,这是Amphastar的专业领域。我们有很多专业知识 - 使用Primatene将CFC重新配制为HFA。所以我们已经披露它是一种新的HFA MDI。

现在在最后一次电话会议上,我们讨论了今年晚些时候提交的文件,但在我准备好的评论中,我正在讨论我们正在进行的临床试验,在与FDA进一步讨论之后,我们决定按顺序增加主题数量。为满足端点提供更多信心。所以现在我们正在取得良好进展,但我们现在预测在2020年提交ANDA而不是2019年底。

然后,让我们看一下 - 就管道的未来而言,我们希望保持与过去几年中我们所拥有的相似的节奏。所以我们看到的是三个批准,我们希望每年获得两到三个批准,然后我们希望每年提交大约三个产品。我们认为对于我们这样规模的公司而言,考虑到这些产品所关注的复杂性和大市场,对于拥有市值的公司来说,这将是非常大的机会。最后......

David Amsellem

Specifically on inhalation through -- on inhalation, I is that going to be more of the filing mix.

特别是在吸入吸入时,我会更多的是填充混合物。

Jason Shandell

Yes. So we are focused right now -- I talked a lot about this one MDI that has got ongoing right now in the clinical trial targeting filing that next year. There is another inhalation product that we're working on in parallel. So that will be part of the mix as well. But as you know, we've got a large number of inhalation and you'll see more of those coming into the mix next year and 2021.
And then the generic Depo-Provera, there is more competition in the market, but we've always felt this is a great product to produce because it's so difficult to manufacture and so we think we have a really good process in place that will allow us to produce quality product for many years to come. So we do expect as a generic company to see more competition, but we think we can strongly compete, especially with respect to this product.

是。 所以我们现在关注的是 - 我谈到了很多关于这一个MDI的信息,这个MDI目前正在进行针对明年提交申请的临床试验。 还有另一种我们正在同时进行的吸入产品。 所以这也将是混合的一部分。 但是如你所知,我们吸入了大量的气体,明年和2021年你会看到更多的吸入。

然后是通用的Depo-Provera,市场上有更多的竞争,但我们一直认为这是一个很好的产品,因为它很难制造,所以我们认为我们有一个非常好的工艺,允许 我们将在未来许多年内生产出优质产品。 因此,我们希望作为一家仿制药公司能够看到更多的竞争对手,但我们认为我们可以进行激烈的竞争,尤其是对于这种产品。

David Amsellem

Okay. Thanks.

好的。 谢谢。

会议主持员

Our next question comes from Serge Belanger with Needham. Your line is now open.

我们的下一个问题来自Serge Belanger和Needham。 你的生产线现已开放。

田孙

Hey, thanks for the question, guys. This is Tian on for Serge. So besides Walmart, which you secured for the fourth quarter, is there any other retailers that you're looking at, big discount retailers or even supermarkets that you're looking for? And then in terms of the independent pharmacies and the smaller chain pharmacies, how big are these markets relative to the big three pharmacies like CVS, Walgreens and Rite Aid? And then lastly, I think you mentioned about online sales of permitting. So do you have any breakdown in terms of sales of in-store versus online that you're expecting to reach in the near future? Thank you.

嘿,谢谢你的问题,伙计们。 对于塞尔来说这是田。 除了你在第四季度获得的沃尔玛之外,还有其他任何你正在寻找的零售商,大型折扣零售商甚至是你正在寻找的超市吗? 然后就独立药店和小型连锁药店而言,这些市场相对于CVS,Walgreens和Rite Aid等三大药店有多大? 最后,我想你提到了许可的在线销售。 那么,您预计在不久的将来会在店内销售与在线销售方面有任何细分吗? 谢谢。

Jason Shandell

Sure. Yes. So we're really excited by Walmart. I mean, as I said earlier, that made up 35% historically of our sales. And so when it comes to the independent pharmacies, we're exploring all avenues. We want to get this out across the board online independent pharmacies. We are in discussions with other large retailers and groceries. But really we see it is like the 80/20 rule. You get Walmart, CVS, Walgreens and that's a huge percentage of the market, but we are exploring all opportunities, including in the long run Amazon as well. So we see this as a very exciting product and are very encouraged by the upcoming launch to Walmart.

当然。 是。 所以我们对沃尔玛非常兴奋。 我的意思是,正如我之前所说,在历史上我们的销售额占35%。 因此,当涉及到独立药房时,我们正在探索所有途径。 我们希望全面了解这个在线独立药房。 我们正在与其他大型零售商和杂货进行讨论。 但实际上我们看到它就像80/20规则。 你得到沃尔玛,CVS,沃尔格林,这是市场的一个很大的比例,但我们正在探索所有的机会,包括长期以来的亚马逊。 所以我们认为这是一个非常令人兴奋的产品,并且即将推出的沃尔玛非常鼓舞。

会议主持员

At this time, I'm showing no further questions. I would like to turn the call back over to Jason for any closing remarks.

这时,我没有再问任何问题了。 我想把这个电话转回杰森的任何结束语。

Jason Shandell

Thank you, operator. I want to thank everyone again for joining us today. We are pleased with the progress that we've recently made and remain confident in achieving our long-term goals and enhancing shareholder value. We look forward to talking with you in the future and hope everyone has a great day.

谢谢运营商。 我想再次感谢大家今天加入我们。 我们对最近取得的进展感到高兴,并对实现我们的长期目标和提高股东价值保持信心。 我们期待在未来与您交谈,并希望每个人都度过美好的一天。

会议主持员

Ladies and gentleman thank you for your participation in today's conference. This does conclude the program and you may now disconnect. Everyone have great day.

女士们,先生们,感谢您参加今天的会议。 这确实结束了程序,您现在可以断开连接。 每个人都有美好的一天。

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